Methods for the Management of National AIDS Testing Article 1 In order to strengthen the supervision and management of national AIDS testing, standardize the setup and acceptance of AIDS testing laboratories, and ensure the quality of AIDS testing, these management methods are formulated in accordance with the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases, the Regulations on the Prevention and Control of AIDS, and the provisions of relevant national laws and regulations.
Second, the Ministry of Health is in charge of the national AIDS testing and its supervision and management, and the local health administrative departments at or above the county level are in charge of the AIDS testing and its supervision and management within their jurisdiction.
Article 3 The Chinese Center for Disease Control and Prevention and the Centers for Disease Control and Prevention of the provinces, autonomous regions and municipalities bear the day-to-day management of AIDS testing. Disease prevention and control institutions at all levels, medical institutions, blood collection and supply institutions, family planning technical service institutions, etc. to undertake their responsibilities within the scope of AIDS testing, and accept the Chinese Center for Disease Control and Prevention and the provinces, autonomous regions and municipalities directly under the Central Center for Disease Control and Prevention of the operational guidance.
Article 4 These administrative measures shall apply to all organizations that carry out AIDS testing work nationwide. Article 21 The AIDS testing laboratories shall, in accordance with relevant state laws and regulations, disinfection and harmless disposal of contaminated places, objects and medical waste, and follow the "standard protection principle" to prevent internal and external contamination of the laboratory.
Article 22 of the AIDS testing work involves the collection, storage, carrying and transportation of HIV strains and test samples, must comply with the relevant provisions of the Ministry of Health.
Article 23 of the AIDS testing laboratories must implement the "General Requirements for Laboratory Biosafety" (GB 19489-2004) requirements and the relevant provisions of the Ministry of Health.
Article 24 After the occurrence of occupational exposure of AIDS testing laboratory personnel, should be in accordance with the "Guidelines for the Protection of Medical Personnel against Occupational Exposure to HIV (for trial implementation)" and other relevant provisions of timely treatment. Article 25 The AIDS Reference Laboratory is responsible for checking the testing quality of the national AIDS testing laboratories. The Laboratory of AIDS Confirmation Center is responsible for checking the testing quality of AIDS testing laboratories within its scope of responsibility.
Article 26 The AIDS testing laboratories shall establish and improve the laboratory quality assurance and quality control system, and have a person responsible for the normal operation of the quality system.
Article 27 AIDS testing and screening laboratories must participate in laboratory capacity testing at or above the provincial level; AIDS testing laboratories must participate in the Chinese Center for Disease Control and Prevention of laboratory capacity testing organization. AIDS testing laboratory proficiency testing results by the organizers of regular public release. Article 28 The health administrative departments at all levels shall strengthen the supervision and management of AIDS testing laboratories. Laboratory without acceptance or unqualified acceptance to carry out AIDS testing work without authorization, by the health administrative departments at this level or higher ordered to make corrections within a certain period of time, and notification of criticism.
Article 29 HIV testing laboratories in one of the following cases, the local or higher-level health administrative department shall order corrections within a specified period of time, and according to the law of their institutions, units and responsible persons to investigate and deal with:
(a) HIV testing and screening laboratories issued a positive report of HIV antibodies and screening positive samples are not sent to the test in accordance with the regulations;
( (ii) the use of reagents that do not comply with the provisions of these measures;
(iii) in the work of AIDS testing did not carry out laboratory indoor quality control or did not participate in laboratory proficiency testing;
(iv) the use of non-health technicians or untrained and qualified technicians to engage in the work of AIDS testing;
(v) not in accordance with the provisions of the laboratory wastes, dirt, and
(vi) falsification in the work of AIDS testing, issuing false test reports;
(vii) unauthorized modification of testing records or failure to keep records in accordance with the provisions, resulting in serious consequences;
(viii) violation of other relevant provisions of this management approach. Article 5 The administrative departments of health at or above the provincial level shall, according to the layout of medical and health institutions and the prevalence of AIDS, coordinate the planning and determination of laboratories undertaking AIDS testing.
