2024 Volume 73 Issue 2 Pages 337-345
In recent years, the quality assurance of clinical testing has attracted attention in Japan, and the acquisition of third-party accreditation has rapidly been emphasized. Accordingly, the number of facilities that have acquired ISO 15189 certification is increasing. On the other hand, in the United States, due to the implementation of CLIA’88 (Clinical Laboratory Improvement Amendments Act 1988), all clinical laboratories that handle human specimens must be certificated by a clinical laboratory accreditation organization approved by the some government agencies. The largest and most traditional of these is the Laboratory Accreditation Program (LAP) provided by the College of American Pathologists (CAP). The National Cancer Center Hospital East has maintained ISO 15189 accreditation since 2013. Furthermore, in order to achieve our vision of “creating new world-class cancer care”, we have been aiming to obtain CAP accreditation since 2019. After about three years of preparation, we acquired CAP accreditation in August 2022. Based on our experience, we will report on the outline of CAP, the usefulness of the proficiency test, the efforts in the pathology laboratory for the inspection, the responses during the inspection, the corrective actions after the inspection, and issues identified in continuously maintaining CAP.
