A scoping review of continuous quality improvement in healthcare system: conceptualization, models and tools, barriers and facilitators, and impact.

BACKGROUND: The growing adoption of continuous quality improvement (CQI) initiatives in healthcare has generated a surge in research interest to gain a deeper understanding of CQI. However, comprehensive evidence regarding the diverse facets of CQI in healthcare has been limited. Our review sought to comprehensively grasp the conceptualization and principles of CQI, explore existing models and tools, analyze barriers and facilitators, and investigate its overall impacts. METHODS: This qualitative scoping review was conducted using Arksey and O'Malley's methodological framework. We searched articles in PubMed, Web of Science, Scopus, and EMBASE databases. In addition, we accessed articles from Google Scholar. We used mixed-method analysis, including qualitative content analysis and quantitative descriptive for quantitative findings to summarize findings and PRISMA extension for scoping reviews (PRISMA-ScR) framework to report the overall works. RESULTS: A total of 87 articles, which covered 14 CQI models, were included in the review. While 19 tools were used for CQI models and initiatives, Plan-Do-Study/Check-Act cycle was the commonly employed model to understand the CQI implementation process. The main reported purposes of using CQI, as its positive impact, are to improve the structure of the health system (e.g., leadership, health workforce, health technology use, supplies, and costs), enhance healthcare delivery processes and outputs (e.g., care coordination and linkages, satisfaction, accessibility, continuity of care, safety, and efficiency), and improve treatment outcome (reduce morbidity and mortality). The implementation of CQI is not without challenges. There are cultural (i.e., resistance/reluctance to quality-focused culture and fear of blame or punishment), technical, structural (related to organizational structure, processes, and systems), and strategic (inadequate planning and inappropriate goals) related barriers that were commonly reported during the implementation of CQI. CONCLUSIONS: Implementing CQI initiatives necessitates thoroughly comprehending key principles such as teamwork and timeline. To effectively address challenges, it's crucial to identify obstacles and implement optimal interventions proactively. Healthcare professionals and leaders need to be mentally equipped and cognizant of the significant role CQI initiatives play in achieving purposes for quality of care.

Starting continuous improvement; creating a common understanding of stroke care delivery in a general hospital.

BACKGROUND: Continuous improvement is based on fostering practitioners' suggestions to modify their own work processes This improvement strategy is widely applied in healthcare but difficult to maintain. The cross-disciplinary nature of many care processes constitutes an extra impediment. METHODS: The study had an explorative design with a qualitative single-case approach. The case presents a project to improve the treatment of patients with thrombotic stroke. Data was obtained via hands on involvement, documents, observations, and interviews with participants in a cross-functional improvement group. A thematic analysis method was employed. RESULTS: Through learning how tasks were carried out in other disciplines, the participants developed a common understanding of why it took so long to provide treatment to stroke patients. These insights were used to implement practical changes, leading to immediate improvements in stroke care delivery. The results were fed back so that successes became visible. Participants' understandings of the local context enabled them to convince peers of the rationale of changes, setting in motion a permanent improvement structure. The participants considered that mapping and then assessing the entire workflow across disciplines were relevant methods for improving the quality of patient care. CONCLUSION: Starting an improvement project in a cross disciplinary environment requires deep engagement on the part of professionals. A quintessential prerequisite is therefore the realization that the quality of care depends on cross-disciplinary cooperation. A facilitated learning arena needs to (1) create insights into each other's colleagues' tasks and process interdependencies, (2) increase understanding of how the distribution of tasks among specialist units affects the quality of care, and (3) frequently report and provide feedback on results to keep the process going.

Use of the DMAIC Lean Six Sigma quality improvement framework to improve beta-lactam antibiotic adequacy in the critically ill.

