SULM – Schweizerische Union für Labormedizin | Union Suisse de Médecine de Laboratoire | Swiss Union of Laboratory Medicine

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1Clinical Hospital Merkur, Institute of Clinical Chemistry, Zagreb, Croatia, 2Faculty of Pharmacy and Biochemistry, Department of Medical Biochemistry and Hematology, Zagreb, Croatia

Objective. External quality assessment program in Croatia has been continuously performed since 1973 by the Committee for External Quality Assessment Schemes under the auspices of the Croatian Society of Medical Biochemists. The program is managed three times per year and includes clinical chemistry, laboratory hematology, coagulation, complete urine analysis and since 2003 acid base analysis.
Methods. External quality assessment in acid base analysis was performed by using different specimens of the buffered bicarbonate solution equilibrated with predetermined level of oxygen, carbon dioxide and nitrogen. The blood gas analysis were performed in 41 medical biochemical laboratories on the instruments from different manufacturers including Bayer Diagnostics (51%), Instrumentation Laboratories, (17%), Nova Biomedical (12%), Radiometer (10%), and the others (10%).
Results. The results for pH, pCO2 and pO2 for all laboratories were within quality criteria according the new German quality regulation for near-patient testing applications which specify allowable total errors of 0.06 for pH, 12% for pCO2 and 12 % for pO2 more than 13.3 kPa or 1.6 kPa when less than 13.3 kPa, and according to the Clinical Laboratory Improvement Amendments (CLIA) which specify allowable total errors of 0.04 for pH, 8% for pCO2 and 8 % or ± 3SD for pO2. Results for pH were within acceptable range according to the manufacturers' recommendations for 87-90% laboratories, for pCO2 for 85-95 % laboratories and for pO2 for 77-85 % laboratories.
Conclusion. According to the obtained results the most important problem in the external quality assessment in acid base analysis is the matrix of the control material, which is different from the real biological samples. For this reason it seems that grouping of the analyzers according to the manufacturers is the best way for performance evaluations and between instrument comparison.


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