Chapter 2 Chinese medical institutions and practitioners
Article 8 of the opening of Chinese medicine medical institutions, should be consistent with the State Council's health administrative department of the establishment of Chinese medicine medical institution standards and local regional health planning, and in accordance with the "Regulations on the Management of Medical Institutions" for approval procedures, to obtain the license to practice in a medical institution, then can engage in medical activities. Only after obtaining a license to practice medical institutions can they engage in traditional Chinese medical activities.
Article 9 Chinese medicine medical institutions engaged in medical service activities shall give full play to the characteristics and advantages of Chinese medicine, follow the laws of the development of Chinese medicine itself, apply traditional theories and methods, combined with modern scientific and technological means, and give full play to the role of traditional Chinese medicine in the prevention and treatment of diseases, health care, and rehabilitation, and provide the public with reasonably priced, high-quality Chinese medicine services.
Article X. Community health service centers (stations), township health centers and other urban and rural grass-roots health service institutions established in accordance with the law shall be able to provide Chinese medicine medical services.
Article XI practitioners of traditional Chinese medicine shall, in accordance with the laws, administrative regulations and departmental rules relating to the management of health through the qualification examination, and registered to obtain a practicing certificate before engaging in traditional Chinese medicine service activities.
To learn Chinese medicine in the form of teacher training, as well as people with expertise, shall, in accordance with the provisions of the State Council administrative department of health, through the licensed physician or physician assistant qualification examination, and after registration to obtain a certificate of practice of traditional Chinese medicine, before engaging in medical activities.
Article XII practitioners of traditional Chinese medicine shall comply with the corresponding principles of diagnosis and treatment of traditional Chinese medicine, medical technology standards and technical operation norms.
General practitioners and rural doctors shall have basic knowledge of traditional Chinese medicine and basic skills in the use of traditional Chinese medicine diagnostic and therapeutic knowledge and techniques to deal with common and frequent diseases.
Article XIII of the release of Chinese medicine medical advertisements, medical institutions shall, in accordance with the provisions of the local people's governments of provinces, autonomous regions and municipalities directly under the Central People's Government in charge of the administration of traditional Chinese medicine department to apply for and submit the relevant materials. Provinces, autonomous regions, municipalities directly under the Central People's Government responsible for the administration of traditional Chinese medicine shall, within 10 working days from the date of receipt of the relevant materials for review, and make a decision on whether to issue the approval number of Chinese medicine advertisements. To meet the prescribed requirements, issued by the Chinese medical advertising approval number. Without the approval number of Chinese medical advertisements, shall not publish Chinese medical advertisements.
The contents of the published Chinese medical advertisements shall be consistent with the contents of the review and approval of the publication.
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Medical Institutions Regulations Enforcement Rules
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Chapter I General Provisions
Article 1 These rules are formulated in accordance with the Regulations on the Administration of Medical Institutions (hereinafter referred to as the Regulations).
The second regulation and the rules referred to in the medical institutions, is based on the provisions of the regulations and the rules, the registration of medical institutions to obtain a "medical practice license".
Article 3 Categories of Medical Institutions:
(1) General Hospitals, Chinese Medicine Hospitals, Hospitals Combining Traditional and Western Medicine, Ethnomedicine Hospitals, Specialized Hospitals, and Rehabilitation Hospitals;
(2) Maternity and Child Healthcare Hospitals;
(3) Central Health Centers, Township Health Centers, and Neighborhood Health Centers;
(4) Convalescent Centers;
(5) Comprehensive Outpatient Departments, Specialized Outpatient Departments and Specialized Health Centers;
() (v) comprehensive outpatient clinics, specialized outpatient clinics, Chinese medicine outpatient clinics, combined Chinese and Western medicine outpatient clinics, ethnic medicine outpatient clinics;
(vi) clinics, Chinese medicine clinics, ethnic medicine clinics, health clinics, dispensaries, health care clinics, health stations;
(vii) village health clinics;
(viii) first-aid centers, first-aid stations;
(ix) clinical test Center;
(j) Specialized disease prevention and treatment hospitals, specialized disease prevention and treatment institutes, specialized disease prevention and treatment stations;
(k) Nursing homes, nursing stations;
(l) Other diagnostic and treatment institutions.
