Laboratory Medicine Foundation

Outstanding Laboratory Accreditation Program

This refers to laboratory accreditation obtained by an institution with an appropriate number of full-time laboratory physicians, including at least one on-site laboratory physician.
For general laboratory accreditation, 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 Accreditation

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

Laboratory Accreditation Committee

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

Accreditation Period

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

Accreditation Start Date

The first day of the first month of the quarter following the inspection date (quarterly accreditation).
The Laboratory Accreditation Committee deliberates accreditation 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 laboratory physician personnel.
Change in the name or number of the healthcare institution.
Change in laboratory location.
Start of testing in a new field.

Calculation of Laboratory Test Quality Incentives

Accreditation 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: Laboratory Physician

To grant Outstanding Laboratory Accreditation, the laboratory must have an appropriate number of full-time laboratory physicians (Laboratory Physician), including at least one on-site laboratory physician responsible for the laboratory.

On-site Laboratory Physician (Laboratory Physician)

A laboratory physician who performs core duties of a laboratory physician at the institution for at least 20 hours per week, including quality control, interpretation, and comprehensive verification.
If the laboratory physician 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 on-site laboratory physician status.
Reference: Full-time laboratory physician: a laboratory physician who works exclusively at an institution that has at least one on-site laboratory physician.