Pre-analytical Phase Research Articles

A Comprehensive Evaluation of the Preanalytical Phase in Laboratory Medicine, Nephrology, Emergency Specialties, Visceral Surgery, Pediatrics, Internal Medicine and Neonatology Hospital Departments: In-Depth Insights derived from an analysis of practices at a Medical University Centre in Morocco

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 pre-analytical 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

From the Operating Theater to the Pathology Laboratory: Failure Mode, Effects, and Criticality Analysis of the Biological Samples Transfer.

Introduction: The frozen section intra-operative consultation is a pathology procedure that provides real-time evaluations of tissue samples during surgery, enabling quick and informed decisions. In the pre-analytical phase, errors related to sample collection, transport, and identification are common, and tools like failure mode, effects, and criticality analysis help identify and prevent risks. This study aims to enhance patient safety and diagnostic quality by analyzing risks and optimizing sample management. Materials and Methods: The failure mode, effects, and criticality analysis was conducted by a multidisciplinary team to analyze the workflow of frozen section sample handling from collection in the operating theater to acceptance at the pathology lab. Six steps were identified, each assigned tasks and responsibilities, with risks assessed through the risk priority number, calculated from severity, occurrence, and detectability. Severity was classified based on the WHO framework, ranging from "No Harm" to "Death", to prioritize risks effectively. Results: The study identified 12 failure modes across 11 sub-processes, prioritized by risk. Key failures included missing patient identification, incorrect sample retrieval, missing labels, misdirected samples, and samples sent to the wrong lab. Discussion: Pre-analytical errors in pathology pose risks to diagnosis and patient care, with most errors occurring in this phase. A multidisciplinary team identified key issues, such as sample mislabeling and delays due to staff unavailability, and implemented corrective actions, including improved signage, staff re-training, and sample tracking systems. Monitoring and regular checks ensured ongoing adherence to protocols and reduced the risks of misidentification, transport delays, and procedural errors. Conclusions: The frozen section intra-operative consultation is vital in surgical pathology, with the pre-analytical phase posing significant risks due to potential errors in sample handling and labeling. Failure mode, effects, and criticality analysis has proven effective in identifying and prioritizing these failures, despite resource demands, by allowing corrective actions that enhance patient safety and healthcare quality.

Appraisal of six sigma in pre-analytical phase of clinical biochemistry laboratory

Objectives: The aim of the study is to measure the performance of pre-analytical phase of a clinical biochemistry laboratory using sigma metrics and the six sigma scale. Materials and Methods: The study included documented data of blood sample rejection from March 2023 to February 2024 and follow-up data from March 2024 to August 2024. International Federation of Clinical Chemistry and Laboratory Medicine developed Quality Indicators (QIs) used are QI-9 Wrong tubes; QI-10 Hemolyzed samples; QI-11 Clotted samples; QI-12 Insufficient samples; QI-14 Damaged samples in transport; and QI-15 Mislabeled samples. Based on “Six Sigma Quality Design and Control” established by Dr. Westgard, the sigma metric was calculated for the above-mentioned QIs. Statistical analysis: Obtained data were entered and analyzed using Microsoft Excel 2021. Results: Out of 162,380 received samples, 547 samples were rejected as not satisfied with the sample acceptance criteria. The most common pre-analytical error in the observed QIs is hemolyzed samples (458), followed by insufficient sample volume (55). The Sigma score of QI-10 was determined to be 4.81, whereas QI-9, QI-11, QI-12, and QI-15 were well maintained and graded excellent. Following training sessions, the follow-up month revealed a sigma score of 4.98 for QI-10. Conclusions: Six sigma metrics are a competent means to measure the performance of pre-analytical QIs in a clinical biochemistry laboratory. The observed QIs were effectively managed (>4 σ).

PCR GeneScan Analysis of Rearranged Immunoglobulin or T-Cell Receptor Genes for Clonality Diagnostics in Suspect Lymphoproliferations.

