Notice of the General Office of the National Health and Family Planning Commission on Issuing the Technical Management Specifications for Hematopoietic Stem Cell Transplantation (2017 Edition) and other 15 "restricted clinical application" medical technical management specifications and quality control indicators
National Health Office Medical Development (2017) No. 7
Health and Family Planning Commissions of all provinces, autonomous regions, and municipalities directly under the Central Government, and Health Bureau of Xinjiang Production and Construction Corps:
In order to further strengthen the supervision of the clinical application of medical technology during and after the event, do a good job in the management of the clinical application of "restricted clinical application" medical technology, standardize clinical behaviors, and ensure medical quality and medical safety, our committee has organized (revised) the "Hematopoietic Stem Cells" Transplantation Technology Management Regulations (2017 Edition) and other 15 medical technology management regulations that "restrict clinical application", and formulated quality control indicators for corresponding technologies (downloadable from the website of the National Health and Family Planning Commission). Is issued to you, please follow.
1. Technical management specifications for hematopoietic stem cell transplantation (2017 edition)
2. Quality control indicators for clinical application of hematopoietic stem cell transplantation technology (2017 edition)
attachment1
Technical management specifications for hematopoietic stem cell transplantation
(2017 version)
In order to standardize the clinical application of hematopoietic stem cell transplantation technology and ensure medical quality and medical safety, this specification is formulated. This specification is the minimum requirement for medical institutions and their medical staff to carry out hematopoietic stem cell transplantation technology.
This specification applies to the application of allogeneic hematopoietic stem cell transplantation technology to treat blood system diseases. The source of hematopoietic stem cells includes blood (HLA homologous or haploidentical) and non-blood donor bone marrow, peripheral blood or cord blood.
1. Basic requirements of medical institutions
(1) Medical institutions should carry out hematopoietic stem cell transplantation technologies that are compatible with their functions, tasks and technical capabilities, and have legal sources of hematopoietic stem cells.
(2) There are hematology or pediatrics and related professional diagnosis and treatment subjects approved and registered by the health and family planning administrative department.
(3) The department that develops hematopoietic stem cell transplantation treatment technology should meet the following conditions:
1. There are more than 4 beds in a hundred-level laminar flow ward, equipped with patient call system, ECG monitor, peripheral blood stem cell collection machine, flow cytometer, electric aspirator or central negative pressure suction system, and oxygen supply facilities.
2. If the adult hematology department develops children's hematopoietic stem cell transplantation technology, there should also be at least one pediatrician in this medical institution with the qualifications of associate chief physician or above.
3. Medical institutions should perform non-blood, umbilical cord blood or incompatible hematopoietic stem cell transplantation after completing 5 sibling fully identical allogeneic hematopoietic stem cell transplants.
(4) Other related departments.
1. For the development of hematopoietic stem cell transplantation technology, a laboratory with quality control and quality evaluation measures or a laboratory with a fixed cooperative relationship shall be able to perform hematopoietic stem cell activity detection, nucleated cell count, CD34+ cell count and HLA tissue matching, It has the ability to monitor the blood concentration of immunosuppressants. Related inspection items required for hematopoietic stem cell transplantation technology participate in the inter-office quality evaluation of the inter-office quality evaluation agency designated by the Health and Family Planning Commission at the provincial level and above and are qualified.
2. Have conditions and capabilities for microbiological testing and related diagnostic tests, hematology and pathology routine testing, cytogenetic analysis, or have a fixed cooperative relationship with laboratories that have the above conditions and capabilities.
3. When whole body radiotherapy (TBI) is used for pretreatment, there is a radiotherapy department or a radiotherapy department with a fixed cooperative relationship, which can implement fractional or single whole body radiotherapy, and can perform radiation dose measurement.
2. Basic personnel requirements
(1) Physicians who develop hematopoietic stem cell transplantation technology.
1. Obtain the "Physician's Practicing Certificate", and the scope of practice is the in-service physician of this medical institution who specializes in internal medicine or pediatrics.
2. Have more than 10 years of clinical diagnosis and treatment experience in the field of hematology or pediatrics, have participated in hematopoietic stem cell transplantation for more than 5 years, and have the ability to diagnose and treat complications of hematopoietic stem cell transplantation. The person in charge of the treatment of hematopoietic stem cell transplantation should also have the qualifications for professional and technical positions at or above the deputy chief physician. Physicians responsible for allogeneic hematopoietic stem cell transplantation shall have the qualifications for senior professional and technical positions.
3. After passing the training base designated by the provincial health and family planning administrative department on the related system training of hematopoietic stem cell transplantation technology, have the ability to carry out the clinical application of hematopoietic stem cell transplantation technology.
4. Departments with less than 10 beds in a hundred-level laminar flow ward should be equipped with more than 3 qualified practitioners who have been trained in hematopoietic stem cell transplantation technology, and nurses should be equipped with a nurse-to-bed ratio of 2:1; more than 10 beds in a hundred-level laminar flow The departments of the ward beds should be equipped with more than 5 qualified practitioners who have been trained in hematopoietic stem cell transplantation technology, and nurses should be staffed according to the nurse-to-bed ratio of 1.7:1.
(2) Other relevant health professional and technical personnel.
After hematopoietic stem cell transplantation treatment technology related professional system training, meet the relevant conditions required for the clinical application of hematopoietic stem cell transplantation treatment technology.
3. Basic requirements for technical management
(1) Strictly abide by the technical operating specifications and diagnosis and treatment guidelines for hematopoietic stem cell transplantation, and strictly control the indications and contraindications for hematopoietic stem cell transplantation.
1. Hematopoietic stem cell transplantation technology is suitable for the treatment of the following blood system diseases:
(1) Malignant diseases: acute leukemia, chronic leukemia, myelodysplastic syndrome, multiple myeloma, lymphoma and some other malignant tumors.
(2) Non-malignant diseases: aplastic anemia, severe radiation sickness, thalassemia major, etc.
2. The application of hematopoietic stem cell transplantation technology to treat some genetic diseases, congenital diseases and metabolic diseases shall refer to this regulation.
(2) Before performing hematopoietic stem cell transplantation, the patient and his family should be informed of the purpose of treatment, risks, precautions, and possible complications, and signed an informed consent form.
(3) Medical institutions should establish a complete clinical database and a strict postoperative follow-up system. After completing each hematopoietic stem cell transplantation, they should report the transplant related information to the health and family planning administrative department in accordance with relevant regulations.
(4) Technical requirements.
1. For bone marrow or peripheral blood stem cell transplantation, the number of mononuclear cells collected from the donor should meet the following standards: the number of bone marrow mononuclear cells ≥3×108/Kg, the number of CD34+ cells ≥2×106/Kg; peripheral blood mononuclear cells The number of cells≥5×108/Kg, and the number of CD34+ cells≥2×106/Kg.
2. The planned cord blood hematopoietic stem cell transplantation can use single or multiple cord blood, the number of single cord blood mononuclear cells> 2×107/Kg, and the number of CD34+ cells>1×105/Kg.
3. The implantation rate of 100 days after hematopoietic stem cell transplantation is ≥80%.
4. The incidence of acute graft-versus-host disease of grade Ⅲ-Ⅳ<30%.
5. The 1-year survival rate after 3 consecutive years of transplantation is ≥50%.
6. The 1-year survival rate of leukemia patients in the first remission stage after transplantation is >60%.
(5) Other management requirements.
1. Use equipment related to hematopoietic stem cell transplantation technology approved by the State Food and Drug Administration, and do not reuse disposable medical equipment related to hematopoietic stem cell transplantation technology in violation of regulations.
2. The source of hematopoietic stem cells is legal, non-blood bone marrow hematopoietic stem cells for transplantation should be provided by the China Bone Marrow Bank, and cord blood hematopoietic stem cells for transplantation should be provided by the cord blood hematopoietic stem cell bank approved by the National Health and Family Planning Commission.
3. Establish a registration system for the source of hematopoietic stem cells to ensure the traceability of the source of hematopoietic stem cells. Don't seek improper benefits through hematopoietic stem cell transplantation technology, and don't disclose the information of hematopoietic stem cell donors.
