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Needle should be inserted into the vessel at an approximately 5-30 degree angle, depending on the vein's depth. (A) Inserting the needle for the users of pre-evacuated tubes and (B) inserting the needle for the users of blood collection systems using the aspiration technique.
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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 of...
Context in source publication
Context 1
... 9. Puncture the vein (Figure 3) 9.5 If a vein cannot be located, a slight repositioning of the needle (by moving the needle backward or for- ward) may help to find the vein. 9.6 The use of sharps device with flash visualization may be helpful, especially with non-experienced staff, or in children and patients with difficult veins. These devices provide a visible venous flash when the nee- dle is connected to the vein (Figure ...
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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 of...
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Citations
... The COLABIOCLI WG-PRE-LATAM recognised that patient safety could be compromised if the laboratory does not verify the validation requirements of the collection system before introducing a new component of the VBCS or changing the manufacturer [22]. Given these points, the joint recommendations of the EFLM and of the Latin American Confederation of Clinical Biochemistry indicate that only components of the same manufacturer and part of an integrated system should be used for the collection and treatment of blood [44]. The combination of components from different manufacturers may not be validated for the intended use and may compromise the safety of patients and healthcare professionals [44]. ...
... Given these points, the joint recommendations of the EFLM and of the Latin American Confederation of Clinical Biochemistry indicate that only components of the same manufacturer and part of an integrated system should be used for the collection and treatment of blood [44]. The combination of components from different manufacturers may not be validated for the intended use and may compromise the safety of patients and healthcare professionals [44]. ...
... The list of main messages presented in Table 3 was formulated to synthesise the retrieved evidence. There was high consistency in standards [21] and in documents from international and national scientific societies [8,25,28,44] about the need for preferring fully integrated VBCSs, where the compatibility of all system components (blood collection needles/sets, holders and tubes) is verified and validated, both in terms of safety and efficacy. The overall evidence level is moderate, supported by a body of evidence made by quality level 2 and 3 studies. ...
Venous blood collection systems (VBCSs) are combinations of in-vitro diagnostics and medical devices, usually available as integrated set. However, purchasing and using a combination of devices from different sets is considered by clinical laboratories as an option to achieve specific sampling tasks or reduce costs. This systematic review aimed to retrieve available evidence regarding safety, efficacy, and economic aspects of VBCSs, focusing on differences between integrated and combined systems. The literature review was carried out in PubMed. Cited documents and resources made available by scientific organisations were also screened. Extracted evidence was clustered according to Quality/Efficacy/Performance, Safety, and Costs/Procurement domains and discussed in the current European regulatory framework. Twenty documents published between 2010 and 2021 were included. There was no evidence to suggest equivalence between combined and integrated VBCSs in terms of safety and efficacy. Scientific society’s consensus documents and product standards report that combined VBCS can impact operators’ and patients’ safety. Analytical performances and overall efficacy of combined VBCSs are not guaranteed without whole system validation and verification. EU regulatory framework clearly allocates responsibilities for the validation and verification of an integrated VBCS, but not for combined VBCSs, lacking information about the management of product nonconformities and post-market surveillance. Laboratory validation of combined VBCS demands risk-benefit and cost-benefit analyses, a non-negligible organisational and economic burden, and investment in knowledge acquisition. Implications in terms of laboratory responsibility and legal liability should be part of a comprehensive assessment of safety, efficacy, and cost carried out during device procurement.
... The first minute's pulse rate immediately after stopping the step test was recorded as the recovery heart rate [34]. Blood was drawn under the guidelines provided by [35]. Before sampling, participants were allowed to sit for fifteen minutes. ...
Background and Study Aim: A recent study indicates that Ethiopian middle- and long-distance athletes originate from diverse geographical regions, including areas of varying elevation. This study aimed to analyze the impact of altitude training on hematological parameters and recovery heart rates among young male endurance trainees training at sites located at different altitude levels.
Material and Methods: The study employed a quasi-experimental, counterbalanced approach involving 15 male trainees. Five individuals from each training center experienced the standard training program across three distinct geographical locations and elevations. Pre- and post-test data were collected on red blood cells, hemoglobin, hematocrit, platelet count, and recovery heart rate before and after six months, from 6:00–8:00 AM. ANCOVA was utilized to analyze the data.
