Planning and DesignPlanning and design
Medical laboratory refers to the clinical testing of specimens from humans, including clinical blood and body fluid testing, clinical chemistry testing, clinical immunological testing, Medical institutions with independent legal person qualifications, including microbiological testing, clinical cell molecular genetics testing, and clinical pathological examinations.
I. Department Setting
Including clinical blood and body fluid examination, clinical chemistry examination, clinical immunoassay, clinical microbiological examination, clinical cytogenetics and clinical pathology. There are specialized departments or full-time personnel such as medical record information, reagents, quality and safety management, as well as auxiliary inspection departments and disinfection supply rooms (you can set up or entrust other medical institutions to undertake the corresponding services).
Medical test laboratory design
Houses and facilities
1. The use area of medical buildings is not less than 75% of the total area. The houses should have dual power supply or emergency power generation facilities, and important medical equipment and networks should have uninterruptible power supplies.
2. Set up a clinical examination specialty with a building area of not less than 500 square meters; set up more than two clinical examination majors with an increase of 300 square meters for each additional specialty construction area.
3. There is a corresponding work area, and the process should meet the needs of the work.
4. Set up a temporary storage place for medical waste and set up sewage and sewage treatment facilities and equipment to meet the requirements for disinfection and harmlessness of sewage and sewage.
1. Main business function area.
Set up business function areas including clinical blood and body fluids examination specialty, clinical chemistry examination specialty, clinical immunoassay specialty, clinical microbiology examination specialty, clinical cytogenetics specialty and clinical pathology specialty. It meets the requirements of biosafety management and hospital infection management, and strictly distinguishes clean areas, semi-polluted areas, and contaminated areas, and has complete biosafety facilities.
2, auxiliary function area.
Centralized power supply, water supply, disinfection supply room and others.
3. Management area.
Administrative (personnel, office, etc.), procurement, finance, quality assurance, logistics, information management and other departments.
1. Basic equipment.
Basic equipment, including refrigerators, centrifuges, samplers, pressure steam sterilizers, and biological safety cabinets, shall be appropriate to the inspection items and workload carried out. All inspection equipment, such as biochemical analyzer, blood cell analyzer, urine analyzer, microplate reader, luminescence analyzer, bacterial culture and identification instrument, nucleic acid analyzer, mass spectrometer, etc. Requirements related to medical device management announced by the General Administration of Supervision.
2. Pathological diagnostic equipment.
The number of conventional equipment such as centrifuges, samplers, disinfection equipment, biological safety cabinets, specimen cabinets, slicing cabinets, wax cabinets, general photography devices, digital slicing systems, and optical microscopes should be adapted to the business volume. At least one microscope for more than 5 people. Configure the corresponding number of molecular pathology diagnosis and technical equipment, such as PCR room and corresponding equipment, nucleic acid extraction equipment, molecular hybridizer, cryogenic centrifuge, fluorescence microscope, etc. Professional pathology equipment includes closed automatic dehydrator, wax block embedding machine, HE automatic staining machine, spreader, paraffin microtome, automatic liquid-based / thin-layer cell preparation equipment, frozen microtome (optional), Fully automatic immunohistochemical staining machines, etc., professional pathological equipment need to have the "national food and drug supervision" level medical device registration number.
3. Information equipment.
Information management systems such as network computers with information reporting and transmission functions, specimen management, and report management.
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