Point of Care testing standardization: key steps and benefits

Contributing lab leaders: Alison Woodworth, PhD

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. Not mentioning all the other potential benefits it can bring, including economic benefits, improve patient management, faster access, reduced length wait times, and reduce time spent waiting for rapid test results.

What many health systems fail to realize, however, is that standardization is rarely straightforward. 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.

Article highlights:
  • Most organizations choose to standardize point-of-care (POC) testing for three reasons: to meet state and federal regulations, to improve patient safety, and to improve diagnostic capabilities.
  • The steps to successful standardization for the typical health system include identifying clinics that are running POC testing, ensuring all entities are in compliance with regulations, choosing the appropriate testing platform, and staff education.
  • Standardization must be a collaborative project involving all stakeholders in point-of-care testing, from the laboratory director to the clinical staff.

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At the start: know your reasons for standardizing Point of Care testing 

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."

A "multi-layered process"

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 the University of Kentucky," 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 verify implementation of 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. “Once we had that, we started looking at these different platforms to see which ones we wanted to standardize among everyone 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 applicable regulations and the corresponding medical specialty."

The issue of supply chain management was by far the biggest challenge her team faced, as it guided the University of Kentucky 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 for diagnostic tests must be stored and tested in certain ways before they are put into use, for example. “You have to be very careful about how you handle them—so the supply chain needs to understand that and know what is required of them."

It takes a team

Most important to standardizing POC testing and ensuring that an organization reaps the benefits, Dr. Woodworth says, is a continual collaboration among all of those involved. In the University of Kentucky'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, that facility's end-users, and “support all the way up to the top, with involvement from our chief administrative 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 project—not something you just do overnight." At the University of Kentucky, they succeeded through hard work. “You really do have to get everyone involved, and you have to be ready to just figure things out."

POC benefits

POC testing can bring a plethora of benefits to your organization, especially when testing is standardized effectively. These benefits include but are not limited to reduced stress on laboratory testing, faster access to rapid test results, improved efficiency in emergency departments, and ultimately staff that is more empowered to make clinical decisions. On top of the ways that Dr. Woodworth highlighted in this article, there are also many other ways to optimize your ways of working to reap the benefits of POC testing. In order to work out how to improve POC testing within your organization, you should be looking to conduct a systematic review of your current ways of working, along with a cost-effectiveness analysis. Completing both of these with help to ensure your organization can spend less time worrying and more time reaping the benefits that standardized and improved POC testing can provide.

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