Trends in the Prevalence of Intraoperative Adverse Events at Two Academic Hospitals After Implementation of a Mandatory Reporting System.

BACKGROUND: Anesthesia information management systems (AIMSs) have been effectively used to improve quality in anesthesia care, and have enabled the development of mandatory quality assurance (QA) reporting systems for adverse events (AEs). While this approach has been shown to increase event reporting over time, the long-term effect of such a system on quality is unknown. We investigated the trends in AE reporting over time after implementing AIMS-based mandatory reporting systems at 2 academic medical centers. METHODS: At Thomas Jefferson University Hospital, AEs were retrieved after implementation of a mandatory QA process in 2013. These AEs were categorized as preventable and unpreventable. The rates of overall preventable and unpreventable AEs were analyzed over time. At Vanderbilt University Medical Center, the rates of AEs were analyzed after establishing a mandatory QA process in 2002. Data were binned by quarter, and trends over time were analyzed using the Mann-Kendall test. RESULTS: At Thomas Jefferson University Hospital, over a period of 2 years after implementation of a mandatory QA process, the documented AE rate decreased from 1.23% to 0.64% (P < .0001). This decrease occurred primarily in the group of preventable AEs, which declined from 1.01% to 0.52% (P = .014). The rate of unpreventable AEs was unchanged, from 0.22% to 0.12% (P = .12). At Vanderbilt University Medical Center, over a 7-year period after implementation, the AE rate decreased from 4.20% to 1.36% (P < .0001). CONCLUSIONS: After implementation of a mandatory QA process at 2 academic medical centers, documented AE rates decreased significantly. The decrease observed in preventable AEs, with unchanged rates of unpreventable AEs, demonstrates that mandatory reporting of intraoperative AEs was followed by a reduction in preventable intraoperative AEs. If our findings are replicated at other institutions and are shown to have a stronger trend compared with institutions where the implementation was not conducted, or there was a change from preimplementation trends, adding mandatory perioperative outcomes reporting in the AIMS may represent a valuable method to improve the overall safety of anesthesia.

Intraoperative Handoffs Among Anesthesia Providers Increase the Incidence of Documentation Errors for Controlled Drugs.

BACKGROUND: When electronic anesthesia records are compared to pharmacy transactions, discrepancies in total doses of controlled drugs are commonly found (≈16% of cases), potentially affecting patient safety and placing hospitals at risk for regulatory action. Errors (≈5%) persisted even with near real-time drug reconciliation feedback to providers. A study was conducted to test the hypothesis of greater risks of discrepancy for longer-duration cases and for intraoperative handoff involving a permanent handoff of care. METHODS: Anesthesia drug documentation and pharmacy transaction data were examined for all anesthetics between May 2014 and September 2015 at an academic medical center, and discrepancies between the two systems were determined. Nine logistic regression models were constructed to evaluate the influence of covariates (for example, case duration, general anesthesia vs. sedation, and handoff involving a permanent transfer of patient care) on the presence of a discrepancy. Linear regression was also performed between case duration decile and the logit (discrepancy rate), stratified by anesthesia type and handoff. RESULTS: For all models, handoffs were associated with higher discrepancy rates (p <10-6; odds ≥ 1.38). There was a progressive increase in discrepancy rates as a function of the case duration. CONCLUSIONS: Handoffs involving a permanent transfer of patient care during cases increase the risk of controlled drug discrepancies. Staff scheduling and assignment decisions to decrease the chance of a handoff occurring should help mitigate this. In addition, future studies should examine ways to improve the handoff process related to controlled drugs (for example, a formal, structured processes in the anesthesia information management system).

Controlled Substance Reconciliation Accuracy Improvement Using Near Real-Time Drug Transaction Capture from Automated Dispensing Cabinets.

