Home LiteratureArticle Details
PMID: 22080284 Published · ppublish English Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Creating an oversight infrastructure for electronic health record-related patient safety hazards.

Journal of patient safety ·Vol. 7 ·No. 4 ·2011-12-00 ·Pages 169-74

Singh H, Classen DC, Sittig DF

Abstract

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.

MeSH Terms
Data Collection Electronic Health Records/legislation & jurisprudence,organization & administration Government Regulation Health Policy Humans National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division Patient Care Population Surveillance Program Development Program Evaluation Safety Management/legislation & jurisprudence,methods,organization & administration United States United States Department of Veterans Affairs
Authors & Affiliations
3 authors, click to expand affiliations / ORCID
Singh Hardeep
Houston VA Health Services Research and Development Center of Excellence, Texas, USA.
Classen David C
Sittig Dean F
References (47)
47 references, click to expand
  1. Computerized physician order entry of injectable antineoplastic drugs: an epidemiologic study of prescribing medication errors.
    Int J Med Inform. 2010 Oct;79(10):699-706 PMID: 20829102
  2. A replicable method for blood glucose control in critically Ill patients.
    Crit Care Med. 2008 Jun;36(6):1787-95 PMID: 18520641
  3. Improving follow-up of abnormal cancer screens using electronic health records: trust but verify test result communication.
    BMC Med Inform Decis Mak. 2009 Dec 09;9:49 PMID: 20003236
  4. Partnering to improve hospital-physician office communication through implementing care transitions best practices.
    Med Health R I. 2011 Jun;94(6):178-82 PMID: 21748988
  5. Using FDA reports to inform a classification for health information technology safety problems.
    J Am Med Inform Assoc. 2012 Jan-Feb;19(1):45-53 PMID: 21903979
  6. Computers in critical care.
    Crit Care Nurs Clin North Am. 1995 Jun;7(2):203-17 PMID: 7619363
  7. A randomized trial of "corollary orders" to prevent errors of omission.
    J Am Med Inform Assoc. 1997 Sep-Oct;4(5):364-75 PMID: 9292842
  8. Cognitive and usability engineering methods for the evaluation of clinical information systems.
    J Biomed Inform. 2004 Feb;37(1):56-76 PMID: 15016386
  9. Developing the Sentinel System--a national resource for evidence development.
    N Engl J Med. 2011 Feb 10;364(6):498-9 PMID: 21226658
  10. Recommendations for responsible monitoring and regulation of clinical software systems. American Medical Informatics Association, Computer-based Patient Record Institute, Medical Library Association, Association of Academic Health Science Libraries, American Health Information Management Association, American Nurses Association.
    J Am Med Inform Assoc. 1997 Nov-Dec;4(6):442-57 PMID: 9391932
  11. Defining health information technology-related errors: new developments since to err is human.
    Arch Intern Med. 2011 Jul 25;171(14):1281-4 PMID: 21788544
  12. Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force.
    J Am Med Inform Assoc. 2011 Jan-Feb;18(1):77-81 PMID: 21075789
  13. Computer crash--lessons from a system failure.
    N Engl J Med. 2003 Mar 6;348(10):881-2 PMID: 12621131
  14. Hurricane Katrina. Scientists' fears come true as hurricane floods New Orleans.
    Science. 2005 Sep 9;309(5741):1656-9 PMID: 16150980
  15. EHR safety: the way forward to safe and effective systems.
    J Am Med Inform Assoc. 2008 May-Jun;15(3):272-7 PMID: 18308981
  16. Development of the Leapfrog methodology for evaluating hospital implemented inpatient computerized physician order entry systems.
    Qual Saf Health Care. 2006 Apr;15(2):81-4 PMID: 16585104
  17. Establishment of the permanent certification program for health information technology. Final rule.
    Fed Regist. 2011 Jan 7;76(5):1261-331 PMID: 21261128
  18. Downtime procedures for a clinical information system: a critical issue.
    J Crit Care. 2007 Mar;22(1):45-50 PMID: 17371746
  19. The "meaningful use" regulation for electronic health records.
    N Engl J Med. 2010 Aug 5;363(6):501-4 PMID: 20647183
  20. Eight rights of safe electronic health record use.
    JAMA. 2009 Sep 9;302(10):1111-3 PMID: 19738098
  21. Health care information technology vendors' "hold harmless" clause: implications for patients and clinicians.
    JAMA. 2009 Mar 25;301(12):1276-8 PMID: 19318655
  22. Safety issues related to the electronic medical record (EMR): synthesis of the literature from the last decade, 2000-2009.
    J Healthc Manag. 2011 Jan-Feb;56(1):31-43; discussion 43-4 PMID: 21323026
  23. Comprehensive analysis of a medication dosing error related to CPOE.
    J Am Med Inform Assoc. 2005 Jul-Aug;12(4):377-82 PMID: 15802485
