BILL ANALYSIS                                                                                                                                                                                                    �






                 Senate Committee on Labor and Industrial Relations
                                 Ted W. Lieu, Chair

          Date of Hearing: April 25, 2012              2011-2012 Regular 
          Session                              
          Consultant: Gideon L. Baum                   Fiscal:Yes
                                                       Urgency: No
          
                                  Bill No: SB 1318
                                    Author: Wolk
                        As Introduced/Amended: April 17, 2012
          

                                       SUBJECT
          
                     Health facilities: influenza vaccinations.


                                      KEY ISSUE

          Should the Legislature require that all employees, contractors, 
          students, volunteers, persons with privileges on the medical 
          staff, and all other onsite health care workers at health 
          facilities and clinics be vaccinated against influenza or wear a 
          facemask?
          

                                       PURPOSE
          
          To repeal the existing process for employees of general acute 
          care hospitals to decline the influenza vaccination and create 
          new influenza vaccination requirements for workers employed by 
          and affiliated with health facilities and clinics.


                                      ANALYSIS
          
           Existing law  provides for the Occupational Safety and Health 
          Standards Board (OSHSB), which consists of seven individuals 
          appointed by the Governor for four year terms.  Two members must 
          be from the field of management, two members must be from the 
          field of labor, one member must be from the field of 
          occupational health, one member must be from the field of 
          occupational safety and one member must be from the general 
          public (Labor Code ��140 and 141).










           Existing law  empowers OSHSB, by an affirmative vote of four or 
          more members, to adopt, amend, or repeal occupational safety and 
          health standards.  The procedure to adopt, repeal, or amend 
          occupational safety and health standards must follow the process 
          for promulgating regulations, unless otherwise stated in Labor 
          Code (Labor Code ��142.3 and 142.4).

           Existing law  requires that the Department of Occupational Safety 
          and Health (DOSH) enforce all occupational safety and health 
          standards adopted by OSHSB (Labor Code �142).

           Existing law  requires that OSHSB develop or revise certain 
          specific occupational safety and health standards, including 
          bloodborne pathogens, hazardous substance removal work, 
          agricultural field sanitation, and lead-related construction.  
          (Labor Code ��142.7, 144.7, 6712, & 6717)
           
          Existing OSHA Regulations  create an occupational safety standard 
          requiring certain protections for workers who may be exposed to 
          an Aerosol Transmissible Disease (ATD).  The ATD standard is not 
          for seasonal influenza, although it would cover new variants of 
          influenza (swine and bird flu, for example).  
          (California Code of Regulations, Title 8, �5199)
           
          Existing law  requires that each general acute care hospital, in 
          accordance with the Centers for
          Disease Control guidelines, take all of the following actions:

             a)   Annually offer onsite influenza vaccinations 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 seasonal 
               influenza plan;
             c)   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 
          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 2

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               officials in the event of an influenza pandemic.

          (Health and Safety Code �1288.7)

           Existing law  defines a "health facility" as any facility, place, 
          or building 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.  This 
          includes general acute care hospitals.  (Health and Safety Code 
          �1250)

           Existing law  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.  
          (Health and Safety Code �1200)

           This bill  would repeal, as of July 1, 2013, existing requirement 
          covering general acute care hospitals and would instead 
          institute, as of July 1, 2013, the following:

             a)   Requires all health facilities to annually offer its 
               employees onsite influenza vaccinations, if available, at 
               no cost to the employee;

             b)   Repeals the ability of an employee to decline 
               vaccination through a written declaration; 

             c)   Requires that, if an employee declines an immunization, 
               the employee must use a health facility-provided 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 health 
               facility during the influenza season, as defined by the 
               State Health Officer or a local health officer, or both;

             d)   Extends the vaccination or masking requirements to all 
          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 3

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               contractors, students, volunteers, persons with privileges 
               on the medical staff, and all other onsite health care 
               workers affiliated with the health facility; 

             e)   Requires the health facility to maintain influenza 
               vaccination records of employees, contractors, students, 
               volunteers, persons with privileges on the medical staff, 
               and all other onsite health care workers affiliated with 
               the health facilities who were vaccinated onsite or 
               offsite.  If the health facility does not have records of a 
               worker being vaccinated onsite, the health facility must 
               require that the worker either provides documentation of an 
               offsite vaccination or documentation that he or she refused 
               the vaccination;

             f)   Requires each health facility to develop policies to 
               ensure its employees, contractors, students, volunteers, 
               and other onsite health care workers affiliated with the 
               health facility,  not including medical staff  , are in 
               compliance with the vaccination requirements imposed by 
               this section. 

             g)   Requires the medical staff to develop policies 
               independent of the policies established by the health 
               facility to ensure that persons who have privileges on the 
               medical staff are in compliance with the vaccination 
               requirements of this section.

             h)   Specifies that nothing in this section shall be 
               construed to prevent a health facility from instituting 
               additional measures to maximize influenza vaccination rates 
               and to prevent health care workers affiliated with the 
               health facility from contracting and transmitting the 
               influenza virus;

             i)   Continues the requirement on general acute care 
               hospitals to take all of the following actions:

                  i.        Institute respiratory hygiene and cough 
                    etiquette protocols, develop and implement procedures 
                    for the isolation of patients with influenza, and 
                    adopt a seasonal influenza plan; and
          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 4

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                  ii.       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.

             a)   Defines "Health care worker affiliated with the health 
               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 health facility.  This 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, and contractual staff not employed by the health 
               facility.

             b)   Defines "Medical staff" as 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 physicians, and, where 
               dental or podiatric services are provided, dentists or 
               podiatrists.

