Copyright 2000 Federal News Service, Inc.
Federal News Service
June 22, 2000, Thursday
SECTION: PREPARED TESTIMONY
LENGTH: 4054 words
HEADLINE:
PREPARED TESTIMONY OF CHARLES N. JEFFRESS ASSISTANT SECRETARY OCCUPATIONAL
SAFETY AND HEALTH ADMINISTRATION U.S. DEPARTMENT OF LABOR
BEFORE
THE HOUSE EDUCATION AND THE WORKFORCE COMMITTEE SUBCOMMITTEE ON
WORKFORCE PROTECTIONS
SUBJECT - "OSHA COMPLIANCE DIRECTIVE ON
ENFORCEMENT PROCEDURES FOR THE OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS"
BODY:
Mr. Chairman, Members of the
Subcommittee, thank you for inviting me to testify about the Occupational Safety
and Health Administration's (OSHA's) revised bloodborne pathogens compliance
directive. I am pleased to have this opportunity to explain the directive and to
talk about what OSHA is doing to eliminate or minimize the risk of
needlesticks and other sharps injuries, and to tell what we
learned from our Request for Information (RFI) on the current use of engineering
and work practice controls in the workplace.
Bloodborne Pathogens are a
Serious Hazard
OSHA published the final bloodborne pathogens standard in
1991 in response to the significant health risk associated with occupational
exposure to blood and other potentially infectious materials. At that time,
nearly six million workers in health care and related occupations faced exposure
to bloodborne diseases. The standard applies to employees who have occupational
exposure to the hazard, the presence of blood or other potentially infectious
materials, whether or not a needlestick injury has occurred at
the worksite. Diseases caused by bloodborne pathogens include, but are not
limited to: Hepatitis B (from the Hepatitis B virus (HBV)); Hepatitis C(from the
Hepatitis C virus (HCV)); acquired immunodeficiency syndrome (AIDS) (from the
human immunodeficiency virus (HIV)); HTLV-I-associated myelopathy (from the
human Tlymphotrophic virus Type 1 (HTLV-I)); diseases associated with HTLV-II;
and malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral
infections, relapsing fever, Creutzfeldt-Jakob (known as mad-cow) disease, and
viral hemorrhagic fever. Many of these diseases are fatal, and at the time the
standard was issued, OSHA predicted that each year the standard would prevent
5,058 - 5,781 occupational HBV infections and 113-129 Hepatitis B deaths. The
standard has been an enormous success. Since the standard was promulgated in
1991, the rate of occupationally acquired Hepatitis B infection has declined
dramatically. I believe OSHA's standard, among other factors, contributed to the
decline -- in particular the standard's requirement that employers provide and
pay for Hepatitis B vaccines for employees exposed to blood or other potentially
infectious materials. In 1987, there were 8,700 cases of Hepatitis B infection
among health care workers. In 1995, just four years after publication of OSHA's
standard, only 800 new cases related to occupational exposure were reported by
the Centers for Disease Control and Prevention (CDC).
Despite the
standard's success in addressing HBV, OSHA always has been and continues to be,
concerned about injuries from needles and other sharps that are contaminated
with blood or other potentially infectious materials, particularly in health
care settings where employees are frequently exposed to needles and sharp
instruments. Notably, needlesticks alone account for up to 80%
of the occupational exposures to blood (Jagger, J. "Rates of
needlestick injury caused by various devices in a university
hospital." New England Journal of Medicine. 319(5): 284-8; 1988). The health
research community estimates 600,000 to 800,000 needlestick
injuries occur annually -- on average that is one incident a year for every
seven health care workers. According to the CDC, about half of
needlestick injuries go unreported. CDC has stated that an
average hospital incurs approximately 30 worker needlestick
injuries per 100 beds per year. Most reported needlestick
injuries involve nursing staff. However, CDC indicates that laboratory staff,
physicians, housekeepers, dental assistants, and other health care workers have
also experienced needlestick injuries - - and are still being
injured. (National Institute of Occupational Safety and Health (NIOSH) Alert,
"Preventing Needlestick Injuries in Health Care Settings" (CDC,
1999)). Because such injuries continue to be the primary source of occupational
exposure to bloodborne pathogens, OSHA and other public health agencies are
stressing the importance of reducing these risks.
