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 (EF

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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European views on patients directly obtaining their laboratory test results

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2015-0056 ◽

2015 ◽

Vol 53 (12) ◽

Cited By ~ 3

Author(s):

Ian D. Watson ◽

Joanna Siodmiak ◽

Wytze P. Oosterhuis ◽

Joel Corberand ◽

Per E. Jorgensen ◽

...

Keyword(s):

Information Technologies ◽

Clinical Chemistry ◽

Information Age ◽

Negative Attitude ◽

Laboratory Medicine ◽

European Federation ◽

Test Results ◽

Laboratory Test Results ◽

Laboratory Results ◽

Changing Practices

AbstractMedicine is a highly professionalized endeavour, by tradition centred on the authority of physicians. Better education and the advent of the information age cater for increased demands on society in general and on health care in particular to enable people to make informed decisions regarding themselves. Participation in medical decisions requires informed knowledge which is hard to obtain without substantial and time consuming professional help.We performed a survey amongst the member organizations of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in order to investigate the recognition and preparedness of providing help to patients in interpreting their laboratory results.Out of 40 EFLM Member Societies, 27 sent their responses to the survey. In most cases the first line delivery of laboratory results to physicians is by computer link (63%). Patients receive their laboratory results on demand from their physician in 60% of cases. However, 34% of laboratory specialists showed a negative attitude for delivering laboratory results to patients. Yet, in 48% of countries 1–5 patients per day ask a laboratory specialist about the significance of laboratory results outside the reference range. When patients are informed about the purpose of laboratory testing, they seek information primarily from their physician, followed by the internet and the Specialist in Laboratory Medicine.Changing practices increasingly enabling patient access to their records are on the increase facilitated by recent innovations in information technologies. Successful transfer of some of the responsibilities of physicians, demands a mutual triangular dialogue between the patient, their physician and laboratory medicine.

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Ontario COVID-19 assessment centre practices in patient counselling, education, and follow-up care: A provincial survey

Official Journal of the Association of Medical Microbiology and Infectious Disease Canada ◽

10.3138/jammi-2020-0052 ◽

2021 ◽

pp. e20200052

Author(s):

Helen Genis ◽

Scott MacPhee ◽

Nancy Vandenbergh ◽

Chris Yu ◽

Nisha Andany ◽

...

Keyword(s):

Patient Education ◽

Online Survey ◽

High Volume ◽

System Level ◽

Test Results ◽

Educational Materials ◽

Patient Counselling ◽

Follow Up Care ◽

Assessment Centre

BACKGROUND: In March 2020, COVID-19 assessment centres were launched across the province of Ontario to facilitate COVID-19 testing outside of emergency departments. We aimed to study the degree to which assessment centres provide education and follow-up care for patients with suspected COVID-19. METHODS: We conducted an online survey of Ontario COVID-19 assessment centre directors between September 15 and October 15, 2020. The primary outcomes studied were the types of educational modalities employed and information conveyed, methods and frequency of test result communication, and any follow-up care that was offered. Survey respondents were also asked to provide descriptions of barriers to patient education and test communication. RESULTS: A total of 56 directors (representing 73 assessment centres) completed the survey. The most frequent educational modalities employed were educational handouts (92%), direct in-person counselling (89%), and referral to website (72%). Seventy-one percent of respondents indicated patients with positive test results would be notified, and 61% of respondents indicated that follow-up care would be offered. The most frequently reported barriers to patient education were insufficient time and high volume of tests, while the most frequently reported barriers to communication of test results were difficulty accessing online health portals and high volume of tests. CONCLUSION: The ability of many assessment centres to provide patient education is limited by both individual patient and system-level factors. Assessment centres may benefit from standardization of educational materials, improved accessibility to test results for patients in marginalized groups, and virtual pathways to facilitate additional counselling and care for individuals who test positive.

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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 Pha

Biochemia Medica ◽

10.11613/bm.2019.020704 ◽

2019 ◽

Vol 29 (2) ◽

pp. 322-333 ◽

Cited By ~ 4

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.

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How to assess the quality of your analytical method?

