Using Process Flow Disruption Analysis to Guide Quality Improvement.

BACKGROUND: Process flow describes the efficiency and consistency with which a process functions. Disruptions in surgical flow have been shown to be associated with an increase in error. Despite this, little experience exists in using surgical flow analysis to guide quality improvement (QI). STUDY DESIGN: In a 900-bed teaching hospital with an annual surgical volume of 24,000 cases, a 4-month observational study of process flow was done by experts in complex system evaluation. Identified flow disruptions were used to guide QI. Statistical analysis included descriptive and bivariate techniques. RESULTS: More than 200 unique process data points were evaluated. There was a high degree of variability in completion of 79 individual intraoperative data elements. Lack of completion of all elements of the time out was associated with number of times the operating room door opened during case (19, 11-27; p = 0.01). Flow disruptions were used to direct surgical QI. One example was a disruption affecting the use of Sugammadex. Resolving this flow disruption resulted in a 59% reduction in the incidence of postoperative respiratory failure (p < 0.01) and a direct and variable cost savings of $447,200 and $313,160, respectively, in the first 12 months. CONCLUSIONS: The use of process flow analysis to direct surgical quality initiatives is a novel approach that emphasizes system-level strategy. Resolving flow disruptions can lead to effective QI that embraces reliability by focusing attention on common processes rather than adverse events that may be unique and therefore difficult to apply broadly.

Applying international organization for standards 9001 to create an effective surgical quality committee.

BACKGROUND: Efforts to improve surgical safety are limited by several factors and no consensus exists regarding the most effective way to improve surgical quality. The use of ISO 9001 quality standards within healthcare is recognized but has not been widely applied for improving surgical outcomes. METHODS: A surgical quality committee was created using ISO 9001:2015 standards. Quality objectives were assessed to understand how any suggested changes will be impacted due to risks and opportunities inherent in the system. RESULTS: The initial quality focus was on surgical site infections in 5 services. Change in surgical infection ratio from 2018 to 2019 showed significant improvement: coronary bypass 1.288 vs. 0.901; Colon 1.359 vs. 0.589; Hysterectomy 2.119 vs. 1.022; Knee 1.391 vs. 0.306; Hip 0 vs. 0.302. CONCLUSIONS: This is one of the first studies using ISO 9001 to improve surgical quality. The results indicate both acceptance and success of applying continual improvement strategies.

ECMO During Combined Heart-Kidney Transplantation: A Case Report.

Combined heart-kidney transplantation (CHKT) is a therapy for a carefully selected subgroup of patients with concomitant heart and kidney failure. Discerning whether there is reversible or irreversible kidney disease is crucial to selection for CHKT versus heart transplant alone to optimize therapeutic value and organ allocation. Methods for determining extent of kidney disease include estimating glomerular filtration rate, creatinine clearance, kidney ultrasonography, and kidney biopsy. Additionally, the use of extracorporeal membrane oxygenation (ECMO) in the setting of CHKT only recently emerged as feasible. We present a case of a 69-year-old man with cardiogenic shock who was placed on venoarterial-ECMO (VA-ECMO) following orthotopic heart transplant (OHT) due to severe mediastinal bleeding and remained on VA-ECMO during kidney transplant. To our knowledge, this is the second report of a patient undergoing kidney transplant while on VA-ECMO following OHT.

The Change in Surgical Case Diversity Over the Past 15 Years and the Influence on the Pursuit of Surgical Fellowship.

The surgical community has expressed concern that residents do not receive the same caliber training as their predecessors and the increase in fellowships have been described as secondary to perceived lack of preparation. Yet, data show no change in total cases even after implementation of the 80-hour workweek. It is hypothesized that the increasing subspecialization of general surgery may decrease in certain resident case numbers. Data were collected from the Accreditation Council for Graduate Medical Education (ACGME) General Surgery Case Logs National Data Report (1999-2014) of mean number of procedures per resident for 19 surgical categories. Statistical analysis was performed with analysis of variance over three time periods between 1999 and 2014. The number of total cases performed by residents has not changed significantly. There was a statistically significant difference observed in the variety of cases: vascular, esophageal, breast, and trauma cases decreased (P < 0.01), whereas major intestinal, hernia, liver, pancreatic, and biliary cases increased (P < 0.01). There are many reasons to pursue additional training after residency. The demonstrated change in case variability, presumably secondary to increasing fellowships, may play a significant role on training and preparation. Close monitoring of curriculums is essential to ensure a comprehensive general surgical education.

