[Six Sigma driven QC management in hepatitis C serology]. / La méthodologie six sigma dans la gestion des contrôles de qualité en sérologie de l'hépatite C.

The Westgard quality control (QC) rules are often applied in infectious diseases serology to validate the quality of results, but this requires a reasonable tradeoff between maximum sensitivity to errors and minimum false rejections. This article, in addition to illustrate the six sigma methodology in the QC management of the (anti-HCV Architect®) test, it discusses the main influencing factors on sigma value. Data from low positive and in-kit control materials spreading over 6 months and using four reagent kits, were used to calculate the precision of the test. The difference between the control material reactivity and the cut-off defined the error budget. Sigma values were > 6, which indicates that the method produces four erroneous results per million tests. The application of the six sigma concept made it possible to argue the choice of the new QC strategy (use of 13S rule with one positive control) and to relax the existing QC rules. This work provides a framework for infectious diseases serology laboratories to evaluate tests performances against a quality requirement and design an optimal QC strategy.

Development and validation of an analytical method by HPLC-DAD for determination of caffeine in products based on guarana extracts (Paullinia cupana)

Abstract Guarana (Paullinia cupana) is a native plant from the Amazon whose seeds contain a high concentration of caffeine. Aqueous extract of guarana is widely used in the world. In this study, the objective was to develop and validate a High-Performance Liquid Chromatography method for the determination of caffeine in extracts and commercial beverages based on guarana. A sensitive, simple, and viable high performance liquid chromatographic method without the need of an analyte extraction procedure was developed and validated according to Brazilian and international requirements. The method presented high performance, fulfilling Brazilian and international requirements, in addition to allowing product compliance tests. Results confirmed high selectivity and linearity (>0.999) between 5 to 135 ug/mL, with no significant matrix effect. Detection and quantification limits were 0.02 µg/mL and 2 µg/mL, respectively. Precision was less than 4 %, and accuracy varied from 99.9-120 %. Applicability of the method was demonstrated by conducting a limited evaluation in products containing caffeine. Commercial extracts showed quite different caffeine levels, while carbonated drinks follow Brazilian and American recommendations. Our results indicate that the developed method can be used to evaluate the quality of the guarana extract and of products containing caffeine

Control de la calidad y ensayos de rendimiento de CromoCen® SALM según la norma ISO 11133:2014/Amd. 1: 2018 / Quality control and performance testing of CromoCen® SALM according to ISO 11133: 2014 / Amd.1: 2018

Introducción: En Cuba, se desarrolló un medio de cultivo cromogénico y fluorogénico, para la detección, aislamiento y diferenciación de Salmonella de otras bacterias Gram negativas. El método que emplea el medio fue validado y su uso se adoptó en una norma cubana. El aseguramiento de la calidad y el control del rendimiento de los medios garantizan la confiabilidad de los resultados analíticos. La norma ISO 11133 establece criterios mínimos y métodos para evaluarlos. Objetivo: Evaluar los criterios de control de la calidad y de rendimiento de CromoCen® SALM, establecidos en la ISO 11133:2014/Amd.1:2018, para demostrar su fiabilidad para el análisis microbiológico de los alimentos de consumo humano. Métodos: Se evaluaron los indicadores de calidad físico-químicos de tres lotes y se definió un conjunto de ellos que caracteriza la calidad del medio antes y después de terminado, así como la consistencia entre lotes. Para el ensayo de rendimiento se seleccionaron 10 cepas de diferentes géneros. Se determinó la relación de productividad, el factor de selectividad y la electividad de CromoCen® SALM, según la ISO 11133. Resultados: La evaluación físico-química mostró una consistencia entre lotes en color, homogeneidad, apariencia del polvo y del medio preparado. Los valores de contenido de humedad y pH se encontraron dentro de los valores establecidos para este producto. La relación de productividad de CromoCen® SALM con respecto al agar triptona soya, fue superior al 50 por ciento, mientras que el factor de selectividad resultó de 4. Se demostró que en el medio de cultivo se puede diferenciar un grupo representativo de géneros microbianos de Salmonella. Conclusiones: CromoCen® SALM cumple con los requisitos de calidad establecidos para este tipo de productos, según la ISO 11133 vigente. La correcta formulación de los lotes, así como el cumplimiento de los requisitos de calidad aseguran el funcionamiento adecuado para lo que fue diseñado(AU)

