A Delayed Presentation of Bilateral Adrenal Hemorrhage Secondary to COVID-19.

Background/Objective: Bilateral adrenal hemorrhage is a rare cause of adrenal insufficiency. Cases have been reported of acute adrenal crisis with bilateral adrenal hemorrhage during acute coronavirus disease of 2019 (COVID-19). Our objective was to report a delayed presentation of acute adrenal crisis with bilateral adrenal hemorrhage 2 months after COVID-19. Case Report: An 89-year-old man who was hospitalized for COVID-19 pneumonia 2 months prior presented with lethargy. He was disorientated and hypotensive to 70/50 mm Hg without improvement with intravenous fluids. According to his family, since his previous hospitalization for COVID-19, his mental status had continued to deteriorate, and he was no longer able to perform activities of daily living. A computed tomography scan of the abdomen revealed bilateral heterogeneous enlargement of the adrenal glands. Laboratory values were significant for an am cortisol level of 8.42 mcg/dL, a sodium level of 134 mEq/L, and a bicarbonate level of 17 mEq/L. He was treated intravenously with hydrocortisone 100 mg and showed rapid improvement. Discussion: It has been shown that COVID-19 disease may cause an increased risk of bleeding or thromboembolism. The exact frequency of bilateral adrenal hemorrhage secondary to COVID-19 is unknown. Although there are a handful of cases reported, there are none to our knowledge with a delayed presentation, as exhibited in our patient. Conclusion: The patient's presentation was consistent with acute adrenal crisis due to bilateral adrenal hemorrhage from prior COVID-19 disease. We aimed to highlight the importance of clinicians being aware of adrenal hemorrhage and adrenal insufficiency as a possible delayed consequence in patients with a history of COVID-19.

Lean Management Systems in Health Care: A Review of the Literature.

BACKGROUND AND OBJECTIVES: Many health care organizations now employ Lean tools to improve value in health care, yet reports of their effectiveness vary. This variation may be explained by the context in which Lean is implemented, whether as a tool or as a management system. This article reports on a structured literature review conducted to understand the evidence base for the impact of Lean Management System implementation in health care. METHODS: A search of PubMed, Scopus, Emerald, EMBASE, CINAHL, and Business Source Complete databases was conducted in November 2017 and repeated in July 2020 to assess the evidence for the impact of Lean Management Systems in health care from 2000 to July 2020. Articles were included if they (1) reported on a Lean Management System or (2) reported on Lean Management System components as described by Mann 1 (ie, leader standard work, visual controls, daily accountability process, and discipline). RESULTS: A total of 52 articles met the inclusion criteria. Although all articles described some combination of leader standard work, visual management, and daily accountability as part of their Lean Management System, only a handful described use of all 3 components together. Only one explicitly mentioned the fourth component, discipline, required to consistently apply the first 3. The majority reported on single-unit or department implementations and most described daily huddles at the unit level that included review of key performance indicators, identification of improvement opportunities, and problem solving. The role of the leader in a Lean Management System was described a coach and a mentor. Barriers to adoption such as insufficient training and increased workload for nurses were noted along with the importance of relevance to the local context for unit teams to find value in huddle boards and huddles. As yet, evidence of Lean Management System effectiveness in driving health care improvement is absent due to weak study designs and lack of statistical rigor. CONCLUSION: Well-designed research on Lean Management Systems in health care is lacking. Despite increasing adoption of Lean Management Systems over the past 10 years and anecdotal reports of its effectiveness, very few articles provide quantitative data. Those that do report unit-level implementation only, little use of a comprehensive package of Lean Management Systems elements, and weaker study designs and statistical methods. More rigorous study designs and robust statistical analysis are needed to evaluate effectiveness of Lean Management Systems in health care. This represents a rich area for future health care management research.

Sustaining Reliability on Accountability Measures at The Johns Hopkins Hospital.

