Showing posts with label healthcare IT risk. Show all posts
Showing posts with label healthcare IT risk. Show all posts

Friday, May 12, 2017

Massive ransomware cyberattack in U.K. Hits 16 Health Institutions, many doctors reported that they could not retrieve their patients’ files, but not to worry - no patient information was looked at or compromised

Perhaps doctors and nurses are clairvoyant?  Who needs records, anyway?

Cyberattack in U.K. Hits 16 Health Institutions
New York Times











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


Saturday, October 01, 2016

Our ED wait times wil be longer than usual this weekend (and beyond) so we can attend to the computer.

A hospital system, Pinnacle Health, not all that far from me in the Harrisburg, PA area is rolling out EPIC this weekend.

The following banner is at the top of their homepage at http://www.pinnaclehealth.org/locations-and-providers/:


ALERT: Due to our transitioning of a new computer system this weekend, ER wait times may be longer than normal.  Click to enlarge.

! ALERT: Due to our transitioning of a new computer system this weekend, ER wait times may be longer than normal. If you have a minor illness that doesn’t require a trip to the ER, you can visit one of our Express or FastCare clinics or if unsure where to go, contact our free 24/7 Nurse Advice Line at (717) 988-0074


So, besides delaying affairs in a critical care environment, in order to take care of the computer's needs, they're asking patients to decide if they have "a minor illness that doesn't require a trip to the ER" and, in so doing, redirecting patients with possibly serious problems to a doc-in-the-box urgicare center.

These two matters raise risk on its face.  If patients are harmed or die, then, are their injuries or death considered a worthy sacrifice in the name of achieving cybernetic utopia?

It would seem far more logical - and safe - to roll out a "new computer system" gradually, in a manner that does not require crazy workarounds (e.g., asking patients to decide if they need the ER or not) and causing delays and confusion that, in an ED environment, can and do lead to missed findings, lost information, harm, and death.

This mayhem will go on for far longer than a weekend.

It's stunning how the naive public has been sold the myth/fantasy that computers are a really great thing in medicine, and worth the risks of a massive rollout and the disruptions that causes, when increasingly - as posted in numerous essays on this website and others - the data does not support such declarations, and computers serve as more of a distraction than a boon to busy clinicians.

-- SS



Wednesday, June 22, 2016

Reckless indifference to nurse's concerns about bad health IT results in showing her the door?

At numerous past posts I referred to hospital executives' reckless indifference to the concern of seasoned clinicians about bad health IT, such as at  http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html and  http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html and other posts.

I now see a stunning story of the results of EHR iconoclasty and patient advocacy:

CNO claims hospital forced her out after she raised concerns about EMR
Becker's Hospital Review
Written by Akanksha Jayanthi  
June 14, 2016 
http://www.beckershospitalreview.com/legal-regulatory-issues/cno-claims-hospital-forced-her-out-after-she-raised-concerns-about-emr.html

 A former nursing executive at Sonoma West Medical Center in Sebastopol, Calif., has filed a lawsuit against the hospital, alleging she was fired after raising concerns the EMR was a threat to patient safety, reports The Press Democrat.

Autumn AndRa, RN, was serving as CNO of the hospital when she approached CEO Ray Hino and said the EMR, called Harmoni, was unsafe, according to the report.

Ms. AndRa was reportedly terminated from her CNO position April 14 and was offered a position in the intensive care unit, which her attorney Daniel Bartley told The Press Democrat would have been a demotion. Ms. AndRa left the hospital due to alleged harassment, according to Mr. Bartley.

If these allegations are true, a clinician, the Chief Nursing Officer, was shown the door in an act of recklessness for her complaining about bad health IT.

Some definitions: 

Bad health IT:

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.   

Reckless indifference:

Deliberate indifference is the conscious or reckless disregard of the consequences of one's acts or omissions. It entails something more than negligence, but is satisfied by something less than acts or omissions for the very purpose of causing harm or with knowledge that harm will result.

A wrongful termination lawsuit was apparently filed:

... The lawsuit alleges the EMR system mixes patients' records, so information in one patient's chart moves to another patient's chart. It also alleges the EMR has issues tracking and updating patient medications and does not display patient code status information, which informs providers of patients' desired medical interventions, according to the report.

These types of gross defects, if true, represent an on its face menace to patient safety.

Further, these issues (and the harm that may result) are well known.  In fact ONC's contractor RIT just released a comprehensive review article on health IT problems (see "Report of the Evidence on Health IT Safety and Interventions", May 2016, at https://www.healthit.gov/sites/default/files/task_8_1_final_508.pdf).

CEO Ray Hino had the usual refrain seen in so many postings here (under the blog query "Patient care has not been compromised" - http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised):

Mr. Hino told The Press Democrat the EMR did not pose any danger to patients, and no patients have been harmed because of software defects.

Like most others uttering that line, as I've documented, Mr. Hino apparently lacks expertise (e.g., in clinical, IT or Medical Informatics domains) to render such a judgment about patient danger if the EHR did or does exhibit such problems.  His bio is at https://www.linkedin.com/in/raymondhino.

