Accreditation and the use of validated/recognised methods to analyse human semen

Area of Science:

• Laboratory Medicine
• Reproductive Health
• Quality Management Systems

Background:

• Accreditation for diagnostic semen analysis laboratories in Australia and New Zealand is mandated by the healthcare system.
• Laboratories must adhere to International Organization for Standardization (ISO) standards within their operational policies.
• Accurate and repetitive measurement of semen parameters, particularly near reference interval limits, is crucial for diagnostic accuracy.

Purpose of the Study:

• To outline the requirements for validating variations in semen analysis methods within accredited laboratories.
• To emphasize the importance of documented validation processes and statistical analysis for method variations.
• To address the need for in-house reference intervals when validated methods significantly differ from World Health Organization (WHO) manual standards.

Main Methods:

• Laboratories utilize World Health Organization (WHO) manual methods as the universal standard for semen analysis.
• Minor variations to WHO methods may be incorporated into laboratory procedures.
• All method variations require documented validation using internally approved processes, including statistical analysis and result comparison.

Main Results:

• Validation is an ongoing process requiring regular review and must be available for external accreditation audits.
• Validated variant methods that yield significantly different results compared to WHO manual methods require further action.
• Laboratories must develop and implement their own in-house reference intervals for such validated variant methods.

Conclusions:

• Rigorous validation of all semen analysis methods, including variations from WHO standards, is essential for laboratory accreditation.
• Documented validation ensures the reliability and accuracy of diagnostic semen analysis.
• The development of in-house reference intervals is a critical step when validated methods deviate from established WHO guidelines, ensuring appropriate patient care.