OSHA can enforce annual fit-testing
As of Sept. 30, 2007, the Occupational Safety and Health Administration (OSHA) is enforcing the provision that requires health care facilities to adopt annual respirator fit-testing for employees who treat TB patients.
For programs that have not been doing annual fit-testing, the level of labor intensity required to meet the provision will depend on such factors as the number of airborne isolation rooms at the facility and how many employees are going to be designated to enter them when they house TB patients.
"Facilities should stratify who they fit-test according to how they have structured assignments for their nursing staff," says Shannon Oriola, RN, CIC, COHN, a member of the Association for Professionals in Infection Control and Epidemiology (APIC) board and infection control director at Sharp Metropolitan Medical Campus in San Diego.
"If you have a small hospital and one airborne isolation room, but the nurses float around, you might have to fit-test more people. If you dedicate personnel to a certain unit that has airborne infection isolation containment," you may have to fit-test less, Oriola says. "Then there is the cost of supporting a program if [you do it in-house] or whether you hire someone specifically to do the fit-testing," Oriola says. "It depends on the size of the facility, really."
Of course workers should be fit-tested on hire and thereafter if they have significant weight loss, surgery, or other changes to facial features.
TB is at record lows in the United States, which should generally translate to reduced occupational risk for health care workers. "Since most hospitals have adopted CDC TB guidelines, we don't see the occupational risk like we did in the 1980s and early 1990s," Oriola says.
Making the case for fit-testing
Proponents of annual fit-testing argue that vigorous respiratory protection programs are critical in the aftermath of severe acute respiratory syndrome (SARS), the ongoing threat of airborne bioterrorism, the emergence of XDR-TB, and the future threat of pandemic flu.
Occ health scientists lobby on fit-testing
In what may have had a critical influence on a recent decision to restore enforcement of annual fit-testing in health care settings, more than 50 occupational and environmental health researchers and professors signed a letter to David Obey, chairman of the Committee on Appropriations in the U.S. House of Representatives. The letter is summarized as follows:
Dear Mr. Chairman:
The signers of this letter, scientists and experts in the field of occupational safety and health, are writing to express our strong opposition to the Wicker amendment that would prohibit OSHA from enforcing the annual fit-testing requirement of its respirator standard as it applies to exposure to tuberculosis (TB). This amendment would place health care workers and first responders at increased risk of developing TB. Respirators can only offer adequate protection to the wearer if they fit well on the wearer's face. To determine if a respirator fits properly and does not leak, it is essential that an initial fit-test be performed. The scientific evidence establishing the need and requirement for fit-testing is substantial. The evidence clearly shows that fit-testing is essential in order to identify respirators that fit well on the worker's face and that passing a fit-test increases the likelihood of receiving the expected level of protection that is assigned to the respirator. Research has also shown that in the absence of fit-testing, many respirators fail to provide adequate protection.
In order to maintain continuing adequate protection of the respirator, it is essential that follow-up fit-testing be conducted. The scientific evidence also supports the OSHA regulatory requirement to conduct fit-testing on an annual basis. Performing annual fit-tests will ensure that workers maintain the level of protection the respirator is designed to provide.
Our government's scientific expert agency on respiratory protection, the National Institute for Occupational Safety and Health (NIOSH), strongly supports the necessity of conducting initial and annual fit-testing for workers who must wear respirators on the job. That would include health care workers and first responders exposed to TB. We believe that Congress should rely and act on the expertise and advice by NIOSH and support annual fit-testing for workers exposed to TB and oppose the Wicker amendment.
"It's just common sense," says Mark Nicas, PhD, professor of environmental health sciences at University of California at Berkeley. "If you are going to worry about these [airborne] infectious disease outbreaks and you want to contain them, you better have a health care work force that is prepared to deal with this. Quite honestly, just issuing N95 respirators — which don't fit all that well to begin with — and then arguing that annual fit-testing [is not necessary] is really a bad approach to being prepared."
Nicas joined other occupational health scientists in submitting letters and arguments requesting that the annual fit-test provision be restored. In his letter, Nicas warned that "the current situation is that the frontline personnel trying to contain an outbreak would be health care workers equipped with poorly-fitting N95 filtering face piece respirators [due to the lack of adequate fit-testing]. We can anticipate that numerous health care workers would be infected, and perhaps serve as unknown vectors of infection before becoming too clinically ill to continue working. We can also anticipate that their co-workers might not show up for work due to the realization that they were not being adequately protected."
In addition, Nicas and other proponents of annual fit-testing reject the position that the prime risk is the undiagnosed case. "I am not saying that it is not important to correctly diagnose people, but I don't buy that argument without proof," he says. "I know that when federal OSHA originally promulgated their [TB] standard, they submitted data on what happened when you fit-test people over time. I'm not claiming that there is going to be a lot of good data there, but they showed in the little data that was submitted that there was a decrease in successful fit-tests as time went by."
