| 1. |
- Cadamuro, Janne, et al.
(författare)
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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 Phase (WG-PRE)
- 2019
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Ingår i: Biochemia Medica. - : Croatian Society of Medical Biochemistry and Laboratory Medicine. - 1330-0962 .- 1846-7482. ; 29:2
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 2. |
- Cadamuro, Janne, et al.
(författare)
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European survey on preanalytical sample handling - Part 2 : Practices of European laboratories on monitoring and processing haemolytic, icteric and lipemic samples. On behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)
- 2019
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Ingår i: Biochemia Medica. - : Croatian Society of Medical Biochemistry and Laboratory Medicine. - 1330-0962 .- 1846-7482. ; 29:2
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: No guideline currently exists on how to detect or document haemolysis, icterus or lipemia (HIL) in blood samples, nor on subsequent use of this information. The EFLM WG-PRE has performed a survey for assessing current practices of European laboratories in HIL monitoring. This second part of two coherent articles is focused on HIL.Materials and methods: An online survey, containing 39 questions on preanalytical issues, was disseminated among EFLM member countries. Seventeen questions exclusively focused on assessment, management and follow-up actions of HIL in routine blood samples.Results: Overall, 1405 valid responses from 37 countries were received. A total of 1160 (86%) of all responders stating to analyse blood samples - monitored HIL. HIL was mostly checked in clinical chemistry samples and less frequently in those received for coagulation, therapeutic drug monitoring and serology/infectious disease testing. HIL detection by automatic HIL indices or visual inspection, along with haemolysis cut-offs definition, varied widely among responders. A quarter of responders performing automated HIL checks used internal quality controls. In haemolytic/icteric/lipemic samples, most responders (70%) only rejected HIL-sensitive parameters, whilst about 20% released all test results with general comments. Other responders did not analysed but rejected the entire sample, while some released all tests, without comments. Overall, 26% responders who monitored HIL were using this information for monitoring phlebotomy or sample transport quality.Conclusion: Strategies for monitoring and treating haemolytic, icteric or lipemic samples are quite heterogeneous in Europe. The WG-PRE will use these insights for developing and providing recommendations aimed at harmonizing strategies across Europe.
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| 3. |
- Cornes, Michael, et al.
(författare)
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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
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Ingår i: Clinical Chemistry and Laboratory Medicine. - : Walter de Gruyter GmbH. - 1434-6621 .- 1437-4331. ; 55:1, s. 27-31
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Tidskriftsartikel (refereegranskat)abstract
- It 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.
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| 4. |
- Cornes, Michael P., et al.
(författare)
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The role of European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase in standardization and harmonization of the preanalytical phase in Europe
- 2016
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Ingår i: Annals of Clinical Biochemistry. - : SAGE Publications. - 0004-5632 .- 1758-1001. ; 53:5, s. 539-547
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Forskningsöversikt (refereegranskat)abstract
- Patient safety is a leading challenge in healthcare and from the laboratory perspective it is now well established that preanalytical errors are the major contributor to the overall rate of diagnostic and therapeutic errors. To address this, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase (EFLM WG-PRE) was established to lead in standardization and harmonization of preanalytical policies and practices at a European level. One of the key activities of the WG-PRE is the organization of the biennial EFLM-BD conference on the preanalytical phase to provide a forum for National Societies (NS) to discuss their issues. Since 2012, a year after the first Preanalytical phase conference, there has been a rapid growth in the number of NS with a working group engaged in preanalytical phase activities and there are now at least 19 countries that have one. As a result of discussions with NS at the third conference held in March 2015 five key areas were identified as requiring harmonisation. These were test ordering, sample transport and storage, patient preparation, sampling procedures and management of unsuitable specimens. The article below summarises the work that has and will be done in these areas. The goal of this initiative is to ensure the EFLM WG-PRE produces work that meets the needs of the European laboratory medicine community. Progress made in the identified areas will be updated at the next preanalytical phase conference and show that we have produced guidance that has enhanced standardisation in the preanalytical phase and improved patient safety throughout Europe.
