Search

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. [ABSTRACT FROM AUTHOR]

Background and Aims: The precision of biological examination results hinges on meticulous preparatory measures before analysis, known as the pre-analytical phase. This phase contributes significantly to error rates (48-68%). Our study assessed the pre-analytical phase in seven hospital departments at Mohammed VI University Hospital. The objective was to address key causes of pre-analytical nonconformities. Materials and Methods: During this investigation, we observed 331 samples from various departments: Central Laboratory, Nephrology, Internal Medicine, Visceral Surgery, Emergency Specialties, Paediatrics, and Neonatology. Our evaluation identified 4945 instances of preanalytical nonconformities. These cases encompassed issues with the prescription sheet (501), patient preparation (848), equipment preparation (295), sampling process (1957), waste management (323), and sample transfer (422). Results: Our analysis highlighted a multitude of pre-analytical nonconformities within the surveyed hospital departments. These discrepancies illuminated the critical areas where corrective and preventive measures were imperative to adhere to the standards set by the International Standard ISO15189 and to optimize patient care. Conclusions: The findings from this study underscore the paramount importance of the pre-analytical phase in ensuring accurate biological examination results. By implementing a series of targeted actions in the concerned hospital departments, we addressed the identified nonconformities. These actions encompassed ongoing education, staff awareness and support, regular audits, provision of technical resources such as manuals and sample catalogues, as well as the utilization of appropriate equipment for sample collection and transportation. Continuous learning remains essential, encompassing proper sampling techniques, packaging and transportation requisites, as well as procedures for identifying and rectifying biological sample nonconformities. [ABSTRACT FROM AUTHOR]

The study published in the International Journal of Laboratory Hematology explores the impact of preanalytical conditions on fibrin monomers (FMs) and D-dimer biomarkers. The research involved 20 healthy volunteers and compared nine simulated conditions to a reference condition. The study found that certain preanalytical conditions significantly affected FMs levels, while D-dimer levels remained consistent across all conditions. The findings suggest that FMs assays are sensitive to preanalytical artifacts, highlighting the importance of stringent guidelines for accurate measurements. [Extracted from the article]

Introduction: Reliable and accurate measurement of blood glucose concentration is of crucial importance for making clinical decisions in diagnosis diabetes, gestational diabetes and impaired fasting glucose tolerance. Materials and methods: Survey was performed in form of questionnaire. Questionnaire was sent to all Croatian laboratories (N = 204) in electronic form using SurveyMonkey cloud-based software (SurveyMonkey, Inc., San Mateo, USA) as an extra-analytical module of the Croatian EQA (External Quality Assessment) provider Croatian center for external quality assessment (CROQALM) in June 2023. Results: In total 148 (73%) of laboratories responded to the survey. Large proportion of laboratories never use glucose inhibitor tubes for random glucose measurement (more than half) or for glucose function tests (one quarter). Only three laboratories use recommended glycolysis inhibitor citrate. Many other inhibitors are also used, even if some of them are not recommended for plasma glucose measurement. Glucose is almost never (93%) sampled on ice when glucose inhibitor tube is not available. Conclusions: Laboratories in Croatia do not follow the recommended procedures regarding glycolysis inhibitors for glucose determination. [ABSTRACT FROM AUTHOR]

Alkaptonuria is characterized by the accumulation of homogentisic acid which causes dark coloration of urine upon standing, ochronosis, and arthritis. A 4-year old child was referred to our pediatric nephrologist with hyperoxaluria and a history of unexplained pink-to-brown discolouration of his diapers associated with a brown-staining of clothes and skin since he was six months old. He had no other symptoms and his past medical history only included minor child illnesses. His 11-month-old brother had the same dark discoloration of his diapers. Laboratory testing on a spot urine sample showed hyperoxaluria and nephrotic range proteinuria with low creatinine and normal albumin concentrations. Considered causes were hyperoxaluria, alkaptonuria, interfering substance, adulteration. The further diagnostic work-up revealed increased homogentisic acid in urine, compatible with alkaptonuria. Urinary creatinine and total protein measurements on Roche Cobas were, respectively, falsely decreased and increased in the presence of homogentisic acid. The false-low creatinine resulted in an elevated oxalate/creatinine ratio. Alkaptonuria can cause a false increase of results expressed per creatinine and should be excluded in case of an unexplained marked increase of urine total protein without a concomitant increase of albumin. [ABSTRACT FROM AUTHOR]

Introduction: Information about analyte stability is of crucial importance. The aims of this study were to determine the short- and long-term stability of synovial fluid calprotectin at various temperature conditions (4-8 °C for 7 days, - 20 °C and - 80 °C for 6 weeks). Materials and methods: Eleven samples from patients were included in this study. The samples were promptly transported at room temperature (RT) to the laboratory immediately after arthrocentesis. Upon arrival, the samples were transferred into plastic tubes without additives and pretreated with hyaluronidase solution. After centrifugation at 1500xg for 10 minutes at RT, the baseline calprotectin concentrations were determined. Seven aliquots were stored in LoBind tubes (Eppendorf) at 4-8 °C and the calprotectin was measured every day. Six additional aliquots were stored at temperatures - 20 °C and - 80 °C and the concentration of calprotectin was measured weekly. Analysis was done using Buhlmann fCAL turbo reagent on analyzer Siemens Atellica Solution (Siemens Healthcare, Erlangen, Germany). Data were analyzed by Microsoft Excel and MedCalc statistical software. The percentage difference (PD%) was calculated. The maximum permissible difference (MPD) was 9.1% for PD%. Results: The PD% with the corresponding 95% confidence intervals were inside the predefined MPD. The instability equations and correlation coefficient for storage temperatures were PD% = 0.1644 x time (day), r = 0.06, P = 0.614 for 4-8°C, PD% = 0.5190 x time (week), r = - 0.22, P = 0.080 for - 20°C, and PD% = 0.1316 x time (week), r = 0.08, P = 0.545 for - 80°C. Conclusions: The calprotectin in the synovial fluid is stable when stored long-term for 6 weeks at - 20 °C or at - 80 °C or short-term (7 days) at 4-8 °C. [ABSTRACT FROM AUTHOR]

