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在新建的体外受精实验室建立质量控制。

Establishing quality control in the new IVF laboratory.

作者信息

Cutting Rachel, Pritchard Jane, Clarke Helen, Martin Karen

机构信息

Assisted Conception Unit, Centre for Reproductive Medicine and Fertility, Jessop Wing, Sheffield, UK.

出版信息

Hum Fertil (Camb). 2004 Jun;7(2):119-25. doi: 10.1080/14647270410001709188.

Abstract

The ability to create an optimal environment for the culture of oocytes and embryos is important to ensure that embryo viability, and therefore pregnancy outcome, is not compromised. Laboratory performance can be monitored using a quality control system. In setting up a new IVF unit, a comprehensive quality control programme was established to monitor laboratory performance and to detect any problems that potentially may have resulted in a sub-optimal service. The measures employed were designed to optimize the environment for human embryo culture by providing aseptic conditions and security for the gametes and embryos, whilst providing a safe working environment for laboratory staff. Equipment function, consumables and environmental parameters were assessed prior to the commencement of treatment in the new unit. A mouse embryo bioassay was used to assess the ability of the new laboratory and equipment to support mammalian embryo development. Prior to the start of clinical treatments a quality control program highlighted equipment that was functioning sub-optimally, which had the potential to cause problems had it been left undetected. Once clinical treatment commenced, quality control monitoring was continued to ensure that the laboratory functioned to a consistently high standard.

摘要

为卵母细胞和胚胎培养创造最佳环境的能力对于确保胚胎活力以及妊娠结局不受影响至关重要。可使用质量控制体系来监测实验室性能。在新建一个体外受精(IVF)单元时,制定了一项全面的质量控制计划,以监测实验室性能并检测任何可能导致服务欠佳的问题。所采用的措施旨在通过为配子和胚胎提供无菌条件及安全保障,同时为实验室工作人员提供安全的工作环境,来优化人类胚胎培养环境。在新单元开始治疗前,对设备功能、耗材和环境参数进行了评估。使用小鼠胚胎生物测定法来评估新实验室和设备支持哺乳动物胚胎发育的能力。在临床治疗开始前,质量控制计划突出显示了功能欠佳的设备,如果未被发现,这些设备有可能引发问题。一旦临床治疗开始,便继续进行质量控制监测,以确保实验室始终保持高标准运作。

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