Combined Proactive Risk Assessment: Unifying Proactive and Reactive Risk Assessment Techniques In Health Care.

BACKGROUND: Reactive risk assessments (RRAs) such as incident reporting and root cause analysis (RCA), as well as proactive risk assessments (PRAs) such as failure mode and effects analysis, are generally conducted independently in health care. Literature promotes combining risk assessment techniques. This concept builds on previous methodologies and presents an innovative, scalable, and generalizable risk assessment methodology. METHODS: A Combined Proactive Risk Assessment (CPRA) technique entails combining incident reports (RRAs), combining proactive risk assessments (PRAs), and merging components of PRA and RRA. Using specific keywords, this technique aligns patient safety reporting data with process steps and failure modes to assess risk within any of the process steps. This technique was tested by using PRAs from several Veterans Health Administration (VHA) facilities and national patient safety data from the VHA National Center for Patient Safety's database. Reported events and RCAs related to the outpatient blood draw process were used for this illustration. Repeatability was determined by independently applying the technique to two years of data and auditing results. RESULTS: Aggregating PRAs from multiple facilities identified 220% more failure modes; and integrating incident reports into PRA identified 310% more failure modes than the single facility average. Overlaying safety reports onto a comprehensive process flow diagram revealed that 85.8% of events occurred in three of seven process steps. Accuracy of this technique was generally above 85%. CONCLUSION: This technique is promising for identifying vulnerable points in health care processes or to compliment a traditional PRA. Single PRAs are less likely to identify all potential failures or focus on the most hazardous process steps. This technique may aid in assessing key health care processes at an enterprise level.

Patient Misidentification Events in the Veterans Health Administration: A Comprehensive Review in the Context of High-Reliability Health Care.

OBJECTIVES: The Veterans Health Administration maintains national patient safety event reporting and root cause analysis (RCA) databases. These were reviewed to understand the prevalence of and provide insight into patient misidentification. The results were compared with a high-reliability health care framework. METHODS: We reviewed patient safety reports and RCA reports to identify and categorize patient identification-related events from October 1, 2016, to September 30, 2018. We analyzed 3232 patient safety reports and 67 RCAs, aggregated the findings, and compared them against The Joint Commission's High Reliability Health Care Maturity Model. RESULTS: Patient misidentification occurred in both inpatient and outpatient settings, for which the ratio of adverse events to close calls was similar. The ratio of adverse events to close calls varied for specific care areas. The most common RCA event characteristic was Two identifiers not used (39%). The most common failure mode was Procedure performed on wrong patient (31%). Issues related to policy and processes accounted for 42% of the root causes. Actions taken were primarily related to policy, process, and staff training/education (56%); these actions were rated as effective by the reporting facilities. CONCLUSIONS: Patient misidentification is prevalent in both the inpatient and outpatient settings. However, specific care areas reported more close calls, an indicator of good safety culture. There were associations between policy and process issues, consistent use of 2 identifiers, and misidentification events. This review provides insight from the Veterans Health Administration national databases that health care institutions can use to improve their systems.

Cardiac Telemetry Downtime and Contingency Plan Development: A Review of Downtime Events Reported in the Veterans Health Administration.

BACKGROUND: Cardiac telemetry downtime may be planned or unplanned, causing a disruption in telemetry services with a potential to impact patient safety. PROBLEM: Many cardiac telemetry units in the Veterans Health Administration (VHA) have contingency plans that do not adequately address telemetry downtime. APPROACH: This is a retrospective quality improvement analysis of VHA-reported cardiac telemetry downtime events from October 1, 2014, to Mar 31, 2020. OUTCOMES: Of 98 events, no patient harm was reported; 13% (n = 13) were planned downtime, 82% (n = 80) were unplanned downtime, 18% (n = 18) reported contingency plan use, 78% (n = 76) did not specify contingency plan use, and 32% (n = 31) reported events lasting 31 minutes to 6 hours in duration. CONCLUSIONS: The majority of reported cardiac telemetry downtime events were unplanned and without documented contingency plans. A robust contingency plan with defined staff roles and responsibilities will serve to lessen anxiety during downtimes and mitigate potential risk of patient harm.

