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.

Evaluación de la gestión de calidad en la red de bibliotecas médicas de Villa Clara / Evaluation of quality management in Villa Clara medical library network

La calidad es una exigencia vigente a nivel mundial en el área de la educación, a su vez constituye un indicador fundamental para las instituciones educativas, sujetas a proporcionar un servicio de excelencia. Por ello resulta necesario evaluar la gestión de calidad en las bibliotecas médicas de Villa Clara, de manera tal que se contribuya al mejoramiento de su funcionamiento y lograr un mayor nivel de satisfacción de las necesidades informativas de sus usuarios. Se tomaron como referentes teóricos el modelo de evaluación de bibliotecas universitarias cubanas, y los documentos normativos y teórico-metodológicos del Centro Nacional de Información sobre la temática.

Quality is a worldwide requirement in the education area, and at the same time it is a fundamental indicator for educational institutions which are subjected to provide a service of excellence. For this reason, evaluating the quality management of medical libraries in Villa Clara is a necessity, in order to contribute to the improvement of their functioning and to achieve a higher level of satisfaction of their users' information needs. The evaluation model for Cuban university libraries and the normative, theoretical and methodological documents of the National Information Center of Medical Sciences regarding this subject were taken as theoretical references.

Quality improvement initiative to improve communication domains of patient satisfaction in a regional community hospital with Six Sigma methodology.

BACKGROUND: Communication gaps, whether incomplete or fragmented communication, have been the cause of many disasters in human civilisation. Coordination of healthcare is directly related to proper communication and handoffs among multidisciplinary teams throughout multiple shifts during a patient's hospitalisation. LOCAL PROBLEM: Patient surveys and direct patient feedback at Mayo Clinic Health System in Mankato, Minnesota, indicated that patient communication with physicians and nurses had declined in 2017 and 2018. Viewing this as an opportunity for improvement, our leadership initiated several changes to increase physician and nurse communication with patients, which resulted in no notable improvements. METHODS: A systematic quality improvement approach was implemented by using Six Sigma methodology. Stakeholders from multidisciplinary teams were assembled as the project team. The five steps of Six Sigma methodology (Define, Measure, Analyse, Improve and Control) were followed to create a quality improvement intervention. INTERVENTION: We developed a standardised and easy-to-use bedside team rounding tool to improve patient communication with physicians and nurses. RESULTS: Postintervention patient satisfaction top-box scores exceeded target improvements for both physician (from 78.5% to 82.0%, p<0.01) and nurse (from 80.5% to 83.1%, p=0.04) communication domains. Physicians had a 33-point increase in percentile rank (from 41st to 74th percentile rank), and nurses had a 25-point increase in percentile rank (from 59th to 84th percentile rank). This increase in communication ranked our institution at the top of national benchmark organisations. CONCLUSIONS: Overwhelmingly positive patient feedback was achieved, and postintervention employee satisfaction was primarily positive when compared with preintervention satisfaction.

Sigma metric used to evaluate the performance of haematology analysers: choosing an internal reference analyser for the laboratory.

INTRODUCTION: The sigma metric offers a quantitative framework for evaluating process performance in clinical laboratories. This study aimed to evaluate the analytical performance of automated analysers in haematology laboratories, using the sigma metric to choose the best analyser as an internal reference analyser. MATERIALS AND METHODS: internal quality control (IQC) data were collected for 6 months from SNCS, and the sigma value was calculated for 9 haematology analysers in the laboratory. RESULTS: For the normal control level, a satisfactory mean sigma value ≥3 was observed for all of the studied parameters of all automated analysers. For the low control level, platelet (PLT) count by Instrument (Inst.) G performed poorly, with a mean sigma value <3. Inst. H, with all parameters' sigma values >4, performed best and was chosen as the internal reference analyser. CONCLUSION: The sigma metric can be used as a guide to choose the QC strategy and plan QC frequency. It can facilitate the comparison of the same assay performed by multiple systems.

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.

Effect of total quality management intervention on nurse commitment and nurse performance: A quasi-experimental study.

