Under existing law, the Occupational Safety and Health Standards Board within the Department of Industrial Relations promulgates and enforces occupational safety and health standards for the state, including standards dealing with toxic materials and harmful physical agents. Under existing law, the Division of Occupational Safety and Health is required to enforce all occupational safety and health standards, as specified. A violation of these standards and regulations under specific circumstances is a crime.

This bill would, by June 1, 2017, require the division to convene an advisory committee to develop a regulation that requires a health facility to evacuate or remove plume through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume and would authorize certain entities and people to be on the advisory committee, including, among others, practicing physicians and surgeons from affected specialties. The bill would require the division, in developing the regulation to do certain things, including evaluating the use of certain standards adopted by specified organizations as a benchmark. The bill would also require the division, when developing the proposed regulation, to take into consideration recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration or National Institute for Occupational Safety and Health. The bill would, by June 1, 2018, require the division to submit to the board the proposed regulation. The bill would, by July 1, 2019, require the board to adopt the proposed regulation.

The bill would provide that compliance with general room ventilation standards or the use of surgical masks does not satisfy the requirements for protection from surgical plumes under these provisions. The bill would provide that the use of respirators does not satisfy the requirements for protection from surgical plumes under these provisions, except as specified. The bill would require the manufacturer of a plume scavenging system to provide evidence that the system meets specified minimum requirements when installed, operated, and maintained in accordance with the manufacturers instructions.

The bill would specify that these provisions do not limit the authority of the division to develop, or limit the authority of the board to adopt, a regulation with a broader scope or broader application than required by these provisions.

By expanding the definition of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Under existing law, the Occupational Safety and Health Standards Board within the Department of Industrial Relations promulgates and enforces occupational safety and health standards for the state, including standards dealing with toxic materials and harmful physical agents. Under existing law, the Division of Occupational Safety and Health is required to enforce all occupational safety and health standards, as specified. A violation of these standards and regulations under specific circumstances is a crime.

This bill would require the board, by June 1, 2018, to adopt standards to protect health care personnel and patients from plume, defined as noxious airborne contaminants generated as byproducts of the use of specific devices during surgical, diagnostic, or therapeutic procedures. would, by June 1, 2017, require the division to convene an advisory committee to develop a regulation that requires a health facility to evacuate or remove plume through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume and would authorize certain entities and people to be on the advisory committee, including, among others, practicing physicians and surgeons from affected specialties. The bill would require the board, division, in adopting these standards, developing the regulation to take into consideration and use as a benchmark do certain things, including evaluating the use of certain standards adopted by specified organizations. organizations as a benchmark. The bill would also require the board to use as the mandated requirement for plume scavenging systems recommendations of division, when developing the proposed regulation, to take into consideration recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration or National Institute for Occupational Safety and Health, where the board determines those recommendations are more effective in the evacuation of plume and would be more protective of occupational health than the described standards. Health. The bill would, by June 1, 2018, require the division to submit to the board the proposed regulation. The bill would, by July 1, 2019, require the board to adopt the proposed regulation.

The bill would provide that compliance with general room ventilation standards or the use of surgical masks or respirators does not satisfy the requirements for protection from surgical plumes under these provisions. The bill would provide that the use of respirators does not satisfy the requirements for protection from surgical plumes under these provisions, except as specified. The bill would require the manufacturer of a plume scavenging system to provide evidence that the system meets specified minimum requirements when installed, operated, and maintained in accordance with the manufacturers instructions.

By expanding the definition of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Under existing law, the Occupational Safety and Health Standards Board within the Department of Industrial Relations promulgates and enforces occupational safety and health standards for the state, including standards dealing with toxic materials and harmful physical agents. A violation of these standards and regulations under specific circumstances is a crime.

This bill would require the board, by June 1, 2018, to adopt standards to protect health care personnel and patients from plume, defined as noxious airborne contaminants generated as byproducts of the use of specific devices during surgical, diagnostic, or therapeutic procedures. The bill would require the board, in adopting these standards, to take into consideration and use as a benchmark certain standards adopted by specified organizations. The bill would require the board to use as the mandated requirement for plume scavenging systems recommendations of the federal Occupational Safety and Health Administration or National Institute for Occupational Safety and Health, where the board determines those recommendations are more effective in the evacuation of plume and would be more protective of occupational health than the described standards.

The bill would require the board, as part of the standards, to include a requirement that employers provide training to all health care workers involved in procedures that involve the creation of plume, as specified.

The bill would provide that compliance with general room ventilation standards or the use of surgical masks or respirators does not satisfy the requirements for protection from surgical plumes under these provisions. The bill would require the manufacturer of a plume scavenging system to provide evidence that the system meets specified minimum requirements when installed, operated, and maintained in accordance with the manufacturers instructions.

