The term DMAIC, which stands for “define, measure, analyze, improve, and control,” represents a method for process analysis used in Lean Six Sigma. To understand DMAIC methodology, one must first know the history of Lean and Six Sigma. “Lean” production originates from the Toyota Production System introduced in Japan by engineer Taiichi Ohno in the 1950s through 1980s. Lean principles (aspects of which are shaped by Japanese culture and Japanese Zen Buddhism) are designed to permeate every aspect of an organization from company culture and philosophy down to leadership, technology, teamwork, and task standardization.[1] Ultimately, the goal of Lean is to improve efficiency of a process and deliver the best product by eliminating waste.[1] Six Sigma is a Western concept that originated from statistical modeling of manufacturing processes themselves. In the 1920s, Walter Shewhart created the basis for statistical process control with the concept that observed variation in a manufacturing process leads to deviation which results in an unideal product.[2] Furthermore, changing a manufacturing process without proper analysis can worsen variation and result in more defects. Shewhart went on to work with physicist Edwards Deming to develop the “Plan Do Study Act” (PDSA) cycle in the 1930s.[3] These concepts were applied by engineer Bill Smith in the 1980s to reduce process variation at Motorola and were coined, “Six Sigma.” [2] “Lean Six Sigma” combines the principles of both Lean and Six Sigma with the overarching goal to reduce both waste and variation within a system using data and continuous quality improvement. To reduce variation in a process, Six Sigma utilizes statistical analysis through a 5-step approach called the DMAIC method.Six Sigma and the DMAIC method originated in the manufacturing industry; however, by the late 1990s several healthcare organizations had adopted these concepts to improve patient safety and healthcare delivery.[4] Challenges exist when implementing DMAIC methodology into a dynamic multifaceted health system. Unlike the production line in a factory, a health system is not delivering a singular standardized product and patients are not the only consumers. Healthcare professionals may bristle at the notion of standardization, believing it will limit their autonomy to make decisions.[5] Gold-standards and medical recommendations may exist, but often with variation in strength of evidence; these are meant not as hard rules but rather as a guide in conjunction with clinical judgment. These qualities of patient care make removal of variation difficult; however, ample opportunities appropriate for standardization still exist. Lean Six Sigma concepts have been applied successfully to improve these various aspects of patient care. In a recent systematic review from 2020, Ninerola and colleagues identified 196 manuscripts outlining Six Sigma use in the healthcare sector.[6] Most of these originated from the United States and were published case studies. Multiple specialties and services have used these methods to standardize and improve one or more processes. For example, Six Sigma methodologies using DMAIC have been used to reduce wait times for radiology results, improve the safe administration of medications, and decrease unnecessary antibiotic use.[7–9]Figure 1 is adapted from recent publications discussing the use of DMAIC in healthcare and outlines the steps and process tools involved.[9,10] One advantage to DMAIC methodology compared to PDSA cycles (also known as the Deming or Shewhart cycle) is that a more robust preparation of measurement and analysis occurs before any change or improvements are proposed. Change is not proposed until step 4 of 5 (as opposed to step 2 of the PDSA cycle). Additionally, process control is required as a built-in final step, which may help impart lasting change regardless of whether the cycle is repeated.In the define phase, stakeholders must clearly define the project objective, scope, and if possible, the time frame. Stakeholders must agree on what the target of the project is, as well as its duration. This may include a process map or other analysis (Financial, Stakeholder, or Kano analysis), to develop an aims statement.Measurable data to serve as quality or safety indicators are identified. This may require conducting data collection to establish baseline metrics. Data extracted from aggregate databases should be analyzed for accuracy. Data should be able to be displayed visually for subsequent analysis. Box plots, pareto charts, control charts, or histograms may be used which will subsequently be used in further steps. An exemption from the institutional review board can usually be obtained for data being used for quality improvement.This step merges what is known about the process as well as the baseline data to identify and validate the causes of errors, deviation, delays, waste, or other etiologies of defects in the process. Analysis may include pareto diagrams, histograms, pie charts, Ishikawa (fishbone) diagrams, a 5-whys analysis, or other tools to explore cause and effect.In this phase, the team works to address the root cause and make changes to eliminate the issues leading to variability and waste in the process. Communication with team members and team involvement and commitment is parament. Stakeholders should be comfortable brainstorming and using clear and regular communication about potential solutions. Various stakeholders may disagree about who or what needs to change to reach the targeted goal. National benchmarking and discussion of established best practices may be needed. Keep in mind that interventions relying on human memory (education, pocket cards, policy changes, email reminders) may be appropriate, but will be weaker than those that are tied directly to process flow (hard stops in ordering, electronic alerts). The concept of Kaizen...

Invasive candidiasis is a common healthcare-associated infection with high mortality and is difficult to diagnose due to nonspecific symptoms and limitations of culture based diagnostic methods. T2Candida, based on T2 magnetic resonance technology, is FDA approved for the diagnosis of candidemia and can rapidly detect the five most commonly isolated Candida sp. in approximately 5 h directly from whole blood. We discuss the preclinical and clinical studies of T2Candida for the diagnosis of candidemia and review the current literature on its use in deep-seated candidiasis, its role in patient management and prognosis, clinical utility in unique populations and non-blood specimens, and as an antifungal stewardship tool. Lastly, we summarize the strengths and limitations of this promising nonculture-based diagnostic test.

