Electronic Health Records Safety Research Articles

Decreasing Prescribing Errors in Antimicrobial Stewardship Program-Restricted Medications.

Antimicrobial stewardship programs (ASPs) restrict prescribing practices to regulate antimicrobial use, increasing the risk of prescribing errors. This quality improvement project aimed to decrease the proportion of prescribing errors in ASP-restricted medications by standardizing workflow. The study took place on all inpatient units at a tertiary care children's hospital between January 2020 and February 2022. Patients <22 years old with an order for an ASP-restricted medication course were included. An interprofessional team used the Model for Improvement to design interventions targeted at reducing ASP-restricted medication prescribing errors. Plan-Do-Study-Act cycles included standardizing communication and medication review, implementing protocols, and developing electronic health record safety nets. The primary outcome was the proportion of ASP-restricted medication orders with a prescribing error. The secondary outcome was time between prescribing errors. Outcomes were plotted on control charts and analyzed for special cause variation. Outcomes were monitored for a 3-month sustainability period. Nine-hundred ASP-restricted medication orders were included in the baseline period (January 2020-December 2020) and 1035 orders were included in the intervention period (January 2021-February 2022). The proportion of prescribing errors decreased from 10.9% to 4.6%, and special cause variation was observed in Feb 2021. Mean time between prescribing errors increased from 2.9 days to 8.5 days. These outcomes were sustained. Quality improvement methods can be used to achieve a sustained reduction in the proportion of ASP-restricted medication orders with a prescribing error throughout an entire children's hospital.

Inpatient EHR User Experience and Hospital EHR Safety Performance

Despite the broad adoption and optimization of electronic health record (EHR) systems across the continuum of care, serious usability and safety problems persist. To assess whether EHR safety performance is associated with EHR frontline user experience in a national sample of hospitals. This cross-sectional study included all US adult hospitals that used the National Quality Forum Leapfrog Health IT Safety Measure and also used the ARCH Collaborative EHR User experience survey from January 1, 2017, to January 1, 2019. Data analysis was performed from September 2020 to November 2022. The primary outcomes were hospital performance on the Leapfrog Health IT Safety measure (overall and 10 subcomponents) and the ARCH collaborative frontline user experience scores (overall and 8 subcomponents). Ordinary least squares models with survey responses clustered by hospital were used to assess associations between the overall measures and their subcomponents. There were 112 hospitals and 5689 frontline user surveys included in the study. Hospitals scored a mean of 0.673 (range, 0.297-0.973) on the Leapfrog Health IT safety measure; the mean ARCH EHR user experience score was 3.377 (range, 1 [best] to 5 [worst]). The adjusted β coefficient between the overall safety score and overall user experience score was 0.011 (95% CI, 0.006-0.016). The ARCH overall score was also significantly associated with 10 subcategory scores of the Leapfrog Health IT safety score, and the overall Leapfrog score was associated with the 8 subcategory scores of the ARCH user experience score. This cross-sectional study found a positive association between frontline user-rated EHR usability and EHR safety performance. This finding suggests that improving EHR usability, which is a current well-known pain point for EHR users, could have direct benefits in terms of improved EHR safety.

Enter and Discuss Orders and Prescriptions (EPA 4): A Curriculum for Fourth-Year Medical Students.

Order entry, entrustable professional activity (EPA) 4, is one of several EPAs that residency program directors identify as a weakness for PGY 1 residents. A multispecialty survey of program directors indicated that only 69% of interns could be trusted to enter and discuss orders and prescriptions without supervision. To address this gap, we developed a formative workshop for fourth-year medical students. Prior to the start of their subinternships, 366 fourth-year medical students engaged in an order entry workshop. Students performed chart reviews on electronic standardized patients within an educational electronic health record (EHR), placed admission orders, customized order sets, responded to safety alerts, utilized decision support tools, and incorporated high-value care considerations. Students used expert-validated rubrics to assess the quality of their admission orders and participated in a facilitated group discussion on key learning points. Finally, students participated in order entry, with all orders requiring cosignature by a supervising physician, during their clinical rotations. Students reported their confidence with order entry before and after the workshop and after the clinical rotation. One hundred seventeen students completed the pre- and postworkshop surveys, and 99 went on to complete the postcourse evaluation. Students showed a statistically significant increase in their confidence level following the workshop. Order entry is a critical, complex skill that requires deliberate instruction. This curriculum, which leverages the features of an educational EHR, can facilitate instruction, practice, and confidence gains regarding order entry prior to further application of these skills in the clinical environment.