Introduction: Adrenocorticotropic hormone (ACTH) is a peptide secreted by pituitary gland that plays an important role in regulating cortisol secretion. Its determination is difficult because of instability in whole blood. Several factors that influence ACTH stability in blood before analysis have been identified: temperature, hemolysis, time to centrifugation and presence of protease inhibitors. Published results on ACTH whole blood stability seem contradictory. Materials and methods: We performed a stability study in 10 healthy volunteers. Three different conditions were tested: ethylenediaminetetraacetic acid (EDTA) at 4 °C, EDTA + aprotinin at 4 °C, EDTA + aprotinin at room temperature. Stability was evaluated for 8 hours. Adrenocorticotropic hormone measurements and hemolysis index were performed respectively on Cobas e602 and c701 (Roche Diagnostics, Mannheim, Germany). We compared percentage deviations with total change limit using a threshold of 7.5%. Results: We showed that ACTH is stable 8 hours with EDTA at 4 °C, 4 hours with EDTA + aprotinin at 4 °C and 2 hours with EDTA + aprotinin at 22 °C. Conclusions: Aprotinin does not appear to give ACTH greater stability but can be used without exceeding 4 hours at 4 °C. Refrigerated pouch transport also seems to be more appropriate for ACTH in whole blood. [ABSTRACT FROM AUTHOR]

The preanalytical phase in clinical laboratory diagnostics is currently receiving more and more attention. This term describes one part of actions and aspects of the "brain-to-brain cycle" of the medical laboratory diagnostic procedure that take place before the analytical phase. However, the preanalytical activities, the handling of unsuitable samples and the reporting procedures are neither fully standardized nor harmonized worldwide. The influence of the properties of the blood collection needle must be acknowledged. In this work, we focused on the investigation of the internal structure and size of standardized 21G blood collection needles. All parameters were measured with a scanning electron microscope using a Jeol model JSM-6000PLUS. Our. The obtained data shows that the internal surfaces of the needles vary greatly from manufacturer to manufacturer (by around 35 %), and this may play an important role in influencing blood flow and even the risk of blood cell injury (especially hemolysis) during blood drawing. The differential actual needle diameters can vary greatly between needle manufactures and this variety may have a significant impact on laboratory values and may also lead to specimen rejection. [ABSTRACT FROM AUTHOR]

Objectives Artificial intelligence–based robotic systems are increasingly used in medical laboratories. This study aimed to test the performance of KANKA (Labenko), a stand-alone, artificial intelligence–based robot that performs sorting and preanalytical quality control of blood tubes. Methods KANKA is designed to perform preanalytical quality control with respect to error control and preanalytical sorting of blood tubes. To detect sorting errors and preanalytical inappropriateness within the routine work of the laboratory, a total of 1000 blood tubes were presented to the KANKA robot in 7 scenarios. These scenarios encompassed various days and runs, with 5 repetitions each, resulting in a total of 5000 instances of sorting and detection of preanalytical errors. As the gold standard, 2 experts working in the same laboratory identified and recorded the correct sorting and preanalytical errors. The success rate of KANKA was calculated for both the accurate tubes and those tubes with inappropriate identification. Results KANKA achieved an overall accuracy rate of 99.98% and 100% in detecting tubes with preanalytical errors. It was found that KANKA can perform the control and sorting of 311 blood tubes per hour in terms of preanalytical errors. Conclusions KANKA categorizes and records problem-free tubes according to laboratory subunits while identifying and classifying tubes with preanalytical inappropriateness into the correct error sections. As a blood acceptance and tube sorting system, KANKA has the potential to save labor and enhance the quality of the preanalytical process. [ABSTRACT FROM AUTHOR]

Copyright of FACSalud is the property of Revista FACSalud and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: The pneumatic tube system (PTS) is an automated and fast modality of transportation of biological samples, but it has been reported to induce preanalytical errors. Aim: To study the influence of transportation by PTS on biochemistry tests which are particularly sensitive to haemolysis and atmospheric pressure variation. Materials and methods: We compared laboratory results of arterial blood gas, sodium, potassium, chloride, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, glucose and haemolysis index of samples conveyed simultaneously by PTS and by courier. Results: We recruited 30 patients from the sampling room and 40 patients from the intensive care unit. Transport through PTS resulted in a significant increase in aspartate aminotransferase and potassium without exceeding the limits of acceptability. Potassium was significantly more increased for samples transported in a higher speed line (p =.048) but without exceeding the limits of acceptability. No significant impact was noted on haemolysis indices. The pO2 variations due to PTS transportation exceeded the limit of acceptability with significant intra-individual variations. Conclusion: Our PTS is validated for biochemistry tests results. It reduces turnaround times without affecting sample quality. However, the interpretation of arterial blood gas results should be careful for samples transported by PTS. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: This study aimed to investigate the effects of lipemia on clinical chemistry and coagulation parameters in native ultralipemic (NULM) and intravenous lipid emulsion (IVLE) spiked samples. Materials and methods: The evaluation of biochemistry (photometric, ion-selective electrode, immunoturbidimetric method), cardiac (electrochemiluminescence immunoassay method) and coagulation (the viscosity-based mechanical method for prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen and the immunoturbidimetric method for D-dimer) parameters were conducted. In addition to the main pools, five pools were prepared for both types of lipemia, each with triglyceride (TG) concentrations of approximately 2.8, 5.7, 11.3, 17.0 and 22.6 mmol/L. All parameters' mean differences (MD%) were presented as interferographs and compared with the desirable specification for the inaccuracy (bias%). Data were also evaluated by repeated measures of ANOVA. Results: Prothrombin time and APTT showed no clinically relevant interference in IVLE-added pools but were negatively affected in NULM pools (P < 0.001 in both parameters). For biochemistry, the most striking difference was seen for CRP; it is up to 134 MD% value with NULM (P < 0.001) at the highest TG concentration, whereas it was up to - 2.49 MD% value with IVLE (P = 0.009). Albumin was affected negatively upward of 5.7 mmol/L TG with IVLE, while there was no effect for NULM. Creatinine displayed significant positive interferences with NULM starting at the lowest TG concentration (P = 0.028). There was no clinically relevant interference in cardiac markers for both lipemia types. Conclusions: Significant differences were scrutinized in interference patterns of lipemia types, emphasizing the need for careful consideration of lipemia interferences in clinical laboratories. It is crucial to note that lipid emulsions inadequately replicate lipemic samples. [ABSTRACT FROM AUTHOR]

