Medical testing laboratories play a vital role in improving the medical service system, promoting the sharing of regional medical resources, improving the service capabilities of primary medical institutions, and promoting the construction of hierarchical diagnosis and treatment. Since this year, various health departments have approved the establishment of a large number of third parties. Medical laboratory.
What is a medical laboratory?
1. Medical testing laboratory refers to the purpose of providing information related to the diagnosis, management, prevention and treatment of human diseases or health assessment, which conducts clinical tests on specimens from human bodies, including clinical blood and body fluid tests, clinical chemistry tests, and clinical immune tests , Clinical microbiological examination, clinical cyto-molecular genetics examination and clinical pathological examination, etc., and issue examination results, medical institutions with independent legal personality qualifications.
2. The medical testing laboratory is a separate medical institution, which is an independent legal entity that independently assumes corresponding legal responsibilities, and is set up and approved by the provincial health and family planning administrative department.
3. The medical laboratory shall establish a cooperative relationship with general hospitals above the second level in the region, establish a green channel for emergency treatment of critically ill patients, strengthen technical cooperation, and continuously improve the technical level.
The medical laboratory is a medical institution with independent legal personality. This restriction is obviously inconsistent with the positioning of the hospital laboratory. Therefore, the medical laboratory is a third-party medical institution that independently assumes legal responsibility, not just a department of the hospital!
What are the necessary equipment for a medical laboratory?
The department settings of the medical laboratory should include: clinical blood and body fluid testing, clinical chemistry testing, clinical immune testing, clinical microbiological testing, clinical cyto-molecular genetics, and clinical pathology. There are special departments or full-time personnel for medical record information, reagents, quality and safety management, as well as auxiliary inspection departments and disinfection supply rooms (it can be set up or entrusted to other medical institutions to undertake corresponding services).
The equipment configuration of the medical laboratory includes three parts: basic equipment, pathological diagnosis equipment, and information equipment.
1. Basic equipment. Basic equipment including refrigerators, centrifuges, samplers, pressure steam sterilizers, biological safety cabinets, etc., should be adapted to the inspection items and workload carried out. All inspection equipment, such as biochemical analyzers, blood cell analyzers, urine analyzers, microplate readers, luminescence analyzers, bacterial culture and identification instruments, nucleic acid analyzers, mass spectrometry chromatographic analyzers and other inspection equipment should comply with the national food and drug The relevant requirements for medical device management announced by the State Administration of Supervision and Administration.
2. Pathological diagnosis equipment. The configuration of conventional equipment such as centrifuges, samplers, disinfection equipment, biological safety cabinets, specimen cabinets, slicing cabinets, wax block cabinets, general photography devices, digital slicing systems, optical microscopes, etc. should be adapted to the business volume. At least one viewing microscope for more than 5 people. Equipped with corresponding number of molecular pathology diagnosis and technical equipment, such as PCR room and corresponding equipment, nucleic acid extraction equipment, molecular hybridization instrument, cryogenic centrifuge, fluorescence microscope, etc. Professional pathology equipment includes a closed automatic dehydrator, wax block embedding machine, HE automatic staining machine, spreader, paraffin slicer, automatic liquid-based/thin-layer cell preparation equipment, cryostat (optional), Fully automatic immunohistochemical staining machines, etc., professional pathology equipment must have a medical device registration number at the "National Food and Drug Administration" level.
3. Information equipment. Network computers and other equipment with information reporting and transmission functions, specimen management, report management and other information management systems.