Between 1985 and
December 1999, the CDC reported 56 documented cases of occupationally acquired
HIV infections in health care workers and an additional 136 cases of possible
occupational HIV transmissions. The risk of contracting Hepatitis C, for which
there also is no vaccine, and no cure, is far greater.
Before proceeding
to discuss the risk faced by health care workers from HCV, I would like to
provide some background on this little-known disease. HCV infection often occurs
with no symptoms, or only mild symptoms. But, according to the CDC, "chronic
infection develops in 75% to 85% of patients, with active liver disease
developing in 70%. Of the patients with active liver disease, 10% to 20% develop
cirrhosis, and 1% to 5% develop liver cancer." (NIOSH Alert, "Preventing
Needlestick Injuries in Health Care Settings").
Population-based studies indicate that 40% of chronic liver disease is
HCV-related, resulting in an estimated 8,000-10,000 deaths each year. In
addition, HCV-associated end-stage liver disease is the most frequent indication
for liver transplantation among adults (MMWR October 16, 1998, Vol. 47
(RR19);139).
A health care worker's risk of exposure to HCV is much
higher than the risk of exposure to HIV. The risk is increased in part because
the frequency of HCV in the population far outstrips the frequency of HIV.
According to the CDC, 3.9 million Americans have been infected with HCV (MMWR
October 16, 1998, 1-39). In comparison, the number of people living with HIV is
estimated to be between 650,000 and 900,000 (CDC Update, "How Many People Have
HIV & AIDS," May 1999). Because more Americans have HCV than HIV, health
care workers face a greater risk of encountering a patient with HCV than a
patient with HIV. Of the total acute Hepatitis C infections that occurred in
1995, the CDC estimates that 2%-4%, or 720-1400, were in health care workers
exposed to blood in the workplace. (MMWR October 16, 1998, 1-39). Although we do
not know how many of these cases are attributable to
needlesticks or others sharps injuries, we do know that the
transmission rate for HCV percutaneous injuries is higher than that for HIV: the
CDC estimates an average transmission rate of 0.3% per injury for HIV, as
compared to an average transmission rate of 1.8% for HCV. Both this higher
transmission rate, and the higher frequency of HCV occurrence in the general
population, lead to the conclusion that health care workers face a significant
threat from HCV through needlestick and sharps injuries.
The Standard (29 CFR 1910.1030)
The bloodborne pathogens
standard contains provisions which were designed and written to be
performance-oriented. In other words, the goals of the standard are clearly
stated, yet many aspects of the rule give employers considerable flexibility in
choosing the methods most feasible for accomplishing those goals. Thus, the
standard directs employers to use engineering controls and work practices to
eliminate or minimize employee exposure to bloodborne pathogens, but it does not
list or specify particular engineering controls (such as which medical devices)
that employers must use. This approach allows the rule to take into account the
continual progress of medical research and technology and the diversity of
workplaces and workplace operations and processes, and allows the employer to
determine what engineering controls will provide the best protection.
A
central provision of the bloodborne pathogens standard clearly demonstrates its
flexible, performance-oriented nature: paragraph (c) of 29 CFR Part 1910.1030
requires employers to develop a written exposure control plan (ECP) that
addresses, among other things, the site-specific engineering, work practice, and
administrative controls the employer will use to prevent exposure to bloodborne
pathogens for workers who have an ongoing occupational risk. In other words, the
employer creates a plan that is tailored to the conditions of that employer's
work place. The ECP must also include the procedures for evaluating
circumstances surrounding an exposure incident. The ECP is used 'to identify
exposed or potentially exposed workers, i.e., those who need training, personal
protective equipment, access to vaccinations, and treatment if an exposure
incident occurs.
OSHA believes the key to preventing
needlesticks and other sharps injuries lies in a comprehensive
strategy - a programmatic approach through which employers: 1) use the ECP to
evaluate the hazards at their specific facility, 2) provide appropriate employee
training for the safe and effective use of new equipment, and 3) evaluate the
results and make changes accordingly. OSHA has found this strategy to be more
successful when employees are involved in the safer device selection process.
