1. NORIP, Malmö 27/4-2004 Implementation phase of NORIP Gunnar Nordin, EQUALIS, Uppsala Common Nordic Reference Values, Session 15, NFKK 24 – 27 April 2004

2. NORIP, Malmö 27/4-2004 NORIP For the first time fully documented and traceable reference limit values Information needed to –Colleagues in the field of laboratory medicine –All requesters of tests in the health care systems –Others, e.g. organizers of multi center studies

3. NORIP, Malmö 27/4-2004

4. How should X be used?

5. NORIP, Malmö 27/4-2004 How should X be used? Evaluation and verification of the performance of routine clinical measurement procedures Make routine results traceable to common reference intervals for the Nordic countries (NORIP data) Laboratories not able to reproduce the stated values of X – try to find the reason! (together with the supplier!)

6. NORIP, Malmö 27/4-2004 Evaluation of results from X by the Excel sheet

7. NORIP, Malmö 27/4-2004 How should X not be used? X is not a substitute for the calibrators supplied by IVD manufacturers!

8. NORIP, Malmö 27/4-2004 Status of IFCC enzymes April 2004 Norway 100% (since May 2003) Denmark 50% Sweden 15% Finland (May 2004) Iceland (Autumn 2004?)

9. NORIP, Malmö 27/4-2004 Implementation of NORIP in Norway Implementation of clinical chemistry will start after publication and information in “Tidsskrift for Norsk Legeforening” June 2004. Checklist published on NKK website Implementation of haematology to be discussed.

10. NORIP, Malmö 27/4-2004 Implementation of NORIP in Sweden Implementation during 2004 recommended by SFKK. March 04 information in “Läkartidningen” Checklist on EQUALIS Website Users of Jaffémethods for creatinine are recommended by SFKK and EQUALIS to use creatinine free serum (see poster 78) April 04 full implementation by the pioneer laboratories

11. NORIP, Malmö 27/4-2004 Implementation* of NORIP in Sweden April 04 *) Exceptions for Potassium and Calcium made in two districts. Several districts plan for implementation during summer and autumn 04

12. NORIP, Malmö 27/4-2004

14. Analysens CV% = 2,6 ?

15. NORIP, Malmö 27/4-2004 Why might data not fit? Optimal preanalytical conditions in NORIP NORIP used serum tubes without gel Multiple tubes collected during venepunction ????

16. NORIP, Malmö 27/4-2004 Implementation of NORIP in Finland –Haematology implemented Jan 04 –Finnish Society recommends implementation in clinical chemistry May 04 –HUCS/HUS plan to implement May 04 –Other laboratories probably autumn 04

17. NORIP, Malmö 27/4-2004 Implementation of NORIP in Iceland Iceland: –Information will be given to clinicians and in ‘Lægeforeningens’ journal later this year

18. NORIP, Malmö 27/4-2004 Implementation of NORIP in Denmark DSKB has not yet recommended time for implementation of non-enzymes clinical chemistry.

19. NORIP, Malmö 27/4-2004 Secondary effects of NORIP General clinical chemistry: –Harmonization of Jaffé and enzymatic methods for creatinine –Test of the validity of the NPU system for the systematic nomenclature and codes for measured properties Haematology: –Common recommendation to use dry K 2 -EDTA –Replacement of the old fashioned ‘% haematocrit’ with EVF (Sweden)

20. NORIP, Malmö 27/4-2004 NPU system for nomenclature and codes used in Denmark and Sweden NPU01807 P—Creatininium; subst.c.(Jaffé) = ? µmol/l NPU04998 P—Creatininium; subst.c.(enz.) = ? µmol/l Two different codes for creatininium in plasma: NPU04998 should be used for Jaffé-creatinine after calibration with creatinine free serum!

21. NORIP, Malmö 27/4-2004 NPU system for nomenclature and codes used in Denmark and Sweden New NPU codes because new traceability New codes for new methods

22. NORIP, Malmö 27/4-2004 The future Evaluation of potential limitations of NORIP reference intervals, e.g. potassium, calcium and LD. –National EQA organizers should collect experiences from implementation –The NORIP working group (NOBIDA?) should be asked by NFKK to evaluate the final implementation Complete use of the collected data in the NORIP –E.g. reference intervals for the differential count, reticulocytes and other haematological properties Reference intervals for children. –Working group established by NFKK Further harmonization (???) –The unit katal for enzymes –Substance concentration for B-Haemoglobin (mmol/L)