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引用次数: 0
摘要
这些良好操作建议的主要目的是对2018年5月15日法令的监管规定进行补充,该法令规定了在医学生物学中进行红细胞免疫血液学检验的条件,以明确其对进行一线免疫血液学检验(红细胞表型和抗红细胞抗体检测)的医学实验室的适用性。这些建议涵盖了《公共卫生法》(第 L6211-2 条)中规定的生物检查的所有阶段(分析前、分析中和分析后)。建议分为四个等级:推荐实践:符合 NF EN ISO 15189:2022 标准的要求,确保提供最佳医疗服务。可接受的实践:偏离免疫血液学最佳实践的情况,但仍能确保令人满意的患者管理以及输血和产科安全。非推荐做法:不符合 NF EN ISO 15189:2022 标准的要求,无法对患者进行满意的管理,但仍能确保输血和产科安全。不可接受的操作:存在输血或产科并发症风险。遵守这些建议可优化患者医疗护理,尤其是在输血或产科情况下。
[Recommendations for first-line immuno-hematology examinations by medical laboratories].
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.