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Manitoba Transfusion Quality Manual for Blood Banks

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					    Manitoba
  Transfusion
 Quality Manual
for Blood Banks
     June 2007
Production of this manual has been possible through a financial contribution from the Public
Health Agency of Canada

The views expressed herein do not necessarily represent the views of the Public Health
Agency of Canada.




     Contact/ Ordering Information
     Diagnostic Services of Manitoba Inc.
     Attention: Office of Provincial Director of Quality
     1502-155 Carlton St.
     Winnipeg, Manitoba R3C 3H8
     Phone (204) 926-8005
     Fax (204) 940-1761
     E-mail: contact@dsmanitoba.ca




Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks
               IntroductIon
Introduction
Introduction

This manual is the product of a remarkable combination of talent, dedication, hard work
and patience. This second edition of the manual has been extensively re-written and
updated to reflect best practice for Blood Bank technologists. The manual is designed
as a tool to assist with daily laboratory practice. It is not a replacement for experience,
sound judgement, or common sense.
This project was initiated and managed by the Manitoba Provincial Blood Programs
Coordinating Office and funded in part by a grant from the Public Health Agency of
Canada. This grant funding is part of the national transfusion transmitted injuries
surveillance system TTISS. We thank PHAC for their continued support of this and
other quality improvement initiatives.
The first edition of this manual was adapted from a best practice manual developed
British Colombia Provincial Blood Programs Coordinating Office. We are grateful for
the expertise and assistance offered by our colleagues in BC.
This manual could not have been produced without the experts listed on the following
page. Thanks to all who contributed their time and experience.


Dr. Ian Wilkinson BS, MS, PhD, DClinChem, FACB, MBA
Chair, Transfusion Medicine Quality Improvement Working Group,
Manitoba Provincial Blood Programs Coordinating Office
Manitoba Health


June, 2007




Version 2 • June 2007                      Manitoba Transfusion Quality Manual for Blood Banks
                                  Acknowledgements
                        This manual was developed by the following people.
              We are grateful for their time, expertise and dedication to this initiative.



   Transfusion Medicine                     Nursing Writing Group	
   Quality Improvement                      Cheryl Bennett, Winnipeg RHA
   Working Group                            Roz Evason, Brandon RHA
   Clarice Baker, College of Physicians     Judy Gabler, Assiniboine RHA
      & Surgeons of Manitoba
                                            Marilynne Hogg, Winnipeg RHA
   Pat Bird, Interlake RHA
                                            Bijou Howatt, Nor-man RHA
   Judy Boland, Canadian Blood Services
                                            Donna Lair, Parkland RHA
   Robert Fallis, Canadian Blood Services
                                            Lois Moberly, Nor-man RHA
   Sherry Filipchuk, Parkland RHA
                                            Maureen Monzcka,
   Lee Grabner, Canadian Blood Services        CancerCare Manitoba
   Susan Henderson, Winnipeg RHA            Linda Sutherland, Interlake RHA
   Sue Kirkey, Burntwood RHA                Deb Weir, Central RHA
   Diane Kirkwood, Assiniboine RHA
   Nicole Lafreniere, South Eastman RHA     Nursing Resource Group
   Barb Lyons, Nor-man RHA                  Shirley Bezditny, South Eastman RHA
   Donalee Mansfield, Brandon RHA           Jenny Billey, CancerCare Manitoba
   Brenda Meers, Central RHA                Deb Elias, College of Registered
                                               Nurses of Manitoba
   Benita Nylen, Assiniboine RHA
                                            Nicole Harder, Faculty of Nursing,
   Cathy Rudd, Central RHA       	
                                               University of Manitoba
   Brian Webber, North Eastman RHA
                                            Elizabeth Hextall, Brandon RHA
   Theresa Wiwchar, Diagnostic
                                            Rose Jacobson, Manitoba Bleeding
      Services of Manitoba
                                               Disorders Program
   Medical Consultants                      Susan Kenny, WRHA Perioperative
   Dr. Debra Lane,                             Blood Conservation Program
      Canadian Blood Services               Dianne Mestdagh, Interlake RHA
   Dr. Catherine Moltzan,                   Nora Schwetz, Manitoba Bleeding
      Diagnostic Services of Manitoba          Disorders Program
                                            Tracy Robinson, Winnipeg RHA
   Manitoba Health Provincial Blood
                                            Kathy Stewart, Brandon RHA
   Programs Coordinating Office
                                            Michelle Vezina, North Eastman RHA
   Carol Renner
                                            Kathy Ward, Brandon RHA
   Barbara Kraft
   Lori Sul
   Linda Bouchard
   Susan Turnbull
   Dr. Ian Wilkinson
   *Lorna Feindel, Nursing Consultant



                                                                                *Deceased August 7, 2007




Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks
Table of Contents




                    Table of ConTenTs
   Manitoba	Transfusion	Quality	Manual	for	Blood	Banks
                   Table	of	Contents

      Introduction
      Acknowledgements
      Module 1: Administration
          (Under development by Diagnostic Services of Manitoba)
      Module 2: Pre-Transfusion Testing (Non-Crossmatch)
          Table of Contents – Module 2 (Non-Crossmatch)
          Patient Identification and Specimen Procurement ........................................MP.001
          Specimen Acceptance/Rejection and Suitability .............................................MP.002
          Handling Outdated Type and Screens/ Patient Assigned Units .....................MP.016
          Specimen Referral .............................................................................................MP.017
          Emergency Issue of Donor Red Cells Units ......................................................MP.018
          Transfusion Reaction Investigation (Non-Crossmatch) ...................................MP.020
      Module 2: Pre-Transfusion Testing (Crossmatch)
          Table of Contents – Module 2 (Crossmatch)
          Patient Identification and Specimen Procurement ........................................MP.001
          Specimen Acceptance/Rejection and Suitability .............................................MP.002
          Patient History Files ..........................................................................................MP.003
          Specimen Centrifugation .................................................................................MP.004
          Labelling Tubes/ Gel Cards and Block Set Up ..................................................MP.005
          Preparing Red Cell Suspensions .......................................................................MP.006
          Reading and Recording Hemagglutination Reactions: Tube and Gel ...........MP.007
          ABO Testing.......................................................................................................MP.008
          Rh Testing ..........................................................................................................MP.009
          Cell Washing for Antiglobulin: Automated and Manual ...............................MP.010
          Indirect Antiglobulin Test.................................................................................MP.011
          Indirect Antiglobulin Test – Gel Method ......................................................MP.011A
          Indirect Antiglobulin Test – Saline Method ................................................. MP.011B
          Indirect Antiglobulin Test – PEG Method ..................................................... MP.011C


Table	of	Contents
Version 2 • June 2007                                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 4
          Antibody Screen Reporting ..............................................................................MP.012
          Immediate Spin Crossmatch .............................................................................MP.013
          Determining Compatibility of Donor Red Cell Units ......................................MP.014
          Pre-Transfusion Testing Requirements for Neonates
          (Small Volume Red Cell Transfusion) ...............................................................MP.015
          Handling Outdated Type and Screens/ Patient Assigned Units .....................MP.016
          Specimen Referral .............................................................................................MP.017
          Emergency Issue of Donor Red Cells Units ......................................................MP.018
          Issuing Donor Red Cells Prior to Completion of Pre-Transfusion Testing ......MP.019
          Transfusion Reaction Investigation (Crossmatch) ...........................................MP.020
      Module 3: Inventory Management
          Table of Contents – Module 3
          Blood, Blood Component and Derivative Inventory Management ..............INV.001
          Storage of Blood, Blood Components and Derivatives .................................INV.002
          Ordering Blood, Blood Components and Derivatives ...................................INV.003
          Receiving Blood, Blood Components and Derivatives ..................................INV.004
          Visual Inspection of Blood, Blood Components and Derivatives ..................INV.005
          ABO/Rh Confirmation Testing: Red Cell Units (Crossmatch Facilities) ..........INV.006
          Issuing, Returning and Documenting Final Disposition
          of Blood, Blood Components and Derivatives ...............................................INV.007
          Transport of Blood, Blood Components and Derivatives
          (Within a Facility) .............................................................................................INV.008
          Inter-facility Shipping of Blood, Blood Components and Derivatives ..........INV.009
          Documenting the Final Disposition of Returned or Discarded
          Blood, Blood Components and Derivatives ...................................................INV.010
          Selection of Blood and Blood Components for Transfusion .........................INV.011
          Thawing Frozen Plasma Components ............................................................INV.012
          Tagging Blood, Blood Components and Derivatives .....................................INV.013
          Tagging Divided Red Cells Units for Neonatal Protocol .............................INV.013.1




                                                                                                               Table	of	Contents
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      Module 4: Quality Control
          Table of Contents – Module 4
          Storage Equipment Standards: Blood, Blood
          Components and Derivatives ...............................................................QC.001 Policy
          Temperature Monitoring: Blood, Blood Component
          and Derivative Storage Equipment .............................................................. QC.001A
          Alarm System Check: Blood, Blood Component
          and Derivative Storage Equipment .............................................................. QC.001B
          Equipment Maintenance ............................................................................... QC.001C
          Alarm Response/Malfunction: Blood, Blood Component
          and Derivative Storage Equipment .............................................................. QC.001D
          Refrigerator Malfunction Instructions .......................................QC.001D Job Aid 1
          Freezer Malfunction Instructions ................................................QC.001D Job Aid 2
          Platelet Incubator Malfunction Instructions ..............................QC.001D Job Aid 3
          Testing Equipment Standards ..............................................................QC.002 Policy
          Calibration Incubator: Waterbath/Heating Block/Plasma Thawer.............. QC.002A
          Calibration: Serologic Centrifuge ................................................................. QC.002B
          Verification of Non Reference Thermometers ............................................. QC.002C
          Calibration: Pipette ....................................................................................... QC.002D
          Temperature Monitoring Incubator: Waterbath/Heating Block/
          Plasma Thawer ..................................................................................................QC.003
          Receiving Reagents ...........................................................................................QC.004
          Quality Control of Reagents: Using a Commercial QC Kit .............................QC.005
      Module 5: Supplemental Testing
          Table of Contents – Module 5
          Specimen Requirements and Recommended Test Schedule –
          Manitoba Rh Program ....................................................................................... ST.001
          Neonatal Testing for HDN and Maternal RhIG Eligibility................................ ST.002
          Weak D Typing ................................................................................................... ST.003
          Pre-warm Technique .......................................................................................... ST.004
          ABO Problem Solving ........................................................................................ ST.005
          Rh Typing Problem Solving ............................................................................... ST.006
          Direct and Indirect Antigen Typing .................................................................. ST.007
          Saline Addition and Replacement Technique .................................................. ST.008
          Routine Antibody Investigation ....................................................................... ST.009
          Direct Antiglobulin Test ................................................................................... ST.010

Table	of	Contents
Version 2 • June 2007                                        Manitoba Transfusion Quality Manual for Blood Banks • 3 of 4
      Forms
      Appendices
          Abbreviations ........................................................................................... Appendix 1
          Facility Contact List .................................................................................. Appendix 2
          Glossary .................................................................................................... Appendix 3
          Products used by Manitoba Bleeding Disorders Program ..................... Appendix 4
          Product Descriptions ................................................................................ Appendix 5
          Product Mnemonics ................................................................................. Appendix 6
          Progesa Codes and Mnemonics .............................................................. Appendix 7
          Record Retention ..................................................................................... Appendix 8
          Symbols, Factors and Greek Letters ........................................................ Appendix 9
      FAQ and Study Guide
      References




                                                                                                               Table	of	Contents
4 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                                              Version 2 • June 2007
Module 1




           Module 1
Module	1:	Administration
Contact Information / Technical and Medical Support
[1] Non-Urgent Medical, Technical And Administrative Issues
To be contacted for non-urgent medical, technical and administrative issues related to the
transfusion medicine discipline.
Medical Director:       Dr. Catherine Moltzan
                        L1-101-20 St. Boniface General Hospital
                        409 Tache Ave
                        Winnipeg, MB
                        R2H 2A6
                        (204) 235-3924
                        FAX (204) 237-6048
                        catherine.moltzan@cancercare.mb.ca
Technical Director: Theresa Wiwchar
                    c/o St. Boniface General Hospital
                    409 Tache Ave
                    Winnipeg, MB
                    R2H 2A6
                    (204) 237-2707
                    FAX: (204) 237-2494
                    twiwchar@sbgh.mb.ca

[2] Emergent And Urgent Medical Issues
As of 30 July 2007 at 08:00 hours an integrated physician transfusion medicine call
schedule was made available. There is a pathologist on-call 24 hours a day, seven days a
week to address emergent and urgent medical issues related to DSM blood banks and
to transfusion medicine. The call schedule will be distributed on a monthly basis through
DSM administration, with contact information (office phone numbers, pager numbers,
cell phone numbers and home phone numbers) for the pathologist on-call.
If there is difficulty in contacting the physician-on-call, contact Health Sciences Centre
paging (204) 787-2071 who will have the updated call schedule list. Sometimes there are
changes to the call schedule that occur after the original call schedule is distributed.




Module	1
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 1
Module 2: Non-Crossmatch




                           Module 2: NoN-CrossMatCh
  Module	2:	Pre-Transfusion	Testing	(Non-Crossmatch)
                  Table of Contents
      Patient Identification and Specimen Procurement ........................................MP.001
      Specimen Acceptance/Rejection and Suitability ............................................MP.002
      Handling Outdated Type and Screens / Patient Assigned Units .................MP.016
      Specimen Referral ...............................................................................................MP.017
      Emergency Issue of Donor Red Cells Units ....................................................MP.018
      Transfusion Reaction Investigation (Non-Crossmatch) ................................MP.020




Module	2	(Non-Crossmatch)		•	Table	of	Contents
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks
                                       MP.001		
          Patient Identification and Specimen Procurement


1.0 Principle
To positively identify a patient, and accurately label specimens that are used for
pre-transfusion testing.
NOTE: Most hemolytic transfusion reactions result from errors in patient or specimen
identification, therefore the transfusion service shall accept only specimens with
complete, accurate and legible labels.

2.0 Scope and Related Policies
      2.1 Only authorized, trained individuals shall collect specimens.
      2.2 Request forms for specimen collection and/or blood components, and any other
          documentation accompanying blood specimens from the patient, shall contain
          sufficient information to allow for positive identification of the intended patient.
      2.3 There shall be unequivocal identification of the intended patient before drawing
          blood specimens using the patient’s armband or Provincial Health Card.
          This shall include verification of:
          • The patient’s last and first name, and
          • Personal Health Identification Number (PHIN), or
          • Unique identifier, if there is no PHIN.
      2.4 Each facility must have a system for patient identification for unidentified
          patients.
      2.5 Should inaccuracies or discrepancies be discovered during the identification
          process, blood specimens shall not be collected until the matter has been
          satisfactorily resolved.
      2.6 Blood specimens shall be labelled in the patient’s presence. The label shall be
          completed with the patient’s name, PHIN (or unique identifier) and date of
          collection and attached to the specimen tube before leaving the patient’s side.
      2.7 All specimen labels and request forms must be complete, accurate and legible.
          • Changes shall not be made to patient identification on either the specimen
            label(s) or the request form once the specimen has been received in the BTS
            laboratory.
          • A new specimen shall be collected if any discrepancy exists.
      2.8 Specimen tubes must not be over-labelled when mistakes are detected on the
          original label.




Module	2	(Non-Crossmatch)		•	MP.001
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 4
3.0 Materials
Requisition (or electronic order) showing the patient’s last and first name and unique
identifier (PHIN).
Pre-printed specimen labels (i.e. computer or addressograph) if available.
Materials for specimen collection as per facility procedure(s):
NOTE: Volumes given below are for adult patients. For neonatal and pediatric patients,
refer to facility guidelines for specimen collection procedures and volumes.
Type and Screen/Crossmatch:
• Request for Blood Components (XM101) or appropriate BTS request form
• Appropriate EDTA specimen (volume as per request form)
• A Fax notification form (CM 077) as applicable
Antibody Investigation:
• Request for Miscellaneous Testing (XM 104) or appropriate BTS request form
• Appropriate EDTA specimen (volume as per request form)
Transfusion Reaction Investigation:
• Transfusion Reaction Investigation Form (CM105)
• Appropriate EDTA specimen (refer to MP.020 Transfusion Reaction Investigation)
Pre and Post-Natal Testing:
• Request for Pre and Post-Natal Testing (Rh.101)
• Appropriate clotted and EDTA specimen (volume as per request form)
Cord Blood Testing:
• Request for Cord Blood Testing (Rh.105)
• Appropriate EDTA specimen (volume as per request form)
• Refer to procedural note 6.2
All other testing:
• Consult BTS or CBS Accession Laboratory for specimen amount and requisition
• Protective covering (e.g. ziplock bag) for specimens is recommended for “in-hospital”
transport.

4.0 Procedure
      4.1 Ensure a request form is prepared with the correct information.
          The request form shall include the following information:
          • Patient’s last and first name
          • A PHIN or unique identifier if there is no PHIN
          The request form should include the following information:
          • Facility name
          • Patient location
          • Facility medical record number (MRN)
          • Patient’s date of birth
          • Treatment Order
          • Name of ordering physician/authorized practitioner


                                                                  Module	2	(Non-Crossmatch)		•	MP.001
2 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                    Version 2 • June 2007
          • Intended date and time of transfusion/infusion
          • Diagnosis and reason for transfusion/infusion
          • Priority
          • Special handling requirements
          • Transfusion/infusion history
      4.2 Confirm that there is a patient identification band physically attached to the
          patient (i.e. not to the bed, wall or the door).
          • If the patient is an inpatient or is admitted to emergency and does not have an
            identification band, have nursing positively identify patient according to facility
            policy, ensure that an identification band is prepared and the band is attached
            to the patient prior to collection.
            NO BAND – NO BLOOD
            NOTE: If the patient’s clinical condition prohibits physical placement of an
            identification band on the patient, the patient must be positively identified by
            their primary caregiver.
            • If the patient is an outpatient ensure positive identification of patient using a
              Manitoba Health Card (PHIN) or unique identifier.
      4.3 Before collecting the specimen, ask the patient to spell his/her last and first name
          and give date of birth (Do not say, “Are you…?”). As the patient is spelling their
          name and date of birth, compare letter by letter and number by number to the
          corresponding information on the requisition.
          If the patient is unable to communicate his/her name, ask a qualified person,
          e.g. the patient’s nurse, to identify the patient and sign the requisition before
          collecting the specimen(s).
      4.4 Compare the patient’s last and first name and PHIN or unique identifier on the
          request form and patient identification band. They must be identical.
          • Any discrepancy must be resolved by the ward or Health Records before
            performing the venipuncture.
      4.5 Perform specimen collection as per established facility procedure(s) following
          routine practices for infection control.
      4.6 Label the specimen immediately after performing the venipuncture, before
          leaving the patient’s side.
          • Indelible ink must be used for handwritten labels
          4.6.1 The specimen label must include:
                • Patient’s last and first name
                • PHIN or unique identifier
                • Date and time of collection
                • Facility name, if applicable
                • Initials of the phlebotomist




Module	2	(Non-Crossmatch)		•	MP.001
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 3 of 4
           4.6.2 Complete the requisition with:
                 • Phlebotomist’s printed name, initials and classification
                 • Date and time of collection
                 • Facility name where specimen is drawn
                 • Facility name where blood, blood component and derivative is to be sent
        4.7 Perform a final check before leaving the patient’s side. Confirm that the patient’s
            last and first name and PHIN or unique identifier are identical on:
            • Specimen tube label(s)
            • Request form
            • Patient identification band
           Corrections may only be made to the specimen tube label at this time:
           • Put a single line through the error
           • Make the correction
           • Initial the change
5.0 Reporting
        N/A

6.0 Procedural Notes
        6.1 If unsure of required specimen volume, contact BTS or CBS for direction.
        6.2 When sending cord blood specimen, ensure maternal specimen and requisition
            is sent.



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	         	     	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	     	       	        	        	        	
    Facility	effective	date:			__________________________________
    	         	     	       									(Date	of	implementation)




                                                                             Module	2	(Non-Crossmatch)		•	MP.001
4 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                          MP.002		
          Specimen Acceptance / Rejection and Suitability


1.0 Principle
      To describe the criteria for the acceptance/rejection and suitability of specimens used
      for pre-transfusion/testing.

2.0 Scope and Related Policies
      2.1 Only complete, accurate and legibly labelled specimens and requisitions received
          in the blood bank/BTS shall be accepted for pre-transfusion/testing.
      2.2 Suitability of specimen(s) will be determined according to established criteria.

3.0 Materials
      Request form
      Specimen(s)

4.0 Procedure
      4.1 Compare the label(s) on the specimen(s) and the corresponding request form
          to ensure the following information is identical:
          4.1.1 Patient’s last and first name
          4.1.2 Patient’s PHIN or unique identifier
                • No corrections can be made to the specimen label.
                • Collect a new specimen if any of the above information is missing or
                  incorrect.
                • Complete an occurrence report according to facility procedure(s) and
                  submit it to a supervisor.
          4.1.3 Date/time of collection
                • No corrections can be made to the specimen label.
                  Obtain information from the phlebotomist, if missing, and document
                  on the specimen label and request form.
          4.1.4 Name of the phlebotomist
                • The phlebotomist must print their full name and initials on the request
                  form. Initials on specimen label are preferred but not mandatory.
                • Collect a new specimen if the phlebotomist is not available to complete
                  the request form.




Module	2	(Non-Crossmatch)		•	MP.002
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
      4.2 Check all pages of the request form for accuracy and legibility of the following
          information:
                • Patient’s date of birth
                • Facility name
                • Patient location
                • Test and product order
                • Intended date of transfusion/infusion
                • Ordering physician/authorized practitioner
                • Diagnosis and/or reason for transfusion/infusion
                • Priority
                • Transfusion/infusion history, if applicable
          4.2.1 Obtain any missing information.
          4.2.2 Obtain a new requisition if the addressograph on page one is not identical
                to the addressograph on page two.
      4.3 Assess the age of the specimen.
          4.3.1 Confirm the date of collection and the intended date of transfusion/infusion
                are within the acceptable time period.
                • Arrange to have another specimen collected, if unsuitable.
          4.3.2 The specimen must be collected from the patient within 3 days prior to a
                scheduled transfusion.
                • Day “0” is the date of collection.
                Example: For a 3 day outdate, a specimen collected on April 10 may be used
                for pre-transfusion testing up to midnight on April 13.
          4.3.3 Pre-Admission Clinic (PAC) specimens can be collected up to 21 days prior to
                scheduled operating room (OR) date, unless the patient:
                • Has been transfused with a blood component containing red cells within
                  the previous 3 months.
                • Has been pregnant within the previous 3 months.
                • Patient history is questionable or unavailable.
                  NOTE: ‘PAC specimens’ day “0” is the date of the surgery.
                • Eligibility for PAC is determined by the screening nurse or physician/
                  authorized practitioner.
      4.4 Specimens for type and screen and crossmatch will outdate at midnight, 3 days
          from the date of collection.
          4.4.1 If red cells are required after 3 days, a new specimen must be collected and
                a type and screen performed on the new specimen.
          4.4.2 If red cells are required urgently before a new specimen is collected or
                before a type and screen can be completed, red cells must be issued as
                unmatched and the BTS must be notified.




                                                                     Module	2	(Non-Crossmatch)	•	MP.002
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                      Version 2 • June 2007
       4.5 In some rural facilities, a 7 day outdate may be applied as determined by
           the Canadian Blood Services Crossmatch Laboratory (or 3 days following the
           transfusion of the first unit).
       4.6 Reject specimens for the following additional reasons:
          • Specimen is grossly hemolyzed.
          • Specimen appears contaminated with IV fluid.
          • Specimen is grossly contaminated with blood on the outside.
          • Specimen has not been collected in a lavender top EDTA tube.
          • Letters or numbers are overwritten rendering them illegible.
          • There is an error(s) in the collection date on the specimen tube.
          • Specimen is over-labelled and the information on the label underneath does
            not clearly identify that the specimen was collected from the same patient.
                 • For example, “Smith, Bill Initials “ on the label underneath and “Smith,
                   William” written on the upper label is acceptable.
                 • “Smith Initials, Marie” on the label underneath and “Jones, Marie” on the
                   upper label is not acceptable.
          • Specimen information has been corrected and the correct information does
            not clearly identify that the specimen was collected from the same patient.
                 • e.g.,” Smith Initials, Marie” on the label that has been corrected to “Jones,
                   Marie” is not acceptable.
                 • Name on the requisition has a first initial and middle name, e.g.,“R. John”
                   and the specimen is labelled with the middle name only, e.g., “John” is
                   not acceptable.
          • Specimen label has been altered using “white out”.
          • Specimen is not labelled with indelible ink.
       4.7 Specimens should be stored at 1°C to 8°C.

5.0 Reporting
       N/A

6.0 Procedural Notes
       N/A


   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	      											__________________________________	     __________________________________
   	         	        	       												(Senior	Management)	    	      	       		(Senior	Management)
   	         	        	       	            	       	      	
   Facility	effective	date:			__________________________________
   	         	        	       									(Date	of	implementation)


Module	2	(Non-Crossmatch)	•	MP.002
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                        MP.016		
Handling Outdated Type and Screens / Patient Assigned Units


1.0 Principle
     1.1 To ensure the cancellation of all type and screen specimens and/or crossmatched
         units when outdated or cancelled prior to outdate.
     1.2 To ensure crossmatched units that expire during the specimen indate period
         are discarded.
     1.3 To ensure all other patient assigned blood components are cancelled or
         discarded.

2.0 Scope and Related Policies
     2.1 Type and screen specimen(s) and/or crossmatched units which have not been
         transfused within the specimen indate period must be cancelled.
     2.2 Crossmatched units that expire during the specimen indate period must be
         cancelled and discarded according to facility policy.
     2.3 The indate period for type and screens and/or crossmatched units is as per
         MP.002.
     2.4 Type and screens and/or crossmatched units may be cancelled prior to expiry.
     2.5 All other patient assigned blood components must be cancelled or discarded,
         as required.

3.0 Materials
     Type and screen specimen
     Labelled/tagged/assigned blood and blood components
     Issue/Transfusion Record (lab log)
     BTS Patient Report (if applicable)

4.0 Procedure
     4.1 Identify cancelled type and screen specimen(s) and assigned unit(s).
         4.1.1 Non-Crossmatch facilites:
               • Remove unit(s) from storage and complete the disposition portion of the
                 Issue/Transfusion Record (lab log) for each unit. Refer to Module 3 INV.010.
               • Remove the chart and/or blood bank copy of the tag from the unit. File or
                 discard, as applicable.
               • Discard or return units to BTS as per facility policy.




Module	2	(Non-Crossmatch)	•	MP.016
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
           4.1.2 Crossmatch facilites:
                • If no products transfused, remove and discard outdated specimen.
                • If products transfused, retain specimen for a minimum of 7 days
                  post-transfusion.
                • Remove unit(s) from storage and complete the disposition portion of the
                  Issue/Transfusion Record (lab log) for each unit. Refer to Module 3 INV.010.
                • Remove the chart and/or blood bank copy of the tag from the unit. File
                  or discard, as applicable.
                • Discard or return units to inventory as per facility policy.

5.0 Reporting
        5.1 The chart copy of the type and screen and/or crossmatch report shall be sent to
            the appropriate ward to be placed on the patient’s health care record.
        5.2 The BTS laboratory copy of the report and worksheet shall be filed in accordance
            with the current edition of applicable standards.

6.0 Procedural Notes
        6.1 Autologous and directed units shall be used exclusively for the designated patient
            and shall not be crossed over into the allogeneic blood supply.



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)




                                                                              Module	2	(Non-Crossmatch)	•	MP.016
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                        MP.017		
                                     Specimen Referral


1.0 Principle
     To provide guidelines for packaging and referring specimens to a Blood Transfusion
     Service (BTS).

2.0 Scope and Related Policies
     2.1 BTS or CBS must be notified when a STAT request is being sent.
     2.2 Specimen(s) must be labelled according to MP.001.
         • Incorrectly or incompletely labelled specimens will not be tested.
     2.3 All specimens must be packaged according to Transportation of Dangerous
         Goods Guidelines.
     2.4 For traceability, each facility must have a system for recording and tracking
         referred out specimens.

3.0 Materials
     Completed appropriate requisition(s)
     Appropriate specimen(s)
     Appropriate shipping container(s)
     Completed shipping documentation, as applicable
     Donor unit segments (at least 2), as applicable

4.0 Procedure
     4.1 Determine priority.
     4.2 Determine method of transport, e.g., bus, family, air flight or courier, etc.
         and estimated time of arrival.
     4.3 Phone STAT requests to CBS or the BTS.
     4.4 For CBS requests, fax (CM 077) Fax Notification form, if applicable.
     4.5 Make a final check to ensure completed requisition and matching labelled
         specimen(s) are ready to ship.
     4.6 Complete specimen referral log.
     4.7 File the facility collection record.
     4.8 Package the specimen(s) and request form in appropriate container(s).
     4.9 Ship package(s) according to urgency.

5.0 Reporting
     N/A


Module	2	(Non-Crossmatch)	•	MP.017
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
6.0 Procedural Notes
        6.1 In crossmatch facilities that would not routinely refer out specimens, the ward
            and physician/authorized practitioner must be notified of any delay.



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)




                                                                             Module	2	(Non-Crossmatch)		•	MP.017
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                        MP.018		
                 Emergency Issue of Donor Red Cell Units


1.0 Principle
      To issue Group O unmatched donor red cell units in an emergency when time does
      not permit a type and screen/crossmatch.

2.0 Scope and Related Policies
      2.1 At minimum, Group O Rh positive should always be available for emergency use
          in all facilities where obstetrical care/dialysis is provided.
          2.1.1 The emergency unit(s) are stored in a separate clearly labelled box or area
                in the controlled blood bank refrigerator.
      2.2 A pre-transfusion blood specimen shall be drawn prior to the transfusion of
          unmatched Group O red cells whenever possible.
      2.3 Units must have a conspicuous label which clearly indicates that compatibility
          testing has not been completed.
      2.4 Emergency issue of unmatched Group O red cells will be given priority.
      2.5 Transfusion records must include a signed declaration by the requesting physician/
          authorized practitioner confirming that the clinical situation was sufficiently urgent
          to justify releasing blood products before completion of pre-transfusion testing.
      2.6 Should a red cell unit(s) be issued before compatibility testing is complete, and
          subsequently prove incompatible, the attending physician/authorized practitioner
          and the BTS Medical Director or designate shall be informed immediately.
          Transfusion of incompatible unit(s) shall be stopped immediately and transfusion
          of the unit(s) discontinued, pending the decision of the physician/authorized
          practitioner.

3.0 Materials
      Group O Rh positive or Rh negative donor red cell units
      Request form for crossmatch
      Patient specimen
      Tags (CM 106 or appropriate facility form)

4.0 Procedure
      4.1 Collect a specimen from the patient and send STAT to BTS laboratory.
          • It is preferable to collect the specimen prior to transfusion of the
            emergency blood.




Module	2	(Non-Crossmatch)		•	MP.018
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
      4.2 Select appropriate emergency red cell units.
          4.2.1 When both Group O Rh positive and Group O Rh negative units are
                available select:
                • Group O Rh negative if the intended recipient is female less than or equal
                  to 45 years of age or a male less than or equal to 18 years of age.
                • Group O Rh positive if the intended recipient is female greater than
                  45 years of age or male greater than 18 years of age.
          4.2.2 When only Group O Rh positive units are available:
                • Notify the BTS.
                • The BTS will notify the BTS Medical Director or designate within 24 hours
                  if the recipient is determined to be Rh negative and is a female less than
                  or equal to 45 years of age, or a male less than or equal to 18 years of age.
                • Administration of Rh immune globulin will be determined by the
                  BTS Medical Director after consultation with the attending physician/
                  authorized practitioner. This consultation shall be documented by the BTS
                  Medical Director.
      4.3 Record the patient information on the tag, if available.
      4.4 Remove at least 2 segments from the unit(s) prior to issue for post-transfusion
          crossmatch.
          • Affix bar code label from the red cell unit to the segments.
          • Bag and store in controlled storage refrigerator.
      4.5 Issue the red cell units following the routine protocol.
      4.6 Complete the blood product Issue/Transfusion Record (lab log) with as much
          information as is available or becomes known.
      4.7 Send the following to the BTS as soon as possible:
          • pre-transfusion blood specimen;
          • completed request form;
          • 2 donor segments; and
          • A completed Blood Services copy of the tag from each unmatched donor unit
            transfused, where applicable.
      4.8 Complete the crossmatch as soon as possible (applicable to BTS only).
      4.9 Order replacement stock as soon as possible.
      4.10 File the Blood Bank copy of the tag.

5.0 Reporting
      N/A




                                                                     Module	2	(Non-Crossmatch)		•	MP.018
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                       Version 2 • June 2007
6.0 Procedural Notes
       6.1 Use group specific crossmatch compatible red cells when the patient’s ABO has
           been determined.




   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	   											__________________________________	        __________________________________
   	       	       	        												(Senior	Management)	     	       	       		(Senior	Management)
   	       	       	        	         	       	        	
   Facility	effective	date:			__________________________________
   	       	       	        									(Date	of	implementation)




Module	2	(Non-Crossmatch)		•	MP.018
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                       MP.020		
     Transfusion Reaction Investigation (Non-Crossmatch)


1.0 Principle
      To investigate, document and report transfusion reactions to all blood, blood
      components or derivatives.

2.0 Scope and Related Policies
      2.1 The blood bank shall have processes and procedures for the detection,
          evaluation, and reporting of all suspected transfusion related adverse events.
          • If the blood bank is not staffed (e.g. outside normal working hours) then
            policies and procedures must be documented and in place to ensure that the
            requirements described in 4.2 and 4.2.1 are met.
      2.2 All transfusion reaction investigations are to be considered STAT.
      2.3 The transfusion reaction investigation shall be brought to the attention of the
          BTS Medical Director immediately, according to procedure 4.3.
      2.4 All reactions (other than rash or urticaria) shall result in immediate cancellation
          of all indate crossmatched blood and/or type and screen specimens.
      2.5 The Adverse Event Reporting System (AERS) is a required component of these
          investigations by both nursing and blood bank laboratories.
      2.6 Nursing responsibility (refer to Manitoba Transfusion Medicine Best Practice
          Resource Manual for Nursing)

3.0 Materials
      Specimens:
      Post-transfusion specimens:
         • Adults: 10-12 mL in EDTA tubes (correctly identified and labelled).
         • Pediatric: 3 mL in EDTA tube (correctly identified and labelled).
         • Urine- post-transfusion reaction (where applicable)
      Donor Unit Segments
      Transfusion Reaction Investigation Form (CM105).
      Urinalysis requisition (where applicable)
      0.9% saline and IV infusion set
      Implicated blood, blood component and/or derivative and administration set

4.0 Procedure
      If symptoms are rash and urticaria:
      • No post-transfusion specimen collection is required.
      • Ensure completion of Transfusion Investigation Reaction Form (CM105) refer
        to ‘Reporting’.

Module	2	(Non-Crossmatch)		•	MP.020
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 8
      For all other reactions or progressed symptoms of rash and/or urticaria:
      4.1 Ensure a post-transfusion specimen is collected.
      4.2 Perform a clerical check by re-checking patient and product information on the
          discontinued blood, blood component bag and/or derivative vial, product chart
          copy (tag) and any other units already infused (if available).
          4.2.1 If a clerical error is discovered:
                • Notify the blood bank Charge Technologist and the BTS Charge
                  Technologist and the BTS Medical Director
                • Initiate a search of appropriate records to determine whether
                  misidentification or incorrect issue of components has put other patients
                  at risk.
      4.3 Notify the BTS Medical Director immediately when:
          • the patient has died
          • the reaction is suspected to be severe
          • the reaction is suspected to be hemolytic
          • the reaction is suspected to be TRALI
          • the reaction is suspected to be allergic and is more than just hives, e.g. asthma,
            bronchospasm, shock and hypotension
          • any of the symptoms listed below are described on the requisition:
            - pronounced blood pressure drop
            - back pain
            - respiratory distress
            - wheezing
            - anaphylaxis
            - shock
            - hemoglobinuria
      4.4 Send post transfusion specimen, implicated retained donor unit segments and
          completed Transfusion Reaction Investigation Form (CM105) to the BTS STAT.
          • If additional donor units are required, the post transfusion reaction specimen
            can be used for the new crossmatch order. Complete and send a Request for
            Blood Components (XM101 or applicable form).
          • Retain the implicated donor unit and attached infusion set and solutions
            in the local blood bank for 7 days.
      4.5 If the reaction is febrile with a temperature increase greater than 2oC, suspect
          bacterial sepsis:
          • perform bacterial cultures on patient
          • perform bacterial cultures on donor units (do not use segments)




                                                                  Module	2	(Non-Crossmatch)		•	MP.020
2 of 8 • Manitoba Transfusion Quality Manual for Blood Banks                    Version 2 • June 2007
5.0 Reporting
      For Reactions to all Blood, Blood Components and Derivatives
      5.1 Review the CM105 form and ensure it is complete.
      5.2 Retain the following copies:
          • “Chart copy” to be filed according to facility policies and procedures.
          • Pink “Blood Bank” copy to be retained indefinitely in the Blood Bank
            department.
      5.3 Send green “Manitoba Health” copy and white “Blood Services” copy to the BTS
          that performed the crossmatch.
      5.4 For reactions to derivatives forward the green “Manitoba Health” copy
          and the white “Blood Services” copy to the BTS that performs your facility’s
          crossmatching.
      5.5 After the transfusion reaction investigation is completed a signed report will be
          received from the BTS.
          Ensure that:
          • a report is placed on the patient’s chart
          • a copy is retained indefinitely in the Blood Bank department.

6.0 Procedural Notes
      6.1 See table for reactions




Module	2	(Non-Crossmatch)		•	MP.020
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 3 of 8
* Technical Resource Manual (TraQ). British Columbia Provincial Blood Coordinating Office. April 2000.




    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)




                                                                             Module	2	(Non-Crossmatch)		•	MP.020
4 of 8 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
Nursing Process
Manitoba	Adverse	Transfusion	Reaction	Reporting	System

                                                  Transfusion
                                                    Reaction

1
        Nursing/Health Care Professional notifies Attending Physician/*Authorized Practitioner
        immediately! Refer to the ‘Transfusion Reactions Algorithm’
        & facility policies and procedures


2
       Is this a serious reaction? A serious reaction…
       1. Requires medical intervention directly attributable to the event; or
       2. Results in persistent or significant disability or incapacity; or
       3. Necessitates medical intervention to preclude permanent damage
           or impairment of a body function; or
       4. Is life threatening or results in death.
       If this is NOT a serious reaction go directly to box 5 below.



3
        Attending Physician/*Authorized Practitioner notifies BTS Medical
        Director immediately!


4       BTS Medical Director notifies CBS Medical Director (Winnipeg) immediately!              CBS Medical Director
                                                                                                notifies Health Canada

5
       Nursing/Health Care Professional:
       • completes “Transfusion Reaction Investigation Form” CM105 and forwards to Blood Bank.


6
       Blood Bank (or Blood Transfusion Service (BTS) acting as the Blood Bank):
       Will follow Processes A, B, or C depending on the facilities and the type of product
       implicated in the transfusion reaction.


*Authorized Practitioner defined in Manitoba Transfusion Medicine Best Practice Resource Manual for Nursing




Module	2	(Non-Crossmatch)		•	MP.020
Version 2 • June 2007                                    Manitoba Transfusion Quality Manual for Blood Banks •  of 8
Process A
Manitoba	Adverse	Transfusion	Reaction	Reporting	System
Where CBS is the Blood
Transfusion Service                               Transfusion
(Crossmatch Laboratory)                             Reaction

 1       Nursing/Health Care Professional notifies Attending Physician/*Authorized Practitioner
       immediately! Refer to the ‘Transfusion Reactions Algorithm’ and facility policies and procedures


 2      Is this a serious reaction? A serious reaction…
        1. Requires medical intervention directly attributable to the event; or
        2. Results in persistent or significant disability or incapacity; or
        3. Necessitates medical intervention to preclude permanent damage
            or impairment of a body function; or
        4. Is life threatening or results in death.
        If this is NOT a serious reaction go directly to box 5 below.



 3      Attending Physician/*Authorized Practitioner notifies BTS Medical Director immediately!

 4                                                                                               CBS Medical Director
        BTS Medical Director notifies CBS Medical Director (Winnipeg) immediately!
                                                                                                 notifies Health Canada

 5
        Nursing/Health Care Professional:
        • completes “Transfusion Reaction Investigation Form” CM105 and forwards to Blood Bank.


 6
        Blood Bank (or Blood Transfusion Service (BTS) acting
        as the Blood Bank):
                                                                                                Patient’s chart
        • verifies and completes CM105 and forwards to BTS for
         investigation and retains CM105 “Pink” copy
        • Retains a copy of conclusions and sends a copy to patient’s chart
                                                                                                Public Health
                                                                                                Agency of Canada
 7      CBS Winnipeg (acting as the BTS):                                                       (PHAC)
        • performs investigation
        • sends CM105 “Green” copy to MB Health
        • CBS\BTS Medical Director completes conclusions                                                Legend
        • sends conclusions to facility Blood Bank and MB Health

 8      MB Health (Provincial Blood Programs
                                                                                                       Investigation

        Coordinating Office):
        • enters and analyses data                                                                      Conclusions
        • sends anonymized subset to PHAC quarterly

*Authorized Practitioner defined in Manitoba Transfusion Medicine Best Practice Resource Manual for Nursing

                                                                                   Module	2	(Non-Crossmatch)		•	MP.020
 of 8 • Manitoba Transfusion Quality Manual for Blood Banks                                     Version 2 • June 2007
Process B
Manitoba	Adverse	Transfusion	Reaction	Reporting	System
Where a DSM Blood
Transfusion Service is the
                                                 Transfusion
Crossmatch Laboratory                              Reaction

1
        Nursing/Health Care Professional notifies Attending Physician/*Authorized Practitioner immediately!
        Refer to the ‘Transfusion Reactions Algorithm’ and facility policies and procedures


2
       Is this a serious reaction? A serious reaction…
       1. Requires medical intervention directly attributable to the event; or
       2. Results in persistent or significant disability or incapacity; or
       3. Necessitates medical intervention to preclude permanent damage
           or impairment of a body function; or
       4. Is life threatening or results in death.
       If this is NOT a serious reaction go directly to box 5 below.



3
        Attending Physician/*Authorized Practitioner notifies BTS Medical Director immediately!

4                                                                                                CBS Medical Director
        BTS Medical Director notifies CBS Medical Director (Winnipeg) immediately!               notifies Health Canada

5      Nursing/Health Care Professional:
       • completes “Transfusion Reaction Investigation Form” CM105 and forwards to Blood Bank.


6      Blood Bank (or Blood Transfusion Service (BTS)                                              Patient’s chart
       acting as the Blood Bank):
       • verifies and completes CM105 and forwards to BTS
       for investigation and retains CM105 “Pink” copy
       • Retains a copy of conclusions and sends a copy to patient’s chart                              Legend

7      DSM BTS:
                                                                                                       Investigation
       • performs investigation
       • sends CM105 “Green” and “White” pages to MB Health                                            Conclusions
       (retain a photocopy of both sides of the ‘White’)
       • Retains a copy of conclusions and sends copy to reporting
       facility Blood Bank or to patient’s chart as applicable
                                                                                             9
                                                                                                 DSM Medical
8      MB Health (Provincial Blood Programs
                                                                                                 Director: completes
                                                                                                 conclusions & returns
       Coordinating Office):                                                                     to MB Health
       • forwards CM105 to DSM Medical Director
       • returns conclusions to BTS with DSM Medical Director’s conclusions
       • enters and analyses data                                                              Public Health Agency
       • sends anonymized subset to PHAC quarterly                                             of Canada (PHAC)

*Authorized Practitioner defined in Manitoba Transfusion Medicine Best Practice Resource Manual for Nursing

Module	2	(Non-Crossmatch)		•	MP.020
Version 2 • June 2007                                    Manitoba Transfusion Quality Manual for Blood Banks •  of 8
Process C
Manitoba	Adverse	Transfusion	Reaction	Reporting	System
For Derivatives                                   Transfusion
                                                    Reaction
1
        Nursing/Health Care Professional notifies Attending Physician/*Authorized Practitioner immediately!
        Refer to the ‘Transfusion Reactions Algorithm’ and facility policies and procedures

 2
        Is this a serious reaction? A serious reaction…
        1. Requires medical intervention directly attributable to the event; or
        2. Results in persistent or significant disability or incapacity; or
        3. Necessitates medical intervention to preclude permanent damage
            or impairment of a body function; or
        4. Is life threatening or results in death.
        If this is NOT a serious reaction go directly to box 5 below.

 3      Attending Physician/*Authorized Practitioner notifies BTS Medical Director immediately!


 4      BTS Medical Director notifies CBS Medical Director (Winnipeg) immediately!


 5      Nursing/Health Care Professional:
        • completes “Transfusion Reaction Investigation Form” CM105 and forwards to Blood Bank.


 6      Blood Bank (or Blood Transfusion Service (BTS)                                           Patient’s chart
        acting as the Blood Bank):
        • verifies and completes CM105 and forwards to BTS
          for investigation and retains CM105 “Pink” copy
        • Retains a copy of conclusions and sends a copy to patient’s chart                                     Legend

 7                                      8                                                                      Investigation
       BTS: forwards CM105                   CBS Crossmatch Lab:
                                                                                                               Conclusions
       “Green” and back                      forwards CM105 “Green”
       “White” pages to CBS                  and back “White” pages                                           Manufacturer’s
       Crossmatch Lab                        to CBS Medical Director.                                          Conclusions


                                                                                             Attending Physician
 9     CBS Medical Director:
       • notifies Manufacturer and CBS Head Office
       • completes back of CM105
       • sends CM105 “Green” page and copy of conclusions to MB Health                         CBS Head Office
       • sends CM105 conclusions to reporting Blood Bank
         or BTS as applicable
       • sends manufacturer’s conclusions to Attending Physician                             Manufacturer
         and to reporting Blood Bank or BTS as applicable                                    Investigation and Results



     Public Health Agency         10    MB Health
                                        • enters and analyses data                              Health Canada
      of Canada (PHAC)                  • sends anonymized subset to PHAC quarterly

*Authorized Practitioner defined in Manitoba Transfusion Medicine Best Practice Resource Manual for Nursing
                                                                                    Module	2	(Non-Crossmatch)		•	MP.020
8 of 8 • Manitoba Transfusion Quality Manual for Blood Banks                                      Version 2 • June 2007
                       Module 2: CrossMatCh
Module 2: Crossmatch
          Module	2:	Pre-Transfusion	Testing	(Crossmatch)
                        Table of Contents
    Patient Identification and Specimen Procurement ..........................................MP.001
    Specimen Acceptance/Rejection and Suitability ..............................................MP.002
    Patient History Files .............................................................................................MP.003
    Specimen Centrifugation ......................................................................................MP.004
    Labelling Tubes/ Gel Cards and Block Set Up ...................................................MP.005
    Preparing Red Cell Suspensions .........................................................................MP.006
    Reading and Recording Hemagglutination Reactions: Tube and Gel ............MP.007
    ABO Testing .............................................................................................................MP.008
    Rh Testing ................................................................................................................MP.009
    Cell Washing for Antiglobulin: Automated and Manual ..................................MP.010
    Indirect Antiglobulin Test ....................................................................................MP.011
    Indirect Antiglobulin Test- Gel Method ...........................................................MP.011A
    Indirect Antiglobulin Test- Saline Method ...................................................... MP.011B
    Indirect Antiglobulin Test- PEG Method ......................................................... MP.011C
    Antibody Screen Reporting ...................................................................................MP.012
    Immediate Spin Crossmatch ...............................................................................MP.013
    Determining Compatibility of Donor Red Cell Units ........................................MP.014
    Pre-Transfusion Testing Requirements for Neonates
    (Small Volume Red Cell Transfusion) .................................................................MP.015
    Handling Outdated Type and Screens/ Patient Assigned Units ......................MP.016
    Specimen Referral ..................................................................................................MP.017
    Emergency Issue of Donor Red Cells Units ......................................................MP.018
    Issuing Donor Red Cells Prior to Completion of Pre-Transfusion Testing...MP.019
    Transfusion Reaction Investigation (Crossmatch) ...........................................MP.020




Module	2	(Crossmatch)	•Table	of	Contents
Version 2 • June 2007                                          Manitoba Transfusion Quality Manual for Blood Banks
                                       MP.001		
         Patient Identification and Specimen Procurement


1.0 Principle
To positively identify a patient, and accurately label specimens that are used for
pre-transfusion testing.
NOTE: Most hemolytic transfusion reactions result from errors in patient or specimen
identification, therefore the transfusion service shall accept only specimens with
complete, accurate and legible labels.

2.0 Scope and Related Policies
      2.1 Only authorized, trained individuals shall collect specimens.
      2.2 Request forms for specimen collection and/or blood components, and any other
          documentation accompanying blood specimens from the patient, shall contain
          sufficient information to allow for positive identification of the intended patient.
      2.3 There shall be unequivocal identification of the intended patient before drawing
          blood specimens using the patient’s armband or Provincial Health Card.
          This shall include verification of:
          • The patient’s last and first name, and
          • Personal Health Identification Number (PHIN), or
          • Unique identifier, if there is no PHIN.
      2.4 Each facility must have a system for patient identification for unidentified
          patients.
      2.5 Should inaccuracies or discrepancies be discovered during the identification
          process, blood specimens shall not be collected until the matter has been
          satisfactorily resolved.
      2.6 Blood specimens shall be labelled in the patient’s presence. The label shall be
          completed with the patient’s name, PHIN (or unique identifier) and date of
          collection and attached to the specimen tube before leaving the patient’s side.
      2.7 All specimen labels and request forms must be complete, accurate and legible.
          • Changes shall not be made to patient identification on either the specimen
            label(s) or the request form once the specimen has been received in the BTS
            laboratory.
          • A new specimen shall be collected if any discrepancy exists.
      2.8 Specimen tubes must not be over-labelled when mistakes are detected on
          the original label.




Module	2	(Crossmatch)		•	MP.001
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 4
3.0 Materials
Requisition (or electronic order) showing the patient’s last and first name and unique
identifier (PHIN).
Pre-printed specimen labels (i.e. computer or addressograph) if available.
Materials for specimen collection as per facility procedure(s):
NOTE: Volumes given below are for adult patients. For neonatal and pediatric
patients, refer to facility guidelines for specimen collection procedures and volumes.
Type and Screen/Crossmatch:
• Request for Blood Components (XM101) or appropriate BTS request form
• Appropriate EDTA specimen (volume as per request form)
• A Fax notification form (CM 077) as applicable
Antibody Investigation:
• Request for Miscellaneous Testing (XM 104) or appropriate BTS request form
• Appropriate EDTA specimen (volume as per request form)
Transfusion Reaction Investigation:
• Transfusion Reaction Investigation Form (CM105)
• Appropriate EDTA specimen (refer to MP.020 Transfusion Reaction Investigation)
Pre and Post-Natal Testing:
• Request for Pre and Post-Natal Testing (Rh.101)
• Appropriate clotted and EDTA specimen (volume as per request form)
Cord Blood Testing:
• Request for Cord Blood Testing (Rh.105)
• Appropriate EDTA specimen (volume as per request form)
• Refer to procedural note 6.2
All other testing:
• Consult BTS or CBS Accession Laboratory for specimen amount and requisition
• Protective covering (e.g. ziplock bag) for specimens is recommended for
“in-hospital” transport.

4.0 Procedure
      4.1 Ensure a request form is prepared with the correct information.
          The request form shall include the following information:
          • Patient’s last and first name
          • A PHIN or unique identifier if there is no PHIN
          The request form should include the following information:
          • Facility name
          • Patient location
          • Facility medical record number (MRN)
          • Patient’s date of birth
          • Treatment Order
          • Name of ordering physician/authorized practitioner
          • Intended date and time of transfusion/infusion
          • Diagnosis and reason for transfusion/infusion
                                                                   Module	2	(Crossmatch)		•	MP.001
2 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                 Version 2 • June 2007
          • Priority
          • Special handling requirements
          • Transfusion/infusion history
      4.2 Confirm that there is a patient identification band physically attached to the
          patient (i.e. not to the bed, wall or the door).
          • If the patient is an inpatient or is admitted to emergency and does not have an
            identification band, have nursing positively identify patient according to facility
            policy, ensure that an identification band is prepared and the band is attached
            to the patient prior to collection.
            NO BAND – NO BLOOD
            NOTE: If the patient’s clinical condition prohibits physical placement of an
            identification band on the patient, the patient must be positively identified
            by their primary caregiver.
            • If the patient is an outpatient ensure positive identification of patient using
              a Manitoba Health Card (PHIN) or unique identifier.
      4.3 Before collecting the specimen, ask the patient to spell his/her last and first name
          and give date of birth (Do not say, “Are you…?”). As the patient is spelling their
          name and date of birth, compare letter by letter and number by number to the
          corresponding information on the requisition.
          If the patient is unable to communicate his/her name, ask a qualified person,
          e.g. the patient’s nurse, to identify the patient and sign the requisition before
          collecting the specimen(s).
      4.4 Compare the patient’s last and first name and PHIN or unique identifier on the
          request form and patient identification band. They must be identical.
          • Any discrepancy must be resolved by the ward or Health Records before
            performing the venipuncture.
      4.5 Perform specimen collection as per established facility procedure(s) following
          routine practices for infection control.
      4.6 Label the specimen immediately after performing the venipuncture, before
          leaving the patient’s side.
          • Indelible ink must be used for handwritten labels
          4.6.1 The specimen label must include:
                • Patient’s last and first name
                • PHIN or unique identifier
                • Date and time of collection
                • Facility name, if applicable
                • Initials of the phlebotomist
          4.6.2 Complete the requisition with:
                • Phlebotomist’s printed name, initials and classification
                • Date and time of collection
                • Facility name where specimen is drawn
                • Facility name where blood, blood component and derivative is to be sent

Module	2	(Crossmatch)		•	MP.001
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 3 of 4
        4.7 Perform a final check before leaving the patient’s side. Confirm that the patient’s
            last and first name and PHIN or unique identifier are identical on:
            • Specimen tube label(s)
            • Request form
            • Patient identification band
           Corrections may only be made to the specimen tube label at this time:
           • Put a single line through the error
           • Make the correction
           • Initial the change
5.0 Reporting
        N/A

6.0 Procedural Notes
        6.1 If unsure of required specimen volume, contact BTS or CBS for direction.
        6.2 When sending cord blood specimen, ensure maternal specimen and requisition
            is sent.



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	         	     	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	     	       	        	        	        	
    Facility	effective	date:			__________________________________
    	         	     	       									(Date	of	implementation)




                                                                                 Module	2	(Crossmatch)		•	MP.001
4 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                          MP.002		
           Specimen Acceptance/Rejection and Suitability


1.0 Principle
      To describe the criteria for the acceptance/rejection and suitability of specimens used
      for pre-transfusion/testing.

2.0 Scope and Related Policies
      2.1 Only complete, accurate and legibly labelled specimens and requisitions received
          in the blood bank/BTS shall be accepted for pre-transfusion/testing.
      2.2 Suitability of specimen(s) will be determined according to established criteria.

3.0 Materials
      Request form
      Specimen(s)

4.0 Procedure
      4.1 Compare the label(s) on the specimen(s) and the corresponding request form
          to ensure the following information is identical:
          4.1.1 Patient’s last and first name
          4.1.2 Patient’s PHIN or unique identifier
                • No corrections can be made to the specimen label.
                • Collect a new specimen if any of the above information is missing
                  or incorrect.
                • Complete an occurrence report according to facility procedure(s) and
                  submit it to a supervisor.
          4.1.3 Date/time of collection
                • No corrections can be made to the specimen label.
                  Obtain information from the phlebotomist, if missing, and document
                  on the specimen label and request form.
          4.1.4 Name of the phlebotomist
                • The phlebotomist must print their full name and initials on the request
                  form. Initials on specimen label are preferred but not mandatory.
                • Collect a new specimen if the phlebotomist is not available to complete
                  the request form.




