Guidance [Feb 1993;22(2):71-91
The following recommendations cover specific ways to comply with the
standard based on information from the Occupational Safety and Health Administration
(OSHA), hospitals, and other sources. ECRI's recommendations derive, in part, from
research conducted to answer questions asked by Center for Healthcare Environmental
Management (CHEM) members. Where we have no recommendations, CHEM believes compliance is
Multiemployer Work Sites
Most hospitals are multiemployer work sites.
Physicians maintain offices at the hospital, sometimes staffed with their own
employees; surgeons are often not employees of the hospital; and many other
services, such as security and laundry, are often performed by contract
personnel. Just who is responsible for compliance at multiemployer work sites is
a valid question.
In its compliance instruction (CPL
2-2.44C:7), OSHA issues the following guidelines for multiemployer work
- "Employers shall be cited for violations of
the standard to which their own employees are exposed." OSHA is clear
that the employer, not the facility, is responsible for compliance.
Therefore, if a physician maintains an office in a hospital and staffs that
office with his or her own personnel, the physician is responsible for
compliance with any applicable provisions of the standard.
- "[Employers] shall also be cited for
violations to which employees of other employers on their premises are
exposed to the extent that they control the hazard. For example, they shall
be cited for not providing [personal protective equipment—PPE] to
unprotected employees of other employers on their premises." However,
even though the employer is primarily responsible for compliance, the
facility is not excused from responsibility when it has the power to prevent
exposure. This case is a good example of performance-based application of
- "Physicians who are members of professional
corporations are generally considered to be employees of that corporation.
Therefore, the corporation may be cited for violations affecting those
physicians, such as failure to provide the hepatitis B vaccine. Also, the
hospitals where they work may be cited for violations to which they are
exposed." Again, the hospital has the responsibility to protect
nonemployees against exposures that are in its control. For instance, the
hospital would be required to provide surgical gowns, masks, and gloves to
- "No citation shall be issued where the only persons exposed are
physicians who are sole practitioners or partners, and thus not employees
under the Occupational Safety and Health Act."
The compliance instruction makes it clear
that employers bear the responsibility for what they can control, such as
hepatitis B vaccine or training, while the facility bears the responsibility for
controlling exposure. So, who is responsible when a nonhospital employee causes
exposure to a hospital employee? This is not a trivial question; the
circumstance arises frequently in operating rooms where surgeons, who are not
employees of the hospital, are directly responsible for injuring nurses, who are
employees of the hospital, with suture needles.
According to the compliance instruction, in
such cases, the facility would be responsible for protecting its nurses against
such exposures, which it could easily do by establishing safe needle-passing
procedures and monitoring compliance with them.
The Exposure Control Plan
Because the requirements of the bloodborne
pathogens standard are different in thrust and in legal standing from other
infection control practices, ECRI believes that the exposure control plan should
be separate from the general infection control plan, regardless of the size of
the hospital. If the plan is to serve as an effective training tool for
employees at all levels, it should not be buried within guidelines for other
procedures and practices.
ECRI recommends that copies of the plan be
kept in each department and at each nursing station. They should not be locked
in an office or a desk, but should be available to employees at any time.
Employees should not have to ask permission to review the plan. In fact, they
should be encouraged to consult the plan and to make suggestions for
ECRI's Recommendations for Creating an
Exposure Control Plan
Aside from engineering controls and hepatitis
B vaccine, much of the bloodborne pathogens standard is aimed at minimizing
exposure through commonsense work procedures. In the sections that follow, ECRI
offers specific recommended practices and procedures for various types of
routine hospital tasks. These can be codified "as is" into an exposure
control plan or adapted to meet the specific needs of the hospital.
It is important to bear in mind that the
exposure control plan must be tailored to the individual circumstances of the
facility. Although a number of generic exposure control plans are on the market,
these plans do not, in ECRI's opinion, offer much benefit.
Performing an Exposure
All personnel who are at risk of occupational
exposure are entitled to the protection of the standard (64111). ECRI does not
believe that performing an exposure determination is as formidable a task as it
would first appear. Consider these facts:
- OSHA does not require quantitative risk assessment. Exposure control
measures are not implemented according to quantified risks of exposure, but
are implemented if any chance of exposure exists. Furthermore, OSHA requires
that the exposure determination be made without
considering risk reduction due to PPE.
Therefore, hospitals just have to come up with a list of those tasks that
entail the potential for exposure to blood or other potentially infectious
- Those exposure-prone tasks are well-known. OSHA is
not requiring hospitals to dig into their operations to come up with
little-known or unsuspected sources of exposure.
- The exposure scenarios are the same from hospital to hospital. All
hospitals perform the same basic tasks: the risk of exposure from
venipuncture, surgery, or other procedures is the same for all.
The following discussion represents ECRI's
suggestions for performing exposure determinations.
Gathering Sources of Information
Using the OSHA Employment
Classification Scheme. OSHA provides some help in determining who is at
risk. To get an idea of the number of people at risk of exposure to bloodborne
pathogens and the number and type of facilities affected by the bloodborne
pathogens standard, OSHA compiled a job/exposure classification scheme. OSHA
collected its information from the Bureau of Labor Statistics, the Census
Bureau, and the Bureau of Justice Statistics; the results of its surveys are
published in Fed Regist 1991 Dec
Following are the four classifications of
workers in OSHA's scheme:
A: Workers directly involved in providing
B: Laboratory workers, emergency
responders, and fire fighters;
C: Housekeepers and janitorial workers;
D: Additional workers (e.g., health aides,
service personnel, couriers/drivers).
In CPL 2-2.44C, OSHA offers an expanded list
of jobs that might entail exposure:
- Physicians, physicians' assistants, nurses, nurse
practitioners, and other healthcare employees in clinics and physicians'
- Employees of clinical and diagnostic laboratories;
- Housekeepers in healthcare facilities;
- Personnel in hospital laundries or commercial
laundries that service healthcare or public safety institutions;
- Tissue bank personnel;
- Employees in blood banks and plasma centers who
collect, transport, and test blood;
- Employees in freestanding clinics (e.g.,
hemodialysis clinics, health maintenance organization clinics, family
- Employees in clinics in industrial, educational,
and correctional facilities (e.g., those who collect blood and clean and
- Employees assigned to provide emergency first aid;
- Dentists, dental assistants, and dental laboratory
- Staff of institutions for the developmentally
- Hospice employees;
- Home healthcare workers;
- Staff of nursing homes and long-term care
- Employees of funeral homes and mortuaries;
- HIV and HBV research laboratory and production
- Employees handling regulated waste;
- Medical equipment technicians, paramedics, and
other emergency medical service providers; and
- Fire fighters, law enforcement personnel, and correctional
For each classification within each healthcare
facility, OSHA gives the estimated number of employees and the estimated number
exposed to blood splash and splatter. OSHA estimates that Category A under
hospitals, for instance, has 1.9 million workers, with 1.6 million exposed to
splash and splatter. That's an exposure rate of 84% of all employees in those
job categories. In hospitals, the rate of exposure for other classifications is
85% for Category B and 54% for Category C; no worker population was considered
for Category D.