Introduction: In Cuba, a new chromogenic and fluorogenic culture medium was developed for the detection, isolation and differentiation of Salmonella from other Gram negative bacteria. The method and medium were validated and their use was adopted as a Cuban standard. Quality assurance and control of media is essential and mandatory to ensure the reliability of the results of the analysis in which they are used. ISO 11133 establishes minimum criteria and methods to evaluate them. Objective: To evaluate the quality and performance criteria of CromoCen® SALM, as recommended in ISO 11133:2014/Amd.1:2018 to demonstrate its reliability for the microbiological analysis of food for human consumption. Methods: The physical-chemical quality indicators of three batches were evaluated and a group of them was defined to characterize its quality before and after finishing, as well to evaluate the consistency between batches. For the performance test, 12 strains of different genera were selected. The productivity ratio, the selectivity factor and the electivity of CromoCen® SALM were determined. Results: The physico-chemical evaluation showed a consistency between batches in color, homogeneity, appearance of the powder and of the prepared medium. The moisture content and pH values ranged within the established values for this product. The productivity ratio of CromoCen® SALM with respect to tryptone soy agar was greater than 50 percent, while the selectivity factor was 4. It was shown that in the culture medium a representative group of Salmonella microbial genera can be differentiated. Conclusions: CromoCen® SALM meets the quality requirements established for this type of products, according to the current ISO 11133 standard. The correct formulation of the batches, as well as the fulfillment of the quality requirements ensure the proper functionality and match the design purpose(AU)

Improving Operating Room Efficiency Using the Six Sigma Methodology.

OBJECTIVE: To help improve operating room efficiency in a tertiary care facility, Six Sigma analysis was utilized. Six Sigma is a technique driven by data, methodology, and a philosophy of continuous improvement to help create a system in which 99.99966% of products are free from defects. This process helps to reduce variability and waste in production, while increasing quality and decreasing cost of the final product. METHODS: The steps of define, measure, analyze, improve, and control (DMAIC) methodology were used. Variables measured included close-to-cut time, patient-out to patient-in time, and room utilization. Statistical analysis was conducted, while an individual was sent to shadow various levels of operating room personnel to help recognize possible shortcomings in the system, including communication and coordination errors. RESULTS: Baseline results were recorded for each surgical specialty to help determine the specific needs of each OR team. Changes in workflow, such as staggered start anesthesia times, were recommended for each level of personnel based on statistical analysis and observation. Results were followed for several years with initial data showing success of the process. However, ongoing construction and resistance to change has prevented further review. CONCLUSION: While Six Sigma can be a valuable tool, it is essential to have a proper leadership team that includes all stake holders. The process requires horizontal and vertical leadership as well as buy-in from all individuals affected by the process. The synergy of these factors is key for success.

[Clinical management in nutrition units]. / Gestión clínica en las unidades de nutrición.

INTRODUCTION: Introduction: total quality management (TQM) is an element of excellence in the practice of clinical nutrition that is less recognized than others such as continuous training or research. Objective: to discuss the foundations of quality management tools such as TQM or continuous quality improvement, to describe major achievements in this field in nutrition units, and to define the main challenges for the future. Results: in recent years, at least 9 clinical nutrition units have implemented TQM with quality certification by an external agency, in most cases AENOR and in accordance with the ISO 9001 standard. This has meant reflecting on the activities carried out by the units in order to meet user expectations, to document said activities, to ensure a better understanding of the organization, and to define the responsibilities of all staff, avoiding errors and redundant activities, with the result of improved time management and resources. Conclusions: TQM contributes to excellence in clinical nutrition because it represents a useful tool to improve organization and results in an efficient way. Although much progress has been made, there still remains a lot of work to be done in terms of developing processes, indicators, standards, and especially the coding of disease related malnutrition (DRM), due to its very important impact on patient care.

INTRODUCCIÓN: Introducción: la gestión clínica es un elemento de excelencia en la práctica de la nutricion clínica que está menos reconocido que otros, como la formación continuada o la investigación. Objetivos: el objetivo de este artículo es exponer las bases de las herramientas de gestión de calidad, como son los programas de gestión clínica (PGC) o de mejora continua de la calidad; describir los principales logros en este campo en las unidades de nutrición, y plantear los principales retos para el futuro. Resultados: en los últimos años, al menos 9 unidades de nutrición han implantado PGC con certificación de calidad por parte de una agencia externa, en la mayoría de los casos AENOR y conforme a la norma ISO 9001. Esto ha supuesto hacer una reflexión sobre las actividades que realiza la unidad con el objetivo de satisfacer las expectativas de los usuarios, documentar dichas actividades, asegurar un mejor entendimiento de la organización y definir las responsabilidades de todo el personal, evitando errores y actividades redundantes, con el resultado de una mejor gestión del tiempo y los recursos. Conclusiones: los PGC contribuyen a la excelencia en la nutrición clínica porque constituyen una herramienta útil para mejorar la organización y nuestros resultados de un modo eficiente. Aunque se ha avanzado mucho, aún queda mucho trabajo por hacer en cuanto al desarrollo de procesos, indicadores, estándares y, especialmente, la codificación de la desnutrición relacionada con la enfermedad (DRE), por su repercusión importantísima en la atención de los pacientes.