As to whether patients were harmed, that is irrelevant if the EHR has such defects.  Sooner or later, they will be.  The issue is risk, not body counts (yet).

There's also this.  The EHR in question is not the product of the major EHR vendors but the work of apparent insider.  See http://about.harmonimd.com/usa/ referencing just two implementations, one at Somona West Medical Center, California, the subject of this post, and one at the Kilimanjaro Christian Medical Centre, Tanzania, Africa:

... The lawsuit also names Dan Smith, the developer of the EMR software in question, as a defendant. According to the lawsuit, Mr. Smith "has engaged in retaliation against [Ms. AndRa] and other employees who have voiced concerns that Mr. Smith's electronic medical records system, his self-dealing, and his management of medical and financial decisions are not in the best interests of SWMC and pose life-threatening risks to patient care," reports The Press Democrat.

Not only did Mr. Smith develop the software in question, but he is a significant financial backer and influencer at SWMC. According to a 2015 report from The Press Democrat, Mr. Smith and his wife have contributed nearly $9 million to the hospital in donations and forgivable loans, and he plays a role in "ever major decision" regarding the hospital. Mr. Smith is on SWMC's board of directors. 

I really don't think injured or dead patients (or juries) will find those relationships an excuse for bad health IT, what seems like a clinical trial of new IT by a private company and owner without informed consent (including divulging to patients and users a possible COI), and the discharge of someone complaining about it.

Mr. Smith and hospital officials declined to comment on the lawsuit, citing pending litigation, according to the report.

My expertise is available should the parties so desire.

-- SS

6/21/2016 Addendum:
https://en.wikipedia.org/wiki/Human_subject_research 

Human subjects

The United States Department of Health and Human Services (HHS) defines a human research subject as a living individual about whom a research investigator (whether a professional or a student) obtains data through 1) intervention or interaction with the individual, or 2) identifiable private information (32 C.F.R. 219.102(f)). (Lim, 1990)[2]

As defined by HHS regulations:

"Intervention"- physical procedures by which data is gathered and the manipulation of the subject and/or their environment for research purposes [45 C.F.R. 46.102(f)][2]

"Interaction"- communication or interpersonal contact between investigator and subject [45 C.F.R. 46.102(f)])[2]

"Private Information"- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public [45 C.F.R. 46.102(f)] )][2]

"Identifiable information"- specific information that can be used to identify an individual[2]

Human subject rights

In 2010, the National Institute of Justice in the United States published recommended rights of human subjects:
  • Voluntary, informed consent
  • Respect for persons: treated as autonomous agents
  • The right to end participation in research at any time[3]
  • Right to safeguard integrity[3]
  • Benefits should outweigh cost
  • Protection from physical, mental and emotional harm
  • Access to information regarding research[3]
  • Protection of privacy and well-being[4]

-- SS

Tuesday, June 07, 2016

NY Times/Steve Lohr asks "Why the Economic Payoff From Technology Is So Elusive." The answer in medicine is obvious.

In a June 5, 2016 article, New York Times reporter Steve Lohr (http://topics.nytimes.com/top/reference/timestopics/people/l/steve_lohr/index.html), who reports on technology, business and economics, asked the following question:

Why the Economic Payoff From Technology Is So Elusive
New York Times, Business Day
By STEVE LOHR
JUNE 5, 2016
http://www.nytimes.com/2016/06/06/business/why-the-economic-payoff-from-technology-is-so-elusive.html

Your smartphone allows you to get almost instantaneous answers to the most obscure questions. It also allows you to waste hours scrolling through Facebook or looking for the latest deals on Amazon.  More powerful computing systems can predict the weather better than any meteorologist or beat human champions in complex board games like chess.

But for several years, economists have asked why all that technical wizardry seems to be having so little impact on the economy. The issue surfaced again recently, when the government reported disappointingly slow growth and continuing stagnation in productivity. The rate of productivity growth from 2011 to 2015 was the slowest since the five-year period ending in 1982.

Healthcare becomes the gravamen of the article:

One place to look at this disconnect is in the doctor’s office. Dr. Peter Sutherland, a family physician in Tennessee, made the shift to computerized patient records from paper in the last few years. There are benefits to using electronic health records, Dr. Sutherland says, but grappling with the software and new reporting requirements has slowed him down. He sees fewer patients, and his income has slipped.

Unfortunately, the advisors who helped him with the article may have provided incomplete information:

... “The government funding has made a huge difference,” said Dr. Ashish Jha, a professor at the Harvard School of Public Health. “But we’re seeing little evidence so far that all this technology has had much effect on quality and costs.”

In the face of, among many others, a stunning letter from 40 medical societies to HHS in 2015 that the technology is unfit for purpose (http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf), known and hair-raising defects (http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and many other complaints from physicians and nurses (e.g., http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html, http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html, query link http://hcrenewal.blogspot.com/search/label/glitch as just a few examples), such a statement is anserine.

