Bloodborne Pathogens Program
7.0 EXPOSURE CONTROL PLAN
7.1 Date
Date of this Exposure Control Plan: November 1998
7.2 Scope
This document is the written Exposure Control Plan for
Northwestern University as required by the OSHA Occupational Exposure
to Bloodborne Pathogens standard.
7.3 Universal Precautions
7.3.1 Definition
Universal precautions is
an approach to infection control in which all human blood and
other potentially infectious materials are treated as if known to be
infectious for HIV, HBV, and other bloodborne pathogens (see appendix
4 for more examples of bloodborne pathogens).
Universal precautions shall be observed to prevent contact
with blood or other potentially infectious materials. When it is difficult
or impossible to differentiate between fluid types, universal precautions
shall be observed.
7.4 Engineering and Work Practice Controls
7.4.1 Definitions
Engineering controls are
controls that isolate or remove the bloodborne pathogens hazard from
the workplace. Examples are sharps containers and self-sheathing needles.
Work practice controls are controls that reduce
the likelihood of exposure by altering the manner in which a task is
performed. If there remains a likelihood of occupational exposure even
when engineering and work practice controls are in place, then personal
protective clothing shall also be used.
7.4.2 Controls to be
Used
7.4.2.1 Handwashing
Readily accessible handwashing facilities shall be provided,
or, if this is not feasible, an appropriate antiseptic hand cleanser and
clean cloth or paper towels. In any case, employees shall wash hands with
soap and running water as soon as feasible after removal of gloves or
other personal protective equipment.
The principal investigator or supervisor shall ensure
that employees wash hands immediately or as soon as feasible after removing
gloves or other personal protective equipment and also shall ensure
that employees wash hands and any other skin with soap and water or
flush mucous membranes with water immediately, or as soon as feasible,
following contact of such body areas with potentially infectious materials.
7.4.2.2 Needles and Sharps
Contaminated needles and other contaminated sharps shall
not be bent, recapped, or removed except as noted below. Shearing or
breaking of contaminated needles is prohibited.
Contaminated needles and sharps shall be recapped or
removed only when no alternative is feasible or when it is required
by a specific medical procedure. Any recapping or removal must be accomplished
through the use of a mechanical device or a one-handed technique. The
recapping or removal of contaminated sharps is actively discouraged
under any circumstances because of the high potential risk of injection.
Immediately after use, contaminated sharps shall be
placed in sharps containers that are puncture-resistant, labeled or
color-coded, and leakproof.
7.4.2.3 Eating, Drinking, Smoking, etc.
Eating, drinking, smoking, applying cosmetics or lip
balm, and handling contact lenses are prohibited in work areas where
there is a reasonable likelihood of occupational exposure. Food and
drink shall not be kept in refrigerators, freezers, shelves, cabinets,
or on countertops or benchtops where blood or other potentially infectious
materials are present.
7.4.2.4 Splashing, Spraying, Spattering
All procedures involving blood or other potentially
infectious materials shall be performed so as to minimize splashing,
spraying, spattering, and generation of droplets.
7.4.2.5 Mouth Pipetting
Mouth pipetting of blood or other potentially infectious
materials is prohibited.
7.4.2.6 Specimen Containers
Specimens of blood or other potentially infectious materials
shall be placed in a container that prevents leakage during collection,
handling, processing, storage, transport, or shipping. Secondary containers
are used when the outside of the primary container may be contaminated
and when puncture of the primary container is possible. Storage, transport,
or shipping containers are closed and labeled; the label should include
the biohazard symbol. Color-coded containers should be red or orange.
7.4.2.7 Potentially Contaminated Equipment
Any equipment to be serviced or shipped that may be
contaminated shall be examined prior to servicing or shipping and shall
be decontaminated as necessary. If decontamination is not feasible,
then the equipment shall be clearly labeled as to which portions remain
contaminated. The laboratory is obligated to clearly communicate this
information to employees, service personnel, and manufacturers as appropriate.
