Article 1
These regulations are formulated in order to strengthen the management of medical institutions, promote the development of medical and health care, and protect the health of citizens.
Article 2
These regulations apply to medical institutions such as hospitals, health centers, sanatoriums, outpatient clinics, clinics, health centers (rooms), and first-aid stations, etc., engaged in the activities of diagnosis and treatment of diseases.
Article 3
Medical institutions aim at saving lives, preventing and treating diseases, and serving the health of citizens.
Article 4
The State supports the development of medical institutions and encourages the establishment of medical institutions in various forms.
Article 5
The health administrative department of the State Council is responsible for the supervision and management of medical institutions throughout the country.
The health administrative departments of the local people's governments at or above the county level are responsible for the supervision and management of medical institutions in their own administrative areas.
The competent health department of the Chinese People's Liberation Army (PLA) is responsible for the supervision and management of the medical institutions of the army in accordance with these regulations and the relevant provisions of the State.
Planning Approval
Article 6
The health administrative departments of the local people's governments at or above the county level shall, in accordance with the population, medical resources, medical needs and the distribution of the existing medical institutions in the administrative area, formulate a plan for the establishment of medical institutions in the administrative area.
Organs, enterprises and institutions can set up medical institutions in accordance with the needs, and included in the local medical institutions set up planning.
Article 7
Local people's governments at or above the county level shall incorporate the planning for the setting up of medical institutions into the local regional health development plan and the overall plan for urban and rural construction development.
Article 8
The setting up of medical institutions shall be in accordance with the planning for the setting up of medical institutions and the basic standards for medical institutions.
Basic standards for medical institutions by the State Council administrative department of health.
Article 9
Units or individuals setting up medical institutions must be examined and approved by the health administrative department of the local people's government at or above the county level and obtain approval for the setting up of medical institutions before they can apply for other formalities with the relevant departments.
Article 10
Applications for setting up medical institutions shall be submitted with the following documents:
(1) application for setting up;
(2) report on feasibility study of setting up;
(3) report on site selection and architectural design plan.
Article 11
Units or individuals setting up medical institutions shall apply for setting up in accordance with the following provisions:
(1) medical institutions without beds or with less than 100 beds shall apply to the administrative department of health of the people's government at the county level of the place where they are situated;
(2) medical institutions with more than 100 beds and specialized hospitals shall apply for setting up in accordance with the provisions of the administrative department of health of the people's government at the provincial level. People's Government administrative department of health to apply.
Article 12
The health administrative department of the local people's government at or above the county level shall, within 30 days from the date of acceptance of the application for setting up, give a written reply of approval or disapproval; where approval is given for the setting up, a certificate of approval for the setting up of the medical institution shall be issued.
Article 13
The setting up of medical institutions under national unified planning shall be decided by the health administrative department of the State Council.
Article 14
Organs, enterprises and institutions in accordance with the basic standards of the national medical institutions set up outpatient clinics, clinics, health clinics (rooms) for the internal staff services, reported to the health administrative department of the people's government of the county in which it is located for the record.
Registration
Article 15
Medical institutions to practice, must be registered to receive the "license to practice medical institutions".
Article 16
Applicants for the registration of medical institutions to practice medicine shall have the following conditions:
(1) a certificate of approval for the establishment of a medical institution;
(2) compliance with the basic standards of a medical institution;
(3) a suitable name, organization and premises;
(4) funds appropriate to the business they carry out , facilities, equipment and professional health technicians;
(v) have appropriate rules and regulations;
(vi) be able to independently assume civil liability.
Article 17
The registration of the practice of medical institutions shall be handled by the administrative department of health of the people's government that approves its establishment.
The registration of practice of medical institutions set up in accordance with the provisions of Article 13 of these Regulations shall be handled by the administrative department of health of the people's government of the province, autonomous region or municipality directly under the central government where it is located.
Organs, enterprises and institutions set up for internal staff services clinics, clinics, health centers (rooms) of the practice of registration by the county-level people's government of the local health administrative department.
Article 18
The main matters for the registration of medical institutions:
(1) name, address, the main person in charge;
(2) the form of ownership;
(3) diagnostic and therapeutic subjects, beds;
(4) registered capital.
