The Safety Assurance Factors for Electronic Health Record (EHR) Resilience (SAFER) Guides provide recommendations to healthcare organizations for conducting proactive self-assessments of the safety and effectiveness of their EHR implementation and use. Originally released in 2014, they were last updated in 2016. In 2022, the Centers for Medicare and Medicaid Services required their annual attestation by US hospitals. OBJECTIVES: This case study describes how SAFER Guide recommendations were updated to align with current evidence and clinical practice. MATERIALS AND METHODS: Over nine months, a multidisciplinary team updated SAFER Guides through literature reviews, iterative feedback, and online meetings. RESULTS: We reduced the number of recommended practices across all Guides by 40% and consolidated 9 Guides into 8 to maximize ease of use, feasibility, and utility. We provide a 4-level evidence grading hierarchy for each recommendation and a new 5-point rating scale to self-assess implementation status of the recommendation. We included 429 citations of which 289 (67%) were published since the 2016 revision. DISCUSSION: SAFER Guides were revised to offer EHR best practices, adaptable to unique organizational needs, with interactive content available at: https://www.healthit.gov/topic/safety/safer-guides. CONCLUSION: Revisions ensure that the 2025 SAFER Guides represent the best available current evidence for EHR developers and healthcare organizations.

A prior randomized controlled trial (RCT) showed no significant difference in wrong-patient errors between clinicians assigned to a restricted electronic health record (EHR) configuration (limiting to 1 record open at a time) versus an unrestricted EHR configuration (allowing up to 4 records open concurrently). However, it is unknown whether an unrestricted EHR configuration is more efficient. This substudy of the RCT compared clinician efficiency between EHR configurations using objective measures. All clinicians who logged onto the EHR during the substudy period were included. The primary outcome measure of efficiency was total active minutes per day. Counts were extracted from audit log data, and mixed-effects negative binomial regression was performed to determine differences between randomized groups. Incidence rate ratios (IRRs) were calculated with 95% confidence intervals (CIs). Among a total of 2556 clinicians, there was no significant difference between unrestricted and restricted groups in total active minutes per day (115.1 vs 113.3 min, respectively; IRR, 0.99; 95% CI, 0.93-1.06), overall or by clinician type and practice area.

OBJECTIVE: We sought to assess the quality of race and ethnicity information in observational health databases, including electronic health records (EHRs), and to propose patient self-recording as an improvement strategy. MATERIALS AND METHODS: We assessed completeness of race and ethnicity information in large observational health databases in the United States (Healthcare Cost and Utilization Project and Optum Labs), and at a single healthcare system in New York City serving a racially and ethnically diverse population. We compared race and ethnicity data collected via administrative processes with data recorded directly by respondents via paper surveys (National Health and Nutrition Examination Survey and Hospital Consumer Assessment of Healthcare Providers and Systems). Respondent-recorded data were considered the gold standard for the collection of race and ethnicity information. RESULTS: Among the 160 million patients from the Healthcare Cost and Utilization Project and Optum Labs datasets, race or ethnicity was unknown for 25%. Among the 2.4 million patients in the single New York City healthcare system's EHR, race or ethnicity was unknown for 57%. However, when patients directly recorded their race and ethnicity, 86% provided clinically meaningful information, and 66% of patients reported information that was discrepant with the EHR. DISCUSSION: Race and ethnicity data are critical to support precision medicine initiatives and to determine healthcare disparities; however, the quality of this information in observational databases is concerning. Patient self-recording through the use of patient-facing tools can substantially increase the quality of the information while engaging patients in their health. CONCLUSIONS: Patient self-recording may improve the completeness of race and ethnicity information.

To reduce the risk of wrong-patient errors, safety experts recommend allowing only one patient chart to be open at a time. Due to the lack of empirical evidence, the number of allowable open charts is often based on anecdotal evidence or institutional preference, and hence varies across institutions. Using an interrupted time series analysis of intercepted wrong-patient medication orders in an emergency department during 2010-2016 (83.6 intercepted wrong-patient events per 100 000 orders), we found no significant decrease in the number of intercepted wrong-patient medication orders during the transition from a maximum of 4 open charts to a maximum of 2 (b = -0.19, P = .33) and no significant increase during the transition from a maximum of 2 open charts to a maximum of 4 (b = 0.08, P = .67). These results have implications regarding decisions about allowable open charts in the emergency department in relation to the impact on workflow and efficiency.

To reduce the risk of wrong-patient errors, safety experts recommend limiting the number of patient records providers can open at once in electronic health records (EHRs). However, it is unknown whether health care organizations follow this recommendation or what rationales drive their decisions. To address this gap, we conducted an electronic survey via 2 national listservs. Among 167 inpatient and outpatient study facilities using EHR systems designed to open multiple records at once, 44.3% were configured to allow ≥3 records open at once (unrestricted), 38.3% allowed only 1 record open (restricted), and 17.4% allowed 2 records open (hedged). Decision-making centered on efforts to balance safety and efficiency, but there was disagreement among organizations about how to achieve that balance. Results demonstrate no consensus on the number of records to be allowed open at once in EHRs. Rigorous studies are needed to determine the optimal number of records that balances safety and efficiency.