By expanding the definition of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Under existing law, the Occupational Safety and Health Standards Board within the Department of Industrial Relations promulgates and enforces occupational safety and health standards for the state, including standards dealing with toxic materials and harmful physical agents. A violation of these standards and regulations under specific circumstances is a crime.

This bill would require the board board, by June 1, 2018, to adopt standards to protect health care personnel and patients from plume, defined as noxious airborne contaminants generated as byproducts of the use of specific devices during surgical, diagnostic, or therapeutic procedures. The bill would require the board, in adopting these standards, to take into consideration and use as a benchmark certain standards adopted by specified organizations. The bill would require the board to use as the mandated requirement for plume scavenging systems recommendations of the federal Occupational Safety and Health Administration or National Institute for Occupational Safety and Health, where the board determines those recommendations are more effective in the evacuation of plume and would be more protective of occupational health than the described standards.

The bill would provide that compliance with general room ventilation standards or the use of surgical masks or respirators does not satisfy the requirements for protection from surgical plumes under these provisions.

By expanding the definition of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Under existing law, the Occupational Safety and Health Standards Board within the Department of Industrial Relations promulgates and enforces occupational safety and health standards for the state, including standards dealing with toxic materials and harmful physical agents. A violation of these standards and regulations under specific circumstances is a crime.

This bill would require the board to adopt standards to protect health care personnel and patients from plume, defined as noxious airborne contaminants generated as byproducts of the use of specific devices during surgical, diagnostic, or therapeutic procedures. The bill would require the board, in adopting these standards, to take into consideration and use as a benchmark certain standards adopted by specified organizations. The bill would require the board to use as the mandated requirement for plume scavenging systems recommendations of the federal Occupational Safety and Health Administration or National Institute for Occupational Safety and Health, where the board determines those recommendations are more effective in the evacuation of plume and would be more protective of occupational health than the described standards.

The bill would provide that compliance with general room ventilation standards or the use of surgical masks or respirators does not satisfy the requirements for protection from surgical plumes under these provisions.

By expanding the definition of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

GOVERNOR'S VETO

GV Bill Id:AB 2272

Author:(Thurmond)

As Enrolled Ver:September 9, 2016

2/3 vote

Original Committee Reference: L. & E.

SUMMARY: Requires the Division of Occupational Safety and Health (DOSH) 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," among other things. Specifically, this bill:

1. Requires that by July 1, 2019, the Occupational Safety and Health Standards Board (Board) adopt the proposed regulations from the advisory committee.
2. Allows the DOSH 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.
3. Mandates that in developing this regulation, the DOSH 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.
4. Stipulates that the use of surgical masks do not qualify as protection against plume.
5. 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.
6. Defines "plume" 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.
7. Defines "plume scavenging system" as smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that capture and neutralize plume before it can make ocular contact or contact with the respiratory tract of health care personnel or patients.

The Senate amendments:

1. Require DOSH, 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 exposure through the use of plume scavenging systems, as specified.
2. Require that by July 1, 2019, Board consider and adopt the proposed regulations.
3. State the proposed regulations/standards shall include a requirement that employers provide training to all health care personnel involved in procedures creating exposure to vaporized human tissue.
4. Specify that the regulation shall not limit the authority of DOSH or the Board to develop or adopt regulations that are broader in scope or application than those established in the bill.
5. Make clarifying changes.

EXISTING LAW establishes the Board within the Department of Industrial Relations (DIR) which promulgates and enforces occupational safety and health standards for the state including standards dealing with toxic materials and harmful physical agents.

FISCAL EFFECT: According to the Senate Appropriations Committee, the DIR 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 DOSH would incur unknown enforcement costs once the standards have been developed

COMMENTS: According to the sponsors, the California Nurses Association/National Nurses United, a Nurses' Health Study found that operating room nurses, "were at significantly higher risk of severe persistent asthma" as a result of occupational exposure to the dangerous and infectious materials that can be found in surgical plume smoke.^[1] By adopting standards to remove these infectious airborne contaminants before they are dispersed into the surgical suite and surrounding areas, California could be a leader in the reduction of hazardous exposure to surgical plume which could prove beneficial both to health care providers and their patients.

The Federal Occupational Safety and Health Administration (OSHA) can cite hospitals for not making an effort to control smoke emission in laser or electrosurgical procedures through a clause that covers all hazardous conditions. In Section 5(a)(1) of the Occupational Safety and Health Act, OSHA's General Duty Clause states:

Each employer shall furnish to each of his [sic] employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his [sic] employees.

However OSHA's limited ability to enforce elimination of unsafe practices involving such surgical procedures has led many to stress the need for a more concentrated campaign.

