An "Anecdotal Complaint" About An ICU EHR

An "anecdotal complaint" (see health IT-specific definition of 'anecdotal' at this link) from a practicing medical informaticist on an EMR system being rapidly rolled out - in a neonatal ICU, where a single slip is an ended life or lifelong crippling injury, and a multimillion dollar lawsuit, in the making:

... Having just exited a 4 week “Night call” rotation of q3 nights (16 hours in house) or weekend days (16-26 hour shift in house) call / attesting/checking and signaturing horror show, my first with our “New” {#$@#**%%$@!*&!!*} charting and attesting, etc system [symbolic praise in the original - ed.], I can 100% attest that everything [another colleague -ed.] said is exactly why I’m scared to death of all the UCs [unintended consequences - ed.] of this current effort, when adult outpatient systems hit quaternary NICUs of 50-60 patients, with untested crash [i.e., artificially rushed - ed.] rollouts.

Dozens and dozens>>>>thousands of examples of each and every comment [made by the other colleague on EHR problems - ed.], plus more is exactly what I’m personally suffering. The more is bilateral horrible carpel tunnel flare ups (7-10 clicks and scrolls to get an “overview” of anything) so right now both my hands are numb.

Plus, one to two minute logons, is a lifetime when a baby is suddenly crashing. This is a “coding horror” and a safety nightmare. I live in constant fear of somebody screwing up something important, and perhaps uncorrectable. We do our work in real-time, most of the time. Where is the FDA when you need them? [Scared of hot potatoes as I wrote here - ed.]

And we do still talk to each other – but even that doesn’t always “work out”, because we’ve lost our operational minds (collectively) – the shared-by-all compact, visually all data in one place, and temporally arranged – i.e., the shared nurse/doc/resp flowsheet [traditionally in an ICU, a long tabular scroll of paper for "at a glance" patient status overview - ed.] – where everybody was looking at the same page, which we no longer are – as the team is slowly discovering.

And which required no logon for sign-over bedside rounding (~40 minutes for 20-30 babies was the allotted time). The flowsheet needed only a 10-15 second glance to spot developing problems; “the computer” is effectively inaccessible in the time allotted for the twice daily sign-n-out “rounds”.

A traditional ICU flowsheet (click to enlarge)

One wonders how often this scenario - what I now call a "But ... patient safety is not compromised" scenario in the words of the typical hospital administrator - is being repeated around the country.

Of course, the problem just can't be the software (as in the post at this link). It's those dullard clinicians and hospital IT staff who have misconfigured the cybernetic miracle.

This is certainly an example where the customs, traditions and methodologies of business IT (e.g., implement on-time and on-budget, at all costs, according to a strict timeline with benchmarks) are highly ill-suited for medicine. That assumes that there are not kickbacks or other financial 'incentives' or COI's in play, of course.

In fact, it would not surprise me if the IT vendor, a major company, has insulated itself from liability through a "hold harmless " clause. If so, as I have written in 2009 in JAMA at this link in response to an article by Koppel and Kreda [1], and at my Drexel Univ. health IT difficulties site at this link, having signed such a clause would represent a breach of hospital governance's fiduciary responsibilities to their clinical employees and agents (in effect, laying the liability for EHR-induced malpractice solely on them), and to patients.

I advised this doctor to 'be safe', as I would not want to have to be expert witness for a plaintiff whose child they injured or killed due to EHR-mediated obstacles to accepted professional standards of healthcare.

Finally, if this doctor were to resign, perhaps a case could be made for constructive discharge.

-- SS

[1] Health Care Information Technology Vendors' “Hold Harmless” Clause Implications for Patients and Clinicians. Koppel R, Kreda B. JAMA. 2009;301(12):1276-1278. doi:10.1001/jama.2009.398

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NIST on the EHR Mission Hostile User Experience: Blame the User? Nyet...

I have often had to respond to those who claim that EHR's don't cause medical errors, users do. That subset of the health IT irrationally exuberant seem common in the health IT industry and pundit channels.

NIST (The U.S. National Institute of Standards and Technology) has recently issued a draft report "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).

The report is quite negative concerning the low usability of today's commercial health IT, and recommends significant improvements that have been standard practice in other mission- and life-critical IT sectors for decades.

I will have more to write about this report, but I found a passage and footnote early in the report striking.

Of note, from the new NIST draft report:

This passage, from page 10:

The EUP (EHR usability protocol) emphasis should be on ensuring that necessary and sufficient usability validation and remediation has been conducted so that use error [3] is minimized.

[3] “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.

This passage describes what I have termed a mission hostile user experience.

"Blame the user" as the default, reflex reply to clinical IT-related medical errors, and the "hold vendor harmless for defects" clauses that facilitate this excuse are now heading to the junkpile - in the clinic, hospital, and courtroom.

