Patrick Godbey, MD
March 2021—I inspected my first lab as a pathology resident in 1988. Robert Baisden, MD, head of clinical pathology at Medical College of Georgia at the time, handed me a checklist one day and said we were going to do a laboratory inspection. Like that of so many pathologists, my introduction to the CAP came through the Laboratory Accreditation Program.
The Laboratory Improvement Program, LIP, is an essential component in the CAP’s efforts to ensure laboratory quality. Our inspection program is considered the gold standard around the world, and rightly so. Our checklists are the best textbooks on laboratory quality in existence. If you understand and put into place the elements spelled out in the checklists, you will have a quality lab. They are written and updated regularly by pathologists and other medical laboratory scientists, giving CAP members direct input into the process. After all, nobody knows a quality laboratory better than we do. The ultimate beneficiary of all of this is who it should be: the patient.
Dr. Godbey
CAP checklists are the same all over the world. I have inspected labs in Georgia, Florida, South Carolina, Saudi Arabia, and Singapore. The requirements are consistent across labs small and large. That’s why it means so much to be accredited by the CAP. I know my laboratory is a good one because it was inspected by the CAP and the CAP tells me so. Labs that do not go through CAP inspection might be good—might be—but if you are CAP inspected, then everyone knows you are, including you and those who work with you.
In the past year, our commitment to quality has been tested in new ways. I am so proud of how the CAP has handled laboratory inspections and proficiency testing during the COVID-19 pandemic. The CAP quickly developed proficiency products to help pathologists ensure they were running SARS-CoV-2 tests properly. Getting that out to the community so early in the pandemic helped labs produce accurate results at a time when low-quality results would have been devastating not only to patients but also to public health policy.
We also released, and frequently updated, an infographic designed to help pathologists understand exactly what they needed to do to verify or validate a new test. We put that and so much other critical information on the public part of the CAP website so it was available to the entire community, not just to CAP members and CAP-accredited laboratories. And since many laboratories had to bring up more than one SARS-CoV-2 test at once, we released Quality Cross Checks to help pathologists test concordance in detecting the same analyte across methods and platforms. We also updated our checklists to include new criteria about how labs had to report both negative and positive results for state and federal compliance.
Releasing all of that information quickly was crucial for CAP members and CAP-accredited laboratories, but behind the scenes it created a real challenge for the organization. At the time, the CAP was in the middle of being reapproved by the Centers for Medicare and Medicaid Services, a period during which we traditionally cannot issue new materials. We had to get special permission from the CMS to publish these essential guidelines and recommendations.
Of course, the pandemic and ensuing lockdowns also changed our laboratory inspection protocols. The CAP immediately issued extensions for labs that were in the process of being re-accredited but had to shift their focus to SARS-CoV-2 testing. As travel restrictions arose, we implemented a remote document review step to reduce the size of the inspection team needed on-site and the time they would have to spend in the lab. Later, we developed a virtual inspection process whereby no one had to travel or allow visitors into the laboratory. This was based on remote document sharing, temporary remote access to electronic document control systems where appropriate, and video meetings through which peer inspection teams could take a virtual tour of the lab, asking questions along the way. Some of the most successful elements of these approaches, such as having remote document review prior to the inspection, may be incorporated into the CAP’s accreditation process even after the pandemic is over.
I am truly impressed, but not at all surprised, at how the CAP community rallied to deliver the best laboratory quality even during the most challenging time many of us have ever faced. Amid tremendous pressure to bring up new tests and report on many more samples than usual, pathologists and staff associated with the CAP focused on ensuring quality operations in a tumultuous environment. I would especially like to thank CAP governor Mick Scanlan, MD, who serves as chair of the Council on Accreditation, and CAP staff members Denise Driscoll, senior director of laboratory accreditation and regulatory affairs, and Shelly Staat, senior manager of marketing programs, for their remarkable efforts to respond to the pandemic and to give our members clear, concise information to help them generate results of the highest quality.
One other topic that I would like to talk about is this year’s Pathologists Leadership Summit. It will take place May 1–4. Unfortunately, due to the pandemic, it will be a virtual event, but I believe it will be important for ensuring that we set our agenda and do everything we can to make sure pathologists’ voices are heard by our elected leaders. I am looking forward to participating and hope you will join me.
Dr. Godbey welcomes communication from CAP members. Write to him at president@cap.org.