1. Assessing State Immunization Requirements for Healthcare Workers and Patients Megan Lindley 1, Abigail Shefer 1, Gail Horlick 1, Margaret Clemens 2, Fred Shaw 2, Ray Strikas 1 1 National Immunization Program, CDC 2 Public Health Law Program, CDC March 6, 2006 The findings and conclusions in this presentation have not been formally disseminated by CDC and should not be construed to represent any agency determination or policy. This research was supported in part by an appointment to the Research Participation Program at the Centers for Disease Control and Prevention administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and CDC.

2. Background Laws requiring immunizations for elementary and middle school entry shown to improve vaccination coverage, and to reduce the incidence of vaccine-preventable diseases. Little is known about the use of immunization laws in other settings.

3. Purpose To conduct a detailed review of laws, regulations, and other legal requirements relating to immunization for employees and patients in healthcare settings, and selected other settings in which healthcare is provided To provide researchers and policymakers with descriptive information on immunization-related state laws

4. Settings & Target Groups Employees –Hospitals* –Ambulatory Care Facilities Patients/Residents –Hospitals* –Ambulatory Care Facilities –Individual Providers –Correctional Institutions –Developmentally Disabled Facilities *Specified vaccines: hepatitis B, MMR, varicella, influenza, and pneumococcal for employees; influenza & pnuemococcal for inpatients

5. Study Questions Assessment: Is the facility required to assess immunization status or screen for any vaccine-preventable disease (VPD)? Administration: –Offer: Is the facility required to offer or make available any vaccine to any employee/resident? –Ensure: Is the facility required to provide, arrange for or make certain that any employee/resident has been vaccinated against any VPD? Exemptions: medical, religious, philosophical

6. Areas of Law Analyzed (partial) Included*: Birthing centers Abortion facilities Group homes Child caring institutions Renal dialysis facilities Excluded: Post-exposure requirements TB screening Long-term care facilities Federal and municipal law *When the legal definition of the facility was included in the definition of a hospital, provider, ambulatory care facility, correctional institution or facility for the developmentally disabled that was developed by CDC’s PHLP for this review.

7. Methods Legal analysts in CDC’s Public Health Law Program collected statutes and regulations from all 50 states and D.C. –Lexis-Nexis –Public web-based databases Data collected September 2004 – June 2005 Legal counsel from each state given opportunity to comment on accuracy, completeness and interpretation of findings

8. Results: Assessment Laws by Setting

9. Results: Administration Laws by Setting

10. Results: Hospitals AssessAdministerEnsure (n) EMPLOYEES Hepatitis B2 (4%)17 (33%)1 Influenza04 (8%)2 MMR011 (22%)10 Varicella02 (4%)2 Pneumococcal00-- INPATIENTS Influenza2 (4%)3 (6%)2 Pneumococcal2 (4%)3 (6%)2

11. Results: Ambulatory Care Facilities AssessAdministerEnsure (n) EMPLOYEES Any immunizations3 (6%)23 (45%) Influenza031 MMR055 Hepatitis B3202 INPATIENTS Any immunizations7 (14%)6 (12%) Hepatitis B410 Rubella310 Routinely rec.354

12. Results: Individual Providers’ Patients AssessAdministerEnsure (n) Any immunizations25 (49%)10 (20%) Rubella6*10 Hepatitis B21*7***7 Routinely rec.2** 2 *Among pregnant women **Among pediatric patients ***Among newborns/infants

13. Results: Correctional Facilities AssessAdministerEnsure (n) Any immunizations12 (24%)18 (35%) Hepatitis B10-- Routinely rec. (all inmates) 833 Routinely rec. (juvenile detention) 415*15 *In 11 states, the law does not refer specifically to juvenile detention facilities, but is written in such a way that it could be interpreted as applying to such facilities.

