§ 13.05 — Testing for Tuberculosis

§ 13.05 Testing for Tuberculosis.

A clinical laboratory authorized to perform tests for tuberculosis, including the growth of cultures from clinical specimens for the isolation of mycobacteria, shall adhere to the following minimum requirements: (a) Within 24 hours of observing growth of a culture or subculture of M. tuberculosis complex, a portion of the initial culture or subculture from any specimen from which M. tuberculosis complex has been isolated shall be submitted to the Department for DNA or other molecular analysis. (1) A laboratory which submits a specimen to the Department for drug susceptibility testing shall be deemed to have complied with subdivision (a) of this section unless otherwise notified by the Department. (2) The Department's records relating to such DNA analysis shall be confidential in accordance with 24 RCNY Health Code § 11.11. (b) 1) Smears performed to detect acid fast bacilli (AFB) shall be examined within 24 hours after receipt of the specimen in the laboratory, and when concentrated smears for AFB are performed on clinical specimens (e.g., sputum) all positive results shall be reported to the Department. Negative smears shall be reported to the physician or other person authorized to request laboratory tests, or the forwarding laboratory, if any, within 24 hours pursuant to 24 RCNY Health Code § 13.05(b)(7) and must also be reported to the Department if the smear is from a patient who, within the last year, was previously reported with a positive AFB smear. All respiratory specimens which test acid-fast smear positive and are from patients who have not previously been diagnosed with tuberculosis shall have nucleic acid amplification testing performed. If a laboratory examining the specimen does not have the ability to perform nucleic acid amplification testing, it shall submit an appropriate specimen to the Department for testing by the Department of a laboratory designated by the Department. (2) Conventional cultures of clinical specimens shall be initiated within 24 hours after receipt, shall be examined for growth at least once each week after inoculation and, upon observing adequate suspicious growth, an acid fast smear examination shall be performed. Identification of M. tuberculosis complex shall be completed within four (4) working days after adequate suspicious growth is first observed; and (3) Cultures of clinical specimens shall be completed within fifteen (15) working days after growth is first indicated. Identification of M. tuberculosis complex shall be completed within four (4) working days after adequate suspicious growth is first observed; and (4) If direct drug susceptibility testing is performed it shall be initiated within 24 hours or the next scheduled workday after obtaining a smear positive for acid fast bacilli, and, if indirect drug susceptibility testing of pure cultures is performed, it shall be initiated as soon as growth typical of M. tuberculosis is observed; and (5) If the time periods provided in paragraphs 1 through 4 above cannot be adhered to by the receiving laboratory, then specimens shall be forwarded to another clinical laboratory within 24 hours after receipt of a specimen; and (6) For other laboratory techniques and methodologies, examination schedules recommended by the manufacturer of each such methodology shall be adhered to; and (7) The result of any test or examination related to tuberculosis including but not limited to those specified in this section shall be reported to the physician or other person authorized to request clinical laboratory tests, or the forwarding laboratory, if any, within 24 hours of the test result or finding. (8) A negative result of any laboratory test or examination related to tuberculosis must also be reported to the Department within 24 hours of the test result being known if the test is conducted on a specimen from a patient with any prior positive laboratory test related to tuberculosis on any sample collected within one year.