Standardized Laboratory Procedures, Quality Control and Quality Assurance Are Key Requirements for Accurate Semen Analysis in the Evaluation of Infertile Male

CAPSULE

Contributors: Ivan Hoffmann, MD (Germany), Safar Gamidov, MD (Russia), and Israel Maldonado, MS (Mexico)

Semen analysis is an essential and fundamental test for evaluating male fertility potential. Semen analysis is performed according to the current World Health Organization (WHO) criteria manually or automatedly with computer-aided sperm analytical system (CASA). emen analysis requires performance of highest quality, reliability, and accuracy as it contributes to the decision making of management and treatment of infertile couples. The workflow of semen analysis is divided into 3 phases: pre-analytical, analytical and postanalytical. Each phase implements particular steps that should be monitored. Each laboratory is required to establish quality indicators for laboratory equipment, standard operating procedures (SOP) and testing personnel and its surveillance. Quality control (QC) and quality assurance (QA) are important tools of the quality management system (QMS) that intends to achieve reproducible results.

QC monitors the accuracy and precision of a particular test or procedure whereas the purpose of the QA is the overall surveillance to ensure quality of procedures in a lab. The QMS defines quality indicators of all phases of the workflow of semen analysis and monitors the processes in order to meet this quality indicators. Both external and internal quality control (EQC and IQC) are important to evaluate quality in a laboratory. The IQC checks all critical points during the work routine to minimize the variability of an existing procedure within the laboratory. The EQC evaluates the laboratory performance by an external agency that commonly sends the same sample to different laboratories and compares the results of participating laboratories. It is essential to review, interpret and comment on the data collected by QC. The implementation of QA requires frequent and well-planned independent audits. Results of the audits must be reported. Reports must include any incident, error or deviation from the expected quality standard, its detailed description and record compliance, deficiencies and corrective actions taken.

CASA systems are automated or semi-automated instruments of semen analysis. The aim is to provide more precise results in a faster way than manual semen analysis. There are different CASA systems available using different mathematical algorithms. It is important to ensure that devices provide reliable results. Whether the semen analysis is manual or automated, its results significantly impact the management of an infertile couple. For example, there are patterns suggestive of seminal tract obstruction when surgical treatment could be indicated. Taken together, semen analysis and clinical data can be used to distinguish cases of male infertility associated with varicocele, metabolic syndrome, oxidative stress etc. By assessing these factors clinical andrologists should be able to determine whether the patient has indications of medical or surgical treatment, or the couple should proceed to ART right away. Semen analysis is a cornerstone of this decision-making process which places great responsibility on laboratory staff. According to the Code of Federal Regulations (42 CFR 493), Andrology labs need documented policies and procedures for a robust quality assurance (QA) program. Adherence to these standards, crucial for CLIA certification, ensures accurate, timely, and reliable test results. Maintaining staff competency, proper documentation of QA activities, and using standardized, reproducible methods are pivotal to guarantee high-quality outcomes in Andrology laboratories.

Summary: Understanding the principles and techniques for collecting and analyzing semen samples is crucial in clinical practice and infertility management. Strict quality control in andrology testing ensures consistent and reliable results. Accrediting agencies mandate proficiency test participation for reproductive labs conducting moderate to high complexity tests. Familiarity with normal semen parameter ranges and definitions of abnormal categories is vital for interpreting laboratory findings in

clinical settings.

Take Home Message:

Relying solely on manual semen analysis for infertile males poses challenges due to its subjectivenature, potential for variability among technicians, limited parameters assessed, time-consumingprocess, dependency on skilled personnel, inconsistencies in reporting, and the risk ofinaccuracies due to human error. Integrating automated or AI-based systems can help overcome these challenges by providing more consistent, comprehensive, and efficient assessments.

(Contributor: Ashok Agarwal, USA)