Performance Of Clinical Laboratories Research Articles

Quality and resilience of clinical laboratories in Rwanda: a need for sustainable strategies

ABSTRACT Background Quality healthcare is a global priority, reliant on robust health systems for evidence-based medicine. Clinical laboratories are the backbone of quality healthcare facilitating diagnostics, treatment, patient monitoring, and disease surveillance. Their effectiveness depends on sustainable delivery of accurate test results. Although the Strengthening Laboratory Management Towards Accreditation (SLMTA) programme has enhanced laboratory quality in low-income countries, the long-term sustainability of this improvement remains uncertain. Objective To explore the sustainability of quality performance in clinical laboratories in Rwanda following the conclusion of SLMTA. Methods A quasi-experimental design was adopted, involving 47 laboratories divided into three groups with distinct interventions. While one group received continuous mentorship and annual assessments (group two), interventions for the other groups (groups one and three) ceased following the conclusion of SLMTA. SLMTA experts collected data for 10 years through assessments using WHO’s StepwiseLaboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist. Descriptive and t-test analyses were conducted for statistical evaluation. Results Improvements in quality were noted between baseline and exit assessments across all laboratory groups (mean baseline: 35.3%, exit: 65.8%, p < 0.001). However, groups one and three experienced performance declines following SLMTA phase-out (mean group one: 64.6% in reference to 85.8%, p = 0.01; mean group three: 57.3% in reference to 64.7%, p < 0.001). In contrast, group two continued to enhance performance even years later (mean: 86.6%compared to 70.6%, p = 0.03). Conclusion A coordinated implementation of quality improvement plan that enables regular laboratory assessments to pinpoint and address the quality gaps is essential for sustaining quality services in clinical laboratories.

Navigating Next-Generation Sequencing Laboratory Developed Tests: A Critical Look at Proficiency Testing, US Food and Drug Administration Regulations, and Clinical Laboratory Performance.

Navigating Next-Generation Sequencing Laboratory Developed Tests: A Critical Look at Proficiency Testing, US Food and Drug Administration Regulations, and Clinical Laboratory Performance.

Sigma metric used to evaluate the performance of haematology analysers: choosing an internal reference analyser for the laboratory

ABSTRACTIntroductionThe sigma metric offers a quantitative framework for evaluating process performance in clinical laboratories. This study aimed to evaluate the analytical performance of automated analysers in haematology laboratories, using the sigma metric to choose the best analyser as an internal reference analyser.Materials and Methodsinternal quality control (IQC) data were collected for 6 months from SNCS, and the sigma value was calculated for 9 haematology analysers in the laboratory.ResultsFor the normal control level, a satisfactory mean sigma value ≥3 was observed for all of the studied parameters of all automated analysers. For the low control level, platelet (PLT) count by Instrument (Inst.) G performed poorly, with a mean sigma value <3. Inst. H, with all parameters’ sigma values >4, performed best and was chosen as the internal reference analyser.ConclusionThe sigma metric can be used as a guide to choose the QC strategy and plan QC frequency. It can facilitate the comparison of the same assay performed by multiple systems.

A-079 Analytical Assessment of Abbott’s SigmaSTRONG assays on the Alinity c and ARCHITECT c Systems

Abstract Introduction Clinical chemistry assays are responsible for 57% of all core lab testing (1) as a result there is an ever-increasing demand to improve the accuracy and reliability of results in clinical laboratories. Sigma metrics have proven to be powerful tools for quantitatively evaluating clinical assay and instrument performance. The Sigma performance of an assay is calculated from the formula (TEa-Bias)/CV. To address modern clinical laboratory performance requirements Abbott has developed and launched a portfolio of clinical chemistry assays under the brand name Sigma STRONG ™ which claim to achieve world class performance with a Sigma Metric of ≥6 for 86% of products within this portfolio (2). The purpose of this study is to assess these assays against Abbott’s products requirement (PR) for precision and method comparison. Methods Assay precision (%CV) studies were performed based on guidance from CLSI EP05-A3 using 2–3 levels of commercially available serum-based control material. Method Comparison (MC) studies were performed based on guidance from CLSI EP09-A3 using the Passing-Bablok regression method. Assays under investigation were assessed for performance on either the Abbott Alinity c or Abbott ARCHITECT c systems. Results Conclusion This study has confirmed the sigma STRONG ™ assays, under assessment, have met Abbott’s product requirement for both precision and method comparison.

