Abstract
IntroductionStandardization is the ability to obtain interchangeable results leading to same medical interpretation. External quality assessment (EQA) is the main support of the on-going harmonization initiatives. Aim of study was to evaluate results obtained from two years category 1 EQA program experience in Spain and determine the impact of applying this type of EQA program on the analytical standardization.Materials and methodsAccording to the analytical method, traceability and instrument different groups were established which results were evaluated by calculating mean, coefficient of variation and percent of deviation to the reference value. Analytical performance specifications used to the results' evaluation were derived from biological variation for bias and from the inter-laboratory coefficients of variation found in a previous pilot study.ResultsOnly creatinine measured by enzymatic methods gave excellent results, although few laboratories used this method. Creatine kinase and GGT gave good precision and bias in all, but one instrument studied. For the remaining analytes (ALT, ALP, AST, bilirubin, calcium, chloride, glucose, magnesium, potassium, sodium, total protein and urate) some improvement is still necessary to achieve satisfactory standardization in our setting.ConclusionsThe two years of category 1 EQA program experience in Spain have manifested a lack of standardization of 17 most frequent biochemistry tests used in our laboratories. The impact of the information obtained on the lack of standardization is to recommend abandoning methods such as ALT, AST without exogenous pyridoxal phosphate, Jaffe method for creatinine, and do not use non-commutable calibrators, such as aqueous solutions for calcium and sodium.
Highlights
Standardization is the ability to obtain interchangeable results leading to same medical interpretation
The two years of category 1 External quality assessment (EQA) program experience in Spain have manifested a lack of standardization of 17 most frequent biochemistry tests used in our laboratories
The impact of the information obtained on the lack of standardization is to recommend abandoning methods such as ALT, AST without exogenous pyridoxal phosphate, Jaffe method for creatinine, and do not use non-commutable calibrators, such as aqueous solutions for calcium and sodium
Summary
Standardization is the ability to obtain interchangeable results leading to same medical interpretation. External quality assessment (EQA) is the main support of the on-going harmonization initiatives. Standardization with category 1 EQA cations, so standardization among laboratories become one of the cornerstones of the quality patient‘s care. Standardization can be defined as the ability to obtain interchangeable results (within certain analytical quality uncertainty) in order to achieve the same medical decision, regardless of the analytical procedure (method, traceability and instrument), measurement units and reference intervals. The standardization should be based on six basic pillars, which include in vitro diagnostic companies, reference materials, reference methods, reference laboratories, medical laboratories and external quality assessment (EQA) organizations [1]. Greaves noted that EQA is not just a pillar but the central support for on-going harmonization [2]. Discordance in results between laboratories and methods should become a practice no longer accepted
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