Hospitals should offer HBV vaccination and
other protective measures, as appropriate, to every employee in classifications
A and B. When the exposure rate is that high, no good reason exists to
discriminate by task. Classification C, on the other hand, will require more
careful consideration according to what particular materials and substances the
employees handle. With an exposure rate slightly above 50%, vaccinating every
worker would not be cost-effective. If, for instance, some workers handle only
clean or sterile supplies, facilities could determine that their exposure risk
For classification D, the news is good.
Hospitals employ a large number of workers in tasks that involve neither patient
contact nor contact with contaminated materials (such as administrative duties
or food preparation). These workers are, according to OSHA's own reckoning, not
at risk of exposure.
Gathering Information from Employees.
Hospitals can gather complete exposure information by simply asking
each employee to list assigned tasks that involve potential exposure. However,
ECRI suggests that it would be more efficient to form committees by department
to develop lists of exposure-prone tasks.
Quantitative Risk Assessment.
A simple, quantitative risk assessment can determine which tasks are
the most exposure prone. Such information could help a hospital decide which
tasks would be best suited for new engineering controls, changed procedures, and
intensive training of employees responsible for the tasks. The reporting
program, if compiled accurately, should include all injuries, whether or not
they require medical follow-up.
One tool for reporting and tracking sharp
object injuries (SOIs) and other exposure incidents is Dr. Janine Jagger's
EPINet program, which she developed in association with Becton Dickinson and
which is available through the American Hospital Association (AHA). Two incident
report formats are available, one for SOIs (including needlesticks) and one for
blood and body fluid exposures not involving SOIs.
By contrast, the OSHA 200 injury and illness
reporting form reports only those injuries that result in lost workdays or that
require medical follow-up. Even so, Form 200 is supposed to provide an
information base from which to assess risk. The Joint Commission on
Accreditation of Healthcare Organizations (JCAHO) also includes risk assessment
as one of the duties of the safety officer. Therefore, ECRI believes that it
would not be too difficult to look through several years' worth of Form 200
reports to determine which tasks present the greatest risks, either numerically
or as a percentage of procedures performed.
Hospitals can choose a range of exposure
determination methods, from the simple job classification scheme to a
comprehensive risk analysis of different tasks. A more comprehensive
determination will probably cost more in time and expenses. Yet, it could pay
off in two ways: 1) by reducing the number of employees at risk and thereby
reducing the costs of HBV vaccine and training and 2) by pinpointing those
tasks that are the most significant sources of exposure.
Making a Grid
A simple grid with exposure-prone procedures
along one axis and job classifications on the other will provide a broad picture
of a hospital's potential exposures. A list would include such exposure-prone
procedures and tasks as the following:
- Intramuscular injection,
- IV access,
- Emergency intubation,
- Use of surgical power drills and saws,
- Handling contaminated laundry,
- Assisting in surgery,
- Collecting filled sharps containers,
- Changing wound dressings, and
- Servicing contaminated equipment.
Two points on this very short list are
- The procedures do not always pose the same type of
exposure and would demand different types of controls. Therefore, each
procedure is further qualified as to the type of risk it poses, such as an
SOI (e.g., a needlestick) or splashing and splattering (contact exposure).
Some SOI risks can be reduced by engineering controls, such as
self-sheathing needles, and others by procedural changes, such as better
methods of passing needles during suturing. Some procedural changes might
reduce splashing and splattering risks, but protective clothing would more
likely provide better protection.
- The nature of the tasks, like the job classifications, can be general or
narrowly defined. Narrower definitions might provide more specific guidance
on types of exposures and protective measures that are appropriate.
An exposure-prone jobs list would include the
- Floor nurse,
- Operating room nurse,
- Operating room technician,
- Clinical engineer,
- Medical (clinical laboratory) technologist,
- Laundry worker, and
The type of exposure potential of these jobs
is not the same. Persons who handle contaminated laundry, for instance, can be
exposed both to SOIs and splashing and splattering. Biomedical technologists can
be exposed to SOIs not only from needles, but also from broken slide cover
plates or collection tubes. In addition, they can be exposed to splashing and
splattering if equipment malfunctions.
ECRI recommends the grid format as a
convenient way to record this kind of exposure information and to present an
exposure determination. The advantage of the grid is that it clearly and simply
relates exposure-prone procedures to job classifications. The grid should be
added to the exposure determination part of the exposure control plan.
Evaluating an Exposure Incident
Paragraph (f)(3)(i) of the standard requires
that the circumstances surrounding exposure incidents be evaluated. OSHA states
in the preamble that such an evaluation "could include the following
elements: an evaluation of the policies and 'failures of control' at the
time of the exposure incident; the engineering controls in place at the time of
the exposure incident; and, the work practices and protective equipment or
clothing used at the time of the exposure incident. The goal of this evaluation
is to identify and correct problems in order to prevent recurrence of similar
ECRI offers the following hypothetical
scenarios as samples of what should be considered during the exposure incident
- A nurse is stuck while disposing of a needle. Was
the exposure caused by a sharps disposal container that was too full? If so,
the waste collection schedule should come under review, as should the type
of container used. Would a transparent container that makes the fill-level
visible have prevented the injury?
- An operating room nurse is stuck by a suture needle
during closure. Was the error due to an incorrect procedure by the surgeon
or the nurse? Were forceps used? If so, were they defective or inadequate?
Would a better procedure for passing the suture needle have prevented the
- A security officer is splashed with blood while trying to restrain a
patient in the emergency room. Is the exposure incident atypical for the
hospital? Or should security guards be provided with PPE for such
circumstances? Or should security guards not be called on to restrain patients in such circumstances?
