AACN Advanced Critical Care Volume 25, Number 2, pp. 91–93 © 2014 AACN
Technology Today
Linda Harrington, RN-BC, PhD, DNP, CNS, CPHQ, CENP, CPHIMS Department Editor
Health Information Technology Safety: The Perfect Storms Linda Harrington, RN-BC, PhD, DNP, CNS, CPHQ, CENP, CPHIMS
T
hroughout history, significant innovations have been associated with new perils. The discovery of fire significantly advanced the global migration of people, allowing them to move to and survive in colder climates and for long periods of time. Fire also brought about the destruction of crops and housing structures as well as injury and death to people and animals. Similarly, cars and planes greatly enhanced the mobility of people and goods but also generated new modes of accidents, injury, and death. This Technology Today article examines the innovation of health information technology (HIT) and the accompanying improvements focused on increasing safety issues. It also introduces a convergence of factors that create HIT-enabled perfect storms. Background Health information technologies are, in part, intended to remove safety risks and minimize hazards in health care. Enhanced safety being realized as a result of HIT includes elimination of illegibility issues in paper medical records, greater and more ready access to information, assistance with calculations, better care coordination, and clinical decision support. Despite these benefits, unintended consequences of HIT use occur.1 The realization of safety risks associated with HIT is not new. In 2000, the Institute of Medicine’s Committee on Quality of Health Care in America released a seminal report titled “To Err Is Human: Building a Safer Health System.”2 In this report, the authors asserted that latent errors, such as those hidden in complex HIT applications, pose the greatest threat to safety in a complex system such as health care because they are difficult for end users to see and can lead to multiple types of active errors. Shortly thereafter, another landmark study described anecdotal evidence that although electronic medical records and associated clinical information systems can reduce errors, they also can cause errors.3 Examples provided included the wrong selection from 2 medications similarly spelled appearing in close proximity on the computer screen and physicians writing orders in the wrong electronic record. By 2007, sufficient evidence in the literature on HIT-related safety issues prompted Weiner and colleagues4 to coin the term e-iatrogenesis to denote patient harm resulting at least in part from HIT. The authors referred to e-iatrogenesis as the most critical unintended consequence of HIT and said that they coined the term to draw attention to this critical issue. Linda Harrington is Vice President and Chief Nursing Informatics Officer for Texas, Catholic Health Initiatives, Englewood, CO 80112 ([email protected]). The author declares no conflicts of interest. DOI: 10.1097/NCI.0000000000000022
91 Copyright © 2014 American Association of Critical-Care Nurses. Unauthorized reproduction of this article is prohibited.
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Technology Today
W W W .A A CNA D VA NCE D CRIT ICA LCA RE .COM
HIT-Enabled Perfect Storms A perfect storm is defined as a “critical or disastrous situation created by a concurrence of factors.”5 Four types of HIT-enabled perfect storms are emerging in health care.
HIT Perfect Storm: Type 4
The fourth type of perfect storm involves hardwiring of evidence-based or best practices in HIT, such as clinical decision support within electronic health records, patient teaching materials, and health care consumer websites. The potential consequences can affect a single patient, groups of patients, or large patient populations and include failure to receive appropriate treatment or the receipt of inappropriate treatment resulting in adverse events or death. One cause of type 4 has to do with selective reporting of scientific research. In a study on the selective publication of antidepressant trials, researchers examined Food and Drug Administration (FDA) studies involving 12 564 patients conducting a systematic literature search to identify matching publications.9 The researchers reported that among 74 FDA-registered studies, 31% were not published, further noting that how the studies were published was related to the study outcome. A total of 37 studies viewed by the FDA as having positive results were published, whereas 1 study viewed as positive was not published. A total of 22 studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published or published in a way that, in the researchers’ opinion, conveyed a positive outcome. The researchers concluded that the published literature made it appear that 94% of the antidepressant trials conducted were positive when only 51% actually were. Another recent study questions the use of β-blockers to prevent perioperative death in patients undergoing noncardiac surgery.10 A meta-analysis of 9 randomized controlled trials of 10 529 patients found that initiation of a course of β-blockers before surgery caused a 27% increase in risk for 30-day all-cause mortality. The researchers called for a retraction of all clinical practice guidelines recommending initiation of perioperative β-blockade in noncardiac surgeries. The increasing question of publication bias warrants caution when hardwiring clinical practices and assuming one-size-fits-all treatment approaches. Whether bias results from a failure to submit manuscripts, rejection of manuscripts, or both is unknown. What is known is that misinformation can cause harm.
