title: In control? IQC consensus and statutory regulation.
abstract: Purpose - Internal quality control (IQC) represents an essential risk management tool within the total testing pathway (TTP) that contributes to the overall objective of assuring the quality of results produced in medical laboratories. Controlling analytical phase quality alone requires significant expertise and input by scientifically trained staff. This effort has escalated exponentially following the publication of the International Organisation for Standardisation (ISO)15189:2012 requirements for quality and competence in medical laboratories. The reported inconsistency and diversity to IQC approaches in diagnostic laboratories is definitive evidence that international guidance in IQC programme design and implementation is long overdue. The paper aims to discuss these issues. Design/methodology/approach - Herein, the authors define, describe and critically examine the essential elements four stages of an IQC programme and suggest a template to inform both design and ease of implementation. For practical application, the authors have stratified the proposed methodology into four stages: staff education and training; IQC material; IQC targets; and IQC procedure, and provide recommendations that meet ISO15189:2012 requirements. Findings - These recommendations are informed by the published literature together with the collective experience working in clinical biochemistry and diagnostic endocrinology laboratories. The authors note that the laboratory staff's effort on IQC is a continuous process, driven by changes within each IQC stage, in response to risk analysis, maximising economic value or through professional leadership and central to IQC programme implementation and delivery. Practical implications - The authors offer a template that laboratories can use to inform the design and implementation of their IQC programme. Originality/value - The proposed IQC programme is user friendly, flexible and pragmatic with the potential to harmonise practice. The authors have provided a template to potentially harmonise IQC practice nationally. Given the central and critical role that IQC practice plays in ensuring the quality of patient results' importance, the authors contend that the time has come for international consensus and statutory regulation regarding the minimally acceptable criteria for its implementation, monitoring and review.
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: D064790:Clinical Laboratory Services / Q000458:organization & administration* / Q000592:standards; D006801:Humans; D007318:Inservice Training; D011361:Professional Competence; D011786:Quality Control; D012308:Risk Management
keywords: Process control; Process design; Quality improvement; Risk management; Six Sigma