It is my hope that the the Wild West, free-for-all, cavalier, get out of jail free days of the health IT industry are coming to a close.

Hint to health IT industry: you may actually need to invest in people who know what they're doing, instead of hiring the cheapest labor possible. (See, for example, my Aug. 2010 post
"EPIC's outrageous recommendations on healthcare IT project staffing" for more on that issue.)

-- SS

Oct. 25, 2011 Addendum:

This comment (#5, October 25th, 2011 at 12:38 pm) by "a practicing front-end designer and application developer" over at HIStalk is quite interesting. The writer points out the differences between designers and developers, and opines that:

If you’re going to improve vendor design, it has to begin with an internal commitment to value designers and what they contribute to the product development process. They can not be an afterthought. There are very few companies with this mindset. Almost all HIT companies are developer-driven, so the first thought, and one that is promoted in this report, is to turn developers into designers. This will not work! A developer and a designer require two fundamentally different skill sets that are not easily transposed. Developers are trained to think rationally and analytically; design requires empathy for the user.

In health IT, empathy for the patient as well, I might add.

-- SS

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Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT

I am both surprised and pleased to read the new report of an American Medical Informatics Association (AMIA) task force, in the form of an AMIA Board Position Paper released today entitled:

"Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force." Goodman, Berner, Dente, Kaplan, Koppel et al. for the AMIA Board of Directors. J Am Med Inform Assoc (2010). doi:10.1136/jamia.2010.008946.

A free PDF is available at this link.

This report may be part of a trend. As I wrote recently at this link:

I was somewhat taken aback by the appearance of the article by Karsh et al. entitled "Health information technology: fallacies and sober realities" (covered at Healthcare Renewal here) in the Oct. 2010 Journal of the American Medical Informatics Association (JAMIA).

I was taken aback since the article rains heavily on the academic memes of healthcare IT as a benign and deterministic solution to healthcare's ills, and of health IT-related adverse outcomes being mere "anecdotes."

It appears that the views on healthcare IT safety, ethics, management practices, etc. appearing on the Healthcare Renewal blog and on my once-controversial academic health IT website "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" (started in 1999) are now becoming mainstream.

Most of the issues in this new AMIA Position Paper have been written about at this blog since 2004, and at my aforementioned academic HIT website since 1999. I will reproduce the abstract of the paper below, but download and read the entire paper (emphases mine):

ABSTRACT
The current commercial health information technology (HIT) arena encompasses a number of competing firms that provide electronic health applications to hospitals, clinical practices, and other healthcare-related entities. Such applications collect, store, and analyze patient information. Some vendors incorporate contract language whereby purchasers of HIT systems, such as hospitals and clinics, must indemnify vendors for malpractice or personal injury claims, even if those events are not caused or fostered by the purchasers. Some vendors require contract clauses that force HIT system purchasers to adopt vendor-defined policies that prevent the disclosure of errors, bugs, design flaws, and other HIT-software-related hazards. [The "gag clauses." These are exceptionally unethical, in my view, regarding the use of an experimental technology, healthcare IT, on unsuspecting, unconsented patients unaware of health IT risks - ed.] To address this issue, the AMIA Board of Directors appointed a Task Force to provide an analysis and insights. Task Force findings and recommendations include: patient safety should trump all other values [I've been writing and saying this for many years now - ed.]; corporate concerns about liability and intellectual property ownership may be valid but should not over-ride all other considerations; transparency and a commitment to patient safety should govern vendor contracts; institutions are duty-bound to provide ethics education to purchasers and users, and should commit publicly to standards of corporate conduct; and vendors, system purchasers, and users should encourage and assist in each others’ efforts to adopt best practices. Finally, the HIT community should re-examine whether and how regulation of electronic health applications could foster improved care, public health, and patient safety. [Regulation has been another issue I have focused upon, especially after holding a management role in Big Pharma - ed.]

Also notable was this proclamation:

... “Hold harmless” clauses in contracts between Electronic Health Application vendors and purchasers or clinical users, if and when they absolve the vendors of responsibility for errors or defects in their software, are unethical. [I note that, somewhat remarkably, this is not the more typical hedged academic "may be unethical" statement- ed.] Some of these clauses have stated in the past that HIT vendors are not responsible for errors or defects, even after vendors have been informed of problems.

Unethical, indeed, as per my JAMA letter of July 22, 2009 on that issue entitled "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" (link) and per my more detailed essay at my Drexel HIT website (link).