           This bill  would also extend the requirements listed above to 
          clinics.


                                      COMMENTS

          
          1.  A Brief Discussion on the Influenza Virus and Vaccine:  
           
            According to the Centers for Disease Control and Prevention 
            (CDC), the influenza virus, also known as the flu, is a 
            contagious respiratory illness 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, 
          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 5

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            sneeze or talk. These droplets 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.

            There are two types of flu vaccines: the traditional "Flu 
            shot", which is the inactivated vaccines (containing killed 
            virus) that are given with a needle, and the nasal-spray flu 
            vaccine, which is a vaccine made with live, weakened flu 
            viruses that is given as a nasal spray.  As will be discussed 
            below, both vaccines have certain restrictions. 

            Since 2010, the CDC has recommended that everyone over six 
            months of age should get a flu immunization, including 
            healthcare workers.  However, certain individuals should not 
            get the flu vaccine for health reasons.  They include 
            individuals who are allergic to eggs or have other severe 
            allergies, individuals who have had Guillain-Barr� Syndrome, 
            and anyone currently suffering from fever or illness.  
            Additionally, certain individuals should only get the 
            inactivated vaccine, including adults over 50 years of age, 
            pregnant women, and anyone with certain muscle disorders.

          2.  What are the CDC Recommendations for Seasonal Influenza in the 
            Healthcare Setting?
           
            The current law flu vaccine requirements are based on CDC 
            recommendations on how to control the spread of influenza in 
            the healthcare setting.  The most recent recommendations focus 
            on promoting influenza vaccination for all healthcare 
            personnel (HCP), which includes nurses physicians, and those 
            not directly involved with patient care but could spread the 
            flu.  As part of a systemic strategy to combat the flu, the 
            CDC suggests providing the vaccine at no cost, requiring 
            personnel to sign declination forms to acknowledge that they 
            have been educated about the benefits and risks of 
            vaccination, as well as simply mandating the flu vaccine.

            The CDC also provides facemask recommendations.  Several of 
            the recommendations cover ill patients or ill HCP.  Outside of 
            those examples, the guidelines suggest the use of a facemask 
          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 6

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            upon entering the room of a patient and discarding the mask 
            immediately upon leaving the room.  In the event that the 
            employee has opted out, the guidelines suggest to not use a 
            facemask, but rather "to provide employees with alternative 
            personal protective equipment, this equipment should provide 
            the same protection of the nose and mouth from splashes and 
            sprays provided by facemasks (e.g., face shields and N95 
            respirators or powered air purifying respirators)."

            Finally, the CDC also makes suggestions on sick leave policies 
            for healthcare personnel.  Specifically, the CDC suggests that 
            healthcare employers develop "sick leave policies for HCP that 
            are non-punitive, flexible and consistent with public health 
            guidance to allow and encourage HCP with suspected or 
            confirmed influenza to stay home."  The CDC also suggests 
            temporary reassignment for healthcare personnel who come back 
            from sick leave due to the flu.

          3.  Face Mask Efficacy and Influenza:  

            From the Senate Health Committee Analysis:

            "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."

          4.  Possible Amendments:  

            As currently written, SB 1318 would pose some unique issues 
            from the perspective of California Labor Law that the 
            Committee may wish to consider.  Specifically:
          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 7

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             Required Vaccinations and Workers' Compensation:  

            As has already been discussed, students and volunteers are 
            included in the requirement of being vaccinated against 
            influenza.  However, as they do not have an employment 
            relationship with either the hospital or a related vendor, 
            they would not be covered by the workers' compensation system. 
             As such, in the event of an adverse reaction to the influenza 
            vaccination, they would be required to pay for their own 
            healthcare.  The Committee may wish to consider if such an 
            outcome is appropriate.

             Employment-Related Vaccinations and Their Provision:  

            SB 1318 currently provides that both health facilities and 
            clinics must make the influenza vaccine available to their 
            employees at no cost.  However, the bill does not extend a 
            similar requirement to contractors, students, volunteers, 
            persons with privileges on the medical staff, and all other 
            onsite health care workers.  This creates an 
            employment-specific requirement to these individuals, but 
            requires that they fulfill that requirement using their own 
            resources.  The Committee may wish to consider if such an 
            outcome is appropriate.

