Reporting LDL cholesterol results by clinical biochemistry laboratories in Czechia and Slovakia to improve the detection rate of familial hypercholesterolemia.

Introduction: This survey aims to assess the implementation of recommendations from the European Atherosclerosis Society (EAS) and the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) by clinical biochemistry laboratories in Czechia and Slovakia in their policies for reporting low-density lipoprotein cholesterol (LDL-C) concentrations. Materials and methods: The web-based survey was distributed to all 383 Czech and Slovak clinical biochemistry laboratories that measure lipids by external quality assessment provider SEKK. A total of 17 single-answer questions were included. The questionnaire was focused on the detection and decision points in familial hypercholesterolemia (FH). All survey answers were taken into account. The laboratories followed the EFLM and EAS guidelines when they reported an interpretative comment considering FH diagnosis in adults. Results: A total of 203 (53%) laboratories answered. Only 5% of laboratories added interpretative comments considering FH diagnosis when LDL-C concentrations are above 5.0 mmol/L in adults, and 3% of laboratories added interpretative comments considering FH diagnosis when LDL-C concentrations are above 4.0 mmol/L in children. Only 7% of laboratories reported goals for all cardiovascular risk categories (low, moderate, high, very high). Non-HDL cholesterol concentrations were calculated by 74% of responders. A significant number (51%) of participants did not measure apolipoprotein B, and 59% of laboratories did not measure lipoprotein(a). Conclusions: Only a small portion of laboratories from Czechia and Slovakia reported high LDL-C results with interpretative comments considering FH diagnosis in adults, the laboratories did not follow the guidelines.

External quality assessment providers' services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions.

OBJECTIVES: Medical laboratories may, at their own discretion, exceed but not undercut regulatory quality requirements. Available economic resources, however, may drive or hinder eagerness to exceed minimum requirements. Depending on the respective scopes of regulatory and economic framework conditions, differing levels of quality efforts to safeguard laboratory performance can be anticipated. However, this has not yet been investigated. METHODS: Immunohaematology external quality assessment (EQA) results collected by 26 EQA providers from their participant laboratories in 73 countries from 2004 to 2019 were evaluated. Error rates were aggregated in groups according to the respective national regulatory and economic framework conditions, to whether or not expert advice was provided in case of incorrect results, and the frequency of EQA samples. RESULTS: These representative data indicate no association between national regulatory (mandatory participation in EQA, monitoring of performance of individual laboratories by authorities, financial consequences of incorrect results) and economic (level of national income, share of national health expenditure) conditions to the quality performance of medical laboratories in immunohaematology. However, EQA providers' support for laboratories in the event of incorrect results appear to be associated with lower error rates, but a high EQA sample frequency with higher error rates. CONCLUSIONS: Further research into the impact of introducing or changing services of EQA providers is needed to confirm the results found in this first of its kind study.

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.].

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.