1. JCTLM REFERENCE LABORATORY SERVICES Report of WG2 November 14, 2005 _________________________________________

2. Joint Committee for Traceability in Laboratory Medicine ______________________________________________________ Working Group I: -Reference Materials, -Reference Measurement Procedures Working Group II: -Reference Measurement Laboratories ______________________________________________________

3. Joint Committee for Traceability in Laboratory Medicine Declaration of Cooperation Appendix III: … The technical competence of the laboratories shall be demonstrated by their performance in international comparisons, and their operation of an appropriate quality system. International recognition of the implementation of the quality system is achieved via accreditation or equivalent documented peer review. … ______________________________________________________

4. Joint Committee for Traceability in Laboratory Medicine Working Group II Objectives: -to prepare a procedure manual describing the processes for nomination, listing and de-listing of reference laboratory services, -to publish an open call for nomination of reference laboratory services ______________________________________________________

5. Joint Committee for Traceability in Laboratory Medicine Working Group II Procedure Manual JCTLM WG2 P-00: Outline of the Calibration and Measurement Hierarchy in Laboratory Medicine - Quality Policy and Definitions ______________________________________________________

6. SI-Unit Definition of the Measurand BIPM, CGPM Primary calibrator Secondary calibrator Manufacturer‘s working (master) calibrator Mf.´s product calibrator Primary reference measurement procedure NMI, ARML NMI Secondary reference measurement procedure Manufacturer‘s standing measurement procedure End-user´s routine measurement procedure Routine sample RESULT NMI, ARML ARML, ML ML Manufacturer and/or End-user ML,ARML Traceability End-user Certification of a reference material (purity) ML µ c (y) BIPM: Bureau International of Weights and Measures CGPM: General Conference on Weights and Measures NMI: National Metrology Institute ARML: Accredited Reference Measurement Laboratory ML: Manufacturer‘s Laboratory

7. Hierarchy of Laboratories National Metrology Institutes Accredited Reference (Calibration) Laboratories (universities, hospitals, manufacturers) Routine (Testing) Laboratories

10. JCTLM WG2 – P-02

12. Joint Committee for Traceability in Laboratory Medicine Working Group II Procedure Manual JCTLM WG2 P-01: Outline of the JCTLM Procedures for Identifying and Listing Reference Measurement Services Provided by Reference Laboratories ______________________________________________________

14. Joint Committee for Traceability in Laboratory Medicine Working Group II Procedure Manual JCTLM WG2 P-02: Process for Requesting and Processing Nominations for JCTLM Listing of Reference Measurement Services ______________________________________________________

16. 7.1 The process for nominating and reviewing RML services for recommendation by the JCTLM for listing will occur annually (see flow chart in the Attachment). 7.2 Solicitation of Nominations from RMLs wishing their services to be listed on the JCTLM List: 7.3 Obtaining Nomination Forms: 7.4 Submitting Nomination Forms for Consideration by WG2. 7.5 Preliminary Review of submitted nominations for completeness by the JCTLM Secretariat. 7.6 The JCTLM Secretariat and the WG2 Chair or the Chair’s designee review nominations within six weeks of their receipt. 7.7 Distributing Nominations from National Metrology Institutes to the JCTLM/CCQM Executive Secretariat. 7.8 Distributing Nominations from Accredited Laboratories (or Laboratories preparing for Accreditation) to Review Teams. 7.9 Any Review Team member affiliated to a nominating organization will not participate in the evaluation of that reference measurement laboratory service if a potential conflict of interest exists or is perceived to exist. 7. Procedure JCTLM WG2 – P-02

17. 7.10 The distributed nominations from National Metrology Institutes are verified by the JCTLM/CCQM Secretariat. 7.11 The distributed nominations of Reference Measurement Service providers are reviewed by the Review Teams. 7.12 For laboratories where accreditation is pending (7.7.1.2) the status of accreditation is re-examined in 2009 by the JCTLM Secretariat after consulting WG2 chair. 7.13 Reference measurement services listed on the JCTLM website will be re-reviewed every three years. 7.14 Any appeal against decisions of WG2 chair or review teams will be submitted to the Secretariat and finally decided by the JCTLM Executive after consulting the WG2 chair. 7. Procedure (continued) JCTLM WG2 – P-02

18. 8. Requirements for acceptable proficiency testing scheme providers 8.1 The proficiency testing provider should organize intercomparisons dedicated to reference measurement laboratory services. 8.2 The proficiency testing provider should be accredited according to ISO Guide 43-1 (1997) and ILAC Guide G-13 (2000) by an ILAC member. 8.3 The proficiency testing provider should have an international scientific advisory board. 8.4 The proficiency testing provider should conduct intercomparisons regularly (at least annually). 8.5 The proficiency testing provider should ensure that communication is established and that scientific advice is available to resolve inter-laboratory discrepancies. 8.6 The proficiency testing provider should make publicly available the identity of the participating laboratories with their results and uncertainties. JCTLM WG2 – P-02

19. Joint Committee for Traceability in Laboratory Medicine Working Group II Procedure Manual JCTLM WG2 P-03-A: Process for Verification and Publication of Calibration and Measurement Capability (CMC) Claims in the JCTLM Database (National Metrology Institutes) ______________________________________________________

