Subsection 2: Biological analyses and screening tests.

The following biological analyses and screening tests are carried out for each donation of blood or blood components intended for the preparation of labile blood products for direct therapeutic use: 1° Erythrocyte blood grouping, which includes : a) Determination of ABO and Rh(D) groups, also known as Rh 1 (RH1) ; b) Determining the Rh phenotype: C(RH2), E(RH3), c(RH4) and e(RH5) and Kell(KEL1) for the first two donations; 2° Testing…

Blood or its components may only be used to prepare labile blood products intended for direct therapeutic use if the results of the screening tests provided for in 5° of article D. 1221-6 are negative.

Derogations from the provisions of articles D. 1221-6 and D. 1221-7 may be provided for by order of the Minister for Health, when blood or its components are collected with a view to preparing labile blood products intended for programmed autologous transfusion.

An order of the Minister for Health may provide for : 1° Biological analyses and screening tests to be carried out for the selection of red cell donors intended to stimulate the synthesis of anti-D antibodies in Rh-immunised plasma donors with a view to the preparation of anti-D immunoglobulins; 2° Biological analyses and screening tests to be carried out for the selection of Rh-immunised plasma donors with a view to…

By way of derogation from the provisions of articles D. 1221-6 to D. 1221-8, an order of the Minister for Health lays down the conditions under which, in order to meet overriding therapeutic needs or to take account of the rarity of certain erythrocyte blood groups, labile blood products for direct therapeutic use, prepared from blood or blood components which have not undergone all the tests and analyses mentioned in…

Any blood establishment collecting blood and its components, which prepares labile blood products intended for the preparation of intermediate products or medicinal products derived from blood, is required to apply the tests and analyses referred to in 4° and in b, c, d, e, g and h of 5° of article D. 1221-6 to the corresponding samples. Blood or its components may only be used for the purposes mentioned in…

Blood and its components may only be used to prepare in vitro diagnostic medical devices if the results of the tests and analyses provided for in b, c and d of 5° of Article D. 1221-6 are negative. However, an in vitro diagnostic medical device may be manufactured from a sample containing one or more antibodies or antigens sought by the tests and analyses mentioned in the above paragraph and…

Blood and its components may only be transferred to an educational establishment or vocational training organisation for teaching purposes, to the exclusion of any administration to humans, and on condition that: -the tests and analyses provided for in 5° of article D. 1221-6 have been carried out on each sample; -the results comply with the provisions of article D. 1221-7.