This overall approach is highlighted in the current compliance directive, which
I will discuss in a moment.
OSHA is Addressing the Continuing Risk
Notwithstanding the success of the standard, OSHA recognizes a need to
emphasize specifically the continuing problem of needlesticks
and other sharps injuries. Prior to OSHA's decision to revise the bloodborne
pathogens standard compliance directive, the agency received suggestions to
implement an emergency temporary standard mandating the use of safer devices,
and to reopen the bloodborne pathogens standard. Additionally, OSHA is currently
considering, as recommended by the Senate Appropriations Committee, a revision
to the recordkeeping rule to require that all exposure incidents resulting from
contaminated needles and other sharps be recorded on OSHA injuries and illnesses
logs. Of course, any new rule would be drafted with strong privacy and security
safeguards. We are also aware of other Congressional interest in this area. Last
year Senator Barbara Boxer and Representatives Pete Stark and Marge Roukema
introduced legislation entitled the "Health Care Worker
Needlestick Prevention Act" (S. 1140/H.R. 1899). The Department
of Labor expressed support for the intent of the bills in October 1999 letters
from Secretary Alexis Herman to Chairman Jim Jeffords, Senator Boxer, and
Representative Stark.
The Request for Information (RFI)
Since
the promulgation of the bloodborne pathogens standard, the agency, along with
the medical and scientific community, has been aware of the continuing problem
of needlesticks and other sharps injuries. However, concrete
data on the penetration, acceptance and effectiveness of engineered sharps
injury prevention devices were hard to collect, or even find. Therefore, in the
Spring of 1998, OSHA began developing an RFI to gather information and data from
the public. OSHA was interested in learning which strategies for reducing
injuries associated with transmission of bloodborne pathogens were being
successfully implemented in workplaces, and we asked for ideas and
recommendations on ways to better protect workers from contaminated needles or
other sharp instruments. The RFI solicited information on many aspects of
percutaneous (through the skin) injury prevention. Sixteen questions were
carefully developed to draw responses about the types of work settings where
such injuries occur; percutaneous injury surveillance; use, evaluation, and
effectiveness of control methods; and economic factors associated with the
control of needlestick and other sharps injuries. The RFI was
published in the Federal Register on September 9, 1998, with a 90-day comment
period. OSHA received 396 responses. More than 300 health care facilities
provided comments, including nursing homes and clinics; acute care, and
rehabilitation facilities, and pediatric hospitals. The Department of Veterans'
Affairs, the largest health care provider in the Nation, submitted valuable
information on its on-going needlestick prevention program.
Several organizations submitted combined responses on behalf of members
representing more than 130 additional health care facilities. Individual health
care workers, researchers, unions, educational institutions, professional and
industry associations, and manufacturers of medical devices also responded.
OSHA released a summary of the comments in May 1999. We learned three
critical things from the responses we received: 1) a variety of safer devices
were already being used in a number of workplaces to protect workers from
needlestick and sharps injuries; however, these devices were
not being used widely enough to reduce the overall risk substantially; 2)
training and education in the use of safer medical devices and safer work
practices have proven effective in preventing exposures in these workplaces; and
3) employee involvement in the selection process can play an important role in
the acceptance and proper use of safer medical devices.
"Safer devices"
refers to the new technology that has been developing in the past several years
to reduce the risk of needlesticks and other percutaneous
injuries through elimination of the sharp or incorporation of safety features
into a conventional sharp device (e.g. hypodermic syringe/needle). OSHA
encourages employers to involve employees in the selection of effective
engineering controls to improve employee acceptance of the newer devices and to
improve the quality of the selection process. Examples of this technology
include needleless devices, shielded needle devices, self-sheathing needles,
self-blunting needles, and plastic capillary tubes. There are hundreds of these
devices on the market, and this industry is constantly developing new devices.
However the design quality and practical effectiveness of the devices in
reducing injuries vary considerably.
