Blood Transfusion Policy adverse reaction by benbenzhou

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									                                      Blood Transfusion Policy




Reference Number                                       3.18

Version                                                6
Name of responsible (ratifying)
                                                       Hospital Transfusion Committee
committee
Date ratified                                          December 2009

Document Manager (job title)                           Transfusion Practitioner

Date issued                                            12.03.2010

Review date                                            December 2012

Electronic location                                    Corporate Policies
                                                       Patient Identity Policy; Management of Adverse
Related Procedural Documents                           Incidents and Near Misses; Management of Serious
                                                       Untoward Incidents
                                                       Blood Platelets; Red Cells; Transfusion Reactions;
                                                       Administration; Observations; Blood products;
                                                       Administration sets; Plasma; Blood transfusion;
                                                       Blood products; Clinical procedures; Adults;
                                                       Children; Neonates; Patients; Medical records;
                                                       Health professionals; Unconsciousness;
Key Words (to aid with searching)
                                                       Identification systems; Prescriptions; Blood banks;
                                                       Infusions; Blood warmers; Blood transfusion
                                                       equipment; Patient safety; Clinical protocols;
                                                       Jehovah witnesses; Religious beliefs; Training;
                                                       Blood letting; Adverse medical reactions; Neonates;
                                                       Transport; Clinical guidelines
In the case of hard copies of this policy the content can only be assured to be accurate on the date of issue marked
on the document.

For assurance that the most up to date policy is being used, staff should refer to the version held on the intranet


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CONTENTS

     QUICK REFERENCE GUIDE ...........................................................................................3
1.   INTRODUCTION..............................................................................................................4
2.   PURPOSE .......................................................................................................................4
3.   SCOPE............................................................................................................................4
4.   DEFINITIONS ..................................................................................................................4
5.   DUTIES AND RESPONSIBILITIES ...................................................................................5
6.   PROCESS .......................................................................................................................7
7.   TRAINING REQUIREMENTS……………………………………………………………………...13
8.   REFERENCES AND ASSOCIATED DOCUMENTATION ................................................ 14
9.   MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF, PROCEDURAL
     DOCUMENTS................................................................................................................ 14




APPENDICES:
     1.   Flowchart for the Management of an adverse Transfusion reaction in Adults
     2.   Flowchart for the Management of an adverse Transfusion reaction in Neonates/Children
     3.   Administration: Neonates and older children
     4.   Clinical indication for the administration of blood and blood products - Neonates only
     5.   Transport of blood and blood components (SOP 305)




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QUICK REFERENCE GUIDE

For quick reference the guide below is a summary of actions required. This does not negate the need
for the document author and others involved in the process to be aware of and follow the detail of this
policy.


   1. Obtaining consent for a blood transfusion is a Department of Health requirement and is the
      responsibility of the doctor prescribing the blood products. Do not forget the rights of the
      patient to refuse a transfusion/opt for a different treatment, if available.

   2. Only registered medical practitioners can request blood products and request forms must
      contain the four markers of patient identity: surname; given name; date of birth and NHS
      number

   3. Only suitably trained medical, nursing or phlebotomy staff may take samples for cross-
      matching

   4. All staff collecting blood products must have annual update training and must have their
      badges validated

   5. When collecting blood products staff must check the patient‟s identification against the blood
      product compatibility label

   6. A patient‟s identification must be checked against the blood product compatibility label before
      the transfusion is commenced.

   7. Transfusions must be given in clinical areas, where frequent visual and verbal contact may be
      made

   8. The patient‟s temperature; pulse; respiratory rate; and blood pressure must be checked at the
      beginning of the transfusion and 15 minutes thereafter, as this is the most likely time frame for
      an adverse reaction to occur

   9. Patient‟s must be told to inform a member of staff if, any time during the transfusion, they feel
      unwell

   10. The patient‟s observations must be repeated at the end of the transfusion

   11. Transfusions at night should be avoided unless absolutely necessary

   12. The same giving set used for the transfusion must not be subsequently used for administering
       fluids

   13. Blood must not be stored in a ward / drug fridge

   14. Accurate documentation of the transfusion and any adverse reaction(s) must be maintained




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 1. INTRODUCTION

      Appropriate blood transfusion is an essential support to many medical treatments and is
      lifesaving. Problems with the safety of blood transfusion are highlighted through the Serious
      Hazards of Transfusion (SHOT) scheme. This scheme has shown that avoidable, serious
      hazards of blood transfusion continue to occur in Trusts, the most common being giving the
      wrong blood to patients. There are many risks to the patient and these include acute haemolytic
      reactions and transfusion transmitted infections. Blood transfusion has been associated with
      poor outcomes in a dose-dependent manner in trauma patients, after major surgery and in an
      intensive care unit. Stringent procedures must be followed to ensure that the correct blood is
      always given and that any adverse reactions are dealt with promptly and efficiently

      Procedures for ordering, prescribing and administration of blood components, as well as the
      management of any complications support this clinical policy on blood transfusion. Procedures
      for the documentation of transfusions in nursing, medical and laboratory records are also
      provided, including the procedure for the reporting of any adverse reactions or events occurring
      in relation to transfusions

      This clinical policy has been revised to clarify terminology, incorporates core standards in
      transfusion practice in adults, in neonatal and pediatric practice. Neonatal Intensive Care
      patients are one of the most transfused groups; because of their potential normal life
      expectancy they are more susceptible to the long-term effects of transfusion. Particular care
      and attention must be given to neonates and children to minimise blood product use

      This policy also reflects changes to legislation brought in 2005 by the European Directive
      2002/98 EC as enacted by HM Government in the Blood Safety and Quality Regulations (50)
      2005.

