What Is a Clinical Laboratory Assistant?

In order to strengthen the management of clinical laboratories in medical institutions, improve the level of clinical testing, and ensure medical quality and medical safety, in accordance with relevant laws such as the "Law of Physicians", "Regulations on the Management of Medical Institutions" and "Regulations on the Management of Biosafety in Pathogen Microbiology Laboratories" 2. These regulations are formulated by laws and regulations.

Measures for the management of clinical laboratories in medical institutions

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In order to strengthen the management of clinical laboratories in medical institutions, improve the level of clinical testing, and ensure medical quality and medical safety, in accordance with relevant laws such as the "Law of Physicians", "Regulations on the Management of Medical Institutions" and "Regulations on the Management of Biosafety in Pathogen Microbiology Laboratories" 2. These regulations are formulated by laws and regulations.

Chinese name

Measures for the management of clinical laboratories in medical institutions

Types of

Management approach

in accordance with

Law of Practising Physicians

Purpose

Strengthen the management of clinical laboratories in medical institutions

Article 1 In order to strengthen the management of clinical laboratories in medical institutions, improve the level of clinical tests, and ensure medical quality and medical safety, in accordance with the "Law of Physicians", "Regulations on the Management of Medical Institutions" and "Regulations on the Management of Biological Safety in Pathogenic Microbiology Laboratories" And other relevant laws and regulations.

Article 2 The clinical laboratory of a medical institution referred to in these measures refers to the conduct of various specimens taken from the human body.

Article 6 When the administrative department of health approves the registration of medical examination departments of medical institutions, it shall clarify that there are specialties under the medical examination department.

Medical institutions shall set up clinical examination items and provide clinical examination services in accordance with the professional diagnosis and treatment subjects under the medical examination department approved and registered by the health administrative department. The newly-added medical laboratory section has a specialty or conducts clinical testing projects beyond the scope of the registered specialty, and it is necessary to go through the change registration procedures in accordance with the relevant provisions of the "Regulations on the Administration of Medical Institutions".

Article 7 The clinical testing services provided by clinical laboratories of medical institutions shall meet the needs of clinical work.

Article 8 Medical institutions shall ensure that the clinical testing work is objective and fair, and is not affected by any department or economic interests.

Article 9 Clinical laboratories of medical institutions shall be set up centrally, managed in a unified manner, and share resources.

Article 10 Medical institutions shall ensure that clinical laboratories are equipped with professional and technical personnel, places, facilities, and equipment suitable for their clinical testing work.

Article 11 The clinical laboratory of a medical institution shall establish, improve and strictly implement various rules and regulations, strictly abide by relevant technical specifications and standards, and ensure the quality of clinical tests.

Article 12 Professional and technical personnel in clinical laboratories of medical institutions shall have corresponding professional education and obtain corresponding professional and technical post qualifications.

The persons in charge of clinical laboratories of medical institutions at or above the second level shall undergo relevant training organized by the health administrative department at or above the provincial level.

Article 13 The clinical laboratory of a medical institution shall have full-time (part-time) personnel responsible for the quality of clinical tests and the safety management of clinical laboratories.

Article 14 The clinical laboratory of a medical institution shall carry out the clinical examination in accordance with the clinical examination items and clinical examination methods prescribed by the Ministry of Health.

Medical institutions may not use the clinical test items and clinical test methods announced by the Ministry of Health to stop clinical application for clinical test work.

The clinical test items and clinical test items for which clinical application is to be stopped will be announced separately by the Ministry of Health.

The Ministry of Health regularly releases new clinical testing items and clinical testing methods.

Article 15 The clinical laboratory of a medical institution shall have quality assurance measures before analysis, formulate standard operating procedures for patient preparation, specimen collection, specimen storage, specimen transport, and specimen reception, and shall be implemented by the medical institution.

Article 16 The clinical laboratory of a medical institution shall establish a system for issuing clinical test reports to ensure the accuracy, timeliness, and completeness of information in clinical test reports, and to protect patient privacy.

Article 17 The contents of the clinical test report shall include:

(1) Laboratory name, patient name, gender, age, inpatient medical record or outpatient medical record number.

(2) Reminder of inspection items, inspection results and units, reference range, and abnormal results.

(3) The name of the operator, the name of the reviewer, the time of receiving the specimen, and the time of reporting.

(4) Other contents to be reported.

Article 18 The clinical test report shall use Chinese or international abbreviations. The storage period shall be implemented in accordance with relevant regulations.

Article 19 The diagnostic clinical test report shall be issued by a practicing physician.

Diagnostic clinical test reports of clinical laboratories of medical institutions in townships, ethnic townships, and towns may be issued by licensed assistant physicians.

Article 20 The clinical laboratory of a medical institution shall provide interpretation and consultation services for clinical test results.

Article 21 Non-clinical laboratories shall not issue clinical test reports to the clinic and may not charge corresponding test fees.

Article 53 The meaning of the following terms in these Measures:

Inter-laboratory quality assessment uses laboratory-to-laboratory comparisons to determine laboratory testing capabilities.

Inter-laboratory comparison The organization, implementation, and evaluation of the same or similar test items performed by two or more laboratories in accordance with predetermined conditions.

In order to monitor and evaluate the work quality of the laboratory, the indoor quality control laboratory decides whether a series of inspection and control measures can be issued for the routine inspection report. Changes to improve the consistency of inter-assay and day-time specimen testing in the routine work of this room.

A quality control chart is a statistical method designed to measure and record the quality of a process to evaluate and monitor whether the process is in a controlled state.The chart has a centerline, upper and lower control limits, and has a chronological order. A sequence of trace points for the sampled statistic values.

Article 54 The management of special clinical examination items shall be separately stipulated by the Ministry of Health.

Article 55 The interpretation of these measures rests with the Ministry of Health.

Article 56 These Measures shall be implemented as of June 1, 2006. ^[1]