Internal Quality Control Research Articles

Auditor’s opinion, future abnormal cash holdings and internal control quality: evidence from an Asian market in pre-COVID-19 and post-COVID-19 pandemic

PurposeThe present study aims to investigate the impact of the auditor’s opinion and internal control quality (ICQ) on future abnormal cash holdings for companies listed on the Tehran Stock Exchange (TSE).Design/methodology/approachInformation about 216 companies in 2014–2021 was examined. This study used the absolute value of abnormal cash holdings to test the research hypotheses. However, future extra abnormal cash holdings and future deficit abnormal cash holdings were also tested. Modified multiple regression method and ordinary least squares (OLS) were used. The present study also applied the generalized method of moments (GMM) for endogeneity concerns.FindingsThe results showed that an unqualified audit opinion negatively and significantly affects a firm’s future abnormal cash holdings. Moreover, ICQ significantly strengthens the impact of an unqualified audit opinion on a firm’s future abnormal cash holdings. These results remained robust even after several robustness tests. This study tested the robustness of results through data division into the pre-COVID-19 and post-COVID-19 years. The test confirmed previous findings; however, the strength of these effects decreased in post-COVID-19 years.Originality/valuePrevious studies could not answer how an auditor’s opinion affects a company’s future abnormal cash holdings. Moreover, no empirical study has addressed the moderator role of ICQ in the relationship between unqualified audit opinion and future abnormal cash holdings. This study helps stakeholders evaluate the performance of firms more accurately, especially in any global health crisis such as the COVID-19 pandemic and similar crises. Combined with the research findings from developed countries, this study can potentially contribute to the global community’s efforts in advancing international objectives.

The Concept of Educational Quality Management; Review of Private Islamic Educational Institutions

This study aims to examine the concept of educational quality management in educational institutions, especially in Islamic education at Batam. The method used is qualitative with literature studies from reference books, journals, and relevant archive documents. Data were analyzed descriptively-analytical with a critical approach. The results of the study indicate that educational quality management manages all educational resources to produce services that meet or exceed customer needs. The basic strategies needed include problem identification, application of quality philosophy, continuous improvement, and stakeholder involvement. In conclusion, educational quality management in Islamic institutions must be implemented comprehensively and integrated to achieve customer satisfaction and continuous performance improvement. Internal quality control systems play an important role in ensuring that results are in accordance with standards. This study offers quality management strategies that are relevant to the context of Islamic education in Indonesia as well as a comprehensive management approach that involves all institutional aspects.

PIRCHE-II: a new tool to predict rejection in cardiac transplantation?

Abstract Aim This retrospective observational study aims to compare patients diagnosed with antibody-mediated or cell-mediated rejection with patients without episodes of rejection and study any predictors of rejection at follow-up with particular attention to PIRCHE-II scores. Materials and Methods We performed a retrospective evaluation of prospectively collected data of heart transplant patients from January 2022 to August 2023, at a single hospital. Preoperative, intraoperative and postoperative parameters are collected anonymously in our institutional database used for internal quality control. The primary endpoint was the incidence of rejection in one of three control endomyocardial biopsies. As pre-operative data, age, sex, BSA, blood group mismatch, risk such as dyslipidemia, hypertension, diabetes, peripheral vascular disease, COPD, previous cardiac surgery, PRA, ischemia time and post-operative infections. We evaluated patients at a mean follow-up of 106 (78 – 180) days. In patients who tested positive for cell-mediated or antibody-mediated rejection, the PIRCHE-II score was calculated. Results There were 45 patients with no diagnosis of rejection and they were aged 61 [50-65]; 22.2% were women, with a mean BSA of 1.87 ± 0.19. 22.2% had a blood type mismatch. They had a mean PIRCHE-II of 111.88 ± 43.6. There were 15 patients diagnosed with rejection and they were 63 years old [52 – 66]; 20.0% were women, with a mean BSA of 1.84 ± 0.23. 13.3% had a blood type mismatch. They had a mean PIRCHE-II of 113.70 ± 33.90. In multivariable analysis, the main predictors of rejection were plasma transfusions [OR 0.053, 95% CI, p=0.02], post-operative infections [OR 0.076, 95% CI, p=<0, 02] and the PIRCHE – II [OR 3.284, 95% CI, p=0.04]. The mean PIRCHE-II of patients who presented antibody-mediated or cell-mediated rejection was 113.70 ± 33.90 and that of patients who did not present any rejection was 111.88 ± 33.90; Conclusion According to the results obtained, the PIRCHE-II algorithm could be a tool in immunological risk stratification in patients undergoing cardiac transplantation. It is necessary, however, to apply PIRCHE-II to a larger number of patients and should also be considered in light of other factors such as the immunological status of the recipients, the immediate post-operative course (infections, CMV reactivation, blood component transfusions), which could constitute an immunological trigger and patient compliance in immunosuppressive therapy.Patients' featuresResuts