Results: Following the intervention, the mean Red Blood Cell (RBC) count was observed to be higher in trainees from low altitude (5.18±0.33) compared to those from moderate altitude (4.48±0.14 and 5.21±0.22), with a significance level of p<0.05. The mean Hemoglobin (HGB) count was found to be higher in moderate altitude trainees (17.00±0.70 and 16.31±0.65) than in low altitude trainees (15.82±1.37), although this difference was not statistically significant (p>0.05). Similarly, the mean Hematocrit (HCT) count was low for both low altitude (46.04±3.49) and moderate altitude trainees (46.46±3.9 and 45.42±1.54), with no significant difference noted (p>0.05). The mean Platelet (PLT) count was 226.8±75.88 for low altitude trainees and 265.8±23.18, 276±53.96 for moderate altitude trainees, with no significant difference between the groups (p>0.05). As for the recovery heart rate, mean values showed no significant difference between the pre-and post-test groups. In the pretest, the mean recovery heart rate was 30.00±14.70 for low-altitude trainees and 43.20±8.90, 43.20±13.68 for moderate-altitude trainees (p>0.05). In the post-test, the mean recovery heart rate was 25.20±7.82 for low-altitude trainees and 32.40±10.04, 36.00±7.35 for moderate-altitude trainees (p>0.05).
Conclusions: The findings indicate that training at different altitudes impacts the hematological and cardiovascular systems of endurance athletes in varied ways. This underscores the importance of developing tailored training programs to optimize performance and recovery. These results are particularly relevant for coaches and athletes seeking to enhance endurance training outcomes through altitude training strategies.
... Various guidelines exist that address patient preparation and its importance for venous blood sampling, for instance, the GP41 guideline issued by the Clinical Laboratory Standards Institute (CLSI) in 2017 [3] and the blood collection guidelines published by the World Health Organisation in 2010 [4]. Recommendations provided by national societies [5] or international organisations in the field of radiology, such as The Contrast Media Safety Committee of the European Society of Urogenital Radiology [6], or in the field of laboratory medicine, such as the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and the Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin American Confederation of Clinical Biochemistry (COLABIOCLI) [7,8], also guide this practice. Several years ago, the Working Group for Preanalytical Phase (WG-PRE) of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) proposed that blood for all routine blood tests should be taken preferably in the morning, after an overnight fast (12 h), allowing water consumption, but prohibiting the consumption of tea, coffee, and other caffeine-containing drinks or alcohol, refraining from intensive physical activity and cigarette smoking before blood sampling [7]. ...
... Recommendations provided by national societies [5] or international organisations in the field of radiology, such as The Contrast Media Safety Committee of the European Society of Urogenital Radiology [6], or in the field of laboratory medicine, such as the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and the Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin American Confederation of Clinical Biochemistry (COLABIOCLI) [7,8], also guide this practice. Several years ago, the Working Group for Preanalytical Phase (WG-PRE) of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) proposed that blood for all routine blood tests should be taken preferably in the morning, after an overnight fast (12 h), allowing water consumption, but prohibiting the consumption of tea, coffee, and other caffeine-containing drinks or alcohol, refraining from intensive physical activity and cigarette smoking before blood sampling [7]. These recommendations align with various studies that have shown that non-fasting [9,10], or the use of chewing gum before sampling [11], intensive physical activity [12], and medication use [13][14][15], could introduce bias into laboratory test results. ...
1) Background: Various guidelines address patient preparation and its importance for venous blood sampling, such as the GP41 guideline issued by the Clinical Laboratory Standards Institute (CLSI) and the blood collection guidelines published by the World Health Organisation. Recommendations provided by national societies or international organisations in the field of radiology, such as The Contrast Media Safety Committee of the European Society of Urogenital Radiology, or in the field of laboratory medicine, such as the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and the Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin American Confederation of Clinical Biochemistry (COLABIOCLI), also guide this practice. There is a notable lack of understanding regarding the viewpoints held by non-laboratory healthcare professionals concerning the significance of patient preparation for laboratory testing and the impact of typical factors associated with patient preparation. This study endeavours to bridge this gap by assessing the attitude of non-laboratory healthcare professionals in Lithuania regarding these pivotal aspects. (2) Methods: A self-designed anonymous questionnaire was disseminated among 141 public healthcare institutions in Lithuania. The internal consistency of the questionnaire was evaluated by computing Cronbach's alpha. Descriptive statistics were utilised for the variables, while comparisons of attitude among groups were conducted using Mann-Whitney U (for two groups) or Kruskal-Wallis (for more than two groups) for categorical and discrete indicators. The Kruskal-Wallis post-hoc test was employed for pairwise comparisons. A significance level of p-Value < 0.05 was applied to establish statistical significance. (3) Results: A total of 158 respondents constituted two distinct groups of healthcare professionals: nurses and physicians. Most of the participants either agreed or strongly agreed that patient preparation could introduce bias into laboratory test results. Professionals with less than 20 years of work experience or those who attended training in patient preparation for sampling within a 5-year timeframe exhibited stronger agreement regarding different preanalytical factors in patient preparation and their impact on laboratory test results compared to their counterparts. (4) Conclusions: Non-laboratory healthcare professionals who participated in this survey consider proper patient preparation for laboratory testing to be a significant step towards obtaining accurate test results. They also recognize the commonly acknowledged preanalytical factors as important for ensuring reliable test results. However, attitudes towards the importance of several preanalytical factors vary depending on whether non-laboratory healthcare professionals have more or less than 20 years of work experience, as well as whether they have attended any training on this topic within the last five years or have never attended such training. Keywords: preanalytical phases; attitude of health personnel; clinical laboratory testing; quality of health care Healthcare 2024, 12, 989.
