OSHA may relent on hearing demands to change TB skin-testing frequency
OSHA may relent on hearing demands to change TB skin-testing frequency
CDC/NIOSH comments on proposed TB standard
Testimony from the federal Centers for Disease Control and Prevention may persuade the U.S. Occupational Safety and Health Administration to change its proposed requirement for six-month tuberculin skin testing (TST) of health care workers to annual screening in most cases, Hospital Employee Health has learned.
While OSHA officials at this point are saying only that they are considering modifying that provision - one of the most controversial in the proposed tuberculosis standard - testimony from the CDC and other commenters may be turning the tide toward less frequent TST.
"That's an issue we're hearing a lot about, and we may be open to making it more like what the CDC has recommended," says Amanda Edens, OSHA project officer for the TB standard. "There are a lot of data in the record to suggest that's possibly the way we're going to go."
OSHA's proposed standard presently calls for retesting every six months for HCWs with occupational exposure to TB.1 This provision and the proposed requirement for annual respirator fit testing are the two mandates that have drawn the most criticism from hospital occupational health practitioners. They claim the TST portion of the proposed rule lacks sound scientific support, is too broad, and would be practically impossible to implement given the limited resources with which many departments operate. (See Hospital Employee Health, January 1998, pp. 1-4; June 1998, pp. 69-72.)
Most practitioners favor the CDC's guidelines for preventing TB transmission in health care facilities, which call for annual retesting of employees in low-risk categories and retesting every six to 12 months for HCWs in intermediate-risk categories.2
OSHA currently is conducting public hearings on the proposed standard in several U.S. cities. In opening remarks at the recent Washington, DC, hearings, Linda Rosenstock, MD, MPH, director of the National Institute for Occupational Safety and Health, an arm of the CDC, notes that occupational TB transmission has decreased significantly in institutions "where CDC guidelines were vigorously implemented."
While advocating a mandatory standard to ensure that employers protect HCWs from unnecessary exposure risks, the CDC outlines several areas of concern about the OSHA proposal. In most cases where the proposed standard differs from CDC guidelines, the CDC argues for changes that support its own recommendations. For example, the CDC is asking OSHA to remove "the universal requirement" for six-month skin testing. "In some settings, that frequency may produce excessive numbers of false positive skin tests and unnecessary exposure of employees to preventive therapy," the CDC states,3 pointing to reports in the medical literature as evidence.4-6
Instead, the CDC maintains its 1994 guideline for annual skin testing is adequate for most HCWs, based on risk assessment, number of TB patients, and worker exposures.
"You would expect them to say that because obviously they support their own guidelines," says Edens, "and where there is a difference [between CDC recommendations and the OSHA proposal], I would assume that CDC would stand by their guidelines."
Nevertheless, OSHA officials consider the issue of possible false-positive TST results "a valid point," she says. "It's one of the areas where we have found very persuasive arguments. The concern is that in low-risk settings where they don't see much TB, and the likelihood of exposure is less than in some other settings where TB is more prevalent, you run the risk statistically of getting false positives."
Because the TST is neither very specific nor very sensitive, more frequent skin testing in low-prevalence settings produces a greater likelihood of false positives. Placing HCWs on preventive therapy with isoniazid puts them at risk of toxicity from a drug they might not have needed in the first place.
While six-month testing across the board "might not be a good idea," in some situations it may well be appropriate, says Edens, "such as where there is a high prevalence of TB or if you're doing high-hazard procedures."
TST frequency is really the only major difference between the CDC guidelines and the proposed standard in terms of exposure control plans, she maintains.
"If you look at what CDC recommends and what OSHA would require, many things are the same," she says. "The thing that changes as you go across the board is not necessarily the risk assessment but the frequency of skin-testing."
However, the CDC has asked OSHA to allow health care facilities to be able to choose between developing facilitywide exposure control plans and those that are specific to areas or locations within a facility. Providing a choice will allow program managers to target their efforts and more effectively identify and control hazards, the agency argues.
OSHA, CDC approaches similar?
CDC guidelines call for conducting risk assessments in areas or locations in which HCWs provide services to and share air with specific patient populations or work with clinical specimens that may contain viable M. tuberculosis organisms. For example, HCWs likely to enter an emergency department in a high-prevalence area may be at risk of TB exposure and would be included in the exposure control plan regardless of job category.