Article IV of the health epidemiological, border health quarantine, medical research and teaching institutions outside the scope of business of the institution to carry out diagnostic and treatment activities as well as cosmetic service organizations to carry out medical cosmetic services, must be based on the Regulations and the Rules, apply for the establishment of the appropriate category of medical institutions.
Article 5 Medical institutions outside the establishment of the Chinese People's Liberation Army and the Chinese People's Armed Police Force shall be managed by the local health administrative departments in accordance with the Regulations and these Rules.
The competent department of logistics and health of the Chinese People's Liberation Army is responsible for providing the local health administrative departments with the names and addresses of medical institutions outside the establishment of the army.
Article 6 Medical institutions engaged in diagnostic and therapeutic activities in accordance with the law shall be protected by law.
Article 7 The administrative department of health shall independently exercise supervisory and management authority in accordance with law. Not subject to any unit or individual interference.
Chapter II Approval of Establishment
Article 8 Provinces, autonomous regions and municipalities directly under the Central Government shall rationally allocate and rationally utilize medical resources in accordance with the local Medical Institution Establishment Plan.
The "Medical Institution Establishment Plan" shall be formulated by the local health administrative departments at or above the county level on the basis of the "Guiding Principles for Medical Institution Establishment Planning", reviewed and approved by the health administrative departments of the next higher level, and reported to the people's government at the same level for approval, and then issued and implemented within the administrative region.
The Guiding Principles for the Planning of Medical Institution Settings are formulated separately.
Article 9: The local health administrative departments at or above the county level shall, in accordance with the authority and procedures set forth in the Guiding Principles for the Establishment of Medical Institutions Planning, organize the implementation of the Medical Institutions Establishment Planning in their respective administrative areas, evaluate the implementation on a regular basis, and report the results of the evaluations on an annual basis to the higher-level health administrative departments and the people's government at the same level.
Article X. Medical institutions, regardless of category, form of ownership, affiliation, service recipients, the establishment of which must be in line with the local "Medical Institutions Establishment Plan.
Article XI beds in more than 100 general hospitals, hospitals of traditional Chinese medicine, Chinese and Western medicine hospitals, hospitals of ethnic medicine, as well as specialty hospitals, sanatoriums, rehabilitation hospitals, maternity and child health hospitals, first aid centers, clinical testing centers, and specialty disease prevention and treatment institutions set up the division of authority by the provinces, autonomous regions and municipalities directly under the central health administrative departments; the setting up of other health care institutions, by the county-level health Administrative departments at the county level for approval.
Article 12 No application shall be made for the establishment of a medical institution under any of the following circumstances:
(1) a unit which is unable to bear civil responsibility independently;
(2) an individual who is serving a sentence of imprisonment or who does not have the capacity for full civil conduct;
(3) a medical institution in which a medical staff member is on duty, retired from his post due to illness, or suspended without pay;
(4) an individual who has been in medical trouble for less than five years. Medical personnel who have been involved in medical accidents of Grade 2 or above for less than five years;
(e) Medical personnel whose practicing certificates have been revoked due to violation of relevant laws, rules and regulations;
(f) Legal representatives or persons in charge of medical institutions whose practicing licenses have been revoked;
(g) Provincial, autonomous regions and municipalities directly under the central government health administrative departments. Other circumstances.
In the preceding paragraph (b), (c), (d), (e), (f) one of the circumstances listed, shall not act as the legal representative of the medical institution or the person in charge.
Article XIII in the city to set up clinics for individuals, must also have the following conditions:
(a) by the physician practice technical examination, to obtain the "physician's license";
(b) to obtain the "physician's license" or physician's title, engaged in the same profession for more than five years in the clinical work;
(c) the provinces, autonomous regions, municipalities directly under the Central Government Other conditions prescribed by the administrative department of health.
Technical standards for physician practice are formulated separately.
The conditions for individuals setting up clinics in townships and villages shall be prescribed by the health administrative departments of the provinces, autonomous regions and municipalities directly under the central government.
Article 14 Local people's governments at all levels to set up medical institutions, the government designated or appointed by the proposed medical institution in charge of the preparation of the application; a legal person or other organization to set up a medical institution, the application by its representative; individuals to set up a medical institution, by the establishment of the person to apply for; more than two people to set up a medical institution, by the partners **** with the application.