Module	2	(Crossmatch)		•	MP.002
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
      4.2 Check all pages of the request form for accuracy and legibility of the following
          information:
                • Patient’s date of birth
                • Facility name
                • Patient location
                • Test and product order
                • Intended date of transfusion/infusion
                • Ordering physician/authorized practitioner
                • Diagnosis and/or reason for transfusion/infusion
                • Priority
                • Transfusion/infusion history, if applicable
          4.2.1 Obtain any missing information.
          4.2.2 Obtain a new requisition if the addressograph on page one is not identical
                to the addressograph on page two.
      4.3 Assess the age of the specimen.
          4.3.1 Confirm the date of collection and the intended date of transfusion/infusion
                are within the acceptable time period.
                • Arrange to have another specimen collected, if unsuitable.
          4.3.2 The specimen must be collected from the patient within 3 days prior to a
                scheduled transfusion.
                • Day “0” is the date of collection.
                Example: For a 3 day outdate, a specimen collected on April 10 may be used
                for pre-transfusion testing up to midnight on April 13.
          4.3.3 Pre-Admission Clinic (PAC) specimens can be collected up to 21 days prior to
                scheduled operating room (OR) date, unless the patient:
                • Has been transfused with a blood component containing red cells within
                  the previous 3 months.
                • Has been pregnant within the previous 3 months.
                • Patient history is questionable or unavailable.
                  NOTE: ‘PAC specimens’ day “0” is the date of the surgery.
                • Eligibility for PAC is determined by the screening nurse or physician/
                  authorized practitioner.
      4.4 Specimens for type and screen and crossmatch will outdate at midnight, 3 days
          from the date of collection.
          4.4.1 If red cells are required after 3 days, a new specimen must be collected and
                a type and screen performed on the new specimen.
          4.4.2 If red cells are required urgently before a new specimen is collected or
                before a type and screen can be completed, red cells must be issued as
                unmatched and the BTS must be notified.




                                                                      Module	2	(Crossmatch)		•	MP.002
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                    Version 2 • June 2007
       4.5 In some rural facilities, a 7 day outdate may be applied as determined by
           the Canadian Blood Services Crossmatch Laboratory (or 3 days following the
           transfusion of the first unit).
       4.6 Reject specimens for the following additional reasons:
          • Specimen is grossly hemolyzed.
          • Specimen appears contaminated with IV fluid.
          • Specimen is grossly contaminated with blood on the outside.
          • Specimen has not been collected in a lavender top EDTA tube.
          • Letters or numbers are overwritten rendering them illegible.
          • There is an error(s) in the collection date on the specimen tube.
          • Specimen is over-labelled and the information on the label underneath does
            not clearly identify that the specimen was collected from the same patient.
                 • For example, “Smith, Bill Initials “ on the label underneath and “Smith,
                   William” written on the upper label is acceptable.
                 • “Smith Initials, Marie” on the label underneath and “Jones, Marie” on the
                   upper label is not acceptable.
          • Specimen information has been corrected and the correct information does not
            clearly identify that the specimen was collected from the same patient.
                 • e.g.,” Smith Initials, Marie” on the label that has been corrected to “Jones,
                   Marie” is not acceptable.
                 • Name on the requisition has a first initial and middle name, e.g.,“R. John”
                   and the specimen is labelled with the middle name only, e.g., “John” is
                   not acceptable.
          • Specimen label has been altered using “white out”.
          • Specimen is not labelled with indelible ink.
       4.7 Specimens should be stored at 1°C to 8°C.

5.0 Reporting
       N/A

6.0 Procedural Notes
       N/A


   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	      											__________________________________	     __________________________________
   	         	        	       												(Senior	Management)	    	      	       		(Senior	Management)
   	         	        	       	            	       	      	
   Facility	effective	date:			__________________________________
   	         	        	       									(Date	of	implementation)


Module	2	(Crossmatch)		•	MP.002
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                           MP.003		
                                  Patient History Files


1.0 Principle
      1.1 To review previous patient records and document special instructions/comments
          to assist in the selection of appropriate blood, blood components and derivatives
          for transfusion/infusion.
      1.2 To prepare a historical summary card (and antibody/special instruction card if
          necessary) when previous patient records are not found or the patient has special
          transfusion/infusion requirements.

2.0 Scope and Related Policies
      2.1 When a patient specimen is received, a history check shall be done. This history
          check shall be documented.
      2.2 Interpretations of current test results shall be compared with previous patient
          history file(s).
      2.3 Previous admission records and/or previous patient history files alone shall not
          be used to determine the patient’s ABO and Rh type for the purpose of red cell
          transfusions.
      2.4 Records of transfusion/infusion, and of any complications arising, antibody
          reports and information required for lookback/traceback purposes shall be
          kept indefinitely.

3.0 Materials
      BTS patient history files
      Request form

4.0 Procedure
      4.1 Check for previous patient history by searching card files by patient name.
      4.2 If a historical file is found:
          • Verify all patient information with the request form. If there is a discrepancy,
            it must be resolved (resolution may involve verifying information with the
            patient, the patient’s family, medical records or reviewing previous patient
            history file(s)).
          • Once current tests are completed, review and compare the following with
            previous patient history files:
              • ABO and Rh type
              • Complications in determining blood type
              • Clinically significant antibodies
              • Severe adverse reactions to a previous transfusion/infusion

Module	2	(Crossmatch)		•	MP.003
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
           The comparison shall be documented.
        4.3 Record the following pertinent patient information on the request form:
           • Antibody(ies)
           • Special transfusion/infusion requirements
        4.4 If a historical file is not found, write “NF” (no file) in the appropriate area on the
            request form. Create a new patient history summary card.
           • Print the last name, first name and middle initial. (If the last name is a common
             name e.g. Smith or Jones, then include the middle name).
           • Date of birth, if available (dd/mmm/yyyy)
           • Medical Record Number/Chart number
           • Personal Health Identification Number (PHIN)
           • Special transfusion/infusion requirements or instructions (e.g. irradiated,
             antibodies, donor red cell antigen requirements, washed, etc.)
           • ABO and Rh
           • Transfusion and reaction history
        4.5 Document the history check by initialing the appropriate area on the request
            form.
        4.6 Attach the history summary card behind the request form.
        4.7 Update the history summary card prior to filing card. Refer to procedural notes
            for computerized patient history files.

5.0 Reporting
        N/A

6.0 Procedural Notes
        6.1 If patient history files are computerized:
           6.1.1. Follow steps 4.1 to 4.4 as above with the exception of performing the file
                  search by the PHIN instead of the name.
           6.1.2. Update the electronic file when the testing and/or transfusion has been
                  completed.
           6.1.3. If there are any special instructions, i.e., reaction or antibodies complete a
                  paper patient history file as well as an electronic file.


    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	         	     	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	     	       	        	        	        	
    Facility	effective	date:			__________________________________
    	         	     	       									(Date	of	implementation)


                                                                                 Module	2	(Crossmatch)		•	MP.003
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                                  MP.004		
                                  Specimen Centrifugation


1.0 Principle
       1.1 To separate a whole blood specimen into plasma and red cells.
       1.2 To observe the plasma for suitability for testing.

2.0 Scope and Related Policies
       The specimens shall be centrifuged to ensure adequate separation of red cells and
       plasma.

3.0 Materials
       Centrifuge
       Specimens (EDTA)

4.0 Procedure
       4.1 Centrifuge the patient specimen tube(s) for 5-10 minutes at 3,000 – 3,500 rpm.
       4.2 After centrifugation, remove the specimen tube(s) from the centrifuge.
       4.3 Visually check specimen for suitability for testing. Reject if grossly hemolyzed.

5.0 Reporting
       N/A

6.0 Procedural Notes
       N/A



   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	         	      	       												(Senior	Management)	     	       	       		(Senior	Management)
   	         	      	       	        	        	        	
   Facility	effective	date:			__________________________________
   	         	      	       									(Date	of	implementation)




Module	2	(Crossmatch)		•	MP.004
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 1 of 1
                                        MP.005		
               Labelling Tubes/Gel Cards and Block Set up


1.0 Principle
      To label tubes/gel cards and set up serologic tests in a consistent manner to ensure
      positive identification of test results.

2.0 Scope and Related Policies
      2.1 All tubes and/or gel cards for pre-transfusion testing shall be labelled in a
          consistent manner, e.g., using the same abbreviation, minimum number of letters
          for patient names, etc., and arranged in the same order in the work block.
      2.2 It is unacceptable practice to use unlabelled or outdated tubes for testing.

3.0 Materials
      Tubes
      ID Micro-Typing System ™ Anti-IgG cards
      Water resistant marker
      Work block

4.0 Procedure
      4.1 Labelling Tubes
          4.1.1 Label tubes as described in Table 1.
                • Label all tubes with the patient name, unique identifier and corresponding
                  reagent.
                • Label the tubes from top to bottom as illustrated.

                   AC
                   R1212
 Top of tube                                                         Bottom of tube




Module	2	(Crossmatch)		•	MP.005
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 
Table 1: Labelling Tubes

  Test                                                Tube Label

  Patient’s cell suspension                           Patient’s last name and unique
                                                      identifier (ID)

  Anti-A                                              Patient unique ID A

  Anti-B                                              Patient unique ID B

  A1 Cells                                            Patient unique ID AC

  B Cells                                             Patient unique ID BC

  Anti-D                                              Patient unique ID DI

  Anti-D                                              Patient unique ID DII

  Auto Control                                        Patient unique ID Rh C

  The following tests if required:

  Antibody Screen Cell 1                              Patient unique ID SI

  Antibody Screen Cell 2                              Patient unique ID SII

  Antibody Screen Cell 3*                             Patient unique ID SIII (if applicable)

  Donor unit cell suspension                          Donor unique ID

*Some facilities may only use a 2 cell screen.




                                                                              Module	2	(Crossmatch)		•	MP.005
2 of  • Manitoba Transfusion Quality Manual for Blood Banks                            Version 2 • June 2007
Place the tubes in the work block as illustrated in Table 2.
Table 2: Block Set-Up for Tubes Only (1 block per patient)

  ABO/Rh Testing

  Patient               Patient      Patient
  Specimen              Specimen     3% cell
                                     suspension

  ABO Grouping          Anti-A       Anti-B                            A1 cells         B cells



  Rh Typing             Anti-D       Anti-D                            Rh Control




  Antibody Screen/Crossmatch (Tube Method)

  Antibody                                                                              SI*
  Screen
  Tube Test

                                                                                        SII*




                                                                                        SIII*
                                                                                        (if applicable)


  Donor Unit            Donor Unit                                                      IS/IAT*
  Crossmatch            3% cell                                                         Crossmatch
  Tube Test             suspension

                        Donor Unit                                                      IS/IAT*
                        3% cell                                                         Crossmatch
                        suspension

                        Donor Unit                                                      IS/IAT*
                        3% cell                                                         Crossmatch
                        suspension

*An extra rack may be used for 37°C incubation

Module	2	(Crossmatch)		•	MP.005
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 3 of 
      4.2 Labelling Gel Cards
          4.2.1 Label the appropriate new or partially used MTSTM Anti-IgG card(s).
                • Each red cell suspension tested requires one microtube.
                • Write the patient’s “unique identifier” in the area of the label (as shown
                  below) on the MTSTM Anti-IgG card.
                • A pre-printed label may be used (ensure the information is identical to the
                  information on the specimen label).
                • If the card is partially used, cross out the patient or donor unit identifier
                  on the used portion.
          For Antibody Screen:
                • Label each microtube with the screen cell number.
                • If performing a 2 cell screen, 3 patient specimens may be tested on the
                  same card.


            Patient #1                             Patient #2                         Patient #3
             Unique                                 Unique                             Unique
            Identifier                             Identifier                         Identifier
 SI               SII                 SI                 SII             SI                 SII
                • If performing a 3 cell screen, 2 patient specimens may be tested on the
                  same card.


                                 Patient #1                         Patient #2
                                   Unique                             Unique
                                 Identifier                         Identifier
                     SI           SII       SIII           SI        SII       SIII
          For Crossmatch:
                • Label one microtube per each donor unit required with the last 4 digits
                  of the donor unit.


                                 Patient #1                         Patient #2
                                  Unique                             Unique
                                 Identifier                         Identifier
                     Unit #       Unit #    Unit #         Unit #    Unit #    Unit #

          4.2.2 Place the gel card in a specially designed work block (or in gel card holder).




                                                                              Module	2	(Crossmatch)		•	MP.005
4 of  • Manitoba Transfusion Quality Manual for Blood Banks                            Version 2 • June 2007
5.0 Reporting
       N/A

6.0 Procedural Notes
       N/A



   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	         	      	       												(Senior	Management)	     	       	       		(Senior	Management)
   	         	      	       	        	        	        	
   Facility	effective	date:			__________________________________
   	         	      	       									(Date	of	implementation)




Module	2	(Crossmatch)		•	MP.005
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks •  of 
                                        MP.006		
                          Preparing Red Cell Suspensions


1.0 Principle
      To prepare correctly a red cell suspension.

2.0 Scope and Related Policies
      Cell suspensions (3% and 0.8%) shall be prepared in order to ensure optimal
      antigen/antibody ratio.
      • Correctly prepared cell suspensions are important to the integrity of the test.
      • Incorrectly prepared cell suspensions may cause a false negative test result.

3.0 Materials
      Serologic centrifuge
      Work block(s)
      MTSTM Pipettor
      Tubes (10mm x 75mm, 12mm x 75mm)
      Transfer pipettes
      Segment devices (for cutting donor segments)
      Red cells (donor, patient or reagent)
      0.9% saline
      MTS Diluent 2TM

4.0 Procedure
      4.1 Preparing 3% Red Cell Suspension from packed red cells
          4.1.1 Label a tube with the appropriate information.
          4.1.2 Dispense 1 drop of packed red cells (or 2 drops of whole blood) into the
                labelled tube (refer to procedural note 6.1 to open donor segments).
          4.1.3 Add 0.5 - 1.0 mL saline to the labelled tube.
          4.1.4 Mix to re-suspend.
          4.1.5 Adjust as necessary to a 3% suspension by adding or removing saline.
                • Compare to a commercial 3% reagent red cell suspension (e.g. reverse
                  grouping cells).
      4.2 Preparing a washed 3% cell suspension
          4.2.1 Dispense 1 drop of packed red cells (or 2 drops of whole blood) into a
                labelled tube(s).




Module	2	(Crossmatch)		•	MP.006
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
          4.2.2 Fill the tube with saline leaving approximately 1 cm from the top of the tube
                empty. Direct the saline into the bottom of the tube so that the red cells are
                mixed homogeneously with the saline.
                CAUTION: Avoid contamination from one tube to the next while dispensing
                saline into several tubes.
          4.2.3 Centrifuge the tube(s). Suggested time/rpm: 45 to 60 seconds at 3,400 ± 200
                rpm (high setting on serologic centrifuge).
          4.2.4 Decant or suction the saline from the tube(s).
                If manually decanting into a sink or biohazard container, follow established
                safety procedures.
                Leave the red cell “button” intact as much as possible.
          4.2.5 Turn the tube(s) upright. Mix the tube(s) gently to dislodge the red
                cell “button”.
          4.2.6 Repeat steps 4.2.2 through 4.2.5 if more than one wash is required.
          4.2.7 After the last wash, add 0.5 to 1.0 mL of saline.
          4.2.8 Mix to re-suspend.
          4.2.9 Compare with a commercial 3% reagent red cell suspension.
                If the cell suspension is too heavy, add additional saline.
                If the cell suspension is too light, repeat steps 4.2.3, 4.2.4 and 4.2.7
                (but adding less saline) and then 4.2.8.
      4.3 Preparing a 0.8% Red Cell Suspension from packed red cells
          4.3.1 Label a 12mm x 75mm tube with the appropriate information.
          4.3.2 Add 1 mL of MTS Diluent 2™
          4.3.3 Add 10µL of packed red cells into the labelled tube
          4.3.4 Mix to re-suspend
      4.4 Preparing a 0.8% Red Cell Suspension from a 3% cell suspension
          4.4.1 Label a 12mm x 75mm tube with the appropriate information.
          4.4.2 Mix the 3% cell suspension thoroughly.
          4.4.3 Pipette 150μL of the 3% cell suspension to a labelled tube.
          4.4.4 Add a small amount of saline to the tube to give sufficient supernatant
                to decant.
          4.4.5 Centrifuge for one minute.
          4.4.6 Decant the supernatant.
          4.4.7 Pipette 300μL of MTS Diluent 2TM to the labelled tube. (Refer to procedural
                note 6.2).
          4.4.8 Mix to re-suspend.
          4.4.9 Compare to a commercial 0.8% reagent red cell suspension if available.
          NOTE: Other methods recommended by the manufacturer may be used to
          prepare a 0.8% cell suspension if a suitable pipette is available.
                                                                         Module	2	(Crossmatch)		•	MP.006
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                       Version 2 • June 2007
       4.5 Preparing a 3% Red Cell Suspension from 0.8% red cell suspension
          4.5.1 Label a tube with the appropriate information.
          4.5.2 Mix the 0.8% cell suspension thoroughly.
          4.5.3 Add 6 drops of the 0.8% cell suspension to a labelled tube.
          4.5.4 Centrifuge for one minute.
          4.5.5 Decant the supernatant.
          4.5.6 Add 2 drops of saline to each tube.
          4.5.7 Mix to re-suspend.
          4.5.8 Compare to a commercial 3% reagent red cell suspension.
          NOTE: Used to convert 0.8% screening cells to a 3% cell suspension

5.0 Reporting
       N/A

6.0 Procedural Notes
       6.1 Preparing red cell suspensions from donor unit segments using a segment device.
          Visually inspect the donor unit segment.
          • If a segment is clotted or hemolyzed, inspect the next segment attached to
            the donor unit bag until a segment is found that is not clotted or hemolyzed.
          • If all segments are clotted or hemolyzed, discard the donor unit. Report the
            donor unit number and bag lot number to the blood supplier.
       6.2 To prepare red cell suspension from a cord blood specimen, 3 washes are
           required.
       6.3 MTS Diluent 2™ should be visually checked each day of use to ensure it does
           not become discolored, turbid or show any signs of bacterial contamination.
          • False positive or false negative test results may occur from bacterial
            contamination of test materials.




   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	         	      	       												(Senior	Management)	     	       	       		(Senior	Management)
   	         	      	       	        	        	        	
   Facility	effective	date:			__________________________________
   	         	      	       									(Date	of	implementation)




Module	2	(Crossmatch)		•	MP.006
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                         MP.007		
Reading and Recording Hemagglutination Reactions: Tube and Gel


1.0 Principle
      To standardize reading, grading and recording of hemagglutination reactions in
      tubes and in MTSTM gel columns.

2.0 Scope and Related Policies
      2.1 There shall be a standardized procedure for reporting hemagglutination
          reactions which will contribute to uniformity and reproducibility of test results.
      2.2 Each test result shall be recorded immediately upon reading.

3.0 Materials
      Light box (optional)
      Microscope (optional)
      Illuminated concave mirror (optional)
      Tubes (containing reactions)
      MTS™ Anti-IgG cards (containing reactions)

4.0 Procedure
      4.1 Tube Reactions
          4.1.1 Remove the test tube(s) from the centrifuge without disturbing the cell button.
          4.1.2 Examine the supernatant for hemolysis and, if present, record on the request
                form.
                NOTE: Hemolysis will not be observed in an ABO forward grouping,
                Rh typing, IAT or DAT.
          4.1.3 Tilt the tube to an approximate 45o angle and mix the contents of the
                tube by gently rocking and tilting the tube until the red cell “button”
                is completely dislodged from the bottom.
                If the tube has been correctly centrifuged, the cell button will be well
                formed and will dislodge easily.
                CAUTION: Weak agglutination can be easily broken up if tubes are shaken
                too hard resulting in false negative test results.
          4.1.4 Observe the red cell “button” for agglutination as it is being dislodged.
                • If there is no agglutination, red cells will appear as a firm round “button”
                  with a smooth edge.
                • If agglutination is present, the “button” of cells will spread over a larger
                  area and will generally have an irregular, serrated or granular edge.
          4.1.5 Stop mixing the contents of the tube as soon as all the red cells are
                dislodged.
Module	2	(Crossmatch)		•	MP.007
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 4
          4.1.6 Grade and record the reactions immediately as each tube is read (as
                described in Table 1).
          4.1.7 Interpret the grading(s).
                • No agglutination or no hemolysis of the red cells is a negative test result.
                • Agglutination or hemolysis of the red cells is a positive test result.
                • A cloudy background with some large agglutinates may indicate a mixed
                  population of red cells (i.e. mixed field). Refer to procedural note 6.3.
Table 1: Grading Tube Reactions
 Record        Description of Tube Reaction
 0 or -        No agglutination or no hemolysis of red cells. Even red cell suspension.
 W             Appears macroscopically negative, however, microscopic agglutination
               is present.
 1+            Visible macroscopically. Red cell “button” breaks up into many small
               agglutinates. Background is cloudy.
 2+            Visible macroscopically. Red cell “button” breaks up into many small to
               medium agglutinates. Background is cloudy.
 3+            Visible macroscopically. Red cell “button” breaks up into large agglutinates.
               Background is clear.
 4+            Visible macroscopically. Solid red cell “button”. Background is clear. No free
               red cells.
 H             Hemolysis. Will vary from a slight reaction with some intact red cells to
               complete lysis of the red cells. Report if hemolysis is present in the tube but
               not in the specimen.
 Mf            Mixed field. A pattern of small red cell agglutinates among many free red
               cells. (refer to procedural note 6.3)
 R             Rouleaux. Appears microscopically as red cells stacking like coins.
 NT            Not tested.
      NOTE: Must be written exactly as above. “Do not use” half grade, superscript or
      “multiple plus signs” (e.g. ++s, etc).
      4.2 Gel Reactions
          4.2.1 Remove the card(s) from the centrifuge and examine each card for signs
                of improper centrifugation.
                • Unagglutinated red cells observed throughout the gel (appear pink
                  or hazy) in all microtubes on the card is usually caused by insufficient
                  centrifugation.
                • A line of red cells streaming down one side of the microtube and forming
                  a “J” shape, or the shifting of the red cell pellet from the bottom of the
                  microtube, is usually caused by improper seating of the card in the card
                  holders during centrifugation.
                • If the card(s) show signs of improper centrifugation, repeat the test(s)
                  ensuring correct placement of the cards and sufficient centrifugation time.
                  Do not re-centrifuge the original test(s).
                                                                        Module	2	(Crossmatch)		•	MP.007
2 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                      Version 2 • June 2007
          4.2.2 Examine both the front and back of each microtube in the gel card
                macroscopically for hemolysis and agglutination (a light box may be helpful).
          4.2.3 Grade and record the reactions immediately as each microtube is read.
                • Refer to the MTS™ Interpretation Guide for diagrams or pictures showing
                  ranges of reactions.
                • Record reactions on the request form as described in Table 2.
          4.2.4 Interpret the grading(s).
                • No agglutination or no hemolysis of the red cells is a negative test result.
                • Agglutination or hemolysis of the red cells is a positive test result.
                • A band of red cell agglutinates on top of the gel, accompanied by a pellet
                  of agglutinated red cells in the bottom of the microtube indicates a mixed
                  field reaction. Refer to procedural note 6.3.
Table 2: Grading Gel Reactions
 Record        Description of Tube Reaction
 0 or -        No agglutination or no hemolysis of red cells with unagglutinated red cells
               forming a well defined pellet in the bottom of the microtube. If a few
               unagglutinated red cells are trapped at the top or sides of the gel
               (refer to procedural note 6.2).
 W             A few red cell agglutinates in the middle or just above the disrupted red
               cell pellet.
 1+            Red cell agglutinates are predominantly observed in the lower half of the
               microtube. Unagglutinated red cells form a pellet in the bottom of the
               microtube.
 2+            Red cell agglutinates are dispersed throughout the length of the gel
               column. A few agglutinates may be observed in the bottom of the
               microtube.
 3+            Majority of red cell agglutinates are trapped in the upper half of the
               microtube.
 4+            A solid band of red cell agglutinates on top of the gel. A few agglutinates
               may filter into the gel, but remain near the predominant band.
 H             Hemolysis. Few or no red cells in the gel. Report if hemolysis is present in
               the microtube but not in the specimen.
 Mf            Mixed field. A pattern of small red cell agglutinates among many free red
               cells. (refer to procedural note 6.3)
 R             Mixed field. A band of red cell agglutinates on top of the gel, accompanied
               by a pellet of agglutinated red cells in the bottom of the microtube. (refer
               to procedural note 6.3).
 NT            Not tested.

NOTE: Must be written exactly as above. “Do not use” half grade, superscript or
“multiple plus signs” (e.g. ++s, etc).


Module	2	(Crossmatch)		•	MP.007
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 3 of 4
5.0 Reporting
        N/A

6.0 Procedural Notes
        6.1 ABO group, Rh type, or immediate spin crossmatch:
           • Read the tube(s) macroscopically, unless a discrepancy or a problem is suspected.
           • Microscopic examination may be required if mixed field agglutination or
             rouleaux is suspected. If mixed field is observed, record “mf”.
        6.2 Negative gel reaction:
           • Debris, fibrin or other artifacts associated with frozen specimens may cause a
             few unagglutinated red cells to be trapped on the top or sides of the gel. These
             tests should be repeated. If the problem persists, notify the manufacturer.
           • Previously frozen specimens should be centrifuged prior to use.
        6.3 When interpreting a reaction as mixed field, consider the following:
           • The clinical history of the patient.
           • The type of testing performed.
           • The source of the red cells used in the testing (e.g. mixed field reactions are
             usually not suspected when performing an antibody screen because the red
             cells are not pooled).
           • Strong cold agglutinins may give a mixed field appearance. These reactions
             are not truly mixed field and should be interpreted as positive.



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                                                                                 Module	2	(Crossmatch)		•	MP.007
4 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                       MP.008		
                                      ABO Testing


1.0 Principle
      1.1 To determine the ABO group in human blood.
      1.2 ABO blood groups are determined by the presence or absence of A and B
          antigens on the red cells and by the presence or absence of anti-A and anti-B in
          the plasma.

2.0 Scope and Related Policies
      2.1 The ABO group shall be determined by testing the patient’s red cells with anti-A
          and anti-B grouping reagents, and by testing the patient’s plasma using A1 and B
          reagent red cells.
      2.2 The results of the red cell and plasma tests should agree. Any ABO discrepancy
          should be investigated and resolved with appropriate documentation before
          issuing red cells.
      2.3 In cases where there is an ABO discrepancy and transfusion is required before
          the discrepancy is resolved, only Group O red cells shall be issued.
      2.4 If the test cells are reactive with anti-A, anti–B and anti-D then a patient control
          should be performed.

3.0 Materials
      Serologic centrifuge
      Work block(s)
      Transfer pipettes
      Tubes (10mm X 75mm, 12mm X 75mm)
      Anti-A and anti-B
      A1 and B reagent red cells
      0.9% saline

4.0 Procedure
      4.1 Add the appropriate ABO reagent to the tubes according to the manufacturer’s
          instructions:
          1 drop of anti-A to the tube labelled “A”
          1 drop of anti-B to the tube labelled “B”
          1 drop of A1 cells to the tube labelled “AC”
          1 drop of B cells to the tube labelled “BC”
      4.2 Add plasma to the appropriate labelled test tubes:
          2 drops to the tube containing A1 cells, labelled “AC”
          2 drops to the tube containing B cells, labelled “BC”
          2 drops to control labelled “Rh C”, if applicable

Module	2	(Crossmatch)		•	MP.008
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
      4.3 Add the unwashed 3% red cell suspension to the appropriate labelled tubes:
          1 drop to the tube containing anti-A, labelled “A”
          1 drop to the tube containing anti-B, labelled “B”
          1 drop to control labelled “Rh C”, if applicable
      4.4 Mix the contents of each tube.
      4.5 Examine the tubes for appearance and volume.
          If the volume and/or appearance are not consistent, discard the tubes and repeat
          set-up of all tests.
      4.6 Centrifuge the tubes. Suggested time/rpm: 15 seconds at 3,400 ± 200 rpm (high
          setting on serologic centrifuge).
      4.7 Remove the tubes from the centrifuge and return to the correct work block.
      4.8 Re-suspend the cells.
      4.9 Read the tubes macroscopically.
      4.10 Record test results.
           Ensure the “unique identifier” on each tube is identical to the corresponding
           information on the request form.
      4.11 Re-read the reactions in the tubes.
      4.12 Record the ABO interpretation (refer to Table 1) on the request form.
      4.13 Compare the interpretation with the original recorded results to ensure that the
           results and the interpretation match.
          If an ABO discrepancy exists (patient cells and plasma do not react as described
          in Table 1), it must be resolved before reporting the ABO group.
      4.14 Compare the ABO interpretation with the previous (historical) ABO group,
           if available.
          If there is a discrepancy between the current and previous ABO group, it must be
          resolved before reporting the ABO group.
          NOTE: If an ABO discrepancy is detected, and transfusion is necessary before
          resolution, issue only Group O Rh compatible red cell units until the problem
          is resolved.

5.0 Reporting
      5.1 If patient cells and plasma react as described in Table 1, record the appropriate
          ABO interpretation on the request form.
Table 1: Interpreting ABO Test Results
 Patient cells versus      Patient plasma versus               Interpretation
 Anti-A          Anti-B    A1 cells       B cells              Rh C         Group
 Neg               Neg                Pos                Pos   n/a              O
 Pos               Neg                Neg                Pos   n/a              A
 Neg               Pos                Pos                Neg   n/a              B
 Pos               Pos                Neg                Neg   Neg              AB
 Pos               Pos                n/a                n/a   Pos              Indeterminate
                                                                     Module	2	(Crossmatch)		•	MP.008
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                   Version 2 • June 2007
NOTE: Positive reactions with anti-A and/or anti-B should be 2+ or stronger with patient
red cells (forward group). Weaker reactions require further investigation.
          • Positive reactions with A1 and B reagent red cells should be 1+ or stronger with
            patient plasma (reverse group). Weaker reactions require further investigation.
          • If hemolysis is observed in the reverse group and the pre-testing plasma was
            not hemolyzed, then interpret the hemolysis as a positive reaction.
          • A mixed field reaction may be observed if a patient has been transfused with
            ABO compatible red cells other than the patient’s own ABO group (i.e. Group O
            red cells transfused to a Group A patient).
       5.2 ABO Discrepancy
          Do not report the ABO group until the discrepancy is resolved.
          5.2.1 An ABO discrepancy exists when the patient cells and plasma do not react
                as described in Table 1.
                • Indeterminant results require further investigation.
          5.2.2 Send out specimens to CBS for further investigation if necessary.
6.0 Procedural Notes
       6.1 Rh C tube: 1 drop of 6% Albumin or commercially prepared Rh Control Reagent
           may be used in place of patient plasma (see Anti D package insert).



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Module	2	(Crossmatch)		•	MP.008
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                        MP.009		
                                        Rh Testing


1.0 Principle
      1.1 To determine the Rh (D) type in human blood.
      1.2 The Rh (D) type is determined by the presence or absence of the D antigen on
          the red cells.

2.0 Scope and Related Policies
      2.1 The Rh type shall be determined by testing the patient red cells with anti-D
          typing reagent.
      2.2 A control system, appropriate to the anti-D reagent in use, shall be included. If
          this control is positive, the Rh typing shall be repeated with an appropriate anti-D
          reagent and control.
      2.3 It is not necessary to perform weak D testing on patients whose red cells type as
          Rh negative.
      2.4 Testing for Weak D shall be performed on any infant who types as Rh negative
          if the mother is Rh negative.
      2.5 The Rh type shall be retested on all Rh negative donor red cell units prior
          to transfusion (testing for weak D is not required for confirmation testing).
      2.6 If an Rh typing discrepancy is detected, and transfusion is necessary before
          resolution, only Rh negative red cells should be issued until the problem
          is resolved.

3.0 Materials
      Serologic centrifuge
      Work block(s)
      Transfer pipettes
      Tubes (10mm x 75mm, 12mm x 75mm)
      Anti-D
      0.9% saline

4.0 Procedure
      4.1 Add the appropriate Rh reagent to the tubes according to the manufacturer’s
          instructions:
          • 1 drop of the first anti-D to the tube labelled “DI.”
          • 1 drop of the second anti-D to the tube labelled “DII.”
      4.2 Add 2 drops of patient plasma, or 1 drop of 6% albumin, or commercially
          prepared Rh control reagent to the tube labelled “Rh C”, as applicable.


Module	2	(Crossmatch)		•	MP.009
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
      4.3 Add the 3% patient red cell suspension to the appropriate labelled tubes:
          • 1 drop to the tube labelled “DI”
          • 1 drop to the tube labelled “DII”
          • 1 drop to the tube containing patient plasma, or 6% albumin, or commercially
            prepared Rh control reagent, labelled “Rh C”, as applicable
      4.4 Mix the contents of each tube.
      4.5 Examine the tubes for appearance and volume. If the volume and/or appearance
          are not consistent, discard the tubes and repeat set-up of all tests.
      4.6 Centrifuge the tubes. Suggested time/rpm: 15 seconds at 3,400 ± 200 rpm (high
          setting on serologic centrifuge).
      4.7 Remove the tubes from the centrifuge and return to the correct work block.
      4.8 Re-suspend the cells.
      4.9 Read the tubes macroscopically for direct agglutination
      4.10 Record test results.
          • Ensure the “unique identifier” on each tube is identical to the corresponding
            information on the request form
      4.11 Re-read the reactions in the tubes and record the Rh interpretation (refer to Table
           1) on the request form.
      4.12 Compare the interpretation with the original recorded results to ensure that the
           results and the interpretation match.
          • If an Rh discrepancy exists (patient cells do not react as described in Table 1),
            it must be resolved before reporting the Rh type.
      4.13 Compare the Rh interpretation with the previous (historical) Rh type, if available.
          • If there is a discrepancy between the current and previous Rh type, it must be
            resolved before reporting the Rh type.
            NOTE: If crossmatched red cells are required before the discrepancy can be
            resolved, select only Rh negative red cell units for crossmatch until the Rh
            type is determined.

5.0 Reporting
      5.1 If patient red cells react as described in Table 1, record the appropriate Rh
          interpretation on the request form.
Table 1: Interpreting Rh Test Results
 Patient cells versus                                          Interpretation
 Anti-DI           Anti-DII                Rh Control          Rh Type
 Pos               Pos                     Neg                 Pos
 Neg               Neg                     Neg                 Neg
 Pos               Neg                     Neg                 Indeterminant
 Neg               Pos                     Neg                 Indeterminant
 Pos               Pos                     Pos                 Indeterminant
                                                                                Module	2	(Crossmatch)		•	MP.009
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                              Version 2 • June 2007
NOTE:
• Positive reactions with anti-D should react 2+ or stronger with patient red cells. Weaker
reactions require further investigation.
• A mixed field reaction may be observed if a patient has been transfused with Rh
compatible red cells other than the patient’s own Rh type (i.e. Rh negative red cells
transfused to an Rh positive patient).
       5.2 Rh Discrepancy
       Do not report the Rh type until the problem is resolved.
       1. If patient red cells do not react as described in Table 1, an Rh discrepancy exists.
       2. Send out specimens to CBS for further investigation, if necessary.

6.0 Procedural Notes
       N/A




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   Approved	by:	    											__________________________________	       __________________________________
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   Facility	effective	date:			__________________________________
   	         	      	       									(Date	of	implementation)




Module	2	(Crossmatch)		•	MP.009
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                         MP.010		
     Cell Washing for Antiglobulin: Automated and Manual


1.0 Principle
      The cell washing process must remove unbound human plasma globulin from the
      test system before the addition of antihuman globulin (AHG) reagents.
      • If there is inadequate washing of red cells, the residual unbound globulin may
        neutralize the antihuman globulin.
      • Neutralization will be detected by the failure of IgG coated red cells (control cells)
        to agglutinate the red cells of a negative test, thus resulting in an invalid test
        result.

2.0 Scope and Related Policies
      2.1 When performing an antiglobulin test, the red cells shall be washed 4 times after
          the incubation phase, before the addition of AHG.
      2.2 When performing an antiglobulin test, once the wash phase has been initiated,
          the washing and the testing shall be carried through to the reading phase
          without interruption (within 5 minutes).

3.0 Materials
      Automated cell washer
      Serologic centrifuge
      Tubes (10mm X 75mm, 12mm X 75mm)
      0.9% saline

4.0 Procedure
      4.1 Automated Cell Washing
          4.1.1 Follow the manufacturer’s specific instructions for operating the cell washer.
          4.1.2 Place the tube(s) in the holder of the cell washer. Balance the tubes for
                centrifugation.
          4.1.3 Wash the tube(s) 4 times. Press the appropriate touch-pad or turn the dial
                to 4 washes.
          4.1.4 After the last wash, check that:
                • The saline has been decanted.
                • A dry cell “button” is left in each tube (i.e. minimal residual saline in
                  each tube).
                • The size of the cell button is consistent (approximately 3 to 4 mm
                  diameter).



Module	2	(Crossmatch)		•	MP.010
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
        4.2 Manual Cell Washing
          4.2.1 Fill the tube with saline. Direct the saline into the bottom of the tube so that
                the red cells are mixed homogeneously. Leave approximately 1 cm from the
                top of the tube empty.
                  CAUTION: Avoid contamination from one tube to the next while dispensing
                  saline into several tubes.
          4.2.2 Centrifuge the tube(s). Suggested time/rpm: 45 to 60 seconds at 3,400 ± 200
                rpm (high setting on serologic centrifuge).
          4.2.3 After centrifugation, check that the red cells are packed at the bottom of
                the tube.
                  • If a line of red cells has formed along the side of the tube, the
                    centrifugation time should be extended until all the red cells are packed
                    at the bottom of the tube.
          4.2.4 Decant the saline from the tube(s) by quick inversion. Leave the red cell
                “button” as intact as much as possible.
          4.2.5 Turn the tube(s) upright. Mix the tube(s) gently to dislodge the red cell
                “button”.
          4.2.6 Repeat steps 4.2.1 through 4.2.5 for a total of 3 to 4 washes as required.
          4.2.7 After the last wash, check that:
                  • There is minimal residual saline remaining (either by giving the tube an
                    extra shake or by blotting the tube).
                    The size of the cell button is consistent (approximately 3 to 4 mm diameter).

5.0 Reporting
        N/A

6.0 Procedural Notes
        N/A




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                                                                                  Module	2	(Crossmatch)		•	MP.010
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                                Version 2 • June 2007
                                         MP.011		
                                  Indirect Antiglobulin Test


1.0 Principle
      1.1 The IAT is used to demonstrate in vitro coating of red cells with antibody
          achieved by incubating red cells (screening cells) with patient plasma at 37°C.
          Red cell antibodies may cause direct agglutination or lysis of red cells, or may
          coat the red cells with IgG.
      1.2 For the detection of indirect agglutination, the red cells are then washed to
          remove unbound globulin, and tested with antihuman globulin (anti-IgG). In the
          gel method, the red cells are centrifuged (without washing) through a dextran-
          acrylamide gel layer containing AHG.
      1.3 Indirect agglutination detected with the use of AHG indicates that the red cells
          (screening cells) have been coated with globulin (i.e. IgG and/or C3). Clinically
          significant antibodies detected by the AHG phase are usually from the Rh, Kell,
          Duffy, Kidd, and MNS systems.

2.0 Scope and Related Policies
      2.1 Patient plasma should be tested using methods that will detect clinically
          significant antibodies. Methods must include a 37°C incubation phase
          preceding an antiglobulin test, using reagent red cells that have not been
          pooled. Alternative test methods may be used provided that documentation
          of comparable sensitivity is available.
      2.2 The following test methods may be used for the antibody screening:
          • IAT Gel Method
          • IAT Saline Method
          • IAT PEG Method
      2.3 The use of an antiglobulin reagent containing Anti-IgG is required when
          performing an indirect antiglobulin test.
      2.4 A minimum of two reagent red cells that express a wide variety of blood group
          antigens shall be used for antibody screening. Reagent red cells with a double
          expression of antigens should be used to detect unexpected antibodies to red
          cell antigens.
      2.5 An antiglobulin crossmatch shall be performed on any patient with a positive
          antibody screen or a history of antibodies.
      2.6 When a patient has clinically significant Ab(s) identified, the donor units must
          lack the corresponding Ag and be crossmatched by an indirect antiglobulin test.




Module	2	(Crossmatch)		•	MP.011
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
3.0 Materials
        Gel IAT:
        MTS™ Centrifuge
        MTS™ Incubator
        MTS™ Pipettor: 25 μL, 50 μL
        MTS™ Set-up workstation (optional)
        MTS™ ID-Tips (pipette tips)
        0.8% red cell suspension
        MTS™ Anti-IgG cards
        Tube IAT (PEG/Saline):
        Centrifuge or cell washer
        37°C Incubator
        Work block(s)
        Tubes
        Transfer pipettes
        3% red cell suspension
        Anti- IgG anti-human globulin
        IgG-coated control cells
        0.9% saline
        PEG (20% polyethylene glycol), if applicable

4.0 Procedure
        Refer to MP.011A (Gel Method), MP.011B (Saline Method) and MP.011C
        (PEG Method)

5.0 Reporting
        Refer to MP.011A (Gel Method), MP.011B (Saline Method) and MP.011C
        (PEG Method)

6.0 Procedural Notes
        Refer to MP.011A (Gel Method), MP.011B (Saline Method) and MP.011C
        (PEG Method)



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

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    	       	       	       									(Date	of	implementation)




                                                                                 Module	2	(Crossmatch)		•	MP.011
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                    MP.011A		
                  Indirect Antoglobulin Test – Gel Method


1.0 Principle
      Refer to MP.011

2.0 Scope and Related Policies
      Refer to MP.011

3.0 Materials
      Refer to MP.011

4.0 Procedure
      Theory:
      Reagent screen cells or donor red cells, suspended in a hypotonic buffered saline
      solution, are combined with patient plasma in the upper reaction chamber of the
      gel microtube to allow antigen/antibody interaction. Incubation at 37°C promotes
      antibody uptake.
      The gel test employs the principle of controlled centrifugation of red cells through
      a dextran-acrylamide gel layer. The Micro Typing System (MTS™) anti-IgG card is
      designed to restrict the unbound IgG from moving through the gel layer during
      centrifugation. Thus, unbound IgG does not neutralize the anti-IgG incorporated in
      the gel. Agglutinated red cells become trapped in or at the surface of the gel layer.
      Unagglutinated red cells travel through the gel particles and form a pellet at the
      bottom of the microtube.
      4.1 Inspect the gel card(s). Remove the foil seal for the required number of
          microtubes immediately before testing (refer to procedural note 6.1 and 6.2).
      4.2 Pipette 50 μL of the appropriate 0.8% red cell suspension to each labelled
          microtube (refer to procedural note 6.3).
      4.3 Pipette 25μL of patient plasma to each labelled microtube (refer to procedural
          note 6.3).
      4.4 Examine each microtube for appropriate volume and appearance. If the volume
          and/or appearance is not consistent, discard the microtubes and repeat set up
          of all tests.
      4.5 Incubate the gel card(s) at 37°C for 15 minutes to a maximum of 30 minutes.
          Record in-time and temperature on the worksheet.
      4.6 After incubation, remove the gel card(s) from the incubator and examine each
          microtube for a supernatant above the settled cells. Record the out-time and
          temperature on the worksheet


Module	2	(Crossmatch)		•	MP.011A
Version 2 • June 2007                       Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
      4.7 Centrifuge the gel card(s) in the MTS™ centrifuge at the preset specifications:
          10 minutes at 900 rpm.
      4.8 After centrifugation, examine the gel card(s) for signs of improper centrifugation.
      4.9 Examine each side of the gel card macroscopically for agglutination or hemolysis.
      4.10 Record test results on the request form (refer to procedural note 6.4).
      4.11 Interpret and report the antibody screen and/or determine compatibility of
           donor units.

5.0 Reporting
      5.1 Antibody Screen
          Refer to MP.012
      5.2 Donor Unit Compatibility
          Refer to MP.014

6.0 Procedural Notes
      6.1 Inspecting gel cards before use.
          • Do not freeze or expose cards to excessive heat. Store upright at 2 to 25°C.
            If the cards have not been stored in an upright position, centrifuge the cards
            before use.
          • Do not use cards that show signs of drying. A liquid layer should appear on top
            of the gel in each microtube.
          • Do not use cards in which the microtubes show discoloration, bubbles or
            crystals.
          • Do not use the microtube if the seal to the microtube appears to be damaged
            or opened.
      6.2 Removing the foil seal from the gel cards before use.
          • Unsealed microtube(s) should be used within 60 minutes. Reagent evaporation
            may occur if microtubes are left unsealed for a longer period of time.
          • Unused sealed microtubes, on a gel card that has been incubated and
            centrifuged, may be used up to the date of expiration of the particular MTS™
            card.
          • A sealed card that has been repeatedly centrifuged is not suitable for patient
            testing. A card should be designated as a balance and clearly marked.
      6.3 Adding 0.8% red cell suspensions and patient plasma to the gel microtubes.
          • The 0.8% red cell suspension is added before the plasma as insufficient mixing
            may occur if the smaller volume of plasma (25 μL ) is added before the volume
            of red cell suspension (50 μL).
          • If plasma is not added to the upper reaction chamber within 10 to 15 minutes of
            adding the red cell suspension, the red cells (that come in contact with the gel
            layer prior to centrifugation) may begin to migrate through the gel layer before
            having the opportunity to come in contact with the plasma, thus potentially
            giving a weaker reaction after centrifugation.

                                                                    Module	2	(Crossmatch)		•	MP.011A
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                   Version 2 • June 2007
       6.4 Reading gel reactions.
          • The manufacturer recommends that reactions should be read immediately
            following centrifugation. Test results may be affected by drying of the gel,
            hemolysis of the red cells or slanting of the reaction patterns due to storage
            in a non upright position after centrifugation.
          • Rouleaux, which may be caused by plasma with an abnormally high
            concentration of protein or from patients who have received plasma
            expanders of high molecular weight, may cause a false positive test result.
          • Too few or too many red cells in the microtube, which may cause false positive
            or false negative test results, may be due to improperly prepared 0.8% red cell
            suspension or the incorrect volume of 0.8% red cell suspension pipetted to the
            upper reaction chamber of the microtube. If this is the case, then repeat the
            test(s) with a new 0.8% red cell suspension. Ensure that the correct volume
            has been pipetted to the upper reaction chamber of the microtube.



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Module	2	(Crossmatch)		•	MP.011A
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                     MP.011B		
           Indirect Antiglobulin Test – Saline Method Test


1.0 Principle
      Refer to MP.011

2.0 Scope and Related Policies
      Refer to MP.011

3.0 Materials
      Refer to MP.011

4.0 Procedure
      4.1 Add 4 drops of patient plasma to each labelled tube.
      4.2 Add 1 drop of the appropriate 3% red cell suspension to each labelled tube.
      4.3 Mix the contents of each tube.
      4.4 Examine the tubes for appropriate volume and appearance. If the volume and/or
          appearance is not consistent, discard the tubes and repeat set-up of all tests.
      4.5 Incubate the tubes at 37°C for 30 minutes. Record the in-time and temperature
          on the worksheet.
          • The incubation time may be extended to 60 minutes, if necessary.
      4.6 After incubation, record the out-time and temperature on the worksheet.
          Wash the tubes 3 to 4 times with saline.
      4.7 Add 2 drops of anti-IgG anti-human globulin reagent to each tube.
          • After the wash cycle is complete, anti-IgG should be added to the dry cell
            “button” as soon as possible. If a delay of more than 5 minutes occurs,
            the tests must be repeated.
      4.8Mix the contents of each tube.
      4.9Centrifuge the tubes. Suggested time/rpm: 15 seconds at 3,400 ± 200 rpm
         (high setting on serologic or cell washer centrifuge).
      4.10 Gently re-suspend the cells immediately after centrifugation.
          • Following centrifugation, the tests should be read immediately. If a delay
            of more than 2 minutes occurs, the tests must be repeated.
      4.11 Read the tubes macroscopically for agglutination.
      4.12 Record test results on the request form.
      4.13 Add 1 drop of IgG-coated control cells to the tube(s) with negative test results.
      4.14 Mix the contents of each tube.


Module	2	(Crossmatch)		•	MP.011B
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
        4.15 Centrifuge the tubes. Suggested time/rpm: 15 seconds at 3,400 ± 200 rpm (high
             setting on serologic centrifuge).
        4.16 Gently re-suspend the cells.
        4.17 Read the tubes macroscopically.
        4.18 Record test results on the request form.
           • Agglutination 2+ or greater must be present, otherwise the test(s) must
             be repeated.
        4.19 Interpret and report the antibody screen and/or determine compatibility
             of donor units.

5.0 Reporting
        5.1 Antibody Screen
            Refer to MP.012
        5.2Donor Unit Compatibility
           Refer to MP.014

6.0 Procedural Notes
        N/A



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                                                                                Module	2	(Crossmatch)		•	MP.011B
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                     MP.011C		
                  Indirect Antiglobulin Test – PEG Method


1.0 Principle
      Refer to MP.011

2.0 Scope and Related Policies
      Refer to MP.011

3.0 Materials
      Refer to MP.011

4.0 Procedure
      Theory:
      PEG is a potentiating medium used to enhance the reactivity of antibodies and to
      shorten the incubation time required for antigen-antibody reactions to take place.
      4.1 Add 2 drops of patient plasma to each labelled tube.
      4.2 Add 1 drop of the appropriate 3% red cell suspension to each labelled tube.
          • Patient and donor unit cell suspensions should be washed once prior to testing.
      4.3 Add 2 drops of PEG to each tube.
      4.4 Mix the contents of each tube.
      4.5 Examine the tubes for appropriate volume and appearance.
          • If the volume and/or appearance are not consistent, discard the tubes and
            repeat set-up of all tests.
      4.6 Incubate all tubes at 37°C for 10 minutes. Record the in-time/temperature on
          the worksheet.
          • The incubation time may be extended to 30 minutes, if necessary.
      4.7 After incubation, record the out-time/temperature on the worksheet. Wash the
          tubes 4 times with saline.
      4.8 Add 2 drops of anti-IgG anti-human globulin reagent to each tube.
          • After the wash cycle is complete, anti-IgG should be added to the dry cell
            “button” as soon as possible. If a delay of more than 5 minutes occurs,
            the tests must be repeated.
      4.9 Mix the contents of each tube.
      4.10 Centrifuge the tubes for 15 seconds at 3,400 ± 200 rpm (high setting on serologic
           or cell washer centrifuge).



Module	2	(Crossmatch)		•	MP.011C
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
        4.11 Gently re-suspend the cells immediately after centrifugation.
           • Following centrifugation, the tests should be read immediately. If a delay
             of more than 2 minutes occurs, the tests must be repeated.
        4.12 Read the tests macroscopically for agglutination.
        4.13 Record results on the worksheet.
        4.14 Add 1 drop of IgG-coated control cells to the tube(s) with negative test results.
        4.15 Mix the contents of each tube.
        4.16 Centrifuge the tubes for 15 seconds at 3,400 ± 200 rpm (high setting on serologic
             or cell washer centrifuge).
        4.17 Gently resuspend the cells.
        4.18 Read the tests macroscopically for agglutination.
        4.19Record results on the worksheet.
           • Agglutination 2+ or greater must be present otherwise the test(s) must
             be repeated.
        4.20 Interpret and report the antibody screen and/or determine compatibility
             of donor units.

5.0 Reporting
        N/A

6.0 Procedural Notes
        6.1 If reproducible 1+ or negative IgG control cell results (not due to a technical
            problem) are obtained with all or most PEG IAT tests on a patient they may be
            caused by the patient’s clinical condition. Perform a Saline IAT antibody screen.



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                                                                                Module	2	(Crossmatch)		•	MP.011C
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                         MP.012		
                                  Antibody Screen Reporting


1.0 Principle
      To interpret and report antibody screen test results.

2.0 Scope and Related Policies
      When an antibody screen is positive:
      • Notify the physician/authorized practitioner, if applicable.
      • The patient specimen(s) may be sent to CBS for an antibody investigation.

3.0 Materials
      N/A

4.0 Procedure
      N/A

5.0 Reporting
      5.1 Antibody Screen Negative
          No agglutination of the screening cells indicates that clinically significant
          antibodies were not present or were undetected.
          Report the antibody screen as negative.
          For patients with a previous positive antibody screen, the antibody(ies) may
          no longer be detectable.
      5.2 Antibody Screen Positive
          Agglutination of the screening cells may indicate the presence of antibodies.
          Report the antibody screen as positive.
          Follow-up testing is required for all positive antibody screens. Send specimen(s)
          to CBS for further investigation, if necessary.
          In an emergency situation, screen for crossmatch compatible donor units by IAT.
          Record the following on the report:
          “Unexpected antibodies detected. Donor units are crossmatch compatible.”




Module	2	(Crossmatch)		•	MP.012
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
6.0 Procedural Notes
        N/A




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                                                                                 Module	2	(Crossmatch)		•	MP.012
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                         MP.013		
                              Immediate Spin Crossmatch


1.0 Principle
      To ensure ABO compatibility between the patient plasma and donor red cells.

2.0 Scope and Related Policies
      2.1 If the antibody screen is negative, and there is no history of clinically significant
          antibodies, a test to confirm ABO compatibility between donor red cells and
          patient plasma shall be performed.
      2.2 An immediate spin crossmatch shall not be performed on any patient with a
          positive antibody screen or a history of antibodies. An antiglobulin crossmatch
          shall be performed in these cases.

3.0 Materials
      Serologic centrifuge
      Work block(s)
      Tubes
      Transfer pipettes
      Unwashed 3% donor red cell suspension
      0.9% saline

4.0 Procedure
      4.1 Add 2 drops of patient plasma to each labelled tube.
      4.2 Add 1 drop of the appropriate 3% donor red cell suspension to each tube
          labelled with a corresponding donor unit number.
      4.3 Mix the contents of each tube.
      4.4 Examine the tubes for appropriate volume and appearance.
          • If the volume and/or appearance is not consistent, discard the tubes and repeat
            set up of all tests.
      4.5 Centrifuge the tubes. Suggested time/rpm: 15 seconds at 3,400 + 200 rpm (high
          setting on serologic centrifuge).
      4.6 After centrifugation, examine the supernatant for hemolysis. (Refer to procedural
          note 6.1).
      4.7 Re-suspend the cells.
      4.8 Read the tubes macroscopically.
      4.9 Record test results on the request form.
          • If the test result is positive, refer to procedural note 6.2.
      4.10 Determine compatibility of donor units.

Module	2	(Crossmatch)		•	MP.013
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
5.0 Reporting
        Donor Unit Compatibility
        Refer to MP.014

6.0 Procedural Notes
        6.1 If hemolysis is present in the test but not in the original specimen, repeat the test.
           • Prepare a new 3% cell suspension washing the donor cells once with saline.
           • If the hemolysis is still present refer the specimen to CBS.
           • If an urgent transfusion is necessary, consult with the BTS Medical Director
             before issuing any donor units.
        6.2 If the test result is positive:
           • Prepare a new 3% cell suspension from the donor unit. Wash the donor cells
             once. Repeat the crossmatch by immediate spin.
           • If the test result is still positive
           • Incubate at 37°C for 5 minutes, re-spin, and re-read test results.
           • If the test result is still positive perform Saline Addition and Replacement
             Technique
           • If the test result is still positive perform an IAT crossmatch, if IAT result is
             negative units may be issued.
        6.3 If still positive refer to CBS for investigation


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                                                                                 Module	2	(Crossmatch)		•	MP.013
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                        MP.014		
        Determining Compatibility of Donor Red Cell Units


1.0 Principle
      To determine the compatibility of donor red cell units.

2.0 Scope and Related Policies
      2.1Donor red cell units shall be crossmatched by the appropriate method and issued
         only if determined to be compatible.
      2.2 Incompatible units shall only be issued with the approval of the BTS Medical
          Director.
      2.3 An antiglobulin crossmatch shall be performed on any patient with a positive
          antibody screen or a history of antibodies.
      2.4 When a patient has clinically significant Ab(s) identified, the donor units must
          lack the corresponding Ag and be crossmatched by an indirect antiglobulin test.

