BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | AB 2272| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- 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. AB 2272 Page 2 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 AB 2272 Page 3 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. AB 2272 Page 4 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 AB 2272 Page 5 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 AB 2272 Page 6 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. AB 2272 Page 7 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 AB 2272 Page 8 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 **** END ****