Article 19
The health administrative department of the local people's government at or above the county level shall, within 45 days from the date of acceptance of the application for registration of practice, conduct an examination and approval in accordance with these Regulations and the basic standards for medical institutions. If the audit is qualified, it shall be registered and issued a "license to practice medicine"; if the audit is not qualified, the applicant shall be notified in writing of the results of the audit.
Article 20
Medical institutions that change their name, place, principal person in charge, diagnostic and therapeutic subjects, beds, must register the change with the original registration authority.
Article 21
Medical institutions out of business, must be registered with the original registration authority for cancellation. Approved by the registration authority, the collection of "medical institutions license".
Medical institutions are considered to be out of business if they have been closed for more than one year for reasons other than alteration, expansion or relocation.
Article 22
Bed less than 100 medical institutions, its "medical practice permit" once a year verification; beds in more than 100 medical institutions, its "medical practice permit" once every three years verification. The verification is handled by the original registration authority.
Article 23
The License to Practice in Medical Institutions shall not be forged, altered, sold, transferred or lent.
If the License to Practice in a Medical Institution is lost, it shall be promptly affirmed and an application for reissue shall be made to the original registration authority.
Practice
Article 24
No unit or individual shall carry out diagnostic or therapeutic activities without obtaining a License to Practice in a Medical Institution.
Article 25
Medical institutions practice, must comply with the relevant laws, regulations and medical technical specifications.
Article 26
Medical institutions must be "medical practice license", the subjects of treatment, treatment time and fees hanging in obvious places.
Article 27
Medical institutions must be registered in accordance with the approved diagnostic and therapeutic subjects to carry out diagnostic and therapeutic activities.
Article 28
Medical institutions shall not use non-health professionals to engage in medical and health technology.
Article 29
Medical institutions shall strengthen the education of medical personnel in medical ethics.
Article 30
The staff of a medical institution must wear a tag containing their name, position or title when they go to work.
Article 31
Medical institutions shall immediately rescue critically ill patients. Limited to the equipment or technical conditions can not diagnosis and treatment of patients, shall be promptly referred.
Article 32
Without a physician (doctor) to personally examine the patient, medical institutions shall not issue a diagnosis of disease, health certificate or death certificate and other supporting documents; without a physician (doctor), midwife personally delivery, medical institutions shall not issue a birth certificate or stillbirth report.
Article 33
When a medical institution performs an operation, special examination or special treatment, it must obtain the consent of the patient, and shall obtain the consent and signature of his or her family members or relations; if it is impossible to obtain the patient's opinion, it shall obtain the consent and signature of his or her family members or relations; if it is impossible to obtain the patient's opinion and there are no family members or relations present, or in the event of any other special circumstance, the physician who has undergone treatment shall propose a medical disposal plan. The physician shall propose medical treatment plan, after obtaining the approval of the head of the medical institution or authorized personnel responsible for the implementation.
Article 34
Medical malpractice in a medical institution shall be handled in accordance with the relevant provisions of the State.
Article 35
Medical institutions shall handle special diagnosis and treatment of patients with infectious diseases, mental illnesses and occupational diseases in accordance with the provisions of the relevant state laws and regulations.
Article 36
Medical institutions must strengthen the management of drugs in accordance with the relevant laws and regulations on drug management.
Article 37
Medical institutions must collect medical fees in accordance with the relevant provisions of the People's Government or the price department, detailing the items and issuing receipts.
Article 38
Medical institutions must undertake the appropriate preventive health care, undertake the people's governments at or above the county level health administrative department entrusted with supporting rural areas, guiding the work of grass-roots health care and other tasks.
Article 39
In the event of major disasters, accidents, disease epidemics, or other unforeseen circumstances, medical institutions and their health technicians must obey the deployment of the administrative departments of health of the people's governments at or above the county level
Supervision and management
Article 40
The administrative departments of health of the people's governments at or above the county level shall exercise the following supervisory and management powers and functions:
(1) to be responsible for the approval of the setting up of medical institutions, registration of practice and verification;
(2) to carry out inspection and guidance of the practice of medical institutions;
(3) to be responsible for organizing the accreditation of medical institutions;
(4) to impose penalties for violations of these regulations.
