Showing posts with label Healthcare IT experiment. Show all posts
Showing posts with label Healthcare IT experiment. Show all posts

Wednesday, January 23, 2019

Experts declare physician burnout ‘a public health crisis’ - and health IT a significant pathogen

I'm certain when the information technology hyperenthusiasts and non-clinical management information systems "experts" and pundits get the technology all figured out, this burnout crisis will end.


It will be about the same time as Zefram Cochrane invents the warp drive in Bozeman, Montana just prior to first contact by the Vulcans. That is in 2063 or so.


Experts declare physician burnout ‘a public health crisis’
January 22, 2019
https://www.healio.com/psychiatry/practice-management/news/online/%7B7f2124e2-d72e-4e3e-be53-6fbe41986186%7D/experts-declare-physician-burnout-a-public-health-crisis

Experts from leading U.S. health organizations deemed physician burnout “a public health crisis” in a recent report.

Physician burnout has received some attention in recent years, but not enough. As a result, it is both poorly understood and getting worse,” Andrew R. Iliff, MA, JD, lead writer and program manager at Harvard Global Health Institute, told Healio Psychiatry.

“Like the blind man describing an elephant, people have described the challenges in front of them, including unhelpful electronic health records and a looming physician shortage,” he continued. “We believe it is important to frame this as a systems problem, requiring systemic solutions in order to avoid further adding to ballooning health care costs and undermining the provision of care.”

In their paper, experts from Harvard T.H. Chan School of Public Health, the Harvard Global Health Institute, the Massachusetts Medical Society and the Massachusetts Health and Hospital Association recommended ways to address the prevalence of burnout among physicians and other health care providers. Recommendations included:
  • appointing an executive-level chief wellness officer (CWO) at every major health care organization;
  • providing support for those experiencing burnout; and
  • improving the efficiency of EHRs.

More on that third Pavlovian, formulaic, hackneyed, health IT amateur-proffered bullet point in a moment.

... The usability of EHRs must be addressed through reform of certification standards by the federal government; improved interoperability; use of application programming interfaces by vendors; and increased physician engagement in the records’ design, implementation and customization, according to the report.

"Certification" standards are useless towards the stated ends.  Interoperability via API's is not the major issue, either; fundamental operability and, ultimately, clinician burden is.

It is also far too late in the game for "physician engagement" to make any difference.   People in my specialty, myself included dating back to the 1990's - and me on this blog starting ca. 2004 - had been calling for clinician (and especially Medical Informatics) leadership (not merely "engagement") of health IT. 

I note that the original title for my health IT academic site, still residing here, was "Preventing Medical Errors: Medical Informatics and Leadership of Clinical Computing."  The original ca. 1999 site is partially archived at http://www.ischool.drexel.edu/faculty/ssilverstein/informaticsmd/index_org.htm.

Little has changed, and the worst predictions I'd been making about the healthcare IT bubble/experiment (see query search https://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment) seem to be reaching unfortunate fruition.

Regarding the "efficiency" bullet point above:  quite seriously, from the perspective of this trained-by-the-pioneers Medical Informatics specialist, the "efficiency of EHRs" can only marginally be "improved."  This is due to both technical and political reasons.  The systems are far too complex, with far too many templates, widgets, options, "tricks", "gotchas" etc.  (with user manuals hundreds of pages long for each, that cause even my eyes to glaze over), too embedded, too protected by the industry, especially those involving legacy code, and too entrenched by politics - to name just some of the issues making major reform of the systems themselves impractical.

The situation should never have gotten this far, predicted as far back as 1969 by EHR pioneer Dr. Donald A.B. Lindberg (http://www.nlm.nih.gov/od/roster/lindberg.html), who wrote that an effect of the "over sell" even occurring then has been "the feeling that logic compels us to build total hospital information systems like military command-and-control systems ... and other grotesque concepts too numerous to mention."
  

Lindberg in 1969.  From Collen, "A History of Medical Informatics in the United States: 1950 to 1990"

What is needed is a significant downgrading of required clinician (physician/nurse) interaction with these "command-and-control systems", including data entry, and the use of clericals to perform those functions.  See my August 2016 essay "More on uncoupling clinicians from EHR clerical oppression" at https://hcrenewal.blogspot.com/2016/08/more-on-uncoupling-clinicians-from-ehr_91.html

More generally, see my numerous posts on this issue at https://hcrenewal.blogspot.com/search?q=oppression

One last quote from the Healio article:
... Burnout not only causes physicians suffering, it also can adversely impact patients. Prior research has shown that burnout may does increase the risk for medical errors.  [Fixed the academic equivocation - ed.]

Put more simply, physician and nurse burnout can kill you.

If a healthcare organization cannot afford the appropriate clerical help to avoid clinician burnout, then they cannot afford an EHR.

Finally:

Can I now say "I told you so?" without the health IT industry sockpuppets coming out of the woodwork? (http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html)

-- SS

Monday, April 10, 2017

Pittsburgh Post-Gazette: "Medication errors in hospitals don’t disappear with new technology". Government: "It's the doctors' fault." I am cited.

The Pittsburgh Post-Gazette published an article on EHR problems yesterday entitled "Medication errors in hospitals don’t disappear with new technology."  It is based on a recent study by the Pennsylvania Patient Safety Authority, retrievable here:  http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2017/Mar;14(1)/Pages/01.aspx

I am cited.  Also cited is an HHS official, Dr. Andrew Gettinger, acting deputy national coordinator for health information technology in the U.S. Dept. of Health and Human Services, who disagreed with my views.  I am familiar with Dr. Gettinger's views.  More on that later.

Medication errors in hospitals don’t disappear with new technology
Steve Twedt
Pittsburgh Post-Gazette
http://www.post-gazette.com/business/healthcare-business/2017/04/10/medication-error-electronic-health-record-hospitals-patient-safety-authority/stories/201704090072

In the first six months of 2016, Pennsylvania hospitals reported 889 medication errors or close calls that were attributed, at least in part, to electronic health records and other technology used to monitor and record patients’ treatment.

A majority of the errors pertained to dosages — either missed dosages or an administration of the wrong dose. Of the 889 errors, nearly 70 percent reached the patient. Among those, eight patients were actually harmed, including three involving critical drugs such as insulin, anticoagulants and opioids.

The extent of the injuries was not detailed, although no deaths were recorded.  Those are the stark numbers in a new analysis by the Pennsylvania Patient Safety Authority, an independent state agency that looks at ways to reduce medical errors.

But interpretations of the report’s significance — and specifically the overall benefits and risks of information technology in a hospital setting — cross a wide spectrum.

The wide spectrum is the gap between those who believe in what might be called cybernetic supremacy (that is, the hyper-enthusiasts who ignore the real-world downsides of technology such as today's EMRs) versus those who promote what I call cybernetic sobriety (a more candid, mature attitude fostered by actual knowledge of the long history of cybernetic failures and the myriad causes of such failures).

