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QC Constellation: a cutting-edge solution for risk and patient-based quality control in clinical laboratories

  • Hikmet Can Çubukçu ORCID logo EMAIL logo
Published/Copyright: May 31, 2024
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 62 Issue 11

Abstract

Objectives

Clinical laboratories face limitations in implementing advanced quality control (QC) methods with existing systems. This study aimed to develop a web-based application to addresses this gap, and improve QC practices.

Methods

QC Constellation, a web application built using Python 3.11, integrates various statistical QC modules. These include Levey-Jennings charts with Westgard rules, sigma-metric calculations, exponentially weighted moving average (EWMA) and cumulative sum (CUSUM) charts, and method decision charts. Additionally, it offers a risk-based QC section and a patient-based QC module aligning with modern QC practices. The codes and the web application links for QC Constellation were shared at https://github.com/hikmetc/QC_Constellation, and http://qcconstellation.com, respectively.

Results

Using synthetic data, QC Constellation demonstrated effective implementation of Levey-Jennings charts with user-friendly features like checkboxes for Westgard rules and customizable moving averages graphs. Sigma-metric calculations for hypothetical performance values of serum total cholesterol were successfully performed using allowable total error and maximum allowable measurement uncertainty goals, and displayed on method decision charts. The utility of the risk-based QC module was exemplified by assessing QC plans for serum total cholesterol, showcasing the application’s capability in calculating risk-based QC parameters including maximum unreliable final patient results, risk management index, and maximum run size and offering risk-based QC recommendations. Similarly, the patient-based QC and optimization modules were demonstrated using simulated sodium results.

Conclusions

In conclusion, QC Constellation emerges as a pivotal tool for laboratory professionals, streamlining the management of quality control and analytical performance monitoring, while enhancing patient safety through optimized QC processes.

Keywords: performance evaluation; quality control; risk-based quality control; patient-based quality control; risk management; sigma metric
Corresponding author: Hikmet Can Çubukçu, MD, EuSpLM, General Directorate of Health Services, Rare Diseases Department, Turkish Ministry of Health, Bilkent Yerleskesi, 6001. Cadde, Universiteler Mahallesi 06800, Çankaya/Ankara, Türkiye, E-mail:

Acknowledgments

I express my gratitude to Oğuzhan Zengi for sharing recent literature knowledge.

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: The author has accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: The author states no conflict of interest.

  5. Research funding: None declared.

  6. Data availability: The codes of the application were shared at https://github.com/hikmetc/QC_Constellation.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0156).

Received: 2024-01-31
Accepted: 2024-04-30
Published Online: 2024-05-31
Published in Print: 2024-10-28

© 2024 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-0156
Keywords for this article
performance evaluation; quality control; risk-based quality control; patient-based quality control; risk management; sigma metric

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Circulating tumor DNA measurement: a new pillar of medical oncology?
  4. Reviews
  5. Circulating tumor DNA: current implementation issues and future challenges for clinical utility
  6. Circulating tumor DNA methylation: a promising clinical tool for cancer diagnosis and management
  7. Opinion Papers
  8. The final part of the CRESS trilogy – how to evaluate the quality of stability studies
  9. The impact of physiological variations on personalized reference intervals and decision limits: an in-depth analysis
  10. Computational pathology: an evolving concept
  11. Perspectives
  12. Dynamic mirroring: unveiling the role of digital twins, artificial intelligence and synthetic data for personalized medicine in laboratory medicine
  13. General Clinical Chemistry and Laboratory Medicine
  14. Macroprolactin in mothers and their babies: what is its origin?
  15. The influence of undetected hemolysis on POCT potassium results in the emergency department
  16. Quality control in the Netherlands; todays practices and starting points for guidance and future research
  17. QC Constellation: a cutting-edge solution for risk and patient-based quality control in clinical laboratories
  18. OILVEQ: an Italian external quality control scheme for cannabinoids analysis in galenic preparations of cannabis oil
  19. Using Bland-Altman plot-based harmonization algorithm to optimize the harmonization for immunoassays
  20. Comparison of a two-step Tempus600 hub solution single-tube vs. container-based, one-step pneumatic transport system
  21. Evaluating the HYDRASHIFT 2/4 Daratumumab assay: a powerful approach to assess treatment response in multiple myeloma
  22. Insight into the status of plasma renin and aldosterone measurement: findings from 526 clinical laboratories in China
  23. Reference Values and Biological Variations
  24. Reference values for plasma and urine trace elements in a Swiss population-based cohort
  25. Stimulating thyrotropin receptor antibodies in early pregnancy
  26. Within- and between-subject biological variation estimates for the enumeration of lymphocyte deep immunophenotyping and monocyte subsets
  27. Diurnal and day-to-day biological variation of salivary cortisol and cortisone
  28. Web-accessible critical limits and critical values for urgent clinician notification
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  30. Thyroglobulin measurement is the most powerful outcome predictor in differentiated thyroid cancer: a decision tree analysis in a European multicenter series
  31. Cardiovascular Diseases
  32. Interaction of heparin with human cardiac troponin complex and its influence on the immunodetection of troponins in human blood samples
  33. Diagnostic performance of a point of care high-sensitivity cardiac troponin I assay and single measurement evaluation to rule out and rule in acute coronary syndrome
  34. Corrigendum
  35. Reference intervals of 24 trace elements in blood, plasma and erythrocytes for the Slovenian adult population
  36. Letters to the Editor
  37. Disturbances of calcium, magnesium, and phosphate homeostasis: incidence, probable causes, and outcome
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