New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing › Section 58-2.27 - Reinfusion procedures

Current through Register Vol. 46, No. 28, July 10, 2024
(a) All
					 entities performing reinfusion procedures or any part thereof shall hold a
					 valid department permit in the category of blood services "" transfusion or be
					 approved by the department as a limited reinfusion service. Such limited
					 reinfusion services are subject to inspection by the department.
(b) All reinfusion procedures shall comply
					 with written protocols approved by the director of transfusion services and the
					 transfusion committee of the facility where the reinfusion is to be performed,
					 the director of the hospital department where the product is reinfused, and the
					 hospital department or facility where processing for the reinfusion procedure
					 is performed, if different. These protocols shall include procedures for
					 collection, labeling, handling, processing and reinfusion of the product. All
					 reinfusion procedures performed in hospitals shall be reviewed by the hospital
					 transfusion committee.
(c) The
					 syringe, tube, bag, or other container into which the blood or component
					 thereof is collected for reinfusion, shall be labeled at the time of collection
					 with two forms of identification, one of which shall be the patient's name. The
					 person drawing the blood or component shall initial or sign the records
					 pertaining to the collection and certify that the identification on the blood
					 or component and on the pertinent records is correct.
(d) During shipment, processing and storage,
					 reinfusion products shall be maintained at a temperature between one and 38
					 degrees Celsius, except as otherwise required in a protocol approved by the
					 director of the service performing the reinfusion. Red cell reinfusion products
					 shall not be exposed to a temperature above six degrees Celsius for more than
					 six hours. While in transit, the container and shipping box for such products
					 shall be appropriately labeled as containing human blood products.
(e) Any container into which the blood or
					 component is transferred from another container during reinfusion processing
					 shall be labeled prior to the transfer with two forms of identification, one of
					 which shall be the patient's name or identification code. The person performing
					 the transfer shall initial or sign the records pertaining to reinfusion
					 processing of the blood or component and shall certify that the container
					 identification was transcribed correctly. All final containers shall be labeled
					 with the patient's name, description of the contents, expiration date and
					 dosage, if applicable.
(f) No
					 reinfusion of a processed product shall be performed unless two individuals
					 other than the patient have confirmed the identity of the recipient and the
					 product to be reinfused as matching in name and in at least one additional
					 identifier. This confirmation shall be documented in writing.
(g) All errors or accidents during processing
					 or reinfusion procedures, that may pose a substantial risk to the patient shall
					 be reported to the department's Wadsworth Center, with sufficient detail to
					 facilitate evaluation and investigation, within seven calendar days of the
					 error or accident, or its discovery.
(h) All records pertaining to reinfusion
					 procedures shall be retained for a minimum of seven years.