Introduction Changes in medical education and health care delivery have limited the ability of fourth-year medical students to perform the role of an intern prior to graduating from medical school. To address this issue, many schools have instituted residency preparation courses (sometimes referred to as boot camps) particularly for students entering surgical fields. Courses for students entering nonprocedural fields are less common and most assess increases in selfreported confidence without providing objective evidence of a gain in knowledge or skills improvement. Materials and Methods We used a Plan, Do, Study, Act (PDSA) model to develop and pilot cycle 1 of a nonprocedural internship preparation elective in 2019. Feedback was used to refine the course and map sessions to core competencies outlined by the Accreditation Council of Graduate Medical Education (ACGME) for PDSA cycle 2. The curriculum was adapted for remote synchronous delivery due to the coronavirus pandemic in spring 2020 using a combination of didactic lectures containing embedded polls and case-based role play responses using a chat box. Students completed anonymous surveys assessing self-perceived levels of confidence, as well as an objective comprehensive assessment after course completion. Results A total of 89 students participated in the course. Pre-session confidence was lowest for transfusion medicine, handling pages from nursing while on call, and knowledge of the role of a chief resident. A statistically significant increase in median scores for self-reported knowledge or confidence was seen in all sessions. The percentage of students reporting that they were either confident or extremely confident also increased significantly after each session (p<0.001 for all). All sessions analyzed were rated as useful or extremely useful by more than half of the students, and 94% of the students scored 70% or higher on the comprehensive course assessment. Conclusions n online virtual synchronous boot camp increased students' confidence in handling common topics encountered during residency and demonstrated an appropriate gain in knowledge using a comprehensive assessment. We were able to adapt our curriculum to a remote model and will likely keep several sessions in an online format in the future.

Clostridioides difficile infection (CDI) remains a significant contributor to healthcare costs and morbidity due to high rates of recurrence. Currently, available antibiotic treatment strategies further disrupt the fecal microbiome and do not address the alterations in commensal flora (dysbiosis) that set the stage for CDI. Advances in microbiome-based research have resulted in the development of new agents, classified as live biotherapeutic products (LBPs), for preventing recurrent CDI (rCDI) by restoring eubiosis. Prior to the LBPs, fecal microbiota transplantation (FMT) was available for this purpose; however, lack of large-scale availability and safety concerns have remained barriers to its widespread use. The LBPs are an exciting development, but questions remain. Some are derived directly from human stool while other developmental products contain a defined microbial consortium manufactured ex vivo, and they may be composed of either living bacteria or their spores, making it difficult to compare members of this heterogenous drug class to one another. None have been studied head-to head or against FMT in preventing rCDI. As a class, they have considerable variability in their biologic composition, biopharmaceutic science, route of administration, stages of development, and clinical trial data. This review will start by explaining the role of dysbiosis in CDI, then give the details of the biopharmaceutical components for the LBPs which are approved or in development including how they differ from FMT and from one another. We then discuss the clinical trials of the LBPs currently approved for rCDI and end with the future clinical directions of LBPs beyond C. difficile.

The COVID-19 pandemic caused >6 million deaths worldwide, often from respiratory failure. Complications frequently occurred in hospitalized patients, particularly in the intensive care unit. Among these, fungal infections were a cause of high morbidity and mortality. Invasive aspergillosis, candidiasis and mucormycosis were the most serious of these infections. Risk factors included alterations in immune defense mechanisms by COVID-19 itself, as well as immunosuppression due to various therapies utilized in severely ill patients. Diagnosis was often challenging due to lack of sensitivity of current testing. Outcomes were generally poor, due to significant co-morbidities and delayed diagnosis, with mortality rates >50% in some studies. High index of clinical suspicion is needed to facilitate early diagnosis and initiation of appropriate antifungal therapy.

The Infectious Diseases Society of America (IDSA) recommends a minimum of 5 days of antibiotic therapy in stable patients who have community-acquired pneumonia (CAP). However, excessive duration of therapy (DOT) is common. Define, measure, analyze, improve, and control (DMAIC) is a Lean Six Sigma methodology used in quality improvement efforts, including infection control; however, the utility of this approach for antimicrobial stewardship initiatives is unknown. To determine the impact of a prospective physician-driven stewardship intervention on excess antibiotic DOT and clinical outcomes of patients hospitalized with CAP. Our specific aim was to reduce excess DOT and to determine why some providers treat beyond the IDSA minimum DOT. A single-center, quasi-experimental quality improvement study evaluating rates of excess antimicrobial DOT before and after implementing a DMAIC-based antimicrobial stewardship intervention that included education, prospective audit, and feedback from a physician peer, and daily tracking of excess DOT on a Kaizen board. The baseline period included retrospective CAP cases that occurred between October 2018 and February 2019 (control group). The intervention period included CAP cases between October 2019 and February 2020 (intervention group). A total of 123 CAP patients were included (57 control and 66 intervention). Median antibiotic DOT per patient decreased (8 versus 5 days; p < 0.001), and the proportion of patients treated for the IDSA minimum increased (5.3% versus 56%; p < 0.001) after the intervention. No differences in mortality, readmission, length of stay, or incidence of Clostridioides difficile infection were observed between groups. Almost half of the caregivers surveyed were aware that as few as 5 days of antibiotic treatment could be appropriate. A physician-driven antimicrobial quality improvement initiative designed using DMAIC methodology led to reduced DOT and increased compliance with the IDSA treatment guidelines for hospitalized patients with CAP reduced without negatively affecting clinical outcomes.