BILL NUMBER: SB 1318AMENDED BILL TEXT AMENDED IN ASSEMBLY AUGUST 8, 2012 AMENDED IN ASSEMBLY AUGUST 7, 2012 AMENDED IN ASSEMBLY JUNE 14, 2012 AMENDED IN SENATE MAY 25, 2012 AMENDED IN SENATE APRIL 11, 2012 INTRODUCED BY Senator Wolk (Coauthor: Senator Anderson) FEBRUARY 23, 2012 An act to add Sections 1228.3, 1228.5, and 1288.65 Section 1228.5 to, and to repeal and add Section 1288.7 of, the Health and Safety Code, relating to infectious diseases. LEGISLATIVE COUNSEL'S DIGEST SB 1318, as amended, Wolk. Health facilities: influenza vaccinations. Existing law imposes on the State Department of Public Health various duties and responsibilities regarding the regulation of clinics and health facilities, including general acute care hospitals, as defined. Existing law requires a general acute care hospital to annually offer onsite influenza vaccinations, if available, to all hospital employees. Existing law requires a general acute care hospital to require its employees to be vaccinated, or if the employee elects not to be vaccinated, to declare in writing that he or she declined the vaccination. A violation of these provisions is punishable as a misdemeanor. This bill would require licensed clinics and health facilities to institute measures, including aerosol transmissible diseases training, designed to maximize influenza vaccination rates and to prevent onsite health care workers affiliated with the clinic or health facility and persons with privileges on the medical staff from contracting, and transmitting to patients, the influenza virus. This bill would require each clinic and health facility to annually offer onsite influenza vaccinations to its employees and to require its onsite health care workers affiliated with the clinic or health facility, as defined, and persons with privileges on the medical staff, as defined, to be vaccinated. This bill would require each clinic and health facility to annually record its vaccination rate, as defined, for each year and to make those records available online or upon request. This bill would require licensed clinics and health facilities to maintain vaccination records of their employees and permit licensed clinics and health facilities to require documentation of vaccination or vaccination refusal from an onsite health care worker or person with privileges on the medical staff. By increasing the responsibilities of clinics and health facilities, and adding instances where a clinic or health facility could be subject to a misdemeanor, this bill would expand the definition of a crime and would impose a state-mandated local program. This bill would also require each clinic and health facility to develop policies to implement these provisions and to ensure nonmedical staff, as defined, compliance with vaccination requirements. This bill would require the medical staff to develop separate policies to ensure compliance with vaccination requirements imposed by the clinic or health facility. This bill would require clinics and health facilities to report their percentage of employees and medical staff and of medical staff who have been vaccinated for that year to the State Department of Public Health. This bill would provide that a clinic or health facility that reports, by January 1, 2015, a combined average of 90% or higher vaccination rate for its employees and medical staff shall not be subject to specified implementation and compliance requirements. This bill would require the department, by January 1, 2016, to develop a model mandatory vaccination policy, as specified, and would require clinics and health facilities which fail to reach the 90% compliance rate requirement to be subject to the model mandatory vaccination policy require, commencing January 1, 2015, each clinic and health facility to have a 90% or higher vaccination rate. The bill would require the department, by July 1, 2015, to develop a model mandatory vaccination policy, as specified, and for each year a clinic or health facility does not achieve the 90% or higher vaccination rate, would require the clinic or health facility to adopt the model mandatory vaccination policy for the following flu season . The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. The Legislature declares that influenza can be a serious disease that can lead to hospitalization and even death, and that increased access to vaccinations is a critical component in the promotion of health and wellness. Because of their contact with patients, many health care workers are at risk for exposure to, and possible transmission of, vaccine-preventable diseases. By getting vaccinated, health care workers can protect themselves, their families, and patients from contracting the flu. It is the intent of the Legislature in enacting this statute to protect the health, safety, and welfare of health care workers and patients who enter a clinic or health care facility. It is also the intent of the Legislature that health care facilities and clinics institute measures designed to maximize influenza vaccination rates and increase vaccination among health care workers. It is also the intent of the Legislature that the State Department of Public Health develop a model mandatory vaccination policy through a stakeholder process to achieve a 90-percent influenza vaccination compliance rate requirement for health care workers. SEC. 2. Section 1228.3 is added to the Health and Safety Code, to read: 1228.3. (a) A licensed clinic shall institute measures designed to maximize influenza vaccination rates and to prevent persons with privileges on the medical staff and onsite health care workers affiliated with the clinic from contracting, and transmitting to patients, the influenza virus to patients. These measures shall include, but not be limited to, aerosol transmissible diseases training as described in Section 5199(i) of Title 8 of the California Code of Regulations, as in effect on January 1, 2013. (b) For purposes of this section, the following definitions shall apply: (1) "Medical staff" shall have the same meaning provided in Section 1228.5. (2) "Onsite health care worker affiliated with the clinic" shall have the same meaning provided in Section 1228.5. (c) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement this section by sending letters or similar