BACKGROUND: Accurate accounting of controlled drug transactions by inpatient hospital pharmacies is a requirement in the United States under the Controlled Substances Act. At many hospitals, manual distribution of controlled substances from pharmacies is being replaced by automated dispensing cabinets (ADCs) at the point of care. Despite the promise of improved accountability, a high prevalence (15%) of controlled substance discrepancies between ADC records and anesthesia information management systems (AIMS) has been published, with a similar incidence (15.8%; 95% confidence interval [CI], 15.3% to 16.2%) noted at our institution. Most reconciliation errors are clerical. In this study, we describe a method to capture drug transactions in near real-time from our ADCs, compare them with documentation in our AIMS, and evaluate subsequent improvement in reconciliation accuracy. METHODS: ADC-controlled substance transactions are transmitted to a hospital interface server, parsed, reformatted, and sent to a software script written in Perl. The script extracts the data and writes them to a SQL Server database. Concurrently, controlled drug totals for each patient having care are documented in the AIMS and compared with the balance of the ADC transactions (i.e., vending, transferring, wasting, and returning drug). Every minute, a reconciliation report is available to anesthesia providers over the hospital Intranet from AIMS workstations. The report lists all patients, the current provider, the balance of ADC transactions, the totals from the AIMS, the difference, and whether the case is still ongoing or had concluded. Accuracy and latency of the ADC transaction capture process were assessed via simulation and by comparison with pharmacy database records, maintained by the vendor on a central server located remotely from the hospital network. For assessment of reconciliation accuracy over time, data were collected from our AIMS from January 2012 to June 2013 (Baseline), July 2013 to April 2014 (Next Day Reports), and May 2014 to September 2015 (Near Real-Time Reports) and reconciled against pharmacy records from the central pharmacy database maintained by the vendor. Control chart (batch means) methods were used between successive epochs to determine if improvement had taken place. RESULTS: During simulation, 100% of 10,000 messages, transmitted at a rate of 1295 per minute, were accurately captured and inserted into the database. Latency (transmission time to local database insertion time) was 46.3 ± 0.44 milliseconds (SEM). During acceptance testing, only 1 of 1384 transactions analyzed had a difference between the near real-time process and what was in the central database; this was for a "John Doe" patient whose name had been changed subsequent to data capture. Once a transaction was entered at the ADC workstation, 84.9% (n = 18 bins; 95% CI, 78.4% to 91.3%) of these transactions were available in the database on the AIMS server within 2 minutes. Within 5 minutes, 98.2% (n = 18 bins; 95% CI, 97.2% to 99.3%) were available. Among 145,642 transactions present in the central pharmacy database, only 24 were missing from the local database table (mean = 0.018%; 95% CI, 0.002% to 0.034%). Implementation of near real-time reporting improved the controlled substance reconciliation error rate compared to the previous Next Day Reports epoch, from 8.8% to 5.2% (difference = -3.6%; 95% CI, -4.3% to -2.8%; P < 10). Errors were distributed among staff, with 50% of discrepancies accounted for by 12.4% of providers and 80% accounted for by 28.5% of providers executing transactions during the Near Real-Time Reports epoch. CONCLUSIONS: The near real-time system for the capture of transactional data flowing over the hospital network was highly accurate, reliable, and exhibited acceptable latency. This methodology can be used to implement similar data capture for transactions from their drug ADCs. Reconciliation accuracy improved significantly as a result of implementation. Our approach may be of particular utility at facilities with limited pharmacy resources to audit anesthesia records for controlled substance administration and reconcile them against dispensing records.

Economic and Environmental Considerations During Low Fresh Gas Flow Volatile Agent Administration After Change to a Nonreactive Carbon Dioxide Absorbent.