Article 15 The feasibility study report on the establishment of a medical institution submitted in accordance with Article 10 of the Regulations shall include the following contents:
(1) the name of the applicant, the basic situation and the applicant's name, age, professional history and identity card number;
(2) the general situation of the demographic, economic and social development of the region in which it is located;
(3) the health of the population and the prevalence of diseases as well as the prevalence of the diseases concerned in the region; and (4) the health status of the population in the region in which it is located. Disease prevalence and the prevalence of the disease concerned;
(iv) Distribution of medical resources in the region and analysis of the demand for medical services;
(v) The name, location, functions, tasks and service radius of the proposed medical institution;
(vi) Mode and time of service, diagnostic and therapeutic subjects, and the bed establishment of the proposed medical institution;
(vii) The organizational structure, staffing of the proposed medical institution;
(viii) The proposed (viii) The organizational structure and staffing of the proposed medical institution;
(viii) The instrumentation and equipment of the proposed medical institution;
(ix) The relationship between the proposed medical institution and other medical institutions within the service radius area and its impact;
(x) The sewage, filth, and fecal matter treatment plan of the proposed medical institution;
(xi) The communication, power supply, sewerage, and fire fighting facilities of the proposed medical institution
(xii) the source of funds, investment methods, total investment, registered capital (capital);
(xiii) the proposed medical institution's investment budget;
(xiv) the proposed medical institution's five-year cost-benefit forecast and analysis.
Attached to the application for the design unit or set up the person's credentials.
Applications for the establishment of outpatient clinics, clinics, health centers, medical clinics, health clinics, health stations, village health clinics (offices), nursing stations and other medical institutions can be appropriately simplified according to the circumstances of the establishment of the feasibility study report content.
Article 16 The site selection report submitted in accordance with the provisions of Article 10 of the Regulations shall include the following contents:
(1) the basis for the site selection;
(2) the environment and utilities in the area where the site is located;
(3) the relationship between the site selection and the surrounding layout of child care institutions, primary and secondary schools, food production and operation units;
(4) the area occupied by the and building area.
Article 17 If two or more legal persons or other organizations*** apply for the establishment of a medical institution, or if two or more persons apply for the establishment of a medical institution in partnership, in addition to submitting a feasibility study report and a site selection report, they must also submit a letter of agreement signed by all the parties*** together.
Article 18 The architectural design of a medical institution must be examined and approved by the setting up approval authority before construction.
Article 19 The time for acceptance of an application for setting up as stipulated in Article 12 of the Regulations shall be counted from the date on which the applicant provides all the materials stipulated in the Regulations and these Rules.
Article 20 The local health administrative department at or above the county level examines and approves the setting up of medical institutions in accordance with the local "Medical Institutions Setting Up Plan" and these Rules.
Applications for the design of medical institutions shall not be approved if any of the following circumstances apply:
(1) the application does not conform to the local "Planning for the Establishment of Medical Institutions";
(2) the setup of the person does not conform to the stipulated conditions;
(3) the person cannot provide proof of creditworthiness to satisfy the total amount of the investment;
(4) the total amount of the investment does not satisfy the budgetary expenditures;
(5) the person cannot meet the budgetary expenditures. p>
(e) medical institutions are not reasonable site;
(f) sewage, dirt, feces treatment program is unreasonable;
(g) provinces, autonomous regions, municipalities directly under the Central Health Administration Department of other circumstances.
Article 21 The administrative department of health shall, at the same time of issuing the Approval Letter for Setting Up Medical Institutions, record it with the administrative department of health at the next higher level.
The higher-level health administrative department shall have the right to correct or revoke, within thirty days from the date of receipt of the filing report, the approval for the setting up of medical institutions made by the lower-level health administrative department which is not in conformity with the local "Medical Institutions Setting-up Plan".
Article 22 The validity period of the Approval for the Establishment of Medical Institutions shall be stipulated by the health administrative department of the province, autonomous region or municipality directly under the central government.
