OSHA concedes, for now, calls off inspectors on TB fit-testing

Pressure builds on CDC to take clear stand on issue

Conceding hard-fought ground, the Occupational Safety and Health Administration (OSHA) has ordered its inspectors to stand down on the controversial issue of annual respirator fit-testing for health care workers occupationally exposed to tuberculosis.

A seemingly endless battle with infection control professionals over the TB issue took another turn Dec. 22, 2004, when OSHA issued a memorandum stating that "during fiscal year 2005, employers may not be inspected or cited for the requirement to do annual fit-testing of respirators for occupational exposure to tuberculosis."

The memo from R. Davis Layne, OSHA deputy assistant secretary, to agency regional administrators, clarified that "this prohibition applies to all OSHA compliance inspections, including programmed inspections, employee complaints, and imminent danger situations. If inspection activity regarding the annual fit-testing of respirators for tuberculosis has already taken place, the area director shall ensure that no citations are issued and no penalties proposed. If already issued, but not yet contested, any citation or proposed penalty shall be withdrawn," the memo noted.

OSHA had little choice after the Association for Professionals in Infection Control and Epidemiology (APIC) successfully lobbied Congress to cut the purse strings and leave the agency with no funds to enforce its New Year’s Eve 2003 edict to fit-test annually. At the time, shocked ICPs wondered if OSHA was taking it personally that APIC had been instrumental in defeating a similar requirement in the proposed OSHA TB standard.

With TB in sharp decline nationally, ICPs led a successful effort to kill the 1997 proposed TB standard. Undaunted, OSHA folded the fit-testing requirement into its 1998 general respiratory provisions, which had not been applied previously to health care. The concept is that unless the respirator fits properly, the employee will not be protected, but many ICPs argue that an annual requirement is overkill.

The recent OSHA concession on the issue vindicates ICPs who saw annual fit-testing as labor-intensive and unnecessary, but there’s considerable confusion across the health care landscape. Some hospitals already have set up annual fit-testing programs, and the funding restriction is only for the current fiscal year, which runs through October 2005. Still, some ICPs are not budging on an issue that almost has become a matter of principle.

"We are not going to be fit-testing this year," says Susan Kraska, RN, CIC, an ICP at Memorial Hospital of South Bend, IN. "Not only am I committed, but I believe Indiana APIC and national APIC are committed to doing the right thing. I don’t believe that fit-testing annually is the right thing."

It’s anybody’s guess whether OSHA finally will concede defeat on its decade-long effort to regulate TB infection control in health care settings. "I hesitate to say this will be the end of it," she says.

Indeed, the OSHA memorandum emphasizes that all other requirements of the respiratory protection standard, including annual fit-testing, may continue to be cited for respirator use against other hazards such as severe acute respiratory syndrome (SARS).

In addition, OSHA may cite other provisions of the respiratory rule that may relate to TB, including requiring an initial fit-test and retesting if an employee has facial changes. "Examples of conditions which would require additional fit-testing of an employee include (but are not limited to) the use of a different size or make of respirator, weight loss, cosmetic surgery, facial scarring, and the installation of dentures or absence of dentures that are normally worn by the individual," the OSHA memo stated.

That is a perfectly reasonable requirement and one many ICPs already are following, Kraska points out. "Let’s say you do original fit-testing and your employee gets pregnant. After the pregnancy, that would certainly warrant fit-testing. It certainly needs reviewing if changes occur."

The issue has been under contentious discussion since the early 1990s when nosocomial outbreaks heralded a strong resurgence of TB. Long lost in the debate, however, is that none of the ICPs in the hospitals involved actually used respirators in stopping the outbreaks. They focused instead on identifying and isolating unsuspected TB cases, she notes.

"I remember one of the ICPs holding up a surgical mask [at an APIC meeting] and saying with screening, isolation, and this, I stopped the outbreak in my facility," Kraska says. "There has been way too much focus on the respirators and fit-testing. In the end, the most important thing that we can do is keep our eyes on TB and other respiratory conditions. That should be our main focus. There has been a lot of time, money, and energy spent on the fit-testing issue."

