The full text is as follows:
Guidelines for the implementation of regional novel coronavirus nucleic acid detection organizations
(third edition)
In order to further guide the prevention and control of epidemic situation in COVID-19, ensure the completion of regional nucleic acid detection tasks with good quality and quantity within the specified time, and realize "early detection, early isolation, early diagnosis and early treatment", combined with previous practice, we revised the Implementation Guide for nucleic acid detection institutions in novel coronavirus (Second Edition) and formed the Implementation Guide for nucleic acid detection institutions in novel coronavirus (Third Edition).
I. General requirements
On the basis of accurate and rapid epidemiological investigation and community control, scientifically judge the risk of epidemic spread, delimit the scope of regional nucleic acid detection, formulate specific work plans, strengthen organization and management, optimize the collection, delivery, inspection and reporting processes, and further improve the quality and efficiency of nucleic acid detection. After the outbreak of COVID-19, the districts and cities where it is located, including megacities with a permanent population of100000, should complete the task of regional nucleic acid detection within 24 hours. If necessary, it can be guaranteed through regional cooperation; You can apply for state support if necessary.
Second, organization and management.
(1) Establish an organizational mechanism. Each district and city set up a working group for nucleic acid detection under the local joint prevention and control mechanism, led by the Standing Committee of the Municipal Party Committee, and organized health, public security, civil affairs, transportation, finance, Ministry of Industry and Information Technology, ecological environment, Party Committee Propaganda Department and other relevant departments to establish a flat working mechanism and start it urgently in case of an epidemic. Districts and cities should co-ordinate the regional nucleic acid detection work by units, grasp the overall situation of the jurisdiction, avoid simply dividing tasks and assign them to counties and districts.
(2) Work out a work plan. Districts and cities should formulate an operable regional nucleic acid detection work plan under the local joint prevention and control mechanism, clarify the division of responsibilities and responsible persons of relevant departments, rationalize the whole chain workflow, combine emergency with emergency, and carry out early warning screening drills in a timely manner.
(3) Set up special classes.
1. Special course on data statistics. Mainly responsible for the centralized management of data information generated by regional nucleic acid detection, establish a clear information flow process, and assign special personnel to be responsible for collection, statistics and reporting. The nucleic acid detection working group sends resident contacts to the detection institutions that undertake the task of regional nucleic acid detection, establishes a contact supervision mechanism between the data statistics class and the detection institutions, grasps the detection progress of each institution in real time, solves the problems encountered at any time, and urges the detection results to be uploaded in time.
2. Sampling and testing match special classes. Mainly responsible for formulating the matching scheme of sampling and testing according to the work plan of nucleic acid testing, and strengthening the dynamic command and adjustment of sampling and testing matching. It is necessary to accurately grasp the nucleic acid detection ability that can be used to mobilize the population base of the whole city and all streets (towns), communities and communities. In the process of regional nucleic acid detection, it is necessary to grasp the progress of collection, transportation and detection in real time to avoid uneven busy and idle time of detection institutions or backlog of samples.
3. Special category of sample transfer. Mainly responsible for scientific calculation of transport capacity demand, rational allocation of transport forces, close cooperation with sampling matching classes, and dynamic adjustment of sample transport schemes to ensure that all testing institutions enter the saturated working state at the fastest speed. The arrangement and deployment of transportation capacity should be optimized according to the number and distance of nucleic acid sampling points, the carrying capacity of transshipment vehicles and the time required for transshipment.
4. Special classes that handle positive results. Mainly responsible for the overall management of all positive results of nucleic acid detection (including positive results of single collection and mixed positive results of single collection) in epidemic-related cities, and quickly coordinate the completion of information flow, the review of single collection positive and the transfer of single collection positive personnel. The special class consists of 120 transshipment, public security, disease control and emergency sampling teams.
5. Material support special class. Mainly responsible for the estimation, storage and supply guarantee of all kinds of materials needed for regional nucleic acid detection, including detection materials, protective materials, transfer materials, disinfection materials and necessary living materials. And establish an effective calling mechanism to facilitate the management nearby. Among them, the consumables required for sampling are stored locally according to the local population, and the cities and counties are uniformly dispatched.
