§ 13.03 Report of Findings, Supplemental Testing, and Submission of Isolates.
(a) The director of a clinical laboratory conducting an examination of a specimen submitted for analysis shall, except as noted below with respect to blood banks, report to the Department, within 24 hours of obtaining results, all positive or reactive laboratory findings which indicate the presumptive or confirmed presence of any disease or condition required to be reported by subdivision (a) of 24 RCNY Health Code § 11.03, and also any laboratory findings which are otherwise required to be reported pursuant to this section or this Article; provided that findings indicating the presumptive or confirmed presence of diseases or conditions required to be reported pursuant to paragraph (1) of subdivision (b) of 24 RCNY Health Code § 11.03, as well as outbreaks or suspected outbreaks, unusual manifestations of disease or conditions and unusual diseases required to be reported pursuant to subdivision (c) of 24 RCNY Health Code § 11.03, shall also be reported to the Department immediately by telephone. A clinical laboratory which refers a specimen to another laboratory for examination shall provide to the testing laboratory all of the information the testing laboratory will need to fully comply with the reporting requirements set forth in this Article or this Code; provided, however, that if a blood bank refers a specimen to a laboratory for testing without donor identifying information, then the referring blood bank, and not the testing laboratory, shall comply with the reporting requirements of this Article or this Code. Reports shall contain all of the information and data elements required by the reporting forms or electronic reporting format approved by the Department, including but not limited to:
(1) The full name, date of birth and address of the person from whom the specimen was taken; the race, ethnicity and gender of such person, if known; the pregnancy status of such person, if the pregnancy status is known or probable (e.g., if a pre-natal panel was ordered) and if it is clinically relevant to the positive laboratory results, for example, a positive hepatitis B surface antigen or a positive syphilis test result; the specimen source; and the date the specimen was collected; patient email and mobile phone number, if known; provider email, fax number, mobile phone number and National Provider Identification (NPI) number if known; and facility National Provider Identification (NPI) number.
(2) The medical record number if known, identification number or code assigned to the person, if any, and other personal identifiers as may be required by the Department.
(3) The name, address and telephone number of the physician or other authorized health care practitioner who submitted the specimen, the health care facility, if any, that submitted the specimen, and the clinical laboratory that referred the specimen, if any.
(4) The name and address of the clinical laboratory which performed the test.
(5) The date the test or tests results were first available.
(6) The name(s) of test or tests performed.
(7) The positive or reactive results (including quantitative results related to positive or reactive serologic tests for reportable diseases or conditions specified by the Department if quantitative testing was performed).
(8) The antimicrobial susceptibility testing results for bacterial and fungal diseases listed under subdivision (a) of 24 RCNY Health Code § 11.03. This requirement includes traditional broth, agar and newer automated methods of antimicrobial susceptibility testing, as well as molecular-based methods that assay for molecular determinants of antimicrobial resistance.
(b) (1) With regard to tuberculosis, reports shall also include all laboratory findings which indicate presumptive or confirmed presence of tuberculosis, the results of smears found positive for acid fast bacilli (AFB), all results including negatives and species identification on samples which had positive smears, all results including negative and indeterminate results of blood-based or other later-developed laboratory tests for tuberculosis infection, all drug susceptibility testing results and all subsequent test results on samples collected within one year from any patient who had a previous positive AFB smear or a positive Mycobacterium tuberculosis complex test result (e.g., culture or NAA). Reports shall specify the laboratory methodology used and shall state if applicable whether the specimen was susceptible or resistant to each anti-tuberculosis drug at each concentration tested.
(2) With regard to syphilis:
(A) All syphilis test results, whether positive, negative or indeterminate, shall be reported to the Department. For purposes of this paragraph, syphilis tests include, but are not limited to, treponemal tests, non-treponemal tests and direct detection tests, such as darkfield microscopy, direct fluorescent antibody and polymerase chain reaction tests.
