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Political change, IOM report, and emboldened foes
In what could be a major victory for infection control professionals, the proposed tuberculosis regulation by the Occupational Safety and Health Administration (OSHA) appears to have flat lined. And the standing orders may well be, "Do not resuscitate."
Even proponents of the embattled 1997 proposed regulation are questioning whether the agency will champion it again after the political shift to a Republican administration.
"I don’t think we are going to see a lot of action on this issue under the current administration," says Bill Borwegen, health and safety director at the Service Employees International Union (SEIU) in Washington, DC. The SEIU was one of the unions that lobbied hard for the standard, often facing off in hearings with infection control professionals who said OSHA was pursuing regulatory overkill for a disease in decline.
"The exciting news is, at least scientifically, what we said was correct," says Eddie Hedrick, MT (ASAP), infection control manager at the University of Missouri Hospital and Clinics in Columbia. Hedrick testified at an OSHA hearing in Chicago in 1998. "I think with a Republican administration, [OSHA is] liable to back down
on this for another four years. One of the things that I testified to was the inflexibility of this [standard]."
The 1997 proposed standard was dealt a
serious political blow when a scientific panel
of the prestigious Institute of Medicine (IOM) concluded that the regulation was inflexible because it would impose requirements that provide little additional protection in low-risk areas while adding significant costs and administrative burdens on health care facilities.
In addition, while warning that TB is still a threat to health care workers in certain situations, the IOM concluded that OSHA overestimated the progression of TB from infection to active disease, and from disease to death. (See related story, p. 36.) That means the standard was justified in part on OSHA projections that were "inconsistent with available data and are unlikely to fit employed workers with reasonably good access to health care."
The report was the result of a directive in November 1999 from Congress, which asked the IOM to examine the risk of TB among health care workers and the possible effects of federal guidelines and regulations intended to protect them. The IOM noted that the proposed OSHA standard was based on measures that were effective in reducing transmission of TB, and finalization would likely sustain and increase the level of adherence to TB control measures.
However, OSHA may have needed nothing less than a ringing endorsement from the IOM to overcome political changes and entrenched opposition. While the IOM panel noted some benefits of having a standard, it essentially called on the agency to create something very near an oxymoron — a flexible regulatory standard.
Citing ongoing political and agency changes, an OSHA spokesman declined to comment on the IOM report other than to confirm the agency was in receipt of it and would consider the findings.
Agency pursued other priorities
"Two of the three points that [the IOM] made in the report were supportive of the need to control this hazard through OSHA," Borwegen says. "By and large, it was a supportive report. [But] even though this study didn’t specifically say it would delay issuing the final rule, OSHA was sidetracked with the ergonomics rule and getting the needlestick regulations out. OSHA didn’t get around to getting the [TB rule] out, and now it is probably not going to come out in the next four years. I’d be surprised if it did."
Though acknowledging the political climate that OSHA faces, Michael Tapper, MD, an IOM panel member, emphasizes that the committee did not specifically recommend against issuance of a TB standard. "Obviously, OSHA is a regulatory agency, and all regulatory agencies exist in a political context in Washington," he says.
"We have a different administration now and a new secretary of Labor. I think that this is really going to play over the next couple of months. I don’t know what OSHA is going to do with it, but I think the committee made a point that it would support an OSHA TB standard. I don’t think the committee said that OSHA shouldn’t issue a standard," Tapper explains.
Yet if OSHA attempts to revive the proposed rule, it must address the concerns raised in the IOM report, negotiate a completely changed political landscape, and face down an emboldened opposition in Congress.
"I commissioned the study because of my fear that the OSHA regulations needlessly burdened hospitals and health care workers and that they would cause more harm than good," says Rep. Roger F. Wicker (R-MS). "I was pleased to see that the nonpartisan, scientific examination by the IOM reached the same conclusion about the inflexibility of the proposed guidelines."
His involvement can be credited to the Assoc-iation of Professionals in Infection Control and Epidemiology (APIC), which lobbied Wicker
to commission the study. In a statement posted on its Web site, APIC noted that the IOM report echoed many of its original concerns.
Kyle Steward, a press aide in Wicker’s office, adds, "We’ve got a new administration and maybe a different perspective on things. This is a nonpartisan study, and we hope that it will influence any decision making on the issue. We’re going to be right there on top of it, as it happens."
