The final part of the CRESS trilogy - how to evaluate the quality of stability studies.

High quality laboratory results are critical for patient management. However, poor sample quality can impact these results and patient safety. To ensure reliable and accurate results laboratories must be aware of each analyte's stability under various storage conditions and matrices to guarantee correct and dependable outcomes. This knowledge allows laboratories to define the allowable delay between sample collection and centrifugation/analysis for all analytes to guarantee appropriate results quality and interpretation. The EFLM WG-PRE therefore established a 4-step plan to tackle this issue, aiming to standardize and harmonize stability studies for improved comparison and meta-analysis. The plan included the development of checklists and how-to guides for performing and reporting stability studies as well as a central resource of stability data. This manuscript deals with the issue of evaluating publications and incorporating them into a central resource. To evaluate stability studies, the CRESS checklist was used to structure 20 sections used to judge the quality of studies. Each section has 4 levels of quality, with scores converted to numerical values and weighted based on expert opinion. Based on this, a final score ranging from A to D was determined. The procedure was then tested on six manuscripts and checked for agreement between expert judgements. The results demonstrated that the proposed evaluation process is a useful tool to distinguish between best in class manuscripts and those of lower quality. The EFLM WG-PRE strongly believes that the provided recommendations and checklists will help improving stability studies both in quality and standardisation.

Verification of bile acid determination method and establishing reference intervals for biochemical and haematological parameters in third-trimester pregnant women.

OBJECTIVES: The aims of this study were to verify the bile acids (BA) method and to establish reference intervals (RIs) for bile acids (BA) and biochemical and haematological parameters in Croatian pregnant women. METHODS: BA spectrophotometric method verification was performed on Siemens Atellica Solution CH 930 automated analyser using Sentinel reagent. Stability, precision, trueness, linearity, and RIs, as well as lipemia interference were tested according to CLSI guidelines. BA, biochemical, and haematological parameters were measured in serum (BA, biochemical) and whole blood (haematological) samples of fasting healthy third-trimester pregnant women from Croatia (n=121). The establishment of the RIs was done a priori according to the CLSI EP28-A3C:2010 guideline. Selected reference individuals' data were analysed using parametric, non-parametric, and robust methods. RESULTS: Stability study showed that BA are stable in serum samples for 2 days at 20 °C, 14 days at 4-8 °C, and 22 days at -20 °C. The precision study and adult RIs verification met the criteria. Linearity was verified for the concentration range of 3.5-172.1 µmol/L whereas the lipemia interference test showed a positive bias (%) in BA concentration. The determined reference limits generally exhibited better precision for haematological parameters, being lower than the upper recommended value 0.2, unlike biochemical parameters. Haematological parameters showed notable differences between pregnant and non-pregnant women, while many biochemical parameters' RIs remained similar. Only ALT and GGT showed lower non-comparable RI upper limits in the population pregnant women. CONCLUSIONS: Spectrophotometric BA method showed satisfactory performance and all examined parameters were within the set criteria. Moreover, RIs for key biochemical and haematological parameters, including BAs, have been established for the first time in the population of Croatian pregnant women.

Analytical interference of intravascular contrast agents with clinical laboratory tests: a joint guideline by the ESUR Contrast Media Safety Committee and the Preanalytical Phase Working Group of the EFLM Science Committee.

The Contrast Media Safety Committee of the European Society of Urogenital Radiology has, together with the Preanalytical Phase Working Group of the EFLM Science Committee, reviewed the literature and updated its recommendations to increase awareness and provide insight into these interferences.

Analytical interference of intravascular contrast agents with clinical laboratory tests: a joint guideline by the ESUR Contrast Media Safety Committee and the Preanalytical Phase Working Group of the EFLM Science Committee.

The Contrast Media Safety Committee of the European Society of Urogenital Radiology has, together with the Preanalytical Phase Working Group of the EFLM Science Committee, reviewed the literature and updated its recommendations to increase awareness and provide insight into these interferences. CLINICAL RELEVANCE STATEMENT: Contrast Media may interfere with clinical laboratory tests. Awareness of potential interference may prevent unwanted misdiagnosis. KEY POINTS: • Contrast Media may interfere with clinical laboratory tests; therefore awareness of potential interference may prevent unwanted misdiagnosis. • Clinical Laboratory tests should be performed prior to radiological imaging with contrast media or alternatively, blood or urine collection should be delayed, depending on kidney function.