Assessment of the presence of clonal lymphoproliferations via polymerase chain reaction (PCR)-based analysis of rearranged immunoglobulin (IG) or T-cell receptor (TR) genes is a valuable method in the diagnosis of suspect lymphoproliferative disorders. Additionally, this methodology can be used for evaluating dissemination of lymphoma cells and for studying the clonal relationship between multiple (different locations) and consecutive (over time) lymphomas. Here we describe an integrated approach to assess clonality via analysis of Ig heavy chain (IGH), Ig kappa (IGK), TCR beta (TRB), and TCR gamma (TRG) gene rearrangements, based on the standardized multiplex PCRs as originally developed by the European BIOMED-2 consortium (currently named EuroClonality). The described protocol covers the pre-analytical phase of DNA isolation (from formalin-fixed paraffin-embedded and fresh tissues, body fluids, peripheral blood, and bone marrow), the analytical phase of PCR GeneScan analysis, and the post-analytical interpretation of the obtained profiles, following established guidelines.

Diagnostic role of urine human epididymis protein 4 in ovarian cancer.

Ovarian cancer is the 8th most common malignancy in women and the deadliest gynecological cancer. Due to the non-specific symptoms and the lack of effective diagnostic methods, late diagnosis remains the main barrier for improving the poor prognosis. Human epididymis protein 4 (HE4) is a protein overexpressed in ovarian cancer, but not in healthy individuals or benign conditions. The aim of this review article is to evaluate the laboratory aspect and potential clinical application of urine HE4. The methodology is presented, together with discussion on preanalytical, analytical and postanalytical phase of HE4 detection using urine. Moreover, we present the diagnostic role of urine HE4 in differential diagnosis, chemotherapy response, detection of recurrence and detection of low-malignant potential tumors. It has been found that urine HE4 presents as a promising, non-invasive tumor marker for detection and monitoring of ovarian cancer. However, standardization of the HE4 detection process is needed prior to implementation in clinical diagnostics.

Adrenal insufficiency - causes and laboratory diagnosis.

Adrenal insufficiency (AI) manifests as a clinical syndrome arising from either the direct impairment of adrenal glands, leading to primary AI characterized by deficiencies in glucocorticoids and mineralocorticoids, or adrenal cortex atrophy due to diminished adrenocorticotropic hormone (ACTH) stimulation, a consequence of hypothalamic and/or pituitary damage, resulting in secondary AI. The diagnosis of AI is based on clinical assessment and biochemical tests, including basal hormone level measurements and stimulation tests. In evaluating the results of laboratory tests, it is necessary to consider factors that may influence both pre-analytical and analytical phases, as well as the chosen methodology. Correct diagnosis of adrenal insufficiency and timely initiation of suitable replacement therapy are paramount. These steps are crucial not only for managing the condition but also to avert potentially life-threatening adrenal crises.

Preanalytical Phase Tumor Contaminants in Intraoperative Margins From Transoral Robotic Surgeries.

Tumor contaminants were incidentally noted in frozen section margins of oropharyngeal squamous cell carcinoma. To estimate the frequency of tumor contaminants in frozen section slides of patients who underwent surgery for pharyngeal cancer, and to characterize the surgical and pathologic context of these incidents. A retrospective search was conducted to identify pharyngeal resections from 2016 to 2022. Surgical pathology, operative reports, and frozen section slides were reviewed. Preanalytical phase tumor contaminants were defined as tumor contaminants that occurred in frozen section slides with or without occurrence in permanent slides. Eighty-one pharyngeal resections with intraoperative tumor bed margins for squamous cell carcinoma were identified. These included 308 tumor bed margins represented in 641 slides. Preanalytical contaminants occurred among 9 patients (11.1% of all and 21.4% of robotic surgeries) and in 3.8% of the 308 intraoperative tumor bed margins. A statistically significant association was found between contaminants and larger tumor size (Student t test, P = .04) and surgical approach (robotic versus open oropharyngectomy: Fisher exact test, P < .001). All patients with contaminants had intraoperative tumor disruption. Two frozen section deferrals (0.6%) and 2 discrepancies with final diagnosis (0.6%) attributed to contaminants were identified; however, clinical or surgical management was not affected in any patient. Preanalytical contaminants may cause confusion in intraoperative margin assessment. They are more likely to occur in margins of nonkeratinizing squamous cell carcinoma resected by transoral robotic surgery if there is intraoperative tumor disruption. Rarely, preanalytical contaminants lead to frozen section deferral or discrepancy with final diagnosis.

