AB 402: Occupational safety and health standards: plume.
- Session Year: 2017-2018
- House: Assembly
- Latest Version Date: 2017-09-13
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, 2018, 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 regulations 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 regulations, 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, 2019, require the division to submit to the board a proposed regulation. The bill would, by July 1, 2020, require the board to adopt a 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, by June 1, 2018, 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 regulations 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 regulations, 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, 2019, require the division to submit to the board a proposed regulation. The bill would, by July 1, 2020, require the board to adopt a 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.
(a)As used in this section:
(1)Division means the Division of Occupational Safety and Health.
(2)Electrocautery device means a device that is electrically heated to cut, ablate, or coagulate human tissue for therapeutic purposes.
(3)Electrosurgical device means a device that uses a radio frequency electric current passing through the patient to cut, ablate, or coagulate human tissue for therapeutic purposes.
(4)Energy-based device means a device that uses energy to ablate, cauterize, or mechanically manipulate target human tissue including lasers, electrosurgical generators, broadband light sources, ultrasonic instruments, plasma generators, bone saws, and drills.
(5)Health facility means a health facility as defined in subdivision (a) of Section 1250 of the Health and Safety Code.
(6)Plume means 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)Plume scavenging system means 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.
(b)(1)The division, by June 1, 2018, shall 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. The advisory committee may 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, labor and specialty organizations representing other affected health care personnel, and other stakeholders.
(2)By June 1, 2019, the division shall submit to the board a proposed regulation 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.
(3)In developing regulations, the division shall do all of the following:
(A)Evaluate using as a benchmark the standards titled Systems for evacuation of plume generated by medical devices (ISO 16571) adopted by the International Organization for Standardization and the standards titled Plume scavenging in surgical, diagnostic, therapeutic, and aesthetic settings (CSA Z305.13-13) adopted by the CSA Group.
(B)Take into consideration recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health.
(C)Take into consideration the standards titled Systems for evacuation of plume generated by medical devices (ISO 16571) adopted by the International Organization for Standardization in developing a standard establishing how much plume shall be captured by a plume scavenging system.
(D)Include a requirement in the regulation for employers to provide training to all workers foreseeably participating in procedures that involve the creation of plume. The training shall include, but not be limited to, general education on the contents of plume, the circumstances in which it is generated, the associated health and safety hazards, and appropriate use of the plume scavenging equipment and systems utilized by the health facility. The training shall be designed to provide an opportunity for interactive questions and answers with a person knowledgeable about occupational exposure to plume and the specific equipment utilized to scavenge plume.
(c)The board shall, by July 1, 2020, adopt a proposed regulation of the division, except as specified in subdivision (f), 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.
(d)(1)Nothing in this section 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, and compliance with general room ventilation standards shall not satisfy the requirements of this section.
(2)Evidence that the plume scavenging system conforms to the minimum requirements of this section when installed, operated, and maintained in accordance with the manufacturers instructions, shall be provided by the manufacturer.
(e)The use of surgical masks shall not satisfy the requirements of this section. The use of respirators shall not satisfy the requirements of this section except when, due to medical necessity, the plume scavenging system is not able to be located where it effectively captures plume.
(f)This section shall not limit the authority of the division to develop a regulation, or the authority of the board to adopt a regulation, that is broader in scope or broader in application than required by this section.
SEC. 2.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)As used in this section:
(1)Division means the Division of Occupational Safety and Health.
(2)Electrocautery device means a device that is electrically heated to cut, ablate, or coagulate human tissue for therapeutic purposes.
(3)Electrosurgical device means a device that uses a radio frequency electric current passing through the patient to cut, ablate, or coagulate human tissue for therapeutic purposes.
(4)Energy-based device means a device that uses energy to ablate, cauterize, or mechanically manipulate target human tissue including lasers, electrosurgical generators, broadband light sources, ultrasonic instruments, plasma generators, bone saws, and drills.
(5)Health facility means a health facility as defined in subdivision (a) of Section 1250 of the Health and Safety Code.