Article VI of the State of AIDS testing laboratories to implement categorization and management, according to the functions of the laboratory, the nature and scope of testing work **** divided into three categories of laboratories, respectively, AIDS reference laboratory, AIDS testing confirmation laboratory, AIDS testing and screening laboratories.
(I) AIDS reference laboratories.
The AIDS reference laboratory is located in the Chinese Center for Disease Control and Prevention. Its functions include:
1, undertake the national AIDS testing laboratory network construction of business and technical guidance and evaluation.
2. It establishes a national quality assurance and quality control system for AIDS testing, and organizes national laboratory capacity verification and clinical quality assessment of AIDS diagnostic reagents.
3, undertake the analysis and confirmation of difficult samples for AIDS testing, arbitrate disputed test results and issue final test reports.
4, to carry out applied research, and undertake related testing tasks in the identification of pathogenicity, on-site comprehensive prevention and treatment, research, monitoring, clinical treatment and other work related to AIDS prevention and treatment.
5. To establish the national HIV viral stock, sample stock, quality control product stock, gene stock and cell stock.
6. Provide technical support and guidance for the laboratories of the AIDS Confirmation Center to carry out quality management of provincial laboratories, clinical quality assessment of AIDS diagnostic reagents at provincial level, and voluntary counseling and testing.
7. It organizes national business training related to AIDS testing, and organizes the formulation and revision of technical specifications and guidelines related to AIDS testing work.
(2) AIDS testing and confirmatory laboratories.
Including AIDS confirmation center laboratory and AIDS confirmation laboratory. AIDS corroboration center laboratory located in the provincial disease prevention and control center. AIDS confirmatory laboratory can be located in disease prevention and control institutions, medical institutions, blood centers, family planning technical service institutions.
1, AIDS confirmatory laboratory functions
(1) is responsible for the scope of responsibility of the AIDS testing laboratory network construction of business and technical guidance and evaluation, the organization of AIDS testing laboratory personnel technical training.
(2) To establish a quality control system for AIDS testing laboratories, and to organize provincial laboratory proficiency testing and clinical quality assessment of AIDS diagnostic reagents.
(3) Undertake HIV antibody confirmation, antibody screening and other AIDS testing in the areas designated by the provincial health administrative department.
(4) To carry out applied research and undertake testing tasks related to AIDS prevention and treatment in pathogenesis identification, on-site comprehensive prevention and treatment, research, monitoring, clinical treatment and other work.
(5) To establish a library of AIDS testing samples and quality control products within the scope of responsibilities.
(6) Collecting, organizing and analyzing AIDS testing data and related information, and establishing a basic database of AIDS testing laboratories and a database of AIDS testing information. Regularly report AIDS testing data and related information to the provincial health administrative departments and the Chinese Center for Disease Control and Prevention, and cooperate with them in case investigation, registration and other follow-up work.
(7) It is responsible for the technical support and guidance to the AIDS testing laboratories that carry out voluntary counseling and testing work.
2, AIDS confirmation laboratory functions
(1) Undertake the local health administrative department designated HIV antibody confirmation, antibody screening and other AIDS testing work.
(2) Report the confirmed positive results to the Laboratory of AIDS Confirmation Center in a timely manner, and cooperate with it to do a good job in case investigation, registration and other follow-up work.
(3) Undertake the tasks of operational and technical guidance, training and evaluation of AIDS testing and screening laboratories designated by the local health administrative departments.
(4) Regularly summarize AIDS testing information and report it to the laboratory of the AIDS confirmation center and the same level of the health administrative department.
(5) Assisting the AIDS testing laboratory to carry out voluntary counseling and testing, giving technical support and guidance.
(3) AIDS testing and screening laboratories.
Including AIDS screening center laboratory, AIDS screening laboratory and AIDS testing sites. AIDS screening center laboratory in the city (prefecture) level disease prevention and control centers; AIDS screening laboratory and AIDS testing sites can be located in disease prevention and control institutions, medical institutions, blood collection and supply institutions, family planning technical service institutions.
1, AIDS screening center laboratory functions.
(1) is responsible for HIV antibody screening test within the scope of responsibility, according to the need to carry out other AIDS testing.
