Corrigendum to: Assessment of the degree of adherence of medical laboratories to KDIGO 2012 guideline for evaluation and management of CKD in Czechia and Slovakia.

[This corrects the article DOI: 10.11613/BM.2019.030704.].

A pragmatic proposal for permissible limits in external quality assessment schemes with a compromise between biological variation and the state of the art.

Permissible limits for internal and external quality assurance are either based on biological variation or on the state of the art (technical feasibility). The former approach has a scientific basis, but, in some cases, leads to limits which are either not achievable under the present technology, or which are not stringent enough. If proficiency testing is mandatory, stringent limits which cannot be fulfilled by the majority of laboratories could lead to juristic consequences. Therefore, most national guidelines were based on the state of the art, however, without providing the underlying reasoning. A simple algorithm for permissible limits in external quality assessment schemes (EQAS) is proposed based on biological variation, technical feasibility and correlated to the rate of false positive results. The proposed limits are compared with some limits from several EQAS (RiliBÄK, SEKK, RCPA, CLIA, PROLARIT). The suggested limits are slightly more stringent than the German RiliBÄK, less stringent than the Australasian guidelines and agreed best with the Czech SEKK and the Italian PROLARIT scheme. The graphical presentation of permissible limits strictly derived of biological variation with the proposed limits led to straight lines with different slopes and a cross-over at the limits for quantities with a medium biological variation (e.g., trijodthyronine). The greatest discordance between the various recommendations was observed for calcium, chloride, hemoglobin A(1c) and sodium.

Estimation of trueness of measurement results obtained in external quality assessment.

BACKGROUND: We demonstrated that lyophilised EQA/PT control materials, under certain circumstances, provide equal information about bias values as pools of native patient sera, and that in some cases, long-term reliable work with such materials is possible. METHODS: Bias values, estimated from results of routine surveys of EQA SEKK (Czech Republic) programmes for eight basic blood serum analytes using lyophilised control materials, were compared with bias values reached in the CAP (USA) programme where pools of native and lyophilised patient sera were used. RESULTS: Results for the components Na, K, Mg, Cl, P, urea, glucose, and uric acid were assessed. No significant differences were found between the bias values estimated by CAP using native sera, and those estimated by SEKK using lyophilised sera. CONCLUSIONS: It can be concluded that well-prepared lyophilised control materials may show the required commutability level. If so, they constitute a practical and cost-efficient alternative to native or fresh frozen sera when assessing bias.

Quality of serum creatinine measurement in light of EQA programs.

BACKGROUND: The aim of our study was to identify the role of External Quality Assessment (EQA) programs in improving the quality of serum creatinine measurement and glomerular filtration rate (GFR) estimation. Comparison of results achieved during EQA with National Kidney Disease Education Program and College of American Pathologists guidelines identified an urgent need for an improvement in measurement quality. We compared actual results for serum creatinine measurement within the Czech Republic EQA with the requirements of EC Directive 98/79. METHODS: We used the results for 2005-2006 EQA programs. There were seven surveys involved with two samples each, and a 2006 questionnaire on the post-analytical phase survey. RESULTS: Bias depended strongly on the creatinine concentration. However, this dependence varied for different in vitro diagnostic manufacturers, although they should all follow the same directive. We chose biological variation as the significance rate for bias and a resulting overall error of 6.9%. The proportion of results with total error <6.9% ranged from 11% to 80%. The total error for a reference sample of 94.8 mumol/L also showed significant dependence on the working calibrator used and ranged from 1% to 17%. CONCLUSIONS: The main role of EQA programs in improving the quality of creatinine measurement results and GFR calculation should be in monitoring the quality of IVD products, enabling users to adapt their use of these products accordingly. EQA programs can also educate on performing GFR estimation in a unified way. Highly commutable control materials with certified creatinine values or, alternatively, lyophilized materials with sufficient commutability proved by comparison with native frozen human sera, should become an important EQA tool.

Pilot external quality assessment survey for post-market vigilance of in vitro diagnostic medical devices and investigation of trueness of participants' results.

The Czech External Quality Assessment Scheme organized a survey using 14 fresh-frozen sera targeted for cholesterol and glucose by reference measurement procedures. The objective was to investigate whether it could fulfil a post-market vigilance function for in vitro diagnostic medical devices and assess trueness of participants' results. It revealed a mean bias of +5.1% for cholesterol and +3.7% for glucose (n approximately 150). However, the bias source (manufacturer or laboratory) could not be identified unequivocally because of the lack of homogeneous groups. This was due to the fact that laboratories mainly used reagents from manufacturers that do not market instruments or combined calibrators and reagents from different sources. Consequently, these habits did not allow the survey to fulfil the vigilance function. On the other hand, we were able to show the individual participants results for patient samples deviating from the true value (deviations >10% in approximately 20% of the laboratories). However, again, the survey failed in problem-solving via peer-group evaluation, even for participants that applied homogeneous tests. If other European schemes confirm this outcome, cooperation and/or participation of manufacturers may be the solution. The survey pointed out to the other participants, interchanging instrument, reagent and calibrator, that they are themselves responsible for the problems shown and hence also for problem-solving.