BILL ANALYSIS Ó SB 1318 Page 1 Date of Hearing: June 26, 2012 ASSEMBLY COMMITTEE ON HEALTH William W. Monning, Chair SB 1318 (Wolk) - As Amended: June 14, 2012 SENATE VOTE : 23-9 SUBJECT : Health facilities: flu vaccinations. SUMMARY : Requires licensed clinics and licensed health care facilities, commencing on January 1, 2015, to require onsite health care workers affiliated with the clinic and health care facility and persons with privileges on the medical staff to either annually receive an influenza (flu) vaccination or, as an alternative wear a clinic and health facility-provided surgical or procedural mask, as specified, while performing their duties in any patient care area during the flu season, as defined. Specifically, this bill : 1)Declares that mandatory mask-wearing policies for health care workers who have not been immunized have proven effective to increase vaccination rates in health care workers. States that while studies have not yet proven that masking is effective to protect transmission of flu in the asymptomatic phase of the flu illness, wearing a mask has proven effective in preventing the transmission of other respiratory pathogens. 2)Requires clinics and health care facilities to institute measures designed to maximize flu 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 flu virus. States that these measures shall include, but not be limited to, aerosol transmissible diseases training (ATD), as specified. 3)Requires clinics and health care facilities to annually offer employees onsite flu vaccinations, if available, at no cost to the employee. 4)Requires clinics and health care facilities to require all onsite health care workers affiliated with the clinic and health care facility and persons with privileges on the medical staff to either annually receive a flu vaccination or, SB 1318 Page 2 as an alternative wear a clinic- and health care facility-provided surgical or procedural mask, or other mask that covers the mouth and nose area of the face, while performing his or her duties in any patient care area of the clinic and health care facility during the flu season, as defined by the State Health Officer or a local health officer (LHO), or both. 5)Provides that in meeting the requirements of 4) above, clinics and health care facilities: a) Must maintain flu vaccination records of employees and may maintain flu vaccination records of the other onsite health care workers affiliated with, but who are not employees of, the clinic and of persons with privileges on the medical staff. If the clinic and health care facility do not have records of an onsite health care worker or person with privileges on the medical staff being vaccinated onsite, they may require the worker or medical staff person to either provide documentation of vaccination or documentation that he or she refused the vaccination. b) Allow language to be included 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 and require this documentation be made available to the clinic and health care facility upon request. The clinic and health care facility are not required to maintain separate vaccination records or to provide vaccinations at no cost to a contract worker who is not an employee of the clinic and health care facility. 6)Requires each clinic and health facility to develop policies to comply with items 3) through 5) above and to ensure its onsite health care workers affiliated with the clinic are in compliance with the vaccination requirements. Requires the medical staff to 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 and health care facility. 7)Defines the following terms: a) "Employee" means an individual who works for the clinic, is listed on the payroll records, and is under the clinic's SB 1318 Page 3 direction and control. b) "Medical staff" means professional medical personnel who are approved and given privileges to provide health care to patients while onsite in a clinic and health care facility and who are responsible for the adequacy and quality of care rendered to patients. Includes, but is not limited to, physicians and surgeons, and, if dental or podiatric services are provided, dentists or podiatrists. c) "Onsite health care worker affiliated with the clinic and health care 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 clinic and health care 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 clinic and health care facility and is where onsite health care workers and medical staff are within close proximity to patients receiving care. 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 and health care facility. 8)Allows the Department of Public Health (DPH) to implement this bill by sending letters or similar instruction to all applicable facilities without taking regulatory action. 