6. Special quality control category. Mainly responsible for the quality control of regional nucleic acid detection, set up nucleic acid sampling steering group and nucleic acid detection steering group to supervise and supervise the operation of sampling personnel, personal protection, quality control of laboratory detection and prevention and control of cross-infection at sampling points and laboratories. By strengthening quality control, we can minimize false negatives or false positives and put an end to the phenomenon of issuing false nucleic acid test reports.
7. Special medical waste treatment class. Mainly responsible for the management of the collection, temporary storage, transportation and disposal of medical wastes generated in all aspects of nucleic acid detection, and timely adjust the frequency of medical waste removal and centralized disposal according to the increase or decrease of medical wastes.
8. Specialized course of information security. Responsible for the operation and monitoring of the nucleic acid detection information system, timely handling information system failures, ensuring the safe operation of the system and avoiding problems such as downtime or system collapse; Do a good job in communication during nucleic acid detection.
9. Comprehensive management. Mainly responsible for writing regional nucleic acid detection work plan, nucleic acid detection analysis report, and comprehensive coordination and guarantee of each working class of nucleic acid detection working group.
According to the actual situation, according to the organization and mobilization, sample collection, specimen testing, order maintenance, biosafety, supervision and inspection, news and publicity, etc., the above nine special classes can be added or merged. Work needs, but the responsibility must be clear and implemented to everyone, and there can be no responsibility gap.
Third, the work content
(1) Find out the population base. All districts and cities implement the "four-party responsibility", establish work accounts, and find out the actual population base of streets (towns), communities and communities within their jurisdiction through grid management and dragnet investigation.
(2) Measuring sampling and testing ability. All districts and cities, regardless of population size, should match the sampling and testing strength according to the goal of completing the city's nucleic acid testing within 24 hours. Among them, in principle all sampling tasks should be completed within 6 hours; If it is really difficult, it can be completed within 12 hours. According to the standard that each sampling station (2 samplers) collects 120 people per hour, the calculation formula is: the number of nucleic acid samplers (unit: people) = population ÷ 360; If 10 and 1 mixed sampling detection technology are adopted, the calculation formula of detection ability is: nucleic acid detection intensity (unit: tube/day) = population10× 2; If 20-in- 1 mixed sampling detection technology is adopted, the calculation formula of detection ability is: nucleic acid detection intensity (unit: tube/day) = population ÷20×2.
(3) Refine the sampling plan.
1. Sampling point setting. The first is to scientifically plan sampling points. All districts and cities should comprehensively plan the layout of sampling points according to the distribution of population, geographical transportation and nucleic acid testing institutions. According to the sampling time of 6 hours per day, a sampling point can be set with reference to 2000-3000 people, and a sampling station can be set with reference to 600-800 people. Each sampling point needs 4-5 sampling stations (all localities can make overall plans according to the actual population situation of communities, streets, towns, rural areas and suburbs). In principle, sampling points can be set in communities. The second is to select sampling points scientifically. The sampling point should be an open, well-ventilated and relatively independent site, and venues such as gymnasiums, exhibition halls and school playgrounds with ventilation and independent space can be selected. Outdoor sampling points are encouraged when natural conditions permit. The third is to scientifically arrange sampling points. The sampling points are divided into waiting area, sampling area, buffer area, temporary isolation area and medical waste temporary storage area, which effectively disperses the population density to be tested. Set up a protective clothing wear-off area, equipped with hand hygiene facilities, mirrors or protective devices. The sampling point shall be provided with obvious guiding signs to ensure one-way flow of personnel, and the sampling process and matters needing attention shall be clearly defined. People over 60 years old, pregnant women and disabled people should set up green channels and conduct independent sampling. Special sampling points (sampling channels) should be set up for nucleic acid detection of health code "yellow code" personnel to avoid infection caused by personnel crossing. The fourth is to quickly build sampling points. The sampling points are required to be standardized and put into use within 2-4 hours. On the basis of fixed sampling points, the grid management mode is adopted, focusing on community sampling, and the layout is refined and improved by entering schools, enterprises and units to facilitate the sampling of the masses and improve the sampling efficiency.