Why would anyone expect (good) effects on "quality and costs" of healthcare when the technology is so unfit for purpose in design and implementation that it has alienated most of its users?  

I've written previously about Jha's views in a May 27,  2009 post "Harvard's EMR Justification: We Just Have To Do Something" (http://hcrenewal.blogspot.com/2009/05/harvards-emr-justification-we-just-have_27.html):

 ... "I'm not suggesting EHR is going to be a panacea, but the one thing that is absolutely true is there is nothing else out there now that has any more political appeal," Jha says. "Everybody agrees, whether you are a conservative, moderate, or liberal, that we have to do something about healthcare. So the one place where we can all come to agreement is we have to do something about electronic records."

I do not think "political appeal" is a good justification for a multi-billion dollar cybernetic experiment in medicine, where the risks of the technology are considerable and where basic healthcare needs are not being well met among the poor and underprivileged.

Former ONC Chair David Brailer is quoted:

“People confuse information automation with creating the kind of work environment where productivity and creativity can flourish,” said Dr. David J. Brailer, who was the national health technology coordinator in the George W. Bush administration. “And so little has gone into changing work so far.”

Brailer was little better than Jha, and moves the goalposts with a type of circular logic.  He appears to be saying that technology that will revolutionize medicine can't work until we change how things are done in medicine so the technology can revolutionize medicine. 

The article then quotes one Tennessee physician, a Dr. Sutherland, who is "happy" to accept bad health IT, a resultant pay cut, and increased work:

... Today, Dr. Sutherland’s personal income and the medical group’s revenue are about 8 percent below where they were four years ago. But in 2015, both his earnings and the revenue of Healthstar, which employs 350 people in 10 clinics, increased slightly, by nearly 3 percent from 2014.

... Dr. Sutherland bemoans the countless data fields he must fill in to comply with government-mandated reporting rules, and he concedes that some of his colleagues hate using digital records. Yet Dr. Sutherland is no hater. Despite the extra work the new technology has created and even though it has not yet had the expected financial payoff, he thinks it has helped him provide better information to patients.

He values being able to tap the screen to look up potentially harmful drug interactions and to teach patients during visits. He can, for example, quickly create charts to show diabetes patients how they are progressing with treatment plans, managing blood glucose levels and weight loss.

He is working harder, Dr. Sutherland says, but he believes he is a better doctor. Blunt measures of productivity, he added, aren’t everything. “My patients are better served,” he said. “And I’m happier.”

While being able to provide fancy charts and check drug-drug interactions (for which a massive and expensive EHR is certainly not needed; a PDA will suffice) is fine.

However, anyone who gladly accepts a pay cut, and inconvenience, and harder work due to bad health IT, and is a happy camper with that state of affairs, either suffers from the Stockholm syndrome or has a lot of discretionary income and free time to spare that many clinicians do not.  

The article fails to mention the hundreds of thousands of other US docs and others in other lands (e.g., http://hcrenewal.blogspot.com/2016/05/hit-mayhem-canadian-style-nanaimo.html) who aren't happy at all with health IT as it is today.  

---------------------------------------

I sent this email to Mr. Lohr.

From: S Silverstein
To:Steve Lohr 
Date: Tue, Jun 7, 2016 at 10:02 AM
Subject: Re: Why the Economic Payoff From Technology Is So Elusive

Dear Mr. Lohr,

In medicine, the answer to this question is straightforward.  I don't know if Ashish Jha brought this to your attention, or if he himself is aware of it.

This letter from nearly 40 different medical societies to HHS about bad health IT is specific about how bad the current health IT is:



You should be aware of the letter's contents.  I've also attached it to this email.

In academic Medical Informatics, such matters are often ignored, as they run contrary to the narrative that IT will "revolutionize medicine"; I know, as I was Yale faculty in Medical Informatics myself. 

The assumption in academic circles and in the Administration (unfortunately) is that "all health IT is good health IT." 

Unfortunately, it is not.  From my own site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at http://cci.drexel.edu/faculty/ssilverstein/cases/ :

Definitions authored by myself and Australian informatics expert Dr. Jon Patrick:


Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, can be easily, substantively and cost-effectively customized to the needs of medical specialists and subspecialists, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. 

Bad Health IT ("BHIT") is defined as 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, is lacking in evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

It comes as no surprise not to find productivity gains, but instead hundreds of thousands of angry physicians (and nurses), when health IT is mostly bad IT.

The health IT industry itself needs serious remediation before its products will be a boon to medicine.

Sincerely,
Scot Silverstein, MD
Drexel University, Philadelphia


p.s. I have not even broached the matter of health IT patient harms. 

Patients are being harmed and dying of bad health IT.  See for instance the CRICO insurance report at http://www.cci.drexel.edu/faculty/ssilverstein/PSQH_MalpractClaimsAnalyConfirRisksEHR.pdf
 
---------------------------------------  

I will add an addendum if I receive a reply.

-- SS