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

Area of Science:

• Reproductive Medicine
• Clinical Laboratory Science
• Quality Control in Healthcare

Background:

• External quality control programs are crucial for standardizing laboratory performance.
• The German external quality control program for semen analysis (QuaDeGA) was established to improve diagnostic accuracy.
• Assessing laboratory performance and adherence to guidelines is essential for reliable semen analysis.

Purpose of the Study:

• To evaluate the performance of laboratories participating in the QuaDeGA program over its initial decade.
• To assess the impact of the QuaDeGA program on laboratory practices and adherence to World Health Organization (WHO) guidelines.
• To analyze trends in semen analysis techniques and their alignment with international standards.

Main Methods:

• Retrospective analysis of 19 QuaDeGA quality control distributions.
• Inclusion of data from 280 participating laboratories, primarily private urologic practices.
• Evaluation of laboratory responses against a defined
• target window
• and assessment of adherence to WHO guidelines for semen analysis.

Main Results:

• Participant numbers increased steadily, with private urologic practices forming the largest group.
• Adoption of WHO-recommended Neubauer chambers and diluents increased, while morphology staining protocols decreased.
• Less than 8% of laboratories fully complied with WHO guidelines; median-based ranking reduced performance variance but questioned ranking significance.

Conclusions:

• Laboratories demonstrate low adherence to WHO semen analysis guidelines, frequently employing non-recommended methods.
• Participation in the QuaDeGA program demonstrably improved laboratory performance.
• While median-based ranking reduces inter-laboratory variance, its impact on the meaningfulness of performance rankings requires further consideration.