Medical institutions that are required to obtain a Medical Institution Practice License before providing traditional Chinese medicine services include: TCM hospitals, integrated TCM–Western medicine hospitals, ethnic medicine hospitals, TCM outpatient departments, integrated TCM–Western medicine outpatient departments, ethnic medicine outpatient departments, TCM (general) clinics, integrated TCM–Western medicine clinics, ethnic medicine clinics, as well as TCM departments in general hospitals, TCM departments in township health centers, and TCM departments in community health service centers.

Verify whether the Medical Institution Practice License has approved and registered Traditional Chinese Medicine (including Integrated Traditional Chinese and Western Medicine and Ethnic Medicine) as a clinical specialty, and whether clinical practice is conducted in accordance with the approved and registered specialties.

Conduct supervision and inspection of the institutional qualifications and practice activities of TCM clinics.

(1) Supervision and Inspection of Professional Qualifications

1. When a traditional Chinese medicine clinic commences practice, it shall file with the TCM administrative department of the people’s government at the county level in the locality information including the clinic’s name, address, scope of diagnosis and treatment, and staffing composition, and obtain a “Registration Certificate for Traditional Chinese Medicine Clinics.”

2. Whether the filer has truthfully submitted the relevant materials and provided an accurate account of the actual situation. When filing a Traditional Chinese Medicine (TCM) clinic, the following materials shall be submitted: (1) the “TCM Clinic Filing Information Form”; (2) valid identification of the principal person in charge of the TCM clinic, along with the physician qualification certificate and the physician practice certificate; (3) a roster of other health technical personnel, together with their valid identification and practice qualification certificates; (4) the management rules and regulations of the TCM clinic; (5) a plan for the disposal of medical waste and a description of the surrounding environmental conditions of the clinic; and (6) an emergency response plan for fire safety. If the TCM clinic is established by a legal person or other organization, such entity shall also provide proof of its qualifications, as well as proof of the identity of its legal representative or the representative of the organization.

3. Whether the actual personnel, name, address, and other particulars of a TCM clinic are consistent with the information recorded on its “TCM Clinic Filing Certificate.” If any changes occur in the filed particulars of the TCM clinic—such as its name, premises, principal person in charge, clinical specialties, or technical services—has the clinic promptly submitted the relevant amendment for filing with the original filing authority?

(2) Supervision and Inspection of Professional Practice

1. Whether the TCM clinic has forged, sold, transferred, or lent out its “TCM Clinic Filing Certificate.”

2. Does the TCM clinic conduct medical services in accordance with the registered clinical specialties and techniques?

3. Has the holder of the “Traditional Chinese Medicine Clinic Filing Certificate” suspended practice for more than one year?

Inspect the issuance of traditional Chinese medicine medical advertisements by medical institutions.

1. Medical institutions shall obtain review and approval from the TCM administrative department of the people’s government of the province, autonomous region, or municipality directly under the central government where they are located before publishing TCM medical advertisements; such advertisements shall not be published without such review and approval.

2. Whether the published TCM medical advertisements conform to the content that has been reviewed and approved, and comply with the relevant provisions of the Advertising Law of the People’s Republic of China.

Cases suspected of violating the Advertising Law of the People’s Republic of China shall be immediately referred to the market supervision and administration authorities.

Supervise and inspect the practice qualifications and professional activities of TCM physicians who have obtained physician qualifications through examination.

(1) Supervision and Inspection of Professional Qualifications

1. Verify whether the “Physician Qualification Certificate” in the category of Traditional Chinese Medicine has been obtained.

2. Verify whether the Physician Practice Certificate has been obtained.

(2) Supervision and Inspection of Professional Practice

For TCM physicians who have obtained physician qualification through examination, when using restricted medical technologies in their specialized field that are subject to specific national regulations, have they undergone training in accordance with the relevant national provisions and passed the corresponding assessment?

Conduct supervision and inspection of the practice qualifications and practice locations of physicians specializing in traditional Chinese medicine.

1. Shall physicians who have obtained the “Certificate of Qualification for Physicians Specializing in Traditional Chinese Medicine” register for practice in accordance with the assessment content, and, upon such registration, obtain the “Practice Certificate for Physicians Specializing in Traditional Chinese Medicine,” and shall they engage in TCM medical practice only within the scope of their registered practice?

2. Physicians specializing in traditional Chinese medicine may practice within the provincial administrative region where they were assessed; if they intend to practice in another province, they must obtain approval from and register with the provincial TCM administrative authority of the intended practice location.

Inspections of traditional Chinese medicine decoction pieces primarily focus on oversight and compliance in areas such as personnel qualifications, procurement, acceptance inspection, storage, and dispensing.