Beta-lactam antibiotics are widely used in the intensive care unit due to their favorable effectiveness and safety profiles. Beta-lactams given to patients with sepsis must be delivered as soon as possible after infection recognition (early), treat the suspected organism (appropriate), and be administered at a dose that eradicates the infection (adequate). Early and appropriate antibiotic delivery occurs in >90% of patients, but less than half of patients with sepsis achieve adequate antibiotic exposure. This project aimed to address this quality gap and improve beta-lactam adequacy using the Define, Measure, Analyze, Improve, and Control Lean Six Sigma quality improvement framework. A multidisciplinary steering committee was formed, which completed a stakeholder analysis to define the gap in practice. An Ishikawa cause and effect (Fishbone) diagram was used to identify the root causes and an impact/effort grid facilitated prioritization of interventions. An intervention that included bundled education with the use of therapeutic drug monitoring (TDM; i.e. drug-level testing) was projected to have the highest impact relative to the amount of effort and selected to address beta-lactam inadequacy in the critically ill. The education and TDM intervention were deployed through a Plan, Do, Study, Act cycle. In the 3 months after "go-live," 54 episodes of beta-lactam TDM occurred in 41 unique intensive care unit patients. The primary quality metric of beta-lactam adequacy was achieved in 94% of individuals after the intervention. Ninety-four percent of clinicians gauged the education provided as sufficient. The primary counterbalance of antimicrobial days of therapy, a core antimicrobial stewardship metric, was unchanged over time (favorable result; P = .73). Application of the Define, Measure, Analyze, Improve, and Control Lean Six Sigma quality improvement framework effectively improved beta-lactam adequacy in critically ill patients. The approach taken in this quality improvement project is widely generalizable to other drugs, drug classes, or settings to increase the adequacy of drug exposure.

What are the perceptions of faculty and academic leaders regarding the impact of accreditation on the continuous quality improvement process of undergraduate medical education programs at Caribbean medical schools?

BACKGROUND: Accreditation and regulation are meant for quality assurance in higher education. However, there is no guarantee that accreditation ensures quality improvement. The accreditation for Caribbean medical schools varies from island to island, and it could be mandatory or voluntary, depending on local government requirements. Caribbean medical schools recently attained accreditation status to meet the Educational Commission for Foreign Medical Graduates (ECFMG) requirements by 2024. Literature suggests that accreditation impacts ECFMG certification rates and medical schools' educational processes. However, no such study has examined accreditation's impact on continuous quality improvement (CQI) in medical schools. This study aims to gather the perceptions and experiences of faculty members and academic leaders regarding the impact of accreditation on CQI across Caribbean medical schools. METHODS: This qualitative phenomenological study inquiries about the perceptions and experiences of faculty and academic leaders regarding accreditation's impact on CQI. Purposive and snowball sampling techniques were used. Participants were interviewed using a semi-structured interview method. Fifteen participants were interviewed across ten Caribbean medical schools representing accredited medical schools, accreditation denied medical schools, and schools that never applied for accreditation. Interviews were audio recorded, and thematic data analysis was conducted. RESULTS: Thematic analysis yielded six themes, including accreditation and CQI, CQI irrespective of accreditation, faculty engagement and faculty empowerment in the CQI process, collecting and sharing data, ECFMG 2024 requirements, and organizational structure of CQI. CONCLUSIONS: There is ongoing quality improvement at Caribbean medical schools, as perceived by faculty members and academic leaders. However, most of the change process is happening because of accreditation, and the quality improvement is due to external push such as accreditation rather than internal motivation. It is recommended that Caribbean medical schools promote internal quality improvement irrespective of accreditation and embrace the culture of CQI.

A lean approach for improving medicines management in Australia's first cardiac hospital inventory system.

BACKGROUND: Medicines are the cornerstone of healthcare. Lean methodology approach such as Value Stream Mapping (VSM) is being used in healthcare to manage resources wisely to ensure sustainability of medicines and resources. The aim of this quality improvement study was to evaluate and improve the medication management and hospital imprest supply processes in Australia's first dedicated cardiology hospital using VSM. METHOD: We conducted a review of our medicine supply processes at a 180-bed cardiology hospital in Australia. We followed a lean methodology approach over a 4-month period from February to May 2023 and evaluated the outcome of our improvements for another 4 months from July to October 2023. We used VSM to identify non-value adding activities. Cost of medicines holding was calculated, as well as time taken to complete supply processes, pre and post. RESULTS: Pharmacy department stockholdings reduced by 51%; p = 0.000121 (from $539,662 to $275,406). Time taken to manage the inventory system also reduced by 42%; p = 0.025762 (from 148 h/month to 62 h/month). Lean methodology such as VSM can facilitate cost-effective and sustainable system improvements for pharmacy procurement systems.

