OSHA warns: Don't delay respirator fit-testing
OSHA warns: Don't delay respirator fit-testing
Waiting for final TB standard could bring trouble
Hospitals that are waiting for the U.S. Occupational Safety and Health Administration (OSHA) in Washington, DC, to issue its long-awaited tuberculosis standard before fit-testing employees for the new N95 respirators are violating federal regulations and could be in for a citation under OSHA's current respirator standard, agency officials warn.
Concerns over TB masks focused last year on the issue of replacing the costly and unpopular high-efficiency particulate air (HEPA) respirators OSHA formerly required for health care worker protection. HEPA masks had been the only respirators that met protective standards established in TB guidelines by the federal Centers for Disease Control and Prevention (CDC) in Atlanta.1
Many hospital officials questioned the efficacy of HEPA masks -- which were designed for industrial use -- against biologic agents in health care settings. Respiratory protection in hospitals ranged from basic surgical masks to a variety of particulate respirators, depending mainly upon a facility's TB patient population, use of engineering controls, and budgetary limitations.
In mid-1995, the National Institute for Occupational Safety and Health (NIOSH) in Washington, DC, established a new respirator classification and certification system that signaled an end to the HEPA requirement.2 NIOSH now certifies nine types of air-purifying particulate respirators in three categories -- N, R, and P -- with filter efficiency levels of 95%, 99%, and 99.97% against penetrating aerosol particles of 0.3 micron.
As the least expensive and most comfortable option that still meets minimum CDC standards, the "N95" respirator has become the device of choice for most hospitals. A number of manufacturers produce N95 models, and many disposables cost less than $1 per respirator. (See Editor's note at end of this article.)
Nevertheless, the move to cheaper masks has not laid the respirator issue to rest. Hospitals now are focusing concern on OSHA's requirements for fit-testing the new respirators.
The agency's separate respiratory protection standard calls for comprehensive fit-testing and fit-checking programs (29 CFR 1910.134). While OSHA is updating the respiratory protection standard for industry and drafting a proposed TB standard for health care facilities, procedures and requirements for fit-testing the new classes of particulate respirators have not changed from those the federal agency currently requires, according to a recent OSHA memorandum obtained by Hospital Employee Health.
The four-page memorandum clarifies an OSHA compliance directive issued earlier this year (OSHA Instruction CPL 2.106), which had reflected the CDC's 1994 revised TB guidelines and the new NIOSH respirator certification system. (See related story in HEH, April 1996, pp. 42-43.)
Rich Fairfax, CIH, an industrial hygienist in OSHA's health compliance office, says the memorandum was issued due to "a lot of confusion and questions" from the health care industry.
"The compliance directive mentioned doing fit testing and fit checking in accordance with OSHA standards, and we didn't think there would be any problem with it, but with the new N95 respirators coming out, everyone seemed to be having all sorts of troubles," Fairfax says.
Some jobs require baseline fit tests
While the memo mainly addresses some of the most commonly asked technical compliance questions about fit testing (see related story, p. 64), the concerns of many employee health practitioners and other hospital officials relate to whether fit-testing the new respirators is necessary, and if so, for whom and how often.
"If someone is assigned a job where they have to wear a respirator, then they have to be fit-tested. That fit test is a baseline. Then we would expect another fit test if they change respirators or if [the HCW] had gained or lost a lot of weight or undergone something that might change the facial features. Hospitals have had employees on respirators for [exposure to] a lot of other things like formaldehyde and ethylene oxide, so it's not like they have to do anything new," he adds.
Fairfax points out that HCWs must use respirators in three situations: when entering an isolation room housing a TB patient, when performing a procedure that is high-risk for TB exposure, and when transporting a TB patient.
In speaking with EHPs across the country, HEH has found a range of responses to the fit-testing issue. While some EHPs have completed all or part of their fit-testing program for the new N95 respirators, others say a low risk of TB exposure at their hospital makes fit-testing unnecessary. Still others have decided to wait until OSHA issues a TB standard, which may or may not call for annual fit-testing, they say.
