APIC challenges proposed OSHA TB standard
Requests deadline extension for comment
The tuberculosis standard proposed by the Occupational Safety and Health Administration (OSHA) overstates the risk to health care workers and drastically underestimates the cost of compliance by health care facilities, charges the Association for Professionals in Infection Control and Epidemiology (APIC).1
"We have a lot of concerns," says Eddie Hedrick, MT(ASCP), CIC, chairman of the APIC TB committee. "Unfortunately, many of the concerns we expressed in the past still exist in this document."
In addition, Washington-based APIC has joined a cadre of medical groups including the American Hospital Association in Washington, DC, and the Society for Healthcare Epidemiolgy of America in Woodbury, NJ, in requesting an extended comment period to review the 147-page proposal. The groups sent a joint letter requesting an extension of a least 30 days beyond the current Dec. 16, 1997, comment deadline due to the "complexity and far-reaching implications of the proposal." OSHA has not decided whether to grant the extension but is expected to, as this issue went to press. Slated for a series of public hearings beginning in February, the standard was published in the Oct. 17, 1997, issue of the Federal Register.
OSHA claims the long-awaited standard, as proposed, would prevent 21,000 to 25,000 occupational infections and 138 to 190 TB deaths annually at an average annual cost of only $2,400 per facility. (See standard highlights and cost charts, p. 6.) While incorporating many elements of the Centers for Disease Control and Prevention’s TB guidelines, the proposed OSHA standard differs in several key areas.2 For example, the OSHA proposal drops the CDC facility risk assessment model, instead requiring employers to conduct an "exposure assessment" to determine which employees will have "reasonably anticipated" occupational exposures to TB. The standard then specifies the provisions applicable for the employees whom the employer has identified as having occupational exposure.
In addition, some OSHA skin-testing requirements go beyond those recommended by the CDC. For example, OSHA would require that workers who enter TB isolation rooms be skin-tested every six months. The requirement would apply even in facilities determined to be at "low risk" under the CDC guidelines, which call for annual skin testing in such settings. However, long-term care facilities or other settings that do not routinely admit and treat TB patients need not comply with many of the provisions if they set up arrangements to transfer suspected cases within five hours.
Validity of data questioned
According to an APIC statement released shortly after the standard was published, OSHA’s estimations of potential infections prevented and lives saved as a result of the rule’s implementation are not based on scientifically valid data.
"It is based on a mathematical model, but they have failed to consider one particular issue," Hedrick says. "They failed to understand that if somebody converts a skin test, they are going to get treated that’s why we monitor them. If you treat them, there is a 10% risk [of developing active disease] and no risk of dying."
In addition, APIC warns that "OSHA appears to have overlooked elements of the scientific literature, drawing conclusions inconsistent with those that the data support. In addition, APIC believes that OSHA has drastically underestimated the costs associated with the implementation of this rule, posing a serious threat to facilities facing budgetary constraints."
By contrast, guidelines issued by the CDC in 1994 are practical, based on science, proven to be effective, and have been implemented in health care facilities throughout the country, APIC argues.
"We have made significant strides in the battle against TB," says APIC President Candace Friedman, MT(ASCP), MPH, CIC. "It is both unfortunate and ironic that this burdensome and costly proposal comes at a time when the rate of TB in the United States is at an all-time low. If this rule is adopted, the diversion of funds away from patient care and into regulatory compliance with little effect on TB prevention may have a significant negative impact on the quality of care."
APIC has been lobbying Congress to quash the proposal before it becomes finalized, though rarely have such efforts been successful after a proposed OSHA rule has been issued. But APIC contends that the changing nature of infectious diseases makes it imperative that guidance from any agency be flexible and continually updated to reflect changing trends in the occurrence and distribution of diseases such as tuberculosis, as well as their methods of control. The structure of the current CDC guidelines provides this necessary flexibility, but a "static" OSHA regulatory standard will not, APIC argues.
Likewise, the cost may actually be five to 10 times higher than estimated for hospitals that have to comply with the majority of the requirements in the proposed rule, Hedrick says. The increased skin test requirements alone would have a dramatic impact because hospitals that treat TB patients will have to test more employees more frequently in the absence of the CDC risk assessment, he says. For example, instead of testing workers annually, some facilities may have to opt for testing a majority of workers every six months because it is impractical and potentially discriminatory to designate that only a certain pool of workers can enter TB isolation rooms, he notes.
"Just to increase the skin test frequency [to every six months], I will have to hire a full-time person," he says. "So that’s $35,000 to $40,000 without benefits, and they’re telling me that it is only $2,000 for the whole institution."
From OSHA’s perspective, however, an employer should know which workers do which tasks and whether their duties include entering TB isolation rooms or conducting procedures that put a worker at risk for transmission of TB, says Amanda Edens, MPH, industrial hygienist in the OSHA health standards program in Washington, DC. For example, respiratory therapists may enter TB isolation rooms at a given facility as part of their routine jobs; they would need be supplied with respirators and TB training and be skin-tested every six months, she notes.
