Chinanews.com, March 22. According to the official website of the National Health and Medical Commission, the State Council's Comprehensive Team of the Joint Prevention and Control Mechanism for Novel Coronavirus Pneumonia Outbreaks has issued the Implementation Guide for Regional Novel Coronavirus Nucleic Acid Testing Organizations (Third Edition), requiring new coronary pneumonia After the outbreak, cities with districts, including megacities with a permanent population of more than 10 million in urban areas, should complete the designated regional nucleic acid testing tasks within 24 hours.

When necessary, it can be guaranteed through cooperative support within the region; when necessary, it can apply for national support.

  In order to further guide local governments to do a good job in regional new coronavirus nucleic acid detection work, on the basis of fully summarizing practical experience, the Comprehensive Team of the Joint Prevention and Control Mechanism of the State Council has conducted a "Guidelines for the Implementation of New Coronavirus Nucleic Acid Detection Organizations for All Staff (Second Edition)". It has been revised and improved, and the "Regional Implementation Guide for Novel Coronavirus Nucleic Acid Detection Organizations (Third Edition)" (hereinafter referred to as the "Guide") has been formed.

  The third edition of the "Guide" pointed out that on the basis of accurate and rapid flow investigation and strict community management and control, it is necessary to scientifically study and judge the risk of epidemic transmission, delineate the scope of regional nucleic acid testing, and formulate specific work plans to further improve the quality and efficiency of nucleic acid testing.

The key revisions are as follows:

  The first is to emphasize scientific precision and carry out nucleic acid detection in delineated areas.

In order to further improve the level of scientific and precise prevention and control, the third edition of the "Guide" puts more emphasis on the accurate delineation of the detection range on the basis of scientific research and judgment of the epidemic situation. The size of the area is determined by the needs of epidemic prevention and control, and guides localities to complete nucleic acid testing in the designated areas.

  The second is to further clarify the time limit for completion.

In order to adapt to the characteristics of the rapid spread of new coronavirus variants such as Omicron, it is stipulated that the nucleic acid detection of the designated scope should be completed within 24 hours, which further improves the ability of "early detection" of the epidemic.

  The third is to add a number of special work classes.

According to the various links and departments involved in the regional nucleic acid testing, the local government was instructed to set up 9 special classes for data statistics, special classes for collection and inspection matching, and the responsibilities of the special classes were specified.

The nine special classes are not required to be established, and localities can flexibly add or merge them according to the actual situation, but the responsibilities must not be vacant.

  The fourth is to provide the basis for measuring the strength of detection.

In order to facilitate local calculation and preparation of testing forces, on the basis of fully summarizing the experience of Xi'an, Tianjin and other places, clear guidance on the number of sampling personnel and nucleic acid testing capabilities required to complete nucleic acid testing within 24 hours is given.

  Fifth, simplify the technical requirements for testing.

Combined with the scope of application of this "Guide" and the actual operation requirements, the existing requirements in technical documents such as the "Work Manual for Novel Coronavirus Nucleic Acid Detection in Medical Institutions (Trial)" are not expressed in the text.

Instead, the management requirements for the organization, transport, detection, and result disposal of sampling are further highlighted and clarified.

Here is the full text:

Implementation Guidelines for Regional Novel Coronavirus Nucleic Acid Detection Organizations

(Third Edition)

  In order to further guide all localities to do a good job in the prevention and control of the new crown pneumonia epidemic, ensure that the regional nucleic acid detection tasks are completed within the specified time with quality and quantity, and achieve "early detection, early isolation, early diagnosis, and early treatment", combined with previous practice, we The "Guidelines for the Implementation of New Coronavirus Nucleic Acid Detection Organizations for Staff (Second Edition)" were revised to form the "Regional Implementation Guidelines for New Coronavirus Nucleic Acid Detection Organizations (Third Edition)."