A-188 Modal Failure and Effects Analysis, FMEA methodology, as a strategy to increase patient safety

Abstract Background Patient safety during the clinical care process is considered a priority in healthcare. Failure Mode and Effects Analysis (FMEA) is a proactive and systematic method of process evaluation and is used to identifying where and how each phase of the analytical process could fail allowing the detection of the causes and the effects they produce on the quality of the results that are issued. A regular use of this tool makes possible to identify the most critical steps, propose improvement strategies and evaluate their impact. The aim of the study is to evaluate applicability of the FMEA tool to identify errors in the pre analytical, analytical, and post analytical phase of a clinical laboratory as well as the main causes and effects, to reduce them by proposing improvement strategies Methods For each phase into which the laboratory activity is divided, the frequency and type of errors that are made and their final consequences on the patient are evaluated. A risk index (NPR=OxDxS) is calculated for each error considering the frequency with which it occurs (O), the ease with which it is detected (D) and the severity of the consequences on the patient (S). Values goes from 1 (rarely) to 10 (often). Improvement actions are proposed for all errors with a risk index greater than 100 and this index is re-evaluated after the implementation of that improvement measures. This same analysis is performed for three times over the last 10 years (in 2014, 2019 and 2023). Results In FMEA analysis carried out in 2014, a total of 40 errors were identified in the pre-analytical phase (63.5% of the total), 12 in the analytical phase and 11 in the post-analytical phase. 50% of the total errors detected required improvement strategies because they had an NPR≥100 value. In the 2023 evaluation, a total of 27 errors were identified in the pre-analytical phase, 10 in the analytical phase, and 5 in the post-analytical phase but only 6 required improvement strategies, which represents an 80% reduction in the most critical errors for patient safety. However, the pre-analytical phase continues to be the most critical, as it continues to account for 64% of the total errors identified, including the lack of identification of the patient or sample and the inadequate prior preparation of the patient. In analytical and post-analytical phases, the NPR values obtained in 2023 decrease significantly over analysis carried out in 2014 and its not needed to apply improvement strategies. Automation and the IT tools significantly reduce the number of errors with high NPR values, but it is undoubtedly the involvement of service professionals that makes the difference over the years. Conclusions The use of the FMEA methodological tool allows the design of appropriate indicators to detect and reduce errors in the clinical laboratory. Its application as part of a good quality control allows a continuous improvement in the laboratory process and consequently a guarantee of quality for the patient

A-209 Preanalytical Phase Errors Constitute the Vast Majority of Errors in Clinical Laboratory Testing

Abstract Background Laboratory errors can occur during the preanalytical, analytic, or post-analytic phase of testing and may pose a considerable threat to patient safety. Studies have estimated that pre-analytical error encapsulates ∼45-68% of laboratory errors and occurs in up to 1.52% of specimens. However, limitations of previously published studies include the use of manual error detection, reliance on manual transcription, small study sizes, and exclusion of common errors. Herein, we aim to identify the types and frequency of errors occurring in each phase of clinical laboratory testing using a large retrospective dataset across a broad range of errors detected in clinical laboratories. Methods This study was performed in the Barnes-Jewish Hospital core laboratory which provides testing for a 1,400-bed tertiary care hospital and included all tests performed for clinical chemistry, special chemistry, toxicology, automated hematology, blood gas testing, coagulation, non-infectious serology, infectious disease serology, urinalysis, and send out testing between January 2022 and May 2023. Errors were compiled from two separate sources. The first source of errors was captured from the laboratory information system (LIS, Cerner). These errors were flagged manually by laboratory staff in real time. The second source of error was a daily report manually curated by a trained medial laboratory scientist as part of routine, laboratory operating procedures and standard workflow. Results There were ∼40,000,000 individual results from ∼11,000,000 specimens during the study period and 87,317 errors observed (∼0.8% of specimens). Of these errors, specimens that were hemolyzed sufficiently to impact result but still reportable were the majority (41,047, 47.2%). When excluding minimal hemolysis, there were 46,270 errors documented. Among these, 44,847 (97.0%) were in the preanalytical phase, 451 (1.0%) were in the analytical phase, and 972 (2.0%) occurred in the postanalytical phase. Subcategorization of preanalytical errors revealed that most of the errors were related to hemolyzed samples requiring results to be suppressed (n=19,701), quantity not sufficient samples (n=8,068), clotted specimens (n=5,840), collection errors (e.g., wrong tube type, n=5,780), not on ice (n=1,369) and IV fluid contamination (n=1,122). In the analytical phase, the causes of error were interfering substances (n=279), QC out of range (n=65), instrument problems (n=58) and reagent issues (n=49). Among the postanalytical errors, 581 were comment errors, 216 were results entry errors, 131 were comments errors with potential impact on patient care, and 44 were dilution errors. Conclusions This study demonstrates that the vast majority of lab errors (∼97.0%) occurring during the preanalytical phase. The high incidence of preanalytical errors, especially errors related to sample integrity implies a need for enhanced tools and training to minimizing errors from specimen collections, maintenance of sample stability, transportation, and processing.