Article 23 Changes in the "approval of the establishment of medical institutions" in the approval of the type of medical institutions, size, location and diagnostic and therapeutic subjects, must be in accordance with the provisions of the regulations and the rules, re-apply for the establishment of the approval procedures.
Article 24 The outpatient departments, clinics and health clinics (rooms) set up by legal persons and other organizations for the service of their internal employees shall be filed by the setting up unit with the local county-level administrative department of health for the record prior to the registration of the practice of the medical institution and the submission of the following materials:
(1) Decision of the setting up unit or its competent department on the setting up of the medical institution;
(2) "Record Book for Setting Up a Medical Institution". Record of Medical Institutions".
The administrative department of health shall, within fifteen days of receipt of the record, give the "Record of Establishment of Medical Institutions".
Chapter III Registration and Verification
Article 25 An application for registration of a medical institution must fill in the Application for Registration of Medical Institution and submit the following materials to the registration authority:
(1) Approval Letter for Setting Up a Medical Institution or Filing Receipt for Setting Up a Medical Institution;
(2) Certificate of Property Rights of the Premises of the Medical Institution or Certificate of Use;
(3) Proof of the ownership or use of the premises;
Application for registration of a medical institution shall be submitted to the administrative department of health. Proof;
(3) Medical institution building design plan;
(4) Certificate of capital verification, asset evaluation report;
(5) Medical institution rules and regulations;
(6) Medical institution's legal representative or the main person in charge, as well as the directory of heads of departments and relevant qualification certificates, practice certificates copies;
(7) Provinces, Autonomous regions and municipalities directly under the Central Health Administrative Department provides other materials.
Application for registration of outpatient clinics, clinics, health centers, infirmaries, health care centers and health stations shall also submit a list of the types of medicines attached to the pharmacy (cabinet), a list of health professionals and their relevant qualifications, certificates of practice, as well as provinces, autonomous regions, municipalities directly under the Central Government of the health administrative department of the other materials required to be submitted.
Article 26 The registration authority in accepting applications for registration of medical institutions, shall, in accordance with the conditions set out in Article 16 of the Regulations and the time limit set out in Article 19 of the Regulations for review and on-site inspection, verification, and on-site sampling of the relevant practitioners of disinfection, isolation, and aseptic operation and other basic knowledge and skills of the test. If the review is qualified, the license to practice in medical institutions 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 disapproval.
"License to Practice in Medical Institutions" and its copy printed by the Ministry of Health.
The time for acceptance of the application for registration of practice as stipulated in Article 19 of the Regulations shall be counted from the day when the applicant provides all the materials stipulated in the Regulations and these Rules.
Article 27 An application for registration of a medical institution shall not be registered if one of the following circumstances applies:
(1) It does not conform to the matters approved in the Approval Letter for Establishment of Medical Institutions;
(2) It does not conform to the Basic Standards for Medical Institutions;
(3) The investment is not in place;
(4) The rooms of a medical institution cannot meet the diagnosis and treatment service
(e) communication, power supply, water and sewage and other public **** facilities can not meet the normal operation of medical institutions;
(f) medical institutions do not meet the requirements of the rules and regulations;
(g) disinfection, isolation, and aseptic operation of the basic knowledge and skills of the on-site sampling assessment failed;
(h) provinces, autonomous regions, municipalities directly under the Central Health Administration Department stipulates other circumstances. Provinces, autonomous regions, municipalities directly under the Central Health Department of other circumstances.
Article 28 Matters for registration of medical institutions:
(1) category, name, address, legal representative or principal person in charge;
(2) form of ownership;
(3) registered capital (capital);
(4) mode of service;
(5) diagnostic and therapeutic subjects;
(6) building area, beds (beds), (beds), (beds) and (beds). ) building area, beds (dental chairs);
(vii) service recipients;
(viii) the number of employees;
(ix) license registration number (code of the medical institution);
(j) provinces, autonomous regions, municipalities directly under the Central Health Administration, the provisions of the other registration matters.
Outpatient clinics, clinics, health centers, infirmaries, health care centers, health centers, in addition to the registration of the matters listed in the preceding paragraph, should also be approved for registration of the attached pharmacy (cabinet) of the type of drugs.
"Directory of Medical Subjects in Medical Institutions" is formulated separately.
