Interim Measures for the Management of Clinical Gene Amplification Laboratory Chapter One total then First In order to standardize the management of clinical gene amplification test laboratories, ensure the quality of clinical gene amplification test, and make clinical diagnosis and treatment more scientific and reasonable, this method is specially formulated. Second The clinical gene amplification test technology refers to a detection technique for amplifying DNA or RNA for the purpose of clinical diagnosis and treatment , such as polymerase chain reaction ( PCR ), ligase chain reaction ( LCR ), transcription-dependent amplification system ( TAS ) autonomous sequence replication system ( 3SR ) and strand replacement amplification ( SDA ). Article 3 This method is applicable to laboratories performing clinical gene amplification tests. The clinical gene amplification test laboratory is established in the hospital above the second level. Article 4 Clinical gene amplification testing laboratories must carry out clinical gene amplification testing programs using clinical testing reagents approved by the State Drug Administration. The fifth The Clinical Inspection Center of the Ministry of Health (hereinafter referred to as the Procuratorate of the Ministry of Health) and the Clinical Testing Center of the province, autonomous region, and municipality directly under the Central Government (hereinafter referred to as the Provincial Procuratorate Center) are responsible for the quality supervision and management of the clinical gene amplification testing laboratory within the administrative area under its jurisdiction. . Chapter two Laboratory setup and acceptance Article 6 The medical institution that intends to set up the clinical gene amplification test laboratory shall prepare the laboratory according to the "Basic Setting Standards for Clinical Gene Amplification and Testing Laboratories" (see attachment); after the completion of the preparatory construction, the legal representative shall submit a technical acceptance to the clinical inspection center of the Ministry of Health. Application. The following materials must be submitted at the time of application: (1) A copy of the "Certificate of Practice for Medical Institutions"; (2) Feasibility study report; 1 , It is proposed to set the status of medical and health resources in the location of the clinical gene amplification test laboratory, the basic situation of the institution, the need for clinical gene amplification test, and the predictive analysis of the operation of the clinical gene amplification laboratory; 2 , It is proposed to set up a plan of the clinical gene amplification test laboratory; 3 , It is proposed to set up the inspection project, experimental equipment conditions and relevant technical personnel data to be carried out by the clinical gene amplification testing laboratory. Article 7 The Procuratorate of the Ministry of Health and the Provincial Procuratorate Center jointly organize expert groups of relevant disciplines (hereinafter referred to as the expert group), and carry out the technology of the applied clinical gene amplification testing laboratory according to the "Basic Setting Standards for Clinical Gene Amplification Testing Laboratories". acceptance. After the acceptance is completed, the acceptance report will be sent to the applicant organization within 20 days. eighth The medical institutions that have passed the technical inspection and acceptance of the expert group shall send the materials and expert group acceptance reports specified in Article 6 of the present Measures to the provincial administrative department for the record. After the compliance of all the materials served provincial health department has not received comments within 15 days provincial health department does not agree before the expert group to carry out technical acceptance of clinical gene amplification test items. Article 9 Medical institutions that have not been qualified by the expert group and reported to the provincial health administrative department for record shall not conduct clinical gene amplification test projects without authorization. third chapter Laboratory supervision and management Article 10 Clinical gene testing laboratories must carry out clinical gene amplification testing in accordance with the "Code of Practice for Clinical Gene Amplification Testing Laboratories" (sold separately). Article 11 Clinical gene amplification testing laboratory technicians must be trained. Those who have passed the training will be issued a certificate of conformity by the training unit, and the list of qualified personnel for training will be reported to the Procuratorate of the Ministry of Health for the record. Only those who have obtained the training certificate can engage in clinical gene amplification testing. The training unit is the inspection center of the Ministry of Health, or the institution designated by the provincial health administrative department and approved by the Ministry of Health. Use the prescribed uniform textbooks for training. Article 12 A gene amplification test project for scientific research purposes. No inspection report shall be issued to the clinic and no fees shall be charged to the patient. Article 13 The clinical gene amplification test laboratory must carry out indoor quality control in accordance with the "Clinical Gene Amplification Laboratory Work Specification" and participate in the indoor quality evaluation organized by the Ministry of Health's clinical inspection center. Article 14 According to this method and the “Code of Practice for Clinical Gene Amplification Laboratoriesâ€, the Ministry of Health of the Ministry of Health coordinates and organizes the provincial clinical inspection center to monitor the quality of the clinical gene amplification testing laboratory. The monitoring results are reported to the provincial health administrative department, and the medical institutions where the clinical gene amplification testing laboratory is monitored are copied. Article 15 The clinical inspection center of the Ministry of Health or the provincial-level clinical inspection center may be commissioned by the health administrative department at or above the provincial level to conduct on-site inspections of the clinical gene amplification testing laboratory. The on-site inspection staff shall present their credentials when performing their duties. When