An analysis of electronic health record-related patient safety concerns

Derek W Meeks, Michael W Smith, Lesley Taylor, Dean F Sittig, Jean M Scott, Hardeep Singh, Derek W Meeks, Michael W Smith, Lesley Taylor, Dean F Sittig, Jean M Scott, Hardeep Singh

Abstract

Objective: A recent Institute of Medicine report called for attention to safety issues related to electronic health records (EHRs). We analyzed EHR-related safety concerns reported within a large, integrated healthcare system.

Methods: The Informatics Patient Safety Office of the Veterans Health Administration (VA) maintains a non-punitive, voluntary reporting system to collect and investigate EHR-related safety concerns (ie, adverse events, potential events, and near misses). We analyzed completed investigations using an eight-dimension sociotechnical conceptual model that accounted for both technical and non-technical dimensions of safety. Using the framework analysis approach to qualitative data, we identified emergent and recurring safety concerns common to multiple reports.

Results: We extracted 100 consecutive, unique, closed investigations between August 2009 and May 2013 from 344 reported incidents. Seventy-four involved unsafe technology and 25 involved unsafe use of technology. A majority (70%) involved two or more model dimensions. Most often, non-technical dimensions such as workflow, policies, and personnel interacted in a complex fashion with technical dimensions such as software/hardware, content, and user interface to produce safety concerns. Most (94%) safety concerns related to either unmet data-display needs in the EHR (ie, displayed information available to the end user failed to reduce uncertainty or led to increased potential for patient harm), software upgrades or modifications, data transmission between components of the EHR, or 'hidden dependencies' within the EHR.

Discussion: EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after 'go-live' and despite the sophisticated EHR infrastructure represented in our data source. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA.

Conclusions: Because EHR-related safety concerns have complex sociotechnical origins, institutions with long-standing as well as recent EHR implementations should build a robust infrastructure to monitor and learn from them.

Keywords: Electronic Health Records; human factors; medical errors; patients safety; reporting systems; sociotechnical.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

