Blood Transfusion Policy - PCD032 by roi15698

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									              Transfusion Policy


           Date: November 2005

           Ref : PCD 032

           Vers : 1


Policy Profile
Policy Reference Number   PCD 032
Version                   1
Status                    Operational
Trust Lead                L Delieu
Implementation Date       November 2005
Last Review Date
Next Formal Review        July 2006
Approval Record
Transfusion Policy                                                 November 2005
Ref: PCD 032(v1)                                               Status : Operational


                         Blood Transfusion Policy - PCD 032

This should be read in conjunction with the following Appendixes

Appendix 1     PCD 032-A1 Useful Information
Appendix 2     PCD 032-A2 Roles and Responsibilities
Appendix 3     PCD 032-A3 Information for Patients and Their Relatives
Appendix 4     PDC 032-A4 Consent to Transfusion
Appendix 5     PCD-A5         Clinical Management of Jehovah’s Witness and others who
               refuse blood transfusion
Appendix 6     PCD 032-A6 Prescribing a Transfusion
Appendix 7     PCD 032-A7 Maximum blood Order Schedule
Appendix 8     PCD 032-A8 Requesting Blood Products
Appendix 9     PCD 032-A9 Sample Collection, Timing and Testing
Appendix 10    PCD 032-A10 Blood Product information
Appendix 11    PCD 032-A11 Guidelines on the Compatibility of Blood Products
Appendix 12    PCD 032-A12 Guidelines for the use of Red Blood Cells
Appendix 13    PCD 032-A13 Guidelines for the Management of Massive Transfusion
Appendix 14    PCD 032-A14 Guidelines for the Use of O Rh D Negative Blood in an
               Emergency
Appendix 15    PCD 032-A15 Autologous Blood Transfusion
Appendix 16    PCD 032-16 Guidelines for the use of Platelets
Appendix 17    PCD 032-17 Guidelines for the use of Fresh Frozen Plasma,
               Cryoprecipitate & Cryosupernatant
Appendix 18    PCD 032-18 Guidelines for the Use of Prothrombin Complex
Appendix 19    PCD 032-19 Guidelines for the Use of Recombinant Factor VIIa
Appendix 20    PCD 032-A20 Guidelines for the Use of Anti D Immunoglobulin
Appendix 21    PCD 032-A21 Collection and Delivery of Blood for Transfusion
Appendix 22    PCD 032-A22 Equipment Used in The Administration of Blood
Appendix 23    PCD 032-A23 Administration of Blood and Blood Products
Appendix 24    PCD 032-A24 Adverse Reactions and Events
Appendix 25    PCD 032-A25 Neonatal Transfusion Policy
Appendix 26    PCD 032-A26 Protocol for Performing Acute Normovolaemic Haemodilution
Appendix 27    PCD 032-A26 Guidelines for the Use of Albumin




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 2 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
                                    Transfusion Policy

Content

1.0    Policy Statement
1.1    What the policy covers
1.2    Policy Holders
1.3    Policy Review
2.0    Scope
3.0    Implementation Plan
4.0    Introduction
5.0    Useful Information
6.0    Roles and Responsibilities
7.0    Information for Patients and Their Relatives
8.0    Consent to Transfusion
9.0    Prescribing a Transfusion
10.0   Requesting Blood Products
10.1   Procedure
10.2   Rationale
11.0   Sample Collection, Timing and Testing
11.1   Rationale
12.0   Patients with Irregular Antibodies:
12.1   Finding that a patient has antibodies
12.2   Antibodies and the provision of blood products
12.3   Antibodies in patients going to theatre.
12.4   Antibodies in pregnancy
13.0   Blood Product information
14.0   Guidelines on the Compatibility of Blood Products
15.0   Guidelines for the use of Red Blood Cells
15.0   Management of Massive Transfusion
15.1   Definition of Massive Blood Loss.
15.2   Aims of patient management.
16.0   Guidelines for the Use of O Rh D Negative Blood in an Emergency
17.0   Autologous Blood Transfusion
17.1   Reduce use of donor blood
17.2   Options
18.0   Guidelines for the use of Platelets
19.0   Guidelines for the use of Fresh Frozen Plasma, Cryoprecipitate & Cryosupernatant
19.1   Alternatives to Fresh Frozen Plasma
20.0   Guidelines for the Use of Anti D Immunoglobulin
20.1   Anti D prophylaxis
21.0   COLLECTION AND DELIVERY OF BLOOD FOR TRANSFUSION
21.1   Procedure
21.2   Rationale
22.0   Equipment Used in the Administration of Blood
23.0   ADMINISTRATION OF BLOOD AND BLOOD PRODUCTS
23.1   Rationale
24.0   Documentation of Blood / Blood Product Administration.
25.0   Adverse Reactions and Events
25.1   Signs and Symptoms
25.2   Management of Acute Transfusion reactions.
25.3   Unconscious patients
25.4   Documenting and Reporting untoward and adverse events and near misses.
25.5   Internal Investigation and external reporting of Incidents
26.0   NEONATAL TRANSFUSION POLICY
27.0   Guidelines for the Use of Albumin
28.0   Training and Education
29.0    Abbreviations
30.0   References


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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 3 of 225
Transfusion Policy                                                     November 2005
Ref: PCD 032(v1)                                                   Status : Operational
Transfusion Policy

1.0 Policy Statement
The policy provides guidance and procedures for the safe and appropriate administration of
blood and blood components according to current national guidelines, to all staff involved in
blood transfusion.

1.1 What the policy covers
The policy includes procedures for ordering, prescribing, collection, administration, of blood
products and the management of the patient – including the reporting of adverse incidence.

1.2 Policy Holders
The policies will be held by the Hospital Transfusion Team on Behalf of the Hospital
Transfusion Committee. In addition information and support will also be available from staff
in the Blood Transfusion Department, the Pathology Blood Bank Manger and the Specialist
Practitioner of Transfusion.

1.3 Policy Review
A programme of audits will ascertain whether these standards are being complied with and
will guide revision of the policy. The policy will be reviewed every 12 months.

2.0 Scope
The policy applies to all staff working for Dartford and Gravesham NHS Trust who are
involved in the administration of blood or blood components and taking blood samples.
It specifies:
• The responsibilities of staff involved in the transfusion process
• The standards that should be adopted for each step in the process
• The management, monitoring and reporting of adverse events.

3.0 Implementation Plan
The transfusion policy, held on Adagio for the availability of all Trust staff, will be promoted
by the Hospital Transfusion Team and Biomedical Scientists when discussing and advising
on transfusion requests.

Relevant parts of the protocol will be presented at regular training sessions for nursing,
support and medical staff.

4.0 Introduction
Transfusion of blood and blood products is an important constituent of patients care.

FAILURE TO OBSERVE PROCEDURES MAY RESULT IN DEATH. THIS IS A CATASTROPHE
THAT IS LARGELY PREVENTABLE.

Blood products are potentially hazardous and should only be given when clinical benefit to
the patients outweighs the risk. Despite constant improvement in transfusion practice, the
most common fault lies in failure to identify the patient properly when taking the original
blood sample or when transfusing the components.

The procedures in this document are for all staff responsible for prescribing, taking samples,
administering, transporting/storing or issuing of blood components.

This policy will incorporate guidelines and recommendations made by the Hospital
Transfusion Team and are approved by the members of the Hospital Transfusion Committee

The documents are based on:

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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 4 of 225
Transfusion Policy                                                     November 2005
Ref: PCD 032(v1)                                                   Status : Operational
   •   Guidelines produced by the British Committee for Standards in Haematology
       (BCSH) in collaboration with the Royal College of Nursing and the Royal College of
       Surgeons. (See section 30.0 References).
   •   The Handbook of Transfusion Medicine (HMSO 2001), produced by the UK Blood
       Transfusion Services.
   •   The Health Service Circular 2002/009, “Better Blood Transfusion”
   •   Serious Hazards of Transfusion Scheme (SHOT)
   •   EU Directives.

This document has a number of comprehensive policies as Appendices relating to the
transfusion process.

5.0 Useful Information
See Appendix 1 (PCD032-A1) for contact names / number, laboratory opening hours etc.

6.0 Roles and Responsibilities
As with most processes within the health service, good transfusion practice requires a multi-
professional approach. Appendix 2 (PCD 032-A2) of this policy defines the roles and
responsibilities of staff involved in the process of Blood Transfusion.

7.0 Information for Patients and Their Relatives
See Appendix 3 (PCD 032-A3)

It is advised that all patients who are to undergo transfusion make an informed choice about
their treatment. In addition, those having a transfusion are more likely to recognise the signs
and symptoms of an adverse reaction if they have knowledge of these before hand.

8.0 Consent to Transfusion
See Appendix 4 and 5 (PCD 032-A4 and PCD 032-A5)

The Patient’s Charter states that patients have a right to know, where possible, about the
treatment they are being offered. This will include the aims, benefits, risk and discomforts of
the proposed treatment and the alternatives available.

Consent to transfuse should be obtained from the patient. This should be recorded in the
patient’s notes. If consent cannot be gained, e.g. the patient is unconscious; this should be
recorded in the patients’ notes.

There will be patients who are not willing to consent to transfusion, the most obvious being
Jehovah’s Witnesses (JWs). The Trust will ensure that Jehovah’s Witnesses beliefs are
acknowledged and respected and that information is provided for the management of these
patients.

In addition there are a growing number of patients who, for a variety of reasons, will be
resistant to transfusion. The risks and advantages of transfusion should be discussed
sensibly and sympathetically with the patient.

9.0 Prescribing a Transfusion
See Appendix 6 (PCD 032 – A6)

Because of the inherent risks associated with transfusion, it is desirable that patient
exposure to donor blood products is minimized and justified.

In all cases, the benefits of transfusing a patient will outweigh the potential risks involved.


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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 5 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
Record in the patients notes the reason(s) for the transfusion and the target to be achieved.

10.0 Requesting Blood Products
See Appendix 7 and 8 (PCD 032-A7 and PCD 032-A8)

All blood products must be prescribed and ordered by medical staff for a named patient. It is
important these staff understand the processes involved in the provision of blood as there
are a number of ways in which blood products can be made available and a breakdown in
the system may delay the provision of blood.

Requests are made on a pathology “Blood Transfusion” pink form, code WOL or by
telephoning the blood bank laboratory or Biomedical Scientist (BMS) On Call.

Where blood is ordered for surgery a Maximum Surgical Blood Order Schedule (MSBOS)
has been agreed. However it does not preclude further blood being requested in response to
specific clinical need.

The MSBOS has been agreed by the appropriate clinical leads and consultants.

10.1 Procedure
The minimum transfusion data-set comprises;
   • Patients First Name, Surname, Hospital Number Date of Birth and Gender.
   • The test required.
   • The product required. Number of Units, date/time required.
   • Diagnosis, Reason for Transfusion.
   • Requesting clinician and consultant.


10.2 Rationale
   • To minimise the risk of identification error.
   • To comply with recommendations in the British Committee fr Standards in
       Haematology (BCSH) Guidelines for The Administration of Blood and Blood
       Components and the Management of Transfused Patients (1999).
   • To comply with Blood Bank Standard Operating Procedures.

11.0 Sample Collection, Timing and Testing
See Appendix 9 (PCD 032-A9)

Sample collection is fundamental to the safety of Blood Transfusion yet it is often left to the
least experienced medical staff. There are strict guidelines from the British Committee for
Standards in Haematology (BCSH) on which this appendix is based.

Inadequately labelled, mislabelled, discrepantly labelled samples and forms, or under-filled
samples will be rejected by the Blood Bank, and will have to be repeated.

11.1 Rationale
   • To minimise the risk of identification error.
   • To comply with recommendations in the BCSH Guidelines for The Administration of
       Blood and Blood Components and the Management of Transfused Patients (1999).
   • To comply with Blood Bank Standard Operating Procedures.

12.0 Patients with Irregular Antibodies:

12.1 Finding that a patient has antibodies

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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 6 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
If, during antibody screening, a patient is found to have antibodies present, antibody
identification process will be carried out. Further samples may be required.

Results will be reported on TPath.

12.2 Antibodies and the provision of blood products
   • Antigen negative blood will be provided for these patients.
   • Additional time may be required to meet the request, though most can be met within
       24 hours.
   • If the request is urgent, the person requesting it will be contacted by phone and
       situation discussed further.
   • If a patient should need a transfusion urgently, before compatible blood is available,
       the Consultant Haematologist can advise on the severity of risk. This risk must be
       balanced with the risk of delaying transfusion.

12.3 Antibodies in patients going to theatre.
   • The blood bank should be made aware of patients with known antibodies who are
       going to theatre, even if the usual MSBOS is group and save only.
   • The blood bank staff will advise on the availability / time required to provide blood
       should it be needed.

12.4 Antibodies in pregnancy
Advice on management of these patients will be in two categories;

   •   Those which are clinically significant to the foetus
              Advice on management will be given by National Blood Service (NBS) via
              Blood Bank.
   •   Those which are clinically significant for the provision of blood products.
              It is important the blood bank is made aware of patients with antibodies
             when they go into labour as blood may not be readily available in an
             emergency situation.

13.0 Blood Product information
See Appendix 10 (PCD 032-A10)

The National Blood Service is responsible for the collection, preparation and testing of blood
products from volunteer donors. Deliveries of the different products are made to the Hospital
Blood Bank on request routinely Monday to Friday, although “ad hoc” deliveries can be
arranged at other times.
This appendix is an information resource on the blood products routinely used at Darent
Valley Hospital.


14.0 Guidelines on the Compatibility of Blood Products
See Appendix 11 (PCD 032-A11)

Understanding the basic principles of blood groups is fundamental to transfusion safety.

ABO groups are of paramount importance, as they are associated with potent antibodies
which, when incorrect blood is transfused, may cause red cell haemolysis, leading to
disseminated intravascular coagulation (D.I.C) renal failure and death.

Rh D type is important as this blood group is extremely immunogenic. It has been shown
that 80% of Rh D negative people receiving a transfusion of Rh D positive cells will produce


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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 7 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
anti D antibodies. This is particularly crucial when transfusing women still capable of child
bearing.

150 Guidelines for the use of Red Blood Cells

See Appendix 12 (PCD 032-A12)

Concerns about the safety of transfusion, in relation to both infectious and non-infectious
complications, the risk of transmission of Creutzfeldt-Jakob disease and the increasing
complexity and cost of the production of blood components show the need for sensible
guidelines for the use of red cells.

Generally the following guidelines should be considered.

•   Hb <4g/dl          Transfusion necessary.
•   Hb 4-7g/dl         Transfusion usually necessary, unless fit and Hb is rising.
•   Hb 7-10g/dl        Transfusion not usually necessary.
•   Hb >10g/dl         Transfusion rarely required.

The amount of blood required to raise a patients Haemoglobin will depend on their size. For
example:

Amount of Haemoglobin in a unit of red cells = approx 60g
Blood volume (70ml/kg in adults)           50kg (3.5)L 60kg (4.2L)          70kg (4.9L)
Increase in Hb after 1 unit transfusion    1.7g/dl        1.4g/dl           1.2g/dl

Appropriateness of red cell transfusion and patient requirement, including any special needs,
will be based on numerous factors. These are outlined in Appendix 12.

15.0 Management of Massive Transfusion
See Appendix 13 (PCD 032-A13)

Massive blood loss presents a serious threat to patient survival. Most practical problems
occur when large volume blood loss occurs suddenly and unexpectedly. Such situations
often create extreme tensions between those attempting to treat the haemorrhage and the
staff supplying the blood or blood components. Poor communication can result in errors and
inappropriate actions being taken or untimely provision of products.

15.1 Definition of Massive Blood Loss.
Massive blood loss is arbitrarily defined as any of the following:
   • When transfusion of more than one whole blood volume in less than 24 hours is
       required. (In adult the estimated volume is 70mls/Kg, equivalent to 8-10 units of
       blood).
   • Loss of more than 50% loss of blood volume within 3 hours.
   • A rate of loss is more than150 mLs/min.

15.2 Aims of patient management.
   • To restore and maintain circulating fluid volume
   • To maintain adequate blood oxygen transport capacity- maintain PCV >20%
   • To maintain haemostasis – platelets >50x109/l, or > 100x109/l if danger of intracranial
       bleeding.
           o achieve surgical control of bleeding, where applicable.
           o Correct any coagulopathy.


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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 8 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational
When treating massive blood loss it is important that the patient receives the appropriate
blood product at the time required. Appendix 13 explains in more detail how and when to
involve the blood bank laboratory, sample requirements and what products should be
ordered.

16.0 Guidelines for the Use of O Rh D Negative Blood in an Emergency
See Appendix 14 (PCD 032-A14)

Emergency issue of O Rh D Negative Blood is available via the blood bank laboratory, for life
threatening emergency, used when there is insufficient time for the blood bank to issue “same
group” blood.

This is a scare resource and is often used inappropriately. In Appendix 14 a flow chart clearly
explains when and when not, this uncrossmatched product is to be used.

17.0 Autologous Blood Transfusion
See Appendix 15 and 26 (PCD 032-A15 and PCD032 – A26)

Autologous blood transfusions are more commonly associated with the surgical setting. The
consideration of the use of autologous blood is a requirement of Health Service Circular
HSC 2002/009 (known as better blood transfusion 2); - appropriate use of blood, and the
“Emergency blood plan” to reduce routine use of blood

Autologous transfusion, as with homologous transfusion, is not without risk, and should be
undertaken with careful consideration and adherence to guidelines.

17.1 Reduce use of donor blood
Making available an alternative to allogeneic blood has a number of benefits including:
   • Reduced reliance on donor blood, which is a diminishing and expensive commodity.
   • For patients, it would prevent transmission of blood borne infections, reduce the
       immunological effects of transfusion and reduced risk of alloimmunisation.

17.2 Options
   • Collect blood from the patient before the operation:
          o Pre- deposit Autologous Donation (PAD)
          o Acute Normovolaemic Haemodilution –see appendix 26 for agreed
             procedure.
   • Collect blood from the patient during the operation:
          o Intra - operative cell salvage
          o Collect & re-infuse –e.g. Solcotrans
          o Collect wash re-infuse via cell savers – e.g. Haemonetics.
   • Collect blood from the patient after the operation:
          o Post operative cell salvage – e.g. Bellovac.

See Appendix 15 (PCD 032-A15) for further information on ways in which the patients own
blood may be used.

18.0 Guidelines for the use of Platelets
See Appendix 16 (PCD 032-A16)

The guidelines in this appendix are based on British Committee for Standards in
Haematology (BCSH) platelet transfusions July 2003. (British Journal of Haematology 122:
10–23)



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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 9 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
Guidance is given for prescribing, administering and providing platelet transfusions. This
includes the appropriate use, special requirements and contra-indications.

19.0 Guidelines for the use of Fresh Frozen Plasma, Cryoprecipitate &
Cryosupernatant
See Appendix 17 (PCD 032-17)

The purpose of this guideline is to assist clinical decisions to transfuse these products so as
to reduce morbidity / mortality associated with major bleeding.

The blood bank will issue these products without a sample IF the patient has been tested for
blood group on at least two occasions.

In the appendix guidance is given for prescribing, administering and providing plasma
products This includes the appropriate use, special requirements, risks, benefits and contra-
indications.

19.1 Alternatives to Fresh Frozen Plasma
See
Appendix 18 (PCD 032–A18) Guidelines for the Use of Prothrombin Complex
Appendix 19 (PCD 032-A19) Guidelines for the Use of Recombinant Factor VIIa

These products are currently not held as a stock item in the blood bank. They may however
play a part in the management of some patients, their planned use being approved by the
Consultant Haematologist.

The appendices describe the products, when their use might be considered, benefits, risks
and contra indications.

20.0 Guidelines for the Use of Anti D Immunoglobulin
See Appendix 20 (PCD 032-A20)

This appendix is based on guidelines published by National Institute for Clinical
Excellence’s Technology Appraisal Guidance No 41 Guidance on the use of routine
antenatal anti-D prophylaxis for RhD-negative women, May 2002. and the Royal College of
Obstetricians and Gynaecologists' 'Green Top' 199guideline: Use of Anti-D Immunoglobulin
for Rh Prophylaxis (AADP). (22) – Revised May 2002




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 10 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational
20.1 Anti D prophylaxis
Anti D prophylaxis is offered to all non-sensitised pregnant women who are Rh D negative
when they are exposed to Rh D positive red cells whether these be foetal maternal
haemorrhage or exposure to blood products.

The treatment is required to prevent women producing anti D antibodies, which might cause
Haemolytic Disease of the Newborn (HDN) in future pregnancies. H.D.N. in its worse form
may result in stillbirth or infants with severe disabilities.

The Appendix covers:

   •   Routine antenatal anti-D prophylaxis (RAADP) (i.e. routine prophylaxis at 28 and 34
       weeks)
   •   Prophylactic anti-D given because of likely sensitisation.

It explains when to prescribe, how to order and how to and when to administer this product
as well as pathology sample requirements.



21.0 Collection and Delivery of Blood for Transfusion
See Appendix 21 (PCD 032-A21)

This appendix gives the location of the blood bank and collection procedure as well as the
“rules” associated with the storage and transport of blood. This includes sending blood off
site e.g. when transferring a patient to another hospital.

Collection of the wrong unit of blood if often identified as the first error implicated when a
patient is transfused an incorrect unit of blood (S.H.O.T. Report). As with all transfusion
associated processes, blood collection must be done correctly.

All porters are trained in collection procedures and should be used for this purpose. Other
personnel will be trained by blood bank staff. Please contact the BMS3* on ext 8501 to
arrange this.

21.1 Procedure
The procedure is detailed in appendix 21. The import things to remember are:
   • Use trained personnel.
   • Do not store blood anywhere other than a blood bank.
   • Bring documentation. e.g. prescription sheet or patient’s notes.
   • Be vigilant in crosschecking all Patient information and Blood product information. If
       in doubt ASK.
   • Only take one unit at a time (unless major emergency)
   • Sign for the unit(s) recording date and time.
   • Transport in the insulated blood boxes provided.

   •   Unused blood should be returned within 30 minutes.

21.2 Rationale
   • To comply with recommendations in the BCSH Guidelines for The Administration of
       Blood and Blood Components and the Management of Transfused Patients (1999).
   • To comply with CNST Standard 7.1.2
   • To minimise the risks associated with “wrong blood product transfused” as described
       in SHOT report.
   • To comply with the requirements of European Directive 2002/98/EC
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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 11 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
   •   To control and document training as required by MHRA and CPA.

22.0 Equipment Used in the Administration of Blood
See Appendix 22 (PCD 032-A22)

Before a transfusion can proceed the appropriate equipment must be available. This
appendix gives information on the cannula, blood giving / administration sets, blood
warmers, pharmaceuticals and blood transfusion etc.

23.0 ADMINISTRATION OF BLOOD AND BLOOD PRODUCTS
See Appendix 23 (PCD 032-A23)

The guidelines in this appendix are based on British Committee for Standards in
Haematology (BCSH), Blood Transfusion Task Force Guidelines, a document which was
produced in collaboration with the Royal College of Nursing and the Royal College of
Surgeons of England.
This document replaces Policy CLOO4 on Adagio.
This is comprehensive guidance for the whole blood / blood product administration process.

23.1 Rationale
   • To comply with recommendations in the BCSH Guidelines for The Administration of
       Blood and Blood Components and the Management of Transfused Patients (1999).
   • To comply with requirements in Health Service Circular 2002/009.
   • To prevent misidentification of the recipient
   • To prevent transfusion of an incorrect unit
   • To prevent transfusion of an expired unit
   • To provide baseline readings in case a reaction occurs.
   • To provide a permanent record of the transfusion.
   • To maintain the audit trail of the units.

24.0 Documentation of Blood / Blood Product Administration.
It is law the (2002/98/EC) that the transfusion of blood products is documented from
donation to final fate. This information must be retrievable for 30 years.

This is fundamental in managing patients in case of a health scare, as in the past with HIV
and Hepatitis C, or for “call backs” due to bacterial contamination or problems with individual
donors. Also, should a patient unexpectedly have an adverse event to transfusion it will be
necessary to identify the donor.

In addition, this information must be in place to defend against claims of clinical negligence.

25.0 Adverse Reactions and Events
See Appendix 25 (PCD 032-A25)
Occasionally some patients experience a reaction due to the transfusion, and occasionally
the transfusion process breaks down which results in an adverse event.

This appendix gives guidance on the appropriate course of action:

25.1 Signs and Symptoms
Those caring for / managing patient care should be familiar with symptoms and clinical
features associated with transfusion reactions.

The most serious reaction is an ABO incompatible transfusion. These are rare, and usually
occur because of a clerical checking error or laboratory error.


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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 12 of 225
Transfusion Policy                                                            November 2005
Ref: PCD 032(v1)                                                          Status : Operational
25.2 Management of Acute Transfusion reactions.
Severe reactions are uncommon but life threatening and must be managed quickly.
In brief, it is suggested that:-

                             Initial Management of Transfusion Reactions
                         (From Handbook of Transfusion Medicine HMSO 2001)
                Symptoms / Signs                                           Procedure

              If a transfusion reaction is suspected, seek medical help straight away

                                                       Slow / stop the transfusion.
                                                       Administer Paracetamol or other antipyretic as
                                                       prescribed.
Patient becomes febrile (>38oC), observations
                                                       Encourage patient to drink cold fluids.
are stable, and is otherwise well.
                                                       If temperature returns to normal after 30 minutes,
                                                       resume transfusion and observe more frequently.

                                                       Slow / stop the transfusion.
Patient suffers a mild allergic reaction such as       Administer antihistamines and / or steroids as
a slight rise in temperature, local flushing, hives    prescribed.
and itching
                                                       Resume transfusion and observe more frequently.

                                                       Stop the transfusion immediately.
Patient suffers an acute transfusion reaction,         Seek medical help straight away.
with fever, chills, tachycardia, hypotension,          Change giving set and commence infusion of
collapse, rigors, flushing, urticaria, pain in bone,   0.9% sodium chloride.
muscle, chest, flank or abdomen, shortness of          Check urine output.
breath, respiratory distress, nausea, generally        Recheck transfusion documentation and unit
feeling unwell or apprehensive, oozing from            details.
wounds or puncture sites, haemoglobinuria.             Inform Blood Bank and take further samples /
                                                       return blood component(s) as requested.
                                                       Stop the transfusion immediately.
                                                       Seek medical help straight away.
Patient suffers a severe allergic reaction, with       Change giving set and commence infusion of
bronchospasm, angioedema, abdominal pain               0.9% sodium chloride.
and / or hypotension.                                  Resuscitate patient as appropriate.
                                                       Inform Blood Bank and take further samples /
                                                       return blood component(s) as requested.

Patient suffers heart failure due to fluid
                                                       Stop the transfusion immediately.
overload, with acute dyspnoea, hypotension,
                                                       Give oxygen and Frusemide.
and / or pulmonary oedema on chest X-ray.


Patient suffers TRALI (Transfusion related acute       Stop the transfusion immediately.
lung injury), with fever, cough, shortness of          Maintain airway.
breath, typical appearance on chest X-ray.             Treat as Acute Respiratory Distress Syndrome.



If a mistake is apparent, inform the Blood Bank at once, as another patient may
be involved in the same incident.

25.3 Unconscious patients
These patients are often difficult to assess and transfusion reactions should always be
considered if there is a change or deterioration in the patient’s condition.


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The appendix gives further information on the various adverse effects of transfusion and how
they might be managed.

25.4 Documenting and Reporting untoward and adverse events and near misses.
All details of the reaction, treatment and investigations must be documented.

It is quite possible for adverse events and near misses to occur without “harming” the
patient.

Although they have not caused harm, they are reportable adverse events.

Investigation of such events will uncover failures in the process or highlight training issues.
Do not ignore them.

25.5 Internal Investigation and external reporting of Incidents
Any unexpected event that has an actual or potential short-term or long-term detrimental
effect on an individual patient or member of staff must be reported according to the Trust’s
Guidelines for Adverse Incident Reporting (Sent to risk management team) and to the Blood
Bank Laboratory.

Incident reporting should include ‘near miss’ episodes involving procedural errors which
were detected in time to prevent a serious complication of blood transfusion, e.g. taking the
blood sample for compatibility testing from the wrong patient or labelling the blood sample
with another patient’s details.

The blood bank will ensure the incident:-
Does not indirectly affect another patient,
Is recorded on TPath if necessary,
Is passed to the Specialist Practitioner of Transfusion for Investigation and reporting.

A member of the Hospital Transfusion Team will report all suspected transfusion-transmitted
infections and TRALI to the National Blood Service.

The Hospital Transfusion Committee (HTC) will review all transfusion-related
reactions and adverse events.

The Hospital Transfusion Team will report the event to ‘Serious Hazards of Transfusion’
(SHOT) and where necessary, to the MHRA.

26.0 Neonatal Transfusion Policy
See Appendix 25 (PCD 032-A25)

These guidelines are based on the document “Transfusion guidelines for neonates and
older children” BMJ 124, 433-453 .

There are many different and special requirements associated with transfusing this patient
group. Because there are so many areas where neonatal transfusion differs from adult
transfusion it warrants separate attention. This appendix discusses the whole transfusion
process in relation to this patient group.

27.0 Guidelines for the Use of Albumin
See Appendix 27 (PCD 032-A27)

At Darent Valley Hospital Albumin products are not under the jurisdiction of the Pathology
Blood Transfusion Department. The products are under the control of Pharmacy. However
the product is derived from human blood and therefore warrants a section in this policy.
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This Appendix outline the indications for use, contraindications and aspects of
administration, adverse effects etc.

28.0 Training and Education
Teaching programmes will be provided by the Specialist Practitioner of Transfusion for all
staff involved in the management of blood transfusion. The programme will include training
related to this policy.

Visits to the Blood Bank Laboratory may be arranged for those involved in the transfusion
process.




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29.0 Abbreviations

AIDS             Acquired immune deficiency syndrome
APTT             Activated partial prothrombin time
BCSH             British Committee for Standards in Haematology
BMS              Biomedical Scientist
BMT              Bone Marrow Transplant
BP               Blood pressure
CJD              Creutzfeldt Jakob Disease
CMV              Cytomegalovirus
CRYO             Cryoprecipitate
CVP              Central venous pressure
DAT              Direct Antiglobulin Test (also known as DCT Direct Coombs Test
DDAVP            Desmopressin
DIC              Disseminated intravascular coagulation
ECG              Electrocardiogram
EPO              Erythropoietin
FBC              Full blood count
FFP              Fresh Frozen Plasma
G&S              Group and save
GvHD             Graft versus host disease
HBV              Hepatitis B virus
HIT              Heparin Induced Thrombocytopenia
HCV              Hepatitis C virus
HIV              Human immunodeficiency virus
HLA              Human lymphocyte antigens
HPA              Human platelet antigen
HTLV             Human T-cell lymphotropic virus
ID Band          Identity wristband
IgG              Immunoglobulin G
INR              International normalised ratio
IUT              Intrauterine transfusion
IV               Intravenous
IM               Intramuscular
JVP              Jugular venous pressure
LVF              Left ventricular failure
MBFFP            FFP which has been virally inactivated with Methylene Blue
MDS              Myelodysplastic syndrome
NBS              National Blood Service
NBUG             National Blood Users Group
PID              Patient identification details
PLT              Platelets
PT               Prothrombin time
PTP              Post transfusion Purpura
RBCs             Red blood cells
Rh D             The D antigen of the Rh blood group system
SAGM             Saline, adenine, glucose and mannitol.
SD plasma        Solvent detergent plasma
SHOT             Serious Hazards of Transfusion
SOP              Standard operating procedure
TACO             Transfusion associated circulatory overload
TA-GVHD          Transfusion associated graft-versus-host disease
TPH              Transplacental Haemorrhage
TRALI            Transfusion related acute lung injury
TTP              Thrombotic Thrombocytopenic Purpura
vCJD             Variant Creutzfeldt Jakob Disease




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30.0 References
British Committee for Standards in Haematology (BCSH) 1990 Guidelines on hospital blood bank documentation
and procedures.
Journal of Clinical and Laboratory Haematology,12, 209-220.

British Committee for Standards in Haematology (BCSH) 1994 Guidelines for the administration of blood
products: transfusion for infants and neonates.
Transfusion Medicine 4, 63-69.

British Committee for Standards in Haematology (BCSH) 1996 Guidelines on gamma-irradiated blood
components for the prevention of transfusion associated graft-versus-host disease.
Transfusion Medicine 6, 261-271

British Committee for Standards in Haematology (BCSH) 1996. Guidelines for pre-transfusion compatibility
procedures in blood transfusion laboratories.
Transfusion Medicine, 6, 273 – 283

British Committee for Standards in Haematology (BCSH) 1999. Guidelines for the administration of blood and
blood components and the management of the transfused patient.
Transfusion Medicine, 9, 227 – 238

British Committee for Standards in Haematology (BCSH) 2001 Guidelines for the clinical use of red cell
transfusions
BJH 2001, 113, 24-31

Guidelines for the use of platelet transfusions 2003
BJH 2003, 122, 10-23

British Committee for Standards in Haematology (BCSH) 2004 Guidelines for the the use of fresh frozen plasma,
cryoprecipitate and cryosupernatant.
BJH 2004 126, 11-28

British Committee for Standards in Haematology (BCSH) Guidelines for compatibility procedures in blood
transfusion laboratories. 2003
Transfusion Medicine,2004, 14, 59-73
                                                                                           rd
Blood Transfusion Services of the United Kingdom (2001). Handbook of Transfusion Medicine 3 Edition
(Ed McClelland, D.B.L.). The Stationery Office, London

European Union Directive 2002/98/EC “Setting standards of quality and safety for the collection, testing,
processing, storage and distribution of human blood and blood components.”

Health Service Circular 1998/224; Better Blood Transfusion Department of Health, Wetherby.

Health Service circular 2002/009; Better Blood Transfusion (2) Department of Health, Wetherby.

The Serious Hazards of Transfusion (SHOT) initiative: The UK approach to haemovigilance.
CME Bulletin Haematology 2000; 3 (2): 35 – 38

SHOT Steering Group 2003 Summery of Annual Report 2001 – 2002

Guidelines for the Blood Transfusion Services in the United Kingdom (Red Book) 6th Edition 2002 The Stationery
Office, London




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                       Transfusion Policy
                          Appendix 1
                       Useful Information


                     Date: November 2005

                     Ref : PCD 032 – A1

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032 – A1
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




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                                    Transfusion Policy
                                       Appendix 1
                                    Useful Information

Content

1.0     Contact numbers
2.0     Blood Bank Laboratory.
2.1     On Call Service
2.1.1   Laboratory
2.1.2   Clinical
3.0     Blood Banks.
4.0     Samples
4.1     Sample Processing
5.0     Stocks held on site
5.1     Urgent O Negative blood (flying squad blood)
5.2     Red Cells
5.3     Fresh Frozen Plasma/Cryoprecipitate
5.4     Platelets
5.6     Other blood products
6.0     Giving Sets
                                    Useful Information

1.0 Contact numbers

Consultant Haematologist             Ralph Ezekwesili       Ext 8505
Haematology SpR.                     annual rotation        Ext 8555 Bleep 546
Blood Transfusion Manager            Shirley Hannam         Ext 8503
Blood Bank, Chief BMS3*              Tina Green             Ext 8501
Specialist Practitioner of Trans.    Leslie Delieu          Ext 4666

Blood Bank Laboratory                                       Ext 8502
On-Call Haematology BMS                                     Bleep via switchboard

Hospital Transfusion Committee
Chair                                Gill Jenner            Ext 8653

2.0 Blood Bank Laboratory.
    • Situated within Pathology on the 3rd floor.
    • Routinely open 09.00hr – 17.00hr Mon – Friday
    • Outside these hours an emergency On Call service is provided.

2.1 On call service
       2.1.1 Laboratory - Many transfusion errors occur “out of hours” (SHOT Report). To
promote the safest practice in the Trust, routine cross-match requests should not be
requested out of hours. For urgent requests please bleep the Haematology BMS via
switchboard.

        2.1.2 Clinical- Contact the Clinical Haematologist via switchboard.

3.0 Blood Banks.
    • Pathology, Transfusion Laboratory. For all blood reserved for patients.
       09.00hr – 17.00hr daily.
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    •   Pathology, external blood bank. Located 3rd floor street, next to Pathology
        reception / opposite Juniper ward. Swipe access required. For all blood reserved for
        patients for whom overnight transfusion may be required.
    •   Haematology Oncology Suite. Opposite ward reception desk. For Oncology
        Patients only. No overnight/weekend storage.

NB blood should NEVER be stored anywhere else within the Trust.

4.0 Transfusion Samples
        Routine Test                Adult Sample             Paediatric Sample
Group and Save                  6 ml EDTA (pink top)     1.5 ml EDTA (purple top)
Crossmatch                      6 ml EDTA (pink top)     1.5 ml EDTA (purple top)
Antenatal Group and Screen      6 ml EDTA (pink top)     N/A
Direct Antiglobulin Test        6 ml EDTA (pink top)     1.5 ml EDTA (purple top)
(DAT)
Kleihauer                       6 ml EDTA (pink top)     N/A
Cord Blood Group and DAT        6 ml EDTA (pink top)     N/A

        Send out test                  Samples
Platelet Antibodies             Only to be ordered following discussion with the
Other Platelet investigations   Blood Bank. They will then advice on samples
HLA Antibodies                  required.
HLA Typing

4.1 Sample Processing
    4.1.1 Group and Save
    • To determine ABO / Rh D type, and whether red cell antibodies are present.
    • Currently the samples are routinely “batch tested”. Results are available either same
        or next routine working day.
    • Group and Save samples are held for 14 days and are available for crossmatching
        on patients who have not been recently transfused.
            o If the patient was transfused within the last 2 – 14 days the sample must be
                taken within 24 hours before transfusion.
            o If the patient was transfused within the last 15 – 28 days the sample must be
                taken within 72 hours before transfusion.
            o If the patient is pregnant the sample should be taken within 72 hours before
                transfusion.

    4.1.2 Red Cell Compatibility Testing (Cross Matching)
    • Takes 40 minutes in patients without antibodies
    • Patients with antibodies may take much longer. Contact blood bank laboratory.
    4.1.3 Issue of Immediate Un-cross matched blood:
    • This blood is group specific - only for urgent situations.
    • Takes 10 minutes from the sample arriving in the laboratory.

5.0 Stocks held by the Blood Transfusion Laboratory

5.1 Emergency Issue O Negative blood (flying squad blood)
There are two units of group O Rh CDE neg, K neg blood kept in the blood bank. This is for
use in extreme emergencies only and is accessed via a member of blood bank staff.

5.2 Red Cells
    Approximate stock levels held are:
                                         Positive      Negative
                      Group O              30            12
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                      Group A            30                 15
                      Group B            12                  2
                     Group AB            2                   2
   2 paediatric packs are kept on site

5.3 Fresh Frozen Plasma/Cryoprecipitate
    • Approximately 60 units of fresh frozen plasma and 50 units of cryoprecipitate are
        stored on site. This includes some methylene blue treated FFP for neonatal and
        paediatric use.
5.4 Platelets
    • Platelets are not stored on site, but are ordered on a daily basis from NBS Tooting.
    • Tell the blood bank before 10.30 hr for platelets required p.m. delivery.
    • Tell the blood bank before 16.30 hr for platelets required next a.m.
    •
5.5 Products with Special Requirements – (Irradiated, CMV Neg, Genotyped)
    • These are obtained via the NBS, Tooting. See above paragraph.

5.6 Other blood products
    Items held in the blood bank laboratory.
    • Anti D 250 and 500 IU
    • Blood bags for venesection / normovolaemic haemodilution

The following may be ordered through the blood bank from St Thomas’ Hospital if
sanctioned by Haematology Consultant.

   Factor VIII concentrate
   Beriplex (prothrombin complex concentrate)
   Recombinant Factor VIIa
   Anti D 2500 iu (IV administration)

6.0 Giving Sets
        Blood / blood product.                            Type of giving set
Red cells in additive solution                Dedicated blood administration set with
                                              an inbuilt 170-200 micron filter.
                                              Or
                                              IVAC pump blood giving set.
Fresh Frozen Plasma                           Blood administration set.
Cryoprecipitate                               Blood administration set.
Human Albumin Solution                        Standard intravenous infusion giving set.
Platelets                                     Platelet Administration Set. This will be
                                              issued by blood bank with the platelets.
Factor Concentrates (e.g. VIII or IX)         Slow bolus injection from a syringe at a
                                              rate of1ml/minute
Warmed blood                                  Blood warmer with blood warmer coil /
                                              dedicated giving set appropriate to
                                              warmer




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                  Transfusion Policy
                     Appendix 2
              Roles and Responsibilities



                     Date: November 2005

                     Ref : PCD 032 - A2

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD032-A2
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




                               Transfusion Policy
                                  Appendix 2
                           Roles and Responsibilities

Content

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1.0    Introduction
2.0    Aims and objectives
3.0    Scope
4.0    Defining responsibilities
4.1    Managers and Consultants.
4.2    Consultant staff
4.3    Medical Officers, (doctors registered with the General Medical Council).
4.4    Medical staff
4.5    Senior nurses and midwives (with whom a policy has been agreed):
4.6    Supplementary Nurse Prescribers.
4.7    Registered nurses and midwives:
4.8    Health Care Assistants:
4.9    Operating Department Practitioners:
4.10   Phlebotomists
4.11   Porters, theatre support workers and trained staff:
4.12   State Registered Biomedical Scientists (BMS) and supervised trainees:
4.13   Medical Laboratory Assistants (MLA)
4.14   Hospital Transfusion Committee:
4.15   The Hospital Transfusion Team:
4.16   The Clinical Governance Board on behalf of the Trust Board
4.17   Head of Estates and Facilities (Carillion):
4.18   All Staff

5.0    Table - Blood Transfusion - a multi-discipline process




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                                    Transfusion Policy
                                       Appendix 2
                                Roles and Responsibilities

1.0 Introduction
As with most processes within the health service, good transfusion practice requires a multi-
professional approach.

2.0 Aims and objectives
To define the roles and accountabilities of staff involved in the process of blood transfusion

3.0 Scope
All involved in the transfusion process. See below.

4.0 Defining responsibilities

4.1 Managers and Consultants.
Are responsible for:
    • Implementation of the blood transfusion policy.
    • Monitoring standards of care.
    • Training and training records.
    • Facilitating incident reporting including SHOT and MHRA.
    • Providing patient literature.

4.2 Consultant staff
Are responsible for:
    • Maintaining an up to date Maximum Blood Order Schedule
    • Promoting appropriate use of blood and alternatives to transfusion.

4.3 Medical Officers, (doctors registered with the General Medical Council).
Are responsible for:
    • Assessing the patient’s blood product requirement.
    • Prescribing and ordering blood products stating, component, quantity, duration of
       transfusion and any special requirements (e.g. irradiated products, CMV negative).
    • Communicating and discussing decisions with nurses.
    • Explaining risks and benefits of transfusion to patients.
    • Obtaining patient consent for transfusion.
    • Documenting the reason for transfusion and the clinical outcome in the medical
       notes.
    • Knowing how to investigate and manage transfusion reactions.

4.4 Medical staff
 Share responsibility for:
    • Requesting blood products including special requirements i.e.: CMV Negative or
       Irradiated.
    • Taking and submitting samples for compatibility testing.
    • Dealing with and reporting transfusion reactions and transfusion incidents.
    • Prompt return of unused components within agreed time frame.
    • Cannulating patients.
    • Intravenous drug management and use of specialist lines.
    • Requesting blood for cross match.
    • Prescribing blood for transfusion.
    • Accurate documentation.
    • Collection and removal of blood from blood fridge.
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   •   Returning of blood to blood bank fridge.
   •   Obtaining emergency blood supply.
   •   Correct patient identification.
   •   Providing patient information.
   •   Administering blood.
   •   Checking blood and blood product
   •   Managing adverse events

4.5 Senior nurses and midwives (with whom a policy has been agreed):
Blood, including red cells and platelets, is now considered to be a medicinal product and
cannot be prescribed by nurses unless agreed by local Trust policy. Those approved may
request blood products, including special requirements i.e.: CMV Negative or Irradiated.
Those approved must:
    • Take samples of blood for cross match
    • Cannulate patients
    • Be responsible for Intravenous drug management and use of specialist lines
    • Monitor and observe patient observations
    • Provide documentation, ensuring accuracy.
    • Collect and remove blood from blood fridge
    • Return blood to Blood Bank/fridge
    • Obtain emergency blood supply
    • Identify patient correctly
    • Gain patient’s consent
    • Provide patient information
    • Administer blood
    • Check blood/blood product
    • Manage adverse event

4.6 Supplementary Nurse Prescribers.
Products derived from plasma (e.g. anti-D) are considered medicinal products and may be
prescribed by registered nurses who have undertaken the appropriate prescribers course
provided they are included in the necessary Clinical Management Plan (DoH 2004). These
registered nurse prescribers must have obtained documented agreement from their
Professional Head of Nursing/Midwifery and Clinical Director.

