Six Sigma performance of quality indicators in total testing process of point-of-care glucose measurement: A two-year review.
Ontology highlight
ABSTRACT: Objectives
The error rate in the total testing process (TTP) of point-of-care (POC) glucose measurement remains high although a total quality management system has been applied. Quality indicators (QIs) in the TTP of glucose meter were established via risk assessment. Their two-year Six Sigma values were reviewed for quality improvement.Design
The TTP of POC glucose measurement was mapped to identify risks in key steps. The risks were assessed for their frequency and severity of impact on patient safety. Whenever possible, measurable data from the data management system and other sources was collected to establish QIs for risk monitoring. Average Six Sigma value of each QI in the last two years was calculated for acceptance and for determining corrective action.Results
29 risks were identified in eight key steps of the TTP. Eight QIs were established for monitoring six risks and three QIs for two accepted risks were established for improving operator testing skill. The QIs had a good coverage to key steps. Two, five and four QIs showed Six Sigma values <3, 3-4 and >4 respectively. Six Sigma values of two QIs related to quality control (QC) testing were improved by using meters with accurate QC sample loading.Conclusions
The establishment of QIs for glucose measurement by risk assessment with measurable data from the data management system and on Six sigma scale was effective, efficient, and manageable. Most of QIs' Six Sigma values were between 3 and 5, which could be improved by using upgraded meters.
SUBMITTER: Vincent A
PROVIDER: S-EPMC8042413 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Six Sigma involves a structured process improvement strategy that places processes on a pathway to continued improvement. The data presented here summarizes a project that took three clinical laboratories from autoverification processes that allowed between about 40% to 60% of tests being auto-verified to more than 90% of tests and samples auto-verified. The project schedule, metrics and targets, a description of the previous system and detailed information on the changes made to achieve greater than 90% auto-verification is presented for this Six Sigma DMAIC (Design, Measure, Analyze, Improve, Control) process improvement project.
| S-EPMC5998219 | biostudies-literature
Project description:ObjectivesPoint of Care Testing (POCT) is a rapidly expanding area of clinical laboratory testing and quality assurance is an important area of focus. Quality indicators (QIs) are a quality management system tool that monitors aspects of the testing process to help meet the challenges associated with maintaining high quality patient safety given the growth in POCT. Alberta aims to formalize the development and use of QIs for POCT.Designand Methods: Potential QIs were identified by reviewing both the current standards and guidelines for QIs in POCT, and the research regarding quality and sources of error in POCT. Quality practices and potential sources of error in POCT were identified by: 1) a Canadian national survey on POCT, and 2) direct observation in two local POCT programs.ResultsA proposed selection of QIs in POCT were identified by incorporating the results from these investigations, while considering the unique characteristics of POCT. These QIs monitor the preanalytical, analytical, and post-analytical phases of testing, and support processes.ConclusionsAs POCT volumes and test menu expands, QIs will be a vital tool in monitoring error and maintaining high quality of results. Adoption of formal QIs will support continuous quality improvement and improved patient care.
| S-EPMC8042172 | biostudies-literature
Project description:BackgroundThe diversity and complexity of invertebrate communities usually result in their exclusion from conservation activities. Here we provide a step process for assessing predominantly ground-dwelling Afrotemperate forest invertebrates' (earthworms, centipedes, millipedes, ants, molluscs) potential as surrogates for conservation and indicators for monitoring. We also evaluated sampling methods (soil and litter samples, pitfall traps, active searching quadrats and tree beating) and temporal (seasonal) effects.Methodology/principal findingsLack of congruence of species richness across taxa indicated poor surrogacy potential for any of the focus taxa. Based on abundance and richness, seasonal stability, and ease of sampling, molluscs were the most appropriate taxon for use in monitoring of disturbance impacts. Mollusc richness was highest in March (Antipodal late summer wet season). The most effective and efficient methods were active searching quadrats and searching litter samples. We tested the effectiveness of molluscs as indicators for monitoring by contrasting species richness and community structure in burned relative to unburned forests. Both species richness and community structure changed significantly with burning. Some mollusc species (e.g. Macroptychia africana) showed marked negative responses to burning, and these species have potential for use as indicators.Conclusions/significanceDespite habitat type (i.e., Afrotemperate forest) being constant, species richness and community structure varied across forest patches. Therefore, in conservation planning, setting targets for coarse filter features (e.g., habitat type) requires fine filter features (e.g., localities for individual species). This is especially true for limited mobility taxa such as those studied here. Molluscs have high potential for indicators for monitoring, and this requires broader study.
