Optimizing the surgical instrument tray to immediately increase efficiency and lower costs in the operating room.

BACKGROUND: Surgical trays are often poorly configured and can be ongoing sources of frustration and excess costs. We conducted an observational study to determine if the use of a customized mathematical inventory optimization model would result in a greater reduction in the number of instruments on a surgical tray than a clinician review of the tray. METHODS: Utilization of instruments on the major orthopedic tray at a large academic hospital was documented over 80 procedures. Processes in the medical device reprocessing department and operating room were observed to comprehensively quantify all associated costs. Results of the observations were applied to a customized mathematical model to determine the ideal tray configuration. For comparison, a clinician review was also performed. RESULTS: The mathematical model alone produced an ideal tray size of 47 instruments, a reduction of 41 instruments from the original size of 88 instruments (47% reduction). This represented $34 440 in annual savings. In contrast, the clinician review alone suggested an ideal tray size of 67 instruments (23% reduction), representing $17 640 in annual savings. When clinicians were provided with the additional information from the model, they reduced the tray size to 51 instruments (42% reduction), producing $31 870 in savings. The mathematical model yielded an additional 22% instrument reduction and $14 230 in savings compared with clinician review alone. CONCLUSION: Our mathematical model is generalizable and can be applied to all specialties and hospitals to determine optimal tray configuration. As such, the financial implications are broad; at our institution, application to all surgical trays would result in $205 000 of savings annually. Surgeons and managers looking to streamline surgical trays should consider this evidence-based approach.

Using Return on Investment Operational and Monte Carlo Modeling Techniques to Predict Financial Performance in a Tertiary Care Outpatient Clinic.

INTRODUCTION: The vast majority of health care quality improvement studies provide inadequate financial analysis to accurately predict a return on investment. We hypothesized that using return on invested capital operational mapping combined with a Monte Carlo simulation financial model could accurately predict institutional costs and operational metrics within an outpatient urology clinic. METHODS: A process map of a typical outpatient clinic visit was developed, and time studies were performed by following a sample of patients while considering all operational and financial variables that contributed to patient care. this process map was adapted into a return on invested capital-tree for financial modeling. Stochastic modeling using Monte Carlo simulation was performed to estimate financial metrics based on these operational and financial inputs for both the 2017-2018 and 2018-2019 fiscal years. These were then compared to the actual performance measures of those fiscal years. RESULTS: Combined return on invested capital-Monte Carlo simulation modeling generated financial and operational estimates that characterized the clinic's performance based on multivariable inputs. Most financial estimates for 2017-2018 differed by <4.31% from the actual financial values from that year. In predicting financial performance for 2018-2019, most of the estimated values were <7.67% different from their actual financial statement line items. CONCLUSIONS: As a proof of concept, this study demonstrated that a combined return on invested capital-operational mapping and Monte Carlo simulation modeling can predict key financial metrics in a tertiary care clinic. As such, common business tools can be useful in a health care setting when clinicians are evaluating how investments in quality improvement will influence their financial and operational performance.

Ethical concerns with online direct-to-consumer pharmaceutical companies.

In recent years, online direct-to-consumer pharmaceutical companies have been created as an alternative method for individuals to get prescription medications. While these companies have noble aims to provide easier, more cost-effective access to medication, the fact that these companies both issue prescriptions (via entirely online medical reviews that can have no direct contact between physician and patient) as well as distribute and ship medications creates multiple ethical concerns. This paper aims to explore two in particular. First, this model creates conflicts of interest for the physicians hired by these companies to write prescriptions. Second, the lack of direct contact from physicians may be harmful to prospective patients. After analysing these issues, this paper argues that there ought to be further consideration for regulation and oversight for these companies.

Clinical and Economic Value of Routine Pathological Examination of Hernia Sacs and Scheduled Clinic Follow-Ups After Inguinal Hernia and Hydrocele Repair in a Canadian Tertiary Care Children's Hospital.

