Article 22 of the medical institutions should strengthen the quality control and management of clinical laboratories.
Clinical laboratories in medical institutions should develop and strictly implement the standard operating procedures for clinical testing programs and testing instruments standard operating and maintenance procedures.
Article 23 of the clinical laboratory of medical institutions using instruments, reagents and consumables should be in line with relevant state regulations.
Article 24 of the clinical laboratory of medical institutions should ensure the integrity and effectiveness of the detection system, the need to calibrate the test instruments, test items and clinical test results have an impact on the auxiliary equipment for regular calibration.
Article 25 of the clinical laboratory of medical institutions should be carried out on the clinical testing program for indoor quality control, drawing quality control chart. Quality out of control phenomenon, it should be timely to find the cause, take corrective measures, and detailed records.
Article 26 of the clinical laboratory indoor quality control of medical institutions, including the selection of quality control products, quality control products, the number of quality control, quality control frequency, quality control methods, out of control judgment rules, out of control when the cause of the analysis and treatment measures, quality control data management requirements.
Article 27 of the clinical laboratory quantitative measurement of medical institutions, indoor quality control standards in accordance with the "clinical laboratory quantitative measurement of indoor quality control guidelines" (GB/20032302-T-361) implementation.
Article 28 of the clinical laboratory of the medical institutions should participate in the Ministry of Health recognized by the inter-room quality evaluation agency organized by the inter-room quality evaluation of clinical testing.
Article 29 of the clinical laboratory of medical institutions to participate in inter-laboratory quality assessment should be in accordance with the 5 routine clinical testing methods and clinical testing of specimens at the same time, shall not be another choice of testing system to ensure the authenticity of test results. Clinical laboratories of medical institutions for inter-room quality assessment of unqualified items, should promptly find the reasons, take corrective measures.
Medical institutions should be the bedside clinical testing programs and clinical laboratories with the same clinical testing program routine clinical testing methods for comparison.
Article 30 of the clinical laboratory of the medical institutions should not have carried out inter-room quality assessment of clinical testing projects and other clinical laboratories of the same type of project comparison, or other methods to verify the reliability of the results. Clinical test project comparison is difficult, the clinical laboratory of medical institutions should be evaluated on methodology, including accuracy, precision, specificity, linear range, stability, anti-interference, reference range, etc., and quality assurance measures.
Article 31 of the clinical laboratory of medical institutions in accordance with the standards of quality assessment of clinical laboratory inter-room quality assessment requirements "(GB/20032301-T-361) implementation.
Article 32 of the clinical laboratory of medical institutions should establish quality management records, including specimen receipt, specimen storage, specimen processing, instrumentation and reagents and consumables use, calibration, indoor quality control, inter-room quality assessment, test results, report issuance and so on. Quality management record-keeping period of at least 2 years. Article 33 medical institutions should strengthen the clinical laboratory biosafety management.
Medical institutions clinical laboratory biosafety management to strictly implement the "Pathogenic Microorganism Laboratory Biosafety Regulations" and other relevant provisions.
Article 34 of the clinical laboratory of medical institutions should be established and strictly abide by the biosafety management system and safe operating procedures.
Article 35 of the medical institutions should be clinical laboratory staff for pre-service safety education, and annual training in biosafety protection knowledge.
Article 36 of the clinical laboratory of medical institutions should be in accordance with relevant regulations, according to the risk of biological hazards, to ensure that the level of biosafety protection to achieve the appropriate level of biosafety protection.
Article 37 of the clinical laboratory of medical institutions should be in line with the relevant standards of architectural design, and its biosafety level of protection is appropriate.
Article 38 of the clinical laboratory of medical institutions should be in accordance with the level of biological protection with the necessary safety equipment and personal protective equipment to ensure that laboratory staff can be used correctly.
Article 39 of the collection of pathogenic microorganisms in medical institutions, transportation, storage, in strict accordance with the "Pathogenic Microorganisms Laboratory Biosafety Regulations" and other relevant provisions.