 2. PURPOSE

      The purpose of this policy is to:

              Provide a clear framework and guidance for safe transfusion practice, throughout
               Portsmouth Hospitals NHS Trust (the Trust)
              Ensure a consistent approach to the prescribing, handling and administration of blood
               and blood components throughout the Trust
              Ensure that all members of staff involved in any stage of the process of transfusing
               blood and blood products are aware of their role and the legal aspects of this practice

 3. SCOPE
      This policy applies to all staff involved in the requesting, sampling, prescribing, storing,
      collecting, transporting and administering of human blood and blood components, including
      those who work in Primary Care Trusts supplied with blood products / blood components from
      the Trust blood banks.

     ‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises
     that it may not be possible to adhere to all aspects of this document. In such circumstances,
     staff should take advice from their manager and all possible action must be taken to
     maintain ongoing patient and staff safety’

 4. DEFINITIONS

      Transfusion: whole blood or any of its components used to correct or treat a clinical
      abnormality


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      Blood components: red cells, fresh frozen plasma (FFP), cryoprecipitate, and platelet
      concentrates

      Blood Products: any drug which is manufactured using human blood components

      Cold chain: the legal requirements to monitor transport and storage conditions of blood, from
      donor to recipient

      iPassport: the Blood Sciences electronic quality management system onto which all
      documents, audits and self-inspections are registered

      Maximum Blood Ordering Schedule (MBOS): the Trust agreed maximum number of cross-
      matched units or group and screen testing requirements for surgical procedures

      Medicines and Healthcare Regulatory Agency (MHRA): An executive agency which aims to
      enhance and safeguard the health of the public by ensuring that medicines and medical
      devices work and are acceptably safe

      National Patient Safety Agency (NPSA): An arm‟s length body of the Department of Health
      which leads and contributes to improved, safe patient care by informing, supporting and
      influencing organisations and people working in the health sector

      SABRE – Serious Adverse Blood Reactions & Events (SABRE): the MHRA reporting scheme
      to which all adverse events related to blood component / products are reprted

      Serious Hazards of Transfusion reporting system (SHOT): the United Kingdom‟s
      independent, professionally-led haemovigilance scheme; responsible for recording and
      monitoring all blood component/product adverse events

 5. DUTIES AND RESPONSIBILITIES

      Chief Executive
      The Chief Executive has overall responsibility for ensuring that the Trust complies with relevant
      Legal and Statutory Requirements surrounding Blood Transfusion Practice but delegates this
      responsibility to the Hospital Transfusion Committee

     Governance and Quality Committee is responsible for:
       Receiving an annual report from the Hospital Transfusion Committee, as per the
         Governance and Quality Committee reporting schedule
       Recommending any action as they see fit to ensure the safety of transfusion in the Trust

     Risk Assurance Committee (RAC)
     The purpose of the Risk Assurance Committee is to promote effective risk management and to
     establish and maintain an assurance framework and a risk register through which the Board
     can monitor the arrangements in place to achieve a satisfactory level of internal control, safety
     and quality.

     Serious Incident Review Group
     The Group is responsible for receiving and agreeing reports from the Hospital Transfusion
     Committee with regard to any investigation into serious untoward incidents; prior to submission
     of those reports to our Commissioners

      The Hospital Transfusion Committee
      The Committee is comprised of members of the Hospital Transfusion Team and
      representatives from all clinical areas were a blood component/product is administered. It has
      responsibility for


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                   Overseeing all aspects of blood transfusion practice
                   Promoting good transfusion practice based on national guidelines through the
                    provision of a robust framework to communicate information and advice
                   Arranging for audits of blood usage to be carried out, in line with local and national
                    requirements and receiving and reviewing the reports of those audits
                   Making recommendations to address any issues highlighted by the reports and
                    monitoring the implementation of the actions to prevent a recurrence
                   Receiving quarterly reports from the Hospital Transfusion Team regarding the
                    trends/themes from adverse incidents, including any variance from this policy and for
                    recommending any actions to address the variance
                   Reviewing all SHOT submissions and ensure the root causes are identified and all
                    necessary action taken to prevent a recurrence
                   Monitoring the implementation of actions arising from the investigations 1 of Serious
                    Untoward Incidents2
                   Receiving the results of all audits associated with the transfusion process and
                    developing any required action plans to address the identified issues
                   Undertaking regular review of this policy and recommending any changes as
                    highlighted by audits or adverse incidents
                   Ensuring any risks associated with the transfusion process are assessed and
                    escalated to the Trust Risk Register
                   Acting as a forum to discuss advancements in transfusion practice and reviewing and
                    amending practices and policies in the light of those advancements
                   Providing, through the Chair, an annual report on all aspects of blood transfusion
                    practice, to the Governance and Quality Committee

      Hospital Transfusion Team
      The Team, which comprises the Blood Bank Manager, Clinical Lead for Blood Transfusion and
      the Hospital Transfusion Practitioner is responsible for:

                   Meeting weekly to discuss current issues and incidents
                   Addressing and monitoring any outstanding corrective and preventative actions
                   Informing the decision-making process for new initiatives
                   Ensuring the Hospital Transfusion Committee is informed of any required audits
                   Reporting quarterly to the Hospital Transfusion Committee
                   The review and development of policies and guidelines

      Hospital Transfusion Practitioner
      The Practitioner is responsible for

                   The investigation of all adverse incidents / near misses associated with any aspect of
                    blood transfusion, in conjunction with the Blood Bank Manager
                   Submission of reports to SHOT/SABRE, in conjunction with the Blood Bank Manager
                   Providing the Hospital Transfusion Committee with quarterly reports on all aspects of
                    transfusion practice, including adverse events
                   Facilitating training for all relevant staff groups
                   Acting as the main point of contact for staff requiring information / guidance.

      Blood Bank Manager
      The Blood Bank Manager is responsible for:
           Ensuring the laboratory complies with the legislation as set down in the Blood and
              Safety Quality Regulations 2005 and the statutory requirements of the Department of
              Health to ensure patient and staff safety


      1
          Policy for the Investigation of Incidents, Complaints and Claims
      2
          Policy for the Management of Serious Untoward Incidents
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                  The investigation of all adverse incidents / near misses associated with any aspect of
                   blood transfusion, in conjunction with the Hospital Transfusion Practitioner
                  Submission of reports to SHOT/SABRE, in conjunction with the Hospital Transfusion
                   Practitioner

     Blood Sciences Quality Manager
     The Quality Manger is responsible for the quality management system: IPassport

      All Ward/Line Managers
      All managers have a responsibility:

                  To be aware of this policy and associated guidelines
                  Releasing staff for training
                  Integrating compliance into the Knowledge and Skills Framework and appraisals for all
                   staff
                  Ensuring appropriate evidence of compliance is gained during the appraisal process
                  Ensure their staff are aware of this policy and comply with its content

      All staff involved in the processes associated with blood transfusion
      All staff have a responsibility to:

            Attend training relevant to their role in the process
            Comply with this policy at a level commensurate with their involvement
            Report all adverse incidents and near misses


 6. PROCESS
      Note: whilst the same principles apply to all patients, regardless of age, there are some very
      specific issues which related to neonates: Appendices 3 and 4

     6.1       Consent
               6.1.1 Obtaining consent for a blood transfusion is a Department of Health requirement
                     and it is the responsibility of the doctor prescribing the blood product(s) to obtain
                     and document that consent, in accordance with Trust Policy3. If the patient is
                     unable to provide consent, this must also be documented

               6.1.2 Where practical, patients should be informed of the reasons for the blood
                     transfusion, the potential risks and benefits involved. They should also be informed
                     of their right to refuse the transfusion but must then be advised of the risks of
                     doing so.

               6.1.3 All staff, but particularly those taking consent must be aware:

                              Of the beliefs of the Jehovah‟s Witness in relation to receiving any blood
                               component and medical alternatives, which may be applicable.
                              That any patient may have valid personal reasons or beliefs for not wishing
                               to have a transfusion
                              That each patient has the right to be treated with respect and staff must be
                               sensitive to their individual needs, acknowledging their values, beliefs and
                               cultural background
                              That an individual patient may accept different treatments such as dialysis,
                               cardiopulmonary bypass, organ transplants, and non-blood replacement
                               fluids of plasma derivatives



      3
          Consent Policy
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                        For guidance regarding religious or personal beliefs please see the Trust Refusal
                        of Blood Components Guideline and the Trust‟s Transfusion Guidelines

              6.1.3 The patient should be provided with information about alternatives to blood
                    transfusion, including autologous transfusion, where appropriate

              6.1.4 As well as providing this information verbally, it is best practice to provide the
                    patient with the information leaflets, available on all wards or from the Blood
                    Sciences Department or National Blood Service

              6.1.5 In circumstances where a patient lacks the capacity to consent and it is an
                    emergency or urgent situation, treatment can be provide on the basis of „best
                    interests‟. However, in elective situations the healthcare professional seeking
                    consent must consider whether the patient has put in place either a valid and
                    applicable advanced decision or a Lasting Power of Attorney, which cover the
                    refusal of a blood transfusion. Further guidance can be obtained from the Trust‟s
                    Legal Services Manager

     6.2      Sampling Blood
              6.2.1 Only suitably trained and competent medical, nursing or phlebotomy staff may take
                    blood samples for cross-matching

              6.2.2 All blood must be taken in accordance with Trust policy 4

              6.2.3 The sample must be taken into a purple-capped EDTA (anticoagulated) tube and
                    immediately labeled at the bedside by the person who took the sample. The label
                    must contain the 4 identity markers: surname; given name; date of birth; NHS
                    number (or ED number if in the Emergency Department); hospital number together
                    with the name of the ward if an inpatient, as per Trust policy 5 and be signed and
                    include the date and time taken

              6.2.4 Pre-labeled tubes and addressographs must not be used

     6.3      Requesting Blood
              6.3.1 Only registered medical practitioners can make requests for blood and blood
                    components

              6.3.2 Request forms must contain the 4 identity markers as per Trust policy

              6.3.3 Requests for blood will not be processed if the sample is not appropriately labeled
                    and the requestor notified