A study on the management of needle-stick and sharps injuries based on total quality management in a tertiary hospital in western China.

OBJECTIVE: Based on the concept of total quality management, the practice of managing needle-stick and sharps injuries was analyzed to improve nursing quality. METHODS: Using total quality management, an improvement plan was completed. Standard operating procedures for infusion therapy and monitoring of the circulatory system were made to reduce the utilization of winged metal needles and the frequency of needle-stick injuries. From 2015 to 2018, four cross-sectional surveys were conducted on the use of winged metal needles, peripheral intravenous catheters, central venous catheters, peripherally inserted central catheters, and implantable venous access ports and the status of needle-stick and sharps injuries in our hospital during the 4 years. RESULTS: Four cross-sectional surveys showed that the percentage of winged metal needle utilization decreased significantly from 13% to 0.5%, and that of peripheral intravenous catheters increased from 77% to 87%. Zero tolerance of winged metal needles increased from 33 to 60 nursing units, an improvement rate of 81.82%. The number of needle-stick injuries decreased from 71 to 21, a decrease of 70.42%. Needle-stick injuries occurred mainly during waste disposal (34.71%) and needle withdrawal (18.18%) and when recapping needles (9.92%). CONCLUSION: Based on total quality management, the implementation of zero tolerance of winged metal needles is much better. The use of winged metal needles and the incidence of needle-stick injuries are reduced. Total quality management is of great clinical value in preventing needle-stick injuries.

Six Sigma revisited: We need evidence to include a 1.5 SD shift in the extraanalytical phase of the total testing process.

The Six Sigma methodology has been widely implemented in industry, healthcare, and laboratory medicine since the mid-1980s. The performance of a process is evaluated by the sigma metric (SM), and 6 sigma represents world class performance, which implies that only 3.4 or less defects (or errors) per million opportunities (DPMO) are expected to occur. However, statistically, 6 sigma corresponds to 0.002 DPMO rather than 3.4 DPMO. The reason for this difference is the introduction of a 1.5 standard deviation (SD) shift to account for the random variation of the process around its target. In contrast, a 1.5 SD shift should be taken into account for normally distributed data, such as the analytical phase of the total testing process; in practice, this shift has been included in all type of calculations related to SM including non-normally distributed data. This causes great deviation of the SM from the actual level. To ensure that the SM value accurately reflects process performance, we concluded that a 1.5 SD shift should be used where it is necessary and formally appropriate. Additionally, 1.5 SD shift should not be considered as a constant parameter automatically included in all calculations related to SM.

Using quality indicators to predict inspection ratings: cross-sectional study of general practices in England.

BACKGROUND: The Care Quality Commission regulates, inspects, and rates general practice providers in England. Inspections are costly and infrequent, and are supplemented by a system of routine quality indicators, measuring patient satisfaction and the management of chronic conditions. These indicators can be used to prioritise or target inspections. AIM: To determine whether this set of indicators can be used to predict the ratings awarded in subsequent inspections. DESIGN AND SETTING: This cross-sectional study was conducted using a dataset of 6860 general practice providers in England. METHOD: The indicators and first-inspection ratings were used to build ordered logistic regression models to predict inspection outcomes on the four-level rating system ('outstanding', 'good', 'requires improvement', and 'inadequate') for domain ratings and the 'overall' rating. Predictive accuracy was assessed using the percentage of correct predictions and a measure of agreement (weighted κ). RESULTS: The model correctly predicted 79.7% of the 'overall' practice ratings. However, 78.8% of all practices were rated 'good' on 'overall', and the weighted κ measure of agreement was very low (0.097); as such, predictions were little more than chance. This lack of predictive power was also found for each of the individual domain ratings. CONCLUSION: The poor power of performance of these indicators to predict subsequent inspection ratings may call into question the validity and reliability of the indicators, inspection ratings, or both. A number of changes to the way data relating to performance indicators are collected and used are suggested to improve the predictive value of indicators. It is also recommended that assessments of predictive power be undertaken prospectively when sets of indicators are being designed and selected by regulators.