Microribonucleic acids (miRNAs) have emerged as a new category of biomarkers for many human diseases like cancer, cardiovascular and neurodegenerative disorders. MicroRNAs can be detected in various body fluids including blood, urine and cerebrospinal fluid. However, the literature contains conflicting results for circulating miRNAs, which is the main barrier to using miRNAs as non-invasive biomarkers. This variability in results is largely due to differences between studies in sample processing methodology, miRNA quantification and result normalization. The purpose of this review is to describe the various preanalytical, analytical and postanalytical factors that can impact miRNA detection accuracy and to propose recommendations for the standardization of circulating miRNAs measurement. [ABSTRACT FROM AUTHOR]

Purpose: Sample rejection is an important quality indicator pertaining to the preanalytical phase of a laboratory workflow and has a wide range of implications. This study is aimed to determine causes of blood sample rejection, identify areas with maximum rejects and assess impact of targeted training on the same. Methods: A prospective analytical cross-sectional study was conducted in a diagnostic laboratory of a tertiary care hospital. Blood samples collected for clinical biochemistry and hematology tests were monitored for rejections. The study was divided into three phases, in Phase I, rejection rates were monitored without any targeted training, in phase II training was given to phlebotomists in areas of rejection. In phase III, targeted training was omitted to determine effect of stopping the same, however routine training sessions continued. An evaluation of efficacy of training interventions was performed by comparing specimen rejection rates and patterns. Results: The overall rejection rate was 0.43%. Maximum rejections were seen from general wards in all phases. Hemolyzed and clotted samples comprised the vast majority (64.65 % in phase I, 68.72 % in second phase and 69.28% in the third phase) of the total rejections. There was significant reduction in rejections during the training phase, but the effect was seen dwindling when upon cessation of training. Conclusion: Sample rejection rates were significantly reduced upon targeted training. However, challenge lied in maintaining sustainability of reduced rejection rates. The findings mandate reviewing and redesigning processes of training periodically in sites of phlebotomy for optimizing quality assurance practices. [ABSTRACT FROM AUTHOR]

Many hospitals use pneumatic tube systems (PTS) for transport of diagnostic samples. Continuous monitoring of PTS and evaluation prior to clinical use is recommended. Data loggers with specifically developed algorithms have been suggested as an additional tool in PTS evaluation. We compared two different data loggers. Transport types – courier, conventional (cPTS) and innovative PTS (iPTS) – were monitored using two data loggers (MSR145® logger, CiK Solutions GmbH, Karlsruhe, Germany, and a prototype developed at the University Medicine Greifswald). Data loggers differ in algorithm, recording frequencies and limit of acceleration detection. Samples from apparently healthy volunteers were split among the transport types and results for 37 laboratory measurands were compared. For each logger specific arbitrary units were calculated. Area-under-the-curve (AUC)-values (MSR145®) were lowest for courier and highest for iPTS and increased with increasing recording frequencies. Stress (St)-values (prototype logger) were obtained in kmsu (1,000*mechanical stress unit) and were highest for iPTS as well. Statistical differences between laboratory measurement results of transport types were observed for three measurands sensitive for hemolysis. The statistical, but not clinical, differences in the results for hemolysis sensitive measurands may be regarded as an early sign of preanalytical impairment. Both data loggers record this important interval of beginning mechanical stress with a high resolution indicating their potential to facilitate early detection of preanalytical impairment. Further studies should identify suitable recording frequencies. Currently, evaluation and monitoring of diagnostic sample transport should not only rely on data loggers but also include diagnostic samples. [ABSTRACT FROM AUTHOR]

Purpose: Sample rejection is an important quality indicator pertaining to the preanalytical phase of a laboratory workflow and has a wide range of implications. This study is aimed to determine causes of blood sample rejection, identify areas with maximum rejects and assess impact of targeted training on the same. Methods: A prospective analytical cross-sectional study was conducted in a diagnostic laboratory of a tertiary care hospital. Blood samples collected for clinical biochemistry and hematology tests were monitored for rejections. The study was divided into three phases, in Phase I, rejection rates were monitored without any targeted training, in phase II training was given to phlebotomists in areas of rejection. In phase III, targeted training was omitted to determine effect of stopping the same, however routine training sessions continued. An evaluation of efficacy of training interventions was performed by comparing specimen rejection rates and patterns. Results: The overall rejection rate was 0.43%. Maximum rejections were seen from general wards in all phases. Hemolyzed and clotted samples comprised the vast majority (64.65 % in phase I, 68.72 % in second phase and 69.28% in the third phase) of the total rejections. There was significant reduction in rejections during the training phase, but the effect was seen dwindling when upon cessation of training. Conclusion: Sample rejection rates were significantly reduced upon targeted training. However, challenge lied in maintaining sustainability of reduced rejection rates. The findings mandate reviewing and redesigning processes of training periodically in sites of phlebotomy for optimizing quality assurance practices.

The use of artificial intelligence (AI) has become widespread in many areas of science and medicine, including laboratory medicine. Although it seems obvious that the analytical and post-analytical phases could be the most important fields of application in laboratory medicine, a kaleidoscope of new opportunities has emerged to extend the benefits of AI to many manual labor-intensive activities belonging to the pre-analytical phase, which are inherently characterized by enhanced vulnerability and higher risk of errors. These potential applications involve increasing the appropriateness of test prescription (with computerized physician order entry or demand management tools), improved specimen collection (using active patient recognition, automated specimen labeling, vein recognition and blood collection assistance, along with automated blood drawing), more efficient sample transportation (facilitated by the use of pneumatic transport systems or drones, and monitored with smart blood tubes or data loggers), systematic evaluation of sample quality (by measuring serum indices, fill volume or for detecting sample clotting), as well as error detection and analysis. Therefore, this opinion paper aims to discuss the state-of-the-art and some future possibilities of AI in the preanalytical phase.

Phlebotomy is presumably the most challenging preanalytical aspect in laboratory medicine. In Europe, inpatient phlebotomy is performed by nurses in 45–60 % of cases. We aimed to develop and test a novel phlebotomy assessment tool for nurses.

