First Japanese hospital lab earns CAP accreditation

Despite the advent of aids like LEAP, NCCE’s two-year journey to CAP accreditation was not without struggle. Weeks after starting the process, COVID-19 hit. “While virtual meetings seem commonplace now, at the time everything was all new,” Dr. Ishii said. “But we learned fast. We had to.”

Projects were established using the Japanese language version of LEAP software, and CGI coaches initiated virtual meetings several times weekly. (They’re called coaches because their primary function is to drive the process while technical support is mainly incorporated into LEAP.) As time passed, CGI’s technical consultants were finally able to make hospital visits, but even then the process was driven by the software and supported by asking questions and requesting document and process reviews online. After all the projects were assigned, the building of the necessary processes was accomplished with production-line–like efficiency. Nearly two years in, NCCE was ready.

CGI initially did mock inspections virtually, until consultants and coaches were able to visit the hospital. “Laboratory staff seemed surprised when inspectors asked questions of bench technologists regarding their role in maintaining CAP standards,” Colby says. “But, to their credit, the NCCE staff soon appreciated that CAP processes aren’t merely about documents or the sole concerns of the QA department. CAP accreditation is more about implementing the processes articulated in the documented procedures and about real people having real communication and a meaningful understanding resulting in real actions.” Ultimately, it is about reshaping these actions into daily routines, he says, “essentially transforming CAP standards until they become a shared habit.” In Colby’s experience, this conceptual difference is new to many ISO-centric laboratories, in which document management seems to be at the center of quality control systems.

NCCE’s laboratory and hospital staff were in for even more and bigger surprises when the CAP inspectors arrived.

“One of the greatest things about working with the CAP over the last three decades has been the CAP inspectors,” Colby says. The team leader for the NCCE inspection was Richard Scanlan, MD, of the CAP Council on Accreditation. Other members of the team were Robert Baisden, MD (long-time leader of international inspections); Kailash Sharma, MD (microbiology and anatomic pathology); Sainan Wei, MD, PhD (molecular specialist); and Denise Driscoll (CAP senior director of accreditation and regulatory affairs). The full inspection team consisted of nearly 20 technical specialties. “We are here as your peers and colleagues,” Dr. Scanlan told a nervous NCCE staff in his opening remarks, “and we hope to learn from you and, where we can, act as teachers and mentors.”

The CAP inspectors erased all doubts and jitters during the three-day inspection. Dr. Baisden emphasized the importance of external proficiency testing and taught staff about statistical outliers and how to best evaluate proficiency testing results. Dr. Scanlan, a transfusion medicine expert, explained the use and benefits of new platelet storage techniques in trauma cases. Dr. Wei led her molecular pathology group through the intricacies of validating next-generation sequencing oncology markers using the CAP checklist as a teaching guide, and Dr. Sharma guided staff through the preanalytical requirements for anatomic pathology and suggested areas for improvement. The CAP’s Driscoll tied everything together with the laboratory general checklist, answering questions and emphasizing how important it is to understand the benefits of each requirement and the associated risks of noncompliance.

Deficiencies and recommendations were loaded into the LEAP CAPA (Corrections and Preventive Actions) system and a root-cause analysis was performed and plans laid for corrective actions to take place and be reported to the CAP. NCCE received its official notification of CAP accreditation in September 2022.

“Ultimately,” Colby says, “the true worth and benefits of CAP accreditation to NCCE, its patients, and research partners is this: that enduring and intrinsic value is best achieved by making CAP principles and practices a daily foundation of the laboratory’s culture and CAP standards a shared habit. To me, that is where the magic happens.”

Steve Ziolkowski is a writer focused on Japan and Asia. He was formally the managing director of Oxford University Press, Japan.