Proposed lab guidelines may carry high price
Could spell doom for small labs, say critics
Proposed new guidelines for laboratories that handle Mycobacterium tuberculosis have many TB controllers fretting about expensive renovations and uncomfortable respirators. Even more worrisome to some is the prospect of watching their TB specimens disappear into the black hole of a reference lab in a far away state.
Margaret Tipple, MD, medical officer for the Office of Health and Safety at the federal Centers for Disease Control and Prevention (CDC) and co-author of the proposed guidelines, replies that she is not unsympathetic to such concerns, and promises to weigh reactions to the proposals with care. In a recent interview with TB Monitor, Tipple even made an offer to readers to extend the comment period, despite the fact that it ended officially July 28.
All the same, she says, laboratorians and clinicians need to understand the urgency she feels. Highly resistant strains of TB pose a threat to lab workers’ health, and the fact that labs have come under increased pressure to work faster and more accurately makes accidents more likely to happen, she says.
"We all have this feeling that we ought to be doing something," says Tipple. "We don’t have enough data to know exactly how much to worry. But we do know one thing for sure: The stakes are much higher than they used to be."
Tipple is in the midst of collating reactions received so far. "There’s lots of comments on respirators, double doors, and monolithic floors and ceilings," she says. Smaller hospitals, which critics charge will be among those hurt most by the new guideline, haven’t weighed in as much as other institutions, Tipple notes, adding, "If there are people out there who’d still like to send comments, we’d be pleased to receive them."
Trying to create a consensus document’
Her intent isn’t to impose unwanted restrictions on labs but to create "a consensus document," she says. "We put this document out for comment because we truly felt we urgently needed more input from the scientific community and the user community before we publish." If there’s actually less risk than she thinks there is, she adds, "we need to know about that, too — we don’t want to formulate regulations that are overly stringent or overly costly."The cause of all the uproar is the CDC’s forthcoming update of the Agent Summary Statement for M. tuberculosis, which is set forth in the so-called "gray book," Biosafety in Microbiological and Biomedical Laboratories, or BMBL (U.S. Department of Health and Human Services, 1993). Published in the Federal Register for comment last spring,1 the portion that pertains specifically to TB labs is titled, "Goals for Working Safely With Mycobacterium, Tuberculosis in Clinical, Public Health, and Research Laboratories."
The document incorporates the first significant revisions in the BMBL pertaining to labs that handle TB specimens since 1981. The new guidelines, due out in fall of 1998, are expected to recommend that labs that handle M. tuberculosis upgrade their facilities and personnel practices from biosafety level 2 (BL-2), to the more stringent and elaborate demands of biosafety level 3 (BL-3).
If that happens, laboratorians would be required to don respirators and other protective gear — gowns, booties, etc. In addition, labs would have to beef up their facilities by adding physical barriers, including anterooms with double doors, directional airflow, and "monolithic" (i.e., airtight) floors and ceilings to permit thorough decontamination in the event of a big spill.
The rationale for all the changes is compelling, says Jonathan Richmond, MD, PhD, director of the Office of Health and Safety at the CDC and Tipple’s co-author for the new guidelines. Laboratorians who handle TB specimens are estimated to be three to five times more likely to contract the disease than other lab workers, Richmond told a meeting of the CDC’s Advisory Council for the Elimination of Tuberculosis (ACET) held in Atlanta last April. They also are 100 times more likely to be infected with TB than the general population, Richmond continued; and they perform up to a dozen different procedures that can generate aerosols.
Out of 49 state and territorial public health labs that responded to a survey, 13 labs reported incidents of conversions between 1990 and 1994, with seven of 21 employees affected documented to have been infected on the job, Richmond reported.
8% to 30% of TB labs suffer conversions
Such cases may represent only the tip of the iceberg, say Richmond and Tipple. Most instances of nosocomial infection and skin-test conversion in TB labs cannot be readily documented, and thus, are never published. (Indeed, one authority cited in the introduction to the proposed guidelines estimates that between 8% and 30% of labs may experience conversions.)2Critics disagree, saying that the current system is not broken and doesn’t need fixing — but that adding a new layer of bureaucratic guidelines may break it.
Typical of such protests are complaints voiced by the 43,000-member American Society for Microbiology (ASM), in a recent letter to the CDC. The risk assessment for lab workers is inflated, partly because it is based on old data from other countries, the ASM says. Plus, by recommending inappropriate or uncomfortable garb or equipment, the proposed changes would actually create new problems.
Most TB controllers feel the same way, say Nancy Dunlap, MD, PhD, chief medical adviser to the Alabama TB control program, and John Bernardo, MD, TB controller of Boston. "The adverse consequences of these guidelines will be great and will wreak havoc with many TB control programs," says Dunlap.
In Alabama, the state laboratory processes "huge volumes" of specimens without incident, Dunlap says. "They’ve cultured over 85,000 specimens within the past 10 years and had only two conversions, both when the hood of a worker’s safety cabinet malfunctioned," she says. At the University of Alabama lab, which processes about 1,000 specimens a year, there have never been any skin-test conversions, she adds.
In Boston, Bernardo tells a similar story. Boston Medical Center’s lab handles 3,000-plus specimens a year, he says, and there have been no conversions among the staff for the past five years. "It’s a BL-2 lab, but the equipment is well maintained, and the people are well-trained and very aware," says Bernardo.
The prospect of having to put lab personnel into respirators makes Bernardo especially nervous. In a BL-3 area in the hospital’s research lab in Boston, "it’s very uncomfortable being in respirators and gowns for just 30 minutes, let alone an entire shift," Bernardo says. "It’s going to be hard to find good-quality people willing to work under those conditions."