Article 29 The medical institutions retained as a result of separation or merger shall apply for registration of change; the new medical institutions set up as a result of separation or merger shall apply for the establishment of the license and registration of practice; the termination of the merger shall apply for cancellation of the registration of medical institutions.
Article 30 Where a medical institution changes its name, address, legal representative or principal person in charge, form of ownership, service recipients, mode of service, registered capital (capital), diagnostic and therapeutic subjects, and beds (dental chairs), it must apply to the registration authority for registration of the change and submit the following materials:
(1) The legal representative or principal person in charge of the medical institution signing the Letter of Application for Change of Registration of Medical Institution"
(ii) Reasons and justifications for the application for change of registration;
(iii) Other materials to be submitted as specified by the registration authority.
Article 31 Medical institutions set up by organs, enterprises and institutions to serve their internal employees and open to the public must apply for change registration in accordance with the provisions of the preceding article.
Article 32 The medical institutions within the jurisdiction of the original registration authority to change the registration matters, the original registration authority for registration of changes; due to changes in registration beyond the jurisdiction of the original registration authority, by the competent health administrative department for registration of changes.
Medical institutions in the original registration authority within the jurisdiction of the area of relocation, the original registration authority for registration of changes; to the original registration authority outside the jurisdiction of the area of relocation, should be in the destination of obtaining the health administrative department issued by the "approval of the establishment of a medical institution", and approved by the original registration authority for cancellation of the registration, and then to the relocation of the destination of the health administrative department to apply for registration of practice.
Article 33 The registration authority accepts the application for change of registration, in accordance with the relevant provisions of the Regulations and the Rules and the local "medical institutions set up planning" for review, in accordance with the registration procedures or simplified procedures for change of registration, and to make a decision to approve the change of registration or not to change the registration.
Article 34 The closure of medical institutions must be approved by the registration authority. In addition to alteration, expansion, relocation reasons, medical institutions shall not be closed for more than one year.
Article 35 of the beds in more than one hundred general hospitals, hospitals of traditional Chinese medicine, hospitals combining traditional Chinese and Western medicine, ethnomedicine hospitals, and specialty hospitals, sanatoriums, rehabilitation hospitals, maternity and child health care hospitals, first aid centers, clinical testing centers, and specialty disease prevention and treatment institutions of the verification period of three years; the verification period of the other health care institutions is one year.
Medical institutions should be three months before the expiration of the verification period to the registration authority to apply for verification procedures.
To lose the verification shall be submitted to the examination of the "medical institutions license", and submit the following documents:
(a) "medical institutions verification application";
(b) "medical institutions license" copy;
(d) provinces, autonomous regions and municipalities directly under the Central Health Administrative Department of the other materials required to be submitted.
Article 36 The health administrative department shall complete the calibration within thirty days after accepting the application for calibration.
Article 37 If a medical institution is in one of the following situations, the registration authority may, depending on the circumstances, grant a deferral period of one to six months for the calibration:
(1) does not comply with the "Basic Standards for Medical Institutions";
(2) during the period of limited time to make corrections;
(3) in other situations as prescribed by the administrative department of health of the province, autonomous region, or province-level municipality directly under the Central Government.
Medical institutions without beds may not practice during the period of temporary calibration.
Suspension of the verification period expired and still can not pass the verification, by the registration authority to cancel its "medical institutions license".
Article 38 The county-level health administrative departments shall, before the end of February each year, the previous year, the administrative region of the practice of medical institutions reported to the Ministry of Health, of which traditional Chinese medicine, traditional Chinese and Western medicine and ethnic medicine medical institutions reported to the State Administration of Traditional Chinese Medicine.
Article 39 The results of the opening, relocation, change of name, change of diagnostic and therapeutic subjects, as well as the closure of medical institutions and the results of the school inspection shall be announced by the registration authority.
Chapter IV Name
Article 40 The name of the medical institution is composed of the identifying name and common name in turn.
The generic names of medical institutions are: hospitals, central health centers, health centers, sanatoriums, maternity and child health centers, outpatient clinics, clinics, health centers, health stations, health offices, infirmaries, health care clinics, emergency centers, first aid stations, clinical testing centers, prevention and treatment hospitals, prevention and treatment stations, nursing homes, nursing stations, centers, as well as the Ministry of Health regulations or other recognized names.