              6.3.4 Unidentified/unconscious patients invariably occur in the ED. In these
                    circumstances a request form must contain: the patient‟s identity status, gender,
                    approximate age and the ED number. For example

              6.3.5 For patients who cannot supply the relevant information, the name and date of
                    birth can be verified by the patient‟s family, carer, guardian or other representative

      6.4 Requesting Special Blood Components/Products
          6.4.1 Requests for special blood products/components e.g. platelets and F.F.P. must be
                made by direct personal or telephone contact with a member of the laboratory staff
                (7700 6539)


      4
          Phlebotomy and Venous Blood Sampling Policy
      5
          Patient Identification Policy
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           6.4.2 As these products are often used in emergency situations this needs to be
                 highlighted to staff in blood bank as a priority

           6.4.3 Any verbal request must be followed up by written confirmation; to ensure accurate
                 recording and audit

           6.4.4 Patients who are for an elective procedure must have a blood antibody screen
                 performed more than 24 hours before the surgery

           6.4.5 The laboratory requires 24 hours notice to prepare red cells products for elective
                 procedures: to ensure availability

           6.4.6 Where antibodies are identified, selection of blood may take longer as difficult
                 cross-matches may require referral to Bristol

           6.4.7 Routine group and screen samples will not be processed out side of normal
                 working hour and it is not possible to make cross-matched blood components
                 available overnight for early morning theatre cases

           6.4.8 Routine surgery should not be cancelled because of non-availability of a group and
                  antibody screen: the most appropriate units will be made available in the event of
                  an emergency
     6.5   Collection
           6.5.1 It is a statutory obligation that all staff collecting blood/blood products must have
                  annual update training

           6.5.2 Before collecting blood products/components from the blood bank, staff must
                 check that a prescription has been correctly and full completed. To ensure that all
                 products are properly requested and prescribed and that the patient details are
                 correct, the prescription must include:

                        Completed patient identifiers
                        The type of blood component to be transfused, plus any special
                         requirements (e.g. CMV negative)
                        The quantity to be given
                        The duration or rate of infusion
                        Time to be given

           6.5.3 Only suitably trained, competent and validated staff can collect products. The
                 member of staff should:

                        Take written confirmation of the patient‟s identity to the Blood Bank
                         collection point. This can be achieved using one of the patient stickers from
                         their of health records: these stickers contain the required four points of
                         identity.
                        Swipe their validated ID card to gain access to the blood bank. Note: it is a
                          disciplinary offence to use someone else’s card
                        Select the unit(s) required and confirm the details on the
                         component/product compatibility label with the written confirmation of the
                         patient‟s identity
                        Use the MediTrack system to scan the bar codes of the unit(s) removed
                          Note: Scanning instructions for are on the Blood Bank door and on the MediTrack
                          screen
                        Take the unit(s) directly to the area in which it is needed and make no
                         diversions. Blood must not be stored in a ward fridge



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                      Only one unit should be removed at a time, other than in exceptional
                       circumstances, when an insulated box should be requested: this can store
                       blood for up to one hour, after which it should be returned to the Blood Bank

           6.5.4 On occasions porters will be asked to                     collect    and        deliver   blood
                 products/components. In these circumstances

                     When the products/components are available for collection, the blood bank
                      staff will call the Helpdesk and ask for a „Task Sheet‟ to be raised. This sheet
                      contains all the patient identifiers, clinical area and product/component to be
                      delivered
                     Staff who receive the blood product/component must sign the Task Sheet, to
                      provide an audit trail

     6.6 Process for administering blood products/components
         Note: for the administration and clinical indication of blood to neonates, please see
         Appendix 3 and 4
         6.6.1 Transfusions must be given in clinical areas, where frequent visual and verbal
                contact can be maintained

           6.6.2 Blood components can be administered peripherally or centrally.

           6.6.3 Nothing must be added to blood bags, under any circumstances

           6.6.4 The correct giving set must be used for the appropriate blood component/product
                 and its availability must be confirmed prior to collecting blood from the Blood Bank.

                            Type of Product                         Type of set
                               Red Cells                 Blood giving set with integral filter
                                Platelets                Blood giving set with integral filter
                       Fresh Frozen Plasma (FFP)          Fluid giving set: no need to filter
                                Albumin                   Fluid giving set: no need to filter

           6.6.5 Preparation of the appropriate giving set will prevent any unnecessary delay in
                 starting the transfusion

                      Packed Red Cells: should be started within 30 minutes of removal from blood
                       bank and administered over 2 – 4 hours. Two hours is ideal, as slow infusion
                       encourages bacterial growth in the unit. However, those patients with
                       underlying cardiac or respiratory conditions may require the transfusion to be
                       given over a longer period of time; to prevent overload
                      Platelets: start immediately received into area and administer over 30 minutes
                      FFP: start immediately received into area and administer stat

           6.6.6 The same giving set that is used for the transfusion must not subsequently used to
                 administer fluids

           6.6.7 A „Y connector must not be used, when using a peripheral cannula as this offers to
                 great a potential for infection

           6.6.8 Volumetric pumps can be used with the appropriate administration set

           6.6.9 No other fluids must be administered at the same time into the same peripheral
                 cannula. However, if a patient has a double lumen central/PICC line with distal and
                 proximal ports, separate fluids can be administered

