POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS

Transcription

1 POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Document Author Written By: Transfusion Practitioner / Transfusion Laboratory Manager Authorised Authorised By: Chief Executive Date: July 2015 Lead Director: Clinical Director, Clinical Support, Cancer and Diagnostic Services Date: 17 th November 2015 Effective Date: 18 th December 2015 Review Date: 17 th December 2018 Approval at: Policy Management Group Date Approved: 17 th November 2015 POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 1 of 44

2 DOCUMENT HISTORY (Procedural document version numbering convention will follow the following format. Whole numbers for approved versions, e.g. 1.0, 2.0, 3.0 etc. With decimals being used to represent the current working draft version, e.g. 1.1, 1.2, 1.3, 1.4 etc. For example, when writing a procedural document for the first time the initial draft will be version 0.1) Date of Issue Version No. Date Approved Director Responsible for Change Nature of Change Ratification / Approval AD Acute Directorate Draft CD Hospital & Draft Ambulance CD Hospital & Ambulance Review Clinical Standards Group CD Hospital & Ambulance Approval Policy Management Clinical Director, Clinical Support, Cancer and Diagnostic Services /11/2015 Clinical Director, Clinical Support, Cancer and Diagnostic Services Clinical Director, Clinical Support, Cancer and Diagnostic Services Ratification Approval Slight amendments to current policy approved NB This policy relates to the Isle of Wight NHS Trust hereafter referred to as the Trust Group Clinical Standards Group Policy Management Group Corporate Governance & Risk Sub- Committee POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 2 of 44

3 Contents 1 Executive Summary Introduction Definitions Scope Purpose Roles and Responsibilities Policy detail/course of Action Consultation Training Monitoring Compliance and Effectiveness Links to other Organisational Documents References Appendices POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 3 of 44

4 1 Executive Summary 1.1 The transfusion of blood and blood components is an important, often lifesaving, part of the treatment of many patients. It is also a procedure that has an element of risk, with errors potentially leading to the death of or long term damage to a patient who receives the wrong blood. The Trust therefore attaches the utmost importance to the correct procedures for the transfusion of blood and blood components 1.2 SHOT (Serious Hazards of Transfusion) data for 2014 have shown that nationally 40 Wrong Components were transfused. In 17 of these patient identification failure as a result of incomplete checking was the root cause. This is a fundamental element in the transfusion process and the point at which a wrong transfusion can be prevented. There were 10 ABO incompatible red cell transfusions caused by clinical errors in both collection and administration, or administration alone (SHOT 2014). Additionally there were 686 errors reported relating to Wrong Blood in Tube (WBIT) which potentially could have led to Incorrect Blood Component Transfused (ICBT). Such potentially fatal errors are preventable through consistent good practice, however audits of practice in transfusion have shown that simple preventative measures such as the patient wearing a correct ID Band, being asked to confirm their name and date of birth which is checked against the ID Band prior to procedures and labelling samples at the bedside are being overlooked. 1.3 Administering the wrong blood type is the most serious outcome of an error during transfusions. Most of these incidents are due to failure of the final checks carried out at the patient s bedside to positively identify the patient and verify the blood product to be transfused (NPSA 2006). This demonstrates the importance of correct and meticulous completion of all the steps in the transfusion process, particularly the final checks at the bedside, and not making any assumptions about the safety of the steps prior to this. 1.4 It is the shared responsibility of medical, phlebotomy, laboratory, portering and nursing staff to ensure safe and reliable, prescribing, requesting, collection of samples, testing and issuing, transporting and administering of components. All parties must be aware of their roles and responsibilities and adhere to the safe practices outlined in this policy. 1.5 This policy sets out the local requirements of the Trust based on National and European Regulations and Guidelines and must be used in conjunction with the following additional Trust s policies / Guidelines: Patient Identification Policy Maximum Surgical Blood Ordering Schedule (MSBOS) Special Blood Component Guidelines Guidelines for the use of Platelets Guidelines for the use of Fresh Frozen Plasma Protocol for the Management of Major Haemorrhage and/or Trauma in Adults and Children Guidelines for Peripheral Intravenous Cannula Care and Intravenous Drug Administration Cannulation & Venepuncture Policy Infection Control Policies POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 4 of 44

5 1.6 Compliance with the above policies, protocols and guidelines will decrease the risk of patient exposure to errors and is an important element of the risk management of patients in this Trust. 1.7 This policy will be regularly reviewed and updated by the Hospital Transfusion Committee (User Group). Significant changes will require ratification by the appropriate governance committee. 1.8 The policy will be regularly reviewed in the light of current scientific evidence and opinion. 2 Introduction 2.1 The transfusion of blood and blood components is an important, often lifesaving, part of the treatment of many patients. It is also a procedure that has an element of risk, with errors potentially leading to the death of or long term damage to a patient who receives the wrong blood. To ensure the right patient receives the right blood, strict checking procedures must be in place at each stage. Administering the wrong blood type (ABO incompatibility) is the most serious outcome of error during transfusions (Never Event). Most of these errors are due to the failure of the final identity checks carried out between the patient (at the patient's side) and the blood component to be transfused. 2.2 This policy advises all healthcare professionals, who are involved in the transfusion process, of safe transfusion practice and is the shared responsibility of all staff involved in the various stages of the Transfusion Process. 2.3 Training is an essential aspect of safe transfusion, which is required for all staff involved in the Transfusion Process. 2.4 The clinical benefits to the patient being transfused should outweigh the potential risks, the most important of these being acute haemolytic reactions, transfusion-transmitted infections and human error (especially at sample collection and labelling of pretransfusion samples). Stringent procedures must be followed to ensure that the correct blood component is given and that any adverse reactions are dealt with promptly and efficiently. 3 Definitions Authorised Health Care Professionals staff that have completed the Non MedicalAuthorisation of Blood Products course and have been assessed as competent to authorise blood products. Blood / Blood Components: Red cells (RBC), Platelets (PLT), Fresh Frozen Plasma (FFP) and or Cryoprecipitate (CRYO) hereafter referred to as Components within this document. BSQR Blood Safety & Quality Regulations (2005): EU Directives /98/EC and 2004/33/EC have been transposed into UK law through the Blood Safety and Quality Regulations 2005 (Statutory Instruments 2005/50, 2005/1098 and 2006/2013). The regulations came into force on 8 February 2005 and were implemented on 8 November POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 5 of 44

