Internal Quality Control Research Articles

Internal quality control in a clinical biochemistry laboratory: Management of non-conformities on the general chemistry automate DXC800

Internal quality control in a clinical biochemistry laboratory: Management of non-conformities on the general chemistry automate DXC800

Internal quality control in a clinical biochemistry laboratory: Management of non-conformities on the general chemistry automate DxC800

Internal quality control in a clinical biochemistry laboratory: Management of non-conformities on the general chemistry automate DxC800

Information infrastructure and corporate green innovation quality incentive

We use a sample of Chinese firms from 2006 to 2020 to investigate the effect of information infrastructure on the quality of green innovation. Findings show that information infrastructure significantly improves corporate green innovation quality, and information infrastructure improves the pricing efficiency, improves valuation levels, accelerates the flow of innovation resources, and induces the growth effect of corporate innovation resources. Furthermore, we find that executive salary incentives, internal control quality, and market-oriented environmental regulation have adaptive incentives for information infrastructure to improve the quality of green innovation. Our findings provide justification to promote the construction of an information infrastructure and adopt market-oriented environmental regulations to improve corporate green innovation quality.

Management of internal quality control in haemostasias at Hematology Laboratory Farhat Hached Hospital, Sousse

Management of internal quality control in haemostasias at Hematology Laboratory Farhat Hached Hospital, Sousse

An evaluation of the internal quality control performance of the general biochemistry analytes in a laboratory of a tertiary care hospital of Sri Lanka

An evaluation of the internal quality control performance of the general biochemistry analytes in a laboratory of a tertiary care hospital of Sri Lanka

The Implementation of Traceability and Ensuring Validity of Results at Testing Laboratories for Air and Exhaust Gas in Indonesia

Ensuring metrological traceability and result validity is a critical aspect of testing laboratories to obtain reliable results and ensure comparability. A survey was conducted in testing laboratories to assess the extent of traceability and result validity assurance through the utilization of certified reference materials and the implementation of quality assurance. The objective of this survey is to determine the necessary types of reference materials and proficiency tests, particularly for air and exhaust gas laboratories, in order to enhance the development of reference materials and proficiency testing services. The survey involved distributing a questionnaire regarding the utilization of certified reference materials and the implementation of quality assurance to accredited air and exhaust gas testing laboratories. The findings revealed that out of the 25 participating laboratories, a significant portion had not yet incorporated the use of certified reference materials in their testing processes. Although internal quality control measures were generally implemented across laboratories, only 40% had adopted external quality control methods, such as comparative and proficiency tests. Consequently, it is evident that there is an urgent need to develop reference materials for all parameters of air and exhaust gas testing, and there is a requirement for updated information for proficiency test providers.

Arranging internal financial control in public institutions: Obstacles and strategies to mitigate them

Subject. This article discusses the issues of arranging effective internal financial control in government institutions of the Russian Federation. Objectives. The article aims to identify the key problems of arranging internal control in government institutions and develop recommendations for its improvement. Methods. For the study, I used the methods of comprehensive and statistical analyses, and comparison. Results. The article finds that preliminary control has significant advantages in preventing budget violations. An analysis of the performance indicators of institutions demonstrates the availability of reserves for improving the quality of internal control. Conclusions. Based on the results of a comprehensive study, the article concludes that it is necessary to solve a number of problems in the field of personnel, technological and methodological support for arranging an effective system of internal financial control in public institutions. The implementation of the proposed measures will contribute to improving the effectiveness of the use of budget funds.

Quality control in the Netherlands; todays practices and starting points for guidance and future research.