BACKGROUND: The clinical and economical value of routine submission of hernia sacs for pathological examination and scheduled clinic follow-ups after inguinal hernia and hydrocele repair has been questioned. Herein, we assessed the institutional variability in these routine practices. METHODS: We retrospectively reviewed patients who underwent unilateral or bilateral inguinal hernia and/or hydrocele repair, open or laparoscopically, at our institution from 2015 to 2018. RESULTS: 1181 patients were included (1074 inguinal hernias and 157 hydroceles). Of 531 specimens obtained from 446 (38%) patients, 515 (97%) were normal. 16 (3%) abnormal pathological findings included 7 with mesothelial hyperplasia, 5 with nonfunctional genital ductal remnants, 3 with ectopic adrenal cortical tissues, and 1 epidydimal structure which was not recognized at the time of surgery. 418 (35%) patients had scheduled clinic follow-ups 65 (IQR 46-94) days postoperatively. 44 (4%) patients with unexpected postoperative Emergency Department visits within 30 days of surgery were identified. Only one patient required inpatient treatment, and the rest did not require intervention or admission. The total direct cost of analyzing specimens during the study period was $30,798 CAD ($10,266/year). The average cost to detect a potentially significant finding was $1924.88/specimen and $2053.20/patient. CONCLUSIONS: Routine pathological examination of hernia sacs and scheduled clinic follow-ups were associated with significant costs and predominantly nonsignificant findings. They should therefore be reserved for patients with a high clinical suspicion of injuries/abnormalities or risk factors for potential complications. LEVEL OF EVIDENCE: This is a level III evidence study.

Inventory management of reusable surgical supplies.

We investigate the inventory management practices for reusable surgical instruments that must be sterilized between uses. We study a hospital that outsources their sterilization services and model the inventory process as a discrete-time Markov chain. We present two base-stock inventory models, one that considers stockout-based substitution and one that does not. We derive the optimal base-stock level for the number of reusable instruments to hold in inventory, the expected service level, and investigate the implied cost of a stockout. We apply our theoretical results to a dataset collected from a surgical unit at a large tertiary care hospital specializing in colorectal operations. We demonstrate how to implement our model when determining base-stock levels for future capacity expansion and when considering alternative stockout protocols. Our analysis suggests that the hospital can reduce the number of reusable instrument sets held in inventory if on-site sterilization techniques (e.g., flash sterilization) are employed. Our results will guide future procurement decisions for surgical units based on costs and desired service levels.

Sunlight and Other Disinfectants: Disclosure Obligations under the Federal Securities and Drug Regulatory Regimes.

Drug development requires patience. Beyond the inherent uncertainty of the development process itself, U.S. drug developers must comply with the regulatory approval process overseen by the U.S. Food and Drug Administration (FDA). Because this process takes time, drug development also costs money. Drug companies seeking to raise funds in U.S. capital markets must navigate the securities regime governed by the Securities & Exchange Commission (SEC). Despite their similar roles as protectors of consumers and public markets, SEC and FDA send conflicting signals about the information drug companies need to disclose to the public. While SEC primarily regulates by mandating public disclosure, FDA has historically regulated drugs through its pre-approval process and has only recently begun to add disclosure mechanisms to its regulatory regime. Moreover, a trio of federal statutes requires FDA to keep sensitive information submitted by drug companies confidential. The regimes' distinct priorities and approaches create tensions that surface when publicly traded drug companies must decide whether and how to publicly disclose information related to drug development. This paper surveys the two agencies' conflicting priorities and regulations and explores the resulting problems that can arise for drug companies. It recommends that Congress liberalize statutory restraints on FDA's ability to disclose sponsor-submitted confidential information in order to help alleviate the tensions between these regimes and provide the public with more accurate information about drug companies and their products.

Patient and operational factors affecting wait times in a bariatric surgery program in Toronto: a retrospective cohort study.

BACKGROUND: Increasing rates of obesity have led to growing demand for bariatric surgery. This has implications for wait times, particularly in publicly funded programs. This study examined the impact of patient and operational factors on wait times in a multidisciplinary bariatric surgery program. METHODS: A retrospective study was conducted involving patients who were referred to a tertiary care centre (University Health Network, Toronto Western Hospital, Toronto) for bariatric surgery between June 2008 and July 2011. Patient characteristics, dates of clinical assessments and records describing operational changes were collected. Univariable analysis and multivariable log-linear and parametric time-to-event regressions were performed to determine whether patient and operational covariates were associated with the wait time for bariatric surgery (i.e., length of preoperative evaluation). RESULTS: Of the 1664 patients included in the analysis, 724 underwent surgery with a mean wait time of 440 (standard deviation 198) days and a median wait time of 445 (interquartile range 298-533) days. Wait times ranged from 3 months to 4 years. Univariable and multivariable analyses showed that patients with active substance use (ß = 0.3482, p = 0.02) and individuals who entered the program in more recent operational periods (ß = 0.2028, p < 0.001) had longer wait times. Additionally, the median time-to-surgery increased over 3 discrete operational periods (characterized by specific program changes related to scheduling and staffing levels, and varying referral rates and defined surgical targets; p < 0.001). INTERPRETATION: Some patients could be identified at referral as being at risk for longer wait times. We also found that previous operational decisions significantly increased the wait time in the program since its inception. Therefore, careful consideration must be devoted to process-level decision-making for multistage bariatric surgical programs, because managerial and procedural changes can affect timely access to treatment.

