TB Update: Is OSHA Standard Needed?
OSHA’s TB standard called expensive and unnecessary
But more IC program support may result
With tuberculous in national decline and control measures in place at many facilities, an impending federal TB standard could prove to be an unnecessary and expensive regulation for the hard-pressed health care industry, infection control professionals warn.
Yet as this issue of Hospital Infection Control went to press, the long-awaited TB standard by the Occupational Safety and Health Administration (OSHA) was expected to be published as a proposed rule in the Federal Register in late July or August, says OSHA spokeswoman Susan Fleming in Washington, DC. Designed to protect health care workers from occupational TB infections, the standard will be open for comment for a period of 60 to 120 days, she says.
"Then we would hold hearings and they might well [take place] around the country," she says.
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 "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.
APIC cites need for flexibility
"There is no need for a completely separate OSHA regulatory structure to address this very same issue," testified 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 continuously 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 ICPs 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, BS, MT (ASCP), CIC, chairman of the APIC TB committee.
"TB is at its lowest level since we first started monitoring it in this country in 1953," Hedrick tells Hospital Infection Control. "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."
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 had twice-annual testing required for all employees who may have potential contact with a TB patient, he says. Overtesting of workers could lead to some false-positive converters being inappropriately placed on drug therapy with isoniazid, Hedrick notes.
Undiagnosed cases remain a threat
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. Ultimately, OSHA’s traditional focus on engineering controls for identified risks (i.e., known TB cases) will do little to address 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 the proposed standard now seems to be addressing a problem that has dramatically improved, adds Michael Tapper, MD, chairman of the AIDS/TB committee of the Society for Healthcare Epidemiology of America (SHEA).
"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 HIC. "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 already has passed muster with the Office of Management and Budget, but has reportedly been revised from earlier versions to minimize impact on small business and other facilities with limited resources, such as homeless shelters.
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 tuberculosis. 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 because some of the highest rates in health care workers occur in areas with high prevalence of TB in the community, officials report.
Foreign-born people confound data
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 to outpatients. However, the data are confounded by the fact that there is high prevalence of TB in the community and many of the workers are foreign-born.
"Foreign-born individuals are more likely to 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 profession as health care workers. In 1995 (the most recent year for which these 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 in others."
In that regard, the CDC guidelines call for each facility to conduct a TB risk assessment and implement infection control measures such as frequency of TB skin testing based on the prevalence of TB in the patient population. The guidelines emphasize rapid identification, isolation, and treatment of TB cases, but also allow minimal program requirements for facilities that see few TB patients. (See Hospital Infection Control, December 1994, pp. 161-166.)
"In my opinion, we do not need this [OSHA] standard because the incidence has gone down in the country and we have very little TB in our organization," says Gloria Bonnicksen, RN, CIC, director of infection control at HealthSystem Minnesota in Minneapolis. "The CDC should be the governmental body that gives us guidance in how to manage infectious diseases. The CDC guidelines for tuberculosis are practical, flexible, and based on science."
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."
Standard 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 investigation 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 which are not testing the appropriate employees. Often attending physicians are not included but hospital administrators are, which makes no sense. Many [ICPs] are having a very difficult time managing and organizing their databases, which I think is important if you are going to follow up health care workers. If the OSHA rule helps facilitate that and gives infection control departments the support they need in order to accomplish that, then it certainly would be worthwhile."
Indeed, a recent survey of ICPs conducted by the CDC and APIC found that only 27% disagreed with a statement that "the proposed OSHA TB standard will improve the quality of employee health and safety in my facility." Even though APIC has officially come out against the standard, 44% of the ICPs polled agreed that the TB standard would improve their programs and another 29% were neutral. Though the OSHA bloodborne pathogen standard was the subject of controversy and debate when it was issued in 1991, 90% of the ICPs polled agreed that the standard has improved quality and safety. Many ICPs may feel they need the OSHA TB standard to pressure health care administrators to appropriately budget TB infection control measures, Jarvis suggests.
"We hear commonly that the infection control department doesn’t have a great deal of administrative support for their activities even though they have more and more activities thrown at them as their responsibility," he says. "It may be useful to have a regulatory agency out there saying you have to do this, as they did with bloodborne pathogens. Because there is no doubt that hospital administrators do pay attention to that."
Indeed, an ICP with several concerns about the OSHA standard concurred that such is often the case in many health care settings.
"As we get deeper into managed care, some folks just don’t want to spend the money," says Patti Grant, RN, BSN, MS, CIC, infection control coordinator at Parkland Health and Hospital System in Dallas. "As soon as the government says you have to, then you have to. As embarrassing as that is to admit as a health care worker, that is a reality that I know many people share. That is probably the largest single benefit to anything OSHA does, but it creates a lot of nightmares in the process."
Concerning the latter, Grant wonders whether hospitals may be held accountable by OSHA inspectors for TB exposures to patients with atypical TB that may go undiagnosed initially, or for health care worker infections that may have occurred in the community. The upcoming comment and hearing process will be a critical period for ICPs to make their points known and fight for needed revisions, because final OSHA standards carry the weight of inspections and fines to enforce compliance, she adds.
"ICPs aren’t going to have any choice then but to give it the same credence as they did the bloodborne pathogen [standard]," she says. "There are financial ramifications of non-compliance. Period. End of story. Whether it’s right or wrong then will really be irrelevant."
Reference
1. 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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