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Section 2 Medical Accident Investigation and Support Center第二節 医療事故調査・支援センター
Article 6-15第六条の十五
Article 6-15, paragraph (1)
The Minister of Health, Labour and Welfare, upon application, may designate as a medical accident investigation and support center a general incorporated association or general incorporated foundation whose purpose is to contribute to ensuring the safety of medical care by conducting medical accident investigations and providing support for medical accident investigations conducted by the administrators of hospitals, etc. in which medical accidents have occurred, and which is found to be capable of appropriately and reliably performing the services prescribed in the following Article.
When the Minister of Health, Labour and Welfare has made a designation under the provisions of the preceding paragraph, the minister must make public the name, address, and office location of the relevant medical accident investigation and support center.
When a medical accident investigation and support center intends to change its name, address, or the location of its office, the center must notify the Minister of Health, Labour and Welfare to that effect in advance.
When the Minister of Health, Labour and Welfare has received a notification under the preceding paragraph, the minister must make public the particulars pertaining to the relevant notification.
厚生労働大臣は、前項の規定による届出があつたときは、当該届出に係る事項を公示しなければならない。
Article 6-16第六条の十六
Article 6-16, paragraph (1)
The medical accident investigation and support center are to perform the following services:
医療事故調査・支援センターは、次に掲げる業務を行うものとする。
Article 6-16, paragraph (1), item (i)
organize and analyze the information collected through the report under the provisions of Article 6-11, paragraph (4):
第六条の十一第四項の規定による報告により収集した情報の整理及び分析を行うこと。
Article 6-16, paragraph (1), item (ii)
report the results of the organization and analysis of the information under the preceding item to the administrators of hospitals, etc. that have made a report under the provisions of Article 6-11, paragraph (4):
conduct the investigation set forth in paragraph (1) of the following Article and report the results to the administrator and the bereaved family set forth in the same paragraph:
次条第一項の調査を行うとともに、その結果を同項の管理者及び遺族に報告すること。
Article 6-16, paragraph (1), item (iv)
provide training on knowledge and skills pertaining to medical accident investigation to those engaged in medical accident investigation:
医療事故調査に従事する者に対し医療事故調査に係る知識及び技能に関する研修を行うこと。
Article 6-16, paragraph (1), item (v)
provide consultation on the implementation of medical accident investigation and provide necessary information and support:
医療事故調査の実施に関する相談に応じ、必要な情報の提供及び支援を行うこと。
Article 6-16, paragraph (1), item (vi)
promote dissemination of information and awareness-raising about prevention of recurrence of medical accidents: and
医療事故の再発の防止に関する普及啓発を行うこと。
Article 6-16, paragraph (1), item (vii)
beyond what is listed in each of the preceding items, to perform services necessary to ensure the safety of medical care.
前各号に掲げるもののほか、医療の安全の確保を図るために必要な業務を行うこと。
Article 6-17第六条の十七
Article 6-17, paragraph (1)
The medical accident investigation and support center may conduct necessary investigations when the administrator of a hospital, etc. where a medical accident has occurred or a bereaved family requests an investigation of the relevant medical accident.
When the medical accident investigation and support center finds it necessary to conduct the investigation set forth in the preceding paragraph, it may request the administrator set forth in the same paragraph to provide written or oral explanations or submit materials or other forms of necessary cooperation.
The administrator prescribed in paragraph (1) must not refuse a request made by the medical accident investigation and support center pursuant to the preceding paragraph.
When the administrator prescribed in paragraph (1) refuses a request under the provisions of paragraph (2), the medical accident investigation and support center may make a public announcement to that effect.
When the medical accident investigation and support center has completed the investigation under paragraph (1), it must report the results of the investigation to the administrator and the bereaved family prescribed in the same paragraph.