  1. General requirements

  On the basis of accurate and rapid flow investigation and community management and control, scientifically study and judge the risk of epidemic transmission, delineate the scope of regional nucleic acid testing, formulate specific work plans, strengthen organizational management, optimize the process of collection, delivery, inspection, and reporting, and further improve the quality of nucleic acid testing and efficiency.

After the outbreak of the new crown pneumonia, the city divided into districts, including the megacities with a permanent population of more than 10 million in the urban area, should complete the designated regional nucleic acid testing tasks within 24 hours.

When necessary, it can be guaranteed through cooperative support within the region; when necessary, it can apply for national support.

  2. Organizational management

  (1) Establish an organizational mechanism.

Districts and cities set up a nucleic acid detection working group under the local joint prevention and control mechanism, led by the Standing Committee of the Municipal Party Committee, and organized relevant departments such as health, public security, civil affairs, transportation, finance, industry and informatization, ecological environment, party committee propaganda departments, etc. Linkage, establish a flat working mechanism, and activate it urgently when an epidemic occurs. Take districts and cities as units to coordinate the regional nucleic acid testing work, grasp the overall situation of the jurisdiction, and avoid assigning tasks to counties and districts.

  (2) Develop a work plan.

Under the local joint prevention and control mechanism, the city divided into districts shall formulate an operable regional nucleic acid detection work plan, clarify the division of responsibilities and persons in charge of each relevant department, straighten out the whole chain work process, combine peace and emergency, and carry out early warning screening in a timely manner drill.

  (3) Set up special classes for work.

  1. Data statistics special class.

Mainly responsible for unifying the data and information generated by nucleic acid testing in the centralized management area, establishing a clear information flow process, special personnel for collection, special personnel for statistics, and special personnel for reporting.

The nucleic acid testing working group dispatched a liaison to each testing institution that undertakes regional nucleic acid testing tasks, established a contact supervision mechanism between the data statistics special class and testing institutions, and kept abreast of the testing progress of each institution in real time. problems, supervise the timely upload of test results, etc.

  2. Matching special classes for collection and inspection.

Mainly responsible for formulating a collection and inspection matching plan according to the nucleic acid detection work plan, and strengthening the dynamic command and adjustment of collection and inspection matching.

It is necessary to accurately grasp the nucleic acid detection capabilities available for mobilization in the city and the population base of each street (township), community, and community. In the process of regional nucleic acid detection, the progress of collection, delivery, and inspection should be grasped in real time to avoid uneven busyness of testing institutions or samples. Backlog.

  3. Special class for sample transfer.

It is mainly responsible for scientifically calculating transport capacity requirements, rationally deploying transport forces, closely cooperating with the special class for collection and inspection, and dynamically adjusting the sample transport plan to ensure that each testing institution enters a 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 the transfer vehicle, and the time required for the transfer.

  4. A special class for disposal of positive results.

Mainly responsible for coordinating and managing the disposal of all positive nucleic acid test results in epidemic-affected cities (including positive apheresis and mixed positive), quickly coordinating the completion of information flow, apheresis review of mixed positive results, and transfer of apheresis positive personnel.

The special class is composed of 120 transfer, public security, disease control and emergency sampling teams.

  5. Special class for material security.

Mainly responsible for the estimation, reserve and supply guarantee of various materials required for regional nucleic acid testing, including testing materials, protective materials, transfer materials, disinfection materials and necessary living materials, etc., and establish an effective transfer mechanism to manage nearby .

Among them, the consumables required for sampling are territorially stored according to the local population, and the cities and counties are dispatched uniformly.

  6. Special class for quality control.

Mainly responsible for the quality control of nucleic acid testing in the region, set up a nucleic acid sampling supervision group and a nucleic acid testing supervision group to supervise the operation of sampling personnel, personal protection, laboratory testing quality control, and cross-infection prevention and control at sampling points and laboratories.

By strengthening quality control, false negatives or false positives are minimized, and false nucleic acid test reports are prevented.

