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Proposed Rules: Open to Comments

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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

Proposed Rules: Closed to Comments

Agency:
Comment By: 
Tuesday, October 25, 2016
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 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 Department is proposing that the Board amend Health Code Articles 11 and 13 as follows:

Hepatitis D and E and Other Suspected Infectious Viral Hepatitides Reporting

The Department is requesting that the Board remove hepatitis D and E and “other suspected infectious viral hepatitides” from Health Code §11.03(a)’s list of reportable diseases and amend §13.03(b)(3), regarding reportable laboratory findings, to remove references to these infections. 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 Department is requesting that the Board amend 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 Department is requesting that the Board amend 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, the Department is requesting that §13.03(b)(1) of the Health Code, regarding laboratory reporting of tuberculosis, be 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 laboratory 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

            The Department is requesting that Health Code §11.07(a)(3) be 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 Department is requesting that the Board amend 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. 

Syphilis Testing and Reporting

The Department is requesting that the Board amend 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 will provide for more complete reporting.

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 were made to simplify and clarify §13.03(b)(2).

Enteric Disease Testing and Isolate Submission

            The Department is requesting that the Board amend 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 Department is also requesting that laboratories submit all resulting isolates to the Department. For Shiga toxin-producing Escherichia coli (STEC), laboratories would be required to submit Shiga toxin-positive broth and stool or an isolate.

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.

Statement pursuant to Charter §1043

This proposal was not included in the Department’s Regulatory Agenda for FY 2017 in part because of an administrative oversight and in part because the need for the proposal was not known at the time the Regulatory Agenda was promulgated.

 

Subject: 

Proposed resolution to amend Article 11 (Reportable Diseases, 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 14-31
Queens, NY 11101
Contact: 

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

Download Copy of Proposed Rule (.pdf): 

Proposed Rules: Closed to Comments

Agency:
Comment By: 
Tuesday, April 26, 2016
Proposed Rules Content: 
 

Statement of Basis and Purpose

 

Background

 

The Charter provides the Department of Health and Mental Hygiene (the Department) with jurisdiction over all matters concerning health in the City of New York.  The Department conducts disease surveillance and control activities for diseases reportable pursuant to Article 11 of the New York City Health Code (Health Code).  The Department is also required to comply with various provisions of Part 2 of the New York State Sanitary Code, found in Title 10 of the Codes, Rules and Regulations of the State of New York (NYCRR), with respect to control of communicable diseases.

 

“High containment research laboratories” are facilities that store and handle infectious microorganisms or hazardous biological material and operate at biosafety level (BSL) 3 or 4, as defined by the US Centers for Disease Control and Prevention (CDC) and National Institutes for Health (NIH), in Biosafety in Microbiological and Biomedical Laboratories (BMBL), which delineates four BSLs based on the potential risks of working with infectious or hazardous agents.

 

Biosafety level 1 (BSL-1) is the basic level of protection and is appropriate for agents that are not known to cause disease in normal, healthy humans. Biosafety level 2 (BSL-2) is appropriate for handling moderate-risk agents that cause human disease of varying severity by ingestion or through percutaneous or mucous membrane exposure. Biosafety level 3 (BSL-3) is appropriate for agents with a known potential for aerosol transmission, for agents that may cause serious and potentially lethal infections and that are indigenous or exotic in origin. Exotic agents that pose a high individual risk of life-threatening disease by infectious aerosols and for which no treatment is available are restricted to high containment laboratories that meet biosafety level 4 (BSL-4) standards.[1]   

 

  Since 2001, hundreds of new high-containment research laboratories have been established in the United States. According to the U.S. Government Accountability Office (GAO), 1,495 BSL-3 and BSL-4 laboratories were registered with the Federal Select Agent Program (FSAP) in 2010 compared to 415 in 2004. This was considered an under-estimate, because it only addressed laboratories required to register with the FSAP.[2] With respect to those operating in New York City, the Department does not know when such facilities were or are being established, the total number operating in the City at any time, and the hazardous agents they store or handle.

 

Recent laboratory accidents, none of which occurred in New York City, have focused the Department’s attention on this issue. In June and July 2014, CDC disclosed two potentially serious incidents involving H5N1 avian influenza[3] and Bacillus anthracis,[4] the bacterium that causes anthrax. A third incident at CDC involving an Ebola virus sample occurred in December 2014.[5] In 2007, another potentially serious incident occurred at CDC when the main and backup power supplies failed during a lightning storm, shutting down the negative pressure system in a newly constructed, but not yet operational, BSL-4 laboratory.[6]

 

Two incidents in the past two years involving high-containment laboratories further demonstrate the potential public health risks stemming from research conducted in BSL-3 and BSL-4 laboratories. In November 2014, two primates in the Tulane National Primate Research Center were diagnosed with melioidosis, a severe disease of animals and humans caused by a potential biological threat agent, Burkholderia pseudomallei. The strain infecting the animals was identical to the strain used in a Tulane University laboratory registered with the FSAP. In March 2015, CDC and the U.S. Department of Agriculture’s (USDA) Animal Plant Health Inspection Service (APHIS) concluded that a number of biosafety deficiencies could have led to transmission of B. pseudomallei from the laboratory to the animals in the primate center.[7]

 

In May 2015, CDC started an investigation of a report that a U.S. Department of Defense high-containment laboratory might have inadvertently shipped live B. anthracis spores (the causative agent of anthrax) to a laboratory that was anticipating only deactivated spores. Ultimately, CDC concluded that this laboratory unknowingly shipped live B. anthracis spores on 575 separate occasions to laboratories worldwide over the course of a decade.[8]

 

As serious as these incidents have been, of even greater concern have been laboratory incidents over past decades that have caused outbreaks of contagious virus diseases, including smallpox, SARS, and foot and mouth disease.[9] The Department is concerned that an accident in a NYC-based high-containment research laboratory could have catastrophic consequences, given the population density of nearly 70,000 per square mile in Manhattan and the many other areas of high population density throughout the City.

 

Work performed in a BSL-3 or BSL-4 facility would present the greatest potential risk to public health if an incident occurs. Research laboratories that handle biological agents and toxins and hold government contracts or grants are required to adhere to the BMBL. Most, but not all, of the agents that are stored and handled in high-containment research laboratories and that represent potential public health risks are regulated by the FSAP. Federal regulations require reporting of certain incidents involving select agents to the CDC and local, state and federal law enforcement agencies only; timely notification to local public health authorities of these incidents is not always required by the federal regulations. Federal agencies are also constrained from disclosing to local or state health departments which laboratories within a local jurisdiction are registered to handle and work with select agents. The Department has been informed by the CDC that, with the proper safeguards, information identifying the registered laboratories can be made available to the Department.  However, no other information about these laboratories or the biological agents they work with would be regularly available from CDC.  

 

Several federal agencies exercise varying degrees of oversight over academic and private high-containment research laboratories.  CDC and USDA APHIS regulate laboratories working with certain biological agents and toxins that have the potential to pose a severe threat to public health and safety, known as “select agents,” pursuant to 42 CFR Part 73 (CDC regulations), and 9 CFR Part 121 and 7 CFR Part 331 (USDA regulations).

 

According to the GAO, “While some federal agencies do have a mission to track a subset of BSL-3 and -4 laboratories that work with select agents and know the number of those laboratories, no single regulatory agency has specific responsibility for biosafety in all high-containment laboratories in the United States.”6 If a laboratory is not working with a select agent or not operating with government funding or under a government contract, it is not bound by the federal regulatory scheme, and, unless there is applicable state or local law, a laboratory may be totally unregulated.

 

Because of this regulatory structure, the Department does not have a means to know the number of high-containment research laboratories operating in New York City, their location, or the potentially hazardous biological agents that are stored and/or handled within them. Although clinical laboratories hold permits issued by the State Department of Health,[10] non-clinical research laboratories storing and/or handling biological agents are not currently regulated by the City or State.  They do not currently need to hold permits, to notify local authorities of their existence, or to report incidents of public health concern to the Department, such as loss or theft of agents or suspected transmission of diseases caused by agents stored and/or handled in the laboratories. Unless high-containment research laboratories are required to register with the Department, pre-event planning between the Department and laboratories to mitigate the public health risks and to protect public health cannot take place.      