BACKGROUND: The purpose of this study is to design, implement, and evaluate the impact of a total quality management intervention on job performance and commitment among Jordanian nurses working in government hospitals. METHODS: A quasi-experimental multiple time series was conducted starting in September 2017 and ending in June 2018. 140 nurses were sampled using the proportionate stratified random sampling technique; 132 were completed the study 67 the intervention group, while 65 in the control group. RESULTS: There were no significant differences in nurses' job performance or commitment between the 2 groups (control and intervention). A repeated measure MANOVA test for both groups revealed that the interaction between group and time was statistically significant (F (4, 127) = 144.841; P = .001; Wilk's Λ = 0.180; η2 = .820), indicating that groups had a significantly different pattern of job performance and commitment over time. A repeated test The MANCOVA test for both groups across time revealed significant differences in nurses' job performance and nurses' commitment at a less than 0.05 significance level (F (2127) = 320.724; P = .001; Wilk's Λ = 0.165; η2 = 0.835), and the overall effect of time was significant for all dependent variables (F (4125) = 36.879; P = .001; Wilk's Λ = 0.459; η2 = 0.541). CONCLUSION: The educational intervention was effective in improving nursing job performance among the study sample. The improved commitment of respondents in the intervention group was attributed to the improvement in job performance.

[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.

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.

Condition optimization of eco-friendly RP-HPLC and MCR methods via Box-Behnken design and six sigma approach for detecting antibiotic residues.

A precise, Eco-friendly, and highly sensitive RP-HPLC method was employed using quality-by-design principles to concurrently identify cephalexin and cefixime residues in the manufacturing machines using a hypersil BDS C18 column (250 × 4.6 mm, 5 µm) at wavelength 254 nm. The Box-Behnken design was applied to obtain the best chromatographic conditions with the fewest possible trials. Three independent factors viz organic composition, flow rate, and pH were used to assess their effects on the responses' resolution and retention time. Overlay plot and desirability functions were implemented to predict responses of the high resolution and relatively short retention time using a mobile phase composed of acidic water: acetonitrile (85:15, v/v) at pH 4.5 adjusted by phosphoric acid with a flow rate of 2.0 mL/min. The spectral overlapping of the drugs was successfully resolved by the mean centering ratio (MCR) spectra approach at 261 nm and 298 nm for cephalexin and cefixime, respectively. Good linearity results were obtained for the suggested HPLC and MCR methods over the concentration range of (0.05-10 ppm) and (5-30 ppm) with a detection limit of 0.003, 0.004, 0.26, and 0.23 ppm, and quantitation limits of 0.008, 0.013, 0.79, and 0.68 ppm for cephalexin and cefixime, respectively, with a correlation coefficient of ≥ 0.9998 and good swab recovery results of 99-99.5%. A process capability index was accomplished for chemical and micro results, illustrating that both are extremely capable. The suggested method was effectively validated using ICH recommendations.

Six Sigma can significantly reduce costs of poor quality of the surgical instruments sterilization process and improve surgeon and operating room personnel satisfaction.

Operating room (OR) management is a complex multidimensional activity combining clinical and managerial aspects. This longitudinal observational study aimed to assess the impact of Six-Sigma methodology to optimize surgical instrument sterilization processes. The project was conducted at the operating theatre of our tertiary regional hospital during the period from July 2021 to December 2022. The project was based on the surgical instrument supply chain analysis. We applied the Six Sigma lean methodology by conducting workshops and practical exercises and by improving the surgical instrument process chain, as well as checking stakeholders' satisfaction. The primary outcome was the analysis of Sigma improvement. Through this supply chain passed 314,552 instruments in 2022 and 22 OR processes were regularly assessed. The initial Sigma value was 4.79 ± 1.02σ, and the final one was 5.04 ± 0.85σ (SMD 0.60, 95%CI 0.16-1.04, p = 0.010). The observed improvement was estimated in approximately $19,729 of cost savings. Regarding personnel satisfaction, 150 questionnaires were answered, and the overall score improved from 6.6 ± 2.2 pts to 7.0 ± 1.9 pts (p = 0.013). In our experience the application of the Lean Six Sigma methodology to the process of handling the surgical instruments from/to the OR was cost-effective, significantly decreased the costs of poor quality and increased internal stakeholder satisfaction.