2. Sampling organization. On the basis of grid management, strengthen the organization and mobilization of nucleic acid sampling, clarify the departments and personnel responsible for organization and mobilization, and standardize the organization and mobilization workflow. Take residential buildings, natural villages, schools, institutions, enterprises, companies, markets, hotels, etc. as examples. As the smallest unit, so as not to be short of households and people. Fine organization management should be strengthened in nucleic acid sampling site. While staff and volunteers maintain work order, physical means such as chairs and metal grid lines should be encouraged to strictly implement the "1 rice noodle" spacing requirement. By making an appointment in advance, notifying, sampling, etc., we will reduce the crowd gathering in a short time, and strive to queue up for no more than 20 minutes to avoid cross-infection.
3. Sampling method. Determine the sampling method according to the control measures taken by the target population. Centralized isolation points and other key populations are subject to single mining and single inspection; The population in the closed control area is subject to single sampling and single inspection or 1 household 1 tube; 10 and 1 mixed mining can be implemented in the control area; 20- 1 mixed mining can be implemented in the prevention area and other areas. In the case that no positive results are detected in several rounds of testing, the mixed sampling of 10 and 1 can be implemented as appropriate.
(4) Implement the sampling right. Prepare sampling medical personnel and information entry personnel in advance and conduct relevant training. On the basis of reasonable assessment of workload, each sampling station should be equipped with two sampling personnel (medical personnel, considering shift change) and 1 information entry personnel, and each sampling station should be equipped with 120 samples per hour. Sampling medical personnel should be familiar with the collection methods of nasopharyngeal and oropharyngeal swabs and receive strict personal protection and infection control training. Information entry personnel should be familiar with the operation process of nucleic acid detection information system and carry out relevant infection control training.
(5) sample storage and transportation. Test samples should be kept at low temperature (2-8 C). After the regional nucleic acid sampling 1 hour is started, the first batch of samples should be transported to the testing institution to start the operation of the testing institution. Subsequent samples can be collected and transported every half hour to two hours, and can be delivered to the laboratory 3 hours after the sample is collected. Give priority to the transfer of samples in the sealed control area and the control area, and ensure that they are transferred every 2 hours; Remote villages, mountainous areas and pastoral areas should reasonably determine the transshipment time and frequency according to specific conditions. It can be referred that the number of samples sent for inspection each time is about 10% of the single-day detection capacity of the testing institution, so as to carry out the testing in an orderly manner.
According to the actual demand, the sample transfer class estimates the number of special vehicles, personnel and transfer boxes needed for transfer, and reserves and calls the vehicles, personnel and transfer boxes. At the same time, it is necessary to file with the administrative department of health the situation of vehicles undertaking the task of regional nucleic acid detection and transshipment. During the transportation task, vehicles shall not be used for other purposes, and biological safety protection shall be done during transportation. The transportation of non-inactivated samples shall be approved by the health administrative department at or above the provincial level according to law. Public security, transportation and other departments should do a good job in transportation security according to actual needs.
Do a good job in personnel protection and disinfection of articles during the transfer of nucleic acid samples. Non-inactivated samples are packed with PI602 according to Class A infectious substances in the WHO Transport Guide for Infectious Substances, and inactivated samples are packed with PI650 according to Class B infectious substances in UN3373. Before closing the sample transfer box, the container surface must be disinfected with 75% alcohol or 0.2% chlorine-containing disinfectant.
(6) Strengthen information support.