- A filled biomedical waste bag (red bag) bursts during removal, exposing
a member of the housekeeping staff to medical waste. Was the bag handled
correctly? Was something in the bag that shouldn't have been there? Was the
bag defective? Should the hospital purchase sturdier bags?
In each of these scenarios, three points are
- The procedures used to carry out the task.
- The equipment involved or that should be involved
in the incident.
- The hospital's policy.
ECRI stresses the importance of obtaining an
understanding of the practical problems and concerns of the uses of the
protective controls, procedures, and equipment involved. If failure to follow
policy, for example, is a problem, perhaps the policy has not been adequately
explained, or it may not cover all anticipated circumstances. It is not enough
to dismiss the incident simply as "failure to follow policy."
Employees who use protective measures should be included in the discussion and
review of corrective measures (e.g., by focus groups, user equipment
The section of the plan covering exposure
incident review should, in ECRI's opinion, stipulate the process for review and
the people involved in the review.
Implementing Engineering Controls
When available, engineering controls offer the
potential for the most effective exposure controls to implement and are much
easier to install compared with the effort it takes to implement procedural
Reducing Sharp Object Injuries
SOIs—which include all parenteral
injuries, such as needlesticks—are the most effective route for the
occupational transmission of bloodborne pathogens. Although some evidence
supports the possibility of transmission by mucous membrane contact, bloodborne
pathogens infect most efficiently through direct blood-to-blood contact, such as
that provided by an injury with a contaminated sharp object. Healthcare
professionals have been aware of the SOI problem for a long time, but until the
first cases of occupationally acquired HIV infection were recorded, they paid
little attention to it.
ECRI believes that two mechanisms can reduce
Use of Safety Needles. ECRI
believes that the most effective way to reduce parenteral exposure is to use
safety needle devices, such as self-sheathing needles. The efficacy of these
devices has been demonstrated. For instance, needleless IV systems have
significantly reduced injuries among nurses who perform IV insertions and
removals (Jagger 1992 [Letter]; Gartner 1992).
While it does not endorse a specific
technology, OSHA also believes that safety needle devices provide the best
protection: "Most preferable is the use of devices which offer an
alternative to needles being used to perform the procedure. Examples of such
devices include stopcocks (on-off switch), needle-protected systems or
needleless systems which can be used in place of open needles to connect
intravenous lines. Other devices which are integral to the syringe, such as
self-sheathing needles, allow both hands to remain behind the needle and require
very little manipulation to isolate the needle safely" (CPL
ECRI urges hospitals to begin substituting
safety for nonsafety devices for all devices for which a safety product is
available. However, safety products may not be available for all applications,
and some products promoted as safety devices may not be effective in preventing
needlesticks. (For a further discussion, see our articles on
needlestick-prevention devices in Health Devices
20, May 1991, and 20, December 1991; this should help hospitals begin
their own evaluations to determine which products work best for their employees
and their particular exposure circumstances.)
information about the number and rates of SOIs is hard to come by; thus, a
tracking mechanism is needed. For many years, SOIs were simply regarded as part
of healthcare work and were not reported or recorded. Today, underreporting
continues for two reasons: 1) workers are afraid of reprisals for inflicting on
management the cost of postexposure follow-up and prophylaxis, and 2) many
workers prefer to remain unaware rather than face the terrifying prospect that
they might be infected by HIV. OSHA responds to the reluctance of employees to
report exposure incidents by stating that "reporting an
exposure incident right away permits immediate medical follow-up. Early action
is crucial. Immediate intervention can forestall the development of hepatitis B
or enable the affected worker to track potential HIV infection. Prompt reporting
can also help the worker avoid spreading bloodborne infection to others"
(OSHA 1992 [Bloodborne facts: Reporting exposure incidents]).
Disposing of Safety Needles
Self-sheathing needles or any other type of
safety sharp must still be disposed of in sharps containers that meet OSHA
criteria. OSHA regards needle sheaths as temporary containers: "The needle
sheath is not to be considered a 'waste
container' because it is viewed as a temporary measure. Self-sheathing
needle products must be disposed of in a sharps container" (CPL
OSHA goes on to state that, although other
products are available that may provide some measure of safety, these devices
must still be disposed of in sharps containers because it is not possible to
guarantee their correct usage or proper functioning. (For example, some
self-sheathing devices contain a fast-curing colored liquid adhesive that is
released inside the sheath after administering a substance through the needle.
This product is intended to permanently adhere all components of the syringe
needle and needle sheath, rendering the syringe and needle assembly inoperable
and incapable of causing injury. Nevertheless, such devices must be disposed of
in sharps containers because correct usage and proper functioning cannot be
Using Recapping Devices
Although OSHA considers them engineering
controls, ECRI does not recommend these for general, hospitalwide needlestick
prevention. They may be effective in limited, specialized applications. It is
better to instill a "no-recapping consciousness" (except in limited
circumstances when it is necessary for repeated use of a needle, not for
disposal) among personnel than to provide devices to make recapping safer. In
our Special Report and Product Review, "Needlestick-prevention
Devices" (Health Devices 20, May 1991), we
noted that, in hospitals where recapping devices are provided, they are seldom
used by employees, who find them awkward to carry and inconvenient.
Handling Used Sharps
ECRI does not see a reason to distinguish
between used contaminated sharps and used decontaminated sharps. All sharps that
are not in sterile wrappers or currently being used to administer medications
should be handled as contaminated. For instance, if a laundry employee finds a
sharp in a washing machine after a wash cycle, he or she is probably correct in
assuming that the sharp has been decontaminated by the wash process. However,
ECRI advises hospitals to tell the employee to handle the sharp as any other
contaminated item and to put it into a sharps disposal container. Employees
should never have to make a decision about a sharp item found anywhere in the
Should hospitals decontaminate all used
sharps? If filled sharps containers are burned on-site, there is no reason to
disinfect them before incineration. If they are processed through a grinder,
they will be decontaminated during the destruction process. If they are boxed
and hauled to a disposal site by a licensed waste contractor, ECRI still sees no
reason to disinfect them because, as studies by the Agency for Toxic Substances
and Disease Registry (ATSDR), EPA, the Government Accounting Office (GAO), and
OTA have shown, medical waste poses little or no infectious hazard to the public
outside the hospital (ATSDR 1990; EPA 1990; GAO 1990; OTA 1989).
