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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): 

Adopted Rules: Closed to Comments

Adopted 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 the manner in which laboratory tests must be performed and the reporting of test results. In addition, the Department is required to 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 Board is amending Health Code Articles 11 and 13 as follows:

Hepatitis D and E and Other Suspected Infectious Viral Hepatitides Reporting

Hepatitis D and E and “other suspected infectious viral hepatitides” are being removed from Health Code §11.03(a)’s list of reportable diseases and §13.03(b)(3)’s requirements regarding reportable laboratory findings. The New York State Sanitary Code does not require reporting of either hepatitis D or E, nor do a majority of United States jurisdictions.

Hepatitis D and E and “other suspected infectious viral hepatitides” were added to the list of reportable diseases in 2005, largely due to outbreaks of hepatitis D and E observed abroad.  After 10 years of surveillance, the Department has determined that these viruses no longer need to be monitored. Hepatitis D is uncommon in the United States. It is an “incomplete virus” in that it can replicate in the presence of hepatitis B virus; thus, hepatitis D is usually detected in connection with hepatitis B infection or outbreak and need not be separately reported. Since hepatitis D cannot be transmitted in the absence of the hepatitis B virus, hepatitis B immunization and treatment are the best approaches to reduce hepatitis D incidence. There were only 21 reports of hepatitis D in New York City from 2013 to 2015.

Hepatitis E outbreaks have not occurred in New York City. Most hepatitis E cases are linked to foreign travel and most persons infected with the virus recover completely. There is no specific vaccine or antiviral therapy for acute hepatitis E. In addition, hepatitis E cases are often misreported, for reasons including the high false-positive rate of hepatitis E tests. Of 86 hepatitis E cases reported 2006-2009, 67 percent were determined not to be actual cases and 89 percent of confirmed cases had a history of foreign travel. For these reasons, and to redirect Department resources to address more urgent public health threats, the Department stopped routine investigation of hepatitis E cases in 2010. 

Any novel strains of viral hepatitis are reportable as part of providers’ obligation to report unusual manifestations of disease and any newly apparent or emerging disease under Health Code §11.03(c)(1). Thus, it is unnecessary and redundant to have a separate reporting requirement for these hepatitis strains.

Zika Reporting

Pursuant to Health Code §11.03(a), all confirmed cases and carriers of an acute arboviral infection must be reported to the Department within 24 hours. Although Zika virus is currently reportable as an acute arboviral infection, the Board is amending Health Code §11.03(a) to expressly include Zika virus in the list of named acute arboviruses for clarity. For reportable conditions, the Department can monitor New Yorkers to ascertain where the infection was acquired, helping the Department implement prevention strategies. The Department can also investigate to promptly recognize novel forms of transmission, including by local mosquitos.

Tuberculosis Reporting for Children Less Than Five Years of Age 

            Children less than five years of age infected with tuberculosis (TB) are at increased risk for progressing to active disease and developing life-threatening forms of the disease, such as disseminated TB and TB meningitis. For this reason, the Health Code requires providers to report a positive reaction to the purified protein derivative Mantoux test or other recognized TB diagnostic test for this age group.

The Board is amending Health Code §11.03(a) and §11.21, regarding tuberculosis reporting, to further augment the reporting requirements for children less than five years of age to require providers to submit qualitative and quantitative test results and radiology reports where there is a positive test for TB infection, and report initiation of treatment for TB infection. This information will enable the Department to help ensure that providers have ruled out active TB disease and that they initiate appropriate treatment in patients. Further, requiring routine submission of radiology reports will save the Department time and resources currently spent to obtain such reports.

In addition, §13.03(b)(1) of the Health Code, regarding laboratory reporting of tuberculosis, is being amended to require laboratories to report positive results for TB infection obtained from a blood-based test (e.g., interferon-gamma release assays) or other laboratory test when performed on children less than five years of age. Currently, only providers submit positive TB test results for this age group. Requiring reporting by both laboratories and providers will help ensure the Department is made aware of all children less than five years of age with a positive test for TB infection.

Immunization Reporting

            Health Code §11.07(a)(3) is being amended to allow for adult patients’ non-written consent for immunization reporting (currently, consent must be in writing). State Public Health Law § 2168 was amended in 2013, with the support of the Department, to similarly allow non-written consent for reporting to the State-run registry, and subparagraph 2168(3)(b)(i) allows non-written consent for reporting to the City registry. Written consent is a barrier to immunization reporting and eliminating this requirement will help increase provider reporting.  