3.0 Materials
      N/A

4.0 Procedure
      N/A

5.0 Reporting
      Determine the compatibility of donor red cell units according to the following
      criteria:
      5.1 Donor Units are Compatible
          A negative crossmatch indicates the donor units are compatible with the patient
          plasma and are suitable for issue if there is:
          • no agglutination
          • no hemolysis
          • no clinical history of antibodies
          NOTE: In addition, units for patients with clinically significant antibodies must
          lack the corresponding antigen and must be IAT crossmatch compatible.
      5.2 Donor Units are Crossmatch Compatible only
          Donor units are considered crossmatch compatible only when:
          • IAT crossmatch is negative and
          • Patient has a reactive antibody screen and the investigation is incomplete or
          • Patient has a history of clinically significant antibodies and antigen negative
            donor units are not available.
Module	2	(Crossmatch)		•	MP.014
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
          In an emergent situation, record the following on the report:
          “Unexpected antibodies detected. Donor units are crossmatch compatible.”
        5.3 Donor Units are Crossmatch Incompatible
          Incompatible donor units should not be issued without authorization by BTS
          Medical Director.
          If hemolysis is observed in the immediate spin crossmatch:
          • compare the supernatant with the pre-testing plasma to confirm that hemolysis
            was antibody induced.
          • If the pre-testing plasma was not hemolyzed, then interpret the hemolysis as
            a positive reaction.
          Agglutination or hemolysis of the donor red cells in the crossmatch indicates an
          incompatibility, possibly due to an ABO incompatibility or to another antibody
          in the patient plasma.
          • Follow-up testing is required.
          • Send the specimen to CBS for further investigation if necessary.
          If transfusion is unavoidable, notify the BTS Medical Director to obtain
          authorization prior to transfusion.
          This authorization must be documented on the report
          NOTE: These units must be ABO compatible with the recipient’s ABO group.
          In an emergency situation, record the following on the report:
              “Unexpected antibodies detected. Donor units are crossmatch incompatible.
              Transfuse only in emergent situations with caution.
              Dr. ________was notified _________ (date & time) and has consulted with the
              attending physicians/authorized practitioner.”
              Include initials of individual who notified the BTS Medical Director.
          NOTE: The BTS should have the attending physician/authorized practitioner’s
          contact information readily available for the BTS Medical Director.

6.0 Procedural Notes
        N/A



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                                                                                 Module	2	(Crossmatch)		•	MP.014
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                      MP.015		
      Pre-Transfusion Testing Requirements For Neonates
              (Small Volume Red Cell Transfusion)


1.0 Principle
      To outline the procedure used when a small volume red cell transfusion is requested
      for a neonate.

2.0 Scope and Related Policies
      2.1Neonates (patients under 4 months old) have unique pre-transfusion testing
         requirements.
      2.2 A cord blood specimen must NOT be used for pre-transfusion testing.
      2.3 The plasma of either the mother or the neonate may be used to perform the
          antibody screen and crossmatch.
      2.4 It is recommended that a maternal specimen be used for antibody investigation
          when the mother of the neonate has a clinically significant antibody or a passive
          antibody is detected in the neonate’s specimen.
      2.5 The reverse ABO group is omitted when testing neonates.
      2.6 Repeat ABO Rh typing may be omitted for the remainder of the neonate’s
          hospital admission or until the neonate reaches the age of 4 months, whichever
          is sooner.
      2.7 When the initial pre-transfusion antibody screen is negative, repeat antibody
          screening is not required during the neonate’s current hospital admission or
          until the neonate reaches the age of 4 months, whichever is sooner.
      2.8 When the initial pre-transfusion antibody screen is negative, further
          compatibility testing, during the neonate’s current hospital admission or until
          the neonate reaches the age of 4 months, whichever is sooner, is only required
          to confirm ABO compatibility (e.g. either by verification of the ABO group of
          the donor unit or by IS crossmatch)

3.0 Materials
      3.1 If maternal specimens available:
          Mother: 1 x 7 mL or 2 x 5 mL EDTA specimen
          Neonate: EDTA heel prick specimen
      3.2 If no maternal specimen available:
          Neonate: 1-2 mL EDTA specimen




Module	2	(Crossmatch)		•	MP.015
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 4
          NOTE: Cord blood specimens are unacceptable.

4.0 Procedure
      4.1 Check specimen(s) against requisition(s). Resolve any discrepancies before testing.
      4.2 If maternal and neonate specimens are available:
       Using the:                             Perform:
       Mother’s specimen                      • ABO/Rh
                                              • Antibody Screen
                                              • Antibody ID if antibody screen is positive
                                              • Crossmatch donor red cell unit
                                                 • By IS if antibody screen negative
                                                 and there is no history of antibodies
                                                 • By IAT if antibody screen positive or
                                                 there is a history of antibodies (if a
                                                 clinically significant antibody is present,
                                                 red cells must be antigen negative for
                                                 the corresponding antibody)
       Neonate’s specimen                     • ABO/Rh (omit reverse group)
                                              • DAT with anti-IgG

      4.3 If the maternal specimen is not available:
       Using the:                                        Perform:
       Neonate’s specimen                                • ABO/Rh (omit reverse group)
                                                         • DAT with anti-IgG
                                                         • Antibody Screen
                                                         • Antibody ID if antibody screen is positive
                                                         • Crossmatch donor red cell unit
                                                            • By IS if antibody screen negative
                                                            and no history of maternal antibodies
                                                            • By IAT, if antibody screen positive or
                                                            there is a history of maternal antibodies
                                                            (if a clinically significant antibody is
                                                            present, red cells must be antigen
                                                            negative for the corresponding antibody.)
                                                         NOTE: If the antibody screen is positive it is
                                                         recommended that a maternal specimen is
                                                         obtained for the antibody ID.
      NOTES:
      1. If the neonate has been transfused, e.g., IVT and the neonate’s ABO/Rh is the same
      ABO/Rh of the component transfused and no mixed field agglutination is observed
      then report the neonate’s ABO/Rh as “Indeterminate”.
      2. When mixed field agglutination is observed and the infant’s ABO and/or Rh can be
      determined, it may be reported out. The mixed field can be explained due to receipt
      of non-group specific red cells, e.g., IVT, exchange.


                                                                              Module	2	(Crossmatch)		•	MP.015
2 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                            Version 2 • June 2007
      4.4 Select the appropriate unit for crossmatch as outlined below:

       All red cell components must be :                 In addition, the component may be:
       • As fresh as possible, must be les than          • Rh specific
       14 days old                                       • A divided red cell unit
           • Select O Negative red cells unless
           mother has a significant antibody that
           is incompatible with O Negative (e.g.
           anti-c, anti-e)
       • Confirmed negative for the antigen
       corresponding to the maternal antibody if
       a clinically significant antibody is detected
       or there is a history of clinically significant
       maternal antibodies
       • The same ABO/Rh as the first component
       if the request is for subsequent components
       • Anti-CMV negative when the neonate’s
       birth weight is less than 1,200 g and the
       mother is anti-CMV negative or the status
       is unknown
       NOTE: in most cases the mother’s CMV
       status may not be easily obtainable.
      NOTES: If a component meeting all the criteria is not available consult with the BTS
      Medical Director. The BTS Medical Director will consult with the attending physician/
      authorized practitioner and advise the BTS.
      4.5 Perform the crossmatch as outlined in 4.2.

5.0 Reporting
      5.1 A requisition with the neonate’s demographics must be completed documenting
          the neonate’s ABO/Rh, antibody screen results and the compatible red cell unit.
          • If the antibody screen is positive also report the following:
            “Patient’s plasma contains anti- ___ which was acquired passively from his/her
            mother (insert mother’s name in full).”
      5.2 A red cell product chart copy with the neonate’s demographics must be completed.
      5.3 If the maternal specimen is used for testing record the following comment:
          “Testing performed using the maternal specimen.”
          In addition document the following on the neonate’s requisition:
          • The mother’s demographics
          • The collection date of the mother’s specimen
          • The mother’s ABO/Rh
          • The mother’s antibody screen and identification results



Module	2	(Crossmatch)		•	MP.015
Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks • 3 of 4
6.0 Procedural Notes
        N/A



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                                                                                 Module	2	(Crossmatch)		•	MP.015
4 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                         MP.016		
Handling Outdated Type and Screens / Patient Assigned Units


1.0 Principle
      1.1 To ensure the cancellation of all type and screen specimens and/or crossmatched
          units when outdated or cancelled prior to outdate.
      1.2 To ensure crossmatched units that expire during the specimen indate period
          are discarded.
      1.3 To ensure all other patient assigned blood components are cancelled
          or discarded.

2.0 Scope and Related Policies
      2.1 Type and screen specimen(s) and/or crossmatched units which have not been
          transfused within the specimen indate period must be cancelled.
      2.2 Crossmatched units that expire during the specimen indate period must
          be cancelled and discarded according to facility policy.
      2.3 The indate period for type and screens and/or crossmatched units is as
          per MP.002.
      2.4 Type and screens and/or crossmatched units may be cancelled prior to expiry.
      2.5 All other patient assigned blood components must be cancelled or discarded,
          as required.

3.0 Materials
      Type and screen specimen
      Labelled/tagged/assigned blood and blood components
      Issue/Transfusion Record (lab log)
      BTS Patient Report (if applicable)

4.0 Procedure
      4.1 Identify cancelled type and screen specimen(s) and assigned unit(s).
          4.1.1 Non-Crossmatch facilites:
                • Remove unit(s) from storage and complete the disposition portion of the
                  Issue/Transfusion Record (lab log) for each unit. Refer to Module 3 INV.010.
                • Remove the chart and/or blood bank copy of the tag from the unit. File or
                  discard, as applicable.
                • Discard or return units to BTS as per facility policy.




Module	2	(Crossmatch)		•	MP.016
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
           4.1.2 Crossmatch facilites:
                • If no products transfused, remove and discard outdated specimen.
                • If products transfused, retain specimen for a minimum of 7 days
                  post-transfusion.
                • Remove unit(s) from storage and complete the disposition portion of the
                  Issue/Transfusion Record (lab log) for each unit. Refer to Module 3 INV.010.
                • Remove the chart and/or blood bank copy of the tag from the unit. File or
                  discard, as applicable.
                • Discard or return units to inventory as per facility policy.

5.0 Reporting
        5.1 The chart copy of the type and screen and/or crossmatch report shall be sent to
            the appropriate ward to be placed on the patient’s health care record.
        5.2 The BTS laboratory copy of the report and worksheet shall be filed in accordance
            with the current edition of applicable standards.

6.0 Procedural Notes
        6.1 Autologous and directed units shall be used exclusively for the designated patient
            and shall not be crossed over into the allogeneic blood supply.



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                                                                                 Module	2	(Crossmatch)		•	MP.016
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                         MP.017		
                                   Specimen Referral


1.0 Principle
      To provide guidelines for packaging and referring specimens to a Blood Transfusion
      Service (BTS).

2.0 Scope and Related Policies
      2.1 BTS or CBS must be notified when a STAT request is being sent.
      2.2 Specimen(s) must be labelled according to MP.001.
          • Incorrectly or incompletely labelled specimens will not be tested.
      2.3 All specimens must be packaged according to Transportation of Dangerous
          Goods Guidelines.
      2.4 For traceability, each facility must have a system for recording and tracking
          referred out specimens.

3.0 Materials
      Completed appropriate requisition(s)
      Appropriate specimen(s)
      Appropriate shipping container(s)
      Completed shipping documentation, as applicable
      Donor unit segments (at least 2), as applicable

4.0 Procedure
      4.1 Determine priority.
      4.2 Determine method of transport, e.g., bus, family, air flight or courier, etc.
          and estimated time of arrival.
      4.3 Phone STAT requests to CBS or the BTS.
      4.4 For CBS requests, fax (CM 077) Fax Notification form, if applicable.
      4.5 Make a final check to ensure completed requisition and matching labelled
          specimen(s) are ready to ship.
      4.6 Complete specimen referral log.
      4.7 File the facility collection record.
      4.8 Package the specimen(s) and request form in appropriate container(s).
      4.9 Ship package(s) according to urgency.

5.0 Reporting
      N/A


Module	2	(Crossmatch)		•	MP.017
Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
6.0 Procedural Notes
        6.1 In crossmatch facilities that would not routinely refer out specimens, the
            ward and physician/authorized practitioner must be notified of any delay.




    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)




                                                                                 Module	2	(Crossmatch)		•	MP.017
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                        MP.018		
                Emergency Issue of Donor Red Cells Units


1.0 Principle
      To issue Group O unmatched donor red cell units in an emergency when time
      does not permit a type and screen/crossmatch.

2.0 Scope and Related Policies
      2.1 At minimum, Group O Rh positive should always be available for emergency
          use in all facilities where obstetrical care/dialysis is provided.
          2.1.1 The emergency unit(s) are stored in a separate clearly labelled box or area
                in the controlled blood bank refrigerator.
      2.2 A pre-transfusion blood specimen shall be drawn prior to the transfusion of
          unmatched Group O red cells whenever possible.
      2.3 Units must have a conspicuous label which clearly indicates that compatibility
          testing has not been completed.
      2.4 Emergency issue of unmatched Group O red cells will be given priority.
      2.5 Transfusion records must include a signed declaration by the requesting physician/
          authorized practitioner confirming that the clinical situation was sufficiently urgent
          to justify releasing blood products before completion of pre-transfusion testing.
      2.6 Should a red cell unit(s) be issued before compatibility testing is complete, and
          subsequently prove incompatible, the attending physician/authorized practitioner
          and the BTS Medical Director or designate shall be informed immediately.
          Transfusion of incompatible unit(s) shall be stopped immediately and transfusion
          of the unit(s) discontinued, pending the decision of the physician/authorized
          practitioner.

3.0 Materials
      Group O Rh positive or Rh negative donor red cell units
      Request form for crossmatch
      Patient specimen
      Tags (CM 106 or appropriate facility form)

4.0 Procedure
      4.1 Collect a specimen from the patient and send STAT to BTS laboratory.
          • It is preferable to collect the specimen prior to transfusion of the
            emergency blood.




Module	2	(Crossmatch)		•	MP.018
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
      4.2 Select appropriate emergency red cell units.
          4.2.1 When both Group O Rh positive and Group O Rh negative units are
                available select:
                • Group O Rh negative if the intended recipient is female less than or equal
                  to 45 years of age or a male less than or equal to 18 years of age.
                • Group O Rh positive if the intended recipient is female greater than
                  45 years of age or male greater than 18 years of age.
          4.2.2 When only Group O Rh positive units are available:
                • Notify the BTS.
                • The BTS will notify the BTS Medical Director or designate within 24 hours
                  if the recipient is determined to be Rh negative and is a female less than
                  or equal to 45 years of age, or a male less than or equal to 18 years of age.
                • Administration of Rh immune globulin will be determined by the
                  BTS Medical Director after consultation with the attending physician/
                  authorized practitioner. This consultation shall be documented by the BTS
                  Medical Director.
      4.3 Record the patient information on the tag, if available.
      4.4 Remove at least 2 segments from the unit(s) prior to issue for post-transfusion
          crossmatch.
          • Affix bar code label from the red cell unit to the segments.
          • Bag and store in controlled storage refrigerator.
      4.5 Issue the red cell units following the routine protocol.
      4.6 Complete the blood product Issue/Transfusion Record (lab log) with as much
          information as is available or becomes known.
      4.7 Send the following to the BTS as soon as possible:
          • pre-transfusion blood specimen;
          • completed request form;
          • 2 donor segments; and
          • A completed Blood Services copy of the tag from each unmatched donor unit
            transfused, where applicable.
      4.8 Complete the crossmatch as soon as possible (applicable to BTS only).
      4.9 Order replacement stock as soon as possible.
      4.10 File the Blood Bank copy of the tag.

5.0 Reporting
      N/A

6.0 Procedural Notes
      6.1 Use group specific crossmatch compatible red cells when the patient’s ABO has
          been determined.

                                                                      Module	2	(Crossmatch)		•	MP.018
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                    Version 2 • June 2007
   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	        	       	       												(Senior	Management)	     	       	       		(Senior	Management)
   	        	       	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	       	       									(Date	of	implementation)




Module	2	(Crossmatch)		•	MP.018
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                      MP.019		
               Issuing Donor Red Cells Prior to Completion
                        of Pre-Transfusion Testing


1.0 Principle
      To issue donor red cells, prior to completion of antibody screen once patient’s
      ABO/Rh testing is complete.

2.0 Scope and Related Policies
      2.1 In urgent situations, upon the physician’s/authorized practitioner’s request,
          ABO/Rh group specific red cells may be released prior to completion of antibody
          screen, once the patient’s ABO/Rh group has been determined.
      2.2 Before issue, the recipient’s plasma must be crossmatched against the donor
          cells (immediate spin crossmatch) to ensure detection of ABO incompatibility.
      2.3 The tag attached to the red cell unit and the patient requisition must indicate
          that compatibility testing was not complete at time of issue.

3.0 Materials
      ABO/Rh compatible donor red cells
      Request for Blood and Blood Components
      Patient specimen
      Red Cell Product Chart Copy (CM 102 or facility appropriate form)
      Released Prior to Completion of Testing Labels

4.0 Procedure
      4.1 Ensure the recipients ABO/Rh typing has been completed on a current specimen.
          Ensure current results match historical results, if applicable. If not, resolve
          discrepancy prior to the issuing of group-specific red cells
      4.2 Select ABO/Rh group-specific or group compatible donor units.
      4.3 Perform immediate spin crossmatch.
      4.4 Tag the donor red cell units with CM 102 (or appropriate facility tag)




Module	2	(Crossmatch)		•	MP.019
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
        4.5 Place a label similar to the following on each copy of the Red Cell Product Chart
            Copy (CM 102) and the requisition:

           Released Prior to Completion of Testing
           THIS AREA MUST BE COMPLETED BY REQUESTING PHYSICIAN/AUTHORIZED
           PRACTITIONER OR DESIGNATE
           I attest that the clinical situation is sufficiently urgent to warrant the transfusion
           of RED CELLS prior to completion of testing.
           Signature _______________________________
           Name PRINT______________________________

        4.6 Issue a preliminary patient report at time of issue and document clearly that
            compatibility testing was not complete at time of issue.
        4.7 Advise the ward that the physician/ authorized practitioner must complete
            the label on the Red Cell Product Chart Copy (CM 102).
        4.8 Complete the compatibility testing as soon as possible.
        4.9 If red cell units issued prior to completion of compatibility testing prove
            incompatible at any stage of testing and/or the antibody screen is positive,
            the attending physician/ authorized practitioner and the BTS Medical Director
            or designate must be informed immediately.

5.0 Reporting
        Issue a final report once testing is completed.

6.0 Procedural Notes
        N/A



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	         	     	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	     	       	        	        	        	
    Facility	effective	date:			__________________________________
    	         	     	       									(Date	of	implementation)




                                                                                 Module	2	(Crossmatch)		•	MP.019
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                       MP.020		
          Transfusion Reaction Investigation (Crossmatch)


1.0 Principle
      To investigate, document and report transfusion reactions to all blood, blood
      components and derivatives.

2.0 Scope and Related Policies
      2.1 The Blood Transfusion Service (BTS) shall have processes and procedures for
          the detection, evaluation, and reporting for suspected transfusion related
          adverse events.
          • If the blood bank is not staffed (e.g., outside normal working hours) then
            policies and procedures must be documented and in place to ensure that
            the requirements described in 4.2 and 4.2.1 are met.
      2.2 All transfusion reaction investigations are to be considered STAT.
      2.3 The transfusion reaction investigation shall be brought to the attention of the
          BTS Medical Director immediately according to procedure 4.6.
      2.4 All reactions (other than rash or urticaria) shall result in immediate cancellation
          of all indate crossmatched blood and/or type and screen specimens.
      2.5 The Adverse Event Reporting System (AERS) is a required component of these
          investigations by both nursing and blood bank laboratories.
      2.6 Nursing responsibility (refer to Manitoba Transfusion Medicine Best Practice
          Resource Manual for Nursing).

3.0 Materials
      Specimens:
      Pre-transfusion specimen
      Post-transfusion specimens:
      • Adults: 10-12 mL in EDTA tubes (correctly identified and labelled)
      • Pediatric: 3 mL in EDTA tube (correctly identified and labelled)
      • Urine – post transfusion reaction (where applicable)
      Donor Unit Segments
      Transfusion Reaction Investigation Form (CM105)
      Urinalysis requisition (where applicable)
      0.9% saline and IV infusion set
      Implicated blood, blood component and/or derivative and administration set




Module	2	(Crossmatch)		•	MP.020
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 11
4.0 Procedure
      If symptoms are rash and urticaria:
      1. No post-transfusion specimen collection is required
      2. Ensure completion of Transfusion Reaction Investigation Form (CM105)
      (refer to reporting)
      For all other reactions or progressed symptoms of rash and/or urticaria:
      4.1 Ensure a post-transfusion blood specimen is collected.
      4.2Perform a clerical check by re-checking patient and product information on the
         discontinued blood, blood component bag and/or derivative vial, product chart
         copy (tag) and any other units already infused (if available).
          4.2.1 If a clerical error is discovered:
                • Notify Charge Technologist and BTS Medical Director
                • Initiate a search of appropriate records to determine whether misidentification
                  or incorrect issue of components has put other patients at risk.
      4.3 Centrifuge the post-transfusion specimen and visually inspect plasma for hemolysis/icteric.
          • compare the color of the plasma of the post reaction specimen to that of the
            pre-transfusion specimen.
          • if a difficult collection is suspected have a second specimen drawn and repeat
            visual inspection.
          • if the specimen was drawn greater than 5 to 7 hours after the suspected
            reaction (refer to procedural note 6.1).
          • if a hemolytic reaction is suspected, the physician/authorized practitioner or BTS
            Medical Director may request a post-transfusion urine specimen be examined
            (refer to procedural note 6.2).
      4.4 Perform a direct antiglobulin test (DAT) on the post-transfusion EDTA specimen.
          • If post-reaction DAT is positive, perform DAT on pre-transfusion specimen.
            (refer to procedural note 6.3).
          • If post-reaction DAT is positive due to IgG, refer to CBS crossmatch lab for elution.
      4.5 Perform an ABO/Rh test on the post-transfusion EDTA specimen.
          • If the post-transfusion ABO/Rh differs from the pre-transfusion ABO/Rh
            notify the Charge Technologist or designate and BTS Medical Director.
      4.6 Notify the BTS Medical Director immediately when:
          • the patient has died
          • the reaction is suspected to be severe
          • the reaction is suspected to be hemolytic
          • the reaction is suspected to be TRALI
          • the reaction is suspected to be allergic and is more than just hives, e.g., asthma,
            bronchospasm, shock and hypotension




                                                                         Module	2	(Crossmatch)		•	MP.020
2 of 11 • Manitoba Transfusion Quality Manual for Blood Banks                      Version 2 • June 2007
          • any of the symptoms listed below are described on the requisition:
              -   pronounced blood pressure drop
              -   back pain
              -   respiratory distress
              -   wheezing
              -   anaphylaxis
              -   shock
              -   hemoglobinuria
      4.7 If the clerical check, hemolysis check, ABO/Rh check and DAT are all negative and
          there are no significant clinical indications that an acute hemolytic transfusion
          reaction has occurred as determined by the attending physician/authorized
          practitioner then there is no need for any further workup unless additional
          units are required for transfusion.
          • In this case, the post-transfusion reaction specimen can be used for the new
            crossmatch order.
      4.8 If any of the clerical checks or test results are positive or suspicious or if the
          patient’s clinical condition is suggestive of an hemolytic transfusion reaction the
          following testing should be initiated:
          • Repeat ABO and Rh testing on the pre-reaction specimen and on the donor
            unit(s) in question.
              - If results are not as expected, suspect a specimen mix up or mislabelling.
                Perform appropriate search to determine if another patient may be at risk.
          • Antibody screen on pre and post reaction specimens.
              - If a previously undetected antibody is discovered, perform antibody
                identification. Refer to MP.017 if antibody investigation is referred out.
              - If antibody is discovered only in the post specimen, suspect either an
                amnestic response or a passively acquired antibody from the blood, blood
                component or derivative (especially if a derivative such as IVIG has been
                transfused).
              - Any donor units transfused must be phenotyped for the corresponding
                antigen.
          • Crossmatch the implicated donor unit with the post-reaction specimen by the
            IAT technique.
              - If incompatible, repeat the crossmatch with the pre-transfusion specimen
                by IAT technique.
          • BTS Medical Director may ask for additional testing such as urinalysis
            (see procedural note 6.2), LD, Bilirubin, Haptoglobin and IgA levels.
      4.9 Examine the blood remaining in the unit and administrative tubing for evidence
          of hemolysis, especially if non-immune hemolytic transfusion reaction suspected.




Module	2	(Crossmatch)		•	MP.020
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 3 of 11
      4.10 If the reaction is febrile with a temperature increase of greater than 2oC,
           suspect bacterial sepsis:
          • perform bacterial cultures on patient
          • perform bacterial cultures on donor units (do not use segments)
      4.11 Record findings on Transfusion Reaction Investigation Form (CM105) which
           must be reviewed by the BTS Medical Director or Charge Technologist.

5.0 Reporting
      5.1 Reaction to Blood and Blood Components (CBS Crossmatch Lab) Refer
          to Process Flow A
          5.1.1 Review the Transfusion Reaction Investigation Form (CM105) and ensure
                it is complete.
          5.1.2 After completion of the investigation, send the following:
                • White “Blood Services” copy to the BTS Medical Director.
                • Green “Manitoba Health” copy to Manitoba Health’s Provincial Blood
                  Programs Coordinating Office.
          5.1.3 After review by the BTS Medical Director, the BTS sends the following
                copies of the completed and signed report and/or CM105 conclusions:
                • A copy of the report is retained by the BTS indefinitely.
                • A copy of the report is sent to the facility Blood Bank.
                • A copy of the CM105 conclusions (front and back) is sent to Manitoba
                  Health’s Provincial Blood Programs Coordinating Office.
      5.2 Reaction to Blood and Blood Components (DSM BTS/ Crossmatch Labs),
          refer to Process Flow B
          5.2.1 Review the Transfusion Reaction Investigation Form (CM105) and ensure
                it is complete.
          5.2.2 After completion of the investigation, send the following:
                • Green “Manitoba Health” copy and white “Blood Services” copy to
                  Manitoba Health’s Provincial Blood Programs Coordinating Office. Retain
                  a photocopy of both sides of the white “Blood Services” copy.
                • The pink “Blood Bank” copy to be filed in the facility blood bank where
                  the reaction originated.
                • “Chart” copy to be filed according to policies and procedures of the
                  facility where the reaction originated.
          5.2.3 Once the BTS Medical Director’s conclusion are received:
                • A copy of the report is retained in the BTS indefinitely.
                • A copy of the report is sent to the facility blood bank where the reaction
                  originated or the patient’s chart as applicable.




                                                                       Module	2	(Crossmatch)		•	MP.020
4 of 11 • Manitoba Transfusion Quality Manual for Blood Banks                    Version 2 • June 2007
      5.3 Reaction to a Derivative (All BTS labs) refer to Process Flow C
          5.3.1 Review the Transfusion Reaction Investigation Form (CM105) and ensure
                it is complete.
          5.3.2 Retain the following:
                • “Chart” copy to be filed according to facility policies and procedures.
                • Pink “Blood Bank” copy to be retained indefinitely.
                NOTE: if the reaction to the derivative did not originate at your facility,
                these copies will be retained at the facility where the reaction occurred.
          5.3.3 Send the following:
                • Green “Manitoba Health” copy and white “Blood Services” copy to
                  Canadian Blood Services Winnipeg Centre’s Crossmatch Lab.
          5.3.4 Upon receipt of the conclusions (CM105 and manufacturer’s),
                • A copy of the report is placed on the patient’s chart.
                • A copy is retained by the BTS indefinitely.
                NOTE: if the reaction to the derivative did not originate at your facility
                you will not receive a copy of the conclusions.

6.0 Procedural Notes
      6.1If the post-transfusion specimen is not drawn until 5-7 hours after an episode of
          acute hemolysis, hemoglobin degradation products, especially bilirubin, may be
          in the bloodstream and cause yellow or brown discoloration. Rising bilirubin may
          begin as early as one hour post-reaction, peak at 5-7 hours and disappear within
          24 hours if liver function normal.
      6.2 The post-transfusion urine may be examined for hemoglobinuria. In acute
          hemolytic transfusion reactions, free hemoglobin released from damaged cells
          can cross the renal glomeruli and enter the urine (hematuria and myoglobinuria
          would not be expected).
          Urine examination should be done on the supernatant fluid after centrifugation
          of freshly collected specimen.
          Misleading results can occur if previously intact red cells undergo in vitro lysis
          during transportation or storage.
      6.3 If transfused incompatible cells have been coated with antibody but not
          immediately destroyed, the post-reaction specimen DAT is likely to be positive,
          often with a mixed field agglutination pattern. If the transfused cells have been
          rapidly destroyed, the post-transfusion DAT may be negative if there has been
          a delay in collection of the post-transfusion specimen. Non-immune hemolysis
          (e.g., overheating or freezing of the unit) causes hemoglobinuria but not a
          positive DAT.
      6.4 If blood in the administration tubing is hemolyzed and the blood in the unit is
          not, a faulty infusion device may be the cause. If the blood in both the unit and
          the administration set is hemolyzed, suspect a physically hemolyzed unit or the
          addition of a solution to the container that destroyed the cells.

Module	2	(Crossmatch)		•	MP.020
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks •  of 11
      6.5 If symptoms and/or clinical presentation are suggestive of TRALI, the BTS Medical
          Director will notify the CBS Medical Director to initiate investigation (test donor
          plasma for HLA antibodies).
      6.6 See table for reactions




       * Technical Resource Mnaual (TraQ). British Columbia Provincial Blood Coordinating Office. April 2000.




                                                                                         Module	2	(Crossmatch)		•	MP.020
 of 11 • Manitoba Transfusion Quality Manual for Blood Banks                                      Version 2 • June 2007
   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	        __________________________________
   	        	       	       												(Senior	Management)	      	       	       		(Senior	Management)
   	        	       	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	       	       									(Date	of	implementation)




Module	2	(Crossmatch)		•	MP.020
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks •  of 11
Nursing Process
Manitoba	Adverse	Transfusion	Reaction	Reporting	System

                                                  Transfusion
                                                    Reaction

1
        Nursing/Health Care Professional notifies Attending Physician/*Authorized Practitioner
        immediately! Refer to the ‘Transfusion Reactions Algorithm’
        & facility policies and procedures


2
       Is this a serious reaction? A serious reaction…
       1. Requires medical intervention directly attributable to the event; or
       2. Results in persistent or significant disability or incapacity; or
       3. Necessitates medical intervention to preclude permanent damage
           or impairment of a body function; or
       4. Is life threatening or results in death.
       If this is NOT a serious reaction go directly to box 5 below.



3
        Attending Physician/*Authorized Practitioner notifies BTS Medical
        Director immediately!


4       BTS Medical Director notifies CBS Medical Director (Winnipeg) immediately!              CBS Medical Director
                                                                                                notifies Health Canada

5
       Nursing/Health Care Professional:
       • completes “Transfusion Reaction Investigation Form” CM105 and forwards to Blood Bank.


6
       Blood Bank (or Blood Transfusion Service (BTS) acting as the Blood Bank):
       Will follow Processes A, B, or C depending on the facilities and the type of product
       implicated in the transfusion reaction.


*Authorized Practitioner defined in Manitoba Transfusion Medicine Best Practice Resource Manual for Nursing




                                                                                        Module	2	(Crossmatch)		•	MP.020
8 of 11 • Manitoba Transfusion Quality Manual for Blood Banks                                     Version 2 • June 2007
Process A
Manitoba	Adverse	Transfusion	Reaction	Reporting	System
Where CBS is the Blood
Transfusion Service                               Transfusion
(Crossmatch Laboratory)                             Reaction

 1       Nursing/Health Care Professional notifies Attending Physician/*Authorized Practitioner
       immediately! Refer to the ‘Transfusion Reactions Algorithm’ and facility policies and procedures


 2      Is this a serious reaction? A serious reaction…
        1. Requires medical intervention directly attributable to the event; or
        2. Results in persistent or significant disability or incapacity; or
        3. Necessitates medical intervention to preclude permanent damage
            or impairment of a body function; or
        4. Is life threatening or results in death.
        If this is NOT a serious reaction go directly to box 5 below.



 3      Attending Physician/*Authorized Practitioner notifies BTS Medical Director immediately!

 4                                                                                               CBS Medical Director
        BTS Medical Director notifies CBS Medical Director (Winnipeg) immediately!
                                                                                                 notifies Health Canada

 5
        Nursing/Health Care Professional:
        • completes “Transfusion Reaction Investigation Form” CM105 and forwards to Blood Bank.


 6
        Blood Bank (or Blood Transfusion Service (BTS) acting
        as the Blood Bank):
                                                                                                Patient’s chart
        • verifies and completes CM105 and forwards to BTS for
         investigation and retains CM105 “Pink” copy
        • Retains a copy of conclusions and sends a copy to patient’s chart
                                                                                                Public Health
                                                                                                Agency of Canada
 7      CBS Winnipeg (acting as the BTS):                                                       (PHAC)
        • performs investigation
        • sends CM105 “Green” copy to MB Health
        • CBS\BTS Medical Director completes conclusions                                                Legend
        • sends conclusions to facility Blood Bank and MB Health

 8      MB Health (Provincial Blood Programs
                                                                                                       Investigation

        Coordinating Office):
        • enters and analyses data                                                                      Conclusions
        • sends anonymized subset to PHAC quarterly

*Authorized Practitioner defined in Manitoba Transfusion Medicine Best Practice Resource Manual for Nursing

Module	2	(Crossmatch)		•	MP.020
Version 2 • June 2007                                    Manitoba Transfusion Quality Manual for Blood Banks •  of 11
Process B
Manitoba	Adverse	Transfusion	Reaction	Reporting	System
Where a DSM Blood
Transfusion Service is the
                                                 Transfusion
Crossmatch Laboratory                              Reaction

1
        Nursing/Health Care Professional notifies Attending Physician/*Authorized Practitioner immediately!
        Refer to the ‘Transfusion Reactions Algorithm’ and facility policies and procedures


2
       Is this a serious reaction? A serious reaction…
       1. Requires medical intervention directly attributable to the event; or
       2. Results in persistent or significant disability or incapacity; or
       3. Necessitates medical intervention to preclude permanent damage
           or impairment of a body function; or
       4. Is life threatening or results in death.
       If this is NOT a serious reaction go directly to box 5 below.



3
        Attending Physician/*Authorized Practitioner notifies BTS Medical Director immediately!

4                                                                                                CBS Medical Director
        BTS Medical Director notifies CBS Medical Director (Winnipeg) immediately!               notifies Health Canada

5      Nursing/Health Care Professional:
       • completes “Transfusion Reaction Investigation Form” CM105 and forwards to Blood Bank.


6      Blood Bank (or Blood Transfusion Service (BTS)                                              Patient’s chart
       acting as the Blood Bank):
       • verifies and completes CM105 and forwards to BTS
       for investigation and retains CM105 “Pink” copy
       • Retains a copy of conclusions and sends a copy to patient’s chart                              Legend

7      DSM BTS:
                                                                                                       Investigation
       • performs investigation
       • sends CM105 “Green” and “White” pages to MB Health                                            Conclusions
       (retain a photocopy of both sides of the ‘White’)
       • Retains a copy of conclusions and sends copy to reporting
       facility Blood Bank or to patient’s chart as applicable
                                                                                             9
                                                                                                 DSM Medical
8      MB Health (Provincial Blood Programs
                                                                                                 Director: completes
                                                                                                 conclusions & returns
       Coordinating Office):                                                                     to MB Health
       • forwards CM105 to DSM Medical Director
       • returns conclusions to BTS with DSM Medical Director’s conclusions
       • enters and analyses data                                                              Public Health Agency
       • sends anonymized subset to PHAC quarterly                                             of Canada (PHAC)

*Authorized Practitioner defined in Manitoba Transfusion Medicine Best Practice Resource Manual for Nursing
                                                                                        Module	2	(Crossmatch)		•	MP.020
10 of 11 • Manitoba Transfusion Quality Manual for Blood Banks                                    Version 2 • June 2007
Process C
Manitoba	Adverse	Transfusion	Reaction	Reporting	System
For Derivatives                                   Transfusion
                                                    Reaction
1
        Nursing/Health Care Professional notifies Attending Physician/*Authorized Practitioner immediately!
        Refer to the ‘Transfusion Reactions Algorithm’ and facility policies and procedures

 2
        Is this a serious reaction? A serious reaction…
        1. Requires medical intervention directly attributable to the event; or
        2. Results in persistent or significant disability or incapacity; or
        3. Necessitates medical intervention to preclude permanent damage
            or impairment of a body function; or
        4. Is life threatening or results in death.
        If this is NOT a serious reaction go directly to box 5 below.

 3      Attending Physician/*Authorized Practitioner notifies BTS Medical Director immediately!


 4      BTS Medical Director notifies CBS Medical Director (Winnipeg) immediately!


 5      Nursing/Health Care Professional:
        • completes “Transfusion Reaction Investigation Form” CM105 and forwards to Blood Bank.


 6      Blood Bank (or Blood Transfusion Service (BTS)                                           Patient’s chart
        acting as the Blood Bank):
        • verifies and completes CM105 and forwards to BTS
          for investigation and retains CM105 “Pink” copy
        • Retains a copy of conclusions and sends a copy to patient’s chart                                     Legend

 7                                      8                                                                      Investigation
       BTS: forwards CM105                   CBS Crossmatch Lab:
                                                                                                               Conclusions
       “Green” and back                      forwards CM105 “Green”
       “White” pages to CBS                  and back “White” pages                                           Manufacturer’s
       Crossmatch Lab                        to CBS Medical Director.                                          Conclusions


                                                                                             Attending Physician
 9     CBS Medical Director:
       • notifies Manufacturer and CBS Head Office
       • completes back of CM105
       • sends CM105 “Green” page and copy of conclusions to MB Health                         CBS Head Office
       • sends CM105 conclusions to reporting Blood Bank
         or BTS as applicable
       • sends manufacturer’s conclusions to Attending Physician                             Manufacturer
         and to reporting Blood Bank or BTS as applicable                                    Investigation and Results



     Public Health Agency         10    MB Health
                                        • enters and analyses data                              Health Canada
      of Canada (PHAC)                  • sends anonymized subset to PHAC quarterly
*Authorized Practitioner defined in Manitoba Transfusion Medicine Best Practice Resource Manual for Nursing
Module	2	(Crossmatch)		•	MP.020
Version 2 • June 2007                                  Manitoba Transfusion Quality Manual for Blood Banks • 11 of 11
Module 3




           Module 3
                      Module	3:	Inventory	Management
                                           Table of Contents
    Blood, Blood Component and Derivative Inventory Management .................INV.001
    Storage of Blood, Blood Components and Derivatives ...................................INV.002
    Ordering Blood, Blood Components and Derivatives ......................................INV.003
    Receiving Blood, Blood Components and Derivatives ....................................INV.004
    Visual Inspection of Blood, Blood Components and Derivatives ..................INV.005
    ABO/Rh Confirmation Testing: Red Cell Units (Crossmatch Facilities) .......INV.006
    Issuing, Returning and Documenting Final Disposition
    of Blood, Blood Components and Derivatives ..................................................INV.007
    Transport of Blood, Blood Components and Derivatives
    (Within the Facility)...............................................................................................INV.008
    Inter-facility Shipping of Blood, Blood Components or Derivatives .............INV.009
    Documenting the Final Disposition of Returned
    or Discarded Blood, Blood Components and Derivatives ...............................INV.010
    Selection of Blood and Blood Components for Transfusion..........................INV.011
    Thawing Frozen Plasma Components................................................................INV.012
    Tagging Blood, Blood Components and Derivatives ........................................INV.013
    Tagging Divided Red Cells Units for Neonatal Protocol ...............................INV.013.1




Module	3	•	Table	of	Contents
Version 2 • June 2007                                       Manitoba Transfusion Quality Manual for Blood Banks
                                       INV.001		
                        Blood and Blood Component and
                        Derivative Inventory Management


1.0 Principle
      To optimize blood, blood component and derivative inventory management
      practices.

2.0 Scope and Related Policies
      2.1 Blood Transfusion Service (BTS)/blood bank inventory levels should provide
          adequate supplies of blood, blood components and derivatives for routine
          and emergency situations with minimal outdating.
      2.2 Optimal inventory levels should be evaluated by the BTS/blood bank and adjusted
          according to facility policy.

3.0 Materials
      N/A

4.0 Procedure
      4.1 Procedure to Establish Inventory Levels
          4.1.1 Determine optimal facility inventory levels for blood, blood components
                and derivatives.
            a) Review outdating rates for all blood, blood components and derivatives.
            b) Review inventory levels when changes in facility services may affect
               inventory requirements.
                For example:
                • Addition or closure of beds
                • Addition or closure of operating rooms
                • Introduction of new surgical procedures
                • Change in transfusion/infusion practices affecting blood, blood
                  components and derivatives usage, e.g., oncology, transplantation,
                  neonatology, cardiac surgery.
                • Addition or change in surgeons and/or anaesthetists
                • Type of facility affiliations and outreach programs




Module	3	•	INV.001
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          c)    Calculate statistics for weekly usage of blood, blood components and
                derivatives.
                • Compile weekly issues, by blood type if applicable, for a minimum of
                  6 months (either prospectively or retrospectively)
                • Determine average weekly usage of each blood and blood component
                  by dividing the total use of each ABO type (if applicable) by the number
                  of weeks in the period covered
                • Determine the minimum inventory level by multiplying the weekly
                  average by the number of desired weeks supply (take into consideration
                  the distance from the blood supplier, transportation mode and any other
                  unique local factors).
                • Add an emergency level of red cell units and plasma, e.g., 6 units of
                  Group O red cells and 4 units of Group AB plasma if the facility has
                  trauma services or services that require large numbers of blood and
                  blood components.
          4.1.2 Post minimum and maximum inventory levels for easy reference.
      4.2 Procedure to Optimize Inventory Management
          4.2.1 Review inventory daily or more frequently when actively bleeding patients
                are being treated.
          4.2.2 Order blood, blood components and derivatives from the blood supplier
                based on optimal inventory levels. Refer to INV.003
          4.2.3 Return short-dated (7 to 10 days remaining shelf life) emergency red cell
                units to CBS to reduce wastage as per arrangement with blood supplier,
                as applicable.
          4.2.4 Select oldest units first for transfusion whenever possible.
                • Ensure there is a clear communication system to alert staff of short-dated
                  red cell units, blood components or derivatives.
          4.2.5 Ensure clear, consistent communication with the blood supplier.
                • Notify blood supplier when patients are being transfused/infused large
                  quantities of blood, blood components and derivatives.
                • Clearly indicate when orders are required STAT.
          4.2.6 Notify key personnel, according to facility protocol, during critical blood,
                blood component and derivative shortages.

5.0 Reporting
      N/A

6.0 Procedural Notes
      N/A




                                                                                  Module	3	•	INV.001
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                   Version 2 • June 2007
   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	        	       	       												(Senior	Management)	     	       	       		(Senior	Management)
   	        	       	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	       	       									(Date	of	implementation)




Module	3	•	INV.001
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                      INV.002		
      Storage of Blood, Blood Components and Derivatives


1.0 Principle
      To store blood, blood components and derivatives appropriately.

2.0 Scope and Related Policies
      2.1 Blood, blood components and derivatives shall be stored in approved storage
          equipment that prevents damage and limits deterioration..
      2.2 Ultra-low temperature freezers (i.e., -70°C) shall not be used for storage of
          plasma and cryoprecipitate AHF.
      2.3 Autologous and directed red cell products must be stored in a segregated area
          from homologous products.

3.0 Materials
      N/A

4.0 Procedure
      4.1 Store blood, blood components and derivatives by expiration date and at
          appropriate storage temperatures, refer to Table 1.
      4.2 Organize blood, blood components and derivatives in the appropriate storage
          equipment in a manner that identifies and segregates:
          Emergency product
          Crossmatched product
          Uncrossmatched product according to ABO/Rh
          Autologous and directed product
          Quarantined product
          Derivatives




Module	3	•	INV.002
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
Table 1: Blood, Blood Component and Derivative Storage Conditions
 Blood Product                Approximate Volume Storage Temp.                        Shelf Life
 AS-3 RBC LR                  240 to 340 mL               1 to 6 °C                   42 days

 Whole Blood CPDA-1 LR 240 to 340 mL                      1 to 6 °C                   35 days
 (Autologous donors)
 Washed RBC LR                200 mL                      1 to 6 °C                   24 hours
 Frozen RBC LR                200 mL                      Thawed: 1 to 6 °C           24 hours
 Irradiated RBC (AS-3)        240 to 340 mL               1 to 6 °C                   28 days from date of
                                                                                      irradiation or 42 days
                                                                                      from donation date,
                                                                                      whichever comes first
 Fresh Frozen Plasma LR       200 mL                      Frozen: -18°C:              Frozen: 1 year
                                                          1 to 6 °C Thawed            Thawed: 24 hours
 Fresh Frozen Plasma,         500 mL                      Frozen: -18°C               Frozen: 1 year
 Apheresis                                                Thawed: 1 to 6 °C           Thawed: 24 hours
 Cryosupernatant              200 mL                      Frozen: -18°C               Frozen: 1 year
 Plasma                                                   Thawed: 1 to 6 °C           Thawed: 24 hours
 Platelets, Random            40 to 70 mL                 Continuous agitation/        5 days
 Donor LR                     55x109 platelets            single layer at: 20 to 24 °C Pooled: 24 hours
 Platelets, Single Donor,     300 mL                      Continuous agitation/        5 days
 Apheresis                    300 x109 platelets          single layer at: 20 to 24 °C
 Cryoprecipitate AHF LR       5 to 15 mL                  Frozen: -18°C               Frozen: 1 year
                              greater than 80 units       Thawed: 20 to 24 °C         Thawed: 6 hours
                              FVIII(FVIII:C)                                          Pooled: 4 hours

                              150 mg fibrinogen
 Derivatives                  Dosage depends on           Storage temperature         Varies. Refer to
                              product                     depends on product          expiration date on
                                                                                      product
 Derivatives –                Volume depends              Storage temperature         1 to 6 °C: 24 hours
 Reconstituted or             on product                  depends on product          after seal is broken
 pooled.                                                                              20 to 24 °C: 4 hours
                                                                                      after seal is broken


5.0 Reporting
      N/A

6.0 Procedural Notes
      N/A




                                                                                           Module	3	•	INV.002
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                            Version 2 • June 2007
   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	        	       	       												(Senior	Management)	     	       	       		(Senior	Management)
   	        	       	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	       	       									(Date	of	implementation)




Module	3	•	INV.002
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                          INV.003		
       Ordering Blood, Blood Components and Derivatives


1.0 Principle
      To order blood, blood components and derivatives into inventory.

2.0 Scope and Related Policies
      Blood, blood components and derivatives shall be ordered to maintain facility
      established inventory levels.

3.0 Materials
      CBS Blood Component Order Form (F040547). Refer to Forms Section
      CBS Plasma Proteins Order Form (1000103464). Refer to Forms Section
      CBS Special Request Order Form (1000103465)
      Manitoba Health Biologics/Vaccine Order Form

4.0 Procedure
      4.1 Weekdays:
          4.1.1 Order blood, blood components and derivatives as needed in order to
                maintain inventory levels.
          4.1.2 Place the order to the supplier as soon as is possible on the day of ordering.
                • STAT orders can be placed at any time.
                • Additional routine orders can be placed at any time, however, try to
                  consolidate orders whenever possible.
          4.1.3 Before placing the order:
                • Ensure all cancelled blood, blood components and derivatives are returned
                  to the available inventory if applicable.
                • Account for short-dated products that will be discarded or shipped for
                  redistribution if applicable.
                • Check if receiving any products from other facilities.
          4.1.4 Determine the amount and type of blood, blood component and derivative
                to order:
                • Count all products in stock.
                • Subtract the number counted from the maximum inventory number for
                  each specific product.
                • Order the difference.
                • Refer to Table 1



Module	3	•	INV.003
Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks • 1 of 4
          4.1.5 Complete the appropriate order form. For CBS orders, indicate special
                requirements in the Special Request area:
                • Phenotyped red cells
                • Divided red cells
                • Divided FFP
                • Special Access Programme (SAP) derivative
          4.1.6 If ordering platelets, indicate the date they are to be transfused.
          4.1.7 Indicate the priority of order and method of shipment.
          4.1.8 Fax the order to the supplier. STAT orders must also be phoned to
                the supplier.
          4.1.9 Retain and post the order form in a designated area until the products
                are received.
              • Contact supplier if order is not received when expected.
          4.1.10 Communicate blood supplier shortages of a specific product or ABO group
                 or Rh type:
                • Record as concern or critical on a communication board or in a
                  communication book.
                • Notify other technologists on the shift as well as technologists on the
                  following shifts.
                • If the shortage is extreme, notify appropriate facility personnel.
                  Refer to facility policies and procedures
                • If necessary, surgeries and routine transfusions/infusions may have to
                  be cancelled.
      4.2 Weekends, Evening/Night Shifts, and Statutory Holidays:
          4.2.1 Place only STAT orders. Follow ordering triggers as per Table 1.
          4.2.2 Complete the appropriate order form. Indicate the STAT priority.
          4.2.3 Fax the order and phone the supplier.
          4.2.4 Retain and post the order form in a designated area until the products
                are received.
                • Contact supplier if order is not received when expected.
      4.3 Special Order
          4.3.1 IgA-deficient red cells, platelets or plasma requires consultation with CBS.
          4.3.2 Some derivatives are not licensed for use in Canada and therefore require a
                number from the Health Canada Special Access Programme (SAP). Contact
                CBS and follow instructions.
      4.4 Miscellaneous Items Order
          Refer to facility specific list
                • Universal infusion sets (for Albumin and IVIG)

                                                                                  Module	3	•	INV.003
2 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                   Version 2 • June 2007
5.0 Reporting
      N/A

6.0 Procedural Notes
Table 1: Blood, Blood Component and Derivative Inventory Levels
 Red Cells
 ABO                    Rh                       Maximum Inventory Order Trigger
                                                 Level 1           Level 2
 O                      Pos
 A                      Pos
 B                      Pos
 AB                     Pos
 O                      Neg
 A                      Neg
 B                 Neg                          Order as needed               Order as needed
 AB                Neg                          Order as needed               Order as needed
 Platelets, Plasma, Cryoprecipitate            AHF
 ABO               FFP                          Platelets                     Cryo
 O                                              Order as needed               Order as needed
 A
 B
 AB
 Derivatives
 Product                                         Inventory Stock
 Albumin 5% 250 mL
 Albumin 25% 100 mL
 RhIG (WinRho®) 120 μg
 RhIG (WinRho®) 300 μg
 IVIG 20g, 10g, 5g, 2.5g                         Order as needed
 ISG 2 mL
 HBIG 5 mL                                       Order as needed
 HBIG 0.5 mL (for babies)                        Order as needed
 HBV (for babies)                                Order as needed
 Factor VIII
 Factor IX                                       Order as needed
 Pentaspan 250 mL
 Pentaspan 500 mL

1 Order up to maximum inventory level: stock blood product to this level.
2 Order trigger level: place an order to blood supplier when stock is at this number.

Module	3	•	INV.003
Version 2 • June 2007                               Manitoba Transfusion Quality Manual for Blood Banks • 3 of 4
    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)




                                                                                              Module	3	•	INV.003
4 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                          INV.004		
      Receiving Blood, Blood Components and Derivatives


1.0 Principle
      To receive blood, blood components and derivatives into inventory. This includes
      blood, blood components and derivatives that were received from the blood
      supplier, via inter-facility exchange or shipped with a patient.
      To provide an accurate record of the receipt of blood, blood components
      or derivatives.

2.0 Scope and Related Policies
      2.1 Blood, blood components or derivatives shall be handled, stored, distributed,
          and shipped in a manner that prevents damage and limits deterioration.
      2.2 A process shall be in place to ensure the traceability of all blood, blood
          components or derivatives received.
      2.3 A process shall be in place to ensure that segments from all transfused units
          are removed and stored at 1 to 6°C for at least 7 days after transfusion.

3.0 Materials
      Packing slip(s)
      Issue/Transfusion Record (lab log)
      Forms, as applicable:
      Inter-facility Blood, Blood Component and Derivative Transfer Form (FormINV.002),
         refer to Forms Section
      Product tag(s)
      Blood Bank Customer Feedback Form (FormINV.003) refer to Forms Section
      Occurrence report
      Patient history card

4.0 Procedure
      4.1 Receiving Blood and Blood Components
          4.1.1Ensure there is a security seal on the belt surrounding the shipping box.
                • If a security seal is not present:
                    • If shipped directly from a blood bank, BTS or the blood supplier, contact
                      the shipper immediately and investigate. Refer to procedural note 6.1
                      and 6.4.
                    • If the box was transported with a patient and there is no
                      documentation indicating the box was open en route by authorized
                      personnel, then contact the shipper immediately and investigate. Refer
                      to procedural note 6.2.


Module	3	•	INV.004
Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks • 1 of 
          4.1.2 Determine the time from packing to unpacking of the shipment.
                • The time and date of packing for transport is recorded on the shipping box
                  label, packing slip(s) and FormINV.002.
                • Verify and document that the time from packing to unpacking is less than
                  24 hours.
          4.1.3 Open the shipping container(s) one at a time and:
                4.1.3.1 Inspect the packing of the blood and blood components inside.
                       • Retrieve the packing slip(s) and FormINV.002, if applicable.
                       • Ensure the paperwork is for the correct facility.
                       • Initial and write the time and date of unpacking on the form(s).
                       • If packed correctly, document by checking off the appropriate box on
                         FormINV.002, if applicable.
                       • If not packed correctly, notify the shipper of the error and complete
                         FormINV.003
                       • Quarantine until the incident is reviewed. Refer to procedural
                         note 6.1.1.
                4.1.3.2 Inspect the contents of the plastic bag.
                       • If there is liquid in the bag, determine whether any of the shipped
                         blood or blood components are broken. If some of the contents
                         are broken, refer to procedural note 6.1.2.
          4.1.4 Remove the blood and blood components from the plastic bag.
                4.1.4.1 Account for all units in the shipment.
                4.1.4.2 Verify the information on the blood component label and tag
                        (if applicable), with the information on the packing slip and
                        FormINV.002.
                        • If the information matches, place a check mark beside the
                          corresponding unit on the packing slip.
                        • If there are any discrepancies, document on the packing slip. Notify
                          the shipper.
          4.1.5 Visually inspect each unit.
          4.1.6 Confirm that request(s) for special blood or blood components/testing were
                received from the blood supplier, if applicable.
                • Special blood and blood components (as noted below) will have the special
                  attribute(s) labelled on the blood or blood component.
                • Place a check mark beside the applicable special product on the packing
                  slip to confirm the labelled unit.
                    - Irradiated
                    - Anti-CMV negative
                    - Phenotyped unit(s). Refer to procedural note 6.3.