instruction to all applicable facilities without taking regulatory action. SEC. 3. SEC. 2. Section 1228.5 is added to the Health and Safety Code, to read: 1228.5. (a) A licensed clinic shall institute measures designed to maximize influenza vaccination rates and to prevent persons with privileges on the medical staff and onsite health care workers affiliated with the clinic from contracting, and transmitting to patients, the influenza virus. These measures shall include, but not be limited to, aerosol transmissible diseases training as described in subdivision (i) of Section 5199 of Title 8 of the California Code of Regulations, as in effect on January 1, 2013. (b) A licensed clinic shall annually offer its employees onsite influenza vaccinations, if available, at no cost to the employee. (b) (c) A licensed clinic shall require all onsite health care workers affiliated with the clinic and persons with privileges on the medical staff to either annually receive an influenza vaccination or, as an alternative to the annual influenza vaccination if an onsite health care worker affiliated with the clinic or person with privileges on the medical staff elects not to be vaccinated, he or she shall agree, in writing, to adhere to the most effective measures determined by the clinic in preventing health care workers from contracting and transmitting the influenza virus. (d) (1) A clinic shall annually record its average vaccination compliance rate, as defined in paragraph (4) of subdivision (i), for that year, and make those records available online or upon request of a government agency, organization, or individual. (2) The records described in paragraph (1) shall be maintained and made available during any inspection made by the department. (e) (1) Commencing January 1, 2015, a clinic shall have a 90-percent or higher vaccination rate. For each year that a clinic does not achieve the 90-percent or higher vaccination rate, the clinic shall adopt for the following flu season, as defined by the State Health Officer, local health officer, or both, the model mandatory vaccination policy described in paragraph (2), to achieve the 90-percent or higher goal. The department may waive the 90-percent vaccination rate requirement for a clinic that is in substantial compliance. (2) The department shall develop a model mandatory vaccination policy through a stakeholder process to be issued through an all facilities letter no later than July 1, 2015. (c) (f) (1) In meeting the requirements of subdivision (b) subdivisions (c), (d), and (e) , the clinic shall maintain influenza vaccination records of employees and may maintain influenza vaccination records of the other onsite health care workers who are affiliated with, but are not an employee employees of, the clinic and of persons with privileges on the medical staff. If the clinic does not have records of an onsite health care worker or person with privileges on the medical staff being vaccinated onsite, the clinic may require the worker or medical staff person to either provide documentation of vaccination or documentation that he or she refused the vaccination. (2) The clinic may include language in its business contracts to require a contract worker to maintain records of the verification of offsite vaccination or documentation that he or she refused the vaccination, which shall be available to the clinic upon request. Nothing in this section shall be construed to require a clinic to maintain separate vaccination records or to provide vaccinations at no cost to a contract worker who is not an employee of the clinic. (d) (g) Each licensed clinic shall develop policies to implement this section and to ensure its onsite health care workers affiliated with the clinic are in compliance with the vaccination requirements imposed by this section. The medical staff shall also develop policies to ensure that persons who have privileges on the medical staff are in compliance with the vaccination requirements of this section that have been implemented by the clinic. (h) Subdivisions (f) and (g) shall not be applicable to a dialysis clinic which maintains an influenza immunization log for its patients, health care workers, and medical staff pursuant to an infection control program in compliance with the Medicare "Conditions for Coverage for End-State Renal Disease Facilities," conditions that are promulgated by the Centers for Medicare and Medicaid Services, if the immunization log is available for review during routine department inspections or during an inspection in response to a complaint. (e) (i) For purposes of this section, the following definitions shall apply: (1) "Employee" means an individual who works for the clinic, is listed on the clinic's payroll records, and is under the clinic's direction and control. (2) "Medical staff" means professional medical personnel who are approved and given privileges to provide health care to patients while onsite in a clinic and who are responsible for the adequacy and quality of care rendered to patients. Medical staff includes, but is not limited to, physicians and surgeons, and, if dental or podiatric services are provided, dentists or podiatrists. (3) "Onsite health care worker affiliated with the clinic" means a person who is either a volunteer or is employed by, paid by, or receives credit or any other form of compensation from the clinic, who performs some or all of his or her duties in a patient care area of the facility. The patient care area of the facility shall be determined by the clinic and is where onsite health care workers and medical staff are within close proximity to patients receiving care. An onsite health care worker affiliated with the clinic includes, but is not limited to, employees, physicians, nurses, nursing assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, laboratory personnel, autopsy personnel, students and trainees, contractual staff, and registry staff who perform direct patient care duties but are not employed by the clinic. (4) "Vaccination rate" means the percentage of a clinic's onsite health care workers who are employees and persons with privileges on the medical staff who receive influenza vaccination during a specific year or influenza season. (f) (j) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement this section by sending letters or similar instruction to all applicable facilities without taking regulatory action. (g) A clinic shall annually report its average vaccination compliance rate for onsite health care workers who are employees and of medical staff who have been vaccinated for that year to the State Department of Public Health. (h) This section, with the exception of subdivision (a) and the reporting requirement of subdivision (g), shall not apply to a clinic that has a combined average vaccination compliance rate of 90 percent or higher, by January 1, 2015, for its onsite health care workers who are employees and medical staff. For clinics that fail to reach the 90-percent compliance rate requirement, the clinic shall adopt the model mandatory vaccination policy as determined by the State Department of Public Health to achieve the 90-percent or higher goal. The department shall develop a model mandatory vaccination policy through a stakeholder process to be issued through an all facilities letter no later than January 1, 2016. The department may waive the 90-percent compliance rate requirement for a clinic that is in substantial compliance. Implementation of this section shall be exempt from the Administrative Procedure Act. (k) This section does not to prevent a clinic or local jurisdiction from instituting additional measures or policies to maximize influenza vaccination rates and to prevent health care workers affiliated with the clinic from contracting and transmitting the influenza virus. (l) This section does not require the department to perform any additional duties to ensure compliance that are separate from its existing licensing survey activity or other statutory requirements. (m) Implementation of this section is exempt from the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). SEC. 4. Section 1288.65 is added to the Health and Safety Code, to read: 1288.65. (a) A licensed health facility shall institute measures designed to maximize influenza vaccination rates and to prevent persons with privileges on the medical staff and onsite health care workers affiliated with the health facility from contracting, and transmitting to patients, the influenza virus. These measures shall include, but not be limited to, aerosol transmissible diseases training, as described in Section 5199(i) of Title 8 of the California Code of Regulations, as in effect January 1, 2013. (b) For purposes of this section, the following definitions shall apply: (1) "Medical staff" means professional medical personnel who are approved and given privileges to provide health care to patients in a health facility and who are responsible for the adequacy and quality of care rendered to patients. Medical staff includes, but is not limited to, physicians and surgeons, and, if dental or podiatric services are provided, dentists or podiatrists. (2) "Onsite health care worker affiliated with the health facility" means a person who is either a volunteer or is employed by, paid by, or receives credit or any other form of compensation from the health facility, who performs some or all of his or her duties in a patient care area of the facility. The patient care area of the facility shall be determined by the health facility and is where onsite health care workers and medical staff are within close proximity to patients receiving care. An onsite health care worker affiliated with the health facility includes, but is not limited to, employees, physicians, nurses, nursing assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, laboratory personnel, autopsy personnel, students and trainees, contractual staff, and registry staff who perform direct patient care duties but are not employed by the health facility. (c) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement this section by sending letters or similar instruction to all applicable facilities without taking regulatory action. SEC. 5. SEC. 3. Section 1288.7 of the Health and Safety Code is repealed. SEC. 6. SEC. 4. Section 1288.7 is added to the Health and Safety Code, to read: 1288.7. (a) A licensed health facility shall institute measures designed to maximize influenza vaccination rates and to prevent persons with privileges on the medical staff and onsite health care workers affiliated with the health facility from contracting, and transmitting to patients, the influenza virus. These measures shall include, but not be limited to, aerosol transmissible diseases training as described in subdivision (i) of Section 5199 of Title 8 of the California Code of Regulations, as in effect on January 1, 2013. (b) A licensed health facility shall annually offer its employees onsite influenza vaccinations, if available, at no cost to the employee. (b) (c) A licensed health facility shall require all onsite health care workers affiliated with the health facility and persons with privileges on the medical staff to either annually receive an influenza vaccination or, as an alternative to the annual influenza vaccination if the onsite health care worker affiliated with the health facility or person with privileges on the medical staff elects not to be vaccinated, he or she shall agree, in writing, to adhere to the most effective measures determined by the health facility in preventing health care workers from contracting and transmitting the influenza virus. (d) (1) A health facility shall annually record its vaccination rate, as defined in paragraph (4) of subdivision (i), for that year, and make those records available online or upon request of a government agency, organization, or individual. (2) The records described in paragraph (1) shall be maintained and made available during any inspection made by the department. (e) (1) Commencing January 1, 2015, a health facility shall have a 90-percent or higher vaccination rate. For each year that a health facility does not achieve the 90-percent or higher vaccination rate, the health facility shall adopt for the following flu season, as defined by the State Health Officer, local health officer, or both, the model mandatory vaccination policy described in paragraph (2), to achieve the 90-percent or higher goal. The department may waive the 90-percent vaccination rate requirement for a health facility that is in substantial compliance. (2) The