生殖实验室质量指标:SEF与ASEBIR质量利益集团良好临床实践手册

Miriam Iglesias , M. Carmen Gonzalvo , Ana Clavero , M. Luisa López-Regalado , José Muñoz , Luis Martínez-Granados , Purificación Navas-Bastida , Nereida Ortiz , José A. Castilla , Grupo Interés de calidad de ASEBIR
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摘要

由于辅助生殖技术的使用已成为常规,在寻求优化实验室结果方面的需求已发生变化,现在建立质量指标和标准具有根本重要性。因此,2016年出版了各种参考文献,例如ASEBIR质量兴趣小组(GICa-ASEBIR)发布的胚胎学实验室指标质量指南,以及最近由SEF伦理与良好实践兴趣小组(MBP-SEF)发布的《辅助生殖良好临床实践手册》。我们认为,仔细审查这些指标并确定哪些是这两份文件的共同指标将是有益的。为此,我们根据两个变量对指标进行了分类。首先,按类型(有效性和安全性),其次,按巧合程度:相似(在两份文件中都存在,定义相似);不一致(两份文件均有,但定义不一致);并且是唯一的(仅在两个文档中的一个中描述)。我们对两个文本的分析表明,8个有效性指标是相似的,3个是不同的。此外,发现1个安全指标存在差异,2个指标为GICa-ASEBIR文件独有,5个指标为MBP-SEF独有。这些结果突出了所提出的质量指标存在显著差异,我们认为有必要进行更大程度的标准化。
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Indicadores de calidad del laboratorio de reproducción: Manual de Buena Práctica Clínica de la SEF versus Grupo de Interés de Calidad de ASEBIR

Since the use of assisted reproduction techniques became routine, needs have changed in the quest to optimise laboratory results, and the establishment of quality indicators and standards is now of fundamental importance. For this reason, various reference texts have been published in 2016, such as the Embryology Laboratory Indicator Quality Guidelines issued by the ASEBIR Quality Interest Group (GICa-ASEBIR) and, more recently, the Handbook of Good Clinical Practice in Assisted Reproduction issued by the SEF Ethics and Good Practices interest group (MBP-SEF). We believe it would be useful to scrutinise these indicators and determine which ones are common to the two documents. To do so, we have classified the indicators according to two variables. Firstly, by type (effectiveness and safety) and secondly, by degree of coincidence: similar (present in both documents and similarly defined); discrepant (present in both documents but with discordant definitions); and unique (only described in one of the two documents). Our analysis of the two texts shows that eight indicators of effectiveness are similar and three are discrepant. In addition, one safety indicator was found to be discrepant, two indicators were unique to the GICa-ASEBIR document and five were unique to the MBP-SEF. These results highlight the presence of significant differences in the quality indicators proposed and the need, in our opinion, for greater standardisation.

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