Inspection Procedure - On-site Inspection

Inspection Preparation

• The documents that the inspected institution must prepare and submit to the inspection team leader are as follows.
• Personnel summary, ranks, positions, job categories, and assigned duties.
• List of test items performed by field.
• Annual test volume statistics.
• Number of separately operated laboratories and list of major facilities and equipment.
• Referral testing items and volume, and regional scope of referral clients.
• Previous on-site inspection evaluation report.
• Items to be prepared in the laboratory on the inspection day are as follows.
• Computers capable of online inspection with internet access, preferably available for each inspector.
• Various logs and registers required for inspection.
• Internal quality control records and related materials.
• If possible, separate copies for inspection of the Laboratory Management field.

Inspection Conduct

• In general, the inspection proceeds in the order of laboratory introduction, introduction of inspectors and inspected personnel, on-site laboratory visit, and inspection.
• The procedure may vary according to laboratory circumstances.
• If there is an interview with the head of the institution or other personnel, the laboratory manager informs the reserved time in advance.
• During the interview, the inspection team leader summarizes the purpose of the inspection, future directions for development, and matters needed by the laboratory.
• For document review, after self-assessment is conducted and the assessment report and improvement status or plan for findings and recommendations from the previous year's on-site inspection are submitted, the Assessment Division may adjust scores, and final deliberation is performed by the Laboratory Certification Committee.

Overall Comments and Report Signature

• After completing the inspection, findings and recommendations are communicated orally to the inspected personnel and others in attendance.
• The responsible specialist or director for each field at the inspected institution reviews the inspection report on the Foundation website and signs the report.
• Report signature is completed in Institutional Member Certification Inspection > Details > Report Signature by entering the inspection report confirmation ID, password, and name of the responsible specialist, then clicking confirm so that the report status becomes signed.
• A report that has been signed cannot be modified.

Appeal

• If there is an objection to the inspection result, the institution completes an appeal application and sends it to the Foundation by e-mail.
• The appeal application form can be downloaded from the Laboratory Medicine Foundation website.
• An appeal may be filed within one week after the inspection or by the end of the inspection month.
• An appeal cannot be filed using materials that were not submitted to inspectors during the on-site inspection.
• The appeal is reviewed by the Assessment Division Working Committee.
• The Foundation does not receive additional materials unless requested by the inspector.
• The review result is notified to the institution after review by the Laboratory Certification Committee.

Resident Participation

• Residents in laboratory medicine may observe as inspectors or inspected personnel for educational purposes.
• Whether a resident may observe as an inspector is determined by the Assessment Division considering region, hospital size, and other factors.
• Resident observation as an inspector is notified to the inspection team leader.