Medical institutions can be the following names as identifying names; names of places, unit names, personal names, names of medical disciplines, names of medical specialties and specialties, names of diagnostic and therapeutic subjects and names approved for use by the approving authority.
Article 41 The naming of a medical institution must conform to the following principles:
(1) The common name of a medical institution shall be limited to the names listed in the second paragraph of the previous article;
(2) The identifying names of medical institutions listed in the third paragraph of the previous article may be used in combination;
(3) The name must be worthy of its name;
(4) The name must be in harmony with the category of medical institutions or diagnostic and therapeutic subjects;
(e) the identifying names of medical institutions set up by local people's governments at all levels shall contain the names of administrative divisions such as provinces, cities, districts, streets, townships, townships, villages, and so on, and the identifying names of other medical institutions shall not contain the names of administrative divisions;
(f) the identifying names of state organs, enterprises and public institutions, social organizations, or individuals who set up The name of the medical institution shall contain the name of the setting unit or the name of the individual.
Article 42 A medical institution shall not use the following names:
(1) names that are detrimental to the interests of the state, society or the public ****;
(2) names that infringe upon the interests of others;
(3) names composed of foreign letters or hanyu pinyin;
(4) names that are named after medical instruments, medicines, or medical products.
(e) names containing "difficult diseases", "specialized treatment", "experts", "famous doctors" or other words of similar meaning. Similar meaning of the name of the text and other publicity or implied diagnostic and treatment effects of the name;
(F) beyond the scope of the registered diagnostic and treatment subjects of the name;
(VII) Provincial or higher health administrative departments shall not be used in the name.
Article 43 The following names of medical institutions approved by the Ministry of Health; belonging to traditional Chinese medicine, combined traditional Chinese and Western medicine and ethnomedicine medical institutions, approved by the State Administration of Traditional Chinese Medicine:
(1) containing the name of a foreign country (region) and its abbreviation, the name of an international organization;
(2) containing the words "China ", "national", "Chinese", "national" and other words, as well as cross-provincial geographical names.
(3) The identifying names of medical institutions set up by local people's governments at all levels that do not contain the names of administrative divisions.
Article 44 The name of a medical institution with "center" as the common name of the medical institution shall be approved by the administrative department of health at or above the provincial level; the approval of the name of the medical institution containing the word "center" in the identifying name shall be prescribed by the administrative department of health of the province, autonomous region, Municipalities directly under the Central health administrative department.
Containing the word "center" in the name of medical institutions must also contain the name of the administrative division or place name.
Article 45 In addition to specialized disease control institutions, medical institutions shall not be specific disease name as the identification of the name, if necessary, by the provincial, autonomous regions, municipalities directly under the Central Health Administrative Department for approval.
Article 46 The name of the medical institutions approved and registered in the receipt of the "license to practice in medical institutions" can only be used within the jurisdiction of the approval authority to enjoy the exclusive right.
Article 47 The medical institutions are allowed to use only one name. If there is a need, two or more names may be used with the approval of the approving authority, but a first name must be determined.
Article 48 The administrative department of health has the right to correct the name of the medical institution that has been approved and registered as unsuitable, and the higher administrative department of health has the right to correct the name of the medical institution that has been approved and registered as unsuitable by the lower administrative department of health.
Article 49 More than two applicants to the same approval authority to apply for the same name of medical institutions, the approval authority in accordance with the principle of application first approved. If the application is made on the same day, it shall be resolved through consultation between the two applicants; if the consultation fails, the approval authority shall make a ruling.
Two or more medical institutions have been approved for registration of medical institutions with the same name dispute, the approval authority in accordance with the principle of registration first. Belonging to the same day of registration, should be resolved by the two sides; consultation fails, the approval authority to report to the higher level of health administration to make a ruling.
Article 50 The name of the medical institution shall not be bought, sold or lent.
Without the permission of the approval authority, the name of the medical institution shall not be transferred.
Chapter V Practice
Article 51 The name used in the seal, bank account, plaque and medical documents of a medical institution shall be the same as the name of the medical institution approved for registration; the use of more than two names shall be the same as the first name.