The November 5, 1999, Compliance
Directive
Compliance directives guide OSHA's compliance officers in
enforcing standards by providing instruction and ensuring that consistent
inspection procedures are followed. OSHA recognizes that employers and other
members of the public have an interest in the guidance OSHA provides to its
compliance staff, and therefore we make such guidance documents available to the
public and post them on our website.
OSHA used a thorough and considered
review process to develop the revised directive for the bloodborne pathogens
standard. Our industrial hygienists, occupational health nurses, occupational
physicians, and public health specialists provided a wealth of professional
expertise, including wide experience in hazard control. Additionally, OSHA's
attorneys reviewed the directive for consistency with the bloodborne pathogens
standard. OSHA also drew upon almost 400 responses to the RFI and information
from experts at the CDC, the Food and Drug Administration (FDA), and the
Training for Development of Innovative Control Technology Project (TDICT).
I want to emphasize that the current directive is a restatement,
clarification and further explanation of the requirements of the bloodborne
pathogens standard. It does not amend the standard or create new legal duties,
obligations or defenses. But while the standard has not changed, control
technology and medical treatment have. In the years since the standard was
promulgated, the ability to control exposure to, and transmission of, bloodborne
pathogens has improved significantly. These developments, along with what we
learned from the RFI, provided the impetus to update the compliance directive.
There are five main areas where additional instruction has been
incorporated into the new compliance directive. These areas include: an emphasis
on the annual review of the ECP; a clarification of how employers must evaluate
and implement engineering controls; a description of necessary employee
training; new medical recommendations from the CDC; and, an explanation of the
applicability of the bloodborne pathogens standard in multi-employer
worksites.Exposure Control Plan (29 CFR 1910.1030 (c))
Under the
standard, employers must review and update their ECP at least annually, which
ensures that it remains current with the latest information and scientific
knowledge concerning bloodborne pathogens. The ECP requires the employer to
identify those tasks and procedures in which occupational exposure may occur,
the individual workers who need to receive training, protective equipment,
vaccinations and other protections of the standard, including the provision of
engineering controls. In light of the increased use and acknowledged feasibility
of safer medical devices, the ECP must document the employer's consideration and
implementation of appropriate, commercially available and effective engineering
controls. The annual review and update of the plan ensures that it, and the
employer's efforts, reflect changes in technology, such as the use of effective
engineering controls - safer medical devices - that can eliminate or minimize
employee exposures at that workplace. The current CPL includes a sample
"fill-in-the blanks" exposure control plan as an appendix.
Engineering
Controls and Work Practices (29 CFR 1910.1030 paragraph (d)(2))
Under
the standard, employers are required to institute engineering and work practice
controls as the primary means of eliminating or minimizing employee exposure.
Employers must use engineering and work practice controls that eliminate
occupational exposure or that reduce it to the lowest feasible extent. The CPL
clarifies this intent by stating that "where engineering controls will reduce
employee exposure either by removing, eliminating or isolating the hazard, they
must be used." Through the mandatory exercise of the annual review of the ECP,
employers are required to evaluate workplace exposures to bloodborne hazards and
make changes to their ECP which include the consideration and implementation of
new technology - safer medical devices and safe work practices - where feasible.
This requirement was stated in the preamble to the standard in 1991, and also
reiterated in the 1992 compliance directive. Where implementation of engineering
controls for a particular procedure are found to be infeasible, the employer
should document this in the ECP and explain why no controls could be utilized.
OSHA does not advocate the use of one particular device over another;
however, in light of the increased use and acknowledged feasibility of safer
technology, as demonstrated by the responses to OSHA's RFI, it is clear that
some form of engineering control use will be feasible to prevent or minimize
most workplace sharps exposures.
Training (29 CFR 1910.1030(g)(2))
The CPL explains that the standard requires initial and annual refresher
"interactive" training sessions where employees must be able to ask questions of
the person conducting the training, and to receive immediate answers. This type
of training may be supplemented with the use of films or videos, as long as
employees are provided an opportunity for discussion. Interactive training is
important to ensure that new devices are used correctly. Many of those who
responded to the RFI confirmed the need for effective and thorough training to
achieve successful implementation of safer medical devices.
New Medical
Information
The standard (29 CFR 1910.1030 (f)(3)(iv)) requires
employers to incorporate the medically indicated recommendations of the U.S.
