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Proposed Rules: Closed to Comments (View Public Comments Received:1)

Agency:
Comment By: 
Wednesday, October 25, 2017
Proposed Rules Content: 
 
 

Statement of Basis and Purpose

 

 The Department’s Division of Disease Control conducts disease surveillance and control activities for most of the diseases listed in Article 11 (Reportable Diseases and Conditions) of the Health Code. The Division of Disease Control also enforces Article 13 (Clinical Laboratories) of the Health Code, which regulates how laboratory tests must be performed and the reporting of test results. In addition, the Department must comply with various provisions of Part 2 of the New York State Sanitary Code, found in Title 10 of the New York Codes, Rules and Regulations, with respect to control of communicable diseases.

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

Hepatitis B Reporting

The Department is proposing that the Board amend Health Code §13.03(b)(3)(A) to require laboratories to report all hepatitis B virus (HBV) DNA test results, including negative results. The Health Department currently requires laboratories to report only positive HBV DNA results, in addition to other positive HBV test results.

HBV DNA testing is performed on individuals who have tested positive for HBV. HBV DNA tests measure viral load and whether the patient has chronic (active) HBV, requiring treatment. For patients already diagnosed with chronic HBV, DNA test results provide important information regarding infectiousness, treatment eligibility, and risk for development of liver cancer. For patients being treated for HBV, DNA test results provide information regarding treatment outcome (i.e., the extent to which the patient cleared the infection).

The number of HBV cases is rising nationally and in New York City. More than 100,000 New Yorkers are estimated to be living with chronic HBV, with 8,439 new cases diagnosed in 2016, an increase of 18.8% since 2013. The majority of individuals infected with HBV as adults will clear the virus on their own but many New Yorkers will develop chronic HBV. Chronic HBV can lead to serious health issues, including cirrhosis and liver cancer. All persons with chronic HBV infection require linkage to care and regular monitoring for liver damage and other complications; a subset require treatment with antiviral medications.

Without negative HBV DNA test results, the Health Department has limited knowledge regarding whether patients who have tested positive for HBV are receiving appropriate follow-up testing and treatment. Mandated reporting of negative HBV DNA test results will allow the Health Department to estimate the proportion of New Yorkers infected with HBV who are appropriately tested and linked to care; identify gaps in access to care; develop targeted interventions to increase linkage to care and improve provider knowledge of HBV testing and treatment guidelines; and increase monitoring to reduce HBV-related morbidity and mortality.

Carbapenem-resistant Enterobacteriaceae Reporting

The Department is proposing that the Board amend Health Code §11.03(a) to require laboratories to report carbapenem-resistant Enterobacteriaceae (CRE), an emerging bacterial threat. CRE are a family of bacteria that are difficult to treat because they have high levels of resistance to many antibiotics including carbapenem antibiotics. Carbapenem antibiotics are often used as the last line of treatment for infections caused by highly resistant bacteria, including those in the Enterobacteriaceae family.

As explained by the Centers for Disease Control and Prevention (CDC): “The emergence and dissemination of carbapenem resistance among Enterobacteriaceae in the United States represents a serious threat to public health. These organisms cause infections that are associated with high mortality rates and they have the potential to spread widely. Decreasing the impact of these organisms will require a coordinated effort involving all stakeholders including healthcare facilities and providers, public health, and industry.”[1] CDC has designated CRE an “urgent” threat, the highest threat level in its list of antibiotic resistance threats in the United States.[2]

CRE infections are common in hospitals, nursing homes, and other healthcare settings. Patients whose care requires devices like ventilators, urinary catheters, or intravenous catheters, and patients who are taking long courses of certain antibiotics are most at risk for CRE infections.[3] In 2015, hospitals in NYS reported 3,618 CRE cases via the CDC’s National Healthcare Safety Network (NHSN); 1,727 of these were reported by the 51 participating New York City facilities.[4] As only hospitals submit data to the NHSN, the number of CRE infections in New York is probably significantly larger.

Mandated reporting will provide vital epidemiological information regarding incidence and evolution of CRE and assist in the identification of new strains, clusters, and outbreaks. This will enable the Health Department to help ensure infection control precautions are being taken. Mandated reporting of CRE is also aligned with recently released Council of State and Territorial Epidemiologists guidelines.[5] Based on a 2016 survey, 27 jurisdictions require some form of CRE reporting.[6]

Minor changes to other parts of §11.03(a) are proposed for purposes of consistency.

 

Statutory Authority

The Health Department’s authority to promulgate these proposed amendments is found in Sections, 556, 558, and 1043 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 556 of the Charter provides the Department with jurisdiction to protect and promote the health of all persons in the City of New York. Section 1043 grants the Department rule-making authority.




[1] Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases. Facility Guidance for Control of Carbapenem-resistant Enterobacteriaceae (CRE). November 2015 Update – CRE Toolkit. https://www.cdc.gov/hai/pdfs/cre/cre-guidance-508.pdf.

[2] Centers for Disease Control and Prevention. Antibiotic Resistant Threats in the United States, 2013. https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf.

[3] Centers for Disease Control and Prevention. Carbapenem-resistant Enterobacteriaceae in Healthcare Settings. CDC website. https://www.cdc.gov/hai/organisms/cre/index.html.

[4] NYS Healthcare Associated Infections in New York State, 2015. Part 2: Technical Report. March 2017.

[5] Council of State and Territorial Epidemiologists. Infectious Disease Committee Position Statement 17-ID-04: Public Health Reporting and National notification of Carbapenemase Producing Carbapenem-Resistant Enterobacteriaceae for E. coli, Klebsiella spp. and Enterobacter spp. July 2017.

[6] Council of State and Territorial Epidemiologists. State Reportable Conditions Assessment (SRCA). http://srca.querytool.cste.org/.

 

 

Subject: 

Proposed resolution to amend Article 11 (Reportable Deceases and Conditions) and Article 13 (Laboratories) of the New York City Health Code.

Location: 
New York City Department of Health and Mental Hygiene, Gotham Center
42-09 28th Street 14th Floor, Room 14-43
Queens, NY 11101
Contact: 

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

Download Copy of Proposed Rule (.pdf):