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TRANSFUSION OF BLOOD BLOOD COMPONENTS POLICY

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					TRANSFUSION
  OF BLOOD
COMPONENTS
   POLICY
Title                              Transfusion of Blood Components Policy

Author                             David Mold, Transfusion Practitioner

Associate authors                  Dr Clare Taylor, Transfusion Consultant

Target Audience                    All members of staff involved in the process of
                                   blood component transfusion
FreeNet                            http://freenet/trustpolicies.asp

Commissioning body                 Hospital Transfusion Committee

Stake holders consulted            Clinical practice group
                                   Hospital Transfusion Committee
                                   Directorates:
                                   Surgery, anaesthetics & critical care
                                   Clinical haematology, oncology & private
                                   practice
                                   Hepatology, nephrology & transplantation
                                   Medicine
                                   Neurosciences
                                   Women’s and children’s
                                   RNTNE, ENT, audiology & ophthalmology
Clinical Practice/ Advanced        Clinical Practice
Practice
Associated policies / guidelines   The Jehovah’s Witness undergoing surgery
                                   Major Haemorrhage Protocol
                                   Major Obstetric Haemorrhage Protocol
                                   Transfusion Training and Competency
                                   Assessment Policy
                                   Policy for the provision of O negative blood for
                                   emergency use at the Royal Free Hospital
Policy replacement                 Yes

Date of submission                 February 2008

Date of ratification               February 2008
Ratified by                        Clinical Audit and Effectiveness Committee
Review date                        February 2012




                                       2
CONTENTS
INTRODUCTION
     Definition
     Objective of Policy
     Professional Accountability
     Individual Staff Group Responsibility
     Responsibilities under the Blood Safety and Quality Regulations 2005

CONSENT
    Requirements
    Exceptions
    Withdrawal of Consent

TRANSFUSION
    Collection of Blood Samples for Pre transfusion Compatibility Testing
    Requesting of Blood and Blood Components
    Collection of blood and blood components from the blood bank and its
    delivery to the patient’s location
              Storage of blood and blood components
              Administration of blood and blood components
              Monitoring the transfusion of blood and blood components
              Management of transfusion reactions
              Incident reporting

APPENDICES

   1. - The Royal Free Hampstead NHS Trust Transfusion Training and
        Competency Assessment policy

   2. - The receipt of blood at the RNTNE

   3. - The receipt of blood at the satellite dialysis units

   4. - The policy for the provision of O negative blood for emergency
        use at the Royal Free Hospital

   5. - The transfer of blood components with patients between hospitals

   6. - The procedure for giving blood transfusions to neonates

   7. - Special blood product requirements

   8. - The Blood Transfusion laboratory site on FreeNet

   9. - Terms of reference for the Hospital Transfusion Committee

   10. Equality Impact Assessment



                                       3
Introduction

A blood transfusion is:
       a potentially hazardous procedure which should only be given when the
       clinical benefits to the patient outweigh the potential risks, the most important
       of these being acute haemolytic reactions and transfusion-transmitted
       infections. Stringent procedures must be followed to ensure that the correct
       blood is given and that any adverse reactions are dealt with promptly and
       efficiently.

The objective of this policy is:
       To inform hospital staff of the correct method of prescribing, ordering, storing,
       administering a blood or blood component transfusion and disposing of empty
       component bags and used giving sets. It is written incorporating guidance
       from the British Committee for Standards in Haematology. Guidelines for the
       administration of blood and blood components and the management of
       transfused patients. Transfusion Medicine 1999; 9, 227-239

Accountability
As registered professionals, individual members of staff are personally accountable
for their practice. This practice must be in accordance with the Hospital's policies and
procedures. No practitioner may adopt policies that differ from this document. Many
groups of staff are involved in one or more aspects of blood transfusion. Some
procedures are specific to one staff group but many can be carried out by more than
one. These guidelines set out to define the responsibilities of each staff group.
Nurses of differing grades and experience should only carry out those aspects with
which they are competent “To practise competently, you must possess the
knowledge, skills and abilities required for lawful, safe and effective practice without
direct supervision. You must acknowledge the limits of your professional competence
and only undertake practice and accept responsibilities for those activities in which
you are competent." paragraph 6.2 The NMC Code of professional conduct:
standards for conduct performance and ethics Nursing & Midwifery council. April
2007




                                           1
Staff Group Responsibilities

Medical staff are solely responsible for:
      • Prescribing blood, blood components and blood products. It is essential
          that the prescription sheet should contain the patient identification details
          (surname, first name, date of birth, the gender of the patient, patient
          hospital number) and the consultant and speciality details.
      • The prescription must specify:
                    the blood or blood component to be administered, including any
                    special requirements, e.g. gamma-irradiated, CMV-sero-negative
                    the quantity to be given
                    the duration of the transfusion (usually 2-3 hours for red cell
                    concentrates, and 30 minutes for an adult therapeutic dose of
                    platelets or a unit of fresh frozen plasma)
                    any special instructions, e.g. any medication required before or
                    during the transfusion
      • Requesting blood and blood components
      • Ensuring adequate documentation of the blood transfusion in the medical
          notes;
          Ensuring that if they remove a patient identity band for what ever purpose
          they themselves must take responsibility for replacing it.
          Ensuring that no transfusion takes place if the patient does not have a
          patient identity band

Medical and/or nursing and midwifery staff and Operating Department
Practitioners may carry out the following actions and be responsible for:
       • Taking blood samples for compatibility testing and cross match.
       • Explaining the risks and benefits of and indication for blood transfusion to
          patients. Acknowledging the patient's right to refuse to receive it.
       • Giving the patient information about alternatives to blood transfusion,
          including cell salvage.
       • Giving patients written information.
       • Inspection of the blood or blood component before its transfusion and
          return the unit to the hospital blood bank if any defects are found
       • Identity check of patient and unit of blood or blood component
       • Carrying out the procedure for the administration of blood and blood
          components
       • Monitoring patients during transfusion, and carrying out the appropriate
          actions in the event of adverse effects
       • Reporting of transfusion reactions or other incidents related to transfusion

All staff
        •   All grades of staff must attend annual Trust mandatory training in
            transfusion
       •    The individual who removes a patient identity band for what ever
            purpose must take responsibility for replacing it. Patients must wear
            identity bands throughout their stay.
       •    Reporting any incident or adverse event or “near miss” relating to
            any stage of the transfusion process in accordance with the Trust
            Incident Reporting Policy and Serious incident policy




                                          2
Notes on Student Nurses
      A student nurse in Year 3 can be the 2nd checker with an RN or midwife,
      provided the registered nurse/midwife is satisfied they are competent to do so
      and the student nurse can provide documentary evidence from their Practice
      Profiles that they are competent to fulfil this role.

Phlebotomists are responsible for taking blood samples for compatibility testing and
cross match. Individuals are responsible for:
          • 100% compliance with correct labelling on samples
          • Attending trust mandatory training
          • Ensuring that if they remove a patient identity band for what ever
               purpose they themselves must take responsibility for replacing it.
          • Reporting any incident or adverse event or “near miss” relating to any
               stage of the transfusion process in accordance with the Trust Incident
               Reporting Policy and Serious incident policy

Theatre Porters are responsible for:
         • The collection of blood, blood components and blood products. The
             porter will obtain blood/component from Blood Transfusion and will
             bring the blood/components straight to the satellite fridge in theatre.
         • Attending trust mandatory training

The Hospital Transfusion Committee is part of the Trust Risk structure (see below)
The Hospital Transfusion Committee will:
      Promote best transfusion practice throughout the Trust through the
      development of Trust protocols and guidelines based on national guidelines.
      Lead multi-professional audit of the use of blood components within the Trust.
      Promote the appropriate use of blood components.
      Promote the education and training of all clinical, laboratory and support staff
      involved in blood transfusion.
      Manage the Trust’s contingency planning for the shortage of blood
      components.
      Consult with local patient representative groups where appropriate.

The committee meets every three months.
The terms of reference for the Royal Free Hampstead NHS Trust Hospital
Transfusion Committee are given in appendix 10




                                          3
Hospital Transfusion Committee
    Governance Structure

           Trust Board




      Healthcare Governance
            Committee




         Risk Committee



           Clinical Risk
           Committee



       Hospital Transfusion
           Committee




               4
The Blood Safety and Quality Regulations 2005
Introduction
The Blood Safety and Quality Regulations, SI, 2005 No. 50 and The Blood Safety
and Quality (Amendment) (No.2) Regulations, SI, 2005 No. 2898, became effective
for the purposes of regulation on 8 November 2005.

These Regulations implement the requirements of the following EU Directives:

   •   Directive 2002/98/EC – setting standards of quality and safety for the
       collection, testing, processing, storage and distribution of human blood and
       blood components; and
   •   Directive 2004/33/EC – regarding certain technical requirements for blood
       and blood component.

Two further technical Directives were adopted by the European Commission on 30
September 2005. These are:

   •   Directive 2005/61/EC regarding traceability requirements and notification of
       serious adverse reactions and events; and
   •   Directive 2005/62/EC regarding Community standards and specifications
       relating to a quality system for blood establishments.

These Directives were transposed into UK legislation by the Blood Safety and Quality
(Amendment) Regulations 2006 No. 2013, which came into force on 31 August 2006.

The Blood Safety and Quality Regulations, SI, 2005 No. 50 apply to blood
establishments and to hospital blood banks. The 2006 Amendment Regulations
introduce requirements for a quality system in blood establishments and hospital
blood banks. They also extend traceability and record-keeping requirements to
“facilities” which may receive blood and blood components (i.e. care homes,
independent clinics, hospices, hospitals and other NHS facilities and services such
as satellite units, manufacturers of medicines and medical devices and biomedical
research institutes)

The Secretary of State is responsible for authorising and inspecting blood
establishments, monitoring compliance of hospital blood banks and carrying out
haemovigilance. The Secretary of State for Health has agreed that Medicines and
health Products Regulatory Agency (MHRA) (an executive agency of the Department
of Health) is to be the Competent Authority and perform these functions.

As of 8 November 2005 blood establishments are required to:

   •   submit an application for a blood establishment authorisation;
   •   maintain a quality system based on the principles of good practice;
   •   notify the competent authority of any serious adverse events and serious
       adverse reactions (haemovigilance /SABRE);
   •   ensure that all prospective donors of blood and blood components comply
       with the Regulations;
   •   maintain records to ensure full traceability from donation to the point of
       delivery for no less than 30 years; and
   •   be subject to an inspection from the competent authority at least once every
       two years.


                                         5
Hospital blood banks are required to:

   •   submit an application for a blood establishment authorisation if they collect
       autologous blood and blood components or perform secondary processing of
       blood component (for example, irradiation, washing, splitting etc.);
   •   maintain a quality system based on the requirements of Directive
       2005/62/EC;
   •   notify the competent authority of any serious adverse events and serious
       adverse reactions (MHRA via SABRE)
   •   confirm compliance with the requirements of the directives by submitting an
       annual compliance report to the Competent Authority; and
   •   maintain records to ensure full traceability from donation to the point of
       delivery for not less than 30 years.

Impact of the Regulations on the Trust
Please note that breaches of the principal regulations are criminal offences.

   •   Processing activities
       The only processing activity which may be performed legally under the
       regulations by the hospital blood bank is thawing of components.