Some view reports such as that of the Pennsylvania Patient Safety Authority (PPSA) in a reasonably patient rights-oriented manner, including the PPSA itself:

“This is the classic ‘tip of the iceberg,’” said pharmacist Matthew Grissinger, manager of medication safety analysis for the Patient Safety Authority in Harrisburg and co-author of the analysis with fellow pharmacist Staley Lawes. “We know for a ton of reasons not every error is reported.”

I've written extensively at HC Renewal on the "tip of the iceberg" issue, a phrase also used in the past by the FDA CDER (Center for Devices & Radiological Health) director Jeffrey Shuren MD JD and others.  See for example my February 28, 2010 post "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths In Two Years, Probably Just 'Tip of Iceberg'" at  http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html as well as my January 8, 2016 post "Yet another observation that known health IT-caused injuries and deaths are 'the tip of the iceberg'" at http://hcrenewal.blogspot.com/2016/01/yet-another-observation-that-known.html.

Of course, a PPSA disclaimer was issued, in my view perhaps to placate the health IT industry:

...Mr. Grissinger cautioned that the findings are “absolutely not” an indicator that patients are less safe, as hospitals have moved from paper to electronic records incorporating health information technology...the authors did conclude that technology meant to improve patient safety “has led to new, often unforeseen types of errors” due to system problems or user mistakes.

A more correct statement might have been that "these most current findings are yet another red flag that patients could be less safe with bad health IT, but since there are a 'ton of reasons' not every error is reported, we just don't know - and we truly need to devote a great deal of effort towards filling the gaps in our limited knowledge."

I've written on the issue of not jumping to health IT safety conclusions, one way or another, based on current data, especially when that data is admittedly limited.  For example, see my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.

In that post I noted that a secret 2010 FDA internal report on health IT risk (marked "not for public use") unearthed by investigative reporter Fred Schulte stated that "...In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology...The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and impedes a more comprehensive understanding of the actual problems and implications."

We don't know what we don't know, but to date the efforts to robustly learn the truth has been milquetoast to non-existent.  "Proof (of safety) by lack of evidence" - in an area where we admit the evidence is likely severely deficient - seems to be the default industry go-to position.  "Proof by lack of evidence", of course, is a logical fallacy.

Back to the Pittsburgh Post-Gazette:


... Frustration with the technology
In January 2015, 35 physician groups — including the American Medical Association, the American Academy of Family Physicians and the American Society of Anesthesiologists — sent a nine-page letter about electronic health records to the national coordinator for health information at the U.S. Department of Health and Human Services.

Their purpose was to convey their “growing frustration with the way EHRs are performing,” the letter stated.

“Many physicians find these systems cumbersome, do not meet their workflow needs, decrease efficiency, and have limited, if any, interoperability. Most importantly, certified EHR technology can present safety concerns for patients.”

That Jan. 2015 letter is at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf and speaks for itself.  Kudos to the Post-Gazette for citing it; the public is largely unaware of its existence.

I am then cited in the Gazette article:

Physician Scot Silverstein, a Philadelphia-based consultant and independent expert in electronic health records and vocal critic of such systems, calls the software “legible gibberish” better designed for handling warehouse inventory than managing and monitoring patient care in a clinical setting.

“Electronic health records are a massively complex computer application, far too complex than is needed for a clinic taking care of patients,” he said in a phone interview. “EHRs need to be toned down, be less complex, and be used less.”

Opportunities for mistakes are numerous, he said, as a physician may have to scroll through multiple screens, while each screen with a dozen or more columns plus an array of drop down menus. Some systems, he said, allow doctors to keep screens on multiple patients open simultaneously, increasing the chances of a medication mix-up.

“The software needs to be designed better.”

I am a vocal critic of bad health IT, and actually called the output of the systems to be "legible gibberish" as at my Feb. 27, 2011 post "Two weeks, two reams" at http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html, but the quote is close enough.

Indeed, today's EHRs seem more designed for mercantile, manufacturing and management settings, and "calm, solitary office environments" (channeling Joan Ash) rather than the incredibly complex, poorly bounded and unpredictable environment of clinical medicine.

I am quoted accurately on the complexity and overuse issue, although the issue of preventing  physicians from having multiple patient screens open was actually a short term workaround known to me to have been put in effect some years back.  This was done when a major EHR was unpredictably transposing orders into wrong charts when multiple patient's screens were open (creating two potential patients at risk).

The software indeed needs to be designed better, to meet clinical needs.


Dr. Silverstein, who says his mother’s death was precipitated by a heart medication mix-up involving her electronic health record, cites federal initiatives giving hospitals financial incentive to implement electronic health systems as pushing the programs without sufficient vetting.

“The thinking was, ‘Computers plus doctors equals better medicine,’ period. But the technology was not and is still not ready for that kind of push.”

Indeed it was not ready, being experimental technology. Further, vetting in real-world settings via robust premarket surveillance, and postmarket surveillance of any rigor were, in fact, absent when massive incentives (and penalties) were announced as part of the so-called Economic Recovery Act and its "HITECH" component.

Instead, he recommends some combination of paper, with paper imaging capability so records are accessible, and electronic systems. “I don’t think paper should or ever will go away completely,” he said.

On this issue, and for a highly successful real-world example, see my August 6, 2016 post "More on uncoupling clinicians from EHR clerical oppression" at http://hcrenewal.blogspot.com/2016/08/more-on-uncoupling-clinicians-from-ehr_91.html.

I note with some irony about the above linked post (regarding a highly successful EMR that protected clinicians from oppressive clerical burdens) that the newly-appointed Director of the Office of the National Coordinator for Health IT (ONC), Dr. Donald Rucker (http://www.healthcareitnews.com/news/donald-rucker-named-new-national-coordinator-onc), was formerly the Chief Medical Officer of Shared Medical Systems, a hospital infrastructure IT provider.  He then became CMO of the failed Siemens Healthcare EMR effort after SMS was bought out ca. 2000.  Siemens Healthcare officials told me ca. 2007 that the real-world, highly successful invasive cardiology information system I'd developed as shown in the aformentioned Aug. 2016 post was "impractical" for commercial emulation.

Back to the Post-Gazette article.  In it, a government health IT official blames the doctors, a line I've heard dating back to the early 1990s when I was a postdoctoral informatics fellow at Yale:

A need for better training

Anesthesiologist Andrew Gettinger, acting deputy national coordinator for health information technology in the U.S. Dept. of Health and Human Services, disagrees with Dr. Silverstein.

He identified three key components to a successful electronic health record system — good design and implementation and the users’ good understanding of the system.

I have no disagreement there, only on the route to achieve those goals.

“What we find is that many clinicians who complain vociferously about the software and how many clicks it takes, and how user unfriendly it is, have not actually taken the time to understand the system,” he said.

This seems the "blame the physicians, they're just complainers and Luddites" canard I've written about for almost 20 years now.

Gettinger seems to ignore the issue of bad health IT and use error:

  • Bad Health IT is health IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, lacking in evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.   (S. Silverstein and J. Patrick).
  • Use error (as opposed to user error) is defined by another U.S. government agency, the National Institute of Standards and Technology (NIST) as follows: "Use error" is a term used very specifically by NIST to refer to user interface designs that will engender users to make errors of commission or omission. It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc. From "NISTIR 7804: Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records." It is available at
http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf (PDF).

