BILL ANALYSIS                                                                                                                                                                                                    Ó






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          |SENATE RULES COMMITTEE            |                       AB 2272|
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                                   THIRD READING 


          Bill No:  AB 2272
          Author:   Thurmond (D) 
          Amended:  8/15/16 in Senate
          Vote:     21 

           SENATE LABOR & IND. REL. COMMITTEE:  4-1, 6/22/16
           AYES:  Mendoza, Jackson, Leno, Mitchell
           NOES:  Stone

           SENATE APPROPRIATIONS COMMITTEE:  5-2, 8/11/16
           AYES:  Lara, Beall, Hill, McGuire, Mendoza
           NOES:  Bates, Nielsen

           ASSEMBLY FLOOR:  49-23, 5/19/16 - See last page for vote

           SUBJECT:   Occupational safety and health standards:  plume


          SOURCE:    California Nurses Association/National Nurses United


          DIGEST:  This bill requires the Division of Occupational Safety  
          and Health to convene an advisory committee to develop a  
          regulation regarding the protection of health care personnel and  
          patients from exposure to vaporized human tissue, defined in  
          this bill as "plume." Requires the regulation include a  
          requirement for employers to provide training to employees that  
          may be exposed to plume on its nature, risk, and methods to  
          avoid exposure. Requires the proposed regulation be submitted to  
          the Occupational Safety and Health Standards Board for  
          consideration and subsequent adoption by July 1, 2019. 










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          ANALYSIS:


          Existing law:


          1)Establishes the Occupational Safety and Health Standards Board  
            (Board), within the Department of Industrial Relations, as the  
            standards-setting agency for the Division of Occupational  
            Safety and Health (Cal/OSHA). The Board promulgates and  
            enforces occupational safety and health standards for the  
            state including standards dealing with toxic materials and  
            harmful physical agents (Labor Code §140, §142.3, and §144.6).


          2)Stipulates that in promulgating standards dealing with toxic  
            materials or harmful physical agents, the Board shall adopt  
            standards to prevent employees from suffering adverse health  
            effects even if these employees have regular exposure to a  
            regulated hazard (Labor Code §144.6).


           This bill: 


          1)Requires Cal/OSHA, by June 1, 2017 to form an advisory  
            committee to develop and submit to the Board by June 1, 2018,  
            a regulation to protect health care personnel and patients  
            from plume (see below) exposure through the use of plume  
            scavenging systems. This will be accomplished by requiring  
            health facilities to use these plume scavenging systems in all  
            settings that could create plume.


          2)Defines "plume" as vaporized human tissue or noxious airborne  
            contaminants generated as byproducts of the use of  
            energy-based devices, electrosurgical devices, electrocautery  
            devices, or mechanical tools during surgical, diagnostic, or  
            therapeutic procedures. These plume-generating devices are  
            also defined.


          3)Defines "plume scavenging systems" as devices including smoke  
            evacuators, laser plume evacuators, plume scavengers, and  







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            local exhaust ventilators that capture and neutralize plume at  
            the site of origin and before plume can make ocular contact or  
            contact with the respiratory tract of employees.


          4)Allows the Cal/OSHA advisory committee to include health  
            facilities, practicing physicians and surgeons from affected  
            specialties, registered nurses and other affected health care  
            personnel, labor and specialty organizations representing  
            affected registered nurses and health care personnel, and  
            other stakeholders. 


          5)Mandates that in developing this regulation, the Cal/OSHA  
            advisory committee consider, and evaluate as a benchmark,  
            preexisting plume-related standards including those adopted at  
            the federal Occupational Safety and Health Administration and  
            the National Institute for Occupational Safety and Health, as  
            well as other private groups such as the International  
            Organization for Standardization. 


          6)Creates a plume, and plume exposure prevention training  
            requirement, including the use of plume scavenging equipment  
            and systems utilized by health facilities, to be provided by  
            employers for all workers who may encounter plume.


          7)Requires that by July 1, 2019, the Board must adopt the  
            proposed regulation. 


          8)States that its provisions do not alter or affect general room  
            ventilation standards in any way.


          9)Stipulates that the use of surgical masks do not qualify as  
            protection against plume. 