Guidelines for US Hospitals and Clinicians on Assessment of Electronic Health Record Safety Using SAFER Guides

This Viewpoint summarizes safety assessment guidelines developed by the Centers for Medicare &amp; Medicaid Services to improve patients’ safety by optimizing clinicians’ use of electronic health record systems.

Is Electronic Health Record Safety a Paradox?

Electronic health records (EHRs) are now the most common method for documenting and communicating patient information, providing the most comprehensive view of patients’ intermittent experiences with the health care delivery system. Although use of EHRs has improved patient safety, the largest area of undesired consequences from EHR use has also involved patient safety: EHR-related errors have resulted in significant patient harm and even death.1,2A recent integrative review of the literature on the impact of EHRs on nurses’ cognitive work provides insights and highlights the impact of EHRs on nursing practice.3 The researchers found that most studies indicated EHRs did not support nurses forming and maintaining an overview of patients.3 Nurses found navigating EHRs to be challenging because of the scattered and fragmented presentation of information; they also experienced difficulty seeing the chronology of events and understanding clinical implications of various data.3 The template-driven design of documentation, as well as the restrictions on free text, made it difficult for nurses to express their clinical reasoning, and perhaps worse, understand the reasoning of others.3 Nurses found summary reports and handoff tools insufficient to support their work.3Although some suggest EHR risks to patient safety are primarily caused by nurse or user error, the reality is quite different. Understanding the underlying cause of EHR safety risk allows us to solve the problem and improve EHR safety. A statement in a recent article on clinical decision support (CDS) malfunction shed light on the nature of the broader EHR patient safety problem: it is “difficult to troubleshoot issues that appear in production [use] but not in the test environment.”4(p503) That statement captures the essence of use error, which is distinctly different from user error.5Use error is a “user action or lack of action that was different from that expected by the manufacturer and caused a result that (1) was different from the result expected by the user and (2) was not caused solely by device failure and (3) did or could result in harm.”6(p3) Use errors occur during the use of health information technologies, in this case, EHRs. Ideally, manufacturers should identify potential use errors while designing and testing EHRs, before they are used in the patient care environment.Because of the widespread use of EHRs and the potential impact of associated risks to patient safety, it is important to examine the current state of EHR safety. Is the delivery of health care safer or less safe with EHRs? What lessons have we learned for the use of EHRs? What is being done to improve HER safety, and is it enough? This issue of Technology Today considers these important questions.Although the use of computers in health care spans more than 5 decades, widespread use of EHRs did not begin until the past decade, following the passing of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2010.7 One of the key requirements of the legislation was that EHRs improve patient safety through features such as electronic medication prescribing and CDS. Some improvements have occurred, but there have been undesired consequences as well.Information on EHR safety as a major problem has come from multiple directions over the years. In a survey of members of the American Health Lawyers Association and the American Society for Healthcare Risk Management, 53% (of 369 responses) reported at least 1 serious EHR-related safety event within the preceding 5 years.8 The Joint Commission released a sentinel event alert on the importance of evaluating health information technology–related adverse events, including prevention and mitigation strategies to avoid patient harm.9 In 2019, the ECRI Institute highlighted inaccurate and missing information in EHRs as one of their top 10 patient safety concerns.10A study published in 2020 sought to answer the question: How did the safety performance of EHRs change in the United States from 2009 to 2018?11 Researchers found that EHR systems overall have only demonstrated modestly improved safety performance over 10 years. Of the 8657 hospital years observed, the most basic safety standards were met less than 70% of the time.11 The researchers did find a correlation between EHR vendors and medication safety performance, although specific vendors were not identified.11 The researchers concluded that hospitals that use EHR systems should routinely evaluate them for safety performance.11A 2020 report from Boston-based Coversys covering 10 years of nearly 12 000 events in 20 000 closed medical malpractice claims identified serious safety issues with EHRs.12 Specific findings related to EHRs included: The authors concluded that past malpractice data provide important signals for