Development of a Preliminary Patient Safety Classification System for Generative AI.

Generative artificial intelligence (AI) technologies have the potential to revolutionise healthcare delivery but require classification and monitoring of patient safety risks. To address this need, we developed and evaluated a preliminary classification system for categorising generative AI patient safety errors. Our classification system is organised around two AI system stages (input and output) with specific error types by stage.

Development of Interoperable Computable Phenotype Algorithms for Adverse Events of Special Interest to Be Used for Biologics Safety Surveillance: Validation Study.

Background: Adverse events associated with vaccination have been evaluated by epidemiological studies and more recently have gained additional attention with the emergency use authorization of several COVID-19 vaccines. As part of its responsibility to conduct postmarket surveillance, the US Food and Drug Administration continues to monitor several adverse events of special interest (AESIs) to ensure vaccine safety, including for COVID-19.

Objective: This study is part of the Biologics Effectiveness and Safety Initiative, which aims to improve the Food and Drug Administration's postmarket surveillance capabilities while minimizing public burden.

Development and Validation of an Algorithm for Thrombosis with Thrombocytopenia Syndrome (TTS) at Unusual Sites.

Introduction: Thrombosis with thrombocytopenia syndrome (TTS) has been reported following receipt of adenoviral vector-based COVID-19 vaccines. However, no validation studies evaluating the accuracy of International Classification of Diseases-10-Clinical Modification (ICD-10-CM)-based algorithm for unusual site TTS are available in the published literature.

Methods: The purpose of this study was to assess the performance of clinical coding to 1) leverage literature review and clinical input to develop an ICD-10-CM-based algorithm to identify unusual site TTS as a composite outcome and 2) validate the algorithm against the Brighton Collaboration's interim case definition using laboratory, pathology, and imaging reports in an academic health network electronic health record (EHR) within the US Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative.

Characterization of COVID-19 Hospitalized Patients in Three United States Electronic Health Record Databases.

COVID-19 infections have contributed to substantial increases in hospitalizations. This study describes demographics, baseline clinical characteristics and treatments, and clinical outcomes among U.S.

"Are we there yet?" Ten persistent hazards and inefficiencies with the use of medication administration technology from the perspective of practicing nurses.

Objectives: (1) Characterize persistent hazards and inefficiencies in inpatient medication administration; (2) Explore cognitive attributes of medication administration tasks; and (3) Discuss strategies to reduce medication administration technology-related hazards.

Materials And Methods: Interviews were conducted with 32 nurses practicing at 2 urban, eastern and western US health systems. Qualitative analysis using inductive and deductive coding included consensus discussion, iterative review, and coding structure revision.

Detection of allergic transfusion-related adverse events from electronic medical records.

Background: Transfusion-related adverse events can be unrecognized and unreported. As part of the US Food and Drug Administration's Center for Biologics Evaluation and Research Biologics Effectiveness and Safety initiative, we explored whether machine learning methods, such as natural language processing (NLP), can identify and report transfusion allergic reactions (ARs) from electronic health records (EHRs).

Study Design And Methods: In a 4-year period, all 146 reported transfusion ARs were pulled from a database of 86,764 transfusions in an academic health system, along with a random sample of 605 transfusions without reported ARs.

Free-Text Computerized Provider Order Entry Orders Used as Workaround for Communicating Medication Information.

Objectives: Medication information is frequently communicated via free-text computerized provider order entry (CPOE) orders in electronic health records. When such information is transmitted separately from a structured CPOE medication order, there is a significant risk of medication error. Although prior studies have described the frequency of using free-text CPOE orders for communicating medication information, there is a gap in understanding the nature of the medication information contained in the free-text CPOE orders.

Identifying Electronic Medication Administration Record (eMAR) Usability Issues from Patient Safety Event Reports.

Background: Improving our understanding of the association between medication errors and health information technology (health IT) usability has the potential to reduce errors and improve patient safety. This study used patient safety event reports (PSEs) to investigate the contribution of usability challenges associated with the electronic medication administration record (eMAR) to medication errors.

Methods: Free-text descriptions of 849 medication-related PSEs selected from 2.

Clinician Perceptions on the Use of Free-Text Communication Orders.

Objective: The aim of this study was to investigate (1) why ordering clinicians use free-text orders to communicate medication information; (2) what risks physicians and nurses perceive when free-text orders are used for communicating medication information; and (3) how electronic health records (EHRs) could be improved to encourage the safe communication of medication information.

Methods: We performed semi-structured, scenario-based interviews with eight physicians and eight nurses. Interview responses were analyzed and grouped into common themes.

Identifying Health Information Technology Usability Issues Contributing to Medication Errors Across Medication Process Stages.

Objective: Different health information technology (health IT) systems are intended to support medication ordering, reviewing, and administration. We sought to identify the types of medication errors associated with health IT use, whether they reached the patient, where in the medication process those errors occurred, and the specific usability issues contributing to those errors.