| S-EPMC2817749 | biostudies-literature
Project description:Quality is a key determinant in deploying new processes, products, or services and influences the adoption of emerging manufacturing technologies. The advent of additive manufacturing (AM) as a manufacturing process has the potential to revolutionize a host of enterprise-related functions from production to the supply chain. The unprecedented level of design flexibility and expanded functionality offered by AM, coupled with greatly reduced lead times, can potentially pave the way for mass customization. However, widespread application of AM is currently hampered by technical challenges in process repeatability and quality management. The breakthrough effect of six sigma (6S) has been demonstrated in traditional manufacturing industries (e.g., semiconductor and automotive industries) in the context of quality planning, control, and improvement through the intensive use of data, statistics, and optimization. 6S entails a data-driven DMAIC methodology of five steps-define, measure, analyze, improve, and control. Notwithstanding the sustained successes of the 6S knowledge body in a variety of established industries ranging from manufacturing, healthcare, logistics, and beyond, there is a dearth of concentrated application of 6S quality management approaches in the context of AM. In this article, we propose to design, develop, and implement the new DMAIC methodology for the 6S quality management of AM. First, we define the specific quality challenges arising from AM layerwise fabrication and mass customization (even one-of-a-kind production). Second, we present a review of AM metrology and sensing techniques, from materials through design, process, and environment, to postbuild inspection. Third, we contextualize a framework for realizing the full potential of data from AM systems and emphasize the need for analytical methods and tools. We propose and delineate the utility of new data-driven analytical methods, including deep learning, machine learning, and network science, to characterize and model the interrelationships between engineering design, machine setting, process variability, and final build quality. Fourth, we present the methodologies of ontology analytics, design of experiments (DOE), and simulation analysis for AM system improvements. In closing, new process control approaches are discussed to optimize the action plans, once an anomaly is detected, with specific consideration of lead time and energy consumption. We posit that this work will catalyze more in-depth investigations and multidisciplinary research efforts to accelerate the application of 6S quality management in AM.
| S-EPMC8269016 | biostudies-literature
Project description:BACKGROUND: Recent focus on resident work hours has challenged residency programs to modify their curricula to meet established duty hour restrictions and fulfill their mission to develop the next generation of clinicians. Simultaneously, health care systems strive to deliver efficient, high-quality care to patients and families. The primary goal of this observational study was to use a data-driven approach to eliminate examples of waste and variation identified in resident rounding using Lean Six Sigma methodology. A secondary goal was to improve the efficiency of the rounding process, as measured by the reduction in nonvalue-added time. METHODS: We used the "DMAIC" methodology: define, measure, analyze, improve, and control. Pediatric and family medicine residents rotating on the pediatric hospitalist team participated in the observation phase. Residents, nurses, hospitalists, and parents of patients completed surveys to gauge their attitudes toward rounds. The Mann-Whitney test was used to test for differences in the median times measured during the preimprovement and postimprovement phases, and the Student t test was used for comparison of survey data. RESULTS AND DISCUSSION: Collaborative, family-centered rounding with elimination of the "prerounding" process, as well as standard work instructions and pacing the process to meet customer demand (takt time), were implemented. Nonvalue-added time per patient was reduced by 64% (P = .005). Survey data suggested that team members preferred the collaborative, family-centered approach to the traditional model of rounding. CONCLUSIONS: Lean Six Sigma provides tools, a philosophy, and a structured, data-driven approach to address a problem. In our case this facilitated an effort to adhere to duty hour restrictions while promoting education and quality care. Such approaches will become increasingly useful as health care delivery and education continue to transform.