4.7 Registered nurses and midwives:
Are responsible for;
    • The positive identification of the patient when taking samples and administering
       blood products.
    • Confirmation that consent has been obtained.
    • Explaining the risks and benefits of blood transfusion to patients.
    • Accurate checking, administering and discard of blood components.
    • Accurate observation of patient during transfusion.
    • Monitoring patient transfusions and management of adverse incidents.
    • Reporting incidents relating to the transfusion (including transfusion reactions).
    • Prompt return of unused components within agreed time frame.
    • Taking blood samples for compatibility testing in compliance with the “Guidelines for
       Requesting Blood Transfusion and the Collection of Blood Samples for Pre-
       transfusion Compatibility Testing”.

4.8 Health Care Assistants:
May be responsible for;
    • Correct identification of patient and blood products.
    • Collection, Identification of blood products for a named patient.
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   •   Transport and delivery of blood products to appropriate clinical areas.
   •   Accurate observation and monitoring of the patient during transfusion.
   •   Help in dealing with Transfusion Reaction.
   •   Reporting incidents relating to the transfusion (including transfusion reactions).
   •   Prompt return of unused components within agreed time frame.
   •   Safe Disposal of waste.

4.9 Operating Department Practitioners:
May be responsible for;
    • Correct identification of patient and blood products.
    • Collection, Identification of blood products for a named patient.
    • Transport and delivery of blood products to appropriate clinical areas.
    • Accurate observation of patient during transfusion.
    • Prompt return of unused components within agreed time frame.
    • Administering blood products.
    • Monitoring patient transfusions and managing adverse incidents.
    • Reporting incidents relating to the transfusion (including transfusion reactions).
    • Taking samples of blood for cross-match
    • Cannulating patients
    • Intravenous drug management and use of specialist lines
    • Accurate documentation
    • Obtaining emergency blood supply

4.10 Phlebotomists
Are responsible for;
   • Checking the identity of a patient before taking any blood test.
   • Checking that information on the request is correct and complete.
   • Taking and labelling blood samples for compatibility testing in accordance with the
       local Standard Operating Procedures.
   • Reporting incidents.

4.11 Porters, Theatre Support workers and trained staff:
May be responsible for;
   • Collection, Identification of blood products for a named patient.
   • Prompt transport and delivery of blood products to appropriate clinical areas.
   • Prompt return of unused components within agreed time frame.
   • Obtaining emergency blood supply
   • Identifying patient information correctly

4.12 State Registered Biomedical Scientists (BMS) and supervised trainees:
Are responsible for;
   • Ordering and storage of blood products.
   • Correct identification of samples against requests.
   • Checking patients for special blood requirements.
   • Accurate and timely testing.
   • Ensuring compatibility of issued components.
   • Ensuring integrity of the blood products.
   • Providing correctly labelled blood products which correlate with the details on the
       sample that was used for the testing purposes.
   • Maintaining records of blood product usage to facilitate audit trails, patient
       transfusion records and provide statistical information.
   • Investigation and reporting of transfusion incidents
   • Receipt of samples and arrangement of appropriate laboratory tests

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   •   Issuing blood products
   •   Managing blood stocks and minimise wastage.
   •   Offering advice and support to clinical staff
   •   Identifying patient information correctly
   •   Accurate documentation

   •   All procedures will be in compliance with approved laboratory Standard Operating
       Procedures (S.O.Ps)

4.13 Medical Laboratory Assistants (MLA)
Are responsible for;
   • Receipt and labelling of samples in accordance with S.O.P.s
   • Data entry and/or filing of patient and blood product information.

4.14 Hospital Transfusion Committee:
Is responsible for
     • Review Blood of Transfusion Policies and Procedures.
     • Review of adverse transfusion events including "near misses".
     • Recommendation of corrective action in transfusion practice where indicated and
        feedback to clinical areas.
     • Monitoring staff training in relation to transfusion.
     • Review of the appropriate use of blood products.
     • Promotion of continuing education for all relevant members of staff.
     • Review of transfusion documentation/policies
     • Ensuring participation in audit

4.15 The Hospital Transfusion Team:
   • Assists in the Implementation of The Hospital Transfusion Committee’s Objectives.
   • Reviews/implements Blood Transfusion Policies and Procedures.
   • Actively promotes the Implementation of Good Transfusion Practice.
   • Provides advice and Support to Clinical teams on the Appropriate and Safe Use of
       Blood.
   • Audits the transfusion process to ensure best practice.
   • Reviews adverse events including "near misses" and report to SHOT/MHRA.
   • Provides and/or monitor staff training in relation to transfusion.
   • Participates in the Activities of the Regional Transfusion Committee

4.15.1 The HTT comprises:

Clinical Lead in Transfusion
This is a Consultant Haematologist whose role is to support best practice, disseminate
guidance from the Department of Health, National Blood Service and the British Committee
for Standards in Haematology (BCSH) and their published guidelines.

Senior Chief Biomedical Scientist in Transfusion:
Has expertise in Transfusion Laboratory Medicine, and whose role is to promote best
techniques and appropriate usage of blood and blood products.

Specialist Practitioner of Transfusion (SPoT):
A senior healthcare professional, whose role is to promote and implement best practice in
transfusion medicine. The SPoT will be involved in multidisciplinary education and training
and also auditing to ensure good clinical practice and adherence to national guidelines
throughout the Trust.


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4.16 The Clinical Governance Board on behalf of the Trust Board
Is responsible for:
    • Reviewing minutes of the H.T.C. meeting.
    • Ensuring that Blood Transfusion local policies are in place.
    • Ensuring a system exists for the initial training of all relevant staff to blood transfusion
       policies.
    • Ensuring a system exists for annual updating of all relevant staff to blood transfusion
       policies.
    • Informing and ensuring compliance of all relevant healthcare professionals with
       Hospital Transfusion Committee Guidelines via the clinical governance agenda.

4.17 Head of Estates and Facilities (Carillion):
Responsible for ensuring porters follow the Trust transfusion procedures e.g. delivering
samples, collecting blood products etc.

Also to ensure appropriate maintenance and servicing of equipment and environment
required for the safe storage and provision of blood products. Etc.

4.18 All Staff
Are responsible for checking that their activity complies with the guidance in this protocol.




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                           Blood Transfusion – A Multidisciplinary Process
             Assess patient’s clinical need for transfusion                        Doctor/Nurse
                                      ↓
             Discuss the need for transfusion with patient
                                 ↓
      Record indication for transfusion in the patient’s records                       Doctor
                                 ↓
                Complete and sign blood request form                           Doctor / Senior Nurse
                                  ↓
            Take blood sample for pre-transfusion testing             Doctor/ Nurse / HCA / Phlebotomist / ODA

                                      ↓
      Send sample + request form DIRECTLY to Blood Bank               Doctor / Nurse / HCA Phlebotomist /ODA /
                                                                                       Air-tube
                                      ↓
      Perform pre-transfusion screening and compatibility tests
                                 ↓
                                                                                Biomedical Scientist
                        Select compatible units
                                                                                     (BMS)
                                  ↓
          Generate compatibility form and blood bag labels
                                  ↓

             Release components to Blood Bank Fridge
                                      ↓
                  Collect blood or blood components                         Porter / HCA / Nurse / Doctor
                           From Blood Bank                                       ODA / Ward Clerk
                                      ↓
         Receive blood or blood components in clinical area                    Nurse / Doctor / ODA
                                  ↓
                Prescribe blood or blood components                                    Doctor
                                    ↓
Perform and record identity checks prior to administration
                                                                                   Doctor / Nurse
                                      ↓
           Undertake and record baseline observations
                                  ↓
                        Administer transfusion
                                  ↓
      Monitor patient’s temperature and pulse 15 minutes after
                       transfusion commenced
                                 ↓
           Continuing observation of patient as appropriate
                                 ↓
                 Respond to any adverse event
                                ↓
       Record completed transfusion and post-tx observations
                                ↓
 Record post-transfusion laboratory results and clinical outcome in
                          patient records




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                        Transfusion Policy
                           Appendix 3
                     Information for Patients
                        and their Relatives


                     Date: November 2005

                     Ref : PCD 032 – A3

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD032-A3
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 30 of 225
Transfusion Policy                                           November 2005
Ref: PCD 032(v1)                                         Status : Operational
                                 Transfusion Policy
                                     Appendix 3
                     Information for Patients and Their Relatives


Contents

1.0    Introduction
2.0    Aims and Objective.
3.0    Scope
4.0    Source of information
4.1    Leaflets for Adults
4.1    Leaflets for Children
5.0    Record that information has been given.
6.0    Answers To Questions Patients May Ask.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 31 of 225
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                                 Transfusion Policy
                                     Appendix 3
                     Information for Patients and Their Relatives

1.0 Introduction
It is advised that all patients who are to undergo transfusion make an informed choice about
their treatment. In addition those having a transfusion are more likely to recognise the signs
and symptoms of an adverse reaction if they have knowledge of these before hand.

2.0 Aims and Objective.
To give patients relevant information related to their care.

3.0 Scope
All those involved in the transfusion process, especially those with direct patient contact.

4.0 Source of information
All patients who are reasonably likely to receive transfusion support during their treatment
episode should receive the NHS information leaflet, “Receiving a blood transfusion”,
informing them of the risks and benefits of this therapy, and the local availability of
alternatives to donor blood. The leaflet is available on all wards, outpatient department and
the patient information desk. Replacement supplies are kept in the transfusion department.

An electronic version of the leaflet is available for download in: English, Urdu, Punjabi,
Gujarati, Turkish, Greek, Chinese, Polish, Vietnamese, Welsh, and English

http://www.blood.co.uk/hospitals/library/pi/index.htm.


4.1 Leaflets for Adults




4.2 Leaflets for Children
Specially designed information packs for children are also available. There is a copy on
Willow ward. This should first be given to the parent / guardian, who will decide whether it is
suitable for their child. Replacement copies are available from the transfusion department.




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Ref: PCD 032(v1)                                                    Status : Operational
5.0 Record that information has been given.
It is the responsibility of the medical staff to ensure that patients (or their relatives) have read
and understood the content of the leaflet when they are consented for a surgical procedure,
likely to require transfusion or are embarking upon their first transfusion episode for
haemato-oncology support or for other medical reasons.

The patient’s receipt and understanding of the information should be recorded in the case-
notes.

Jehovah’s witnesses have traditionally been bound by their church’s official policy to refuse
blood transfusion support. This group of patients should be counselled, consented and
managed in accordance with the Trust procedures. See Transfusion Policy Appendix 5 (PCD
032-A5) - Clinical Management of Patients who Refuse Blood.

6.0 Answers To Questions Patients May Ask.
Why Might I Need A Blood Transfusion?

Blood transfusions may be given to replace blood that has been lost because of injury,
surgery, abnormal bleeding or for some types of anaemia. Red cells carry oxygen, which is
needed to release energy from food and is essential for normal living. Anaemia is the name
given to the condition where there are reduced numbers of red cells.

There are many reasons for anaemia - the most common being a lack of iron - iron
deficiency anaemia. This is usually caused by blood loss from somewhere in the body over a
period of time. Many types of anaemia can be treated by tablets e.g. iron pills or vitamins,
and the blood will return to normal in the course of a few weeks.

In certain circumstances, however, a large amount of blood may be lost quickly as in an
accident or major operation, or the bone marrow is not able to make red cells as effectively
as normal. In these conditions it can be essential to replace the red cells rapidly by a blood
transfusion to ensure a good recovery, and in some instances this is a life-saving treatment.

Your doctor will only recommend a transfusion if you really need it and there is no better
alternative.

Is Blood Safe?
All blood donors in the UK are unpaid volunteers, who are carefully questioned about their
health. Before they donate blood, every effort is made to identify and exclude those donors
who may be at risk of passing on infections.

Every unit of donated blood is then individually tested. Any blood, which fails these rigorous
tests, is discarded. It is now rare for viruses HIV, Hepatitis B and C, to be passed on in
blood. It is thought that there is a theoretical risk that new variant Creutzfeldt-Jakob Disease
(vCJD) may be transmitted via blood, and in particular via the white cells in blood. So since
1999, all donated blood has been passed through a filter to remove the white cells. This
process is called leucodepletion.

Nevertheless, there are risks associated with having a blood transfusion, and you must feel
confident that these have been balanced against the risks to your health of not having a
transfusion, before consenting to this treatment.

Can I Have a Reaction to Someone Else’s Blood?
There are many different blood groups, which differ from person to person. Before a blood
transfusion is given, a blood sample will be taken from you, with your verbal consent, to find
out your blood group, and to match your blood with that of suitable blood donors. This and
other tests are done to reduce the chances of you experiencing any reaction. Sometimes
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however patients do react to a transfusion and most commonly this takes the form of a fever
or chills.

If you feel unwell in any way during a transfusion, you must alert your nurse immediately.
Having a reaction does not mean that the blood is infected. It usually indicates that your
body can recognise that the transfused blood is not your own. Often all that is required is to
slow down the speed of the transfusion a little and your symptoms will disappear.

When selecting blood for transfusion, it is not possible to match a donor’s cells exactly with
those of the patient, as there are many different blood groups. Therefore only the two most
important blood groups are tested for and matched. These are the ABO and Rh D blood
groups.

After a transfusion, about 2% of people may develop antibodies to minor blood groups that
were present in the donated blood. These antibodies will not usually make a person feel ill in
any way, but will be identified if blood tests are done in the future. These tests will help to
decide what sort of blood should be given for a future transfusion. This explains why your
blood must be re-tested before every transfusion that you receive.

Are There Other Important Side Effects To Be Aware Of?
During a blood transfusion you will always be checked and observed by a qualified nurse
who will identify any unexpected development. The extra volume of fluid going into your
blood stream can put a temporary strain on your circulation. This is more common if you are
having a large transfusion over a short time. It may also occur if you have other conditions
that affect your heart and lungs. To counteract this effect, a diuretic (water tablet) is often
given that will make you pass more urine.


Some patients, particularly those who have diseases affecting the bone marrow production
of blood, require regular transfusions over many years. This may lead to excessive amounts
of iron accumulating within the body, which may slowly cause damage to important organs
such as the heart, liver or lungs. Although at present there is no easy or reliable way to
prevent this, it does not usually start to become a problem until a person has received more
than one to two hundred units of blood.

Do I Have To Sign A Consent Form?
Written consent is not necessary in order to receive a blood transfusion. However it is very
important that your blood transfusion is only started with your full agreement. You should feel
comfortable that you have received sufficient information to allow you to make an informed
decision.

If you are to undergo surgery, the need for transfusion will be discussed with you when you
agree to consent to the operation. It is occasionally necessary to have a transfusion
afterwards, and this will also be discussed with you and whether alternative treatments such
as iron tablets would be effective.

If you require additional information or more time for discussion, you should make this clear
to the nurse/midwife before she starts the transfusion. If you decide that you do not wish to
proceed, you must tell the nurse/midwife immediately and your transfusion will be cancelled.

What If I Have Other Concerns?
You may be worried about such things as feeling squeamish at the sight of blood or of
having a needle put into your arm. The doctor or nurse can help with these problems. Please
tell them about your concerns even if you think they may be silly or of no importance.


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Hospital Transfusion Committee                             Page 34 of 225
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Ref: PCD 032(v1)                                                  Status : Operational
When you are receiving a blood transfusion, ask your nurse to explain anything about the
procedure that you do not understand. If at any time you fell unwell or suspect that you are
reacting to the blood transfusion, call for help immediately. Do not worry about making a fuss
- it is better for staff to be called and be able to reassure you than miss an opportunity to nip
a problem in the bud.


If you need further information, or if anything is unclear, please ask the doctors or nurses
looking after you. For elective operations, please discuss any further concerns with the pre-
assessment clinic doctor, nurse or midwife.

If you require an interpreter please let us know.




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Hospital Transfusion Committee                             Page 35 of 225
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Ref: PCD 032(v1)                                       Status : Operational




                       Transfusion Policy
                          Appendix 4
                     Consent to Transfusion

                     Date: November 2005

                     Ref : PCD 032 – A4

                     Vers : 1

      Policy Profile
      Policy Reference Number     PCD 032-A4
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 36 of 225
Transfusion Policy                                          November 2005
Ref: PCD 032(v1)                                        Status : Operational
                                 Transfusion Policy
                                    Appendix 4
                               Consent to Transfusion


Contents


1.0      Introduction
2.0     Aims and Objectives
3.0     Scope
4.0     Who consents?
5.0     Procedure
5.1     Mental Disorder
5.2     Children
5.2.1   Over 16 years
5.2.2   Under 16 years
5.3     Emergencies
5.4     Patients who refuse transfusion
5.4.1   Management of patients who refuse blood
5.4.2   The unborn child.




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Hospital Transfusion Committee                             Page 37 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
                                   Transfusion Policy
                                      Appendix 4
                                 Consent to Transfusion

1.0 Introduction
The Patient’s Charter states that patients have a right to know, where possible, about the
treatment they are being offered. This will include the aims, benefits, risk and discomforts of
the proposed treatment and the alternatives available.

2.0 Aims and Objectives
Patients at Darent Valley Hospital are given the opportunity to make an informed choice
about their treatment.

3.0 Scope
For those prescribing and administering transfusion of blood products and those involved in
patient assessment e.g. for surgery, pregnancy.

4.0 Who consents?
Discussion about the need for transfusion and obtaining consent is the responsibility of the
doctor prescribing the blood or blood product, and should be documented in the patient’s
notes. In addition the practitioner administering the unit should also obtain verbal
confirmation from the patient that he or she consents to receiving blood before
commencement of the transfusion.

Where agreed, consent may be taken by appropriately trained specialist nurses and
midwives (e.g. for anti D immunoglobulin).

Consent must include the following elements:-
• That the patient has the capacity to understand.
• That the patient has been given adequate information.
• That the patient is not coerced.

Where the patient is too young to give consent this should be explained to an adult with
parental responsibility.

5.0 Procedure
Formal written consent is not required. Verbal informed consent is sufficient.

Transfusion should be discussed as one would discuss the need for a particular drug. The
discussion should be with the patient or his or her guardian, where appropriate.

Document in the case notes, that the patient has been given information, had any questions
answered and consented to receive blood products. This may be important in a medico-legal
case.

Appendix 3     Information for patients and their relatives.
Appendix15     Autologous Blood Transfusion.
Appendix 5     Management of Jehovah’s Witnesses and others who refuse blood
               Transfusion.

5.1 Mental Disorder
The presence of a mental disorder does not by itself imply incapacity, nor does detention
under the Mental Health Act.



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Hospital Transfusion Committee                             Page 38 of 225
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Ref: PCD 032(v1)                                                  Status : Operational
Each patient’s capacity for giving consent has to be judged individually in the light of the
nature of the decision required and the mental state of the patient at the time.

Where practitioners are asked to provide medical treatment to mentally disordered patients’
then this should be fully discussed with the patient’s medical team.

In the case where mentally disordered patients refuse a transfusion, advice should be
sought form the on-call duty psychiatrist.

5.2 Children (Also see Appendix 26 Neonatal Transfusion Policy)

5.2.1 Over 16 years
Young people over 16 are able to consent to or refuse treatment.

Where those over the age of 16 are not competent to give valid informed consent, then the
consent of the parent or guardian must be sought. However this only extends until the child
is 18.

5.2.2 Under 16 years
Children under the age of 16, who can demonstrate sufficient understanding of what is
proposed, may give informed consent. Parents cannot veto the consent or otherwise of a
child. Parental consent should be obtained where the child does not have sufficient
understanding and is under the age of 16 except in an emergency where there is no time to
obtain it.

In an emergency situation where parents could have a specific religious beliefs that could
prevent them consenting to blood transfusion for their child, a doctor can decide to provide a
treatment, including blood transfusion, in the child’s best interest.

In the case of a planned blood transfusion it would be appropriate to seek a ruling from a
court of law. In these circumstances it is recommended that the doctor’s medical defence
body is consulted for advice on how to proceed. The Trust Medical Director, nominated
deputy or another Executive Director should be notified.

5.3 Emergencies
During emergencies, if the patient is unconscious and incapable of making this decision, it is
permissible to transfuse blood to save life, provided there is no written evidence to the
contrary, that is on the person or immediately available.

Transfusion cannot be prohibited by relatives purporting to express what might be the
patient’s views. The doctor must at all times act in the patient’s best interest.

5.4 Patients who refuse transfusion
Patients have the right to refuse transfusion.

In this case the doctor must explain to the patient the nature of his or her illness and the
need for the proposed transfusion and of the possible consequences if the blood is not
given.


Doctors should discuss the alternatives available.

The Trusts Surgery Consent Form excluding Blood Transfusion has a tick box for
transfusion.


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Hospital Transfusion Committee                             Page 39 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
In other circumstances a refusal to treatment form must be completed, signed and
witnessed.

If the patient has an advanced directive that specifies refusal of blood components, this must
be honoured.

5.4.1 Management of patients who refuse blood

See Appendix 5

5.4.2 The unborn child
Women who are pregnant, and by refusing blood affect their unborn child present a special
problem. A court may only order in these circumstances if it is satisfied that the mother lacks
the capacity to accept or refuse the medical treatment proposed. An assessment by an
independent psychiatrist will be necessary if the patient’s capacity is in doubt.

Please remember to document all consent decisions
Please remember, people are allowed to change their mind.




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Hospital Transfusion Committee                             Page 40 of 225
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Ref: PCD 032(v1)                                       Status : Operational




         Transfusion Policy
             Appendix 5
Guidelines on the Clinical Management
Jehovah’s Witness Patients and Others
   Who Refuse Blood Transfusion.

                     Date: November 2005

                     Ref :   PCD 032 – A5

                     Vers : 0

      Policy Profile
      Policy Reference Number
      Version                     0
      Status                      Draft
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 41 of 225
Transfusion Policy                                                November 2005
Ref: PCD 032(v1)                                              Status : Operational
                              Transfusion Policy
                                 Appendix 5
Guidelines on the Clinical Management Jehovah’s Witness Patients and Others
                        Who Refuse Blood Transfusion

Contents



1.0    Introduction
2.0    Scope
3.0    Related Trust Policies
4.0    Jehovah’s Witnesses
4.1    Background.
4.2    Ethical conflict
4.3    Acceptability of blood products.
4.4    Auto transfusion / haemodilution
5.0    Elective Surgery.
5.1    Considerations prior to surgery
5.2    Elective Surgery With Risk Of Significant Bleeding
5.3    Pre-Surgical Meeting - format
5.4    Pre-Operative Clinical Assessment
5.5    Standard doses for pre-operative treatment to correct abnormalities
6.0    Peri-Operative Management
6.1    Pre-deposit Transfusion
6.2    Disorders of coagulation
6.3    Reduction of intra-operative blood loss.
6.4    Other measures to reduce the need for blood transfusion during surgery.
7.0    Legal Issues
7.1    Agreement to treat
7.2    Elective Surgery Adults
7.3    Elective surgery Children.
8.0    Emergency Admissions
8.1    Conscious adult Jehovah’s Witness patients.
8.2    Unconscious adult Jehovah’s Witness patients.
8.3    Paediatric Jehovah’s Witness patients.
9.0    Patients suffering from a mental disorder
10.0   Foetal vs Maternal Rights.
11.0   Women in Labour, refusing transfusion.
11.1   Risk factors predisposing to postpartum haemorrhage
11.2   Actively haemorrhaging patient
12.0   References And Sources Of Further Information

Appendix 1   Emergency Adult Flow Chart
Appendix 2   Paediatric Emergency and Elective Flow Chart
Appendix 3   .Adult Elective Surgery Flow-Chart (Significant Risk of Bleeding)
Appendix 4   Adult Elective Surgery Flow-Chart (Minimum Risk of Bleeding
Appendix 5   Contacts
   Appendix 6        Form - For the use by Jehovah’s Witness: to exclude the use of blood
      transfusion or blood components.




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Hospital Transfusion Committee                             Page 42 of 225
Transfusion Policy                                                     November 2005
Ref: PCD 032(v1)                                                   Status : Operational
                              Transfusion Policy
                                 Appendix 5
Guidelines on the Clinical Management Jehovah’s Witness Patients and Others
                        Who Refuse Blood Transfusion


1.0 Introduction
The policy relates mainly to Jehovah’s Witnesses (JWs), however there are a growing
number of patients who, for a variety of reasons, will be resistant to transfusion. For these
patients, fears are often unfounded.

   The risks and advantages of transfusion should be discussed sensibly and
      sympathetically with the patient.

The Trust will ensure that Jehovah’s Witnesses beliefs are acknowledged and respected and
that that information is provided for the management of these patients.

2.0 Scope
This information is for all involved in the transfusion process, but is of particular relevance to
the Surgical, Anaesthetic and Haematology Departments.

3.0 RELATED TUST POLICIES
This should be read in conjunction with Trust Policies on Adagio
    • Policy 480 Jehovah’s Witnesses (JWs)
    • Policy 22 Obstetric Haemorrhage

4.0 JEHOVAH’S WITNESS
4.1 Background
Jehovah’s Witnesses are a fundamentalist Christian sect. Approximately 150,000 live in the
UK.

They refuse blood transfusions as they feel it violates God’s law based on a literal reading of
a number of biblical passages. Receiving blood means eternal spiritual damnation and a
Jehovah’s Witness (JW) who agrees to receive blood will revoke his/her own membership of
the movement.

The use of whole blood is generally refused. However there are no specific rules regarding
the derivatives or fractions of any of the primary components. Each JW must
“conscientiously decide for himself” (Watchtower, June 2000). Table 1 summarises what is
acceptable for transfusion. However experience shows that many refuse derivatives too.

4.2 Ethical Conflict
Jehovah’s Witnesses can cause ethical conflict, as physicians have pledged to preserve and
prolong life to the best of their ability and judgement. An anaesthetist or surgeon in an
elective situation has the right to refuse to manage these patients if they feel unable to
comply with a no blood policy. They should refer them to a suitable and agreeable colleague.
In an emergency situation, however, the doctor is obliged to provide care and must respect
the patient’s competently expressed views.
The Jehovah’s Witnesses have set up a number of Hospital Liaison Committees with
representatives who are available to advise or assist in individual cases. See Appendix 5
below a list of local JW contacts.




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Ref: PCD 032(v1)                                                    Status : Operational
4.3 Acceptability of blood products:

                                       May or may not be
        Not acceptable                     acceptable                       Acceptable
                                    (‘Matter of conscience’)

Primary components of blood         Derivatives of the primary    Crystalloids
• Whole blood                       blood components               Synthetic colloids
• Red cells                         • Albumin                     • Dextrans,
• Platelets                         • Immunoglobulin
• White cells                       • Vaccines                    • Hydroxyethylstarch
• Plasma (FFP)                      • Coagulation factors (non     (Hetastarch)
  (cryoprecipitate)                     recombinant)
                                                                  • Gelatins
This includes blood and             Haemodilution                  (haemaccel)
components from pre-deposit         Intraoperative cell
autologous donations.               salvage                        Recombinant products eg
                                    Post operative cell            FVIIa
                                    salvage                        (EPO, coagulation factors)
                                    Organ transplantation

4.4 Auto Transfusion / Haemodilution
Immediate intra-operative auto transfusion (cell salvage) is permitted by many witnesses
provided the circuit is linked to the patient’s circulatory system and there is no storage.

Intra-operative haemodilution is permitted by many witnesses when the equipment is
arranged so as to keep the blood in a constant link to the patient’s circulatory system.
However, pre-operative collection and subsequent re-infusion is not permitted.

5.0 ELECTIVE SURGERY
5.1 Considerations prior to surgery:
    • Careful advance planning is required.
    • Explain risk of bleeding to the patient and the possible consequence of refusing
      blood.
    • Each patient should (unless they decline the offer) be asked about his or her own
      personal interpretation in a one-to-one discussion and this documented in the
      patients notes.
    • Determine what blood products / blood salvaging techniques the patient is willing to
      accept.
    • Good communication is essential between surgeon, anaesthetist and haematologist.
    • Senior medical and nursing staff must be involved.
    • The patient must sign a special consent form, which includes the refusal of blood and
      blood products and absolves the physician from any associated liability. This should
      be witnessed. This document is then legally binding and as such must be
      documented in the notes.
    • If patient bleeds whilst anaesthetised blood must not be given and the reasons why
      documented in the notes.

5.2 Elective Surgery with Risk of Significant Bleeding
If elective surgery is associated with a risk of significant bleeding i.e. the patient would
normally be routinely group and saved, special consideration should be taken.

A planning team should meet with the patient at least 4-6 weeks prior to surgery.
The team should consist of:
    • Consultant surgeon
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Hospital Transfusion Committee                             Page 44 of 225
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Ref: PCD 032(v1)                                                   Status : Operational
   •   Consultant anaesthetist
   •   Consultant haematologist
   •   Blood Transfusion Practitioner

Prior to this meeting, full preoperative investigations should be carried out, including
FBC, coagulation and haematinics, and the results made available to all parties.

5.3 Pre Surgical Meeting - Format
While flexible, it should contain the following:

   •   The patient is assured that the intention of the meeting is to formulate a plan for
       surgery that complies with his/her wishes and beliefs, and that no attempt will be
       made to frighten them or place him/her under any duress. The patient should also be
       asked has they have consulted the written advice of the Jehovah’s Witness
       Transfusion Committee (JWTC) on permissible products for infusion and whether
       his/her views differ from the view of the JWTC in any respect.

   •   The surgeon outlines the proposed operation, describes possible complications that
       may result in bleeding, and reminds the patient of the ever-present risk of bleeding
       with any surgery. This description and its understanding by the patient are both
       documented*.

   •   The anaesthetist outlines techniques used to avoid transfusion of blood. The patient’s
       informed consent to these measures is obtained and documented*. The anaesthetist
       asks what is and is not sanctioned by the patient should he/she become unconscious
       or otherwise unable to communicate and is dying of unexpected blood loss. This is
       also documented*.

   •   The haematologist asks the JW patient which therapeutic agents are regarded as
       acceptable to infuse to support volume and/or haemostatic function in the event of
       bleeding. The written or spoken advice of the JW Transfusion Committee to the
       patient may be required. The result of this enquiry is documented*.

   •   The haematologist explains the technique of preoperative haemoglobin enhancement
       using recombinant erythropoietin (EPO), and if the patient accepts this therapy,
       clinical assessment and EPO therapy if appropriate is arranged. (Daily EPO, 300u/kg
       from 10 days preoperatively to 5 days postoperatively or 600u/kg weekly for 3 weeks
       before surgery and on the day of surgery).

   •   At the end of the discussion the JW patient and his/her supporter(s) should be asked
       if there are any further questions or concerns. The clinical team then agree (or
       disagree) with the patient to go forward with the operation on the terms above and
       this commitment is documented.

Should it not be possible for all 3 Consultant Specialists to meet together, it is imperative that
everyone is still informed 6 weeks prior to surgery so there is adequate time for appropriate
patient preparation.

5.4 Pre-Operative Clinical Assessment.
Prior to surgery the following clinical issues must be considered.

   •   Optimise cardiovascular and respiratory disease.
   •   Preoperative investigations should include FBC, Clotting screen, U+E and LFTs.
   •   Investigate anaemia and treat with iron, folate or vitamin B12 if appropriate
   •   Stop NSAIDs and aspirin 2 weeks prior to surgery.
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   •   Convert patients on warfarin to heparin or stop anticoagulant if appropriate.
   •   Consider use of erythropoietin to raise preoperative haemoglobin (2-3 weeks
       required to achieve a significant increase in red cell volume).

5.5 Standard doses for pre-operative treatment to correct abnormalities
Standard doses:

Ferrous sulphate       200mg oral x 2/day
Folic Acid             5mg oral x 1/day
Vitamin B12            1mg i.m. weekly for 6 weeks
Erythropoetin          600U/kg at 21 and 14 days prior to surgery and 300U/kg on day of
                       surgery.
Tranexamic Acid        1g x4/day either i.v. or oral
Aprotinin              500,000U over 10 mins, followed by 200,000U/hr until bleeding stops
Vasopressin            0.3 micrograms/kg in 100ml 0.9%NaCl, i.v. over 20 minutes x1/day.
Vitamin K              10mg i.v. x 1/day

6.0 PERI-OPERATIVE MANAGEMENT
6.1 Pre-deposit Transfusion
This practice is now “out of favour” for all patient groups. The service is not available from
the National Blood Service.

It is not an acceptable alternative for Jehovah’s Witnesses.

For those who are not J.W. please be aware this service is not available at D.V.H (we are
not licensed to bleed patients) NOR is it any longer generally available through the National
Blood Service.

6.2 Disorders of coagulation
Where disorders of coagulation contribute to blood loss, aprotinin, vasopressin, Vitamin K
and tranexamic acid may be used, though their efficacy in such situations has never been
proven.

The most experienced members of staff available should normally perform the operation or
procedure.

6.3 Reduction of intra-operative blood loss.
General measures that may be considered to reduce blood loss during surgery are:

   •   Optimal timing of surgery
   •   Experienced operator
   •   Operative techniques associated with minimal blood loss
   •   Meticulous surgical haemostasis
   •   Enlarged surgical teams
   •   Staging of complex procedures
   •   Patient position to reduce venous congestion
   •   Use of tourniquet
   •   Balloon occlusion of arteries supplying bleeding area or arterial embolisation
   •   Skin infiltration with vasoconstrictors
   •   Topical haemostatics (surgicel, oxycel, gelfoam etc.)
   •   Regional anaesthesia

6.4 Other measures to reduce the need for blood transfusion during surgery.
    • Hypotensive anaesthesia
    • Acute Normovolaemic Haemodilution
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Hospital Transfusion Committee                             Page 46 of 225
Transfusion Policy                                                        November 2005
Ref: PCD 032(v1)                                                      Status : Operational
    •   Hypovolaemic Haemodilution – may not be very effective
    •   Intraoperative blood salvage
    •   Pharmacological agents: e.g. Aprotonin, Tranexamic acid, Desmopressin
    •   Blood substitutes – perfluorocarbons, haemoglobin solutions are not currently at a
        stage of development where clinically useful.

7.0 LEGAL ISSUES
7.1 Agreement to Treat.
If by refusing transfusion, the patient has caused a shift in the the risk-benefit ratio for certain
procedures, the clinicians involved may decide not to proceed. Even if the patient accepts
the increased risks, for planned procedures, individual surgeons and anaesthetists may
decline to undertake the case.

They must refer the patient to a suitable and agreeable colleague / hospital.

When a planned case is booked for a patient who will not accept a blood transfusion, the
surgeon who will be undertaking the case should be identified as early as possible and
his/her agreement in principle obtained. Likewise the Clinical Lead of the Anaesthetic
Department should be notified in order that an appropriate anaesthetist can be allocated to
the case. Both the surgeon and the anaesthetist must sign the consent form to indicate
willingness to treat the patient within the confines of the limited consent.

The position for emergency cases is different. The clinicians’ responsible may request a
colleague’s assistance if they prefer not to be involved. However, where there is no
alternative and where delay would result in significant morbidity or mortality, they must offer
the most appropriate care to the patient, within the confines of the patient’s consent.

7.2 Adult - elective surgery
 A competent adult has an absolute right to refuse any aspect of medical treatment.

‘It matters not whether the reasons for the refusal are rational, irrational, unknown or even
non-existent” (All England Law Reports, 1992)

 If the patient is treated against their will, the tort of battery is committed.

 A written declaration of the refusal of blood products signed preoperatively is legally
 binding and cannot be revoked by the court / relative should massive blood loss
 occur whilst the patient is anaesthetised.


7.3 Children - elective surgery
All cases should be consulted with the Trust’s Legal Department.

Full and frank discussion should take place between the surgeon, anaesthetist and parents
of the child and the child if considered Gillick competent.

Try and take into account the wishes of the parent/child.

Either parent may sign a consent form permitting a transfusion.

Most routine operations on children do not require or involve blood transfusion.

If it is thought that the need for transfusion is extremely unlikely, the usual
arrangements can be made to proceed with the operation with the parents being
invited to sign appropriate forms signifying their objection to blood transfusion.

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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 47 of 225
Transfusion Policy                                                     November 2005
Ref: PCD 032(v1)                                                   Status : Operational

Recognising that misjudgement can occur and that occasionally a transfusion can
unexpectedly be required it is appropriate to say to the parents that:

‘I will not let your child die for want of a blood transfusion’.

If parents refuse transfusion and you feel blood transfusion may be necessary, apply to the
court for a ‘specific issue order.’ This provides legal sanction for a specific action such as
administration of blood but does not take all the legal rights from the parents (Appendix 2).

7.3.1 Children who may give consent against parents wishes.
Children over 16 have a statutory right to consent to treatment (inc. blood
transfusion) in their own right..

Children over 12 years can also give consent to receive blood if they have sufficient
understanding and intelligence of the issues involved (‘Gillick – Competent’).

Such consent cannot be over-ridden by the parents without a court order

7.3.2 Children who refuse consent to transfusion
In the UK, children under 18 years cannot refuse necessary blood treatment. Parents and
the court may legally authorise it against the wishes of the child.

8.0 EMERGENCY ADMISSIONS
8.1 Conscious Adult Jehovah’s Witness Patient
 Appendix 1 summarises the procedure for a life threatening haemorrhage in an adult JW
patient.

In an emergency clinicians are obliged to provide care and must respect the
patient’s competently expressed views.

A competent adult has the right to refuse, or choose alternative, medical treatment.

In this case, obtain a written declaration of the refusal of blood products from the
patient.

This can be supplied by the patient in the form of a signed, witnessed advanced
directive (absolutely refusing blood and blood products and releasing the clinician
and the Trust from any liability arising from this refusal)
or
A completed hospital declaration form (appendix 4) for withholding consent for blood
transfusion. The original must remain with the patient and a copy placed in the
notes.

All discussions, decisions and interventions must be recorded in the medical notes

8.2 Unconscious Adult Jehovah’s Witness Patient
A signed and witnessed advance directive card absolutely refusing blood and releasing
clinicians from any liability arising from this refusal found on the patient or produced by
relatives / GP must be respected unless there is some reason to suppose that the patient
has changed view since the directive was executed.

An unambiguous and informed advance directive made by a competent patient is as valid as
a contemporaneous refusal.

A copy should be placed in the patient’s notes.
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Hospital Transfusion Committee                             Page 48 of 225
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Ref: PCD 032(v1)                                                   Status : Operational

If no such directive is readily available, the doctor will be expected to act in the best interest
of the patient, which may involve giving blood.
Treatment necessary to preserve the life, health or well being of an unconscious patient may
be given without consent.

Relatives or associates have no legal right to decline treatment on the patient’s behalf.

Where possible the senior doctors should discuss what is happening with the relatives.

A clear signed, dated and timed entry of all the steps taken must be documented in the
patient’s notes.

8.3 Paediatric Jehovah’s Witness
The parents should be carefully and completely counselled concerning the immediate or
anticipated requirements for transfusion support. All communications should be documented
in the patient’s notes.

Doctors can give life saving transfusions to a child despite parental refusal.

A doctor may face criminal prosecution if a child has come to harm because necessary
treatment was deliberately withheld.

If time permits, two doctors of Consultant status should make an unambiguous, clear and
signed entry in the clinical notes that blood transfusion is essential, or likely to become so, to
save life or prevent serious permanent harm.

If need for transfusion is not immediate and both parents and the child refuse blood, the
legal department should be informed so that a ‘Specific Issue Order’ can be obtained from
the court in order to administer legally the blood transfusion. Out of hours the on-call
manager can obtain the order.

9.0 PATIENTS SUFFERING FROM MENTAL DISORDER
Some patients suffering from mental disorder are incapable of making decisions regarding
their medical treatment.

The BMA state that to demonstrate capacity individuals should be able to:

   •   Understand in broad terms and simple language what the medical treatment is, its
       purpose and nature;
   •   Understand its principal benefits, risks and alternatives;
   •   Understand in broad terms what will be the consequences of not receiving the
       proposed treatment;
   •   Make a free choice (i.e. free from undue pressure);
   •   Retain the information long enough to make an effective decision

All assessments of an individual’s capacity should be fully recorded in the patient’s medical
notes. In case of uncertainty, contact the hospital’s legal department (BMA 1995).

10.0 FOETAL VERSUS MATERNAL RIGHTS
A woman’s right to refuse treatment prevails over her unborn child’s need for medical
assistance. (R v Collins 1998)

Therefore, a pregnant woman who is competent must not be transfused against her will,
even if her own life (or that of the unborn child) depends on a blood transfusion.

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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 49 of 225
Transfusion Policy                                                              November 2005
Ref: PCD 032(v1)                                                            Status : Operational

11.0 WOMEN IN LABOUR, REFUSING A BLOOD TRANSFUSION
Ensure the Consultant Obstetrician and Anaesthetist are aware a Jehovah’s Witness (or
person refusing blood) has been admitted in labour.

These patients should have their third stage of labour actively managed with oxytocic drugs
together with early cord clamping and controlled cord traction after placental separation.

Do not leave the patient alone for the first hour after delivery.

11.1 Risk factors predisposing to postpartum haemorrhage
If the patient has any of the following risk factors, consider an i.v. infusion of oxytocin after
delivery.
     • Previous history of bleeding, post or antepartum haemorrhage
     • Prolonged labour, especially when augmented with oxytocin
     • Increased maternal age, >40 years
     • Increased obesity
     • Multiple pregnancy and/or > 4 children
     • Difficult delivery
     • Abnormal placentation / retained products
     • Large baby > 3.5 kg
     • Polyhydramnios
     • Fibroid.

11.2 Actively haemorrhaging patient
See Trust Policy, Obstetric & Gynaecology Policy 22:- Obstetric Haemorrhage

12.0 References and Sources of Further Information.
British Medical Association (BMA) 1995 Report of the BMA and the Law Society, Assessment of mental capacity,
December: 65-68, 72-75

R v Collins 1998 et al, ex parte S (The Independent, 12 May 1998)

Anaesthetic Management of Jehovah’s Witnesses. C Timberlake, I Winkler. Anaesthesia Review 15; 153-167

Haematological care of the Jehovah’s Witness patient. British Journal of Haematology, 2002, 119, 25-37

Code of Practice for the surgical management of Jehovah’s Witnesses. The Royal College of Surgeons of
England 1996

Management of anaesthesia for Jehovah’s Witnesses. The Association of Anaesthetists of Great Britain and
Ireland; March 1999 9




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 50 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




                  Transfusion Policy
                      Appendix 6
               Prescribing a Transfusion

                     Date: November 2005

                     Ref : PCD 032 – A6

                     Vers : 1


      Policy Profile
      Policy Reference Number
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 51 of 225
Transfusion Policy                                           November 2005
Ref: PCD 032(v1)                                         Status : Operational


                                Transfusion Policy
                                    Appendix 6
                             Prescribing a Transfusion



Contents

1.0    Introduction
2.0    Aims and objectives
3.0    Scope
4.0    Prior to prescribing
4.1    Relevant Trust Transfusion Guidelines
4.2    Checklist:
5.0    Prescription
5.1    Other medication:
6.0    Post transfusion evaluation.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 52 of 225
Transfusion Policy                                                     November 2005
Ref: PCD 032(v1)                                                   Status : Operational

                                    Transfusion Policy
                                        Appendix 6
                                 Prescribing a Transfusion

1.0 Introduction
Because of the inherent risks associated with transfusion, it is desirable that patient
exposure to donor blood products is minimized and justified.

2.0 Aims and objectives
In all cases, the benefits of transfusing a patient will outweigh the potential risks involved.

3.0 Scope
All staff involved in the transfusion process.

4.0 Prior to prescribing
Blood and Blood components can only be prescribed by a qualified medical practitioner or
approved nurse practitioners with responsibility for care of the patient.

The person prescribing will have obtained or verified the patients consent to transfusion.
Acknowledgement of patient consent should be recorded on the prescription.

