In order to standardize the clinical application of tumor radiofrequency ablation therapy technology, improve the service level, ensure the medical quality and medical safety, and reduce various complications, this specification is hereby formulated. This specification is the basic requirement for medical institutions and their physicians to carry out tumor radiofrequency ablation therapy. Radiofrequency ablation therapy for tumors referred to in this specification refers to the local treatment technology that directly destroys tumors by physical methods, excluding microwave, laser, ultrasound, high-frequency electrocautery, refrigeration and other ablation therapy technologies. I. Basic requirements of medical institutions (1) Medical institutions shall carry out tumor radiofrequency ablation therapy technology, which shall be appropriate to their functions and tasks. 1. This technology is limited to be carried out in Grade 2A and above hospitals with relevant diagnostic and therapeutic subjects approved and registered by the health administrative department. 2. The applicant must have the ability to independently carry out gastrointestinal surgery, hepatobiliary surgery, thoracic surgery, general thoracic surgery, CT or ultrasound and other medical imaging guided liver puncture biopsy, lung puncture biopsy and other technologies. (II) Basic requirements for equipment 1. Medical institutions are required to have a tumor radiofrequency ablation equipment system approved by the State Food and Drug Administration for clinical treatment, which is currently available in the medical market, including Cool-tipRFSystem (Cold-circulation super-energetic radiofrequency tumor treatment system), RitaSystem (Rita Radiofrequency Liver Cancer Treatment System), RadioTherapeuticsSystem (Multi-bullet Radiofrequency Tumor Therapy System), etc. The components of RF ablation therapy instrument include radiofrequency generator, therapeutic electrodes and neutral electrode plate, and the main electrodes are: ① hollow cooling electrode; ② unfolded multi-coupling electrode; ③ perfusion electrode; ④ pulsed electrodes and so on. 2.With a special room for storing tumor RF ablation equipment and a cabinet for storing RF treatment needles and accessories, and a person is responsible for registering and keeping them. 3.Possess image-guided technical equipment, such as ultrasound, CT or MRI, etc. and medical image management system. And have the technical conditions of contrast-enhanced image examination for evaluating the local therapeutic effect. 4. Equipped with multifunctional monitors, capable of monitoring electrocardiogram, respiration, blood pressure, pulse rate and oxygen saturation during ablation; capable of cardiac, pulmonary and cerebral rescue and resuscitation, with necessary first-aid equipments and medicines, such as oxygen channel, anesthesia machine, defibrillator, suction device, and so on. 5.Carrying out the technology of radiofrequency ablation therapy for tumors in open surgery, and still need to have the technical equipment for image guidance in surgery. 6. To carry out laparoscopic tumor radiofrequency ablation therapy, it is necessary to have laparoscopic examination and treatment equipment, medical image graphic management system; special storage cabinets for storing laparoscopes and accessories, and a person in charge of registering and keeping them. 7.Possess operating room conditions required for tumor surgery, such as anesthesia monitoring system, other corresponding instruments and equipment. 8.Possess the operating room and other facilities corresponding to the development of the technology, and the sterilization and aseptic conditions should be in accordance with the corresponding management standards. Basic requirements of personnel There are at least 2 physicians with clinical application ability of tumor radiofrequency ablation therapy technology, and other professional and technical personnel who have been trained in the knowledge and technology related to tumor radiofrequency ablation therapy. (I) Tumor radiofrequency ablation physician 1, obtain the Physician Practice Certificate, the scope of practice is to carry out the application of this technology related to the specialty of the hospital’s registered physicians. 2.Tumor radiofrequency ablation technology training base recognized by the Department of Health of Zhejiang Province systematic training and qualified. 3. The personnel applying for independent operation of ultrasound-guided tumor radiofrequency ablation technology must have the qualification of attending physician or above, have more than 3 years of clinical experience in tumor diagnosis and treatment, and must be trained in ultrasound-guided tumor radiofrequency ablation technology and complete 15 cases of ultrasound-guided tumor radiofrequency ablation technology under the guidance of the supervising physician, and have no serious postoperative complications, and can only independently carry out the operation of B ultrasound-guided tumor radiofrequency ablation technology after passing the evaluation. Only after passing the evaluation can they independently carry out ultrasound-guided tumor radiofrequency ablation technology. 4. Those who apply for independent CT-guided tumor radiofrequency ablation must have the qualification of deputy chief physician or above, have more than 5 years of clinical experience in tumor diagnosis and treatment, and must be trained in CT-guided tumor radiofrequency ablation and have the basic concepts of tumor-free operation and aseptic operation as well as its basic techniques. And only after completing 15 cases of CT-guided tumor radiofrequency ablation technology operation under the guidance of superior physicians without serious postoperative complications and qualified by evaluation can they independently carry out CT ultra-guided tumor radiofrequency ablation technology. (II) Other health professionals and technicians (including image guidance, anesthesia and nurses) involved in tumor radiofrequency ablation treatment shall be required to go through the systematic training of knowledge and technology related to tumor radiofrequency ablation treatment. (a) Strictly abide by the technical operation standard of tumor radiofrequency ablation therapy and diagnosis and treatment guideline, correctly grasp