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           6.6.10 The patient‟s identity must be confirmed on their ID band and this must be
                  checked with the information on the component/product compatibility label and the
                  patient‟s prescription chart. This must be done at the patient‟s bedside

           6.6.11 If the patient is conscious, they must also be asked to state their first name,
                  surname and date of birth

           6.6.12 If the patient is unconscious, or for some other reason cannot communicate
                  another member of staff or relative/carer can confirm the patient‟s identity

           6.6.13 In the event of an „unknown‟ patient, the ID band, which will include gender
                  (unknown male/female), emergency number and approximate age should be used
                  for checking purposes

           6.6.14 The member of staff must check the patient‟s identity again and check the expiry
                  date and time of the blood component/product, before setting up the transfusion. In
                  the case of any discrepancies, the transfusion must not be commenced:
                  handwritten amendments are not permitted

           6.6.15 The Transfusion

                   Conscious patients
                      Record the patient‟s temperature, pulse, respirations and blood pressure
                      Ask the patient to report if they are feeling unwell in any way
                      Record the patient‟s temperature, pulse, respirations and blood pressure
                       within 15 minutes: this is the crucial time, as severe reactions most frequently
                       occur within the first 15 minutes
                      Keep an eye on the patient regularly throughout the transfusion.
                      The recording of further observations and the regularity of those recordings is
                       at the discretion of the clinical area and is dependent on the clinical stability /
                       condition of the patient. Very often the recording of further observations is
                       only necessary if the patient becomes unwell.
                      At the end of the transfusion, repeat and record the patient‟s temperature,
                       pulse, respirations and blood pressure

                   Unconscious patients

                      Record the patient‟s temperature, pulse, respirations and blood pressure
                      Repeat the observations every 15 minutes for the first hour and hourly
                       thereafter
                      Visual observations of skin condition, cannula site and urine output must also
                       be undertaken regularly; and recorded

     6.7 Transfusing at Night
         6.7.1 Transfusions should not be given at night – between 22:00 and 08:00 – unless the
                patient is actively bleeding or has some other urgent clinical need, as deemed by
                the doctor caring for the patient


           6.7.2 Patients who are asymptomatic e.g. from their anaemia, will benefit more from
                 undisturbed sleep.

     6.8   Management of Adverse Reactions
           6.8.1 Careful observation of the patient is needed in case any signs or symptoms of an
                 adverse reaction occur, particularly during the first 15 minutes of the transfusion


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                   commencing. Patients with a severe reaction can deteriorate very quickly with
                   hypotension, respiratory distress, collapse and possible death.

           6.8.2 Transfusions must be stopped, pending a medical assessment, whenever a
                 transfusion reaction is suspected i.e. the patient develops new signs or symptoms
                 or there is a significant change in their observations. The patient‟s vital signs must
                 be recorded and a check made to ensure venous and arterial access is patent.

           6.8.3 Appendix 1 gives full details of the management of adverse reactions in adults and
                 Appendix 2 full details of the management for children.

     6.9   Rapid Infusion and Blood Warmers
           6.9.1 The routine warming of blood is not necessary

           6.9.2 Blood warmers increase the risk of bacterial growth, so should not be used
                 routinely, except in the following circumstances

                      Blood transfused at a rate of greater than 50 millilitres per kilogram per hour
                      Infants requiring exchange transfusions
                      Patients who have clinically significant cold agglutinin antibodies

           6.9.3 If blood warming is required, this must only be done using a specifically designed
                 commercial device, with a visible thermometer and audible alarm that ensures the
                 blood is not warmed over 410C.

           6.9.4 The device must be monitored and validated every 12 months as blood warmers
                 are extremely dangerous if they malfunction

     6.10 Storage
          6.10.1 Blood is to be stored only in a purpose built, alarmed blood bank at between 2 – 8
                 0
                   C to prevent the risk of bacterial growth. Note: the alarm is connected to the
                 switchboard to alert to any malfunction.

           6.10.2 Blood must NEVER be stored in a ward fridge, as the temperatures in these fridge
                  are not low enough

           6.10.3 Cross-matched blood units are stored for 48 hours in the issue fridge, after which
                  time they are taken back to the laboratory

           6.10.4 Platelets and fresh frozen plasma (FFP) must not be refrigerated but transfused as
                  soon as possible to ensure products are at optimum quality

     6.11 Transportation
          6.11.1 Blood components/products must be transported between sites in a verified and
                 validated blood box designated for this purpose

           6.11.2 The person packing the product/component must record the time and date it was
                  placed into the box and the time for which storage would be satisfactory or the
                  time the product must be returned to blood bank
           6.11.3 Confirmation of receipt of correct product must be returned to the laboratory: using
                  Blood Bank SOP 305 (Appendix 5). This is to comply with the Blood and Safety
                  Quality Regulations and to ensure the provision of a validated “cold chain“
                  protocol.

     6.12 Documentation of Incidents/Reactions
          6.12.1 All incidents must be documented on a Trust Adverse Incident Reporting (AIR)
                 Form, available on all wards

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               6.12.2 The original (top) copy of the AIR must be sent to the Risk Management
                      Department immediately and a copy given to the Hospital Transfusion Practitioner
                      who, in conjunction with the Blood Bank Manager, will ensure follow up and any
                      actions taken.

