Search

A multidisciplinary team developed a policy-based approach that provides guidance for using peer review protected information for safety research while maintaining peer review privilege. The approach includes project approval by an ad hoc review committee, signed confidentiality agreements by investigators and study staff, early removal of case identification numbers, standards for maintaining data security, and publication of aggregate data without data set sharing. By describing this procedure and embedding into an institutional policy on Data for Performance Improvement, the team encourages other institutions to develop similar policies consistent with their state regulations.

Patient tracers and leadership WalkRounds proactively identify quality and safety issues. However, these programs have been inconsistent in application, results, and sustainability. The goal was to identify a more consistent and efficient approach to survey health care facilities. The authors developed a Peer-to-Peer Interdisciplinary Patient Tracer program to assess compliance with National Patient Safety Goals and to proactively identify areas of inpatient, ambulatory, and procedural risk. The program has been operational for more than 5 years, with continued expansion annually. In all, 96% of frontline leadership reported satisfaction; 100% reported that they would recommend the program to others (Kirkpatrick level 1 results). Mean absolute change in performance scores from 2014 to 2018 was 15%. All survey findings triggered the development of an improvement project. This novel integrated program advanced institutional improvement by strengthening internal peer-to-peer surveillance, engaging leadership, and creating an accountability structure for internal improvement efforts.

Supplemental digital content is available in the text., Background Twenty-five years after the seminal work of the Harvard Medical Practice Study, the numbers and specific types of health care measures of harm have evolved and expanded. Using the World Café method to derive expert consensus, we sought to generate a contemporary list of triggers and adverse event measures that could be used for chart review to determine the current incidence of inpatient and outpatient adverse events. Methods We held a modified World Café event in March 2018, during which content experts were divided into 10 tables by clinical domain. After a focused discussion of a prepopulated list of literature-based triggers and measures relevant to that domain, they were asked to rate each measure on clinical importance and suitability for chart review and electronic extraction (very low, low, medium, high, very high). Results Seventy-one experts from 9 diverse institutions attended (primary acceptance rate, 72%). Of 525 total triggers and measures, 67% of 391 measures and 46% of 134 triggers were deemed to have high or very high clinical importance. For those triggers and measures with high or very high clinical importance, 218 overall were deemed to be highly amenable to chart review and 198 overall were deemed to be suitable for electronic surveillance. Conclusions The World Café method effectively prioritized measures/triggers of high clinical importance including those that can be used in chart review, which is considered the gold standard. A future goal is to validate these measures using electronic surveillance mechanisms to decrease the need for chart review.

OBJECTIVES: Documentation of allergies in a coded, non-free-text format in the electronic health record (EHR) triggers clinical decision support to prevent adverse events. Health system-wide patient safety initiatives to improve EHR allergy documentation by specifically decreasing free-text allergy entries have not been reported. The goal of this initiative was to systematically reduce free-text allergen entries in the EHR allergy module. METHODS: We assessed free-text allergy entries in a commercial EHR used at a multi-hospital integrated healthcare system in the greater Boston area. Using both manual and automated methods, a multidisciplinary consensus group prioritized high risk and frequently used free-text allergens for conversion to coded entries, added new allergen entries, and deleted duplicate allergen entries. Environmental allergies were moved to the patient problem list. RESULTS: We identified 242,330 free-text entries, which included a variety of environmental allergies (42%), food allergens (18%), contrast media allergies (13%), “no known allergy” (12%), drug allergies (2%), and “no contrast allergy” (2%). The majority of free-text entries were entered by medical assistants in ambulatory settings (34%) and registered nurses in peri-operative settings (20%). We remediated a total of 52,206 free-text entries with automated methods, and 79,578 free-text entries with manual methods. CONCLUSION: Through this multidisciplinary intervention, we identified and remediated 131,784 free-text entries in our EHR to improve clinical decision support and patient safety. Additional strategies are required to completely eliminate free-text allergy entry, and establish systematic, consistent and safe guidelines for documenting allergies.

BackgroundMedical malpractice data can be used to improve patient safety.ObjectiveTo describe the types of harm events involving nurses that lead to malpractice claims and to compare claims among intensive care units (ICUs), emergency departments, and operating rooms.MethodsMalpractice claims closed between 2007 and 2016 were extracted from a national database. Claims with a nurse as the primary provider were identified and then compared by location of the harm event: ICU, emergency department, or operating room. Multivariable regression was used to determine predictors of claims payment.ResultsOf 54 699 claims, 314 involved ICU nurses as the primary provider. The majority (59%) of claims involving ICU nurses resulted in death or permanent injury. The most common allegation of claims involving ICU nurses was failure to monitor (47%), which was higher than among claims against nurses in the emergency department (9%) or the operating room (4%) (P < .001). The most common diagnosis in claims involving ICU nurses was decubitus ulcers (26%). Despite equivalent numbers of defendants per claim, the median indemnity for paid claims involving ICU nurses was higher ($125 000) than that paid for claims originating in the emergency department ($56 799) or operating room ($43 910) (P < .001). In multivariable regression, 2 variables increased the risk of claim payment: ICU location (odds ratio, 1.79 [95% CI, 1.29-2.48]) and permanent injury (odds ratio, 1.50 [95% CI, 1.07-2.09]).ConclusionsMalpractice claims involving ICU nurses were distinct from claims in comparably fast-paced settings. Focusing harm-prevention efforts in the ICU on skin integrity and monitoring of patients would most likely mitigate many highly severe harms involving ICU nurses, which would benefit both patients and nurses.

The objective of this study is to review and compare patient safety dashboards used by hospitals and identify similarities and differences in their design, format, and scope. We reviewed design features of electronic copies of patient safety dashboards from a representative sample of 10 hospitals. The results show great heterogeneity in the format, presentation, and scope of patient safety dashboards. Hospitals varied in their use of performance indicators (targets, trends, and benchmarks), style of color coding, and timeframe for the displayed metrics. The average number of metrics per dashboard display was 28, with a wide range from 7 to 84. Given the large variation in dashboard design, there is a need for future work to assess which approaches are associated with the best outcomes, and how specific elements contribute to usability, to help customize dashboards to meet the needs of different clinical, and operational stakeholders.