 

Several state and local US jurisdictions currently regulate research laboratories working with biological agents. In 1996, Connecticut, which had already required all laboratories to register and be inspected before conducting any examination, determination, or test, enacted additional reporting requirements specifically applicable to BSL-3 laboratories, requiring reporting of any infection or injury relating to work with such agents or resulting in recommendations that employees or members of the public be tested or monitored for potential public health problems.[11] Since 2002, Maryland has had a Biological Agent Registration Program, which is nearly identical to the FSAP. The Boston Public Health Commission adopted its Biological Laboratory Regulations in 2006. These regulations establish operational biosafety requirements and require permitting, inspections and reporting of human exposures and other incidents to the Commission.  In 2009, Cambridge, Massachusetts adopted biosafety laboratory regulations and formed the Cambridge Biosafety Committee to enforce them. 

 

The Department proposes that the Board amend Article 13 to require registration of and reporting by research laboratories that have BSL-3 and BSL-4 facilities. A registration form will require identification and contact information of owners, operators, and other persons responsible for biosafety and a list of the biological agents stored and/or handled onsite. The amendment will also require immediate reporting by such facilities to the Department of any exposures of persons, losses, thefts, or unintentional releases of such agents so that the Department can, if necessary, investigate and limit public health risks from these agents.  Laboratories that are currently operating solely as clinical laboratories, blood and tissue banks and those that conduct recombinant DNA experiments pursuant to Title 5 of Article 5, or Articles 43-B or 32-A, of the New York Public Health Law would be excluded from these registration and reporting requirements.

 

Statutory Authority

 

These amendments to the Health Code are promulgated pursuant to §§558 and 1043 of the Charter.  Sections 558(b) and (c) of the Charter empower 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 rule-making authority.  Section 556(c)(2) of the Charter authorizes the Department to “supervise the reporting and control of communicable and chronic disease and conditions hazardous to life and health…”

The proposal is as follows:

“Shall” and “must” denote mandatory requirements and may be used interchangeably unless otherwise specified or unless the context clearly indicates otherwise.

 


[1] CDC (US) and NIH (US). Biosafety in Microbiological and Biomedical Laboratories. 5th ed. Washington (DC): Centers for Disease Control and Prevention (US) and National Institutes of Health (US). 2007; 409 p. Available from http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf

[2] GAO (US). High-Containment Laboratories: Assessment of the Nation’s Need is Missing. Washington (DC): Government Accountability Office (US). 2013 Feb 25; 13 p. Report No.: GAO-13-466R. Available from http://www.gao.gov/products/GAO-13-466R

[3] CDC (US). Report on the Inadvertent Cross-Contamination and Shipment of a Laboratory Specimen with Influenza Virus H5N1. 2014 August 15. http://www.cdc.gov/about/pdf/lab-safety/investigationcdch5n1contaminatio...

[4] CDC (US). Report on the Potential Exposure to Anthrax. 2014 July 11. http://www.cdc.gov/about/pdf/lab-safety/Final_Anthrax_Report.pdf

[5] CDC (US). Report on the Potential Exposure to Ebola Virus. 2015 February 4. http://www.cdc.gov/about/pdf/lab-safety/investigation-into-dec-22-2014-c...

[6] Government Accountability Office (US). High Containment Laboratories—National Strategy for Oversight is Needed. Washington (DC):  Government Accountability Office (US); 2009 Sep. 99 p. Report No.: GAO-09-574. Available from http://www.gao.gov/products/GAO-09-574

[7] CDC (US). Conclusion of select agent inquiry into Burkholderia pseudomallei release at Tulane National Primate Research Center. 2015 Mar 13. Available from http://www.cdc.gov/media/releases/2015/s0313-burkholderia-pseudomallei.html

[8] HHS (US). Testimony of Daniel M. Sosin, MD, MPH, FACP, before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives. Review of Department of Defense Anthrax Specimens. 2015 Jul 28. Available from http://docs.house.gov/meetings/IF/IF02/20150728/103816/HHRG-114-IF02-Wst...

[9] Furmanski M. Threatened pandemics and laboratory escapes: self-fulfilling prophecies. Bulletin of the Atomic Scientists. 2014 Mar 31. Available from http://thebulletin.org/threatened-pandemics-and-laboratory-escapes-self-...

[10] See, e.g., New York Public Health Law Article 5-Laboratories.

[11] Conn. Gen. Stat. §19a-31a; Conn. Agencies Regs. §§ 19a-36-A1 to A56.

 

 

Subject: 

Proposed resolution to amend Article 13(Laboratories) of the New York City Health Code, regarding non-clinical laboratories.

Location: 
New York City Department of Health and Mental Hygiene, Gotham Center
42-09 28th Street 14th Floor, Room 3-32
Queens, NY 11101
Contact: 

Svetlana Burdeynik at ph: (347) 396-6078 or resolutioncomments@health.nyc.gov

Download Copy of Proposed Rule (.pdf): 

Adopted Rules: Closed to Comments

Adopted Rules Content: 

 

 

Statement of Basis and Purpose

 

Statutory Authority

 

These amendments to the New York City Health Code (the Health Code) are promulgated pursuant to §§558 and 1043 of the New York City Charter (the Charter).  Sections 558(b) and (c) of the Charter empower the Board of Health (the Board) to amend the Health Code and to include in the Health Code all matters to which the authority of the New York City Department of Health and Mental Hygiene (the Department) extends. Section 1043 grants the Department rule-making authority.  Further, New York State Public Health law §580(3) permits the Department to “enact or enforce additional laws, codes or regulations affecting clinical laboratories…related to the control, prevention or reporting of diseases or medical conditions or to the control or abatement of public health nuisances.”

 

Background

 

The Charter provides the Department with jurisdiction over all matters concerning health in the City of New York.  The Department’s Division of Disease Control conducts disease surveillance and control activities for most of the infectious diseases listed in Article 11 of the New York City Health Code (Health Code). The Department’s Divisions of Epidemiology, Healthcare Access and Improvement, Health Promotion and Disease Prevention and Environmental Health also conduct surveillance and control activities for noninfectious reportable diseases and conditions.  The Department is also required to comply with various provisions of Chapter 1 of the New York State Sanitary Code (the Sanitary Code), found in Title 10 of the Codes, Rules and Regulations of the State of New York (10 NYCRR), with respect to control of communicable diseases.

 

The lists of reportable diseases in the Health Code and Sanitary Code are periodically modified in response to emerging infections and changing priorities for disease surveillance and control.

 

In addition to reportable disease surveillance, the Department has successfully implemented several different and complementary syndromic surveillance systems to improve outbreak detection capacity as well as provide situational awareness of a wide variety of public health conditions, both routinely and during emergencies.

 

Since implementation of the Article 13 requirement that clinical laboratories report electronically (approved by the Board in 2006), the Department has greatly enhanced its capacity for receiving more complete and timely reports on notifiable diseases to monitor disease trends and conduct effective investigations. 

 

To conduct more effective, timely and complete disease surveillance and control, the Board of Health is amending various provisions of Health Code Articles 11 and 13 as follows: 

 

A.     Amend Health Code §11.03(a) to update the current list of reportable diseases:

1)     Change reporting of “Severe Acute Respiratory Syndrome” to “severe or novel coronavirus” – also changed in paragraph (1) of subdivision (b)

2)     Delete reporting requirement for Kawasaki syndrome

3)     Delete  requirement to report “viral and aseptic meningitis” from reporting of meningitis

 

B.     Amend Health Code §11.03(e) to clarify the authority of the Department to obtain information necessary for public health investigations.

 

C.    Amend Health Code §§11.15 and 11.19 to lower the age for exclusion of children with enteric infections in daycare from less than six years of age to less than five years of age.

