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Interim measures for the administration of record management of traditional Chinese medicine clinics

2017年11月19日

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Interim measures for the administration of record management of traditional Chinese medicine clinics


Release date: 2017-11-16
Order of the national health and family planning commission of the People's Republic of China


No. 14,
The interim measures for the management of the registration of traditional Chinese medicine clinics was discussed at the meeting of the chairman of the national health and family planning commission on July 31, 2017, and will be implemented as of December 1, 2017.
The director of the Li bin
September 22, 2017
Interim measures for the administration of record management of traditional Chinese medicine clinics
Chapter I general rules
Article 1 with a view to the management of clinic of traditional Chinese medicine for the record, according to the law of the People's Republic of China law of traditional Chinese medicine and the "regulations on the administration of medical institutions" and other relevant provisions of the laws and regulations, these measures are formulated.
Referred to in article 2 hereof clinic of traditional Chinese medicine, it is under the guidance of TCM theory, using the traditional Chinese medicine and acupuncture, cupping, massage and other non-drug therapy in medical services, as well as the traditional Chinese medicine dispensing and one decoction, etc. The clinic of traditional Chinese medicine pharmacy practice. These measures are not applicable to the scope of service or the existence of uncontrollable medical safety risks and risks.
Article 3 the state administration of traditional Chinese medicine is responsible for the administration of TCM clinics in China.
The competent departments of traditional Chinese medicine at or above the county level shall be responsible for the supervision and administration of traditional Chinese medicine clinics in their respective administrative areas.
The competent department of Chinese medicine at the county level is responsible for the filing of the TCM clinic in this administrative region.
Chapter ii preparation
Article 4 in the event of the establishment of a TCM clinic, the ministry of traditional Chinese medicine in the place where the clinic is to be held shall be able to carry out the practice activities.
Article 5 the following conditions shall be provided for the holding of TCM clinics:
(a) personal clinic of traditional Chinese medicine, should have the category of traditional Chinese medicine the doctor qualification certificate and after registration in medical treatment, prevention or health care professional full three years, or have "(specialty) of traditional Chinese medicine doctor qualification certificate"; Where a legal person or any other organization holds a TCM clinic, the main person in charge of the clinic shall meet the above requirements;
(2) meeting the basic standards of TCM clinics;
(3) the name of the TCM clinic conforms to the relevant provisions of the regulations on the implementation of the management regulations of medical institutions;
(4) relevant provisions of environmental protection and fire protection;
(5) to be able to bear civil liabilities independently.
The regulations on the implementation of the regulations on the management of medical institutions shall not apply for the establishment of units or individuals of the medical institutions and shall not hold a TCM clinic.
Article 6 the Chinese medicine clinics shall submit the following materials:
(I) the registration information table of TCM clinics;
(2) effective identification certificate, certificate of physician qualification and practice certificate of physician;
(3) the directory of other health technicians, valid identification and practice certificates;
(4) administrative rules and regulations of TCM clinics;
(5) description of the medical waste treatment plan and the surrounding environment of the clinic;
(6) fire fighting emergency plan.
If a legal person or other organization holds a TCM clinic, it shall also provide the qualification certificate of a legal person or other organization, the identity certificate of the legal representative or the representative of other organizations.
Article 7 the record holder shall truthfully provide the relevant materials and reflect the real situation, and shall be responsible for the authenticity of the material contents of the filing materials.
Article 8 after receiving the filing materials, the competent department of Chinese medicine at the county level shall file a record of the complete materials and meet the requirements for the record, and issue the certificate of registration of TCM clinics on the spot. If the material is not complete or does not meet the requirements of the record, it shall be notified to the record person on the spot or within five days from the date of receipt of the filing materials that the record person needs to make up all the contents.
The state has gradually promoted the informationization of TCM clinic management, which can be applied online for filing.
Article 9 TCM clinics shall publicize the registration certificate of TCM clinics and the information of health technicians in the clinic.
Article 10 the actual setting of personnel, name and address of a TCM clinic shall be consistent with the record of the record of the TCM clinic.
If the names, places, major principals, clinical subjects and technologies of TCM clinics are subject to changes, they shall be filed with the original record office in a timely manner for the record of the changes.
Article 11 forgery, sale, transfer or lending of the certificate of TCM clinics shall be prohibited.
Article 12 the shall, in accordance with the record of the clinic diagnosis and treatment subject of traditional Chinese medicine, diagnosis and treatment of technology to carry out to strengthen the medical behavior, medical quality and medical safety management, and in accordance with the traditional Chinese medicine medical technology correlation infection prevention and control and other relevant provisions.
Medical advertisements issued by TCM clinics shall comply with the provisions of laws and regulations and prohibit false and exaggerated publicity.
Article 13 at the county level shall be issued by the competent department of traditional Chinese medicine in the clinic of TCM registration certificate within 20 days as of the date of filing within their respective jurisdictions of TCM clinic information publicly in the government websites, facilitate social inquiry and supervision, and in a timely manner at the next higher level department in charge of traditional Chinese medicine to submit the clinic of traditional Chinese medicine for the record information within their respective jurisdictions. The competent department of traditional Chinese medicine shall conduct verification and find that the items not conforming to the provisions of this method shall be corrected within 30 days.
Chapter iii supervision and administration