(2) is responsible for HIV antibody screening positive samples sent to the AIDS test confirmation laboratory.
(3) Regularly summarize HIV testing information and report it to the Laboratory for Confirmation of HIV Testing. Cooperate with the Laboratory to do case investigation, registration and other follow-up work.
(4) Responsible for the technical guidance of the AIDS testing and screening laboratories within the scope of responsibility; assist the AIDS screening laboratories and AIDS testing sites to carry out voluntary counseling and testing work, and give technical support and guidance.
2, AIDS screening laboratory functions.
(1) to carry out HIV antibody screening test, according to the need to carry out other AIDS testing work.
(2) is responsible for HIV antibody screening positive samples sent to the local AIDS screening center laboratory or AIDS testing laboratory.
(3) Regularly summarize HIV test information and report it to the local HIV screening center laboratory or HIV test confirmatory laboratory.
(4) Provide technical support for voluntary counseling and testing.
3, AIDS testing site functions.
(1) To carry out screening tests for HIV antibodies.
(2) responsible for HIV antibody screening positive reaction of the sample sent to the local AIDS screening laboratory or AIDS screening center laboratory.
(3) Regularly summarize HIV test information and report it to the local AIDS screening laboratory or AIDS screening center laboratory.
(4) carry out AIDS voluntary counseling and testing. Article VII to carry out AIDS testing laboratories to undergo technical and conditions of acceptance, without acceptance or acceptance of unqualified laboratories shall not carry out AIDS testing work.
Article VIII of the establishment of AIDS testing laboratories or institutions shall submit an application to the provincial health administrative department.
Article IX provincial health administrative departments to organize expert groups in accordance with the "basic standards for AIDS testing laboratories" (see Annex), AIDS testing laboratories on the business capacity of personnel, facilities and conditions for acceptance.
(a) AIDS testing laboratory acceptance.
Provincial health administrative departments to organize expert groups to review the application materials, in line with the provisions of the applicant, complete materials, the organization of national experts to participate in the provincial AIDS testing laboratory acceptance expert group for on-site acceptance. Provincial health administrative departments for those who passed the acceptance issued a qualified notice, while copying the provincial disease prevention and control centers, those who did not pass the acceptance of rectification can re-apply.
(ii) acceptance of AIDS testing and screening laboratories.
Provincial health administrative departments to organize expert groups to review the application materials, in line with the provisions of the applicant, complete materials, by the provincial (or municipal) AIDS testing laboratory acceptance expert group to carry out on-site acceptance. Provincial health administrative departments of those who passed the acceptance issued a qualified notice, while copying the provincial CDC, those who did not pass the acceptance of rectification can re-apply.
Provincial health administrative departments in the organization of blood collection agencies practice acceptance, should be selected and sent to AIDS testing laboratory acceptance expert group experts to participate in the acceptance of blood collection agencies laboratory. Blood collection agencies to obtain permission to practice, copy the provincial Center for Disease Control and Prevention for the record.
Article X relocation of AIDS testing laboratories or change the category of AIDS testing laboratories, according to the above provisions of this approach to re-apply for acceptance.
Article XI of the provincial health administrative departments shall be AIDS testing laboratories acceptance of public announcement, and accept the supervision and inspection of relevant departments. Article XII AIDS testing laboratories shall carry out testing work within the scope of the specified functions and comply with national laws, regulations and relevant norms. Testing techniques and procedures should be in line with the requirements of the National Technical Specification for AIDS Testing.
Article XIII of the AIDS testing laboratory technicians need to go through the relevant business training, and those who pass the examination shall be issued training certificates by the relevant organizations and be licensed to work. Non-health professional and technical personnel shall not engage in AIDS testing.
Article XIV of the AIDS testing laboratories to use the state requires mandatory inspection of instruments and equipment, must be measured by the same level or higher level of certification department for regular verification, non-state mandatory inspection of instruments and equipment should be regularly required to manufacturers or supply departments for maintenance and calibration.
Article XV of the AIDS testing laboratory test reagents used must be registered by the State Food and Drug Administration, and meet the relevant requirements of the reagents.
