Laboratory testing technicians should have a college degree or above in related majors or have intermediate or above professional and technical post qualifications, and have more than 2 years of laboratory work experience and relevant training certificates for genetic testing. The laboratory staff should adapt to the test items and the number of specimens, so as to ensure the timely and skilled experiment and report the results, and ensure the accuracy of the results.
Second, the specimen safety management
Before the specimen transfer box is closed, 75% alcohol or 0.2% chlorine-containing disinfectant must be sprayed for disinfection.
The packaging of samples shall meet the requirements of PI602 classified packaging in ICAO document Doc9284 "Technical Rules for Safe Aviation Transportation of Dangerous Goods". Involving the transportation of external specimens, it should be packed in three layers according to Class A infectious substances. Suspected or confirmed patient specimens should be marked with special signs and transported separately. If the test result is negative, the remaining samples and nucleic acids can be put into a special sealed waste transfer bag for pressure steam sterilization 24 hours after the result report is issued, and then transported out of the laboratory together with other medical wastes for destruction. If the test result is positive, the remaining samples should be rechecked and tested.
Three, laboratory testing safety management
1. Basic requirements
Specimen inactivation and detection should be carried out in the biosafety level II laboratory, and personal protection should be taken in the biosafety level III laboratory. Laboratories carrying out nucleic acid detection in COVID-19 should formulate laboratory biosafety related procedures and procedures for handling laboratory biosafety errors or accidents, and establish laboratory environmental disinfection records.
2. Safety requirements before the experiment
Desktop, countertop and floor should be disinfected with 0.2% chlorine disinfectant or 75% alcohol. Disinfectants should be freshly prepared every day for no more than 24 hours. The specimen transfer barrel transferred to the laboratory should be opened in the biosafety cabinet. After opening the transfer barrel, spray 0.2% chlorine-containing disinfectant or 75% alcohol on the inner wall of the transfer barrel and the sealed bag for sample collection for disinfection. After taking out the specimen collection tube, first check whether the outer wall of the specimen tube is damaged, whether the nozzle leaks or whether there is residual wall. After confirming that there is no leakage, it is recommended to spray and wipe the outer surface of the sterilized sample tube with 0.2% chlorine-containing disinfectant (75% alcohol is not recommended here to avoid damaging the sample identification). If leakage is found, it should be immediately covered with absorbent paper and disinfected by spraying chlorine-containing disinfectant with effective chlorine content of 0.55%. No further test operation shall be carried out on the sample. After the unqualified samples are recorded, they should be sealed and packaged immediately and destroyed after autoclaving.
Laboratory operators need to tighten the tube cover of the specimen collection tube before warm bath, and seal the tube cover with sealing film if necessary; In the process of warm bath, gently and evenly shake the specimen 1 time every 10 minute to ensure uniform inactivation of the specimen; After the warm bath, the sample should be allowed to stand at room temperature or at least 1. Omin to allow the aerosol to settle, and then the lid should be opened for subsequent nucleic acid extraction.
3. Safety requirements for nucleic acid extraction and detection
The nucleic acid extraction and detection of samples should be carried out in the biosafety cabinet as far as possible. If it is to open the specimen tube cover or other operations that may produce aerosol, it must be carried out in the biosafety cabinet.
4. Safety requirements after the experiment
The laboratory environment needs cleaning and disinfection.
(1) Laboratory air disinfection. After each test in the laboratory, the room should be disinfected by ultraviolet for 30 minutes or irradiated by ultraviolet sterilizer 1 hour. When necessary, reagents such as nucleic acid scavenger can be used in the laboratory to remove residual nucleic acid.
(2) Disinfection workbench. After the experiment every day, disinfect the countertops and floors with 0.2% chlorine-containing disinfectant or 75% alcohol.
(3) Disinfection of biosafety cabinets. The waste of consumables used in the experiment was put into the garbage bag of medical waste, and then the external surface was sprayed with 0.2% disinfectant or 75% alcohol containing available chlorine for disinfection. After hand disinfection, take the garbage bag out of the biosafety cabinet and put it into the laboratory waste transfer bag. Wipe the test tube rack, experimental table, pipette, etc. with 75% alcohol. Then close the biosafety cabinet and disinfect it with ultraviolet lamp for 30 minutes.
(4) Disinfection of transfer containers. The containers for transporting and storing specimens should be wiped or sprayed with 0.2% chlorine-containing disinfectant or 75% alcohol before and after use.
(5) Disinfection of plastic or plexiglass materials: wipe or spray disinfection with 0.2% chlorine-containing disinfectant or peracetic acid or hydrogen peroxide.