Article 14 the competent departments of traditional Chinese medicine at or above the county level shall strengthen the supervision and administration of the practice, medical quality and medical safety and clinic management of TCM clinics.
Article 15 the department in charge of traditional Chinese medicine at the county level shall be from the clinic of TCM for record within 30 days from the date of the registration site verification to the clinic of traditional Chinese medicine, to verification of relevant materials, and regularly carry out supervision and inspection on site.
Article 16 in any of the following situations, the TCM clinic shall report to the competent Chinese medicine department at the county level, and the competent Chinese medicine department at the county level shall cancel the filing and make a timely announcement to the society:
(1) the cessation of practice activities in traditional Chinese medicine clinics for more than a year;
(2) the major principals of traditional Chinese medicine clinics shall be revoked of their practice certificates or be investigated for criminal responsibility;
(3) the legal person or other organization that holds a TCM clinic terminates according to law;
(4) voluntary termination of practice activities by Chinese medicine clinics.
Article 17 the competent department of traditional Chinese medicine at the county level shall organize regular learning, head of the Chinese medicine clinic health laws and regulations and infection prevention and control of medical institutions, the prevention and treatment of infectious diseases, such as knowledge, promote the traditional Chinese medicine clinic practice in accordance with the law; Regularly organize practitioners to participate in education and improve their professional skills.
Article 18 the competent department of traditional Chinese medicine at the county level shall set up a Chinese medicine clinic practice behavior record system is bad, the irregularities, unreasonable fees, such as false advertising for recording, and as an important basis for supervision and management of TCM clinic.
Chapter iv legal responsibilities
Article 19 the local department in charge of traditional Chinese medicine at or above the county level shall not carry out the duties specified in the present measures, to satisfy the conditions for the record but failed to issue registration certificate or fails to inform on package material, need not within the prescribed time limit for the record in the local public area of the traditional Chinese medicine clinic information, not in accordance with the law, conduct supervision and management of according to the traditional Chinese medicine act dealt with the provisions of article 53.
Article 20 in violation of the provisions of these measures, to practice without county departments for the record of Chinese medicine, Chinese medicine departments at the county level shall order correction, confiscate the illegal income derived therefrom and concurrently impose a fine of less than RMB thirty thousand, announced to the public information; If the person refuses to correct, he shall be ordered to cease his practice activities, and the person directly responsible shall not engage in the relevant activities of traditional Chinese medicine within five years from the date of the decision of the punishment decision.
Article 21 submitted false record filing materials obtained in the clinic of TCM for the record card ", Chinese medicine departments at the county level shall order correction, confiscate the illegal income derived therefrom and concurrently impose a fine of less than RMB thirty thousand, announced to the public information; If the person refuses to correct, he shall be ordered to cease his practice and cancel the registration certificate of the TCM clinic. The person directly responsible shall not engage in the relevant activities of traditional Chinese medicine within five years from the date of the decision of the punishment decision.
Article 22 in violation of the provisions of article 10 of the present measures, the Chinese medicine clinic to change the Settings without registration or actual Settings and the "Chinese medicine clinics for the record card" particulars not consistent, shall not carry out diagnosis and treatment activities. The competent departments of Chinese medicine at the county level shall be ordered to make corrections and shall be given a warning and fined not less than RMB 10,000 yuan or less than 30,000 yuan. If the circumstances are serious, they shall be ordered to stop practising and cancel the registration certificate of TCM clinics.
Article 23 in violation of the provisions of article 11 of these measures, sell, transfer, loan in the clinic of TCM for the record card ", Chinese medicine departments at the county level shall order correction, given a warning and may concurrently be fined between ten thousand yuan and thirty thousand yuan; If the circumstances are serious, they shall be ordered to stop practising and cancel the registration certificate of TCM clinics.
Article 24 the TCM clinic is beyond the scope for the record to carry out medical activities, shall be ordered to correct by the competent department of local county traditional Chinese medicine, confiscate the illegal income, and be fined between RMB ten thousand yuan and ten thousand yuan. Any of the following circumstances, shall be ordered to stop the practice, the cancellation of "TCM clinic record card", the person in charge directly responsible for the penalty decision made five years from the date of may engage in management work in medical institutions:
(1) having been subject to administrative punishment for carrying out medical activities beyond the scope of the record;
(2) engaging in medical activities beyond the record scope to cause injury to the patient;
(3) those who violate the provisions of these measures for other serious consequences.
Chapter v supplementary provisions
Article 25 the requirements for management of traditional Chinese medicine clinics that are not specified in these measures shall be implemented in accordance with relevant laws and regulations and regulations governing the administration of national medical institutions.
Article 26 the format of the registration information table of TCM clinics and the registration certificate of TCM clinics shall be regulated by the state administration of traditional Chinese medicine.
Article 27 the measures have been set before the implementation of traditional Chinese medicine clinic, in conformity with the conditions of the measures for the record, before the expiry of the validity of the "practice license of medical institution", can according to the requirements of the "regulations on the administration of medical institutions" management, also can be in accordance with the requirements for filing management; Other clinics that do not qualify for the record are still subject to regulatory approval in accordance with the regulations of the management of medical institutions.
Article 28 the time limit prescribed in these measures shall be calculated on a working day.
Article 29 these measures shall enter into force as of December 1, 2017.