|
|
 |
  |
|
 |
| Q: What are the key provisions
of the Federal Needlestick Safety and Prevention Act?
|
| A: The Federal Needlestick Safety
and Prevention Act: |
| · Sets forth in greater detail
requirements for employers to identify, evaluate, and
implement safety-engineered medical devices. |
| · Requires the maintenance of
a sharps injury log |
| · Mandates involvement of non-managerial
employees in evaluating safety devices. |
| |
| Q: Is the law in full effect? |
| A: In 2002, all medical practices
and facilities should be using safety devices whose safety
feature is integral to the device. |
| |
| Q: How will OSHA enforce the
Needlestick Safety and Protection Act? |
| A: As of April 1,
2002, the Joint Commission on the Accreditation of Healthcare
Organizations (JCAHO) will require full compliance with
the new Bloodborne Pathogen Standard, including the use
of safety devices, in order to receive accreditation. |
| |
| Q: Who must use safety devices? |
| A: The Act applies to all employers
who have employees with reasonably anticipated occupational
exposure to blood or other potentially infectious materials
(OPIM), including: |
| · Hospitals |
| · Surgery Centers |
| · Medical Clinics |
| · Physician offices |
| · Nursing homes |
| · Home Care/ Home Infusion |
| |
| Q: Have citations been issued,
and which types of facilities have been fined? |
| A: Since the law was passed, OSHA
officials have inspected all types of healthcare facilities,
and have issued citations and fines to those not in compliance.
This has included hospitals, physician practices, surgery
centers and nursing homes. |
| |
| Q: What fines will OSHA issue
if a healthcare facility is cited for noncompliance? |
| Each citation can lead to a fine
of up to $7,000. "Willful" violations can lead to fines
as high as $70,000. Failure to use a safety product, such
as blunt tipped suture needles where applicable, can lead
to multiple citations, which could include: |
| Failure to document evaluation
and use of the safety product in the Exposure Control
Plan. |
| Failure to include involvement
of exposed employees in the evaluation and selection of
safety products. |
| Failure to implement safety products. |
| |
| Q: What if no one on our staff
has had a sharps injury? |
| A: OSHA intends to prevent occupational
injuries, exposures and illnesses. |
| |
| Q: What if a safety-engineered
option is not available for a medical device? |
| A: Employers also must investigate
availability of safety devices each year, and document
that fact in their Exposure Control Plan. If a safer device
is available, but back ordered or delayed, this must be
documented. The device must be implemented as soon as
it becomes available, and documented. |
| |
| Q: We have tried safety-engineered
devices, and we don't believe they are safer than what
we use today. Do we still need to convert to safety products? |
| A: This judgment will likely be
challenged since OSHA has already collected data from
across the country demonstrating that safety-engineered
devices do effectively reduce needlesticks. Deciding not
to use safety devices needs to be based on clinical justifications
that are clearly documented in the Exposure Control Plan.
In the absence of such clinical evidence, employers are
expected to adopt available safety devices. |
| |
| Q: What if safety-engineered
devices are "too costly"? |
| A: Before passing the Needlestick
Act, OSHA conducted an industry-wide cost/benefit analysis
and concluded that the use of safety medical devices was
beneficial due to the reduction in expenses associated
with testing and treating injured healthcare workers.