Background Medical malpractice data can be leveraged to understand specialty-specific risk. Methods Malpractice claims were examined from the Comparative Benchmarking System (2007-2016), a national database containing > 30% of claims data in the United States. Claims were identified with either internal medicine or pulmonary/critical care (PCC) physicians as the primary provider involved in the harm. Claim characteristics were compared according to specialty and care setting (inpatient vs outpatient), and multiple regression analysis was performed to predict claim payment. Results Claims involving PCC physicians differed from those involving internal medicine physicians in terms of harm severity, allegation, final diagnosis, procedure involvement, payment rate, and contributing factors. The majority of claims involving PCC physicians resulted from inpatient care (63%), of which only 26% occurred delivering intensive care. Eighty-one percent were from harm events that resulted in death/permanent injury. The most common diagnosis was laceration during a procedure for inpatient claims (6%) and lung cancer for outpatient claims (28%). Thirty-one percent of claims overall involved procedures. Although only 26% were paid, the median indemnity per paid claim of $285,769 ranked PCC as the twelfth highest of 69 specialties. The two variables associated with indemnity payment were outpatient care (OR, 1.70; 95% CI, 1.01-2.86) and temporary harm (OR, 0.36; 95% CI, 0.15-0.87). Conclusions Malpractice claims involving PCC physicians were distinct from claims involving internal medicine physicians. Although only one-quarter of claims was paid, the indemnity per claim was high among specialties. Specialty-specific prevention strategies must be developed to mitigate both patient harm and provider malpractice risk.

Background The practice of overlapping surgery impacts patients, providers, and policy-makers. While several studies have examined the relationship between overlapping surgery and clinical outcomes, a combined analysis of all available data has not been performed. We aimed to evaluate the impact of overlapping surgery on 30-day mortality, morbidity, and length of surgery. Methods A systematic literature review revealed all relevant studies examining outcomes of overlapping versus non-overlapping surgery as of March 2018. A pooled meta-analysis with stratification by study quality grade was performed, and heterogeneity and publication bias were assessed. Results A total of 14 sets of analyses met inclusion and exclusion criteria. Meta-analysis revealed no significant differences in 30-day mortality (OR = 0.84; p = 0.277) or overall morbidity (OR = 0.96; p = 0.632) between patients who underwent overlapping versus non-overlapping surgery. The standardized mean difference for length of surgery between the groups indicated a small statistically significant increase in length of surgery for the overlapping surgery group (SMD = 0.079, p Conclusion While further study is warranted, current literature suggests that overlapping surgery is not associated with increased risk of mortality or morbidity.

We aimed to study the contributing factors and costs of malpractice claims involving the surgical management of benign biliary disease given the emotional, physical, and financial toll of these claims on patients, providers, and the healthcare system.Cholecystectomy complications carry significant morbidity and rank among the leading sources of surgical malpractice claims.Using the CRICO Strategies' Comparative Benchmarking System database, representing approximately 30% of all paid and unpaid malpractice claims in the United States, 4081 closed claims filed against general surgeons from 1995 to 2015 were reviewed to isolate 745 cholecystectomy-related claims. A multivariable model was used to determine factors associated with claim outcome.The most common associated complications included bile duct injury (n = 397), bowel perforation (n = 96), and hemorrhage (n = 78). Bile duct injuries were recognized intraoperatively only 19% of the time and required biliary reconstruction surgery 77% of the time. The total cost for all claims over the study period was over $128 M and the median time from event to case close was over 3 years. 40% of claims resulted in patient payout; of these, most claims were settled out of court and the median cost per claim was $264,650. For the 60% of claims not resulting in patient payout, most cases were denied, dropped, or dismissed, yet still averaged over $15,000 per claim in legal and administrative fees. On multivariable analysis, bile duct injury, bowel perforation, and high clinical severity were associated with patient payout, while a resident or fellow being named in a claim was negatively associated with patient payout (P0.05).Cholecystectomy-related claims are costly and time-consuming. Strategies that reduce the risk and aid in recognition of cholecystectomy complications, as well as advance support of patients and families after poor outcomes, may improve clinical care and reduce claim burden.

BACKGROUND: Allergy safety requires understanding the operational processes that expose patients to their known allergens, including how and when such processes fail. OBJECTIVE: To improve health care safety for patients with allergies, we developed and assessed an allergy safety event classification schema to describe failures resulting in allergy-related safety events. METHODS: Using keyword searches followed by expert manual review of 299,031 voluntarily-filed safety event reports at 2 large academic medical centers, we identified and classified allergy-related safety events from 5 years of safety reports. We used driver diagrams to elucidate root causes for commonly observed allergy safety events in health care settings. RESULTS: From 299,031 safety reports, 1922 (0.6%) were extracted with keywords and 744 (0.2%) were manually confirmed as allergy-related safety events. Safety failures were due to incomplete/inaccurate electronic health record documentation (n = 375, 50.4%), human factors (n = 175, 23.5%), allergy alert limitation and/or malfunction (n = 127, 17.1%), data exchange and interoperability failures (n = 92, 12.4%), and electronic health record system default options (n = 30, 4.0%). Safety failures resulted in known allergen exposures to drugs (n = 537), including heparin (n = 27) and topical anesthetics such as lidocaine (n = 8); latex (n = 114); food allergens (n = 73); and adhesive (n = 23). CONCLUSIONS: We identified 744 allergy-related safety events to inform a novel safety failure classification schema as an important step toward a safer health care environment for patients with allergies. Improved systems are required to address safety issues with certain food and drug allergens.

Background Sepsis is the leading cause of death in US hospitals. Compliance with bundled care, specifically serial lactates, blood cultures, and antibiotics, improves outcomes but is often delayed or missed altogether in a busy practice environment. Objective This study aims to design, implement, and validate a novel monitoring and alerting platform that provides real-time feedback to frontline emergency department (ED) providers regarding adherence to bundled care. Methods This single-center, prospective, observational study was conducted in three phases: the design and technical development phase to build an initial version of the platform; the pilot phase to test and refine the platform in the clinical setting; and the postpilot rollout phase to fully implement the study intervention. Results During the design and technical development, study team members and stakeholders identified the criteria for patient inclusion, selected bundle measures from the Center for Medicare and Medicaid Sepsis Core Measure for alerting, and defined alert thresholds, message content, delivery mechanisms, and recipients. Additional refinements were made based on 70 provider survey results during the pilot phase, including removing alerts for vasopressor initiation and modifying text in the pages to facilitate patient identification. During the 48 days of the postpilot rollout phase, 15,770 ED encounters were tracked and 711 patient encounters were included in the active monitoring cohort. In total, 634 pages were sent at a rate of 0.98 per attending physician shift. Overall, 38.3% (272/711) patients had at least one page. The missing bundle elements that triggered alerts included: antibiotics 41.6% (136/327), repeat lactate 32.4% (106/327), blood cultures 20.8% (68/327), and initial lactate 5.2% (17/327). Of the missing Sepsis Core Measures elements for which a page was sent, 38.2% (125/327) were successfully completed on time. Conclusions A real-time sepsis care monitoring and alerting platform was created for the ED environment. The high proportion of patients with at least one alert suggested the significant potential for such a platform to improve care, whereas the overall number of alerts per clinician suggested a low risk of alarm fatigue. The study intervention warrants a more rigorous evaluation to ensure that the added alerts lead to better outcomes for patients with sepsis.

