216-RICR-20-15-7. Immunization, Testing, and Health Screening for Health Care Workers (version Adoption, 08/04/2002 to 02/14/2007)

RULES AND REGULATIONS PERTAINING TO IMMUNIZATION, TESTING, AND HEALTH SCREENING FOR HEALTH CARE WORKERS (R23-17-HCW) STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS DEPARTMENT OF HEALTH JULY 2002 i INTRODUCTION These rules and regulations are promulgated under the authority of Chapters 23-17 and 23-17.7 of the General Laws of Rhode Island, as amended, and are established in accordance with the most current recommendations of the Centers for Disease Control and Prevention for the purpose of adopting prevailing standards pertaining to requirements for immunizations and testing for communicable diseases and pre-employment health screenings for health care workers involved in direct patient contact in health care facilities licensed in Rhode Island. Pursuant to the provisions of section 42-35-3(c) of the General Laws of Rhode Island, as amended, consideration was given to: (1) alternative approaches to the regulations; (2) duplication or overlap with other state regulations: and (3) significant economic impact placed on small business as defined in Chapter 42- 35 of the General Laws as a result of the amended regulations. No alternative approach, overlap or duplication nor any significant economic impact was identified; consequently the regulations are adopted in the best interest of the health, safety and welfare of the public. These regulations shall supercede all pre-employment health screening and immunization requirements contained in the Rules and Regulations for Licensing Home Nursing Care Providers and Home Care Providers (R23-17-HNC/HC/PRO); the Rules and Regulations for Licensing of Hospitals (R23-17-HOSP); the Rules and Regulations for Licensing of Nursing Facilities (R23-17- NF); the Rules and Regulations for Licensing Rehabilitation Hospital Centers (R23-17-REHAB); the Rules and Regulations for the Licensing of Freestanding Ambulatory Surgical Centers (R23-17- FASC); the Rules and Regulations for the Licensing of Organized Ambulatory Care Facilities (R23- 17-OAC); the Rules and Regulations for Licensing Outpatient Rehabilitation Centers (R23-17- ORC); and the Rules and Regulations for the Licensing of School-based Health Centers (R23-17- SBHC) promulgated under Chapter 23-17 of the Rhode Island General Laws, as amended, and the Rules and Regulations for the Licensing of Nursing Service Agencies (R23-17.7-NSA) promulgated under Chapter 23-17.7 of the Rhode Island General Laws, as amended, and filed with the Secretary of State. ii TABLE OF CONTENTS Page 1.0 Definitions 1 2.0 General Requirements 2 3.0 Minimum Standards for Immunization and Communicable Disease Testing for Health Care Workers 3 4.0 Documentation of Immunity (Immunization Records) 5 5.0 Exemptions 5 6.0 Severability 6 References 7 Appendix "A" 8 1 Section 1.0 Definitions Wherever used in these rules and regulations, the following terms shall be construed as follows: 1.1 "Certified registered nurse practitioner (RNP)" means a registered nurse who practices in an advanced role utilizing independent knowledge of physical assessment and management of health care and illnesses. The practice includes prescriptive privileges, and collaboration with other licensed health care professionals, including, but not limited to, physicians, pharmacists, podiatrists, dentists and nurses. 1.2 “Department” means the Rhode Island Department of Health. 1.3 "Direct patient contact", as used herein, means any face-to-face interaction with patients in a health care facility. 1.4 “Director” means the Director of the Rhode Island Department of Health. 1.5 "Health care facility" means any institutional health service provider, facility or institution, place, building, agency, or portion thereof, whether a partnership or corporation, whether public or private, whether organized for profit or not, used, operated, or engaged in providing health care services, including but not limited to hospitals; nursing facilities; home nursing care provider (which shall include skilled nursing services and may also include activities allowed as a home care provider, or as a nursing service agency); home care provider (which may include services such as personal care or homemaker services or as a nursing service agency); nursing service agency; rehabilitation centers; kidney disease treatment centers; health maintenance organizations; free-standing emergency care facilities, and facilities providing surgical treatment to patients not requiring hospitalization (surgi-centers); hospice care, physician office settings providing surgical treatment and nursing service agencies licensed under the provisions of Chapter 23-17.7 of