Informatics, digital & computational pathology

• Design of AV systems
  • Select AV software (middleware / LIS)
  • Assemble a multidisciplinary team that includes medical directors, supervisors, MLTs and information technology (IT) staff
  • Develop AV algorithms
    • Review current laboratory practices and avoid automating procedures that add no value
    • Laboratories with limited experience in AV should begin with simple algorithms
    • Higher AV pass rates can be achieved by implementing more complex algorithms after acquiring experience
    • Rule types comprising AV algorithms can range from numerical verification intervals to cascading boolean rule sets
    • Machine learning based approaches have been described; however, these approaches are unlikely to replace current practices in the near future (Clin Lab Med 2023;43:47)
  • Complete AV programming and convert rules to computer code
• Validation of AV algorithms is required before implementation and occurs in 2 phases
  • Wet testing
    • Performed by analyzing samples meeting the desired criteria on the appropriate instruments and passing them through the AV system
    • Samples meeting the criteria to test the AV rules may be difficult to obtain and can be generated by manipulating native samples (spiking, diluting, adding interferents)
  • Dry testing
    • Performed using simulated results or selecting results that meet the desired criteria from previously run samples
    • Simulated results should be indistinguishable from those released from the instrument
• Implementation
  • AV systems should be intensively audited for several days following initial implementation and periodically after that
  • AV algorithms require revalidation any time changes are made (CAP GEN.43875)
  • Laboratories should maintain records of initial AV system validation and validation of any changes following implementation including thorough audit trails
  • AV rules adopted by the lab should be readily available and understood by laboratory staff
  • Results held for manual review should be identifiable for retrospective review
  • Process to suspend the AV system is necessary and should be documented
  • Monitor AV performance and continuously improve algorithms
    • Test and report based AV pass rates should be monitored

Images hosted on other servers:

What is autoverification (AV) in the clinical laboratory?

1. A procedure used to verify new algorithms that are used for reporting test results
2. A process related to reporting test results which is required for CLIA certification
3. The process of using computer based rules to evaluate and validate laboratory results without human interaction
4. The process of using patient results to verify the integrity of new reagents on high throughput chemistry analyzers

C. The process of using computer based rules to evaluate and validate laboratory results without human interaction. AV accomplishes 2 things: 1) releases patient results that do now require intervention and 2) identifies samples that require manual review by a medical laboratory technologist. Answer A is incorrect because AV is the process of using computer based rules to evaluate and validate laboratory results without human interaction, not a procedure used to verify new algorithms that are used for reporting test results. Answer B is incorrect because AV is not required for CLIA certification. Answer D is incorrect because reagent verification is not part of AV.

Comment Here

Reference: Autoverification in the core clinical laboratory

Which of the following are advantages of using autoverification (AV)?

1. Can improve the accuracy of test results in the clinical laboratory
2. Can improve turnaround time, staff utilization, operational efficiency and error detection rates in the clinical laboratory
3. Can reduce the reagent consumption of chemistry analyzers
4. Improves staff satisfaction, result accuracy and the efficiency of reagent use

B. Can improve turnaround time, staff utilization, operational efficiency and error detection rates in the clinical laboratory. Answer A is incorrect because AV does not affect the analytical accuracy of test results. Answer C is incorrect because AV does not affect the amount of reagent consumed. Answer D is incorrect because AV does not affect result accuracy or efficiency of reagent usage.

Comment Here

Reference: Autoverification in the core clinical laboratory