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Related Experiment Videos

Achieving and maintaining quality in the laboratory.

M S Hertzberg1, J Mammen, A McCraw

  • 1Department of Haematology, ICPMR and Haematology RCPA QAP, Westmead Hospital, Westmead, NSW, Australia. mark_hertzberg@wmi.usyd.edu.au

Haemophilia : the Official Journal of the World Federation of Hemophilia
|May 11, 2006
PubMed
Summary

Laboratories must use internal quality control (QC) and external quality assessment (EQA) for high-quality services. Genetic testing EQA reveals errors, particularly in mutation naming, highlighting standardization needs.

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Area of Science:

  • Clinical Laboratory Science
  • Molecular Diagnostics
  • Quality Management Systems

Background:

  • High-quality laboratory services depend on robust internal quality control (QC) and external quality assessment (EQA) participation.
  • Internal QC involves establishing reference intervals (95% range) for assessing abnormal test results.
  • External quality assessment (EQA) evaluates laboratory performance in proficiency testing.

Purpose of the Study:

  • To examine the quality control and assurance measures in laboratory testing, with a focus on genetic testing.
  • To identify common sources of errors in genetic testing EQA programs.
  • To highlight challenges faced by developing countries in implementing effective EQA programs.

Main Methods:

  • Review of quality control principles in laboratory diagnostics.

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  • Analysis of error types reported in genetic testing EQA schemes.
  • Discussion of challenges in EQA participation and logistics, especially for developing nations.

    • Main Results:

    • Genetic testing EQA programs reveal errors stemming from sample mix-ups, transcription mistakes, and analytical errors.
    • Mutation naming errors are prevalent in DNA sequencing-based EQA, indicating a lack of standardization.
    • Developing countries encounter significant logistical and financial hurdles in establishing and maintaining EQA programs.

    Conclusions:

    • Consistent application of internal QC and EQA is crucial for reliable laboratory diagnostics.
    • Standardization of nomenclature and improved analytical methods are needed in genetic testing.
    • Addressing logistical and financial barriers is essential to promote EQA participation globally, particularly in developing regions.