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2015-0869 ◽

2015 ◽

Vol 53 (11) ◽

Cited By ~ 17

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.

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

Journal of Medical Biochemistry ◽

10.5937/jomb0-31250 ◽

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.

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Do laboratories follow heart failure recommendations and guidelines and did we improve? The CARdiac MArker Guideline Uptake in Europe (CARMAGUE)

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2012-0510 ◽

2013 ◽

Vol 51 (6) ◽

Cited By ~ 6

Author(s):

Angelika Hammerer-Lercher ◽

Paul Collinson ◽

Marja P. van Dieijen-Visser ◽

Kari Pulkki ◽

Janne Suvisaari ◽

...

Keyword(s):

Heart Failure ◽

Clinical Chemistry ◽

Package Insert ◽

European Federation ◽

Moderate Increase ◽

Cardiac Marker ◽

Web Based ◽

The Past ◽

Initial Survey

AbstractNatriuretic peptides (NP) are well-established markers of heart failure (HF). During the past 5 years, analytical and clinical recommendations for measurement of these biomarkers have been published in guidelines. The aim of this follow-up survey was to investigate how well these guidelines for measurement of NP have been implemented in laboratory practice in Europe.Member societies of the European Federation of Clinical Chemistry and Laboratory Medicine were invited in 2009 to participate in a web-based audit questionnaire. The questionnaire requested information on type of tests performed, decision limits for HF, turn-around time and frequency of testing.There was a moderate increase (12%) of laboratories measuring NP compared to the initial survey in 2006. The most frequently used HF decision limits for B-type NP (BNP) and N-terminal BNP (NT-proBNP) were, respectively, 100 ng/L and 125 ng/L, derived from the package inserts in 55%. Fifty laboratories used a second decision limit. Age or gender dependent decision limits were applied in 10% (8.5% in 2006). The vast majority of laboratories (80%) did not have any criteria regarding frequency of testing, compared to 33% in 2006.The implementation of NP measurement for HF management was a slow process between 2006 and 2009 at a time when guidelines had just been established. The decision limits were derived from package insert information and literature. There was great uncertainty concerning frequency of testing which may reflect the debate about the biological variability which was not published for most of the assays in 2009.

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Thoughts and expectations of young professionals about the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2020-0717 ◽

2021 ◽

Vol 59 (1) ◽

pp. 71-77

Author(s):

Josep Miquel Bauçà ◽

Claudia E. Imperiali ◽

Juan Robles ◽

Jorge Díaz-Garzón ◽

Dora Vuljanic ◽

...

Keyword(s):

Online Survey ◽

Clinical Chemistry ◽

Laboratory Medicine ◽

Current Status ◽

Clinical Aspects ◽

European Federation ◽

Scientific Training ◽

Group Activities ◽

Young Professionals ◽

Small Group Activities

AbstractObjectivesYoung laboratory medicine professionals (YLMPs) are the future of clinical laboratories. Although everyday practice shows significant differences among countries, especially during residency training, most of them face the same challenges. Besides promoting scientific, professional and clinical aspects of laboratory medicine in Europe, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) should take into consideration YLMPs’ concerns and interests to help them achieve excellence. The aim of this survey was to assess the opinion and expectations of YLMPs about their involvement in the activities of EFLM.MethodsAn online survey was distributed to YLMPs in Europe through different channels. The questionnaire consisted of 21 items grouped into five sections: demographic questions, opinion about the current status of YLMPs within EFLM, YLMPs network, suggestions and opportunities, and scientific training and exchange. Where appropriate, responses from residents and specialists were compared.ResultsA total of 329 valid responses were obtained from 53 different countries. Countries with the highest number of participants were Spain, Turkey, Croatia and Romania. A significant percentage would like to know more about EFLM and their activities (86%) and wish EFLM promoted networking and scientific exchanges (95%), for instance by means of a European YLMPs network (93%). EFLMLabX project was widely unknown (75%).ConclusionsYLMPs demand better connection to share concerns about daily healthcare duties, to keep updated and to advance professionally. EFLM needs to improve their advertising through national societies to increase YLMPs’ participation. In addition to international meetings and congresses, respondents have emphasized that workshops and other small group activities would significantly help promote laboratory medicine practice in Europe.