7.4.2.8 Other Engineering Controls
Other engineering controls include biological safety
cabinets and chemical fume hoods. Engineering controls shall be examined
and maintained on a regular schedule.
Chemical fume hoods used for containment of potentially
infectious material are inspected by ORS according to a regular schedule.
Facilities Management inspects and maintains chemical fume hood fan
and duct systems.
The principal investigator or supervisor is required
to ensure that biological safety cabinets used to protect workers from
hazardous biological agents shall be tested and certified after installation,
whenever they are moved, and annually. Certification shall be in accordance
with National Sanitation Foundation Standard Number 49.
7.5 Personal Protective Equipment
7.5.1 Responsibility
The principal investigator or supervisor shall provide
or ensure provision of appropriate personal protective equipment to
each employee who is subject to occupational exposure to human blood
or potentially infectious material. The equipment is provided at no
cost to the employee. Examples of such equipment include gloves, gowns,
laboratory coats, head and foot coverings, face shields, masks, eye
protection, resuscitation bags, pocket masks, or other ventilation devices.
The principal investigator or supervisor shall ensure
that each employee uses personal protective equipment when warranted.
Each principal investigator in charge of a laboratory
with employees covered under the Bloodborne Pathogens Standard shall
complete a Safety Plan
that documents the use of personal protective clothing and equipment
in detail.
7.5.2 Availability
Protective equipment in appropriate sizes shall be available
in the work area or issued to employees. Hypoallergenic gloves or similar
alternatives shall be readily available to those allergic to the normal
gloves provided.
7.5.3 Cleaning and Repair
The principal investigator or supervisor shall ensure
that personal protective equipment shall be cleaned, laundered, or disposed
of at no cost to the employee. Personal protective equipment shall be
repaired or replaced as needed to maintain its effectiveness.
7.5.4 Wear in Work Areas Only
All personal protective equipment shall be removed prior
to leaving the work area.
7.5.5 Gloves
Gloves shall be worn when it is reasonably anticipated
that employees may have hand contact with blood, other potentially infectious
materials, mucous membranes, and nonintact skin. Gloves shall be worn
when performing vascular access procedures and when handling or touching
contaminated items or surfaces.
Disposable gloves shall be replaced as soon as practical
when contaminated, torn, punctured, or otherwise compromised in their
ability to function as a barrier.
Utility gloves (nondisposable gloves) may be decontaminated
for reuse provided the integrity of the glove is not compromised. They
must be discarded if they are cracked, peeling, torn, punctured, or
exhibit other signs of deterioration.
There are specific regulations related to phlebotomy.
See the OSHA standard or contact ORS for details.
7.5.6 Masks, Eye Protection, and Face Shields
Masks in combination with eye protection devices (such
as goggles or glasses with solid side shields) or chin-length face shields,
shall be worn whenever splashes, spray, spatter, or droplets of blood
or other potentially infectious material may be generated and eye, nose,
or mouth contamination can be reasonably anticipated.
7.5.7 Gowns, Aprons, and Other Protective Body
Clothing
Appropriate protective body clothing shall be worn in
occupational exposure situations. When gross contamination can be anticipated,
surgical caps or hoods and shoe covers should be worn.
7.6 Housekeeping
7.6.1 Responsibility
The principal investigator or supervisor is responsible
for ensuring that the work area shall be maintained in a clean and sanitary
condition. A written schedule for cleaning and method of decontamination
is required.
7.6.2 Cleaning
All equipment and environmental and working surfaces
shall be cleaned and decontaminated with an appropriate disinfectant
after contact with blood or other potentially infectious material. Contaminated
work surfaces shall be decontaminated after completion of procedures,
immediately or as soon as feasible after any contamination of surfaces
or after any spill of blood or other potentially infectious materials,
and at the end of the work shift if the surface may have become contaminated
since the last cleaning.
Protective coverings such as plastic-backed absorbent
paper shall be removed and replaced as soon as feasible when they become
overtly contaminated or at the end of the work shift if they may have
become contaminated during the shift.
