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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
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1437-4331
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Volume 57, Issue 9

Issues

Design and implementation of quality control plans that integrate moving average and internal quality control: incorporating the best of both worlds

Huub H. van Rossum
  • Corresponding author
  • Department of Laboratory Medicine, The Netherlands Cancer Institute, Amsterdam, The Netherlands
  • Huvaros, Amsterdam, The Netherlands, Phone: +31-20-5122756, Fax: +31-20-5122799
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Daan van den Broek
  • Department of Laboratory Medicine, The Netherlands Cancer Institute, Amsterdam, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2019-03-23 | DOI: https://doi.org/10.1515/cclm-2019-0027

Abstract

Background

New moving average quality control (MA QC) optimization methods have been developed and are available for laboratories. Having these methods will require a strategy to integrate MA QC and routine internal QC.

Methods

MA QC was considered only when the performance of the internal QC was limited. A flowchart was applied to determine, per test, whether MA QC should be considered. Next, MA QC was examined using the MA Generator (www.huvaros.com), and optimized MA QC procedures and corresponding MA validation charts were obtained. When a relevant systematic error was detectable within an average daily run, the MA QC was added to the QC plan. For further implementation of MA QC for continuous QC, MA QC management software was configured based on earlier proposed requirements. Also, protocols for the MA QC alarm work-up were designed to allow the detection of temporary assay failure based on previously described experiences.

Results

Based on the flowchart, 10 chemistry, two immunochemistry and six hematological tests were considered for MA QC. After obtaining optimal MA QC settings and the corresponding MA validation charts, the MA QC of albumin, bicarbonate, calcium, chloride, creatinine, glucose, magnesium, potassium, sodium, total protein, hematocrit, hemoglobin, MCH, MCHC, MCV and platelets were added to the QC plans.

Conclusions

The presented method allows the design and implementation of QC plans integrating MA QC for continuous QC when internal QC has limited performance.

Keywords: analytical quality control; average of normal (AoN); moving average (MA); quality assurance; quality control

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About the article

Received: 2019-01-08

Accepted: 2019-02-25

Published Online: 2019-03-23

Published in Print: 2019-08-27


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

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 57, Issue 9, Pages 1329–1338, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2019-0027.

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