The rationale for transfusion, including baseline and target clinical and laboratory parameters
should be recorded. This information is required for the Integrated Care Pathway (ICP).

To assist in prescribing please refer to Trust Transfusion Guidelines.

4.1 Relevant Trust Transfusion Guidelines
Appendix 4    Consent to transfusion.
Appendix 7    MSBOS
Appendix 12 Guidelines for the use of Red blood cells
Appendix 16 Guidelines for the use of Platelets
Appendix 17 Guidelines for the use of F.F.P. and Cryoprecipitate
Appendix 21 Guidelines for the use of Albumin
Appendix 20 Guidelines for the use of Anti D immunoglobulin
Appendix 26 Neonatal Transfusion Policy

4.2 Checklist:
Check the following before prescribing:

   •   Patient’s Full Name
   •   Date of Birth
   •   Hospital Number
   •   Type of blood component, including special requests
   •   Quantity of blood component.


   •   Duration of transfusion
   •   Special Instructions
   •   Previous Reactions
   •   Indication for transfusion
   •   Pre-transfusion haemoglobin (or platelet count or clotting screen)
   •   Patient Information leaflet (has been offered to the patient)


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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 53 of 225
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Ref: PCD 032(v1)                                                  Status : Operational
5.0 Prescription
Prescriptions for blood products must be clear and unambiguous.

Each unit must be individually prescribed and the prescription must include the full name of
the component and the volume required. Blood products may be prescribed as “Units” in
adult patients but should be expressed in millilitre (ml) for paediatric patients.

The prescription should stipulate any special requirements e.g. gamma-irradiated, CMV
sero-negative blood etc.

5.1 Other medication:
If oral Frusemide (diuretic) is to be given during the transfusion, it should be prescribed on
the patient’s drug chart and given with the first unit.

No medication or other substance should be ever be infused via the same cannula with a
blood transfusion.

In theatres the Anaesthetist must document the administration of all blood products
on the ICP.

6.0 Post transfusion evaluation.
Document in the patients notes whether the desired outcomes were achieved and detail the
occurrence and management of any adverse events.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 54 of 225
Transfusion Policy                                                       November 2005
Ref: PCD 032(v1)                                                     Status : Operational
Appendix 1                     Emergency Adult Flow-Chart


                                      Life Threatening
                                      Haemorrhage In
                                      Adult Jehovah’s
                                           Witness

  Conscious                                                                 Unconscious




 Explain need for blood and                              Signed and witnesses advanced
 potential consequences of not                           directive card absolutely refusing
 receiving it – preferably in the                        blood and releasing clinicians
 presence of a relative/associate                        from any liability arising from
                                                         refusal



 Accepts blood         Refuses                           Found on               Not readily
                       blood                             patient or             available
                                                         Obtained from
                                                         relative/GP




                In the presence of a                     No evidence
                witness –                                that patient
                Obtain copy of valid                     has changed
                advance directive or                     their view
                complete hospital
                declaration form for
                withholding consent for
                blood transfusion




Give blood              Do not give blood           Do not give blood             Give blood to
                        Consider alternatives       Consider alternatives         save life




                     DOCUMENT EVERYTHING IN THE NOTES




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 55 of 225
       Transfusion Policy                                                        November 2005
       Ref: PCD 032(v1)                                                      Status : Operational

       Appendix 2              Paediatric Emergency and Elective Flow Chart



If LIFE THREATENING.               Both parents refuse consent              CHILD GIVES CONSENT
Take second opinion                for essential transfusion for            (16 years or Gillick
and give lifesaving                immediate or anticipated                 competent)
transfusion.                       need.                                    Respect wishes
Document fully
Inform legal department.



                                    If non-emergency, approach
                                    Trust Legal Department /
                                    Duty Manager for legal
                                    advice.
                                    Keep parents informed




                            Trust solicitors will contact an Official
                            Solicitor who will act on the child’s behalf.




                             Trust will apply to the High Court for a
                             Specific Issue Order allowing blood
                             transfusion




                            Public hearing with doctors giving evidence.
                            The parents may be heard and have legal
                            representation




                            Court gives ruling and trust doctors
                            proceed according to court ruling.




       __________________________________________________________________________
       Dartford and Gravesham NHS Trust
       Hospital Transfusion Committee                             Page 56 of 225
       Transfusion Policy                                                    November 2005
       Ref: PCD 032(v1)                                                  Status : Operational
       Appendix 3      Adult Elective Surgery Flow-Chart (Significant Risk of Bleeding)


                        Patient scheduled for surgery with which there
                        is risk of significant bleeding.
                        i.e. patient would have G&S or crossmatch.



                    At least 6 weeks prior to surgery the surgical Team will:-




      Preoperative investigations                     Informing a planning team consisting
      including:                                      of Consultant Surgeon
      FBC, coagulation screen                            Consultant Anaesthetist
      haematinics, U&E, LFT                              Consultant Haematologist
                                                         Transfusion Practitioner



                  Anaemic



      Yes                       No                      If possible, all meet with patient 4-6
                                                        weeks prior to surgery with results of
                                                        investigations.

Investigate and
treat with Fe,
Folate or Vit               Optimise
B12. If                     cardiovascu
appropriate                 lar and                      Discuss and agree how to proceed
consider the                respiratory
use of                      disease
erythropoietin




Stop NSAIDs and aspirin 2 weeks prior
to surgery




2-3 Days prior to surgery covert patients                 Complete hospital declaration form for
on warfarin to heparin or stop                            withholding consent for blood transfusion
anticoagulant if appropriate                              in the presence of a witness




       __________________________________________________________________________
       Dartford and Gravesham NHS Trust
       Hospital Transfusion Committee                             Page 57 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
Appendix 4.     Adult Elective Surgery Flow-Chart (Minimum Risk of Bleeding)



                     Patient scheduled for surgery where
                     there is minimal risk of bleeding




                     Perform FBC and clotting screen




                     If anaemic prescribe Fe if appropriate




                     Follow usual procedure for admission




                     Ensure surgeon and Anaesthetist are
                     aware




                     Prior to surgery, complete hospital
                     declaration form for withholding consent
                     for blood transfusion in the presence of a
                     witness.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 58 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational
Appendix 5            Contacts

Consultant Anaesthetist Darent Valley Hospital

Consultant Haematologists Darent Valley Hospital
Dr R Ezekwesili Ext 8505
Out of hours via Switchboard
Email Raphael.Ezekwesili@dag-tr.sthames.nhs.uk

Specialist Practitioner of Transfusion
Leslie Delieu Ext 4666
Email Leslie.Delieu@dag-tr.sthames.nhs.uk

Mike Flynn
Chairman
Hospital Liaison Committee for J.W.’s Maidstone
78 Middleton Close
Rainham
Gillingham
Kent ME8 9LR
Tel/Fax 01634 361640
Mobile 07905 163949

Hospital Liaison Committee
Hospital Information Services (Britain)
Watch Tower,
The Ridgeway
London NW7 1RN
Tel: 0208 906 2211
Fax: 0208 343 0201
Email: his@wtbs.org.uk

Local Hospital Liaison representative

Legal Services Manager




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 59 of 225
    Transfusion Policy                                                  November 2005
    Ref: PCD 032(v1)                                                Status : Operational

    CONSENT FORM The form below has been provided by the Trust Solicitors.
                    DARTFORD and GRAVESHAM NHS TRUST
                     Consent Form (this is a three page form)

For the use by Jehovah’s Witness: to exclude the use of blood transfusion or blood
   components.

       This consent form excludes the transfusion of blood or blood components but does
          include the administration of non-blood volume expanders such as Dextran,
          Haemaccel, Hetastarch.

    The patient’s express refusal of all blood and components is absolute and cannot be
    overridden by any person, relative, health professional or court order. Such refusal remains
    irrevocably in force even though the patient may be affected by medication, unconscious or
    in a life threatening situation.

    The patient must be aware of all the implications that a refusal of blood transfusion or blood
    components may have. Such refusal may be life threatening.


    Patient Details / PAS Label

    Surname……………………………………………………………………..

    Forenames…………………………………………………………………..

    Date of Birth …………………….. Hospital Number ……………………

    Responsible Health Professional …………………………………………
    (Usually Consultant)

    Special Requirements ……………………………………………………..
    (e.g. other language/other communication method)


    References     Consent Policy
                   Advance Directive Guidelines (UK ethics network May 2000)
                   Department of Health Guidelines
                   GMC/RCN Guidelines
                   Hospital Information Services for Jehovah’s Witnesses


       Declaration For Withholding Consent For Blood Transfusion And Blood Products
          During Medical Treatment at Dartford and Gravesham NHS Trust




                                               Page 1

                                 To be retained in patient’s notes



    __________________________________________________________________________
    Dartford and Gravesham NHS Trust
    Hospital Transfusion Committee                             Page 60 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
Name of proposed procedure or course of treatment (include a brief explanation if
medical terms are not clear) …….. …….. ………… ……… ………. ………….. …..
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
………………………………………………………………………..….

Statement of health professional – to be filled in by a health professional with appropriate
knowledge of proposed procedure, as specified in consent policy)

I have explained the procedure to the patient. In particular I have explained:

The intended benefits ………………………………………………………………………
.…………………………………………………………………………………………………………
……………………………………………………………………………………………………………
………………………………………………………………………………

Serious or frequently occurring risks ………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………
I have explained and emphasised my clinical opinion of potential risk of refusing blood or
blood components, which may be necessary during th course of the operation or
treatment. I have explained such refusal may be life threatening. I acknowledge the
patients right to refuse blood or blood components and agree that the treatment of this
patient will not include the transfusion of blood or blood products under any circumstances.

I have also discussed what the procedure is likely to involve, the benefits and risks of any
alternative treatments (including no treatment) and any particular concerns of this patient.

□ The following information has been provided…………………………………………..

This procedure may involve:

□ General and/or regional anaesthesia        □ local anaesthesia           □ sedation

which will be further discussed by your anaesthetist

Signed…………………………………                                    Date ……………………………..
Name (print) …………………………                                Job Title ………………………….

Statement of interpreter (where appropriate)

I have interpreted the information above to the patient to the best of my ability and in a way
which I believe s/he can understand.

Signed…………………………………                                    Date ……………………………..
Name (print) …………………………

                              To be retained in patient’s notes.

                                           PAGE 2




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 61 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
Statement of patient

Please read this form carefully. If your treatment has been planned in advance, you should
have already seen page 2, which describes the benefits and risks of the proposed treatment.
If you have any further questions do ask – we are her to help you. You have the right to
change your mind at any time, including after you have signed the form.

I agree to the procedure or course of treatment described on this form.

I understand that you cannot give me a guarantee that a particular person will perform the
procedure. The person will, however, have appropriate experience.

I understand that any procedure in addition to those described on this form will only be
carried out if it is necessary to save my life or to prevent serious harm to my health.

As a Jehovah’s Witness I adamantly refuse the transfusion of blood, or blood
components under any circumstances, even though such refusal may be life threatening.

In signing this consent form you are accepting full legal responsibility for your
decision to refuse blood and blood components and release all those treating
you from any liability for any adverse consequences directly arising from their
management options being curtailed by the exclusion of blood or blood
components.

I have been told about significant foreseeable procedure, which may become necessary
during my treatment. I have listed below any procedures, which I do not wish to be carried
out without further discussion………………………………………..
……………………………………………………………………………………………………………
……………………………………………………………………………………….

Patient’s signature………………………………..                     Date……………………………
Name (print) ………………………………………

Confirmation of Consent (to be completed by heath professional when the patient is
admitted for the procedure, if the patient has agreed in advance)

On behalf of the team treating the patient, I have confirmed with the patient that s/he has no
further questions and wishes the procedure to go ahead.

Signed………………………………..                                  Date ……………………………..
Name (print) …………………………                               Job Title …………………………

□ See also advanced directive/living will.

                             To be retained in patient’s notes.

                                             PAGE 3




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 62 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




             Transfusion Policy
                Appendix 7
        Maximum Surgical Blood Order
             Schedule (MSBOS)



                     Date: November 2005

                     Ref : PCD 032 – A7

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032-A7
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 63 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational
                              Transfusion Policy
                                  Appendix 7
                 Maximum Surgical Blood Order Schedule (MSBOS).

Content


1.0    Introduction
2.0    Requesting Blood for Surgery
3.0    Audit of MSBOS
4.0    MSBOS Table




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 64 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
                              Transfusion Policy
                                  Appendix 7
                 Maximum Surgical Blood Order Schedule (MSBOS).

1.0    Introduction
The MSBOS is a schedule for the maximum provision of red blood cells for common
operations requiring intraoperative blood transfusion. However it does not preclude further
blood being requested in response to specific clinical need.

The MSBOS has been agreed by the appropriate clinical leads and consultants.

2.0  REQUESTING BLOOD FOR SURGERY
An MSBOS table can be found in the table below.

Blood Bank will routinely provide no more than the designated amount of red cells, although
orders for fewer units will be followed.

It is mandatory that the name of the operation, is specified on the request form otherwise no
blood will be issued.

The date of operation will be required otherwise no blood will be issued

If the surgeon feels that the amount of blood listed on the MSBOS is insufficient for a
particular patient’s clinical condition, they should clearly state the reasons on the request
form.

If the maximum order is a ‘group and screen’ (G&S), the surgeon should send a sample for
pre-transfusion testing:

If no red cell antibodies are detected, the sample will be retained within the Blood Bank for
14 days.

3.0    AUDIT of MSBOS
The Maximum Surgical Blood Order Schedule will be audited and reviewed regularly to
allow;

   •   Reduction in workload of unnecessary crossmatching.
   •   Improved stock management and wastage.
   •   The ‘tariff’ to be agreed by all parties.
   •   For change in clinical practice that may lead to changes in blood requirements.
   •   For regular monitoring of practice.

Blood is a valuable and increasingly scare resource, and strategies for both effective use
and avoidance of transfusion are an important part of clinical practice.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 65 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
             MAXIMUM SURGICAL BLOOD ORDER SCHEDULE TABLE

                       GENERAL SURGERY                                         ORDER
AA Repair                                                                 6
Above Knee Amputation                                                     G&S
Below Knee Amputation
Anterior Resection                                                        2
Carotid Endarterectomy                                                    G&S
Colectomy                                                                 2
Hemi-colectomy                                                            G&S
ERPC                                                                      G&S
Gastrectomy                                                               G&S
Hernia Repair                                                             G&S **
Intestinal Obstruction                                                    G&S **
IPOP                                                                      G&S
FPOP                                                                      2
Lap. Cholyscystectomy                                                     G&S
Laparotomy                                                                G&S **
Liver Biopsy                                                              G&S
Mastectomy                                                                G&S
Open Cholysystectomy                                                      G&S
Panproctocolectomy                                                        2
Splenectomy                                                               4
Thyroid Surgery                                                           G&S
Wide Local Excision                                                       G&S

** Until further information is given to the blood bank by the surgical team

                             UROLOGY                                      ORDER
TURP                                                                      G&S
TURBT
TART

Cystectomy                                                                6
Nephrectomy                                                               4
Radical Prostatectomy                                                     4
Retropubic Prostatectomy                                                  4

                          ORTHOPAEDIC                                     ORDER
Disc Surgery                                                              G&S
Fractured Neck of Femur                                                   G&S
Fractured Shaft of Femur                                                  G&S
Laminectomy                                                               G&S
ORIF – all types                                                          G&S
Total Hip Replacement (THR)                                               2
Revision of THR                                                           4
Total Knee Replacement (TKR)                                              G&S
Total Shoulder Replacement (TSR)                                          2




                     OBSTETRICS and GYNAE                                 ORDER
Abruption                                                                 G&S
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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 66 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational
APH                                                            G&S
Breech                                                         G&S
Colposuspension                                                G&S
Ectopic Pregnancy                                              G&S
ERPC                                                           G&S
Foetal Distress                                                G&S
Hysterectomy – Abdo                                            G&S
Hysterectomy – Vaginal                                         G&S
Hysterectomy – with malignancy                                 2
Inevitable Abortion                                            G&S
LSCS Hb >9.0g/dl                                               G&S
LSCS Hb <9.0g/dl                                               2
Menorrhagia                                                    G&S
Miscarriage                                                    G&S
Miscarriage – Incomplete or threatened
Placenta Praevia                                               As Requested
P.P.H.                                                         Variable
Pre-Eclamptic Toxaemia                                         G&S
P.V. Bleeding                                                  G&S
Retained Placenta                                              G&S
Spontaneous/Surgical Rupture of Membranes                      G&S
Termination of Pregnancy                                       G&S
Transcervical Resection Of Endometrium                         G&S
Vulvectomy                                                     G&S




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 67 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




                Transfusion Policy
                    Appendix 8
             Requesting Blood Products



                     Date: November 2005

                     Ref : PCD 032 – A8

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032-A8
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 68 of 225
Transfusion Policy                                                November 2005
Ref: PCD 032(v1)                                              Status : Operational
                                Transfusion Policy
                                    Appendix 8
                             Requesting Blood Products

Contents

1.0     Introduction
2.0     Scope
3.0     Aims and Objectives
4.0     Written requests – Pathology request forms
4.1     High risk patients
4.2     Transfusion history.
4.3     Unconscious Unknown patient.
5.0     Telephone requests
6.0     Requesting red blood cells
6.1     Group and Save Serum (Group and antibody screen)
6.2     Crossmatch (Compatibility Test)
6.3     Routine requests
6.4     Requesting Blood for Elective Surgery.
6.5     Further units
6.6     Requesting uncrossmatched blood in an emergency
6.6.1   Issuing group specific blood.
6.6.2   Issuing O Rh D negative (flying squad) blood
6.7     Patients with antibodies
7.0     Requesting Fresh Frozen Plasma and Cryoprecipitate.
8.0     Requesting Platelets
8.1     Routine requests
9.0     Requesting Anti-D Immunoglobulin
10.0    Requesting Human Albumin Solutions




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 69 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational

                                  Transfusion Policy
                                      Appendix 8
                               Requesting Blood Products

1.0 Introduction
All blood products must be prescribed and ordered by medical staff for a named patient. It is
important these staff understand the processes involved in the provision of blood as there
are a number of ways in which blood products can be made available and a breakdown in
the system may delay the provision of blood.

2.0 Scope
All staff involved in the transfusion process.

3.0 Aims and Objectives
Blood products are available for patients at the time expected.

4.0 Written requests – Pathology request forms
Requests are made on a pathology “Blood Transfusion” pink form, code WOL 012

Complete all boxes on this request form as all of the information is important. The
information is needed to adequately manage the patient, blood stocks, information on the
blood bank computer and the blood budget.

To prevent avoidable, unnecessary delays, please ensure that all entries are legible and the
request form is signed.

Clinical/surgical details help to ensure the appropriateness of the request and the selection
of the correct product for the patient. They are coded for audit purposes. Details such as
“pre-op” or “unwell” are not specific and will be queried.

The Biomedical Scientist has the discretion to request the clinician discuss blood product
requirements with a Consultant Haematologist prior to issue.

Please note that a request for crossmatch will not be performed unless the date required is
specified.

4.1     High risk patients
In line with the rest of Pathology, requests for patient whose samples pose a potential
infection risk e.g. suspected or confirmed Hep B, Hep C, HIV infection, should be labelled
accordingly.

4.2      Transfusion history.
It is important the blood bank know the patient’s transfusion history. Provided you use the
correct hospital number, they will be aware of past transfusions at D.V.H.

Should your patient have been transfused at another hospital, or had a bone marrow or a
solid organ transplant, please include this on the request form.

4.3 Unconscious Unknown patient.
If the patient is unconscious and unknown a unique name & number must be issued for the
patient by A&E to provide a form of identification. This is usually, for example, “Unknown
male 1”. They will, and must, have a unique hospital number.



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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 70 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
Crossmatching these patients is a risky procedure, To minimize error, it is important that the
form completion and sample collection are performed by the same person as one continuous
process.

Further information about patient identity should be forwarded to the blood bank as it
becomes available. You may be asked for a repeat sample once the patient’s demographics
are known, so that the computer history and transfusion related paperwork can be updated.

5.0 Telephone requests
Telephone requests can be made for crossmatching from an existing sample, for Fresh
Frozen Plasma, Cryoprecipitate or Platelets by contacting the blood bank on ext 8502.

The use of verbal rather than written instructions, increases the potential for error. To avoid
mistakes, the request should be very clear. You will be asked for same information as is on
the form. Please ensure you have full patient demographics available.

6.0 Requesting red blood cells
The blood bank offers two stages of readiness to meet expected blood needs.

6.1 Group and Save Serum (Group and antibody screen)
This procedure avoids the need to set aside blood units for a given patient. The patient’s
ABO and Rh (D) group is determined and the patient’s serum is tested for the presence of
unexpected red cell antibodies.

The specimen is then stored for 14 days.

6.2 Crossmatch (Compatibility Test)
If your patient requires red blood cells, please be specific in providing the date and time of
when blood is required, number of units and any special requirements e.g. CMV negative,
irradiated etc

The blood bank, in addition to the procedures carried out for a group and antibody screen,
select and test the units of blood for compatibility. This “crossmatch” will take 45-60
minutes. .

6.3 Routine requests
Routine cross-match requests should be made 24 hrs before the blood is required.


Because samples are currently “batch tested” routine samples arriving at the laboratory after
13:00 hrs may not be dealt with until the following morning.

Compatible units of blood are labelled specifically for the patient and are held until the 2nd
morning after the day required. e.g. blood ordered for Monday will be returned to stock on
Wednesday morning.

If the units need to be held for longer this may be arranged between the patient’s
clinician/midwife and the Blood Bank.




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 71 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational
6.4 Requesting Blood for Elective Surgery.
Blood requirements for elective surgical procedures can be predicted from analysis of
previous use.

The blood bank, with the surgical teams, have agreed a Maximum Surgical Blood Ordering
Strategy. (see Guideline for Ordering Blood for elective Surgery - MSBOS).

It is important to clearly indicate the operation to be undertaken. If more units of blood are
required than indicated in the MSBOS, the reason for this must be clearly indicated.

6.5 Further units
If further units are required for the patient within two days, they can be provided from the
same sample.
     • Group and Save / crossmatch samples are held for 14 days and are available for
         crossmatching on patients who have not been recently transfused.
            o If the patient was transfused within the last 2 – 14 days the sample must be
                taken within 24 hours before transfusion.
            o If the patient was transfused within the last 15 – 28 days the sample must be
                taken within 72 hours before transfusion.
            o If the patient is pregnant the sample should be taken within 72 hours before
                transfusion.

6.6 Requesting uncrossmatched blood in an emergency
In an emergency situation the degree of urgency should be discussed with blood bank
personnel and appropriate transport arrangements made (ext 8502 or bleep out of hours).

6.6.1 Issuing group specific blood.
When the situation warrants immediate action, and the risk of not transfusing outweighs the
risk of waiting for a crossmatch, provided the blood bank have a suitable sample available,
blood of the patient’s ABO and Rh type can be provided in 10 minutes.

6.6.2 Emergency Issue O Rh Negative (flying squad blood)
This is requested in exceptional circumstances only, when the situation warrants immediate
action and a sample is not available. It is obtained via blood bank staff.

Where the use of O Rh D negative blood is indicated, no more than 2 units should be used,
during which time the patient’s blood group should be established and a switch to group
specific blood made.

A transfusion sample for crossmatch testing must be taken prior to commencing transfusion
with emergency O Rh D negative blood.

See Appendix 14 Use of O Rh D negative blood

6.7 Patients with antibodies
Please give the blood bank adequate notice to provide blood for patients known to have
antibodies.

It is probable that selected, antigen negative, blood may need to be obtained from the
National Blood Service at Tooting, and then crossmatched. This may substantially increase
the time required to make blood available.

Check TPath. If your patient has antibodies, check with blood bank staff the estimated time
required to provide blood.


__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 72 of 225
Transfusion Policy                                                     November 2005
Ref: PCD 032(v1)                                                   Status : Operational
7.0 Requesting Fresh Frozen Plasma and Cryoprecipitate.
These products do not require crossmatching, but they do need to be blood group specific.

Inappropriate requests for these products bring about the Trust’s biggest wastage costs.
Once thawed, these products have a 24 hour shelf life, and if not used for the patient
identified are likely to be wasted. PLEASE BE ABOLUTELY SURE the product will be used
before making the request.

They can be requested by telephone after the transfusion laboratory has received a sample
to ascertain the patient’s blood group. The laboratory will use the historic group if the patient
has been grouped on at least two occasions.

8.0 Requesting Platelets
These products do not require crossmatching, but they do need to be blood group specific.

They can be requested by telephone after the transfusion laboratory has received a sample
to ascertain the patient’s blood group. The laboratory will use the historic group if the patient
has been grouped on at least two occasions.

Platelets are not held as a stock item and need to be obtained from the N.B.S. Tooting which
takes 2-3 hours.

8.1 Routine requests
Routine orders for platelets Monday – Friday, e.g. Chemotherapy patients, should be placed
before 09.30hrs. for an afternoon delivery and before 3p.m for next day delivery.

9.0 Requesting Anti-D Immunoglobulin
Requests for anti D immunoglobulin may be made by
    • Hospital Doctors.
    • Qualified midwives.
    • GPs making requests for community administration.
    • Senior nursing/midwifery staff as delegated by the Directorate. The General Manager
       and Clinical Director will be responsible for the identification of appropriate staff and
       for any requests made by these staff.

Blood bank staff will insist that an appropriate sample is available or will be taken prior to the
administration of anti D.

10.0 Requesting Human Albumin Solutions
These products are obtained from Pharmacy. They do not require group or compatibility
testing prior to issue.




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 73 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




                      Transfusion Policy
                         Appendix 9

Sample Collection, Timing and Testing.


                     Date: November 2005

                     Ref : PCD 032 – A9

                     Vers : 1

      Policy Profile
      Policy Reference Number     PCD 032-A9
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 74 of 225
Transfusion Policy                                                 November 2005
Ref: PCD 032(v1)                                               Status : Operational
                                Transfusion Policy
                                    Appendix 9
                        Sample Collection, Timing and Testing


Contents

1.0      Introduction
2.0       Aims and Objectives
3.0       Scope
4.0       “Phlebotomists”
5.0       Identifying the patient.
6.0      Sample bottle
6.1      Adult sample
6.2      Paediatric samples
7.0      Venepuncture
8.0      Sample labelling.
8.1      The Unknown Patient
8.2      Samples from patients in community / out patient settings.
9.0      Sample Rejection
9.1      Under-filled samples
9.2      Clotted samples
9.3      Inadequately or incorrectly labelled samples
10.0     Timing of Sample Collection In Relation To Previous Transfusions
10.1     Transfused patients
10.2     Pregnant women
10.3     Life threatening/emergency situations
11.0     Testing Transfusion Samples
11.1     Group and Save samples:
11.2     Compatibility testing
11.2.1   Crossmatching
11.2.2   Issue of Uncross-matched blood
12.0     Requests for Other Blood Products.
13.0     De - reserving blood products.
14.0     Cord blood group and maternal Kleihauer.
15.0     Antibody investigations
15.1     Antibody titre / quantitation
16.0     White cell and platelet investigations




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 75 of 225
Transfusion Policy                                                      November 2005
Ref: PCD 032(v1)                                                    Status : Operational
                                 Transfusion Policy
                                     Appendix 9
                         Sample Collection, Timing and Testing

1.0 Introduction
Sample collection is fundamental to the safety of Blood Transfusion yet it is often left to the
least experienced medical staff. There are strict guidelines from the British Committee for
Standards in Haematology (BCSH) on which this appendix is based.

2.0 Aims and Objectives
To ensure safe phlebotomy practice and appropriate timing of samples for transfusion.

3.0 Scope
All involved in the transfusion process, including phlebotomy.

4.0 “Phlebotomists”
The sample may be taken by an appropriately trained doctor, nurse, midwife or phlebotomist
HCA or Biomedical Scientist. Their training should be recorded.

5.0 Identifying the patient.
ALL patients, including unconscious and day-case patients, must have identity bands. These
should state the patient’s surname, first name, sex, date of birth and hospital number.

If an identity band is removed, for example to site a cannula, it is the responsibility of that
person to apply a new one

Only bleed one patient at a time.

Where the patient is able to communicate, full name and date of birth shall be confirmed with
the patient and checked against their wristband.

The identity details, name, date of birth and hospital number, must match those on the
patients wristband and the request form.

6.0 Sample bottle
6.1 Adult sample
Collect the sample into a 6ml EDTA Transfusion tube (pink top).
N.B. use the Vacutainer system, it reduces the risk of sample haemolysis and sample
leakage.

6.2 Paediatric samples
For infants less than 4 months old a sample must be taken from the mother as well as the
child.

For neonates send 0.5 ml EDTA sample
For children 4 months to 2 years send 1ml EDTA sample
For children 2 years – 10 years send 3ml EDTA sample.
For children over 10 years send 6 ml EDTA sample

N.B. Paediatric samples also must be labelled in accordance with the guidelines.

7.0 Venepuncture
It is important that the tube is correctly filled and that the blood is not haemolysed or clotted.
If in doubt it is better to take the sample again rather than delay the transfusion or further
inconvenience the patient later.

__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 76 of 225
Transfusion Policy                                                       November 2005
Ref: PCD 032(v1)                                                     Status : Operational

8.0 Sample labelling.
Label samples at the bedside, immediately after collection from the patient.

The sample tube must be labelled with:
   • Unique patient number. (Hospital number or NHS number)
   • Surname.
   • First name.(initials not sufficient)
   • Gender.
   • Date of birth. (age not acceptable)
   • Location of patient.
   • Date and time
   • Signature of the individual taking the blood.

DO NOT USE ADDRESSOGRAPH LABELS
DO NOT PRE-LABEL SAMPLES.
DO NOT ASK ANOTHER PERSON TO LABEL A SAMPLE FOR YOU.

8.1 The Unknown Patient
Enter name and date of birth as “unknown” where this information is unavailable.
Always enter hospital number and gender.

8.2 Samples from patients in community / out patient settings.
Ask the patient to state their name, address and date of birth.
Confirm that the details correspond with those on the completed request form.
Complete the details on the sample label immediately after the tube has been filled before
leaving the patients side.
The patient’s hospital number must be included where this is known. In circumstances where
the patient does not have a hospital number, their NHS number should be stated. (or as a
final resort their post code)

9.0 Sample Rejection

9.1 Under-filled samples will be rejected as they cannot be processed on the laboratory
equipment.

9.2 Clotted samples will be rejected as they cannot be processed on the laboratory
equipment.

9.3 Inadequately or incorrectly labelled samples will be rejected.
Any details, which are discrepant with previously received information, are checked using
PAS, the hospital registration system. With the exception of A&E samples, which have their
own unique numbers, samples are not accepted without a Hospital Number.
Samples received which have been mislabelled (wrong name, date of birth etc) ,
inadequately labelled or which have not been labelled are discarded immediately.

Information regarding hospital numbers, date of birth etc is not accepted by telephone. A
fresh sample must be taken.

9.4 A report will be generated detailing the reason for rejection.

10.0 Timing of Sample Collection In Relation To Previous Transfusions
Transfusion or pregnancy may cause a primary or secondary immune response and
samples selected for crossmatching or antibody screening must take account of this,
so that newly developed antibodies are detected.
__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 77 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational

When a patient is being repeatedly transfused, it is not necessary to submit a daily
crossmatch sample. Such patients should be screened for the development of irregular
antibodies at least every 72 hours (3 days).

If a transfusion has been given more than 72 hours previously, a new sample is required
according to the following guidance:

10.1 Transfused patients
Patients transfused within:                 Sample to be taken (maximum)
3 to 14 days                                24 hours before transfusion
14 to 28 days                               72 hours before transfusion
28 days to 3 months                         1 week before transfusion
                                            (samples held for 14 days only)

10.2 Pregnant women
Immunisation is more likely to occur during the third trimester of pregnancy, therefore any
samples submitted for pre-transfusion testing must never be more than 7 days old. It is
advisable that a sample is taken immediately before transfusion or upon admission for an
elective procedure.

10.3 Life threatening/emergency situations
The medical officer or his deputy must contact the Blood Bank laboratory or the on-call
Haematology BMS out of hours, to inform them of the clinical situation. A sample for urgent
blood grouping and cross matching should be sent. It is essential that these be fully and
accurately completed as errors will delay provision of compatible blood.
To prevent samples being lost in the air tube system, consider sending a member of
staff with the sample directly to the laboratory.

11.0 Testing Transfusion Samples
11.1 Group and Save samples:
These are batch tested. Most results are available by the same working day. Samples are
saved for 14 days.

11.2 Compatibility testing
11.2.1 Crossmatching
This generally takes 45 to 60 minutes. This will be longer if ;
     • the patient has antibodies.
     • requires a special product e.g. genotyped, irradiated or CMV negative blood.
 In these circumstance please be advised by the laboratory on availability.

11.2.2 Issue of Uncross-matched blood
   • Supply of group specific blood will take 10 minutes form receipt of sample.
   • O Rh D Negative blood - for emergencies only can be available in 5 minutes. See
       Appendix 14 Use of emergency blood.

12.0 Requests for Other Blood Products.
Other blood products will be made available for the time required IF the laboratory
has a current historic blood group available for the patient. These include:
   • Fresh Frozen Plasma
   • Platelets
   • Cryoprecipitate
   • Anti D immunoglobulin.
   •
13.0 De - reserving blood products.
__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 78 of 225
Transfusion Policy                                                          November 2005
Ref: PCD 032(v1)                                                        Status : Operational
Crossmatched blood will be kept until the second morning after the date it was requested.

After this time it will be returned to stock and used for another patient. If you wish blood kept for any
longer period of time then you must inform the laboratory.

14.0 Cord blood group and maternal Kleihauer.
These are tested on the same day.

15.0 Antibody investigations
These are batch tested. Provisional results may be available by the end of the same working
day. Complex investigations are referred to NBS Tooting and results may take up to one
week.

15.1 Antibody titre / quantitation
These investigations are referred to NBS Tooting and results may take up to one week.

16.0 White cell and platelet investigations
Any tests relating to white cells and platelets must be referred through the Consultant
Haematologist. They are referred to external laboratories. Results may take up to two
weeks.
                                          Please note

Samples will be treated as routine unless a telephone request is received.

In all cases allow for phlebotomy and portering / delivery time.




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 79 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




                 Transfusion Policy
                    Appendix 10
              Blood Product Information

                     Date: November 2005

                     Ref : PCD 032 – A10

                     Vers : 1

      Policy Profile
      Policy Reference Number     PCD 032 – A10
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 80 of 225
Transfusion Policy                                                November 2005
Ref: PCD 032(v1)                                              Status : Operational
                                Transfusion Policy
                                   Appendix 10
                             Blood Product Information



Contents


1.0    Introduction
2.0    Aims and Objectives
3.0    Scope
4.0    Red Blood Cells – General Information
4.1    Plasma depleted red cells in optimal additive solution SAG-M
4.2    Irradiated red cells
4.3    Washed red cells
4.4    Frozen and thawed red cells
5.0    Fresh Frozen Plasma (FFP) and Cryoprecipitate
6.0    Platelets
7.0    Human Albumin Solution (HAS)
8.0    Anti-D Immunoglobulin
9.0    Other Products
9.1    Recombinant Factor VIIa (rFVIIa)

10     TABLE         Technical aspects of blood products




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 81 of 225
Transfusion Policy                                                      November 2005
Ref: PCD 032(v1)                                                    Status : Operational
                                   Transfusion Policy
                                      Appendix 10
                                Blood Product Information

1.0 Introduction
The National Blood Service is responsible for the collection, preparation and testing of blood
products from volunteer donors. Deliveries of the different products are made to the Hospital
Blood Bank on request routinely Monday to Friday, although “ad hoc” deliveries can be
arranged at other times

2.0 Aims and Objectives
Provide staff with an information resource.

3.0 Scope
All staff involved in the transfusion process

4.0 Red Blood Cells – General Information
Red cells may be used to treat patients where a reduction in oxygen supply to the tissues
causes a clinically significant problem.
Red blood cells must be stored correctly at a controlled temperature between 2°C and 6°C.
Incorrect storage reduces the viability of the cells and increases the risk of bacterial
contamination.
This product must only be stored in a BLOOD BANK, these refrigerators are alarmed and
the temperature is constantly recorded and monitored by the Blood Bank Staff.
The Blood Bank holds a stock of most groups.
Issue of this product requires a recent patient sample (an EDTA 6mL pink top), accompanied
by a completed Blood Transfusion Request Form to ensure compatibility between donor and
patient prior to transfusion.

Since November 1999, all red cell and platelet components have been leucodepleted, by
passage through high specification filters, which results in the removal of >99.9% of
leukocytes. This significantly reduces the risk of sensitisation to HLA antigens –so reducing
the incidence of febrile reactions; reduces the risk of CMV transmission; but was introduced
to reduce the theoretical risk of nvCJD transmission.
All red cell units are screened for Hepatitis B surface antigen, anti-hepatitis C, anti-HIV 1 and
2, but are not subject to any viral inactivation procedures, and the risk of viral, bacterial or
other infectious agents cannot be excluded.

4.1 Plasma depleted red cells in optimal additive solution SAG-M
Most red cells are supplied in this form.
SAG-M, which contains sodium chloride, adenine, glucose and mannitol is the commonly
used additive solution in the UK.
The volume is 270mL +/- 60mL.
The Haematocrit of a unit is 0.50 –0.70 and has a better flow rate than packed cells.

4.2 Irradiated red cells
Gamma irradiation of red cells is used for the prevention of transfusion-associated graft-
versus-host disease (TA-GVHD) in susceptible patients e.g. immuno-suppressed patients,
recipients of haemopoietic stem cells etc.

The red cells are irradiated within 24hr of collection and have a post irradiation shelf life of
28-days. The main hazard is excessive leakage of supernatant potassium.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 82 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
4.3 Washed red cells
These are used for patients with severe reactions to plasma proteins e.g. patients with IgA
deficiency who have developed anti-IgA antibodies. Once washed these must be used within
24 hours.

4.4 Frozen and thawed red cells
These cells are frozen at <-80oC for up to 10 years.
This allows the storage of rare donor or autologous red cells for patients who have
developed rare or combined red cell antibodies that make the provision of donor blood
difficult. Once thawed and washed they must be used within 12 hours.

5.0 Fresh Frozen Plasma (FFP) and Cryoprecipitate
These products have been separated from a unit of whole blood within 8 hours of donation
and rapidly frozen to maintain the clotting factor viability.
 It is stored for up to 1 year at <-30oC.
Before use the product must be thawed, after which it must be used, preferably as soon as
possible, definitely within four hours if stored at room temperature or 24 hours if stored in a
blood bank.
It is important to avoid thawing until it is certain that the product is to be used.

For adults the number of packs required is calculated on the abnormality of the clotting
results and the weight of the patient (12-15mls of FFP per Kg body weight), which is usually
about 3 or 4 packs. Small volume paediatric FFP is available for babies (60ml volumes).

Cryoprecipitate is ordered by ‘therapeutic dose’ which, for an adult, is ten bags each
containing approximately 30mls.

 The Blood Transfusion Department holds a stock of FFP of most blood groups and a small
stock of cryoprecipitate usually of group A or O. Cryoprecipitate is use to correct fibrinogen
deficiency.
Where the patient is not already known to the Blood Transfusion Department a sample (An
EDTA 6ml pink top specimen, accompanied by a completed Blood Transfusion Request
form) will be required prior to ordering and issue of these products

6.0 Platelets
Platelets have short shelf life (5 days). For maximum viability they must be stored at 22°C on
a continuously rotating mixer. If they are not stored correctly the platelets will clump (stick
together) and will be of no therapeutic benefit. Therefore, platelets are stored in the Blood
Transfusion Department, on dedicated equipment, and are issued to the ward immediately
prior to use.
The Blood Bank does not hold a stock of platelets. Platelets are ordered for named patients
from the National Blood Service and take 2 to 3 hours to arrive. For adults the product is
usually ordered in terms of a ‘therapeutic dose’, one bag containing approximately 300ml.

Paediatric platelets should be requested for babies (one bag containing approximately
60ml).

Where a patient is not already known to the Blood Transfusion Department a sample (an
EDTA 6mL pink top, accompanied by a completed Blood Transfusion Request form) will be
required prior to ordering and issue of this product.




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7.0 Human Albumin Solution (HAS)
Stocks of albumin are held by Pharmacy. HAS is available as 20% and 4.5% in a variety of
sizes. The product is produced from pooled donor plasma with the final product being
sterilised by filtration and heat treatment.

A sample from the patient is not required prior to the issue of this product

8.0 Anti-D Immunoglobulin
Anti-D immunoglobulin is prepared from human plasma containing high levels of anti-D
antibody. Rigorous procedures have contributed to the excellent safety record of this
product; however, the source material is human and therefore may be capable of
transmitting disease. The Blood Transfusion Department holds a stock of 250iu and 500iu
doses. The product is stored at 4°C, in the dark, and is issued to named patients on request.
A sample from the patient, to confirm the Rh (D) group and antibody status, will be generally
be required prior to the issue of this product. Be advised by the Blood Transfusion
Department

9.0 Other Products
There are other blood components such as granulocyte preparations, various
immunoglobulins and clotting factor concentrates which may, occasionally, be required.

These will be arranged through the Consultant Haematologist.

The Blood Transfusion Department will arrange for them to be delivered, although this may
require at least 24 hours notice.

9.1 Recombinant Factor VIIa
This expensive product is available for intractable bleeding due to a coagulopathy not
responding to standard treatment. This product is only available after discussion with a
Consultant Haematologist. One of dose for an average adult will cost in excess of £3500.




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Hospital Transfusion Committee                             Page 84 of 225
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Ref: PCD 032(v1)                                          Status : Operational
10 TABLE - Technical aspects of blood products
     Product     Nominal           Transfusion management in Adult Patients*.
                 Volume
Red Cells        280mL     Stored between 2°C - 6°C
                 +/-       Transfusion to commence within 30 min of removal from
                 60mL      fridge. Transfusion duration 2 - 3 hours.
                           Maximum 4 hours after removal from fridge to completion of
                           transfusion
Fresh            300Ml     Stored at <- 30°C. Thawed to 37°C in transfusion lab.
Frozen    Plasma +/-       Thawed FFP may be stored for 24hr in blood fridge, but must
(FFP)            60mL      be transfused within 4 hrs if taken to ward. Transfusion
                           duration 30 minutes
Platelets        250ml     Contains at least 240 x 109/L platelets.
                           Stored between 20°C - 24°C with constant agitation.
                           Transfusion duration 30 minutes.
                           To be completed within 1 hour of receipt from lab.
Albumin 4.5%     500ml     Stored between 4°C - 25°C
                           Infusion rate determined according to treatment regimen.
Albumin 20%      100ml     Stored between 4°C - 25°C
                           Infusion rate must not exceed 120ml per hour.
Anti – D         1.7ml     Stored between 2°C - 8°C
Immunoglobulin             Administered by I.M. injection
250 iu
Anti – D         2.1ml     Stored between 2°C - 8°C
Immunoglobulin             Administered by I.M. injection
500 iu




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Hospital Transfusion Committee                             Page 85 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




          Transfusion Policy
             Appendix 11
Guidelines on the compatibility of Blood
                Products

                     Date: September 2005

                     Ref : PCD 032 – A11

                     Vers : 1

      Policy Profile
      Policy Reference Number     PCD 032-A11
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 86 of 225
Transfusion Policy                                             November 2005
Ref: PCD 032(v1)                                           Status : Operational



                                    Transfusion Policy
                                       Appendix 11
                     Guidelines on the Compatibility of Blood Products



Contents

1.0    Introduction
2.0    Aim and objectives
3.0    Scope
4.0    ABO Compatibility in relation to blood products
4.1    Red Cells
4.2    Fresh Frozen Plasma (FFP)
4.3    Platelets
4.4    Cryoprecipitate
5.0    Rh D status in relation to blood products
5.1    Red Cells and Platelets
5.2    Fresh Frozen Plasma (FFP) and cryoprecipitate




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 87 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
                                    Transfusion Policy
                                       Appendix 11
                     Guidelines on the Compatibility of Blood Products

1.0 Introduction
Understanding the basic principles of blood groups is fundamental to transfusion safety.

ABO groups are of paramount importance, as they are associated with potent antibodies
which may cause red cell haemolysis, leading to D.I.C. renal failure and death.

