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Adopted Rules: Closed to Comments

Adopted Rules Content: 
 

                                                                       Statement of Basis and Purpose    

 

Statutory Authority

            The Board’s authority to codify 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.

Background       

The Department is responsible under the Charter for supervising matters affecting the health of New Yorkers.  Through its Division of Disease Control, the Department conducts disease surveillance and control activities for most of the diseases listed in Article 11 (Reportable Diseases and Conditions) of the Health Code.  The same Division 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 proposed to the Board and the Board is amending Health Code Articles 11 and 13 as follows:

Tuberculosis Infection Reporting

The Board is amending 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. Prior to the adoption of these amendments, the Health Code required 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 will help focus that effort.

Reporting of tests for TB infection will give the Department a better understanding of the prevalence of TB infection in order to better direct public health resources. Also, the data collected will provide information about testing practices, which will help inform provider outreach. Reports of laboratory tests negative for TB infection will 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 Board has made minor related language changes to Health Code § 11.21(a) for consistency.

In response to public comments received, the language of the Department’s proposal as to this provision has been revised to clarify that laboratories must report all test results, including negatives, for tests for TB infection only, and not tests performed in connection with diagnosing or monitoring active TB disease, such as mycobacteria culture tests.

Syphilis Amendment Proposal

The Board is adding 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 but 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). 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, 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. At least half of these cases may have been averted by screening women at 28 weeks of pregnancy.

The Board adopts the Department’s proposal to require 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. These changes now align the Health Code 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 Board is amending 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 were required to be excluded from certain settings where there was an elevated risk of disease transmission. Thus, cases and carriers who are food handlers or health care workers have to 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 had to be excluded from those facilities. Under the current provision, the Health Code provides that exclusion can end only when the excluded person no longer has symptoms and the Department had 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. 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 Health Code provision prior to the adoption of these changes, individuals have to be excluded based on the positive CIDT result while awaiting for multiple 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, exclusion requirements of jurisdictions 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 adoption of this proposal still allows the Department to exclude people with enteric pathogens until consecutive negative test results are received if, in the view of Department experts, there remained 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 Board is adopting is minor language changes to this provision for consistency and clarity, and to correct typographical errors.


Campylobacter Testing and Reporting

The Board is amending 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 the following enteric pathogens: Campylobacter, Listeria monocytogenes, Salmonella, Shigella, Vibrio, Yersinia, and Shiga toxin-producing Escherichia coli. 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 better balances laboratory burden and public health needs.

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

 
 
Effective Date: 
Fri, 11/15/2019

Adopted Rules: Closed to Comments

Adopted Rules Content: 
 
 

Statement of Basis and Purpose

    I.    The Dangers of Lead Exposure

Children exposed to any level of lead may face serious, irreversible harm that has consequences throughout their lifetimes. Children under the age of six are at greatest risk for exposure because they explore the world through hand-to-mouth activity and because their bodies are rapidly growing and can more readily absorb lead.  Elevated blood lead levels in children can result in behavioral changes, reduced educational attainment and hearing and speech delays. In 2012, the Centers for Disease Control and Prevention (CDC) explained that there is no safe blood lead level (BLL) for children, announced that 98.5% of children nationally had a BLL below 5 micrograms per deciliter (mcg/dL), and recommended public health action at this defined “reference level.”  In adults, lead exposure can increase risk of hypertension, peripheral neuropathy, renal dysfunction, and adverse reproductive outcomes. Pregnant women present a unique concern because lead exposure can affect the health of both the woman and the fetus. Since symptoms of elevated BLLs are often not immediately observable and many adverse health effects are irreversible, preventing exposure before it occurs and reducing future exposures are the only effective ways to protect children and adults from lead’s deleterious effects.

  II.    Lead in Paint

Lead in paint remains the most common source of lead exposure for New York City children.  As the older layers of lead-based paint from previous decades remain on interior surfaces, such layers peel, crack, chip, or flake. Very young children – especially those under the age of three – are most at risk as this peeling or chipped lead-based paint and dust easily end up on a crawling baby or toddler’s hands and toys and then into their digestive systems due to developmentally appropriate hand-to-mouth activity.  At critical stages of physical development, these very young children absorb lead at higher rates than older children and adults, putting them at the greatest risk of all when exposed to lead. 

New York City has long been at the vanguard of efforts nationally to reduce BLLs in children, beginning in 1960 when the Board of Health made New York City one of the first jurisdictions in the country to prohibit the use of lead paint in residential settings, 18 years before it was banned by the federal government. Because of strong laws, regulations, policies and procedures—including the requirements of the Health Code—New York City has seen close to a 90 percent decline since 2005 in the number of children under age six with a BLL at or above 5 mcg/dL.

