Standards for Bloodborne Pathogens
In 1991, the Occupational Safety and Health Administration
(OSHA) promulgated the Occupational
Exposure to Bloodborne Pathogens Standard . This standard is
designed to protect approximately 5.6 million workers in the healthcare
and related occupations from the risk of exposure to bloodborne pathogens,
such as the Human Immunodeficiency Virus (HIV) and the Hepatitis B Virus
The Bloodborne Pathogens Standard
has numerous requirements, including the development of an Exposure
Control Plan. The Standard
also includes rules specific to certain types of wastes generated at
healthcare facilities, termed “regulated waste.” Regulated
waste includes blood and items contaminated with blood or other potentially
infectious materials (OPIM). This section of the Center contains
a summary of OSHA Bloodborne Pathogens Standards relating to regulated
- What is an Exposure Control Plan
- What does OSHA mean
by the term "regulated
- Management of Sharps
- How should sharps containers be handled?
- Where should sharps containers be located?
- What type of container
should be purchased to dispose of sharps?
- Disposal of Regulated
- How do I dispose of regulated waste?
- Communication of Hazard
- When are labels required?
- What are the required colors for the labels?
- Can there be substitutes for the labels?
- What are the exceptions to the labeling requirement?
- Does OSHA accept Department of Transportation's
(DOT) labels for waste and specimens which will be shipped or
- Which employees must be trained?
- Should part-time and temporary employees be
- Who has the responsibility for training workers
employed by agencies which provide personnel (e.g., nurses) to
- What are the qualifications that a person
must possess in order to conduct employee training regarding
- Where could information be obtained for conducting
training on the Bloodborne Pathogens Standard?
- Who are some examples of persons who could
conduct training on the bloodborne standard?
- OSHA State Tool
What is an Exposure Control Plan?
The exposure control plan is the employer's written program
that outlines the protective measures an employer will take to eliminate
or minimize employee exposure to blood and OPIM.
The exposure control plan must contain at a minimum:
- an exposure determination which identifies job classifications
and, in some cases, tasks and procedures where there is occupational
exposure to blood and OPIM;
- procedures for evaluating the circumstances surrounding
an exposure incident; and
- a schedule of how and when other provisions of the
standard will be implemented, including methods of compliance, communication
of hazards to employees, and recordkeeping.
What does OSHA
mean by the term "regulated
The Bloodborne Pathogens Standard uses the term, "regulated
waste," to refer to the following categories of waste:
- liquid or semi-liquid blood or other potentially
infectious materials (OPIM);
- items contaminated with blood or OPIM and which
would release these substances in a liquid or semi-liquid state if
- items that are caked with dried blood or OPIM and
are capable of releasing these materials during handling;
- contaminated sharps; and
- pathological and microbiological wastes containing
blood or OPIM.
It is the employer's responsibility
to determine the existence of regulated waste. This determination should not based
on actual volume of blood, but rather on the potential to release blood,
(e.g., when compacted in the waste container). If an OSHA inspector
determines that sufficient evidence of regulated waste exists, either
through observation, (e.g., a pool of liquid in the bottom of a container,
dried blood flaking off during handling), or based on employee interviews,
citations may be issued.
OSHA has provided some
additional guidance for the determination of regulated waste. OSHA stated that bandages which
are not saturated to the point of releasing blood or OPIM if compressed
would not be considered as regulated waste. Similarly, discarded
feminine hygiene products do not normally meet the criteria for regulated
waste as defined by the standard. Beyond these guidelines, it is
the employer's responsibility to determine the existence of regulated
BACK TO TOP
Management of Sharps
How should sharps containers be handled?
Each sharps container must either be labeled with the universal
biohazard symbol and the word "biohazard" or be color-coded
red. Sharps containers must be maintained upright throughout use,
replaced routinely, and not be allowed to overfill. Also, the containers
- Closed immediately prior to removal or replacement
to prevent spillage or protrusion of contents during handling, storage,
transport, or shipping;
- Placed in a secondary container if leakage
is possible. The second container must be:
- Constructed to contain all contents and prevent
leakage during handling, storage, transport, or shipping; and
- Labeled or color-coded according to the standard.
- Reusable containers must
not be opened, emptied, or cleaned manually or in any other manner
that would expose employees
to the risk of percutaneous injury.
