Molecular genetic testing laboratory management: emerging challenges for quality assurance

Area of Science:

• Molecular diagnostics
• Laboratory management
• Quality assurance

Background:

• Molecular genetic testing laboratories have historically faced significant adaptation challenges.
• These challenges stem from rapid technological advancements, increasing test demand, evolving regulations, and shifting best practices.
• Future challenges are expected to intensify due to new clinical applications, global regulatory harmonization needs, and growing demand in developing nations.

Purpose of the Study:

• To provide an overview of the historical development of quality management frameworks in molecular genetic testing.
• To familiarize readers with standardization practices in molecular genetic testing laboratory management.
• To identify persistent dynamics that have challenged quality assurance in the field.

Main Methods:

• This is a review article.
• It synthesizes historical information on quality management and standardization.
• It identifies recurring themes and challenges in quality assurance.

Main Results:

• The field has seen progress, but challenges persist and are likely to increase.
• New clinical uses and global demand will exacerbate cost and efficiency pressures.
• Adaptable quality assurance frameworks are essential for future success.

Conclusions:

• Continuous adaptation of quality assurance frameworks is paramount for molecular genetic testing laboratories.
• Scholars, policymakers, and laboratory managers must prioritize efforts to enhance framework effectiveness and adaptability.
• Addressing cost and efficiency pressures requires strategic improvements in quality management.