Peter Ellis

The standard method for identification of male fertility status is a semen analysis. This is performed in fertility and pathology laboratories accredited by different bodies in the UK such as the HFEA or UKAS, and is based on whether they perform licenced clinical treatment or diagnostic testing. The WHO laboratory semen analysis criteria provide the most comprehensive guidance for best practice, yet this is not strictly adhered to. Our objective was to determine any differences in semen analyses between laboratories in the UK, based on the regulatory body they are registered with. A cross-sectional survey was sent to NEQAS for andrology registrants (n = 184 laboratories), HFEA (n = 117 clinics), and individual ARCS members (n = 682). Most ARCS members are associated with NEQAS and/or the HFEA. A ∼50% laboratory response rate (n = 106 included responses) was found. Results were grouped based on accreditation: Group 1, UKAS accredited only (n = 38); Group 2, both UKAS accredited and HFEA licenced (n = 17); Group 3, HFEA licenced only (n = 42); and Group 4, no accreditation (n = 9). Over 85% of UKAS accredited laboratories (Groups 1 and 2) state they perform semen analysis according to WHO 2010 recommendations and adhere to best practice guidelines. A significantly fewer number of HFEA only laboratories (<74% Group 3, p < 0.01 ) adhere to both guidelines. Non-HFEA laboratories (Groups 1 and 4) are almost all performing sperm counts according to WHO criteria, while <60% HFEA clinics (Groups 2 and 3) perform counts according to regulation (Group 1 vs. Groups 2 and 3: Fixed sperm, p < 0.05 ; Neubauer chamber: p < 0.005 ). QC is implemented in most laboratories, however there is a significant difference ( p < 0.01 ) between non-UKAS (Groups 3 and 4) and UKAS laboratories (Groups 1 and 2). There is a significant difference in semen analysis performance between UKAS and HFEA laboratories with regards to implementation of best practice guidelines and QC procedures. This may have a detrimental effect on result accuracy and consequently lead to patient misdiagnosis and mismanagement.