The impact of surgical volume on hospital ranking using the standardized infection ratio.

The Centers for Medicare and Medicaid Services require hospitals to report on quality metrics which are used to financially penalize those that perform in the lowest quartile. Surgical site infections (SSIs) are a critical component of the quality metrics that target healthcare-associated infections. However, the accuracy of such hospital profiling is highly affected by small surgical volumes which lead to a large amount of uncertainty in estimating standardized hospital-specific infection rates. Currently, hospitals with less than one expected SSI are excluded from rankings, but the effectiveness of this exclusion criterion is unknown. Tools that can quantify the classification accuracy and can determine the minimal surgical volume required for a desired level of accuracy are lacking. We investigate the effect of surgical volume on the accuracy of identifying poorly performing hospitals based on the standardized infection ratio and develop simulation-based algorithms for quantifying the classification accuracy. We apply our proposed method to data from HCA Healthcare (2014-2016) on SSIs in colon surgery patients. We estimate that for a procedure like colon surgery with an overall SSI rate of 3%, to rank hospitals in the HCA colon SSI dataset, hospitals that perform less than 200 procedures have a greater than 10% chance of being incorrectly assigned to the worst performing quartile. Minimum surgical volumes and predicted events criteria are required to make evaluating hospitals reliable, and these criteria vary by overall prevalence and between-hospital variability.

A COVID-19-ready public health surveillance system: The Food and Drug Administration's Sentinel System.

The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post-market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID-19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID-19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data. Early in the pandemic, Sentinel developed a multi-pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID-19, validated a diagnosis-code based algorithm for identifying patients with COVID-19 in administrative claims data, and coordinated with other national and international initiatives. Sentinel is poised to answer important questions about the natural history of COVID-19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID-19 prevention and treatment.

Ex Vivo Porcine Model for Robot-Assisted Partial Nephrectomy Simulation at a High-Volume Tertiary Center: Resident Perception and Validation Assessment Using the Global Evaluative Assessment of Robotic Skills Tool.

Introduction: With increased demands on surgeon productivity and outcomes, residency robotics training increasingly relies on simulations. The objective of this study is to assess the validity and effectiveness of an ex vivo porcine training model as a useful tool to improve surgical skill and confidence with robot-assisted partial nephrectomy (RAPN) among urology residents. Methods: A 2.5 cm circular area of ex vivo porcine kidneys was marked as the area of the tumor. Tumor excision and renorrhaphy was performed by trainees using a da Vinci Si robot. All residents ranging from postgraduate year (PGY) 2 to 5 participated in four training sessions during the 2017 to 2018 academic year. Each session was videorecorded and scored using the global evaluative assessment of robotic skills (GEARS) by faculty members. Results: Twelve residents completed the program. Initial mean GEARS score was 16.7 and improved by +1.4 with each subsequent session (p = 0.008). Initial mean excision, renorrhaphy, and total times were 8.2, 13.9, and 22.1 minutes, which improved by 1.6, 2.0, and 3.6 minutes, respectively (all p < 0.001). Residents' confidence at performing RAPN and robotic surgery increased after completing the courses (p = 0.012 and p < 0.001, respectively). Overall, residents rated that this program has greatly contributed to their skill (4/5) and confidence (4.1/5) in robotic surgery. Conclusions: An ex vivo porcine simulation model for RAPN and robotic surgery provides measurable improvement in GEARS score and reduction in procedural time, although significant differences for all PGY levels need to be confirmed with larger study participation. Adoption of this simulation in a urology residency curriculum may improve residents' skill and confidence in robotic surgery.

Effects Of A Communication-And-Resolution Program On Hospitals' Malpractice Claims And Costs.

To promote communication with patients after medical injuries and improve patient safety, numerous hospitals have implemented communication-and-resolution programs (CRPs). Through these programs, hospitals communicate transparently with patients after adverse events; investigate what happened and offer an explanation; and, when warranted, apologize, take responsibility, and proactively offer compensation. Despite growing consensus that CRPs are the right thing to do, concerns over liability risks remain. We evaluated the liability effects of CRP implementation at four Massachusetts hospitals by examining before-and-after trends in claims volume, cost, and time to resolution and comparing them to trends among nonimplementing peer institutions. CRP implementation was associated with improved trends in the rate of new claims and legal defense costs at some hospitals, but it did not significantly alter trends in other outcomes. None of the hospitals experienced worsening liability trends after CRP implementation, which suggests that transparency, apology, and proactive compensation can be pursued without adverse financial consequences.