A-057 Assessing Direct Renin Stability in EDTA Plasma Prior to Separation from Cells and Post-thaw

Abstract Background Renin is an enzyme secreted by the kidneys responsible for blood pressure regulation through the renin-angiotensin-aldosterone axis. Direct renin measurements are frequently used to investigate underlying causes of hypertension, including primary aldosteronism (PA), which is screened for using an aldosterone:renin ratio (ARR). Appropriate handling of renin samples in the preanalytical phase is critical, as cryoactivation of prorenin can occur when samples are refrigerated or cooled for extended periods of time, falsely elevating results. Manufacturer instructions for renin handling are often poorly defined and there is currently no consensus as to best handling practices. Two variables that frequently lead to renin sample rejections in our laboratory are time to centrifugation after collection and time kept at room temperature (RT). The objective of this study was to evaluate the stability of direct renin under ambient and freeze-thaw conditions in an effort to reduce test cancellations due to improper handling. Methods Plasma samples collected from five volunteers with consent in K2EDTA tubes were used for renin stability studies. Baseline renin samples were kept at RT for two hours after collection, centrifuged, measured, and subsequently frozen for post-thaw studies. To assess stability before separation from cells, samples kept at RT for two and four hours prior to centrifugation were assayed in triplicate for direct renin. For post-thaw stability studies, plasma samples were split into two aliquots each and frozen at -20⁰C for at least 24 hours, but no longer than 30 days. After removal from -20⁰C, one set of aliquots was thawed on the benchtop at RT and the second set was thawed in an RT water bath for up to one hour. Samples were centrifuged and assayed for direct renin in triplicate at baseline and six hours post-thaw. Direct renin was measured using the LIAISON XL chemiluminescent immunoassay (Diasorin). Bias was assessed after each treatment. The total allowable error (TEa) was ±2 pg/mL or ±20%. Results Measured renin concentrations ranged from 6.8-29.7 pg/mL. The percent bias in direct renin concentrations when comparing samples stored for two-hour and four-hour timepoints before centrifugation was 2.0% on average. Post-thaw studies comparing renin concentrations at the baseline and six-hour timepoints revealed an average percent bias of 13.1% and 12.2% for RT and water bath thawing methods, respectively. All samples tested were within the TEa. Conclusions Direct renin is stable in lavender K2EDTA tubes at RT for up to four hours, prior to centrifugation and separation from cells. Renin concentrations remained stable after storage at -20⁰C and thawing at RT for up to six hours, regardless of thawing method. By expanding direct renin stability criteria, we hope to reduce the number of cancellations due to preanalytical handling errors and prevent redundant phlebotomy for patients.

