Despite considerable emphasis on delivering safe care, substantial patient harm occurs. Although most care occurs in the outpatient setting, knowledge of outpatient adverse events (AEs) remains limited.

BACKGROUND:Despite considerable emphasis on delivering safe care, substantial patient harm occurs. Although most care occurs in the outpatient setting, knowledge of outpatient adverse events (AEs) remains limited. OBJECTIVE:To measure AEs in the outpatient setting. DESIGN:Retrospective review of the electronic health record (EHR). SETTING:11 outpatient sites in Massachusetts in 2018. PATIENTS:3103 patients who received outpatient care. MEASUREMENTS:Using a trigger method, nurse reviewers identified possible AEs and physicians adjudicated them, ranked severity, and assessed preventability. Generalized estimating equations were used to assess the association of having at least 1 AE with age, sex, race, and primary insurance. Variation in AE rates was analyzed across sites. RESULTS:The 3103 patients (mean age, 52 years) were more often female (59.8%), White (75.1%), English speakers (90.8%), and privately insured (70.4%) and had a mean of 4 outpatient encounters in 2018. Overall, 7.0% (95% CI, 4.6% to 9.3%) of patients had at least 1 AE (8.6 events per 100 patients annually). Adverse drug events were the most common AE (63.8%), followed by health care-associated infections (14.8%) and surgical or procedural events (14.2%). Severity was serious in 17.4% of AEs, life-threatening in 2.1%, and never fatal. Overall, 23.2% of AEs were preventable. Having at least 1 AE was less often associated with ages 18 to 44 years than with ages 65 to 84 years (standardized risk difference, -0.05 [CI, -0.09 to -0.02]) and more often associated with Black race than with Asian race (standardized risk difference, 0.09 [CI, 0.01 to 0.17]). Across study sites, 1.8% to 23.6% of patients had at least 1 AE and clinical category of AEs varied substantially. LIMITATION:Retrospective EHR review may miss AEs. CONCLUSION:Outpatient harm was relatively common and often serious. Adverse drug events were most frequent. Rates were higher among older adults. Interventions to curtail outpatient harm are urgently needed. PRIMARY FUNDING SOURCE:Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.

BACKGROUNDAdverse events during hospitalization are a major cause of patient harm, as documented in the 1991 Harvard Medical Practice Study. Patient safety has changed substantially in the decades since that study was conducted, and a more current assessment of harm during hospitalization is warranted.METHODSWe conducted a retrospective cohort study to assess the frequency, preventability, and severity of patient harm in a random sample of admissions from 11 Massachusetts hospitals during the 2018 calendar year. The occurrence of adverse events was assessed with the use of a trigger method (identification of information in a medical record that was previously shown to be associated with adverse events) and from review of medical records. Trained nurses reviewed records and identified admissions with possible adverse events that were then adjudicated by physicians, who confirmed the presence and characteristics of the adverse events.RESULTSIn a random sample of 2809 admissions, we identified at least one adverse event in 23.6%. Among 978 adverse events, 222 (22.7%) were judged to be preventable and 316 (32.3%) had a severity level of serious (i.e., caused harm that resulted in substantial intervention or prolonged recovery) or higher. A preventable adverse event occurred in 191 (6.8%) of all admissions, and a preventable adverse event with a severity level of serious or higher occurred in 29 (1.0%). There were seven deaths, one of which was deemed to be preventable. Adverse drug events were the most common adverse events (accounting for 39.0% of all events), followed by surgical or other procedural events (30.4%), patient-care events (which were defined as events associated with nursing care, including falls and pressure ulcers) (15.0%), and health care-associated infections (11.9%).CONCLUSIONSAdverse events were identified in nearly one in four admissions, and approximately one fourth of the events were preventable. These findings underscore the importance of patient safety and the need for continuing improvement. (Funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.).

Physicians are increasingly asked to assume quality and safety (Q&S) leadership roles; prior experience varies, and onboarding training is limited. Semistructured interviews were completed with physician Q&S leaders; interview responses were analyzed using 2-step rapid analysis. Interview learnings informed development of a 2-day onboarding training and complementary digital resource repository. Attendees were surveyed to evaluate the training. Thirteen semistructured interviews with physician leaders from 6 academic medical centers demonstrated 61.5% had no formal Q&S training before assuming their role. Respondents identified a range of knowledge gaps. A 2-day virtual onboarding training and complementary digital repository were created. Attendee surveys demonstrated 96% (73/76) believed the training would be "extremely" or "moderately" helpful to others. Subject-matter familiarity across all content areas improved after the training. Using front-line stakeholder input, a pilot onboarding curriculum for Q&S leaders was created. Future work includes ongoing implementation and iterative improvement.