Adequate analytical quality of reported results is primarily ensured by performing internal quality control (iQC). Currently, several different iQC practices are in use. As a prelude to the revision of a Dutch guidance document on analytical QC, a questionnaire was sent out to gain insights in the applied practices and the need for guidance. A questionnaire, containing 20 multiple-choice questions with possibilities for explanation and comment on iQC practices and aspects was distributed to all clinical chemistry laboratories within the Netherlands. Results were reported descriptively. Responses were received from 27 clinical laboratories (response 43 %). In 30 % the iQC was based on the analytical characteristics only, while 30 % used a 6-Sigma method, 19 % risk-based beyond 6-Sigma and 22 % used an alternative approach. 89 % of laboratories used a virtual analyzer model for iQC setup within one or more laboratory sites. Practices for determining standard deviation (SD) values included determining SD for each new iQC material (35 %), using historical SD values for new materials (35 %), and incorporating clinical tolerances into the SD value (31 %). Furthermore, 44 % of laboratories used patient moving averages for one or more tests. Daily iQC management was based on either "traffic lights" indicating in or out of control status, and review of all QC charts, often using multiple software systems. A large heterogeneity of iQC practices in clinical laboratories was observed in the Netherlands. Several starting points for further research and/or guidance were identified, particularly in relation to the determination of SD values, the virtual analyzer model and methods to ensure analyzer equivalence.

Using analytical performance specifications in a medical laboratory.

Analytical performance specifications (APS) are used for the quantitative assessment of assay analytical performance, with the aim of providing information appropriate for clinical care of patients. One of the major locations where APS are used is in the routine clinical laboratory. These may be used to assess and monitor assays in a range of settings including method selection, method verification or validation, external quality assurance, internal quality control and assessment of measurement uncertainty. The aspects of assays that may be assessed include imprecision, bias, selectivity, sample type, analyte stability and interferences. This paper reviews the practical use of APS in a routine clinical laboratory, using the laboratory I supervise as an example.

Comparison of the sigma metrics using the total error allowable algorithm with variation of bias source

Sigma Metrics, as a quality indicator, have been widely applied in clinical laboratories to assess the performance of analytical methods. Described in the document Clinical and Laboratory Standards Institute (CLSI) EP15- A3, the use of target values can be sourced from certified reference standards, survey materials from the Proficiency Testing (PT)/External Quality Assessment (EQA), materials used in inter-laboratory quality control programs and internal quality control materials with predetermined targets. This research aims to determine whether there is a difference in the sigma metrics between the bias derived from the manufacturer's target value and those from the peer group source in the External Quality Assurance Services (EQAS) program. The research methodology employed is descriptive comparative analysis, utilizing the results of material inspection data for 15 internal quality control parameters of Clinical Chemistry over a span of 2 years at the Pramita Laboratory in Bandung. The calculation of the sigma metrics commences with computing the coefficient of variation (CV), and the appropriate Total Error aalowable (Tea) sources for each parameter are determined beforehand using the TEa algorithm. The research findings indicate a difference between the sigma metrics derived from the manufacturer's target value and those from the EQAS-peer group target value, accounting for 33% or 10 parameters out of the total parameters with 2 levels of inspection are calculated on the sigma scale. However, in 67% or 20 parameters out of the total parameters, no such difference is observed. Bias associated with the target value from the manufacturer and the EQAS peer group shows no significant difference, suggesting that the laboratory can utilize pre-existing target values confidently.

Measuring the Quality of Internal Control and its Impact on the Performance of the Banking Institutions

The researcher aimed to assess the impact on the institutional performance of the bank’s sample research, the statement of relationship, and the quality of internal control through his research. There were seven banks in the government commercial bank research community, and two banks were included in the sample research. To evaluate his research hypotheses, the investigator used a two-axis resolution distributed among 45 questions, totaling 68. A basic linear regression model was employed by the researcher. According to Pearson's coefficient of correlation with the research findings, the study sample banks demonstrated both high levels of institutional performance and internal control quality. Additionally, it demonstrated a statistically significant relationship between the quality of internal control and the banking institution's performance. Based on these findings, the researcher recommended that banks take a greater interest in internal control, which will help to improve the institutions' overall performance.

