Optimizing the use of the “state-of-the-art” performance criteria

2015 ◽  
Vol 53 (6) ◽  
Author(s):  
Rainer Haeckel ◽  
Werner Wosniok ◽  
Thomas Streichert
Keyword(s):  
State Of The Art ◽  
Clinical Chemistry ◽  
Reference Interval ◽  
German Society ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
The State ◽  
Analytical Performance ◽  
Performance Criteria ◽  
Performance Goals

AbstractThe organizers of the first EFLM Strategic Conference “Defining analytical performance goals” identified three models for defining analytical performance goals in laboratory medicine. Whereas the highest level of model 1 (outcome studies) is difficult to implement, the other levels are more or less based on subjective opinions of experts, with models 2 (based on biological variation) and 3 (defined by the state-of-the-art) being more objective. A working group of the German Society of Clinical Chemistry and Laboratory Medicine (DGKL) proposes a combination of models 2 and 3 to overcome some disadvantages inherent to both models. In the new model, the permissible imprecision is not defined as a constant proportion of biological variation but by a non-linear relationship between permissible analytical and biological variation. Furthermore, the permissible imprecision is referred to the target quantity value. The biological variation is derived from the reference interval, if appropriate, after logarithmic transformation of the reference limits.

scholarly journals Performance criteria and quality indicators for the post-analytical phase

2016 ◽  
Vol 54 (7) ◽  
Author(s):  
Laura Sciacovelli ◽  
Ada Aita ◽  
Andrea Padoan ◽  
Michela Pelloso ◽  
Giorgia Antonelli ◽  
...  
Keyword(s):  
Quality Indicators ◽  
State Of The Art ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
The State ◽  
Performance Criteria ◽  
Quality Improvement Strategy ◽  
Laboratory Errors ◽  
Analytical Phase ◽  
Over Time

AbstractQuality indicators (QIs) used as performance measurements are an effective tool in accurately estimating quality, identifying problems that may need to be addressed, and monitoring the processes over time. In Laboratory Medicine, QIs should cover all steps of the testing process, as error studies have confirmed that most errors occur in the pre- and post-analytical phase of testing. Aim of the present study is to provide preliminary results on QIs and related performance criteria in the post-analytical phase.This work was conducted according to a previously described study design based on the voluntary participation of clinical laboratories in the project on QIs of the Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).Overall, data collected highlighted an improvement or stability in performances over time for all reported indicators thus demonstrating that the use of QIs is effective in the quality improvement strategy. Moreover, QIs data are an important source for defining the state-of-the-art concerning the error rate in the total testing process. The definition of performance specifications based on the state-of-the-art, as suggested by consensus documents, is a valuable benchmark point in evaluating the performance of each laboratory.Laboratory tests play a relevant role in the monitoring and evaluation of the efficacy of patient outcome thus assisting clinicians in decision-making. Laboratory performance evaluation is therefore crucial to providing patients with safe, effective and efficient care.

scholarly journals Performance Criteria for Testosterone Measurements Based on Biological Variation in Adult Males: Recommendations from the Partnership for the Accurate Testing of Hormones

2012 ◽  
Vol 58 (12) ◽  
pp. 1703-1710 ◽  
Author(s):  
Yeo-Min Yun ◽  
Julianne Cook Botelho ◽  
Donald W Chandler ◽  
Alex Katayev ◽  
William L Roberts ◽  
...  
Keyword(s):  
Total Error ◽  
Full Range ◽  
Biological Variation ◽  
Analytical Performance ◽  
Performance Criteria ◽  
Performance Goals ◽  
Adult Males ◽  
Large Variability ◽  
Wide Range ◽  
Variation Data

BACKGROUND Testosterone measurements that are accurate, reliable, and comparable across methodologies are crucial to improving public health. Current US Food and Drug Administration–cleared testosterone assays have important limitations. We sought to develop assay performance requirements on the basis of biological variation that allow physiologic changes to be distinguished from assay analytical errors. METHODS From literature review, the technical advisory subcommittee of the Partnership for the Accurate Testing of Hormones compiled a database of articles regarding analytical and biological variability of testosterone. These data, mostly from direct immunoassay-based methodologies, were used to specify analytical performance goals derived from within- and between-person variability of testosterone. RESULTS The allowable limits of desirable imprecision and bias on the basis of currently available biological variation data were 5.3% and 6.4%, respectively. The total error goal was 16.7%. From recent College of American Pathologists proficiency survey data, most currently available testosterone assays missed these analytical performance goals by wide margins. Data from the recently established CDC Hormone Standardization program showed that although the overall mean bias of selected certified assays was within 6.4%, individual sample measurements could show large variability in terms of precision, bias, and total error. CONCLUSIONS Because accurate measurement of testosterone across a wide range of concentrations [approximately 2–2000 ng/dL (0.069–69.4 nmol/L)] is important, we recommend using available data on biological variation to calculate performance criteria across the full range of expected values. Additional studies should be conducted to obtain biological variation data on testosterone from women and children, and revisions should be made to the analytical goals for these patient populations.