A Road Map for Advancing the Practice of Respect in Health Care: The Results of an Interdisciplinary Modified Delphi Consensus Study.

BACKGROUND: Most health care organizations' efforts to reduce harm focus on physical harm, but other forms of harm are both prevalent and important. These "nonphysical" harms can be framed using the concepts of respect and dignity: Disrespect is an affront to dignity and can cause harm. Organizations should strive to eliminate disrespect to patients, to families, and among health care professionals. METHODS: A diverse, interdisciplinary panel of experts was convened to discuss strategies to guide health care systems to embrace an expanded definition of patient harm that includes nonphysical harm. Subsequently, using a modified Delphi process, a guide was developed for health care professionals and organizations to improve the practice of respect across the continuum of care. RESULTS: Five rounds of surveys were required to reach predefined metrics of consensus. Delphi participants identified a total of 25 strategies associated with six high-level recommendations: "Leaders must champion a culture of respect and dignity"; with other professionals sharing the responsibility to "Promote accountability"; "Engage and support the health care workforce"; "Partner with patients and families"; "Establish systems to learn about and improve the practice of respect"; and "Expand the research agenda and measurement tools, and disseminate what is learned." CONCLUSION: Harm from disrespect is the next frontier in preventable harm. This consensus statement provides a road map for health care organizations and professionals interested in engaging in a reliable practice of respect. Further work is needed to develop the specific tactics that will lead health care organizations to prevent harm from disrespect.

Outcomes In Two Massachusetts Hospital Systems Give Reason For Optimism About Communication-And-Resolution Programs.

Through communication-and-resolution programs, hospitals and liability insurers communicate with patients when adverse events occur; investigate and explain what happened; and, where appropriate, apologize and proactively offer compensation. Using data recorded by program staff members and from surveys of involved clinicians, we examined case outcomes of a program used by two academic medical centers and two of their community hospitals in Massachusetts in the period 2013-15. The hospitals demonstrated good adherence to the program protocol. Ninety-one percent of the program events did not meet compensation eligibility criteria, and those events that did were not costly to resolve (the median payment was $75,000). Only 5 percent of events led to malpractice claims or lawsuits. Clinicians were supportive of the program but desired better communication about it from staff members. Our findings suggest that communication-and-resolution programs will not lead to higher liability costs when hospitals adhere to their commitment to offer compensation proactively.

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.

Development and validation of the PROcedural Sedation Assessment Survey (PROSAS) for assessment of procedural sedation quality.

BACKGROUND: More than 20 million invasive procedures are performed annually in the United States. The vast majority are performed with moderate sedation or deep sedation, yet there is limited understanding of the drivers of sedation quality and patient satisfaction. Currently, the major gap in quality assurance for invasive procedures is the lack of procedural sedation quality measures. OBJECTIVE: To develop and validate a robust, patient-centered measure of procedural sedation quality, the PROcedural Sedation Assessment Survey (PROSAS). DESIGN: Through a series of interviews with patients, proceduralists, nurses, anesthesiologists, and an interactive patient focus group, major domains influencing procedural sedation quality were used to create a multipart survey. The pilot survey was administered and revised in sequential cohorts of adults receiving moderate sedation for GI endoscopy. After revision, the PROSAS was administered to a validation cohort. SETTING: GI endoscopy unit. PATIENTS: A expert panel of proceduralists, nurses, and anesthesiologists, an initial survey development cohort of 40 patients, and a validation cohort of 858 patients undergoing sedation for outpatient GI endoscopy with additional surveys completed by the gastroenterologist, procedure nurse, and recovery nurse. MAIN OUTCOMES AND MEASUREMENTS: Survey characteristics of the PROSAS. RESULTS: Patients were able to independently complete the PROSAS after procedural sedation before discharge. Of the patients, 91.6% reported minimal discomfort; however, 8.4% of patients reported significant discomfort and 2.4% of patients experienced hemodynamic and/or respiratory instability. There was a high correlation between patient-reported intraprocedure discomfort and both clinician assessments of procedural discomfort and patient recall of procedural pain 24 to 48 hours post procedure (P < .001 for all), suggesting high external validity. LIMITATIONS: Single-center study, variability of sedation technique between providers, inclusion of patients with chronic pain taking analgesics. CONCLUSIONS: The PROSAS is a clinically relevant, patient-centered, easily administered instrument that allows for standardized evaluation of procedural sedation quality. The PROSAS may be useful in both research and clinical settings.

Enhanced identification of postoperative infections among outpatients.

