Towards the creation of a flexible classification scheme for voluntarily reported transfusion and laboratory safety events.

BACKGROUND: Transfusion and clinical laboratory services are high-volume activities involving complicated workflows across both ambulatory and inpatient environments. As a result, there are many opportunities for safety lapses, leading to patient harm and increased costs. Organizational techniques such as voluntary safety event reporting are commonly used to identify and prioritize risk areas across care settings. Creation of functional, standardized safety data structures that facilitate effective exploratory examination is therefore essential to drive quality improvement interventions. Unfortunately, voluntarily reported adverse event data can often be unstructured or ambiguously defined. RESULTS: To address this problem, we sought to create a "best-of-breed" patient safety classification for data contained in the Duke University Health System Safety Reporting System (SRS). Our approach was to implement the internationally recognized World Health Organization International Classification for Patient Safety Framework, supplemented with additional data points relevant to our organization. Data selection and integration into the hierarchical framework is discussed, as well as placement of the classification into the SRS. We evaluated the impact of the new SRS classification on system usage through comparisons of monthly average report rates and completion times before and after implementation. Monthly average inpatient transfusion reports decreased from 102.1 ± 14.3 to 91.6 ± 11.2, with the proportion of transfusion reports in our system remaining consistent before and after implementation. Monthly average transfusion report rates in the outpatient and homecare environments were not significantly different. Significant increases in clinical lab report rates were present across inpatient and outpatient environments, with the proportion of lab reports increasing after implementation. Report completion times increased modestly but not significantly from a practical standpoint. CONCLUSIONS: A common safety vocabulary can facilitate integration of information from disparate systems and processes to permit meaningful measurement and interpretation of data to improve safety within and across organizations. Formation of a "best-of-breed" classification for voluntary reporting necessitates an internal examination of localized data needs and workflow in order to design a product that enables comprehensive data capture. A team of clinical, safety, and information technology experts is necessary to integrate the data structures into the reporting system. We have found that a "best-of-breed" patient safety classification provides a solid, extensible model for adverse event analysis, healthcare leader communication, and intervention identification.

Culture counts--sustainable inpatient computerized surveillance across Duke University Health System.

PURPOSE: The authors report on the managerial and logistical details of deploying a computerized adverse drug event surveillance system that was at first a grant-funded research project and ultimately was changed to a sustained safety-monitoring application serving 3 different hospitals. METHODS: Surveillance was deployed in 3 phases to 2 community-based hospitals and an academic medical center. A logic-based rules engine surveyed electronic records for laboratory, medication, and demographic information indicative of safety concerns. Potential adverse events triggered manual chart review by pharmacists to verify patient harm. RESULTS: During Phase 1, the research team created trigger rules for each hospital. In Phase 2, the trigger review was transitioned to hospital personnel and rule sets were reshaped for specific hospital needs. In Phase 3, surveillance was integrated into daily work flows and organizational balanced scorecards where it was accepted as a quantitative measure of medication safety performance. DISCUSSION AND CONCLUSION: Computerized surveillance helps detect potentially harmful events regardless of hospital size. Active leadership, change-tolerant culture, and hospital pharmacy practice models significantly impact successful adoption. Entrenched cultural issues impeded sustainability at the academic center but not at the 2 community hospitals. Tailoring surveillance to the needs of different inpatient settings is crucial to developing a sustainable model.

Tailoring adverse drug event surveillance to the paediatric inpatient.

INTRODUCTION: Although paediatric patients have an increased risk for adverse drug events, few detection methodologies target this population. To utilise computerised adverse event surveillance, specialised trigger rules are required to accommodate the unique needs of children. The aim was to develop new, tailored rules sustainable for review and robust enough to support aggregate event rate monitoring. METHODS: The authors utilised a voluntary staff incident-reporting system, lab values and physician insight to design trigger rules. During Phase 1, problem areas were identified by reviewing 5 years of paediatric voluntary incident reports. Based on these findings, historical lab electrolyte values were analysed to devise critical value thresholds. This evidence informed Phase 2 rule development. For 3 months, surveillance alerts were evaluated for occurrence of adverse drug events. RESULTS: In Phase 1, replacement preparations and total parenteral nutrition comprised the majority (36.6%) of adverse drug events in 353 paediatric patients. During Phase 2, nine new trigger rules produced 225 alerts in 103 paediatric inpatients. Of these, 14 adverse drug events were found by the paediatric hypoglycaemia rule, but all other electrolyte trigger rules were ineffective. Compared with the adult-focused hypoglycaemia rule, the new, tailored version increased the paediatric event detection rate from 0.43 to 1.51 events per 1000 patient days. CONCLUSIONS: Relying solely on absolute lab values to detect electrolyte-related adverse drug events did not meet our goals. Use of compound rule logic improved detection of hypoglycaemia. More success may be found in designing real-time rules that leverage lab trends and additional clinical information.

Characteristics of ambulatory anticoagulant adverse drug events: a descriptive study.