A importância do Sistema Único de Saúde para o aprimoramento da Saúde Coletiva / The importance of the Unified Health System for improving Public Health

O artigo pretende resgatar a relevância do Sistema Único de Saúde (SUS) como Política Pública que alicerça a promoção e prevenção da saúde coletiva. A metodologia utilizada foi a revisão integrativa da literatura a partir da busca de artigos em Lilacs, MedLine e Scielo, utilizando os descritores: SUS, Saúde Coletiva e Pública e História da Saúde. Procedeu-se ao cruzamento dos descritores para elucidar as implicações de ações de promoção e prevenção em saúde para o aprimoramento da saúde coletiva.a utilização de escalas como a PUSH na avaliação dos cuidados prestados é essencial para nortear o atendimento.(AU)

This article aims to rescue the relevance of the Unified Health System (SUS) as a Public Policy that underpins the promotion and prevention of collective health. The methodology used was an integrative literature review from the search for articles in Lilacs, MedLine and Scielo databases, using the descriptors: SUS, Collective and Public Health, History of Health. The descriptors were crossed to elucidate the implications of actions with promotion and prevention for the improvement of collective health(AU)

Este artículo tiene como objetivo destacar la importancia del Sistema Único de Salud (SUS) como política pública que sustenta la promoción y prevención de la salud colectiva. La metodología utilizada fue una revisión bibliográfica integradora basada en la búsqueda de artículos en Lilacs, MedLine y Scielo, utilizando los descriptores: SUS, Salud Colectiva y Pública e Historia de la Salud. Los descriptores fueron cruzados para dilucidar las implicaciones de las acciones de promoción y prevención de la salud en la mejora de la salud colectiva.(AU)

Lean Six Sigma methodology to improve the discharge process in a Brazilian intensive care unit.

OBJECTIVES: to describe the Lean Six Sigma implementation process to improve the discharge process in a Brazilian health institution's ICU. METHODS: prospective study following the Define-Measure-Analyse-Improve-Control project development method. This method consists of five phases, namely: project definition, measurement of the starting point and data collection, analysis of results, improvement in processes, and statistical control. RESULTS: applying Lean Six Sigma methodology following the Define-Measure-Analyse-Improve-Control in the discharge process from the intensive care unit to the inpatient unit was effective in improving processes. This improvement represented a reduction in the mean patient transfer time to the inpatient unit from 189 minutes to 75 minutes, representing a 61% improvement in discharge time. CONCLUSIONS: this article demonstrates the effectiveness of applying Lean Six Sigma methodology to improve the discharge flow in a critical unit, resulting in time and waste reduction.

Padrão documental dos cuidados de enfermagem à pessoa em situação paliativa / Documentary standard of nursing care for people in a palliative situation

O aumento da esperança média de vida e o consequente envelhecimento populacional, aliados ao aumento da prevalência de doenças crónicas, progressivas e limitantes tem-se traduzido em mudanças importantes no contexto das políticas de saúde, objetivando-se um fim de vida digno e com qualidade. Neste contexto, os Cuidados Paliativos representam a proposta terapêutica mais adequada, uma vez que procuram melhorar a qualidade de vida dos doentes, das suas famílias e cuidadores pela prevenção e alívio do sofrimento, através da identificação precoce, diagnóstico e tratamento adequado da dor e de outros problemas, sejam estes físicos, psicológicos, sociais ou espirituais. No âmbito do I Curso de Mestrado em Enfermagem à Pessoa em Situação Paliativa da Escola Superior de Saúde do Instituto Politécnico de Viana do Castelo, realizou-se o estágio de natureza profissional no Serviço Integrado de Cuidados Paliativos da Unidade Local de Saúde do Alto Minho, no período compreendido entre o dia 03 de março a 31 de agosto de 2022. Ao longo do estágio foram desenvolvidas atividades em diversos domínios, nomeadamente na prestação de cuidados à pessoa em situação paliativa; no domínio da gestão dos cuidados, dos recursos materiais e humanos em estreita colaboração com a enfermeira gestora do serviço; no planeamento de atividades de formação como meio de dar resposta aos projetos do serviço; na promoção da melhoria da qualidade dos cuidados colaborando no projeto de candidatura à acreditação da idoneidade formativa do contexto da prática clínica. Foi desenvolvido, também, um trabalho de investigação que respondeu à necessidade de uma sistematização dos registos de enfermagem do referido serviço recorrendo a linguagem classificada, através da construção de um Padrão Documental dos Cuidados de Enfermagem à Pessoa em Situação Paliativa. Optou-se por um estudo metodológico, com recurso à Técnica de Delphi. Através da pesquisa bibliográfica e da consulta dos profissionais de enfermagem do serviço, foram identificados os fenómenos de enfermagem mais relevantes para a prática de cuidados de qualidade à pessoa em situação paliativa. Posteriormente, foram identificados todos os diagnósticos e intervenções associados a esses mesmos fenómenos passíveis de serem integrados no SClínico através da parametrização nacional de diagnósticos/intervenções de enfermagem. O painel de peritos validou uma versão de consenso composta por 176 itens (diagnósticos e intervenções de enfermagem). Este Padrão Documental permitirá implementar no serviço registos uniformizados, possibilitando a monitorização de indicadores e assegurando dois requisitos fundamentais no âmbito da candidatura à acreditação da idoneidade formativa do contexto da prática clínica pela Ordem dos Enfermeiros: um documento orientador dos registos clínicos de enfermagem de acordo com a linguagem classificada, bem como um Sistema de Informação em Enfermagem mapeado para a referida linguagem. Com a realização do estágio foi possível desenvolver competências especializadas na área da enfermagem à pessoa em situação paliativa, através da prestação de cuidados sob orientação dos enfermeiros especialistas do serviço, da partilha de experiências, da reflexão, e da pesquisa bibliográfica baseada em evidência científica. Estas estratégias revelaram-se fundamentais como forma de suprimir as questões que foram surgindo no decorrer deste percurso. Adquiriram-se competências técnicas, científicas e relacionais alicerçadas numa abordagem estruturada dos cuidados nos princípios da compaixão, humildade e honestidade. Compreendeu-se, também, a extrema relevância da investigação, que deve ser contínua e acompanhar a evolução e as necessidades dos Cuidados Paliativos, na produção de conhecimento e na prática de cuidados de qualidade.