Optimizing workflow of urgent stroke endovascular intervention: A focused lean six sigma project.

INTRODUCTION: Urgent endovascular intervention is currently accepted as the primary and critical therapeutic approach to patients whose acute ischemic stroke results from a large arterial occlusion (LAO). In this context, one of the quality metrics most widely applied to the assessment of emergency systems performance is the "door-to-puncture" (D-P) time. We undertook a project to identify the subinterval of the D-P metric causing the most impact on workflow delays and created a narrowly focused project on improving such subinterval. METHODS: Using the DMAIC (i.e., define, measure, analyze, improve and control) approach, we retrospectively reviewed our quality stroke data for calendar year (CY) 2021 (i.e., baseline population), completed a statistical process control assessment, defined the various subintervals of the D-P interval, and completed a Pareto analysis of their duration and their proportional contribution to the D-P interval. We retooled our workflow based on these analyses and analyzed the data resulting from its implementation between May and December 2022 (i.e., outcome population). RESULTS: The baseline population included 87 patients (44 men; mean age = 67.2 years). Their D-P process was uncontrolled, and times varied between 35-235 minutes (Mean = 97; SD = 38.40). Their door to angiography arrival (D-AA) subinterval was significantly slower than their arrival to puncture (AA-P) (73.4 v. 23.5 minutes; p < 0.01), accounted for 73% of the average length of the D-P interval. The group page activation to angiography arrival (GP-AA) subinterval accounted for 41.5% of the entire D-AA duration, making it the target of our project. The outcome population originally consisted of 38 patients (15 men; mean age = 70.3 years). Their D-P process was controlled, its times varying between 43-177 minutes (Mean = 85.8; SD = 34.46), but not significantly difference than the baseline population (p = 0.127). Their target subinterval GP-AA varied between 0-37 minutes and was significantly improved from the baseline population (Mean = 13.21 v. 29.68; p < 0.001). CONCLUSIONS: It seems feasible and reasonable to analyze the subinterval components of complex quality metrics such as the D-P time and carry out more focused quality improvement projects. Care must be exercised when interpreting the impact on overall system performance, due to unexpected variations within interdependent subprocesses. The application of a robust and comprehensive LSS continuous quality improvement process in any CSC will have to include individualized focused projects that simultaneously control the different components of overall system performance.

Factors driving differences in the adoption of quality management practices among hospitals: A two-phase, sequential mixed-methods analysis.

BACKGROUND: Although all hospitals aim to deliver high-quality care, there is considerable variation in their adoption of quality management (QM) practices. Organizational and environmental factors are known to drive strategic decision-making in hospitals, but their impact on the adoption of QM practices remains unclear. PURPOSE: Our study aims to identify multiple organizational and environmental factors that explain variation in the adoption of QM practices among hospitals and to explore mechanisms underlying these relationships. METHODOLOGY: We conducted a two-phase, sequential mixed-methods study of German acute care hospitals. The quantitative phase used between-effects regressions to identify factors explaining variation in the number of QM practices adopted by hospitals from 2015 to 2019. The qualitative phase used semistructured interviews with quality managers to gain in-depth insights. RESULTS: The number of QM practices adopted by a hospital was significantly associated with factors like hospital size and the presence of an emergency department or QM steering committee. Our qualitative findings highlighted potential mechanisms such as the presence of an emergency department serving as a proxy for organizational complexity or urgency of case-mix. CONCLUSION: We provide an overview of factors driving QM adoption in hospitals, extending beyond the focus on single factors in previous research. Future studies could explore additional factors highlighted by our interviewees. PRACTICE IMPLICATIONS: Our results can inform interventions to strengthen QM in hospitals and guide future research on this topic.

[Discharge management strategies in German general hospitals : A nationwide survey of professionals responsible for clinical risk management]. / Strategien des Entlassmanagements in deutschen Allgemeinkrankenhäusern : Deutschlandweite Befragung von Verantwortlichen des klinischen Risikomanagements.

