Is OSHA softening on risk assessment?
Is OSHA softening on risk assessment?
More flexibility seen for low-prevalence areas
The Occupational Safety and Health Administration (OSHA) appears to be adopting a more flexible approach to its proposed TB standard. The agency may tailor requirements according to various levels of risk, a step that would leave hospitals in low-prevalence areas with less onerous requirements, says Amanda Edens, MPH, industrial hygienist at OSHA.
"We are looking at the range of risk and looking at the recommendations and some of the statements that were made in the IOM report about their concern that the previous proposal was a little inflexible," Edens says. "We are open to ways to make the standard more commensurate with the risk that exists. There was already some consideration for low-prevalence or low-incidence areas of TB [in the proposed rule]. But if the perception [of inflexibility] is there, we need to make it clear to people that if you are in areas that don’t have TB, you might have less to do."
The agency has also decided to leave the docket open for comments for three more months, extending the deadline until June 25, says Edens. That will let stake-holders continue to submit comments on two peer reviews OSHA published last month.
Expert: Risk categories need work
Indeed, OSHA will have to make its case much stronger if the agency expects to meet its regulatory threshold of finding that the hazard in question represents "a material impairment of health," says Katherine West, BSN, MSEd, CIC, infection control consultant for Infection Control/Emerging Concepts in Manassas, VA. "They have some tough hurdles," she says of the agency’s risk assessment proposal. "Their risk categories are not well-defined, and they haven’t accounted for different areas of risk within a facility. The [risk assessment] is based on 1998 data, and the case numbers have declined since 1998."
A second problem in the way risk is assessed stems from the way the agency has combined dissimilar types of TB, West adds. "They talk about TB in general, so that the numbers reflected are not just pulmonary TB," she explains. "They include atypical cases and extrapulmonary cases, but extrapulmonary cases are not communicable, and atypical TB is not a risk unless you are immune-compromised."
To avoid overstating occupational risk, infection control personnel doing a risk assessment for TB in their community should only ask the local health department for pulmonary TB case numbers, she recommends.
The best way to craft a standard that will stand up to critical review would be to partner with the CDC, West adds. The CDC is currently discussing changing recommendations for the frequency of skin tests and other measures in its 1994 guidelines, which formed the basis for the 1997 OSHA proposed rule. "OSHA should hold off and see what the [revised] CDC guidelines say," West says. "Then it can take CDC’s new guidelines and put them into regulatory language."
Indeed, many critics of OSHA say they would support the agency if it stuck to enforcing CDC guidelines. "Some hospitals need regulation," West admits. "Some of them need to be told that this is important to do."
Best to stick with CDC guidelines
That said, the agency should not exceed the reach of the CDC guidelines, because it won’t be able to justify a standard based on current TB trends, West says. "The numbers are continually dropping — plus, TB is treatable," she says. "In Third World countries, people [still] get TB and die. But I don’t believe that people in this country aren’t going to get picked up and treated today, especially not health care workers."
TB declined 7% in 2000 and has fallen a total of 39% since 1992. The early 1990s saw nosocomial TB outbreaks that prompted the proposed rule, but widespread improvements in public health and infection control efforts now appear to have TB on the run in the United States. At the same time, CDC epidemiologists are well aware that the history of TB shows that it resurges when prevention programs wane.
"I call it the paradox of prevention," says Renee Ridzon, MD, medical epidemiologist in the CDC division of TB elimination. "You do a really good job, then all the money goes away and you can’t do the prevention anymore. Then it could come back. People have this concern in their minds, although I hope it wouldn’t return to the state it was in the late 1980s and early 1990s."
With TB in decline, OSHA must make a case for regulatory "vigilance" if it pursues finalization of the standard. "A lot of things that we proposed are things you would still want to do even it you didn’t have TB [in your community]," Edens says. For example, even in low-prevalence areas, infection control personnel would want to have referral arrangements established if they do not have TB isolation rooms. Likewise, clinicians would have to be knowledgeable in diagnosis and treatment issues, should a case appear in the emergency room.
"The question is: How can we come together in a reasonable way to keep the vigilance and maybe not be so different from CDC?" she asks. "If OSHA had something in place, it would capture those people who have a tendency to go lax when things are going good. We could have a mechanism to make sure that we not being overly burdensome, so if [hospitals] are following the CDC guidelines, which most people endorse, then following an OSHA rule wouldn’t be any more burdensome."
The standard could be written in such a way that it would enforce CDC guidelines even if they are revised, Edens notes.
"Obviously, if they made huge changes in what they recommend for infection control practices, we would want to look closely at that and make sure we are both on the same page scientifically," she says. "If the only thing [the CDC] is changing is the periodicity of skin testing, that might not have a big impact on what we are doing. We could quite easily incorporate that. Some of the basic infection control procedures I don’t see changing."
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