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NOTE: These FAQs were drafted in cooperation with the
Centers for Disease Control and Prevention (CDC) and are intended to address
questions about how the provisions of OSHA's Bloodborne Pathogens Standard
(29 CFR 1910.1030) apply to healthcare workers who administer smallpox
vaccinations during the current vaccination program. For more information on
smallpox vaccinations, visit www.cdc.gov.
What is the Bloodborne Pathogen Standard?
OSHA's Bloodborne Pathogens Standard, 29 CFR 1910.1030
as amended pursuant to the 2000 Needlestick Safety and Prevention Act, is a
regulation that prescribes safeguards to protect workers against health
hazards related to bloodborne pathogens. It has provisions dealing with
exposure control plans, engineering and work practice controls, hepatitis B
vaccination, hazard communication and training, and recordkeeping. The
standard imposes requirements on employers of workers who may be exposed to
blood or other potentially infectious materials such as certain tissues and
bodily fluids.
Are workers who administer the smallpox vaccine covered by
the Bloodborne Pathogens Standard?
Federal OSHA authority extends to all private sector
employers, as well as to federal entities employing civilians. State and
local government employers are only subject to the Occupational Safety and
Health Act if they are in one of the 26 states and territories that have
opted to develop and operate their own OSHA-approved job safety and health
programs. In the remaining states, these governmental employers are not
required to comply with OSHA standards.
The Bloodborne Pathogens Standard is fully consistent
with relevant CDC guidelines, and many state and local government healthcare
employers comply with those guidelines. CDC recommends that all smallpox
vaccination clinics comply with the Standard's provisions.
What are employers involved in smallpox immunization
efforts required to do to comply with the standard?
Because these employers should already be complying with
the standard, only a few additional precautions will be necessary, including
updating their exposure control plans so that they address smallpox
vaccination, and providing their employees with vaccination procedure-specific
training.
As of January, 2003, CDC has determined that no
commercially available safety-engineered bifurcated needle is an appropriate
replacement for the bifurcated needle that is included in the pre-packaged
kit that is being distributed for administering smallpox vaccine in this
national program. If, in the future, improved safety devices become
commercially available, the standard requires employers, as part of any
exposure control plan modification, to evaluate whether any of those devices,
including sharps with engineered sharps injury protections (SESIPs), may be
appropriate for the work practices of their employees.
The exposure control plan
The Bloodborne Pathogens Standard requires employers to
review and update their exposure control plans at least annually or whenever
necessary to reflect new or modified tasks or procedures affecting employee
exposure. Facilities involved in the smallpox immunization plan will need to
ensure that their plans include provisions relevant to the administration of
smallpox vaccine.
Existing plans should already include the following
elements:
1. Exposure determinations defining which job
classifications have occupational exposure. In this instance it is
individuals who perform vaccination and/or handle sharps disposal containers,
as well as individuals who perform follow-up care for people who have been
vaccinated.
2. Engineering and work practice controls, e.g.,
appropriate medical devices, sharps disposal containers, hand hygiene.
3. Personal protective equipment.
4. Housekeeping, including decontamination procedures
and removal of regulated waste.
5. Information and training, including training
associated with the performance of new tasks or procedures (see below).
6. Hepatitis B vaccination.
7. Post-exposure evaluation and follow-up.
8. Recordkeeping (including sharps injury log).
Aspects of the exposure
control plan that may need special attention relevant to the smallpox
vaccination program include:
1. Training on the safe use and disposal of bifurcated
needles (see below).
2. Procedures for safe performance of vaccination
including:
a. Ensure that vaccination supplies, including sharps
containers, are conveniently located at the point of vaccination.
b. Prior to performing vaccination, explain the
procedure to the vaccinee, including the risk of sharps injury to the
vaccinator, and the need to avoid inadvertent movement during the procedure.
c. Maintain visual contact with the bifurcated needle
until vaccination is completed and the needle disposed.
d. Immediately dispose of the bifurcated needle in the
point-of-use sharps container. (If bifurcated needles must be reprocessed,
safety measure to prevent injury after use and during reprocessing should be
followed.)
e. If a bifurcated needle drops, pick it up carefully
in such a way as to minimize the possibility of accidental needlestick,
preferably through the use of forceps or other methods that reduce the chance
of accidental needlestick. In no event should an employee touch the sharp end
of the needle.
f. Dispose of vaccine vials and blood-contaminated
gauze in the appropriate waste containers in accordance with applicable
state, county, municipal regulations.
3. Procedures for reporting and follow-up management of
blood exposures at vaccination clinics. If the creation of vaccination
clinics will alter the employer's existing procedure for exposure reporting
and medical evaluation and treatment, then this aspect of the exposure
control plan will need to be amended.
If these steps are
followed diligently, the opportunity for blood exposure and sharps injury
should be minimal.
Safer
medical devices
As a primary method of employee protection, the Standard
requires employers to eliminate or minimize employee exposure to blood and
other potentially infectious materials, to consider using appropriate
commercially available and effective safer medical devices such as SESIPs to
meet this obligation, and to document that consideration whenever they update
their exposure control plans. Only one medical device incorporating the
bifurcated needle design is part of the prepackaged kit for the licensed
Dryvax smallpox vaccine. As of January 2003, CDC has determined that no other
commercially available bifurcated needles are appropriate for administering
the smallpox vaccine being distributed in this prepackaged kit. If, in the
future, improved safety devices become commercially available, employers will
be responsible for evaluating whether any of those devices are appropriate
for use at their workplaces.
Training
The Bloodborne Pathogens Standard also requires
employers to provide training to each worker in any new tasks or procedures
that affect the employee's occupational exposure. Administration of the
smallpox vaccine would be such a new task or procedure for most workers. The
materials provided by the vaccine manufacturer and the training provided by
CDC provides the foundation for meeting this requirement.
Other provisions
Other OSHA requirements are applicable to workers
administering the smallpox vaccine, including additional provisions of the
Bloodborne Pathogens Standard, as well as the Hazard Communication Standard,
and recordkeeping, record retention, and record access rules. For example,
workers administering vaccine must be offered hepatitis B vaccination and
appropriate follow-up, and an employer's obligations if an employee sustains
a needlestick injury during vaccine administration would be the same as they
would for any other needlestick injury. Health care employers are already
required to comply with those requirements, however, so no new obligations
would be imposed because of the smallpox vaccination program.
For more information about how OSHA's Occupational
Exposure to Bloodborne Pathogens Standard (29 CFR 1910.1030) applies to
healthcare workers who administer smallpox vaccinations, please contact your
local OSHA office, or the Office of Health Enforcement Programs at (202)
693-2190.
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