Chapter I General Principles
Article 1 In order to protect public health and standardize the health supervision of infectious disease prevention and control, this Code is formulated in accordance with the Law of People's Republic of China (PRC) on the Prevention and Control of Infectious Diseases and relevant laws and regulations.
Article 2 The sanitary supervision on the prevention and treatment of infectious diseases as mentioned in this Code refers to the activities of local health and family planning administrative departments at or above the county level and their comprehensive supervision and law enforcement agencies to supervise and enforce the prevention and treatment of infectious diseases in medical and health institutions in accordance with relevant laws and regulations on the prevention and treatment of infectious diseases.
The medical and health institutions mentioned in this specification include medical institutions, disease prevention and control institutions and blood collection and supply institutions.
Article 3 The local health and family planning administrative departments at or above the county level shall be responsible for the capacity building of health supervision for the prevention and treatment of infectious diseases, ensuring the staffing, rationally allocating the working equipment, and bringing the working funds into the budget management.
Fourth local health and family planning administrative departments at or above the county level and their comprehensive supervision and law enforcement agencies shall apply this specification when carrying out health supervision on the prevention and control of infectious diseases.
Chapter II Supervision Duties and Requirements
Fifth provincial health and family planning administrative departments and their comprehensive supervision and law enforcement agencies:
(a) to formulate the province's (autonomous regions and municipalities) health supervision work plan, annual plan, and the corresponding work system; According to the health supervision of infectious disease prevention and control, determine the annual key supervision work;
(two) the organization and implementation of the province (autonomous regions and municipalities) infectious disease prevention and health supervision and related training; Guide and supervise the health supervision of infectious disease prevention and control at lower levels;
(3) Organizing, coordinating, supervising and investigating major illegal cases in the prevention and control of infectious diseases within its jurisdiction;
(four) to undertake the task of national health supervision and sampling inspection, and organize the implementation of health supervision and sampling inspection within its jurisdiction;
(five) responsible for the province (autonomous regions and municipalities) infectious disease prevention and health supervision information management and data collection, verification, analysis and reporting;
(six) to undertake the task of health supervision for the prevention and control of infectious diseases designated or assigned by the superior.
Sixth districts of the city and county health and family planning administrative departments and their comprehensive supervision and law enforcement agencies:
(a) according to the province (autonomous regions and municipalities) infectious disease prevention and health supervision work plan, annual plan, combined with the actual situation, formulate the infectious disease prevention and health supervision plan within the jurisdiction, clear the key supervision content and organize the implementation;
(2) Organizing health supervision and training on the prevention and treatment of infectious diseases within its jurisdiction;
(3) Organizing the daily health supervision work for the prevention and control of infectious diseases, such as vaccination in medical and health institutions, report on epidemic situation of infectious diseases, measures for controlling epidemic situation of infectious diseases, implementation of disinfection and isolation system, disposal of medical wastes, and biosafety management of pathogenic microorganism laboratories;
(four) to investigate and deal with illegal cases of infectious disease prevention and control within its jurisdiction;
(five) responsible for the collection, verification, analysis and reporting of health supervision information on the prevention and control of infectious diseases within its jurisdiction;
(six) the city divided into districts shall guide and supervise the health supervision of the prevention and control of infectious diseases at the county level;
(seven) to undertake the task of health supervision for the prevention and control of infectious diseases designated or assigned by the superior.
Seventh provincial and municipal comprehensive supervision and law enforcement agencies shall designate specific departments (offices) to be responsible for the health supervision of infectious disease prevention and control; County-level comprehensive supervision and law enforcement agencies should have departments responsible for the prevention and supervision of infectious diseases or designate special personnel to engage in the health supervision of infectious diseases prevention and control.
Eighth before the implementation of on-site health supervision, the supervisor should be clear about the tasks, methods and requirements of health supervision for the prevention and treatment of infectious diseases, check the safety protection equipment, and do a good job in safety protection.
Ninth on-site health supervision found illegal behavior, should collect evidence according to law; In the case that evidence may be lost or difficult to obtain later, evidence preservation measures should be taken in advance according to law.
Tenth local comprehensive supervision and law enforcement agencies at or above the county level shall establish health supervision files for the prevention and control of infectious diseases, and grasp the basic situation of medical and health institutions and the prevention and control of infectious diseases within their respective jurisdictions.