6 DATIX Trusts electronic incident reporting system. G & S Group and Save: A blood sample that has been grouped and screened for alloantibodies but compatible red blood cells have not been crossmatched. A G&S sample is valid for seven days provided the patient has not been transfused or had a sensitising event within the past three months. HTC Hospital Transfusion Committee. HTT Hospital Transfusion Team LIMS Laboratory Information System MHRA Medicines and Healthcare products Regulatory Agency. Competent Authority for blood safety. NPSA National Patients Safety Agency (Now part of NHS England) Never Event - Serious, largely preventable patient safety incident that should not occur if the available preventative measures have been implemented. NHSBT NHS Blood & Transplant PCC Prothrombin Complex Concentrate. Concentrated coagulation factors. Dosage and duration depends on the severity of the condition and on the patient s clinical condition together with laboratory results and the location and severity of the bleeding. Should be administered intravenously at no more than 3 IU per Kg body weight per minute. PID Patient Identifiable Data Q Pulse Laboratory electronic incident reporting system. SABRE Serious Adverse Blood Reactions & Events MHRA Adverse Incident reporting system. SAE Serious Adverse Event SAR Serious Adverse Reaction. SHOT Serious Hazards of Transfusion WBIT Wrong Blood in tube XM Crossmatch: A blood sample that has been grouped and screened for alloantibodies against which compatible red blood cells have been crossmatched. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 6 of 44

7 4 Scope 4.1 This policy applies to all healthcare professionals within the Trust who are involved both directly and indirectly with the transfusion process and will affect the safety and well being of patients. 5 Purpose 5.1 Due to the high regulatory standards set out in the Blood Safety and Quality Regulations, 2005 (BSQR s), monitored by the Medicines and Healthcare products Regulatory Agency (MHRA) it is paramount that staff are trained adequately and competency assessed. This policy, based on national guidelines is intended to give clear instructions on the correct procedures to be followed by all staff members involved at any stage of the transfusion process to ensure that the right patient receives the right blood component at the right time. 6 Roles and Responsibilities 6.1 Trust Board is legally responsible under the provisions of the Blood Safety & Quality Regulations (2005) (BSQR s) to ensure that there are policies and procedures in place to manage all transfusion processes. 6.2 Medical staff or other authorised Health Care Professionals are responsible for: Ensuring they are trained and assessed as competent in the skills they undertake in relation to the transfusion process. Evaluating the clinical need for the transfusion of blood / blood components taking into consideration any alternatives to transfusion and having fully explained the risks and benefits to the patient including obtaining consent. Prescribing components, taking into consideration the patients requirements in respect of the need for any Special Blood Components (see Guidelines for Special Blood Components) and the recommendations of the Maximum Surgical Blood Ordering Schedule (MSBOS). Responding to transfusion laboratory requests for additional samples as required e.g. to verify patient s blood group if a historical group is not held on the Laboratory Information System (LIMS). Fully documenting the transfusion episode in the patient s Medical Records and on the Blood Transfusion Chart including the reason for the request and any special blood component requirements. Ensuring that, if the patient is transferred from their care, a full handover to the receiving medical staff is undertaken, including details of any components already requested or required. Requesting components, ensuring that all sample labelling is in accordance with this Policy. If a telephone request, ensure the order number is recorded against POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 7 of 44

8 the transfusion episode in the patient s Medical Records and on the Blood Transfusion Chart. Taking and labelling of blood samples for laboratory testing in accordance with this Policy. Management of any suspected Adverse Transfusion Reactions (ATR s). Administering components and recording all necessary information on the Blood Transfusion Chart. Monitoring patients, including taking observations during transfusion and carrying out the appropriate actions in the event of adverse transfusion reactions. 6.3 Nursing staff are responsible for: Ensuring they are trained and assessed as competent in the skills they undertake in relation to the transfusion process. Ensuring that the patient is wearing an accurate and legible ID band at all times during the transfusion process. (See Patient Identification Policy). Taking and labelling blood samples for laboratory testing in accordance with this Policy. Receiving and recording receipt of the component in the Clinical area by either use of the electronic system or by paper receipt. Preparing the patient for Transfusion. Administering components and recording all necessary information on the Blood Transfusion Chart and by inputting data into the electronic system if in use. Monitoring patients, including taking observations during transfusion and carrying out the appropriate actions in the event of adverse transfusion reactions. Reporting of suspected transfusion reactions or other related incidents, to the medical staff or other appropriately trained & competent Health Care Professional. Completing the audit trail by recording the transfusion episode outcome via the electronic system if in use, or by paper record and returning it to the Blood Transfusion Laboratory as soon as possible. Ensuring that transfusion of components is commenced within 30 minutes of receipt or components are returned to the Blood Transfusion Laboratory within 30 minutes if not required Informing Blood Transfusion Laboratory staff of any components which have not been transfused and have been discarded in the clinical area. Actioning requests from the Transfusion Laboratory in response to any recall procedure being instigated and responding to any further action required. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 8 of 44