the Rhode Island General Laws, as amended. The term "health care facility" also includes organized ambulatory care facilities which are not part of a hospital but which are organized and operated to provide health care services to outpatients such as central services facilities serving more than one health care facility or health care provider, treatment centers, diagnostic centers, rehabilitation centers, outpatient clinics, infirmaries and health centers, school-based health centers and neighborhood health centers; providing, however, that the term "health care facility" shall not apply to organized ambulatory care facilities owned and operated by professional service corporations as defined in chapter 5.1 of title 7, as amended (the "Professional Service Corporation Law"), or to a private practitioner's (physician, dentist, or other health care provider) office or group of the practitioners' offices (whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation, organization, or association). Individual categories of health care facilities shall be defined in rules and regulations promulgated by the licensing agency with the advice of the Health Services Council. Rules and regulations concerning hospice care shall be promulgated with regard to the "Standards of a Hospice Program of Care", promulgated by national hospice organization. Any provider of hospice care who provides such hospice care without charge shall be exempt from the licensing provisions of Chapter 23-17 of the Rhode Island General Laws, as amended, but shall meet the "Standards of a Hospice Program of Care." Facilities licensed by the Department of Mental Health, Retardation and Hospitals, and the 2 Department of Human Services, and clinical laboratories licensed in accordance with chapter 16.2 of Title 23, as well as Christian Science institutions (also known as Christian Science Nursing Facilities) listed and certified by the Commission for Accreditation of Christian Science Nursing Organizations/Facilities, Inc. shall not be considered health care facilities for purposes of Chapter 23-17 of the Rhode Island General Laws, as amended. 1.6 “Health care worker” means any person who has or may have direct contact with a patient in a health care facility. This may include, but not be limited to, a physician, dentist, nurse, optometrist, podiatrist, physical therapist, social worker, pharmacist, psychologist, student, on-site faculty, receptionist, dietary staff, housekeeping staff, security personnel, and any officer, employee or agent of that provider acting in the course and scope of his or her employment or agency related to or supportive of health services. For the purposes of these regulations, as they apply to hospitals, "health care worker" shall also mean those non-employee staff, such as volunteers, who are involved in direct patient contact. Transient employees not involved in direct patient contact or outside contractors not involved in direct patient contact are exempt from the requirements stated herein. 1.7 "Nurse" means an individual licensed in this state to practice nursing pursuant to the provisions of Chapter 5-34 of the General Laws of Rhode Island, as amended. 1.8 “Physician”, as used herein, means an individual licensed under the provisions of Chapter 5- 37 of the General Laws of Rhode Island, as amended, or an individual licensed to practice allopathic or osteopathic medicine under the laws of another state or territory of the United States, provided those laws are deemed to be substantially equivalent to Chapter 5-37 of the Rhode Island General Laws, as amended. 1.9 "Physician assistant" means a person, not a physician nor holding a medical doctor or equivalent degree, who is qualified by academic and practical training to provide those certain patient services in which he/she is trained under the supervision, control, responsibility and direction of a licensed physician. 1.10 "Practitioner", as used herein, means a physician, certified registered nurse practitioner, registered nurse, licensed practical nurse, or a physician assistant. 1.11 "Pre-employment health screening" means the review of health records, pertinent laboratory results, and other documentation of a health care worker performed by a licensed practitioner in order to determine that the health care worker is free of the communicable diseases cited in these regulations, and is also appropriately immunized, tested, and counseled prior to employment. Section 2.0 General Requirements 2.1 Health care facilities shall adopt, at a minimum, the standards of immunization and communicable disease testing and standards for pre-employment health screening contained in section 3.0 of these regulations. 