BILL ANALYSIS Ó
SENATE COMMITTEE ON LABOR AND INDUSTRIAL RELATIONS
Senator Tony Mendoza, Chair
2015 - 2016 Regular
Bill No: AB 2272 Hearing Date: June 22,
2016
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|Author: |Thurmond |
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|Version: |June 14, 2016 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant:|Brandon Seto |
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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
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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
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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
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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
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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
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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
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