OSHA Inspection: A.P.I ANALYTAB DIVISION OF SHERWOOD MEDICAL

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $3,150 · Current $1,575 Reduced

General-duty citation text

Section 5(a)(1) of the Occupational Safety and Health Act of 1970: The
employer did not furnish employment and a place of employment whch were
free from recognized hazards that were causing or were likely to cause
death or serious physical harm to employees in that employees were
exposed to the hazards of becoming infected with bacterial agents
through possible direct contact, ingestion, or parenteral inoculation
with active cultures:
(a)  In the Laboratories - Laboratory employees that
perform tasks such as, but not limited to, plating
and streaking agar plates with bacterial agents in
the New Product Development, Microbiology and Quality
Control laboratories, are working with and exposed
to Biosafety Level 2 bacterial agents without the
employer implementing and enforcing effective Biosafety
Level 2 practices, containment equipment and facilities
and Biosafety Level 3 primary containment and personnel
precautions for activities that may produce aerosols or
droplets of bacterial agents, or activities involving
concentrated bacterial cultures; on or about 4/21/92.
The hazards of such exposure include, but are not limited to bacterial
infections.
Feasible abatement methods to correct this hazard as stipulated in the
Centers for Disease Control Guidelines published in Biosafety in Micro-
biology and Biomedical Laboratories, HHS Publication Number (NIH) 88-
8395, include, but are not limited to:
BIOSAFETY LEVEL 2 STANDARD MICROBIOLOGICAL PRACTICES
1.   Access to the laboratory is limited to or restricted by the
laboratory director when work with  infectious agents is in
progress.
2.   Work surfaces are decontaminatd at least once a day and after
any spill of viable material.
3.   All infectious liquid or solid wastes are of contaminated
before disposal.
4.   Mechanical pipetting devices are used; mouth pipetting is
prohibited.
5.   Eating, drinking, smoking, and applying cosmetics are not
permitted in the work area.  Food may be stored in cabinets
or refrigerators designated and used for this purpose only.
Food storage cabinets or refrigerators should be located
outside of the work area.
6.   Persons wash their hands after handling infectious materials
and when they leave the laboratory.
7.   All procedures are performed carefully to minimize the crea-
tion of aerosols.
BIOSAFETY LEVEL 2 SPECIAL PRACTICES
1.   Contaminated materials that are to be decontamnated at a
site away from the laboratory are placed in a durable
leakproof container which is closed before being removed
from the laboratory.
2.   The laboratory director limits access to the laboratory.  In
general, persons who are at increased risk of acquiring
infection or for whom  infection may be unusually hazardous
are not allowed in the laboratory.  The director has the
final responsibility for assessing each circumstance and
determining who may enter or work in the laboratory.
3.   The laboratory director establishes policies and procedures
whereby only persons who have been advised of the potential
hazard and meet any specific entry requirements (e.g.
immunization) enter the laboratory.
4.   When infectious agents in use in the laboratory require
special provisions for entry (e.g. vaccination), a hazard
warning sign, incorporating the universal biohazard symbol,
is posted on the access door to the laboratory work area.
The hazard warning sign identifies the infectious agent,
lists the name and telephone number of the laboratory
director or other responsible person(s), and indicates
the special reqirements for entering the laboratory.
5.   An insect and rodent control program is in effect.
6.   Laboratory coats, gowns, smocks, or uniforms are worn while
in the laboratory.  Before leaving the laboratory for non-
laboratory areas (e.g., cafeteria, library, administrative
office), this protective clothing is removed and left in
the laboratory or covered with a clean coat not used in
the laboratory.
7.   Special care is taken to avoid skin contamination with
infectious materials; gloves should be worn when skin
contact with infectious materials is unavoidable.
8.   All wastes from laboratories are appropriately decontaminated
before disposal.
9.   Hypodermic needles and syringes are used only for parenteral
injection and aspiration of fluids from diaphragm bottles.
Only needle-locking syringes or disposable syringes-needle
units (i.e., needle is integral to the syringe) are used for
the injection or aspiration of infectious fluids.  Extreme
caution should be used when handling needles and syringes to
avoid autoinoculation and the generation of aerosols during use
and disposal.  Needles should not be bent, sheared, replaced
in the sheath or guarded or removed from the syringe
following use.  The needle and syringe should be promptly
placed in a puncture resistant container and decontaminated,
preferably by autoclaving, before discarded or reused.
10.  Spills and accidents which result in overt exposures to
infectious materials are immediately reported to the
laboratory director.  Medical evaluation, surveillance,
and treatment are provided as appropriate and written records
are maintained.
11.  When appropriate, considering the agents handled, baseline
serum samples for laboratory and other at-risk personnel
are collected and stored.  Additional serum specimens may
be collected periodically, depending on the agents handled or
the function of the facility.
12.  A biosafety manual is prepared or adopted.  Personnel are
advised of special hazards and are required to read
instructions on practices and procedures and to follow them.
BIOSAFETY LEVEL 2 CONTAINMENT EQUIPMENT
Biological safety cabinets (Class I or II) or other appropri-
ate personal protective or physical containment devices are
used whenever:
1.   Procedures with a high potential for creating infectious
aerosols are conducted.  These may include centrifuging,
grinding, blending, vigorous shaking or mixing, sonic dis-
ruption, and opening containers of infectious materials whose
internal pressures may be different from ambient pressures.
2.   High concentrations or large volumnes of infectious agents
are used.  Such materials may be centrifuged in the open
laboratory if sealed heads or centrifuge safety cups are used
and if they are opened only in a biological safety cabinet.
BIOSAFETY LEVEL 2 LABORATORY FACILITIES
1.   The laboratory is designed so that is can be easly cleaned.
2.   Bench tops are impervious to water and resistant to acids,
alkalis, organic solvents, and moderate heat.
3.   Laboratory furniture is sturdy, and spaces between benches,
cabinets, and equipment are accessible for cleaning.
4.   Each laboratory contains a sink for handwashing.
5.   If the laboratory has windows that open, they are fitted
with fly screens.
6.   An autoclave for decontaminting infectious laboratory wastes
is available.
BIOSAFETY LEVEL 3 CONTAINMENT EQUIPMENT
Biological safety cabinets (Class I, II or III) or other
appropriate combinations of personal protective or physical
containment devices (e.g., special protective clothing,
masks, gloves, respirators, centrifuge safety cups, and
sealed centrifuge rotors) are used for all activities with
infectious materials which pose a threat of aerosol exposure.
These include:  manipulation of cultures and of those clin-
ical or environmental materials which may be a source of
infectious aerosols.