Rh D type is important as this blood group is extremely immunogenic. It has been shown
that 80% of Rh D negative people receiving a transfusion of Rh D positive cells will produce
anti D antibodies. This is particularly crucial when transfusing women still capable of child
bearing.

2.0 Aim and objectives
To avoid the inappropriate transfusion of ABO and Rh mismatched blood products.

3.0 Scope
All staff involved in the transfusion process.

4.0 ABO Compatibility in relation to blood products
4.1 Red Cells

Blood Group                Can receive
O                          O
A                          A and O
B                          B and O
AB                         AB,A,B and O

4.2 Fresh Frozen Plasma (FFP)
Blood Group           Can receive
O                     O, A or B
A                     A or AB
B                     B or AB
AB                    AB

Be aware, that F.F.P. intended for neonates is often supplied as a group AB product.

4.3 Platelets
Please note that generally, group AB is not available. Group B is rarely available.

Blood Group                Can receive
O                          O,A or B
A                          A, if necessary B or O
B                          B, if necessary A or O
AB                             if necessary B,A or O

        “major incompatibility”
Same group platelets are the product of choice. ABO antigens are present on platelets in low
density (5% of that on red cells). Transfusing ABO incompatible platelets may reduce
platelet survival.



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Hospital Transfusion Committee                             Page 88 of 225
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Ref: PCD 032(v1)                                                   Status : Operational
        “minor incompatibility”
Platelets products are plasma rich. Where the transfused product is of a different group,
“High titre” negative products will be provided, (Product labelled as “NEG: HT) to prevent
haemolysis of recipient’s red cells. Complications are rare, but clinicians should be aware of
the risks of transfusing large volumes of group O plasma rich products to non-Group O
patients.

This is particularly relevant when transfusing neonates and children 4 years or less.

4.4 Cryoprecipitate
Please note that generally group B and AB products are not available.

Blood Group              Can receive
O                        O
A                        A
B                        O
AB                       A

Where the transfused product is of a different group, “High titre” negative products will be
provided.

5.0 Rh D status in relation to blood products
5.1 Red Cells and Platelets
Rh D type                               Can receive
Rh D NEG females who are pre-           Rh D NEG only
menopausal
All Rh D POS patients and Rh D NEG          Can receive either Rh D POS or
males or post-menopausal females            Rh D NEG products
All Rh D NEG men and females who            When there are severe
are post-menopausal                         shortages of blood products
                                            these patient may need to be
                                            transfused Rh D POS products.
                                            But ensure the lab staff have
                                            confirmed this prior to
                                            transfusion.

Rh antigens are not expressed on platelets, therefore compatibly has no effect on the
survival for transfused platelets. BUT:

Residual red cells in the platelet products have been shown to immunize Rh D Negative
recipients of Rh D positive transfusion. (< 20% of transfusions)

If lack of availability dictates that Rh D positive platelets are given to a Rh D negative pre-
menopausal woman, then 250iu of anti-D should be administered to prevent



antibody sensitisation (which may be given subcutaneously in thrombocytopenic patients).
This will cover 3 adult therapeutic doses of platelets in a 6 week period.

5.2 Fresh Frozen Plasma (FFP) and cryoprecipitate

The revised FFP guidelines indicate that FFP can be given regardless of RhD group.
Therefore either Rh D Positive or Rh D Negative products can be transfused to all patients.
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Hospital Transfusion Committee                             Page 89 of 225
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Ref: PCD 032(v1)                                       Status : Operational




                   Transfusion Policy
                      Appendix 12
                 Guidelines for the use of
                     Red Blood Cells

                     Date: November 2005

                     Ref : PCD 0032 – A12

                     Vers : 0

      Policy Profile
      Policy Reference Number     PCD 032-A12
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 90 of 225
Transfusion Policy                                           November 2005
Ref: PCD 032(v1)                                         Status : Operational



                                Transfusion Policy
                                    Appendix 12
                     Guidelines for the Use Of Red Blood Cells


Contents


1.0    Introduction
2.0    Aims And Objectives
3.0    Scope
4.0    Consent
5.0    Risk
6.0    Prescribing / Ordering Red Cell Products
7.0    Administration
8.0    Indications and Recommendations
8.1    How Much To Transfuse – Guide To Reaching Transfusion Target
8.2    Acute Blood Loss
8.3    Massive Obstetric Haemorrhage
8.3    Massive Haemorrhage In A&E And Theatre
8.4    Anaemia in Patients Who Are Otherwise Stable And Well.
8.4.1 Chronic Anaemia
8.4.1 Iron Deficiency:
8.4.2 Megaloblastic Anaemia:
8.4.3 Anaemia of Chronic Disorder:
8.4.4 Anaemia of Chronic Renal Failure:
8.4.5 Primary Bone Marrow Disorders/Cytotoxic Marrow Impairment:
8.4.6 Autoimmune Haemolytic Anaemia
8.5    Post-Chemotherapy.
8.6    Post-Radiotherapy.
8.7    Critical Care
8.7.1 Patient To Be Transferred For Angiogram/ Angioplasty
8.8    The Elderly
8.9    Anaemia Due To Hereditary Conditions.
8.9.1 β-Thalassaemia
8.9.2 Sickle Cell Disease
8.10 Erythropoietin
9.0    Neonatal and Paediatric Transfusion.
10.1 Pre-Operative Assessment and/or Transfusion
10.2 Perioperative Transfusion
10.3 Haemorrhage During Surgery
10.3.1 Factors Influencing This Indication
10.4 Post Operative Blood Transfusion
11.0 Conclusion




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Hospital Transfusion Committee                             Page 91 of 225
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                                 Transfusion Policy
                                     Appendix 12
                      Guidelines for the Use Of Red Blood Cells

1.0 Introduction
Concerns about the safety of transfusion, in relation to both infectious and non-infectious
complications, the risk of transmission of Creutzfeldt-Jakob disease and the increasing
complexity and cost of the production of blood components show the need for sensible
guidelines for the use of red cells

2.0 Aims and Objectives
The only true indication for the transfusion of red cells is the need to improve the delivery of
oxygen to the tissues within a short time.
The purpose of this document is to set ‘pragmatic’ guidelines for the use of red cell
transfusions, to improve transfusion practice within the Trust and to provide a benchmark for
clinical audit. These guidelines have been based on the British Committee of Standard in
Haematology (BCSH) ‘Guidelines for the Clinical Use of Red Cell Transfusions.

3.0 Scope
This document is aimed at all heath care workers involved in the administration of red blood
cells.

4.0 Consent
See appendix 4

5.0 Risk
There are many risks associated with red blood cell transfusion. This must be considered
before making the decision to transfuse.

6.0 Prescribing / Ordering Red Cell Products
See Appendix 6

7.0 Administration
See Appendix 24.

8.0 Indications and Recommendations
8.1 How much to Transfuse – Guide to reaching Transfusion Target
When considering a transfusion, the target haemoglobin needs to be established and
recorded. The amount of red cells to be transfused will depend on patient size.

Amount of Haemoglobin in a unit of red cells = approx 60g
Blood volume (70ml/kg in adults)           50kg (3.5)L 60kg (4.2L)         70kg (4.9L)
Increase in Hb after 1 unit transfusion    1.7g/dl        1.4g/dl          1.2g/dl

8.2 Acute Blood Loss
The objective is to maintain circulating blood volume and a haemoglobin concentration
>7g/dl in otherwise fit patients, and >9g/dl in older patients and those with known
cardiovascular disease.

•   15% loss of blood volume (750mls in an adult), there is no need for transfusion.
•   15-30% loss of blood volume (800-1500mls in an adult), transfuse crystalloids or
    synthetic colloids. Red cells are unlikely to be required.


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•   30-40% loss of blood volume (1500-2000mls in an adult), rapid volume replacement is
    required with crystalloids and colloids and red cell transfusion will probably be required.
•   40% loss of blood volume (>2000mls in an adult), rapid blood volume replacement,
    including red cell transfusion, is required.

8.3 Massive Obstetric Haemorrhage
please refer to Adagio Policy 22

8.3 Massive Haemorrhage in A&E and Theatre
See appendix 13 Guideline for the management of massive transfusion.

8.4 Anaemia in patients who are otherwise stable and well.
The following guidelines should be considered.

•   Hb <4g/dl          Transfusion necessary.
•   Hb 4-7g/dl         Transfusion usually necessary, unless fit and Hb is rising.
•   Hb 7-10g/dl        Transfusion not usually necessary.
•   Hb >10g/dl         Transfusion rarely required.

Patients who are symptomatic or have co-existent cardiovascular or respiratory disease may
require higher thresholds.

            8.4.1 Chronic Anaemia
No evidence exists for increased measurable morbidity as long as haemoglobin levels are
kept above 7g/dl, however patients may feel better when haemoglobin levels is maintained
at a higher level and in chronic anaemia this may be relevant in terms of quality of life. Red
cell transfusions for patients with chronic anaemia should be given at intervals to maintain
the haemoglobin just above the lowest concentration that is not associated with symptoms of
anaemia.

           8.4.1 Iron deficiency:
These patients should not be transfused unless they need an immediate operation.
Investigate to establish the cause e.g. – chronic blood loss, malabsorption etc. and treat
appropriately, together with full iron therapy.
Ferrous sulphate 200mg tds for 3 months; should raise the Hb by about 1g/dl/week, in the
absence of other disease.
           8.4.2 Megaloblastic anaemia:
Transfusion should be avoided in these patients as it can precipitate cardiac failure. The
patient should be treated with the correct haematinic.
           8.4.3 Anaemia of chronic disorder:
This is the most common cause of anaemia in hospital patients. Usually patients run an Hb
8.0-10.0g/dl, depending on the activity of the underlying disease process.
It will improve if the primary disorder responds to treatment. Occasionally for surgery,
transfusion may be indicated.
           8.4.4 Anaemia of chronic renal failure:
This is now primarily treated with erythropoietin.
           8.4.5 Primary bone marrow disorders/cytotoxic marrow impairment:
These patients may require not only red cells, but also other blood components.
           8.4.6 Autoimmune haemolytic anaemia
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Hospital Transfusion Committee                             Page 93 of 225
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Do not transfuse unless the anaemia is life threatening.

8.5 Post-Chemotherapy.
Transfuse to maintain Hb >9g/dl

8.6 Post-Radiotherapy.
Transfuse to maintain Hb >10g/dl

8.7 Critical Care
Transfuse to maintain the Hb >7g/dl.

The concentration of haemoglobin should be considered along with all the other factors.

It is important to maintain blood pressure, normal cardiac output and adequate volume
replacement.

Red cell transfusion is not indicated when estimates of actual and anticipated haemoglobin
concentrations are >10g/dl.

Red cell transfusion is indicated when the haemoglobin concentration is <7 g/dl during or
after acute haemorrhage with red cells being given in relation to the rate of ongoing red cell
loss.

Over-transfusion may increase mortality in this group.

Mortality has been shown to be no worse in groups receiving a ‘restrictive’ transfusion
strategy (aiming at an Hb >7g/dl) than in patients receiving a liberal transfusion strategy
(aiming at an Hb >10g/dl ).

Transfusions to higher haemoglobin levels increase the risk of thrombotic complications.


            8.7.1 Patient to be transferred for Angiogram/ Angioplasty
Patients to be transferred to St Thomas’ for the above may be required to be transfused to
Hb 12g/dl.

8.8 The elderly
Some of these patients may require a target of 11g/dl

8.9 Anaemia due to hereditary conditions.
These adult patients are usually under the care of the Haematologist, however they may be admitted
for other reasons and it is important to ensure appropriate care is taken.

           8.9.1 β-thalassaemia
The aim is to maintain haemoglobin of greater or equal to 9g/dl, with the haemoglobin being
no more than 9.5g/dl before transfusion. This strategy provides adequate bone marrow
suppression and lower rates of iron overload.

As there is an additional risk of iron overload, use Iron chelation therapy.

They will require selected blood products.

Also See Appendix 26 Neonatal transfusion Policy.


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Hospital Transfusion Committee                             Page 94 of 225
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            8.9.2 Sickle Cell Disease
These patients will require selected blood.

Transfusions are not given routinely, but for specific indications:

    •   Splenic or hepatic sequestration
    •   Aplastic crisis

The aim is to raise the patient Hb to their normal steady state. Do not raise the Hb acutely to
>10g/dl.

Each adult sickle patient under the care of the D.V.H. Haematologist has their own individual
transfusion strategy. It is important to contact the Haematologist when a patient is admitted.

8.10 Erythropoietin
Erythropoietin has been used for treating chronic anaemia in patients with cancer, myeloma,
myelodysplasia and non-Hodgkin’s lymphoma. It is safe and effective in increasing
haemoglobin concentrations and produces a sustained increase in the haemoglobin
concentration rather than the fluctuating concentrations associated with regular transfusion.

9.0 Neonatal And Paediatric Transfusion.
See Appendix 26

10.0 Surgical Patients
10.1 Pre-operative Assessment and/or transfusion
Pre operative assessment should be in made in time to identify and treat anaemias. Where
possible one should aim for a pre operative Haemoglobin level of >10g/dl.
It is usually safer to correct anaemia with the appropriate haematinic if its cause is known.

Bleeding will be reduced if anti-platelet drugs are discontinued at least one week, and
anticoagulation therapy withheld or reversed, prior to the procedure.

Ordering of red cell concentrates for surgical procedures should be in line with the Trusts
Maximum Surgical Blood Ordering Schedule (MSBOS), See appendix 7.

In a normovolaemic patient consider transfusion if:
•   Hb concentration below 7g/dl.
•   Hb concentration below 9 g/dl in a patient with known cardiovascular disease, or those
    with significant risk factors for cardiovascular disease (e.g. elderly patients, and those
    with hypertension , diabetes mellitus, peripheral vascular disease).

10.2 Perioperative Transfusion
Beware - Perioperative transfusion may be associated with an increased risk of
postoperative bacterial infection.

10.3 Haemorrhage during surgery
The same approach to the management of acute haemorrhage during surgery should be
applied as for acute blood loss. See Appendix 13.

There is no need to transfuse back to a ‘normal’ level during or after surgery and transfusion
should be avoided when the measured or anticipated haemoglobin concentration is >10g/dl.

During and following surgery, oxygen supply and demand will be improved by ensuring
optimal volume status, providing adequate analgesia, supplemental oxygen and by
maintaining normothermia.
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Hospital Transfusion Committee                             Page 95 of 225
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               10.3.1 Factors influencing this indication:
•   Patient’s age – young patients can tolerate chronic and even acute anaemia well,
    provided the circulating volume is maintained; elderly patients will be more prone to
    cardiac ischaemia.
•   Volume and rate of blood loss – acute blood loss of >20% will require both fluid and
    red cell replacement.

10.4 Post operative blood transfusion
Post –operative transfusion is only indicated for symptomatic anaemia- there is no evidence
that a higher Hb speeds the rate of recovery from surgery.
A transfusion should never be given to allow a patient to be discharged home earlier than
otherwise. In many patients iron supplements provide an adequate and safer alternative.

11.0 Conclusion
Transfusion above 10g/dl is rarely indicated.

Think before transfusing. Blood is potentially dangerous if used inappropriately & is
increasingly expensive.

Re-assess after each unit is given.
          Stop if symptoms / signs resolve.
          Stop when adequate Hb is achieved.




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Hospital Transfusion Committee                             Page 96 of 225
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Ref: PCD 032(v1)                                       Status : Operational




         Transfusion Policy
             Appendix 13
Guidelines for Management of Massive
              Transfusion


                     Date: November 2005

                     Ref : PCD 032 – A13

                     Vers : 1

      Policy Profile
      Policy Reference Number     PCD 032-13
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 97 of 225
Transfusion Policy                                                November 2005
Ref: PCD 032(v1)                                              Status : Operational

                                   Transfusion Policy
                                      Appendix 13
              Guidelines for the Management of Massive Blood Transfusion



Contents


1.0    Introduction
2.0    Definition.
3.0    Aims
4.0    Initial Management.
5.0    Inform the Pathology Department.
5.1    Advice related to Pathology
6.0    Estimate lost circulating volume
7.0    Determine blood product requirements, with consideration of Pathology result.
7.1    Haemoglobin.
7.2    Coagulopathy.
8.0    Ordering blood products.
9.0    Availability of blood products.
10.0   Pharmacological adjuncts
11.0   Emergency Issue of Blood
12.0   Collecting blood products
13.0   Correct control of blood products.
14.0   Administration of blood product.
15.0   Continuation of Transfusion.
16.0   Continued uncontrolled haemorrhage
17.0   Obstetric emergencies
18.0   Communication
19.0   End point
20.0   Appendix - Classification of hypovolaemic shock according to blood loss (Baskett,
       1990)




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Hospital Transfusion Committee                             Page 98 of 225
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Ref: PCD 032(v1)                                                Status : Operational
                                   Transfusion Policy
                                      Appendix 13
              Guidelines for the Management of Massive Blood Transfusion

1.0 Introduction
Massive blood loss presents a serious threat to patient survival. Most practical problems
occur when large volume blood loss occurs suddenly and unexpectedly. Such situations
often create extreme tensions between those attempting to treat the haemorrhage and the
staff supplying the blood or blood components. Poor communication can result in errors and
inappropriate actions being taken or untimely provision of products.

2.0 Definition.
Massive blood loss is arbitrarily defined as:
    • When transfusion of more than one whole blood volume in less than 24 hours is
       required. (In adult the estimated volume is 70mls/Kg, equivalent to 8-10 units of
       blood).
    • Loss of more than 40% (50%) loss of blood volume within 3 hours.
    • A rate of loss is > 150 mls/min.

For clinical features see: Classification of hypovolaemic shock; at end of this
document.

3.0 Aims of patient management.
    • To restore and maintain circulating fluid volume
    • To maintain adequate blood oxygen transport capacity- maintain PCV >20%
    • To maintain haemostasis – platelets >50x109/l, or > 100x109/l if danger of intracranial
       bleeding.
           o achieve surgical control of bleeding, where applicable.
           o Correct any coagulopathy.

4.0 Initial Management.
    • Give oxygen
    • Gain i.v. good access. – use wide bore peripheral cannula.
    • Keep the patient warm.
    • Restore circulating volume;
            o Correct the blood volume with fluids.
            o Aim to maintain normal pressure and urine output >30 ml/h
            o It is preferable to use warmed fluid.
            o Usually the fluid replacement would be a combination of crystalloids (such as
               0.9% Sodium Chloride solution or “Hartmann’s” solution) and colloids (such
               as gelofusine or hetastarch).
    • Contact key personnel.
            o Clinician in charge.
            o Duty anaesthetist.
            o Critical Care SHO.
            o Laboratory staff.
            o Surgical on-call team.

   •   Arrest Bleeding.
           o Direct pressure.
           o Early Surgical or Obstetric Intervention.
           o Interventional radiology.
   •   Request laboratory investigations.
           o FBC, PT, APTT, fibrinogen;
           o blood-bank sample,
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          o biochemical profile,
          o blood gases or pulse oximetry.
       Ensure correct sample identity. Repeat FBC, PT, APTT fibrinogen every 4 hr or after
       one blood volume replacement [approx equivalent to 2 L blood loss]
          • Repeat requests after blood component infusion.

   •   Request suitable red cells.
          o Uncrossmatched group 0 Rh negative (2 units) only in extreme emergency.
          o Uncrossmatched ABO group-specific - when blood group known.
          o Fully cross-matched.
                 • If irregular antibodies present you will be advised as to availability by
                     laboratory staff.

5.0 Inform the Pathology Department.
    • Contact Haematology/Blood Bank or On Call BMS ASAP and inform them that there
        is an emergency.
   •   Blood transfusion – send 6ml sample pink top EDTA for Group and Save.
   •   Haematology – send 4ml purple top EDTA sample for Hb/pcv and platelets.
                      send 4 ml blue top sodium citrate sample for clotting screen.
   •   Biochemistry – send 7ml Orange top sample for urea and electrolytes (baseline).

    5.1 Advice related to Pathology
Where there is advanced warning of a major trauma arriving in A/E, inform the transfusion laboratory
/ haematology, particularly during out of hours.
       • Correctly label samples to avoid requests for repeat samples.
       •   Fill the requests correctly and mark them URGENT.
       •   Ensure that the sample and request form are delivered rapidly to the laboratory.
       •   Nominate a single person to liaise with pathology.
               o     Keep calls to the laboratory to a minimum as frequent unnecessary calls
                     will delay the provision of compatible blood.
       •   State clearly, reason for request, clinical situation and urgency, number and type
           of blood product required, special requirements (e.g. irradiated), and time
           required - in minutes.
   The laboratory staff will telephone as soon as the blood for urgent crossmatches is available.
   Make sure your request states where the patient is located

6.0 Estimate lost circulating volume
It may be difficult to assess the amount of blood loss, but consideration of lost circulating
volume may be useful in guiding transfusion management.

Unless compensating for pre-existing anaemia, cardiovascular or respiratory disease use the
following guidelines.




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Hospital Transfusion Committee                             Page 100 of 225
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                 BLOOD LOSS                                   TREATMENT
    15% loss of blood volume (750mls in an       There is no need for transfusion.
    adult)
    15-30% loss of blood volume (500-            replace blood volume with crystalloids or
    1500mls in an adult)                         synthetic colloids, there is no need for
                                                 red cell transfusion
    30-40% loss of blood volume (1500-           rapid volume replacement is required
    2000mls in an adult)                         with crystalloids and colloids and red cell
                                                 transfusion will probably be required
    > 40% loss of blood volume (>2000mls         rapid blood volume replacement,
    in an adult)                                 including red cell transfusion, is required

7.0 Determine blood product requirements, with consideration of Pathology result.
Dilutional effect of blood loss and development of consumptive coagulopathy, particularly in
major trauma or obstetric haemorrhage are difficult to determine. Look at the pathology
results. Send regular blood samples.

        7.1 Haemoglobin.
Set your target Hb. Generally this will be above 7g/dl and below 9gm/dl.
In the absence of bleeding, 1 unit of blood will raise an adult Hb approx. 1g/dl.

       7.2 Coagulopathy.
Standardised formulae for platelets and FFP replacement are not of value. Blood products
replacement should be given according to clinical status and the results of laboratory tests
and not prophylactically.

The decision to correct coagulation abnormalities should normally be taken by the doctor
managing the case in discussion with the Consultant Haematologist.

INR <1.5 and/or APPTR < 1.5 order F.F.P. at 15ml/ 1Kg body weight.
Fibrinogen level < 1gm order 10 units cryoprecipitate.

Platelet count < 50x109/l order platelets or <100x109/l where there is microvascular bleeding.
In the absence of bleeding I dose platelets will raise an adult platelet count approx 40x109/l

8.0 Ordering blood products.
Explain the clinical condition of the patient and state the product(s) and number of units
required. State the urgency (giving time in minutes):

9.0 Availability of blood products.
RBC O Rh (D) Negative Emergency Issue
(Flying Squad) Units.                                available immediately
RBC ABO and Rh (D) Compatible Units.                 10 minutes
RBC Fully Compatible Blood.                          40 minutes

F.F.P.                                               40 minutes
CRYOPRECIPITATE                                      40 minutes

PLATELETS                                            2-3 HOURS

10.0 Pharmacological adjuncts
i.v. Calcium Chloride     May be required if patient has liver disease and cannot
                          metabolise citrate in the blood


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Hospital Transfusion Committee                             Page 101 of 225
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11.0 Emergency Issue of Blood
Blood will be issued according to the degree of urgency indicated.

If uncross-matched blood is being issued, the porter bringing samples to pathology should
be instructed to wait at the blood bank and return with the group specific blood.

Where blood is requested urgently the blood bank staff will telephone the requesting clinician
to inform them when the blood is ready. This is dependent on the presence of adequate and
legible contact details on the request form.

12.0 Collecting blood products
See Appendix 22 Collection and Delivery of Blood for transfusion.

Blood must be collected by staff that have received training and are aware of the correct
procedure.

13.0 Correct control of blood products.
It is important, to prevent wastage and risk of bacterial contamination, that blood products
are maintained under controlled conditions.

Blood should not be checked in batches.
Blood should not be kept out of the blood refrigerator awaiting transfusion
If it is clear that units of blood will not be required for a patient, for example if the patient
dies, blood bank should be informed in order to reclaim the unused blood.
Do not put warm blood, which has been un-refrigerated for more than 30 minutes, back into
cold storage, where there is risk of it being used on a later occasion.

14.0 Administration of blood product.
Follow usual procedures. See Appendix 24

Where blood is being administered in large volumes, at a flow rate of >50ml/kg/hr it should
be administered via a blood warmer to prevent the effects of hypothermia.

15.0 Continuation of Transfusion.
While the haemorrhage and transfusion is ongoing, blood should be ordered in batches of 10
units.

After 8 units of blood (1 adult blood volume), has been transfused within 24 hours, group
specific blood (uncrossmatched) will be issued.

Once 8 units of blood have been requested to be cross-matched the Consultant
Haematologist will be informed of the situation by the blood bank staff in order to assist the
clinicians with management of the transfusion and to direct management of stocks of blood
and blood components.

16.0 Continued uncontrolled haemorrhage
If uncontrolled haemorrhage continues, especially in multi-trauma setting, consider use of
recombinant activated factor VII (rFVIIa). This may be suitable for blunt trauma and may not
be suitable for penetrative trauma.

   • Discuss with Consultant Haematologist on-call.
   • Initial dose 120 micrograms/kg - 2.4g & 4.8g vials available.
   • Second dose, 60 -90 micrograms/kg if haemostasis not achieved in 20 minutes.

See Appendix 19 Use of rFVIIa

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Hospital Transfusion Committee                             Page 102 of 225
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Ref: PCD 032(v1)                                                 Status : Operational
17.0 Obstetric emergencies
Also see Trust Policies on Adagio
   • Management of Antepartum and Postpartum Haemorrhage
   • Management of Retained Placenta.

18.0 Communication
Keep the laboratory informed of the patient’s progress so they can continue to anticipate
further requirements from the National Blood Service and also terminate work if the patient
dies.

19.0 End point
Maintain urine output>0.5ml/kg/hr & systolic BP>100mmHg
Maintain Hb >9g/dl

20.0 Appendix - Classification of hypovolaemic shock according to blood loss
(Baskett, 1990)

                     CLASS I         CLASS II        CLASS III             CLASS IV
Blood loss
     % volume: <15%                  15-30%          30-40%                >40%
           ml: 750ml                 800-1500ml      1500-2000ml           >2000ml

Blood pressure
       Systolic:
      Diastolic: Unchanged           Normal          Reduced               Very low
                 Unchanged           Raised          Reduced               Unrecordable

Pulse                Slight          100-120         120 (thready)         >120 (very
      Beats / min:   tachicardia                                           thready)
Capillary refill:    Normal          Slow (>2s)      Slow (>2s)            Undetectable
Respiratory          Normal          Normal          Tachypnoea            Tachypnoea
rate:                                                (>20/min)             (>20/min)
Urinary flow
rate ml/hr:          >30             20-30           10-20                 0-10
Extremities:         Colour normal   Pale            Pale                  Pale and cold
Complexion:          Normal          Pale            Pale                  Ashen
Mental state:        Alert           Anxious or      Anxious or            Drowsy, confused
                                     aggressive      aggressive or         or unconscious
                                                     drowsy




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Hospital Transfusion Committee                             Page 103 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




         Transfusion Policy
             Appendix 14
       Guidelines for the use of
O Rh D Negative Blood in an Emergency

                     Date: November 2005

                     Ref : PCD 032 – A14

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032-A14
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          September 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 104 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational



                               Transfusion Policy
                                  Appendix 14
         Guidelines for the Use O Rh D Negative Blood in an Emergency



CONTENT

1.0         Introduction
2.0         Aims and objectives
3.0         Scope
4.0         Associated policies
5.0         Indication
6.0         Patient Management
7.0          Requesting
7.1    Considerations prior to requesting
8.0         Patient sample
9.0         Paediatric Patients
10.0        Collection
11.0        Returning Un-Used Product
12.0   Documentation
13.0   Flow Chart




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 105 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational
                                Transfusion Policy
                                   Appendix 14
          Guidelines for the Use O Rh D Negative Blood in an Emergency

1.0 Introduction
Emergency issue of O Rh DNegative Blood is available for life threatening emergency use at any
time, 24 hours a day. Two units are kept in The Pathology Blood Transfusion Department.

2.0 Aims and objectives
To ensure blood is available to patients when necessary and to ensure the appropriate use of a
scarce resource.

3.0 Scope
All staff involve in the transfusion process.

4.0 Associated policies
This guideline is distilled from.

    •   Trust Transfusion Policy
    •   Guidelines for Massive Transfusion
    •   Requesting Blood Products

5.0 Indication
An emergency, where there is insufficient time for the blood bank to issue “same group” blood.

6.0 Patient Management
If your patient is actively bleeding:
     • Restore circulating volume with crystalloid
            o Aim to maintain normal BP (systolic BP > 100) and urine output > 30 ml/hr
                 (adults)
            o NB in patients with major vessel or cardiac injury, fluid resuscitation may need
                 to be restricted – discuss with surgical team
     • Red blood cell transfusion is likely to be necessary if > 30% blood volume (about
        1500 ml in an adult) has been lost, and the patient is still bleeding, to maintain
        oxygenation

Contact Blood Bank ASAP
Send properly labeled samples for crossmatch, FBC and clotting ASAP (results may be
affected by large volume fluid infusion)

7.0 Requesting
Remember, there are risks associated with transfusing uncross matched O Negative blood. Where
the patient’s blood group is known and confirmed, it is safer to transfuse ABO Rh (D) compatible
blood.

Fully cross-matched blood can be available within 40 minutes once the sample has arrived
in Blood Bank.

Same group blood can be available within 10 minutes once the sample has arrived in blood
bank.

7.1 Considerations prior to requesting
    • Is blood needed immediately, i.e. profuse active bleeding and Hb <7.0?
    • (For older patients and those with cardiovascular disease Hb <9.0)

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Hospital Transfusion Committee                             Page 106 of 225
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   •   How long will it take to obtain fully cross-matched blood? If > 20 minutes then O Neg
       can be given while the patient’s blood group is being established.
   •   Blood grouping should be carried out as quickly as possible to minimise the ‘blind’
       use of O Negative – this can be limited to two units in most instances.
   •   Once the patient’s blood group has been established, group specific blood can be
       used.

N.B. See Flow Chart at the end of this document.

8.0 Patient sample
A specimen must be taken from the patient prior to the infusion of these units.

9.0 Paediatric Patients
NEVER use Emergency Issue (flying squad blood) for paediatric and neonatal patients. Neonatal
blood products have many special requirements.

 Please seek the assistance of the Biomedical Scientist at the Blood Bank in all emergency situation
involving paediatric and neonatal patients.

Pediatric packs for top-up are available. These are not a large enough for exchange transfusion.

10.0 Collection
The collection procedure is the same as any other products removed from the blood fridge.
To obtain this product, telephone the blood bank on extension 8502, or, out of hours, contact the
BMS On-Call (via switchboard) as soon as possible.

Inform the laboratory staff of the name and hospital number of the patient.

Send someone directly to the blood bank to collect the product.

The units must not be taken without the knowledge of the Blood Transfusion Department as
they must arrange replacement.

11.0 Returning Un-Used Product
Should circumstances change, and this blood is no longer required, please ensure that it is
returned to the blood bank within thirty minutes to prevent wastage.

12.0 Documentation
The form accompanying a flying squad, blood unit, must be completed and returned with the
empty bag to the Blood Transfusion Department immediately after use. This will allow the
transfusion department to:

   •   Print report with the recipient name and given blood distinctive detail, for permanent
       filing in the patients notes. The document will be forwarded back to the ward /
       department immediately.
   •   Update Transfusion Computer system.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 107 of 225
    Transfusion Policy                                                     November 2005
    Ref: PCD 032(v1)                                                   Status : Operational
           THE USE OF O NEGATIVE BLOOD IN AN EMERGENCY SITUATION

     Is Patient Bleeding                        Yes                                  Major vessel or cardiac injury?
     profusely?

                                                                                             No                  Yes


                           Contact Blood Ba            Restore circulating
                           ASAP                          volume with                              Fluid     resuscitation
                                                           crystalloid                            may need to be
                                                                                                  restricted.    Discuss
                                                                                                  with surgeons
   Send samples
  for crossmatch,                                     Has there been a
      FBC and                                         response to fluids?                                  Yes
  clotting screen
       ASAP

                                                                 No

                                                                                              Aim to maintain norm
Group specific blood                                 Is the patient experiencing              (SBP >100) and urin
can be available in 10                              class lll or lV shock? (Blood             output (> 30 ml/hr in
  minutes, once the                                   loss > 1500 ml, HR >120,                )
 sample has reached                                   Decreased SBP, RR > 30)
     Blood Bank                                     Consider occult bleeding also.




                                                    Yes                      No                        Continue to
                                                                                                       observe and
                                                                                                       monitor closely
                                              Is patient still                    No
   Cross-matched                                 bleeding
    blood can be                                profusely?
 available within 40
  minutes, once the
 sample has arrived                           Yes
   in Blood Bank
                                          Is Hb < 7.0?                                 No
                                          (older patients <9.0?)

    Use cross-matched                                     Yes                                Consider giving O Neg
     blood as soon as                                                                       RBCs - Two units always
                                          Is cross-matched blood ava
    available, minimise                                                                            available
                                Yes       yet?                                No
   ‘blind’ use of O Neg


    __________________________________________________________________________
    Dartford and Gravesham NHS Trust
    Hospital Transfusion Committee                             Page 108 of 225
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Ref: PCD 032(v1)                                       Status : Operational




              Transfusion Policy
                 Appendix 15
         Autologous Blood Transfusion



                     Date: November 2005

                     Ref : PCD 032 – A15

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032-A15
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 109 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




                               Transfusion Policy
                                  Appendix 15
                         Autologous Blood Transfusion


Contents

1.0    Introduction.
2.0    Aims and Objectives
3.0    Scope
4.0    Surgical setting
4.1    Autologous Pre-Deposit (PAD)
4.2    Acute Normovolaemic Haemodilution (ANH)
4.3    Intra-Operative Cell Salvage.
4.4    Post Operative Cell Salvage




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 110 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
                                   Transfusion Policy
                                      Appendix 15
                             Autologous Blood Transfusion

1.0 Introduction.
Autologous blood transfusions are more commonly associated with the surgical setting. The
consideration of the use of autologous blood is a requirement of Health Service Circular
HSC 2002/009 (known as better blood transfusion 2); - appropriate use of blood, and the
“Emergency blood plan” to reduce routine use of blood
However autologous transfusion, as with homologous transfusion, is not without risk, and
should be undertaken with careful consideration and adherence to guidelines.

2.0 Aims and Objectives
To reduced the Trusts’ reliance on donor blood, which is a diminishing and expensive
commodity. For our patient’s it would prevent transmission of blood borne infections, reduce
the immunological effects of transfusion and reduced risk of alloimmunisation.

3.0 Scope
All involved in the transfusion process, particularly those involved in surgery and surgical
pre-assessment and those who care for medical patient for whom pharmaceutical
alternatives to blood might be considered.

4.0 Surgical setting
The options are:

   •   Collect blood from the patient before the operation:
           o Pre- deposit Autologous Donation (PAD)
           o Acute Normovolaemic Haemodilution –see appendix 26.
   •   Collect blood from the patient during the operation:
           o Intra - operative cell salvage
           o Collect & re-infuse –e.g. Solcotrans
           o Collect wash re-infuse via cell savers – e.g. Haemonetics.
   •   Collect blood from the patient after the operation:
           o Post operative cell salvage – e.g. Bellovac.

4.1 Autologous Pre-Deposit (PAD)
PAD is a process whereby blood is collected from a patient, stored and re-transfused to the
patient during or immediately post surgery.

This is not a cost effective procedure and is now out of vogue.

The procedure must be carried out on a licensed premises, which Darent Valley is not.
There is no longer a routine Autologous pre-deposit service available through the National
Blood Service in Tooting. They reserve this for patients with rare or multiple antibodies for
whom donor blood is difficult to provide. In these cases the operation
date should be fixed an adequate time in advance to allow the arrangements to be made.
(about 4-6 weeks).

The patient should be well motivated to complete the collection program and be medically fit
and satisfy standard blood donation criteria.

4.2 Acute Normovolaemic Haemodilution (ANH)
 Acute Normovolaemic Haemodilution (ANH) is defined as the removal of blood from a
patient immediately before operation and simultaneous replacement with an appropriate
volume of crystalloid or colloid solution.
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Hospital Transfusion Committee                             Page 111 of 225
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The blood collected is re-infused to the patient, generally at the end of the operation, but
occasionally during the operation should the patient bleed.

See Appendix 26 for the agreed Acute Normovolaemic Haemodilution procedure

4.3 Intra-Operative Cell Salvage.
This is not currently undertaken at Darent Valley Hospital.

In this procedure blood shed during surgery is collected and re-infused to the patient,
reducing the requirement for donor blood.

4.4 Post Operative Cell Salvage
This is not currently undertaken at Darent Valley Hospital although its possible use is being
evaluated at this time.

Post operative cell salvage involves the collection, filtration and re-infusion of drained blood
into the patient following surgery.

   Indications
Orthopaedic procedures such as
• Total and revision hip replacement
• Total and revision knee replacement
• Spinal surgery
   Contra-indications
• Septic contamination of site or drained blood.
• Malignant lesions in the area of surgery
• Breast surgery
• Lack of appropriately trained staff.
   Risks
• Febrile reaction
• Air embolism
• Fat embolism
   Preparation of the patient
• A sample of blood should be sent for Group and Screen.
• When operative consent is sought the patient must be informed of the intention to use
    autologous and/or donated blood.
    Collection
Should the system be introduced a specific protocol will be written.
In general terms, blood will be collected and re-infused using such systems as the Bellovac®
ABT system.
The blood for re-infusion must be prescribed by a doctor (usually the anaesthetist).
The re-infusion should be complete within 6 hours of the start of collection.
Autologous blood collected in this will not be removed from the patient, stored or
refrigerated.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 112 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




                   Transfusion Policy
                      Appendix 16
                 Guidelines for the use of
                         Platelets


                     Date: November 2005

                     Ref : PCD 032 – A16

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032-A16
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 113 of 225
Transfusion Policy                                                November 2005
Ref: PCD 032(v1)                                              Status : Operational




                                 Transfusion Policy
                                    Appendix 16
                         Guidelines for the Use of Platelets


Contents

1.0    Objectives
2.0    Aims and Objectives
3.0    Scope
4.0    Consent
5.0    Risk
6.0    Prescribing / Ordering Platelet Products
7.0    Administration
8.0    Product Information
9.0    Dose
11.0   Contraindications to Platelet Transfusions
12.0   Minimizing the Use of Platelet Transfusions
13.0   Requesting and Ordering Platelets
14.0   Selection & Provision Of Platelet Products
15.0   Management Of Adverse Effects
16.0   Response to Platelet Transfusions
17.0   Platelet Refractoriness

Diagram 1:
Investigation and Management of Patient Refractoriness to Platelet Transfusion.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 114 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational

                                  Transfusion Policy
                                     Appendix 16
                          Guidelines for the Use of Platelets

1.0 Introduction
These guidelines are based on British Committee for Standards in Haematology (BCSH)
platelet transfusions July 2003. (British Journal of Haematology 122: 10–23)

The ready availability of platelet concentrates has made a major contribution to modern
clinical practice. However as the use of these expensive products continues to increase it is
important to give guidance about the use to medical, nursing and technical staff in hospitals
responsible for prescribing, administering and providing platelet transfusions.

2.0 Aims and Objectives
The purpose of this document is to give guidance on platelet transfusion therapy in order to
improve transfusion practice and to provide a benchmark for clinical audit.

3.0 Scope
This document is aimed at all heath care workers involved in the administration of platelets.

4.0 Consent
Patient Consent is required (See appendix 4). Please record this in the patients’ notes.

5.0 Risk
There is risk associated with platelet transfusion. This must be considered before making the
decision to Transfuse.

Decision to transfuse will also include an assessment of risk versus benefit.
Risks include:
   • Alloimmunization
   • allergic reactions
   • transfusion-related acute lung injury
   • transmission of infection
        Also, because platelets are stored at room temperature they are more often
        implicated in adverse events due to bacterial contamination than with other blood
        products.

6.0 Prescribing / Ordering Platelet Products
Prescribe and order the products. See appendix 6 and 8.

The cause of thrombocytopenia should be established before a decision of platelet
transfusion is made.
Potential benefits include:
    • reducing morbidity associated with minor haemorrhage
    • reducing morbidity ⁄ mortality resulting from major bleeding.

Platelets may be contra indicated, and even dangerous if given in some circumstances such
conditions as Thrombotic Thrombocytopenic Purpura (TTP) and Heparin-induced
thrombocytopenia (HIT). See Contra Indications below.

6.1 Special requirements
Record in the notes, and inform the blood bank of any special requirements such as
irradiated or CMV negative products.

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Hospital Transfusion Committee                             Page 115 of 225
Transfusion Policy                                                      November 2005
Ref: PCD 032(v1)                                                    Status : Operational
7.0 Administration
See transfusion policy appendix 23 (PCD 032-A23)

Blood bank staff will inspect platelet concentrates prior to issue, checking the integrity of the
pack, checking for leaks at the ports and the seams; and evidence of unusual colour or
turbidity or clumps, which might suggest bacterial contamination.

Staff administering the unit should check it in a similar way before its administration, and to
return it to the hospital blood bank if any abnormalities are found.

7.1 Duration of the transfusion
It is recommended that a platelet concentrate is administered over a 30 min period.
In the paediatric setting, this approximates to a rate of 20–30 ml ⁄ kg ⁄ h.

7.2 Giving sets ⁄ filters
Use a standard platelet administration set – provided by the blood bank with the unit.

Do not use a giving set that has been used for blood.

A screen filter is required for the giving of platelets via a syringe for neonatal or foetal
transfusion.

7.2 Monitoring during the transfusion
Inform the patient of possible complications of transfusion, and the importance of reporting
any adverse effects.

Follow the same baseline, 15 minute and post, observation checks as for red cell
transfusions.

8.0 Product Information
Platelet concentrates are prepared from either whole blood donations (a pool of 4), or by
plateletpheresis.

Platelet concentrate prepared from the buffy coats therefore result in higher donor exposure
than those form plateletpheresis.

Platelets are leucodepleted (by filtration).

Volume                  150–300 ml for platelet concentrates prepared by apheresis
Volume                  150– 450 ml for those prepared from whole blood.

Platelet count:         > 240 x 109 per adult dose.
pH:                     between 6.4 and 7.4 throughout the shelf-life.

Storage and shelf life 5 days, stored at 22oC ± 2oC with continual gentle agitation.
                       24 hours after suspension in PSM or washing.

Platelets meet standard requirements for donor selection and mandatory microbiological
testing.

8.1 Neonatal platelets
Components contain > 40 x 109 ⁄ l platelets.
Specifications additional to those listed above, Free of clinically significant irregular
antibodies, including high titre anti-A and anti-B and negative for cytomegalovirus.
See Neonatal Transfusion Policy appendix 26

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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 116 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
9.0 Dose - Calculation of dose of platelets

9.1 Adult dose
Usual dose is 1 adult pack.

An adult dose of platelets contains >240 x 109/l. The patient’s platelet count should increase
by at least 20 x 109/l (up to 50 x 109/l) and where the increment is persistently below this
figure, platelet refractoriness should be considered.

Rarely required, an estimate of the dose (in mls) may be calculated using the formula:

Dose (ml) = Desired Increment x Patients Blood Volume x 0.067

9.2 Paediatric dose
In neonates, where there is considerable danger of haemorrhage, platelet transfusion is
indicated at a higher platelet count than in adults.

Usual dose is 10-15ml/Kg body weight - up to 1 adult dose. e.g.

Children under 15 Kg require a 0.25 ADT pack. (labelled for neonatal use)
Children between 15 – 30 Kg require two 0.25 ADT packs from the same donor.
Children between 31 -39 Kg require three 0.25 ADT packs from the same donor
Children over 39 kg require 1 ADT pack.