... Proper needle selection is necessary, as excessively thin needles can cause hemolysis (Mouser et al., 2017). When collecting blood samples from children, professional collectors can enhance the efficiency of blood collection and minimize discomfort to the participants (Simundic et al., 2018). To prevent hemolysis, the tourniquet should be correctly positioned and not left in place too long during blood drawing (Phelan et al., 2018). ...
Cell-free DNA (cfDNA), a burgeoning class of molecular biomarkers, has been extensively studied across a variety of biomedical fields. As a key component of liquid biopsy, cfDNA testing is gaining prominence in disease detection and management due to the convenience of sample collection and the abundant wealth of genetic information it provides. However, the broader clinical application of cfDNA is currently impeded by a lack of standardization in the preanalytical procedures for cfDNA analysis. A number of fundamental challenges, including the selection of appropriate preanalytical procedures, prevention of short cfDNA fragment loss, and the validation of various cfDNA measurement methods, remain unaddressed. These existing hurdles lead to difficulties in comparing results and ensuring repeatability, thereby undermining the reliability of cfDNA analysis in clinical settings. This review discusses the crucial preanalytical factors that influence cfDNA analysis outcomes, including sample collection, transportation, temporary storage, processing, extraction, quality control, and long-term storage. The review provides clarification on achievable consensus and offers an analysis of the current issues with the goal of standardizing preanalytical procedures for cfDNA analysis.
... (1). This procedure involves a series of sequential steps that must be executed meticulously to obtain high-quality blood samples for analysis (1)(2)(3)(4). ...
... To minimise the rate of occurrence of these errors, it is crucial to adhere to proper recommendations for phlebotomy. Various guidelines exist for VBS, also recommendations provided by national societies or international organisations in the field of laboratory medicine also guide this practice, including recommendations of the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and the Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin America Confederation of Clinical Biochemistry (COLABIOCLI) issued in 2018 (2,4,13,14). The EFLM-COLABIOCLI recommendations describe the procedure based on risk and evidence assessment, and grade recommendations for each step based on the quality and strength of the available evidence (4). ...
... Various guidelines exist for VBS, also recommendations provided by national societies or international organisations in the field of laboratory medicine also guide this practice, including recommendations of the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and the Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin America Confederation of Clinical Biochemistry (COLABIOCLI) issued in 2018 (2,4,13,14). The EFLM-COLABIOCLI recommendations describe the procedure based on risk and evidence assessment, and grade recommendations for each step based on the quality and strength of the available evidence (4). Healthcare professionals in Europe have been encouraged to incorporate these recommendations in their daily practice. ...
Introduction
The aim of this study was to determine the level of compliance of venous blood sampling (VBS) in Lithuania with the joint recommendations of the European Federation of Clinical Chemistry and Laboratory Medicine and the Latin American Confederation of Clinical Biochemistry (EFLM-COLABIOCLI) and to analyse possible causes of errors. A survey was conducted between April and September 2022.
Materials and methods
A self-designed questionnaire was distributed to the Lithuanian National Societies. Error frequencies and compliance score were computed. Differences between groups were analysed using Pearson’s chi-square, Fisher’s exact criterion, Mann-Whitney U (for two groups), or Kruskal-Wallis (for more than two groups) for categorical and discrete indicators. The association between ordinal and discrete variables was assessed using Spearman’s rank correlation coefficient. Statistical significance was determined at P < 0.05.
Results
A total of 272 respondents completed the questionnaire. Median error rate and compliance score were 31.5% and 13/19, respectively. Significant differences were found among professional titles, standard operating procedures availability, training recency, and tourniquet purpose opinions. A negative correlation was noted between compliance and time since training (rs = - 0.28, P < 0.001).
Conclusions
The findings of this study indicate that there is a significant need for improvement in compliance with the EFLM-COLABIOCLI recommendations on VBS among specialists in Lithuania. Essential measures include prioritizing ongoing phlebotomy training and establishing national guidelines. Harmonisation of blood collection practices across healthcare institutions is crucial.