B-324 Pilot Study Result of EQA for Fecal Immunochemical Test for Hemoglobin Using a Novel Ready-to-Use Sample Material

Abstract Background The primary screening method for colorectal cancer is fecal immunochemical test (FIT) detecting human hemoglobin (Hb) in feces. There are several tests on the market both for automated analyzers and point-of-care testing (POCT). To ensure high quality results, the tests should be monitored with appropriate quality assessment procedures including participation in external quality assessment (EQA) programs. By participating in an EQA program using a stool-like material, clinical laboratories and POCT sites can fulfil the ISO 15189 requirements of monitoring the complete laboratory process from pre- to postanalytical phases in addition to the quantitative analytical phase of FIT. Here we present the first results of an international EQA pilot study for quantitative FIT using a novel ready-to-use stool-like material, performed by EQA provider Labquality. Methods 40 participants from 8 countries using 9 different FIT reagents were recruited for the pilot study performed in 2023. A set of artificial stool samples containing human hemoglobin uniformly was shipped to the participants at ambient temperature. The sample material is developed by HECTEF (Health Care Technology Foundation, Japan). The participants were instructed to collect the sample with their test specific sample collection kit and perform analysis according to the manufacturer’s instructions as a regular patient sample. Quantitative results (µg Hb/g feces) and qualitative interpretations (positive/negative) were reported in Labquality’s electronic platform LabScala. The quantitative target value was a method group consensus mean. A questionnaire regarding the usability of the sample material was sent to all participants. Results Sample S001 contained no Hb and all participants (40/40) reported a result corresponding to the lower detection limit of their test in use or a low numeric result most likely explained by unspecific background. All reported a negative interpretation. Sample S002 was a high positive sample for Hb. The measured value exceeded the upper detection limit of 4/9 tests (Exdia iFOB, Precision Biosensor; Fecal Occult Blood (iFOB) Neo, Boditech; FOB Test, VedaLab; NADAL FOB Quant test, Nal von Minden). The mean values and CV% were 116 µg/g and 8% for iFOBT, Aidian; 192 ug/g and 4% for Standard iFOB FIA, SD Biosensor; 144 µg/g and 45% for FOB assay kit FOB Gold, Sentinel Diagnostics (different clinical chemistry analyzers used); 91 µg/g and 26% for OC-Sensor FIT, Eiken Chemical. All participants responded a positive qualitative clinical interpretation. The majority of the responders on the feedback questionnaire (26/35) found the samples to be easy to use including comments of the sample being user-friendly and ready-to-use, resembling a patient sample and easy to apply with the test specific sample collection kit. Conclusions The fecal-like sample used in this Labquality’s EQA pilot study evaluates the complete analytical process including the preanalytical, analytical and postanalytical phases. An EQA scheme using this sample material is more compliant to ISO 15189 requirements compared to schemes where liquid or lyophilized samples are used. The new sample material used on this pilot study was positively received by most of the participants and it was compatible with all tests included in the study.

A-182 Applications of artificial intelligence optical character recognition in laboratory clerical functions offsetting staffing shortages and error reduction

Abstract Background The clinical laboratory profession has been dealing with a decade long, and now critical retention and staffing problem. The average national turnover rate for laboratory technicians is 17%, and the highest turnover rate exhibited for phlebotomists is 36%. While turnover rates have an impact on a laboratory, or hospitals budget, more importantly they have a substantial impact on quality and error rates, particularly in the pre-analytical stage of testing; with studies showing up to 65.09% of errors impacting the pre-analytical phase. Methods In an effort to remedy this high error rate, a meta-analysis was performed on paper order entry and clerical pre-analytical error, in parallel with performance and accuracy data of advanced optical character recognition driven by artificial intelligence and machine learning (AI OCR). Results AI OCR studies demonstrated an untrained accuracy percentage, to include handwriting of 91.08%, and when trained utilizing both relational and hierarchal logic data bases accuracy increased to 98.4%. The rate at which AI OCR processed and classified medical information was 3-4 pages per second. It is estimated that 99.9%-100% accuracy can be achieved with additional form field training and mapping. The level of accuracy and efficiency for laboratory paper order-entry utilizing AI OCR can also be increased with the addition of natural language processing and data recognition algorithms when combined with logic databases containing information such as medical record numbers, ICD-10 codes, and laboratory test compendiums. Conclusions The performance of this technology demonstrates a strong application to reduce the burden of clerical paper order entry, while addressing the 30.8% dissatisfaction rate regarding manual entry processes among lab professionals surveyed. Moreover, AI OCR clerical data classification, extraction and entry processes augmented with human verification steps examined, demonstrated overall accuracy of 99.99%. The application of AI OCR in laboratory pre-analytical processes has the potential to improve test order accuracy and efficiency, ultimately impacting the quality of patient care and operational costs for healthcare facilities. When examined through the lens of staff retention, studies show that 80% of laboratory employees feel that a workplace with the necessary tools and technology positively impacts their job satisfaction. While organizations investing in technologies that drive both job efficiency and satisfaction see a 125% return on investment through productivity. Demonstrating that the application of sophisticated technologies that both increase productivity and decrease error rates have a substantial impact on job satisfaction and ultimately retention. Although laboratory clerical data and order entry processes were examined for this meta-analysis, the aggregate data compiled showed that the application of AI OCR in clerical processes could also have a substantial impact on the 25.9% annual turnover rate for hospitals as a whole in the United States.

