ART Audits Australasia, Northbridge, New South Wales, Australia.
Reprod Biol. 2011 Dec;11 Suppl 3:5-15.
Accreditation of laboratories who perform diagnostic semen analysis in Australia and New Zealand is a requirement of the healthcare system. Within the accreditation process laboratories are required to set ISO standards within their policies and procedures. In order to achieve their aims, laboratories need to be able to measure a number of defined semen parameters both accurately and repetitively, especially around the lower limit of the reference intervals. The methods documented in the WHO-manual are used almost universal as the laboratory standard. Some laboratories incorporate minor method variations into their procedures. As part of the ISO requirements all variations require validation using internally approved processes that are documented and that incorporate appropriate statistical analysis and comparison of results. Validation is an ongoing process and regular review is essential. Evidence of the validation must be available for review by external auditors during accreditation. Where any validated variant method returns results that are significantly different to any method within the WHO-manual, the laboratory needs to develop its own, in-house reference interval for that method.
在澳大利亚和新西兰，进行诊断性精液分析的实验室的认证是医疗保健系统的要求。在认证过程中，实验室需要在其政策和程序中设定 ISO 标准。为了实现目标，实验室需要能够准确且重复地测量许多定义明确的精液参数，特别是在参考区间的下限附近。世界卫生组织手册中记录的方法几乎被普遍用作实验室标准。一些实验室将一些微小的方法变化纳入其程序中。作为 ISO 要求的一部分，所有变化都需要使用经过内部批准的过程进行验证，这些过程都有记录，并包含适当的统计分析和结果比较。验证是一个持续的过程，定期审查至关重要。在认证过程中，必须提供验证的证据供外部审核员审查。如果任何经过验证的变体方法的结果与世界卫生组织手册中的任何方法有显著差异，实验室则需要为该方法开发自己的内部参考区间。