A comparative analysis of Sigma metrics using conventional and alternative formulas

Background and AimThe Six Sigma approach, employing Sigma Metrics (SM), is commonly used to evaluate analytical performance in clinical laboratories. However, there is ongoing debate regarding the suitability of the conventional SM formula, which incorporates total allowable error (TEa) and bias. To address this, an alternative formula based on within-subject biological variation (CVI) as the tolerance range (TR) has been proposed. The study aimed to calculate and compare SM values using both formulas. Material and MethodsTwenty clinical chemistry parameters were evaluated, and SM values were calculated using conventional formula with two TEa goals and the alternative formula. Intermediate precision (CVA%) values were obtained from internal quality control data, while bias values were derived from external quality assessment reports. ResultsThe results showed that using the conventional formula, 11 SM values based on CLIA TEa goals and 21 SM values based on BV TEa goals were deemed unacceptable (SM < 3). Additionally, 22 SM values calculated using the alternative formula were below 3. ConclusionThe choice of TR had a substantial impact on the assessed analytical performance. Laboratories should carefully consider the appropriateness of each approach based on their specific quality objectives, analyte characteristics, and laboratory operations.

Serotonin secretion by blood platelets: accuracy of high-performance liquid chromatography-electrochemical technique compared with the isotopic test and use in a clinical laboratory

BackgroundMild secretion defects are the most frequent and challenging blood platelet disorders to diagnose. Most δ-granule secretion tests lack validation, are not quantitative, or have unreliable response to weak platelet agonists. ObjectivesTo compare platelet serotonin secretion by HPLC-electrochemical detection technique (HPLC-ECD) with the reference isotopic test (3H-5-HT), evaluating its performance in clinical laboratories. MethodsThe assay validation followed STARD-2015 recommendations. HPLC-ECD measured the nonsecreted serotonin remaining in platelet pellets after aggregation, comparing it with the reference 3H-5-HT assay. We studied subjects with inherited and aspirin-induced blood platelet disorders and assessed the HPLC-ECD operation for routine clinical diagnosis. ResultsCalibration curves were linear (R2 = 0.997), with SD for residuals of 3.91% and analytical sensitivity of 5ng/mL. Intra- and interassay imprecision bias ranged between −8.5% and 2.1% and −9% and 3.1%, respectively. Serotonin recovery and stability were >95%, and the variability range of measurements was −5.5% to 4.6%. Statistical differences detected between tests were biologically irrelevant, with bias of 1.48% (SD, 8.43) and CI agreement of −18% to 15%. Both assays distinctly detected platelet secretion induced by 10 μM epinephrine and 4 μmM adenosine diphosphate. However, HPLC-ECD is quantitative and more sensitive to low serotonin content in blood platelets. Reference cutoffs for each agonist were determined in 87 subjects. Initially, the HPLC-ECD requires relatively expensive equipment and trained operators but has remarkably cheap running costs and a turn-around time of 24-36 hours. We have used this diagnostic tool routinely for >8 years. ConclusionHPLC-ECD assay for platelet serotonin secretion is highly accurate, has advantages over the reference 3H-5-HT test, and is suitable as a clinical laboratory technique.

Possible Impact Factors for Poor Quality Management of Clinical Laboratory Performance in Wad Medani City, Sudan

Possible Impact Factors for Poor Quality Management of Clinical Laboratory Performance in Wad Medani City, Sudan

Consolidation Of the Quality Indicator System for Clinical Laboratory Performance Improvement

Consolidation Of the Quality Indicator System for Clinical Laboratory Performance Improvement

Prioritization of the factors affecting the performance of clinical laboratories using the AHP and ANP techniques

Prioritization of the factors affecting the performance of clinical laboratories using the AHP and ANP techniques

External quality assessment for detection of methylated Syndecan 2 (SDC2) in China.

Detection of Syndecan 2 (SDC2) methylation in stool DNA is a novel method for the auxiliary diagnosis of early colorectal cancer (CRC). Currently, this method has been widely applied; however, its accuracy and reliability have not been determined. The objective of this pioneering study was to evaluate the performance of clinical laboratories in China for their ability to detect SDC2 methylation from stool DNA. We generated a sample panel consisting of clinical and cell samples. The clinical samples were stool specimens from patients with or without CRC, including four positives (prepared by serial dilution from one stool specimen), one negative and one interferential sample. Two cell samples, with positive or negative methylated SDC2, were used as controls. The panel was distributed to 32 clinical laboratories for analysis of SDC2 methylation, and the results were compared and scored. The sample panel was compatible with commercially available assays and it showed appropriate stability to be an external quality assessment material. There were four false results; one hospital laboratory and one commercial diagnostic laboratory had a false-positive and a false-negative result, respectively, and one commercial diagnostic laboratory had both a false-positive and false-negative result. Among the 32 participating laboratories, 29 (90.62%) obtained an acceptable or better performance score, while 3 (9.38%) laboratories required improvement. Our results demonstrate that the detection of SDC2 methylation from stool DNA was satisfactory in China. Additionally, the importance of external quality assessment was highlighted for monitoring the performance of clinical laboratories.