... The importance of skin preparation prior to phlebotomy has been considered in guidelines produced by various scientific organisations [17,18]. The literature recommends the use of 70 % ethyl alcohol for lab-tested blood samples. ...
... The published guidelines recommend gloves as part of both the aseptic and personal protective measures that should be used by the health professional [17,18]. For simple phlebotomy, non-sterile gloves are recommended, while sterile gloves should be used for collecting blood cultures. ...
Aim: Blood Sampling Guidelines have been developed to target European emergency medicine-related professionals involved in the blood sampling process (e.g. physicians, nurses, phlebotomists working in the ED), as well as laboratory physicians and other related professionals. The guidelines population focus on adult patients. The development of these blood sampling guidelines for the ED setting is based on the collaboration of three European scientific societies that have a role to play in the preanalytical phase process: EuSEN, EFLM, and EUSEM. The elaboration of the questions was done using the PICO procedure, literature search and appraisal was based on the GRADE methodology. The final recommendations were reviewed by an international multidisciplinary external review group.
Results: The document includes the elaborated recommendations for the selected sixteen questions. Three in pre-sampling, eight regarding sampling, three post-sampling, and two focus on quality assurance. In general, the quality of the evidence is very low, and the strength of the recommendation in all the questions has been rated as weak. The working group in four questions elaborate the recommendations, based mainly on group experience, rating as good practice.
Conclusions: The multidisciplinary working group was considered one of the major contributors to this guideline. The lack of quality information highlights the need for research in this area of the patient care process. The peculiarities of the emergency medical areas need specific considerations to minimise the possibility of errors in the preanalytical phase.
... When we analyzed whether there was a correlation between the risk of hemolysis and the level of miR-30c-5p, its levels only showed a statistically significant correlation with the hemolysis delta Cq. In order to obtain hemolysis-free serum samples, certain precautions need to be taken during the extraction process [86]. In addition, there is a possibility that a sample first classified as non-hemolyzed may have hemolysis after measuring the hemoglobin absorbance or delta Cq [85]. ...
The diagnosis of endometriosis by laparoscopy is delayed until advanced stages. In recent years, microRNAs have emerged as novel biomarkers for different diseases. These molecules are small non-coding RNA sequences involved in the regulation of gene expression and can be detected in peripheral blood. Our aim was to identify candidate serum microRNAs associated with endometriosis and their role as minimally invasive biomarkers. Serum samples were obtained from 159 women, of whom 77 were diagnosed with endometriosis by laparoscopy and 82 were healthy women. First, a preliminary study identified 29 differentially expressed microRNAs between the two study groups. Next, nine of the differentially expressed microRNAs in the preliminary analysis were evaluated in a new cohort of 67 women with endometriosis and 72 healthy women. Upon validation by quantitative real-time PCR technique, the circulating level of miR-30c-5p was significantly higher in the endometriosis group compared with the healthy women group. The area under the curve value of miR-30c-5p was 0.8437, demonstrating its diagnostic potential even when serum samples registered an acceptable limit of hemolysis. Dysregulation of this microRNA was associated with molecular pathways related to cancer and neuronal processes. We concluded that miR-30c-5p is a potential minimally invasive biomarker of endometriosis, with higher expression in the group of women with endometriosis diagnosed by laparoscopy.
... Mostly, biomedical laboratory scientists (BLS) perform phlebotomy in Denmark, but also nurses and other trained phlebotomists [5]. Health care professionals must follow protocols to assure preanalytical quality and patient safety, which includes ethanol swabbing of the skin to prevent infection introduced mainly from the bacterial flora on the skin [6][7][8]. However, it has previously been disputed if disinfecting the skin with ethanol could cause spourious results and analytical bias for blood alcohol (p-ethanol) measurements. ...
... A new international guideline from 2018 favors alcohol swabbing to ensure patient safety -even for forensic matters. This European & Latin American working group recommends using ethanol, which must evaporate on the skin before performing phlebotomy [8]. Examples of other international bodies creating guidelines for laboratory practice procedures also include World Health Organization (WHO) and the Clinical and Laboratory Standard Institute (CLSI) [6,7]. ...
Swabbing with ethanol to disinfect the skin before venipuncture does not bias measurements of blood ethanol, as previously suspected. International evidence-based theory may not always be successfully integrated into local practices, where old customs may remain. So how are the local protocols for swabbing in practice – if they even do swab? Not disinfecting may risk patient safety. We aim to put a focus on the venipuncture disinfection procedure in practice when measuring blood alcohol for clinical matters and if their procedure refers to a guideline.
