Food Graphics and Fallacies ...

... (or is that phalluses?).   I about spit out my coffee when I clicked on a graphic from NuSI that Josh linked to in comments in another post.  (BTW, an aside, I try to keep the blogging up at the expense of responding to comments so I apologize for getting quite behind of late.)  So I decided to use my crudely constructed "arrows" at right in my graphics.  Yes, that's Rick Moranis from Space Balls there!

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Another unsolicited email from a physician describing EHR-caused chaos in the clinic

I periodically receive unsolicited stories of EHR difficulties (mayhem, really) as a result of clinicians or others locating my materials online, via web searches, social networking sites, or word of mouth.

Another unsolicited email from a physician describing EHR-caused chaos in the clinic, reposted with permission, is at my Health IT academic site at this link.

-- SS

At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professionals

I am revisiting the issue of HITECH in light of recent reports on health IT drawbacks and/or failure to achieve long-claimed advantages.

The HITECH Act, a multi-billion dollar EHR incentive/penalty measure inserted into the 2009 American Recovery and Reinvestment Act legislation (ARRA or 'economic recovery' act), is proving to be an example of what should be called "Social Policy Malpractice."

The HITECH Act was largely a consequence of intense industry lobbying on behalf of the IT industry (as in the Washington Post at "The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records", May 16, 2009).

It is in fact not based on science or reliable evidence, and has led to increased patient endangerment and a worsening national debt picture.

The recent revelations of reports from diverse sources including but not by any means limited to the following indicate that HITECH and its expenditures of billions of dollars on experimental, unregulated, unproven technology represents social policy malpractice:
 

• ABC News (Your Medical Records May Not Be Private: ABC News Investigation" - privacy of electronic health data is very poor, in ways that paper would and could never have permitted);

• The Center for Public Integrity "Growth of electronic medical records eases path to inflated bills", on how EHRs lead to increased, not decreased healthcare costs;

• Experts at Penn and Harvard -"A Major Glitch for Digitized Health-Care Records" - savings from EHRs are illusory;

• Budget reports - in view of the deficit spending reported by OMB and others that is causing national debt to spiral out of control, jeopardizing the economic well being of the United States, and with upcoding as a side-effect and no cost savings, HITECH is an unaffordable extravagance. 

• Recent revelations of outright EHR-induced mass chaos largely due to outspoken clinicians who've had enough - "Contra Costa County health doctors air complaints about county's new $45 million computer system", "Lake County (IL) Health Department - Depression era soup lines at the clinic";

• Abuses of NPRM Public Comment periods on followup health IT incentive regulations via industry ghostwriting (stealth lobbying), reducing EHR effectiveness while further enriching the industry - "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?";

Of course, I'd already cited these reports in past posts but they bear repeating:

• The IOM report on HIT safety ("There's risk, but we don't even know the magnitude because there are major systemic impediments to diffusion of that information"), http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html;

• FDA (known injuries and deaths are likely the "tip of the iceberg" because of the impediments, and EHRs are medical devices that should fall under the FD&C Act, but FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices because they're a political hot potato - Jeff Shuren MD JD, CDRH), http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html;

• NIST (health IT usability is poor, major remediation is needed) - http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html

I'd called for a moratorium on ambitious EHR plans for similar reasons as far back as 2008, at posts here and here.

 

The path that ethical medical centers and clinicians should take is to delay computerization in 2012 and push for slowdown or retraction of HITECH and its penalties for non-adopters. 

Yet instead, what is usually seen is excuses and cheerleading by healthcare organization leaders, and passive physician and nurse acceptance of deficient information technology.  

This stunning passivity and acceptance by physicians and nurses of a deeply flawed technology of unknown risk seems largely due to physician learned helplessness and the Stockholm Syndrome.  See the posts on "physician learned helplessness" at http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html (commenting on observations in MedScape written by a lawyer), as well as on the "Stckholm Syndrome"  at http://en.wikipedia.org/wiki/Stockholm_syndrome. 