Four, laboratory medical waste management
1. Basic requirements
Laboratories conducting nucleic acid detection in COVID-19 should formulate medical waste treatment procedures and sewage treatment operation procedures. All hazardous medical wastes must be labeled completely and conform to the unified and standardized container and labeling methods. Hazardous medical wastes should be treated by properly trained personnel using appropriate personal protective equipment and equipment. The laboratory should establish medical waste treatment records, regularly remove and replace the HEPA filter exhausted from the laboratory, regularly monitor the treated sewage, and monitor the pressure sterilization effect with biological indicators.
2. Treatment measures of medical waste
The treatment of medical waste is the key link to control the safety of laboratory. We must fully grasp the classification of bio-safe waste and strictly implement the corresponding treatment procedures.
(1) waste liquid treatment
The waste liquid produced in the laboratory can be divided into ordinary sewage and infectious waste liquid. Hand-washing basin and other equipment produce ordinary sewage, which should be discharged into the laboratory water treatment system and discharged after unified treatment reaches the standard. Infectious waste liquid, that is, waste liquid generated during experimental operation, should be treated by chemical disinfection (0.55% chlorine-containing disinfectant) or physical disinfection (ultraviolet radiation for more than 30 minutes). It can only be discharged into the laboratory water treatment system after thorough disinfection and inactivation, and discharged after unified treatment reaches the standard. The disinfection effect of sewage was evaluated according to GB 18466 "Discharge Standard of Water Pollutants in Medical Institutions".
(2) Disposal of solid waste
Laboratory solid waste should be collected separately. The collection container of solid waste should have the characteristics of being not easy to crack, leakage-proof, moisture-proof, heat-resistant and sealed. The potentially infectious wastes in the laboratory are not allowed to be piled up and stored, and should be disinfected with pressure steam in time. Before waste treatment, it should be stored in a safe place designated by the laboratory. Small solid wastes, such as testing consumables and personal protective articles, need to be packaged and sealed with double-layer leak-proof special packaging bags, sterilized with pressure steam, and then transported out of the laboratory along the medical waste channel.
Large solid wastes, such as HEPA filters, should be disinfected by professionals on the spot and put into safe containers for disinfection and sterilization. Articles that cannot be sterilized by pressure steam, such as electronic equipment, can be fumigated with ethylene oxide. After disinfection and sterilization, the solid waste generated in the laboratory is handed over to the medical waste treatment unit for disposal.
Five, the treatment of laboratory pollution
1. When the specimen pollutes the operation table of biosafety cabinet, causing limited pollution, immediately cover it with absorbent paper and spray 0.55% chlorine-containing disinfectant for disinfection. Disinfectants need to be prepared now and used within 24 hours.
2. When the specimen capsizes and causes the laboratory pollution, keep the laboratory space airtight to avoid the diffusion of pollutants. Immediately cover the contaminated area with a towel dipped in 0.55% chlorine disinfectant. If necessary (e.g. when a large amount overflows), the laboratory can be heated and fumigated overnight with peracetic acid with a dose of 2g/m3; Or spray 20g/L peracetic acid disinfectant with an aerosol sprayer with a dose of 8m 1. /m3 is 1-2 hours; Fumigation with potassium persulfate-formaldehyde when necessary: put 8g/m3 of potassium persulfate into a heat-resistant and corrosion-resistant container (clay pot or glass container), and then add formaldehyde (40%) 65438+ 100m 1. /m3, fumigation for more than 4 hours. The indoor humidity during fumigation is 60%-80%.
3. When cleaning pollutants, adopt pressure steam sterilization in strict accordance with the biological safety operation requirements of live viruses, and ventilate the laboratory to prevent secondary hazards.
Six, the test results feedback requirements
1. reporting time limit
Report the results of nucleic acid detection within 6 hours for fever clinic and emergency patients; For general outpatients, inpatients and caregivers, the results should be reported within 12 hours in principle. For those who are willing to complete the inspection, the results will generally be reported within 24 hours. Medical institutions shall issue inspection reports for the subjects and inform them of the inquiry methods, and shall not refuse to issue inspection reports for any reason.
2. Experimental report
The test report shall be issued in accordance with the reference model of novel coronavirus nucleic acid test report, and the test results shall be mutually recognized in accordance with the provisions of the administrative department of health. Medical institutions can distribute nucleic acid detection reports in the form of paper, express delivery, network or information system, and pay attention to protecting personal privacy. When positive results of nucleic acid test are found, infectious disease report and subsequent epidemiological investigation shall be conducted within 12 hours according to relevant requirements.