          10)States that the use of respirators does not qualify as  
             protection against plume except when, due to medical  
             necessity, a plume scavenging system is not able to be  
             located where it captures plume effectively.







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          11)Specifies that the regulation shall not limit the authority  
             of Cal/OSHA or the Board to develop or adopt regulations that  
             are broader in scope or application than those set down in  
             the bill.  


          Comments


          Background on Plume - The heat-generated (thermal) destruction  
          of human tissue via cutting during therapeutic removal and  
          burning (cauterization) is commonplace in a wide range of  
          medical procedures.  When human tissue is destroyed in this way,  
          a smoke byproduct or "plume" is created. The plume can contain  
          toxic gases and vapors such as benzene, hydrogen cyanide, and  
          formaldehyde, biological aerosols (a suspension of living  
          bacteria, viral particles or fungal spores), and viruses and  
          blood fragments containing blood-borne pathogens, including  
          multi-resistant strains.  Surgical plume is also known to  
          contain mutagenic (cancer producing) particles. At high  
          concentrations, plume can also cause ocular and upper  
          respiratory tract irritation in health care personnel.  


          Sources to Be Considered in Developing a Plume Regulation - This  
          bill specifies that in developing the plume regulation, the  
          Cal/OSHA advisory committee must consider the benchmarks  
          developed or adopted by the International Organization for  
          Standardization, the CSA Group, the federal Occupational Safety  
          and Health Administration (OSHA) and the National Institute for  
          Occupational Safety and Health (NIOSH). As such, a brief  
          description of these entities follows below.  


           The International Organization for Standardization and CSA are  
          independent, non-governmental organizations that give  
          specifications for products, services and systems in the health  
          care industry among others, to ensure quality, safety and  
          efficiency. Both have developed standards for equipment designed  
          to evacuate plume generated by medical devices. They offer  
          guidance on the purchasing, installation, testing, use,  
          servicing and regular maintenance of systems that collect and  







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          filter plume. 


          NIOSH is a part of the Centers for Disease Control that conducts  
          research and makes recommendations for the prevention of  
          work-related illnesses and injuries. NIOSH has conducted  
          research that suggests airborne contaminants generated by these  
          surgical devices can be effectively controlled through  
          ventilation and specific work practices. NIOSH's recommended  
          ventilation techniques include a combination of general room and  
          local or portable exhaust ventilation.  In terms of work  
          practices, health care personnel would follow established  
          procedures and protocols when using these systems.  Personnel  
          would also use control measures or precautions required by the  
          OSHA Blood-Borne Pathogen standard.


          Currently OSHA has no specific standards for plume hazards,  
          however they make recommendations that could aid in minimizing  
          plume exposure. They include the use of smoke evacuators and the  
          observance of the precautions mentioned above which include the  
          appropriate disposal of all tubing, filters, and absorbers used  
          during smoke-generating surgical procedures, like those involved  
          in the creation of plume. 


          Need for this bill? The author believes that by adopting  
          regulations to remove plume before it is dispersed into a  
          surgical suite and surrounding areas, California could be a  
          leader in the reduction of surgical site infections.  The author  
          contends that this bill is consistent with the Legislature's  
          occupational protection of health care workers in a number of  
          areas including occupational exposure to blood-borne pathogens.  
          The author states that the privately-run Joint Commission on  
          Accreditation of Healthcare Organizations and the federal NIOSH  
          have called for the reduction of plume exposure to health care  
          workers and yet neither a state nor a federal legislative  
          mandate exists.  In developing a standard for California, the  
          author believes that the state can limit the exposure of health  
          care personnel to the pathogenic bacteria and live viruses that  
          plume can contain.


          FISCAL EFFECT:   Appropriation:    No          Fiscal  







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          Com.:YesLocal:   Yes


          According to the Senate Appropriations Committee, the Department  
          of Industrial Relations indicates that costs associated with the  
          Occupational Safety and Health Standards Board's development of  
          standards requiring a health facility to evacuate or remove  
          plume, as specified, would be within the scope of existing  
          workload, and thus absorbable. However, DIR's Division of  
          Occupational Safety and Health would incur unknown enforcement  
          costs once the standards have been developed. 