Chapter III Contents and Methods of Health Supervision
Section 1 Health Supervision of Vaccination
Eleventh health supervision of disease prevention and control institutions and vaccination units:
(a) the qualifications of vaccination units and personnel;
(two) publicity and notification (query) of the inoculation entity;
(3) Registration and report on the receipt, purchase, distribution, supply and use of vaccines;
(four) the handling and reporting of abnormal reactions or suspected abnormal reactions to vaccination;
(five) disease prevention and control institutions to carry out vaccination related publicity, training, technical guidance and other work.
Twelfth of the disease prevention and control institutions, vaccination units of supervision and inspection, mainly take the following ways:
(a) access to the vaccination unit's "Practice License for Medical Institutions", the certification documents designated by the county-level health and family planning administrative departments, and the vaccination professional training and assessment materials for staff;
(two) to check the records of the first type of vaccine or the purchase of the second type of vaccine, the records of the vaccination registration report, and the records of the remaining first type of vaccine after the completion of the national immunization plan;
(three) to consult the records of the medical and health personnel of the inoculation unit who informed and inquired about the recipients or their guardians before inoculation; Consult the vaccination records filled out by the medical and health personnel who carry out vaccination;
(four) to check the varieties and inoculation methods of the first kind of vaccine publicized by the inoculation unit in a prominent position in the inoculation site;
(five) access to the township medical and health institutions to undertake the vaccination work of the village medical and health institutions to issue the first kind of vaccine records;
(six) access to the disease prevention and control institutions of vaccine procurement, distribution and supply records, check the record retention period;
(seven) access to the records and materials of the disease prevention and control institutions to carry out vaccination related publicity, training, technical guidance and other work;
(eight) access to disease prevention and control institutions, vaccination units from vaccine production enterprises, vaccine wholesale enterprises to receive or buy vaccines, to see the preservation period of the documents;
(nine) access to disease prevention and control institutions and vaccination units to deal with abnormal reactions or suspected abnormal reactions to vaccination and report records.
Section 2 Health Supervision of Infectious Disease Epidemic Report
Thirteenth health supervision contents of infectious disease epidemic report:
(a) the establishment of infectious disease epidemic report management organization and system;
(two) to perform the epidemic situation report, daily management and quality control of infectious diseases according to law;
(three) the disease prevention and control institutions timely review and confirm the epidemic information of infectious diseases within their respective jurisdictions, and carry out epidemic analysis, investigation and verification;
(four) the disease prevention and control institutions shall perform their duties to inform the relevant departments of the epidemic situation of infectious diseases.
Fourteenth disease prevention and control institutions of infectious disease epidemic situation report supervision and inspection, mainly adopt the following methods:
(a) access to the establishment of epidemic report management departments or clear division of responsibilities for epidemic report management documents and materials, access to epidemic report management departments and full-time epidemic report personnel, access to infectious disease epidemic report management system;
(two) access to infectious disease epidemic reports and audit records, all kinds of conventional epidemic analysis reports and other written materials, check the establishment of epidemic duty and consultation telephone; After receiving the infectious disease report card submitted by the responsible reporting unit that does not have the conditions for direct network reporting, check the situation of direct network reporting;
(3) consulting the notification system of infectious diseases, and notifying each other of epidemic records of Class A infectious diseases with ports, airports, railway disease prevention and control institutions and frontier health and quarantine organs; Inform each other with the animal epidemic prevention agencies about the epidemic situation of infectious diseases between animals and people and record relevant information; (four) to check the operation of the infectious disease network direct reporting equipment, and the epidemic reporting personnel to demonstrate the reporting, verification and duplicate checking of infectious diseases on the spot;
(five) access to other records related to the epidemic report of infectious diseases.
Fifteenth supervision and inspection of the epidemic situation report of infectious diseases in medical institutions, mainly take the following ways:
(a) to establish an epidemic report management department or clarify the division of responsibilities for epidemic report management, and to inspect full-time epidemic report personnel; Consulting the management system of infectious disease report should include the diagnosis, registration, reporting, rapid feedback of abnormal information and self-examination of infectious diseases.
(II) access to the original diagnosis and treatment registration (including outpatient log, admission registration, examination and image positive results), infectious disease report card, infectious disease network direct reporting information and other materials, and check the situation of failing to report the epidemic situation of infectious diseases in accordance with the provisions or concealing, falsely reporting or delaying the epidemic situation of infectious diseases;
(three) access to the records and related materials of internal self-examination in the management of infectious disease epidemic report;
(four) to consult the information on organizing clinicians and new employees to carry out professional training and assessment of infectious disease report management on a regular basis;
(five) to check the special equipment and operation of direct network reporting of infectious diseases, and full-time epidemic reporting personnel to demonstrate the operation of direct network reporting of infectious diseases;
(six) for medical institutions below the county level that do not have the conditions for direct reporting on the Internet, consult the registration records of infectious disease reports.