The Association of Serum Calprotectin with Fitness Indicators and Biochemical Markers in High-Level Athletes: A Continuous Dynamic Monitoring during One Competitive Season.

The objective was to determine the associations between several biochemical indicators and the dynamics of concentration change across four physical fitness phases over the period of a competitive season. Furthermore, associations between serum calprotectin and biomarkers of inflammation or muscle injury and physical indicators were examined. SUBJECTS AND METHODS: Twenty professional male water polo players (median age: 28 (22-42)) were included in this study. Serum creatine kinase activity was determined by the automated photometric UV method. The concentrations of calprotectin, C-reactive protein, and myoglobin were measured using an automated immunoturbidimetric method, while an automated immunochemistry method was employed for interleukin-6, troponin I, and cortisol determination. Tests of repeated strength, maximal strength, and static strength were used to evaluate physical activity. RESULTS: Serum calprotectin concentrations expressed in median and IQR were significantly different: T1: 2.92 g/mL (2.47; 3.86); T2: 2.35 g/mL (1.26; 2.87); T3: 2.27 g/mL (1.60; 3.27); and T4: 1.47 g/mL (1.04; 2.85) (p = 0.004). Cortisol concentration and CK activity showed significant changes among phases (p = 0.049 and p = 0.014, respectively). Each physical activity examined showed a significant seasonal decrease (all p values were 0.001). Calprotectin serum concentration and indicators of muscular injury, inflammation, and physical activity were found to be correlated during particular stages of the seasonal examination. CONCLUSIONS: Calprotectin values determined throughout one competitive season decreased as training intensity among water polo players increased. Serum calprotectin concentrations and indicators were related to biochemical markers of inflammation and muscle damage.

Recommendation for the design of stability studies on clinical specimens.

OBJECTIVES: Knowledge of the stability of analytes in clinical specimens is a prerequisite for proper transport and preservation of samples to avoid laboratory errors. The new version of ISO 15189:2022 and the European directive 2017/746 increase the requirements on this topic for manufacturers and laboratories. Within the project to generate a stability database of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Preanalytical Phase (WG-PRE), the need to standardise and improve the quality of published stability studies has been detected, being a manifest deficit the absence of international guidelines for the performance of stability studies on clinical specimens. METHODS: These recommendations have been developed and summarised by consensus of the WG-PRE and are intended primarily to improve the quality of sample stability claims included in information for users provided by assay supplier companies, according to the requirements of the new European regulations and standards for accreditation. RESULTS: This document provides general recommendations for the performance of stability studies, oriented to the estimation of instability equations in the usual working conditions, allowing flexible adaptation of the maximum permissible error specifications to obtain stability limits adapted to the intended use. CONCLUSIONS: We present this recommendation based on the opinions of the EFLM WG-PRE group for the standardisation and improvement of stability studies, with the intention to improve the quality of the studies and the transferability of their results to laboratories.

The preanalytical phase - from an instrument-centred to a patient-centred laboratory medicine.

In order to guarantee patient safety, medical laboratories around the world strive to provide highest quality in the shortest amount of time. A major leap in quality improvement was achieved by aiming to avoid preanalytical errors within the total testing process. Although these errors were first described in the 1970s, it took additional years/decades for large-scale efforts, aiming to improve preanalytical quality by standardisation and/or harmonisation. Initially these initiatives were mostly on the local or national level. Aiming to fill this void, in 2011 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group "Preanalytical Phase" (WG-PRE) was founded. In the 11 years of its existence this group was able to provide several recommendations on various preanalytical topics. One major achievement of the WG-PRE was the development of an European consensus guideline on venous blood collection. In recent years the definition of the preanalytical phase has been extended, including laboratory test selection, thereby opening a huge field for improvement, by implementing strategies to overcome misuse of laboratory testing, ideally with the support of artificial intelligence models. In this narrative review, we discuss important aspects and milestones in the endeavour of preanalytical process improvement, which would not have been possible without the support of the Clinical Chemistry and Laboratory Medicine (CCLM) journal, which was one of the first scientific journals recognising the importance of the preanalytical phase and its impact on laboratory testing quality and ultimately patient safety.

