Chapter I General Principles
Article 1 These Measures are formulated in accordance with the State Council's Regulations on the Administration of Medical Institutions (hereinafter referred to as the Regulations) and other relevant laws, rules and regulations, and in the light of the actual situation of this province, for the purpose of strengthening the administration of medical institutions and promoting the development of medical and healthcare undertakings.
Article 2 These Measures shall apply to the administrative region of the province engaged in disease diagnosis, treatment, rehabilitation activities of hospitals, sanatoriums, health centers, outpatient clinics, clinics, health stations, village health centers (rooms), nursing homes (stations), rehabilitation centers, first aid centers (stations), clinical testing centers, specialized disease prevention and treatment, maternal and child health care institutions, as well as other diagnostic and therapeutic institutions.
Article 3 of the health epidemic prevention, border health quarantine, medical research and teaching, medicine, family planning and other institutions outside the scope of business of the agency to carry out diagnostic and therapeutic activities, as well as cosmetic service institutions to carry out medical cosmetic services, should be based on the measures, apply for the establishment of the corresponding category of medical institutions.
Article 4 The People's Liberation Army and the People's Armed Police of China in Heilongjiang Province troops outside the establishment of medical institutions, by the municipal (local) health administrative departments in accordance with the Regulations and these Measures.
The competent agencies of Nongken and Sengan are responsible for the supervision and management of the medical institutions within the reclamation areas and Sengan forest areas, and are operationally subject to the supervision and guidance of the provincial health administrative departments.
Article 5 The health administrative departments at or above the county level are the competent departments of medical institutions, and are responsible for the supervision and management of medical institutions within the administrative area.
Public security, price, industry and commerce departments shall, within their respective spheres of competence, cooperate with the administrative department of health to do a good job in the supervision and management of medical institutions.
Chapter II set up approval
Article 6 of the county-level health administrative departments, shall be based on the national "medical institutions set up planning guidelines" to develop the administrative region "medical institutions set up planning" by the higher level of the health administrative department after examination and approval, reported to the people's government at the same level for approval, and integrated into the overall planning of social and economic development of the local government.
The province's unified planning and setting up of medical institutions, the provincial health administrative department to decide.
Article 7 The setting up of medical institutions shall be reported for approval in accordance with the following review authority:
(1) medical institutions without beds and first-level medical institutions by the county (district) health administrative department for review and approval of the municipal (district) health administrative department for review; county (district) health administrative department based on the municipal (district) health administrative department's approval of the applicant to make a decision whether or not to issue the "set up medical institutions approval letter The decision.
(2) the second level of medical institutions and local, municipal and county-level specialized prevention and treatment hospitals (institutes, stations), ninety-nine beds or less rehabilitation hospitals, two hundred and ninety-nine beds or less sanatoriums, as well as the county first aid station and other health care institutions by the municipal (local) health administrative department for approval, issued the "Approval of the Establishment of Medical Institutions," and then reported to the provincial health administrative department for the record.
(C) the third level of medical institutions and provincial-level specialized prevention and treatment hospitals (institutes, stations), more than one hundred beds of rehabilitation hospitals, more than three hundred beds of sanatoriums, municipal first aid centers, clinical testing centers and provincial health administrative departments directly under the medical institutions by the provincial health administrative departments for approval, issued by the "approval of the establishment of medical institutions.
Article VIII of the following circumstances, shall not apply for the establishment of medical institutions:
(1) the state shall not set up medical institutions in the circumstances;
(2) individuals in rural townships (towns), villages to set up medical institutions;
(3) the city (including counties) to set up the number of nonpublic health care institutions has exceeded the number of every 10,000 population to set up a health care institution
(4) the proposed establishment of non-public medical institutions less than one kilometer away from the public medical institutions, and the proposed diagnostic and therapeutic subjects and public medical institutions diagnostic and therapeutic subjects duplicated;
(5) the name of the medical institution does not comply with the provisions of the.
Article 9 Individuals applying to set up a clinic in a city shall also have the following conditions:
(1) Having obtained the Physician's Practice Certificate or obtained the title of Physician, they shall have been engaged in the clinical work of the same specialty for more than five years;
(2) They shall have a permanent residence in the locality.
Individuals applying to set up clinics in provincial municipalities shall, in addition to the above conditions, have the title of attending physician or above and have been engaged in clinical work of the same specialty for more than five years in a medical institution of the second level or above.
