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Worldwide Infrastructure for Facilitating Traceability and Comparability of Chemical Measurements

Bureau International des Poids et Mesures. Worldwide Infrastructure for Facilitating Traceability and Comparability of Chemical Measurements Robert Wielgosz. A Worldwide Infrastructure. International activities MRA CCQM BIPM Key Comparison Database BIPM-NIST collaboration JCTLM and WHO

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Worldwide Infrastructure for Facilitating Traceability and Comparability of Chemical Measurements

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  1. Bureau International des Poids et Mesures Worldwide Infrastructure for Facilitating Traceability and Comparability of Chemical Measurements Robert Wielgosz

  2. A Worldwide Infrastructure • International activities • MRA • CCQM • BIPM Key Comparison Database • BIPM-NIST collaboration • JCTLM and WHO • National activities • Example 1: PTB, Germany • Example 2: LGC, UK • Conclusions • Designation of laboratories • Benefits of MRA participation

  3. International activities • MRA • Signed October 1999 • October 2002 • 42 member states of the Metre Convention • 7 Associates of the CGPM • 2 International Organizations • Growing number of designated institutes • www.bipm.org

  4. Objectives of the MRA are to: • establish the degree of equivalence of measurement • standards maintained by NMIs; • provide for the mutual recognition of calibration and • measurement certificates issued by NMIs; thereby to • provide governments and other parties with a secure • technical foundation for wider agreements related to • international trade, commerce and regulatory affairs

  5. BIPM KCDB: Appendix B

  6. BIPM KCDB: Appendix C

  7. Published CMCs by Chemical Category 2137 CMCs in Chemistry currently published

  8. WG on Gas Analysis WG on Inorganic Analysis Chairman: Dr E de Leer ( NMi) Chairman: Dr M Sargent (LGC) WG on Bioanalysis WG on Surface Analysis ad hoc Chairpersons: Chairman: Dr M Seah (NPL) Dr G Gilliland (NIST) Dr H Parkes (LGC) CCQM Organizational Structure CCQM President: Dr R Kaarls (CIPM) Executive Secretary: Dr R I Wielgosz (BIPM) WG on Key Comparisons Chairman: Dr H Semerjian (NIST) WG on Organic Analysis WG on Electrochemical Analysis Chairman: Dr W E May (NIST) Chairman: Dr M Mariassy (SMU)

  9. CCQM Organic Analysis Working Group

  10. CCQM Gas Analysis Working Group

  11. National and international networks for atmospheric ozone measurements • NIST-EPA Standard Reference Photometer (SRP) provides a mechanism for worldwide traceability of ozone measurements • US ambient O3 measurements under EPA regulations • an increasing number of worldwide national metrology labs maintain SRPs Joint NIST-BIPM programme to maintain the comparability of the worldwide network of ozone reference standards

  12. CCQM-P28 Ozone ambient level NIST Standard Reference Photometer (SRP) Network National Institute of Standards and Technology

  13. National capabilities for ozone reference standards CCQM-28 Questionnaire NMI or designated Laboratory = 13 Nominated but not yet designated = 9 Countries with activities, nomination expected = 10

  14. Ozone reference standard comparison facilities at the BIPM SRPs maintained by the BIPM SRP 27 SRP 28 SRP 19 (PTB)

  15. NIST (SRP 0) and BIPM (SRP 27 and 28) Comparison

  16. JOINT COMMITTEE on TRACEABILITYin LABORATORY MEDICINE (JCTLM)andMemorandum of Understanding between theWHO and the CIPM

  17. Mission Statement • “The aim of the Joint Committee is to support world-wide comparability, reliability and equivalence of measurement results in Laboratory Medicine, for the purpose of improving health care, by: • promoting the concept of traceability of measurement results to the Système International d’Unités (SI) or, where necessary, to other internationally agreed references; • promoting close links between Reference Laboratories in Laboratory Medicine and National Metrology Institutes; • co-ordinating and giving guidance in the establishment of Reference Measurement Systems with respect to medical needs;

  18. JCTLM • Implementation of • EC-IVD Directive (98/79/EC) • prEN ISO 17511 • EC-IVD Directive, Annex I, Essential requirements A.3 • '...The traceability of values assigned to calibratorsand/or control materials must be assured throughavailable reference measurement procedures and/oravailable reference materials of a higher order.'

  19. Membership • Principal promoters and stakeholders : • Worldwide International Organizations(to provide the essential formal international references): • BIPM, IFCC, ILAC, WHO(to be confirmed) • Other Key Stakeholders: • CRM-producers (notably IRMM and NIST) • IVD Industry (AdvaMed, EDMA, JACR) • EQA/Proficiency Organizations, Regulatory bodies, … • WASPaLM, ISTH • EC-DG Enterprise • ISO

  20. Organization Structure • JCTLM Executive • Priority setting • Decision on projects • Identification of appropriate organizations • 2002-2004: • Chairman - IFCC:Prof Joseph H H Thijssen • Secretariat - BIPM: Dr Angela E Samuel • Working Groups: WG 1: Reference Materials and Reference Procedures WG 2: Reference Measurement Laboratories