BACKGROUND: Transitions from inpatient care are associated with risks for the safety of patients. In 2017, the framework agreement on discharge management was legally defined. There is currently a lack of empirical data in Germany on the implementation of measures to ensure safe transitions of patients after inpatient care. The aim of this study is to provide an overview of the discharge management strategies implemented by German general hospitals. METHODS: Between March and May 2022, specific discharge management strategies as well as structural and organizational characteristics were assessed in a nationwide survey of 401 general hospitals, and descriptive statistics and group comparisons were performed. RESULTS: Seven of nine strategies surveyed were implemented in > 95% of all hospitals. The evaluation of discharge planning was only implemented in 61% of the hospitals, and systematic documentation, analysis, and evaluation of readmissions in 54%. Hospitals with a higher number of hospital beds reported significantly less often about "early contact with follow-up care providers" and "organization of a seamless transition to follow-up care." DISCUSSION: A large part of the strategies in discharge management from inpatient treatment is implemented in German general hospitals. However, measures for evaluation and the systematic analysis of discharge processes and readmissions of patients have only been partially implemented. However, these are necessary to systematically evaluate and potentially improve the discharge processes.

[Establishment of the quality management system for occupational diseases diagnosis].

The quality management system of occupational diseases diagnosis is belonged to one part of the hospital quality management system. It must be adhered to the quality management concept of comprehensive, full staff and whole process. To establish and improve the quality management system should be included: (1) Formulated a quality management manual for occupational disease diagnosis, including organization construction, rules and regulations, responsibilities, work flow, operating procedures and clinical pathways, standard instrument, etc. (2) Managed the document of occupational diseases diagnosis. (3) The continuous improvement of quality management. The quality management of occupational diseases diagnosis focuses on the mastery and implementation of the manual by employees, which is reflected in the continuous improvement of daily work, internal assessment and external assessment.

Lean and Six Sigma as continuous quality improvement frameworks in the clinical diagnostic laboratory.

Processes to enhance customer-related services in healthcare organizations are complex and it can be difficult to achieve efficient patient-focused services. Laboratories make an integral part of the healthcare service industry where healthcare providers deal with critical patient results. Errors in these processes may cost a human life, create a negative impact on an organization's reputation, cause revenue loss, and open doors for expensive lawsuits. To overcome these complexities, healthcare organizations must implement an approach that helps healthcare service providers to reduce waste, variation, and work imbalance in the service processes. Lean and Six Sigma are used as continuous process improvement frameworks in laboratory medicine. Six Sigma uses an approach that involves problem-solving, continuous improvement and quantitative statistical process control. Six Sigma is a technique based on the DMAIC process (Define, Measure, Analyze, Improve, and Control) to improve quality performance. Application of DMAIC in a healthcare organization provides guidance on how to handle quality that is directed toward patient satisfaction in a healthcare service industry. The Lean process is a technique for process management in which waste reduction is the primary purpose; this is accomplished by implementing waste mitigation practices and methodologies for quality improvement. Overall, this article outlines the frameworks for continuous quality and process improvement in healthcare organizations, with a focus on the impacts of Lean and Six Sigma on the performance and quality service delivery system in clinical laboratories. It also examines the role of utilization management and challenges that impact the implementation of Lean and Six Sigma in clinical laboratories.

Quality Management System in Clinical Digital Pathology Operations at a Tertiary Cancer Center.

Digital pathology workflows can improve pathology operations by allowing reliable and fast retrieval of digital images, digitally reviewing pathology slides, enabling remote work and telepathology, use of computer-aided tools, and sharing of digital images for research and educational purposes. The need for quality systems is a prerequisite for successful clinical-grade digital pathology adoption and patient safety. In this article, we describe the development of a structured digital pathology laboratory quality management system (QMS) for clinical digital pathology operations at Memorial Sloan Kettering Cancer Center (MSK). This digital pathology-specific QMS development stemmed from the gaps that were identified when MSK integrated digital pathology into its clinical practice. The digital scan team in conjunction with the Department of Pathology and Laboratory Medicine quality team developed a QMS tailored to the scanning operation to support departmental and institutional needs. As a first step, systemic mapping of the digital pathology operations identified the prescan, scan, and postscan processes; instrumentation; and staffing involved in the digital pathology operation. Next, gaps identified in quality control and quality assurance measures led to the development of standard operating procedures and training material for the different roles and workflows in the process. All digital pathology-related documents were subject to regulatory review and approval by departmental leadership. The quality essentials were developed into an extensive Digital Pathology Quality Essentials framework to specifically address the needs of the growing clinical use of digital pathology technologies. Using the unique digital experience gained at MSK, we present our recommendations for QMS for large-scale digital pathology operations in clinical settings.