  7. Special class for medical waste disposal.

It is mainly responsible for the collection, temporary storage, transfer, and disposal of medical waste generated in various stages of nucleic acid testing. According to the increase or decrease in the amount of medical waste, the frequency of removal and transportation is adjusted in time, and the medical waste is disposed of in a centralized manner.

  8. Special class for information security.

Responsible for the operation and monitoring of the nucleic acid detection information system, timely handle information system failures, ensure the safe operation of the system, and avoid problems such as downtime or system collapse; do a good job in ensuring communication during nucleic acid testing.

  9. Comprehensive management special class.

Mainly responsible for writing the regional nucleic acid detection work plan, nucleic acid detection analysis report, and the comprehensive coordination and guarantee work of each working class in the nucleic acid detection working group.

  All localities can add or merge the above 9 special classes according to the actual situation and according to the organization and mobilization, sample collection, sample testing, order maintenance, biosecurity, supervision and inspection, news publicity, etc. required for the work, but the responsibilities must be clear. , Implemented to people, there is no responsibility gap.

  3. Work content

  (1) Find out the population base.

All districts and cities implement the "Quartet Responsibility", establish a work ledger, and find out the actual management population of the streets (townships), communities, and communities within their jurisdiction through grid management and pull-net-type investigations.

  (2) Measure the sampling and testing ability.

Each district and city does not distinguish the population size, and they all match the sampling and testing forces according to the target 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 there are difficulties, it can be completed within 12 hours.

According to the standard that each sampling station (2 sampling personnel) collects 120 people per hour, the number of sampling personnel is calculated. The calculation formula is: number of nucleic acid sampling personnel (unit: person) = number of population ÷ 360; 10-in-1 mixed sampling detection technology is adopted , the detection ability calculation formula is: nucleic acid detection power (unit: tube/day) = population ÷ 10 × 2; if the 20-in-1 mixed detection technology is used, the detection capacity calculation formula is: nucleic acid detection power (unit: tube / Day) = population ÷ 20 × 2.

  (3) Refine the sampling plan.

  1. Sampling point setting.

First, scientific planning of sampling points.

Each city divided into districts shall scientifically plan the layout of sampling points based on the population size, geographic transportation, distribution of nucleic acid testing institutions, etc.

According to the daily sampling time of 6 hours, you can refer to 2000-3000 people to set up a sampling point, 600-800 people to set up a sampling station, and each sampling point needs 4-5 sampling stations (the local area can be based on the community, street, township , the actual population in rural and suburban areas), in principle, sampling points are set in the unit of community.

The second is scientific selection of sampling points.

The sampling point should be an open, well-ventilated, relatively independent site, and a gymnasium, exhibition hall, school playground and other venues with ventilation conditions and independent space can be selected.

Outdoor sampling sites are encouraged to be set up when natural conditions permit.

The third is to scientifically arrange sampling points.

The sampling point is divided into waiting area, sampling area, buffer area, temporary isolation area, and temporary storage area for medical waste, so as to effectively disperse the density of people to be tested.

Set up protective clothing putting on and take off areas, equipped with hand hygiene facilities, full-length mirrors or protective gear.

Sampling points need to set up clear guidance signs to ensure one-way flow of personnel, and clarify the sampling process and precautions.

Groups such as the elderly over 60 years old, pregnant women, and the disabled should set up a green channel for independent sampling.

Special nucleic acid detection sampling points (sampling channels) for personnel with health codes "yellow code" should be set up to avoid cross-infection caused by personnel.

Fourth, the rapid construction of sampling points.

It is required that the standard construction and use of the sampling points be completed within 2-4 hours. On the basis of fixed sampling points, a grid management mode is adopted, with sampling in the community as the main method, and refinement and improvement are carried out by entering schools, enterprises, and units. The layout is convenient for the masses to sample and improve the sampling efficiency.