   •   Quality Systems
       The hospital blood bank must have:
                o Standard Operating Procedures (SOP’s)
                o A Quality Manager
                o Cold Chain audit

   •   Education and Training
       All staff that are involved in the blood transfusion process must receive
       induction training and an annual update (including clinical staff) and be
       competency assessed. All training records must be available for inspection by
       MHRA.

   •   Adverse Event Reporting
       All staff should report any “near miss”, incident or adverse event relating to
       any stage of the transfusion process in accordance with the Trust Incident
       Reporting Policy and Serious incident policy. All serious events and reactions
       are to be reported to the MHRA Serious Adverse Blood Reactions & Events
       (SABRE) via the MHRA web site.

   •   Traceability
       The Trust must have unambiguous evidence of the fate of all blood
       components and also keep the records for 30 years. To achieve this, the
       Trust has adopted a system that uses a three part compatibility and
       traceability tag (See below). The responsibility for achieving 100% traceability
       lies with the person administering the blood. The traceability tag must be
       completed and returned to the blood bank.




                                          6
      Compatibility and traceability tag in use in the Royal Free
                       Hampstead NHS Trust




Consent

                               7
Introduction
       In most circumstances treatment may only be given with the patient’s
       consent. Medical and nursing staff have a duty to give patients an explanation
       of the nature, purpose, effects and risks of medical treatment and to obtain
       the patients verbal or non-verbal consent (e.g. offering arm to allow blood to
       be taken) before administering such treatment. The patient must have the
       capacity to understand the information that has been given and be able to
       make a decision.
       "It is a general legal and ethical principle that valid consent must be obtained
       before starting treatment or physical investigation, or providing personal care,
       for a patient. This principle reflects the right of patients to determine what
       happens to their own bodies, and is a fundamental part of good practice. A
       health professional who does not respect this principle may be liable both to
       legal action by the patient and action by their professional body." DOH
       Guidance on Consent Health Service Circular 2001/023
Requirements
       When giving a blood transfusion, it is acceptable to obtain the patients verbal
       consent but a note of the consent discussion should be made in the medical
       records. Patient information leaflets are available in several languages from
       the Specialist Practitioner of Transfusion (SPOT) and can also be
       downloaded from the blood transfusion website on FreeNet. The discussion
       and giving of an information leaflet should take place in a timely manner prior
       to transfusion e.g. at Pre-assessment clinic.
Exceptions
       The exceptions to obtaining informed consent are:
                Emergency situations in which a patient is not able to give consent
                and where to withhold treatment would endanger a patient's life or
                health.
                Where the patient lacks the capacity to give consent and is in need of
                medical care, and that it is the view of the treating clinician that
                treatment is in the patient’s best interest (i.e. to save life, prevent
                deterioration or provide an improvement in a person’s health).
Withdrawal of Consent
       Patients who have consented may withdraw such consent at any time. In
       such circumstances the nurse should inform the prescribing or duty doctor.
       The doctor and nurse should review the situation with the patient and a clear
       note recorded of that discussion and the decision.


Patient’s who refuse blood product transfusion
       For the management of Jehovah Witnesses or other patients who refuse
       blood product transfusion please refer to the Trust policy for the Jehovah’s
       Witness undergoing surgery. All patients refusing blood product transfusion
       must sign the form for refusal of blood product transfusion. Please note that
       replacement forms are available from the Specialist Practitioner of
       Transfusion and can also be ordered quoting reference RF1031. The Policy
       for patients who refuse blood transfusion can be found on FreeNet.




Transfusion

                                          8
Prescribing blood and blood components
Blood may only be transfused on prescription by a registered medical practitioner.
Blood transfusions should ordinarily be prescribed using the blood component
prescription sheet (RF671C) in ballpoint pen. Other solutions (crystalloids or colloids)
must not be prescribed on this sheet.
If a patient has special requirements i.e. requires CMV negative and/or irradiated
blood components (See appendix 7), a Special Requirements form must be filled in.
The Trust Special Requirements form is available via the Blood Transfusion
laboratory site on FreeNet as an E-form that can be filled in on-line or as a blank form
that can be downloaded from there. It also available in paper form on the
Haematology wards. All other types of Special Requirements must be discussed
with the Blood bank and the Transfusion Consultant

Decision to Transfuse
The decision to transfuse a patient should be taken by the most senior medical
practitioner available at the time, usually a Specialist Registrar or above.

Requesting
Transfusions of blood, blood components and blood products must be requested
from the Blood Transfusion laboratory on an individual named patient basis.
Requests for blood will normally be made by medical staff but it may be appropriate
for non-medical staff to request blood in some circumstances. However only medical
staff may prescribe blood, blood components or blood products.

Why send a Group and Save Sample (Group and Screen, Type and Screen)
  • A transfusion is possible but unlikely.
  • Samples are tested to determine blood group and are screened for the
      presence of atypical antibodies. The sample is saved for 7 days (or longer if
      requested) in case a transfusion is required. The advantages of this request
      are that the antibody status is known in advance. Where red cell allo-
      antibodies are identified, antigen negative units are ordered and reserved for
      cross-matching if required.
  • Uncross-matched ABO compatible blood can be transfused relatively safely in
      an emergency (See Massive Haemorrhage Guidelines) if the antibody screen
      is negative. The fact that the sample is stored in the lab eliminates the
      problem of sample transit time, thus allowing more time for a full cross-match
      if required later.

Why request a Cross-match
      • A transfusion is certain or highly likely.
      • The patient’s blood group is determined and the serum is screened for
         atypical antibodies. The patient’s serum is also compatibility tested
         against samples of red cells from ABO compatible donor units.
         Compatible units are reserved in the issuing fridge for 48hrs from the
         “required by” date.

Standard Blood Order Schedule for Elective Procedures
      • The SBOS sets out which surgical procedures require G&S and which
          require cross-matching and how many units are recommended. The
          SBOS is regularly reviewed by the Hospital Transfusion Committee. It can
          be found on the Blood Transfusion Laboratory site on FreeNet and is also
          on the back of the transfusion request form
Timing of Transfusion requests


                                           9
       •   For elective procedures - minimum of 24 hours during routine hours.
       •   Non urgent “top-up” e.g. for symptomatic anaemia – minimum of 12 hours
           during routine hours.
       •   Urgent transfusion - Full cross-match from G+S sample already in lab-45
           minutes.
       •   Urgent transfusion - Full cross-match from G+S sample not already in lab-
           45 minutes from receipt of specimen.

Timing of Transfusion Requests when patients have been previously
transfused:

       If the patient has been transfused
                                                   The sample must be taken within
                within the previous
                   3 -14 days                          24 hours before transfusion
                  14 -28 days                          72 hours before transfusion
               28 days - 3 months                       1 week before transfusion


The Collection of Blood Samples for Pre-transfusion Compatibility Testing
Positive patient identification
The patient must be positively identified. One of the major causes of incorrect blood
component transfused is the failure of the identity check at phlebotomy. Please make
every effort to correctly identify the patient.
       In-patients
            • At the time of taking the blood sample the conscious patient must be
                asked to state his/her full name and date of birth.
            • This should then be checked with the patient’s identity band and the
                request form to make sure that the details entered are identical. (Any
                individual removing a patient identity band for what ever purpose must
                themselves take responsibility for replacing it).
            • The blood sample should be taken using the appropriate sample tube,
                and the tube accurately labelled at the patient’s bedside at the time
                the blood sample is taken, with the patient’s full name, date of birth,
                gender and hospital number and should also be signed by the person
                taking the sample.

       Patients who are unconscious or otherwise compromised
           • At the time of taking the blood sample check the patient’s identity
              band and the request form to make sure that the details entered are
              identical. (Any individual removing a patient identity band for what
              ever purpose must themselves take responsibility for replacing it).
           • The blood sample should be taken using the appropriate sample tube,
              and the tube accurately labelled at the patient’s side at the time the
              blood sample is taken, with the patient’s full name, date of birth,
              gender and hospital number and should also be signed by the person
              taking the sample.




                                            10
      Patients without wrist bands in out-patients, the pre-assessment clinic
      and the accident and emergency department
         • At the time of taking the blood sample the patient must be asked to
             state his/her full name and date of birth.
         • Ensure that the name and date of birth given matches the information
             on the request form
          • The blood sample should be taken using the appropriate sample tube,
             and the tube accurately labelled at the patient’s side at the time the
             blood sample is taken, with the patient’s full name, date of birth,
             gender and hospital number and should also be signed by the person
             taking the sample.
          • For unidentified, unconscious patients in the Accident and Emergency
             department, a hospital number must be allocated to identify the patient
             as soon as possible. Please also specify the patient gender. i.e.
             unknown male or unknown female. Attach an identity band to the
             patient and ensure that when the patient’s details become known that
             the blood bank is informed.

             Sample containers must not be pre-labelled before the specimen is
             taken. The label should be written in ink and all the details written
             legibly. Patient sticky labels must not be used.

             PLEASE NOTE THAT THE BLOOD BANK WILL REFUSE TO
             PROCESS INCORRECTLY LABELLED SAMPLES. THEY WILL
             ALSO REFUSE TO PROCESS SAMPLES LABELLED WITH
             STICKY LABELS. NO EXCEPTIONS WILL BE MADE.

             Samples must be labelled and signed by the person who bled the
             patient. The signature denoted responsibility for the positive
             identification of the patient and that it is the identified patient’s
             blood in the sample bottle.

Please note that order communication in the Care Record system will not print
a sample label for transfusion specimens but will print a request form. You
must label the sample by hand. Please also note that if you require CMV
negative or irradiated blood components you must complete the Blood
Transfusion Laboratory Special Blood Products Requirements form. This form
is available on 4WB and 4S and 12EB. There is also an Electronic form which
can be found on FreeNet on the Blood Transfusion Laboratory site. You can
also download and print out a copy of the form from there. Please see
appendix 7. Requests for all other types of special requirements must be
discussed with the Blood Transfusion Laboratory

Request form for Blood Transfusion
     The Transfusion request form must have:
          • Patient’s forename and surname
          • Hospital number
          • Date of birth
          • Ward or location
          • Date of collection
          • Requesting doctor’s name and bleep number
          • Consultant
          • Indication for request
          • Time and date required

                                        11
Collection of Blood or Blood Components from the Blood Bank
Staff who collect blood or blood components (except Human Albumin Solution) must
have received documented training (See appendix 1).

Pre transfusion check
          • Check that the blood is correctly & legibly prescribed on the pink blood
              component prescription sheet (RF671C);
          • Check that the patient has patent IV access;
          • Check and document baseline observations.
          • Discuss reason for the transfusion with the patient
          • The person collecting the blood product must take the pink blood
              component prescription sheet (RF671C), or a document with the
              patient’s Hospital number, date of birth and full name to the blood
              bank.

Checking in the Blood Bank
         • The person collecting the component must check the details (Hospital
             number, full name, and date of birth) on the blood product prescription
             form (RF671C) or other document against:
                 • The details on the traceability and compatibility tag
                 • The details in the Blood Bank’s copy of the compatibility form
                    in the folder
         • Sign and record the date and time of collection on the copy of
             compatibility form in Blood Bank.

Administration of blood and blood components
The checking of the blood or blood component must be undertaken by two members
of staff and must be done at the patient’s bedside.

