NORIP, Malmö 27/4-2004

Implementation phase of NORIP

Gunnar Nordin,

EQUALIS, Uppsala

Common Nordic Reference Values, Session 15, NFKK 24 – 27 April 2004

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

NORIP, Malmö 27/4-2004

NORIP, Malmö 27/4-2004

How should X be used?

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!)

NORIP, Malmö 27/4-2004

Evaluation of results from X by the Excel sheet

NORIP, Malmö 27/4-2004

How should X not be used?

• X is not a substitute for the calibrators supplied by IVD manufacturers!

NORIP, Malmö 27/4-2004

Status of IFCC enzymesApril 2004

• Norway 100% (since May 2003)

• Denmark 50%

• Sweden 15%

• Finland (May 2004)

• Iceland (Autumn 2004?)

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.

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

NORIP, Malmö 27/4-2004

Implementation* of NORIP

in Sweden April 04

*) Exceptions for Potassiumand Calcium made in two districts.

Several districts plan forimplementation duringsummer and autumn 04

NORIP, Malmö 27/4-2004

NORIP, Malmö 27/4-2004

NORIP, Malmö 27/4-2004

Analysens CV% = 2,6

?

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

• ????

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

NORIP, Malmö 27/4-2004

Implementation of NORIP in Iceland

• Iceland:– Information will be given to clinicians and in

‘Lægeforeningens’ journal later this year

NORIP, Malmö 27/4-2004

Implementation of NORIP in Denmark

• DSKB has not yet recommended time for implementation of non-enzymes clinical chemistry.

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 K2-EDTA– Replacement of the old fashioned ‘% haematocrit’

with EVF (Sweden)

NORIP, Malmö 27/4-2004

NPU system for nomenclature and codes used in Denmark and Sweden

NPU01807P—Creatininium; subst.c.(Jaffé) = ? µmol/l

NPU04998P—Creatininium; subst.c.(enz.) = ? µmol/l

Two different codes for creatininium in plasma:

NPU04998 should be used for Jaffé-creatinineafter calibration with creatinine free serum!

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

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)