Evaluation of analytical performance of homocysteine LC-MS/MS assay and design of internal quality control strategy.

OBJECTIVES: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) has become a common technique in clinical laboratories in recent years. Because most methods are laboratory-developed tests (LDTs), their reproducibility and quality control (QC) have been controversial. In this study, Westgard Sigma Rules were used to evaluate the analytical performance and establish an individualised internal QC (IQC) strategy for these LDTs. METHODS: Taking the LC-MS/MS LDT method for homocysteine (Hcy) as an example, the 'desirable specifications' from the Biological Variation Database were used as quality goals. Based on the external quality assessment (EQA) samples, bias was calculated and the coefficient of variation (CV) was also calculated by IQC measurements for six consecutive months. The analytical performance was evaluated by calculated sigma metrics and an IQC strategy was designed using the Westgard Sigma Rules with run size. RESULTS: Over 116 days within 6 months, a total of 850 data points were collected for each of IQC 1 and IQC 2. The monthly coefficient of variation CV% was 2.57-4.01%, which was non-significant (p-value: 0.75). The absolute bias% for IQC1 and IQC2 was 1.23 and 1.87%, respectively. The allowable total error (TEa) was selected as 15.5%, Sigma metrics were 4.02 and 4.30, and the analytical performance was 'Good'. The 13s/22s/R4s/41s multi rules (n=4, r=1) with a run size of 200 samples were suggested for the Hcy IQC scheme. The quality goal index (QGI) values were over 1.2, indicating that trueness needed to be improved. CONCLUSIONS: The analytical performance of the Hcy LC-MS/MS LDT conformed to the Six Sigma rating level, achieving 'good' (four Sigma). Clinical practice indicated that calibration bias was the primary factor affecting trueness.

Quality standards and internal quality control practices in medical laboratories: an IFCC global survey of member societies.

OBJECTIVES: The trueness and precision of clinical laboratory results are ensured through total quality management systems (TQM), which primarily include internal quality control (IQC) practices. However, quality practices vary globally. To understand the current global state of IQC practice and IQC management in relation to TQM the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC member countries on IQC practices and management. METHODS: The survey included 16 questions regarding IQC and laboratory TQM practices and was distributed to IFCC full and affiliate member countries (n=110). A total of 46 (41.8 %) responses were received from all regions except North America. RESULTS: Of the responding countries, 78.3 % (n=36) had legislative regulations or accreditation requirements governing medical laboratory quality standards. However, implementation was not mandatory in 46.7 % (n=21) of responding countries. IQC practices varied considerably with 57.1 % (n=28) of respondents indicating that they run 2 levels of IQC, 66.7 % (n=24) indicating they run IQC every 24 h and 66.7 % (n=28) using assay manufacturer IQC material sources. Only 29.3 % (n=12) of respondents indicated that every medical laboratory in their country has written IQC policies and procedures. By contrast, 97.6 % (n=40) of responding countries indicated they take corrective action and result remediation in the event of IQC failure. CONCLUSIONS: The variability in TQM and IQC practices highlights the need for more formal programs and education to standardize and improve TQM in medical laboratories.

External quality assessment practices in medical laboratories: an IFCC global survey of member societies.