             Differing Vaccination Requirements between Physicians and 
            non-Physicians:  

            As was discussed above, SB 1318 requires the creation of a 
            different vaccine compliance policy for physicians and 
            specialists.  It is unclear how creating dueling compliance 
            policies would further the goal of increased influenza 
            vaccination.  While the health facility and clinic may only 
            have a contractual relationship with Medical Staff, these 
            individuals are offering direct patient treatment and could 
            spread influenza to patients.  The Committee may wish to 
            consider if separate compliance programs are efficacious.

             The Goal of Mandatory Facemasks:  

            As was discussed above, the CDC unambiguously suggests 
          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 8

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            influenza vaccines for nearly all healthcare personnel.  
            However, the use of facemasks in lieu of influenza vaccines 
            may be problematic; if the 2008 CDC study is correct, it may 
            perversely make healthcare personnel more likely to come down 
            with the flu.  Additionally, mandatory masking may be viewed 
            by some employees as a tool to push towards vaccination due to 
            the discomfort of wearing the mask on a regular basis.  

            Rather than eliminating the existing declaration process, it 
            may be worthwhile to instead focus on educating employees and 
            others on the efficacy of the influenza vaccine and its low 
            level of adverse side effects.  As was discussed in the recent 
            National Vaccine Advisory Committee report, most HCP declined 
            the influenza vaccine due to fear of an adverse reaction.  The 
            Committee may wish to consider if eliminating the vaccine 
            declaration is efficacious.

             Noting the above mentioned issues, as well as the need to 
            protect patients from the influenza virus, the Committee may 
            wish to consider the following amendments, which would:
           
               a)     Keep the expansion of the vaccination requirement to 
                 all health facilities and clinics as well as the same 
                 groups of healthcare professionals; 
               b)     Remove students and volunteers to avoid workers' 
                 compensation issues;
               c)     Combines vaccination compliance programs and 
                 clarifies who pays for the vaccinations; and 
               d)     Retains the existing declaration structure in the 
                 event a healthcare professional does not wish to be 
                 vaccinated.
            
             1)   On page 3, strike lines 23 to 40; 

             2)   On page 4, strike lines 1 to 36; 

             3)   On page 4, line 39 strike "By July 1, 2007, the" and 
               insert "The";

             4)   On page 4, line 40, strike "general acute care 
               hospital," and insert "clinic and health facility";

          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 9

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             5)   On page 5, line 4, strike "hospital" and insert 
               "contractors, persons with privileges on the medical staff, 
               and all other onsite health care workers affiliated with 
               the clinic or health facility" after "employees,";

             6)   On page 5, line 4, strike "to the employee";

             7)   On page 5, lines 4 and 5, strike "general acute care 
               hospital" and insert "clinic and health facility";

             8)   On page 5, line 5, insert ", contractors, persons with 
               privileges on the medical staff, and all other onsite 
               health care workers affiliated with the clinic or health 
               facility" after "employees";

             9)   On page 5, line 6, insert ", contractor, person with 
               privileges on the medical staff, or onsite health care 
               worker affiliated with the clinic or health facility" after 
               "employee";

             10)  On page 5, between lines 15 and 16, insert the 
               following:

               (d) For purposes of this section, the following definitions 
               shall apply:

               (1) "Health care worker affiliated with the clinic or 
               health facility" means a person who is employed by, paid 
               by, or receives credit or any other form of compensation 
               from the clinic or health facility. Health care worker 
               affiliated with the clinic includes, but is not limited to, 
               physicians, nurses, nursing assistants, therapists, 
               technicians, emergency medical service personnel, dental 
               personnel, pharmacists, laboratory personnel, autopsy 
               personnel, and contractual staff.

               (2) "Medical staff" means professional medical personnel 
               who are approved and given privileges to provide health 
               care to patients in a clinic or health facility and who are 
               responsible for the adequacy and quality of care rendered 
               to patients. Medical staff includes physicians and 
               surgeons, and, where dental or podiatric services are 
          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 10

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               provided, dentists or podiatrists.

             11)  On page 5, strike lines 16 to 40;

             12)  On page 6, strike lines 1 to 40;

             13)  On page 7, strike lines 1 to 4.



          5.  Proponent Arguments  :
            
            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 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.  

          6.  Opponent Arguments  :
          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 11

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            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 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. 



          7.  Prior Legislation  :

            SB 739 (Speier), Chapter 526, Statutes of 2006, creates the 
            existing influenza vaccination structure for general acute 
            care hospitals.


                                       SUPPORT
          
          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 12

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          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
          

                                     OPPOSITION
          
          American Federation of State, County and Municipal Employees, 
            AFL-CIO
          California Labor Federation, AFL-CIO
          California Nurses Association
          Laborers' Locals 777 and 792
          Service Employees International Union (unless amended)
          United Nurses Associations of California/Union of Health Care 
            Professionals


















          Hearing Date:  April 25, 2012                            SB 1318  
          Consultant: Gideon L. Baum                               Page 13

          Senate Committee on Labor and Industrial Relations