Human Factors Evaluation of the Universal Anaesthesia Machine: Assessing Equipment with High-Fidelity Simulation Prior to Deployment in a Resource-Constrained Environment.

BACKGROUND: Anesthesia providers in low- and middle-income countries face many challenges, including poor availability of functioning equipment designed to meet their environmental, organizational, and resource constraints. These are serious global health disparities which threaten access to care and patient safety for those who receive surgical care. In this study, we conducted a simulation-based human factors analysis of the Universal Anaesthesia Machine (UAM®), a device designed to support anesthesia providers in austere medical settings. Our team anticipated the introduction of the UAM® to the two major referral hospitals in Freetown, Sierra Leone. A prior observational study had identified these two hospitals as having environmental conditions consistent with an austere environment: an unstable electrical grid, as well as limited access to compressed oxygen, biomedical support, and consumables. Although the Baltimore simulation environment cannot reproduce all of the challenges present in a resource-constrained environment such as Sierra Leone, the major impediments to standard anesthesia machine functionality and human factors-associated use can be reproduced with the use of high-fidelity simulation. Using anesthesia care providers who have limited UAM® familiarity, this study allowed for the examination of machine-user issues in a controlled environment in preparation for further field studies concerning equipment introduction, training and device deployment in Sierra Leone. The goals of this study were: 1. to assess the usability of the UAM® (machine-user interface, simulated patient use, symbology, etc.) across different provider user groups during simulation of use in scenarios depicting routine use in healthy patients, use in clinically challenging patients and use in environmentally-challenging scenarios in a controlled setting devoid of patient risk, and 2. To gather feedback on available UAM manuals and cognitive aides and UAM usability issues in order to guide development of curricula for training providers on use of the UAM® in the intended austere clinical environments. METHODS: Residents, fellows, attending physician anesthesiologists, student nurse anesthetists, and nurse anesthetists participated in a variety of simulations involving the Universal Anaesthesia Machine® at the Johns Hopkins Medicine Simulation Center between September 2012 and July 2013. Data collected included participant demographics, performance during simulation scenarios captured with critical action checklists, workload ratings captured with the National Aeronautics and Space Administration Task Load Index (NASA TLX), and participant reactions to UAM® use captured through a post-session survey and semi-structured usability debriefing. The scenarios were: 1. normal use (machine check, induction, and maintenance of an uneventful case), 2. use in a challenging clinical condition (acute onset of bronchospasm) and 3.use in an adverse environmental event (power failure). Critical action checklists and workload ratings were analyzed by Analysis of Covariance (ANCOVA) to control for participant demographics. Usability debriefings were analyzed qualitatively. RESULTS: Thirty-five anesthesia providers participated in the study. Overall participant ratings, observations of performance in simulation scenarios, and usability debriefings indicated a high level of usability for the UAM®. Mean participant ratings were high for ease of use (5.4 ± 0.96) and clarity of instruction (6.2 ± 0.87) on a 7-point scale in which higher ratings indicate more positive perceptions. After adjusting for clinical experience, workload ratings were significantly higher in the bronchospasm scenario than in the normal/routine use (P = 0.046; 95% CI, 0.33-34.7) or power failure scenarios (P = 0.012; 95% CI, 5.24-37.9). Thirty-two specific usability issues were identified and grouped into five themes: device design and labeling, machine use during simulation scenarios, user-anticipated errors or hazards, curriculum issues, and overall impressions of the UAM®. CONCLUSIONS: The UAM® design addresses many of the key challenges facing anesthesia providers in resource-constrained settings. The simulation-based human factors evaluation described here successfully identified opportunities for continued refinement of the initial device design as well as issues to be addressed in future curricula and cognitive aides.

Data-driven approach to Early Warning Score-based alert management.

