President’s Desk

March 2006
Reinforcing the safety net

Thomas M. Sodeman, MD

Continuous quality improvement is a cornerstone of the CAP Laboratory Accreditation Program (LAP); change is a constant. But we are in the midst of a bona fide growth spurt right now. In coming months, as we implement mandatory inspector training, routine unannounced inspections, and better tools for continuous monitoring, the cadence of our activity can be expected to accelerate.

The new curriculum for mandatory inspector training will affect the character of the accreditation site visit in distinct and durable ways. Inspection will be less about what is on paper and more about what is in practice. Inspectors will give more emphasis to direct observation, spend more time interviewing bench-level technologists, and examine the laboratory director’s leadership and management skills.

The new training—to be required first of team leaders and later of team members—means that all inspection teams will have the tools and techniques to ensure rigor and consistency. Inspectors will know how to work with bench-level personnel to assess the laboratory’s compliance with requirements. One technologist may be asked to take a specific specimen (perhaps one rarely seen, perhaps one that requires special precautions) from collection to analysis and reporting. Another might be asked to "teach" as if the inspector were a new member of the laboratory staff. A third might be called upon to complete a "drill-down" analysis of selected analytes through all the steps of testing.

The Laboratory Accreditation Program has introduced a new checklist to assess laboratory director performance. Laboratory directors must demonstrate direct involvement in the day-to-day functioning of the laboratory and effectiveness as a manager, teacher, and leader. New patient safety checklist questions have been added to help inspection teams determine whether laboratory professionals are comfortable in exercising their responsibility to identify, communicate about, and correct laboratory error.

The College has regulatory obligations under the Clinical Laboratory Improvement Amendments that must be observed. To that end, we continue to support the structured protocol under which the College shares information about laboratories that are being monitored for risk of noncompliance with the requirements of the Centers for Medicare and Medicaid Services, state authorities, and other appropriate accrediting bodies. We also continue to require that accredited laboratories promote and post a notice about the confidential toll-free hotline established to enable laboratory personnel to advise the College about quality concerns.

Unannounced routine inspections will be introduced this spring for all but a handful of laboratories in the United States, Canada, and Puerto Rico. (Scheduled inspections will continue for laboratories new to the program, as well as those providing forensic urine drug testing and reproductive health services.) Although unannounced inspections were controversial at first, I suspect it won’t be long before a lot of us will be wishing we could take credit for them. Quality is a state of mind, not a scheduled event. Our patients are entitled to know that every CAP-accredited laboratory is inspection-ready every day of the year. It’s like the difference between a young couple’s Valentine’s Day celebration and an established family’s nightly routines. Romantic restaurants are fun, but it’s the Tuesday night suppers that sustain us.

In addition to routine inspections, a percentage of accredited laboratories will participate in validation inspections to assess the effectiveness of program changes and the performance of inspection teams. The most powerful new tools to ensure sustained compliance, however, will be those derived from new hardware and software. Over the next two years, we will invest $9 million in powerful knowledge management capabilities. The new system will integrate a wealth of information available to the College via proficiency testing, accreditation reports, trend analyses, and complaints to create predictive models that will identify and monitor quality indicators. We have collected a great deal of information about laboratory medicine over the years, and when our systems begin to talk to each other, the result will be a new level of rigor based on concrete, readily replicated intelligence.

We have also made structural changes within the College to strengthen ties between the LAP and the CAP Board of Governors. New committees within the Commission on Laboratory Accreditation, chaired by R. Bruce Williams, MD, will monitor and modify our inspector education, responses to complaints, inspection processes, continuous compliance, and checklists. A newly created Council on Laboratory Accreditation chaired by Stephen N. Bauer, MD, will report directly to the Board of Governors, linking College leadership to the day-to-day work of the accreditation program.

There is a lot of news from the LAP, but one thing never changes: Our program succeeds in the field because pathologists and laboratory professionals who understand how a laboratory is supposed to work volunteer for inspection teams. If we are to strengthen the safety net that protects our patients, we need your support. Inspectors are the backbone of our program and the dynamic agents of change, with an important compliance function under federal law. They teach as they learn and model as they mentor. Yes, training and site visits take time, but training will soon be online, and, in any event, the rewards clearly justify the time required. This is an exciting time for the LAP, an excellent time to become more involved. Please consider it.

The College welcomes and encourages comments and questions about the Laboratory Accreditation Program. To ask a question or to volunteer for an inspection team, please call the LAP staff at 800-323-4040, option 1#, or send e-mail to accred@cap.org.

Dr. Sodeman welcomes communication from CAP members. Write to him at president@cap.org.