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OSHA stands firm on need for standard, but mulls changes in key provisions

OSHA stands firm on need for standard, but mulls changes in key provisions

Compromise emerging, but OSHA not wavering on need for regulation

With the last national hearing on the Occupational Safety and Health Administration's proposed tuberculosis standard recently concluding in Chicago, it appears that months of heated debate may result in a compromise document that could be more acceptable to infection control professionals.

Acknowledging "persuasive" arguments by a spirited opposition that has included many ICPs, OSHA is considering key revisions that could include cutting back controversial provisions for worker TB skin testing, modifying medical removal protection, and dropping a demand for new TB isolation signage, Hospital Infection Control has confirmed.

The changes should move the final OSHA standard closer to the widely accepted TB guidelines by the Centers for Disease Control and Prevention.1,2 Nevertheless, ICPs testifying in Chicago urged OSHA to close the remaining gap between the agencies by incorporating the CDC risk assessment approach to allow local flexibility on infection control measures. Those who testified at any of the OSHA hearings have until Sept. 4 to submit any final comments in response to questions raised or comments made at the meetings. Those comments will be added to a docket on the proposed rule that includes some 1,300 submissions, which OSHA will review in an internal revision process that could result in issuance of a final TB standard in about 18 months, says Amanda Edens, MPH, industrial hygienist in the OSHA health standards program in Washington, DC.

"We're not at the end of the process yet, so a lot of things can happen in terms of final decisions," Edens tells HIC. "[But] there were some areas where we found some of the arguments kind of persuasive."

For example, OSHA appears ready to back off some of the TB skin-testing provisions that many warned would be expensive and potentially harmful to the very workers the agency is trying to protect. The proposed provisions include testing workers every six months if they enter TB isolation rooms and using two-step baseline skin testing for all workers with a prior negative skin test. Many ICPs have noted that increasing frequency of skin testing in low-risk populations may lead to false-positive test results and inappropriate administration of potentially toxic TB drug therapy. As a result, OSHA is considering reducing the two-step testing requirements to cover only certain worker populations and allowing testing less frequently than every six months.

"During the hearings, even people who didn't like the six-month testing across the board agreed that there were some areas where six-month testing might be appropriate." Edens says. "We share some of the same concerns that some of those individuals expressed, which was the potential for causing more false-positive skin-test reactions and then putting people unnecessarily on preventive therapy, which may have some risk of its own. We don't want to do that, of course."

In addition to the skin-testing requirements, OSHA is considering reworking a controversial provision requiring up to 18 months of compensation and worker benefits as part of "medical removal protection" for TB infection. Several ICPs have noted that the proposal appears to circumvent standard workers' compensation programs and fails to distinguish between nosocomial and community-acquired TB. At an April 7, 1998, OSHA hearing in Washington, DC, Adam Finkel, ScD, CIH, OSHA director of standards, said the agency may consider "whether it might be appropriate - and if so how - to modify that provision so that there could be an option for a medical determination that the TB infection is not work-related."

Russell Olmsted, MPH, CIC, an ICP at St. Joseph Mercy Hospital in Ann Arbor, MI, reminded at the final hearing in Chicago that such specific case management provisions are not really needed in the standard because more than 85% of patients taking anti-tuberculous medication become culture-negative within two months of therapy.

"I remain unconvinced that 18-month provision of full benefits is needed except in a rare instance involving disease caused by a multidrug-resistant strain," he testified. "This could instead be managed as a workers' compensation issue. In about 5% of all infected persons, disease occurs within one year. In another 5%, disease will develop later over the course of their lifetime. The remaining 90% remain infected but free of active disease. Receipt of isoniazid preventive therapy can reduce the risk for progression to TB disease by more than 90%. All of these facts argue against inclusion of specific case management components in this proposed rule. "

Reiterating a concern expressed by other ICPs, Olmsted also noted that OSHA's proposed TB patient isolation sign would be redundant with existing signage and possibly confusing.

"Many facilities, ours included, use the current CDC recommended terminology 'airborne precautions,'" he said. "An additional special symbol or sign might invite confusion, and I am not sure uniform agreement on signage is achievable."

OSHA is expected to revise the sign requirement, with Finkel noting in his statement that some of the objections against new signs are "persuasive."

Standard needed for 'continued vigilance'

While certain revisions may be forthcoming, OSHA does not appear to be wavering on the need for the standard itself. The nation's two major health care epidemiology groups - the Association for Professionals in Infection Control and Epidemiology (APIC) and the Society for Healthcare Epidemiology of America (SHEA) - have strongly questioned the need for new federal regulation due to the continuing decline in national TB incidence and evidence that current control measures are working. SHEA also noted that the proposed standard lacked credibility in the scientific community and APIC observed that OSHA was addressing a threat that has clearly passed. (See HIC, June 1998, pp. 81-85; April 1998, pp. 58-60.)

