Title: Section 58-2.27 - Reinfusion procedures

Effective Date

09/27/2015

58-2.27 Reinfusion procedures.

(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 (7) 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.
 

Volume

VOLUME A-1 (Title 10)

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