One EHP at a large Southern university hospital says she and many of her colleagues are "waiting until we absolutely have to do it."
Fit-testing is expensive and unnecessary in most cases, says the EHP, whose identity is being kept confidential to avoid triggering an OSHA inspection. For hospitals such as hers that fall into the CDC's minimal or very-low-risk assessment categories, a comprehensive fit-testing program is "ludicrous," she says.
"In high-risk areas, such as sputum induction, those people should be fit-tested, and that's doable and cost-effective. But to fit-test everybody in a respiratory care department or everybody who does direct patient care because they may come into contact with someone who has TB is simply not cost-effective. I envision that as painful," she states. "For facilities where there is little hazard, it's like much ado about nothing."
Fit testing regardless
Nevertheless, her hospital probably will move ahead with a fit-testing program within the next few months because "it's clear that interim [OSHA] guidelines already are being issued to compliance officers, and that's probably going to move a lot of people forward, including us," she says, adding that her hospital had "only three or four TB isolates" in the past year.
Another EHP at a small Midwestern hospital says administrators there decided fit-testing many of their 500 employees would be too costly and possibly unnecessary. Only one patient with confirmed TB was identified in the past year.
"We would have to fit-test everybody because when you're a smaller hospital, you tend to use everybody in the house to do many things. We've chosen to wait until the final [TB] standard comes out with what OSHA will require. We're not doing [fit-testing] until this gets clarified," she says.
But OSHA officials say hospitals that adopt such wait-and-see stances or that fail to fit-test due to a perceived "low risk" could be asking for trouble.
Having just one TB patient within six months triggers a need for a respirator fit-testing program, Fairfax says.
"Our standards require that if there is [TB] exposure, regardless of risk, they have to [fit-test]. If we came into a facility that had not done any fit testing, and they didn't have any exposures to TB within the last six months, we could not issue a citation. But if we went in and found they didn't fit-test anybody, and then we found out that five and a half months ago they had a patient with confirmed TB, we could issue a citation for not doing fit-testing, even though they had only one patient," he states.
The agency also presently recommends at least an annual respirator fit-test, says Fairfax, although frequency is not specified in the current respirator standard.
While some hospital officials hope that comprehensive fit-testing programs will not be part of the TB standard currently being drafted, it seems likely that a fit-testing requirement will be included.
During stakeholder meetings held on a preliminary draft proposal last fall, OSHA was considering a fit-testing requirement, says Kevin Landkrohn, MS, an industrial hygienist in OSHA's health standards program and leader of the team that is drafting the proposed standard. The proposal is slated for publication in the Federal Register this September.
"There were concerns all around," he says. "Some people felt it was necessary, some felt it was not necessary, some felt it should be on an annual basis, some felt it should not. There has been no review or approval [of the draft] yet."
Compliance required now
Instead of waiting for a final standard, hospitals need to be concerned about present enforcement activity, Landkrohn emphasizes.
"When the TB standard comes out, it will only be a proposal that is up for further comment. All comments will be assimilated before a final standard comes out, so you're looking at quite a stretch into the future before you have a final regulation. [Hospitals] need to be thinking of what is required by the compliance directive now," he says.
Caroline Freeman, a director of the OSHA health standards program, confirms only that fit testing is "under consideration" in the TB standard. Cost estimates for hospitals will be included if fit-testing programs are required.
"Fit-testing of health care workers is a big-ticket issue," says Freeman. "If we require fit testing with a frequency that's specified for these new N95 respirators, we have to justify it. We have to show the cost of it and why we think it's feasible. We're aware that this is a very serious issue for the health care community, and our goal is to get everybody covered as best and as cheaply as we can."
A final TB standard is at least a couple of years away, she notes, "based on the process we have to go through."
In the meantime, some EHPs have gone full speed ahead with their N95 respirator fit-testing programs.
Mary Ellen Peebles, RN, COHN-S, employee health manager at 2,500-employee Piedmont Hospital in Atlanta, says officials were "distraught" at first over the need to purchase new masks and conduct fit-tests because the laser masks employees previously used were successful in preventing conversions.
