Division Introduction

The Checklist Management Division develops, revises, and systematically manages the inspection checklists for the Outstanding Laboratory Certification Program. To maintain objectivity and consistency in certification inspection, the division continuously manages inspection requirements and develops inspection checklists by reflecting domestic and international diagnostic testing standards and certification inspection experience. The division also operates Q&A for inspection requirements and collects feedback from inspection sites so that inspection requirements can be applied reasonably in laboratory practice. The Checklist Management Division Working Committee includes one or two experienced responsible specialists for each diagnostic testing field to review the expertise and applicability of inspection requirements. The target fields include Laboratory Management, Diagnostic Hematology, Clinical Chemistry, Diagnostic Immunology, Clinical Microbiology, Flow Cytometry, Cytogenetic Testing, Molecular Diagnostic Testing, Transfusion Medicine, Histocompatibility Testing, Point-of-Care Testing, Comprehensive Verification, and Referral Testing.

Requirement Revision

Requirement revision is a core function of the Checklist Management Division and is carried out by comprehensively reviewing diverse feedback collected during certification inspection, statistical analysis of scores by requirement, domestic and international regulations, and professional society guidelines.

Revision Cycle

Application Process for New Requirements

• Newly developed requirements are operated as recommended requirements for one year.
• Comments received and assessment results during the recommendation period are analyzed to determine whether the requirements will be formally incorporated. Depending on the case, the recommended status may be maintained or the requirement may be excluded from the inspection checklist.

Inspection Requirement Q&A

The Checklist Management Division operates Q&A related to inspection requirements to support understanding of those requirements. Questions or comments about requirements may be submitted through the Inspection Requirement Q&A board on the Laboratory Medicine Foundation website, and the Checklist Management Division reviews them and posts responses. Comments and questions raised through this process are used to maintain consistency in requirement interpretation and, when necessary, are reflected in review for future requirement revision.

Checklist Management Division On-site Inspection

The Checklist Management Division directly participates in Outstanding Laboratory Certification on-site inspections to confirm laboratory operations and actual application of inspection requirements in the field. This is used to assess the effectiveness and applicability of inspection requirements and as reference material for future requirement revision.

Certification Inspection Guidance

Every year after requirement revision is completed, the Foundation holds Certification Inspection Guidance to provide information and education on revised inspection requirements and major changes. The guidance also explains requirement interpretation and points to note, and collects participant feedback for future requirement revision.