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Research ArticleSpecial Report

Patient-Based Real-Time Quality Control: Review and Recommendations

Tony Badrick, Andreas Bietenbeck, Mark A. Cervinski, Alex Katayev, Huub H. van Rossum, Tze Ping Loh
DOI: 10.1373/clinchem.2019.305482 Published July 2019
Tony Badrick
RCPA Quality Assurance Programs, St. Leonards, Sydney, Australia;
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  • For correspondence: tony.badrick@rcpaqap.com.au
Andreas Bietenbeck
Institut für Klinische Chemie und Pathobiochemie Klinikum, Münich, Germany;
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Mark A. Cervinski
Dartmouth-Hitchcock Medical Center, Lebanon, NH; Geisel School of Medicine at Dartmouth, Hanover, NH;
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Alex Katayev
Laboratory Corporation of America Holdings, Elon, NC;
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Huub H. van Rossum
The Netherlands Cancer Institute, Amsterdam, the Netherlands; Huvaros, Amsterdam, the Netherlands;
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Tze Ping Loh
National University Hospital, Singapore.
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Abstract

For many years the concept of patient-based quality control (QC) has been discussed and implemented in hematology laboratories; however, the techniques have not been widely implemented in clinical chemistry. This is mainly because of the complexity of this form of QC, as it needs to be optimized for each population and often for each analyte. However, the clear advantages of this form of QC, together with the ongoing realization of the shortcomings of “conventional” QC, have driven a need to provide guidance to laboratories to assist in deploying patient-based QC. This overview describes the components of a patient-based QC system (calculation algorithm, block size, truncation limits, control limits) and the relationship of these to the analyte being controlled. We also discuss the need for patient-based QC system optimization using patient data from the individual testing laboratory to reliably detect systematic errors while ensuring that there are few false alarms. The term patient-based real-time quality control covers many activities that use data from patient samples to detect analytical errors. These activities include the monitoring of patient population parameters such as the mean or median analyte value or using single within-patient changes such as the delta check. In this report, we will restrict the discussion to population-based parameters. This overview is intended to serve as a guide for the implementation of a patient-based QC system. The report does not cover the clinical evaluation of the population.

  • Received for publication March 31, 2019.
  • Accepted for publication May 23, 2019.
  • © 2019 American Association for Clinical Chemistry
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Clinical Chemistry: 65 (8)
Vol. 65, Issue 8
August 2019
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Patient-Based Real-Time Quality Control: Review and Recommendations
Tony Badrick, Andreas Bietenbeck, Mark A. Cervinski, Alex Katayev, Huub H. van Rossum, Tze Ping Loh
Clinical Chemistry Aug 2019, 65 (8) 962-971; DOI: 10.1373/clinchem.2019.305482
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Patient-Based Real-Time Quality Control: Review and Recommendations
Tony Badrick, Andreas Bietenbeck, Mark A. Cervinski, Alex Katayev, Huub H. van Rossum, Tze Ping Loh
Clinical Chemistry Aug 2019, 65 (8) 962-971; DOI: 10.1373/clinchem.2019.305482

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