All institutions that transfuse blood components and products should implement national and local policies and written procedures for:

Transcription

1 5.0 GENERAL GUIDE TO GOOD TRANSFUSION PRACTICE Blood and the various components prepared or manufactured from it are biologic (in the case of blood cells, living human tissues) products intended for use by medical practitioners in the care of their patients. Blood component therapy has had a central role in the advances and practice of modern medicine but should be viewed in a similar light to other risk/benefit decisions in clinical medicine. Professional judgement based on clinical evaluation determines selection of components, dosages, rate of administration and decisions in situations not covered in this general introduction to blood transfusion practice. The presence of contaminants, immunogenic cellular and protein elements, viable donor cells and infectious agents in blood and blood products that may cause undesirable side effects in some recipients, cannot be totally avoided. The information in this booklet, therefore, cannot be considered or interpreted as an expressed or implied warranty of the safety or fitness of the described blood component or blood product when used for their intended purpose. 5.1 Clinical Governance A quality management system is needed wherever blood component therapy is given. Quality includes adequate documentation in both the transfusion process and outcomes. All institutions that transfuse blood components and products should implement national and local policies and written procedures for: Documentation of transfusion. Requests for blood transfusion. Collection of blood samples for pretransfusion compatibility testing. Collection of blood components from the hospital blood bank or other sites. Delivery of blood components to where the transfusion is to be given. Administration of blood components and products. The care and monitoring of patients receiving a transfusion. The management and reporting of adverse events. Staff responsibilities and the training required for these procedures. Page 18 New Zealand Transfusion Medicine Handbook 2003

2 5.2 Prescribing Blood Components and Products: a Checklist for Clinicians A Medical Practitioner must prescribe the order for the transfusion of blood components or blood products. The only exception is the prescription of Anti-RhD immunoglobulin by midwives. Decisions should be based on the NHMRC/ANZSBT Clinical Practice Guidelines for the Use of Blood Components, taking individual patient needs into account. The following mental checklist should be used before you make a decision to transfuse a patient: What improvement in the patient s condition am I aiming to achieve? Can I minimise blood loss to reduce the patient s need for transfusion? Are there any other treatments I should give before making the decision to transfuse? Has cross-matching and any other relevant test been carried out? What are the specific or laboratory indications for the transfusion of the blood component or product for this patient? What are the risks of transmitting infectious agents through the available blood components and blood products? It should also be born in mind that the rate of noninfectious complications is probably higher than infectious complications. Do the benefits of transfusion outweigh the risks to this particular patient? Will a trained person monitor this patient and respond immediately if any acute transfusion reactions occur? Have I recorded my decision to transfuse and the reasons for transfusion on the patient s chart and any documentation used in the ordering or administration of blood components? Has the patient been given a clear explanation of the potential risks and benefits of blood component therapy in his or her particular case? New Zealand Transfusion Medicine Handbook 2003 Page 19

3 5.3 Documentation of Transfusions Recording of the blood component number and the blood product batch number for each and every unit transfused into a patient (or discarded) is essential for the effective investigation of adverse reactions, in particular, those caused by infectious diseases following the transfusion of a blood component or blood product. The following are recommended: The prescribing doctor should document the transfusion decision (based on recognised clinical practice guidelines) in the medical record. There must be documentation of the patient s informed consent. The prescription must be documented by the doctor who must specify the blood component or product to be administered, the quantity, the rate of infusion and any other special requirements. A permanent record of the transfusion should be kept in the patient s medical record, it should include: - The sheets used for the prescription of the blood component or product. - Where appropriate, the blood transfusion compatibility report form. - Nursing observations during the transfusion. - Indication for the use of the blood component or product, the date, the number and type of components or products (including the donation/batch numbers), whether or not the desired effect was achieved and the recording of the management of any adverse event. All records, as a requirement of legislation, must be held for 20 years. 4 The majority of transfusion errors are of a clerical nature: - Failure to identify the recipient when blood is taken for matching. - Failure to correctly label the recipients blood sample. - Transcription errors in the laboratory. - Failure to identify clearly the recipient prior to the setting up of the transfusion. - Failure to positively establish that the blood about to be transfused has in fact been matched for that patient. 4 ANZSBT Guidelines for Pretransfusion Testing, 4th Edition, 2002 and National Pathology Accreditation Advisory Council 1998 Page 20 New Zealand Transfusion Medicine Handbook 2003