 

D.    Amend Health Code §11.17 to clarify Department authority to order health care providers, hospitals and other medical facilities to isolate individuals with certain communicable diseases that may pose imminent and significant threats to public health until action can be taken by the Commissioner or designee.

 

E.     Amend Health Code §13.03(a) (1) to add data elements to be included, if known, on all laboratory reports.

 

F.     Amend Health Code §13.03(b)(1) to require reporting of results of all subsequent TB test results (negative or positive) on samples collected within one year from patients with a prior positive acid fast bacilli (AFB) smear or test for M. tuberculosis complex (e.g., culture or nucleic acid amplification [NAA]).

 

G.    Amend Health Code §13.03(b)(3) to require reporting of all hepatitis B virus (HBV) test results (positive, negative and indeterminate) for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs), both qualitative and quantitative, for children ages 0 days to 1,825 days (birth up to the fifth birthday), when a patient’s age is known. The Department will require only laboratories that electronically submit through the Electronic Clinical Laboratory Reporting System (ECLRS) to report negative HBV laboratory test results through ECLRS. Healthcare providers will not be required to report these results.

 

H.    Amend Health Code §13.03(b)(3) to add to hepatitis C reporting all positive and negative hepatitis C (HCV) nucleic acid tests (NAT) laboratory test results. The Department will require only laboratories that electronically submit through the Electronic Clinical Laboratory Reporting System (ECLRS) to report negative HCV NAT laboratory test results through ECLRS. Blood bank laboratories are exempted from compliance, and healthcare providers will not be required to report these results.

 

I.       Amend Health Code §13.05(b)(1) and add a new paragraph (8) to require reporting of all subsequent TB test results on samples collected within one year from persons with a prior positive AFB smear or positive test for M. tuberculosis complex by culture or NAA .

 

 

Reasons for the changes

 

A)    Changes to the reportable disease list in Health Code §11.03.  Health Code §11.03 (a) and (b) has been amended as follows:

 

1)     Change reporting of “Severe Acute Respiratory Syndrome (SARS)” to “severe or novel coronavirus.” The 2003 epidemic of Severe Acute Respiratory Syndrome (SARS) was due to a novel coronavirus that emerged from mainland China and then spread internationally. In response, the Department added SARS to the list of reportable diseases in Health Code §11.03 to monitor for the re-emergence and potential introduction of this virus into New York City. In 2013, a different coronavirus emerged in the Middle East and resulted in several importations into Europe and hospital outbreaks in both the Middle East and Europe. As of May 16, 2014, there have been 572 confirmed cases, 173 of which were fatal, in 14 countries; this includes two imported cases in the United States. The syndrome caused by this novel coronavirus has been named Middle East Respiratory Syndrome or MERS. To enable the Department to monitor for the introduction of SARS-related, MERS-related, and other novel or severe coronaviruses, the Board has amended “SARS” in §11.03(a) to “severe or novel coronavirus”.  Both suspect and confirmed cases of this disease are listed in Health Code §11.03 (b) (1) as being immediately reportable.

 

2)     Delete Kawasaki syndrome.  Kawasaki syndrome is a rare but serious rash illness that most commonly occurs in children less than 5 years of age. The etiologic agent(s) responsible for Kawasaki syndrome remain unknown despite intensive investigations during prior outbreaks, and the disease does not appear to be spread from person to person. From 2002 to 2012, there has only been a median of 20 cases (range 2 to 35 cases) of Kawasaki syndrome reported in New York City per year. There is no public health response to an individual case other than confirming that the case meets clinical criteria. Kawasaki syndrome is not currently listed as reportable in either the State Sanitary Code or the Centers for Disease Control and Prevention (CDC) National Notifiable Disease Surveillance System. As the Health Code §11.03 (a) requires reporting of suspected or confirmed outbreaks of any disease or condition (defined as 3 or more cases), the Department would still respond to reports of outbreaks of Kawasaki syndrome after it is removed from the list. There is no reason, however, to continue to make individual cases reportable. Therefore, the Board is removing Kawasaki syndrome from the list of reportable diseases.

 

3)     Delete viral and aseptic meningitis.  Viral meningitis is a clinical syndrome that can be caused by a wide variety of viruses, most of which do not represent a public health concern, especially for single cases.  Aseptic meningitis is when a patient has the clinical syndrome of meningitis, but the laboratory identifies no microorganisms. Most cases of aseptic meningitis are due to viruses. Arboviral diseases, including arboviral meningitis, are currently listed and reportable separately in Health Code §11.03 (a) and will remain reportable given the need to monitor for diseases like West Nile virus to ensure prompt detection and control of mosquito borne viruses in New York City. There is no public health response to an individual case for most other causes of viral or aseptic meningitis. For many, the specific etiologic agent remains unknown once more common causes of bacterial or viral meningitis are ruled out by laboratory testing. Neither viral nor aseptic meningitis are currently listed in the CDC’s National Notifiable Disease Surveillance System. The New York State Department of Health has also indicated they intend to request that the State Public Health and Health Planning Council remove this disease from the State Sanitary Code at some time in the future.  However, even if deleted from the Health Code list, until the disease is deleted from the State Sanitary Code, it will remain reportable in New York City. Lastly, as Health Code §11.03(a) requires reporting of suspected or confirmed outbreaks of any disease or condition (defined as 3 or more cases), the Department would still respond to clusters of viral or aseptic meningitis even after this disease is removed from the list. Therefore, the Department is requesting the Board remove viral and aseptic meningitis from the list of reportable diseases.

 

B)    Amend Health Code §11.03(e) to clarify the Department’s authority to obtain medical information for public health investigations. Currently, this provision authorizes the Department to obtain additional information concerning any report made by required reporters listed in Health Code §11.05(a) or other individuals required to submit reports in accordance with other applicable law. However, this limits the Department’s authority to obtain information necessary for public health investigations when information about a public health problem originates not with a required reporter of a case or condition, but with other individuals or entities. In dangerous dog investigations, for example, the health care provider treating the bite victim is required to report the bite pursuant to Health Code §11.03(a) and (e). However, other sources may also report on the bites, such as the person bitten, the owner of the dog, a police officer, a bystander, or local media.  In the course of such an investigation, the Department may learn about other bites inflicted by a particular dog that were not reported by a treating health care provider. Medical information about the other bite victim’s injuries is also vital to such an investigation. As currently drafted, §11.03(e) could limit the ability of the Department to obtain necessary medical information regardless of whether the case was reported in accordance with §11.03(a). The Board is amending this provision to clarify its authority to obtain necessary medical information for public health investigations. Although New York City Charter §555 (b) authorizes the Commissioner to issue subpoenas to compel production of witnesses, records, and other documents in any proceeding before the Commissioner, there are so many reported diseases and conditions being investigated at any one time, that requiring subpoenas to be issued is unnecessarily cumbersome. It should also be noted that HIPAA authorizes disclosure of medical information for public health purposes to public health agencies, such as the Department, without patient consent. In most reportable disease and condition investigations, it is important to be able to investigate and intervene appropriately, based on the best available information, as quickly as possible to prevent further transmission of a communicable disease or injuries from poisonings or other conditions the Department has the duty to investigate.   

 

Another reason to amend this provision is the emergence of organizations that manage the exchange of health information in a defined geographic area for outpatient clinics, provider offices, hospitals, laboratories, and other healthcare entities, currently referred to as regional health information organizations (RHIOs) or Qualified Entities (QEs). With the increasing use of electronic health records and health information exchanges, the Department recognizes health information exchange organizations as potential sources of information necessary for investigations of reportable diseases and conditions listed in Health Code §11.03.  Accordingly, the Board is adding a requirement to §11.03(e) that affords the Department access to electronically stored patient health information by entities such as health information exchange organizations for any confirmed or suspected cases, contacts, or carriers of reportable diseases that is necessary for the Department to conduct its surveillance and epidemiologic investigations, including in response to suspected or confirmed outbreaks. 