The accountability system for operation and investment and audit quality of state-owned enterprises

Based on the accountability system for illegal operation and investment of state-owned enterprises (SOEs), this paper uses A-share listed companies in China from 2013 to 2021 as a research sample to empirically test the impact of operation and investment accountability on the audit quality of firms. The results show that after the implementation of the accountability system, the audit quality of SOEs is significantly improved, and the results hold after a series of robustness checks. Mechanism tests suggest that reducing misconducts of managers, inhibiting earnings management and improving the quality of internal control can explain the effects of operation and investment accountability. Heterogeneity analyses suggest that the positive effect of operation and investment accountability on the audit quality of SOEs is more pronounced for firms in poor business environment, with low level of digital transformation and low degree of mixed-ownership reform. Further tests on economic consequence suggest that operation and investment accountability increase economic value added of state-owned assets by improving the effectiveness of auditing supervision. This paper extends the stream of literature on SOEs' auditing from the perspective of accountability, and provides practical implications on improving the quality of government monitoring measures and promoting the update of governance capacity and governance system.

MRD Detection in B-Cell Non-Hodgkin Lymphomas Using Ig Gene Rearrangements and Chromosomal Translocations as Targets for Real-Time Quantitative PCR and ddPCR.

Minimal residual disease (MRD) diagnostics is of high clinical relevance in patients with indolent B-cell non-Hodgkin lymphomas (B-NHL), B-cell chronic lymphocytic leukemia (CLL), and multiple myeloma and serves as a surrogate parameter to evaluate treatment effectiveness and long-term prognosis. Real-time quantitative PCR (RQ-PCR) targeting circulating lymphoma cells is still the gold standard for MRD detection in indolent B-NHL and currently the most sensitive and the most broadly applied method in follicular lymphoma (FL) and mantle cell lymphoma (MCL). Alternatively, droplet digital PCR (ddPCR) can be used for MRD monitoring in multiple myeloma, mantle cell lymphoma, CLL, and FL with comparable sensitivity, accuracy, and reproducibility.The most broadly applicable MRD target in B-NHL is the junctional regions of the rearranged immunoglobulin heavy (IGH) and light chain genes. Complete and incomplete IGH and additionally IG kappa light chain rearrangements can be used as targets for MRD. Next-generation sequencing (NGS) of IG-rearrangements (IG-NGS) as new sequencing-based technology can overcome the limitation of PCR-based approaches and has a potential for higher sensitivity. Chromosomal translocations like the t(14;18)(q32;q21) translocation associated with IGH::BCL2 fusion in FL and t(11;14)(q13;q32) translocation in MCL leading to the IGH::CCND1 fusion can be used as MRD target in selected lymphoma subtypes. In patients with CLL, both flow-cytometry and RQ-PCR are equally suited for MRD assessment as long as a sensitivity of 10-4 is achieved.MRD diagnostics targeting the IG loci is complex and requires extensive knowledge and experience because the junctional regions of each clonal rearranged gene have to be identified before the patient-specific PCR assays can be designed for MRD monitoring. In addition, the presence and load of somatic hypermutation within the rearranged IGH gene occurring during B-cell development of germinal center and post-germinal center B-cell lymphomas may hamper appropriate primer binding leading to false-negative results. The translocations mentioned above have the advantage that consensus forward primers and probes, both placed in the breakpoint regions of chromosome 18 in FL and chromosome 11 in MCL, can be used in combination with a reverse primer placed in the IGH joining region of chromosome 14. PCR-based methods using allele-specific primers can reach a high sensitivity of up to 10-5. This chapter provides all relevant background information and technical aspects for the complete laboratory process from detection of the clonal IG gene rearrangements and the chromosomal translocations at diagnosis to the actual MRD measurements in clinical follow-up samples of B-NHL. However, it should be noted that MRD diagnostics for clinical treatment protocols has to be accompanied by regular international quality control rounds to ensure the reproducibility and reliability of the MRD results. This is available by the EuroMRD network ( https://euromrd.org ), a subgroup of ESHLO ( https://eslho.org ).