Article 16 The following methods shall be mainly adopted for the supervision and inspection of the epidemic situation of infectious diseases in blood collection and supply institutions:
(a) access to infectious disease epidemic report management system;
(two) to check the registration of two HIV antibody positive results, as well as the list of blood donors or plasma donors, and to check the report of HIV positive results and check the confirmation;
(three) for the establishment of the network direct reporting system of epidemic situation, check the demonstration of the network direct reporting operation of epidemic situation reporting personnel, and check the operation of the network direct reporting system of infectious diseases;
(four) for institutions that do not have the conditions for direct online reporting, consult the registration records of infectious disease reports.
Section 3 Health Supervision on Epidemic Control of Infectious Diseases
Seventeenth health supervision contents of infectious disease epidemic control in medical institutions:
(a) the establishment and implementation of the system of pre-inspection and triage of infectious diseases; Check the implementation of protective measures for medical and health personnel and patients;
(two) the establishment and operation of infectious diseases department or triage point;
(three) when the epidemic situation of infectious diseases is discovered, the situation of providing diagnosis and treatment for patients with infectious diseases and suspected infectious diseases in accordance with the regulations;
(4) Implementing disinfection and isolation measures; Disinfect sewage, dirt, places and articles contaminated by infectious disease pathogens.
Eighteenth supervision and inspection of medical institutions to control the epidemic situation of infectious diseases, mainly take the following ways:
(a) access to infectious disease pre-inspection, triage system and emergency plan management documents;
(two) to check the setting of infectious diseases department or triage point and the implementation of pre-inspection triage;
(three) to check the implementation of protective measures for medical and health personnel and patients;
(four) check the situation of providing diagnosis and treatment services for patients with infectious diseases and suspected infectious diseases;
(five) to check the places, facilities and equipment and use records of the isolation control measures for patients with legal infectious diseases or suspected infectious diseases. Consult the disinfection or harmless disposal records of places and articles contaminated by infectious disease pathogens and medical wastes.
Nineteenth disease prevention and control institutions of infectious disease epidemic control of health supervision content:
(a) to perform the duties of monitoring infectious diseases according to law;
(two) when the epidemic situation of infectious diseases is discovered, the situation of taking timely measures to control infectious diseases in accordance with the principle of territorial management.
Twentieth disease prevention and control institutions to control the epidemic situation of infectious diseases, mainly in the following ways:
(1) To consult the infectious disease monitoring system, the infectious disease monitoring plan and work plan within its jurisdiction, collect, analyze and report the infectious disease monitoring information, and predict the occurrence and epidemic trend of infectious diseases;
(two) to consult the technical plan or plan for the investigation and handling of infectious diseases, as well as the records and reports of the investigation and handling of infectious diseases;
(three) access to epidemiological investigation records and data of infectious diseases, as well as health treatment records of epidemic spots and epidemic areas.
Section 4 Hygienic Supervision over the Implementation of Disinfection and Isolation System
Twenty-first the implementation of disinfection and isolation system of health supervision content:
(a) the establishment and implementation of disinfection management organization and system;
(two) medical and health personnel receive disinfection technical training, master disinfection knowledge, and implement disinfection and isolation system;
(3) Disinfection and sterilization of medical supplies and instruments;
(four) to carry out disinfection and sterilization effect testing;
(5) Inspection, acceptance, use and management of incoming goods in disinfection products;
(six) the implementation of disinfection and isolation measures for patients with infectious diseases and suspected infectious diseases.
Twenty-second supervision and inspection of the implementation of the disinfection and isolation system, mainly take the following methods:
(a) access to disinfection management organization documents, disinfection management system, work plan and inspection records;
(two) access to staff disinfection technology training records; Ask the relevant staff about disinfection and isolation knowledge on site; Check the implementation of disinfection and isolation system for relevant staff;
(three) access to disinfection and sterilization effect test records or test reports, access to the test results are not qualified rectification records. If necessary, conduct on-site sampling to monitor the disinfection and sterilization effect;
(four) access to disinfection products incoming inspection and acceptance records; Check the relevant supporting documents, use date and validity period of disinfection products;
(five) check the relevant departments of medical institutions (focusing on fever clinic, intestinal clinic and infectious diseases department, etc.). Implement disinfection technical specifications, standards and regulations;
(six) check the places, facilities and measures to isolate patients with infectious diseases and suspected patients with infectious diseases.