- Upon closure, duct tape may be used to secure the
lid of a sharps container, as long as the tape does not serve as the
Where should sharps containers be located?
Sharps containers must be easily accessible to employees and
located as close as feasible to the immediate area where sharps are used
(e.g., patient care areas).
In areas, such as correctional
facilities and psychiatric units, there may be difficulty placing sharps
containers in the immediate
use area. If a mobile cart is used in these areas, an alternative
would be to lock the sharps container in the cart.
What type of container should be purchased
to dispose of sharps?
Sharps containers are made from a variety of products from cardboard
to plastic. As long as they meet the definition of a sharps container
(i.e., containers must be closable, puncture resistant, leak proof on
sides and bottom, and labeled or color-coded), OSHA would consider them
to be of an acceptable composition.
How do I dispose of regulated waste?
Disposal of all regulated waste must be in accordance with applicable
state regulations. These rules are typically published by state
environmental agencies and/or state departments of health (Go
to Regulated Medical Waste Locator ).
In addition to state rules
for disposing of regulated waste, there are basic OSHA requirements
that protect workers. The
OSHA rules state that regulated waste must be placed in containers which
- Constructed to contain all contents and prevent
leakage of fluids during handling, storage, transport or shipping;
- Labeled or color-coded in accordance with the standard;
- Closed prior to removal to prevent spillage or protrusion
of contents during handling, storage, transport, or shipping.
- If outside contamination of the regulated waste
container occurs, it must be placed in a second container meeting the
OSHA has no specific requirement
for hospitals or other healthcare facilities to treat (e.g., autoclave)
waste before disposal. Such
rules are usually published by state agencies ( Go
to Regulated Medical Waste Locator ).
Communication of Hazard
When are labels required?
A warning label that includes the universal biohazard symbol,
followed by the term "biohazard," must be included on bags/containers
of regulated waste , on bags/containers of contaminated laundry, on refrigerators
and freezers that are used to store blood or OPIM, and on bags/containers
used to store, dispose of, transport, or ship blood or OPIM (e.g., specimen
containers). In addition, contaminated equipment which is to be
serviced or shipped must have a readily observable label attached which
contains the biohazard symbol and the word "biohazard" along
with a statement relating which portions of the equipment remain contaminated
What are the required colors for the labels?
The background must be fluorescent orange or orange-red or predominantly
so, with symbols and lettering in a contrasting color. The label must
be either an integral part of the container or affixed as close as feasible
to the container by a string, wire, adhesive, or other method to prevent
its loss or unintentional removal.
Can there be substitutes for the labels?
Yes. Red bags or red containers may be substituted for the biohazard
What are the exceptions to the labeling requirement?
Labeling is not required for:
- Regulated waste that has been decontaminated.
- Containers of blood, blood components, and blood
products bearing an FDA required label that have been released for
transfusion or other clinical uses.
- Individual containers of blood or OPIM that are
placed in secondary labeled containers during storage, transport, shipment,
- Specimen containers, if the facility uses Universal
Precautions when handling all specimens, the containers are recognizable
as containing specimens, and the containers remain within the facility.
*(see note below concerning specimen bags)
- Laundry bags or containers, containing contaminated
laundry, may be marked with an alternative label or color-coded provided
the facility uses Universal Precautions for handling all soiled laundry
and the alternative marking permits all employees to recognize the
containers as requiring compliance with Universal Precautions. If contaminated
laundry is sent off-site for cleaning to a facility which does not
use Universal Precautions in the handling of all soiled laundry, it
must be placed in a bag or container which is red in color or labeled
with the biohazard label described above.
*A note concerning Specimen Bags: Some
healthcare facilities use plastic bags to transport specimen containers
from patient care areas to in-house laboratories. The healthcare facilities
label the plastic bag "biohazard" and dispose of the plastic
bag as infectious waste.
If not contaminated, the
plastic transport bags are not considered infectious waste and may
be disposed of as solid waste.
However, if the bags are labeled "biohazard," healthcare facilities
run the risk that the solid waste hauler might refuse to transport the
waste because of the belief that the bags are infectious.
