EDUCATIONAL GUIDE ISO 15189:2012 Accreditation Guide QUALITY CONTROL

ISO 15189:2012 Accreditation Guide Approximately 70% of clinical decisions are based on laboratory test results. Poor laboratory quality can result in unreliable test results ultimately leading to misdiagnosis, inappropriate treatment and may even impact the overall quality of life for the patient. The importance of quality medical services is recognised globally with several bodies existing internationally including ISO (International Organisation for Standardisation) who have developed a set of guidelines and quality systems to ensure reliable test results - ISO 15189:2012. This guide will...

1. First vs. Third Party Controls Quality Control products that have been developed and manufactured by the instrument/reagent manufacturer are considered First Party Controls and as such they are referred to as instrument dependent controls. These controls have generally been optimised for use with the manufacturers test system. Whilst this may appear to be beneficial using such First Party Controls will often mask a multitude of weaknesses and consequently are believed to lead to perceived accuracy and a biased assessment of performance. Therefore we can conclude that employing First Party...

3. Clinically Relevant Levels In addition to features such as third party and commutability, you should also consider whether the quality controls you are using contain analytes at clinically relevant levels. Karkalousos and Evangelopoulos (2011) define clinically relevant levels as levels which are used to “check the performance of laboratory methods across the measuring range”. For example, when measuring Troponin T the cut off value is 14 ng/l. Any patients who present to the hospital with a concentration higher than 14 ng/l in their blood is said to have had a cardiac event. Test results...

5. EQA (External Quality Assessment) Peer groups are also a key feature of EQA/PT schemes. These schemes will enable you to objectively review the quality of the results the laboratory produces and demonstrate competency in medical diagnostics. EQA/PT, when implemented correctly, exposes unexpected areas of underperformance, allowing you to identify any potential sources of error. The results measured are then compared against peers from other laboratories on regional, national or international levels. ISO 15189:2012 recommends that, as with IQC, EQA/PT schemes “should provide clinically relevant...

ACUSERA True third party quality controls As a world leading manufacturer of multi-analyte true third party controls, thousands of laboratories rely on Randox to accurately assess test system performance and ultimately empower them with the confidence required to release patient test results. With more than 390 analytes available, the number of individual controls required to cover your test menu is significantly reduced while simultaneously reducing costs, time and storage space. A choice of formats is available, including liquid or lyophilised, which ensures flexibility and suitability for...

ACUSERA 24•7 Interlaboratory Data Management Designed for use with the Acusera range of third party controls, the Acusera 24•7 software helps laboratories monitor and interpret their QC data. Access to an impressive range of features, including interactive charts, the automatic calculation of Measurement Uncertainty & Sigma Metrics and live peer group data generated from our extensive database of laboratory participants, ensures Acusera 24•7 is the most comprehensive package available. • Advanced statistical analysis with automatic calculation of performance metrics including; Sigma, UM, TE &...

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