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WORKGROUP 3 - INTERNATIONAL ASPECTS

This document by Dr. David G. Bullock discusses the importance of international External Quality Assessment (EQA) in clinical chemistry. It highlights methods to promote EQA in various regions, optimize the use of EQA for low-volume tests, and standardize practices through robust international networks. The report also examines the advantages, such as increased participant numbers and data validity, and challenges, including logistical issues and regulatory barriers that impact specimen transport and international collaboration. Recommendations aim to enhance EQA's effectiveness globally.

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WORKGROUP 3 - INTERNATIONAL ASPECTS

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  1. WORKGROUP 3 -INTERNATIONAL ASPECTS February 2002 Dr David G Bullock Director, Wolfson EQA Laboratory Organiser, UK NEQAS for Clinical Chemistry International Relations Director, UK NEQAS Executive Wolfson EQA Laboratory Queen Elizabeth Medical Centre Birmingham B15 2UE U K

  2. HOW CAN INTERNATIONAL EQA HELP? • promotion of EQA in countries or regions • increase utilisation of EQA for low volume tests • standardisation projects • establishing networks of reference laboratories • regional EQA where national schemes would be too small

  3. ADVANTAGES & DISADVANTAGES • Advantages: • larger number of participants • greater validity of data • affordability of special studies • aggregation of data on methods • IVD industry is global • international comparability • Disadvantages: • little participant influence on design • practical problems with specimen transport • slow turnaround

  4. SUBGROUP TOPICS • 3-1 Difficulties & barriers to be overcome • 3-2 Transport issues and international peer groups • 3-3 Definitions & procedures for international cooperation • 3-4 Orphan/low volume tests and criteria for international programs • 3-5 Conducting PT/EQA

  5. 3-1 Austin Demby [Louise Barden] • What difficulties are there in providing relevant EQA samples across international or intercontinental boundaries? • [language] • transport logistics • time and temperature • customs classification - what are EQA specimens? • tariff barriers

  6. What countries/regions have regulations creating non-tariff barriers inhibiting international cooperation, and how can they be removed? • laboratory licensing systems • accreditation requirements • national protectionism • [sub-group experience]

  7. 3-2 Carlyn Collins [Sue Empson] • What transport issues influence intercontinental use of EQA, and how can they be resolved? • time and temperature • classification of EQA specimens • UN, IATA, postal services • infectious and non-infectious materials

  8. Can international peer groups of EQAS be defined, and how? • EQA: • scheme purpose (education, licensing, method assessment) • scheme design (specimens, target values) • methods: • classification (instrument, reagent, calibrant) • coding

  9. 3-3 Roongrasamee Soisangwan [Vivienne James] • What is needed to allow EQA information to be exchanged comparably internationally? • data compatibility • data processing • report formats • scoring systems • compatibility with national schemes and needs

  10. What procedures (eg meetings) can facilitate international cooperation between EQAS? • WHO • International EQASs • workshops and training • IFCC CAQ • European experience • EU BCR, EQALM

  11. 3-4 Gary Myers [Chantal Maurice] • What processes facilitate EQA for 'orphan'/low volume assays, and what new processes are needed? • supra-national infrastructure (ERNDIM, European networks) • cooperation between national providers • specimen exchange systems • how can we get round the disadvantages? • slowturnaround, less communication, unresponsive, [language]

  12. What criteria should be used internationally for selection and provision of EQAS? • customer-dependent! • what are the obectives of participating? • fitness for purpose • value for money • cheapest not necessarily the most appropriate • [logistics] • [language]

  13. 3-5 Harry Hannon [Devery Howerton] What investigations (eg TB smears) are best assessed by reanalysis of clinical specimens than by sample distribution? • distribution EQA doesn't match routine incidence (too high) • re-screening is useful as QA/QC - has it a role in EQA? • is audit of practice (eg cytogenetics) better than distribution EQA? • can this include pre- and post-analytical performance?

  14. How would costs compare with conventional EQA, and what practical concerns (eg sampling, re-screening quality, logisitics) are there? • ethics and consent for use of patients' material • numbers/proportion to be re-screened • selection of re-screening site • transport of specimens • potential for identification etc errors

  15. INTENDED OUTCOMES • conclusions and recommendations to facilitate: • promotion of EQA in countries or regions • increase utilisation of EQA for low volume tests • standardisation projects • establishing networks of reference laboratories • regional EQA where national schemes would be too small

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