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The Importance of Third Party Controls


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Find out how third party controls can help clinical laboratories identify analytical errors and meet ISO 15189 accreditation requirements.

Find out how third party controls can help clinical laboratories identify analytical errors and meet ISO 15189 accreditation requirements.

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  • 1. The Importance of Third Party Quality Controls Get an unbiased, independent assessment of analytical performance QUALITY CONTROL
  • 2. Quality Control Quality control refers to the process of detecting analytical errors within the laboratory to ensure both the reliability and accuracy of test results. Poor performance can result in misdiagnosis, delayed treatment, increased costs and may even be potentially life threatening for the patient.Without good quality control, how can you be confident the results you provide 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 Third Party Controls with an extended shelf life enable long term performance monitoring across multiple reagent batches Year One Year Two Year Three Instrument Manufacturer Reagent Batch 1 Batch 2 Batch 3 Instrument Manufacturer Control Lot 1 Lot 2 Lot 3 RandoxThird Party Controls Lot 1
  • 3. 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 and provide an unbiased, independent assessment of analytical performance. • Randox true third party controls are manufactured independently from our reagents and calibrators meaning they can even be used with Randox reagents on the RX series of analysers. Furthermore thousands of independent laboratories are used during the value assignment process with target values compared to reference methods to ensure accuracy and reliability. • With a shelf life of up to four years Randox controls enable long term QC monitoring and the detection of shifts upon change of reagent batch. They can even help laboratories save time and money due to fewer lot crossovers. •The availability of multi-analyte, multi-instrument controls from Randox allow laboratories to replace multiple instrument specific controls with a single control product. Many 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. • In some cases the same raw materials are used to manufacture both the controls and calibrators making the control less sensitive to performance changes. • Laboratories using an ‘in-kit’ control will receive a new lot of QC with each new batch of reagent meaning they are constantly changing lot number and do not have the benefit of long term QC monitoring. • Furthermore it is not uncommon for instrument and reagent manufacturers to assign their QC using only a limited number of results generated exclusively on their own instruments using their own reagents and calibrators. •This often results in perceived accuracy, unrealistic wide ranges and batch to batch variability. The use of non third party controls will ultimately lead to the release of incorrect patient results. Randox Third Party Controls Instrument/Reagent Manufacturers ControlsVS The Importance of Third Party Quality Controls
  • 4. The following 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. Detecting... instrument faults 1) The laboratory used the reagent manufacturer’s QC for all Bilirubin testing. The assay appeared to be working well, with QC results within range 2) They also ran Randox Acusera Assayed Chemistry Premium Plus control and the results reported were approximately 25% low to target 3) The laboratory contacted the Randox Technical Support 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 Conclusion Randox third party controls identified an instrument fault that in-kit controls from the reagent manufacturer failed to detect. The Importance of Third Party Controls in Helping to Detect Errors within the Laboratory A real life laboratory situation Quality Control
  • 5. Detecting... shifts after changing reagent batch Detecting... procedural errors 1) AlaboratoryusingRandoxAcuseraImmunoassayPremium 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 Randox Technical Support 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 Conclusion The Randox Immunoassay control detected a shift in results that the instrument manufacturer’s control did not. 1) A laboratory using 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 results were as expected 3) After reviewing the reagent kit insert,the Randox Technical Support 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 Conclusion The Randox Immunoassay control detected a procedural error that the reagent manufacturer’s control did not. The Importance of Third Party Quality Controls A real life laboratory situation A real life laboratory situation
  • 6. 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. The Clinical and Laboratory Standards Institute (CLSI) C24-A3, the Statistical Quality Control for Quantitative Measurement Procedures. Regulatory Requirements Reinforce the Need to Use Third Party Quality Controls The National Association of Testing Authorities,Australia (NATA) Supplemental Requirements for accreditation in the field of Medical testing. NATA CLSI “Controls independent of those produced by the manufacturer of the test or analyser should be used.” “…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.” Quality Control
  • 7. The Quality Council of India (QCI) Essential Standards for Registration of Medical Testing Laboratories in India, 3.5.2 Quality Assurance. The Laboratory Accreditation Scheme of Malaysia (5.6.1 Quality Control). “Medical laboratories shall perform internal quality control. Use of third party human matrix quality control is recommended for all analytes.” “The use of controls independent from those produced by the manufacturer of the test or analyser is preferable.” QCI LASM The Importance of Third Party Quality Controls
  • 8. Accurate target values 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 20,000 laboratory participants. Unrivalled stability 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 will meet and often exceed the stability claims quoted. Convenient and easy-to-use Many Randox controls are available in liquid format, eliminating variability due to reconstitution errors. 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. Highest quality material The Randox range of lyophilised controls contain no added preservatives or stabilisers which can cause interference problems. In addition to this, all controls for use with antibody based tests are made from 100% human serum providing a matrix similar to the patient sample. Quality Controls available • Chemistry • Immunoassay • Immunology/Proteins • Cardiac • Lipids • Diabetes • Urine Chemistry • Urinalysis •Toxicology •TDM •Tumour Markers • Maternal Screening • Coagulation • Blood Gas • Speciality/Research • Antioxidants Information correct at time of print. Randox Laboratories Limited is a company registered within Northern Ireland with company number N.I. 15738. VAT Registered Number: GB 151 6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information. Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom T +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E I LT324SEP13 Randox is yourTrustedThird Party QC Supplier The Acusera range of true third party controls is extensive covering over 350 routine and esoteric parameters. All controls are designed to help reduce the potential for bias by accurately and reliably identifying performance issues and potential weaknesses with a test system or reagent. Acusera 24•7 Live Online is a web based interlaboratory data management and peer group reporting package designed to compliment and support the Acusera range of control sera. Acusera 24•7 peer group data is uniquely updated every 24 hours providing users with the most up to date information. RIQAS -The world’s largest global EQA scheme • Blood Gas • Cardiac • Coagulation • Clinical Chemistry • Glycated Haemoglobin • Haematology • Human Urine • Immunoassay • Immunoassay Speciality 1 • Immunoassay Speciality 2 • Lipids • Liquid Cardiac • Maternal Screening • Serology (EBV) • Serology (HIV-Hepatitis) • Serology (Syphilis) • Serology (ToRCH) • Specific Proteins •Therapeutic Drugs • Urinalysis • UrineToxicology (HbA1c)