9)Requires a clinic and health care facility to annually report their average vaccination compliance rate for onsite health care workers who are employees and of medical staff who have been vaccinated for that year to DPH. 10)Requires, in addition to the other requirements of this bill, general acute care hospitals to also do the following: a) Institute respiratory hygiene and cough etiquette protocols, develop and implement procedures for the isolation of patients with flu, and adopt a seasonal flu plan; and, SB 1318 Page 4 b) Revise an existing or develop a new disaster plan that includes a pandemic flu component. Requires the plan to also document any actual or recommended collaboration with local, regional, and state public health agencies or officials in the event of a flu pandemic. 11)Makes this bill operative on January 1, 2015. 12)Sunsets existing law that requires DPH to require each general acute care hospital to offer onsite flu vaccinations, if available to all hospital employees at no cost to the employee by January 1, 2015. 13)Exempts from the provisions of this bill, except for the reporting of compliance rate as specified in 9) above, clinics that have a combined average vaccination compliance rate of 90% or higher for its onsite health care workers who are employees and medical staff. 14)Exempts health care facilities that have a combined average vaccination compliance rate of 90% or higher for its onsite health care workers that are employees and medical staff from: a) The requirement to annually offer its employees flu vaccinations; b) The additional requirements for general acute care hospitals, specified in 10) above; and c) The reporting of compliance rate as specified in 9) above. EXISTING LAW : 1)Provides for the licensure and regulation of clinics and health facilities, including acute care hospitals by DPH. 2)Defines a clinic as an organized outpatient health facility that provides direct medical, surgical, dental, optometric, or podiatric advice, services, or treatment to patients who remain less than 24 hours, and that may also provide diagnostic or therapeutic services to patients in the home as an incident to care provided at the clinic facility. 3)Defines a health facility as any facility, place, or building SB 1318 Page 5 that is organized, maintained, and operated for the diagnosis, care, prevention, and treatment of human illness, physical or mental, including convalescence and rehabilitation and including care during and after pregnancy, or for any one or more of these purposes, for one or more persons, to which the persons are admitted for a 24-hour stay or longer, and includes: general acute care hospitals, acute psychiatric hospitals, skilled nursing facilities, several categories of intermediate care facilities, congregate living health facilities, correctional treatment centers, as defined, and nursing facilities. 4)Requires DPH to require each general acute care hospital, in accordance with the Centers for Disease Control and Prevention (CDC) Guidelines to take all of the following actions: a) Annually offer onsite flu vaccinations, if available, to all hospital employees at no cost to the employee; b) Require its employees to be vaccinated, or if the employee elects not to be vaccinated, to declare in writing that he or she has declined the vaccination; c) Institute respiratory hygiene and cough etiquette protocols, develop and implement procedures for the isolation of patients with flu, and adopt a seasonal flu plan; and, d) Revise an existing or develop a new disaster plan that includes a pandemic flu component. Requires the plan to also document any actual or recommended collaboration with local, regional, and state public health agencies or officials in the event of a flu pandemic. FISCAL EFFECT : According to the Senate Appropriations Committee, potential increased costs to review compliance by clinics, up to $150,000 (Licensing and Certification Fund). DPH may need additional resources to review hospital and clinic records of vaccinations by employees and others. Because DPH already performs periodic inspections of health facilities as part of its licensing program, total additional costs to gather this information is not likely to be significant. COMMENTS : SB 1318 Page 6 1)PURPOSE OF THIS BILL . The California Medical Association, the Health Officers Association of California, and the California Association for Nurse Practitioners are the sponsors of this bill. According to the author, this bill ensures that all health care workers in clinics and health facilities, including physicians, either receive the flu vaccination or wear a mask in an effort to help prevent the spread of the flu virus, and protect vulnerable patients. According to the CDC, health care workers who get vaccinated reduce the transmission of flu, staff illness, and absenteeism, and flu-related illness and death, especially among people in health care facilities who are at increased risk for severe flu illnesses. Additionally, reports have shown that higher vaccination levels among staff have been associated with a lower risk of hospital-acquired flu cases, while lower flu vaccination rate have led to greater number of flu outbreaks in hospitals and long term care facilities. Nationwide, the CDC notes that during the 2010-11 flu season, coverage for flu vaccination among health care workers was estimated at 63.5%. However, vaccination rates for health care workers who had an employer requirement were at 98.1%. This discrepancy shows the success of these mandatory vaccination programs. The United States Health and Human Services (HHS) has a 90% vaccination rate goal for health care personnel (HCP) by 2020. 