BACKGROUND Sepsis is the leading cause of death in US hospitals. Compliance with bundled care, specifically serial lactates, blood cultures, and antibiotics, improves outcomes but is often delayed or missed altogether in a busy practice environment. OBJECTIVE This study aims to design, implement, and validate a novel monitoring and alerting platform that provides real-time feedback to frontline emergency department (ED) providers regarding adherence to bundled care. METHODS This single-center, prospective, observational study was conducted in three phases: the design and technical development phase to build an initial version of the platform; the pilot phase to test and refine the platform in the clinical setting; and the postpilot rollout phase to fully implement the study intervention. RESULTS During the design and technical development, study team members and stakeholders identified the criteria for patient inclusion, selected bundle measures from the Center for Medicare and Medicaid Sepsis Core Measure for alerting, and defined alert thresholds, message content, delivery mechanisms, and recipients. Additional refinements were made based on 70 provider survey results during the pilot phase, including removing alerts for vasopressor initiation and modifying text in the pages to facilitate patient identification. During the 48 days of the postpilot rollout phase, 15,770 ED encounters were tracked and 711 patient encounters were included in the active monitoring cohort. In total, 634 pages were sent at a rate of 0.98 per attending physician shift. Overall, 38.3% (272/711) patients had at least one page. The missing bundle elements that triggered alerts included: antibiotics 41.6% (136/327), repeat lactate 32.4% (106/327), blood cultures 20.8% (68/327), and initial lactate 5.2% (17/327). Of the missing Sepsis Core Measures elements for which a page was sent, 38.2% (125/327) were successfully completed on time. CONCLUSIONS A real-time sepsis care monitoring and alerting platform was created for the ED environment. The high proportion of patients with at least one alert suggested the significant potential for such a platform to improve care, whereas the overall number of alerts per clinician suggested a low risk of alarm fatigue. The study intervention warrants a more rigorous evaluation to ensure that the added alerts lead to better outcomes for patients with sepsis.

Objective Clinicians may hesitate to advocate for autopsies out of concern for increased malpractice risk if the pathological findings at time of death differ from the clinical findings. We aimed to understand the impact of autopsy findings on malpractice claim outcomes. Methods Closed malpractice claims with loss dates between 1995 and 2015 involving death related to inpatient care at 3 Harvard Medical School hospitals were extracted from a captive malpractice insurer's database. These claims were linked to patients' electronic health records and their autopsy reports. Using the Goldman classification system, 2 physician reviewers blinded to claim outcome determined whether there was major, minor, or no discordance between the final clinical diagnoses and pathologic diagnoses. Claims were compared depending on whether an autopsy was performed and whether there was major versus minor/no clinical-pathologic discordance. Primary outcomes included percentage of claims paid through settlement or plaintiff verdict and the amount of indemnity paid, inflation adjusted. Results Of 293 malpractice claims related to an inpatient death that could be linked to patients' electronic health records, 89 claims (30%) had an autopsy performed by either the hospital or medical examiner. The most common claim allegation was an issue with clinician diagnosis, which was statistically less common in the autopsy group (18% versus 38%, P = 0.001). There was no difference in percentage of claims paid whether an autopsy was performed or not (42% versus 41%, P = 0.90) and no difference in median indemnity of paid claims after adjusting for number of defendants ($1,180,537 versus $906,518, P = 0.15). Thirty-one percent of claims with hospital autopsies performed demonstrated major discordance between autopsy and clinical findings. Claims with major clinical-pathologic discordance also did not have a statistically significant difference in percentage paid (44% versus 41%, P > 0.99) or amount paid ($895,954 versus $1,494,120, P = 0.10) compared with claims with minor or no discordance. Conclusions Although multiple factors determine malpractice claim outcome, in this cohort, claims in which an autopsy was performed did not result in more paid outcomes, even when there was major discordance between clinical and pathologic diagnoses.

BACKGROUND The number of physician assistants (PAs) and advanced practice registered nurses (APRNs), together known as advanced practice providers (APPs), has risen dramatically. The goal is identifying characteristics of paid medical malpractice claims, in which APPs are defendants. METHODS Retrospective cohort study using Harvard's malpractice insurer's national database. Closed claims (2007-2016) with PAs, APRNs, or physicians as defendants. The primary analysis compared claims by role group by patient-, provider-, and claim-level characteristics. Supplemental analyses compared claims naming APPs with and without physicians. Multivariable logistic regression identified variables associated with claim payment. RESULTS Of 54,772 claims, PAs were defendants without APRNs or physicians in 26 claims; APRNs were defendants without PAs or physicians in 63; physicians were defendants without PAs or APRNs in 37,354. Approximately 75% of claims naming APPs co-named physicians. More claims naming PAs and APRNs were paid on behalf of the hospital/practice (38% and 32%, respectively) compared with physicians (8%, P < 0.001). Payment was less likely for inpatient care (OR 0.89, 95% CI 0.85-0.93, P < 0.001) but higher when APRNs were defendants (1.82, 1.09-3.03), when procedure-related (1.31, 1.25-1.38, P < 0.001) or patients died (1.09, 1.03-1.16, P = 0.003). CONCLUSIONS These results can inform patient safety initiatives to prevent future harms. The target is outpatient airway procedures performed by APRNs.