Glucose measurement plays a central role in the diagnosis of gestational diabetes mellitus (GDM). Because of earlier reports of overestimation of glucose in the widely used tubes containing granulated glycolysis inhibitor, the study assessed the performance of fast-clotting serum tubes as an alternative sample for the measurement of glucose. Glucose concentration in fast-clotting serum was compared to lithium-heparin plasma placed in an ice-water slurry after sample collection and glucose stability at room-temperature was studied. Blood samples from 30 volunteers were drawn in four different types of tubes (serum separator tubes, fast-clotting serum tubes, lithium-heparin tubes and sodium fluoride, EDTA and a citrate buffer (NaF–EDTA–citrate) tubes, all from Greiner Bio-One). Lithium-heparin tubes were placed in an ice-water slurry until centrifugation in accordance with international recommendations and centrifuged within 10 min. After centrifugation, glucose was measured in all tubes (timepoint T0) and after 24, 48, 72, 96 and 120 h of storage at 20–22 °C. NaF–EDTA–citrate plasma showed significant overestimation of glucose concentration by 4.7% compared to lithium-heparin plasma; fast-clotting serum showed glucose concentrations clinically equivalent to lithium-heparin plasma. In fast-clotting serum tubes, mean bias between glucose concentration after 24, 48, 72, 96 and 120 h and T0 was less than 2.4%. All individual differences compared to T0 were less than 6.5%. The results fulfill the acceptance criteria for sample stability based on biological variation. Fast-clotting serum tubes can be an alternative for the measurement of glucose in diagnosis and management of GDM and diabetes mellitus, especially when prolonged transportation is necessary. [ABSTRACT FROM AUTHOR]

The analysis of blood alcohol concentration (BAC), a pivotal toxicological test, concerns acute alcohol intoxication (AAI) and driving under the influence (DUI). As such, BAC presents an organizational challenge for clinical laboratories, with unique complexities due to the need for forensic defensibility as part of the diagnostic process. Unfortunately, a significant number of scientific investigations dealing with the subject present discrepancies that make it difficult to identify optimal practices in sample collection, transportation, handling, and preparation. This review provides a systematic analysis of the preanalytical phase of BAC that aims to identify and explain the chemical, physiological, and pharmacological mechanisms underlying controllable operational factors. Nevertheless, it seeks evidence for the necessity to separate preanalytical processes for diagnostic and forensic BAC testing. In this regard, the main finding of this review is that no literature evidence supports the necessity to differentiate preanalytical procedures for AAI and DUI, except for the traceability throughout the chain of custody. In fact, adhering to correct preanalytical procedures provided by official bodies such as European federation of clinical chemistry and laboratory medicine for routine phlebotomy ensures both diagnostic accuracy and forensic defensibility of BAC. This is shown to depend on the capability of modern pre-evacuated sterile collection tubes to control major factors influencing BAC, namely non-enzymatic oxidation and microbial contamination. While certain restrictions become obsolete with such devices, as the use of sodium fluoride (NaF) for specific preservation of forensic BAC, this review reinforces the recommendation to use non-alcoholic disinfectants as a means to achieve "error-proof" procedures in challenging operational environments like the emergency department. [ABSTRACT FROM AUTHOR]

The article explores a demand management approach to vitamin D testing over an 8-year period, implementing a mandatory additional information step during ordering. The study reveals a significant reduction in overall vitamin D orders, with potential cost savings estimated between 101292 to 516704 Euros. Topics include the impact on testing frequency, financial savings, and the importance of collaboration with stakeholders for a successful intervention.

Laboratories across the world are successfully using quality indicators (QIs) to monitor their performance. We aimed to analyze the effectiveness of using the peer group comparison and statistical tools such as sigma metrics for periodic evaluation of QIs and identify potential errors in the preanalytical, analytical, and postanalytical phases. We evaluated the monthly QIs for 1 year. A total of 11 QIs were evaluated across the three phases of the total testing process, using percentage variance, and sigma metric analysis. Our study observed that based on sigma metric analysis, the performance was good for all the QIs except for the number of samples with the inappropriate specimen hemolyzed samples, clotted samples, and turnaround time (Sigma value < 3). The percentage variance of QIs in all the phases was plotted in a Pareto chart, which helped us in identifying turnaround time and internal quality control performance are the key areas that contribute to almost 80% of the errors among all the QIs. Laboratory performance evaluation using QIs and sigma metric analysis helped us in identifying and prioritizing the corrective actions in the key areas of the total testing process. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

Alzheimer's disease (AD) is considered the most common cause of dementia in older people. Recently, blood-based markers (BBM) Aβ1-42, Aβ1-40, and phospho Tau181 (p-Tau181) have demonstrated the potential to transform the diagnosis and prognostic assessment of AD. Our aim was to investigate the effect of different storage conditions on the quantification of these BBM and to evaluate the interchangeability of plasma and serum samples. Forty-two individuals with some degree of cognitive impairment were studied. Thirty further patients were retrospectively selected. Aβ1-42, Aβ1-40, and p-Tau181 were quantified using the LUMIPULSE-G600II automated platform. To assess interchangeability between conditions, correction factors for magnitudes that showed strong correlations were calculated, followed by classification consistency studies. Storing samples at 4 °C for 8–9 days was associated with a decrease in Aβ fractions but not when stored for 1–2 days. Using the ratio partially attenuated the pre-analytical effects. For p-Tau181, samples stored at 4 °C presented lower concentrations, whereas frozen samples presented higher ones. Concerning classification consistency in comparisons that revealed strong correlations (p-Tau181), the percentage of total agreement was greater than 90 % in a large number of the tested cut-offs values. Our findings provide relevant information for the standardization of sample collection and storage in the analysis of AD BBM in an automated platform. This knowledge is crucial to ensure their introduction into clinical settings. [ABSTRACT FROM AUTHOR]

The aim was to evaluate the stability of serum bicarbonate at room temperature, depending on time to centrifugation and air exposure. Stability study was conducted in the laboratory of Clinical Hospital Centre Rijeka, Croatia in January-February 2022. Nine samples from 10 volunteers were collected in clot activator gel tubes (Greiner Bio-One). Bicarbonate was measured on Beckman Coulter AU480 (Beckman Coulter, Brea, USA). Three tubes were left at room temperature for 30 min, three tubes for 2 h, three tubes for 4 h until centrifugation. First tube from first group (baseline) was measured immediately after centrifugation. Other measurements were expressed as percentage deviation (PD%) from baseline. First tube was remeasured after 1 and 2 h (OT_0h_1h; OT_0h_2h). Second and third tubes were opened 1 and 2 h after centrifugation (C_0h_1h; C_0h_2h). Second group of tubes was processed the same way with 2-hour centrifugation delay (WB_2h; OT_2h_1h; OT_2h_2h; C_2h_1h; C_2h_2h), and third group with 4-hour delay (WB_4h; OT_4h_1h; OT_4h_2h; C_4h_1h; C_4h_2h). PD% was compared to Maximum Permissible Difference (MPD=5.69%). MedCalc statistical software was used (MedCalc, Ostend, Belgium). Bicarbonate baseline mean value (range) was 27.3 (23.4–29.6) mmol/L. Obtained PD% (95%CI) were: C_0h_1h 0.46 (−1.21, 2.12); C_0h_2h 0.18 (−2.22, 2.57); OT_0h_1h −6.46 (−7.57, −5.36); OT_0h_2h −10.67 (−12.13, −9.21); WB_2h −0.15 (−2.04, 1.74); C_2h_1h 0.01 (−1.52, 1.54); C_2h_2h −0.40 (−2.65, 1.85); OT_2h_1h −5.43 (−7.30, −3.55); OT_2h_2h −11.32 (−13.57, −9.07); WB_4h −0.85 (−3.28, 1.58); C_4h_1h −2.52 (−4.93, 0.11); C_4h_2h −3.02 (−5.62, 0.43); OT_4h_1h −7.34 (−9.64, −5.05); OT_4h_2h −11.85 (−14.38, −9.33). Serum bicarbonate is stable for 4 h in closed uncentrifuged tubes, another 2 h in closed tubes after centrifugation, and is unstable within 1 h in opened tube. [ABSTRACT FROM AUTHOR]