All bins, pails, cans, and similar receptacles intended
for reuse that have a reasonable likelihood of becoming contaminated
shall be inspected and decontaminated on a regularly scheduled basis.
They shall be cleaned or decontaminated immediately or as soon as feasible
if there is visible contamination.
Environmental surfaces (e.g., floors) are routinely
cleaned either by Facilities Management personnel or by an outside contractor
under the direction of Facilities Management. The schedule and method
of implementation are presented in their departmental procedures.
NOTE: Facilities Management or Housekeeping do
not clean contaminated floors. If floors are overtly contaminated
or suspected of being contaminated, department personnel shall clean
and decontaminate the floors using appropriate procedures.
The principal investigator or supervisor shall ensure
routine cleaning of work surfaces and equipment as well as cleaning
and disinfection of equipment, environmental surfaces, and work surfaces
that have been in contact with human blood or other infectious materials.
Chemical disinfectants are summarized in Table
7.3A and Table
7.3B in the Chemical and Biological Safety in Laboratory Program
with their usage parameters, applications and the organisms for which
they are effective. Any of the disinfectants listed are effective for
bloodborne pathogens. Purchased disinfectants are recommended if their
parameters meet those described.
7.6.3 Broken Glassware
Broken glassware that may be contaminated shall not
be picked up directly with the hands. It shall be cleaned up using mechanical
means, such as a brush or dustpan, a vacuum cleaner,tongs, or forceps.
7.7 Waste Disposal
7.7.1 Contaminated Sharps
Contaminated sharps shall be discarded immediately or
as soon as feasible in containers that are closable, puncture-resistant,
leakproof, and labeled or color-coded. Sharps containers shall be easily
accessible to employees and located close to the immediate area where
sharps will be used. Sharps containers shall be kept upright throughout
use, be replaced routinely, and not be allowed to be overfilled.
Before sharps containers are removed from the work area,
they shall be closed securely. If leakage is possible, a closable, sturdy,
leakproof, and labeled or color-coded secondary container shall be used.
Principal investigators or supervisors are responsible
for ensuring that appropriate sharps containers and other biohazardous
waste containers are made available and are used.
7.7.2 Other Biohazardous Wastes
Other waste containers that contain blood or other potentially
infectious material shall be closable, able to contain all contents,
leakproof, labeled and/or color-coded, and closed securely prior to
removal. If the primary waste container is contaminated on the outside,
a closable, sturdy, leakproof, and labeled or color-coded secondary
container shall be used, and it shall also be closed prior to removal.
7.8 Laundry
7.8.1 Instructions
Contaminated laundry shall be handled as little as possible
with a minimum of agitation. It shall be placed into bags or containers
at the point of use. It shall not be sorted or rinsed in the location
of use. The bags or containers shall be labeled with the biohazard symbol
or color-coded (red/orange). The bag or container shall be constructed
to prevent soak-through or leakage.
The principal investigator or supervisor shall ensure
that employees who handle contaminated laundry shall wear protective
gloves and other appropriate personal protective equipment.
Current University policy on the handling of contaminated
laundry requires that it be autoclaved or disinfected prior to
laundering. This enhances the protection of those individuals who have
to handle the laundry after it leaves the laboratory and simplifies
the laundry handling procedures in the facility which cleans it.
Contaminated sharps shall never be included with laundry.
Contaminated laundry is never washed with an individual's personal belongings
or sent to a laundry service not aware of the hazards.
7.9 Hepatitis B Vaccination and Postexposure Evaluation
and Follow-up
7.9.1 Responsibility
The principal investigator or supervisor is responsible
for making the hepatitis B vaccine and
vaccination series available to all employees who have occupational
exposure. Postexposure evaluation and follow-up shall be made available
to all employees who have sustained an exposure incident. All laboratory
tests shall be conducted by an accredited laboratory at no cost to the
employee.