But OSHA counters that its proposal does essentially the same thing and incorporates the CDC approach to some extent.
"What we tried to do was structure it so not every employer will have to have a full-blown exposure control plan but could tailor it somewhat to the tasks being done in their facility. The kinds of questions you would ask in the [CDC's] kind of risk assessment to figure out what level of risk you have are the same kind of thought processes you would have in complying with the OSHA standard. It's not much different from the way you'd approach a bloodborne pathogens exposure control plan. You look at one area of the worksite to assess the risk of exposure and then put in controls that are appropriate for the kind of exposures you identify. That's how I envision the rule working," Edens explains.
The CDC guidelines' risk assessment schematic leads employers through an assessment similar to that proposed by OSHA, she says. For example, program managers would begin by assessing the prevalence of TB in the community. If there is none, a facility would fall into OSHA's minimal-risk category, which is similar to the CDC's minimal-risk category. If TB is present in the community, managers then would consider how their facility handles TB patients.
"If they see people with TB in the work setting but screen them out and send them somewhere else for diagnosis and high-hazard procedures, they basically fall into the same category as the CDC's very-low-risk category. If they treat TB patients, then they are in the low-, intermediate-, or high-risk categories," she says.
However, critics charge that OSHA's risk assessment lacks the scientific validity of the CDC's and that OSHA does not understand the rationale for a more flexible risk assessment system.
"The CDC's risk assessment is scientific, so as the science changes, it may change. But OSHA's is carved in concrete," says Eddie Hedrick, BS, MT(ASCP), CIC, manager of staff health and infection control at the University of Missouri Hospital and Clinics in Columbia.
OSHA's risk assessment is based more on the prevalence of TB in a community instead of within a facility, a system that will "cause confusion, unnecessary costs, and really isn't based on anything scientific," says Hedrick, who also is chairman of the TB task force for the Washington, DC-based Association for Professionals in Infection Control and Epidemiology (APIC).
Noting that the proposed standard states that OSHA rejected the CDC's risk assessment plan because it requires "a level of professional expertise in risk assessment that few entities outside large hospitals possess," Hedrick says OSHA was concerned its own inspectors would not have the expertise necessary to interpret the CDC's risk assessment system.
"That's silly. We teach people in home health and nursing homes how to use the assessment system. OSHA should pull together some experienced people to come up with a system of teaching their inspectors. That makes far more sense than developing a brand-new approach to this," he says. "My point is, if you can't teach them to interpret it, I don't want them coming to inspect my hospital."
Hedrick says the six-month skin-testing requirement in the proposed standard resulted from OSHA's rejection of the CDC's risk assessment plan. He is pleased that the requirement may be changed.
"That would be a good move. It didn't make sense to have to skin-test every six months. In middle America here, we find very few conversions skin-testing people annually, so at six months we wouldn't pick up any other real positives. We would be much more likely to pick up false positives. Skin tests are a very subjective, non-exact science. We find false positives quite frequently as it is," he says.
Both Hedrick and APIC maintain that a TB standard is unnecessary, but Hedrick says if a federal rule is inevitable, it should reflect the science contained in the CDC guidelines.
"My credibility in my institution is based on science," he states. "People trust me because they know whatever I implement is based on application of scientific principles. My doctors and nurses are very knowledgeable about tuberculosis. When I come in and tell them they have to do something that makes no sense at all, my credibility goes down the tubes. Therefore, my ability to sell them on these concepts goes away."
Professional HCWs cannot be "forced" to follow rules they find scientifically unsubstantiated, he adds.
"Threats of fines do not work to alter health care workers' behavior," he says. "It doesn't hit them in the pocketbook, and it doesn't hit employers in the pocketbook. It hits patients in the pocketbook. It's the guy in the bed who's going to pay for it. The best way to modify a professional's behavior is through data, through supporting information."
With only three confirmed TB cases a year in the entire state and rare cases of skin-test conversion among HCWs in his facility, Hedrick questions the wisdom of an OSHA standard containing provisions different from the CDC's recommendations. "I follow the CDC document to the letter, so why do I all of a sudden have to do all this extra stuff? I'm all for regulations when they make a difference, but this one will not benefit anyone."