Article X. Individuals applying to set up nursing stations must obtain the "Chinese People's Republic of China **** and the State Nurse Practitioner Certificate" and be registered. Among them, the nurse should be engaged in clinical nursing work for more than five years; nurses should be engaged in clinical nursing work for more than ten years.
Article XI of the "set up a medical institution approval letter" is valid for three years for the third level of medical institutions; two years for the second level of medical institutions; medical institutions without beds and first level of medical institutions for one year. If the validity period is exceeded without declaring the registration of practice in accordance with the prescribed time limit, the Approval Letter for Establishment of Medical Institutions shall expire on its own from the date of expiration of the validity period.
Chapter III Registration of Practice
Article XII of the medical institutions in the completion of the "approval for the establishment of medical institutions" approved matters, shall apply for registration to the health administrative department at or above the county (district) level, to receive the "license for the practice of medical institutions".
Article 13 The application for registration of medical institutions shall fill out the "Application for Registration of Medical Institutions for Practice Registration", and submit relevant materials to the registration authority.
Article 14 The registration authority shall, after accepting an application for registration of a medical institution to practice medicine, within forty-five days, carry out an examination and on-site inspection and verification, and carry out on-site spot-check examination of the basic knowledge and skills of disinfection, isolation and aseptic operation on the relevant practitioners. If the review is qualified, the license to practice medicine shall be issued; if the review is not qualified, the applicant shall be notified in writing of the results of the review and the reasons for non-approval.
Article XV of the application for registration of medical institutions, one of the following circumstances, shall not be registered:
(1) the state shall not be registered in the circumstances;
(2) medical institutions and residents *** with the use of the same access road;
(3) does not have the conditions of specialties of the medical institutions to open oncology, psychiatric, infectious, tuberculosis, and other specialties;
(4) the medical institution shall be issued a license to practice medicine; the review will not be notified in writing of the reasons for the review and notification of the applicant. Section;
(d) individual midwifery clinics in cities (including counties).
Article 16 The establishment of medical institutions shall have the appropriate registered capital:
(1) medical institutions with more than 500 beds shall not be less than 10,000 yuan per bed;
(2) medical institutions with one hundred to four hundred and ninety-nine beds shall not be less than 6,000 yuan per bed;
(3) medical institutions with twenty to ninety-nine beds shall not be less than four thousand dollars per bed ;
(iv) Medical institutions without beds shall not be less than twenty thousand dollars.
Article XVII above the second level of medical institutions to set up branches, shall be to the proposed branch of the county (district) health administrative department for the establishment of the approval procedures, to the main hospital registration authority for registration of practice, obtain a license to practice. Branches should have the following conditions:
(a) hold the county-level health administrative department on the establishment of the branch of the approval;
(b) the legal representative should be the legal representative of the main hospital;
(c) health professionals should be the main hospital on staff, housing, equipment, funding should be provided by the main hospital;
(d) in line with the "Basic Standards for Medical Institutions".
Article XVIII of the medical institutions to change the name, address, form of ownership, service recipients, persons in charge, diagnostic and therapeutic subjects, beds (dental chairs) shall be registered with the original registration authority for change.
Article 19 of the medical institutions for any reason more than seven days within thirty days of closure, shall be reported in writing to the original registration authority, explain the reasons for approval procedures; closure of more than thirty days within one year, in addition to the approval procedures, should be temporarily surrendered to the "license to practice in the medical institutions; closure of more than one year, shall be registered with the original registration authority for deregistration. Re-opening shall re-apply for approval of the establishment.
Article 20 of the second level of medical institutions above the verification period of three years; do not have beds in the medical institutions and first-class medical institutions of the verification period of one year.
Article 21 A medical institution shall, three months before the expiration of the validation period, apply to the registration authority for validation procedures and submit the following documents:
(1) documents that should be submitted in accordance with the state regulations;
(2) the certificate of accreditation of the medical institution;
(3) the annual report on the work of the medical institution during the validation period;
(4) medical institutions Report on the implementation of the system of continuing medical education for health care technicians.
