Management standard management specification of neurovascular interventional diagnosis and treatment technology

In order to standardize the clinical application of neurovascular interventional diagnosis and treatment technology and ensure the quality and safety of medical treatment, this specification is formulated. This specification is the minimum requirement for medical institutions and their doctors to carry out neurovascular interventional diagnosis and treatment technology.

The neurovascular interventional diagnosis and treatment technology mentioned in this specification refers to the technology of diagnosis or treatment in the blood vessels of the head and neck and spinal cord through blood vessels or percutaneous puncture under the guidance of medical imaging equipment. (a) medical institutions to carry out neurovascular interventional diagnosis and treatment technology should be adapted to its functions and tasks.

(2) tertiary hospitals. There are medical subjects such as neurology, neurosurgery and medical imaging approved by the health administrative department, and there are interventional operating rooms (comparison rooms) and intensive care units.

1. Neurosurgery has no less than 30 beds, and has the conditions for microsurgery, and can independently carry out operations such as aneurysm clipping, vascular malformation resection and cerebral hemorrhage clearance.

2. Department of Neurology. No less than 40 beds.

3. Intervene in the operating room (contrast room).

(1) meets the radiation protection and aseptic operation conditions. Bacteria area, buffer area and aseptic area are clearly distinguished, and there is a separate dressing area and hand washing area.

(2) Equipped with digital subtraction angiography machine, which has the function of "road map" and has good image quality and radiation protection conditions; There is a medical image management system.

(3) Have the conditions of tracheal intubation and general anesthesia, be able to carry out cardiopulmonary and cerebral rescue and resuscitation, and have the necessary first-aid equipment and medicines such as oxygen supply system, anesthesia machine, defibrillator, aspirator and blood oxygen monitor.

(4) There is a storage cabinet for catheter, guide wire, contrast agent, embolic agent and other items and medicines, and there is a special person responsible for registration and storage.

4. Intensive care unit.

(1) The setting conforms to the requirements of relevant specifications, reaches the standard of Class III clean auxiliary rooms, with no less than 6 beds, and the net use area of each bed is not less than 15 square meters, which can meet the professional needs of neurovascular interventional diagnosis and treatment.

(2) Meet the treatment requirements of critically ill patients in neurology: equipped with multifunctional monitors and ventilators, which can monitor ECG, blood pressure and blood oxygen; Be able to carry out invasive intracranial pressure monitoring projects and invasive ventilator treatment; The hospital has measures and equipment to safely transport critically ill patients.

(3) Full-time doctors and nurses with professional training and more than 5 years of intensive care experience.

(3) Other relevant departments and equipment.

1. Medical imaging department can use Doppler ultrasound diagnostic instrument for routine and bedside cerebrovascular examination.

2. Have magnetic resonance imaging (MRI), computed tomography (CT) and medical image management system.

(4) Our hospital has at least two on-the-job doctors who have been formally trained and have the clinical application ability of neurovascular interventional diagnosis and treatment technology, and other professional and technical personnel who have been trained in neurovascular interventional diagnosis and treatment related knowledge and skills and adapted to neurovascular interventional diagnosis and treatment.

(five) to carry out neurovascular interventional diagnosis and treatment technology in secondary hospitals, in addition to meeting the above requirements, the following conditions shall also be met:

1. There is a need for neurovascular interventional diagnosis and treatment. The city divided into districts takes districts as units, and there are no medical institutions with technical qualifications for neurovascular interventional diagnosis and treatment in the region; When the county needs emergency neurovascular interventional diagnosis and treatment technology, it can't reach qualified medical institutions in time.

2. Send qualified personnel to a third-class first-class hospital with the technical qualification of neurovascular interventional diagnosis and treatment for at least 1 year long-term technical assistance and guidance. 1 year later, the provincial health administrative department will evaluate the clinical application ability.

(VI) The personnel, departments, equipment and facilities of newly-built or newly-established medical institutions with related specialties that intend to carry out neurovascular interventional diagnosis and treatment technology shall conform to this specification, and an application shall be submitted to the provincial health administrative department, which shall organize the evaluation of clinical application ability before it can be carried out. (1) Neurovascular interventional physician.

1. Obtained the certificate of medical practitioner, whose practice scope is surgery, internal medicine or medical imaging and radiotherapy.