HIT Perfect Storm: Type 1
The first type of perfect storm is created when 2 factors converge: implanted medical devices and mobile devices with magnets. An example would be the iPad with tiny magnets in the casing or cover left on the chests of patients with implanted medical devices such as defibrillators or pacemakers. The Apple 2010 product guide for the iPad recommends, based on the Health Industry Manufacturers Association, that the iPad be kept at least 6 inches from implanted pacemakers when the wireless device is turned on.6 A type 1 HIT perfect storm can occur in any location, and the potential consequences for individuals are injury or death. HIT Perfect Storm: Type 2
The second type of perfect storm occurs when software-controlled medical devices are exposed to the Internet, facing threats of cybersecurity, malware, and viruses. The result can be an impairment or disablement of the medical device and the potential for injury or death to patients in which the medical device is being used or is implanted. For example, on November 28, 2012, the Department of Homeland Security released a press release stating that pacemakers and other medical devices, including surgical and anesthesia devices, ventilators, drug infusion pumps, external defibrillators, patient monitors, and laboratory and analysis equipment, are potential targets for cybersecurity attacks and vulnerable to lethal cyberattacks.7 HIT Perfect Storm: Type 3
The third type of HIT-enabled perfect storm involves the so-called computer glitch, whereby a single error can have widespread consequences. An example includes Lifespan, a 5-hospital system in Rhode Island, which disclosed a prescription mixup that may have affected 2000 patients.8 The error was blamed on the software used to generate medication instructions to discharged patients, and no patient harm was thought to have occurred. Nonetheless, the potential exists for errors to be rapidly replicated inadvertently when electronically disseminated.
Take Action Safety risks associated with HIT are considered unique. Because of the large number of 92
Copyright © 2014 American Association of Critical-Care Nurses. Unauthorized reproduction of this article is prohibited.
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V OL UME 2 5 • N U MBER 2 • APRIL–JUNE 2014
Technology Today
patients in HIT systems, HIT-related errors have the potential to affect many patients.11 Proactive and preventive strategies are, therefore, imperative. The Office of the National Coordinator (ONC) for HIT, under the Department of Health and Human Services, released a patient safety and surveillance plan in 2013.12 The 2 objectives of the plan are to use HIT to make patient care safer and to continuously improve HIT safety. The plan details strategies and actions to achieve these objectives and should be used in health care organizations. In alignment with the ONC, the Centers for Medicare & Medicaid Services is encouraging the use of standardized reporting forms for HIT safety issues and training surveyors to identify unsafe HIT practices.13 Similarly, The Joint Commission, under a contract with the ONC, is investigating HIT-related adverse events, requiring the development of corrective-action plans, and creating a database of sentinel events for further research.14 Actions to ensure the safety of specific HITs are also under way. In January 2014, the ONC released the Safety Assurance Factors for EHR Resilience Guides.15 Each guide is composed of a self-assessment checklist and recommended practices for critical safety areas of electronic health records.
