the role of eqa in harmonization of reference intervals in croatia labquality days, 2015, helsinki...
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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
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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
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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
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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)
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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
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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
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I phase: ANALYTICAL QUALITY
Croatian Chamber of Medical biochemists (CCMB)
Obligatory use of recommended analytical methods (IFCC methods)
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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
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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
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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
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LD
LD
before: CV= 27%
after: CV= 5%
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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)
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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
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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
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PRODUCTION OF REFERENCE VALUES
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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
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Document on national harmonization of laboratory results in the field of general medical biochemistry
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Reference Centre of the Ministry of Health for the Production of Reference Values, , University Hospital Merkur, Zagreb, Croatia
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Introduction of global reference intervals for those tests for which the reference measurement system is established
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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
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LABQUALITY DAYS, 2015, HELSINKI FINLAND
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LABQUALITY DAYS, 2015, HELSINKI FINLAND
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LABQUALITY DAYS, 2015, HELSINKI FINLAND
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LABQUALITY DAYS, 2015, HELSINKI FINLAND
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LABQUALITY DAYS, 2015, HELSINKI FINLAND
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LABQUALITY DAYS, 2015, HELSINKI FINLAND
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Thank you for your attention!
LABQUALITY DAYS, 2015, HELSINKI FINLAND