OBJECTIVES: Clinical laboratory results are required for critical medical decisions, underscoring the importance of quality results. As part of total quality management, external quality assessment (EQA) is a vital component to ensure laboratory accuracy. The goal of this survey was to evaluate the current status of global laboratory quality systems and assess the need for implementation, expansion, or harmonization of EQA programs (EQAP) for Clinical Chemistry and Laboratory Medicine. METHODS: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC full and affiliate members (n=110) on laboratory quality practice. A total of 41 (37.3%) countries representing all IFCC regions except North America provided responses about EQA availability and practices. RESULTS: All 41 countries perform EQA, 38 reported that their laboratories had EQA policies and procedures, and 39 further act/evaluate unacceptable EQA results. 39 countries indicated they have international and/or national EQAP and 30 use alternative performance assessments. EQA frequency varied among countries. Generally, an EQAP provided the EQA materials (40/41) with four countries indicating that they did not have an EQAP in their country. CONCLUSIONS: Globally, most laboratories participate in an EQAP and have defined quality procedures for EQA. There remain gaps in EQA material availability and implementation of EQA as a part of a total laboratory quality system. This survey highlights the need for education, training, and harmonization and will guide efforts of the IFCC TF-GLQ in identifying areas for enhancing global laboratory quality practices.

Investigating the quality of hemovigilance process using the first two steps of Six Sigma model: a cross-sectional study.

BACKGROUND AND PURPOSE: Hemovigilance is a set of monitoring methods that covers the blood transfusion chain, from collecting blood and blood products to monitoring the blood recipients. To this end, any error in this process can have serious and irreparable consequences for patients. The present study aimed to investigate the quality of hemovigilance process in Iran, using the first two steps of Six Sigma model. METHODS: This was a quantitative cross-sectional study that was conducted over 6 months (from August 20, 2021, to February 20, 2022) at Afzalipour Hospital in Iran, using the first two steps of Six Sigma model. The study population comprised of all inpatients who needed blood or blood product transfusion in various departments of Afzalipour Hospital, among whom 477 patients were selected via stratified sampling in three shifts (morning, evening, and night). The datasheet was used to record errors in the three shifts. This research was conducted, using the DMAIC cycle's "define" and "measure" steps. RESULTS: In the define step, the hemovigilance process at Afzalipour Hospital was divided into two categories of normal process and emergency process. Each of these processes consists of several sub-processes, including "phlebotomy," "requesting blood and blood products from the department," "preparation of application by the blood bank," " sending a request from the blood bank to the blood transfusion center," "transfusing blood and blood products," and "returning the blood and blood products to the blood bank and waste disposal." In the measure step, the quality of hemovigilance process was evaluated based on sub-processes and labels at morning, evening and night shifts. The sub-process of sending a request from the blood bank to the blood transfusion center had the highest error rate with a sigma level of 1.5. Also, the evening and night shifts had a sigma level of 1.875, and the clinical and registration labels had a sigma level of 1.875. The overall sigma level of hemovigilance process was calculated to be 2. CONCLUSION: The results of this study showed that the quality of hemovigilance process at Afzalipour Hospital was poor. By employing the first two steps of Six Sigma method, we identified the existing errors in the hemovigilance process of Afzalipour hospital in order to assist hospital managers to take the necessary measures to improve this process.

Airway management in paediatric emergencies outside of an intensive care setting: a quality improvement project using Lean/Six Sigma methodology.

Use of a Lean/Six Sigma methodology in a quality improvement project to reduce variation and improve safety in airway management outside of the intensive care environment in a tertiary paediatric hospital.

[Newborn blood spot screening (NBS) in Germany : Status quo and presentation of a concept for further development]. / Neugeborenen-Screening aus Trockenblut (NBS) in Deutschland : Status quo und Vorstellung eines Konzeptes zur Weiterentwicklung.

Newborn screening from dried blood spots (NBS) is a highly effective secondary prevention measure that has been established for many years. Against the background of the inclusion of "new diseases" that meet the screening criteria, a concept for the further advancement of NBS was developed on behalf of the GKV-Spitzenverband. This was based on a systematic literature review and a survey of the status quo of NBS in Germany using quantitative and qualitative methods.It is essential for the success of NBS that all newborns affected by a target disease are diagnosed and treated at an early stage and that the harm to be expected with each screening (e.g., due to false positive findings) is kept as low as possible. This requires the organisation of screening in the sense of an integrated programme through central coordination with standardised structures, continuous quality management and digitalisation in line with data protection requirements.Although in general NBS is being implemented successfully in Germany, the research project presented here also reveals weaknesses and a need for action. Proposals and recommendations were compiled in a concept paper, which shows approaches for further development of NBS in line with the current state of research in consideration of changing demands on the infrastructure and processes in the health system. This review article summarises the challenges, current status and possible solutions for the central topics of the concept paper.