Does enterprise digital transformation affect audit opinion type?—Based on business evidence of Chinese listed companies

AbstractUtilizing text analysis through machine learning techniques, this study investigates the influence of enterprise digital transformation on audit opinions within China's A‐share listed companies spanning from 2011 to 2020. The findings underscore that enterprise digital transformation has the potential to bolster standard unqualified audit opinions through the enhancement of internal control quality and information transparency. Additionally, factors such as marketization level, property rights nature, and industry classification are found to be pivotal in shaping this relationship. These research outcomes not only extend the theoretical horizons of audit opinion studies but also offer valuable insights and recommendations for auditors to optimize the efficacy of audit opinions.

Are ESG scores affected by the quality of non-financial disclosures?

ESG scores are an important indicator of a company's performance in the areas of environmental, social responsibility and corporate governance, and non-financial information as the basis for a company's ESG score has received increasing attention in recent years. Based on the data of A-share listed companies in Shanghai and Shenzhen from 2007 to 2022, the study finds that disclosing non-financial information that is more similar to that of other companies in the same industry reduces a company's ESG score, while the higher the readability and forward-looking content of the disclosure, the higher the ESG score. Mechanism tests suggest that the act of digital transformation causes firms to disclose non-financial information that affects ESG scores. Other analyses show that higher similarity of non-financial information in non-high-tech firms has a greater impact on ESG scores, while firms with different firm sizes and internal control quality respond differently to ESG scores. This study reveals the characteristics of non-financial information disclosure in detail, enriches the related research on the influencing factors of ESG scores, provides theoretical support and practical value for the principles and directions of non-financial information disclosure of listed companies, and provides ideas and directions for the vigorous development and improvement of ESG scores.

The role of analytical performance specifications in international guidelines and standards dealing with metrological traceability in laboratory medicine.

The goal of metrological traceability is to have equivalent results for a measurand in clinical samples (CSs) irrespective of the in-vitro diagnostic medical device (IVD-MD) used for measurements. The International Standards Organization standard 17511 defines requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples used with IVD-MDs. Each step in metrological traceability has an uncertainty associated with the value assigned to a material. The uncertainty at each step adds to the uncertainty from preceding steps such that the combined uncertainty gets larger at each step. The combined uncertainty fora CS result must fulfil an analytical performance specification (APS) for the maximum allowable uncertainty (umax CS). The umax CS can be partitioned among the steps in a metrological traceability calibration hierarachy to derive the APS for maximum allowable uncertainty at each step. Similarly, the criterion for maximum acceptable noncommutability bias can be derived from the umax CS. One of the challenges in determining if umax CS is fulfilled is determining the repeatability uncertainty (u Rw) from operating an IVD-MD within a clinical laboratory. Most of the current recommendations for estimating u Rw from internal quality control data do not use a sufficiently representative time interval to capture all relevant sources of variability in measurement results. Consequently, underestimation of u Rw is common and may compromise assessment of how well current IVD-MDs and their supporting calibration hierarchies meet the needs of clinical care providers.

Ten-year results of an international external quality control programme for measurement of anti-tuberculosis drug concentrations.

Participation in an external (interlaboratory) quality control (QC) programme is an essential part of quality assurance as it provides laboratories with valuable insights into their analytical performance. We describe the 10 year results of an international QC programme for the measurement of anti-tuberculosis (TB) drugs. Each year, two rounds were organized in which serum (or plasma) samples, spiked with known concentrations of anti-TB drugs, were provided to participating laboratories for analysis. Reported measurements within 80%-120% of weighed-in concentrations were considered accurate. Mixed model linear regression was performed to assess the effect of the measured drug, concentration level, analytical technique and performing laboratory on the absolute inaccuracy. By 2022, 31 laboratories had participated in the QC programme and 13 anti-TB drugs and metabolites were included. In total 1407 measurements were reported. First-line TB drugs (isoniazid, rifampicin, pyrazinamide and ethambutol) represented 58% of all measurements. Overall, 83.2% of 1407 measurements were accurate, and the median absolute inaccuracy was 7.3% (IQR, 3.3%-15.1%). The absolute inaccuracy was related to the measured anti-TB drug and to the performing laboratory, but not to the concentration level or to the analytical technique used. The median absolute inaccuracies of rifampicin and isoniazid were relatively high (10.2% and 10.9%, respectively). The 10 year results of this external QC programme illustrate the need for continuous external QC for the measurement of anti-TB drugs for research and patient care purposes, because one in six measurements was inaccurate. Participation in the programme alerts laboratories to previously undetected analytical problems.

