Reversal of fortune: OSHA can enforce annual fit-testing provision for HCWs

APIC: 'There is really no science to support this decision.'

Amid the swirl of airborne threats such as pandemic flu and extensively drug-resistant tuberculosis (XDR-TB), the prevailing political winds finally have shifted as well. As a result, health care facilities must now adopt a contentious program that many infection control professionals say is expensive, labor-intensive and unnecessary: annual respirator fit-testing for heath care workers who treat TB patients.

As of Sept. 30, 2007, the Occupational Safety and Health Administration (OSHA) can begin enforcing the provision, which had been successfully blocked for years by the Association for Professionals in Infection Control and Epidemiology (APIC) and its political allies. But the so-called "Wicker amendment" that blunted enforcement of the measure ended recently when Rep. Roger Wicker (R-MS) conceded defeat in the face of health care union opposition and protests by nursing associations, occupational health clinicians and academics. APIC is advising membership of the reversal of fortune.

"There is really no science to support this decision," says Shannon Oriola, RN, CIC, COHN, a member of the APIC board and infection control director at Sharp Metropolitan Medical Campus in San Diego. "I don't know if 'frustrating' is the word, but we need to work with the political climate that we are in, and we need to move forward. We need to work with the manufacturers of the masks to [design] them so that [fit-testing] is not required. We are letting our members know that it failed and that there will be enforcement of this rule going forward."

For infection control 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," Oriola explains. "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]. 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. It depends on the size of the facility, really."

So why not just err on the side of caution and annually fit-test health care workers who treat TB patients? APIC had successfully argued annual fit-testing should be an option but not a mandated practice because it is not evidence-based, is extremely resource-dependent, and has not demonstrated to provide any additional benefit or protection to workers. Of course workers should be fit-tested on hire and thereafter if they have significant weight loss, surgery or other changes to facial features. Not only is the efficacy of routine, annual fit-testing unsubstantiated, it doesn't address the most significant risk to health care workers: the undiagnosed case, Oriola notes.

"The argument hasn't changed. It is just more of a political issue at the moment," she says. "TB has declined using the CDC guidelines. Really, [the risk] is the unknown patient that comes in for another reason and is missed. Certainly fit-testing won't stop the transmission of TB from a patient that comes in with an atypical presentation because you won't have that patient isolated."

In addition, 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," she says. That said, Oriola stressed that opposition to the provision in no way suggests a lack of concern for health care workers by APIC and the infection control community. "APIC shares a common goal of health care worker protection as well as patient safety," she says. "We would never compromise that mission. Annual fit-testing is not substantiated in science, but we do wholeheartedly embrace health care worker safety and would never compromise that. We are charged with not only protecting patients, but visitors and employees."

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.

"It's just common sense," says Mark Nicas, PhD, professor of environmental health sciences at University of California at Berkeley, tells Hospital Infection Control. "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 facepiece 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 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 don't buy the argument that the vast majority of infections are from the undiagnosed case," he tells HIC. "I am not saying that it is not important to correctly diagnose people, but I don't buy that argument without proof. 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."

Contacted by HIC and asked whether and how they would begin enforcement of the provision, OSHA declined to comment. "It is inappropriate for us to comment on pending legislation," said national OSHA spokeswoman Elaine Frazier. For its part, the Centers for Disease Control and Prevention continues to hold its position that respirators used in health care should be fit-tested initially and "periodically" thereafter.

[This] changes nothing as far as CDC recommendations," says Paul A. Jensen, PhD, engineering director in the CDC Division of TB Elimination. "We are detached from OSHA and we are not a regulatory agency. Our recommendation to OSHA and the rest of the world is [to fit-test] initially and periodically. We specifically did not say annual fit-testing. . . . Our feeling is that the data do not support a definitive periodicity of fit-testing."

Training key to avoid another SARS

By the same token, the CDC emphasizes the importance of training up workers participating in respiratory protection programs. "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," he says. 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 insure that people were initially assigned the proper respirator."

Such cautionary tales were sufficiently motivating for some ICPs and 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, she says, 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. "If you need proof, just look at how health care workers got SARS. Some of it had to do with not remembering how to put on and take off their personal protective equipment correctly, so they were contaminating themselves. So the more you can get in front of staff and remind them how to do things correctly, the better off we all are."