vulnerabilities in today’s EHRs.12The relationship between EHRs and patient safety is complex. But at the center of this safety paradox, you will often find the issue of usability. Although many nurses may not know the word usability or even the definition, they do spend a lot of time in the EHR recognizing what impedes their work and what helps it.Usability refers to the ease of use, usefulness, and satisfaction in achieving the desired goal when using EHRs.13 As noted by a Pew Charitable Trusts report14 quoting Norman,15 “Good usability should make it obvious to end users what they need to do.” This is true for EHRs; usability issues can be frustrating to clinicians and make their work unnecessarily more difficult.14Electronic health records play a central role in nursing practice today, which means even small usability issues can have a major impact on nurses’ workloads.7 For example, prior to EHRs, the documentation of patient pain required writing a few lines on paper. Now it requires locating a computer, logging in, finding the patient list, scrolling through the patient list to identify the correct patient, selecting the correct patient, responding to any pop-ups or alerts that may appear, navigating multiple screens to find the needed data elements, finding the right data element lists, scrolling through multiple lists of different data elements, clicking on multiple data elements, deciding if they have located all the desired data elements needed to document appropriately, closing the patient record, and logging off. The scenario is repeated when a nurse later documents the patient’s response to the pain intervention; this whole process is in contrast to simply jotting down a few words or lines on a piece of paper. And it is repeated with every assessment, every intervention, and every evaluation on every patient multiple times a shift.One might assume that nurses would become quicker at documenting over time as they learn the steps, shortcuts, and workarounds required to efficiently use EHRs, but that has not proven to be the case.7 Usability issues persist unless identified and fixed.14 Meanwhile, new features and content are routinely added, by vendors as well as health care organizations, that include usability issues.7 As a result, nurses’ use of EHRs includes activities supported by good EHR usability that improve their workflow and patient safety as well as poor usability that does the opposite.A seminal study by Lopez et al7 examined EHR-associated workload and usability effects over time, including whether EHR usability predicted workload. The researchers found a significant increase in perceived workload following EHR implementation that lasted the length of the longitudinal study, 2.5 years (P &lt; .001).7 The study is considered to cover the longest time period known to examine these variables. Researchers concluded that improving EHR usability should improve patient safety.7Poor EHR usability increases cognitive burden, which in turn creates threats to patient safety. For example, the structure of EHRs with poor usability may not match how nurses think and work. This requires additional cognitive effort for nurses to integrate the EHR into their complex and dynamic workflows, creating opportunities for missed data in decision-making.A recent report by the American Medical Informatics Association took a retrospective look at previous predictions made at their 2009 policy meeting.16 More than a decade ago they predicted EHR usability issues would increase clinicians’ cognitive load.16 Today, they find the magnitude of the burden was significantly underestimated.16The amount of data in EHRs continues to grow, negatively impacting patient safety as it increases the cognitive burden of clinicians. Drivers of information overload in the EHR extend beyond clinician-required data and include billing, quality improvement, avoiding malpractice, and compliance.17 The increasing amount of irrelevant data that must be waded through, complicated by screen sequences, poor data or information displays, excessive alerts, the mismatch between EHR workflow and clinician workflow, and more can all lead to information overload and cognitive burden.18,19 All of this information is compounded by the need to recall, organize, and synthesize data and information from diverse screens, increasing cognitive burden and creating an environment for errors.20 A study by Ahmed et al21 confirmed the effect of cognitive burden on error rates in clinical decision-making by comparing the use of a conventional EHR and a streamlined EHR displaying relevant information.Nurses know when they have to navigate multiple screens or wade through a lot of data to find something they need. But sometimes safety risks related to usability can be hidden where nurses cannot see. One example is an alert malfunction that occurs when a CDS feature does not work as intended or expected.22 A study on the malfunctioning of CDS alerts in 14 sites across the United States found many malfunctions caused alerts to fire for the wrong patients (false positives) and fail to fire for the right patients (false negatives).22 Three primary causes of error