The EFLM strategy for harmonization of the preanalytical phase

2018 ◽  
Vol 56 (10) ◽  
pp. 1660-1666 ◽  
Author(s):  
Giuseppe Lippi ◽  
Ana-Maria Simundic ◽  
Keyword(s):  
Clinical Chemistry ◽  
European Federation ◽  
Blood Collection ◽  
External Quality Assessment Scheme ◽  
Preanalytical Phase ◽  
Unsuitable Samples ◽  
Definition Of ◽  
Sampling Procedures ◽  
Development And Validation ◽  
Blood Collection Tubes

Abstract The Working Group for the Preanalytical Phase (WG-PRE) was officially established by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in 2013, with the aim of improving harmonization in the preanalytical phase across European member societies. Since its early birth, the WG-PRE has already completed a number of projects, including harmonizing the definition of fasting status, patient and blood tubes identification, color coding of blood collection tubes, sequence of tubes during blood drawing and participation in the development of suitable preanalytical quality indicators. The WG-PRE has also provided guidance on local validation of blood collection tubes, has performed two European surveys on blood sampling procedures and has organized four European meetings to promote the importance of quality in the preanalytical phase. The future activities entail development and validation of an external quality assessment scheme focused on preanalytical variables, development and dissemination of a survey about the local management of unsuitable samples in clinical laboratories, as well as release of EFLM phlebotomy guidelines. This article summarizes all recent achievements of the WG-PRE and illustrates future projects to promote harmonization in the preanalytical phase.

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.

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.

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 Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE)

2015 ◽  
Vol 53 (3) ◽  
Author(s):  
Giuseppe Lippi ◽  
Giuseppe Banfi ◽  
Stephen Church ◽  
Michael Cornes ◽  
Gabriella De Carli ◽  
...  
Keyword(s):  
Quality Improvement ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
European Federation ◽  
Laboratory Diagnostics ◽  
The European Union ◽  
Becton Dickinson ◽  
External Quality Assessment Scheme ◽  
Eu Directive ◽  
Preanalytical Phase

AbstractLaboratory diagnostics develop through different phases that span from test ordering (pre-preanalytical phase), collection of diagnostic specimens (preanalytical phase), sample analysis (analytical phase), results reporting (postanalytical phase) and interpretation (post-postanalytical phase). Although laboratory medicine seems less vulnerable than other clinical and diagnostic areas, the chance of errors is not negligible and may adversely impact on quality of testing and patient safety. This article, which continues a biennial tradition of collective papers on preanalytical quality improvement, is aimed to provide further contributions for pursuing quality and harmony in the preanalytical phase, and is a synopsis of lectures of the third European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)-Becton Dickinson (BD) European Conference on Preanalytical Phase meeting entitled ‘Preanalytical quality improvement. In pursuit of harmony’ (Porto, 20–21 March 2015). The leading topics that will be discussed include unnecessary laboratory testing, management of test request, implementation of the European Union (EU) Directive on needlestick injury prevention, harmonization of fasting requirements for blood sampling, influence of physical activity and medical contrast media on in vitro diagnostic testing, recent evidence about the possible lack of necessity of the order of draw, the best practice for monitoring conditions of time and temperature during sample transportation, along with description of problems emerging from inappropriate sample centrifugation. In the final part, the article includes recent updates about preanalytical quality indicators, the feasibility of an External Quality Assessment Scheme (EQAS) for the preanalytical phase, the results of the 2nd EFLM WG-PRE survey, as well as specific notions about the evidence-based quality management of the preanalytical phase.

Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE)

2015 ◽  
Vol 53 (9) ◽  
Author(s):  
Ana-Maria Simundic ◽  
Stephen Church ◽  
Michael P. Cornes ◽  
Kjell Grankvist ◽  
Giuseppe Lippi ◽  
...  
Keyword(s):  
Observational Study ◽  
Working Group ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Test Tube ◽  
European Countries ◽  
European Federation ◽  
Patient Identification ◽  
Preanalytical Phase ◽  
Sampling Procedures

AbstractAn observational study was conducted in 12 European countries by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) to assess the level of compliance with the CLSI H3-A6 guidelines.A structured checklist including 29 items was created to assess the compliance of European phlebotomy procedures with the CLSI H3-A6 guideline. A risk occurrence chart of individual phlebotomy steps was created from the observed error frequency and severity of harm of each guideline key issue. The severity of errors occurring during phlebotomy was graded using the risk occurrence chart.Twelve European countries participated with a median of 33 (18–36) audits per country, and a total of 336 audits. The median error rate for the total phlebotomy procedure was 26.9 % (10.6–43.8), indicating a low overall compliance with the recommended CLSI guideline. Patient identification and test tube labelling were identified as the key guideline issues with the highest combination of probability and potential risk of harm. Administrative staff did not adhere to patient identification procedures during phlebotomy, whereas physicians did not adhere to test tube labelling policy.The level of compliance of phlebotomy procedures with the CLSI H3-A6 guidelines in 12 European countries was found to be unacceptably low. The most critical steps in need of immediate attention in the investigated countries are patient identification and tube labelling.