The increase in average life expectancy and the consequent aging of the population, with the increase in the prevalence of chronic, progressive and limiting diseases, has resulted into important changes in the context of health policies, aiming for a dignified and quality end of life. In this context, Palliative Care represents the most appropriate therapeutic proposal, as it seeks to improve patient's quality of life as well as their families and caregivers by preventing and relieving suffering, through early identification, diagnosis, and appropriate treatment of pain and other problems, whether physical, psychological, social or spiritual. As part of the first Master´s Course in Nursing for People in Palliative Situations at the Escola Superior de Saúde do Instituto Politécnico de Viana do Castelo, a professional internship was carried out at the care unit Serviço Integrado de Cuidados Paliativos of Unidade Local de Saúde do Alto Minho, from March 03 to August 31, 2022. Throughout this internship, activities were carried out in several areas, namely in the provision of care to the person in a palliative situation and family; in the domain of care management, material and human resources in close collaboration with the head nurse of the care unit; in planning training activities as a mean of responding to service projects; in the promotion of the improvement of the quality of care by collaborating on the application project "acreditação da idoneidade formativa do contexto da prática clínica". A research work was also carried out, focused on a need of the care unit for a systematization of the nursing records of the care unit using classified language, through the construction of a Documentary Pattern of Nursing Care for People in Palliative Situations. We opted for a methodological study, using the Delphi technique. Through bibliographical research and consultation with nursing professionals from the service, the most relevant nursing phenomena for the practice of quality care for people in palliative situations were identified. Subsequently, all diagnoses and interventions associated with these same phenomena were identified, which could be integrated into SClínico through the national parameterization of nursing diagnoses/interventions. A panel of experts validated a consensus version consisting of 176 items (nursing diagnoses and interventions). This Documentary Pattern will allow the implementation of standardized records in the service, enabling the monitoring of indicators and ensuring two fundamental requirements in the scope of the application for the accreditation of the formative suitability of the clinical practice context: a guiding document for clinical nursing records in accordance with classified language, as well as a Nursing Information System mapped to that language. This professional internship enabled to develop specialized skills in the area of nursing for people in palliative situations, through the provision of care under the guidance of the specialist nurses of the care unit, sharing experiences, reflection, and bibliographic research based on scientific evidence. These strategies proved to be fundamental as a way of suppressing the questions that arose during this journey. Technical, scientific and relational skills were acquired based on a structured approach to care based on the principles of compassion, humility and honesty. The extreme relevance of research was also understood, which must be continuous and accompany the evolution and needs of Palliative Care, in the production of knowledge and in the practice of quality care.

Training Healthcare Professionals to Mitigate the Climate Challenge - Development of a Lean Six Sigma E-Learning.

This paper presents the preliminary findings of developing and evaluating a Lean Six Sigma (LSS) e-learning aimed at empowering healthcare professionals in different roles to make healthcare more sustainable. The e-learning was developed with experienced trainers and LSS experts by combining traditional LSS and environmental practices. Participants found the training engaging and confirmed they felt motivated and prepared to start applying the acquired skills and knowledge. We are now following the 39 participants to further investigate the effectiveness of LSS for mitigating the climate challenge in healthcare.