OBJECTIVE: To investigate risk‐adjusted, 30‐day postdischarge heart failure mortality and readmission rates stratified by hospital teaching intensity. DATA SOURCES AND STUDY SETTING: A total of 709 221 Medicare fee‐for‐service beneficiaries discharged from 3135 US hospitals between 1/1/2013 and 11/30/2014 with a principal diagnosis of heart failure. STUDY DESIGN: Hospitals were classified as Council of Teaching Hospitals and Health Systems (COTH) major teaching hospitals, non‐COTH teaching hospitals, and nonteaching hospitals. Hospital teaching status was linked with MedPAR patient data and FY2016 Hospital Readmission Reduction Program penalties. Index hospitalization survival probabilities were estimated with hierarchical logistic regression and used to stratify index hospitalization survivors into severity deciles. Decile‐specific models were estimated for 30‐day postdischarge readmission and mortality. Thirty‐day postdischarge outcomes were estimated by teaching intensity and penalty categories. PRINCIPAL FINDINGS: Averaged across deciles, adjusted 30‐day COTH hospital readmission rates were, on a relative scale ([COTH minus nonteaching] ÷ nonteaching), 1.63 percent higher (95% CI: 0.89 percent, 2.25 percent) than at nonteaching hospitals, but their average adjusted 30‐day postdischarge mortality rates were 11.55 percent lower (95% CI: −13.78 percent, −9.37 percent). Penalized COTH hospitals had the highest readmission rates of all categories (23.99 percent [95% CI: 23.50 percent, 24.49 percent]) but the lowest 30‐day postdischarge mortality (8.30 percent [95% CI: 7.99 percent, 8.57 percent] vs 9.84 percent [95% CI: 9.69 percent, 9.99 percent] for nonpenalized, nonteaching hospitals). CONCLUSIONS: Heart failure readmission penalties disproportionately impact major teaching hospitals and inadequately credit their better postdischarge survival.

Background Patient experience is becoming an area of interest in Emergency Medicine as more is understood about its impact on outcomes and the expectation that it will soon be tied to reimbursement. No study has investigated the predictors of emergency department (ED) patient satisfaction in over a decade. As the care environment, access to information, and consumer interests change, determinants of satisfaction have likely evolved. Our objective was to examine the factors that were most predictive of ED satisfaction. Methods A retrospective cohort study at an urban, university-affiliated ED. The relationship between overall satisfaction and patients' responses to individual questions was assessed using a chi-square test and a multivariable logistic regression model. Results During the study period, 7,872 patients participated in a telephone interview. Logistic regression found 13 questions predictive of high overall ED rating and 9 questions predictive of low overall ED rating. Six questions appeared in both analyses, related to timeliness, cleanliness, the physician's ability to listen carefully, teamwork, and the perception of being helped by the care. Conclusions There are strong predictors of overall ED satisfaction related to communication, wait time, environment, and perception that care was helpful. Further efforts should focus on identifying interventions in each of these domains.

Background: Patient-centered approaches in the evaluation of patient experience are increasingly important priorities for quality improvement in health-care delivery. Our objective was to investigate common themes in patient-reported data to better understand areas for improvement in the emergency department (ED) experience. Methods: A large urban, tertiary-care ED conducted phone interviews with 2607 patients who visited the ED during 2015. Patients were asked to identify one area that would have significantly improved their visit. Transcripts were analyzed using content analysis, and the results were summarized with descriptive statistics. Results: The most commonly cited themes for improvement in the patient experience were wait time (49.4%) and communication (14.6%). Related, but more nuanced, themes emerged around the perception of ED crowding and compassionate care as additional important contributors to the patient experience. Other frequently cited factors contributing to a negative experience were the discharge process and inability to complete follow-up plan (8.0%), environmental factors (7.9%), perceived competency of providers in the evaluation or treatment (7.4%), and pain management (7.4%). Conclusions: Wait times and perceptions of ED crowding, as well as provider communication and compassionate care, are significant factors identified by patients that affect their ED experience.

Patient–provider communication has been recognized as a critical area of focus for improved health care quality, with a mounting body of evidence tying patient satisfaction and provider communication to important health care outcomes. Despite this, few programs have been studied in the emergency department (ED) setting. The authors designed a communication curriculum and conducted trainings for all ED clinical staff. Although only 72% of clinicians believed the course would be a valuable use of their time before taking it, 97% reported that it was a valuable use of their time after ( P < .001). Pre-course self-evaluation of knowledge, skill, and ability were high. Despite this, post-course self-efficacy improved statistically significantly. This study suggests that it is possible, in a brief training session, to deliver communication content that participants felt was relevant to their practice, improved their skills and knowledge, changed their attitude, and was perceived to be a valuable use of their time.

Safety assessment codes (SACs) are one method to evaluate adverse events and determine the need for a root cause analysis. Few facilities currently use SACs, and there is no literature examining their interrater reliability. Two independent raters assigned frequency, actual harm, and potential harm ratings to a sample of patient safety reports. An actual and potential SAC were determined. Percent agreement and Cohen's κ were calculated. Substantial agreement existed for the actual SAC (κ = 0.626, P < .001), fair agreement for the potential SAC (κ = 0.266, P < .001), and low agreement for potential harm (κ = 0.171, P = .002). Although there is subjectivity in all aspects of assigning SACs, the greatest is in potential severity. This presents a problem when using the potential SAC and is in agreement with previous literature showing significant subjectivity in determining potential harm. An operational framework is needed to strengthen reliability.

Incident reporting is a recognized tool for healthcare quality improvement. These systems, which aim to capture near-misses and harm events, enable organizations to gather critical information about failure modes and design mitigation strategies. Although many hospitals have employed these systems, little is known about safety themes in emergency medicine incident reporting. Our objective was to systematically analyze and thematically code 1 year of incident reports.A mixed-methods analysis was performed on 1 year of safety reporting data from a large, urban tertiary-care emergency department using a modified grounded theory approach.Between January 1 and December 31, 2015, there were 108,436 emergency department visits. During this time, 750 incident reports were filed. Twenty-nine themes were used to code the reports, with 744 codes applied. The most common themes were related to delays (138/750, 18.4%), medication safety (136/750, 18.1%), and failures in communication (110/750, 14.7%). A total of 48.8% (366/750) of reports were submitted by nurses.The most prominent themes during 1 year of incident reports were related to medication safety, delays, and communication. Relative to hospital-wide reporting patterns, a higher proportion of reports were submitted by physicians. Despite this, overall incident reporting remains low, and more is needed to engage physicians in reporting.

