Proposal to Amend Health Code Articles 11 & 13 Marci Layton, MD New York City Department of Health and Mental Hygiene

Articles 11 & 13 Article 11 regulates surveillance and control activities for the diseases, conditions, and events that providers and labs must report to the Department Article 13 regulates the manner in which lab tests must be performed and reported to the Department

Amendments to Articles 11 & 13 The requirements for reportable diseases, conditions, and events periodically need updating as: New diseases emerge Monitoring is no longer necessary for others NYS Public Health Law is updated Testing technologies evolve

7 Proposed Amendments to Articles 11 & 13 1 will reduce unnecessary reporting burden on providers and labs 2, 3 and 4 will update requirements for reporting and case isolation 5 and 6 will augment testing and reporting by providers and labs 7 will maintain critical lab testing capacity in NYC -Note: not presented in the order of the Health Code itself or the NOI

Amend Diseases Reportable by Providers & Labs 1. Remove Hepatitis D and E and “other suspected viral hepatitides” from list Hepatitis D is uncommon in the U.S. and can only exist in the presence of hepatitis B Hepatitis E is uncommon in the U.S., usually linked to foreign travel, and has no treatment Other infectious hepatitis strains are extremely rare -Hepatitis D and E were added to the list of reportable disease in 2005 largely due to outbreaks observed abroad; after 10 years of surveillance, the Department has determined that monitoring is no longer necessary -Only 21 reported cases of Hepatitis D in NYC from 2013 to 2015; hepatitis B surveillance, immunization, and treatment the bests means of preventing hepatitis D -Of 86 reported cases of Hepatitis E in NYC from 2006-2009, 67% were falsely diagnosed and 89 percent of confirmed cases had a history of foreign travel; no specific vaccine or antiviral therapy and most infected individuals recover completely; Department stopped routine case investigations in 2010 -Infectious hepatitis strains that pose a risk to public health would be reportable pursuant to required reporting of outbreaks, unusual manifestations of disease, and newly apparent or emerging diseases of uncertain etiology that could possibly be communicable

7 Proposed Amendments to Articles 11 & 13 1 will reduce unnecessary reporting burden on providers and labs 2, 3 and 4 will update requirements for reporting and case isolation 5 and 6 will augment testing and reporting by providers and labs 7 will maintain critical lab testing capacity in NYC -Note: not presented in the order of the Health Code itself or the NOI

Clarify Requirements for Disease Reporting 2. Add Zika virus to the list of named acute arboviral infections Suspected and confirmed cases of acute arboviral infections are reportable Currently, 13 viruses are named including chikungunya and dengue Addition of Zika is for clarity No change in reporting obligations for providers and labs

Update Requirements for Immunization Reporting 3. Allow non-written consent for reporting of adult immunizations Written consent is a barrier to reporting New York State Public Health Law was amended in 2013 to allow non-written consent for immunization reporting to State and City registries

Clarify Requirements for Isolation of Cases 4. Add varicella to list of diseases for which isolation of cases is required in hospitals and other clinical facilities Currently, 16 diseases are named, including measles, mumps, smallpox, TB Varicella can be spread through the air In June 2016, a one-year-old baby developed varicella after being exposed to infected patients at a medical facility -Health Code §11.17(a) requires isolation of patients in a healthcare facility suspected or confirmed with diphtheria, rubella (German measles), influenza with pandemic potential, invasive meningococcal disease, measles, monkeypox, mumps, pertussis, poliomyelitis, pneumonic form of plague, severe or novel coronavirus, vancomycin intermediate or resistant Staphylococcus aureus (VISA/VRSA), smallpox, tuberculosis (active), vaccinia disease, viral hemorrhagic fever or any other contagious disease that in the opinion of the Commissioner may pose an imminent and significant threat to the public health.