Digitalization's influence on corporate sustainability strategies in the context of new environmental law

Following the implementation of the new environmental law, this paper investigates the impact of digitalization on corporate sustainability, grounded in digital economy strategies and sustainable development principles. Utilizing a sample of Chinese A-share listed companies from 2015 to 2021, the study explores how corporate digitalization influences their sustainable development and the underlying mechanisms involved. The findings indicate that corporate digitalization significantly improves sustainable development, with internal control quality and financing constraints acting as partial mediators in this process. Based on these findings, recommendations are provided to help Chinese listed companies implement the sustainable development strategies.

Validation, implementation and quality control of a Torque Teno Virus qPCR in a multinational clinical trial

BackgroundImmunosuppressive medication after organ transplantation is usually dosed through therapeutic drug monitoring. Trough levels of antirejection medication however, do not adequately predict rejection or infections. The TTVguideIT trial is a multinational clinical trial evaluating the safety of Torque Teno Virus (TTV) load assessed by qPCR, as an alternative to trough level tacrolimus dosing. MethodsPrior to, and during the clinical trial, the inter-and intra-laboratory variability, accuracy, and precision of the TTV R-GENE® assay was evaluated through analysis of internal quality control (IQC), external quality assessment (EQA) and linearity panels performed by the thirteen participating clinical virology laboratories, each using their standard testing platforms. ResultsIQC samples with a target of 4 log10 copies/mL (cp/mL) were tested by the participating laboratories 130 times during the implementation phase and 987 times during the trial phase. They showed excellent accuracy, with an inter-laboratory standard deviation (SD) of 0.17 log10 cp/mL, and an intra-laboratory SD of 0.03 to 0.20 log10 cp/mL during the implementation phase, and an inter-laboratory SD of 0.19 log10 cp/mL, and an intra-laboratory SD 0.07 to 0.18 log10 cp/mL during the trial phase. Three EQA panels and three linearity panels showed similarly small variability during implementation as well as within the trial phase. ConclusionThis data shows that TTV load measurement can be standardized for use in a multinational clinical trial. By using IQC, LP and EQA samples, the quality and integrity of the assay can be compared between laboratories and precise and accurate results can be generated.

Implementasi Kinerja Operasional dan Kepuasan Pelanggan Terhadap Tingkat Penjualan

This study aims to analyze the impact of operational performance implementation and customer satisfaction on sales levels, with a case study on the D'One Acc Cellphone Counter. Operational performance includes internal process efficiency, quality control, and technology use, while customer satisfaction includes product quality, service, and customer experience. This study uses a quantitative method with a survey approach to collect data from customers and employees of the D'One Acc Cellphone Counter. The results of the analysis showed that there was a significant positive relationship between operational performance and customer satisfaction levels. In addition, customer satisfaction has a positive effect on sales levels. Good operational performance improves the quality of products and services, which in turn increases customer satisfaction and drives higher sales. These findings underscore the importance of integrating effective operational strategies and focusing on customer satisfaction to achieve increased sales. This research provides insight for the management of D'One Acc Hp Counters in formulating better strategies to improve operational performance and customer satisfaction, as well as maximize sales potential.

