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.).

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.

Assessment of Claimant, Clinical, and Financial Characteristics of Teleradiology Medical Malpractice Cases.

Background The increasing use of teleradiology has been accompanied by concerns relating to risk management and patient safety. Purpose To compare characteristics of teleradiology and nonteleradiology radiology malpractice cases and identify contributing factors underlying these cases. Materials and Methods In this retrospective analysis, a national database of medical malpractice cases was queried to identify cases involving telemedicine that closed between January 2010 and March 2022. Teleradiology malpractice cases were identified based on manual review of cases in which telemedicine was coded as one of the contributing factors. These cases were compared with nonteleradiology cases that closed during the same time period in which radiology had been determined to be the primary responsible clinical service. Claimant, clinical, and financial characteristics of the cases were recorded, and continuous or categorical data were compared using the Wilcoxon rank-sum test or Fisher exact test, respectively. Results This study included 135 teleradiology and 3474 radiology malpractices cases. The death of a patient occurred more frequently in teleradiology cases (48 of 135 [35.6%]) than in radiology cases (685 of 3474 [19.7%]; P < .001). Cerebrovascular disease was a more common final diagnosis in the teleradiology cases (13 of 135 [9.6%]) compared with the radiology cases (124 of 3474 [3.6%]; P = .002). Problems with communication among providers was a more frequent contributing factor in the teleradiology cases (35 of 135 [25.9%]) than in the radiology cases (439 of 3474 [12.6%]; P < .001). Teleradiology cases were more likely to close with indemnity payment (79 of 135 [58.5%]) than the radiology cases (1416 of 3474 [40.8%]; P < .001) and had a higher median indemnity payment than the radiology cases ($339 230 [IQR, $120 790-$731 615] vs $214 063 [IQR, $66 620-$585 424]; P = .01). Conclusion Compared with radiology cases, teleradiology cases had higher clinical and financial severity and were more likely to involve issues with communication. © RSNA, 2024 See also the editorial by Mezrich in this issue.

Multisource Evaluation of Surgeon Behavior Is Associated With Malpractice Claims.

OBJECTIVE: We merged direct, multisource, and systematic assessments of surgeon behavior with malpractice claims, to analyze the relationship between surgeon 360-degree reviews and malpractice history. BACKGROUND: Previous work suggests that malpractice claims are associated with a poor physician-patient relationship, which is likely related to behaviors captured by 360-degree review. We hypothesize that 360-degree review results are associated with malpractice claims. METHODS: Surgeons from 4 academic medical centers covered by a common malpractice carrier underwent 360-degree review in 2012 to 2013 (n = 385). Matched, de-identified reviews and malpractice claims data were available for 264 surgeons from 2000 to 2015. We analyzed 23 questions, highlighting positive and negative behaviors within the domains of education, excellence, humility, openness, respect, service, and teamwork. Regression analysis with robust standard error was used to assess the potential association between 360-degree review results and malpractice claims. RESULTS: The range of claims among the 264 surgeons was 0 to 8, with 48.1% of surgeons having at least 1 claim. Multiple positive and negative behaviors were significantly associated with the risk of having malpractice claims (P < 0.05). Surgeons in the bottom decile for several items had an increased likelihood of having at least 1 claim. CONCLUSION: Surgeon behavior, as assessed by 360-degree review, is associated with malpractice claims. These findings highlight the importance of teamwork and communication in exposure to malpractice. Although the nature of malpractice claims is complex and multifactorial, the identification and modification of negative physician behaviors may mitigate malpractice risk and ultimately result in the improved quality of patient care.

A retrospective review of medical errors adjudicated in court between 2002 and 2012 in Spain.

