BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: SB 1318 AUTHOR: Wolk AMENDED: April 11, 2012 HEARING DATE: April 18, 2012 CONSULTANT: Moreno SUBJECT : Health facilities: influenza vaccinations. SUMMARY : Requires hospitals and clinics, after July 1, 2013, to require all employees, contractors, students, volunteers, persons with privileges on the medical staff, and all other onsite health care workers affiliated with the clinic to either annually receive an influenza vaccination or, as an alternative to the annual influenza vaccination, wear a surgical or procedural mask, or other mask that covers the mouth and nose area of the face while this person is performing his or her duties in any patient care area of the clinic during the influenza season, as defined by the State Health Officer (SHO) or a local health officer (LHO), or both. Existing law: 1.Provides for the licensure and regulation of health facilities, including acute care hospitals, by the Department of Public Health (DPH). 2.Requires DPH to require that each general acute care hospital, in accordance with the Centers for Disease Control and Prevention (CDC) guidelines, take all of the following actions: a. Annually offer onsite influenza vaccinations, if available, to all hospital employees at no cost to the employee. b. Requires hospitals 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. c. Institute respiratory hygiene and cough etiquette protocols, develop and implement procedures for the isolation of patients with influenza, and adopt a seasonal influenza plan. d. Revise an existing or develop a new disaster plan that includes a pandemic influenza component. The plan is required to document any actual or recommended Continued--- SB 1318 | Page 2 collaboration with local, regional, and state public health agencies or officials in the event of an influenza pandemic. This bill: 1.Requires clinics to annually offer its employees influenza vaccines, if available, at no cost to the employee. 2.Requires hospitals and clinics, after July 1, 2013, to require all employees, contractors, students, volunteers, persons with privileges on the medical staff, as defined, and all other onsite health care workers, as defined, to either annually receive an influenza vaccination or wear a surgical or procedural mask, or other mask that covers the mouth and nose area of the face while this person is performing his or her duties in any patient care area of the clinic during the influenza season, as defined by the SHO or a LHO, or both. 3.Defines "medical staff" as professional medical personnel who are approved and given privileges to provide health care to patients in a clinic and who are responsible for the adequacy and quality of care rendered to patients. States that medical staff includes physicians and surgeons, and, where dental or podiatric services are provided, dentists or podiatrists. Defines "health care worker" affiliated with the facility as 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. Requires a health care worker affiliated with the facility to include, but not be limited to, physicians, nurses, nursing assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, laboratory personnel, autopsy personnel, students and trainees, and contractual staff not employed by the facility. 4.Requires clinics and hospitals to develop policies to ensure its employees, contractors, students, volunteers, and other onsite health care workers affiliated with the clinic, not including medical staff, are in compliance with the vaccination requirements imposed by this bill. Requires medical staff to develop policies independent of the policies established by the facility to ensure that persons who have privileges on the medical staff are in compliance with the vaccination requirements of this bill. 5.Prohibits anything in this bill from being construed to prevent a facility from instituting additional measures to SB 1318 | Page 3 maximize influenza vaccination rates and to prevent health care workers affiliated with the clinic from contracting and transmitting the influenza virus. FISCAL EFFECT : This bill has not been analyzed by a fiscal committee. COMMENTS : 1.Author's statement. According to the author, influenza is a contagious respiratory virus and is the eighth leading cause of death in the United States. The majority of influenza-related illnesses and deaths occur among our most vulnerable that are at a high risk for serious flu complications, such as, infants, young children, seniors and those with certain health conditions. SB 1318 will ensure that all health care workers in health care facilities, including physicians, either receive the influenza vaccination or wear a mask during flu season, in an effort to help prevent the spread of the virus. The U.S. Department of Health and Human Services has a 90 percent vaccination rate goal for health care personnel by 2020. This bill is an essential step toward reaching our national goal and preventing the outbreak of influenza in California's health care facilities and protecting vulnerable patients. 2.Background. 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: children younger than 5, but especially children younger than 2 years old; adults over 65 years of age; pregnant women; and people with certain medical conditions (including asthma, SB 1318 | Page 4 neurological and neurodevelopmental conditions, chronic lung disease, heart disease, blood disorders, diabetes, kidney disorders, liver disorders, and weakened immune systems). 3.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 influenza 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 also recommend that all health care workers get vaccinated annually against influenza. 