  2. Sampling tissue.

On the basis of grid management, strengthen the organization and mobilization of nucleic acid sampling, clarify the departments and personnel responsible for the organization and mobilization work, and standardize the organization and mobilization work process.

Taking residential buildings, natural village groups, schools, government agencies, institutions, enterprises, companies, markets, hotels, etc. as the smallest unit, there is no shortage of households and no leakage of people.

The nucleic acid sampling site strengthens refined organizational management. While maintaining the work order by staff and volunteers, it is encouraged to strictly implement the "1-meter line" interval requirement by using physical means such as seats and metal grid lines.

By making reservations, notifications and sampling in advance in different time periods, people gather in a short time, and strive to avoid cross-infection.

  3. Sampling method.

Determine the sampling method according to the control measures that the target population has taken.

Centralized isolation points and other key populations are subject to single-collection and single-collection inspection; single-collection inspection or single-collection inspection for one household and one pipe is practiced in the control area; 10-in-1 mixed mining can be implemented in the control area; 20-in-1 mixed mining can be implemented in the prevention area and other areas .

If the apheresis and single inspection objects are not positive in multiple rounds of testing, 10-in-1 mixed sampling may be implemented as appropriate.

  (4) Implement sampling power.

Prepare sampling medical personnel and information entry personnel in advance, and carry out relevant training.

On the basis of a reasonable assessment of the workload, staffing, according to each sampling station should be equipped with 2 sampling personnel (must be medical personnel, consider changing shifts), 1 information entry personnel, and each sampling station should collect 120 samples per hour. .

Sampling medical staff should be proficient in the collection methods of nasopharyngeal and oropharyngeal swabs, and conduct strict personal protection and infection control training.

Information entry personnel should be proficient in the operation procedures of the nucleic acid detection information system and conduct relevant infection control training.

  (5) Sample preservation and transfer.

Test samples should be stored at low temperature (2-8°C).

One hour after the nucleic acid sampling in the start area, the first batch of samples should be transferred to the testing institution so that the testing institution can start operation.

Subsequent samples can be collected and transported every half an hour to 2 hours to ensure that they are delivered to the laboratory 3 hours after collection.

Priority will be given to the transfer of samples from sealed and controlled areas, and it is guaranteed that they will not be transferred more than once every 2 hours; remote villages, mountainous areas, and pastoral areas will reasonably determine the time and frequency of transfer according to specific conditions.

It can be referred to that the number of samples sent each time is about 10% of the single-day testing capacity of the testing institution, so that the testing can be carried out in an orderly manner.

  The sample transfer class will estimate the number of special vehicles, personnel and transfer boxes required for transfer according to the actual needs, and do a good job in the storage and transfer of vehicles, personnel and transfer boxes and other materials.

At the same time, it is necessary to report to the health and health administrative department for the record of the vehicles that undertake the regional nucleic acid testing and transfer tasks.

During the transshipment task, the vehicle shall not be used for other purposes, and the biosafety protection during transshipment shall be done well.

The transportation of non-inactivated samples must be approved by the health administrative department at or above the provincial level in accordance with the law.

Public security, transportation and other departments shall, according to actual needs, do a good job in transportation security.

  Do a good job in personnel protection and object disinfection during the transfer of nucleic acid samples.

Non-inactivated samples are packaged in accordance with the World Health Organization's "Guidelines for the Transport of Infectious Substances" in accordance with the UN2814 Class A infectious substances in PI602, and the inactivated samples are packaged in accordance with UN3373 Class B infectious substances in PI650.

Before the sample transfer box is closed, the surface of the container must be disinfected with 75% alcohol or 0.2% chlorine-containing disinfectant.

  (6) Strengthen the support of informatization.

  1. Establish a nucleic acid detection information system.

All provinces will coordinate the construction of regional nucleic acid testing information systems in districts and cities.

The information system should realize the rapid and accurate entry of relevant information, including the subject information (name, certificate type, certificate number, residential address, contact number) and sampling information (sampling point name, district/county, sample number, sample collection date, time, collection site, type, quantity), and quickly feedback the information of the subjects suspected of positive samples.