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| 5. |
- Simundic, Ana-Maria, et al.
(författare)
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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
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Ingår i: Clinical Chemistry and Laboratory Medicine. - : Walter de Gruyter. - 1434-6621 .- 1437-4331. ; 53:9, s. 1321-1331
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Tidskriftsartikel (refereegranskat)abstract
- Background: An 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. Methods: 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. Results: 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. Conclusions: 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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| 6. |
- Simundic, Ana-Maria, et al.
(författare)
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Joint EFLM-COLABIOCLI recommendation for venous blood sampling
- 2018
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Ingår i: Clinical Chemistry and Laboratory Medicine. - Berlin : Walter de Gruyter. - 1434-6621 .- 1437-4331. ; 56:12, s. 2015-2038
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Tidskriftsartikel (refereegranskat)abstract
- This document provides a joint recommendation for venous blood sampling of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE) and Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin America Confederation of Clinical Biochemistry (COLABIOCLI). It offers guidance on the requirements for ensuring that blood collection is a safe and patient-centered procedure and provides practical guidance on how to successfully overcome potential barriers and obstacles to its widespread implementation. The target audience for this recommendation are healthcare staff members directly involved in blood collection. This recommendation applies to the use of a closed blood collection system and does not provide guidance for the blood collection with an open needle and syringe and catheter collections. Moreover, this document neither addresses patient consent, test ordering, sample handling and transport nor collection from children and unconscious patients. The recommended procedure is based on the best available evidence. Each step was graded using a system that scores the quality of the evidence and the strength of the recommendation. The process of grading was done at several face-to-face meetings involving the same mixture of stakeholders stated previously. The main parts of this recommendation are: 1) Pre-sampling procedures, 2) Sampling procedure, 3) Post-sampling procedures and 4) Implementation. A first draft of the recommendation was circulated to EFLM members for public consultation. WG-PRE-LATAM was also invited to comment the document. A revised version has been sent for voting on to all EFLM and COLABIOCLI members and has been officially endorsed by 33/40 EFLM and 21/21 COLABIOCLI members. We encourage professionals throughout Europe and Latin America to adopt and implement this recommendation to improve the quality of blood collection practices and increase patient and workers safety.
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| 7. |
- Simundic, Ana-Maria, et al.
(författare)
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Raccomandazione congiunta EFLM-COLABIOCLI per il prelievo di sangue venoso : [Joint EFLM-COLABIOCLI recommendation for venous blood sampling]
- 2019
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Ingår i: Biochimica Clinica. - 0393-0564 .- 0392-7091. ; 43:2, s. 204-227
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Forskningsöversikt (refereegranskat)abstract
- This document provides a joint recommendation for venous blood sampling of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE) and Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin America Confederation of Clinical Biochemistry (COLABIOCLI). It offers guidance on the requirements for ensuring that blood collection is a safe and patient-centered procedure and provides practical guidance on how to successfully overcome potential barriers and obstacles to its widespread implementation. The target audience for this recommendation are healthcare staff members directly involved in blood collection. This recommendation applies to the use of a closed blood collection system and does not provide guidance for the blood collection with an open needle and syringe and catheter collections. Moreover, this document neither addresses patient consent, test ordering, sample handling and transport nor collection from children and unconscious patients. The recommended procedure is based on the best available evidence. Each step was graded using a system that scores the quality of the evidence and the strength of the recommendation. The process of grading was done at several face-to-face meetings involving the same mixture of stakeholders stated previously. The main parts of this recommendation are: 1) Pre-sampling procedures, 2) Sampling procedure, 3) Postsampling procedures and 4) Implementation. A first draft of the recommendation was circulated to EFLM members for public consultation. WG-PRE-LATAM was also invited to comment the document. A revised version has been sent for voting on to all EFLM and COLABIOCLI members and has been officially endorsed by 33/40 EFLM and 21/21 COLABIOCLI members. We encourage professionals throughout Europe and Latin America to adopt and implement this recommendation to improve the quality of blood collection practices and increase patient and workers safety.
