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THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory Medicine, Reference Center of the Croatian Ministry of Health for the Production of Reference Values in the Feld of General Medical Biochemistry, Merkur University Hospital, Zagreb, Croatia Z. Flegar-Meštrić, V. Radišić Biljak

THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

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Page 1: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA

LABQUALITY DAYS, 2015, HELSINKI FINLAND

Department of Medical Biochemistry and Laboratory Medicine,

Reference Center of the Croatian Ministry of Health for the Production of Reference Values in the Feld of General Medical Biochemistry, Merkur University Hospital, Zagreb, Croatia  Z. Flegar-Meštrić, V. Radišić Biljak

Page 2: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

The role of EQA in harmonization of RI in Croatia

Clinical quality of laboratory results:reference intervals

Analytical quality of laboratory results:quality specifications – laboratory methods

National project: Harmonization of laboratory results

Page 3: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

National EQA is organised since 1973.

Voluntary Mandatory

Law on Medical Biochemistryon July 17, 2003.

The role of EQA in harmonization of RI in Croatia

Page 4: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

International EQA schemes

EQALM-EQALIS–IMEP 17: The International Measurement Evaluation Programme, 2007 (28 participants from Croatia)

EQALM International INR Project, 2008 (26 participants from Croatia)

EQALM-NOKLUS Project on Post-Analitycal Automated Haematology Survey, 2010; 2011; 2012 (each year 10 participants from Croatia)

EQALM -WBC Morphology Project -Effect of Storage on EDTA-Anticoagulated Blood Cell Morphology, 2012 (Merkur, University Hospital)

LABQUALITY MASTER SCHEME (Merkur, University Hospital)

Page 5: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

EQA data base:Harmonization of laboratory results

I phase

Analytical comparability of the results:obligatory use of recommended analytical methods

II phase

Clinical comparability of the results:- reference intervals for the Croatian population

GOALS

Page 6: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

Project Harmonization of laboratory results

Croatian Chamber of Medical Biochemists

Department of Medical Biochemistry and Laboratory Medicine, University Hospital Merkur, Reference center of the Ministry of Health for the production of reference values in the field of general medical biochemistry

Croatian Society of Medical Biochemistry and Laboratory Medicine

Page 7: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

I phase: ANALYTICAL QUALITY

Croatian Chamber of Medical biochemists (CCMB)

Obligatory use of recommended analytical methods (IFCC methods)

Page 8: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

CCMB RECOMMENDED METHODS

Expert committees of the Croatian Chamber of Medical Biochemists choose and recommended

the analytical methods to be used, in the field of:- Laboratory haematology- Laboratory coagulation- Biochemistry: metabolites, electrolytes,

mycroelements, enzymes, lipids, proteins, urine analyses

Page 9: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

2003: Low on Health Care

2003: Low on Medical Biochemistry

2004: CCMB - Rules on auditing MBLs and medical biochemists

2005: CCMB - Manual for auditing (Protocol, Self- Assessment Questionnaire, Criteria for Performance Evaluation

Professional and legal framework for quality improvement in Croatian

MBL

Page 10: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

testInterlab. CV%

before the use of recommended anal. methods

Interlab. CV%after the use of

recommended anal. methods

LD 27 5

CK 7 3

CHS 31 8

Long-term evaluation of EQA results: - after the obligatory use of the

recommended analytical methods

Page 11: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

LD

LD

before: CV= 27%

after: CV= 5%

Page 12: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

Reference values for the Croatian population:- Laboratory haematology- Laboratory coagulation- General medical biochemistry

( metabolites, electrolytes, mycroelements, enzymes, lipids, proteins, urine analyses

II phase: CLINICAL QUALITY(clinical comparability of laboratory results)

Page 13: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

Department of Medical Biochemistry and Laboratory Medicine, University Hospital Merkur-

Reference Centre of the Ministry of Health for the Production of Reference Values, Zagreb, Croatia

Page 14: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

Regional representative of WHO EQA in- IEQAS Lab. Haematology since 1985- IEQAS Lab. Coagulation since 1992- national EQA: 1978 - 2014

Todays activities are directed to standardization and harmonization in laboratory medicine

Accredited according HRN EN ISO 15189:2008 in 2007

Department of Medical Biochemistry and Laboratory Medicine, University Hospital Merkur-

Reference Centre of the Ministry of Health for the Production of Reference Values, Zagreb, Croatia

Page 15: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

PRODUCTION OF REFERENCE VALUES

Page 16: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

Reference values for the Croatian population in the field of general

medical biochemistry

n=2246 n=998

CHILDREN: 8 do 19 years

ADULTS: 20 do 70 yearsADULTS: 20 do 70 years

Representative reference

sample group

n=3244

http://www.kb-merkur.hr

Supported by the Ministry of Science, Education and Sports of the Republic of Croatia

Page 17: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

Document on national harmonization of laboratory results in the field of general medical biochemistry

Page 18: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

Reference Centre of the Ministry of Health for the Production of Reference Values, , University Hospital Merkur, Zagreb, Croatia

Page 19: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory
Page 20: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

Introduction of global reference intervals for those tests for which the reference measurement system is established

Page 21: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

What is the role of EQA in harmonization of laboratory results?

1. to provide a high-level overview of laboratory performance across different methods, and different analytical equipment

2.TO ENHANCE PATIENTS CARE THROUGH IMPROVED ANALYTICAL AND CLINICAL QUALITY OF LABORATORY RESULTS

Page 22: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

LABQUALITY DAYS, 2015, HELSINKI FINLAND

Page 23: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory
Page 24: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory
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Page 26: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory
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LABQUALITY DAYS, 2015, HELSINKI FINLAND

Page 30: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

LABQUALITY DAYS, 2015, HELSINKI FINLAND

Page 31: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

LABQUALITY DAYS, 2015, HELSINKI FINLAND

Page 32: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

LABQUALITY DAYS, 2015, HELSINKI FINLAND

Page 33: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

LABQUALITY DAYS, 2015, HELSINKI FINLAND

Page 34: THE ROLE OF EQA IN HARMONIZATION OF REFERENCE INTERVALS IN CROATIA LABQUALITY DAYS, 2015, HELSINKI FINLAND Department of Medical Biochemistry and Laboratory

Thank you for your attention!

LABQUALITY DAYS, 2015, HELSINKI FINLAND