9 6.4 Phlebotomy staff responsibilities are restricted to: Ensuring they are trained and assessed as competent in the skills they undertake in relation to the transfusion process. Taking and labelling of blood samples for laboratory testing in accordance with the Trust s Policy. 6.5 Hospital Blood Transfusion Laboratory staff are responsible for: Ensuring they are trained and assessed as competent in the skills they undertake in relation to the transfusion process. Checking that the labelling of request forms and blood samples comply with this policy and the Trust s Patient Identification Policy. Providing an order number to a medical officer or other authorised Health Care Professional who is requesting components via telephone. Blood grouping, antibody screening and crossmatching of samples. Including any additional investigations and requesting any additional samples deemed necessary. Labelling and issuing blood and blood components. Traceability, ensuring there is a full audit trail recorded electronically or by a paper based system. Investigating and reporting of suspected Serious Adverse Events and Reactions (SAE & SAR s), reporting to SHOT / SABRE as necessary. Initiating/actioning component recall procedures in response to a recall being initiated externally (e.g. NHSBT) or internally. 6.6 Porterage staff and Hospital Transport Drivers responsibilities are restricted to: Ensuring they are trained and assessed as competent in the skills they undertake in relation to the transfusion process. Collection and delivery of samples and request forms. Completion of the Blood Collection Slip which must include the patient s full name, date of birth and IW number. Removal of components through the electronic blood tracking system and delivery to the clinical area in a timely manner, ensuring receipt at the clinical area is recorded. Return of components to the Issue Refrigerator or Blood Transfusion Laboratory via the electronic blood tracking system as soon as possible if necessary. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 9 of 44

10 6.7 Ward / Departmental Managers and Clinical Leads are responsible for ensuring that all staff working within their areas: Have completed training in Safe Transfusion Practice by completing the on-line module on a yearly basis. Are assessed as competent in the skills they use as part of the Transfusion Process by completing the National Patient Safety Agency (NPSA) Competency Assessments (available on the Intranet) on a 2 yearly basis or by the completion of the on-line competency assessment on the Trusts e-learning module. 6.8 Hospital Transfusion Team (HTT) is responsible for: Writing and/or reviewing transfusion policies and procedures, ensuing that they are fit for purpose and referring them to the HTC for approval. Reviewing the arrangements for training of staff in transfusion policies and procedures. Reviewing serious adverse events and reactions, including near misses and reporting findings to the HTC and externally to SHOT/SABRE as applicable. Reviewing the appropriateness of blood transfusion and making recommendations about the proper use of components and reporting findings to the HTC. Recommending corrective action in transfusion practice, where indicated. Reviewing new evidence and best practice guidelines around transfusion, the efficient use of components or alternatives to transfusion and making recommendations to the HTC. Providing assurance to the HTC that systems are in place to minimise risk to patients. Ensuring that new evidence and practice from national reports and guidance are implemented. Providing continued education in transfusion medicine for all relevant members of staff. 6.9 Hospital Transfusion Committee (HTC) is responsible for: Reviewing transfusion policies and procedures as referred from the HTT. Reviewing the arrangements for training of staff in transfusion policies and procedures. Reviewing serious adverse events and reactions, including near misses as referred by the HTT. Reviewing the appropriateness of blood transfusion and making recommendations about the proper use of components. Recommending corrective action in transfusion practice, where indicated. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 10 of 44

11 . Reviewing new evidence and best practice guidelines referred by the HTT around transfusion, the efficient use of components or alternatives to transfusion and making recommendations for implementation. Ensuring that recommendations, based on new evidence and practice, from national reports and guidance are implemented Providing assurance to the Trust Board that systems are in place to minimise risk to patients. Promoting continued education in transfusion medicine for all relevant members of staff. 7 Policy detail/course of Action 7.1 Collection and Labelling of Blood Samples for Pre Transfusion Testing Request Form Request forms MUST be clearly completed in legible handwriting. Addressograph labels may be used on the request forms only and MUST be attached to ALL copies of any multi-part forms. Addressograph labels MUST be clear and without alteration. The form MUST be signed by the requesting medical officer or other authorised Health Care Professional. Requests for Group & Save MUST be made on a Blood Sciences request form. Requests for Crossmatched red cells MUST be made on the Blood Transfusion Crossmatch Request form unless a telephone request is made Samples Samples MUST be collected and labelled as one uninterrupted process involving one member of staff and one patient. One patient must be completed before commencing any further patients The staff member collecting the sample MUST ensure that they have positively identified the patient immediately prior to collection by the use of open questioning i.e. by asking the patient to state their full name and date of birth Identification details provided by the patient MUST be checked / confirmed against the patient s ID band and request form (it is acceptable to confirm by documentation only in an outpatient setting). Children, patients suffering from dementia or the unconscious or sedated must be identified by the information on their ID band only. Refer to The Trust s Policy for Patient Identification. Sample labelling must be completed by the staff member taking the sample. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 11 of 44

