By 
In 2001, when my colleagues and I ranked nearly 100 patient safety practices on the strength of their supporting evidence (for an AHRQ report), healthcare IT didn’t make the top 25. We took a lot of heat for, as one prominent patient safety advocate chided me, “slowing down the momentum.” Some called us Luddites.
Although we hated to be skunks at the IT party, we felt that the facts spoke for themselves. While decent computerized provider order entry (CPOE) systems did catch significant numbers of prescribing errors, we found no studies documenting improved hard outcomes (death, morbidity). More concerning, virtually all the research touting the benefits of HIT was conducted on a handful of home-grown systems (most notably, by David Bates’s superb group at Brigham and Women’s Hospital), leaving us concerned about the paucity of evidence that a vendor-developed system airlifted into a hospital would make the world a better place.
Since that time, there have been lots of studies regarding the impact of HIT on safety and, while many of them are positive, many others are not. In fact, beginning about 5 years ago a literature documenting new classesof errors caused by clunky IT systems began to emerge. A study from Pittsburgh Children’s Hospital found a significant increase in mortality after implementation of the Cerner system – a study that was criticized by IT advocates on methodologic grounds, and because “they didn’t implement the system properly.” Studies by Ross Koppel of Penn and Joan Ash of Oregon (such as here and here) chronicled the unintended consequences of IT systems, and urged caution before plunging headfirst into the HIT pool. I raised similar concerns in a 2006 JAMA article, and also recounted the iconic story of Cedars-Sinai’s 2003 IT implementation disaster, where a poorly designed interface, combined with physician resistance to overly intrusive decision support, led the plug to be pulled on the $50 million CPOE system only a few weeks after it was turned on.
A new story line was emerging, and its theme was that implementing an effective HIT system is harder than it looks. And yet one could not deny the political attractiveness of computerization – during the last presidential campaign, the need for HIT was the only thing that McCain and Obama seemed to agree on, and a prominent proponent of a Manhattan Project-like push for HIT has been none other than Newt Gingrich, not exactly a freewheeling spender.
These politics led to $19 billion being included in February’s stimulus package to support HIT implementation in American hospitals and clinics. Once federal HIT Czar David Blumenthal figures out how to divvy up the money (it hinges on coming up with a workable definition of “meaningful use” of HIT, which would unlock the door to the federal vault), HIT will have its big Coming Out Party. Cue the balloons and streamers!
It’s all pretty exciting… if the systems work.
Fast forward to today’s Washington Post, where an article describes a new crusade by Iowa Senator Charles Grassley to confront HIT vendors who sell defective products. Grassley, who has taken on the role of keeping professions honest (including scrutinizing physician relationships with pharma and device companies, attention that is long-past due), has raised a number of concerns about the safety of store-bought IT systems, and has sent a letter of inquiry to one of the companies (Cerner) that looks a lot like a prelude to a Senate subpoena.
Interestingly, many of the issues raised in the Grassley letter mirror an argument advanced by Penn sociologist Ross Koppel in JAMA earlier this year (for which he was vilified by the IT community – both implementers and vendors). Ross (who is a friend) noted that most of today’s IT implementation contracts insist on gag clauses for clinicians who identify errors caused by faulty software, and virtually all contain hold-harmless clauses for the vendors in the event that an IT-related error leads to patient harm. The vendors’ case seems like a version of the “guns don’t kill people…” argument: there is nothing wrong with the software, the errors reflect poor implementation practices or screw-ups by users, yada yada. This is certainly true at times, but Ross and others have documented scores of errors that are absolutely inevitable given clunky software and poor user interfaces.
It seems right that the vendors would at least share responsibility if patients were harmed in such circumstances.
This is all acutely interesting to me right now, since my own hospital (UCSF Medical Center) recently entered the not-very-proud fraternity of hospitals who aborted their implementation after an IT system failed to live up to expectations. In our case, nearly a decade ago, we put our IT nickel (actually, more than a billion of them) down on a system built by a vendor named IDX. A few years later, when IDX became wobbly as a company, we were reassured when technology titan General Electric gobbled them up. “They’re GE,” we thought, “they’ll get this right.” We eagerly signed on to be development partners with GE and found ourselves in a world of missed deadlines and inadequate support; in short, neither product nor vendor seemed ready for prime time. After years of negotiations, hair-pulling, and prayer, we recently pulled the plug on our GE relationship. (I’ve been on the committee overseeing our transition, and won’t divulge any confidences, but all of this has now been reported in the media.) Just last week, our CEO Mark Laret publicly announced our intention to pursue an implementation with Epic, the Wisconsin company that appears to be emerging as the best of the breed. I’m hoping that this is the system we’ve been waiting for (the reviews from colleagues who are using Epic elsewhere are generally reassuring), and not, as my friend Jim Reinertsen sometimes quips, simply “The Cream of the Crap.”