          SUPPORT:   (Verified6/22/16)


          California Nurses Association/National Nurses United (source)
          American Lung Association in California
          California Labor Federation, AFL-CIO
          Service Employees International Union
          The International Council on Surgical Plume


          OPPOSITION:   (Verified6/22/16)


          California Hospital Association
          California Association of Health Facilities 


          ARGUMENTS IN SUPPORT: Proponents state that surgical plume  
          contains carbon, cellular debris, viral particulates, toxic  
          gases such as carbon monoxide and benzene, and a number of  
          carcinogenic and mutagenic substances. They also state that  
          plume affects any person entering or working in the enclosed  
          space of an operating room where these procedures are occurring.  
          Health care workers who are exposed, often complain of burning,  
          watery eyes, coughing, sore throat, asthma, allergy reactions,  
          nausea, headaches, as well as more serious long-term health  
          problems. 









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          Furthermore proponents argue that, aside from their personal  
          health hazards, if doctors and nurses are affected with these  
          symptoms, they cannot care for patients in the operating room  
          during their most vulnerable times. They state that a broad  
          range of plume scavenging devices is available that are simple  
          to obtain and use. They state that these plume scavenging  
          devices yield great health benefits to everyone in the operating  
          room. While there are a number of standards, guidelines, and  
          recommended professional practices currently published relating  
          to plume, proponents contend that they fail to have a meaningful  
          impact on practice because these standards are not mandated by  
          law. Accordingly, proponents believe that this bill is necessary  
          to develop and codify these health and safety standards.    


          ARGUMENTS IN OPPOSITION:     The California Hospital Association  
          states that surgical plume is recognized to be a complex mixture  
          of particulates, gases, and vapors. CHA has been unable to  
          identify the source of the 95 percent benchmark required by the  
          bill for capturing and neutralizing plume,  and are unclear as  
          to which of the plume components this 95 percent benchmark would  
          apply. CHA is also unclear as to how a hospital would  
          demonstrate achievement of any numeric benchmark. CHA is also  
          concerned that directing Cal/OSHA to utilize specific guidance  
          is too prescriptive, particularly where the guidance referenced  
          is from a non-traditional source. Also CHA believes that the  
          bill is too broad in that it does not distinguish between  
          procedures where plume may be generated in a cavity, and thus  
          there is minimal if any exposure, and where it is generated in  
          the open. 


          CHA also states that the equipment at issue in this bill  
          directly implicates patient care decisions. The hospital's  
          ability to impact decisions made by physicians in the operating  
          room may be limited and could interfere with patient care.  
          Finally, CHA believes that the punitive approach taken by this  
          bill conflicts with the national trend in health care to improve  
          safety through a "just culture" approach.  A collaborative and  
          educational approach is more consistent with the trend to  
          support a blame-free "just culture" environment where employees  
          are encouraged to raise patient and employee safety concerns.

          ASSEMBLY FLOOR:  49-23, 5/19/16







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          AYES:  Alejo, Arambula, Atkins, Bloom, Bonilla, Bonta, Brown,  
            Burke, Calderon, Campos, Chau, Chiu, Chu, Cooley, Cooper,  
            Dababneh, Dodd, Eggman, Frazier, Cristina Garcia, Eduardo  
            Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Roger  
            Hernández, Holden, Irwin, Jones-Sawyer, Levine, Lopez, Low,  
            Medina, Mullin, Nazarian, O'Donnell, Quirk, Ridley-Thomas,  
            Rodriguez, Salas, Santiago, Mark Stone, Thurmond, Ting, Weber,  
            Wood, Rendon
          NOES:  Achadjian, Travis Allen, Baker, Bigelow, Brough, Chávez,  
            Dahle, Beth Gaines, Gallagher, Grove, Harper, Jones, Kim,  
            Lackey, Maienschein, Mayes, Melendez, Obernolte, Olsen,  
            Patterson, Steinorth, Wagner, Wilk
          NO VOTE RECORDED:  Chang, Daly, Hadley, Linder, Mathis, McCarty,  
            Waldron, Williams

          Prepared by:Brandon Seto / L. & I.R. / (916) 651-1556
          8/15/16 19:39:46


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