Audit and Accreditation of ART Facilities in Japan; JISART’s Commitment Focusing on Quality Management Systems (QMS) and Patient Satisfaction

Abstract

In Japan in 2018, 247,402 cycles of oocyte retrieval were performed at 592 facilities and 56,979 ART babies were born. 1 in 16 new births were as a result of ART. There is presently no law regulating ART and each facility operates under a system of self-regulation based on the requirements of the Japan Society of Obstetrics and Gynaecology. In 2000, systems for staffing, quality and safety management were not clearly structured. JISART (The Japanese Institution for Standardizing Assisted Reproductive Technology) was set up in 2003 with a view to improving quality of treatment and patient satisfaction. It is comprised of 31 private clinics with over 500 annual oocyte retrievals and all members are ISO9001 certified. With the Reproductive Technology Accreditation Committee playing a central role, a Code of Practice, guidelines for quality and safety management in ART, and audit checklists have been created. Specialist physicians, embryologists, nurses, administration staff and a patient support group conduct audits triennially, covering some 245 points. With respect to physicians, the audits look at whether there are systems in place for patient examinations and professional development, and at treatment outcomes and risk management. For embryologists and nurses, they examine qualifications, knowledge and technique along with records of equipment inspections and consent forms. Further, patients are interviewed to ascertain their satisfaction with and suggested areas for improvement to facilities and personnel. In Japan, the situation regarding ART is undergoing great changes, with audits having changed from on-site to online due to the COVID-19 pandemic and the government considering whether ART should be covered by national health insurance. In the conference, I will talk about the current situation regarding audits and suggest issues for further consideration.