               6.12.3 Any “wrong blood component in wrong patient” or other major incident must be
                      recorded as a Serious Untoward (RED) Incident and fully investigated in
                      accordance with the Trust Policy6

               6.12.4 All adverse reactions must be documented as fully as possible on an Adverse
                      Reaction Form available from the Blood Bank and the form returned to the
                      Hospital Transfusion Practitioner immediately

               6.12.5 All incidents must be recorded in the patient‟s notes

               6.12.6 The transfusion unit and attached giving set must be sent to the Blood Bank
                      immediately

               6.12.7 SHOT/SABRE reporting will be undertaken by the Hospital Transfusion
                      Practitioner and follow up and actions documented and reports made available to
                      the Hospital Transfusion Practitioner

               6.12.8 All adverse incidents and reactions will be discussed by the Hospital Transfusion
                      Team and reported to the Hospital Transfusion Committee

 7. TRAINING REQUIREMENTS
     7.1 The handling of blood products forms part of the Trust‟s Core Essential Skills and Training
         requirements, as identified by the Training Needs Analysis monitored through the Essential
         Training Needs Tracker and monitored through the divisional structure

     7.2 The Hospital Transfusion Practitioner will lead the Education and Training programme for
         all staff involved in the handling of blood components, in accordance with the European
         Blood Directive

     7.3       Annual updates are mandatory for all staff groups who handle blood
              components/products. There is an e-learning module available for Doctors / Nurses (SNBS
              - ORAS website) and on the Trust‟s Learning and Development site.7


     7.4 Training sessions for different staff groups are advertised in „The Link‟, The Learning
         Pages or on the Learning and Development Zone and can be booked via this website or
         the Administrator on extension 6304.

     7.5 There is an approved Trust Competency for administration of blood components
         (Transfusion Competency) every 3 years. Staff must be assessed by a Level 3 Assessor
         and this applies to all staff who administer a blood component to a patient

     7.6 There are also approved trust competencies for:
          Phlebotomy and Venous Blood Sampling (Adults)
                   Phlebotomy, Heel Pricks and Arterial Blood Sampling in Neonates
                   Post Operative Reinfusion of Shed Blood - Theatres and Recovery
                   Post-operative reinfusion of patient‟s own shed blood – Ward/Clinical Area

      6
          Policy for the Management of Serious Untoward Incidents
      7
          Moodle
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          Anyone taking blood samples for cross matching must repeat competency training every
           three years. Right patient, right blood - NPSA

 8. REFERENCES AND ASSOCIATED DOCUMENTATION

     External
     The Blood Safety and Quality Regulations 2005 SI 2005/50. London: The Stationery Office.
     www.opsi.gov.uk

     Better Blood Transfusion – Appropriate Use of Blood. London. Department of Health
     www.dh.gov.uk

     UK Blood Safety and Quality Regulations 2005. Implementation of the EU Blood Safety
     Directive: Background and Guidance on reporting Serious Adverse Events & Serious Adverse
     Reactions. London. MHRA www.mhra.gov.uk

     SABRE – A User Guide: UK Blood Safety and Quality Regulations 2005 – Implementation of
     the EU Blood Safety Directive. London. NHRA www.nhra.gov.uk

     Patient Briefing: Right Patient, Right Blood. London. NPSA www.npsa.nhs.uk

     Implementation of Competencies for Blood Transfusions. London NPSA. www.npsa.nhs.uk

     Serious Hazards of Transfusion Annual Reports. 2007. www.shot-uk.org

     Guidelines for :the Clinical Use of Red Cell Transfusions, British Committee for Standards in
     Haematology Blood Transfusion Task Force in collaboration with the Royal College of Nursing
     and the Royal College of Surgeons of England. British Journal of Haematology 2001; 113, 24-
     31

     Transfusion Guidelines for Neonates and Older Children. British Journal of Haematology, 124,
     433–453.

     Guidelines for the Use of Platelet Transfusions. British Committee for Standards in
     Haematology, Blood Transfusion Task Force, British Journal of Haematology, 2003, 122, 10–23

     Guidelines for the Use of Fresh-Frozen Plasma, Cryoprecipitate and Cryosupernatant. British
     Committee for Standards in Haematology, Blood Transfusion Task Force, British Journal of
     Haematology 2004, 126, 11–28

     Handbook of Transfusion Medicine (2007), D.B.L. McClelland, Fourth Edition. The Stationary
     Office Norwich.

     Internal
     Policy for the Management of Adverse Incidents and Near Misses
     Policy for the Management of Serious Untoward Incidents
     Refusal of Blood Components Guidelines
     Trust Transfusion Guidelines

 9. MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF,
    PROCEDURAL DOCUMENTS
      Audits

      9.1 The transfusion laboratory is accredited by the Clinical Pathology Accreditation (UK) Ltd
          (CPA and is compliant with the Medicines and Healthcare Products Regulatory Agency


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         (MHRA) requirements. This is monitored through the annual MHRA compliance report and
         inspections

      9.2 The Phlebotomy Clinical Educator undertakes an audit against a modified standard from
          the Phlebotomy and Venous Blood Sampling Policy (Adult) audit document (Appendix 1) to
          ensure blood samples taken for transfusion purposes are obtained and labeled in
          accordance with local protocols (based on National Guidelines)