Vaccine, vaccination, and all medical evaluations and
procedures
- shall be made available at no cost to the employee
- shall be made available at a reasonable time and place
- shall be performed by or under the supervision of a licensed
physician or other licensed healthcare professional
- shall be provided according to the recommendations of the U.S. Public
Health Service at the time the evaluations and procedures take place,
except as noted below
7.9.2 Hepatitis B Vaccination
Hepatitis B vaccination shall be made available. The
vaccination shall be provided/scheduled after the employee has
received the training required in the training section
of this document, and within 10 working days of initial assignment to
any employee who has occupational exposure unless the employee
has previously received the complete hepatitis B vaccination series,
antibody testing has revealed that the employee is immune, or the vaccine
is contraindicated for medical reasons. Participation by the employee
in a prescreening program shall not be a prerequisite for receiving
hepatitis B vaccination.
An employee who accepts vaccination shall complete and
sign the Consent/Waiver form.
An employee may decline vaccination but decide to accept
it at a later date in accordance with Section 7.9.1
above. If an employee declines vaccination, the employee shall sign
the statement also found in the Consent/Waiver
form.
Any booster doses that may be recommended by the U.S.
Public Health Service at a later date shall be made available in accordance
with the vaccination requirements of this section.
The healthcare professional responsible for the employee's
hepatitis B vaccination shall be provided with a copy of the OSHA Occupational
Exposure to Bloodborne Pathogens Standard. The written opinion for hepatitis
B vaccination shall depend on whether hepatitis B vaccination is indicated
and if the employee has received the vaccination.
Acceptable methods of compliance with the vaccination
requirement include in-house vaccination for departments having healthcare
professionals on the staff and at the University
Health Service (available to Evanston campus employees and to students
on both campuses). Chicago campus employees should contact their supervisor
for vaccination information. Contact ORS for information on recommended
healthcare providers or healthcare providers with whom the University
contracts to provide such services.
7.9.3 Postexposure Evaluation and Follow-up
7.9.3.1 Required Elements
Following a report of an exposure incident, the principal
investigator or supervisor shall ensure that a confidential medical
evaluation and follow-up are made available to the exposed employee.
The evaluation shall include
- documentation of the route of exposure and the circumstances under
which the exposure incident occurred
- identification and documentation of the source individual
unless it is not feasible or prohibited by law
- collection and testing of the exposed employee's blood for
HBV and HIV serological status
- collection of an exposed employee's blood as soon as feasible
and testing after consent is obtained: Testing may take place at a
later date if the employee chooses, provided it is within 90 days
of the exposure incident.
- postexposure prophylaxis, when medically indicated, as recommended
by the U.S. Public Health Service
- counseling
- evaluation of reported illnesses
See Appendix 3 for procedures,
or contact ORS for more information on where to obtain postexposure
exams and follow-up care.
7.9.3.2 Notification Requirement
When an exposure incident occurs, notify the Claims
Manager regarding workers' compensation if the exposed individual
is an employee. All incidents shall be reported to ORS by using an Incident
Report form for review by the Chemical and Biological Safety Committee.
In keeping with the confidentiality requirement of the University AIDS
policy, the names of persons involved in the incident and other identifying
information may be omitted from the incident report.
7.9.3.3 Information Provided to the Healthcare
Professional
The principal investigator or supervisor shall ensure
that the following information is supplied to the evaluating healthcare
professional. See Section 7.15 for the form
to be used.
The information shall include
- a copy of the OSHA Occupational Exposure to Bloodborne Pathogens
Standard
- a description of the exposed employee's duties as they relate
to the exposure incident
- documentation of the route of exposure and circumstances
under which the exposure occurred
- results of the source individual's blood testing, if available
- all medical records relevant to the appropriate treatment
of the employee including vaccination status that the department head
is responsible for maintaining.
7.9.3.4 Written Opinion Requirement
The principal investigator or supervisor is required
to obtain and provide the employee with a copy of the evaluating healthcare
professional's written opinion within 15 days of the completion of the
evaluation.
The healthcare professional's written opinion shall
be limited to whether hepatitis B vaccination is indicated for the employee
and, if the individual has received such vaccination, a statement that
the individual has been informed of the results of the evaluation and
that the individual has been told about any medical conditions resulting
from exposure to blood or other potentially infectious materials that
require further evaluation or treatment. All other findings or diagnoses
shall remain confidential and shall not be included in the written report.