However, medical waste regulation is not based
on rational science, but on public pressure. And the public fears medical waste.
Consequently, Congress rushed to pass the Medical Waste Tracking Act of 1988,
and since then, most states have adopted their own medical waste regulations.
Now, many states require the decontamination of medical waste, including sharps,
before disposal in a landfill. If disinfection is required by state regulation,
used sharps will have to be chemically or heat treated. If state regulations do
not require medical waste decontamination, ECRI sees no benefit to employees or
the public from decontaminating sharps.
Use of Personal Protective Equipment
The most important item of PPE for all medical
care is gloves. By far, the hands come into contact more often with blood and
OPIM than other parts of the body. Yet, despite training, healthcare workers too
often neglect to glove for one reason or another. The best remedy for neglect is
to use "consciousness raising" tactics, such as putting up gloving
signs and posters in all patient care areas and having frequent, brief safety
meetings at which safety-related topics are discussed.
Glove quality. Glove quality is a
long-standing problem. Examination and surgical gloves must be strong enough to
withstand hard use, yet flexible and thin enough to allow for good tactile
sensation. Therein lies the problem: a significant number of holes are
introduced during the manufacturing process, and because of their thinness,
gloves frequently develop holes and/or tears during use. To compound the
problem, the number of foreign-made gloves that entered the market during the
1980s called into question manufacturing processes, quality control, and raw
Although FDA classifies gloves as Class I
devices—devices that pose little or no risk to the patient or
user—it imposed premarket approval and good manufacturing practice
requirements on glove makers after Centers for Disease Control and Prevention
(CDC) issued its recommendations for UP. FDA's acceptable quality limit for
surgical gloves is 2.5% defective and for examination gloves, 4.0% (21 C.F.R.
§ 800.20). In addition, FDA has incorporated glove-testing methods
promulgated by the American Society for Testing and Materials (ASTM).
Nevertheless, estimates of the percentages of
gloves with holes remain high, ranging anywhere from 1% to 6% for surgical
gloves and over 50% for examination gloves (DeGroot-Kosolcharoen and Jones
1989). Furthermore, the ASTM test methods leave much to be desired. The two test
standards (D3578-77 for latex exam gloves and D3577-78a for surgical gloves)
require filling the gloves with water or inflating them with air and checking
for leaks. At least one study found that the tests failed to reveal small holes
that were still large enough to admit material in the HIV size range (Carey et
Furthermore, the water-fill and inflation
tests are inadequate. Gloves are complex shapes, and the test methods fail to
create a uniform stress over their entire surface. Thus, when gloves are filled
or inflated, they are more likely to stretch and develop leaks in the palms than
in the fingers. As a result, defects in the fingers are often not revealed by
Practitioners have put forth ideas to
compensate for glove inadequacies. Two writers suggested taping gloves up to but
not including the fingertips. The tape acts as reinforcement while leaving the
fingertips sensitive (Paglia and Sommer 1989). But the most common suggestion is
double gloving. The National Committee for Clinical Laboratory Standards (NCCLS)
recommends double gloving in some circumstances (see Clinical Laboratory
Procedures, below), pointing out that, if the risk of glove failure is 1 in 100,
the risk of two gloves failing at the same time is 1 in 10,000. However, many
surgeons, as well as other healthcare professionals, assert that double gloving
reduces tactile sensitivity too much.
Compliance with the Standard. To meet the
requirements of the standard—that is, to provide PPE that fits the user
comfortably and does not hinder the performance of duties (and, furthermore,
that is accessible)—each patient care unit will have to stock a rather
large supply of gloves. While it might impose a burden on hospitals, ECRI
believes that keeping a large stock of gloves on each floor is the only way to
ensure employee safety and to comply with the standard. ECRI suggests the
- Hospitals should stock three types of surgical and
examination gloves: nonlatex or hypoallergenic gloves for employees who are
sensitive to the proteins in latex; powderless gloves for employees whose
skin reacts to talc; and regular powdered gloves for those who have no
problems with allergies or powders.
- Each type of glove should be stocked in the range
of available sizes.
- All types and sizes of gloves should be made
available in each patient care unit.
- Thought should be given to encouraging surgical
personnel to double glove. Studies have shown that double gloving tends to
reduce exposure to the hands (Gani et al. 1990; Sheeler 1990; Eckersley and
- Anesthesia personnel should be included among those
who must glove during surgery. Studies have shown that anesthesia personnel
are at higher risk of exposure from blood than from saliva (Harrison et al.
- Hospitals should consider providing industrial or safety gloves to
employees who handle contaminated laundry, which might conceal used sharps,
or who handle contaminated sharp surgical instruments postoperatively for
reprocessing. These gloves might provide additional protection against
In some hospitals, employees open surgical
suction canisters for disposing of the contents or adding blood solidifiers.
Users have been cut by sharp edges on these systems. The need for industrial or
safety gloves for this use may depend on the type of system used; users should
determine whether an alternative collection system is available that does not
pose this risk. ECRI recommends against the practice of opening suction
Other Protective Clothing
Unfortunately, penetration times for blood and
OPIM have not been calculated for most protective clothing, making it difficult
to choose protective clothing for specific exposure scenarios. Hospitals should
keep in mind that OSHA does not consider uniforms that employees wear to work as
PPE. ECRI recommends the following:
- Provide lab coats or aprons to all personnel,
uniformed or not, whose assigned duties might involve exposure to mild
splashing or splattering, such as during phlebotomy, or to samples, such as
in clinical labs.
- Require all uniformed personnel whose duties entail
possible exposure to keep a clean uniform at work in case one uniform
becomes soaked in blood or OPIM.
- Launder at the hospital any employee's personal
uniform that becomes badly contaminated with blood. ECRI defines "badly
contaminated" as contaminated to the point at which the employee or a
supervisor thinks the uniform should be removed and replaced by a clean one.
A few drops of blood on a uniform do not constitute "badly
- Handle contaminated personal uniforms with the same
procedures and precautions as other contaminated laundry.
- Provide coveralls or other complete body covering,
shoe and head coverings, and heavy utility gloves to laundry workers who
handle contaminated linens (note that, because patient linens might contain
sharps, ECRI recommends considering the use of industrial or safety gloves,
which might provide additional protection). PPE for laundry workers who work
with contaminated linens should have long sleeves. Surgical scrubs should
not be considered PPE because they do not provide soak-through protection.
