Hervé P, Lapierre V, Morel P, Tiberghien P
Institut Gustave-Roussy, Villejuif.
Ann Med Interne (Paris). 1999 Dec;150(8):623-30.
Transfusion safety rests on measures ensuring that patients are transfused in accordance with the requirements of state-of-the-art scientific knowledge. This strict attitude is part of a quality approach which now applies to all fields of health. Transfusion is historically characterized by its ambivalence: it was the first medical discipline which integrated Quality Assurance concepts, it was also the first which proved unable to respond adequately in the face of uncontrolled risks. Today transfusion must create a system to rapidly: identify any risk, whether emergent or hypothetical; decide which action should be taken; monitor and assess corrective action; study the medico-economic impact of the whole approach. Quality assurance applies to every stage of the transfusion process, from blood donor to labile blood component recipient. This includes blood donor selection and biological control, labile blood component processing, qualification, transport and conditioning, prescription and distribution of blood components and transfused patient follow-up of. Quality controls, "safety locks", must be implemented at every stage to allow early problem detection, thus avoiding potentially dangerous attitudes and guaranteeing transfusion quality all along the process. Medical prescriptions must follow similar rules and meet Good Practice requirements defined by members of the medical and scientific community. A transfusion should not be prescribed unless it is absolutely necessary. In addition to sanitary surveillance, scientific surveillance must also be implemented to help transferring the findings of fundamental research to transfusion activities and continuously improve transfusion safety. INSERM is initiating sociological studies to identify and better understand donors' attitudes leading to risks. More sensitive tests based on nucleic acid amplification should reduce the incidence of residual viral risks. Various viral cell derivative inactivation techniques are being evaluated: the idea is to remove antigens to suppress the risk of post-transfusion alloimmunization. Numerous R&D; programs address substitution products. Transfusion safety requires all actors in the field of health being equally involved. Putting together experiences and know-how will continuously strengthen the quality approach adopted in transfusion.
输血安全取决于一系列措施，这些措施要确保患者按照最新科学知识的要求接受输血。这种严谨的态度是质量方针的一部分，如今已适用于医疗卫生的各个领域。从历史角度看，输血具有矛盾性：它是最早引入质量保证概念的医学学科，但也是最早面对无法控制的风险时难以充分应对的学科。如今，输血必须建立一个系统，以便迅速：识别任何风险，无论是突发的还是假设的；决定应采取何种行动；监测和评估纠正措施；研究整个方法的医学经济影响。质量保证适用于输血过程的每个阶段，从献血者到不稳定血液成分的接受者。这包括献血者的选择和生物学检测、不稳定血液成分的处理、鉴定、运输和储存、血液成分的处方和分发以及输血患者的后续跟踪。必须在每个阶段实施质量控制，即“安全锁”，以便早期发现问题，从而避免潜在的危险行为，并在整个过程中保证输血质量。医学处方必须遵循类似规则，并符合医学和科学界成员定义的良好实践要求。除非绝对必要，否则不应开具输血处方。除了卫生监测外，还必须实施科学监测，以帮助将基础研究的成果应用于输血活动，并不断提高输血安全性。法国国家健康与医学研究院正在开展社会学研究，以识别和更好地理解导致风险的献血者态度。基于核酸扩增的更灵敏检测应能降低残留病毒风险的发生率。正在评估各种病毒细胞衍生物灭活技术：其目的是去除抗原，以抑制输血后同种免疫的风险。众多研发项目致力于替代产品。输血安全要求医疗卫生领域的所有参与者共同参与。整合经验和专业知识将不断加强输血领域所采用的质量方针。