12 The sample label must be completed immediately after collection, not remotely or prior to the procedure. All samples MUST be completed accurately in legible handwriting without alteration using indelible ink or by using a label produced by the electronic blood tracking system which uses the patient s ID band barcode the together with the staff members identification barcode. o o A staff identification barcode MUST ONLY be used by the person it was issued to NO other Addressograph or electronically printed labels are acceptable on samples The Blood Transfusion Laboratory cannot accept inadequately or inaccurately labelled samples. (See Organisation s Patient Identification Policy). The minimal acceptable labelling requirements on samples are: o Surname o Forename (for unnamed infants use MI or FI). o Date of Birth o IW number o U Numbers will be issued by ED and Maternity in the event of a computer failure o E Numbers will be issued in the event of a Major Incident o Signature of person taking the sample o Date of collection For emergency admissions of unknown patients, the minimal acceptable labelling requirements are: o Surname: Unknown o Forename: Female or Male o Hospital No: IW Number or Unique U or E Number o Signature of person taking the sample o Date of collection Two sample rule A second sample will be requested by Transfusion Laboratory staff to confirm the ABO group of any patient requiring blood components who has a current sample in the laboratory but has no historical group recorded on the LIMS The second sample MUST be taken independently of the original sample. In an urgent situation only group O red cells will be issued until the second sample has been processed Note: for neonates/children for whom it is not possible to obtain a second sample in an urgent situation, group specific red cells will be issued after a second group check on the original sample. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 12 of 44

13 7.1.4 Timing of sample collection for pre-transfusion testing To ensure that the blood sample used for crossmatching is representative of a patient s current immune status the following timings for sample collection are required: Patient Type Patient transfused or pregnant in last 3 months Patient NOT transfused or NOT pregnant in last 3 months Sample Storage at 2 o 8 o C (once tested) Sample valid up to 3 days* Sample valid Up to 7 days *This is the time between the sample being taken and the subsequent transfusion Note: For routine crossmatches, samples should ideally be taken 5-7 days before the date red cells are required. Where the patient has been transfused or pregnant within the preceding three months or when such information is uncertain or unavailable, a sample should be collected no more than 48 hours in advance of the actual transfusion. The transfusion should ideally be completed within 72 hours of sample collection. 7.2 Requesting Blood and Blood Components. It should be remembered that patients have the right to refuse any transfusion of components. This should be clearly documented in the patient s Medical Records / consent forms. This applies to all patients. (See guidance relating to Jehovah s Witnesses). Non essential and out of hours requests for transfusion and overnight administration of blood components should be avoided wherever possible because of the increased risk of errors Routine Requests (over 24hrs) Red cells Requests for transfusions MUST be made by a medical officer or other authorised Health Care Professional by: o o Completing the Blood Transfusion Crossmatch Request form and should be made at least 24 hrs in advance of the intended transfusion Contacting the Blood Transfusion Laboratory and making a telephone request. If a G&S has been taken then a telephone request MUST be made For ALL telephone requests, the Blood Transfusion Laboratory staff will give the requesting medical officer or other authorised Health Care Professional an order number to confirm the request. The requestor MUST write this number in the patient s Medical Records and Blood Transfusion Chart together with the reason for transfusion. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 13 of 44

14 All requests for blood components MUST give full patient identification details, including: o Surname o Forename o Date of Birth o IW Number The full indication for the request MUST be provided including the underlying cause (or condition) that necessitated the transfusion. Details of the quantity and type of component required including any special requirements and the time and date it is required MUST be stated. The location of the patient at the time of the request MUST be stated together with the location where the blood components are to be given (if different). Clinical details, giving information about the patient s diagnosis should be provided, wherever possible including any past obstetric and transfusion history. Other Components (e.g. Platelets (PLT), Fresh Frozen Plasma (FFP), Cryoprecipitate (CRYO), Prothrombin Complex Concentrate (PCC) A telephone request MUST be made by a Medical Officer or other authorised Health Care Professional in the event of other components being required Urgent Requests (Within 24hrs) If the transfusion is required URGENTLY or within 24 hrs the requesting practitioner MUST ring the Blood Transfusion Laboratory and make a Telephone Request. (See the Trust s Major Haemorrhage protocol) 7.3 Consent for Transfusion It is the sole responsibility of Medical Staff or other authorised Health Care Professional to obtain a valid consent for the transfusion. As with any emergency treatment, the need for consent must not prevent or delay essential urgent transfusion, but the presence of a valid Advance Decision Document declining transfusion should always be respected. The patient MUST be fully informed of the risks, concerns and any alternative therapies. This information MUST be recorded on the Blood Transfusion Chart and in the patient s Medical Records. Leaflets Will I need a Blood Transfusion / Platelets are available from the Transfusion Practitioner or via the Intranet. Patients transfused when it is not possible to obtain consent prior to transfusion should be provided with information retrospectively. This is important as transfused patients are no longer eligible to act as blood donors. For the same reason, patients who have given consent for possible transfusion during surgery should be informed if they actually received blood while under anaesthesia. A leaflet Unexpected Transfusion is available from the Transfusion Practitioner. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 14 of 44

15 Patients needing long-term transfusion support should have a modified form of consent and consent is not required for each transfusion episode providing consent has been clearly documented within the past year. For paediatric patients the parents must give a valid consent to the transfusion and should be fully informed of the risks, concerns and any alternative therapies. Consent should be clearly documented on the Blood Transfusion Chart and within the patient s Medical Records. A leaflet A Parent s Guide to Transfusion is available from the Transfusion Practitioner. 7.4 Prescription of Components It is the sole responsibility of Medical Staff or other authorised Health Care Professional to prescribe blood or blood components. It is essential that all the following patient identification details be recorded on the Blood Transfusion Chart: o Surname o Forename o Date of Birth o IW Number The indication for the transfusion MUST be documented in both the patient s Medical Records and on the Blood Transfusion Chart. The prescription must specify: o The type of component to be administered, including any special requirements e.g. Irradiated, CMV negative, Emergency O Negative Blood or Other i.e. washed cells etc (See Guidelines for Special Blood Requirements) o Number of Units / Quantity to be given o Duration of transfusion. (Up to maximum permitted time) o o Any special instructions, e.g. any medication required before or during the transfusion Wherever possible, routine transfusions should not be carried out at night where reduced Nursing Staff and/or reduced lighting may contribute to a Transfusion Reaction being missed. Where the patient s condition clinically indicates a transfusion overnight, care must be taken that the patient is strictly monitored to ensure that a Transfusion Reaction is noted immediately. When the decision to transfuse is made, it is imperative that the prescriber considers all risks to the patient and that any steps to reduce that risk must be taken. 7.5 Collection and Delivery of Components Only staff trained and assessed as competent in using the electronic blood track kiosk are permitted to access the Issue Fridge. Access is controlled by use of individualised bar-coded ID cards. Under no circumstances must ID cards be lent / borrowed between staff or given to untrained staff. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 15 of 44