14. Results: Facilities for the Developmentally Disabled AssessAdministerEnsure (n) Any immunizations20 (39%)40 (78%) Hepatitis B432 Routinely rec. (all residents) 61514 Routinely rec. (youth/children) 1129*28 *In 25 states, the law does not refer specifically to facilities for the developmentally disabled, but is written in such a way that it could be interpreted as applying to such facilities.

15. Results: Exemptions n (%)* Any exemption33 (75%) Medical exemption30 (68%) Religious exemption20 (45%) Philosophical exemption6 (14%) *Proportion among states with “ensure” laws, n=44

16. Challenges Definitions of facilities vary by state –Standard definitions for “hospital”, “ambulatory care facility”, and “individual provider” developed for project Fewer than half of state counsel (n=24) reviewed –Most agreed with results, but some interpretations changed Law is constantly being revised –Results as of 9/2005 Broad or unclear statutory language can create difficulties in interpretation –Potential for overly broad or narrow interpretation of laws

17. Example “ Ind. Admin. Code tit. 470, r. 3-11-75 requires that the child caring institution, after attempting to determine the child’s immunization status, ensures that each child has received immunizations and boosters required by the State Board of Health. Also, all children must be immunized against routine childhood disease. “Child caring institutions” are defined in Ind. Admin. Code tit. 470, r. 3-15-5 as place engaged in (among other things) receiving and caring for dependent children, children in need of services, or delinquent children. –Interpretation: assessment and “ensure” laws apply to facilities for the developmentally disabled –Does not apply to juvenile detention centers (response from state counsel)

18. Summary Novel scope: first review of state-level laws for healthcare settings in all 50 states and District of Columbia Few states have laws concerning the immunization of employees in hospitals and ambulatory care facilities –Most laws for hepatitis B; mostly “offer” Laws vary widely by state in terms of immunizations, settings & groups covered –In general, strongest requirements are for institutionalized populations

19. Implications Additional research is needed –Impact of laws on coverage –Enforcement mechanisms Need to ensure that state health department staff are aware of existing laws Dissemination of model laws may reduce variation among states and increase use of immunization laws in these settings

20. Megan C. Lindley, MPH ORISE/CDC Research Fellow National Immunization Program 404-639-8717 MLindley@cdc.gov Questions?

21. BACKUP SLIDES

22. Definitions Hospital: an institution whose primary function is to provide inpatient services, diagnostic and therapeutic, for a variety of medical conditions, both surgical and non-surgical, on a 24 hour a day basis. Ambulatory Care Facility: a freestanding medical clinic or medical care facility that provides a variety of healthcare services in a centralized facility. These services may include preventative care, acute care, specialized services, laboratory services, surgery, outpatient care, etc., and are provided to persons who come to the facility to receive services and depart from the facility on the same day. Provider: a licensed health care professional

23. Example II Code Me. R. § 10-144-264(2), relating to “Designated Healthcare Facilities” provides that Designated Healthcare Facilities shall require of all employees proof of immunization or documented immunity against rubeola, mumps, rubella, varicella, and hepatitis B…“Designated Healthcare Facility” is defined in Code Me. R. § 10-144-264(1) as a licensed nursing facility, residential care facility, intermediate care facility for the mentally retarded, multi-level health care facility, hospital, or home health agency. –Ensures MMR, varicella and hepatitis B vaccination for all hospital employees.

24. Example III For New Jersey, see N.J. Admin. Code tit. 8, § 8:43A- 28.8, relating to “birth centers.” N.J. Admin. Code tit. 8, § 8:43A-28.8 requires birth centers to offer patients with negative rubella titers the rubella vaccine after delivery and prior to discharge. Requirements governing “birth centers” are located in the chapter of the New Jersey Administrative Code setting forth the standards for the licensing of ambulatory care centers, thus identifying “birth centers” as a type of ambulatory care center, under New Jersey’s definition of “ambulatory care center.” –Offer law for rubella vaccination in birthing centers (ambulatory care facility patients)