No amount of "training" can compensate for those issues.  Further, physicians and nurses just don't have abundant time for such training about mega-complex systems, on which they're already spending 50% or more of their time.  They especially don't have the time to learn multiple EHR's, a situation that exists for clinicians who work on more than one hospital.  I possess the physician and nurse user guides for a number of EHRs though my forensics work.  A manual for an EHR is as complex as a manual for an office suite like MS Office, or an OS such as Windows.

There's also the fact that physicians and nurses are not reimbursed for the hours they spend feeding the payers and other profit-makers the data, for free.

“Quite frankly, doctors are not always the best at signing up for training and taking the training...

Blaming the doctors again.

... , and some of the training is not always the best.”

Not that, as mentioned previously, "training" is at the root of the EHR problem.


He allowed that the usability criticism “is a very legitimate thing to look at”... 

How kind of Dr. Gettinger to acknowledge what has been known in the IT world for decades about poor usability, e.g., this mid 1980's wisdom written for the U.S. Air Force on user interfaces:



GUIDELINES FOR DESIGNING USER INTERFACE SOFTWARE
ESD-TR-86-278
August 1986
Sidney L. Smith and Jane N. Mosier
The MITRE Corporation
Bedford, Massachusetts, USA
Prepared for Deputy Commander for Development Plans and Support Systems, Electronic Systems Division, AFSC,
United States Air Force, Hanscom Air Force Base, Massachusetts.
Approved for public release; distribution unlimited.
SIGNIFICANCE OF THE USER INTERFACE

The design of user interface software is not only expensive and time-consuming, but it is also critical for effective system performance. To be sure, users can sometimes compensate for poor design with extra effort. Probably no single user interface design flaw, in itself, will cause system failure. But there is a limit to how well users can adapt to a poorly designed interface. As one deficiency is added to another, the cumulative negative effects may eventually result in system failure, poor performance, and/or user complaints.

Outright system failure can be seen in systems that are underused, where use is optional, or are abandoned entirely. There may be retention of (or reversion to) manual data handling procedures, with little use of automated capabilities. When a system fails in this way, the result is disrupted operation, wasted time, effort and money, and failure to achieve the potential benefits of automated information handling.

In a constrained environment, such as that of many military and commercial information systems, users may have little choice but to make do with whatever interface design is provided. There the symptoms of poor user interface design may appear in degraded performance. Frequent and/or serious errors in data handling may result from confusing user interface design [in medicine, this often translates to reduced safety and reduced care quality - ed.] Tedious user procedures may slow data processing, resulting in longer queues at the checkout counter, the teller's window, the visa office, the truck dock, [the hospital floor or doctor's office - ed.] or any other workplace where the potential benefits of computer support are outweighed by an unintended increase in human effort.

In situations where degradation in system performance is not so easily measured, symptoms of poor user interface design may appear as user complaints. The system may be described as hard to learn, or clumsy, tiring and slow to use [often heard in medicine, but too often blamed on "physician resistance" - ed.] The users' view of a system is conditioned chiefly by experience with its interface. If the user interface is unsatisfactory, the users' view of the system will be negative regardless of any niceties of internal computer processing.

Back to Dr. Gettinger for a somewhat non-sequitur 'BUT' disclaimer:

... BUT he defended the federal incentives, saying they defrayed the cost to hospitals while encouraging vendors to develop better systems.

I would say the incentives, just like the spectacularly failed subprime mortgage market a decade ago, just incented the health industry to waste hundreds of billions of dollars on half-baked, experimental technology, alienating physicians and nurses (cf.: the 2015 Medical Societies letter mentioned above).  The incented effort even put some organizations in financial jeopardy, e.g.,

 "MD Anderson to cut about 1,000 jobs due to 'financial downfall officials largely attributed to its EPIC EHR implementation project'
" at
http://hcrenewal.blogspot.com/2017/01/heath-it-mismanagement-md-anderson-to.html

"What is more important in healthcare, computers, or nurses and other human beings? Southcoast Health cutting dozens of jobs on heels of expensive IT upgrade" at http://hcrenewal.blogspot.com/2016/04/what-is-more-important-in-healthcare.html

"Lahey Health: hospital jobs lost, but computer vendors prosper" at http://hcrenewal.blogspot.com/2015/05/lahey-health-hospital-jobs-lost-but.html,

"Monetary losses and layoffs from EHR expenses and EHR mismanagement" (http://hcrenewal.blogspot.com/2013/06/monetary-losses-and-layoffs-from-ehr.html),

"Financial woes at Maine Medical Center: Reading this blog might have saved them millions of dollars, and prevented massive 'cost saving initiatives'" (http://hcrenewal.blogspot.com/2013/05/financial-woes-at-maine-medical-center.html),

and "In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red" (http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html)

I also believe the easy money disincented the vendors from improving the techology, instead selling what they had on hand and acting to discourage innovation and competition to maximize their profits, e.g., see my April 16, 2010 post "Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'" at
http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html and my August 31, 2012 post "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" at http://hcrenewal.blogspot.com/2012/08/health-it-vendor-epic-uses-clients-as.html.

Finally, I regrettably note that Gettinger seems to possess a rather hard-nosed attitude about health IT harms.  I have contributed, of course, to articles about EHR's in other publications, including, among many others, Politico.  Arthur Allen at Politico wrote me this in 2015 regarding my opposition to the toothless "Health IT safety center" concept, and my promotion of a need for true HIT regulation:


On Wed, Jun 17, 2015 at 1:13 PM, Arthur Allen <aallen@politico.com> wrote:
I’m putting together a piece on the safety center with some notes from an interview I did with Andy Gettinger a few weeks ago. I asked him whether he though the RTI panel (which RTI named, apparently) would have come to the same consensus – that the safety center should be a safe harbor, not an investigatory agency – if you [i.e., me - Scot  - ed.] had been on the panel.

He said,
“he [i.e., me - Scot - ed.] may have heard what we were intending and been able to step back from specific things relative to his mother’s care and gotten to a space to see that this initiative has the potential of making real change in the EHRs used throughout the country. I would have loved to have Scot at the table.”

Any response?


In other words, if only I was able to "step back" from my mother's severe injury, year's worth of horrible suffering as a cripple before she died as a mentally-impaired vegetable, and my lovely mother being taken away from my home in a body bag as a result of a health IT mishap, I'd be able to see just how wonderful a toothless HIT safety center would be.  (Also, I was never asked to be "at the table".)

What a kind comment that was. 

In conclusion:

While I wish the Pittsburgh Post-Gazette article was longer, in its limited space its author did touch upon the major relevant issues well regarding the PA Patient Safety Authority study and its implications towards national Health IT policy.