                                                                                  Module	3	•	INV.004
2 of  • Manitoba Transfusion Quality Manual for Blood Banks                   Version 2 • June 2007
          4.1.7 Store blood and blood components at the appropriate storage temperature.
                • Store blood and blood components by expiration date, to ensure that the
                  oldest components will be selected first.
                NOTE: When receiving inter-facility transfers of blood or blood components
                place in appropriate storage or discard as per facility policy.
          4.1.8 Document receipt of all blood and blood components in the Issue/
                Transfusion Record (lab log), as per facility policy.
                NOTE: When receiving, ensure name of shipping facility is documented.
          4.1.9 Remove and retain 2 segments from each of the red cell units upon receipt
                or prior to transfusion, as per facility policy.
                • Segments must be stored in a controlled refrigerator for 7 days post-transfusion.
                • For emergency units retain 2 to 4 segments upon receipt and keep for
                  7 days past expiration.
          4.1.10 In crossmatch facilities only, quarantine units in the blood bank refrigerator
                 until the ABO /Rh has been confirmed.
          4.1.11 Retain a copy of the packing slip(s) and FormINV.002 indefinitely.
          4.1.12 Store shipping container(s) in an appropriate location or return to blood
                 supplier as per established procedure(s). Close all container(s) and re-attach
                 closure belts. Remove shipping label(s) from the container(s).
      4.2 Receiving Derivatives
          4.2.1 Refer to ‘Receiving Blood and Blood Components’ (above) and complete
                all applicable steps with the following additional information:
                • Verify the lot number(s) and quantity (number of bottles/vials) received
                  with the information on the packing slip and FormINV.002.
                • Patient demographics on derivatives from the Special Access Programme
                  (SAP) will be printed on the packing slip.
                • Sign and date both copies of the packing slip and initial FormINV.002
                  in the appropriate area.
                • Send a copy of the packing slip to the blood supplier.
          4.2.2 If receiving patient specific derivatives:
                • Prepare and attach a tag to the derivative container(s).
      4.3 Receiving Autologous/Directed Red Cell Components
          4.3.1 Refer to ‘Receiving Blood and Blood Components’ and complete all
                applicable steps with the following additional information:
                • Verify the unit number(s) with the information on the packing slip and
                  FormINV.002, and the autologous/directed form.
                • Verify that the patient’s name, birth date, and PHIN or unique identifier
                  on the autologous/directed tag attached to the unit(s) is identical to
                  the information on the autologous/directed form and the packing slip
                • Verify the patient’s name printed on the blood bag label.
Module	3	•	INV.004
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          4.3.2 Ensure units are labelled “For Autologous Use Only”.
          4.3.3 Store autologous/directed blood and blood components in a designated
                area for autologous/directed donations.

5.0 Reporting
      5.1 Return or fax one copy of each packing slip and FormINV.002 to the blood
          supplier, where applicable. Retain the other copy in the facility blood bank
          or BTS indefinitely.
      5.2 For any discrepancies, packing errors, or if shipment was in transit more than
          24 hours:
          Complete an occurrence report, as per facility policy and FormINV.003.
          Document shipper notification on the packing slip.
      5.3 Document the receipt of blood, blood components or derivatives in the
          applicable Issue/Transfusion Record (lab log).
          In addition, record the manufacturer and the brand name for derivatives

6.0 Procedural Notes
      6.1 The attending physician/authorized practitioner must be notified immediately in
          the case of blood, blood components or derivatives that are deemed unsuitable
          and/or unusable:
          6.1.1 Unsuitable for use (as per facility protocol) should be:
                • documented as received, and
                • quarantined while investigated, then
                • discarded or returned to the blood supplier as appropriate (after
                  investigation and consultation).
                NOTE: If there are extenuating circumstances, quarantine the product and
                consult with supervisor for further direction. Blood, blood components or
                derivatives that do not meet receiving requirements must be authorized
                for use by the BTS Medical Director or designate. This authorization must
                be documented on the packing slip, FormINV.002 and the Issue/Transfusion
                Record (lab log).
          6.1.2 If unusable, document the reason for discard on the packing slip,
                FormINV.002 and the Issue/Transfusion Record (lab log).
      6.2 If units were transfused to a patient en route, the transfusion information should
          be recorded on FormINV.002.
          • If units are documented as sent but not received and disposition was not
            recorded on FormINV.002, then an investigation must be done to determine
            if the unit(s) were transfused.
          • If information cannot be obtained, the units should be considered “presumed”
            transfused.



                                                                                Module	3	•	INV.004
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       6.3 When phenotyped unit(s) are received:
          • If the phenotype tag indicates the blood supplier has confirmed the testing
            for the antigen(s), the donor phenotype does not require confirmation by the
            receiving BTS.
          • If the phenotype tag indicates the blood supplier has not confirmed the testing
            for the antigen(s), the donor phenotypes must be tested by the receiving BTS.
          • If the receiving BTS does not have the capability of testing for the phenotype,
            confirmed phenotypes must be ordered from the blood supplier.
       6.4 When blood and blood components are received without an intact security seal
           the shipper may recommend the following:
       1) If shipped by a public transport system such as a Greyhound bus, airline, or taxi,
          discard the product and immediately notify the attending physician/authorized
          practitioner to determine whether or not to re-order blood, blood components
          or derivatives.
       2) If shipped by a designated facility transport such as ambulance, facility/family
          member, the BTS Medical Director may consider authorizing the release of
          the product.




   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	        	       	       												(Senior	Management)	     	       	       		(Senior	Management)
   	        	       	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	       	       									(Date	of	implementation)




Module	3	•	INV.004
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks •  of 
                                        INV.005		
Visual Inspection of Blood, Blood Components and Derivatives


1.0 Principle
      To ensure that all blood, blood components and/or derivatives received, issued for transfusion,
      returned to inventory or shipped out of the facility are visually inspected for abnormalities.

2.0 Scope and Related Policies
      2.1 Blood, blood components and derivatives shall be visually inspected.
      2.2 The visual inspection shall be documented.
      2.3 If an abnormality or discrepancy is detected, the blood, blood component and/or
          derivative must be quarantined until appropriate disposition is determined.

3.0 Materials
      Blood, blood component and/or derivative
      Blood Bank Customer Feedback Form (Form INV.003), refer to Forms Section
      Appropriate Issue/Transfusion Record (lab log)

4.0 Procedure
      4.1 Inspect blood, blood components and/or derivatives at the following times:
          • Upon receipt from the blood supplier or another facility
          • At time of crossmatch
          • Before being issued for transfusion/infusion
          • Before being shipped to another facility
          • Upon return to usable inventory
      4.2 Determine if the blood, blood component and/or derivative is indate.
          • If the expiry date is day/month/year, the product expires at midnight on that day
          • If the expiry date is month/year, the product expires at midnight on the last day
            of the month
      4.3 Visually inspect the blood, blood component and/or derivative for abnormalities.
          Refer to the following Tables for inspection criteria:
          • Table 1: Visual Inspection of Red Cell /Whole Blood Components
          • Table 2: Visual Inspection of Platelet and Plasma Components
          • Table 3: Visual Inspection of Derivatives
      4.4 Quarantine all blood, blood components and/or derivatives that fail the visual
          inspection to ensure that they are not inadvertently used.
          • Place the blood, blood component or derivative in suitable storage that is
            clearly labelled and away from general inventory and assigned units.
          • Complete FormINV.003 and fax to the appropriate CBS department.
          • Return unit to CBS or discard as appropriate.
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Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 1 of 
      4.5 Document the results of the visual inspection and the final disposition of the
          product in the appropriate Issue/Transfusion Record (lab log).

Table 1: Visual Inspection of Red Cell/Whole Blood Components
 Abnormality          Description                    Action                      Reporting
 Open ports           Port covers should be          • Quarantine the unit       Document in the Issue/
                      intact unless product          • Notify CBS or your BTS,   Transfusion Record (lab log)
                      has been modified. If          where applicable            Complete Customer
                      modified, then must have                                   Feedback FormINV.003
                      at least one original port     • Return the unit to CBS
                      with cover intact.*            or discard as appropriate
 Purple or black      Suspect hemolysis              • Quarantine the unit       Document in the Issue/
 red cell mass        due to either physical         • Notify CBS or your BTS,   Transfusion Record (lab log)
                      destruction of red             where applicable            Complete Customer
                      cells or by bacterial                                      Feedback FormINV.003
                      contamination.           • Return the unit to CBS
                                               or discard as appropriate
 Discolored plasma    Bacterially contaminated • Quarantine the unit             Document in the Issue/
 or supernatant,      plasma may appear a      • Notify CBS or your BTS,         Transfusion Record (lab log)
 if visible           grayish murky color,     where applicable                  Complete Customer
 Note: Check unit     purple or brown.                                           Feedback FormINV.003
                                               • Return the unit to CBS
 and segments                                  or discard as appropriate
 Bright red           May indicate significant • Quarantine the unit             Document in the Issue/
 plasma color         red cell hemolysis.      • Notify CBS or your BTS,         Transfusion Record (lab log)
 Note: Check unit                                    where applicable            Complete Customer
 and segments.                                       • Return the unit to CBS    Feedback FormINV.003
                                                     or discard as appropriate
 No segments          Ensure that at least           • Notify your BTS, if       Document in the Issue/
                      one donor segment is           applicable                  Transfusion Record (lab log)
                      attached to the unit.          • Discard the unit
 Clots                Mix the unit. Observe          • Quarantine the unit       Document in the Issue/
                      for clots.                     • Notify CBS or your BTS,   Transfusion Record (lab log)
                                                     where applicable            Complete Customer
                                                     • Return the unit to CBS    Feedback FormINV.003
                                                     or discard as appropriate
 Red cell color in    The red cell color             • Quarantine the unit       Document in the Issue/
 the segment(s) is    in the segment(s) is       • Notify CBS or your BTS,       Transfusion Record (lab log)
 different than in    significantly lighter than where applicable                Complete Customer
 the unit             in the unit.                                               Feedback FormINV.003
                                                 • Return the unit to CBS
                                                 or discard as appropriate
 Expired              The product must be        • Notify your BTS, if           Document in the Issue/
                      indate.                    applicable                      Transfusion Record (lab log)
                                                     • Discard the unit
* Modified products are products that have been manipulated in an open system.
NOTE: When returning products to CBS additional supporting documentation should be included if
applicable (such as packing slips, issuing forms, test results, etc.).


                                                                                            Module	3	•	INV.005
2 of  • Manitoba Transfusion Quality Manual for Blood Banks                             Version 2 • June 2007
Table 2: Visual Inspection of Platelet and Plasma Components
 Abnormality Description                              Action                        Reporting
 Open ports        Port covers should be intact,      • Quarantine the unit.        Document in the Issue/
                   unless product has been            • Notify CBS or your BTS,     Transfusion Record (lab log)
                   modified. If modified, then        where applicable              Complete Customer
                   must have at least one original                                  Feedback FormINV.003
                                                      • Return the unit to CBS
                   port with cover intact.*
                                                      or discard as appropriate
 Red cell      ONLY applicable to Rh                  BTS Medical Director          Document consult in the Issue/
 contamination negative females less than 45          approval is needed            Transfusion Record (lab log)
 of platelets  years of age when transfusing                                        Complete Customer
               Rh positive platelets to an Rh                                       Feedback FormINV.003
               negative recipient.
 Plasma color is Indicates significant                • Quarantine the unit         Document in the Issue/
 bright red.     hemolysis.                           • Notify CBS or your BTS,     Transfusion Record (lab log)
                                                      where applicable              Complete Customer
                                                      • Return the unit to CBS      Feedback FormINV.003
                                                      or discard as appropriate

 Clumps in unit Excessive aggregates in               BTS Medical Director          Document consult in the Issue/
                platelets                             approval is needed.           Transfusion Record (lab log)
                                                                                    Complete Customer
                                                                                    Feedback FormINV.003
 Discolored        Bacterially contaminated      • Quarantine the unit              Document in the Issue/
 plasma            plasma may appear a grayish • Notify CBS and your                Transfusion Record (lab log)
                   murky color, purple or brown. BTS, where applicable              Complete Customer
                                                 • Return the unit to CBS           Feedback FormINV.003
                                                 or discard as appropriate
 Grossly           Milky plasma.                      • Quarantine the unit         Document in the Issue/
 lipemic                                              • Notify CBS or your BTS,     Transfusion Record (lab log)
                                                      where applicable              Complete Customer
                                                      • Return the unit to CBS      Feedback FormINV.003
                                                      or discard as appropriate

 Intense yellow May indicate an abnormally            • Quarantine the unit         Document in the Issue/
 color          high bilirubin level.                 • Notify CBS or your BTS,     Transfusion Record (lab log)
                                                      where applicable              Complete Customer
                                                      • Return the unit to CBS      Feedback FormINV.003
                                                      or discard as appropriate
 Signs of          Frozen plasma bags are brittle • Notify your BTS, if             Document in the Issue/
 breakage          and subject to breaking if     applicable                        Transfusion Record (lab log)
                   mishandled.                    • Discard the unit
 Expired           The product must be indate.        • Notify your BTS, if         Document consult in the
                                                      applicable                    Issue/Transfusion Record
                                                      • Discard the unit            (lab log)

* Modified products are products that have been manipulated in an open system.
NOTE: When returning products to CBS, additional supporting documentation should be included if
applicable (such as packing slips, issuing forms, test results, etc.).

Module	3	•	INV.005
Version 2 • June 2007                                Manitoba Transfusion Quality Manual for Blood Banks • 3 of 
Table 3: Visual Inspection of Derivatives

 Abnormality Description                           Action                    Reporting
 Product           Cloudiness may indicate         • Quarantine the product Document in the Issue/
 appears           bacterial contamination or      • Notify CBS or your BTS, Transfusion Record (lab log)
 cloudy            the presence of particulate     where applicable          Complete Customer Feedback
                   matter                                                    FormINV.003
                                                   • Return the product
                                                   to CBS or discard as
                                                   appropriate
 Expired           The product must                Discard the product       Document in the Issue/
                   be indate.                                                Transfusion Record (lab log)
 Sterile cap       Cap covers must be intact       Discard the product       Document in the Issue/
 covers not                                                                  Transfusion Record (lab log)
 intact
 Signs of          Check for cracks or             Discard the product       Document in the Issue/
 breakage          leaking in vial or bottle.                                Transfusion Record (lab log)
NOTE: When returning products to CBS, additional supporting documentation should be included if
applicable (such as packing slips, issuing forms, test results, etc.).


5.0 Reporting
      See Tables 1, 2 and 3.

6.0 Procedural Notes
      6.1 The shelf life of fresh and frozen blood and blood components is documented
          in the CBS Circular of Information for the Use of Human Blood and Blood
          Components.
      6.2 All blood, blood components or derivatives that fail visual inspection must
          be quarantined to ensure that they are not inadvertently used.
           • Affix a note onto the unit(s) clearly stating “Quarantined: DO NOT USE”.
           • Describe the reason for the quarantine. Date and initial the note.
           • Place in a separate bag and attach “Dangerous” tag obtained from CBS.
           • Place the blood, blood component or derivative in suitable storage that is
             clearly labelled and away from general inventory and assigned units.
      6.3 If there is no expiry label on a blood, blood component or derivative, an incident
          report should be completed and submitted to a supervisor.
           6.3.1 The BTS Medical Director or designate must authorize the release of the
                 blood, blood component or derivative.
                • This authorization must be documented.




                                                                                         Module	3	•	INV.005
4 of  • Manitoba Transfusion Quality Manual for Blood Banks                          Version 2 • June 2007
      6.4 Units that appear darker than normal or have murky plasma/supernatant may
          be bacterially contaminated and recommended follow-up is to culture and stain
          the contents of the unit(s).
          6.4.1 The gram stain is most often employed, although Wright’s stain and acridine
                orange have also been recommended.
                • If bacteria are detected in the culture or stain, discard the unit. Notify
                  the blood supplier. Refer to Tables 1, 2 and 3
                • If bacteria are not detected, the unit should still be discarded.
      6.5 Red cell units with a bright red plasma color may indicate significant red cell
          hemolysis.
          • Centrifuge or allow the red cells in the unit to settle (2-3 days). Observe the
            plasma carefully (ideally comparing to other units). Optional testing may
            include a plasma hemoglobin level.
          • If significant red cell hemolysis is noted, discard the unit. Notify the blood
            supplier. Refer to Tables 1, 2 and 3.
      6.6 Red cell units that are labelled as “AS-3 Red Blood Cells” should weigh at least
          325 grams.
          • If the unit appears small (less than 325 grams), centrifuge or allow the red
            cells to settle to ensure that the AS-3 additive was added to the unit.
          • Upon centrifugation or settling (2-3 days), the unit should contain clear
            supernatant.
          • If a unit labelled as “AS-3 Red Blood Cells” does not appear to contain
            supernatant additive, the unit must not be used. Notify the blood supplier
            immediately. Refer to Tables 1, 2 and 3.
          • If the unit is subsequently discarded or returned to the blood supplier,
            the appropriate documentation must be completed.
      6.7 Plasma or platelet units with an intense yellow color may indicate an
          abnormally high bilirubin level.
          • Test the plasma (preferably from a segment) for a total bilirubin assay.
          • If test results are normal, the unit may be used for transfusion purposes.
          • If the results are abnormal, discard the unit. Notify the blood supplier. Refer
            to Tables 1, 2 and 3
      6.8 If ‘other products’ such as derivatives appear cloudy, compare the product’s
          contents with the contents of a similar product.
          • If only the bottle or vial being inspected is cloudy, discard the product.
            Notify the blood supplier. Refer to Tables 1, 2 and 3.




Module	3	•	INV.005
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks •  of 
    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)




                                                                                              Module	3	•	INV.005
 of  • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                         INV.006		
ABO/Rh Confirmation Testing Red Cell Units (Crossmatch Facilities)


1.0 Principle
      1.1 To confirm the ABO group of red cell units.
      1.2 To confirm the Rh type of Rh negative red cell units

2.0 Scope and Related Policies
      2.1 The ABO group shall be re-tested on all donor red cell units prior to transfusion.
      2.2 ABO confirmation testing shall be performed using anti-A and anti-B for groups
          A, B, and AB and anti-A, B for Group O.
      2.3 The Rh type shall be re-tested on all Rh negative donor red cell units prior
          to transfusion. An Rh control is not required unless a discrepancy is found.
      2.4 Any discrepancies shall be resolved before issue of the red cell units for
          transfusion purposes. Unresolved discrepancies must be reported to the
          blood supplier.

3.0 Materials
      Serologic centrifuge
      Work block(s)
      Tubes
      Transfer pipettes
      Anti-A, anti-B and anti-A,B commercial antisera
      Anti-D commercial antisera
      Saline
      ABO/Rh Confirmation Testing Worksheet

4.0 Procedure
      4.1 Perform ABO/Rh confirmation testing before placing donor red cell units into
          inventory or prior to issue, as applicable. Perform testing according to the
          following table:

 Donor ABO/Rh           Anti-A         Anti-B               Anti-A,B               Anti-D
 O pos                                                      X
 A pos                  X              X
 B pos                  X              X
 AB pos                 X              X
 O neg                                                      X                      X
 A neg                  X              X                                           X
 B neg                  X              X                                           X
 AB neg                 X              X                                           X

Module	3	•	INV.006
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
        4.2 For each red cell unit to be tested:
           4.2.1 Label a tube with a sticker from the back of the unit. Ensure the unit number
                 on the sticker is identical to the unit number on the primary label on the
                 front of the donor bag. Alternatively, transcribe the unit number directly
                 from the primary label onto the tube.
           4.2.2 Detach two segments:
                  • Label one segment with a sticker from the back of the unit. If there are no
                    stickers, write the supplier/centre code, check digit and unit number on a
                    piece of tape or a blank label and attach the tape/label to the segment.
                  • Place the labelled segment into a plastic “segment” bag labelled with the date
                    of receipt. Store segments at 1 to 6°C for a minimum of 7 days past expiry.
                  • Place the second segment into a labelled tube.
           4.2.3 Record the unit number on “ABO/Rh confirmation Testing Worksheet”.
                 Use a sticker from the unit if available.
           4.2.4 Prepare a 3% cell suspension, refer to Module 2 MP.006
        4.3 Label tubes for testing 1, 2, 3, etc. (label according to position in the block).
            Place the tubes in the block.
        4.4 Perform the ABO/Rh testing. After centrifuging, place the tubes in numerical
            order back in the block. Refer to Module 2 MP.008 and MP.009
        4.5 Read macroscopically and record test results for 1 unit at a time. Record test
            results on the worksheet.
        4.6 Compare the results to the ABO/Rh on the primary unit label to confirm the
            ABO/Rh of the unit. Refer to procedural note 6.1.
        4.7 Place all units that have been completely tested into inventory.

5.0 Reporting
        N/A

6.0 Procedural Notes
        6.1 If results of the donor ABO/Rh confirmation testing do not agree with the
            primary unit label, repeat the testing using a new segment. Wash the red cells
            once before testing. If the results still do not agree, quarantine the unit and
            notify the blood supplier for further instructions.


    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	    											__________________________________	   __________________________________
    	         	      	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	      	       	            	       	      	
    Facility	effective	date:			__________________________________
    	         	      	       									(Date	of	implementation)


                                                                                               Module	3	•	INV.006
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                                Version 2 • June 2007
                                        INV.007		
         Issuing Blood, Blood Components and Derivatives


1.0 Principle
      To issue blood, blood components or derivatives for transfusion/infusion from
      the facility blood bank.
      To return blood, blood components or derivatives to facility blood bank or BTS.
      To document the release and final disposition of blood, blood components or
      derivatives using the Issue/Transfusion Record (lab log), and appropriate facility form.
      NOTE: In some facilities, the issuer and the transporter may be the same individual
      and must adhere to both this guideline and to guideline INV.008.

2.0 Scope and Related Policies
      2.1 A record keeping system shall be in place for each issued blood, blood component
          and derivative.
      2.2 As per facility policy, at the time of issue, there shall be a final verification of the
          patient information and the blood, blood component or derivative information.
          This may include the request form, Issue/Transfusion Record (lab log), tag and
          blood, blood component or derivative.
      2.3 If the information does not agree, the blood, blood component or derivative
          shall not be issued for transfusion/infusion. Discrepancies shall be resolved.
      2.4 The record keeping system shall ensure that a copy of all of the information
          relating to the patient and the transfused blood, blood component or derivative
          becomes a permanent transfusion/infusion record for the patient.
      2.5 The record keeping system shall be designed to facilitate the tracing of blood,
          blood components and derivatives from source (the donor or the collecting
          facility) to final disposition (transfused/infused, shipped, discarded), to recheck
          the records applying to the blood, blood components or derivatives, and to
          investigate adverse reactions manifested by the patient. These records must
          be kept indefinitely.
      2.6 Only authorized individuals who have been trained in the issuing process shall
          issue blood, blood components or derivatives.
      2.7 A visual inspection shall be performed immediately before issuing all blood,
          blood components and derivatives.
      2.8 For emergency issue of Group O or group specific unmatched red cell units refer
          to Module 2 MP.018.
      2.9 When issued blood, blood components and derivatives are transported out of the
          facility with the patient, the receiving facility shall be responsible for the final
          disposition documentation.


Module	3	•	INV.007
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 
      2.10 When issued blood, blood components and derivatives are shipped out of
           the province with a patient, the issuing facility shall be responsible for final
           disposition documentation.
      2.11 Certain criteria shall be met when blood, blood components and/or derivatives
           have been returned to the BTS or blood bank before they can be reissued.

3.0 Materials
      Tagged blood, blood components or derivatives
      Applicable facility forms
      Issue/Transfusion Record (lab log)

4.0 Procedure
      4.1 Procedure for Issuing
          4.1.1 When the blood, blood component or derivative is required for transfusion/
                infusion the following information must be brought to the blood bank.
                Retrieve the patient’s request form, CBS Patient Report or product packing
                slip, if applicable.
                Refer to procedural note 6.1.
                • Patient’s last and first name
                • Patient’s PHIN or unique identifier
                • Date
                • Type of blood, blood components or derivatives required
                • Number of units/dose required
                NOTE: Issue only 1 unit at a time unless the ward has a controlled blood
                bank refrigerator for storage. An exception to this would be if 2 units are
                being transfused at the same time through 2 different lines (e.g. severe
                trauma patient) or if the units are pooled.
          4.1.2 Prior to retrieving red cells, ensure the “crossmatch outdate” on the patient
                request form and/or the CBS Patient Report or the Issue/Transfusion Record
                (lab log) is indate.
          4.1.3 Retrieve the requested blood, blood component or derivative from the
                appropriate controlled storage area. Refer to the following procedures
                and procedural notes for additional information regarding issuing.
                • Procedural note 6.2: Issuing autologous/directed donor units
                • Procedural note 6.3: Issuing blood and blood components, (i.e.,
                  crossmatched red cell units) for transport with a patient.
                • Procedural note 6.4: Issuing a divided or aliquoted unit.
                • Procedural note 6.5 :Issuing lot numbered products
                • Procedural note 6.6: Issuing Factor Concentrates to Patients Registered
                  with the Manitoba Bleeding Disorders Program.
                • Procedural note 6.7: Issuing Rh Immune Globulin (WinRho®) to
                  an authorized health care provider or clinic.
                • Module 2 MP.018: Emergency Issue of Donor Red Cell Units.
                                                                                 Module	3	•	INV.007
2 of  • Manitoba Transfusion Quality Manual for Blood Banks                  Version 2 • June 2007
          4.1.4 Verify the applicable information on the request form/patient information
                form, Issue/Transfusion Record (lab log) with the tag and blood, blood
                component and/or derivative:
                • Patient’s last and first name, letter by letter
                • Patient’s PHIN or unique identifier, character by character
                • Patient’s ABO/Rh type
                • Blood, blood component unit number including check digit, supplier
                  (centre) code or derivative lot number(s)
                • Blood, blood component or derivative pool number (if used)
                • Blood or blood component ABO/Rh type
                • Compatibility status
                • Date and time of issue
                • Verification of special transfusion/infusion requirements
                • Name and signature of the person issuing the product
                • Name and signature of the person transporting the product to patient location.
                NOTE: It is preferable to always have 2 individuals checking and issuing
                blood, blood components or derivatives from the blood bank.
          4.1.5 Ensure that all discrepancies detected in step 4.1.4 are resolved by the facility
                blood bank or BTS before the blood, blood component or derivatives are issued.
          4.1.6 Perform a visual inspection of each product.
                NOTE: If the blood, blood component or derivative does not pass visual
                inspection it must not be issued nor transfused/infused.
          4.1.7 Document the visual inspection and the following information in the Issue/
                Transfusion Record (lab log) and tag, if applicable:
          a)    Patient information:
                • Patient’s last and first name
                • PHIN or unique identifier
                • ABO/Rh, if applicable
          b)    Blood, Blood Component Or Derivative Information:
                • Blood, blood component or derivative type
                • Donor unit number including check digit and supplier (centre code)
                  or lot number
                • ABO/Rh, if applicable
                • Quantity, if applicable
                • Crossmatch outdate, if applicable
                • Product expiry date




Module	3	•	INV.007
Version 2 • June 2007                             Manitoba Transfusion Quality Manual for Blood Banks • 3 of 
          c)    Issuing Information:
                • Date and time
                • Visual inspection
                • Full last name of the issuer (print or legibly sign). For use of initials,
                  refer to procedural note 6.8.
                • Full last name of the transporter (print or legibly sign) in the “Transporter”
                column if applicable.
                • Patient location, if required by your facility.
          4.1.8 Issue the blood, blood component or derivative to the transporter along
                with the chart copy of the request requisition if applicable.
          4.1.9 Package the blood, blood component or derivative for transport.
          4.1.10 File the blood bank copy of all appropriate forms.
      4.2 Procedure for Returning Blood, Blood Components and Derivatives to Inventory
          4.2.1 Document date and time of return in the Issue/Transfusion Record (lab log)
                and tag, if applicable.
          4.2.2 Visually inspect the product to ensure the following criteria are met prior
                to returning blood, blood components and derivatives to inventory:
                • The blood bag/vial closure has not been disturbed
                • The blood or blood component has not been held at room temperature for
                  longer than 30 minutes during storage or transportation. For equivalent length
                  of time for derivatives at room temperature, check product monograph.
                • At least one segment of integral donor tubing has remained attached to
                  the product bag. Previously removed segments may be reattached after
                  confirming that the tubing identification number is identical on both the
                  removed segments and on the product bag.
          4.2.3 Discard the blood, blood component or derivative if the above conditions
                are not met. Document as per “Final Disposition” section 4.4.
          4.2.4 Return the blood, blood component or derivative to appropriate controlled storage.
      4.3 Procedure for Re-Issue
          • Follow procedure for Issuing
      4.4 Procedure for Final Disposition Documentation
          Documenting the final disposition in the Blood, Blood Components and
          Derivatives Issue/Transfusion Record (lab log).
          4.4.1 Issued blood, blood components and derivatives.
                • Transfusion confirmed: If the tag is returned, the product is considered
                  ‘confirmed transfused’.
                • Transfusion presumed: If the tag is not returned, the product is considered
                  ‘presumed transfused.’
          4.4.2 Transferred blood, blood components and derivatives to another facility
                (with or without a patient).
                 • Document the facility
                                                                                   Module	3	•	INV.007
4 of  • Manitoba Transfusion Quality Manual for Blood Banks                    Version 2 • June 2007
          4.4.3 Discarded blood, blood components and derivatives (specify the reason
                for discard)
                 • Expired: The product is past the expiry date indicated on the label.
                 • Broken Bag: The unit bag is broken or damaged.
                 • CBS initiated Discards: Canadian Blood Services advises that specific
                   units should be discarded.
                 • Crossmatched by CBS-indate: The unit has been crossmatched by CBS,
                   the unit has not expired and the crossmatch is still indate, but the unit has
                   been discarded
                 • Crossmatched by CBS-outdate: The unit has been crossmatched by CBS
                   and the crossmatch sample has expired for the units, but not the donor
                   unit expiry date indicated on the label.
                 • Crossmatched by Other: The unit has been crossmatched by a facility
                   other than CBS the unit has not expired and the crossmatch is still indate,
                   but the unit has been discarded.
                 • Damaged Label: The label on the unit has been damaged or defaced.
                 • Improper Storage: The unit has been improperly stored.
                 • No Segments: The unit has no segments.
                 • Out of Storage for longer than 30 minutes: The unit has been out
                   of controlled storage for longer than 30 minutes.
                 • Thawed and not used: The unit has been thawed and not used.
                 • Other: Any other reason for the unit to be discarded (specify).
          4.4.4 Return the blood, blood components or derivatives to BTS or CBS
                Document when the product was returned to BTS or CBS

5.0 Reporting
      N/A

6.0 Procedural Notes
      6.1 Blood, blood components and derivatives can only be issued immediately prior to
          the patient being transfused/infused in order to maintain proper storage of the
          blood, blood component or derivative.
      6.2 Issuing Autologous/Directed Donor Units
          Autologous and then Directed units must be issued prior to homologous units.
      6.3 Issuing blood, blood components and derivatives for transport with
          a patient.
          • Refer to INV.009.
          • Write “Shipped to ___________” across “DISPOSITION”.
      6.4 Issuing a divided or aliquoted unit.
          Refer to facility policies and procedures


Module	3	•	INV.007
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks •  of 
        6.5 Issuing lot numbered products.
            • Prepare and attach patient identification label(s) for each vial of product to be issued.
           • Record patient and lot number information in the Issue/Transfusion Record (lab log).
           • If issuing multiple vials, record the number of vials beside the lot number.
           • If issuing a pooled product ensure the total grams or international units (IU) are
             correct. Record the weight and volume of the pooled product on the request form.
        6.6 Issuing Factor Concentrates to Patients Registered with the Manitoba
            Bleeding Disorders Program
            6.6.1 Ask for the patient’s name and PHIN or unique identifier when derivatives
                  are requested by the patient (or parent, guardian, or designate). To confirm
                  patient identity, verify patient name and PHIN or unique identifier with
                  records and with patient’s health card.
                 NOTE: If the patient is not registered and is requesting product, consult the
                 Manitoba Bleeding Disorders Program at (204) 787-2465 or page at (204)
                 787-2071, pager 3346 or contact the Adult/Pediatric Hematologist on call
                 at Health Sciences Centre at (204) 787-2071.
           6.6.2 The derivative will have already been shipped to the designated facility. The
                 patient’s last and first name, PHIN or unique identifier, derivative name and
                 amount ordered should be documented on the blood supplier packing slip.
           6.6.3Retrieve the derivative from the appropriate storage area.
           6.6.4Complete all applicable steps for issuing derivatives with the following
                additional information:
                 • Ask patient (or parent/guardian) to sign as the transporter.
                 • Issue the product(s) to the patient (or parent/guardian).
        6.7 Issuing Rh Immune Globulin (WinRho®) to an authorized health care
            provider or clinic:
            • Obtain the patient’s last and first name and PHIN or unique identifier.
           • Record patient and derivative information in the Issue/Transfusion Record (lab
             log) at the time of issue.
           • Write,” Shipped to __________” across “DISPOSITION”.
        6.8 Initials of the individuals who issue blood, blood components or derivatives may
            only be used if an Initial Log of all employees who issue or transport blood,
            blood components and derivatives is maintained and updated regularly.

    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	        	      	       												(Senior	Management)	    	    	      		(Senior	Management)
    	        	      	       	            	       	      	
    Facility	effective	date:			__________________________________
    	        	      	       									(Date	of	implementation)


                                                                                              Module	3	•	INV007
 of  • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                       INV.008		
    Transport of Blood, Blood Components and Derivatives
                      (Within a Facility)


1.0 Principle
      To provide guidelines for transport of blood, blood components and derivatives from
      the blood bank/lab to an authorized staff member at the patient’s location, or to a
      controlled satellite blood bank refrigerator.

2.0 Scope and Related Policies
      2.1 Facility policies must be in place that clearly define individuals who may transport
          blood, blood components or derivatives from the blood bank/lab and transport
          them to the patient’s location.
      2.2 Documentation of appropriate training for the handling and transportation
          of blood, blood components or derivatives must be in place and maintained.
      2.3 The transporter must sign in the appropriate column in the Issue/Transfusion
          Record (lab log) for each issued blood, blood component or derivative
          requiring transport.
      2.4 The blood, blood components or derivatives must be transported to the patient’s
          location immediately.
      2.5 The blood, blood components or derivatives must be returned to the blood bank/
          lab within 30 minutes of issue, if the decision is made not to transfuse/infuse.

3.0 Materials
      Issue/Transfusion Record (lab log)
      Applicable facility forms
      Protective covering is recommended

4.0 Procedure
      4.1 Ordering ward shall contact transporter personnel (facility specific) either verbally
          or electronically.
          NOTE: In some facilities the issuer and the transporter may be the same individual
          and must adhere to both guidelines, refer to INV.007 and INV.008.
      4.2 Physical Transport
          Manual transport of blood, blood components or derivatives by hand.
          The transporter will:
          4.2.1 Respond to the request on a priority basis as per established facility policies
                and procedures.



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           4.2.2 If the transporter is also the issuer then follow INV.007.
           4.2.3 Sign in the appropriate column of the Issue/Transfusion Record (lab log)
                 for the blood, blood components or derivatives.
           4.2.4 Transport the blood, blood components or derivatives and relevant
                 documentation to the patient’s location immediately.
                • Protective covering for blood, blood components or derivatives is
                  recommended (e.g., a plastic or zip-lock bag).
           4.2.5 Hand the blood, blood components or derivatives directly to an authorized
                 staff member at the patient’s location.
                NOTE: Blood, blood components or derivatives must not be left without
                the acknowledgement of the staff at the patient’s location.
           4.3 Pneumatic Tube
                Transport of blood, blood components or derivatives using pneumatic
                tube system.
                The blood bank/lab staff will:
           4.3.1 Receive patient information and request for blood, blood components
                 and derivatives from the transfusion/infusion location.
           4.3.2 Issue blood, blood components or derivatives as described in INV.007
           4.3.3 Pack blood, blood components or derivatives in the pneumatic tube as
                 per system specifications.

5.0 Reporting
        Document on appropriate record as per established facility policies and procedures,
        the identity of the transporter (as applicable).

6.0 Procedural Notes
        6.1 Blood, blood components or derivatives for transfusion/infusion must be:
           • Initiated, or
           • Stored in a controlled satellite blood bank refrigerator, or
           • Returned to the blood bank/lab within 30 minutes.



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	        												(Senior	Management)	    	   	      		(Senior	Management)
    	       	       	        	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	        									(Date	of	implementation)




                                                                                              Module	3	•	INV.008
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                      INV.009		
        Inter-facility Shipping of Blood, Blood Components
                           and Derivatives


1.0 Principle
      1.1 To provide a uniform process for shipping and tracking blood, blood components
          and derivatives which may or may not accompany a patient.
      1.2 To ensure that the blood, blood components and derivatives are maintained
          at the appropriate prescribed temperature range during shipping.

2.0 Scope and Related Policies
      2.1 Each shipment of blood, blood components or derivatives shall be accompanied
          by the shipping document FormINV.002.
      2.2 All blood, blood components or derivatives shall be visually inspected
          immediately before packing for shipping. This inspection must be documented.
      2.3 Acceptable conditions for the blood, blood components or derivatives shall be
          maintained during shipping.
          • Blood and blood components with a required storage temperature of 1 to 6°C
            shall be shipped in a manner that will ensure maintenance of a temperature in
            the range of 1 to 10°C.
          • Blood components or derivatives required to be stored at 20 to 24°C, shall be
            shipped at 20 to 24°C.
          • Frozen blood components must be shipped in a manner designed to maintain
            their frozen state.
          • Platelet agitation may be discontinued for up to 24 hours during shipping.
          • Derivatives with a required storage temperature of 2 to 8°C shall be shipped in a
            manner that will ensure maintenance of a temperature in the range of 1 to 10°C.

3.0 Materials
      CBS shipping container, i.e., 2” inner styrofoam container with a heavy outer
      cardboard box, dimensions 11.5” w X 12.5” h X 11.5” d
      Plastic bag
      Gel pack(s) (4 lb Rapid Air Gel Pack), dimensions 10.5” w X 9.5” h
      Ice pack(s), dimensions 8” w X 8” h
      Corrugated cardboard insert(s), dimensions at least 8” w X 8” h
      Newspaper (folded)
      Address label
      Waybill (if applicable)
      Security seals
      Issue/Transfusion Record (lab log)
      – Coninued next page
Module	3	•	INV.009
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 4
      Patient report
      Packing slip
      Inter-facility Blood, Blood Component and Derivative Transfer Form (FormINV.002,
         refer to Forms Section)
      Patient Care Team Instructions: Handling Blood, Blood Components and Derivatives
         Shipped with a Patient (FormINV.004, refer to Forms Section)

4.0 Procedure
      4.1 Determine which blood, blood components or derivatives are to be shipped and
          what type of shipping container(s) is/are to be used.
          • If shipping by public transport, avoid shipping any blood, blood components
            or derivatives on a Friday or before a statutory holiday that may not guarantee
            delivery within 24 hours.
      4.2 Inspect the shipping container and ensure:
          • The inner container is clean and free of breaks,
          • The security seals and buckles are in good condition,
          • The outer container is free of breaks,
          • There are no conflicting address labels on the outer container.
      4.3 Prepare the shipping container according to the criteria in the following table.
          NOTE: Maximum number of blood or blood components to be packaged in one
          shipping container is:
          • Red cell or thawed plasma units: 10
          • Platelet units: 30
          • Plasma (frozen): 8 to 20 depending on the size of the container

 Outdoor           Component              Type       Placement of Pack(s) and                    Pack Storage
 Temperature at                           of Pack    Cardboard Inserts                           Temperature
 Shipping Facility                                                                               Before Using
 Less	than	or	equal		 All	blood	        Ice	pack     One	pack:	upright	at	one	end	of	the	        -20	±	3°C	for	at	
 to	15°C              products	stored	               shipping	container.                         least	24	hours*
                      between	1	and	                 Cardboard:	Place	2	inserts	next	to	ice	pack.
                      6	°C.	
 Greater	than	15°C                      Ice	pack     Two	packs:	place	upright,	one	at	each	       -20	±	3°C	for	at	
                      (e.g.	red	cells,	              end	of	the	shipping	container.               least	24	hours*
                      whole	blood,	
                                                     Cardboard:	Place	2	inserts	next	to	each	
                      thawed	plasma	
                                                     ice	pack	(total	of	4	inserts	needed).
                      and	derivatives)
 All	temperatures     Platelets         Gel	pack	    Two	packs:	place	flat,	one	at	the	          22	±	2°C	for	at	
                                        (Room		      bottom	of	container,	and	one	on	top		       least	24	hours
                                        Temp)        of	units.

* If ice pack storage is colder than –20 ± 3°C, ensure that there are 4 cardboard inserts between
the ice packs and the blood or blood components.




                                                                                                Module	3	•	INV.009
2 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                                 Version 2 • June 2007
      4.4 Prepare a separate FormINV.002 for each shipping container.
          • Refer to Appendix 2 Facility Contact List for shipping addresses for facilities
            within Manitoba.
          • Obtain the name of the destination facility and the identity of the transport
            personnel, if shipment accompanies a patient.
      4.5 Remove from storage and issue blood, blood component or derivative (refer to
          INV.007) before packaging.
      4.6 Pack red cell, platelet units, frozen products or derivatives in separate shipping
          containers according to acceptable shipping conditions.
          • Place each type of blood, blood component or derivative in separate plastic
            bag(s) within the appropriate shipping container.
          4.6.1 If using ice packs:
                • Place the plastic bag(s) containing the blood, blood components and
                  derivatives upright between the cardboard inserts.
                • The blood, blood components and derivatives must be insulated from
                  the ice pack(s) by the cardboard inserts.
          4.6.2 If using gel packs:
                • Place one gel pack flat on the bottom of the shipping container.
                               Cardboard




                        Ice                Blood
                        pack               Components




                • Place the plastic bag containing the platelets on top of the gel pack.
                • Place the second gel pack flat on top of the units.
      4.7 Fill any empty space with paper. This will keep the units from moving around
          during shipping and will help maintain a stable temperature inside the shipping
          container.

                   Gel Pack

                    Blood Component

                    Gel Pack

      4.8 Close the lid of the inner Styrofoam container.
      4.9 Photocopy and retain a copy of FormINV.002.
      4.10 Place the original FormINV.002 and BTS patient report (if applicable) on the top
           of the Styrofoam lid in the shipping container.

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Version 2 • June 2007                               Manitoba Transfusion Quality Manual for Blood Banks • 3 of 4
        4.11 Close the cardboard shipping container, fasten the strap securely, and attach a
             security seal to the strap.
           • Security seals are usually plastic and must be placed through the two sides of
             the strap. This provides assurance that the box was not opened “en route”.
        4.12 Address the shipping container.
           • If shipping by public transport, place a large label with the address of the
             receiving facility on the outside of the container and ensure a “Do Not Freeze”
             or “Must Ride” label is affixed.
           • If shipping with a patient, tape FormINV.004, to the outside of the container.
        4.13 Prepare a waybill if applicable, and attach to the shipping container.
           • Retain shippers copy
        4.14 Contact one or more of the following to arrange for shipping
           • Designated transport personnel
           • Patient care area, or
           • Patient transport personnel.
        4.15 Fax a copy of FormINV.002 to the receiving facility lab/blood bank (refer to
             Appendix 2).

5.0 Reporting
        Document the transfer information (including facility) and the blood, blood
        components and/or derivatives’ information in the Issue/Transfusion Record (lab log).

6.0 Procedural Notes
        N/A



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	         	     	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	     	       	        	        	        	
    Facility	effective	date:			__________________________________
    	         	     	       									(Date	of	implementation)




                                                                                              Module	3	•	INV.009
4 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                         INV.010		
       Documenting the Final Disposition of Returned or
      Discarded Blood, Blood Components and Derivatives


1.0 Principle
      To discard and document the final disposition of all blood, blood components
      and derivatives not suitable for transfusion/infusion.

2.0 Scope and Related Policies
      2.1 Blood, blood components and derivatives shall be traceable from source to
          final disposition, i.e., visual inspection failure, transfusion/infusion, further
          manufacturing, or destruction.
      2.2 Records of discarded blood, blood components and derivatives shall be kept
          indefinitely.
      2.3 The expiration date is the last day on which the blood, blood component
          or derivative should be used for transfusion/infusion purposes.
      2.4 When a shipment is received for blood inventory purposes, the receiving
          facility shall be responsible for final disposition documentation.

3.0 Materials
      Blood, blood components and derivatives ‘Not Suitable for Transfusion’
      Blood Bank Customer Feedback Form (FormINV.003), refer to Forms Section
      Issue/Transfusion Record (lab log)
      Autologous/Directed Form

4.0 Procedure
      4.1 Record the following on the Issue/Transfusion Record (lab log):
          • Date product is discarded.
          • Blood, blood component or derivative type.
          • ABO/Rh, supplier (centre) code, check digit and unit number for fresh and
            frozen products.
          • For derivatives record the lot number, vial size and number of vials being
            discarded.
      4.2 Record the final disposition as follows:
          • Blood, blood component or derivative is discarded: Document as discarded
          • Blood, blood component or derivative is returned to the supplier: Document
            as returned




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Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
      4.3 Record the reason as to why the blood, blood component or derivative was
          unsuitable for transfusion/infusion.
          • Expired (product expiration date has been exceeded).
          • Breakage.
          • Out of a controlled storage device for greater than 30 minutes.
          • Improper storage (fridge or freezer malfunction).
          • Frozen product was thawed and not used.
          • Crossmatched by CBS – Outdated (red cell units, crossmatched by CBS, are
            discarded when the crossmatch specimen is outdated but the red cell unit has
            not expired).
          • Crossmatched by CBS - Indate (red cell units, crossmatched by CBS, are discarded
            even though the crossmatch is indate and the red cell unit has not expired).
          • Crossmatched by Other (red cell units, crossmatched by a facility other than
            CBS, are discarded even though the crossmatch is indate and the red cell unit
            has not expired).
          • Failed visual inspection criteria, e.g., hemolysis, icteric, etc.
          • Quality control failure, e.g., positive direct antiglobulin test on unit, inadequate
            or incorrect labeling, damaged label.
          • No available segments on red cell unit(s) for crossmatch purposes.
          • Blood supplier initiated the discard or recall.
          • Other (any other reason for the product to be discarded).
      4.4 Discard the blood, blood component or derivative in an appropriate biohazard
          receptacle.
          Return the product to the blood supplier if it is unsuitable for transfusion due
          to a defect or quality issue or has been recalled.
          • Complete a Blood Bank Customer Feedback Form (FormINV.003)
          • Complete the reason for return and hospital storage record portion of the tag
            if applicable.
          • Notify the appropriate supplier department, i.e., BPM, Crossmatch Lab,
            Manitoba Health of the product return.
          • Return the product(s) to the blood supplier.

5.0 Reporting
      5.1 Report blood, blood components and derivatives that are returned to the blood
          supplier.
        • Complete a Blood Bank Customer Feedback Form (FormINV.003).
        • Include additional supporting documentation such as packing slips, issuing forms,
          test results, etc., when applicable.
      5.2 When returning or discarding autologous or directed units complete the
          autologous/directed form and return to the blood supplier.

                                                                                   Module	3	•	INV.010
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                    Version 2 • June 2007
6.0 Procedural Notes
       N/A




   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	         	      	       												(Senior	Management)	     	       	       		(Senior	Management)
   	         	      	       	        	        	        	
   Facility	effective	date:			__________________________________
   	         	      	       									(Date	of	implementation)




Module	3	•	INV.010
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                       INV.011		
  Selection of Blood and Blood Components for Tranfusion


1.0 Principle
      To select the appropriate blood and blood components for transfusion.

2.0 Scope and Related Policies
      2.1 Recipients shall receive ABO group specific or ABO group compatible red cells.
      2.2 When clinically significant red cell antibodies are found, or the patient’s history
          contains a record of such antibodies, red cells lacking the corresponding antigen
          should be selected for crossmatch and subsequent transfusion. Clinical circumstances
          may warrant deviation when approved by the BTS Medical Director or designate.
      2.3 Rh positive patients may receive either Rh positive or Rh negative red cells.
      2.4 Rh negative female recipients less than or equal to 45 years of age and males
          less than or equal to 18 years of age shall receive Rh negative red cells, unless the
          situation is life-threatening as determined by the attending physician/ authorized
          practitioner, and Rh negative red cells are not available.
      2.5 The facility shall have a mechanism in place to notify the BTS Medical Director
          when Rh positive red cells have been issued to an Rh negative female less than or
          equal to 45 years of age and males less than or equal to 18 years of age.
      2.6 The facility shall have a mechanism to notify the attending physician, if Rh
          positive (D pos) platelets are issued for an Rh negative female less than or equal
          to 45 years of age and males less than or equal to 18 years of age.
      2.7 The BTS Medical Director/designate will advise the attending physician/authorized
          practitioner of the need and amount of Rh Immune Globulin to administer. The
          Rh Immune Globulin should be administered within 72 hours.
      2.8 Fresh frozen plasma selected for transfusion shall be ABO compatible with the
          patient’s red cells but does not require a crossmatch.
      2.9 Cryoprecipitated AHF selected for transfusion is preferred to be ABO compatible
          with the patient’s red cells but is not required and does not require a crossmatch.
      2.10 The donor plasma in platelet components should be ABO compatible with the
           patient’s red cells, whenever possible.
          • If selecting an alternative ABO group, the amount of anti-A and/or anti-B in the
            platelet pool may affect the patient’s red cells if the patient is physically small
            and several units of platelets are transfused




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      2.11 Neonates must receive ABO compatible or plasma reduced platelets.
      2.12 Recipients to receive CMV negative red cells and platelets must include:
          • Intrauterine transfusions
          • Pediatric exchange transfusions
          • Neonates with a birth weight less than 1,200g whose mother is either CMV
            negative or CMV status unknown
          • Seronegative recipients of hematopoietic progenitor cells (HPC) from CMV
            negative donors.
          • Seronegative pregnant women
          • Seronegative recipients of organ transplants from a seronegative donor
          • Seronegative individuals who are candidates for autologous or allogeneic
            hematopoietic progenitor cell transplant
          • Patients with AIDS who are free CMV infection
          • CMV negative components for other patients shall be ordered by the attending
            physician/authorized practitioner on a case-by-case basis
      2.13 An irradiated blood component shall be labelled as “Irradiated.”
      2.14 Irradiated red cells shall have a maximum expiry time of 28 days from the time of
           irradiation or the original expiry date whichever is shorter.
          • The date of irradiation and new expiry date shall be documented on the blood
            component.
      2.15 Recipients that should receive irradiated red cells and platelets in order to reduce
           the risk of graft versus host disease should include:
          • Intrauterine transfusions
          • Exchange transfusions
          • Cellular blood components known to be from a blood relative (directed
            donation)
          • HLA selected platelets
          • Hematopoietic progenitor cell (HPC) transplant recipient (includes autologous
            and allogeneic HPC transplants)
          • Patients with hematologic disorders who will be undergoing allogeneic HPC
            transplantation imminently
          • Patients with Hodgkin’s disease
          • Patients with congenital cellular immunodeficiencies
          • Irradiated components for other patients shall be ordered by the attending
            physician/authorized practitioner on a case-by-case basis
      2.16 All neonates shall receive Group O Rh compatible red cell components.




                                                                                 Module	3	•	INV.011
2 of  • Manitoba Transfusion Quality Manual for Blood Banks                  Version 2 • June 2007
3.0 Materials
      N/A

4.0 Procedure
    4.1 Consider the following criteria when selecting blood products for transfusion:
          • Availability of autologous or directed components
          • Patient ABO/Rh type
          • Patient antibody screen result
          • Patient’s age
          • Diagnosis, if available
          • Amount and type of blood and blood components available
          • Date and/or time of intended transfusion
      4.2 Select autologous then directed blood components when available prior to
          allogenic units.
      4.3 Check the expiry date for all blood and blood components.
          • Select blood and blood components that will be indate for day of surgery or
            intended transfusion
          • Select blood and blood components with the oldest date to be used first
            whenever possible
      4.4 For red cell units:
          • Ensure the type and screen is indate unless emergency units are requested or
            autologous units will be issued
          • Select ABO/Rh specific red cell units whenever possible
          • If ABO/Rh specific red cell units are not available, select an alternate ABO/Rh
            group as outlined in Table 1
          • If Rh negative red cell units are not available, consider the patient’s age and
            gender before selecting Rh positive red cell units for an Rh negative patient,
            refer to Table 1.
          • Select Group O red cell units when the patient ABO group cannot be
            determined
          • Select Rh negative red cell units when the patient Rh type cannot be
            determined
          • Rh negative red cell units may be selected for an Rh positive patient if the units
            is near outdating
      4.5 Select phenotyped red cell units for patients with a clinically significant
          antibody(ies).




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      4.6 Select deglycerolized (frozen) red cell units for patients having special needs
          such as:
          • Multiple antibodies requiring autotransfusion
          • Clinically significant antibody to a high incidence antigen
      4.7 Select washed red cell units for patients having special needs such as
          (consultation with CBS Medical Director required):
          • Severe side effects to plasma constituents, e.g., Anti-IgA
          • Anaphylactoid reactions to plasma constituents
          • Severe urticarial reactions to plasma constituents
      4.8 Select IgA-deficient blood components for patients who have or are being
          investigated for anti-IgA antibodies (consultation with CBS Medical Director
          required).
          • Red cell units: order washed or deglycerolized (frozen) red cells
          • Platelet components: order washed platelets or platelets collected from IgA-
            deficient donors
          • Other blood components: order components collected from IgA-deficient donors
      4.9 Select irradiated cellular components (red cells, platelets, and plasma that
          has not been frozen) for patients that may be at risk for transfusion related graft
          versus host disease.
          • Intrauterine transfusions
          • Pediatric exchange transfusions
          • Exchange transfusions
          • Cellular blood components known to be from a blood relative (Directed
            donation)
          • HLA selected platelets
          • When requested by a physician/authorized practitioner
      4.10 Select CMV negative blood components (red cells, platelets) for patients
           that are immunocompromised and are CMV negative or CMV status is
           unknown (patient
           is assumed to be CMV negative).
          • Intrauterine transfusions
          • Pediatric exchange transfusions
          • Neonates with a birth weight less than 1,200g whose mother is either CMV
            negative or CMV status unknown
          • CMV negative components for other patients shall be ordered by the attending
            physician/authorized practitioner on a case-by-case basis




                                                                                   Module	3	•	INV.011
4 of  • Manitoba Transfusion Quality Manual for Blood Banks                    Version 2 • June 2007
      4.11 For plasma components:
          • All patients receiving plasma components must have two ABO/Rh
            determinations.
          • One may be from historical records.
          • If no historical records available perform a second ABO/Rh using the original
            specimen.
          • Select ABO group specific plasma components whenever possible
          • If group specific plasma components are not available, select an alternate ABO
            group as outlined in Table 2
          • Select group AB plasma components when the patient ABO group is unknown
            or cannot be determined
          • Crossmatch is not required
      4.12 For cryoprecipitate:
          • All patients receiving cryoprecipitate must have two ABO/Rh determinations.
          • One may be from historical records.
          • If no historical records available perform a second ABO/Rh using the original
            specimen.
          • Select ABO group specific cryoprecipitate whenever possible.
          • If group specific cryoprecipitate is not available select an alternate ABO group
            as outlined in Table 3.
          • Select group AB plasma components when the patient ABO is unknown or
            cannot be determined.
          • Crossmatch is not required.
      4.13 For platelet components:
          • All patients receiving platelet components must have two ABO/Rh
            determinations.
          • One may be from historical records.
          • If no historical records available perform a second ABO/Rh using the original
            specimen.
          • Select ABO group specific platelet components whenever possible.
          • If group specific platelet components are not available select an alternate ABO
            group as outlined in Table 3.
          • When Rh positive platelet concentrate is given to an Rh negative female less
            than or equal to 45 years of age or an Rh negative male less than or equal
            to 18 years of age, the administration of Rh immune globulin should be
            recommended.
          • Crossmatch is not required.