16 7.5.2 Only components for ONE patient MUST be removed from the Issue Fridge at a time. Collecting components for more than one patient at the same time is NOT PERMITTED The person collecting the blood MUST have documentation specifying the patient identification details, which MUST be checked against the patient identification displayed by the electronic blood track kiosk This will be one of the following: Patient s Medical Records Blood Transfusion Report Blood Transfusion Chart Blood Collection Slip (This may be relayed by telephone message) The following details MUST match: Surname Forename Date of Birth IW Number The donation number on the unit must match the donation number on the compatibility label. Any discrepancy must be bought to the attention of a member of Blood Transfusion Laboratory staff All components MUST be removed by scanning the component unit number via the electronic blood track kiosk. IT IS NOT PERMISSABLE for ANY component to be removed from the Issue Room without first scanning through the kiosk unless otherwise instructed by Laboratory Staff It is important that the compatibility label is date / time stamped prior to removing the component from the Blood Issue Room unless electronic blood tracking compatibility labels are in use Red blood cells (RBC S) MUST be stored in a designated, purpose built Blood Transfusion Laboratory Refrigerator at 4 o C. Under no circumstances MUST they be placed in a domestic refrigerator. Single red cell units should be transported in a red Blood Component Transit Bag. Once removed from the Blood Issue Fridge, collected units must be delivered directly to the clinical area. If red cells have been received in the clinical area but a decision made not to transfuse for any reason they MUST be returned to the Issue fridge WITHIN 30 minutes of removal. Multiple units of red cells MUST be transported in a sealed cold box. Sealed cold boxes are validated for 4 hours. Cold Boxes MUST be packed in accordance with the instructions in the Blood Issue Room. Once packed and sealed, the cold box MUST be delivered directly to the clinical area and if not required MUST be returned unopened to the Issue fridge WITHIN four hours of removal. Red cells issued in a sealed cold box MUST be transfused or returned within the 4 hour period. Once sealed, the box should not be opened unless required. Once opened, the cold chain has been broken and POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 16 of 44

17 the red cells must be transfused within 4 hours or returned to the Issue Fridge within 30 minutes. Red cells for delivery to another hospital MUST be sealed in a cold box and not be opened unless required. Requesting medical officers MUST inform the Blood Transfusion Laboratory of the intention to transfer Blood Components to another hospital BEFORE removal from the Issue Fridge Platelets (PLTS) MUST NOT be refrigerated; they MUST be stored in a Platelet Incubator at 22 o C and should be transported in a Blood Component Transit Bag Fresh Frozen Plasma (FFP) is stored deep frozen below -25 o C. Once thawed, should be transported at ambient temperature in a Blood Component Transit Bag. Multiple units of FFP for the same patient may be carried in the same transit bag Cryoprecipitate (CRYO) is stored deep frozen below -25 o C. Once thawed, MUST be transported at ambient temperature in a Blood Component Transit Bag and MUST NOT be refrigerated once thawed. Multiple units of CRYO for the same patient may be carried in the same transit bag. 7.6 Receipt of Components If the components are in a sealed cold box, the box should NOT be opened and the packing label receipted with the date and time of arrival. Otherwise on arrival in the clinical area, a trained member of staff (medical practitioner, registered nurse, operating department practitioner/ assistant) MUST examine the unit and check: The component details correspond with the Compatibility Label attached to the component. This will carry the following information: o Donor unit number and group o Surname o Forename(s) o IW Number o Date of Birth o Patients Blood Group The Compatibility label MUST be completed with the time & date of arrival in the clinical area, together with the receiver s signature. If in use, the electronic tracking system should be used to receipt the unit on the clinical area by scanning the barcode on the electronic Compatibility Label together with the identification barcode of the member of staff. Full Patient Identification e.g. o Surname o Forename o Date of Birth o IW Number (NOT case note Number or NHS Number) o Correct Blood Group o Expiry date of unit o Integrity of the pack POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 17 of 44

18 o Any unusual colour, turbidity (sediment or particles), or clumping of the contents The Compatibility Label MUST remain attached to the component throughout the transfusion. Transfusion of components should commence within 30 minutes of receipt in the clinical area. If red cells have been received in the clinical area but transfusion not started within 30 minutes of receipt and the component is subsequently required for transfusion the unit MAY remain on the ward but MUST be transfused within 3.5 hours (e.g. 30 minutes hours = Total 4 hours). 7.7 Return of Blood Components If the transfusion of components cannot be commenced within 30 minutes the unit should be returned to the Issue Fridge by trained staff and scanned through the electronic tracking system. If the electronic system alerts then Blood Transfusion Laboratory staff MUST be informed and the component handed to them. 7.8 Preparation of the Patient If possible the procedure MUST be explained to the patient and consent obtained. The NHS information sheet Receiving a Blood Transfusion is available from the Transfusion Practitioner if required. N.B. Jehovah s Witnesses will be identified by a RED clasp on the wristband. Ensure all red wristband clasps are identified as to the reason they are in place and acted on accordingly Prior to requesting collection of components from the Issue Fridge, ensure adequate venous access is in situ Prior to commencing the transfusion, obtain baseline vital signs, including:- Temperature Pulse Respiration Blood Pressure The patient MUST also be questioned about any symptoms such as chills, itching, rashes, muscle aches or difficulty in breathing prior to the transfusion commencing as these symptoms may be mistaken for a transfusion reaction The patient MUST be able to be observed at all times in a safe clinical environment and made as comfortable as possible Pre-medication of the patient may be required in certain circumstances which will be identified by the clinicians. 7.9 Pre-Infusion Checks. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 18 of 44

