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Text of the
Bloodborne Pathogens Standard 1910.1030
(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 materials.
"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.
(c)(1) Exposure Control Plan.
(c)(1)(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.
(c)(1)(ii)
The
Exposure Control Plan shall contain at least the following elements:
c)(1)(ii)(A ) The exposure determination required by
paragraph (c)(2),
(c)(1)(ii)(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)(1)(ii)(C) The procedure for the evaluation of
circumstances surrounding exposure incidents as required by paragraph (f)(3)(i) of this
standard.
(c)(1)(iii) Each employer shall ensure that a copy
of the Exposure Control Plan is accessible to employees in accordance with 29 CFR
1910.1020(e).
(c)(1)(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.
(c)(1)(v) The Exposure Control
Plan shall be made available to the Assistant Secretary and the Director upon request for
examination and copying.
(c)(2) Exposure Determination.
(c)(2)(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:
(c)(2)(i)(A) A list of all job classifications in
which all employees in those job classifications have occupational exposure;
(c)(2)(i)(B) A
list of job classifications in which some employees have occupational exposure, and
(c)(2)(i)(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.
(c)(2)(ii) This exposure determination shall be
made without regard to the use of personal protective equipment.
(d) Methods of Compliance.
(d)(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.
(d)(2) Engineering and Work Practice Controls.
(d)(2)(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.
(d)(2)(ii)
Engineering
controls shall be examined and maintained or replaced on a regular schedule to ensure
their effectiveness.
(d)(2)(iii)
Employers
shall provide handwashing facilities which are readily accessible to employees.
(d)(2)(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.
(d)(2)(v) Employers shall ensure
that employees wash their hands immediately or as soon as feasible after removal of gloves
or other personal protective equipment.
(d)(2)(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.
(d)(2)(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.
(d)(2)(vii)(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.
(d)(2)(vii)(B) Such
bending, recapping or needle removal must be accomplished through the use of a mechanical
device or a one-handed technique.
(d)(2)(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:
(d)(2)(viii)(A) puncture
resistant;
(d)(2)(viii)(B) labeled
or color-coded in accordance with this standard;
(d)(2)(viii)(C) leakproof
on the sides and bottom; and
(d)(2)(viii)(D) in
accordance with the requirements set forth in paragraph
(d)(4)(ii)(E) for reusable sharps.
(d)(2)(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.
(d)(2)(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.
(d)(2)(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.
(d)(2)(xii)
Mouth
pipetting/suctioning of blood or other potentially infectious materials is prohibited.
(d)(2)(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.
(d)(2)(xiii)(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.
(d)(2)(xiii)(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.
(d)(2)(xiii)(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.
(d)(2)(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.
(d)(2)(xiv)(A) A
readily observable label in accordance with paragraph (g)(1)(i)(H) shall be attached to
the equipment stating which portions remain contaminated.
(d)(2)(xiv)(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.
(d)(3) Personal Protective
Equipment.
(d)(3)(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.
(d)(3)(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 occurrences in the future.
(d)(3)(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.
(d)(3)(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.
(d)(3)(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.
(d)(3)(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.
(d)(3)(vii)
All
personal protective equipment shall be removed prior to leaving the work area.
(d)(3)(viii) When
personal protective equipment is removed it shall be placed in an appropriately designated
area or container for storage, washing, decontamination or disposal.
(d)(3)(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.
(d)(3)(ix)(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.
(d)(3)(ix)(B) Disposable
(single use) gloves shall not be washed or decontaminated for re-use.
(d)(3)(ix)(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)(3)(ix)(D) If
an employer in a volunteer blood donation center judges that routine gloving for all
phlebotomies is not necessary then the employer shall:
(d)(3)(ix)(D)(1) Periodically
reevaluate this policy;
(d)(3)(ix)(D)(2) Make
gloves available to all employees who wish to use them for phlebotomy;
(d)(3)(ix)(D)(3) Not
discourage the use of gloves for phlebotomy; and
(d)(3)(ix)(D)(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.
(d)(3)(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.
(d)(3)(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.
(d)(3)(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, orthopaedic surgery).
(d)(4) Housekeeping.
(d)(4)(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.
(d)(4)(ii)
All
equipment and environmental and working surfaces shall be cleaned and decontaminated after
contact with blood or other potentially infectious materials.
(d)(4)(ii)(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.
(d)(4)(ii)(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.
(d)(4)(ii)(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)(4)(ii)(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.
(d)(4)(ii)(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.