Laboratory evaluation of the Du Pont "Dimension Clinical Chemistry System".

1988 ◽  
Vol 34 (9) ◽  
pp. 1899-1903 ◽  
Author(s):  
D Knight ◽  
R Singer ◽  
J M White ◽  
C G Fraser
Keyword(s):  
High Risk ◽  
State Of The Art ◽  
Clinical Chemistry ◽  
Biological Variation ◽  
Analytical Performance ◽  
Laboratory Evaluation ◽  
Laboratory Staff ◽  
Safety Requirements ◽  
Analytical Goals

Abstract We evaluated the analytical performance of the Du Pont Dimension Clinical Chemistry System to assess its suitability as a replacement for the Du Pont aca III, currently routinely used for analysis of pediatric, high-risk, and emergency specimens. Twenty-six analyses were studied. These generally fulfilled pre-set analytical goals for precision based on biological variation or "state of the art." Significant economies were achieved and we found the Dimension to be reliable, easy to operate, and simple to maintain. It also fulfilled safety requirements for analysis of specimens of high risk to laboratory staff.

Permissible limits for uncertainty of measurement in laboratory medicine

2015 ◽  
Vol 53 (8) ◽  
Author(s):  
Rainer Haeckel ◽  
Werner Wosniok ◽  
Ebrhard Gurr ◽  
Burkhard Peil
Keyword(s):  
Linear Relationship ◽  
State Of The Art ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
The State ◽  
Suggested Approach ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Uncertainty Model ◽  
Analytical Variation

AbstractThe international standard ISO 15189 requires that medical laboratories estimate the uncertainty of their quantitative test results obtained from patients’ specimens. The standard does not provide details how and within which limits the measurement uncertainty should be determined. The most common concept for establishing permissible uncertainty limits is to relate them on biological variation defining the rate of false positive results or to base the limits on the state-of-the-art. The state-of-the-art is usually derived from data provided by a group of selected medical laboratories. The approach on biological variation should be preferred because of its transparency and scientific base. Hitherto, all recommendations were based on a linear relationship between biological and analytical variation leading to limits which are sometimes too stringent or too permissive for routine testing in laboratory medicine. In contrast, the present proposal is based on a non-linear relationship between biological and analytical variation leading to more realistic limits. The proposed algorithms can be applied to all measurands and consider any quantity to be assured. The suggested approach tries to provide the above mentioned details and is a compromise between the biological variation concept, the GUM uncertainty model and the technical state-of-the-art.

scholarly journals Spanish society of laboratory medicine external quality assurance programmes: evolution of the analytical performance of clinical laboratories over 30 years and comparison with other programmes

2020 ◽  
Vol 1 (2) ◽  
Author(s):  
Carmen Perich ◽  
Carmen Ricós ◽  
Fernando Marqués ◽  
Joana Minchinela ◽  
Angel Salas ◽  
...  
Keyword(s):  
Quality Assurance ◽  
State Of The Art ◽  
Laboratory Medicine ◽  
Analytical Performance ◽  
External Quality Assurance ◽  
Biological Variability ◽  
External Quality ◽  
Spanish Society ◽  
Clinical Laboratories ◽  
Quality Specifications

AbstractThe purpose of this study is to understand the evolution of the analytical performance of the laboratories participating in the Spanish society of laboratory medicine (SEQCML) external quality assurance (EQA) programmes during its 30 years of operation and to compare it with the performance of other EQA programmes to establish whether the results are similar. The results obtained during this period are evaluated by applying the biological variability (BV) and state of the art-derived quality specifications. In addition, the results are compared with those obtained by other EQA programme organisations. It is noted that the laboratories participating in the EQA–SEQCML programmes have improved their performance over 30 years of experience and that the specifications derived from biological variation are achievable. It is difficult to compare EQA programmes, due to lack of accessibility and the differences in the design of these programmes (control materials, calculations used and analytical specifications established). The data from this study show that for some biological magnitudes the results obtained by the programmes are not yet harmonised, although efforts are being made to achieve this. Organisers of EQA programmes should also join the harmonisation effort by providing information on their results to enable comparison.

scholarly journals An overview of EFLM harmonization activities in Europe

2018 ◽  
Vol 56 (10) ◽  
pp. 1591-1597 ◽  
Author(s):  
Eric S. Kilpatrick ◽  
Sverre Sandberg
Keyword(s):  
Best Practice ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
European Federation ◽  
Eu Countries ◽  
European Guidelines ◽  
Common Basis ◽  
Evaluation Procedures ◽  
E Learning

