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 58-2.3 - Required laboratory tests for donated blood

Current through Register Vol. 46, No. 28, July 10, 2024
(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 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
					 allogenic 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 physician 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.