- Place contaminated protective clothing that is to
be decontaminated in the same bags used for contaminated laundry and subject
it to the same procedures as any other laundry.
- Place contaminated protective clothing that is to
be discarded in medical waste "red bags."
- Discourage employees from providing their own personal protective
Housekeeping employees are exposed to blood
and OPIM when they clean up spills, clean up operating rooms and emergency
rooms, and collect contaminated waste. Therefore, hospitals should provide
housekeeping employees with fluid-resistant coveralls, aprons, or lab coats;
heavy rubber gloves; and shoe covers.
ECRI recommends the following procedures for
employees who handle regulated waste (OSHA's term for infectious waste):
- All wastes that are wet with blood or OPIM should
be placed in leakproof bags that are marked with the biohazard sign.
- Infectious waste bags should not be filled to the
point that they are stretched tight. Overfilling can cause bags to break.
- If the outside of a bag becomes contaminated, the
bag should be placed inside another bag.
- To avoid contact with sharp items in red bags,
employees should pick up bags by the top—that is, the part of the bag
that is gathered above the closure point. Employees should not carry bags in
- Filled bags should be placed on collection carts as
soon as possible. Employees should not walk any farther than necessary with
infectious waste bags. Collection carts should be brought into the room or
parked at the door of the room.
- If the outside of a bag is visibly contaminated, it should be placed
inside another bag.
ECRI recommends these procedures for cleaning
up spills of blood and OPIM:
- Make every effort to avoid contact between the
blood or OPIM and skin and clothing.
- Always wear protective equipment, including rubber
utility gloves, apron, lab coat or coveralls, and shoe covers.
- Use a mop for cleaning up spills on floors. Use a
rag only for spills on other surfaces.
- Flush mop water into a sanitary sewer as soon as
- Use disposable mop heads in operating rooms.
- Dispose of used mop heads and contaminated cleanup
rags as infectious waste in containers marked with the biohazard sign.
- Decontaminate exposed surfaces with bleach or
another disinfectant approved by the hospital.
- If protective equipment becomes soaked or covered with infectious
materials, change it for clean equipment. Dispose of contaminated equipment
as contaminated waste, or decontaminate it in an approved manner.
ECRI recommends the following procedures for
employees who handle potentially infectious waste for final disposal:
- They should wear utility gloves and coveralls.
- Contact with bags marked with the biohazard sign
should be minimized. Bags should be picked up by the top only, not held in
- Boxes and bags destined for final disposal should
not be opened.
- If the contents of a bag spill, the bag should be
picked up with a shovel or broom and long-handled dustpan and put
immediately into the incinerator, autoclave, or shipping box.
- If boxes of waste destined for disposal off-site are contaminated on the
outside, they must be put into clean boxes.
OSHA's requirements for laundry workers are
designed to protect against both needlesticks from concealed sharps and
exposures from blood-soaked linens. ECRI believes that simple, commonsense
procedures can help workers minimize contact with blood and OPIM. ECRI
recommends the following procedures to minimize exposure risks to laundry
- PPE must be worn. Protective clothing for workers
who handle contaminated laundry includes shoe covers, surgical caps, and
- If employees are splattered or splashed by
contaminated laundry, they should be provided with surgical masks and
- If PPE becomes soaked or covered with blood, it
must be changed for clean equipment as soon as possible. Contaminated
equipment should be disposed of as contaminated waste or decontaminated in
an approved manner.
- Eye protection should be decontaminated with warm
water and household bleach, followed by warm water and soap.
- Employees should handle contaminated laundry in
such a way that dripping, splashing, and splattering of blood and OPIM are
- When bed linens are wet or visibly contaminated,
they should be balled and bagged without picking them up. They should not be
held or carried in the arms.
- Contaminated laundry should not be separated from
noncontaminated laundry. All dirty patient laundry should be treated as
contaminated and placed in a bag marked with the biohazard sign at the site
where it is generated; it should not be sorted outside the laundry room.
- Employees should not reach into bags of
contaminated laundry. If dissolving bags are not used, contaminated laundry
should be emptied directly from the bag into the washing machine.
- Any sharps found in contaminated laundry or in washers should be placed
in a conveniently located sharps disposal container, which should be
replaced at regular intervals. If it becomes filled to capacity, it should
be replaced with a new container.
Dealing with the Heat Problem
Many hospital laundries are not
air-conditioned, which becomes a problem if workers are required to wear
protective clothing in the summer. Protective clothing and other protective
devices are hot and can become unbearable very quickly. Work procedures should
be developed, and perhaps engineering controls implemented, that make full-body
protective clothing unnecessary. Until such methods are available, PPE should be
Use of Dissolvable Laundry Bags
Dissolvable laundry bags are a good
engineering control to prevent exposure. But ECRI has received reports from
hospitals that the bags begin to dissolve before they are placed in the washers
if they are filled with wet laundry. Therefore, before purchase, hospitals
should test these bags by filling them with wet laundry at collection points
distant from the laundry area to determine whether, under normal work
conditions, they will hold up until placed in the washers.
Use of Outside Laundry Services
Hospitals that send their laundry to an
outside service are obligated to use correctly marked bags for contaminated
laundry. Although the standard does not stipulate any obligation further than
that, ECRI believes that it is in the hospital's best interest to ensure that
its laundry contractor provides its own employees with the proper protective
equipment, clothing, and training mandated under the standard. Those employees
of outside contractors who handle contaminated laundry should be provided with
hepatitis B vaccine at the contractor's cost.
Servicing Contaminated Medical
The standard requires that contaminated
medical equipment be decontaminated before it is sent out for servicing or is
serviced in the hospital. If the equipment cannot be decontaminated, the
hospital must tag it, and information about its contamination must be conveyed
to hospital employees, as well as to outside service representatives. Under the
standard, a hospital could be held liable for infection contracted by an
equipment repair contractor or even a manufacturer's employee who services the
Ideally, manufacturers should always include
decontamination instructions with their equipment. Unfortunately, they do not
always do this. Thus, the biomedical engineering or maintenance staff, in
conjunction with housekeeping, should develop written decontamination procedures
that cover the following:
- All equipment that is serviced by hospital
- All equipment that must be sent out, and
- All equipment that is serviced by contractors in-house.
