Article 11-Reportable Diseases
Proposed Rules: Closed to Comments
Statement of Basis and Purpose
These amendments to the New York City Health Code (the “Health Code”) are issued in accordance with §§556, 558 and 1043 of the New York City Charter (the “Charter”).
- Section 556 of the Charter provides the Department of Health and Mental Hygiene (the “Department”) with authority to regulate all matters affecting health in the City of New York.
- Sections 558(b) and (c) of the Charter empower the Board of Health (the “Board”) to amend the Health Code and to include in the Health Code all matters over which the Department has authority.
- Section 1043 of the Charter gives the Department rulemaking powers.
Basis and purpose of the amendments
One of the most important duties of any public health agency is to investigate and control communicable diseases. As the local health officer for the City of New York (NYC), the Commissioner of the Department is required “to make such an investigation as the circumstances may require for the purpose of verifying the diagnosis, ascertaining the source of infection….to collect and submit, or cause to be collected and submitted, for laboratory examination such specimens as may furnish necessary or desirable information in determining the source of infection or in assisting diagnosis: …” New York State Sanitary Code §2.6 [10 NYCRR Chapter 1].
Similarly, Health Code §11.03(e) provides that upon receiving a report of a disease or condition required to be reported, the Department may conduct any surveillance, epidemiological and laboratory investigation necessary to verify diagnosis, ascertain sources or causes of infection, identify additional cases, and implement public health measures to control the disease and prevent further morbidity or mortality. These provisions authorize the Department to require collection of specimens for laboratory examination for testing to be performed by the Department or as designated by the Department.
Neonatal herpes is an uncommon but serious infection with a high case fatality rate; since 2006, 15 NYC neonates have died from herpes. In 2006, Health Code §11.03 was amended to make neonatal herpes simplex virus (HSV) infection a reportable disease. There are approximately 15 laboratory-confirmed cases reported each year, and 2-4 additional cases that meet a case definition for probable infection but are not laboratory-confirmed. The Department believes that the number of confirmed cases is an underestimate, because health care providers fail to obtain specimens for herpes virus detection, do not send specimens to laboratories that can perform the necessary testing, and obtain specimens after starting anti-viral treatment, which can reduce the likelihood of detecting virus in a specimen.
State Sanitary Code §2.5 provides that a “physician in attendance on a person affected with or suspected of being affected with any of the diseases mentioned in this section shall submit to an approved laboratory, or to the laboratory of the State Department of Health, for examination of such specimens as may be designated by the State Commissioner of Health, together with data concerning the history and clinical manifestations pertinent to the examination: … Herpes infection in infants aged 60 days or younger (neonatal) …”
Nucleic Acid Amplification Tests (NAAT)
Nucleic acid amplification tests (NAAT) are a form of molecular testing. They are more sensitive than cultures for the detection of HSV infection. However, few health care providers and hospitals have ready access to laboratories that are able or authorized to perform NAAT on swabs from skin vesicles, and opportunities for laboratory-confirmation of herpes infection have been missed. The New York State Department of Health Wadsworth Center laboratories have the ability to perform NAAT and other molecular analyses.
Highly sensitive NAAT testing of suspected neonatal herpes specimens benefits individual cases and public health in three ways:
(1) It enables confirmation of the diagnosis, and reassures physicians and parents that, given the serious threat to the neonate’s life posed by a herpes infection, treatment for herpes should be started and continued despite the risks associated with such treatment.
(2) Public health officials can more accurately document disease incidence.
(3) Public health officials can prioritize cases for investigation to determine how transmission occurred and how it can be prevented in the future.
Amendment of Article 11
The Department is proposing that the Board amend Article 11 to add a new §11.10 requiring health care providers to obtain swab specimens from vesicular skin lesions in a neonate presenting with possible HSV infection before or when starting treatment of the infant with anti-viral drugs, and submitting the specimens to the NYS Department of Health Wadsworth Center laboratory, for diagnostic testing. State Sanitary Code §2.5 provides that a “physician in attendance on a person affected with or suspected of being affected with any of the diseases mentioned in this section shall submit to an approved laboratory, or to the laboratory of the State Department of Health, for examination of such specimens as may be designated by the State Commissioner of Health, together with data concerning the history and clinical manifestations pertinent to the examination [in cases of]: … Herpes infection in infants aged 60 days or younger (neonatal) …” The State Sanitary Code clearly states the authority of the State Commissioner of Health to require submission of such specimens, and the Department believes that a similar provision is necessary in the City’s Health Code. The Department does not intend that this requirement result in delaying necessary treatment.
Amendment of Article 13
The Department is also proposing that the Board amend Article 13 to add a new §13.09 to require that clinical laboratories detecting HSV in any specimen from infants sixty days of age or less submit a portion of such specimens and derived materials to the Wadsworth Center for further testing as needed. NYC neonatal herpes surveillance data, collected since 2006 when the disease was made reportable, are used for local and national provider education and to support investigations to determine if cases are related. However, even when infection is laboratory-confirmed as HSV infection, viral type (indicating whether infection is due to HSV type 1 or HSV type 2) is unknown approximately 15% of the time. Data regarding viral type will help the Department understand factors associated with infection, factors associated with virulence of each type, and the impact that future vaccines are likely to have on neonatal HSV infection.