BACKGROUND: In 2012 Johns Hopkins Medicine leaders challenged their health system to reliably deliver best practice care linked to nationally vetted core measures and achieve The Joint Commission Top Performer on Key Quality Measures ®program recognition and the Delmarva Foundation award. Thus, the Armstrong Institute for Patient Safety and Quality implemented an initiative to ensure that ≥96% of patients received care linked to measures. Nine low-performing process measures were targeted for improvement-eight Joint Commission accountability measures and one Delmarva Foundation core measure. In the initial evaluation at The Johns Hopkins Hospital, all accountability measures for the Top Performer program reached the required ≥95% performance, gaining them recognition by The Joint Commission in 2013. Efforts were made to sustain performance of accountability measures at The Johns Hopkins Hospital. METHODS: Improvements were sustained through 2014 using the following conceptual framework: declare and communicate goals, create an enabling infrastructure, engage clinicians and connect them in peer learning communities, report transparently, and create accountability systems. One part of the accountability system was for teams to create a sustainability plan, which they presented to senior leaders. To support sustained improvements, Armstrong Institute leaders added a project management office for all externally reported quality measures and concurrent reviewers to audit performance on care processes for certain measure sets. CONCLUSIONS: The Johns Hopkins Hospital sustained performance on all accountability measures, and now more than 96% of patients receive recommended care consistent with nationally vetted quality measures. The initiative methods enabled the transition of quality improvement from an isolated project to a way of leading an organization.

Using Innovative Methodologies From Technology and Manufacturing Companies to Reduce Heart Failure Readmissions.

Heart failure (HF) patients have high 30-day readmission rates with high costs and poor quality of life. This study investigated the impact of a framework blending Lean Sigma, design thinking, and Lean Startup on 30-day all-cause readmissions among HF patients. This was a prospective study in an academic hospital in Baltimore, Maryland. Thirty-day all-cause readmission was assessed using the hospital's electronic medical record. The baseline readmission rate for HF was 28.4% in 2010 with 690 discharges. The framework was developed and interventions implemented in the second half of 2011. The impact of the interventions was evaluated through 2012. The rate declined to 18.9% among 703 discharges (P < .01). There was no significant change for non-HF readmissions. This study concluded that methodologies from technology and manufacturing companies can reduce 30-day readmissions in HF, demonstrating the potential of this innovations framework to improve chronic disease care.

Clinical Communities at Johns Hopkins Medicine: An Emerging Approach to Quality Improvement.

BACKGROUND: Clinical communities are an emerging approach to quality improvement (QI) to which several large-scale projects have attributed some success. In 2011 the Armstrong Institute for Patient Safety and Quality established clinical communities as a core strategy to connect frontline providers from six different hospitals to improve quality of care, patient safety, and value across the health system. CLINICAL COMMUNITIES: Fourteen clinical communities that presented great opportunity for improvement were established. A community could focus on a clinical area, a patient population, a group, a process, a safety-related issue, or nearly any health care issue. The collaborative spirit of the communities embraced interdisciplinary membership and representation from each hospital in each community. Communities engaged in team-building activities and facilitated discussions, met monthly, and were encouraged to meet in person to develop relationships and build trust. After a community was established, patients and families were invited to join and share their perspectives and experiences. ENABLING STRUCTURES: The clinical community structure provided clinicians access to resources, such as technical experts and safety and QI researchers, that were not easily otherwise accessible or available. Communities convened clinicians from each hospital to consider safety problems and their resolution and share learning with workplace peers and local unit safety teams. CONCLUSION: The clinical communities engaged 195 clinicians from across the health system in QI projects and peer learning. Challenges included limited financial support and time for clinicians, timely access to data, limited resources from the health system, and not enough time with improvement experts.

The Armstrong Institute: An Academic Institute for Patient Safety and Quality Improvement, Research, Training, and Practice.