Background The release of the Center for Medicare and Medicaid Service's (CMS) latest quality measure, Severe Sepsis/Septic Shock Early Management Bundle (SEP-1), has intensified the long-standing debate over optimal care for severe sepsis and septic shock. Although the last decade of research has demonstrated the importance of comprehensive bundled care in conjunction with compliance mechanisms to reduce patient mortality, it is not clear that SEP-1 achieves this aim. The heterogeneous and often cryptic presentation of severe sepsis and septic shock, along with the multifaceted criteria for the definition of this clinical syndrome, pose a particular challenge for fitting requirements to this disease, and implementation could have unintended consequences. Objective Following a simulated reporting exercise, in which 50 charts underwent expert review, we aimed to detail the challenges of, and offer suggestions on how to rethink, measuring performance in severe sepsis and septic shock care. Discussion There were several challenges associated with the design and implementation of this measure. The ambiguous definition of severe sepsis and septic shock, prescriptive fluid volume requirements, rigid reassessment, and complex abstraction logic all raise significant concern. Conclusions Although SEP-1 represents an important first step in requiring hospitals to improve outcomes for patients with severe sepsis and septic shock, the current approach must be revisited. The volume and complexity of the currently required SEP-1 reporting elements deserve serious consideration and revision before they are used as measures of accountability and tied to reimbursement.

QUALITY ISSUE Emergency department overcrowding has been identified as a quality and patient safety concern. INITIAL ASSESSMENT The need for a project focused on mitigating risk in the setting of overcrowding was identified. CHOICE OF SOLUTION Design thinking is an improvement methodology that uses a process that prioritizes empathy for end users and is optimal for abstract problems. IMPLEMENTATION The team leveraged design thinking to walk through a 5-step process. In the empathize phase, inputs were collected and safety themes identified. In the define phase, optimal communication was identified as the focus area of the project. During the ideate phase, the team looked both internally and externally to identify tactics that existed to improve communication. Next, the team prototyped different solutions. In the testing phase, 33 trainings with 289 clinicians were conducted. EVALUATION The evaluation of this program demonstrated that it was positively received by clinicians. Although only 72% of clinicians believed the course would be a valuable use of their time before taking it, 97% reported it was a valuable use of their time following completion (P < .001). Precourse self-evaluation of knowledge, skill, and ability was high. Despite this, postcourse self-efficacy improved significantly in all 4 domains studied. LESSONS LEARNED Design thinking offers an agile method for process improvement that was ideal for our relatively abstract problem. Although likely not an optimal method for a problem that is well understood, design thinking holds promise for many of the increasingly patient-centered initiatives that are underway in health care.

PURPOSE To identify patient-, provider-, and claim-related factors of medical malpractice claims in which physician trainees were directly involved in the harm events. METHOD The authors performed a case-control study using medical malpractice claims closed between 2012-2016 and contributed to the Comparative Benchmarking System database by teaching hospitals. Using the service extender flag, they classified claims as cases if physician trainees were directly involved in the harm events. They classified claims as controls if they were from the same facilities, but trainees were not directly involved in the harm events. They performed multivariable regression with predictor variables being patient and provider characteristics. The outcome was physician trainee involvement in harm events. RESULTS From the original pool of 30,973 claims, there were 581 cases and 2,610 controls. The majority of cases involved residents (471, 81%). Cases had a statistically significant higher rate of having a trainee named as defendants than controls (184, 32% vs 233, 9%; P < .001). The most common final diagnosis for cases was puncture or laceration during surgery (62, 11%). Inadequate supervision was a contributing factor in 140 (24%) cases overall, with the majority (104, 74%) of these claims being procedure related. Multivariable regression analysis revealed that trainees were most likely to be involved in harm events in specialties such as oral surgery/dentistry and obstetrics-gynecology (OR = 7.99, 95% CI 2.93, 21.83 and OR = 1.85, 95% CI 1.24, 2.66, respectively), when performing procedures (OR = 1.58, 95% CI 1.27, 1.96), or when delivering care in the emergency room (OR = 1.65, 95% CI 1.43, 1.91). CONCLUSIONS Among claims involving physician trainees, procedures were common and often associated with inadequate supervision. Training directors of surgical specialties can use this information to improve resident supervision policies. The goal is to reduce the likelihood of future harm events.

Background Surgeons are prone to feelings of sadness, guilt, and anxiety when involved in major adverse events. We aimed to create and evaluate a second victim peer support program for surgeons and surgical trainees. Study Design The second victim peer support program was an intervention performed in the Department of Surgery at a tertiary care academic medical center. Surgical attendings and trainees participated as peer supporters or affected peers. In this article, we describe the design of the program and its 1-year impact, which was evaluated through the number of interventions attempted and realized and feedback received from all participants using an anonymous qualitative and quantitative survey. Results The program was established using the following 5 steps: creation of a conceptual framework, choice of peer supporters, training of peer supporters, multifaceted identification of major adverse events, and design of a systematic intervention plan. In 1 year, the program had 47 interventions distributed evenly between attendings and trainees; 19% of affected peers opted out of receiving support. Most participants expressed satisfaction with the program's confidentiality, the safe/trusting environment it provided, and the timeliness of the intervention (89%, 73%, and 83%, respectively); 81% suggested that the program had a positive impact on the department's “safety and support” culture and would recommend the program to a colleague. Several areas for improvement were identified, including the need to improve identification of events requiring outreach, and the desire for increased awareness of the program throughout the department. Conclusions We successfully designed, implemented, and assessed the impact of the first surgery-specific peer support program in the US. Our 1-year experience suggests that the program is highly used and well received, albeit with opportunities for improvement.

Given their profound emotional, physical, and financial toll on patients and surgeons, we studied the characteristics, costs, and contributing factors of thyroid and parathyroid surgical malpractice claims. Using the Controlled Risk Insurance Company Strategies’ Comparative Benchmarking System database, representing ~30% of all US paid and unpaid malpractice claims, 5384 claims filed against general surgeons and otolaryngologists from 1995–2015 were reviewed to isolate claims involving the surgical management of thyroid and parathyroid disease. These claims were studied, and multivariable regression analysis was performed to identify factors associated with plaintiff payout. One hundred twenty-eight thyroid and parathyroid surgical malpractice claims were isolated. The median time from alleged harm event to closure of a malpractice case was 39 months. The most common associated complications were bilateral recurrent laryngeal nerve (RLN) injury (n = 23) and hematoma (n = 18). Complications led to death in 18 cases. Patient payout occurred in 33% of claims (n = 42), and the median cost per claim was $277,913 (IQR $87,343–$783,663). On multivariable analysis, bilateral RLN injury was predictive of patient payout (OR 3.58, p = 0.03), while procedure, death, and surgeon specialty were not. Though rare, malpractice claims related to thyroid and parathyroid surgery are costly, time-consuming, and reveal opportunities for early surgeon–patient resolution after poor outcomes.