(B) Where the result of a treponemal or non-treponemal syphilis test is indeterminate, the laboratory must perform additional testing as provided herein. For purposes of this subparagraph, an indeterminate test result is one in which the result of a test is weakly reactive, minimally reactive, equivocal, inconclusive, or otherwise indeterminate; an indeterminate result does not include instances where two separate tests have conclusive but discordant results.
i. When a treponemal test result is indeterminate, the laboratory must perform, or refer the specimen to another laboratory for the performance of, a second treponemal test on the same specimen using an alternate treponemal test within 24 hours of obtaining the indeterminate result. Where the result of the second treponemal test is also indeterminate, whether performed by the same laboratory or a different laboratory, no additional treponemal test is required.
ii. When a non-treponemal test result is indeterminate, the laboratory must perform, or refer the specimen to another laboratory for the performance of, a second non-treponemal test on the same specimen using the same or an alternate non-treponemal test within 24 hours of obtaining the indeterminate result. Where the result of the second non-treponemal test is also indeterminate, whether performed by the same laboratory or a different laboratory, no additional non-treponemal test is required.
(3) (A) With regard to hepatitis A, B, or C, reports shall also include the results of alanine aminotransferase testing (ALT) if performed on the same specimen that tests positive for any of the reportable viral hepatitides.
(B) With regard to hepatitis B, all hepatitis B DNA, hepatitis B e antigen and hepatitis B surface antigen test results must be reported, including positive, negative and indeterminate results. In addition, all hepatitis B surface antibody test results, including positive, negative and indeterminate results, for children ages 0 days to 1,825 days (birth up to the fifth birthday) must be reported electronically in accordance with subdivision (c) of this section when patient age is known. Blood bank laboratories and other laboratories that perform hepatitis B DNA, hepatitis B e antigen or hepatitis B surface antigen tests on donated blood are exempt from reporting negative and indeterminate hepatitis B DNA, hepatitis B e antigen or hepatitis B surface antigen test results for such donated blood.
(C) With regard to hepatitis C:
(i) All hepatitis C nucleic acid amplification and hepatitis C antibody test results, including positive, negative and indeterminate results, must be reported electronically in accordance with subdivision (c) of this section. Blood bank laboratories and other laboratories that perform hepatitis C nucleic acid amplification and hepatitis C antibody tests on donated blood, without a positive hepatitis C antibody test, are exempt from reporting negative hepatitis C nucleic acid amplification or hepatitis C antibody test results for such donated blood.
(ii) If an antibody test is positive for hepatitis C virus, the laboratory must perform, or refer the specimen to another laboratory for performance of, a confirmatory RNA test on the same specimen or a second specimen collected at the same time as the initial specimen. The confirmatory RNA test must be initiated, or the specimen forwarded to another laboratory for that purpose, within 72 hours of obtaining the positive antibody test result.
(4) If a culture-independent diagnostic test or other laboratory test demonstrates the possible presence of Listeria monocytogenes, Salmonella, Shigella, Vibrio, or Yersinia in a patient specimen, the laboratory must perform, or refer the specimen to another laboratory for performance of, culture on the original specimen to isolate the organism. The culture must be initiated, or the specimen forwarded to another laboratory, within 72 hours of obtaining the positive culture-independent diagnostic test or other laboratory test result. The laboratory that performed the culture-independent diagnostic test or other positive test for one of the listed enteric pathogens must report the results of the subsequent culture test, whether positive or negative and whether performed by it or another laboratory, to the Department within 24 hours of obtaining the result. The laboratory that performed the culture must submit the resulting isolates, if any, to the Department in a manner and form prescribed by the Department. In the case of Shiga toxin-producing Escherichia coli, the laboratory must submit (i) an isolate or (ii) a Shiga toxin-positive broth (if available) and stool to the Department in a manner and form prescribed by the Department.
(c) Reports required pursuant to this article shall be made in a manner and form prescribed by the Department. Notwithstanding any other provision of this Code, clinical laboratories shall report to the Department using electronic or computer media prescribed by the Department in a format specified by the Department, including through the use of the electronic reporting system utilized by the New York State Department of Health. Written paper reports may be submitted for a limited period of time only in the case of extenuating circumstances, temporary equipment failure, or prolonged inability to access the Internet, and only with the specific approval of the Department. In addition, the Department may, on its own initiative, allow written, paper reports to be submitted if electronic reporting is not possible in a particular circumstance, as a result of a deficiency in the Department's or the State Health Department's electronic reporting system. The Department may, in addition, require summary, cumulative or periodic reports on such reporting schedule as it may deem necessary.
(Amended City Record 12/13/2016, eff. 1/12/2017; amended City Record 9/20/2017, eff. 10/10/2017; amended City Record 3/19/2018, eff. 4/18/2018; amended City Record 10/15/2019, eff. 11/14/2019; amended City Record 12/29/2023, eff. 1/28/2024; amended City Record 3/31/2025, eff. 4/30/2025)
