I. Supervision and random inspection of infectious disease prevention and control

(1) The object of supervision and inspection.

Randomly check 15% of the second-level and above hospitals, 5% of the first-level hospitals, 2% of primary medical institutions (community health service centers/stations, clinics, township health centers, village clinics, etc.), 20% of disease prevention and control institutions and blood collection and supply institutions. .

(2) Contents of supervision and inspection.

1. Vaccination management. Qualification of the inoculation unit; publicity of vaccination; inform and inquire about the situation of the inoculated person or guardian before vaccination; implementation of "three checks and seven pairs" and "one verification"; vaccine reception, purchase, storage, distribution, supply, Vaccination and disposal records.

2. Report on the epidemic situation of infectious diseases. Establishment of the reporting system for infectious diseases; self-inspection of the management of infectious diseases; the registration of infectious diseases and the filling of report cards; whether there is concealment, delay or false reporting of infectious diseases.

3. Epidemic control of infectious diseases. Establishment of pre-examination and triage system; providing diagnosis and treatment for infectious disease patients and suspected patients according to regulations; disinfection and disposal of places, articles, sewage and medical waste contaminated by infectious disease pathogens; performance of infectious disease monitoring duties according to law; detection of infectious diseases In the event of an epidemic, measures to control infectious diseases are taken.

4. The implementation of disinfection and isolation measures. The establishment of disinfection management organization and system; the monitoring of disinfection and sterilization effects; the training of disinfection and isolation knowledge; the inspection and acceptance of disinfection products; Hospitals above the second level focus on stomatology (diagnosis and treatment centers), hemodialysis and disinfection supply centers. If there are no related departments, key departments can be selected according to the situation. First-level hospitals and primary medical institutions focus on the inspection of hospital stomatology or dental clinics, beauty hospitals, and hemodialysis centers.

5. Disposal of medical waste. The status of classified collection of medical waste; the use of special packaging and containers; the establishment of temporary storage facilities for medical waste; the handover, transportation, temporary storage and disposal of medical waste.

6. Biosafety management of secondary pathogenic microorganism laboratory. The filing status of the secondary laboratory; the training and assessment of personnel engaged in experimental activities; the establishment of experimental files; the destruction of bacteria (virus) strains or samples or sending them to the preservation institution for preservation at the end of the experiment.

II. Supervision and random inspection of disinfection products

(1) The object of supervision and inspection.

Random inspection of 30% of the first-class disinfection product manufacturers in the jurisdiction; 30% of the second-class disinfection product manufacturers except antibacterial (antibacterial) preparations; 100% of antibacterial (antibacterial) preparation manufacturers; 25% of the third category Disinfection product manufacturer. The production enterprises that produce the first and second types of disinfection products at the same time are selected according to the production enterprises that produce the first type of disinfection products.

(2) Contents of supervision and inspection.

1. The content of supervision and inspection of the first category of disinfection product manufacturers includes production conditions, production process, hygiene quality of raw materials, and disinfection product hygiene and safety evaluation reports, labels (nameplates), instructions, etc. Among them, manufacturers of high-level disinfectants and sterilants for medical devices focus on the hygienic quality of raw materials, production water, factory inspection reports and production records; manufacturers of skin and mucous membrane disinfectants focus on inspections of purification workshops, raw material hygienic quality, production water, and factory inspection reports. , banned substances and production records, etc.; biological indicators, chemical indicators of sterilization effect, high-level disinfection equipment for medical devices, and sterilization equipment manufacturers focus on inspection of production facilities, factory inspection reports and production records, etc.

2. The content of supervision and inspection of the second category of disinfection product manufacturers includes production conditions, production process, hygienic quality of raw materials, and sanitation and safety of disinfection products.

Evaluation reports, labels (nameplates) and instructions, etc. Among them, hand sanitizer manufacturers focus on inspection of factory inspection reports and production records; other disinfectant and disinfection equipment (including indicators) manufacturers focus on inspection of production equipment, raw material hygiene quality, factory inspection reports and production records.

Manufacturers of antibacterial (antibacterial) preparations should focus on checking whether the sanitary license is within the validity period, whether the production items, categories, and conditions are consistent with the sanitary license, and check whether the production process records, raw material incoming and outgoing records, product batch inspection records, etc. meet the requirements requirements; check whether the content of the antibacterial (antibacterial) preparations health and safety evaluation report is complete and qualified and put on record; check whether the antibacterial (antibacterial) preparations product name, label, instruction manual, packaging, etc. are standardized, whether there are violations of laws and regulations to promote efficacy and label prohibited substances, etc. Happening.

