第十六条の三
The administrator of an advanced treatment hospital must undertake the following particulars pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare:
特定機能病院の管理者は、厚生労働省令の定めるところにより、次に掲げる事項を行わなければならない。
providing advanced medical care;
高度の医療を提供すること。
carrying out development and evaluation of advanced medical care techniques;
高度の医療技術の開発及び評価を行うこと。
carrying out training in advanced medical care;
高度の医療に関する研修を行わせること。
ensuring a high level of medical safety;
医療の高度の安全を確保すること。
systematically managing the records listed under Article 22-2, items (iii) and (iv);
第二十二条の二第三号及び第四号に掲げる諸記録を体系的に管理すること。
when a request to view the records listed in Article 22-2, item (iii) or (iv) has been received from a physician who wishes to refer a patient to the relevant advanced treatment hospital or from other persons as prescribed by an Order of the Ministry of Health, Labour and Welfare, making available for inspection the records that are prescribed by an Order of the Ministry of Health, Labour and Welfare as having no risk of harming patient confidentiality, except where there are justifiable grounds for not doing so;
当該特定機能病院に患者を紹介しようとする医師その他厚生労働省令で定める者から第二十二条の二第三号又は第四号に掲げる諸記録の閲覧を求められたときは、正当の理由がある場合を除き、当該諸記録のうち患者の秘密を害するおそれのないものとして厚生労働省令で定めるものを閲覧させること。
other particulars as prescribed by an Order of the Ministry of Health, Labour and Welfare.
その他厚生労働省令で定める事項
The administrator of an advanced treatment hospital, when carrying out particulars specified by an Order of the Ministry of Health, Labour and Welfare as important particulars concerning the management and operation of the advanced treatment hospital, must do so based on a resolution of a council composed of the relevant administrator and physicians, dentists, pharmacists, nurses and other persons working in the relevant advanced treatment hospital, pursuant to an Order of the Ministry of Health, Labour and Welfare.
特定機能病院の管理者は、特定機能病院の管理及び運営に関する事項のうち重要なものとして厚生労働省令で定めるものを行う場合には、厚生労働省令で定めるところにより、当該管理者並びに当該特定機能病院に勤務する医師、歯科医師、薬剤師及び看護師その他の者をもつて構成する合議体の決議に基づいて行わなければならない。
The administrator of an advanced treatment hospital must make arrangements so that a medical care coordination system as provided for in Article 30-4, paragraph (2), item (ii) is properly constructed.
特定機能病院の管理者は、第三十条の四第二項第二号に規定する医療連携体制が適切に構築されるように配慮しなければならない。
第十六条の四
The administrator of a core hospital for clinical research, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must carry out the following particulars:
臨床研究中核病院の管理者は、厚生労働省令の定めるところにより、次に掲げる事項を行わなければならない。
to develop and implement a plan concerning specified clinical research;
特定臨床研究に関する計画を立案し、及び実施すること。
when conducting specified clinical research jointly with other hospitals or clinics, to play a leading role in the implementation of specified clinical research;
to provide consultation, necessary information, advice and other assistance to other hospitals or clinics concerning the implementation of specified clinical research;
to provide training on specified clinical research;
特定臨床研究に関する研修を行うこと。
to systematically manage the various records listed in items (iii) and (iv) of Article 22-3; and
第二十二条の三第三号及び第四号に掲げる諸記録を体系的に管理すること。
other particulars specified by an Order of the Ministry of Health, Labour and Welfare.
その他厚生労働省令で定める事項
第十七条
Beyond the provisions of Article 6-10 through Article 6-12, Article 13 through Article 14-2, Article 14-4, and Article 15 through the preceding Article, particulars that should be observed by the administrator of a hospital, clinic, or birthing center in the management of their buildings and equipment, pharmaceuticals, and other articles, and in the hospitalization or admission of patients, pregnant women, women in labor, and women resting after childbirth, are to be as prescribed by an Order of the Ministry of Health, Labour and Welfare.
第六条の十から第六条の十二まで、第十三条から第十四条の二まで、第十四条の四及び第十五条から前条までに定めるもののほか、病院、診療所又は助産所の管理者が、その構造設備、医薬品その他の物品の管理並びに患者、妊婦、産婦及びじよく婦の入院又は入所につき遵守すべき事項については、厚生労働省令で定める。
第十八条
The establisher of a hospital or clinic must provide an exclusive pharmacist in the relevant hospital or clinic in accordance with the standards specified by an Order of the Ministry of Health, Labour and Welfare and in accordance with Ordinances of the Prefecture (or, in the case of a clinic situated in a city or special ward with a public health center, the relevant city or special ward with a public health center); provided, however, that this does not apply where permitted by the prefectural governor of the area in which the hospital or clinic is situated.