4 5.4 Informed Consent by Patients to Receive a Transfusion 5 Patients or their relatives may be worried about the risks of transfusion. Some will seek and require quite detailed reasons for the transfusion, the risks involved and the alternatives, available to them (such as autologous transfusion). Some patients may refuse transfusion with blood, (for example members of the Jehovah s Witness faith are strictly banned by their religious beliefs from receiving a blood transfusion). Some of these patients may be prepared to accept plasma fractions or other alternatives. Informed consent for transfusion is a requirement of the New Zealand Code of Health and Disability Services Consumers Rights Code. This requires that patients be provided with information and an explanation of the purpose for which blood components and blood products are being prescribed and that they consent to transfusion. This process, together with the reasons for the transfusion, should be recorded in the case notes of the patient. NZBS produces a range of leaflets to support the process of gaining informed consent. Copies of these should be available in all sites where blood may be transfused. Copies can be obtained from your local Blood Centre. 5.5 Requesting Blood Components and Products Completing the blood request form accurately and legibly is an important step in ensuring that the right quantity and type of blood component or product is made available to the right patient at the right time in the right place. A NZBS request form providing the essential requirements for ordering blood components and products is made available throughout New Zealand. However, this form is not used in all hospitals. It is the responsibility of the doctor, or in the case of Anti-RhD immunoglobulin a registered midwife, to prescribe blood components and products. Full and accurate completion of this form is essential for reducing the risk of error of identification and the possible side effects from antibodies associated with previous transfusions or pregnancy. In the event that it is known that the patient has a blood group antibody, alerting the blood bank as early as possible assists in providing suitably matched blood when required. Patients who at the time of admission cannot be reliably identified must be given an identity band with a unique number. This number must be used to identify this patient until full and correct details are available and are properly communicated to the Blood Bank. 5 Clause 6. of the regulation known as the Code of Health and Disability Services Consumers Right, 1998, which is administered by the Health and Disability Commissioner. New Zealand Transfusion Medicine Handbook 2003 Page 21

5 Requesting Blood Components and Products cont. The request form MUST contain essential details of patient information, previous transfusion history and indicate the quantity of blood component or product and when it is required. The NHMRC Guidelines for guidelines for transfusion of blood components will be found on the reverse of the NZBS request form. 5.6 Blood Samples for Compatibility Testing Correctly identifying the patient both before the collection of the pretransfusion sample and before starting the transfusion is vital in avoiding wrong blood episodes. At the time of taking the sample the conscious patient must be asked to state his or her first name, family name and date of birth. This information must be checked against the patient s identification bracelet to make sure that the details entered on the request form are identical. The blood sample should be collected according to the hospital laboratory manual and into the correct sample tube. The sample tubes must be accurately labelled at the bedside of the patient at the time the blood is collected from the patient. Sample tubes must not be pre-labelled before the blood sample is obtained because of the risk of putting the patient s blood into the wrong tubes. In the case of an unconscious patient a medical practitioner should complete the request form, take the blood sample and label the sample tube. 5.7 Pretransfusion Testing Pretransfusion compatibility testing prior to possible red cell transfusion is extremely important. A Group and Screen may be variably referred to as group and hold or group and save or type and screen. The laboratory, is required to: Determine the ABO and RhD group of the recipient. Page 22 New Zealand Transfusion Medicine Handbook 2003

6 Perform an antibody screen on the serum of the recipient. Check for previous or duplicate records, and compare current results with historical findings when these are available. Select appropriate donor blood. When a blood component is required for transfusion the patient details can be matched against the details of grouped and screened donor components held in the blood bank. Various approaches exist for the final compatibility check in the laboratory. This may involve a formal crossmatch of the patients serum with the donor red cells or in some hospitals an electronic cross-match approach is used. Once the crossmatch procedure is completed the blood can be immediately issued to the ward or operating theatre. 5.8 The 72 Hour Rule Blood group antibodies may appear very rapidly in response to an immunologic stimulus to transfused donor red cells. When more than 72 hours has elapsed from the time of the group and screen a further blood sample is requested from the patient. (This is especially important if there has been a transfusion completed more than 24 hours since the previous crossmatch). The 72 hour rule will also apply whenever a patient has been transfused red cells, platelets, is pregnant or has been pregnant within the last 3 months. In some instances a longer period may be allowed for some patient specimens. When in doubt the local Blood Bank should be contacted for advice. 5.9 Crossmatching Problems If a clinically significant antibody is detected in the patient s serum on the antibody screen the relevant phenotype negative donor blood has to be identified and matched against the patient s serum. This is a time consuming process but necessary if the patient is to receive compatible blood. If there is insufficient time for the full identification of the antibody(s), the patient s serum is matched against random red cell units until a compatible, or least incompatible, unit is found. In these circumstances there should be discussion with a Transfusion Medicine Specialist to ensure that the risk of delaying transfusion is balanced against the risk to a patient s life of transfusing the least incompatible crossmatched blood or group specific blood. New Zealand Transfusion Medicine Handbook 2003 Page 23