Factors leading to pancreatic resection in patients with pancreatic cancer: a national perspective.

BACKGROUND: Resection is the only option for potential cure in pancreatic cancer. Patients admitted for resection may have the procedure deferred during their hospitalization. We aim to identify factors that lead pancreatic cancer patients to undergo resection. METHODS: An analysis utilizing the Nationwide Inpatient Sample (NIS) database, 2003-2009. Study population included adults (≥18 years) with pancreatic cancer who underwent either pancreatic resection or other interventions. Surgeon volume classified based on the median into low and high-volume surgeon. RESULTS: Eleven thousand three hundred and sixty-five patients were included; 68.0% underwent pancreatic resection, while 32.0% had other interventions. The majority of patients resected were <60 years old, female, with higher annual household income (P<0.05 for all). Patients with Medicaid coverage and comorbidity scores ≥2 were least likely to undergo pancreatic resection. Resection was more likely for high-volume surgeons, high-volume hospitals and teaching hospitals (P<0.05 for all). Those managed by high-volume surgeons were at a lower risk of postoperative complications, lower mortality, shorter hospital stay, and lower healthcare costs (P<0.05 for all). CONCLUSIONS: Patients' insurance type and economic status are significantly associated with their ability to achieve pancreatic resection. Surgeon experience and hospital volumes were also significantly associated with pancreatic resection, clinical and economic outcomes.

Choosing Surgery: Identifying Factors Leading to Increased General Surgery Matriculation Rate.

Tulane graduates have, over the past six years, chosen general surgical residency at a rate above the national average (mean 9.6% vs 6.6%). With much of the recent career choice research focusing on disincentives and declining general surgery applicants, we sought to identify factors that positively influenced our students' decision to pursue general surgery. A 50-question survey was developed and distributed to graduates who matched into a general surgery between the years 2006 and 2014. The survey evaluated demographics, exposure to surgery, and factors affecting interest in a surgical career. We achieved a 54 per cent (61/112) response rate. Only 43 per cent considered a surgical career before medical school matriculation. Fifty-nine per cent had strongly considered a career other than surgery. Sixty-two per cent chose to pursue surgery during or immediately after their surgery clerkship. The most important factors cited for choosing general surgery were perceived career enjoyment of residents and faculty, resident/faculty relationship, and mentorship. Surgery residents and faculty were viewed as role models by 72 and 77 per cent of responders, respectively. This study demonstrated almost half of those choosing a surgical career did so as a direct result of the core rotation experience. We believe that structuring the medical student education experience to optimize the interaction of students, residents, and faculty produces a positive environment encouraging students to choose a general surgery career.

Risk of Intraoperative Injury of Nearby Structures: National Trend, Distribution, and Burden.

BACKGROUND: Accidental injury of a nearby structure during surgical operations carries a risk of serious morbidity and mortality. Furthermore, it represents a medico-legal liability. We aimed to examine the national distribution, cost, and trend of accidental intraoperative injuries. STUDY DESIGN: We performed a cross-sectional study using the Nationwide Inpatient Sample database. The study population consisted of patients who encountered intraoperative injuries between 2003 and 2010. Controls were randomly selected from patients who underwent similar procedures during the same period. Cost was adjusted for inflation rate to reflect 2015 dollar values. RESULTS: A total of 61,667 cases with intraoperative injuries and 430,424 controls were included. Intraoperative injuries were most common in procedures that involved the digestive system (38.0%), female reproductive organs (21.4%), and musculoskeletal system (12.2%). There was a significant increase in those injuries from 161.3 cases/100,000 procedures in 2003 to 254.9 cases/100,000 procedures in 2010 (p < 0.001). Female sex, pediatric and older populations, overweight, trauma and teaching hospital were all independent risk factors of injuries in the multivariate model (p < 0.05 for all). Intraoperative injuries were associated with a higher risk of concomitant complications (odds ratio [OR] 2.44, 95% CI 2.36, 2.54, p < 0.001) and hospital mortality risk (OR 2.33, 95% CI [2.15, 2.51], p < 0.001). Nationally, it is estimated that injuries of nearby structures resulted in an annual average of 84,708.7 days of excess hospital admission days and $426.33 million excess cost. CONCLUSIONS: Certain demographic and clinical factors influence the risk of intraoperative injury of nearby structures. The prevalence of intraoperative injuries is increasing at the national level, and these injuries are associated with increased mortality and pose substantial clinical and financial burdens.