7 Proposed Amendments to Articles 11 & 13 1 will reduce unnecessary reporting burden on providers and labs 2, 3 and 4 will update requirements for reporting and case isolation 5 and 6 will augment testing and reporting by providers and labs 7 will maintain critical lab testing capacity in NYC -Note: not presented in the order of the Health Code itself or the NOI

Augment Reporting for TB in Children under 5 Years Providers are currently required to report positive tests for TB infection for this age group Young children have increased risk of developing active TB and life-threatening forms of TB From 2014-2015, 205 children < 5 years were reported with latent TB infection -From 2014-2015, 205 children <5 years of age were reported with latent TB infection

Augment Reporting for TB in Children under 5 Years 5a. Require providers to submit positive radiology reports and report initiation of treatment for TB infection 5b. Require labs to report blood-based or other tests positive for TB infection Will improve surveillance for high-risk group and reduce burden of seeking radiology reports Will ensure providers rule out active disease and start children on treatment

Augment Lab Reporting for Syphilis Syphilis tests can be indeterminate Reporting of these not mandated If reported, indeterminate = positive Ensures that no case is missed Case and field investigation activities initiated for many patients Providers, patients, partners contacted In 2015, 1968 indeterminate results were reported in NYC  558 cases (33%) -Many different scenarios (which are difficult to quantify in our surveillance system) can account for the other 67%, including: -Not a case, based on additional negative test results -Case counted in another jurisdiction -Unknown, since case was not investigated -There are not sufficient resources to investigate all indeterminate cases. Cases are prioritized for investigation based on epidemiology (e.g. age, gender). Where cases cannot be investigated, we rely on the provider to assist with case determination. -A combination of mandated lab-based follow up testing of indeterminate specimens and reporting of follow-up results can help improve the specificity (and thus effectiveness) of disease intervention activities

Augment Lab Reporting for Syphilis 6. Require labs to report indeterminate syphilis results and perform a second test on the same specimen, then report the results of that test (if also indeterminate, additional testing is not required) Will enable prompt treatment and reduce risk of disease progression and transmission Will allow for the focus of resources on patients with confirmed infections and those exposed -For treponemal tests, a different treponemal test must be performed; for non-treponemal tests, the same or a different non-treponemal test must be performed.

7 Proposed Amendments to Articles 11 & 13 1 will reduce unnecessary reporting burden on providers and labs 2, 3 and 4 will update requirements for reporting and case isolation 5 and 6 will augment testing and reporting by providers and labs 7 will maintain critical lab testing capacity in NYC -Note: not presented in the order of the Health Code itself or the NOI

Cultures vs. Culture-Independent Diagnostic Tests Labs are increasingly using culture-independent diagnostic tests (CIDTs) to test for enteric pathogens, instead of performing culture testing At least 2 labs in NYC no longer have the capacity to perform culture testing Unlike CIDTs, culture testing produces samples of the pathogen (“isolates”)

Cultures vs. Culture-Independent Diagnostic Tests Isolates are necessary for cluster and outbreak detection, and especially for controlling enteric diseases Continued use of culture testing of enteric specimens is strongly encouraged by: Association of Public Health Laboratories Centers for Disease Control and Prevention -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. -The Association of Public Health Laborites has urged public health authorities to review and revise current testing requirements to ensure continued use of culture testing methods -An MMWR encourages laboratories to culture enteric specimens with a positive CIDT result. (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)

Require Labs to do Culture Testing for Enteric Diseases 7. Require labs to perform culture testing when a CIDT test is positive for Campylobacter, Listeria monocytogenes, Salmonella, Shigella, Vibrio, or Yersinia and submit that isolate; for Shiga toxin-producing Escherichia coli (STEC), the lab must submit an isolate or a Shiga toxin-positive broth and stool Will ensure labs in NYC maintain the capacity to conduct these important tests

Require Labs to do Culture Testing for Enteric Diseases At least 2 states (CT, CA) now mandate reflex to culture testing and isolate submission for select enteric diseases No negative feedback or payment issues reported -California for Listeria, Salmonella, Shigella, and STEC, and Connecticut for Salmonella, Shigella, and Vibrio. Many states require laboratories to submit either the specimen or isolates to a public health laboratory for further testing; some states require isolates to be submitted if available.