Digital transformation and enterprise external pay gap: Internal mechanism and empirical evidence

Using data from Chinese listed companies from 2010 to 2022 and machine learning methods, we measure enterprise digital transformation (EDT) and investigate its impact on the external pay gap. This study finds that EDT significantly increases the external pay gap of employees and executives. Moreover, EDT's influence on the external pay gap is primarily due to improved intrinsic value and internal control quality. Further research identifies that widening the external pay gap improves innovation input and output.

Empirical research on the effects of mandatory auditing for SMEs on their internal control quality and management’s perceptions: Evidence from Egypt

Empirical research on the effects of mandatory auditing for SMEs on their internal control quality and management’s perceptions: Evidence from Egypt

Internal Quality Control and the Role of Learning Management Systems (LMS) in Higher Education Institutions in Sierra Leone: Then, Now, and Later

The paper explores the evolution of Internal Quality Control (IQC) in Sierra Leone's higher education institutions (HEIs) with a specific focus on the transformative role of Learning Management Systems (LMS). Beginning with the colonial era, the paper traces the historical context of IQC, emphasizing its informal nature. The post-independence expansion of HEIs introduced quality challenges compounded by economic constraints and political instability. The civil war further disrupted the education sector, and the reconstruction period saw the establishment of the Tertiary Education Commission (TEC), formalizing IQC processes. The introduction of LMS platforms, such as Moodle and Google Classroom, marked a pivotal shift in enhancing educational quality. LMS has significantly contributed to data-driven decision-making, standardized educational processes, and continuous feedback mechanisms. However, challenges remain, including infrastructural limitations and the urban-rural digital divide. The paper also projects the future of IQC, highlighting the potential integration of advanced technologies such as artificial intelligence, big data analytics, and blockchain in LMS platforms. These advancements promise to revolutionize the educational experience, offering new possibilities for quality assurance and student engagement.

Cross-ownership and Corporate Innovation

This article takes Chinese A-share listed companies from 2014 to 2022 as the research sample, and uses a multiple regression model to empirically test the relationship between cross-ownership and corporate innovation efficiency. Research has found that: (1) cross-ownership can improve the innovation efficiency of enterprises. (2) when the internal control quality of the enterprise is high and the legal system environment is good, the promoting effect of Cross-ownership on the innovation efficiency of the enterprise is more significant.

A novel method for the preparation of reproducible, stable, and non-infectious quality control materials for Chlamydia trachomatis nucleic acid detection.

Chlamydia trachomatis (CT) is a significant sexually transmitted pathogen known to evoke severe complications, including infertility. Nucleic acid amplification tests (NAATs) are recommended by the World Health Organization to detect CT infection. Furthermore, the establishment of methods, performance validation, internal quality control, and external quality assessment for CT NAATs necessitate the utilization of quality control materials (QCs). QCs are specimens or solutions that are analyzed for quality control purposes in a test system. In this study, we established a novel cell line that stably integrates CT amplification target sequences for producing QCs for CT NAATs. Utilizing clustered regularly interspaced short palindromic repeats/CRISPR-associated protein 9 technology, we integrated the CT plasmid-mediated sequence (comprising the full length of the cryptic plasmid and the major outer membrane protein gene, 9,136 bp) into the MUC4 gene of HEK293T cells. Positive clones were screened through flow cytometric sorting, single-cell culture, and PCR-based identification, followed by the establishment of stable cell lines. These cells were then processed using optimized cell preservation procedures to prepare QCs. The sequence insertion copy number was confirmed by real-time quantitative PCR. This novel CT QCs demonstrate excellent clinical applicability, non-infectiousness, quantifiability, and stability. With an integrated sequence exceeding 9 kb in length, it offers exceptional flexibility for adapting to new kit developments. Furthermore, maintaining a well-defined copy number and stable shelf life, the QCs closely aligns with the quality control requirements of CT NAATs. This study presents an innovative method for preparing QCs for CT nucleic acid detection, making a valuable contribution to improving the performance of CT NAATs.IMPORTANCEUntreated CT infections impose significant burdens on individuals and communities, underscoring the importance of early and accurate testing via CT NAATs for disease control. QCs are instrumental in identifying testing process issues. Hence, we developed a cell line integrating CT-amplified target sequences as readily accessible non-infectious QCs. These QCs boast several advantages: the integration of over 9 kb of CT sequence allows for broad applicability, allowing flexible adaptation to the development of new kits. Confirming the CT sequence copy number provides a reliable basis for QC concentration preparation and kit detection limit evaluation. Optimized preservation protocol enhances QC stability during storage, facilitating convenient shipment to clinical laboratories at ambient temperatures. In summary, our novel CT QCs offer a powerful tool for improving CT NAAT performance and present a fresh perspective on QC preparation for detecting nucleic acids from intracellular parasitic pathogens.