 

C)    Amend Health Code §§11.15 and 11.19 to change the age of exclusion for children with enteric infections in daycare and pre-kindergarten from under six years of age to under five years of age. Health Code §11.15 currently requires exclusion of a child under the age of six or staff member who has contact with children under the age of six in a school, day care facility, camp, or other congregate care setting who has been diagnosed with one of the following gastrointestinal illnesses: amebiasis, Campylobacteriosis, cholera, Cryptosporidiosis, E. coli O15:H7 or other Shiga toxin producing Escherichia coli (STEC) infections, Giardiasis, Hepatitis A, Paratyphoid fever, Salmonellosis (other than typhoid), Shigellosis, Typhoid fever, and Yersiniosis.

 

Age criteria are being lowered from under six to under five years, so that control efforts are focused on the children at highest risk in daycare or pre-kindergarten settings. Outbreaks or person-to-person spread are much less common among children who are toilet trained and no longer require diaper care.  Excluding children from kindergarten requires children to miss educational services and a parent or caregiver to stay home from work creating a significant burden for families.  Changing the threshold from under 6 years to under 5 years will allow the Department to focus enforcement efforts in children attending daycare or pre-kindergarten settings, and not children attending kindergarten or elementary school where the risk of disease transmission is less.  For the same reasons, Health Code §11.19 (a) and (b) are being amended with regard to exclusion of children under age five  who are  cases of paratyphoid and typhoid fever or staff persons in institutions or schools who are such cases and who may have contact with children under age five.

 

D)    Amend Health Code §11.17 to clarify the Department’s authority to order the isolation of persons with communicable diseases that may pose an imminent and significant threat to public health. Subdivision (a) of Health Code §11.17 (Control measures; duty to isolate; and isolation, quarantine and examination orders) requires that suspected or confirmed cases and carriers of specific contagious infectious diseases and “any other contagious disease that in the opinion of the Commissioner may pose an imminent and significant threat to the public health … shall be isolated in a manner consistent with recognized infection control principles and isolation procedures in accordance with State Department of Health regulations or guidelines.” The Health Code provision does not explicitly impose a duty upon the physicians attending these cases or carriers to isolate them until the Commissioner or designee takes further action. The proposed amendment clarifies that physicians attending to these patients are required to isolate them.    

 

A similar provision in the State Sanitary Code §2.27 imposes a duty upon attending physicians to isolate persons with “highly communicable diseases,” pending public health action. It refers to Sanitary Code §2.1 for a definition of “highly communicable diseases.”  However, Sanitary Code §2.1 lists only certain reportable diseases and does not indicate that there may be other emergent diseases of public health concern that are not listed. The amendment to Health Code §11.17(a) clarifies that physicians, hospitals, and other medical facilities attending patients with diseases listed in Health Code §11.17, as well as those with emergent diseases that are not currently reportable but are of public health concern, are also required to isolate them pending further action by the Department.

 

E)    Amend Health Code §13.03(a) to require additional data elements to be submitted with electronic laboratory reports of notifiable diseases and conditions. Electronic laboratory reporting has greatly improved the timeliness and completeness of reportable disease surveillance. As more health care information is now available with enhancements and improved linkages in electronic health record systems, it is possible to obtain more complete information on the case-patient and the health care provider who requested testing to facilitate case investigations. The Board is adding the following data elements to the list of information that should accompany all electronic laboratory reports, if known, in Health Code §13.03: 

 

Patient email

Patient mobile phone number

Provider email

Provider fax number

Provider mobile phone number

Provider National Provider Identification (NPI) number

Facility National Provider Identification (NPI) number

 

In addition, paragraph (1) of Health Code §13.03(a) currently requires the pregnancy status to be indicated if known and if clinically relevant (e.g., for hepatitis B and syphilis).  Although the laboratory may not know the patient’s pregnancy status based on information provided by the requesting health care provider, the laboratory would know that a pre-natal panel of laboratory tests was ordered. Therefore, this provision only applies to situations in which  pregnancy status is known and indicated or when pregnancy is probable (e.g., a pre-natal panel is ordered).

  

These additional data elements will enhance the Department’s disease surveillance efforts by improving its ability to contact patients and/or providers to obtain additional information required for a case investigation.

 

F)     Amend Health Code §13.03(b)(1) and §13.05 to require reporting of all tuberculosis test results of subsequent samples for patients with either an initial positive acid fast bacilli (AFB) smear or positive culture or other test for M. tuberculosis complex. Health Code §13.03(b)(1) is being amended to require the reporting of all subsequent test results for a patient within one year of a previous positive test result for AFB smear, nucleic acid amplification (NAA), mycobacterial culture, or other test for M. tuberculosis complex. Currently negative results are only reported when results are from samples with an AFB positive smear. This amendment will enable the Department to more quickly rule out a suspected diagnosis of TB and discontinue unnecessary treatment and to better monitor treatment.

 

Cases and suspect cases of TB disease residing in New York City are managed by the Department, sometimes in partnership with private providers. Currently, laboratories are required to report to DOHMH all results from biological samples found positive for AFB, cultures and NAA tests positive for M. tuberculosis complex, drug susceptibility tests performed on M. tuberculosis complex cultures, pathology findings indicative of TB, and any culture or NAA result associated with an AFB-positive smear sample even if negative. Current reporting is not, however, timely enough to identify persons who were suspected as having TB, started treatment, and later found not to have TB disease, nor is it adequate enough to track TB patients’ response to treatment.

 

Test results on initial samples collected from patients are used to diagnose TB disease and determine infectiousness. Test results from subsequent samples collected after an initial positive sample are used to monitor a patient’s response to treatment. Receiving timely test results, either positive or negative, is critical for these purposes.

 

Current required test results are reported electronically or via fax to the Department when they become available. To obtain negative test results that are not currently reportable, Department staff must visit hospitals to perform chart reviews and visit or call providers and laboratories. Getting a negative result can take multiple attempts over months. Patients suspected of TB are placed on treatment until TB diagnosis is ruled out, which is generally based on laboratory test results. Reducing the time to obtain negative test results can reduce the time the patient is on unnecessary treatment. More importantly, negative results are critical for monitoring patients on treatment. In general, patients on appropriate treatment are expected to have negative culture results within 60 days of treatment. Extending treatment may be necessary if patients do not have a documented negative culture conversion. Having negative results automatically reported to the Department will decrease the time it takes for patients to be deemed non-infectious and will assist the Department in determining the optimal treatment length for TB patients.

 

G)  Amend Health code §13.03(b)(3) to require reporting of negative hepatitis B virus (HBV) test results for children for children ages 168 days to 1,825 days (six months of age up to the fifth birthday). The addition of required reporting of HBsAg (hepatitis B surface antigen) and anti-HBs (hepatitis B surface antibody) test results for children up to five years of age, when the child’s age is known, will support the Department’s efforts to help prevent perinatal HBV among children born to HBV-infected mothers and to conduct surveillance for this nationally notifiable disease. Children born to HBV-infected mothers are at high risk of acquiring this infection. If infected, 90% will develop chronic hepatitis infection, placing them at risk for cirrhosis and hepatic carcinoma at an early age.

 

Each year, the Department case manages approximately 1,800 babies born to HBV positive pregnant women in New York City. Through individual patient education and case management, the Department helps to ensure that the newborns receive HBV immune globulin and HBV vaccine within 12 hours of birth and two more doses of HBV vaccine by six months of age to prevent HBV infection. These high-risk children should have post-vaccination serology testing performed at nine months of age to assess if they are infected, susceptible, or immune. Interpretation requires the test results for both HBsAg and anti-HBs. Children who are found to be infected have to be referred to a specialist for evaluation and treatment.  Children who are found susceptible after the first immunization series have to immediately begin a second three dose series of HBV vaccination.

