(a) Scope and Application.
This section applies to all occupational exposure to blood or
other potentially infectious materials as defined by paragraph
(b) of this section.
(b) Definitions. For purposes of this section, the following
shall apply:
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, or designated representative.
Blood means human blood, human blood components, and products
made from human blood.
Bloodborne Pathogens means pathogenic microorganisms that are
present in human blood and can cause disease in humans. These
pathogens include, but are not limited to, hepatitis B virus
(HBV) and human immunodeficiency virus (HIV).
Clinical Laboratory means a workplace where diagnostic or other
screening procedures are performed on blood or other potentially
infectious materials.
Contaminated means the presence or the reasonably anticipated
presence of blood or other potentially infectious materials on an
item or surface.
Contaminated Laundry means laundry which has been soiled with
blood or other potentially infectious materials or may contain
sharps.
Contaminated Sharps means any contaminated object that can
penetrate the skin including, but not limited to, needles,
scalpels, broken glass, broken capillary tubes, and exposed ends
of dental wires.
Decontamination means the use of physical or chemical means to
remove, inactivate, or destroy bloodborne pathogens on a surface
or item to the point where they are no longer capable of
transmitting infectious particles and the surface or item is
rendered safe for handling, use, or disposal.
Director means the Director of the National Institute for
Occupational Safety and Health, U.S. Department of Health and
Human Services, or designated representative.
Engineering Controls means controls (e.g., sharps disposal
containers, self-sheathing needles) that isolate or remove the
bloodborne pathogens hazard from the workplace.
Exposure Incident means a specific eye, mouth, other mucous
membrane, non-intact skin, or parenteral contact with blood or
other potentially infectious materials that results from the
performance of an employee's duties.
Handwashing Facilities means a facility providing an adequate
supply of running potable water, soap and single use towels or
hot air drying machines.
Licensed Healthcare Professional is a person whose legally
permitted scope of practice allows him or her to independently
perform the activities required by paragraph (f) Hepatitis B
Vaccination and Post-exposure Evaluation and Follow-up.
HBV means hepatitis B virus.
HIV means human immunodeficiency virus.
Occupational Exposure means reasonably anticipated skin, eye,
mucous membrane, or parenteral contact with blood or other
potentially infectious materials that may result from the
performance of an employee's duties.
Other Potentially Infectious Materials means
(1) The following human body fluids: semen, vaginal secretions,
cerebrospinal fluid, synovial fluid, pleural fluid, pericardial
fluid, peritoneal fluid, amniotic fluid, saliva in dental
procedures, any body fluid that is visibly contaminated with
blood, and all body fluids in situations where it is difficult or
impossible to differentiate between body fluids;
(2) Any unfixed tissue or organ (other than intact skin) from a
human (living or dead); and
(3) HIV-containing cell or tissue cultures, organ cultures, and
HIV- or HBV-containing culture medium or other solutions; and
blood, organs, or other tissues from experimental animals
infected with HIV or HBV.
Parenteral means piercing mucous membranes or the skin barrier
through such events as needlesticks, human bites, cuts, and
abrasions.
Personal Protective Equipment is specialized clothing or
equipment worn by an employee for protection against a hazard.
General work clothes (e.g., uniforms, pants, shirts or blouses)
not intended to function as protection against a hazard are not
considered to be personal protective equipment.
Production Facility means a facility engaged in industrial-scale,
large-volume or high concentration production of HIV or HBV.
Regulated Waste means liquid or semi-liquid blood or other
potentially infectious materials; contaminated items that would
release blood or other potentially infectious materials in a
liquid or semi-liquid state if compressed; items that are caked
with dried blood or other potentially infectious materials and
are capable of releasing these materials during handling;
contaminated sharps; and pathological and microbiological wastes
containing blood or other potentially infectious material.
Research Laboratory means a laboratory producing or using
research-laboratory-scale amounts of HIV or HBV. Research
laboratories may produce high concentrations of HIV or HBV but
not in the volume found in production facilities.
Source Individual means any individual, living or dead, whose
blood or other potentially infectious materials may be a source
of occupational exposure to the employee. Examples include, but
are not limited to, hospital and clinic patients; clients in
institutions for the developmentally disabled; trauma victims;
clients of drug and alcohol treatment facilities; residents of
hospices and nursing homes; human remains; and individuals who
donate or sell blood or blood components.
Sterilize means the use of a physical or chemical procedure to
destroy all microbial life including highly resistant bacterial
endospores.
Universal Precautions is an approach to infection control.
According to the concept of Universal Precautions, all human
blood and certain human body fluids are treated as if known to be
infectious for HIV, HBV, and other bloodborne pathogens.
Work Practice Controls means controls that reduce the likelihood
of exposure by altering the manner in which a task is performed
(e.g., prohibiting recapping of needles by a two-handed
technique).