10.0 Indications For Platelet Transfusions
Platelet transfusions are indicated for the prevention and treatment of haemorrhage in
patients with thrombocytopenia or platelet function defects. Platelet transfusions
are not indicated in all causes of thrombocytopenia and may indeed be contraindicated in
certain conditions.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 117 of 225
Transfusion Policy                                                 November 2005
Ref: PCD 032(v1)                                               Status : Operational


10.1 Indication in Brief



                           PROPHYLAXIS
Platelet Count x 109/L     Transfuse
Less than 10               Routinely
Less than 20               Temperature > 38o C
                           Minor bleeding
                           Mucocutaneous hamatomas not requiring red cell
                           transfusion
Less than 50               Coagulation disorder
                           Patient anticoagulated
                           Minor procedures
                           Lumber puncture
                           Bone Marrow
                           Major procedure
                           Central line
                           Biopsy
                           Major bleeding e.g. haematemesis
                           Massive transfusion > 1.5 times volume (70 – 80 ml/kg)

Less than 100              Neuro or spinal cord surgery aim for count > 100

                           ACTIVE BLEEDING
Less than 50               Platelet dysfunction – see Consultant Haematologist.
Less than 100              Multiple Trauma
                           Major Obstetric Haemorrhage



10.2 Indication in full

10.2.1 Acute leukaemia (excluding promyelocytic leukaemia)
Threshold for platelet transfusion:                        10 x 109/l.

10.2.2 Acute promyelocytic leukaemia
Patients who are haemorrhagic: Platelet count should be kept above 20 x 109/l.

10.2.3 Haemopoietic stem cell transplantation
Threshold for platelet transfusion is:                            10 x 109/l.

10.2.4 Chronic stable thrombocytopenia
e.g. some patients with myelodysplasia or aplastic anaemia:       10 x 109/l.

Long-term prophylactic platelet transfusions may be best avoided in these patients because
of the risk of alloimmunization and platelet refractoriness, and other complications of
transfusion.

Therapeutic platelet transfusions should be used to treat overt haemorrhage, and such
patients may require prophylactic platelet transfusions to prevent recurrent haemorrhage
during unstable periods associated with infection or active treatment.


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Hospital Transfusion Committee                             Page 118 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
Threshold of 10 x 109/l; Safe as higher levels for patients without additional risk factors.
Risk factors include sepsis, concurrent use of antibiotics or other abnormalities of
haemostasis.

A specific threshold for transfusion may not be appropriate for patients with chronic stable
thrombocytopenia who are best managed on an individual basis depending on the degree of
haemorrhage.

10.2.5 Prophylaxis for surgery and invasive procedures:

10.2.5.1 Bone marrow aspiration and biopsy may be performed in patients with severe
thrombocytopenia without platelet support, providing that adequate surface pressure is
applied.

10.2.5.2 For lumbar puncture, epidural anaesthesia, gastroscopy and biopsy, insertion
of indwelling lines, transbronchial biopsy, liver biopsy, laparotomy etc the platelet
count should be raised to at least 50 x 109/l

10.2.5.3 For operations in critical sites e.g. the brain or eyes, the platelet count should
be raised to 100 x 109/l

N.B Do not assume a post transfusion rise in platelet count. Perform a preoperative
platelet count to ensure thresholds have been reached.

10.2.6 Platelet function disorders
Patients with platelet function disorders rarely need platelet transfusions. However, acquired
causes of platelet dysfunction can exacerbate bleeding in patients who already have
impaired haemostasis.

For the management of bleeding or for prophylaxis before invasive procedures for patients
with a known or suspected platelet function disorder:
    • Withdraw drugs known to have anti-platelet activity.
    • Correct any underlying condition known to be associated with platelet dysfunction, if
        possible.
    • Correct the haematocrit to > 30 % in patients with renal failure, either with the use of
        recombinant erythropoietin or red cell transfusion.
    • Consider the use of DDAVP (desmopressin) in patients with inherited dysfunction
        defects, such as storage pool disease.
    • Consider the use of DDAVP or cryoprecipitate in patients with uraemia.
    • Use platelet transfusions where the above methods are not appropriate or are
        ineffective.
    • In Glanzmann’s thrombasthenia, the high likelihood of alloimmunization and
        subsequent platelet refractoriness should be taken into account. Consider the use of
        recombinant factor VIIa.

10.2.7 Massive transfusion – Indication for platelet transfusion:

        Acute bleeding:
Platelet count should not be allowed to fall below                   50 x 109/l
        Multiple trauma or central nervous system injury:
Recommended target level                                             100 x 109/l

10.2.8 Disseminated intravascular coagulation (DIC)

10.2.8.1 Acute DIC
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The first step would be to treat the underlying cause of DIC.

Platelet transfusions may be required where there is bleeding associated with
thrombocytopenia.

Ensure frequent platelet count and coagulation screening tests are carried out.

Aim to maintain the platelet count > 50 x 109/l.

10.2.8.3 Chronic DIC
In chronic DIC, or in the absence of bleeding, platelet transfusions should not be given
merely to correct a low platelet count.

10.2.9 Cardiopulmonary bypass
Not relevant at D.V.H.

10.2.10 Liver transplant surgery.
Not relevant at D.V.H.

10.2.11 Immune thrombocytopenias
       10.2.11.1       Autoimmune thrombocytopenia
Reserve Platelet transfusions for patients with life-threatening bleeding from the
gastrointestinal or genitourinary tracts into the central nervous system or other sites
associated with severe thrombocytopenia.

A large number of platelet concentrates may be required to achieve haemostasis as a result
of reduced survival of the transfused platelets.

Other therapies such as intravenous methylprednisolone and immunoglobulin should be
given at the same time to maximize the chances of stopping the haemorrhage and
raising the platelet count.

       10.2.11.2     Neonatal alloimmune thrombocytopenia (NAIT)
Where NAIT is suspected on clinical grounds, transfuse compatible platelets as soon as
possible. Delay may result in an increased risk of severe haemorrhage.

Do not wait for laboratory confirmation of the diagnosis. Transfuse HPA-1a negative, HPA-
5b-negative platelet concentrates as this will be effective in around 95% of cases of NAIT.



Platelet transfusions are indicated in the presence of major bleeding or as prophylaxis to
maintain the platelet count >50 x 109 /l.

If there is no response to HPA-1a negative, HPA-5b negative platelet concentrates, or if the
HPA incompatibility is known to be for HPAs other than HPA-1a or HPA-5b,
consideration should be given to the use of a platelet concentrate prepared from the mother.
Such concentrates should be gamma irradiated and washed, in order to minimize the
transfusion of maternal platelet alloantibodies that may otherwise
prolong the neonatal thrombocytopenia – This cannot be done on site.

   •   N.B. Transfusion of random platelets is unlikely be effective.
   •   The use of I.V. immunoglobulin may produce a response in some patients.
   •   Seek advice from a foetal medicine unit as soon as possible when treating pregnant
       women known to have platelet antibodies or with a history of NAIT.

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10.2.12 Post-transfusion Purpura
Treatment of choice is high-dose intravenous immunoglobulin (2 g ⁄
kg given over 2 or 5 daily) with responses in about 85% of patients.

Platelet transfusions are usually ineffective in raising the platelet count. However platelets
may be required to control severe bleeding in the acute phase. Seek advise of the
Consultant Haematologist.

There is no evidence that HPA-1a-negative platelets are more effective than those from
random donors in the acute thrombocytopenic phase, and the dose of platelets may be more
important than the type of the donor platelets.

There is no evidence to suggest that transfusions in the acute phase prolong the duration or
severity of thrombocytopenia.

11.0 Contraindications To Platelet Transfusions

11.1 Thrombotic thrombocytopenic purpura (TTP) – (unless there is life-threatening
haemorrhage)

11.2 Heparin-induced thrombocytopenia (HIT) - as acute arterial thrombosis can result.

12.0 Minimizing the Use Of Platelet Transfusions

12.1 Use of tranexamic acid:
    • To reduce the requirement for platelet transfusion during consolidation treatment for
        acute leukaemia:
    • For troublesome local bleeding, e.g. oral haemorrhage:
N.B. - contraindicated in the presence of haematuria because of the possibility of ureteric
clot formation.

12.2 Cytokine growth factors:
       A possibility for thrombocytopenia after chemotherapy or stem cell transplant

12.3 Reduction of donor exposure in children:
       By the use of split packs of platelets from the same apheresis donation.

12.4 Correction of concurrent coagulopathy in bleeding thrombocytopenic patients:
        Be sure that platelets and not cryoprecipitate or FFP are required.
12.5 In surgery:
   • Pre-operative cessation of aspirin or other antiplatelet therapy.
   • Intra-operative monitoring of platelet count.
   • Intra-operative use of aprotinin and tranexamic acid.
   • Early return to theatre for surgical bleeding.

13.0 Requesting and Ordering Platelets
Contact the blood bank on ext 8502. A sample will be required for a group unless the patient
has been tested on two previous occasions. The reason for request, including any special
requirements will be indicated on the request form and written in the patient’s notes.

If the request does not fall within the local agreed guidelines the Consultant Haematologist
will be notified before the platelet order is accepted.




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14.0 Selection & Provision of Platelet Products

14.1 ABO compatibility
Platelets of the same ABO group as the patient are the components of choice.

Administration of ABO non-identical platelets is acceptable if platelet concentrates are in
short supply, or when HLA-matched platelets are required and the best match is not ABO
compatible.

Group O platelets for group A, B and AB patients must be negative for high-titre anti-A and
anti-B.

Be aware of possible haemolysis when transfusing of group O platelets to patients of other
ABO groups.
Be aware of possible unexplained platelet refractoriness when transfusing ABO non-identical
platelets.

14.2 Rh D incompatibility
There are no Rh antigens on platelets; however there is a small amount of red cell
contamination in platelet products. Therefore some precautionary measures are required.

RhD-negative patients, particularly women of child bearing age, should be given RhD-
negative platelet concentrates.

If RhD-positive platelets are transfused to a RhD-negative woman of childbearing age, they
should be given 250 i.u. anti-D immunoglobulin. This is sufficient to cover three adult
therapeutic doses of RhD-positive platelets within a 6-week period. It should be given
subcutaneously in thrombocytopenic patients.

14.3 Gamma irradiation
Patients at risk of TA-GVHD should be given gamma-irradiated platelets.

Difficulties are experienced with patients being treated on a shared-care basis, or for later
clinical events, in patients requiring gamma-irradiated blood indefinitely. A patient
information leaflet and card for this purpose are available.

14.4 CMV-seronegative platelets
CMV-seronegative products are indicated for:
   • CMVseronegative pregnant women
   • CMV-seronegative allogeneic haemopoietic stem cell transplant recipients;
   • CMV-seronegative patients undergoing solid organ transplants.
   • CMV-seronegative patients with conditions likely to require allogeneic haemopoietic
      stem cell transplantation.
   • CMV-seronegative patients with HIV infection.
   • Neonatal transfusions.
   • Interuterine transfusions.
   • Other patients at risk of CMV infection / reactivation at the discretion of the clinician.

14.5 Management of red cell T-antigen activation
In this condition, (most common in neonates with necrotizing enterocolitis and in children
with other bacterial infections) exposed T sites on patient red cells may react with anti T in
plasma rich blood products.

Some reports suggest an association between T activation and haemolysis, but a definite
causal relationship has not been established. There is debate whether to use washed blood
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components and low anti-T fresh-frozen plasma. Any perceived benefit of washing platelets
to remove anti-T in plasma must be balanced against the delay in transfusion due to the time
needed for the procedure, the loss of platelets during the process and the effect of washing
on the haemostatic effect of platelets.

15.0 Management Of Adverse Effects
See Policy Management of adverse reactions

Report all incidences.

16.0 Response to Platelet Transfusions
Monitoring of the response to platelet transfusions may serve as a guide to further platelet
supportive care.

Where platelet transfusion was given because of bleeding, the clinical response is the most
important indication of the effectiveness of the transfusion.

Responses to a prophylactic platelet transfusion should be assessed by measuring the
increase in the platelet count following the transfusion.

In practice, a poor response to a prophylactic platelet transfusion can be defined as failure to
raise the platelet count above the ‘trigger’ platelet count for the transfusion.

17.0 Platelet Refractoriness
This is defined as the repeated failure to obtain satisfactory responses to platelet
transfusions. Diagnosis of platelet refractoriness should only be made after a poor response
to two or more platelet transfusions.

17.1 Causes of platelet refractoriness
Causes can be subdivided into immune and non-immune.

       17.1.1 Immune causes of refractoriness

   •   HLA alloimmunization - predominantly in women with a history of pregnancy.
   •   ABO incompatibility.
   •   Platelet autoantibodies.
   •   Drug-related platelet antibodies.
   •   Human platelet antibodies (HPA)

       17.1.2 Non - immune causes of refractoriness

   •   Infection (including its treatment with antibiotics and antifungal drugs).
   •   DIC.
   •   Splenomegaly.
   •   Drugs

17.2 Investigation of refractoriness
Assess clinical factors likely to be associated with non-immune platelet consumption.

If there are no obvious clinical factors present, an immune mechanism should be suspected
and tests for HLA antibodies carried out.

Send the appropriate sample to blood bank for HLA antibodies (lymphocytotoxicity test with
either the lymphocyte or platelet immunofluorescence test or an enzyme-linked
immunosorbent-assay-based method). Tel Blood Bank ext 8501.
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HPA antibodies are rare (0–2%) in the absence of HLA antibodies and do not always cause
platelet refractoriness. It is not necessary to test for HPA antibodies during the initial
serological investigation of platelet refractoriness.

17.3 Management of platelet refractoriness
See Diagram 1 at the end of the document

17.3.1 Patients with alloantibodies
Contact the blood bank laboratory before taking samples for investigation. The tests are
performed by the National Blood Service.

If HLA antibodies are detected on initial serological screening, use HLA-matched platelets.

Give consideration to the presence of non-immune clinical factors, if they appear to be
absent, then test for HPA antibodies.

Monitor post-transfusion platelet counts both 1 h and 20–24 h post transfusion.
If there are improved responses, continue using HLA-matched platelet transfusions. If there
are poor responses to HLA-matched platelet transfusions, the reasons should be sought.

Platelet crossmatching may be helpful in patients with non-specific HPA antibodies.

Managing patients with HLA and ⁄ or HPA alloimmunization without compatible donors may
be very difficult.

There is no evidence that alloimmunized patients benefit from incompatible platelet
transfusions that do not produce an increase in the platelet count, and prophylactic platelet
support should be discontinued.

If bleeding occurs, platelet transfusions from random donors or the best matched donors,
despite being incompatible, may reduce the severity of haemorrhage, although larger doses
of platelets may be required.

Other management approaches for severe alloimmune refractoriness, such as the use of
high-dose intravenous immunoglobulin, splenectomy and plasma exchange, have not been
shown to be effective.

17.3.2 Non immune platelet consumption
This is problematic. The usual practice is to continue with daily platelet transfusions as
prophylactic platelet support, but it is not known whether this approach is effective, or
whether platelet transfusions should be discontinued or the dose of platelets increased.

N.B. See Diagram 1: “Investigation and Management of patient refractoriness to Platelet
Transfusion” at end of this document.




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Diagram 1:

   Investigation and Management of Patient Refractoriness to Platelet Transfusion.




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                   Transfusion Policy
                      Appendix 17
                 Guidelines for the use of
                  Fresh Frozen Plasma,
                   Cryoprecipitate and
                    Cryosupernatant

                     Date: November 2005

                     Ref : PCD 032 – A17

                     Vers : 1

      Policy Profile
      Policy Reference Number     PCD 032-A17
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




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                                Transfusion Policy
                                    Appendix 17
        Guidelines for the Use of Fresh-Frozen Plasma, Cryoprecipitate and
                                  Cryosupernatant



Contents

1.0     Introduction
2.0     Aims and Objectives
3.0     Scope
4.0     Consent
5.0     Risk
6.0     Prescribing / Ordering Red Cell Products
7.0     Administration
8.0     Indications and Recommendations
9.0     Paediatric Use of FFP (See Neonatal Guidelines)
10.0    Patients Who Refuse Transfusion. E.G. ‘Jehovah’s Witnesses’,
11.0    No Justification for the Use of FFFP
12.0    Dosage
13.0    Response to FFP Transfusion
14.0    Risks of Transfusing Plasma Products
15.0    Selecting Suitable Group for Transfusion.
16.0    Reporting Adverse Reactions
17.0    Vaccinating Plasma Recipients
18.0    Product Information


Table I. Principles of selection of FFP according to donor and recipient blood group (ABO)
Table II. Fresh-frozen plasma (FFP) content of electrolytes).
Table III. A comparison of standard FFP with MB FFP and SDFFP.
Table IV. Haemostatic factor content of thawed fresh-frozen plasma (FFP), and after storage at 4°C.




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                               Transfusion Policy
                                   Appendix 17
       Guidelines for the Use of Fresh Frozen Plasma, Cryoprecipitate and
                                 Cryosupernatant

1.0 Introduction
These guidelines are based on British Committee for Standards in Haematology.
BJH 2004; 126, 11-28

2.0 Aims and Objectives
The purpose of this guideline is to assist clinical decisions to transfuse these products so as
to reduce morbidity / mortality associated with major bleeding.
Be aware, these guidelines are important as many of the conventional and widely taught
indications for the transfusion of FFP are not supported by reliable evidence of clinical
benefit.

3.0 Scope
These guidelines are for all clinical staff involved in acute care including clinical
haematologists, paediatricians, surgeons, anaesthetists, blood transfusion practitioners,
biomedical scientists, and nurses, ward and theatre staff.

4.0 Consent
As with all blood products, consider the risks and benefit (see risks below)
Obtain patient consent and recorded this in the notes.
Write clearly, the reason for the transfusion, dose and transfusion rate.

5.0 Risks
 There are additional risks (compared to red blood cells) to consider from plasma products.
See section 14.0 below.

6.0 Prescribing / Ordering Plasma Products.
The blood bank will issue these products without a sample IF the patient has been tested for
blood group on at least two occasions.

If this “historic” group is not available you will need to send a 7ml EDTA sample for group
together with a request form using the same standards as for crossmatch requests.

Before ordering these products.
   • Ensure you have a recent coagulation screen result.
   • Be absolutely certain the product is required and will be transfused.
   • Be specific about the time required.
Once thawed, if not used as requested, these products will be wasted - and
subsequently initiate an incident report.

7.0 Administration of Plasma Products
See Appendix 23 (PCD 032-A23)




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8.0 Clinical Indications for The Use of FFP, Cryoprecipitate & Cryosupernatant

8.1 Indications - In Brief.

              REQUIRED FOR:-
F.F.P.        Immediate reversal of warfarin - ONLY in the presence of bleeding, prior to
15ml/kg       emergency surgery and suspected bleeding to brain or eye.
              Acute DIC
              TTP
              Replace a single coagulation factor where concentrate is not available
              CONDITIONAL USE:-
              Massive transfusion
              Bleeding
              Liver Disease
              Special paediatric indication
              NO JUSTIFICATION:-
              Hypovolaemia
              Plasma exchange procedures
              Nutritional support
              Treatment of Immunodeficiency States

              REQUIRED FOR
Cryoppt       Fibrinogenaemia <1.0g/dl e.g. Acute DIC, Bleeding, Massive Transfusion
10 units

Please note, unless stated otherwise, children born after 1st Jan 1996 will be given virally
inactivated FFP (and cryoprecipitate once it becomes available)

8.2 Indications - In detail

8.2.1 Single factor deficiencies
Only use FFP where no virus-safe fractionated product is available - this only applies to FV
deficiency.

FFP should also be used, rather than FXI concentrate, in patients with congenital FXI
deficiency where there is concern about the potential thrombogenicity of FXI, for example,
during the peripartum period.

8.2.2 Multiple coagulation factor deficiencies
FFP is indicated when there are multi-factor deficiencies associated with severe bleeding
and or DIC.

8.2.3 Hypofibrinogenaemia
Use of cryoprecipitate is to enhance fibrinogen levels. Usually indicated if plasma fibrinogen
level is less than 1 g/l

   •   dysfibrinogenaemia
   •   acquired hypofibrinogenaemia e.g.massive transfusion, DIC.

8.2.4 Disseminated intravascular coagulation (DIC)
       8.2.4.1 Acute DIC
DIC may result in overt microvascular bleeding as well as microangiopathic thrombosis. All
coagulation factors are depleted, but particularly fibrinogen and FV, FVIII and FXIII.

Causes of DIC include:
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   •   Septicaemia
   •   massive blood loss
   •   severe vessel injury
   •   toxins (such as snake venom, amniotic fluid, pancreatic enzymes)

Treat the underlying cause of DIC.

If the patient is bleeding, a combination of FFP, platelets and cryoprecipitate is indicated.
The dose of each is based on pathology results.

        8.2.4.2 Chronic DIC
In chronic DIC or if there is no bleeding, blood products are not indicated, whatever the
results of the laboratory tests.

Usually Transfuse 10 x cryoprecipitate if Fibrinogen is <1.0g/L
Usually Transfuse 15ml/kg FFP if either INR or APP ratio is >1.5

8.2.5 Thrombotic Thrombocytopenia Purpura (TTP)
Single volume daily plasma exchange should ideally begin at presentation, preferably within
24 h. Use virally inactivated FFP or cryosupernatant.

Daily plasma exchange should continue for a minimum of 2 days after remission is obtained.

8.2.6 C1 Esterase inhibitor deficiency
FFP can be used to treat patients who develop severe angio-oedema.

8.2.7 Reversal of warfarin effect
Manage over anticoagulation with warfarin according to BCSH Guidelines (1998).

When there is no evidence of severe bleeding do not use FFP unless patient is, for instance,
are to have urgent surgery.
     • Withdraw warfarin.
     • Give vitamin K orally or parenterally (e.g. 5 mg by slow I.V. injection)

If there is major bleeding in a patient the preferred option is to transfuse Prothrombin
Complex Concentrate - (Beriplex) PCC (50 units/kg). However this is not routinely stocked
by the blood bank. Speak to the Consultant Haematologist.

If there is major bleeding and PCC is unavailable use FFP (12-15 ml/kg)

Simultaneous administration of intravenous vitamin K (5 mg) is also recommended.

8.2.8 Vitamin K policies in ICUs
Do not transfuse FFP to correct the patient’s clotting times. Intensive care unit patients
should routinely receive vitamin K; 10 mg three times a week for adults.

8.2.9 Liver disease
Patients with liver disease and a PT more than 4 seconds longer than control are unlikely to
benefit from FFP.

FFP - 15ml/kg, may be required if the patient is to have surgery, liver biopsy, or has a
variceal rupture.

Avoid giving SDFFP due to depletion of protein S which may cause thrombosis.


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8.2.10 Surgical bleeding / invasive procedures
Whether and how much product should be used depends on blood loss and the platelet and
coagulation results. Be guided by timely tests. Also see massive blood loss below.

Usually Transfuse 15ml/kg FFP if either INR or APP ratio is >1.5
Usually Transfuse 15ml/kg FFP if INR ratio is >1.3 prior to liver biopsy.

8.2.11 Coronary artery bypass graft (CABG) surgery.
Not applicable at DVH
.
8.2.12 Massive transfusion.
Defined as the replacement of a patient’s total blood volume in less than 24 h
OR 50% blood volume loss within 3 h.
OR a loss of 150 ml/min.

Whether and how much FFP should be used for treating a patient with major blood loss
should be guided by timely tests of coagulation.

‘Formulae’ to guide replacement strategies should not be used . There is no evidence that
prophylactic replacement regimes with FFP either prevent the onset of abnormal bleeding or
reduce transfusin requirement.

Usually Transfuse 10 x cryoprecipitate if Fibrinogen is <1.0g/L
Usually Transfuse 15ml/kg FFP if either INR or APP ratio is >1.5

9.0 Paediatric Use of FFP (See Neonatal Guidelines)
Children born after 1 January 1996 should only receive virally inactivated plasma.
MBFFP is available in paediatric volumes.

The most common causes of neonatal bleeding are vitamin K deficiency and
inherited deficiencies of clotting factor activities.

Prematurity may predispose to longer clotting times but on its own is not an indication for
FFP as the clotting times of normal infant blood are longer than those of adults.


As an example, this was taken from a paper, Reference BJH 119; 295-269 2002

APTT secs Day 1 Day 5 Day 30 Day 90 Day 180 Adult
Full term 42.9  42.6  40.4   37.1   35.5    33.5
Premature 53.6  5.05  44.7   39.5   37.5    33.5

9.1 Inherited deficiencies of clotting factors See above
9.2 Haemorrhagic disease of the newborn (HDN)

When haemorrhage due to Haemorrhagic Disease of the Newborn, FFP (10–20 ml/kg) is
indicated, as well as intravenous vitamin K .

Although the coagulation defect in HDN may be reversed by Prothrombin Complex
Concentrate (Beriplex) there are no data to guide dosage in this situation.

9.3 Neonates with coagulopathy and bleeding, or at risk of bleeding from an invasive
procedure.
Neonates with significant coagulopathy, and risk of bleeding or who are about to undergo an
invasive procedure, should receive approximately 15 ml/kg of FFP
as well as a dose of vitamin K.
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Shortening of the prolonged clotting times is unpredictable and should be checked following
administration.

9.4 Prevention of intraventricular haemorrhage in preterm infants
Routine administration of FFP to prevent PVH in preterm infants is not indicated

9.5 Polycythaemia in infancy
There is no indication for the use of FFP in this situation.

9.6 Red cell T antigen activation
Avoiding transfusion of plasma-containing blood components in infants with T-activated red
cells may risk suboptimal treatment for patients requiring haemostasis support.

10.0 Patients Who Refuse Transfusion. e.g. ‘Jehovah’s Witnesses’,
See appendix 5

These patients usually refuse plasma but sometimes accept blood fractions such as clotting
factor concentrates.

11.0 No Justification for The Use Of FFP

11.1 Hypovolaemia
DO NOT USE FFP as a simple volume replacement in adults or in children. Crystalloids are
safer, cheaper and more readily available.

11.2 Plasma exchange (except for TTP or AHUS)
FFP is not required for plasma exchange or adult haemolytic uraemic syndrome.
In the rare event that haemorrhage occurs, a platelet count check before giving FFP is
advisable.

11.3 Reversal of prolonged INR in the absence of bleeding
There is no justification for using FFP to reverse a prolonged INR in the absence of bleeding.

In any patient for whom Pathogen Reduced Plasma (PRP) is being considered, the risks of
HAV and parvovirus B19 transmission and their clinical sequelae should be weighed against
the likely benefits.

12.0 Dosage
The usual dose for FFP is 12-15ml / kg body weight. (Approx 4 packs for adults)
 In massive haemorrhage, the dose depends on the clinical situation and its monitoring.

13.0 Response to FFP Transfusion
Monitor response to transfusion, clinically and with post transfusion clotting screen.

Results serve as a guide to further supportive care.

14.0 Risks of Transfusing Plasma Products
14.1 General risks
The risks of transmitting infection are similar to those of other blood components. E.g.
    • Fluid overload.
    • Immune suppression.
    • Allergic reactions and anaphylaxis.
    • Transfusion-related acute lung injury. (TRALI).
    • Haemolysis due to transfused antibodies to red cell antigens, especially A and B.

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14.2 Particular risk

14.2.1 Risk of Allergy
Allergy resulting in urticaria has been reported in 1–3% of transfusions, whilst anaphylaxis is
rare.

For patients who have proven sensitivity to IgA, IgA deficient plasma is available on request.

14.2.2 Risk of Transfusion Related Acute Lung Injury (TRALI).
 TRALI is significantly but not solely associated with the presence of leucocyte alloantibodies
in donor plasma.

TRALI manifests clinically as severe respiratory distress, with hypoxia, pulmonary
oedema,infiltrates or ‘white-out’ on chest X-ray, and sometimes fever and hypotension,
which usually develops within 4 h of transfusion.

It cannot be distinguished clinically from adult respiratory distress syndrome or
other forms of acute lung injury.


Symptoms usually improve after a few days, although morbid signs can persist for at least 7
days.

14.2.3 Risk of Pathogens
A limited supply of pathogen-reduced plasma (PRP) is available for specific patient groups.

Patients likely to receive multiple units of FFP, such as those with a congenital
coagulopathy, should be vaccinated against hepatitis A and B.

Note, the vaccine for hepatitis A is not licensed for children younger than 2 years old.

         Bacterial Contamination
When frozen, the plastic packs containing these products become relatively brittle and
vulnerable parts of the pack including the stumps of the entry lines can break off if knocked.
Such breakages will allow entry of contaminants. Once thawed, blood bank staff will inspect
units for unexpected appearance such as flocculation or discolouration, or apparent leaks
when the pack is put under pressure. These checks must be repeated at patient bedside
prior to infusion.

        Bacterial growth
To reduce the risk of bacterial growth, thawed plasma and cryosupernatant should be kept at
4oC in an approved blood storage refrigerator before administration. It has a shelf life of 24
hours at this temperature.

Once removed from the blood bank it must be transfused within 4 hours.

        Viral Contamination
Because of the problems of variant Creutzfeldt–Jakob disease (vCJD) UK plasma has been
excluded for fractionation (now sourced from the USA). However, exclusion of UK donors for
all products is neither feasible nor acceptable.

Since 2002, following Departments of Health recommendations, FFP for neonates and
children born after 1 January 1996 is sourced from areas where BSE and vCJD are of low
endemicity and is treated to reduce the risk from transfusion-transmissible diseases (not
prions). In addition, UK NBS can offer a limited supply of treated plasma.

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The various products available are listed below. Also see Table III which compares the 3
FFP products available.

14.2.4 Graft versus host disease (GvHD) and Cytomegalovirus. (CMV)
There are no reported cases associated with these products. They do not need to be
irradiated or CMV tested.

15.0 Selecting Suitable Group For Transfusion.

15.1 ABO compatibility
See Table 1 “ABO blood group compatibility” below.

Generally the blood bank will issue same ABO group plasma products.

If this is not available, FFP of a different ABO group is acceptable so long as it has been
shown not to possess anti-A or anti-B activity above a limit designed to detect ‘high titres’. It
is preferable to use group A FFP for group B patients and vice versa where ABO-identical
FFP is not available.

FFP of group O should only be given to O recipients - This is especially important for infants
or neonates who are not group O because the relatively large volumes required can lead to
passive immune haemolysis

Un-reactive donations are labelled to indicate a relatively low risk of causing ABO related
haemolysis.

Beware: There is no in vitro test to predict in vivo haemolysis.

Group AB FFP can be used in an emergency if the patient’s ABO blood group is unknown,
but is likely to be in short supply.

15.2 RhD blood group compatibility
Although FFP and MBFFP may contain small amounts of red cell stroma, sensitization
following the administration of Rh D-positive FFP to Rh D-negative patients is most unlikely.

FFP, MBFFP and SDFFP of any Rh type may be given regardless of the Rh status of the
recipient. No anti-D prophylaxis is required if Rh D-negative patients receive Rh D-positive
FFP.

16.0 Reporting Adverse Reactions
Adverse reactions to any of these products should be reported to SHOT. In addition, as both
SDFFP and MBFFP are new products to the UK, it is important we report unexpected
problems to the supplier. Contact Blood bank ext 8503.

17.0 Vaccinating Plasma Recipients
Patients with congenital coagulopathy, likely to receive multiple units of FFP should be
considered for vaccination against hepatitis A and B.

18.0 Product Information
See table II Content of electrolytes
See table III A comparison of FFP MBFFP SDFFP
See table IV Haemostatic content of FFP




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18.1 Fresh Frozen Plasma.
UK NBS sourced plasma, either from single whole blood donation or aphereis. Not
processed for pathogen reduction. This is the standard plasma product available.

Volume 300ml +/- 50 ml
Contains all coagulation proteins including the labile FV and FVIII
Usual Dose 12-15ml/kg

18.2 Pathogen Reduced Fresh Frozen Plasma – Methylene Blue Treated (MBFFP).
USA sourced plasma, either from single whole blood donation or aphereis, treated to reduce
pathogens. Usually from male donors only, to reduce risk of HLA and HPA antibodies. Due
to cost and limited supply, this is currently only available for those born on or after 1st
January 1996, patients with TTP or adult haemolytic uraemic syndrome.

Treatment may reduce coagulation factors by 25%.
Paediatric packs available.

18.3 Pathogen Reduced Fresh Frozen Plasma – Solvent Detergent Treated. (SDFFP).
Commercially produced, pooled, USA sourced plasma, manufactured by Octopharma,
treated to reduce pathogens. Not available at DVH at the time of writing this policy.
Prepared from pools of up to 2500 donations.
Has reduced protein S levels

18.4 Cryoprecipitate.
UK NBS sourced plasma from single donations. Not processed for pathogen reduction.

20-40ml
140IU/mL Fibrinogen
Usual dose 10 packs. – (From November 2005 this will be supplied in 5 unit pools).

18.5 Pathogen Reduced Cryoprecipitate.
Methylene Blue treated cryoprecipitate will be available in limited supply from the UK NBS
from the end of 2005 for those born on or after 1st January 1996.

18.6 Cryosupernatant (Cryo Poor Plasma).
UK NBS sourced plasma from single donations. Not processed for pathogen reduction.
Stock not held at DVH, but could be ordered from NBS with prior notification.

300ml +/- 50ml
depleted FVIII and fibrinogen.

Table I. Principles of selection of fresh-frozen plasma according to donor and recipient blood group (ABO).

Recipient group                                       O             A             B            AB
(a) High titre (HT) positive or HT untested units*
 1st choice                                           O             A             B            AB
 2nd choice                                           A             AB            AB           A
 3rd choice                                           B             B             A            B
 4th choice                                           AB

(b) HT negative units
 1st choice                                           O             A             B            AB

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Recipient group                                          O             A              B              AB
 2nd choice                                              A             B              A              A
 3rd choice                                              B             AB             AB             B
 4th choice                                              AB
*Group O must only be given to group O recipients. Group AB plasma is haemolysin free, but often in short
supply.

 Only suitable for emergency use in adults.

 Group O must only be given to group O recipients.




Table II. Fresh-frozen plasma (FFP) content of electrolytes, etc. (mmol/l; an average 'unit' of FFP contains
300 ml).

Na                                         165 (48 mmol/unit)
K                                          3·3 (1·0 mmol/unit)
Glucose                                    20
Calcium                                    1·8 (low)
Citrate                                    20
Lactate                                    3
pH                                         7·2 7·4
Phosphate                                  3·63 (high)
These values were determined in the Pathology Laboratories of Southampton University Hospitals Trust.
The high sodium, glucose, citrate and phosphate levels derive from the anticoagulant preservative mixture,
which also lowers the ionized calcium level.




Table III. A comparison of standard FFP with MB FFP and SDFFP.

                     Standard FFP          Methylene blue FFP*                       Solvent detergent FFP
Source               UK donors, all        USA volunteers donors, all male. Single   Non-UK donors; pools of up
                     previously virus      unit format.                              to 380 l (600 1500 ABO
                     tested. Single unit                                             identical donations)
                     format.
Donation tests
 Serology            HIV, HBV, HCV,        HIV, HBV, HCV, HTLV                       HIV, HBV, HCV, HTLV
                     HTLV
 Genomic             HCV                   HCV, HIV                                  HAV, HCV, B19, HIV, HBV
Virus risk
 HIV 1 + 2           1:10 million          No proven cases reported to date for      NoHIV, HBV, HCV reported
                                           HIV, HBV, HCV (one possible HCV           to date in SDFFP or SD
                                           transmission)                             treated plasma products
 Hepatitis C         1:50 million
 Hepatitis B         1:1·2 million
 Hepatitis A         Rare event                                                      None reported
 Parvovirus B19      Rare event            No greater than for standard FFP. None    Batch withdrawals due to
                                           reported to date.                         possible B19 content.
                                                                                     Seroconversion in patients no
                                                                                     greater than with untreated
                                                                                     FFP.

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                      Standard FFP            Methylene blue FFP*                           Solvent detergent FFP
Volume                180 300 ml              235 305 ml + 50 ml paediatric size.           200 ml; no paediatric size.
                      50 ml paed size.
Coagulation factor    Variable between        Variable between units. 75% units FVIII       Constant within batch. All
content               units. 75% units        >0·5 IU/ml; all other factors >0·5 IU/ml;     factors >0·5 IU/ml.
                      >0·7 IU/ml FVIII        no reduction AT III, protein C, protein S.
                                              No coagulation factor/complement
                                              activation.
Cryoprecipitate/      Available               May become available                          Not available
cryosupernatant
Residual additives    None                    <0·3 mol/l MB. No toxicity seen or            <2 g/ml TNBP**; <5 g/ml
                                              predicted at this level, even in premature    Triton-X 100. Levels not toxic.
                                              neonates.
Allergic reactions    May be reduced by       Reactions attributable to cells would be      Probably less frequent than
                      leucocyte depletion     expected to be reduced.                       FFP.
 Mild                 1%                      No data
 Severe               0·1%                    No data
Adverse reactions                             As for standard FFP                           Pooling reduces all of these
due to antibody                                                                             risks.
Red cell              Tested for high titre   Not tested for high titre anti-A,B            High titre anti-A,B not a
                      anti-A,B                                                              problem since donations
                                                                                            pooled.
 TRALI                >20 cases/year          None reported to date.                        Only one possible TRALI
                      (SHOT)                                                                case reported
 Thrombocytopenia     Very rare
Cellular content      Leucocyte depleted;     Leucocyte depleted; No need to RhD            No intact cells or fragments;
                      No need to RhD          match                                         no need to Rh D match
                      match
Product licence       Not required            Medical device; CE marked                     Licensed, batched product
*See also Garwood et al (2003)                                                     **TNBP, tri-(N-butyl)-phosphate



Table IV. Haemostatic factor content of thawed fresh-frozen plasma (FFP), and after storage at 4°C. A typical
unit of 300 ml includes (IU/ml), except fibrinogen (g/l).

                        Levels when freshly thawed                        Levels at 24 h
Fibrinogen              2·67                                              2·25
FII                     80                                                80
FV                      80                                                75
FVII                    90                                                80
FVIII                   92                                                51
FIX                     100
FX                      85                                                85
FXI                     100
FXII                    83
FXIII                   100
Antithrombin III        100
VWF                     80*
These values were determined in the Pathology Laboratories of Southampton University Hospitals Trust.
Protein C and antithrombin levels are in the 'normal range'
*With some loss of HMW multimers, particularly if SD-treated.



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Hospital Transfusion Committee                             Page 137 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




           Transfusion Policy
              Appendix 18
         Guidelines for the use of
    Prothrombin Complex Concentrate



                     Date: November 2005

                     Ref : PCD 032 – A18

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032-A18
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 138 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational


                               Transfusion Policy
                                  Appendix 18
       Guidelines for the Use of Prothrombin Complex Concentrate (PCC)



Content


1.0    Introduction
2.0    Aims and objectives
3.0    Scope
4.0    Beriflex – the product
5.0    Recommendations for management
6.0    Contraindications
7.0    Using Fresh Frozen Plasma as an alternative.
9.0    Reconstitution of Beriplex
10.0   Adverse events




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Hospital Transfusion Committee                             Page 139 of 225
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                               Transfusion Policy
                                  Appendix 18
       Guidelines for the Use of Prothrombin Complex Concentrate (PCC)

1.0 Introduction
The guidelines described below are written in conjunction with the British Society of
Haematology Guidelines on Oral Anticoagulation (Brit J Haematology, 1998, 101, 374-87)
and recent annotation (Brit J Haematology, 2001, 114, 271-80).

Please note at the time of writing this document Prothrombin Complex Concentrate is not
routinely held in stock by the blood bank at Darent Valley.

2.0 Aims and objectives
To ensure the appropriate management of patients who are bleeding and/or excessive
anticoagulation with warfarin.

3.0 Scope
All involved in the transfusion process, particularly those clinicians working in accident &
emergency and surgery.

4.0 Beriflex – the product
Beriplex is a Prothrombin Complex Concentrate (containing factors II, VII, IX and X) effective
at rapidly reversing warfarin induced anticoagulation.

Rapid anticoagulant reversal is required when there is:
   • life threatening haemorrhage
   • trauma, particularly when associated with head injury
   • prior to emergency surgery.

5.0 Recommendations for management
3.0<INR>6.0 (target INR 2.5)    Reduce warfarin dose or stop for 1-2 days
4.0<INR>6.0 (target INR 3.5)    Restart warfarin when INR<5.0
6.0<INR>8.0                     Stop warfarin
no or minor bleeding            Restart warfarin when INR<5.0
INR>8.0                         Stop warfarin
No or less severe bleeding e.g. Restart warfarin when INR<5.0
haematuria, epistaxis           If risk factors for bleeding give 0.5-1mg IV vitamin
                                K over 2-3 mins or 0.5-5mg oral vitamin K∗.
                                IV effect is quicker (2-6 hrs) than oral (12-24 hrs).
Major bleeding                  Stop warfarin
                                Check APTT, fibrinogen, platelets, U&E, LFTs
                                Give Beriplex 25-50units/kg∗∗ IV as factor IX
                                Give 5mg vitamin K IV
                                Check INR immediately, at 4-6 hrs, then daily.

    ∗ Oral vitamin K – Phytomenadione injection 2mg in 0.2ml (can be given orally)
                              available from Pharmacy.
∗∗Beriplex dosage depending on INR
INR                               Dose (u/kg factor IX)
2.0-3.9                           25
4.0-6.0                           35
>6.0                              50



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6.0 Contraindications
Contraindications:                                           Precautions:
DIC                                                          Sepsis
Uncompensated liver disease                                  Liver disease
Recent documented HIT                                        Pregnancy
Known risks of thrombosis, angina or recent MI

7.0 Using Fresh Frozen Plasma as an alternative.
There is little, if any, place for the use of fresh frozen plasma in the management of oral
anticoagulation overdose but if F.F.P. is used instead of a P.C.C then the recommended
dose is 15ml/kg.

8.0 Obtaining PCC
PCC (Beriplex) is an unlicensed product and will be available on a named patient basis, stored in
Blood Bank and released only if advised by the Consultant Haematologist or SpR

   •   Discuss with the Consultant Haematologist (or SpR).
   •   They will inform the BMS.
   •   The Beriplex is issued by the BMS on the laboratory computer system.

9.0 Reconstitution of Beriplex
    • Warm the diluent supplied to room temperature.
    • Dissolve the dried Beriplex powder with the diluent under aseptic conditions to form a
       colourless solution with no particles.
    • Give the solution as a slow IV bolus over 10-15 minutes.

10.0 Adverse events
It is important you record any adverse events in the patients’ notes and inform the blood
bank.




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Hospital Transfusion Committee                             Page 141 of 225
Transfusion Policy                                         November 2005
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           Transfusion Policy
               Appendix 19
   Guidelines for the use Recombinant
    Factor VIIa in Major Haemorrhage

                     Date: November 2005

                     Ref : PCD 032 – A19

                     Vers : 1

      Policy Profile
      Policy Reference Number     PCD 032-A19
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 142 of 225
Transfusion Policy                                              November 2005
Ref: PCD 032(v1)                                            Status : Operational




                                Transfusion Policy
                                   Appendix 19
       Guidelines for Use of Recombinant Factor VIIa in Major Haemorrhage


Contents

1.0     Introduction
2.0          Aims and Objectives
3.0          Scope
4.0          Rationale
5.0     Essential prerequisite of use
6.0     Patients
7.0     Recommendation
8.0     Indications for treatment
8.1     Trauma – blunt
8.2     Trauma – penetrating
8.3     Surgical
8.4     Coagulopathy
8.5     Obstetric
8.6     General
9.0     Guideline
9.1     Specific contra-indications for the use of rFVIIa
10.0    Authorisation for use
11.0    Dosage of rFVIIa
11.0         Product
12.0         Issue
13.0         Administration
14.0         Efficacy
15.0    Laboratory Investigations
16.0    Audit of rFVIIa use
17.0    Risk
18.0    References
19.0    Table – dose calculator
20.0    Audit Form




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Hospital Transfusion Committee                             Page 143 of 225
Transfusion Policy                                                       November 2005
Ref: PCD 032(v1)                                                     Status : Operational



                               Transfusion Policy
                                  Appendix 19
      Guidelines for Use of Recombinant Factor VIIa in Major Haemorrhage

1.0 Introduction
Recombinant factor VIIa (rFVIIa) is licensed for the treatment of bleeding in patients with
inhibitors in congenital and acquired Haemophilia.
However a growing number of case reports suggest that used “off licence” in a single dose may
rapidly control intractable bleeding in cases without coagulopathies that have not responded to
standard management of haemorrhage, including repeated blood transfusion.

Please note, at the time of writing this document rFIIa is not routinely held in stock by the blood bank
at Darent Valley Hospital.

