The Importance of CAP 15189 Accreditation in Laboratory Operations and Healthcare (Full Transcript)

Speaker 1: CAP 15189 Accreditation is definitely a badge of industrial rigor. It does take effort for our research institute, for any of the large IVD manufacturers to know that we're CAP 15189 accredited. It gives us an approach that's rigorous, it's standardized, and they know that if we can pull that off, we can do these research studies with them.

Speaker 2: We have, obviously, our internal clients who are physicians who are taking care of people. They come from all over the world to the number one respiratory and immunology hospital in the world. Our other group of clients are our reference laboratory partners. A lot of business with very large commercial laboratory entities that are sending us esoteric kind of testing. And the third set of clients is pharma and biotech. So on our day-to-day structure, whatever systems we have in play, they have to work essentially for all three of those in parallel.

Speaker 3: Our biggest thing is change control and how do we make sure changes that come in place that all the stakeholders are engaged. We know what all the impacts are within our laboratory, but we also know the impacts outside of our laboratory. So our IST requirements, our facilities requirements, how do we engage everybody to have it be the most successful process?

Speaker 1: Laboratories, unfortunately, operate a lot in the background. Nobody thinks of ISO accreditation when they turn the light switch on, the lights come on. The laboratory is basically relegated to operate all day, every day, seamlessly. We touch so much of the healthcare system that if there's a problem, it just rattles through the entire health system. And you can bring a health system to its knees with problems in the laboratory. Having ISO accreditation basically means they don't have to worry about that. We've got the policies and procedures and the kind of rigorous oversight that the laboratory is not going to be a problem for them. CAP 15189 also forced us to standardize every single analyte, every single result, so they're all reported the same way. A lot of what the laboratory is doing now is looking for ways to improve patient care and population health by using aggregate data. And the only way you can do that is with standardized data.

Speaker 2: We have the need now to deploy laboratory tests into accountable care organizational contexts that presume ever-improving performance. We're all interested in turnaround time, and obviously it is turnaround time at the level of just get it out as fast as you can. In ISO 15189, CAP 15189, what you're looking at is how the information is deployed and whether or not the end user is actually finding utility in that data point. That's a huge difference from just, okay, I got to get this test out as fast as possible. That is a fundamental difference. And so when we tackle the turnaround time issue, it is not just how fast can you get the data out, it is where is the data going and how is it being used. That is the pay for performance function.

Speaker 1: For our commercial laboratory operation, again, talking with CEOs and CFOs and COOs of large health systems, to be able to say we're ISO accredited is definitely a foot in the door for those institutions.