References

    1. Institute of Medicine (IOM). Crossing the quality chasm a new health system for the 21st century. The National Academy Press, 2001
    1. Sittig DF, Singh H. Legal, ethical, and financial dilemmas in electronic health record adoption and use. Pediatrics 2011;127:e1042–7
    1. Ash JS, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Med Inform Assoc 2004;11:104–12
    1. Balka E, Doyle-Waters M, Lecznarowicz D, et al. . Technology, governance and patient safety: systems issues in technology and patient safety. Int J Med Inform 2007;76(Suppl 1):S35–47
    1. Bates W, Cohen M, Leape L, et al. . Reducing the frequency of errors in medicine using information technology. J Am Med Inform Assoc 2001;8:299–308
    1. Coleman RW. Translation and interpretation: the hidden processes and problems revealed by computerized physician order entry systems. J Crit Care 2004;19:279–82
    1. Hundt AS, Adams JA, Schmid JA, et al. . Conducting an efficient proactive risk assessment prior to CPOE implementation in an intensive care unit. Int J Med Inform 2013;82:25–38
    1. Patterson ES, Cook RI, Render ML. Improving patient safety by identifying side effects from introducing bar coding in medication administration. J Am Med Inform Assoc 2002;9:540–53
    1. Pirnejad H, Niazkhani Z, van der SH, et al. . Impact of a computerized physician order entry system on nurse-physician collaboration in the medication process. Int J Med Inform 2008;77:735–44
    1. Fairbanks RJ, Wears RL. Hazards with medical devices: the role of design. Ann Emerg Med 2008;52:519–21
    1. Karsh BT, Weinger MB, Abbott PA, et al. . Health information technology: fallacies and sober realities. J Am Med Inform Assoc 2010;17:617–23
    1. Institute of Medicine (IOM). Health IT and Patient Safety: Building Safer Systems for Safer Care. Washington, DC: The National Academies Press, 2012
    1. Middleton B, Bloomrosen M, Dente MA, et al. . Enhancing patient safety and quality of care by improving the usability of electronic health record systems: recommendations from AMIA. J Am Med Inform Assoc 2013;20:e2–8
    1. Han YY, Carcillo JA, Venkataraman ST, et al. . Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system. Pediatrics 2005;116:1506–12
    1. Koppel R, Metlay JP, Cohen A, et al. . Role of computerized physician order entry systems in facilitating medication errors. JAMA 2005;293:1197–203
    1. Ash JS, Sittig DF, Poon EG, et al. . The extent and importance of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc 2007;14:415–23
    1. Singh H, Mani S, Espadas D, et al. . Prescription errors and outcomes related to inconsistent information transmitted through computerized order entry: a prospective study. Arch Intern Med 2009;169:982–9
    1. Myers RB, Jones SL, Sittig DF. Review of reported clinical information system adverse events in US food and drug administration databases. Appl Clin Inform 2011;2:63–74
    1. Weiner JP, Kfuri T, Chan K, et al. . “e-Iatrogenesis”: the most critical unintended consequence of CPOE and other HIT. J Am Med Inform Assoc 2007;14:387–8
    1. Harrington L, Kennerly D, Johnson C. Safety issues related to the electronic medical record (EMR): synthesis of the literature from the last decade, 2000–2009. J Healthc Manag 2011;56:31–43
    1. Meeks DW, Takian A, Sittig DF, et al. . Exploring the sociotechnical intersection of patient safety and electronic health record implementation. J Am Med Inform Assoc 2014;21(e1)e28–34.
    1. Veterans Health Administration. VHA National Patient Safety Improvement Handbook. Washington, DC, 2011. Report No.: VHA Handbook 1050.1
    1. Clancy CM. Common formats allow uniform collection and reporting of patient safety data by patient safety organizations. Am J Med Qual 2010;25:73–5
    1. Sittig DF, Singh H. A new sociotechnical model for studying health information technology in complex adaptive healthcare systems. Qual Saf Health Care 2010;19(Suppl 3):i68–74
    1. Harrison MI, Koppel R, Bar-Lev S. Unintended consequences of information technologies in health care—an interactive sociotechnical analysis. J Am Med Inform Assoc 2007;14:542–9
    1. Harrison MI, Henriksen K, Hughes RG. Improving the health care work environment: a sociotechnical systems approach. Jt Comm J Qual Patient Saf 2007;33(11 Suppl):3–6, 1
    1. Carayon P, Schoofs Hundt A, Karsh BT, et al. . Work system design for patient safety: the SEIPS model. Quality and Safety in Health Care 2006;15(suppl 1):i50–8
    1. Health Information Technology Safety Action & Surveillance Plan. The Office for the National Coordinator of Health Information Technology 2013 July 2 [cited 2013 Jul 11];
    1. Magrabi F, Ong MS, Runciman W, et al. . Using FDA reports to inform a classification for health information technology safety problems. J Am Med Inform Assoc 2012;19:45–53