OSHA open to new data, revisions
While defending the validity and scientific basis for the cost and risk estimates, Edens also emphasized the agency is open to reviewing any data submitted by APIC and possibly revising the proposed standard.
"If we look at that and they have better data, we can refine the risk assessment," Edens says. "You have to also remember we are trying to prevent infections. We consider that a material impairment of the worker’s health. It’s probably true that a lot of health care workers get preventive therapy and don’t go on to develop disease. OSHA’s concern is that people prevent the infection in the first place, not just the progression to disease."
Likewise, the cost estimates, which are based in part on assumed levels of existing compliance with the CDC guidelines, are open to review and revision before the rule is finalized, she adds.
"If there are areas where they feel we didn’t cost out the right respirator or we misinterpreted how much they pay their employees, those are all legitimate comments to make," she says. "The purpose of having the comment and rule-making period is so we can get the data. To the extent that is not correct, this is their chance to give us some advice."
Still, there are lingering elements of a "culture clash" between infection control and industrial hygiene that first became evident during the debate over the OSHA bloodborne pathogen standard in the 1980s. The principal difference appears to be that while OSHA must legally gear its efforts to protecting the worker, ICPs invariably must balance the worker’s safety with the patient’s well-being.
"The thing that came across strikingly to me is that they are trying to limit the amount of time [workers] spend in TB isolation rooms," says Julia Wendt, RN, BSN, CIC, infection control nurse at University Hospitals of Cleveland. "The patients in isolation already feel isolated, and they hate it. I realize OSHA’s point is to protect the worker, but we are working with patients, too. To limit that makes it sound like they are some awful pariah. [OSHA] also says minimize the time the patient is out of the room. We had somebody here for five months with TB. Wearing a mask and going outside was the biggest thrill for him."
Essentially, OSHA followed the example of the hazard exposure concept used in industry to recommend that several tasks might be combined, for example, rather than sending in three workers to do three different tasks, Edens says.
"We don’t want patient care to suffer. But to the extent that it doesn’t affect the care of the patient, try to think of ways to limit [exposures]," Edens says. "We are just trying to encourage them to think of ways that they might be able to do those kinds of things. It’s kind of a different perspective in terms of industrial hygiene and infection control. There are some clashes, but I think we are starting to come together a little bit. Some basic things we do in industrial hygiene are equally applicable in a health care setting."
While drawing fire from ICPs, OSHA also expects comments from those who question whether the rule is sufficiently stringent to protect health care workers and why it has taken years just to get a proposal on the table. OSHA was first petitioned for a permanent standard for occupational exposure to TB in August 1993 by a coalition of labor unions that included the Services Employees International Union (SEIU) in Washington, DC.
"We think that it is really sad that it has taken this long to simply get a proposal out," says Bill Borwegen, health and safety director at the SEIU. "We know there are proactive employers out there who have good infection control programs in place and are already following the CDC guidelines. But the purpose of a standard is to deal with a large number of folks who are continuing to take the low road. That is why OSHA exists."
Regarding APIC’s opposition, Borwegen argues that the standard might actually help ICPs in terms of job security and additional resources for their programs.
"If they are overwhelmed, management is going to have to hire somebody to help them even if they are downsizing and restructuring," he says. "The threat of OSHA is going to help [ICP] job security. Our biggest gripe has been we are incapable of enforcing the CDC guidelines, and this goes a long way in doing that."
Indeed, the close similarity between the proposed OSHA rule and the CDC guidelines provides "a consistent message" from the two federal agencies, says Gina Puglise, RN, MS, Chicago-based infection control consultant for the American Hospital Association.
"We support efforts to control TB and are pleased that the standard followed many of the recommendations from the CDC," she says. "However, there are a couple of areas that go beyond what the CDC does in the area of skin testing. And we do not agree with the CDC or OSHA on ultraviolet [irradiation] or portable HEPA [filters] only being supplemental to other engineering controls. We have never agreed with that. We think these are cost-effective alternatives, and there is data to support their use."
Concerning skin testing, the OSHA standard would also require more provisions for "low-risk" facilities than the CDC risk assessments because OSHA would require baseline two-step skin testing for employees, she says. In addition, OSHA keys its risk assessment on the presence of TB in the local county rather than the in the patient population, she notes. Despite the differences, the standard essentially provides an enforcement mechanism for the CDC guidelines, she notes.
"There is evidence that the hepatitis B rates have gone down following the [OSHA] bloodborne pathogen standard because of immunization," she says. "Whether the standard was cost-effective or whether that could have been achieved without the standard, I don’t know if we know."
Regardless, OSHA is already able to enforce many of the measures under its general duty clause, but there will be some additional requirements with a specific standard, she says.
"Under the general duty clause, [OSHA] can only cite if there is a hazard," she says. "And if you haven’t had any TB cases, there is no hazard, so you wouldn’t be required to do baseline skin tests. So the standard does impose requirements that would not be able to be done under the general duty clause. But for the most part, all of the other requirements are consistent with the CDC. So there really isn’t a big difference in what OSHA is going to be doing."
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.
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