(1) Supervision and inspection of personnel requirements

1. Are individuals directly engaged in the technical work of processed Chinese medicinal materials considered professional and technical personnel in Chinese pharmacy? At tertiary hospitals, there shall be at least one professional and technical personnel holding the title of associate chief pharmacist or higher; at secondary hospitals, there shall be at least one professional and technical personnel holding the title of chief pharmacist or higher; and at primary hospitals, there shall be at least one pharmacist or a person with professional and technical competence equivalent to that of a pharmacist or higher.

2. For those responsible for the acceptance inspection of traditional Chinese medicine decoction pieces, in hospitals at or above Grade II, such personnel shall hold a professional technical title of intermediate level or higher and have experience in the identification of decoction pieces; in Grade I hospitals, such personnel shall hold a professional technical title of junior level or higher and have experience in the identification of decoction pieces.

(2) Supervision and Inspection of the Procurement of Traditional Chinese Medicine Decoction Pieces

1. When a hospital purchases processed Chinese medicinal herbs, does it verify the manufacturing and operating enterprises’ Drug Production License or Drug Distribution License, Business License for Corporate Legal Persons, as well as the sales personnel’s power of attorney, qualification certificates, and identification cards, and file copies for future reference? For processed Chinese medicinal herbs subject to approval-number management by the state, does the hospital verify the registration certificate and file a copy for future reference?

2. Has the hospital entered into a “Quality Assurance Agreement” with the supplier of traditional Chinese medicine decoction pieces?

3. Does the hospital conduct regular assessments of the quality of Chinese medicinal decoction pieces supplied by its vendors and, based on the assessment results, promptly adjust the vendors and supply arrangements?

(3) Supervision and inspection of the acceptance of traditional Chinese medicine decoction pieces

When purchasing Chinese medicinal decoction pieces, do the receiving personnel meticulously record and sign off on each item, including the product name, place of origin, manufacturer, batch number, production date, certificate of compliance, quality inspection report, quantity, inspection results, and date of inspection? For Chinese medicinal decoction pieces subject to approval-number management by the state, is the approval number carefully checked and verified? If counterfeit or substandard Chinese medicinal decoction pieces are discovered, are they promptly sealed and reported to the local drug administration authority?

(4) Supervision and inspection of the storage of traditional Chinese medicine decoction pieces

1. Does the Chinese medicinal herb decoction piece warehouse have an area commensurate with the volume of usage and is it equipped with facilities and conditions for ventilation, temperature and humidity control, moisture prevention, pest control, and rodent control?

2. Are there complete records for the inbound and outbound movements of traditional Chinese medicine decoction pieces? Prior to dispatch, are these pieces rigorously inspected and verified, with any nonconforming items prohibited from being released for use?

3. Are regular maintenance inspections conducted on Chinese medicinal decoction pieces, and are the inspection results duly recorded? If quality issues are identified during maintenance, are they promptly reported to the unit’s leadership for handling, and are appropriate corrective measures implemented?

(5) Supervision and inspection of the dispensing of traditional Chinese medicine decoction pieces

1. Does the Chinese medicinal herb decoction dispensing room have an area commensurate with the volume of dispensing, and is it equipped with ventilation, temperature and humidity control, moisture-proof, pest-control, rodent-proof, and dust-removal facilities? Are the work area and work surfaces kept clean and hygienic?

2. Measuring instruments used for hospital dispensing shall be periodically verified in accordance with the regulations of the quality and technical supervision authorities; those that fail verification shall not be used.

3. After the preparation of traditional Chinese medicine decoction pieces, are they dispensed only after being reviewed and verified? In hospitals at or above Grade II, is the dispensing and verification process conducted by qualified technical personnel holding the title of chief pharmacist or higher in traditional Chinese medicine, and does the verification rate reach 100%?

4. Does the hospital conduct regular spot checks on the quality of traditional Chinese medicine decoction piece dispensing and record the inspection results? Is the weight deviation for each dose of decoction pieces within ±5%?

5. When compounding prescriptions containing toxic Chinese medicinal decoction pieces, must the dosage for each prescription not exceed the maximum daily dose for two days? For prescriptions that do not specify “to be used in raw form,” should processed preparations be dispensed instead? If doubts arise during prescription review, must the prescription be re-validated by the prescribing physician before compounding can proceed? Must prescriptions be retained for two years for inspection purposes?

6. Is poppy shell dispensed as a single-ingredient preparation, and is it only available upon presentation of a pale-red prescription signed by a licensed physician authorized to prescribe anesthetics? Are such prescriptions retained for three years for inspection?

Inspect the traditional Chinese medicine decoction room, conducting supervisory inspections on aspects such as equipment requirements, personnel qualifications, decoction methods, and decoction management.