  24. Role of computerized physician order entry systems in facilitating medication errors.
    JAMA. 2005 Mar 9;293(10):1197-203 PMID: 15755942
  25. Clinical decision support in small community practice settings: a case study.
    J Am Med Inform Assoc. 2011 Nov-Dec;18(6):879-82 PMID: 21504995
  26. A risk analysis method to evaluate the impact of a computerized provider order entry system on patient safety.
    J Am Med Inform Assoc. 2008 Jul-Aug;15(4):453-60 PMID: 18436900
  27. Toward a statewide health information technology center (abbreviated version).
    South Med J. 2010 Nov;103(11):1111-4 PMID: 20890248
  28. Mixed results in the safety performance of computerized physician order entry.
    Health Aff (Millwood). 2010 Apr;29(4):655-63 PMID: 20368595
  29. Computer protocol facilitates evidence-based care of sepsis in the surgical intensive care unit.
    J Trauma. 2011 May;70(5):1153-66; discussion 1166-7 PMID: 21610430
  30. Unintended errors with EHR-based result management: a case series.
    J Am Med Inform Assoc. 2010 Jan-Feb;17(1):104-7 PMID: 20064810
  31. Using health care Failure Mode and Effect Analysis: the VA National Center for Patient Safety's prospective risk analysis system.
    Jt Comm J Qual Improv. 2002 May;28(5):248-67, 209 PMID: 12053459
  32. Overdependence on technology: an unintended adverse consequence of computerized provider order entry.
    AMIA Annu Symp Proc. 2007 Oct 11;:94-8 PMID: 18693805
  33. Health information technology: initial set of standards, implementation specifications, and certification criteria for electronic health record technology. Final rule.
    Fed Regist. 2010 Jul 28;75(144):44589-654 PMID: 20677416
  34. The informatics opportunities at the intersection of patient safety and clinical informatics.
    J Am Med Inform Assoc. 2008 Jul-Aug;15(4):397-407 PMID: 18436896
  35. Human error: models and management.
    BMJ. 2000 Mar 18;320(7237):768-70 PMID: 10720363
  36. Recommendations for monitoring and evaluation of in-patient Computer-based Provider Order Entry systems: results of a Delphi survey.
    AMIA Annu Symp Proc. 2007 Oct 11;:671-5 PMID: 18693921
  37. Safe electronic health record use requires a comprehensive monitoring and evaluation framework.
    JAMA. 2010 Feb 3;303(5):450-1 PMID: 20124542
  38. Lessons from "Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system".
    Pediatrics. 2006 Aug;118(2):797-801 PMID: 16882838
  39. Review of Reported Clinical Information System Adverse Events in US Food and Drug Administration Databases.
    Appl Clin Inform. 2011;2(1):63-74 PMID: 21938265
  40. 'Global trigger tool' shows that adverse events in hospitals may be ten times greater than previously measured.
    Health Aff (Millwood). 2011 Apr;30(4):581-9 PMID: 21471476
  41. Reducing health care hazards: lessons from the commercial aviation safety team.
    Health Aff (Millwood). 2009 May-Jun;28(3):w479-89 PMID: 19351647
  42. Identifying and quantifying medication errors: evaluation of rapidly discontinued medication orders submitted to a computerized physician order entry system.
    J Am Med Inform Assoc. 2008 Jul-Aug;15(4):461-5 PMID: 18436910
  43. Computerization can create safety hazards: a bar-coding near miss.
    Ann Intern Med. 2006 Apr 4;144(7):510-6 PMID: 16585665
  44. Monitoring and evaluating the use of electronic health records.
    JAMA. 2010 May 19;303(19):1918; author reply 1918-9 PMID: 20483967
  45. The regional extension center program: helping physicians meaningfully use health information technology.
    Ann Intern Med. 2010 Nov 16;153(10):666-70 PMID: 21079224
  46. An analysis of computer-related patient safety incidents to inform the development of a classification.
    J Am Med Inform Assoc. 2010 Nov-Dec;17(6):663-70 PMID: 20962128
  47. A simulation framework for mapping risks in clinical processes: the case of in-patient transfers.
    J Am Med Inform Assoc. 2011 May 1;18(3):259-66 PMID: 21486883
Article Info
Journal
Journal of patient safety
Abbr.
J Patient Saf
ISSN
1549-8425
Published
2011-12-00
Pages
169-74
Language
English
Region
United States
NLM ID
101233393
PMCID
PMC3677059
Subset
IM
Grants
NCI NIH HHS · K23 CA125585 · United States
NLM NIH HHS · R01 LM006942 · United States
NCI NIH HHS · K23CA125585 · United States
NLM NIH HHS · R01-LM006942 · United States
Analysis Services
Analysis Services

Contact

No. 2 Wenbo Road, Zhangqiu District, Jinan, Shandong

Qilu Normal University · Genelibs Bioinformatics Lab

750 Shunhua Rd, Jinan

2F, Bldg F, University Science Park

Tel: 0531-88819269

WeChat Official Account

Follow our WeChat subscription account for real-time updates and the latest in medical and biological research.


Business Email

E-mail: [email protected]