(d)(4)(iii)
Regulated
Waste.
(d)(4)(iii)(A) Contaminated
Sharps Discarding and Containment.
(d)(4)(iii)(A)(1) Contaminated
sharps shall be discarded immediately or as soon as feasible in containers that are:
[a] Closable;
[b] Puncture resistant;
[c] Leakproof on sides and bottom; and
[d] Labeled or color-coded in accordance with paragraph (g)(1)(i) of
this standard.
(d)(4)(iii)(A)(2) During
use, containers for contaminated sharps shall be:
[a] 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);
[b] Maintained upright throughout use; and
[c] Replaced routinely and not be allowed to overfill.
(d)(4)(iii)(A)(3) When
moving containers of contaminated sharps from the area of use, the containers shall be:
[a] Closed immediately prior to removal or replacement to prevent
spillage or protrusion of contents during handling, storage, transport, or shipping;
[b] Placed in a secondary container if leakage is possible. The second
container shall be:
[i] Closable;
[ii] Constructed to contain all contents and prevent leakage during
handling, storage, transport, or shipping; and
[iii] Labeled or color-coded according to paragraph (g)(1)(i) of this
standard.
(d)(4)(iii)(A)(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.
(d)(4)(iii)(B) Other
Regulated Waste Containment.
(d)(4)(iii)(B)(1) Regulated
waste shall be placed in containers which are:
[a] Closable;
[b] Constructed to contain all contents and prevent leakage of fluids
during handling, storage, transport or shipping;
[c] Labeled or color-coded in accordance with paragraph (g)(1)(i) this
standard; and
[d] Closed prior to removal to prevent spillage or protrusion of
contents during handling, storage, transport, or shipping.
(d)(4)(iii)(B)(2) If
outside contamination of the regulated waste container occurs, it shall be placed in a
second container. The second container shall be:
[a] Closable;
[b] Constructed to contain all contents and prevent leakage of fluids
during handling, storage, transport or shipping;
[c] Labeled or color-coded in accordance with paragraph (g)(1)(i) of
this standard; and
[d] Closed prior to removal to prevent spillage or protrusion of
contents during handling, storage, transport, or shipping.
(d)(4)(iii)(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.
(d)(4)(iv)
Laundry.
(d)(4)(iv)(A) Contaminated
laundry shall be handled as little as possible with a minimum of agitation.
(d)(4)(iv)(A)(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.
(d)(4)(iv)(A)(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.
(d)(4)(iv)(A)(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.
(d)(4)(iv)(B) The
employer shall ensure that employees who have contact with contaminated laundry wear
protective gloves and other appropriate personal protective equipment.
(d)(4)(iv)(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).
(e) HIV and HBV Research
Laboratories and Production Facilities.
(e)(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.
(e)(2) Research laboratories
and production facilities shall meet the following criteria:
(e)(2)(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.
(e)(2)(ii)
Special
Practices
(e)(2)(ii)(A) Laboratory
doors shall be kept closed when work involving HIV or HBV is in progress.
(e)(2)(ii)(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.
(e)(2)(ii)(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.
(e)(2)(ii)(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)(2)(ii)(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.
(e)(2)(ii)(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.
(e)(2)(ii)(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.
(e)(2)(ii)(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.
(e)(2)(ii)(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.
(e)(2)(ii)(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.
(e)(2)(ii)(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.
(e)(2)(ii)(L) A
spill or accident that results in an exposure incident shall be immediately reported to
the laboratory director or other responsible person.
(e)(2)(ii)(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.
(e)(2)(iii)
Containment
Equipment.
(e)(2)(iii)(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.
(e)(2)(iii)(B) Biological
safety cabinets shall be certified when installed, whenever they are moved and at least
annually.
(e)(3) HIV and HBV research
laboratories shall meet the following criteria:
(e)(3)(i) Each laboratory shall
contain a facility for hand washing and an eye wash facility which is readily available
within the work area.
(e)(3)(ii)
An
autoclave for decontamination of regulated waste shall be available.
(e)(4) HIV and HBV production
facilities shall meet the following criteria:
(e)(4)(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.
(e)(4)(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.
(e)(4)(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.
(e)(4)(iv)
Access
doors to the work area or containment module shall be self-closing.
(e)(4)(v) An autoclave for
decontamination of regulated waste shall be available within or as near as possible to the
work area.
(e)(4)(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).
(e)(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.
(f)(1) General.
(f)(1)(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.
