Stalled TB rule leaves fit-testing confusion
Hospitals perplexed about respirator compliance
With a pending tuberculosis standard still stalled, hospitals face confusion as they try to comply with existing requirements for their respiratory protection programs. Annual fit testing, a controversial aspect of the tuberculosis standard proposed by the Occupational Safety and Health Administration (OSHA), is currently required for all respirator use except in TB prevention. Current OSHA regulations do, however, require hospitals to provide at least initial fit testing for employees who may provide direct care to tuberculosis patients.
"We are now under seven different guidelines [including a respiratory protection standard and compliance directives] in order to figure out what we’re supposed to do in hospitals," says Larry Lindesmith, MD, FACOEM, FCCP, medical director of employee health and safety at Gundersen Lutheran Medical Center in La Crosse, WI. "Depending on how you read as many as seven different guidelines, it’s no surprise we end up with different approaches in different places."
This confusion is a major justification for a new TB standard, he says. "They were making good progress towards it being a reasonable standard in their final drafting," says Lindesmith, who saw a draft version. However, under the Bush administration, Lindesmith and others expect the TB standard to be stalled, at best.
IOM: TB standard based on flawed estimates
The TB standard’s future has been further clouded by an Institute of Medicine (IOM) report as well as a Centers for Disease Control and Prevention announcement that TB guidelines are being revised once more. The IOM panel said the proposed OSHA standard didn’t allow enough flexibility and was based on flawed estimates of the TB risk.1 Qualitative fit-testing involves releasing saccharin or Bitrex (a bitter substance) into the air and asking the respirator-wearer whether he or she detects it.
According to Gregory Wagner, MD, director of the division of respiratory disease studies at the National Institute for Occupational Safety and Health (NIOSH), that is a minimal test necessary
to make sure the respirator conforms to CDC guidelines. "Anybody who is required to wear a respirator should be fit-tested on a regular basis," he says. "If someone’s wearing a respirator, they ought to have some reasonable assurance it’s going to be effective." (For a copy of a fit-testing personnel form recommended by NIOSH, see p. 98.)
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To make this procedure more feasible, Lindesmith recommends that hospitals streamline the number of employees that might need to wear respirators to care for TB patients.2 That is what Lindesmith does at Gundersen Lutheran, which treats two or fewer TB patients a year. Out of 6,000 employees at the medical center, "our initial list had 1,000 people who might be exposed. We’ve cut that down to 300," he says. "That’s still way too many."
Yet hospitals around the country struggle with the initial fit test. "It’s very cumbersome to do the test," says Jill McElvey, RN, MSN, employee health coordinator at South Georgia Medical Center in Valdosta. "It’s real subjective whether the employee tells you they smell the saccharin."
Fit checking vs. fit testing
Is fit testing really necessary? Does it improve worker protection against TB? The answer is no, according to critics of the proposed TB standard, such as the Association for Professionals in Infection Control (APIC) in Washington, DC.
"Certified respirators and fit testing have not been established to be necessary in controlling TB transmission in health care facilities," asserts Rachel Stricof, MPH, a member of the APIC TB task force and an epidemiologist in the New York state Department of Health in Albany. "That is not to say that respiratory protection may not be necessary," says Stricof. "The air in the room of an infectious TB patient may pose a significant risk to persons entering, and therefore, some level of respiratory protection should be used. The question is, how much is enough? And what can be done to increase the likelihood that workers use the respiratory protective device properly?"
Stricof argues that simple fit checking, in which workers check the seal, and efforts to improve comfort and use of respiratory protection are more important than fit tests. In a survey of 41 nurses at a hospital that had experienced a TB outbreak, Stricof and her colleagues found that 42% of respondents were not consistently wearing the respirators "in an appropriate manner."3
APIC’s criticisms of fit-testing dovetailed with the IOM report, Tuberculosis in the Workplace, which recommended that fit-testing requirements be linked to the level of TB risk. The report noted studies that showed weaknesses
of quantitative fit tests. One study cited by the panel indicated that education and fit checks were more effective than fit tests.
"There was concern about overreliance on fit testing," explains IOM panel member Scott Barnhardt, MD, MPH, medical director of Harborview Medical Center in Seattle. "But there was equal concern that for respirator programs to be effective and not provide workers with false reassurance of protection, you needed to have reasonable respirator programs that include components of education and training of the workers and fit testing. It really was a matter of balance."
Wagner notes that NIOSH researchers are continuing to investigate the effectiveness of fit tests. He agrees with the IOM panel that more work needs to be done with manufacturers to create better-fitting respirators in general. "I welcomed their finding and suggestion that attention should be paid to the inherent fitting characteristics of respirators," he says. "Overall, I thought the report was supportive of the need for worker health protection, and supportive of the potential of an OSHA rule to be able to contribute to that."
Meanwhile, beyond the controversies surrounding fit testing, one consensus emerges: Despite declining TB rates nationwide, hospitals need to maintain vigilance in identifying and isolating TB patients. "The major failure in the 1980s [when TB outbreaks occurred] was relaxing the vigilance with which we tried to identify and isolate patients, both on an outpatient basis and an inpatient basis," says Barnhardt.
[Editor’s note: Detailed information on establishing a respiratory protection program is available in the NIOSH Administrator’s Guide (Publication 99-134). NIOSH also has created an instructional video, "Respirators: Your TB Defense" (video library #214), available from the NIOSH Publications Office via e-mail ([email protected]). Web site: www.cdc.gov/niosh/nioshmail.html. Telephone: (800) 35-NIOSH or (800) 356-4674.]
References
1. Field MJ, ed. Tuberculosis in the Workplace. Washington, DC: National Academy Press; 2001.
2. Lindesmith LA. "Tuberculosis Control and Respiratory Certification for Health Care Workers." In: Orford RR, ed. Occupational Health in the Health Care Industry (Clinics in Occupational Medicine). Philadelphia: WB Saunders; 2001,
pp. 1-16 (in press).
3. Stricof RD, Delles LP, DiFerdinando G. Mask/particulate respirator use by employees at risk for exposure to multidrug resistant tuberculosis. Presented at the ALA/ATS International Conference. Boston; May 1994. n
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