1. Establish a nucleic acid detection information system. All provinces plan the construction of regional nucleic acid detection information system in districts and cities. The information system should realize fast and accurate entry of relevant information, including the information of the examinee (name, certificate type, certificate number, address and telephone number) and sampling information (name of sampling point, district and county, sample number, date and time of sample collection, collection place, type and quantity), and quickly feed back the information of the examinee suspected to be a positive sample. Realize the rapid, accurate and real-time monitoring of information collection, transmission, detection and reporting in nucleic acid detection, and realize the whole process management of nucleic acid detection. The information system can support multi-role, multi-user and high concurrent operation, and has the function of collecting, sending and viewing all kinds of information in real time. Before going online for use, according to the standard of completing the sampling of the actual management population 10% of the population every10 minute, carry out the stress test in advance to ensure the stability of the information system.
2. Do a good job of receiving, sending and inspecting the supporting equipment. Before starting the regional nucleic acid detection, the matching of collection, transportation and detection should be done well in advance, and dynamic scheduling should be carried out. First, according to the sampling ability of the set sampling points and the actual testing ability of each testing institution, the matching of dicing and sample delivery should be done in advance. Secondly, according to the experimental rhythm of nucleic acid detection institutions, batch samples are sent and dynamically scheduled, so as to achieve "no empty machines and no accumulated samples" and make full use of the detection capabilities of each detection institution.
3. Feedback of nucleic acid results. All districts and cities should feedback the results of nucleic acid testing in time, ensure the accuracy of information in all aspects of collection and inspection, provide the public with ways and means to inquire about the results of testing in time, and do a good job in the stress test of the inquiry service system in advance to ensure that the results can be inquired within 24 hours after sampling.
(seven) to ensure the supply of materials. In accordance with the principle of "it is better to be prepared than to use, and it is not available without preparation", before starting the regional nucleic acid detection work, the material support work should be done well in advance. Ensure the required sampling tubes (single tube, 10 to 1, 20 to 1, etc.). It is recommended to use inactivated sampling tubes), throat swabs (nasopharynx and oropharynx), detection reagents, medical consumables, protective articles, disinfection articles and other materials are in sufficient supply, with good quality, suitable models and specifications, and complete office supplies and necessary daily necessities. Special weather factors such as rain, snow, low temperature, high fever and typhoon should be fully considered in the material reserve of sampling points, and inventory and ledger reserve management should be carried out according to the layout of sampling points.
Fourth, scientifically determine the detection strategy.
The joint prevention and control mechanism of districts and cities should judge the epidemic spread trend according to the source of the epidemic and the push of close contacts, scientifically define the risk areas and the scope of nucleic acid detection in the areas and dynamically adjust them at the first time. In principle, 1 round of regional nucleic acid detection shall be conducted every day for the first 3 days after the outbreak to find out the potential social risks; Then, according to the comprehensive judgment of epidemic regulation and traceability, community control scope and nucleic acid screening results, the scope and frequency of follow-up screening are determined.
If the social risks are not controlled and the risk points are not clear, 1 round of regional nucleic acid detection will continue every day. Under the condition that social risks are controlled and risk points are basically found out, according to the distribution of cases, key areas can be divided according to relevant streets, communities and communities, and key areas can be inspected daily, while non-key areas can be inspected every other day or every three days according to the situation, and the test results can be issued within the specified time as required. Gradually narrow the scope of nucleic acid screening, improve the accuracy of screening, and achieve scientific and accurate screening.
All localities can promote the monitoring mode of "antigen screening and nucleic acid diagnosis" in combination with the relevant requirements of antigen detection in COVID-19, increase antigen detection as a supplementary means of regional nucleic acid detection, and organize the implementation after studying and refining the implementation plan.
Five, standardize the positive sample disposal process
(1) Disposal process of positive detection of apheresis. When the test result of a single sample is positive, the testing institution should immediately report it to the data statistics class of the nucleic acid testing working group, and the data statistics class will immediately notify the special class for the disposal of positive results, which will carry out the following five tasks: First, inform the 120 negative pressure ambulance to transport positive infected people; The second is to inform the centralized isolation management facilities to prepare for receiving positive infected people; The third is to inform the community (community) where the positive infected person is located to find and control the positive infected person; The fourth is to inform the public security organs to assist in the transfer of positive infected people and carry out follow-up investigation of positive infected people; The fifth is to inform the disease control department to carry out follow-up work such as flow tracing, unannounced visits and community control. The above-mentioned departments notified in no particular order.