      9.3 The Hospital Transfusion Practitioner undertakes an Identity Band audit against both this
          and the Patient Identification Policy to identify any training needs for direct teaching
          resources

      9.4 The Hospital Transfusion Practitioner undertakes monthly review of the persons competent
          to collect blood to ensure annual training requirements are being met. an audit of incidents
          to ensure follow up action is recorded

      9.5 The Hospital Transfusion Practitioner reviews all adverse transfusion reactions transfusion
          together with adverse incidents and near misses associated with any aspect of blood
          transfusion

      Monitoring
      9.6 All audits are reported to the Hospital Transfusion Committee

      9.7 Trends or themes identified as a result of adverse incidents are reported to the Hospital
          Transfusion Committee

      9.8 The Hospital Transfusion Committee provides a bi-annual report, including compliance with
          this policy, to the Governance and Quality Committee

      Learning
      9.9 The Hospital Transfusion Committee will develop any required action plans resulting from
          audit and the investigation and review of adverse incidents.

      9.10 The Hospital Transfusion Practitioner, supported by other members of the Hospital
         Transfusion Team, will monitor implementation of the action plans

      9.11 The Hospital Transfusion Practitioner will ensure that any identified risks associated with
         transfusion are presented to the Risk Assurance Committee for consideration of entry onto
         the Trust Risk Register. The Risk Assurance Committee will then monitor the progress of
         actions against the stated risks.

      9.12 The Chair of the Risk Assurance Committee will ensure that should it appear that the
         timescales for implementation of the actions to mitigate the identified risks are not going to
         be achieved, that a member of the Hospital Transfusion Team is invited to the next
         Committee meeting to provide an update




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                                                                                               Appendix 3

                       ADMINISTRATION: NEONATES AND OLDER CHILDREN

   1. Parental Information
      1.1 Parents should:

                  Be informed of the reason for the transfusion
                  Be involved in a discussion about the risks and benefits
                  Be informed of any other options
                  Be offered information leaflets
                  Consent to the transfusion, if it goes ahead (Note: it is appropriate

   2. Routine checks before administration
      2.1 The following checks should be undertaken

                  The details on the unit of blood, printed labels and baby/child‟s identity bands must
                   all match; to ensure the right blood component type is given to the right baby or
                   child
                           o If, for any reason, the parent or child cannot confirm identity, two staff
                               should do so by the bedside
                  The blood group and Rhesus group are compatible with those of the patient
                  The unit „use before‟ date is current
                           o Should any of the above checks highlight a discrepancy, the blood
                               component(s) must not be used and returned to the blood bank
                               immediately
                  If cover with paracetamol and/ chlorphenamine is prescribed and administer in a
                   timely manner.

   3. Types of transfusion
             For neonates and patients under 1 year of age, CMV negative units are
                recommended.
             Some other groups of children may also require CMV negative blood products,
                e.g. a patient who had an alloegenic Stem Cell Transplant. This should be
                prescribed on the IV chart.
             In an emergency situation then the clinical needs of the patient may require
                transfusion with the „Next Best Product‟ and it may not be necessary to obtain
                CMV negative products for example.
             Some babies / children are severely immuno-compromised and require irradiated
                blood. This will be indicated on the label and on the front of the baby / child‟s notes
                and the request form

     4. Procedure for low volume blood transfusion
              Wearing gloves, connect blood-giving set to the blood bag with the 3- way tap
                closed to the filter – this keeps the blood free from contamination
              Connect 50ml syringe to the 3-way tap
              Connect extension set to the remaining 3-way tap port
              Open 3-way tap to syringe and blood filter only
              Withdraw required amount of blood plus an extra 2mls for priming of infusion lines
                and „dead spaces‟. This will ensure the baby is not inadvertently given too much
                fluid
              Purge air bubbles in syringe back into blood bag
              Open 3-way tap to extension tubing and purge blood through the extension set line
              Take the transfusion to the baby/child, complete with blood bag, filter and syringe



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   5. Administration of blood transfusion
         Check the baby/child‟s identify against both name labels: wrists and ankles and the
          compatibility label on the blood
         Flush the cannula with Sodium Chloride 0.9%
         Only connect the blood once these checks are satisfactory,
         Two nurses must check the pump has been set at the correct rate and volume limit and
          that the 3-way tap is open to the baby/child (where syringe driver used), not the blood
          bag

   6. Observations
         Document baseline observations of temperature, pulse, respirations and blood pressure
           prior to start of transfusion
         Continually monitor the apex and respiratory rate during the transfusion, so any adverse
           reactions can be detected
         Check and record temperature, pulse, respirations and blood pressure at 15 minutes, 30
           minutes and 60 minutes then hourly until completion. Note: severe reactions most
           frequently occur within the first 15 minutes of each transfusion.
         Have the intravenous site easily visible
         For neonates only, record neonatal intravenous extravasation score (NESS) hourly on
           IV chart

   7. Feeding during transfusion (neonates)
      7. 1. Routine stopping of feeds is not necessary but stopping or reducing feeds should be
            considered for babies in intensive care to protect baby from fluid overload with any of
            the following:

                  History of poor feed tolerance or abdominal distension
                  History of Inter Uterine Growth Retardation - IUGR (Less than 9th centile)
                  History of poor Doppler‟s / absent/reduced end diastolic flow
                  Recent changes in feeds e.g. addition of fortifier