The impact of statins on biological characteristics of stem cells provides a novel explanation for their pleiotropic beneficial and adverse clinical effects.

Statins reduce atherosclerotic events and cardiovascular mortality. Their side effects include memory loss, myopathy, cataract formation, and increased risk of diabetes. As cardiovascular mortality relates to plaque instability, which depends on the integrity of the fibrous cap, we hypothesize that the inhibition of the potential of mesenchymal stem cells (MSCs) to differentiate into macrophages would help to explain the long known, but less understood "non-lipid-associated" or pleiotropic benefit of statins on cardiovascular mortality. In the present investigation, MSCs were treated with atorvastatin or pravastatin at clinically relevant concentrations and their proliferation, differentiation potential, and gene expression profile were assessed. Both types of statins reduced the overall growth rate of MSCs. Especially, statins reduced the potential of MSCs to differentiate into macrophages while they exhibited no direct effect on macrophage function. These findings suggest that the limited capacity of MSCs to differentiate into macrophages could possibly result in decreased macrophage density within the arterial plaque, reduced inflammation, and subsequently enhance plaque stability. This would explain the non-lipid-associated reduction in cardiovascular events. On a negative side, statins impaired the osteogenic and chondrogenic differentiation potential of MSCs and increased cell senescence and apoptosis, as indicated by upregulation of p16, p53 and Caspase 3, 8, and 9. Statins also impaired the expression of DNA repair genes, including XRCC4, XRCC6, and Apex1. While the effect on macrophage differentiation explains the beneficial side of statins, their impact on other biologic properties of stem cells provides a novel explanation for their adverse clinical effects.

The safety and efficacy of approaches to liver resection: a meta-analysis.

BACKGROUND: The aim of this study is to compare the safety and efficacy of conventional laparotomy with those of robotic and laparoscopic approaches to hepatectomy. DATABASE: Independent reviewers conducted a systematic review of publications in PubMed and Embase, with searches limited to comparative articles of laparoscopic hepatectomy with either conventional or robotic liver approaches. Outcomes included total operative time, estimated blood loss, length of hospitalization, resection margins, postoperative complications, perioperative mortality rates, and cost measures. Outcome comparisons were calculated using random-effects models to pool estimates of mean net differences or of the relative risk between group outcomes. Forty-nine articles, representing 3702 patients, comprise this analysis: 1901 (51.35%) underwent a laparoscopic approach, 1741 (47.03%) underwent an open approach, and 60 (1.62%) underwent a robotic approach. There was no difference in total operative times, surgical margins, or perioperative mortality rates among groups. Across all outcome measures, laparoscopic and robotic approaches showed no difference. As compared with the minimally invasive groups, patients undergoing laparotomy had a greater estimated blood loss (pooled mean net change, 152.0 mL; 95% confidence interval, 103.3-200.8 mL), a longer length of hospital stay (pooled mean difference, 2.22 days; 95% confidence interval, 1.78-2.66 days), and a higher total complication rate (odds ratio, 0.5; 95% confidence interval, 0.42-0.57). CONCLUSION: Minimally invasive approaches to liver resection are as safe as conventional laparotomy, affording less estimated blood loss, shorter lengths of hospitalization, lower perioperative complication rates, and equitable oncologic integrity and postoperative mortality rates. There was no proven advantage of robotic approaches compared with laparoscopic approaches.

Retained foreign bodies: risk and outcomes at the national level.