A variety of hospital characteristics, including teaching status, ownership, location, and size, have been shown to be associated with quality measure performance. The association of hospital characteristics, including teaching intensity, with performance on the Centers for Medicare & Medicaid Services (CMS) SEP-1 sepsis measure has not been well studied. Utilizing a statewide, all-payer database and the CMS Hospital Compare database, this study investigated the association of various hospital characteristics with early SEP-1 performance in 48 acute hospitals in Massachusetts. Hospital teaching intensity and Magnet designation did not have a statistically significant association with SEP-1 performance in multivariable linear modeling. However, SEP-1 performance was higher in smaller, for-profit hospitals with higher case mix index. This finding suggests that emergency department activity, hospital ownership, and patient complexity should be studied further across a larger geographic spectrum and longitudinally as hospitals implement efforts to reduce morbidity associated with sepsis.

Background The epidemiology of hospital adverse reactions (ARs), particularly allergic reactions, or hypersensitivity reactions (HSRs), is poorly defined. To determine priorities for allergy safety in healthcare, we identified and described safety reports of allergic reactions. Methods We searched the safety report database of a large academic medical center from April 2006 to March 2016 using 101 complete, truncated, and/or misspelled key words related to allergic symptoms, treatments, and culprits (e.g., medications, foods). Patient and event data were summarized for ARs and two types of ARs, HSRs and side effects/toxicities. Results Among 9111 key word search-identified events, 876 (10%) were ARs, of which 436 (5%) were HSRs and the remaining 440 (5%) were side effect reactions or toxicities. Whereas the most common HSRs were simple cutaneous reactions (83%), the following severe immediate HSRs were also identified: shortness of breath (16%), anaphylaxis (14%), and angioedema (12%). Most HSRs were caused by drugs (81%), with antibiotics (26%), particularly β-lactams (11%), and vancomycin (8%), commonly implicated. Other causes of drug HSRs included contrast agents (24%), chemotherapeutics (7%), and opioids (6%). Nondrug HSRs were from blood products (8%), latex (3%), and devices (3%). Food reactions were rarely identified (1%). Conclusions We identified ARs, HSRs, and side effects/toxicities, contained in a decade of safety reports at an academic medical center. Allergy safety in the healthcare setting should target approaches to common and severe reactions, with a focus on the safe administration of β-lactams, vancomycin, contrast agents, chemotherapeutics, and opioids. Priority nondrug HSR culprits include blood products, latex, and devices.

INTRODUCTION Patient compliance with preoperative mechanical and antibiotic bowel preparation, skin washes, carbohydrate loading, and avoidance of fasting are key components of successful colorectal ERAS and surgical site infection (SSI)-reduction programs. In July 2016, we began a quality improvement project distributing a free SSI Prevention Kit (SSIPK) containing patient instructions, mechanical and oral bowel preparation, chlorhexidine washes, and carbohydrate drink to all patients scheduled for elective colectomy, with the goal of improving patient compliance and rates of SSI. METHODS This was a prospective data audit of our first 221 SSIPK+ patients, who were compared to historical controls (SSIPK-) of 1760 patients undergoing elective colectomy from January 2013 to March 2017. A 1:1 propensity score system accounted for nonrandom treatment assignment. Matched patients' complications, particularly postoperative infection and ileus, were compared. RESULTS SSIPK+ (n = 219) and SSIPK- (n = 219) matched patients were statistically identical on demographics, comorbidities, BMI, surgical indication, and procedure. SSIPK+ patients had higher compliance with mechanical (95% vs 71%, P < 0.001) and oral antibiotic (94% vs 27%, P < 0.001) bowel preparation. This translated into lower overall SSI rates (5.9% vs 11.4%, P = 0.04). SSIPK+ patients also had lower rates of anastomotic leak (2.7% vs 6.8%, P = 0.04), prolonged postoperative ileus (5.9% vs 14.2%, P < 0.01), and unplanned intubation (0% vs 2.3%, P = 0.02). Furthermore, SSIPK+ patients had shorter mean hospital length of stay (3.1 vs 5.4 d, P < 0.01) and had fewer unplanned readmissions (5.9% vs 14.6%, P < 0.001). There were no differences in rates of postoperative pneumonia, urinary tract infection, Clostridium difficile colitis, sepsis, or death. CONCLUSION Provision of a free-of-charge SSIPK is associated with higher patient compliance with preoperative instructions and significantly lower rates of surgical site infections, lower rates of prolonged postoperative ileus, and shorter hospital stays with fewer readmissions. Widespread utilization of such a bundle could therefore lead to significantly improved outcomes.

Despite decades of investment in patient safety, unintentional patient harm remains a major challenge in the health care industry. Peer-to-peer assessment in the nuclear industry has been shown to reduce harm. The study team’s goal was to pilot and assess the feasibility of this approach in health care. The team developed tools and piloted a peer-to-peer assessment at 2 academic hospitals: Massachusetts General Hospital and Johns Hopkins Hospital. The assessment evaluated both the institutions’ organizational approach to quality and safety as well as their approach to reducing 2 specific areas of patient harm. Site visits were completed and consisted of semistructured interviews with institutional leaders and clinical staff as well as direct patient observations using audit tools. Reports with recommendations were well received and each institution has developed improvement plans. The study team believes that peer-to-peer assessment in health care has promise and warrants consideration for wider adoption.

