When healthcare organizations choose to standardize point-of-care (POC) testing, they typically do so for three specific reasons: to improve patient safety, to meet state and federal regulations, and to bolster their diagnostic capabilities with testing methodologies that match their needs. What many health systems fail to realize, however, is that standardization is rarely a straightforward process. With its logistical requirements and wide range of stakeholders, standardizing POC testing has been likened by some to the taming of the Wild West. Organizations can certainly standardize successfully, but they'd better understand the steps that are required and be prepared to face challenges along the way.
With that in mind, here's some advice from one laboratory leader who has successfully navigated the road to standardization: Alison Woodworth, PhD, Director of the Core Clinical Laboratory, Clinical Chemistry, and Point of Care Testing at the University of Kentucky College of Medicine in Lexington.
Because standardization can be difficult, it's important to understand how it will help your organization, Dr. Woodworth says. In the University of Kentucky's case, they decided to standardize primarily to ensure they were in compliance with the Centers for Medicare and Medicaid Services' (CMS) Clinical Laboratory Improvement Amendments (CLIA) regulations. Beyond that, Dr. Woodworth notes, “We wanted to adopt a platform that would make testing both safer and easier across our outpatient settings. And we also knew that standardizing could give us leverage when we ordered reagents and supplies, and in that way could potentially save us a lot of money."
Dr. Woodworth describes standardization as a “multi-layered process" that includes everything from identifying the end-users who are running POC testing to staff education and supply chain management. “The first thing we did at UK," she says, “was determine which of our clinics were actually using POC testing. Then we asked each of them to provide documentation of their CLIA licensure, as well as show us that they'd implemented the required quality-control programs." They also asked clinics to present them with evidence they'd conducted test-method validation on each of the platforms they were using. “And then once we had that, we started looking at these different platforms to see which ones we wanted to standardize everybody to before we rolled them out one at a time." As they did so, Dr. Woodworth notes, they also spent significant time training the appropriate staff. “They not only needed to know how to use the platform, they also needed to understand the specific regulations that applied to them and their medical specialty."
The issue of supply chain management was by far the biggest challenge her team faced as it guided UK through the standardization process, Dr. Woodworth says. “The intricacies of working with POC testing supplies are very different than working with boxes of gloves or tubes." Reagents must be stored and tested certain ways before they are put into use, for example. “You have to be very careful about how you handle them—so supply chain needs to understand that and know what is required of them."
Most important to the POC testing standardization process, Dr. Woodworth says, is continual collaboration among all of those involved. In UK's case, she explains, that included—in addition to herself—the laboratory medical director, the ambulatory POC supervisor, and two employees who were hired specifically to do ambulatory POC testing. It also included the POC coordinator at the system's hospital, as well as that facility's end-users; and it included “support all the way up to the top, with involvement from our chief administration officer and chief medical officer." And finally, Dr. Woodworth notes, successful standardization at her organization ultimately hinged on the participation and cooperation of individual clinic managers and their clinical staff. “You have to remember, this is a huge process—not something you just do overnight." At UK, they succeeded through hard work. “You really do have to get everyone involved, and you have to be ready to just figure things out."
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