Proposal to Amend Health Code Articles 11 & 13

1. Proposal to Amend Health Code Articles 11 & 13 Marci Layton, MDNew York City Department of Health and Mental Hygiene

2. 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

3. 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

4. 7 Proposed Amendments to Articles 11 & 13 • 1 will reduce unnecessary reporting burden on providers and labs • 2, 3 and4 will update requirements for reporting and case isolation • 5and 6 will augment testing and reporting by providers and labs • 7 will maintain critical lab testing capacity in NYC

5. 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

6. 7 Proposed Amendments to Articles 11 & 13 • 1 will reduce unnecessary reporting burden on providers and labs • 2, 3 and4 will update requirements for reporting and case isolation • 5and 6 will augment testing and reporting by providers and labs • 7 will maintain critical lab testing capacity in NYC

7. 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 Zikais for clarity • No change in reporting obligations for providers and labs

8. 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

9. 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

10. 7 Proposed Amendments to Articles 11 & 13 • 1 will reduce unnecessary reporting burden on providers and labs • 2, 3 and4 will update requirements for reporting and case isolation • 5and 6 will augment testing and reporting by providers and labs • 7 will maintain critical lab testing capacity in NYC

11. 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

12. 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

13. 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%)

14. 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 notrequired) • 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

15. 7 Proposed Amendments to Articles 11 & 13 • 1 will reduce unnecessary reporting burden on providers and labs • 2, 3 and4 will update requirements for reporting and case isolation • 5and 6 will augment testing and reporting by providers and labs • 7 will maintain critical lab testing capacity in NYC

16. 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”)

17. 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

18. 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

19. 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