Dean F Sittig

This important volume provide a one-stop resource on the SAFER Guides along with the guides themselves and information on their use, development, and evaluation. The Safety Assurance Factors for EHR Resilience (SAFER) guides, developed by the editors of this book, identify recommended practices to optimize the safety and safe use of electronic health records (EHRs). These guides are designed to help organizations self-assess the safety and effectiveness of their EHR implementations, identify specific areas of vulnerability, and change their cultures and practices to mitigate risks.

This book provides EHR designers, developers, implementers, users, and policymakers with the requisite historical context, clinical informatics knowledge, and real-world, practical guidance to enable them to utilize the SAFER Guides to proactively assess the safety and effectiveness of their electronic health records EHR implementations.

The first five chapters are designed to provide readers with the conceptual knowledge required to understand why and how the guides were developed. The next nine chapters focus on the underlying informatics concepts, key research activities, and methods used to develop each of the guides. Each of these chapters concludes with a copy of the guide itself. The final chapter provides a vision for the future and the work required to ensure that future generations of EHRs are designed, developed, implemented, and used to improve the overall safety of the EHR-enabled healthcare system.

Taken together, the information provided in this book should help any organization, whether large or small, implement its EHR program and improve the safety and effectiveness of its existing EHR-enabled healthcare systems.

This volume will be extremely valuable to small, ambulatory physician practices and larger outpatient settings as well as for hospitals and professors and instructors charged with teaching safe and effective implementation and use of EHRs. It will also be highly useful for health information technology professionals responsible for maintaining a safe and effective EHR and for clinical and administrative staff working in EHR-enabled healthcare systems.

As the number of healthcare organizations beginning to implement clinical information systems grows, the number of unanticipated and unintentional consequences inevitably increases as well.  While existing research suggests that much good can come from clinicians entering orders directly, errors or other unintended consequences related to technology may arise.  Ideal for both clinicians and information technology professionals, Clinical Information Systems: Overcoming Adverse Consequences helps fledgling organizations better prepare for the inevitable challenges and obstacles they will face upon the implementation of such systems.  Based on the research and findings from the Provider Order Entry Team from the Oregon Health & Science University, this book discusses the nine categories of unintended adverse consequences that occurred at many of the leading medical centers during their implementation and maintenance of a state-of-the-art clinical information system. It goes on to present the best practices they identified to help organizations overcome these obstacles.

Improving Medication Use and Outcomes with Clinical Decision Support: A Step-by-Step Guide is the result of a ground-breaking collaboration by dozens of individuals and organizations, with diverse perspectives and competencies. The Guide is designed to help clinical decision support implementers improve medication use (and associated outcomes) in their organizations by providing practical recommendations for successfully implementing CDS focused on these targets.

Chapters include detailed guidance on key areas in an effective CDS-medication management program such as optimizing governance structures and management processes, defining outcome improvement opportunities and baselines; setting up interventions in key clinical information systems and for specific targets; deploying CDS interventions to optimize acceptance and value; measuring results and refining the program; and approaching CDS knowledge management systematically. An appendix includes information on the use of CDS for prescription safety in the small practice environment.

Most computerized physician order entry (CPOE) systems have built-in support for order sets (collections of orders grouped by a clinical purpose). Evidence and experience suggest that order sets are important tools for ordering efficiency and decision support and may influence ordering. Developing and maintaining order sets is costly, so hospitals often must prioritize which order sets can be created. We analyzed order set utilization at seven diverse sites with CPOE. The number of order sets per site ranged from 81 to 535, and the number of order set uses per discharge ranged from 0.48 to 9.89. We also compared the top ten order sets at each site, and found many commonalities, such as generic and condition-specific admission order sets, surgical sets and clinical pathways. We also found that, at each site, utilization of order sets was skewed, with a small number of order sets comprising the bulk of utilization. These findings may be useful for order sets developers, particularly in settings where resources are constrained and the most important order sets must be developed first.

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Using an eight-dimensional model for studying socio-technical systems, a multidisciplinary team of investigators identified barriers and facilitators to clinical decision support (CDS) implementation in a community setting, the Mid-Valley Independent Physicians Association in the Salem, Oregon area. The team used the Rapid Assessment Process, which included nine formal interviews with CDS stakeholders, and observation of 27 clinicians. The research team, which has studied 21 healthcare sites of various sizes over the past 12 years, believes this site is an excellent example of an organization which is using a commercially available electronic-health-record system with CDS well. The eight-dimensional model proved useful as an organizing structure for the evaluation.

