Abstract
Vol.43 No.2
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Practical management of an ART laboratory: implementation based on international guidelines and Japanese standards
JMOR, 43(2) 97-106, 2026
Assisted reproductive technology (ART) laboratories handle gametes and embryos that are highly sensitive to environmental changes. Therefore, laboratory management should comprehensively address the working environment, equipment, supplies, and prevention of incidents and accidents. This review summarizes practical ART laboratory management based on international guidance, including ESHRE recommendations, the Cairo Consensus, and ASRM/SRBT guidance, together with Japanese standards issued by the Japan Society of Obstetrics and Gynecology, JISART, and the Ministry of Health, Labour and Welfare. We also describe our institutional practices, including maintenance of an ISO Class 6-equivalent laboratory environment, workflow-based zoning, surface temperature monitoring of cryostorage tanks, barcode-assisted double checking, and a continuous improvement cycle. In Japan, ART laboratory management is supported by layered requirements from academic societies, accreditation bodies, and health insurance regulations. However, each facility must translate these requirements into practical standard operating procedures. Integrating international recommendations with domestic standards and facility-specific risk management may improve safety, traceability, and stable laboratory performance.
