[Recommendations for first-line immuno-hematology examinations by medical laboratories].

Abstract

The main objective of these recommendations for good practices is to supplement the regulatory provisions of the decree of May 15, 2018 which sets the conditions for performing erythrocyte immunohematology tests in medical biology, in order to clarify their application for medical laboratories which conduct first-line immunohematology tests: erythrocyte phenotyping and detection of anti-erythrocyte antibodies. These recommendations cover all phases of a biological examination (pre-analytical, analytical, and post-analytical) as defined in the Public Health Code (Article L6211-2). Four levels of recommendations have been established: ● Recommended practices: complying with the requirements of the NF EN ISO 15189:2022 standard and ensuring optimal medical service delivery. ● Acceptable practices: situations which deviate from the best practices in immunohematology but still ensuring satisfactory patient management as well as transfusion and obstetrical safety. ● Non-recommended practices: not complying with the requirements of the NF EN ISO 15189:2022 standard and not allowing satisfactory patient management, but ensuring transfusion and obstetrical safety. ● Unacceptable practices: presenting a risk for transfusion or obstetrical complications. Compliance with these recommendations optimizes patient medical care, particularly in transfusion or obstetrical contexts.