Section 5 Health Supervision of Medical Waste Disposal
Twenty-third health supervision contents of medical waste disposal:
(a) the establishment and implementation of medical waste management organization, system and emergency plan;
(2) Occupational health and safety protection and training for staff and managers engaged in classified collection, transportation, temporary storage and disposal of medical wastes;
(3) Classified collection, transfer and registration of medical wastes;
(4) Temporary storage of medical wastes;
(5) Treatment of medical wastes and sewage;
(six) the implementation of centralized medical waste disposal of medical and health institutions and qualified medical waste centralized disposal units signed a contract; Medical and health institutions that do not have the conditions for centralized disposal of medical wastes dispose of medical wastes by themselves according to the requirements of relevant departments.
Twenty-fourth supervision and inspection of medical waste disposal, mainly take the following ways:
(1) Consult the documents of the medical waste management monitoring department or full-time (part-time) personnel setting and post responsibilities, and check the monitoring department and management personnel;
(two) access to medical waste management responsibility system, medical waste classification collection, transfer, registration and other rules and regulations and emergency plans;
(three) to obtain the training materials for the staff and managers of classified collection, transportation, temporary storage and disposal of medical wastes, relevant laws and professional technology, safety protection and emergency treatment;
(four) to check the occupational health and safety protection equipment of the staff and managers engaged in the classified collection, transportation, temporary storage and disposal of medical wastes, and to consult the health inspection records;
(5) Consult the medical waste register, check whether the classified collection points of medical wastes use special packages or containers to collect medical wastes according to the Catalogue of Medical Waste Classification, and check the description and warning signs of the classified collection methods of medical wastes;
(six) inspection of medical waste transport, special packaging or containers, temporary storage places and conditions, inspection of medical waste transportation routes;
(seven) to check the disinfection and cleaning places and conditions of the used medical waste transport tools;
(eight) to obtain information such as the qualification of the centralized medical waste disposal unit and the transfer list of hazardous waste; Check the facilities, methods and records of medical waste disposal in medical and health institutions that do not have the conditions for centralized disposal of medical waste;
(nine) to check the disinfection equipment and facilities for sewage and excreta of patients with infectious diseases or suspected patients with infectious diseases, and their operation and maintenance; Check disinfection records and monitoring records.
Section 6 Hygienic Supervision of Biosafety Management in Pathogenic Microorganism Laboratory
Twenty-fifth pathogenic microorganism laboratory biosafety management of health supervision content:
(1) Records of the first and second pathogenic microorganism laboratories; Qualification of the third-and fourth-grade pathogenic microorganism laboratory to carry out experimental activities of highly pathogenic microorganisms;
(2) Training, assessment and certification of personnel engaged in experimental activities;
(three) the formulation and implementation of management system and emergency plan;
(four) to carry out experimental activities;
(five) the establishment and preservation of experimental files;
(6) Collection, transportation and preservation of bacteria (viruses) and samples.
Twenty-sixth supervision and inspection of pathogenic microorganism laboratory bacteria (virus) species and samples collection, transportation and experimental activities management, mainly take the following ways:
(a) to obtain the first-class and second-class laboratory registration certificates and the third-class and fourth-class laboratories "Highly Pathogenic Microbiology Laboratory Qualification Certificate";
(two) access to laboratory staff training, assessment materials and certificates;
(three) to consult the records of destroying pathogenic microorganism strains and samples in the laboratory or sending them to the preservation institution for safekeeping;
(four) check the corresponding equipment configuration of level 2 and above laboratories;
(five) access to experimental files; Check the retention period of experimental files related to the experimental activities of highly pathogenic microorganisms;
(six) to consult the approval documents for engaging in some highly pathogenic microorganisms or suspected highly pathogenic microorganisms; Consult the documents that prove that the laboratory can engage in experimental activities related to highly pathogenic microorganisms by using new technologies and methods; Consult the qualification documents and records of related experimental activities of pathogenic microorganisms that have not been discovered or announced for elimination in China;
(seven) the safety access system for highly pathogenic microorganism laboratories; Check the biohazard signs and biosafety laboratory level signs marked in obvious positions in the third and fourth laboratories, as well as the equipment of protective equipment for personnel entering the laboratories;
(eight) to consult the records of registered experimental activities and results reports related to highly pathogenic microorganisms or suspected highly pathogenic microorganisms; Check whether there are two or more highly pathogenic microorganisms engaged in related experimental activities in the same laboratory and the same independent safety area at the same time;
(nine) to consult the emergency plan for laboratory infection of highly pathogenic microorganisms and the information filed with the local provincial health and family planning administrative department;
(ten) access to the laboratory staff infected with highly pathogenic microorganisms and laboratory reports and disposal records of highly pathogenic microorganisms leakage;
(eleven) to consult the records of the sources, collection processes and methods of highly pathogenic microorganisms;
(twelve) to obtain the approval documents for transporting highly pathogenic microorganisms (viruses) or samples; Check the reports and records of stolen, robbed, lost and leaked strains and samples of highly pathogenic microorganisms during transportation.