BACKGROUND: Increasing adoption of electronic health records (EHRs) with integrated alerting systems is a key initiative for improving patient safety. Considering the variety of dynamically changing clinical information, it remains a challenge to design EHR-driven alerting systems that notify the right providers for the right patient at the right time while managing alert burden. The objective of this study is to proactively develop and evaluate a systematic alert-generating approach as part of the implementation of an Early Warning Score (EWS) at the study hospitals. METHODS: We quantified the impact of an EWS-based clinical alert system on quantity and frequency of alerts using three different alert algorithms consisting of a set of criteria for triggering and muting alerts when certain criteria are satisfied. We used retrospectively collected EHRs data from December 2015 to July 2016 in three units at the study hospitals including general medical, acute care for the elderly and patients with heart failure. RESULTS: We compared the alert-generating algorithms by opportunity of early recognition of clinical deterioration while proactively estimating alert burden at a unit and patient level. Results highlighted the dependency of the number and frequency of alerts generated on the care location severity and patient characteristics. CONCLUSION: EWS-based alert algorithms have the potential to facilitate appropriate alert management prior to integration into clinical practice. By comparing different algorithms with regard to the alert frequency and potential early detection of physiological deterioration as key patient safety opportunities, findings from this study highlight the need for alert systems tailored to patient and care location needs, and inform alternative EWS-based alert deployment strategies to enhance patient safety.

Development of a Unifying Target and Consensus Indicators for Global Surgical Systems Strengthening: Proposed by the Global Alliance for Surgery, Obstetric, Trauma, and Anaesthesia Care (The G4 Alliance).

After decades on the margins of primary health care, surgical and anaesthesia care is gaining increasing priority within the global development arena. The 2015 publications of the Disease Control Priorities third edition on Essential Surgery and the Lancet Commission on Global Surgery created a compelling evidenced-based argument for the fundamental role of surgery and anaesthesia within cost-effective health systems strengthening global strategy. The launch of the Global Alliance for Surgical, Obstetric, Trauma, and Anaesthesia Care in 2015 has further coordinated efforts to build priority for surgical care and anaesthesia. These combined efforts culminated in the approval of a World Health Assembly resolution recognizing the role of surgical care and anaesthesia as part of universal health coverage. Momentum gained from these milestones highlights the need to identify consensus goals, targets and indicators to guide policy implementation and track progress at the national level. Through an open consultative process that incorporated input from stakeholders from around the globe, a global target calling for safe surgical and anaesthesia care for 80% of the world by 2030 was proposed. In order to achieve this target, we also propose 15 consensus indicators that build on existing surgical systems metrics and expand the ability to prioritize surgical systems strengthening around the world.

Time Series Analysis for Forecasting Hospital Census: Application to the Neonatal Intensive Care Unit.

BACKGROUND: Accurate prediction of future patient census in hospital units is essential for patient safety, health outcomes, and resource planning. Forecasting census in the Neonatal Intensive Care Unit (NICU) is particularly challenging due to limited ability to control the census and clinical trajectories. The fixed average census approach, using average census from previous year, is a forecasting alternative used in clinical practice, but has limitations due to census variations. OBJECTIVE: Our objectives are to: (i) analyze the daily NICU census at a single health care facility and develop census forecasting models, (ii) explore models with and without patient data characteristics obtained at the time of admission, and (iii) evaluate accuracy of the models compared with the fixed average census approach. METHODS: We used five years of retrospective daily NICU census data for model development (January 2008 - December 2012, N=1827 observations) and one year of data for validation (January - December 2013, N=365 observations). Best-fitting models of ARIMA and linear regression were applied to various 7-day prediction periods and compared using error statistics. RESULTS: The census showed a slightly increasing linear trend. Best fitting models included a non-seasonal model, ARIMA(1,0,0), seasonal ARIMA models, ARIMA(1,0,0)x(1,1,2)7 and ARIMA(2,1,4)x(1,1,2)14, as well as a seasonal linear regression model. Proposed forecasting models resulted on average in 36.49% improvement in forecasting accuracy compared with the fixed average census approach. CONCLUSIONS: Time series models provide higher prediction accuracy under different census conditions compared with the fixed average census approach. Presented methodology is easily applicable in clinical practice, can be generalized to other care settings, support short- and long-term census forecasting, and inform staff resource planning.

Anesthesia Practice and Perioperative Outcomes at Two Tertiary Care Hospitals in Freetown, Sierra Leone.

