First came the anthrax scare in June at the Centers for Disease Control and Prevention. A few weeks later, several vials of "old" smallpox were discovered in a storage room at the National Institutes of Health. And there was a cross-contamination incident in May in CDC's influenza lab that CDC's director says he wasn't informed of until July 9.
If nothing else, the recent stream of news seems to indicate that when it comes to safety, it all boils down to guarding against human errors in judgment—even at the most secure federal labs.
So what do these recent high-profile cases mean for hospital labs, which must handle human blood and bodily fluids and other bio-hazards on a daily basis? While it isn't an apples-to-apples comparison, since hospitals don't handle anthrax and smallpox within their labs, will this trio of egregious incidents prompt hospital administrators to reconsider their own safety policies and procedures?
"It never hurts for hospital administrators to have a conversation with their lab directors," to ensure that proper policies are in place and to ask about anything that seems to be of concern, said Susan Helms, a laboratory clinical specialist for Premier, Inc., a healthcare improvement company. Said Helms, it's never a bad idea to discuss lab safety and to ask whether any gaps need to be filled or whether there are opportunities to make changes in the process.
High-profile lab safety cases might even encourage hospitals to "look at whether they need new ways to handle specimens and 'live bugs' in-house," Helms told Healthcare Dive.
Building a 'culture of laboratory safety'
CDC also sees broader implications from federal labs' recent lapses. "We think there are lessons here for other laboratories," CDC Director Tom Frieden said during a July 11 press briefing at which he highlighted steps being taken to improve lab safety and prevent further incidents.
Frieden said the trio of events at CDC and NIH "should never have happened," and are are serving as a wake-up call. He said he has placed a moratorium on the transfer, inside or outside CDC, of infectious agents. Frieden said CDC's director of lab safety will serve as his point man, and that he will take disciplinary action against any workers who didn't follow protocols or properly report incidents.
CDC's influenza lab is now closed and won't reopen until proper procedures are put in place, he said. CDC doesn't think anyone was exposed to anthrax from the other lab incident, he said, and the agency continues to examine smallpox vials from NIH. He said he learned July 10 that two of six vials showed evidence of growth; and, after the remaining four vials are tested, all specimens will be destroyed.
During a Q&A session with reporters, Frieden stressed the need for a "culture of laboratory safety," putting strong systems into place to combat human errors in labs. To illustrate the point, he said that prior to his work at CDC, he had looked into lab contamination among New York hospitals in the early 1990s and found that 3% of New York City patients had false-positive cultures for tuberculosis due to lab errors. (During the 1980s, New York City had experienced a rapid increase of TB cases, more than 40% of which were associated with HIV, Frieden's study noted.)
The industry has made significant progress in the past two decades in the way hospital labs check for TB, Premier's Helms said. Now, she said, most work is done with bottled, not live, organisms; lab procedures to prevent cross-contamination are improved, and it doesn't take six weeks to get results.
No need to fall into 'panic mode'
Hospital administrators "don't need to fall into panic mode" over lab safety concerns, Helms stressed, because medical directors must review lab policies routinely and there are "extremely stringent" layers of regulations governing patient and worker safety in hospital labs.
"As a general rule, our hospitals are diligent in following requirements" for lab safety, said Helms, who works with Premier's hospital members in the southeastern U.S. on laboratory needs. Premier runs a national alliance of about 3,000 hospitals and 110,000 other providers seeking to transform healthcare.
Indeed, Helms said she feels confident that U.S. hospitals have strong systems for lab safety in place. Currently, most safety concerns revolve around worker, and not patient, safety, she said, since labs are following strict guidelines and risks are generally low.
According to Helms, the Premier alliance's monthly education calls with its member hospitals have focused more on bringing new technologies into the lab than on safety concerns. "I can't even tell you the last time I had a safety question" from a hospital, she said. "It's just so well-covered. Across the country, folks are doing a good job of managing that."
The chair of Mayo Clinic's bio-safety committee was unavailable at press-time. But Robert Nellis, a Mayo Clinic spokesman, said that "safety in laboratories and with materials has always been a priority here and is part of our overall emphasis on quality."