A-122 Evaluation of the Performance of the BD MiniDraw™ Capillary Blood Collection System Under Various Transport Conditions

Abstract Background Specimen transport is a vital component of the preanalytical phase. External factors such as temperature fluctuations, vibrations, shock, and prolonged transport times may negatively impact specimen integrity and compromise test results. A study was performed to evaluate the effects of temperature extremes and simulated transportation on specimen quality in the BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&amp;H and SST™ Capillary Blood Collection Tubes (BD MiniDraw™ H&amp;H, BD MiniDraw™ SST™). The BD MiniDraw™ Capillary Blood Collection System enables capillary blood collection by trained healthcare workers in non-traditional settings (i.e., retail pharmacies and clinics). Methods Sixteen adult participants were enrolled from the on-site Associate Sample Collection Program. Venous blood was collected via venipuncture into reference comparator and no-additive tubes. Venous blood from no-additive tubes was then pooled into a secondary container for aliquoting into BD MiniDraw™ SST™ and MiniDraw™ H&amp;H tubes. Thirty tubes per tube type were separated into 6 groups with storage and simulated transport conditions conducted in accordance with ASTM D7386-16 and ASTM D4169-22, as applicable: Group 1a: No transport, 2-8°C storage uncontrolled humidity, 49-52-hour storage; Group 1b: Air/road transport, 2-8°C storage uncontrolled humidity, 49-52-hour storage; Group 2a: No transport, 20-24°C storage, uncontrolled humidity, 5-7-hour storage; Group 2b: Road transport, 20-24°C storage, uncontrolled humidity, 5-7-hour storage; Group 3a: Road transport, 38-40°C storage, 90% relative humidity, 5-7-hour storage; Group 3b: Air/road transport, 38-40°C storage, 90% relative humidity, 49-52-hour storage Following clotting, centrifugation, and storage for the BD MiniDraw™ SST™ tubes, testing was performed for selected chemistry analytes (Albumin, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALKP), Blood Urea Nitrogen, Chloride, Calcium, Cholesterol, Creatinine, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Sodium, Total Bilirubin (TBIL), Total Protein, Triglycerides) on the Siemens Atellica® Solution. Testing was performed for hemoglobin/hematocrit on the Sysmex XN-1000 in the BD MiniDraw™ H&amp;H Tubes. Visual quality (barrier formation, hemolysis) and tube integrity (physical damage, blood leakage, cap removal, tube fit into adaptor) were also evaluated. Mean biases and confidence intervals within the specific analyte clinical acceptance limit for each group comparison was considered clinically equivalent. Results Clinical equivalence was demonstrated for all analytes for each group comparison except ALKP, ALT, HDL, LDL, TBIL and hematocrit for the extreme transport/storage conditions for Group 3b versus Group 3a. Complete barrier formation with acceptable visual hemolysis was noted in all specimens post transport. Tube integrity was maintained post transport as well. Conclusions Analytes were not impacted across a wide range of temperature and transport conditions. However, exposing samples to extreme high temperature, high humidity conditions may affect analyte performance. This reiterates the importance of monitoring conditions to ensure accurate test results. No impact to visual observations of sample quality and tube physical integrity was noted at different storage and transportation extremes.