Realize fast, accurate and real-time monitoring of nucleic acid detection collection, delivery, inspection, and reporting information, and achieve full-process management of nucleic acid detection work.

The information system can support multi-role, multi-user, high-concurrency operation, and has the functions of collecting, sending and checking various kinds of information in real-time summary statistics.

Before going online, a stress test must be conducted in advance according to the standard of sampling 10% of the actual population under management every 10 minutes to ensure the stability of the information system.

  2. Do a good job in picking, sending, and matching.

Before starting the regional nucleic acid detection, the matching of collection, delivery and inspection should be done in advance, and dynamic scheduling should be carried out.

First, according to the sampling ability of the set sampling points and the actual detection ability of each testing institution, the matching of scribing and sample sending is done in advance.

Second, according to the experimental rhythm of nucleic acid testing institutions, samples are sent in batches and dynamically scheduled to achieve "no empty machines and no accumulation of samples", and make full use of the testing capabilities of various testing institutions.

  3. Nucleic acid result feedback.

All districts and cities should timely feedback nucleic acid test results, ensure accurate information in each link of collection, delivery, and inspection, provide the public with methods and methods for inquiring test results in a timely manner, and conduct pressure tests on the inquiry service system in advance to ensure that the masses take samples within 24 hours. results can be found.

  (7) Guarantee the supply of materials.

In accordance with the principle of "preparing rather than using, not being available but not prepared", before starting the regional nucleic acid detection work, material guarantee work must be done in advance.

Guaranteed sampling tubes (single tube, 10-in-1, 20-in-1, etc., inactivated sampling tubes are recommended), throat swabs (nasopharynx, oropharynx), detection reagents, medical consumables, protective equipment, disinfection Supplies and other materials are in sufficient supply, with good quality, suitable models and specifications, and office supplies, necessary daily necessities and other materials are in sufficient supply.

The material reserve of the sampling point should fully consider the factors of special weather such as rain and snow, low temperature, high heat, typhoon, etc., according to the layout of the sampling point, the inventory and ledger-type reserve management should be carried out.

  Fourth, scientifically determine the detection strategy

  The joint prevention and control mechanism of districts and cities should study and judge the spread of the epidemic according to the situation of traceability of the epidemic and the push of close contacts, and scientifically delineate risk areas and regional nucleic acid detection scopes and adjust them dynamically.

In principle, in the first 3 days after the outbreak of the epidemic, one round of regional nucleic acid testing will be carried out every day to find out the potential risks in the society; after that, the follow-up will be determined according to the comprehensive research and judgment of the traceability of the epidemic, the scope of community closure and control, and the results of nucleic acid screening. Screening scope and frequency.

  If the social risks are not under control and the risk points are unclear, continue to carry out one round of regional nucleic acid testing every day.

When the social risks are under control and the risk points are basically identified, key areas can be divided according to the distribution of cases for the relevant streets, communities and communities, and the key areas will be inspected once a day, and the non-key areas will be inspected every other day or 3 times depending on the situation. Inspections are carried out every day, and the inspection results are issued within the specified time as required.

Gradually reduce the scope of nucleic acid screening, improve screening accuracy, and conduct 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 new coronavirus antigen detection, increase antigen detection as a supplementary means of regional nucleic acid detection, and organize implementation after researching and refining the implementation plan.

  V. Standardize the positive sample disposal process

  (1) Procedures for the treatment of positive apheresis tests.

When the single-sample test result is positive, the testing institution should immediately report to the data statistics special class of the nucleic acid testing working group, and the data statistics special class will immediately notify the positive result disposal class, which will carry out the following five tasks: First, notify the 120 negative pressure ambulance. Carry out the transfer of the positive infected person; secondly, notify the centralized isolation management facility to prepare to receive the positive infected person; thirdly, notify the community (community) where the positive infected person is located to find and control the positive infected person; fourthly, notify the public security organs to assist in the transfer of the positive infected person , and carry out the investigation of the trajectory of the positive infected person; fifth, notify the disease control department to carry out follow-up investigation and traceability, close inspection and community closure and control.

