How strict should specimen acceptance or rejection criteria be for diagnostic semen analysis? An opinion

Medical laboratory accreditation (previously by Clinical Pathology Accreditation UK Ltd and now by the United Kingdom Accreditation Service) has been integral to improving standards and service quality in the UK. With the recent introduction of the ISO15189 standard, all laboratories offering a clinical diagnostic service are required to demonstrate further improvement, with more emphasis on validation and assessment of the uncertainty levels associated with testing. This applies not only to 'bench testing', but also to the evidence-base for all pre-analytical and post-analytical procedures. To reduce the risk of external influences on andrology test results, semen sample rejection criteria were developed, including confirmation of patient identity, a strict time limit from sample production to testing, the use of toxicity-tested containers, a prescribed sexual abstinence and a need for complete sample collection. However, such criteria were originally developed by the World Health Organization in order to standardise analysis rather than reject testing outright, and should therefore be implemented with caution. Rejecting samples with normal semen parameters because they fail to meet some of the criteria as outlined above would be a waste of resources and adversely affect user (the person who requested or provided the sample) satisfaction. This document evaluates the evidence base underlying commonly used criteria for specimen rejection and suggests how they may be applied more pragmatically in order to improve efficiency and reduce the waste of resources.