Isolation of Suspected and Confirmed Varicella Cases

            The Board is amending Health Code §11.17(a), regarding control and isolation of certain diseases, to require isolation of patients with suspected or confirmed varicella in hospitals and other clinical facilities, as is required for other communicable diseases that pose a significant threat to public health. Since varicella can be spread by air, isolation is important to reduce the risk of transmission in healthcare facilities. As a recent example, in June 2016, a one-year-old baby developed varicella infection after being exposed to patients with varicella at a medical facility. The proposed language has been modified to clarify that varicella includes both primary varicella (chickenpox) and disseminated zoster, and that patients with either disease must be isolated.

Syphilis Testing and Reporting

The Board is amending Health Code §13.03(b)(2) to require laboratories to report indeterminate syphilis test results and, where a result is indeterminate, perform a second test on the same specimen and report the result of that test. If the result of the second test is also indeterminate, the laboratory would not be required to perform additional testing. While many laboratories already report indeterminate test results, it is not explicitly required in the Health Code. The amendment provides for more complete reporting. Based on a comment received, the proposal has been modified to clarify that “indeterminate” results do not include instances in which two separate tests have conclusive but discordant results.

In 2015, there were 1,968 indeterminate syphilis test results reported to the Department. The standard approach to resolving an indeterminate test is for a laboratory to retest the same specimen with the same or an alternate diagnostic test or for a healthcare provider to collect another specimen from the patient and test that specimen. To help ensure prompt initiation of treatment of individuals with syphilis, the Department classifies indeterminate test results as positive. This results in the initiation of case investigation and field activities, which include Department staff contacting providers, laboratories, patients, and sex partners of patients.

Requiring laboratories to routinely perform a second syphilis test at the time an indeterminate result is obtained will enable prompt treatment initiation and reduce the risk of disease progression and transmission if the test is positive. The Department will also be able to focus its resources on those New Yorkers with confirmed infections or exposure to infected persons.

Other minor language changes that have no bearing on provider reporting obligations are being made to simplify and clarify §13.03(b)(2).

Enteric Disease Testing and Isolate Submission

            The Board is amending Health Code §13.03(b) to require laboratories to perform culture testing on all specimens that are found to be positive by a culture-independent diagnostic test (CIDT) for certain enteric bacterial pathogens (Campylobacter, Listeria monocytogenes, Salmonella, Shigella, Vibrio, and Yersinia). Culture testing involves a laboratory using a specimen to grow the pathogen; a sample of the pathogen grown by culture is termed an “isolate.” The amendment also requires laboratories to submit all resulting isolates to the Department. For Shiga toxin-producing Escherichia coli (STEC), laboratories will be required to submit Shiga toxin-positive broth (if available) and stool or an isolate. In response to comments received, the proposed requirements have been modified to reflect that where no isolate is produced, only the negative result need be reported, and that the broth need be submitted only if available. The proposed requirements have also been modified to include a timeframe for initiating or ordering the culture testing.

Laboratories are increasingly using CIDTs and not performing culture testing. At least two New York City laboratories can no longer perform bacterial culture on stool specimens, and several New York City laboratories have limited capabilities. The Department and other public health agencies in the United States rely on testing isolates of enteric pathogens to detect and manage outbreaks. Isolates of enteric pathogens undergo testing at the Department laboratory by methods such as pulsed-field gel electrophoresis, colloquially known as ‘DNA fingerprinting.’ The Department combines the results of ‘DNA fingerprinting’ with patient interviews and environmental investigation to confirm and remediate sources of food contamination. CIDTs do not yield isolates for such testing.

The Centers for Disease Control and Prevention encourages laboratories to culture enteric specimens with a positive CIDT result (Morbidity and Mortality Weekly Report. Centers for Disease Control and Prevention. Bacterial Enteric Infections Detected by Culture-Independent Diagnostic Tests — FoodNet, United States, 2012–2014. MMWR. 2015;64(09):252-257). The Association of Public Health Laboratories (APHL) recommends that “all public health departments establish legal requirements for the submission of enteric bacterial disease isolates and/or clinical specimens by hospital and clinical laboratories. . . .” APHL’s position is based in part on its finding that “[t]he rapidly increasing availability of CIDTs for foodborne pathogens poses serious challenges for public health and is threatening to derail current laboratory-based surveillance systems” (APHL Position Statement: Establishing Legal Requirements for the Submission of Enteric Disease Isolates and/or Clinical Material to Public Health Laboratories, Approved by Membership February 2015).  Requiring laboratories to perform culture testing and submit resulting isolates is consistent with the APHL recommendation.

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 (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.

 

 

Effective Date: 
Thu, 01/12/2017