Though we’ve been writing about unintended consequences of healthcare IT since 2007 (see the list of prior columns at the end of today’s column), such have really attracted widespread attention in the last couple years. In our January 2013 What's New in the Patient Safety World column “More IT Unintended Consequences” we noted important contributions from the Institute of Medicine (IOM 2011) and the Pennsylvania Patient Safety Authority (Spannon 2012) addressing patient safety issues arising from EHR’s. And in 2012 the ONC (Office of the National Coordinator for Health IT) released its proposed its Health IT Patient Safety Action and Surveillance Plan (ONC 2012), designed to help provide necessary data through reporting adverse event for developers, providers, researchers and policymakers to improve the safety of health IT and make care safer.
In 2014 the Office of the National Coordinator for Health Information Technology issued the “SAFER” guides that identify recommended practices to optimize the safety and safe use of EHRs (ONC 2014). Then in 2015 The Joint Commission issued Sentinel Event Alert #54 on “Safe use of health information technology” (TJC 2015). Both drew attention to the many ways in which healthcare IT-related issues have been associated with adverse patient outcomes.
An excellent contribution on patient safety problems related to healthcare information technology (IT) was recently published (Graber 2015). Graber and colleagues culled 248 cases of malpractice claims related to healthcare IT from the large CRICO database over the period 2012-2014. Because this is a malpractice database the results are obviously biased towards cases with more serious adverse outcomes. So we cannot quantify the incidence of harm related to healthcare IT issues nor the overall likelihood of harm as a result of healthcare IT issues. Nevertheless, this study demonstrates that there are indeed cases of harm related to healthcare IT issues and has many valuable lessons.
To the 248 cases they applied their proprietary taxonomy of 15 sociotechnical category codes to determine which IT issue categories were most likely to be associated with malpractice claims. Not surprisingly, they found that cases spanned the categories and no one category stuck out as being most vulnerable. Rather the clinical context in which they occurred seemed to be more important.
Of the cases, 146 occurred in the ambulatory setting and the rest in inpatient or ER settings. Lumping them into 2 major categories of contributing factors, they found user-related issues accounted for 63% and system-related IT issues in 58% (many cases had contributing factors from both major categories). Medication-related issues (31%), diagnostic errors (28%), and errors related to treatment (31%) accounted for 90% of the claims. Over 80% of claims in all settings had harm of medium or high severity. Fatal outcomes occurred in 18% of the ambulatory claims and 39% in the ER or inpatient settings.
In the ambulatory setting one contributing factor category did stand out: issues related to hybrid record systems. That should not come as a surprise. In our July 2009 What's New in the Patient Safety World column “Failure to Inform Patients of Clinically Significant Outpatient Test Results” we noted a study (Casalino 2009) which showed those practices using a combination of paper and electronic records (so called “partial EMR”) had higher rates of failure to inform patients of abnormal test results than those having either a full EMR or full paper-based systems. Perhaps in the current Graber study this reflects the time when offices were just making the transition from paper-based systems to electronic medical records. But, as pointed out by the authors, it also likely means that future periods of transition (eg. system upgrades, changes to new IT systems, etc.) are also likely to be vulnerable periods.
The real value of the Graber study, however, comes from the case examples provided and the several recurrent themes they observed. We already alluded to the theme of hybrid medical records being especially vulnerable. A second theme relates to delays in diagnosis or treatment due to results or reports or actions that are missing, delayed, misdirected, or incorrect. While we all know how easily reports could get filed in the wrong patient chart in the paper-based world, misdirection of reports and other information also occurs in the EHR world. Graber and colleagues note that we need to better understand both the system- and user-related causes of misrouting errors. Several of our prior columns have addressed the issue of test results “slipping through the cracks”, resulting in delays or failure to diagnose and treat serious conditions. Most recently, in our November 17, 2015 Patient Safety Tip of the Week “” we noted that any acceptable system for tracking followup on patient tests needs to do the following:
You’d think that today’s sophisticated EMR’s would have built in even better systems for tracking test results. But one big problem is still lack of interoperability among various systems. Many reports still arrive back at the office in paper format rather than an electronic format. Of course, we can scan those paper reports into most EMR’s. Don’t forget: paper-based reports always were vulnerable to the issue of two pages sticking together, often resulting in a report being filed in the chart of the wrong patient. And we’ve also pointed out the critical issue of test results coming back after a hospitalization or ER visit that never get back to the primary physician because of lack of interoperability (and lack of systems that ensure the hospital-based physicians follow up with the primary physician).
