JCTLM Structure and future funding of the JCTLM Secretariat

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1 Harmonization Task Force Meeting 2012 JCTLM Structure and future funding of the JCTLM Secretariat R.I. Wielgosz BIPM JCTLM Database :

2 BUREAU INTERNATIONAL DES POIDS ET MESURES The BIPM is an intergovernmental organization established by the Metre Convention, through which Member States act together on matters related to measurement science and measurement standards. The mission of the BIPM is to ensure and promote the global comparability of measurements, including providing a coherent international system of units for: Scientific discovery and innovation, Industrial manufacturing and international trade Sustaining the quality of life and the global environment. Working with National Metrology Institutes and other Stakeholders from around the world: 55 Member States 38 Associates

3 CIPM Consultative Committee Structure CIPM BIPM Other International Organizations (Governmental and NGOs) CCAUV Acoustics, Ultrasound and Vibration JCGM: Guides in Metrology CCEM CCL CCM CCPR CCQM CCRI CCT CCTF CCU Electricity and Magnetism Length Mass and Related Quantities Photometry and Radiometry Amount of Substance (Chemistry and Biology) Ionizing Radiation Thermometry Time and Frequency Units JCRB: CIPM-MRA JCTLM: Traceability in Laboratory Medicine DCMAS Network: Developing Economies

4 JCTLM established in 2002: Intergovernmental Treaty Organization for Measurement Standards International NGO for Professionals in Laboratory Medicine International NGO for Accreditation Bodies 4

5 JCTLM at the BIPM

6 JCTLM at the BIPM BIPM Chemistry Department Director: R.I. Wielgosz International Equivalence of Standards for Greenhouse and Air Quality Gases J.Viallon E. Flores P. Moussay F. Idrees S. Lee (KRISS) International Equivalence of Organic Primary Standards S. Westwood R. Josephs N. Stoppacher A. Daireaux T. Choteau M. Li (NIM) International Coordination CCQM JCTLM S. Maniguet

7 BIPM coordinated key comparisons on Organic Primary Standards International Comparisons on purity determination of primary reference materials Year Comparison Code Main Component x ref (mg/g) u(x ref ) (mg/g) 2006 CCQM-P20.e.1 Theophylline CCQM-P20.e.2 Theophylline CCQM-P20.f Digoxin /2009 CCQM-K55.a Estradiol /2011 CCQM-K55.b Aldrin CCQM-K55.c Valine 2014/2015 CCQM-K115 C-peptide

8 CCQM-P20.f- Digoxin Purity Comparison Results Digoxin content: P20.f 1000 k=1 Mass fraction (mg/g) NMIA BIPM NIST NMIJ USP DA USP RS CENAM LGC NIM NIMT DMSc NRCC DGKL MP

9 CCQM-K55 Purity Comparison Results Results available in BIPM key comparison database (KCDB)

10 Reference Methods for Primary Reference Material Purity Characterization (2013)

11 JCTLM established in 2002: Intergovernmental Treaty Organization for Measurement Standards International NGO for Professionals in Laboratory Medicine International NGO for Accreditation Bodies 11

12 Executive Committee President: M. Muller (IFCC) Executive Secretary: R. Wielgosz (BIPM) Operational Structure Working Groups 1. Reference Materials and Reference Methods Chairs: K. Phinney (NIST), H. Schimmel (IRMM), Compilation of existing RMPs and CRMs (Lists) 2.Reference Laboratories Chairs: L. Siekmann, L. Thienpont (IFCC) Lists of Laboratory Reference Measurement Services (RMSs) 12

13 JCTLM Member Organizations (26) 13

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15 Operational Structure 15

16 What has JCTLM delivered? A Quality assured database of: a) Higher Order Reference Materials b) Reference Measurement Procedures c) Laboratory Reference Measurement Services For use by (primarily) a) IVD industry b) Regulators

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18 JCTLM Working Group II - Reference Measurement Services for Laboratory Medicine

19 JCTLM Database :

20 JCTLM Database Update (from July 2011 to July 2012)

21 Visits to the JCTLM Database of the last 4 years 1000 to 1400 visits per month Visit = Extended consultation of web pages

22 JCTLM Database Status December 2013 Certified Reference Materials Total number of entries is 299 among which - 33 are in List II (non-si traceable ), and 3 in List III (nominal properties) - 35% of the listed items are high purity materials (was 25% in 2012)