Using an eight-dimensional model for studying socio-technical systems, a multidisciplinary team of investigators identified barriers and facilitators to clinical decision support (CDS) implementation in a community setting, the Mid-Valley Independent Physicians Association in the Salem, Oregon area. The team used the Rapid Assessment Process, which included nine formal interviews with CDS stakeholders, and observation of 27 clinicians. The research team, which has studied 21 healthcare sites of various sizes over the past 12 years, believes this site is an excellent example of an organization which is using a commercially available electronic-health-record system with CDS well. The eight-dimensional model proved useful as an organizing structure for the evaluation.

Larry Weed, MD is widely known as the father of the problem-oriented medical record and inventor of the now-ubiquitous SOAP (subjective/objective/assessment/ plan) note, for developing an electronic health record system (Problem-Oriented Medical Information System, PROMIS), and for founding a company (since acquired), which developed problem-knowledge couplers. However, Dr Weed's vision for medicine goes far beyond software —over the course of his storied career, he has relentlessly sought to bring the scientific method to medical practice and, where necessary, to point out shortcomings in the system and advocate for change. In this oral history, Dr Weed describes, in his own words, the arcs of his long career and the work that remains to be done.

Transesophageal color flow Doppler findings were studied in 30 patients with aortic insufficiency who had cardiac operations. Measurements were expressed as ratios of corresponding left ventricular outflow tract dimensions. Regurgitant jet proximal width ratio was significantly related to jet area ratio (r = 0.92) and correlated poorly with the degree of jet penetration into the left ventricular cavity (r = 0.32). The vectors of the regurgitant jets were variable. Nine patients had undergone aortography. Regurgitant jet proximal width and area ratios were significantly related to angiographic grade (r = 0.88 and 0.87, respectively) in these patients. We concluded that the esophagus offers a satisfactory transducer orientation for color flow Doppler assessment of aortic insufficiency.

The pervasive use of electronic records in healthcare increases the dependency on technology due to the lack of physical backup for the records. Downtime in the Electronic Health Record system is unavoidable, due to software, infrastructure and power failures as well as natural disasters, so there is a need to develop a contingency plan ensuring patient care continuity and minimizing risks for health care delivery. To mitigate these risks, two applications were developed allowing healthcare delivery providers to retrieve clinical information using the Clinical Document Architecture Release 2 (CDA R2) document repository as the information source. In this paper we describe the strategy, implementation and results; and provide an evaluation of effectiveness.

We have identified 5 use cases that comprise a useful definition of an "open or interoperable electronic health record (EHR)." Each of these use cases represents important functionality that should be available to 1) clinicians, so they can provide safe and effective health care; 2) researchers, so they can advance our understanding of disease and health care processes; 3) administrators, so they can reduce their reliance on a single-source EHR developer; 4) software developers, so they can develop innovative solutions to address limitations of current EHR user interfaces and new applications to improve the practice of medicine; and 5) patients, so they can access their personal health information no matter where they receive their health care. Widespread access to "open EHRs" that can accommodate at least these 5 use cases is important if we are to realize the enormous potential of EHR-enabled health care systems.

We developed the Biomedical Informatics Researchers ranking website (rank.informatics-review.com) to overcome many of the limitations of previous scientific productivity ranking strategies. The website is composed of four key components that work together to create an automatically updating ranking website: (1) list of biomedical informatics researchers, (2) Google Scholar scraper, (3) display page, and (4) updater. The site has been useful to other groups in evaluating researchers, such as tenure and promotions committees in interpreting the various citation statistics reported by candidates. Creation of the Biomedical Informatics Researchers ranking website highlights the vast differences in scholarly productivity among members of the biomedical informatics research community.

To identify challenges, lessons learned and best practices for service-oriented clinical decision support, based on the results of the Clinical Decision Support Consortium, a multi-site study which developed, implemented and evaluated clinical decision support services in a diverse range of electronic health records. Ethnographic investigation using the rapid assessment process, a procedure for agile qualitative data collection and analysis, including clinical observation, system demonstrations and analysis and 91 interviews. We identified challenges and lessons learned in eight dimensions: (1) hardware and software computing infrastructure, (2) clinical content, (3) human-computer interface, (4) people, (5) workflow and communication, (6) internal organizational policies, procedures, environment and culture, (7) external rules, regulations, and pressures and (8) system measurement and monitoring. Key challenges included performance issues (particularly related to data retrieval), differences in terminologies used across sites, workflow variability and the need for a legal framework. Based on the challenges and lessons learned, we identified eight best practices for developers and implementers of service-oriented clinical decision support: (1) optimize performance, or make asynchronous calls, (2) be liberal in what you accept (particularly for terminology), (3) foster clinical transparency, (4) develop a legal framework, (5) support a flexible front-end, (6) dedicate human resources, (7) support peer-to-peer communication, (8) improve standards. The Clinical Decision Support Consortium successfully developed a clinical decision support service and implemented it in four different electronic health records and four diverse clinical sites; however, the process was arduous. The lessons identified by the Consortium may be useful for other developers and implementers of clinical decision support services.

