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Article 6-11

第六条の十一

In the event of a medical accident, the administrator of a hospital, etc., pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must immediately conduct an investigation necessary to clarify the cause of the accident (hereinafter referred to as "medical accident investigation" in this Chapter).

病院等の管理者は、医療事故が発生した場合には、厚生労働省令で定めるところにより、速やかにその原因を明らかにするために必要な調査(以下この章において「医療事故調査」という。)を行わなければならない。

The administrator of a hospital, etc. is to seek the support necessary for conducting medical accident investigations from an academic organization related to medicine and medical science or any other organization specified by the Minister of Health, Labour and Welfare (in the case of an organization that is not a corporation, it is to be limited to an organization with a designated representative or administrator; referred to as "medical accident investigation support organization" in the following paragraph and Article 6-22).

病院等の管理者は、医学医術に関する学術団体その他の厚生労働大臣が定める団体(法人でない団体にあつては、代表者又は管理人の定めのあるものに限る。次項及び第六条の二十二において「医療事故調査等支援団体」という。)に対し、医療事故調査を行うために必要な支援を求めるものとする。

When a medical accident investigation support organization is requested to provide support in accordance with the provisions of the preceding paragraph, it is to provide the necessary support for medical accident investigation.

医療事故調査等支援団体は、前項の規定により支援を求められたときは、医療事故調査に必要な支援を行うものとする。

When the administrator of a hospital, etc. has completed a medical accident investigation, the administrator must immediately report the results to the medical accident investigation and support center set forth in Article 6-15, paragraph (1), pursuant to an Order of the Ministry of Health, Labour and Welfare.

病院等の管理者は、医療事故調査を終了したときは、厚生労働省令で定めるところにより、遅滞なく、その結果を第六条の十五第一項の医療事故調査・支援センターに報告しなければならない。

Prior to the submission of a report pursuant to the provisions of the preceding paragraph, the administrator of the hospital, etc. must explain to the bereaved family about the particulars specified by an Order of the Ministry of Health, Labour and Welfare; provided, however, that this does not apply when there is no bereaved family or the whereabouts of the bereaved family are unknown.

病院等の管理者は、前項の規定による報告をするに当たつては、あらかじめ、遺族に対し、厚生労働省令で定める事項を説明しなければならない。ただし、遺族がないとき、又は遺族の所在が不明であるときは、この限りでない。

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