Diagnostic Workup of Microcytic Anemia: An Evaluation of Underuse or Misuse of Laboratory Testing in a Hospital Setting Using the AlinIQ System.

CONTEXT.­: Underuse of laboratory testing has been previously investigated in preselected populations, such as documented malpractice claims. However, these numbers might not reflect real-life situations. OBJECTIVE.­: To evaluate the underuse and misuse of laboratory follow-up testing in a real-life hospital patient population with microcytic anemia, using laboratory results ordered during routine patient care. DESIGN.­: From all patients in whom a microcytic anemia was detected during routine diagnostics in 2018, all available laboratory data were collected and screened for appropriateness of diagnostic workup of iron deficiency and thalassemia. Subgroup analysis was performed for patient groups with mean corpuscular volume values 75 to 79 µm3 (group 1), 65 to 74 µm3 (group 2), and <65 µm3 (group 3). RESULTS.­: A total of 2244 patients with microcytic anemia were identified. Follow-up testing for iron deficiency was not performed in 761 cases (34%). For inconclusive ferritin levels due to elevated C-reactive protein results (n = 336), reticulocyte hemoglobin content or soluble transferrin receptor levels were missing in 86 cases (26%). In patients with suspected thalassemia (n = 127), follow-up testing for hemoglobin variants was not performed in 70 cases (55%). Subgroup analysis showed that the frequency of underuse of iron status as well as thalassemia/hemoglobinopathy testing decreased from group 1 to group 3. When considering relevant preexisting anemia diagnoses, laboratory tests were underused in 904 cases (40.3%). CONCLUSIONS.­: Because 40% (n = 904) of the patients with microcytic anemia were potentially not followed up correctly, laboratory specialists are advised to act by implementing demand management strategies in collaboration with clinicians to overcome underuse of laboratory tests and to improve patient safety.

Is canine calprotectin in serum stabile after storage at low temperature?

BACKGROUND: In human and veterinary medicine calprotectin is most widely used in diagnosing different gastro-intestinal diseases. The aim of this study was to assess the stability of canine calprotectin (cCP) in serum after storage at low temperatures and imprecision of the method. METHODS: Blood samples were collected from dogs with different clinical diagnoses. Twenty-two dogs were included in this study. Calprotectin concentration was measured 4 hours after serum separation (T0), and after being frozen at - 80 °C for 8 (T1) and 16 weeks (T2). The maximum permissible difference (MPD) was derived from the equation for calculating total error (TE) TE = %Bias + (1.96 x %CV), where bias and coefficient of variation (CV) were defined by the manufacturer. The dogs enrolled in this study were patients admitted during the morning (9-12 a.m.), on the day the first measurement was performed. All sample analysis for determination of stability were done in duplicates. For determination of within-run precision, the two patients' serum samples were analyzed in 20 replicates. Imprecision was assessed by analyzing 20 replicates on one plate on two samples where high and low concentrations were anticipated. RESULTS: The calculated value of MPD was 32.52%. Median calprotectin concentrations were higher at T1 114.08 µg/L (IQR = 55.05-254.56) and T2 133.6 µg/L (IQR = 100.57-332.98) than at T0 83.60 µg/L (IQR = 50.38-176.07). Relative and absolute bias at T1 (49.3%; 45.98 µg/L) and T2 (109.93%; 94.09 µg /L) have shown that calprotectin concentrations increase after long term storage at - 80 °C. CONCLUSION: The results of the present study indicate that c-CP was not stable for 16 weeks at low storage temperature (- 80 °C). Considering the observed change in the concentration of c-CP at T1, a storage time of 8 weeks should be safely applied. The method imprecision was not satisfactory, especially in the lower concentration range.

Verification of a 6-part differential haematology analyser Siemens Advia 2120i.