Specimen Rejection in the Laboratory of a Secondary Medical Center in Egypt

Abstract Background Errors in Laboratory testing have a direct impact on patient safety, as it directly affects diagnosis and management. Most errors occur in the pre-analytical phase, which occurs outside the laboratory. This study aimed to investigate the laboratory specimen rejection rate and causes in the pre-analytical phase in the laboratory of petroleum medical center. Methods The present study was conducted at Petroleum medical center in Egypt from August 2022 to June 2023. The study included 1701 specimens, Checklist was used to collect data about specimens received at laboratory, it includes information about source of specimen, type of specimen, date and time specimen was collected and received at the laboratory, phlebotomist, specimen transports and storage conditions, whether a specimen was rejected, and the rejection reason. Results Out of 1701 specimens, 98 (5.76%) were rejected. Clotting of anticoagulated specimens caused 49 (50%) of the rejections, followed by insufficient volume and hemolysis accounting for 8 (8.1%) each. Most of the rejected specimens came from the Emergency department 16 (16.33%), intensive care unit 24 (24.94%) and medical ward “6” 27 (27.55%). About 12/69(17.39%) of the specimens collected by physicians were rejected compared to 65/1013 (6.42%) for nurses and 21/619 (3.39%) for laboratory technicians. Conclusions The specimen rejection rate in this study was around 98/1701(5.76%). Clotting of anticoagulated specimens was the most important cause for rejection.

Quality Control Circle Practices to Reduce Specimen Rejection Rates.

Quality assurance in laboratory testing significantly impacts patient care. The pre-analytical phase is particularly error-prone, contributing to around 70% of laboratory errors. High specimen rejection rates can delay diagnosis and treatment, cause patient discomfort, and increase healthcare costs. Quality Control Circles (QCC) have been introduced to medical institutions to improve process efficiency and reduce errors. This study aims to evaluate the effectiveness of QCC practices in reducing specimen rejection rates in a hospital clinical laboratory. A QCC initiative was implemented in the clinical laboratory from July 2021 to August 2022. The QCC comprised members from the clinical laboratory, nursing department, and administration. The initiative followed the PDCA (Plan-Do-Check-Act) cycle and involved multiple quality control methods, including flowchart analysis, Pareto analysis, and Fishbone diagrams. The effectiveness of the initiative was evaluated using statistical analyses of specimen rejection rates before and after implementation. The QCC initiative led to a significant reduction in specimen rejection rates. The monthly specimen rejection rate decreased from an average of 1.13% before the intervention to 0.27% after the intervention. The most significant factors contributing to specimen rejection were identified as lack of sample collection information and blood clotting. Targeted interventions, such as appointing specimen collection liaisons, establishing a quality control team, and providing training on blood collection procedures, were implemented. These measures resulted in a notable decrease in the proportion of rejected specimens due to the identified factors. The implementation of QCC practices effectively reduced specimen rejection rates in the hospital laboratory. The study highlights the importance of systematic quality control methods and targeted interventions in improving laboratory processes. The success of the QCC initiative demonstrates its potential for broader application in other healthcare settings to enhance quality and efficiency.

A Bibliometric Analysis of the Errors and Mistakes in the Medical Laboratory

Abstract Background: The increasing number/varieties of tests and rising demands are reasons for the increasing challenges to laboratory professionals, such as increasing workloads, maintaining turnaround time, and quality improvement. Furthermore, the laboratory faces many occupational hazards due to negligence or lack of knowledge regarding biosafety guidelines among the laboratory professionals. A laboratory involves mechanical, chemical, biological, and environmental components of activities, and errors/mistakes/ignorance in any of these disciplines create hazards and risks to people working inside the laboratory. Objective: We aimed to identify the types of errors, accidents, and ignorance in medical/clinical laboratories that have been published or presented worldwide. Materials and Methods: We performed a bibliometric analysis to search and analyze those studies which are published in different journals as articles or reviews, or published as books or chapters, and even, those presented as conference papers and short surveys. Results: The bibliometric analysis shows the pre-analytical phase as the most vulnerable to errors due to human errors and other activities outside the laboratory, which are beyond the control and preview of laboratories many times. A few studies suggest an increase in several tests and a lack of awareness among physicians while ordering the test as one of the reasons for the poor efficiency of laboratory services. Similarly, ignorance of the safety measures leads to occupational hazards among laboratory professionals. Conclusion: The study recommends focusing on the pre-analytical phase and providing awareness to clinicians about the tests conducted by the respective laboratories. This study also highlights that errors in the laboratory should be published for future records and learning.