Written procedures developed by the hospital
should include any procedures provided by manufacturers. Such procedures are
not, however, a mandatory part of the exposure control plan, but they may be
ECRI recommends that hospitals do the
- Urge manufacturers to include decontamination
procedures in their instruction manuals. Procedures should also indicate
which parts of the equipment are likely to be contaminated and define the
level of decontamination required.
- Make sure that decontamination responsibility is
spelled out in service contracts.
- Try to arrange for the manufacturer's
representatives or service contract personnel to assume responsibility for
decontaminating equipment such as centrifuges, clinical analyzers,
oxygenators, or hematology analyzers that may be difficult to decontaminate,
may not have a prescribed decontamination method, or may be damaged by an
- If manufacturers or service contractors request a waiver of liability
for contaminated equipment, submit the waiver to risk management and to the
hospital legal department for consideration.
(Also see ECRI's Health
Devices Inspection and Preventive Maintenance System "Infection
Control, Decontamination, and the Clinical Engineer" in Health Devices 18, October 1989.)
Clinical Laboratory Procedures
Causes of Exposure
One study of laboratories at the National
Institutes of Health (NIH) found high levels of exposure in general (Evans et
al. 1990). The authors attributed their findings to four causes:
- Inappropriate Behaviors. Workers routinely wore gloves when handling blood at only 33%
of the workstations monitored. Four workers were observed mouth pipetting
serum and live virus suspensions despite prohibitions against this practice
in the proposed standard and in every manual of good laboratory practice.
- High Workloads. Simple,
repetitive tasks performed under the pressure of time lead to a breakdown in
attention to precautions and safety procedures.
- Faulty Instruments.
Some instruments splattered blood about. Devices with sample containers that
have to be washed present the greatest risk.
- Faulty Technique. The authors observed blood
spills that occurred even when written procedures were followed to the
letter. Image and flow cytometric systems had the greatest frequency of
Most exposures were attributed to behaviors,
including failure to follow procedures and use of faulty technique. In light of
the potential for exposure in clinical laboratories, ECRI recommends the
- Every clinical laboratory should have a written
- Every clinical laboratory should have a manual of
standard operating procedures (SOPs);
- New employees should demonstrate proficiency in the
SOPs before beginning work;
- Employees who perform repetitive tasks should be
rotated between tasks to help prevent the negligence that comes from
- Operators of automated clinical analyzers and other
instruments should wear gloves, lab coats, and eye or face protection, as
- Wastes from analyzers should be disposed of
directly into a sanitary sewer (if permitted by local sewer authorities)
without the need for employee handling in any way;
- Blood and OPIM in collection tubes should be
discarded into appropriate rigid containers;
- Biomedical engineering or laboratory staff should
use safety precautions when checking instruments for proper function;
- Safety measures in using centrifuges should be incorporated (see our
Hazard Summary on centrifuges in Health Devices 21, December 1992); and
- Potential exposure should be an important factor in selecting equipment
According to Dr. Janine Jagger and her
colleagues, "The potential for exposure to lab specimens contaminated with
hepatitis B virus remains high, and the prevalence of HIV-contaminated specimens
continues to increase. . . . Because of the volume of blood and body fluid
specimens processed in most clinical laboratories, it is probable that a high
proportion of laboratory workers are likely to handle many HBV and HIV positive
specimens daily" (Jagger et al. 1992). The nature of that risk was analyzed
by Evans, Henderson, and Bennett, who found that "workers who process blood
from numerous donors (high workloads typically associated with diagnostic
testing) increase their risk of occupational exposures to blood-borne
pathogens" (Evans et al. 1990:426). It is not surprising, then, that
studies have found hepatitis B, as measured by antibody counts, to be unusually
prevalent among laboratory workers (Levy et al. 1977) and that laboratory
epidemics of the disease have been recorded (Pattison et al. 1974).
Clinical laboratory personnel should practice
all the engineering and work practice controls and should use the PPE employed
against exposure in other scenarios. In addition, NCCLS draft recommendations
include the following practices for laboratories.
Use of Gloves
- Laboratory workers should not cut off the tips of
gloves to increase finger sensitivity.
- Because HBV can be transferred from hand to surface
and from surface to hand, gloves should be removed before handling
telephones and any other uncontaminated equipment.
- Workers should double glove for autopsies and other procedures that
might involve gross contamination.
Use of Facial Protection
- To prevent splattering, a plastic-backed gauze pad
or a flexible plastic cap should be used to cover specimen tubes when
removing rubber stoppers. Screw-top tubes eliminate the hazard.
- Laboratory safety boxes or other types of shields
might be used for unstoppering sample tubes.
- Full face shields should be used when splattering is anticipated, such
as during autopsies.
Treatment of Skin Defects
- Water-impermeable occlusive dressings should be
used for all cuts, abrasions, dermatitis, or lesions.
- Defects on fingers can be covered by a rolled-end finger cot. For other
defects, gauze should be placed over the wound, and latex from a glove or
rubber dental dam should be placed over the gauze. The edges should be
sealed with waterproof tape, such as that used to cover vascular catheter
Encouraging Use of the Hepatitis B
The first hepatitis B vaccines were derived
from human serum. Some feared, therefore, that the vaccine could be contaminated
by HIV or HBV and that the viruses could be transmitted to those receiving the
vaccine. In light of these fears, ECRI's publication Healthcare Risk Control and other experts in hospital risk management
advocated the use of an informed consent for hepatitis B vaccine. No case of
transmission of either virus from hepatitis B vaccine has ever been reported.
Today, the situation is different because recombinant vaccines not derived from serum are available.
In light of the requirements of the standard
and the CDC's recommendations for preventing hepatitis B, ECRI advocates the
- Every hospital should begin an active campaign to
encourage employees to receive hepatitis B vaccine. Such a program should
involve the human resources department, employee health, the unions, and
- Encourage employees undergoing the vaccination
series to receive their shots on time. Because full immunity is not
conferred until the final dose is administered, employees who delay
receiving their shots are at increased risk.
- Administer postvaccination testing for antibodies
only to those persons with the greatest exposure potential, such as
operating and emergency room staff. ECRI believes this is important because
administration of hepatitis B immune globulin (HBIG) after exposure is not
reliable after seven days. Therefore, exposure of persons of unknown immune
status may not have time to be tested before the optimal prophylaxis period
- Immunize students in healthcare profession programs
as early as possible so that they will be immune before their first contact
with blood. Ideally, this should be done during the first year of medical,
nursing, dental, or other professional school.