(c) Exposure control -- (1) Exposure Control Plan. (i) Each
employer having an employee(s) with occupational exposure as
defined by paragraph (b) of this section shall establish a
written Exposure Control Plan designed to eliminate or minimize
employee exposure.
(ii) The Exposure Control Plan shall contain at least the
following elements:
(A) The exposure determination required by paragraph(c)(2),
(B) The schedule and method of implementation for paragraphs (d)
Methods of Compliance, (e) HIV and HBV Research Laboratories and
Production Facilities, (f) Hepatitis B Vaccination and
Post-Exposure Evaluation and Follow-up, (g) Communication of
Hazards to Employees, and (h) Recordkeeping, of this standard,
and
(C) The procedure for the evaluation of circumstances surrounding
exposure incidents as required by paragraph (f)(3)(i) of this
standard.
(iii) Each employer shall ensure that a copy of the Exposure
Control Plan is accessible to employees in accordance with 29 CFR
§1910.20(e).
(iv) The Exposure Control Plan shall be reviewed and updated at
least annually and whenever necessary to reflect new or modified
tasks and procedures which affect occupational exposure and to
reflect new or revised employee positions with occupational
exposure.
(v) The Exposure Control Plan shall be made available to the
Assistant Secretary and the Director upon request for examination
and copying.
(2) Exposure determination.
(i) Each employer who has an employee(s) with occupational
exposure as defined by paragraph (b) of this section shall
prepare an exposure determination. This exposure determination
shall contain the following:
(A) A list of all job classifications in which all employees in
those job classifications have occupational exposure;
(B) A list of job classifications in which some employees have
occupational exposure, and
(C) A list of all tasks and procedures or groups of closely
related task and procedures in which occupational exposure occurs
and that are performed by employees in job classifications listed
in accordance with the provisions of paragraph (c)(2)(i)(B) of
this standard.
(ii) This exposure determination shall be made without regard to
the use of personal protective equipment.
(d) Methods of compliance -- (1) General -- Universal precautions
shall be observed to prevent contact with blood or other
potentially infectious materials. Under circumstances in which
differentiation between body fluid types is difficult or
impossible, all body fluids shall be considered potentially
infectious materials.
(2) Engineering and work practice controls.
(i) Engineering and work practice controls shall be used to
eliminate or minimize employee exposure. Where occupational
exposure remains after institution of these controls, personal
protective equipment shall also be used.
(ii) Engineering controls shall be examined and maintained or
replaced on a regular schedule to ensure their effectiveness.
(iii) Employers shall provide handwashing facilities which are
readily accessible to employees.
(iv) When provision of handwashing facilities is not feasible,
the employer shall provide either an appropriate antiseptic hand
cleanser in conjunction with clean cloth/paper towels or
antiseptic towelettes. When antiseptic hand cleansers or
towelettes are used, hands shall be washed with soap and running
water as soon as feasible.
(v) Employers shall ensure that employees wash their hands
immediately or as soon as feasible after removal of gloves or
other personal protective equipment.
(vi) Employers 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 blood or other potentially infectious
materials.
(vii) Contaminated needles and other contaminated sharps shall
not be bent, recapped, or removed except as noted in paragraphs
(d)(2)(vii)(A) and (d)(2)(vii)(B) below. Shearing or breaking of
contaminated needles is prohibited.
(A) Contaminated needles and other contaminated sharps shall not
be bent, recapped or removed unless the employer can demonstrate
that no alternative is feasible or that such action is required
by a specific medical or dental procedure.
(B) Such bending, recapping or needle removal must be
accomplished through the use of a mechanical device or a
one-handed technique.
(viii) Immediately or as soon as possible after use, contaminated
reusable sharps shall be placed in appropriate containers until
properly reprocessed. These containers shall be:
(A) Puncture resistant;
(B) Labeled or color-coded in accordance with this standard;
(C) Leakproof on the sides and bottom; and
(D) In accordance with the requirements set forth in paragraph
(d)(4)(ii)(E) for reusable sharps.
(ix) 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.
(x) 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.
(xi) All procedures involving blood or other potentially
infectious materials shall be performed in such a manner as to
minimize splashing, spraying, spattering, and generation of
droplets of these substances.
(xii) Mouth pipetting/suctioning of blood or other potentially
infectious materials is prohibited.
(xiii) Specimens of blood or other potentially infectious
materials shall be placed in a container which prevents leakage
during collection, handling, processing, storage, transport, or
shipping.
(A) The container for storage, transport, or shipping shall be
labeled or color-coded according to paragraph (g)(1)(i) and
closed prior to being stored, transported, or shipped. When a
facility utilizes Universal Precautions in the handling of all
specimens, the labeling/color-coding of specimens is not
necessary provided containers are recognizable as containing
specimens. This exemption only applies while such
specimens/containers remain within the facility. Labeling or
color-coding in accordance with paragraph (g)(1)(i) is required
when such specimens/containers leave the facility.