2)BACKGROUND . a) Flu . According to the CDC, the flu is a contagious respiratory illness caused by viruses that infect the nose, throat, and lungs. It can cause mild to severe illness, and at times can lead to death. Most experts believe that flu viruses spread mainly by droplets made when people with flu cough, sneeze, or talk, which can land in the mouths or noses of people who are nearby. Less often, a person might also get flu by touching a surface or object that has flu virus on it and then touching their own mouth, eyes, or possibly their nose. The flu can be passed to someone else before symptoms appear, as well as while a person is symptomatic. Most healthy adults may be able to infect others beginning one day before symptoms develop and up to five to seven days after becoming sick. Some people, especially young children and people with weakened immune systems, might be able to infect others for an even longer time. There are a number of groups of people considered at high risk to develop flu-related complications, including: SB 1318 Page 7 children younger than five, but especially children younger than two years old; adults over 65 years of age; pregnant women; and, people with certain medical conditions (including asthma, neurological and neurodevelopmental conditions, chronic lung disease, heart disease, blood disorders, diabetes, kidney disorders, liver disorders, and weakened immune systems). b) Flu vaccine . According to the CDC, the single best way to prevent the flu is to get a flu vaccine each season. There are two types of flu vaccines: flu shots, which are inactivated vaccines that are given with a needle and the nasal-spray flu vaccine (a vaccine made with live, weakened flu viruses that is given as a nasal spray. About two weeks after vaccination, antibodies develop that protect against flu virus infection. Driven by the H1N1 pandemic, in February 2010, the Advisory Committee on Immunization Practices (ACIP) voted to recommend that all people six months and older should obtain a flu vaccine (universal recommendation for vaccination). ACIP and the Healthcare Infection Control Practices Advisory Committee (HICPAC) also recommend that all health care workers get vaccinated annually against flu. According to the CDC, health care workers include, but are 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 not employed by the health care facility, and persons (e.g., clerical, dietary, housekeeping, laundry, security, maintenance, administrative, billing, and volunteers) not directly involved in patient care but potentially exposed to infectious agents that can be transmitted to and from health care workers and patients. According to DPH, the mean hospital-specific employee vaccination percentage in California was 55% in 2008-09 and has grown since: 63% in 2009-10 and 64.3% in 2010-11. The goal of HHS is a 90% vaccination rate by 2020. c) Flu Vaccination among HCP . SB 739 (Speier), Chapter 526, Statutes of 2006, among other provisions, requires: DPH to require each general acute care hospital to annually offer onsite flu vaccinations, if available, to all hospital employees at no cost to the employee; hospital employees to be vaccinated, or if an employee elects not to SB 1318 Page 8 be vaccinated, to declare in writing that he or she declines the vaccination; hospitals to adopt a seasonal flu plan; and, report to DPH implementation of SB 739 requirements, including the percentage of those who are vaccinated. Pursuant to SB 739, in 2011, DPH published a report entitled "Flu Vaccination among Health Care Personnel in California General Acute Care Hospitals for the 2010-2011 Respiratory Season (DPH Report)." The DPH Report indicated that "the 2010-11 flu season was the third for which hospitals submitted flu vaccination information. The flu season is defined as September 1, 2010 through March 31, 2011. The mean hospital-specific employee vaccination percentage of 64.3% was only modestly higher compared with 2008-09 (55%) and 2009-10 (63%). This indicates that the statewide mandatory written declination policy has not significantly increased hospital HCP flu vaccination coverage. Half of California hospitals failed to meet the Healthy People 2010 target of 60% HCP vaccination, and few reached the Healthy People 2020 target of 90%." The DPH Report also indicated that flu vaccination surveillance data for non-employee HCP was incomplete, with the vaccination status for more than 50% of some non-employee personnel categories remaining unknown. A comprehensive online survey conducted by DPH on flu vaccination policies and practices revealed that hospitals are using strategies recommended by HICPAC and ACIP to promote flu vaccination among HCP. These strategies include comprehensive flu vaccination campaigns, multiple vaccination opportunities during all shifts, education on flu and vaccination, and including all