Also remarkable were these statements:

... For-profit manufacturers of healthcare products are bound by values which may at times conflict. For instance, as entities in a marketplace, they are duty-bound to provide a financial return to those investors who have contributed resources in anticipation of their success. Yet, as developers and manufacturers of products that affect the health of people, they are no less obligated to ensure, to the extent possible, that their products are safe and effective, and beneficially support patients [that goes without saying - ed.] and those who treat and care for them. [That is, clinicians, who through their unpaid hard work using oft ill-designed HIT systems are currently used as beta testers and, through 'hold harmless' clauses, as an insurance company and, quite frankly, as cannon fodder - ed.]

... Contracts should require that system defects, software deficiencies, and implementation practices that threaten patient safety should be reported, and information about them be made available to others, as appropriate. Vendors and their customers, including users, should report and make available salient information about threats to patient safety [I've also been writing this for years; it's common sense - ed.] resulting from software deficiencies, implementation errors, and other causes. This should be done in a way easily accessible to customers and to potential customers. This information, when provided to customers, should be coupled with applicable suggested fixes, and should not be used to penalize those making the information available. [There should be as little fear of reporting HIT problems as in reporting medication problems - ed.]

... If appropriate for their size and mission, vendors and client institutions contribute to the growth of biomedical knowledge by conducting HIT research [including research on how to remediate the HIT itself and the IT industry creeds, customs and traditions that cause suboptimal design and implementation in the first place - ed.] … authors of scientific reports should not be prevented from identifying devices, tools, and systems by name in publications.

… There are situations in which HIT vendors pursue joint marketing agreements with institutions that adopt vendors’ products and by which these institutions become a part of the vendors’ marketing program [I believe that hospitals should never allow themselves to become IT marketing and promotion operations - ed.], often in exchange for discounts, payments, stock options, or favorable treatment by the vendor. In at least some cases, these agreements include provisions whereby healthcare institutions that serve as demonstration sites for particular products receive compensation when other institutions adopt products from the same vendor. The Task Force notes that such agreements might place the “referring” institutions in a conflict of interest [a common topic on this blog -ed.], and therefore recommends that:

• Any such conflicts should be eliminated or managed, including disclosure, according to current standards.

• Where such agreements are made, they should include a provision whereby any payment or other compensation contingent on the sale of a system to another party must be disclosed to that other party.

• Payments or gifts to individuals and institutions, including institutional officials, clinicians, etc, should be disclosed. Alternatively, they should be addressed by entities’ internal mechanisms for managing conflicts of interest and commitment, perhaps along the lines of the “rebuttable presumption” standard endorsed by the Association of American Medical Colleges. The goal of the standard is “to ensure that institutions systematically review any financial interest that might give rise to the perception of a conflict of interest, and further, that they limit the conduct of human subjects research by financially interested individuals to those situations in which the circumstances are compelling.

The new AMIA Position Paper and the aforementioned paper on HIT fallacies and realities seem to reflect a welcome transformation or even about-face for AMIA. I am likely considered "radioactive" by some in that organization for espousing similar views dating back to the late 1990's, when expression of such views was uncommon and even frowned upon. Academia has not been highly tolerant of heterodoxy in many domains for quite some time.

One wonders if that stigma will "stick" in view of the increasing realization that such views were not heretical, but forward-thinking along the lines of my early medical mentor, the late Victor P. Satinsky, MD of Hahnemann Medical College and Hospital:

From http://www.upenn.edu/gazette/0298/0298obits.html: Dr. Victor P. Satinsky, C'34, Philadelphia, a cardiovascular surgeon at the old Hahnemann Hospital who helped develop coronary-bypass surgery; September 7 [1997]. He is also credited with 30 major medical innovations and the invention of the Satinsky clamp, now a standard instrument in cardiovascular surgery. He joined Hahnemann (now part of the Allegheny health system [as of 2010 now Drexel College of Medicine - ed.]) in 1946 to do thoracic-surgical research, and from 1961 till his retirement in 1977 he was the research director of its cardiovascular institute. Dr. Satinsky liked to refer to himself on promotional materials as 'the Renaissance Doctor', as he was also a poet, a playwright (some of his plays were produced in London), a painter, a clarinetist, and a fencer; he was known at Hahnemann for practicing his swordsmanship in the halls and classrooms of the hospital. And at the age of 80, he earned a black belt in aikido, and subsequently taught it. Although he had no religious training, during the Second World War he once filled in as a rabbi on a troopship going to Europe when he learned it had chaplains, but no rabbi. He also had taught himself psychiatry and while at Hahnemann developed educational programs for young people; the first, for gifted high-school students, began in 1961. He later added programs for disadvantaged youth, for young people with emotional problems, and one for college dropouts. On retiring, he set up the Satinsky Institute for Human Resource Development to continue this work, which he ran until his death at 84 years.

Dr. Satinsky's short, simple and unyielding credo was:

"Critical thinking always, or your patient's dead."

-- SS

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