Academic medical centers (AMCs) could advance the science of health care delivery, improve patient safety and quality improvement, and enhance value, but many centers have fragmented efforts with little accountability. Johns Hopkins Medicine, the AMC under which the Johns Hopkins University School of Medicine and the Johns Hopkins Health System are organized, experienced similar challenges, with operational patient safety and quality leadership separate from safety and quality-related research efforts. To unite efforts and establish accountability, the Armstrong Institute for Patient Safety and Quality was created in 2011.The authors describe the development, purpose, governance, function, and challenges of the institute to help other AMCs replicate it and accelerate safety and quality improvement. The purpose is to partner with patients, their loved ones, and all interested parties to end preventable harm, continuously improve patient outcomes and experience, and eliminate waste in health care. A governance structure was created, with care mapped into seven categories, to oversee the quality and safety of all patients treated at a Johns Hopkins Medicine entity. The governance has a Patient Safety and Quality Board Committee that sets strategic goals, and the institute communicates these goals throughout the health system and supports personnel in meeting these goals. The institute is organized into 13 functional councils reflecting their behaviors and purpose. The institute works daily to build the capacity of clinicians trained in safety and quality through established programs, advance improvement science, and implement and evaluate interventions to improve the quality of care and safety of patients.

Creating a high-reliability health care system: improving performance on core processes of care at Johns Hopkins Medicine.

In this article, the authors describe an initiative that established an infrastructure to manage quality and safety efforts throughout a complex health care system and that improved performance on core measures for acute myocardial infarction, heart failure, pneumonia, surgical care, and children's asthma. The Johns Hopkins Medicine Board of Trustees created a governance structure to establish health care system-wide oversight and hospital accountability for quality and safety efforts throughout Johns Hopkins Medicine. The Armstrong Institute for Patient Safety and Quality was formed; institute leaders used a conceptual model nested in a fractal infrastructure to implement this initiative to improve performance at two academic medical centers and three community hospitals, starting in March 2012. The initiative aimed to achieve ≥ 96% compliance on seven inpatient process-of-care core measures and meet the requirements for the Delmarva Foundation and Joint Commission awards. The primary outcome measure was the percentage of patients at each hospital who received the recommended process of care. The authors compared health system and hospital performance before (2011) and after (2012, 2013) the initiative. The health system achieved ≥ 96% compliance on six of the seven targeted measures by 2013. Of the five hospitals, four received the Delmarva Foundation award and two received The Joint Commission award in 2013. The authors argue that, to improve quality and safety, health care systems should establish a system-wide governance structure and accountability process. They also should define and communicate goals and measures and build an infrastructure to support peer learning.

Demonstrating high reliability on accountability measures at the Johns Hopkins Hospital.

BACKGROUND: Patients continue to suffer preventable harm from the omission of evidence-based therapies. To remedy this, The Joint Commission developed core measures for therapies with strong evidence and, through the Top Performer on Key Quality Measures program, recognize hospitals that deliver those therapies to 95% of patients. The Johns Hopkins Medicine board of trustees committed to high reliability and to providing > or = 96% of patients with the recommended therapies. METHODS: The Armstrong Institute for Patient Safety and Quality coordinated the core measures initiative, which targeted nine process measures for the 96% performance goal: eight Joint Commission accountability measures and one Delmarva Foundation core measure. A conceptual model for this initiative included communicating goals, building capacity with Lean Sigma methods, transparently reporting performance and establishing an accountability plan, and developing a sustainability plan. Clinicians and quality improvement staff formed one team for each targeted process measure, and Armstrong Institute staff supported the teams work. The primary performance measure was the percentage of patients who received the recommended process of care, as defined by the specifications for each of The Joint Commission's accountability measures. RESULTS: The > or = 96% performance goal was achieved for 82% of the measures in 2011 and 95% of the measures in 2012. CONCLUSIONS: With support from leadership and a conceptual model to communicate goals, use robust improvement methods, and ensure accountability, The Johns Hopkins Hospital achieved high reliability for The Joint Commission accountability measures.

