OSHA may try to salvage less burdensome’ version of TB reg for health care
But agency stumbles again on risk assessments
Scalded by critics for its rigid regulatory approach in the face of declining tuberculosis, the Occupational Safety and Health Administration (OSHA) is now considering pursuing a more flexible standard to protect health care workers from occupational TB, Hospital Infection Control has learned.
"If we have a final rule, it is likely to be very different from the proposed standard," says Amanda Edens, project officer for the OSHA TB standard in Washington, DC. "There are things that we could change if we decided to proceed with the final standard."
As a first step in that process, OSHA has reopened the rule docket to allow review and comment on the agency’s revised draft TB risk assessment document. (To see OSHA risk estimates, click here.) In response to criticism of the risk assessment in its original 1997 rule, OSHA updated its risk projections based in part on 1998 data. Dated July 23, 2000, the draft risk assessment apparently fell into limbo as the agency’s efforts to finalize the rule were stymied by resistance from the infection control community and its political allies.
In addition, two peer review analyses of the risk assessment also are included, as is a report issued last year by the Institute of Medicine (IOM). Dealing the proposed standard a serious blow, the IOM report concluded that the regulation was inflexible because it would impose requirements that provide little additional protection in low-risk areas while adding significant costs on health care facilities. When a subsequent change in presidential administration appeared to bolster the position of OSHA’s existing political opponents, most observers said the proposed standard was dead in the water. OSHA begs to differ.
"It is on the latest regulatory agenda, and it is listed as a proposed rule," says OSHA spokesman Bill Wright. "There were quite a few things that were in the last regulatory agenda that have been dropped. This is not one of those. It is still a major issue on OSHA’s radar screen." Thus, five years after it was originally proposed, the OSHA TB standard has been revived with the limited reopening of the docket. Infection control professionals have until March 25 to submit any comments on the risk assessment and other material placed in the docket. (For comment information, see editor’s note at the end of this article.)
"We are looking at all the pros and cons of a standard," Edens says. "Obviously, there [are some who feel] that they are doing a really good job and there is really no need for an OSHA standard. I have talked to a lot of people, and there are people who have excellent TB programs. And there are some who don’t."
The primary problem that OSHA faces in pursuing finalization of the rule is that its own peer review experts — while saying many positive things about the risk draft — concluded that OSHA overstated the threat to health care workers. Though personally in favor of an OSHA TB standard, reviewer Mark Nicas, PhD, professor of public health at the University of California in Berkeley, tells Hospital Infection Control: "In the way they did the calculation, they overstated the lifetime occupational risk of infection and they also overstated the lifetime probability of disease. Clearly, if they have mortality figures based on their disease estimates, then there was some overestimation in mortality."
Also in the docket is an analysis of OSHA’s risk assessment by Richard Menzies, MD, professor and director of the respiratory epidemiology unit at McGill University in Montreal, Canada. He concluded, as well, that the "risk of death is overestimated. Age-specific case fatality rates are available from the literature or could be precisely calculated using national reported data from 1996-1998 that should be readily available from the Centers for Disease Control and Prevention [CDC]. These age-specific case fatality rates should be used to calculate risk of death for health care workers who develop disease within two years following occupational infection."
According to OSHA’s calculations, estimates of risk of death caused by occupationally acquired TB range from 0.1 per 1,000 for hospital workers in low-risk communities to 3.4 per 1,000 for workers in hospitals lacking enhanced controls and treating more than 100 TB patients per year. OSHA historically has used risk of mortality of one in 1,000 as a general rule of thumb for issuing regulation, says Edens. Though the one in 1,000 ratio falls within the risk estimates, the reviewers’ observations and other comments will have to be considered, she says. Moreover, any decision to finalize the rule could be based as much on political considerations as risk calculations.
"The risk assessment is merely a kind of mathematical exercise, looking at the data and trying to crunch out the risk estimates," she says. "The next step is a mixture of a science and policy. We haven’t gone to that stage yet, but those are the kind of determinations we will be making before the final rule. To some degree, it is a policy decision by the agency."