The first checker must be a Qualified Nurse (RN/RSCN/Midwife) who must have
successfully completed the Trust training and assessment in IV drug administration
or a Doctor and who have received mandatory transfusion training
The second checker can be Qualified Nurse or Doctor or ODP or a Year 3 student
nurse who has received mandatory transfusion training.

Compatibility check
     Pre-administration
     Step 1: Check Expiry date of component. Check pack for leaks,
     discolouration or clumping. Return to Blood bank if any doubts.
     Step 2: Check the component. Check for any special requirements e.g. CMV
     negative, irradiation and any concomitant drugs e.g. diuretics
     Step 3: Ask the patient their surname, forename, date of birth. Ensure that
     the patient has a wristband. No wrist band = no transfusion
     Step 4: Check that the information on the compatibility and traceability tag
     matches all the details on the blood component and the blood product
     prescription form (RF671C).
     Step 5: Check that the surname, forename, date of birth and hospital number
     on the patient’s wrist band and the compatibility and traceability tag match.

If there are any discrepancies. DO NOT PROCEED. Contact the Blood Bank.




                                         12
Documentation
       Both members of staff who checked the patient’s identity and the blood
       component must sign:
            a) The sticky label on the compatibility and traceability tag and place
                the label in the patient’s notes.
            b) The prescription chart with the date and start time of the
                transfusion.
            c) Then complete the date, time and sign the detachable (bottom) part
                of the compatibility and traceability tag and detach it from the
                blood/component bag and place it in the Blood Tag Collection box
                on your ward or unit.

Retaining empty blood component bags on the ward
When the unit has been completed and the detachable section of the compatibility
and traceability tag has been removed for return to Blood Bank, the empty bag must
be disposed of in a clinical waste bag if there are no signs of a transfusion reaction.
Only retain the empty bag if the patient has had a transfusion reaction, a suspected
transfusion reaction or if the patient had any unusual symptoms during the
transfusion.

Monitoring the Transfusion
      • The patient must be observed carefully for 15 minutes after each unit has
          been connected. During this time the blood should be infused slowly.
      • The patient's temperature, pulse, respiration, blood pressure and general
          condition should be recorded at 15 and 30 minutes after the start of each
          unit, and if there no problems, observations can be done hourly
          throughout transfusion and then checked at the end of the transfusion.
          See Table below
      • Report any unusual symptoms that occur during the transfusion
      • Observe and report any dark urine passed.
      • See below for the Management of Transfusion Reactions

                                    At 15 and 30
                                                                          At the end
                    Before the      minutes after     Hourly during
 Timings                                                                    of the
                   transfusion       the start of      transfusion
                                                                         transfusion
                                      each unit
 Temperature
 Blood
 Pressure
 Pulse Rate
 Respiration
 Rate
 Rate of Flow           NA                                                    NA


Storage of blood and blood components and time limits.
Blood must only be stored in a blood refrigerator. Blood must never be stored in the
ward refrigerators with the exception of the approved and monitored blood
refrigerators. Blood refrigerators must only be used to store blood. They must not be
used to store anything else. There is one exception to this and that is the neonatal
giving sets that are stored with the emergency neonatal blood in the labour ward

                                          13
fridge. The maximum transit time of blood components (except platelets) between
fridges is 30 minutes. The exceptions to this are:
    • Blood components transferred to the RNTNE and the satellite dialysis units by
        the Blood bank where a validated blood component transport box is used.
        See appendix 2 and 3
    • Blood components being transferred to another hospital with a patient. See
        appendix 5

              Red Cells
              Number of donors per pack = 1
              Volume - average 282mls. Range 180-350mls
              Must be stored at 4oC ± 2oC
                 • Complete the transfusion of the unit within four hours after it is
                    removed from controlled temperature storage (CTS).
                 • A red cell unit that has been out of CTS for longer than 30
                    minutes should not be accepted back into stock by the blood
                    bank, unless there is a validated local procedure to ensure that
                    any unit returned to blood bank stock is suitable for
                    transfusion.
                 • Red cell units must not be warmed other than in an approved
                    device, nor left in sunshine or near a heat source.
                 • Use a blood administration set. Change the administration set
                    every 12 hours for continuing transfusion and on completion of
                    the transfusion.

              Platelets
              Pooled
                 Number of donors per pack = 4
                 Volume – average 310mls. Range 250-400mls
              Apheresis
                 Number of donors per pack = 1
                 Volume – average 215. Range 180-300mls
              Must be stored at 22oC ± 2oC
              Start infusion immediately
              Infusion time 30 minutes maximum
              Use a blood administration set and use a fresh set when administering
              each infusion of platelets. Do not administer platelets through a giving
              set that has been used to administer blood.

              Standard FFP
              Number of donors per pack = 1
              Volume - average 273mls. Range 240-300mls
              Infuse immediately
              Infusion time 4 hours maximum
              Use a blood administration set
              Cryoprecipitate
              Number of donors per pack = 5
              Volume - average 150mls. Range 140-165mls
              Infuse immediately
              Infusion time 4 hours maximum
              Use a blood administration set




                                         14
If a delay occurs between the arrival of blood onto the ward and commencement of
the transfusion the blood should be returned to the Transfusion Laboratory within 30
minutes of collection. Blood returned to the laboratory outside this period must be
wasted by the laboratory as it would be unsafe to re-refrigerate.
If a delay occurs between the arrival of any other blood component (Platelets, FFP or
cryoprecipitate) and the commencement of transfusion, return it immediately to the
Transfusion laboratory



Cannulae
   There is no minimum or maximum size of cannula for transfusion. The size of
   cannula chosen should depend on the size of the vein and the speed at which
   the blood is to be transfused.

Infusion pumps
       Only electronic infusion pumps that are specified as safe with blood
       components by the manufacturer must be used and the manufacturer’s
       instructions must be strictly followed.

Blood warmers
      Hypothermia impairs blood clotting. Studies in surgical patients have found an
      association between hypothermia at the end of surgery and an increased
      incidence of post-operative infections and myocardial ischaemia.
      Hypothermia during surgery should be avoided. Blood and other infused fluids
      should be warmed. Rapid infusion of cold fluids (> 100 ml/minute) has been
      reported to cause potentially lethal cardiac arrhythmias. Infusion through a
      central catheter terminating in or near the right atrium may increase the risk.
      Only CE-marked commercial blood warmers should be used and the
      manufacturer’s instructions must be strictly followed.
              Please note that some fluid warmers are marked for use as blood
              warmers and but can operate at up to 43°C.
              Blood must only be warmed to a maximum of 42ºC.
              Blood products must NOT be warmed by improvisations such as
              putting the pack into hot water, in a microwave, or on a radiator,
              as uncontrolled heating can damage the contents of the pack.

Blood component spillages
Any spillage of blood must be cleared as per the policy for blood and body fluid
spillage. See the Infection Control manual on FreeNet.




                                         15
Management of Transfusion Reactions
(Source: The Handbook of Transfusion Medicine. 4th Edition. Editor DBL
McClelland. TSO, London. 2007)

All transfusion reactions must be reported to the Blood
Transfusion Laboratory.
Acute life-threatening complications of transfusion
These are: acute haemolytic transfusion reaction; reaction to infusion of a bacterially
contaminated unit; transfusion-related acute-lung injury (TRALI); acute fluid overload
and severe allergic reaction or anaphylaxis. Serious or life-threatening acute
reactions are rare but new symptoms or signs that appear while a patient is being
transfused must be taken seriously as they may be the first warnings of a serious
reaction. It can be difficult to determine the type of reaction in the early stages.

The recognition and management of acute transfusion reactions. (See
flow chart below)
Acute haemolytic reaction
Incompatible transfused red cells react with the patient’s own anti-A or anti-B
antibodies and cause an acute severe clinical reaction The infusion of ABO-
incompatible blood is most commonly due to errors in taking or labelling the sample,
collecting the wrong blood from the fridge, or failure to carry out the required checks
immediately before transfusion of the pack is started. If red cells are mistakenly
administered to the ‘wrong’ patient, the chance of ABO incompatibility is about one in
three. The reaction is usually most severe if group A red cells are infused to a group
O patient. Even a few millilitres of ABO incompatible blood may cause symptoms
within a few minutes that will be noticed by a conscious patient. However, if the
patient is unconscious or cannot communicate, the first signs of the reaction may be
bleeding, tachycardia, hypotension or hypertension. Acute haemolysis may also
occur following infusion of plasma-rich components, usually platelets or FFP,
containing high-titre anti-red- cell antibodies, usually anti A or B.

Management
        • Stop the transfusion.
        • Maintain venous access.
        • Resuscitate with crystalloid fluid.
        • Consider inotrope support if hypotension is prolonged.
        • Take blood cultures and samples for culture from component pack.
        • Inform the Blood Bank.
        • Seek urgent critical care and haematology advice.
        • Admit to ITU if possible.

Infusion of a blood pack contaminated by bacteria
Likely to cause a very severe acute reaction with rapid onset of hyper- or
hypotension, rigors and collapse. The signs and symptoms may be similar to acute
haemolytic transfusion reactions or severe acute allergic reactions. Bacterial
contamination of blood components is rare, but is more often reported with platelet
concentrates (stored at 22°C) than with red cells (stored at 4–6°C). Examination of
the pack (discoloration. smell and gram stain) may rapidly confirm the diagnosis.




                                          16
Organisms associated with contamination include Staphylococcus epidermidis,
Staphylococcus aureus, Bacillus cereus, Group B streptococci, E. coli, Pseudomonas
species and other gram negative organisms.


Management
As for acute haemolytic reaction, and administer a combination of antibiotics thatwill
be active against the range of bacteria that may be involved. In the absence of expert
microbiology advice it would generally be appropriate to follow the local protocol for
antibiotic management of sepsis in neutropenic patients. (i.e. a combination of broad
spectrum antibiotics given IV. Ensure good anti-staphylococcal and gram negative
cover)

Transfusion-related acute-lung injury (TRALI)
Typically within six hours of a transfusion, the patient develops breathlessness and
non-productive cough. The chest X-ray characteristically shows bilateral nodular
infiltrates in a batwing pattern, typical of acute respiratory distress syndrome. Loss of
circulating volume and hypotension are common. The patient may or may not have
fever or chills. Monocytopenia or neutropenia may be seen.

Differential diagnosis: It may be very difficult to distinguish TRALI from other non-
cardiogenic pulmonary oedema or cardiac failure.

Management
  • Seek urgent critical care and haematology advice.
  • Admit to ITU if possible.
  • Measure CVP
  • Treatment is that of adult respiratory distress syndrome from any cause.
  • Diuretics should be avoided.
  • Steroids are of uncertain benefit.
  It is often found that plasma of one of the donors contains antibodies that react
  strongly with the patient’s leucocytes. The implicated donors are almost always
  parous women. It is important to report any case of TRALI to the transfusion
  laboratory so that an implicated donor can be contacted and, if appropriate, taken
  off the donor panel.

Fluid overload (transfusion-associated circulatory overload, TACO)
When too much fluid is transfused or the transfusion is too rapid, acute left ventricular
failure (LVF) may occur with dyspnoea, tachypnoea, non-productive cough, raised
JVP, basal lung crackles, frothy pink sputum, hypertension and tachycardia.

