OSHA Inspection: SHEBOYGAN VETERINARY CLINIC

Issued

Oct 17, 2003

Abate by

Nov 19, 2003

Penalty

Initial $1,500 · Current $1,050 Reduced

General-duty citation text

Section 5(a)(1) of the Occupational Safety and Health Act of 1970:  The
employer did not
furnish employmnent and a place of employment which were free from
recognized hazards that
were causing or likely to cause death or serious physical harm to
employees in that employees
were exposed to Cytotoxic Antineoplastic Drugs (CD's), including
doxorubicin hydrochloride,
methotrexate, vincristine sulphate and lyophilized cytoxan through
airborne and surface
contamination of the practice.
These CD's were formulated in multiple locations in the practice by the
employer and applied
to animal patients without the use of  protective engineering controls,
safe work practices,
adequate PPE, training and decontamination procedures.  The employer
reconstituted these drugs
by injecting the diluent into the receiving vial using a large bore needle
to equalize pressure
without enclosure in a cytotoxic laminar flow cabinet as recommended by
the drug manufacturer.
The use of a needle pressure equalizer has been documented to create
airborne
contamination
by CD's ejected from the port during this process.   IV tubing used for
delivery to the animal
patient was primed outside of an enclosure, additionally contaminating the
air and various
surfaces in each of these locations.   No decontamination procedures were
in effect.
:
a)On or about 05/01/03, employees worked in the same areas where CD's were
reconstituted, assisted in the application CD solutions to animal patients
and were
expected to assist with cleanup of vomit or excreta of CD treated animals
in the clinic
area.  Exposure to these drugs may cause organ damage, may impair
fertility, may be
carcinogenic, mutagenic and teratogenic, and may cause reproductive
effects.   Exposures
to various doses of these drugs can be cumulative.
Among other methods, one feasible and acceptable abatement method to
correct this
hazard is to develop and implement a Hazardous Drugs Safety and Health
Plan that
follows the guidelines established by the American Society of Hospital
Pharmacist
(ASHP), 1990, ASHP Technical Assistance Bulletin on Handling Cytotoxic and
Hazardous Drugs, or the OSHA Technical Manual (TED 1:15) Section V:
Chapter 2,
Controlling Occupational Exposure to Hazardous Drugs.
These guidelines include at minimum the following elements:
1.)Standard operating procedures relevant to safety and health
considerations to be
followed when workers are using or exposed to hazardous drugs. These
standard
operating procedures should assure that CD contaminated sharps should be
disposed of immediately following usage in a properly labeled and safe
sharps
container without recapping.
2.)Criteria that the employer uses to determine and implement control
measures to
reduce employee exposure to hazardous drugs including engineering
controls, the
use of protective equipment, and hygiene practices.  This would include a
Respiratory Protection Program which complies with 29 CFR 1910.134, the
provision of NIOSH approved respirators of at least N100 level, and
evaluation
of other protective equipment needs wherever formulations are mixed
outside a
laminar flow hood or Biological Safety Cabinet (BSC),3.)Provisions for
safety and health training;
4.)Provisions for medical examinations for potentially exposed personnel;
5.)Designation of personnel responsible for implementation of the
Hazardous Drugs
Safety and Health Plan;
6.)Establishment of a designated Hazardous Drugs handling area,  where
there is
posting of procedures, work practice controls, decontamination procedures
and
spill controls to reduce potential for airborne dissemination;
7.)Use of containment devices such as Biological Safety cabinets where
appropriate,
or other controls to reduce airborne generation of CD's;
8.)Procedures for the labeling and safe removal of contaminated waste;
and
9.)Procedures for decontamination, including clearance monitoring.
Abatement Certification and Abatement Documentation required.

Issued

Oct 17, 2003

Abate by

Oct 21, 2003

Penalty

Initial $600 · Current $420 Reduced

Issued

Oct 17, 2003

Abate by

Oct 21, 2003

Penalty

Initial $600 · Current $320 Reduced

Issued

Oct 17, 2003

Abate by

Nov 19, 2003

Penalty

Initial $750 · Current $625 Reduced

Issued

Oct 17, 2003

Abate by

Oct 21, 2003

Issued

Oct 17, 2003

Abate by

Oct 21, 2003