N.Y. Comp. Codes R. & Regs. tit. 10 § 58-2.12

Current through Register Vol. 46, No. 25, June 18, 2024

Section 58-2.12 - Records to be kept when blood, blood components or derivatives are issued for allogeneic or autogeneic transfusion

(a) For blood and blood components, records of the following information, as applicable, shall be kept in the blood bank and made available to the department for inspection:

(1) source;

(2) unit identification code upon receipt and, if different, upon issuance;

(3) unit ABO and Rh groups;

(4) expiration date;

(5) results of all pretransfusion testing;

(6) disposition of the unit, including remote storage location, if any, and intended recipient's name or, if the name is unknown, identification code;

(7) identification of the station code or person taking possession of the unit;

(8) documentation of visual inspection;

(9) date and time of issuance; and

(10) results of all tests associated with the investigation of all transfusion reactions, with the conclusions reached and the report signed, or approved by electronic equivalent, by the director of the blood bank or a qualified physician designated by the director of the blood bank.

(b) For coagulation factor concentrates, logbook records of the following information shall be kept and made available to the department for inspection:

(1) manufacturer;

(2) lot number;

(3) expiration date;

(4) disposition, including recipient's name if administered; and

(5) date of issue.

(c) For all derivatives, records associated with the investigation of all reactions, with the conclusions reached and the report signed, or approved by electronic equivalent, by the director of the blood bank or a qualified physician designated by the director of the blood bank, shall be kept and made available to the department for inspection.

(d) These recordkeeping requirements shall also apply to blood components issued to limited transfusion services and to blood components issued to ambulance transfusion services.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 58-2.12

Amended New York State Register July 29, 2015/Volume XXXVII, Issue 30, eff.9/27/2015