personnel in vaccination promotion strategies and vaccination opportunities. Hospitals that met the Healthy People 2020 target of 90% were more likely to use a mandatory participation vaccination policy with multiple enforcement strategies. However, fewer than 5% of hospitals exceeded 90% vaccination coverage, indicating that meeting the Healthy People 2020 target may not be feasible without some form of mandatory vaccination policy. The DPH Report also pointed out that the H1N1 pandemic in 2009-10 failed to increase appreciable HCP vaccination coverage, and transmission of H1N1 flu was documented among HCP. SB 1318 Page 9 The following recommendations were contained in the DPH Report which could improve flu vaccination coverage among HCP in California general acute care hospitals: i) Hospitals should consider more rigorous flu vaccination policies, such as mandatory participation or vaccination, to increase flu vaccination percentages. ii) Hospitals should ensure that flu vaccination status is a requirement of contracts with physician groups, registry organizations, fellowships, and student training programs. iii) Hospitals should account for the vaccination status of all non-employee HCP, including registry and contract personnel, students, and trainees. iv) Hospitals should implement robust data collection and management systems to document the vaccination status of all HCP. d) Counties with Mandatory Masking Policies . According to background information submitted by the author, the counties of San Francisco, Yolo, and Sacramento have masking policies that are similar to those proposed by this bill. In July 2011, the LHOs of Sacramento and Yolo counties sent letters to all hospitals, physicians, medical practices, community clinics, and ambulatory care centers that stated, in part: Vaccination of healthcare workers reduces infection and absenteeism among them, prevents mortality in their patients, and results in financial savings to sponsoring health institutions. The best way to prevent transmission of a disease like flu to those persons we serve is to mandate vaccination of healthcare workers and there are now two laws in California requiring flu vaccine for healthcare workers and other personnel at hospitals (CA Health & Safety Code §1288.7, effective January 1, 2007 and §5199 Aerosol Transmissible Diseases standard of Cal OSHA, effective September 1, 2010). In addition to full adherence to these laws, I am SB 1318 Page 10 requiring that all healthcare workers either receive the flu vaccine or wear a mask during flu season. All inpatient and ambulatory healthcare facilities in (Sacramento and Yolo) must implement a masking program, requiring that all healthcare workers who do not receive the flu vaccine wear a mask for the duration of the flu season while working in their facility. I am also recommending that healthcare administrators adopt an easy way to identify the healthcare workers who have received their flu vaccine. One example of this type of concept is to place a sticker on the healthcare worker's badge following vaccination. In September 2011, the San Francisco LHO sent a substantially similar letter, and also stated that this was already the policy at University of California, San Francisco (UCSF) Medical Center, San Francisco General Hospital, Laguna Honda Hospital, and Kaiser San Francisco. UCSF Medical Center's masking policy was instituted in 2009 and requires anyone who declines a flu vaccination to wear a protective mask, supplied by UCSF, while in patient care areas, which is specified as places where patients are seen, evaluated, and treated as well as in lobbies and waiting rooms. According to the Immunization Action Coalition, as of November 1, 2010, there were at least 16 other hospitals in California with masking policies. In September 2011, Kaiser North Valley (KNV) implemented a "flu vaccine mask policy." All physicians were sent an email stating that they were required to get the flu vaccine or wear a mask while in patient care areas of the KNV hospitals and clinics. In Kaiser facilities in those counties with masking requirements, personnel who are not compliant with the mask requirement in mandated counties were to be removed from working in patient care areas. e) National recommendations . A number of national organizations have recommendations for mandatory flu vaccines for healthcare workers, including the American Academy of Pediatrics, the American Medical Directors Association, and the American Pharmacists Association. Some organizations support immunization as a condition of employment and/or masking policies, including the American Academy of Family Physicians, the American College of Physicians, the American Hospital Association, the Association for Professionals in Infection Control and SB 1318 Page 11 Epidemiology, the Infectious Diseases Society of America, and the National Business Group on Health. The CDC, ACIP, and HICPAC recommend that all U.S. health care workers get vaccinated annually against flu. CDC points out those health care workers who get vaccinated help reduce the transmission of flu, staff illness