The New York City Childhood Lead Poisoning Prevention Act (“Local Law 1”), enacted in 2004, required the Department to investigate the potential sources of lead in the home and elsewhere when it receives a report of children under 18 years old with a BLL level at or above 15 mcg/dL.[1]  Complementing Local Law 1, the Health Code was amended to define “lead-based paint” as paint with a lead content of 1.0 milligrams per centimeter squared (mg/cm2).  It also has required that:

  • Health care providers and clinical laboratories notify the Department of BLL test results of 10 mcg/dL or greater within 24 hours (Health Code section 11.03) and all BLL test results within five business days (Health Code section 11.09);
  • DOHMH conduct investigations of children under 18 years old with BLLs at or above 15 mcg/dL to identify sources of lead and order abatement as needed (Health Code section 173.13(d)(2));
  • If lead-based paint hazards are identified based on a report of a child with a BLL of 15 mcg/dL, a Commissioner’s Order to correct the hazard be issued, requiring the owner to correct the violation within five days (Health Code section 173.13(d)(2)); and 
  • The maximum content of lead dust permitted for re-occupancy of a unit is 40 mcg/ft2 for floors, 250 mcg/ft2 for window sills, and 400 mcg/ft2 for window wells (Health Code section 173.14(e)(1)(I)(iv)).

               Based on changes in federal guidelines and evolving scientific evidence, the Department has been conducting investigations for children at BLLs lower than Health Code mandates, including at 8 mcg/dL and above for children under 16 months old, and 10 mcg/dL and above for children under six years old. These environmental investigations include a comprehensive risk assessment and environmental sampling of the child’s residence and any supplemental addresses. The environmental sampling includes testing peeling paint and dust for lead content. The Department has been taking public health action for children with a BLL of 5 mcg/dL and above since 2009, by notifying parents and health care providers about the blood lead test results and providing recommendations for follow-up testing and interventions.  Beginning in 2018, the Department began conducting environmental investigations for all children under 18 years old with a BLL of 5 mcg/dL or greater.

                In light of such changes in guidelines and scientific evidence, and to align with recent amendments to local law, the Board has adopted updates to relevant Health Code provisions related to childhood lead paint exposure interventions as described below.  Among the updates is redefining “lead-based paint” from a lead concentration threshold of 1.0 mg/cm2 to 0.5 mg/cm2 and from paint with a metallic lead content of 0.5% or greater to 0.25% or greater once the New York City Department of Housing Preservation and Development (HPD) confirms via rulemaking that there is at least one Performance Characteristic Sheet (PCS) published by the United States Department of Housing and Urban Development or other sufficient written technical guidance approving a commercially available x-ray fluorescence (XRF) analyzer tested at the level of 0.5 mg/cm2.  In addition, since the Department’s review of XRF readings taken from residences of children with BLLs of 8 mcg/dL and above show that paint with lead content below current Health Code levels presents a risk to children, the Board is adopting this more protective standard to order abatement of non-intact paint where an XRF reading is 0.5 mg/cm2 and there is a child with under 18 years old with a BLL of 5 mcg/dL or greater. In this manner, property owners are on clear notice that the Department will take enforcement action when needed if these lower lead levels in non-intact paint are present in the home of a child with a BLL of 5 mcg/dL or higher.

     III.         Consumer Products as a Source of Lead Exposures

While lead-based paint remains the primary source of lead exposure for New York City children, consumer products—such as certain supplements or remedies, cosmetics, religious powders, jewelry, and spices—are also often identified as potential lead sources associated with elevated BLLs. This poses a special challenge in New York City, where many residents come from a broad spectrum of ethnic, cultural, and religious backgrounds and use imported goods that may contain lead or other heavy metals at unsafe levels not permitted in goods produced in the United States.

To address this challenge, the Department has a comprehensive approach to identifying and reducing exposure to lead in consumer products that includes surveying stores to find potentially hazardous products, conducting enforcement actions to remove the products from sale and use, and providing risk communication and public education to prevent future use of the products. The Department has tested thousands of consumer products for lead and other heavy metals since 2011, of which hundreds of product samples have been found to contain elevated lead or other heavy metals. From September 2014 through 2018, the Department surveyed more than 700 New York City stores to determine the availability of hazardous consumer products and embargoed more than 19,000 hazardous consumer products. 

Multiple federal laws regulate non-paint sources of lead, including the Consumer Product Safety Act, the Federal Hazardous Substances Act, the Food, Drug and Cosmetic Act, and their attendant regulations, guidelines, and other publications.  These federal laws, regulations and guidelines provide baselines for permissible levels of lead in consumer products and other substances nationwide.  Combined, these laws and regulations provide a continuously evolving set of complex standards by which products and substances are regulated to protect the public health.  Some states and localities have taken steps to augment the federal standards.  In New York State, Education Law § 6818 bans the sale of cosmetics containing poisonous or deleterious substances. In New York City, Administrative Code § 17-189 prohibits the sale of lead-containing candy and litargirio.  California and Minnesota have made lead levels for adult jewelry closer to that required federally for children’s jewelry.[2] [3] Many states have also adopted the federal standards for lead content in children’s toys.