Methods: Patient safety event reports from more than 595 healthcare facilities entered between January 2013 and September 2018 were analyzed.

Emergency Physician Perceptions of Electronic Health Record Usability and Safety.

Objectives: Despite requirements for electronic health record (EHR) vendor usability testing, usability challenges persist, contributing to patient safety concerns. We sought to identify emergency physicians' perceived EHR usability and safety strengths and shortcomings across major EHR vendor products.

Methods: Fifty-five emergency physicians from 4 different hospitals were interviewed.

Modeling patient-related workload in the emergency department using electronic health record data.

Introduction: Understanding and managing clinician workload is important for clinician (nurses, physicians and advanced practice providers) occupational health as well as patient safety. Efforts have been made to develop strategies for managing clinician workload by improving patient assignment. The goal of the current study is to use electronic health record (EHR) data to predict the amount of work that individual patients contribute to clinician workload (patient-related workload).

Advancing electronic health record vendor usability maturity: Progress and next steps.

Despite basic federal requirements promoting a user-centered design approach to electronic health record (EHR) development and usability testing there have been usability and safety risks with EHR technology. Four EHR vendors were asked to provide written descriptions of their usability practices, and we reviewed these descriptions to identify areas where there has been advancement and areas for improvement. All 4 vendors described user-centered design processes and usability testing methods that demonstrate advancement from previous studies of vendor practices.

Early mortality benefit with COVID-19 convalescent plasma: a matched control study.

Convalescent plasma can provide passive immunity during viral outbreaks, but the benefit is uncertain for the treatment of novel coronavirus disease 2019 (COVID-19). Our goal is to assess the efficacy of COVID-19 convalescent plasma (CCP). In all, 526 hospitalized patients with laboratory-confirmed SARS-CoV-2 at an academic health system were analyzed.

Communication through the electronic health record: frequency and implications of free text orders.

Communication for non-medication order (CNMO) is a type of free text communication order providers use for asynchronous communication about patient care. The objective of this study was to understand the extent to which non-medication orders are being used for medication-related communication. We analyzed a sample of 26 524 CNMOs placed in 6 hospitals.

Varying rates of patient identity verification when using computerized provider order entry.

Objective: We sought to determine rates of computerized provider order entry (CPOE) patient identity verification and when and where in the ordering process verification occurred.

Materials And Methods: Fifty-five physicians from 4 healthcare systems completed simulated patient scenarios using their respective CPOE system (Epic or Cerner). Eye movements were recorded and analyzed.

Ten Best Practices for Improving Emergency Medicine Provider-Nurse Communication.

Background: The current state of scientific knowledge regarding communication between emergency medicine (EM) providers indicates that communication is critical to safe and effective patient care.

Objectives: In this study, we identified communication needs of EM nurses and physicians; in particular, what information should be conveyed, when, how, and to whom.

Methods: Five semi-structured focus groups and one interview were conducted with nine nurses, eight attending physicians, and four residents.

Identifying Potential Patient Safety Issues From the Federal Electronic Health Record Surveillance Program.

This study uses Department of Health and Human Services data to analyze surveillance of electronic health records for patient safety issues to identify those with a potential for patient harm, and the frequency of these issues.

Design and Evaluation of an Integrated, Patient-Focused Electronic Health Record Display for Emergency Medicine.

Background: Hospital emergency departments (EDs) are dynamic environments, involving coordination and shared decision making by staff who care for multiple patients simultaneously. While computerized information systems have been widely adopted in such clinical environments, serious issues have been raised related to their usability and effectiveness. In particular, there is a need to support clinicians to communicate and maintain awareness of a patient's health status, and progress through the ED plan of care.

Qualitative findings from a pilot stage implementation of a novel organizational learning tool toward operationalizing the Safety-II paradigm in health care.

'Safety-II' is a new approach to safety, which emphasizes learning proactively about how safety and efficacy are achieved in everyday frontline work. Previous research developed a new lesson-sharing tool designed based on the Safety-II approach: Resilience Engineering Tool to Improve Patient Safety (RETIPS). The tool comprises questions designed to elicit narratives of adaptations that have contributed to effectiveness in care delivery.

Generality in multispecies responses to ocean acidification revealed through multiple hypothesis testing.

Decades of research have demonstrated that many calcifying species are negatively affected by ocean acidification, a major anthropogenic threat in marine ecosystems. However, even closely related species may exhibit different responses to ocean acidification and less is known about the drivers that shape such variation in different species. Here, we examine the drivers of physiological performance under ocean acidification in a group of five species of turf-forming coralline algae.

A usability and safety analysis of electronic health records: a multi-center study.

To characterize the variability in usability and safety of EHRs from two vendors across four healthcare systems (2 Epic and 2 Cerner). Twelve to 15 emergency medicine physicians participated from each site and completed six clinical scenarios. Keystroke, mouse click, and video data were collected.