Health experts stage 11th hour protest against upcoming OSHA TB standard
Existing guidelines work without expensive regulations
First it was managed care, then the threats of the prospective payment system, but now the regulatory monster rearing its ugly head is the new tuberculosis (TB) guidelines.
Despite declining TB rates and frustration over "absurd" mandates, such as respirator fit testing and costly engineering controls, TB practitioners and nursing home executives are arguing that the proposed federal TB standard could prove to be an unnecessary and expensive regulation for an already hard-pressed health care industry.
At press time, the Occupational Safety and Health Administration (OSHA) was expected to publish the long-awaited standard as a proposed rule in the Federal Register in August 1997. 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 scheduled around the country.
Foreshadowing the debate in the upcoming hearing and comment process on the controversial regulation, the Washington, DC-based 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." (For information on other groups’ opinions on the guidelines, see the related story, p. 99.)
Is new standard an unnecessary expense?
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 (CDC) 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."
Though conceding that infection control staff 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, and chairman of the APIC TB committee. Hedrick 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 notes.
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.
Lee Reichman, MD, MPH, director of the National TB Center in Newark, NJ, agrees, pointing to a recent CDC study of a nosocomial TB outbreak in which a transmission occurred despite an existing fit-testing program. "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. These people have religious reasons for wearing a beard. So the whole thing is absurd, but this is nothing new."
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."
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 exposures 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
Risks vary at each facility
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 testing 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. However, the data are confounded by the fact that there is a high prevalence of TB in the community.
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 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."
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."
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.