Requirement for Influenza Vaccination of Health Care Personnel: New York State’s Experience

1. Requirement for Influenza Vaccination of Health Care Personnel: New York State’s Experience Debra Blog, MD, MPH Bureau of Immunization New York State Department of Health January 20, 2010

2. Pre-existing Immunization Requirements for Certain Health Care Facilities (Not LTCFs) • In regulation • Must have immunity to measles and rubella • Must have annual PPD test for TB • Some individual facilities require more, eg. mumps and varicella, but not in regulation • Requirement for measles, rubella, and PPD: NO religious exemption.

3. Long Term Care Facilities • April 2000, Article 21A, the Long term Care Resident and Employee Immunization Act required that influenza immunization be offered to all residents and employees (and pneumococcal vaccine as appropriate) • Includes nursing homes, adult day health care programs, adult homes, and enriched housing programs • Employee can refuse • Vaccination status must be documented yearly

4. LTCFs Continued • The enactment of this law has failed to promote consistent immunization rates of personnel over 44%

5. Influenza/Immunization Requirements • For LTCFs in statute • For certain health care facilities in regulation

6. Efforts Made Under a Voluntary System • Two letters from the NYSDOH Commissioner emphasizing influenza immunization of health care personnel as the standard of care • Emphasized in many advisories • Tool kits • Continuous promotion of influenza vaccination and the use of incentives • Educational materials • Outreach to healthcare partners • Media campaigns

7. Laying the Foundation for Regulatory Change • Preparation for this change was implemented over past few years. Included: • Meetings with partners • Outreach to nurses’ unions/organizations • Educational efforts • Presentations to the State Hospital Review and Planning Committee (SHRPC) meetings, which are open to the public

8. Timeline • SHRPC voted to accept as an emergency regulation on August 13, 2009, effective immediately. • Included both seasonal and H1N1 influenza vaccines • Emergency reg was renewed once • Regulation suspended on October 23, 2009 due to lack of sufficient supply of both types of vaccine (along with other NYS flu laws)

9. Subpart 66-3 – Health Care Facility Personnel Influenza Immunization Requirements • Definitions • Health care facility-personnel influenza immunization requirements • Health care facility requirements, existing personnel • Health care facility requirements, new personnel • Documentation • Exceptions • Reporting requirements

10. Definitions • Medically contraindicated • Vaccination would be detrimental to the person’s health • In a manner recognized nationally • Guidance will be posted on the NYSDOH website • Personnel-broad definition • All persons employed or affiliated • Paid or unpaid-includes members of the medical staff, contract staff, students, and volunteers • who either have direct contact with patients or whose activities are such that if they were infected with influenza, they could potentially expose patients, or others who have direct contact with patients

11. Definitions Continued • Health Care Facilities (HCFs) • General hospitals • Diagnostic and Treatment Centers • Certified Home Health Agencies • Licensed Home Care Service Agencies • Long Term Home Health Care Programs • AIDS Home Care Programs • Hospices

12. Personnel influenza immunization requirements • HCFs must notify personnel about the requirement • HCFs must require that all be immunized against influenza • Immunization will be conducted according to national recommendations in effect and posted on the NYSDOH website • Immunization will take place unless the Commissioner of Health has determined that supply is not adequate

13. Cost of Vaccination • HCFs must offer influenza at no cost to the personnel • Personnel can obtain the vaccination elsewhere but then the person or their insurance will have to pay for it

14. Existing Personnel • If personnel choose to get vaccinated elsewhere documentation must be provided • Vaccination or provision of documentation no later than November 30 of each year

15. New Personnel • If enters employment after November 30th but before April 1 • Needs influenza immunization status evaluated • If not immunized for the current season, need to do so • Can receive elsewhere if provides documentation

16. Documentation • HCF must document annual influenza vaccination in the personnel files • Must record • date, site of administration, type of vaccine, dose, manufacturer, lot number, that a vaccine information statement was given to the vaccinee and which one, name of the person giving the vaccination, any reactions known • If vaccinated elsewhere HCF must document date, type of vaccine, dose, and name of person administering the vaccine

17. Exceptions • Medical contraindications only • Immunization will be conducted according to national recommendations in effect and posted on the NYSDOH website • Consistent with previous regs

18. Reporting requirements • Each HCF shall collect and report aggregate data on influenza immunization of personnel • Shall report on the status of personnel between April 1 and March 31 of each year • Report to the NYSDOH by May 1 of each year • Data to include but not be limited to: number of personnel immunized by occupation, total number of personnel by occupation, reasons any personnel did not receive vaccine

19. Response • Strong opposition from nurses • New York State Nurses Association (NSYNA) was opposed • Thousands of letters • Thousands of phone calls • Several small protests • Organized letter writing campaigns • Anti-vaccine movement became involved • Two law suits

20. NYSDOH Experience • Rapidly changing Q and As drafted • Responding to the huge volume of calls and letters took up staff time • Staff was verbally attacked on the phone • All this right when H1N1 hit • A call center was set up to accept the thousands of phone calls • And then it all stopped

21. Some Sticking Points • Definition of personnel was difficult to interpret and operationalize • Lack of religious exemption was contentious • Adhering to a standard of medical exemptions was also contentious • What should be done with those who refused • What should be done with those who have medical exemptions

22. Future • Regs are being revised and clarified based on what we learned • Plans are to go forward with permanent adoption • Plans to address long term care facilities through statute