Introduction: The aim of this study was to perform a comprehensive verification of a 6-part differential haematology analyser Siemens Advia 2120i (Erlangen, Germany), prior to its routine implementation. Materials and methods: Our verification protocol included: precision (within- and between-run), estimated bias (%) as measure of trueness, which was calculated from observed and manufacturers' declared value, analytical measuring interval (AMI), carryover, confirmation of a limit of blank (LoB), determination of a limit of detection (LoD) and limit of quantitation (LoQ). The K2 ethylenediaminetetraacetic acid (EDTA) patients' leftover samples were used for verification of analyser Advia 2021i. Acceptance criteria were based on manufacturer technical specifications (Siemens), 2016 state-of-the-art criteria (Vis and Huisman), and EFLM Biological Variation Database. Results: The within- and between-run precision were acceptable for all parameters and the lowest coefficients of variation were observed for mean corpuscular volume (MCV) (0.3% and 0.6%, respectively). Estimated bias was within the acceptance criteria for all parameters except for MCV (the estimated bias was 2.2% (acceptance criteria 2.0%). AMI was confirmed for all tested parameters (r > 0.99). The carryover estimates ranged from 0.1% for platelet count (Plt) to 0.6% for red blood cell count and were within the manufacturers' specifications (≤ 1%). Manufacturers' claims for LoB were confirmed for leukocytes, erythrocytes, haemoglobin, and platelets. The estimated LoD and LoQ were 0.05 x109/L and 0.1 x109/L for white blood cell count, while for Plt values were 2 x109/L and 3 x109/L, respectively. Conclusions: Analytical performance of the Siemens Advia 2120i meets predefined quality goals and is suitable for routine use in a clinical laboratory.

Serum and urine osmolality: 8 hours, 24 hours and 1-month sample stability.

OBJECTIVES: The body of literature varies significantly regarding serum and urine osmolality stability. Therefore, our aim was to investigate the stability of serum and urine osmolality at different temperatures (room temperature (RT) 4-8 °C, -20 °C) and time conditions (8 h, 24 h, 1 month). METHODS: The stability study was conducted following the CRESS guidelines, including 40 serum and urine samples. Samples were aliquoted into three aliquots and stored as follows: primary tube stored at RT for 8 h; two capped aliquots stored at 4-8 °C for 8 h and 24 h; one aliquot stored at -20 °C for 1 month. To minimize imprecision error, serum and urine osmolality were measured by the freezing point depression method in triplicate on OSMOMAT 3000 (Gonotech, Germany) analyzer. Percentage difference (PD%) against baseline measurement was calculated. Deviations were assessed against a reference change value of 5.0%. RESULTS: The PD% for serum and urine osmolality was below 2.0% for all time/temperature conditions. For serum samples: primary tube after 8 h at RT PD% (95% CI) = 0.0% (-0.3, 0.2%); 8 h at 4-8 °C PD% (95% CI) = -0.4% (-0.7, 0.0%); 24 h at 4-8 °C PD% (95% CI) = -0.7% (-0.7, -0.6%); 1 month at -20 °C PD% (95% CI) = -2.1% (-2.4, -1.5%). For urine samples: after 8 h at RT PD% (95% CI) =0.6% (0.2, 0.9%); 8 h at 4-8 °C PD% (95% CI) = -0.2% (-0.5, 0.1%); 24 h at 4-8 °C PD% (95% CI) = -0.2% (-0.5, 0.0%); 1 month at -20 °C PD% (95% CI) = -2.0% (-3.0, -1.0%). CONCLUSIONS: Changes in osmolality for tested conditions for serum and urine samples, were within acceptance criteria. Reflex and add-on osmolality testing can be performed within the same day in samples kept at RT for 8 h in primary tube and within 24 h, in aliquoted refrigerated samples, without compromising the reliability of test results. For longer storage, samples should be kept at -20 °C.

Preanalytical quality improvement - an interdisciplinary journey, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE).