Module	3	•	INV.011
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks •  of 
Table 1: Alternate ABO/Rh for Transfusion of Red Cells
           Patient Information                    Red Cell Components
           Patient Sex Age                        1st       2nd    3rd           4th        5th
           ABO/Rh
           O Pos      M/F    Any age              O Pos        O Neg
           O Neg      M      Greater than 18      O Neg        O Pos
                      F      Greater than 45
           O Neg      M      Less than or         O Neg        O Pos*
                             equal to 18
                      F      Less than or
                             equal to 45
           A Pos      M/F    Any age              A Pos        A Neg    O Pos    O Neg
           A Neg      M      Greater than 18      A Neg        O Neg    A Pos    O Pos
                      F      Greater than 45
           A Neg      M      Less than or         A Neg        O Neg    A Pos* O Pos*
                             equal to 18
                      F      Less than or
                             equal to 45
           B Pos      M/F    Any age              B Pos        B Neg    O Pos O Neg
           B Neg      M      Greater than 18      B Neg        O Neg    B Pos* O Pos*
                      F      Greater than 45
           B Neg      M      Less than or         B Neg        O Neg    B Pos* O Pos*
                             equal to 18
                      F      Less than or
                             equal to 45
           AB Pos M/F        Any age              AB Pos A Pos          B Pos    AB Neg A Neg
           AB Neg M          Greater than 18      AB Neg A Neg          B Neg    O Neg AB Pos*
                  F          Greater than 45
           AB Neg M          Less than or         AB Neg A Neg          B Neg    O Neg      AB Pos*
                             equal to 18
                      F      Less than or
                             equal to 45
Contact BTS Medical Director anytime with any concerns.

 *    Consult	with	the	BTS	Medical	Director	(if	unable	to	contact	the	BTS	Medical	Director	or	designate,	contact	
      CBS	Accession	Lab	for	on-call	CBS	Medical	Director	or	designate).
 *    Rh	Positive	may	be	given	to	Rh	Negative	females	less	than	or	equal	to	45	years	of	age	or	Rh	Negative	
      males	less	than	or	equal	to	18	years	of	age	in	a	life	threatening	situation	which	is	determined	by	the	
      attending	physician/authorized	practitioner.
 *    The	role	of	the	BTS	Medical	Director	is	to	consult	with	the	attending	physician/authorized	practitioner	
      after	the	transfusion	to	determine	the	need	for	Rh	Immune	Globulin.	Refer	to	Module	2	MP.018	
      Emergency	Issue	of	Donor	Red	Cell	Units.


                                                                                                Module	3	•	INV.011
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NOTES:
1. If time permits, it may be possible to obtain group specific blood components from the
nearest facility before ordering from the blood supplier or selecting another blood group.
2. If Rh negative red cell products are in short supply, Rh negative males greater than 18
years of age , and females greater than 45 years of age should receive Rh positive red cell
components, providing their plasma does not contain anti-D.
3. In life-threatening situations, when transfusions cannot be delayed, the attending
physician/authorized practitioner must authorize the release of emergency Rh positive
red cell units for females less than or equal to 45 years of age or males less than or equal
to 18 years of age with unknown Rh status or are known to be Rh negative.

Table 2: Alternate ABO for Transfusion of Plasma Components
                        Patient Information             Plasma Components
                        Patient Sex Age                 1st 2nd 3rd 4th
                        ABO/Rh
                        O Pos   M/F   Any age           O      AB
                        O Neg   M     Greater than 18
                                F     Greater than 45
                        O Neg   M     Less than or
                                      equal to 18
                                F     Less than or
                                      equal to 45
                        A Pos   M/F   Any age           A      AB
                        A Neg   M     Greater than 18
                                F     Greater than 45
                        A Neg   M     Less than or
                                      equal to 18
                                F     Less than or
                                      equal to 45
                        B Pos   M/F   Any age           B      AB
                        B Neg   M     Greater than 18
                                F     Greater than 45
                        B Neg   M     Less than or
                                      equal to 18
                                F     Less than or
                                      equal to 45
                        AB Pos M/F    Any age           AB
                        AB Neg M      Greater than 18
                               F      Greater than 45
                        AB Neg M      Less than or
                                      equal to 18
                                F     Less than or
                                      equal to 45
Contact BTS Medical Director anytime with any concerns.
Module	3	•	INV.011
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks •  of 
Table 3: Alternate ABO for Transfusion of Cryoprecipitate and Platelet Products

  Patient ABO                              Platelet or Cryoprecipitate Product
                                1st                   2nd          3rd                  4th
          O                     O                      A           B                    AB
          A                     A                     AB           B*                   O*
          B                     B                     AB           A*                   O*
         AB                    AB                     A*           B*                   O*
 * If group incompatible platelets have to be distributed, choose random donor platelets
 over a single apheresis platelet when possible.

Table 4: Selection of blood components for neonates younger than four months of age
 Components                   Small Volume/ Transfusion            Exchange Transfusion
 Red Cell Units               Donated less than 14 days ago.       Must be requested from
                              Select O Negative red cells unless   Canadian Blood Services
                              mother has a significant antibody
                              that is incompatible with O Negative
                     (e.g. anti-c, anti-e).
                     If the maternal antibody screen
                     is negative, a crossmatch is not
                     required until the neonate is four
                     months of age or older.
                     If maternal clinically significant antibody is present, crossmatch
                     antigen negative red cells for the corresponding antigen with
                     mother’s plasma.
                     If a maternal specimen is not available for antibody screening,
                     an antibody screen may be tested on a neonatal specimen.
                     CMV negative red cell unit when the neonatal birth weight is
                     less than 1,200 g and the mother is CMV negative or status is
                     unknown.
 Cryoprecipitate     ABO compatible
 Plasma Components ABO compatible
 Platelet Components ABO/Rh group specific
                              Should be irradiated if newborn has had an exchange transfusion
                              and/or platelet components are from a blood relative.
                              If the neonate is Rh negative, and Rh negative platelet
                              components are not available, Rh Immune Globulin must
                              be recommended
                              CMV negative platelet when the neonatal birth weight is
                              less than 1,200 g and the mother is CMV negative or status
                              is unknown.

                                                                                    Module	3	•	INV.011
8 of  • Manitoba Transfusion Quality Manual for Blood Banks                     Version 2 • June 2007
5.0 Reporting
       N/A

6.0 Procedural Notes
       6.1 Leukocyte reduced red cells and platelet components are considered at reduced
           risk for CMV transmission.



   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	         	      	       												(Senior	Management)	     	       	       		(Senior	Management)
   	         	      	       	        	        	        	
   Facility	effective	date:			__________________________________
   	         	      	       									(Date	of	implementation)




Module	3	•	INV.011
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks •  of 
                                      INV.012		
                        Thawing Frozen Plasma Components


1.0 Principle
      To prepare frozen plasma components for transfusion.

2.0 Scope and Related Policies
      2.1 Frozen plasma components available from the blood supplier that require
          thawing before issue:
          • Fresh Frozen Plasma
          • Fresh Frozen Plasma, Apheresis
          • Frozen Plasma 24
          • Cryosupernatant Plasma
          • Cryoprecipitate AHF
      2.2 All patients receiving plasma components must have two ABO/Rh determinations.
          • One may be from historical records
          • If no historical records available perform a second ABO/Rh using the original
            specimen.
      2.3 When the patient ABO group is unknown or cannot be determined select group
          AB plasma components.
      2.4 Frozen plasma components should be thawed at 30 to 37°C.
      2.5 Thawed FFP and FP24 should be maintained at 1 to 6°C and should be transfused
          within 24 hours.
      2.6 Thawed cryosupernatant plasma should be maintained at 1 to 6°C and should
          be transfused within 24 hours.
      2.7 Thawed cryoprecipitate should be maintained at 20 to 24°C and should be
          transfused within 6 hours. If pooled, transfusion should occur within 4 hours.
      2.8 A protective over-bag shall be used for thawing frozen plasma components
          in a waterbath.
      2.9 Thawed plasma and cryoprecipitate must not be refrozen.

3.0 Materials
      37°C waterbath (circulating preferred) or automated plasma thawer
      Plastic bags (for over-wrap)
      Daily Temperature Record (FormQC.006), refer to Forms Section
      Product Thawing Form (FormQC.019), refer to Forms Section
      Towel
      Calibrated thermometer
      Timer
      Basin/sink (if applicable)

Module	3	•	INV.012
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 4
4.0 Procedure
      4.1Ensure that thawing equipment is ready for use.
      4.2 If using a waterbath:
          • check the cleanliness of the water, if the water is not clean, drain it, clean the
            waterbath and add fresh water.
          • check the water level, if the water level is low, add warm water and allow it to
            reach 37°C.
          • Adjust thermostat if necessary.
      4.3 If using a plasma thawer:
          • check the cleanliness of the water, if applicable, if the water is not clean, drain
            it, clean the water bath and add fresh water.
          • check the water level, if the water level is low, add water and allow it to reach
            operating temperature.
          • Verify that the temperature is within 30 to 37°C.
      4.4 If using a clean basin or sink:
          • Fill with warm water.
          • Adjust water temperature so that it is between 35 to 37°C. Confirm
            temperature using a calibrated thermometer
          • Leave thermometer in basin/sink until thawing is complete.
      4.5 Select the appropriate frozen plasma component (type, amount and ABO group)
          from the blood bank storage freezer.
      4.6 Remove the frozen plasma component from the box and carefully inspect for
          signs of cracking or breakage, especially around the ports at the top of the unit.
      4.7 Place each unit to be thawed in a plastic over-wrap bag refer to procedural note 6.1.
          • For cryoprecipitate, up to 2 units can be thawed in one over-wrap bag.
          • If using a plasma thawer up to 4 units of cryoprecipitate can be thawed in one
            over-wrap bag.
          • Over-wrap bags should not be reused.
      4.8 If using a waterbath or basin/sink, compress the over-wrap bag around the frozen
          plasma components to remove as much air as possible. Secure the top of the over-
          wrap bag with a clamp or a hemostat if desired.
      4.9 Read and record the temperature of the thawing device. The temperature range
          must be 30 to 37°C.
          • If using a basin/sink, the temperature must be checked every 5 minutes and
            recorded on FormQC.019.
          • Add warm water if the temperature drops below 34°C.




                                                                                  Module	3	•	INV.012
2 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                   Version 2 • June 2007
      4.10 Place the wrapped frozen plasma components into the thawing device.
          • Keep the top of the plastic over-wrap bag above the water level to prevent
            contamination of the ports.
          • If using a waterbath or basin/sink, weights may be used to keep the units
            submerged and speed thawing.
      4.11 Set a timer for approximate thawing time. If using a waterbath or basin/sink the
           approximate thawing times are:
          • For frozen plasma components: 15 minutes per unit
          • For frozen apheresis plasma: 25 minutes per unit
          • For frozen cryoprecipitate: 5 minutes
          If using a plasma thawer the approximate thawing times are:
          • For frozen plasma components: 12 minutes per unit
          • For frozen apheresis plasma: 18 minutes per unit
          • For frozen cryoprecipitate: 4 minutes
      4.12 If using a waterbath or basin/sink:
          • Gently knead the plasma component(s) throughout the thawing process to
            break up large frozen pieces or to resuspend the cryoprecipitate.
          • Check the product every 5 minutes thereafter.
          • For frozen plasma components thawing time is usually 20 to 30 minutes but is
            dependent on the size and number of units being thawed at one time.
          • For cryoprecipitate thawing time should not exceed 15 minutes.
      4.13 Remove the plasma component(s) from the thawing device as soon as thawing is
           complete. Thoroughly dry the bag and ports.
      4.14 Inspect each unit for evidence of leaking and perform a visual inspection.
          • If visual inspection criteria are not met, discard the plasma component(s).
      4.15 Attach a tag to each unit with the expiry date/time of the thawed plasma
           component(s).
          • If placing a label directly onto the unit bag, refer to procedural note 6.2.
      4.16 Transcribe the plasma component information onto the request form if
           applicable.
      4.17 Prepare and attach a compatibility tag to each unit thawed.
           • Multiple units of cryoprecipitate may be recorded on one tag.
      4.18 Store the tagged plasma at 1 to 6°C in a designated area until the plasma
           component is issued.
          Store the tagged cryoprecipitate at 20 to 24°C until the component is issued.
          • Thawed plasma components must never be refrozen




Module	3	•	INV.012
Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks • 3 of 4
        Refer to the table below for storage temperatures and shelf life.

 Thawed Blood Component                   Storage Temp                      Shelf Life
 Fresh Frozen Plasma                      1 to 6°C                          24 hrs
 Fresh Frozen Plasma                      1 to 6°C                          24 hrs
 Apheresis
 Frozen Plasma 24                         1 to 6°C                          24 hrs
 Cryosupernatant Plasma                   1 to 6°C                          24 hrs
 Cryoprecipitate AHF                      20 to 24°C                        6 hrs
                                                                            4 hrs if pooled

        4.19 Record the patient and plasma component information in the Issue/Transfusion
             Record (lab log) if applicable.
        4.20 Notify the appropriate ward when the plasma component(s) is available. Thawed
             plasma components should be transfused to the patient as soon as possible after
             thawing.

5.0 Reporting
        FormQC.019 must be kept for 5 years.
6.0 Procedural Notes
        6.1 Frozen blood and blood components are thawed in a plastic over-wrap bag to
            prevent contamination of the ports. Depending on the type of bag used for an
            over-wrap, double bagging may be desirable. Thin plastic bags are easily pierced
            by the edges of frozen units.
        6.2 When placing a label directly on the unit bag, the following criteria should be
            met whenever possible:
           • Use only labels with an approved adhesive conforming to FDA guidelines. Do
             not use scotch tape, masking tape or other adhesives that are not approved.
           • Use ballpoint pen only, DO NOT USE felt pen.




    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)




                                                                                              Module	3	•	INV.012
4 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                          INV.013		
        Tagging Blood, Blood Components and Derivatives


1.0 Principle
      To correctly tag blood, blood components and derivatives which are intended for
      transfusion/infusion.

2.0 Scope and Related Policies
      2.1 A compatibility tag shall be completed for all blood, blood components and
          derivatives issued.
      2.2 No labels shall be placed directly onto a donor unit bag unless they have an
          approved adhesive conforming to FDA (U.S. Food and Drug Administration)
          guidelines. Evidence of compliance shall be documented and kept on file.

3.0 Materials
      Request form
      Compatibility tag(s)
      Blood, blood components and derivatives

4.0 Procedure
      4.1 For each blood and blood component, prepare a tag with the following
          information:
          • Patient’s last and first name (must be identical to the names on the request
            form and specimen label)
          • Patient’s unique identifier
          • Patient ABO/Rh type
          • Donor unit ABO/Rh type
          • Donor unit number including check digit and supplier (centre) code
          • Blood or blood component type, e.g., RBC
          • Compatibility status of the donor red cell unit
          • Testing date
          • Initials of technologist tagging the donor unit(s)
      4.2 For each dose of derivative prepare a tag with the following information:
          • Patient’s last and first name (must be identical to the name on the request form)
          • Patient’s unique identifier
          • Lot number
          • Derivative type and trade name,e.g., IVIG Gammagard S/D
          • Dosage and number of vials of derivative, e.g., 20g x 3)
          • Date and initial

Module	3	•	INV.013
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
        4.3 Before attaching the tag to the blood, blood component or derivative, perform
            a thorough check as follows:
           • Perform a visual inspection of the blood, blood component or derivative.
           • Compare the patient’s last and first name, and unique identifier on the tag
             to the request form. They must be identical.
           • Ensure the blood, blood component or derivative information is identical
             to the tag.
           • Ensure the donor unit is ABO/Rh compatible with the patient.
           • Ensure the donor unit will be indate for the date of the intended
             transfusion/infusion.
        4.4 Attach the compatibility tag to the blood, blood component or derivative.
        4.5 Store the tagged blood, blood component or derivative at the appropriate
            storage temperature until the product is issued.
           Refer to procedural note 6.1

5.0 Reporting
        N/A

6.0 Procedural Notes
        6.1 Provide a separate storage area in the blood bank storage refrigerator
            designated for crossmatched blood.




    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	         	     	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	     	       	        	        	        	
    Facility	effective	date:			__________________________________
    	         	     	       									(Date	of	implementation)




                                                                                              Module	3	•	INV.013
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                     INV.013.1		
     Tagging Divided Red Cells Units for Neonatal Protocol


1.0 Principle
      To correctly label donor red cell units that are intended for transfusion to a neonate
      who is eligible for Neonatal Protocol.

2.0 Scope and Related Policies
      2.1 All neonates less than 4 months of age that have a negative antibody screen
          are eligible for the Neonatal Protocol
      2.2 To determine if a neonate is eligible for Neonatal Protocol a type and screen
          shall be performed.
      2.3 All neonates with a positive antibody screen and infants older than 4 months
          of age shall require crossmatched red cells.
      2.4 Repeat ABO/Rh and antibody screen testing are unnecessary during any single
          hospital admission if the antibody screen is negative.
      2.5 Red cells shall be Group O, Rh negative, irradiated, Anti-CMV negative and less
          or equal to 21 days old.
      2.6 A Neonatal Protocol – Divided Red Cell Product Chart Copy tag shall be
          completed for all divided red cell units issued.

3.0 Materials
      CBS Patient Report
      Neonatal Protocol–Divided Red Cell Product Chart Copy BPM 049
      Donor red cell unit(s)

4.0 Procedure
      4.1 Retrieve the CBS patient report and verify eligibility for Neonatal Protocol:
          • Verify that patient is less than 4 months of age
          • Verify that the antibody screen is negative.
      4.1 Retrieve the donor unit(s) from the blood bank storage refrigerator.
      4.1 Transcribe the following patient information from the CBS patient report to the
          attached Neonatal Protocol–Divided Red Cell Product Chart Copy tag for each
          donor red cell unit:
          • Patient’s last and first name
          • Patient unique identifier
          • Facility and ward




Module	3	•	INV.013.1
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
        4.1 Perform a thorough check of each donor unit labelled:
           • Verify the donor ABO/Rh, unit number and component code on the primary
             donor unit label is identical to the donor ABO/Rh, unit number and component
             code recorded on the tag.
           • Verify patient’s last and first name and unique identifier is identical on the CBS
             patient report and on the tag.
           • Verify donor unit is irradiated and Anti-CMV negative.
           • Verify donor unit is ‘indate’ for the date of intended transfusion.
           • Perform a visual inspection of the donor unit (INV.005).
        4.1 Place the labelled compatible donor unit(s) in the blood bank storage refrigerator
            in the area designated for crossmatched blood.

5.0 Reporting
        N/A

6.0 Procedural Notes
        N/A



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	         	     	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	     	       	        	        	        	
    Facility	effective	date:			__________________________________
    	         	     	       									(Date	of	implementation)




                                                                                            Module	3	•	INV.013.1
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
Module 4




           Module 4
                                       Module	4:	Quality	Control
                                                  Table of Contents
    Storage Equipment Standards:
    Blood, Blood Components and Derivatives ............................................QC.001 Policy
    Temperature Monitoring: Blood, Blood Component
    and Derivative Storage Equipment ................................................................... QC.001A
    Alarm System Check: Blood,
    Blood Component and Derivative Storage Equipment .................................. QC.001B
    Equipment Maintenance .................................................................................... QC.001C
    Alarm Response/Malfunction:
    Blood, Blood Component and Derivative Storage Equipment ..................... QC.001D
    Refrigerator Malfunction Instructions ...........................................QC.001D Job Aid 1
    Freezer Malfunction Instructions ...................................................QC.001D Job Aid 2
    Platelet Incubator Malfunction Instructions ................................QC.001D Job Aid 3
    Testing Equipment Standards ..................................................................QC.002 Policy
    Calibration: Incubator Waterbath/Heating Block/Plasma Thawer ............... QC.002A
    Calibration: Serologic Centrifuge ..................................................................... QC.002B
    Verification of Non Reference Thermometers ................................................ QC.002C
    Calibration: Pipette ............................................................................................. QC.002D
    Temperature Monitoring Incubator:
    Waterbath/ Heating Block/ Plasma Thawer ........................................................QC.003
    Receiving Reagents ................................................................................................QC.004
    Quality Control of Reagents: Using a Commercial QC Kit ..............................QC.005




Module	4	•	Table	of	Contents
Version 2 • June 2007                                       Manitoba Transfusion Quality Manual for Blood Banks
                                QC.001	Policy		
                     Storage Equipment Standards:
                Blood, Blood Components and Derivatives


Policies
      1 Equipment shall be qualified and validated for its intended use.
      2 Equipment used in the storage and distribution of blood, blood components and
        derivatives shall have regular documented calibration. Records of malfunction
        and repair must be kept during the working lifetime of the equipment.
      3 Equipment shall have unique identification. The unique identification number,
        e.g., serial number, facility assigned number shall be recorded on all documents
        related to the piece of equipment.
      4 The BTS /blood bank shall have a process for scheduled monitoring, maintenance
        and cleaning of equipment.
      5 The process shall include: frequency of checks, check methods, acceptance criteria
        and actions to be taken for unsatisfactory results.
          Equipment shall be calibrated before use, after repair and at prescribed intervals.
      6 The BTS/ Blood Bank shall have a written procedure outlining actions to be taken
        when the temperature of a refrigerator, freezer, incubator for platelet storage
        or plasma thawing device is outside the acceptable temperature range.
      7 Equipment used for blood, blood component or derivative storage shall be
        connected to an emergency power supply.
      8 Refrigerators, freezers and platelet incubators used for blood, blood component
        and derivative storage shall be able to maintain a temperature throughout the
        storage device that is within the range recommended by the supplier of the product.
          8.1 Refrigerators used for storage of blood and blood components shall
              be maintained at a temperature between 1 to 6°C.
          8.2 Refrigerators used for storage of derivatives shall be maintained at
              a temperature between 2 to 8°C.
          8.3 Refrigerators used for reagent or specimen storage shall be maintained
              at a temperature between 1 to 8°C.
              • Temperature checks must be performed and documented daily using
                a calibrated thermometer.
          8.4 Freezers used for storage of blood components shall be maintained
              at a temperature of -18°C or colder.
          8.5 Freezers used for reagent or specimen storage shall be maintained
              at a temperature of -18°C or colder.
              • Temperature checks must be performed and documented daily.

Module	4	•	QC.001	Policy
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
          8.6 Platelet incubators used for storage of platelets shall be maintained at
              a temperature between 20 to 24°C.
      9 Devices used for thawing of frozen blood components shall be maintained at
        a temperature of 30 to 37°C during the thawing process.
      10 Refrigerators, freezers and platelet incubators shall have alarm systems with
         audible signals.
          • Alarm activation points shall be set at temperatures that allow time for
            appropriate corrective action before the blood, blood components or
            derivatives reach unacceptable temperatures.
          • The audible alarm shall sound in a location that is continuously monitored
            or staffed so that corrective action can be taken immediately.
          • The audible alarm shall be tested weekly.
          • The audible alarm shall have a back-up power supply.
      11 Refrigerators, freezers and platelet incubators shall have the alarm activation
         points and battery back up tested quarterly.
          • Alarm activation points shall be set at temperatures that allow time for
            appropriate corrective action before the blood, blood components or
            derivatives reach unacceptable temperatures.
      12 Refrigerators, freezers and platelet incubators with a system to monitor the
         temperature continuously shall have in addition, the temperature recorded
         manually with a calibrated thermometer a minimum of once per day.
      13 Storage devices that do not have a continuous temperature-monitoring system
         shall have the temperature recorded manually with a calibrated thermometer
         a minimum of once every 4 hours.
      14 Refrigerators used for the storage of red cell components shall have a calibrated
         temperature-sensing device immersed in a fluid equal in volume and heat
         transfer characteristic to the smallest unit of donor red cells in storage. The heat
         transfer characteristics of the fluid shall be similar to blood, e.g., 10% glycerol.
      15 Equipment used for blood, blood components or derivative storage in a remote
         location outside of the BTS/blood bank shall conform to all relevant standards.
      16 The ambient temperature of open storage areas shall be recorded manually
         with a calibrated thermometer a minimum of once every 4 hours.
      17 Platelet agitators should allow for adequate mixing as well as appropriate gas
         exchange through the walls of the platelet bag.
      18 Temperature records shall be reviewed daily by a Blood Bank/BTS technologist
          • The Charge Technologist shall review temperature records monthly. The review
            shall be documented.
      19 Temperature records of refrigerators, freezers and platelet incubators shall be
         kept for a minimum of 5 years.




                                                                           Module	4	•	QC.001	Policy
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                 Version 2 • June 2007
   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	        	       	       												(Senior	Management)	     	       	       		(Senior	Management)
   	        	       	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	       	       									(Date	of	implementation)




Module	4	•	QC.001	Policy
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                      QC.001A		
                         Temperature Monitoring:
                  Blood, Blood Component and Derivative
                            Storage Equipment

1.0 Principle
      To monitor and record the temperature of blood, blood component and derivative
      storage equipment.

2.0 Scope and Related Policies
      Refer to QC.001 Policy Storage Equipment Standards: Blood, Blood Components
      and Derivatives.

3.0 Materials
      Independent calibrated thermometer for each piece of equipment
      Continuous temperature-recording chart
      Daily Temperature Record: Refrigerator (FormQC.003), refer to Forms Section
      Daily Temperature Record: Freezer (FormQC.004), refer to Forms Section
      Daily Temperature Record: Platelet Incubator (FormQC.005), refer to Forms Section
      Equipment Malfunction and Corrective Action Record (FormQC.009), refer to
         Forms Section

4.0 Procedure
      4.1 Daily: Temperature Monitoring
          4.1.1 Perform daily temperature checks of the blood, blood component and
                derivative storage equipment.
                • Read and record the temperature obtained from the continuous
                  temperature-recording device a minimum of once per day on the
                  appropriate Daily Temperature Record form.
                • Read and record the internal thermometer temperature a minimum
                  of once per day on the appropriate Daily Temperature Record form.
                • Read and record the independent calibrated thermometer temperature a
                  minimum of once per day on the appropriate Daily Temperature Record form.
          4.1.2 For open storage areas and equipment without a continuous temperature
                monitoring system:
                • Read and record the internal thermometer temperature, where applicable
                  and the independent calibrated thermometer temperature every 4 hours
                  on the appropriate Daily Temperature Record Form.
          4.1.3 Verify that the temperature has remained within the acceptable temperature
                range since the last temperature check. Refer to procedural note 6.1.
                • If the temperature is outside the acceptable range refer to QC.001D.
Module	4	•	QC.001A
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
          4.1.4 Compare the temperatures of the internal thermometer, the independent
                calibrated thermometer and the continuous temperature recording chart. If
                the temperature readings are not within 2°C of each other, refer to procedural
                note 6.2.
      4.2 Weekly: Change Continuous Temperature-Recording Chart
          4.2.1 Record the date, storage equipment identification and initial a new temperature
                chart.
          4.2.2 Remove the completed temperature chart and replace with the new chart
                according to manufacturer’s instructions.
                • Ensure the replacement chart is the correct type and size for the equipment
                  that is being monitored, and is installed correctly.
          4.2.3 Position the chart to record at the correct day and time.
                • Ensure the temperature recorded by the pen on the device is within ± 1°C
                  of the internal temperature.
          4.2.4 Review the completed chart to ensure that the temperatures recorded have
                remained within the acceptable range for the appropriate storage conditions.
          4.2.5 Document deviations outside the acceptable range on FormQC.009.

5.0 Reporting
      5.1 A blood bank/lab technologist shall review the temperature records daily.
      5.2 The Charge Technologist shall review temperature records monthly and
          document on Daily Temperature Records.
          • This review shall be documented.
      5.3 Keep temperature records for 5 years.

6.0 Procedural Notes
      6.1 Acceptable temperature ranges for blood, blood component and derivative
          storage equipment are:

 Equipment                                               Acceptable Temperature Range
 Refrigerator                                            1 to 6°C (red blood cells, thawed plasma)
                                                         1 to 8°C (reagents and specimen storage)
                                                         2 to 8°C (derivatives)
 Freezer                                                 -18°C or colder
 Platelet Incubator                                      20 to 24°C




                                                                                      Module	4	•	QC.001A
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                        Version 2 • June 2007
       6.2 If the temperature of the internal thermometer, the independently calibrated
           thermometer and the continuous temperature recording device are not within
           2°C of each other:
          6.2.1 Determine whether the chart is recording correctly (improper installation, etc.).
          6.2.2 Determine whether the digital read-out is functioning correctly, i.e., check probe
                placement, etc.
          6.2.3 Replace the internal thermometer with a calibrated thermometer. Read and
                record the temperature of the replacement thermometer after 1 hour.
          6.2.4 If unable to resolve contact Charge Technologist.




   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	        	       	       												(Senior	Management)	     	       	       		(Senior	Management)
   	        	       	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	       	       									(Date	of	implementation)




Module	4	•	QC	001A
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                       QC.001B		
                   Alarm System Check:
      Blood Component and Derivative Storage Equipment


1.0 Principle
      To ensure the alarm system of the blood, blood component and derivative storage
      equipment is functioning correctly.

2.0 Scope and Related Policies
      Refer to QC.001 Policy Storage Equipment Standards: Blood, Blood Components
      and Derivatives

3.0 Materials
      Calibrated reference thermometer
      Water
      Crushed ice
      Table salt
      Containers, suitable size
      Alarm System Check Record: Refrigerator (FormQC.007), refer to Forms Section
      Alarm System Check Record: Freezer (FormQC.008), refer to Forms Section
      Alarm System Check Record: Platelet Incubator (FormQC.018) refer to Forms Section
      Equipment Malfunction and Corrective Action Record (FormQC.009), refer to
         Forms Section

4.0 Procedure
      Alarm system checks include the following:
      • Audible alarm test
      • Alarm system battery back-up test
      • Refrigerator low and high temperature sensor activation
      • Freezer high temperature sensor activation
      • Platelet incubator low and high temperature sensor activation
      4.1 Perform an audible alarm test weekly
          4.1.1 Press “alarm test” button.
                • Disconnect if there is no “alarm test” button.
                • Some models have an indicator light as well as an audible alarm.
          4.1.2 Verify that the audible alarm sounds and indicator light flashes, if applicable.
                • Verify that the audible alarm is activated at the remote location if applicable.
          4.1.3 Record “Pass” on FormQC.007, FormQC.008 or FormQC.018 if the alarm sounds.


Module	4	•	QC.001B
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 
          4.1.4 Record “Fail” on FormQC.007, FormQC.008 or FormQC.018 if the alarm does
                not sound.
                • Monitor the temperature of the equipment every 4 hours until the alarm
                  is repaired.
          4.1.5 If equipment was disconnected to perform test, reconnect the equipment.
      4.2 Perform a test of the alarm system battery back-up quarterly.
          4.2.1 Disconnect the equipment from the main power supply, then disconnect the
                back-up power supply (if there is a separate one) connected to the alarm system.
          4.2.2 Verify that the audible and/or visual alarm sounds.
          4.2.3 Record “Pass” on FormQC.007, FormQC.008 or FormQC.018 if the alarm sounds
          4.2.4 Record “Fail” on FormQC.007, FormQC.008 or FormQC.018 if the alarm does
                not sound.
                • Replace the battery and repeat the test.
          4.2.5 Notify the Charge Technologist if the test fails after the battery has been
                replaced.
                • Record the details on FormQC.009
                • Monitor the temperature of the equipment every 4 hours until the alarm
                  system is restored.
          4.2.6 If equipment was disconnected to perform the test, reconnect the equipment.
      4.3 Perform refrigerator low and high temperature sensor activation test
          quarterly:
          The recommended low temperature set point is 1.5°C and the high temperature
          set point is 5.5°C. Refer to the manufacturer’s stated specifications if the alarm set
          points cannot be adjusted.
          4.3.1 Test for low activation:
                4.3.1.1 Verify that the alarm is switched on and the starting operating
                        temperature is 1 to 6°C.
                4.3.1.2 Place a calibrated reference thermometer into the 10% glycerol
                        container that stores the alarm temperature sensor.
                4.3.1.3 Place the container with the alarm sensor and calibrated reference
                        thermometer into a pan containing an ice and water slush at a
                        temperature of -4°C or colder.
                         • Add several spoonfuls of salt to the slush to achieve this
                           temperature, if necessary.
                4.3.1.4 Close the refrigerator door.
                4.3.1.5 Gently agitate the pan periodically until the alarm sounds.
                4.3.1.6 Record the temperature at which the alarm sounds as the low
                        activation temperature on FormQC.007.
                         • Record the internal thermometer temperature.
                         • Record the calibrated reference thermometer temperature.
                         • Temperature readings should agree within 2°C.
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2 of  • Manitoba Transfusion Quality Manual for Blood Banks                    Version 2 • June 2007
                4.3.1.7 Remove the sensor container from the ice slush.
                4.3.1.8 Repeat the test if the alarm does not sound at the expected temperature.
                4.3.1.9 Notify the Charge Technologist if repeated alarm testing fails.
                        • Contact the service company if necessary.
          4.3.2 Test for high activation:
                 4.3.2.1 Verify that the alarm is switched on and the starting operating
                         temperature is 1 to 6°C.
                 4.3.2.2 Place a calibrated reference thermometer into the 10% glycerol
                         container that stores the alarm temperature sensor.
                 4.3.2.3 Place the container with the alarm sensor and calibrated reference
                         thermometer into a pan containing warm water at a temperature of
                         12 to 15°C.
                 4.3.2.4 Close the refrigerator door.
                 4.3.2.5 Allow the fluid in the container to warm slowly, with occasional
                         agitation until the alarm sounds.
                 4.3.2.6 Record the temperature at which the alarm sounds as the high
                         activation temperature on FormQC.007.
                        • Record the internal thermometer temperature.
                        • Record the calibrated reference thermometer temperature.
                        • Temperature readings should agree within 2°C.
                 4.3.2.7 Remove the sensor container from the warm water.
                 4.3.2.8 Repeat the test if the alarm does not sound at the expected
                         temperature.
                 4.3.2.9 Notify the Charge Technologist if repeated alarm testing fails.
                        • Contact the service company if necessary.
      4.4 Perform freezer high temperature sensor activation tests quarterly
          4.4.1 Verify that the alarm is switched on and the starting operating temperature
                is colder than -20°C.
          4.4.2 Place the container with the alarm sensor and calibrated reference
                thermometer into a container of cold water.
          4.4.3 Close the freezer door.
          4.4.4 Warm the alarm probe and thermometer slowly.
                NOTE: The specific temperature of activation cannot be determined
                accurately during rapid warming.
          4.4.5 Record the temperature at which the alarm sounds as the high activation
                temperature on FormQC.008.
                • Record the internal thermometer temperature
                • Record the calibrated reference thermometer temperature
                • Temperature readings should agree within 2°C.


Module	4	•	QC.001B
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 3 of 
          4.4.6 Remove the sensor container from the cold water.
          4.4.7 Repeat the test if the alarm does not sound at the expected temperature.
          4.4.8 Notify the Charge Technologist if repeated alarm testing fails.
                • Contact the service company if necessary.
      4.5 Perform platelet incubator low and high temperature sensor activation
          tests quarterly:
          The recommended low temperature set point is 20.5°C and the high temperature
          set point is 23.5°C.
          4.5.1 Test for low activation:
                 4.5.1.1 Fill a small cup with water that is at least 1°C below the low alarm
                         setting of 20.5°C. Place in front of the unit
                 4.5.1.2 Open the RTD sensor enclosure and carefully pull the RTD sensor
                         out of the holding bracket. The temperature sensitive portion of
                         the sensor is located within 1 cm from the tip of the sensor.
                 4.5.1.3 Place a calibrated reference thermometer and the RTD sensor in
                         the cup.
                 4.5.1.4 Watch for the alarm indicator light on the temperature controller
                         to flash “LO” when the reading passes the alarm set point.
                         The audible alarm will enter the delay mode and sound after the
                         delay period has cycled (~20 sec.).
                 4.5.1.5 Verify that the audible alarm sounds.
                 4.5.1.6 Record the temperature at which the alarm indicator light first
                         flashes “LO” as the low activation temperature on FormQC.018.
                         • Record the internal thermometer temperature.
                         • Record the calibrated reference thermometer temperature.
                         • Temperature readings should agree within 1°C.
          4.5.2 Test for high activation:
                 4.5.2.1 Fill a small cup with water that is at least 1°C above the high alarm
                         setting of 23.5°C. Place in front of the unit
                 4.5.2.2 Place a calibrated reference thermometer and the RTD sensor in the cup.
                 4.5.2.3 Watch for the alarm indicator light on the temperature controller to
                         flash “HI” when the reading passes the alarm set point.
                         • The audible alarm will enter the delay mode and sound after the
                           delay period has cycled (~20 sec.).
                 4.5.2.4 Verify that the audible alarm sounds.
                 4.5.2.5 Record the temperature at which the alarm indicator light first
                         flashes “HI” as the low activation temperature on FormQC.018.
                         • Record the internal thermometer temperature.
                         • Record the calibrated reference thermometer temperature.
                         • Temperature readings should agree within 1°C.
                                                                                 Module	4	•	QC.001B
4 of  • Manitoba Transfusion Quality Manual for Blood Banks                   Version 2 • June 2007
                   4.5.2.6 Repeat testing and adjust alarm set points, if necessary, if the light
                           did not display LO or HI at the expected temperatures.
                   4.5.2.7 Remove the RTD sensor from the water and replace inside incubator.
                           Ensure the temperature returns to normal operating conditions.
                   4.5.2.8 Notify Charge Technologist if repeated alarm testing fails.
                          • Contact the service company if necessary.

5.0 Reporting
       5.1 The results of the weekly and quarterly alarm system check must be documented
           and reviewed by the Charge Technologist or designate.
       5.2 The alarm system check must be performed after receipt or repair of equipment.
           Results must be documented and reviewed by the Charge Technologist or
           designate.

6.0 Procedural Notes
       6.1 If the storage equipment has a mechanism to electronically test the high and
           low temperature sensor activation, follow the manufacturer’s instructions to
           determine the activation temperature. This should be part of weekly testing
           and cannot be used in place of the quarterly alarm system check.
       6.2 When temperatures of alarm activation are checked, the temperature change
           should occur slowly enough so that the measurements and recording are
           accurate. Too rapid a change in temperature may give the false impression that
           the alarm does not sound until an inappropriate temperature is registered.
       6.3 Alarms should sound simultaneously at the site of the refrigerator or freezer
           and at the location of remote alarms. If remote alarms are used, the alarm check
           should include a verification that the alarm sounded at the remote location.
       6.4 The amount of 10% glycerol in which the refrigerator alarm temperature sensor
           is immersed must be no larger than the smallest volume red cell component
           stored in the refrigerator.
       6.5 Platelet incubator instructions are for Helmer PC900 and PC1200 models.
           Follow the manufacturer’s instructions for all other makes/models.



   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	     											__________________________________	       __________________________________
   	        	        	       												(Senior	Management)	     	       	       		(Senior	Management)
   	        	        	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	        	       									(Date	of	implementation)




Module	4	•	QC.001B
Version 2 • June 2007                                       Manitoba Transfusion Quality Manual for Blood Banks •  of 
                                       QC.001C		
                              Equipment Maintenance


1.0 Principle
      To outline the procedures and schedules for routine equipment maintenance.
      Equipment should be cleaned using a non-corrosive surface disinfectant/
      decontaminant cleaner.

2.0 Scope and Related Policies
      Refer to QC.001 Policy Storage Equipment Standards: Blood, Blood Component
      and Derivative

3.0 Materials
      Bleach
      Non-corrosive surface disinfectant/decontaminant cleaner
      Daily Cell Washer Maintenance Record (FormQC.013), refer to Forms Section
      Weekly Cell Washer Maintenance Record (FormQC.014), refer to Forms Section
      Daily Cleaning Checklist (FormQC.015), refer to Forms Section
      Weekly Cleaning Record (FormQC.016), refer to Forms Section
      Semi-Annual Cleaning Record (FormQC.017), refer to Forms Section

4.0 Procedure
      4.1 Daily Laboratory Cleaning
          Clean all surfaces and equipment that is used daily, e.g., countertops, sinks,
          pipettors, etc.
      4.2 Daily Cell Washer Maintenance
          NOTE: Procedure may be modified to comply with manufacturer’s recommendations.
          4.2.1 Inspect tubing, liners, sealing surfaces and the collecting assembly
                for cleanliness and good condition.
                • Ensure all tubing is securely connected and free from obstruction.
                • Ensure that drain tubing is not restricted and saline waste can flow by gravity.
                • Notify supervisor if any parts appear worn or defective or any tubing
                  is cracked or leaking.
          4.2.2 Inspect stainless steel bowl.
                • Remove the rotor, distributor and bowl. Inspect the bowl for corrosion
                  and other debris.
          4.2.3 Soak the rotor and distributor in water for a minimum of one hour.
          4.2.4 Clean the inside of the bowl and liner to disinfect and remove salt build-up.
                Rinse with warm water. Reassemble. Run through one 4 WASH cycle.
                • Ensure all parts are replaced in the appropriate cell washer.

Module	4	•	QC.001C
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 1 of 4
          4.2.5 Check the volume of saline dispensed.
                • Hold a graduated cylinder under the saline dispenser in the lid. Press
                  the 2 WASH button and then the PRIME button. Discard the first volume
                  dispensed. Dispense a reasonably large volume, e.g., 42 mL. Record the
                  actual volume delivered on FormQC.013.
                • The actual volume dispensed should be 42± 1mL. Check the ‘Pass’ or ‘Fail’
                  column as appropriate.
                • If the volume delivered is unacceptable, adjust according to the
                  manufacturer’s instructions until the volume is acceptable.
                • When the volume is acceptable, record the amount dispensed in the first
                  ‘Adjust Volume’ column.
                • Repeat the volume check two more times to ensure the volume dispensed
                  is consistent. Record the volumes dispensed in the second and third
                  ‘Adjusted Volume’ columns.
                • Ensure that all three volumes delivered are within the acceptable range.
                  If not, repeat the procedure.
                • Document subsequent adjustments on the back of FormQC.013.
          4.2.6 Check the saline level in all the tubes. The saline should be visible above the
                metal bands holding the tubes. The tubes should be no more than 80% full
                and the variation between tubes should not exceed 1 cm (if applicable).
                • Place 12 empty tubes in the rotor
                • Press the ‘AUTO’ button
                • Press the ‘1 WASH’ button
                • Press the ‘START’ button
                • Press the ‘CHECK’ button. The cell washer will stop at the end of the fill
                  cycle and the saline levels can be observed.
                • If applicable, if the variation between tubes exceeds 1 cm but all other
                  criteria are met, do not put the cell washer “Out-of-Service.” Document
                  the variation by putting an (*) beside your initials in the “Levels Checked
                  By” column and record on the back of the form that the variation exceeds
                  1 cm.
          4.2.7 Initial FormQC.013.
      4.3 Weekly Laboratory Cleaning
          4.3.1 Clean the outside surfaces of balances, scales, microscopes, mixers, pipettors,
                racks, etc.
          4.3.2 Saline bottles:
                • Discard saline, rinse and refill or replace bottle.
          4.3.3 Centrifuges:
                • Remove and clean cups, buckets, and rotor
                • Clean interior surfaces.

                                                                                 Module	4	•	QC.001C
2 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                   Version 2 • June 2007
          4.3.4 Waterbaths:
                • Unplug waterbath
                • Empty water and remove grid from bottom
                • Clean cover, grid, inside of waterbath, exterior surfaces and surrounding area
                • Rinse with tap water
                • Replace grid. Fill to desired level with the type of water required by the
                  manufacturer. Replace plug in outlet.
                • Replace thermometer and check temperature setting.
          4.3.5 Date and initial FormQC.016
      4.4 Weekly Cell Washer Maintenance
          4.4.1 Decontaminate using a 1:10 dilution of bleach.
                • Place the saline intake line in the bleach.
                • Run through one 4 WASH cycle.
                • Wash one additional time and stop mid-cycle. Allow the bleach to sit
                  in the lines for ten minutes.
                    • Press the ‘AUTO’ button
                    • Press the ‘1 WASH’ button.
                    • Press the ‘START’ button
                    • Press the ‘CHECK’ button
                • After 10 minutes press the ‘START’ button.
                • Flush the lines by placing the saline intake tubing into a container of tap
                  water and run through one 4 WASH cycle.
                • Disassemble the collecting ring assembly and tubing and clean, (see the
                  Operators Manual for instructions.)
                • Place the saline intake tubing back into the saline and run through two
                  4 WASH cycles.
                • Date and initial FormQC.014.
      4.5 Quarterly Laboratory Cleaning
          4.5.1 Plasma thawers:
                • Change water in the reservoir and disinfect according to manufacturer’s
                  instructions.
                • Clean the exterior surfaces.
      4.6 Semi-annual Laboratory Cleaning
          4.6.1 Refrigerators:
                • If possible, remove product to an alternate location or to an alternate
                  shelf during cleaning.
                • Clean the shelves, interior and exterior surfaces.


Module	4	•	QC.001C
Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks • 3 of 4
                  • Replace product.
                  • Make a notation on the temperature-recording chart near the current time
                    stating that cleaning was performed. Date and initial.
           4.6.2 Freezers:
                  • Remove product and place in alternate suitable storage location at the
                    appropriate temperature.
                  • Unplug the freezer and allow to defrost.
                  • Clean the shelves, interior and exterior surfaces.
                  • Replace plug in electrical outlet.
                  • Allow temperature to reach normal operating temperature before
                    replacing product.
                  • Make a notation on the temperature-recording chart near the current time
                    stating that cleaning was performed. Date and initial.
           4.6.3 Incubators/Platelet Agitator:
                  • Turn off agitator, disable motion alarm and remove product.
                  • Clean the shelves, interior and exterior surfaces.
                  • Turn on agitator, enable motion alarm and replace product.
                  • Make a notation on the temperature-recording chart near the current time
                    stating that cleaning was performed. Date and initial.

5.0 Reporting
        N/A

6.0 Procedural Notes
        6.1 When cleaning records are complete, place the form in the corresponding
            equipment binder.
        6.2 Equipment Failure
           6.2.1 If any deviation from expected operation is identified label the equipment
                 ‘Out of Service’ and notify supervisor.
           6.2.2 Ensure all repairs and corrective action are documented and filed in the
                 Equipment Binder.


    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	    											__________________________________	   __________________________________
    	         	      	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	      	       	            	       	      	
    Facility	effective	date:			__________________________________
    	         	      	       									(Date	of	implementation)



                                                                                              Module	4	•	QC.001C
4 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                                Version 2 • June 2007
                                       QC.001D		
              Alarm Response Malfunction:
Blood, Blood Component and Derivative Storage Equipment


1.0 Principle
      To outline the procedure used in the event of alarm activation or equipment
      malfunction.

2.0 Scope and Related Policies
      Refer to QC.001 Policy Storage Equipment Standards: Blood, Blood Components
      and Derivatives.

3.0 Materials
      Equipment Malfunction and Corrective Action Record (FormQC.009) Refer to
         Forms Section
      QC.001D Job Aides 1, 2 and 3
      Shipping containers

4.0 Procedure
      4.1 Refrigerator Malfunction:
          4.1.1 Silence the alarm.
          4.1.2 Read and record the temperature of the continuous temperature recording
                device (i.e. chart recorder), the internal thermometer and the independent
                calibrated thermometer on FormQC.009.
          4.1.3 If the temperature is greater than 6°C for red cells or greater than 8°C for
                derivatives ensure that:
                • The doors are properly closed.
                • The temperature-sensing probe is properly seated in the glycerol container.
                • The power cord is plugged into the electrical outlet.
                Correct the problem and:
                • Monitor the temperature every 10 minutes.
                • Record the temperature of the refrigerator at 10, 20 and 30 minutes,
                  if necessary.
                • If the temperature returns to acceptable limits within 30 minutes record the
                  details on FormQC.009.
                • If the temperature does not return to acceptable limits within 30 minutes
                  or the refrigerator appears to be malfunctioning:
                    • Establish that the alternate blood bank refrigerator is functioning
                      properly, if available, or prepare a shipping container.
                    • Remove all products and store them in the alternate blood bank
                      refrigerator or shipping container.
                    • Refer to procedural note 6.1 and 6.2.
Module	4	•	QC.001D
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 
          4.1.4 If the temperature is less than 1°C for red cells or less than 2°C for derivatives
                or the refrigerator appears to be malfunctioning:
                • Establish that the alternate blood bank refrigerator is functioning properly,
                  if available, or prepare a shipping container.
                • Remove all products and store them in the alternate blood bank
                  refrigerator or shipping container. Refer to procedural note 6.1 and 6.2.
          4.1.5 After the transfer of blood products has been completed, notify the Charge
                Technologist and/or Maintenance/Service.
          4.1.6 Record the details of the malfunction and the corrective action on
                FormQC.009.
          4.1.7 If an alarm sounds on a refrigerator located in a remote location,
                personnel from those areas shall notify the blood bank as soon as is
                possible, who shall assess the situation as outlined above.
      4.2 Freezer Malfunction:
          4.2.1 Silence the alarm.
          4.2.2 Read and record the temperature of the continuous temperature recording
                device (i.e. chart recorder), the internal thermometer and the independent
                calibrated thermometer on FormQC.009.
          4.2.3 If the temperature is warmer than -18°C ensure that:
                • The doors are properly closed.
                • The temperature-sensing probe is properly seated in the glycerol container.
                • The power cord is plugged into the electrical outlet.
          4.2.4 Correct the problem and:
                • Monitor the temperature every 15 minutes.
                • Record the temperatures on FormQC.009.
                • If the temperature returns to acceptable limits within 30 minutes, record
                  the details on FormQC.009.
          4.2.5 If the temperature does not return to acceptable limits within 30 minutes
                and the freezer appears to be malfunctioning:
                • Establish that the alternate freezer is functioning properly.
                • Remove all products and store them in the alternate freezer.
                • Refer to procedural note 6.3 and 6.4.
          4.2.6 After the transfer of blood products has been completed, notify the Charge
                Technologist and/or Maintenance/Service.
          4.2.7 Record the details of the malfunction and the corrective action on
                FormQC.009.
      4.3 Platelet Agitator Malfunction:
          4.3.1 Establish that the backup platelet agitator is functioning properly, if
                available or prepare a shipping container.
                • Refer to procedural note 6.5.
                                                                                    Module	4	•	QC.001D
2 of  • Manitoba Transfusion Quality Manual for Blood Banks                      Version 2 • June 2007
          4.3.2 Remove the malfunctioning agitator from the platelet incubator and place
                the back-up agitator inside, if applicable.
          4.3.3 Record the details of the malfunction and the corrective action on
                FormQC.009.
      4.4 Platelet Incubator Malfunction:
          4.4.1 Silence the alarm.
          4.4.2 Read and record the temperature of the continuous recording device (i.e.
                chart recorder), the internal thermometer and the independent calibrated
                thermometer on FormQC.009.
          4.4.3 If the temperature is not between 20 to 24°C ensure that:
                • The door is properly closed.
                • The power switch is turned on.
                • The power cord is plugged into the electrical outlet.
          4.4.4 Correct the problem and:
                • Monitor the temperature every 10 minutes.
                • Record the temperatures on FormQC.009.
                • If the temperature returns to acceptable limits within 30 minutes record
                  the details on FormQC.009.
          4.4.5 If the temperature does not remain at 20 to 24°C and the platelet incubator
                appears to be malfunctioning:
                • Remove the platelets and platelet agitator from the incubator and place
                  on an available counter, or
                • Remove all platelets and store them on the backup platelet agitator if
                  available.
                • Record the ambient room temperature every 4 hours if platelets are not
                  stored in a temperature controlled environment.
                • Refer to procedural note 6.5 .
          4.4.6 After the transfer of platelets has been completed, notify the Charge
                Technologist and/or Maintenance/Service.
          4.4.7 Record the details of the malfunction and the corrective action on
                FormQC.009.
      4.5 Waterbath or Plasma Thawer Malfunction:
          4.5.1 Turn off and unplug the malfunctioning equipment.
          4.5.2 Establish that an alternate waterbath or plasma thawer is functioning
                properly, if available.
          4.5.3 Record the details of the malfunction and the corrective action on
                FormQC.009.
          4.5.4 Notify the Charge Technologist and/or Maintenance/Service.



Module	4	•	QC.001D
Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks • 3 of 
5.0 Reporting
        5.1 Corrective action taken after an alarm warning or equipment malfunction must
            be documented and reviewed by the Charge Technologist.

6.0 Procedural Notes
        6.1 If an alternate blood bank refrigerator is:
           • Not equipped with a continuous temperature-recording device, the
             temperature must be recorded every 4 hours using a calibrated thermometer.
           • Not available: Blood, blood components and derivatives can be stored in
             shipping containers for 24 hours when correctly packed as per INV.009.
          NOTE: A domestic or commercial refrigerator may not be used for interim
          storage.
        6.2 All red cell components that have been stored in a blood bank refrigerator that
            has exceeded the allowable limits of 1 to 6°C for more than 30 minutes shall be
            discarded. Notify the BTS Medical Director.
        6.3 A laboratory freezer that maintains a temperature of -18°C or colder can be used
            as an alternate freezer.
           • If it is not equipped with a continuous temperature recording device, the
             temperature must be recorded every 4 hours using a calibrated thermometer.
        6.4 All plasma or cryoprecipitate units that have been partially or entirely thawed
            because of storage in a freezer that is warmer than –18°C shall be discarded.
            Notify the BTS Medical Director.
        6.5 If a back up platelet agitator or incubator is not available, platelets may be stored
            in the CBS shipping container for up to 24 hours.
        6.6 If product is discarded, order replacement product as soon as possible.




    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)




                                                                                             Module	4	•	QC.001D
4 of  • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                 QC.001D	Job	Aid	1		
                     Refrigerator Malfunction Instructions

1. Silence the alarm.
2. Read and record the temperature of the continuous recording device (i.e. chart recorder),
      the internal thermometer and the independent calibrated thermometer on FormQC.009.
      2.1 If the temperature of the refrigerator is greater than 6o C for red cells or greater
          than 8o C for derivatives:
          • Investigate the cause of the alarm: door ajar, power cord unplugged,
            temperature probe not in glycerol container, etc.
          • Proceed to step 3.
          • If the cause is not readily identified, proceed to step 4.
      2.2 If the temperature of the refrigerator is less than 1o C for red cells or less than 2o C
          for derivatives, proceed to step 4.

3. If the door was ajar or opened for prolonged periods of time while adding or
      rotating stock or if the power cord was unplugged or temperature probe unseated:
      • Close the door and minimize entry or replace the power cord or temperature probe.
      • Monitor the temperature every 10 minutes.
      • Record the temperature at 10 minute intervals on FormQC.009.
      • If the temperature returns to acceptable limits within 30 minutes record the details
        and the corrective action taken on FormQC.009.
      • If the temperature of the refrigerator does not return to acceptable limits within
        30 minutes proceed to step 4.

4. If the refrigerator is malfunctioning:
      • Establish that the alternate blood bank refrigerator is functioning properly or
        prepare a shipping container.
      • Remove all products and store them in the alternate refrigerator or shipping container.
      • Notify the Charge Technologist of the malfunction.
      • Initiate service as directed by the Charge Technologist.
      • Record the details of the malfunction and the corrective action taken on FormQC.009.

5. If the malfunctioning refrigerator is located in a remote location:
      • Assess the problem as outlined above.
      • If the cause cannot be identified, remove all donor units and return them
        to the BTS/Blood Bank.

   EMERGENCY	PHONE	NUMBERS
   Supervisor:		_________________________		Maintenance/Service:	 _________________________

Module	4	•	QC.001D	•	Job	Aid	1
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks •  of 
                              QC.001D	Job	Aid	2		
                         Freezer Malfunction Instructions


1. Silence the alarm.
2. Read and record the temperature of the continuous recording device (i.e. chart recorder),
      the internal thermometer and the independent calibrated thermometer on FormQC.009.
      2.1 If the temperature of the freezer is -18o C or warmer and the donor units
          are still entirely frozen:
          • Investigate the cause of the alarm: door ajar, power cord unplugged,
            temperature probe not in glycerol bottle, etc.
          • Proceed to step 3.
          • If the cause is not readily identified, proceed to step 4.
      2.2 If the temperature of the freezer is warmer than –18o C and the donor units
          have been partially or entirely thawed, discard them.

