Committee Introduction

The Standard Development Committee develops, revises, and systematically manages the inspection checklists for the Outstanding Laboratory Accreditation Program. To maintain objectivity and consistency in accreditation inspection, the division continuously manages inspection Standards and develops inspection checklists by reflecting domestic and international diagnostic testing standards and accreditation inspection experience. The division also operates Q&A for inspection Standards and collects feedback from inspection sites so that inspection Standards can be applied reasonably in laboratory practice. The Standard Development Committee Working Committee includes one or two experienced responsible laboratory physicians for each diagnostic testing field to review the expertise and applicability of inspection Standards. 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.

Standard Revision

Requirement revision is a core function of the Standard Development Committee and is carried out by comprehensively reviewing diverse feedback collected during accreditation inspection, statistical analysis of scores by Standard, domestic and international regulations, and professional society guidelines.

Revision Cycle

Application Process for New Standards

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

Inspection Standards Q&A

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

Standard Development Committee On-site Inspection

The Standard Development Committee directly participates in Outstanding Laboratory Accreditation on-site inspections to confirm laboratory operations and actual application of inspection Standards in the field. This is used to assess the effectiveness and applicability of inspection Standards and as reference material for future Standard revision.

Accreditation Guidance

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