When the medical accident investigation and support center performs the services listed in each item of Article 6-16 (hereinafter referred to as "investigation services, etc."), prior to performance of such services, the center must establish rules for investigation services, etc. covering particulars concerning the implementation method of investigation services, etc. and other particulars specified by an Order of the Ministry of Health, Labour and Welfare (referred to as the "service rules" in the following paragraph and Article 6-26, paragraph (1), item (iii)), and obtain approval from the Minister of Health, Labour and Welfare. The same applies when the medical accident investigation and support center intends to change the relevant rules.
When the Minister of Health, Labour and Welfare finds that the service rules approved under the preceding paragraph have become inappropriate for the proper and reliable implementation of the investigation services, etc., the minister may order that the relevant service rules be changed.
Each business year, the medical accident investigation and support center, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must prepare a business plan and a budget for income and expenditure with respect to the investigation services, etc. and obtain the approval from the Minister of Health, Labour and Welfare. The same applies when the medical accident investigation and support center intends to change the relevant business plan and budget.
The medical accident investigation and support center, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must prepare and submit to the Minister of Health, Labour and Welfare a business report and a statement of income and expenditure with respect to the investigation services, etc. after the end of each business year.
The medical accident investigation and support center must not suspend or abolish all or part of the investigation services, etc. without obtaining approval from the Minister of Health, Labour and Welfare.
No officer or employee of the medical accident investigation and support center, or any former officer or employee thereof must divulge any secret obtained in connection with the investigation services, etc. without justifiable grounds.
The medical accident investigation and support center may entrust a part of the investigation services, etc. to a medical accident investigation support organization.
医療事故調査・支援センターは、調査等業務の一部を医療事故調査等支援団体に委託することができる。
Article 6-22, paragraph (2)
An officer or employee of a medical accident investigation support organization entrusted with the investigation services, etc. under the preceding paragraph, or a person who used to be such an officer or employee must not divulge any secret obtained in connection with the relevant investigation services, etc. entrusted to them without justifiable grounds.
The medical accident investigation and support center, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must keep books, describe particulars specified by an Order of the Ministry of Health, Labour and Welfare concerning the investigation services, etc. therein, and store them.
When the Minister of Health, Labour and Welfare finds it necessary in order to ensure the proper operation of investigation services, etc., the minister may order the medical accident investigation and support center to make necessary reports on the status of the investigation services, etc. or assets, or have the relevant officials enter the office of the medical accident investigation and support center and inspect the status of the investigation services, etc. or books, documents or other objects.
The official who enters and inspects under the provisions of the preceding paragraph must carry a certificate for identification and present it to the persons concerned.
The authority under the provisions of paragraph (1) must not be construed as being granted for the purpose of criminal investigation.
第一項の規定による権限は、犯罪捜査のために認められたものと解釈してはならない。
Article 6-25第六条の二十五
Article 6-25, paragraph (1)
The Minister of Health, Labour and Welfare, to the extent necessary to enforce the provisions of this Section, may issue to the medical accident investigation and support center orders necessary for the supervision of the investigation services, etc.
When the medical accident investigation and support center falls under any of the following items, the Minister of Health, Labour and Welfare may rescind the designation under the provisions of Article 6-15, paragraph (1) (hereinafter referred to as "designation" in this Article):
when the medical accident investigation and support center is found to be unable to perform investigation services, etc. appropriately and reliably;
調査等業務を適正かつ確実に実施することができないと認められるとき。
Article 6-26, paragraph (1), item (ii)
when there has been a wrongful act with regard to the designation; or
指定に関し不正の行為があつたとき。
Article 6-26, paragraph (1), item (iii)
when the medical accident investigation and support center has violated the provisions of this Section or an order or disposition thereunder, or has performed investigation services, etc. without complying with the service rules approved under Article 6-18, paragraph (1).
When the Minister of Health, Labour and Welfare has rescinded a designation pursuant to the provisions of the preceding paragraph, the minister must make a public announcement to that effect.
厚生労働大臣は、前項の規定により指定を取り消したときは、その旨を公示しなければならない。
Article 6-27第六条の二十七
Article 6-27, paragraph (1)
Beyond what is provided for in this Section, necessary particulars concerning the medical accident investigation and support center are to be specified by an Order of the Ministry of Health, Labour and Welfare.