第十九条
The establisher of a birthing center must provide for contract physicians and hospitals or clinics pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare.
When a midwife who only does house calls enters into a contract which provides that she will give midwifery services to a pregnant woman, etc., she must specify the hospital or clinic that responds to the abnormality of the relevant pregnant woman, etc., pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare.
第十九条の二
The establisher of an advanced treatment hospital, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must take the following measures to ensure that the administrator of the relevant advanced treatment hospital properly executes the management and operation of the relevant advanced treatment hospital:
特定機能病院の開設者は、当該特定機能病院の管理者による当該特定機能病院の管理及び運営に関する業務が適切に遂行されるよう、厚生労働省令で定めるところにより、次に掲げる措置を講じなければならない。
to clarify the authority that the relevant administrator has for the management and operation of the relevant advanced treatment hospital;
当該特定機能病院の管理及び運営について当該管理者が有する権限を明らかにすること。
to set up an audit committee for ensuring the safety of medical care.;
医療の安全の確保に関する監査委員会を設置すること。
to establish a system to ensure that the execution of the duties of the relevant administrator complies with laws and regulations, a system pertaining to the supervision of the business of the relevant advanced treatment hospital by the relevant establisher, and other systems specified by an Order of the Ministry of Health, Labour and Welfare as necessary to ensure the appropriateness of the business of the relevant advanced treatment hospital: and
当該管理者の業務の執行が法令に適合することを確保するための体制、当該開設者による当該特定機能病院の業務の監督に係る体制その他の当該特定機能病院の業務の適正を確保するために必要なものとして厚生労働省令で定める体制を整備すること。
other measures specified by an Order of the Ministry of Health, Labour and Welfare as necessary for the proper execution of the management and operation of the relevant advanced treatment hospital by the relevant administrator.
その他当該管理者による当該特定機能病院の管理及び運営に関する業務の適切な遂行に必要なものとして厚生労働省令で定める措置
第二十条
第二十一条
A hospital is to have the following personnel and facilities and must prepare the following records, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare (in the case of employees listed in item (i) (excluding physicians and dentists) and facilities listed in item (xii), Prefectural Ordinances):
beyond physicians, dentists in the numbers prescribed by an Order of the Ministry of Health, Labour and Welfare, nurses, and other employees in the numbers prescribed by prefectural ordinances, in accordance with the classifications of the beds at the relevant hospital;
a consultation room for each clinical department;
各科専門の診察室
an operating room;
手術室
treatment rooms;
処置室
a diagnostic laboratory;
臨床検査施設
an X-ray unit;
エックス線装置
a dispensary;
調剤所
food service facilities;
給食施設
records concerning medical treatment;
診療に関する諸記録
delivery rooms and neonatal bathing facilities in hospitals that have a gynecology and obstetrics department or an obstetrics department;
診療科名中に産婦人科又は産科を有する病院にあつては、分べん室及び新生児の入浴施設
functional training rooms in hospitals that have long-term care beds; and
other facilities as prescribed by prefectural ordinances.
その他都道府県の条例で定める施設
A clinic with long-term care beds must have the following personnel and facilities, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare (in the case of employees listed in item (i) (excluding physicians and dentists) and facilities listed in item (iii), Prefectural Ordinances):
beyond physicians, dentists in the numbers prescribed by an Order of the Ministry of Health, Labour and Welfare, nurses, and other employees, including those engaged in nursing support, in the numbers prescribed by Prefectural Ordinances;
厚生労働省令で定める員数の医師及び歯科医師のほか、都道府県の条例で定める員数の看護師及び看護の補助その他の業務の従業者
functional training rooms; and
機能訓練室
other facilities as prescribed by Prefectural Ordinances.
その他都道府県の条例で定める施設
When formulating the ordinances set forth in the preceding two paragraphs, prefectures is to determine the employees and the number of employees of hospitals and clinics with long-term care beds (limited to those specified by an Order of the Ministry of Health, Labour and Welfare) in accordance with the standards specified by an Order of the Ministry of Health, Labour and Welfare, and other particulars with reference to the standards specified by an Order of the Ministry of Health, Labour and Welfare.
第二十二条
Beyond the provisions of paragraph (1) of the preceding Article (excluding item (ix)), a regional medical care support hospital is to have the following facilities and must prepare the following records, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare:
an intensive care unit;
集中治療室
records concerning medical treatment;
診療に関する諸記録
chemical, bacteriological, and pathological inspection facilities;
化学、細菌及び病理の検査施設
an autopsy room;
病理解剖室
a laboratory;
研究室
a lecture room;
講義室
a library; and
図書室
other facilities as prescribed by an Order of the Ministry of Health, Labour and Welfare.
その他厚生労働省令で定める施設