Langerhans cell histiocytosis. Advances in pathogenesis and clinical practice

Langerhans cell histiocytosis (LCH) is a type of myeloid neoplasia that can affect different organs or tissues and exhibits substantial variability in its clinical presentation and biological behaviour, so it may mimic different diseases. Performance of different clinical assessments and laboratory and imaging tests is recommended to determine the extent of involvement, which may be of a single location or multisystemic, and the presence or absence of dysfunction in risk organs, such as the haematopoietic system, liver and spleen. The diagnosis must be confirmed by histological examination of a biopsy sample. Molecular tests have identified mutations in the mitogen-activated protein kinase (MAPK) pathway, which has expanded treatment options. The diagnosis is complex and there is controversy regarding the management of certain cases. Treatment recommendations depend on the location of the lesions and the extent of involvement. International collaborative studies have demonstrated the effectiveness of prolonged combination therapies such as vinblastine and prednisone in severe or multisystemic forms, and anti-inflammatory drugs such as indomethacin and other cytostatic combinations have proven beneficial. Langerhans cell histiocytosis is a good example of the importance of precision medicine and the benefit of identifying molecular targets, common to different neoplasms, to develop new therapies. MAPK pathway inhibitors offer an alternative treatment option in refractory cases and neurodegenerative forms of LCH. Molecular testing can contribute to the prognosis, treatment and follow-up of LCH, especially in severe forms of disease.

Histiocitosis de células de Langerhans. Avances en la patogenia y práctica clínica

Langerhans cell histiocytosis (LCH) is a type of myeloid neoplasia that can affect different organs or tissues and exhibits substantial variability in its clinical presentation and biological behaviour, so it may mimic different diseases. Performance of different clinical assessments and laboratory and imaging tests is recommended to determine the extent of involvement, which may be of a single location or multisystemic, and the presence or absence of dysfunction in risk organs, such as the haematopoietic system, liver and spleen. The diagnosis must be confirmed by histological examination of a biopsy sample. Molecular tests have identified mutations in the mitogen-activated protein kinase (MAPK) pathway, which has expanded treatment options. The diagnosis is complex and there is controversy regarding the management of certain cases. Treatment recommendations depend on the location of the lesions and the extent of involvement. International collaborative studies have demonstrated the effectiveness of prolonged combination therapies such as vinblastine and prednisone in severe or multisystemic forms, and anti-inflammatory drugs such as indomethacin and other cytostatic combinations have proven beneficial. LCH is a good example of the importance of precision medicine and the benefit of identifying molecular targets, common to different neoplasms, to develop new therapies. MAPK pathway inhibitors offer an alternative treatment option in refractory cases and neurodegenerative forms of LCH. Molecular testing can contribute to the prognosis, treatment and follow-up of LCH, especially in severe forms of disease.

External Quality Assessment for Severe Acute Respiratory Syndrome Coronavirus 2 RNA Detection in Chongqing, China.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a huge threat to public health. Therefore, clinical laboratories must have the ability to detect SARS-CoV-2 RNA. With the enhanced detection in Chongqing, many laboratories rapidly implemented assays for the molecular detection of SARS-CoV-2 based on real-time reverse transcription polymerase chain reaction (rRT-PCR) assays. This study aimed to improve the detection capabilities of clinical laboratories by evaluating their performance for SARS-CoV-2 RNA detection through the external quality assessment (EQA) programs of 2020 in Chongqing to contribute to the prevention of this epidemic. The EQA panels consist of eight positive samples with concentrations within 2.7 - 5.0 log10 copies/mL quantified by digital PCR and two negative samples with other human coronaviruses clinically validated by four commercial assays. All 21 samples from four rounds were distributed to the participating laboratories through cold-chain transportation. Depending on the results from each sample, laboratories were asked to use one or two assays to detect SARS-CoV-2 RNA. Test results and raw data were also required. All data were evaluated, and the testing performance of commercial assays was compared. For the rounds, all laboratories used commercial assays. Four rounds of EQA programs were performed, and the percent agreements of participants were 97.5% (39/40), 97.5% (39/40), 98.9% (88/89), 100.0% (131/131). Only three false negative results and one false positive result were obtained. Statistical significance in the Ct values of the ORF region and N region of SARS-CoV-2-RNA was found by using one-step, one-step concentration, and magnetic bead methods (p < 0.05). The Ct values of the ORF region of SARS-CoV-2-RNA in P5 and P6 were significantly different in the different batches of reagent A (p < 0.05). The ORF region of SARS-CoV-2-RNA was not detected in a batch of reagent B. The majority of laboratories in Chongqing have reliable diagnostic ability for SARS-CoV-2 detection. Our data emphasized the importance of EQA for monitoring the performance of clinical laboratories. However, clinical laboratories must first effectively evaluate the performance of reagents prior to their use.

