R. Bruce Williams, MD
August 2019—I am always interested in learning what is new in CAP laboratory improvement. My first inspection was some 40 years ago and our work in that realm has grown faster and gone further than I could have imagined back then.
The CAP accredited its first laboratory in 1964 and published the first checklist several years later. I’m told that when Dennis B. Dorsey, MD (a then-future CAP president), submitted the first draft at 10 pages, his fellow LAP commissioners asked that he try to make it shorter. Today our 21 checklists contain approximately 3,000 requirements. The science grows ever more complex, but we do our best to be concise.
CAP laboratory accreditation promotes excellence in laboratory practice. Our member volunteers steer the program as inspectors and team leaders, training new colleagues in making every inspection an educational experience for all involved. They also serve on committees whose work fosters excellence in practice and enables discernment, both during the inspection and when the data are crunched and the reports are written.
The CAP proficiency testing program is overseen by 600-plus physicians and doctoral scientists who serve on the 32 discipline-specific scientific committees that report to the Council on Scientific Affairs. The CSA committees produce PT products and do the highly complex work associated with accreditation by acting as resources for technical inquiries related to inspections, validate results, and envision next steps for the checklists. Our fine staff keeps the boat afloat, seeing that we keep pace with information technology and maintaining relationships with regulatory agencies and physician groups in related specialties.
While each CAP laboratory quality improvement tool bolsters the effectiveness and efficiency of CAP laboratory accreditation, it’s likely that none is better known than our proficiency testing program, CAP Surveys. More than 22,000 laboratories worldwide choose CAP proficiency testing. In 2018, we offered 650 Surveys, including 28 new programs (seven of which targeted next-generation sequencing). We have 18 new Surveys for 2019 and one of those (glucose, insulin, and C-peptide) is matrix effect free (or accuracy based). That gives us a menu of 10 matrix-effect–free programs.
Proficiency testing is integral to CAP laboratory quality assurance. While the Clinical Laboratory Improvement Amendments of 1988 require that laboratories report PT results for just 83 analytes plus microbiology subspecialties, laboratories that choose CAP accreditation prefer a higher level of scrutiny. CAP experts have identified more than 300 additional analytes whose clinical utility and medical relevance are critical to patient care and safety, and laboratories that choose the CAP submit results for those analytes as well.
Accreditation is multifaceted; PT is only one aspect. The CAP Checklists Committee, for example, writes, reviews, edits, and expands requirements on 21 discipline-specific checklists, which laboratory teams use to set performance goals and inspection teams employ to evaluate their success. Pathologist volunteers contribute deep, practice-based knowledge in routine and esoteric disciplines, such as molecular pathology, next-generation sequencing, and cytogenetics. They know that an accurate report is essential to patient safety and that busy laboratory teams much prefer a prescriptive checklist, one that tells them exactly what they need to do and how they can best show that they are fully compliant with CLIA requirements.
Ideally, each inspection team mirrors the expertise and composition of the laboratories they inspect. In 2018, there were more than 8,000 CAP-accredited laboratories, 489 outside the United States. Nearly 2,200 volunteer pathologists served as on-site inspectors. We inspected more than 4,300 laboratories that year, including 236 that specialize in reproductive, forensic drug testing, and biorepository specimens. A total of 335 laboratories (69 of them international) earned CAP accreditation for the first time in 2018.
Although biorepositories are not CLIA regulated, the 2019 checklists will reflect our decision to make CAP-accredited biobanks more consistent with CLIA. For example, we will be moving from a three-year to a two-year accreditation cycle for that reason. Although biorepository accreditation is voluntary, the CAP Biorepository Accreditation Program is raising the bar because we recognize that all biobanks should be working toward the optimal performance that researchers need and our patients should expect.
The relatively new CAP 15189 Accreditation Program is catching on as word spreads about how its problem-solving approach can boost innovation, teamwork, and efficiency. ISO 15189 is a quality management standard commonly used outside the U.S. that complements our way of thinking and maybe even completes it. One might say that ISO 15189 is more about process and CAP accreditation is more about technical skill and procedure, or that ISO 15189 is an umbrella approach, looking at the entire testing experience end to end from an altitude of 30,000 feet. For example, root cause analysis, an ISO 15189 quality tool, encourages teamwork between management and front-line personnel, empowering everyone to contribute to collective problem solving. When we combine the rigor and precision of the Laboratory Accreditation Program with the scope and depth that drives the process-oriented approach of ISO 15189, we’re moving in the right direction. They work well together, the combination is forward looking, and CAP 15189 makes ISO 15189 accreditation more accessible.
I’d also like to call your attention to the CAP Test Ordering Program, which provides tools to guide discussions with clinician colleagues about test selection. This complimentary member-only resource is organized in modules and includes physician education materials for clinician partners. The newest modules concern biomarkers in colorectal cancer (BRAF), celiac disease testing, free prostate-specific antigen testing, and urine myoglobin. They can be downloaded at www.cap.org. More modules are in the pipeline; they’re a great bridge-building tool.
Finally, I hope many of you will check out the 2018 CAP Annual Report (https://capatholo.gy/2yljvuv) for a closer look at what we’ve been up to. We accomplish a great deal when we put our heads together. Please forward the annual report to any colleagues who do (or do not) see the value of joining us.
Dr. Williams welcomes communication from CAP members. Write to him at president@cap.org.