Administrative Measures For The Guangxi Zhuang Autonomous Region Medical Institutions

Original Language Title: 广西壮族自治区医疗机构管理办法

Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/dfzfgz/201206/20120600369177.shtml

Administrative measures for the Guangxi Zhuang Autonomous Region medical institutions

    (December 31, 2011 Executive meeting of the people's Government of Guangxi Zhuang Autonomous Region, the 98th on January 19, 2012, people's Government of Guangxi Zhuang Autonomous Region, the 74th release come into force on April 1, 2012) Chapter I General provisions

    The first in order to strengthen the management of medical institutions, regulate the practice of medical institutions, promote the development of medical and health services, according to the State Council's regulations on the management of medical institution and the provisions of relevant laws and regulations, combined with this practice, these measures are formulated.

    Article this setting of medical institutions in the administrative area, registration, verification, code of practice, supervision and administration of the application of this approach.

    Medical institutions in these measures include all types of hospitals, maternal and child health hospital, community health centers (stations), hospitals (station, and ventricular), nursing homes, hospital for specialist disease (standing), outpatient departments, clinics, nursing homes (station), clinic, health, first aid Centre (stations), the clinical testing centre.

    Disease prevention and control, the frontier health and quarantine, medical research and teaching, medicine, diagnosis and treatment of institutions such as the family planning services outside the scope of business activities and beauty services carry out cosmetic operations, approved by the law setting the appropriate category of medical institutions.

    Article management of medical institutions to implement localized and whole-sector management.

    Fourth article County above Government should will medical institutions construction into local economic social development planning and urban and rural construction general planning, integration and optimization configuration medical resources; insisted public medical institutions for led, and non-public medical institutions common development, non-profit sex medical institutions for subject, and profit sex medical institutions for added; implementation medical institutions Government grants, and compensation policy, established and perfect cover urban and rural residents of medical service system. Fifth people's Governments above the county level health Administrative Department is responsible for the medical institutions within their respective administrative areas of unified planning, unified access, unified regulation.

    Relevant departments of supervision and administration of medical institutions in accordance with their respective responsibilities.

    Chapter II establishment of medical institutions

    Sixth Department of the people's Governments above the county level health should be based on the administrative area population, economic and medical resources, medical needs, distribution of existing institutions, prepare or amend the establishment of medical institutions planning, by a higher administrative Department of health under the examination and approval of, the people's Governments at the corresponding level for approval, and announced to the public.

    Medical establishment planning preparation or revision shall be synchronized with the level construction and development of urban and rural overall planning.

    Seventh administrative departments of people's Governments above the county level health proposed a new set of medical institutions shall, in accordance with local medical institutions set quantitative limits provided for in planning approval.

    New urban setting non-public medical institution has adopted open competition determined set of people.

    Eighth request establishment of a medical institution shall meet the following conditions:

    (A) establishment of medical institutions planning;

    (B) the organizational structure, staffing, equipment configuration, and in line with similar medical institutions of basic standards set by the State;

    (C) set independently assume civil liability;

    (D) provide a total investment of credit;

    (E) medical waste treatment project is reasonable;

    (Vi) other conditions stipulated by laws and regulations.

    Nineth application for establishment of a private clinic, in addition to the conditions prescribed by article eighth of this approach, but should also meet the following conditions:

    (A) I qualified as a practitioner, certified registered continuously in the same specialty clinics for more than 5 years;

    (B) belongs to the clinical or oral traditional Chinese medicine and Western medicine category.

    Article tenth of the establishment of a medical institution shall make application to the Administrative Department of health approval for, and in accordance with the requirements to submit written material.

    11th health administrative departments shall, in accordance with the following permissions to set up approval of medical institutions:

    (A) the tertiary hospital and maternal and child health hospital, specialist disease control Institute (), and municipality directly under the administration of health care institutions, ambulatory care centers, clinical laboratory, medical test, cosmetology hospitals, voluntary drug rehabilitation institutions, district of the city established by administrative departments of health under examination, Government approval of the public health Administrative Department;

    (Ii) two level hospital, and two level and the following hospital, and specialist disease control Hospital (by), and specialist hospital, and TCM hospital (containing integrated Chinese and Western medicine combined, and national medical), set bed 100 Zhang above of rehabilitation hospital, and nursing hospital, and nursing home and medical beauty clinic (clinic),, by County Government health administrative sector audit Hou, reported set district of city government health administrative sector approval;

    (C) in township hospitals, community health centers (stations), no bed for less than 100 beds and other medical institutions, by the approval of the Administrative Department of health under the County;

    (D) set up Sino-foreign joint venture and cooperative medical institutions by districts after the municipal public health Administrative Department, Department of the autonomous regional people's Government health and business administration departments for approval;

    (E) the Hong Kong and Macao medical service providers in the establishment of a private clinic in the State, from the area after the municipal public health Administrative Department, Administrative Department of health under the approval of the autonomous region.