the indications and contraindications of tumor radiofrequency ablation therapy, and decide on the comprehensive treatment plan based on comprehensive judgment of the patient’s condition, optional treatment means, and patient’s economic affordability. (ii) Implemented by physicians of this hospital who have the corresponding clinical application ability of tumor radiofrequency ablation therapy technology, and formulate reasonable treatment and management plans. (C) Before the implementation of tumor radiofrequency ablation therapy, the patients and their families shall be informed of the purpose of treatment, risks of treatment, precautions to be taken after treatment, possible complications and preventive measures, etc., and sign the informed consent form. (D) The percutaneous ablation process must be performed under image guidance and monitoring to improve the safety and reliability of the treatment. (E) After tumor radiofrequency ablation treatment, the condition should be closely observed and possible complications should be handled in a timely manner. (F) The technical evaluation and follow-up system of radiofrequency ablation of tumors should be established and improved, and records should be kept according to the regulations. (G) Medical institutions and physicians shall, in accordance with relevant regulations, regularly accept the assessment of clinical application capacity of tumor radiofrequency ablation therapy technology, including case selection, treatment success rate, serious complications, fatal cases, occurrence of medical accidents, post-treatment patient management, quality of patient survival, follow-up and quality of medical records. (viii) The medical institutions shall complete no less than 50 cases of tumor radiofrequency ablation treatment each year; there is no medical incident related to tumor radiofrequency ablation treatment. (IX) Other technical management requirements 1. Tumor radiofrequency ablation therapy equipment approved by the State Drug Administration shall be used. (2) Not to illegally reuse disposable tumor radiofrequency ablation therapeutic equipment, and not to seek improper benefits through the equipment. 3.Establish regular instrument and equipment testing, maintenance system and use of registration system. IV. Training The physicians to be engaged in tumor radiofrequency ablation therapy shall receive systematic training for at least 6 months. (A) training base designated by the Zhejiang Provincial Department of Health Administration, and has the following conditions: 1, Grade 3A hospitals. With medical oncology, surgical oncology, radiotherapy, ultrasound, radiology, general surgery, cardiothoracic surgery and other related departments. 2.Have the ability of clinical application of tumor radiofrequency ablation therapy technology, and complete no less than 60 cases of radiofrequency ablation therapy for various types of tumors every year. 3. The total number of beds for medical oncology and surgical oncology (or general surgery) and interventional therapy is not less than 150. 4.There are at least 4 instructors (including image-guided) with the ability of clinical application of tumor radiofrequency ablation treatment technology, of which at least 1 is the chief physician. 5.There are conditions such as personnel, technology, equipment and facilities that are suitable for carrying out tumor radiofrequency ablation therapy training work. 6. Carry out clinical application of radiofrequency ablation therapy for tumors for more than 5 years. (II) Basic requirements of training bases 1. The training materials and training syllabus are recognized by the Department of Health of Zhejiang Province. 2.To ensure that the trained physicians complete the required training within the stipulated time. 3, after the end of training, the physicians receiving training for the examination, assessment, and issue a qualified conclusion. 4.Establish training and examination and assessment files for each trained physician. 5. Decide the number of physicians to be trained according to the actual situation and training capacity. (C) Clinical application of tumor radiofrequency ablation therapy training requirements of physicians 1. Under the guidance of higher-level physicians, participate in the completion of no less than 15 cases of tumor radiofrequency ablation therapy, and pass the examination. 2.Under the guidance of superior physicians, they shall participate in the whole process of management of tumor radiofrequency ablation therapy patients, including preoperative evaluation, interpretation of diagnostic test results, joint consultation with other disciplines, tumor radiofrequency ablation therapy operation, tumor radiofrequency ablation therapy process records, perioperative treatment, intensive care treatment and post-operative follow-up. (3) Physicians who have received tumor radiofrequency ablation therapy system training outside the province for more than 6 months and have completed the number of prescribed cases, with training certificates from the training institutions, and have passed the examination and assessment of the training base, can be recognized as having met the stipulated training requirements. V. Other management requirements (1) Physicians who have the following conditions before the implementation of this specification can carry out tumor radiofrequency ablation therapy without training and evaluation of clinical application ability of tumor radiofrequency ablation therapy technology: 1. High professional ethics, high professional and technical level of peer experts’ evaluation, and obtaining the recommendation of more than two chief physicians of this specialty, of which at least one is a physician of the outside hospital. 2, continuously engaged in clinical work of tumor radiofrequency ablation therapy in tertiary hospitals for more than 5 years, with the qualification of professional and technical position of deputy chief physician or above. 3.Tumor radiofrequency ablation treatment has been completed independently for more than 100 cases in the past 5 years, and there has not been any medical incident related to tumor radiofrequency ablation treatment at level 2 or above, and the complication rate is less than 0.5%, and the mortality rate related to tumor radiofrequency ablation treatment is less than 0.1%.