were build errors, conceptualization errors, and the introduction of new concepts or terms.3 For example, a malfunction occurred because an internally used identification (ID) number for a medication was updated but the associated alert logic was not updated to include the new ID number.22 Across the 14 sites, similar malfunction patterns recurred and included challenges during system upgrades, during code sets and values maintenance, during environment migration, and during design and implementation of CDS.22Another example of a hidden safety risk is autopopulation. Newly introduced EHR safety risks can be the result of attempts to improve EHR functionality for end users. Listed on ECRI’s Top 10 Health Technology Hazards for 2021 is the autopopulation of medications resulting in fatal errors.23 The functionality was updated to make searching and selecting medications easier. Once a few letters are entered into the drug entry field, several suggestions are generated for the end user, increasing the risk for an incorrect selection.Unfortunately, there are currently no standards for routine testing of EHR safety as there are in other high-risk industries such as the airline industry.14 Yet, we know EHR safety risks exist and that some cause harm. What is or can be done to improve these risks? The answer is complex.First, current testing of EHRs focuses on the work of EHR vendors and includes initial design and development.14 This testing often excludes how well the newly designed and developed functionality works in the practice setting.14Second, once EHRs are received by health care entities there is further design, configuration, customizations, and updates. These processes make EHRs sold by the same vendor different across different organizations.Third, testing for use errors that may lead to risks to patient safety requires an extensive evaluation of actual human-machine interaction. Nurses have a right to use safety in the technology they use. Use safety is defined by the US Food and Drug Administration (FDA) as, “freedom from unacceptable use-related risk.”24(p3) Unfortunately, the FDA stance on use safety does not apply to EHRs.Fourth, health care entities are increasingly working with external vendors to provide different content, such as CDS content. Who is responsible for ensuring the CDS content in the EHR is accurate and current at the point of use? Who is responsible for ensuring changes in content are implemented in a timely fashion and implemented in all relevant EHR areas?This complex landscape makes it difficult to identify the source of a particular EHR patient safety risk. It also makes it difficult to identify, prevent, and mitigate the risks themselves. Compounding the situation is a dearth of comprehensive EHR safety testing capabilities.14Blijleven and colleagues25 looked for origins and solutions to potential patient safety risks by examining the workarounds performed in EHR systems by nurses, physicians, and clerks working in a large university hospital. They identified 15 clinician rationales for workarounds including EHR usability, which the researchers defined as a high cost in time and effort for users in completing a task.25 One example of a usability-related workaround included copy-pasting patient data, which Blijleven et al25 found to decrease patient safety. While copy-paste functionality was implemented when clinicians encountered user-interface challenges, the practice was found to decrease patient safety and clinician effectiveness with negligible influence on efficiency.25Several leading organizations have developed approaches to preventing EHR-related risks to patient safety.14 These include Pew Charitable Trusts,14 American Medical Association,14 American Medical Informatics Association,26 Office of the National Coordinator for Health Information Technology,27 National Institute of Standards and Technology,28 and the American Nursing Informatics Association.29 Still, EHR safety risks persist. The Table outlines available resources and is well worth exploring for nurses involved in health care safety, those wanting to learn more about EHR safety, or those seeking to improve the safety of a current EHR.Given the complexity of the relationship between EHR safety and usability and all the ways problems can present, the solution to EHR-related safety risks may lie in taking a different approach entirely to EHRs versus spending time, effort, and money on researching and fixing current-state systems. Resources should focus on eliminating nonvalue data as well as simplifying, integrating, and automating data collection.30 Safety of current EHRs has become a paradox: although EHRs were created to improve patient safety, they have created new safety risks that can injure patients. Are we repeating the same big miss when dealing with EHR safety by not recognizing the complexity of health care, communication, and collaboration, as well as the differences between simple and complex software, and the impact of failures on the safe use of EHRs?31 The amount of empirical evidence on EHR safety and usability alone is staggering, making the paradoxical nature of EHR safety unacceptable.

