Title: Section 58-2.3 - Required laboratory tests for donated blood

58-2.3 Required laboratory tests for donated blood.

(a) For allogeneic collections under New York State permit, approved tests for syphilis; hepatitis B surface antigen (HBsAg); HIV-1 and hepatitis C virus (HCV) nucleic acid; and antibodies to hepatitis B core antigen (anti-HBc), HCV, HIV-1, HIV-2, and human T-lymphotropic virus types I and II (HTLV-I/II) shall be performed in a New York State-permitted laboratory. For autogeneic collections, such testing shall be performed unless the blood is intended for transfusion at the same facility where it is collected and a system is in place to ensure correct disposition of each blood unit, but the testing need not be performed again if already performed within the previous 30 days or if performed on a specimen collected subsequently. Results of a given test run shall not be accepted and reported if results of test kit controls are outside of the predetermined acceptable range. A written report shall be received thereon prior to the release of blood or blood components for transfusion and, if serologic tests are positive, shall preclude release for allogeneic transfusion except as described in section 58-2.9(b) of this Subpart. Until such testing is completed, all blood and blood components shall be stored in a separate refrigerator or prominently labeled separate area of the refrigerator reserved for quarantined units. However, in an emergency requiring release for transfusion prior to receipt of such report, the results shall be recorded subsequently on the recipient’s chart. Any unacceptable blood unit identified, as well as all of its components, shall be removed immediately from the quarantine area and disposed of or moved to a separate area reserved for such units. Units unacceptable for transfusion, which are retained for other purposes, shall be labeled with pertinent test results.

(b) All test runs for required tests for infectious disease markers that generate numeric readings shall include a weakly reactive control . If the results of this weakly reactive control or any other control do not fall within the predetermined acceptable range, results from that run shall not be reported until the run is repeated. Results of all tests shall be verified by a second staff member to preclude errors in transcription or interpretation. In a manual system, examination of the original instrument tape shall be conducted by the second staff member. Except for results of tests performed on samples from autogeneic donors, as specified in section 58-2.23 of this Subpart, incomplete test results shall not be reported to donors, including any initially reactive test results not yet repeated in duplicate. Release of blood units from quarantine shall be based on examination of a signed and verified hard copy, or electronic equivalent, of all test results. The director of the laboratory conducting the testing shall be responsible for ensuring that testing is performed in accordance with this Subpart. The blood bank director shall be responsible for development of algorithms for test result interpretation and shall approve, in writing, the laboratory procedures to be used.

(c) Plasma collected for fractionation purposes only need not be tested for HTLV-I .
(d) If platelets are donated by the infant's mother to an infant with alloimmune neonatal thrombocytopenia, the donor's blood need not be tested as required in subdivision (a) of this section. In such case, the donor requirements specified in section 58-2.2 of this Subpart may also be waived with the written authorization of the medical director of the blood bank or physican designee.
(e) If multiple patient-dedicated blood components are donated by a single donor to support a particular patient, that donor's blood may be screened for all analytes specified in subdivision (a) of this section every 30 days, rather than at each donation. If the clinically useful shelf life of a blood component precludes completion of the required testing prior to component expiration, screening for all analytes specified in subdivision (a) of this section may be performed on a donor blood specimen collected prior to the donation, as permitted by the F.D.A.
(f) For both allogeneic and autogeneic collection, the ABO and Rh groups of every donor shall be determined in accordance with procedures approved by the department. The determination shall be made by:
(1) testing the blood cells with anti-A and anti-B grouping sera; testing the serum or plasma from the blood with known group A and group B red blood cells; and
(2) testing the blood with anti-Rh(o) (anti-D) grouping serum, including, in the case of initially negative testing with anti-Rho (anti-D), a method designed to detect weak D.

(g) For allogeneic collection, required tests for detecting unexpected alloantibodies:
(1) All donor blood shall be tested for unexpected alloantibodies using reagent red blood cells that meet F.D.A. standards and are intended for this purpose.
(2) Methods of testing for alloantibodies shall be those that demonstrate sensitizing and hemolytic antibodies.
(h) Errors or accidents in collecting, testing or processing of donor blood that are not detected prior to distribution and that may affect the safety of any product or health of the donor or recipient shall be reported to the department's Wadsworth Center within seven (7) calendar days of such an error or its discovery and, if required, to federal authorities.