Hospital Mistakes Due to Digital Records Errors are on the Rise
July 8, 2013 12:17 PM
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Advocates say systems prevent more errors than they cause
is highlighting the growing number of medical mistakes due to errors in digital records -- also known as electronic health records (EHRs). These mistakes range from getting unintended surgeries, to overdosing, to missing medications.
I. Digital Record Adoption, Mistakes on the Rise
Advocates argue that the move to digital records will cut costs and -- ironically -- cut mistakes. But in a number of cases the converse appears to be true: medical records are causing medical malpractice incidents in unique ways.
Dec. 2012 study
[abstract] by the
Pennsylvania Patient Safety Authority
shows a strong correlation between hospitals ditching paper records and moving to digital systems. In 2004 there were only 41 reports of errors due to digital records mistakes. By 2011, this was up nearly 2800 percent to 1,142 errors -- and that's just in Pennsylvania.
[Image Source: Pa Patient Saf Advis]
Among the sources of error were:
Drop down menus that led doctors to misselect operation types or medication dosages
Lost information due to text being placed in the wrong input box.
Transmissions errors (pharmacy not having access to hospital records to check for mistakes, etc.)
Software bugs leading to medication information disappearing or being transfered to a different patient
Critics point to incidents like Scot Silverstein's 84-year-old grandmother who died in 2011 after Abington Memorial Hospital somehow lost the information on her chart that indicated she required Sotalol -- a medication for rapid heartbeats. You could say Mr. Silverstein -- Professor Silverstein, more properly -- knows a thing or two about digital records systems and their dangers. He works as a
health-care informatics professor
He grieves, "I had the indignity of watching them put her in a body bag and put her in a hearse in my driveway. If paper records had been in place, unless someone had been using disappearing ink, this would not have happened."
II. Problems are Most Severe in Months Right
Some nurses are complaining as well. Nurses with
Contra Costa County
, near San Francisco, complained that after spending $45M USD on a digital records system from
Epic Systems Corp.
medication records began to disappear leading to serious risks. Rajiv Pramanik, chief medical information officer for the county, acknowledges that there were some errors -- most of which he says came from physicians and other professionals mis-entering information. But he says "the strengths [of the system] are tremendous" and that the county is seeing "dramatic improvement" in cutting entry errors.
The hospital was one of three in the Californian Bay Area to
be fined $50,000
California Department of Public Health
for endangering patients with errors.
[Image Source: ID Experts]
The key trend in the Contra Costa County incidents and other problem hotspots appears to be that the errors are most severe immediately after a new system is installed, likely due to staff being unfamiliar with it. A 2005
[abstract] reports that after the
Children’s Hospital of Pittsburgh
became an early adopter of digital records back in 2002, mortalities rose from 2.8 percent to 6.6 percent in following months.
The University of Pittsburgh Medical Center attacked this study's methodology as "fundamentally flawed" saying it only examined a small number of patients. However, there were reports of patients' medications being delayed to restrictions in the system on when doctors could prescribe drugs to incoming patients and due to the number of clicks required to approve medications in critical life-and-death scenarios.
One expert on these early adoption errors is
, a doctor and chief quality officer at Boston’s
Brigham and Women's Hospital
. He told
, "Any time you computerize a process, it can create new problems, and it typically does."
III. Proponents Fire Back, Defend EHR Bailout Spending
Experts say these tragic incidents and eye-catching lawsuits ignore the bigger picture. They argue the number of mistakes cut by digital records is much greater than those created, thus far.
The push to digitize medical record keeping has had marquee backing; President Barack Hussein Obama
pushed $36B USD of his $787B USD
digitize medical records
; plus he set up a system of fines for those who did not go digital by 2015. He
made EHR adoption
a major pillar of his 2008 election platform.
President Obama has spent big on digitizing health records, and it appears the push is working.
[Image Source: Newscom]
The funding seemed to work -- a
[abstract] in the
New England Journal of Medicine
found only 17 percent of outpatient clinic doctors and only 9 percent of hospital doctors were using digital records. By 2012 a
[abstract] published in the journal
indicated that 69 percent of U.S. doctors had moved to digital record keeping.
And advocates say that despite the reports of errors, the number of mistakes
are far more astounding. A
Feb. 2013 paper
[abstract] in the
Journal of the American Medical Informatics Association
suggests that digital records deployments in the U.S. are cutting 17 million mistakes. Medical systems can help remedy traditional errors, such as doctors prescribing drugs with dangerous interactions or misunderstandings due to doctors' sloppy handwriting.
