The laboratory director shall establish a Safety and
Sanitation Manual. This manual shall be consistently implemented throughout the
facility and contain signed or initialed documentation that it has been
reviewed by the director at least annually to ensure that the requirements of
this Part are met. The manual shall include but need not be limited to the
following items as they apply to the licensed or permitted laboratory.
a) General Sanitation and Safety with respect
to:
1) minimum clearance in passageways to
assure that exit from and access to the laboratory is not impeded;
2) the selection of and the schedule for the
use of cleaning supplies for floors, walls, ceilings, bench tops, and
sinks;
3) hand washing
protocol;
4) requiring that all
items which are disposed of and which can cut or puncture the skin shall be
placed in containers which are impervious to the flow of liquids, rigid to
prevent the container from collapsing when handled in the laboratory, and
puncture proof to prevent needles from penetrating the container;
5) safe storage, transport, and use of
compressed gases, if any, which includes the requirements that each cylinder is
shipped with a valve safety cover which shall remain in place when regulators
are not attached; that gas cylinders shall be secured at all times; and that
empty containers shall be labeled and removed from the laboratory;
6) requiring that smoking, eating, and
drinking shall be prohibited in all areas where laboratory work is
performed;
7) requiring that mouth
pipeting shall be prohibited;
8)
requiring that all electrical outlets shall be grounded, electrical equipment
be maintained in condition to prevent shock and fire hazards, and protective
fuses not be bypassed; and
9)
requiring that all blood letting and collection devices shall be both sterile
and disposable.
b)
Warning signs shall indicate "Hazardous Materials" (radioactive, flammable,
poison, irritant, carcinogen, etc.) with required precautions in the use and
storage of those materials.
c) Fire
prevention and control with respect to:
1) the
use of open flames, flammables, safety cans, safety cabinets, etc.;
2) requiring that a fire extinguisher of the
CO2 or dry chemical type shall be in the
laboratory;
3) actions to be taken
in case of fire; and
4) requiring
that provisions for unimpeded egress from the building shall be
posted.
d) Chemical
hazards with respect to:
1) maintenance of a
list of all chemicals used in the laboratory categorized as corrosive,
flammable, toxic, carcinogenic, explosive, radioactive, and
mutagenic;
2) actions to be taken
in the event of an accidental break or spill;
3) ventilation in accordance with the kinds
of chemical fumes encountered;
4)
storage requirements for chemicals which are caustic, poisonous, flammable,
carcinogenic, etc.;
5) requiring
that wastes discharged to any sewer shall be in accordance with the general
requirements for liquids, solids, or gases as well as specific requirements for
mercury and cyanide as established by the Illinois Environmental Protection
Agency (35 Ill. Adm. Code
307).
6)
safe use of radioactive materials, if used in the laboratory, by having a
registration certificate or license from the U.S. Nuclear Regulatory Commission
or the agency to which the U.S. Nuclear Regulatory Commission has delegated
certification or licensure authority.
e) Biological hazards with respect to:
1) handling of specimens to avoid infection
by air, ingestion, direct inoculation, and skin contact;
2) providing biological safety hoods and
other appropriate barriers (i.e. plastic gloves) in accordance with the types
of organisms encountered; and
3)
disposal of cultures, specimens and other potentially infectious materials,
which shall be completely incinerated or otherwise sterilized or sealed in a
container as indicated below to render the materials innocuous before disposal
or removal from the premises.
4)
specific procedures to be followed in the event of accidental exposure to a
biological hazard.
A) The incineration of
materials shall be done in accordance with the requirements of the Illinois
Environmental Protection Agency concerning the operation of an incinerator. (35
Ill. Adm. Code
724).
B) The
sterilization of materials shall be done by autoclaving the materials in
accordance with the manufacturer's recommendations and the effectiveness of the
autoclave shall be verified and documented at least weekly with a biological
spore assay containing B. stearothermophilus.
C) The disposal or removal of materials
outside of the facility shall be done in the following manner:
i) Incinerated or sterilized materials shall
be disposed of through routine waste disposal methods without precautions
against possible contamination.
ii)
Materials which have not been incinerated or sterilized shall be disposed of by
a waste hauler with a proper permit from the Illinois Environmental Protection
Agency. (35 Ill. Adm. Code
809). These materials must be sealed, transported
and stored in biohazard containers. These containers shall be marked
"Biohazard," bear the universal biohazard symbol, and be orange, orange and
black or red. The containers shall be rigid and puncture-resistant such as a
secondary metal or plastic can with a lid that can be opened by a step-on
pedal. These containers shall be lined with one or two high density
polyethylene or polypropylene plastic bags with a total thickness of at least
2.5 mil. or equivalent material. The containers which are marked "Biohazard"
shall be sealed before being removed from the laboratory.