Performance of International AIDS Vaccine Initiative African clinical research laboratories in standardised ELISpot and peripheral blood mononuclear cell processing in support of HIV vaccine clinical trials.

BackgroundStandardisation of procedures for performing cellular functional assays across laboratories participating in multicentre clinical trials is key for generating comparable and reliable data.ObjectiveThis article describes the performance of accredited laboratories in Africa and Europe on testing done in support of clinical trials.MethodsFor enzyme-linked immunospot assay (ELISpot) proficiency, characterised peripheral blood mononuclear cells (PBMCs) obtained from 48 HIV-negative blood donors in Johannesburg, South Africa, were sent to participating laboratories between February 2010 and February 2014. The PBMCs were tested for responses against cytomegalovirus, Epstein Barr and influenza peptide pools in a total of 1751 assays. In a separate study, a total of 1297 PBMC samples isolated from healthy HIV-negative participants in clinical trials of two prophylactic HIV vaccine candidates in Kenya, Uganda, Rwanda and Zambia were analysed for cell viability, cell yield and cell recovery from frozen PBMCs.ResultsMost (99%) of the 1751 ELISpot proficiency assays had data within acceptable ranges with low responses to mock stimuli. No significant statistical difference were observed in ELISpot responses at the five laboratories actively conducting immunological analyses. Of the 1297 clinical trial PBMCs processed, 94% had cell viability above 90% and 96% had cell yield above 0.7 million per mL of blood in freshly isolated cells. All parameters were within the predefined acceptance criteria.ConclusionWe demonstrate that multiple laboratories can generate reliable, accurate and comparable data by using standardised procedures, having regular training, having regular equipment maintenance and using centrally sourced reagents.

FRAMEWORK DEVELOPMENT FOR DYNAMIC SYSTEM VALIDATION

Validation is one of the most important stages of modeling, and it is a necessity before utilizing the model for further analyses. Especially for the studies that start with conceptual models, the validation process is more complex than others. In this study, we used a multi-methodology approach to develop a framework to support the conceptual model development and validation in System Dynamics (SD) modeling. In the proposed framework, we integrated methods from SD methodology with methods from the Analytic Network Process (ANP). The proposed framework was then used for clinical laboratory performance analysis. The purpose was to use the proposed framework to conduct structural validity of the SD model, to prioritize Clinical Laboratory (CL) performance indicators, and capture their relations. Results indicate that the proposed framework can be used to generate an enriched and validated conceptual model for a CL performance system that can be useful for healthcare decision-makers. Also, the proposed multi-methodology framework can be applied to any complex systems to validate the conceptual models.

Evaluation of clinical biochemistry laboratory performance using sigma metrics

Producing a reliable, reproducible, accurate, timely, and correctly interpreted test results by clinical laboratory is very important, since physicians’ decisions mostly depends on it for screening, diagnosis and monitoring diseases. To provide quality report, routinely in all clinical laboratories internal quality control (IQC) and external quality assessment (EQA) programs are done which helps to evaluate and continuously improve analytical quality. Recently new quality assessment (QA) systems, six-sigma became more popular because it offers a different approach to problems. Sigma metrics allow comparison of different processes with each other and thus improving the quality of testing processes. This study was done to evaluate clinical chemistry laboratory performance using sigma metrics. Keywords: Internal quality control, External quality assessment programs, Laboratory, Sigma metrics, Six-sigma.

