Identification of Reference Measurement Laboratories _________________________________________ JCTLM WG-2 Lothar Siekmann Institute of Clinical Biochemistry – University of Bonn, Germany

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

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

Identification of Reference Laboratories ________________________________________________________________________________________________________________ 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 and ISO as reference/calibration laboratory; or NMI listed in Appendix C of the CIPM MRA (peer reviewed), -on the basis of their ability to demonstrate performance in regular inter-laboratory comparisons (ring trials).

ISO 15195: Requirements for Reference Measurement (Calibration) Laboratories __________________________________________________________________________________________________ Management System Requirements Quality management system Personnel Documentation and records Contracting Technical Requirements Premises and environmental conditions Handling of samples Equipment Reference materials Reference measurement procedures Metrological traceability – Uncertainty Quality assurance Reporting results

IFCC EQAS for Reference Laboratories ________________________________________ Lothar Siekmann Institute of Clinical Biochemistry, Universität Bonn Reference Institute of Bioanalysis WG-2)

SUM160 SUM160

ALT in Human Serum IFCC RELA-2003 Sample ASample B U/L M (all) n10 SD (all) RSD (%)

Cholesterol in Human Serum CCQM-K6IFCC RELA-1 Meas. Principle IDMS Abell-Kendall Sample ASample BSample ASample BSample ASample B mg/g mg/dl M (all)2,19811, ,13166,81237,80171,36 n SD0,03240,02061,760,920,250,45 RSD (%)1,471,190,760,550,100,26 Range (%)5,144,152,251,440,260,64 Bias (%):2,92,7