(B) If outside contamination of the primary container occurs, the
primary container shall be placed within a second container which
prevents leakage during handling, processing, storage, transport,
or shipping and is labeled or color-coded according to the
requirements of this standard.
(C) If the specimen could puncture the primary container, the
primary container shall be placed within a secondary container
which is puncture-resistant in addition to the above
characteristics.
(xiv) Equipment which may become contaminated with blood or other
potentially infectious materials shall be examined prior to
servicing or shipping and shall be decontaminated as necessary,
unless the employer can demonstrate that decontamination of such
equipment or portions of such equipment is not feasible.
(A) A readily observable label in accordance with paragraph
(g)(1)(i)(H) shall be attached to the equipment stating which
portions remain contaminated.
(B) The employer shall ensure that this information is conveyed
to all affected employees, the servicing representative, and/or
the manufacturer, as appropriate, prior to handling, servicing,
or shipping so that appropriate precautions will be taken.
(3) Personal protective equipment --
(i) Provision. When there is occupational exposure, the employer
shall provide, at no cost to the employee, appropriate personal
protective equipment such as, but not limited to, gloves, gowns,
laboratory coats, face shields or masks and eye protection, and
mouthpieces, resuscitation bags, pocket masks, or other
ventilation devices. Personal protective equipment will be
considered "appropriate'' only if it does not permit blood
or other potentially infectious materials to pass through to or
reach the employee's work clothes, street clothes, undergarments,
skin, eyes, mouth, or other mucous membranes under normal
conditions of use and for the duration of time which the
protective equipment will be used.
(ii) Use. The employer shall ensure that the employee uses
appropriate personal protective equipment unless the employer
shows that the employee temporarily and briefly declined to use
personal protective equipment when, under rare and extraordinary
circumstances, it was the employee's professional judgment that
in the specific instance its use would have prevented the
delivery of health care or public safety services or would have
posed an increased hazard to the safety of the worker or
co-worker. When the employee makes this judgement, the
circumstances shall be investigated and documented in order to
determine whether changes can be instituted to prevent such
occurences in the future.
(iii) Accessibility. The employer shall ensure that appropriate
personal protective equipment in the appropriate sizes is readily
accessible at the worksite or is issued to employees.
Hypoallergenic gloves, glove liners, powderless gloves, or other
similar alternatives shall be readily accessible to those
employees who are allergic to the gloves normally provided.
(iv) Cleaning, Laundering, and Disposal. The employer shall
clean, launder, and dispose of personal protective equipment
required by paragraphs (d) and (e) of this standard, at no cost
to the employee.
(v) Repair and Replacement. The employer shall repair or replace
personal protective equipment as needed to maintain its
effectiveness, at no cost to the employee.
(vi) If a garment(s) is penetrated by blood or other potentially
infectious materials, the garment(s) shall be removed immediately
or as soon as feasible.
(vii) All personal protective equipment shall be removed prior to
leaving the work area.
(viii) When personal protective equipment is removed it shall be
placed in an appropriately designated area or container for
storage, washing, decontamination or disposal.
(ix) Gloves. Gloves shall be worn when it can be reasonably
anticipated that the employee may have hand contact with blood,
other potentially infectious materials, mucous membranes, and
non-intact skin; when performing vascular access procedures
except as specified in paragraph (d)(3)(ix)(D); and when handling
or touching contaminated items or surfaces.
(A) Disposable (single use) gloves such as surgical or
examination gloves, shall be replaced as soon as practical when
contaminated or as soon as feasible if they are torn, punctured,
or when their ability to function as a barrier is compromised.
(B) Disposable (single use) gloves shall not be washed or
decontaminated for re-use.
(C) Utility gloves may be decontaminated for re-use if the
integrity of the glove is not compromised. However, they must be
discarded if they are cracked, peeling, torn, punctured, or
exhibit other signs of deterioration or when their ability to
function as a barrier is compromised.
(D) If an employer in a volunteer blood donation center judges
that routine gloving for all phlebotomies is not necessary then
the employer shall:
(1) Periodically reevaluate this policy;
(2) Make gloves available to all employees who wish to use them
for phlebotomy;
(3) Not discourage the use of gloves for phlebotomy; and
(4) Require that gloves be used for phlebotomy in the following
circumstances:
(i) When the employee has cuts, scratches, or other breaks in his
or her skin;
(ii) When the employee judges that hand contamination with blood
may occur, for example, when performing phlebotomy on an
uncooperative source individual; and
(iii) When the employee is receiving training in phlebotomy.
(x) 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 materials may be generated and eye, nose,
or mouth contamination can be reasonably anticipated.
(xi) Gowns, Aprons, and Other Protective Body Clothing.
Appropriate protective clothing such as, but not limited to,
gowns, aprons, lab coats, clinic jackets, or similar outer
garments shall be worn in occupational exposure situations. The
type and characteristics will depend upon the task and degree of
exposure anticipated.