Abstract The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has initiated many harmonization activities in all phases of the examination process. The EFLM is dealing with both the scientific and the educational aspects of harmonization, with the intention of disseminating best practice in laboratory medicine throughout Europe. Priorities have been given (1) to establish a standard for conducting and assessing biological variation studies and to construct an evidence based EFLM webpage on biological variation data, (2) to harmonize preanalytical procedures by producing European guidelines, (3) to improve test ordering and interpretation, (4) to produce other common European guidelines for laboratory medicine and play an active part in development of clinical guidelines, (5) to establish a common basis for communicating laboratory results to patients, (6) to harmonize units of measurement throughout Europe, (7) to harmonize preanalytical procedures in molecular diagnostics and (8) to harmonize and optimize test evaluation procedures. The EFLM is also now launching the 5th version of the European Syllabus to help the education of European Specialists in Laboratory Medicine (EuSpLM), which is being supported by the development of e-learning courses. A register of EuSpLM is already established for members of National Societies in EU countries, and a similar register will be established for specialists in non-EU countries.

scholarly journals Personalized Reference Intervals in Laboratory Medicine: A New Model Based on Within-Subject Biological Variation

2020 ◽  
Author(s):  
Abdurrahman Coşkun ◽  
Sverre Sandberg ◽  
Ibrahim Unsal ◽  
Coskun Cavusoglu ◽  
Mustafa Serteser ◽  
...  
Keyword(s):  
Steady State ◽  
Personalized Medicine ◽  
Clinical Chemistry ◽  
Reference Interval ◽  
Reference Intervals ◽  
Biological Variation ◽  
Test Results ◽  
Steady State Condition ◽  
Laboratory Test Results ◽  
Measurement Results

Abstract Background The concept of personalized medicine has received widespread attention in the last decade. However, personalized medicine depends on correct diagnosis and monitoring of patients, for which personalized reference intervals for laboratory tests may be beneficial. In this study, we propose a simple model to generate personalized reference intervals based on historical, previously analyzed results, and data on analytical and within-subject biological variation. Methods A model using estimates of analytical and within-subject biological variation and previous test results was developed. We modeled the effect of adding an increasing number of measurement results on the estimation of the personal reference interval. We then used laboratory test results from 784 adult patients (>18 years) considered to be in a steady-state condition to calculate personalized reference intervals for 27 commonly requested clinical chemistry and hematology measurands. Results Increasing the number of measurements had little impact on the total variation around the true homeostatic set point and using ≥3 previous measurement results delivered robust personalized reference intervals. The personalized reference intervals of the study participants were different from one another and, as expected, located within the common reference interval. However, in general they made up only a small proportion of the population-based reference interval. Conclusions Our study shows that, if using results from patients in steady state, only a few previous test results and reliable estimates of within-subject biological variation are required to calculate personalized reference intervals. This may be highly valuable for diagnosing patients as well as for follow-up and treatment.

scholarly journals Evaluation of the clinical chemistry tests analytical performance by using different models and specifications

2019 ◽  
Vol 45 (1) ◽  
pp. 11-18
Author(s):  
Murat Keleş
Keyword(s):  
Quality Management ◽  
Measurement Uncertainty ◽  
Goal Setting ◽  
Clinical Chemistry ◽  
Biological Variation ◽  
Analytical Performance ◽  
Analytical Quality ◽  
Analytical Error ◽  
Circular Letter ◽  
Clinical Chemistry Tests

Abstract Background The importance of managing analytical quality in clinical laboratories is known. Goal-setting models are critical for analytical quality management, along with correctly implemented error models. However, the methods used to determine analytical performance and more importantly, the relevant analytical quality goals are open to discussion. Our aim was to compare the analytical performance characteristics of routine clinical chemistry tests with different goal-setting models which was proposed by various establishments. In addition, to provide a perspective to Turkish total analytical error (TAE) circular letter that compulsory to calculate from 2016. Materials and methods This study was performed by the data obtained from the internal and external quality control of clinical chemistry tests which were measured by Roche Cobas c501 biochemistry analyzer. TAE calculated with TAE% = 1.65 ×(CV%) + Bias% formula. Nordtest uncertainty model was used in the calculation of measurement uncertainty (MU). In this context, total analytical error was evaluated with biological variation (BV), RCPA, CLIA and Turkish allowable total error (ATE) goals. Measurement uncertainty was evaluated with only permissible measurement uncertainty (pU%) goal. Results In our study, RCPA goals are the most stringent, followed by the BVEuBIVAS, BVRicos, pU%, CLIA and finally the ATETurkey goals coming in last. In cumulatively, BVEuBIVAS goals were 18.3% lower than BVRicos for evaluated parameters. Conclusion The balance between applicability and analytical assurance of goals should be well ensured when determining goal-setting models. Circular letter (2016/18) creates awareness to the analytical quality management but still open to development. Biological variation dependent total allowable error model never designed to be used as benchmarks for measurement uncertainty and it is not methodologically appropriate for assessing measurement uncertainty which was estimated by the Nordtest method. Also considered that, the use of “permissible MU” is more methodologically appropriate in the evaluation of measurement uncertainty.

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