The Safety of Outpatient Health Care : Review of Electronic Health Records.

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.

Long-Term Sustainability and Adaptation of I-PASS Handovers.

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 Safety of Inpatient Health Care.

BACKGROUND: Adverse 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. METHODS: We 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. RESULTS: In 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%). CONCLUSIONS: Adverse 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.).

Expert Consensus on Currently Accepted Measures of Harm.

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.

Interdisciplinary Patient Tracers: Routine, Systematic Safety Surveillance.

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.

Adopting RCA2: The Interrater Reliability of Safety Assessment Codes.

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.

Eculizumab for drug-induced de novo posttransplantation thrombotic microangiopathy: A case report.

De novo thrombotic microangiopathy (TMA) following renal transplantation is a severe complication associated with high rates of allograft failure. Several immunosuppressive agents are associated with TMA. Conventional approaches to managing this entity, such as withdrawal of the offending agent and/or plasmapheresis, often offer limited help, with high rates of treatment failure and graft loss. We herein report a case of drug induced de novo TMA successfully treated using the C5a inhibitor eculizumab in a renal transplant patient. This report highlights a potentially important role for eculizumab in settings where drug-induced de novo TMA is refractory to conventional therapies.

Responsivity to food stimuli in obese and lean binge eaters using functional MRI.

Functional neuroimaging was employed to study 10 obese and 10 lean healthy young right-handed women, divided equally into binge and non-binge eaters. Subjects were presented with visual and auditory stimuli of binge type foods, non-binge type foods, and non-food stimuli in the fMRI scanner. Brain areas activated by both the visual and auditory stimuli across all individual subjects within a particular group was observed only for the binge food stimuli in the obese binge eaters, in the right premotor area, involved in planning of motor behavior. For four of the five obese binge eaters, the activation was in the ventral premotor cortex adjacent to the oral region, and may reflect past or concurrent motor planning about eating binge foods. Because a random effects group analysis has not yet been completed, this should be considered a preliminary report.