For example, workup and prophylaxis of a high-risk exposure
to HIV can cost as much as $3500. Moreover, $500,000 to
$1,000,000 may be spent to treat a worker who contracts
hepatitis C or HIV. |
| |
| Q: May we use the safety product
for only 'high-risk" situations? |
| A: No. The Law requires employees
to use safety devices in all cases where safer medical
devices are available. |
| |
| Q: Does OSHA publish a list
of available safer medical devices? |
| A: No. OSHA does not approve or
endorse any product. It is your responsibility as an employer
to determine which engineering controls are appropriate
for specific hazards, based on what is appropriate to
the specific medical procedures being conducted, what
is feasible, and what is commercially available. For more
information on blunt sutures, see Advanced
Precautions for today's OR. |
| |
| Q: Does the safety legislation
still apply when the physician is both the employer and
employee? |
| A: The BBP standard applies to
all workplaces, regardless of size, as not only are the
practicing physicians at risk of needlesticks, but also
those employees working with them and downstream. |
| |
| Q: Who must keep a sharps injury
log? Does it have to be confidential? |
| A: If your practice has 10 or
more employees, you must maintain a sharps injury log
for recording injuries from contaminated sharps. The Sharps
Log must detail the injury, the type and brand of device
involved in the injury (if known), the department or work
area where the exposure occurred, and an explanation of
how the incident occurred. The log must protect the confidentiality
of the injured employee. |
| |
| Q: What information do I need
to include in my written Exposure Control Plan? How often
to I need to update it? |
| A: In addition to what is already
required by the 1991 standard, the revised standard requires
the documentation of annual consideration and implementation
of appropriate engineering controls, and solicitation
of non-managerial workers in evaluating devices. The plan
must be reviewed and updated every year. |
| |
| Q: How does the revision affect
states that have their own federally-approved occupational
safety and health programs? |
| A: States with state OSHA programs
were required to adopt the revised standard by Oct. 18,
2001. States may choose to implement their own, more stringent
standards independently of the Needlestick Act. |
| |
| Q: Where can I get further
information about what is expected of an employer? |
| A: Employers should read the OSHA
Bloodborne Pathogens Standard and the Enforcement Procedures
for the Occupational Exposure to Bloodborne Pathogens,
which can be obtained at http://www.osha.gov or by phone
at 1-800-321-OSHA. The National Institute for Occupational
Safety and Health (NIOSH) and the Centers for Disease
Control and Prevention (CDC) also have documents related
to the prevention of occupational exposure to blood and
OPIM. |
| |
| top
of page |
WHAT
OSHA REQUIRES IN THE OR
|
The New OSHA Compliance Directive:
|
| · Relevance for Surgical Work
sites |
| · Physician and Surgeon Responsibility |
| · Liability of Physicians and
Surgeons to Citation |
| |
| Abstract: The Compliance
Directive issued by OSHA (DIRECTIVES NUMBER: CPL 2-2.44D),
effective November 5, 1999, establishes policies and provides
clarification to ensure uniform inspection procedures
to enforce the Occupational Exposure to Bloodborne Pathogens
Standard. This is a Federal Program Change which applies
OSHA-wide; all states are expected to have standards,
enforcement policies and procedures which are at least
as effective. |
| |
| Background: On December
6, 1991, OSHA issued its final regulation on occupational
exposure to bloodborne pathogens, based on a review of
information which showed health care workers face a significant
health risk as a result of occupational exposure to blood
and other potentially infectious materials which may contain
bloodborne pathogens. (Current estimates vary between
590,000 and 800,000 injuries annually.) Bloodborne pathogens
include but are not limited to those which cause hepatitis
B, AIDS, hepatitis C, Creutzfield-Jacob disease, syphilis,
malaria, viral hemorrhagic fever, leptospirosis, brucellosis,
babesiosis, arborviral infections, relapsing fever, and
HTLV-1. The agency further concluded these hazards can
be minimized or eliminated by using a combination of engineering
and work practice controls, personal protective clothing
and equipment, training and medical surveillance, and
signs and labels. |
| |
| New Technology and Work Practices:
In the new Compliance Directive, OSHA clarifies its position
regarding the implementation of effective engineering
controls to reduce needlesticks and other sharps injuries.
Effective engineering controls include the use of safer
medical devices to prevent percutaneous injuries before,
during, or after use through safer design features. The
employer must use engineering and work practice controls
to eliminate or minimize occupational exposure. Examples
cited include no-hands passing of sharps, blunt suture
needles, needleless IV connectors, and self-sheathing
or retracting needles or syringes. Significant improvements
in technology are most evident in the growing market of
safer medical devices. There is now a large body of research
and data available to OSHA and the public concerning
the effectiveness of these engineering controls. Where
engineering controls will reduce employee exposure either
by removing, eliminating or isolating the hazard, they
must be used. |
| |
| Training and Education: OSHA
does not advocate the use of one particular safer device
over another, but expects employers and users to use CDC
studies of efficacy, pilot tests by the employer or data
available in published studies to choose from available
safer devices and implement them. Employers must train
and educate employees who use safer devices and work practices
to ensure acceptance and proper use. If a combination
of engineering and work practice controls used by the
employer does not eliminate or minimize exposure, the
employer shall be cited for failing to use engineering
and work practice controls. |
| |
| Personal Protective Equipment:
The type and amount of PPE must be chosen to protect against
contact with blood or other potentially infectious materials
based upon the type of exposure and quantity of these
substances reasonably anticipated to be encountered during
the performance of a task or procedure. |
| |
| Physicians' and Surgeons' Responsibility:
Compliance is required when physician or surgeon is the
employer of one or more employee(s) who may have contact
with blood or body fluid. Physician or surgeon must control
or prevent bloodborne pathogen hazards that expose their
employees and/or hospital employees at the hospital
in surgery or other invasive procedures. Physician/surgeon
practices must have an Exposure Control Plan, identify
employees at risk for exposure and provide bloodborne
pathogen education at time of employment and annually.