Article 52 Medical institutions shall strictly implement aseptic disinfection, isolation system, take scientific and effective measures to deal with sewage and waste, and prevent and reduce hospital infections.
Article 53 The retention period of outpatient medical records of medical institutions shall not be less than fifteen years; the retention period of inpatient medical records shall not be less than thirty years.
Article 54 The bills and medical records marked with the logo of the medical institution, as well as the prescription pads, application forms for various tests, reports, certificates, drug bags, preparation labels, etc. shall not be bought, sold, lent and transferred.
Article 55 Medical institutions shall strengthen medical quality management in accordance with the relevant regulations and standards of the health administrative department, implement medical quality assurance programs to ensure medical safety and quality of service, and continuously improve the level of service.
Article 56 of the medical institutions shall regularly check and assess the rules and regulations and all levels and types of personnel job responsibility system implementation and implementation.
Article 57 of the medical institutions should be regularly on the medical staff, "basic theory, basic knowledge, basic skills" training and assessment, the "strict requirements, strict group, rigorous attitude" to the implementation of the work.
Article 58 of the medical institutions shall organize the medical staff to study the code of medical ethics and relevant teaching materials, urging medical personnel to abide by professional ethics.
Article 59 Medical institutions shall not use counterfeit or shoddy medicines, expired or invalid medicines, or prohibited medicines.
Article 60 The medical certificate of death issued by a medical institution for a person whose cause of death is unknown shall only diagnose whether the person is dead or not, and shall not diagnose the cause of death. If the parties concerned request a diagnosis of the cause of death, the medical institution must assign a doctor to conduct an autopsy and examination of the cause of death before a diagnosis of the cause of death can be made.
Article 61 Medical institutions shall, in their diagnostic and therapeutic activities, implement protective medical measures for patients and obtain the cooperation of the patients' family members and relevant persons.
Article 62 Medical institutions shall respect the patient's right to know his condition, diagnosis and treatment. In the implementation of surgery, special examination, special treatment, shall make the necessary explanation to the patient. Due to the implementation of protective medical measures is not appropriate to explain the situation to the patient, the patient's family shall be informed of the situation.
Article 63 of the outpatient clinics, clinics, health centers, infirmaries, health clinics and health stations attached to the pharmacy (cabinet) of the types of drugs approved by the registration authority, the specific measures by the provinces, autonomous regions and municipalities directly under the Central Government health administrative department.
Article 64 Medical institutions serving internal employees shall not be opened to the public without authorization and change of registration.
Article 65 Medical institutions shall not continue to carry out diagnostic and therapeutic activities after their licenses to practice medicine have been revoked or cancelled.
Chapter VI Supervision and Management
Article 66 The health administrative departments at all levels are responsible for the supervision and management of medical institutions in the areas under their jurisdiction.
Article 67 In the supervision and management work, the role of academic and industrial social organizations such as the Society of Hospital Management and the Association of Health Workers shall be given full play.
Article 68 The administrative departments of health at or above the county level shall establish offices for the supervision and management of medical institutions.
The supervision and management offices of medical institutions at all levels work under the leadership of the health administrative departments at the same level.
Article 69 The duties of the supervision and management office of medical institutions at all levels:
(1) to formulate the supervision and management of medical institutions work plan;
(2) to deal with the review of medical institutions supervisors, licensing, and renewal of certificates;
(3) responsible for the registration of medical institutions, the verification of the relevant supervision and management of the work of the statistics and report to the same level of the health administrative department;
(d) responsible for the reception and handling of public complaints against medical institutions;
(e) to complete other supervision and management work assigned by the health administrative department.
Article 70 The health administrative departments at or above the county level shall set up medical institution supervisors to fulfill the prescribed supervisory and management duties. Medical institution supervisors are appointed by the health administrative department at the same level.
Supervisors of medical institutions shall strictly enforce the relevant state laws, regulations and rules, and their main duties are:
(1) to supervise, inspect and guide the implementation of the relevant laws, regulations, rules and standards of the medical institutions;
(2) to supervise, inspect and guide the practice of the medical institutions;
(3) to the medical institutions (c) investigating and collecting evidence in cases of violation of the Regulations and these Rules;
(d) proposing to the administrative department of health opinions on the treatment or punishment of substantiated cases;
(e) imposing penalties within the scope of its authority;
(f) completing other supervisory and management work assigned by the administrative department of health.