Effect of internal audit, internal control, and audit quality on fraud prevention: Evidence from the public sector in Indonesia

Fraud prevention entails developing and implementing risk management strategies, particularly regarding fraud, and establishing internal controls and transparent corporate governance practices to eliminate fraudulent activities. This study aims to examine the effect of internal auditors, internal control, and audit quality on preventing fraud at the Inspectorate of North Sumatra Province, Indonesia. The sample included 61 government internal auditors of the Inspectorate of North Sumatra Province, Indonesia. The data collection process was carried out by administering questionnaires using Google Forms. Additionally, this investigation assessed the constructs under scrutiny using a five-point Likert and the partial least square (PLS) approach. The results showed that internal audit has a positive and significant effect on fraud prevention (p < 0.05), internal control has a positive and significant effect on fraud prevention (p < 0.05), and audit quality has no effect on fraud prevention at the Inspectorate of North Sumatra Province, Indonesia (p > 0.05). The Inspectorate of North Sumatra Province, Indonesia, should conduct internal audits, implement an internal control system, and pay attention to the quality of audits to make them more effective as a basis for quality decision-making and fraud minimization.

More Efficient Manual Review of Automatically Transcribed Tabular Data

Any machine learning method for transcribing historical text requires manual verification and correction, which is often time-consuming and expensive. Our aim is to make it more efficient. Previously, we developed a machine learning model to transcribe 2.3 million handwritten occupation codes from the Norwegian 1950 census. Here, we manually review the 90,000 codes (3%) for which our model had the lowest confidence scores. We allocated these codes to human reviewers, who used our custom annotation tool to review them. The reviewers agreed with the model's labels 31.9% of the time. They corrected 62.8% of the labels, and 5.1% of the images were uncertain or assigned invalid labels. 9,000 images were reviewed by multiple reviewers, resulting in an agreement of 86.4% and a disagreement of 9%. The results suggest that one reviewer per image is sufficient. We recommend that reviewers indicate any uncertainty about the label they assign to an image by adding a flag to their label. Our interviews show that the reviewers performed internal quality control and found our custom tool to be useful and easy to operate. We provide guidelines for efficient and accurate transcription of historical text by combining machine learning and manual review. We have open-sourced our custom annotation tool and made the reviewed images open access.

Influence of ultrafiltration conditions on the measurement of unbound drug concentrations: flucloxacillin as an example.

When performing therapeutic drug monitoring (TDM) for flucloxacillin, it is advised to measure the unbound, not the total, flucloxacillin concentration. To be able to accurately quantify unbound flucloxacillin concentrations, a reliable analytical method is indispensable. To determine the influence of temperature and pH of the sample during ultrafiltration on the measured unbound fraction of flucloxacillin. We performed three different experiments. In a single laboratory experiment, we investigated the influence of ultrafiltration temperature (10°C, room temperature and 37°C) on the measured unbound fraction of flucloxacillin for three concentration levels. In a multiple laboratory experiment, the results of eight laboratories participating in an international quality control programme measuring unbound flucloxacillin concentrations were analysed. In the third experiment, patient samples were ultrafiltrated using four different conditions: (i) physiological pH and room temperature; (ii) unadjusted pH (pH 9 after freezing) and room temperature; (iii) physiological pH and 37°C and (iv) unadjusted pH and 37°C. For all experiments, measurement of samples that were ultrafiltrated at room temperature resulted in a substantially lower unbound fraction compared to samples that were ultrafiltrated at 37°C. Adjusting the pH to physiological pH only had a minimal impact on the measured unbound fraction. On the basis of these findings and considering the need for fast, simple and reproducible sample pretreatment for TDM purposes, we conclude that ultrafiltration of flucloxacillin should be performed at physiological temperature (37°C), but adjustment of pH does not seem to be necessary.