Assessment of unintended volume loss of six closed system transfer devices.

INTRODUCTION: Closed system transfer devices (CSTDs) are used to prepare and administer hazardous drugs. Previous studies have explored the vapor and fluid containment performance of CSTDs. A less obvious consideration is the effect of CSTD use on the intended dose for small volume administrations. We assessed six CSTDs to determine if they contribute to volume loss and delivery of less than the intended dose during simulated drug administration. METHODS: Using an analytical balance, we obtained the mass of each CSTD at four points during simulated drug preparation and subcutaneous administration using sterile water. We used the masses to determine the average volume loss (VL) for each CSTD. RESULTS: Using ANOVA, we identified significant differences in volume loss (VL) among the mean VL (F(6,59) = 18.45, p = 6.19 × 10-12) for the six CSTDs and control (no CSTD). Four CSTDs had a VL that was statistically different than the control (p < 0.05); the VL for two CSTDs was not statistically different than the control (p > 0.05). Volume loss did not depend on administration volume. CONCLUSION: Volume loss performance varied among CSTDs. Volume loss may be clinically significant for small volumes but is not likely clinically significant for larger volumes. It is the authors' opinion that 3 mL represents a reasonable administration threshold below which volume loss should be considered clinically significant. Users should consider volume loss in context of the tasks, drugs, users, and environments where CSTDs will be used. The United States Pharmacopeia (USP) General Chapter <800>: Hazardous Drugs-Handling in Healthcare Settings recognizes the lack of CSTD performance standards. USP <800> recommends independent performance evaluation of CSTDs based on peer-reviewed studies. Our study adds to the comparative performance evaluations of CSTDs available on the market at the time of this review.

Assessment of the Safety Risk of Dermatoscope Magnets in Patients With Cardiovascular Implanted Electronic Devices.

Importance: Cardiovascular implanted electronic devices (CIEDs) are susceptible to electromagnetic interference. Dermatologists regularly use devices containing magnets, including dermatoscopes and their attachments, which could pose a hazard to patients with CIEDs. Objective: To investigate the safety risk of magnets in dermatoscopes to patients with CIEDs. Design, Setting, and Participants: This cross-sectional observational study was conducted between January 1, 2018, and March 31, 2018, in a controlled laboratory setting. Two experiments were performed. In the first experiment (performed in the Dermatology Service at Memorial Sloan Kettering Cancer Center, New York), dermatoscopes that contain magnets were obtained from 3 manufacturers. Using a magnometer, the magnetic field strength of the dermatoscopes was measured over the magnet; at the faceplate; and at a distance of 0.5 cm, 1 cm and 15 cm away from the faceplate. In the second experiment (performed in the University Heart Center Zurich, Zurich, Switzerland), ex vivo measurements were conducted to determine how the dermatoscopes affected old-generation and new generation CIEDs (pacemakers and implantable defibrillators). Main Outcomes and Measures: Magnetic field strength as measured directly over the dermatoscope magnet; at the faceplate; and at distances of 0.5 cm, 1 cm, and 15 cm from the faceplate. Pacemaker and defibrillator operation when exposed to dermatoscopes. Results: After conducting 24 measurements, the magnetic field (measured in gauss [G]) strength varied between 24.26 G and 163.04 G over the dermatoscope magnet, between 2.22 G and 9.98 G at the dermatoscope faceplate, between 0.82 G and 2.4 G at a distance of 0.5 cm, and between 0.5 G and 1.04 G at a distance of 1 cm; it was 0 for all devices at a 15 cm distance. The field strength at the faceplate was found to be generally below the CIED industry standard safety threshold. None of the dermatoscopes in the ex vivo experiment exerted any demonstrable disruptions or changes to the CIEDs. Conclusions and Relevance: In real life, dermatoscope magnets likely present no measurable safety risk to patients with CIEDs. Using the polarized noncontact mode permits dermoscopy to be performed at least 0.5 cm from the skin surface, where the magnetic field strength was well below the 5-G safety threshold.