Management
The transfusion should be stopped and standard medical treatment, including diuretic
and oxygen, given.
Note: Patients with chronic anaemia are usually normovolaemic or hypervolaemic,
and may have signs of cardiac failure before any fluid is infused. If such a patient
must be transfused, each unit should be given slowly with diuretic (e.g. frusemide
20–40 mg), and the patient closely observed. Restricting transfusion to one unit of
red blood cells in each 12-hour period should reduce the risk of LVF. Volume
overload is a special risk with 20% albumin solutions.

Allergic reactions
Anaphylaxis



                                           17
A rare but life-threatening complication usually occurring in the early part of a
transfusion. Rapid infusion of plasma is one cause. Signs consist of hypotension,
bronchospasm, periorbital and laryngeal oedema, vomiting, erythema, urticaria and
conjunctivitis. Symptoms include dyspnoea, chest pain, abdominal pain and nausea.

Anaphylaxis occurs when a patient who is pre-sensitised to an allergen producing
IgE antibodies is re-exposed to the particular antigen. IgG antibodies to infused
allergens can also cause severe reactions. A few patients with severe IgA deficiency
develop antibodies to IgA and may have severe anaphylaxis if exposed to IgA by
transfusion. If the patient who has had a reaction has to have further transfusion, it is
essential to seek advice from the blood bank as there is a real risk of a repeat
reaction unless blood components are specially selected.

Management
  • Treat as for anaphylaxis
  • Discontinue transfusion and return unit to the transfusion laboratory
  • If the patient who has had a reaction has to have further transfusion, it is
     essential to seek advice from the blood bank as there is a real risk of a repeat
     reaction unless blood components are specially selected.

Less severe allergic reactions
Urticaria and/or itching within minutes of starting a transfusion are quite common,
particularly with components including large volumes of plasma, e.g. platelet
concentrates and FFP. Symptoms usually subside if the transfusion is slowed and
antihistamine is given (e.g. chlorpheniramine 10 mg, by slow intravenous injection or
intramuscular injection in patients who are not thrombocytopenic). The use of
Octaplas may sometimes ameliorate recurrent reactions to FFP.

Management
The transfusion may be continued if there is no progression of symptoms after 30
minutes. Chlorpheniramine should be given before transfusion if the patient has
previously experienced repeated allergic reactions. If signs and symptoms fail to
respond to this, seek advice from haematologist.

Febrile non-haemolytic transfusion reactions (FNHTR)
Fever or rigors during red cell or platelet transfusion affect 1–2% of recipients, mainly
multi-transfused or previously pregnant patients. These reactions are probably less
frequent with leucodepleted components. Features are fever (> 1.5°C above
baseline), usually with shivering and general discomfort occurring towards the end of
the transfusion or up to two hours after it has been completed.

Management
Most febrile reactions can be managed by slowing or stopping the transfusion and
giving an antipyretic, e.g. paracetamol (not aspirin). These reactions are unpleasant
but not life threatening, but it is important to remember that the fever or rigors could
be the first warning of a severe acute reaction.




                                           18
                        Flow Chart
The recognition and management of acute transfusion reactions




                             19
Delayed complications of transfusion

Delayed haemolytic transfusion reaction (DHTR)
DHTR is a haemolytic reaction occurring more than 24 hours after transfusion, in a
patient who has been immunised to a red cell antigen by previous transfusion or
pregnancy. The antibody may be undetectable by routine blood bank screening.
However, red cell transfusion can cause a secondary immune response that boosts
the antibody level. Antibodies of the Kidd (Jk) and Rh systems are the most frequent
cause of such delayed haemolytic reactions. Features, occurring usually within 1–14
days of transfusion, may include falling haemoglobin concentration, unexpectedly
small rise in Haemoglobin, jaundice, fever and rarely haemoglobinuria or renal
failure.

Management
  • Investigations include haemoglobin level, blood film, LDH, direct antiglobulin
     test,
  • renal profile, serum bilirubin, haptoglobin and urinalysis for haemoglobinuria.
  • Renal function should be closely monitored.
  • The group and antibody screen should be repeated and the units should be
     re-cross-matched using both pre- and post-transfusion samples.
  • Specific treatment is rarely required, although further transfusion may be
     needed.
  • The blood bank should be notified immediately.

Transfusion associated graft-versus-host disease (TA-GvHD)
This is a rare but serious complication, due to the engraftment and proliferation of
transfused donor lymphocytes. These damage recipient cells that carry HLA
antigens. The skin, gut, liver, spleen and bone marrow are affected, usually one to
two weeks following a transfusion, initially causing fever, skin rash, diarrhoea and
hepatitis. The condition is usually fatal. Patients at risk are immuno-compromised or
those who receive transfusion from a first- or second-degree relative (due to the
sharing of an HLA haplotype).
It is essential that all patients at risk of GvHD receive only blood components
that have been irradiated to inactivate any donor lymphocytes. See Appendix 7
– Special Blood product requirements

Post-transfusion purpura (PTP)
This is a rare but potentially lethal complication of transfusion of red cells or platelets.
It is more often seen in female patients. It is caused by platelet-specific allo-
antibodies. Typically five to nine days after transfusion, the patient develops an
extremely low platelet count with bleeding.

Management
Seek specialist advice from haematologist.
High-dose intravenous immunoglobulin is the current treatment of choice with
responses in about 85% of cases; there is often a rapid and prompt increase in the
platelet count. Steroids and plasma exchange were the preferred treatments before
the availability of IVIgG, and plasma exchange in particular appeared to be effective
in some but not all cases. Platelet transfusions are usually ineffective in raising the
platelet count, but may have to be given in large doses in the attempt to control
severe bleeding in the acute phase, particularly in patients who have recently
undergone surgery, before there has been a response to high-dose IVIgG. There is
no evidence that platelet concentrates from HPA 1a negative platelets are more
effective than those from random donors in the acute thrombocytopenic phase, and


                                            20
the dose of platelets may be more important than the platelet type of the donor
platelets. There is no evidence to suggest that further transfusions in the acute phase
prolong the duration or severity of thrombocytopenia.
Iron overload
Patients with beta thalassaemia are the most likely to have iron overload problems
but patients with sickle cell disease and those with other transfusion-dependent
conditions may also be affected. Each unit of red cells contains about 250 mg of iron.
Since iron excretion is very limited, accumulation in the body causes toxic effects
after 10–50 units have been transfused. These patients require life-long iron
chelation therapy from the age of two to three years. Those who can comply well with
iron chelation therapy have a 90% chance of surviving into the fourth decade of life;
those who comply poorly have a high mortality rate in the third and fourth decade of
life, usually due to complications of iron overload (cardiac disease, cirrhosis and
diabetes mellitus).

Management
Iron chelation therapy: A conventional regime would be desferioxamine 30–50 mg
subcutaneously by slow infusion overnight using a syringe driver at least five times
per week.

Infections transmissible by transfusion
Infection screening of donations
Donated blood units are tested for infective agents that are known to be transmitted
by blood and to have the potential to cause significant disease, and for which there
are practicable and effective tests. There are other blood-transmissible infective
agents that are known to occur in the normal population, and therefore among blood
donors, but which have not been associated with any illness, and further infections
may emerge as transfusion risks. Every donation is tested for hepatitis B surface
antigen, hepatitis C antibody and RNA, HIV antibody, HTLV antibody, and syphilis
antibody. Tests for antibodies to malaria, T. cruzi and for West Nile virus RNA may
be used when travel may have exposed a donor to risk of these infections. Some
donations are tested for cytomegalovirus antibody to meet the needs of specific
patient groups (see appendix 7). The epidemiology of infections in the population and
among donors is monitored by the Health Protection Agency in order to inform future
testing strategies for further risk reduction.

Frequency of transfusion transmitted infections in tested donations – estimated and
observed (Tables 1 and 2)

On very rare occasions screening fails to detect the target infection in a donation.
The risk of this can be estimated by calculation and also from the actual reported
number of infections associated with transfusion. The estimated frequency of HBV,
HCV and HIV infectious donations entering the UK blood supply in 2002–2003 is
shown in Table 1. About three million blood component units are supplied (though all
are not necessarily transfused) each year in the UK, so these estimates would
predict that about one donation per two years could transmit HIV, seven donations
per year could transmit hepatitis B, and one donation per seven years could transmit
hepatitis C. The number of transfusion-transmitted infections reported to SHOT is
shown in Table 2.




                                          21
Hepatitis B
Hepatitis B can cause severe disease, and although most infected patients recover
without serious complications, in some cases infection persists as a chronic carrier
state. Patients who are immunosuppressed (e.g. those with leukaemia, cancer or
transplant recipients) are more likely to go on to become carriers, often with high
levels of infection.

Tests for hepatitis B surface antigen (HBsAg) are extremely effective; there are very
rare instances, however, in which HBsAg may be undetectable in a donor who is
actually infectious. The role of tests for HBV DNA is still uncertain.

Hepatitis C
Although many people infected with hepatitis C are asymptomatic, some develop
chronic liver disease and some will eventually progress to cirrhosis or hepatocellular
carcinoma. Serological tests to detect hepatitis C virus infection were introduced in
1991. An additional test for hepatitis C RNA was introduced in 1999. It is estimated
that the current risk of a blood unit infected with hepatitis C entering the UK blood
supply is about 0.05 per million (or 1 in 22 million).

Human T-cell lymphotropic virus types I and II
HTLV infection is occasionally detected in blood donors in the UK; usually these are
individuals from countries where the infection is endemic or the female sexual
partners of men from these areas. Only a small proportion, less than 5%, of those
infected become ill, but infection has been associated with a chronic neurological
disorder (tropical spastic paraparesis) and a rare, aggressive malignancy (adult T-cell
leukaemia/lymphoma (ATLL)). These conditions may develop many years after
infection. All blood donations in the UK have been tested for antibody to HTLV I and
II since 2002. Four HTLV-transmitted infections have been identified in the UK since
1991, all of which received transfusions prior to the introduction of leucodepletion of
all components in 1999.

Cytomegalovirus (CMV)
See appendix 7.

Hepatitis A
Hepatitis A is caused by a non-enveloped virus that is resistant to current methods of
pathogen inactivation of blood components. Transfusion transmission of hepatitis A is
extremely rare. In the UK, there have been four reports of transmission over the past
25 years.

Human parvovirus B19
Human parvovirus B19 is a prevalent, seasonal, non-enveloped virus that is quite
resistant to current methods for pathogen inactivation of blood components. It can be
transmitted via transfusion. Clinically, infection is generally asymptomatic or causes
mild symptoms, but it can cause aplastic crisis in patients with sickle-cell disease,
thalassaemia, chronic haemolytic anaemia or red cell membrane defects. Infection in
the second trimester can lead to fetal anaemia, death or malformation.

West Nile virus
A mosquito-borne flavivirus infection causing encephalitis. Recent seasonal
epidemics have occurred in North America. West Nile virus can be transmitted by
blood donated during the viraemic phase. During the epidemic season, donors may
not give blood in the UK for 28 days after returning from an affected area unless a


                                          22
test for viral RNA is negative. There have been no cases transmitted by transfusion
in the UK and no infected donors have been detected to date.
Treponemal infections (syphilis)
There have been no reports of transfusion-transmitted syphilis in the UK in recent
years. All donations are screened for serological evidence of Treponema pallidum
infection.


