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Related Experiment Videos

The application of quality systems in ART programs.

M Wikland1, C Sjöblom

  • 1Fertility Center of Scandinavia, Calanders Hospital, Göteborg, Sweden. matts.wikland@fcivf.com

Molecular and Cellular Endocrinology
|September 16, 2000
PubMed
Summary

Implementing a quality control system in an assisted reproductive technology (ART) laboratory ensures method reproducibility and personnel competence. This accreditation process standardized laboratory procedures and optimized the handling of gametes and embryos.

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Area of Science:

  • Reproductive Medicine
  • Laboratory Science
  • Quality Management Systems

Background:

  • Assisted reproductive technology (ART) units require robust quality control (QC) systems to ensure method reproducibility and personnel competence.
  • Potential risks in ART highlight the critical need for standardized procedures and clear protocols.
  • QC principles, originating in industry, are applicable to healthcare services, including clinical testing laboratories.

Purpose of the Study:

  • To establish and implement a comprehensive quality control system within an IVF laboratory.
  • To achieve accreditation based on European Norm (EN) 45001 and ISO/IEC Guide 25 standards.
  • To enhance the standardization and optimization of laboratory practices in ART.

Main Methods:

  • Documentation of all laboratory routines and methods.

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  • Development of a quality manual detailing the QC system.
  • Submission of an accreditation application to the Swedish Board for Accreditation and Conformity Assessment (SWEDAC).

    • Main Results:

    • The ART laboratory successfully obtained accreditation according to EN 45001 and ISO/IEC Guide 25.
    • Implementation of the QC system led to standardized methods and embryologist procedures.
    • The laboratory environment for handling patient gametes and embryos was optimized.

    Conclusions:

    • A formal quality control system is essential for maintaining high standards in ART laboratories.
    • Accreditation provides external validation of laboratory competence and procedural consistency.
    • Standardization and optimization through QC enhance the reliability and safety of ART procedures.