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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): 

Adopted Rules: Closed to Comments

Adopted Rules Content: 

 DEPARTMENT OF HEALTH AND MENTAL HYGIENE

Statement of Basis and Purpose

       The Charter provides the Department with jurisdiction over all matters concerning health in the City of New York. The Bureau of Child Care, in the Department’s Division of Environmental Health, enforces Article 47 (Day Care Services) and Article 43 (School-Based Programs for Children Ages Three Through Five) of the Health Code. Article 47 regulates all public and private group day care services for children less than six years of age. Article 43 contains health and safety standards for school-based programs for children ages three through five.  

       The Board is amending Articles 47 and 43 to require that children attending child care services and school-based programs under the Department’s jurisdiction receive annual vaccinations against influenza, and to add immunization against pneumococcal disease to the list of required pre-admission immunizations in these Articles.  Full citations for reports and studies cited in the section on influenza vaccination are listed at the end of this Statement of Basis and Purpose.

 Influenza vaccination

       Influenza causes an estimated 200,000 hospitalizations and an average of 36,000 (range 3,000-49,000) deaths annually in the United States (CDC, 2010). Approximately 20,000 hospitalizations and 30-150 deaths occur in children under 5 years of age each year.  Children typically have the highest attack rates of influenza, which can be as high as 40%, and children serve as a major source of transmission within communities.  Each year, an estimated 15%-42% of preschool children contract influenza, and 38 million school days are missed due to influenza illness (CDC/ National Center for Health Statistics, 1999).

        Influenza strains vary from year to year. The US Food and Drug Administration annually licenses influenza vaccines for administration based on a scientific consensus identifying “virus strains  likely to cause the most illness during the upcoming flu season” (generally October through April in the middle Atlantic states). (USFDA, 2012) Vaccination only protects against the strains specifically included in the approved vaccine. Therefore, immunization is only effective for the year in which it is given, and a different influenza vaccine generally needs to be administered each year. The effectiveness of influenza vaccine varies with the severity of flu season, circulating influenza viruses, vaccine composition, and the age group studied. In children less than 6 years of age, influenza vaccine efficacy, ability to prevent influenza infection, ranged from 59%-82%; effectiveness, a measure of how vaccine performed in real world settings in preventing influenza, ranged from 24%-36%.(T Jefferson, 2005; M Fujieda, 2006; Jefferson, 2008; Hoberman, 2003; Longini I, 2012) Belshe et. al. showed that live attenuated influenza vaccine (LAIV) was 55% more effective than trivalent inactivated vaccine (TIV) in preventing laboratory-confirmed influenza in children 6-59 months old (Belshe, 2007).

        Influenza vaccination has been found to be safe for use in children (Hambridge SJ, 2006; Glanz JM, 2011; France EK, 2004; Bernstein DI, 1982, Skowronski DM 2006). Based on the scientific evidence, the federal Advisory Committee on Immunization Practices – which sets the standard of care for the United States – recommends that everyone 6 months of age and older receive an annual influenza vaccination. Trivalent inactivated vaccine (TIV) is licensed for use in all children >6 months of age, and live attenuated influenza vaccine (LAIV; delivered as a nasal spray) is licensed for use in children >24 months. 

         Vaccinating children produces “herd immunity” in the general population. This means that. vaccinating children against influenza reduces the number of influenza infections in everyone else, regardless of whether they were vaccinated or not (Piedra PA, 2005). Vaccinating younger children may also protect against secondary cases (Reichert, 2001). One study looked at respiratory illness in household contacts of vaccinated and unvaccinated children attending daycare. Among study participants, vaccine efficacy  in preventing  proven influenza infection by measuring protective levels of antibodies was 45% for influenza B and 31% for influenza A (H3N2) during the 1996-97 influenza season.  The greatest effect of vaccination was seen in household contacts 5 to 17 years of age; household contacts of vaccinated children  had a 50% reduction in respiratory illnesses and an 80% reduction in febrile respiratory illness compared to unvaccinated children.  Statistically significant declines in illness were not seen for household contacts of younger children or adults, though the study was limited by small sample size (ES Hurwitz, 2000).  A second paper found a correlation between states with higher influenza immunization coverage among 19-35 month-olds and reduced influenza and pneumonia hospitalizations rates among adults over the age of 65 (based on claims records for Medicare eligible P&I hospitalizations) (SA Cohen, 2011).  This analysis was conducted before routine pediatric influenza vaccination; summary coverage estimates rose from 8.3% in 2002-2003 to 33.5% in 2005-2006.