Support for annual respirator fit testing
One other controversial provision of the proposed TB standard has full CDC support. While some commenters have argued that annual respirator fit testing is too time-consuming, costly, and scientifically unfounded (see Hospital Employee Health, February 1998, pp. 13-17), the CDC backs the requirement, which also is included in its own guidelines.
CDC testimony points out that both NIOSH7 and the American Industrial Hygiene Association8 recommend periodic fit testing, and that annual testing is the accepted professional standard endorsed by the American National Standards Institute.9 In addition, OSHA's recently issued respiratory protection standard requires annual respirator fit testing.10
At the same time, the CDC notes that "[w]hile there is little scientific proof that annual fit-testing is essential, we are unaware of any evidence that periodic, if not annual, fit-testing is not essential." The agency also says physicians and other licensed health care professionals cannot substitute judgment for periodic respirator fit testing, nor are there any evaluation criteria that can be used to guide a face-to-face assessment of the need for an annual fit test.
However, the CDC also suggests that OSHA might discover evidence in the course of the TB standard rulemaking that a face-to-face assessment would be reliable for "the narrowly focused purpose of protection against TB." If not, respiratory protection standard provisions should be used as a guide, the agency adds.
"The proper use of a respirator is as important as selecting the appropriate device," the CDC states. "The knowledge and ability to don and remove, check the fit and seals, and wear the respirator are among the skills that the trainees should demonstrate. Fit-testing provides an objective means for the trainer and trainee to evaluate the respirator skills of the user, including the ability to fit-check. We are unaware of any other procedure that provides a verification to both the trainer and trainee of adequate respirator fit and the skills essential to properly wear a respirator."
Edens also points out that the proposed standard provides "an out" for annual retesting. It requires an initial fit test but calls for annual repeat tests only when employees are not participating in their facility's medical surveillance program, or if significant changes have occurred in the employee's weight or facial structure.
"At the time of [an employee's] annual medical surveillance checkup, the licensed health care professional can look at him and say,'You haven't gained or lost a lot of weight; you haven't had dental surgery, and there hasn't been facial scarring, so you don't need to have another annual fit test.' We're allowing the licensed health care professional to make some on-site evaluations about facial structure," Edens says. "The other way they'd have to have an annual fit test is if the employee doesn't participate in the medical surveillance program. We only require that the employer offer it. If the employee doesn't want to do the medical surveillance, he doesn't have to. Some employers may make it a condition of employment, but OSHA can't do anything about that."
Meanwhile, OSHA is considering these and other comments from the affected community in formulating a final standard, still several years away.
"Their charge is much broader than ours," says Linda Martin, PhD, TB lead and director of HIV activity for NIOSH. "We try to look at it from what is scientifically valid, and OSHA tries to look at it from a feasibility standpoint, a cost standpoint, an impact standpoint, and a worker protection standpoint."
References
1. Department of Labor, U.S. Occupational Safety and Health Administration. Occupational exposure to tuberculosis; proposed rule. 62 Fed Reg 54,159-54,307 (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): 1-132.
3. Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Testimony of the National Institute for Occupational Safety and Health on the Occupational Safety and Health Administration proposed rule on occupational exposure to tuberculosis. 29 CFR Part 1910, Docket No. H-371. Washington, DC; April 1998.
4. Kopanoff DE, Snider DE Jr., Caras GJ. Isoniazid-related hepatitis: A U.S. Public Health Service cooperative surveillance study. Am Rev Respir Dis 1978; 117:991-1,001.
5. Snider DE Jr. The tuberculin skin test. Am Rev Respir Dis 1982; 125:108-118.
6. Snider DE Jr., Caras GJ. Isoniazid-associated hepatitis deaths: A review of available information. Am Rev Respir Dis 1992; 145:494-497.
7. National Institute for Occupational Safety and Health. Respirator Decision Logic. DHHS (NIOSH) Pub. No. 87-108. Cincinnati: NIOSH; 1987.
8. American Industrial Hygiene Association. Respiratory protection: A manual and guideline. 2nd ed. Fairfax, VA: AIHA; 1993.
9. American National Standards Institute. American National Standard for Respiratory Protection. ANSI Z88.2-1992. New York City: ANSI; 1992.
10. Department of Labor, Occupational Safety and Health Administration. Respiratory protection; final rule. 63 Fed Reg 1,152-1,300 (Jan. 8, 1998).
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