IOM: OSHA’s TB standard suffers from a fatal flaw
Not enough flexibility for low-risk hospitals
The proposed U.S. Occupational Safety and Heath Administration (OSHA) standard on tuberculosis (TB) fails to provide enough flexibility to hospitals at low-risk and relies on outdated and flawed estimates of the TB threat, an Institute of Medicine (IOM) panel has concluded.
Although the panel endorsed the concept of a regulation to ensure that health care workers are protected, the report lodged stinging criticisms at key provisions of OSHA’s proposed standard.
In fact, even beyond creating administrative and cost burdens, false positives on screening tests at low-risk hospitals could lead to unnecessary treatment of health care workers, the panel stated. Those conclusions boost the strong opposition to the TB standard, although it is unclear what direct impact the IOM report may have on OSHA actions.
The Association for Professionals in Infection Control (APIC) in Washington, DC, lobbied Congress for funding of the IOM study and has consistently argued that the standard presented an unnecessary burden and a misdirection of resources. In fact, the IOM report reflects many of the concerns as well as the scientific background presented by APIC. "We believe that the findings of the IOM are consistent with the materials that we have been presenting to OSHA and the materials we presented to the IOM," says Rachel Stricof, MPH, a member of the APIC TB task force, who is an epidemiologist in the New York (state) Department of Health in Albany.
OSHA officials already had acknowledged that the final TB standard would differ from the proposed version on issues such as the frequency of respiratory fit-testing and skin testing. But while the release of the TB standard once seemed imminent, its future under a Republican administration is murky.
"The bottom line is we have a new regime," says Bill Borwegen, MPH, occupational health and safety director of the Service Employees International Union. "We’ll be lucky if we can save the regulations that have just been completed, let alone come out with some new ones."
When OSHA began working on a TB rule in 1994, TB cases were rising nationwide. Outbreaks occurred in several U.S. hospitals, including cases of the deadly multidrug-resistant strain. The Centers for Disease Control and Prevention (CDC) issued guidelines for preventing TB spread in health care facilities in 1990, then updated them in 1994. The CDC is now reviewing those guidelines with another update expected in 2002.
By the time OSHA published a proposed rule on occupational exposure in 1997, increased awareness and compliance with CDC guidelines contributed to a decline in TB spread. "The sense was that many hospitals had moved to deal with some of these issues," notes Michael Tapper, MD, chief of infectious diseases and hospital epidemiologist at Lenox Hill Hospital in New York City. Tapper also is a member of the IOM panel.
By 1999, seven straight years of declining cases led to a rate of 6.4 cases per 100,000 population, a 35% drop since 1992. To critics of the OSHA standard, that is proof that voluntary guidelines are sufficient. But the IOM panel cautioned against a repeat of the complacency that allowed TB to re-emerge in this country.
"It’s good news, but it’s also a warning not to reduce our vigilance," says Tapper. A standard provides a "legal and administrative framework to the guidelines." Moreover, it’s unclear how well prisons, homeless shelters, and other high-risk facilities are handling the TB threat, he says.
"You can look to the question of whether the current performance would continue without something firmer than voluntary guidelines," says Marilyn Field, PhD, senior program officer at IOM and the project director. "The committee’s conclusion was that an OSHA standard would at least sustain if not increase adherence with the tuberculosis control measures."
Did OSHA overstate workplace risk of TB?
Yet OSHA’s proposed rule presents problems that were outlined in detail in the 350-page report. Even OSHA’s justification for the standard is flawed; the proposed standard used inflated TB estimates, according to the panel.
OSHA predicted its rule would prevent between 1,477 and 1,744 cases of active TB among workers each year. "In its surveillance report for 1999, CDC lists a total of 551 cases of tuberculosis among health care workers and 16 cases among correctional facility workers," the report states. "This figure is less than two-thirds the number of cases that OSHA predicted would be prevented yearly by the implementation of its proposed rule. Moreover, of the reported cases of active disease, some proportion will have been the result of community rather than workplace exposure."
The panel was troubled by the lack of information about TB in other settings. "We had very little data, apart from acute care hospitals, to tell us the true incidence of TB infection and disease," says Tapper. "There are a lot of unknowns."
The panel particularly cited the need for better data and technical information on respirator fit-testing, noting potential problems with current methods of fit-testing. "The committee found no epidemiologic studies that have evaluated whether qualitative or quantitative fit-testing [either initial or annual] for N95 or other respirators used for tuberculosis control improves respirator fit in normal practice as workers treat, transport, guard, or otherwise have contact with people who have known or suspected tuberculosis," the panel said.
Meanwhile, the proposed standard would impose a burden on hospitals to provide respirators and fit-testing — even if they may not work, and even if the hospital rarely if ever encounters a TB patient, says Stricof. "Administrative and environmental controls have clearly been shown to be effective. What has not been shown to be effective are respirators and fit-testing programs."
The panel’s greatest concern, however, focused on the criteria for a facility to be labeled "low risk." Under the proposed OSHA standard, hospitals could not admit or provide medical services to individuals with suspected or confirmed TB. It must have had no confirmed cases of infectious TB during the previous 12 months, and it must be located in a county that has had no confirmed cases of infectious TB during one of the previous two years and less than six cases during the other year.
"Even if a facility had admitted no tuberculosis patients in the preceding 12 months, had no tuberculosis cases in its service area, and had a policy of referring those with diagnosed or suspected tuberculosis, that facility could not qualify for this lower risk’ category if the surrounding county had reported one case of tuberculosis in each of the preceding two years," the panel notes.
Those criteria are simply too strict, the panel states. The CDC guidelines provide a broader risk assessment, from minimal to high risk, and that risk assessment is likely to be reviewed in the agency’s guideline update. Assessment of risk should take into account a hospital’s service area and not the entire county, explains Field. "In some cases, the service area would be smaller than a county, other cases larger," she says.
If a hospital served only a portion of the county and had no TB cases in its patient population or service area, the hospital could fail to be designated as "low risk" simply because of cases elsewhere in the county.
"To the extent that an OSHA standard inflexibly extends requirements to institutions that are at negligible risk of occupational transmission of M. tuberculosis, the standard is unlikely to benefit workers at the same time that it would impose significant costs and administrative burdens on covered organizations and absorb institutional resources that could be applied to other, potentially more beneficial uses," the panel concludes.
[Editor’s note: A copy of the report is available on-line at www.iom.edu. A printed copy also may be ordered from the National Academy Press ($49), 2101 Constitution Ave., N.W., Box 285, Washington, DC 20055. Telephone: (800) 624-6242 or (202) 334-3313. Web site: www.nap.edu.]
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