Harmonisatie. Cas Weykamp SKML Sectie Humorale Immunologie Congres De Waarde van de Expert 9 juni 2015

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Bernard Hodges
8 years ago
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1 Harmonisatie Cas Weykamp SKML Sectie Humorale Immunologie Congres De Waarde van de Expert 9 juni 2015

2 Patient

3 Patient Optimale Diagnose Behandeling

4 Patient Optimale Diagnose Behandeling

5 Patient Optimale Diagnose Behandeling Optimale Diagnose & Behandeling = Optimale Test:

6 Patient Optimale Diagnose Behandeling Optimale Diagnose & Behandeling = Optimale Test: - Zelfde Uitkomst - Zelfde Referentiewaarden - Zelfde Beslisgrenzen - Zelfde Literatuur

7 Patient Optimale Diagnose Behandeling Optimale Diagnose & Behandeling = Optimale Test Analytisch Fundament

8 Patient Optimale Diagnose Behandeling Transfer Optimale Diagnose & Behandeling = Optimale Test Analytisch Fundament

9 Patient Optimale Diagnose Behandeling Optimale Diagnose & Behandeling = Optimale Test Checks/Balances Analytisch Fundament

10 Patient Optimale Diagnose Behandeling Transfer Optimale Diagnose & Behandeling = Optimale Test Checks/Balances Analytisch Fundament

11 Optimale Patient Analytisch Fundament

12 Optimale Patient Transfer Analytisch Fundament

13 Optimale Patient Transfer Fabrikant Analytisch Fundament

14 Optimale Patient Transfer Fabrikant Analytisch Fundament

15 Optimale Patient Checks/Balances Analytisch Fundament

16 Optimale Patient Checks/Balances SKML Analytisch Fundament

17 Optimale Patient Checks/Balances SKML Analytisch Fundament

18 Optimale Patient Transfer Fabrikant Checks/Balances SKML Analytisch Fundament

19 Optimale Patient Analytisch Fundament Transfer Fabrikant - Referentie Methode - Referentie Materiaal - Wereldwijde Erkenning - Wereldwijd Gebruik Checks/Balances SKML door Rondzenders door Fabrikanten

20 Analytisch Fundament Standardize if possible Harmonize if standardization is not possible

21 Traceability of Laboratory Results Differences between harmonization and standardization Ø Harmonization: all measurement procedures get the same result for a sample when there is no reference measurement procedure (RMP) Ø Standardization: all measurement procedures get the same result for a sample and the result is traceable to SI with a RMP

22 Definition of the Analyte Traceability Chain Primary Calibrator Primary Reference MP Secondary Calibrator Secondary Refer. MP Manufacturer s Working Calibrator Manufacturer s Product Calibrator Manufactuer s Internal MP Manufacturer s Standing MP Patient Sample Routine MP in Lab Standardization Interpretation Patient Result

23 ISO 17511: Metrological traceability of values assigned to calibrators and control materials Standardization Category Reference measurement procedure Primary (pure substance) reference material Secondary (value assigned) reference material a 1 Yes Yes Possible Examples Electrolytes, glucose, cortisol 2 Yes No Possible Enzymes 3 Yes No No 4 No No Yes Hemostatic factors Proteins, tumor markers, HIV b 5 No No No EBV c, VZV d Harmonization

24 SKML en Standaardisatie/Harmonisatie Draagt Internationaal bij aan Ontwikkeling - IFCC (HbA1c CDT) - AACC (Harmonization Initiative) Past het toe in de Rondzendingen - Combi Algemene Chemie (2005) - Combi Immuno Chemie (2014)

25 SKML en Standaardisatie/Harmonisatie Draagt Internationaal bij aan Ontwikkeling - IFCC (HbA1c CDT) - AACC (Harmonization Initiative) Past het toe in de Rondzendingen - Combi Algemene Chemie (2005) - Combi Immuno Chemie (2014)

26 ISO 17511: Metrological traceability of values assigned to calibrators and control materials Combi Algemene Chemie Standardization Category Reference measurement procedure Primary (pure substance) reference material Secondary (value assigned) reference material a 1 Yes Yes Possible Examples Electrolytes, glucose, cortisol 2 Yes No Possible Enzymes 3 Yes No No 4 No No Yes Hemostatic factors Proteins, tumor markers, HIV b 5 No No No EBV c, VZV d Harmonization Combi Immuno Chemie

27 ISO 17511: Metrological traceability of values assigned to calibrators and control materials Standardization Category Reference measurement procedure Primary (pure substance) reference material Secondary (value assigned) reference material a 1 Yes Yes Possible Examples Electrolytes, glucose, cortisol 2 Yes No Possible Enzymes 3 Yes No No 4 No No Yes Hemostatic factors Proteins, tumor markers, HIV b 5 No No No EBV c, VZV d Harmonization Combi Immuno Chemie

28 Optimal Immuno Chemie Patient Transfer Fabrikant Checks/Balances SKML CRM 470 (ERM-DA470k/IFCC)

29 Optimale Immuno Chemie Patient Analytisch Fundament - Referentie Methode? Transfer Fabrikant - Referentie Materiaal? - Wereldwijde Erkenning? - Wereldwijd Gebruik doorrondzenders? door Fabrikanten? Checks/Balances SKML

30 Optimale Immuno Chemie Patient Analytisch Fundament Transfer Fabrikant - Referentie Methode? Arb. (IRMM) - Referentie Materiaal? Ja (CRM 470) - Wereldwijde Erkenning? Ja - Wereldwijd Gebruik Checks/Balances SKML doorrondzenders? SKML 2014 door Fabrikanten? Nou

31 Optimal Immuno Chemie Patient Transfer Fabrikant? Checks/Balances SKML CRM 470 (ERM-DA470k/IFCC)

32 Bedankt voor Uw Aandacht

Graham Beastall. gbeastall@googlemail.com. Outline of Talk

Graham Beastall. gbeastall@googlemail.com. Outline of Talk Harmonization of Methods in Laboratory Medicine: A Means to Improve Patient Safety Graham Beastall gbeastall@googlemail.com Outline of Talk Introduction Why Standardize or Harmonize Methods? Traceability