Internal Quality Controls in the Medical Laboratory: A Narrative Review of the Basic Principles of an Appropriate Quality Control Plan

To ensure the quality of their analyses, medical laboratories carry out internal quality control (IQC) on a daily basis. IQC involves control samples with known target values for all parameters used by a laboratory in clinical practice. The use of IQC enables the laboratory to monitor the accuracy and precision of laboratory results. The use of appropriate IQC strategies has been accepted in medical laboratories for decades, and IQC has been included in international recommendations and guidelines. The term “IQC strategy” (also termed a quality control plan) refers to the types of IQC materials to be measured, the frequency of IQC events, the number of concentration levels in each IQC event, and the IQC rules to be used. A scientifically sound IQC strategy must follow two principles, namely, (1) statistical follow-up on the IQC results generated in the laboratory by means of Levey–Jennings control charts and Westgard rules (i.e., quality control by means of statistical procedures) and (2) the determination of limits on the basis of medical considerations and the definition of analytical goals (quality control on the basis of medical relevance). In this narrative review, we describe the fundamental principles of an adequate IQC strategy for laboratorians and nonlaboratorians.

B-109 Six Sigma Analysis for Enhancing Biochemistry Internal Quality Control in a Private Laboratory in India

Abstract Background This abstract outlines a comprehensive study on the application of Six Sigma methodologies to optimize internal quality control processes in a private biochemistry laboratory in India. Data collection was performed using Bio-Rad Assayed Chemistry Control on the Roche cobas 6000 instrument, facilitated by Bio-Rad Unity software. The study adheres to Clinical Laboratory Improvement Amendments (CLIA) 2024 guidelines, specifically focusing on Total Error (TEa). Methods The analytical performances of Cobas c501 insturment as analyse by running biochemical tests (urea, creatinine, uric acid, total bilirubin, AST, Amylase, Lipase, CK, LD, ALT, ALP, LDH, HDL-C, Ca2+, cholesterol, TG, HDL LDL, total protein, albumin, Na+, K+, and Cl−) and glucose on Cobas 400 were evaluated. Biases and CV were obtained from internal quality control programs using biorad unity software. The performance of each instrument was assessed using the σ scale; the benchmark performance was <3 σ (improvement needed); “world-class” quality was six sigma. Results Analytes such as “Alk PO4,” “ALT,” “Amylase,” “Bilirubin,” “CK,” “GGT,” “LD,” “Phosphorus,” “HDL,” “LDL Cholesterol,” “Triglycerides,” and “Uric acid” exhibited impressive sigma scores exceeding 6. Meanwhile, analytes including “Calcium,” “Total Cholesterol,” “Potassium,” “Total Protein,” “Urea,” and “Glucose” achieved sigma scores between 4 and 6, demonstrating noteworthy performance within acceptable bounds. Conclusions This study contributes valuable insights to laboratory management, specifically in the context of biochemistry testing in private Indian laboratories. The adoption of Six Sigma principles, coupled with adherence to CLIA 2024 guidelines and the utilization of advanced instrumentation and software, ensures compliance with regulatory requirements and fosters a culture of continuous improvement. This positions the laboratory to deliver high-quality and reliable results in the dynamic landscape of healthcare diagnostics.