REFERENCES 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(2):104–112. 2. Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000. 3. Bates DW, Cohen M, Leape LL, Overhage JM, Shabot MM, Sheridan T. Reducing the frequency of errors in medicine using information technology. J Am Med Inform Assoc. 2001;8:299–308. 4. Weiner JP, Kfuri R, Chan K, Fowles JB. e-Iatrogenesis: the most critical unintended consequence of CPOE and other HIT. J Am Med Inform Assoc. 2007;14:387–388. 5. Merriam-Webster. Perfect storm. http://www.merriamwebster.com/dictionary/perfect%20storm. Accessed January 1, 2014. 6. Apple Inc. iPad: important product information guide. http://manuals.info.apple.com/en_US/iPad_Important_ Product_Information_Guide.pdf. Published 2010. 7. Homeland Security Newswire. Pacemakers, other implanted devices, vulnerable to lethal attacks. http://www. homelandsecuritynewswire.com/dr20121128-pacemakers-other-implanted-devices-vulnerable-to-lethal-attacks. Published November 28, 2012. 8. Forbes. Institute of Medicine slams sellers of electronic health records. http://www.forbes.com/sites/zinamoukheiber/2011/11/08/institute-of-medicine-slams-sellers-of-electronic-health-records/. Published November 8, 2011. 9. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252–260. 10. Bouri S, Shun-Shin MJ, Cole GD, Mayet J, Francis DP. Meta-analysis of secure randomized controlled trials of β-blockade to prevent perioperative death in non-cardiac surgery [published online ahead of print July 31, 2013]. Heart. doi:10.1136/hertjnl-2013-304262. 11. Sittig DF, Singh H. Defining health information technology– related errors. Arch Intern Med. 2011;171(14):1281–1284. 12. Office of the National Coordinator for Health Information Technology. Health Information Technology Patient Safety Action&Surveillance.http://www.healthit.gov/sites/default/ files/safety_plan_master.pdf. Published July 2, 2013. 13. US Department of Health & Human Services. Final HHS Health IT Safety Plan issue. http://www.hhs.gov/news/ press/2013pres/07/20130702a.html. Published July 2, 2013. 14. Modern Healthcare. Joint Commission puts focus on EHR, patient safety. http://www.modernhealthcare.com/ article/20130703/blog/307039936. Published July 3, 2103. 15. Office of the National Coordinator for Health Information Technology. Safer guides. http://www.healthit.gov/policyresearchers-implementers/safer. Published January 15, 2014. 16. Karsh BT, Weinger MB, Abbott PA, Wears RL. Health information technology: fallacies and sober realities. J Am Med Inform Assoc. 2010;17(6):617–623.
Conclusion Takeaways from this column should be clear. Although HIT can move the health care industry forward in terms of safety, quality, and value, it is not without risks.16 The keys are creating a culture of HIT safety while implementing and monitoring an HIT safety plan. Constant vigilance is required. Safety risks of HIT will continue to grow as more health care technologies are used and new technologies emerge.
93 Copyright © 2014 American Association of Critical-Care Nurses. Unauthorized reproduction of this article is prohibited.
NCI-D-14-00006.indd 93
17/04/14 9:41 PM
Technology Today
Linda Harrington, RN-BC, PhD, DNP, CNS, CPHQ, CENP, CPHIMS Department Editor
Health Information Technology Safety: The Perfect Storms Linda Harrington, RN-BC, PhD, DNP, CNS, CPHQ, CENP, CPHIMS
T
hroughout history, significant innovations have been associated with new perils. The discovery of fire significantly advanced the global migration of people, allowing them to move to and survive in colder climates and for long periods of time. Fire also brought about the destruction of crops and housing structures as well as injury and death to people and animals. Similarly, cars and planes greatly enhanced the mobility of people and goods but also generated new modes of accidents, injury, and death. This Technology Today article examines the innovation of health information technology (HIT) and the accompanying improvements focused on increasing safety issues. It also introduces a convergence of factors that create HIT-enabled perfect storms. Background Health information technologies are, in part, intended to remove safety risks and minimize hazards in health care. Enhanced safety being realized as a result of HIT includes elimination of illegibility issues in paper medical records, greater and more ready access to information, assistance with calculations, better care coordination, and clinical decision support. Despite these benefits, unintended consequences of HIT use occur.1 The realization of safety risks associated with HIT is not new. In 2000, the Institute of Medicine’s Committee on Quality of Health Care in America released a seminal report titled “To Err Is Human: Building a Safer Health System.”2 In this report, the authors asserted that latent errors, such as those hidden in complex HIT applications, pose the greatest threat to safety in a complex system such as health care because they are difficult for end users to see and can lead to multiple types of active errors. Shortly thereafter, another landmark study described anecdotal evidence that although electronic medical records and associated clinical information systems can reduce errors, they also can cause errors.3 Examples provided included the wrong selection from 2 medications similarly spelled appearing in close proximity on the computer screen and physicians writing orders in the wrong electronic record. By 2007, sufficient evidence in the literature on HIT-related safety issues prompted Weiner and colleagues4 to coin the term e-iatrogenesis to denote patient harm resulting at least in part from HIT. The authors referred to e-iatrogenesis as the most critical unintended consequence of HIT and said that they coined the term to draw attention to this critical issue. Linda Harrington is Vice President and Chief Nursing Informatics Officer for Texas, Catholic Health Initiatives, Englewood, CO 80112 ([email protected]). The author declares no conflicts of interest. DOI: 10.1097/NCI.0000000000000022
91 Copyright © 2014 American Association of Critical-Care Nurses. Unauthorized reproduction of this article is prohibited.