19 7.9.1 There MUST be a fully completed Blood Transfusion Chart which has been signed and dated by the medical staff or other authorised Health Care Professional detailing: The patients, Forename, Surname, Date of Birth and IW Number The number and type of component to be transfused over a specified time Any special requirements e.g. CMV Negative / Irradiated Units Any concomitant drugs / premedication required Prepare the following equipment: Sterile blood administration set primed with normal saline 0.9%. Gloves (non sterile), must be worn when handling blood and blood components. If required, a volumetric infusion pump with dedicated giving set which has been specifically identified as being suitable for blood transfusion by the manufacturer. Components MUST be transfused by a separate intravenous route from all other infusions. No other solutions / drugs MUST be added directly to any blood component. If a multiple lumen venous catheter is in situ, this may be used, one lumen must be solely used for blood transfusion. In exceptional circumstances, where it is not possible to have more than one intravenous access point and where withholding a drug could be deemed detrimental, the transfusion should be stopped briefly and a double lumen needle free device with an anti-reflux valve fitted. This should be flushed prior to recommencing the transfusion with Normal Saline (Sodium chloride 0.9%). (Opioid PCA system must be given via a non return valve). Components MUST be infused through a blood giving set fitted with a 200 micron filter. The giving set MUST be changed: o o o o At least 12 hourly After every 3 components infused If different ABO groups are given If different components are given If IV set requires priming, then ONLY Normal Saline (Sodium chloride 0.9%) MUST be used. A blood warmer should be used if a large volume transfusion is given in a short time e.g. more than 50mL/ Kg / per hour or 1 unit per 10 minutes in an adult. Blood MUST NOT be warmed by any other means Prior to administration, the component MUST be examined, checked and cross-checked against the Blood Transfusion Chart, Compatibility Label and the ID Band, for the following: The Patient MUST be wearing an ID Band with their correct details printed / written clearly on it. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 19 of 44

20 Full PID check by asking the patient to confirm their name and date of birth and confirming with the information on the ID Band. Identify any red clasps on the ID Band and ensure blood or blood components are not contraindicated. (see Patient Identification Policy) Correct ABO / Rhesus Group. Expiry date of unit on the NHSBT Component Label. (Unless a specific expiry time is stated the component expires at 23:59 on the date shown on the pack label). Check the component label matches any special requirements (CMV Negative / Irradiated) which have been requested by the clinician. Integrity of the pack. Any unusual colour, turbidity (sediment or particles), or clumping of the contents. If there are ANY discrepancies the unit MUST NOT be transfused until the discrepancy has been resolved and the Blood Transfusion Laboratory staff / Transfusion Practitioner contacted for advice. Ensure appropriate care plan is written for the patient Blood Administration Non essential and out of hours / overnight administration of blood components should be avoided wherever possible unless clinically indicated because of the increased risk of errors All checks MUST be performed at the bedside Components issued from the Blood Transfusion Laboratory MUST have a Compatibility Label (see Appendix B1 and / or B2) firmly attached. This MUST carry the following information: Donor unit number and group Surname Forename(s) IW Number Date of Birth Patients Blood Group A peel off copy of the Compatibility Label (see Appendix B1 and / or B2) MUST BE fixed to the Blood Transfusion Chart to ensure full traceability Identification of components and the recipient MUST be carried out by two members of staff, one of whom must be a Medical Practitioner, or holding current registration of the UKCC Professional Register as a Registered Nurse (RGN) / Midwife (RM) / Sick Children s Nurse (RSCN), or Operating Department Practitioner / Assistant and will take responsibility for the checks and sign the Blood Transfusion Chart. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 20 of 44

21 Positive Identification of the patient MUST be carried out before any component is transfused as per the Trust s Patient Identification Policy. Children, patients suffering from dementia, the unconscious or sedated must be identified by the information on their ID Band. The following checks MUST be performed at the bedside: Surname. Forename(s) IW Number Date of Birth Positive identification of the patient must be checked wherever possible, by asking the patient to state their: Full Name (i.e. Surname and Forenames) Date of Birth This MUST be checked and found to be identical with:- Patient s ID Band Blood Transfusion Chart Compatibility Label If there is any discrepancy with the PID it MUST be investigated before the transfusion is commenced The component label and Compatibility Label (Appendix B1 and B2) must be checked to ensure that the expiry date and the reservation date of the unit are valid. The expiry of the unit is at 23:59 on the date shown and the transfusion MUST be concluded by this time The blood group of the component MUST be compatible with that of the patient as indicated on the Compatibility Label. If this is not the case, then the reason for the blood group difference will have been communicated. If no communication has been received then the discrepancy MUST be checked with the Blood Transfusion Laboratory before the transfusion is commenced The donor number on the component label must correspond to that on the Compatibility Label (Appendix B1 and B2). If any discrepancy is found, advice MUST be sought from the Blood Transfusion Laboratory staff / Transfusion Practitioner as to what action should be taken Ensure the chosen IV cannula is patent or, if necessary take appropriate action to ensure patency. If there is going to be a significant delay Components MUST be returned to the Blood Transfusion Laboratory without delay Connect blood administration set fitted with a 200micron filter to intravenous cannula, secure as appropriate Commence the transfusion at the rate prescribed by the Medical Officer or other authorised Health Care Professional on the Blood Transfusion Chart The date and time of commencement MUST be documented on the Blood Transfusion Chart Maintain a full fluid chart and accurately record urine output. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 21 of 44