OSHA officials counter that some health care facilities have not adopted the CDC guidelines, and a TB standard is also needed to provide ongoing protection for health care workers even if U.S. incidence continues to wane.

"There is this issue of continued vigilance." Edens tells HIC. "We would like to think what happened in the past won't happen again. Certainly, what we have learned from the past is that when TB went down, people kind of dismantled their TB programs and didn't think about it that much [until] it popped back up. We would like to play a role in making sure that doesn't happen again."

With some form of standard all but inevitable, one of the more outspoken critics of the proposal took a more conciliatory position in official testimony in Chicago. Testifying as an individual ICP rather than as chairman of the APIC TB task force, Eddie Hedrick, MT(ASCP), CIC, conceded that there may be some need for a standard while emphasizing that OSHA should essentially enforce the CDC guidelines.

"I probably upset some of my colleagues," he tells HIC. "But [OSHA] spent millions of dollars on this and they are not about to just can it. And, what you find is that there are [facilities] out there who are not providing basic protection to their people. So I am assuming there is going to be a standard but that standard should not differ from the CDC guidelines. But no standard at all? We are probably going to lose that battle."

Hedrick included a sample checklist for OSHA inspectors to review, which outlines some of the major components of a TB control program as defined in the CDC guidelines. (See form, p. 115.) By using such a tool, an OSHA inspector could evaluate a hospital to ensure that an appropriate TB program is in place based on the CDC facility-specific risk assessment, Hedrick explained.

"By using the CDC Guideline as the basis for OSHA inspections you will calm the storm of opposition which has resulted from the liberty that OSHA has taken in modifying the scientific aspects of the CDC document," Hedrick testified. ". . . If OSHA were to use the actual CDC guidelines as the primary basis for the OSHA TB standard we believe that most in the health care community would be supportive of the regulation."

Respirators still a sticking point

In addition, Hedrick urged OSHA to drop some of the proposed TB respirator fit-testing provisions, noting that such programs designed for industry would be difficult to implement in health care settings. Reminding OSHA officials that TB was not addressed when the agency revised its respiratory protection standards for chemicals and toxins, Hedrick said the agency should now be consistent and treat TB differently as an infectious agent.

"It also is an opportunity to implement respiratory protection provisions which can be practically implemented in the health care environment," he testified. "Neither fit testing, nor fit checking as defined by OSHA should be mandated."

Testifying at the same hearing in Chicago, Judene Bartley, MS, MPH, CIC, a consultant with Epidemiology Consulting Services in Beverly Hills, MI, also urged OSHA to provide a more clear and direct statement allowing individuals to opt out of refitting for respirators when undergoing annual reassessment for TB infection or skin testing. Furthermore, there are data questioning the benefit of initial fit testing rather than an employee education and fit-checking approach, she added.3

Accommodating local variation

Bartley also urged OSHA to incorporate more aspects of risk assessment and local variation. For example, even in 1993 with the TB case rate at its peak, 45% of Michigan's TB cases were in Detroit - where only 11% of the state's population live, she noted.

"Clearer accommodation for variation should be supported, considering the wide range of TB risk, and based on the type of setting and geographic location," she testified.

While it is unclear whether OSHA will go so far as to incorporate the CDC risk assessment approach, which triggers a hierarchy of controls based on TB prevalence in the patient population and other factors, Edens emphasizes that the revisions under consideration are moving the standard closer to the CDC guidelines.

"We have felt all along that we are not that far away from the CDC guidelines," she says. "We do incorporate a lot of the same basic infection control measures that the CDC recommends, and really, we allow for some flexibility too. We tried to tailor the standard so that the people doing the most risky type of activity - isolating people and doing high-hazard procedures - have to do more in terms of engineering controls. The major area where we differ is really the skin-testing frequency. So if we were to go to something like an annual skin-testing frequency, we would become even more like the CDC guidelines."

Whether the revisions will be enough to appease the infection control community remains to be seen, but with the hearings over and only final comments coming in, OSHA appears to be closing the door on further debate. In that regard, the agency remains cool toward APIC's request to seek the counsel of a scientific advisory panel of TB experts before a standard is finalized. Edens says in suggesting a final review by an ad hoc expert panel, APIC is essentially requesting a repeat of the review and comment process that is now winding to a close.

"I don't necessarily know what would be gained by that right now other than just pushing it further and further into the future," she says.

References

1. Department of Labor. Occupational Safety and Health Administration. Occupational exposure to tuberculosis; proposed rule. 62 Fed Reg 54,160-54,307 (Oct. 17, 1997).

2. Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care facilities, 1994. MMWR 1994; 43:(No. RR-13) 1-133.

3. Hannum D, Cycan K, Jones L, Stewart M, et. al. The effect of respirator training on the ability of health care workers to pass a qualitative fit test. Infect Control Hosp Epidemiol 1996; 17:636-640.