OBJECTIVES: This paper describes verdicts in court involving injury-producing medical errors in Spain. DESIGN, SETTING AND PARTICIPANTS: A descriptive analysis of 1041 closed court verdicts from Spain between January 2002 and December 2012. It was determined whether a medical error had occurred, and among those with medical error (n = 270), characteristics and results of litigation were analyzed. Data on litigation were obtained from the Thomson Reuters Aranzadi Westlaw databases. MAIN OUTCOME MEASURES: All verdicts involving health system were reviewed and classified according to the presence of medical error. Among those, contributory factors, medical specialty involved, health impact (death, disability and severity) and results of litigation (resolution, time to verdict and economic compensations) were described. RESULTS: Medical errors were involved in 25.9% of court verdicts. The cause of medical error was a diagnosis-related problem in 25.1% and surgical treatment in 22.2%, and Obstetrics-Gynecology was the most frequent involved specialty (21%). Most of them were of high severity (59.4%), one-third (32%) caused death. The average time interval between the occurrence of the error and the verdict was 7.8 years. The average indemnity payment was €239 505.24; the highest was psychiatry (€7 585 075.86) and the lowest was Emergency Medicine (€69 871.19). CONCLUSIONS: This study indicates that in Spain medical errors are common among verdicts involving the health system, most of them causing high-severity adverse outcomes. The interval between the medical error and the verdict is excessive, and there is a wide range of economic compensation.

Four-year impact of an alert notification system on closed-loop communication of critical test results.

OBJECTIVE: One of the patient safety goals proposed by the Joint Commission urges hospitals to develop a policy for communicating critical test results and to measure adherence to that policy. We evaluated the impact of an alert notification system on policy adherence for communicating critical imaging test results to referring providers and assessed system adoption over the first 4 years after implementation. MATERIALS AND METHODS: This study was performed in a 753-bed academic medical center. The intervention, an automated alert notification system for critical results, was implemented in January 2010. The primary outcome was adherence to institutional policy for timely closed-loop communication of critical imaging results, and the secondary outcome was system adoption. Policy adherence was determined through manual review of a random sample of radiology reports from the first 4 years after the intervention (n = 37,604) compared with baseline outcomes 1 year before the intervention (n = 9430). Adoption was evaluated by quantifying the use of the system overall and the proportion of alerts that used noninterruptive communication as a percentage of all reports generated by 320 radiologists (n = 1,538,059). A statistical analysis of the trend at 6-month intervals over 4 years was performed using a chi-square trend test. RESULTS: Adherence to the policy increased from 91.3% before the intervention to 95.0% after the intervention (p < 0.0001). There was a ninefold increase in the critical results communicated via the system (chi-square trend test, p < 0.0001). During the first 4 years after the intervention, 41,445 alerts (41% of the total number of alerts) used the system's noninterruptive process for communicating less urgent critical results, which was substantially unchanged over the 4 years postintervention, thus reducing unnecessary paging interruptions. CONCLUSION: An automated alert notification system for communicating critical imaging results was successfully adopted and was associated with increased adherence to institutional policy for communicating critical test results and with reduced workflow interruptions.

Reducing the Risk of Delayed Colorectal Cancer Diagnoses Through an Ambulatory Safety Net Collaborative.

BACKGROUND: An estimated 12 million adults in the United States experience delayed diagnoses and other diagnostic errors annually. Ambulatory safety nets (ASNs) are an intervention to reduce delayed diagnoses by identifying patients with abnormal results overdue for follow-up using registries, workflow redesign, and patient navigation. The authors sought to co-design a collaborative and implement colorectal cancer (CRC) ASNs across various health care settings. METHODS: A working group was convened to co-design implementation guidance, measures, and the collaborative model. Collaborative sites were recruited through a medical professional liability insurance program and chose to begin with developing an ASN for positive at-home CRC screening or overdue surveillance colonoscopy. The 18-month Breakthrough Series Collaborative ran from January 2022 to July 2023, with sites continuing to collect data while sustaining their ASNs. Data were collected from sites monthly on patients in the ASN, including the proportion that was successfully contacted, scheduled, and completed a follow-up colonoscopy. RESULTS: Six sites participated; four had an operational ASN at the end of the Breakthrough Series, with the remaining sites launching three months later. From October 2022 through February 2024, the Collaborative ASNs collectively identified 5,165 patients from the registry as needing outreach. Among patients needing outreach, 3,555 (68.8%) were successfully contacted, 2,060 (39.9%) were scheduled for a colonoscopy, and 1,504 (29.1%) completed their colonoscopy. CONCLUSION: The Collaborative successfully identified patients with previously abnormal CRC screening and facilitated completion of follow-up testing. The CRC ASN Implementation Guide offers a comprehensive road map for health care leaders interested in implementing CRC ASNs.