Steward says the future of the proposal within OSHA will depend in part on "the will of the folks who promoted it in the first place." Regardless, findings of an independent scientific panel carry political clout, he adds. "When agencies propose these standards, our position has always been What do the scientists say?’ Let’s make sure this is scientifically based instead of something that may be politically inspired. Let’s get this out of Washington and into the hands of folks who can study this objectively and let them tell us what may be the proper course."
The OSHA standard was proposed after a national resurgence of tuberculosis that included several nosocomial outbreaks in the early 1990s.1 However, epidemiologists and infection control professionals argued that the subsequent regulation was not needed because TB was already in decline due to public health and clinical measures — including the 1994 guidelines for health care settings by the Centers for Disease Control and Prevention.2
Can paper tiger’ enforce CDC guidelines?
The CDC guidelines are now being updated, but clearly contain the flexibility factor the IOM found lacking in the OSHA regulation.
"Those guidelines in 1994 were closer to what we were looking for," says Walter Hierholzer, MD, chairman of the IOM panel that reviewed the TB standard. "There should be some opportunity for very low-risk hospitals to have a much more constrained control program than very high-risk hospitals." For example, the OSHA standard did not tie infection control measures to risk levels like the CDC guideline system, he notes. "The 1994 CDC guidelines had a five-level risk standard. You modified your control program based on the risk you found. Since the risk is so widely varied in the country geographically, and within some worker classes in the hospital industry, we thought that it was reasonable that that ought to appear in a new OSHA standard."
To address such concerns, OSHA could — as many suggested from the onset of the protracted debate — use its "general duty" regulatory authority to simply enforce regularly updated TB guidelines by the CDC. "They still have
their general duty clause which they can apply," Hierholzer says.
Hedrick suggested the same thing in his OSHA testimony, and even developed a checklist to help OSHA accomplish the task. "The CDC said from the beginning that this is a work in progress and guidelines will change as the science and the disease change," he says.
"The [OSHA] document was inflexible, so we were trying to get them to use CDC guidelines."
While OSHA has taken an independent path in the past, working closely with the CDC may now be the best way for the labor agency to effectively address TB in health care settings, adds Katherine West, MSEd, CIC. West deals frequently with OSHA compliance issues as a consultant with Infection Control/Emerging Concepts based in Manassas, VA. "OSHA is not a medical entity; it is an industry-safety entity," she says. "This is a domain that I’ve never felt [it was] extremely knowledgeable about or comfortable even being in. Is it turfdom? I don’t know. But it would be a great if they worked together on this. It would be good for [OSHA]."
Still, proponents of the proposed standard, such as Borwegen, argue that even should OSHA take such a route, its general duty clause is "a paper tiger" that is much harder for the agency to enforce than a specific standard. "It’s very resource intensive," he says. "OSHA doesn’t have the resources and lawyers in place to litigate a lot of general duty clause citations, and I don’t think using the general duty clause is going to get the infection control practitioners the resources they need to deal with the problem."
Borwegen has long argued that a TB standard would help ICPs get funding for their programs. Unconvinced, ICPs are now calling for OSHA to finally throw in the towel on the issue, particularly since TB is in steep decline in much of the nation.
"I feel very strongly that they should drop it," says Susan Kraska, RN, CIC, an ICP at Memorial Hospital in South Bend, IN. "I am no more interested in having TB spread in my organization than the next person, but I have criteria that I have established based on what the TB incidence is in our community. Now did we all need an awakening and a kick in the pants? Of course, but do we now have to put people through fit-testing and spend money for N-95 respirators and HEPA filtered masks? It goes beyond what is necessary to control it."
Instead, she recommends that scarce health care dollars should go toward less expensive but effective interventions such as education geared toward rapid case identification, treatment, and patient isolation.
"I am hoping that common sense and logic will prevail," Kraska says. "It so infrequently does in the political arena. But I am hoping that the legislators are wise enough to know that if we are going to [preserve] health care dollars to do the most good, let the people who know how to stop communicable disease do their job. Don’t impede our ability to get that job done by adding additional tasks and expenses that are not necessary."
(Editor’s note: The full IOM report has been posted on your HIC subscriber Web site at www.HIConline. com.)
1. 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; 43:1-133.