While the Health Code previously incorporated federal standards for lead content in consumer products, food, drugs, and cosmetics, these provisions were not specific about items with dangerous levels of lead.  The Board has therefore adopted amendments to clarify criteria for specific products that are banned for sale, use, and transfer in the City due to their lead content.  The Board has also adopted specific Health Code provision to authorize the Department to seize, embargo, or condemn products and substances with dangerous levels of lead.  And finally, the Board has adopted a provision for a safe products awareness training program as a requirement for individuals and entities who offer for sale or otherwise distribute hazardous lead-containing products or materials. Such a program will assist small businesses and others in identifying products they are not supposed to sell in the future and thereby expand the positive impact of Department enforcement action.

       IV.     Summary of Proposed Health Code Amendments

The following is a summary of the adopted amendments to the Health Code:

  1. All BLL test results of 5 mcg/dL or greater must be reported to the Department within 24 hours and removing “lead poisoning” from the reportable condition of “poisoning by drugs or other toxic agents” (Section 11.03(a));
  2. BLL test results below 5 mcg/dL must also be reported to the Department (Section 11.09(a));
  3. The BLLs of children under 18 years of age has been lowered from 15 mcg/dL to 5 mcg/dL when the Department is required to issue abatement orders if a lead-based paint hazard is identified in a dwelling where children reside (Section 173.13(d)(2));
  4. A trigger to redefine “lead-based paint” from a lead concentration threshold of 1.0 mg/cm2 to 0.5 mg/cm2 and from paint with a metallic lead content of 0.5% or greater to 0.25% or greater once the conditions of NYC Administrative Code section 27-2056.2(7)(b) have been met to redefine the term citywide (Section 173.14(b));
  5. Definition of “unsafe lead paint condition” to mean non-intact paint with a concentration of lead equal to or greater than 0.5 but not greater than 0.9 milligrams per square centimeter or with a metallic lead content of 0.25% or greater regardless of whether a PCS has been issued for an XRF at these levels (Section 173.14(b));
  6. The clearance level for dust wipes for floors and window wells and sills has been lowered (Section 173.14(e)(1)(I)(iv));
  7. Clarification that cosmetics containing lead that could cause harm to users is not permitted, and specifying that kohl, kajal, al-Kahal, surma, tiro, tozali, kwalli, and litargirio, among other substances, are banned from sale (Section 71.05(g)(1));
  8. Addition of a new parapgraph to the definition of per se hazardous substances to specify the danger of lead exposure, and banning the sale of certain ceramic ware not suitable for use with foods and any jewelry that does not meet the federal standards for children’s jewelry (Section 173.01(i)(5));
  9. Conspicuous warnings are required on ceramic ware not suitable for use with food (Section 173.05(e)); and
  10. The sale, use, and transfer of hazardous or toxic substances or products is not permitted, and the Department has the authority to seize, embargo, or condemn any such items, and that violators may be required to take a safe products awareness training program (Section 173.21).

 

Statutory Authority

These amendments to the Health Code are promulgated pursuant to Sections 558 and 1043 of the New York City Charter.  Section 558 empowers the Board to amend the Health Code and to include in the Health Code all matters to which the authority of the Department extends. Section 1043 grants the Department rulemaking authority. 




[1] NYC Administrative Code § 27-2056.14.

[2] California Health and Safety Code Article 10.1.1.

[3] 2018 Minnesota Statutes § 325E.389.

 
 
Effective Date: 
Sat, 07/20/2019

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

Agency:
Comment By: 
Monday, July 22, 2019
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 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.

 
 
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.

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

Svetlana Burdeynik at (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 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 Board is amending Health Code Articles 11 and 13 as follows:

Hepatitis B Reporting

The Board is amending Health Code §13.03(b)(3)(B) (previously §13.03(b)(3)(A)) to require laboratories to report all hepatitis B virus (HBV) DNA test results, including negative results. The Health Department previously required 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 would have 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.

In consideration of a comment received, the proposed amendment has been modified to exempt blood bank laboratories and other laboratories that perform hepatitis B DNA tests on donated blood from the requirement to report negative and indeterminate hepatitis B DNA test results for such donated blood.

Carbapenem-resistant Enterobacteriaceae Reporting

The Board is amending 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 resistant 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 CRE 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 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 being made for purposes of consistency.

 

Statutory Authority

The Board’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 Board 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/.

Effective Date: 
Wed, 04/18/2018

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