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Standardization of HbA1c in Croatia: External Quality Assessment Scheme as a powerful tool in the Global Consensus implementation

Efficient implementation of globally accepted standards is a key-prerequisite in assuring quality of diabetes care. Global Consensus on the standardization of HbA1c, proposing dual reporting-system: SI (mmol/mol) and NGSP-derived (%), requires concerted implementation to the laboratories, together with both laboratory- and medical professional-oriented education. The aim of this study was to investigate the power of the national External Quality Assessment Scheme (EQAS) in the delivery of Global Consensus to the Croatian medical biochemistry laboratories. A dedicated module for HbA1c was established within EQAS under the auspices of the Croatian Society of Medical Biochemists in 2005, with a primary goal to improve analytical quality and provide data for interlaboratory comparisons. After a total of 10 EQAS-cycles, HbA1c testing in Croatia considerably improved in both quantity (48 vs. 27 laboratories in 2010 and 2005, respectively) and compliance to the worldwide standardization guidelines. By the end of 2009 all laboratories were using methods traceable to the IFCCreference system, with reporting units harmonized to the NGSP/DCCT-equivalents (%). After an announcement of the Global Consensus details on the website of the Croatian Chambers of Medical Biochemists, a pilot-scheme for dual reporting was organized within regular EQAS-cycle in December 2010. Participating laboratories (n=48) were provided with a modified result-form, covering both units, and a short explanation of the Global Consensus goals in Croatian language, together with HbA1c conversion table. Results of a pilot-scheme revealed an excellent compliance to the cycle-specific instructions: 47/48 laboratories returned their results in dual system of reporting. As regards methods, 92% of the laboratories were using immunochemical methods, anchored to the IFCC-reference system, with respective, manufacturer-provided master-equations for conversion between SI- and NGSP/DCCT-units. The rest of laboratories (n=4) were using other methods, and only one didn't comply to the instructions, requiring further education on the subject. Our results reveal that EQAS might be a valuable tool in transferring Global Consensus to the national level. Based on these results, and respective educational activities, dual system of HbA1c reporting was successfully implemented in Croatian laboratories as of January 2011.

HbA1c; global consensus; EQAS

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