All laboratory tests shall be conducted by an accredited
laboratory. The employer must be able to document (e.g., by certificate)
that the laboratory is accredited by a national accrediting body (such
as CDC or College of American Pathologists) or equivalent state agency
that participates in a recognized quality assurance program.
7.9.4 Medical Records
An accurate medical record for each employee with occupational
exposure is maintained. The record includes:
- name and Social Security number of the employee
- a copy of the employee's hepatitis B vaccination status,
including the dates of all the hepatitis B vaccinations and any medical
records relative to the employee's ability to receive vaccination
- a copy of all results of examinations, medical testing, and
follow-up procedures
- a copy of the healthcare professional's written opinion
- a copy of the information provided to the healthcare professional
Employee medical records shall be kept confidential and shall
not be disclosed or reported without the employee's express written
consent to any person except as required by the OSHA standard and by
law. If the employer has contracted with a clinic or other healthcare
facility to provide the follow-up programs, the confidentiality requirements
must be part of the contract.
When an exposure incident occurs, the results of the source
individual's testing become a part of the confidential medical record
and must be made available to the employee. Employees must be afforded
unrestricted access to their medical records.
Employee medical records shall be maintained for at least the
duration of employment plus 30 years.
7.10 Communication of Hazard to Employees: Labels
7.10.1 Labels
Warning labels are required on containers of biohazardous
waste (unless the waste is placed into red/orange bags), refrigerators
and freezers containing blood or other potentially infectious material,
and other containers used to store, transport, or ship blood or other
potentially infectious materials. The labels shall include the biohazard
symbol and the word "biohazard." The principal investigator
or supervisor shall ensure, either through inspection or delegation
to supervisory staff, that appropriate labels are in place. Labels
may be obtained from ORS.
7.11 Communication of Hazard to Employees: Information
and Training
7.11.1 Responsibility
Principal investigators or supervisors are responsible
for ensuring that all employees with occupational exposure participate
in a training program, which must be provided during working hours at
no cost to the employee.
7.11.2 Training Program Available
ORS maintains a training program on file on each campus
that, when supplemented by site-specific information and presented in
accordance with the criteria detailed below, can satisfy the training
requirement of the standard.
The training program may be checked out by trainers
for preview and presentation, and for copying of program documents.
The training program consists of
- a 24-minute video entitled "OSHA'S Bloodborne Pathogens Standard
for Laboratories." This video covers, in a general format, OSHA
regulations, protective equipment, and safe methods of performing
job duties
- a trainer's guide. The guide includes training tips, video
outlines and scripts, and self-tests and test keys
- video outlines for distribution to trainees
- self-test for trainees
- a handout entitled "Training
Information for the Bloodborne Pathogens Compliance Program."
This general training guide was developed by the Interinstitutional
Safety Task Force, a safety and health working group with representatives
from the member institutions of the McGaw Medical Center.
The University
Health Service employs health educators who can provide training
to employees. Contact the Health Service for details, including fee
information.
7.11.3 Schedule
Training shall be provided at the time of initial assignment
to tasks where occupational exposure may take place and at least annually
thereafter. Annual training shall be provided within one year of previous
training.
7.11.4 Additional Training
Principal investigators or supervisors shall ensure
that employees receive additional training when changes, such as modifications
of tasks and procedures or institution of new tasks or procedures, affect
the employee's occupational exposure.
7.11.5 Language, Literacy, and Educational
Level
Training shall consist of material appropriate in content
and vocabulary to the educational level, literacy, and language of employees.
If an employee is proficient in a foreign language only, the trainer
or an interpreter must convey the information in that language.