New employees present stumbling block
Nevertheless, the fit-testing program for about 1,800 workers began about eight months ago with a train-the-trainer program.
"It didn't take long to train the trainers or go through the hospital [fit-testing other current employees], but the stumbling block is getting the new employees fit-tested," Peebles says. "We are trying to incorporate that in our orientation day so we can be certain there won't be any delay, but our orientation day is crammed full already. It's difficult to find a 30-minute period to test some of the new employees because they don't all need it done. That's been very problematic for us."
An educational program was developed by the employee health, infection control, respiratory care, and education departments. The respirator manufacturer assisted in the fit-testing program, especially with employees who were difficult to fit-test due to face shape or size.
Gretchen R. Banks, MA, RRT, administrative director of respiratory care services at Piedmont Hospital, produced a 10-minute video that is used to teach employees about TB, respirator use, and fit testing.
Banks warns of several pitfalls to watch for in fit-testing programs. One is the difficulty of fit-testing certain employees due to facial contours.
"We're a low-risk [for TB exposure] institution, so we didn't feel the need to supply them with anything different such as a full-face air-powered respirator, but we would do that if we were in a high-risk situation," she says.
There is another potential problem for hospitals that use saccharin-aerosol challenge agents in qualitative fit-tests. (See related story, p. 64.) Employees should be instructed not to eat or drink anything containing saccharin for at least 30 minutes before the test, Banks says, because this could prevent them from detecting the test's saccharin aerosol.
"There were a small number of folks who were not sensitive to saccharin and couldn't taste it," she adds. "We did not revert to doing a smoke test because we are in the low-risk category."
New N95 respirators have just arrived at Riverside (CA) General Hospital, and fit-testing has begun, says Sally Peerbolt, RN, employee health nurse. Riverside, a high-risk county hospital with about 1,600 employees, began with a train-the-trainer program. Trainers are employees in departments that use TB respirators the most, such as respiratory therapy, quality assessment, health education, and environmental services.
Peerbolt is setting up two-hour sessions of 15 employees each for fit-testing about 800 workers on all shifts. The respirator manufacturer has supplied videotapes about fit tests and how to wear the masks. After their fit test, employees get a small card verifying that they have been fit-tested, the name of the mask, and its size, "so when they need it to be replaced, they will have that with them," Peerbolt says.
"I know the doctors will be the most difficult [to bring in for fit-testing]," she adds, "so they will have to show me they have been fit-tested with this particular brand [of respirator], or else they will not be getting these masks."
Another challenge lies in the fact that a new rotation of residents from a nearby university medical school enters the hospital every few months, so they will have to be fit-tested as well.
Peerbolt says education is the key to successful use of the new respirators. Previously, employees wore surgical-type masks and discarded them after a single use. Now, employees must be educated and trained to retain their masks for a number of wearings before discarding them.
According to NIOSH, reuse of particulate respirators is permitted for tuberculosis protection provided the masks have not been damaged or soiled, or that the breathing resistance has not become great enough to cause the wearer discomfort.
[Editor's note: For a list of the most recent NIOSH-certified particulate respirators, call (800) 35-NIOSH. For a copy of the OSHA memorandum on respirator fit-testing and fit-checking procedures, call your OSHA regional office: Region I, Boston, (617) 565-7164; Region II, New York, (212) 337-2326; Region III, Philadelphia, (215) 596-1201; Region IV, Atlanta, (404) 347-3573; Region V, Chicago, (312) 353-2220; Region VI, Dallas, (214) 767-4731; Region VII, Kansas City, (816) 426-5861; Region VIII, Denver, (303) 391-5858; Region IX, San Francisco, (415) 975-4310; Region X, Seattle, (206) 553-5930.]
References
1. Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care facilities, 1994. MMWR 1994; 43(No. RR-13):1-132.
2. U.S. Public Health Service. National Institute for Occupational Safety and Health. Respiratory protective devices; certification requirements. 60 Fed Reg (June 8, 1995):30,336-30,398. *
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