Article XVI of the AIDS testing and screening laboratories found that HIV antibody screening positive samples must be promptly sent to the AIDS testing laboratory, and shall not be disposed of without authorization.
AIDS testing and confirmatory laboratories should be sent as soon as possible after the receipt of samples for confirmation of the test, the latest shall not exceed ten working days, except for one-time testing of a large number of samples and other special circumstances.
Article 17 The HIV antibody confirmation report issued by the HIV test laboratory shall be sent in a confidential manner. HIV antibody confirmation test results should be informed of the person; the person is incapable of behavior or limited capacity, should be informed of their guardians.
Article XVIII of the AIDS testing laboratories should be responsible for the proper preservation of testing records and various files, shall not be modified and destroyed. Record retention period of not less than ten years, national laws and regulations provide otherwise, in accordance with the relevant provisions.
Article 19 of the AIDS test shall abide by the principle of voluntary and informed consent, except as otherwise provided by national laws and regulations. HIV voluntary counseling and testing need to be in accordance with the "free voluntary counseling and testing of AIDS management approach (for trial implementation)".
Article 20 of the AIDS testing laboratory staff shall not disclose the names of AIDS patients or infected persons, address, test results and other relevant information. Article 30 The State Administration of Quality Supervision, Inspection and Quarantine in charge of entry-exit inspection and quarantine agencies and their supervision and management of AIDS testing. Entry-exit inspection and quarantine agencies in accordance with the standards and norms set out in this management approach, to determine the system to undertake entry and exit of people with AIDS testing laboratories, and laboratory acceptance of the local health administrative departments and disease prevention and control agencies copied.
Article 31 The army AIDS testing work by the People's Liberation Army health department in charge of supervision and management with reference to these measures. Armed Police Force AIDS testing work by the competent health department of the Armed Police Force in reference to the implementation of supervision and management of these measures.
Article 32 The Measures for the Acceptance of AIDS Testing Laboratories and the National Technical Specifications for AIDS Testing shall be separately formulated by the Chinese Center for Disease Control and Prevention.
Article 33 The meaning of the terms in these Measures is as follows:
AIDS testing: refers to the use of laboratory methods for human blood, other body fluids, tissues and organs, blood derivatives and other HIV, HIV antibodies and related immune indicators, including monitoring, inspection and quarantine, voluntary counseling and testing, clinical diagnosis, and blood and blood products screening work in the AIDS The test includes monitoring, inspection and quarantine, voluntary counseling and testing, clinical diagnosis, and blood and blood product screening.
AIDS testing laboratories: a collective term for all laboratories that test human blood, other body fluids, tissues and organs, blood derivatives, etc. for HIV, HIV antibodies and related immunity indicators.
Disease prevention and control institutions: refers to the Centers for Disease Control and Prevention (CDCs) engaged in disease prevention and control activities, as well as units with the same business activities as the above institutions.
Medical institutions: refers to the medical institutions in accordance with the "Regulations on the Administration of Medical Institutions" to obtain a license to practice medical institutions, engaged in disease diagnosis, treatment activities.
Blood Collection and Supply Institutions: Institutions that collect and provide clinical blood and raw plasma for production, including blood centers, central blood stations, central blood banks, special blood component banks, and single-collecting plasma stations.
Entry-Exit Inspection and Quarantine Organization: refers to the administrative and law enforcement organization responsible for entry-exit sanitary quarantine, animal and plant quarantine and commodity inspection, which consists of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (AQSIQ) and its established branches around the world.
Laboratory proficiency testing: the use of inter-laboratory comparison to determine the laboratory's testing capabilities.
Standard protection principle: refers to the medical staff will all patients' blood, other body fluids, as well as items contaminated by blood and other body fluids are regarded as contagious pathogenic substances, medical personnel in contact with these substances, must take protective measures.
Article 34 These Measures shall be interpreted by the Ministry of Health and shall come into force on the date of promulgation.
Article 35 Before the implementation of these measures have been officially approved by the AIDS testing laboratories will not be re-acceptance. 1997, the Ministry of Health issued the "National AIDS testing work norms" is repealed at the same time.
Annex: Basic Standards for AIDS Testing Laboratories