department shall develop a model mandatory vaccination policy through a stakeholder process to be issued through an all facilities letter no later than July 1, 2015. (c) (f) (1) In meeting the requirements of subdivision (b) subdivisions (c), (d), and (e) , the health facility shall maintain influenza vaccination records of employees and may maintain influenza vaccination records of the other onsite health care workers who are affiliated with, but are not employees of, the health facilities and of persons with privileges on the medical staff. If the health facility does not have records of an onsite health care worker or person with privileges on the medical staff being vaccinated, the health facility may require the worker or medical staff person to either provide documentation of vaccination or documentation that he or she refused the vaccination. (2) The health facility may include language in its business contracts to require a contract worker to maintain records of the verification of offsite vaccination or documentation that he or she refused the vaccination, which shall be available to the health facility upon request. Nothing in this section shall be construed to require a health facility to maintain separate vaccination records or to provide vaccinations at no cost to a contract worker who is not an employee of the health facility. (d) (g) Each licensed health facility shall develop policies to implement this section and to ensure its onsite health care workers affiliated with the health facility are in compliance with the vaccination requirements imposed by this section. The medical staff shall develop policies to ensure that persons who have privileges on the medical staff are in compliance with the vaccination requirements of this section that have been implemented by the health facility. (e) (h) In addition to other requirements of this section, general acute care hospitals shall take all of the following actions: (1) Institute respiratory hygiene and cough etiquette protocols, develop and implement procedures for the isolation of patients with influenza, and adopt a seasonal influenza plan. (2) Revise an existing or develop a new disaster plan that includes a pandemic influenza component. The plan shall also document any actual or recommended collaboration with local, regional, and state public health agencies or officials in the event of an influenza pandemic. (f) (i) For purposes of this section, the following definitions shall apply: (1) "Employee" means an individual who works for the health facility, is listed on the health facility's payroll records, and is under the health facility's direction and control. (2) "Medical staff" means professional medical personnel who are approved and given privileges to provide health care to patients in a health facility and who are responsible for the adequacy and quality of care rendered to patients. Medical staff include includes, but is not limited to, physicians and surgeons, and , if dental or podiatric services are provided, dentists or podiatrists. (3) "Onsite health care worker affiliated with the health facility" means a person who is either a volunteer or is employed by, paid by, or receives credit or any other form of compensation from the health facility, who performs some or all of his or her duties in a patient care area of the facility. The patient care area of the facility shall be determined by the health facility and is where onsite health care workers and medical staff are within close proximity to patients receiving care. An onsite health care worker affiliated with the health facility includes, but is not limited to, physicians, nurses, nursing assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, laboratory personnel, autopsy personnel, students and trainees, contractual staff , and registry staff performing direct patient care duties but are not employed by the health facility. (4) "Vaccination rate" means the percentage of a health facility's onsite health care workers who are employees and persons with privileges on the medical staff who receive an influenza vaccination during a specific year or influenza season. (g) (j) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement this section by sending letters or similar instruction to all applicable facilities without taking regulatory action. (h) A health facility shall annually report its average vaccination compliance rate of onsite health care workers that are employees and of medical staff who have been vaccinated for that year to the State Department of Public Health. (i) This section, with the exception of subdivisions (a) and (e), and the reporting requirement of subdivision (h), shall not apply to health facilities that have a combined average vaccination compliance rate of 90 percent or higher by January 1, 2015, for its onsite health care workers that are employees and medical staff. For health facilities that fail to reach the 90-percent compliance rate requirement, the health facility shall adopt the model mandatory vaccination policy as determined by the State Department of Public Health to achieve the 90-percent or higher goal. The department shall develop a model mandatory vaccination policy through a stakeholder process to be issued through an all facilities letter later no later than January 1, 2016. The department may waive the 90-percent compliance rate requirement for a health facility that is in substantial compliance. Implementation of this section shall be exempt from the Administrative Procedure Act. (k) This section does not apply to correctional treatment centers as defined in subdivision (j) of Section 1250. (l) This section does not prevent a health facility or local jurisdiction from instituting additional measures or policies to maximize influenza vaccination rates and to prevent health care workers affiliated with the health facility from contracting and transmitting the influenza virus. (m) This section does not require the department to perform any additional duties to ensure compliance that are separate from its existing licensing survey activity or other statutory requirements. (n) Implementation of this section is exempt from the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). SEC. 7. SEC. 5. No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.