conducting on-site inspections, the inspectors have the right to access the relevant materials, and the inspected institutions may not refuse or conceal them. Article 16 The Clinical Inspection Center of the Ministry of Health has issued a warning to the clinical gene amplification testing laboratory that failed the inter-room quality evaluation. The clinical gene amplification test failed in the second or third consecutive clinical gene amplification test results. In the laboratory, the Ministry of Health's clinical inspection department reported that the health administrative department at or above the provincial level ordered the health administrative department at or above the provincial level to suspend the relevant clinical gene amplification test items and rectify within a time limit. After the technical inspection and acceptance by the expert group, and reported to the provincial health administrative department for approval, the clinical gene amplification test project can be re-launched. Article 17 For medical institutions that have not passed the technical acceptance of the expert group organized by the Ministry of Health of the Ministry of Health and reported to the provincial health department for the record, and carry out the clinical genetic testing project without authorization, the provincial health administrative department shall be based on the "Regulations on the Administration of Medical Institutions". Article 8 and Article 80 of the Regulations on the Administration of Medical Institutions shall be punished and announced. The fees required for the announcement are paid by the notified body. Article 18 The clinical gene amplification testing laboratory, which has one of the following conditions, is ordered by the provincial health administrative department to stop the clinical gene amplification test and announce the medical institution where it is located. The fees required for the announcement are paid by the notified body: (one) Carry out technical acceptance beyond the organization of the Ministry of Health's clinical inspection center and report to the provincial health administrative department for the record Clinical gene amplification test project; (two) Perform clinical gene amplification tests using reagents not approved by the State Drug Administration; (three) No indoor quality control was performed in the clinical gene amplification test; (four) Did not participate in inter-room quality evaluation in clinical gene amplification test; (Fives) Falsified in clinical gene amplification test; (six) The gene amplification test project for scientific research charges the patient; (Seven) Use unqualified professional technicians to perform clinical gene amplification tests; Chapter Four Attached then Article 19 The management of the gene amplification test project for the gene amplification test laboratory of the blood collection and supply institution shall be carried out with reference to the present Measures. Article 20 The expert group organized by the Procuratorate of the Ministry of Health shall carry out the technical examination and acceptance of the laboratories applying for clinical gene amplification testing in accordance with relevant state regulations. Article 21 The Ministry of Health is responsible for the interpretation of this measure. Article 22 These Measures shall be implemented as of the date of promulgation. Attachment: Basic setting standards for clinical gene amplification test laboratory Formulate this standard in accordance with the Interim Measures for the Administration of Clinical Laboratory Testing and Amplification Laboratory one, Clinical gene amplification test laboratory regional setting principle (one) Clinical gene amplification test laboratory regional setting principle 1 , Reagent storage and preparation area 2 , Specimen preparation area 3 , Amplification reaction mixture preparation and amplification zone 4 , Amplification product analysis area If a fully automated analyzer is used, the zones can be combined as appropriate. (two) Each work area must be clearly marked to avoid mixing equipment and items in different work areas. (three) Access to each work area must be carried out in strict accordance with a single direction, ie reagent storage and preparation area -> specimen preparation area -> amplification reaction mixture preparation and amplification area -> amplification product analysis area. (four) Different work areas use different work clothes (eg different colors). Work clothes should not be taken out when staff leave the work area. two, Work area equipment configuration standard (one) Reagent storage and preparation area 1 , 2 2 , the mixer 3 , micro sampler (covering 1-1000ul ) 4 , moving UV lamp (near work surface) 5 , consumables: disposable gloves, disposable absorbent paper, high pressure treated centrifuge tube and sampler tip (with filter) 6 , special overalls and work shoes 7 , special office supplies (two) Specimen preparation area 1 , 2 2 , high-speed desktop refrigerated centrifuge 3 , the mixer 4 , water bath or heating module 5 , micro sampler (covering 1-1000ul ) 6 , movable UV lamp (near work surface) 7 , ultra-clean workbench 8 , consumables: disposable gloves, disposable absorbent paper, high pressure treated centrifuge tube and sampler tip (with filter) 9 , special overalls and work shoes 10 , special office supplies If you need to deal with macromolecular DNA , you should have an ultrasonic water bath. (three) Amplification reaction mixture preparation and amplification zone 1 , Nucleic acid amplification instrument 2 , Micro sampler (covering 1-1000ul ) 3 , Movable UV lamp (near work surface) 4 , Consumables: disposable gloves, disposable absorbent paper, high pressure treated centrifuge tubes and sampler tips (with filter) 5 , Special overalls and work shoes 6 , Special office supplies ( 4 ) Amplification product analysis area Depending on the method of inspection. The basic equipment is as follows: 1 , Micro sampler (covering 1-1000ul ) 2 , Movable UV lamp (near work surface) 3 , Consumables: disposable gloves, disposable absorbent paper, sampler tips (with filter) 4 , Special overalls and work shoes 5 , Special office supplies Hydroxocobalamin Acetate Powder,Cyanocobalamin Raw Material,Methylcobalamin Raw Material,Biotin Vitamin Supplement Hunan Insen Biotech Co., Ltd , https://www.insenhealth.com
Basic equipment and requirements for the construction of PCR laboratories