scholarly journals Interferograms plotted with reference change value (RCV) may facilitate the management of hemolyzed samples

2021 ◽  
Author(s):  
Kamil Taha Uçar ◽  
Abdulkadir Çat ◽  
Alper Gümüş ◽  
Nilhan Nurlu
Keyword(s):  
Linear Regression ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
The Other ◽  
Mechanical Trauma ◽  
European Federation ◽  
Evidence Based ◽  
Reference Change Value ◽  
Preanalytical Phase ◽  
Sensitive Parameters

Background: The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE) have recommended an algorithm based on the reference change value (RCV) to evaluate hemolysis. We utilized this algorithm to analyze hemolysis-sensitive parameters. Methods: Two tubes of blood were collected from each of the 10 participants, one of which was subjected to mechanical trauma while the other was centrifuged directly. Subsequently, the samples were diluted with the participant's hemolyzed sample to obtain the desired hemoglobin concentrations (0, 1, 2, 4, 6, 8, and 10 g/L). ALT, AST, K, LDH, T.Bil tests were performed using Beckman Coulter AU680 analyzer. The analytical and clinical cut-offs were based on the biological variation for the allowable imprecision and RCV. The algorithms could report the values directly below the analytical cut-off or those between the analytical and clinical cut-offs with comments. If the change was above the clinical cut-off, the test was rejected. The linear regression was used for interferograms, and the hemoglobin concentrations corresponding to cut-offs were calculated via the interferograms. Results: The RCV was calculated as 29.6% for ALT. Therefore, ALT should be rejected in samples containing >5.9 g/L hemoglobin. The RCVs for AST, K, LDH, and T.Bil were calculated as 27.9%, 12.1%, 19.2%, and 61.2%, while the samples' hemoglobin concentrations for test rejection were 0.8, 1.6, 0.5, and 2.2 g/L, respectively. Conclusions: Algorithms prepared with RCV could provide evidence-based results and objectively manage hemolyzed samples.

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.

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.

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.

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