(6)Plume means 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)Plume scavenging system means 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.
(b)(1)The division, by June 1, 2018, shall 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. The advisory committee may 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, labor and specialty organizations representing other affected health care personnel, and other stakeholders.
(2)By June 1, 2019, the division shall submit to the board a proposed regulation 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.
(3)In developing regulations, the division shall do all of the following:
(A)Evaluate using as a benchmark the standards titled Systems for evacuation of plume generated by medical devices (ISO 16571) adopted by the International Organization for Standardization and the standards titled Plume scavenging in surgical, diagnostic, therapeutic, and aesthetic settings (CSA Z305.13-13) adopted by the CSA Group.
(B)Take into consideration recommendations on the evacuation of plume from the federal Occupational Safety and Health Administration and National Institute for Occupational Safety and Health.
(C)Take into consideration the standards titled Systems for evacuation of plume generated by medical devices (ISO 16571) adopted by the International Organization for Standardization in developing a standard establishing how much plume shall be captured by a plume scavenging system.
(D)Include a requirement in the regulation for employers to provide training to all workers foreseeably participating in procedures that involve the creation of plume. The training shall include, but not be limited to, general education on the contents of plume, the circumstances in which it is generated, the associated health and safety hazards, and appropriate use of the plume scavenging equipment and systems utilized by the health facility. The training shall be designed to provide an opportunity for interactive questions and answers with a person knowledgeable about occupational exposure to plume and the specific equipment utilized to scavenge plume.
(c)The board shall, by July 1, 2020, adopt a proposed regulation of the division, except as specified in subdivision (f), 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.
(d)(1)Nothing in this section 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, and compliance with general room ventilation standards shall not satisfy the requirements of this section.
(2)Evidence that the plume scavenging system conforms to the minimum requirements of this section when installed, operated, and maintained in accordance with the manufacturers instructions, shall be provided by the manufacturer.
(e)The use of surgical masks shall not satisfy the requirements of this section. The use of respirators shall not satisfy the requirements of this section except when, due to medical necessity, the plume scavenging system is not able to be located where it effectively captures plume.
(f)This section shall not limit the authority of the division to develop a regulation, or the authority of the board to adopt a regulation, that is broader in scope or broader in application than required by this section.
SEC. 2.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
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Date
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Status
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| Jan 12, 2018 | Stricken from file. |
| Jan 3, 2018 | Consideration of Governor's veto pending. |
| Oct 9, 2017 | Vetoed by Governor. |
| Sep 20, 2017 | Enrolled and presented to the Governor at 4:30 p.m. |
| Sep 11, 2017 | In Assembly. Ordered to Engrossing and Enrolling. |
| Sep 11, 2017 | Read third time. Passed. Ordered to the Assembly. |
| Sep 5, 2017 | Read second time. Ordered to third reading. |
| Sep 1, 2017 | From committee: Do pass. (Ayes 5. Noes 2.) (September 1). |
| Jul 10, 2017 | In committee: Referred to APPR. suspense file. |
| Jun 28, 2017 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 3. Noes 1.) (June 28). Re-referred to Com. on APPR. |
| Jun 8, 2017 | Referred to Com. on L. & I.R. |
| May 30, 2017 | In Senate. Read first time. To Com. on RLS. for assignment. |
| May 30, 2017 | Read third time. Passed. Ordered to the Senate. (Ayes 55. Noes 21. Page 1785.) |
| Apr 6, 2017 | Read second time. Ordered to third reading. |
| Apr 5, 2017 | From committee: Do pass. (Ayes 12. Noes 5.) (April 5). |
| Mar 16, 2017 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 6. Noes 1.) (March 15). Re-referred to Com. on APPR. |
| Feb 21, 2017 | Referred to Com. on L. & E. |
| Feb 10, 2017 | From printer. May be heard in committee March 12. |
| Feb 9, 2017 | Read first time. To print. |
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Date
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Description
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Location
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Votes
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| Sep 11, 2017 | Assembly 3rd Reading AB402 Thurmond By Hernandez | Senate Floor |
Passed |
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| Sep 1, 2017 | Do pass | Senate Standing Committee on Appropriations |