21. Joint Committee for Traceability in Laboratory Medicine Working Group II Procedure Manual JCTLM WG2 P-03-B: Process for Review of Reference Measurement Services from Laboratories that are Accredited as Calibration Laboratories (ISO/IEC 17025 and ISO 15195) ______________________________________________________

23. 7. Procedure 7.1 The process for reviewing RML services by the Review Teams will take place annually. WG2 chair will send documentation from the candidate RMLs to the review teams. They will assess the documentation and other publicly available information according to the following criteria: 7.1.1 Review teams ascertain that the RML is accredited according to ISO/IEC 17025 and ISO 15195 as calibration laboratory including on-site assessment by ILAC full members on the basis of on-site assessments by technical and management experts from accreditation bodies which are ILAC full members. 7.1.2 Review teams ascertain whether the Reference Method applied by the candidate laboratory is listed by the JCTLM according to the WG1 procedure. If the applied method has not yet been included in the WG1 reference method list the laboratory will be notified to nominate the procedure for acceptance by JCTLM WG1. 7.1.3 Review teams ascertain regular (at least annual) participation of the candidate laboratory in inter- laboratory comparisons provided by an appropriate proficiency testing/external quality assessment scheme for reference laboratories which fulfills the requirements of WG-2 P-02-8. The results of the inter-comparisons as well as the result of the individual laboratory related to its identity shall be publicly available. It is also acceptable that a laboratory participates for another measurand of the same group of quantities (e.g., metabolites & substrates, low-molecular hormones, therapeutic drugs, enzymes) provided the same principle of measurement - e.g., IDMS, kinetic spectrophotometry for enzyme activities - is applied. JCTLM WG2 – P-03-B

24. Joint Committee for Traceability in Laboratory Medicine Working Group II Procedure Manual JCTLM WG2 P-03-C: Process for Review of Reference Measurement Services from Laboratories Preparing for Accreditation ______________________________________________________

26. Joint Committee for Traceability in Laboratory Medicine Working Group II Procedure Manual JCTLM WG2 P-04: Process for Listing Reference Measurement Laboratory Services ______________________________________________________

28. Joint Committee for Traceability in Laboratory Medicine Working Group II Procedure Manual: JCTLM WG2 P-05: Process for Delisting Reference Measurement Laboratory Services ______________________________________________________

30. Reference Measurement Laboratories will be identified - according to the metrological level of the reference procedures applied; JCTLM –listed  WG1, - on the basis of accreditation according to ISO 17025 and ISO 15195 as reference/calibration laboratory including on-site assessments by ILAC full members (signatories); or NMI listed in Appendix C of the CIPM MRA (peer reviewed), - on the basis of their ability to demonstrate performance in regular (at least annual) inter-laboratory comparisons (ring trials).

31. Candidate Reference Laboratories in Laboratory Medicine Questionnaire Database (Do not use the 'return key' within a cell; continuous writing will fill up additional lines!) (Please use one entry (line) for each measurand!) Reference Laboratory Address Status of Reference Laboratory Organisation Name of person responsible StreetCity Post Code StateCountryPhoneFaxe-mail indicate: Nat.Metrology Institute, EQAS Organizer, Manufacturer, University, Hospital Procedure Manual: P-02-7.4.4.1

32. MeasurandReference Measurement Procedure Type of Measu rand Ana lyte System (e.g.: Blood, Serum, Plasma, Urine) SI- traceable (Yes/No) Principle of analytical procedure (Please attach a short outline of the procedure in a separte document!) Reference Method listed in JCTLM List of Reference Methods (Yes / No) Reference material(s) for calibration Reference material(s) for trueness control Literature Reference Range of Concentration (Activity) Uncertainty of Results Status: Reference Procedure Acceptable and Listened by JCTLM WG-1 (Yes / No) P-02-7.4.4.2 P-02- 7.4.4.3 P-02-7.4.4.4/5 P-02- 7.4.4.6 P-02- 7.4.4.7 P-02-7.4.4.8 P-02- 7.4.4.9 P-02-7.4.4.10 P-02- 7.4.4.11

33. Status of Laboratory NMI with CMC listed in Appendix C of BIPM KCDB (Yes/No) According to ISO 17025 and ISO 15195 as Calibration Laboratory (Yes/No) Laboratory declares that it is preparing for Accreditation until 2008 Proc. Manual P-03-C (Yes / No) Status of Laboratory (a) NMI listed in BIPM KCDB (b) Accredited (ISO 17025+15195) (c) Accreditation in Preparation (d) NO P-02-7.4.4.12 P-03-A P-02-7.4.4.13 P-03-B P-02-7.4.4.14 P-03-C

34. Participation in Intercomparison Surveys for Reference Laboratories Survey Organisation, Network Results of intercomparisons publically available e.g. on a Website? (Yes / No) Identity of the Laboratory Disclosed and Related to its Results? (Yes / No) Frequency of participation für one or more measurands in the relevant group of measurands Status : participation in intercomparison surveys acceptable ? (Yes / No) P-02-7.4.4.15 - P-03-A - P03-B - P-03-C

35. Frequency of Measurements RemarksComments of Review Teams in 2003in 2004in 2005

39. 17-OH-Progesterone Ring Trial HM4/2004 Test Kit 111