    1. Magrabi F, Ong MS, Runciman W, et al. . An analysis of computer-related patient safety incidents to inform the development of a classification. J Am Med Inform Assoc 2010;17:663–70
    1. Sparnon E, Marella WM. The role of the electronic health record in patient safety events. Harrisburg, PA: Pennsylvania Patient Safety Authority; 2012
    1. Henriksen K, Kaye R, Morisseau D. Industrial ergonomic factors in the radiation oncology therapy environment. Advances in Industrial Ergonomics and Safety V. Taylor and Francis 1993;325
    1. Charles V, Sally T, Nicola S. Framework for analysing risk and safety in clinical medicine. BMJ 1998;316
    1. Sittig DF, Singh H. Defining health information technology-related errors: new developments since to err is human. Arch Intern Med 2011;171:1281–4
    1. Singh H, Wilson L, Petersen LA, et al. . Improving follow-up of abnormal cancer screens using electronic health records: trust but verify test result communication. BMC Med Inform Decis Mak 2009;9:49.
    1. Singh H, Thomas EJ, Sittig DF, et al. . Notification of abnormal lab test results in an electronic medical record: do any safety concerns remain? Am J Med 2010;123:238–44
    1. U.S. Department of Veterans Affairs. About VHA. 2014 [cited 2014 Jan 15].
    1. Brown SH, Lincoln MJ, Groen PJ, et al. . VistA-U.S. department of veterans affairs national-scale HIS. Int J Med Inform 2003;69:135–56
    1. Spetz J, Burgess JF, Phibbs CS. What determines successful implementation of inpatient information technology systems? Am J Manag Care 2012;18:157–62
    1. Perlin JB, Kolodner RM, Roswell RH. The veterans health administration: quality, value, accountability, and information as transforming strategies for patient-centered care. Am J Manag Care 2004;10:828–36
    1. Bonner LM, Simons CE, Parker LE, et al. . ‘To take care of the patients’: qualitative analysis of veterans health administration personnel experiences with a clinical informatics system. Implement Sci 2010;5:63.
    1. Taylor L, Wood SD, Chapman R. Analysis and Mitigation of Reported Informatics Patient Safety Adverse Events at the Veterans Health Administration. Human Factors and Ergonomics Society, 2012
    1. McCoy AB, Wright A, Kahn MG, et al. . Matching identifiers in electronic health records: implications for duplicate records and patient safety. BMJ Quality & Safety 2013;22:219–24
    1. Graber ML, Franklin N, Gordon R. Diagnostic error in internal medicine. Arch Intern Med 2005;165:1493–9
    1. Green J, Thorogood N. Qualitative methods for health research. Introducing qualitative methods. London: SAGE, 2004. p. xv, 262
    1. Pope C, Ziebland S, Mays N. Qualitative research in health care. Analysing qualitative data. BMJ 2000;320:114–16
    1. Gale N, Heath G, Cameron E, et al. . Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol 2013;13:117.
    1. Sittig DF, Singh H. Electronic health records and national patient-safety goals. N Engl J Med 2012;367:1854–60
    1. Reliability. In: Given LM. ed. The SAGE Encyclopedia of Qualitative Research Methods. 2nd ed. Thousand Oaks, CA: SAGE Publications; 2008:753–4
    1. Brodie ML, Stonebraker M. Migrating legacy systems: gateways, interfaces & the incremental approach. Morgan Kaufmann Publishers Inc., 1995
    1. Sittig DF, Teich JM, Yungton JA, et al. . Preserving context in a multi-tasking clinical environment: a pilot implementation. Proc AMIA Annu Fall Symp 1997; 784–8
    1. Patterson ES, Roth EM, Woods DD. Facets of complexity in situated work. Macrocognition Metrics and Scenarios: Design and Evaluation for Real-World Teams Ashgate Publishing ISBN, 2010:978
    1. Singh H, Ash J, Sittig D. Safety assurance factors for electronic health record resilience (SAFER): study protocol. BMC Med Inform Decis Mak 2013;13:46.
    1. Wright A, Henkin S, Feblowitz J, et al. . Early results of the meaningful use program for electronic health records. N Engl J Med 2013;368:779–80
    1. Warm D, Edwards P. Classifying health information technology patient safety related incidents—an approach used in Wales. Appl Clin Inform 2012;3:248–57
    1. Holden RJ, Karsh BT. A review of medical error reporting system design considerations and a proposed cross-level systems research framework. Hum Factors 2007;49:257–76
    1. The Office of the National Coordinator for Health Information Technology. SAFER Guides. 2014 [cited 2014 Apr 10].
    1. Sittig DF, Ash JS, Singh H. ONC issues guides for SAFER EHRs. J AHIMA 2014;50–2
    1. Sari AB-A, Trevor AS, Alison C, et al. . Sensitivity of routine system for reporting patient safety incidents in an NHS hospital: retrospective patient case note review. BMJ 2007;334
    1. Brubacher JR, Hunte GS, Hamilton L, et al. . Barriers to and incentives for safety event reporting in emergency departments. Healthc Q 2011;14:57–65

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe