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Clinical and Forensic Toxicology Proficiency Testing (EQA) Catalogue 2011/2012 Contents

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Clinical and Forensic Toxicology Proficiency Testing (EQA) Catalogue 2011/2012 Contents Clinical and forensic toxicology proficiency testing (EQA) catalogue 2011/2012 Contents Introduction • Promoting excellence through 3 proficiency testing • Aim of proficiency testing 3 • Quality standards 3 • Benefits of proficiency testing 4 • Who should participate in 4 proficiency testing schemes? • Who participates in LGC Standards 4 proficiency testing schemes? • Why choose LGC Standards as 4 your proficiency testing provider? • Why do I need proficiency testing? 4 • PT/EQA schemes for clinical and 5 forensic toxicology • Benefits of participation in 5 HEATHCONTROL PT/EQA schemes Clinical and forensic PT schemes • HEATHCONTROL – Therapeutic 6 Drug Monitoring (TDM) • HEATHCONTROL – Toxicology (TOX) 8 • HEATHCONTROL – Drugs of Abuse 9 in Urine (DAU) • HEATHCONTROL – Drugs in Oral 10 Fluid (DOF) • QUARTZ – Forensic blood 11 toxicology scheme • FORENSICS PT trial scheme 12 • Confidentiality 13 • Reports 13 • Other PT services 13 • Product development 13 • Reference materials 14 • Summary 14 Tel: +44 (0)161 762 2500 Fax: +44 (0)161 762 2501 Introduction LGC Standards Aim of proficiency testing Promoting excellence through Proficiency testing is defined in ISO/IEC 17043 proficiency testing as the evaluation of participant performance LGC Standards is an accredited international against pre-established criteria by means of provider of proficiency testing (PT) services interlaboratory comparisons. The terms “External also known as External Quality Assessment Quality Assessment or EQA” are often used for (EQA). We have over twenty five years proficiency testing in the medical/clinical area. experience in all aspects of providing PT services LGC Standards Proficiency Testing provides to laboratories undertaking clinical, chemical, a wide range of schemes designed to improve microbiological, and physical measurements. the quality of analysis in those sectors covered. LGC Standards operates 39 proficiency testing The schemes involve the regular distribution schemes serving more than 7,000 laboratories. of test materials in order for participants to test We produce in excess of 100,000 test materials for defined parameters, and to have their results which are distributed to over 140 countries statistically analysed. Participation provides worldwide. laboratories with a means of assessing the accuracy and comparability of their results We offer an unprecedented breadth of clinical, with peer laboratories over time. chemical, microbiological and physical testing schemes across a wide range of industries When performed within the context of a including clinical and forensic, pharmaceutical comprehensive quality assurance programme, and phytochemical sectors, meat, dairy and other proficiency testing is an independent means food sectors, water, soil and other environmental of assuring the quality of test and calibration sectors, brewing, distilling, malting, sugar and results, as described in ISO/IEC 17025 and other beverage sectors, cosmetics, toys and ISO 15189. other consumer safety sectors. Quality standards In addition to the variety of schemes offered, LGC Standards Proficiency Testing is committed LGC Standards can also provide managed to continual improvement in quality and solutions for in-house proficiency testing providers efficiency through procedures based upon and training for participants and their customers. quality assurance. This commitment is demonstrated through certification to ISO 9001 for all its activities and accreditation to ISO/IEC 17043 for the operation, management and design of proficiency testing schemes. LGC Standards Proficiency Testing is accredited by the United Kingdom Accreditation Service (UKAS, certificate number: 0001). Clinical schemes are currently accredited to the UK Clinical Pathology Accreditation (CPA) guidelines reference number 028/0054, 0028/0055, 028/0060, 028/0315. A copy of our current scope of accreditation is available on our website: www.lgcpt.com Email: [email protected] Website: www.lgcpt.com 3 Introduction Benefits of proficiency testing Who participates in LGC Standards proficiency testing schemes? Proficiency testing is an essential laboratory tool as it demonstrates a laboratory’s commitment LGC Standards exports to laboratories in over to good performance and enables participants 140 countries world-wide and our customer to confirm their ability to perform tests base ranges from single small enterprises competently; essential in the laboratory to inspection organisations of global repute. accreditation process. Our customers include hospitals and clinics, pharmaceuticals companies, government Participation in proficiency testing will: agencies, major international food manufacturers, • Enable participants to measure their research organisations, commercial and performance against others. contract laboratories. At present we have over • Give an early indication of potential problems 7,000 participants across the 39 schemes or training requirements. currently in operation. • Encourage good performance and reinforce LGC Standards manages a number of bespoke an interest in quality assurance. schemes for multi-national companies to meet • Demonstrate an ability to comply with their particular requirements. These special international regulations. schemes cover up to 200 laboratories. • Provide a valuable source of information. • Provide the means to measure consistency Why choose LGC Standards as your across a group of laboratories. proficiency testing provider? Who should participate in proficiency • Access to a wide range of schemes from testing schemes? a single supplier. • Rapid turnaround of results. Anyone who needs to independently demonstrate • Access to expert support and advice. the quality of their analytical results should • Local representation and support. participate in PT/EQA schemes - because quality of results relates directly to quality of product, Why do I need proficiency testing? reputation in the market and, ultimately, brand Accreditation bodies strongly recommend value. Whether operating in the clinical, forensic, that laboratories participate in appropriate food, pharmaceutical, beverages, environmental PT schemes as they are the only quality tool monitoring or other sectors, many regulators which can assess the whole quality system. view PT schemes as an essential part of quality PT is a truly independent measure of laboratory monitoring and many laboratories link PT performance and anonymously compares results to key performance indicators in the performance with peer laboratories. It allows quality assurance process. the laboratory to compare and contrast the performance of analytical methods and can assist in the validation of new methods. Participation in a PT scheme is educational and can be used as a tool for staff training, allowing laboratories to learn from both positive and negative performance. 4 Tel: +44 (0)161 762 2500 Fax: +44 (0)161 762 2501 Introduction PT/EQA schemes for clinical Benefits of participation in HEATHCONTROL and forensic toxicology PT/EQA schemes LGC Standards, recently acquired Cardiff HEATHCONTROL is a respected name in the Bioanalytical Services Ltd and now operates field of EQA with over 450 participants in more the range of HEATHCONTROL (EQA) schemes than 36 countries. for laboratories and screening clinics covering: By participating in the HEATHCONTROL • Therapeutic Drug Monitoring (TDM). schemes each participant gains the benefits • Toxicology (TOX). of a global proficiency testing scheme: • Drugs of Abuse in Urine (DAU). • The schemes are a truly independent • Drugs in Oral Fluid (DOF). assessment of measurement quality, which The definitive aim of PT/EQA schemes in a enables laboratories to demonstrate their clinical setting is improvement in analytical competence and compliance with respect performance in support of improved patient care. to regulatory standards. • Performance assessments obtained in the schemes are recognised as a demonstration of laboratory quality by a range of ‘third parties’, such as, customers, regulators and accreditation bodies. • The comprehensive scheme reports provide invaluable feedback on laboratory performance and are widely used as a training tool for laboratory personnel. • Performance assessment by method provides a mechanism for laboratories to compare their measurements with others using similar techniques and assists in the evaluation and development of methods and instrumentation. • Wide variety of analytes from one supplier for all your needs. • Significant numbers of participants worldwide means statistically robust results. Email: [email protected] Website: www.lgcpt.com 5 HEATHCONTROL – Therapeutic Drug There are many factors which influence an Monitoring (TDM) individual’s serum drug levels, these include but are not restricted to the age, sex, and weight of The Therapeutic Drug Monitoring (TDM) the patient; the route of administration of the scheme is designed to provide an independent drug; the drug’s absorption rate, excretion rate, performance assessment for laboratories delivery rate, and dosage; other medications the PT schemes and clinics who are involved in the routine patient is taking; pregnancy, temporary illness, quantification of therapeutic drugs in serum. Clinical and Forensic infection, emotional and physical stress, The TDM scheme is fully accredited in the U.K. trauma, and surgery; the patient’s compliance by Clinical Pathology Accreditation (CPA). regarding the drug treatment regimen; and the TDM is the measurement of specific
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