Obtaining suitable results unaffected by preanalytical factors is crucial for laboratory test results. Measurement of parathyroid hormone (PTH) is essential in the evaluation and management of calcium metabolism disorders. The aim of the present study is to evaluate the effects of preanalytical factors such as sample type, storage time and temperature on PTH measurement in the same protocol. Blood samples were collected from 30 healthy volunteers into Serum Separator Tubes (SST), Barricor plasma tubes and EDTA aprotinine tubes. Serum and plasma were analysed immediately after collection simultaneously in the same batch and stored at room temperature RT (250C) and at (40C) for 24 and 48 hours until reanalysis for PTH on DXI800 autoanalyser (Beckman Coulter, USA). Changes in different tubes under different storage conditions were recorded and compared to each other. Clinical decision levels were estimated using analytical desirable bias and reference change value(RCV). No difference was found between tubes in terms of intact PTH levels. From a statistical standpoint, intact PTH level was no longer stable after storage for 24, and 48, hours at 4 C° and 25 C° in both serum tubes and barricor tubes. However, the variations especially in barricor tubes were under analytical desirable bias limits at 4 C0 for 24 hours (-10.48%), and 48 hours (-15.42%) hours and the changes were also not clinically significant. Our results have shown that Barricor tubes are stable at 4 C° up to 48 hours.The stability of the measurements were both analytically and clinically acceptable. [Med-Science 2022; 11(2.000): 603-6]

Most errors in laboratory medicine occur in the pre- and post-analytical phases of the total testing process (TTP). In 2014, the Spanish Society of Laboratory Medicine (SEQCML) started the current Preanalytical Phase EQA Programme, with the objective of providing a tool for the improvement of the preanalytical phase. The aim of this study was to review the evolution of quality indicators (QI) and the comparability of established performance specifications (PS) with other EQA programmes.

Background: Preanalytical phase is largely dependent on phlebotomist. The most frequently encountered preanalytical errors are hemolysis, incorrect patient identification, clotted specimens and insufficient sample volume. These errors can mostly be attributed to faulty phlebotomy procedure. Objective: To assess phlebotomy errors by direct observation of laboratory professionals-patients interaction during phlebotomy procedure. Material and methods: This study used the real time observations of patient-laboratory staff interactions to collect first-hand data on phlebotomy errors. Five different phlebotomists were directly observed while performing phlebotomy procedure on 200 patients. A checklist was used to collect data on the phlebotomy procedure and errors. Results: During the observation period, 200 blood samples were drawn into 457 tubes by 5 phlebotomists and none of the procedures could meet all the quality criteria of good and safe phlebotomy practice as described by WHO. Conclusion: There is urgent need for standard operating protocols to standardize phlebotomist-patient interaction. Phlebotomy errors can damage the institution's reputation, diminish confidence in healthcare services and contribute to increase in total operating costs, both for the hospital and laboratory. While it is understood that human errors cannot be completely eliminated, compliance with best practices for blood collection may help in minimizing the errors.

This letter, published in the journal European Neurology, discusses the usefulness of cerebrospinal fluid (CSF) white blood cell count (WBC) in the diagnosis of neurosyphilis. The author reviewed several studies to determine the utility of elevated CSF WBC in patients with suspected neurosyphilis. The analysis showed a statistically significant greater likelihood of elevated CSF WBC in the neurosyphilis group compared to controls. However, there were methodological differences among the studies, and the current instrument standard for CSF cell counting has limitations. The author suggests that with improvements in laboratory technology, CSF WBC may become more important in diagnosing neurosyphilis and other neurological infectious diseases. [Extracted from the article]

Anti-nucleocapsid (NC) antibodies are produced in response to SARS-CoV-2 infection. Therefore, they are well suited for the detection of a previous infection. Especially in the case of seroprevalence studies or during the evaluation of a novel in-vitro diagnostic test, samples have been stored at <−70 °C (short- and long-term) or 2–10 °C (short-term) before analysis. This study aimed to assess the impact of different storage conditions relevant to routine biobanking on anti-NC antibodies. The preanalytical impact of short-term storage (84 [58–98] days) on <−70 °C and for 14 days at 2–10 °C was evaluated using samples from 111 donors of the MedUni Vienna Biobank. Long-term effects (443 [409–468] days) were assessed using 208 samples from Biobank Graz and 49 samples from Biobank Vienna. Anti-Nucleocapsid antibodies were measured employing electrochemiluminescence assays (Roche Anti-SARS-CoV-2). After short-term storage, the observed changes did not exceed the extent that could be explained by analytical variability. In contrast, results after long-term storage were approximately 20% higher and seemed to increase with storage duration. This effect was independent of the biobank from which the samples were obtained. Accordingly, the sensitivity increased from 92.6 to 95.3% (p=0.008). However, comparisons with data from Anti-Spike protein assays, where these deviations were not apparent, suggest that this deviation could also be explained by the analytical variability of the qualitative Anti-NC assay. Results from anti-NC antibodies are stable during short-term storage at <−70 °C and 2–10 °C. After long-term storage, a slight increase in sensitivity could not be ruled out. [ABSTRACT FROM AUTHOR]

