scholarly journals The CRESS checklist for reporting stability studies: on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)

2021 ◽  
Vol 59 (1) ◽  
pp. 59-69
Author(s):  
Michael Cornes ◽  
Ana-Maria Simundic ◽  
Janne Cadamuro ◽  
Seán J. Costelloe ◽  
Geoffrey Baird ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Stability Study ◽  
European Federation ◽  
Published Data ◽  
Stability Studies ◽  
Essential Information ◽  
Preanalytical Phase ◽  
The Stability

AbstractTo ensure that clinical laboratories produce results that are both accurate and of clinical utility it is essential that only samples of adequate quality are analysed. Although various studies and databases assessing the stability of analytes in different settings do exist, guidance on how to perform and report stability studies is lacking. This results in studies that often do not report essential information, thus compromising transferability of the data. The aim of this manuscript is to describe the Checklist for Reporting Stability Studies (CRESS) against which future studies should be reported to ensure standardisation of reporting and easy assessment of transferability of studies to other healthcare settings. The EFLM WG-PRE (European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase) produced the CRESS checklist following a detailed literature review and extensive discussions resulting in consensus agreement. The checklist consists of 20 items covering all the aspects that should be considered when producing a report on a stability study including details of what should be included for each item and a rationale as to why. Adherence to the CRESS checklist will ensure that studies are reported in a transparent and replicable way. This will allow other laboratories to assess whether published data meet the stability criteria required in their own particular healthcare scenario. The EFLM WG-PRE encourage researchers and authors to use the CRESS checklist as a guide to planning stability studies and to produce standardised reporting of future stability studies.

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 Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)

2017 ◽  
Vol 55 (4) ◽  
Author(s):  
Giuseppe Lippi ◽  
Geoffrey S. Baird ◽  
Giuseppe Banfi ◽  
Karin Bölenius ◽  
Janne Cadamuro ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Diagnostic Testing ◽  
Laboratory Medicine ◽  
Therapeutic Monitoring ◽  
European Federation ◽  
Preanalytical Phase ◽  
Total Testing Process ◽  
The Many ◽  
High Degree

Abstract It is now undeniable that laboratory testing is vital for the diagnosis, prognostication and therapeutic monitoring of human disease. Despite the many advances made for achieving a high degree of quality and safety in the analytical part of diagnostic testing, many hurdles in the total testing process remain, especially in the preanalytical phase ranging from test ordering to obtaining and managing the biological specimens. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has planned many activities aimed at mitigating the vulnerability of the preanalytical phase, including the organization of three European meetings in the past 7 years. Hence, this collective article follows the previous three opinion papers that were published by the EFLM WGPRE on the same topic, and brings together the summaries of the presentations that will be given at the 4th EFLM-BD meeting “Improving quality in the preanalytical phase through innovation” in Amsterdam, 24–25 March, 2017.

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.

Wspólne zalecenia EFLM-COLABIOCLI dotyczące pobierania krwi żylnej

2019 ◽  
Vol 54 (4) ◽  
pp. 291-312
Author(s):  
Ana-Maria Simundic ◽  
Karin Bölenius ◽  
Janne Cadamuro ◽  
Stephen Church ◽  
Michael P. Cornes ◽  
...  
Keyword(s):  
Latin America ◽  
Latin American ◽  
Working Group ◽  
Clinical Biochemistry ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
European Federation ◽  
Preanalytical Phase

Niniejszy dokument zawiera zalecenia dotyczące pobierania krwi żylnej, opracowane wspólnie przez European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE) oraz Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin America Confederation of Clinical Biochemistry (COLABIOCLI). Dokument określa wytyczne dotyczące rekomendacji zapewniających bezpieczeństwo procesu pobierania krwi oraz przekazuje informacje praktyczne dotyczące skutecznego pokonywania przeszkód związanych z procesem wdrożenia procedury na szeroką skalę. Grupą docelową zaleceń są pracownicy ochrony zdrowia bezpośrednio zaangażowani w proces pobierania krwi. Zalecenia dotyczą wykorzystania zamkniętych systemów do pobierania krwi i nie znajdują zastosowania w przypadku systemów otwartych, takich jak igła ze strzykawką lub cewnik. Ponadto w dokumencie nie omówiono zagadnień związanych z uzyskaniem zgody pacjenta, zlecaniem oznaczeń, obsługą ani transportem próbki, pobieraniem krwi u dzieci i osób z utratą przytomności. Zalecana procedura powstała w oparciu o dostępne dowody naukowe. Każdy z etapów został zaszeregowany w oparciu o system, w ramach którego ocenia się zarówno jakość materiału naukowego jak i siłę zaleceń. Proces oceny przeprowadzono na drodze wielu konsultacji, w których udział brała wymieniona powyżej grupa interesariuszy. Najważniejsze aspekty niniejszych zaleceń to: 1) procedury przed pobraniem krwi, 2) procedura pobrania krwi, 3) procedury po pobraniu krwi oraz 4) wdrożenie. Wstępną wersję zaleceń przekazano członkom EFLM w ramach konsultacji publicznych. Swoje uwagi do dokumentu wnieśli również członkowie WG-PRE-LATAM. Poprawioną wersję przesłano do głosowania wszystkich członków EFLM i COLABIOCLI. Uzyskała ona poparcie 33/40 członków ELFM i 21/21 członków COLABIOCLI. Zachęcamy specjalistów z Europy i Ameryki Łacińskiej do wdrożenia niniejszych rekomendacji w celu poprawy jakości praktyk związanych z pobieraniem krwi oraz poprawy bezpieczeństwa pacjentów i pracowników ochrony zdrowia.

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.

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.

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