Sec. 58-8.2. HIV testing and recordkeeping requirements

In addition to other applicable requirements in this Part, and Parts 52 and 63 of this Title, clinical laboratories, blood banks and tissue banks with a New York State clinical laboratory permit to perform HIV testing shall meet the following requirements:

(a) Specimens for testing patients, donors and insurance applicants shall be only of the type approved by the FDA or acceptable to the department for use with the particular method or test kit.

(b) All tests shall employ reagents, methods, techniques and procedures approved by the FDA or acceptable to the department in conformance with generally accepted laboratory principles.

(c) If the test result is to be communicated to the test subject or other person legally authorized to receive the result, results for specimens found reactive in accordance with the test manufacturer's interpretation of HIV antibody screening test results shall be confirmed with HIV confirmatory testing.

(d) Confirmatory testing shall be performed as soon as practicable in all cases when notification of a preliminary finding of HIV infection is made.

(e) A standard operating procedure manual (SOPM) shall be developed and maintained current, and shall include, in addition to documentation required elsewhere in this Part and Part 52 of this Title, algorithms for use of each HIV test method or test kit, and policies and processes for accepting specimens, reporting results, and ensuring compliance with confidentiality requirements and, as applicable, reporting requirements of article 21, title III and article 27-F of the Public Health Law and New York State Insurance Law, section 2611(c).