Article 22 When a medical institution goes to the registration authority for the verification procedure, the registration authority will grant a one- to six-month suspension of the verification period if one of the following circumstances applies:
(1) it fails to comply with the "Basic Standards for Medical Institutions";
(2) it is in the period of time for rectification or during the period of closure for rectification;
(3) it fails to be accredited or fails to take part in the accreditation without prior approval;
(4) it has to submit a report on the annual work of medical institutions; and
(4) use of unauthorized or not allowed to continue to use the diagnostic and treatment techniques and methods;
(5) failure to pay the required fees on time;
(6) the occurrence of medical liability accidents of Grade 2 or above has not been properly handled.
The registration authority shall cancel the License to Practice in Medical Institutions of a medical institution if it still fails to pass the verification upon the expiration of the deferred verification period. Medical institutions without beds may not practice during the period of deferred verification.
Article 23 of the "medical institutions license" is valid for five years for medical institutions without beds and first-class medical institutions; second-class or higher medical institutions for ten years.
Article 24 The License to Practice in Medical Institutions shall not be forged, altered, sold, transferred or lent. Lost license shall be lost or should have known of the loss of three days from the date of report to the original registration authority and apply for reissue.
Article 25 The opening of medical institutions, relocation, name change, change of diagnostic and therapeutic subjects, as well as the results of the closure of business, business closure, the results of the inspection by the registration authority shall be announced, the announcement fee shall be borne by the medical institution.
Article 26 The name of the medical institution by the identification of the name and common name in turn.
The name of a medical institution shall not be traded or lent. The name of a medical institution may not be transferred without the permission of the approving authority.
Article 27 The names of medical institutions shall conform to the principles of naming prescribed by the state.
Containing "Heilongjiang", "the province", "province", "Northeast" and other words As well as across the region, the city name, "Center" as the common name of the medical institution, in the identification of the name contains the word "Center", approved by the provincial health administrative department.
Containing foreign countries (regions), international organizations and "China", "national", "China", "national" and so on. "and other names, should be reviewed by the provincial health administrative department, reported to the State Council health administrative department for approval.
The "Red Cross" as a medical institution to identify the name, should be signed by the provincial Red Cross and reported to the provincial health administrative department for the record.
Article 28 of the name of the medical institutions registered by the approval authority before use, within the approved scope of the exclusive right.
The plaque of the medical institution shall be standardized. The format of writing shall highlight the main body.
Chapter IV Practice
Article 29 Medical institutions shall strictly implement aseptic disinfection, isolation system, and take scientific and effective measures to deal with sewage and waste, and to prevent and reduce hospital-acquired infections.
Medical institutions shall not carry out injection and infusion business without sterilization equipment or personnel with the title of nurse or above.
Article 30 of the medical institutions for outpatients and hospitalized patients shall establish a complete medical records. Outpatient outpatient more than fifteen years no longer come to the hospital, the case can be registered off the shelf destroyed. Inpatient case retention period shall not be less than thirty years, special cases should be kept permanently. Outpatient and inpatient case cover should be standardized.
Article 31 of the medical institutions shall strictly implement the provincial health administrative departments to develop or recognized with the diagnosis and treatment activities related to technical standards, operating procedures, and often on the medical staff to carry out the "basic theory, basic knowledge, basic skills" training and assessment to ensure medical safety.
Article 32 without a physician (doctor) personally examine the patient, medical institutions shall not issue a diagnosis of disease, health certificates or death medical certificate report and other documents; without a physician (doctor), midwives personally delivery, medical institutions shall not issue birth certificates or stillbirth certificates.
Article 33 Medical institutions shall not use medical technology to identify the sex of the fetus. If necessary for scientific research or diagnosis of hereditary diseases, it shall be approved by the original registration authority.
To engage in artificial insemination technology research or organ transplantation, shall be approved by the provincial health administrative department before proceeding.
Article 34 Medical institutions shall not use counterfeit or shoddy medicines, expired and invalid medicines and prohibited medicines.
Medical institutions shall not use unapproved disinfectant medicines and disposable medical and health supplies.
Article 35 The medical institutions shall do the fixed license to practice medicine, according to the approved scope of registered subjects to carry out diagnostic and treatment activities, and charge fees in accordance with the relevant provisions.
It is strictly prohibited for medical personnel to take advantage of their positions to solicit money or property from patients or their families, and to receive kickback fees for referrals or examinations.
