Section 140.380 - Procurement, Storage and Administration of BloodEach clinic that administers human whole blood and/or its components and/or derivatives in transfusion shall meet the following requirements:
(A) The clinic shall have a current, effective agreement with a blood bank licensed by the Department that meets the requirements of 105 CMR 135.000: Use of Blood, Blood Components, and Derivatives for the Purpose of Transfusion.(B) The clinic shall obtain blood from a licensed blood bank immediately prior to its administration. All blood so obtained shall be identified, stored, handled, and administered in accordance with the requirements of 105 CMR 135.000: Use of Blood, Blood Components, and Derivatives for the Purpose of Transfusion.(C) The clinic shall develop policies and procedures specific to all aspects of the procurement, storage and administration of blood. These policies and procedures at a minimum shall address patient selection and consent, the requirements for explicit written order(s) from a physician, nurse practitioner, or physician assistant the prompt availability of physicians in the event of an emergency, the proper identification of the patient, the qualifications and training of the registered nurse administering the blood, the monitoring of patients undergoing transfusion, including the required observation time following administration, procedures to follow in the event of a transfusion reaction and recordkeeping requirements.(D) Prior to the initiation of a program to procure, store and administer blood for transfusion, each clinic shall inform the Department in writing and receive Department approval. Department approval shall be based on compliance with 105 CMR 140.380(A), (B) and (C) and other relevant clinic licensure regulations.(E) Except as provided for in 105 CMR 140.614, transfusion of blood shall not be permitted as part of the surgical service of a clinic.Amended by Mass Register Issue 1443, eff. 5/14/2021.