Establishment of Preanalytical Quality Indicators and Current Status of Preanalytical Phase Laboratory Performance Monitoring in the Clinical Laboratories in Korea

Establishment of Preanalytical Quality Indicators and Current Status of Preanalytical Phase Laboratory Performance Monitoring in the Clinical Laboratories in Korea

Dihydrorhodamine-123 flow cytometry method: time for substantial revision in technical procedure.

The dihydrorhodamine 123 assay is generally applied to measure the production of intracellular reactive oxygen species in neutrophils using flow cytometry and is considered a diagnostic evaluation for chronic granulomatous disease. In fact, there is a broad range of variables that can directly or indirectly affect test results, either individually or collectively. It is therefore crucial to identify the ideal requirements to achieve reliable results as well as using these requirements to provide standard operating procedures that should be taken into account. Therefore, we focus on aligning optimum results by comparing preanalytical and analytical phases that influence test results, such as the effect of various anticoagulants, transport and maintaining temperature (24°C or 4°C) of samples, test prime run time, appropriate solution concentrations, and effect of incubation temperature (24°C or 37°C) during the test run.

Urine Sample Handling in Laboratory—Process Reengineering is the Need of the Hour

Background and Aims: Monitoring and a continual improvement of turnaround time (TAT) in urine examination and reporting is essential for improved management of laboratory quality as well as ensuring patient satisfaction. TAT can be impacted by multiple factors, some of which appear to be beyond the control of laboratory, especially the preanalytical phase of urine examination such as specimen collection, transportation and sample preparation. The aim of the study was to compare the preanalytical variables like TAT for transportation and incidences of spill between our current urinalysis workflow process and the new urinalysis workflow process using a pneumatic chute-compatible closed urine collection system. Materials and Methods: This observational prospective study was conducted on 4/9/23 from 9 am to 4 pm at the laboratory of Apollo Main Hospital, Chennai. Pneumatic chute compatible closed urine collection cup was given to the patients in Group-A and normal screw cap containers which we are currently using were given to the patients in Group-B. Once the urine samples were collected in the respective containers, they were transported to the laboratory using pneumatic chutes for Group-A samples and manual carry for Group-B samples. Analysis of transportation time using the new collection method (Group-A) when compared with the current method of practice (Group-B) was done. The incidence of spillage was also monitored. Results: A significant improvement was noticed in the transportation process and spill incidence with closed collection devices through the pneumatic chute. Conclusion: To conclude, the implementation of pneumatic chute compatible closed collection tubes for urine improves the transportation and processing time, eliminates the manual carry of urine samples, eliminates the incidences of leakage and spillage, reduces errors and reduces the exposure of urine to healthcare workers, thereby leading to significant improvement in patient care, patient experience and staff satisfaction.

SFBC Working Group on sources of errors in laboratory medicine: objectives and key areas of work

Laboratory medicine plays a crucial role in patient care, contributing to approximately 70% of clinical decisions. In collaboration with clinicians, laboratory medicine specialists perform analyses that are useful for diagnosis, screening and prevention. Laboratories are known for their efficiency, which is reached through a rigorous quality system. However, errors can occur, especially given the complexity of the total testing process. These errors may lead to severe consequences, such as incorrect diagnoses or delays in treatment. Errors can occur at every stage of the total testing process, those related to the pre-analytical phase being the most prevalent. To reduce medical errors related to laboratory processes, it is essential to provide training for medical and paramedical staff, optimize production automation, and leverage technological advancements. These considerations have led to the creation of a French Working Group on Sources of Errors in Laboratory Medicine, under the aegis of the French lean society of clinical chemistry and laboratory medicine (Société Française de Biologie Clinique - SFBC). The objectives of this working group are to produce an educational handbook on sources of errors in laboratory medicine, provide training for clinical chemists, and conducting applied research projects to better understand the mechanisms behind specific errors. Ultimately, the aim is to minimize errors and enhance the quality of laboratory tests.