    Set of public medical institutions, should be prepared by the Administrative Department of public health reported to the people's Government at the institution authority for approval. 12th the health Administrative Department before issuing its approval of the establishment of a medical institution, public should be published for a period of 5 working days.

    Publication include: proposed establishment of a medical institution's name, class, level, address, medical subjects, bed, set the applicants name and whether or not in accordance with local planning and other medical organizations.

    13th article of the approval of the establishment of a medical institution is valid for:

    (A) the clinics and health centers (stations,, post), health centers, dispensaries, clinics and other medical institutions not located bed for 1 year;

    (B) less than 100 beds of medical institutions, clinical laboratory, medical test for 2 years;

    (C) more than 100 bed medical facility for 3 years.

    Expired without applying for a practising registered, book of the approval of the establishment of a medical institution shall automatically cease.

    Article 14th medical institution to change the approved categories, levels, or addresses, should again set approval formalities.

    Health care agencies need to set up a branch of medical institutions shall, in accordance with the new provisions of the approval procedures of the establishment of a medical institution.

    Chapter III registration and verification

    15th medical institutions in the complete book of the approval of the establishment of a medical institution approved by the matter, shall apply to the Department of the approved set of health practice registration, receive a medical practice license.

    Setting drug medical institutions or medical institutions engaged in drug treatment services and setting up Sino-foreign joint venture and cooperative medical institutions, and cities divided into districts shall be the Administrative Department of health under application for practising registration; opened private clinics in Hong Kong and Macao medical service providers should apply to the District of the municipal public health Administrative Department practice registration.

    16th practice registration the applicant shall submit the following materials:

    (A) application for practising registration;

    (B) the letter of approval of the establishment of medical institutions;

    (C) the certificate of house property right or the certificate;

    (D) building or business plans;

    (E) capital verification certificate, appraisal reports;

    (F) the legal representative or principal responsible person, list of Heads of the various departments;

    (VII) physician, registered nurse practitioner application materials;

    (H) the main instruments directory listing;

    (I) the disinfection and supply facilities and medical waste disposal programmes;

    (J) the Administration and technical operation of the system. 17th the health Administrative Department shall, within 45 days from the date of acceptance, to apply for a practising of medical institutions by field inspection, item-by-item review.

    Meet the requirements, issue a practising certificate for medical institution; do not meet the conditions, grounds of refusal in writing.

    The practising certificate for medical institution and its copy in accordance with the specifications of the Ministry of health provides, printed by the people's Governments above the county level health Administrative Department.

    18th medical organizations registration of names approved by the health Administrative Department before using. Medical institutions are only allowed to register a type and a name.

    There is need to use two names shall be approved by the health Administrative Department, and determine the first name as the registration name.

    Name of 19th medical institutions shall comply with the requirements set by the State, there shall be the following:

    (A) detrimental to national, social or public interest;

    (B) infringes the legitimate rights and interests;

    (C) foreign letters, Hanyu Pinyin, composed;

    (D) medical instruments, medicines, product naming;

    (E) promote or suggest that clinical results;

    (F) beyond the scope of registration of medical subjects;

    (VII) words as men, male or female;

    (VIII) as a non-affiliated organization or non-affiliated medical institution recognition name;

    (IX) as administrative divisions (Government medical institution and except as provided in the article 20th).

    20th medical institution name contains "Guangxi" and a zone name or to cross city and county boundaries "Center" as a generic name, distinguished name of medical institutions (excluding central hospitals, community health centers), approved by the Department of the autonomous regional people's Government health.

    Name of medical institution with "China", "national", "Chinese", "country", "Association", "international", as well as foreign countries (regions) and names of international organizations, shall be approved by the municipality after the administrative departments of public health, reported the health Administrative Department under the State Council for approval.

