Ten years' experience with an external quality control program for semen analysis

Abstract

Objective: To gauge the performance of laboratories and impact of the German semen analysis external quality control program (QuaDeGA) over its first 10 years.

Design: Retrospective analysis of QuaDeGA's twice yearly distribution of fixed semen samples and electronic material documenting sperm motility. Ranking of each participant's responses was determined according to their relation to a "target window."

Setting: Multicenter. PAITENT(S): Healthy donors.

Intervention(s): None.

Main outcome measure(s): Laboratory performance, World Health Organization (WHO) adherence.

Result(s): Over 19 runs, there was a steady increase of participants (280 laboratories), the largest group being private urologic practices. Although use of WHO-recommended Neubauer chamber (from 33% to 55%) and diluent (from 11% to 32%) increased, the opposite occurred with morphology staining protocols (from 41% to 19%). Overall, <8% of laboratories truly followed WHO guidelines. Median-based comparisons, replacing reference laboratories, resulted in a merging of performance rankings regardless of the protocols used.

Conclusion(s): Adherence to WHO recommendations is low, with the majority of laboratories using methods expressly opposed by the guidelines. Participation in QuaDeGA was found to improve the performance of the laboratories involved in the program. However, the use of median-based ranking, while decreasing the extent of variance between laboratories, brings into question the significance of the rankings.