These newsletters aim to foster communication between LIMS developers and users, exploring best practices and challenges in laboratory information management. Each issue will discuss how our systems address these needs—both now and in the future.
Our first issue will cover the auto-verification (AV) process - what it is, what should ideally be in place to implement it and how Skylims answers these various challenges
Why use auto-verification?
Result verification is the process whereby laboratory personnel verify the overall acceptability of the test analysis outcome. It acts as the last quality assurance exercise in the laboratory before the results are released. Although interfaces between the instruments and LIMS have significantly reduced the chances for typing errors, manual verification is still a labourintensive process that introduces its own risks. It is a time-consuming process, and the quality of evaluation is often affected by fatigue, interruptions, distractions and varying levels of experience. (Edward W. Randell, 2019) Auto-verification is a workflow improvement tool aimed at reducing the number of tests that require review by a medical laboratory technologist. There have been many studies on this topic that proved its benefits: • Improving turn-around time by releasing results sooner. • Introducing more consistency in output and improving physician satisfaction. • Reducing workload and improving staff utilization. • Improving patient safety Research articles agree on a certain set of processes that should ideally be in place to implement auto-verification.
“If the laboratory implements a system for automated selection and reporting of results, it shall establish a documented procedure to ensure that: a) the criteria for automated selection and reporting are defined, approved, and readily available and understood by the staff…items for consideration when implementing automated selection and reporting include changes from previous patient values that require review and values that require intervention by laboratory personnel, such as absurd, unlikely or critical values.” ~ ISO 15189 addresses AV in section 5.9.2
Over the years, we have expanded and improved Skylims' auto-verification system.
I was curious to see how well our systems would adhere to these proposed processes - so I listed them out and provided the associated implementations
in Skylims:
| Requirement | Skylims Function |
|---|---|
| Instrument Flags Many instruments will flag results when the testing process encountered errors or problems (e.g., Contamination) during analysis. |
Skylims’ interfacing allows for capturing errors reported by instruments and flagging the results on Skylims – making these errors visible, preventing auto-verification. |
| QC The instrument should pass all quality control checks for an analyte before the system can auto-verify the results |
Skylims tracks and integrates the QC status of analytes into our requisition form. Limiting auto-verification to analytes that passed their QC checks. |
| Delta Checks Compares the current and previous result of a test and evaluate the probability of significant change. |
Skylims supports setup of delta-checks which would prevent autoverification for results with significant change. |
| Critical Results Critical or life-threatening results may need further attention from the laboratory staff |
In Skylims, you can set up reference ranges for critical vs. lifethreatening results. Tests can also be set up to only auto-verify normal results. |
| Limit Check These checks identify results that exceed some predefined limits. |
We also have reference range settings for hold and impossible values that can stop processing pending further laboratory investigations. |
| Consistency Checks These are cross-checks involving multiple correlated tests. e.g, Serum Urea and Creatinine are significantly affected by renal functions - so changes in one will likely be accompanied by changes in the other. (A ratio between the two can be held within a relatively narrow range (Edward W. Randell, 2019)) |
Skylims boasts a powerful test-rule system that allows you to consider the results of multiple tests before verifying. |
| HIL Indices Checks Hemolysis, Icterus and Lipemia index of a sample can affect the analysis of a test - often resulting in faulty reporting. |
Flag-on-verification rules can be set up to limit verification to acceptable HIL-indices. Ideally, HIL-indices should be evaluated before the affected tests are released. Skylims is set up to only auto-release once all tests for a site have been verified, allowing the system to perform more comprehensive checks. |
| Post implementation monitoring Researchers suggest monitoring autoverification effectiveness after implementation. (Edward W. Randell, 2019) Such a process is typically iterative. AV Pass-rate is a commonly used metric for AV efficiency. |
Mukon offers development of - and support for power bi reports to help laboratory practices analyse their turn-around-times and the effectiveness of processes like AV. |
References
- Edward W. Randell, S. Y. (2019). Autoverification of test results in the core clinical laboratory. Clinical Biochemistry, 11-25.
- Hanjing Hou, R. Z. (2024). Artificial intelligence in the clinical laboratory. Clinica Chimica Acta, 119724.
- Hikmet Can Çubukçu, F. V.-A. (2021). Improving the laboratory result release process in the light of ISO 15189:2012 standard. Clinica Chimica Acta, 167-173.
- Rashmi Rasi Datta, A. B. (2024). Clinical Chemistry and Autoverification: A Path Less Traversed. OpenAccess.