A-131 An External Laboratory Validation of the Atellica IM Serum Neurofilament Light Chain Assay

Abstract Background Neurofilament light chain (NfL) in serum is a promising biomarker for axonal injury with potential for use in neurodegenerative disease testing, including multiple sclerosis (MS), Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS). This study validated the Siemens Healthineers Atellica® IM Serum Neurofilament Light Chain (sNfL) assay* for research applications. Methods Precision studies were performed using serum and plasma samples. Intra-assay precision comprised three levels of internal assay quality control (QC) and one plasma or serum pool (consisting of serum spiked with CSF). For plasma, one aliquot of each sample was tested in duplicate in two runs per day >2 hours apart for up to >20 days. Serum inter-assay involved three levels of internal assay QC run over 10 days (1 run/day). Sensitivity studies were performed to evaluate the limit of quantitation (LoQ) for serum and plasma using five low concentration samples. Each concentration was tested in 25 replicates for serum, and 50 replicates for plasma. Linearity studies involved five levels, each run three times in duplicate (plasma) or four times (serum). Method comparison studies were performed according to CLSI EP09-A3 using the Atellica® IM NfL laboratory developed test (LDT) offered by Siemens Healthcare Laboratory, LLC. 50 samples within the measuring interval of the LDT for each sample type (plasma and serum) were tested. Results Intra-assay coefficients of variation (%CVs) for internal QC ranged from 1.7-2.5% for concentrations spanning 12.75 to 147.22 pg/mL. Serum and plasma pool intra-assay %CV were 2.5% and 3.4%, respectively. Inter-assay precision of serum %CVs ranged from 2.9-16.1% for 13.4 to 150.8 pg/mL. Plasma inter-assay %CVs demonstrated a slightly improved precision versus serum across runs with %CV ranging from 2.4-12.8% with plasma concentrations ranging from 13.4 to 158.0 pg/mL. Serum and plasma LoQs, defined as the concentration at which CV is <20%, were 2.5 pg/mL (serum/plasma). The assay was linear between 2.5 to 300 pg/mL for serum and plasma. The Atellica IM sNfL assay method comparison to the Atellica IM NfL LDT was analyzed using a Passing-Bablok linear regression model. The assays exhibited acceptable agreement with slopes in the range of 1.12-1.14 across the sample interval tested, 6.4 to 460 pg/mL for serum/plasma. Conclusions This external validation of the Atellica IM sNfL assay demonstrated performance characteristics suitable for research applications. *For Research Use Only. Not for use in diagnostic procedures.

A-193 Optimizing Emergency Laboratory Operations Through Six-Sigma Strategies for Enhanced Efficiency and Effectiveness: A Pilot Study