NCI-D-14-00006.indd 91
17/04/14 9:41 PM
Technology Today
W W W .A A CNA D VA NCE D CRIT ICA LCA RE .COM
HIT-Enabled Perfect Storms A perfect storm is defined as a “critical or disastrous situation created by a concurrence of factors.”5 Four types of HIT-enabled perfect storms are emerging in health care.
HIT Perfect Storm: Type 4
The fourth type of perfect storm involves hardwiring of evidence-based or best practices in HIT, such as clinical decision support within electronic health records, patient teaching materials, and health care consumer websites. The potential consequences can affect a single patient, groups of patients, or large patient populations and include failure to receive appropriate treatment or the receipt of inappropriate treatment resulting in adverse events or death. One cause of type 4 has to do with selective reporting of scientific research. In a study on the selective publication of antidepressant trials, researchers examined Food and Drug Administration (FDA) studies involving 12 564 patients conducting a systematic literature search to identify matching publications.9 The researchers reported that among 74 FDA-registered studies, 31% were not published, further noting that how the studies were published was related to the study outcome. A total of 37 studies viewed by the FDA as having positive results were published, whereas 1 study viewed as positive was not published. A total of 22 studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published or published in a way that, in the researchers’ opinion, conveyed a positive outcome. The researchers concluded that the published literature made it appear that 94% of the antidepressant trials conducted were positive when only 51% actually were. Another recent study questions the use of β-blockers to prevent perioperative death in patients undergoing noncardiac surgery.10 A meta-analysis of 9 randomized controlled trials of 10 529 patients found that initiation of a course of β-blockers before surgery caused a 27% increase in risk for 30-day all-cause mortality. The researchers called for a retraction of all clinical practice guidelines recommending initiation of perioperative β-blockade in noncardiac surgeries. The increasing question of publication bias warrants caution when hardwiring clinical practices and assuming one-size-fits-all treatment approaches. Whether bias results from a failure to submit manuscripts, rejection of manuscripts, or both is unknown. What is known is that misinformation can cause harm.
HIT Perfect Storm: Type 1
The first type of perfect storm is created when 2 factors converge: implanted medical devices and mobile devices with magnets. An example would be the iPad with tiny magnets in the casing or cover left on the chests of patients with implanted medical devices such as defibrillators or pacemakers. The Apple 2010 product guide for the iPad recommends, based on the Health Industry Manufacturers Association, that the iPad be kept at least 6 inches from implanted pacemakers when the wireless device is turned on.6 A type 1 HIT perfect storm can occur in any location, and the potential consequences for individuals are injury or death. HIT Perfect Storm: Type 2
The second type of perfect storm occurs when software-controlled medical devices are exposed to the Internet, facing threats of cybersecurity, malware, and viruses. The result can be an impairment or disablement of the medical device and the potential for injury or death to patients in which the medical device is being used or is implanted. For example, on November 28, 2012, the Department of Homeland Security released a press release stating that pacemakers and other medical devices, including surgical and anesthesia devices, ventilators, drug infusion pumps, external defibrillators, patient monitors, and laboratory and analysis equipment, are potential targets for cybersecurity attacks and vulnerable to lethal cyberattacks.7 HIT Perfect Storm: Type 3
The third type of HIT-enabled perfect storm involves the so-called computer glitch, whereby a single error can have widespread consequences. An example includes Lifespan, a 5-hospital system in Rhode Island, which disclosed a prescription mixup that may have affected 2000 patients.8 The error was blamed on the software used to generate medication instructions to discharged patients, and no patient harm was thought to have occurred. Nonetheless, the potential exists for errors to be rapidly replicated inadvertently when electronically disseminated.
Take Action Safety risks associated with HIT are considered unique. Because of the large number of 92
Copyright © 2014 American Association of Critical-Care Nurses. Unauthorized reproduction of this article is prohibited.
