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Benefits, limitations and controversies on patient-based real-time quality control (PBRTQC) and the evidence behind the practice

  • Huub H. van Rossum EMAIL logo , Andreas Bietenbeck ORCID logo , Mark A. Cervinski , Alex Katayev , Tze Ping Loh and Tony C. Badrick
Published/Copyright: March 11, 2021
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 59 Issue 7

Abstract

Background

In recent years, there has been renewed interest in the “old” average of normals concept, now generally referred to as moving average quality control (MA QC) or patient-based real-time quality control (PBRTQC). However, there are some controversies regarding PBRTQC which this review aims to address while also indicating the current status of PBRTQC.

Content

This review gives the background of certain newly described optimization and validation methods. It also indicates how QC plans incorporating PBRTQC can be designed for greater effectiveness and/or (cost) efficiency. Furthermore, it discusses controversies regarding the complexity of obtaining PBRTQC settings, the replacement of iQC, and software functionality requirements. Finally, it presents evidence of the added value and practicability of PBRTQC.

Outlook

Recent developments in, and availability of, simulation methods to optimize and validate laboratory-specific PBRTQC procedures have enabled medical laboratories to implement PBRTQC in their daily practice. Furthermore, these methods have made it possible to demonstrate the practicability and added value of PBRTQC by means of two prospective “clinical” studies and other investigations. Although internal QC will remain an essential part of any QC plan, applying PBRTQC can now significantly improve its performance and (cost) efficiency.

Keywords: average of normals; moving average; patient-based real-time quality control (PBRTQC); quality assurance; quality control
Corresponding author: Huub H. van Rossum, The Netherlands Cancer Institute, Plesmanlaan 121, 1066CXAmsterdam, The Netherlands; and Huvaros, The Netherlands, Phone: +31 20 5122756, Fax: +31 20 5122799, E-mail:

Acknowledgments

Not applicable

  1. Research funding: None to declare

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: H.H. van Rossum is owner and director of www.huvaros.com that markets MA Generator.

  4. Informed consent: Not applicable.

  5. Ethical approval: Not applicable.

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Received: 2021-01-18
Accepted: 2021-02-26
Published Online: 2021-03-11
Published in Print: 2021-06-25

© 2021 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2021-0072
Keywords for this article
average of normals; moving average; patient-based real-time quality control (PBRTQC); quality assurance; quality control

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Machine learning and coagulation testing: the next big thing in hemostasis investigations?
  4. Reviews
  5. Updates on liquid biopsy: current trends and future perspectives for clinical application in solid tumors
  6. The underestimated issue of non-reproducible cardiac troponin I and T results: case series and systematic review of the literature
  7. Opinion Paper
  8. Benefits, limitations and controversies on patient-based real-time quality control (PBRTQC) and the evidence behind the practice
  9. Genetics and Molecular Diagnostics
  10. ctDNA from body fluids is an adequate source for EGFR biomarker testing in advanced lung adenocarcinoma
  11. General Clinical Chemistry and Laboratory Medicine
  12. Incidence, characteristics and outcomes among inpatient, outpatient and emergency department with reported high critical serum potassium values
  13. Clinical usefulness of drug-laboratory test interaction alerts: a multicentre survey
  14. Integrating quality assurance in autoimmunity: the changing face of the automated ANA IIF test
  15. Plasma thiol/disulphide homeostasis changes in patients with restless legs syndrome
  16. Reference Values and Biological Variations
  17. High-resolution pediatric reference intervals for 15 biochemical analytes described using fractional polynomials
  18. Continuous reference intervals for leukocyte telomere length in children: the method matters
  19. Hematology and Coagulation
  20. Using machine learning to identify clotted specimens in coagulation testing
  21. Cardiovascular Diseases
  22. Long term pronostic value of suPAR in chronic heart failure: reclassification of patients with low MAGGIC score
  23. Infectious Diseases
  24. Monocyte distribution width (MDW) parameter as a sepsis indicator in intensive care units
  25. A low level of CD16pos monocytes in SARS-CoV-2 infected patients is a marker of severity
  26. Thrombin generation in patients with COVID-19 with and without thromboprophylaxis
  27. Corrigendum
  28. Applying the concept of uncertainty to the sFlt-1/PlGF cut-offs for diagnosis and prognosis of preeclampsia
  29. Letters to the Editors
  30. Additional approaches for identifying non-reproducible cardiac troponin results
  31. Paediatric reference intervals for ionised calcium – a data mining approach
  32. A case of interference in testosterone, DHEA-S and progesterone measurements by second generation immunoassays
  33. Lack of cross-reactivity between anti-A IgG isoagglutinins and anti-SARS-CoV-2 IgG antibodies
  34. Artefactual bands on urine protein immunofixation gels
  35. A case of methaemoglobinaemia interference on the WDF channel on Sysmex XN-Series analysers
  36. Soluble fms-like tyrosine kinase-1: a potential early predictor of respiratory failure in COVID-19 patients
  37. Serendipitous detection of α1-antitrypsin deficiency: a single institution’s experience over a 32 month period
  38. The activated partial thromboplastin time may not reveal even severe fibrinogen deficiency
  39. Influence of C-reactive protein on thrombin generation assay
  40. Inappropriate extrapolations abound in fecal microbiota research
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