 

Currently, the Department contacts the pediatric provider who administered the HBV vaccinations to provide reminders and to obtain post-vaccination serology testing results. This activity consumes approximately 25% of staff time. In addition, the Department is frequently unable to obtain all test results due to not being able to locate the family or the pediatric provider. The Department does not obtain test results for approximately 40% of the 1,800 babies managed annually. By requiring reporting of all test results for HBsAg and anti-HBs for children up to five years, the Department will receive post-vaccination serology test results more efficiently and completely. The Department will be better able to manage cases lost to follow-up either by the Department or by other health jurisdictions, which may have cases that have moved to New York City.

 

H)  Amend Health code §13.03(b)(3) to require reporting of negative hepatitis C virus (HCV) nucleic acid tests (NAT) (electronic laboratory reporting only). The Department is proposing that the Board amend Health Code §13.03(b)(3) to require reporting of all HCV NAT results. This provision currently specifies only that HCV (and other hepatitis) reports made by clinical laboratories be accompanied by results of alanine aminotransferase testing (ALT). The addition of required reporting of NAT results will support the Department’s 2013 HCV strategic plan[1] to reduce illness and death from HCV. One component of this plan involves strengthening the Department’s capacity to manage and utilize data for evidence-based policies and practice. By receiving reports of both positive and negative test results for HCV NAT, the Department will be able to estimate the number of persons tested, the burden of chronic HCV infection in New York City, the number of persons treated for and cured of chronic HCV infection, and monitor changes over time, similar to what is currently authorized for human immunodeficiency virus (HIV) infection.

 

As many as 146,500 New York City residents may have chronic HCV. The disease is most prevalent in New York City neighborhoods with high poverty. Most persons living with HCV have few symptoms of illness until 10 to 30 years after initial infection, when life-threatening health complications, including cirrhosis and liver cancer, can develop. The annual number of deaths associated with HCV has been increasing yearly and, since 2007, has exceeded deaths associated with HIV in the United States. Highly effective HCV antiviral treatments have recently been approved, and more are expected in the coming years, making it likely that liver failure, cancer, and death from HCV can be averted in the future.

 

Antibody screening tests for HCV are recommended for all persons born between 1945 and 1965 and for patients with risk factors, including any history of injection drug use or receipt of a blood transfusion before 1992. However, 15-25% of patients who test HCV antibody positive have no detectable HCV nucleic acid in their blood, indicating that they do not have HCV infection. This is usually because they either resolved a prior HCV infection or had a false-positive HCV antibody test. Therefore, it is recommended that all patients with a positive HCV antibody test undergo HCV NAT testing to determine infection status.

 

The Department found that, from 2009 to 2012, 27% of patients with a positive HCV antibody never received an HCV NAT test, while an additional 9% only received NAT testing after the Department sent a reminder to the clinician that NAT testing is recommended.

 

Currently, both the Sanitary Code and Health Code §11.03 mandate reporting by health care providers and others of persons who are cases and carriers of HCV.  Laboratories must report positive HCV antibody screening tests and all positive confirmatory assays, e.g., recombinant immunoblot assay (RIBA) or NAT, that result from laboratory analysis of specimens in accordance with the “Laboratory Reporting of Communicable Diseases, 2010” guidance issued by the Department and the New York State Department of Health.  With nearly 10,000 new cases of HCV reported each year, the Department does not currently have sufficient staff resources to conduct individual case investigations by chart review and patient and provider interviews to determine infection and treatment status.  If the Department received results of both positive and negative tests for HCV NAT, this would provide more useful information for tracking the HCV epidemic in New York City. First, it would be possible to accurately classify patients as chronically infected by determining which antibody-positive patients are infected (NAT positive) versus not infected (NAT negative). Second, it would be possible to evaluate HCV testing patterns and focus outreach efforts toward providers who are not following HCV NAT testing recommendations. Third, by making all HCV NAT results reportable, the Department would also be able to estimate the proportion of patients who are receiving care for their diagnosis. For example, patients with only an antibody test but no NAT test would presumably not be in care. Patients who are NAT positive, but become NAT negative over time, would be presumed to be on treatment and, if the negative NAT tests are sustained, to be cured. The Department would be able to use these data to target interventions to those neighborhoods that have persistently higher levels of HCV viral loads based on HCV NAT results. These data could also be used to identify and prioritize linkage to care for persons who have been diagnosed with chronic HCV but have been lost to medical follow-up. Finally, these data will help the Department evaluate and, as needed, enhance our policies and programs on HCV prevention and control.

 

Accordingly, a new requirement has been added for laboratories to report negative HCV NAT test results through the Department’s electronic reporting mechanism set forth in Health Code §13.03(c). Blood bank laboratories are exempt from compliance with this requirement  because they perform large numbers of HCV NAT tests on persons who do not have positive HCV antibody test results. DOHMH is only interested in collecting negative HCV NAT results for persons with a prior positive test for HCV antibody.

 

 

 




[1] Hepatitis C in New York City: State of the Epidemic and Action Plan.  Available at http://www.nyc.gov/html/doh/downloads/pdf/cd/hepC-action-plan.pdf

 

Effective Date: 
Mon, 07/21/2014

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

Agency:
Comment By: 
Wednesday, April 23, 2014
Proposed Rules Content: 

Statement of Basis and Purpose

 

Statutory Authority

 

These amendments to the New York City Health Code (the Health Code) are promulgated pursuant to §§558 and 1043 of the New York City Charter (the Charter).  Sections 558(b) and (c) of the Charter empower the Board of Health (the Board) to amend the Health Code and to include in the Health Code all matters to which the authority of the New York City Department of Health and Mental Hygiene (the Department) extends. Section 1043 grants the Department rule-making authority.  Further, New York State Public Health law §580(3) permits the Department to “enact or enforce additional laws, codes or regulations affecting clinical laboratories…related to the control, prevention or reporting of diseases or medical conditions or to the control or abatement of public health nuisances.”

 

Background

 

The Charter provides the Department with jurisdiction over all matters concerning health in the City of New York.  The Department’s Division of Disease Control conducts disease surveillance and control activities for most of the diseases listed in Article 11 of the New York City Health Code (Health Code). The Department’s Divisions of Epidemiology, Healthcare Access and Improvement, Health Promotion and Disease Prevention, and Environmental Health also conduct surveillance and control activities for various reportable diseases and conditions.  The Department is also required to comply with various provisions of Chapter 1 of the New York State Sanitary Code (the Sanitary Code), found in Title 10 of the Codes, Rules and Regulations of the State of New York (NYCRR), with respect to control of communicable diseases.

 

The lists of reportable diseases in the Health Code and Sanitary Code are periodically modified in response to emerging infections and changing priorities for disease surveillance and control.

 

In addition to reportable disease surveillance, the Department has successfully implemented several different and complementary syndromic surveillance systems to improve outbreak detection capacity as well as provide situational awareness of a wide variety of public health conditions, both routinely and during emergencies.

Since implementation of the Article 13 requirement that clinical laboratories report electronically (approved by the Board in 2006), the Department has greatly enhanced its capacity for receiving more complete and timely reports on notifiable diseases to monitor disease trends and conduct effective investigations. 

 

To conduct more effective, timely and complete disease surveillance and control, the Department is proposing that the Board of Health amend various provisions of Health Code Articles 11 and 13 as follows: 

 

A.     Amend Health Code § 11.03(a) to update the current list of reportable diseases:

1)     Change reporting of “Severe Acute Respiratory Syndrome” to “severe or novel coronavirus” – also changed in paragraph (1) of subdivision (b)

2)     Delete reporting requirement for Kawasaki syndrome

3)     Delete  requirement to report “viral and aseptic meningitis” from reporting of meningitis

 

B.     Amend Health Code § 11.03(d) to add pharmacy sales of both prescription and over the counter medications as new sources for syndromic surveillance.

 

C.    Amend Health Code §11.03(e) to clarify the authority of the Department to obtain information necessary for public health investigations.

 

D.    Amend Health Code §§11.15 and 11.19 to lower the age for exclusion of children with enteric infections in daycare from less than six years of age to less than five years of age.