GOVERNOR'S VETO MESSAGE:

"This bill would require the Occupational Safety and Health Standards Board to adopt a regulation that requires a health facility to remove plume through the use of plume scavenging systems by July 1, 2019.

I agree with the author and sponsor that the potentially hazardous effects of plume merits thorough review. By specifically requiring the adoption of the regulation, however, the bill divests the Standards Board of its discretion to consider a proposed standard for adoption and instead mandates it to do so. This Board was created as an independent body and I believe that independence must be maintained in order for it to effectively perform its mission and protect all California workers."

Analysis Prepared by: Lorie Alvarez / L. & E. / (916) 319-2091 FN: 0005104

1. Nurses' Health Studies are among the largest ongoing investigations of factors that influence nurses' health. Started in 1976 and expanded in 1989, the information provided by 238,000 dedicated nurse participants has led to insights on health and disease. ↑

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 2272

Author:(Thurmond)

As Amended Ver:August 15, 2016

Majority vote

Original Committee Reference: L. & E.

SUMMARY: Requires the Division of Occupational Safety and Health (DOSH) 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," among other things. Specifically, this bill:

1. Requires that by July 1, 2019, the Occupational Safety and Health Standards Board (Board) adopt the proposed regulations from the advisory committee.
2. Allows the DOSH 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.
3. Mandates that in developing this regulation, the DOSH 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.
4. Stipulates that the use of surgical masks do not qualify as protection against plume.
5. 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.
6. Defines "plume" 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.
7. Defines "plume scavenging system" as smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that capture and neutralize plume before it can make ocular contact or contact with the respiratory tract of health care personnel or patients.

The Senate amendments:

1. Require DOSH, 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 exposure through the use of plume scavenging systems, as specified.
2. Require that by July 1, 2019, Board consider and adopt the proposed regulations.
3. State the proposed regulations/standards shall include a requirement that employers provide training to all health care personnel involved in procedures creating exposure to vaporized human tissue.
4. Specify that the regulation shall not limit the authority of DOSH or the Board to develop or adopt regulations that are broader in scope or application than those established in the bill.
5. Make clarifying changes.

EXISTING LAW establishes the Board within the Department of Industrial Relations (DIR) which promulgates and enforces occupational safety and health standards for the state including standards dealing with toxic materials and harmful physical agents.

FISCAL EFFECT: According to the Senate Appropriations Committee, the DIR 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 DOSH would incur unknown enforcement costs once the standards have been developed

COMMENTS: According to the sponsors, the California Nurses Association/National Nurses United, a Nurses' Health Study found that operating room nurses, "were at significantly higher risk of severe persistent asthma" as a result of occupational exposure to the dangerous and infectious materials that can be found in surgical plume smoke.^[1] By adopting standards to remove these infectious airborne contaminants before they are dispersed into the surgical suite and surrounding areas, California could be a leader in the reduction of hazardous exposure to surgical plume which could prove beneficial both to health care providers and their patients.

Federal Occupational Safety and Health Administration (OSHA) can cite hospitals for not making an effort to control smoke emission in laser or electrosurgical procedures through a clause that covers all hazardous conditions. In Section 5(a)(1) of the Occupational Safety and Health Act, OSHA's General Duty Clause states:

Each employer shall furnish to each of his [sic] employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his [sic] employees.

However OSHA's limited ability to enforce elimination of unsafe practices involving such surgical procedures has led many to stress the need for a more concentrated campaign.

Analysis Prepared by: Lorie Alvarez / L. & E. / (916) 319-2091 FN: 0004407

1. Nurses' Health Studies are among the largest ongoing investigations of factors that influence nurses' health. Started in 1976 and expanded in 1989, the information provided by 238,000 dedicated nurse participants has led to insights on health and disease. ↑

 THIRD READING  

Bill No: AB 2272

Author:

:

Vote:

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:

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.

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 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.
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 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: Fiscal Com.: Local:

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: (Verified 6/22/16)

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: (Verified 6/22/16)

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.

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

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:

8/15/16 19:39:46

**** END ****

SENATE COMMITTEE ON

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 2272 (Thurmond) - Occupational safety and health standards: plume

*********** ANALYSIS ADDENDUM – SUSPENSE FILE ***********

The following information is revised to reflect amendments

adopted by the committee on August 11, 2016

Bill Summary:

AB 2272 would require the Occupational Safety and Health Standards Board, by June 1, 2018, to adopt standards and require training and education to protect health care personnel and patients from exposure to vaporized human tissue.

Fiscal Impact:

The Department of Industrial Relations (DIR) 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.

Author Amendments:

Make clarifying changes.