3. If the door was ajar or opened for prolonged periods of time while
      adding or rotating stock or if the power cord was unplugged or
      temperature probe unseated:
      • Close the door and minimize entry or replace the power cord or temperature probe.
      • Monitor the temperature every 15 minutes.
      • Record the temperature at 15 minute intervals on FormQC.009.
      • If the temperature returns to acceptable limits within 30 minutes, record the details
        and the corrective action taken on FormQC.009.
      • If the temperature of the freezer does not return to acceptable limits within
        30 minutes proceed to step 4.

4. If the freezer is malfunctioning:
      • Establish that the alternate freezer is functioning properly.
      • Remove all donor units and store them in the alternate freezer.
      • If the alternate freezer is not equipped with a continuous temperature-recording
        device, record the temperature every 4 hours using a calibrated thermometer.
      • Notify the Charge Technologist of the malfunction.
      • Initiate service as directed by the Charge Technologist.
      • Record the details of the malfunction and the corrective action taken on FormQC.009.


    EMERGENCY	PHONE	NUMBERS
    Supervisor:		_________________________		Maintenance/Service:	 _________________________


                                                                         Module	4	•	QC.001D	•	Job	Aid	2
 of  • Manitoba Transfusion Quality Manual for Blood Banks                     Version 2 • June 2007
                                 QC.001D	Job	Aid	3		
               Platelet Incubator Malfunction Instructions


1. Silence the alarm.
2. Read and record the temperature of the continuous recording device (i.e. chart recorder),
      the internal thermometer and the independent calibrated thermometer on FormQC.009.
      2.1 If the temperature is not between 20o C and 24o C:
          • Investigate the cause of the alarm: door open, power switch turned off,
            power cord unplugged.
          • Proceed to step 3.
          • If the cause is not readily identified, proceed to step 4.

3. If the door was open, the power switch turned off or power cord unplugged:
      • Close the door and minimize entry, turn power switch on or replace the power cord.
      • Monitor the temperature every 10 minutes.
      • Record the temperature at 10 minute intervals on FormQC.009.
      • If the temperature returns to acceptable limits within 30 minutes record the details
        and the corrective action taken on FormQC.009.
      • If the temperature of the incubator does not return to acceptable limits within
        30 minutes proceed to step 4.

4. If the platelet incubator is malfunctioning:
      • Remove the platelets and platelet agitator from the incubator and place on an
        available counter, or
      • Remove all platelets and store them on the back up platelet agitator, if available.
      • Record the ambient room temperature every 4 hours using a calibrated
        thermometer.
      • Notify the Charge Technologist of the malfunction.
      • Initiate service as directed by the Charge Technologist.
      • Record the details of the malfunction and the corrective action taken on FormQC.009.




   EMERGENCY	PHONE	NUMBERS
   Supervisor:		_________________________		Maintenance/Service:	 _________________________


Module	4	•	QC.001D	•	Job	Aid	3
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks •  of 
                                QC.002	Policy		
                            Testing Equipment Standards


General
      1. Equipment shall have a unique identification number, e.g., serial number, facility
         assigned number, which shall be recorded on all documents related to the piece
         of equipment.
      2. Equipment shall be qualified for its intended use.
      3. All equipment shall be validated for its intended use.
      4. Equipment used in the collection, processing, serological testing, storage and
         distribution of blood, blood components and derivatives shall have regular
         documented calibration.
          • Equipment shall be calibrated before initial use, after repair, and at prescribed
            intervals.
      5. Records of malfunction and repair shall be kept during the working lifetime
         of the equipment plus an additional 5 years.

Incubator: Waterbath/ Heating Block/ Plasma Thawer
      1. Waterbaths and other heating devices shall be calibrated at the required
         temperature. The temperature must be checked and documented each time
         they are used.

Centrifuge
      1. The speed of rotation and the timing device of a centrifuge shall be calibrated
         on installation, following servicing and every six months thereafter.

Thermometers
      1. All thermometers (glass, digital) used in blood product storage equipment
         waterbaths and heating devices shall be verified against a National Institute
         of Standards and Technologist (NIST) calibrated reference thermometer :
          • new thermometers
          • after repair
          • every 6 months
          • or if the thermometer is used to monitor different temperature ranges.
      2. The Manitoba Transfusion Medicine Quality Improvement Working Group
         recommends the use of a digital (electronic) NIST calibrated reference
         thermometer. The reference thermometer shall be calibrated by a certified
         vendor annually.
      3. Calibration certificates and verification records must be kept for the lifetime
         of the thermometer.

Module	4	•	QC.002	Policy	
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
        4. All digital (electronic) thermometers shall have the battery replaced every 6
           months and documented on FormQC.012.



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)




                                                                                        Module	4	•	QC.002	Policy
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                              Version 2 • June 2007
                                      QC.002A		
Calibration: Incubator Waterbath/Heating Block/Plasma Thawer


1.0 Principle
      To ensure the optimal incubator temperature is achieved.

2.0 Scope and Related Policies
      Refer to QC.002 Policy Testing Equipment Standards

3.0 Materials
      Thermometer (calibrated as required)
      Calibration Record: Incubator (FormQC.010), refer to Forms Section

4.0 Procedure
      4.1 Install the equipment and calibrate as per manufacturer’s instructions before
          initial use and after repair.
          • If calibration fails notify Charge Technologist and place equipment ‘Out of
            Service’ until resolved.
      4.2 If there are no manufacturer’s instructions complete the following:
          • Turn the temperature control knob to 37°C, if applicable. If no temperature
            markings exist, turn the dial gradually and allow sufficient time for the
            temperature to equilibrate until the required temperature is reached.
          • Place a thermometer in the centre of the incubator.
          • Heating block: place thermometer into a small test tube filled with water.
          • Waterbath: place thermometer directly into water.
          • Check the thermometer every 20 minutes until the temperature reaches 37°C.
            Record temperature on FormQC.010.
          • Once the thermometer reads 37°C, adjust the temperature control knob so that
            the thermostat is no longer heating, i.e., indicator light is no longer on. Place a
            “37°C mark” where the temperature control knob is pointing.
          • Recheck the thermometer several times over the next 30 minutes to ensure the
            temperature remains at 37°C. Record the final temperature on FormQC.010.

5.0 Reporting
      5.1 Complete FormQC.010
      5.2 Calibration records should be retained for the lifetime of the incubator plus an
          additional 5 years.

6.0 Procedural Notes
      N/A
Module	4	•	QC.002A
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)




                                                                                             Module	4	•	QC.002A
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                      QC.002B		
                        Calibration: Serologic Centrifuge


1.0 Principle
      1.1 To calibrate the timer and the relative centrifugal force (rcf) or revolutions per
          minute (rpm) for a serologic centrifuge and an automatic cell washer.
      1.2 To carry out performance testing of an automatic cell washer on receipt in order
          to ensure the cell washer is functioning as expected.

2.0 Scope and Related Policies
      Refer to QC.002 Policy Testing Equipment Standards

3.0 Materials
      Centrifuge or cell washer
      Certified stopwatch
      Certified tachometer
      Test tubes
      Saline
      Plasma
      Anti-IgG
      IgG Coombs Control Cells
      PEG
      Operator’s manual for centrifuge or cell washer
      Calibration: Serologic Centrifuge (FormQC.011),refer to Forms Section

4.0 Procedure
      4.1 Install the instrument as per the manufacturer’s instructions. Ensure that the
          operator’s manual is available
      4.2 Calibrate the centrifuge (including cell washers) every 6 months on receipt or
          after service as follows:
          4.2.1Calibrate the timer. The timer must be calibrated with a certified stopwatch
               for all times routinely used.
                • Turn the timer on for, e.g., 15 seconds. Immediately start the stopwatch.
                • As soon as the centrifuge begins to decelerate, stop the stopwatch. Refer
                  to procedural note 6.1.
                • Compare centrifugation time with the stopwatch time.
                • Record the time on form.
                • Repeat the above steps for all time routinely used.
                • Timer must be within ± 5 % of the stopwatch.


Module	4	•	QC.002B
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
          4.2.2 Calibrate the revolutions per minute (rpm) using a certified tachometer.
                • Review reagent package inserts to determine the rcf or rpm for optimum
                  use. Most procedures require 900-1000 rcf or 3,200-3,400 rpm.
                • Follow the tachometer and the centrifuge manufacturer’s instructions.
                • Convert rpm into rcf, if necessary.
                • Record results.
      4.3 Performance Testing of Automatic Cell Washers
          NOTE: Variations may be required depending on the functionality of the cell
          washer purchased.
          4.3.1 To each of 12 tubes, add 2 drops of PEG, 2 drops of plasma and 1 drop of IgG
                Coombs Control Cells.
          4.3.2 Place the tubes in the tube carrier. Seat the carrier in the cell washer and
                start the wash cycle.
          4.3.3 Stop the cell washer after the addition of saline in the second cycle. Observe
                the saline level in the tubes. There should be approximately equal volumes
                of saline in all tubes. Tubes should not be more than 80% full. Record
                observations.
          4.3.4 Observe all tubes to ensure the red cells have been completely re-suspended.
                Red cells should not stream up the sides of the tubes. Record observations.
          4.3.5 Continue the wash cycle.
          4.3.6 After the addition of saline in the third cycle, stop the cell washer and
                observe the tubes as outlined in 4.3.3. Record observations.
          4.3.7 Complete the wash cycle.
          4.3.8 Inspect all tubes to ensure the saline has been completed decanted and each
                tube contains a dry cell “button”. There should be minimal cell loss and the
                cell “button” should be the same size in all tubes. Record observations.
          4.3.9 Add 2 drops of anti-IgG to each tube, centrifuge and read macroscopically.
                Ensure all tubes show the same strength of reaction ±1+ Grade.
                • If the cell washer automatically add IgG, it must be checked on receipt and
                  monthly to ensure the reagent is added uniformly and the volume added
                  meets manufacturer’s directions.
          4.3.10 Record results on FormQC.011 (under comments)
          4.3.11 Further investigation is required if :
                  • the amount of saline varies from tube to tube and cycle to cycle
                  • the cell “button” is not completely resuspended after saline addition
                  • the reaction strength is not as expected
                  • there is a significant decrease in the size of the cell “button”.




                                                                                  Module	4	•	QC.002B
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                    Version 2 • June 2007
5.0 Reporting
       5.1 Calibration records should be retained for the life of the centrifuge.
       5.2 Complete FormQC.011

6.0 Procedural Notes
       6.1 The centrifugation time includes the time of acceleration but not deceleration.
       6.2 rcf=1.12r (rpm/1000)2 where the radius in cm.
       6.3 If calibration fails refer to Troubleshooting Procedures in operator’s manual.
           If unable to resolve notify Charge Technologist and place equipment ‘Out of
           Service’ until resolved.




   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	        	       	       												(Senior	Management)	     	       	       		(Senior	Management)
   	        	       	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	       	       									(Date	of	implementation)




Module	4	•	QC	002B
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                      QC.002C		
              Verification of Non Reference Thermometers


1.0 Principle
      To verify the accuracy of the temperature indicated by the thermometer.

2.0 Scope and Related Policies
      Refer to QC.002 Policy Testing Equipment Standards

3.0 Materials
      Thermometer(s)
      National Institute of Standards and Technologist (NIST) calibrated reference
         thermometer
      Batteries
      Verification of Non Reference Thermometers Form (FormQC.012), refer to
         Forms Section

4.0 Procedure
      4.1 Each thermometer must be identified by a unique identification number.
      4.2 Inspect thermometer to be verified.
          • Glass Thermometer
             - Check for splits in liquid part of column. If splits are present refer to
               Procedural Note 6.1
          • Digital Thermometer
             - Check wire to temperature probe for cracks or wear.
             - Change battery every 6 months.
          • Document on FormQC.012.
      4.3 Place the NIST calibrated reference thermometer into the same medium in which
          the thermometer to be verified is located, i.e., 10% glycerol (fridge), distilled
          water (waterbath), air (incubator).
          • Ensure the probe is sitting at the same depth/location as the thermometer
            being verified.
      4.4 Allow thermometers to equilibrate for 5 minutes.
      4.5 Read the temperature of both the reference thermometer and the thermometer
          being verified. Record on FormQC.012.
      4.6 Determine the reading accuracy of the thermometer(s).
          • Acceptable: Thermometer reading agrees within ± 1.0 °C of the reference
            thermometer reading.
          • Unacceptable: There is a greater than ± 1.0 °C difference between the
            thermometer reading and the reference thermometer reading.
Module	4	•	QC.002C
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
        4.7 If a thermometer is to be used to monitor a range of temperatures then it must
            be verified against the reference thermometer at each temperature.

5.0 Reporting
        5.1Ensure all information is recorded on FormQC.012.
        5.2 Records shall be retained for the lifetime of the thermometer plus an additional 5
            years.

6.0 Procedural Notes
        6.1Thermometers with splits or breaks in the liquid will give inaccurate readings and
           shall not be used.
           The methods for reuniting the separation can be found in the NOTE below.
           When this occurs, document corrective action and re-verify proper temperature
           readings. If unable to reunite separation and properly verify temperatures, the
           thermometer shall be discarded.
                NOTE: Reuniting Separated Columns of Non-mercury Thermometers
                The simplest and safest method is to force the liquid down the capillary by
                using a centrifuge. Use cotton wadding at the bottom of the centrifuge cup
                to prevent damage to the bulb. Carefully insert the thermometer, turn on
                the centrifuge and, in a few seconds, all the liquid will be forced past the
                separation. Make sure the cup is deep enough so the centrifugal force is
                below the liquid column. If not, the column will split, forcing part of the liquid
                down and the remainder will be forced up, filling the expansion chamber.
                If a centrifuge is not available, hold the thermometer in an upright position
                and gently tap the stem above the separation against the palm of your hand.
                While tapping the thermometer, observe the liquid above the separation until
                it breaks away from the wall of the capillary and runs down to join the main
                column.
        6.2 Thermometers that no longer read within 1.0 °C of the reference thermometer
            should be discarded or used in a non-critical monitoring environment.
           If used for non critical monitoring, apply a label to the thermometer to indicate
           that it does not meet standards.



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)



                                                                                             Module	4	•	QC.002C
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                      QC.002D		
                                 Calibration: Pipette


1.0 Principle
      To measure the actual value of the programmed volume.

2.0 Scope and Related Policies
      Refer to QC.002 Policy Testing Equipment Standards

3.0 Materials
      Pipettor
      Distilled water
      Analytical balance
      Pipette tips
      Weigh-boats

4.0 Procedure
      4.1 Fill the programmed volume, then dispense the entire volume into a weigh-boat
          on the analytical balance.
      4.2 Read the weight on the analytical balance. Repeat this procedure 10 times.
      4.3 Determine the average weight of the programmed volume and convert it
          to volume. To convert to volume, correct the weight for specific gravity and
          temperature. Use one of the correction factors in Table 1.
           Temperature                Correction Factor
           20.0°C to 22.5°C           1.003
           23.0°C to 25.0°C           1.004
      Actual volume = average volume dispensed x correction factor.
      The resulting volume is the corrected actual volume. If the pipettor is correctly
      calibrated, the programmed volume should equal the actual volume (within the
      specifications of the pipettor).
      Calculate an average for the 10 readings of distilled water obtained from the
      balance. If the resulting average weight is within the accuracy specifications, no
      further calibration is required. If it is not within the accuracy specifications, contact
      the Manufacturer’s Technical Services Department.
      The volume dispensed should be checked by either a gravimetric or colourmetric
      method. Volume specifications are as follows:
          Precision 12.5 μL + 12 %, Accuracy 10% coefficient of variation
          Precision 25.0 μL + 5 %, Accuracy 7% coefficient of variation
          Precision 50.0 μL + 5 %, Accuracy 5% coefficient of variation
          Refer to procedural notes 6.1, 6.2 and 6.3
Module	4	•	QC.002D
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
5.0 Reporting
        N/A

6.0 Procedural Notes
        6.1 Accuracy describes how close one approaches the target value. It is defined as the
            mean of 10 measures within a defined target percentage of the desired volume.
        6.2 Precision describes how well a device reproduces its output. It is defined
            as the standard deviation of 10 measurements divided by the mean of the
            measurements multiplied by 100. Calculate and record the mean, standard
            deviation (s) and standard deviation x 2 (2s) of the weights measured converted
            to mL (multiply the weight in grams by 1000).
           Calculate and record pipette precision based on the following formula:




           If any aliquot is greater than 2s from the average volume, repeat the procedure
           described above
        6.3 Room temperature, fluid temperature, altitude and angle of the tip will influence
            the results.
        6.4 Pipettes should be re-calibrated annually unless dropped or otherwise appear
            damaged.
        6.5 If calibration fails refer to Troubleshooting Procedures in operator’s manual.
            If unable to resolve notify Charge Technologist and place equipment ‘Out of
            Service’ until resolved.




    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	         	     	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	     	       	        	        	        	
    Facility	effective	date:			__________________________________
    	         	     	       									(Date	of	implementation)




                                                                                             Module	4	•	QC.002D
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                      QC.003		
                   Temperature Monitoring Incubator:
                 Waterbath/ Heating Block/Plasma Thawer


1.0 Principle
      To monitor and record the temperature

2.0 Scope and Related Policies
      2.1 The temperature must be checked and documented daily and with each use.
      2.2 The level of water in a waterbath shall be checked before use to ensure a
          sufficient volume is present for proper incubation.
      2.3 Records of temperature checks for waterbaths and other heating devices shall be
          kept for a minimum of 5 years.

3.0 Materials
      Thermometer (calibrated as required)
      Daily Temperature Record: Incubator
         FormQC.006A Waterbath (refer to Forms Section)
         FormQC.006B Heating Block (refer to Forms Section)
         FormQC.006C Plasma Thawer (refer to Forms Section)

4.0 Procedure
      4.1 Perform a temperature check daily and each time a test is incubated or plasma is
          thawed.
          • Record the initial daily temperature on FormQC.006 A or B or C, as appropriate.
          • Ensure the temperature is within the acceptable range. Refer to procedural
            note 6.1.
          • If the temperature is outside the acceptable range, refer to procedural notes 6.2
            and 6.3.
      4.2 When incubating a test:
          • Record the temperature on the blood, blood components and derivatives
            request form or worksheet associated with the test.
      4.3 If using a waterbath, check level of water to ensure a sufficient volume (to cover
          contents of tubes) is present for proper incubation.

5.0 Reporting
      5.1 At least once a month the temperature records should be reviewed by a Charge
          Technologist and documented.
      5.2 Keep temperature records for 5 years.


Module	4	•	QC.003
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
6.0 Procedural Notes
        6.1 The acceptable temperature range for test incubation in a waterbath is 37.0°C ±
            1.0°C, or a heat block is 37.0°C ± 2.0°C or for thawing plasma is 30.0 to 37.0°C.
        6.2 When the incubator temperature is outside the acceptable range:
           • Do not use for incubating tests or thawing plasma.
           • Calibrate the incubator. Refer to QC.002A
           • Determine if the incubator is functioning properly.
           • Report problem to Charge Technologist.
        6.3 When using a heating block, use a tube size that the heating block was designed
            to hold. Follow the manufacturer’s instructions for using alternate size tubes.




    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	       	       	       												(Senior	Management)	    	    	      		(Senior	Management)
    	       	       	       	        	        	        	
    Facility	effective	date:			__________________________________
    	       	       	       									(Date	of	implementation)




                                                                                              Module	4	•	QC.003
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                      QC.004		
                                Receiving Reagents


1.0 Principle
      To visually inspect reagents on receipt

2.0 Scope and Related Policies
      2.1 All reagents shall be stored according to the manufacturer’s recommendations.
      2.2 Refrigerator or freezer compartments used to store blood, blood components and
          derivatives must be kept separate from donor and recipient specimens, reagents,
          and tissues for transplantation.

3.0 Materials
      Receipt of Reagent Record (FormQC.001), refer to Forms Section

4.0 Procedure
      4.1 Perform a visual inspection of reagent on receipt.
          • Inspect for:
              • Turbidity (maybe acceptable for some reagents. Contact manufacturer)
              • Hemolysis
              • Discoloration
      4.2 Record reagent appearance, lot number, expiry date, date received/ inspected
          and initials on Receipt of Reagent Record (FormQC.001) prepared for each
          reagent specificity. Ensure the reagent is indate. Reagents that do not meet visual
          inspection criteria must not be used for testing.
      4.3 If the visual inspection is acceptable, perform a positive and negative control on
          each lot number of reagents received. If the same lot number is received at a
          later date, the controls must be repeated. Positive and negative controls are not
          required for saline or reagent screening and panel cells.
      4.4 Check the revision date on the package insert, received with the reagent, against
          the date of the package insert in the current file. Ensure the package insert with
          the most current date is placed in the file.
      4.5 Send Receipt of Reagent Record (FormQC.001) for supervisory review and file
          along with the most current version of the package insert in an appropriate file
          that is easily accessible.
      4.6 Store reagents according to manufacturer’s instructions.

5.0 Reporting
      N/A



Module	4	•	QC.004
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
6.0 Procedural Notes
        N/A




    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	         	     	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	     	       	        	        	        	
    Facility	effective	date:			__________________________________
    	         	     	       									(Date	of	implementation)




                                                                                              Module	4	•	QC.004
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                       QC.005		
   Quality Control of Reagents: Using a Commercial QC Kit


1.0. Principle
      To confirm the reliability of the test system (includes reagents, test procedures and
      equipment) on each day of use.

2.0 Scope and Related Policies
      2.1 All reagents shall be used and stored according to the supplier’s
          recommendations and procedures.
      2.2 All antisera shall be controlled using red cells known to be positive and red cells
          known to be negative for specific antigens.
      2.3 Red cells with the weakest expression of the antigen(s) being tested should be
          used for positive controls.

3.0 Materials
      Incubator, 37°C
      Serologic centrifuge
      Block for test tubes
      If applicable:
      MTS™ Centrifuge
      MTS™ Incubator
      MTS™ Pipettor: 25μL, 50μL
      MTS™ Set-up workstation, optional
      Test tubes
      Transfer pipettes
      If applicable:
      MTS™ ID-Tips (pipette tips)
      MTS™ Package insert
      Commercial QC Kit
      ABO reagents
      Rh reagents
      AHG reagents
      IgG coated control cells
      Antibody enhancement solution
      Screen cells: 3% red cell suspension
      If applicable:
      Screen cells: 0.8% red cell suspension
      MTS™ Anti-IgG cards
      Blood Bank Quality Control Record (FormQC.002), refer to Forms Section




Module	4	•	QC.005
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
4.0 Procedure
        4.1 Perform a visual inspection of all reagents on day of use. Inspect for:
           • Turbidity (May be acceptable for some reagents. Contact manufacturer)
           • Hemolysis
           • Discoloration
        4.2 Record manufacturer, lot number, expiry date, reagent appearance, date and
            initials on worksheet (ensure all reagents are indate). Reagents that do not meet
            visual inspection criteria must not be used for testing.
        4.3 Perform Commercial QC system on reagents on day of use as outlined in the
            manufacturer’s directions.
        4.4 Record test results, date and initial on worksheet.
        4.5 If expected result(s) is/are not obtained, repeat the test(s) using a new vial of the
            reagent in question.
           • If the results are corrected, discard the initial reagent vial.
           • If the test results are not corrected, investigate equipment and/or technique.
        4.6 Record repeat test results, date and initial on worksheet.
        4.7 Report unexpected test results to the Charge Technologist or designate as per
            facility policy.
        4.8 Forward the quality control results to the Charge Technologist or designate for
            review. The review must be documented. Retain records for 5 years.

5.0 Reporting
        N/A

6.0 Procedural Notes
        N/A




    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	         	     	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	     	       	        	        	        	
    Facility	effective	date:			__________________________________
    	         	     	       									(Date	of	implementation)




                                                                                              Module	4	•	QC.005
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
Module 5




           Module 5
                              Module	5:	Supplemental	Testing	
                                   Table of Contents

    Specimen Requirements and Recommended Test Schedule –
    Manitoba Rh Program ............................................................................................. ST.001
    Neonatal Testing for HDN and Maternal RhIG Eligibility.................................. ST.002
    Weak D Typing.......................................................................................................... ST.003
    Pre-warm Technique ............................................................................................... ST.004
    ABO Problem Solving .............................................................................................. ST.005
    Rh Typing Problem Solving .................................................................................... ST.006
    Direct and Indirect Antigen Typing ...................................................................... ST.007
    Saline Addition and Replacement Technique ..................................................... ST.008
    Routine Antibody Investigation ............................................................................ ST.009
    Direct Antiglobulin Test ......................................................................................... ST.010




Module	5	•	Table	of	Contents
Version 2 • June 2007                                        Manitoba Transfusion Quality Manual for Blood Banks
                                         ST.001		
              Specimen Requirements and Recommended
                Test Schedule for Mantioba Rh Program


1.0 Principle
      To outline the specimen requirements for tests referred to the Manitoba Rh Program
      (Rh Lab).

2.0 Scope and Related Policies
      2.1 Specimens are tested from all maternal patients as part of their routine clinical care.
      2.2 Specimens are tested from the father of the fetus if the mother is Rh negative
          or possesses a clinically significant antibody.
      2.3 Cord specimens are tested from infants born to Rh negative mothers or if the
          mother possesses a clinically significant antibody.
      2.4 Additional testing is performed when required by testing protocols or when
          requested by the Manitoba Rh Consultant Medical Director or patient’s physician/
          authorized practitioner.

3.0 Materials
      Request for Pre and Post Natal Testing (Rh.101)
      Request for Cord Blood Testing (Rh.105)
      Request for Fetal Cell Detection (Rh.117)
      Manitoba Rh Program Tube Label (Rh.111)
      Requisitions
      1. Request for Pre and Post Natal Testing – must accompany specimens from the
         mother or father.
      2. Request for Cord Blood Testing – must accompany cord specimens or specimens
         from the neonate. Request form includes a peel-off label for the specimen.
      3. Request for Fetal Cell Detection – must accompany specimens when requesting
         a Kleihauer-Betke test.
      4. Manitoba Rh Program Tube Label – tube label that is used on all specimens from
         the mother or father.
      Specimens
      Mother and/or Father
      • 1 x 5 mL or 1 x 7 mL EDTA (lavender top)
      • 1 x 10 mL clotted specimen (red top – no separator gel)
      Cord Blood
      • 1 x 5 mL or 1 x 7 mL EDTA (lavender top)


Module	5	•	ST.001
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
4.0 Procedure
      4.1 Test Schedule
          4.1.1 If the mother is Rh unknown or known Rh positive and no antibodies were
                previously reported, send the following specimens:
                • Mother at initial visit
                • Mother at 28 weeks gestation
          4.1.2 If the mother is known Rh negative and no antibodies were reported
                previously, send the following specimens:
                • Mother at initial visit
                • Specimen from father of the fetus
                • Mother at 20 weeks gestation
                • Mother at 28 weeks gestation (collected prior to the administration of RhIG)
                • Mother at 34 weeks gestation
                • Mother at immediate post-partum
                • Cord blood specimen
          4.1.3 If the mother is Rh positive or Rh negative and clinically significant
                antibodies were previously reported, send the following specimens:
                • Mother at initial visit
                • Specimen from father of the fetus
                • Further specimens as recommended by the CBS Medical Director
                  or designate.
                • Mother at immediate post-partum
                • Cord blood specimen
          4.1.4 A maternal specimen is required prior to a therapeutic abortion.
          4.1.5 A post-partum maternal specimen is required following:
                • Spontaneous abortion
                • Ectopic pregnancy
                • Stillbirth
                • Intra-uterine death
                • Molar “pregnancy”
                NOTE: The facilities are responsible to collect a cord blood specimen at every
                delivery. Send the following cord blood specimens (refer to 4.1.6 and 4.1.7)
                for testing. All other cord blood specimens must be stored at the facility at
                4°C for 1 week following delivery.




                                                                                  Module	5	•	ST.001
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                  Version 2 • June 2007
          4.1.6 A cord blood specimen must be sent to the Rh Lab from infants born to
                Rh negative mothers and mothers who have clinically significant
                antibodies.
                 • Send cord blood specimen for testing
                 • Collect additional cord blood specimens for testing the cord hemoglobin
                   and bilirubin at the facility of delivery
          4.1.7A cord blood specimen may be required from jaundiced or anemic
               infants. The mother may be Rh negative or Rh positive and no
               antibodies were previously reported.
                 • Send cord blood specimen for testing
                 • Send an immediate post-partum specimen from the mother
          4.1.8The physician/authorized practitioner should request a Fetal Red Cell
               Detection (Kleihauer-Betke) test, in the following situations:
                 • A fetal death or stillbirth has occurred at or after 20 weeks gestation
                 • A maternal trauma has occurred
                 • Mother has had an invasive procedure
                 NOTE: A Kleihauer-Betke test will be performed when the fetal screen test is
                 positive on an immediate post-partum specimen from a Rh negative mother
                 who has delivered an Rh positive infant.
                 NOTE: The Kleihauer-Betke test differentiates between adult and fetal red
                 cells. It is a qualitative and quantitative test used to detect and to measure
                 the volume of fetal blood in a maternal circulation.

5.0 Reporting
       N/A

6.0 Procedural Notes
       6.1 Every effort should be made to ensure specimens are collected to allow sufficient
           time for testing to be completed and RhIG to be administered, if required, prior
           to the mother’s discharge from the facility.




   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	         	      	       												(Senior	Management)	     	       	       		(Senior	Management)
   	         	      	       	        	        	        	
   Facility	effective	date:			__________________________________
   	         	      	       									(Date	of	implementation)



Module	5	•	ST.001
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                        ST.002		
      Neonatal Testing for HDN & Maternal RhIG Eligibility


1.0 Principle
      To investigate hemolytic disease of the newborn.
      To determine maternal eligibility for Rh Immune Globulin (RhIG).

2.0 Scope and Related Policies
      2.1 Cord specimens should be collected on all Rh negative mothers and mothers with
          significant antibodies. The crossmatch lab should perform the initial investigation
          on the cord blood in order to determine the mother’s eligibility for RhIG. The
          mother’s and the cord specimens and the crossmatch lab results must be sent
          to the Manitoba Rh Program for further testing.
      2.2 Heel prick specimens from the neonate will be collected if the physician/
          authorized practitioner orders neonatal testing (ABO/Rh and DAT) or if a
          cord specimen was not collected on Rh negative or significant antibody cases.
      2.3 If requested the neonatal testing must be performed ASAP.
      2.4 Cord specimens must be washed at minimum 3 times to prevent false positives
          due to Wharton’s jelly.
      2.5 Routine testing consists of ABO/Rh and DAT on neonate specimen. A test for
          weak D (Du test) must be performed if the neonate types as Rh negative and
          the mother is Rh negative or Rh is unknown.

                                Cord/Heel Prick                    Mother
 Rh negative mother             • ABO                              Send specimen to Manitoba
                                • Rh (including Du test on         Rh Program
                                  Rh negative neonate)
                                • DAT
                                • IDAT if ordered
                                • Ensure specimen is sent to
                                  Manitoba Rh Program
 Requested by ward              • ABO
                                • Rh
                                • DAT
                                • IDAT if ordered
 Mother with clinically         • ABO                              Send specimen to Manitoba
 significant antibody           • Rh                               Rh Program
                                • DAT
                                • Ensure specimen is sent to
                                  Manitoba Rh Program

Module	5	•	ST.002
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
      2.6 Additional testing will be required if the mother has a significant IgG antibody.
      2.7 The following testing will be performed:

3.0 Materials
      EDTA cord or heel prick specimen from neonate
      Block for test tubes
      Serologic centrifuge
      Test tubes
      Pipettes
      Anti-A , anti-B and anti-D commercial reagents
      Anti-IgG
      IgG control cells

4.0 Procedure
      4.1 Check specimens against the requisition. Resolve any discrepancies before testing
          the specimen. Collect a new specimen if necessary.
      4.2 Prepare a rack and label tubes (for the baby’s specimen) with the unique
          identifier for the following tests: anti-A, anti-B, anti-D, Rh control if applicable
          and DAT. If the mother needs an ABO/Rh test or an antibody screen, follow the
          procedures in Module 2.
      4.3 Add the appropriate antisera to the anti-A, anti-B and Rh tubes.
      4.4 If using a cord specimen add some cells to a labelled tube and manually wash
          3 times. After washing make a 3% cell suspension.
      4.5 If using heel prick specimen add cells to a tube and make a 3% cell suspension.
      4.6 Add the 3 % baby’s cells to the ABO/Rh tubes and the tube labelled DAT.
      4.7 Spin ABO/Rh tubes. Read, record, and interpret results on requisition.
      4.8 Perform a DAT (if using heel prick specimen wash 3-4 times before adding AHG).
      4.9 If the neonate tests initially as Rh negative and the mother is Rh negative,
          perform a test for weak D by doing a Du test on the neonate specimen. If the
          neonate tests as weak D positive and DAT negative treat as if the neonate is Rh
          positive. If both the DAT and the Du test are positive refer out for investigation
          to Manitoba Rh Program. If the neonate is Du negative the mother is not eligible
          for RhIG.
      4.10 Report results of testing to ward.
      4.11 If the neonate is Rh positive and mother is Rh negative ensure a post-delivery
           specimen from the mother is referred out for investigation to Manitoba Rh
           Program.

5.0 Reporting
      N/A

6.0 Procedural Notes
      N/A

                                                                                   Module	5	•	ST.002
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                   Version 2 • June 2007
   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	        	       	       												(Senior	Management)	     	       	       		(Senior	Management)
   	        	       	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	       	       									(Date	of	implementation)




Module	5	•	ST.002
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                         ST.003		
                                     Weak D Typing


1.0 Principle
      To test for a weak expression of the D antigen.

2.0 Scope and Related Policies
      2.1 Testing for weak D shall be performed on any infant who types as Rh negative
          if the mother is Rh negative.
      2.2 Weak D typing shall be performed when discrepant results are obtained with
          Rh antisera.
      2.3 Test for weak D should not be performed in the following situations:
          • If the direct antiglobulin test (DAT) is positive on the red cells tested
          • If the patient has been transfused within the last 2 months with Rh positive
            cellular donor unit(s).
          • If the patient is an Rh negative mother who has delivered an Rh positive
            neonate unless there is no evidence of feto-maternal hemorrhage, e.g.,
            negative Kleihauer-Betke test).

3.0 Materials
      EDTA specimen
      Centrifuge
      Block for test tubes
      Test tubes
      Transfer pipettes
      Anti-D reagent
      Rh control if available
      Anti-IgG
      IgG coated control cells
      0.9% Saline

4.0 Procedure
      4.1 Label 2 tubes with the following:
          • Du and patient’s unique number
          • Du Control and patient’s unique number
      4.2 Add 1 drop of anti-D to the tube labelled Du.
      4.3 Add 1 drop of Rh control to the tube labelled Du control
          • Patient’s plasma may be used if Rh control is not available.
      4.4 Prepare a 3% suspension of the patient’s cells.


Module	5	•	ST.003
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
        4.5 Add 1 drop of the 3% cell suspension to each labelled tube.
        4.6 Mix the tubes.
        4.7 Incubate the tubes at 37°C for 15 minutes.
            Record the in-time and temperature on the worksheet.
        4.8 After incubation record the out-time and temperature on the worksheet. Wash
            the tubes 4 times.
        4.9 Add 2 drops of anti-IgG.
        4.10 Mix the tubes and centrifuge for 15 seconds at 3,200 ± 200 rpm.
        4.11 After centrifugation re-suspend the cells and read macroscopically.
        4.12 Grade and record results.
        4.13 Add 1 drop of IgG-coated control cells to the tube(s) with negative results.
             Centrifuge, re-suspend cells, read macroscopically and record results.
             Agglutination (2+) must be present or the test must be repeated.
        4.14 Interpret and record the Rh type.
        4.15 If a previous Rh typing result was found, compare it with the current Rh result. If
             results are discrepant refer to ST.006.
        4.16 Initial the request form.

5.0 Reporting
        For valid typing the Weak D control must be negative. Interpret results as follows:

        IAT                                                          Interpretation
        Anti-D                                 Control
        0                                      0                     Rh negative
        2+ to 4+                               0                     Rh positive
        1+                                     0                     Unable to determine.
                                                                     Additional investigation is required.
        Positive                               Positive              Unable to determine.
                                                                     Additional investigation is required.

6.0 Procedural Notes
        N/A


    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	        __________________________________
    	         	     	        												(Senior	Management)	    	        	      		(Senior	Management)
    	         	     	        	            	       	      	
    Facility	effective	date:			__________________________________
    	         	     	        									(Date	of	implementation)


                                                                                                    Module	5	•	ST.003
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                                    Version 2 • June 2007
                                         ST.004		
                                 Pre-warm Technique


1.0 Principle
      To prevent the reactivity of cold-reacting, clinically insignificant antibodies.

2.0 Scope and Related Policies
      2.1 A complete antibody investigation shall be performed before a pre-warm
          technique is used. Send the specimen to the CBS Crossmatch Laboratory.
      2.2 A pre-warm technique is done only when a previously identified cold-reactive,
          clinically insignificant antibody is present.

3.0 Materials
      EDTA specimen
      Centrifuge
      Block for test tubes
      Test tubes
      Pipettes
      Cells to be tested
      Anti-IgG
      IgG-coated control cells
      Warmed saline

4.0 Procedure
      4.1 Warm a wash bottle containing 0.9% saline to 37°C.
      4.2 Label a tube with the patient’s name and unique identifier. Place approximately
          1 mL of plasma in the tube.
      4.3 Place the tube containing the plasma into a 37°C waterbath or incubator.
      4.4 Incubate at 37°C for 5 to 10 minutes.
      4.5 Label the appropriate number of tubes with the patient’s unique identifier
          and the cell number (screening cell, panel cell, donor, etc.).
      4.6 Add 1 drop of the appropriate cell suspension into each labelled tube.
      4.7 Incubate at 37°C for 5 to 10 minutes.
      4.8 After 5 to 10 minutes incubation, add 4 drops of the warm patient plasma
          to each tube containing cells.
      4.9 Mix each tube, keeping them in the waterbath or incubator.
      4.10 Incubate the tubes at 37°C for 30 minutes. Record the in- time and temperature
           on the worksheet.
      4.11 After incubation, record the out-time and temperature on the worksheet.
           Wash the tubes 4 times using the warmed saline.
Module	5	•	ST.004
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
        4.12 Add 2 drops of anti-IgG.
        4.13 Mix the tubes immediately and centrifuge for 15 seconds at 3,200 ± 200 rpm.
        4.14 Immediately after centrifugation re-suspend the cells and read macroscopically.
        4.15 Grade and record results.
        4.16 Add 1 drop of IgG-coated cells to the tube(s) with negative results. Centrifuge,
             re-suspend cells, read macroscopically and record results.
        4.17 Report the result of the pre-warm antibody screen, crossmatch or panel.

5.0 Reporting
        5.1 Agglutination of red cells, by pre-warm technique, usually indicates the presence
            of unexpected clinically significant antibodies. In this case, the antibody screen is
            reported as positive and further antibody identification will be required.
        5.2 Tests that show no agglutination by the pre-warm technique may be reported
            as negative.

6.0 Procedural Notes
        N/A




    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

    Approved	by:	   											__________________________________	   __________________________________
    	         	     	       												(Senior	Management)	    	    	      		(Senior	Management)
    	         	     	       	        	        	        	
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                                                                                               Module	5	•	ST.004
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                         ST.005		
                               ABO Problem Solving


1.0 Principle
      To resolve ABO grouping problems

2.0 Scope and Related Policies
      2.1 ABO typing should be investigated when:
          • Discrepancies are found between the direct and reverse typings
          • Results are weak or 1+ positive in any ABO direct or reverse typing test
            (microscopic readings should only be done if mixed field agglutination is
            suspected).
          • ABO typing discrepancies are found between current and previous results.
      2.2 Previous transfusion/infusion records shall be reviewed and compared with
          current results.
      2.3 If an ABO typing problem is detected and transfusion is necessary before
          resolution, Group O blood components shall be issued until the problem
          is resolved.

3.0 Materials
      As required

4.0 Procedure
      4.1 If there is any doubt as to the identity or the quality of the specimen or if the
          group differs from the historical result, collect a new specimen and repeat the
          ABO group.
      4.2 Check the label(s) on the reagent vial(s) to ensure the correct reagents were
          used in the initial testing.
      4.3 Check the reagent(s) appearance for possible contamination.
          • Compare the reagent used with an unopened vial of the same reagent
            (and lot number if possible).
          • Use a new reagent vial if the current vial appears contaminated.
      4.4 Prepare a new 3% patient washed red cell suspension.
      4.5 Repeat the ABO testing.
      4.6 Read and record the results.
      4.7 If the problem is resolved, interpret the ABO group and record it on the
          request form.
      4.8 If the problem is not resolved, and transfusion is necessary before resolution,
          issue only Group O Rh specific red cell units until the discrepancy is resolved.
Module	5	•	ST.005
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 
      4.9 Obtain and review the patient diagnosis and transfusion and obstetrical history.
          • If the patient has been recently transfused, document the ABO group and
            number of units transfused on the request form or worksheet.
          • It may be necessary to call other facilities to obtain a thorough transfusion
            history.
      4.10 Determine the source and type of problem according to Table 1.
          • Refer to procedural notes 6.1 and 6.2.
          • Perform the method(s) applicable for resolving the problem.

 Source of ABO            Type of Problem             Applicable Method(s)               Applicable
 Problem                                              for Resolving Problem*             Procedural
                                                                                         Notes
 Reverse Group            Weaker than 1+ or           ABO Enhancement Method #1          6.3, 6.4
                          missing reaction(s)         ABO Enhancement Method #2
 Reverse Group            Unexpected or extra         Auto Control (Rh Control)          6.5
                          reaction(s)                 Saline Replacement Method
                                                      Testing Reverse Group at 37°C
 Forward Group            Weaker than 2+ or           Checking for Mixed Field           6.6, 6.7
                          missing reaction(s)         Agglutination
                                                      Testing Forward ABO Group
                                                      with Washed Patient Red Cells
 Forward Group            Unexpected or extra         Testing Forward ABO Group          6.8, 6.9
                          reaction(s)                 with Washed Patient Red Cells
 Discrepant ABO           Differs from                Resolving a Discrepancy
                          historical group            between Historical and
                                                      Current Results
*Refer to the following section for problem solving methods.
      4.11 If the problem can be resolved, determine the ABO group.
      4.12 If the problem cannot be resolved then report “ABO cannot be determined at
           this time.”
          • If transfusion is required, issue only Group O Rh compatible red cell units.
          • Consult with BTS Medical Director or designate.
          • Refer specimen to CBS for investigation.




                                                                                          Module	5	•	ST.005
2 of  • Manitoba Transfusion Quality Manual for Blood Banks                          Version 2 • June 2007
Problem Solving Methods
      A. Enhancement Method #1 (addition of more plasma)
          1. Add 2 additional drops of patient plasma to the original A1 and B cell tubes.
          2. Examine the tubes for appropriate volume and appearance.
          3. Mix and centrifuge the tubes.
          4. Re-suspend the cells and read the tubes macroscopically.
          5. If the problem isn’t resolved, incubate for 30 minutes at room temperature.
          6. Record test results and enhancement method on the request form, i.e., 4 drops
             plasma or 4 drops plasma/30 minutes as appropriate.
          7. nterpret results of enhancement method. Refer to Table 2: Interpreting Test
             Results of Enhancement Methods.
      B. Enhancement Method #2 (incubation at 4°C)
          1. Prepare an auto control tube using 4 drops of plasma and 1 drop of 3% patient
             cells.
          2. Add 2 additional drops of plasma to the original A1 and B cell reverse grouping
             tubes.
          3. Mix and incubate the tubes for 15 to 60 minutes at 4°C.
          4. After incubation, centrifuge the tubes.
          5. Re-suspend the cells. Read the tubes macroscopically for direct agglutination.
          6. Record test results, and enhancement method on the request form, i.e. 6 drops
             plasma/4°C.
          7. Interpret results of enhancement method. Refer to Table 2: Interpreting Test
             Results of Enhancement Methods.




Module	5	•	ST.005
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 3 of 
Table 2: Interpreting Test Results of Enhancement Methods

 Enhancement                 Expected A1 and           Auto     Next Step
 Method                      B cell reactions          Control
                             enhanced to 1+            Reaction
                             or stronger
 #1 IS                       Yes                       N/A        Interpret and report ABO.
 #1 IS                       No                        N/A        Incubate for 30 minutes at room
                                                                  temperature.
                                                                  Step 5, Enhancement Method #1.
 #1 30 minutes at RT         Yes                       N/A        Interpret and report ABO
 #1 30 minutes at RT         No                        N/A        Perform Enhancement Method #2
 #2 15 minutes at 40C        Yes                       Negative   Interpret and report ABO.
 #2 15 minutes at 40C        No                        Negative   Report “ABO cannot be
                                                                  determined at this time.” Consult
                                                                  with CBS Crossmatch Laboratory.
                                                                  Refer to procedural note 6.4.
 #2 15 minutes at 40C        Both A1 and B cells       Positive   Refer to Table 3: Interpreting Test
                             are positive                         Results of Auto Control
IS – Immediate Spin
RT – Room Temperature

      C. Auto Control
Table 3: Interpreting Test Results of Auto Control

 Auto Control          Additional Patient Information             Next Step
 Reaction
 Positive              Patient history of protein                 Suspect rouleaux.
                       abnormality, e.g., multiple myeloma        Perform saline replacement on
                       Patient has received an infusion           the original A1 cell, B cell and
                       of dextran (may increase plasma            auto control tubes.
                       protein).                                  Refer to Saline Replacement
                                                                  Method.
 Positive              Patient diagnosis is viral or              Suspect an auto anti-I.
                       mycoplasma pneumonia, or cold              Retest the reverse group at 37°C.
                       agglutinin disease.
                                                                  Refer to Testing the Reverse
                                                                  Group at 37°C.
 Negative              Patient’s forward group types as           Suspect an anti-A1. Report “ABO
                       Group A or AB with an unexpected           cannot be determined at this
                       reaction with the A1 cells.                time.” Send out specimen to
                                                                  CBS Crossmatch Lab for further
                                                                  investigation.


                                                                                          Module	5	•	ST.005
4 of  • Manitoba Transfusion Quality Manual for Blood Banks                          Version 2 • June 2007
      D. Saline Replacement Method
          1. Re-centrifuge the original tubes for A1 and B cells.
          2. Remove the supernatant leaving the red cell “button” undisturbed.
             Use a pipette or a vacuum aspiration device.
          3. Add 2 drops of saline to each tube.
          4. Examine the tubes for appropriate volume and appearance.
          5. Mix and centrifuge the tubes.
          6. Re-suspend the cells and read the tubes.
          7. Record and interpret test results on request form. Indicate that a saline
             replacement was performed, i.e., “SR”. Refer to Table 4.

Table 4: Interpreting Test Results of Saline Replacement
                        Expected A1 and B cell
 Auto Control
                        reactions are 1+ or              Next Step
 Reaction
                        stronger
 Negative               Yes                              Interpret and report the ABO.
 Negative               No                               Perform Enhancement Method #1.

                                                         Suspect an auto anti-I.
 Positive               Both A1 and B cells are
                                                         Retest the reverse group at 37°C.
                        positive and patient is not
                        Group O                          Refer to Testing the Reverse Group at
                                                         37°C. Refer to procedural note 6.5.

      E. Testing Reverse Group at 37°C
          1. Add 1 drop of A1 and B cell reagent to the appropriate labelled test tube and
             incubate at 37°C for 5 minutes.
          2. Add approximately 0.5 mL of patient plasma to a tube labelled with the
             patient’s unique identifier and incubate at 37°C for 5 minutes.
          3. Add 2 drops of the pre-warmed plasma to the pre-warmed tubes containing A1
             and B cells.
          4. Examine the tubes for appropriate volume and appearance.
          5. Mix and centrifuge the tubes.
          6. Re-suspend the cells and read the tubes macroscopically.
          7. Record and interpret test results on the request form. Indicate method, i.e.,
             reverse group at 37°C.
          8. If the expected A1 and B cell reactions are 1+ or stronger interpret and report
             the ABO.
          9. If the expected A1 and B cell reactions are weaker than 1+ report “ABO cannot
             be determined at this time.” Consult with the CBS Crossmatch Laboratory.
             Refer to procedural note 6.5.
Module	5	•	ST.005
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks •  of 
       F. Checking for Mixed Field Agglutination
          1. Read the anti-A and/or anti-B tubes macroscopically. Observe for cloudiness of
             the supernatant. Read microscopically to check for mixed field agglutination.
             Refer to Table 5.
Table 5: Reporting Mixed Field Agglutination

 Mixed Field            Patient
 Agglutination          Transfusion                  Next Step
 Observed?              History
                        Patient has been
                                                     Obtain the transfusion history directly from
                        transfused non-
                                                     the facilities involved. Consult with the CBS
 Yes                    group specific red
                                                     Crossmatch Laboratory before transfusing, if
                        cells in the past 3
                                                     applicable.
                        months.

                                                     Review patient diagnosis for a possible
                        Patient has not              explanation. Refer to procedural note 6.7.
 Yes                    been transfused in           Report “ABO cannot be determined at this
                        the past 3 months.           time”. Send out specimen to CBS Crossmatch
                                                     Laboratory for further investigation .

                                                     Repeat ABO forward group on a 3%
                                                     suspension of washed patient’s red cells. Refer
 No                     N/A
                                                     to Testing Forward ABO Group with Patient’s
                                                     Washed Red Cells. Refer to procedural note 6.6.

       G. Testing Forward ABO Group with Patient’s Washed Red Cells
          1. Prepare a 3% saline suspension of washed (3x) patient red cells. Use pre-
             warmed saline (37°C) to wash cells if a cold-reactive agglutinin is suspected.
          2. Repeat the ABO forward group on the 3% washed red cell suspension.
          3. Record the second set of ABO test results on the request form.
             • Indicate that the patient’s red cells have been washed or if applicable,
               that patient’s red cells have been washed with pre-warmed saline (37°C).
          4. If the expected anti-A and anti-B reactions are 2+ or stronger, interpret
             and report the ABO.
          5. If the expected anti-A and anti-B reactions are weaker than 2+ report “ABO
             cannot be determined at this time.” Consult with the CBS Crossmatch
             Laboratory before transfusing. Refer to procedural note 6.8.




                                                                                        Module	5	•	ST.005
 of  • Manitoba Transfusion Quality Manual for Blood Banks                        Version 2 • June 2007
      H. Resolving a Discrepancy Between Historical and Current Results
          1. Ensure that the specimen does not have a secondary label placed over the
             primary label.
             • If it does, remove the secondary label and check the primary label
               information against the request form.
             • If the information on the primary label differs from that on the secondary
               label, recollect the specimen and repeat the testing.
          2. Ensure that the results have been recorded for the correct patient. If not,
             repeat the ABO testing for all patients tested at the same time to determine if
             a mix-up has occurred.
          3. Ensure that the information on the specimens matches the information on the
             request form. If not, recollect the specimen and repeat the testing.
          4. If the repeated results are the same as the historical results, retest all specimens
             from all patients tested at the same time to determine if a testing mix-up has
             occurred.
          5. If the repeated test results are the same as the previous results, recheck the
             historical test results, if possible.
             • If the historical grouping was transcribed or interpreted incorrectly, report
               the results obtained from the current specimen.
             • If the historical grouping was interpreted and transcribed correctly, consider
               the following:
             • The historical records may be incorrect.
             • The patient may not be the same person as described in the historical record.

5.0 Reporting
          N/A

6.0 Procedural Notes
      6.1 ABO discrepancy due to procedure or technique, possible causes:
          • Procedural errors
          • Antisera not added or wrong antisera used
          • Cell suspension too strong
          • Centrifugation insufficient or too strong
          • Red cell “button” re-suspended too vigorously, dispersing small agglutinins
          • Failure to re-suspend entire red cell “button”
          • Inappropriate reading (microscopic)
      6.2 To identify the source of an ABO problem, i.e., forward versus reverse group,
          consider the following:
          • ABO reactions are usually strong. Weak reactions should be questioned and
            further investigated.
          • Problems in reverse group are more common.

Module	5	•	ST.005
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks •  of 
          • More than one problem may exist, e.g., a weak subgroup of A may have Anti-A1
            in the plasma.
      6.3 Reverse group: weak (<1+) or missing reaction(s), possible causes:
          • If the patient is elderly or immune suppressed, suspect hypogammaglobulinemia
            or aggammaglobulinemia.
          • Neonatal patients sometimes do not demonstrate anti-A and/or anti-B until 4-6
            months of age.
      6.4 Expected reactions with A1 and/or B cells are weaker than 1+ after Enhancement
          Method #2:
          • Patient may have received a bone marrow or hematopoetic stem cell transplant,
            e.g., a Group A patient who has received a Group O transplant will type as a
            Group O in the forward group but may not have an anti-A. In this case, follow
            the transfusion protocol of the facility where the transplant occurred.
      6.5 Reverse group: unexpected or extra reaction(s), possible causes:
          • Rouleaux
          • Cold reactive antibody (if the auto control is positive, then the antibody is
            probably an auto anti-I reacting with the I antigen present on the A1 and B cells)
          • Anti-A1
      6.6 Forward group: weaker than 2+ or missing reaction(s), possible causes:
          • Mixed field agglutination
          • Excess blood group substance in patient plasma causing neutralization of anti-A
            and/or anti-B, e.g., mucin producing adenocarcinomas
      6.7 Forward group: mixed field agglutination, possible causes:
          • Recent transfusion of non-group specific red cells
          • Feto-maternal hemorrhage
          • Patients who have received an allogeneic bone marrow or hematopoetic stem
            cell transplant may give mixed field results during the transplant period. For
            some patients, the mixed field will remain indefinitely
          • Weak subgroups, e.g. A3 of A and other subgroups of A or B may not react as
            mixed field with anti-A and/or anti-B
          • Altered expression of A and/or B antigens due to disease. When the current
            ABO group does not agree with the historical group, the patient diagnosis may
            be the explanation for the change.
          • Polyagglutinable red cells such as Tn-activated cells. The reverse group fails to
            confirm the forward group.
          • Twin chimerism (very rare)




                                                                                   Module	5	•	ST.005
8 of  • Manitoba Transfusion Quality Manual for Blood Banks                   Version 2 • June 2007
       6.8 Forward group: unexpected or extra reaction(s) resolved by washing patient’s red
           cells, possible causes:
          • Strong cold autoagglutinin
          • Rouleaux
          • Wharton’s jelly (cord blood specimens)
          • Fibrin, contamination with other debris
       6.9 Forward group: unexpected or extra reaction(s), other causes:
          • Antibody-sensitized red cells may agglutinate with ABO antisera due to the
            colloidal nature of the reagents
          • Human source ABO antisera may contain antibodies to a low incidence antigen
          • Antibodies in patient plasma against dyes or drugs in ABO antisera may be
            present
          • Acquired B antigen (rare condition reported only in group A1 patients)
          • Polyagglutinable red cells may agglutinate with human source anti-A, anti-B
            and/or anti-A, B.



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Module	5	•	ST.005
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks •  of 
                                         ST.006		
                                 Rh Problem Solving


1.0 Principle
      To resolve Rh typing problems

2.0 Scope and Related Policies
      2.1 Rh typing shall be investigated when:
          • The Rh control test is positive
          • Results are weak or 1+ positive with anti-D reagent.
          • Rh typing discrepancies are found between current and historical results.
      2.2 Historical transfusion/infusion records shall be reviewed. Historical results must
          be compared with current results.
      2.3 If an Rh typing problem is detected and transfusion is necessary before resolution,
          Rh negative blood components shall be issued until the problem is resolved.