The prevalence of back pain is rising, as is the use of high-cost imaging in the ED. The objective of our study was to determine if an MRI in the ED for patients with back pain resulted in a lower incidence of ED return visit and to determine if these patients had longer ED length of stay (LOS) and use of ED observation.A retrospective cohort study of consecutive patients seen with back pain was conducted at an urban, university-affiliated ED between 1 January 2012 and 11 July 2014. The association of MRI on return within 7 days was assessed using a χDuring the study period, 6094 patients were evaluated in the ED with back pain as the primary diagnosis. Of these, 797 (13%) received an MRI. Among all patients with back pain, 277 (4.5%) returned within 7 days. Univariate analysis found that patients who received an MRI were no less likely to return within 7 days than patients who did not (4.3% vs 4.6%; p=0.68). Patients who had an MRI were more likely to be admitted to observation (74.2% vs 10.8%; p0.0001) and had a longer ED LOS (median 4.8 hours vs 2.7; p0.0001). Multivariable regression confirmed that MRI did not decrease the rate of a 7-day return visit (OR=0.98; 95% CI 0.68 to 1.42).In patients with uncomplicated back pain, performing an MRI will not mitigate their likelihood of return; however, it leads to a longer ED LOS and more ED observation admissions.

Background: Patients with intracerebral hemorrhage (ICH) are frequently transferred between hospitals in anticipation of the need for higher level of care than locally available. We aimed to identify factors that are associated with increased resource utilization among patients with ICH transferred to a single academic hospital. Methods: We utilized data on patients with primary ICH at urban academic hospital between 01/01/2005-12/31/2015 from a prospectively collected registry of consecutive patients. Those with trauma, aneurysm, tumor, or other types of secondary ICH were excluded. Disease severity was calculated using the ICH score at time of presentation. The primary outcome (care that may not be available at the sending hospital) was operationally defined as use of either ICU admission or surgical intervention. We used logistic regression to examine predictors of ICU stay or surgical intervention, controlling for age, sex, race/ethnicity, insurance status, anticoagulation use, and past history of stroke or ICH. Results: During the study period, 2008 patients met inclusion criteria, 71% of whom presented as transfers. ICU stay or surgical intervention was required in 887 (44.2%). Patient requiring ICU stay or surgical intervention were younger (mean age 71 vs. 74 years, p65 years (OR 0.38, 95% CI 0.21-0.69), GCS0 (OR 2.23, 95% CI 1.70-2.91). Conclusion: Among this cohort of patients with primary ICH, those with GCS of 15 and ICH score of 0 were less likely to require ICU stay or surgical intervention. These results should be validated in a larger sample but may be valuable for hospitals considering which ICH patients should be transferred to a tertiary care center.

Morphine has traditionally been considered the first line agent for analgesia in hospitals; however, in the last few years there has been a shift towards the use of hydromorphone as a first line agent. We conducted a hospital population based observational study to evaluate the increasing use of hydromorphone over morphine in both medical and surgical populations. Additionally, we assessed the effect of this trend on three key outcomes, including adverse events, length of stay, and readmission rates. We evaluated data from the University Health Systems Consortium. Data from 38 hospitals from October 2010 to September 2013 was analyzed for patients treated with either hydromorphone or morphine. The use of morphine steadily decreased while use of hydromorphone increased in both medical and surgical groups. Rescue drugs were used more frequently in patients treated with hydromorphone in comparison to patients treated with morphine (p<0.01). Patients receiving morphine tended to stay in the hospital for almost one day longer than patients receiving hydromorphone. However, 30-day all cause readmission rates were significantly higher in patients treated with hydromorphone (p<0.01). Our study highlights that the choice of hydromorphone versus morphine may influence outcomes. There are implications related to resource utilization and these outcomes.

Background Patients who return to the Emergency Department (ED) within 72 h of discharge are often used for ED Quality Assurance efforts, however little is known about the yield of this kind of review and the types of errors it identifies. Our objective was to identify the prevalence, types and severity of errors in these cases. Methods Retrospective review of patients who presented to an urban, university affiliated ED between 10/1/2012–9/30/2015 who returned within 72 h requiring hospital admission. Results There were 413,167 ED visits during the study period with 2001 (0.48%) patients who returned within 72 h and were admitted to the hospital. An event requiring further investigation was identified in 59 (2.95%) of these patients and 50 (2.49%) of them were deemed to represent a deviation from optimal care. Of these, 48 (96%) represented diagnostic error. When a standard diagnostic process of care framework was applied to these, the majority of cases represented failures in the initial diagnostic pathway (29 cases, 60.4%). When Error Severity Codes were applied, 16 (32%) resulted in minor harm and 34 (68%) resulted in major harm or death. Conclusion Screening of 72 h ED returns has low yield in identifying suboptimal care, with less than 3% of cases representing deviations from standard care. Of these, the majority represent cognitive errors in the diagnostic pathway. These reviews may be useful as a tool for Ongoing Professional Practice Evaluation of individual clinicians, however likely serve less value in identifying systems issues contributing to unsafe care.

Background More than half of the 50 states (27) and the District of Columbia require reporting of Serous Reportable Events (SREs). The goal is to hold providers accountable and improve patient safety, but there is little information about the administrative cost of this reporting requirement. This study was conducted to identify costs associated with investigating and reporting SREs. Methods This qualitative study used case study methods that included interviewing staff and review of data and documents to investigate each SRE occurring at one academic medical center during fiscal year 2013. A framework of tasks and a model to categorize costs was created. Time was summarized and costs were estimated for each SRE. Results The administrative cost to process 44 SREs was estimated at $353,291, an average cost of $8,029 per SRE, ranging $6,653 for an environmental-related SRE to $21,276 for a device-related SRE. Care management SREs occurred most frequently, costing an average $7,201 per SRE. Surgical SREs, the most expensive on average, cost $9,123 per SRE. Investigation of events accounted for 64.5% of total cost; public reporting, 17.2%; internal reporting, 10.2%; finance and administration, 6.0%; and 2.1%, other. Even with 26 states mandating reporting, the 17.2% incremental cost of public reporting is substantial. Conclusion Policy makers should consider the opportunity costs of these resources, averaging $8,029 per SRE, when mandating reporting. The benefits of public reporting should be collectively reviewed to ensure that the incremental costs in this resource-constrained environment continue to improve patient safety and that trade-offs are acknowledged.