22 Closely monitor the patient (see Observation of Patient) Immediately AFTER the transfusion is commenced the peel off label on the Compatibility Label MUST be fixed to the Patient s Blood Transfusion Chart Transfusion of each unit of red cells should normally completed within twothree hours of removal from the Issue Fridge or Cold Box, but no longer than maximum of four hours Platelets should be infused over 30 minutes and as soon as possible after removal from the Blood Issue Room FFP should be infused over 30 minutes and within four hours of removal from the Issue Fridge. If the FFP is kept in the Issue Fridge then it can be used up to 24 hours after thawing CRYO should be infused over 30 minutes and within four hours of thawing Observation of Patients Receiving Blood Transfusion For each component given, the following observations must be monitored and recorded on the patients Observation chart (and additionally by entering onto electronic blood tracking software via the handset). Immediately prior to transfusion: Temperature, B/P, Pulse & Respirations (Base Line) After 15 minutes: Temperature, B/P, Pulse & Respirations After 30 minutes: Temperature, B/P, Pulse & Respirations Then hourly (if stable): Temperature, B/P, Pulse & Respirations The patient MUST continue to be monitored for 24 hours after the transfusion every four hours. If the patient is a Day Case then the patient MUST be given advice as to what to be aware of and they MUST be given a contact telephone number where they can obtain advice if they feel unwell after returning home Any change in the observations or if the patient develops pain at drip site, chest pain, back pain, loin pain or a feeling of impending doom etc, must be reported immediately to medical staff. In any case of suspected transfusion reactions, the transfusion must be immediately stopped, medical staff informed and appropriate action initiated Refer to Action to Be Taken in All Cases of a Suspected Transfusion Reaction which appears on the last page of the Blood Transfusion Chart and is also available on the Intranet Completion of Transfusion On completion of the transfusion, the fate of the component MUST be recorded on compatibility label which should be returned to the Blood Transfusion Laboratory as soon as possible (unless the electronic tracking system is in use and the handset used) The giving set should be removed and the intravenous cannula flushed with prescribed normal saline. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 22 of 44

23 Equipment MUST be disposed of safely in accordance with the control of Infection policy (see IPC Safe Handling and Disposal of Sharps). The whole giving set should be discarded in the sharps bin Empty component packs should be sealed with a spigot, placed in a leakproof plastic bag, and disposed as clinical waste by the ward staff Partly used components should not have the giving set removed. They must be placed in a leak-proof plastic container and disposed of as clinical waste by the ward staff If a moderate or severe transfusion reaction is suspected, the component pack and giving set will be required for further investigation. The pack must be sealed with a sterile spigot to maintain sterility and returned to the Blood Transfusion Laboratory immediately in a leak-proof plastic container. This should be sent with a completed Blood Transfusion Reaction Form and appropriate samples as indicated, and should be sealed in a separate plastic bag Recall On occasions there may be the requirement for the recall of red cells, platelets, FFP or CRYO. This may be at the request of NHS Blood & Transplant (NHSBT) or internally by the Blood Transfusion Laboratory in response to further information pertaining to the patient coming to light e.g. special requirements or if an error/ incident is discovered When a recall is indicated it is important that any components that have been produced from that donation are located as soon as possible and that any components not transfused are removed from use. If the component has been transfused then the recipient involved must be identified and appropriate action taken In the event of a recall being instigated the Transfusion Laboratory staff will follow the laboratory recall procedure If the component is in a clinical area or in transit, the Transfusion Laboratory will contact the clinical area and request the immediate return of the unit which MUST NOT be transfused and MUST returned to the Transfusion Laboratory immediately and handed to a member of the Transfusion Laboratory staff If the component is being transfused the transfusion MUST be stopped immediately and taken down. The unit should be sealed with a sterile spigot, returned to the Blood Transfusion Laboratory in a leak proof container and handed to a member of Blood Transfusion Laboratory staff. The episode MUST be recorded on the Blood Transfusion Chart as Part Transfusion together with the amount transfused and annotated product recall If the unit has been transfused in whole or in part, the Transfusion Laboratory will inform the Consultant Haematologist to decide any further action. The clinical area will be informed of any action that needs to be taken. The episode MUST be recorded in the patient s notes and the Blood Transfusion chart relating to the episode MUST be annotated as Product Recall. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 23 of 44

24 8 Consultation 8.1 This document is endorsed by the Hospital Transfusion Team and Hospital Transfusion Committee. 9 Training 9.1 This (Policy for the Transfusion of Blood & Blood Components) has a mandatory training requirement which is detailed in the Trusts mandatory training matrix and is reviewed on a yearly basis 10 Monitoring Compliance and Effectiveness 10.1 Monitoring of the policy is carried out as part of the timed planned programme of audits to ensure compliance The Transfusion Laboratory Manager/ Blood Sciences Quality Manager is responsible for ensuring internal audits are carried out against ISO 15189:2012 / MHRA standards that monitor the transfusion process The Transfusion Practitioner is responsible for conducting National Comparative audits and internal audits in Clinical areas against compliance with the policy All adverse clinical incidents /non-conformances are recorded: Internally: Q Pulse / Datix Externally: SHOT (Serious Hazards of Transfusion) / SABRE (MHRA) 10.5 All adverse clinical incidents /non-conformances are fully investigated, the outcome recorded and Corrective and Preventative Action (CAPA) put in place 10.6 The HTT is responsible for reviewing serious adverse events and reactions, including near misses and reporting findings to the HTC The HTC is responsible for reviewing serious adverse events and reactions, including near misses as referred by the HTT and reporting to the Trust board The Transfusion Practitioner is responsible for monitoring the electronic blood tracking system to identify operator errors in the transfusion process in Clinical areas, to investigate any errors and put effective CAPA in place The Training & Development Department is responsible for maintaining records of any Safe Transfusion Practice training carried out as part of the Trust s Mandatory Training programme Ward / Clinical Department managers are responsible for recording and maintaining records of staff within their area in regard to attendance of Safe Transfusion Practice Training and NPSA Competency Assessments. POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 24 of 44