Successful implementation of a perioperative glycemic control protocol in cardiac surgery: barrier analysis and intervention using lean six sigma.

Although the evidence strongly supports perioperative glycemic control among cardiac surgical patients, there is scant literature to describe the practical application of such a protocol in the complex ICU environment. This paper describes the use of the Lean Six Sigma methodology to implement a perioperative insulin protocol in a cardiac surgical intensive care unit (CSICU) in a large academic hospital. A preintervention chart audit revealed that fewer than 10% of patients were admitted to the CSICU with glucose <200 mg/dL, prompting the initiation of the quality improvement project. Following protocol implementation, more than 90% of patients were admitted with a glucose <200 mg/dL. Key elements to success include barrier analysis and intervention, provider education, and broadening the project scope to address the intraoperative period.

Applying Lean Sigma solutions to mistake-proof the chemotherapy preparation process.

BACKGROUND: Errors related to high-alert medications, such as chemotherapeutic agents, have resulted in serious adverse events. A fast-paced application of Lean Sigma methodology was used to safeguard the chemotherapy preparation process against errors and increase compliance with United States Pharmacopeia 797 (USP 797) regulations. WORKSHOP STRUCTURE AND PROCESS: On Days 1 and 2 of a Lean Sigma workshop, frontline staff studied the chemotherapy preparation process. During Days 2 and 3, interventions were developed and implementation was started. FINDINGS AND INTERVENTIONS: The workshop participants were satisfied with the speed at which improvements were put to place using the structured workshop format. The multiple opportunities for error identified related to the chemotherapy preparation process, workspace layout, distractions, increased movement around ventilated hood areas, and variation in medication processing and labeling procedures. Mistake-proofing interventions were then introduced via workspace redesign, process redesign, and development of standard operating procedures for pharmacy staff. Interventions were easy to implement and sustainable. Reported medication errors reaching patients and requiring monitoring decreased, whereas the number of reported near misses increased, suggesting improvement in identifying errors before reaching the patients. DISCUSSION: Application of Lean Sigma solutions enabled the development of a series of relatively inexpensive and easy to implement mistake-proofing interventions that reduce the likelihood of chemotherapy preparation errors and increase compliance with USP 797 regulations. The findings and interventions are generalizable and can inform mistake-proofing interventions in all types of pharmacies.

No time to waste: decreasing patient wait times for chemotherapy administration using automated prioritization in an oncology pharmacy system.

OBJECTIVES: To implement an automated pharmacy dispensing prioritization system and to evaluate its effect on the timing of dispensing and administration of chemotherapy. STUDY DESIGN: An electronic chemotherapy dispensing system that prioritized orders for pharmacy processing based on anticipated patient arrival at the oncology outpatient unit was implemented, followed by an educational intervention for pharmacy staff. METHODS: A time-controlled study evaluating the effect of the electronic chemotherapy dispensing system on late, early, and "within target" dispensing and administration of chemotherapy was conducted. RESULTS: A total of 13,138 chemotherapies were prepared and released pending medical clearance based on laboratory results (hereafter referred to as pending counts) (8677 [66.0%]) or pending arrival of the patient (hereafter referred to as pending arrival) (4461 [34.0%]) from March 1, 2005, to March 2, 2006. Chemotherapy dispensing and administration times were retrospectively compared with chemotherapy appointment times after adjustment for late patient arrival. Dispensing times continuously decreased from a mean delay in dispensing of 12 minutes after the adjusted chemotherapy appointment time at baseline to dispensing a mean of 5 minutes ahead of the scheduled time by the end of the study. Chemotherapy treatments dispensed within target increased from 62.9% to 74.7% (pending arrival) and from 53.4% to 68.1% (pending counts), and those administered within target increased from 64.9% to 71.8% (pending arrival) and from 56.0% to 70.1% (pending counts). CONCLUSION: An automated intervention for synchronizing chemotherapy preparation with anticipated times for administration was associated with significant reduction in wait times.

