Personnel Standards

1. Specialists

• The laboratory director must be a laboratory medicine specialist.
• The basic requirements for the responsible specialist are as follows.
• Experience requirements: both of the following must be met.
• At least one year of experience in the Laboratory Management field.
• Participation as an inspector in the Outstanding Laboratory Certification inspection.
• At least once within the two years prior to the inspection date.
• If participation as an inspector is difficult, completion of the Certification Inspection Guidance Workshop at least once within the two years prior to the inspection date may substitute.
• For a new specialist:
• Completion of Laboratory Medicine Foundation education during residency.
• At least one experience as inspected personnel during residency.
• Observation as an inspector during residency.
• Laboratory medicine specialists must participate as inspectors in the Outstanding Laboratory Certification inspection at least once per year.
• An appropriate number of specialists must work full-time.
• This is calculated based on the professional personnel area score under the Criteria for Calculation and Application of Specimen Testing Quality Add-on Rate, according to the number of full-time laboratory medicine specialists in the third previous quarter relative to 5% of the total relative value points for specimen tests directly performed or referred in during the third previous quarter.

[Use of Education Program Completion Certificates]

2. Medical Technologists

• Medical technologists must have appropriate qualifications, and licenses must be available.
• The responsible medical technologist must have four years of experience performing the relevant work.
• Medical technologists in each field must complete laboratory certification education.
• An appropriate number of full-time medical technologists must be present so that quality management can be performed.

Checklist Requirement Evaluation Criteria

• If evaluation criteria or deduction criteria are specified in the requirement description, those criteria are applied first.
• Evaluation is performed by quarter-point deduction.

Score	Evaluation Criteria (policy and/or implementation)
Full score	Appropriate policy and/or faithful implementation.
25% deduction	Some insufficiency in policy or implementation at a minor level.
50% deduction	Multiple insufficiencies in policy or implementation.
75% deduction	Important elements of policy or implementation are insufficient, or most elements are insufficient.
No (0 points)	No policy exists or there is no implementation.

• Requirement classification system

Requirement Type	Classification Criteria	Action Required When the Requirement Is Not Met
Core Requirement: C (Core standards)	Standards that are essential for clinical laboratory quality improvement and, if not met, may cause fatal or serious defects in the accuracy of test results.	If evaluated as No, the deficiency must be corrected and reinspection must be requested six months or later from the inspection date.
Required Requirement: R (Required standards)	Requirements on which the laboratory must focus its capabilities for clinical laboratory quality improvement.	If a required requirement is evaluated as No or scores below 50%, one-year certification is granted even if the score rate is 90% or higher; for special certification fields (Flow Cytometry, Histocompatibility Testing, Cytogenetic Testing, Molecular Diagnostic Testing, and Point-of-Care Testing), one-year certification is granted only for the relevant field.
Basic Requirement: B (Basic standards)	Standards that must basically be in place for clinical laboratory quality improvement and that are neither core nor required requirements.	Findings or score deductions identified in basic requirements are corrected by the laboratory itself, and correction is confirmed at the next on-site inspection.

Certification Criteria and Certification Period

• The certification criteria and periods according to the score rate out of the total points for items excluding Not Applicable in each field are as follows.
• Below 70%: Not eligible for certification. Certification is not granted, and reapplication for certification inspection is possible after at least six months.
• 70% or higher and below 80%: Eligible for certification. Certification period is six months.
• 80% or higher and below 90%: Eligible for certification. Certification period is 12 months.
• 90% or higher in all fields: Eligible for certification. Certification period is 12 months, and after deliberation by the Laboratory Certification Committee, the following year's on-site inspection is replaced by document review.
• If only one of the following fields scores 80% or higher and below 90% while all other fields score 90% or higher, the following year may be replaced by document review, but on-site inspection is performed only for the one field below 90%: Flow Cytometry, Histocompatibility Testing, Cytogenetic Testing, Molecular Diagnostic Testing, or Point-of-Care Testing. If two or more fields score 80% or higher and below 90%, one-year certification is granted for all fields.
• For a new institution, even if the score is 90% or higher, the maximum on-site inspection certification period is one year for the first two years from the initial inspection.
• The certification criteria and period for referral testing certification according to score rate are as follows.
• Score rate 80% or higher: one-year certification.
• Score rate 70% or higher: six-month certification.
• Score rate below 70%: not certified; reapplication is possible after at least six months.
• If testing in a new field is started during the certification period, additional certification must be obtained within three months after implementation.
• Certification for the Comprehensive Verification field requires a Laboratory Management field score rate of 80% or higher, no item scoring 0 points across all Comprehensive Verification field items, and a Comprehensive Verification field score rate of 80% or higher.
• Certification start date
• The first day of the first month of the quarter following the inspection date.
• Example: If certification inspection is performed on May 20 in the second quarter, the certification period begins on July 1, the start of the third quarter, and continues through June 30 of the following year.
• Cancellation of certification and changes to certification details
• Even during the certification period, certification may be cancelled or certification details may be changed if changes are identified.
• Certification is cancelled if there is no full-time specialist for three months or longer.