ONC's Dr. Andrew Gettinger's responses, however, seems to reflect an unwillingness of he and the government to acknowledge Bad Health IT.  His repsonses also appear to show a lack of appreciation of the complaints about EMRs from nearly 40 medical societies.  "It's the doctors fault" for not training enough.

He does acknowledge that better IT would be a good thing, but to date the best HHS could come up with to achieve that goal is a toothless Safety Center. Healthcare IT would be the only healthcare device sector afforded that extraordinary regulatory accommodation.

The notion that all that is needed to solve EMR problems is clerical training of (resistant) physicians seems that of a computing dilettante, and/or a health IT hyperenthusiast.  Such a view ignores decades of knowledge of bad IT, and in multiple sectors.

The blaming of physicians is also decidedly unhelpful towards the reputation of the technology and its enthusiasts in government.  Bad enough that physicians are already spending 50% or more of their time at computers, distracting from patient care.  Gettinger's "solution" also fails to acknowledge that physicians often work in multiple hospitals with different EHRs. They don't have the time to become clerical experts in multiple mega-complex systems.

Claiming the national incentives promoted the vendors to make better health it is also absurd. It actually promoted them to sell the bad health IT they had on hand, and lessened any motivation to improve the technology.

What the issues really boil down to is a conflict between those who believe in cybernetic supremacy (the hyperenthusiasts who ignore the real-world downsides) versus those who promote what I call cybernetic sobriety (a more candid, mature attitude fostered by actual knowledge of the long history of cybernetic failures and the myriad causes of such failures).

-- SS

Friday, March 24, 2017

An eloquently expressed lesson from Nanaimo (Canada) on electronic medical records failure

Unfortunately, this eloquent piece on EHR failure expresses precisely the major problems with this experimental technology that generic medical managers and other medical bureaucrats are unwilling to hear, and/or unable to fully comprehend.

At my May 31, 2016 post "HIT Mayhem, Canadian Style: Nanaimo (Vancouver Island) doctors say electronic health record system unsafe, should be shut down, non-medical PR hacks say it's perfectly safe" at http://hcrenewal.blogspot.com/2016/05/hit-mayhem-canadian-style-nanaimo.html, I wrote:

... To hell with doctors and nurses and their concerns about horrible health IT.   

That seems the international standard in 2016 regarding their concerns.  There's just too much money to be made in this business to worry about such piddling annoyances as maimed and dead patients.

Doctors, after all, don't know anything about computers, and cybernetic medical experiments on unconsenting human subjects are
 just good fun.

This new example from Canada:


http://www.theprovince.com/health/local-health/nanaimo+doctors+electronic+health+record+system/11947563/story.html 

Nanaimo doctors say electronic health record system unsafe, should be shut down

By Cindy E. Harnett
Victoria Times Colonist
 
May 27, 2016

Implementation of a $174-million Vancouver Island-wide electronic health record system in Nanaimo Regional General Hospital — set to expand to Victoria by late 2017 — is a huge failure, say senior physicians.

Who cares what they say?  They're just doctors, so sayeth the imperial hospital executives.. 
 


Here is an update:

http://www.canadianhealthcarenetwork.ca/physicians/discussions/opinion/a-lesson-from-nanaimo-on-the-human-costs-of-electronic-health-records


A lesson from Nanaimo on the human costs of electronic health records

WRITTEN BY DR. DAVID FORREST ON MARCH 22, 2017 FOR CANADIANHEALTHCARENETWORK.CA

Dr. David Forrest (Dr. Forrest is a Nanaimo internist and the president of the Nanaimo Medical Staff Association.)

For the last 12 months, staff at Nanaimo Regional General Hospital in B.C. have been using a Cerner-based electronic health record (EHR). This includes computer physician order entry, linked to computerized order management, and fully electronic documentation.

Since shortly after the system was activated, physicians have consistently and increasingly expressed concerns about the safety of the system (with, for example, orders being mistranslated by the system or disappearing) and its inefficiency, which reduces patient access to care. As a consequence, with the support of the B.C. Ministry of Health, the Island Health Board has directed the Health Authority to suspend CPOE and related processes—though Island Health is delaying this.

While the primary issues with iHealth have focused on safety concerns, little attention has been paid to the human costs of the EHR and its implementation.

"Little attention has been paid to the human costs" due to the fact that most of that attention has gone to the entity that seems to have usurped the rights of patients and clinicians, namely, computers.   "Cybnernetics over all" seems the continuing saga of healthcare, as I'd written in the past.

I am increasingly appalled when I read common accounts like this, now ongoing since my entry into medical informatics 25 years ago.  The term "learning organization" that I've been hearing since the 1990's extolled as what healthcare managers claim they aspire to seems a sad joke.


Currently designed EHRs significantly alter processes of care. Computerised order entry is a laborious process, requiring multiple steps to perform simple tasks. As demonstrated in other settings (such as the airline industry), such complex processes are inherently error-prone. Moreover, the inputting of more intricate orders is even more difficult, resulting in “work-arounds” or inaccurate enactment of physician management plans, with additional safety risks.


I've written in past posts that the "atomization" of order entry and other functions into multiple subcomponents with different user interface widgets, rules and "gotcha's" is a monstrous tool created by those without a knowledge of what it's like in chaotic patient care environments.  Those designers also seem, for example, to lack the ability to design tools that parse freetext orders into those atomic parts with little user intervention.  The syntax of the bulk of medical ordering is not all that complicated, for example.

“User error” has become a buzz phrase for system-based processes that result in inability to enact orders as intended by physicians—and physician users are the ones responsible, thus morally if not legally liable not just for order entry but for their management downstream. It is little wonder physicians in Nanaimo since the introduction of the EHR feel uncertain, anxious, frustrated and exhausted.

Two points, the first of which I expressed to the author via email. 

First, "user error" is a buzz phrase for those ignorant of human-computer interaction best practices to lay blame for faulty designs on victimized (and usually compelled) users.

The more correct term in many cases is "use error" - not "user error."  Use error, as defined by the US National Institute of Standards and Technology (NIST) in their study of health IT, is as follows (see also my Oct. 2011 post at http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html):

“Use error” is a term used very specifically to refer to user interface designs that will engender users to make errors of commission or omission. It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging [or lack of messaging, e.g., no warnings of potentially dangerous actions - ed.], misuse of color-coding conventions, omission of information, etc.


The second point I will make regarding clinicians feeling "uncertain, anxious, frustrated and exhausted" is that this health IT fits the definition of bad health IT in terms of its creating stressors:


Bad health IT is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, lacks evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 


That definition was the result of joint thinking by myself and a colleague, Australian informaticist Jon Patrick, PhD.

This experience is not singular, as a number of studies in the U.S. suggest that EHRs are now the primary cause of physician burnout. This further jeopardises patient care since the presence of an EHR has become a barrier to recruitment and retention of healthcare workers—and not just of physicians.


If this is true, and I believe it largely is, any claimed benefits of EHR technology must be seriously questioned as to the benefit/cost (downsides) ratio.  This is also NOT what the pioneers who taught me during my Medical Informatics fellowship a quarter-century ago intended, and this deviation from their intentions can be accounted for only by numerous social pathologies I will not get to in more depth in this post.