Assessing the effects of lean on occupational health and safety in the Ready-Made Garment industry.

BACKGROUND: Garment manufacturers have been adopting lean manufacturing in order to increase productivity and competitiveness. However, the effects of lean on occupational health and safety (OHS) of the workers are not clear. In the literature, there is an ongoing debate about whether lean and OHS are complementary or contradictory. OBJECTIVE: The goal of this study was to contribute to the knowledge base about the relationship between lean and OHS in garment manufacturing. METHODS: The study follows an action research methodology including an intervention aimed at improving productivity and OHS in six garment manufacturers in Bangladesh. Both quantitative and qualitative methods were used for investigating the effect of lean tools on productivity and subsequently on OHS. RESULTS: We observed instances of improvements of OHS related to the application of three lean tools (VSM, 5 S, Time and Motion Study) in the factories. Furthermore, our results do not indicate negative health effect on workers' short-term muscular pain, but rather show a statistically significant improvement of workers' health. CONCLUSIONS: The results suggest that it is possible to apply lean without adverse effects for workers, if OHS risks are taken into consideration. However, possible long-term effects on workers' health need to be further investigated.

Clinical Validation of Quality Improvements Using the Six Sigma Concept: A Case Study for Deep Brain Stimulation in Parkinson's Disease.

BACKGROUND: The Six Sigma concept allows for the evaluation of quality changes after the implementation of new technical equipment or adjustment of perioperative procedures. Exemplarily, we applied this method for quality assessment in deep brain stimulation surgery (DBS) for Parkinson's disease. METHODS: The medical procedure and possible errors were registered. Then, 6 critical-to-quality characteristics regarding clinical outcome, surgical precision, and the surgical process were measured. The surgical procedure was then optimized in 2 steps, and its measurement, along with the analysis, was repeated twice. RESULTS: By optimizing perioperative settings, the operation time could be reduced, and the precision of the lead placement could be increased. Clinical outcome, as measured by improvement in UPDRS-III, IV, and reduction of medication could also be improved with smaller required stimulation voltage. With directional leads considerable reduction of medication was achieved in 97% of patients (σ-value 3.39) compared to 83.7% (σ-value 2.53) with nondirectional leads. CONCLUSION: This study shows that the Six Sigma concept is a suitable quality tool to analyze and improve treatment quality of complex medical procedures such as lead positioning in DBS surgery in clinical routine. Our results suggest that directional leads in subthalamic nucleus DBS may have a favorable impact on patients' outcome.

Design and implementation of quality control plans that integrate moving average and internal quality control: incorporating the best of both worlds.

Background New moving average quality control (MA QC) optimization methods have been developed and are available for laboratories. Having these methods will require a strategy to integrate MA QC and routine internal QC. Methods MA QC was considered only when the performance of the internal QC was limited. A flowchart was applied to determine, per test, whether MA QC should be considered. Next, MA QC was examined using the MA Generator (www.huvaros.com), and optimized MA QC procedures and corresponding MA validation charts were obtained. When a relevant systematic error was detectable within an average daily run, the MA QC was added to the QC plan. For further implementation of MA QC for continuous QC, MA QC management software was configured based on earlier proposed requirements. Also, protocols for the MA QC alarm work-up were designed to allow the detection of temporary assay failure based on previously described experiences. Results Based on the flowchart, 10 chemistry, two immunochemistry and six hematological tests were considered for MA QC. After obtaining optimal MA QC settings and the corresponding MA validation charts, the MA QC of albumin, bicarbonate, calcium, chloride, creatinine, glucose, magnesium, potassium, sodium, total protein, hematocrit, hemoglobin, MCH, MCHC, MCV and platelets were added to the QC plans. Conclusions The presented method allows the design and implementation of QC plans integrating MA QC for continuous QC when internal QC has limited performance.

Contextual Conditions and Performance Improvement in Primary Care.

