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Verification of automated review, release and reporting of results with assessment of the risk of harm for patients: the procedure algorithm proposal for clinical laboratories

  • Marijana Miler ORCID logo EMAIL logo , Nora Nikolac Gabaj ORCID logo , Gordan Šimić , Adriana Unić , Lara Milevoj Kopčinović , Marija Božović , Anita Radman , Alen Vrtarić , Mario Štefanović and Ines Vukasović
Published/Copyright: December 30, 2024
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 6

Abstract

Objectives

Autoverification increases the efficiency of laboratories. Laboratories accredited according to ISO 15189:2022 need to validate their processes, including autoverification, and assess the associated risks to patient safety. The aim of this study was to propose a systematic verification algorithm for autoverification and to assess its potential risks.

Methods

The study was conducted using retrospective data from the Laboratory Information System (LIS). Seven laboratory medicine specialists participated. Autoverification rules were defined for analytes in serum, stool, urine and whole blood determined on Alinity ci (Abbott), Atellica 1500 (Siemens) and ABL90 FLEX (Radiometer). Criteria included internal quality control results, instrument flags, hemolysis/icteria/lipemia indices, median patient values, critical values, measurement ranges, delta checks, and reference values. Verification was performed step by step. Risk analysis was performed using Failure Modes and Effects Analysis and the Risk Priority Number (RPN) was calculated.

Results

During the study, 23,633 laboratory reports were generated, containing 246,579 test results for 167 biochemical tests. Of these, 198,879 (80.66 %) met the criteria for autoverification. For 2,057 results (0.83 %), the experts disagreed with the autoverification criteria (false negatives). Discrepancies were mainly associated to median and delta check values. Only 45 false positives (0.02 %) were identified, resulting in an RPN of 0 for all cases.

Conclusions

The autoverified and non-autoverified results showed high agreement with the expert opinions, with minimal disagreement (0.02 % and 0.83 %, respectively). The risk analysis showed that autoverification did not pose a significant risk to patient safety. This study, the first of its kind, provides step-by-step recommendations for implementing autoverification in laboratories.

Keywords: autoverification; criteria; ISO 15189:2022; risk analysis; verification
Corresponding author: Marijana Miler, PhD, Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, Vinogradska cesta 29, 10000, Zagreb, Croatia, E-mail:

Funding source: European Regional Development and Croatian Ministry of Science fund under the Operational Programme “Competitiveness and Cohesion 2014-2020”

Award Identifier / Grant number: KK.01. 1. 1.02.0014

  1. Research ethics: This study was conducted in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki). Ethical approval was not required as the data used were completely anonymized and based solely on test results. No personal information or clinical details of individual patients were collected or stored.

  2. Informed consent: Not applicable.

  3. Author contributions: All authors contributed significantly to this study. MM, NNG, AU, LMK, MB, AR, AV drafted the study design. MM, NNG and MŠ defined the criteria. GŠ provided the informatics solution and managed the data extraction from the Laboratory Information System (LIS). MM, NNG, AU, LMK, MB, AR, AV carried out the verification. MM and IV analyzed the data. MM and NNG drafted the original manuscript. All authors reviewed and approved the final manuscript and have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: The study was financially supported by the European Regional Development and Croatian Ministry of Science fund under the Operational Programme “Competitiveness and Cohesion 2014–2020” (grant KK.01. 1. 1.02.0014).

  7. Data availability: Most of the data generated and analyzed as part of this study are available in this published article (and its supplementary information files), and additional data sets are available upon reasonable request to the corresponding author.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-1164).

Received: 2024-10-04
Accepted: 2024-12-17
Published Online: 2024-12-30
Published in Print: 2025-05-26

© 2024 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-1164
Keywords for this article
autoverification; criteria; ISO 15189:2022; risk analysis; verification

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. The Friedewald formula strikes back
  4. Liquid biopsy in oncology: navigating technical hurdles and future transition for precision medicine
  5. The neglected issue of pyridoxal- 5′ phosphate
  6. Reviews
  7. Health literacy: a new challenge for laboratory medicine
  8. Clinical applications of circulating tumor cell detection: challenges and strategies
  9. Opinion Papers
  10. Pleural effusion as a sample matrix for laboratory analyses in cancer management: a perspective
  11. Interest of hair tests to discriminate a tail end of a doping regimen from a possible unpredictable source of a prohibited substance in case of challenging an anti-doping rule violation
  12. Perspectives
  13. Sigma Metrics misconceptions and limitations
  14. EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes
  15. General Clinical Chemistry and Laboratory Medicine
  16. Evaluation of current indirect methods for measuring LDL-cholesterol
  17. Verification of automated review, release and reporting of results with assessment of the risk of harm for patients: the procedure algorithm proposal for clinical laboratories
  18. Progranulin measurement with a new automated method: a step forward in the diagnostic approach to neurodegenerative disorders
  19. A comparative analysis of current С-peptide assays compared to a reference method: can we overcome inertia to standardization?
  20. Blood samples for ammonia analysis do not require transport to the laboratory on ice: a study of ammonia stability and cause of in vitro ammonia increase in samples from patients with hyperammonaemia
  21. A physio-chemical mathematical model of the effects of blood analysis delay on acid-base, metabolite and electrolyte status: evaluation in blood from critical care patients
  22. Evolution of autoimmune diagnostics over the past 10 years: lessons learned from the UK NEQAS external quality assessment EQA programs
  23. Comparison between monotest and traditional batch-based ELISA assays for therapeutic drug monitoring of infliximab and adalimumab levels and anti-drug antibodies
  24. Evaluation of pre-analytical factors impacting urine test strip and chemistry results
  25. Evaluation of AUTION EYE AI-4510 flow cell morphology analyzer for counting particles in urine
  26. Reference Values and Biological Variations
  27. Estimation of the allowable total error of the absolute CD34+ cell count by flow cytometry using data from UK NEQAS exercises 2004–2024
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  30. Tumor specific protein 70 targeted tumor cell isolation technology can improve the accuracy of cytopathological examination
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