We investigated using administrative claims data to identify surgical site infections (SSI) after breast surgery and cesarean section. Postoperative diagnosis codes, procedure codes, and pharmacy information were automatically scanned and used to identify claims suggestive of SSI ("indicators") among 426 (22%) of 1,943 breast procedures and 474 (10%) of 4,859 cesarean sections. For 104 breast procedures with indicators explained in available medical records, SSI were confirmed for 37%, and some infection criteria were present for another 27%. Among 204 cesarean sections, SSI were confirmed for 40%, and some criteria were met for 27%. The extrapolated infection rates of 2.8% for breast procedures and 3.1% for cesarean section were similar to those reported by the National Nosocomial Infection Surveillance program but differ in representing predominantly outpatient infections. Claims data may complement other data sources for identification of surgical site infections following breast surgery and cesarean section.

Relationship of pulmonary artery catheter use to mortality and resource utilization in patients with severe sepsis.

OBJECTIVE: To examine the relationship of pulmonary artery catheter (PAC) use to patient outcomes, including mortality rate and resource utilization, in patients with severe sepsis in eight academic medical centers. DESIGN: Case-control, nested within a prospective cohort study. SETTING: Eight academic tertiary care centers. PATIENTS: Stratified random sample of 1,010 adult admissions with severe sepsis. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The main outcome measures were in-hospital mortality, total hospital charge, and length of stay (LOS) for patients with and without PAC use. The case-matched subset of patients included 141 pairs managed with and without the use of a PAC. The mortality rate was slightly but not statistically significantly lower among the PAC use group compared with those not using a PAC (41.1% vs. 46.8%, p =.34). Even this trend disappeared after we adjusted for the Charlson comorbidity score and sepsis-specific Acute Physiology and Chronic Health Evaluation (APACHE) III (adjusted odds ratio, 1.02; 95% confidence interval, 0.61-1.72). In linear regression models adjusted for the Charlson comorbidity score, sepsis-specific APACHE III, surgical status, receipt of a steroid before sepsis onset, presence of a Hickman catheter, and preonset LOS, no significant differences were found for total hospital charges (139,207 US dollars vs. 148,190, adjusted mean comparing PAC and non-PAC group, p =.57), postonset LOS (23.4 vs. 26.9 days, adjusted mean, p =.32), or total LOS in intensive care unit (18.2 vs. 18.8 days, adjusted mean, p =.82). CONCLUSIONS: Among patients with severe sepsis, PAC placement was not associated with a change in mortality rate or resource utilization, although small nonsignificant trends toward lower resource utilization were present in the PAC group.

Severe sepsis: variation in resource and therapeutic modality use among academic centers.

BACKGROUND: Treatment of severe sepsis is expensive, often encompassing a number of discretionary modalities. The objective of the present study was to assess intercenter variation in resource and therapeutic modality use in patients with severe sepsis. METHODS: We conducted a prospective cohort study of 1028 adult admissions with severe sepsis from a stratified random sample of patients admitted to eight academic tertiary care centers. The main outcome measures were length of stay (LOS; total LOS and LOS after onset of severe sepsis) and total hospital charges. RESULTS: The adjusted mean total hospital charges varied from 69 429 dollars to US237 898 dollars across centers, whereas the adjusted LOS after onset varied from 15.9 days to 24.2 days per admission. Treatments used frequently after the first onset of sepsis among patients with severe sepsis were pulmonary artery catheters (19.4%), ventilator support (21.8%), pressor support (45.8%) and albumin infusion (14.4%). Pulmonary artery catheter use, ventilator support and albumin infusion had moderate variation profiles, varying 3.2-fold to 4.9-fold, whereas the rate of pressor support varied only 1.92-fold across centers. Even after adjusting for age, sex, Charlson comorbidity score, discharge diagnosis-relative group weight, organ dysfunction and service at onset, the odds for using these therapeutic modalities still varied significantly across centers. Failure to start antibiotics within 24 hours was strongly correlated with a higher probability of 28-day mortality (r2 = 0.72). CONCLUSION: These data demonstrate moderate but significant variation in resource use and use of technologies in treatment of severe sepsis among academic centers. Delay in antibiotic therapy was associated with worse outcome at the center level.

Health and economic impact of surgical site infections diagnosed after hospital discharge.