Article 36 of the outpatient clinics, clinics, health centers, infirmaries, health care centers, health stations should be in accordance with the diagnosis and treatment subjects, the scope of services attached to the pharmacy (cabinet). The types of drugs are approved by the registration authority, and issued "with a drug license". Non-public clinics can only be accompanied by a certain number of common diseases and critical illnesses and rescue medicines: Western medicine clinics can only be accompanied by Western medicine and shall not exceed forty; Chinese medicine clinics can only be accompanied by Chinese medicine, its proprietary Chinese medicines shall not exceed thirty, not more than two hundred kinds of tablets. Acupuncture, massage, dental veneers, medical consultation and other services are not allowed to bring drugs.
Article 37: Clinics, health centers, dispensaries, health care centers and health stations shall not carry out family-planning surgeries, and shall not engage in the business of delivering babies or treating sexually transmitted diseases without authorization
.
Article 38 Medical institutions may not use non-health technicians to engage in medical and health technology. Without the approval of the registration authority, one may not take on an apprentice to practice medicine.
Retired health technicians of public medical institutions may only practice in one medical institution and may not be employed in more than one place.
Article 39 of the medical institutions to introduce foreign medical institutions, new technologies, new projects and technical cooperation, shall be examined and approved by the registration authority.
Article 40 A medical institution shall not lease or contract its medical premises to medical personnel or non-health technicians other than those of the institution to operate, and shall not use improper means to entice the public to seek medical treatment.
Article 41 Medical institutions shall, in accordance with the relevant laws, rules and regulations, undertake community primary health care, support for rural areas, and guidance to the grassroots and other health tasks. In the event of major disasters, disease epidemics and other emergencies, must obey the command of the health administrative department.
Article 42 Medical institutions publishing, broadcasting, posting medical advertisements, shall hold the "medical advertisement certificate" issued by the administrative department of health, and in accordance with the "Measures for the Administration of Medical Advertisements" relevant provisions of the formalities.
Chapter V Supervision and Management
Article 43 The administrative departments of health at or above the county level shall exercise supervision and management over the medical institutions in the areas under their jurisdiction.
Superior health administrative departments have the right to supervise and inspect the supervision and management of medical institutions of lower-level health administrative departments of law enforcement, and in accordance with the law to correct its violation of the "Regulations" and the decisions made by this method, the various types of medical institutions within the jurisdiction of the practice of direct inspection and supervision.
Article 44 above the county level health administrative department of medical institutions supervisors by the same level of health administrative department appointed and managed.
Supervisors of medical institutions shall, in the performance of their duties, wear and show the signs and documents of supervisors of medical institutions supervised by the Ministry of Health and the Administrative Law Enforcement Certificate issued by the people's governments at or above the county level.
Article 45 The administrative departments of health at or above the county level shall set up evaluation committees of medical institutions composed of experts to conduct comprehensive evaluations of the quality of service, technical level and management level of medical institutions.
Chapter VI Penalties
Article 46 Violation of these measures, without obtaining the "medical institutions practice permit" to practice, by the health administrative departments above the county level shall order them to stop practicing, confiscate the illegal income and drugs, equipment, and impose a fine of more than 300 yuan to less than three thousand yuan. In one of the following cases, it shall be ordered to stop practicing, confiscate the illegal gains and medicines and devices, and impose a fine of not less than three thousand yuan and not more than ten thousand yuan:
(a) unauthorized practice has been punished by the administrative department of health;
(b) unauthorized practice of non-health technicians;
(c) unauthorized practice of more than three months;
(d) unauthorized practice of more than three months;
(e) unauthorized practice of the health administration department;
(f) unauthorized practice of the health administration department;
(D) medical institutions serving internal workers without the required change of registration to the community;
(E) medical institutions without change of registration to change the practice of registration matters;
(F) itinerant practice of medicine, market stalls practice of medicine and the practice of medicine with a fake license.
Article 47 violation of these measures, not in accordance with the provisions of the verification of the "medical institutions license", and does not stop the diagnosis and treatment activities, by the health administrative department above the county level and ordered to make up for the verification procedures; overdue, the revocation of its "medical institutions license".
