Amendment to Reportable Diseases and Conditions and Laboratories (Articles 11 and 13 of the NYC Health Code)

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

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Comment By: 
Monday, July 22, 2019
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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 performance of laboratory tests 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 (NYCRR), with respect to the 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 Articles 11 and 13 as follows:

Tuberculosis Infection Reporting

The Department is requesting that the Board amend Health Code Sections 11.03(a) and 13.03(b)(1) to require laboratories to report all test results for tuberculosis (TB) infection, including negative results. Currently the Health Code requires reporting only of test results and other information attendant to active TB disease, and tests positive for TB infection and related information for children under five years old.

TB is a disease caused by the bacterium Mycobacterium tuberculosis, which is spread person-to-person through the air. Most commonly, TB disease affects the lungs, but it can also affect other parts of the body. Individuals who have a positive test for TB infection but do not have symptoms or other test results consistent with active TB disease are diagnosed with latent TB infection (LTBI). Persons with LTBI are asymptomatic and cannot transmit the infection to others. It is estimated that approximately 10 percent of individuals with LTBI will develop active TB disease at some point in their life. Treating LTBI is the only way to significantly reduce the risk of developing active disease and thus is a vital component of TB prevention efforts.

There is no reliable data on the prevalence of LTBI in the United States or New York City. National estimates from the National Health and Nutrition Examination Survey study, when combined with New York City population data, result in an estimate of approximately 700,000 people with LTBI in the City. However, data from the Department’s TB clinics suggests there could be as many as 1.8 million people in New York City with LTBI. Based on these estimates, there is a large reservoir of TB infection in New York City, some of which will result in future cases of active TB disease.

While the Department has made major strides in reducing the number of active TB cases in New York City – from 3,755 at the height of the TB epidemic in 1992 to 559 in 2018 – the number of TB cases has largely plateaued in the last 10 years. The Department is working to expand its efforts to identify and treat people with LTBI to further reduce the burden of TB in New York City, and reporting of test results for TB infection would help focus that effort.

Reporting of tests for TB infection would give the Department a better understanding of the prevalence of TB infection so as to better direct public health resources. Also, the data collected would provide information about testing practices, which would help inform provider outreach. Reports of laboratory tests negative for TB infection would provide the Department with a more complete picture of testing practices and allow for better estimates of testing prevalence to inform the Department’s programming.

In addition, the Department proposes minor related language changes to Health Code § 11.21(a) for consistency.

Syphilis Amendment Proposal

The Department is requesting that the Board add a new Section 11.33 to the Health Code to require healthcare providers to test pregnant persons for syphilis at 28 weeks of pregnancy, or as soon thereafter as reasonably possible no later than at 32 weeks of pregnancy, and that test results and a treatment plan be documented.

Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum. Untreated syphilis during pregnancy can result in devastating health outcomes, including stillbirth.  Infants with congenital syphilis may manifest abnormalities of the central nervous system, bones and joints, teeth, eyes, and skin. In New York City, the number of congenital syphilis cases increased 186% between 2017 (7 cases) and 2018 (20 cases) (preliminary data). Twenty is the largest number of congenital syphilis cases reported in the city in over ten years and included one syphilitic stillbirth at 31 weeks. In general, New York City has much higher rates of primary, secondary, and early latent syphilis as compared to the U.S. population. In 2017, the rate of syphilis at all stages was 95.33 per 100,000 in NYC vs. 31.4 cases per 100,000 nationally. Syphilis is increasing among New York City women; from 2017 to 2018 (preliminary data), the number of primary, secondary, and early latent syphilis cases among NYC women increased 44%, from 219 to 315 cases.

Congenital syphilis can be prevented by timely treatment of maternal syphilis. However, symptoms of maternal syphilis during pregnancy may not be apparent, so serologic screening during pregnancy is critical. New York State mandates syphilis screening at the first prenatal care examination (NYS Public Health Law § 2308) and at delivery (10 NYCRR § 69-2.2). Increasingly, the Department has documented congenital cases resulting from maternal syphilis infections acquired subsequent to screening negative earlier during pregnancy; this accounted for 11 cases (55%) of congenital syphilis cases in 2018. As many as half of these cases may have been averted by screening women at 28 weeks of pregnancy.

The Department proposes requiring an additional syphilis test at 28 to 32 weeks of pregnancy to identify pregnant people who become infected subsequent to initial mandatory screening, which will enable treatment, improve the health of the pregnant person, and prevent potentially grave health outcomes attendant to vertical transmission. Requiring documentation of test results and a treatment plan will help ensure appropriate follow-up care. Twenty-eight weeks is the most appropriate time for third trimester re-screening because other screening tests are routinely performed at 28 weeks, and because screening at this time would allow sufficient time to treat pregnant people who have syphilis prior to delivery. This proposal is aligned with laws in several other states that require third trimester syphilis testing of all pregnant persons. 

Exclusion of Cases and Carriers of Enteric Pathogens

The Department is requesting that the Board amend Health Code § 11.15(a) to provide the Department with the discretion to end “exclusion” of people infected with enteric pathogens when doing so is appropriate under the circumstances.