Passed |
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| Jul 10, 2017 | Placed on suspense file | Senate Standing Committee on Appropriations |
Passed |
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| Jun 28, 2017 | Do pass, but first be re-referred to the Committee on [Appropriations] | Senate Standing Committee on Labor and Industrial Relations |
Passed |
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| May 30, 2017 | AB 402 THURMOND Assembly Third Reading | Assembly Floor |
Passed |
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| Apr 5, 2017 | Do pass. | Assembly Standing Committee on Appropriations |
Passed |
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| Mar 15, 2017 | Do pass and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Labor and Employment |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
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Organization
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Position
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Date
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|---|---|---|
| American Lung Association - California | ** Support | Sep 4, 2017 |
| BERNIER CARR & ASSOCIATES | * Indeterminate | Mar 15, 2017 |
| Board of Registered Nursing | ** Support | Sep 4, 2017 |
| California Hospital Association | ** Against | Sep 4, 2017 |
| California Labor Federation, Afl-Cio | ** Support | Sep 4, 2017 |
| California Nurses Association | ** Support | Sep 4, 2017 |
| international council on surgical plume | * Support | Jun 28, 2017 |
| International Counsel and Surgical Plume | * Support | Mar 15, 2017 |
| National Nurses United | ** Support | Sep 4, 2017 |
GOVERNOR'S VETO
GV Bill Id:AB 402
Author:(Thurmond)
As Enrolled Ver:September 13, 2017
2/3 vote
Committee | Votes | Ayes | Noes |
Labor | 6-1 | Thurmond, Flora, Gomez, Kalra, McCarty, Reyes | Harper |
Appropriations | 12-5 | Gonzalez Fletcher, Bloom, Bocanegra, Bonta, Calderon, Chau, Eggman, Friedman, Eduardo Garcia, Gray, Muratsuchi, Reyes | Bigelow, Brough, Fong, Gallagher, Obernolte |
ASSEMBLY: | 55-21 | (May 30, 2017) | SENATE: | 28-12 | (September 11, 2017) |
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:
- Requires the Division of Occupational Safety and Health (Division) by June 1, 2018, to convene an advisory committee to develop a regulation, 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.
- Requires the division by June 1, 2019, to submit to the board a proposed regulation.
- Requires the board by July 1, 2020, to adopt a proposed regulation.
- Specifies 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 in this bill.
- Requires the division, in developing proposed regulations to do certain things, including evaluating the use of certain standards and recommendations adopted by specified organizations as a benchmark.
- Specifies that nothing in this section alters, amends, expands, or reduces existing general room ventilation standards or requirements and compliance with general room ventilation standards shall not satisfy the requirements of this section.
- States the use of surgical masks shall not satisfy the requirements of this section and that the use of respirators shall not satisfy the requirements of this section except as specified.
- Requires 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 manufacturer’s instructions.
- Mandates that a requirement is included in the regulation for employers to provide training to all workers foreseeably participating in procedures that involve the creation of plume. Specifies what the training shall include, but not be limited to.
- Defines "plume scavenging system" as 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.
- Defines various other terms for purposes of this section.
FISCAL EFFECT: According to the Assembly Appropriations Committee, minor and absorbable costs for the Division and the Board to develop regulations and unknown but likely minor enforcement costs to the Division once the bill is implemented.
COMMENTS: According to the author, 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. 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.
Arguments in Support
The California Labor Federation is in support of this measure and argues, "Surgical plume is also known to contain mutagenic (cancer producing) particles. One study equated the mutagenic condensate generated from one gram of tissue to three cigarettes from lasers and six cigarettes for electrocautery smoke. At high concentrations, exposure to plume is also known to cause ocular and upper respiratory tract irritation in health care personnel. The risks associated with surgical plume, unfortunately, are not eliminated by general room ventilation or the use of surgical masks. Instead, it requires the use of local exhaust ventilation placed close to the site where the smoke is generated. This bill will require the Cal/OSHA Standards Board to adopt regulations better protecting workers from this incredibly dangerous hazard. The bill includes specific language to guide and streamline the regulatory process and will, if enacted, prevent many catastrophic illnesses from occurring to affected employees."