Identified employees must be offered hepatitis B vaccination
free of charge. Post exposure evaluation and follow up
must be provided if an exposure occurs, to include medical
evaluation and post exposure prophylaxis if indicated.
Required record keeping for education records is 3 years
and exposure records is 30 years. While in the hospital,
as in the office, physicians and surgeons must use safer
devices when they will remove, eliminate or isolate the
exposure hazard, use personal protective equipment and
safe work practices, and follow the hospital Exposure
Control Plan. |
| |
| Surgeons as Employees or Employers:
In the section of : CPL 2-2.44D defining Multi-Employer
and Related Worksites (pages 5-7), OSHA states that physicians
and healthcare professionals who have established an independent
practice may be employers or employees. Physicians who
are unincorporated sole proprietors or partners in a bona
fide partnership are employers for purposes of the OSH
act and may be cited if they if they employ at least one
employee (such as a technician or secretary). Such physician-employers
may be cited if they create or control bloodborne pathogens
hazards that expose employees at hospitals or other sites
where they have staff privileges. Physicians may be employed
by a hospital or other healthcare facility or may be members
of a professional corporation and conduct some of their
activities at host employer sites where they have staff
privileges. Where professional corporations are the employers
of their physician-members, professional corporations
may be cited for exposure of its physicians and other
workers at a host employer site. |
| |
Summary:
|
| In order to comply with OSHA
COMPLIANCE DIRECTIVES NUMBER CPL 2-2.44D, employers who
provide surgical and obstetrical services and physicians
who use those facilities will need to update their existing
exposure control plan, choose and implement effective
engineering and work practices from the broadening market
of safety devices, and eliminate or minimize occupational
exposures. |
| top
of page |
FREQUENTLY ASKED QUESTIONS:
|
| Q. Why the need for a new Compliance
Directive? |
| A. The Occupational Safety
and Health Administration (OSHA) issued a revised directive
intended to protect healthcare workers from bloodborne
pathogens. The directive stressed the importance of annual
reviews of employers' bloodborne pathogens programs and
the use of safer medical devices and work practices to
reduce needlesticks and other injuries from sharp products.
The new OSHA directive will help minimize serious health
risks faced by workers exposed to blood and other potentially
infectious materials (OPIM). Among the risks are human
immunodeficiency virus (HIV), hepatitis B and hepatitis
C. Hepatitis C virus (HCV) is the most common chronic
bloodborne infection in the United States. |
| |
| Q. What's new about it? |
| A. OSHA has always required
employers to use engineering and work practice controls.
The employer now must use engineering and work practice
controls that eliminate or minimize occupational exposure.
It updates an earlier directive issued in 1992 and reflects
the availability of improved devices, better treatment
following exposure and OSHA policy interpretation. |
| |
| Q. What is its function and
purpose? |
| A. The directive guides
OSHA's compliance officers in enforcing the standard that
covers occupational exposure to bloodborne pathogens and
ensures consistent inspection procedures are followed.
Effective November 5, 1999, employers, including hospitals
and physicians, may be cited for failure to comply with
the new directive. |
| |
| Q. What are the key points
of the new OSHA Compliance Directive? |
| A. The following is a summary
of some of the key revisions. |
| |
| · The directive emphasizes the
use of effective engineering controls, including safer
medical devices such as blunt suture needles, work practices
including no-hands passing of sharps in the operating
room, administrative controls and personal protective
equipment. |
| |
| · Employers must ensure that their
annually reviewed Exposure Control Plan reflects consideration
and use of commercially available safer medical devices.