Electronic Health Record safety performance

Electronic Health Record safety performance

Essential activities for electronic health record safety: A qualitative study.

Electronic health record-caused safety risks are an unintended consequence of the implementation of clinical systems. To identify activities essential to assuring that the electronic health record is managed and used safely, we used the Rapid Assessment Process, a collection of qualitative methods. A multidisciplinary team conducted visits to five healthcare sites to learn about best practices. Although titles and roles were very different across sites, certain tasks considered necessary by our subjects were remarkably similar. We identified 10 groups of activities/tasks in three major areas. Area A, decision-making activities, included overseeing, planning, and reviewing to assure electronic health record safety. Area B, organizational learning activities, involved monitoring, testing, analyzing, and reporting. Finally, Area C, user-related activities, included training, communication, and building clinical decision support. To minimize electronic health record-related patient safety risks, leaders in healthcare organizations should ensure that these essential activities are performed.

Safeuristics! Do Heuristic Evaluation Violation Severity Ratings Correlate with Patient Safety Severity Ratings for a Native Electronic Health Record Mobile Application?

Usability of electronic health records (EHRs) remains challenging, and poor EHR design has patient safety implications. Heuristic evaluation detects usability issues that can be classified by severity. The National Institute of Standards and Technology provides a safety scale for EHR usability. Our objectives were to investigate the relationship between heuristic severity ratings and safety scale ratings in an effort to analyze EHR safety. Heuristic evaluation was conducted on seven common mobile EHR tasks, revealing 58 heuristic violations and 28 unique usability issues. Each usability issue was independently scored for severity by trained hospitalists and a Human Factors researcher and for safety severity by two physician informaticists and two clinical safety professionals. Results demonstrated a positive correlation between heuristic severity and safety severity ratings. Regression analysis demonstrated that 49% of safety risk variability by clinical safety professionals (r = 0.70; n = 28) and 42% of safety risk variability by clinical informatics specialists (r = 0.65; n = 28) was explained by usability severity scoring of problems outlined by heuristic evaluation. Higher severity ratings of the usability issues were associated with increased perceptions of patient safety risk. This study demonstrated the use of heuristic evaluation as a technique to quickly identify usability problems in an EHR that could lead to safety issues. Detection of higher severity ratings could help prioritize failures in EHR design that more urgently require design changes. This approach is a cost-effective technique for improving usability while impacting patient safety. Results from this study demonstrate the efficacy of the heuristic evaluation technique to identify usability problems that impact safety of the EHR. Also, the use of interdisciplinary teams for evaluation should be considered for severity assessment.

Adherence to recommended electronic health record safety practices across eight health care organizations.

The Safety Assurance Factors for EHR Resilience (SAFER) guides were released in 2014 to help health systems conduct proactive risk assessment of electronic health record (EHR)- safety related policies, processes, procedures, and configurations. The extent to which SAFER recommendations are followed is unknown. We conducted risk assessments of 8 organizations of varying size, complexity, EHR, and EHR adoption maturity. Each organization self-assessed adherence to all 140 unique SAFER recommendations contained within 9 guides (range 10-29 recommendations per guide). In each guide, recommendations were organized into 3 broad domains: "safe health IT" (total 45 recommendations); "using health IT safely" (total 80 recommendations); and "monitoring health IT" (total 15 recommendations). The 8 sites fully implemented 25 of 140 (18%) SAFER recommendations. Mean number of "fully implemented" recommendations per guide ranged from 94% (System Interfaces-18 recommendations) to 63% (Clinical Communication-12 recommendations). Adherence was higher for "safe health IT" domain (82.1%) vs "using health IT safely" (72.5%) and "monitoring health IT" (67.3%). Despite availability of recommendations on how to improve use of EHRs, most recommendations were not fully implemented. New national policy initiatives are needed to stimulate implementation of these best practices.