 

E.     Amend Health Code § 11.17 to clarify Department authority to order health care providers to  isolate individuals with certain communicable diseases that may pose imminent and significant threats to public health until action can be taken by the Commissioner or designee.

 

F.     Amend Health Code §13.03(a) (1) to add data elements to be included on all laboratory reports.

 

G.    Amend Health Code §13.03(b)(1) to require reporting of results of all TB tests  (negative or positive) of subsequent samples from patients with a prior positive acid fast bacilli (AFB) smear or test for M. tuberculosis complex (e.g., culture or nucleic acid amplification [NAA]).

 

H.    Amend Health Code § 13.03(b)(3) to add to hepatitis C reporting all positive and negative hepatitis C (HCV) nucleic acid tests (NAT) laboratory test results. The Department will require only laboratories that electronically submit through the Electronic Clinical Laboratory Reporting System (ECLRS) to report negative HCV NAT laboratory test results through ECLRS. Healthcare providers will not be required to report these results.

 

I.       Amend Health Code § 13.03(b)(3) to require reporting of all hepatitis B virus (HBV) test results (positive, negative and indeterminate) for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs), both qualitative and quantitative, for children ages 168 days to 1,825 days (six months of age up to the fifth birthday). The Department will require only laboratories that electronically submit through the Electronic Clinical Laboratory Reporting System (ECLRS) to report negative HBV laboratory test results through ECLRS. Healthcare providers will not be required to report these results.

 

J.      Amend Health Code § 13.05(b)(1) and add a new paragraph (8)to require reporting of results of all subsequent tests on specimens from persons with a prior positive AFB smear or positive test for M. tuberculosis complex by culture or NAA .

 

Reasons for these changes

 

A)    Changes to the reportable disease list in Health Code §11.03.  The Department is requesting the Board to amend Health Code §11.03 (a) and (b) as follows:

 

1)     Change reporting of “Severe Acute Respiratory Syndrome (SARS)” to “severe or novel coronavirus.” The 2003 epidemic of Severe Acute Respiratory Syndrome (SARS) was due to a novel coronavirus that emerged from mainland China and then spread internationally. In response, the Department added SARS to the list of reportable diseases in Health Code §11.03 to monitor for the re-emergence and potential introduction of this virus into New York City. In 2013, a different coronavirus emerged in the Middle East and resulted in several importations into Europe and hospital outbreaks in both the Middle East and Europe. As of February 7, 2014, there have been 182 cases, including 79 deaths worldwide.  The syndrome caused by this novel coronavirus has been named Middle East Respiratory Syndrome or MERS. To enable the Department to monitor for the introduction of SARS-related, MERS-related, and other novel or severe coronaviruses, the Department is requesting the Board to change “SARS” in §11.03(a) to “severe or novel coronavirus”.  Both suspect and confirmed cases of this disease will also be listed in Health Code § 11.03 (b) (1) as being immediately reportable.

 

2)     Delete Kawasaki syndrome.  Kawasaki syndrome is a rare but serious rash illness that most commonly occurs in children less than 5 years of age. The etiologic agent(s) responsible for Kawasaki syndrome remain unknown despite intensive investigations during prior outbreaks, and the disease does not appear to be spread from person to person. From 2002 to 2012, there has only been a median of 20 cases (range 2 to 35 cases) of Kawasaki syndrome reported in New York City per year. There is no public health response to an individual case other than confirming that the case meets clinical criteria. Kawasaki syndrome is not currently listed as reportable in either the State Sanitary Code or the Centers for Disease Control and Prevention (CDC) National Notifiable Disease Surveillance System. As the Health Code § 11.03 (a) requires reporting of suspected or confirmed outbreaks of any disease or condition (defined as 3 or more cases), the Department would still respond to reports of outbreaks of Kawasaki syndrome after it is removed from the list. There is no reason, however, to continue to make individual cases reportable. Therefore, the Department is requesting the Board to remove Kawasaki syndrome from the list of reportable diseases.

 

3)     Delete viral and aseptic meningitis.  Viral meningitis is a clinical syndrome that can be caused by a wide variety of viruses, most of which do not represent a public health concern, especially for single cases.  Aseptic meningitis is when a patient has the clinical syndrome of meningitis, but the laboratory identifies no microorganisms. Most cases of aseptic meningitis are due to viruses.  Arboviral diseases, including arboviral meningitis, are currently listed and reportable separately in Health Code § 11.03 (a) and will remain reportable given the need to monitor for diseases like West Nile virus to ensure prompt detection and control of mosquito borne viruses in New York City. There is no public health response to an individual case for most other causes of viral or aseptic meningitis. For many, the specific etiologic agent remains unknown once more common causes of bacterial or viral meningitis are ruled out by laboratory testing. Neither viral nor aseptic meningitis are currently listed in the CDC’s National Notifiable Disease Surveillance System. The New York State Department of Health has also indicated they intend to request that the State Public Health and Health Planning Council remove this disease from the State Sanitary Code at some time in the future.  However, even if deleted from the Health Code list, until the disease is deleted from the State Sanitary Code, it will remain reportable in New York City.  Lastly, as Health Code §11.03(a) requires reporting of suspected or confirmed outbreaks of any disease or condition (defined as 3 or more cases), the Department would still respond to clusters of viral or aseptic meningitis even after this disease is removed from the list. Therefore, the Department is requesting the Board to remove viral and aseptic meningitis from the list of reportable diseases.

 

B)    Amend Health Code §11.03 (d) adding pharmaceutical sales to the types of data that may be collected in conducting syndromic surveillance.  In 2008, the Board adopted Health Code 11.03(d), authorizing the Department to collect and monitor certain types of de-identified electronic health care data (e.g., emergency department and clinic visits) to ascertain the existence of and monitor the progress of an outbreak. This type of surveillance, known commonly as “syndromic surveillance,” relies on a wide array of electronic data sources and analytical techniques. Emergency department visit logs and over-the-counter pharmacy sales are examples of health encounter data sources that are routinely collected, available in electronic format, and able to be transmitted in a timely manner for public health monitoring. The Department has been using syndromic surveillance in various formats for the past 12 years as a complement to traditional notifiable disease surveillance to monitor for public health conditions, including seasonal surveillance for influenza-like illness, gastroenteritis, and injuries and mental health issues during and after emergencies (e.g., Hurricane Sandy in 2012).

 

Since 2002, the Department has received data on pharmaceutical sales on a voluntary basis from a large retail chain in New York City. In 2013, a second pharmacy chain was added to the Department’s system, again on a voluntary basis. The Department recognizes the additional value that pharmacy sales data provide to the other syndromic data sources currently listed in Health Code § 11.03(d). Pharmacies may be the first and only contact with the health care system for individuals with early or mild symptoms of disease, and pharmaceutical sales data have demonstrated usefulness in outbreak detection.  One example was a marked increase in sales of over-the-counter antidiarrheal medication that was retrospectively recognized as one of the first indicators of a large outbreak of cryptosporidiosis in Milwaukee in 1993 due to contamination of the municipal water supply.[1] In August 2003, the Department used syndromic pharmacy data to detect an increase in diarrheal illness associated with a citywide power outage.[2]

 

Accordingly, the Department is proposing that the Board add retail pharmacies to the list of facilities in Health Code § 11.03(d) from which reports will be required and to list both over-the-counter and prescription medications as data elements that will be requested. Such reports must be made electronically and in a form, manner, and frequency as specified by the Department. The data collected will not include any personal identifiers.  Specific variables that will be requested from pharmacies include, but may not be limited to, the following:  date of sale, product name, National Drug Code, store address/zip code, store ID, quantity/size, birth year of purchaser (prescription drug only), promotion item and Universal Product Code (over the counter medications only). Pharmacies not equipped to maintain sales data electronically will be exempted from this requirement. It should be noted that Health Code §71.09 currently makes pharmacies’ and other entities’ records subject to inspection by the Department in connection with public health investigations and provides that all information obtained from such records is to be kept confidential by the Department.