Analysis of patient attrition in a publicly funded bariatric surgery program.

BACKGROUND: Obesity is a global epidemic, and several surgical programs have been created to combat this public health issue. Although demand for bariatric surgery has grown, so too has the attrition rate. In this study we identify patient characteristics and operational interventions that have contributed to high attrition in a multistage, multidisciplinary bariatric surgery program. STUDY DESIGN: A retrospective study was conducted of 1,682 patients referred for bariatric surgery at the University Health Network in Toronto, Canada, from June 2008 to July 2011. Demographic information, presurgical assessment dates, and records describing operational changes were collected. Several penalized likelihood and mixed effects multivariable logistic regression models were used to determine whether patient characteristics, operational changes, and previous experience affected program completion and intermediate transitions between assessments. RESULTS: Although the majority of attrition appears to be the result of patient self-removal, males (odds ratio [OR] 0.511, 95% CI 0.392 to 0.663, p < 0.001), and individuals with active substance use (OR 0.223, 95% CI 0.096 to 0.471, p < 0.001) were less likely to undergo surgery. Operational practices had a detrimental effect on program completion (OR 0.590, 95% CI 0.456 to 0.762, p < 0.001). Conversely, patients with a BMI > 40 kg/m(2) (OR 1.756, 95% CI 1.233 to 2.515, p = 0.002) and those who lived within 25 to 300 km of the center (OR > 1.633, p < 0.001) were more likely to undergo surgery. CONCLUSIONS: Certain subgroups in the referral population were found to be at a higher risk of noncompletion. Specialized care pathways must be implemented to address this issue. Furthermore, careful consideration must be given to operational decisions because they may negatively affect access to care, as we have shown.

Quantitative Analysis of Operating Room Inventory Management Practices at a Tertiary Cancer Center.

PURPOSE: In Ontario, health care spending has grown to 45% of total government expenditures. In a public health care system, changes in demographics and the emergence of innovative technologies challenge our ability to adapt to evolving patient needs. To maintain a high standard of clinical effectiveness, there is a need to identify opportunities to improve health care delivery. This study was structured to meet the following objectives: to understand the operating room (OR) inventory practices at a tertiary academic hospital, to mathematically model this process to ascertain service levels based on changes in inventory and demand, and to define the appropriate level of reusable inventory for open and laparoscopic colorectal surgery. METHODS: We retrospectively reviewed OR throughput for all cases of colorectal cancer from January 1, 2010, to January 31, 2011. The process flow of OR instrumentation was studied to understand delays in the provision of inventory. Combining total surgeries performed with surgeon-specific instrument preferences generated daily instrument demand. We fitted parametric demand distributions for two instrument sets for major colon resections. Markovian models were used to estimate the distribution of available inventory and the likelihood of insufficient instruments on any given day. RESULTS: We reviewed 1,458 cases, 39.5% of which involved major open surgery, whereas 26.2% involved laparoscopic surgery. Demand for open and laparoscopic instrument sets was observed to fit binomial (20, 0.15) and Poisson (1.41) distributions, respectively. On the basis of these curves, we estimated the probability distribution of the in-stock inventory and, subsequently, the probability that demand would exceed supply on any given day ( Table 1 ). In particular, with 10 open and six laparoscopic sets currently owned by the institution, the probabilities that there would be insufficient inventory were 3.02% and 2.17%, respectively. [Table: see text] Conclusion: This analysis will guide purchasing decisions based on desired service levels and forecasted changes in demand. Furthermore, by ensuring that demand is being serviced, this analysis will help to curb loss of revenue, decrease wait times, and limit potential patient morbidity. Strategic purchasing can also reduce excessive inventory and therefore minimize shrinkage and obsolescence and increase working capital and institutional flexibility.

Aggressive fibromatosis of the parapharyngeal space: two cases and treatment recommendations.

Aggressive fibromatosis is an uncommon tumor that is locally aggressive but not malignant. Therefore, its classification falls between the benign and malignant neoplasms of soft-tissue origin. In the past, these lesions were misdiagnosed as low-grade fibrosarcomas. Otolaryngologists should be familiar with these lesions because as many as 15% of them occur in the head and neck. The treatment of choice is wide surgical excision, which is often difficult. Postexcision recurrence rates are high. Nonsurgical treatment includes radiation and chemotherapy, both of which are usually reserved for recurrences. We describe two cases of aggressive fibromatosis of the parapharyngeal space, and we review the available treatment options.