The Effect of Clinical Volume on Annual and Per-Patient Encounter Medical Malpractice Claims Risk.

OBJECTIVES: The relationship between medical malpractice risk and one of the fundamental characteristics of physician practice, clinical volume, remains undefined. This study examined how the annual and per-patient encounter medical malpractice claims risk varies with clinical volume. METHODS: Clinical volume was determined using health insurance charges and was linked at the physician level to malpractice claims data from a malpractice insurer. The annual medical malpractice claims risk was expressed as the percent of physicians with a malpractice claim, and the per-encounter medical malpractice claims risk was expressed as malpractice claims per 1000 patient encounters. Both of these malpractice claims risk metrics were analyzed as a function of clinical volume, using linear and spline regression. RESULTS: As clinical volume increased, the percent of physicians with a malpractice claim increased linearly. Among all physicians studied, for each decile increase in clinical volume, there was a 0.373% increase in physicians with a malpractice claim (95% confidence interval, 0.301%-0.446%; P < 0.0001). As clinical volume increased, the rate of malpractice claims per 1000 patient encounters decreased. This relationship between clinical volume and per-encounter claims risk was nonlinear. There was a clinical volume threshold, below which decreasing clinical volume was associated with increasing per-encounter claims risk, and above which claims risk no longer significantly varied with increases in clinical volume. CONCLUSIONS: Clinical volume is a crucial determinant of physician malpractice risk, with higher-volume physicians having higher annual risk but lower per-encounter risk. Clinical volume data should be incorporated into analyses of malpractice risk.

Association of Simulation Training With Rates of Medical Malpractice Claims Among Obstetrician-Gynecologists.

OBJECTIVE: To compare malpractice claim rates before and after participation in simulation training, which focused on team training during a high-acuity clinical case. METHODS: We performed a retrospective analysis comparing the claim rates before and after simulation training among 292 obstetrician-gynecologists, all of whom were insured by the same malpractice insurer, who attended one or more simulation training sessions from 2002 to 2019. The insurer provided malpractice claims data involving study physicians, along with durations of coverage, which we used to calculate claim rates, expressed as claims per 100 physician coverage years. We used three different time periods in our presimulation and postsimulation training claim rates comparisons: the entire study period, 2 years presimulation and postsimulation training, and 1 year presimulation and postsimulation training. Secondary outcomes included indemnity payment amounts, percent of claims paid, and injury severity. RESULTS: Compared with presimulation training, malpractice claim rates were significantly lower postsimulation training for the full study period (11.2 vs 5.7 claims per 100 physician coverage years; P<.001) and the 2 years presimulation and postsimulation training (9.2 vs 5.4 claims per 100 physician coverage years; P=.043). For the 1 year presimulation and postsimulation training comparison, the decrease in claim rates was nonsignificant (8.8 vs 5.3 claims per 100 physician coverage years; P=.162). Attending more than one simulation session was associated with a greater reduction in claim rates. Postsimulation claim rates for physicians who attended one, two, or three or more simulation sessions were 6.3, 2.1, and 1.3 claims per 100 physician coverage years, respectively (P<.001). Compared with presimulation training, there was no significant difference in the median or mean indemnity paid, percent of claims on which an indemnity payment was made, or median severity of injury after simulation training. CONCLUSION: We observed a significant reduction in malpractice claim rates after simulation training. Wider use of simulation training within obstetrics and gynecology should be considered.

Patient Engagement Activities and Patient Experience: Are Patients With a History of Depression the Canary in the Coal Mine?

Little is known about the effectiveness of primary care practices' efforts to engage patients in their health and health care. We examine the association between patient engagement efforts and patients' experiences of care. We found no association between an unweighted count of patient engagement activities and patient experience. Compared with the bottom quartile of practices, however, the top quartile had better performance on patient experience domains of communication, front-office staff, and organizational access (out of nine domains). Furthermore, patients reporting a diagnosis of depression have higher ratings across five domains of patient experience when in practices with higher levels of patient engagement activities measured using an unweighted scale. Future research is needed to understand how the benefits of patient engagement activities can accrue to more patient subgroups. These promising results suggest that payers and policy makers should continue to support implementation and benchmarking of patient engagement efforts across practices.