Background Toxic work culture contributes to healthcare worker burnout and attrition, but little is known about how healthcare organizations can systematically create and promote a culture of civility and collegiality. Objective To analyze peer-to-peer positive feedback collected as part of a systematized mortality review survey to identify themes and recognition dynamics that can inform positive organizational culture change. Design Convergent mixed-methods study design. Participants A total of 388 physicians, 212 registered nurses, 64 advanced practice providers, and 1 respiratory therapist at four non-profit hospitals (2 academic and 2 community). Intervention Providing optional positive feedback in the mortality review survey. Main Measures Key themes and subthemes that emerged from positive feedback data, associations between key themes and positive feedback respondent characteristics, and recognition dynamics between positive feedback respondents and recipients. Key Results Approximately 20% of healthcare workers provided positive feedback. Three key themes emerged among responses with free text comments: (1) providing extraordinary patient and family-centered care; (2) demonstrating self-possession and mastery; and (3) exhibiting empathic peer support and effective team collaboration. Compared to other specialties, most positive feedback from medicine (70.2%), neurology (65.2%), hospice and palliative medicine (64.3%), and surgery (58.8%) focused on providing extraordinary patient and family-centered care ( p = 0.02), whereas emergency medicine (59.1%) comments predominantly focused on demonstrating self-possession and mastery ( p = 0.06). Registered nurses (40.2%) provided multidirectional positive feedback more often than other clinician types in the hospital hierarchy ( p < 0.001). Conclusions Analysis of positive feedback from a mortality review survey provided meaningful insights into a health system’s culture of teamwork and values related to civility and collegiality when providing end-of-life care. Systematic collection and sharing of positive feedback is feasible and has the potential to promote positive culture change and improve healthcare worker well-being.

OBJECTIVES:To determine if a real-time monitoring system with automated clinician alerts improves 3-hour sepsis bundle adherence. DESIGN:Prospective, pragmatic clinical trial. Allocation alternated every 7 days. SETTING:Quaternary hospital from December 1, 2020 to November 30, 2021. PATIENTS:Adult emergency department or inpatients meeting objective sepsis criteria triggered an electronic medical record (EMR)-embedded best practice advisory. Enrollment occurred when clinicians acknowledged the advisory indicating they felt sepsis was likely. INTERVENTION:Real-time automated EMR monitoring identified suspected sepsis patients with incomplete bundle measures within 1-hour of completion deadlines and generated reminder pages. Clinicians responsible for intervention group patients received reminder pages; no pages were sent for controls. The primary analysis cohort was the subset of enrolled patients at risk of bundle nonadherent care that had reminder pages generated. MEASUREMENTS AND MAIN RESULTS:The primary outcome was orders for all 3-hour bundle elements within guideline time limits. Secondary outcomes included guideline-adherent delivery of all 3-hour bundle elements, 28-day mortality, antibiotic discontinuation within 48-hours, and pathogen recovery from any culture within 7 days of time-zero. Among 3,269 enrolled patients, 1,377 had reminder pages generated and were included in the primary analysis. There were 670 (48.7%) at-risk patients randomized to paging alerts and 707 (51.3%) to control. Bundle-adherent orders were placed for 198 intervention patients (29.6%) versus 149 (21.1%) controls (difference: 8.5%; 95% CI, 3.9-13.1%; p = 0.0003). Bundle-adherent care was delivered for 152 (22.7%) intervention versus 121 (17.1%) control patients (difference: 5.6%; 95% CI, 1.4-9.8%; p = 0.0095). Mortality was similar between groups (8.4% vs 8.3%), as were early antibiotic discontinuation (35.1% vs 33.4%) and pan-culture negativity (69.0% vs 68.2%). CONCLUSIONS:Real-time monitoring and paging alerts significantly increased orders for and delivery of guideline-adherent care for suspected sepsis patients at risk of 3-hour bundle nonadherence. The trial was underpowered to determine whether adherence affected mortality. Despite enrolling patients with clinically suspected sepsis, early antibiotic discontinuation and pan-culture negativity were common, highlighting challenges in identifying appropriate patients for sepsis bundle application.

Patients are harmed too often by the care they receive today. The authors discuss a recent large study of harm, its results in terms of harm incidence, and distribution, and compare these with prior studies of harm in hospitals. The authors suggest what these results imply in terms of improving the safety of care, and how to accelerate it. They go over the roles of boards, and leadership including the c-suite. They discuss metrics and achieving sustainable results. They also evaluate the role of culture, and the future potential of artificial intelligence to improve safety. Overall, there is great room for improvement, but achieving it will require addressing all these areas.