Another theme in the Graber study was that, largely because of cut-and-paste capabilities or ability to pre-populate data, incorrect information may be propagated in the medical record. For example, importing a previous medication list might include medications the patient is no longer taking. Or omission of a medication on a medication list may result in continued omission of that medication in the future. They also emphasized the well-known risks of overriding alerts and employing workarounds.
One overarching theme was overreliance on the EHR. We often assume that the information contained in it is both complete and accurate.
And lack of some functionality that should be expected of a computerized system is also a theme. Examples given are failure to identify decimal point errors that result in overdoses of medications, or failure to identify an inappropriate order for potassium in a patient already hyperkalemic.
The Graber study includes some design issues as well. As an example they note a complaint field in the EHR was too small to include the full complaint causing entry of “epigastric pain” rather than “sudden onset of chest pains with burning epigastric pain, some relief with antacid” in a patient who subsequently experienced a cardiac event.
Many of the issues addressed in the Graber study are reflected in a new guideline issued by the National Institute of Standards and Technology (NIST) for EHR standardization (Lowry 2015). That guideline identifies 3 critical use risk areas:
They note that lack of standardization may result in ordering or recording information in the wrong patient chart. Our Patient Safety Tips of the Week for May 20, 2008 “CPOE Unintended Consequences – Are Wrong Patient Errors More Common?” and July 17, 2012 “More on Wrong-Patient CPOE” discussed many of the reasons such errors occur and noted some of the tools that have been used to minimize the chances of such occurring. However, standardization would be very important in helping prevent such errors. NIST also notes that information is often fragmented and stored in different locations in the EHR, leading to difficulty finding it. In addition, some information is verbal or on paper or white boards and does not get input into the EHR. Moreover, context is typically lacking. Navigation issues, scrolling issues, etc. also interfere with finding of information. Other issues include how to identify draft vs. final versions and how changes are made and identified as such. Unnecessary duplication of data input (eg. height and weight) was noted as an issue (though note our caveats in our December 8, 2015 Patient Safety Tip of the Week “”).
Two “use cases”, one for the inpatient setting and one for the outpatient setting, are provided in the NIST guideline for validation and usability testing.
The SAFER Guides (ONC 2014) also provide excellent recommendations regarding issues such as ensuring correct patient identification, test tracking and followup, CPOE and clinical decision support, communication, and several system and organizational issues. These come with checklist-style self-assessment tools and recommendations on how your organization can go about assessing and addressing these vulnerabilities. These are excellent tools.
The EHR and other computerized tools are clearly here to stay and offer tremendous potential to improve patient safety. We have yet to realize their full potential. Taking steps to correct the many unintended consequences we have seen will help us realize that potential. These resources and many we’ve described in our previous columns are a step in the right direction.
See some of our other Patient Safety Tip of the Week columns dealing with unintended consequences of technology and other healthcare IT issues:
Institute of Medicine (IOM). Health IT and Patient Safety: Building Safer Systems for Better Care. November 8, 2011
Spannon E, Marella WM. The Role of Electronic Health Record in Patient Safety Events. Pa Patient Saf Advis 2012; 9(4): 113-121
ONC (Office of the National Coordinator for Health Information Technology). Health IT Patient Safety Action and Surveillance Plan. December 21, 2012
ONC (Office of the National Coordinator for Health Information Technology). SAFER GUIDES—Safety Assurance Factors for EHR Resilience. 2014
The Joint Commission. Sentinel Event Alert #54. Safe use of health information technology. March 31, 2015
Graber ML, Siegal D, Riah H, et al. Electronic Health Record-Related Events in Medical Malpractice Claims. Journal of Patient Safety 2015; Published Ahead-of-Print November 6, 2015
Casalino LP, Dunham D, Chin MH et al. Frequency of Failure to Inform Patients of Clinically Significant Outpatient Test Results. Arch Intern Med. 2009; 169(12):1123-1129
Lowry SZ, Ramaiah M, Taylor S, et al. NISTIR 7804-1. Technical Evaluation, Testing, and Validation of the Usability of Electronic Health Records: Empirically Based Use Cases for Validating Safety-Enhanced Usability and Guidelines for Standardization. National Institute of Standards and Technology 2015
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