QSA.05.01.01: The laboratory has written policies and procedures for the blood transfusion service. 1. The laboratory has written policies and procedures for the blood transfusion service. 2. The policies and procedures for the blood transfusion service are current and revised whenever standards of practice change. 3. The policies and procedures for the blood transfusion service are available to staff involved in transfusion service. 4. The blood transfusion service director or an individual qualified as a technical supervisor in immunohematology conducts a review of the policies and procedures of the blood transfusion service every two years. The review is documented. 5. The transfusion service director has oversight of policies, processes, and procedures related to the blood transfusion service, including blood administration. 6. The laboratory's writtent policies and procedures for administration of outpatient transfusions include instructions for monitoring adverse patient reactions after release from direct medical observation. 7. The transfusion service obtains written documentation of approval from the medical director when clinical situations warrant an exception to policies, processes, or procedures. 8. The laboratory follows its policies and procedures for the blood transfusion service. 9. The policies and procedures for the blood transfusion service define the staff responsible for the provision of blood, blood components, tissue, derivatives, and services.