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 percent in 2008-09 and has grown since: 63 percent in 2009-10 and 64.3 percent in 2010-11. The U.S. Department of Health and Human Services' goal is a 90 percent vaccination rate by 2020. 4.Previous statewide efforts. Upon passage of SB 739 (Speier), Chapter 526, Statutes of 2006, DPH's Healthcare Associated Infections (HAI) Program was tasked with increasing patient protection from influenza in hospitals through vaccination of healthcare personnel. The Department of Industrial Relation's Division of Occupational Safety and Health (Cal/OSHA) also promulgated (aerosol transmissible diseases) ATD regulations (effective August 5, 2009), establishing procedures for ATD in health care facilities. Among other things, the ATD regulations require health facilities to establish, implement, and maintain an effective, written ATD Exposure Control Plan SB 1318 | Page 5 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. 5.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 Epidemiology, the Infectious Diseases Society of America, and the National Business Group on Health. 6.Existing masking policies. Currently, Sacramento, San Francisco, and Yolo counties have in effect similar masking policies to the one proposed in 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 influenza 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 requiring that all healthcare workers either receive the influenza vaccine or wear a mask during influenza season. All SB 1318 | Page 6 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 influenza 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 influenza 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 out, 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 an "influenza 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 will be removed from working in patient care areas. 7.Use of masks in preventing spread of the flu. There is some question about the value of surgical masks protection against the flu, and several studies point to differing outcomes. For example, a 2009 study published in JAMA found that surgical masks appear to be nearly as effective as N95 respirators (which the CDC recommends for the protection of health care workers who come in direct contact with patients with H1N1) at preventing flu in health care workers performing routine care. On the other hand, a 2008 CDC study in the journal Emerging Infectious Diseases concluded that health care workers could contaminate their skin or clothes with pathogens during the removal of personal protection equipment (such as surgical masks), resulting in accidental self-inoculation and virus spread to patients and other health care workers. SB 1318 | Page 7 8.Related legislation. AB 2009 (Galgiani) would include persons under 18 years of age among those who have priority to receive flu vaccine under a flu vaccine program administered by DPH for older adults (60 years or older). AB 2009 passed by a vote of 18-0 when heard in the Assembly Health Committee on April 10, 2012. AB 2064 (V. Manuel Pérez) would require 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 set to be heard in the Assembly Health Committee on April 24, 2012 AB 2109 (Pan) would specify certain requirements for parents and guardians of school-aged children who wish to seek an exemption from immunization requirements. AB 2109 is set to be heard in the Assembly Health Committee on April 17, 2012 9.Prior legislation. SB 739 among other things, requires all California general acute care hospitals, based on CDC guidelines, to: a. Annually offer onsite influenza vaccinations, if available, to all hospital employees at no cost to the employee. Each general acute care hospital shall 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 influenza, and adopt a program plan for vaccinating healthcare personal during the influenza season. c. Revise an existing or develop a new disaster plan that includes a pandemic influenza 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 an influenza pandemic. 10.Support. The California Medical Association (CMA), co-sponsor of this bill, argues that masking policies have proven to be the most effective policy to increase vaccination compliance rates and protect its patients. CMA states that California hospitals with the highest vaccine compliance rate are those that have such policies in place. CMA asserts that SB 1318 | Page 8 the sole purpose of this bill is to protect patients from contracting the flu virus in health care settings and do it in the most proven effective and efficient way possible. The Health Officers Association of California (HOAC), co-sponsor of this bill, states that this bill will increase influenza vaccination rates at hospitals in California, resulting in a healthier workforce and a healthier population. According to The American Congress of Obstetricians and Gynecologists, District IX (California), SB 739 required California's acute care hospitals to offer the vaccine free of charge, but unfortunately the success of that legislation has fallen short of achieving desired compliance rates, and we need to look at other options to protect our most vulnerable populations. The California Association for Nurse Practitioners (CANP), co-sponsor of this bill, writes that several counties and numerous hospitals have gone beyond state law and have established mandatory vaccination policies. CANP states that according to their members, receiving an annual flu vaccine has become a standard practice for health care providers, and this bill will ensure that this practice becomes even more firmly entrenched as a practice. The California Pharmacists Association (CPA) states that reports have shown that higher vaccination levels among