| S-EPMC3184924 | biostudies-other
Project description:BACKGROUND:Accurate serum total thyroxine (TT4) measurement is important for thyroid disorder diagnosis and management. We compared the performance of six automated immunoassays with that of isotope-diluted liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) as the reference method. We also evaluated the correlation of thyroid stimulating hormone (TSH) with TT4 measured by ID-LC-MS/MS and immunoassays. METHODS:Serum was collected from 156 patients between October 2015 and January 2016. TT4 was measured by immunoassays from Abbott (Architect), Siemens (ADVIA Centaur XP), Roche (E601), Beckman-Coulter (Dxi800), Autobio (Autolumo A2000), and Mindray (CL-1000i), and by ID-LC-MS/MS. Results were analyzed using Passing-Bablok regression and Bland-Altman plots. Minimum requirements based on biological variation were as follows: a mean bias of ?4.5% and total imprecision (CV) of ?3.7%. RESULTS:All immunoassays showed a correlation >0.945 with ID-LC-MS/MS; however, the slope of the Passing-Bablok regression line varied from 0.886 (Mindray) to 1.23 (Siemens) and the intercept from -12.8 (Siemens) to 4.61 (Mindray). Only Autobio, Beckman-Coulter, and Roche included the value of one in the 95% confidence interval for slope. The mean bias ranged from -10.8% (Abbott) to 9.0% (Siemens), with the lowest value noted for Roche (3.5%) and the highest for Abbott (-10.8%). Only Abbott and Roche showed within-run and total CV ?3.7%. CONCLUSIONS:Though all immunoassays correlated strongly with ID-LC-MS/MS, most did not meet the minimum clinical requirement. Laboratories and immunoassay manufacturers must be aware of these limitations.
| S-EPMC6400722 | biostudies-literature
Project description:UnlabelledBackgroundThe recent introduction of high throughput sequencing technologies into clinical genetics has made it practical to simultaneously sequence many genes. In contrast, previous technologies limited sequencing based tests to only a handful of genes. While the ability to more accurately diagnose inherited diseases is a great benefit it introduces specific challenges. Interpretation of missense mutations continues to be challenging and the number of variants of uncertain significance continues to grow.ResultsWe leveraged the data available at ARUP Laboratories, a major reference laboratory, for the CFTR gene to explore specific challenges related to variant interpretation, including a focus on understanding ethnic-specific variants and an evaluation of existing databases for clinical interpretation of variants. In this study we analyzed 555 patients representing eight different ethnic groups. We observed 184 different variants, most of which were ethnic group specific. Eighty-five percent of these variants were present in the Cystic Fibrosis Mutation Database, whereas the Human Mutation Database and dbSNP/1000 Genomes had far fewer of the observed variants. Finally, 21 of the variants were novel and we report these variants and their clinical classifications.ConclusionsBased on our analyses of data from six years of CFTR testing at ARUP Laboratories a more comprehensive, clinical grade database is needed for the accurate interpretation of observed variants. Furthermore, there is a particular need for more and better information regarding variants from individuals of non-Caucasian ethnicity.