2. Have more than 3 years experience in clinical diagnosis and treatment of neurology, neurosurgery or radiation intervention, and have the professional and technical post qualifications of attending physician or above.

Neurosurgeons should be trained in neurology, medical imaging and radiotherapy for at least 9 months each; Neurologists should be trained in neurosurgery, medical imaging and radiotherapy for at least 9 months each; Medical imaging and radiotherapy physicians need to be trained in neurosurgery and neurology for at least 9 months each.

3. The neurovascular interventional diagnosis and treatment training base recognized by the Ministry of Health has passed the systematic training and examination.

(2) Professional nurses and other technicians have received systematic training in neurovascular interventional diagnosis and treatment technology and passed the examination. (a) strictly abide by the technical operation specifications and diagnosis and treatment guidelines of neurovascular interventional diagnosis and treatment, comprehensively judge the treatment measures according to the patient's condition, optional treatment scheme, patient's economic affordability and other factors, rationally treat the disease, and strictly grasp the indications of neurovascular interventional diagnosis and treatment.

(2) Neurovascular interventional diagnosis and treatment should be decided by at least two neurovascular interventional physicians in our hospital, and the operator should be a neurovascular interventional physician in our hospital, and make a reasonable treatment plan and preoperative and postoperative management plan.

(three) before the implementation of neurovascular interventional diagnosis and treatment, patients and their families should be informed of the purpose of surgery, surgical risks, postoperative precautions, possible complications and preventive measures, and sign an informed consent form.

(four) establish and improve the follow-up system after neurovascular interventional diagnosis and treatment, and follow up and record according to the regulations.

(five) after the completion of neurovascular interventional therapy 10 working days, use the software specified by the Ministry of Health and submit relevant information to the Ministry of Health and the provincial health administrative department as required (notice will be issued separately).

(6) In principle, the number of cases of neurovascular interventional diagnosis and treatment completed by medical institutions every year is not less than 100, of which no less than 30 cases are treated. In medical institutions that carry out neurovascular interventional diagnosis and treatment every year, the incidence of serious complications related to interventional therapy should be less than 6% and the mortality should be less than 3%; If the number of cases treated is less than 100, the number of deaths related to interventional therapy operation shall not exceed 3 cases every year.

(seven) as an operator, a doctor with the technical qualification of neurovascular interventional diagnosis and treatment has completed not less than 30 cases of neurovascular interventional therapy every year.

(eight) the health administrative department at the provincial level shall announce to the public the list of medical institutions and doctors who are allowed to carry out neurovascular interventional diagnosis and treatment.

The provincial health administrative department shall regularly evaluate the clinical application of neurovascular interventional diagnosis and treatment technology of qualified medical institutions and doctors, including case selection, operation success rate, serious complications, death cases, medical accidents, postoperative patient management, average length of stay, patient's quality of life, patient satisfaction, follow-up and medical record quality. Medical institutions or doctors who fail to pass the examination shall be suspended from the clinical application qualification of relevant technologies and ordered to make rectification, and the rectification period shall not be less than 3 months. Only after the rectification meets the requirements can we continue to carry out related technologies; The medical institutions and doctors who failed to pass the evaluation for two consecutive times were rectified, and their clinical application qualifications of neurovascular interventional diagnosis and treatment technology were cancelled, and they were publicized to the public.

(9) Other management requirements:

1. Use neurovascular interventional diagnosis and treatment equipment approved by the drug supervision and administration department.

2. Establish a registration system for neurovascular interventional diagnosis and treatment equipment to ensure the traceability of equipment sources. The operation records of patients with neurovascular interventional diagnosis and treatment shall keep the bar code or other qualified documents of interventional diagnosis and treatment equipment.

3. Do not reuse disposable neurovascular interventional diagnosis and treatment equipment in violation of regulations.

4. Strictly implement the national price and financial policies and charge fees according to regulations. (a) before the implementation of this specification, doctors who meet the following conditions can carry out neurovascular interventional diagnosis and treatment without training and assessment:

1. Obtained the certificate of medical practitioner, whose practice scope is surgery, internal medicine or medical imaging and radiotherapy.

2. Have a good professional ethics, have a high level of professional skills identified by peer experts, and have been recommended by more than 3 chief physicians in this college, of which at least 1 is a doctor in other hospitals.