In that regard, many observers question why the Centers for Disease Control and Prevention (CDC) didn’t step into the fray in its new draft TB guidelines and clarify that annual respirator fit-testing is not necessary. Instead, the CDC essentially tried to finesse the issue by recommending initial fit-testing and then retesting "periodically" thereafter.

"I see them kind of dancing around this subject," Kraska says. "I wish they would get in the trenches and see what’s happening with screening, isolating, and the practical side of it. ICPs are not interested in getting our employees in a risky situation. If the CDC simply asked us, What do you think needs to happen?’ I think there would be a resounding [consensus] that fit-testing does not need to be done annually. It should be done initially and then after if there are physical or other changes that would warrant it."

The CDC clearly is reticent to get into a clash with OSHA on the issue, though the decision to call for the nebulous "periodic" fit-testing was not done without considerable discussion.

A CDC epidemiologist involved in the process commented on the situation recently in Boston in explaining the draft guidelines at the 2004 annual meeting of the Infectious Disease Society of America (IDSA).

"What were the some of the challenges to achieving consensus? One is the fit-testing of respirators [and] the frequency of which the fit-testing should be performed," said Adelisa Panlilio, MD, MPH, medical epidemiologist in the CDC division of health care quality promotion (DHQP).

"We have continued to recommend initial fit-testing. One thing that is new is we talk about periodic fit-testing. However, the frequency or the periodicity of that fit-test is unspecified. We haven’t specified annual fit-testing."

Reminded by an audience member of the possible significant costs of annual fit-testing, Panlilio was asked why there was any need for the practice unless workers had undergone physical facial changes.

"Well, that is a very reasonable question, and we are struggling with that," she said. "However, there is another agency that actually has regulatory authority, OSHA. And OSHA has specified annual fit-testing in health care personnel. We are trying to resolve that. That is a big dilemma to us. That’s why in our guidelines we specified periodic fit-testing. We are well aware of that [financial concern] and are struggling to address that very issue."

In the interim, some hospitals are taking a guarded approach to an uncertain situation.

Response was mixed to the "Wicker amendment," the provision added by Rep. Roger Wicker (R-MS) to the federal spending bill, which prohibited OSHA from spending federal money to enforce the annual fit-testing rule.

Some states and individual facilities already had done the fit-testing or were in the process of doing so. For example, in California, hospitals were required to complete their updated fit-testing of staff by Jan. 18, 2005.

"Institutions that have begun a process to thoroughly implement [annual fit-testing] are likely not to make much change," says Judene Bartley, MS, MPH, CIC, vice president of Epidemiology Consulting Services in Beverly Hills, MI. "Other places that have been trying to determine the best way to approach this or are in the process of looking at who should really be fit-tested or not — I suspect some of them may say, This buys us some time.’"

Baystate Health System in Springfield, MA, mounted a major effort last year and fit-tested 2,800 employees. The three-hospital system hired an outside contractor and also used a train-the-trainer approach to update the fit-testing. The future of that program is uncertain, but James Garb, MD, director of occupational health and safety, notes the fit-testing rule still is in place.

"The occupational medicine and infectious disease community is still very divided on this," he explains. "There are some people who think you should do it, and others who think it’s not necessary."

The fit-testing had some benefits, Garb notes. The hospital now has a record of the dates employees were fit-tested, and the brand and size of the mask; and there was an educational component.

"We did find that a lot of [employees] in areas that didn’t use them that much didn’t even know which ones they were fit-tested for," he says.

Meanwhile, Garb and his colleagues are hoping for clarification on the fit-testing issue — and more generally on how to protect workers from the hazards of airborne infectious diseases. What diseases are truly airborne? How do you determine the level of hazard? What is the role of respirators?

"We all need a sense that there’s a single position by CDC on how they approach respiratory protection for agents that are known and how they approach the unknown," Bartley adds.

In that regard, Panlilio told those at the meeting that the CDC has formed a working group to develop such guidance, but has no clear time line for doing so. The group includes representatives from the DHQP, the National Institute of Occupational Safety and Health and the CDC division of TB elimination (DTBE).

"We at DTBE and DHQP have been trying to push for overarching guidance on respiratory protection that gives the various principles that are necessary and then have specific guidelines on preventing transmission of these diseases refer to the respiratory protection needs," she added. "But I don’t know how long it will take before we can actually produce such a guidance document."