OSHA New Year’s edict to hospitals: Fit test employee respirators annually

No TB rule — just new respirator rules for everyone

Hospitals received an unwelcome New Year’s present from the U.S. Occupational Safety and Health Administration (OSHA) in the form of a new mandate: They must update their respiratory protection programs and conduct annual fit-testing of any employee wearing a respirator for TB or any other reason.

In a move that caught some by surprise, on Dec. 31, OSHA revoked its TB-specific respiratory protection standard along with the proposed tuberculosis rule. That means hospitals now are covered by the respiratory protection standard that applies to general industry (1910.134), which requires annual fit tests for filtering face-piece respirators such as the N95.

"[I]t is appropriate and necessary to ensure that employees exposed to TB have the same protections as employees exposed to other types of hazards in the workplace," the agency stated in its Federal Register notice.1 "Fit-testing is necessary because a respirator that doesn’t fit properly provides only the illusion of protection."

OSHA initially made the requirement effective immediately, but then delayed enforcement until July 1. The standard provides more detailed requirements for medical screening, annual training, and record keeping, in addition to the fit-testing rule.

"Requirements such as annual fit-testing and medical evaluations for covered employees may be new for some employers," said John Henshaw, OSHA administrator, in a statement. "We want to make sure they are aware of these new requirements and give them every opportunity to be able to successfully come into compliance."

In fact, the respiratory protection requirements already were required for the use of respirators for anything other than TB. "Many hospitals already have this program in place. If they were using respirators for SARS [severe acute respiratory syndrome], ethylene oxide, or anything else, they should have had a program in place," says an OSHA respiratory hygienist.

Reaction to the change varied widely, as hospitals began reviewing their programs even while they questioned the need for annual fit tests.

"There is not a scientific basis for mandatory annual fit-testing across the board," says Jennifer Thomas, director of government and public affairs for the Association of Professionals in Infection Control (APIC) in Washington, DC. "It will be a tremendous logistical and financial burden for health care facilities."

Established respiratory protection protocols shouldn’t be altered for one industry, asserts Roy McKay, PhD, director of the occupational pulmonology services program at the University of Cincinnati College of Medicine and respiratory protection expert. "There may be a need to recognize differences in the types of respiratory protection, and manufacturers may need to consider developing different types of respirators to better accommodate special needs of health care workers. But to change protocols and guidelines that have been shown to be effective for respiratory protection programs doesn’t make any sense to me."

Annual fit-testing related to TB has been the subject of much debate since 1998, when OSHA established its updated standard for general industry but temporarily kept the old standard for tuberculosis. OSHA had planned to include updated respiratory protection rules in its TB standard and had solicited comments on fit-testing protocols, among other issues. Fit-testing became a lightning rod for critics of the proposed TB standard, such as APIC.

Last year, OSHA announced that it was rescinding its proposed TB rule because public health efforts had reduced the hazard significantly. Dec. 31, when OSHA formally revoked the TB rule, the agency also eliminated the temporary, TB-specific respiratory protection standard.

"[I]n order to provide protection, the respirator must fit the employee well enough to prevent leakage from occurring," OSHA said in the notice. "This is particularly important for a hazard such as TB that does not have any warning properties that would allow an employee to detect that it is being inhaled, [that is], there is no odor that might indicate a breakthrough."

Employee health professionals support the need to protect employees, but they question whether the same rules should apply for the use of disposable N95 respirators with chemical and biologic hazards. Occupational-based skin-test conversions have not been linked to improper respirator fit or use despite the recognized weaknesses of such devices, says Michael Hodgson, MD, MPH, director of occupational health program at the Veterans Health Administration in Washington, DC.

"Most of the PPD [purified protein derivative] conversions in health care workers do not occur in the setting of exposure to known patients but occurred through unrecognized tuberculosis patients elsewhere in the hospital. We have not found conversions in individuals using respiratory protection," he explains.

The Association of Occupational Health Professionals in Healthcare (AOHP) in Warrendale, PA, and the American Association of Occupational Health Nurses (AAOHN) in Atlanta have asked OSHA to create a respiratory standard for airborne biological hazards. They have not yet received a response.

"Biological issues are different from dust and gases," says Denise Strode, RN BSN COHN-S/CM, clinical case manager at OSF Saint Francis Medical Center, Center for Occupational Health, in Peoria, IL, and executive president of AOHP. "Health care is not a one-size-fits-all [profession]."

Hodgson worries that annual fit tests will absorb time and resources that instead could be focused on other hazards that lead to serious injury or even death, such as violent assaults or patient handling.

"There’s a hierarchy of how we build programs and assign resources," he says. "It’s not that respirators aren’t important. The question is: Does annual fit-testing with a rigorous protocol really give us that much bang for the buck?

Hodgson notes that the rules create "a huge additional workload" yet may not contribute significantly to the prevention of nosocomial spread of TB.

Meanwhile, APIC vowed to press OSHA to modify the new edict — or at least to provide a delay in implementation. In light of a decreased occupational risk related to TB, the action "contradicts the justification that Assistant Secretary [John] Henshaw gave for withdrawing the rule in the first place," says Thomas. "There is not a scientific basis for mandatory annual fit-testing across the board."

In the Federal Register notice, OSHA noted that the Respiratory Protection Standard withstood a legal challenge and was upheld by the 11th Circuit U.S. Court of Appeals.

Does it leak? Fit-testing only way to know

Yet that is not the viewpoint of experts in respiratory protection, who say that fit-testing is the only way to make sure a respirator is not allowing air to leak around the face seal.

The need to fit test large numbers of employees doesn’t change that fact, McKay says. Chemical manufacturers or petrochemical companies also fit test large numbers of employees, but simply consider it a part of doing business, he notes.

"Once you make the recognition that respiratory protection is needed, then you should not arbitrarily change respiratory protection guidance simply because you don’t like certain aspects of it," McKay explains. "Industry has shown these guidelines to be effective.

"The fit test provides us an opportunity to document and ensure that the respirator that’s being issued continues to fit, because of changes in weight and other changes over time," he adds. "You cannot determine if a respirator fits properly by looking at it."

In fact, exempting health care workers from the requirements of the general respiratory protection standard would have been "fairly outrageous," contends Bill Borwegen, MPH, health and safety director of the Service Employees International Union. Without it, health care workers would be treated in a "substandard fashion" compared to other workers. "Without that standard, there is no requirement that health care workers be medically evaluated and fit-tested, before we start counting victims," he says.

The need is even greater in the wake of SARS, Borwegen says. He acknowledges that many questions remain about how TB is transmitted and what role respirators play in preventing spread. "Therefore, the prudent approach is to protect people."


1. U.S. Occupational Safety and Health Administration. Respiratory Protection for M. Tuberculosis. 68 Fed Reg 75,776-75,780 (Dec. 31, 2003).