2.0 Aims and Objectives
The effective use of an expensive alternative to blood transfusion.

3.0 Scope
Those staff managing patients who have major haemorrhage.

4.0 Rationale
Factor VIIa is an initiator of thrombin generation. It works directly with tissue factor at the site of a
haemorrhage to accomplish haemostasis (clotting). It has been shown that it may be more effective
if used earlier in the course of bleeding. For maximum benefit this should be given prior to the onset
of the complications associated with massive blood transfusion

5.0 Essential prerequisite of use
This is a very expensive product. A single adult dose will cost approximately £3500. It
should therefore be administered at a time when it will be most effective.

It will only be effective if the patient has sufficient platelets (above 40 x 109/l ) and fibrinogen
for it to act with. Therefore it is imperative that every effort is made to correct deficiencies in
platelets and coagulation factors by administering appropriate platelet, plasma and
cryoprecipitate or fibrinogen concentrate transfusions prior to considering treatment with
rFVIIa.

The product will be ineffective if the patient is acidotic.

It is important the patient is not hypothermic – Use a blood warmer for transfusions and
minimise exposed wound area etc.

6.0 Patients
It may not be suitable for all patients, especially those with risk factors for thrombo-embolic
disease or disseminated intra vascular coagulation.

It is acceptable for use in Jehovah’s Witness patients.

7.0 Recommendation
At this point there can be no firm recommendations for the use of Factor VIIa in severe
traumatic haemorrhage. Factor VIIa is not yet licensed in any country for this condition, and
its use proceeds on a 'compassionate' basis. Given the high cost associated with using
Factor VIIa, its use should be restricted to those situations where it is likely to be of

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Hospital Transfusion Committee                             Page 144 of 225
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maximum benefit. Additionally, evidence is emerging that the coagulant and metabolic milieu
must be favourable, or made favourable, for the drug to work.

8.0 Indications for treatment
8.1 Trauma – blunt          rFVIIa can be effective in treating non-penetrating impacts
                            such a vehicle accidents and falls.
8.2 Trauma – penetrating rFVIIa will not be effective. See surgical below.

8.3 Surgical                  rFVIIa will not stop surgical bleeding. Consider its use for
                              severe peri- or post-operative haemorrhage refractory to
                              conventional management that persists despite optimal blood
                              product replacement and surgical haemostasis
                              Continued brisk blood loss (>200mls per hour) despite
                              correction of coagulopathy and optimal surgical management.
8.4 Coagulopathy              Non-surgical haemorrhage associated with coagulopathy
                              refractory to conventional management
8.5 Obstetric                 Severe obstetric haemorrhage where surgical intervention has
                              failed to control the bleeding.
                              Severe obstetric haemorrhage in women refusing blood
                              products, when exsanguination appears possible.
8.6 General                   Non-surgical haemorrhage not responsive to treatment;

9.0 Guideline
Consider the use of rFVIIa if a patient has
    • has received more than 10 units of red cells in under 24 hours and is still bleeding
       significantly.
    • and has received at least 2 doses of platelets for treatment of thrombocytopenia
       with no demonstrable benefit.
    • and has received at least 1 litre of FFP and/or 10 units of cryoprecipitate for
       treatment of coagulopathy with no demonstrable benefit.
    • and surgical measures to achieve haemostasis have been unsuccessful.
    • is a Jehovah’s Witness with life-threatening haemorrhage.

9.1 Specific contra-indications for the use of rFVIIa
rFVIIa may occasionally be associated with thrombosis – avoid in micro-vascular surgery
and in patients with severe vascular disease. Use with caution if evidence of established
disseminated intravascular coagulation.

Do not use rFVIIa if the overall outlook is so poor that arresting haemorrhage is unlikely to
improve the outcome.

Carefully monitor patients with history of allergic reactions as it contains trace amounts of
mouse, bovine or hamster proteins.

10.0 Authorisation for use
The use of rFVIIa must be approved by the Consultant Haematologist, after discussion with
the Consultant in charge of the case.

11.0 Dosage of rFVIIa
Licensed dose: For use in haemophiliac’s refractory to FVIII.

The licensed dose, for use in haemophiliacs, is 90 µg/kg (4.5 Kiu / kg) by slow IV bolus.
This can be repeated after 2 hours if there is still significant blood loss.



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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 145 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
11.0 Product
Available as 1.2 mg, 2.4 mg and 4.8 mg vials.

Avoid wastage of rFVIIa by selecting appropriate vial sizes to achieve desired dosage. (See
appendix for dosage table)

The product has a half life of 2 hours.

If there is no response, a second dose may be considered one to three hours after the first
dose.
There is no known benefit from subsequent doses if two doses have failed to produce a
response.

12.0 Issue
rFVIIa will be issued via the Blood Bank. It is a powder for injection with accompanying solvent for
reconstitution (water for injections)

Please mix gently to avoid frothing

13.0 Administration
The rFVIIa is dissolved in the accompanying solvent before use. After reconstitution, the solution
contains 0.6 mg rFVIIa/ml.

Administer by intravenous bolus injection over 2-5 minutes.
DO NOT mix with infusion solutions or given in a drip.

14.0 Efficacy
Effective resolution of bleeding has been reported within minutes of administration.
The primary measure of haemostatic efficacy is the clinical assessment of bleeding has stopped,
decreased or unchanged.
A reduction in blood product usage is a secondary measure of haemostatic efficacy.

15.0 Laboratory Investigations

       •    Pre-Treatment                 FBC, PT, APTT, Fibrinogen and d-dimer

       •    20 minutes post -infusion     FBC, PT, APTT, Fibrinogen and d-dimer

The PT will shorten dramatically and the APTT may shorten also. However, these effects
may not be long lasting and further monitoring will be required according to the clinical
situation

16.0 Audit of rFVIIa use
The batch number, vial size and number of vials used along with the patient’s name and
hospital number will be logged on Telepath by the Blood Bank. The issue slip should be
placed in the patient’s notes.

Prospective audit of the protocol will be undertaken to assess the appropriateness and
safety of rFVIIa use. All users must fully complete an audit form following use of the product
(see Appendix *****) below.

The details of all patients who receive rFVIIa as well as comments about this protocol should
be sent to Dr Ezekwesili Consultant Haematologist.



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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 146 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational
17.0 Risk
There is no risk of transmission of human viruses.
Serious adverse reactions are rare but include arterial / venous thrombotic events.
It may be appropriate to consider bilateral lower limb ultrasound to check for DVT 3-5 days
following rFVIIa administration.

18.0 References
   • Hedner U. (2000) NovoSeven as a universal Haemostatic agent.
       Coagul Fibrinolysis: 11 Suppl 1: S107-11
   • Williams D. McCarthy R. (2003) Recombinant activated Factor VII and perioperative
       blood loss.
       Lancet; 361: 1745-6
   • Tanaka KA, Waly AA, Cooper WA, Levy JH (2003) Treatment of excessive bleeding
       in Jehovah’s Witness patients after cardiac surgery with recombinant factor VIIa
       (NovoSeven)
       Anaesthesiology; 98 : 1513-5
   • O’Connell NM, Perry DJ, Hodgson AJ, O’Shaughnessy DF, Laffan MA, Smith OP.
       (2003)
       Recombinant Factor VIIa in the management of uncontrolled haemorrhage.
       Transfusion; 43: 1711-6
   • Eikelboom J, Bird R, Blythe D et al. (2002) Recombinant activated factor VII for
       massive haemorrhage in non-haemophilia patients: The Australian experience.
       Blood; 100 : 711
   • Hedner U, Erhardtsen E. (2002)         Potential role for rFVIIa in Transfusion medicine.
       Transfusion ;42 : 114-24
   • Moscardo F, et al. (2001)       Successful treatment of severe intra-abdominal
       bleeding associated with disseminated intravascular coagulation using recombinant
       activated factor VII.
       Br J Haematol 113: 174-176




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Hospital Transfusion Committee                             Page 147 of 225
Transfusion Policy                                          November 2005
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19.0 Table – dose calculator


Body weight (kg)     Each dose   Each dose    Vials required (mg)
                     (KIU)       (mg)         for ONE dose


10                   45          0.9          1 x 1.2

15                   67.5        1.35         1 x 2.4

20                   90          1.8          1 x 2.4

25                   112.5       2.25         1 x 2.4

30                   135         2.7          1 x 2.4 + 1 x 1.2

40                   180         3.6          1 x 2.4 + 1 x 1.2

50                   225         4.5          1 x 4.8

60                   270         5.4          1 x 4.8 + 1 x 1.2

70                   315         6.3          1 x 4.8 + 1 x 2.4

80                   360         7.2          1 x 4.8 + 1 x 2.4

90                   405         8.1          1 x (4.8+2.4+1.2)

100                  450         9            2 x 4.8




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 148 of 225
Transfusion Policy                                                     November 2005
Ref: PCD 032(v1)                                                   Status : Operational

20.0 Audit Form


             AUDIT DATA FOR EXTENDED USE OF RECOMBINANT FVIIa

      Patient Name …………………                   Date of First Dose ……………………..
      Date of Birth ………………….
      Hospital Number……………..                 Body weight (Kg) ……………………….
      Sex ……………………………

      Primary Diagnosis




      Clinical Scenario – requiring rFVIIa




     Pre treatment coagulation results.                     Time of
     sample………………….

     Plts………………..             PT…………….              APTT……………

     D dimmer………….            Fib g/l………….



              Dosage of r FVIIa (mg)          Number of doses




     Clinical efficacy:
     Bleeding:- prevented /stopped / greatly reduced / possible reduced / /unchanged


     Immediate Outcome (24hr):




      Number of blood products used PRIOR to FIRST DOSE (24hr):

      RBC………. …. FFP…………….... PLTS …..………..…CRYO………………

      Number of blood products used AFTER FIRST DOSE (24hr):

      RBC……….….. FFP………………. PLTS …..……….... CRYO………………


      Form Completed by:




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 149 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




              Transfusion Policy
                 Appendix 20
        Guidelines for the use of Anti D
                Immunoglobulin
                     Date: November 2005

                     Ref : PCD 032 – A20

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032-20
      Version                     1
      Status                      Operational
      Trust Lead                  LDelieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 150 of 225
Transfusion Policy                                              November 2005
Ref: PCD 032(v1)                                            Status : Operational


                                Transfusion Policy
                                   Appendix 20
                             Guidelines for the Use of
                        Prophylactic Anti-D Immunoglobulin

Contents

1.0      Introduction
2.0     Aims and Objectives
3.0     Scope
4.0     Consent
4.1     Consent For Routine Antenatal Anti D Prophylaxis (RAADP)
4.2     Information Leaflet
5.0     Risk
6.0     Prescribing / Ordering Anti D Immunoglobulin
7.0     Administration
8.0     Risk of large Feto/maternal Haemorrhage
9.0     Prophylaxis Following Abortion
9.1     Therapeutic Termination Of Pregnancy:
9.2     Ectopic Pregnancy:
9.3     Spontaneous Miscarriage:
9.4     Threatened Miscarriage:
10.0    Prophylaxis Following Sensitising Events Before Delivery
11.0.   Postnatal Prophylaxis
12.0    Routine Antenatal Prophylaxis
13.0    Transfusion Of Rhd Positive Blood Components
13.1    RhD Positive Platelet Transfusions:
13.2    RhD Positive F.F.P. And Cryoprecipitate Transfusions:
13.3    Inadvertent Transfusion Of RhD Positive Blood:
14.0    Conclusion And Summary Of Recommendation




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 151 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational

                                 Transfusion Policy
                                    Appendix 20
                              Guidelines for the Use of
                         Prophylactic Anti-D Immunoglobulin

1.0 Introduction
This is based on guidelines published by National Institute for Clinical Excellence’s
Technology Appraisal Guidance No 41 Guidance on the use of routine antenatal anti-D
prophylaxis for RhD-negative women, May 2002. and the Royal College of Obstetricians and
Gynaecologists' 'Green Top' 199guideline:
 Use of Anti-D Immunoglobulin for Rh Prophylaxis (AADP). (22) – Revised May 2002

2.0 Aims and Objectives
To ensure anti D prophylaxis is offered to all non-sensitised pregnant women who are Rh D
negative when they are exposed to Rh D positive red cells whether this be foetal maternal
haemorrhage or exposure to blood products.

The treatment is required to prevent women producing anti D antibodies, which might cause
Haemolytic Disease of the Newborn in future pregnancies. H.D.N. in its worse form may
result in stillbirth or infants with severe disabilities.

3.0 Scope
This document will cover recommendations of routine antenatal anti-D prophylaxis (RAADP)
(i.e. routine prophylaxis at 28 and 34 weeks) and prophylactic anti-D given because of likely
sensitisation. It is aimed at all staff responsible for the management of Rh D negative
women of child bearing age including obstetricians, midwifes, general practitioner, staff
working in A&E and laboratory staff.

4.0 Consent
Anti D immunoglobulin is a blood product, and although risks associated with administration
are very low, the clinician must explain the risks and benefits, obtain consent and record this
in the patients notes.

4.1 Consent for RAADP
RAADP will be administered at 28 and 34 weeks of pregnancy.

The clinician (obstetrician, midwife or general practitioner) responsible for the prenatal care
of a non-sensitised RhD-negative woman should discuss with her RAADP and the options
available so that the woman can make an informed choice about treatment. This discussion
should include the circumstances where RAADP would not be necessary. which include:
       • Patient to be sterilised after the birth of the baby.
       • Patient in a stable relationship with the father of the child, and the father is known
            or found to be RhD-negative.
       • Patient Is certain that she will not have another child after her current pregnancy.


The difference between RAADP (at 28 and 34 weeks) and prophylactic anti-D given because
of likely sensitisation should be clearly explained to the woman.

A woman's use of RAADP at 28 and 34 weeks should not be affected by whether she has
already had antenatal anti-D prophylaxis (AADP) for a potentially sensitising event early in
pregnancy.



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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 152 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
A woman's use of postpartum anti-D prophylaxis should similarly not be affected by whether
she has had RAADP or AADP as the result of a sensitising event.

The patient has a right to refuse anti D. Reason for refusal must be recorded.

4.2 Information Leaflet
The Obstetrics department has information leaflets available for patients.

5.0 Risk
In view of the theoretical risk of vCJD posed by UK plasma all anti-D produced by BPL is
now manufactured from plasma sourced from the USA. The production process includes
steps to minimise the risk of viral contamination.
Occasionally anti-D prophylaxis causes allergic responses in the mother, but these are rare.

6.0 Prescribing / Ordering Anti D Immunoglobulin
Write clearly the reason for administration and dose in the patient’s notes.
Write the dose and time for administration on the patient’s prescription chart.
Contact the blood bank on ext 8502, they are likely to require a pre-administration EDTA
sample for group and save, with an accompanying pink request form. Please ensure these
are labelled according to crossmatch guidelines.

NB There is sometimes confusion with regard to patients whose Rh D status is not clearly
Postive or Negative, that is those patients who have a weak expression of the antigen (Du)
or those with a partial deletion ( e.g. Category VI) . In brief, those who have a weak
expression of the RhD blood group (Du) do not form anti-D and do not require prophylaxis.
Those who are Category VI will be routinely grouped as D Negative and will therefore be
given anti G Ig. It should be noted that anti-D Ig does not protect against the development of
other antibodies which can cause haemolytic disease of the newborn (e.g. Anti K). If you
have any queries contact the blood bank laboratory.

7.0 Administration
Intramuscular anti-D Ig should be given into the deltoid muscle. Injections into the gluteal
region often only reach the subcutaneous tissues and absorption may be delayed. NB If
patient is known to be thrombocytopenic DO NOT administer anti D. Contact the
Consultant Haematologist for advise.

Anti-D Ig should be given as soon as possible after the sensitising event but always within
72 hours. If it is not given before 72 hours, every effort should still be made to administer the
anti-D Ig, as a dose given within 9-10 days may provide some protection. Women who are
already sensitised should not be given anti-D Ig.

8.0 Risk of Large Feto/maternal Haemorrhage (FMH)
The following clinical circumstances are more likely to be associated with large FMH:
        • traumatic deliveries including:-
               o caesarean section.
               o manual removal of the placenta.
               o stillbirths and intrauterine deaths.
               o abdominal trauma during the third trimester.
               o twin pregnancies (at delivery).
               o unexplained hydrops fetalis.

9.0 Prophylaxis Following Abortion
Some RhD negative women require anti-D Ig following abortion; (see below)
250iu before 20 weeks gestation.
500iu after 20 weeks gestation. A test for the size of FMH should be performed when anti-D
Ig is given after 20 weeks.
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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 153 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational

9.1 Therapeutic termination of pregnancy:
Anti-D Ig should be given to all non-sensitised RhD negative women having a therapeutic
termination of pregnancy, whether by surgical or medical methods, regardless of gestational
age.

9.2 Ectopic pregnancy:
Anti-D Ig should be given to all non-sensitised RhD negative women who have an ectopic
pregnancy..

9.3 Spontaneous miscarriage:
Anti-D Ig should be given to all non-sensitised RhD negative women who have a
spontaneous complete or incomplete abortion after 12 weeks of pregnancy.

9.4 Threatened miscarriage:
Anti-D Ig should be given to all non-sensitised RhD negative women with a threatened
miscarriage after 12 weeks of pregnancy.
Where bleeding continues intermittently after 12 weeks' gestation, anti-D Ig should be given
at 6-weekly intervals.

It may be prudent to administer anti-D Ig where bleeding is heavy or repeated or where there
is associated abdominal pain particularly if these events occur as gestation approaches 12
weeks. The period of gestation should be confirmed by ultrasound.

10.0 PROPHYLAXIS FOLLOWING SENSITISING EVENTS BEFORE DELIVERY
Anti-D Ig should be given to all non-sensitised RhD negative women after the following
potentially sensitising events during pregnancy:
               • Invasive prenatal diagnosis (amniocentesis, chorionic villus sampling,
                    foetal blood sampling).
               • Other intrauterine procedures (e.g. insertion of shunts, embryo reduction).
               • Ante partum haemorrhage.
               • External cephalic version of the foetus.
               • Closed abdominal injury.
               • Seat belt injury
               • Intrauterine death

A dose of 250iu is recommended for prophylaxis following sensitising events up to 20 weeks
of pregnancy.

For all events after 20 weeks, at least 500iu anti-D Ig should be given followed by a test to
identify FMH greater than 4ml red cells; additional anti-D Ig should be given as required.

11.0. Postnatal Prophylaxis
At least 500iu of anti-D Ig must be given to every non-sensitised RhD negative woman within
72 hours following the delivery of a RhD positive infant. This includes women with
alloantibodies other than anti-D.

A test to detect FMH greater than 4ml must also be undertaken, so that if the FMH is greater
than 4ml additional anti-D Ig can be given. (FMH determined by the Kleihaurer test). NB on
the rare occasion a large FMH is found, the blood bank laboratory may advise further tests
and further samples to be taken.

Some women who have received anti-D Ig during pregnancy may have detectable anti-D in
their blood at delivery. Because it may be difficult or impossible to distinguish between such
passive anti-D Ig and weak anti-D resulting from early immunisation, anti-D Ig should be
__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 154 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
given to any eligible woman with weak anti-D antibody at delivery unless it has been clearly
confirmed that she is already sensitised.

12.0 Routine Antenatal Prophylaxis
A patient information leaflet is available from Obstetric Department.

Patients will be offered RAADP even if they have already had AADP for a potentially
sensitising event earlier in your pregnancy.

At least 500iu of anti-D Ig should be given to non-sensitised RhD negative women at 28
weeks and 34 weeks of pregnancy according to NICE guidance.
For NICE’s guidance on the use of routine antenatal prophylaxis. (www.nice.org.uk)

Postnatal anti-D prophylaxis will be offered to relevant patients, whether or not they have
had AADP or RAADP.

13.0 Transfusion of RhD Positive Blood Components
13.1 RhD positive platelet transfusions:
Usually RhD negative platelets are provided for RhD negative women of childbearing age. If
an appropriate product is not available and it is necessary to use RhD positive platelets,
prophylaxis against possible Rh alloimmunisation by red cells contaminating the platelet
product should be given.
250iu anti-D Ig should be given following every three adult doses of platelets. Patients who
have marked thrombocytopenia should be given the anti-D Ig subcutaneously to avoid the
possibility of a haematoma following intramuscular injection.

13.2 RhD positive F.F.P. and cryoprecipitate transfusions:
Improved manufacturing techniques for these blood product means the risk of red cell
contamination is low and antiD is therefore not required.

13.3 Inadvertent transfusion of RhD positive blood:
<15ml of RhD positive blood transfused. Give appropriate dose of anti-D Ig .

>5ml have been transfused. Use the larger anti-D Ig IM preparation (2500iu or 5000iu),
calculated on the basis of 500iu of anti-D Ig for every 4ml of RhD positive red blood cells
transfused
.
When more than 2 units of RhD positive blood have been transfused, consideration should
be given to undertaking an exchange transfusion. The patient should be counselled
regarding the implications of both non-intervention (for future pregnancies) and of treatment,
including any hazards from receiving donated blood, the exchange procedure itself and of
larger doses of anti-D Ig including IV anti-D
In this situation contact the Consultant Haematologist for specialist advice.

14.0 Conclusion and Summary of Recommendation
Following delivery, irrespective of the dose of anti-D Ig routinely administered, postnatal
prophylaxis must include a screening test to identify women with a large FMH who need
additional immunoglobulin.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 155 of 225
Transfusion Policy                                                November 2005
Ref: PCD 032(v1)                                              Status : Operational
Anti-D Ig should be given after sensitising events before delivery and after abortion.
Anti-D Ig is no longer necessary in women with threatened miscarriage with a viable foetus
and cessation of bleeding before 12 weeks' gestation
At least 500iu of anti-D Ig should be given to non-sensitised RhD negative women at 28
weeks and 34 weeks of pregnancy according to NICE guidance.
It is important that women have all the necessary information to enable them to make an
informed choice about Rh prophylaxis. Information sources must indicate that anti-D Ig is a
blood product. There is now an urgent need to address the implementation and monitoring of
the new guidelines.




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 156 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




                       Transfusion Policy

               Appendix 21
    Collection and Delivery of Blood for
                Transfusion

                     Date: November 2005

                     Ref : PCD 032 - A21

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032-A21
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 157 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational


                                    Transfusion Policy
                                       Appendix 21
                     Collection and Delivery of Blood for Transfusion


Contents


1.0    Introduction
2.0    Aim and Objectives
3.0    Scope
4.0    Trained Personnel
5.0    Location of Blood Bank at Darent Valley Hospital.
6.0    Prior to collection
7.0    Procedure for collection
8.0    Collecting Blood for Theatre
9.0    Delivery to Clinical Area
10.0   Blood delivered which cannot be transfused
11.0   Emergency O Negative Blood
12.0   Other blood products.
13.0   Receiving Blood Transferred to D.V.H. from another Hospital.
14.0   Guidelines for Transferring blood with a patient to another Hospital.
14.1   Decision to send blood with a patient.
14.2   Patient departure
14.3   Blood in transit to another hospital.

Form 1 Transferring blood to another hospital A&E checklist.
Form 2 Blood/Blood Products Transfer Form (for laboratory use only)




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 158 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
                                    Transfusion Policy
                                       Appendix 21
                     Collection and Delivery of Blood for Transfusion

1.0 Introduction
Collection of the wrong unit of blood if often identified as the first error implicated when a
patient is transfused an incorrect unit of blood (S.H.O.T. Report). As with all transfusion
associated processes, blood collection must be done correctly.

2.0 Aim and Objectives
Ensure correct collection procedures are followed to reduce the burden of risk on those
performing the pre transfusion bedside check.

3.0 Scope
All involved in the transfusion process, particularly those responsible for collecting blood and
their line managers.

4.0 Trained Personnel
Blood must only be removed from the blood bank by trained personnel. All porters are
trained in collection procedures and should be used for this purpose.

Other personnel will be trained by Blood Bank staff. Please contact the BMS3* on ext 8501
to arrange this.

Carillion train the porters using an approved training package. All training is documented.

5.0 Location of Blood Bank at Darent Valley Hospital.
From 9.00 hr to 17.00 hr blood products will be located in the laboratory Blood Bank
within Pathology.

From 17.00hr to 09.00 hr blood products will be in the Pathology Blood Bank, located in a
small room next to Pathology, accessed from the corridor main street. This requires ID
badge entry.

There is a satellite blood bank on Haem-Oncology Suite for day patients only. It is the
responsibility of the senior staff within that area to ensure the security of the
products and see that staff adhere to collection procedures. Blood must not be stored
overnight or weekends in this blood bank. Any unused units must be returned to the
main blood bank by 17.00 hr Mon - Fri.

Blood must only be stored in a refrigerator which is designated for the purpose and
compliant with standards required by Clinical Pathology Accreditation (UK) Ltd. It must never
be stored in any other refrigerator e.g. drug or food refrigerator.

6.0 Prior to collection
Do not send for blood until all pre administration checks have been done (see ICP) to ensure
patient and staff are ready for the transfusion to proceed.

The collector will bring the patients IV prescription chart or case notes and a blood transport
box (available on each ward) to the blood bank, i.e. porters will only come to the blood bank
after collecting these from the clinical area.

Collect blood for one patient at a time.
(Exceptions include H.O.C. taking daily requirement to their blood bank and theatre).


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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 159 of 225
Transfusion Policy                                                        November 2005
Ref: PCD 032(v1)                                                      Status : Operational
7.0 Procedure for collection
Before opening the blood bank, go to the blood issue register (a red ring binder). This
register lists the units of blood available in the blood bank.

Locate the patient’s compatibility (pink) form in the register. If it is not there contact a
member of blood bank staff (or on call Haematology BMS out of hours).

Having located the form, check the patients full name, gender, date of birth and hospital
number against the information on the I.V. prescription chart (or case notes). Any
discrepancy must be brought to the attention of blood bank staff.
DO NOT PROCEED UNLESS ALL THE INFORMATION IS CORRECT.

The compatibility form (pink form) will list the blood products available for the patient.

Open the blood bank and find the patient’s blood. The first unit will have documentation with
it (an I.C.P.) which must remain with the unit.

Remove one unit only. (Exception may be for theatre patients or an extreme emergency
when a rapid transfusion is needed).

Take the blood to the register. Crosscheck the patient information on the Blood bag label
against the i.v. prescription chart. Any discrepancy must be brought to the attention of blood
bank staff.
DO NOT PROCEED UNLESS THE INFORMATION IS CORRECT.

Check that the compatibility label is attached to the correct unit of blood. Check donation
number, blood group, product type and expiry date. Any discrepancy must be brought to the
attention of blood bank staff.
DO NOT PROCEED UNLESS THE INFORMATION IS CORRECT.

Finally, check the integrity of the pack e.g. that it is not leaking, discoloured, already spiked
etc. Any faults must be brought to the attention of blood bank staff

When you are sure all the patient and product information is crosschecked and correct, the
blood MUST be logged out legibly on the compatibility sheet.

On the pink compatibility sheet, write the date and time (24hr clock) and your name legibly
against the unit being removed.

Place the blood in the designated insulated transport box. Take the blood immediately to the
clinical area. Do not detour.

8.0 Collecting Blood for Theatre
It is strongly suggested that theatre check TPath to ensure availability of blood before the
patient is taken to the operating room.

It is suggested blood is not collected from the blood bank until it is required for transfusion.

Unless the patient is bleeding heavily, collect one unit at a time.

Where more than one unit is collected, ensure it is kept in the transport box until needed.
Blood in this box will be subject to the same rules as above in that:-
   • If returned to the blood bank after 30 minutes it will be discarded.
   • Any blood in the transport box must be used within 4 hours of collection.


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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 160 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
9.0 Delivery to Clinical Area

Porters who deliver a blood product to a clinical area must report product arrival to a
member of the nursing staff who will check it. If they find any problems the blood must be
returned to the blood bank immediately.

10.0 Blood delivered which cannot be transfused
Blood that is delivered but cannot be transfused within 30 minutes must be returned to the
Blood Bank as soon as possible.

The returnee may place the blood back into the blood bank providing this is done within 30
minutes of removal. Document legibly the time returned to refrigerator on the pink form in the
blood bank register.

If concerned / unsure of what to do or if the blood has been out of the blood bank for more
than 30 minutes, seek advice from a member of the Blood Bank staff.

Blood which has been out of the refrigerator longer than 30 minutes and will not be
transfused within 4 hours must be returned to the blood bank for disposal. (Because of the
risk of bacterial proliferation)
Do not put it into clinical waste as the laboratory must record the fate of blood and report to
blood stocks management scheme and the MHRA.
Do not put it into the blood bank as it may, inadvertently, be recollected.

11.0 Emergency O Negative Blood
This is only used in life threatening situations and must be collected from Blood Bank staff in
the laboratory.

12.0 Other blood products.
The same “rules” apply as for the collection of blood.

Platelets are stored at room temperature in a temperature controlled platelet agitator;
therefore they are always collected from the laboratory. Administer as soon as possible upon
receipt.

FFP should be administered as soon as possible after thawing. Once thawed, the expiry
time is 24 hours if stored in a blood bank refrigerator. After leaving the blood bank
refrigerator the product must be transfused within four hours. As with red cells, if the product
is removed and not to be used within 30 minutes it must be returned to the blood bank.

Cryoprecipitate must be administered as soon as possible following collection and receipt.

13.0 Receiving Blood Transferred to D.V.H. from another Hospital.
Blood received from another hospital must be taken to the Blood Bank laboratory and given
to a member of staff. He/She will determine the integrity of the units, take ownership and
enter the products onto TPath data base, as required by law.

14.0 Guidelines for Transferring blood with a patient to another Hospital.
Please be aware:-
   • If unused en route, the blood will most probably, be discarded by the receiving
       hospital unless the product is taken directly to the blood bank and the packaging has
       remained sealed. (Cost to DVH £132/unit)
   • Ambulance crew will not transfuse a patient.
   • Most receiving hospitals prefer to use blood grouped & cross-matched by their own
       pathology department.

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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 161 of 225
Transfusion Policy                                                     November 2005
Ref: PCD 032(v1)                                                   Status : Operational
14.1 Decision to send blood with a patient.
This decision will be made by a Registrar or Consultant. See Form 1

It should only be sent in exceptional circumstances e.g. AAA. Uncontrolled bleeding etc.

It is suggested no more than two units accompany a patient.

As soon as a decision to send blood has been made inform the blood bank laboratory/on call
BMS. State:-
   • Patient information.
   • Expected time of transfer
   • Expected destination of patient.

The laboratory staff on duty will pack the blood in a transit box with ice packs, enclose the
relevant paperwork (see form 2) and zip tie it closed.

Do not send for the blood until the patient is ready to depart.

Collect the box from the duty BMS. Bring patient chart with you. The units will be signed out
in the usual way.

14.2 Patient departure
A&E will contact the Blood Bank/BMS on duty to confirm the destination of the patient &
blood and that they have left DVH.

The BMS on duty will telephone the blood bank at the receiving hospital and give patient and
unit details.

14.3 Blood in transit to another hospital.
If the blood is not required in transit do not break the seal on the transport box.

If blood is required, the accompanying doctor must follow the proper blood administration
protocol.

On arrival at the receiving hospital arrangements must be made to transfer the units to the
blood bank as soon as possible.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 162 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
Form 1

          Transferring Blood With a Patient to Another Hospital.

                                      A&E Checklist

                                                                              Tick Box

   1. Decision to transfer blood will be made by a Registrar/Consultant.             □

                                              Name ……………………………..

   2. This will require an exceptional reason e.g. AAA, arterial bleeding.           □

                                              Reason…………………………….

   3. The patient will be accompanied by a doctor/nurse able to
      administer blood en route.                                                     □

   4. No more than two units to accompany a patient.                                 □

   5. Once a decision to send blood has been made, inform the blood bank
      laboratory/On Call BMS. State:-
      • Patient information.
      • Expected time of transfer
      • Expected destination of patient.                               □

The laboratory staff on duty will pack the blood in a transit box with ice packs, enclose the
relevant paperwork (see form 2 below) and zip tie it closed.

Do not send for this boxed blood until the patient is ready to depart.

When the patient is ready to depart collect the blood box from the duty BMS.

   6. Take patient chart to blood bank and sign for units in the usual way. □

   7. When the patient and blood depart A&E, contact the Blood Bank/BMS on duty
      to confirm the destination.                          □

The BMS on duty will telephone the blood bank at the receiving hospital to give them patient
and unit details.

Date:
Time:
Signed:


                PLEASE PUT THIS FORM IN THE PATIENT’S NOTES




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 163 of 225
Transfusion Policy                                                         November 2005
Ref: PCD 032(v1)                                                       Status : Operational
Form 2
         BLOOD/BLOOD PRODUCTS TRANSFER FORM


    Please complete this form when transferring blood or blood products with a
                    patient to a second hospital for treatment




     Attach a copy report detailing full patient information
       including group, antibody status and any special
                         requirements
BLOOD DISPATCHED FROM:                         Hospital:
                                               Address:


                                               Telephone:
                                               Fax:

PACKED BY …………………….. AT …………. Hrs ON ……………….

           Details of units sent if not on or different from attached report form




 THE ENCLOSED UNITS OF BLOOD/BLOOD PRODUCTS MUST BE DELIVERED
           TO THE BLOOD BANK IMMEDIATELY ON ARRIVAL

                                              Notes

   1. The units of blood and or blood products detailed above or on the attached report
      have been stored in accordance with official guidelines until the date and time of
      packing as quoted.

   2. The receiving hospital (if providing further blood on site) must always obtain fresh
      sample taken on arrival to cover any further requirements for blood.

   3. Please inform the referring hospital of the eventual fate of the units received. This
       will enable a full audit trail of the units to be maintained.

RECEIVED BY …………………….. AT …………. Hrs ON ……………….




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 164 of 225
 Transfusion Policy                                         November 2005
 Ref: PCD 032(v1)                                       Status : Operational




         Transfusion Policy
            Appendix 22
Equipment used in the Administration of
                Blood


                      Date: November 2005

                      Ref : PCD 032 – A22

                      Vers : 1


       Policy Profile
       Policy Reference Number     PCD 032-A22
       Version                     1
       Status                      Operational
       Trust Lead                  L Delieu
       Implementation Date         November 2005
       Last Review Date
       Next Formal Review          July 2006
       Approval Record




 __________________________________________________________________________
 Dartford and Gravesham NHS Trust
 Hospital Transfusion Committee                             Page 165 of 225
Transfusion Policy                                               November 2005
Ref: PCD 032(v1)                                             Status : Operational


                              Transfusion Policy
                                  Appendix 22
             Equipment Used In the Administration of Blood Products




Contents


1.0     Introduction
2.0     Aims and Objectives
3.0     Scope
4.0     Equipment
4.1     Cannula
4.2     Blood Giving / Administration Sets
4.2.1   Table: List of components and relative giving set.
4.2.2   Priming the line
4.2.3   Changing the giving set
4.2.4   On completion of the Transfusion
4.2.5   Drugs
4.3     Electronic infusion pumps
4.4     Blood warmers
5.0     Pharmaceuticals and blood Transfusion
6.0     When the patient has limited venous access
7.0     References




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 166 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational

                              Transfusion Policy
                                  Appendix 22
             Equipment Used In the Administration of Blood Products

1.0 Introduction
This pertains to equipment used in the administration of blood products to adults and
children but not specifically for neonates. Please see Neonatal Policy if relevant.

2.0 Aims and Objectives
Clarification for those responsible for administration of blood products.

3.0 Scope
All staff involved in the transfusion process.

4.0 Equipment
4.1 Cannula

Select a cannula (with a Luer lock) – appropriate for product and flow rate required.

There is no minimum or maximum size but in general a 20 G (pink) is sufficient in routine
transfusions, although larger may be used.

The size chosen should depend on the size of vein and speed at which the blood is to be
transfused. e.g. Use large cannula for “massive transfusion”.

4.2 Blood Giving / Administration Sets
Filters are used to remove micro-aggregates (red cell debris, fibrin stands etc), which may
be present in the blood to be transfused.

It is essential that the correct administration set is used to transfuse each blood product.
Incorrect usage can affect administration.

Listed below are blood and blood products which are administered via giving sets alongside
the specific requirement of the type of set for each infusion.

All blood components in the UK (except Granulocytes) are leucocyte depleted within 48
hours of collection to minimise the theoretical risk of transmission of vCJD.

4.2.1 Table: List of components and relative giving set.
See end of document.

4.2.2 Priming the line
It is unnecessary to use any other intravenous fluid to prime the line, the intended blood and
blood products should be used, however 0.9% Saline may be used. Glucose should never
be used before or after blood as it causes pseudo agglutination.

For best results follow the method outlined below:
1 Use the roller to close the line.
2 Hold the bag inverted and spike the port.
3 Whilst inverted, use the roller to open the line.
4 Squeeze the bag gently to fill the filter chamber completely.
5 Continue until the second chamber is ½ full.
6 Close the line using the roller.
7 Turn the set the right way up.
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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 167 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
8 Continue to prime the set to the end of the line by opening the roller.
This method reduces frothing of the blood during priming. Completely covering the filter
excludes air, which can promote clot formation.

4.2.3 Changing the giving set
A new giving set should be at least every 12 hours to prevent bacterial growth (or after 2
units whichever is the sooner).

4.2.4 On completion of the Transfusion
Washing through the remainder of the blood in the line with saline (which holds approx.
30mls) is unnecessary.

4.2.5 Drugs
The BCSH guidelines state that ‘drugs must not be added to blood under any
circumstances’. (BCSH The Administration of blood and blood components and the
management of transfused patients 1999)

4.3 Electronic infusion pumps
Should not be used for the administration of blood unless they have been verified as safe for
this purpose according to the manufacturers instructions as they may damage blood cells.

4.4 Blood warmers
Blood should only be warmed using a specially designed commercial device with a visible
thermometer and audible warning.

Blood warmers can be dangerous and should only be used at the discretion of the doctor
prescribing the blood. The use of a blood warmer is often advised for:
   • Adults receiving infusion of blood at rates > 50ml/kg/hour.
   • Children receiving infusion of blood at rates > 15ml/kg/ hour.
   • Infants undergoing exchange transfusions
   • Transfusing a patient who has significant cold agglutinins

Blood warmers and giving sets are available on ITU and in theatre. If assistance is required
please contact ITU, critical care outreach team or on-call ODP.

Blood products must NOT be warmed by improvisations such as putting the pack into
hot water or on a radiator. Red cells and plasma exposed to temperatures over 40ºC
may cause severe transfusion reactions.

5.0 Pharmaceuticals and Blood Transfusion
Some intravenous drugs may interact with the citrate anticoagulant in blood, which is used to
prevent the blood clotting. Other drugs may be hyper-osmolar causing haemolysis of red
cells. Care should therefore be taken to avoid interactions between drugs and blood/blood
products.

No other infusion solutions or drugs should be added to any blood component.

If intravenous drugs need to be administered during transfusion it is recommended that
drugs be given through a separate line (or lumen of a central line). This is for instance
common in ITU.

Do not use 5% Dextrose via the same administration set as blood as this will cause
haemolysis of red cells.



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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 168 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational
Some drugs are needed to prevent adverse reactions to blood e.g. diuretic to prevent fluid
overload. Any drugs associated with the transfusion should be given as prescribed.
   • Other oral drugs can be given as normal at the prescribed time.
   • Consideration should be given to the drugs administered.

   •   Record drugs on the Integrated Care Pathway (ICP)

If in doubt, contact pharmacy for advice.

6.0 When the patient has limited venous access
Plan and considered when the timing of the transfusion.

Use at least 20mls of Normal Saline to flush lines and 3-way taps before or after blood
products when other drugs or fluids are to be administered.

For bolus or slow intravenous injections if there is no other access:

a) Before the transfusion is started attach a three way tap
b) Temporarily switch off the transfusion when drugs are due
c) Flush the line/cannula with normal saline.
d) Administer the intravenous drug
e) Flush the line again with normal saline
f) Restart the transfusion without delay
·
        For continuous infusions, if there is any doubt about the compatibility of the drug
with blood, seek advice from pharmacy.

7.0 References
For more information regarding the Practice of Transfusion of Blood and Blood Products please
consult the British Committee for Standards in Haematology Guidelines and your Hospital
Transfusion Policy.
The Royal College of Nursing has produced guidance ‘Right blood, right patient, right time’.
This publication (code 002 306) can be obtained free from RCN Direct and gives guidance
for improving transfusion practice.

Guidelines for the Blood Transfusion Services in the United Kingdom 6th Edition 2002 is also
a source of transfusion information and guidance.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 169 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
4.2.1 Table: List of components and relative giving set.
Component              Filter size             Comment
Red Cells.             170 – 200 micron filter • Gravity delivery is recommended.
Whole Blood.           is required (blood • Electronic infusion pumps should
Autologous Red         giving set)                 not      be     used      unless     the
Cells.                                             manufacturer verifies them as safe
                                                   for the purpose.
Platelets.             170 – 200 micron filter • Platelet concentrates should not be
                       is required (blood or       transfused through giving sets,
                       platelet giving set)        which have already been used for
                                                   blood.
FFP (Fresh Frozen 170 – 200 micron filter • Use within 4 hours if maintained at
Plasma)                is required (blood          22°C± 2°C or 24 hours if stored at
                       giving set)                 4°C (extended storage will result in
                                                   a decline in labile coagulation
                                                   factors).
Granulocytes           170 – 200 micron filter • The whole dose should be
                       is required (blood          transfused over 1-2 hours. No
                       giving set)                 supplemental filter should be used.
Cryoprecipitate        170 – 200 micron filter ● Use within 4 hours C (extended
                       is required (blood           storage will result in a decline in
                       giving set)             labile coagulation factors).
Human       Albumin Any intravenous (I.V.) • A 15 micron filter is recommended
Solution (HAS)         fluid giving set            but not mandatory
I.V. Immunoglobulin 15           micron filter • (A Codan set is supplied by The
                       vented giving set           manufacturer of Vigam)
Stem cells             Any intravenous (I.V.) • There is currently discussion on
                       fluid giving set            whether or not filters remove some
                                                   stem cells.
                                               • Current advice is to administer
                                                   through a normal I.V. fluid giving
                                                   set; there is no benefit in washing
                                                   out stem cell or granulocyte packs.
                                               • Many centres have however
                                                   successfully used blood-giving sets
                                                   for this procedure.




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 170 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




                       Transfusion Policy
                         Appendix 23
                     Administration of Blood
                       and Blood Products

                      Date:     November 2005

                      Ref :     PCD 032 – A23
                                (Formally CL004)

                      Vers :    2


      Policy Profile
      Policy Reference Number      PCD 032-A23 (formally CL004)
      Version                     2
      Status                      Operational
      Trust Lead                   Leslie Delieu
      Implementation Date         September 2005
      Last Review Date            June 2001
      Next Formal Review          September 2007
      Approval Record




__________________________________________________________________________
Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 171 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational

                                  Transfusion policy
                                    Appendix A23
                     Administration of Blood and Blood Products


CONTENTS

1.0    POLICY STATEMENT
2.0    SCOPE
3.0    INTRODUCTION
4.0    PRE-ADMINISTRATION PROCESSES
4.1    Patient information / consent
4.2    Requesting blood products
4.3    Blood samples
4.4    Blood bank records
4.5    Prescribing blood and blood products
4.6    Transfusion requests
4.7    Pre collection checks on the ward/clinical area.
4.8    Blood Collection Procedure
5.0    ADMINISTRATION OF BLOOD AND BLOOD PRODUCTS
5.1    Commencement of transfusion
5.2    Staff responsible for administration of blood products.
5.3    Checking procedures
5.4    Signing the compatibility form and prescription sheet.
5.5    Location of the blood transfusion compatibility report form
6.0    TECHNICAL ASPECTS OF THE ADMINISTRATION OF BLOOD RODUCTS
6.1    Cannula
6.2    Filters and Giving sets
6.3    Electronic infusion pumps
6.4    Blood Warmers
6.5    Pharmaceuticals and Blood Transfusion
6.6    Completing the transfusion
7.0    THE CARE AND MONITORING OF TRANSFUSED PATIENTS
7.1    Observations
7.2    Monitoring Unconscious Patients
8.0    THE MANAGEMENT AND REPORTING OF ADVERSE EVENTS
8.1    Recognising a reaction
8.2    Managing adverse events.
8.3    Reporting of adverse events
9.0    THE DOCUMENTATION OF TRANSFUSIONS
9.1    Medical notes
10.0   OUT-OF-HOSPITAL BLOOD TRANSFUSION




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 172 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
                                 Transfusion Policy
                                    Appendix A23
                     Administration of Blood and Blood Products

1.0 Policy Statement
This policy exists to ensure that all patients receiving blood and blood products do so in a
safe manner.