Since the beginning of laboratory medicine, the main focus was to provide high quality analytics. Over time the importance of the extra-analytical phases and their contribution to the overall quality became evident. However, as the initial preanalytical processes take place outside of the laboratory and mostly without its supervision, all professions participating in these process steps, from test selection to sample collection and transport, need to engage accordingly. Focusing solely on intra-laboratory processes will not be sufficient to achieve the best possible preanalytical quality. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has provided several recommendations, opinion papers and scientific evidence over the past years, aiming to standardize the preanalytical phase across Europe. One of its strategies to reach this goal are educational efforts. As such, the WG-PRE has organized five conferences in the past decade with the sole focus on preanalytical quality. This year's conference mainly aims to depict the views of different professions on preanalytical processes in order to acquire common ground as basis for further improvements. This article summarizes the content of this 6th preanalytical conference.

Verification of automatic analysers Roller 20PN and iSED for measuring erythrocyte sedimentation rate.

INTRODUCTION: Automated erythrocyte sedimentation rate (ESR) analysers are based on different methodology than Westergren method. It is questionable whether ESR values obtained from those analysers are comparable with determined values with Westergren method. The aim was verification of the precision, method comparison and accuracy of automated ESR analysers: Roller 20PN (Alifax S.p.A., Polverara, Italy) and iSED (Alcor Scientific, Smithfield, USA). MATERIALS AND METHODS: Blood samples (N = 752 for Roller 20PN and N = 213 for iSED) were sampled into K2EDTA (Kima, Italy) tubes for automated and 3.8% Na-citrate tubes (Kima, Italy) for Westergren method. The data was divided into three groups according to the ESR values obtained with the Westergren method: Group Low (L) (ESR ≤ 20 mm), Group Medium (M) (ESR 21-60 mm), and Group High (H) (ESR ≥ 61 mm). Method agreement was assessed by Bland-Altman analysis and Passing-Bablok regression. RESULTS: Analyser iSED has shown better comparability with Westergren method (bias 0.0 (95%Cl -1.4 to 1.5) range than Roller 20 PN (bias = - 6.4 (95%Cl - 7.1 to -5.7) in the whole measuring. For Roller 20 PN, Passing-Bablok regression has shown constant and proportional difference for Groups L and M, and for iSED only for Group H. Roller 20 PN had lower sensitivity (0.51 (95%Cl: 0.45-0.57) than iSED (0.72 (95%Cl: 0.59-0.80) while they had comparable specificity (> 0.90) and accuracy (≥ 0.80) in comparison with the Westergren method. CONCLUSION: Both analysers are not comparable with the Westergren method and should not be used interchangeably.

Comparison of three different protocols for obtaining hemolysis.

OBJECTIVES: Hemolysis is associated with erroneous or delayed results. Objectives of the study were to compare four different methods for obtaining hemolysis in vitro on three different analyzers. METHODS: Hemolysis was prepared with addition of pure hemoglobin into serum pool, osmotic shock, aspiration through blood collection needle, freezing/thawing of whole blood. Biochemistry parameters were measured in duplicate at Architect c8000 (Abbott, Abbott Park, USA), Beckman Coulter AU680 (Beckman Coulter, Brea, USA) and Cobas 6000 c501 (Roche, Mannheim, Germany), according to manufacturers' declarations. Cut-off value was defined as the highest value of H index with corresponding bias lower than acceptance criteria. RESULTS: We were not able to obtain results with freezing protocol. On all three platforms, lowest number of analytes were sensitive to hemolysis at H=0.5 using method of adding free hemoglobin. When osmotic shock was used, cut-off values for the most analytes were generally met at lower values. Hemolysis significantly interfered with measurement of potassium and lactate dehydrogenase (LD) at H=0.5 on all platforms. The most of the tested analytes had the lowest acceptable H index when aspiration method was used. At the low level of hemolysis (H=0.8) glucose, sodium, potassium, chloride, phosphate, and LD were affected on all analyzers, with some additional analytes depending on the manufacturer. CONCLUSIONS: Hemolysis interference differs on different analyzers and according to protocol for obtaining hemolysis. Aspiration method was generally the most sensitive to hemolysis interference, while addition of free Hb was the most resistant.

Verification of Atellica 1500 and comparison with Iris urine analyser and urine culture.