A "High-Reliability Organization" Approach to Improve Trauma Imaging Performance.

PURPOSE: CT is the gold standard for triaging critically ill patients, including in trauma, and its use has increased over time. CT turnaround times (TATs) are frequently targeted for improvement. As opposed to linear reductionist processes such as Lean and Six Sigma, a high-reliability organization (HRO) approach focuses on culture and teams to enable rapid problem solving. The authors evaluated the HRO model to rapidly generate, trial, select, and implement improvement interventions to improve trauma patient CT performance. METHODS: All trauma patients presenting to a single institution's emergency department during a 5-month period were included. Project periods included 2-month preintervention, 1-month wash-in, and 2-month postintervention. Each initial trauma CT encounter during the wash-in and postintervention periods created job briefs in which the radiologist ensured that all involved had the pertinent clinical information and agreed on the imaging needed, thereby creating a shared mental model as well as an opportunity to raise concerns and provide ideas for improvement. RESULTS: A total of 447 patients were included: 145 preintervention, 68 wash-in, and 234 postintervention. The seven selected interventions were trauma text alert; scripted CT technologist-radiologist communication; modification of CT acquisition, processing, sending, and interpretation; and trauma mobile phones. The seven selected interventions reduced trauma patient CT median TATs by 60% (78 vs 31 min, P < .001), demonstrating the effectiveness of an HRO approach to improvement. CONCLUSIONS: An HRO-based approach was rapid in generating, trialing, selecting, and implementing improvement interventions, and the interventions were effective at substantially decreasing trauma patient CT TATs.

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.

Chromatographic Techniques for Assessment of Bisoprolol Fumarate and Perindopril Arginine in Solid Formulations under Various Stress Conditions and Application to Six Sigma, Content Uniformity, and Comparative Dissolution Approaches.

BACKGROUND: Antihypertensives bisoprolol fumarate (BIS) and perindopril arginine (PER) were simultaneously determined in their pure, bulk, and combined tablet dosage form. OBJECTIVE: This study develops a novel, reproducible, and accurate Reversed phase high-performance liquid chromatography (RP-HPLC) and Reversed phase ultra-performance liquid chromatography (RP-UPLC) with photodiode array detection techniques, which were then applied to in vitro dissolution studies. METHODS: The first RP-HPLC method relied on isocratic elution using a mobile phase of methanol-0.05 M phosphate buffer pH 2.6 (1 + 1, by volume), and separation was performed using a Thermo Hypersil C8 column (150 mm × 4.6 mm, 5 µm). Ion-pair UPLC was the second method. An acceptable resolution was achieved using an RP-C18 chromatographic column, Agilent Eclipse (100 × 2.1 mm, 1.7 µm), with a mobile phase containing 0.005 M sodium 1-heptane sulfonate-triethylamine (64 + 1 + 35, by volume), adjusted with phosphoric acid to a pH of 2.0. RP-HPLC used a 1.0 mL/min flow rate, while UPLC used 0.5 mL/min, and the two methods used detection at 210 nm. RESULTS: Calibration curves of BIS and PER were linear for RP-HPLC and RP-UPLC methods at 0.5-15 and 0.5-40 µg/mL, respectively. BIS and PER had RP-UPLC LODs of 0.22 and 0.10 µg/mL, respectively, and LOQs of 0.68 and 0.31 µg/mL, respectively. As a result, the approach has been effectively applied to in vitro dissolution testing for drugs in generic and reference products, showing that the two products are comparable. The Six Sigma approach was implemented to compare the recommended and United States Pharmacopeia (USP) procedures, which both exhibited process capability index (Cpk) >1.33. A content uniformity test demonstrated that the drugs in their dosage form met the acceptance limit (85-115%). The degradation products were reliably distinguished from pure drugs for a range of retention times. CONCLUSION: In their commercial drug product, the proposed method could be used in QC laboratories for concurrent testing, content uniformity, and in vitro dissolution investigations of BIS and PER. The methods were successfully validated per International Council for Harmonisation (ICH) guidelines. HIGHLIGHTS: This study is innovative since it is the first to establish and validate specific and reproducible UPLC and HPLC methods for the concurrent quantitation of the studied drugs in their binary mixture and application to lean Six Sigma, content uniformity, and comparative dissolution approaches.