Abstract Background Quality assurance is vital in laboratory diagnostics to ensure patient safety and accurate results. Laboratories employ internal and external quality control measures, particularly focusing on the analytical phase. Sigma metrics, representing process variation, play a crucial role in assessing accuracy, with Six Sigma setting high standards for operational excellence. This study aims to enhance laboratory testing procedures by analyzing the analytical phase. In 2022, the Emergency laboratory at KFAFH, Jeddah, achieved optimal sigma performance, marking a significant improvement in analytical testing. http://www.westgard.com/sigma-vp-kfafh.htm. In 2023, The study also demonstrated a 30% productivity increase, driven by sustained efforts and Sigma metrics implementation, leading to cost reductions and improved quality. Real-time patient moving averages enhance quality assurance, extending coverage to the total testing process. The primary objectives include redesigning IQC procedures and optimizing resource utilization. This will be accomplished by reducing the frequency of controls, minimizing unnecessary reruns, optimizing resource allocation, and managing total costs, all while ensuring compliance and averting violations. Methods A retrospective-prospective study was conducted at the Emergency Laboratory of King Fahad Armed Forces Hospital in Jeddah, Saudi Arabia, from May 2021 to October 2023. The study assessed 841,558 tests for 131,785 emergency patients. Forty-seven analytes were evaluated for Internal Quality Control and External Quality Control (CAP), with monthly data collection. Chemistry and Hematology parameters were analyzed using Unity Real-Time software on Alinity-ci and Alinity-hq analyzers. Data was collected in three stages: baseline, pre-Sigma verification, post-Sigma implementation, and a sustainability phase. The methodology involved DMAIC model tools like flowcharts, cause & effect analysis, and sigma metric scales. Six Sigma process tools, including DPM and process capability analysis, were used. Interventions included Six Sigma metrics for QC performance, DPM for TAT process improvement, and patient moving average Real-time for proactive risk management in reducing analytical testing variation. Results Excellent performance (> 6 sigma) was achieved for 70% of chemistry test parameters for three control levels.: This indicates a high level of process capability and reliability in laboratory operations, ensuring accuracy and consistency in test results. The study successfully reduced process variation in Emergency Room (ER) laboratory Turnaround times (TATs), leading to an increase in process capability as measured on the Sigma scale, which improved from 1.35 to 3.1, indicating a more robust and efficient laboratory operation. Reducing the cost and efficiency of internal failure controls by 29% and at the same time saving in labor cost/workload marked a decrease in QC frequency from 7.0% to 0.18%, reaching the target goal of TATs and satisfaction. Conclusions The adoption of Six Sigma methodologies resulted in a notable decrease in QC runs, signaling cost savings. These high-quality methods streamline laboratory operations, improve cost-effectiveness for the healthcare system, and ultimately benefit patients and clinicians. Six Sigma methodologies play a crucial role in selecting appropriate QC designs for each parameter, ensuring efficient control while maximizing cost-effectiveness. Emphasizing the importance of suitable QC strategies and continuous technologist training is vital for mitigating analytical errors and enhancing turnaround time through comprehensive automation of the analytical phase.

B-128 Delivering Predictable Operational efficiency gains at our core central reference laboratory with strategic deployment of navify® Lab Operation informatics automation solution

Abstract Background Metropolis Healthcare Limited (‘MHL’) operates a network of 200 clinical labs in India, our Global Reference Lab (GRL) in Mumbai processes over 25000 tests in a 17 hour daily operation. We are an ISO15189 and CAP accredited laboratory. Our strategic goals have been to bring operational standardization across the network & Improve speed of service with a predictable 90 percentile production TAT. To achieve this goal, we chose digitalization of our laboratory operation with the deployment of navify ® Lab Operations informatics automation solution in. This poster explains our journey of planning, implementing, and delivering on our goal of predictable operational efficiency. The digital solution is at the forefront of all digitalization IQC processes, auto validation and auto approval of patient results passing through a framework of autoverification rules and complete traceability of processes. Methods The poster will explain the scope, planning and implementation approach of this digital automation project at Global reference Lab in 5 stepsHL7 order structure for communication between LIS and navify ® Lab Operations22 analyzers from 11 different manufacturers being connected to the Informatics solution. the corresponding testingTest & IQC (Internal Quality Control) Master with specific ranges and rules10 steps AV (Auto verification) Rules decision framework of concentric sieves across lab disciplines (155 AV Algorithms have been configured at GRL)Structured user acceptance testing framework before Go Live. Results This poster discusses the outcomes that we have seen on deployment of this digital solution.Over 25,000 test results are subject AV engine daily with AV rate of 75 % of all results in Biochemistry, Immunoassays.66 % of all Complete Blood Count (CBC) reports 95 % of all HbA1c results 93 % of all ESR resultsOver 1750 QC results are subject to QC rules dailyThere is an improvement of 4 hours observed in production TAT Conclusions Laboratory Informatics solution has enhanced lab performance in terms of TAT & efficiency of review. The staff satisfaction (both technical and medical) has increased and we see an impact on production outcome. The poster will also show an incremental effectiveness analysis by comparing key performance areas such as predictability in production, staff time saved, before and after technology deployment.