BACKGROUND: Reducing fresh gas flow (FGF) during general anesthesia reduces costs by decreasing the consumption of volatile anesthetics and attenuates their contribution to greenhouse gas pollution of the environment. The sevoflurane FGF recommendations in the Food and Drug Administration package insert relate to concern over potential toxicity from accumulation in the breathing circuit of compound A, a by-product of the reaction of the volatile agent with legacy carbon dioxide absorbents containing strong alkali such as sodium or potassium hydroxide. Newer, nonreactive absorbents do not produce compound A, making such restrictions moot. We evaluated 4 hypotheses for sevoflurane comparing intervals before and after converting from a legacy absorbent (soda lime) to a nonreactive absorbent (Litholyme): (1) intraoperative FGF would be reduced; (2) sevoflurane consumption per minute of volatile agent administration would be reduced; (3) cost savings due to reduced sevoflurane consumption would (modestly) exceed the incremental cost of the premium absorbent; and (4) residual wastage in discarded sevoflurane bottles would be <1%. METHODS: Inspired carbon dioxide (PICO2), expired carbon dioxide, oxygen, air, and nitrous oxide FGF, inspired volatile agent concentrations (FiAgent), and liquid volatile agent consumption were extracted from our anesthesia information management system for 8 4 week intervals before and after the absorbent conversion. Anesthesia providers were notified by e-mail and announcements at Grand Rounds about the impending change and were encouraged to reduce their average intraoperative sevoflurane FGF to 1.25 L/min. Personalized e-mail reports were sent every 4 weeks throughout the study period regarding the average intraoperative FGF (i.e., from surgery begin to surgery end) for each agent. Batch means methods were used to compare FGF, volatile agent consumption, net cost savings, and residual sevoflurane left in bottles to be discarded in the trash after filling vaporizers. The time from reaching a PICO2 = 3 mm Hg for 3 minutes until agent exhaustion (PICO2 = 5 mm Hg for 5 minutes) was evaluated. RESULTS: A total of N = 20,235 cases were analyzed (80.2% sevoflurane, 15.1% desflurane, and 4.7% isoflurane). Intraoperative FGF was reduced for cases in which sevoflurane was administered by 435 mL/min (95% confidence interval [CI], 391 to 479 mL/min; P < 10). Hypothesis 1 was accepted. Sevoflurane consumption per minute of administration decreased by 0.039 mL/min (95% CI, 0.029 to 0.049 mL/min; P < 10) after the change to the nonreactive absorbent. Hypothesis 2 was accepted. The difference in mean cost for the sum of the sevoflurane and absorbent purchases for each of the 10 4-week intervals before and after the absorbent switch was -$293 per 4-week interval (95% CI, -$2853 to $2266; P = 0.81). Hypothesis 3 was rejected. The average amount of residual sevoflurane per bottle was 0.67 ± 0.06 mL (95% CI, 0.54 to 0.81 mL per bottle; P < 10 vs 2.5 mL). Hypothesis 4 was accepted. Once the PICO2 reached 3 mm Hg for at least 3 consecutive minutes, the absorbent became exhausted within 95 minutes in most (i.e., >50%) canisters. CONCLUSIONS: We showed that an anesthesia department can transition to a premium, nonreactive carbon dioxide absorbent in a manner that is at least cost neutral by reducing FGF below the lower flow limits recommended in the sevoflurane package insert. This was achieved, in part, by electronically monitoring PICO2, automatically notifying the anesthesia technicians when to change the absorbent, and by providing personalized feedback via e-mail to the anesthesia providers.

The HYSLAR trial: a prospective randomized controlled trial of the use of a restrictive fluid regimen with 3% hypertonic saline versus lactated Ringers in patients undergoing pancreaticoduodenectomy.