and absenteeism, and flu-related illness and death, especially among people at increased risk for severe flu illness. Higher vaccination levels among staff have been associated with lower risk of hospital-acquired flu cases; flu outbreaks in hospitals and long-term care facilities have been attributed to low flu vaccination coverage among health care workers in those facilities; and higher flu vaccination levels among health care workers can reduce flu-related illness, and even deaths, in settings like nursing homes. f) Aerosol Transmissible Diseases (ATD) Regulations . In 2009, ATD regulations were adopted by the California Occupational Safety and Health Administration (Cal/OSHA) to create an occupational safety standard requiring certain protections for workers who may be exposed to ATD. The ATD standard is not for seasonal flu, although it would cover new variants of flu (swine and bird flu, for example). The ATD standards apply to various facilities, including hospitals, skilled nursing facilities, clinics, home health care, long term care facilities, and medical transport. Among other things, the ATD regulations require health facilities to establish, implement, and maintain an effective, written ATD Exposure Control Plan which is specific to the workplace or operations. While the ATD regulations are meant to address more than just the transmission of the flu, there are some provisions that could be related to the provisions of this bill. For example, with regard to "medical services," which the regulation states includes vaccinations, tests, examinations, evaluations, determinations, procedures, and medical management and follow-up, the law requires them to be, among other things, provided in a manner that ensures the confidentiality of employees and patients. g) Other states . On February 15, 2012, the Colorado state Board of Health passed a rule regarding influenza vaccinations for health care workers. The rule requires SB 1318 Page 12 licensed health care facilities to submit data regarding their employee vaccinations to the state Department of Public Health and Environment on an annual basis. Some of the details of the rule are as follows: A facility must meet vaccination rates for each given year to be exempt from the rule. If the facility can meet or exceed the target vaccination percentages listed below for each given year, the facility will be exempt from the rule for the following year as long as it continues to use the same or more stringent methods of promoting or mandating influenza vaccinations for its employees. The targets required for this exemption are as follows: 60% of all employees vaccinated from Oct. 1, 2012, to Dec. 31, 2012. 75% of all employees vaccinated from Oct. 1, 2013, to Dec. 31, 2013. 90% of all employees vaccinated from Oct. 1, 2014, to Dec. 31, 2014, and every year thereafter. A hospital, hospital unit, ambulatory surgical center, or long-term nursing care facility that does not achieve the target vaccination rates of 60%-75%-90% will be required to implement an influenza vaccination policy for that includes a medical exemption. A medical exemption must be signed by a Colorado licensed physician, physician's assistant, advanced practice nurse, or nurse midwife stating the vaccination is medically contraindicated as described in the federal Food and Drug Administration product labeling. This means that the only health care workers who are not required to receive an annual influenza vaccine are those who have a confirmed medical reason that they cannot receive the vaccine because it will be harmful to their health. If a health care worker has a medical exemption, the policy also must require that the health care worker wears a surgical or procedure mask during influenza season (November - March) when in direct contact with patients and in common areas as specified by the facility's policy. 1)SUPPORT . The California Medical Association, the Health Officers Association of California, and the California Primary SB 1318 Page 13 Care Association state that this bill will improve the public health and protect the staff and patients at clinics and health care settings in the most proven effective and efficient way possible. The California Hospital Association states that voluntary immunization programs have failed to increase immunization rates among health care workers to acceptable levels required to substantially reduce health care-acquired flu. Institutions that have implemented a mandatory policy have dramatically reduced employee absenteeism as well as health care associated flu, improving patient safety and reducing health care costs. 