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Laboratory information systems (LISs) lack essential molecular workflow functions, impacting efficiency and security. Addressing these gaps is crucial for high-quality molecular diagnostics as testing volume increases.

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Area of Science:

  • Clinical Laboratory Science
  • Molecular Diagnostics
  • Health Informatics

Background:

  • Laboratory Information Systems (LISs) are critical for managing laboratory data.
  • Molecular diagnostics workflows have unique data management and security needs.
  • Existing LIS functionalities may not adequately support advanced molecular testing.

Purpose of the Study:

  • To identify critical functionality gaps in LISs for molecular laboratories.
  • To assess the impact of these gaps on workflow, efficiency, and data security.
  • To inform LIS and instrument manufacturers about necessary improvements.

Main Methods:

  • An anonymous online survey was distributed to clinical laboratory professionals.
  • The survey included 34 questions covering demographics, testing scope, and software capabilities.
  • Data from 80 respondents were analyzed to identify functionality deficits.

Main Results:

  • Significant gaps were found in barcoding, LIS interfacing, and preanalytical data storage.
  • Health Insurance Portability and Accountability Act (HIPAA) compliance and information security were major concerns.
  • Many molecular LISs and instrument software lack basic, essential functionalities.

Conclusions:

  • Current LISs and instrument software present substantial deficits for molecular laboratory workflows.
  • Non-compliance with HIPAA regulations was indicated in some systems.
  • Collaboration between molecular professionals and software/instrument manufacturers is vital to enhance quality and safety.