    21st medical organizations changed name, legal representative or principal responsible, business properties, bed (Chair) and medical subjects, registration of medical practitioners, health administrative departments shall provide the original registration to apply for alteration registration procedures. 22nd medical institutions carry out calibration system.
Medical institutions shall in accordance with the calibration period to the registration authority for the verification of the following:

    (A) the beds in general hospitals, over 100 Chinese medicine (with combination of traditional Chinese and Western medicine, national medical) hospitals and specialized hospitals, rehabilitation hospitals, nursing homes, hospital, first-aid centers, clinical laboratory, medical testing and calibration specialist disease control institutions for a period of 3 years, other health institutions validation period is 1 year;

    (B) joint venture medical institutions verify for a period of 1 year;

    (C) the suspension of next calibration check again after checking compliance of medical institutions for a period of 1 year.

    Article 23rd medical institution shall, within 3 months before the expiry of the validation period registration authority for verification, and submit the following materials:

    (A) the application for verification of medical organizations;

    (B) the practising certificate for medical institution and its copy;

    (C) verification cycle practice report;

    (D) the health administration departments under the people's Government of the autonomous region's other material.

    Private clinics to apply for calibration beyond the materials prescribed by the preceding paragraph, shall also submit the certificate of recent health practitioners. 24th the registration authorities shall accept an application for checking the date of 30th to complete validation review and validate conclusions. Check conclusions into suspension calibration and checking compliance.

    Suspension calibration suspension calibration periods should be identified, suspension calibration for 1-6 months.

    Suspension calibration period, may not carry out diagnosis and treatment in medical institutions not set bed set bed outside medical institutions, in addition to first aid, may not carry out clinic operations and treat new patients.

    25th medical institution has any of the following circumstances, the registration authority may cancel its license to practice medical organizations:

    (A) the calibration period, more than 30th calibration;

    (B) deferred again after calibration calibration is not qualified;

    (C) the unjustified termination of medical activities, or go out of business more than 1 year;

    (D) other circumstances as stipulated by laws and regulations shall be revoked.

    Determined by the calibration does not have medical subjects, registration authorities can remove the medical subjects.

    The fourth chapter practice criteria

    Article 26th has not obtained the practising certificate for medical institution shall not carry out diagnosis and treatment. Medical institutions shall, in accordance with the practising certificate for medical institution approved by practicing registration matters clinic activities.

    The practising certificate for medical institution shall be suspended in clinic settings effective.

    27th medical organizations may not use the medical practice license and medical organisations sell, transfer, lease, or lending; medical locations may not be leased, contracted out to other bodies or persons clinic activities carried out in the name of the medical institution.

    28th medical institutions to carry out diagnosis and treatment should have a corresponding health technicians, facilities, equipment and quality control systems, and technical compliance management practices.

    Medical institutions do not use non-health professionals in health care technology, not allowed health professionals practise outside of his professional activities.

    29th medical institutions should strengthen the management of drug clinical application, and implementation of a national system for basic drugs, in accordance with the provisions and the use of essential drugs; use of narcotic drugs, toxic drugs, psychotropic drugs and radioactive drugs shall conform to the national requirements.

    Medical institutions not yet registered doctors, nurses and by the qualification of pharmacy technicians, no corresponding emergency medical supplies, no intravenous drug business.

    30th medical institutions should strengthen infection, strict implementation of disinfection and isolation system, and take effective measures to address sewage and medical waste, hospital infection prevention and control.

    31st medical institutions shall perform the services of public health and emergency rescue obligations to undertake medical treatment related to the prevention of infectious diseases and disease prevention work within their area of responsibility; timely report the detection of infectious disease outbreaks, and to take effective measures to control the spread of the epidemic; public emergencies or emergency needs, medical institutions and medical personnel should be subject to the administrative departments of public health fields.

    Medical institutions and medical staff should participate in the administrative departments of public health organizations support and primary health care services, and so on.

    32nd medical organizations should implement national and State policy on charges for health care services provided, without additions or raise fees.

    Article 33rd medical institution shall properly keep the medical instruments, maintain its authentic and complete, are not allowed to modify, alter, conceal, falsify and early elimination. Charges issued by a medical institution documents, accounts, stub medical evidence and other documents shall be kept for more than 15 years, medical records retention for more than 30 years.

    Prescriptions issued by expiration in accordance with the relevant provisions of the State.

    Medical agencies shall not issue a false inspection report, as well as diagnosis and treatment, medical certificates such as birth and death.

