Congress halts the enforcement of annual tuberculosis fit-test rule

Long-awaited TB guidelines skirt fit-test issue

Federal enforcement of the annual fit-testing requirement has been halted for at least a year, as Congress intervened in the tuberculosis-related rule. Meanwhile, new draft federal TB guidelines leave some ambiguity by recommending periodic fit-testing, while acknowledging regulations that require annual fit-testing.

A provision in the huge federal appropriations bill that passed in late November prohibits the U.S. Occupational Safety and Health Administration (OSHA) from spending federal funds to enforce the General Industry Respiratory Protection Standard annual fit-testing requirement as it applies to TB. It only applies to FY 2005, which runs to Oct. 1, 2005, and actually does not revoke the rule, which went into effect July 2.

The action doesn’t resolve the contentious debate over the fit-testing rule. In fact, it actually will have little effect, says Bill Borwegen, MPH, health and safety director of the Service Employees International Union (SEIU). "There’s going to be a lot of confusion. People are going to think the respirator rule doesn’t apply. That’s not the case."

State plan states will be able to use state money to enforce the annual fit-testing rule, he notes. And as it is an existing regulation, the Joint Commission on Accreditation of Healthcare Organizations will expect hospitals to follow it, Borwegen says.

"If it’s still a regulation, the Joint Commission will still require compliance with all applicable law and regulation," acknowledges Mark Forstneger, JCAHO spokesman.

The Association for Professionals in Infection Control and Epidemiology (APIC) and the American Hospital Association sought congressional relief from the annual fit-testing rule, which they contend places a great burden on hospitals but provides little benefit in employee protection.

Jennifer Thomas Barrows, APIC’s director of government and public affairs, notes that the halt in enforcement is just a stop-gap measure.

"This was designed to hopefully provide an important window of time during which we can continue to work with our public health and health care partners to ensure effective strategies for addressing health care worker protection from airborne pathogens from infectious patients," she says. "APIC wholeheartedly supports scientifically proven methods for protecting workers and will continue to advocate for measures that are both necessary and effective."

Industrial hygienists assert that fit-testing is necessary to ensure respirators continue to provide the proper level of protection — and health care workers are not treated differently from employees of other industries.

Hospitals have been scrambling to fit-test hundreds of employees since OSHA revoked the TB-specific respirator standard Dec. 31, 2003, and stated that hospitals must comply with the General Industry Respiratory Protection Standard.

The ban on enforcement may have little effect for another reason: OSHA had not cited any employers in the first five months after the annual fit-testing rule went into effect. Richard Fairfax, OSHA director of enforcement programs, also notes the congressional action only applies to tuberculosis. Annual fit-testing still is required to protect health care workers from exposure to other airborne infectious diseases.

"If you’re a hospital worker and there’s a SARS [severe acute respiratory syndrome] outbreak, you would still be covered completely under 1910.134 [the General Industry Respiratory Protection Standard]," he says.

Meanwhile, the Centers for Disease Control and Prevention (CDC) released its long-awaited draft TB guidelines, which are available for public comment on its web site (www.cdc.gov). The draft guidelines took three years to develop and were delayed for months by a lengthy internal review at the CDC.

The most contentious issue is fit-testing. The National Institute for Occupational Safety and Health supports annual fit-testing, while other CDC divisions do not. The draft guidelines recommend periodic fit-testing based on a risk assessment, but note that OSHA requires annual fit-testing. They do not define periodic.

"There’s not a sufficient scientific base to make a recommendation," explains Michael Iademarco, MD, MPH, associate director for science in the CDC’s Division of TB Elimination. "Our final decision was to lay out the facts. . . . We’re giving infection control programs all the data and saying, You need to make a decision.’"

The CDC convened a workshop on fit-testing and respiratory protection in Atlanta with dozens of experts in industrial hygiene, infection control, epidemiology, and occupational health. Information from that meeting may lead to changes in the draft TB guidelines, he adds.

"The job of CDC is to look at the public health science and make the best public health recommendation possible," Iademarco says. "We’ll take this information and come up with the best recommendation possible."

He notes the guidelines also cover administrative controls, engineering controls, and other aspects of a respiratory protection program. "This contentious issue is only one small aspect of the third strategy [respiratory protection]."

The draft guidelines also address the use of the new QuantiFERON-TB blood test for testing health care workers and as a diagnostic tool.

With a revised risk-assessment protocol, it changes recommendations for the frequency of TB screening of health care workers and defines health care workers who need periodic TB screening. For many hospitals, the draft guidelines may decrease the screenings. For example, facilities at low-risk for TB should conduct baseline TB screening of employees but do not need to perform any further screening unless there is an exposure to TB, the draft guidelines state.

Hospitals with more than 200 beds would be considered low risk if they encounter fewer than six TB patients in the past year. Hospitals with fewer than 200 beds would be low risk if they encounter fewer than three TB patients in the past year.

California works toward consensus

Amid the controversy over fit-testing, a group in California is working toward a consensus on an airborne infectious disease standard.

Representatives of labor unions and hospitals found common ground by looking beyond tuberculosis and fit-testing, says John Mehring, health and safety educator with the SEIU Education and Support Fund in San Francisco. "We’re trying to take a more holistic approach and look at the whole spectrum of diseases," he says.

For example, at a recent meeting, the group discussed influenza vaccination and whether health care workers should be required to sign a declination if they don’t want the vaccine, as they do with hepatitis B. They talked about respiratory hygiene and whether that might be incorporated into a standard.

Even in the area of fit-testing, the committee found some areas of agreement. Too many people are included in the annual fit-testing at many hospitals, Mehring notes.

"In part, it’s because the nature of staffing in acute-care facilities today requires a great degree of flexibility on the part of management and workers," he says. "Perhaps, there needs to be a two-tiered approach. If we understand that the universe [of fit-testing] is artificially too large, how do we break that down into something that’s more realistic?"

The group will review the OSHA’s proposed tuberculosis standard, which the agency withdrew last year, and consider whether there are low-risk circumstances that would not require annual fit-testing.

Some California hospitals support the idea of a comprehensive standard on airborne infectious diseases, Mehring adds. Yet fit-testing still may prove to be a stumbling block. The creation of a standard will depend on the ability of the group to work out its differences.