The agency is considering tailoring the regulatory requirements according to various levels of risk, leaving some hospitals in low TB areas with less onerous requirements. "We are trying to look 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 OSHA’s pervious proposal was a little inflexible," Edens says. "We are open to ways to make it commiserate 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 if you are in areas that don’t have TB, you might have less to do."
Indeed, OSHA will have to make its whole case a lot clearer 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. A longtime OSHA expert, West reviewed the risk assessment and other materials in the reopened docket for HIC. "They have some tough hurdles," she says. "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."
An additional concern is that the agency combined dissimilar types of TB in creating its occupational risk data, she says. "They talk about TB in general. The numbers reflected are not just pulmonary TB. They included atypical cases and extrapulmonary cases. Extrapulmonary cases are not communicable, and atypical TB is not a risk unless you are immune-compromised." To avoid overstating the occupational risk, ICPs doing a risk assessment for TB in their community should ask the local health department for only pulmonary TB case numbers, she recommends.
Lacking critical medical expertise, OSHA must partner with CDC if it expects to ever issue a standard that will stand up to critical review, West says. The CDC is currently discussing modifying the frequency of skin-test recommendations 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 CDC [revised] guidelines say," she says. "Then it can take CDC’s new guidelines and put them into regulatory language."
Indeed, many critics of OSHA from the outset said they would support the agency if it stuck to enforcing CDC guidelines. "Some hospitals need regulation," West says. "Some of them need to be told that this is important to do."
That said, the agency likely will fail if it tries to go beyond CDC guidelines because OSHA will not be able to justify a standard based on current TB trends, West says. "The numbers are continually dropping — plus, it is treatable. In Third-World countries, I believe that people get TB and die. But I don’t believe that people aren’t going to get picked up and treated in this country today, especially not health care workers."
The paradox of prevention’
Issuing a final rule will be a tough sell because TB declined 7% in 2000 and has fallen a total of 39% since 1992. The early 1990s saw the nosocomial TB outbreaks that prompted the proposed rule, but now widespread public health and infection control efforts have TB on the run in the United States. But at the same time, CDC epidemiologists are well aware that the history of TB is 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 very low TB prevalence areas, ICPs 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 department.
"The question is: How can we come together in a reasonable way to keep the vigilance and maybe not be so different from CDC?" Edens 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 overburdensome, so if [hospitals] are following the CDC guidelines, which most people endorse, then following an OSHA rule wouldn’t be anymore 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."
Currently, in addition to their own compliance documents, OSHA inspectors have a copy of the 1994 CDC guidelines for reference. Though they only can use the agency’s General Duty clause for enforcement in the absence of a TB standard, there are certain things they are enforcing, Edens says. For example, OSHA currently can require that initial fit tests be done on employees using N95 TB respirators, but the agency has no authority to require annual fit-testing unless it issues a final TB standard.
"We will do an inspection," she says. "But, generally, it is part of bloodborne pathogen standard inspection or if we get a complaint. We are not scheduling them necessarily. If they don’t have a TB case or have not had one in the last six months, we cannot prove a hazard exists. However, if we go into a hospital setting and they have TB patients, but are not using feasible means of abatement, then we would cite them."
[Editors’ note: The recently opened TB rulemaking docket H-371 — including the peer reviewer’ reports, OSHA’s draft final risk assessment, and the IOM report — are available for inspection and copying in the agency’s docket office in Washington, DC. The materials are not available on line, but according to Wright, the docket office will mail them to those who call (202) 693-2350. OSHA has set a postmark deadline of March 25, 2002, to receive comments on the docket items. You also may submit comments electronically to http://ecomments.osha.gov. Comments of 10 pages or fewer may be transmitted by fax to (202) 693-1648, provided that the original and one copy of the comments are sent to the docket office immediately thereafter. Comments submitted electronically or by fax must be submitted by the March 25 deadline. Send two copies of your comments to Docket Office, Docket H-371, Room N-2625, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Ave., N.W., Washington, DC 20210.]
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