Transforming laboratory quality through proactive risk management

My name is Bill Donohue. I’m the founder, president and CEO of CarePoint Solutions.

Since the Institute of Medicine published To Err Is Human and Crossing the Quality Chasm, we’ve learned a number of things about clinical laboratories and their practices. Rather than finding only five or ten major points of failure within a test system, we have discovered that diagnostic errors often amount to ‘death by a thousand cuts’. It is therefore incumbent on laboratories to review their entire testing process.

We know that pre-analytical errors contribute to most diagnostic errors, so it is important to conduct a comprehensive risk assessment. However, this has not been happening. Even in 2016, when CMS introduced risk management under CLIA for the first time, implementation was largely unsuccessful. What we learned is that laboratories need the right tools.

It is one thing to set a new standard for diagnostic accuracy, but we also need to equip laboratories with the tools, resources, processes, and data they require, including inter-laboratory comparisons, which they are not currently receiving. Risk management has transformed virtually every other industry, yet it is noticeably absent at the leading edge of healthcare delivery.

With the strong focus on risk mitigation in the 2022 update to ISO 15189, we believe this is a historic and unprecedented opportunity to address diagnostic error at scale for the first time, and we do not want to waste it.

Pro-QCP™ is a first-of-its-kind quality management utility. It guides a laboratory step by step through a comprehensive risk assessment, identifying all known sources of error in its unique testing process and highlighting opportunities to mitigate those errors.

It is essentially a gap audit: we compare what a laboratory is currently doing with what we consider best practice. We integrate accreditation requirements and good laboratory practices, while also incorporating manufacturers’ recommendations and requirements, so that all the bases are covered.

Ultimately, we show laboratories where opportunities for improvement lie and implement a continuous quality improvement process. We are moving them away from a one-size-fits-all, paper-based, static quality management process towards a dynamic, data-driven and outcomes-oriented approach that continuously improves.

There are two things I’m particularly excited about right now. First, because this is a digital solution, we can take it to the front line of healthcare delivery, where it can do the most good. That is especially exciting for resource-challenged countries and laboratories operating with very limited resources, which describes many laboratories worldwide amid current staffing shortages.

The second point is best illustrated by an example. I was speaking with a physician microbiologist at Baylor University Healthcare while demonstrating Pro-QCP. He paused, laughed and said, “Bill, you’re making me wonder what I do for a job.”

I wasn’t sure what he meant, but he explained: “I oversee 83 laboratories and I’m responsible for regulatory compliance. I’m a firefighter. Inspectors come in, identify deficiencies, and then I rush to the rescue. I handle the corrective action plan, get the laboratories out of trouble, and that is my job.

“But with your program, once we network all the laboratories within my healthcare system, you’ll give me unique visibility into both the quality performance and regulatory compliance of every laboratory under management. Because it is a self-audit tool, the laboratories will do the heavy lifting, and all that information will feed into my remote dashboard.

“I’ll be able not only to monitor their progress remotely, but also to be proactive. Instead of inspectors finding my outliers, I can identify them first.”

That was really exciting to me. Our product does not simply turn the lights on for the laboratory; it delivers actionable information across the entire healthcare system.

Why is risk management important in clinical laboratories?

Diagnostic errors can arise at multiple points across the testing process, particularly during the pre-analytical phase. A comprehensive risk-management approach helps laboratories identify potential sources of error, strengthen controls, and improve the reliability of patient results.

What is Pro-QCP?

Pro-QCP™ is a digital quality-management utility from CarePoint Solutions. It guides laboratories step by step through a risk assessment tailored to their testing processes and environment, helping them identify risks, review existing controls and prioritize opportunities for improvement.

How does Pro-QCP support ISO 15189:2022 requirements?

ISO 15189:2022 places greater emphasis on risk-based quality management and continuous improvement. Pro-QCP supports this approach by helping laboratories perform comprehensive risk assessments, document risk-mitigation measures and maintain an inspection-ready quality process.

How is a dynamic quality-management process different from a paper-based system?

A paper-based system can become static and may not reflect changing risks or performance. A dynamic, data-driven process enables laboratories to review outcomes, identify gaps and update their controls as part of continuous quality improvement.

Can Pro-QCP help organizations manage multiple laboratories?

Yes. By networking laboratories within a healthcare system, Pro-QCP can give leaders greater visibility into quality performance and regulatory compliance. Remote oversight can help them identify outliers early, monitor progress and act before deficiencies are found during an inspection.

Who could benefit from Pro-QCP?

Pro-QCP is designed for clinical laboratories and point-of-care testing locations seeking to improve diagnostic accuracy, simplify risk assessment, strengthen regulatory readiness and standardize quality-management practices across testing platforms or sites.