Small or big, even after 10 years one of the most common questions the committee gets about the CAP 15189 program is: Where’s the checklist?
“Most people are used to the Laboratory Accreditation Program, which is very checklist based,” he explains. “But the ISO program doesn’t have a checklist. It’s based on this international standard 15189. The first advice I always give people is, go online and buy yourself the standard. There is no checklist; it’s a collection of requirements that a laboratory should meet. The goal of ISO is not to develop or publish accreditation documents. They publish standards, and it is up to you how you want to meet the requirements. So it is not prescriptive, like certain CLSI documents that tell you exactly how to do things.”
The other common question he hears: Why would we do this? One answer he often gives: “We have learned over the years that many laboratories benefit from it in terms of constant inspection readiness and deficiency reduction. When you look at the outcomes of LAP inspections, a lot of problems laboratories have are document control, and ISO labs perform pretty well in those inspections.”
In the end, what drives people into the program, in his view, is the vision of “not stomping out fires when they run into problems”—that is, “not struggling anymore with these recurrent issues.”
Juan C. Millan, MD, whose laboratory system recently achieved 15189 accreditation, agrees. “The important thing is that you have to look at everything that really is not coming out right. You cannot just simply say, ‘Well, it’s a random error.’ You need to look and do root cause analysis where you see what is required, and then you change the processes.” Dr. Millan is clinical vice president of diagnostics, director of chemistry services, and medical director of Legacy Laboratory Services, Portland, Ore.
Dr. Schneider elaborates: “ISO is a wonderful complement to a very technical driven Laboratory Accreditation Program in that it provides this overarching process-oriented look at the laboratory from beginning to the end. It’s designed in a way that it improves the operation of the whole laboratory. For that, you need the right culture in the laboratory. I think laboratories do better if they want it. I recommend that labs don’t look at this as something that they have to do, and it usually doesn’t work as well if it gets handed down from the top as, ‘Someone should do this.’”
“What laboratories should know is that this is easier than you think,” he concludes. “And there’s no reason to shy away from it.”
Anne Ford is a writer in Evanston, Ill.
Laboratories interested in ISO 15189 accreditation, or those that are already ISO 15189 accredited but wish to exchange information with peers, can request a tour of Henry Ford Health System laboratories, which are an ISO 15189 Center of Excellence and Learning. To request a tour, contact Caroline Maurer, director of CAP 15189 Laboratory Improvement Programs, at firstname.lastname@example.org or 847-832-7451.