Analysis of hematology quality control using six sigma metrics.

Clinical laboratories serve a critical role in increasing the efficiency of patient care. Choosing the right test, getting trustworthy results and appropriate interpretation are of utmost importance in improving the patient's well-being. Quality management strategies should be applied in routine patient care because laboratory errors have a major impact on the quality of patient care. In sigma metrics, errors identified are quantified as percentage errors or defects per million (DPM). It aims at improving the quality control (QC) process by forming an appropriate strategy. To analyze the internal quality control (IQC) of hematology analytes using the sigma metrics method and to devise the frequency of IQC by the results of six sigma metric analysis. This study was conducted in a tertiary care center of western India. Internal quality control (IQC) data sets of five analytes- Red Blood Cell count (RBC), Hemoglobin (Hb), Hematocrit (Hct), White blood cell count (WBC), and Platelet count (PLT) were analyzed retrospectively of six months using Beckman Coulter DXH 800 hematology analyzers. The observed sigma value was >6 for Hb, TLC, and PLT, indicating excellent results and requiring no modification in IQC. The Sigma value was between 3 and 4 for RBC and Hct suggested the need for improvement in quality control (QC) processes. No analytes showed a Sigma value of <3. Sigma metrics provide a quantitative framework that helps to assess analytic methodologies and can serve as an important self-assessment tool for quality assurance in the clinical laboratory.

The Polymorphism Analysis of HLA Class II Alleles Based on Next-Generation Sequencing and Prevention Strategy for Allele Dropout

To investigate the accuracy of next-generation sequencing technology (NGS) in detecting the polymorphisms of HLA-DRB1, DQB1, DQA1, DRB3, DRB4, DRB5, DPA1 and DPB1 alleles in randomly-selected unrelated healthy individuals from Shenzhen Han population, investigate the potential reason for HLA-DRB1 allele dropout in routine NGS, and establish an internal quality control system. NGS-based HLA class II genotyping was performed on 1 012 samples using the MiSeqDxTM platform. The suspected missed alleles indicated by the quality control software and HLA-DRB1 homozygotes were confirmed by PCR-SSOP or PCR-SBT methods. A total of 139 alleles were detected, including HLA-DRB1(45), DRB3(7), DRB4(5), DRB5(7), DQA1(17), DQB1(21), DPA1(10) and DPB1(27). HLA-DRB1*09:01(17.09%),15:01(10.72%); DRB3*02:02(25.99%),03:01(10.18%); DRB4*01:03(36.46%); DRB5*01:01(15.42%); DQA1*01:02(20.01%),03:02(17.19%); DQB1*03:01(19.47%),03:03(17.98%), 05:02(11.66%), 06:01(10.67%); DPA1*02:02(54.45%), 01:03(31.18%) and DPB1*05:01(39.13%), 02:01(16.90%) alleles were the most common alleles in Shenzhen Han population (frequencies >10%). There was no statistical difference between the gene frequencies of HLA-DRB1 and DQB1 loci in our study. The HLA Common and Well-Documented Alleles in China (CWD2.4) (χ2=12.68, P >0.05). 94 cases of HLA-DRB1 homozygous samples detected by NGS were retested by PCR-SSOP or SBT method, and one case of allele dropout at HLA-DRB1 locus was found. SBT method confirmed that the allele of DRB1*04:03 was missed. The laboratory internal quality control system was established. Two cases of new alleles were detected and named by WHO Nomenclature Committee for Factors of the HLA System. The HLA genotyping results based on NGS showed a significantly lower ambiguity rate. The HLA class II alleles exhibit genetic polymorphism in the Han population of unrelated healthy individuals in Shenzhen. The independent method based on NGS in clinical histocompatibility testing has limitations and requires internal quality control strategies to avoid allele-dropout events.