BACKGROUND: Although organizational context can affect the implementation of quality initiatives, we know less about the influence of contextual conditions on quality outcomes. We examined organizational features of primary care clinics that achieved greatest performance improvements after implementing Lean redesigns. METHODS: We used operational data and baseline (ie, pre-Lean implementation) surveys of 1333 physicians and staff in 43 primary care clinics located across a large ambulatory care system. Segmented regression with interrupted time series analysis was used to identify clinics with highest improvements in workflow efficiency, physician productivity, and patient satisfaction following Lean redesign. We conducted independent-samples t tests to identify contextual features of clinics that showed greatest improvements in performance outcomes. RESULTS: Clinics with highest increases in efficiency had most prior experience with quality improvement, compared with all other clinics. Efficiency gains were also found in clinics reporting highest levels of burnout and work stress prior to redesign. Highest improvements in physician productivity were associated with a history of change, staff participation, and leadership support for redesigns. Greatest improvements in patient satisfaction occurred in least stressful environments with highest levels of teamwork, staff engagement/efficacy, and leadership support. CONCLUSIONS: Our findings encourage careful evaluation of clinic characteristics and capacity to effectively implement redesigns. Such evaluations may help leaders select interventions most appropriate for certain clinics, while identifying others that may need extra support with implementing change.

Value Flow Map: application and results in the disinfection center.

OBJECTIVE: To identify and eliminate steps that do not add value for customers in the disinfection center. METHOD: We applied the Lean tool: Value Flow Map, using the concepts of gemba and kaizen in the work process of the disinfection unit for ventilatory care materials, aiming at improving such process. After performing a training with the team on the Lean concepts described above, applying the Value Flow Map in the gemba, analyzing the opportunities for improvement, and approving the changes, the Value Flow Map of the future state was devised and changes were implemented. RESULT: The time of the disinfection process was reduced in 2h37 and the financial resources required also decreased, in R$ 809.08/month. CONCLUSION: The application of Lean concepts presented positive results for the elimination of wastages in the disinfection center.

Value Flow Map: application and results in the disinfection center / Mapa de la Cadena de Valor: aplicación y resultados en el centro de desinfección / Mapa de Fluxo de Valor: aplicação e resultados na central de desinfecção

ABSTRACT Objective: To identify and eliminate steps that do not add value for customers in the disinfection center. Method: We applied the Lean tool: Value Flow Map, using the concepts of gemba and kaizen in the work process of the disinfection unit for ventilatory care materials, aiming at improving such process. After performing a training with the team on the Lean concepts described above, applying the Value Flow Map in the gemba, analyzing the opportunities for improvement, and approving the changes, the Value Flow Map of the future state was devised and changes were implemented. Result: The time of the disinfection process was reduced in 2h37 and the financial resources required also decreased, in R$ 809.08/month. Conclusion: The application of Lean concepts presented positive results for the elimination of wastages in the disinfection center.

RESUMEN Objetivo: identificar y eliminar los pasos que no agregan valor para los clientes en el centro de desinfección. Método: aplicamos la herramienta Lean: mapa de la cadena de valor, conceptos de gemba y kaizen, en el proceso de trabajo de la unidad de desinfección para materiales de asistencia ventilatoria con el objetivo de mejorar el proceso. Después de realizar una capacitación con el equipo sobre los conceptos Lean descritos anteriormente, aplicamos el Mapa de la cadena de valor en el gemba, analizamos las oportunidades de mejora y aprobamos los cambios; se diseñó el Mapa de la cadena de valor del estado futuro y se implementaron los cambios. Resultado: el tiempo del proceso de desinfección se redujo en dos horas y treinta y siete minutos, y los recursos financieros requeridos también disminuyeron en R$ 809,08/mes. Conclusión: la aplicación de los conceptos Lean presentó resultados positivos para la eliminación de desperdicios en el centro de desinfección.

RESUMO Objetivo: identificar e eliminar as etapas que não agregam valor ao cliente na central de desinfecção. Método: foi aplicada a ferramenta Lean: Mapa de Fluxo de Valor, utilizando os conceitos Gemba e Kaizen no processo de trabalho da unidade de desinfecção de materiais para uso na assistência ventilatória com o intuito de melhorar o processo de trabalho. Foi realizada a capacitação da equipe em relação aos conceitos Lean descritos acima, foi aplicado o Mapa de Fluxo de Valor no Gemba, foram analisadas as oportunidades de melhoria e, após, aprovação das alterações, foi desenhado o Mapa de Fluxo de Valor do estado futuro e implementadas as mudanças. Resultado: obteve-se redução de tempo em 2h37 no processo de desinfecção e redução de recursos financeiros em R$ 809,08 reais/mês. Conclusão: a aplicação de conceitos Lean apresentou resultados positivos na eliminação de desperdícios na central de desinfecção.