- Immunize all laundry employees and housekeeping
personnel as soon as possible. Because of the recommended duration of the
vaccination series, it will not be possible to provide full immunity to new
workers before they start the job.
- If a large percentage of housekeeping and laundry
employees come primarily from foreign countries or territories with high
endemic rates of hepatitis B infection, prescreening them for immune status
might prove to be cost-effective.
- If an employee cannot remember whether he or she has been vaccinated and
if no medical records are available, offer the vaccine to that employee
without testing for immune status. Revaccination of an immune person has no
Vaccination of Outside Contractors
ECRI believes that outside contractors who
work in hospitals are at risk for hepatitis B infection. While it is not the
hospital's responsibility to vaccinate contractors, a hospital could possibly be
held liable for an infection incurred by a contractor. It is a good practice to
encourage (or require as a vendor qualification) contractors to provide
hepatitis B vaccine to their employees. As a matter of policy, ECRI offers
hepatitis B vaccine to its employees who spend time consulting in
Communicating Hazards to Employees
Regarding labels and signs, ECRI does not
agree with those commenters who argued that they vitiate UP. We see a parallel
between stop signs and biohazard labels: just as the presence of stop signs
doesn't mean that people will give up driving defensively, the presence of
biohazard labels doesn't mean that workers will ignore the risks of blood and
OPIM. Therefore, just as local agencies continue to put up signs at dangerous
intersections, so should hospitals continue to label hazardous materials. ECRI
advocates that all regulated waste containers be color coded and labeled. Most already come that way from suppliers.
While OSHA does not require supervised
training, ECRI believes that the most effective training is conducted with a
trainer present because of the following:
- Supervised sessions guarantee that all employees
receive equal training.
- Studies have shown, unfortunately, that a
significant percentage of the U.S. labor force has problems with reading,
writing, and using computers.
- Trainers should have the know-how to deal with
individual employee problems; neither computers nor media presentations can
offer similar flexibility and adaptability, no matter how cleverly they are
designed. Remember, OSHA requires that the training suit the employee's
language and educational background.
- Supervised training protects the hospital from the liability incurred
from employees who skip training or who have someone else complete an
unsupervised training curriculum for them.
ECRI recommends that hospitals design two
basic training curricula, one for nonprofessional staff and one for professional
staff. The two programs should differ only in the amount of information
presented, assuming that professional employees have an educational background
that will enable them to understand more about the biologic, epidemiologic, and
clinical features of bloodborne diseases. However, nonprofessional staff should
be encouraged to learn all that they wish about these diseases, and materials
and instruction should be made available to anyone who wishes to gain more
Of the nonprofessional staff, training should
be provided at least to all housekeeping, laundry, and central processing
personnel; nurses aides; and employees who handle wastes for incineration,
autoclaving, or shipping. Of professional staff, training should be provided to
all doctors and nurses, phlebotomists, laboratory employees, biomedical
engineers, and facility engineers.
A Minimal Training Syllabus
Based on OSHA's bloodborne pathogens standard,
the requirements for both training and the hospital's exposure control plan are
similar. In fact, training essentially consists of an explanation of the general
protective principles in the OSHA standard; the exposure control plan is the
facility-specific implementation of those principles. The following syllabus,
developed by ECRI, can serve as the foundation both for training employees and
for developing an exposure control plan.
The Essential Elements of Training
Once a hospital has determined that assigned
duties involve occupational exposure to blood or other potentially infectious
materials (OPIM), such as semen and amniotic fluid, a training program must be
instituted to protect employees. These substances can harbor infectious
organisms, viruses, and bacteria that can be transmitted through contact with
blood or mucous membranes, for example in the eyes, nose, or mouth. The training
session should advise employees of this risk and tell them what measures the
hospital has implemented to protect them from exposure to blood and OPIM.
The epidemiology, transmission, and clinical
presentation of bloodborne diseases must be thoroughly reviewed. The OSHA
standard definition of "exposure incident" involves a break in the
skin by a potentially contaminated item (e.g., a needle, a piece of broken
glass) or contact of mucous membranes, eyes, or nonintact skin with blood or
OPIM. If employees get blood on their skin, but the skin is not cut or
scratched, they are unlikely to become infected by a bloodborne pathogen.
Emphasis should be placed on three points:
Who gets bloodborne diseases?
Anybody can get a bloodborne disease; bloodborne diseases are not
limited to any sex, sexual behavior, or ethnic or economic group. Case reports
show that healthcare workers are by far at greater risk of acquiring
occupational hepatitis B virus (HBV) than human immunodeficiency virus (HIV),
although HIV is most often fatal.
How does someone get a bloodborne
disease? Bloodborne diseases are transmitted by contact between the
blood or body fluids of an infected person and the blood and body fluids of a
noninfected person. These diseases can be transmitted sexually through semen or
vaginal secretions, through breast milk, and through blood contact. They are
frequently transmitted among IV drug abusers by infected needles, and they can
be transmitted by a bite from an infected person.
Occupationally, the most frequent and
efficient route of transmission is through accidental needlesticks and cuts by
other sharp, contaminated objects. But pathogens are also transmitted by contact
with blood and other body fluids, such as through the nose, eyes, mouth, or cuts
or abrasions of the skin (nonintact skin). Bloodborne pathogens are not
transmitted through the air from coughing or sneezing or by casual contact with
infected individuals; however, they can be carried through the air in blood that
How do these diseases affect people?
HBV attacks the liver, causing jaundice (a yellowing of the skin),
nausea, weakness, and abdominal pain. If left untreated, hepatitis B can become
chronic and cause liver destruction, called cirrhosis; it has been linked with
HIV attacks the immune system and causes the
disease complex known as acquired immunodeficiency syndrome (AIDS). As the
immune system weakens, AIDS patients become susceptible to a wide range of
infections, which eventually kill them. Survival time from the onset of
infection to death can be as short as 2 years or as long as 10 years. To date,
no one has been known to survive AIDS.
How the Bloodborne Pathogens Standard Protects
The seriousness of bloodborne diseases and the
potential for occupational exposure prompted OSHA to enact a standard that sets
forth regulations to protect workers from exposure to bloodborne pathogens
through contact with blood or OPIM.