Improving the safety of health information technology requires shared responsibility: It is time we all step up

In 2011, an Institute of Medicine report on health information technology (IT) and patient safety highlighted that building health-IT for safer use is a shared responsibility between key stakeholders including: “vendors, care providers, healthcare organizations, health-IT departments, and public and private agencies”. Use of electronic health records (EHRs) involves all these stakeholders, but they often have conflicting priorities and requirements. Since 2011, the concept of shared responsibility has gained little traction and EHR developers and users continue to attribute the substantial, long list of problems to each other. In this article, we discuss how these key stakeholders have complementary roles in improving EHR safety and must share responsibility to improve the current state of EHR use. We use real-world safety examples and outline a comprehensive shared responsibility approach to help guide development of future rules, regulations, and standards for EHR usability, interoperability and security as outlined in the 21st Century Cures Act. This approach clearly defines the responsibilities of each party and helps create appropriate measures for success. National and international policymakers must facilitate the local organizational and socio-political climate to stimulate the adoption of shared responsibility principles. When all major stakeholders are sharing responsibility, we will be more likely to usher in a new age of progress and innovation related to health IT.

Safety huddles to proactively identify and address electronic health record safety.

Objective: Methods to identify and study safety risks of electronic health records (EHRs) are underdeveloped and largely depend on limited end-user reports. “Safety huddles” have been found useful in creating a sense of collective situational awareness that increases an organization’s capacity to respond to safety concerns. We explored the use of safety huddles for identifying and learning about EHR-related safety concerns. Design: Data were obtained from daily safety huddle briefing notes recorded at a single midsized tertiary-care hospital in the United States over 1 year. Huddles were attended by key administrative, clinical, and information technology staff. We conducted a content analysis of huddle notes to identify what EHR-related safety concerns were discussed. We expanded a previously developed EHR-related error taxonomy to categorize types of EHR-related safety concerns recorded in the notes. Results: On review of daily huddle notes spanning 249 days, we identified 245 EHR-related safety concerns. For our analysis, we defined EHR technology to include a specific EHR functionality, an entire clinical software application, or the hardware system. Most concerns (41.6%) involved “EHR technology working incorrectly,” followed by 25.7% involving “EHR technology not working at all.” Concerns related to “EHR technology missing or absent” accounted for 16.7%, whereas 15.9% were linked to “user errors.” Conclusions: Safety huddles promoted discussion of several technology-related issues at the organization level and can serve as a promising technique to identify and address EHR-related safety concerns. Based on our findings, we recommend that health care organizations consider huddles as a strategy to promote understanding and improvement of EHR safety.

Patient and public views about the security and privacy of Electronic Health Records (EHRs) in the UK: results from a mixed methods study.

BackgroundAlthough policy discourses frame integrated Electronic Health Records (EHRs) as essential for contemporary healthcare systems, increased information sharing often raises concerns among patients and the public. This paper examines patient and public views about the security and privacy of EHRs used for health provision, research and policy in the UK.MethodsSequential mixed methods study with a cross-sectional survey (in 2011) followed by focus group discussions (in 2012-2013). Survey participants (N = 5331) were recruited from primary and secondary care settings in West London (UK). Complete data for 2761 (51.8 %) participants were included in the final analysis for this paper. The survey results were discussed in 13 focus groups with people living with a range of different health conditions, and in 4 mixed focus groups with patients, health professionals and researchers (total N = 120). Qualitative data were analysed thematically.ResultsIn the survey, 79 % of participants reported that they would worry about the security of their record if this was part of a national EHR system and 71 % thought the National Health Service (NHS) was unable to guarantee EHR safety at the time this work was carried out. Almost half (47 %) responded that EHRs would be less secure compared with the way their health record was held at the time of the survey. Of those who reported being worried about EHR security, many would nevertheless support their development (55 %), while 12 % would not support national EHRs and a sizeable proportion (33 %) were undecided. There were also variations by age, ethnicity and education. In focus group discussions participants weighed up perceived benefits against potential security and privacy threats from wider sharing of information, as well as discussing other perceived risks: commercial exploitation, lack of accountability, data inaccuracies, prejudice and inequalities in health provision.ConclusionsPatient and public worries about the security risks associated with integrated EHRs highlight the need for intensive public awareness and engagement initiatives, together with the establishment of trustworthy security and privacy mechanisms for health information sharing.Electronic supplementary materialThe online version of this article (doi:10.1186/s12911-015-0202-2) contains supplementary material, which is available to authorized users.