(xii) Surgical caps or hoods and/or shoe covers or boots shall be
worn in instances when gross contamination can reasonably be
anticipated (e.g., autopsies, orthopedic surgery).
(4) Housekeeping. (i) General. Employers shall ensure that the
worksite is maintained in a clean and sanitary condition. The
employer shall determine and implement an appropriate written
schedule for cleaning and method of decontamination based upon
the location within the facility, type of surface to be cleaned,
type of soil present, and tasks or procedures being performed in
the area.
(ii) All equipment and environmental and working surfaces shall
be cleaned and decontaminated after contact with blood or other
potentially infectious materials.
(A) Contaminated work surfaces shall be decontaminated with an
appropriate disinfectant after completion of procedures;
immediately or as soon as feasible when surfaces are overtly
contaminated 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.
(B) Protective coverings, such as plastic wrap, aluminum foil, or
imperviously-backed absorbent paper used to cover equipment and
environmental surfaces, shall be removed and replaced as soon as
feasible when they become overtly contaminated or at the end of
the workshift if they may have become contaminated during the
shift.
(C) All bins, pails, cans, and similar receptacles intended for
reuse which have a reasonable likelihood for becoming
contaminated with blood or other potentially infectious materials
shall be inspected and decontaminated on a regularly scheduled
basis and cleaned and decontaminated immediately or as soon as
feasible upon visible contamination.
(D) Broken glassware which may be contaminated shall not be
picked up directly with the hands. It shall be cleaned up using
mechanical means, such as a brush and dust pan, tongs, or
forceps.
(E) Reusable sharps that are contaminated with blood or other
potentially infectious materials shall not be stored or processed
in a manner that requires employees to reach by hand into the
containers where these sharps have been placed.
(iii) Regulated Waste.
(A) Contaminated Sharps Discarding and Containment. (1)
Contaminated sharps shall be discarded immediately or as soon as
feasible in containers that are:
(i) Closable;
(ii) Puncture resistant;
(iii) Leakproof on sides and bottom; and
(iv) Labeled or color-coded in accordance with paragraph
(g)(1)(i) of this standard.
(2) During use, containers for contaminated sharps shall be:
(i) Easily accessible to personnel and located as close as is
feasible to the immediate area where sharps are used or can be
reasonably anticipated to be found (e.g., laundries);
(ii) Maintained upright throughout use; and
(iii) Replaced routinely and not be allowed to overfill.
(3) When moving containers of contaminated sharps from the area
of use, the containers shall be:
(i) Closed immediately prior to removal or replacement to prevent
spillage or protrusion of contents during handling, storage,
transport, or shipping;
(ii) Placed in a secondary container if leakage is possible. The
second container shall be:
(A) Closable;
(B) Constructed to contain all contents and prevent leakage
during handling, storage, transport, or shipping; and
(C) Labeled or color-coded according to paragraph (g)(1)(i) of
this standard.
(4) Reusable containers shall not be opened, emptied, or cleaned
manually or in any other manner which would expose employees to
the risk of percutaneous injury.
(B) Other Regulated Waste Containment.(1) Regulated waste shall
be placed in containers which are:
(i) Closable;
(ii) Constructed to contain all contents and prevent leakage of
fluids during handling, storage, transport or shipping;
(iii) Labeled or color-coded in accordance with paragraph
(g)(1)(i) this standard; and
(iv) Closed prior to removal to prevent spillage or protrusion of
contents during handling, storage, transport, or shipping.
(2) If outside contamination of the regulated waste container
occurs, it shall be placed in a second container. The second
container shall be:
(i) Closable;
(ii) Constructed to contain all contents and prevent leakage of
fluids during handling, storage, transport or shipping;
(iii) Labeled or color-coded in accordance with paragraph
(g)(1)(i) of this standard; and
(iv) Closed prior to removal to prevent spillage or protrusion of
contents during handling, storage, transport, or shipping.
(C) Disposal of all regulated waste shall be in accordance with
applicable regulations of the United States, States and
Territories, and political subdivisions of States and
Territories.
(iv) Laundry.
(A) Contaminated laundry shall be handled as little as possible
with a minimum of agitation. (1) Contaminated laundry shall be
bagged or containerized at the location where it was used and
shall not be sorted or rinsed in the location of use.
(2) Contaminated laundry shall be placed and transported in bags
or containers labeled or color-coded in accordance with paragraph
(g)(1)(i) of this standard. When a facility utilizes Universal
Precautions in the handling of all soiled laundry, alternative
labeling or color-coding is sufficient if it permits all
employees to recognize the containers as requiring compliance
with Universal Precautions.
(3) Whenever contaminated laundry is wet and presents a
reasonable likelihood of soak-through of or leakage from the bag
or container, the laundry shall be placed and transported in bags
or containers which prevent soak-through and/or leakage of fluids
to the exterior.