3.0 Materials
      EDTA specimens
      Other materials as required

4.0 Procedure
      4.1 If there is any doubt about the identity or the quality of the specimen, collect
          a new specimen and repeat the Rh typing.
      4.2 Check the label on the vial(s) of reagent to ensure that the correct reagent was
          used.
      4.3 Recheck the reagent’s appearance for possible contamination. Use a new vial(s)
          of reagent if the current vial appears contaminated.
      4.4 Prepare a new 3% patient washed red cell suspension.
      4.5 Repeat the Rh typing on the new 3% patient red cell suspension.
      4.6 Read and record the results.
      4.7 If problem is resolved, interpret the Rh group and record it on the request form
          (refer to procedural note 6.1).
      4.8 If problem is not resolved and transfusion is necessary before resolution, select
          Rh negative donor units.
      4.9 Obtain and record the patient’s diagnosis and transfusion and obstetrical history.
          If the patient has been recently transfused document the Rh group and the
          number of units transfused on the request form.



Module	5	•	ST.006
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 4
      4.10 Determine the source and type of problem according to the following table.
           Perform the methods applicable for resolving the problem:

 Anti-D                    Rh Control Next Step
 Weak or 1+                Negative   Review diagnosis and transfusion history. Look for
                                      mixed field agglutination. Refer to procedural note
                                      6.2.
                                            If the patient was transfused in the last 3 months with
                                            blood of a different Rh type, record the historical
                                            grouping on the current record with an explanation
                                            for the discrepancy.
                                            If the patient has not been transfused in the last 3
                                            months, perform a weak D typing test.
 Positive                  Positive         Wash the cells 4 times with saline. Refer to procedural
                                            note 6.3. Repeat the Rh typing on the 3% washed
                                            cells.
                                            If the control is negative, report the Rh typing. Refer
                                            to procedural note 6.4.
                                            If the control is still positive, perform a Direct
                                            Antiglobulin Test and select Rh negative donor units.
 Discrepancy                                Review the transfusion, obstetrical and medication
 (If the previous Rh                        history. Look for mixed field agglutination.
 typing does not                            If the patient was transfused in the last 3 months with
 agree with the                             blood of a different Rh type, record the historical
 current test result)                       grouping on the current record with an explanation
                                            for the discrepancy.
                                            If the patient has not been transfused in the last 3
                                            months and the discrepancy cannot be resolved by
                                            testing for the weak D antigen, recollect a specimen
                                            and repeat the test. Refer to procedural notes 6.5 and
                                            6.6.

      4.11 Report the results (include all methods used) and the conclusion of the
           investigation on the request form.

5.0 Reporting
      N/A




                                                                                        Module	5	•	ST.006
2 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                        Version 2 • June 2007
6.0 Procedural Notes
      6.1 If the discrepancy has been resolved, one of the following could have caused the
          discrepancy:
          • Procedural errors
          • Antiserum not added, or wrong one used
          • Cell suspension too strong
          • Centrifugation insufficient or excessive
          • Tube shaken too vigorously and small agglutinates were dispersed
          • Failure to re-suspend entire cell “button”
          • Reading microscopically when antisera instructions indicate macroscopic
            reading.
      6.2 Possible causes for mixed field agglutination:
          • Recent transfusion with different Rh donor unit
          • Contaminated specimen
          • Unusual Rh phenotype that may or may not be associated with production of
            Rh alloantibodies
          • Large feto-maternal bleed
          • Genetic anomalies such as dispermy and chimerism.
      6.3 If a cold agglutinin is suspected, an antibody investigation is required.
      6.4 Positive control may be due to:
          • Rouleaux
          • Strong autoagglutinins
          • Positive Direct Antiglobulin Test (DAT).
      6.5 If the result on the new specimen is the same as the result on the discrepant
          specimen, consider the following possibilities:
          • A technical or clerical error on the previous specimen. If possible, review the
            historical test results to ensure that an interpretation error did not occur
          • Patient is using another person’s identification
          • Loss of antigen due to disease. Check the diagnosis. Adsorption and elution
            with anti-D may be necessary to confirm the Rh as positive.
      6.6 If the result on the new specimen is different from the result on the discrepant
          specimen and matches the historical record, consider the following:
          • Error in collection of discrepant specimen
          • Report the result that agrees with the historical record
          • Check into the possibility that other patients are involved, e.g., another patient
            specimen collected close to the same time by the same phlebotomist
          • Complete an incident report and submit to the Charge Technologist.


Module	5	•	ST.006
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 3 of 4
        6.7 Resolving a Discrepancy Between Historical and Current Results
           6.7.1 Ensure that the specimen does not have a secondary label placed over the
                 primary label. If it does, remove the secondary label and check the primary
                 label information against the request form. If the information on the
                 primary label differs from that on the secondary label, recollect the specimen
                 and repeat the testing.
           6.7.2 Ensure that the results have been recorded for the correct patient. If not,
                 repeat the Rh testing for all patients tested at the same time.
           6.7.3 Ensure that the information on the specimen matches the information on
                 the request form. If not, recollect the specimen and repeat the testing.
           6.7.4 If the repeated results are the same as the historical results, retest all
                 specimens from all patients tested at the same time to determine if a testing
                 mix-up has occurred.
           6.7.5 If the repeated test results are the same as the previous results, recheck the
                 historical test results, if possible. If the historical grouping was transcribed
                 or interpreted incorrectly, report the results obtained from the current
                 specimen. If the historical grouping was interpreted and transcribed
                 correctly, consider the following:
                • The historical records may be incorrect.
                • The patient may not be the same person as recorded on the historical
                  record.



    Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

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                                                                                               Module	5	•	ST.006
4 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                        ST.007		
                        Direct and Indirect Antigen Typing


1.0 Principle
      1.1 After an antibody has been identified, it is necessary to test the patient’s
          pre-transfusion red cells to determine if they lack the corresponding antigen.
          If pre-transfusion red cells are unavailable, consult the Charge Technologist.
      1.2 All red cells used for transfusion to a patient with a history of or a current
          clinically significant antibody must be negative for the corresponding antigen.
          The presence of the corresponding antigen is determined with the use of
          commercial antisera.
      1.3 In direct antigen typing, specific antisera will agglutinate red cells that have the
          corresponding antigen. Agglutination will occur after a short incubation period
          either at 4°C, room temperature or 37°C depending on the antiserum being used.
      1.4 In indirect antigen typing, specific antisera will agglutinate red cells that have
          the corresponding antigen. Agglutination will be demonstrated by IAT.

2.0 Scope and Related Policies
      2.1 Patient red cells shall be antigen typed for the corresponding antigen when
          an antibody is identified in their plasma.
          • The absence of the antigen on the patient’s red cells indicates the presence
            of an alloantibody.
          • The presence of the antigen on the patient’s red cell indicates the presence
            of an autoantibody.
      2.2 Donor red cells that have been confirmed antigen negative for the corresponding
          clinically significant antibody(ies) must be crossmatched if the patient has a
          known (reactive or non-reactive) clinically significant antibody(ies) and the
          corresponding antisera is available.
          • If the patient’s clinical condition does not allow for the delay to receive
            confirmed antigen negative units, crossmatched compatible units may be issued.
            Segments from the donor units should be kept for antigen typing, sent to CBS if
            applicable.
      2.3 It is not necessary to antigen type donor units for crossmatching when the patient
          has a known (reactive or nonreactive) clinically insignificant antibody(ies).




Module	5	•	ST.007
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 4
3.0 Materials
      Centrifuge or cell washer
      37°C waterbath or incubator
      Work block(s)
      Worksheet
      Test tubes
      Transfer pipettes
      Reagent red cell suspension
      Commercial antisera
      Anti-IgG
      IgG Coombs Control Cells

4.0 Procedure
      4.1 Controls
          4.1.1 A positive and negative control must be done with each batch of tests.
                • The batch must not be greater than 24 tests, including the controls.
                • If two lot numbers of antisera are used for a batch, each must have
                  a set of controls.
          4.1.2 The positive control cell must be a single dose antigen for the antibody
                being tested. For some antisera, dosage is not applicable, e.g., P1, Lea or
                Leb. In these cases the positive control can be any cell that is positive for
                the antigen. The expression of the P1 antigen must not be strong.
          4.1.3 The negative control must lack the antigen corresponding to the antibody.
          4.1.4 Reagents that are cloudy or contain particulate matter are acceptable for
                use providing the controls are valid.
          4.1.5 Red cells with a positive DAT may spontaneously agglutinate and cause
                false positive results in direct and indirect antigen typings.
      4.2 Label each tube with the patient or donor ID and the name of the antigen
          being tested.
      4.3 Record the following on the worksheet:
          • Identification of cell being tested
          • Identification of antisera being tested
          • Antisera manufacturer, lot number and expiry date
          • Visual inspection of the antisera
          • Test method
          • Identification of control cells, e.g., lot and cell number
          • Phenotype of control cells
          • In-time/temperature
          • Initials



                                                                                    Module	5	•	ST.007
2 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                    Version 2 • June 2007
      4.4 Prepare a suspension of the cells to be tested according to the manufacturer’s
          directions for the specific antisera.
      4.5 Add antisera to the labelled tube according to the manufacturer’s directions for
          the specific antisera.
      4.6 Add donor or patient cells according to the manufacturer’s directions for the
          specific antisera.
      4.7 Mix well and complete testing according to manufacturer’s directions.
      4.8 Record “set-up by” and the “in-time”/temperature.
      4.9 Record the “out-time”/temperature. Typing performed by immediate spin will not
          have an “out-time”/temperature.
      4.10 Record “read by,” gently resuspend tubes, grade and record results.
      4.11 Control all negative antiglobulin tests by adding 1 drop of IgG control cells.
          • Centrifuge and resuspend tubes. Grade and record results
          • If IgG control cells show less than a 2+ reaction, the test is invalid and must be
            repeated.

5.0 Reporting
      5.1 Agglutination of red cells in the presence of the specific antiserum is a positive
          reaction and indicates the presence of the corresponding antigen on the red cells.
      5.2 The absence of agglutination is considered to be a negative reaction, indicating
          the absence of the corresponding antigen on the red cells.
      5.3 The positive control must be 2+ or greater and the negative control must be non-
          reactive or the test is considered invalid and must be repeated.
          • 1+ reaction with the positive control may be acceptable if the result compares
            to the initial QC testing on-receipt.
      5.4 If the patient’s red cells test positive for the antigen for which it appears they
          have the corresponding antibody, the results must be investigated.
      5.5 If the patient has been transfused or pregnant in the previous 3 months
          phenotyping results must be interpreted with caution.

6.0 Procedural Notes
      6.1 Mixed field reactions may result if the patient has been transfused in the previous
          3 months. Consult Charge Technologist before reporting results.
      6.2 Patients with Lewis antibodies must be phenotyped for Lea and Leb.
          Do not phenotype pregnant patients for Lea or Leb.




Module	5	•	ST.007
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 3 of 4
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    	       	       	       									(Date	of	implementation)




                                                                                               Module	5	•	ST.007
4 of 4 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                        ST.008		
              Saline Addition and Replacement Technique


1.0 Principle
      The saline addition or replacement technique is used to differentiate rouleaux from
      true agglutination. The procedure may be used with any test performed at 4°C,
      room temperature or 37°C by direct agglutination.

2.0 Scope and Related Policies
      2.1 The saline addition or replacement technique is performed when rouleaux is
          suspected in tests performed at 4°C, room temperature or 37°C. Rouleaux will not
          be observed in tests performed using IAT.
      2.2 Rouleaux will disperse with the addition of or replacement with saline, whereas
          true agglutination will remain. Tests that are negative following saline addition
          or replacement are considered to be negative.

3.0 Materials
      Centrifuge or cell washer
      Worksheet
      Transfer pipettes
      0.9% saline

4.0 Procedure
      4.1 Saline addition technique:
          • Add one drop of saline to the tube, mix gently
          • Centrifuge for 15 seconds at 3,400 ± 200 rpm
          • Re-suspend each tube and read macroscopically
          • Grade and record results.
      4.2 If the rouleaux persists, use the saline replacement technique:
          • Centrifuge the tube(s) for 15 seconds at 3,400 ± 200 rpm
          • Remove the plasma with a pipette
          • Replace plasma with an equal volume of saline
          • Mix the tubes and centrifuge for 15 seconds at 3,400 ± 200 rpm
          • Re-suspend each tube and read macroscopically
          • Grade and record results.




Module	5	•	ST.008
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
5.0 Reporting
        5.1 Tests that are non-reactive following saline addition or replacement are
            considered to be negative.
        5.2 Tests that are reactive following saline addition or replacement are considered
            to be positive. Further investigation is required.

6.0 Procedural Notes
        6.1 When red cells are suspended in plasma or antisera, a false agglutination called
            rouleaux may be observed. This may be caused by the administration of plasma
            expanders or by protein abnormalities. Macroscopically this agglutination cannot
            be distinguished from true agglutination. Microscopically, it may appear as the
            characteristic “stack of coins” form or as large, shiny rosettes.




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                                                                                               Module	5	•	ST.008
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                        ST.009		
                        Routine Antibody Investigation


1.0 Principle
      1.1 An antibody investigation test is performed to identify unexpected antibodies
          detected in the antibody screen.
      1.2 The patient plasma is tested against a commercial reagent red cell panel using
          the PEG IAT, Saline IAT or Gel method. The reactions are compared to the reaction
          patterns of the antigens present on the panel’s red cells. These reactions are
          evaluated to identify the antibody(ies) present.

2.0 Scope and Related Policies
      2.1 An antibody investigation must be performed when unexpected results are obtained
          in the antibody screen or crossmatch. The initial panel should be performed using the
          same method as the antibody screen. The PEG IAT, Saline IAT or Gel method may be used.
      2.2 Refer all incomplete antibody investigations to CBS. At the request of the Blood
          Bank, CBS will issue donor units suitable for the patient.
      2.3 Patients with known antibodies requiring transfusion at facilities that do not
          perform antibody investigations:
          • An antibody screen must be performed on each specimen. An antibody
            investigation is not required on each specimen if the screening cells react as
            expected (the pattern of the antibody screen fits the pattern for the known
            antibody on the antigram) or are non-reactive and have had an antibody
            investigation within the last 3 months.
          • The specimen should be referred to CBS for a repeat antibody investigation at
            least every 3 months or when unexpected results in the antibody screen and/or
            crossmatch are obtained.
      2.4 In addition for patients with known clinically significant antibodies:
          • IAT crossmatch compatible antigen negative donor units must be issued.
          • If time does not permit to obtain antigen negative donor units, IAT crossmatch
            compatible donor units should be issued. Notify physician/authorized
            practitioner prior to transfusion.
      2.5 Segments from the donor units should be kept for antigen typing, send to CBS
          if applicable.
      2.6 In addition for patients with known clinically insignificant antibodies:
          • If the antibody is non-reactive, issue immediate spin crossmatch compatible
            donor units
          • If the antibody is reactive, issue IAT crossmatch compatible donor units.


Module	5	•	ST.009
Version 2 • June 2007                         Manitoba Transfusion Quality Manual for Blood Banks • 1 of 
      2.7 Commonly encountered clinically significant and insignificant antibodies:
       Significant antibodies                 D, C, c, E, e, K, k, Lub, Jka, Jkb, Fya, Fyb, S, s, Cw
       Insignificant antibodies               M, N, Lea, Leb, Lua, P1, H, I, HI

3.0 Materials
      Centrifuge or cell washer
      37°C waterbath or incubator
      Work block(s)
      Worksheet
      Test tubes
      Transfer pipettes
      Reagent red cell panel with corresponding antigram
      Plasma
      Anti-IgG
      IgG Coombs Control Cells

4.0 Procedure
      4.1 Complete an antigram with:
          • the patient’s last and first name
          • PHIN or unique identifier
          • accession number
          • date tested.
      4.2 Record the following at the bottom of all test columns used:
          • date tested
          • in-time and waterbath temperature
          • out-time and waterbath temperature
          • technologist’s initials
      4.3 Perform a panel and an autocontrol.
          • If there is a shortage of specimen an exclusion screen may be performed.
          • If the patient is known to have an antibody which will react with most cells in
            the panel, a pre-selected panel may be used which includes an antigen positive
            cell for each known antibody. When possible, this cell should have a double
            dose of the antigen.
      4.4 Grade and record the results on the antigram.
      4.5 Perform a DAT if the autocontrol is positive.
          • If the patient has a positive DAT with anti-IgG and has been transfused in the
            last 14 days, send the sample to CBS for an elution.
          • If the blood bank does not have a record of transfusion within the last 14 days,
            contact the ward/facility to confirm that the patient has not been transfused
            elsewhere.


                                                                                               Module	5	•	ST.009
2 of  • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
      4.6 Review the test results of the panel for a pattern of reactivity specific to
          an antibody(ies).
      4.7 Review the antigen profile of each non-reactive cell. When an antigen is excluded
          place an X over the antigen on the top of the column and over the positive sign
          (+) of the cell used to exclude that antigen. If the antigen is excluded by a single
          dose cell (e.g. K), use “/”.
      4.8 Antibody exclusion:
          • A double dose exclusion is required for: D, C, E, c, e, M, N, S, s, Fya, Fyb, Jka
            and Jkb.
          • Anti-C must not be excluded using a R1wR1 cell.
          • The P1, Lea and Leb antigens are excluded when one antigen positive cell is
            non-reactive; however, the expression of the antigen must NOT be weak.
          • It is not necessary to exclude low frequency antigens (eg. Cw, Kpa, Lua) UNLESS
            the antibody is suspected.
          • When excluding K, either two single dose K positive cells or one double dose
            K positive cell may be used.
          • If anti-D is detected, C and E can be excluded with two single dose cells. If not
            available crossmatch D- C- E- donor units.
          • If passive anti-D is detected, C and E can be excluded using one single dose cell.
          • If either an allo or auto anti-c is detected, exclude anti-E using two single
            dose cells. However, even when anti-E is excluded, issue E negative red cell
            components.
          • If either an allo or auto anti-e is detected, exclude anti-C using two single
            dose cells. However, even when anti-C is excluded, issue C negative red cell
            components.
      4.9 If necessary, test additional cells to complete the investigation.
          • Record each batch of tests in a separate column on the worksheet(s).
          • Ensure at least three antigen positive cells are reactive and three antigen
            negative cells are non-reactive for each antibody detected. The screening
            cells may be included.
          • If the appropriate cells are unavailable, refer the investigation to CBS.
      4.10 List the following on the antigram:
          • The probable antibody(ies) identified.
          • The antibodies that have not been excluded.
          • Additional cells that need to be tested. (e.g. additional antigen positive cells
            for the corresponding antibody)
      4.11 Phenotype the patient’s red cells for the antigens corresponding to all newly
           identified antibodies.
          • It is not necessary to complete the patient’s phenotyping before distributing IAT
            compatible antigen negative red cell components for the suspected antibody.

Module	5	•	ST.009
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 3 of 
          • A pre-transfusion specimen should be used if available.
          • If a pre-transfusion specimen is not available phenotyping results should be
            interpreted with caution.
      4.12 Phenotype red cell components for the antigens corresponding to all clinically
           significant antibodies:
          • Include all red cell components to be issued and all red cell components
            transfused within 7 days prior to the investigation.
      4.13 If the panel is non-reactive, retest the reactive screen cells or red cell components.
      4.14 Repeat all discrepant results.
          • This includes all unexpected positive or negative results obtained but does not
            include unidentified antibodies, which react with several cells.
          • When an antibody reacts with double dose cells only, non-reactive single dose
            cells are not considered discrepant. A minimum of 3 single dose cells must be
            non-reactive.
      4.15 If the specificity is not apparent, refer to CBS for investigation.

5.0 Reporting
 If the investigation is: Then report:
 Incomplete and a         • Unexpected antibodies detected in patient’s serum/
 routine request          plasma. Specimen referred out for further investigation.
                          Supplementary report to follow.
                                • If crossmatch red cell components will be issued when the
                                investigation is complete, add: Crossmatched units are not
                                available at this time. Notify Blood Bank if donor units are
                                required.
 Incomplete and a               • Unexpected antibodies detected in patient’s serum/
 STAT request                   plasma. Specimen referred out for further investigation.
                                Supplementary report to follow.
                                • Distribute IAT crossmatch compatible red cell components.
                                NOTE: If crossmatch compatible components are not obtained
                                after testing a minimum of 24 components by IAT distribute least
                                incompatible red cell components. Authorization to release crossmatch
                                incompatible donor units must be received from the BTS Medical
                                Director prior to issue.
                                • Add: An antibody was detected which reacts with all cells
                                tested. Crossmatch compatible units cannot be provided.
                                Normal red cell survival of transfused cells cannot be expected.
 Complete                       • Report: Anti- __________ detected.
                                • If an anti- D has been identified in a patient who has received Rh
                                Immune Globulin in the last 12 weeks report:
                                Passive anti-D detected probably due to the injection of RhIG
                                in ___________.
                                                                                       Module	5	•	ST.009
4 of  • Manitoba Transfusion Quality Manual for Blood Banks                       Version 2 • June 2007
6.0 Procedural Notes
       6.1 An ABO/Rh typing must be performed on all new specimens collected to be used
           in the investigation.
       6.2 Keep in mind that an antibody may react with double dose cells only.
       6.3 If test results are positive with all reagent red cells and the autocontrol is
           negative, an antibody to a high frequency antigen should be considered.
       6.4 If test results are positive with all reagent red cells and the autocontrol is positive,
           an autoantibody should be considered. If the patient has not been transfused in
           the last 3 months a warm auto-absorption will be required. Send 8 x 6 mL or 10 x
           4 mL EDTA specimens to CBS.
       6.5 If an antibody cannot be excluded, it may be helpful to phenotype the patient for
           the corresponding antigen. If the patient is antigen positive and the autocontrol
           is negative, the antibody may be excluded.



   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	        	       	       												(Senior	Management)	     	       	       		(Senior	Management)
   	        	       	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	       	       									(Date	of	implementation)




Module	5	•	ST.009
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks •  of 
                                         ST.010		
                             Direct Antiglobulin Test


1.0 Principle
      To detect in vivo red blood cell sensitization and to determine which protein
      is coating red cells.

2.0 Scope and Related Policies
      2.1 The direct antiglobulin test (DAT) may be performed for investigation of the following:
          • hemolytic disease of the newborn
          • autoimmune hemolytic anemia
          • transfusion reactions
          • sensitization caused by drugs
      2.2 A DAT is required if:
          • Antibody identification is required and an autocontrol cannot be done
            (i.e. limited volume of serum/plasma).
      2.3 The antiglobulin reagent used for all direct antiglobulin tests shall contain
          antibodies to IgG and C3d component of complement.
          The only exception is cord blood testing which may be performed with a
          monospecific anti-IgG reagent.
      2.4 Facilities that stock only anti-IgG and polyspecific AHG will perform DAT’s as follows:
          • On neonate specimens use anti-IgG reagent and saline control
          • For all other specimens use polyspecific AHG and saline control
      2.5 If a direct antiglobulin test performed on a clotted specimen identifies
          complement on the red cell surface, the result shall be verified using an
          EDTA specimen.

3.0 Materials
      EDTA anticoagulated blood:
      • Cells from a clotted specimen may be used. However, if the test is positive with
        anti-Complement, it shall be repeated on an EDTA specimen. Refer to procedural
        note 6.4.
      Serologic centrifuge
      Cell washer
      Test tubes
      Serologic pipettes
      Polyspecific AHG (anti-IgG, -Complement)
      Monspecific anti-IgG
      Monospecific anti-Complement


Module	5	•	ST.010
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 
      IgG control cells
      Complement control cells
      Buffered saline

4.0 Procedure
      4.1 Prepare a 3% suspension of the patient’s cells
      4.2 If using monospecific AHG reagents:
          • label 3 tubes with the patient’s facility chosen “unique identifier” and the
            corresponding reagent (for neonate specimen omit the C3 tube)
              Patient unique ID – IgG
              Patient unique ID – Complement
              Patient unique ID – Ctr (saline control)
          • dispense 1 drop of the patient’s 3% cell suspension into each tube
          • wash the tubes 4 times in saline
          • add 2 drops of anti-IgG to the tube labelled ‘IgG’
          • add 2 drops of anti-C3 to the tube labelled ‘Complement’
          • add 2 drops of saline to the tube labelled ‘Ctr’
          • mix and centrifuge
          • read macroscopically and microscopically
          • grade and record results
          • IgG tube (if the test is negative):
              • add 1 drop of IgG control cells
              • mix and centrifuge
              • read macroscopically
              • grade and record results
              • refer to procedural note 6.1
          • Complement tube (if the test is negative):
              • incubate 5 minutes at room temperature (refer to procedural note 6.7)
              • mix and centrifuge
              • read macroscopically and microscopically
              • grade and record results
              • if still negative, add 1 drop of Complement control cells
              • mix and centrifuge
              • read macroscopically
              • grade and record results
              • refer to procedural note 6.2




                                                                                 Module	5	•	ST.010
2 of  • Manitoba Transfusion Quality Manual for Blood Banks                 Version 2 • June 2007
      4.3 If using polyspecific AHG reagent:
          • label 2 tubes with the patient’s facility chosen “unique identifier” and the
            corresponding reagent,
          i.e. Patient unique ID – POLY (polyspecific)
              Patient unique ID – Ctr (saline control)
          • dispense 1 drop of the patient’s 3% cell suspension into each tube
          • wash the tubes 4 times in saline
          • add 2 drops of polyspecific AHG to the tube labelled ‘POLY’
          • add 2 drops of saline to the tube labelled ‘Ctr’
          • mix and centrifuge
          • read macroscopically and microscopically
          • grade and record results
          • POLY tube (if the test is negative):
              • incubate for 5 minutes at room temperature (refer to procedural note 6.7)
              • mix and centrifuge
              • read macroscopically and microscopically
              • grade and record results
              • if the tube containing the polyspecific reagent is still negative, add 1 drop
                of IgG control cells
              • mix and centrifuge
              • read macroscopically
              • grade and record results
              • refer to procedural note 6.1
          • If the result with the polyspecific AHG is positive and the control is negative,
            then the DAT must be performed with the monospecific AHG reagents
            (refer to CBS if reagents not available)




Module	5	•	ST.010
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 3 of 
5.0 Procedure
      5.1 Interpretation if using Monospecific AHG Reagents:

 Control            Anti-IgG          Anti-Complement          DAT Interpretation
 Negative           Negative          Negative                 Negative
 *Negative          Positive          Positive                 Positive – due to IgG and
                                                               Complement coating cells
 *Negative          Positive          Negative                 Positive – due to IgG coating cells
 *Negative          Negative          Positive                 Positive – due to Complement
                                                               coating cells
 Negative           Negative          TNP                      Neonate specimens only:
                                                               Negative
 Negative           Positive          TNP                      Neonate specimens only:
                                                               Positive-due to IgG coating cells
 *Positive          Positive          Positive and/or TNP      Unable to report. Refer to
                                                               procedural note 6.5. Refer to
                                                               CBS for further investigation
                                                               and reporting.


      5.2 Interpretation if using Polyspecific AHG Reagents:

 Control            Polyspecific DAT Interpretation
 Negative           Negative     Negative
 *Negative          Positive     Positive. Perform DAT using
                                 monospecific AHG reagents. If not
                                 available, then refer to CBS for
                                 further investigation and reporting.
 *Positive          Positive     Unable to report. Refer to
                                 procedural note 6.5. Refer to
                                 CBS for further investigation.
     *If the DAT is positive with polyspecific AHG, anti-IgG and/or anti-C3 and the control
      is negative, or the sample will be referred to CBS for investigation, obtain following
      history:
          • Medication
          • Transfusion history for past 3 months
          • Clinical history
      • It may be necessary to ask the recipient or recipient’s family, nurse and/or physician/
        authorized practitioner to obtain an accurate history.




                                                                                       Module	5	•	ST.010
4 of  • Manitoba Transfusion Quality Manual for Blood Banks                       Version 2 • June 2007
6.0 Procedural Notes
       6.1 The addition of IgG control cells should give a 2+ reaction. If a 2+ reaction is not
           obtained, the test is invalid and shall be repeated.
       6.2 The addition of Complement control cells should give a 1+ reaction.
           If a 1+ reaction is not obtained, the test is invalid and shall be repeated.
       6.3 Tests should be read immediately after centrifugation. Delay may cause bound
           IgG to dissociate from red cells and either leave too little IgG to detect or
           neutralize AHG reagent causing false negative results.
       6.4 False positive results due to in vitro coating with complement may be detected if
           testing is done on a clotted specimen.
       6.5 A positive control could be due to a strong cold agglutinin present in the
           recipient’s serum/plasma. In this case, wash the recipient’s cells with 37ºC saline
           and repeat the DAT.
       6.6 A mixed field reaction may indicate a transfusion reaction.
       6.7 To enhance weak anti-complement reactions, the tubes containing red cells/
           polyspecific AHG or red cells/anti-Complement are incubated for 5 minutes at
           room temperature after initial reading of the test. They are then centrifuged
           and read again.




   Facility	endorsement	if	guideline	is	used	as	a	Standard	Operating	Procedure	(SOP)

   Approved	by:	    											__________________________________	       __________________________________
   	        	       	       												(Senior	Management)	     	       	       		(Senior	Management)
   	        	       	       	        	        	        	
   Facility	effective	date:			__________________________________
   	        	       	       									(Date	of	implementation)




Module	5	•	ST.010
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks •  of 
        Forms
Forms
                                               Forms
                                         Table	of	Contents
    Inter-facility Blood, Blood Components and Derivatives
    Transfer Form .................................................................................................. FormINV.002
    Blood Bank Customer Feedback Form ....................................................... FormINV.003
    Patient Care Team Instructions – Handling Blood,
    Blood Components and Derivatives Shipped with a Patient .................. FormINV.004
    Receipt of Reagent Record............................................................................. FormQC.001
    Quality Control of Reagents: Quality Control Record.............................. FormQC.002
    Daily Temperature Record: Refrigerator ..................................................... FormQC.003
    Daily Temperature Record: Freezer ............................................................. FormQC.004
    Daily Temperature Record: Platelet Incubator .......................................... FormQC.005
    Daily Temperature Record: Incubator (Waterbath) ................................... FormQC.006a
    Daily Temperature Record: Incubator (Heating Block) ............................ FormQC.006b
    Daily Temperature Record: Incubator (Plasma Thawer) .......................... FormQC.006c
    Alarm System Check Record: Refrigerator ................................................ FormQC.007
    Alarm System Check Record: Freezer ........................................................ FormQC.008
    Equipment Malfunction and Corrective Action Record........................... FormQC.009
    Calibration Record: Incubator ...................................................................... FormQC.010
    Calibration Record: Serologic Centrifuge ................................................... FormQC.011
    Verification of Non Reference Thermometers Worksheet ...................... FormQC.012
    Daily Cell Washer Maintenance Record ...................................................... FormQC.013
    Weekly Cell Washer Maintenance Record .................................................. FormQC.014
    Daily Cleaning Checklist ............................................................................... FormQC.015
    Weekly Cleaning Record ................................................................................ FormQC.016
    Monthly Cleaning Record .............................................................................. FormQC.017
    Platelet Incubator ............................................................................................ FormQC.018
    Plasma Thawing Form .................................................................................... FormQC.019
    Blood Component Order Form (CBS) .......................................................... F040547
    Plasma Proteins Order Form (CBS) ............................................................. 1000103464
Forms	•	Table	of	Contents
Version 2 • June 2007                                        Manitoba Transfusion Quality Manual for Blood Banks
Inter-facility	Blood,	Blood	Components	and	Derivatives	Transfer	Form
FormINV.002                                                                                                Version 2.0
Section A: To be Completed by Issuing Facility:
 From:                                                      Phone Number: (204)                          Ambient Temp:
                                                                                                         ≤ 15oC
 (Facility)                                                 Fax Number: (204)                            > 15oC
 To:                                                                                Transportation Mode:
                                                                                    Ambulance Lab Truck Bus
 (Facility)                                                                         Driver Taxi Life Flight Other: ________

 Packaged By:                                     Date                              Time               Security Sealed?
 Name:                                                                                                 Yes     No
 (Print)                                                 DD/MMM/YYY
Patient Information:
 Last Name                                               First Name                               PHIN

 Date of Birth                                           Chart/Medical Record Number
                    DD/MMM/YYYY
Blood, Blood Components:
 Component        Centre   Check    Unit Number      ABO/Rh       Expiration                Disposition Information
                   Code    Digit                                    Date             Date/Time        Discarded     Returned
                                                                                     Transfused          Date         Date




Derivatives:
       Product                  Lot Number                 Expiration Date               Disposition Information
                                                                                 Date/Time        Discarded      Returned
                                                                                 Transfused         Date           Date




Note: All blood components and derivatives have been visually inspected and found suitable at time of issue.
Note: All red cell units must be transfused prior to midnight on: DD______MMM_______YYYY_________
Section B: To be Completed by Receiving Facility:
 Facility                               Received By: Name (Print)            Date                         Time     Travel
                                                                                                                   Time:

 Packaging:                             Security Seal Intact?                All products listed above accounted for
 Acceptable      Unacceptable           Yes        No                        (received and/or transfused)? Yes No
 For red cell units please document method of storage:
 Controlled Blood Bank Refrigerator     Other___________________________________
Note: Contact the shipping facility immediately if travel time exceeds 24 hours, if packaging is unacceptable or products
are unaccounted for.

Forms
Version 2 • June 2007                                      Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
                         Blood	Bank	Customer	Feedback	Form
FormINV.003                                                                                   Version 2.0
 CUSTOMER CONTACT INFORMATION                                                     FOR CBS USE
 Name:                                                           Date Received:

 Position:                                                       Received By:


 Facility:                                                       QIR Prepared:  Yes No
                                                                 Log No.___________________


Please provide as much information as possible, including unit/lot numbers and supporting documents.

 Date Discovered:                                   Date Occurred (if different):
 CBS Department Involved in Occurrence:            BPM    Crossmatch Lab

 Discussed with __________________________ at CBS on ___________________ (if applicable)

 Blood, Blood Component or Derivative Type:
 q RBC             q Platelets     q FFP                 q Cryosupernatant Plasma
 q Cryoprecipitate q Derivative q Other:
 Category: Product Quality                 Product Delivery                Service Delivery

 Type:
 q Hemolyzed                         q Packing Slip Incorrect            q Communication Problem
 q Lipemic/Icteric                   q Product Tag Incorrect             q Delivery Delay
 q Damaged/Broken Pack               q Patient Report Incorrect

 q DAT Positive                      q Incorrect Packaging
 q Illegible Date                    q No Security Seal

 q Incomplete Order Received

 q Incorrect Order Received

 Description:




                                                                                                         Forms
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                            Version 2 • June 2007
 FormINV.004                                                                                  Version 2.0
                           Patient Care Team Instructions
     Handling Blood, Blood Components and Derivatives Shipped with a Patient

1. The shipping container(s) in which the blood, blood components and derivatives are
   packed, may be used to maintain storage conditions for a 24-hour period if the container
   remains closed.

2. The container is sealed with a security seal to ensure the blood, blood components and
   derivatives are secure until needed for transfusion. Cut the seal using heavy-duty scissors.

3. Do not open the shipping container until a blood, blood component or derivative
   is needed for transfusion.

4. Remove only what is needed for transfusion. Do not disturb the packing configuration
   of the remaining units, the ice/gel packs or the cardboard inserts.

5. Immediately re-close the box. Ensure that the Styrofoam lid is in place, close flaps
   and secure strap.

6. Failure to keep the box closed will adversely affect the interior temperature and
   jeopardize the safety of the contents.

7. Inside the box you will find an “Inter-facility Blood, Blood Components and Derivatives
   Transfer Form”. Complete the disposition information (Date/Time Transfused) adjacent
   to each unit number as each unit is transfused.

8. Immediately upon arrival at your destination, send all shipping containers with all
   unused blood, blood components and derivatives and the completed Inter-facility
   Blood, Blood Components and Derivatives Transfer Form to the Blood Bank.

9. Should you have any questions call                                    at (204)
                                        insert your facility name here              insert your lab number here.


   Patient Name: ____________________________________________________________________

   PHIN: ____________________________________________________________________________

   Type of Blood Product: ____________________________________________________________

   Number of Units: _________________________________________________________________

   Packed By: _______________________________________________________________________

   Date: ___________________________________________________________________________

   Time: ____________________________________________________________________________

 Forms
 Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 3 of 2
                                                                                                                                                                                                   FormQC.001
                                                                Receipt of Reagent Record
                                                                Reagent Specificity: ____________________________
                                                                Supplier:_____________________________________                                     Insert Revision Number/Date:_________________
                                                                Lot Number Expiry Date     Date      Received/ Package     Visual     Receipt of     Tested By Controls                Pos Control   Neg Control
                                                                                           Received/ Inspected Intact-     Inspection Certificate of           Results of  Results of  ID of Reagent ID of Reagent
                                                                                           Inspected by        Y/N         OK -Y/N    Authenticity             Pos Control Neg Control Used/Lot #    Used/Lot #
                                                                                                                                      Y/N




4 of 2 • Manitoba Transfusion Quality Manual for Blood Banks
                                                                Supervisory Review By:______________________________________                                                                       Version 2.0
                                                                Date:________________________




                Forms
Version 2 • June 2007
                             Quality	Control	of	Reagents
FormQC.002 (1 of 2)
Version 2.0

                                    Quality Control Record                   Week :______________________
 Reagent           Manufacturer/    Expiration     Reagent Appearance
 Specificity       Lot Number       Date
                                                   Date    Date    Date     Date     Date    Date     Date
 A1 cells
 B cells
 Anti-A
 Anti-B
 Anti-A,B
 Anti-D1
 Anti-D2
 Rh Control

 Screen cell I

 Screen cell II
 Screen cell III

 Anti-IgG

 Anti-C3b-C3d

 IgG Control
 Cells
 C3 Control
 Cells
 PEG

 Saline

 QC Kit
 Antibody
 QC Kit Cell 1

 QC Kit Cell 2

 MTS Anti-IgG
 Gel Cards
 Quality Control Testing done by:

 Results reviewed by (signature/date) :

S= Satisfactory; N= Not Satisfactory; NU= Not in Use
Forms
Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks •  of 2
                                      Quality	Control	of	Reagents
    FormQC.002 (2 of 2)
    Version 2.0
                      Quality Control Record: Ortho Confidence System
           Reagent                  Test           Expected                         QC Test Results
          Specificity            Procedure          Results
                                                                   Day 1   Day 2   Day 3   Day 4   Day 5   Day 6   Day 7
Anti-A        Cell 1 (A1B rr)   IS             1-4+
              Cell 2 (O R1r)    IS             0
Anti-B        Cell 1 (A1B rr)   IS             1-4+
              Cell 2 (O R1r)    IS             0
Anti-A,B      Cell 1 (A1B rr)   IS             1-4+
              Cell 2 (O R1r)    IS             0
Anti-D1       Cell 1 (A1B rr)   IS             0
              Cell 2 (O R1r)    IS             1-4+
Anti-D2       Cell 1 (A1B rr)   IS             0
              Cell 2 (O R1r)    IS             1-4+
Rh            Cell 1 (A1B rr)   IS             0
Control       Cell 2 (O R1r)    IS             0
A1 cells      QC antibody       IS             1-4+

B cells       QC antibody       IS             1-4+

SC I          QC antibody       IAT            1-3+ if
                                               antigen
                                               present
SC II         QC antibody       IAT            1-3+ if
                                               antigen
                                               present
SC III        QC antibody       IAT            1-3+ if
                                               antigen
                                               present
Anti-IgG      IgG CC            IS             3-4+
Anti-         C3 CC             IS             1-4+
C3b-C3d
IgG CC        0.9% Saline       IS             0

C3 CC         0.9% Saline       IS

Quality Control Testing done by:
Results reviewed by (signature/date) :

IS=Immediate Spin; IAT= Indirect Antiglobulin Test; IgG CC=IgG Control Cells; C3 CC=C3 Control Cells
                                                                                                               Forms
    of 2 • Manitoba Transfusion Quality Manual for Blood Banks                               Version 2 • June 2007
                                                                Daily Temperature Record: Refrigerator #_______________                                         FormQC.003




Forms
                                                                                Month/Year:___________________

                                                                                   Thermo-               Read           Thermo-           Read             Thermo-           Read
                                                                 Day     Time       meter      Temp              Time    meter     Temp            Time     meter     Temp
                                                                                                          by:                              by:                                by:
                                                                                   location                             location                           location
                                                                   1




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Manitoba Transfusion Quality Manual for Blood Banks •  of 2
                                                                Reviewed by (signature/date): _______________________________________________________________
                                                                Daily Temperature Record: Freezer #________________________                                     FormQC.004
                                                                                Month/Year:___________________

                                                                                   Thermo-               Read           Thermo-           Read             Thermo-           Read
                                                                 Day     Time       meter      Temp              Time    meter     Temp            Time     meter     Temp
                                                                                                          by:                              by:                                by:
                                                                                   location                             location                           location
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                Forms
Version 2 • June 2007
                                                                                                                                                                       Version 2.0
                                                                Reviewed by (signature/date): _______________________________________________________________
                                                                Daily Temperature Record: Platelet Incubator #_________________                                 FormQC.005




Forms
                                                                                Month/Year:___________________

                                                                                   Thermo-               Read           Thermo-           Read             Thermo-           Read
                                                                 Day     Time       meter      Temp              Time    meter     Temp            Time     meter     Temp
                                                                                                          by:                              by:                                by:
                                                                                   location                             location                           location
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Manitoba Transfusion Quality Manual for Blood Banks •  of 2
                                                                Reviewed by (signature/date): _______________________________________________________________
                                                                 Daily Temperature Record: Incubator #_______________________                                    FormQC.006a
                                                                                                                                                                 (Waterbath)
                                                                                 Month/Year:___________________

                                                                                    Thermo-               Read           Thermo-           Read             Thermo-           Read
                                                                  Day     Time       meter      Temp              Time    meter     Temp            Time     meter     Temp
                                                                                                           by:                              by:                                by:
                                                                                    location                             location                           location
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                Forms
Version 2 • June 2007
                                                                                                                                                                        Version 2.0
                                                                 Reviewed by (signature/date): _______________________________________________________________
                                                                 Daily Temperature Record: Incubator #_________________                                          FormQC.006b




Forms
                                                                                                                                                                 (Heating Block)
                                                                                 Month/Year:___________________

                                                                                    Thermo-               Read           Thermo-           Read             Thermo-           Read
                                                                  Day     Time       meter      Temp              Time    meter     Temp            Time     meter     Temp
                                                                                                           by:                              by:                                by:
                                                                                    location                             location                           location
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Version 2 • June 2007
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Manitoba Transfusion Quality Manual for Blood Banks • 11 of 2
                                                                 Reviewed by (signature/date): _______________________________________________________________
                                                                 Daily Temperature Record: Incubator #_______________________                                    FormQC.006c
                                                                                                                                                                 (Plasma Thawer)
                                                                                 Month/Year:___________________

                                                                                    Thermo-               Read           Thermo-           Read             Thermo-           Read
                                                                  Day     Time       meter      Temp              Time    meter     Temp            Time     meter     Temp
                                                                                                           by:                              by:                                by:
                                                                                    location                             location                           location
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                Forms
Version 2 • June 2007
                                                                                                                                                                        Version 2.0
                                                                 Reviewed by (signature/date): _______________________________________________________________
                           Alarm System Check Record:                                     FormQC.007
                                  Refrigerator

         Serial #:                                   Manufacturer:

         Date tested:                                Tested by:

                                         Result                     Comment / Action Taken
         Audible alarm test
         Back-up power supply
         Low temperature                    Temp          Temp
                                          Alarm on      Alarm Off
                                                                      Intended alarm activation: 1°C
         sensor activation
         High temperature                   Temp          Temp
                                          Alarm on      Alarm Off
                                                                      Intended alarm activation: 6°C
         sensor activation

         Other (specify)


         Comments / Corrective action:




         “Pass”         N = No
         “Fail”         Y = Yes


          Reviewed by (signature/date):__________________________


                                                                                       Version 2.0




Forms
Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks • 13 of 2
                             Alarm System Check Record:
                                       Freezer
                                                                                           FormQC.008
         Serial #:
                                                            Manufacturer:
         Date tested:                                       Tested by:

                                              Result                      Comment / Action Taken
         Audible Alarm test

         Back-up power supply

                                                 Temp           Temp
         High temperature                      Alarm on       Alarm Off     Intended alarm activation:
         sensor activation                                                   -180 C


         Other (specify)

         Comments / Corrective action:




         Pass                                             N = No
         Fail                                             Y = Yes

          Reviewed by (signature/date): ____________________________


                                                                                             Version 2.0




                                                                                                              Forms
14 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                                Version 2 • June 2007
                            Equipment Malfunction
                                             and
                           Corrective Action Record                                FormQC.009
Equipment: ____________________           Model #: ___________
Serial #: ________________________

Location: ______________________

Date: __________________ Time: _________
Reported by: __________________________

If this is a satellite refrigerator did the nursing unit call you?         q Yes     q No

State Problem:
q Refrigerator alarm triggered. Temperature at time of alarm ________oC
q Freezer alarm triggered. Temperature at time of alarm _________oC
q Platelet Incubator alarm triggered. Temperature at time of alarm _____ oC
q Plasma Thawer outside of 30 to 37 o C range. Temperature when discovered ________ oC
q Room alarm triggered. Temperature at time of alarm __________ oC
q Other:


Cause of alarm:     q Door ajar q Malfunction
Describe action(s) taken. Include temperatures taken at 10 or 15 minute intervals.




Supervisory Review:
Was the service company or maintenance called?            q Yes           q No
Was the problem resolved?                                 q Yes           q No
Corrective action taken:



Reviewed by (signature/date): ___________________________________________________
                                                                                   Version 2.0



Forms
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
                              Calibration: Incubator                     FormQC.010

                            Calibration Record: Incubator

    Date        Time        Temp       Read by:       Date       Time   Temp   Read by:




Reviewed by (signature/date): _____________________________
                                                                          Version 2.0


                                                                                                 Forms
1 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                   Version 2 • June 2007
                                             Calibration:
                                         Serologic Centrifuge                                  FormQC.011

                         Calibration Record: Serologic Centrifuge

 Serial #:                                             Manufacturer:


 Received      q        Service      q    Bi-Annual    q

                                         Date           Timer         Stop Watch          Tested by
                                                           Sec
                                                           Sec
 Timer Check
                                                           Sec
                                                           Sec
                                                           Sec

                                         Date                    RPM                      Tested by
 RPM Check



                                         Date                     RCF                  Calculated by
 RCF Check



 Acceptable                       Unacceptable



 Comments:




                                                                                         Version 2.0
Reviewed by (signature/date): _______________________________




Forms
Version 2 • June 2007                                 Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
Verification of Non Reference Thermometers Worksheet
Date Purchased ___________________ Manufacturer _________________
Serial Number: _______________

Thermometer Type: Glass q                Digital q
                                                                                               FormQC.012
                                                      Reference        Test
 Date       Visual   Battery Changed      Medium      Thermometer      Thermometer     Pass/Fail    Comments
                                                      Reading          Reading




 Key:                     Visual:         Satisfactory (S) Not Satisfactory (NS)
                          Medium:         Air (A)           10% Glycerol (10% G)     Distilled Water (DW)
                          Pass/Fail:      Pass (P) Fail (F)

Reviewed by (signature/date): ______________________________                               Version 1.0



                                                                                                      Forms
18 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                        Version 2 • June 2007
Daily Cell Washer Maintenance Record
Laboratory: _________________________                Name: ____________________
Asset #: ___________________________                 Serial #: ___________________
Month/Year: _______________________                                                        FormQC.013
          Inspect      Volume       Pass    Fail   Adjusted Volume         Levels         Clean      Soak
  Date
          Tubing      Delivered                     #1     #2     #3     Checked by:                 Head
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Reviewed by (signature/date):_______________________________________________                    Version 2.0
Forms
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
Weekly Cell Washer Maintenance Record
Year: ___________
Laboratory: ________________________                      Name: ______________________
Asset #: ____________________________                     Serial #: _____________________
                                                                                             FormQC.014
                                            Supervisory                                            Supervisory
          Decontamination    Cleaned by:/                         Decontamination   Cleaned by:/
 Week                                       Review By:/    Week                                    Review by:/
              by:/Date           Date                                 by:/Date          Date
                                               Date                                                   Date
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Reviewed by (signature and date): _____________________________                               Version 2.0




                                                                                                          Forms
20 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                            Version 2 • June 2007
Daily Cleaning Checklist
NOTE: Please initial as performed.   Month/Year: ___________/__________
                                                                                 FormQC.015
               Counters          Immufuges            Sinks          Suctions         Pipettors
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                                                                                   Version 2.0
Reviewed by (signature/date): ______________________________________



Forms
Version 2 • June 2007                    Manitoba Transfusion Quality Manual for Blood Banks • 21 of 2
                                  Weekly Cleaning Record
Laboratory: _________________ Equipment Name: __________________ Year: _______
Asset#: _____________________ Serial #: ____________________________
                                                                                    FormQC.016
 Week     Cleaned by:/      Supervisory review        Week       Cleaned by:/   Supervisory review
          Date              by:/Date                             Date           by:/Date

    1                                                   27

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                                                                                      Version 2.0
Comments: ______________________________________________________




                                                                                                         Forms
22 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                           Version 2 • June 2007
                               Monthly Cleaning Record

Laboratory: __________________________    Equipment Name: ____________________
Year: _______ Asset#: _________________   Serial #: _____________________________
                                                                                         FormQC.017
 Month      Cleaned by        Date        Supervisory review by:      Date          Comments:

     1

     2

     3

     4

     5

     6

     7

     8

     9

    10

    11

    12


Additional Comments: ____________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
                                                                                           Version 2.0




Forms
Version 2 • June 2007                           Manitoba Transfusion Quality Manual for Blood Banks • 23 of 2
                              Alarm System Check Record:
                                   Platelet Incubator
                                                                                        FormQC.018
 Serial #:                                        Manufacturer:

 Calibrated thermometer serial #:
 Date tested:                                     Tested by:
                                       Result                     Comment / Action Taken

 Audible alarm test

 Battery Back-up test
                                      Intended alarm activation: 20.5°C
 Low temperature                      Internal thermometer temperature:
 sensor activation                    Calibrated thermometer temperature:
                                      Intended alarm activation: 23.5°C
 High temperature                     Internal thermometer temperature:
 sensor activation                    Calibrated thermometer temperature:


 Other (specify)
 Comments / Corrective action:




 Pass
 Fail
                                                                                          Version 1.0
Reviewed by:__________________________                           Date: _____________




                                                                                                       Forms
24 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                         Version 2 • June 2007
                        Thawing Frozen Blood Products                                     FormQC.019
                         Temperature Recording Chart

Date: ______________________________________________

Product Information:          FFP              Cryo.

Product Code: ______________________________________

Initial Blood Product Inspection after                 OK                     Pkg. Cracked/
removal from packaging:                                Continue               Broke Retrieve




             Initial water Temperature Reading: _________________
              Direction:             Intervals            Temperature
                                     5 Min.
                                     10 Min.
              Knead Product          15 Min.
                                     20 Min.
                                     25 Min.
                                     30 Min.