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| 8. |
- Simundic, Ana-Maria, et al.
(författare)
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Recomandarea comună EFLM-COLABIOCLI pentru recoltarea sângelui venos - v 1.1, iunie 2018 : [Joint EFLM-COLABIOCLI recommendation for venous blood sampling - v 1.1, June 2018]
- 2024
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Ingår i: Revista Romana de Medicina de Laborator. - : Sciendo. - 1841-6624. ; 32:1, s. 9-32
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Tidskriftsartikel (refereegranskat)abstract
- Acest document oferă o recomandare comună a Federației Europene de Chimie Clinică și Medicină de Laborator (EFLM), Grupu-lui de lucru pentru faza preanalitică (WG-PRE) și Grupului de lucru din America Latină pentru Faza preanalitică (WG-PRE-LATAM) al Confederației Americii Latine de Biochimie Clinică (COLABIOCLI) pentru recoltarea sângelui venos. Documentul oferă îndrumări asupra cerințelor pentru asigurarea faptului că procedura de recoltare a sângelui este una sigură, centrată pe pacient și oferă îndrumări practice despre cum să fie depășite cu succes potențiale bariere și obstacole în calea difuzării și implementării ei.Publicul țintă pentru această recomandare este personalul medical implicat direct în procesul de recoltare a sângelui. Aceastăre comandare se aplică în cazul utilizării unui sistem închis de recoltare a sângelui și nu oferă recomandări pentru recoltare asângelui cu seringi și catetere în sistem deschis. Mai mult, acest document nu abordează obținerea consimțământului pacientului, solicitarea testelor, manipularea și transportul probelor și nici recoltarea de la copii și pacienții inconștienți. Procedura recomandată se bazează pe cele mai bune dovezi disponibile. Fiecare pas a fost evaluat folosind un sistem care punctează calitatea dovezilor și puterea recomandării. Procesul de evaluare a fost realizat la mai multe întâlniri față în față implicând aceleași părți interesate menționate anterior. Principalele părți ale acestei recomandări sunt: 1) Proceduri de pre-recoltare, 2) Procedura de recoltare, 3) Proceduri de post-recoltare şi 4) Implementarea. O primă schiță a recomandării a fost transmisă membrilor EFLM pentru consultare publică. A fost invitat și WG-PRE-LATAM pentru a comenta documentul. O versiune revizuită a fost trimisă spre vot tuturor membrilor EFLM și COLABIOCLI și a fost aprobată oficial de 33 dintre cei 40 de membri EFLM și toți membri COLABIOCLI. Încurajăm profesioniștii din toată Europa şi America Latină să adopte şi să implementeze această recomandare pentru a îmbunătăți calitatea practicilor de recoltare a sângelui și creșterea siguranței pacientului și personalului medical.
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| 9. |
- van Dongen-Lases, Edmee C., et al.
(författare)
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Patient identification and tube labelling - a call for harmonisation
- 2016
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Ingår i: Clinical Chemistry and Laboratory Medicine. - : Walter de Gruyter GmbH. - 1434-6621 .- 1437-4331. ; 54:7, s. 1141-1145
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Tidskriftsartikel (refereegranskat)abstract
- Venous blood sampling (phlebotomy) is the most common invasive procedure performed in patient care. Guidelines on the correct practice of phlebotomy are available, including the H3-A6 guideline issued by the Clinical Laboratory Standards Institute (CLSI). As the quality of practices and procedures related to venous blood sample collection in European countries was unknown, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase conducted an observational study in 12 European countries. The study demonstrated that the level of compliance of phlebotomy procedures with the CLSI H3-A6 guideline was unacceptably low, and that patient identification and tube labelling are amongst the most critical steps in need of immediate attention and improvement. The process of patient identification and tube labelling is an essential safety barrier to prevent patient identity mix-up. Therefore, the EFLM Working Group aims to encourage and support worldwide harmonisation of patient identification and tube labelling procedures in order to reduce the risk of preanalytical errors and improve patient safety. With this Position paper we wish to raise awareness and provide recommendations for proper patient and sample identification procedures.
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