7 5.10 Maximal Blood Order Schedule The available shelf life of a unit of red cells decreases each time the red cell unit is held or cross matched for a patient who does not use it. When more blood is ordered than is required, it is unavailable for other patients and increases the chance that the blood will expire before it is used. Providing crossmatch guidelines such as a group and screen policy, a maximal blood order schedule (MBOS) and monitoring crossmatchtotransfusion (C/T) ratios is helpful in preventing blood expiring unnecessarily. The MBOS defines the number of units needed to meet the needs of 80 90% of patients undergoing a specific procedure and assists in ordering the appropriate number of units. The transfusion service, however, must give special consideration to patients with a positive antibody screen. Many laboratories also formulate a MBOS based on local surgical experience Administration and Observation of Transfusion 5.12 Storage All transfusions should be performed and monitored in accordance with hospital policies and guidelines. Before transfusion, always confirm the identity of the recipient and the unit, as well as the expiry date. All blood components should be infused within four hours of issue from the blood bank or storage in a monitored refrigerator approved for the purpose of storing blood. Never store blood components in a standard ward refrigerator. If the transfusion cannot be started immediately, return the unit to the blood bank for appropriate storage Rate of Infusion and Precautions The appropriate rate of transfusion may vary significantly according to the clinical circumstances. Patients who are actively bleeding and/or are in hypovolaemic shock will require blood to be transfused as rapidly as possible. Patients with cardiac failure are at risk of circulatory overload and it is necessary to transfuse slowly and cautiously. Page 24 New Zealand Transfusion Medicine Handbook 2003

8 5.14 Filters For infusions of intravenous immunoglobulin (Intragam P) there are specific protocols recommending the rate of infusion. Instructions relating to the administration of other manufactured plasma derivatives accompany the issue of every product. Advice must be sought from the doctor looking after the patient if there is any doubt about the way or how rapidly a blood component or product should be transfused. Standard blood giving sets include a micron filter and must be used for the administration of all blood components. The filter will remove any aggregated material and fibrin clots. It is good practice to change giving sets after 3-4 units or every 12 hours. In New Zealand, leucocyte-depleting filters are NOT required during the administration of blood components due to universal leucodepletion of blood during processing. Caution! Do NOT use leucocyte-depleting filters for Granulocyte Concentrates or Donor Lymphocyte infusions. If there is doubt about the appropriateness of filters or their use contact the Blood Bank, a Transfusion Medical Specialist or Clinical Haematologist CMV Although current evidence indicates that effective prestorage leucodepletion, such as undertaken by NZBS, may be as effective as CMV antibody screening in reducing the risk of CMV transmission, serologically antibody negative CMV components are made available when a heightened risk of CMV exists. The circumstances in which this occurs include: - CMV negative allograft recipients receiving a CMV antibody negative graft. - CMV antibody negative autograft recipients. - CMV antibody negative acute leukaemia patients prior to transplant. - All new patients with a haematological malignancy until their CMV antibody status is known. - HIV antibody positive patients who are CMV antibody negative. - Intrauterine and neonatal exchange transfusions. - Transfusions to premature infants of a CMV antibody negative mother. New Zealand Transfusion Medicine Handbook 2003 Page 25

9 5.16 Irradiation Cellular components must be irradiated to avoid transfusion induced graft versus host disease when clinically appropriate. Definite Indications for Irradiation: Allogeneic and autologous bone marrow/pbsc transplant recipients. Patients with aplastic anaemia receiving immunosuppressive therapy. Hodgkin s Disease. Cellular components derived from near genetic relatives of the recipient. Intrauterine and all subsequent transfusions and neonatal exchange transfusions. Congenital cellular immunodeficiency disorders. HLA matched single donor platelets. Patients receiving purine analogues with associated immunosuppression. Granulocyte transfusions. Possible Indications for Irradiation: Premature/very low birth weight infants, less than 1500g. Lymphoid malignancies. - T cell malignancies. - Patients with B cell malignancy who receive chemotherapy and/or radiotherapy leading to a lymphopenia of less than 0.5 x 10 6 /L. - Patients receiving therapeutic antibodies against T cells. Non lymphoid malignancies. - Acute leukaemia. - Chronic myelocytic leukaemia. - Any patients who receive chemotherapy and/or radiotherapy leading to a lymphopenia of less than 0.5 x 10 6 /L. - Patients receiving long term or high dose corticosteroids as therapy for their malignancy. Page 26 New Zealand Transfusion Medicine Handbook 2003

10 No Indication on Present Reporting for Irradiation: Acquired Immune Deficiency Syndrome where none of the above apply. Congenital humoral deficiency disorders. Term infants where none of the above apply. Thalassaemias. Haemophilia Medication 5.18 Warming 5.19 Pumps Caution! Do NOT add medication to units/containers of any blood component or product unless specifically approved. If there is any doubt concerning any material that is to be added to a blood component or product, contact a Transfusion Medical Specialist or Clinical Haematologist. If warming is required, an appropriate approved and monitored system must be used. Blood and blood components must NOT be warmed above 41 C. Approved infusion pump devices may be used to assist transfusion. Caution! Haemolysis of red cells may occur with some models. Check the manufacturer s instructions before the use of red cells and platelet concentrates Compatible Intravenous Solutions Use only 0.9% NaCl injection BP. Do NOT use 5% Dextrose solutions, which may induce haemolysis. Do NOT use Lactated Ringer s solution or Haemaccel. These contain calcium, which may induce clot formation in the blood bag and/or administration set Local systems and Procedures If you are not familiar with the local requirements for obtaining blood components and products, visit the blood bank. The clinical and technical staff will be able to explain the system. There is no substitute for talking with people who are working to help you care for your patients. New Zealand Transfusion Medicine Handbook 2003 Page 27