Achieving and maintaining quality in the laboratory

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.
• 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.