3 2.2 It shall be the responsibility of the administrative head, or his/her designee, of any health care facility to secure compliance with these rules and regulations. 2.3 Each health care facility shall develop policies, procedures, and/or protocols for compliance with the pre-employment health screening requirements described herein. 2.4 In hospitals, active medical staff members, including all credentialed staff, may satisfy the requirements stated herein through documentation with hospital authorities at the time of initial credentialing and subsequent reappointments, or more frequently, if recommended by the policies of the hospital. 2.5 Transient employees not involved in direct patient contact or outside contractors not involved in direct patient contact are exempt from the requirements stated herein. 2.6 In licensed health care facilities, other than hospitals, non-employee staff, such as volunteers, who are involved in direct patient contact shall be exempt from the requirements stated herein. 2.7 Health care facilities and health care workers shall comply with additional immunization and screening requirements that the Director may prescribe from time to time in order to control communicable diseases. 2.8 Persons discovering communicable diseases (e.g., physicians, physician assistants, registered nurse practitioners), in the process of screening health care workers shall comply with the reporting requirements contained in the most current version of the Rules and Regulations Pertaining to the Reporting of Communicable, Environmental and Occupational Diseases of reference 3 herein and the most current version of the Guidelines for Prevention and Control of Communicable Diseases issued by the Division of Disease Prevention and Control at the Department. Section 3.0 Minimum Standards for Immunization and Communicable Disease Testing for Health Care Workers 3.1 A pre-employment health screening shall be required for each health care worker involved in direct patient contact. Acceptable evidence shall be provided by the health care worker that testing and/or immunization for the communicable diseases listed herein for pre- employment health screening have been completed. 3.1.1 A practitioner shall have responsibility for performance of the pre-employment health screening. Such a practitioner may be an employee of the facility where employment is sought or may be an independent practitioner. 3.1.2 Documentation of immunization and testing shall be provided by the practitioner to the health care worker as a permanent portable record on the "Rhode Island Department of Health, Medical Record of Adult Immunization and Testing" form (see Appendix "A" herein). 4 3.1.3 A health care worker who is not in compliance with these requirements shall be excluded from attending patients in a health care facility until the requirements are met. Immunization and Testing Requirements 3.2 Measles, Mumps and Rubella: Persons born before 1957 generally are considered to be immune to measles, mumps and rubella. For health care workers born on or after January 1, 1957 and in accordance with the guidelines set forth in the most current edition of The Red Book: Report of the Committee for Infectious Diseases and the Advisory Council on Immunization Practices (ACIP), evidence of immunity is required (with the exception of health care workers who receive a medical exemption) through: a) Documented record of immunization (as described in section 4.0 below); Two (2) doses for measles vaccine given at least four (4) weeks apart and one (1) dose for mumps and rubella. For all three (3) antigens, the first dose is required to have been administered after the first birthday; OR b) Serologic evidence of acquired immunity (i.e., laboratory report of positive IgG titers for measles, and mumps and rubella). 3.3 Tuberculosis (TB): Evidence that the health care worker is free of active tuberculosis based upon the results of a negative two-step tuberculin skin test shall be required. If documented evidence is provided by the health care worker that a two-step tuberculin skin test, performed within the most recent twelve (12) months prior to hire, was negative, the requirements of this section shall be met. a) Documentation shall include date and result of the tuberculin skin test (PPD), and reaction size in millimeters. b) If the PPD test is positive, or a previous one is known to have been positive, a physician's or other licensed practitioner's (acting within his/her scope of practice) certification that the health care worker is free of active disease shall be required. Such certification shall be based on documentation of adequate chemotherapy for TB disease or chemo-prophylaxis for latent TB infection in the past, and a current history of freedom from signs and symptoms of TB. In the absence of documentation of chemotherapy or chemo-prophylaxis, a negative chest X-ray shall be required for certification. The chest x-ray shall have been performed at any time after the most recent positive PPD test result. c) A physician, certified registered nurse practitioner, or a physician assistant may certify that the health care worker is currently free of TB based on his/her clinical judgement for complex cases or unusual circumstances that do not fit the above criteria. 