Health experts stage 11th hour protest against upcoming OSHA TB standard
Health experts stage 11th hour protest against upcoming OSHA TB standard
Existing guidelines work without expensive regulations
Amid declining tuberculosis rates and frustration over "absurd" mandates, such as respirator fit testing and costly engineering controls, TB practitioners and infection control professionals are arguing that the impending federal TB standard could prove to be an unnecessary and expensive regulation for the hard-pressed health care industry.
The Occupational Safety and Health Administration (OSHA) is expected to publish the long-awaited standard as a proposed rule in the Federal Register in late July or August. The standards, designed to protect health care workers from occupational TB infections, will be open for comment for a period of 60 to 120 days. Hearings are expected to be held around the country.
Foreshadowing the debate in the upcoming hearing and comment process on the controversial regulation, the Association for Professionals in Infection Control and Epidemiology (APIC) recently testified before Congress that the OSHA standard and subsequent inspection and enforcement process is "a needless waste of taxpayer dollars."
Noting that TB is in decline in the United States and comprehensive infection control guidelines were issued by the Centers for Disease Control and Prevention in 1994, APIC argued that the OSHA standard will be redundant and expensive. The remarks came in testimony before the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies.
"There is no need for a completely separate OSHA regulatory structure to address this very same issue," says APIC member Julie Sellers, RN, BSN, CIC. "APIC believes that the CDC is far more knowledgeable than OSHA to handle TB prevention and control for both health care workers and consumers. Furthermore, 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. An OSHA regulatory standard would not."
The National TB Controllers Association in Atlanta has not come out with a position on the new guidelines. However, director Walter Page notes that CDC officials have argued in the past that its guidelines are sufficient for controlling TB if they are followed.
"CDC has taken the position a number of times saying, Look, if you just follow the guidelines, none of these new stringent recommendations are needed.’ They have demonstrated from experiences in Miami and Chicago after they had outbreaks that once they followed the guidelines, they were able to turn things around."
Lee Reichman, MD, MPH, former president of the American Lung Association and director of the National TB Center in Newark, NJ, agrees with the APIC stance that the proposed standard is overkill. "What is well-documented is that when after the rates went up and people started to use the then prevalent guideline, not the new stuff, then transmission was very hard to document," he tells TB Monitor. "High index of suspicion, isolation of infectious cases, treating them right away with those kind of things it was very difficult to document transmission."
Although the center’s chest clinic has experienced only three conversions over the years, the state will be requiring that it spend nearly $500,000 on engineering controls, even though the center plans to vacate the building in several years. "I would think that the money could be better used for services or control," Reichman says.
Though conceding that those involved in infection control may be fighting a losing battle, the need for the standard will continue to be challenged as the debate sparked by the proposed rule ensues, adds Eddie Hedrick, MT (ASCP), CIC, chairman of the APIC TB committee. He concedes that the health care community may be fighting a losing battle. However, the debate over the need for the standard will increase during the comment period.
"TB is at its lowest level since we first started monitoring it in this country in 1953," says Hedrick. "The problems that occurred from 1989 to 1992 were brought under control with the implementation of basic infection control practices and a better understanding of TB and the immune-suppressed HIV-positive patient. The things that are clearly most important are early diagnosis and treatment."
Concerns about testing, respirator programs
Having reviewed some earlier drafts of the standard as part of the "stakeholder" process where interested parties were allowed to give OSHA feedback, Hedrick says concerns remain about the frequency of OSHA-required skin testing. Whereas CDC guidelines allow flexibility based on risk assessment of workers, one draft of the standard required twice-annual testing for all employees who may have potential contact with a TB patient, he says. Over-testing of workers could lead to some false-positive converters being inappropriately placed on drug therapy with isoniazid, Hedrick says. Another major point of contention is the expected OSHA requirement for a comprehensive respirator fit-testing program for health care workers treating TB patients. Rather than implementing such labor-intensive testing programs, Hedrick argues that workers should be taught to routinely "fit-check" their respirator to ensure it is sealing properly on the face and filtering inhaled air.
Reichman agrees, pointing to a recent CDC study of a nosocomial TB outbreak in which a transmission occurred despite a fit-testing program in place. "We are required now by the state to do fit-testing. We have a whole bunch of bearded house staff, and they want them to shave their beards. There are some people who have religious reasons for wearing a beard. So the whole thing is absurd, but this is nothing new. OSHA treats TB hospitals like mines, and hospitals aren’t mines."
