OSHA indicates it will pull back on some TB standards
Possible testing frequency, two-step requirements
Confronted by a united front of professional health care organizations, the Occupational and Safety and Health Administration (OSHA) has signaled it will back down on several requirements of its proposed TB standards. Despite criticism that the standards are too late and based on gross overestimations, the agency nonetheless is committed to creating them once public hearings are completed.
Last April, in the first of four public hearings on the proposed rule, OSHA heard input from dozens of stakeholders, ranging from the Centers for Disease Control and Prevention (CDC) in Atlanta to individual hospitals where TB is a major problem. Even before the public hearing in Washington, DC, OSHA officials were considering revisions in light of comments it has received since it published its proposed standard in the Federal Register last year.
"We have already begun to see that some of the provisions may need to be modified in response to certain persuasive arguments contained in comments and testimony," says Adam Finkel, PhD, OSHA's director of health standards programs. "OSHA acknowledges that there are some situations where OSHA and CDC differ in regard to frequency of skin testing and baseline two-step skin testing. OSHA will fully consider these concerns."
Other areas in which OSHA is considering modifications include:
o UV lights: TB experts have argued OSHA's proposal that UV lights can't be used as a primary engineering control for isolation rooms and areas of high-hazard procedures will discourage their use in other areas, such as intake rooms. OSHA will seek ways to identify situations where UV may provide protection when ventilation engineering controls are not feasible.
o Signage: OSHA's requirement of identifying isolation rooms with warning signs that are universally understood could compromise patient confidentiality. OSHA is open to other options.
During the hearing, Finkel addressed some of the concerns that have been expressed to OSHA and said many of those had been based on misconceptions. (For details of his explanation, see p. 79.) In general, OSHA remains committed to the principles it set for developing the standard and, despite a 20% decline in TB rates for the past seven years, those principles remain relevant today, he said.
Not everyone agrees on the need for OSHA's standards, according to testimony from the Association for Professionals in Infection Control and Epidemiology (APIC). "According to the CDC, the incidence of TB in the United States has dropped to the lowest level ever recorded, due to the cooperative efforts of our medical and public health communities. Clearly the TB 'crisis' that OSHA is attempting to address has passed," APIC stated.
But Finkel didn't buy that argument. "Even if there is no risk whatsoever of a resurgence, we still believe that the magnitude of the problem requires more attention," he said at the hearing. "One might remark that the 16% TB decline over the past three years is much less pronounced than the 35% decline in AIDS cases over the same period - and the latter is rarely dismissed as a `solved' problem."
Tuberculosis morbidity findings from the CDC showed that new cases of TB dropped from 21,337 in 1996 to 19,855 in 1997. While the number of cases decreased in the six states that make up more than half of all TB cases (Califor nia, Florida, Illinois, New Jersey, New York, and Texas), nearly 40% of TB cases were reported in 64 major cities. (For the rates of change, see chart, p. 77.)
Although unsolved, the TB epidemic of the late 1980s has been significantly reduced and was highly concentrated, said Edward Nardell, MD, chief of pulmonary medicine at Cambridge (MA) Hospital and spokesman for the American Thoracic Society's (ATS) position.
"Following a very careful review of the proposed standard, it is our belief that it mandates far too much intervention and comes far too late in the view of the magnitude of the current tuberculosis risk for potentially exposed workers in the United States," he said.
Indeed, the risk for workers who are covered doesn't meet OSHA's threshold for a standard, he noted. "The CDC guidelines were an appropriate response at the time they were formulated, but the proposed OSHA standard will be far out of proportion to the risk by the time it is implemented, and increasingly inappropriate and burdensome with each passing year if current epidemiologic trends continue," he added.
Nardell presented results of a 1996 CDC study showing health care workers had TB rates "similar to the general population. Elevated rates were found only for inhalation therapists and low-paid health care workers," he said, adding that the higher rate among lower-paid workers suggests a higher likelihood of community-acquired than occupational-acquired TB.
Referring to the American Lung Association's belief that the TB risk for workers has decreased greatly since the CDC's 1994 guidelines, Nardell said the ATS funded a meeting of experts to re-evaluate the risks to workers and other institutional occupants, as well as to calculate cost analyses of various control measures such as isolation of suspected TB patients.
ATS is concerned that OSHA requirements will lead to costly over-isolation of suspected patients. At Grady Hospital in Atlanta, for example, triage and isolation have led to isolating seven non-TB patients for each one who has TB, he noted. The problem is likely greater in low-incidence areas, he added.
Noting that CDC guidelines have not been implemented by many facilities, particularly for providing adequate isolation and baseline testing, Finkel said, "We are not inclined to believe that our standard will come `too late' in the fight against TB. Rather, we believe it will come at just the right time to ensure that the substantial progress being made in some portions of the health sector is mimicked by the majority of areas and sectors that have yet to take the requisite steps."
The CDC recommended OSHA drop a proposed requirement for tuberculosis skin testing of health care workers every six months and allow some local flexibility in developing exposure control plans.
The CDC generally supports OSHA's proposed TB standard, but essentially it made suggestions that would bring the rule more in line with its own TB guidelines.
"We are suggesting that facilities should be able to choose between developing facilitywide or area- or location-specific exposure control plans," the CDC said. "Providing this choice will allow program managers to target their efforts, allowing for more efficient and potentially more effective identification and control of hazards.
The agency also recommended OSHA remove the six-month TB skin test requirement because, in some settings, that frequency of testing may produce excessive numbers of false-positive test results. The remaining skin testing provisions would provide sufficient worker protection.
Testing provisions vary
While OSHA would require six-month testing for all workers who enter a TB isolation room, the CDC guidelines allow for TB testing to be based on risk assessments that may vary the testing provisions within different areas of the institution.
"Facilities that elect to do an area-specific exposure plan may identify areas of the facility where the risk of exposure is greater than the rest of the facility and where six-month testing may be appropriate," CDC testimony stated.
Making six-month testing an option would not leave workers unprotected because other provisions of the standard call for testing "at least" annually, after exposure incidents or whenever a worker has signs or symptoms, the CDC noted.
Acknowledging the legitimate concerns over increasing false-positive results, Finkel said OSHA will seek information identifying when six-month testing may be inappropriate or beneficial. Like wise, the agency will address concerns that two-step testing is not necessary for all new employees and will gather data to help define what subpopulations should not be subjected unnecessarily to additional skin testing, he added.
Labor unions want more coverage, not less
Echoing OSHA's contention that CDC guidelines are not fully or rigorously implemented, the American Federation of State, County and Municipal Employees (AFSCME) requested that OSHA broaden the scope of its standard to include coverage of workers in these situations:
o Long-term care institutions other than those serving the elderly. AFSCME is particularly concerned about TB transmission in homes that serve the mentally ill, in rehabilitation centers, and in AIDS care units. "Residents of these facilities usually have one or more of the recognized risk factors for TB," said Jordan Barab, assistant director of safety and health.
o Social work, social welfare services, teaching, law enforcement, and legal services. Those groups also service high-risk persons.
"The real risk to social workers and others in this category is that they have contact with persons who are not known to be infected," Barab emphasized, adding that criteria for coverage should not be contact with someone identified with TB but contact with people in high-risk groups.
In addition, AFSCME is asking OSHA to develop procedures for TB outbreaks in offices, factories, and other low-risk workplaces where outbreaks may occur.