Other bacterial infections
Despite all precautions, bacteria may occasionally enter a blood component pack, for
example in skin fragments arising from the venepuncture. To reduce this risk, the first
20 ml of the donation is diverted from the collection pack and used for all the
screening tests. Bacterial culture of platelet units is also being introduced, because a
transfusion contaminated with bacteria can result in fatal transfusion reactions.
Platelets are more likely to be associated with bacterial complications than red cells.
Skin contaminants such as staphylococci may proliferate in platelet concentrates
stored at 22°C. Bacteria identified in contaminated red cell transfusions are usually
strains that can grow in red cells stored at 4°C. Examples are Pseudomonas
fluorescens, an environmental contaminant, and Yersinia enterocolitica, which may
contaminate a donation taken during an episode of asymptomatic bacteraemia.

Malaria
Only five cases of transfusion-transmitted malaria (all due to Plasmodium falciparum)
have been reported in the UK in the past 25 years. In the US between 1993 and
1998, transfusion transmitted malaria (by several species of plasmodium) occurred
with a frequency between zero and 0.18/million units collected. Blood donor selection
procedures, and in some cases tests for malaria antibody, are used to identify and
exclude individuals whose blood could transmit malaria.

Chagas’ disease
This is a serious chronic multi-organ disease caused by Trypanosoma cruzi, and is
transmissible by transfusion. In the UK no cases transmitted by transfusion have
been reported; a small number of such cases have been reported in North America.
It is an important problem in parts of South America where the infection is endemic. A
negative test for antibody to T. cruzi allows the acceptance of donors at risk of
infection.

Variant CJD
Clinical features and epidemiology
Variant CJD (vCJD) was identified in 1996. It is a transmissible spongiform
encephalopathy (TSE) that is thought to be caused by the same agent as bovine
spongiform encephalopathy (BSE). This is an altered form of a normal protein called
prion protein. During the period of the BSE epidemic, the UK population was exposed
to the agent through consumption of beef. It is possible that there are healthy
individuals who could be carriers of the agent. vCJD affects people younger (median
age 29 years) than the long-recognised sporadic form of CJD. It also differs clinically,
presenting with behaviour disorders, depression and anxiety, followed by sensory
and coordination problems and progressive dementia. Survival from diagnosis is 6–
24 months. To date about 160 definite and probable cases of vCJD have been
reported in the UK, 14 in France, three in Ireland and single cases in a number of
other countries. The eventual number of cases that can be expected in the UK is
uncertain. Three possible transmissions of vCJD by blood transfusion have been
reported. One of the patients died of unrelated causes.



                                          23
vCJD precautionary measures taken by the UK blood and tissue services
Measures to minimise transmission by blood or tissues have been introduced as new
information has become available. It can be expected that further precautions will be
introduced. The measures summarised below have an important impact on both cost
and availability of blood for transfusion.

   •   Withdrawal and recall of any blood components, plasma derivatives, cells or
       tissues obtained from any individual who later develops variant CJD
       (announced December 1997).
   •   Importation of plasma from countries other than the UK for fractionation to
       manufacture plasma derivatives (announced May 1998, fully implemented
       October 1999).
   •   Leucodepletion of all blood components (decision announced July 1998, fully
       implemented autumn 1999).
   •   Importation of clinical FFP for patients born after January 1996, announced
       on 16 August 2003 and implemented by the end of June 2004, and extended
       to all patients under the age of 16 by July 2005.
   •   Exclusion of whole blood donors who state that they have received a blood
       component transfusion in the UK since 1 January 1980 (April 2004).
       Extended to whole blood and apheresis donors who may have received a
       blood component transfusion in the UK since 1 January 1980 (August 2004)
       and to any donors who have been treated with intravenous immunoglobulin
       prepared from UK plasma, or who have undergone plasma exchange
       procedures anywhere in the world.
   •   Exclusion of live bone donors who have been transfused since 1 January
       1980 (July 2005).
   •   Exclusion of blood donors whose blood has been transfused to recipients who
       later developed vCJD, where blood transfusion cannot be excluded as a
       source of the vCJD infection and where no infected donor has been identified
       (July 2005).
   •   Further measures may include the use of processes intended to remove any
       infectivity that may be present in blood and the use of donor screening tests,

Table 1. Estimate of the risk that a donation that is positive for HIV, hepatitis B
or hepatitis C may enter the blood supply

 Donations by                 HIV                    HCV                     HBV
                           Per million            Per million
                                                                     Per million donations
                           donations              donations
 All donors                   0.22                   0.05                    2.20
 New donors                   0.50                   0.19                    6.7
 Repeat donors                0.19                   0.03                    1.7

Rates of residual risk infection in UK blood donations 2002–3.
Calculated as described by Soldan K, Davison K and Dow B, Euro. Surveill. 2005 Feb
10(2):179.




                                           24
     Table 2. Frequency of reported serious hazards of blood transfusion in the UK

                                                                                        Events reported
                                    Events     Events reported per        Events
                                                                                         per 100,000
Event type                         reported    100,000 components        reported
                                                                                      components issued
                                  1996–2004     issued 1996–2004        2003–2004
                                                                                        2003 and 2004
Incorrect blood component
                                    1832                 7                 787                12
transfused(IBCT)
ABO incompatible
transfusions (all components         249                 1                  56                0.8
– included in IBCT)
Death as a result of IBCT             20                0.07                 3               0.04
Transfusion-related acute-
                                     162                0.6                 59                0.9
lung injury (TRALI)
Fatal TRALI                           36                0.1                  9                0.1
Acute transfusion reaction
                                     267                 1                  73                 1
(ATR)
Transfusion-transmitted
                                      49                0.2                  6                0.1
infection (including bacterial)
Total adverse
                                    2628                 10                994                14
reactions/events
Total transfusion-related
                                     100                0.4                 21                0.3
deaths


     Notes:
        • Data reported to the UK Serious Hazards of Transfusion Scheme, 1996 to 2004.
        • Data from unpublished UK studies indicate that individuals who receive a red cell
            transfusion in any year receive an average of four or five units. However, the
            distribution is skewed: most recipients receive two units, while a small minority
            receive much larger numbers.
        • The risk of experiencing an adverse event is greater in recipients of greater numbers
            of transfusions, but is not a simple function of the number of units received.
        • Over a period of eight years, 2628 events (not including ‘near misses’) have been
            reported to SHOT. During the same period, 27 million blood components were issued
            by the UK blood services. Using these figures, and the analysis of types of events
            undertaken annually by SHOT, the major risks of transfusion can be crudely
            calculated. Not all reported adverse reactions and events are included in the table.
        • The total number of blood component units issued by the blood services to hospitals
            is used as the denominator.
        • TRALI and severe allergic reactions (counted as ATRs) are some four to six times
            more likely to occur in relation to plasma and platelets than to red cells.
        • The table does not reflect the number of patients transfused or the number of
            transfusion episodes.
         •    The causal relationship between the observed reaction and the transfusion is often
              not clear cut.




                                                   25
Incident and Adverse Event Reporting

      In accordance with national guidance and legislation, the Trust is required to record all
      hazards, adverse events, and near misses whether they are major/minor, or clinical/non
      clinical; affecting one patient or many; related to patients, staff, students, contractors or
      visitors to the Trust; involving equipment, buildings or property.

      All incidents must be reported on the Trust’s unified incident reporting form. The degree
      of investigation will be dependent on the incident severity as determined by the severity
      matrix (see below) In addition, legislation requires that more serious incidents with
      wider implications be reported to various external agencies e.g. the Health and Safety
      Executive (RIDDOR/IRMER); National Patient Safety Agency; the Medicines and
      Healthcare products Regulatory Agency; Serious Hazards of Transfusion; NHS Estates.
      Appropriate senior managers and specialist clinicians, the Risk and Safety Department
      and Medical Electronics Department will be responsible for making such reports. These
      procedures are detailed in the Incident Reporting and Investigation Procedure
      which is available on FreeNet
      .

Definitions

        Incident              Any event or circumstance arising that could have or
                              did lead to unintended or unexpected harm, loss or
                              damage.
        Hazard                Something which has the potential to cause harm
        Harm                   Injury (physical or psychological), disease, disability,
                              or death as a consequence of the event. In the case
                              of incidents arising during patient care, harm can be
                              considered ‘unexpected’ if it is not related to the
                              natural cause of the patient’s illness or underlying
                              condition.
        Adverse event         An incident that led to harm loss or damage
        Near Miss             An incident where no immediate harm, loss or
                              damage was suffered, but if not detected could have
                              led to an adverse event.
        Red         category/ Incidents where the actual impact of the event is
        Significant risk      fatality or severe or where the likely potential impact
                              of a near miss would fall within these and there is a
                              high likelihood of reoccurrence.
        Amber       category/ Incidents where actual impact is moderate, or where
        Moderate Risk         the likely potential impact of a near miss is fatal or
                              severe with a low likelihood of recurrence or
                              moderate with a high likelihood of recurrence.
        Yellow/Green/         Investigations are locally managed, trends are
        Low/Very low risk     monitored and unresolved risks inform the divisional
                              risk registers.




                                               26
           Risk Severity Scoring
           Risk Severity Matrix: Risk = Consequence x Likelihood
           Step 1:                  Assess the actual consequence of the event
           Examine the description that most closely reflects the consequence of the event. Where more than one can be identified, the
           highest score should be chosen

Score           Grade       Impact on person affected (NOT an exhaustive list)                        Number     Impact on Service / organisation
                                                                                                      affected   / Reputation
  1             None        No obvious harm                                                             0-1      - No service disruption
                                                Slight cuts/bruising                                             - Low financial loss <£10k
  2             Minor       Non permanent harm (up to one month)                                                 - Litigation/Financial loss £11k -
                                                Increased LOS/level of care 1-7 days                             £50k
                                                Reversible medication error                            1–2       - <3 days local media publicity
                                                First aid treatment needed
                                                Soft tissue damage
  3         Moderate        Semi permanent harm (One month to one year)                                          - > 3 days local media publicity
                                               Known or suspected serious infection                              - Litigation £51k - £500k
                              (e.g. MRSA)                                                                        - Failure of support services
                                               Additional monitoring/l treatment required                        - Underperformance against other
                                               Required change in care plan                                         targets
                                                                                                       3-15
                                               Increased length of stay 8-15 days                                - Moderate business interruption
                                               Increased level of care 8-15 days                                 - Moderate environmental
                                               Fractured NOF                                                     implications
                                               Staff absence > 3 days                                            - Reportable to External agencies
                                                                                                                 (IRMER/SHOT/RIDDOR)
  4             Major       Major permanent harm                                                                 - Adverse national publicity
                                     Procedures involving the wrong body part                                    - Temporary service closure
                                     Haemolytic transfusion reaction                                             - Litigation £500k - £1million
                                     Retained instruments/ material after surgery                                - Intermittent failure of critical
                                     Infection resulting in permanent harm (e.g. hep C                           service
                            infection)                                                                 16- 50    - Underperformance against key
                                     Radiation dose significantly different than intended                        targets
                                     Infant abduction, or discharge to the wrong family                          - Reportable to External Agencies
                                     Serious sexual abuse of a patient                                           (NPSA/HSE/StHA)
                                     Increased length of stay > 15 days
                                     Increased level of care >15 days
  5        Catastrophic     Death/Multiple fatalities                                                            - International adverse publicity
                                                      Unexpected death of patient                                - Severe loss of reputation
                                                      Death of visitor, contractor or staff                      - Complete breakdown of critical
                                                      Affecting a number of people (e.g.                         services
                                                                                                       Many
                                                      screening issue)                                           - Significant underperformance of
                                                                                                       (>50)
                                                                                                                 key targets
                                                                                                                 - Significant overspend
                                                                                                                 - CEO or ministerial
                                                                                                                 resign/removal
                                                                                                                 - Litigation/Financial loss >£1 M

      Step 2 Assess the likelihood of the event recurring
      Examine what current controls are in place (e.g. training, guidelines etc) and given these current arrangements, assess the probability
      of the event occurring again

         Score              Frequency                                                  Description
            1                  Rare               The event may occur only in exceptional circumstances given existing controls
            2                 Unlikely            Not expected to occur given existing controls
            3                Possible             The event could recur occasionally given existing controls
            4                  Likely             The event will probably occur again given existing controls
            5              Almost Certain         The event will occur frequently given existing controls



      Step 3 Assess the potential consequence if the event happened again
      Where harm has not occurred and given the existing arrangements (e.g. training, staffing levels, equipment), use the table above to
      assess the potential consequence to the Trust or to a person if the event occurred again.