(B) The employer shall ensure that employees who have contact
with contaminated laundry wear protective gloves and other
appropriate personal protective equipment.
(C) When a facility ships contaminated laundry off-site to a
second facility which does not utilize Universal Precautions in
the handling of all laundry, the facility generating the
contaminated laundry must place such laundry in bags or
containers which are labeled or color-coded in accordance with
paragraph (g)(1)(i).
29 CFR §1910.1030
(e) HIV and HBV Research
Laboratories and Production Facilities.(1) This paragraph applies
to research laboratories and production facilities engaged in the
culture, production, concentration, experimentation, and
manipulation of HIV and HBV. It does not apply to clinical or
diagnostic laboratories engaged solely in the analysis of blood,
tissues, or organs. These requirements apply in addition to the
other requirements of the standard.
(2) Research laboratories and production facilities shall meet
the following criteria:
(i) Standard microbiological practices. All regulated waste shall
either be incinerated or decontaminated by a method such as
autoclaving known to effectively destroy bloodborne pathogens.
(ii) Special practices.
(A) Laboratory doors shall be kept closed when work involving HIV
or HBV is in progress.
(B) Contaminated materials that are to be decontaminated at a
site away from the work area shall be placed in a durable,
leakproof, labeled or color-coded container that is closed before
being removed from the work area.
(C) Access to the work area shall be limited to authorized
persons. Written policies and procedures shall be established
whereby only persons who have been advised of the potential
biohazard, who meet any specific entry requirements, and who
comply with all entry and exit procedures shall be allowed to
enter the work areas and animal rooms.
(D) When other potentially infectious materials or infected
animals are present in the work area or containment module, a
hazard warning sign incorporating the universal biohazard symbol
shall be posted on all access doors. The hazard warning sign
shall comply with paragraph (g)(1)(ii) of this standard.
(E) All activities involving other potentially infectious
materials shall be conducted in biological safety cabinets or
other physical-containment devices within the containment module.
No work with these other potentially infectious materials shall
be conducted on the open bench.
(F) Laboratory coats, gowns, smocks, uniforms, or other
appropriate protective clothing shall be used in the work area
and animal rooms. Protective clothing shall not be worn outside
of the work area and shall be decontaminated before being
laundered.
(G) Special care shall be taken to avoid skin contact with other
potentially infectious materials. Gloves shall be worn when
handling infected animals and when making hand contact with other
potentially infectious materials is unavoidable.
(H) Before disposal all waste from work areas and from animal
rooms shall either be incinerated or decontaminated by a method
such as autoclaving known to effectively destroy bloodborne
pathogens.
(I) Vacuum lines shall be protected with liquid disinfectant
traps and high-efficiency particulate air (HEPA) filters or
filters of equivalent or superior efficiency and which are
checked routinely and maintained or replaced as necessary.
(J) Hypodermic needles and syringes shall be used only for
parenteral injection and aspiration of fluids from laboratory
animals and diaphragm bottles. Only needle-locking syringes or
disposable syringe-needle units (i.e., the needle is integral to
the syringe) shall be used for the injection or aspiration of
other potentially infectious materials. Extreme caution shall be
used when handling needles and syringes. A needle shall not be
bent, sheared, replaced in the sheath or guard, or removed from
the syringe following use. The needle and syringe shall be
promptly placed in a puncture-resistant container and autoclaved
or decontaminated before reuse or disposal.
(K) All spills shall be immediately contained and cleaned up by
appropriate professional staff or others properly trained and
equipped to work with potentially concentrated infectious
materials.
(L) A spill or accident that results in an exposure incident
shall be immediately reported to the laboratory director or other
responsible person.
(M) A biosafety manual shall be prepared or adopted and
periodically reviewed and updated at least annually or more often
if necessary. Personnel shall be advised of potential hazards,
shall be required to read instructions on practices and
procedures, and shall be required to follow them.
(iii) Containment equipment. (A) Certified biological safety
cabinets (Class I, II, or III) or other appropriate combinations
of personal protection or physical containment devices, such as
special protective clothing, respirators, centrifuge safety cups,
sealed centrifuge rotors, and containment caging for animals,
shall be used for all activities with other potentially
infectious materials that pose a threat of exposure to droplets,
splashes, spills, or aerosols.
(B) Biological safety cabinets shall be certified when installed,
whenever they are moved and at least annually.
(3) HIV and HBV research laboratories shall meet the following
criteria:
(i) Each laboratory shall contain a facility for hand washing and
an eye wash facility which is readily available within the work
area.
(ii) An autoclave for decontamination of regulated waste shall be
available.
(4) HIV and HBV production facilities shall meet the following
criteria:
(i) The work areas shall be separated from areas that are open to
unrestricted traffic flow within the building. Passage through
two sets of doors shall be the basic requirement for entry into
the work area from access corridors or other contiguous areas.