| S-EPMC3563502 | biostudies-literature
Project description:BackgroundThe aim of this study was to determine the impact of COVID-19 pandemic on the total testing process using six sigma metrics based on a comparison of pre and during pandemic periods.Material & methodsThe study duration was over 12 months, 6 months before and 6 months after the COVID-19 onset in Pakistan in March 2020 after the recognition of the first case, using quality indicators (QIs). QIs were chosen from a model of QIs recommended by the CAP. Analysis was performed using Six Sigma calculators and QIs were expressed in percentage (%) and Sigma value were computed. Three levels of performance quality i.e. 25th, 50th, and 75th percentile were derived, being best, common and worst performance respectively. Between-group differences were tested using the Mann-Whitney's U test.ResultsThe median defect percentages of these QIs ranged from 0% to 0.27% for the pre-pandemic period and 0% to 0.13% for the during pandemic period. Meanwhile, sigma values of the majority of the QIs were all above 4.0σ during the pre and the pandemic times. For the pre-analytical phase, sigma scores declined for 1 QI, improved for 3 QIs and remained same for 2. In the post analytical phase, no change in sigma metrics was noted for critical values notification. Considerable increase in defect percentage of inappropriate turnaround times was noted.ConclusionThe emergency preparedness proved to be fruitful as depicted by exceptional performance on the sigma metrics for most Qis both prior to and during the pandemic. The pre-analytical and the post analytical phases, being the most error sensitive requires strict vigilance.
| S-EPMC8426328 | biostudies-literature
Project description:The subject of the submitted work is the proposal of electrodes for the continual measurement of the glucose concentration for the purpose of specifying further hemodynamic parameters. The proposal includes the design of the electronic measuring system, the construction of the electrodes themselves and the functionality of the entire system, verified experimentally using various electrode materials. The proposed circuit works on the basis of micro-ammeter measuring the size of the flowing electric current and the electrochemical measurement method is used for specifying the glucose concentration. The electrode system is comprised of two electrodes embedded in a silicon tube. The solution consists of the measurement with three types of materials, which are verified by using three solutions with a precisely given concentration of glucose in the form of a mixed solution and enzyme glucose oxidase. For the testing of the proposed circuit and the selection of a suitable material, the testing did not take place on measurements in whole blood. For the construction of the electrodes, the three most frequently used materials for the construction of electrodes used in clinical practice for sensing biopotentials, specifically the materials Ag/AgCl, Cu and Au, were used. The performed experiments showed that the material Ag/AgCl, which had the greatest sensitivity for the measurement even without the enzyme, was the most suitable material for the electrode. This conclusion is supported by the performed statistical analysis. On the basis of the testing, we can come to the conclusion that even if the Ag/AgCl electrode appears to be the most suitable, showing high stability, gold-plated electrodes showed stability throughout the measurement similarly to Ag/AgCl electrodes, but did not achieve the same qualities in sensitivity and readability of the measured results.
| S-EPMC7374362 | biostudies-literature
Project description:BackgroundThe Centers for Disease Control and Prevention (CDC) Guideline for Hand Hygiene in Health Care Settings was issued in 2002. In 2003, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) established complying with the CDC Guideline as a National Patient Safety Goal for 2004. This goal has been maintained through 2006. The CDC's emphasis on the use of alcohol-based hand rubs (ABHRs) rather than soap and water was an opportunity to improve compliance, but the Guideline contained over 40 specific recommendations to implement.ObjectiveTo use the Six Sigma process to examine hand hygiene practices and increase compliance with the CDC hand hygiene recommendations required by JCAHO.DesignSix Sigma Project with pre-post design.ParticipantsPhysicians, nurses, and other staff working in 4 intensive care units at 3 hospitals.MeasurementsObserved compliance with 10 required hand hygiene practices, mass of ABHR used per month per 100 patient-days, and staff attitudes and perceptions regarding hand hygiene reported by questionnaire.ResultsObserved compliance increased from 47% to 80%, based on over 4,000 total observations. The mass of ABHR used per 100 patient-days in 3 intensive care units (ICUs) increased by 97%, 94%, and 70%; increases were sustained for 9 months. Self-reported compliance using the questionnaire did not change. Staff reported increased use of ABHR and increased satisfaction with hand hygiene practices and products.ConclusionsThe Six Sigma process was effective for organizing the knowledge, opinions, and actions of a group of professionals to implement the CDC's evidence-based hand hygiene practices in 4 ICUs. Several tools were developed for widespread use.
| S-EPMC2557134 | biostudies-literature