      Step 4                        Risk Score
      Likelihood                                                 SEVERITY / CONSEQUENCE
                                None (1)            Minor (2)       Moderate (3)     Major (4)                   Catastrophic (5)
        Rare (1)                    1                   2                    3                    4                      5
      Unlikely (2)                  2                   4                    6                    8                     10
      Possible (3)                  3                   6                    9                 12                       15
      Likely (4)                    4                   8                   12                 16                       20
      Almost certain (5)            5                   10                  15                 20                       25


                                                                             27
Appendices




     28
Appendix 1

Transfusion Training and Competency Policy
Introduction
This policy identifies the kinds of blood transfusion training the majority of Trust
employed staff will need to undertake as well as the frequency and duration of training.
It also clarifies responsibilities for the content, delivery, competency assessment,
monitoring and reporting of the training.

Statutory and Mandatory Transfusion Training requirements
Statutory and Mandatory Training is training that is essential for someone to safely
undertake a task or role to comply with legislation or Trust policies. For blood
transfusion the relevant documents that specify training are:
    • The Blood Safety and Quality Regulations 2005 (Statutory)
    • Better Blood Transfusion HSC 2002/009 (Mandatory)
The NHS Litigation Authority criteria for Blood Transfusion is based on the
implementation of the Health Service Circular, Better Blood Transfusion and the Safer
practice notice, Right patient, right blood.

The Blood safety and Quality Regulations 2005 requires that:
   • All members of staff that collect blood and blood components must have
      received training to do this, have documented evidence of training and receive
      regular update training.
   • Clinical staff must be aware that it is a legal requirement to report any adverse
      events or reactions to the Blood Bank for them to investigate and report to the
      MHRA and know the correct storage requirements for blood and components
      and to return any units that will not be transfused to the Blood Bank within 30
      minutes.
   • Clinical staff must be aware of the Blood Component Traceability scheme in the
      Trust and that the responsibility for achieving 100% for traceability lies with the
      person administering the blood or blood component.
The regulations are enforced by the Medicines and Healthcare products Regulatory
Agency (MHRA) and breaches of the principal regulations are criminal offences.

Better Blood Transfusion (HSC 2002/009) requires the Trust to:
   • Ensure that education and documented annual training on blood transfusion
       policies are administered to all health care staff involved in the process of blood
       transfusion and is included in the induction and orientation programmes for new
       staff.

Content and Delivery
Content of Trust Induction and mandatory training package.
  • Phlebotomy for blood transfusion
  • The correct collection of blood components from the blood bank
  • Correct administration of blood components
  • Performing observations on the patient being transfused
  • Blood component traceability
  • Correct storage and transport of blood components and time limits on
      administration
  • Recognition of acute transfusion reactions and their management and reporting
      them to the blood transfusion laboratory.
                                           29
Content of Phlebotomy for Transfusion package
  • Positive patient identification
  • Correct labelling

Content of Collecting Blood and Blood Components package
  • Correct documentation for identification of cross-matched components
  • Checking and signing out of blood and blood components in the blood bank
  • Correct storage and transportation of blood and blood components

Content of mandatory training for medical staff
  • Phlebotomy for transfusion
  • Types of request (Cross-match and group and save)
  • Timing of requests for cross-match
  • BBT2 minimum dataset to be recorded in notes
  • Outline of transfusion thresholds and strategies for reducing blood usage
  • Outline of management of adverse events
  • Blood bank contact information and where to find transfusion protocols and
      policies

This training will be classroom-based and will be principally delivered by the Specialist
Practitioners of Transfusion with other members of the Hospital Transfusion Team
deputising when required.


Frequency of Transfusion Training
Appropriate transfusion training must be included in the induction and orientation
programmes for new staff. All members of health care staff who are involved in the
process of blood transfusion must receive documented annual training on blood
transfusion policies.




                                           30
                                       Types of training

 Staff groups for
whom training and         Type of      Driver of statutory      Driver of           Frequency
   assessment             training           status          mandatory status       of training
    applicable
                                                                Better Blood
   Medical Staff,
                         Phlebotomy                          Transfusion HSC
   Phlebotomists,                      Blood Safety and                             Induction,
                             for                                 2002/009
  Nursing staff who                   Quality Regulations                             Annual
                         Transfusion                         Right patient, right
     undertake                               2005                                     update
                         presentation                              blood
    phlebotomy
                                                              NPSA/2006/014
                                                                Better Blood
                         Collection of
                                                             Transfusion HSC
                          blood and     Blood Safety and                            Induction,
                                                                 2002/009
  Theatre Porters           blood      Quality Regulations                            Annual
                                                             Right patient, right
                         components           2005                                   update,
                                                                   blood
                         presentation
                                                              NPSA/2006/014
                                                                Better Blood
    Nurses and
                         Mandatory                           Transfusion HSC
midwives, operating                     Blood Safety and                            Induction,
                         transfusion                             2002/009
     department                        Quality Regulations                            Annual
                           training                          Right patient, right
practitioners, student                        2005                                   update,
                           package                                 blood
nurses and midwives
                                                              NPSA/2006/014


Documentation and recording of training
All attendees of induction and mandatory update training are required to fill in a register
with their name, job title, ward or speciality and sign the entry. These details are then
recorded on the transfusion training registry database. A copy of the competency
assessment form must be sent to the Specialist Practitioners of Transfusion and be
recorded on the transfusion training registry database.




                                              31
Appendix 2
                     ROYAL FREE HAMPSTEAD NHS TRUST
                                 RNTNE

           Transporting and Accepting all blood for transfusion.

               Blood fridge is located in Theatre recovery area.
                   Out of hours via the 5002 bleep holder.

Blood for transfusion during normal working hours.

RFH staff will attend twice a week-Tuesday + Friday

Ad-hoc blood deliveries will be taken directly to theatre by the driver.
• A member of theatre staff will accept delivery
• The blood is taken out of the red bag and checked against the enclosed form to ensure
   details are correct.
• The BLOOD PRODUCT TRANSFER FORM should be completed and signed. This form is
   placed in the black folder by the Blood fridge for collection by blood transfusion staff
• The blood is placed in the blood fridge and the door firmly shut prior to leaving
• Please inform appropriate ward that blood has arrived.
• Contact for any queries is Senior Nurse in Theatres

Blood for transfusion outside normal working hours.
When blood arrives at the RNTNEH main entrance-:
•   The Front hall receptionist will bleep 5002 bleep holder who will immediately collect the
    blood which will be in a red bag.
•   The 5002 bleep holder will take the bag up to theatre recovery area.
•   The blood is taken out of the red bag and checked against the enclosed form to ensure
    details are correct.
•   There should be 3 forms;-
    1. The BLOOD PRODUCT TRANSFER FORM should be completed and signed. This
        form is placed in the black folder by the Blood fridge for collection by blood transfusion
        staff
    2. In one of the bags containing a blood unit there should be 2 forms-BLOOD
       TRANSFUSION-CROSSMATCH REPORT.
           • 1 should be placed in the black folder and completed when a blood unit is
              removed for patient transfusion
           • 2nd should be attached to the patients prescription chart and completed prior to
              commencing blood transfusion on the ward

•   The blood is placed in the blood fridge and the door firmly shut prior to leaving.

•   If the bleep holder is unable to collect the blood immediately she/he will arrange for a ward
    nurse (who has been instructed in the process) to take the blood to the blood fridge
    situated in Theatre recovery. It is the responsibility of the 5002 bleep holder to ensure the
    blood is stored appropriately and with minimal delay in the blood fridge and all paperwork
    has been completed.




                                                32
Appendix 3

Receipt of Blood onto the Satellite dialysis units. (Mary Rankin
Dialysis Unit and Highgate Dialysis Unit)
  •   Blood is delivered to the reception desk in a validated blood transfer box by the
      contracted taxi service (Day Lewis) from the Royal Free Hospital Blood Bank.

  •   It must be immediately transferred to blood fridge where it is received by the registered
      nurse who removes the blood from the box and places it in the appropriate drawer in
      the Blood Fridge.

  •   The transfer form must be completed at the time of receipt and a photocopy returned to
      the Royal Free Hospital blood bank.

  •   The receipt of the blood is entered in the Blood Log Book, all requested details are
      completed (patients full name, date of birth, donor numbers, date and time of receipt)
      and the entry then signed.

  •   Blood must never be stored in the Ward fridge.




                                             33
Appendix 4


    The policy for the provision of O negative blood
                   for emergency use
  The Blood transfusion laboratory provides:
     • Two units of O negative blood for emergency use in the Accident and
        Emergency Department. (See Major haemorrhage policy)
     • Two units of O negative blood for emergency maternal use (See Major
        Obstetric haemorrhage protocol) and Two units of paediatric O negative
        blood for emergency neonatal use in the satellite blood fridge on the labour
        ward
     Please note that the Blood Transfusion laboratory also keeps 2 units of O
     negative blood for immediate use.

  The provision of these units of uncross-matched O negative blood for emergency
  use is to reduce any major morbidity or mortality that may be related to the delay in
  administration of blood products during a major haemorrhage, major obstetric
  haemorrhage and major neonatal haemorrhage.

  A sample for full cross-matching of further units and retrospective cross-match
  must be taken prior to commencing transfusion of uncross-matched emergency O
  negative blood or as soon as possible in the transfusion sequence and taken to
  blood bank. Where neonatal uncross-matched blood has been transfused, a
  maternal sample should also be taken, if not already sent during delivery.

     The Blood Bank laboratory staff will be responsible for ensuring that blood stored
     remains in date. The fridge will be checked daily and units will be replaced 7 days prior
     to their expiry date.
     If the blood is used the blood bank must be informed immediately so that the blood can
     be replaced
     When the blood has been used, please enter the patient’s name and hospital number
     onto the unit’s compatibility and traceability tag and return it to the blood bank
     The nurse or midwife allocated to the area where the blood fridge is will be responsible
     for daily check of uncross-matched O negative blood and informing blood bank if blood
     has been used and not replaced. Checking should be recorded on the Emergency
     blood log.
     Blood may not be returned to the blood fridge if it has been out of temperature control
     for 30 minutes or over. If blood has been removed from the blood fridge for 30 minutes
     or over, and not used it must be returned to blood bank to be destroyed and units
     replaced.