Physical separation of the high-containment work area from access
corridors or other areas or activities may also be provided by a
double-doored clothes-change room (showers may be included),
airlock, or other access facility that requires passing through
two sets of doors before entering the work area.
(ii) The surfaces of doors, walls, floors and ceilings in the
work area shall be water resistant so that they can be easily
cleaned. Penetrations in these surfaces shall be sealed or
capable of being sealed to facilitate decontamination.
(iii) Each work area shall contain a sink for washing hands and a
readily available eye wash facility. The sink shall be foot,
elbow, or automatically operated and shall be located near the
exit door of the work area.
(iv) Access doors to the work area or containment module shall be
self-closing.
(v) An autoclave for decontamination of regulated waste shall be
available within or as near as possible to the work area.
(vi) A ducted exhaust-air ventilation system shall be provided.
This system shall create directional airflow that draws air into
the work area through the entry area. The exhaust air shall not
be recirculated to any other area of the building, shall be
discharged to the outside, and shall be dispersed away from
occupied areas and air intakes. The proper direction of the
airflow shall be verified (i.e., into the work area).
(5) Training Requirements. Additional training requirements for
employees in HIV and HBV research laboratories and HIV and HBV
production facilities are specified in paragraph (g)(2)(ix).
(f) Hepatitis B vaccination and post-exposure evaluation and
follow-up -- (1) General. (i) The employer shall make available
the hepatitis B vaccine and vaccination series to all employees
who have occupational exposure, and post-exposure evaluation and
follow-up to all employees who have had an exposure incident.
(ii) The employer shall ensure that all medical evaluations and
procedures including the hepatitis B vaccine and vaccination
series and post-exposure evaluation and follow-up, including
prophylaxis, are:
(A) Made available at no cost to the employee;
(B) Made available to the employee at a reasonable time and
place;
(C) Performed by or under the supervision of a licensed physician
or by or under the supervision of another licensed healthcare
professional; and
(D) Provided according to recommendations of the U.S. Public
Health Service current at the time these evaluations and
procedures take place, except as specified by this paragraph (f).
(iii) The employer shall ensure that all laboratory tests are
conducted by an accredited laboratory at no cost to the employee.
(2) Hepatitis B Vaccination. (i) Hepatitis B vaccination shall be
made available after the employee has received the training
required in paragraph (g)(2)(vii)(I) and within 10 working days
of initial assignment to all employees who have 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.
(ii) The employer shall not make participation in a prescreening
program a prerequisite for receiving hepatitis B vaccination.
(iii) If the employee initially declines hepatitis B vaccination
but at a later date while still covered under the standard
decides to accept the vaccination, the employer shall make
available hepatitis B vaccination at that time.
(iv) The employer shall assure that employees who decline to
accept hepatitis B vaccination offered by the employer sign the
statement in appendix A.
(v) If a routine booster dose(s) of hepatitis B vaccine is
recommended by the U.S. Public Health Service at a future date,
such booster dose(s) shall be made available in accordance with
section (f)(1)(ii).
(3) Post-exposure Evaluation and Follow-up. Following a report of
an exposure incident, the employer shall make immediately
available to the exposed employee a confidential medical
evaluation and follow-up, including at least the following
elements:
(i) Documentation of the route(s) of exposure, and the
circumstances under which the exposure incident occurred;
(ii) Identification and documentation of the source individual,
unless the employer can establish that identification is
infeasible or prohibited by state or local law;
(A) The source individual's blood shall be tested as soon as
feasible and after consent is obtained in order to determine HBV
and HIV infectivity. If consent is not obtained, the employer
shall establish that legally required consent cannot be obtained.
When the source individual's consent is not required by law, the
source individual's blood, if available, shall be tested and the
results documented.
(B) When the source individual is already known to be infected
with HBV or HIV, testing for the source individual's known HBV or
HIV status need not be repeated.
(C) Results of the source individual's testing shall be made
available to the exposed employee, and the employee shall be
informed of applicable laws and regulations concerning disclosure
of the identity and infectious status of the source individual.
(iii) Collection and testing of blood for HBV and HIV serological
status;
(A) The exposed employee's blood shall be collected as soon as
feasible and tested after consent is obtained.
(B) If the employee consents to baseline blood collection, but
does not give consent at that time for HIV serologic testing, the
sample shall be preserved for at least 90 days. If, within 90
days of the exposure incident, the employee elects to have the
baseline sample tested, such testing shall be done as soon as
feasible.
(iv) Post-exposure prophylaxis, when medically indicated, as
recommended by the U.S. Public Health Service;
(v) Counseling; and
(vi) Evaluation of reported illnesses.
(4) Information Provided to the Healthcare Professional. (i) The
employer shall ensure that the healthcare professional
responsible for the employee's Hepatitis B vaccination is
provided a copy of this regulation.