    Article 34th release medical advertisements in medical institutions shall obtain the regional government medical advertisement issued by the administrative departments of health under review shows that advertising may not go beyond the review show that the approved range. 35th medical operation, special examination or special treatment, should be explained to patients in a timely manner medical risks, alternative health care, and so on, and has obtained the written consent should not be explained to patients, patients close relative or guardian's written consent shall be obtained.

    But due to the treatment needs of dying patients, failed to obtain the consent of patients or their close relatives, guardians, and approved by the head of the head of the medical institution or authorized, appropriate medical measures could be implemented immediately.

    36th medical institution without approval, may engage in the diagnosis of genetic diseases, prenatal diagnosis and termination of pregnancy and the sex of the fetus, as well as other activities such as family planning operation.

    Fifth chapter of supervision and inspection

    37th at a higher level people's Government administrative departments for public health shall strengthen the supervision and inspection on subordinate administrative departments of health under, correct practise in medical institutions for approval, registration, verification and violation of law enforcement and inspection.

    Article 38th of health administrative enforcement of health supervision and inspection personnel for medical institutions, shall exercise the following powers:

    (A) places of on-site inspections related to diagnosis and treatment;

    (B) asking the parties, investigate the relevant circumstances;

    (C) access to and obtaining relevant information;

    (D) in the case of evidence may be destroyed or lost or difficult to obtain later on, by the health Executive Heads agreed that places related articles on diagnosis and treatment can be registered for keeping.

    Shall cooperate with medical institutions and their staff shall not refuse, conceal, conceal. 39th health administrative law enforcement personnel shall conduct supervision and inspection of medical institutions, supervision and inspection of the circumstances and consequences should be recorded.

    Supervision and inspection record should be considered as medical institutions verify, review or an important basis of the case.

    40th medical institutions shall establish and improve the quality of medical service system, to post timely rectification of problems found, and submitted to the registration authority in January of each year an annual medical quality self test report on.

    Medical institutions do not submit annual medical service quality on self test report or calibration cycle practice self test is not in the report, to reorganize the contents of, registration authority can be suspension calibration.

    41st people's Governments above the county level health Administrative Department is responsible for organizing the medical Agency Review Committee, in accordance with national and State Administrative Department of health under the relevant assessment methods and criteria for medical institutions, medical practice, medical service quality evaluation, to review conclusions.

    Review conclusion as grading medical institutions, an important basis for validation of practice.

    42nd medical institutions shall establish a sound financial management system and the asset management system, accept supervision and inspection departments.

    Configuration of large medical equipment in medical institutions, medical institutions according to the territorial principle of applying to the Administrative Department of health under the seat, escalation, obtain a permit before they can purchase.

    The sixth chapter legal liability

    Article 43rd acts in violation of these rules, laws and regulations have legal liability provisions from its provisions.

    44th medical institutions in violation of the provisions of this article 22nd article, fails to check the practising certificate for medical institution, the people's Governments above the county level health administrative departments ordered to check who refuses to check, revocation of license to practice medical organizations according to law.

    Medical institution in violation of the second paragraph of article 24th, during the period of suspension calibration without diagnosis and treatment, health administration under the people's Governments above the county level shall be ordered to correct and may be fined a maximum of 1000 Yuan and 10,000 yuan.

    Article 45th disobey article 26th, without the practising certificate for medical institution without diagnosis and treatment, health administration under the people's Governments above the county level shall be ordered to stop practicing, illicitly acquired and confiscated drugs, weapons, and a fine of up to 100,000 yuan.

    Article 46th disobey article 27th medical institutions, medical premises leased, contracted out to other bodies or persons clinic activities carried out in the name of the medical institution, the people's Governments above the county level administrative Department of public health fined 10,000 yuan and 50,000 yuan fine.

    47th medical institutions do not have the conditions specified in the second paragraph of article 29th, medicine business in veins, the people's Governments above the county level health administrative departments a rectification, it fails, a fine of 3000 Yuan and 30,000 yuan fine.

    48th medical institution in violation of the provisions of article 36th without approval, arbitrarily engaged in genetic disease diagnosis, prenatal diagnosis and termination of pregnancy, by the people's Governments above the county level health administrative departments shall issue a warning, confiscated illegal gains and related to drugs, medical devices, and a fine of 5000 Yuan and 20,000 yuan fine.

    The seventh chapter by-laws 49th article of the measures shall take effect on April 1, 2012. 2000 Guangxi Zhuang Autonomous Region people's Government promulgated the interim measures for the management of medical organizations at the same time repealed.