Last year, I wrote about the Technology Hype Cycle, a predictable roller coaster in which new technologies are over-hyped (the “Peak of Inflated Expectations”), fail to live up to their expectations (the “Trough of Disillusionment”), and ultimately (if they’re any good) traverse their “Slope of Enlightenment” before reaching a “Plateau of Productivity.” CPOE, and HIT more generally, are clearly on this roller coaster – somewhere between the “Trough…” and the “Slope…” Since we are about to invest 19 billion tax dollars on nationwide implementation of these systems, let’s collectively hope it is the latter.
Obviously, we simply must computerize American healthcare: in 2009, how can we possibly improve our care and coordination when we document our work by writing in chicken scratch on pieces of dead trees? And there are healthcare organizations that have enjoyed successful implementations and are beginning to reap real benefits, in quality, safety, and efficiency.
But it is not a slam-dunk, and there are some crummy systems out there that have the capacity to cause harm. Having folks like Ross Koppel, and maybe even Senator Grassley, push the IT companies to do better and be accountable for their products is critical if we’re going to get this complex but crucial task right.
Robert Wachter is widely regarded as a leading figure in the modern patient safety movement. Together with Dr. Lee Goldman, he coined the term “hospitalist” in an influential 1996 essay in The New England Journal of Medicine. His most recent book, Understanding Patient Safety, (McGraw-Hill, 2008) examines the factors that have contributed to what is often described as “an epidemic” facing American hospitals. His posts appear semi-regularly on THCB and on his own blog “Wachter’s World,” where this post first appeared.
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As an IT professional who has worked on these kinds of systems over multiple decades on a large scale and understands that the greatest challenges are not technical (human errors in using computer systems is one of the largest gotchas), the Health IT czar would do everyone a big favor by dividing the (19-31) billion dollars in half and ensuring that one of those halves be used for funding patient safety and confidentiality projects that will surely be needed for the problems that will come. Without that kind of commitment up front, what will surely happen is that those issues will go on the back-burner as a low priority. As a result, the government will have funded projects with many potentially harmful defects and no way to pay for the remediation. We have far too many decision makers with taxpayer money to spend lacking the longitudinal experience to understand what is ahead. Creating more islands of patient medical information without a carefully planned integration strategy will back everybody into lowest-common-denominator solutions of unsatisfactory quality.
Dear Dr. Coli,
I don’t want to sound discouraging, but I do not see the specific value of the DIS. Similar presentation is possible with most EMR – for instance, once can work very well with Cerner’s so called “flow sheet”, and can also do trend analysis etc.
Mr. Wachter,
One entirely overlooked, but critical functional component of all existing EHR, PHR and HIE platforms that has adversely impacted patient safety, costs and physician and nurse work flow since the mainframe era is reporting patient diagnostic test results as fragmented data using infinitely variable reporting formats.
The simple solution of standardizing the reporting format across the care continuum and displaying organized information by clinically integrating the test results data has been designed and is being developed by a group of Rhode Island physicians.
The Diagnostic Information System (DIS) standard format is described and illustrated at:
http://diagnosticinformationsystem.com .
Bob Coli, MD
Tim,
Your comment is entirely cryptic. You think that physicians have to “heal” themselves by reforming their “physician process”, and that somehow will make health IT work? Are you implying that with physicians practizing more evidence based (and/or more standardized) care, health IT would be a cakewalk? I am really curious about your answer.
The observation that physician-process is highly unstandardized (see Atlas, Dartmouth) is at the genesis of the entire health care reform movement.
Now, decades downstream, and on a website dedicated to that very reform, we have physicians wondering why the programmers can’t build an “interface” to make health IT systems “work”.
Heal thyselves.
