1. Laboratory Function Planning
(1) Zoning Design
① Sample Receiving and Pretreatment Area: Responsible for sample receiving, registration, sorting and pretreatment (such as centrifugation of serum), set up a dedicated sample transfer window, equipped with sample refrigerators, centrifuges and other equipment.
② Clinical Testing Area: Covers routine testing areas such as blood, body fluids, biochemistry, and immunology. Functional rooms are divided according to the characteristics of the test items, such as blood routine testing room, biochemical analysis room, etc., to ensure that each test process does not interfere with each other.
③ Molecular Diagnosis Area: Based on the nucleic acid testing process, it is divided into reagent preparation area, sample preparation area, amplification area and product analysis area. Each area is strictly physically separated and equipped with an independent ventilation system to prevent aerosol contamination.
④ Microbiological Testing Area: Set up sterile operation room, culture room, identification room, etc., equipped with biosafety cabinets, incubators, microbial identification systems, etc. to meet the needs of microbial culture, identification and drug sensitivity testing.
⑤ Special Testing Area: For special projects such as genetic testing and pathological diagnosis, set up independent functional areas, equipped with special instruments and protective facilities.
(2) Environmental control
① Use a professional ventilation system to ensure air circulation in all areas, especially in the molecular diagnosis area and microbial detection area, which must maintain a negative pressure environment to prevent the spread of harmful gases and microorganisms.
② Strictly control temperature and humidity, such as maintaining the temperature of the reagent storage area at 2-8°C to ensure the stability of the detection reagents, maintaining the temperature of the instrument area at 18-26°C and the humidity at 40%-65% to ensure the normal operation of the instrument.
2. Equipment and reagent configuration
(1) Core detection equipment
① Conventional testing equipment: hematology analyzer, urine analyzer, fully automatic biochemical analyzer, chemiluminescence immunoassay analyzer, used for blood routine, urine routine, biochemical indicators and immune project detection.
② Molecular diagnostic equipment: real-time fluorescence quantitative PCR instrument, nucleic acid extraction instrument, gene sequencer, to meet the needs of pathogen nucleic acid detection, gene detection, etc.
③ Microbial detection equipment: fully automatic microbial culture system, mass spectrometer, used for microbial isolation, culture and rapid identification.
(2) Auxiliary equipment.
① Sample storage equipment: ultra-low temperature refrigerators, liquid nitrogen tanks, for long-term storage of special samples and reagents.
② Consumables and reagents: According to the test items, disposable blood collection tubes, reaction cups, test kits and other consumables are equipped, and a strict reagent management system is established to ensure the quality and validity of the reagents.
3. Quality management system
(1) Standardized operating procedures: Develop standard operating procedures (SOPs) covering the entire process of sample collection, transportation, testing, and report review to ensure operational consistency and standardization.
(2) Quality control measures
① In-house quality control: Use quality control products for testing every day, draw quality control charts, and monitor the stability and accuracy of test results.
② Inter-laboratory quality assessment: Regularly participate in inter-laboratory quality assessment activities organized by national or provincial clinical laboratory centers, compare test results with other laboratories, and evaluate laboratory testing capabilities.
③ Personnel training and assessment: Regularly organize testing personnel to participate in professional skills training and assessment, including instrument operation, new method learning, quality control knowledge, etc., to ensure that personnel qualifications and capabilities meet the standards.
4. Safety Management Plan.
(1) Biosafety Protection
① Equip biosafety cabinets of corresponding levels according to the degree of biohazard, and operators must strictly wear protective equipment and standardize operating procedures to prevent biocontamination.
② Establish a biosafety management system, classify and collect infectious waste, and dispose of it as medical waste after high-pressure sterilization or chemical disinfection.
(2) Chemical and Radiation Safety: Implement double-person double-lock management for toxic and hazardous chemicals, and equip emergency eyewash stations, fume hoods and other protective facilities, for testing projects involving radioactive substances, set up special protection areas and equip radiation monitoring equipment.
5. Information Management System
(1) Laboratory Information Management System (LIMS): Realize the information management of the entire process including sample information, test data, instrument status, and personnel operation, improve work efficiency, and reduce human errors.
(2) Data Transmission and Sharing: Establish data interfaces with the hospital HIS system and physical examination center system to realize real-time transmission and sharing of test data, making it convenient for clinicians to quickly obtain test reports.
(3) Electronic Report and Query.