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Laboratory services: regaining and maintaining control

Graham R. Lee (Department of Clinical Biochemistry and Diagnostic Endocrinology, Mater Misericordiae University Hospital, Dublin, Ireland)
Maria C. Fitzgibbon (Department of Clinical Biochemistry and Diagnostic Endocrinology, Mater Misericordiae University Hospital, Dublin, Ireland)
Paula O'Shea (Department of Clinical Biochemistry, Saolta Hospital Group, Galway, Ireland)

International Journal of Health Care Quality Assurance

ISSN: 0952-6862

Article publication date: 13 June 2016

509

Abstract

Purpose

After implementing an internal quality control (IQC) programme, the purpose of this paper is to maintain the requisite analytical performance for clinical laboratory staff, thereby safeguarding patient test results for their intended medical purpose.

Design/methodology/approach

The authors address how quality can be maintained and if lost, how it can be regained. The methodology is based on the experience working in clinical laboratory diagnostics and is in accord with both international accreditation requirements and laboratory best practice guidelines.

Findings

Monitoring test performance usually involves both prospective and retrospective IQC data analysis. The authors present a number of different approaches together with software tools currently available and emerging, that permit performance monitoring at the level of the individual analyser, across analysers and laboratories (networks). The authors make recommendations on the appropriate response to IQC rule warnings, failures and metrics that indicate analytical control loss, that either precludes further analysis, or signifies deteriorating performance and eventual unsuitability. The authors provide guidance on systematic troubleshooting, to identify undesirable performance and consider risk assessment preventive measures and continuous quality improvement initiatives; e.g., material acceptance procedures, as tools to help regain and maintain analytical control and minimise potential for patient harm.

Practical implications

The authors provide a template for use by laboratory scientific personnel that ensures the optimal monitoring of analytical test performance and response when it changes undesirably.

Originality/value

The proposed template has been designed to meet the International Organisation for Standardisation for medical laboratories ISO15189:2012 requirements and therefore includes the use of External Quality Assessment and patient results data, as an adjunct to IQC data.

Keywords

Citation

Lee, G.R., Fitzgibbon, M.C. and O'Shea, P. (2016), "Laboratory services: regaining and maintaining control", International Journal of Health Care Quality Assurance, Vol. 29 No. 5, pp. 507-522. https://doi.org/10.1108/IJHCQA-08-2015-0098

Publisher

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Emerald Group Publishing Limited

Copyright © 2016, Emerald Group Publishing Limited

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