Although surgical site infections (SSIs) are known to cause substantial illness and costs during the index hospitalization, little information exists about the impact of infections diagnosed after discharge, which constitute the majority of SSIs. In this study, using patient questionnaire and administrative databases, we assessed the clinical outcomes and resource utilization in the 8-week postoperative period associated with SSIs recognized after discharge. SSI recognized after discharge was confirmed in 89 (1.9%) of 4,571 procedures from May 1997 to October 1998. Patients with SSI, but not controls, had a significant decline in SF-12 (Medical Outcomes Study 12-Item Short-Form Health Survey) mental health component scores after surgery (p=0.004). Patients required significantly more outpatient visits, emergency room visits, radiology services, readmissions, and home health aide services than did controls. Average total costs during the 8 weeks after discharge were US dollars 5,155 for patients with SSI and US dollars 1,773 for controls (p<0.001).

Resource utilization among patients with sepsis syndrome.

OBJECTIVE: To assess the resource utilization associated with sepsis syndrome in academic medical centers. DESIGN: Prospective cohort study. SETTING: Eight academic, tertiary-care centers. PATIENTS: Stratified random sample of 1,028 adult admissions with sepsis syndrome and all 248,761 other adult admissions between January 1993 and April 1994. The main outcome measures were length of stay (LOS) in total and after onset of sepsis syndrome (post-onset LOS) and total hospital charges. RESULTS: The mean LOS for patients with sepsis was 27.7 +/- 0.9 days (median, 20 days), with sepsis onset occurring after a mean of 8.1 +/- 0.4 days (median, 3 days). For all patients without sepsis, the LOS was 7.2 +/- 0.03 days (median, 4 days). In multiple linear regression models, the mean for patients with sepsis syndrome was 18.2 days, which was 11.0 days longer than the mean for all other patients (P < .0001), whereas the mean difference in total charges was $43,000 (both P < .0001). These differences were greater for patients with nosocomial as compared with community-acquired sepsis, although the groups were similar after adjusting for pre-onset LOS. Eight independent correlates of increased post-onset LOS and 12 correlates of total charges were identified. CONCLUSIONS: These data quantify the resource utilization associated with sepsis syndrome, and demonstrate that resource utilization is high in this group. Additional investigation is required to determine how much of the excess post-onset LOS and charges are attributable to sepsis syndrome rather than the underlying medical conditions.

Binary cumulative sums and moving averages in nosocomial infection cluster detection.

Clusters of nosocomial infection often occur undetected, at substantial cost to the medical system and individual patients. We evaluated binary cumulative sum (CUSUM) and moving average (MA) control charts for automated detection of nosocomial clusters. We selected two outbreaks with genotyped strains and used resistance as inputs to the control charts. We identified design parameters for the CUSUM and MA (window size, k, alpha, Beta, p(0), p(1)) that detected both outbreaks, then calculated an associated positive predictive value (PPV) and time until detection (TUD) for sensitive charts. For CUSUM, optimal performance (high PPV, low TUD, fully sensitive) was for 0.1 < or = alpha < or = 0.25 and 0.2 < or = Beta < or = 0.25, with p(0) = 0.05, with a mean TUD of 20 (range 8-43) isolates. Mean PPV was 96.5% (relaxed criteria) to 82.6% (strict criteria). MAs had a mean PPV of 88.5% (relaxed criteria) to 46.1% (strict criteria). CUSUM and MA may be useful techniques for automated surveillance of resistant infections.

Using automated health plan data to assess infection risk from coronary artery bypass surgery.

We determined if infection indicators were sufficiently consistent across health plans to allow comparison of hospitals' risks of infection after coronary artery bypass surgery. Three managed care organizations accounted for 90% of managed care in eastern Massachusetts, from October 1996 through March 1999. We searched their automated inpatient and outpatient claims and outpatient pharmacy dispensing files for indicator codes suggestive of postoperative surgical site infection. We reviewed full text medical records of patients with indicator codes to confirm infection status. We compared the hospital-specific proportions of cases with an indicator code, adjusting for health plan, age, sex, and chronic disease score. A total of 536 (27%) of 1,953 patients had infection indicators. Infection was confirmed in 79 (53%) of 149 reviewed records with adequate documentation. The proportion of patients with an indicator of infection varied significantly (p < 0.001) between hospitals (19% to 36%) and health plans (22% to 33%). The difference between hospitals persisted after adjustment for health plan and patients' age and sex. Similar relationships were observed when postoperative antibiotic information was ignored. Automated claims and pharmacy data from different health plans can be used together to allow inexpensive, routine monitoring of indicators of postoperative infection, with the goal of identifying institutions that can be further evaluated to determine if risks for infection can be reduced.