-- END --

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 2272 (Thurmond) - Occupational safety and health standards: plume

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

AB 2272 would require the Occupational Safety and Health Standards Board, by June 1, 2018, to adopt standards and require training and education to protect health care personnel and patients from exposure to vaporized human tissue.

Fiscal Impact:

The Department of Industrial Relations (DIR) 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.

Background:

Current law establishes the Occupational Safety and Health Standards Board (Board), within DIR, as the standards-setting agency for the Division of Occupational Safety and Health (DOSH). The Board promulgates and enforces occupational safety and health standards for the state including standards dealing with toxic materials and harmful physical agents. Additionally, current law 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.

Proposed Law:

This bill would, among other things, do all of the following:

• Require the Board, by June 1, 2018, to adopt standards to protect health care personnel and patients from plume (see below) exposure through the use of plume scavenging systems.
• Mandate that in developing these standards, the Board will consider the most effective preexisting plume-related standards including those at the federal level. The Board may also consider input from health facilities, physicians, registered nurses, affected health care personnel, labor and specialty organizations representing affected registered nurses and health care personnel, and other stakeholders.
• Specify the Board to include as part of the standards a requirement for employers to provide training and education, as specified, to all health care workers that will participate in procedures that involve the creation of a plume.
• Define “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.
• Define devices that remove plume from the air as “plume scavenging systems” that include smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that capture and neutralize at least 95 percent of plume at the site of origin before plume can make ocular contact or contact with the respiratory tract of health care personnel or patients.

Staff Comments:

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. Under this bill, California would be the first state to create a standard related to plume exposure and removal.

Any local government costs resulting from the mandate in this measure are not state-reimbursable because the mandate only involves the definition of a crime or the penalty for conviction of a crime.

-- END --

SENATE COMMITTEE ON LABOR AND INDUSTRIAL RELATIONS

Senator Tony Mendoza, Chair

2015 - 2016 Regular

Bill No: AB 2272 Hearing Date: June 22, 2016

Subject: Occupational safety and health standards: plume

KEY ISSUE

Should the Legislature require the Occupational Safety and Health Standards Board to adopt standards and require training and education to protect health care personnel and patients from exposure to vaporized human tissue, defined in this bill as “plume”?

ANALYSIS

Existing law

• 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).
• 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

• Requires the Board, by June 1, 2018, to adopt standards to protect health care personnel and patients from plume (see below) exposure through the use of plume scavenging systems.
• Mandates that in developing these standards, the Board will consider the most effective preexisting plume-related standards including those at the federal level. The Board may also consider input from health facilities, physicians, registered nurses, affected health care personnel, labor and specialty organizations representing affected registered nurses and health care personnel, and other stakeholders.
• 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.
• Defines devices that remove plume from the air as “plume scavenging systems” that include smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that capture and neutralize at least 95 percent of plume at the site of origin before plume can make ocular contact or contact with the respiratory tract of health care personnel or patients.
• Creates a plume, and plume exposure prevention education and training requirement to be provided by employers for health care workers who may encounter plume.
• States that its provisions do not alter or affect general room ventilation standards in any way.
• Stipulates that the use of surgical masks or respirators alone do not qualify as protection against plume.

COMMENTS

1. 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.

2. Sources to Be Considered in Developing a Plume Prevention Standard

This bill specifically directs the Board to use the benchmarks set by the International Standards Organization (ISO) and the CSA Group, unless federal Occupational Safety and Health Administration (OSHA) or National Institute for Occupational Safety and Health (NIOSH) recommendations are more effective in the evacuation of plume.

ISO 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 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.

3. 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.

2. Proponent Arguments:

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.

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.

3. Opponent Arguments:

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.

4. Prior Legislation:

None.

SUPPORT

California Nurses Association/National Nurses United (Sponsor)

American Lung Association in California

California Labor Federation, AFL-CIO

Service Employees International Union

The International Council on Surgical Plume

OPPOSITION

California Hospital Association

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 2272

Author:(Thurmond)

As Introduced Ver:February 18, 2016

Majority vote

SUMMARY: Requires the Occupational Safety and Health Standards Board (Board) to adopt standards to protect healthcare personnel and patients from noxious airborne contaminants "plume" generated during specified medical procedures. Specifically, this bill:

1. Requires the Board by June 1, 2018 to adopt standards requiring a health facility to evacuate or remove plume in all settings that employ techniques which create plume.
2. Directs the Board to consider and use as benchmarks standards established by the International Organization for Standardization (ISO) and the Canadian Standards Association (CSA) unless federal Occupational Safety and Health Administration (OSHA) or the National Institute for Occupational Safety and Health (NIOSH) recommendations are more effective in the evacuation of plume and would be more protective of occupational health.
3. Defines "plume" as 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.
4. Defines "plume scavenging system" as smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that capture and neutralize at least 95% of plume before plume can make contact with eyes or contact with the respiratory tract of healthcare personnel or patients.
5. States the use of surgical masks or respirators do not satisfy the requirements under this bill.