BACKGROUND: Anesthesia in West Africa is associated with high mortality rates. Critical shortages of adequately trained personnel, unreliable electrical supply, and lack of basic monitoring equipment are a few of the unique challenges to surgical care in this region. This study aims to describe the anesthesia practice at 2 tertiary care hospitals in Sierra Leone. METHODS: We conducted an observational study of anesthesia care at Connaught Hospital and Princess Christian Maternity Hospital in Freetown, Sierra Leone. Twenty-five percent of the anesthesia workforce in Sierra Leone, resident at both hospitals, was observed from June 2012 to February 2013. Perioperative assessments, anesthetic techniques, and intraoperative clinical and environmental irregularities were noted and analyzed. The postoperative status of observed cases was ascertained for morbidity and mortality. RESULTS: Between the 2 hospitals, 754 anesthesia cases and 373 general anesthetics were observed. Ketamine was the predominant IV anesthetic used. Both hospitals experienced infrastructural and environmental constraints to the delivery of anesthesia care during the observation period. Vital sign monitoring was irregular and dependent on age and availability of monitors. Perioperative mortality during the course of the study was 11.9 deaths/1000 anesthetics. CONCLUSIONS: We identified gaps in the application of internationally recommended anesthesia practices at both hospitals, likely caused by lack of available resources. Mortality rates were similar to those in other resource-limited countries.

Engaging staff to improve quality and safety in an austere medical environment: a case-control study in two Sierra Leonean hospitals.

QUALITY PROBLEM OR ISSUE: Inadequate observance of basic processes in patient care such as patient monitoring and documentation practices are potential impediments to the timely diagnoses and management of patients. These gaps exist in low resource settings such as Sierra Leone and can be attributed to a myriad of factors such as workforce and technology deficiencies. INITIAL ASSESSMENT: In the study site, only 12.4% of four critical vital signs were documented in the pre-intervention period. CHOICE OF SOLUTION: Implement a failure mode and effects analysis (FMEA) to improve documentation of four patient vital signs: temperature, blood pressure, pulse rate and respiratory rate. IMPLEMENTATION: FMEA was implemented among a subpopulation of health workers who are involved in monitoring and documenting patient vital signs. Pre- and post-FMEA monitoring and documentation practice were compared with a control site. EVALUATION: Participants identified a four-step process to monitoring and documenting vital signs, three categories of failure modes and four potential solutions. Based on 2100 patient days of documentation compliance data from 147 patients between July and November 2012, staff members at the study site were 1.79 times more likely to document all four patient vital signs in the post-implementation period (95% CI [1.35, 2.38]). LESSONS LEARNED: FMEA is a feasible and effective strategy for improving quality and safety in an austere medical environment. Documentation compliance improved at the intervention facility. To evaluate the scalability and sustainability of this approach, programs targeting the development of these types of process improvement skills in local staff should be evaluated.

Failure mode and effects analysis applied to the maintenance and repair of anesthetic equipment in an austere medical environment.

OBJECTIVE: Medical technology designed for Western settings frequently does not function adequately or as intended when placed in an austere clinical environment because of issues such as the instability of the electrical grid, environmental conditions, access to replacement parts, level of provider training and general absence of biomedical engineering support. The purpose of this study was to demonstrate the feasibility of applying failure mode and effects analysis as part of an implementation strategy for medical devices in austere medical settings. DESIGN: Observational case-study. SETTING/PARTICIPANTS/INTERVENTION: We conducted failure mode and effects analysis sessions with 16 biomedical engineering technicians at two tertiary-care hospitals in Freetown, Sierra Leone. The sessions focused on maintenance and repair processes for the Universal Anaesthesia Machine. Participating biomedical engineers detailed local maintenance and repair processes and failure modes, including resource availability, communication challenges, use errors and physical access to the machine. MAIN OUTCOME MEASURE(S): Qualitative descriptive themes in barriers perceived and solutions generated by biomedical engineers. RESULTS: Solutions generated involved redesigned work processes to increase the efficiency of identifying machine malfunctions, clinician engagement strategies, a formal plan for acquiring spare parts and plans for improving access to the machine. Follow-up interviews indicated solutions generated were implemented and perceived to be effective. CONCLUSIONS: This study demonstrates the feasibility of using the failure mode and effects analysis approach to improve implementation of technology in austere medical environments.

Assessing controlled substance prescribing errors in a pediatric teaching hospital: an analysis of the safety of analgesic prescription practice in the transition from the hospital to home.