  The provision of O negative blood for emergency use is overseen by the Hospital
  Transfusion Committee.




                                            34
     Use of emergency O negative uncross-matched
              blood on the Labour ward.
   The Blood transfusion laboratory provides:
            Two units of O negative blood for emergency maternal use (See Major
            Obstetric haemorrhage protocol)
            Two units of paediatric O negative blood for emergency neonatal use
               A paediatric blood component administration line will be stored with
               paediatric units.
These units are kept in the satellite blood fridge on the labour ward. The labour ward
satellite blood fridge in located in the Close Maternal Observations Area (CLOMA).

The provision of these units of uncross-matched O negative blood for emergency use is to
reduce any major morbidity or mortality that may be related to the delay in administration of
blood products during a major maternal or neonatal haemorrhage.

A sample for full cross-matching of further units and retrospective cross-match must be
taken prior to commencing transfusion of uncross-matched emergency O negative
blood or as soon as possible in the transfusion sequence and taken to blood bank.
Where neonatal uncross-matched blood has been transfused, a maternal sample should
also be taken, if not already sent during delivery.

       The Blood Bank laboratory staff will be responsible for ensuring that blood stored
       remains in date. The fridge will be checked daily and units will be replaced 7 days prior
       to their expiry date.
       If the blood is used the blood bank must be informed immediately so that the blood can
       be replaced
       When the blood has been used, please enter the patient’s name and hospital number
       onto the unit’s compatibility and traceability tag and return it to the blood bank
       The midwife allocated to CLOMA will be responsible for daily check of uncross-matched
       O negative blood and informing blood bank if blood has been used and not replaced.
       Checking should be recorded on the Emergency blood log.
       Blood may not be returned to the blood fridge if it has been out of temperature control
       for 30 minutes or over. If blood has been removed from the blood fridge for 30 minutes
       or over, and not used it must be returned to blood bank to be destroyed and units
       replaced.

Please note that the paediatric units are not to be used for Exchange Transfusions
under any circumstances




                                              35
 Use of emergency O negative uncross-matched
blood in the Accident and Emergency Department

 The Blood transfusion laboratory provides two units of O negative blood for
 emergency use in the Accident and Emergency Department.

 These units are kept in the satellite blood fridge in the Treatment room in the
 Accident and Emergency Department.

 The provision of these units of uncross-matched O negative blood for emergency
 use is to reduce any major morbidity or mortality that may be related to the delay in
 administration of blood products during a major haemorrhage.

 A sample for full cross-matching of further units and retrospective cross-match
 must be taken prior to commencing transfusion of uncross-matched emergency O
 negative blood or as soon as possible in the transfusion sequence and taken to
 blood bank.

    The Blood Bank laboratory staff will be responsible for ensuring that blood stored
    remains in date. The fridge will be checked daily (Monday to Friday) and units will be
    replaced 7 days prior to their expiry date.
    If the blood is used the blood bank must be informed immediately so that the blood
    can be replaced
    When the blood has been used:
         o Enter the patient’s name and hospital and the data and time of transfusion into
            the emergency blood register
         o Enter the patient’s name and hospital number onto the unit’s compatibility and
            traceability tag and return it to the blood bank
    The nurse allocated to the Treatment room will be responsible for daily check of the
    uncross-matched O negative blood and informing Blood Bank if blood has been used
    and not replaced. Checking should be recorded on the Emergency blood checklist.
    Blood may not be returned to the blood fridge if it has been out of temperature
    control for 30 minutes or over. If blood has been removed from the blood fridge
    for 30 minutes or over and not used, it must be returned to blood bank to be
    destroyed and units replaced.




                                          36
Appendix 5

    Transfer of Blood Components with Patients between Hospitals
Introduction
Under the Blood Safety & Quality Regulations 2005 the Trust is:
    • Required to have unambiguous evidence of the fate of all blood components issued by
       the Blood Bank.
    • Required to ensure that blood products are stored, transported and distributed in the
       correct manner and that the correct storage temperature is maintained at all times. The
       correct storage of blood components is essential to ensure patient safety.
    •

Transferring blood components with a patient from the Royal Free
Hospital
If it is necessary to transfer a patient to another hospital the blood components allocated to the
patient can be transferred with them. The blood components may be required for urgent
resuscitation en route or on arrival at the receiving hospital. Blood components might also be
transferred if a patient has a rare blood group or multiple antibodies that could make cross-
matching suitable blood slow or difficult at the receiving hospital.

If blood or blood components are to be transferred with a patient:
        You must inform Blood bank for so that the correct documentation is obtained and the
        blood components are correctly packed in a validated NBS blood component transport
        box.
        Keep the transport box closed and only open if it necessary to remove components.
        The clinical staff escorting the patient must ensure that any unused blood components
        and documentation are handed over at the receiving hospital for transfer to the
        receiving hospital’s blood bank. Please note that the NBS transport box does not need
        to be brought back.
                    Blood must never leave the Royal Free Hospital
                          without informing the Blood Bank.

Receiving blood components with a patient at the Royal Free
Hospital
       If a patient is transferred to the Royal Free Hospital with blood components they must
       be taken to the Blood bank immediately in the transport box with their accompanying
       transfer documentation.
       Do not transfer the blood components to a satellite fridge
       If any blood components were transfused in transit, any accompanying documentation
       such as traceability tags must be sent to the Blood bank.
       If the blood components were not transferred in a transport box they must be deemed
       to be Out of Temperature Control and must not be used.
       Remember to urgently assign a Royal Free Hospital number to the patient and
       send an urgent sample and request for cross-match to the Blood Bank.

                 Blood components which have been inappropriately
                          stored are unsafe to transfuse.




                                               37
    Appendix 6

                                Blood Transfusion for Neonates

     All blood will now be filtered, using the “Baxter” blood filter giving set.

    The blood will be checked by two nurses, according to Hospital Guidelines.

    Equipment Required

    Sterile/clean field

    Gloves

    Blood transfusion set

    50 ml syringe (although the pumps can accept a 20ml syringe, they cannot not accept a 20ml
    syringe with the 3 way tap attached. This should stay connected during the transfusion)

    The small Graseby pumps should not be used to give blood)

    Saline flush

    Drawing up the blood

    The blood will be checked by two nurses, according to Hospital Guidelines

    The unit will be attached to the infusion set, and the syringe attached to the 3 way tap.

                                                                                   Syringe




                                                                                             Baby
Unit of blood



    The 3 way tap is turned on at the syringe port and blood is drawn into the syringe.
    This is the turned off at the 3 way tap and turned on the infusion line.
    Blood is then advanced along this tubing until the correct amount is available in the syringe.

    The trolley is then wheeled to the baby’s bedside and the syringe is attached to the pump.

    The line may be flushed to ensure that it is patent and the infusion line attached. (the unit of
    blood will be attached throughout the infusion)

    The rate is then checked by the two nurses and the procedure documented in the notes.

    Appropriate observation is carried out throughout the procedure.

    The entire infusion set will be discarded after use.



                                                      38
Appendix 7

Special Blood Product Requirements
Prevention of transfusion-associated graft-versus-host disease (TA-GvHD)
TA-GvHD occurs in severely immuno-suppressed patients, primarily those with congenital
immune deficiencies or haematologic malignancies who are receiving intensive chemotherapy.
It can also occur in immuno-competent transfusion recipients when the donor shares the same
HLA haplotype as the blood donor. Transfused donor lymphocytes which are compatible with
the recipient, but which recognise the recipient as foreign, can engraft and initiate TA-GvHD.
Patients develop skin rash, diarrhoea and abnormal liver function, and deteriorate, with bone
marrow failure and death from infection usually within two to three weeks of transfusion. TA-
GvHD can be prevented by gamma irradiating (25 Gy dose) the blood components to be
transfused. This inactivates the donor lymphocytes. Leucocyte depletion cannot be considered
to remove risk of TA-GvHD.
Clinical indications for irradiation as on the special requirements form are shown below:

                                  Irradiated Blood Products
Ordering Special Blood Products Requirements
To order irradiated and / or CMV negative products you must use the Blood Transfusion
Laboratory Special Blood Products Requirements form. This form is available on 4WB and 4S
and 12EB. There is also an Electronic form which can be found on FreeNet on the Blood
Transfusion Laboratory site. You can also download and print out a copy of the form from
there.
Information leaflet for patients who need irradiated blood components
The National Blood Service produces an information leaflet called “Information for patients
needing irradiated blood”. Within the leaflet is a sticker which must be attached to the patient’s
notes and a card for the patient to carry at all times. The card should be completed by a
member of staff. The card is an extra safeguard in case the patient’s records are not available
or the patient is being treated at another hospital. The patient should show the card to the
doctor if a transfusion is required. Copies of the information leaflet can be obtained either from
Specialist Practitioner of Transfusion (ext 35875)

Indications:
□ BMT/PBSCT: all autologous and allogeneic recipients from 1 month pre-transplant.
□ All SCT donors (auto, sibling, unrelated) for 1 month prior to BM/PBSC collection.
□ All patient’s with Hodgkin’s disease (indefinitely).
□ Patient’s receiving or who have ever received Purine Analogues: Fludarabine,
Deoxycoformycin (DCF), 2-chlorodeoxyadenesine (2CDA).
□ Aplastic anaemia on ALG/ATG.
□ Congenital immune deficiency syndromes.
□ Premature infants below the weight of 1200g.
□ Intrauterine transfusions (IUT) and for 1 year post IUT.
□ Donations from first degree relatives.
□ Buffy coats / granulocyte transfusion.
□ Consider in B-cell Non-Hodgkin’s Lymphoma (Discuss with consultant).
Source: Handbook of Transfusion Medicine 4th Edition. Editor D B L McClelland. TSO, London. 2007




                                                     39
Prevention of cytomegalovirus transmission
Cytomegalovirus (CMV) infection can cause serious morbidity in immuno-compromised CMV-
negative patients. The risk can be minimised by the use of CMV-antibody-negative (sero-
negative) blood components. Leucocyte depletion also confers some protection since the virus
is associated with white blood cells. A consensus conference in 2001 concluded that
components that are both CMV-sero-negative and leucodepleted should be used for CMV-
sero-negative pregnant women, intrauterine transfusions, and CMV-sero-negative-allogeneic
stem cell transplant recipients. Some studies, however, suggest that effective leucodepletion
may confer as much protection as the use of CMV-negative components.
Clinical indications for CMV negative products as on the special requirements form are shown
below:
                                    CMV negative products

Main indications
□ CMV negative BMT/PBSCT recipients / potential recipients or until        CMV status known.
□ All pregnant women except at delivery.
□ Intrauterine and neonatal transfusion.
□ Other
Other. Please specify:________________________________________________

Source: Handbook of Transfusion Medicine 4th Edition. Editor D B L McClelland. TSO, London. 2007



Ordering Special Blood Products Requirements
Requests for special requirements should be made by a haematology specialist registrar (SpR)
or haematology consultant only. Out-of-hours the requests can be submitted by junior medical
staff but must be first discussed by the haematology SpR or consultant on call.
To order irradiated and / or CMV negative products you must use the Blood Transfusion
Laboratory Special Blood Products Requirements form. This form is available on 4WB, 4S and
12EB. There is also an Electronic form which can be found on FreeNet on the Blood
Transfusion Laboratory site. You can also download and print out a copy of the form from
there.
.