Electronic health records (EHRs) have potential to improve quality and safety of healthcare. However, EHR users have experienced safety concerns from EHR design and usability features that are not optimally adapted for the complex work flow of real-world practice. Few strategies exist to address unintended consequences from implementation of EHRs and other health information technologies. We propose that organizations equipped with EHRs should consider the strategy of “proactive risk assessment” of their EHR-enabled healthcare system to identify and address EHR-related safety concerns. In this paper, we describe the conceptual underpinning of an EHR-related self-assessment strategy to provide institutions a foundation upon which they could build their safety efforts. With support from the Office of the National Coordinator for Health Information Technology (ONC), we used a rigorous, iterative process to develop a set of 9 self-assessment tools to optimize the safety and safe use of ...

When truly significant scientific challenges are overcome, it profoundly changes the daily activities, as well as the future research activities, of everyone involved in the related field. By identifying and describing the grand challenges facing a scientific field, we can help funding agencies identify and prioritize projects for support, stimulate and encourage new investigators to work on these intellectual and

The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human-computer interfaces), the interaction of technology with non-technological factors...

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 conside...

Clinical decision support (CDS) is essential for delivery of high-quality, cost-effective, and safe healthcare. The authors sought to evaluate the CDS capabilities across electronic health record (EHR) systems. We evaluated the CDS implementation capabilities of 8 Office of the National Coordinator for Health Information Technology Authorized Certification Body (ONC-ACB)-certified EHRs. Within each EHR, the authors attempted to implement 3 user-defined rules that utilized the various data and logic elements expected of typical EHRs and that represented clinically important evidenced-based care. The rules were: 1) if a patient has amiodarone on his or her active medication list and does not have a thyroid-stimulating hormone (TSH) result recorded in the last 12 months, suggest ordering a TSH; 2) if a patient has a hemoglobin A1c result >7% and does not have diabetes on his or her problem list, suggest adding diabetes to the problem list; and 3) if a patient has coronary artery dis...

Electronic health record systems (EHRs) can improve safety and reliability of health care, but they can also introduce new vulnerabilities by failing to accommodate changes within a dynamic EHR-enabled health care system. Continuous assessment and improvement is thus essential for achieving resilience in EHR-enabled health care systems. Given the rapid adoption of EHRs by many organizations that are still early in their experiences with EHR safety, it is important to understand practices for maintaining resilience used by organizations with a track record of success in EHR use. We conducted interviews about safety practices with 56 key informants (including information technology managers, chief medical information officers, physicians, and patient safety officers) at two large health care systems recognized as leaders in EHR use. We identified 156 references to resilience-related practices from 41 informants. Framework analysis generated five categories of resilient practices: (a) ...

Suboptimal care at the end-of-life can be due to lack of access or knowledge of patient wishes. Ambiguity is often the result of non-standardized formats. Borrowing digital technology from other industries and using existing health information infrastructure can greatly improve the completion, storage, and distribution of advance directives. We believe several simple, low-cost adaptations to regional and federal programs can raise the standard of end-of-life care.

The field of clinical informatics has expanded substantially in the six decades since its inception. Early research focused on simple demonstrations that health information technology (HIT) such as electronic health records (EHRs), computerized provider order entry (CPOE), and clinical decision support (CDS) systems were feasible and potentially beneficial in clinical practice. In this review, we present recent evidence on clinical informatics in the United States covering three themes: 1) clinical informatics systems and interventions for providers, including EHRs, CPOE, CDS, and health information exchange; 2) consumer health informatics systems, including personal health records and web-based and mobile HIT; and 3) methods and governance for clinical informatics, including EHR usability; data mining, text mining, natural language processing, privacy, and security. Substantial progress has been made in demonstrating that various clinical informatics methodologies and applications ...