Biomedical Engineering Reference
In-Depth Information
The term “shall” means that material is mandatory for
compliance. Only normative material found up to but not
including tables and appendices contains “shalls.”
Where there is a “NOTE:” following a normative statement,
the material is intended as further explanation or support, but
it cannot contain “shalls.”
Though ANSI standards have no offi ce of compliance, nor
enforcement capabilities, its contents parallel the requirements
found in OSHA regulations for workplace safety. Further, the
fact that the USA has a national standard defi ning the risks
and hazards of HCLS, it is appropriate to classify these known
hazards as workplace safety issues, and therefore, OSHA law
can be used as the basis for mandatory compliance with ANSI.
OSHA applies the General Duty Clause as the mechanism
for citing facilities for noncompliance. The General Duty
Clause places a duty of care on both employee and employer.
The law requires employers to provide their employees with a
workplace free of known hazards, to ensure appropriate edu-
cation and training relative to workplace hazards, and to man-
date the use of personnel protective equipment and work
practices that mitigate exposure to those hazards.
OSHA requires the elimination or control of exposure to
known hazards in the workplace. In terms of laser safety, these
known hazards may include but are not limited to possible
ocular exposure and injury, fl ammability and refl ectivity haz-
ards, exposure to airborne contaminants in surgical plume,
inadvertent exposure to the beam, and electrical hazards.
OSHA and TJC both use the ANSI standards as the basis
for their regulations and guidance, so ensuring compliance
with these regulations depends on knowledge of the ANSI
standards.
The reason for OSHA to use the ANSI Standard comes from
its defi nition of standard:
persons that may be present in the laser treat-
ment room, to work safely with HCLS.
2. Equipment maintenance
a) The user is responsible for ensuring that all
equipment is kept in proper working order; can
produce documentation that validates a history
of service and maintenance; and meets all federal,
state, and local registrations and regulations.
3. A safety program is to be implemented and enforced.
a) A laser safety program contains requirements for
management and employee involvement, com-
pliance with all standards and regulations, educa-
tion, audit, and quality assurance. The laser safety
plan can be incorporated into a facility safety
plan, but it must contain the specifi c hazards and
control measures associated with HCLS.
If a laser safety program investigation is conducted by
OH&S, the focus will be on reviewing administrative control
measures, documentation, and interviewing personnel to
assess their level of knowledge. By looking at the process of
safety management, a compliance offi cer can assess whether or
not a facility has demonstrated that they have done the
following:
1. Established written safety policies and procedures.
2. Identifi ed criteria for selection of protective equip-
ment.
3. Implemented adequate education and training pro-
grams for all employees who may be exposed to the
hazards.
4. Performed and documented periodic safety audits.
OH&S should be viewed as an advocate for safe practice, and
can offer education, assistance, advice, and resources to help
the individual practice comply with standards and regulations.
It is to everyone's benefi t, especially the patient's, for laser users
to take advantage of these resources during the early phases of
program planning, and well ahead of treating the fi rst patient,
or making the decision to purchase or rent laser equipment.
Many healthcare facilities, including ambulatory surgery
centers and private practices, are accredited by, or have applied
to be accredited by one of the national accreditation organiza-
tions such as TJC or the Accreditation Association for Ambu-
latory Health Care. This credential is given when a healthcare
organization undergoes rigorous preparation, and then passes
an extensive on-site survey based on demonstrating compli-
ance with its standards, as applied to its physical plant, admin-
istration, and clinical practices. Accreditation enables the
institution to prove a level of excellence in every aspect of its
services to the community.
Evidence of the requirement for establishing a formal laser
safety plan, can be found in TJC standards, Environment of
Care 02.02.01: The hospital manages risks related to hazardous
materials and waste (3). The hospital minimizes risks associ-
ated with selecting, and using hazardous energy sources…
including but not limited to ionizing and non-ionizing radia-
tion equipment and lasers. Surveyors will require the facility to
demonstrate compliance through audit reports, and appropri-
ate documentation of administrative controls.
1910.2(f): “Standard” requires conditions, or the
adoption or use of one or more practices, means,
methods, operations, or processes, reasonably neces-
sary or appropriate to provide safe or healthful
employment and places of employment.
●
1910.2(g) “National consensus standard” means any
standard or modifi cation thereof, which (1) has been
adopted and promulgated by a nationally recognized
standards-developing organization under proce-
dures whereby it can be determined by the Secretary
of Labor or by the Assistant Secretary of Labor
that persons interested and affected by the scope or
provisions of the standard have reached substantial
agreement on its adoption, (2) was formulated in a
manner which afforded an opportunity for diverse
views to be considered.
●
Both OSHA and ANSI require these:
1. Education and training for all personnel.
a) Education is noncommercial, didactic knowl-
edge, presented at a professional level, and is
validated by exam or other mechanism for mea-
surement of acquired knowledge. Training is
competency based, validated by physical demon-
stration of profi ciency. Both of these are needed
to prepare users, operators, and all ancillary