Fit-testing 101: Basics from NIOSH, OSHA
Conduct a risk assessment and determine who must wear a respirator and be included in the program. A fit-test must be conducted to determine which brand, model, and size of respirator fits the user adequately and to ensure that the user knows when the respirator fits properly. Such knowledge is important because TB aerosol can leak around the face piece into the respirator and be inhaled if the respirator does not fit the user's face.
Determining face piece fit involves qualitative fit-testing (QLFT) or quantitative fit-testing (QNFT). A QLFT test relies on the wearer's subjective response to taste, odor, or irritation. A QNFT uses another means of detecting face piece leakage and does not require the wearer's subjective response. Respirator models and brands have inherently different fitting characteristics. Therefore, more than one brand or model and various sizes of a given type of respirator should be purchased to take advantage of the different fitting characteristics of each and to increase the chances of properly fitting all workers.
Procedures for fit-testing:
OSHA requires employers to conduct fit-testing using the following procedures:
1. Employees choose the most acceptable respirator from a selection of various sizes and models.
2. Prior to selection, employees are shown how to put on a respirator and determine an acceptable fit. This is a review, not formal training.
3. Employees are informed that they are being asked to select the respirator that provides the most acceptable fit for protection.
4. Employees must hold each face piece up to the face and eliminate those that do not provide an acceptable fit.
5. The most acceptable mask is worn at least five minutes to assess acceptability.
6. Assessment of acceptability includes reviewing the following points with each employee:
7. Adequacy of fit includes the following criteria:
8. Employees conduct negative- and positive-pressure fit checks, after being told to seat the mask on the face by moving the head from side to side and up and down slowly while taking slow, deep breaths.
9. The test shall not be conducted if there is stubble beard growth, beard, mustache, or sideburns that cross the respirator sealing surface.
10. Employees who have difficulty breathing during tests shall be referred to health care professionals for assessment of their ability to wear a respirator.
11. Employees who find the respirator fit unacceptable are allowed to select a different respirator and be retested.
12. Before the fit-test, employees are given a description of the test procedure and their responsibilities during it.
13. Employees shall perform exercises during the test while wearing applicable safety equipment that may be worn during respirator use that could interfere with fit, in the following order:
Each test exercise should be performed for one minute, except for the grimace, which is performed for 15 seconds. The employee should be asked about the acceptability of the respirator upon completion of the protocol. If unacceptable, the process should be repeated with another respirator before proceeding to the specific qualitative or quantitative test protocols.
Sources: National Institute for Occupational Safety and Health (NIOSH) and Occupational Safety and Health Administration (OSHA).
Training key to avoid another SARS
The Centers for Disease Control and Prevention (CDC) emphasizes the importance of training workers participating in respiratory protection programs. Paul A. Jensen, PhD, engineering director in the CDC Division of TB Elimination, says, "Some people jump to the fit-testing issue, but if we train people properly, then fit-testing can be used as a part of the training program."
Such training should include the types of respirators used in the hospital and, for example, whether a basic N95 mask is appropriate for TB patient care or if a powered air-purifying respirator should be worn when doing a procedure on a TB patient that may generate aerosols, he explains. Though health care workers certainly were exposed to undiagnosed cases of SARS during the 2003 outbreak in Toronto, a contributing factor to the occupational infections may have been their lack of training and familiarity with respirators.
"That's one of the theories in Toronto," Jensen says. "They had the equivalent of N95s but they didn't really have the training and they did not ensure that people were initially assigned the proper respirator."
Such cautionary tales were sufficiently motivating for some occupational health professionals to adopt annual fit-testing even when the OSHA enforcement exemption was in place. "We went ahead and did it, so now this will have no impact on us," says Susan Johnson, assistant director and medical center safety officer at Vanderbilt University Medical Center in Nashville, TN. "From our perspective it's not just TB, it's any kind of airborne-type disease."
Indeed, Tennessee OSHA state plan officials advised them that the annual fit-testing exclusion would not apply if respirators were being used to protect health care workers against airborne pathogens other than TB, Johnson says. "So we just said, 'We are just going to come to the table and do what we need to do.'"
Going to an annual fit-testing program will be labor-intensive for those hospitals that have not been doing so, says Johnson, emphasizing that limiting the number of employees designated for testing is a common approach to controlling costs.
"We have over 800 beds, and unfortunately we don't cohort TB patients," Johnson says. "Some hospitals get to cohort and so therefore they can limit the staff that are fit-tested. We have not done that, so we fit-test about 4,000 people a year. We had to hire a tech just to do that. It will have an impact. It's one more thing that you have to do."
Johnson's program uses the qualitative test, which indicates fit-test failure if the worker can taste exposure to a sweet or bitter agent. "We've been doing this for three years. It is a big program, but we just kind of chipped away it," she reports. "When we first implemented it, we had a committee that included safety, infection control nurses, and occupational health. I won't say it has been a seamless process, but we have tried to make it that way."
The program ensures that hospital staff are familiar with their respirators, and are well trained in donning and removing them should another airborne infection such as SARS emerge. "We have seen that the training is worth it; to get everyone on staff on an annual basis is worth it," Johnson says.