25 11 Links to other Organisational Documents Aseptic Non Touch Technique (ANTT Policy) cy.pdf Maximum Surgical Blood Ordering Schedule Patient Identification Policy Safe Handling and Disposal of Sharps y.pdf Training Tracker: Blood Transfusion Safe Transfusion Practice Level 1 (Mandatory for all Clinical Staff) Blood Transfusion Level 2: Modules 1, 2 & 3) B. Braun Infusomat Infusion Pump (Blood Use Only) Consent Process - An Introduction 12 References Association of Anaesthetists of Great Britain and Ireland Blood Transfusion and the Anaesthetist; Red Cell Transfusion 2. British Committee for Standards in Haematology; Guidelines for the Administration of Blood Components. December 2009 British Committee for Standards in Haematology; Guidelines for pre-transfusion Compatibility in Blood Transfusion Laboratories. Transfusion Medicine, 2012, 23, 1, British Committee for Standards in Haematology: Guidelines for the Clinical Use of Red Cell Transfusions. British Journal of Haematology, British Committee for Standards in Haematology: Guidelines for the use of fresh frozen plasma, Cryoprecipitate and Cryosupernatant. British Journal of Haematology 2004, Vol126 1 British Committee for Standards in Haematology: Amendment to the guidelines for the use of fresh frozen plasma, Cryoprecipitate and Cryosupernatant (selection according to ABO and RhD grouping.) 2005 BCSH Transfusion Task Force. British Committee for Standards in Haematology: Guidelines for the Use of Platelet Transfusions. British Journal of Haematology, , 1 EU Commission Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC (Blood Safety and Quality Regulations) POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 25 of 44

26 Norfolk D Handbook of Transfusion Medicine 5 th Ed. UK Blood Services London TSO The Blood Safety and Quality Regulations. Statutory Instrument 2005 No. 50 and addition amendments. 13 Appendices Appendix A NHSBT Label Appendix B1 Blood Compatibility Label Appendix B2 Electronic Blood Compatibility Label Appendix C Appendix D Appendix E Appendix F Appendix G Appendix H Appendix I Requesting Components in an Urgent Situation Investigations of Moderate or Severe Acute Transfusion Reactions Guidelines Jehovah s Witnesses & Blood Transfusion Blood Transfusion Crossmatch Request Form Blood Collection Slip Financial and Resourcing Impact Assessment on Policy Implementation Equality Impact Assessment (EIA) Screening Tool POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 26 of 44

27 NHSBT Label Appendix A Donation Number ABO / RhD Group Product Code Expiry Date Irradiated Product Label Only present if product irradiated when indicator turns black CMV NEG Additional Information e.g. CMV status etc POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 27 of 44

28 Isle of Wight NHS Primary Care Trust St Mary s Hospital Blood Compatibility Label Appendix B1 THIS LABEL IS ATTACHED TO THE BLOOD OR BLOOD COMPONENT PACK IT IS A LEGAL REQUIREMENT TO CONFIRM THE FATE OF THIS UNIT Unit No. Product Surname Forenames IW Hosp No DOB Ward Reserved until 9am Group Group Patients S U I T A B L E Unit No. Product Surname Forenames IW Hosp No DOB STOP! Before transfusion read the information on the reverse Ward Reserved until 9am Group Group Patients This tear off portion is to be fully completed and returned to the Blood Transfusion Laboratory as soon as possible I confirm that the above unit Transfused (all or part) to the above named patient Returned to the laboratory out of temperature control Disposed as pack damaged Print Name. Signature. Date Time F O R P A T I E N T Unit No. Product Surname Forenames IW Hosp No DOB Ward Reserved until 9am Patients Group Group Attach this peal off label to the Blood Transfusion Chart This Peel Off Sticker is to be affixed to the Blood Transfusion Chart Before Transfusion Carry out these checks Isle of Wight NHS Primary Care Trust St Mary s Hospital Ask the patient to state their name and date of birth. Check these details and the patients hospital number match the wristband and this label attached to the unit. This information must match the patients wristband No wristband No Transfusion Check the unit numbers is the same on the unit and this label. If any details do not match, contact the Blood Transfusion Laboratory Do Not Transfuse If a transfusion reaction is suspected STOP the transfusion Seek medical advice BLOOD SAFETY & QUALITY REGULATIONS 2005 IMPORTANT It is a legal requirement to complete the tear off section overleaf and return it to the Blood Transfusion Laboratory For Laboratory use only Fate of unit entered on Laboratory computer Incident form completed for this unit POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 28 of 44

29 Electronic Blood Compatibility Label Appendix B2 THIS LABEL IS ATTACHED TO THE BLOOD OR BLOOD COMPONENT PACK 2D Barcode Label This Peel Off Sticker is to be affixed to the Blood Transfusion Chart POLICY FOR THE TRANSFUSION OF BLOOD AND BLOOD COMPONENTS Page 29 of 44