Electronic health record-related safety concerns: a cross-sectional survey.

Federal electronic health record (EHR)-related initiatives are leading to rapid increases in their adoption. Despite their benefits, EHRs also introduce new risks that can lead to serious safety events. We conducted a Web-based survey of the American Society for Healthcare Risk Management and the American Health Lawyers Association to elicit perceptions regarding the frequency and types of EHR-related serious safety events. We received 369 responses. The majority (66%) worked for large hospitals and health systems with varying degrees of EHR adoption. More than half (53%) of respondents reported at least one EHR-related serious safety event in the previous 5 years, and 10% reported more than 20 events. EHR workflow (63%), user familiarity with the EHR system (63%), and integration with existing systems (59%) were most frequently endorsed as variables associated with EHR-related serious safety events. Because EHR-related safety concerns are underreported, organizations should consider implementing robust measures of EHR safety within their institution as a key step for mitigating these concerns.

Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol

BackgroundImplementation and use of electronic health records (EHRs) could lead to potential improvements in quality of care. However, the use of EHRs also introduces unique and often unexpected patient safety risks. Proactive assessment of risks and vulnerabilities can help address potential EHR-related safety hazards before harm occurs; however, current risk assessment methods are underdeveloped. The overall objective of this project is to develop and validate proactive assessment tools to ensure that EHR-enabled clinical work systems are safe and effective.Methods/DesignThis work is conceptually grounded in an 8-dimension model of safe and effective health information technology use. Our first aim is to develop self-assessment guides that can be used by health care institutions to evaluate certain high-risk components of their EHR-enabled clinical work systems. We will solicit input from subject matter experts and relevant stakeholders to develop guides focused on 9 specific risk areas and will subsequently pilot test the guides with individuals representative of likely users. The second aim will be to examine the utility of the self-assessment guides by beta testing the guides at selected facilities and conducting on-site evaluations. Our multidisciplinary team will use a variety of methods to assess the content validity and perceived usefulness of the guides, including interviews, naturalistic observations, and document analysis. The anticipated output of this work will be a series of self-administered EHR safety assessment guides with clear, actionable, checklist-type items.DiscussionProactive assessment of patient safety risks increases the resiliency of health care organizations to unanticipated hazards of EHR use. The resulting products and lessons learned from the development of the assessment guides are expected to be helpful to organizations that are beginning the EHR selection and implementation process as well as those that have already implemented EHRs. Findings from our project, currently underway, will inform future efforts to validate and implement tools that can be used by health care organizations to improve the safety of EHR-enabled clinical work systems.

A red‐flag‐based approach to risk management of EHR‐related safety concerns

Although electronic health records (EHRs) have a significant potential to improve patient safety, EHR-related safety concerns have begun to emerge. Based on 369 responses to a survey sent to the memberships of the American Society for Healthcare Risk Management and the American Health Lawyers Association and supplemented by our previous work in EHR-related patient safety, we identified the following common EHR-related safety concerns: (1) incorrect patient identification; (2) extended EHR unavailability (either planned or unplanned); (3) failure to heed a computer-generated warning or alert; (4) system-to-system interface errors; (5) failure to identify, find, or use the most recent patient data; (6) misunderstandings about time; (7) incorrect item selected from a list of items; and (8) open or incomplete orders. In this article, we present a "red-flag"-based approach that can be used by risk managers to identify potential EHR safety concerns in their institutions. An organization that routinely conducts EHR-related surveillance activities, such as the ones proposed here, can significantly reduce risks associated with EHR implementation and use.

Use of simulation to assess electronic health record safety in the intensive care unit: a pilot study

ObjectiveTo establish the role of high-fidelity simulation training to test the efficacy and safety of the electronic health record (EHR)–user interface within the intensive care unit (ICU) environment.DesignProspective pilot study.SettingMedical...

