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Article 15-3

第十五条の三

When the administrator of a hospital, clinic or birthing center wishes to entrust specimen testing, the administrator must do so to the following persons:

病院、診療所又は助産所の管理者は、検体検査の業務を委託しようとするときは、次に掲げる者に委託しなければならない。

an establisher of a sanitary laboratory registered under .; and

の登録を受けた衛生検査所の開設者

a person who performs specimen testing in a hospital, clinic or other places specified by an Order of the Ministry of Health, Labour and Welfare, and the buildings and equipment of the facilities where the person performs specimen testing, management organization, methods for ensuring the accuracy of specimen testing and other particulars conform to the standards specified by an Order of the Ministry of Health, Labour and Welfare as necessary for the proper performance of specimen testing.

病院又は診療所その他厚生労働省令で定める場所において検体検査の業務を行う者であつて、その者が検体検査の業務を行う施設の構造設備、管理組織、検体検査の精度の確保の方法その他の事項が検体検査の業務の適正な実施に必要なものとして厚生労働省令で定める基準に適合するもの

Beyond what is provided for in the preceding paragraph, when the administrator of a hospital, clinic, or birthing center wishes to entrust the operation of the hospital, clinic, or birthing center that are prescribed by Cabinet Order as having a significant influence on physicians' or dentists' diagnoses, on the services of midwives, or on the hospitalization or admission of patients, pregnant women, women in labor, or women resting after childbirth, the administrator must entrust the relevant operations to a party who conforms to the requirements prescribed by an Order of the Ministry of Health, Labour and Welfare as a party with the ability to properly undertake its operation, in accordance with the type of operation undertaken at the relevant hospital, clinic, or birthing center.

病院、診療所又は助産所の管理者は、前項に定めるもののほか、病院、診療所又は助産所の業務のうち、医師若しくは歯科医師の診療若しくは助産師の業務又は患者、妊婦、産婦若しくはじよく婦の入院若しくは入所に著しい影響を与えるものとして政令で定めるものを委託しようとするときは、当該病院、診療所又は助産所の業務の種類に応じ、当該業務を適正に行う能力のある者として厚生労働省令で定める基準に適合するものに委託しなければならない。

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