CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Laboratory peer group reporting
Peer group reporting, often in real time, is one option for laboratories seeking to keep close tabs on their QC. “Peer group reporting is a huge time saver,” says Margaret Fick, RIQAS scientist with Randox Laboratories in Northern Ireland, U.K.
Fick
“When you’re working in a laboratory, the biggest problem is having confidence in your results, and you don’t have many places to look for confidence,” Fick says. “Looking at peer group reports and seeing that you’re behaving the same as everybody using the same reagents or instruments, wherever you are, lets you know you’re achieving as true a result as possible.”
Through its Acusera 24.7 program, an interlaboratory data-management package that can be a useful tool in helping to fulfill risk-assessment requirements outlined in the CMS’ IQCP guidelines, Randox allows laboratories to monitor the progress of their QC programs. Acusera 24.7 helps identify stability of assays over time to set the appropriate frequency of QC and distinguishes acceptable from unacceptable results using multi-rule functionality.
Dosseh
Producing graphs in the laboratory to monitor QC is difficult without the software to do it, but with the software the laboratory results are interfaced from the instruments straight into the 24.7 program without human intervention, Fick says. “The point of monitoring is to watch how your QC results are moving about the mean and to be aware of any changes, to be able to take corrective action before your QC actually goes out of control.” Without such a program, “you end up taking action only when your QC is already out of control, and then you have to start repeating and retesting patients.”
Traditionally, Streck’s feedback indicates core laboratories do adhere to the CLIA minimum by performing two levels of external controls on each system each day of testing, says Maria J. Dosseh, MLS(ASCP), technical services manager at Streck in Omaha. Streck was one of the earliest developers of hematology control materials for automated instruments. “I feel IQCP will make labs re-evaluate and ask if that frequency is sufficient.”
As of yet, Streck has not received many requests from its customers for help or guidance on IQCP, Dosseh says. “Part of the reason is that CMS has said you can’t take a manufacturer’s checklist and sign off on it and incorporate it as your own. But many of the checklist items are already pieces the lab should have considered, such as: What factors or conditions create risk of harm in pre- and postanalytical processes, and what are you doing to minimize that? Does it make sense to apply the two standard deviation formula? Or should you use more evidence-based QC, or even establish QC frequency based on the performance level you wish to achieve in your laboratory?”
Assessing as much data as possible is one way to improve QC, she notes. “We’re working with very sophisticated instrumentation. However, it’s subject to error and that’s what we tell customers when they call and say, ‘I ran controls this morning and in the afternoon this happened.’ That’s why you’re doing additional checks throughout the day—not just when it’s convenient to perform QC—because there could be a bubble in the reagent or a crimp in the tubing, or an issue with pressure.”
It’s becoming more and more the norm that QC results are entered electronically, Dosseh says. Using its customers’ QC data, Streck provides a complimentary report monthly called STATS that gives customers a peer-to-peer comparison of their lab and others using the same instrument or method and the same control material. “The lab gets a synopsis of their statistical information and then a historical data section that provides their 2 SD calculation. So if that’s what they want to implement as a starting point for their ranges, they have all that information on one page.”
Customized QC plans for each test are the key, Dosseh says. “Whether or not you choose to incorporate more complicated statistics in your QC metrics, the most important piece for each lab is to adjust for their unique environment and their patient population. So if a manufacturer gives you a reference range for a test, and maybe you have a patient population that is more geriatric, can you use that range and call results ‘normal’?” Using evidence-based QC will allow labs to incorporate more flexibility to be compliant and still provide quality patient testing, she says.
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Anne Paxton is a writer in Seattle.