The following is quite eloquent, expressing the problems in a way I rarely recall seeing so lucidly stated:

Documentation changes have also affected patient care. A patient’s journey through illness and during their stay in hospital is a story or narrative—hence our documentation of that narrative as a history. Our understanding of it in this manner is critical not only to diagnosis and management, but to contextualizing it for the individual patient.

“Progress notes” in the EHR no longer describe progression of disease, but document it rather as an episodic and disjointed accounting of the patient’s condition. And the nursing narrative has been eliminated in favour of checklists of patient experience as data points. As a result, we have lost our holistic knowledge of the patient and his/her illness and are unable to transmit this understanding clearly from one provider to another.  This is detrimental to providing high-quality patient care.

Understanding the crucial differences between narrative of a patient's journey and an episodic, disjointed "data dump" as EHRs now foster is perhaps a capability that differentiates those who were able to get the grades necessary for entry into medical school and succeed there through school, internship, residency and perhaps specialty fellowships, from those with lesser abilities to think abstractly and outside narrow mental confines of datapoints as descriptors of the messy real world.


Focus on the collection and inputting of clinical data or struggling with order entry and documentation further dehumanizes patient care. The interaction of healthcare providers and patients is perhaps the most intimate of relationships outside personal or familial ones. This therapeutic relationship is crucial to providing care, whether for cure or for comfort.


To those whose most intimate relationships are with metal boxes with flashing lights, this issue may also be hard to comprehend fully.


An episode of patient care is now primarily defined by interaction with the computer, which detracts from the provision of care. This experience has been corroborated in a recent study from Calgary, documenting that healthcare workers operating in an EHR environment spend up to 90% of their time during clinical work on the computer rather than with the patient.


I have seen this myself while visiting friends in hospital - banks of nurses lined up against a wall of computer workstations, typing away for the bulk of my visits.    It is - I'm sorry to use this term - nuts, and those who are behind such a system of medical work, managerially speaking, lack both competence and common sense.


... Reliance on order sets developed by experienced practitioners is potentially detrimental for trainees, who do not then have the opportunity to learn the clinical thinking processes that underpin them. Given the reliance on order sets to address inefficiency and safety concerns inherent to the ordering processes in an EHR, physicians at the most crucial stages of learning are not able to develop these critical thinking processes that form the basis for the practice of medicine.


The term of art for this is "deskilling."  I am highly concerned about the quality of young physicians training in cybernetic hospitals, who become automatons without the skills to act appropriately when "off-script" (a rather common occurrence in medicine).


Moreover, given the inefficiency of EHR processes, there is reduced time available for clinical teaching. This has been a universal experience (and complaint) of trainees in Nanaimo. In other jurisdictions, trainees have become effective scribes to unburden staff physicians—an activity I do not believe contributes to the educational experience. Additionally, trainees focus on learning to navigate and use the EHR, rather than attending to patient care or clinical education. We are at risk of producing a generation of physicians with poor clinical skills and who are disconnected from patients.


Medicine is becoming outright enslaved to its cybernetic masters.


The loss of bond with patients is mirrored by disconnection within the healthcare team. EHR processes serve to isolate rather than enhance personal interactions between physicians and nurses, pharmacists and allied health professionals. Healthcare requires collaboration and coordination between many types of providers, a process that is not just crucial to optimal patient care but necessary to support and enhance the performance of individual team members. Disruption of the team approach impairs patient care and has demoralized the healthcare community in Nanaimo.


The social bonds and interactions that hold the complex endeavor of medical care together, in reality, have been usurped by (as I've written before) a grand human subject experiment, without consent of the experimental subjects, namely, clinicians and patients.  Both utopian idiocy and old fashioned opportunism are at work (see "Background On The 'Ecosystem' of Commercial Healthcare IT" at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem).


This has been made worse by the adversarial relationship created when a majority of medical staff who have found continued use of the computerized order management processes unacceptable are opposed by physicians, some allied health professionals and administrators who do not. Some of our most experienced physicians and allied health professionals have retired or changed practice. To say the effects on the health care community in Nanaimo have been destructive is not an understatement. This also means that collaborative work on care needs for our community beyond iHealth has largely stalled.


I believe that the physicians who truly like today's EHRs are in the minority.  As to administrators, if they are not clinicians, they have no business overruling their clinicians on such matters.

What is being eloquently described in this essay is a mass failure of bad health IT that is disrupting medical documentation, medical care (likely resulting in numerous bad outcomes), medical communications, medical education, medical morale, medical esprit de corps, medical recruting and retention, and the health of the community - among others.

Other than those minor drawbacks, everything is fine.

-- SS


Wednesday, May 27, 2015

Government backs down on some requirements for digital medical records

EHR utopian dreams have taken some pronounced hits in recent years.

In recent months, the hyper-enthusiasts and their government allies have had to eat significant dirt, and scale back their grandiose but risible - to those who actually have the expertise and competence to understand the true challenges of computerization in medicine, and think critically - plans.

(At this point I'll give them the benefit of the doubt and not call the utopians and hyper-enthusiasts corrupt, just stupid.)

USA Today published this article today outlining the retreat:

Government backs down on some requirements for digital medical records

Jayne O'Donnell and Laura Ungar, USAToday  
May 26, 2015

Government regulators are backing down from many of their toughest requirements for doctors' and hospitals' use of digital medical records, just as Congress is stepping up its oversight of issues with the costly technology.

They needed to back down because the technology, vastly over-hyped and over-sold as to capabilities, and vastly undersold as to the expertise required for proper design and implementation, has impaired the practice of medicine significantly - and caused patient harms:

... Now the Department of Health and Human Services is proposing a series of revisions to its rules that would give doctors, hospitals and tech companies more time to meet electronic record requirements and would address a variety of other complaints from health care professionals.
"The problem is we're in the EHR 1.0 stage. They're not good yet," says Terry Fairbanks, a physician who directs MedStar's National Center for Human Factors in Healthcare. The federal government "missed a critical step. They spent billions of dollars to finance the implementation of flawed software."

The "EHR 1.0" stage?  The actual problem is that an industry that's existed regulation-free for decades now was believed, against the advice of the iconoclasts, myself included, when it spoke of this experimental technology as if it were advanced and perfected.

Our leaders all the way up to the last two Presidents were suckered by this industry.  In Feb. 2009 I wrote:

http://www.wsj.com/articles/SB123492035330205101

Dear WSJ:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.
The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.


Scot Silverstein, M.D.
Faculty, Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

Nobody was listening.

Back to USA Today:


... William McDade, a Chicago anesthesiologist, checks the medical records of patient Jacob Isham. McDade has moved into electronic medical records but isn't convinced they improve record-keeping, and meanwhile they're expensive and they take time away from patients. 

These digitized records remain the bane of many doctor and patient relationships, as physicians stare at computer screens during consultations.And there's the issue of time. University of Chicago Medicine anesthesiologist William McDade, who has switched from paper to electronic records, says that while EHRs put information at doctors' fingertips, those doctors must take extra time to enter data, and some systems are not intuitive.

