Laboratory services: regaining and maintaining control
International Journal of Health Care Quality Assurance
ISSN: 0952-6862
Article publication date: 13 June 2016
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
:Emerald Group Publishing Limited
Copyright © 2016, Emerald Group Publishing Limited