         Despite active promotion of influenza vaccination for children, coverage rates have risen slowly in New York City. As of March 26, 2013, 61.0% of children ages 6 months through 59 months received at least one dose of influenza vaccine compared to 56.7% at the same time in 2012.  This still leaves nearly 4 out of every 10 young children unprotected. Furthermore, young children are at high risk of influenza-related complications and hospitalization, making this vulnerable group especially important to protect.[1]

        Finally, while child day care permittees and persons in charge of schools are required by Health Code §§47.27(e) and 43.19(e) to report to the Department within 24 hours any instance of a vaccine preventable disease, the Department does not expect individual cases of seasonal influenza to be reported. Reports by schools and day care facilities will, however, continue to be required as provided in Health Code §11.03 (a) and (b) of cases of a novel strain of influenza with pandemic potential, the influenza related death of a child under 18 years of age, or an outbreak of influenza.

 Pneumococcal disease immunization

        The Board is also amending Health Code §§43.17(a)(2) and 47.25(a)(2) to add “pneumococcal disease” to the list of required immunizations. This immunization, which is required by Public Health Law §2164(2), was inadvertently omitted from these sections. 

 References:

Belshe, R, Edwards K, Vesikari T, et. al. Live attenuated versus inactivated influenza vaccine in infants and young children. NEJM. 2007;356(7):685-696.

Bernstein DI, Zahradnik JM, DeAngelis CJ, et. al. Clinical reactions and serologic responses after vaccination with whole-virus or split-virus influenza vaccines in children aged 6 to 36 months. Pediatrics. 1982;69:404-408.

CDC. Estimates of Deaths Associated with Seasonal Influenza - United States, 1976-2007. MMWR. 2010;59(33):1057-1062.

CDC/ National Center for Health Statistics. Current estimates from the National Health Interview Survey, 1999.  Series 10, No 200.

Cohen G, Nettleman M. Economic impact of vaccination in preschool children. Pediatrics. 2000;106(5):972-976.

France EK, Glanz JM, Xu S, et. al. Safety of the trivalent inactivated influenza vaccine among children: a population-based study. Arch Pediatr Adolesc Med. 2004;158(11):1031-1036.

Fujieda M, Maeda A, Kondo K, et. al. Inactivated influenza vaccine effectveness in children under 6 years of age during the 2002-2003 season. Vaccine. 2006;27(7):957-963.

Glanz JM, Newcomer SR, Hambidge SJ, et. al. Safety of trivalent inactivated vaccine in children aged 24 to 59 months in vaccine safety datalink. Arch Pediatr Adolesc Med. 2011;165(8):749-755.

Hambidge SJ, Glanz JM, France EK, et. al. Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old. JAMA. 2006;296(16):1990-1997.

Hoberman A, Greenberg D, Paradise J, et. al.  Effectiveness of inactivated influenza vaccine in preventing acute otitis media in young children. 2003;290(12):1608-1616.

Hurwitz E, Haber M, Chang A, et. al. Effectiveness of influenza vaccination of day care children in reducing influenza-related morbidity among household contacts. JAMA. 2000;284(13):1677-1682.

Jefferson T, Rivetti A, Harnden A, et. al. Vaccines for preventing influenza in healthy children. Cochrane Database Syst Rev. 2008;(2):CD004879.

Jefferson T, Smith S, Harnden A, et. al. Assessment of the fficacy and effectiveness of influenza vaccines in healthy children: systematic review. Lancet. 2005;365:773-780.

Longini I. A theoretic framework to consider the effect of immunizing schoolchildren against influenza: implications for research. Pediatrics. 2012;129(S2):S62-S67.

Piedra PA, Manjusha GJ, Kozinetz CA, et. al. Herd immunity in adults against influenza-related illnesses with use of the trivalent-live attenuated influenza vaccine (CAIV-T) in children. Vaccine. 2005;23(13):1540-1548.

Reichert TA, Sugaya N, Fedson DS, et. al. The Japanese experience with vaccinating schoolchildren against influenza. NEJM. 2001;344(12):889-896.

Skowronski DM, Jacobsen K, Daigneault J, et. al. Solicited adverse events after influenza immunization among infants, toddlers, toddlers, and their contacts. Pediatrics. 2006;117(6):1963-1971.

US Food and Drug Administration. News Release, FDA approves vaccines for the 2012-2013 influenza season.  www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm315365.htm


 

[1] Seasonal influenza vaccinations are currently required for children aged 6 months through 59 months attending any child care or preschool facility in New Jersey and Connecticut. Since 2008, the New Jersey Department of Health and Senior Services has required administration of at least one dose of influenza vaccine to these children between September 1 and December 31 each year (New Jersey Administrative Code §8:57-4.19). Since 2010, the Connecticut Department of Public Health pursuant to its commissioner’s authority to establish vaccination schedules (see, Connecticut General Statutes §19a-7f) has required children aged 6 months through 59 months attending day care to receive at least one dose of influenza vaccine between September 1 and December 31 each year. Connecticut preschoolers (aged 24-59 months) are required to have one dose between August 1 and December 31 each year. Connecticut day care and preschool enrollees receiving influenza vaccine for the first time are required to have two doses of vaccine, administered at least 28 days apart. Connecticut children attending kindergarten classes are not required to have influenza vaccinations.

Effective Date: 
Tue, 01/21/2014