Biohazard labeled plastic bags used as secondary containment
for internal transport of specimens is not required by OSHA. The labeling
exemption, listed in 29
CFR 1910.1030 (d)(2)(xii)(A) of the Occupational Exposure to Bloodborne
Pathogens, applies to facilities that handle all specimens with Universal
Precautions, provided the containers are recognizable as containing specimens.
The exemption applies only while these specimens remain within the facility.
If the specimens leave the facility, a label or red color-coding is required.
In addition, secondary containers or bags are only required if the primary
container is contaminated on the outside.
Does OSHA accept Department of Transportation's
(DOT) labels for waste and specimens which will be shipped or transported?
The labeling requirements do not preempt either the U.S. Postal
Service labeling requirements (39 CFR Part III) or the Department of
Transportation's Hazardous Materials Regulations (49 CFR Parts 171-181).
DOT labeling is required
on some transport containers (i.e., those containing "known infectious substances").
It is not required on all containers for which 29 CFR 1910.1030 requires
the biohazard label. Where there is an overlap between the OSHA-mandated
label and the DOT-required label, the DOT label will be considered acceptable
on the outside of the transport container provided the OSHA-mandated
label appears on any internal containers which may be present. Containers
serving as collection receptacles within a facility must bear the OSHA
label since these are not covered by the DOT requirements.
Which employees must be trained?
All employees with occupational exposure must receive initial
and annual training.
Should part-time and temporary employees be
Part-time and temporary employees are covered and are also to
be trained on company time.
Who has the responsibility for training workers
employed by agencies which provide personnel (e.g., nurses) to other
OSHA considers personnel providers, who send their own employees
to work at other facilities, to be employers whose employees may be exposed
to hazards. Since personnel providers maintain a continuing relationship
with their employees, but another employer (your client) creates and
controls the hazard, there is a shared responsibility for assuring that
your employees are protected from workplace hazards. The client employer
has the primary responsibility for such protection, but the "lessor
employer" likewise has a responsibility under the Occupational Safety
and Health Act.
In the context of OSHA's standard on Bloodborne Pathogens,
the personnel provider would be required to provide the general training
outlined in the standard, the client employer would be responsible for
providing site-specific training.
The contract between the personnel provider and the client should clearly describe
the training responsibilities of both parties in order to ensure that all training
requirements of the standard are met.
What are the qualifications that a person must
possess in order to conduct employee training regarding bloodborne
The person conducting the training is required to be knowledgeable
in the subject matter covered by the elements in the training program
and be familiar with how the course topics apply to the workplace that
the training will address. The trainer must demonstrate expertise in
the area of occupational hazards of bloodborne pathogens.
Where could information be obtained for conducting training on the
Bloodborne Pathogens Standard?
OSHA's Office of Information and Consumer Affairs (OICA) has developed
brochures, factsheets, and a videotape on the standard. Single copies of the
brochure and factsheets can be obtained by writing OSHA Publications, 200 Constitution
Avenue, NW, Room N3101, Washington, DC 20210 or by calling (202) 219-8148 the
videotape is available through the National Audio Visual Center, and the number
is (301) 763-1896. All information available through OICA should be used as
a supplement to the employer's training program. Other sources of information
include local Area and Regional OSHA Offices. In addition, each Regional Office
has a Bloodborne Pathogens Coordinator who answers compliance and related questions
on the standard.
Who are some examples of persons who could
conduct training on the bloodborne standard?
Examples of health care professionals include infection control
practitioners, nurse practitioners, and registered nurses. Non-health
care professionals include industrial hygienists, epidemiologists or
professional trainers, provided that they can demonstrate evidence of
specialized training in the area of bloodborne pathogens.
OSHA State Tool
Occupational safety and health rules in the U.S. are
mostly standardized, because:
The federal Occupational Health and Safety Administration
(OSHA) operate the primary job safety and health program in twenty-nine
(29) of the fifty states. This includes conducting inspections and enforcing
Twenty-one states (21) operate
their own job safety and health programs (three additional states cover
only state and local
government employees). States with approved programs must set job safety
and health standards that are "at least as effective as" comparable
federal standards. In most cases, states adopt standards identical to
Consultation services are
available in every state. In
most cases, these are free and are conducted at your healthcare facility. These
services help employers identify and correct workplace hazards and can
help you avoid violations and penalties.
Use the OSHA State Tool for more information on OSHA regulations and consultation
programs in your state.