(1) Supervision and inspection of equipment requirements

1. Does the hospital provide a decoction service for traditional Chinese medicinal herbs, and if so, are there appropriate facilities and equipment in place, with good sanitary conditions and adequate ventilation, temperature control, and refrigeration?

2. Is the traditional Chinese medicine decoction room (hereinafter referred to as the “decoction room”) located at a sufficient distance from various sources of contamination, and do the surrounding ground, road surfaces, vegetation, and other elements pose any risk of contaminating the decoction process?

3. Are the premises and floor area of the decoction room appropriately configured in accordance with the size of the medical institution and the volume of herbal decoctions prepared? Are the work area and living quarters segregated, and does the work area include designated functional zones for storage (of herbs), preparation, decoction, and cleaning?

4. Is the decoction room spacious and well-lit? Are the floor, walls, and ceiling smooth, clean, free from contamination, and easy to clean? Are there effective ventilation, dust-removal, water-accumulation prevention, and fire-protection systems in place? Do all piping, lighting fixtures, air vents, and other installations avoid creating hard-to-clean areas?

5. Is the herbal decoction room equipped with complete decoction equipment and facilities, and, as required by actual needs, also provided with medication storage facilities, refrigeration units, measuring cups (or cylinders), filtration devices, timers, medication storage containers, and medicine bottle racks, among others?

6. Ensure that the medicinal-decoction work surface is level and clean. Decoction vessels should be made of materials such as ceramic, stainless steel, or copper; the use of iron or other easily corroded containers is prohibited. Storage containers for prepared decoctions must be designed to prevent dust, mold, insects, rodents, and contamination. They must be thoroughly disinfected before use and promptly cleaned after use.

(2) Supervision and inspection of personnel requirements

1. Is the decoction room specifically managed by a Chinese medicinal pharmacist who possesses a certain level of theoretical knowledge and practical experience in operational procedures, responsible for providing professional guidance, quality supervision, and organizational management of the decoction room’s operations?

2. Are the personnel engaged in the decoction of traditional Chinese medicines trained in relevant knowledge and skills and have they passed the corresponding assessment? Are these personnel provided with planned on-the-job training in pertinent professional knowledge and operational skills?

3. Are herbal decoction personnel required to undergo an annual health examination? Individuals with infectious diseases, skin conditions, hepatitis B virus carriers, or open wounds on the body that have not yet healed are prohibited from performing herbal decoction duties.

4. Do the personnel preparing the herbal decoction observe proper personal hygiene? Are their hands cleaned before preparation, and are they wearing designated work uniforms while working, ensuring that these uniforms remain clean?

(3) Supervision and Inspection of Decoction Methods

1. Are oral medications and topical medications labeled differently to distinguish them?

2. The prepared herbal decoction must be transferred into containers that have been thoroughly cleaned and disinfected and meet food-contact standards to strictly prevent contamination.

3. Are the packaging materials and containers for decoctions of traditional Chinese medicinal herbs non-toxic, sanitary, resistant to breakage, and compliant with relevant regulations?

(4) Supervision and Inspection of Decoction Management

1. During the processes of dispensing, decocting, packaging, delivering, and administering herbal medicines, do the personnel involved meticulously verify the relevant information on the prescription (or decoction voucher), maintain accurate receipt and delivery records that are truthful and complete, and ensure that each batch (or formula) of decocted medicine is accompanied by an operational record documenting every step of the decoction process? Are these records kept neat and orderly, with accurate content and complete data?

2. Whether the emergency decoction of the medication is completed within 2 hours and whether the emergency decoction record is properly maintained.

3. Prior to use, are the decoction equipment, facilities, and containers thoroughly cleaned, and are there established cleaning procedures and daily cleaning records? Are the equipment and tools used for sweeping, washing, and disinfection stored in a dedicated area under proper custody? Is the decoction room regularly disinfected?

4. Strengthen quality control and monitoring of herbal decoction preparation. The head of the Pharmacy Department shall conduct regular (at least once per quarter) assessments and inspections of the quality of herbal decoction preparation, solicit feedback from healthcare personnel and inpatients, and establish quality control and monitoring records.

Traditional Chinese Medicine Technical Supervision

1. Are handwashing facilities, hand hygiene supplies, and hand-drying items provided, including running water, touch-free faucets, liquid hand soap, and no-rinse hand sanitizers? It is recommended to use single-use packaged hand soap; for refillable hand soap dispensers, are they cleaned and disinfected weekly?

2. Are handwashing flowcharts and instructional diagrams provided? Single-use paper towels are recommended for drying hands.

3. Whether healthcare personnel’s handwashing and hand disinfection, as well as the hand hygiene products used, comply with the requirements of the “Hand Hygiene Guidelines for Healthcare Personnel.”