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.

Integrating incident data from five reporting systems to assess patient safety: making sense of the elephant.

BACKGROUND: A study was conducted to examine and compare information gleaned from five different reporting systems within one institution: incident reporting, patient complaints, risk management, medical malpractice claims, and executive walk rounds. These data sources vary in the timing of the reporting (retrospective or prospective), severity of the events, and profession of the reporters. METHODS: A common methodology was developed for classifying incidents. Data specific to each incident were abstracted from each system and then categorized using the same framework into one of 23 categories. RESULTS: Overall, there was little overlap, although each reporting system identified important safety issues. Communication problems were common among patient complaints and malpractice claims; malpractice claims' leading category was clinical judgement. Walk rounds identified issues with equipment and supplies. Adverse event reporting systems highlighted identification issues, especially mislabelled specimens. The frequency of contributions of reports by provider group varied substantially by system. Physicians accounted for 50% of risk management reports, but in adverse event reporting, where nurses were the main reporters, physicians accounted for only 2.5% of reports. Complaints and malpractice claims come primarily from patients. CONCLUSIONS: The five reporting systems each identified different yet complementary patient safety issues. To obtain a comprehensive picture of their patient safety problems and to develop priorities for improving safety, hospitals should use a broad portfolio of approaches and then synthesize the messages from all individual approaches into a collated and cohesive whole.

The Impact of Incident Disclosure Behaviors on Medical Malpractice Claims.

OBJECTIVES: To provide preliminary estimates of incident disclosure behaviors on medical malpractice claims. METHODS: We conducted a descriptive analysis of data on medical malpractice claims obtained from the Controlled Risk Insurance Company and Risk Management Foundation of Harvard Medical Institutions (Cambridge, Massachusetts) between 2012 and 2013 (n = 434). The characteristics of disclosure and apology after medical errors were analyzed. RESULTS: Of 434 medical malpractice claims, 4.6% (n = 20) medical errors had been disclosed to the patient at the time of the error, and 5.9% (n = 26) had been followed by disclosure and apology. The highest number of disclosed injuries occurred in 2011 (23.9%; n = 11) and 2012 (34.8%; n = 16). There was no incremental increase during the financial years studied (2012-2013). The mean age of informed patients was 52.96 years, 58.7 % of the patients were female, and 52.2% were inpatients. Of the disclosed errors, 26.1% led to an adverse reaction, and 17.4% were fatal. The cause of disclosed medical error was improper surgical performance in 17.4% (95% confidence interval, 6.4-28.4). Disclosed medical errors were classified as medium severity in 67.4%. No apology statement was issued in 54.5% of medical errors classified as high severity. CONCLUSIONS: At the health-care centers studied, when a claim followed a medical error, providers infrequently disclosed medical errors or apologized to the patient or relatives. Most of the medical errors followed by disclosure and apology were classified as being of high and medium severity. No changes were detected in the volume of lawsuits over time.

Safely Practicing in a New Environment: A Qualitative Study to Inform Physician Onboarding Practices.

BACKGROUND: Physicians are frequently asked to practice in hospitals different from their home institution, often under contracts called professional service agreements (PSAs). With highly variable onboarding processes, traveling physicians are often left to "figure out" the available resources, processes of care, crucial relationships, and culture of the new institution. This research aimed to understand the current practices of onboarding for the purpose of informing future improvements in practice. METHODS: Two physicians conducted semistructured, in-depth interviews with physicians working at hospitals beyond their home institution. A thematic qualitative analysis was performed. RESULTS: The sample included 20 physicians from six specialties. Key findings include (1) the basic logistics of providing care in a new environment are often not incorporated into physician onboarding and can limit physicians' ability to provide care efficiently and effectively; (2) the strength of interpersonal relationships greatly influences the ability of physicians to get help when working in new environments; and (3) managing clinical emergencies in unfamiliar settings can result in significant perceived risk to patient safety due to delays in providing care. CONCLUSION: The onboarding process, for physicians working in new institutions, provides significant opportunity for improvement. In the future, more work is needed to ensure that the most notable differences between institutions are clarified, physicians have the necessary information and professional relationships to handle emergencies, and they know which patients they can safely care for in their new institution.