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $2,250 · Current $1,125 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $2,250 · Current $1,125 Reduced

Issued

Sep 9, 1992

Abate by

Sep 17, 1992

Penalty

Initial $1,800 · Current $900 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1993

Penalty

Initial $3,150 · Current $1,575 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $1,800 · Current $900 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $1,800 · Current $900 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $1,800 · Current $900 Reduced

Issued

Sep 9, 1992

Abate by

Sep 28, 1992

Penalty

Initial $2,250 · Current $1,125 Reduced

Issued

Sep 9, 1992

Abate by

Sep 28, 1992

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $3,150 · Current $1,575 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $3,150 · Current $1,575 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $1,800 · Current $900 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $3,150 · Current $1,575 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $3,150 · Current $1,575 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $3,150 · Current $1,575 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $3,150 · Current $1,575 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $3,150 · Current $1,575 Reduced

Issued

Sep 9, 1992

Abate by

Oct 12, 1992

Penalty

Initial $3,150 · Current $1,575 Reduced

Issued

Sep 9, 1992

Abate by

Sep 22, 1992

Issued

Sep 9, 1992

Abate by

Sep 22, 1992

Issued

Sep 9, 1992

Abate by

Sep 22, 1992

Issued

Sep 9, 1992

Abate by

Oct 12, 1992