The model of physicians as data-entry clerks was experimental from the start, especially in busy inpatient settings and critical care areas.  I opine that particular experiment is a failure.  Paper is far faster, followed by transcription by those without clinical obligations.  That's expensive, of course; but reality is a harsh master.

Praveen Arla of Bullitt County Family Practitioners in Kentucky says even though he's "one of the most tech-savvy people you're ever going to meet," his practice has struggled mightily with its system. It cost hundreds of thousands of dollars to put into place, he says, and it doesn't even connect with other systems in hospitals and elsewhere.

Physicians should not have to be "tech-savvy".  Software, as I've written before, needs to be physician-savvy.  As much of it is written without clinical leadership, we have the results outlined in USA Today.


... The federal government "should've really looked at this more closely when EMRs were implemented. Now, you have a patchwork of EMR systems. There's zero communication between EMR systems," he says. "I am really glad they're trying to look back and slow this down."

I repeatedly called for a slowdown or moratorium of national EHR rollout on this blog.  See 2008 and 2009 posts here and here for example.  My calls were due to the prevalence of bad health IT (BHIT), hopelessly deficient if not deranged talent management practices (especially when compared to clinical medicine) in the health IT industry, and complete lack of regulation, validation and quality control of these potentially harmful medical devices. 

I also called the HITECH stimulus act 'social policy malpractice.'  See my Sept. 2012 post "At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professional".

USA Today then calls out issues of reliability, safety and liability.

Of course, there's always a straddle-the-fence defender of EHRs, with a "EHRs have problems, BUT..." refrain,  even when almost 40 medical societies have complained about safety and usability issues (http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html):

... Physician Robert Wachter, author of The Digital Doctor, is a proponent of,EHRs, but sounded several cautionary notes in his book about the problems. At the University of California San Francisco, where he chairs the department of medicine, a teenage patient nearly died of a grand mal seizure after getting 39 times the dose of an antibiotic because of an EHR-related issue. But Wachter says he believes patients are safer with EHRs than they were with paper.

Wachter's book to my belief omitted known cases of EHR fatality - in my view a milquetoast, spineless approach to EHR risk at best.  (I'm trying to be kind and objective, but such spinelessness of others about EHRs put my mother in her grave, http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html.)

Further, the belief that EHRs are safer than paper are not the views in my mind of a critical-thinking scientist, as the true rates of EHR-related harms is unknown, yet the incidences of mass "glitches" affecting potentially thousands of patients at a time and impossible with paper are well-known.

See my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html), especially points #1 through 4, and the query link http://hcrenewal.blogspot.com/search/label/glitch.

5/27/2015 addendum:  The author of this USA Today article Jayne O'Donnell informed me that the following appeared in the print edition, but not the electronic version:

But Wachter  and Sally Murphy, former chief nursing officer at HHS' health information technology agency, say they both believe patients are safer with EHRs than they were with paper.

"Is there broad proof that electronic health records have impacted quality? No, " says Murphy, "But you just have to pay attention to the unintended consequences and continue to study them."

First, that response seems the classic salesman's tactic of redirection, to deflect from fully answering to the cruel reality of the evidence.  The second part of the response strikes me as a non-sequitur, in fact.

Second, Murphy and Wachter both seem unable to grasp that the myriad en masse risks to potentially large numbers of patients these systems in their current state cause, impossible with paper (as, for instance, in the many posts at the link above), combined with the lack of evidence about (mass-hyped) "quality improvements", could make patients less safe under electronic enterprise command-and-control systems, which in hospitals is what these systems really are.

Try getting thousands of prescriptions wrong, for instance (see http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or stealing hundreds of thousands of paper records (see for example http://hcrenewal.blogspot.com/2012/06/more-electronic-medical-record-breaches.html).

Compare to well-staffed paper systems led by health information management professionals (not IT geeks), especially those supplemented with document imaging systems.

This type of statement - "EHRs are bad today, BUT they're still better than paper" - strikes me as reflecting, I'm sad to say, limited imagination, limited critical thinking, Pollyanna attitudes, and unfettered faith in computers.

Third, Murphy's somewhat disconnected response "But you just have to pay attention to the unintended consequences and continue to study them" is a bit surprising considering the statement made by the same ONC office just a few years ago:

Contrast to former ONC Chair David Blumenthal, see second quote at my April 27, 2015 essay "Pollyanna Rhetoric, Proximate Futures and Realist's Primer on Health IT Realities in 2015" at http://hcrenewal.blogspot.com/2015/04/pollyanna-statements-proximate-futures.html from an April 30, 2010 article entitled "Blumenthal: Evidence of adverse events with EMRs "anecdotal and fragmented":

... The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's [rapidly and on a national scale - ed.] could impede patient safety."  (David Blumenthal, former head of ONC at HHS, http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented)

Sadly and tragically, my mother was seriously injured by EHR-related medication reconciliation failure and abrupt cessation of a heart rhythm medication just weeks after Blumenthal said he was unconcerned about risk and that we should go full steam ahead.  That misadventure began on May 19, 2010 to be exact.

It is my belief HHS and ONC still do not take risk seriously and would revert to a Pollyanna stance in a heartbeat without the pressures of the iconoclasts.

Back to the USA Today article:

... Some proponents of EHRs say the government has been thwarting efforts to improve them.

That's laughable.  A review of Australian computer scientist/informtics expert Jon Patrick's analysis of the Cerner ED EHR product, for example, gives insight into just how crappy this industry and its products are, and government was certainly not the cause.   See: Patrick, J. A Study of a Health Enterprise Information System. School of Information Technologies, University of Sydney. Technical Report TR673, 2011 at http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146.


... In addition to extending the deadline for implementing EHR requirements, a series of HHS proposed rules extends the time doctors, hospitals and tech companies have to meet EHR requirements, cuts how much data doctors and hospitals have to collect and reduces how many patients have to access to their own electronic records from 5% of all their patients to just one person.

"That is a slap in the face to patient rights and all the advocates because we worked so hard and for so long to ensure patients could access their data," says patient advocate Regina Holliday.

Holliday became an electronic records advocate after her husband died of kidney cancer in 2009 at age 39. His care was adversely affected because hospitals weren't reading his earlier EHRs and she had trouble getting access to the records.

I met Regina Holliday in Australia during my 2012 keynote presentation to the Health Informatics Society of Australia on health IT trust (http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html).  As I recently mentioned to her, it's even worse that the requirements for a tamper-proof audit trail are also being relaxed.

Without a complete and secure audit trail, electronic records can be altered without detection by hospitals, e.g., after a medical misadventure, to their advantage.   This represents a massive conflict of interest is a violation of patient's rights to a secure and unaltered record in the event of a mishap, in my opinion.

The 2014 Edition EHR CERTIFICATION CRITERIA, 45 CFR 170.314 spells out in great detail specs for such an audit trail (see page 7 at http://www.healthit.gov/sites/default/files/meaningfulusetablesseries2_110112.pdf), but compliance has been 'conveniently' relaxed, after hospital and industry lobbying I'm sure.

