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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.
(a) All clinical laboratories, as defined under 24 RCNY Health Code § 13.01, that report laboratory test results electronically to the Department and which use a file up-load method, shall electronically report to the Department all laboratory results for Hemoglobin A1C tests, as defined in subdivision (b) of this section, within 24 hours of obtaining such results.
(b) The "Hemoglobin A1C" laboratory test represents an index of blood glucose control measuring average blood sugar over the past 90 days, and shall mean the following for the purposes of this section: HgbA1c; HgbA1c by HPLC; HbA1c; Glycohemoglobin A1C; Gycolhaemoglobin; Glycohemoglobin; Glycated Hgb; Glyco-Hb; GHb; Ghb. As defined in this section, "Hemoglobin A1C" shall not mean the following: Hgb; Hemoglobin; Hb; Hb without reference to glycated or glycosylated or A1C; or Glycohemoglobin total.
(c) Reports required by subsection (a) shall contain the information required in 24 RCNY Health Code § 13.03(a) and of paragraphs (1) through (6) thereof.
(d) Hemoglobin A1C test results and other identifying information reported to the Department pursuant to this section shall be confidential and shall not be disclosed to any person other than the individual who is the subject of the report or to such person's treating health care providers. If the subject of the report is a minor, information can be disclosed to the subject's parent or legal guardian.
When a clinical laboratory detects herpes simplex virus in a specimen collected from a child 60 days of age or less, the laboratory shall, unless otherwise directed by the Department, send the original specimen and any derived materials to the New York State Department of Health Wadsworth Center laboratories, or another laboratory determined by the Department for further testing as specified by the Department. If testing is conducted, positive and negative test results shall be forwarded to the Department.
(a) Registration. Every person operating a high-containment research laboratory in the City of New York must register such laboratory with the Department. Registrations will expire and must be renewed every three years. An entity or person registering with the Department must provide all the information requested by the Department on the registration form, including but not limited to:
(1) Name, address and other contact information for the officers or persons in control of the operating entity;
(2) Locations and biosafety level rating or ratings for each research laboratory operated by the registering entity;
(3) Name, title and contact information of at least two designated persons who are individuals at the research laboratory designated to submit to the Department the reports required by 24 RCNY Health Code § 13.13, provided that one such designated person is the manager or other person in control of the research laboratory biosafety committee; and
(4) A listing of all biological agents stored or used in each high-containment research laboratory at the time of registration. The listing must include the parent strain of the agent and any derivative strains identified by the high-containment research laboratory as having unique virulence or pathogenic potential.
(b) New facilities. Any person intending to operate a new high-containment research laboratory must register such laboratory according to this section before such laboratory commences operation.
(c) Changes in registration information. The registrant must notify the Department within thirty (30) calendar days of any changes to the information provided on the registration form that pertains to any select agent or high-risk agent.
(Added City Record 6/15/2016, eff. 12/12/2016)
(a) Loss or theft of a biological agent. No later than four hours after determining that there has been a theft or loss of a biological agent from a high-containment research laboratory, the laboratory operator or a person designated on the registration form of such laboratory must notify the Department of such theft or loss at a telephone number designated by the Department. Any theft or loss must be reported even if the lost or stolen biological agent is subsequently recovered and/or the responsible parties are identified. The following information must be provided:
(1) The name of the biological agent and any and all of its identifying information (e.g., strain or other characterization information);
(2) The quantity or an estimate of the quantity of the biological agent that was lost or stolen;
(3) The time or an estimate of the time during which the theft or loss occurred;
(4) The location (building, room) from which the theft or loss occurred.
(b) Exposure to or unintentional release of biological agents. Within one hour of determining that a person may have been exposed to a biological agent stored or used in a high-containment research laboratory, or of any unintentional release of a biological agent, or of an illness associated with exposure to a biological agent used or stored in a high-containment research laboratory, the laboratory operator or a person designated on the registration form of such laboratory must notify the Department of the actual or potential exposure at a telephone number designated by the Department. The following information must be provided:
(1) The name of the biological agent and any and all of its identifying information (e.g., strain or other characterization information);
(2) An estimate of the number of persons potentially exposed to the biological agent in or by the research laboratory and within the entity;
(3) An estimate of the quantity of biological agent that was released;
(4) An estimate of the time and duration of the release of the biological agent;
(5) The environment into which the biological agent was released (e.g., within vs. outside building, into a waste system);
(6) The location (building, room) from which the release of the biological agent occurred;
(7) Identification and contact information for all persons known to be exposed to the biological agent;
(8) Actions taken to respond to the release of the biological agent; and
(9) Hazards posed by the release of the biological agent.
(c) No requirement of this section affects any other obligation under any other law or regulation for a high-containment laboratory to report the loss, theft or release of a biological agent to any other law enforcement or regulatory agency.
(d) All information, records and reports required by this section shall be kept confidential, provided that the Commissioner may disclose to a city, state or federal agency information necessary to respond to an emergency after determining such an emergency exists.
(Added City Record 6/15/2016, eff. 12/12/2016)
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