Creating an Oversight Infrastructure for Electronic Health Record–Related Patient Safety Hazards

Electronic health records (EHRs) have potential quality and safety benefits. However, reports of EHR-related safety hazards are now emerging. The Office of the National Coordinator for Health Information Technology recently sponsored an Institute of Medicine committee to evaluate how health information technology use affects patient safety. In this article, we propose the creation of a national EHR oversight program to provide dedicated surveillance of EHR-related safety hazards and to promote learning from identified errors, close calls, and adverse events. The program calls for data gathering, investigation/analysis, and regulatory components. The first 2 functions will depend on institution-level EHR safety committees that will investigate all known EHR-related adverse events and near-misses and report them nationally using standardized methods. These committees should also perform routine safety self-assessments to proactively identify new risks. Nationally, we propose the long-term creation of a centralized, nonpartisan board with an appropriate legal and regulatory infrastructure to ensure the safety of EHRs. We discuss the rationale of the proposed oversight program and its potential organizational components and functions. These include mechanisms for robust data collection and analyses of all safety concerns using multiple methods that extend beyond reporting, multidisciplinary investigation of selected high-risk safety events, and enhanced coordination with other national agencies to facilitate broad dissemination of hazards information. Implementation of this proposed infrastructure can facilitate identification of EHR-related adverse events and errors and potentially create a safer and more effective EHR-based health care delivery system.

Legal, Ethical, and Financial Dilemmas in Electronic Health Record Adoption and Use

Electronic health records (EHRs) facilitate several innovations capable of reforming health care. Despite their promise, many currently unanswered legal, ethical, and financial questions threaten the widespread adoption and use of EHRs. Key legal dilemmas that must be addressed in the near-term pertain to the extent of clinicians' responsibilities for reviewing the entire computer-accessible clinical synopsis from multiple clinicians and institutions, the liabilities posed by overriding clinical decision support warnings and alerts, and mechanisms for clinicians to publically report potential EHR safety issues. Ethical dilemmas that need additional discussion relate to opt-out provisions that exclude patients from electronic record storage, sale of deidentified patient data by EHR vendors, adolescent control of access to their data, and use of electronic data repositories to redesign the nation's health care delivery and payment mechanisms on the basis of statistical analyses. Finally, one overwhelming financial question is who should pay for EHR implementation because most users and current owners of these systems will not receive the majority of benefits. The authors recommend that key stakeholders begin discussing these issues in a national forum. These actions can help identify and prioritize solutions to the key legal, ethical, and financial dilemmas discussed, so that widespread, safe, effective, interoperable EHRs can help transform health care.

Safe Electronic Health Record Use Requires a Comprehensive Monitoring and Evaluation Framework

Recent passage of the American Reinvestment and Recovery Act (ARRA) increases pressure on healthcare practitioners and organizations to implement currently available electronic health records (EHRs). Research and experience gained to date shows that such implementation efforts are difficult, costly, time-consuming, and fraught with many unintended consequences1. Evaluation of these systems after implementation suggests that they do not routinely meet safety standards of other safety-critical industries2. The aggressive timeline proposed in the ARRA bill means that a large number of practitioners and organizations will soon be attempting a monumental feat without the time or ability to customize these systems to their local workflows3. In a previous article, we proposed 8 dimensions or “rights” of EHR safety that addressed the complex social, technical, and personal issues associated with EHR use4. The goal of this article is to describe an approach for a comprehensive EHR monitoring and evaluation framework (i.e., the 8th dimension of EHR safety). Without such a comprehensive framework, safe and effective EHR use cannot be assured. This proposed framework has five essential components: 1) ability for practitioners and organizations to report patient safety events or potential hazards related to EHR use 5,6; 2) enhanced EHR certification that includes specific assurances that good software development procedures7 have been followed along with evidence that previously reported adverse events and hazards have been addressed; 3) self-assessment, attestation, testing, and reporting by both clinicians and healthcare organizations that all eight dimensions of safe EHR use have been addressed; 4) Local, state, and national oversight in the form of an on-site, in-person accreditation of EHRs as implemented and used by clinicians in the healthcare setting; 5) A national EHR-related adverse event investigation board that reviews incident reports and has the authority to investigate.