This policy should be read in conjunction with:
   • The Trust Transfusion Policy.
   • UKCC Code of Professional Conduct
   • UKCC Scope of Professional Practice.

2.0 Scope
This document relates primarily to the process of administration and should therefore be
read in conjunction with the Trust Transfusion Policy which covers all aspects of the
transfusion process. This document should be read by all healthcare workers involved in the
administration of blood components.

3.0 Introduction
The guidelines are based on British Committee for Standards in Haematology (BCSH),
Blood Transfusion Task Force Guidelines, a document which was produced in collaboration
with the Royal College of Nursing and the Royal College of Surgeons of England.

4.0 Pre-Administration Processes
Correct pre-administration processes are fundamental in ensuring safe transfusion practice.
For this reason each element is discussed in full, in the Trust Transfusion Policy and what is
written below is a brief outline.

4.1 Patient information / consent
Patients should be informed of the indication for blood transfusion, its risks and benefits and
alternatives. There are National Blood Service leaflets available in all clinical areas.

Consent should be sought and recorded in the patients’ notes. Patients have the right to
refuse transfusion.

4.2 Requesting blood products
Errors in requesting blood may result in failure to provide the correct type of blood
component, e.g. gamma-irradiated, CMV-sero-negative.

Other serious, yet common errors occur with patient identification, resulting in samples being
taken from the wrong patient.

See Transfusion Policy PCD 032-A8 for specific information on requesting blood products.

4.3 Blood samples
Samples must meet BCSH guideline standards for labelling or they will not be tested.

See Transfusion Policy PCD 032-A9 for information relating to samples required for blood
transfusion testing.

4.3.1 Sample labelling
Serious transfusion incidence may arise from the group and cross-match being performed
from a sample which is mislabelled.

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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 173 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational
See Transfusion PolicyPCD 032-A9 for specific guidelines on labelling transfusion samples.

4.4 Blood bank records
The blood bank staff should check the patients’ previous transfusion history, blood group or
for the presence of antibodies and any special requirements.

This task is hampered by the use of multiple hospital numbers for a patient. This will improve
in the future, once plans to use the patient’s NHS number as an identifier is in place.

The blood bank system will not be aware of transfusion episodes at another site so give
transfusion/obstetric history on the request form.

4.5 Prescribing blood and blood products
    • Prescribing blood products must be made by a doctor responsible for the patient.
    • The reason for the transfusion must be clearly documented.
    • The blood products required must be written on a prescription sheet for intravenous
       fluids.
    • The prescription sheet should contain the patient identification details (surname, first
       name, date of birth, hospital number and patient gender).
    • The prescription must specify:
            o the blood or blood component to be administered
            o any special requirements, e.g. gamma-irradiated, CMV-seronegative.
            o the quantity to be given.
            o the duration of the transfusion (usually 2 to 3 h for red cell concentrates, and
               30 min for an adult therapeutic dose of platelets or a unit of fresh frozen
               plasma)
            o any special instructions, e.g. any medication required before or during the
               transfusion

4.6 Transfusion requests
See Transfusion Policy 032-A8 for specific information relating to requesting blood products.

4.6.1 Telephone requests
Ensure you have all appropriate information to hand as the blood bank staff will require
information relating to the medic, the patient and the products required.

4.6.2 Written request form
The request form must be correctly competed including, details of the clinician, the patient,
the products required and the reason for transfusion.

4.6.3 Requesting of special blood requirements
Inform the blood bank of any special requirements.

Where they have been alerted to a patient’s special needs, the blood bank will take
responsibility for providing special blood products. e.g. gamma-irradiated for intrauterine
transfusions, selected products for patients requiring special blood or blood components on
a regular basis, e.g. haematology patients.

4.7 Pre-collection checks on the ward/clinical area.
To prevent wastage of blood and potential delay in infusion please check the following:
   • Patient consent to transfusion has been obtained and documented.
   • The reason for transfusion is clearly documented by a clinician in the patient’s notes.
   • A prescription, indicating the type of product, volume, infusion rate and required time
       for commencement is clearly documented by a clinician.


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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 174 of 225
Transfusion Policy                                                  November 2005
Ref: PCD 032(v1)                                                Status : Operational
   •   The patient’s care plan has been reviewed to ensure transfusion will not be delayed
       or interrupted.
   •   The patients’ pre transfusion observations have been checked and recorded. These
       include. Temperature. Pulse, Blood Pressure and Respiration.
   •   That there is venous access.
   •   There is sufficient staff available to ensure safe monitoring of the transfusion.
   •   The time and location of the transfusion allows for the safe monitoring of the patient.
           o Avoid transfusing at night.
           o Avoid transfusing patients in a side room – or you will need to perform
               increased number of observations.

4.8 Blood Collection Procedure
Withdrawal of blood and blood components from the storage location is a major source of
transfusion error therefore blood must only be collected by staff trained in this procedure.

Only remove one unit of blood at a time for each patient unless there is a medical
emergency requiring extremely rapid transfusion of large quantities of blood.

See Transfusion Policy 032-A21 for details on collecting blood or blood products.

5.0 ADMINISTRATION OF BLOOD AND BLOOD PRODUCTS
5.1 Commencement of transfusion
The transfusion of blood products should begin as soon as possible after delivery to the
clinical area.

If this is not possible, it should be returned to the blood bank with the time of return
documented.

If blood has been out of the refrigerator for more than 30 min and there is no prospect of its
imminent transfusion, inform the hospital blood bank. The product will be disposed by them
because of the risk of bacterial growth. Do not dispose of it on the ward as the blood bank
must, by law, document the fate of all blood products.

The transfusion of platelet concentrates and fresh frozen plasma should commence as soon
as possible to preserve the maximum activity of the platelets or coagulation factors.

5.2 Staff responsible for administration of blood products.
Blood products are a prescribed medicine and should only be administered by:
    • a doctor,
    • a nurse holding current registration of the UKCC Professional Register as a
        Registered General Nurse (RGN),
    • Registered Sick Children's Nurse (RSCN)
    • Registered Midwife (RM).

5.3 Checking procedures
Two nurses, one of whom is a Registered nurse are responsible for the pre-transfusion
checks of the blood product and the patient.

These checks must be completed at the patient’s bedside. The bedside check is a vital step
in preventing transfusion error.

5.3.1 Inspecting the blood product.
Checks would have been made by the blood bank staff prior to issue, but they should be
repeated on the ward.


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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 175 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
The unit should be checked / inspected for:
   • Expiry date (expiry dates are up to midnight).
   • The integrity of the pack - check for leaks at the ports and the seams.
   • Evidence of haemolysis.
   • Evidence of unusual discoloration, cloudness or
   • The presence of large clots.

N.B. Auxiliary nurses and HCAs must not check blood or blood products.

If there is evidence of any of the above, inform the blood bank and return the unit to a
member of blood bank staff.

5.3.2 Inspecting the blood bag label against the blood product.
Ensure the free hanging label has been attached to the correct unit of blood by checking the
12 digit blood donation number on the unit against the number printed on the label.

If this does not match inform the blood bank and return the unit to a member of blood bank
staff

5.3.3 Check the patient against the prescription chart.
Positively identity the patient by asking them their name and date of birth, and check this
verbal information against their wristband.

DO NOT transfuse patients unless they are wearing a wristband which bears the correct
patient details..

Check the patients’ wristband information against the prescription chart and notes. Check:
   • Full name
   • Date of birth
   • Hospital Number
   • Gender
   • Special requirements. e.g. gamma-irradiated, CMV-seronegative

DO NOT transfuse if this information is incorrect, incomplete or mismatched.

Checking the wristband is especially important when the patient is unconscious.

5.3.4 Check the patient information against the blood bag label and compatibility
sheet.
Check the patients’ prescription & wristband information against the compatibility sheet and
the free hanging label attached to the blood product. Check:
    • Full name
    • Date of birth
    • Hospital Number
    • Gender
    • Expiry date
    • Blood bag unit number
    • Blood group

5.3.5 Check the blood group
The blood group and unit number on the unit of blood product must be identical to that on
the blood transfusion compatibility report form.

The blood group on the unit must be compatible with the blood group of the patient, as
indicated on the compatibility form and label attached to the blood pack.
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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 176 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational

If the blood group of the unit and the patient are not identical the blood bank should have
made a specific comment on the blood bag label to indicate that the blood is suitable for
transfusion.

If there are any discrepancies contact the blood bank. Also see appendix 11.

5.4 Signing the compatibility form and prescription sheet.

If all the information is correct, those performing the checks must:
     • Sign the prescription chart. Record the start and stop time.
     • Sign the compatibility form – against the unit being transfused,. Record start/stop
          time. In the near future this will be superseded by the I.C.P.
     • Peel off the detachable sticky label on the free hanging bag label and put this in the
          notes. In the near future this will be put in the I.C.P.

Record the start time and stop time of each unit.

5.5 Location of the blood transfusion compatibility report form
The blood transfusion compatibility report form must be readily available during the
transfusion, until the transfusion is complete.

The ideal location may vary from one clinical area to another but is ideally kept at the
patients bedside.

When the transfusion is completed this form must be fixed in the patient's medical
notes as a permanent record of the transfusion. By law this will be kept for 30 years.
In the near future this will be put in the I.C.P.

6.0 Technical Aspects Of The Administration Of Blood Products
6.1 Cannula
There is no minimum or maximum size of cannula for transfusion.
The size of the cannula will depend on the size of the vein and the speed at which the blood
is to be transfused.

6.2 Filters and Giving sets
See transfusion policy 032-A22

   •   Red blood cell, Fresh Frozen Plasma and Cryoprecipitate should be transfused
       through a sterile 170-micron filter, giving set designed for the procedure.
   •   Platelet products and cryoprecipitate should be transfused through a platelet
       administration set which will be issued by the blood bank with the units.
   •   Albumin may be transfused through a standard giving set.

   •   Do not transfuse platelets through a filter already used for blood.
   •   Change the giving set after 2 units of blood have been transfused.
   •   Change the giving set after 12 hours, to prevent bacterial growth.
   •   Discard giving set upon discontinuation or completion of transfusion

Special paediatric giving sets should be used for transfusions to infants, or a screen filter
used if the transfusion is being administered by syringe. See Paediatric Policy.




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 177 of 225
Transfusion Policy                                                   November 2005
Ref: PCD 032(v1)                                                 Status : Operational
Calculate drip rate as

              Volume          X    Drops per ml      = drops per minute
          Prescribed hours              60

6.3 Electronic infusion pumps
These may cause damage to blood cells, and should not be used for the administration of
red cells unless they have been verified as safe to use for this purpose.

6.4 Blood Warmers
Blood should only be warmed using a specifically designed commercial device with a visible
thermometer and audible warning;

DO NOT warm blood components using improvisations such as putting the pack into hot
water, in a microwave or on a radiator.



A blood warmer is indicated with transfusion rates :
    • > 50mL kg/hour in adults,
    • > 15mL kg/hour in children.
    • For exchange transfusions in infants.
    • When transfusing patients with clinically significant cold agglutinins.

6.5 Pharmaceuticals and Blood Transfusion
Some intravenous drugs may interact with the citrate anticoagulant in blood, which is used to
prevent the blood clotting. Other drugs may be hyper-osmolar causing haemolysis of red
cells. Care should therefore be taken to avoid interactions between drugs and blood/blood
products.

No other infusion solutions or drugs should be added to any blood component.

If intravenous drugs need to be administered during transfusion it is recommended that
drugs be given through a separate line (or lumen of a central line). This is for instance
common in ITU.

Do not use 5% Dextrose via the same administration set as blood as this will cause
haemolysis of red cells.

Some drugs are needed to prevent adverse reactions to blood e.g. diuretic to prevent fluid
overload. Any drugs associated with the transfusion should be given as prescribed.
   • Other oral drugs can be given as normal at the prescribed time.
   • Consideration should be given to the drugs administered.

   •   Record drugs on the Integrated Care Pathway (ICP)

If in doubt, contact pharmacy for advice.

6.6 Completing the transfusion
    • Seal ports on empty bags.
    • Discarded the giving set according to the hospital policy for disposing of clinical
      waste.
    • Send the empty blood bags back to the blood bank, so that they are available for
      testing if a severe transfusion reaction occurs some hours after discontinuation of the
      transfusion.
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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 178 of 225
Transfusion Policy                                                     November 2005
Ref: PCD 032(v1)                                                   Status : Operational

Ensure the blood transfusion compatibility report form should is filed in the patient's notes.

7.0 The Care And Monitoring Of Transfused Patients
Patients receiving transfusions should be monitored for signs of the potential
complications of transfusion and any suspected problems must be dealt quickly.

7.1 Observations
Visual observation of the patient is often the best way of assessing patients during
transfusion. Transfusions should be administered in clinical areas where patients can be
readily observed by members of the clinical staff.

Severe reactions are most likely to occur within the first 15 minutes of the start of each unit,
and patients should be most closely observed during this period.

Observations should be checked and recorded:
   • Within 15 minutes before starting the transfusion.
   • Within 15 minutes after starting the transfusion.
   • At the end of the transfusion.

Observations may be required more frequently during the transfusion if:

       •   The patient becomes unwell.
       •   The patient has a history of adverse events.
       •   The patient has allergies.
       •   The patient has antibodies.
       •   The patient is unconscious or unable to speak.
       •   The patient is in a side room or not easily observed from the nursing station.
       •   The patient is alone in a treatment area.
       •   The transfusion is being conducted at night when the patient is asleep.

Record transfusion start / stop times and the times of every observation.

Each time record the patients’
   • temperature,
   • pulse
   • blood pressure.

Vital signs related to transfusion should be recorded separately from routine observations
and clearly dated to enable the information to be retrieved later, if necessary.

7.2 Monitoring unconscious patients
This usually relates to patients in theatre, ITU or A&E (and neonates).

These patients are more difficult to monitor for signs of transfusion reactions.
Routine observation patterns should continue.
Transfusion reactions should be considered when assessing a change or deterioration in the
patient's condition, particularly during the first 15 min following the start of a unit of blood or
blood component.

The first signs of acute haemolytic transfusion reaction may be:
   • Hypotension,
   • uncontrolled bleeding due to disseminated intravascular coagulation,
   • haemoglobinuria or oliguria

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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 179 of 225
Transfusion Policy                                                 November 2005
Ref: PCD 032(v1)                                               Status : Operational
8.0 The Management and Reporting Of Adverse Events
8.1 Recognising a reaction

Serious adverse event are generally unpredictable. It is therefore important that staff
monitoring patients are aware of the symptoms of transfusion reaction.
See transfusion policy 032-A24 Adverse Reactions and Events.

In addition, patients informed of the possible adverse effects of transfusion should be
encouraged to report any problems.

The most important are acute and delayed haemolytic transfusion reactions,
febrile (nonhaemolytic) transfusion reactions, urticaria and anaphylaxis, transfusion-related
acute lung injury (TRALI), post-transfusion purpura (PTP), transfusionassociated, graft-vs.-
host disease (TA-GvHD)

Symptoms include including
   • change in observations
   • shivering
   • rashes,
   • flushing,
   • shortness of breath,
   • pain in extremities or in the loins.

8.2 Management.
    • Stop the transfusion
    • Contact the medical staff
    • Repeat observations

Further management depends on the type and severity of the reaction.
See transfusion policy 032-A24 for more comprehensive advise.

If a severe reaction is suspected:
     • Discontinue the transfusion
     • Maintain venous access with normal saline.
     • Seek urgent medical advice
     • Change the blood administration set. It will be required by blood bank.
     • Report reaction to the blood bank, who will request the return of the implicated unit
        and further blood samples from the patient including.
            o Group and Save.
            o FBC
            o Clotting screen
            o U&E
            o Blood Culture
            o Urine for Urobilinogen
     • Carry out nursing observations at regular intervals – depending on symptoms.
     • Maintain a fluid balance chart.
     • Record the volume and colour of any urine

8.3 Reporting of adverse events
See transfusion policy 032-A24

   •   All adverse events related to blood transfusion should be reported to the blood bank
       in the first instance.
   •   If a severe reaction is suspected, contact the Consultant Haematologist for advise.

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   •   Adverse events related to blood transfusion will be reviewed by the Hospital
       Transfusion Team and reported to the Hospital Transfusion Committee and where
       necessary to SHOT and MHRA.
   •   Serious non-infectious adverse events (incorrect blood or blood component
       transfused, acute and delayed transfusion reactions including anaphylaxis, TA-
       GvHD, TRALI, PTP) should be reported to the SHOT scheme.
   •   Suspected cases of transfusion-transmitted infection will be reported to the local
       Transfusion Centre

9.0 The Documentation of Transfusions
It a requirement by law that all transfusion documentation be retained for 30 years.

Blood products should be able to be tracked “vein to vein”, that is, from donor to recipient or
disposal.

Also good documentation is essential for the investigation of adverse events and for the
purpose of audit.

9.1 Medical notes
A permanent record of the transfusion of blood and blood components and their
administration must be kept in the medical notes including:
     • the blood transfusion compatibility report form.
     • the prescription.
     • the nursing observations.
     • the indication for the use of blood or blood components, the date, the number and
        type used, whether or not it achieved the desired effect and the occurrence and
        management of any adverse effects.
By the end of 2005 this documentation will be superseded by the Transfusion Integrated
Care Pathway. The ICP will be used to record the whole transfusion Process. It will be
returned to the blood bank laboratory. Blood bank staff will be custodians of this information
for 30 years,

10.0 Out-Of-Hospital Blood Transfusion
Currently there are no community transfusion being carried out within the Trust.




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Hospital Transfusion Committee                             Page 181 of 225
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Ref: PCD 032(v1)                                       Status : Operational




              Transfusion Policy
                 Appendix 24
         Adverse Reactions and Events



                     Date: November 2005

                     Ref : PCD 032 – A24

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032-A24
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 182 of 225
Transfusion Policy                                               November 2005
Ref: PCD 032(v1)                                             Status : Operational


                                Transfusion Policy
                                   Appendix 24
                           Adverse Reactions and Events

CONTENTS

1.0    Introduction
2.0    Aim and Objectives
3.0    Scope
4.0    Signs and Symptoms
5.0    Causes of transfusion reaction
6.0    Management of Acute Transfusion reactions.
7.0    List of Acute Transfusion Reactions
7.1    Acute intravascular haemolysis of transfused red cells
7.2    Infective shock
7.3    Non haemolytic febrile transfusion reaction
7.4    Severe Allergic Reaction
7.5    Urticaria/itching
7.6    Anaphylaxis
7.6    Transfusion Related Acute Lung Injury (TRALI)
7.7    Delayed Transfusion Reactions
7.8    Post Transfusion Purpura
7.9    Transfusion related graft-versus-host disease
7.10   Transfusion Transmitted Infection/disease
7.11   Iron Overload
7.12   Fluid overload
8.0    Minor reactions
9.0    Investigation of an Acute Severe Reaction
9.1    Pathology tests.
9.2    On the ward
10.0   The Patients role in reporting adverse events
10.1   Out Patients or Patients discharged after transfusions.
10.2   Unconscious Patients / Patients unable to Communicate.
11.0   What to do with the product after transfusion reaction.
12.0   Documentation
13.0   Other Events and near misses
14.0   Reporting of Incidents

15.0 FORM Investigation of Apparent Blood and Blood Products Transfusion Reaction
16.0 FLOW CHART Management of Severe Acute Reaction.




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Hospital Transfusion Committee                             Page 183 of 225
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Ref: PCD 032(v1)                                                     Status : Operational
                                   Transfusion Policy
                                      Appendix 24
                              Adverse Reactions and Events

      FOR URGENT INFORMATION GO TO LAST PAGE FOR FLOW CHART
                “Management of Severe Acute Reaction”

1.0 Introduction
Occasionally some patients experience a reaction due to the transfusion, and occasionally
the transfusion process breaks down which results in an adverse event.
If reactions occur during transfusion, the following will give guidance on the appropriate
course of action:

It is essential that, however mild or severe the event or reaction, the incident is
reported.

2.0 Aim and Objectives
This appendix can be used in staff training and as resource of information for patient
management in a real event.

3.0 Scope
All staff involved in the transfusion process, particularly for those with direct responsibility for
the care of patients being transfused. The patient’s too can help. A well informed patient can
bring a problem to the attention to nursing staff.

4.0 Signs and Symptoms
The first step in safe patient management is to be familiar with the many Symptoms and
Clinical Features associated with transfusion reactions.

The most serious reaction is an ABO incompatible transfusion. These are rare, and usually
occur because of a clerical / checking error / laboratory error.

4.1.1 Table 1 Signs and symptoms

Symptoms                                          Clinical features
Apprehension                                      Fever and/or rigors
Agitation                                         Bronchospasm
Flushing                                          Pulmonary oedema
Itching                                           Hypotension
Pain at venepuncture site                         Anaphylaxis
Pain in abdomen, flank or chest                   Liver or renal failure
Cough                                             Haemaglobinuria
Shortness of breath                               Haemoglobinaemia
                                                  Generalised oozing from wound or
                                                  puncture site

5.0 Causes of transfusion reaction
Transfusion reactions may be acute, i.e. occurring less than 24 hours after transfusion, or
delayed, i.e. occurring after 24 hours, and they may vary in severity.




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Hospital Transfusion Committee                             Page 184 of 225
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  5.1 Acute Reactions <24hrs
Reaction                                   Usual cause
Haemolytic TR               Uncommon       ABO incompatibility
Febrile nonhaemolytic TR      Common       Cytokines, anti-leucocyte antibody
Allergic TR                 Uncommon       Antibodies to plasma proteins
Anaphylaxis TR              Uncommon       Antibodies to IgA
TRALI                            Rare      Antibodies to leucocytes
Marked fever with septic shock   Rare      Bacterial contamination
Congestive heart failure      Common       Volume overload
Air embolism                     Rare      Air infusion via line
Hypocalcaemia               Uncommon       Citrate toxicity
Hypothermia                 Uncommon       Rapid infusion of cold blood
Hyper kalaemia             Uncommon        Red cell storage

 5.2 Delayed Reaction >24
Reaction                                   Usual cause
Haemolytic              Uncommon           Development of a red cell antibody
GvHD                         Rare          Engraftment of transfused functional
                                           lymphocytes
Post transfusion purpura            Rare   Anti-platelet antibodies
Iron overload                              Multiple Transfusions
Transfusion transmitted disease            e.g. HIV, Hepatitis, vCJD, HTLV etc


 6.0 Management of Acute Transfusion reactions.
 Severe reactions are uncommon but life threatening and must be managed quickly.

 In brief, it is suggested that:-

     •   Stop the transfusion.
     •   Inform the doctor at once.
     •   Keep the cannula in place, renew the infusion line and keep vein open with a
         suitable solution (0.9% sodium chloride).
     •   Reconfirm the patient’s identity to check that the patient has received the correct
         product.

     •   If a mistake is apparent, inform the Blood Bank at once, as another
         patient may be involved in the same incident.

 6.1 Unconscious patients
 These patients are often difficult to assess and transfusion reactions should always be
 considered if there is a change or deterioration in the patient’s condition.

     •   Hypotension,
     •   Uncontrolled bleeding due to disseminated intravascular coagulation (DIC),
     •   haemoglobinuria or oliguria may be the first indication of an acute haemolytic
         transfusion reaction.

 7.0 List of Acute Transfusion Reactions
 These are the more serious types of reaction, and should be reported to the Consultant
 Haematologist and Blood Bank, who will inform the Transfusion Practitioner.




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 Hospital Transfusion Committee                             Page 185 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
7.1 Acute intravascular haemolysis of transfused red cells
Onset is often seen within a few minutes of starting the transfusion. It is usually due to ABO
incompatibility or other compliment fixing antibodies. Mortality due to DIC and acute renal
failure is seen in 10% of cases. Symptoms include:
     • Pain,
     • flushing,
     • Shock,
     • haemorrhage, (DIC)
     • oliguria,
     • haemoglobinuria etc

Management is supportive. The doctor may consider transferring the patient to ITU.
The ward should seek expert advice dependant on the patient’s condition. Management may
include the following or similar treatment:-

   •   Maintain blood pressure
          o If necessary give IV fluids
          o If red cells are required use re-crossmatched blood.
   •   Maintain renal perfusion.
          o Insert bladder catheter and monitor urine output.
          o If urine output <15m//Kg/hr. insert CVP line and give fluid challenge.
          o If still < 15m//Kg/hr and CVP adequate give Frusemide 80-120mg
          o If no diuresis follows Fruemide give mannitol 20% 100ml IV
          o If urine output 2hrs after Frusemide and Mannitol is < 1.5ml/Kg/hr.

   •   Perform ECG and check for evidence of hyperkalaemia.
            o If plasma potassium rises >6.0mmol/L give 50ml 50% glucose IV with 10 units
               insulin IV.
            o Follow with IV infusion of 10% glucose containing 10 units insulin over 4
               hours.
            o Resonium A may be needed to control K+
   •   Treat DIC as indicated.
   •   If prescribed, administer Hydrocortisone 100mg iv and Chlorpheniramine (Piriton)
       10mg + Parcecetamol.

The patient will need laboratory investigations. See Section 9.

Avoid by prevention of administrative errors

7.2 Infective shock
This may be indistinguishable from acute haemolytic transfusion reaction.
It is usually due to bacterial endotoxins due from bacterial contamination e.g. with
Pseudomonas, Yersinia, Staphylococci.
It can be implicated with any blood product, but more commonly with platelets (stored at
room temp) or plasma (thawed in a water bath)

The product may look cloudy or have “clumps”.

The patients septicaemia should be treated with broad spectrum antibiotics and manage as
above 7.1

7.3 Non haemolytic febrile transfusion reaction
This usually occurs towards the end or within a few hours of completing the transfusion.
It is usually due to antibodies to transfused white cells, as such it is less common since the
introduction of universal leucodepleted. Symptoms
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   •   Temperature,
   •   tachycardia,
   •    rigors etc
   •   (do not usually develop hypotension).

Stop or slow transfusion. Give Paracetamol or other antipyretic if indicated
Transfusion may be continued if there is no progression of symptoms after 30 mins.
If persistent reactions contact Consultant Haematologist as investigation may be required.

7.4 Severe Allergic Reaction
An allergic reaction may be due to a number of reasons e.g. antibodies reacting to allergens
(plasma proteins) or to inflammatory cytokines release from platelets during storage.
Symptoms:
    • itching
    • Pruritis
    • Tachycardia
    • skin rash often with wheals.
    • Bronchospasm
    • Cough /wheezing
    • Angioedema (often of eyes, lips, tongue).

The transfusion should be stopped. Management of the patient may require:

   •   Oxygen
   •   Chloropheniramine 10mg slowly IV
   •   Hydrocortisone 100-200.Mg IV
   •   If respiratory symptoms or history of asthma give Salbutamol nebuliser

7.6 Anaphylaxis
Is a rare but potentially life threatening risk of transfusion. Symptoms include.
     • Hypotension,
     • tachycardia,
     • fever,
     • bronchospasm

Often the cause is unknown. Occasionally investigations show it is due to severe IgA
deficiency with anti IgA antibodies.

Expert medical advice should be sought. Management will be based on local protocols but
will generally be similar to the following.
     • Stop the transfusion.
     • Maintain airway and give oxygen.
     • Give adrenaline 0.5-1.0mg i.m. repeated every 10 mins according to BP and HR in
        the absence of clinical improvement or if deterioration occurs after initial treatment.
     • If no clinical improvement call the cardiac arrest team.
     • Give Chlorpheniramine 10 –20 mg by slow iv injection.
     • Give Hydrocortisone 100mg iv
     • Give Salbutamol by nebuliser.
     • If symptoms of shock do not respond to drugs give IV fluid
     • Contact the duty anaesthetist and Consultant Haematologist
     • Follow basic life support if patient suffers respiratory or cardio-respiratory distress.
     • ECG if clinically indicated or in the presence of hyperkalaemia

Contact the Consultant Haematologist who will advise on investigations.
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Hospital Transfusion Committee                             Page 187 of 225
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If the recipient is known to be (or found to be) IgA deficient seek advice before transfusing.
IgA deficient / washed products are available from the National Blood Service.

7.6 Urticaria/itching
Frequency 2% of transfusions. Usually due to antibodies reacting to allergens (plasma
proteins) in transfused plasma, therefore more commonly associated with FFP and Platelets.
Reaction may be delayed 2-3 hours after transfusion. There may be a spectrum of severity
from mild to severe:

Symptoms may vary from :
    • Mild itching
    to
    • skin rash often with wheals.
    • Bronchospasm
    • anaphylaxis
In cases with mild symptoms
    • Stop or slow transfusion.
    • Give Chlorpheniramine 10mg slowly IV/IM
    • Transfusion may be continued if there is no progression of symptoms after 30 mins.

Pre-medicate with chlorpheniramine 4- 8mg orally or 10-20mg IV before transfusion for
patients having recurrent episodes. I

If mild symptoms persist or if the patient has had a more serious reaction contact
Haematologist for advice.

7.6 Transfusion Related Acute Lung Injury (TRALI)
Due to donor plasma having antibody to patient leucocytes. Symptoms:
    • Acute dyspnoea with hypoxia and bilateral pulmonary infiltrates occurring during
       within 24 hours (usually < 6 hrs) after transfusion, with no other apparent cause.

Give respiratory support, diuretics and high dose steroids.
Treat as ARDS – ventilate if hypoxia indicates.

Exclude other causes of ARDS. Report to National Blood Service via Blood Bank for
investigation of the donors involved.

7.7 Delayed Transfusion Reactions
These reactions may occur more than 24 hours (usually 5-10 days) after the transfusion due
to non- compliment fixing red cell antibodies formed after previous red cell transfusions/
pregnancies. This further transfusion has caused a secondary immune response resulting
cell destruction. This will require management and investigation.
Symptoms;
    • Falling haemoglobin,
    • Jaundice
    • Back (kidney) pain

Investigate cause of jaundice:
    • Chemistry, urine for urobilinogen
    • Chemistry, for raised conjugated bilirubin.
    • Transfusion for Direct antiglobulin test antibody screen.
    • Haematology for Hb and spherocytes on blood film.

The blood bank laboratory will perform antibody investigations. Further transfusion may
require the provision of selected blood.
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Hospital Transfusion Committee                             Page 188 of 225
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7.8 Post Transfusion Purpura (PTP)
PTP is rare, occurring 5-12 days post transfusion. Thrombocytopenia, often associated with
bleeding and poor response to platelet transfusion. More common in parous women.

Due to boosting of preformed anti platelet antibodies. Patients own platelets are
Destroyed, probably as ‘innocent bystanders’ . Patients usually HPA1a negative with
antiHPA1a antibodies.

Symptoms:
  • Marked thrombocytopenia arising 5-12 days post transfusion.


Seek advice from Consultant Haematologist.

   •    Treat with steroids and IV immunoglobulin.

N.B. Transfusion is contra indicated so avoid blood products if possible.
If required give appropriate platelets e.g. HPA1a negative.
Give blood that is HPA -matched if available. If not, leucocyte-depletion removes platelets so
normal units can be given.

7.9 Transfusion related graft-versus-host disease (TR-GvHD)
TR-GvHD is very rare but is associated with 100% mortality. It is caused by transfused donor
T lymphocytes engrafting in the host because they are severely Immuno-compromised or
they are partially HLA matched (shared haplotype). The lymphocytes then recognise the
patient as ‘foreign’.

Classically symptoms develop 1-6 weeks following transfusion, without other apparent
cause.

    •   fever,
    •   rash,
    •   liver dysfunction,
    •   diarrhoea and
    •    pancytopenia

Immunosuppressive treatment as for other graft versus host disease..Diagnosis usually
supported by skin/bone marrow biopsy + cytogenetic or HLA analysis to establish presence
of third party lymphocytes.

Prevented by transfusion of gamma-irradiated products to high risk patients.

7.10 Transfusion Transmitted Infection/disease
Symptoms depend on the infection/disease transmitted. Often silent and may take weeks,
month or years to manifest.

Treat the disease.

Inform Blood Bank who will contact transfusion centre urgently to trace the donor.

N.B. Currently the Government is make ex-gratia payments starting at £20,000 for patients
contracting HIV or Hepatitis C from a blood transfusion (proven).



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Hospital Transfusion Committee                             Page 189 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
7.11 Iron Overload
Each unit contains about 250mg of iron which cannot be excreted. Can cause cardiac,
hepatic impairment etc . Often a problem to patients undergoing multiple transfusion over
several years e.g. haemoglobinopathies.

Desferral (desferrioxamine) is use to chelate excess iron and to increase iron excretion.

7.12 Fluid overload
May be mistaken for TRALI when acute respiratory distress occurs shortly after transfusion.
Raised CVP indicates fluid overload. This may be managed by stopping the infusion and
treating with Oxygen and Frusemide.

8.0 Minor reactions
Minor reactions are not uncommon, but are less frequent since the advent of leucodepleted
blood products.

The occurrence of itching, urticaria or mild fever (increased by 1oC) in isolation indicates a
probable minor reaction. They are more common during platelet or plasma transfusions.

8.1 Minor reactions – management.
The transfusion should be slowed or stopped for about 30 minutes. The clinician may
consider using:
     • Paracetamol 1g,
     • Hydrocortisone 100mg and/or chlorpheniramine 10mg
If symptoms and observations normalise the transfusion can be restarted.

If symptoms recur once the transfusion is restarted, it should be stopped and taken down,
and the nurse in charge and doctor informed. The patient’s temperature, pulse and blood
pressure should be recorded. The procedure should then be followed as for a severe
reaction.

Record the reaction, management, and response in the clinical notes.

9.0 Investigation of an Acute Severe Reaction

9.1 Pathology tests.
Test will be required to establish the type and severity of the reaction, and help with patient
management.

Inform the blood bank laboratory or the On-call Haematology BMS and the on-call
Consultant Haematologist. The following samples will be required:

   •   2 x 6ml EDTA samples in a pink topped “crossmatch” samples.
   •   1 x 1.8 ml Sodium citrate, blue top sample.
   •   1 x 6 ml Plain tube, orange top sample
   •   Urine sample
   •   Remains of donor pack causing the reaction including the giving set.
   •   Any empty bags containing blood transfused within previous 48 hours.

   Also
    • Blood culture samples – if infected unit is suspected.

   Order the following tests
   • Full blood count and coagulation screen.
   • Urea, Creatinine, Electrolytes, Liver function tests.
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Hospital Transfusion Committee                             Page 190 of 225
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Ref: PCD 032(v1)                                                   Status : Operational
   •   Blood cultures.
   •   Urine for haemoglobinuria.
   •   Serum for methaemalbumin and haptoglobin if acute haemolytic reaction is
       suspected.
N.B. Incorrectly labelled samples and/or inadequately completed forms WILL delay results.

9.2 – On the ward
    • Monitor urine output and consider catheterization.
    • Test a sample of urine with a multistix for evidence of haemoglobinuria.
    • Do an ECG and check for evidence of hyperkalaemia

10.0 The Patients role in reporting adverse events
Prior to transfusion the patient should be instructed to advise staff if they notice any
untoward symptoms, as listed below.

   •   Feeling that “something is wrong” or being unwell in any way
   •   Flushing feeling hot and bothered.
   •   Acute rash.
   •   Shivering and shaking.
   •   Progressive agitation.
   •   Pain at the cannula site.
   •   Shortness of breath.
   •   Acute diarrhea or sudden vomiting.
   •   Severe pain, especially in the loin/lower back, abdomen or chest.
   •   Passing red urine.

10.1 Out Patients or Patients discharged after transfusions.
Any patients who are being treated as a day case or being discharged soon after being
transfused must be instructed that if they notice any of the above symptoms after getting
home they should immediately contact the place where the transfusion took place. IF they
are unable to contact the clinical unit, they can seek help from their General Practitioner.

10.2 Unconscious Patients / Patients unable to Communicate.
These patients cannot tell a health care person they have a problem. They may be difficult to
assess, therefore it is imperative that observations are preformed at regular intervals. Any
changes in the observations, especially hypotension, tachycardia, or pyrexia are acted upon.
Remember, uncontrolled bleeding (DIC) and haemaoglobinuria may be the first indication of
an acute haemolytic transfusion reaction.

11.0 What to do with the product after transfusion reaction.
Blood products implicated in a transfusion reaction should be removed from the patient
together with the giving set.

Do not dispose of the used component or giving set unless advised to do so by the Blood
Bank Laboratory.

The giving set and any other open ports should be sealed before sending the unit to the
Blood Bank for investigation, placed in a plastic bag with a brief note of what has occurred.

12.0 Documentation
   • All details of the reaction, treatment and investigations must be documented.

13.0 Other Events and near misses

It is quite possible for adverse events and near misses occur without “harming” the patient.
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Hospital Transfusion Committee                             Page 191 of 225
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Ref: PCD 032(v1)                                                  Status : Operational

For example
   • A patient group A who is transfused blood group O intended for another patient.
   • An immuno-compromised patient may be transfused un-irradiated blood
   • A collection error is discovered by staff doing the bed-side check.
   • A mislabelled sample is discovered because of a historic result.

Although they have not cause harm, they are reportable adverse events.
Investigation of such events will uncover failures in the process or highlight training issues.
Do not ignore them.

14.0 Reporting of Incidents
Any unexpected event that has an actual or potential short-term or long-term detrimental
effect on an individual patient or member of staff must be reported according to the Trust’s
Guidelines for Adverse Incident Reporting (Sent to risk management team) and to the Blood
Bank Laboratory.

Incident reporting should include ‘near miss’ episodes involving procedural errors which
were detected in time to prevent a serious complication of blood transfusion, e.g. taking the
blood sample for compatibility testing from the wrong patient or labeling the blood sample
with another patient’s details.

The blood bank will ensure the incident:-
Does not indirectly affect another patient,
Is recorded on TPath if necessary,
Is passed to the Specialist Practitioner of Transfusion for Investigation and reporting.

The S.P.o.T. or Consultant Haematologist must report all suspected transfusion-transmitted
infections and TRALI to the National Blood Service.

The Hospital Transfusion Committee (HTC) will review all transfusion-related
reactions and adverse events.

   •   What happened.
   •   Were any procedures breached.
   •   How could this be prevented in the future.
   •   What action is appropriate

The Hospital Transfusion Team will report the event to ‘Serious Hazards of Transfusion’
(SHOT) and where necessary, to the MHRA.




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Hospital Transfusion Committee                             Page 192 of 225
Transfusion Policy                                                                       November 2005
Ref: PCD 032(v1)                                                                     Status : Operational

FORM

              INVESTIGATION OF APPARENT BLOOD AND BLOOD PRODUCTS TRANSFUSION REACTION

PATIENT DETAILS:-
FULL NAME                                                          HOSPITAL NO:-

CONSULTANT:-                                                       WARD:-
BLOOD GROUP:-

REQUIREMENTS:-
1) Donor pack causing reaction, complete with giving set.
2) 4ml EDTA ( purple cap bottle) for FBC and Platelets count.
3) 6 ml EDTA ( pink cap bottle) for transfusion reaction, repeat compatibility and DAT.
4) 4 ml sodium citrate tube (blue cap bottle) for Coagulation screen.
5) 6 ml plain tube (orange cap bottle) for U&E , LTF
6) Blood culture set .
7) First available MSU for chemistry urine analysis.

       TO BE COMPLETED IN BY THE MEDICAL OFFICER RESPONSIBLE FOR THE PATIENT

A. THE PATIENT (Brief synopsis of history prior to transfusion):
Transfusion history


Reason for transfusion                                                      Pre-transfusion Hb:-

Symptoms of reaction observed:- Please tick as applicable:-

Pyrexia [ ]     Rigor [ ] Lumbar Pain [ ]         Rash [ ]        Hypotension [ ]        Tachycardia [ ]

Haemoglobinuria [ ]        Vomiting [ ]        Jaundice [ ]           Oliguria / Anuria [ ]

Volume of urine passed since reaction:-

Female patients:-           No of Pregnancies:-                         Abortions/Miscarriages:-

                            Atypical Antibodies:-                       Previous transfusion reaction:-

B. THE BLOOD PACK
GROUP:-                              UNIT NUMBER:-
EXPIRY DATE:-

Date and time taken from blood bank:-

Was blood warmed before transfusion?                     If yes, Please give details:-

Time infusion commenced:-

Number of units of blood infused through giving set:-

Was anything injected or added into the pack or giving set?                 Yes [    ]    No [     ]
If yes, please give details:-

Date and time of reaction:-

Signed:=_________________________________                      Name:-

________________________________

Updated:- Sept 2005 (Return completed form to the lab. with Remaining Blood pack and Giving set.

Handbook of Transfusion Medicine: Blood Transfusion Services of the United Kingdom, Third Edition; Stationary Office; 2001




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Hospital Transfusion Committee                             Page 193 of 225
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           Ref: PCD 032(v1)                                       Status : Operational
           FLOW CHART


NB: Pink urine can
be an indicator of
haemoglobinuria
following severe
haemolytic reaction




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           Dartford and Gravesham NHS Trust
           Hospital Transfusion Committee                             Page 194 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




           Transfusion Policy
              Appendix 25
      Neonatal Transfusion Policy
  Including use of Paediatric Products

                     Date: November 2005

                     Ref : PCD 032 – A25

                     Vers : 1

      Policy Profile
      Policy Reference Number     PDC 032-A25
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 195 of 225
Transfusion Policy                                                         November 2005
Ref: PCD 032(v1)                                                       Status : Operational
CONTENTS
1.0  Introduction
2.0  Aims and Objectives
3.0  Scope
4.0  Paediatric blood products.
5.0  Consent
6.0  Prescribing
6.1  Reason for Transfusion
6.2  The request form.
6.3  Transfusion History
7.0  Blood samples.
7.1    Maternal sample and history
7.2    Sample from baby less than 4 months of age.
7.3    Sample from baby more than 4 months of age
8.0    RED CELL TRANSFUSION
8.1    Risk
8.2    Small volume transfusion “top ups” (10-20ml/kg)
8.3    Exchange transfusion.
8.4    Intrauterine transfusions
9.0    PLATELET TRANSFUSIONS
9.1             Checking, Administration, Monitoring & Documentation
9.2    Platelet Concentrates
9.3    Indications
9.4    Dosage
9.5     Adverse Reactions
10.0   FRESH FROZEN PLASMA (MBFFP) TRANSFUSIONS
10.1            Checking, Administration, Monitoring & Documentation
10.2   The product
10.3   Indication
10.4   Contra indication
10.5   Dosage
10.6   Adverse Reactions
11.0   CRYOPRECIPITATE TRANSFUSION
11.1            Checking, Administration, Monitoring & Documentation
11.2   Indications
                  11.3                 Contra-indication
11.4    Dosage
11.5   Storage
11.6    Adverse Reactions
12.0   ALBUMIN TRANSFUSION
12.1          Checking, Administration, Monitoring & Documentation
12.2   Dose
12.3   Adverse Reactions
13.0   GRANULOCYTE TRANSFUSION (Buffy Coat Concentrate)
13.1   Introduction
13.2   Risk
13.3   Indication
13.4   Dose
13.5   Contra indication
13.6            Adverse Reactions
14.0   Administration of Blood Products
15.0   Co – Infusion of Products
16.0   Observation of The Patient
17.0   Risk and Adverse Reaction
17.1   Additional Risks and Reactions
18.0   Transfusion Reaction
18.1   Management of Transfusion Reaction.
19.0   Patients Requiring Special Considerations.
19.1   Necrotizing Enterocolitis.
19.2   Haemoglobinopathies
19.3   Haemopoietic Sct, Aplastic Anaemia And Malignancies
19.4   Congenital Coagulopathy
19.5   Patient Who Refuse Blood
20.0   Information Leaflets.
21.0   References

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Hospital Transfusion Committee                             Page 196 of 225
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Ref: PCD 032(v1)                                                    Status : Operational

                                Blood Transfusion Policy
                                      Appendix 25
                           Neonatal Blood Transfusion Policy
                          Including Use of Paediatric Products

1.0 Introduction
Neonates in S.C.B.U. are one of the most transfused patient groups. Because it is hoped
these patients will have a normal life expectancy it is important to avoid (multiple) donor
exposure.

2.0 Aims and Objectives
To ensure the safe and appropriate use of blood products for neonates in there first year of
life.