NCI-D-14-00006.indd 92
17/04/14 9:41 PM
V OL UME 2 5 • N U MBER 2 • APRIL–JUNE 2014
Technology Today
patients in HIT systems, HIT-related errors have the potential to affect many patients.11 Proactive and preventive strategies are, therefore, imperative. The Office of the National Coordinator (ONC) for HIT, under the Department of Health and Human Services, released a patient safety and surveillance plan in 2013.12 The 2 objectives of the plan are to use HIT to make patient care safer and to continuously improve HIT safety. The plan details strategies and actions to achieve these objectives and should be used in health care organizations. In alignment with the ONC, the Centers for Medicare & Medicaid Services is encouraging the use of standardized reporting forms for HIT safety issues and training surveyors to identify unsafe HIT practices.13 Similarly, The Joint Commission, under a contract with the ONC, is investigating HIT-related adverse events, requiring the development of corrective-action plans, and creating a database of sentinel events for further research.14 Actions to ensure the safety of specific HITs are also under way. In January 2014, the ONC released the Safety Assurance Factors for EHR Resilience Guides.15 Each guide is composed of a self-assessment checklist and recommended practices for critical safety areas of electronic health records.
REFERENCES 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(2):104–112. 2. Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000. 3. Bates DW, Cohen M, Leape LL, Overhage JM, Shabot MM, Sheridan T. Reducing the frequency of errors in medicine using information technology. J Am Med Inform Assoc. 2001;8:299–308. 4. Weiner JP, Kfuri R, Chan K, Fowles JB. e-Iatrogenesis: the most critical unintended consequence of CPOE and other HIT. J Am Med Inform Assoc. 2007;14:387–388. 5. Merriam-Webster. Perfect storm. http://www.merriamwebster.com/dictionary/perfect%20storm. Accessed January 1, 2014. 6. Apple Inc. iPad: important product information guide. http://manuals.info.apple.com/en_US/iPad_Important_ Product_Information_Guide.pdf. Published 2010. 7. Homeland Security Newswire. Pacemakers, other implanted devices, vulnerable to lethal attacks. http://www. homelandsecuritynewswire.com/dr20121128-pacemakers-other-implanted-devices-vulnerable-to-lethal-attacks. Published November 28, 2012. 8. Forbes. Institute of Medicine slams sellers of electronic health records. http://www.forbes.com/sites/zinamoukheiber/2011/11/08/institute-of-medicine-slams-sellers-of-electronic-health-records/. Published November 8, 2011. 9. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252–260. 10. Bouri S, Shun-Shin MJ, Cole GD, Mayet J, Francis DP. Meta-analysis of secure randomized controlled trials of β-blockade to prevent perioperative death in non-cardiac surgery [published online ahead of print July 31, 2013]. Heart. doi:10.1136/hertjnl-2013-304262. 11. Sittig DF, Singh H. Defining health information technology– related errors. Arch Intern Med. 2011;171(14):1281–1284. 12. Office of the National Coordinator for Health Information Technology. Health Information Technology Patient Safety Action&Surveillance.http://www.healthit.gov/sites/default/ files/safety_plan_master.pdf. Published July 2, 2013. 13. US Department of Health & Human Services. Final HHS Health IT Safety Plan issue. http://www.hhs.gov/news/ press/2013pres/07/20130702a.html. Published July 2, 2013. 14. Modern Healthcare. Joint Commission puts focus on EHR, patient safety. http://www.modernhealthcare.com/ article/20130703/blog/307039936. Published July 3, 2103. 15. Office of the National Coordinator for Health Information Technology. Safer guides. http://www.healthit.gov/policyresearchers-implementers/safer. Published January 15, 2014. 16. Karsh BT, Weinger MB, Abbott PA, Wears RL. Health information technology: fallacies and sober realities. J Am Med Inform Assoc. 2010;17(6):617–623.
Conclusion Takeaways from this column should be clear. Although HIT can move the health care industry forward in terms of safety, quality, and value, it is not without risks.16 The keys are creating a culture of HIT safety while implementing and monitoring an HIT safety plan. Constant vigilance is required. Safety risks of HIT will continue to grow as more health care technologies are used and new technologies emerge.
93 Copyright © 2014 American Association of Critical-Care Nurses. Unauthorized reproduction of this article is prohibited.
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