Amendment to Clinical Laboratories (Article 13 of the NYC Health Code) Regarding the Performance of Confirmatory Hepatitis C RNA Testing

Adopted Rules: Closed to Comments

Effective Date: 
Friday, October 20, 2017
Download Copy of Adopted Rule (.pdf): 

Statement of Basis and Purpose

             Pursuant to New York Public Health Law Section 580(3), the City has the authority to regulate clinical laboratories. The Department’s Division of Disease Control enforces Article 13 (Clinical Laboratories) of the Health Code, which regulates how laboratory tests must be performed and the reporting of test results.

To conduct more effective, timely, and complete surveillance and control of hepatitis C, the Board is amending Health Code Article 13 as follows:

Hepatitis C Testing and Reporting

            The Board is amending Health Code §13.03(b)(3) to require laboratories to routinely perform a confirmatory RNA hepatitis C virus (HCV) test if an antibody test is positive for hepatitis C virus. The confirmatory test must be performed on the same specimen or a second specimen collected at the same time as the initial specimen. This requirement completes diagnostic testing and helps ensure that patients infected with HCV are aware of their status, referred to appropriate medical care and treatment, and cured, thus reducing the risk of further transmission.

           Most patients are first screened for HCV via an antibody test, which shows whether the patient has ever been infected with HCV. When a patient tests positive, a confirmatory RNA test is required to establish whether the individual is currently infected with the virus. If the provider does not order the confirmatory test at the same time as the antibody test, the patient must return for an additional blood draw for the RNA test. This multi-step testing process results in treatment delays and in patients not receiving needed care.

           In 2016, only 48% of patients newly diagnosed and testing antibody positive who were reported to the Department had a confirmatory RNA test performed on the same specimen; and a review of 2015 data shows that 22% of New York City patients newly reported as HCV antibody positive never received confirmatory RNA testing at all. A 2016 Department survey found that 33% of 21 acute care NYC hospitals do not automatically order confirmatory RNA testing for patients with a positive antibody test.

          Routine performance of a confirmatory RNA test follows Centers for Disease Control and Prevention guidelines, and will ensure that patients are accurately diagnosed, promptly treated for HCV, and receive critical related care, such as regular liver cancer screening.  (Centers for Disease Control and Prevention. Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR. 2013; 62(18):362)