BILL ANALYSIS                                                                                                                                                                                                    






                             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---



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               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 




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            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, 




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            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 




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            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 




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               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.




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          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 Prez) 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 




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            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 




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            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 




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            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 --
          




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