2)OPPOSITION . The California Labor Federation (CLF) states that it does not believe that masking is the most effective strategy to achieve the goal of protecting patients from flu transmission. To truly prevent transmission of flu, employers must implement a comprehensive infection control program that includes a range of measures, robust education, and training programs for workers, reasonable access to vaccination, and adequate sick time policies. It opposes the masking of health care workers who decline the vaccine because there is no scientific evidence that wearing surgical masks by unvaccinated workers protects patients. In fact, research shows that masking can lead to more contamination and potential for infection from the frequent mouth, nose, and eye contact necessitated when workers adjust or take off their masks. Masks also interfere with communication between healthcare workers and patients. CLF states they have offered amendments to meet the goal of a 90% vaccination rate in health care facilities without using masking. That proposal includes a set goal of 90% vaccination for all health facilities: phase-in education requirements based on the ATD standards; and, requirements of additional measures to ensure that all health care facilities reach a 90% vaccination rate if they do not achieve that goal by the set date. The California Nurses Association (CNA), also in opposition, states that consumers should know the flu vaccination rates of health care facilities and has suggested amendments to include a public posting that displays vaccination rates in all licensed health facilities. CNA believes that a comprehensive solution to infection control is the best strategy to protect hospitalized Californians, including a broad educational and training program for workers on overall infection control, reasonable access to vaccination, and adequate sick time SB 1318 Page 14 policies. CNA agrees with the concerns raised by the CLF. The American Federation of State, County and Municipal Employee indicates that it is more sensible to work on educating health care workers on better infection control and improving screening and triaging of patients, families, and visitors who enter health care facilities. Hospitals, clinics, and doctors' offices should work to ensure environmental cleaning staff has the training, equipment, and time to do all the cleaning required to clean surfaces routinely, especially around symptomatic patients, which would require facilities to have adequate staffing levels. SEIU California states that it takes issue with any measure which has the effect of coercing people to undergo a medical procedure or risk sanction. There is no demonstrated public health purpose served by the mask itself other than the effect of coercing workers to get the vaccine. SEIU California indicates that this bill should instead fund Cal/OSHA and require health care facilities to fully implement the ATD standards. 3)RELATED LEGISLATION . AB 2009 (Galgiani) allows DPH to provide guidance to local agencies as to whether one or more population groups have priority to receive the flu vaccine under a flu vaccine program administered by DPH for older adults (60 years or older). AB 2009 is pending in the Senate. AB 2064 (V. Manuel Pérez) requires health care service plans and health insurers that provide coverage for childhood and adolescent immunizations to reimburse physicians for the costs of vaccines, as specified. AB 2064 is pending in the Assembly Appropriations Committee. AB 2109 (Pan) specifies certain requirements for parents and guardians of school-aged children who wish to seek an exemption from immunization requirements. AB 2109 is pending in the Senate. 4)PREVIOUS LEGISLATION . SB 739 among other things, requires all California general acute care hospitals, based on CDC guidelines, to: a) Annually offer onsite flu vaccinations, if available, to all hospital employees at no cost to the employee. SB 1318 Page 15 Requires each 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 has declined the vaccination. b) Institute respiratory hygiene and cough etiquette protocols, develop and implement procedures for the isolation of patients with flu, and adopt a program plan for vaccinating healthcare personal during the flu season. c) Revise an existing or develop a new disaster plan that includes a pandemic flu component. The plan must also document any actual or recommended collaboration with local, regional, and state public health agencies or officials in the event of a flu pandemic. REGISTERED SUPPORT / OPPOSITION : Support California Medical Association (cosponsor) California Association for Nurse Practitioner (cosponsor) Health Officers Association of California (cosponsor) American Academy of Pediatrics American Congress of Obstetricians and Gynecologists, District IX California California Academy of Physician Assistants California Hospital Association California Pharmacists Association California Primary Care Association California Psychiatric Association California Society of Health-System Pharmacists County Health Executives Association of California Santa Clara County Board of Supervisors One individual Opposition American Federation of State, County and Municipal Employees, AFL-CIO California Alliance for Retired Americans California Labor Federation California Nurses Association California School Employees Association, AFL-CIO Laborers' Locals 777 & 792 SB 1318 Page 16 SEIU California United Nurses Associations of California/Union of Health Care Professionals Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916) 319-2097