Twenty-seventh supervision and inspection institutions to manage the storage of bacteria (viruses) and samples, mainly in the following ways:
(a) to consult the qualification certificate of the depository institution;
(2) To consult the safe storage system, the records of the entry and exit of pathogenic microorganism strains (virus strains) and samples, accept the registration of pathogenic microorganism strains (virus strains) and samples submitted by the laboratory, and issue an acceptance certificate;
(three) to check the registration of strains and samples of highly pathogenic microorganisms provided to the laboratory, and to check the approval documents submitted by the laboratory for engaging in experimental activities related to highly pathogenic microorganisms; Check whether strains and samples of highly pathogenic microorganisms (viruses) are stored separately in special warehouses or counters;
(4) The obtained strains (virus strains) and samples of highly pathogenic microorganisms are stolen, robbed, lost or leaked during storage.
Chapter IV Information Management
Twenty-eighth health and family planning administrative departments at all levels should strengthen the construction of health supervision information system for the prevention and control of infectious diseases, organize and analyze the health supervision information for the prevention and control of infectious diseases in this area, and provide a basis for formulating relevant policies for the prevention and control of infectious diseases.
Twenty-ninth comprehensive supervision and law enforcement agencies at all levels shall regularly summarize and analyze the health supervision information on the prevention and control of infectious diseases, and report to the health and family planning administrative departments at the same level and the comprehensive supervision and law enforcement agencies at higher levels.
Comprehensive supervision and law enforcement agencies at all levels shall set up full-time (part-time) staff to be responsible for the collection and reporting of health supervision information on the prevention and control of infectious diseases in this area, and timely and accurately report relevant information on supervision and inspection.
Chapter V Handling of Supervision Situation
Article 30 After the local health and family planning administrative departments at or above the county level and their comprehensive supervision and law enforcement agencies carry out health supervision on the prevention and treatment of infectious diseases, they shall promptly feed back the inspection results to the inspected units, and link the supervision and inspection results with the management work such as scoring, verification and rating of bad practice behaviors of medical institutions. There are problems, issued by the health supervision opinions; There are illegal acts, should be investigated and dealt with according to law; Anyone suspected of committing a crime shall be promptly transferred to the local public security organ.
Article 31 If the bacteria (virus) species preservation institution fails to preserve the bacteria (virus) species and samples submitted by the laboratory in accordance with the regulations, or fails to provide the bacteria (virus) species and samples in accordance with the regulations, the local health and family planning administrative department at or above the county level shall report it step by step in time.
Thirty-second major cases of illegal prevention and control of infectious diseases, the local health and family planning administrative departments at or above the county level shall promptly report to the health and family planning administrative departments at higher levels.
Chapter VI Supplementary Provisions
Article 33 Relevant laws, regulations and rules shall apply to the prevention of infectious diseases and health supervision in disinfection products, drinking water, schools and public places.
Health supervision of infectious disease prevention and control in medical waste centralized disposal units, scientific research institutions and other relevant units shall be implemented with reference to this specification.
Thirty-fourth during the outbreak and epidemic of infectious diseases, the local health and family planning administrative departments at or above the county level and their comprehensive supervision and law enforcement agencies should focus on the supervision and inspection of the epidemic report and epidemic control measures of infectious diseases in medical and health institutions.
Article 35 These Standards shall come into force as of the date of promulgation. The Standard for Daily Health Supervision of Infectious Diseases Prevention and Control (No.82 [20 10] issued by the former Ministry of Health in September) shall be abolished at the same time.