Reduction of catheter-associated bloodstream infections in pediatric patients: experimentation and reality.

OBJECTIVE: Few data exist on successes at reducing pediatric catheter-associated bloodstream infections (CA-BSI). The objective was to eradicate CA-BSI with a multifaceted pediatric-relevant intervention proven effective in adult patients. DESIGN: Prospective cohort of pediatric intensive care (PICU) patients with historical controls. SETTING: Multidisciplinary PICU. PATIENTS/PARTICIPANTS: PICU patients with intervention targeting PICU providers. INTERVENTIONS: Multifaceted intervention involving preintervention staff surveys, provider educational program, creation of central catheter procedure cart, guideline-supported central catheter insertion checklist, nursing staff empowerment to stop procedures that breached guidelines, and real-time data feedback to PICU leadership. MEASUREMENTS AND MAIN RESULTS: We measured rate of CA-BSI per 1000 catheter days from August 2001 through September 2006. Reliable use of evidence-based best practices for insertion of central catheters in our PICU was associated with a statistically and clinically significant decrease in our CA-BSI rate for 24 months postintervention (p < .05). During a portion of this postintervention period, we experienced a dramatic increase in our CA-BSI rate that was ultimately found to be due to the introduction of a new positive displacement mechanical valve intravenous port in April 2004. After removal of this positive displacement mechanical valve, our CA-BSI rate dropped from 5.2 +/- 4.5 CA-BSI per 1000 central catheter days to a rate of 3.0 +/- 1.9 CA-BSI per 1000 central catheter days. Chart review of postintervention CA-BSI cases revealed that these patients acquired CA-BSI weeks after both PICU admission and after insertion of the most recent central catheter. CONCLUSIONS: Our data show that improving practices for insertion of central catheters leads to a reduction of CA-BSI among pediatric patients but not elimination of CA-BSI. More research is needed to identify best practices for maintenance of central catheters for children. In addition, our experience shows that even despite good interventions to control CA-BSI, institutions must remain vigilant to factors such as new technology with apparent advantages but short track records of use.

How will we know patients are safer? An organization-wide approach to measuring and improving safety.

OBJECTIVE: Our institution, like many, is struggling to develop measures that answer the question, How do we know we are safer? Our objectives are to present a framework to evaluate performance in patient safety and describe how we applied this model in intensive care units. DESIGN: We focus on measures of safety rather than broader measures of quality. The measures will allow health care organizations to evaluate whether they are safer now than in the past by answering the following questions: How often do we harm patients? How often do patients receive the appropriate interventions? How do we know we learned from defects? How well have we created a culture of safety? The first two measures are rate based, whereas the latter two are qualitative. To improve care within institutions, caregivers must be engaged, must participate in the selection and development of measures, and must receive feedback regarding their performance. The following attributes should be considered when evaluating potential safety measures: Measures must be important to the organization, must be valid (represent what they intend to measure), must be reliable (produce similar results when used repeatedly), must be feasible (affordable to collect data), must be usable for the people expected to employ the data to improve safety, and must have universal applicability within the entire institution. SETTING: Health care institutions. RESULTS: Health care currently lacks a robust safety score card. We developed four aggregate measures of patient safety and present how we applied them to intensive care units in an academic medical center. The same measures are being applied to nearly 200 intensive care units as part of ongoing collaborative projects. The measures include how often do we harm patients, how often do we do what we should (i.e., use evidence-based medicine), how do we know we learned from mistakes, and how well do we improve culture. Measures collected by different departments can then be aggregated to provide a hospital level safety score card. CONCLUSION: The science of measuring patient safety is immature. This article is a starting point for developing feasible and scientifically sound approaches to measure safety within an institution. Institutions will need to find a balance between measures that are scientifically sound, affordable, usable, and easily applied across the institution.