EXISTING LAW establishes the Board within the Department of Industrial Relations (DIR) which promulgates and enforces occupational safety and health standards for the state including standards dealing with toxic materials and harmful physical agents.

FISCAL EFFECT: According to the Assembly Appropriations Committee, the Board indicates the costs associated with the development of a standard requiring a health facility to evacuate or remove plume, as specified, would be absorbable and within the scope of existing workload. The Board would rely on the recommended benchmarks developed by the CSA and ISO to guide their work.

Unknown enforcement costs to the Division of Occupational Safety and Health (DOSH) once the bill is implemented.

COMMENTS: According to the sponsors, the California Nurses Association/National Nurses United, a Nurses' Health Study found that operating room nurses, "were at significantly higher risk of severe persistent asthma" as a result of occupational exposure to the dangerous and infectious materials that can be found in surgical plume smoke.^[1] By adopting standards to remove these infectious airborne contaminants before they are dispersed into the surgical suite and surrounding areas, California could be a leader in the reduction of hazardous exposure to surgical plume which could prove beneficial both to health care providers and their patients.

Federal OSHA can cite hospitals for not making an effort to control smoke emission in laser or electrosurgical procedures through a clause that covers all hazardous conditions. In Section 5(a)(1) of the Occupational Safety and Health Act, OSHA's General Duty Clause states:

Each employer shall furnish to each of his [sic] employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his [sic] employees.

However OSHA's limited ability to enforce elimination of unsafe practices involving such surgical procedures has led many to stress the need for a more concentrated campaign. "In many ways, this is an education issue rather than an enforcement issue," says Vangie Dennis, R.N., C.N.O.R., C.M.L.S.O., advanced technology manager, surgical services support, at Gwinnett Medical Center near Atlanta, Georgia. Ms. Dennis says "there are still operating room personnel who are unaware of the issue, who do not realize that they are breathing human body parts. There are surgeons using smoke evacuators for laser procedures but not electrosurgery, which is actually more dangerous because this procedure emits more particulates." In her role at Gwinnett, Ms Dennis, helped transform the way surgical smoke is dealt with at Gwinnett. "In the past, there was inconsistent use of smoke evacuators and no real understanding of the hazards of electrosurgical smoke," she says. "We now use smoke evacuators with any procedure that emits smoke. Getting to that point involved a proactive strategy to optimize workplace safety."^[2]

Arguments in Support

The sponsors argue that the Joint Commission on Accreditation of Healthcare Organizations and NIOSH has called for a reduction of plume exposure to healthcare workers and yet a federal legislative mandate has not been forthcoming. California is one of many states that as an OSHA approved state plan that allows for the adoption of occupational standards without having to resort to the onerous federal process. Our state should take the lead on this important issue as it has in areas like occupational exposure to blood borne pathogens, Ebola virus, safe patient handling, and workplace violence standards.

Arguments in Opposition

The California Hospital Association, are opposed to this bill unless amended, stating "the equipment at issue in this bill directly implicates patient care decisions. The hospital together with physicians, select devices that may generate plume as well as devices that could minimize exposure to plume because of the patient care considerations. Once in the operating room, the physician is in charge. Because most hospitals do not employ their physicians (and most private hospitals are prohibited from doing so) the hospital’s ability to impact decisions made by physicians in the operating room may be limited and as noted above, could interfere with patient care."

They argue that directing the Board to utilize specific guidance is too prescriptive particularly where the guidance referenced is from a non-traditional source. Guidance can change over time, new guidance could be published before the Board begins its process and/or there may be more appropriate guidance available currently. Lastly, they state it is not operationally feasible to take guidance documents reflecting numerous options and convert those options into mandates.

Analysis Prepared by: Lorie Alvarez / L. & E. / (916) 319-2091 FN: 0002844

1. Nurses' Health Studies are among the largest ongoing investigations of factors that influence nurses' health. Started in 1976 and expanded in 1989, the information provided by 238,000 dedicated nurse participants has led to insights on health and disease. ↑

2. Environment of Care® News, September 2007, Volume 10, Issue 9- Joint Commission on Accreditation of Healthcare Organizations ↑

Date of Hearing: May 4, 2016

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

ABPCA Bill Id:AB 2272

Author:(Thurmond) – As Introduced Ver:February 18, 2016

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill requires the Occupational Safety and Health Standards Board (Board) to adopt standards to protect healthcare personnel and patients from noxious airborne contaminants "plume" generated during specified medical procedures. Specifically, this bill:

