Transfusion Outside of a Licensed Hospital

(A) No transfusion shall be performed outside of a transfusion service within a licensed hospital unless the blood products are obtained through an agreement with a blood bank governed by 105 CMR 135.000 and are administered in one of the following circumstances: (1) In an out-patient kidney dialysis facility licensed under 105 CMR 145.000 for dialysis-related purposes. (2) In dialysis-related treatment of a home dialysis patient, providing there is documentation that the dialysis helper has been adequately trained in transfusion practices and precautions. (3) In the home treatment of hemophilia. (4) In other unusual circumstances, to protect patient health or safety, as deemed necessary by a blood bank director, providing that: (a) the blood bank director reviews and approves the procedures being used to accomplish the transfusion; and (b) the physicianorderingthe transfusion is responsible for the administration of the blood or blood product to the patient. (5) In a health care facility or service setting (other than a hospital) licensed by the Department, under agreement witha blood bank and if authorized by the relevant health care facility or service setting licensure regulations. (B) The transport and transfusion of blood or blood products in accordance with 106 CMR 135.410(A) shall be performed in accordance with 105 CMR 135.000 and if, in addition, informed consent is obtained from the patient.