                                    Dry bag and Ports



Visual Inspection:                    OK                      X

Name and Initials:_____________________________________


Note: Remember to document product issue in the Issue/Transfusion Record
(lab log)


Comments:_____________________________________________________________________
_______________________________________________________________________________
_________________________________________________________________________________________________
________________________________________________________________________________________________
________________________________________________________________________________________________
                                                                                      Version 1.0




Forms
Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks • 2 of 2
                                                                                 Forms
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks   Version 2 • June 2007
Forms
Version 2 • June 2007   Manitoba Transfusion Quality Manual for Blood Banks • 2 of 2
Appendices




             Appendices
                                  Appendix	1:
      Abbreviations                                                           Version 1.0
        Abbreviation.                               Term
       2,3-DPG          2,3-diphosphoglycerate
       AABB             American Association of Blood Banks
       AHF              Anti-Hemaphilic Factor
       AHG              Anti-Human Globulin
       AHTR             Acute Hemolytic Transfusion Reaction (also HTR)
       AIDS             Acquired Immune Deficiency Syndrome
       ANH              Acute Normovolemic Hemodilution
       aPPT             Activated Partial Thromboplastin Time
       ARDS             Acute Respiratory Distress Syndrome
       BPM              Blood Product Management (CBS)
       CBS              Canadian Blood Services
       CHD              Coronary Heart Disease
       CMV              Cytomegalovirus
       CPD              Citrate, Phosphate, Dextrose (solution)
       CPDA-1           Citrate, Phosphate, Dextrose-Adenine (solution)
       C/T              Crossmatch-to-Transfusion ratio (C:T)
       CV               Coefficient of Variation
       DAT              Direct Antiglobulin Test also known as Coombs Test
       DIC              Disseminated Intravascular Coagulopathy
       D5W              Dextrose 5% water
       EACA             Epsilon-Aminocaproic Acid
       FDA              Food and Drug Administration
       FFP              Fresh Frozen Plasma
       FNHTR            Febrile Non-Hemolytic Transfusion Reaction
       GGTP             Gamma Glutamyl Transferase (GGT)
       GVHD             Graft-Versus-Host Disease
       HBsAg            Hepatitis B Surface Antigen
       HB               Hemoglobin
       HCT              Hematocrit
       HBV              Hepatitis B Virus
       HCV              Hepatitis C Virus
       HDN              Hemolytic Disease of the Newborn
       HIV              Human Immunodeficiency Virus
       HLA              Human Leukocyte Antigen
       HTLV-I/II        Human T-cell Lymphotropic Virus type I/II
       HTR              Hemolytic Transfusion Reaction


Appendix	1
Version 2 • June 2007                    Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
                                             Appendix	1:
       Abbreviations                                                         Version 1.0
         Abbreviation.                                       Term
        IAD                    Intraoperative Autologous Donation
        IAT                    Indirect Anti-globulin Test
        IgA                    Immunoglobulin A
        IU                     International Units
        MCH                    Mean Corpuscular Hemoglobin
        MCHC                   Mean Corpuscular Hemoglobin Concentrate
        MCV                    Mean Corpuscular Volume
        mg/dL                  milligrams per deciliter
        NAT                    Nucleic Acid Amplification Testing
        NS                     Normal Saline
        OR                     Operating Room
        PABD                   Pre-operative Autologous Blood Donation
        PAC                    Pre-Admission Clinic
        PAT                    Preoperative Autologous Blood Transfusion
        PEG                    Polyethylene glycol
        PFC                    Perflurochemical(s)
        PLTs                   Platelets
        PRP                    Platelet-Rich Plasma
        PTT                    Partial Thromboplastin Time
        Q-T                    from QRS complex to end of T wave (interval)
        RBCs                   Red Blood Cells
        RCF                    Relative Centrifugal Force
        Rh                     Rhesus Factor
        RPM                    Revolutions Per Minute
        RT                     Registered Technologist; Room Temperature
        STS                    Serological Test for Syphilis
        T&S                    Type and Screen
        TA-GVHD                Transfusion-Associated Graft-Versus-Host Disease
        TRALI                  Transfusion-Related Acute Lung Injury
        TTP                    Thrombotic Thrombocytopenic Purpura
        vCJD                   Variant Creutzfeldt-Jakob Disease
        WBCs                   White Blood Cells




                                                                                         Appendix	1
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                  Version 2 • June 2007
                                              Appendix	2:
Facility Contact List                                                                        Version 2.0
  Location         Facility                   Address                      Telephone          Fax Number
                   Altona Community           Box 660,                     204-324-6411
  Altona                                                                                      204-324-1299
                   Health Centre              Altona, MB R0G 0B0           Ext. 221
                   Arborg & District          Box 10, 234 Gislason Drive
  Arborg                                                                   204-376-5247       204-376-5669
                   Health Centre              Arborg, MB R0C 0A0
                   Lakeshore Health           Box 110
  Ashern                                                                   204-768-2461       204-768-2337
                   Centre - Ashern            Ashern, MB R0C 0E0
                                              125 Elizabeth Street East
  Baldur           Baldur Health Centre                                    204-535-2373       204-535-2116
                                              Baldur, MB R0K 0B0
                   Beausejour                 Box 1178 Beausejour,
  Beausejour                                                               204-268-1076       204-268-1207
                   Health Centre              MB R0E 0C0
                                              Box 2000
  Birtle           Birtle Health Centre                                    204-842-3317       204-842-3375
                                              Birtle, MB R0M 0C0
                   Boissevain                 Box 899
  Boissevain                                                               204-534-2451       204-534-6487
                   Health Centre              Boissevain, MB R0K 0E0
                                              Unit 1 - 150 McTavish
                   Westman Regional
  Brandon                                     Avenue East                  204-578-4473       204-578-4869
                   Laboratory - Brandon
                                              Brandon, MB R7A 7H8
                   Carberry Plains District   Box 2000
  Carberry                                                                 204-834-3198       204-834-3333
                   Health Centre              Carberry, MB R0K 0H0
                   Carman                     Box 610
  Carman                                                                   204-745-2021       204-745-2756
                   Memorial Hospital          Carman, MB R0G 0J0
                   Churchill                  General Delivery             204-675-8315
  Churchill                                                                                   204-675-2481
                   Regional Hospital          Churchill, MB R0B 0E0        Ext. 315
                   Rock Lake Health           Box 130
  Crystal City                                                             204-873-2132       204-873-2185
                   District - Crystal City    Crystal City, MB R0K 0N0
                   Dauphin                    625 - 3rd Street S.W.
  Dauphin                                                                  204-638-3840       204-638-2189
                   General Hospital           Dauphin, MB R7N 1R7
                   Deloraine                  Box 447
  Deloraine                                                                204-747-2745       204-747-2160
                   Health Centre              Deloraine, MB R0M 0M0
                   E. M. Crowe Memorial       Box 130
  Eriksdale                                                                204-739-2611       204-739-2065
                   Hospital - Eriksdale       Eriksdale, MB R0C 0W0
                   Emerson                    Box 428
  Emerson                                                                  204-373-2109       204-373-2748
                   General Hospital           Emerson, MB R0A 0L0
                   Erickson District          Box 25
  Erickson                                                                 204-636-7777       204-636-2471
                   Health Centre              Erickson, MB R0J 0P0
                   Flin Flon                  Box 340
  Flin Flon                                                                204-687-9644       204-687-9606
                   General Hospital           Flin Flon, MB R8A 1N2
                   Johnson Memorial           117 - 7th Avenue
  Gimli                                                                    204-642-6056       204-642-5860
                   Hospital - Gimli           Gimli, MB R0C 1B0




Appendix	2
Version 2 • June 2007                                Manitoba Transfusion Quality Manual for Blood Banks • 1 of 
                                             Appendix	2:
Facility Contact List                                                                    Version 2.0
  Location         Facility                   Address                   Telephone         Fax Number
                                              Box 2000                  204-652-2600
  Gillam           Gillam Hospital                                                        204-652-2536
                                              Gillam, MB R0B 0L0        Ext. 108
                                              Box 1000
                   Seven Regions Health
  Gladstone                                   24 Mill Street            204-385-2968      204-385-2173
                   Centre - Gladstone
                                              Gladstone, MB R0J 0T0
                                              Box 310
  Glenboro         Glenboro Hospital                                    204-827-2438      204-827-2199
                                              Glenboro, MB R0K 0X0
                                              Box 339
  Grandview        Grandview Hospital                                   204-546-2721      204-546-3269
                                              Grandview, MB R0L 0Y0
                   Hamiota District           177 Birch Avenue          204-764-2412
  Hamiota                                                                                 204-764-2049
                   Health Centre              Hamiota, MB R0M 0T0       Ext. 212
                   Percy E. Moore             Box 190
  Hodgson                                                               204-372-8444      204-372-6991
                   Hospital - Hodgson         Hodgson, MB R0C 1N0
                   Tri-Lake Health Centre     86 Ellis Drive            204-523-4661
  Killarney                                                                               204-523-8948
                   - Killarney                Killarney, MB R0K 1G0     Ext. 214
                                              Box 370
                   Leaf Rapids
  Leaf Rapids                                 Town Centre               204-473-2441      204-473-2524
                   Health Centre
                                              Leaf Rapids, MB R0B 1W0
                                              Box 2030
  Lynn Lake        Lynn Lake Hospital                                   204-356-2474      204-356-8023
                                              Lynn Lake, MB R0B 0W0
                   MacGregor                  Box 250
  MacGregor                                                             204-685-2850      204-685-2529
                   Health Centre              MacGregor, MH R0H 0R0
                   McCreary/Alonsa            Box 250
  McCreary                                                              204-835-2476      204-835-2713
                   Health Centre              McCreary, MB R0J 1B0
                   Melita & Area Health       Box 459
  Melita                                                                204-522-8197      204-522-3161
                   Centre                     Melita, MB R0M 1L0
                   Minnedosa Health           Box 960
  Minnedosa                                                             204-867-2701      204-867-2239
                   Centre                     Minnedosa, MB R0J 1E0
                                              Box 519
  Morris           Morris General Hospital                              204-746-2316      204-746-2445
                                              Morris, MB R0G 1K0
                   Neepawa District           Box 1240
  Neepawa                                                               204-476-2394      204-476-5007
                   Memorial Hospital          Neepawa, MB R0J 1H0
                                              P.O.Box 730
  Norway
                   Norway House Hospital      Norway House, MB          204-359-6731      204-359-6014
  House
                                              R0B 1B0
                                              Box 130
  Notre Dame
                   Notre Dame Hospital        Notre Dame de             204-248-2092      204-248-2768
  de Lourdes
                                              Lourdes, MB R0G 1M0
                                              Box 220
  Pinawa           Pinawa Hospital                                      204-753-2334      204-753-8446
                                              Pinawa, MB R0E 1L0



                                                                                                  Appendix	2
2 of  • Manitoba Transfusion Quality Manual for Blood Banks                           Version 2 • June 2007
                                                Appendix	2:
 Facility Contact List                                                                           Version 2.0
  Location           Facility                    Address                      Telephone           Fax Number
                     Pine Falls Health           Box 2000                     204-367-4441
  Pine Falls                                                                                      204-367-8981
                     Complex                     Pine Falls, MB R0E 1M0       Ext. 117
                                                 524 Fifth Street
  Portage la         Portage District            South East
                                                                              204-239-2211        204-239-6039
  Prairie            General Hospital            Portage la Prairie,
                                                 MB R1N 3A8
                     Reston District             Box 250
  Reston                                                                      204-877-3925        204-877-3998
                     Health Centre               Reston, MB R0M 1X0
                     Riverdale Health            Box 428
  Rivers                                                                      204-328-7656        204-328-7130
                     Centre - Rivers             Rivers, MB R0K 1X0
                     Roblin District             Box 940
  Roblin                                                                      204-937-2142        204-937-8892
                     Health Centre               Roblin, MB R0L 1P0
                     Rossburn District           Box 40
  Rossburn                                                                    204-859-2413        204-859-2526
                     Health Centre               Rossburn, MB R0J 1V0
                     Russell District            Bag Service #2
  Russell                                                                     204-773-2125        204-773-2142
                     Health Centre               Russell, MB R0J 1W0
                     Selkirk & District          Box 5000
  Selkirk                                                                     204-482-5800        204-785-2212
                     General Hospital            Selkirk, MB R1A 2M2
                     Shoal Lake - Strathclair    Box 490
  Shoal Lake                                                                  204-759-2336        204-759-2230
                     Health Centre               Shoal Lake, MB R0J 1Z0
                     Snow Lake Medical           Box 453
  Snow Lake                                                                   204-358-2300        204-358-7310
                     Nursing Unit                Snow Lake, MB R0B 1M0
                                                 Box 10
  Souris             Souris District Hospital                                 204-483-2721        204-483-3719
                                                 Souris, MB R0K 2C0
                                                 Box 400
  St. Claude         St. Claude Hospital                                      204-379-2585        204-379-2655
                                                 St. Claude, MB R0G 1Z0
                                                 Box 320,
                     Desalaberry Dist Health     354 Prefontaine St.          204-443-7611
  St. Pierre Jolys                                                                                204-433-7455
                     Centre – St. Pierre         St. Pierre Jolys, MB         Ext. 252
                                                 R0A 1V0
                                                 52 St. Gerard Street
  Ste. Anne          Ste. Anne Hospital                                       204-442-8837        204-442-9929
                                                 Ste. Anne, MB R5H 1C4
                                                 Box 292
  Ste. Rose          Ste. Rose General
                                                 Ste. Rose du Lac, MB         204-447-2227        204-447-2834
  du Lac             Hospital
                                                 R0L 1S0
                     Bethesda Hospital -         Box 939                      204-346-0754
  Steinbach                                                                                       204-346-1381
                     Steinbach                   Steinbach, MB R0A 2A0        Ext.203
                     Stonewall & District        601 - 3rd Avenue South
  Stonewall                                                                   204-467-5514        204-467-4431
                     Health Centre               Stonewall, MB R0C 2Z0
                     Lorne Memorial              Box 40
  Swan Lake                                                                   204-836-2132        204-836-2044
                     Hospital – Swan Lake        Swan Lake, MB R0G 2S0


Appendix	2
Version 2 • June 2007                                   Manitoba Transfusion Quality Manual for Blood Banks • 3 of 
                                              Appendix	2:
Facility Contact List                                                                    Version 2.0
 Location          Facility                   Address                    Telephone         Fax Number
                   Swan River                 Box 1348
 Swan River                                                              204-734-2064      204-734-5714
                   Valley Hospital            Swan River, MB R0L 1Z0

                                              Box 1440
 Teulon            Teulon Hospital                                       204-886-2433      204-886-2653
                                              Teulon, MB R0C 3B0
                   The Pas Health             Box 240
 The Pas                                                                 204-623-9206      204-623-3115
                   Complex                    The Pas, MB R9A 1K4
                   Thompson                   871 Thompson Drive
 Thompson                                                                204-667-5304      204-667-5317
                   General Hospital           Thompson, MB R8N 0C8
                   Tiger Hills Health         Box 130
 Treherne                                                                204-723-2133      204-723-2869
                   District - Treherne        Treherne, MB R0G 2V0
                                              Box 400,
 Virden            Virden District Hospital                              204-748-1420      204-748-2053
                                              Virden, MB R0M 2C0
                   Vita & District            217 First Avenue
 Vita                                                                    204-425-3804      204-425-3545
                   Health Centre              Vita, MB R0A 2K0
                                              Box 309,
                   Wawanesa
 Wawanesa                                     506 George St.             204-824-2335      204-824-2148
                   Health Centre
                                              Wawanesa, MB R0K 2G0
                                              Box 2000,
                   Boundary Trails Health
 Winkler                                      Station Main               204-331-8800      204-331-8930
                   Centre - Winkler
                                              Winkler, MB R6W 1H8
                   Concordia General          1095 Concordia Avenue
 Winnipeg                                                                204-661-7174      204-661-7206
                   Hospital                   Winnipeg, MB R2K 3S8
                                              2109 Portage Avenue
 Winnipeg          Deer Lodge Centre                                     204-831-2525      204-832-0619
                                              Winnipeg, MB R3J 0L3
                                              300 Booth Drive
 Winnipeg          Grace General Hospital                                204-837-0137      204-837-0360
                                              Winnipeg, MB R3J 3M7
                                              MS #559 K,
 Winnipeg          Health Sciences Centre     820 Sherbrook Street       204-787-3508      204-787-1503
                                              Winnipeg, MB R3A 1R9
                   Misericordia               99 Cornish Avenue
 Winnipeg                                                                204-788-8225      204-772-9920
                   Health Centre              Winnipeg, MB R3C 1A2
                   Riverview                  1 Morley Avenue
 Winnipeg                                                                204-478-6233      204-478-6272
                   Health Centre              Winnipeg, MB R3L 2P4
                   Seven Oaks                 2300 McPhillips Street
 Winnipeg                                                                204-632-3250      204-694-9795
                   General Hospital           Winnipeg, MB R2V 3M3
                   St. Boniface               L4006 - 409 Tache Avenue
 Winnipeg                                                                204-237-2470      204-237-2494
                   General Hospital           Winnipeg, MB R2H 2A6




                                                                                                   Appendix	2
4 of  • Manitoba Transfusion Quality Manual for Blood Banks                            Version 2 • June 2007
                                           Appendix	2:
Facility Contact List                                                                     Version 2.0
Location          Facility                 Address                     Telephone           Fax Number
                  Victoria                 2340 Pembina Highway
Winnipeg                                                               204-477-3326        204-269-1173
                  General Hospital         Winnipeg, MB R3T 2E8
                  Canadian
                                           777 William Avenue
Winnipeg          Blood Services-                                      204-789-1091        204-779-8593
                                           Winnipeg, MB R3E 3R4
                  Crossmatch Lab
                  Canadian
                                           777 William Avenue
Winnipeg          Blood Services-                                      204-789-1086        204-779-8593
                                           Winnipeg, MB R3E 3R4
                  Accession Lab
                  Canadian
                  Blood Services-          777 William Avenue
Winnipeg                                                               204-789-1034        204-774-2956
                  Blood Product            Winnipeg, MB R3E 3R4
                  Management
                                           Box 280,
                  Winnipegosis &           230 Bridge Street
Winnipegosis                                                           204-656-4711        204-656-4402
                  District Health Centre   Winnipegosis, MB
                                           R0L 2G0




Appendix	2
Version 2 • June 2007                              Manitoba Transfusion Quality Manual for Blood Banks •  of 
                                 Appendix	3:
Glossary                                                                          Version 2.0
 Term                      Definition
                           Surveillance system used by Manitoba Health to track and
 Adverse Event Reporting   monitor transfusion reactions to blood, blood components
 System (AERS)             and derivatives. Part of Public Health Agency of Canada’s
                           Transfusion Transmitted Injuries Surveillance System (TTISS).
                           An individual who receives health care services without
 Ambulatory/outpatient
                           being admitted to a health care facility.
 Authorized Health Care    A person trained, licensed and authorized to provide
 Provider                  health care in Manitoba.
                           A bona fide student of nursing registered in an approved
 Authorized Nursing
                           nursing education and training program authorized to
 Student
                           train in a given facility.
                           A registered nurse who is registered on the register of
                           registered nurses (extended practice) and where the
                           Authorized practitioner is an employee of a Regional
 Authorized Practitioner   Health Authority or health care facility who is permitted to
                           do so by written policy of the authority or facility. As per
                           the Registered Nurses Act (Extended Practice Regulation,
                           43/2005).

                           A refrigerator that meets transfusion medicine regulatory
                           requirements (e.g. fan for circulating air, or of a capacity
                           and design to ensure that the proper temperature is
 Blood Bank Refrigerator
                           maintained throughout, and equipped with automatic
                           temperature recording and an audible alarm) to store
                           blood, blood components or derivatives.

                           A department in a facility that performs transfusion
 Blood Bank
                           related activities but does not perform crossmatching.
 BTS (Blood Transfusion    A department in a facility that performs transfusion
 Service)                  related activities and also performs crossmatching.
                           A periodic scheduled activity to check and maintain
 Calibration               the accuracy of all measurement functions against
                           a known standard.
                           Transfusion recipient experiences symptoms characterized
 Circulatory Overload      by dyspnea, cyanosis, orthopnea hypertension or congestive
 (TACO)                    heart failure during or within 6 hours of completion of
                           a transfusion.
 Collection Date           The collection date of the blood or blood component(s).



Appendix	3
Version 2 • June 2007                   Manitoba Transfusion Quality Manual for Blood Banks • 1 of 
                                             Appendix	3:
Glossary                                                                              Version 2.0
 Term                                Definition
                                     A therapeutic component of blood intended for transfusion
                                     (e.g., red cells, granulocytes, platelets, cryoprecipitate
                                     or plasma) that can be prepared using equipment
 Component
                                     and techniques available in a blood centre.
                                     Note: Such equipment and techniques can include
                                     centrifugation, filtration or freezing.
                                     An approach to quality management that builds upon
                                     traditional quality assurance methods by emphasizing the
 Continuous Quality                  organization and systems by focusing on process rather
 Improvement                         than the individual. It recognizes both internal and external
                                     “customers” and it promotes the need for objective data
                                     to analyze and improve processes.
                                     A method used to detect incompatibilities between donor
 Crossmatch
                                     and recipient blood prior to transfusion.
                                     The date the blood, blood component or derivative
 Date Issued
                                     is released from the blood bank.
                                     The date the blood, blood component or derivative
 Date of Final Disposition
                                     is at a final disposition.

                                     Sterile solutions of a specific protein(s) derived from blood
                                     or by recombinant technology (eg: human serum albumin,
 Derivative                          plasma protein fraction, immunoglobulin preparations,
                                     and coagulation products (factors VIII and IX, fibrinogen,
                                     anti-thrombin III, etc.).

                                     The last day that the blood, blood component or derivative
                                     may be used. If no time is documented, the product expires
 Expiry Date
                                     at midnight. If no day is documented, midnight on the last
                                     day of the month.
                                     A band worn on the patient’s body that has identifying
                                     information . The information must include at minimum
 Identification Band
                                     the patient’s full name (last name, first name), date
                                     of birth and PHIN or unique identifier.
                                     Red Blood Cells (RBC) coated with human IgG antibody
                                     prepared by incubating D-positive RBC’s with potent anti-
 IgG Coombs Control Cells            D. They are used to ensure that the Antiglobulin Test with
                                     negative results are not false negative because of AHG
                                     reagent inactivation.




                                                                                              Appendix	3
2 of  • Manitoba Transfusion Quality Manual for Blood Banks                       Version 2 • June 2007
                                   Appendix	3:
Glossary                                                                             Version 2.0
 Term                        Definition
                             1) The blood, blood component or derivative has not
                                exceeded expiry date and/or timeframe as documented
 Indate                         and defined by the manufacturer or BTS
                             2) The crossmatch done for the unit is within
                                the timeframe as defined by the BTS.
                             The infusion of blood, blood component or derivative
 Infusion
                             directly into the recipient’s bloodstream.
 Issue                       To release for clinical use (transfusion).
                             The ledger/logbook/lab log record is a form developed
                             for the BTS/blood bank to record patient demographics,
 Issue/ Transfusion Record   the issue and transfusion status of recipient and blood,
 (lab log)                   blood component and derivatives. These records shall
                             include final disposition of blood, blood components
                             or derivatives.
                             The unique number assigned by the manufacturer when
 Lot Number                  preparing derivative products. This number is located on
                             both the box and the vial.
                             The company or facility that prepares blood, blood
 Manufacturer                components or derivatives (e.g. Bayer, Baxter, Canadian
                             Blood Services, etc..).
 Medical Record Number       A unique identifier associated with a patient’s health
 (MRN)                       care record.
 MTS                         Micro Typing Systems Inc.
 Neonate                     An infant younger than four months of age.
                             A person who is registered as a registered nurse under
 Nurse                       The Registered Nurses Act, Chapter R40, Continuing
                             Consolidation of the Statutes of Manitoba (CCSM)
                             A person who is registered as a registered nurse (extended
 Nurse (Extended Practice)   practice under Extended Practice Regulation, Manitoba
                             Regulation 43/2005).
                             The last day or time in which the blood unit, component
 Outdate (crossmatch)        or derivative is considered suitable for transfusion or
                             infusion.
 Personal Health
 Identification Number       A unique 9 digit number assigned by Manitoba Health.
 (PHIN)


Appendix	3
Version 2 • June 2007                      Manitoba Transfusion Quality Manual for Blood Banks • 3 of 
                                             Appendix	3:
Glossary                                                                              Version 2.0
 Term                                Definition
                                     The outward expression of genes (e.g: blood type). On
 Phenotype                           blood cells, serologically demonstrable antigens constitute
                                     the phenotype.
                                     Person drawing the specimen of blood for laboratory tests.
 Phlebotomist                        This may be an RN, MD, medical laboratory technologist
                                     or technician trained in phlebotomy.
                                     Pre-admission clinic is a pre-admission assessment of
                                     patients scheduled to undergo an elective procedure. This
                                     pre-admission assessment may be performed by staff of
 Pre-admission Clinic (PAC)
                                     more than one discipline or a set of clinics, each run by
                                     a separate discipline, but taking place
                                     at the same time.

 Primary Health Care                 Health care professional who is the prime clinical point
 Provider                            of contact with the patient within the health care system.

                                     Transport material (e.g. container, plastic bag, etc.) used
                                     to transport blood, blood products or derivatives within
 Protective Covering
                                     a facility to prevent spillage in the event of inadvertent
                                     breakage during transport.
                                     To isolate non-conforming blood, components, tissues,
 Quarantine
                                     derivatives or materials to prevent their distribution or use.
                                     Coin-like stacking of red blood cells in the presence
 Rouleaux
                                     of plasma expanders or abnormal plasma proteins.
                                     When the blood, blood component or derivative is shipped
 Shipped
                                     to another facility.
                                     The Special Access Programme (SAP) provides access to non-
 Special Access Programme
                                     marketed drugs for practitioners treating patients with
  *(Special Product Release
                                     serious or life-threatening conditions when conventional
 (SPR)
                                     therapies have failed, are unsuitable or unavailable.
 *This term is used in the
                                     • The treating physician, physician delegate or authorized
 CBS Clinical Guide to
                                         practitioner must seek documented permission from
 Transfusion
                                         Health Canada.

                                     The numerical code that is located on the label of all blood,
 Supplier / Centre Code
                                     blood components units supplied by a national supplier (CBS).




                                                                                              Appendix	3
4 of  • Manitoba Transfusion Quality Manual for Blood Banks                       Version 2 • June 2007
                               Appendix	3:
Glossary                                                                         Version 2.0
 Term                     Definition
 Transfusion Associated
 Circulatory Overload     See Circulatory Overload
 (TACO)
                          An inscription, attached to or accompanying a blood unit,
                          component or derivative for identification and information
 Tag                      about the contents, storage requirements, expiration date,
                          cautionary statements or indications for use as well as
                          recipient demographics.

                          Transfusion Related Acute Lung Injury is defined as a
                          syndrome where a transfusion recipient experiences acute
                          respiratory insufficiency and X-ray findings are consistent
 TRALI
                          with bilateral pulmonary edema. There is no other evidence
                          of cardiac failure or cause for respiratory failure during
                          or within 6 hours of completion of transfusion.


                          The series of events comprising the requesting of blood or
                          blood components for transfusion, taking pre-transfusion
                          blood samples, laboratory practices, collection and
 Transfusion
                          administration of blood or blood components, monitoring
                          the transfused patient, managing an adverse event and
                          documenting the transfusion events.

                          T&S: Testing of patient specimen to determine the patient’s
                          ABO and Rh type and screening for the presence of atypical
 Type and Screen (T&S)    red cell antibodies in the plasma.
                          If a clinical need arises for blood products, the indate
                          specimen can be crossmatched later, when/if required.
                          A number or alpha-numeric sequence which identifies
 Unique Identifier
                          a patient.
                          Sometimes called a serial donation or donor unit number
 Unit Number
                          on the label of the blood unit.




Appendix	3
Version 2 • June 2007                  Manitoba Transfusion Quality Manual for Blood Banks •  of 
                                  Appendix	4:
Products used by the Manitoba Bleeding Disorders Program:

Factor VIII
   • Kogenate FS® (Recombinant)
   • Recombinate (Recombinant)
   • Advate (Recombinant)
   • Humate P® FVIII/vWF (Plasma Derived)
   • Helixate P® FS
Factor IX
   • BeneFix® (Recombinant)
   • Immunine® (Plasma Derived)
Factor XIII
   • Fibrogammin® P (Plasma Derived)
Factor VIIa
   • NiaStase® (Recombinant)




Appendix	4
Version 2 • June 2007                  Manitoba Transfusion Quality Manual for Blood Banks • 1 of 1
                                      Appendix	5:
  Product Descriptions                                                                   Version 2.0
                        Fresh and Frozen Blood and Blood Components
           Component
                                         Action                Storage               Administration
           Description

   AS-3 RBC, LR                  •   Increases oxygen       1 to 6°C             •    Set: standard
   • Collected into CP2D             carrying capacity                                blood set or Y
     with AS-3 additive              of the blood to        AS-3: 42 days             type set with
                                     the tissues                                      170 micron
   Whole Blood, LR               •   Leukocyte              CPDA-1: 35                filter
   • Collected into CP2D             filtration             days                 •    Rate of
     or CPDA-1                       minimizes febrile                                infusion:
   • Collected for                   transfusion            CP2D: 21 days             as patient
     autologous and                  reactions due                                    can tolerate
     directed donations              to white cell                                    but must be
                                     antibodies,                                      specified by a
   RBC, Deglycerolized, LR           and reduces            1 to 6°C                  physician and
   • Collected into CP2D.            risk of CMV                                      infused within
   • Frozen with glycerol            transmission.          Less than                 4 hrs
     additive                                               24 hrs after
   • Stored frozen for up        Whole Blood:               processing
     to 10 years. Must be        • Contains red
     thawed and washed to          blood cells
     remove glycerol prior         and plasma
     to transfusing.             • Blood volume
   • Collected for patients        expander
     with rare blood types,      • Source of
     multiple red cell             plasma proteins
     antibodies or allo-           with oncotic
     antibodies to a high          properties
     incidence antigen           • Source of
                                   non-labile
   RBC, Washed, LR                 coagulation
   • Collected into CP2D/          factors
     AS-3 additive, CP2D
     or CPDA-1                   RBC, Washed:
   • Removal of plasma           • Minimizes febrile
     constituents                  and allergic
     (antibodies,                  transfusion
     complement, proteins)         reactions.
     or additives (AS-3)
     through washing.

  LR=Leukocyte Reduced by Filtration, < 5X106 leukocytes per bag after filtration


Appendix	5
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 1 of 8
                                             Appendix	5:
Product Descriptions                                                                     Version 2.0
          Component
                                             Action               Storage            Administration
          Description
 Fresh Frozen                        •   Source of labile      Facilities:       •    Set: standard
 Plasma, LR                              (V and VIII)          -18°C or colder        blood set or Y
 • Separated from                        and non-labile        for 12 months.         type set with
    Whole Blood, LR                      coagulation                                  170 micron
 • Frozen within                         factors               After                  filter
    8 hrs of collection              •   Blood volume          Thawing:          •    Rate of
 • Contains a minimum                    expander              1 to 6°C for           infusion:
    of 0.70 IU/mL of FVIII           •   Source of             up to 24 hrs.          as patient
                                         plasma proteins                              can tolerate
                                         with oncotic                                 but must be
                                         properties                                   specified by a
                                     •   Leukocyte                                    physician and
                                         filtration                                   infused within
                                         minimizes                                    4 hrs
                                         febrile
                                         transfusion
                                         reactions due
                                         to white cell
                                         antibodies,
                                         and reduces
                                         risk of CMV
                                         transmission

 Fresh Frozen Plasma,      •             Source of labile
 Apheresis                               (V and VIII)
 • Not leukocyte reduced                 and non-labile
 • Collected by apheresis,               coagulation
    Trisodium Citrate                    factor
    added during           •             Blood volume
    apheresis process                    expander
 • Frozen within 8 hrs     •             Source of
    of collection                        plasma proteins
 • Contains a minimum                    with oncotic
    of 0.70 IU/mL of FVIII               properties
 • Equivalent to 2 units
    of Fresh Frozen Plasma

LR=Leukocyte Reduced by Filtration, < 5X106 leukocytes per bag after filtration




                                                                                                  Appendix	5
2 of 8 • Manitoba Transfusion Quality Manual for Blood Banks                           Version 2 • June 2007
                                      Appendix	5:
  Product Descriptions                                                                   Version 2.0
           Component
                                        Action                Storage                Administration
           Description
   Platelets, LR                 •   Source of            20 to 24°C for         •    Set: standard
   • Platelets are separated         platelets            up to 5 days.               blood set or Y
      from whole blood           •   Primary role                                     type set with
      (CP2D) then filtered           is to prevent        Must be                     170 micron
      to remove leukocytes           bleeding in          agitated                    filter
   • < 8.3 x105 leukocytes           injured blood        continuously           •    Rate of
      per bag after filtration       vessel walls         during storage.             infusion:
   • Contains at least 55            by forming an                                    as rapidly
      x109 platelets per unit        aggregate at                                     as patient
      suspended in 40-70 mL          the site of                                      can tolerate
      of plasma                      injury                                           but must be
                                 •   Leukocyte                                        specified by a
   Platelets, Apheresis, LR          filtration                                       physician and
   • Platelets are collected         minimizes                                        infused within
      by apheresis, with             febrile                                          4 hrs.
      separation of                  transfusion
      leukocytes and                 reactions due
      platelets during the           to white cell
      process                        antibodies,
   • < 5x106 residual                and reduces
      leukocytes per bag             risk of CMV
   • Contains at least               transmission
      300x109 platelets per
      unit suspended in 200-
      400 mL of plasma
   • May also be HLA
      matched for patients
      with anti-HLA
      antibiodies who
      are refractory to
      platelets from random
      unmatched donors.

  LR=Leukocyte Reduced by Filtration, < 5X106 leukocytes per bag after filtration




Appendix	5
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks • 3 of 8
                                             Appendix	5:
Product Descriptions                                                                      Version 2.0
        Component
                                            Action                Storage            Administration
        Description
 Cyroprecipitated             •        Source of               Facilities:       •    Set: standard
 AHF, LR                               FVIII, FXIII,           -18°C or colder        blood set or Y
 (cryoprecipitate)                     vonWillebrand’s         for 12 months.         type set with
 • Fresh frozen plasma,                Factor and                                     170 micron
     LR, is thawed at 1-               fibrinogen              After                  filter
     6°C then centrifuged. •           Leukocyte               Thawing:          •    Rate of
     The supernatant                   filtration              20 to 24 °C for        infusion:
     plasma is removed                 minimizes febrile       up to 4 hrs.           as rapidly
     and the insoluble                 transfusion                                    as patient
     cryoprecipitate                   reactions due                                  can tolerate
     remaining is                      to white cell                                  but must be
     refrozen.                         antibodies, and                                specified by a
 • < 5x106 leukocytes                  reduces risk of                                physician and
     per bag after                     CMV transmission                               infused within
     filtration                                                                       4 hrs
 • Contains a minimum
     of 80 IU FVIII (FVIII:C)
     units
 • Contains at least
     150 mg fibrinogen
 • Suspended in 5-15
     mL of plasma

LR=Leukocyte Reduced by Filtration, < 5X106 leukocytes per bag after filtration




                                                                                                  Appendix	5
4 of 8 • Manitoba Transfusion Quality Manual for Blood Banks                           Version 2 • June 2007
                                       Appendix	5:
Product Descriptions                                                                     Version 2.0
                                          Derivatives
         Description                     Action                 Storage             Administration
 Albumin                         5%:                                            •    Set: 15 micron
 • Solution of albumin           • Colloid replacement                               filter supplied
    prepared from pooled         • Blood volume expander                             by BTS. If
    human plasma                 25%:                                                product is
 • Product supplied in           • Colloid replacement                               supplied in a
    bottles, available as:       • Promotes diuresis in                              bottle then set
     • 5% - 250 mL                 certain conditions                                must be vented
     • 25% - 100 mL                (e.g. liver disease                          •    Rate of
 • Salt poor, sodium               with edema)                                       infusion:
    content 130-160 mmol                                                             as patient
 • Solvent/detergent                                                                 can tolerate
    treated                                                                          but must be
                                                                                     specified by
 CMVIG: Cytomegalovirus          • Source of passive IgG                             physician and
 • Immune Globulin                 antibody to CMV                                   infused within
  •   Solution of specific       • Provides                                          4 hrs.
      gamma globulin prepared      post exposure                                •    Dosage:
      from pooled human            prophylaxis (passive                              calculated by
      plasma from donors           immunization) and                                 body weight
      selected for high titres     treatment of CMV
      of antibody to CMV           infections in severely
  •   Product supplied             immunocompromised
      in 2.5g                      patients such as
  •   Solvent/detergent            transplant recipients
      treated


 HBIG: Hepatitis B          •       Source of passive IgG                       •    Intramuscular
 Immune Globulin                    antibody to Hepatitis B                     •    Dosage:
  • Solution of specific    •       Provides                                         calculated by
    hyperimuune globulin            post exposure                                    body weight
    prepared from pooled            prophylaxis (passive
    human plasma from               immunization)
    donors selected for             to Hepatitis B
    high titres of antibody         surface antigen
    to Hepatitis B
  • Product supplied
    in 0.5 mL, 1.0 mL,
    5 mL doses
  • Solvent/detergent
    treated


Appendix	5
Version 2 • June 2007                          Manitoba Transfusion Quality Manual for Blood Banks •  of 8
                                             Appendix	5:
Product Descriptions                                                               Version 2.0
         Description                       Action              Storage       Administration
ISG: Immune Serum                    • Source of                         •   Intramuscular
Globulin                               passive IgG                       •   Dosage:
• Solution of gamma                    antibody                              calculated by
   globulin prepared                 • Provides post                         body weight
   from pooled human                   exposure
   plasma                              prophylaxis
• Product supplied in                  (passive
   bottles, available as 5             immunization)
   mL or 10 mL dose                    for certain
• Solvent/detergent                    infectious
   treated                             diseases e.g.
                                       Hepatitis A
IVIG: Intravenous                    • Source of                         •   Set: 15 micron
Immune Globulin                        passive IgG                           filter supplied by
• Solution of gamma                    antibody                              BTS. If product
   globulin prepared                 • Provides                              is supplied in a
   from pooled                         prophylaxis                           bottle then set
   human plasma                        (passive                              must be vented.
• Modified for                         immunization)                     •   Rate of infusion:
   intravenous use                     in immune                             as patient can
• Product supplied in                  deficiency                            tolerate but must
   bottles, available as               conditions                            be specified by
   1.0 g, 2.5 g, 5.0 g,              • Used to treat ITP                     physician and
   10.0 g, or 20.0 g dose                                                    infused within 4 hrs
• Solvent/detergent                                                      •   Dosage:
   treated                                                                   calculated by
                                                                             body weight
RhIG: Rh Immune                     • Source of                          •   Intramuscular:
Globulin (WinRho®)                    passive Anti-D                         pregnancy
• Specific gamma                    • Prevents                           •   Intravenous:
   globulin prepared                  sensitization to                       other uses
   from pooled human                  the D antigen                      •   Rate of infusion:
   plasma from donors                 in Rh negative                         as patient can
   selected for high titres           patients                               tolerate but must
   of Anti-D                        • Used to treat                          be specified by
• Lyophilized product                 ITP in Rh                              physician and
   requires reconstitution            positive patients                      infused within
• Available as: 120                                                          4 hrs
   mcg, 300 mcg,
   1000 mcg dose
• Solvent/detergent
   treated

                                                                                            Appendix	5
 of 8 • Manitoba Transfusion Quality Manual for Blood Banks                     Version 2 • June 2007
                                    Appendix	5:
Product Descriptions                                                                 Version 2.0
            Description                  Action                Storage        Administration
TIG: Tetanus Immune Globulin      • Source of passive                         •   Intramuscular
• Solution of specific              IgG antibody                              •   Dosage:
   hyperimmune globulin             to the toxin                                  calculated by
   prepared from pooled             produced by the                               body weight
   human plasma from donors         tetanus organism,
   immunized with tetanus           Clostridium tetani
   toxoid                         • Provides post
• Product supplied in               exposure
   250 unit dose syringe.           prophylaxis (passive
• Solvent/detergent treated         immunization) to
                                    the tetanus toxoid

VZIG: Varicella Zoster Immune     • Source of passive
Globulin                            IgG antibody to
• Solution of specific              Varicella Zoster
   hyperimmune globulin           • Provides post
   prepared from pooled             exposure
   human plasma from donors         prophylaxis (passive
   selected for high titres of      immunization)
   antibody to Varicella Zoster     to Varicella Zoster
• Product supplied as 125           (chicken pox) for
   or 625 IU                        patients at risk
• Solvent/detergent treated         of developing
                                    complications
                                    from the disease

HBV: Hepatitis B Vaccine          • Vaccine for                               •   Intramuscular
• Non-infectious inactivated        immunization                              •   Dosage:
   subunit viral vaccine            against infection                             calculated by
   derived from surface             caused by hepatitis                           body weight
   antigen of hepatitis B virus     B virus
• Product supplied as
   0.5 and 1.0 mL

Pentastarch (Pentaspan)           • Blood volume                              •   Set: standard
• 10% pentastarch in 0.9%           expander                                      IV set
  sodium chloride                                                             •   Rate of
• Product supplied in 250                                                         infusion:
  or 500 mL bag                                                                   as patient
                                                                                  can tolerate
                                                                                  but must be
                                                                                  specified by a
                                                                                  physician

Appendix	5
Version 2 • June 2007                      Manitoba Transfusion Quality Manual for Blood Banks •  of 8
                                             Appendix	5:
Product Descriptions                                                                   Version 2.0
             Description                           Action          Storage       Administration
 Factor VIII (Recombinant)                 • Source of FVIII                 •   Set: IV infusion
  • Freeze dried concentrate               • Prevention                          set (usually a 25
    produced by recombinant                  or control of                       gauge butterfly)
    DNA technology                           bleeding for                        supplied by
  • Lyophilized product                      patients with                       BTS. If product
    requires reconstitution                  proven FVIII                        is supplied in
  • Specific activity (IU)                   deficiency                          a syringe then
    is stated on the label                   (Hemophilia A)                      infuse using IV
                                                                                 push.
 Factor IX (Recombinant)                    •   Source of FIX                •   Rate of
  • Freeze dried concentrate                •   Prevention                       infusion: Must
    produced by recombinant                     or control of                    be specified
    DNA technology                              bleeding for                     by physician.
  • Lyophilized product,                        patients with                    Usually entire
    requires reconstitution                     proven FIX                       dose is given in
  • Specific activity (IU) is                   deficiency                       5-10 minutes
    stated on the label                         (Hemophilia                      or less, or by
                                                B, Christmas                     continuous
                                                Disease)                         infusion.
                                                                             •   Dosage:
 Factor IX (Human)                         • Source of FIX                       calculated by
 • Freeze dried concentrate                • Prevention                          body weight
    prepared from pools of                   or control of
    human plasma                             bleeding for
 • Lyophilized product,                      patients with
    requires reconstitution                  proven FIX
 • Specific activity (IU)                    deficiency
    is stated on the label                   (Hemophilia
 • Solvent/detergent treated                 B, Christmas
                                             Disease)

 Anti-inhibitor Coagulation     •               Source of
 Complex (FEIBA)                                FVIII inhibitor
 • Freeze dried concentrate                     bypassing
   prepared from pools of                       activity
   human plasma                 •               Prevention
 • Lyophilized product requires                 or control of
   reconstitution                               bleeding for
 • Specific activity (IU)                       patients with
   is stated on the label                       inhibitors in
 • Solvent/detergent treated                    proven FVIII or
                                                FIX deficiencies



                                                                                              Appendix	5
8 of 8 • Manitoba Transfusion Quality Manual for Blood Banks                       Version 2 • June 2007
                                     Appendix	6:
Product Mnemonics                                                                   Version 1.0
The following are short form notations of blood, blood components,
derivatives and product modifiers.
Note: This is only a suggested list of mnemonics, follow facility policies and
procedures where applicable.

Table 1 Blood and Blood Components
                    Description                Mnemonic
 Cryoprecipitate                               CRYO
 Cryosupernatant Plasma                        CSP
 Fresh Frozen Plasma                           FFP
 Fresh Frozen Plasma - Apheresis               AFFP
 Frozen Plasma                                 FP24
 Platelets                                     PLT
 Platelets - Apheresis                         APLT
 Red Blood Cells                               RBC




Appendix	6
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
                                             Appendix	6:
                                                                      Version 1.0
  Table 2 Derivatives
                       Description                         Mnemonic
    Alpha 1 Proteinase Inhibitor                           A1PI
    Antithrombin III                                       ATIII
    C1 Esterase Inhibitor                                  C1EI
    Factor VII Concentrate                                 FVII
    Recombinant Factor VIIa (NiaStase®)                    rFVIIa
    Factor VIII Concentrate                                FVIII
    Factor IX Concentrate                                  FIX
    Factor XI Concentrate                                  FXI
    Factor XIII Concentrate                                FXIII
    Fibrin Sealant                                         FS
    Fibrinogen                                             FIB
    FVIII Anti Inhibitor Product                           FEIBA
    Hepatitis B Immune Globulin                            HBIG
    Immune Globulin                                        IG
    Immune Serum Globulin                                  ISG
    Intravenous Immune Globulin                            IVIG
    Rabies Immune Globulin                                 RaBIG
    Rh Immune Globulin                                     RhIG
    Tetanus Immune Globulin                                TIG
    Varicella Zoster Immune Globulin                       VZIG

  NOTE:
  Company or brand names for other products are not included because they can
  change frequently. For example: WinRho® is reported as RhIG, Kogenate FS® is
  reported as FVIII, etc.




                                                                                  Appendix	6
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks           Version 2 • June 2007
                                      Appendix	6:
Table 3 Product Modifiers                                                          Version 1.0
                        Description             Mnemonic
 Deglycerolized                                 D
 Directed                                       DIR
 Divided                                        DIV
 Intended Use Donor Autologous                  AUTO
 Irradiated                                     IRR
 Low Volume                                     LV
 Negative for anti-CMV                          CMV

NOTE:
        •   Modifiers describe attributes, special testing and modifications of blood
            products. They indicate what has been done to a blood product by the
            blood supplier.
        •   Modifiers are added to the product mnemonic to describe the blood component
            preparation or characteristic.
        •   Example:”DIV” RBC is a red blood cell unit that has been divided (split
            or aliquoted) into two or more bags.




Appendix	6
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                          Appendix	7:
CBS Progesa Blood and Blood Component Codes and Mnemonics
                                                                                            Version 2.0
 Component         Text                                Mnemonic         Shelf        Shelf Life Required
 Code                                                                   Life In      In Hours Modifier
                                                                        Days
 01460             CPDA-1 Whole Blood LR               CPDA1 WL         35 Days

 04730             AS-3 Red Blood Cells LR             AS3 RL           42 Days


 44730             AS-3 Red Blood Cells                CG3DELAUTO 42 Days
                   leukoreduced

 34731             AS-3 Red Blood Cells LR,            AS3 RL1          42 Days
                   Divided-1

 34732             AS-3 Red Blood Cells LR,            AS3 RL2          42 Days
                   Divided-2

 34733             AS-3 Red Blood Cells LR,            AS3 RL3          42 Days
                   Divided-3

 05730             AS-3 Red Blood Cells LR,            AS3 RLI          28 Days                   00044
                   Irradiated

 35731             AS-3 Red Blood Cells LR, Divided-   AS3 RL1I         28 Days                   00044
                   1, Irrad

 35732             AS-3 Red Blood Cells LR, Divided-   AS3 RL2I         28 Days                   00044
                   2, Irrad

 35733             AS-3 Red Blood Cells LR, Divided-   AS3 RL3I         28 Days                   00044
                   3, Irrad

 05360             CPDA-1 Red Blood Cells LR,          CPDA1 RLI        28 Days                   00044
                   Irradiated
 05380             CP2D Red Blood Cells LR,            CP2D RLI         21 Days                   00044
                   Irradiated
 06000             Red Blood Cells LR, Washed          RL WASH                       24 Hours

 06100             Red Blood Cells LR, Washed,         RL WASHI                      24 Hours 00044
                   Irradiated
 06800             Red Blood Cells LR,                 RL DEGLYC                     24 Hours
                   Deglycerolized




Appendix	7
Version 2 • June 2007                            Manitoba Transfusion Quality Manual for Blood Banks • 1 of 3
                                            Appendix	7:
                                                                                         Version 2.0
 Component         Text                                    Mnemonic     Shelf      Shelf Life Required
 Code                                                                   Life In    In Hours Modifier
                                                                        Days
 06400             Red Blood Cells,                        R DEGLYC                24 Hours
                   Deglycerolized

 18201             CP2D Fresh Frozen Plasma LR             CP2D FFPL    365 Days
 18230             CP2D Fresh Frozen Plasma LR             CP2D FFPL    365 Days

 48201             CP2D Fresh Frozen Plasma LR,            CP2D FFPL1   365 Days
                   Divided-1
 48202             CP2D Fresh Frozen Plasma LR,            CP2D FFPL2   365 Days
                   Divided-2
 48203             CP2D Fresh Frozen Plasma LR,            CP2D FFPL3   365 Days
                   Divided-3
 18101             CP2D Frozen Plasma LR                   CP2D FPL24   365 Days
 18770             CPDA-1 Fresh Frozen Plasma LR           CPDA1 FFPL   365 Days

 48771             CPDA-1 Fresh Frozen Plasma LR,          CPDA1FFPL1   365 Days
                   Divided-1
 48772             CPDA-1 Fresh Frozen Plasma LR,          CPDA1FFPL2   365 Days
                   Divided-2
 48773             CPDA-1 Fresh Frozen Plasma LR,          CPDA1FFPL3   365 Days
                   Divided-3
 48770             CPDA-1Fresh Frozen Plasma               PFC1DELAUT   365 Days
                   leukoreduced
 18211             Fresh Frozen Plasma Apheresis           FFP APH      365 Days
 18435             CP2D Cryosupernatant Plasma LR          CP2D CPL     365 Days
 18460             CRYOSUPERNATANT                         SU 2         365 Days
 18872             CP2D Plasma LR                          CP2D PL      365 Days
 18972             CPDA-1 Plasma LR                        CPDA1 PL     365 Days
 12010             Platelets Apheresis                     PLAT PH      5 Days
 12011             Platelets Apheresis, Low Count          PLAT PHLC    5 Days
 12020             Platelets Apheresis, 24hr Expiry        PLAT PH24    blank      24 Hours
 12021             Platelets Apheresis, 24 hr Exp,         PLATPH24LC   blank      24 Hours
                   Low Count
 12610             Platelets Apheresis, Irradiated         PLAT PHI     5 Days                 00044
 12611             Platelets Apheresis, Low Count,         PLAT PHLCI   5 Days                 00044
                   Irrad

                                                                                               Appendix	7
2 of 3 • Manitoba Transfusion Quality Manual for Blood Banks                        Version 2 • June 2007
                                            Appendix	7:
                                                                                               Version 2.0
 Component         Text                                  Mnemonic          Shelf        Shelf Life Required
 Code                                                                      Life In      In Hours Modifier
                                                                           Days
 12620             Platelets Apheresis, 24hr Expiry,     PLAT PH24I        blank        24 Hours     00044
                   Irrad
 12621             Platelets Apheresis, 24hr, Low        PLTPH24LCI        blank        24 Hours     00044
                   Count,Irr
 12710             Platelets Apheresis LR                PLAT PHL          5 Days

 12071             Platelets Apheresis LR                PLAT PHL          5 Days
 12711             Platelets Apheresis LR,               PLAT PHLLC        5 Days
                   Low Count
 12720             Platelets Apheresis LR,               PLAT PHL24        blank        24 Hours
                   24hr Expiry
 12721             Platelets Apheresis LR, 24hr, Low     PLTPHL24LC        blank        24 Hours
                   Count
 12810             Platelets Apheresis LR, Irradiated    PLAT PHLI         5 Days                    00044
 12811             Platelets Apheresis LR,               PLATPHLLCI        5 Days                    00044
                   Low Count, Irrad
 12820             Platelets Apheresis LR,               PLATPHL24I                     24 Hours     00044
                   24hr Exp, Irrad
 12821             Platelets Apheresis LR, 24hr,Low      PLTPL24LCI                     24 Hours     00044
                   Cnt,Irr
 12070             CP2D Platelets LR                     CP2D PLATL        5 Days

 12700             CP2D Platelets LR                     CP2D PLATL        5 Days
 12670             CP2D Platelets LR, Irradiated         CP2DPLATLI        5 Days                    00044
 10300             Cryoprecipitated AHF LR               CRYO AHFL         365 Days
 19070             Cryoprecipitated AHF LR               CRYO AHFL         365 Days
 16451             Granulocytes Apheresis                GRANULO           blank        24 Hours




Appendix	7
Version 2 • June 2007                               Manitoba Transfusion Quality Manual for Blood Banks • 3 of 3
                                               Appendix	8:
                                                                                              Version 1.0
  Minimum         Record Type                    Description                              Z902-04
  Retention                                                                               Reference Std.
  Indefinite      CBS Progesa Patient            Record of patient demographics,          19.1.1
                  Report                         ABO/Rh, testing results and serious      19.6.3.1
                                                 transfusion reaction report.
  Indefinite      Dispensing Log                 Record of patient demographics,          19.1.1
                  Includes:                      blood product information and            19.6.3.1
                                                 disposition (receipt, issue, return,
                  Logbook                        discard, interfacility transfer) and
                  Logsheet                       visual inspection
                  Electronic Record
                  Other: use of CBS Patient
                  Report or Packing Slip
  Indefinite      Traceback/Lookback             All documents related to a lookback      19.6.4.7
                  Requests                       or traceback process
  Indefinite      CBS Correspondence             All blood centre correspondence          19.6.2.6
                  Ie: Inventory Retrievals       related to blood and blood
                                                 components
  Indefinite      Facility Blood Bank            All master copies of superseded          19.6.4.2
                  Manuals                        procedures and manuals
  10 years        Facility records of            Documentation records of each            19.6.4.3
                  employee signature, ID         employee’s signature, ID and
                  and initials                   initials (10 yrs after cessation of
                                                 employment)
  10 years        Facility records of staff      Documentation records of staff           19.6.4.3
                  qualification, training        qualifications, training and
                  and competency                 competency (10 yrs after cessation
                                                 of employment)
  5 years         Adverse Transfusion                                                     19.6.3.3
                  Event
  5 years         CBS Issue Voucher/             Record accompanying stock blood          19.6.2.5 (c)
                  Packing Slip                   products issued from BPM or
                                                 Crossmatch lab at CBS (plasma,
                                                 cryoprecipitate, emergency blood,
                                                 albumin etc.) Record of whole blood
                                                 and blood component inspection
                                                 prior to release
  5 years         Facility records for temp.     Temperatures of storage equipment        19.6.4.1 (a)
                  monitoring                     and related chart recording tracings.
  5 years         Facility QC records of         Documentation of QC/QA of Blood          19.6.4.1 (b)
                  testing/maintenance of         Bank equipment
                  equipment




Appendix	8
Version 2 • June 2007                                Manitoba Transfusion Quality Manual for Blood Banks • 1 of 2
                                            Appendix	8:
                                                                                            Version 1.0
  Minimum         Record Type                    Description                             Z902-04
  Retention                                                                              Reference Std.
  5 years         Proficiency testing            ALQEP and/ or CAP External              19.6.4.1
                  surveys                        Proficiency testing (includes: dates,
                                                 tests performed, observed results,
                                                 interpretations, ID of staff carrying
                                                 out tests and appropriate corrective
                                                 action where applicable)
  5 years         Facility product               Documentation records of blood/.        19.6.4.4
                  complaints                     blood product complaints
  5 years         Facility QA reports and        Documentation records of QA and/        19.6.4.5
                  Internal Audit records         or internal audit findings
  1 year          Hospital Collection            Record of phlebotomist’s signature      10.3.1
                  Record                         and date/time of specimen
                  (XM101, XM104, CM105,          collection
                  IG100)
  1 year          OR Dispensing Logsheets/       Record accompanying blood
                  OR Bloodlist                   products issued to a satellite in the
                                                 OR or other hospital location (may
                                                 not apply to all facilities)
  Indefinite      Transfused White               Retain only if transfused. Should be
                  Hospital Product Chart         placed in patient’s medical record.
                  Copy Tag
  Indefinite      Returned/Discarded             Retain only if Re-Issue Record
                  White Hospital Product         contains documentation of release
                  Chart Copy Tag                 and return within hospital facility
                                                 then must become part of Progesa
                                                 Patient Report.
  3 months        Transfused Pink Blood          Record must be kept indefinitely if
                  Bank Product Chart Copy        this information not documented in
                  Tag                            a dispensing log
  2 months        Transfusion Request            Facility record of request for blood
                  Form                           products for transfusion and reason
                                                 for transfusion (may not apply to all
                                                 facilities).




                                                                                                    Appendix	8
2 of 2 • Manitoba Transfusion Quality Manual for Blood Banks                             Version 2 • June 2007
                                     Appendix	9:
Symbols, Factors and Greek Letters                                                Version 1.0

 Symbol       Name           Factor
 G            giga           109 One billion
 M            mega           106 One million
 k            kilo           103 One thousand
 h            hecto          102 One hundred
 da           deka           101 ten
 d            deci           10-1 One tenth
 c            centi          10-2 One hundredth
 m            milli          10-3 One thousandth
 µ            micro          10-6 One millionth
 n            nano           10-9 One billionth
 p            pico          10-12 One thousand billionth


 <       less than
 >       greater than
 <       less than or equal to
 >       greater than or equal to
 ±       plus or minus
 µg      microgram (one millionth of a gram)
 mg      milligram (one thousandth of a gram)
 mL      milliliter (one thousandth of a liter)
 Kg      kilogram (a thousand grams)

Greek alphabet
alpha      A            a      iota      I        i          rho        R         r
beta       B            b      kappa     K        k          sigma      (         s
gamma      G            g      lambda    L        l          tau        T         t
delta      D            d      mu        M        m          upsilon    Y         y
epsilon    E            e      nu        N        n          phi        F         f
zeta       Z            z      xi        J        j          chi        X         x
eta        H            h      omicron   O        o          psi        C         c
theta      U            u      pi        P        p          omega      V         v




Appendix	9
Version 2 • June 2007                        Manitoba Transfusion Quality Manual for Blood Banks • 1 of 1
References




             RefeRences
References
American Association of Blood Banks Primer of Blood Administration, Bethesda, MD, 2005

Brecher, Mark E., editor. AABB Technical manual. 15th Ed. Bethesda, MD: American Association
  of Blood Banks; 2002.

Callum, J.L., Pinkerton, P.H. Bloody Easy 2: Blood transfusions, blood alternatives, and transfusion
  reactions, A guide to transfusion medicine, 2nd ed. Sunnybrook and Women’s College Health
  Sciences Centre; 2005

Circular of information for the use of blood and blood products. Canadian Blood Services. 2004.

Clinical guide to transfusion medicine. Canadian Blood Services. 2006.

Clinical Transfusion Resource Manual, PBCO Publication number 0203, Provincial Blood
   Coordinating Office. British Columbia, Canada, 2002.

Competency Companion to the Technical Resource Manual for Hospital Transfusion Services,
  B.C. Provincial Blood Coordination Office, 2000.

CSA Standard Z902-04, Blood and Blood Components, Canadian Standards Association, 2004.

CSTM Standards for Hospital Transfusion Services, Version 1. Ottawa, Canada: Canadian Society
  for Transfusion Medicine; September 2004.

Fisher Scientific Catalogue, p1456, 2004/2005.

A Guide for Completing the Transfusion Reaction Investigation Form (CM105), Manitoba Health,
  Provincial Blood Programs Coordinating Office, 2007

Manitoba Transfusion Medicine Best Practice Resource Manual for Nursing. Manitoba Health
  Provincial Blood Programs Coordinating Office, Manitoba, Canada. 2007.

Standards for blood banks and transfusion services. 24th ed. Bethesda, MD: American Association
   of Blood Banks; 2006.

Standards for blood banks and transfusion services. 23rd ed. Bethesda, MD: American Association
   of Blood Banks; 2006.

Technical Resource Manual for Hospital Transfusion Services, B.C. Provincial Blood Coordination
  Office, 2000.

Temperature calibration of Water Baths, Instruments and temperature Sensors, 2nd Edition. NCCLS
  Document 12-A2, Villanova, Pa, 1990.




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