3.4 Hepatitis B vaccination and testing: Health care facilities shall abide by the OSHA Blood Borne Pathogens Standard (29 CFR 1910-1030), including the offering of hepatitis B 5 vaccination along with all recommendations for infection control training and provision of protective equipment to those health care workers at risk. An exposure control plan shall be in place in all health care facilities licensed by the Department of Health, pursuant to the provisions of Chapter 23-17 of the General Laws, as amended. Employees at risk of exposure to blood-borne pathogens shall be offered hepatitis B vaccine within ten (10) days of employment. The hepatitis B vaccination series consists of three (3) doses of vaccine given as two (2) doses four (4) weeks apart followed by a third dose five (5) months after the second dose. It is recommended that a titer be performed one (1) to three (3) months after the last dose. Persons failing to develop a titer shall be offered a repeat three (3) dose series with follow up titers. Employees have the option of signing a standard OSHA declination form if they choose not to be vaccinated and should be counseled regarding risk. 3.5 Influenza: New employees starting work between October and March shall be offered vaccination with influenza vaccine. Also, each health care facility shall offer annual vaccination against influenza to all other health care workers involved in direct patient contact, including employees and volunteers. If the facility is a licensed long-term care facility, it shall be responsible for documenting and reporting to the Division of Disease Prevention & Control at the Department annually (by July 1st of each year): 1) the number of health care workers who are eligible for said vaccination; and 2) the number of health care workers who accept said vaccination. Further, the facility shall be responsible for providing, on an annual basis, to those health care workers having direct patient contact, staff education on the nature of influenza and the role of vaccination in controlling its spread. Section 4.0 Documentation of Immunity and Testing (Immunization Records) 4.1 Acceptable documentation of completion of immunizations shall include the day, month, year and type/name of each dose of vaccine administered. The record of such evidence shall be signed by a practitioner (the signature of the employee is not acceptable). 4.1.1 Acceptable documentation of completion of immunization consists of: (a) a "Rhode Island Department of Health, Medical Record of Adult Immunization and Testing"; or (b) an official immunization record card, school immunization record, medical passport, World Health Organization immunization record, or other official immunization records acceptable to the Director. Section 5.0 Exemptions 5.1 A health care worker may be exempt from the immunization requirements described herein provided that a physician, physician assistant, or certified registered nurse practitioner signs a medical exemption stating that the health care worker is exempt from a specific vaccine because of medical reasons, in accordance with Advisory Committee on Immunization Practices (ACIP) guidelines; or in accordance with contraindications identified by the manufacturer. 6 Section 6.0 Severability 6.1 If any provision of these rules and regulations or the application thereof to any person or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of the rules and regulations which can be given effect, and to this end the provisions of the rules and regulations are declared to be severable. 7 REFERENCES 1. CDC. General Recommendations on Immunizations: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR, February 8, 2002; 51 (RR02); 1--36. Available online at: www.cdc.gov/mmwr/preview/mmwrhtml/rr5102a1.htm and Recommendations on Measles, Mumps, and Rubella--Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps (dated May 22, 1998). 2. "Department of Health", Chapter 23-1 of the Rhode Island General Laws, as amended. 3. Rules and Regulations Pertaining to the Reporting of Communicable, Environmental and Occupational Diseases (R23-5-6, 10, 11, 23-24.6-CD/ERD and R23-24.5 ASB), Rhode Island Department of Health, April 1996. 4. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report, Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection, June 9, 2000. 5. "Blood Borne Pathogens", Occupational Safety and Health Administration (OSHA), 29 Code of Federal Regulations Part 1910-1000 to end, section 1910.1030, pp. 316-326, July 1, 1994. 6. Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Facilities, 1994, U.S. Department of Health & Human Services, Public Health Service, Centers for Disease Control & Prevention, October 28, 1994, vol. 43, no. RR-13. 7. The Red Book: Report on the Committee for Infectious Diseases. American Academy of Pediatrics, 2000 (published bi-annually). 8. Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC), U.S. Public Health Service, Centers for Disease Control, Morbidity & Mortality Weekly Report, December 26, 1997 / 46(RR-18);1-42. Available online at: www.cdc.gov/mmwr/preview/mmwrhtml/00050577.htm 9. Policy and Procedures for Tuberculosis Screening of Health-Care Workers. Francis J. Curry National Tuberculosis Center, 3180 18th Street, Suite 101, San Francisco, CA 94110-2028 (telephone: 415-502-4600 facsimile: 415-502-4620) available online at: www.nationaltbcenter.edu 10. "Licensing of Health Care Facilities", Chapter 23-17 of the Rhode Island General Laws, as amended. Wednesday, July 03, 2002 health care workers-final regs-july02.doc 8 Appendix "A" HEALTH CARE WORKER RECORD OF IMMUNIZATIONS and TESTING HEALTH CARE WORKER RECORD OF IMMUNIZATIONS and TESTING HEALTH CARE WORKER RECORD OF IMMUNIZATIONS and TESTING HEALTH CARE WORKER RECORD OF IMMUNIZATIONS and TESTING NAME: DATE OF BIRTH: NAME: DATE OF BIRTH: NAME: DATE OF BIRTH: NAME: DATE OF BIRTH: ADDRESS: ADDRESS: ADDRESS: ADDRESS: TELEPHONE NUMBER: Day Evening TELEPHONE NUMBER: Day Evening TELEPHONE NUMBER: Day Evening TELEPHONE NUMBER: Day Evening PROFESSION & license NUMBER (If Any) PROFESSION & license NUMBER (If Any) PROFESSION & license NUMBER (If Any) PROFESSION & license NUMBER (If Any) For pre-employment screening of health care workers: For pre-employment screening of health care workers: For pre-employment screening of health care workers: For pre-employment screening of health care workers: VACCINE or TEST: VACCINE or TEST: VACCINE or TEST: VACCINE or TEST: Date(s): Date(s): Date(s): Date(s): Results: Results: Results: Results: Signature/Address of practitioner(s) who administered Signature/Address of practitioner(s) who administered Signature/Address of practitioner(s) who administered Signature/Address of practitioner(s) who administered or verified administration of vaccine or read lab results: or verified administration of vaccine or read lab results: or verified administration of vaccine or read lab results: or verified administration of vaccine or read lab results: MMR MMR MMR MMR Titer result: Measles Titer result: Measles Titer result: Measles Titer result: Measles Titer result: Mumps Titer result: Mumps Titer result: Mumps Titer result: Mumps Titer result: Rubella Titer result: Rubella Titer result: Rubella Titer result: Rubella PPD (result in mm) PPD (result in mm) PPD (result in mm) PPD (result in mm) Hepatitis B vaccine (if more than 3--write Hepatitis B vaccine (if more than 3--write Hepatitis B vaccine (if more than 3--write Hepatitis B vaccine (if more than 3--write dates in comment area dates in comment area dates in comment area dates in comment area)+ Hepatitis B titer result Hepatitis B titer result Hepatitis B titer result Hepatitis B titer result Influenza Influenza Influenza Influenza+ + This vaccine must be offered offered offered offered to health care workers. Reproduce form in duplicate: one copy for the employer's file, and the original stays with the health care worker. Reproduce form in duplicate: one copy for the employer's file, and the original stays with the health care worker. Reproduce form in duplicate: one copy for the employer's file, and the original stays with the health care worker. Reproduce form in duplicate: one copy for the employer's file, and the original stays with the health care worker. Note: Federal regulations require Note: Federal regulations require Note: Federal regulations require Note: Federal regulations require vaccine name, lot number and expiration date recorded in patient's chart by person administering vaccine. Such information is not needed on this vaccine name, lot number and expiration date recorded in patient's chart by person administering vaccine. Such information is not needed on this vaccine name, lot number and expiration date recorded in patient's chart by person administering vaccine. Such information is not needed on this vaccine name, lot number and expiration date recorded in patient's chart by person administering vaccine. Such information is not needed on this form. form. form. form.