1. Requires the Board to adopt by June 1, 2018, an occupational safety and health standard requiring a health facility, to evacuate or remove plume through the use of a plume scavenging system in all settings that employ techniques that involve the creation of plume.
2. Requires the Board to take into consideration and use as a benchmark, specific standards adopted by the International Organization for Standardization (IOS) and the Canadian Standards Association (CSA). If the Board determines recommendations of the federal Occupational Safety and Health Administration or National Institute for Occupational Safety and Health are more effective in the evacuation of plume and would be more protective of occupational health than the ISO or CSA standards, the board must use those federal recommendations as the mandated requirement for plume scavenging systems.
3. Authorizes the Board to consider input from health facilities, practicing physicians from affected specialties, labor and specialty organizations representing affected registered nurses, labor and specialty organizations representing other affected health care personnel, and other stakeholders.
4. Specifies nothing in this bill alters amends, expands, or reduces existing general room ventilation standards or requirements. These plume scavenging standards are in addition to general room ventilation standards or requirements. Prohibits the use of surgical masks or respirators to satisfy the requirement of this bill.
5. Defines the following for purposes of the bill:
   1. “Plume” to mean 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.
   2.  “Plume scavenging system” to mean smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that capture and neutralize at least 95 percent of plume at the site of origin and before plume can make ocular contact or contact with the respiratory tract of health care personnel or patients

FISCAL EFFECT:

The Occupational Safety and Health Standards Board indicates the costs associated with the development of a standard requiring a health facility to evacuate or remove plume, as specified, would be absorbable and within the scope of existing workload. The Board would rely on the recommended benchmarks developed by the CSA and ISO to guide their work.

Unknown enforcement costs to the Division of Occupational Safety and Health (DOSH) once the bill is implemented.

COMMENTS:

1. Purpose. According to the sponsors, the California Nurses Association/National Nurses United, operating room nurses are at significantly higher risk of severe persistent asthma as a result of occupational exposure to the dangerous and infectious materials that can be found in surgical plume smoke. Information from the sponsor states, for example, surgeons are using smoke evacuators for laser procedures but not electrosurgery, which is actually more dangerous because this procedure emits more particulates. Adopting standards to remove these infectious airborne contaminants before they are dispersed into the surgical suite and surrounding areas, could make California a leader in the reduction of hazardous exposure to surgical plume which could prove beneficial both to health care providers and their patients.
2. Background. California would be the first state to create a standard related to plume exposure and removal if this bill were enacted. Both the privately run Joint Commission on Accreditation of Healthcare Organizations and federal NIOSH have called for the reduction of plume exposure to healthcare workers.

This bill recommends the Board consider recommendations made by the CSA and the ISO. The CSA is a nationally recognized testing laboratory involved in a wide range of testing and standards drafting in the areas such as construction, automotive, aerospace, and personal protective equipment. The ISO is an independent, non-governmental international organization that provides specifications for products, services and systems, to ensure quality, safety and efficiency. The ISO has published more than 19,000 International Standards and related documents, covering almost every industry, from technology, to food safety, to agriculture and healthcare.

1. Opposition. The California Hospital Association, is opposed to this bill. It states the hospital, together with physicians, select devices that may generate plume as well as devices that could minimize exposure to plume because of the patient care considerations. The association is concerned that directing the Board to utilize specific guidance is too prescriptive.

Analysis Prepared by: Misty Feusahrens / APPR. / (916) 319-2081

Date of Hearing: April 20, 2016

ASSEMBLY COMMITTEE ON LABOR AND EMPLOYMENT

Roger Hernández, Chair

ABPCA Bill Id:AB 2272 (

Author:Thurmond) – As Introduced Ver:February 18, 2016

SUBJECT: Occupational safety and health standards: plume

SUMMARY: Requires the Occupational Safety and Health Standards Board (Board) to adopt standards to protect healthcare personnel and patients from noxious airborne contaminants "plume" generated during specified medical procedures. Specifically, this bill:

1. Requires the Board by June 1, 2018 to adopt standards requiring a health facility to evacuate or remove plume in all settings that employ techniques which create plume.
2. Directs the Board to consider and use as benchmarks standards established by the International Organization for Standardization (ISO) and the Canadian Standards Association (CSA) unless federal Occupational Safety and Health Administration (OSHA) or the National Institute for Occupational Safety and Health (NIOSH) recommendations are more effective in the evacuation of plume and would be more protective of occupational health.
3. Defines "plume" as 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.
4. Defines "plume scavenging system" as smoke evacuators, laser plume evacuators, plume scavengers, and local exhaust ventilators that capture and neutralize at least 95 percent of plume before plume can make contact with eyes or contact with the respiratory tract of healthcare personnel or patients.
5. States the use of surgical masks or respirators do not satisfy the requirements under this bill.