BACKGROUND: Retained foreign bodies (RFB) after operative interventions are linked to an increased risk of morbidity and mortality, and represent a medico-legal liability. We aimed to identify associated risk factors and outcomes related to iatrogenic RFB in the United States. STUDY DESIGN: A cross-sectional analysis was performed on all interventions that resulted in a secondary diagnosis of RFB in the Nationwide Inpatient Sample (NIS) from 2003 to 2009. Comparative controls were randomly selected from patients who underwent similar procedures. RESULTS: We identified 3,045 cases of RFB, and 12,592 controls were included. The majority of incidents, 968 (31.8%), were reported after gastrointestinal interventions. Risk of RFB was higher in teaching hospitals (odds ratio [OR] 1.31, 95% CI [1.19, 1.45], p < 0.001). For abdominopelvic procedures, patients admitted with traumatic injuries did not demonstrate a higher risk of RFB compared with electively admitted patients (OR 1.70, 95% CI [0.94, 3.07], p = 0.08). However, for procedures unrelated to abdominopelvic surgery, patients admitted for trauma had a lower risk (OR 0.62, 95% CI [0.50, 0.78], p < 0.001). Obesity (BMI ≥ 30 kg/m(2)) and older age (≥ 65 years) were significantly associated with a higher risk only for abdominopelvic procedures (p < 0.01 for both). Retained foreign bodies were associated with a higher average cost of health services ($26,678.00 ± $769.69 vs $12,648.00 ± $192.80, p < 0.001). CONCLUSIONS: Retained foreign bodies have unfavorable and nationally tangible clinical and economic outcomes. The risk profile for RFB at the national level seems to demonstrate an association with demographic and clinical factors including nature of the procedure, type of admission, and trauma status. Teaching hospitals are associated with a higher risk. Targeted efforts toward identified high-risk populations are needed to avoid these morbid and costly complications.

Team training to establish a safety culture in dialysis access surgery.

Operating room (OR) team safety training and learning in the field of dialysis access is well suited for the use of simulators, simulated case learning and root cause analysis of adverse outcomes. The objectives of OR team training are to improve communication and leadership skills, to use checklists and to prevent errors. Other objectives are to promote a change in the attitudes towards vascular access from learning through mistakes in a nonpunitive environment, to positively impact the employee performance and to increase staff retention by making the workplace safer, more efficient and user friendly.

Patient safety in peritoneal dialysis.

Peritoneal dialysis (PD) is effective and safe when patients and caregivers understand the best practices. Health care teams responsible for PD must act in a coordinated and consistent manner to ensure the most effective outcomes. This chapter will review the evidence for PD and discuss the safety implications of the phases of PD from patient selection to education to maintenance.

Effectiveness of systems changes suggested by simulation of adverse surgical outcomes.

Background: Simulation of adverse outcomes (SAO) has been described as a technique to improve effectiveness of root cause analysis (RCA) in healthcare. We hypothesise that SAO can effectively identify unsuspected root causes amenable to systems changes. Methods: Systems changes were developed and tested for effectiveness in a modified simulation, which was performed eight times, recorded and analysed. Results: In seven of eight simulations, systems changes were effectively utilised by participants, who contacted anaesthesia using the number list and telephone provided to express concern. In six of seven simulations where anaesthesia was contacted, they provided care that avoided the adverse event. In two simulations, the adverse event transpired despite implemented systems changes, but for different reasons than originally identified. In one case, appropriate personnel were contacted but did not provide the direction necessary to avoid the adverse event, and in one case, the telephone malfunctioned. Conclusions: Systems changes suggested by SAO can effectively correct deficiencies and help improve outcomes, although adverse events can occur despite implementation. Further study of systems concepts may provide suggestions for changes that function more reliably in complex healthcare systems. The information gathered from these simulations can be used to identify potential deficiencies, prevent future errors and improve patient safety.

The impact of surgical volume on racial disparity in thyroid and parathyroid surgery.

PURPOSE: The aim of this study was to evaluate the association between surgeon volume and patient outcomes among different race ethnicities undergoing thyroid or parathyroid surgery. METHODS: The nationwide inpatient sample was used to identify all thyroidectomy and parathyroidectomy admissions from 2003 to 2009, using International Classification of Diseases, 9th Clinical Modification (ICD-9-CM) procedure codes. Race, demographic, and clinical characteristics of patients were collected, along with surgeon volume, to predict the length of stay (LOS), complication rates, mortality, and total charges by racial group, using univariate and multivariate analyses. RESULTS: A total of 106,314 thyroid and parathyroid surgeries were included in the current analysis. Of these patients, 54 % were Caucasian, 11 % African American, 7 % Hispanic, and 3 % Asian. Mean LOS was longer for African American patients (4 ± 8.7 days) than for Caucasians (2.3 ± 5.5 days) [p < 0.001]. African Americans had higher overall complications (16.8 %) compared with Caucasians (11 %), Hispanics (13.5 %), and Asians (12 %) [p < 0.001]. In-hospital mortality was higher for African Americans (0.8 %) compared with that from other race groups (0.3 %) [p < 0.001]. Mean total charges were significantly higher for African Americans ($33,292 ± $67,387) compared with those for Caucasians ($22,855 ± $40,167) (p < 0.001). African Americans had less access to intermediate- (10-99 cases) and high- (>100 cases) volume surgeons compared with Caucasians-45 versus 49 %, and 16 versus 19 %, respectively (p < 0.001). Higher surgeon volume was associated with improved outcomes (p < 0.001). Racial disparity in all investigated outcomes was still significantly evident even after stratification by surgeon volume. CONCLUSION: Higher surgeon volume is associated with improved patient outcomes. However, our data suggests that the observed racial disparities in thyroid and parathyroid surgery go beyond access to quality healthcare providers.

