Abstract: In order to standardize the management of clinical gene amplification testing laboratories, to ensure the quality of clinical gene amplification testing, so that the clinical diagnosis and treatment of a more scientific and rational, the development of this approach.
Keywords: PCR laboratory
Interim Measures for Laboratory Management of Clinical Gene Amplification Tests
Chapter I. General Provisions
Article I. These measures are formulated to standardize the management of clinical gene amplification test laboratories, to ensure the quality of clinical gene amplification tests, and to make clinical diagnosis and treatment more scientific and rational.
Second, clinical gene amplification testing technology refers to clinical diagnosis and treatment for the purpose of amplification detection of DNA or RNA as a method of testing technology, such as polymerase chain reaction (PCR), ligase chain reaction (LCR), transcription-dependent amplification system (TAS) autonomous sequence replication system (3SR) and chain substitution amplification (SDA), etc..
Article 3 These measures apply to clinical gene amplification test laboratories. Clinical gene amplification test laboratories set up in hospitals above the second level.
Fourth, clinical gene amplification test laboratories must use clinical test reagents approved by the State Drug Administration to carry out clinical gene amplification test program.
Fifth, the Ministry of Health Clinical Laboratory Center (hereinafter referred to as the Ministry of Health Clinical Laboratory Center) and provinces, autonomous regions and municipalities directly under the Central Clinical Laboratory Center (hereinafter referred to as the Provincial Clinical Laboratory Center) is responsible for the jurisdiction of the administrative region of the clinical gene amplification test laboratory quality supervision and management work.
Chapter II laboratory set up and acceptance
Article VI to set up a clinical gene amplification test laboratory in accordance with the "Clinical Gene Amplification Test Laboratory Basic Setting Standards" (see Appendix) to build the laboratory; after the completion of the preparatory work, by the legal representative of the Ministry of Health Clinical Laboratory Center for the application for acceptance of the technology. Application to submit the following materials:
(a) "medical institutions license" copy;
(b) feasibility study report;
1, the proposed clinical gene amplification test laboratory institution of the location of the state of health care resources, the basic situation of the institution, the demand for clinical gene amplification test and the predictive analysis of the operation of the clinical gene amplification laboratory
2, the proposed clinical gene amplification test laboratory setup plan;
3, the proposed clinical gene amplification test laboratory will carry out the test, laboratory equipment conditions and relevant technical staff information
Article VII of the Ministry of Health Clinical Laboratory Center and the Provincial Clinical Laboratory Center*** with the organization of the relevant professional expert group (hereinafter referred to as the expert group), in accordance with the "Basic Setting Standards for Clinical Gene Amplification Test Laboratory", the "clinical gene amplification test laboratory". Amplification test laboratory in accordance with the "clinical gene amplification test laboratory basic setup standards" on the application of clinical gene amplification test laboratory for technical acceptance. After the acceptance is completed, the acceptance report will be sent to the applicant organization within 20 days.
Article VIII by the expert group technical acceptance of qualified medical institutions will be Article 6 of this approach to the materials and expert group acceptance report sent to the provincial Ministry of Administration for the record. In compliance with the provisions of all the materials sent to the provincial health administrative department within 15 days after the provincial health administrative department did not receive disapproval of the opinion, before carrying out the expert group technical acceptance of the clinical gene amplification test project.
Article IX without the acceptance of the expert group and reported to the provincial health administrative department for the record of the medical institutions shall not carry out clinical gene amplification test project.
Chapter III Laboratory Supervision and Management
The tenth clinical genetic testing laboratories must be in accordance with the "Clinical Gene Amplification Test Laboratory Work Specification" (issued separately) to carry out clinical gene amplification test work.
Order XI clinical gene amplification test laboratory technicians must undergo induction training. Qualified by the training, the training unit issued by the certificate of competency, and the list of qualified personnel will be reported to the Ministry of Health clinical testing center for the record. Obtained a certificate of training before engaging in clinical gene amplification test work.
The training unit for the Ministry of Health Pro-Test Center, or by the provincial health administrative departments designated by the Ministry of Health Pro-Test Center recognized institutions. Training in the use of uniform teaching materials.
Article XII of the gene amplification test for scientific research purposes. Test reports shall not be issued to the clinic, shall not charge any fees to patients.
Article XIII of the clinical gene amplification test laboratory must be in accordance with the "Clinical Gene Amplification Laboratory Code of Practice" to carry out indoor quality control, and to participate in the Ministry of Health Clinical Laboratory Center for the organization of indoor quality evaluation.
Article XIV of the Ministry of Health Provisional Inspection Center in accordance with this method and the "Clinical Gene Amplification Laboratory Code of Practice" to coordinate and organize the provincial Provisional Inspection Center of the clinical gene amplification test laboratory test quality monitoring. Monitoring results reported to the provincial health administrative departments, while copying the monitored clinical gene amplification test laboratory where the medical institutions.
Article XV of the Ministry of Health or provincial clinical testing center commissioned by the provincial health administrative departments can be on-site inspection of clinical gene amplification test laboratory, on-site inspection staff in the performance of their duties should be shown. On-site inspection, the inspector has the right to access the relevant information, the inspected organization shall not refuse or conceal.
Article XVI of the Ministry of Health Center for clinical gene amplification in the inter-room quality assessment failed to warn the clinical gene amplification test laboratories, the second consecutive or three times in the second found that the clinical gene amplification test results unqualified clinical gene amplification test laboratories, the Ministry of Health Center for clinical test reported to the provincial level or above by the provincial level or above by the provincial level or above of the administrative department of health ordered the suspension of clinical gene amplification test project, rectification within a certain period of time. Test project, a deadline for rectification. By the expert group to carry out another technical acceptance and qualified, and reported to the provincial health administrative departments for approval before re-opening the clinical gene amplification test project.
Article XVII of the Ministry of Health Center for clinical testing without the organization of the expert group technical acceptance and reported to the provincial health department for the record, without authorization to carry out clinical genetic testing of medical institutions, by the provincial administrative department of health based on the "Regulations on the Management of Medical Institutions," Article 47 and the "Rules for the Implementation of the Regulations on the Management of Health Care Institutions," Article 80 shall be punished, and shall be announced. The costs required for the announcement shall be paid by the announced organization.
Article XVIII of the following circumstances occur in the clinical gene amplification test laboratory, the provincial health administrative department ordered to stop carrying out clinical gene amplification test, and its medical institutions to be announced. Announcement of the costs incurred by the announcement of the institution to pay:
(a) beyond the Ministry of Health Clinical Inspection Center to carry out the organization's technical acceptance and reported to the provincial health administrative department for the record Clinical gene amplification test project;
(b) the use of reagents not approved by the State Drug Administration to carry out clinical gene amplification test;
(c) in the clinical gene amplification test without To carry out indoor quality control;
(d) in the clinical gene amplification test did not participate in the inter-room quality assessment;
(e) in the clinical gene amplification test fraud;
(f) for scientific research purposes of the gene amplification test project to collect fees from patients;
(g) the use of untrained professional and technical personnel to engage in clinical gene amplification test;
(g) use qualified professionals to engage in clinical gene amplification test;
(h) the use of the State Drug Administration approved reagents;
(c) in the clinical gene amplification test without Gene amplification test;