EXISTING LAW: Establishes the Board within the Department of Industrial Relations (DIR) which promulgates and enforces occupational safety and health standards for the state including standards dealing with toxic materials and harmful physical agents.

FISCAL EFFECT: Unknown

COMMENTS: According to the sponsors, the California Nurses Association/National Nurses United, a Nurses' Health Study found that operating room nurses, "were at significantly higher risk of severe persistent asthma" as a result of occupational exposure to the dangerous and infectious materials that can be found in surgical plume smoke.^[1] By adopting standards to remove these infectious airborne contaminants before they are dispersed into the surgical suite and surrounding areas, California could be a leader in the reduction of hazardous exposure to surgical plume which could prove beneficial both to health care providers and their patients.

Federal OSHA can cite hospitals for not making an effort to control smoke emission in laser or electrosurgical procedures through a clause that covers all hazardous conditions. In Section 5(a)(1) of the Occupational Safety and Health Act, OSHA’s General Duty Clause states:

Each employer shall furnish to each of his [sic] employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his [sic] employees.

However OSHA’s limited ability to enforce elimination of unsafe practices involving such surgical procedures has led many to stress the need for a more concentrated campaign. “In many ways, this is an education issue rather than an enforcement issue,” says Vangie Dennis, R.N., C.N.O.R., C.M.L.S.O., advanced technology manager, Surgical Services Support, at Gwinnett Medical Center near Atlanta. Ms. Dennis, says "there are still operating room personnel who are unaware of the issue, who do not realize that they are breathing human body parts. There are surgeons using smoke evacuators for laser procedures but not electrosurgery, which is actually more dangerous because this procedure emits more particulates.” In her role at Gwinnett, Ms Dennis, helped transform the way surgical smoke is dealt with at Gwinnett. “In the past, there was inconsistent use of smoke evacuators and no real understanding of the hazards of electrosurgical smoke,” she says. “We now use smoke evacuators with any procedure that emits smoke. Getting to that point involved a proactive strategy to optimize workplace safety.”^[2]

ISO Standard on Systems for Evacuation of Plume Generated by Medical Devices

ISO is an independent, non-governmental international organization with a membership of 161 national standards bodies. According to their website international standards make things work. They give world-class specifications for products, services and systems, to ensure quality, safety and efficiency.

ISO has published more than 19000 International Standards and related documents, covering almost every industry, from technology, to food safety, to agriculture and healthcare. ISO International Standards impact everyone, everywhere.

ISO Standard 16571:2014 specifies requirements and guidelines for the design, manufacture, installation, function, performance, maintenance, servicing, documentation, testing, and commissioning of equipment for evacuation of plume generated by medical devices.

NIOSH Recommendations

As part of the Centers for Disease Control (CDC), NIOSH is responsible for conducting research and making recommendations for the prevention of work-related illnesses and injuries.

According to information published on their website, during surgical procedures using a laser or electrosurgical unit, the thermal destruction of tissue creates a smoke byproduct. Research studies have confirmed that this smoke plume can contain toxic gases and vapors such as benzene, hydrogen cyanide, and formaldehyde, bio-aerosols, dead and live cellular material (including blood fragments), and viruses. At high concentrations the smoke causes ocular and upper respiratory tract irritation in health care personnel, and creates visual problems for the surgeon. The smoke has unpleasant odors and has been shown to have mutagenic potential.

NIOSH research has shown airborne contaminants generated by these surgical devices can be effectively controlled. Two methods of control are recommended by NIOSH:

Ventilation

Recommended ventilation techniques include a combination of general room and local exhaust ventilation (LEV). General room ventilation is not by itself sufficient to capture contaminants generated at the source. The two major LEV approaches used to reduce surgical smoke levels for health care personnel are portable smoke evacuators and room suction systems.

Smoke evacuators contain a suction unit (vacuum pump), filter, hose, and an inlet nozzle. The smoke evacuator should have high efficiency in airborne particle reduction and should be used in accordance with the manufacturer's recommendations to achieve maximum efficiency. A capture velocity of about 100 to 150 feet per minute at the inlet nozzle is generally recommended. It is also important to choose a filter that is effective in collecting the contaminants. A High Efficiency Particulate Air (HEPA) filter or equivalent is recommended for trapping particulates. Various filtering and cleaning processes also exist which remove or inactivate airborne gases and vapors. The various filters and absorbers used in smoke evacuators require monitoring and replacement on a regular basis and are considered a possible biohazard requiring proper disposal.