Article 48 violation of these measures, the transfer, lending "medical institutions license", by the health administrative department above the county level, confiscate the illegal income, and impose a fine of three hundred yuan or more than three thousand yuan. In any of the following cases, the illegal gains shall be confiscated, and a fine of not less than three thousand yuan and not more than five thousand yuan shall be imposed, and the License to Practice in Medical Institutions shall be revoked:
(1) leasing or contracting of medical premises to medical personnel outside the medical institution or to a non-health technician for operation;
(2) selling, lending, transferring of medical instruments and documents of the medical institution, as well as fraudulent use of medical instruments and documents of other medical institutions. Medical institutions, medical instruments, documents.
Article 49 In addition to emergency and first aid, medical institutions, diagnostic and treatment activities beyond the scope of registration, the circumstances are minor, by the health administrative department at or above the county level shall be warned; one of the following circumstances, shall be ordered to make corrections within a certain period of time, until the revocation of its <
(A) unauthorized family planning surgery, midwifery and treatment of sexually transmitted diseases business;
(B) unauthorized fetal sex identification or engaged in artificial insemination, organ transplantation;
(C) equipped with the types of drugs in excess of the provisions of the scope of the carry drugs.
Article 50 Violation of these Measures, the employment of non-health technicians, in-service health technicians and retired personnel not in accordance with the provisions of the external formalities for medical and health technology work, by the health administrative department at or above the county level ordered to make corrections within a certain period of time, and impose a fine of three hundred yuan or more than three thousand yuan or less.
The use of health care institutions to engage in diagnostic and treatment activities other than their own specialties, according to the use of non-health care personnel.
Article 51 violation of these measures, the issuance of false documents, the circumstances are minor, by the health administrative department at or above the county level to give a warning, and may be fined less than five hundred yuan; to the patient's mental health, causing delay in diagnosis and treatment, and other harmful consequences, shall be sentenced to a fine of five hundred yuan or more than one thousand yuan;
The personnel directly responsible for the unit or a higher-level The organ to give administrative sanctions, and impose a fine of two hundred yuan or more than one thousand yuan.
Article 52 violation of these Measures, medical institutions, medical personnel to take advantage of their duties, to the patient or his family members to ask for money, receive referrals or examination and other kickbacks, the unit where it is found to be true, by the health administrative department at or above the county level to the directly responsible person, a fine of five times the amount received, up to a maximum of 50,000 yuan. The main person in charge of the medical institution that is not seriously investigated and verified, shall be subject to administrative sanctions.
Article 53 Violation of these measures, the unauthorized use of narcotic drugs, toxic drugs, radioactive drugs and biological products or the sale and use of counterfeit drugs, substandard drugs, in addition to the "Chinese People's Republic of China *** and the State Drug Administration Law" relevant provisions of the treatment, by the health administrative department at or above the county level, the revocation of its "medical institutions license".
Article 54 If a medical institution has any of the following circumstances, the registration authority may order it to make corrections within a certain period of time:
(1) the relevant circumstances stipulated by the state;
(2) the occurrence of a liability accident of grade two or above, or other major accidents that have not been dealt with appropriately;
(3) the failure to implement the tasks of primary health care.
Article 55 Medical institutions and advertising units broadcasting medical advertisements that have not been examined and approved, shall be investigated and dealt with by the administrative departments for health and industry and commerce at or above the county level in accordance with their respective responsibilities.
Medical institutions that engage in price violations shall be dealt with by the price department in accordance with relevant laws and regulations.
Article 56 violation of these measures, the circumstances are serious, constituting a crime, shall be investigated for criminal responsibility.
Article 57 The administrative departments of health at all levels in the implementation of administrative penalties, shall be in accordance with the "Chinese People's *** and the State Administrative Penalty Law" statutory procedures.
Article 58 If the parties concerned are not satisfied with the decision on administrative penalty, they may apply for reconsideration or bring an administrative lawsuit in accordance with the "Administrative Reconsideration Law of the People's Republic of China*** and the State" and the "Administrative Litigation Law of the People's Republic of China*** and the State".
If an application for reconsideration or a lawsuit is not filed after the expiration of the time limit, and if the administrative penalty decision is not fulfilled, the organ that has made the administrative penalty decision may apply to the people's court for compulsory execution.
Chapter VII Supplementary Provisions
Article 59 These Measures shall come into force on February 1, 1997. Provincial People's Government issued by the Hei Zheng Fa [1986] No. 19 "Heilongjiang Province, individual and joint medical institutions management measures" shall be repealed at the same time.