(f)(1)(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:
(f)(1)(ii)(A) Made
available at no cost to the employee;
(f)(1)(ii)(B) Made
available to the employee at a reasonable time and place;
(f)(1)(ii)(C) Performed
by or under the supervision of a licensed physician or by or under the supervision of
another licensed healthcare professional; and
(f)(1)(ii)(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).
(f)(1)(iii)
The
employer shall ensure that all laboratory tests are conducted by an accredited laboratory
at no cost to the employee.
(f)(2) Hepatitis B Vaccination.
(f)(2)(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.
(f)(2)(ii)
The
employer shall not make participation in a prescreening program a prerequisite for
receiving hepatitis B vaccination.
(f)(2)(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.
(f)(2)(iv)
The
employer shall assure that employees who decline to accept hepatitis B vaccination offered
by the employer sign the statement in Appendix A.
(f)(2)(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).
(f)(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:
(f)(3)(i) Documentation of the
route(s) of exposure, and the circumstances under which the exposure incident occurred;
(f)(3)(ii)
Identification
and documentation of the source individual, unless the employer can establish that
identification is infeasible or prohibited by state or local law;
(f)(3)(ii)(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.
(f)(3)(ii)(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.
(f)(3)(ii)(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.
(f)(3)(iii)
Collection
and testing of blood for HBV and HIV serological status;
(f)(3)(iii)(A) The
exposed employee's blood shall be collected as soon as feasible and tested after consent
is obtained.
(f)(3)(iii)(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.
(f)(3)(iv)
Post-exposure
prophylaxis, when medically indicated, as recommended by the U.S. Public Health Service;
(f)(3)(v) Counseling; and
(f)(3)(vi)
Evaluation
of reported illnesses.
(f)(4) Information Provided to
the Healthcare Professional.
(f)(4)(i) The employer shall
ensure that the healthcare professional responsible for the employee's Hepatitis B
vaccination is provided a copy of this regulation.
(f)(4)(ii)
The
employer shall ensure that the healthcare professional evaluating an employee after an
exposure incident is provided the following information:
(f)(4)(ii)(A) A
copy of this regulation;
(f)(4)(ii)(B) A
description of the exposed employee's duties as they relate to the exposure incident;
(f)(4)(ii)(C) Documentation
of the route(s) of exposure and circumstances under which exposure occurred;
(f)(4)(ii)(D) Results
of the source individual's blood testing, if available; and
(f)(4)(ii)(E) All
medical records relevant to the appropriate treatment of the employee including
vaccination status which are the employer's responsibility to maintain.
(f)(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.
(f)(5)(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.
(f)(5)(ii)
The
healthcare professional's written opinion for post-exposure evaluation and follow-up shall
be limited to the following information:
(f)(5)(ii)(A) That
the employee has been informed of the results of the evaluation; and
(f)(5)(ii)(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.
(f)(5)(iii)
All other
findings or diagnoses shall remain confidential and shall not be included in the written
report.
(f)(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.
(g)(1) Labels and Signs.
(g)(1)(i) Labels.
(g)(1)(i)(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).
(g)(1)(i)(B) Labels
required by this section shall include the following legend:
BIOHAZARD
(For Illustration, of Biohazard symbol, Click Here)
(g)(1)(i)(C) These
labels shall be fluorescent orange or orange-red or predominantly so, with lettering and
symbols in a contrasting color.
(g)(1)(i)(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.
(g)(1)(i)(E) Red
bags or red containers may be substituted for labels.
(g)(1)(i)(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)(1)(i)(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.
(g)(1)(i)(H) Labels
required for contaminated equipment shall be in accordance with this paragraph and shall
also state which portions of the equipment remain contaminated.
(g)(1)(i)(I) Regulated
waste that has been decontaminated need not be labeled or color-coded.
(g)(1)(ii)
Signs.
(g)(1)(ii)(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:
BIOHAZARD
(For Illustration, of Biohazard symbol, Click Here)
(Name of the Infectious Agent)
(Special requirements for entering the area)
(Name, telephone number of the laboratory director or other
responsible person.)
(g)(1)(ii)(B) These
signs shall be fluorescent orange-red or predominantly so, with lettering and symbols in a
contrasting color.
(g)(2) Information and
Training.
(g)(2)(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.
(g)(2)(ii)
Training
shall be provided as follows:
(g)(2)(ii)(A) At
the time of initial assignment to tasks where occupational exposure may take place;
(g)(2)(ii)(B) Within
90 days after the effective date of the standard; and
(g)(2)(ii)(C) At
least annually thereafter.