       7.2 Babies in special care with
             History of poor feed tolerance
             History of suspected necrotizing entero-colitis (NEC)

             Note: If feeds have been reduced or stopped check blood sugar half way through the
             transfusion: to ensure vulnerable babies do not suffer from low blood sugar

   8. Furosemide
      8.1 Furosemide is not needed routinely for top-up transfusions but it should be considered
          for:
            Oxygen dependent babies with chronic lung disease
            Oedematous babies

       8.2If Furosemide has been prescribed
              Set the volume limit for half the total volume – to ensure the baby does not
                become fluid overloaded and adequate checks are made during the infusion
              Once administered, reset the volume limit for the remainder of the transfusion
   9. When the transfusion is complete
              Flush the cannula with Sodium Chloride 0.9%
              Disconnect the blood giving set from the pump
              Dispose of the unit/s and the giving set in the yellow clinical waste bags
              Complete the middle section of the compatibility label and return it to the blood
                bank as soon as possible
              Check the haemoglobin level 24 hours later
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   10.   Documentation – Paediatrics and Neonates
         The following should be documented:
                The blood availability record (red card) should be secured in patient notes
                The reason for the transfusion should be documented prior to requesting
                  component/product
                The amount and type of blood given
                Any adverse effects
                Completion of the blood compatibility labels. Two registered practitioners must
                  sign in the appropriate place and affix to the current continuation sheet in the
                  patient notes (returning the third section to blood bank)
                The clinical response and whether the transfusion was effective should be
                  recorded.
                Any relevant parent information leaflets given




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                                                                                               Appendix 4

     CLINICAL INDICATION FOR THE ADMINISTRATION OF BLOOD AND BLOOD PRODUCTS
                                –   NEONATES ONLY

           1. Symptoms of anaemia
                 Tachypnoea
                 Tachycardia
                 Recurrent apnoea
                 Oxygen requirement
                 Poor feeding
                 Failure to gain weight

           2. Transfusion triggers
                 Given to ventilated ill neonates requiring oxygen to keep haemoglobin levels
                  more than 12 g/dl
                 CPAP in oxygen to keep Hb. more than 12 g/dl, CPAP in air to keep Hb more
                  than 10 g/dl
                 Nasal prong oxygen to keep Hb. more than10 g/dl
                 In air, poor feeding and growth, reticulocytes less than 4.0% to keep Hb more
                  than 8 g/dl
                 In air, feeding and growing, reticulocytes less than 4.0% to keep Hb more than7
                  g/dl

           3. Calculation for Top-Up Transfusion
              To ensure adequate volume to reduce the need for repeat transfusions and hence
              multiple donor exposure

                    Packed cells – (desired Hb – actual Hb) x wt in kg X 4.
                    Or; 10 – 15mls/kg of packed cells.

               Usage

                    Blood should be used within 30 minutes of removal from fridge
                    Transfusion should be completed within a maximum of 4 hours
                    Aim for the shortest time possible for infusion – look at the amount in mls being
                     prescribed

           4. Platelet Transfusion Triggers

                    Platelets are prescribed for very pre-term infants with sepsis or disseminated
                     intravascular coagulopathy (DIC)
                    Platelet dose is 10 ml/kg

               Usage
                 Platelets are stored at room temperature and should be kept agitated to prevent
                   clumping.
                 Platelets should be infused within 1 hour of arrival on the Neonatal Intensive
                   Care Unit
                 Platelets are withdrawn for bag using a mini-spike.
                 Transfusion should be administered over 30 - 60 minutes




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                                                                                            APPENDIX 5

                 TRANSPORT OF BLOOD AND BLOOD COMPONENTS (SOP 305)

1. Introduction
   This procedure must be followed, to ensure that there is a complete audit trail for blood
   components to be transfused at hospitals other than QAH or SMH. The procedure satisfies the
   “cold chain“ requirements as laid down in the Blood Safety and Quality regulations (50) 2005.
   This covers the full process from provision of compatible blood components to the final fate and
   documentation of every product.

The following hospitals / care centres are routinely served:

         Petersfield Hospital*

         Rowans Hospice

         Spire Portsmouth Hospital (ex BUPA) Havant

         Gosport War Memorial Hospital*

* These hospitals have suitably validated blood storage fridges

4. Transport procedure
   2.1 Commencement

               Contact the Senior Nurse at the intended destination to confirm that blood
                components are ready for dispatch. State the patient‟s details and the amount and
                type of product to be dispatched
               Sign the compatibility labels
               Organise suitable transport
               Place the blood components in a validated transport box with sufficient cool packs to
                fill any „dead space‟
               Fill in the “Blood in Transit Form” clearly stating the destination, date and time packed,
                expiry time and person who packed the box
               Label the box – “URGENT BLOOD FOR (NAMED) HOSPITAL”

   2.2    On arrival

               On arrival at destination the box MUST be unpacked and the units placed in to the
                designated blood fridge. In the absence of a designated blood fridge, the product can
                be stored in the insulated box for an absolute maximum of 4 hours

   2.3    Transfused blood
          All units that are transfused MUST have the middle part of the compatibility label completed
          and returned to the issuing blood bank as soon as possible

   2.4    Unused blood
          Any used blood MUST be returned to the issuing blood bank in a transport box as above




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