CLIA inspectors offer insider tips for a smoother recovery. This is the continuation of a story based on interviews with three Clinical Laboratory Improvement Amendments surveyors. To see their first two tips on how to prepare for surveys, see last week's MLR.
Not only would a room of one's own give the surveyor a place to delve into QA records, but it would also help minimize any potential interference with the lab's day-to-day operations, they maintain. "We try not to be disruptive, because we know [the laboratorians] have to carry on their duties of the day just as if we were not there," says Theresa Irwin, the CLIA program director for the Mississippi State Department of Health in Jackson, MS. However, with lab legroom at a premium, not every facility can afford to set aside space for its inspectors, and indeed, all three surveyors can describe instances of perching on a stool, working on the edge of a counter, or simply surveying "with just a clipboard and no desk." When it's time to examine a lab's documentation, Irwin likes to make some notes on her own and then follow up by asking laboratory personnel any questions she might have. This, she says, is much more preferable to having someone "standing over my shoulder, looking at everything I do, because sometimes that makes the process a little bit more uncomfortable for us because we can't concentrate as much." While it's nice for surveyors to be able to have some solitude with lab records, it's also important that surveyors have access to laboratory personnel when necessary. Though lab directors aren't required to be present at all times during a survey, "it's very helpful if the director is at least available in case I have questions," says Nancy Hines, a surveyor with the Rhode Island Department of Health's CLIA Laboratory Program in Providence, RI. "I'm not sure how other people work, but I don't send surprises in the mail," she states, meaning she endeavors to explain potential deficiencies before citing them. This gives the laboratory an opportunity to clear up any misunderstandings about impressions the surveyor has formed. "For example, is there an order, final report and tech ID for each test performed? Is quality control for that test within the acceptable range?" asks Hines. While surveyors generally inspect a random selection of QA documents, Irwin explains that with larger hospital labs, she'll often request to see records from the holiday periods. Since these facilities can often be shorthanded during the holiday season, Irwin will seek out such records "just to make sure that [the labs] are still keeping up the consistency of what they're doing in times when a lot of people drop the ball." Otherwise, she suggests clinical labs review at least some documentation for each and every type of test they perform. A surveyor who spots troubling trends in documentation or procedures is likely to wonder why the lab didn't detect such trends itself, says Hines.