Public Health Service (USPHS) for post-exposure prophylaxis and follow-up. The
CDC is the USPHS agency responsible for making these recommendations. The CPL
underscores the standard's requirement that employers use CDC guidelines current
at the time of the evaluation or procedure. The most recent CDC guidelines
included as appendices to the current CPL include: the December 26, 1997,
"Immunization of Health-Care Workers: Recommendations of the Advisory Committee
on Immunization Practices (ACIP) and the Hospital Infection Control Practices
Advisory Committee (HICPAC)" addressing Hepatitis B; the May 15, 1998, "Public
Health Service Guidelines for the Management of HealthCare Worker Exposures to
HIV and Recommendations for Post- Exposure Prophylaxis;" and the October 16,
1998, "Recommendations for Prevention and Control of Hepatitis C Virus (HCV)
Infection and HCV- Related Chronic Disease."
Multi-employer Worksites
The directive also includes instructions on inspection procedures for
multi-employer worksites, that are covered by the standard, which may involve,
for example, employment agencies, personnel services, home health services,
independent contractors, and physicians in independent practice.
Employer Assistance
In addition to the specific changes in the
new directive, I would like to describe our outreach efforts. Since the rule was
promulgated, OSHA has made available to the public a large variety of
educational materials and technical information, as well as a great deal of
guidance to assist employers in complying with the bloodborne pathogens
standard. For instance, OSHA has set up a detailed "Technical Links" webpage
that allows users to access multiple references from the CDC, the FDA, and other
recognized experts in this field such as the University of Virginia's
International Healthcare Worker Safety Center (responsible for EPINet, the
Exposure Prevention Information Network database) and TDICT. We have continued
these efforts by including several helpful resources in the appendices of the
revised compliance directive: a list of the typical committees found in health
care facilities; sample engineering control evaluation forms; a sample ECP; and
an Internet resource list.
OSHA provides additional assistance through
our ten Regional Bloodborne Pathogen Coordinators - one located in each of
OSHA's regional offices. The Coordinators may be contacted on an individual
basis whenever an employer, employee or OSHA staff person has questions. In
order to ensure OSHA's compliance personnel were aware of the new emphasis on
the importance of updating the ECP and the implementation of existing technology
as required by the engineering control sections of the standard, OSHA conducted
an all-OSHA training session in February of this year in Atlanta. Over 175
persons attended this training session. Attendees included compliance officers
from across the country, Regional Bloodborne Pathogens Coordinators, State Plan
personnel, and representatives from OSHA's Consultation programs. It is
important for OSHA's Consultation staff to know how OSHA enforces the rule, so
that they can share this information with affected employers. OSHA's
Consultation program provides free on-site assistance, and conducts numerous
training and outreach programs for small employers.
Enforcement
In recent years, along with our outreach and education efforts to reduce
needlesticks and other sharps injuries, OSHA has begun to
emphasize the enforcement of occupational health and safety standards for health
care workers, and in particular, enforcement of the bloodborne pathogens
standard.
OSHA identifies high hazard work sites for inspections through
our annual Data Initiative, a survey that collects lost workday injury and
illness (LWDII) rate data from 80,000 establishments. When the Data Initiative
first began, hospitals were not part of the surveyed population; therefore, no
comprehensive inspections were scheduled in this sector. A small number of
hospitals are being inspected this year under a pilot program involving data
from the 1998 survey. This year's Data Initiative Survey, using 1999 data,
includes 1,169 hospitals and we expect this to result in a higher number of
comprehensive inspections.
Conclusion
We believe that
implementation of the new compliance directive will provide our compliance
officers with the information they need to effectively enforce the bloodborne
pathogens standard,and raise employer awareness of, and compliance with, the
standard. I am confident that employers will find the new information in the
revised compliance directive to be helpful. With more than 600,000
needlesticks or other sharps injuries each year, OSHA,
employers, and employees must be proactive. It is in the country's best interest
to care for the people who care for us. Ensuring that health care workers are
protected from contracting deadly or debilitating diseases is the goal of our
revised compliance directive.
END
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