(ii) The employer shall ensure that the healthcare professional
evaluating an employee after an exposure incident is provided the
following information:
(A) A copy of this regulation;
(B) A description of the exposed employee's duties as they relate
to the exposure incident;
(C) Documentation of the route(s) of exposure and circumstances
under which exposure occurred;
(D) Results of the source individual's blood testing, if
available; and
(E) All medical records relevant to the appropriate treatment of
the employee including vaccination status which are the
employer's responsibility to maintain.
(5) Healthcare Professional's Written Opinion. The employer shall
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.
(i) The healthcare professional's written opinion for Hepatitis B
vaccination shall be limited to whether Hepatitis B vaccination
is indicated for an employee, and if the employee has received
such vaccination.
(ii) The healthcare professional's written opinion for
post-exposure evaluation and follow-up shall be limited to the
following information:
(A) That the employee has been informed of the results of the
evaluation; and
(B) That the employee has been told about any medical conditions
resulting from exposure to blood or other potentially infectious
materials which require further evaluation or treatment. (iii)
All other findings or diagnoses shall remain confidential and
shall not be included in the written report.
(6) Medical recordkeeping. Medical records required by this
standard shall be maintained in accordance with paragraph (h)(1)
of this section.
(g) Communication of hazards to employees -- (1) Labels and
signs. (i) Labels. (A) Warning labels shall be affixed to
containers of regulated waste, 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, except as provided in paragraph
(g)(1)(i)(E), (F) and (G).
(B) Labels required by this section shall include the following
legend:
ILLUSTRATION OMITTED
(C) These labels shall be fluorescent orange or orange-red or
predominantly so, with lettering and symbols in a contrasting
color.
(D) Labels shall be affixed as close as feasible to the container
by string, wire, adhesive, or other method that prevents their
loss or unintentional removal.
(E) Red bags or red containers may be substituted for labels.
(F) Containers of blood, blood components, or blood products that
are labeled as to their contents and have been released for
transfusion or other clinical use are exempted from the labeling
requirements of paragraph (g).
(G) Individual containers of blood or other potentially
infectious materials that are placed in a labeled container
during storage, transport, shipment or disposal are exempted from
the labeling requirement.
(H) Labels required for contaminated equipment shall be in
accordance with this paragraph and shall also state which
portions of the equipment remain contaminated.
(I) Regulated waste that has been decontaminated need not be
labeled or color-coded.
(ii) Signs. (A) The employer shall post signs at the entrance to
work areas specified in paragraph (e), HIV and HBV Research
Laboratory and Production Facilities, which shall bear the
following legend:
ILLUSTRATION OMITTED
(Name of the Infectious Agent)
(Special requirements for entering the area)
(Name, telephone number of the laboratory director or other
responsible person.)
(B) These signs shall be fluorescent orange-red or predominantly
so, with lettering and symbols in a contrasting color.
(2) Information and Training. (i) Employers shall ensure that all
employees with occupational exposure participate in a training
program which must be provided at no cost to the employee and
during working hours.
(ii) Training shall be provided as follows:
(A) At the time of initial assignment to tasks where occupational
exposure may take place;
(B) Within 90 days after the effective date of the standard; and
(C) At least annually thereafter.
(iii) For employees who have received training on bloodborne
pathogens in the year preceding the effective date of the
standard, only training with respect to the provisions of the
standard which were not included need be provided.
(iv) Annual training for all employees shall be provided within
one year of their previous training.
(v) Employers shall provide additional training when changes such
as modification of tasks or procedures or institution of new
tasks or procedures affect the employee's occupational exposure.
The additional training may be limited to addressing the new
exposures created.
(vi) Material appropriate in content and vocabulary to
educational level, literacy, and language of employees shall be
used.
(vii) The training program shall contain at a minimum the
following elements:
(A) An accessible copy of the regulatory text of this standard
and an explanation of its contents;
(B) A general explanation of the epidemiology and symptoms of
bloodborne diseases;
(C) An explanation of the modes of transmission of bloodborne
pathogens;
(D) An explanation of the employer's exposure control plan and
the means by which the employee can obtain a copy of the written
plan;
(E) An explanation of the appropriate methods for recognizing
tasks and other activities that may involve exposure to blood and
other potentially infectious materials;
(F) 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;
(G) Information on the types, proper use, location, removal,
handling, decontamination and disposal of personal protective
equipment;
(H) An explanation of the basis for selection of personal
protective equipment;
(I) Information on the hepatitis B vaccine, including information
on its efficacy, safety, method of administration, the benefits
of being vaccinated, and that the vaccine and vaccination will be
offered free of charge;
(J) Information on the appropriate actions to take and persons to
contact in an emergency involving blood or other potentially
infectious materials;
(K) An explanation of the procedure to follow if an exposure
incident occurs, including the method of reporting the incident
and the medical follow-up that will be made available;
(L) Information on the post-exposure evaluation and follow-up
that the employer is required to provide for the employee
following an exposure incident;
(M) An explanation of the signs and labels and/or color coding
required by paragraph (g)(1); and
(N) An opportunity for interactive questions and answers with the
person conducting the training session.