(g)(2)(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.
(g)(2)(iv)
Annual
training for all employees shall be provided within one year of their previous training.
(g)(2)(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.
(g)(2)(vi)
Material
appropriate in content and vocabulary to educational level, literacy, and language of
employees shall be used.
(g)(2)(vii)
The
training program shall contain at a minimum the following elements:
(g)(2)(vii)(A) An
accessible copy of the regulatory text of this standard and an explanation of its
contents;
(g)(2)(vii)(B) A
general explanation of the epidemiology and symptoms of bloodborne diseases;
(g)(2)(vii)(C) An
explanation of the modes of transmission of bloodborne pathogens;
(g)(2)(vii)(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;
(g)(2)(vii)(E) An
explanation of the appropriate methods for recognizing tasks and other activities that may
involve exposure to blood and other potentially infectious materials;
(g)(2)(vii)(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)(2)(vii)(G) Information
on the types, proper use, location, removal, handling, decontamination and disposal of
personal protective equipment;
(g)(2)(vii)(H) An
explanation of the basis for selection of personal protective equipment;
(g)(2)(vii)(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;
(g)(2)(vii)(J) Information
on the appropriate actions to take and persons to contact in an emergency involving blood
or other potentially infectious materials;
(g)(2)(vii)(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;
(g)(2)(vii)(L) Information
on the post-exposure evaluation and follow-up that the employer is required to provide for
the employee following an exposure incident;
(g)(2)(vii)(M) An
explanation of the signs and labels and/or color coding required by paragraph (g)(1); and
(g)(2)(vii)(N) An
opportunity for interactive questions and answers with the person conducting the training
session.
(g)(2)(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.
(g)(2)(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.
(g)(2)(ix)(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.
(g)(2)(ix)(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.
(g)(2)(ix)(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.
(h)(1) Medical Records.
(h)(1)(i) The employer shall
establish and maintain an accurate record for each employee with occupational exposure, in
accordance with 29 CFR 1910.1020.
(h)(1)(ii)
This record
shall include:
(h)(1)(ii)(A) The
name and social security number of the employee;
(h)(1)(ii)(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);
(h)(1)(ii)(C) A
copy of all results of examinations, medical testing, and follow-up procedures as required
by paragraph (f)(3);
(h)(1)(ii)(D) The
employer's copy of the healthcare professional's written opinion as required by paragraph
(f)(5); and
(h)(1)(ii)(E) A
copy of the information provided to the healthcare professional as required by paragraphs
(f)(4)(ii)(B)(C) and (D).
(h)(1)(iii)
Confidentiality.
The employer shall ensure that employee medical records required by paragraph (h)(1) are:
(h)(1)(iii)(A) Kept
confidential; and
(h)(1)(iii)(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.
(h)(1)(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 1910.1020.
(h)(2) Training Records.
(h)(2)(i) Training records shall
include the following information:
(h)(2)(i)(A) The
dates of the training sessions;
(h)(2)(i)(B) The
contents or a summary of the training sessions;
(h)(2)(i)(C) The
names and qualifications of persons conducting the training; and
(h)(2)(i)(D) The
names and job titles of all persons attending the training sessions.
(h)(2)(ii)
Training
records shall be maintained for 3 years from the date on which the training occurred.
(h)(3) Availability.
(h)(3)(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.
(h)(3)(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.
(h)(3)(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
1910.1020.
(h)(4) Transfer of Records.
(h)(4)(i) The employer shall
comply with the requirements involving transfer of records set forth in 29 CFR
1910.1020(h).
(h)(4)(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.
(i)(1) Effective Date. The
standard shall become effective on March 6, 1992.
(i)(2) The Exposure Control
Plan required by paragraph (c) of this section shall be completed on or before May 5,
1992.
(i)(3) Paragraph (g)(2)
Information and Training and (h) Recordkeeping shall take effect on or before June 4,
1992.
(i)(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.
[56 FR 64004, Dec. 06, 1991, as amended at 57 FR 12717, April 13, 1992;
57 FR 29206, July 1, 1992; 61 FR 5507, Feb. 13, 1996]
OSHA Regulations (Standards - 29 CFR)
Hepatitis B Vaccine Declination (Mandatory) - 1910.1030 App A
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.
[56 FR 64004, Dec. 06, 1991, as amended at 57 FR 12717, April 13, 1992;
57 FR 29206, July 1, 1992; 61 FR 5507, Feb. 13, 1996]
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