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Facilitating Parental Involvement in Speech Therapy for Children With Speech Sound Disorders: A Survey of Speech-Language Pathologists' Practices, Perspectives, and Strategies

American Journal of Speech-Language Pathology ◽

10.1044/2020_ajslp-19-00071 ◽

2020 ◽

Vol 29 (4) ◽

pp. 1987-1996

Author(s):

Sherine R. Tambyraja

Keyword(s):

Parental Involvement ◽

Online Survey ◽

Speech Therapy ◽

Speech Sound ◽

Speech Sound Disorders ◽

Speech Sound Disorder ◽

Speech Language Pathologists ◽

School Based ◽

Homework Completion

Purpose This study investigated the extent to which speech-language pathologists (SLPs) facilitate parents' completion of homework activities for children with speech sound disorder (SSD). In addition, this study explored factors related to more consistent communication about homework completion and strategies considered particularly effective for supporting this element of parental involvement. Method Licensed SLPs serving at least one child with SSD were invited to participate in an online survey. Questions relevant to this study gathered information regarding (a) frequency of communication about homework distribution and follow-up, (b) demographic and workplace characteristics, and (c) an open-ended question about the specific strategies used to support parental involvement and completion of homework activities. Results Descriptive results indicated considerable variability with respect to how frequently SLPs engaged in communication about homework completion, but that school-based SLPs were significantly less likely to engage in this type of follow-up. Strategies considered effective, however, were similar across therapy contexts. Conclusion These results suggest potentially important differences between school-based services and therapy in other contexts with respect to this particular aspect of service provision for children with SSD.

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Topical Bimatoprost Insert for Primary Open-Angle Glaucoma and Ocular Hypertension Treatment - A Phase II Controlled Study

Current Drug Delivery ◽

10.2174/1567201818666210101112256 ◽

2021 ◽

Vol 18 ◽

Author(s):

Francine Rubião ◽

Alan Cezar Faria Araújo ◽

João Bernardo Sancio ◽

Bárbara Silva Nogueira ◽

Juçara Ribeiro Franca ◽

...

Keyword(s):

Ocular Hypertension ◽

Primary Open Angle Glaucoma ◽

Open Angle Glaucoma ◽

T Test ◽

Controlled Study ◽

Therapeutic Drug ◽

Eye Drops ◽

Open Angle ◽

Drug Concentrations

Background: The most common treatment for primary open-angle glaucoma (POAG) is the daily use of eye drops. Sustained-release drug delivery systems have been developed to improve patient adherence by achieving prolonged therapeutic drug concentrations in ocular target tissues while limiting systemic exposure. The purpose of this study is to compare the efficacy and safety of bimatoprost inserts with bimatoprost eye drops in patients with POAG and ocular hypertension (OH). Methods: We include OH and POAG patients aged between 40 and 75 years-old. Both OH and POAG patients had intraocular pressure (IOP) greater than 21 and ≤30 mmHg at 9:00 am without glaucoma medication and normal biomicroscopy. Five normal patients with IOP≤14 mmHg constitute the control group. A chitosan-based insert of bimatoprost was placed at the upper conjunctival fornix of the right eye. In the left eye, patients used one drop of LumiganTM daily at 10:00 pm. For statistical analysis, we used a two-way analysis of variance (ANOVA), Student t-test, and paired t-test. Results: Sixteen POAG and 13 OH patients with a mean age of 61 years were assessed. In both eyes, IOP reduction was similar during three weeks of follow-up (19.5±2.2 mmHg and 16.9±3.1 mmHg), insert, and eye drop, respectively; P=0.165). The percentage of IOP reduction in the third week was 30% for insert and 35% for eye drops (P=0.165). No intolerance or discomfort with the insert was reported. Among the research participants, 58% preferred the use of the insert while 25% preferred eye drops, and 17% reported no preference. Conclusions: Bimatoprost-loaded inserts showed similar efficacy to daily bimatoprost eye drops during three weeks of follow up, without major side effects. This might suggest a possible change in the daily therapeutic regimen for the treatment of POAG and OH.

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