OBJECTIVE: To systematically review the literature pertaining to asynchronous automated electronic notifications of laboratory results to clinicians. METHODS: PubMed, Web of Science, and the Cochrane Collaboration were queried for studies pertaining to automated electronic notifications of laboratory results. A title review was performed on the primary results, with a further abstract review and full review to produce the final set of included articles. RESULTS: The full review included 34 articles, representing 19 institutions. Of these, 19 reported implementation and design of systems, 11 reported quasi-experimental studies, 3 reported a randomized controlled trial, and 1 was a meta-analysis. Twenty-seven articles included alerts of critical results, while 5 focused on urgent notifications and 2 on elective notifications. There was considerable variability in clinical setting, system implementation, and results presented. CONCLUSION: Several asynchronous automated electronic notification systems for laboratory results have been evaluated, most from >10 years ago. Further research on the effect of notifications on clinicians as well as the use of modern electronic health records and new methods of notification is warranted to determine their effects on workflow and clinical outcomes.

OBJECTIVE: Medication-indication information is a key part of the information needed for providing decision support for and promoting appropriate use of medications. However, this information is not readily available to end users, and a lot of the resources only contain this information in unstructured form (free text). A number of public knowledge bases (KBs) containing structured medication-indication information have been developed over the years, but a direct comparison of these resources has not yet been conducted. MATERIAL AND METHODS: We conducted a systematic review of the literature to identify all medication-indication KBs and critically appraised these resources in terms of their scope as well as their support for complex indication information. RESULTS: We identified 7 KBs containing medication-indication data. They notably differed from each other in terms of their scope, coverage for on- or off-label indications, source of information, and choice of terminologies for representing the knowledge. The majority of KBs had issues with granularity of the indications as well as with representing duration of therapy, primary choice of treatment, and comedications or comorbidities. DISCUSSION AND CONCLUSION: This is the first study directly comparing public KBs of medication indications. We identified several gaps in the existing resources, which can motivate future research.

OBJECTIVE: Electronic health records (EHRs) contain information to detect adverse drug reactions (ADRs), as they contain comprehensive clinical information. A major challenge of using comprehensive information involves confounding. We propose a novel data-driven method to identify ADR signals accurately by adjusting for confounders. MATERIALS AND METHODS: We focused on two serious ADRs, rhabdomyolysis and pancreatitis, and used information in 264,155 unique patient records. We identified an ADR using established criteria, selected potential confounders, and then used penalized logistic regressions to estimate confounder-adjusted ADR associations. A reference standard was created to evaluate and compare the precision of the proposed method and four others. RESULTS: Precision was 83.3% for rhabdomyolysis and 60.8% for pancreatitis when using the proposed method, and we identified several drug safety signals that are interesting for further clinical review. DISCUSSION: The proposed method effectively estimated ADR associations after adjusting for confounders. A main cause of error was probably due to the nature of the dataset in that a substantial number of patients had a single visit only and, therefore, it was not possible to determine correctly the appropriate sequence of events for them. It is likely that performance will be improved with use of EHR data that contain more longitudinal records. CONCLUSIONS: This data-driven method is effective in controlling for confounding, resulting in either a higher or similar precision when compared with four comparators, has the unique ability to provide insight into confounders for each specific medication-ADR pair, and can be easily adapted to other EHR systems.

OBJECTIVE: Data-mining algorithms that can produce accurate signals of potentially novel adverse drug reactions (ADRs) are a central component of pharmacovigilance. We propose a signal-detection strategy that combines the adverse event reporting system (AERS) of the Food and Drug Administration and electronic health records (EHRs) by requiring signaling in both sources. We claim that this approach leads to improved accuracy of signal detection when the goal is to produce a highly selective ranked set of candidate ADRs. MATERIALS AND METHODS: Our investigation was based on over 4 million AERS reports and information extracted from 1.2 million EHR narratives. Well-established methodologies were used to generate signals from each source. The study focused on ADRs related to three high-profile serious adverse reactions. A reference standard of over 600 established and plausible ADRs was created and used to evaluate the proposed approach against a comparator. RESULTS: The combined signaling system achieved a statistically significant large improvement over AERS (baseline) in the precision of top ranked signals. The average improvement ranged from 31% to almost threefold for different evaluation categories. Using this system, we identified a new association between the agent, rasburicase, and the adverse event, acute pancreatitis, which was supported by clinical review. CONCLUSIONS: The results provide promising initial evidence that combining AERS with EHRs via the framework of replicated signaling can improve the accuracy of signal detection for certain operating scenarios. The use of additional EHR data is required to further evaluate the capacity and limits of this system and to extend the generalizability of these results.