Analysis of performance of clinical biochemistry laboratory using Sigma metrics and Quality Goal Index

BackgroundUnreliable and ingenuine results issued by clinical laboratories have serious consequences for the patients. Sigma metrics is a standardized tool for Quality assessment for test performance in a laboratory. ObjectiveTo evaluate the performance of routine biochemistry laboratory at MMIMSR, Mullana in terms of Sigma metrics and Quality Goal Index. Material and methodsThis cross sectional study evaluated performance of 14 routine chemistry parameters using retrospective Internal Quality Control data of two levels on Siemens Dimension Rxl from Feb to Jul 2019 for CV% and EQAS reports from CMC, Vellore for Bias%. Sigma metrics was calculated using total allowable error targets as per CLIA and Biological Variability database guidelines. ResultsFor level-2 IQC; TG, Chol, ALP showed excellent performance with σ ​> ​6 while σ ​< ​3 was observed for AST, Total Protein, Glucose, BUN and ALT using CLIA guidelines while in IQC Level-3 poor performers were only BUN and ALT with Ca, TG and Chol showing σ ​> ​6. Further by using Biological Variability data guidelines; 10 parameters of IQC Level-2 and 5 of IQC level-3 were poor performers with σ ​< ​3. ConclusionSigma metrics is an excellent tool for performance analysis of tests performed in a clinical laboratory. Lack of precision in terms of CV% was seen for majority of the poor performers. Total allowable error targets using Biological Variability data revealed σ ​< ​3 for 10 parameters while using CLIA guidelines σ ​< ​3 was seen for only 5 parameters of IQC level-2.

Spanish society of laboratory medicine external quality assurance programmes: evolution of the analytical performance of clinical laboratories over 30 years and comparison with other programmes.

The purpose of this study is to understand the evolution of the analytical performance of the laboratories participating in the Spanish society of laboratory medicine (SEQCML) external quality assurance (EQA) programmes during its 30 years of operation and to compare it with the performance of other EQA programmes to establish whether the results are similar. The results obtained during this period are evaluated by applying the biological variability (BV) and state of the art-derived quality specifications. In addition, the results are compared with those obtained by other EQA programme organisations. It is noted that the laboratories participating in the EQA-SEQCML programmes have improved their performance over 30 years of experience and that the specifications derived from biological variation are achievable. It is difficult to compare EQA programmes, due to lack of accessibility and the differences in the design of these programmes (control materials, calculations used and analytical specifications established). The data from this study show that for some biological magnitudes the results obtained by the programmes are not yet harmonised, although efforts are being made to achieve this. Organisers of EQA programmes should also join the harmonisation effort by providing information on their results to enable comparison.

Evaluation of biochemical methods performance in clinical laboratories: is this performance suitable for clinical application?

Evaluation of biochemical methods performance in clinical laboratories: is this performance suitable for clinical application?

Application of Sigma Metrics for Evaluating the Analytical Performance of Thyroid Profile and Cortisol in Clinical Biochemistry Laboratory

Introduction: Now-a-days quality is the key aspect of clinical laboratory services. The six sigma metrics is an important quality measurement method for evaluating the performance of the clinical laboratory. Aim: To assess the analytical performance of clinical biochemistry laboratory by utilising thyroid profile and cortisol parameters from Internal Quality Control (IQC) data and to calculate sigma values. Materials and Methods: Study was conducted at Clinical Biochemistry Laboratory, Dhiraj General Hospital, Piparia, Gujarat, India. Retrospectively, IQC data of thyroid profile and cortisol were utilised for six subsequent months (July to December 2019). Coefficient of Variation (CV%) and bias were calculated from IQC data, from that the sigma values were calculated. The sigma values &lt;3, &gt;3 and &gt;6 were indicated by poor performance procedure, good performance and world class performance, respectively. Results: The sigma values were estimated by calculating mean of six months. The mean sigma value of Thyroid Stimulating Hormone (TSH) and Cortisol were &gt;3 for six months which indicated the good performance. However, sigma value of Triiodothyronine (T3), Tetraiodothyronine (T4) were found to be &lt;3 which indicated poor performance. Conclusion: Six sigma methodology applications for thyroid profile and cortisol was evaluated, it was generally found as good. While T3 and T4 parameters showed low sigma values which requires detailed root cause analysis of analytical process. With the help of six sigma methodology, in clinical biochemistry laboratories, an appropriate Quality Control (QC) programming should be done for each parameter. To maintain six sigma levels is challenging to quality management personnel of laboratory, but it will be helpful to improve quality level in the clinical laboratories.