(2) The treatment process of direct mixing mining test. Every city has set up an emergency sampling team, which is on standby 24 hours a day to make all preparations for departure at any time. When the mixed sampling test is positive, the testing institution shall immediately report to the nucleic acid testing working group, and the working group shall also notify the emergency sampling team, the community (district) where the mixed sample is located and the public security organ to immediately isolate the people involved and conduct a single sampling review. The re-examination of positive mixed sampling requires double sampling of nasopharynx and oropharynx. The re-inspection samples of single sampling shall be subject to the first inspection responsibility system and sent to the original laboratory for testing. If the re-inspection result of apheresis is positive, it will be processed according to apheresis detection processing flow. The active disposal of mixed mining test should be completed within 6 hours (see the figure below for details).
Frontal processing flow chart of mixed mining detection
Six, strengthen the quality control of nucleic acid detection
(1) Strengthen sampling quality control. The nucleic acid sampling supervision group guides each sampling point in the form of piecemeal contracts, standardizes sampling operation, personal protection and cross-infection prevention and control, guides each sampling point to maintain the order on site, strengthens the preservation management of collected samples, and ensures the high quality and high efficiency of sampling work.
(2) Strengthen testing and quality control. The nucleic acid detection supervision team established a casing supervision mechanism, and organized laboratory experts to conduct point-to-point casing supervision on various detection institutions. Laboratory performance verification, indoor quality control, and interventricular interstitial evaluation were carried out in accordance with the relevant requirements of novel coronavirus Nucleic Acid Detection Manual for Medical Institutions (Trial Second Edition) to ensure the detection quality. If the 20-in- 1 mixed sampling test is adopted for the first time, the training and implementation should be strengthened in accordance with the Technical Specification for COVID-19 nucleic acid 20-in- 1 mixed sampling test. Strict implementation of laboratory access and personnel access requirements, the development of laboratory standardization process to prevent laboratory pollution and cross-infection in the laboratory.
Seven, standardize personnel and other related management.
(1) Standardize the biosafety management of personnel and laboratories. All localities should, in accordance with the Biosafety Law, Regulations on the Biosafety Management of Pathogenic Microorganism Laboratories, and Guidelines on Biosafety of novel coronavirus Laboratories (Second Edition), make laboratory records as required, strengthen the biosafety management of laboratories, and prevent the occurrence of biosafety incidents. Strengthen the infection control training of medical personnel and other non-medical personnel, and the application training of regional nucleic acid detection information system. The protection requirements of sampling personnel and laboratory testing personnel shall be implemented in accordance with the Manual for Nucleic Acid Detection in novel coronavirus of Medical Institutions (Trial Second Edition). Local governments should do a good job in overall coordination, strengthen care for those involved in nucleic acid sampling and testing, and do a good job in logistics support.
(2) Strengthen the treatment of medical waste. All localities should standardize the management of medical waste, do a good job in the collection, packaging, harmless treatment, temporary storage, handover and transfer of medical waste, use double-layer packaging bags to contain medical waste, effectively seal it, and ensure that the packaging of medical waste is not damaged or leaked. The medical waste disposal special class shall timely coordinate the medical waste disposal units with corresponding qualifications to dispose of the medical wastes at the transfer sampling points and nucleic acid detection institutions. Medical wastes generated at nucleic acid sampling points should be removed on the same day; When temporary storage conditions permit, the temporary storage time of medical wastes generated by nucleic acid testing institutions shall not exceed 2 days. When the amount of medical waste increases sharply and cannot be stored safely, it should be removed on the same day. Nucleic acid detection institutions should make an appointment with the collection and transportation unit for removal time according to the temporary storage places and storage conditions of medical wastes, and the removal should avoid strong winds and thunderstorms. The collection and transportation unit shall optimize the dispatching of transportation vehicles, rationally arrange the collection and transportation routes, and do a good job in ensuring the removal and transportation of medical wastes.