3. The content of supervision and inspection of the third category of disinfection product manufacturers includes production conditions, production process, and disinfection product labels and instructions. Among them, diapers and other excrement hygiene products, women's menstrual hygiene products manufacturers focus on the inspection of raw material hygiene quality, air disinfection facilities, and factory inspection reports.

4. Spot check products and test items are detailed in Attachment 3.

The first category of disinfection products: no less than 15 products are selected from each province for inspection, and the focus is on chlorine-containing disinfectants (if the total number of products is less than 15, all the products of the selected manufacturers will be inspected);

The second category of disinfection products: no less than 30 antibacterial (antibacterial) ointments and creams are selected from each province, which can be checked with reference to the "Technical Specification for Safety of Cosmetics" (2015 edition) to check whether the banned substance clobetasol propane is illegally added. Acid esters, etc., mainly products produced by enterprises in this province, focusing on sampling in pharmaceutical companies, retail pharmacies, mother and baby stores, shopping malls and supermarkets, infant bathing and swimming places, hospitals and other operating and user units. At the same time, check whether the product name, label, instruction manual, packaging, etc. are standardized, and whether there is any violation of laws and regulations to promote efficacy. Except for antibacterial (antibacterial) products, no less than 25 products are selected for inspection, and the focus is on low-temperature disinfectants. ;

The third category of disinfection products: no less than 10 products are selected from each province for inspection, focusing on random inspection of adult excrement hygiene products and women's menstrual hygiene products (if the total number of products is less than 10, all the products of the selected manufacturing enterprises will be inspected ). If the "double random" object is randomly checked and found that the number of disinfection products in its category is insufficient, it will be supplemented by the number of disinfection products in other categories of the enterprise.

III. Job requirements

(1) All localities should attach great importance to the national supervision and random inspection of infectious disease prevention and disinfection products, and formulate and organize the implementation of work implementation plans in their respective jurisdictions in light of the normalized epidemic situation. The work of supervision and random inspection of infectious disease prevention and control shall be combined with the work of classified supervision and comprehensive evaluation of medical and health institutions, and the selected units shall be inspected by means of classification and comprehensive evaluation. At the same time, focus on strengthening the supervision and inspection of medical testing laboratories engaged in nucleic acid testing, and find violations of laws and regulations, and severely punish them in accordance with the law. The supervision and random inspection of disinfection products should adhere to the problem orientation, and check one by one the hygienic licensing specifications of antibacterial (antibacterial) preparation enterprises, the compliance of the hygienic safety evaluation report of the antibacterial (antibacterial) preparations that have been filed, and whether antibacterial (antibacterial) creams and creams are Illegal addition of prohibited substances such as hormones, this content will be included in the 2022 national evaluation of combating intellectual property infringement and manufacturing and selling fake and shoddy goods.

(2) Intensify testing and strictly investigate and punish illegal acts. When suspicious disinfection products are found during the random inspection process, samples should be taken for inspection in a timely manner, and sampling and inspection efforts should be intensified to prevent unqualified products from entering the market; if the addition of prohibited substances is found, the enterprise should be ordered to immediately stop production and sales. The Special Provisions on Strengthening the Safety Supervision and Administration of Food and Other Products" shall be strictly investigated and dealt with according to the law; if any problematic products outside the jurisdiction are found, the health administrative department of the place where the production enterprise is located shall be notified in a timely manner, and inter-provincial and inter-city joint investigation and punishment shall be intensified. strength, and those suspected of committing crimes should be handed over to the public security organs in a timely manner.

(3) Before November 15, 2022, all localities should complete the thorough inspection of antibacterial (antibacterial) preparation enterprises and the random inspection of antibacterial (antibacterial) preparation ointments and creams, and inspect the antibacterial (antibacterial) preparation manufacturers in their own provinces. The summary of the random inspection of antibacterial (antibacterial) preparations and creams (electronic version), the summary table of inspection cases (Appendix 6 and 7), and the list of products with illegally added banned substances (Appendix 8) were submitted to our commission. Major cases and important situations to report at any time.

Other random inspection tasks and data reporting work should be completed before November 30, 2022. The summary table marked with "★" in the header of the national supervision and random inspection of disinfection products cannot be directly generated through the "information reporting system" case report, and a summary table needs to be filled in. report information. At the same time, each provincial health administrative department will submit the electronic version of the summary of the supervision and inspection of infectious disease prevention and disinfection products in their province to our commission.

⭐ The attached table can be obtained by scanning the QR code