 

C)    Amend Health Code §11.03(e) to clarify the Department’s authority to obtain medical information for public health investigations.  Currently, this provision authorizes the Department to obtain additional information concerning any report made by required reporters listed in Health Code §11.05(a) or other individuals required to submit reports in accordance with other applicable law. However, this limits the Department’s authority to obtain information necessary for public health investigations when information about a public health problem originates not with a required reporter of a case or condition, but with other individuals or entities.  In dangerous dog investigations, for example, the health care provider treating the bite victim is required to report the bite pursuant to Health Code §11.03(a) and (e). However, other sources may also report on the bites, such as the person bitten, the owner of the dog, a police officer, a bystander, or local media.  In the course of such an investigation, the Department may learn about other bites inflicted by a particular dog that were not reported by a treating health care provider.  Medical information about the other bite victim’s injuries is also vital to such an investigation. As currently drafted, §11.03(e) could limit the ability of the Department to obtain necessary medical information regardless of whether the case was reported in accordance with §11.03(a). The Department is proposing that the Board amend this provision to clarify its authority to obtain necessary medical information for public health investigations. Although New York City Charter §555 (b) authorizes the Commissioner to issue subpoenas to compel production of witnesses, records, and other documents in any proceeding before the Commissioner, there are so many reported diseases and conditions being investigated at any one time, that requiring subpoenas to be issued is unnecessarily cumbersome. It should also be noted that HIPAA authorizes disclosure of medical information for public health purposes to public health agencies, such as the Department, without patient consent.  In most reportable disease and condition investigations, it is important to be able to investigate and intervene appropriately, based on the best available information, as quickly as possible to prevent further transmission of a communicable disease or injuries from poisonings or other conditions the Department has the duty to investigate.   

 

Another reason to amend this provision is the emergence of organizations that manage the exchange of health information in a defined geographic area for outpatient clinics, provider offices, hospitals, laboratories, and other healthcare entities, currently referred to as regional health information organizations (RHIOs) or Qualified Entities (QEs). With the increasing use of electronic health records and health information exchanges, the Department recognizes health information exchange organizations as potential sources of information necessary for investigations of reportable diseases and conditions listed in Health Code §11.03.  Accordingly, the Department is requesting the Board to add a requirement to §11.03(e) that affords the Department access to electronically stored patient health information by entities such as health information exchange organizations for any confirmed or suspected cases, contacts, or carriers of reportable diseases that is necessary for the Department to conduct its surveillance and epidemiologic investigations, including in response to suspected or confirmed outbreaks. 

 

D)    Amend Health Code §§11.15 and 11.19 to change the age of exclusion for children with enteric infections in daycare and pre-kindergarten from under six years of age to under five years of age. Health Code §11.15 currently requires exclusion of a child under the age of six or staff member who has contact with children under the age of six in a school, day care facility, camp, or other congregate care setting who has been diagnosed with one of the following gastrointestinal illnesses: amebiasis, Campylobacteriosis, cholera, Cryptosporidiosis, E. coli O15:H7 or other Shiga toxin producing Escherichia coli (STEC) infections, Giardiasis, Hepatitis A, Paratyphoid fever, Salmonellosis (other than typhoid), Shigellosis, Typhoid fever, and Yersiniosis.

 

The Department is proposing that the Board lower the age criteria from under six to under five years, so that control efforts are focused on the children at highest risk in daycare or pre-kindergarten settings. Outbreaks or person-to-person spread are much less common among children who are toilet trained and no longer require diaper care.  Excluding children from kindergarten requires children to miss educational services and a parent or caregiver to stay home from work creating a significant burden for families.  Changing the threshold from under 6 years to under 5 years will allow the Department to focus enforcement efforts in children attending daycare or pre-kindergarten settings, and not children attending kindergarten or elementary school where the risk of disease transmission is less.  For the same reasons, the Department is proposing that the change in excluding children only under age five also be made applicable to cases of paratyphoid and typhoid fever in §11.19.

 

E)    Amend Health Code § 11.17 to clarify the Department’s authority to order the isolation of persons with communicable diseases that may pose an imminent and significant threat to public health. Subdivision (a) of Health Code §11.17 (Control measures; duty to isolate; and isolation, quarantine and examination orders) requires that suspected or confirmed cases and carriers of specific contagious infectious diseases and “any other contagious disease that in the opinion of the Commissioner may pose an imminent and significant threat to the public health … shall be isolated in a manner consistent with recognized infection control principles and isolation procedures in accordance with State Department of Health regulations or guidelines.” The Health Code provision does not explicitly impose a duty upon the physicians attending these cases or carriers to isolate them until the Commissioner or designee takes further action. The proposed amendment clarifies that physicians attending to these patients are required to isolate them.    

 

A similar provision in the State Sanitary Code § 2.27 imposes a duty upon attending physicians to isolate persons with “highly communicable diseases,” pending public health action. It refers to Sanitary Code § 2.1 for a definition of “highly communicable diseases.”  However, Sanitary Code § 2.1 lists only certain reportable diseases and does not indicate that there may be other emergent diseases of public health concern that are not listed. The proposed amendment to Health Code § 11.17(a) will clarify that physicians attending patients with diseases listed in Health Code § 11.17, as well as those with emergent diseases that are not currently reportable, are required to isolate them pending further action by the Department.

 

 

F)     Amend Health Code §13.03(a) to require additional data elements to be submitted with electronic laboratory reports of notifiable diseases and conditions. Electronic laboratory reporting has greatly improved the timeliness and completeness of reportable disease surveillance. As more health care information is now available with enhancements and improved linkages in electronic health record systems, it is possible to obtain more complete information on the case-patient and the health care provider who requested testing to facilitate case investigations. The Department is requesting that the Board add the following data elements to the list of information that should accompany all electronic laboratory reports, if known, in Health Code §13.03: 

 

Patient email

Patient mobile phone number

Provider email

Provider fax number

Provider mobile phone number

Provider National Provider Identification (NPI) number

Facility National Provider Identification (NPI) number

 

In addition, paragraph (1) of Health Code §13.03(a) currently requires the pregnancy status to be indicated if known and if clinically relevant (e.g., for hepatitis B and syphilis).  Although the laboratory may not know the patient’s pregnancy status based on information provided by the requesting health care provider, the laboratory would know that a pre-natal panel of laboratory tests was ordered. Therefore, the Department is proposing to amend this provision to require information about pregnancy either when pregnancy status is known and indicated or when pregnancy is probable (e.g., a pre-natal panel is ordered).

  

These additional data elements will enhance the Department’s disease surveillance efforts by improving its ability to contact patients and/or providers to obtain additional information required for a case investigation.

 

G)    Amend Health Code §13.03(b)(1) and §13.05 to require reporting of all tuberculosis test results of subsequent samples for patients with either an initial positive acid fast bacilli (AFB) smear or positive culture or other test for M. tuberculosis complex. The Department is proposing that the Board amend Health Code §13.03(b)(1) to require the reporting of all subsequent test results for a patient with a previous positive test result for AFB smear, nucleic acid amplification (NAA), mycobacterial culture, or other test for M. tuberculosis complex. Currently negative results are only reported when results are from samples with an AFB positive smear. This amendment will enable the Department to more quickly rule out a suspected diagnosis of TB and discontinue unnecessary treatment and to better monitor treatment.

 

Cases and suspect cases of TB disease residing in New York City are managed by the Department, sometimes in partnership with private providers. Currently, laboratories are required to report to DOHMH all results from biological samples found positive for AFB, cultures and NAA tests positive for M. tuberculosis complex, drug susceptibility tests performed on M. tuberculosis complex cultures, pathology findings indicative of TB, and any culture or NAA result associated with an AFB-positive smear sample even if negative. Current reporting is not, however, timely enough to identify persons who were suspected as having TB, started treatment, and later found not to have TB disease, nor is it adequate enough to track TB patients ’ response to treatment.