(viii) The person conducting the training shall be knowledgeable
in the subject matter covered by the elements contained in the
training program as it relates to the workplace that the training
will address.
(ix) Additional Initial Training for Employees in HIV and HBV
Laboratories and Production Facilities. Employees in HIV or HBV
research laboratories and HIV or HBV production facilities shall
receive the following initial training in addition to the above
training requirements.
(A) The employer shall assure that employees demonstrate
proficiency in standard microbiological practices and techniques
and in the practices and operations specific to the facility
before being allowed to work with HIV or HBV.
(B) The employer shall assure that employees have prior
experience in the handling of human pathogens or tissue cultures
before working with HIV or HBV.
(C) The employer shall provide a training program to employees
who have no prior experience in handling human pathogens. Initial
work activities shall not include the handling of infectious
agents. A progression of work activities shall be assigned as
techniques are learned and proficiency is developed. The employer
shall assure that employees participate in work activities
involving infectious agents only after proficiency has been
demonstrated.
(h) Recordkeeping -- (1) Medical Records. (i) The employer shall
establish and maintain an accurate record for each employee with
occupational exposure, in accordance with 29 CFR §1910.20.
(ii) This record shall include:
(A) The name and social security number of the employee;
(B) 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 as required by paragraph (f)(2);
(C) A copy of all results of examinations, medical testing, and
follow-up procedures as required by paragraph (f)(3);
(D) The employer's copy of the healthcare professional's written
opinion as required by paragraph (f)(5); and
(E) A copy of the information provided to the healthcare
professional as required by paragraphs (f)(4)(ii)(B)(C) and (D).
(iii) Confidentiality. The employer shall ensure that employee
medical records required by paragraph (h)(1) are:
(A) Kept confidential; and
(B) Not disclosed or reported without the employee's express
written consent to any person within or outside the workplace
except as required by this section or as may be required by law.
(iv) The employer shall maintain the records required by
paragraph (h) for at least the duration of employment plus 30
years in accordance with 29 CFR §1910.20.
(2) Training Records. (i) Training records shall include the
following information:
(A) The dates of the training sessions;
(B) The contents or a summary of the training sessions;
(C) The names and qualifications of persons conducting the
training; and
(D) The names and job titles of all persons attending the
training sessions.
(ii) Training records shall be maintained for 3 years from the
date on which the training occurred.
(3) Availability. (i) The employer shall ensure that all records
required to be maintained by this section shall be made available
upon request to the Assistant Secretary and the Director for
examination and copying.
(ii) Employee training records required by this paragraph shall
be provided upon request for examination and copying to
employees, to employee representatives, to the Director, and to
the Assistant Secretary.
(iii) Employee medical records required by this paragraph shall
be provided upon request for examination and copying to the
subject employee, to anyone having written consent of the subject
employee, to the Director, and to the Assistant Secretary in
accordance with 29 CFR §1910.20.
(4) Transfer of Records. (i) The employer shall comply with the
requirements involving transfer of records set forth in 29 CFR
§1910.20(h).
(ii) If the employer ceases to do business and there is no
successor employer to receive and retain the records for the
prescribed period, the employer shall notify the Director, at
least three months prior to their disposal and transmit them to
the Director, if required by the Director to do so, within that
three month period.
(i) Dates -- (1) Effective Date. The standard shall become
effective on March 6, 1992.
(2) The Exposure Control Plan required by paragraph (c) of this
section shall be completed on or before May 5, 1992.
(3) Paragraph (g)(2) Information and Training and (h)
Recordkeeping shall take effect on or before June 4, 1992.
(4) Paragraphs (d)(2) Engineering and Work Practice Controls,
(d)(3) Personal Protective Equipment, (d)(4) Housekeeping, (e)
HIV and HBV Research Laboratories and Production Facilities, (f)
Hepatitis B Vaccination and Post-Exposure Evaluation and
Follow-up, and (g) (1) Labels and Signs, shall take effect July
6, 1992.
Appendix A to Section 1910.1030 -- Hepatitis B Vaccine
Declination (Mandatory)
I understand that due to my occupational exposure to blood or
other potentially infectious materials I may be at risk of
acquiring hepatitis B virus (HBV) infection. I have been given
the opportunity to be vaccinated with hepatitis B vaccine, at no
charge to myself. However, I decline hepatitis B vaccination at
this time. I understand that by declining this vaccine, I
continue to be at risk of acquiring hepatitis B, a serious
disease. If in the future I continue to have occupational
exposure to blood or other potentially infectious materials and I
want to be vaccinated with hepatitis B vaccine, I can receive the
vaccination series at no charge to me.
(Approved by the Office of Management and Budget under control
number 1218-0180), (56 FR 64175, Dec. 6, 1991, as amended at 57
FR 12717, Apr. 13, 1992; 57 FR 29206, July 1, 1992)