Article 40 of the clinical laboratory of medical institutions should be strict management of experimental specimens and experiments required bacteria (toxin) species, for highly pathogenic pathogenic microorganisms, in accordance with the "Pathogenic Microorganisms Laboratory Bio-safety Regulations," the provisions of the corresponding level of biosafety laboratories sent to the test.
Article 41 of the clinical laboratory of medical institutions should be in accordance with the relevant provisions of the Ministry of Health to strengthen the prevention and control of hospital infections.
Article 42 of the clinical laboratory of medical institutions should be in accordance with the "Regulations on the Management of Medical Waste" and "medical waste management in health care institutions," the relevant provisions of the proper disposal of medical waste.
Article 43 of the clinical laboratory of medical institutions should be developed biosafety accidents and dangerous goods, hazardous facilities and other accidents preventive measures and emergency plans. Article 44 medical institutions should strengthen the daily management of clinical laboratories.
Article 45 of the medical institutions have one of the following circumstances, by the local health administrative department above the county level in accordance with the "Regulations on the Management of Medical Institutions" shall be punished:
(a) not in accordance with the approved registration of medical testing under the professional diagnostic and therapeutic subjects to carry out clinical testing;
(b) in accordance with the relevant provisions of the unauthorized addition of new medical testing under the specialty;
(c) the medical laboratory shall be in accordance with the relevant provisions of the relevant regulations;
Article 46 of the Medical Laboratory of the United States, the medical institutions shall strengthen the daily management of clinical laboratories.
(C) beyond the scope of the registered specialty to carry out clinical testing.
Article 46 of the county-level health administrative departments shall be within the jurisdiction of the clinical laboratory management, quality and safety supervision and inspection, found that there are quality problems or safety hazards, should order the medical institution to immediately rectify.
Article 47 of the county-level health administrative departments receive reports on the clinical laboratory of medical institutions, complaints, should be promptly verified and dealt with according to law.
Article 48 of the county level above the health administrative department to carry out supervision and inspection duties, the right to take the following measures:
(a) on-site inspection of clinical laboratories in medical institutions, to understand the situation, investigation and evidence collection;
(b) access or copy of the clinical laboratory quality and safety management of the relevant information, collection, sealing samples;
(c) Order the violation of these measures and related provisions of the clinical laboratory of medical institutions and their personnel to stop illegal behavior;
(d) the violation of these measures and related provisions of the investigation and punishment.
Article 49 of the Ministry of Health can be entrusted to the Ministry of Health Clinical Laboratory Center and other relevant organizations8 on the quality of testing and safety management of clinical laboratories in medical institutions to carry out inspection and guidance. Provincial health administrative departments can be entrusted with the ability to evaluate the quality of inter-room provincial clinical testing centers or other relevant organizations within the jurisdiction of the clinical laboratory of medical institutions to inspect and guide the quality and safety management of testing.
Commissioned by the health administrative department of clinical testing centers or other organizations, in the inspection and guidance found that the clinical laboratory of medical institutions there are problems in the quality of testing and safety management, it should be commissioned to report to the health department in a timely manner, and put forward suggestions for improvement.
Article 50 of the health care institutions should be the health administrative department and its commissioned clinical testing centers or other organizations to carry out inspections of clinical laboratories and guidance to cooperate, shall not be refused and obstructed, shall not provide false information.
Article 51 of the provincial health administrative departments should be timely to the quality of clinical laboratories, safety management of medical institutions or announcements.
Provincial health administrative departments should be the previous year on the jurisdiction of the quality of clinical laboratories in medical institutions, safety management notification or announcement of the situation, on March 31 each year to the Ministry of Health.
Article 52 of the interlaboratory quality assessment agencies should be regular clinical laboratory interlaboratory quality assessment of medical institutions, to the Ministry of Health and for the issuance of the medical institution "medical practice license" of the health administrative department report.