3.0 Scope
The policy relates to all staff involved in the transfusion process
The rules and policies relating to transfusion will apply in the Neonatal setting. However
there are specific considerations which will be covered in this document. It should however
be read in conjunction with the other transfusion related policies.

4.0 Paediatric blood products.
All blood products, except granulocytes are leucodepleted. The laboratory staff, in
conjunction with the National Blood Service will ensure the blood products supplied will meet
the criteria required for paediatric use with regard to Age of blood, Leucodepletion, Blood
Group, Antibody status, CMV status, Irradiation etc,

5.0 Consent
Parental consent to the transfusion will be required for transfusion of all blood products and
must be recorded in the medical notes. Exception to this, e.g. a lifesaving emergency, must
be documented.

6.0 Prescribing
The type of blood product, volume and rate of transfusion must be written on a prescription
chart by the clinician. This must be signed.

6.1 Reason for Transfusion
For medico-legal reasons, the clinician will record in the patient’s note the basis for the
decision to transfuse.

6.2 The request form.
It is extremely important to give all the relevant clinical details and specific blood
requirements so the blood bank can select the correct product.

Useful information includes the gestation and birth weight of the infant as well as the
maternal name, hospital number and d.o.b.

6.3 Transfusion History
Remember, if the patient has been transferred from another hospital it is extremely important
to include any transfusion history on the request form. On many occasions D.V.H. patients
have been inaccurately grouped as O Rh D Negative because their blood currently contains
red blood cells transfused at another site.




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Also, Importantly, a child who has a history of intrauterine/exchange transfusion will require
irradiated blood products in the first year.

7.0 Blood samples.
You will be required to follow the trust protocol for labelling transfusion samples as
inadequately / incorrectly labelled sample will be rejected.

Take extra care, you cannot ask a baby its name, so ensure you double check the
information. More errors occur in SCBU than with any other patient group. Common errors
include use of maternal name/number and misidentifying twins.

7.1 Maternal sample and history
Neonates do not produce their own blood group antibodies in the first few month of life. Their
blood may however contain circulating maternal antibody.

If the laboratory does not have a recent result of the maternal antibody screen they will ask
for a (one off) maternal sample for group and screen.

If the mother is known to have antibodies, a maternal sample will be required for cross-
matching blood intended for her baby. If you have any queries, please contact the blood
bank on ext 8501.

7.2 Sample from baby less than 4 months of age.
Before the blood bank will issue blood products they will need to establish the patient’s blood
group. For this they will require 0.3ml EDTA blood.

7.3 Sample from baby more than 4 months of age
A sample will be required by the blood bank to perform a full crossmatch.
Minimum volume 0.5 ml EDTA

8.0 RED CELL TRANSFUSION
Generally, Paediatric blood is supplied as blood group O Rh D negative.

This will not be so if the mother irregular antibodies which react with this group. e.g. Anti Rh
anti c, or those antibodies not related to the Rh system such as Fya etc. If mother has an
antibody specially selected blood will be sort form the National Blood Service.

8.1 Risk
Please see the Trust Transfusion Policy. The same risks apply to neonates as to adults,
however special consideration must be made with regard to circulatory overload. The exact
volume to be transfused must be clearly documented.

Routine use of frusemide during elected transfusion is not recommended. Be advised
by Paediatrician as to when and if diuretic cover is required.

IClinicians should give clear instruction on the prescription chart.

Medics MUST weigh the risks of transfusion against the clinical situation.

8.2 Small volume transfusion “top ups” (10-20ml/kg)
Blood for this will be supplied as paedipacks, - where one blood donation is divided
into 8 aliquots. This enables repeated transfusions to be given from one donation.



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It is important when ordering the first unit to indicate to blood bank staff whether
further units may be required so they can reserve the stock.

   8.2.1 Common Causes of Neonatal Anaemia in neonates
   •   Preterm delivery before establishment of normal red cell and iron stores in last
       trimester.
   •   Phlebotomy losses.
   •   Expansion of blood volume with growth.
   •   Physiological cessation of red cell synthesis in the first 6 weeks after birth.

Although these factors combine to result in the ‘normal’ fall in haemoglobin
concentration in the first 6-9 weeks after birth, this is accompanied by improved
oxygen unloading capacity as 2,3DPG levels rise, so that tissue oxygen delivery may
improve despite reduced oxygen carrying capacity. Thus the possible benefits of
transfusion need to be balanced against the known (and unknown) risks for each
individual baby.

   8.2.2 Indications for Transfusion
    • Anaemia
    • Babies with cardio-respiratory disease.
    • Shock due to blood loss.
    • Prematurity
In infants below 1000g maintain a blood log. Optimise circulating volume following
delivery, monitor haematocrit and haemoglobin and transfuse whenever the blood
log is negative by 10% of the circulating volume (10% of 80mls /kg)

  8.2.3 Guideline of suggested thresholds for children under 4 months of age

   •   Anaemia in 1st 24 hours                  Hb 12g/dl Hct 0.36
   •   Cumulative blood loss in 1 week ,
       of neonate requiring intensive care            10% blood volume.
   •   Neonate receiving intensive care         Hb 12g/dl
   •   Acute blood loss                         10%
   •   Chronic oxygen dependency                      Hb 11g/dl
   •   Late anaemia – stable patient            Hb 7g/dl

    Contra-indications
    • Stable growing babies > 6 weeks old.
Transfuse only if haematocrit < 0.25 and baby symptomatic. Transfusion at this age
will inhibit the normal onset of erythropoiesis and should be discussed with the
Consultant. Oral iron supplements should be started at 6 weeks of age.

8.2.4 Calculating volume required for transfusion.
Blood required is calculated as:

Desired Hb (g/dl) minus the actual Hb (g/dl) x weight (kg) x 38.3




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Hospital Transfusion Committee                             Page 199 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational
8.3 Exchange transfusion.
This is a specialist procedure which should be undertaken by experienced staff to
manage severe anaemia and/or severe hyperbilirubinaemia. Darent Valley patients
are usually treated at Lewisham Hospital. Please remember that if the patient returns
to Tambootie the transfusion history should be relayed to the blood bank staff when
requesting blood products.

8.4 Intrauterine transfusions
This procedure is not performed at D.V.H. However please remember the patient may have
been transfused at a specialist centre before returning to Tambootie.
This information must be relayed to blood bank staff when requesting blood products.

8.5 Adverse Events
See Appendix 24 Adverse Reactions and Events

9.0 PLATELET TRANSFUSIONS
Generally the policy in relation to neonates is more liberal than with adults, in as much as the
consequences of catastrophic bleeding are arguably greater. Advice should be sought from
the Consultant Haematologist.

9.1 Checking, Administration, Monitoring & Documentation
As for all blood products.

9.2 Platelet Concentrates
Platelets should be ABO and Rh D identical with the recipient. If this is not possible
the NBS will supply units lacking high titre ABO antibodies.

Single random platelet concentrates are made from individual units of whole blood.

The component should contain >200 × 109 platelets in approximately 60 ml of
plasma, at a concentration not exceeding 3.9 × 1012/litre

Platelets are not a stock item as they have a Shelf Life of 5 days only.

9.3 Indications

    9.3.1 Neonatal alloimmune thrombocytopenia (NAIT)
When newborn present with unexpected low platelet count one must consider the possibility
of N.A.I.T. In this condition the patient’s platelets are destroyed/impaired by maternal platelet
antibodies which have crossed the placenta.

The infant is at risk of haemorrhage. Transfusion will be required if Platelet count is less
than 30 x 109/l

Maternal and Paternal samples must be sent for testing ASAP. Human Platelet Antigen
(HPA) matched platelets may be required in addition to i.v. immunoglobulin.

N.B. HPA matched platelets are issued from Cambridge NBS, so take a little longer to arrive
at Darent Valley.

  9.3.2 Thrombocytopenia (Platelets reduced).
Consider transfusion if:-
  • Preterm or term neonate, with bleeding                    count 50 x 109/l .
  • Sick preterm or term infant, not bleeding                 count 30 x 109/l .
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Hospital Transfusion Committee                             Page 200 of 225
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   •   Stable preterm or term infant, not bleeding            count 20 x 109/l .
   •   If there is petechaie, bruising, bleeding or co-existent coagulopathy / DIC or
       concurrent use of anticoagulants count <50 x 109/l

  9.3.3 Thrombasthenia (Platelets not functioning)
Seek advice from the Consultant Haematologist.

9.4 Dosage
Usually 10-20 ml/kg, given over 30-60 mins.

9.5 Adverse Reactions
See Appendix 24 Adverse Reactions and Events

10.0 FRESH FROZEN PLASMA (MBFFP) TRANSFUSIONS

10.1 Checking, Administration, Monitoring & Documentation
As for all blood products.

10.2 The product
Because of the risk of vCJD, as of 2004, fresh frozen plasma (FFP) for babies and children
born after 31st Dec 1995 is sourced from the USA. To further reduce the risk of viral
transmission, F.F.P .is treated with a methylene blue process (MBFFP).

MBFFP will be issued as ABO compatible, group specific. Be aware that because we hold
small stocks at D.V.H. Neonatal MBFFP is often supplied as group AB.

Virally inactivated FFP should be used for those patients with inherited coagulation
deficiencies where no factor concentrate is available.

Please be aware that this extra treatment renders the product with lower coagulation factors
than untreated plasma.

A small stock of plasma is available from the blood bank. Neonatal packs take 15 to 20
minutes to thaw.

10.3 Indication
Documented coagulopathy where fractionated products are not available.
Disseminated Intravascular Coagulation (DIC) with Clinical bleeding.
High INR associated with bleeding. (Remember normal INR in preterm is higher than in
adults).
Severe vitamin K deficiency with bleeding (must give concurrent IV vitamin K)
Severe liver disease
Bleeding due to sepsis
Haemolytic-uremic syndrome (HUS) / Congenital thrombotic thrombocytopenia (TTP)
syndromes.

10.4 Contra indication
   • Simple volume replacement
   • Prevent periventrical hemorrhage
   • Treat sepsis by improving immune function -N.B. this may increase mortality.

10.5 Dosage
10 – 20ml / kg over 30-60 minutes


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Hospital Transfusion Committee                             Page 201 of 225
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Ref: PCD 032(v1)                                                   Status : Operational
10.6 Adverse Reactions

See Appendix 24 (PCD 032-A24) Adverse Reactions and Events

11.0 CRYOPRECIPITATE TRANSFUSION
11.1 Checking, Administration, Monitoring & Documentation
As for blood and blood products.

               Heat-treated fibrinogen products are currently unlicensed and not available in
               paediatric doses.

               Cryoprecipitate is a fibrinogen rich product prepared from plasma. Currently US
               sourced, methylene blue treated, product is not available. The National Blood
               Service hope to have small stock available by the end of 2005.

11.2 Indications
   • Hypofibrinogenaemia where the fibrinogen level is < 1g/l

   •   Treatment of patients with fibrin stabilising factor (FactorXIIIdeficiency).

               11.3 Contra-indication
               Cryoprecipitate is no longer the treatment of choice for haemophilia. One should use
               Recombinant Factor VIII (synthetic derived product).

11.4 Dosage
               5 mls/kg weight

11.5 Storage
               Frozen cryoprecipitate is stable for one year at -30oC.
               Once thawed it should be used within 6 hours
               Do not refrigerate after thawing as otherwise insoluble cryoprecipitate may reform.

11.6 Adverse Reactions
             See Appendix 24

12.0 ALBUMIN TRANSFUSION
In adults albumin transfusion may be associated with increased mortality. There is no
information for paediatric practice, as the analysis has not been done.

At D.V.H. this product is obtained through Pharmacy.
It should be available in 50ml size for neonatal use. Since the product is heat treated it is
free of risk of transmission of known viral diseases. There is a theoretical risk of vCJD.

12.1 Checking, Administration, Monitoring & Documentation
As for blood and blood products.

12.2 Dose
10-20mls/kg.

12.3 Adverse Reactions
             See Appendix 24 (PCD 032-A24)




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Hospital Transfusion Committee                             Page 202 of 225
Transfusion Policy                                                    November 2005
Ref: PCD 032(v1)                                                  Status : Operational

13.0 GRANULOCYTE TRANSFUSION (Buffy Coat Concentrate)

13.1 Introduction
This product is usually used in specialist centres. It is a concentrate of the white cells and
platelets obtained from a freshly centrifuged unit of whole blood. Buffy coats must be used
within 12 hours of preparation to get maximal effect of the leucocytes.

13.2 Risk
White cell transfusion can be associated with transfusion reactions and should only
be prescribed after discussion with the Consultant Haematologist since these
patients may respond to G-CSF.

13.3 Indication
Buffy coat preparations are sometimes used in the treatment of overwhelming gram negative
septicaemia in young neonates where other therapies have failed.

   •   Septic neutropenic baby with neutrophils 0.5 or less for 24 hours.
   •   Septic baby with poorly functioning neutrophils, e.g. chronic Granulomatous
       Disease.
   •   Neutropenic children with severe bacterial or fungal infection, who are
       clinically deteriorating and unlikely to recover in a week despite maximal
       supportive care, including cytokines.

The product will be blood group compatible as it is heavily contaminated with red
blood cells and will be crossmatched using the same rules as for red blood cells.

13.4 Dose
1-2 x 109 granulocytes/kg. A single does will be required at least twice a day.

13.5 Contra indication
This product should not be used prophylactically.

13.6 Adverse Reactions
             See Appendix 24 (PCD 032-A24)

14.0 ADMINISTRATION OF BLOOD PRODUCTS
For the process of transfusing, please see protocol, Appendix A at the end of the document.

15.0 CO – INFUSION OF PRODUCTS
Co infusion with blood products is not recommended.

16.0 OBSERVATION OF THE PATIENT
For the process of observing the patient, please see protocol, Appendix A at the end of the
document

Maintain strict fluid balance chart, including urine output.

17.0 RISK AND ADVERSE REACTION
See Appendix 24 (PCD 032-A24)




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Hospital Transfusion Committee                             Page 203 of 225
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Ref: PCD 032(v1)                                               Status : Operational


17.1 Additional risks and reactions

       17.1.1 Recognising signs and symptoms
Unlike adults, these patients may not be able to communicate or show signs of discomfort. It
important to monitor them closely and act on any adverse observations.

       17.1.2 Volume overload

Because of their small blood volume, it is easy to risk a neonate to Hyperviscosity with red
cells, Hyperosmotic pressure with albumin, Hypervolaemia with all blood products.

       17.1.3 Haemolysis

Haemolysis, the disintegration of red cells can occur for many reasons. This is of more
significance in the paediatric setting. Beware of:
    • Infusing blood rapidly through small gauge needles
    • Infusing through a 0.22 micron filter
    • Overheating blood
    • Storage at incorrect temperature
    • Mixing blood with other drugs
    • Mixing dextrose with blood in the giving set.

18.0 TRANSFUSION REACTION

Type of reaction             Signs and Symptoms

Febrile                      Pyrexia, rigors
Circulatory overload         Increase in blood pressure, heart rate and respiration
Allergic                     Urticaria, facial oedema, dyspnoea, hypertension
Haemolytic                   Collapse with hypertension.
                             Shock, pyrexia, rigors, haemoglobinurea, haemoglobinaemia.
                             Oliguria, later uraemia.
Infected blood               Pyrexia, profound collapse and shock, pallor, dyspnoea, low
                             blood pressure, rapid pulse.

18.1 Management of Transfusion Reaction.
   1. STOP THE TRANSFUSION
   2. Contact the doctor and blood bank immediately
   3. Record and document vital signs
   4. Maintain patency of cannula using a new giving set and 0.9% sodium chloride
   5. Check the blood label and recipient ID information is correct
   6. Send blood product & giving set back to blood bank


   7. Take blood samples (from a different vein) for group & screen, fbc and U&E.
   8. If sepsis is suspected send blood culture sample.
   9. If respiratory distress test blood gases.
   10. Send urine to check for haemoglobinuria
   11. Send coagulation screen if bleeding.
   12. Inform parents.




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Hospital Transfusion Committee                             Page 204 of 225
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19.0 PATIENTS REQUIRING SPECIAL CONCIDERATIONS.

       19.1 NECROTIZING ENTEROCOLITIS.
These patients may be infected with neurominidase producing organisms. These enzymes
may “strip” the surface of the patients’ red blood cells, exposing the T-crypto antigen. This is
commonly called T-activation and is confirmed by testing against a lectin panel. (Speak to
blood bank ext 8501)

The problem is that all adults (e.g. blood donors) have anti T antibodies.

Because of this red cells in SAG-M are selected for transfusion as it has a relatively low
amount of plasma in the product.

Plasma rich products, F.F.P. Cryoprecipitate and platelets should only be administered when
clearly indicated. Assess to “low titre anti T” products is very limited.

        19.2 HAEMOGLOBINOPATHIES
19.2.1 General consideration.
For patients who are destined for multiple transfusions / stem cell transplantation the
following is recommended.

   •   They be vaccinated against hepatitis B
   •   CMV Negative components are selected.
   •   The have an extended blood group performed for patient history. Rh & K in
       thalassaemia, Rh K, Fy. Jk, MNS (U Iif S-s-) in sickle patients.
   •    Red cells for transfusion should be selected for full Rh and K type to prevent
       alloimmunisation.

19.2.3 Thalassaemia major
Most transfusion start when the Hb falls below 6g/dl

Thalassaemia International Federation Guidelines include the recommendations:

    • Maintain average Hb of 12g/dl
    • Maintain pre transfusion Hb 9-10g/dl
Risk
There is an additional risk of iron overload. Iron chelation therapy should be considered after
10 transfusions and once the serum ferritin level is >1000μg/l (preferably when the child is >
2yrs)

19.2.4 Sickle cell disease.
Transfusions are not given routinely, but for specific indications:

   •   Splenic or hepatic sequestration
   •   Aplastic crisis

The aim is to raise the patient Hb to their normal steady state. Do not raise the Hb acutely to
>10g/dl.

        Exchange transfusion in SCD
This is considered when the aim is to reduce the amount of sickling and increase oxygen
carriage without increasing blood viscosity. e.g.


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   •   Acute chest syndrome
   •   Stroke
   •   Priaprism

  Hypertransfusion in SCD
Where the aim is to maintain an Hb of 10-14.5gm/dl with an Hb S > 25%

   •   To prevent reoccurrence of stroke
   •   To prevent stroke in high risk patients
   •   To prevent / delay deterioration in end organ failure

   Surgery and SCD
Transfusion seems to be standard practice, although this is not evidence based.

   •   Minor / straightforward procedures can be safely undertaken without transfusion in
       most cases.
   •   Pre operative top up transfusion aiming for Hb 8-10g/dl for major surgery or eye
       surgery. This is safer than exchange transfusion.
   •   Exchange transfuse when the aim is to reduce the HbS to < 20%

   19.3 HAEMOPOIETIC SCT, APLASTIC ANAEMIA AND MALIGNANCIES
Decision to transfuse will depend on many factors.
Generally red cell transfusions are reserved for symptomatic patients with an Hb <7.0g/dl

       19.4 CONGENITAL COAGULOPATHY
Insure adequate samples are taken for full investigation prior to transfusion of any product.

If treatment cannot wait until results are available , use virally inactivated plasma at a dose of
20ml /kg .

FFP is not optimal therapy for the more common and severe coagulopathies. These should
be treated with specific factors.

19.5 PATIENT WHO REFUSE BLOOD
See section of the Trust Transfusion Policy.

20.0 INFORMATION LEAFLETS.
A variety of information leaflets supplied by the NBS are available on the wards.
For further information contact the transfusion practitioner on ext 4666 or blood bank on ext
8501 or look at the NBS website www.blood.co.uk/hospitals

21.0 REFERENCES
Transfusion guidelines for neonates and older children.        BJH,124, 433-453




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Hospital Transfusion Committee                             Page 206 of 225
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Ref: PCD 032(v1)                                                   Status : Operational
Appendix A

       Administration of Blood and Blood Products on Tambootie Ward
       -         In brief:- See Adagio for full policy.

   1. Policy Statement
   Tambootie ward is committed to ensuring safe transfusion practices for all patients.

   2. Introduction

       2.1 The purpose of the policy
       This policy is to ensure the safe administration of blood and blood products to
       patients on Tambootie ward. The policies relating to transfusion generally hold true
       for all patients; however paediatric patients have particular needs around
       administration of blood products.

       2.2 Scope
       The policy is for those staff involved in the process of administering blood products.
       The policy will relate directly to administration. It this therefore important it be read in
       conjunction with other Trust transfusion policies:
           • Trust Policy 6 – Removal of blood from Blood Bank (Feb 1999).
           • Trust Policy 8 – The use of Infusion Pump (Jan1999).
           • Trust Transfusion Policy – Currently in draft.

       2.3 Policy Holders.
       The policy will be held by the Senior Sisters of Tambootie ward. It will be reviewed by
       them with input form key personnel.

   3. Equipment required for the administration of blood products.

       3.1 List of equipment required.
       The following equipment will be required for administration of blood.
           • a pair of non-sterile gloves,
           • alcohol wipe
           • 50mls syringe,
           • extension set for the syringe pump (IVAC G30402M),
           • 50mls syringe pump, and a infusion Alaris MFX2279 set with filter (screen
               filter 170-200u)(1).
           • cardiac and respiratory monitor
           • transfusion chart

       3.2 Giving sets and filters.

       For red cells, fresh frozen plasma and cryoprecipitate transfusion use a sterile blood
       administration set with a screen filter (170-200u).
       The giving set must be changed at least 12 hourly. A new giving set should be used
       if another fluid is to be infused following the blood transfusion.

       For platelets transfusion, use the administration set provided by the Trust Blood Bank
       or screen filter Alaris MFX2279.

   4. Pre transfusion checks
      Before collecting the blood, check the following:



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       4.1 Consent
       Unless the situation is a lifesaving emergency, doctors will have gained parental
       consent for the transfusion. Ensure this has been written in the notes.

       4.2 Prescription
       The medic will have written on the prescription chart the type of blood product, the
       volume require, date and duration of infusion. This must be signed by them.

       In addition, as a medico-legal requirement, the notes must clearly state the reason
       for transfusion.

       4.3 Availability of blood product.
       Check on TPath or with the laboratory (ext 8502) that the blood is available for
       collection.

       4.4 Check Patient
       Ensure i.v. access.

       Ensure pre transfusion observations have been checked and recorded.

       4.5 Collect blood.
       Blood must be collected by staff trained in this process. Generally this is done by
       porters.
       See blood collection policy.

   5. Administration.
      The following will take place at the cot-side.

       5.1 Checking the unit.

       Two registered nurses, one of whom has extended her role to the administration of
       I.V. drugs, will be responsible for checking information pertaining to the patient and
       the blood product.

       Check the blood product for the following;-
          • That there are no signs of leakage or contamination.
          • The expiry date.
          • That the blood product identification number on the blood unit matches that
              on the label and compatibility form.
       Check the patients demographics ensuring that, baby’s name, date of birth and
       hospital number are same on the:-
          • Wristband
          • notes / prescription chart
          • blood bag label
          • compatibility sheet

       If there are any discrepancies, do not commence the transfusion. Inform the blood
       bank and the doctor.

       Both nurses will sign, and record start time on the prescription chart and compatibility
       form.

       5.2 Starting the transfusion

            •   Wash your hands and wear the non sterile gloves during the whole
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                Procedure..
            •   Connect the blood bag, the 50mls syringe and the syringe extension
                set (IVAC G30402M) to the Alaris MFX227950 set. Set up the
                transfusion unit as illustrated in the Diagram A.
            •   Insert the 50mls syringe into the syringe pump (leaving the blood bag
                attached to the set) and set the volume and the rate to be infused.
                The infusion of the pack will not exceed 4 hours.
            •   Clean the cannula port hole with a mediswab then flush the cannula
                with 0.9% saline.
            •   Attach the syringe extension set to the cannula and commence the
                transfusion.
            •   If the baby is less than 7 days old, perform PKU test before the start of
                the transfusion.
            •   Transfusion should commence within 30 minutes of a pack of red cells being
                removed from the blood bank. If the transfusion is to be abandoned the unit
                must be returned to the blood bank within 30 minutes or it will be discarded.
           •    Record the start time.

       5.3 Administering diuretic
       A registered nurse with the extended role of administration I.V. drugs will give the
       prescribed intravenous diuretic. Normally this is administered half way through the
       transfusion.

       2.5 Monitoring
       Record baseline observations:
           • Temperature
           • Apex
           • Pulse
           • respiratory rates
           • blood pressure
           • baby’s colour
       The baby’s heart and respiratory rates should be monitored continuously during the
       Transfusion.

       Repeat and record observations at 15 and 30 minutes after the commencement of
       the transfusion. The nurse should stay with the baby during this time.

       If no adverse reaction occurs, observations of the cannula site, volume infused,
       temperature, apex and respiratory rates can be recorded hourly until transfusion is
       finished.

       If any sign of reaction is noted e.g. raised temperature and/or heart rate, drop in BP
       and oliguria the transfusion should be stopped immediately and medical staff
       informed.

       2.6 On completion.
       Record the temperature, heart and respiratory rates, colour and blood pressure.
       Complete the documentation in the nursing care plan, prescription and infusion
       charts.

       I.V. cannula can either be removed or flushed with saline depending on each baby’s
       condition.




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Ref: PCD 032(v1)                                            Status : Operational
       2.7 Disposal
       In accordance with Trust policy, the empty pack will be sealed to prevent leakage
       and returned to the blood bank.

   6. References for appendix A
   1. Boulton F (2004) Transfusion Guidelines for Neonates and Older
      Children British Journal of Haematology 124 433-453

   2. McCormack K (1998) Neonatal Blood Transfusion: A Case for Guidelines Journal
      of Neonatal Nursing 4 (5) 12-17

   3. Williamson L M, Lowe S, Love E, Cohen H et (1999) Summary of Annual Report
      Serious Hazards of Transfusion

   4. WWW.transfusionguidelines.org.uk 31/07/2004 Administering Blood Components and
      Blood Products

   5. Bruce M, Roe M (1997) Routine Observations of Babies during Top Up Blood
      Transfusions: A Ritualistic Practice? Journal of Neonatal Nursing 3 (3) 19-22

   6. Place B (1998) The Transfusion of Blood and Its Products Nursing Times 94 (34)
      48-50

   7. www. Transfusionguidelines.org.uk    31/07/2004    Blood administration sets and
      equipment




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Ref: PCD 032(v1)                                       Status : Operational


Diagram A: Illustrating the closed blood giving circuit




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          Transfusion Policy
             Appendix 26
     Protocol for Performing Acute
  Normovolaemic Haemodilution (ANH)

                     Date: November 2005

                     Ref : PCD 032 – A26

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032-A26
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record




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Hospital Transfusion Committee                             Page 212 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




                               Transfusion Policy
                                  Appendix 26
       Protocol for Performing Acute Normovolaemic Haemodilution (ANH)

Content

1.0    Introduction
2.0    Aim and Objectives.
3.0    Scope
4.0    Roles and Responsibilities.
5.0    Benefits
4.0    Patient selection
5.0    Contra indication
6.0    Consent
7.0    Procedure
7.1    Infection Control
7.2    Rate of withdrawal
7.3    Prevention of Clots
7.4    Volume withdrawn.
7.5    Volume replacement
7.6      Labelling the pack:
7.7      Documentation
7.8    Storage of withdrawn blood
7.9    Administration.
8.0    Disposal of unused units.
10.0   Health & Safety
11.0   References




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                               Transfusion Policy
                                  Appendix 26
       Protocol for Performing Acute Normovolaemic Haemodilution (ANH)

1.0 Introduction
ANH entails the withdrawal of a predetermined amount of blood from a patient in the
anaesthetic room, either immediately before or shortly after induction of anaesthesia, and
simultaneous volume replacement with crystalloid and/or colloid solution to maintain
normovolaemia. The blood removed is reinfused as indicated by either intraoperative blood
loss or at the conclusion of surgery.

2.0 Aim and Objectives.
Reduce the reliance on, and risks associated with transfusing allogeneic blood.

3.0 Scope
This will primary concern the surgical team as the blood will not leave theatre.

4.0 Roles and Responsibilities.
The decision to recommend ANH for an individual patient should lie with the anaesthetist
and surgeon. The responsibility for the procedure itself normally lies with the anaesthetist.

5.0 Benefits
ANH is simple, inexpensive and available to patients undergoing surgery at short notice.
Benefits may include:
    • Lower blood viscosity may improve tissue perfusion and oxygenation.
    • Reduced red cell loss with haemorrhage.
    • Provides fresh whole blood with coagulation factors and functional platelets.
    • Reduced need for allogeneic blood, thereby avoiding disease transmission and
       immune mediated reactions.

Patients undergoing ANH need not be screened routinely for viral markers.

4.0 Patient selection
Patient should have near normal oxygen transport capacity, should ideally be free from
cardiovascular, respiratory and cerebrovascular diseases.

BCSH guidelines suggest that patients have a haemoglobin level of >11 g/dl, but this should
not be used in isolation to exclude otherwise fit candidates.

ANH should be considered when the likely surgical blood loss exceeds 20% of the patient’s
blood volume, or in practical terms, where the Blood Bank would normally crossmatch at
least two units to cover the procedure.

ANH may be considered for any elective surgical procedure where there is no sepsis
present.

5.0 Contra-indication
The technique is contraindicated when compensatory mechanism, an increase in cardiac
output, is neither possible nor desirable. Conditions include:

   •   Haemoglobin < 11 g.dl.
   •   Ischaemic heart disease, critical stenotic heart valve disease, symptomatic aortic
       stenosis.
   •   Hypertension
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   •   On beta-blockers or calcium channel blockers.
   •   Restrictive or obstructive lung disease.
   •   Impaired renal function and inability to handle large fluid volume.
   •   Coagulation disorders.
   •   Potential or active bacterial infection.
   •   Hypovolaemia.

6.0 Consent
The patient should have the procedure explained to them, including its associated merits,
risks and the possibility of homologous transfusion being required.

Be aware that ANH may be contrary to the patients’ religious belief.

7.0 Procedure
             7.1      Infection Control

Blood should be withdrawn through an arterial or venous catheter under strict aseptic
technique to provide maximum assurance of a sterile product.

As no viral marker testing is performed on the patient prior to donation, the blood collected
by ANH is by definition ‘Danger of Infection’, and universal precautions to protect staff from
the risks of virus transmission must always be observed.

              7.2      Rate of withdrawal
The rate should be stat. or as flow allows. One unit should not take more than 6 minutes or
clots may form in the line.

                7.3    Prevention of Clots
Appropriate blood collection packs must be used to ensure a standard anticoagulant to blood
ratio. Stocks are provided by the blood bank.

It is important that these packs are NOT OVERFILLED or there will be activation of the
coagulation factors and even clot formation. Gently mix the pack when filled.

                7.4    Volume withdrawn.
The amount of blood that can be withdrawn depends on many factors. It is primarily limited
by a sufficient oxygen supply to the tissues, particularly to the heart. The age, medical
fitness, preoperative Haematocrit (Hct), intended post-haemodilution Hct and the kind of
surgery must be considered.

The safety of ANH depends on the maintenance of normovolaemia. In all patients, care
must be taken to match the continuous replacement of fluid with the volume of blood
removed. In older patients and where cardiac disease may be suspected, additional care is
necessary.

The risk of haemodilution (i.e. of an excessively low intra-operative haematocrit) can be
minimised by limiting the amount of blood removed (target haematocrit 25-30%).

The appropriate volume of blood to be removed (in litres) to achieve the desired haematocrit
can be calculated using the following formula;

                      Volume withdrawn = EBV x (Hct0 - Hct1)/Hctav
       EBV =          estimated blood volume
       Hct0 =         Hct before haemodilution

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Hospital Transfusion Committee                             Page 215 of 225
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Ref: PCD 032(v1)                                                 Status : Operational
       Hct1 =          desired Hct after haemodilution
       Hctav =         average of the Hct before and after Haemodilution


Example;       Assuming EBV = 70ml/Kg, start Hct = 0.400, target Hct = 0.300

                     Body Weight              EBV           Volume Withdrawn
                       (Kg)                   (litres)           (Litres)

                       50                     3.5                   1.0
                       60                     4.2                   1.2
                       70                     4.9                   1.4
                       80                     5.6                   1.6
                       90                     6.3                   1.8
                       100                    7.0                   2.0


Once the donation is complete, the bleed line must be sealed to leave two clips between the
bag and the cut end of the tubing.

         7.5                       Volume replacement
It is crucial to maintain normovolaemia throughout the procedure. Crystalloid and/or colloid
should be given simultaneously through a separate lumen or cannula as blood is withdrawn.

The amount of colloid administered should mirror what has been taken of then increased as
is indicated from clinical indications.

      7.6                           Labelling the pack:
The pack will be labelled “for autologous use only”

Although the procedure will be started and completed in theatre the blood pack must be
labelled during the donation process, with the following details
                      -       Surname
                      -       First Name(s)
                      -       Hospital Number
                      -       Date of Birth
                      -       Date and Time of Collection
                      -       Name of Medical Officer performing the procedure.

       7.7 Documentation
The program should be supervised by a nominated staff whose responsibility should include
compliance with procedure and their periodic review.

The anaesthetist will record:

   •   the volume of blood removed
   •   the amount and type of fluid infused
   •   the amount of blood returned.

These will be clearly documented in the patient’s case notes along with the patients vital
signs.


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Hospital Transfusion Committee                             Page 216 of 225
Transfusion Policy                                                                      November 2005
Ref: PCD 032(v1)                                                                    Status : Operational
       7.8 Storage of withdrawn blood
Blood collected by ANH must remain with the patient in theatre.

To preserve platelet function keep the blood at room temperature. Do not put in a blood bank
fridge. The blood must be completely re-infused within 6 hours.

If it anticipated that more than 6 hours will elapse before the transfusion will take
place, the blood should be refrigerated.

An insulated blood storage container with ice insert may be obtained from the blood bank
laboratory, and the blood safely stored in this for four hours. The time of placing the blood in
the container must be clearly documented on the label on the lid.

        7.9 Administration.
Pre-transfusion checks of identity are mandatory, as defined in the Transfusion Policy, and
involve confirmation of the patient’s;

Surname, First Name, Hospital Number and Date of Birth.

Transfuse via a standard giving set, incorporating a 170 - 200µ filter.

The number of ANH units transfused must be recorded in the patient’s case notes to serve
as a permanent record of the transfusion.

The occurrence and management of any adverse events associated with the transfusion of
ANH units must be documented in the patient’s case notes and reported to the Blood Bank
in exactly the same manner as for homologous units.

8.0 Disposal of unused units.
In general, all blood collected by ANH should be used in theatre.

Any unused units collected by ANH must be disposed of by theatre staff as ‘Hazardous
Waste’, according to current Trust policy.

The fate of any unused ANH units must be clearly recorded in the patient’s case notes.

10.0 Health & Safety
Care should be taken at all times to ensure the safety of staff and patients in theatre.

11.0 References and Reading
   1.   Gross JB. Estimating allowable blood loss: corrected for dilution. Anaesthesiology 1983; 58:277-280.

   2.   Stehling L and Zauder HL. Acute Normovolaemic Haemodilution. Transfusion 1991; 31:857-868.

   3.   Gillon J., Thomas MJG and Desmond MJ. Acute Normovolaemic Haemodilution Transfusion 1996;36:640-643.

   4.   BCSH Blood Transfusion Task Force. Guidelines for autologous transfusion II. Perioperative haemodilution and cell
        salvage. British Journal of Anaesthesia, June 1997, Vol 78, No6 p768 – 771




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                   Transfusion Policy
                      Appendix 27
                 Guidelines for the use of
                         Albumin



                     Date: November 2005

                     Ref : PCD 032 - A27

                     Vers : 1


      Policy Profile
      Policy Reference Number     PCD 032-A27
      Version                     1
      Status                      Operational
      Trust Lead                  L Delieu
      Implementation Date         November 2005
      Last Review Date
      Next Formal Review          July 2006
      Approval Record



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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 218 of 225
Transfusion Policy                                         November 2005
Ref: PCD 032(v1)                                       Status : Operational




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Dartford and Gravesham NHS Trust
Hospital Transfusion Committee                             Page 219 of 225
Transfusion Policy                                             November 2005
Ref: PCD 032(v1)                                           Status : Operational
                                 Transfusion Policy
                                    Appendix 27
              Guidelines for the use of Human Albumin Solution (HAS)

Contents

1.0 Introduction
2.0 Aims and Objectives
3.0 Scope
4.0 Consent
5.0 Risk
6.0 Prescribing / Ordering Albumin
7.0 Administration
8.0 Indications for Use
9.0 Indications - With No Benefits over Other Solutions.
10.0 Dosage
11.0 Contraindications
12.0 Patient Monitoring During Albumin Transfusion.
13.0 Transfusion Reaction
14.0 Other Effects of Albumin Transfusion
15.0 Pharmacological Properties
16.0 Pharmaceutical Particulars




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Hospital Transfusion Committee                             Page 220 of 225
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Ref: PCD 032(v1)                                                    Status : Operational
                                 Transfusion Policy
                                    Appendix 27
              Guidelines for the use of Human Albumin Solution (HAS)

1.0 Introduction
In the UK there are no formal guidelines for the use of crystalloid or colloid solutions. The
indications given below are taken from the current Handbook of Transfusion Medicine and
from The European Medicines Agency (E.M.A.), pre-authorisation Evaluation of Medicines
for Human Use 2005 – Core SPC for Human Albumin Solution.

1.1 Background
The E.M.A. has undertaken a review of albumin following a meta-analysis of clinical trials in
the critically ill, by the Cochrane Injuries Group, published in the BJM
(BMJ 317:235) This showed, critically ill patients treated with albumin, had a 7% increase in
mortality compared with patients who had received crystalloids or no treatment.

2.0 Aims and Objectives
To give guidance on albumin transfusion therapy, in order to improve transfusion practice
and to provide a benchmark for clinical audit.

3.0 Scope
This is aimed at all staff involved in the process of albumin transfusion.

4.0 Consent
This is a blood product. You may find that those patients who object to transfusion may or
may not accept albumin. For Jehovah’s Witnesses albumin solution is “a matter of
conscience”.

As for all blood products, consent should be obtained and record ed this in the notes
together with the reason for infusion.

5.0 Risk
Risk of virally transmitted infection are low, however there is still a theoretical risk of vCJD.
Main risks are from circulatory overload and hyperhydration.

6.0 Prescribing / Ordering Albumin Products
At Darent Valley Hospital Albumin is ordered though Pharmacy. Please refer to and abide by
pharmacy procedures. H.A.S. is available as 40 – 50 g/l albumin (4.5% solution) and 200 -
250 g/l albumin (20% solution).

7.0 Administration
Human albumin is administered I.V. and does not require a blood filter. The infusion rate
should be adjusted according to the individual circumstances.

8.0 Indication for Use
8.1 General indications
    • Restoration and maintenance of circulating blood volume where volume deficiency
       has been demonstrated, and use of a colloid is appropriate.
    • The choice of albumin rather than artificial colloid will depend on the clinical situation
       of the individual patient.

8.2 Use for Neonates on SCBU
• Hypotension
• Metabolic acidosis with poor peripheral perfusion.
• Resuscitation.
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8.3 Use for Adults
• Acute hypovolaemic shock in the elderly or those with pre-existing medical conditions in
    which the larger volume of crystalloid needed may be poorly tolerated. Alternative
    colloids such as HES may be as effective as albumin in minimizing pulmonary oedema.
• In combination with diuretics to initiate diuresis in nephrotic syndrome.
• To prevent hyponutreamia and renal dysfunction in patients undergoing paracenthesis
    (drainage of ascitic fluid).
• In severe burns after the first 24 hours - usage before this time has been demonstrated
    to cause a paradoxical increase in pulmonary oedema.
• In Acute Respiratory Distress Syndrome (ARDS) where the use of diuretics has caused
    a fall in effective plasma volume.- 20% albumin solution may be most effective here to
    initiate movement of water out of the interstitium into the plasma

8.4 Other Possible Indications
• Acute liver failure- to support plasma oncotic pressure and bind excessive billirubin,
    activated plasmin etc. Sometimes recommended in major paracetamol overdose.
• Renal dialysis if patients become hypotensive.

9.0 Indications - With No Demonstrable Benefits over Other Solutions.
• Intravascular volume expansion after trauma or major surgery.
• As part of total parenteral nutrition.
• In long term supplementation of albumin in nephrotic syndrome.

10.0 Dosage
The dose required depends on the size of the patient, the severity of trauma or illness and
on continuing fluid and protein losses.

Measures of adequacy of circulating volume and not plasma albumin levels should be used
to determine the dose required.

11.0 Contraindications
Albumin should be used with caution in conditions where hypervolaemia and its
consequences or haemodilution could represent a special risk for the patient. Examples of
such conditions are:
   • Decompensated cardiac insufficiency.
   • Hypertension.
   • Oesophageal varices.
   • Pulmonary oedema.
   • Haemorrhagic diathesis.
   • Severe anaemia.
   • Renal and post-renal anuria

Also beware of patients with hypersensitivity to albumin preparations or to any of the
excipients.

12.0 Patient Monitoring During Albumin Transfusion.
Haemodynamic performance should be monitored regularly for albumin transfusions; this
may include:
   • arterial blood pressure and pulse rate.
   • central venous pressure.
   • pulmonary artery wedge pressure.
   • urine output.
   • Electrolyte.

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   •   haematocrit/haemoglobin

13.0 Transfusion Reaction

13.1 Allergic or anaphylactic type reactions
Stop infusion immediately.

13.2 Shock
Stop infusion immediately. Standard medical treatment for shock should be implemented.

13.3 Circulatory overload and hyperhydration.
The colloid-osmotic effect of 20% human albumin is four times that of blood plasma.
Therefore care must be taken to assure adequate hydration of the patient. Patients should
be monitored carefully.

13.4 Electrolyte balance
20% HAS are relatively low in electrolytes compared to the 4.5% HAS

Monitor the patient and take appropriate steps to restore or maintain the electrolyte balance.

DO NOT dilute HAS with water as this may cause haemolysis in recipients.

13.4 Haemostasis
If large volumes of HAS are used, control of the patients coagulation and haematocrit are
necessary.

Care must be taken to ensure adequate substitution of other blood constituents (coagulation
factors, electrolytes, platelets and erythrocytes).

13.5 Hypervolaemia / Overdose
Take care with dosage and infusion rate.
Stop infusion immediately at the first clinical signs of cardiovascular overload (headache,
dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure
and pulmonary oedema.

Monitor the patient’s haemodynamic parameters

13.6 Mild reactions
Mild reactions such as flush, urticaria, fever, and nausea are rare. These reactions normally
disappear rapidly when the infusion rate is slowed down or the infusion is stopped.

14.0 Other Effects of Albumin Transfusion

14.1 Interactions with other medicinal products and other forms of interactions
No specific interactions of human albumin with other medicinal products are known.

14.2 Pregnancy and lactation
The safety of use in human pregnancy has not been established. However, clinical
experience with albumin suggests that no harmful effects on the course of pregnancy, or on
the foetus and the neonate are to be expected.

15.0 Pharmacological Properties
See Pharmacy Department

Under normal conditions, the average half-life of albumin is about 19 days.

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Hospital Transfusion Committee                             Page 223 of 225
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Ref: PCD 032(v1)                                                  Status : Operational
Elimination is predominantly intracellular.

In healthy subjects, less than 10 % of infused albumin leaves the intravascular compartment
during the first 2 hours following infusion. There is considerable individual variation in the
effect on plasma volume. In some patients the plasma volume can remain increased for
some hours. However, in critically ill patients, albumin can leak out of the vascular space in
substantial amounts at an unpredictable rate.

Human albumin must not be mixed with other medicinal products or blood products,

16.0 Storage
Store in the original container below < 25oC.
Keep in the outer carton to protect from the light.

16.3 Instructions for use and handling and disposal
The solution can be directly administered I.V. It can also be diluted in an isotonic solution
(e.g. 5 % glucose or 0.9 % sodium chloride).

Albumin solutions must not be diluted with water as this may cause haemolysis in recipients.

Do not use solutions which are cloudy or have deposits. This may indicate that the protein is
unstable or that the solution has become contaminated.

Once the container has been opened, the contents should be used immediately. Any unused
product should be disposed of in accordance with local requirements.


Terms:

Excipient:-    An inert substance used as a diluent or vehicle for a drug.




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