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Adopted Rules: Closed to Comments

Adopted Rules Content: 
 
 

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)

 

 

Effective Date: 
Fri, 10/20/2017

Proposed Rules: Closed to Comments (View Public Comments Received:5)

Agency:
Comment By: 
Thursday, July 27, 2017
Proposed Rules Content: 
 
                                                                 Statement of Basis and Purpose

 

 Pursuant to New York Public Health Law Section 580(c), 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 the manner in which laboratory tests must be performed and the reporting of test results.

To conduct more effective, timely, and complete disease surveillance and control in regard to Hepatitis C, the Department is proposing that the Board amend Health Code Article 13 as follows:

                                                                 Hepatitis C Testing and Reporting

            The Department is requesting that the Board amend Health Code §13.03(b)(3) to require laboratories to routinely perform a confirmatory RNA hepatitis C virus (HCV) test if an antibody tests 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, linked 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 patients being lost to care.

In 2016, only 48% of patients newly diagnosed and testing antibody positive who were reported to the Department had a confirmatory RNA test 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 tests is aligned with 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)

                                                                     Statutory Authority

The authority for these proposed amendments is found in Sections 556 and 558 of the New York City Charter (the “Charter”). Sections 558(b) and (c) of the Charter empower the Board to amend the Health Code and to include all matters to which the Department’s authority extends. Section 1043 grants the Department rule-making authority.

Section 556 of the Charter provides the Department with jurisdiction to protect and promote the health of all persons in the City of New York.

                                                                 Statement pursuant to Charter §1043

This proposal was not included in the Department’s Regulatory Agenda for FY 2017 because the need for the proposal was not known at the time the Regulatory Agenda was promulgated.

 

 

Subject: 

Proposed resolution to amend Article 13 (Laboratories) of the New York City Health Code regarding the performance of confirmatory Hepatitis C RNA testing.

Location: 
New York City Department of Health and Mental Hygiene, Gotham Center
42-09 28th Street 14th Floor, Room 3-32
Queens, NY 11101
Contact: 

Svetlana Burdeynik at (347) 396-6078 or resolutioncomments@health.nyc.gov

Download Copy of Proposed Rule (.pdf):