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Inside the Lab Quality assurance and quality control, Laboratory management

The Value of Extended Availability

sponsored by Technopath

If you could improve one thing about your laboratory technical operations, what would it be? As someone with decades of clinical laboratory experience, I’ve found analytical quality control (QC) to place some of the highest demands on laboratory professionals engaged in the unrelenting effort to keep analytical error rates low.

QC materials are one of the most important tools used by the 24 clinical laboratories in our healthcare network to harmonize test results. Because different lots of QC materials have different analyte concentrations, we use the same lots throughout the network – so you can imagine the complexity of coordinating simultaneous transitions.

A QC lot changeover constitutes a significant operational and quality disruption. You need to test the new lot of materials for about two weeks, analyze the results extensively, evaluate stability, and account for the differences among instruments performing the same tests to ultimately roll out new performance targets. Even after you have placed the new lot in operation, you must remain especially vigilant for weeks or months to ensure that the statistical performance holds up. Because laboratory expertise is in critically low supply and these lot-to-lot transitions are managed by our best-qualified staff, each changeover involves not only direct material and labor costs, but also huge opportunity costs by distracting senior laboratory professionals from other pressing tasks.

In a large laboratory, you might be doing this a dozen times a year, each time requiring several weeks of work and a small army of people.

In a large laboratory, you might be doing this a dozen times a year, each time requiring several weeks of work and a small army of people. In a network of laboratories like ours, these efforts are amplified exponentially because they take place simultaneously in every lab and require synchronization of hundreds of operational and information technology changes across the network. QC lot transitions are even more disruptive when not predicted.

That’s why we sought out ways of increasing predictability and reducing lot-to-lot transitions. A first step was to reduce the number of different QC materials: we replaced six chemistry QC materials with two Technopath controls. That change alone cut the number of expected lot-to-lot transitions in three years for the dozens of tests covered by these materials from 10 to zero – but that was not all. The new controls also last longer, not just because of their longer shelf life and the decrease (by about 50 percent) in amount needed, but also because of more reliable availability. Previously, we were often unable to use our controls up to the labeled expiration date because suppliers ran out of inventory prematurely or analytes began to degrade. So far, we have exceeded the longest stability period of the previous materials (two years) with no evidence of degradation.

Many discussions focus on the theory of analytical QC, but it is often the practices – the day-to-day reality I experience in our own labs and see in visits to others – that determine how effective our analytical QC systems really are. How many procedures and record-keeping steps are needed? What do technologists do when the QC is out? How does the lab manage corrective actions? Is QC used to prevent, in addition to detect, test inaccuracy? How disruptive and labor-intensive are lot changeovers? Those things make a big difference, and lot-to-lot changes can throw this system out of balance because they represent periods of heightened risk for errors and uncertainty. For instance, if you switch lots and find yourself out of control, you need to consider an expanded range of possible interpretations: Is it the instrument? A reagent? A test calibration issue? Or unexpected behavior of the new lot?

When you devote your laboratory staff time to changing lots and then compound potential error sources, you’re removing them from other patient testing needs. Just last week, I had an important clinical question for the manager of our coagulation laboratory – but I couldn’t reach her because she was preparing for a QC lot changeover. I had to make a patient with a possible bleeding tendency wait while the laboratory completed the QC task. Nothing focuses us on the need for efficient QC operation like being unable to immediately address urgent patient needs!

The most impactful costs are the pervasive effects on downstream healthcare expenses and compromised patient outcomes.

QC is a tool of quality maintenance. Its goal is to reduce or eliminate analytical errors in lab test results. There’s often a tendency to forget that quality is free and that the costs of its tools are dwarfed by the cost of potential errors due to poor quality. As physicians, we swore to do no harm – an oath we break if a wrong healthcare decision follows an inaccurate test result. The potential liability risks of these errors might also be significant; the monetary cost of a single such mistake could match or exceed the cost of a lab technician’s salary for a decade. But the most impactful costs are the pervasive effects on downstream healthcare expenses and compromised patient outcomes.

That’s why our laboratories switched to new QC materials. Fewer controls require fewer changeovers, and the longer they remain stable, the more we can reduce disruptions. We have been using the same lots of Technopath chemistry QC materials for over two years with no issues; our current target is three years before changeover. We can measure that gain in dollars or in hours of time saved, but there’s an even more important metric: positive patient health outcomes.

And it’s because we recognize this value that, following a thorough evaluation of our QC materials, Northwell Health has partnered with Technopath to help make their products available throughout the US.

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About the Author
Samuel Reichberg, MD, PhD, FCAP

Associate Medical Director of the Northwell Health Laboratories and Professor of Pathology and Laboratory Medicine at the Zucker School of Medicine at Hofstra University in New York, USA.

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