How to assess the quality of your analytical method?

2015 ◽  
Vol 53 (11) ◽  
Author(s):  
Elizabeta Topic ◽  
Nora Nikolac ◽  
Mauro Panteghini ◽  
Elvar Theodorsson ◽  
Gian Luca Salvagno ◽  
...  
Keyword(s):  
Limit Of Detection ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Internal Quality ◽  
European Federation ◽  
Blood Collection ◽  
Test Procedures ◽  
High Quality ◽  
Laboratory Errors

AbstractLaboratory medicine is amongst the fastest growing fields in medicine, crucial in diagnosis, support of prevention and in the monitoring of disease for individual patients and for the evaluation of treatment for populations of patients. Therefore, high quality and safety in laboratory testing has a prominent role in high-quality healthcare. Applied knowledge and competencies of professionals in laboratory medicine increases the clinical value of laboratory results by decreasing laboratory errors, increasing appropriate utilization of tests, and increasing cost effectiveness. This collective paper provides insights into how to validate the laboratory assays and assess the quality of methods. It is a synopsis of the lectures at the 15th European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Continuing Postgraduate Course in Clinical Chemistry and Laboratory Medicine entitled “How to assess the quality of your method?” (Zagreb, Croatia, 24–25 October 2015). The leading topics to be discussed include who, what and when to do in validation/verification of methods, verification of imprecision and bias, verification of reference intervals, verification of qualitative test procedures, verification of blood collection systems, comparability of results among methods and analytical systems, limit of detection, limit of quantification and limit of decision, how to assess the measurement uncertainty, the optimal use of Internal Quality Control and External Quality Assessment data, Six Sigma metrics, performance specifications, as well as biological variation. This article, which continues the annual tradition of collective papers from the EFLM continuing postgraduate courses in clinical chemistry and laboratory medicine, aims to provide further contributions by discussing the quality of laboratory methods and measurements and, at the same time, to offer continuing professional development to the attendees.

Sample collections from healthy volunteers for biological variation estimates’ update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine

2016 ◽  
Vol 54 (10) ◽  
Author(s):  
Anna Carobene ◽  
Marta Strollo ◽  
Niels Jonker ◽  
Gerhard Barla ◽  
William A. Bartlett ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
European Federation ◽  
Laboratory Measurements ◽  
Controlled Conditions ◽  
Edta Plasma ◽  
Blood Specimens

AbstractBackground:Biological variation (BV) data have many fundamental applications in laboratory medicine. At the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) the reliability and limitations of current BV data were discussed. The EFLM Working Group on Biological Variation is working to increase the quality of BV data by developing a European project to establish a biobank of samples from healthy subjects to be used to produce high quality BV data.Methods:The project involved six European laboratories (Milan, Italy; Bergen, Norway; Madrid, Spain; Padua, Italy; Istanbul, Turkey; Assen, The Netherlands). Blood samples were collected from 97 volunteers (44 men, aged 20–60 years; 43 women, aged 20–50 years; 10 women, aged 55–69 years). Initial subject inclusion required that participants completed an enrolment questionnaire to verify their health status. The volunteers provided blood specimens once per week for 10 weeks. A short questionnaire was completed and some laboratory tests were performed at each sampling consisting of blood collected under controlled conditions to provide serum, KResults:Samples from six out of the 97 enroled subjects were discarded as a consequence of abnormal laboratory measurements. A biobank of 18,000 aliquots was established consisting of 120 aliquots of serum, 40 of EDTA-plasma, and 40 of citrated-plasma from each subject. The samples were stored at –80 °C.Conclusions:A biobank of well-characterised samples collected under controlled conditions has been established delivering a European resource to enable production of contemporary BV data.

scholarly journals Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

2017 ◽  
Vol 55 (12) ◽  
Author(s):  
Mauro Panteghini ◽  
Ferruccio Ceriotti ◽  
Graham Jones ◽  
Wytze Oosterhuis ◽  
Mario Plebani ◽  
...  
Keyword(s):  
Measurement Errors ◽  
Clinical Chemistry ◽  
Total Error ◽  
Laboratory Medicine ◽  
European Federation ◽  
Quality Of Data ◽  
Performance Specifications ◽  
Fit For Purpose ◽  
Set Up

AbstractMeasurements in clinical laboratories produce results needed in the diagnosis and monitoring of patients. These results are always characterized by some uncertainty. What quality is needed and what measurement errors can be tolerated without jeopardizing patient safety should therefore be defined and specified for each analyte having clinical use. When these specifications are defined, the total examination process will be “fit for purpose” and the laboratory professionals should then set up rules to control the measuring systems to ensure they perform within specifications. The laboratory community has used different models to set performance specifications (PS). Recently, it was felt that there was a need to revisit different models and, at the same time, to emphasize the presuppositions for using the different models. Therefore, in 2014 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) organized a Strategic Conference in Milan. It was felt that there was a need for more detailed discussions on, for instance, PS for EQAS, which measurands should use which models to set PS and how to set PS for the extra-analytical phases. There was also a need to critically evaluate the quality of data on biological variation studies and further discussing the use of the total error (TE) concept. Consequently, EFLM established five Task Finish Groups (TFGs) to address each of these topics. The TFGs are finishing their activity on 2017 and the content of this paper includes deliverables from these groups.

Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)

2017 ◽  
Vol 55 (1) ◽  
pp. 27-31 ◽  
Author(s):  
Michael Cornes ◽  
Edmée van Dongen-Lases ◽  
Kjell Grankvist ◽  
Mercedes Ibarz ◽  
Gunn Kristensen ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Venous Blood ◽  
Laboratory Medicine ◽  
European Federation ◽  
Blood Collection ◽  
Sample Collection ◽  
Blood Draw ◽  
Preanalytical Phase ◽  
Analytical Phase

AbstractIt has been well reported over recent years that most errors within the total testing process occur in the pre-analytical phase (46%–68.2%), an area that is usually outside of the direct control of the laboratory and which includes sample collection (phlebotomy). National and international (WHO, CLSI) guidelines recommend that the order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes that could cause erroneous results. There have been a number of studies recently looking at whether order of draw remains a problem with modern phlebotomy techniques and materials, or it is an outdated practice followed simply because of historical reasons. In the following article, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) provides an overview and summary of the literature with regards to order of draw in venous blood collection. Given the evidence presented in this article, the EFLM WG-PRE herein concludes that a significant frequency of sample contamination does occur if order of draw is not followed during blood collection and when performing venipuncture under less than ideal circumstances, thus putting patient safety at risk. Moreover, given that order of draw is not difficult to follow and knowing that ideal phlebotomy conditions and protocols are not always followed or possible, EFLM WG-PRE supports the continued recommendation of ensuring a correct order of draw for venous blood collection.

scholarly journals EFLM WG-Preanalytical phase opinion paper: local validation of blood collection tubes in clinical laboratories

2016 ◽  
Vol 54 (5) ◽  
Author(s):  
Giuseppe Lippi ◽  
Michael P. Cornes ◽  
Kjell Grankvist ◽  
Mads Nybo ◽  
Ana-Maria Simundic
Keyword(s):  
Clinical Chemistry ◽  
European Federation ◽  
Blood Collection ◽  
Healthcare Facilities ◽  
Hospital Administrators ◽  
Consensus Document ◽  
Preanalytical Phase ◽  
Blood Collection Tubes ◽  
Validation Experiments

AbstractThe selection or procurement of blood collection devices in healthcare facilities is often an underestimated issue. This is probably due to different factors including the lack of knowledge of policymakers, hospital administrators and even laboratory managers about the importance of preanalytical quality and phlebotomy process, as well as to the absence of reliable guidelines or recommendations on how to precisely assess the quality of blood collection devices around the globe. With the awareness that a gap remains between manufacturers’ and local validation of blood collection devices, the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has drafted a consensus document aimed to provide a set of essential requisites, technical criteria (e.g. presence of physical defects, malfunctioning, safety problems) and clinical issues for supporting laboratory professionals in organization blood collection tubes tenders and validating new devices before local routine implementation. The laboratory professionals should also make sure that the tenders accurately and strictly define the responsibilities for validation experiments and the potential consequences in the case the validation outcome shows that tubes due not fulfill the expectations.

Exact time of venous blood sample collection – an unresolved issue, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)

2020 ◽  
Vol 58 (10) ◽  
pp. 1655-1662
Author(s):  
Alexander von Meyer ◽  
Giuseppe Lippi ◽  
Ana-Maria Simundic ◽  
Janne Cadamuro
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Venous Blood ◽  
Laboratory Medicine ◽  
Sampling Time ◽  
European Federation ◽  
Blood Collection ◽  
Sample Collection ◽  
Pilot Survey ◽  
Preanalytical Phase

AbstractObjectivesAn accurate knowledge of blood collection times is crucial for verifying the stability of laboratory analytes. We therefore aimed to (i) assess if and how this information is collected throughout Europe and (ii) provide a list of potentially available solutions.MethodsA survey was issued by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group on Preanalytical Phase (WG-PRE) in 2017, aiming to collect data on preanalytical process management, including sampling time documentation, in European laboratories. A preceding pilot survey was disseminated in Austria in 2016. Additionally, preanalytical experts were surveyed on their local setting on this topic. Finally, the current scientific literature was reviewed on established possibilities of sampling time collection.ResultsA total number of 85 responses was collected from the pilot survey, whilst 1347 responses from 37 European countries were obtained from the final survey. A minority (i.e. ~13%) of responders to the latter declared they are unaware of the exact sampling time. The corresponding rate in Austria was ~70% in the pilot and ~30% in the final survey, respectively. Answers from 17 preanalytical experts from 16 countries revealed that sampling time collection seems to be better documented for out- than for in-patients. Eight different solutions for sample time documentation are presented.ConclusionsThe sample collection time seems to be documented very heterogeneously across Europe, or not at all. Here we provide some solutions to this issue and believe that laboratories should urgently aim to implement one of these.

