The specimen testing agency GC Labs received a 'one-month certification cancellation' sanction in the pathology field. This is related to the case where a woman who was not a cancer patient received breast cancer surgery due to the mismanagement of specimen testing results.
The Ministry of Health and Welfare stated on the 1st that it decided this based on discussions about measures after receiving a report on the field audit results of the Korean Society of Pathologists related to the specimen testing incident at GC Labs from the second Certification Management Committee for Specimen Testing Agencies.
A woman underwent breast cancer surgery after being diagnosed with breast cancer during an examination at Clinic A last September, but it turned out she did not have cancer. This incident occurred because GC Labs, which accepted the specimen testing from Clinic A, confused the results with those of another woman.
The Commissioner stated that the committee decided to cancel the pathology field certification for one month, considering the seriousness of the matter and the severity of the harm caused. It was taken into account that actual harm to patient health occurred, and that there were insufficient improvement efforts even after recognizing this fact. Additionally, past violations such as discounted service fees, which involved examining the cancellation of certifications, were also reflected.
During the cancellation period, GC Labs cannot conduct specimen testing or claim testing fees in the pathology field. The specific implementation timing will be finalized after prior notification and the submission of opinions regarding GC Labs.
This meeting was the first since the establishment of the second committee, and improvements to the entrusted testing system were also discussed. The second committee is composed of a total of 11 members, including the Chairperson, a professor from Hanyang University College of Medicine's Department of Pathology, representatives from relevant academic societies, testing agencies, the medical community, and government.
Lee Jung-kyu, the Director of Health Insurance Policy at the Ministry, noted, "Incidents like this specimen change are serious matters directly related to the lives and safety of the public, and all relevant parties must work to manage every aspect of specimen testing more safely," adding, "We will push for systemic improvements in the entrusted specimen testing process based on this incident."