INTRODUCTION: The aims of study were to assess: 1) performance specifications of Atellica 1500, 2) comparability of Atellica 1500 and Iris, 3) the accuracy of both analysers in their ability to detect bacteria. MATERIALS AND METHODS: Carryover, linearity, precision, reproducibility, and limit of blank (LoB) verification were evaluated for erythrocyte and leukocyte counts. ICSH 2014 protocol was used for estimation of carryover, CLSI EP15-A3 for precision, and CLSI EP17 for LoB verification. Comparison for quantitative parameters was evaluated by Bland-Altman plot and Passing-Bablok regression. Qualitative parameters were evaluated by Weighted kappa analysis. Sixty-five urine samples were randomly selected and sent for urine culture which was used as reference method to determine the accuracy of bacteria detection by analysers. RESULTS: Analytical specifications of Atellica 1500 were successfully verified. Total of 393 samples were used for qualitative comparison, while 269 for sediment urinalysis. Bland-Altman analysis showed statistically significant proportional bias for erythrocytes and leukocytes. Passing-Bablok analysis for leukocytes pointed to significant constant and minor proportional difference, while it was not performed for erythrocytes due to significant data deviation from linearity. Kappa analysis resulted in the strongest agreements for pH, ketones, glucose concentrations and leukocytes, while the poorest agreement for bacteria. The sensitivity and specificity of bacteria detection were: 91 (59-100)% and 76 (66-87)% for Atellica 1500 and 46 (17-77)% and 96 (87-100)% for Iris. CONCLUSION: There are large differences between Atellica 1500 and Iris analysers, due to which they are not comparable and can not be used interchangeably. While there was no difference in specificity of bacteria detection, Iris analyser had greater sensitivity.

Adherence to the Standards for Reporting of Diagnostic Accuracy Studies (STARD): a survey of four journals in laboratory medicine.

BACKGROUND: The Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement has been updated in 2015. Many diagnostic test accuracy (DTA) studies have been published in medical laboratory journals, but their adherence to the updated STARD statement remains unknown. METHODS: We searched the PubMed database to verify studies published in 4 laboratory journals, including Clinical Chemistry, Clinical Chemistry and Laboratory Medicine, Clinica Chimica Acta, and Clinical Biochemistry, in 2019. DTA studies were identified and their adherence to the STARD statement was assessed. RESULTS: A total of 45 studies were included in this analysis. Overall, 18 out of 34 STARD items were reported. The items (adherence rate) of sample size estimation (4%), adverse events (9%), protocol (9%), registration (16%), missing value (22%), indeterminate results (18%), and cross-tabulation (22%) were the most frequently unreported items. CONCLUSIONS: Adherence to the STARD statement in DTA articles published in laboratory medicine seems as yet unsatisfactory. Our study emphasizes the necessity to improve the reporting quality of DTA studies published in medical laboratory journals.

Survey on reporting of epithelial cells in urine sediment as part of external quality assessment programs in Brazilian laboratories.

INTRODUCTION: Epithelial cells (ECs) are structures regularly observed during urine microscopy analysis. The correct identification of EC subtypes can be useful since renal tubular epithelial cells (RTECs) are clinically relevant. We investigate the urinary ECs report and the judgement of its clinical importance by Brazilian laboratories. MATERIALS AND METHODS: A survey with four questions was made available to participants of the Urinalysis External Quality Assessment Program (EQAP) from Controllab. Laboratories composed 3 groups: (1) differentiating ECs subtypes: "squamous", "transitional" and "RTECs"; (2) differentiating ECs subtypes: "squamous" or "non-squamous" cells; (3) without ECs subtype identification. Participants did not necessarily answer to all questions and the answers were evaluated both within the same laboratory's category and within different categories of laboratories. RESULTS: A total of 1336 (94%) laboratories answered the survey; Group 1, 119/140 (85%) reported that ECs differentiation is important to the physician and 62% want to be evaluated by EQAP, while in Group 3, 455/1110 (41%) reported it is useful to them, however only 25% want be evaluated by EQAP. Group 2 laboratories 37/51 (73%) reported that the information is important, but only 13/52 (25%) are interested in an EQAP with differentiation of the 3 ECs subtypes. CONCLUSION: Most of the laboratories do not differentiate ECs in the three subtypes, despite the clinical importance of RTECs. Education of laboratory staff about the clinical significance of urinary particles should be considered a key priority.