Under the Health Code, individuals infected with or carrying certain enteric pathogens must be excluded from certain settings where there is an elevated risk of disease transmission. Thus, cases and carriers who are food handlers or health care workers must be excluded from their place of work, and staff and attendees of schools, child care programs, camps, and other facilities attended by children under five years of age must be excluded from those facilities. The Health Code further provides that exclusion can end only when the excluded person no longer has symptoms and the Department has received two or three (depending on the pathogen) successive negative stool specimens demonstrating that transmission is no longer likely and that the excluded person’s illness is no longer a public health concern.

The enteric diseases addressed in Health Code § 11.15 –Campylobacteriosis, Cholera, Escherichia (E.) coli 0157:H7 and other Shiga toxin-producing E. coli (STEC) infections, Salmonellosis (other than typhoid), Shigellosis, Yersiniosis, Amebiasis, Cryptosporidiosis, and Giardiasis – are transmitted via the fecal-oral route. People infected with or carrying enteric pathogens who are food handlers, health care workers providing oral care or feeding, child care workers, or child care attendees can shed the organism in their stool and transmit the infection to others if they have poor hand hygiene practices. Under current requirements, exclusion can last from days to months.

The number of people identified requiring exclusion has increased significantly in recent years. In 2018, there were 187 exclusions ranging in duration from 1 to 135 days, with a mean length of 22 days, as compared to 69 exclusions in 2015. The increase in exclusions is due to improved surveillance practices and increased use of culture-independent diagnostic tests (CIDT), a testing method that is more sensitive than other types of traditional tests, leading to more positive test results. Stool samples can be positive by a CIDT but negative by traditional tests, such as bacterial culture, indicating that although the organism’s DNA is detectible, it may not be alive and capable of being transmitted. However, under the current Health Code provision, individuals must be excluded based on the positive CIDT result while awaiting follow-up culture results. Also, some individuals shed the organism in the stool for many weeks or months even after symptoms have ended, and experience suggests that the risk of transmission in that circumstance is low. As there are no clear national guidelines on exclusion, jurisdictions’ exclusion requirements vary. Many jurisdictions, including New York State, are less strict than New York City without any measured increase in disease transmission.

For these reasons the Department proposes a more flexible approach that takes into consideration the circumstances of a particular case, including the type of infection, the type of test used to detect the pathogen, the presence or absence of symptoms, the individual’s treatment with antimicrobial drugs, the individual’s job responsibilities, and the likelihood of infectiousness based on the length of time since symptom onset. The Department would still be able to exclude people with enteric pathogens until consecutive negative test results are received if, in the view of Department experts, there remains a public health threat. However, the Department would have the discretion to allow people to return to work or school sooner if their illness no longer poses a risk to others.

In addition, the Department proposes minor language changes for consistency and clarity, and to correct typographical errors.

Campylobacter Testing and Reporting

The Department is requesting that the Board amend Health Code § 13.03(b) to no longer require laboratories to perform culture testing on all specimens found to be positive for Campylobacter by CIDT. Culture testing involves a laboratory using a specimen to grow the pathogen; a sample of the pathogen grown by culture is termed an “isolate”.

In January 2017, the Health Code was amended to require follow-up culture tests on six enteric pathogens: Campylobacter, Listeria monocytogenes, Salmonella, Shigella, Vibrio, and Yersinia. The laboratory must report the results of the culture and submit any resulting isolates to the Department. The Department proposed the amendment to enable it to obtain information about the pathogens not available from CIDT and used to assist in outbreak detection and response.

Campylobacter bacteria can be transmitted to people through contaminated food and liquid or contact with certain animal feces. It causes diarrhea, fever, and abdominal cramps and, in rare cases, more serious illness. Compared to other enteric pathogens, Campylobacter is difficult to isolate and found relatively frequently, particularly given an increase in positive test results stemming from more expansive use of CIDT. Further, other enteric pathogens that are required to be cultured per the Health Code, including Salmonella and Shiga toxin-producing Escherichia coli, have more significant public health consequences than Campylobacter, including that they are more likely to be part of local and multi-state disease outbreaks.

The Department has determined that appropriate monitoring of Campylobacter can occur without routine culture testing and isolate submission. Given the high number of Campylobacter reports (approximately 2500 cases in New York City in 2018), the Department generally has been able to investigate only clusters, as opposed to isolated cases. Accordingly, the Department does not make use of most of the isolates received from laboratories. The Department can request additional testing and isolates from laboratories in the event of a suspected cluster or outbreak, rather than requiring laboratories to perform the additional testing as a matter of course. The Department believes this approach would better balance laboratory burden and public health needs.

In addition, in order to address questions raised by reporting laboratories, the Department proposes minor language changes to clarify that reports must be sent to the Department.

Statutory Authority

The Department’s authority to promulgate these proposed amendments is found in Sections 556, 558, and 1043 of the Charter. Sections 558(b) and (c) of the Charter empower the Board to amend and add to the Health Code, including with respect to 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.

 
 
Public Hearing
Subject: 

Proposed resolution to amend Article 11 (Reportable Diseases and Conditions) and Article 13 (Laboratories) of the New York City Health Code regarding various diseases and conditions.

Public Hearing Date: 
Monday, July 22, 2019 - 10:00am
Contact: 

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

Location: 
New York City Department of Health and Mental Hygiene, Gotham Center
42-09 28th Street, 14th floor, Room 14-44
Queens, NY 11101