Article 41
The State implements an accreditation system for medical institutions, whereby an accreditation committee composed of experts conducts a comprehensive evaluation of the practice and quality of medical services of a medical institution in accordance with the methods for accrediting medical institutions and the accreditation standards.
Methods and standards for accreditation of medical institutions shall be formulated by the health administrative department of the State Council.
Article 42
The health administrative departments of the local people's governments at or above the county level are responsible for organizing the evaluation committees of the medical institutions in their administrative regions.
The accreditation committee of medical institutions consists of experts in hospital management, medical education, medical, medical technology, nursing and finance. Accreditation committee members are appointed by the local people's government at or above the county level health administrative department.
Article 43
According to the evaluation of the local people's government at or above the county level, the health administrative department of the evaluation committee, to meet the accreditation standards of the medical institutions, issued by the accreditation of the certificate of conformity; not meet the accreditation standards of the medical institutions, the proposed treatment of opinions.
Penalties
Article 44
In violation of the provisions of Article 24 of these Regulations, if a medical institution practices without obtaining a Medical Institution Practice Permit, the administrative department of health of the people's government at or above the county level shall order it to cease its practice, confiscate its illegal gains and medicines and instruments, and may impose a fine of not more than 10,000 yuan according to the circumstances.
Article 45
In violation of the provisions of Article 22 of these Regulations, overdue verification of the "medical institutions practice permit" is still engaged in diagnostic and therapeutic activities, by the people's governments at or above the county level administrative department of health ordered to make up for the verification of the formalities within a certain period of time; refusal to verify, revocation of its "medical institutions practice permit".
Article 46
In violation of the provisions of Article 23 of these Regulations, selling, transferring, lending "medical institutions practice permit", by the people's governments at or above the county level, the administrative department of health confiscate the illegal income, and may be fined less than 5,000 yuan; the circumstances are serious, the revocation of its "medical institutions practice permit".
Article 47
In violation of the provisions of Article 27 of these Regulations, the diagnostic and therapeutic activities exceed the scope of registration, the health administrative department of the people's government at or above the county level shall give a warning, order it to make corrections, and may impose a fine of up to 3,000 yuan according to the circumstances; if the circumstances are serious, the revocation of its "license to practice as a healthcare institution".
Article 48
In violation of the provisions of Article 28 of these Regulations, the use of non-health technicians to engage in medical and health technology, the health administrative department of the people's government at or above the county level shall order it to make corrections within a certain period of time and may impose a fine of up to 5,000 yuan; if the circumstances are serious, the revocation of its "license to practice in a health care institution".
Article 49
In violation of the provisions of Article 32 of these Regulations, the issuance of false certificates, the health administrative department of the people's government at or above the county level shall issue a warning; if it causes harm, it may be fined not more than 1,000 yuan; and the directly responsible personnel shall be given administrative sanctions by their units or higher authorities.
Article 50
All confiscated property and fines shall be turned over to the State Treasury.
Article 51
If the party concerned is not satisfied with the decision on the administrative penalty, it may apply for administrative reconsideration or file an administrative lawsuit in accordance with the provisions of national laws and regulations. The parties to the fines and confiscation of drugs and equipment of the penalty decision did not apply for reconsideration or litigation within the statutory period and does not fulfill, the people's government at or above the county level administrative department of health may apply to the people's court for compulsory execution.
Attachment
Article 52
Medical institutions that have been practicing before the implementation of these Regulations shall, within six months after the implementation of the Regulations, complete the registration procedures and receive the License for Practice of Medical Institutions in accordance with the provisions of Chapter III of these Regulations.
Article 53
Methods for the administration of medical institutions opened by foreigners within the territory of the People's Republic of China*** and the People's Republic of China and for the opening of medical institutions by residents of Hong Kong, Macao, and Taiwan on the mainland, shall be formulated separately by the health administrative department of the State Council.
Article 54
These Regulations shall be interpreted by the health administrative department of the State Council.
Article 55
These Regulations shall come into force on September 1, 1994, and the Provisional Regulations on the Administration of Hospitals and Clinics approved and issued by the State Council in 1951 shall be repealed at the same time.