[abstract] on information submitted to the
U.S. Food and Drug Administration
(FDA) indicates that of 899,768 reports about medical mistakes, only 436 unique events involved digital records, and only four resulted in deaths. However, the present situation is murkier -- after all adoption has grown by nearly an order of magnitude since 2009.
The advocates also point to the financial prosperity EHR generates. The industry has grown to a $24.2B USD a year market in the U.S. Top providers include the aforementioned Epic, McKesson Corp. (
), Cerner Corp. (
), Allscripts Healthcare Solutions Inc. (
), and Siemens AG (
And traditional tech giants are looking to get in on the game as well. General Electric Comp. (
a favorite friend of the Obama administration
jumped into the market in 2009
. Microsoft Corp. (
), Dell, Inc. (
), and International Business Machines Inc. (
) are among the other companies
keen to leverage
this growing space.
The Office of the National Coordinator for Health Information Technology
(Health IT), part of the
U.S. Department of Health and Human Services
(HHS), is the federal agency in charge of confirming the rolled out systems are safe. ONC policy and planning director Jodi Daniel comments, "So far, the evidence we have doesn’t suggest that health information technology is a significant factor in safety events. That said, we’re very interested in understanding where there may be a correlation and how to mitigate risks that do occur."
IV. Got to Keep Them Regulated?
Others take an approach somewhere between the critics and the advocates. Their perspective is that digital records are a good idea, but the implementations have sometimes been poor and medical systems aren't doing a good enough job compensating for the learning curve when it comes to new systems.
Leora Horwitz, a doctor and assistant professor of medicine at Yale University School of Medicine tells
, "I would never go back to paper charts -- clearly electronic records are better. But while they’re good, they’re so far from great it’s astonishing."
Prof. Silverstein agrees, commenting, "My mom would be around right now, bopping around, if they had simply not forgotten to give her $2 of medicine. I want to fix the technology. The technology can help. But it has to be done right."
Some want to take the process of ensuring safety out of the HHS's hands at a federal level. They point out that at this point incident reporting to the FDA or HHS is purely voluntary -- while some, such as Cerner and Siemens do report about incidents with their systems, other companies refused to comment on whether they did, hinting that they may not.
Some want the FDA to manage EHR safety and institute mandatory incident reporting.
[Image Source: Univ. Penn.]
Critics fear that even if companies do self-report, physicians may not. Comments
, adjunct professor of sociology at the
University of Pennsylvania
, "The emphasis on doctors self-reporting errors is ludicrous. When a locomotive crashes into two apartment buildings, we know about it. When a patient gets the wrong med, we seldom know about it."
Some argue that medical devices should be regulated by the FDA, just like all other medications and most kinds of medical equipment. They say the FDA should maintain a federal safety database on EHR, to help improve the systems naturally.
Pa Patient Saf Advis [abstract]
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Health IT risk - recent ECRI Institute "Deep Dive" study
7/10/2013 3:34:42 PM
What is not mentioned is a more recent ECRI study (see
171 health information technology-related problems were voluntarily reported during a nine-week period to the ECRI Institute PSO, a patient safety organization in Plymouth Meeting, Pa., that works with health systems and hospital associations in Kentucky, Michigan, Ohio, Tennessee and elsewhere to analyze and prevent adverse events. Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths.
Extrapolating to mandatory reporting over a year in all healthcare facilities, not just 36 hospitals raises great concern, especially since there is no definitive data on paper-related harms nor on EHR-related benefits (the studies that report benefits on safety and cost-savings are anecdotal, if not outright defective, e.g., ONC's so-called literature survey; see
There are actually severe impediments to knowing the risks of clinical IT. Institute of Medicine had this to say in their 2012 report on health IT safety:
"... Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety... The magnitude of the risk associated with health IT is not known."
The FDA itself authored an internal memo in 2010 on health IT risks, not for public viewing but somehow obtained by investigative reporter Fred Schulte, that also notes EHR-related adverse events and impediments to knowing the true magnitude; see the memo itself at
In effect, national implementation of electronic records is a massive experiment - and you don't get the opportunity to provide your informed consent. Your "betters" have decided the issue for you.
More on these issues in a "primer" at link at top of
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