title: Laboratory services: regaining and maintaining control.
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.
authors.affiliation: Department of Clinical Biochemistry and Diagnostic Endocrinology, Mater Misericordiae University Hospital, Dublin, Ireland.
authors.forename: Graham R
authors.initials: GR
authors.lastname: Lee
authors.affiliation: Department of Clinical Biochemistry and Diagnostic Endocrinology, Mater Misericordiae University Hospital, Dublin, Ireland.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Fitzgibbon
authors.affiliation: Department of Clinical Biochemistry, Saolta Hospital Group, Galway, Ireland.
authors.forename: Paula
authors.initials: P
authors.lastname: O'Shea
mesh_terms: D000068:Accreditation; D064790:Clinical Laboratory Services / Q000458:organization & administration* / Q000592:standards; D006801:Humans; D011340:Problem Solving; D011361:Professional Competence; D011786:Quality Control; D012984:Software
keywords: Quality measures; Quality programmes; Risk management; Root cause analysis; Total quality management