Serum samples are generally used for the measurement of human chorionic gonadotrophin (hCG) to calculate second-trimester maternal screening results. Lower hCG concentrations correlate with a lower calculated risk of Down syndrome (DS). Hence, erroneously low hCG results due to fibrin clot may lead to misinterpretation. We present a 23-year-old woman with a pregnancy of 17+3 weeks. Blood was taken into the Becton-Dickinson (BD) vacutainer SST-II Advance tube (Ref: 367955). The hCG test was performed on Immulite 2000 XPi analyser (Siemens Healthcare Diagnostics Inc, Tarrytown, USA) with original reagents. The results of the same sample were found as 2566 U/L, 18,153 U/L, and 7748 U/L. Three consecutive results after removal of the small fibrin clot and recentrifugation were 18,878, 20,255, and 22,339 U/L. The risk of DS and MoM for the concentration of 2556 U/L hCG was < 1/10,000 and 0.14, respectively. For a hCG concentration of 20,255 U/L, these values were 1/5632 and 1.13, respectively. Laboratory professionals and technicians should be aware that erroneously low hCG results can be measured with the Immulite 2000 XPi due to interference from small fibrin clots. Falsely underestimated hCG values reduce the MoM values and thus the calculated risk of DS. [ABSTRACT FROM AUTHOR]

Clinical decision-making in emergency medicine is under constant pressure from demand and performance requirements, with blood tests being a fundamental part of this. However, the preanalytical process has received little attention. Therefore, this study aimed to investigate the quality of preanalytical phase processes in European emergency departments (EDs) from the perspectives of the three main providers: clinicians, nurses, and laboratory specialists. This online survey, distributed among European EDs and laboratories, was supported by the European Society for Emergency Nursing (EUSEN), European Society for Emergency Medicine (EuSEM), and the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). The size of the centres, the European region, the responder's profession and the country's economic condition were used as co-variables. We included 376 responses from all ED-related professions from 306 European centres. In 66.9% of all ED visits, at least one blood test was performed. Tests were requested mostly by nurses (44.6%) using electronic Order/Entry systems (65.4%). Only a minority (19%) reported not using laboratory quality indicators (QIs). Most responders defined the TAT starting point "when the laboratory receives the sample" (66.1%), defining the goal to be "less than 60 min" (69.9%), but only 42.4% of the centres estimated achieving this goal. Our survey illustrates the current situation on preanalytical blood sample processing in European EDs from the clinical and laboratory perspectives. The results emphasise the importance of the IT infrastructure and QI usage in this process and highlight some differences between European regions. [ABSTRACT FROM AUTHOR]

Objectives: Preanalytical phase is an elemental part of laboratory diagnostics, but is prone to humane errors. The aim of this study was to evaluate performance in preanalytical phase external quality assessment (EQA) cases. We also suggest preventive actions for risk mitigation., Methods: We included 12 EQA rounds (Labquality Ltd.) with three patient cases (36 cases, 54-111 participants, 7-15 countries) published in 2018-2023. We graded performance according to percentage of correct responses in each case as ≥900 % excellent, 70-89 % good, 50-69 % satisfactory, 30-49 % fair and <30 % poor. Performance was simultaneously failed with ≥10 % of responses leading to harmful events., Results: Overall performance was excellent in 7, good in 12, satisfactory in 10, fair in 4 and poor in 3 cases. Additionally, 7 cases showed failed performance. Routine requests with incorrect sample tubes or incorrect sample handling were detected with good performance. Lower performance was seen with sudden abnormal results, with rare requests, with false patient identification (never-events) and with incorrect test requests. Information technology (IT) solutions (preanalytical checklists, autoverification rules and patient specific notifications) could have prevented 33 of 36 preanalytical errors., Conclusions: While most common errors were detected with good performance, samples with rare requests or those requiring individualised consideration are vulnerable to human misinterpretation. In many instances, samples with preanalytical errors should have been identified and rejected before reaching the laboratory or being directed to analysis. Optimising IT solutions to effectively detect these preanalytical errors allows for focus on infrequent events demanding accessible professional consultation. EQA preanalytical cases may help in education of correct actions in these occasions., (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)

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.

Introduction: The aim of the study was to determine the current state of laboratory's extra-analytical phase performance by calculating preanalytical and postanalytical phase quality indicators (QIs) and sigma values and to compare obtained data according to desired quality specifications and sigma values reported by The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group - Laboratory errors and Patient Safety. Materials and methods: Preanalytical and postanalytical phase data were obtained through laboratory information system. Rejected samples in preanalytical phase were grouped according to reasons for rejection and frequencies were calculated both monthly and for 2019. Sigma values were calculated according to "short term sigma" table. Results: The number of rejected samples in laboratory was 643 out of 191,831 in 2019. Total preanalytical phase rejection frequency was 0.22%. According to the reasons for rejection, QIs and sigma values were: "Samples with excessive transportation time": 0.0036 and 5.47; "Samples collected in wrong container" 0.02 and 5.11. In December, QIs and sigma values were: "Samples with excessive transportation time": 0.01 and 5.34; "Samples collected in wrong container": 0.03 and 4.98. The postanalytical QIs and sigma values were: "Reports delivered outside the specified time": 0.34 and 4.21; "Turn around time of potassium": 56 minute and 3.84, respectively. There were no errors in "Critical values of inpatients and outpatients notified after a consensually agreed time". Conclusions: Extra-analytical phase was evaluated by comparing it with the latest quality specifications and sigma values which will contribute to improving the quality of laboratory medicine. [ABSTRACT FROM AUTHOR]

Objectives: We aimed to compare the levels of hemolysis in the blood collected using the vacuum and aspiration modes via Sarstedt S-Monovette coagulation tubes.Methods: Forty volunteers were included in the study. Blood samples were collected using two different modes in the S-Monovette citrate tube (Sarstedt AG). Prothrombin time, active partial thromboplastin time, fibrinogen, and D-dimer analyses were performed using the STA-Compact-Max 3 analyzer (Stago). The hemolysis levels of the samples were measured by both Stago's semiquantitative hemolysis index (H-index) module and the quantitative H-index measurement of the Roche cobas 6000 (Roche Diagnostics) analyzer.Results: Roche's quantitative H-index values were statistically significantly lower in the aspiration mode. No clinically significant difference was observed between coagulation test results.Conclusions: Using the S-Monovette citrate tubes can reduce spurious hemolysis and improve patient safety. [ABSTRACT FROM AUTHOR]

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). 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%. 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%). 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. [ABSTRACT FROM AUTHOR]