Arguments in Opposition
The California Hospital Association opposes this measure unless amended and argues, "The hospital, together with the surgical team, selects devices that may generate plume as well as devices that could minimize exposure to plume because of patient care considerations… CHA continues to be concerned about the narrow definition of 'plume scavenging system'" The narrow definition would not appear to allow a hospital to use, or the regulations to recognize, an engineering control other than one of the listed items to obtain the same result – evacuation of plume. Currently, and certainly as technology develops, some equipment not specifically identified as a "plume scavenging system" could also serve to evacuate plume. We believe the definition is ambiguous and could be construed to require 100 percent evacuation. To address these concerns, we propose the following definition of "plume scavenging system" "means a device for capturing, transporting, and filtering plume and exhausting the filtered product." We request additional clarification on the bill on some conflicting directives."
AB 402 would require the Occupational Safety and Health Standards Board to adopt a regulation that requires a health facility to evacuate or remove smoke plumes routinely generated during certain medical procedures through the use of plume scavenging systems by July 1, 2020.
The creation of new occupational safety and health standards does not require legislation; any member of the public may petition the Standards Board to consider creating a new safety regulation. I agree that the state should evaluate the need for a standard to address the health and safety hazards posed by plume and I suggest that the Author and Sponsor petition the Standards Board to initiate that process.
Analysis Prepared by: Taylor Jackson / L. & E. / 916-319-2091 FN: 0002464
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB |
THIRD READING
Bill No: AB 402
:
SENATE LABOR & IND. REL. COMMITTEE: 3-1, 6/28/17
AYES: Bradford, Atkins, Jackson
NOES: Stone
NO VOTE RECORDED: Mitchell
SENATE APPROPRIATIONS COMMITTEE: 5-2, 9/1/17
AYES: Lara, Beall, Bradford, Hill, Wiener
NOES: Bates, Nielsen
ASSEMBLY FLOOR: 55-21, 5/30/17 - See last page for vote
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”.
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 Cal/OSHA, by June 1, 2018, to form an advisory committee to develop and submit to the Board by June 1, 2019, 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.
- 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 “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.
- 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.
- 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.
- 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.
- Requires that by July 1, 2020, the Board must adopt the proposed regulation.
- States that its provisions do not alter or affect general room ventilation standards in any way.
- Stipulates that the use of surgical masks do not qualify as protection against plume.
- 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.
- 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 this bill.
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 (DIR) indicates that costs associated with the 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 Cal/OSHA would incur unknown enforcement costs once the standards have been developed.
California Nurses Association (co-source)
National Nurses United (co-source)
American Lung Association – California
Board of Registered Nursing
California Labor Federation, AFL-CIO
OPPOSITION: (Verified 8/31/17)
California Hospital Association
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 (CHA) opposes this bill unless amended and argues, "The hospital, together with the surgical team, selects devices that may generate plume as well as devices that could minimize exposure to plume because of patient care considerations… CHA continues to be concerned about the narrow definition of 'plume scavenging system'" CHA believes that the narrow definition would not appear to allow a hospital to use, or the regulations to recognize, an engineering control other than one of the listed items to obtain the same result which is the evacuation of plume.
CHA contends that currently, and certainly as technology develops, some equipment not specifically identified as a "plume scavenging system" could also serve to evacuate plume. CHA believes the definition is ambiguous and could be construed to require 100 percent evacuation. To address these concerns, CHA proposes the following definition of "plume scavenging system" as "a device for capturing, transporting, and filtering plume and exhausting the filtered product." Finally, CHA requests additional clarifications on this bill regarding what they believe are conflicting directives in developing the regulation.
ASSEMBLY FLOOR: 55-21, 5/30/17
AYES: Aguiar-Curry, Arambula, Berman, Bloom, Bocanegra, Bonta, Burke, Caballero, Calderon, Cervantes, Chiu, Chu, Cooley, Cooper, Cunningham, Dababneh, Daly, Flora, Frazier, Friedman, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gomez, Gonzalez Fletcher, Gray, Grayson, Holden, Irwin, Jones-Sawyer, Kalra, Levine, Limón, Low, McCarty, Medina, Mullin, Muratsuchi, Nazarian, O'Donnell, Quirk, Quirk-Silva, Reyes, Ridley-Thomas, Rodriguez, Rubio, Salas, Santiago, Mark Stone, Thurmond, Ting, Weber, Wood, Rendon
NOES: Acosta, Baker, Bigelow, Brough, Chávez, Chen, Dahle, Fong, Gallagher, Harper, Kiley, Lackey, Maienschein, Mathis, Mayes, Melendez, Obernolte, Patterson, Steinorth, Voepel, Waldron
NO VOTE RECORDED: Travis Allen, Chau, Choi, Eggman
9/4/17 13:02:54
**** END ****
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2017 - 2018 Regular Session
AB 402 (Thurmond) - Occupational safety and health standards: plume
Version: February 9, 2017 | Policy Vote: L. & I.R. 3 - 1 |
Urgency: No | Mandate: Yes |
Hearing Date: July 10, 2017 | Consultant: Robert Ingenito |
This bill meets the criteria for referral to the Suspense File.
Bill Summary:
AB 402 would require 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.”
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 DOSH, by June 1, 2018, to convene an advisory committee to develop a regulation requiring a health facility to evacuate or remove plume through the use of a plume scavenging system in relevant settings. DOSH must submit to the Board a proposed regulation by June 1, 2019, and the Board must adopt a proposed regulation by July 1, 2020.
- Require DOSH, in developing regulations, to consider and evaluate standards developed by the International Organization for Standardizing (ISO) and to consider recommendations from the federal Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH).
- Mandate that regulations include a requirement that employers provide training to workers participating in plume-creating procedures. This training must include general education on the contents of plume, its health and safety hazards, how it is generated, and how it can be managed through the use of plume scavenging equipment.
- Define "plume scavenging system" as 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.
- State that the use of surgical masks will not satisfy the requirements of the bill, and neither will respirators, except as specified.
Related Legislation: AB 2272 (Thurmond, 2016) was nearly identical to this bill. The bill was vetoed by the Governor.
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 Steven Bradford, Chair
2017 - 2018 Regular
Bill No: AB 402 Hearing Date: June 28, 2017
Author: | Thurmond | ||
Version: | February 9, 2017 | ||
Urgency: | No | Fiscal: | Yes |
Consultant: | Brandon Seto | ||
Subject: Occupational safety and health standards: plume
KEY ISSUE
Should the Legislature require 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”?
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 Cal/OSHA, by June 1, 2018 to form an advisory committee to develop and submit to the Board by June 1, 2019, 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.
- 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 “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.
- 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.
- 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.
- 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.
- Requires that by July 1, 2020, the Board must adopt the proposed regulation.
- States that its provisions do not alter or affect general room ventilation standards in any way.
- Stipulates that the use of surgical masks do not qualify as protection against plume.
- 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.
- 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
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 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.
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 (CHA) opposes this measure unless amended and argues, "The hospital, together with the surgical team, selects devices that may generate plume as well as devices that could minimize exposure to plume because of patient care considerations… CHA continues to be concerned about the narrow definition of 'plume scavenging system'" CHA believes that the narrow definition would not appear to allow a hospital to use, or the regulations to recognize, an engineering control other than one of the listed items to obtain the same result which is the evacuation of plume.
CHA contends that currently, and certainly as technology develops, some equipment not specifically identified as a "plume scavenging system" could also serve to evacuate plume. CHA believes the definition is ambiguous and could be construed to require 100 percent evacuation. To address these concerns, CHA proposes the following definition of "plume scavenging system" as "a device for capturing, transporting, and filtering plume and exhausting the filtered product." Finally, CHA requests additional clarifications on the bill regarding what they believe are conflicting directives in developing the regulation.
4. Prior Legislation:
AB 2272 (Thurmond) Vetoed, 2016 was nearly identical to this bill.
Governor Brown’s Veto Message:
“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.”
SUPPORT
California Nurses Association (Co-Sponsor)
National Nurses United (Co-Sponsor)
American Lung Association – California
Board of Registered Nursing
California Labor Federation, AFL-CIO
OPPOSITION
California Hospital Association
-- END --
ASSEMBLY THIRD READING
ATR Bill Id:AB 402
Author:(Thurmond)
As Introduced Ver:February 9, 2017
Majority vote
Committee | Votes | Ayes | Noes |
Labor | 6-1 | Thurmond, Flora, Gomez, Kalra, McCarty, Reyes | Harper |
Appropriations | 12-5 | Gonzalez Fletcher, Bloom, Bocanegra, Bonta, Calderon, Chau, Eggman, Friedman, Eduardo Garcia, Gray, Muratsuchi, Reyes | Bigelow, Brough, Fong, Gallagher, Obernolte |
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:
- Requires the Division of Occupational Safety and Health (Division) by June 1, 2018, to convene an advisory committee to develop a regulation, 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.
- Requires the division by June 1, 2019, to submit to the board a proposed regulation.
- Requires the board by July 1, 2020, to adopt a proposed regulation.
- Specifies 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 in this bill.
- Requires the division, in developing proposed regulations to do certain things, including evaluating the use of certain standards and recommendations adopted by specified organizations as a benchmark.
- Specifies that nothing in this section alters, amends, expands, or reduces existing general room ventilation standards or requirements and compliance with general room ventilation standards shall not satisfy the requirements of this section.
- States the use of surgical masks shall not satisfy the requirements of this section and that the use of respirators shall not satisfy the requirements of this section except as specified.
- Requires 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 manufacturer’s instructions.
- Mandates that a requirement is included in the regulation for employers to provide training to all workers foreseeably participating in procedures that involve the creation of plume. Specifies what the training shall include, but not be limited to.
- Defines "plume scavenging system" as 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.
- Defines various other terms for purposes of this section.
FISCAL EFFECT: According to the Assembly Appropriations Committee, minor and absorbable costs for the Division and the Board to develop regulations and unknown but likely minor enforcement costs to the Division once the bill is implemented.
COMMENTS: According to the author, 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. 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.
Arguments in Support
The California Labor Federation is in support of this measure and argues, "Surgical plume is also known to contain mutagenic (cancer producing) particles. One study equated the mutagenic condensate generated from one gram of tissue to three cigarettes from lasers and six cigarettes for electrocautery smoke. At high concentrations, exposure to plume is also known to cause ocular and upper respiratory tract irritation in health care personnel. The risks associated with surgical plume, unfortunately, are not eliminated by general room ventilation or the use of surgical masks. Instead, it requires the use of local exhaust ventilation placed close to the site where the smoke is generated. This bill will require the Cal/OSHA Standards Board to adopt regulations better protecting workers from this incredibly dangerous hazard. The bill includes specific language to guide and streamline the regulatory process and will, if enacted, prevent many catastrophic illnesses from occurring to affected employees."
Arguments in Opposition
The California Hospital Association opposes this measure unless amended and argues, "The hospital, together with the surgical team, selects devices that may generate plume as well as devices that could minimize exposure to plume because of patient care considerations… CHA continues to be concerned about the narrow definition of 'plume scavenging system'" The narrow definition would not appear to allow a hospital to use, or the regulations to recognize, an engineering control other than one of the listed items to obtain the same result — evacuation of plume. Currently, and certainly as technology develops, some equipment not specifically identified as a "plume scavenging system" could also serve to evacuate plume. We believe the definition is ambiguous and could be construed to require 100 percent evacuation. To address these concerns, we propose the following definition of "plume scavenging system" "means a device for capturing, transporting, and filtering plume and exhausting the filtered product." We request additional clarification on the bill on some conflicting directives."
Analysis Prepared by: Taylor Jackson / L. & E. / 916-319-2091 FN: 0000081
Date of Hearing: April 5, 2017
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez Fletcher, Chair
ABPCA Bill Id:AB 402
Author:(Thurmond) – As Introduced Ver:February 9, 2017
Policy Committee: | Labor and Employment | Vote: | 6 - 1 |
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 generated during specified medical procedures, otherwise known as “plume.” In summary, this bill:
- Requires the Division of Occupational Safety and Health (Division), by June 1, 2018, to convene an advisory committee to develop a regulation requiring a health facility to evacuate or remove plume through the use of a plume scavenging system in relevant settings. The Division must submit to the Board a proposed regulation by June 1, 2019, and the Board must adopt a proposed regulation by July 1, 2020.
- Requires the Division, in developing regulations, to consider and evaluate standards developed by the International Organization for Standardizing (ISO) and to consider recommendations from the federal Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH).
- Mandates that regulations include a requirement that employers provide training to workers participating in plume-creating procedures. This training must include general education on the contents of plume, its health and safety hazards, how it is generated, and how it can be managed through the use of plume scavenging equipment.
- Defines "plume scavenging system" as 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.
- States that the use of surgical masks will not satisfy the requirements of the bill, and neither will respirators except as specified.
FISCAL EFFECT:
- Minor and absorbable costs for the Division and the Board to develop regulations.
- Unknown but likely minor enforcement costs to the Division once the bill is implemented.
COMMENTS:
- Background and purpose. Surgical plume is a smoke product generated from the thermal destruction of skin tissue during certain surgical procedures. 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 exists.
According to supporters of AB 402, medical employees are at significantly higher risk of severe persistent asthma or other health issues as a result of occupational exposure to surgical plume smoke. This bill aims to curtail that risk through the development of state regulations.
- Existing standards and recommendations. Existing federal law allows OSHA to cite hospitals for not making an effort to control surgical plume. However, supporters of this bill argue that OSHA, in practice, has a limited ability to eliminate unsafe practices involving surgical plume.
While no other state has specific workplace regulations around surgical plume, government agencies and nongovernmental organizations have published recommendations and standards that can be used as a benchmark. In addition to OSHA’s recommendations, ISO and NIOSH have also published standards and recommendations.
- Support and opposition. AB 402 is supported by the California Nurses Association/ National Nurses Association (sponsor), the California Labor Federation, and the American Lung Association in California.
The California Hospital Association opposes the bill in part because of the restrictive definition of “plume scavenging system,” which could disallow other potential effective strategies to evacuate plume.
- Veto of similar legislation. AB 2272 (Thurmond), in 2016, was substantially similar to this bill. It was vetoed by the Governor, whose vetoed message stated:
“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: Luke Reidenbach / APPR. / 916 319-2081
Date of Hearing: March 15, 2017
ASSEMBLY COMMITTEE ON LABOR AND EMPLOYMENT
Tony Thurmond, Chair
ABPCA Bill Id:AB 402 (
Author:Thurmond) – As Introduced Ver:February 9, 2017
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:
- Requires the Division of Occupational Safety and Health (Division) by June 1, 2018 to convene an advisory committee to develop a regulation, 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.
- Authorizes certain entities and people to be on the advisory committee, including, among others, practicing physicians and surgeons from affected specialties.
- Requires the division by June 1, 2019, to submit to the board a proposed regulation.
- Requires the board by July 1, 2020, to adopt a proposed regulation.
- Specifies 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 in this bill.
- Requires the division, in developing proposed regulations to do certain things, including evaluating the use of certain standards and recommendations adopted by specified organizations as a benchmark.
- Specifies that nothing in this section alters, amends, expands, or reduces existing general room ventilation standards or requirements and compliance with general room ventilation standards shall not satisfy the requirements of this section.
- States the use of surgical masks shall not satisfy the requirements of this section.
- States the use of respirators shall not satisfy the requirements of this section except as specified in this section due to medical necessity.