 

Test results on initial samples collected from patients are used to diagnose TB disease and determine infectiousness. Test results from subsequent samples collected after an initial positive sample are used to monitor a patient’s response to treatment. Receiving timely test results, either positive or negative, is critical for these purposes.

 

Current required test results are reported electronically or via fax to the Department when they become available. To obtain negative test results that are not currently reportable, Department staff must visit hospitals to perform chart reviews and visit or call providers and laboratories. Getting a negative result can take multiple attempts over months. Patients suspected of TB are placed on treatment until TB diagnosis is ruled out, which is generally based on laboratory test results. Reducing the time to obtain negative test results can reduce the time the patient is on unnecessary treatment. More importantly, negative results are critical for monitoring patients on treatment. In general, patients on appropriate treatment are expected to have negative culture results within 60 days of treatment. Extending treatment may be necessary if patients do not have a documented negative culture conversion. Having negative results automatically reported to the Department will decrease the time it takes for patients to be deemed non-infectious and will assist the Department in determining the optimal treatment length for TB patients.

 

H)    Amend Health code §13.03(b)(3) to require reporting of negative hepatitis C virus (HCV) nucleic acid tests (NAT) (electronic laboratory reporting only).  The Department is proposing that the Board amend Health Code §13.03(b)(3) to require reporting of all HCV NAT results. This provision currently specifies only that HCV (and other hepatitis) reports made by clinical laboratories be accompanied by results of alanine aminotransferase testing (ALT).  The addition of required reporting of NAT results will support the Department’s 2013 plan[3] to reduce illness and death from HCV. One component of this plan involves strengthening the Department’s capacity to manage and utilize data for evidence-based policies and practice. By receiving reports of both positive and negative test results for HCV NAT, the Department will be able to estimate the number of persons tested, the burden of chronic HCV infection in New York City, the number of persons treated for and cured of chronic HCV infection, and monitor changes over time, similar to what is currently authorized for human immunodeficiency virus (HIV) infection.

 

As many as 146,500 New York City residents may have chronic HCV. The disease is most prevalent in New York City neighborhoods with high poverty. Most persons living with HCV have few symptoms of illness until 10 to 30 years after initial infection, when life-threatening health complications, including cirrhosis and liver cancer, can develop. The annual number of deaths associated with HCV has been increasing yearly and, since 2007, has exceeded deaths associated with HIV in the United States. Highly effective HCV antiviral treatments have recently been approved, and more are expected in the coming years, making it likely that liver failure, cancer, and death from HCV can be averted in the future.

 

Antibody screening tests for HCV are recommended for all persons born between 1945 and 1965 and for patients with risk factors, including any history of injection drug use or receipt of a blood transfusion before 1992. However, 15-25% of patients who test HCV antibody positive have no detectable HCV nucleic acid in their blood, indicating that they do not have HCV infection. This is usually because they either resolved a prior HCV infection or had a false-positive HCV antibody test. Therefore, it is recommended that all patients with a positive HCV antibody test undergo HCV NAT testing to determine infection status.

 

The Department found that, from 2009 to 2012, 27% of patients with a positive HCV antibody never received an HCV NAT test, while an additional 9% only received NAT testing after the Department sent a reminder to the clinician that NAT testing is recommended.

 

Currently, both the Sanitary Code and Health Code § 11.03 mandate reporting by health care providers and others of persons who are cases and carriers of HCV. Laboratories must report positive HCV antibody screening tests and all positive confirmatory assays, e.g., recombinant immunoblot assay (RIBA) or NAT, that result from laboratory analysis of specimens in accordance with the “Laboratory Reporting of Communicable Diseases, 2010” guidance issued by the Department and the New York State Department of Health.  With nearly 10,000 new cases of HCV reported each year, the Department does not currently have sufficient staff resources to conduct individual case investigations by chart review and patient and provider interviews to determine infection and treatment status.  If the Department received results of both positive and negative tests for HCV NAT, this would provide more useful information for tracking the HCV epidemic in New York City. First, it would be possible to accurately classify patients as chronically infected by determining which antibody-positive patients are infected (NAT positive) versus not infected (NAT negative). Second, it would be possible to evaluate HCV testing patterns and focus outreach efforts toward providers who are not following HCV NAT testing recommendations. Third, by making all HCV NAT results reportable, the Department would also be able to estimate the proportion of patients who are receiving care for their diagnosis. For example, patients with only an antibody test but no NAT test would presumably not be in care. Patients who are NAT positive, but become NAT negative over time, would be presumed to be on treatment and, if the negative NAT tests are sustained, to be cured. The Department would be able to use these data to target interventions to those neighborhoods that have persistently higher levels of HCV viral loads based on HCV NAT results. These data could also be used to identify and prioritize linkage to care for persons who have been diagnosed with chronic HCV but have been lost to medical follow-up. Finally, these data will help the Department evaluate and, as needed, enhance our policies and programs on HCV prevention and control.

 

Therefore, the Department is requesting the Board to include a requirement for laboratories to report negative HCV NAT test results through the Department’s electronic reporting mechanism set forth in Health Code § 13.03(c).

 

I)       Amend Health code §13.03(b)(3) to require reporting of negative hepatitis B virus (HBV) test results for children for children ages 168 days to 1,825 days (six months of age up to the fifth birthday).The addition of required reporting of HBsAg (hepatitis B surface antigen) and anti-HBs (hepatitis B surface antibody) test results for children ages six months to five years of age will support the Department’s efforts to help prevent perinatal HBV among children born to HBV-infected mothers and to conduct surveillance for this nationally notifiable disease. Children born to HBV-infected mothers are at high risk of acquiring this infection. If infected, 90% will develop chronic hepatitis infection, placing them at risk for cirrhosis and hepatic carcinoma at an early age.

 

Each year, the Department case manages approximately 1,800 babies born to HBV positive pregnant women in New York City. Through individual patient education and case management, the Department helps to ensure that the newborns receive HBV immune globulin and HBV vaccine within 12 hours of birth and two more doses of HBV vaccine by six months of age to prevent HBV infection. These high-risk children should have post-vaccination serology testing performed at nine months of age to assess if they are infected, susceptible, or immune. Interpretation requires the test results for both HBsAg and anti-HBs. Children who are found to be infected have to be referred to a specialist for evaluation and treatment.  Children who are found susceptible after the first immunization series have to immediately begin a second three dose series of HBV vaccination.

 

Currently, the Department contacts the pediatric provider who administered the HBV vaccinations to provide reminders and to obtain post-vaccination serology testing results. This activity consumes approximately 25% of staff time. In addition, the Department is frequently unable to obtain all test results due to not being able to locate the family or the pediatric provider. The Department does not obtain test results for approximately 40% of the 1,800 babies managed annually. By requiring reporting of all test results for HBsAg and anti-HBs for children ages six months to five years, the Department will receive post-vaccination serology test results more efficiently and completely. The Department will be better able to manage cases lost to follow-up either by the Department or by other health jurisdictions, which may have cases that have moved to New York City.




[1]Mac Kenzie WR, Hoxie NJ, Proctor ME, Gradus MS, Blair KA, Peterson DE, et al. A massive outbreak in Milwaukee of cryptosporidium infection transmitted through the public water supply. NEJM 1994; 331(3): 161-167.

 

[2]Marx MA, Rodriguez CV, Greenko J, et al. Diarrheal illness detected through syndromic surveillance after a massive power outage: New York City, August 2003. Am J Public Health. 2006;96(3):547-53.

[3] Hepatitis C in New York City: State of the Epidemic and Action Plan.  Available at http://www.nyc.gov/html/doh/downloads/pdf/cd/hepC-action-plan.pdf

 

Subject: 

Proposed resolution regarding reportable diseases and conditions, and laboratories (Articles 11 and 13 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 11101-4132
Contact: 

Svetlana Burdeynik at (347) 396-6078 or resolutioncomments@health.nyc.gov
New York City Department of Health and Mental Hygiene
Gotham Center, 42-09 28th Street, CN 31
Long Island City, NY 11101-4132

Download Copy of Proposed Rule (.pdf):