I, medical testing laboratory qualifications
Medical testing laboratory refers to the specimens from the human body for clinical testing and test results, with an independent legal person qualified medical institutions. Medical testing laboratories should be in line with the "basic standards for medical testing laboratories (for trial implementation)" and "Medical Laboratory Management Code (for trial implementation)", and in accordance with the relevant provisions of the management of medical institutions set up by the provincial health administrative department for approval, to obtain the "license to practice in medical institutions.
Medical testing laboratories without obtaining a "medical practice permit" without authorization or unauthorized trading, leasing, lending "medical practice permit" can be punished according to "Regulations on the Management of Medical Institutions".
"Medical institutions clinical gene amplification test laboratory management approach" Article 12 provides that medical institutions by the provincial health administrative department of clinical gene amplification test project registration, before carrying out clinical gene amplification test work. Medical testing laboratories to carry out new coronavirus nucleic acid amplification experiments, should be in accordance with the provisions of the clinical gene amplification program for the record and registration.
The unauthorized clinical genetic testing program of medical institutions, can be based on "clinical gene amplification test laboratory management of medical institutions," "Medical Institutions Regulations," Article 46 of the provisions of the penalties.
New coronary pneumonia as the implementation of Class A infectious diseases management of infectious diseases of Category B, to carry out viral culture, animal infection experiments should be carried out in biosafety level III laboratories, the third level of its laboratory should be through the National Laboratory Accreditation; to carry out uncultured infectious material operations (serology, nucleic acid extraction, etc.) should be carried out in the biosafety level II laboratories, the second level of biosafety laboratories should be Obtain the record voucher of the biosafety level II laboratory of the competent health department of the city in which the district is located.
Violation of the provisions of the laboratory does not meet the appropriate biosafety requirements to engage in experimental activities related to pathogenic microorganisms, may be ordered by the competent health department to stop the relevant activities, supervise the destruction of pathogenic microorganisms and give a warning of administrative punishment, suspected of committing a crime, shall be prosecuted according to law for criminal responsibility.
Second, the medical laboratory practitioner qualifications
Medical laboratory at least one with a deputy senior professional and technical title qualifications of clinical categories of practicing physicians;
clinical testing of various specialties at least five or more medical testing professionals and health professionals, of which there is at least one with more than associate, two intermediate professional and technical title qualifications. Qualified technicians. Specimen collection personnel should have the appropriate qualifications;
For medical testing laboratories to use non-health technicians engaged in medical and health technology, according to the "Regulations on the Management of Medical Institutions" or "Nurses Regulations" relevant provisions of the penalties.
Three, medical testing laboratory practice
Medical testing laboratory of the approved diagnostic and therapeutic subjects for medical testing, health administrative departments in the registration of medical testing diagnostic and therapeutic subjects, it should be clear that the medical testing department under the specialty.
Medical Laboratory Division, including clinical body fluids, blood; clinical microbiology; clinical chemistry; clinical immunology, serology; clinical cytomolecular genetics and others.
Medical testing laboratories without approval to carry out the new coronavirus nucleic acid detection test, according to the "Measures for the Management of Clinical Laboratories in Medical Institutions" and "Medical Institutions Regulations," Article 46 of the penalties.
Four, laboratory facilities and equipment and testing reagents management
Laboratory facilities management. Laboratory should be set up access control system, the entrance to set up a sign, a clear description of the level of biological protection, operation of the pathogenicity of biological factors, the name of the person in charge of the laboratory and cell phone; set up a video surveillance system; set up buffer room (semi-contaminated area), changing place (clean area), hand-washing facilities, autoclave sterilization area; to ensure that the various experimental areas, buffer areas of the exhaust airflow does not return or cascade.
Violation of the provisions of the relevant provisions of the "Pathogenic Microorganisms Laboratory Biosafety Regulations" for punishment.
Laboratory equipment management. Laboratory should be established and implemented in accordance with the provisions of the medical device purchase inspection record system, the use of qualified testing of the second level of biological safety cabinets (recommended use of type A2, B2), autoclave sterilization equipment, biological safety centrifuge and other equipment. Autoclave sterilization equipment needs to be evaluated by biological testing before activation, and can only be used after passing the evaluation; all equipment should undergo the necessary verification/calibration, and establish the procedure documents for the use, maintenance, verification and calibration of instruments and equipment, and strictly implement them in accordance with the procedure documents.
Violations can be penalized according to the relevant provisions of the "Regulations for the Supervision and Administration of Medical Devices" and "Measures for the Administration of Clinical Use of Medical Devices".
Laboratory reagent inspection: reagents should be matched with testing instruments, amplification kits should be selected from the State Drug Administration approved reagent kits with registration number, all reagents should be properly stored in strict accordance with the required conditions, and used within the validity period.