scholarly journals Harmonization initiatives in the generation, reporting and application of biological variation data

2018 ◽  
Vol 56 (10) ◽  
pp. 1629-1636 ◽  
Author(s):  
Aasne K. Aarsand ◽  
Thomas Røraas ◽  
William A. Bartlett ◽  
Abdurrahman Coşkun ◽  
Anna Carobene ◽  
...  
Keyword(s):  
Critical Appraisal ◽  
Clinical Chemistry ◽  
Meta Analysis ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
Quality Data ◽  
European Federation ◽  
High Quality ◽  
Wide Range ◽  
Variation Data

Abstract Biological variation (BV) data have many applications in laboratory medicine. However, concern has been raised that some BV estimates in use today may be irrelevant or of unacceptable quality. A number of initiatives have been launched by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and other parties to deliver a more harmonized practice in the generation, reporting and application of BV data. Resulting from a necessary focus upon the veracity of historical BV studies, critical appraisal and meta-analysis of published BV studies is possible through application of the Biological Variation Data Critical Appraisal Checklist (BIVAC), published in 2017. The BIVAC compliant large-scale European Biological Variation Study delivers updated high-quality BV data for a wide range of measurands. Other significant developments include the publication of a Medical Subject Heading term for BV and recommendations for common terminology for reporting of BV data. In the near future, global BV estimates derived from meta-analysis of BIVAC appraised publications will be accessible in a Biological Variation Database at the EFLM website. The availability of these high-quality data, which have many applications that impact on the quality and interpretation of clinical laboratory results, will afford improved patient care.

Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)

2015 ◽  
Vol 53 (8) ◽  
Author(s):  
Marc H.M. Thelen ◽  
Florent J.L.A. Vanstapel ◽  
Christos Kroupis ◽  
Ines Vukasovic ◽  
Guilaime Boursier ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Position Paper ◽  
European Federation ◽  
Medical Field ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Flexible Scope ◽  
Scientific Disciplines

AbstractThe recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accreditation (EA) demands that the national bodies responsible for accreditation describe the scope of every laboratory accreditation in a way that leaves no room for doubt about the range of competence of the particular laboratories. According to EA recommendations scopes may be fixed, mentioning every single test that is part of the accreditation, or flexible, mentioning all combinations of medical field, examination type and materials for which the laboratory is competent. Up to now national accreditation bodies perpetuate use of fixed scopes, partly by inertia, partly out of fear that a too flexible scope may lead to over-valuation of the competence of laboratories, most countries only use fixed scopes. The EA however promotes use of flexible scopes, since this allows for more readily innovation, which contributes to quality in laboratory medicine. In this position paper, the Working Group Accreditation and ISO/CEN Standards belonging to the Quality and Regulation Committee of the EFLM recommends using an approach that has led to successful introduction of the flexible scope for ISO15189 accreditation as intended in EA-4/17 in The Netherlands. The approach is risk-based, discipline and competence-based, and focuses on defining a uniform terminology transferable across the borders of scientific disciplines, laboratories and countries.

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 Commutability of reference and control materials: an essential factor for assuring the quality of measurements in Laboratory Medicine

2019 ◽  
Vol 57 (7) ◽  
pp. 967-973 ◽  
Author(s):  
Federica Braga ◽  
Mauro Panteghini
Keyword(s):  
External Quality Assessment ◽  
Prediction Interval ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Clinical Samples ◽  
Essential Factor ◽  
Common Reference ◽  
And Control ◽  
Selection Of

Abstract Traceability to a common reference ensures equivalence of results obtained by different assays. Traceability is achieved by an unbroken sequence of calibrations, using reference materials (RMs) that must be commutable. Using non-commutable RMs for calibration will introduce a bias in the calibrated method producing incorrect results for clinical samples (CS). Commutability was defined in 1973 as “the ability of an enzyme material to show inter-assay activity changes comparable to those of the same enzyme in human serum” and later extended as a characteristic of all RMs. However, the concept is still poorly understood and appreciated. Commutability assessment has been covered in CLSI guidelines and requires: (a) selection of 20 CS spanning the relevant concentration range; (b) analysis of both RM and CS with the pair of procedures; (c) data elaboration using regression analysis and calculation if RM fall within the 95% prediction interval defined by CS. This approach has been criticized and to improve it The International Federation of Clinical Chemistry and Laboratory Medicine established a working group that recently finalized recommendations. Commutability is also a requirement for the applicability of external quality assessment (EQA) results in the evaluation of the performance of participating laboratories in terms of standardization of their measurements. Unfortunately, EQA materials are usually not validated for commutability.

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