BACKGROUND:Inadequate communication during transitions of care is a major health care quality and safety vulnerability. In 2013 Massachusetts General Hospital (MGH) embarked on a comprehensive training program using a standardized handover system (I-PASS) that had been shown to reduce adverse events by 30% even when not completely executed on each patient. In this cross-sectional study, the authors sought to characterize handover practices six years later.METHODS:Using a standardized interview tool, the researchers evaluated handovers between responding clinicians in 10 departments and then validated these findings through direct observations, allowing for flexibility and customization in the I-PASS elements. The study qualitatively compared I-PASS element use in verbal handovers to MGH early postintervention data, as well as verbal and written handovers with the I-PASS Study Group's postintervention results.RESULTS:The authors observed 156 verbal and reviewed 182 written patient handovers. Ninety percent of departments adhered at least partially to the I-PASS system. Average handover duration ranged from 0.6 to 2.1 minutes per established patient. The service with best I-PASS adherence also consistently included the most information per unit of time. Acknowledging substantial differences in study technique, MGH adherence was, on average, comparable or better on all I-PASS elements in verbal handovers and on three of four elements of written handovers compared with the I-PASS Study Group's postintervention results.CONCLUSION:Although uptake has varied across services, six years after hospitalwide implementation of I-PASS, the majority of services are performing structured and sequenced handovers, most of which include some elements of the I-PASS system. Those services with the best I-PASS adherence conducted the most efficient handovers.

The Centers for Disease Control and Prevention (CDC) measure of severe maternal morbidity (SMM) quantifies the burden of SMM but is not restricted to potentially preventable SMM. The authors adapted the CDC SMM measure for this purpose and evaluated it for use as a hospital performance measure.Guidelines for defining performance SMM (pSMM) were (1) exclusion of preexisting conditions from outcome; (2) exclusion of inconsistently documented outcomes; and (3) risk adjustment for conditions that preceded hospitalization. California maternal hospital discharge data from 2016 to 2017 were used for model development, and 2018 data were used for model testing and evaluation of hospital performance. Separate models were developed for hospital types (Community, Teaching, Integrated Delivery System [IDS], and IDS Teaching), generating model-based expected pSMM values. Observed-to-expected (O/E) ratios were calculated for hospitals and used to categorize them as overperforming, average performing, or underperforming using 95% confidence intervals. Performance categories were compared for pSMM vs. CDC SMM (excluding blood transfusion).The overall 2016–2018 pSMM rate was 0.44%. All hospital types had over- and underperformers, and the proportions of Community, Teaching, IDS, and IDS Teaching hospitals whose performance differed from their performance on the CDC SMM measure were 12.1%, 25.0%, 38.9%, and 66.7%, respectively.The rate of potentially preventable SMM as defined by pSMM (0.44%) was less than half the previously published rate of CDC SMM (1.03%). pSMM identified differences in performance across hospitals, and pSMM and CDC SMM classified hospitals’ performances differently. pSMM may be suitable for hospital comparisons because it identifies potentially preventable, hospital-acquired SMM that should be responsive to quality improvement activities.

Objective To assess the quantity and impact of research publications among US acute care hospitals; to identify hospital characteristics associated with publication volumes; and to estimate the independent association of bibliometric indicators with Hospital Compare quality measures. Data Sources Hospital Compare; American Hospital Association Survey; Magnet Recognition Program; Science Citation Index Expanded. Study Design In cross-sectional studies using a 40% random sample of US Medicare-participating hospitals, we estimated associations of hospital characteristics with publication volumes and associations of hospital-linked bibliometric indicators with 19 Hospital Compare quality metrics. Data Collection/Extraction Methods Using standardized search strategies, we identified all publications attributed to authors from these institutions from January 1, 2015 to December 31, 2016 and their subsequent citations through July 2020. Principal Findings Only 647 of 1604 study hospitals (40.3%) had >= 1 publication. Council of Teaching Hospitals and Health Systems (COTH) hospitals had significantly more publications (average 599 vs. 11 for non-COTH teaching and 0.6 for nonteaching hospitals), and their publications were cited more frequently (average 22.6/publication) than those from non-COTH teaching (18.2 citations) or nonteaching hospitals (12.8 citations). In multivariable regression, teaching intensity, hospital beds, New England or Pacific region, and not-for-profit or government ownership were significant predictors of higher publication volumes; the percentage of Medicaid admissions was inversely associated. In multivariable linear regression, hospital publications were associated with significantly lower risk-adjusted mortality rates for acute myocardial infarction (coefficient -0.52, p = 0.01), heart failure (coefficient -0.74, p = 0.004), pneumonia (coefficient -1.02, p = 0.001), chronic obstructive pulmonary disease (coefficient -0.48, p = 0.005), and coronary artery bypass surgery (coefficient -0.73, p < 0.0001); higher overall Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) ratings (coefficient 2.37, p = 0.04); and greater patient willingness to recommend (coefficient 3.38, p = 0.01). Conclusions A minority of US hospitals published in the biomedical literature. Publication quantity and impact indicators are independently associated with lower risk-adjusted mortality and higher HCAHPS scores.

BackgroundAllergy safety requires understanding the operational processes that expose patients to their known allergens, including how and when such processes fail.ObjectiveTo 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.MethodsUsing 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.ResultsFrom 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).ConclusionsWe 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.

Supplemental digital content is available in the text. 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.