- Requires 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 manufacturer’s instructions.
- Mandates that a requirement is included in the regulation for employers to provide training to all workers foreseeably participating in procedures that involve the creation of plume. Specifies that the training shall include, but not be limited to, general education on the contents of plume, the circumstances in which it is generated, the associated health and safety hazards, and appropriate use of the plume scavenging equipment and systems utilized by the health facility. Provides that the training shall be designed to provide an opportunity for interactive questions and answers with a person knowledgeable about occupational exposure to plume and the specific equipment utilized to scavenge plume.
- 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.
- Defines "plume scavenging system" as 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.
- Defines various other terms for purposes of this section.
EXISTING LAW:
- Establishes the Occupational Safety and Health Standards Board under the Division of Occupational Safety and Health, 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.
- Provides for DIR to implement laws passed by the California Legislature and signed by the Governor.
- Authorizes DIR in the process of implementing laws, to create and adopt regulations in a rulemaking process, which the public participates in.
- Specifies that once regulations have been adopted within the DIR, they must be approved by the Office of Administrative Law and filed with the Secretary of State.
FISCAL EFFECT: Unknown
COMMENTS: According to the author, 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. 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 were 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.”[1]
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 California Nurses Association/National Nurses United is the sponsor of this measure and states, “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 has 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.”
The California Labor Federation is in support of this measure and argues, “Surgical plume is also known to contain mutagenic (cancer producing) particles. One study equated the mutagenic condensate generated from one gram of tissue to three cigarettes from lasers and six cigarettes for electrocautery smoke. At high concentrations, exposure to plume is also known to cause ocular and upper respiratory tract irritation in health care personnel. The risks associated with surgical plume, unfortunately, are not eliminated by general room ventilation or the use of surgical masks. Instead, it requires the use of local exhaust ventilation placed close to the site where the smoke is generated. This bill will require the Cal/OSHA Standards Board to adopt regulations better protecting workers from this incredibly dangerous hazard. The bill includes specific language to guide and streamline the regulatory process and will, if enacted, prevent many catastrophic illnesses from occurring to affected employees.”
ARGUMENTS IN OPPOSITION
The California Hospital Association opposes this measure unless amended and argues, “The hospital, together with the surgical team, selects devices that may generate plume as well as devices that could minimize exposure to plume because of patient care considerations. The hospital’s ability to impact decisions made by physicians in the operating room may be limited, and could interfere with patient care. CHA continues to be concerned about the narrow definition of “plume scavenging system.” The narrow definition would not appear to allow a hospital to use, or the regulations to recognize, an engineering control other than one of the listed items to obtain the same result—evacuation of plume. Currently, and certainly as technology develops, some equipment not specifically identified as a “plume scavenging system” could also serve to evacuate plume. We believe the definition is ambiguous and could be construed to require 100 percent evacuation. To address these concerns, we propose the following definition of “plume scavenging system” “means a device for capturing, transporting, and filtering plume and exhausting the filtered product.” We request additional clarification on the bill on some conflicting directives.”
PREVIOUS RELATED LEGISLATION
AB 2272 (Thurmond) from 2016 was substantially similar to this bill. AB 2272 was vetoed by the Governor. The Governor's veto message stated:
“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.”
REGISTERED SUPPORT / OPPOSITION:
Support
American Lung Association in California
California Labor Federation, AFL-CIO
California Nurses Association/ National Nurses United (sponsor)
Opposition
California Hospital Association (oppose unless amended)
Analysis Prepared by: Taylor Jackson / L. & E. / (916) 319-2091
Environment of Care® News, September 2007, Volume 10, Issue 9- Joint Commission on Accreditation of Healthcare Organizations ↑
Discussed in Hearing
Senate Floor
Senate Standing Committee on Appropriations
Senate Standing Committee on Labor and Industrial Relations
Assembly Floor
Assembly Standing Committee on Appropriations
Assembly Standing Committee on Labor and Employment
Bill Author
Bill Co-Author(s):