Outstanding Laboratory Certification Program

• This refers to laboratory certification obtained by an institution with an appropriate number of full-time specialists, including at least one actively practicing specialist.
• For general laboratory certification, Laboratory Management and General Laboratory Medicine are mandatory fields, and the institution is inspected for the relevant testing services.
• General fields: Diagnostic Hematology, Clinical Chemistry, Urinalysis and Body Fluid Analysis, Diagnostic Immunology, Clinical Microbiology, and Transfusion Medicine.

Referral Medical Laboratory Certification

• This is certification obtained after a referral medical laboratory has been granted Outstanding Laboratory Certification and then undergoes certification inspection for referral testing.

Laboratory Certification Committee

• Final deliberation for the Laboratory Certification Program.
• Determination of whether certification is granted and the certification period.
• Differential determination of the certification period through deliberation based on checklist item scores from the certification inspection.

Certification Period

• Six months, one year, or two years depending on inspection performance.
• For a new institution, the maximum on-site inspection certification period is one year for the first two years from the initial inspection.

Certification Start Date

• The first day of the first month of the quarter following the inspection date (quarterly certification).
• The Laboratory Certification Committee deliberates certification early in the month following the inspection and notifies the institution.
• In principle, the inspection month cannot be changed.
• If the inspection month must be changed due to unavoidable circumstances, it may be moved earlier within the same quarter but may not be postponed.

Major Changes in the Laboratory

• Major changes must be reported to the Laboratory Medicine Foundation within one month.
• Supporting documents such as the medical institution establishment permit and laboratory floor plan are required.
• Change in specialist personnel.
• Change in the name or number of the healthcare institution.
• Change in laboratory location.
• Start of testing in a new field.

Calculation of Specimen Testing Quality Add-on Fee

Certification Items for the Outstanding Laboratory Area

• The Outstanding Laboratory area applies the assessment results from three quarters prior, and the corresponding scores are as follows.
• Institution scoring 90 points or higher in all applicable inspected fields: 35 points.
• Institution scoring 80 points or higher in all applicable inspected fields: 25 points.
• Institution scoring 70 points or higher in all applicable inspected fields: 15 points.
• “All applicable inspected fields” include Laboratory Management and all fields being performed at the time of inspection.
• Comprehensive Verification, Point-of-Care Testing, and Referral Testing are excluded.
• The score for each field is expressed as the percentage of points earned out of the total points for items excluding “not applicable” (for example, 90% = 90 points).

Laboratory Personnel: Board-certified Clinical Pathologist

To grant Outstanding Laboratory Certification, the laboratory must have an appropriate number of full-time laboratory medicine specialists (Board-certified Clinical Pathologist), including at least one actively practicing specialist responsible for the laboratory.

Actively Practicing Specialist (Board-certified Clinical Pathologist)

• A specialist who performs core duties of a laboratory medicine specialist at the institution for at least 20 hours per week, including quality control, interpretation, and comprehensive verification.
• If the specialist does not work at the institution for one month or longer due to overseas business travel, overseas training, or similar reasons, that period is excluded from actively practicing specialist status.
• Reference: Full-time laboratory medicine specialist: a specialist who works exclusively at an institution that has at least one actively practicing specialist.

Laboratory Personnel: Medical Technologists

To grant Outstanding Laboratory Certification, the laboratory must have an appropriate number of qualified medical technologists.