Patient education and documentation
The request for special requirements must be documented in the patient’s notes at the time of
the request. The requesting doctor must provide the patient with information on their need for
irradiated blood components. The Trust uses the NHSBT patient information leaflet
“Information for patients needing irradiated blood” which contains a patient card and patient
record stickers. It is the requesting doctor’s responsibility to fill-in the patient information card
and give it to the patient and also ensure that the sticker is put on the patient’s case notes. The
patient must be informed of the need to carry the card at all times and to present it to clinical
staff when necessary particularly if the patient is being treated at another hospital. If the patient
needs a new set of notes a new sticker must be placed on them. The sticker, patient card and
patient information leaflets are available on 4 South, 4 West B, 12 East B, BMT Clinic, Clinic 6
(CLL clinic) and Clinic 3 (lymphoma clinic). If you require a supply of leaflets please contact the
transfusion practitioners ext.35875. The patient information leaflet is available for download in
Albanian, Arabic, Bengali, Chinese, Croatian, Farsi, French, Greek,




                                                     40
Appendix 8
                  THE ROYAL FREE HAMPSTEAD NHS TRUST
          INVESTIGATION OF ACUTE TRANSFUSION REACTIONS FORM
                                      REQUESTING DOCTOR_______________________
                                      BLEEP________
                                      WARD________________________
          Patient label
                                      HOSPITAL_____________________
                                      DATE__________________________
                                      TIME__________________________ (24 hr clock)
If a transfusion reaction is thought serious enough to investigate, it should be
investigated fully and immediately. It is not necessary to investigate simple febrile or
urticarial reactions.
         CONTACT THE TRANSFUSION LABORATORY IN THE FIRST INSTANCE.
Stop the transfusion and change the giving set. Return the suspected unit with its
giving set and all the previously used blood component bags for the patient to the
transfusion laboratory. Return this form with the suspected unit.
Interval between commencement of transfusion of the unit and the time reaction first noted:
[ ] <15 mins.    [ ] < 1 hour   [ ] 1-3 hour      [ ] After completion

Type of component: [ ] Red cells [ ] Platelets        [ ] FFP       [ ] Cryoprecipitate

Patients Symptoms (Please tick as appropriate)
 Pyrexia [ ]                Anxiety [ ]                Productive cough [ ]
 Chills or rigor [ ]        Loin pain [ ]              Pink frothy sputum [ ]
 Nausea/vomiting [ ]        Hives/urticaria [ ]        Pain at infusion site [ ]
 Headache [ ]               Short of breath [ ]        Haemoglobinuria [ ]
 Tachycardia [ ]            Wheeze [ ]
 Back pain [ ]              Hypotension [ ]

Patient’s diagnosis




Medical condition of patient
 Septicaemic [ ]           Ventilated in ITU [ ]       Hickman/Central line in situ [ ]
 Previous transfusion reactions [ ]

Reason for Transfusion




Essential samples are:
 G&S x 2 [ ]                 U & Es with liver function tests [ ]          FBC [ ]
 Clotting screen [ ]         First urine passed [ ]
 Blood cultures ( if bacterial contamination suspected) [ ]

                                                41
42
Appendix 9


Blood transfusion laboratory website on FreeNet
The blood transfusion laboratory provides blood components for transfusion at the
Royal Free and RNTNE hospitals. The aim of these web pages is to provide information
on how to order blood components correctly and to give easy access to the standard
blood order schedule. There is also information on issues such as variant Creutzfeldt-
Jakob disease and the serious hazards of transfusion (SHOT) report as well as
information on what is happening at the Royal Free. There are links to sites of interest
and a list of books, journals and journal references on transfusion and related subjects.

Samples, request forms and timing of transfusion
Standard blood order schedule
Out of hours access
Transfusion thresholds
Useful contacts
Variant Creutzfeldt-Jakob disease
Anti-D Prophylaxis
Protocols, handbooks and guidelines
Serious hazards of transfusion report
Royal Free Hospital transfusion committee
Blood safety and quality regulations
Books and journals
Links to sites of interest
Patient information
Special blood product requirements (e-form)




                                           43
Appendix 10


                      The Royal Free Hampstead NHS Trust
                            Transfusion Committee
                              Terms of Reference

Frequency of meetings: Every three months

Membership:
          Chair- Medical director
          Members of the Hospital Transfusion Team
                  Consultant in Transfusion Medicine
                  Service Manager Blood Transfusion
                  Chief BMS Transfusion Laboratory
                  Specialist Practitioners of Transfusion
                  Quality Manager Transfusion and Haematology
          General Manager, Pathology Directorate
          Clinical Director, Pathology Directorate
          General Manager or Clinical Director or nominated representative Cancer and
          Clinical Haematology
          General Manager or Clinical Director or nominated representative Hepatology,
          Nephrology and Transplantation
          General Manager or Clinical Director or nominated representative Medicine
          Directorate
          General Manager or Clinical Director or nominated representative Neurosciences
          Directorate
          General Manager or Clinical Director or nominated representative RNTNE, ENT,
          audiology and ophthalmology Directorate
          General Manager or Clinical Director or nominated representative Surgery,
          Anaesthetics and Critical Care Directorate
          General Manager or Clinical Director or nominated representative Women and
          Children’s services Directorate
          Practice Development Nurse, Nursing Directorate
          Midwifery representative.
          Risk Manager
          Nominated representative Clinical Service Improvement Directorate
   Other members can be co-opted as required e.g. representatives of high volume users.

Function of Committee
The Hospital Transfusion Committee will:
      Promote best transfusion practice throughout the Trust through the development of
      Trust protocols and guideline based on national guidelines.
      Lead multi-professional audit of the use of blood components within the Trust.
      Promote the appropriate use of blood components.
      Promote the education and training of all clinical, laboratory and support staff involved
      in blood transfusion.
      Manage the Trust’s contingency planning for the shortage of blood components.
      Consult with local patient representative groups where appropriate.
      The Hospital Transfusion Committee reports to the Clinical Risk Committee and the
      Hospital Transfusion Team will produce an annual report for that committee.




                                              44
Standing Items on the Hospital Transfusion Committee Agenda
     Financial report
     Report on trust performance for blood component traceability
     Report on trust performance for Mandatory transfusion training and competency
     assessment of all staff
     Review of the use of emergency O negative blood in the Emergency Department and
     the Labour ward
     Review of clinical incidents – to include all severe incidents and reactions reported to
     the MHRA.




                                             45
                                                           Equality Impact Assessment Matrix

 Name of policy/service                                         Transfusion of blood components policy

 Name of Manager responsible for completing impact              David Mold, Transfusion Practitioner
 assessment
 Is this a new policy/service or a review of an existing        Review of existing policy
 policy/service?
 What is the purpose of the policy/service?                     To inform hospital staff of the correct method of prescribing, ordering,
                                                                storing, administering a blood or blood component transfusion and disposing
                                                                of empty component bags and used giving sets.
 Who is intended to benefit from the policy and in what         The policy is for the benefit of all patients that require the transfusion of a
 way?                                                           blood component

 Date commenced                                  31/1/08        Date completed
 Policy/service review date                      31/1/09

Using the matrix below, review the policy/service under consideration, in relation to the six equality strands, for differential impact upon
service users or trust staff and identify what these might be:

 Group (highlight                  Age         Race/ethnicity          Gender           Disability        Religion/belief    Sexual orientation
 relevant groups)
 1. Is there any              No          No                      No               No                  Yes. Jehovah’s       No
     evidence that                                                                                     Witnesses refuse
     groups have                                                                                       the transfusion of
     different needs,                                                                                  blood components
     experiences or
     priorities in relation
     to this policy and if
     so, what?




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                               Age            Race/ethnicity             Gender              Disability         Religion/belief       Sexual orientation
2. Is the any             No                No                      No                  No                    The refusal of          No
   evidence/ concern                                                                                          Jehovah’s
   that this proposal                                                                                         Witnesses to receive
   could result in a                                                                                          the transfusion of
   qualitative or                                                                                             blood components
   quantitative                                                                                               necessitates the
   differences in                                                                                             provision of a
   impact on any                                                                                              separate policy for
   group and if so                                                                                            the management of
   what?                                                                                                      this group of
                                                                                                              patients



3. Does the proposal      Yes. Policy       Yes. Policy             Yes. Policy         Yes. Policy           Yes. Policy provides    Yes. Policy
   promote equality of    provides          provides staff with     provides staff      provides staff with   staff with the          provides staff with
   opportunity/           staff with the    the knowledge to        with the            the knowledge to      knowledge to give       the knowledge to
   access/good            knowledge         give all patients       knowledge to        give all patients     all patients with       give all patients
   relations within the   to give all       with optimal care in    give all patients   with optimal care     optimal care in         with optimal care in
   organisation and       patients with     relation to             with optimal care   in relation to        relation to             relation to
   the wider              optimal care      transfusion.            in relation to      transfusion.          transfusion. There      transfusion.
   community and          in relation to                            transfusion.                              are clear guidelines
   how is this            transfusion.                                                                        in the policy for the
   evidenced?                                                                                                 management of
                                                                                                              patients who refuse
                                                                                                              blood transfusion



4. Who are the key        Policy            Policy circulated       Policy circulated   Policy circulated     Policy circulated for   Policy circulated for
   stakeholders in        circulated        for comment to all      for comment to      for comment to all    comment to all          comment to all
   relation to this       for comment       clinical directorates   all clinical        clinical              clinical directorates   clinical directorates
   policy and how are     to all clinical   and clinical            directorates and    directorates and      and clinical practice   and clinical practice
   they being             directorates      practice group          clinical practice   clinical practice     group                   group
   consulted?             and clinical                              group               group
                          practice
                          group




                                                                              47
                              Age    Race/ethnicity        Gender        Disability    Religion/belief   Sexual orientation
5. Are there any         No         No                No            No                No                 No
   concerns that the
   policy/service
   development could
   have a differential
   impact on any
   group(s) and how
   might this be
   evidenced?
6. Do you anticipate     No         No                No            No                No                 No
   any areas where
   there may be
   inconsistencies in
   application and are
   there alternative
   arrangements that
   could
   reduce/eliminate
   impact?




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Using the information from the matrix complete the following action plan:

 Area of concern         Groups likely to           Action planned to         Monitoring                Review date
                         experience differential    minimise                  arrangements
                                                    discrimination/promote
                                                    equality of access
 1. Religion/Belief      Jehovah’s Witnesses        The Trust has a policy    All patients refusing     March 2012
                                                    for the management of     transfusion must be
                                                    patients who refuse       referred to the
                                                    transfusion and also      Transfusion consultant
                                                    runs a Blood              and seen in the blood
                                                    Conservation Clinic       conservation clinic
                                                    where all of these
                                                    patients are seen


 Name of manager completing assessment                           David Mold. Transfusion Practitioner


 Date assessment sent to Equality and Diversity Manager          27/2/08


 Name of Equality and Diversity Manager                          Jennifer Kenward


 Date of publication of Impact assessment                        27/02/08




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