23 JCTLM Database Status December 2013 Certified Reference Materials

24 JCTLM Database Status December 2013 Reference measurement methods/procedures Analyte Category Number of submissions listed Number of Matrix Analyte Number of Analytes Blood cell counting (2013) Blood gases Blood groupings Coagulation factors Drugs Electrolytes Enzymes Metabolites and Substrates (2013) 44 (1) Microbial serology Non Electroyte Metals Non-peptide Hormones Nucleic acids Proteins (2013) 19 (-1) 16 (-1) 16 (-1) Vitamins Total :

25 JCTLM Database Status December 2013 Reference measurement methods/procedures In 2012 publication of two outstanding Blood Cell Counting Methods, and in 2013 Total protein measurement method placed in the list of no longer listed methods.

26 Relevant ISO Standards for higher order RMs and RMPs ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials ISO 18153:2003 Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials ISO 15193:2009 Requirements for content and presentation of reference measurement procedures ISO 15194:2009 Requirements for certified reference materials and the content of supporting documentation ISO 15195:2003 Reference Measurement Laboratories

27 ISO 15193:2009 and ISO 15194:2009 Harmonized standards

28 JCTLM Database Status December 2013 Reference measurement services 92 reference measurement services listed 9 Reference Laboratories accredited for compliance with ISO ISO/IEC and 2 NMIs

29 Accreditation of Reference Laboratories 15 accreditation bodies (4 Asia; 11 Europe)

30 Proposal for JCTLM Workshop Reference Laboratories and Accreditors Proposal for JCTLM to organize a workshop with major stakeholders (users) for ISO (including reference measurement laboratories and accreditation bodies intending to provide accreditation services to labs for a combination of ISO and ISO 17025) to elucidate best practices and challenges in this area, and to solicit proposals/ideas for revisions and improvements to ISO Proposal supported by ISO TC 212 WG2 (Reference Systems)

31 JCTLM Meetings and Workshops Since 2004 JCTLM WG Meetings: 10 (2004, 2005 (2), 2007, 2008, 2009, 2010, 2011, 2012, 2013) JCTLM Executive Meetings: 12 (2004(2), 2005(2), 2006, 2007, 2008, 2009, 2010, 2011, 2012,2013) JCTLM Member and Stakeholder meetings: 5 (2002, 2004, 2005, 2008, 2013) JCTLM Workshops/Symposia: 8 (2004, 2007, 2008, 2009, 2012 (2), 2013 (2)) JCTLM Symposium on Reference Measurements Systems for Biologicals (2004) Activities and Challenges for International Standardization and Traceability in Laboratory medicine (2007) JCTLM Industry Workshop, Nucleic Acids and Immunoassays (2008) NIST/JCTLM/CCQM workshop on measurement standard need for next generation healthcare delivery (2009) JCTLM meeting on HbA1c Reference Measurement Systems (2012) JCTLM Industry Meeting (2012) Workshop on Commutability (2013) Workshop on the impact of reference measurement systems on clinical evidence (2013)

32 Resources required to operate the JCTLM

33 Resources required to operate the JCTLM per year JCTLM Body Number of man-days Executive 16 WG Chairs 10 Secretariat 85 Review Teams Secretariat activities co-funded on 50:50 basis by IFCC and BIPM (since 2004) - Maintaining review process - Includes database maintenance Financial support for US based meetings provided by NIST Review Teams work on voluntary basis with no reimbursement of travel expenses

34 JCTLM Database going forward 1. JCTLM Database is at a stage of steady growth/ state, e.g. 300 Certified Reference Materials listed (89% SI traceable; 10% non-si traceable; 1% nominal properties); 1200 visits to the JCTLM Database per month 40 to 60 nominations of CRMs received a year for review 2. Number of JCTLM listed Reference Laboratories is expected to increase Strong growth in numbers from Asia (based on IFCC-RELA participation) Numbers in Europe are steady (may increase incrementally) North/South America? 3. Current process heavily dependent on Coordination activities of the JCTLM Secretariat Volunteer time of Review Team Members

35 JCTLM going forward 1. Does the JCTLM database constitute a valuable database for the IVD sector and industry? 2. Is the JCTLM structure sufficiently inclusive? 3. Is the model of 3 sponsoring organizations and 26 member organizations still correct? 4. Can we attract more organizations to support the JCTLM? 5. Are the JCTLM processes and way of working still appropriate? 6. Should the JCTLM refocus its activities? 7. Can the JCTLM attract further financial support from interested organizations? 8. Are there other funding models that would be appropriate and feasible?