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Appendix C Abstract of “Roadmap for Provision of Safer Healthcare Information Systems: Preventing e-Iatrogenesis” 1 Joan S. Ash, Ph.D., M.L.S., M.B.A.; Charles M. Kilo, M.D., M.P.H.; Michael Shapiro, M.A., M.S.; Joseph Wasserman, B.A.; Carmit McMullen, Ph.D.; William Hersh, M.D. BACKGROUND AND METHODS e-Iatrogenesis, defined as “patient harm caused at least in part by the application of health information technology” (Weiner et al., 2007), is of increasing concern as more and more hospitals are implementing health information systems (HIS). This report assesses how HIS can be designed, developed, implemented, monitored, and maintained to maximize safety. We specifically focus on hospital electronic health records (EHRs), clinical deci- sion support (CDS), and computerized provider order entry (CPOE) systems. This white paper is intended to provide background for an Institute of Medi- cine (IOM) report on how the use of health information technology affects the safety of patient care by answering the following IOM-posed questions: • What are the risks of health care information systems that arise from workflow and related issues? • How have organizations acted to implement health care informa- tion systems safely? • What are the impacts of customization on safety? • What is the industry approach to managing change and customization? A recent literature review by Harrington et al. (2011) has summarized the EHR safety literature, so we first reviewed all papers cited in their 1 Full commissioned paper is included on the CD in the back of the book. 185
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186 HEALTH IT AND PATIENT SAFETY report. Of their 43 references, we identified 37 that were relevant to the scope of this article. We analyzed the bibliographies of these selected papers and performed a reverse bibliography search on the articles deemed most relevant and published since 2000. In total, we identified more than 100 sources relevant to the scope of this report. We then targeted topics for which published evidence was lacking and conducted several interviews with experts to help fill the knowledge gaps. RESULTS What Are the Risks of Health Information Systems That Arise from Workflow and Related Issues? We found seven publications (Chuo and Hicks, 2008; Joint Commis- sion on Accreditation of Healthcare Organizations, 2008; Magrabi et al., 2010; Myers et al., 2011; Santell et al., 2009; Walsh et al., 2006; Zhan et al., 2006) presenting results of assessments of e-iatrogenic risk. All are stud- ies of large databases of reported errors, and they consistently indicate low levels of HIS-related risk, less than 1 percent of all errors. All point to the need for human diligence when using HIS. Specifically, they indicate that HIS-related errors are due to inadequate staffing levels, lack of user experi- ence, mislabeled bar-codes on medications, human distraction, inaccurate data entry, system downtime, and missing data. How Have Organizations Acted to Implement Health Information Systems Safely? Prior to implementation, health care organizations can mitigate risk. There is a large literature base devoted to the risks inherent in commercial EHR systems, and also warnings about their impact on workflow. Many publications offer guidance to hospitals about assessing workflow, select- ing systems for purchase, conducting simulation tests, training, and other mechanisms for ensuring safe HIS implementation. Numerous publications exist to guide the implementation process itself, but there are also several pointing to the risks of rapid implementation without appropriate prepa- ration. Finally, after implementation, continuous monitoring and improve- ment can mitigate safety risks. What Are the Impacts of Customization on Safety? The literature indicates that customization of the EHR to fit local situ- ations seems to be necessary for many reasons, but there is scant research on how much customization or what form of customization is needed to
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187 APPENDIX C optimize EHR use and what the risks are from either too much or too little customization. The content of CDS likewise needs adaptation, especially to avoid alert fatigue. Any customization must be done with care so that system upgrades can be accommodated. What Is the Industry Approach to Managing Change and Customization? The current industry approach is fragmented; a report sponsored by the Agency for Healthcare Research and Quality describes a wide variety of vendor practices related to usability of systems (McDonnell et al., 2010). Because purchasers must usually customize systems to fit local workflows and regulations, HIS safety depends on a combination of industry and local diligence. RECOMMENDATIONS Although current evidence is limited, the presence of HIS appears to contribute to less than 1 percent of total errors in health care settings. How- ever, indirect effects from disruption of workflow are difficult to measure. Further investigation into these issues is needed as soon as possible so that solid evidence can inform the bolus of HIS implementations in hospitals resulting from meaningful use regulations. In addition, expert consensus- based recommendations would be highly useful. REFERENCES Chuo, J., and R. W. Hicks. 2008. Computer-related medication errors in neonatal intensive care units. Clinics in Perinatology 35:119-139. Joint Commission on Accreditation of Healthcare Organizations. 2008. Safely implementing health information and converging technologies. Sentinel Event Alert 42:1-4. Harrington, L., D. Kennerly, and C. Johnson. 2011. Safety issues related to the electronic medical record (EMR): Synthesis of the literature from the last decade, 2000–2009. Journal of Healthcare Management 56(1):31-44. Magrabi, F., M.-S. Ong, W. Runciman, and E. Coiera. 2010. An analysis of computer-related patient safety incidents to inform the development of a classification. Journal of the American Medical Informatics Association 17:663-670. McDonnell, C., K. Werner, and L. Wendel. May, 2010. Electronic health record usability: Vendor practices and perspectives. AHRQ Publication No. 09(10)-0091-3-EF. Rockville, MD: Agency for Healthcare Research and Quality. Myers, R. B., S. L. Jones, and D. F. Sittig. 2011. Review of reported clinical information sys- tem adverse events in U.S. Food and Drug Administration databases. Applied Clinical Informatics 2:63-74. Santell, J. P., J. G. Kowiatek, R. J. Weber, R. W. Hicks, and C. A. Sirio. 2009. Medication errors resulting from computer entry by nonprescribers. American Journal of Health- System Pharmacists 66:843-853.
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188 HEALTH IT AND PATIENT SAFETY Walsh, K. E., W. G. Adams, H. Bauchner, R. J. Vinci, J. B. Chessare, M. R. Cooper, P. M. Hebert, E. G. Schainker, and C. P. Landrigan. 2006. Medication errors related to com- puterized order entry for children. Pediatrics 118(5):1872-1879. Weiner, J. P., T. Kfuri, K. Chan, and J. B. Fowles. 2007. “E-iatrogenesis”: The most critical unintended consequence of CPOE and other HIT. Journal of the American Medical Informatics Association 14(3):387-388. Zhan, C., R. W. Hicks, C. M. Blanchette, M. A. Keyes, and D. D. Cousins. 2006. Potential benefits and problems with computerized prescriber order entry: Analysis of a voluntary medication error-reporting database. American Journal of Health-System Pharmacists 63:353-358.