• There is no need of preserving 24 h urine samples when stored at room temperature for up to 72 h. • This finding facilitates sample collection and may improve patient compliance and safety. • If needed, preservation may be done only after collection and prior to analysis. Recommendations on the optimal preservation of 24 h urine for the metabolic work-up in urolithiasis patients are very heterogeneous. In case two such tests with different storage condition recommendations are being analysed, multiple collections would be needed, challenging especially elderly and very young patients. We therefore aimed to evaluate the stability of urine constituents under different storage conditions. We collected urine samples from ten healthy volunteers and prepared aliquots to be stored either at room temperature or 4 °C. Some aliquots were preserved using hydrochloric acid prior to storage, some thereafter, some using the BD Urine preservation tube and some were not preserved at all. Storage duration was 0, 24, 48 or 72 h. In all samples calcium, magnesium, phosphorus, creatinine, oxalate, citrate and uric acid were measured and compared to the according reference sample. We could not find any significant deviation for any of the analytes and preanalytical treatment conditions compared to the associated reference sample. Preservation of 24 h urine for the metabolic evaluation in stone formers might not be necessary for sample storage up to 72 h. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Errors in the laboratory process often occur in the preanalytical phase (PA). The study aims to calculate the direct cost elements of PA errors, including material, logistics, transfer, personnel workforce, and medical waste. METHODS: Medical laboratory PA phase errors were retrospectively reviewed using the Laboratory Information Management System. We evaluated the whole 2019 laboratory data of the 836-bed Health Sciences University Umraniye Training and Research Hospital (UTRH). We assessed the direct cost elements of PA errors, such as those related to material, logistics, transfer, human resources, and waste. We performed the procedure for both samples analyzed in the hospital and transferred to the central laboratory. RESULTS: We analyzed 1,939,650 patient samples and 46,534,532 parameters studied in 2019 for UTRH. The rates for rejected tests and rejected samples (tube) for UTRH were noted as 0.32% and 1.7%, respectively. The total direct cost for PA errors was TRY 438,284.51 (68,918.07 euros) for 32,783 patient samples and 147,893 tests. We calculated the total cost for PA test errors detected in the hospital as TRY 390,238.06, while the total cost for PA test errors detected in the central laboratory was TRY 48,046.45. 89% of the total cost was for PA errors detected in the hospital, and 11% was for the errors detected in the central laboratory. The 2019 direct PA error cost we calculated based on our hospital’s data was 0.153% of the 2019 hospital operating cost. We calculated the direct cost per rejected sample as TRY 13.37 (2.1 Euro). CONCLUSION: Providing reliable laboratory service with the least possible financial loss is one of the main goals in terms of laboratory medicine. In achieving this goal, the prevention of error costs is a priority. The direct cost elements for the PA phase, where laboratory errors are concentrated, can be easily identified. The amount of PA phase error direct cost will attract the attention of health policy decision-makers and field professionals and inspire further research. Therefore, we tried to determine a threshold cost regarding interventions and practices required to prevent PA phase errors. [ABSTRACT FROM AUTHOR]

Introduction: Kidney stone formers can have higher oxalate and phosphate salt amounts in their urine than healthy people and we hypothesized that its acidification may be useful. The study aims to compare results of urine concentrations of calcium, magnesium, and inorganic phosphorus in the midstream portion of first voided morning urine samples without (FMU) and with post-collection acidification (FMUa) in kidney stone patients. Materials and methods: This is a prospective single center study. A total of 138 kidney stone patients with spot urine samples were included in the study. Urine concentrations of calcium, magnesium and inorganic phosphorus were measured with and without post-collection acidification. Acidification was performed by adding 5 µL of 6 mol/L HCl to 1 mL of urine. Results: The median age (range) of all participants was 56 (18-87) years. The median paired differences between FMU and FMUa concentrations of calcium, magnesium, and inorganic phosphorus were: - 0.040 mmol/L, 0.035 mmol/L, and 0.060 mmol/L, respectively. They were statistically different: P < 0.001, P < 0.001, P = 0.004, respectively. These differences are not clinically significant because biological variations of these markers are much higher. Conclusions: No clinically significant differences in urinary calcium, magnesium, and inorganic phosphorus concentrations between FMU and FMUa in patients with kidney stones were found. [ABSTRACT FROM AUTHOR]

Objectives: Most errors in laboratory medicine occur in the pre- and post-analytical phases of the total testing process (TTP). In 2014, the Spanish Society of Laboratory Medicine (SEQCML) started the current Preanalytical Phase EQA Programme, with the objective of providing a tool for the improvement of the preanalytical phase. The aim of this study was to review the evolution of quality indicators (QI) and the comparability of established performance specifications (PS) with other EQA programmes. Methods: In the SEQCML programme, participants were asked to register rejections of the main specimens and the causes for rejections. Data collected from 2014 to 2017, and then reviewed biennially (2018-2019), was used to calculate the percentiles; p25, p50, p75, and p90 for every round, and their means were set as PS. These PS were compared with the results of other programmes. Results: The evolution of QI results for 2018-2019 period showed general maintenance or improvement, e.g., a significant decrease in the number of serum samples with a haemolytic index =0.5 g/L, except for EDTA and citrate samples handle, maybe for an improvement in detection. The comparison with PS for the QI of the IFCC Working Group "Laboratory Errors and Patient Safety" and the Key Incident Management and Monitoring System (KIMMS) programme of the RCPA showed comparable results, supporting the validity of the established specifications. Conclusions: The PS obtained are a helpful tool for benchmarking and to identify processes of the preanalytical phase whose improvement should be set as a priority. [ABSTRACT FROM AUTHOR]

Obtaining suitable results unaffected by preanalytical factors is crucial for laboratory test results. Measurement of parathyroid hormone (PTH) is essential in the evaluation and management of calcium metabolism disorders. The aim of the present study is to evaluate the effects of preanalytical factors such as sample type, storage time and temperature on PTH measurement in the same protocol. Blood samples were collected from 30 healthy volunteers into Serum Separator Tubes (SST), Barricor plasma tubes and EDTA aprotinine tubes. Serum and plasma were analysed immediately after collection simultaneously in the same batch and stored at room temperature RT (250C) and at (40C) for 24 and 48 hours until reanalysis for PTH on DXI800 autoanalyser (Beckman Coulter, USA). Changes in different tubes under different storage conditions were recorded and compared to each other. Clinical decision levels were estimated using analytical desirable bias and reference change value(RCV). No difference was found between tubes in terms of intact PTH levels. From a statistical standpoint, intact PTH level was no longer stable after storage for 24, and 48, hours at 4 C° and 25 C° in both serum tubes and barricor tubes. However, the variations especially in barricor tubes were under analytical desirable bias limits at 4 C0 for 24 hours (-10.48%), and 48 hours (-15.42%) hours and the changes were also not clinically significant. Our results have shown that Barricor tubes are stable at 4 C° up to 48 hours.The stability of the measurements were both analytically and clinically acceptable. [ABSTRACT FROM AUTHOR]