Demonstrating the value of postgraduate fellowships for physicians in quality improvement and patient safety.

BACKGROUND: Academic fellowships in quality improvement (QI) and patient safety (PS) have emerged as one strategy to fill a need for physicians who possess this expertise. The authors aimed to characterise the impact of two such programmes on the graduates and their value to the institutions in which they are housed. METHODS: In 2018, a qualitative study of two US QIPS postgraduate fellowship programmes was conducted. Graduates' demographics and titles were collected from programme files,while perspectives of the graduates and their institutional mentors were collected through individual interviews and analysed using thematic analysis. RESULTS: Twenty-eight out of 31 graduates (90%) and 16 out of 17 (94%) mentors participated in the study across both institutions. At a median of 3 years (IQR 2-4) postgraduation, QIPS fellowship programme graduates' effort distribution was: 50% clinical care (IQR 30-61.8), 48% QIPS administration (IQR 20-60), 28% QIPS research (IQR 17.5-50) and 15% education (7.1-30.4). 68% of graduates were hired in the health system where they trained. Graduates described learning the requisite hard and soft skills to succeed in QIPS roles. Mentors described the impact of the programme on patient outcomes and increasing the acceptability of the field within academic medicine culture. CONCLUSION: Graduates from two QIPS fellowship programmes and their mentors perceive programmatic benefits related to individual career goal attainment and institutional impact. The results and conceptual framework presented here may be useful to other academic medical centres seeking to develop fellowships for advanced physician training programmes in QIPS.

Eleven-year descriptive analysis of closed court verdicts on medical errors in Spain and Massachusetts.

OBJECTIVES: To evaluate and compare the characteristics of court verdicts on medical errors allegedly harming patients in Spain and Massachusetts from 2002 to 2012. DESIGN, SETTING AND PARTICIPANTS: We reviewed 1041 closed court verdicts obtained from data on litigation in the Thomson Reuters Aranzadi Westlaw databases in Spain (Europe), and 370 closed court verdicts obtained from the Controlled Risk and Risk Management Foundation of Harvard Medical Institutions (CRICO/RMF) in Massachusetts (USA). We included closed court verdicts on medical errors. The definition of medical errors was based on that of the Institute of Medicine (USA). We excluded any agreements between parties before a judgement. RESULTS: Medical errors were involved in 25.9% of court verdicts in Spain and in 74% of those in Massachusetts. The most frequent cause of medical errors was a diagnosis-related problem (25.1%; 95% CI 20.7% to 31.1% in Spain; 35%; 95% CI 29.4% to 40.7% in Massachusetts). The proportion of medical errors classified as high severity was 34% higher in Spain than in Massachusetts (p=0.001). The most frequent factors contributing to medical errors in Spain were surgical and medical treatment (p=0.001). In Spain, 98.5% of medical errors resulted in compensation awards compared with only 6.9% in Massachusetts. CONCLUSIONS: This study reveals wide differences in litigation rates and the award of indemnity payments in Spain and Massachusetts; however, common features of both locations are the high rates of diagnosis-related problems and the long time interval until resolution.

Design and Implementation of the Harvard Fellowship in Patient Safety and Quality.

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.

Creating a Fellowship Curriculum in Patient Safety and Quality.

The authors sought to create a curriculum suitable for a newly created clinical fellowship curriculum across Harvard Medical School-affiliated teaching hospitals as part of a newly created 2-year quality and safety fellowship program described in the companion article "Design and Implementation of the Harvard Fellowship in Patient Safety and Quality." The aim of the curriculum development process was to define, coordinate, design, and implement a set of essential skills for future physician-scholars of any specialty to lead operational quality and patient safety efforts. The process of curriculum development and the ultimate content are described in this article.