3. Have the qualifications for professional and technical positions above deputy chief physician.

4. Continuously engaged in clinical work of neurovascular interventional diagnosis and treatment for more than 10 years, and independently completed no less than 150 cases in recent 5 years; Or continuously engaged in the clinical work of neurovascular interventional diagnosis and treatment for 5- 10 years, and independently completed neurovascular interventional therapy for at least 300 cases in the past 5 years.

5. There were no medical accidents related to neurovascular interventional diagnosis and treatment in recent 3 years, the incidence of serious complications of angiography was less than 0.3%, and the mortality related to neurovascular interventional diagnosis and treatment was less than 3%.

(two) before the implementation of this specification, doctors who meet the following conditions can take the examination directly without training, and carry out neurovascular interventional diagnosis and treatment after passing the examination:

1. Obtained the certificate of medical practitioner, whose practice scope is surgery, internal medicine or medical imaging and radiotherapy.

2. Have a good professional ethics, have a high level of professional skills identified by peer experts, and have been recommended by more than 3 chief physicians in this college, of which at least 1 is a doctor in other hospitals.

3. He has been engaged in clinical work of neurovascular interventional diagnosis and treatment for more than 8 years, and has the professional and technical post qualification of attending physician or above. In recent 5 years, he has independently completed neurovascular interventional diagnosis and treatment surgery for not less than 150 cases.

4. There were no medical accidents related to neurovascular interventional diagnosis and treatment in recent 3 years, the incidence of serious complications of angiography was less than 0.3%, and the mortality related to neurovascular interventional diagnosis and treatment was less than 3%. Doctors who intend to engage in neurovascular interventional diagnosis and treatment should receive systematic training for not less than 12 months.

(1) The training base is recognized by the Ministry of Health and meets the following conditions:

1. a first-class hospital, and approved by the provincial health administrative department to carry out neurovascular interventional diagnosis and treatment technology.

2. The total number of beds in neurology, neurosurgery and neurovascular interventional department shall not be less than 150. The recognized diseases should include hemorrhagic, ischemic cerebrovascular diseases and spinal vascular diseases.

3. There shall be at least 3 instructors with technical qualifications for neurovascular interventional diagnosis and treatment, including at least 1 chief physician.

4. There are personnel, technology, equipment and facilities suitable for the training of neurovascular interventional diagnosis and treatment technology.

5. No less than 500 cases of neurovascular interventional diagnosis and treatment are completed every year, of which no less than 250 cases are treated; Or medical institutions continue to carry out neurovascular interventional diagnosis and treatment technology 10 for more than 0 years, and the cumulative number of cases treated is not less than 2000; In the past three years, at least 1 doctor independently completed neurovascular interventional therapy every year, with no less than 150 cases.

6. The academic level of related majors ranks among the top in China and has strong influence in the local area.

(2) Basic requirements of training.

1. Use the training syllabus and training materials uniformly compiled by the Ministry of Health.

2. Make a training plan to ensure that the trained doctors complete the required training within the specified time.

3. Regularly test and evaluate the theoretical knowledge and practical ability of the trained doctors during the training period as required; After the training, evaluate the trained doctors.

4. Establish training, examination and assessment files for each trained physician, and make attendance records.

5. Decide the number of doctors to be trained according to the actual situation and training ability.

(3) Training requirements for neurovascular interventional physicians.

1. Under the guidance of superior doctors, he participated in the completion of not less than 100 cases of diagnostic cerebrovascular and spinal angiography and not less than 50 cases of neurovascular interventional therapy. As an operator, he has completed not less than 40 cases of diagnostic cerebrovascular and myelography and not less than 20 cases of neurovascular interventional therapy, and passed the examination.

2. Under the guidance of superior doctors, participate in the whole process management of patients with neurovascular interventional diagnosis and treatment, including preoperative evaluation, interpretation of diagnostic examination results, consultation with other disciplines, neurovascular interventional diagnosis and treatment operation, record of interventional diagnosis and treatment operation process, perioperative treatment, intensive care treatment and postoperative follow-up.

3. Doctors who have been trained in neurovascular interventional diagnosis and treatment system abroad for more than 0/2 months and completed the prescribed number of cases have training certificates from training institutions and passed the examination, which can be regarded as meeting the prescribed training requirements.