Background The reclassification of noninvasive encapsulated follicular variant of papillary thyroid cancer to noninvasive follicular thyroid neoplasm with papillary-like nuclear features will reduce nonefficacious and potentially harmful care. Reclassification is estimated in 18.6% of patients with papillary thyroid carcinoma; we aimed to quantify the implications of this change. Methods Pathology reports from April 2006 to April 2016 were reviewed to isolate cases that would have been designated as neoplasm with papillary-like nuclear features. Of the 1,335 cases of papillary thyroid carcinomas, 194 cases (14.5%) met criteria. Cases in which neoplasm with papillary-like nuclear features was found in combination with other thyroid malignancies (n = 25) and cases of prior thyroid lobectomy (n = 5) were excluded. Demographic, pathologic, treatment, and follow-up data were assessed for the remaining 164 potential neoplasm with papillary-like nuclear features cases. Logistic regression analysis was performed to evaluate association between fine-needle aspiration result and index procedure. Results Of the 164 patients with tumors who met neoplasm with papillary-like nuclear features criteria, fine-needle aspiration results were nondiagnostic (2%), benign (18%), atypia/follicular lesion of undetermined significance (26%), follicular neoplasm or suspicious for follicular neoplasm (20%), suspicious for malignancy (19%), malignant (6%), and not obtained (9%). Eighty-five (52%) patients underwent total thyroidectomy. A “suspicious for malignancy” fine-needle aspiration result was associated with undergoing total thyroidectomy versus thyroid lobectomy (P = .006). Thyroid lobectomy was the index procedure for 79 patients (48%); of these patients, 54% (n = 43, 3.2% of all patients with papillary thyroid carcinomas) underwent subsequent total thyroidectomy, and 24% received postoperative radioactive iodine treatment. There were no recurrences among the 125 patients with >3 months of follow-up. Conclusion The reclassification of noninvasive encapsulated follicular variant of papillary thyroid cancer as neoplasm with papillary-like nuclear features will decrease nonefficacious treatment and reduce costs. However, the impact of this change with regard to extent of surgery was limited to 3.2% of patients with papillary thyroid carcinomas compared with the projected potential impact on 18.6%.

The Harvard Fellowship in Patient Safety and Quality is a 2-year physician-oriented training program with a strong operational orientation, embedding trainees in the quality departments of participating hospitals. It also integrates didactic and experiential learning and offers the option of obtaining a master's degree in public health. The program focuses on methodologically rigorous improvement and measurement, with an emphasis on the development and implementation of innovative practice. The operational orientation is intended to foster the professional development of future quality and safety leaders. The purpose of this article is to describe the design and development of the fellowship.

Background— For patients who undergo primary percutaneous coronary intervention (PCI) for ST-segment–elevation myocardial infarction, the door-to-balloon time is an important performance measure reported to the Centers for Medicare & Medicaid Services (CMS) and tied to hospital quality assessment and reimbursement. We sought to assess the use and impact of exclusion criteria associated with the CMS measure of door-to-balloon time in primary PCI. Methods and Results— All primary PCI-eligible patients at 3 Massachusetts hospitals (Brigham and Women’s, Massachusetts General, and North Shore Medical Center) were evaluated for CMS reporting status. Rates of CMS reporting exclusion were the primary end points of interest. Key secondary end points were between-group differences in patient characteristics, door-to-balloon times, and 1-year mortality rates. From 2005 to 2011, 26% (408) of the 1548 primary PCI cases were excluded from CMS reporting. This percentage increased over the study period from 13.9% in 2005 to 36.7% in the first 3 quarters of 2011 ( P P Conclusions— More than a quarter of patients who underwent primary PCI were excluded from hospital quality reports collected by CMS, and this percentage has grown substantially over time. These findings may have significant implications for our understanding of process improvement in primary PCI and mechanisms for reimbursement through Medicare.

Background Healthcare has become increasingly complex and care delivery models have changed dramatically (eg, team-based care, duty-hour restrictions). However, approaches to critical communications among providers have not evolved to meet these new challenges. Evidence from safety culture surveys, academic studies and malpractice claims suggests that healthcare handover quality is problematic, leading to preventable errors and adverse outcomes. To address this concern, from 2013 to 2016 Massachusetts General Hospital completed phase I of a multifaceted programme to implement standardised, structured handovers across all departments, units and direct care providers. Methods A multidisciplinary Handovers Committee selected the I-PASS handover system. Phase I implementation focused on large-scale training and shift-to-shift handovers. Important features included administrative and clinical leadership support; EHR templates for I-PASS; hospital handover policy revision; varied educational modalities, venues and durations; concomitant TeamSTEPPS training; unit-level I-PASS champions; handover observations; and solicitation of caregiver feedback and suggestions. Results More than 6000 doctors, nurses and therapists have been trained. Trended observation scores demonstrate progressive but non-uniform adoption of I-PASS, with significant improvements in the correct sequencing and percentage of I-PASS elements included in handovers. Adoption of Synthesis (readback) has been challenging, with lower scores. Conclusions Comprehensive I-PASS implementation in a large academic medical centre necessitated major cultural change. I-PASS education is straightforward, whereas assuring consistent and sustained adoption across all services is more challenging, requiring adaptation of the basic I-PASS structure to local needs and workflows. EHR I-PASS templates facilitated caregiver acceptance. Initial phase I results are encouraging and the lessons learned should be helpful to other programmes planning handover initiatives. Phase II is ongoing, focusing on more uniform and consistent adoption, spread and sustainability.

Emergency Department (ED) overcrowding has become a global concern as the number of countries with formalized emergency care systems has expanded, and the burden of trauma and non-communicable diseases in low and middle-income countries increased. In light of this, the international Emergency Medicine literature has outlined the need for operational projects in low and middle income countries which focus on the process of care. Despite this, there is limited published literature describing these types of projects. We share our experience mapping emergency care processes at a teaching hospital in Ghana as a case study of Lean's application in a relatively resource limited setting. From this work, we conclude that process mapping, a critical first step in further process re-design, is a cost effective, low tech activity which can be feasibly used in low resource environments to initiate quality improvement.

The Massachusetts General Hospital (MGH) Cancer Center is a multidisciplinary cancer center that delivers chemotherapy to 150 to 200 patients daily and adheres to the Oncology Nursing Society and ASCO guidelines for safe chemotherapy administration. An error that occurred at MGH in the summer of 2012 prompted a review of all safety events, the process of classification, and the monitoring of safety events. This article reviews safety monitoring in the oncology setting, details the oncology safety-event reporting program at MGH, summarizes all chemotherapy-related safety events that have occurred over the past 5 years, and concludes with summary recommendations and potential steps to standardize safety reporting and analysis in chemotherapy administration.