Using simulation to improve root cause analysis of adverse surgical outcomes.

OBJECTIVE: The purpose of this study was to develop and test a simulation method of conducting investigation of the causality of adverse surgical outcomes. DESIGN: Six hundred and thirty-one closed claims of a major medical malpractice insurance company were reviewed. Each case had undergone conventional root cause analysis (RCA). Claims were categorized by comparing the predominant underlying cause documented in the case files. Three cases were selected for simulation. SETTING: All records (medical and legal) were analyzed. Simulation scenarios were developed by abstracting data from the records and then developing paper and electronic medical records, choosing appropriate STUDY PARTICIPANTS: including test subjects and confederates, scripting the simulation and choosing the appropriate simulated environment. INTERVENTION: In a simulation center, each case simulation was run 6-7 times and recorded, with participants debriefed at the conclusion. MAIN OUTCOME MEASURES: Sources of error identified during simulation were compared with those noted in the closed claims. Test subject decision-making was assessed qualitatively. RESULTS: Simulation of adverse outcomes (SAOs) identified more system errors and revealed the way complex decisions were made by test subjects. Compared with conventional RCA, SAO identified root causes less focused on errors by individuals and more on systems-based error. CONCLUSIONS: The use of simulation for investigation of adverse surgical outcomes is feasible and identifies causes that may be more amenable to effective systems changes than conventional RCA. The information that SAO provides may facilitate the implementation of corrective measures, decreasing the risk of recurrence and improving patient safety.

The modern surgery department chairman: the job description as identified by chairmen.

IMPORTANCE: The role of the chairman of a surgery department is critical in academic surgery. However, little is known about the variability of job responsibilities. OBJECTIVE: To evaluate chairmen's responsibilities, methods of support, determinants of job performance success, and concerns. DESIGN: Internet-based survey. SETTING: Electronic survey system. PARTICIPANTS: Seventy-two chairmen. MAIN OUTCOMES AND MEASURES: Survey data on job responsibilities, methods of support, determinants of job performance success, and concerns. RESULTS: Of 168 chairmen who received the survey, 72 (43%) responded. The mean age of chairmen was 57 years (range, 44-78 years). Of 72 chairmen who responded, 69 (96%) were men, 67 (93%) were white, 65 (90%) were professors, 11 (15%) held a previous chair, 35 (49%) have advanced degrees, and 19 (26%) are program directors. Respondents are responsible for an average of 8.7 divisions, 60 (83%) spent 1 to 10 hours per week in the clinic, 45 (63%) performed surgery 1 to 10 hours per week, 54 (75%) took less than 6 call days per month, 44 (61%) published 1 to 6 papers per year and attended a mean (SD) of 4.3 (1.7) essential meetings per year, and 48 (67%) took 1 to 3 weeks of vacation annually. Chair salary support includes (from least to most) faculty tax, grants, endowment, school, and hospital. Compensation correlates with age, additional degree, specialty, location, contract, and tenure but not clinical hours. Reported compensation was consistent with data from the Association of American Medical Colleges, but 24 (33%) felt undercompensated. Incentives for job performance were given for clinical productivity (34 chairmen [47%]), department performance (50 [70%]), institutional performance (27 [38%]), and personal accomplishment (14 [19%]). Of 72 chairmen, 30 (42%) were concerned about personal liability related to the job, 15 (21%) had purchased personal liability insurance, and 20 (28%) have defended a lawsuit related to nonclinical responsibilities. CONCLUSIONS AND RELEVANCE: Academic surgery department chairmen have a wide array of responsibilities that have changed from historic standards. Success in the role of chairman may improve by appreciating the responsibilities, time allocation, methods of support, and concerns of other chairmen.