Article – Order of June 16, 2021 setting the conditions for carrying out rapid diagnostic orientation tests for infection by human immunodeficiency viruses (HIV 1 and 2) and infections by hepatitis C viruses (HCV) ) and hepatitis B (HBV), in medico-social or associative settings and other authorized centers and establishments

APPENDIX V
THE APPLICATION FILE OR ADDITIONAL AUTHORIZATION FOR ASSOCIATIONS

The authorization request file must contain all the elements making it possible to ensure that the associative structure involved in health prevention or reduction of the risks and damages associated with the consumption of psychoactive substances is able to comply with the prescriptions. of the specifications determined in Annex II. This file includes the following information:

1. General information

– authorization requested for the use of rapid diagnostic orientation tests (TROD):

– infection with hepatitis B virus (HBV -AgHBs) □;
– infection with hepatitis C virus (HCV) □;
– infection with human immunodeficiency viruses □;

– name of the associative structure;
– legal form and statutes of the structure;
– name and position of the person responsible for carrying out rapid diagnostic orientation tests (TROD) for HCV or HBV infection or HIV 1 and 2;
– other activities of the structure.

2. Description of the objectives and the public targeted by the screening offer

– description of the expected results of the proposed screening offer and its insertion in the locoregional context of screening offer (cf. paragraph 10 of the specifications);
– description of the public targeted by this offer.

3. Staff information

– list of names and quality of people dedicated to the activity; provisional distribution of their roles;
– procedures for training (internal or external) and updating the skills of personnel carrying out rapid diagnostic orientation tests for HCV or HBV infection or HIV 1 and 2.

4. Information relating to intervention sites and equipment

– mention of fixed or mobile premises and places of intervention;
– type / brand of rapid diagnostic orientation tests for HCV or HBV infection or HIV 1 and 2 and matrices used;
– storage procedures for these rapid diagnostic orientation tests;
– methods of managing the IHCW produced (agreement with the collection and disposal service provider).

5. General operating conditions

– opening hours of fixed places; hotline ; signage envisaged;
– organization planned for the performance of the tests: procedures governing the reception and information of the target public, the collection of the consent of the person concerned, the technical performance and the delivery of results; documents given to the person;
– description of the conditions guaranteeing the confidentiality of exchanges with the person received inside the fixed or mobile premises serving as places of intervention;
– conditions of referral and support of people to a doctor, a health establishment or service, a medical biology laboratory for confirmation of the result of the rapid diagnostic referral test for HCV or HBV infection or to HIV 1 and 2 and medical treatment, if necessary;
– data retention conditions ensuring the confidentiality of information;
– formalized agreements with one or more free information, screening and diagnostic centers (CeGIDD), one or more health establishments or services (including PASS) likely to take care of people with hepatitis B or C or HIV or to provide prophylactic treatment if there is a recent risk of transmission of HIV or HBV;
– articulation with the network of professionals in the prevention, screening and treatment of infections by hepatitis B or C or by HIV as well as other associations of patients or users of the health system, as coordinated by the ‘ARS, in conjunction with the coordinating committee for the fight against human immunodeficiency virus infection (COREVIH) and with an expert service for the fight against viral hepatitis (SELHV) in whose territory the establishment.

6. Quality assurance procedure

Provide the document describing the quality assurance procedure as defined in paragraph 12 of Annex II.

7. Funding methods envisaged

Provide the provisional budget for the structure and the method of financing rapid diagnostic orientation tests for HCV or HBV infection or HIV 1 and 2.

8. Certificates to be provided

– certificates of training follow-up for staff dedicated to carrying out rapid diagnostic orientation tests for HCV or HBV or HIV 1 and 2 infection in the associative structure;
– civil liability insurance taken out by the structure for carrying out rapid diagnostic orientation tests for infection by HCV or HBV or HIV 1 and 2.

9. Request for additional authorization to the existing authorization for the use of TROD for HIV 1 and 2 infection or HCV

When the associative structure already has authorization for the use of TRODs for HIV 1 and 2 infection and / or HCV and wishes to have additional authorization to be able to use TRODs for the detection of HIV HBs antigen for HBV infection, the additional request file must include the following information or documents:

– a letter requesting additional authorization for the use of TRODs other than those for which the structure is authorized;
– any modification of the information contained in the previous authorization file concerning general information on the associative structure, the methods of keeping these TRODs, the methods of management of the DASRI products, the general operating conditions, the quality assurance procedure ;
– the objectives and description of the public targeted by the screening offer;
– the list of names and the quality of the persons trained in the use of the TRODs requested in additional authorization;
– the procedures for training and updating the skills of personnel carrying out TRODs;
– the mention of fixed or mobile premises and places of intervention planned;
– the types and brands and the dies used, for the TRODs requested in additional authorization;
– the provisional budget of the structure and the method of financing the TRODs requested in additional authorization;
– Complementary training follow-up certificates for personnel dedicated to carrying out the TRODs requested in additional authorization in the associative structure;
– civil liability insurance taken out by the structure for carrying out the TRODs.