(The certified electronic health record technology definition proposed by CMS would continue to include the “Base EHR” definition found in the “2015 Edition Health IT Certification Criteria” in addition to CMS’ own objectives and criteria.  This definition does not include mandatory tamper resistant audit trails. The audit trail requirement is not proposed to be included in the 2015 definition of “Base EHR."  Neither is this criterion found in CMS’ own definition of CEHRT; rather it is “strongly recommended” that providers ensure the audit log function is enabled at all times when the CEHRT is in use, since the audit log function helps ensure protection of patient information and mitigate risks in the event of any potential breach.)

"Strongly recommended" in this industry in my opinion equates to "safely ignore" if it impacts margins.


... EHRs "have made our lives harder" without improving safety, says Jean Ross, co-president of National Nurses United. Last year, the nurses' union called on the Food and Drug Administration "to enact much tougher oversight and public protections" on EHR use.

Meanwhile, the medical industry is urging HHS to give them even more time and flexibility to improve their systems.

"The level of federal involvement and prescriptiveness now is unhealthy," says Wachter, who chairs the UCSF department of medicine. "It has skewed the marketplace so vendors are spending too much time meeting federal regulations rather than innovating."

Here's Wachter again, in essence, kissing the industry's ass.  Government EHR regulation is still minimal, and prior to MU was nearly non-existent.  Where was the "innovation" (more properly, quality, usability, efficacy and safety) then, I ask?

... Sen. Lamar Alexander, R-Tenn., chairman of the Senate health committee, and Sen. Patty Murray, D-Wash., announced a bipartisan electronic health records working group late last month to help doctors and hospitals improve quality, safety and privacy and facilitate electronic record exchange among health care providers and different EHR vendors.

 "It's a great idea, it holds promise, but it's not working the way it is supposed to," Alexander said of EHRs at a recent committee hearing

 At a Senate appropriations subcommittee meeting last month, Alexander told HHS Secretary Sylvia Burwell that he wanted EHR issues at the top of his committee and HHS' priority list to be addressed through regulation or legislation.

I have spoken to the Senator's healthcare staff, who are aware of my Drexel website and my writings on this blog.  They were stunned by the reality of health IT, and I hope they have relayed my concerns and writings to the senator and that this contributed to his mandate.


... Minnesota lawmakers became the latest state this week to allow health care providers to opt out of using EHRs. But MedStar's Fairbanks says doctors would welcome well-designed, intuitive EHRs that made their jobs easier instead of more difficult — and that would improve safety for patients, too.

It is my view that under current approaches to health IT, in terms of talent management, leadership, product conception, design, construction, implementation, maintenance (e.g., correction of reported bugs), regulation, and other factors, that dream is simply impossible.

The entire EHR experiment needs serious re-thinking, by people with the appropriate expertise to know what they're doing.

I note that excludes just about the entire business-IT leadership of this country, who, lacking actual clinical experience, are one major source of today's problems.



Today, Pinky, we're going to roll out national health IT ... tomorrow, we TAKE OVER THE WORLD!

-- SS

Monday, February 02, 2015

ONC on healthcare IT and patient rights: These systems "have to be rolled out to know where the problems lie"

An anonymous commenter to my blog post about the USA Today article on bad health IT (http://hcrenewal.blogspot.com/2015/02/former-onc-director-david-blumenthal.html) noted this, that I myself missed:

Anonymous said...

Gettinger's comment is stunning, especially coming from a director of safety and quality for HHS' Office of the National Commissioner for Health Information Technology:

 "You don't just plunk down EHRs and everyone's happy. You use an incremental kind of approach (and) that takes time, that takes energy and that takes effort," he says, adding that they have to be rolled out to know where the problems lie.

February 1, 2015 at 9:17:00 PM EST Delete

(Writing of ONC's Acting Director Andrew Gettinger MD, Office of Clinical Quality and Safety, http://www.healthit.gov/newsroom/andrew-gettinger-md.)

If quoted accurately, that's likely the end of the line for me regarding ONC and any concerns about patients' rights.  Patients are to be used as live subjects to debug software.

That is advocating human subjects experimentation without informed consent with a technology known to cause increased risk, harm and death, and there's nothing to debate there.  This statement would be perhaps appropriate for someone writing about animal experimentation. 

My own mother's dead, in fact, from that type of attitude.

Gettinger's statement will serve as the cover slide to my upcoming legal presentations to American Association for Justice state chapters and at the AAJ national meeting later this year, as well as to the Association of Health Care Journalists (AHCJ), to which I've been invited to speak.

-- SS

Wednesday, October 29, 2014

"The tragedy of electronic medical records"

The Indianapolis Business Journal has published this article, citing former head of Indiana University's Regenstrief Institute, a world leader in EHR research, Dr. Clem McDonald:

The tragedy of electronic medical records
October 23, 2014
J.K. Wall
http://www.ibj.com/blogs/12-the-dose/post/50131-the-tragedy-of-electronic-medical-records

It wasn’t supposed to work out this way.

Digitizing medical records was supposed to transform health care—improving the quality of care and the service provided to patients while helping cut out unnecessary costs. Just like IT revolutionized all other industries.

Perhaps they still will. But lately, electronic medical record systems are getting nothing but votes of no-confidence from physicians, hospitals, insurers and IT experts.

Dr. Clem McDonald, who did more than anyone to advance electronic medical records during his 35 years at the Indianapolis-based Regenstrief Institute, called the 5-year, $27 billion push to roll out electronic medical records “disappointing” and even a “tragedy” last month during a talk with health care reporters (including me) at the National Institutes of Health in Bethesda, Maryland.

I agree with those sentiments.  The botched industry approach to clinical information technology has set back the cause of good health IT severely, largely through clinician disenfranchisement.  That dissatisfaction and disappointment will not be easy to reverse - and never should have needed to have been reversed.

... “It’s sort of a tragedy because everybody’s well-intentioned,” said McDonald, who spearheaded one of the nation’s first electronic medical record systems at Regenstrief and what is now Eskenazi Health. McDonald’s work in Indianapolis on the electronic exchange of medical records put patients here at least a decade ahead of those in most of the country in benefiting from the technology.

I'm not so sure that perverse behaviors such as willful blindness to the risks, profiteering, and indifference to harms caused by these systems, as I've documented at this blog and elsewhere count as "well-intentioned" (e.g., "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

... McDonald now has a nationally influential post to promote electronic medical records, as the director of the Lister Hill Center for Biomedical Communications, a part of the National Library of Medicine, which is one of the National Institutes of Health.

During his talk, McDonald released his latest research survey, which found that electronic medical records “steal” 48 minutes per day in free time from primary care physicians.

That may be true regarding data entry time.  I'd say the amount is likely more when accounting for confusion and communications difficulties that bad health IT causes.

... One-third of physicians surveyed said it took longer to find and review medical record data. One-third also said it was slower to read other clinicians’ notes.