OBJECTIVE: This study was designed to determine whether the volume and type of fluid administered for pancreaticoduodenectomy impacts postoperative outcomes. BACKGROUND: Three percent hypertonic saline (HYS) has been suggested as a means of reducing the volume of fluid required to sustain tissue perfusion in the perioperative period. METHODS: Between May 2011 and November 2013, patients undergoing pancreaticoduodenectomy were enrolled in an institutional review board-approved, single-center, prospective, parallel, randomized controlled trial (NCT 01428050), comparing lactated Ringers (LAR) (15 mL/kg/hr LAR intraoperation, 2 mL/kg/hr LAR postoperation) with HYS (9 mL/kg/hr LAR and 1 mL/kg/hr HYS intraoperation, 1 mL/kg/hr HYS postoperation). RESULTS: A total of 264 patients were randomized. Demographic variables between groups were similar. The HYS patients had a significantly reduced net fluid balance (65 vs 91 mL/kg, P = 0.02). The overall complication rate was reduced in the HYS group (43% vs 54%), with a relative risk of 0.79 [95% confidence interval (CI), 0.62-1.02; P = 0.073], factoring stratification for pancreas texture. After adjustment for age and weight, the relative risk was 0.75 [95% CI (0.58-0.96); P = 0.023]. The total number of complications was significantly reduced in the HYS group (93 vs 123), with an incidence rate ratio of 0.74 [95% CI (0.56-0.97); P = 0.027]. After adjustment for age and weight, the incidence rate ratio was 0.69 [95% CI (0.52-0.90); P = 0.0068]. Reoperations, length of stay, readmissions, and 90-day mortality were similar between groups. CONCLUSIONS: A moderately restrictive fluid regimen with HYS resulted in a statistically significant 25% reduction in complications when adjusted for age, weight, and pancreatic texture.

Validation of a system to detect scheduled drug diversion by anesthesia care providers.

BACKGROUND: We recently described a method to identify drug diversion in the operating room (OR) from automated drug dispensing carts by anesthesia care providers, based on a retrospective outlier analysis of atypical transactions. Such transactions included those occurring on patients after their exit from the OR and on patients whose drugs were not dispensed at the location where the case was performed. In this report, we demonstrate prospectively the utility of our methodology to detect diversion by unsuspected individuals. METHODS: Each month, all transactions involving scheduled drugs by anesthesia care providers are downloaded from the pharmacy database and matched to case records from the anesthesia information management system. The frequency of atypical transactions is determined for each provider, normalized by the number of days they worked in the OR. For individuals who are >2 SDs above the mean for the month for any of the screening queries, a manual examination of their drug transaction logs is performed. Anesthesia records for such providers are examined manually to help determine the likelihood that diversion is taking place, and evidence of escalating activity is considered. Actions taken depend on an assessment of the strength of the evidence that diversion has been occurring. RESULTS: Two unsuspected individuals were identified prospectively as diverting drugs. Two individuals identified as abusing drugs recreationally outside the workplace showed no evidence of drug diversion through examination of the screening reports and transaction logs, and their rehabilitation treatment teams concurred that there was a very low probability of diversion. A final individual who demonstrated suspicious activity by the screening process was determined to have been careless in documentation practices, rather than diverting. CONCLUSIONS: The drug diversion screening methodology previously developed is valid for the prospective detection of unsuspected individuals diverting drugs from the OR. The system also provides material useful in the evaluation of possible diversion by anesthesia providers determined to be abusing drugs outside the workplace.

Development of a scheduled drug diversion surveillance system based on an analysis of atypical drug transactions.

BACKGROUND: Drug diversion in the operating room (OR) by anesthesia providers is a recognized problem with significant morbidity and mortality. Use of anesthesia drug dispensing systems in ORs, coupled with the presence of anesthesia or OR information management systems, may allow detection through database queries screening for atypical drug transactions. Although such transactions occur innocently during the course of normal clinical care, many are suspicious for diversion. METHODS: We used a data mining approach to search for possible indicators of diversion by querying our information system databases. Queries were sought that identified our two known cases of drug diversion and their onset. A graphical approach was used to identify outliers, with diversion subsequently assessed through a manual audit of transactions. RESULTS: Frequent transactions on patients after the end of their procedures, and on patients having procedures in locations different from that of the dispensing machine, identified our index cases. In retrospect, had we been running the surveillance system at the time, diversion would have been detected earlier than actually recognized. CONCLUSIONS: Identification of the frequent occurrence of atypical drug transactions from automated drug dispensing systems using database queries is a potentially useful method to detect drug diversion in the OR by anesthesia providers.