BACKGROUND: Despite the high frequency with which adverse drug events (ADEs) occur in outpatient settings, detailed information regarding these events remains limited. Anticoagulant drugs are associated with increased safety concerns and are commonly involved in outpatient ADEs. We therefore sought to evaluate ambulatory anticoagulation ADEs and the patient population in which they occurred within the Duke University Health System (Durham, NC, USA). METHODS: A retrospective chart review of ambulatory warfarin-related ADEs was conducted. An automated trigger surveillance system identified eligible events in ambulatory patients admitted with an International Normalized Ratio (INR) >3 and administration of vitamin K. Event and patient characteristics were evaluated, and quality/process improvement strategies for ambulatory anticoagulation management are described. RESULTS: A total of 169 events in 167 patients were identified from December 1, 2006-June 30, 2008 and included in the study. A median supratherapeutic INR of 6.1 was noted, and roughly half of all events (52.1%) were associated with a bleed. Nearly 74% of events resulted in a need for fresh frozen plasma; 64.8% of bleeds were classified as major. A total of 59.2% of events were at least partially responsible for hospital admission. Median patient age was 68 y (range 36-95 y) with 24.9% initiating therapy within 3 months prior to the event. Of events with a prior documented patient visit (n = 157), 73.2% were seen at a Duke clinic or hospital within the previous month. Almost 80% of these patients had anticoagulation therapy addressed, but only 60.0% had a follow-up plan documented in the electronic note. CONCLUSIONS: Ambulatory warfarin-related ADEs have significant patient and healthcare utilization consequences in the form of bleeding events and associated hospital admissions. Recommendations for improvement in anticoagulation management include use of information technology to assist monitoring and follow-up documentation, avoid drug interactions, and engage patients in their care.

Tailoring "best-of-breed" safety classification for patient fall voluntary reporting.

OBJECTIVE: Voluntary safety event reporting often produces poorly defined data points, which complicate data analyses across health care settings. Such data should be restructured into a standard patient safety language translatable within and outside health care organizations. We designed and implemented a "best-of-breed" patient safety classification for data created by the Duke University Health System Safety Reporting System. METHODS: We report our approach for patient fall classification. Our strategy was to deploy the International Classification for Patient Safety Framework of the World Health Organization augmented with additional data points of interest, thereby allowing for data translatability while maintaining local practices. System interface redesign using the "best-of-breed" fall classification was mindful of workflows and known reporting barriers. Custom aggregate reports were also developed. RESULTS: We estimated the impact of the redesigned portal on Safety Reporting System usage before and after classification through comparisons of fall report volume and report completion time. When normalized as falls per day, the rate of falls only changed slightly, indicating that the enhancement had little effect on reporting desire. Report completion time increased modestly but not significantly from a practical standpoint. The presence of structured data eliminated substantial hours dedicated to manual data management and enabled evaluation of quality improvement interventions within and outside our organization. CONCLUSIONS: Creation and implementation of a "best-of-breed" patient safety classification for voluntary reporting requires multidisciplinary collaboration between clinical experts, frontline clinicians, and functional and technical analysts. Formal usability evaluations of reporting systems are needed to ensure design facilitates effective data collection.

Reevaluating the safety profile of pediatrics: a comparison of computerized adverse drug event surveillance and voluntary reporting in the pediatric environment.

OBJECTIVES: Children are at exceptionally high risk for adverse drug events. At Duke University Hospital, computerized adverse drug event surveillance and voluntary safety reporting systems work synergistically to identify adverse drug events. Here we identify the most deleterious drug classes to pediatric inpatients and determine which detection methodology provides the greatest opportunity to reduce harm. PATIENTS AND METHODS: We evaluated all of the medication-related events detected by our computerized surveillance and safety reporting systems over a 1-year period for Duke University Hospital pediatric inpatients. Events from both systems were scored for severity and assigned a drug event category. Surveillance events were additionally scored for causality. RESULTS: A total of 849 medication-related reports were entered into the safety reporting system, and 93 caused patient harm, resulting in an adverse drug event rate of 1.8 events per 1000 pediatric patient-days. Seventy eight of the 1537 medication-related events detected by surveillance resulted in patient harm, giving a rate of 1.6 events per 1000 patient-days. The most common events identified by the safety reporting system were failures in the medication use process (26.9%), drug omissions (16.1%), and dose- or rate-related events (12.9%). The most frequent adverse drug event surveillance categories were nephrotoxins (20.7%), narcotics and benzodiazepines (19.3%), and hypoglycemia (11.5%). Most voluntarily reported events originated in ICUs (72.0%), whereas surveillance events were split evenly across intensive and general care. There was little overlap between methodologies. CONCLUSIONS: The epidemiology of pediatric adverse drug events is best addressed by using voluntary reporting in tandem with other strategies, such as computerized surveillance and targeted chart review. Although voluntary reporting excels at identifying administration errors, surveillance excels at detecting adverse drug events caused by high-risk medications and identifies evolving conditions that may provoke imminent patient harm. Surveillance underperformed in pediatrics when compared with adult detection rates, suggesting that tailored rules may be necessary for a robust pediatric adverse drug event surveillance system.