[Challenges for Certification of ISO 15189: Remarks of the Chairperson].

Abstract

In the Tohoku region, the evacuation of residents due to the Great East Japan Earthquake and subsequent accident at the Fukushima Dai-ichi Nuclear Power Plant has been prolonged due to radioactive contamination and delays in the construction of coastal areas. The destruction of local communities by the extended evacu- ation resulted in an increase of residents' health risks. Under such circumstances, the responsibilities of medical services are increasing more than before the earthquake, and even in the clinical laboratory, an in- crease in workload and higher quality assurance of examinations are required. The acquisition of ISO 15189 certification has recently been advanced as a means of guaranteeing the quality of laboratories, but in the Tohoku district, only 4 facilities (1 university hospital) have acquired it. Recent changes whereby ISO 15189 must be acquired by clinical research core hospitals and the "additional payment for the international standard management of samples" being newly established from April 2016 have promoted the acquisition of ISO 15189 certification. Therefore, at the 48th Tohoku Regional Congress of the Japanese Society of Labor- atory Medicine, we organized a symposium, entitled: "Challenges for Certification of ISO 15189".