The plan must document consideration and implementation
of appropriate commercially available and effective engineering
controls designed to eliminate or minimize exposure, subject
to citation. |
| |
| · Employers should rely on relevant
evidence in addition to FDA approval to ensure effectiveness
of devices designed to prevent exposure to bloodborne
pathogens. |
| |
| · Employee acceptance and employee
training are required for the engineering control to be
effective. |
| |
| Q. What if my state has its
own OSHA regulations? |
| A. The Compliance Directive
applies OSHA-wide. States are to have standards, enforcement
policies and procedures at least as complete as federal
OSHA. |
| |
| Q. How are safety devices selected? |
| A. Each healthcare setting
is urged to have its own tailored program that is developed
with input and review from workers. In addition, devices
should be used and evaluated as part of a comprehensive
program of safe work practices, in which workers are trained
in certain safety practices. |
| |
| Q. How effective have exposure
prevention programs been? |
| A. Some institutions have
achieved success in reducing injuries by as much as 88
per cent. |
| |
| Q. How common are sharps injuries? |
| A. The CDC estimated that
there are 600,000 to 800,000 occupational needlestick
injuries each year, which could lead to serious or potentially
fatal infections such as hepatitis C or HIV, particularly
in surgery. The precise number could be higher because
needlesticks often go unreported, especially in the OR. |
| |
| Q. What if safety controls
cannot be used? |
| A. Employers must take
advantage of new technological devices and replace risky
work practices to eliminate risk of exposure to blood
and other infectious materials in the workplace. In instances
where it is impossible to use safety controls, OSHA compliance
officers will expect employers to have documented why. |
| |
| Q. How much can OSHA fine,
and are multiple violations possible? |
| A. Employers who do not
update their exposure control plans annually and do not
use safety devices are in double violation of the standard.
Fines range from $7000 to $70,000, with the largest fines
assessed against employers who knew about a hazard, knew
employees were exposed and purposely chose not to do anything
about it (willful violations). Penalties are made on a
case-by-case basis. |
| |
| Q. Which types of employers,
other than hospitals, may be liable to citation? |
| A. The Multi-Employer Work
sites section of the new Compliance Directive focuses
on physicians in independent practice, employment agencies,
personnel services, home health services, and independent
contractors. Physicians on staff at hospitals who are
not hospital employees may not be cited for exposing themselves
to the hazards of bloodborne diseases, however, under
the multi-employer guidelines, such physicians or their
professional corporations (employers) may be cited if
they cause exposure of associates or employees at hospitals,
surgicenters or other sites where the surgeons have privileges. |
| |
| Q. Who is responsible for education? |
| A. The onus is on the employers
to educate personnel to use safety devices correctly and
to monitor to ensure compliance with safe use practices.
The use of effective training and education is required
for employees whenever safer devices are implemented.
Interactive training sessions are stressed rather than
just the use of films or videos that do not provide the
opportunity for discussion with a qualified trainer. |
| |
| Q. How many inspections does
OSHA conduct per year in response to possible violation
of the Bloodborne Pathogen Standard (BPS), and how many
citations are issued? |
| A. In fiscal year1999,
34,245 inspections were conducted in all categories; of
those, 806 were in the health care setting, and 539 were
for violations of the BPS (1910.1030). Total citations
for violations of the BPS was 1,026. |
| |
| Q. How many citations are challenged
annually by employers, and what percentage of challenges
are successful? |
| A. Of 806 inspections for
BPS violations, 69 were contested. As of April, 2000,
no data was available on the outcome of the contested
violations. |
| |
| Q. What is the cost of exposures? |
| A. Hospitals have reported
paying up to $3500 for follow-up, monitoring and testing
of an employee with a high risk exposure, and up to $1
million for employees who become infected with HIV on
the job. High-risk exposure could lead to hepatitis C,
with an 85% chance of developing chronic liver disease
with a 75% chance of requiring a liver transplant. (See
also Cost of Sharps Injuries). |
| top
of page |
| References and resources for
information access: |
| 1. To receive a hard copy of the
263 page Compliance Directive, call the OSHA Office of
Health Compliance Assistance (202) 693-2190. To download
the document, visit the OSHA web site at www.osha.gov. |
| The directive replaces and updates
appendices. It includes the following: examples of committees
in health care facilities; sample engineering control
evaluation forms; an Internet resource list; a "fill-in-the-blanks"
sample exposure control plan; and CDC guidelines pertaining
to HIV exposure, control and prevention of hepatitis C,
and hepatitis B vaccinations. |
| |
| 2. Advances in Exposure Prevention
Vol 5, No 1-2000:1-10. Visit the web site of the International
Health Care Worker Safety Research and Resource Center
at the University of Virginia: www.med.virginia.edu/~epinet.
|
| |
| 3. Visit the Premier
Safety Web site at www.premierinc.com/safety |
| |
| 4. Visit www.NAPPSI.org
for an extensive list of all classes of safety devices. |
| top
of page |
|
|
|