Room suction systems can pull at a much lower rate and were designed primarily to capture liquids rather than particulate or gases. If these systems are used to capture generated smoke, users must install appropriate filters in the line ensure that the line is cleared, and that filters are disposed of properly. Generally speaking, the use of smoke evacuators is more effective than room suction systems to control the generated smoke from non-endoscopic laser/electric surgical procedures.

Work Practices

The smoke evacuator or room suction hose nozzle inlet must be kept within two inches of the surgical site to effectively capture airborne contaminants generated by these surgical devices. The smoke evacuator should be ON (activated) at all times when airborne particles are produced during all surgical or other procedures. At the completion of the procedure all tubing, filters, and absorbers must be considered infectious waste and be disposed appropriately. New filters and tubing should be installed on the smoke evacuator for each procedure. While there are many commercially available smoke evacuator systems to select from, all of these LEV systems must be regularly inspected and maintained to prevent possible leaks. Users shall also utilize control measures such as "universal precautions," as required by the OSHA Blood-Borne Pathogen standard.

Federal OSHA Recommendations

During surgical procedures that use a laser or electrosurgical unit, the thermal destruction of tissue creates a smoke byproduct. Each year, an estimated 500,000 workers, including surgeons, nurses, anesthesiologists, and surgical technologists, are exposed to laser or electrosurgical smoke. Surgical plumes have contents similar to other smoke plumes, including carbon monoxide, polyaromatic hydrocarbons, and a variety of trace toxic gases. As such, they can produce upper respiratory irritation, and have in-vitro mutagenic potential. Although there has been no documented transmission of infectious disease through surgical smoke, the potential for generating infectious viral fragments, particularly following treatment of venereal warts, exists. Local smoke evacuation systems have been recommended by consensus organizations, and may improve the quality of the operating field. Employers should be aware of this emerging problem and advise employees of the hazards of laser smoke.

There are currently no specific OSHA standards for laser/electrosurgery plume hazards however they make the following recommendations:

• Use portable smoke evacuators and room suction systems with inline filters.
• Keep the smoke evacuator or room suction hose nozzle inlet within two inches of the surgical site to effectively capture airborne contaminants.
• Have a smoke evacuator available for every operating room where plume is generated.
• Evacuate all smoke, no matter how much is generated.
• Keep smoke evacuator "ON" (activated) at all times when airborne particles are produced during all surgical or other procedures.
• Consider all tubing, filters, and absorbers as infectious waste and dispose of them appropriately. Use Universal Precautions as required by the OSHA Bloodborne Pathogens Standard when contaminated with blood or OPIM [29 CFR 1910.1030(d)(1)].
• Use new tubing before each procedure and replace the smoke evacuator filter as recommended by the manufacturer.
• Inspect smoke evacuator systems regularly to ensure proper functioning.

Arguments in Support

The sponsors argue that the Joint Commission on Accreditation of Healthcare Organizations and NIOSH has called for a reduction of plume exposure to healthcare workers and yet a federal legislative mandate has not been forthcoming. California is one of many states that as an OSHA approved state plan that allows for the adoption of occupational standards without having to resort to the onerous federal process. Our state should take the lead on this important issue as it has in areas like occupational exposure to blood borne pathogens, Ebola virus, safe patient handling, and workplace violence standards.

Arguments in Opposition

The California Hospital Association, are opposed to this bill unless amended, stating "the equipment at issue in this bill directly implicates patient care decisions. The hospital together with physicians, select devices that may generate plume as well as devices that could minimize exposure to plume because of the patient care considerations. Once in the operating room, the physician is in charge. Because most hospitals do not employ their physicians (and most private hospitals are prohibited from doing so) the hospital’s ability to impact decisions made by physicians in the operating room may be limited and as noted above, could interfere with patient care."

They argue that directing the Board to utilize specific guidance is too prescriptive particularly where the guidance referenced is from a non-traditional source. Guidance can change over time, new guidance could be published before the Board begins its process and/or there may be more appropriate guidance available currently. Lastly, they state it is not operationally feasible to take guidance documents reflecting numerous options and convert those options into mandates.

REGISTERED SUPPORT / OPPOSITION:

Support

California Nurses Association/National Nurses United (sponsor)

Opposition (Unless Amended)

California Hospital Association

Analysis Prepared by: Lorie Alvarez / L. & E. / (916) 319-2091

1. Nurses' Health Studies are among the largest ongoing investigations of factors that influence nurses' health. Started in 1976 and expanded in 1989, the information provided by 238,000 dedicated nurse participants has led to insights on health and disease. ↑

2. Environment of Care® News, September 2007, Volume 10, Issue 9- Joint Commission on Accreditation of Healthcare Organizations ↑