Verification of technical characteristics and performance of VeinViewer Flex, ICEN IN-G090-2 and AccuVein AV400 transillumination devices.

BACKGROUND AND AIM: Transilluminator device allow healthcare professionals to visualize peripheral veins without using tourniquet. Aim of the study was to test the ability of three devices (Christie VeinViewer Flex (Christie, Lake Mary, Florida, USA), ICEN IN-G090-2 (ICEN Technology Company Limited, Guangdong, China) and AccuVein AV400 (AccuVein, New York, USA)) to present quality images thought defined criterion. MATERIALS AND METHODS: Study was designed as a comparison of technical characteristics, evaluation of image quality and assessment of applicability in different conditions (different viewing angels, conditions of lightning and image visibility under interference of humidity and body lotions) in reference person on two venipuncture sites. RESULTS: Devices have different technical characteristics and vary in optimal distance for good quality image (18-30 cm), number of presented veins (1-4), image dimension (6.0-90.3 cm2), length (1.5-8.0 cm) and thickness (2-5 mm) of the dominant blood vessel. Devices present different image visibility under different viewing angels, conditions of lightning and interference of humidity and body lotions (from good quality to unusable images). CONCLUSION: Transillumination devices differ in their technical characteristics and performance. The choice of the device should be based on the needs of the particular patient population and the intended use of the device.

How to meet ISO15189:2012 pre-analytical requirements in clinical laboratories? A consensus document by the EFLM WG-PRE.

The International Organization for Standardization (ISO) 15189:2012 standard aims to improve quality in medical laboratories through standardization of all key elements in the total testing process, including the pre-analytical phase. It is hence essential that accreditation bodies, assessing laboratories against ISO15189:2012, pay sufficient attention to auditing pre-analytical activities. However, there are significant differences in how technical auditors interpret the pre-analytical requirements described in ISO15189:2012. In this consensus document, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Pre-analytical Phase (WG-PRE) sets out to review pre-analytical requirements contained in ISO15189:2012 and provide guidance for laboratories on how to meet these requirements. The target audience for this consensus document is laboratory professionals who wish to improve the quality of the pre-analytical phase in their laboratory. For each of the ISO requirements described in ISO15189:2012, members of EFLM WG-PRE agreed by consensus on minimal recommendations and best-in-class solutions. The minimal consensus recommendation was defined as the minimal specification which laboratories should implement in their quality management system to adequately address the pre-analytical requirement described in ISO15189:2012. The best-in-class solution describes the current state-of-the-art in fulfilling a particular pre-analytical requirement in ISO15189:2012. We fully acknowledge that not every laboratory has the means to implement these best-in-class solutions, but we hope to challenge laboratories in critically evaluating and improving their current procedures by providing this expanded guidance.

A proposed Common Training Framework for Specialists in Laboratory Medicine under EU Directive 2013/55/EC (The Recognition of Professional Qualifications).

European Union (EU) Directive 2013/55/EC (The Recognition of Professional Qualifications) allows Member States to decide on a common set of minimum knowledge, skills and competences that are needed to pursue a given profession through a Common Training Framework. To be adopted the framework must combine the knowledge, skills and competences of at least one third of the Member States. Professionals who have gained their qualifications under a Common Training Framework will be able to have these recognised automatically within the Union. The backbone of the European Federation of Clinical Chemistry and Laboratory Medicine's (EFLM) proposed Common Training Framework for non-medical Specialists in Laboratory Medicine is outlined here. It is based on an Equivalence of Standards in education, training, qualifications, knowledge, skills, competences and the professional conduct associated with specialist practice. In proposing the recognition of specialist practice EFLM has identified 15 EU Member States able to meet Equivalence and in whom the profession and/or its training is regulated (an additional EU Commission requirement). The framework supports and contributes to the Directive's enabling goals for increasing professional mobility, safeguarding consumers and ensuring a more equitable distribution of skills and expertise across the Member States. It represents EFLM's position statement and provides a template for professional societies and/or competent authorities to engage with the EU Commission.