Violation of the provisions of the relevant provisions of the "supervision and management of medical devices regulations" for punishment.
V, medical paperwork management
Laboratories should establish a medical test report issuance system to ensure that medical test reports are accurate, timely and complete information, shall not issue false test reports.
Violation of the provisions of the "Regulations on the Management of Medical Institutions" Article 48 to be punished.
Based on the instructions of the amplification reagents used to determine the test results. Medical test report should be used in Chinese or international common, standardized abbreviations; medical test report or diagnostic report content should be in line with the "Basic Norms for the Writing of Medical Records" and other provisions, including at least
① checklist number, type of specimen, clinical diagnosis, test method, instrument type, mutual recognition of the project prompts;
② patient's name, gender, age, independent or its interlocking operation of the medical test laboratory name and address, telephone number for consultation;
③ other institutions to send specimens need to indicate the name of the sending institution, inpatient medical records or outpatient medical record number;
④ test items, test results and units of measure, reference interval (if applicable), critical value (if applicable), abnormal results prompt;
⑤ name of the test, the name of the examiner, the name of the reviewer, specimen collection time, Receiving time, reporting time, etc.
Failure to fill out the required medical record information, according to the "Basic Norms for the Writing of Medical Records" and "Regulations on the Prevention and Handling of Medical Disputes," Article 47 of the penalties.
VI, medical quality and safety management
1, medical testing laboratories should be ISO15189: 2012 as the standard for quality management, the establishment and implementation of medical testing quality management system, comply with the relevant technical specifications and standards, the implementation of pre-analytical, analytical, post-analytical three-stage quality management system, standard operating procedures for medical testing programs, standard operating and maintenance procedures for testing instruments. Operation and maintenance procedures, continuous improvement of test quality.
2, the laboratory should establish a detailed record of specimen receipt, preservation and transfer of destruction and disposal; specimen packaging containers outside the specimen with a unique number, type, name and sampling sealing bag (recommended biosafety markers) within the specimen collection and placed at room temperature for no more than 4 hours, the collection of the specimen, the delivery personnel and medical staff should check the specimen information one by one and do a good job of registering; specimens used for nucleic acid test Specimens for nucleic acid testing should be tested as soon as possible.
3, the laboratory should be in accordance with the provisions of the indoor quality control and inter-room quality evaluation activities.
Failure to develop and implement the core management system of medical quality and safety in accordance with the provisions of the Regulations on the Prevention and Handling of Medical Disputes can be dealt with in accordance with the provisions of the Regulations on the Prevention and Handling of Medical Disputes.
VII, test personnel training and protection
Medical testing laboratories should develop and implement staff pre-service training and rotational training programs and assessment. Test practitioners by the national or provincial clinical testing center clinical gene amplification test technology training (with a certificate); test personnel and specimen transport personnel by the laboratory where the organization's biosafety management committee designated personnel biosafety training and assessment of qualified; test personnel and specimen transport personnel by the laboratory where the relevant departments of the relevant departments of the personnel of the personal protective equipment wear training and related training and assessment of the abatement training Qualified; testing personnel by the laboratory of new coronavirus nucleic acid testing standardized operation training and assessment of qualified; wear N95 and above protective masks, goggles or face screen, one-piece protective clothing, medical protective cap, double-layer latex gloves, waterproof booties; if necessary, additional disposable waterproof isolation clothing, shoe covers. In case of contact with patient's blood, body fluids, secretions or excretions, the outer latex gloves should be changed promptly. For laboratories that do not have a dedicated testing area for specimens from suspected or confirmed cases, all personnel in the laboratory should be properly protected according to the above requirements.
Failure to regularly train staff in accordance with the provisions of the training, or staff assessment failed to allow them to work, or approval of unprotected personnel to enter the laboratory, or laboratory staff do not comply with the technical specifications of laboratory biosafety and operating procedures, can be dealt with in accordance with the "Microbiology Laboratory Biosafety Management Regulations".
VIII, medical waste disposal
The laboratory should be in accordance with the "Regulations on the Management of Medical Waste" and "Medical Waste Management Measures for Healthcare Institutions" relevant provisions of the proper disposal of medical waste. Laboratories carrying out experimental activities related to the new coronavirus should develop waste disposal program documents and operating procedures for the disposal of dirt and sewage. By properly trained personnel using appropriate personal protective equipment and equipment to deal with hazardous waste, infectious waste in the laboratory, should be standardized use of double yellow medical waste collection bag encapsulation, in accordance with the routine disposal process, the establishment of waste disposal records.
Violation of the regulations may be dealt with in accordance with the relevant provisions of the Regulations on the Management of Medical Waste