Four, training management requirements
(1) Training requirements for physicians who intend to carry out hematopoietic stem cell transplantation technology.
1. It should have a "Physician's Practicing Certificate", and have the qualifications of attending physicians and above for professional and technical positions.
2. Receive at least 6 months of system training. Under the guidance of the instructing physician, participated in the diagnosis and treatment of 2 patients with allogeneic hematopoietic stem cell transplantation, and participated in the whole process management of more than 5 patients with allogeneic hematopoietic stem cell transplantation, including indication selection, donor selection, preparation of pretreatment plans, Complication management, post-transplant management and follow-up, etc., and pass the assessment.
3. After receiving training in allogeneic hematopoietic stem cell transplantation technology for more than 6 months, with a training certificate from an overseas training institution, and passing the assessment of the training base designated by the provincial health and family planning administrative department, it can be deemed to have reached the required training Claim.
4. Before the issuance of this specification, have been engaged in clinical work for more than 15 years, have the professional qualifications of deputy chief physician, and have independently carried out clinical applications of hematopoietic stem cell transplantation technology in the past 3 years, and no less than 50 cases have occurred. Those who are mainly responsible for medical accidents related to hematopoietic stem cell transplantation are exempt from training.
(2) Training base requirements.
1. Training base conditions.
The provincial health and family planning administrative department designated a training base for hematopoietic stem cell transplantation technology. The training base should have the following conditions:
(1) A tertiary hospital that meets the technical management requirements of hematopoietic stem cell transplantation.
(2) The number of beds in a hundred-level laminar flow ward shall be no less than 10.
(3) In the past three years, no less than 150 cases of allogeneic hematopoietic stem cell transplantation have been completed, and no less than 50 cases of allogeneic hematopoietic stem cell transplantation have been completed each year.
(4) This medical institution has relevant laboratories and testing conditions for allogeneic hematopoietic stem cell transplantation.
(5) There are at least 4 instructing physicians capable of allogeneic hematopoietic stem cell transplantation, of which at least 2 are chief physicians.
(6) Have the personnel, technology, equipment and facilities suitable for the technical training of allogeneic hematopoietic stem cell transplantation.
(7) In the past 3 years, he has held a national professional academic conference related to hematopoietic stem cell transplantation technology or undertook a national continuing medical education project for hematopoietic stem cell transplantation technology.
2. Basic requirements for training.
(1) The training materials and syllabus meet the training requirements, and the curriculum includes theoretical study and clinical practice.
(2) Ensure that the trained physicians complete the prescribed training within the prescribed time.
(3) After the training is over, the trained physicians will be tested and assessed, and a conclusion on whether they are qualified or not will be issued.
(4) Establish training, examination, and assessment files for each trained doctor.
Annex 2
Clinical application of hematopoietic stem cell transplantation technology
Quality control index
(2017 version)
1. Compliance rate of indications for hematopoietic stem cell transplantation
Definition: The proportion of cases with correct indications for hematopoietic stem cell transplantation in the total number of hematopoietic stem cell transplantation cases during the same period.
Calculation formula:
=×100%
Significance: It reflects the degree of strict control of indications when medical institutions carry out hematopoietic stem cell transplantation technology. It is one of the important process indicators that reflect the medical quality of blood stem cell transplantation technology in medical institutions.
2. Implantation rate of allogeneic hematopoietic stem cell transplantation
Definition: within 100 days after allogeneic hematopoietic stem cell transplantation, the number of patients who achieved hematopoietic reconstitution (patient peripheral blood neutrophils>0.5×109/L and platelets>20×109/L) accounted for the same period of allogeneic hematopoietic stem cell transplantation patients The proportion of the total number of cases.
Calculation formula:
=×100%
Significance: One of the important indicators reflecting the technical level of blood stem cell transplantation in medical institutions.
