Importance of Third Party Quality Controls
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Third party quality controls are important to ensure accurate patient test results. They provide an independent assessment of analytical performance compared to controls from instrument or reagent manufacturers. The document describes several examples where Randox third party controls detected errors that dedicated manufacturer controls failed to identify, including instrument faults, procedural errors, and shifts in results between reagent batches. Regulatory bodies recommend using third party controls over manufacturer controls to independently monitor testing quality.
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Importance of Third Party Quality Controls
- 1. Importance of Third Party Quality Controls QUALITY CONTROL Complete QC solutions for results you can trust
- 2. In the clinical laboratory Quality Control (QC) refers to the process of detecting analytical errors to ensure both the reliability and accuracy of patient test results. Poor performance can result in misdiagnosis, delayed/inappropriate treatment, increased costs and may even be potentially life threatening for the patient.Without a good quality control system, how can you be confident the results you release are accurate? ‘The purpose of quality control is to monitor the analytical quality of a procedure, detect changes and eliminate reporting results with medically important errors’ 1 1 Westgard JO, Barry PL. Cost-Effective Quality Control: Managing the Quality and Productivity of Analytical Processes Quality Control There are three types of Quality Control material: 1. Instrument, kit, or method manufacturer supplied quality control (Dedicated/Dependent Controls) 2. Independent manufacturers of quality controls (Third Party Controls) 3. Independently manufactured controls intended for use with a specific instrument (Semi-dependent Controls) qual-ity con-trol Noun A system of maintaining standards in manufactured products by testing a sample of the output against the specification. (Oxford Dictionary; Oxford Universities Press 2013) 1
- 3. VSMany instrument and reagent manufacturers provide dedicated quality controls for use with their own reagents and analysers. These controls are not as effective as third party controls and often mask a multitude of weaknesses, ultimately leading to the release of incorrect patient results. • Often the same raw materials are used to manufacture the controls and calibrators making the control less sensitive to performance changes. • Laboratories using reagent dedicated controls will receive a new lot of QC with each new batch of reagent, meaning they are frequently changing lot number and do not benefit from long term QC monitoring. •Value assignment is frequently based on a limited number of results generated exclusively using the manufacturer’s own instrument, reagent and calibrator resulting in perceived accuracy. • In many cases, dedicated controls will not cover the patient reportable range, preventing the assessment of performance at key decision levels. Randox Third Party Controls Instrument Dependent Controls Third Party is the term used to describe a control that has not been designed or optimised for use with a specific test or system. As such, they mirror the performance of patient samples providing an unbiased, independent assessment of analytical performance. • Randox true third party controls are manufactured independently from our reagents and calibrators, therefore they can even be used with Randox reagents on the RX series of analysers. • Our unique value assignment process employs thousands of independent laboratories ensuring statistically valid targets are available for multiple instruments and methods. • With a shelf life of up to four years, laboratories can ensure continuity of lot supply whilst enabling long term QC monitoring. •The availability of multi-analyte, multi-instrument controls will reduce costs and preparation time, consolidating multiple instrument specific controls into a single control product. 2
- 4. Helping to Detect Errors within the Laboratory The following real life case studies highlight the importance of third party controls and how they can be used to help identify instrument, reagent and procedural errors which, if undetected, could lead to the reporting of incorrect patient results! 1) The laboratory used the reagent manufacturer’s QC for all Bilirubin testing. The assay appeared to be performing well, with QC results within range. 2) They also ran the Randox Acusera Assayed Chemistry Premium Plus Control and the results reported were approximately 25% lower than the target. 3) The laboratory contacted the RandoxTechnical Services team, who provided them with some EQA samples. 4) As suspected, results for these samples were 25% lower than expected. 5) Further investigations confirmed the low results were due to an instrument fault. Instrument Faults SUMMARY RandoxThird Party Controls identified an instrument fault that the dedicated controls from the reagent manufacturer failed to detect. 3
- 5. SUMMARY The Randox Immunoassay Control detected a procedural error that the reagent manufacturer’s control did not. 1) A laboratory using the Randox Acusera Immunoassay Premium Plus Control reported their QC results for Thyroglobulin were four times higher on their main analyser compared to other systems. 2) They ran the instrument manufacturer’s control alongside the Acusera control but it did not show the same problem. 3) After reviewing EQA data, the RandoxTechnical Services team confirmed there was a significant difference in results compared to other instruments. 4) The customer contacted their instrument manufacturer, who advised of a positive bias with several batches of reagent. 1) A laboratory using the Randox Immunoassay Premium Plus Control reported their QC results for SHBG were much higher than the target value provided. 2) They also ran the reagent manufacturer’s control and confirmed that results were within the ranges supplied. 3) After reviewing the reagent kit insert, the Randox Technical Services team noted that their instrument automatically dilutes patient samples but not controls. 4) The customer was unaware of this and had not been diluting the controls. Good laboratory practice is to run quality control materials the same way as a patient sample. Procedural Errors Shifts After Changing Reagent Batch SUMMARY The Randox Immunoassay Control detected a shift in results that the instrument dedicated control did not. 4
- 6. “Controls independent of those produced by the manufacturer of the test or analyser should be used.” Regulatory Requirements Reinforce the Need to use Third Party Controls Many regulatory bodies and standards from around the world highly recommend the use of true third party controls over those of the instrument or reagent manufacturer. NATA AS 4633 (ISO 15189). Supplemental Requirements for accreditation in the field of Medical testing. “…quality control materials should be different from the calibrator materials to ensure that the QC procedure provides an independent assessment of the measurement procedure’s performance in its entirety, including the procedure for calibration of the measurement.” CLSI CLSI C24-A3 Statistical Quality Control for Quantitative Measurement Procedures. Principles and Definitions;Approved Guideline – Third Edition, 6.2.1. “Medical laboratories shall perform internal quality control. Use of third party human matrix quality control is recommended for all analytes.” QCI Essential Standards for Registration of Medical Testing Laboratories in India, 3.5.2 Quality Assurance. “Use of third party human matrix controls independent of those produced by the manufacturer of the test or analyser should be used” DAC Dubai Accreditation Requirements for Medical Field ofTesting DAC-REQ-10 “Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer” ISO 15189 5.6.2.2 ISO 15189:2012 Medical Laboratories - Requirements for quality and competence 5
- 7. Highest Quality Material Randox controls are the most commutable available providing a matrix that reacts to the examining system in the same manner as a patient sample. Our lyophilised controls contain no added preservatives or stabilisers which can cause interference. Acusera Third Party Controls The Acusera range of true third party controls is extensive, covering over 390 routine and esoteric parameters. All controls are designed to deliver unbiased performance assessment with any instrument or method. Randox controls have the most accurately assigned target values and ranges on the market. This is made possible through access to a unique database of over 31,000 laboratory participants. Accurate Target Values Consolidation With Randox multi-analyte QC, you can dramatically reduce the number of controls used in your laboratory and save money by replacing multiple instrument specific controls with a single multi-analyser product. Randox lyophilised controls have a shelf life of up to four years enabling long term QC monitoring. The extended working stability of Acusera controls means they meet and often exceed the stability claims quoted. Unrivalled Stability 6
- 8. Randox Laboratories Ltd, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom +44 (0) 28 9442 2413 +44 (0) 28 9445 2912 marketing@randox.com randoxqc.com Information correct at time of print. Randox Laboratories Ltd is a subsidiary of Randox Holdings Limited a company registered within Northern Ireland with company number N.I. 614690. VAT Registered Number: GB 151 6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information. Products may be for Research Use Only and not for use in diagnostic procedures in the USA. QUALITY CONTROL find out more LT324JUN15 Designed for use with the Acusera range of third party controls, the Acusera 24•7 software will help laboratories monitor and interpret their QC data. Access to an impressive range of features, including interactive charts and real-time peer group data generated from our extensive database of laboratory participants, ensures Acusera 24•7 is the most comprehensive package available. Online QC software with real-time peer group statistics Comprising almost 360 routine and esoteric parameters in 24 comprehensive and flexible EQA programmes, RIQAS is designed to cover all areas of clinical testing. Each programme benefits from a wide range of concentrations, frequent reporting and comprehensive yet user-friendly reports. The largest global EQA scheme with over 31,000 lab participants With more than 390 parameters available across the range, and multiple parameters often present in a single control vial, labs can significantly reduce costs and consolidate without compromising on quality. As true third party controls, unbiased performance assessment with any instrument or method is guaranteed. True third party controls offering complete test menu consolidation