Specialized biomedical laboratory scientists (BLS) are typically responsible for the phlebotomy procedure in Denmark, thus questionnaires were sent to the relevant BLS in 2020 to map disinfection procedures in all Danish hospitals and affiliated blood draw clinics (n = 58).
The response rate was 93% (54/58). We observed an inter-laboratory dissimilarity in swabbing procedures, when measuring blood alcohol: A quarter did not use any disinfectant (26%), while the remaining disinfected with ethanol 55%, isopropanol 13%, and 6% with ethanol/chlorhexidine. Of the five Danish regions, three had a regional guideline (3/5), otherwise the swabbing protocol was locally based. There was a regional difference in disinfecting or not (Chi² p < 0,0001).
Danish protocols do not always parallel international literature and international guidelines. Not applying disinfectant may jeopardize patient safety. Laboratories are encouraged to work with evidence-based practice or follow newest standardized international guidelines.
... Blood samples were collected after 12 hours of fasting, and blood samples were collected from the participants and stored at -80 °C for further analysis. The venipuncture procedure was carried out according to standardized protocol and references (24). ...
Background: Multiple sclerosis is one of the most common demyelinating diseases of the central nervous system. We aimed to investigate serum and cerebrospinal fluid levels of different laboratory inflammatory biomarkers in patients with MS. Methods: A total of 120 subjects participated in the study, 60 of whom are diagnosed with MS, 30 with the final diagnose of non-inflammatory diseases of the CNS, and 30 healthy subjects representing the control group. Regarding to progression of radiological findings after 2 years from the initial diagnosis, MS group was divided into subgroups: with stationary radiological findings (n=30) and with radiologically proven disease progression (n=30). In all patients we analyzed levels of laboratory inflammatory biomarkers: CRP, NLR, GDF15 and NFs. Values of NFs and GDF15 were analyzed initial while the values of CRP and NLR were analyzed initial and after two years. Results: We found statistically lower GDF15 values and initial CRP values in MS group in regards to group with non-inflammatory diseases of the CNS (p=0.000). On the other side, we determined significant elevation of laboratory markers CRP and NLR, initial and after two years period, in MS subgroup with progression of MRI findings (p= 0.000 and p=0.050, respectively). Also we found a positive correlation of CRP and neurofilaments (r=0.243, p=0.04), as well as a positive correlation of CRP and GDF15 in patients with MS (r=0.769, p=0.000). Conclusion: We found significant elevation of laboratory markers of systemic inflammation, CRP and NLR in MS patients who developed disease progression based on MRI findings. Key words: Multiple sclerosis; Neutrophil to lymphocyte ratio; C reactive protein, Neurofilaments, Growth differentiation factor 15
... The biochemical parameters were determined in the blood samples. Standard operating procedures were followed for collection and classification of blood samples [18]. A Becton Dickinson closed venipuncture system (BD) was used to collect blood samples (Vacutainer, 22 standard wire gauge (SWG), and reusable adapters). ...
Several studies report the important role of an altered gut microbiota in the development of obesity, highlighting the potential use of probiotics in the treatment of obesity. The aim of this study is to investigate the effect of a novel probiotic approach on the expression of specific miRNAs and mRNAs associated with obesity in combination with the hypocholesterolemic octacosanol. Twenty overweight/obese women participated in a randomized, placebo-controlled, double-blind study and were randomly divided into two groups: the intervention group (daily one capsule containing Lactobacillus plantarum 299v (DSM9843), Saccharomyces cerevisiae var. boulardii, and 40 mg octacosanol; N = 12) and the placebo group (N = 8). Changes in lipid parameters and expression of miRNAs and mRNAs were assessed before (T0) and after the 12-week intervention (T1). After the intervention, the expression of miR-155-5p (9.38 ± 0.85 vs. 8.38 ± 1.06, p = 0.05) and miR-24-3p (3.42 ± 0.38 vs. 2.71 ± 0.97, p = 0.031) showed significant decreases in the intervention group when compared to the control group. At T1, the expression of miR-155-5p (8.69 ± 1.31 vs. 9.3 ± 0.85, p = 0.04), miR-125b-5p (5.41 ± 1.18 vs. 5.99 ± 1.36, p = 0.049), and TNF-α (10.24 ± 1.66 vs. 11.36 ± 1.12, p = 0.009) were significantly decreased in the intervention group. No changes in lipids and anthropometric parameters were observed. The novel probiotic approach had a positive effect on regulating the expression of certain miRNAs and mRNAs important for regulating inflammation and adipogenesis, which are essential for obesity onset and control.