scholarly journals Characteristics of a novel NMR-based metabolomics platform for dogs

2019 ◽  
Author(s):  
Claudia Ottka ◽  
Katariina Vapalahti ◽  
Jenni Puurunen ◽  
Laura Vahtera ◽  
Hannes Lohi
Keyword(s):  
Quantitative Methods ◽  
Method Comparison ◽  
Well Being ◽  
Reference Intervals ◽  
Blood Collection ◽  
Prolonged Contact ◽  
Quantitative Results ◽  
Quantitative Nuclear Magnetic Resonance ◽  
Development And Validation ◽  
Blood Collection Tubes

AbstractMetabolomics has proven itself an invaluable research tool, providing comprehensive insight to systemic metabolism. However, the lack of scalable and quantitative methods with known reference intervals and documented reproducibility has prevented the use of metabolomics in the clinical setting. This study describes the development and validation of a quantitative nuclear magnetic resonance (NMR) -based metabolomics platform for canine serum and plasma samples. Altogether 8247 canine samples were analyzed using a Bruker’s 500 MHz NMR spectrometer. Using statistical approaches derived from international guidelines, we defined reference intervals for 123 biomarkers, studied method precision, analyte storage stability, the effect of prolonged contact to red blood cells, differences of blood collection tubes, interference of lipemia, hemolysis and bilirubinemia, method comparison, and demonstrated the method’s practical relevance in a hyperglycemic cohort. Owing to the advantages of quantitative results, high reproducibility, and scalability, this canine metabolomics platform holds great potential for numerous clinical and research applications to improve canine health and well-being.

scholarly journals European survey on preanalytical sample handling – Part 1: How do European laboratories monitor the preanalytical phase? On behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Pha

2019 ◽  
Vol 29 (2) ◽  
pp. 322-333 ◽  
Author(s):  
Janne Cadamuro ◽  
Michael Cornes ◽  
Ana-Maria Simundic ◽  
Barbara de la Salle ◽  
Gunn B.B. Kristensen ◽  
...  
Keyword(s):  
Online Survey ◽  
Clinical Chemistry ◽  
European Federation ◽  
Preanalytical Phase ◽  
Critical Issues ◽  
Learning Programs ◽  
E Learning ◽  
New Guidelines ◽  
Measurement And Evaluation ◽  
Guidelines And Recommendations

Introduction: Compared to other activities of the testing process, the preanalytical phase is plagued by a lower degree of standardization, which makes it more vulnerable to errors. With the aim of providing guidelines and recommendations, the EFLM WG-PRE issued a survey across European medical laboratories, to gather information on local preanalytical practices. This is part one of two coherent articles, which covers all practices on monitoring preanalytical quality except haemolysis, icterus and lipemia (HIL). Materials and methods: An online survey, containing 39 questions dealing with a broad spectrum of preanalytical issues, was disseminated to EFLM member countries. The survey included questions on willingness of laboratories to engage in preanalytical issues. Results: Overall, 1405 valid responses were received from 37 countries. 1265 (94%) responders declared to monitor preanalytical errors. Assessment, documentation and further use of this information varied widely among respondents and partially among countries. Many responders were interested in a preanalytical online platform, holding information on various aspects of the preanalytical phase (N = 1177; 87%), in a guideline for measurement and evaluation of preanalytical variables (N = 1235; 92%), and in preanalytical e-learning programs or webinars (N = 1125; 84%). Fewer responders were interested in, or already participating in, preanalytical EQA programs (N = 951; 71%). Conclusion: Although substantial heterogeneity was found across European laboratories on preanalytical phase monitoring, the interest in preanalytical issues was high. A large majority of participants indicated an interest in new guidelines regarding preanalytical variables and learning activities. This important data will be used by the WG-PRE for providing recommendations on the most critical issues.

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.

Comparative Evaluation of Blood Collection Tubes for Clinical Chemistry Analysis

2021 ◽  
Author(s):  
Nadia Ayala-Lopez ◽  
Steven E. Conklin data analysis ◽  
Brandon J. Tenney ◽  
Maryann Ness ◽  
Mark A. Marzinke
Keyword(s):  
Comparative Evaluation ◽  
Clinical Chemistry ◽  
Blood Collection ◽  
Blood Collection Tubes
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