staff have been associated with a lower risk of hospital-acquired influenza cases, while lower influenza vaccination coverage has led to a greater number of influenza outbreaks in hospitals and long-term care facilities. CPA asserts that strict vaccination policies that include a masking requirement for those who decline vaccinations have proven to be the most effective way of increasing vaccination rates and protecting patients. The California Psychiatric Association writes that many of the circumstances which bring individuals to these facilities, such as protracted homelessness, present decreased immune response to viruses and increased risks of contraction of infectious disease, and that it is imperative that simple measures of vector control, such as vaccinations or masks, be provided to facility staff. The California Society of Health-System Pharmacists states that influenza is a contagious respiratory disease and without proper prevention and vaccination, the general public is placed at undue risk. 11.Opposition. The American Federation of State, County and Municipal Employees, AFL-CIO (AFSCME) and the United Nurses Associations of California/Union Health Care Professionals (UNAC/UHCP) write that it is unreasonable to mandate a SB 1318 | Page 9 questionably effective vaccine on onsite health care workers and that it is more sensible to work on educating workers on better infection control and improve screening and triaging of patients, families, and visitors who enter health care facilities. AFSCME and UNAC/UHCP state that that hospitals, clinics, doctors' offices should work to ensure environmental cleaning staff have the training, equipment, and time (adequate staffing levels) to do all the cleaning required to clean surfaces routinely, especially around symptomatic patients. The California Nurses Association (CNA) writes that this bill provides for the medical staff at health facilities and clinics to develop an independent influenza policy, and that having two separate influenza policies for employees who work in the same clinics and health facilities is confusing for those attempting to implement the new policy, and in particular for the employees who are navigating through two separate policies. CNA also asserts that transmission of the influenza virus does not delineate between classifications of health care workers and that having two policies jeopardizes patients, workers and the public who enter the health facilities and clinics. CNA states that there is no sound public policy that supports two standards, and they strongly object, stating it is divisive and could lead to future discrimination issues in the workplace. CNA further states that requiring health care workers who decline vaccination to wear a mask will not properly stem the transmission of influenza. CNA points to a 2008 CDC study that concludes that although personal protection equipment is usually worn only a short time, viruses such as influenza can survive for hours on surfaces, and viral infection can be spread by surface-to-hand and hand-to-hand contact by adjusting or removing the mask, and that masking creates a false sense of protection for employees and patients. Laborers' Locals 777 and 792 writes that current data do not dictate that everyone who works in a health facility should get a flu shot, there are reasons an employee may be disinclined to get a flu shot, and they should not be forced to wear the "Scarlett Letter" of a mask just because they've chosen not to get a flu shot. 12.Oppose unless amended. The Service Employees International Union (SEIU) writes that they are highly supportive of educating the public, particularly workers in health facilities, about the importance of all disease prevention SB 1318 | Page 10 including those measures designed to prevent transmission of flu virus. SEIU applauds expanding the current law to all health facilities and states that to the extent that we can prevent the transmission of flu virus, it makes no sense to limit our protections to acute care hospitals when there are very vulnerable patients in so many other health care settings. SEIU takes issue with any measures which have the effect of coercing people to undergo a medical procedure (in this case vaccination) or risk sanction. SEIU states that this is precisely the effect that both the sponsor and author say they intend by requiring employees to wear a mask, and there is no public health purpose served by the mask itself other than the effect of coercing workers to get the vaccine. Further, SEIU contends that one of the many reasons that no other state in the nation requires health care workers to get these vaccines or face disciplinary proceedings and wearing masks is because it may be unconstitutional to do so, and when this is coupled with a mandate for wearing masks (unsupported by compelling scientific evidence), the risk is having this law overturned by the courts. SUPPORT AND OPPOSITION : Support: California Association for Nurse Practitioners (co-sponsor) California Medical Association (co-sponsor) Health Officers Association of California (co-sponsor) American Congress of Obstetricians and Gynecologists - District IX California California Association for Nurse Practitioners California Pharmacists Association California Psychiatric Association California Society of Health-System Pharmacists Californians for Patient Care Santa Clara County Board of Supervisors Oppose:American Federation of State, County and Municipal Employees, AFL-CIO California Labor Federation California Nurses Association Laborers' Locals 777 and 792 Service Employees International Union (unless amended) United Nurses Associations of California/Union of Health Care Professionals -- END -- SB 1318 | Page 11