7.11.6 Content
As a minimum, the training program shall contain
- an accessible copy of the standard and an explanation of
its contents
- a general explanation of the epidemiology and symptoms of
bloodborne diseases
- an explanation of the modes of transmission of bloodborne
pathogens
- an explanation of the Exposure Control Plan and how to obtain
a copy of the written plan
- an explanation of how to recognize tasks and activities that
may involve exposure to blood and other potentially infectious materials
- an explanation of the use and limitations of methods that
will prevent or reduce exposure, including appropriate engineering
controls, work practices, and personal protective equipment
- information on the types, proper use, location, removal,
handling, decontamination, and disposal of personal protective equipment
- an explanation of the basis for the selection of personal
protective equipment
- information on the hepatitis B vaccine
- information on appropriate actions to take and persons to
contact in an emergency
- an explanation of the procedure to follow if an exposure
incident occurs
- information on postexposure evaluation and follow-up
- an explanation of the signs and labels and/or color coding
- an opportunity for interactive questions and answers
Common bloodborne diseases other than HIV and HBV, such as hepatitis
A and syphilis, must be described. Uncommon diseases do not need to
be described in detail unless employees work with particular bloodborne
pathogens.
7.11.7 Records
Training records
shall be maintained by the principal investigator or supervisor and
shall include the following information. Records shall include
- dates of training sessions
- contents or summary of the training sessions
- names and qualifications of persons conducting the training
- names and job titles of all persons attending the training
sessions
Training records shall be maintained for three years
from the date on which the training occurred. Training records shall
be provided on request for examination and copying to employees and
to employee representatives.
7.11.8 Implementation
The principal investigator or supervisor shall ensure
that all employees who are occupationally exposed receive training according
to the requirements of the OSHA standard.
Training may be provided through the use of a combination
of videotapes, handouts, pre- and post-tests, and personal presentations.
Each training session shall include an opportunity for employees to
ask questions. Training employees solely by means of a film or video
is not permitted unless the required site-specific information is presented
and a trainer is available to answer questions.
The person conducting the training is required to knowl
the subject matter covered by the training program, including site-specific
information. Possible trainers include a variety of healthcare professionals
such as infection control practitioners, nurse practitioners, registered
nurses, physician's assistants, or emergency medical technicians.
Non-healthcare professionals such as industrial hygienists,
epidemiologists, or professional trainers may conduct the training provided
they can demonstrate evidence of specialized training in the area of
bloodborne pathogens.
7.12 First Aid Provision
First aid providers whose primary job is not first aid
administration do not have to be offered pre-exposure hepatitis B vaccination,
according to OSHA. If the so-called secondary first aid providers are
exposed to human blood or other potentially infectious materials on the
job, the vaccine must then be offered within 24 hours of the incident.
In addition, appropriate postexposure evaluation, prophylaxis, and follow-up
must be provided to employees who have an exposure incident.
If you have secondary first aid providers in your department,
your written ECP must address this issue. It must include:
- a reporting procedure for incidents
- a list (a log) of first aid incidents
- documentation of employee training in the specifics
of the reporting procedure. Exposure incidents must be reported before
the end of the same shift during which the exposure incident occurred.
Technically, the failure to offer pre-exposure hepatitis
B vaccination is still a violation. As a matter of policy, OSHA considers
it a de minimis violation and citations will not be issued.
7.13 EXPOSURE DETERMINATION,
Parts 1 and 2
7.14 HEPATITIS B VACCINATION
CONSENT/WAIVER FORM
- 7.14.1 Information about hepatitis
B and hepatitis B Vaccine
7.15 INFORMATION PROVIDED
TO THE HEALTHCARE PROFESSIONAL
7.16 HEALTHCARE PROFESSIONAL'S
POSTEXPOSURE EVALUATION
7.17 EXPOSURE CONTROL PLAN
REVIEW/UPDATE
7.18 TRAINING RECORD
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[ BBP - 1.0 Introduction ]
[ BBP - 2.0 Responsibilities ]
[ BBP - 3.0 Exposure Control Plan ]
[ BBP - 4.0 Safety Plan ]
[ BBP - 5.0 Chemical and Biological Safety In Laboratories ]
[ BBP - 6.0 HIV and HBV Research Laboratories and Production Facilities ]
[ BBP - 7.0 Exposure Control Plan ]
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