Shutting down for lengthy decontamination
Tipple says she is aware of the downside of respirators and won’t recommend them lightly. "Respirators and their users both need a fair amount of coddling, and the respirators must be worn appropriately," she says. "They can be real uncomfortable. We don’t want to make people so aggravated that we cause more trouble."Having to install monolithic floors and ceilings is what worries Ann Vannier, MD, director of microbiology at the regional reference laboratory for Kaiser Permanente’s Southern California Region in North Hollywood, CA. "We have such a high volume of specimens, I don’t want to take the chance of dropping a culture and being exposed, so we already wear respirators," she says.
But she dislikes the idea of having to shut down the lab for a lengthy decontamination in the event of a spill, Vannier says. "That’s a sticky wicket. If you use paraformaldehyde, you kill all the cultures in that room; plus, you wind up with people not able to work for a long time period."
Perhaps the touchiest issue in the proposed guidelines is the cost to smaller labs of renovations to install the double doors and the monolithic floors and ceilings.
"The CDC claims that the extra expense isn’t a big deal, but spending $50,000 is a big deal, especially in this day of managed care," says Dunlap. Renovations in the lab at the University of Alabama have been estimated to cost about that much, she says, and Alabama’s state lab will probably have to cough up an extra $100,000.
"We’ll do it, because we’re the biggest labs around, and we have to," she says. "But the small labs in the state aren’t about to. So all our surveillance is going to fall apart."
Bernardo is equally unhappy at the thought of losing his small labs. "It’s occurred to me that maybe the hidden agenda here is to shut down small labs and send all the business to reference labs," he says. "That would be all right if there were some provisions for a new infrastructure to support the changes. But there aren’t."
If small labs quit handling TB, specimens will have to be shipped out to big, out-of-state reference labs. The result will be slower turnaround times, and more instances of patients getting separated from their specimens, Dunlap and Bernardo predict.
Labs in New Jersey don’t care about Alabama
"Sure, the report eventually gets back to the hospital, but it gets shunted off to the record room or winds up at the bottom of a stack of papers on a physician’s desk," Bernardo says. "I know because there are instances where that’s exactly what’s happened."The 15% of specimens that Alabama sends off to a reference lab are what cause most of the state’s lab-related problems, says Dunlap. "Most of our reference labs are in New Jersey; they don’t care about us," she says. "We don’t get timely reporting, and by the time results do come back, the patient’s already gone. That means we have to identify that patient and then go out and do a contact investigation months after the fact."
Part of the problem with out-of-state reference labs is the way reporting procedures vary so much from one state to the next, Bernardo says. Plus, the more labs handle a sample, the more likely the sample will be misidentified somewhere along the line, he says. Sending specimens out of state also increases the chances for contamination, says Dunlap. "We’re finding that the more TB cultures you have in one spot, the greater the possibility for contamination," she says. "That means someone’s culture in New Jersey may have contaminated one of our cultures, and we’re treating someone unnecessarily."
Also, there’s something illogical in requiring only TB labs to upgrade to BL-3, says Bernardo.
"What about specimens not known to contain TB?" he asks. The new guidelines "don’t take into account the hundreds of samples that aren’t labeled TB, but nonetheless are teeming with it," he says. "Pathology specimens, autopsy specimens . . . even stuff from the regular bacteriology labs: Do you put all these workers into BL-3 as well?"
More to complaints than meets the eye?
Tipple says she’s heard most of these arguments but wonders if there’s more to them than meets the eye. "I’m very sympathetic to the needs of small hospitals," she says, adding that she grew up in a rural area. "There’s a question of pride in providing good services to doctors in the community. Plus, it’s a real pain in the neck to courier specimens to other labs."At the same time, she says she’s skeptical about the clamor over the high costs of renovations.
"That may really be a marker for concern over [other] costly renovations," she says. Perhaps some small labs are already having a tough time keeping abreast of new technologies, maintaining quality assurance, and keeping staff well trained, she says. Does it make sense for them to keep processing TB specimens? "I’d like to know whether people are being honest when they complain about four walls and double doors," she says, "or whether that’s just one more thing in a complex mix of economic factors."
In fact, most TB labs are already in good compliance with gray book standards, says Richmond. But the resurgence of TB has generated a higher volume of specimens, coupled with an increased demand for speed and accuracy, he says. That, in turn, raises the risk of exposure for lab workers. In addition, more lab workers are immunocompromised now, he adds.
"It would be great if you just had one person in his or her own small lab, and you didn’t have to worry about anyone else," says Tipple. "But the danger is that you run into someone, or you drop something and it breaks." (In that case, counters Dunlap, why doesn’t the CDC do what people really want and provide better ways to train workers and monitor equipment?)
The decision to write new guidelines turns as much on intuition as fact, Tipple admits. "TB in the laboratory is an area where we have a lot of experience, but not a lot of systematically acquired data," she says. "While we can make empiric recommendations, we don’t know exactly what the risk factors are in the lab. We don’t know whether wearing respirators will protect you, or whether we should be more concerned about equipment maintenance, or if we should worry about procedures we use for handling contaminated material."
Certainly, anecdotal reports give cause for concern, she says. "Everyone I know who has been in the field for awhile knows about someone who’s had a skin test conversion," she says. "You can go to a lab and talk to 50 clinicians or lab workers, and everyone will tell you about conversions."
[To send comments, address them to Vickie Rathel, Office of Safety and Health (OSH), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd. NE, MS-F05, Atlanta, GA 30333. Comments may be faxed to Vickie Rathel at 404/639-3394, or submitted by e-mail to [email protected] as WordPerfect 5.0, 5.1, 5.2, 6.0, 6.1; or ASCII files.]
References
1. 62 Fed Reg 23,068 (1997).
2. 62 Fed Reg 23,067 (1997).
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