3. The incidence of severe (Ⅲ-Ⅳ degree) acute graft-versus-host disease
Definition: Acute graft-versus-host disease (aGVHD) refers to the immune disease caused by graft-versus-host reaction within 100 days after hematopoietic stem cell transplantation, mainly manifested as rash, diarrhea and jaundice. It is an allogeneic hematopoietic stem cell transplantation The main complications and main causes of death. The incidence of severe (Ⅲ-Ⅳ) acute graft-versus-host disease refers to the number of patients with severe (Ⅲ-Ⅳ) acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation accounted for the same period of allogeneic hematopoietic stem cell transplantation patients The proportion of the total number of cases.
Calculation formula:
=×100%
Significance: It reflects the prevention level of aGVHD after different transplantation methods of hematopoietic stem cell transplantation by medical institutions. It is one of the important process indicators reflecting the medical quality of blood stem cell transplantation technology in medical institutions.
4. Incidence of chronic graft versus host disease
Definition: Chronic graft-versus-host disease (cGVHD) refers to a chronic immune disease caused by graft-versus-host reaction 100 days after hematopoietic stem cell transplantation. The incidence of chronic graft-versus-host disease refers to the proportion of patients with chronic graft-versus-host disease after allogeneic hematopoietic stem cell transplantation to the total number of patients with allogeneic hematopoietic stem cell transplantation during the same period.
Calculation formula:
=×100%
Significance: It reflects the level of cGVHD prevention by medical institutions after hematopoietic stem cell transplantation, and is one of the important process indicators reflecting the medical quality of blood stem cell transplantation technology in medical institutions.
5. Mortality related to allogeneic hematopoietic stem cell transplantation
Definition: The proportion of non-recurring deaths within 100 days after allogeneic hematopoietic stem cell transplantation to the total number of allogeneic hematopoietic stem cell transplantation patients during the same period.
Calculation formula:
=×100%
Significance: It reflects the comprehensive management level of medical institutions for patients after hematopoietic stem cell transplantation, and is one of the important outcome indicators reflecting the medical quality of blood stem cell transplantation technology in medical institutions.
6. Overall survival rate of allogeneic hematopoietic stem cell transplantation
Definition: The proportion of patients who survived allogeneic hematopoietic stem cell transplantation during the 1-year and 3-year follow-up after allogeneic hematopoietic stem cell transplantation.
Calculation formula:
=×100%
Significance: It reflects the technical level of blood stem cell transplantation in medical institutions, and is one of the important outcome indicators reflecting the medical quality of blood stem cell transplantation in medical institutions.
7. Disease-free survival rate of allogeneic hematopoietic stem cell transplantation
Definition: The proportion of patients who survived disease-free at 1-year and 3-year follow-up after allogeneic hematopoietic stem cell transplantation (listed as non-surviving patients) accounted for the total number of allogeneic hematopoietic stem cell transplant patients during the same period.
Calculation formula:
=×100%
Significance: It reflects the technical level of blood stem cell transplantation in medical institutions, and is one of the important outcome indicators reflecting the medical quality of blood stem cell transplantation in medical institutions.
8. Average hospital stay
Definition: The ratio of the total number of bed days occupied by patients undergoing allogeneic hematopoietic stem cell transplantation at the time of discharge to the number of discharged patients during the same period.
Calculation formula:
=
Significance: It reflects the efficiency of blood stem cell transplantation technology in medical institutions, and is one of the important outcome indicators reflecting the medical quality of blood stem cell transplantation technology in medical institutions.
9. Average hospitalization expenses
Definition: The ratio of the total hospitalization expenses of patients undergoing allogeneic hematopoietic stem cell transplantation at the time of discharge to the number of patients discharged from the hospital during the same period.
Calculation formula:
=
Significance: It reflects the socio-economic benefits of blood stem cell transplantation technology in medical institutions, and is one of the important outcome indicators reflecting the medical quality of blood stem cell transplantation technology in medical institutions.
10. Average hospitalized drug costs
Definition: The ratio of the total hospitalized drug costs of patients undergoing allogeneic hematopoietic stem cell transplantation at the time of discharge to the number of discharged patients during the same period.
Calculation formula:
=
Significance: It reflects the socio-economic benefits of blood stem cell transplantation technology in medical institutions, and is one of the important outcome indicators reflecting the medical quality of blood stem cell transplantation technology in medical institutions.