The standard requires hospitals to implement
eight protective measures:
- Universal Precautions (UP)—A work practice under which all blood, OPIM, and
contaminated devices are handled as if they were infectious. It is not
possible to tell whether blood is infectious without laboratory testing,
and it is often not possible to tell whether a device, such as a needle,
is contaminated. Employees should never be asked to determine whether
blood, OPIM, or medical devices are infectious—and should use UP
so that they will not have to.
- Engineering Controls—Devices that can be used to eliminate sources of
exposure. Puncture- and leak-resistant sharps disposal containers are
required; self-sheathing sharps are another control that could be used.
- Personal Protective Equipment
(PPE)—Gloves, lab coats, face shields, and other
equipment designed to protect the skin, eyes, and mucous membranes
- Work Practices and Procedures—Hand washing, removing contaminated clothing, and
other practices that minimize contact with blood and OPIM.
- Hepatitis B Vaccine—A serum that immunizes employees against HBV infection
and eliminates the threat of hepatitis B.
- Postexposure Prophylaxis and
Follow-up—Procedures that provide the best
medical help after exposure has occurred.
- Signs and Labels—Warnings used to clearly mark containers of
contaminated materials so that others are alerted to the risk.
- Training and Information—Methods of
teaching employees how to avoid exposure and what to do when exposure
The Hospital's Exposure Control
OSHA requires all employers to produce a
written exposure control plan that incorporates their specific methods of
controlling exposure based on the provisions of the standard. The plan contains
the hospital's determination of who is at risk for exposure to blood and OPIM
and describes practices and procedures applicable to all employees of the
hospital, as well as to the performance of specific duties and tasks. The plan
must be enforced by the hospital and obeyed by all employees. Copies should be
made available to employees at any time; they do not need permission to review
The plan should consist of at least the
following six measures:
Engineering Controls and Work
Practices. The rules for hand washing and other engineering controls or
work practices that affect the majority of trainees should be reviewed.
Applicable engineering controls and practices should be identified and
described, and instruction (hands-on, if possible) provided. The hospital should
verify that trainees understand both how and why they are to use the controls
and practices. In addition, the schedule for collecting sharps containers should
Signs and Labels. All OPIM or
their containers must be labeled. The exception to this is blood collection
tubes that are used by phlebotomists and seen by patients. The general meaning
of the biohazard symbol should be explained, and all items and containers that
should bear the symbol or other warning signs should be so labeled. Any
container marked with the biohazard symbol should not be used for other than its
intended purpose, such as to contain noninfectious materials or noncontaminated
items. Decontaminated items may not be put into a container bearing the
biohazard symbol. Any particular color codes used in the hospital to indicate
potentially infectious materials should be described.
Personal Protective Equipment (PPE).
Any task involving exposure to blood or OPIM requires the use of PPE,
which should be specified to meet each type of exposure. All PPE will be
provided by the hospital at no cost to employees. Methods of using articles of
PPE and removing contaminated clothing should be demonstrated, and employees
must wash their hands immediately or as soon as possible after removing PPE. PPE
must be removed at the work site; it may not be taken out of the facility.
Contaminated PPE should either be decontaminated on-site (according to the
manufacturer's instructions, by cleaning with bleach, or by laundering with
other contaminated laundry) or should be disposed of as infectious waste in a
container marked with the biohazard symbol. Personal clothes are not considered
PPE, and personal items of clothing should be protected from contamination.
Hepatitis B Vaccine. The fact
that the vaccine confers immunity from HBV infection, is 90% effective, and has
minimal side effects should be explained, as should the method of determining
who should get the vaccine. The vaccine will be provided at no cost to the
employee. The series of injections and the schedule should be
explained—the sooner employees begin their vaccination series, the sooner
they will be protected against hepatitis B infection. The OSHA declination
statement should also be presented; employees can change their minds about
vaccination at any time without penalty.
Reporting Exposure Incidents.
The hospital should stress the importance of reporting exposure
incidents and explain the reporting mechanism. Reporting an incident will not
adversely affect employment, and confidentiality of medical findings is
In the event of an exposure incident—a
penetration of the skin by a contaminated item or contact of the mucous
membrane, eye, or nonintact skin with blood or OPIM—the exposed employee
or a coworker should contact a supervisor at once. Reporting is essential so
that proper medical care can be administered. The supervisor should immediately
contact employee health services. If an exposure incident occurs when the
employee health office is closed, the number of an appropriate department should
be immediately available to obtain emergency medical help. The OSHA 200 report
should be described. Supervisors should receive training on encouraging
reporting and on handling reports.
Postexposure Prophylaxis and
Follow-up. Any employee who experiences an exposure incident will be
provided with medical surveillance and treatment (if required) at no cost to the
employee. If possible, the hospital will determine whether the substance to
which the employee was exposed is actually infectious and inform the employee of
any findings. However, patients are not obligated to report their infection
status or release such information. Any subsequent medical treatment will be
based on the opinion of the healthcare professional who is in charge of the
The employee will be informed of the results
of the postexposure evaluation. The employer is entitled to know only whether
the employee should receive HBV vaccine, has received the vaccine, and has been
informed of any medical conditions resulting from exposure. All other medical
information relating to the employee's health is confidential and will not be
revealed to the employer or anyone else not designated by the employee to review
the medical record.
Rules and procedures notwithstanding,
compliance with safe practices is ultimately the responsibility of each
individual worker. Employers can implement programs in good faith, but for
success, workers have to demonstrate good faith, as well. ECRI advocates
positive incentives to encourage employees to become more aware of risks and
safe practices in their jobs.
At APIC's 1992 meeting (San Francisco, May 31
to June 4), Gina Pugliesi of AHA gave an effective talk on motivating
compliance. Her points included the following:
- Positive incentives versus disciplinary action,
- Visible commitment by management to employee safety
- Employee input into the compliance process, and
- Role models.
ECRI believes that positive incentives are
important. Hospitals should welcome innovative suggestions for increasing
awareness among staff. They should give serious consideration to poster and
safety contests, buttons, and regular safety meetings. ECRI is aware that
hospitals have rejected such strategies as childish, or nonscientific, or not
staid enough. But they work, as general industry well knows. ECRI recommends
that hospitals take a look at the "Safety Compliance Initiative" kit
offered by Becton Dickinson, which contains materials and ideas to help get a
motivational program started.
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