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Adopted Rules: Closed to Comments

Adopted Rules Content: 

Statement of Basis and Purpose of Final Rule

 

The Fire Department has amended 3 RCNY §102-01, entitled “Pre-Existing Facilities and Conditions,” to address pre-existing conditions and facilities arising from enactment of an amended New York City Fire Code by Local Law No. 148 of 2013, and projects in progress as of March 30, 2014, the effective date of the amended Fire Code.

 

Section 102-01 expanded upon the Fire Code provision (FC102.3) that addresses facilities and conditions lawfully existing on July 1, 2008, the effective date of the Fire Code.   Section FC102.3 allowed facilities and conditions lawfully existing as of that effective date to be continued under the laws, rules and regulations under which those facilities and conditions were allowed or approved, subject to certain conditions.

 

The final rule amended and updated Section 102-01 to address facilities designed and installed under the Fire Code that took effect on July 1, 2008 (or other lawful conditions arising after that date) that were no longer allowed under the amended Fire Code that took effect on March 30, 2014.  The section was also amended to clarify the purpose and meaning of the section and provide additional illustrative examples.  For example, dead end fire apparatus turnarounds and paint spray booths that were approved and constructed under pre-existing Fire Code and Fire Department rule provisions may be maintained in accordance with those provisions even though the Fire Code or rule requirements for such facilities have changed.

 

Section 102-01 also made provision for buildings designed and approved for construction prior to July 1, 2008, the effective date of the Fire Code, but not completed.  It allowed, for a specified period of time, such “projects in progress” to be constructed in accordance with the Fire Code design and installation requirements in effect at the time the Department of Buildings work permit was issued, subject to certain conditions.

 

The final rule amended and updated Section 102-01 to address buildings designed and approved for construction prior to March 30, 2014, the effective date of the amended Fire Code, but not completed.  It allows, for 18 months, such “projects in progress” to be constructed in accordance with the Fire Code design and installation requirements in effect at the time the Department of Buildings work permit was issued, subject to certain conditions.

 

The Fire Department’s authority for this rule is found in Sections 489 and 1043 of the New York City Charter and Section FC102.6.3 of the New York City Fire Code, Title 29 of the New York City Administrative Code.

 

Terms used in the rule that are defined in the Fire Code or elsewhere in the Fire Department’s rules are indicated by italics.

 

New material is underlined.  Deleted material is in [brackets].

 

“Shall” and “must” denote mandatory requirements and may be used interchangeably in the rules of this department, unless otherwise specified or unless the context clearly indicates otherwise.

 

Guidance with respect to the interpretation of the Fire Code and Fire Department rules may be obtained using the Public Inquiry Form on the Fire Department’s website, www.nyc.gov/html/fdny/html/firecode/index.shtml#p6.

 

Effective Date: 
Fri, 11/21/2014

Proposed Rules: Closed to Comments

Agency:
Comment By: 
Monday, September 15, 2014
Proposed Rules Content: 

Statement of Basis and Purpose of Proposed Rule Amendments

 

The Fire Department is proposing to amend rule 3 RCNY §102-01, entitled “Pre-Existing Facilities and Conditions,” to address pre-existing conditions and facilities arising from enactment of an amended New York City Fire Code by Local Law No. 148 of 2013, and projects in progress as of March 30, 2014, the effective date of the amended Fire Code.

 

Section 102-01 currently expands upon the Fire Code provision (FC102.3) that addresses facilities and conditions lawfully existing on July 1, 2008, the effective date of the Fire Code.   Section FC102.3 allows facilities and conditions lawfully existing as of that effective date to be continued under the laws, rules and regulations under which those facilities and conditions were allowed or approved, subject to certain conditions.

 

The proposed rule would amend and update Section 102-01 to address facilities designed and installed under the Fire Code that took effect on July 1, 2008 (or other lawful conditions arising after that date) that would no longer be allowed under the amended Fire Code that took effect on March 30, 2014.  The section would also be amended to clarify the purpose and meaning of the section and provide additional illustrative examples.  For example, dead end fire apparatus turnarounds and paint spray booths that were approved and constructed under pre-existing Fire Code and Fire Department rule provisions may be maintained in accordance with those provisions even though the Fire Code or rule requirements for such facilities have changed.

 

Section 102-01 also makes provision for buildings designed and approved for construction prior to July 1, 2008, the effective date of the Fire Code, but not completed.  It allowed, for a specified period of time, such “projects in progress” to be constructed in accordance with the Fire Code design and installation requirements in effect at the time the Department of Buildings work permit was issued, subject to certain conditions.

 

The proposed rule would amend and update Section 102-01 to address buildings designed and approved for construction prior to March 30, 2014, the effective date of the amended Fire Code, but not completed.  It would allow, for 18 months, such “projects in progress” to be constructed in accordance with the Fire Code design and installation requirements in effect at the time the Department of Buildings work permit was issued, subject to certain conditions.

 

The Fire Department’s authority for this rule is found in Sections 489 and 1043 of the New York City Charter and Section FC102.6.3 of the New York City Fire Code, Title 29 of the New York City Administrative Code.

 

Terms used in the proposed rule that are defined in the Fire Code or elsewhere in the Fire Department’s rules are indicated by italics.

 

New material is underlined.  Material to be deleted is in [brackets].

 

“Shall” and “must” denote mandatory requirements and may be used interchangeably in the rules of this department, unless otherwise specified or unless the context clearly indicates otherwise.

 

Guidance with respect to the interpretation of the Fire Code and Fire Department rules may be obtained using the Public Inquiry Form on the Fire Department’s website, www.nyc.gov/html/fdny/html/firecode/index.shtml#p6.

Subject: 

Pre-Existing Facilities and Conditions

Location: 
Fire Department Auditorium
9 MetroTech Center
Brooklyn, NY 11201
Contact: 

No contact

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):