A-045 Analytical and Clinical Evaluation of A1c Test by HPLC - Lifotronic™ H100Plus Analyzer - in a Brazilian Clinical Laboratory

Abstract Background Over the years, the measurement of Glycated Hemoglobin (A1c) has solidified as an important risk marker for pre-diabetic patients and for the diagnosis and control of diabetic patients. The High-Performance Liquid Chromatography (CLAE) method has been adopted in prospective studies such as the DDCT, and international certification by the NGSP is available. In this study, analytical performance metrics including imprecision, correlation, linearity, carryover, and detection of hemoglobin variants were evaluated for the Lifotronic® H100 Plus analyzer from China. Methods The results were evaluated following CLSI guidelines on samples within stability, collected according to standardized procedures. For the comparative method, 40 patient samples ranging from 4 to 15.4% were analyzed, and two concentrations of internal quality control material were used for intra-assay (5 repetitions per day) and inter-assay (over five days) imprecision testing. Linearity was assessed using samples at two concentrations, one low (4.5%) and another high (17.2%). For carryover evaluation, low (4.98%), intermediate (9.97%), and high (14.96%) concentrations were assayed in an interleaved manner. Hemoglobin variants found in the studied population were determined using the same method employed in correlation tests (HbS, HbF, HbC, HbE, and HbD). Results The method comparison study revealed a Total Error for decision levels of 5.6%: 2.23% and 6.5%: 1.70%, which were lower than the maximum allowable Total Error of 3.3% (EFLM - EuBIVAS). The difference plot showed that 95% of the results fell within acceptable limits. Positive bias was observed in 7 out of 40 tested samples, predominantly in samples with concentrations above 6,5%, although the medical team assessed it as having no clinical impact. For intra-assay imprecision, the obtained result was 0.86%, and for inter-assay imprecision, it was 0.87%, both deemed acceptable according to the 3.0 % specification proposed by the supplier for the two tested levels.Linearity tests were approved for concentrations proposed by the manufacturer between 3 and 18%, and no carryover was found between samples. All hemoglobin variants previously detected in the comparative method were also identified in the test method without exception, although the specific type of Hb variant was not identified. Conclusions The Lifotronic™ H100Plus analyzer demonstrated approved analytical performance with some notable observations: positive bias was observed in samples with concentrations above 6,5%, though it was not considered clinically relevant, the throughput of 58 tests per hour could be a limitation for laboratories with high testing volumes and the analyzer detected the presence of Hb variants, although it did not identify their specific types.

A-189 Six Sigma for Thyroid Stimulating Hormone (TSH)

Abstract Background Effective quality control processes within clinical laboratories are crucial for monitoring and assessing the analytical performance in terms of precision and accuracy. The regular measurement of these parameters plays a pivotal role in ensuring patient safety and is often a prerequisite for accreditation by various organizations. Six Sigma metrics have emerged as one of the most efficient tools for evaluating the analytical performance of clinical laboratory systems. This approach integrates Total Allowable Error (TEa), encompassing both random and systematic errors into a single comprehensive index. This study details the establishment of Six Sigma in our laboratory for Thyroid Stimulating Hormone (TSH) for eight different modules of Siemens Atellica IM. Methods A one-year dataset was compiled from the assessment of internal quality control for evaluating the imprecision (expressed as coefficient of variation - CV%) and Bio Rad’s Unity Interlaboratory Program for inaccuracy (quantified as bias%) in TSH test processed across eight modules of Atellica IM (Siemens). The data was categorized into two groups based on QC levels. The TEa utilized in this study was set at 20% according to CLIA standards. Six Sigma metrics were subsequently calculated for each QC level and equipment based on TEa, CV%, and bias%, utilizing the formula Sigma=(TEa - bias%)/CV%. Results Six Sigma values calculated for the QC level 1 ranged from 4.92 to 6.20 across all equipment, while for the QC level 2 Six Sigma varied from 4.87 to 7.59. All values found were classified as Good, Excellent and World Class according to the normalized method decision chart. These results showed that analytical performance of all eight modules of Atellica IM were similar in terms of random and systematic error. Conclusions Six Sigma serves as potent tool for monitoring the analytical performance of the TSH test. It is crucial to independently track different levels of QC in TSH testing for enhanced control over the analytical system. The performance of Siemens TSH test in our laboratory has proven to be very satisfactory.