Seventy-one medical institutions supervisors have the right to carry out on-site inspection of medical institutions, gratuitous request for relevant information, the medical institutions shall not be refused, hidden or concealed.
Supervisors of medical institutions shall wear badges and show their identification when performing their duties.
Supervisors of medical institutions badge, documents supervised by the Ministry of Health.
Article 72 The administrative departments of health at all levels shall inspect and guide the practice of medical institutions, including:
(1) the implementation of relevant national laws, regulations, rules and standards;
(2) the implementation of the internal rules and regulations of the medical institutions, and the post responsibility system for all levels and types of personnel;
(3) the situation of medical ethics and medical style;
(4) the quality and level of service;
(5) the implementation of medical fees and charges;
(6) organization and management;
(7) the appointment of personnel;
(8) provinces, autonomous regions and municipalities directly under the Central Government health administrative department of the provisions of the other inspection and guidance projects.
Article 73 The state implements an accreditation system for medical institutions, and conducts a comprehensive evaluation of the basic standards, service quality, technical level and management level of medical institutions. Health administrative departments at or above the county level are responsible for the organization and management of medical institution accreditation; medical institution accreditation committees at all levels are responsible for the specific implementation of medical institution accreditation.
Article 74 The administrative departments of traditional Chinese medicine (medicine) at or above the county level to set up a medical institution review committee, responsible for traditional Chinese medicine, combined traditional Chinese and western medicine and ethnic medicine medical institutions.
Article 75 The evaluation of medical institutions includes periodic evaluation and unscheduled key inspection.
The Accreditation Committee of Medical Institutions shall promptly report to the administrative department of health any violation of the regulations and these rules found during the accreditation of medical institutions; members of the Accreditation Committee of Medical Institutions who are supervisors of medical institutions may exercise their supervisory power directly.
Article 76 of the "supervision and management of medical institutions administrative penalty procedures" is formulated separately.
Chapter VII Penalties
Article 77 For those who practice without obtaining the License to Practice in Medical Institutions, they shall be ordered to stop practicing, confiscate their illegal gains and medicines and devices, and be fined not more than three thousand yuan; if any of the following circumstances applies, they shall be ordered to stop practicing, confiscate the illegally obtained medicines and devices, and be fined not less than three thousand yuan and not more than ten thousand yuan:
(1) the medical institution supervising and managing administrative penalties; the members of the Medical Institutions Accreditation Committee shall be the supervisors of the medical institutions. p>
(a) unauthorized practice has been punished by the administrative department of health;
(b) unauthorized practice of non-health technology professionals;
(c) unauthorized practice of more than three months;
(d) causing harm to patients;
(e) the use of fake drugs, inferior drugs to deceive patients;
(f) the name of the practice of medicine to cheat patients money;
(f) the use of medicine to cheat patients money. (F) in the name of practicing medicine to deceive patients;
(VII) provinces, autonomous regions and municipalities directly under the Central Health Administrative Department of other circumstances.
Article 78 of the medical institutions do not apply for the verification of the "license" and does not stop the diagnosis and treatment activities, and shall be ordered to make up for the verification procedures; within the time limit is still not for the verification, the revocation of its "medical institutions license".
Article 79: Anyone who transfers or lends a Medical Institution Practice Permit shall be confiscated of his or her illegal gains and fined not more than 3,000 yuan; if any of the following circumstances applies, his or her illegal gains shall be confiscated, and he or she shall be fined not less than 3,000 yuan and not more than 5,000 yuan, and his or her Medical Institution Practice Permit shall be revoked:
(1) Selling a Medical Institution Practice Permit;
(2) Selling a Medical Institution Practice Permit; and (b) transferring or lending the License to Practice in Medical Institutions for profit;
(c) causing harm to patients by the transferee or the borrower;
(d) transferring or lending the License to Practice in Medical Institutions to a person who is not a health care professional;
(e) the Ministry of Health of the province, autonomous region or municipality directly under the Central Government;
(f) selling the License to Practice in Medical Institutions to a person who is not a health care professional.