Some docs don’t even read reports any more. This is a perverse side effect,” McDonald said, noting that the electronic reports have so much information in them, that they become “endless and mindless.”

I have used the term "perverse" in the past regarding commercial health IT; this is the first time I recall seeing the term from one of the EHR pioneers.

... More bad news about electronic health records came out this week in a new research study. It found that physicians using electronic medical records spend an extra 16 minutes per day, on average, doing administrative tasks than their peers who still use only paper.

The study relied on data from 2008—which when compared with McDonald’s study suggests EMRs are now consuming more of doctors’ time than they were before the federal push to expand their use.

“Although proponents of electronic medical records have long promised a reduction in doctors’ paperwork, we found the reverse is true,” wrote study authors Steffie Woolhandler and David Himmelstein.
  
Yet we still hear promises about "increased efficiency" and reduction of clinicians' administrative tasks and paperwork due to health IT.  When will that canard be put to rest, one might wonder?

In my view, the experiment of making clinicians perform EHR clerical work has been a failure.

And it was, in fact, an experiment in the full sense of the word.  It was done with little clue as to the true effects on patient care.

From the article:

... So with so many so upset with electronic health records, why is McDonald still optimistic?

He thinks the problems folks are having aren’t inherent to the technology itself, but are instead caused by overly restrictive rules coming both from the federal government and from hospital systems.

Hospital systems, knowing that more information can be recorded now that it’s electronic, have insisted that doctors do more documenting. McDonald cited one research study that found that documentation requirements have doubled in the past decade.

“I think they’ve got to ask less,” McDonald said of hospital administrators. “Nobody has any idea of the time-cost of one more data entry.”

I don't share that optimism or a belief physicians will be asked to "do less" with EHRs, since physicians have essentially abrogated their professional independence and autonomy, and are increasingly becoming servants of their business-degree masters - and of bad technology.

At least nurses are fighting back, e.g., per National Nurses United (see query link http://hcrenewal.blogspot.com/search/label/National%20Nurses%20United).

-- SS

Sunday, December 23, 2012

ONC's Christmas Confessional on Health IT Safety: "HIT Patient Safety Action & Surveillance Plan for Public Comment"

This time of year is certainly appropriate for a confessional on the health IT industry and hyperenthusiasts' sins.

In the first report I've seen that seems genuinely imbued with a  basic level of recognition of social responsibility incurred by conducting the grand human subjects experiment known as national health IT, ONC has issued a Dec. 21, 2012 report "Health Information Technology Patient Safety Action & Surveillance Plan for Public Comment." It is available at this link in PDF.

Statements are made that have appeared repeatedly since 2004 at this blog, and my health IT difficulties site that went online years before this blog (1998 to be exact); it is possible through my early writing and that of like-minded colleagues that we were the origin of most of these memes.  We wrote them with the result of bringing much scorn upon ourselves. After all, "how could health IT possibly not be a panacea?" was the "you are an apostate" attitude I certainly experienced (e.g., as in my Sept. 2012 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture").

Observations echoed in the new ONC report:

  • "Just as health IT can create new opportunities to improve patient care and safety, it can also create new potentials for harm."
  • Health IT will only fulfill its enormous potential to improve patient safety if the risks associated with its use are identified, if there is a coordinated effort to mitigate those risks, and if it is used to make care safer.
  • Because health IT is so tightly integrated into care delivery today, it is difficult to interpret this initial research [such as the PA Patient Safety Authority study  - ed.], which would seem to suggest that health IT is a modest cause of medical errors. However, it is difficult to say whether a medical error is health IT-related. [Not emphasized, as I wrote here, is the issue of risk when, say, tens of thousands of prescriptions are erroneous due to one software bug, a feat impossible with paper - ed.]
  • The proper steps to improve the safety of health IT can only be taken if there is better information regarding health IT’s risks, harms, and impact on patient safety.

Suggested steps to be taken include:

  • Make it easier for clinicians to report patient safety events and risks using EHR technology.
  • Engage health IT developers to embrace their shared responsibility for patient safety and promote reporting of patient safety events and risks. [I am frankly amazed to see this admission.  In the past, that sector excused itself entirely on the basis of the "learned intermediary" doctrine and "hold harmless" clauses; where the clinician is an all-knowing Deity between computer and patient.  I've been writing for years, however, that the computer is now the intermediary between clinician and patient since all care 'transactions' have to traverse what is now an enterprise clinical resource and clinician control system - ed.]
  • Provide support to Patient Safety Organizations (PSOs) to identify, aggregate, and analyze health IT safety event and hazard reports.
  • Incorporate health IT safety in post-market surveillance of certified EHR technology
  • Align CMS health and safety standards with the safety of health IT, and train surveyors.
  • Collect data on health IT safety events through the Quality & Safety Review System (QSRS).
  • Monitor health IT adverse event reports to the Manufacturer and User Facility Device Experience (MAUDE) database. [I've been promoting the use of MAUDE for just that purpose, and much more regarding documenting and reporting on mission-hostile health IT; see this post - ed.]

These steps are to be taken in order to "Inspire Confidence and Trust in Health IT and Health Information Exchange."

The title of my keynote address to the Health Informatics Society of Australia this summer was, in fact, "Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step".

My thoughts on this report:

  • It is at least two decades overdue.
  • It was produced largely if not solely due to the pressure of the "HIT apostates", finally overcoming industry memes and control of information flows through great perseverance.
  • It is indeed a confessional of the sins committed by the health IT industry over those decades.  Creating, implementing and maintaining mission critical software in a safety-cognizant way is not, and was not, a mystery.  It's been done in numerous industries for decades.
  • It is still a bit weak in acknowledging the likely magnitude of under-reporting of medical errors, including HIT-related, in the available data, and the issue of risk vs. 'confirmed body counts' as I wrote at my recent post "A Significant Additional Observation on the PA Patient Safety Authority Report -- Risk".
  • It is unfortunate that this report did not come from the informatics academic community in the United States, i.e., the American Medical Informatics Association (AMIA).  AMIA's academics have done well in advancing the theoretical aspects of the technologies, and how to create "good health IT" and not "bad health IT."  However, they have largely abrogated their social responsibilities and obligations, including but not limited to those of physicians, in ensuring the theories were followed in practice by an industry all too eager to ignore academic research (which, in order to follow, utilizes money and resources and reduces margins).
(On the latter point, just last week did the American College of Medical Informatics [ACMI] refuse to permit me to be a speaker at their early 2013 annual retreat despite support from some of its members.)

And this:

  • If the industry and the academics had been doing their job responsibly, I might be spending this Christmas and New Years's holiday with my mother, rather than visiting her in the cemetery.

All that said, the report is welcome.

Finally, it is hoped - and expected - that public comments will indeed be "public", and that any irregularities in such comments (such as appeared in the public comments period for MU2 due to industry ghostwriting as in my Aug. 2012 post "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" and Sept. 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?") will be reported and acted upon in an aggressive manner.

And finally, from the Healthcare Renewal blog, Merry Christmas.

-- SS