Validation in the cytopathology laboratory: its time has come

Area of Science:

• Cytopathology
• Laboratory Medicine
• Clinical Diagnostics

Background:

• Traditionally, cytology labs performed limited manual tests.
• Limited instrumentation and infrequent performance checks were common.
• Lack of documentation for instrument validation was prevalent.

Purpose of the Study:

• Highlight the shift towards automation and expanded testing in cytopathology.
• Emphasize the critical need for validation of new instruments and methods.
• Advocate for adopting validation practices similar to clinical laboratory colleagues.

Main Methods:

• Review of traditional and current cytopathology laboratory practices.
• Discussion of increasing automation, new devices, and molecular testing.
• Comparison with validation standards in broader clinical laboratory settings.

Main Results:

• Cytopathology practice has significantly evolved with automation and new technologies.
• New instrumentation and molecular tests require rigorous validation.
• Validation is essential for ensuring accuracy and consistency in cytopathology testing.

Conclusions:

• Cytopathology laboratories must embrace validation of tests and instruments.
• Understanding and applying validation principles is crucial for patient care.
• Adopting validation practices ensures the reliable use of complex testing and instrumentation.