Article VI of the administrative department of health in the approval of medical institutions in the medical laboratory diagnostic and therapeutic subject registration, should be clear that the medical laboratory under the specialty.
Medical institutions should be approved by the health administrative department in accordance with the registration of medical testing under the professional diagnosis and treatment subjects set up clinical testing programs, clinical testing services. New medical laboratory under the specialty or beyond the scope of the specialty has been registered to carry out clinical testing projects, should be in accordance with the "Regulations on the Management of Medical Institutions," the relevant provisions of the change registration procedures.
Article VII of the clinical laboratory of medical institutions to provide clinical testing services should meet the needs of clinical work.
Article VIII of the medical institutions should ensure that the clinical testing work objectively and impartially, without any sector, economic interests.
Article IX of the clinical laboratory of medical institutions should be set up centrally, unified management, resources **** enjoy.
Article X of the medical institutions should ensure that clinical laboratories have their clinical testing work appropriate professional and technical personnel, premises, facilities, equipment and other conditions.
Article XI of the clinical laboratory of medical institutions should establish and improve and strictly enforce the rules and regulations, strict compliance with relevant technical specifications and standards to ensure the quality of clinical testing.
Article XII of the clinical laboratory of medical institutions, professional and technical personnel should have the appropriate professional qualifications, and obtain the appropriate professional and technical qualifications.
Two or more medical institutions above the head of the clinical laboratory should be organized by the provincial health administrative department of the relevant training.
Article XIII of the clinical laboratory of medical institutions should have a full-time (part-time) personnel responsible for the quality of clinical testing and clinical laboratory safety management.
Article XIV of the clinical laboratory of medical institutions should be in accordance with the provisions of the Ministry of Health clinical testing programs and clinical testing methods to carry out clinical testing.
Medical institutions shall not use the Ministry of Health announced the cessation of clinical application of clinical testing programs and clinical testing methods to carry out clinical testing.
Clinical test items and stop the clinical application of clinical test items announced by the Ministry of Health separately.
The Ministry of Health regularly releases new clinical test items and clinical test methods.
Article XV of the clinical laboratory of medical institutions should have pre-analytical quality assurance measures, the development of patient preparation, specimen collection, specimen storage, specimen transport, specimen reception and other standard operating procedures, and implementation of the organization of medical institutions.
Article XVI of the clinical laboratory of medical institutions should be established clinical test report issuance system to ensure that the clinical test report is accurate, timely and complete information to protect patient privacy.
Article XVII of the clinical test report should include:
(a) the name of the laboratory, the patient's name, gender, age, inpatient or outpatient medical record number.
(b) test items, test results and units, reference range, abnormal results.
(C) operator's name, reviewer's name, specimen receipt time, report time.
(iv) other content to be reported.
Article 18 of the clinical test report should be used in Chinese or international common, standardized abbreviations. Retention period in accordance with relevant regulations.
Article 19 of the diagnostic clinical test report should be issued by a licensed physician.
Townships, ethnic townships, townships, clinical laboratories can be diagnostic clinical test report issued by a licensed physician assistant.
Article 20 of the clinical laboratory of medical institutions should provide clinical test results and consulting services.
Article 21 of the non-clinical laboratory shall not be issued to the clinical clinical test report, shall not charge the corresponding test costs.