UNLABELLED: Iatrogenic errors producing serious and often preventable injury occur frequently in hospitalized patients, particularly in children. Little is known about the epidemiology of analgesic medication errors in patients being discharged from the hospital. The goal of this study was to describe the epidemiology of controlled substance prescription errors by physicians-in-training for children being discharged from the hospital. We conducted a prospective, observational study of the analgesic prescriptions and discharge forms of 241 pediatric patients discharged from a Children's Center of a major urban teaching hospital from November 2003 to April 2004. All patients who were actively followed by the Pediatric Pain Service at the time of their discharge and were discharged with an analgesic prescription were included in the study. Primary outcome variables were the percentage of prescriptions that contained at least 1 medication error or potential adverse drug event. Errors were defined using the Institute for Safe Medication Practices' (ISMP) List of Error-Prone Abbreviations, Symbols, and Dose Designations, literature review, expert panel consensus, and the Johns Hopkins Department of Pharmacy hospital formulary. Two hundred forty-one patients who received 314 prescriptions were included in this study. Prescription errors were common; 257 of 314 (82%) of the prescriptions examined contained 1 or more errors. The most common errors were missing or wrong patient weight (n = 127, 77%), incomplete dispensing information (n = 167, 53%), and no or wrong date on prescription (n = 19, 6%). Nine prescriptions (2.9%) had the potential for significant medical injury and were considered potential adverse drug events. Discharge prescription errors for children requiring potent, opioid analgesic drugs in the management of pain are common, and nearly 3% could cause significant harm. The high rate of prescribing errors highlights the importance of developing, testing and implementing effective error-prevention strategies, especially in high-risk medications such as narcotics. PERSPECTIVE: Narcotic prescriptions written by trainees at discharge from a pediatric hospital are error prone and nearly 3% have the potential to cause significant harm. With a low therapeutic profile, the hospital may consider a review/verification process to reduce the risk of patient harm.

Perioperative anesthetic and analgesic management of newborn bladder exstrophy repair.

OBJECTIVE: Reconstruction of bladder exstrophy in newborn infants requires immobilization, sedation and pain management to prevent distracting forces from compromising the repair. We present a 6-year review of our experience. SUBJECTS AND METHODS: We reviewed the perioperative management of newborn infants undergoing reconstruction between November 1999 and October 2006. Data are presented as means+/-SD. RESULTS: Twenty-three newborn infants underwent surgery under a combined epidural and general anesthetic technique. Tunneled caudal epidural catheters were inserted in all patients and intermittently injected with 0.25% bupivacaine with 1:200,000 epinephrine. Postoperatively, a continuous infusion of 0.1% lidocaine, 0.8-1mg/kg/h was administered for 15+/-8 (range 4-30) days. Children were sedated with diazepam for 20+/-13 (range 2-40) days. Central venous catheters were maintained for 20+/-9 (range 1-34) days for fluids, drug administration and blood sampling. No patient experienced bladder prolapse or wound dehiscence. CONCLUSION: Perioperative management with tunneled epidural and central venous catheters in newborn infants with bladder exstrophy facilitates immobilization, analgesia and sedation, resulting in an excellent cosmetic repair with no case of bladder prolapse or wound dehiscence.

The effects of a small-dose naloxone infusion on opioid-induced side effects and analgesia in children and adolescents treated with intravenous patient-controlled analgesia: a double-blind, prospective, randomized, controlled study.

Opioids are frequently associated with side effects such as nausea, vomiting, and pruritus. We hypothesized that a prophylactic, continuous small-dose naloxone infusion would reduce the incidence of opioid-induced side effects without affecting analgesia or opioid consumption. In this prospective, double-blind, randomized, controlled clinical trial, we studied 46 postoperative patients (M:F, 21:25), averaging 14 +/- 2.5 yr and 53 +/- 17 kg, at the start of morphine IV patient-controlled analgesia. Patients were randomized to either saline (control, n = 26) or naloxone 0.25 microg . kg(-1) . h(-1) (n = 20). We found that the incidence and severity of pruritus (77% versus 20%; P < 0.05) and nausea (70% versus 35%; P < 0.05) was significantly more frequent in the placebo group compared with the naloxone group. Morphine consumption (1.02 +/- 0.41 mg . kg(-1) . d(-1) versus 1.28 +/- 0.61 mg . kg(-1) . d(-1)), pain scores at rest (4 +/- 2 versus 3 +/- 2), and pain scores with coughing (6 +/- 2 versus 6 +/- 2) were not different. We conclude that, in children and adolescents, a small-dose naloxone infusion (0.25 microg . kg(-1) . h(-1)) can significantly reduce the incidence and severity of opioid-induced side effects without affecting opioid-induced analgesia. When initiating morphine IV patient-controlled analgesia for the treatment of moderate to severe pain, clinicians should strongly consider starting a concomitant small-dose naloxone infusion.