Inspection Team Composition

Composition of the Inspection Team

• When a certification application is received, the Foundation designates an inspection team leader, and the team leader consults with the applicant institution to determine the inspection schedule and compose the inspection team.
• The Foundation then officially notifies the applicant institution of the inspection schedule and inspection team composition.

Qualification Requirements for Inspection Team Leaders

• The inspection team leader is responsible for the overall conduct of the certification inspection and must be a specialist who meets the following requirements.
• At least seven years after specialist board certification.
• Participation in at least two laboratory certification inspections as an inspector.
• Completion of inspection team leader training.
• If the individual has prior experience as an inspection team leader, qualification may be recognized regardless of training status.

Primary Roles of the Inspection Team Leader

• Consultation with the inspected institution on the inspection schedule.
• Composition of an inspection team appropriate for the inspection fields.
• Management of the schedule and overall conduct on the inspection day.
• Compilation of inspection results and reporting to the Foundation.

Qualification Requirements for Inspectors

• Inspectors evaluate certification inspection requirements and prepare inspection reports.
• Inspectors must meet at least two of the following conditions.
• Completion of certification inspection education or a workshop within the past two years.
• For a new specialist, all of the following are required: ① attendance at two certification education workshops during residency, ② experience as an inspected participant at least once, and ③ observer experience as an inspector at least twice.
• Full membership in the relevant society and registration on the Foundation inspector list.
• Recent inspection activity experience and recognition of qualification by the Foundation.

Considerations When Assigning Inspectors

• To ensure fair inspection, the inspection team leader assigns inspectors after considering the following.
• Exclusion of persons who participated in inspection of the same institution within the past two years.
• Exclusion of inspectors affiliated with the same institution as the inspected institution.
• Exclusion of inspectors from the same training hospital as the inspected institution.
• Exclusion of persons who refused approval as an inspector.

Inspection Team Composition Criteria

• The required number of inspectors varies according to the number of inspection fields. For major fields, it is recommended that one inspector be assigned to one field.

Inspection Day

Example Inspection-Day Schedule

• 09:00-09:15, Inspectors assemble and inspection team meeting.
• 09:15-09:30, Introduction of the inspection team and laboratory staff, and inspection briefing.
• 09:30-12:00, Inspection.
• 12:00-13:00, Lunch.
• 13:00-16:30, Inspection and interview with the head of the institution if needed. The schedule and content of any interview with the head of the institution should be discussed with the team leader in advance.
• 16:30-17:00, Inspection team meeting.
• 17:00-17:30, Overall inspection comments.
• 17:30, End of inspection.

Inspection Conduct

• The inspection team leader oversees the inspection and manages the inspection schedule.
• Inspectors for each field conduct inspection of their assigned fields.
• All separately operated laboratories, such as emergency laboratories and cancer center laboratories, are included in the scope of inspection.

Confirmation of Inspection Results

• After the inspection is completed, inspectors explain findings and matters requiring improvement.
• After reviewing the inspection report, the responsible specialist or laboratory manager signs it.

Objections Related to Inspection

• If there is an objection to inspection content, the principle is to confirm and resolve it on site on the inspection day through sufficient communication.
• If an objection remains after the inspection, the institution may file an appeal with the Foundation within one week after the inspection or by the end of the inspection month. However, an appeal may not be filed after the overall comments by adding new materials that were not submitted to the inspectors during the on-site inspection.

Inspection Result Report

• When the on-site inspection is completed, the inspection team organizes the inspection results and submits them to the Foundation. The submitted materials are as follows.
• Inspection checklist.
• Inspection team leader report.
• Inspector reports.
• Comments from the laboratory director.
• The inspection team leader compiles the evaluations and comments of each inspector and submits the inspection results to the Foundation.

Deliberation by the Laboratory Certification Committee

• The Assessment Division reviews the submitted inspection results and scores and refers them to the Laboratory Certification Committee for deliberation.
• Whether certification is granted and the certification period are determined according to the committee deliberation result.
• Certification start date: the certification start date is applied from the first day of the first month of the quarter following the inspection date.