Waiver of Requirements Imposed on Blood Banks and Transfusion Services

(A) The Commissioner maywaive the applicability to a particular blood bank or transfusion service of one or more of the requirements imposed on that blood bank or transfusion service by 105 CMR 135.000 if the Commissioner finds that: (1) compliance would cause undue hardship; and (2) the blood bank or transfusion service is in substantial compliance with the spirit of the requirement; and (3) the blood bank's or transfusion service's non-compliance does not adversely affect the quality of the blood bank. (B) The blood bank or transfusion service shall provide to the Commissioner or his/her designee written documentation supporting its request for a waiver. A transfusion shall be performed only by: (A) A physician; or (B) A registered nurse, registered by the Board of Registration in Nursing under M.G.L. c. 112, § 74, who is specially trained for this duty, provided that a physician shall be available within 15 minutes to respond to any adverse reaction to the transfusion by the recipient. (C) Other personnel, approved by the health care facility, who are specially trained for this duty, provided that a physician shall be available within 15 minutes to respond to any adverse reaction to the transfusion by the recipient.