Extreme Makeover in a health center: LEAN methodology applied to clinical practice.

INTRODUCTION: The LEAN methodology is an integration of methods and tools developed in the 90s in the industrial sector. It aims to reduce waste (things that don't add value to the final product), add worth and work towards continuous quality improvement. METHODS: LEAN tools to improve the clinical practice of a health center include:5S methodology: helps organize, clean, develop and maintain a productive work environment;'Spaghetti' diagram: displays the movement and distance that a given element has to travel throughout the entire process; andTime and motion studies: measure the various times associated with the process and the associated motion. RESULTS: The LEAN methodology made it possible to manage space and time efficiently and optimally. There was a substantial reduction in both the time and number of trips for not only the health professionals but also for the patients. DISCUSSION: Clinical practice should focus on the permission of continuous quality improvement. The LEAN methodology, through its different tools, generates an increase in productivity and profitability. It promotes teamwork through multidisciplinary teams and the empowerment and training of employees. The implementation of the LEAN methodology improved the practices and strengthened the team spirit based on everyone's participation, because the whole is greater than the sum of the parts.

Six Sigma in blood transfusion services: A dream too big in a third world country?

BACKGROUND AND OBJECTIVES: Transfusion errors can occur anywhere from blood donation to final blood transfusion. They are a source of increased cost and patient mortality. Automated workflows can reduce transcription errors, but resource-poor centres still use semi-automated/manual method for testing including manual labelling of column agglutination cards/testing tubes. Missing out any details on these cards can lead to errors in reporting results, wastage and loss of resources and effort. The aim of this study was to implement Six Sigma DMAIC (Define, Measure, Analyse, Improve and Control) methodology to reduce transcription errors while labelling gel card in immunohaematology lab to zero defect. MATERIALS AND METHODS: In this prospective study, transcription errors while manually performing 200 tests with 1400 opportunities were analysed. Baseline variables like number of errors, defects per million opportunities and sigma level in our current setup were measured. With the application of DMAIC methodology, root cause analysis for each error using Ishikawa diagram and structured Interviews were done to identify causes. A multipronged approach to deal with errors was done to improve critical areas using brainstorming sessions and developing training sheets for practice. After implementing the changes, baseline variables were reanalysed. RESULTS: Application of DMAIC resulted in an overall reduction in defects from 34.86% to 0.56% with sigma level improvement from 1.89 to 4.08. CONCLUSION: Six Sigma methodology can be used in a resource-poor setting even with lack of automation to ensure error-free process flow.

Practical application of European biological variation combined with Westgard Sigma Rules in internal quality control.

OBJECTIVES: Westgard Sigma Rules is a statistical tool available for quality control. Biological variation (BV) can be used to set analytical performance specifications (APS). The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) regularly updates BV data. However, few studies have used robust BV data to determine quality goals and design a quality control strategy for tumor markers. The aim of this study was to derive APS for tumor markers from EFLM BV data and apply Westgard Sigma Rules to establish internal quality control (IQC) rules. METHODS: Precision was calculated from IQC data, and bias was obtained from the relative deviation of the External quality assurance scheme (EQAS) group mean values and laboratory-measured values. Total allowable error (TEa) was derived using EFLM BV data. After calculating sigma metrics, the IQC strategy for each tumor marker was determined according to Westgard Sigma Rules. RESULTS: Sigma metrics achieved for each analyte varied with the level of TEa. Most of these tumor markers except neuron-specific enolase reached 3σ or better based on TEamin. With TEades and TEaopt set as the quality goals, almost all analytes had sigma values below 3. Set TEamin as quality goal, each analyte matched IQC muti rules and numbers of control measurements according to sigma values. CONCLUSIONS: Quality goals from the EFLM BV database and Westgard Sigma Rules can be used to develop IQC strategy for tumor markers.