Ultimately, OSHA’s traditional focus on engineering controls for identified risks (i.e, known TB cases) will do little to prevent transmission from the greatest threat to health care workers the undiagnosed case, Hedrick laments. "So the implementation of all of these things will make little to no difference," he says. "However, it is like trying to stop a freight train when you try to stop OSHA."
An OSHA TB standard may not have been so strongly challenged a few years ago when TB was resurging in the United States but now seems to be addressing a problem that has dramatically improved, adds Michael Tapper, chairman of the AIDS/TB committee of the Society for Healthcare Epidemiology of America.
"This [OSHA standard] may just be the wheels of government turning slowly, but we are putting out a potentially very expensive solution to a problem which, fortunately, seems to be improving, " he tells TB Monitor. "That doesn’t mean that we should be [complacent] about transmission of TB in health care settings, but it does seem that, at a time when medical resources are being severely pressed in a whole variety of areas, this is going to create a new administrative burden."
How great that burden will be remains unclear. The draft standard has already passed muster with the Office of Management and Budget but has reportedly been revised from earlier versions to minimize the impact on small businesses and other facilities with limited resources such as homeless shelters.
Risk and confounding variables
Though TB cases declined for the fourth consecutive year in 1996, OSHA still contends the standard is needed to protect health care workers and other employees from occupational exposure to TB. In general, CDC investigations and data from ongoing surveillance systems suggest TB risk is higher for certain health care occupations and procedures, but implementation of infection control recommendations has proven effective in halting outbreaks and preventing transmission to workers.1 According to the CDC, the magnitude of risk to health care workers varies considerably by the type of health care facility, the prevalence of TB in the community, and the worker’s occupational group. Even when skin test conversions are documented in workers, it remains difficult in many cases to delineate between community-acquired and nosocomial transmission cases, particularly since some of the highest rates in health care workers occur in areas with a high prevalence of TB in the community, officials report.
For example, an ongoing CDC TB skin test-ing surveillance project found a 1.1% skin test conversion rate for health care workers at sentinel sites across the nation but a conversion rate of 4.2% for health care workers in New York City. Workers at greatest risk for skin test conversions in New York were nurses and "outreach workers" who administer directly observed TB drug therapy to outpatients. However, the data are confounded by the fact that there is a high prevalence of TB in the community, and many of the workers are foreign-born.
"Foreign born individuals are more likely to be convert [skin tests]," says Yvette Davis, MD, medical epidemiologist in the division of TB elimination. "We know that they convert, but we don’t know whether they [are infected] in their occupations or their communities."
The data are comparable to that gleaned from other CDC surveillance systems, including the number of people with active TB who listed their professions as health care workers. In 1995 the most recent year for which the data are available of 22,860 total cases reported, 79.6% had occupation information reported. Of those, 64.5% were unemployed, and 2.8% were health care workers.
"I don’t really consider health care workers a high risk group in the sense that you would consider other risk groups," says Patti Simone, MD, medical epidemiologist in the CDC TB elimination branch.
"There is a potential for risk if there are no [infection control] measures in place, but also most health care workers aren’t exposed to TB patients. In certain communities and certain hospitals there is a lot more risk than others."
While OSHA is expected to incorporate much of the CDC guidelines into its proposed standard, some of the flexibility may be lost at the local level as the document is standardized to make it enforceable by OSHA inspectors.
"They have to make it enforceable," Simone says."Our idea was to make it flexible so that people could design an infection control program that made sense for them."
But reg could boost compliance, funding
On the other hand, the OSHA TB standard could have positive effects in terms of bringing lax programs into line and requiring more thorough documentation of infection control efforts, says William Jarvis, MD, chief of the investigations and prevention branch in the CDC hospital infections program. CDC surveys have found improving implementation of the TB guidelines since they were issued three years ago, but appropriate skin testing and documentation of testing programs is lacking at some facilities, he says.
"The thing that we are finding very frustrating is when we ask about health care worker skin testing data, that is actually the hardest data to get," he says. "I think there still are a lot of facilities out there that are not testing the appropriate employees.
Reference
1. Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care facilities, 1994. MMWR 1994; 43:1-133.
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