Interviews

An interview with CAP about their new ISO certification program for laboratories

With special thanks to the College of American Pathologists

On March 3rd, 2008, the College of American Pathologists officially introduced ISO certification for laboratories to the United States.

“This new program accredits laboratories to conform with International Organization of Standardization (ISO) 15189:2007, and will be available to interested medical laboratories in the United States during the fourth quarter of 2008. This accreditation will be separate and distinct from the CAP Laboratory Accreditation Program (LAP), however, laboratories accredited to the ISO 15189:2007 standard will be well-positioned to rapidly respond to the changing health care environment and demonstrate measurable quality to their customers.”

This announcement should not come as a surprise. CAP was heavily involved in the development of the ISO 15189:2007 standard. On the whole, regulations in the US and guidelines from CLSI have been gradually adopting ISO terminology and concepts for years. CAP’s announcement merely confirms the trend.

Eager to hear about ISO's future here in the US, Westgard QC interviewed several members of the CAP ISO program, including, Dr. Cordelia Sever, head of the CAP ISO Program and Accreditation Committee, and Caroline Mauer, the CAP ISO program manger.

Well, not quite yet

CAP’s announcement does not mean they are open for business immediately. As the press release notes, they project that labs will be able to apply for audits at the end of 2008. Right now, they are actually in a pilot phase, which means they are guiding several labs through the process of certification.

CAP expects to finish pilot tests and allow laboratories to apply to certification by the end of the year. In the meantime, they are collecting the contact details of laboratories that are interested in certification.

What is ISO 15189:2007 again?

ISO 15189:2007 is a specific standard for medical laboratories (the first number indicates the identification number set for the standard; the second number indicates the year when this version was issued). For years, laboratories seeking ISO certification had to apply the ISO 17025 standard, which is actually intended for large chemical laboratories. With ISO 15189, a standard specifically tailored to the context of the medical laboratory is available.

ISO, the International Organization for Standardization, is a multinational non-governmental group that develops and publishes standards (more than 17,000 standards have been published, as of the end of 2007). While ISO standards are not mandatory – since they do not carry the weight of law – the fact that they are accepted around the world as best practices means that certification is often a key advantage for an organization.

Dr. Sever explains, “ISO is an internationally recognized standard. They have been worked on very long. They are based on quality principles that go all the way back to Deming…. It's an evidence-based standard.”

What’s the difference between CLIA and ISO 15189?

The simplest difference is that while CLIA and state regulations (as well as Joint Commission, CAP, COLA accreditation guidelines) are domestically generated here at home, ISO 15189 is a global standard. It was created by committees made up of experts, researchers, and industry representatives from all over.

In addition to a difference in origin, there is a difference in scope. “In the current [CLIA] accreditation standards,” Dr.Sever explains, “the focus is very much on actual testing operations. It's on a very low level of quality systems management, whereas the ISO standards have incorporated a large volume of upper management standards. So the biggest difference is a more focused auditing of management standards."

Finally, there is a difference in mandate. In the US, it is your legal requirement to comply with CLIA. Certification to the ISO 15189 standard is your choice. But keep in mind that ISO 15189 certification will not exempt you from CLIA. You always have to comply with CLIA – there’s no getting around that.

What’s the benefit of ISO 15189?

Dr. Cordelia Sever cautions that it’s probably too early to put numbers and hard specifics to the benefits of ISO certification. “It very much depends on where laboratories are in the process. The gains will be more if you are at a very low level of sophistication; your quality improvement will be much higher. The other component of the value is the value perceived by the customer. Since there is no widespread existing accreditation, this component of customer perception will only become apparent as the program is up and running."

Overall, Dr. Sever hopes that ISO 15189 “will elevate quality standards. It will be beneficial for laboratories that have to deal with global business.”

Who audits? Who trains? Who can help?

Often, an organization that seeks ISO certification will hire a consultant who will help guide them through the process. A legion of businesses exist to help companies get through ISO 9000 certification and many of those companies will adapt their expertise to help laboratories, although a few healthcare and laboratory-specific companies do exist.

But a consultant is not a mandatory part of the certification process. It may be convenient for a laboratory to hire outside help, but it isn’t required. Caroline Mauer, the CAP ISO program manager, says in the pilot sties, "one of our labs has had a consultant to assist them. [Other labs] have felt that they can do this without taking on a full time consultant to help them through the process.”

As an accreditator, CAP is not allowed to provide consulting services for certification. They will offer help in performing the Gap analysis and pre-assesessment, if requested. CAP’s ISO inspectors will be fulltime CAP employees that are specifically trained in ISO auditing. As an organization involved in the development of the ISO 15189:2007 standard, they feel they bring special expertise as an accreditor.

Why choose ISO?

Although CAP possibly won’t agree with our characterization, we believe ISO may offer the opportunity to raise the bar on quality in a time of lowering standards and deteriorating practices. While CLIA may be slowly degrading the quality control practices in the laboratory, ISO has the potential to advance the practice of laboratory medicine.

2008 has seen the arrival to two new options for the laboratory: the full legalization of CLIA EQC practices, and the introduction of ISO 15189 standards.

Dr. Sever believes that CLIA is not as bad as some people (that would be us) say. But she does hope that ISO 15189 “will drive another round of general quality improvement."