I am all for reproting to the FDA all the bugs in my hospital’s system. It is not fit for anything requiring productivity.
No amount of IT will improve care. Why are we so excited abour sharing info, when most patients never get seen elsewhere without a referral and apprpriate transfer including records. it is only when patients start shopping on their own is the trail of information lost, often by patient intent.
THe HIT looks promising in recent years.I believe that we will see some innovative and very useful progress in this field.
Dear Bob,
The answer to the title is a resounding NO.
to Bev: Patients are definitely being killed during deployments of these devices but the deaths are blamed on the users. The users who report deaths as associated with the CPOE instruments are warned and then punished by the hospital administration’s cadre of paid peer reviewers, also known as “champions” or sham peer reviewers.
Will Bob honestly comment about the deaths at UCSF during this procrastinated implementation failure? If you can not comment because of whatever, just say so, but do not parrot industry sound bites that you are “not aware of any patient injury” due to the flawed devices.
The industry and its products would be better and safer today had it not obfuscated the fact that what they are selling as typewriters for orders are experimental medical devices. FDA regulation will facilitate vendor accountability.
At present, each deployment constitutes an experiment without IRB approval. Patients (and their health care providers) are unwittingly being used as subjects in these unregulated proving grounds to help the vendors make better devices. This is ethically wrong and probably illegal.
It is suggested that adverse events and device defects be reported to the FDA. If not there, where?
I left a similar comment on another post, but to repeat, there is precedent for requiring clinical validation and approval of health IT systems – specifically blood bank IT systems, which are regarded as medical devices and subject to FDA approval. (This is also true of PACS systems, I am told). There is thought in some quarters that hospital information systems, or critical parts of them, should be regarded as medical devices and regulated by the FDA. (see link below).
http://medicalconnectivity.com/2007/06/06/fda-to-regulate-some-device-connectivity-to-emrs/
I share the reservations of other commenters concerning virtually ALL off-the-shelf hospital information systems. I have been part of one of these implementation disasters and there are many, many examples other than the Cedars-Sinai one. What gets lost here is that patients are probably being killed during these failed implementations – but the chaos of the failed implementation obscures this scary fact.
Personally, I believe such systems should undergo a great deal more scrutiny by regulators before they are allowed to be marketed, although frankly the FDA probably does not have the resources currently to approve all of them.
Bob:
I wish you all the luck in the world with Epic, which as you know Kaiser spent something like $4billion dollars on and took several years longer than expected before, apparently, getting it right.
I would suggest the problem is not with the idea that EHRs can improve the quality and cost-effectiveness of care, but rather that it has taken a lot longer for us to produce a technology platform that can support these ideals.
I was involved with a similar phenomenon involving phone-based nurse triage software, which was initiatlly perceived to be a brilliant new tool to manage demand for health services. Alas, the original software vendors, much like today’s client-server EHR vendors (including Epic) didn’t have the means to pull it off. It was only when newer players in the field, using newer technology, enabled the dream to be realized. Today, the entire population of the UK has access to NHS Direct, which is a highly popular phone-based nurse triage service that runs on the newer platform.
In the world of EHRs, the same thing is about to happen, as SaaS-based systems slowly replace the client-server model. These systems are far, far less expensive than their ancestors, and the web-based platform facilitates upgrades, which can be turned on, instantly, for all users across the system. In addition, SaaS-based EHRs store patient information off site in HIPAA compliant clouds, a far more safer and more secure place for such data than on-site servers or paper charts. This has a side benefit of allowing de-identified, double-scrubbed patient data to become a resource for clinical investigators and public health officials looking for opportunities to improve the quality of care.
Thanks,
Glenn Laffel, MD, PhD
Sr VP, Clinical Affairs
Practice Fusion
http://www.practicefusion.com
Free, Web-based EHR
Coincidentally, I worked (subsequently and at times parallel) with Cerner, IDX and now Epic, as a physician. I have to say that most programs are not very user friendly – Cerner being a little better than the other two, but slower and more crash prone. I cannot understand why noone seems to be able to do an intuitive interface, with few buttons, left click and right click like in most web browsers (actually, many people compared the VA system favorably to Cerner, which again is the better of the 3 mentioned). There are people studying ergonomics, I am sure there are some doing computer ergonomics – but not in the major EMR companies. Why?