Abstract
Autoverification releases a clinical chemistry result to the requesting clinician without manual review when it passes a defined set
of rules, and its safe operation depends entirely on how those rules are designed, tuned and audited rather than on the
autoverification software itself. We describe the rule-design framework used at our centre across 42 chemistry analytes, covering
delta checks, absolute limit checks, critical-value exclusions and consistency checks between related analytes, and report a
twelve-month audit of every result the system released. Autoverification released 89.6% of chemistry results without manual
review, and a monthly audit sample of manually re-reviewed autoverified results found a false-release rate -- a result released that
a reviewer would have held -- of 0.31%, concentrated almost entirely in three analytes whose rule sets were subsequently
tightened. We set out the rule categories, the audit method, and the governance structure needed to keep an autoverification rule
set safe as reagent lots, analyser platforms and patient case mix change over time.
References
Torke N, Boral L, Nguyen T, et al. "Process improvement and operational efficiency through test result autoverification". Clin Chem 51(2005): 2406-2408.
Randell EW, Yenice S. "Delta checks in the clinical laboratory". Crit Rev Clin Lab Sci 56(2019): 75-97.
Wheeler TL, Yamada A, Yang W, et al. "Optimization of delta check rules for autoverification". Am J Clin Pathol 145(2016): 388-395.
Guidi GC, Poli G, Bassi A, et al. "Development and implementation of autoverification rules with delta check limits". Clin Chem Lab Med 50(2012): 715-719.
CLSI. "Autoverification of clinical laboratory test results; approved guideline". CLSI document AUTO10-A. 2006.
Krasowski MD, Davis SR, Drees D, et al. "Autoverification in a core clinical chemistry laboratory at an academic medical center". J Pathol Inform 5(2014): 13.
Fung KS, Chan SL, Tam FKY. "Effective use of autoverification and delta checks in laboratory quality management". Clin Chim Acta 500(2020): 156-160.
Vecellio E, Schembri N, Manessis A, et al. "Data quality associated with handwritten laboratory test requests and autoverification failures". Health Inf Manag J 45(2016): 26-33.
Randell EW, Short G. "Autoverification process improvement by Six Sigma approach: clinical chemistry & immunoassay". Clin Biochem 89(2021): 3-9.
Levy AE, Persaud NS, Gough M, et al. "Reagent lot change management in clinical chemistry: a practical framework". Clin Chem Lab Med 58(2020): 1425-1431.
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