Acceptable variability in external quality assessment programmes for basic semen analysis.

Area of Science:

• Andrology
• Laboratory Medicine
• Quality Assurance

Background:

• External quality assessment programs (EQAPs) are vital for andrology laboratories.
• Establishing acceptable variability limits is essential for assessing laboratory proficiency.
• Current limits often depend on individual EQAP organizers' criteria.

Purpose of the Study:

• To evaluate ISO 13528:2005 criteria for calculating acceptable variability in semen analysis EQAPs.
• To compare different methods for determining acceptable variability ranges.

Main Methods:

• Utilized means and standard deviations from national and international EQAPs.
• Calculated acceptable variability using four ISO 13528:2005 criteria: (i) all lab SDs, (ii) expert lab SDs, (iii) quality specifications (biological variability, state-of-the-art, clinical opinion), and (iv) specifications adjusted for uncertainty.
• Compared the resulting variability ranges.

Main Results:

• Criteria based on all or expert lab standard deviations yielded excessively wide variability ranges.
• Quality specifications alone resulted in very narrow ranges.
• Adjusting specifications for uncertainty produced intermediate ranges, with minimal differences between strategies (iii) and (iv) regardless of the analytical quality model used.

Conclusions:

• EQAPs for semen parameters must establish clinically useful acceptable variability ranges.
• The definition of 'expert laboratory' significantly impacts the outcome, more so than the analytical quality specification model.
• Ensuring minimal negative impact on clinical decisions is paramount for EQAP results.