  21. National activities • Example 1: PTB, Germany • Clinical Chemistry

  22. our aim our strategy our competence Metrology in Chemistry in PTB Metrology in Chemistry in PTB reliability of chemical measurements sharing responsibilities Establishing traceability in analytical chemistry

  23. Metrology in Chemistry: aims and route • Metrology in Chemistry method route aim Installation of national traceability structures for chemical measurements (traceability to SI-units or other accepted reference points) establishment of international comparability/equivalency of national traceability structures • Reliable measurements: • sufficiently accurate • accuracy quantified • worldwide acceptance based on trust in accuracy • measured once - • accepted everywhere • application of metrological concepts • traceability • meas. uncertainty • in chemical analytics

  24. National infrastructure - International comparability NMI: Primäre Messverfahren + Prozeduren Primäre Referenzmaterialien NMI: primary measurement systems + devices primary reference materials accredited calibration laboratories, reference laboratories certified reference materials (CRMs) - SIM chemical test laboratories, which have to demonstrate their traceability (ISO 17025) BIPM

  25. Sharing responsibilities: a national network • BAMBundesanstalt für Material- forschung und -prüfung • primary pure substances • (elements) • primary gas mixtures • certified reference materials Large application fields require cooperation: health environment food high-tech materials commodities forensics • coordinator • our competence: • organics • element solutions • gases • electrochemistry • clinical chemistry • UBA Umweltbundesamt • primary gases for the • environment • DGKC Deutsche Gesellschaft für klinische Chemie • primary clinical • reference materials: - hormones - enzymatic activities - new diagnostic markers

  26. Activities in Clinical Chemistry PTB activity does not focus on issuing Reference Materials. Responsability is shifted to ,,Reference Laboratories‘‘. PTB coordinates and supports a network such laboratories by engaging in: • Measurement comparisons • Scientific dialogue • Research

  27. Regulations relevant to laboratory medicine • EC- Directive on In-Vitro Diagnostika 98/79/EG • Medizinproduktegesetz, Betreiberverordnung • Regulations of the Federal Physicians Association

  28. Measurands for which QA is mandatory Regulation, Appendix 1 (permanently updated) Selection for entry into Appendix: • Frequency of measurement • Medical importance of measurand • 55 measurands listed Uric acid Urea

  29. Assuring the quality of clinical measurements • Clinical Routine Laboratories purchase calibrators • from IVD industry. • Participate in comparisons (as a measure of • external quality control) organized by Reference Institutions. • Target values certified by Reference Laboratories. • Accreditation needed according to ISO 17025 or ISO 15195 • Comparisons PTBReference Laboratories. • Comparisons PTB  Community of NMIs. • CCQM

  30. Glucose Creatinine Uric Acid Urea Cholesterol Cortisol Testosterone Progesterone Estradiol Aldosterone Thyroxin Digitoxin/ Digoxin Theophylline Phenobarbital CCQM-K11 CCQM-K21 Substrates/ Metabolites i.p. i.p. CCQM-K6 i.p. Low Molecular Weight Hormones i.p. Therapeutic Drug Monitoring i.p.: in preparation

  31. LGC Setting standards in analytical science National activities • Example 2: LGC, UK • UK Chemical Calibration Facility

  32. Rationale for UK Programme • Analytical measurement sector is large and vital to the UK economy • ~£7.5bn of analysis p.a. • ~100,000 analysts in ~15,000 laboratories • Agreement between laboratories/countries is essential for commerce and international trade • Chemical measurement infrastructure poorly developed • Not all measurements are valid (fit for purpose)

  33. Chemical Measurement Infrastructure Activities • National: • VAM working groups (RM, PT, Training, Mass Spec.) • collaborative development of RMs • laboratory and knowledge networks with RSC • UK Chemical Calibration Facility • achieving traceability in ISO 17025 accredited laboratories • International: • established EURACHEM and CITAC • founder member of CCQM • participation in CIPM MRA and EUROMET

  34. UK Chemical Calibration Facility: 1. Purpose • Support the development of traceable chemical measurements by UK analytical laboratories, in particular to meet the requirements of ISO 17025 • Link UK laboratories into the national and international chemical measurement systems to ensure the future world-wide acceptance of their data • Provide a single point of focus for a wide range of chemical measurement services

  35. UK Chemical Calibration Facility:2. Principal Services • Provision of high level calibration services and/or standards to suppliers offering secondary services or standards • Preparation of standards and reference materials • Limited services direct to field laboratories, where necessary • Service provision in accordance with the CIPM Mutual Recognition Arrangement (MRA)

  36. UK Chemical Calibration Facility: 3. Initial Activities • Purity determination, including • Certification or provision of natural or isotopically enriched single substance calibration materials • Analytical standards, including • Certification or provision of solution calibration standards • Preparation and certification of complex matrix CRMs • Provision of reference values for matrix samples • CRMs, PT scheme artefacts, validation samples, etc

  37. Conclusions • MRA providing a basis for developing a worldwide infrastructure for chemical measurements • Linked National Activities vital to the process • Designation of laboratories: emerging mechanism

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