GC Labs’ pathology certification suspended after breast cancer surgery error from specimen mix-up

GC Labs, a specimen testing agency, has had its certification in pathology revoked for one month. This decision was made in response to an incident in which a woman underwent breast cancer surgery due to the agency's mishandling of specimen test results.

Last Friday, the Ministry of Health and Welfare announced that it had decided to revoke the certification after reviewing the results of an on-site inspection conducted by the Korean Society of Pathologists regarding the misidentification and alteration of specimen test results by GC Labs, following the Second Specimen Testing Certification Management Committee meeting held the previous day.

A woman who received a breast cancer diagnosis during a health check-up at a clinic last September underwent a partial mastectomy. Still, the cancer was later found to be benign. The incident occurred because GC Labs, which had received the specimen for testing from the clinic, mistakenly mixed up the test results with those of another woman and provided the incorrect results to the clinic.

The committee decided to suspend the certification for one month, “considering the severity of the issue and the extent of the harm caused.”

The decision was made considering that the patient's health had been harmed and that improvement efforts were insufficient, even after the fact was recognized. In addition, the panel also considered that GC Labs had previously been reviewed for a two-week suspension of certification due to violations, including discounting fees.

As a result, GC Labs will not be able to perform specimen testing or bill for testing fees in pathology during the suspension period. The specific implementation date will be determined after prior notification to GC Labs and consideration of its opinion.

The meeting, the first since the launch of the second committee, also discussed measures to improve the entrustment system.

The committee agreed to pursue the following initiatives: improving certification standards to enhance quality management; establishing an appropriate scope of duties for entrusting and entrusted institutions; developing measures to prevent the discounting of testing fees and re-entrustment/entrustment; and establishing an effective management system for the certification period and standards of entrusted institutions.

Specific directions for institutional improvements will be discussed with relevant academic societies, experts, and patient groups.

The second committee is composed of 11 members, including Professor Kong Gu of the Department of Pathology at Hanyang University College of Medicine as chair, as well as representatives from relevant academic societies, entrusted institutions, medical organizations, and government officials.

Incidents, like the recent specimen change, are critical issues directly related to public health and safety. All relevant parties must strive to ensure that the entire specimen testing process is managed more safely,” said Lee Jung-gyu, director-general of the ministry’s Health Insurance Policy Bureau. “We will use this incident as an opportunity to pursue comprehensive institutional reforms across the entire specimen testing outsourcing system.”