The notices of the above departments are in no particular order.

  (2) The disposal process for positive mixed collection detection.

Each city has set up emergency sampling teams, which are on standby 24 hours a day and are ready to leave at any time.

When the mixed sampling test is positive, the testing agency should immediately report it to the nucleic acid testing working group, and the working group will also notify the emergency sampling team, the community (community) where the mixed sample is located, and the public security organ, and immediately isolate the people involved and conduct apheresis review.

Mixed positive apheresis review requires nasopharyngeal and oropharyngeal double apheresis.

The apheresis rechecked samples are subject to the first inspection responsibility system and sent to the original laboratory for testing.

The disposal of positive mixed detection should be completed within 6 hours (see the figure below for details).

  6. Strengthen the quality control of nucleic acid detection

  (1) Strengthen sampling quality control.

The nucleic acid sampling supervision team will guide each sampling point in a divided and contracted manner, standardize sampling operations, personal protection and cross-infection prevention and control and other related work, guide each sampling point to maintain order on site, strengthen the preservation and management of collected samples, and ensure that The sampling work is high quality and efficient.

  (2) Strengthen the testing quality control.

The nucleic acid testing supervision team has established a site supervision mechanism, and organized clinical inspection experts to conduct point-to-point supervision of each testing institution.

Laboratory performance verification, indoor quality control, and inter-laboratory quality assessment are carried out in accordance with the relevant requirements of the "Work Manual for Novel Coronavirus Nucleic Acid Detection in Medical Institutions (Trial Version 2)" to ensure the quality of testing.

Where the 20-in-1 mixed collection test is used for the first time, training and organization shall be strengthened in accordance with the "Technical Specifications for 20-in-1 Mixed Collection and Detection of New Coronavirus Nucleic Acids".

Strictly implement laboratory access and personnel access requirements, formulate standardized laboratory procedures, and strictly prevent laboratory contamination and cross-infection within the laboratory.

  7. Standardize personnel and other related management

  (1) Standardize personnel and laboratory biosafety management.

All localities should, in accordance with the "Biosafety Law", "Regulations on Biosafety Management of Pathogenic Microorganism Laboratories", "New Coronavirus Laboratory Biosafety Guidelines (Second Edition)" and other regulations, carry out laboratory filings as required, and strengthen laboratory biosafety management. Prevent biosecurity incidents from happening.

Strengthen infection control training for medical staff and other non-medical staff, and training on the application of regional nucleic acid detection information systems.

The protection requirements for sampling personnel and laboratory testing personnel shall be implemented in accordance with the Work Manual for Nucleic Acid Detection of Novel Coronavirus in Medical Institutions (Trial Version 2).

The local area should do a good job of overall planning and coordination, strengthen the care and care for the personnel involved in nucleic acid sampling and testing, and do a good job in logistical 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, ensure that the sealing is tight, and ensure that medical waste packaging is free from damage. Damaged, no leakage.

The special medical waste disposal class should coordinate in a timely manner with medical waste disposal units with corresponding qualifications to dispose of medical waste from transfer sampling points and nucleic acid testing institutions.

Medical waste generated at nucleic acid sampling sites must be cleared and transported on the same day; medical waste generated by nucleic acid testing institutions shall be cleared and transported on the same day when temporary storage conditions permit, and the temporary storage time shall not exceed 2 days.

Nucleic acid testing institutions should make an appointment with the receiving and shipping unit based on the temporary storage site and the storage situation of medical waste, and avoid strong winds and thunderstorms.

The receiving and transporting unit should optimize the scheduling of transport vehicles, reasonably arrange the receiving and transporting routes, and ensure the removal and transportation of medical waste.