Abstract Background The determination of CA 15-3 is useful for monitoring breast cancer patients. Several retrospective studies determined CA 15-3 levels in frozen samples to evaluate the sensitivity and specificity of novel biomarkers in relation to breast cancer; however, freeze-thaw cycles, as well as preanalytical variables before sample storage, are not always reported. Here, we analyzed the current scientific literature to identify possible critical aspects related to CA 15-3 determination in frozen-stored human serum/plasma samples. Methods We obtained data from 4 different bibliographic databases: Web of Science, Embase, PubMed, and Cochrane Library. We followed the PRISMA guidelines to screen and select the eligible articles discussed in the final revision. Results Initially, 674 scientific papers were evaluated, and after the application of the screening and eligibility criteria, 18 studies were included in the qualitative synthesis. The analysis reported an important level of heterogeneity concerning the preanalytical phase before sample storage. Conclusion Although advances in healthcare have been achieved using certified workflows in medical diagnostics, standardized preanalytical processes are not always applied when referring to frozen-stored biosamples. Biobanks will guarantee the best possible conditions for the storage of human biological samples to be used in clinical research. The use of certified bioresources will favor the optimal development and introduction of new disease biomarkers.

Objectives: The purpose of this study is to evaluate cobas parathyroid hormone (PTH) measurement effect of plasma samples obtained from underfilled tubes with ethylenediaminotetraacetic acid (EDTA). Methods: Two blood collection tubes with K3-EDTA from 67 patients at the same time were taken. One of them was for routine PTH measurement, which was filled to its capacity, while another tube was underfilled. All EDTA tubes were immediately centrifuged at 4°C. Plasma PTH concentrations were measured by electrochemiluminescence immunoassay method on the cobas e 601 (Roche Diagnostics GmbH, Mannheim, Germany) analyzer. Results: The underfilled sample tubes were grouped according to their being up to 25% (n=9), 25–50% (n=35), and 50–100% (n=23) of the appropriate amount. In all groups of underfilled tubes, the PTH values were found to decrease concerning those fulfilled (p<0.001). The agreement among underfilled and fulfilled for measuring PTH demonstrated a bias of −3.2 pg/mL (−5.9%) for the underfilled tubes. Conclusion: Insufficiently filled blood in tubes with EDTA has a significant effect on PTH levels. However, further studies are needed to show whether this effect is clinically significant. [ABSTRACT FROM AUTHOR]

Background: The application of the Lean methodology in clinical laboratories can improve workflow and user satisfaction through the efficient delivery of analytical results. The purpose of this study was to optimise delivery times of the test results at a clinical laboratory, using Lean management principles in the pre-analytical phase. Methods: A prospective study with a quasi-experimental design was implemented. Staff functions were restructured and sample flows were modified. Delivery times of clinical results (glucose and haematocrit; 6648 data) from the Medicine and Adult Emergency services for years 2017 and 2018 were compared. Results: A reduction (p < 0.05) in turnaround times in the delivery of glucose test results at the adult emergency service was observed (84 to 73 min, 13%, pre and post). In addition, there was a non-significant reduction in the turnaround times for glucose (Medicine) and haematocrit in both services. In the analytical and post-analytical phase (not intervened), an increase in turnaround times was observed in some cases. Conclusions: Other studies have indicated that the application of the Lean methodology in clinical laboratories improves workflow, increasing effectiveness and efficiency. This study showed an improvement in the delivery time of test results (glucose - Emergency), giving rise to a culture of cooperation and continuous improvement. It would, however, be essential to address the management model integrating the analytical and post-analytical phases.

Background: Despite the existence of international guidelines for the correct assessment of dysmorphic hematuria, its categorization frequently presents a lot of variability, even among professionals in the same laboratory. Objective: To determine the level of knowledge of professional medical technologists for the assessment of dysmorphic red blood cells in urinary sediment. Material and Methods: Observational cross-sectional study. A measurement instrument was applied to assess knowledge about the preanalytical and analytical phase of the assessment of dysmorphic red blood cells in urinary sediment to 113 professionals with more than three years of experience in the area of ​​urinalysis and who work in state and private hospitals. Results. The mean score obtained was 5.4±1.9 out of 10 possible points; 85.0% of the respondents presented medium and insufficient knowledge and only 15.0% advanced knowledge; An association was observed between levels of knowledge and years of experience (p=0.006), no significant association was found with the variable gender (p=0.791) and hospital locations (p=0.888). Discussion: Low knowledge was evidenced in the preanalytical and analytical domains for the assessment of dysmorphic red blood cells, in addition to a significant association between the level of knowledge and the years of experience of the professional. [ABSTRACT FROM AUTHOR]

Background Phlebotomy guidelines discourage tourniquet use whenever possible. We assessed phlebotomists' capability of not using the tourniquet in venous blood sampling, hypothesizing it to be equal to 50% of the patients attended, and identifying the most frequent venipuncture site. Materials and Methods We assigned two phlebotomists of the same age (41 years) and experience (20 years) to record 10 phlebotomy days, the first with prioritized and the latter with nonprioritized patients. Each acquired daily data for the number of attended patients, age, gender, frequency of nontourniquet usage, and punctured vein. To test our work hypothesis we used the two-tailed single sample t -test. Differences between age-group means and nontourniquet use means by each phlebotomist were tested by two-tailed t -test for independent means. Results In 10 phlebotomy days, 683 patients were attended (males 43.2%). We found no statistically significant difference between age-group means. The combined capability of nontourniquet use was 50.5%, which did not differ from our null hypothesis, but the difference in individual group means was statistically significant, the means being 33% and 66.9% (prioritized vs. nonprioritized). The medial cubital vein was the most prone to be punctured (77.7%). Conclusion Performing phlebotomies without tourniquet was possible in at least half of the attended patients, though it was more limited in specific group populations. [ABSTRACT FROM AUTHOR]