Per a psychiatrist/informatics specialist Dr. Scott Monteith who has commented on this blog, the compliance of clinicians may also be a manifestation of the inherent human psychopathology reflected in the Milgram Experiment (and elsewhere):

The Milgram experiment on obedience to authority figures was a series of notable social psychology experiments conducted by Yale University psychologist Stanley Milgram, which measured the willingness of study participants to obey an authority figure who instructed them to perform acts that conflicted with their personal conscience. Milgram first described his research in 1963 in an article published in the Journal of Abnormal and Social Psychology, and later discussed his findings in greater depth in his 1974 book, Obedience to Authority: An Experimental View.

As to the consequences of physician "acceptance" of this technology in 2012 in its present condition, physicians are:

• Acting, in effect, 'in loco parentis' for their patients, not in the latter's best interests, who are not even afforded opportunity for informed consent.  This is in violation of long-accepted norms of human subjects experimentation and research such as the Belmont Report, Nuremberg Code and HHS human subject protection regulations at 45 CFR part 46 themselves;

• Giving free provision of their expertise and labor at improvisation and workarounds, in effect providing free alpha and beta testing to an entirely unregulated IT sector;

• Engaging in passive acceptance of the entire liability and their hospital executives' breach of fiduciary responsibility to protect them from same due to Hold Harmless clauses, and breach of Joint Commission safety standards through signing "gag" clauses on defects and harms (see http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda).

National health IT leaders have proven to be hyperenthusiasts about health IT benefits as well:

... This from Robert Kolodner, former head of the Office of the National Coordinator for Health IT (ONC) at HHS:

Dr. Robert Kolodner, a physician who headed the federal push for electronic medical records in 2007, acknowledged that billing abuse took a backseat to steps likely to entice the medical community to embrace the new technology.

Kolodner said officials were certain the savings achieved by computerizing medicine would be so great that billing abuse, “while needing to be monitored, was not something that should be put as the primary issue at that time.”

In other words, sideline (ignore) health IT-based billing abuse (and safety risks to the live patients subjected to this experimental technology without informed consent) because "we believe" the savings will be greater based on "our faith in the technology."

 

Such individuals contributed materially to the social policy malpractice represented by the HITECH ACT.

Considering all of the above, I call once again for a moratorium on further economic incentives for EHR adoption, and investment in the very measures recommended by the National Research Council in its Jan. 2009 report "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions" that:

In the long term, success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.

This research must be conducted, of course, with full human subjects protections in place.

-- SS

In addition to nurses, doctors now air their alarm: Contra Costa County health doctors air complaints about county's new $45 million computer system

At my Aug. 2012 post "Contra Costa's $45 million computer health care system endangering lives, nurses say", I described how an experimental EHR being forced on clinicians in Contra Costa county, California, was endangering patients who had not consented to its use, and how nurses were reported to be raising hell about it.  I also noted:

... The[se] scenarios [of EHR-created mayhem] are also usually accompanied by amoral misdirection from these personnel away from patient risks...

Herein is the problem:  the attitude that a clinic full of non-consenting patients is an appropriate testbed for alpha and beta clinical software that puts them at risk is medically unethical, based on the guidelines developed from medical abuses of the past.  There is nothing to argue or debate about this. 

Now the affected physicians have their say.

These physicians are apparently represented by a union; therefore they likely fear retaliation less than non-union physicians, and thus can be candid:

Contra Costa County health doctors air complaints about county's new $45 million computer system
By Matthias Gafni
Contra Costa Times
Posted:   09/18/2012, Updated:  09/19/2012

MARTINEZ -- One of every 10 emergency room patients at the county's public hospitals in September left without ever being seen by a doctor or nurse because of long waits -- a number rising since implementation of Contra Costa's $45 million computer system July 1.

One patient waited 40 hours to get a bed.

Dr. Brenda Reilly delivered the troubling news Tuesday afternoon to county supervisors. She was one of three dozen doctors in the supervisors' chamber complaining about EPIC, new computer software aimed at integrating all of the county's health departments to create a federally mandated electronic medical record for patients.

The response, as seen later, were characterized by the typical amoral excuses, mistaken beliefs in technological determinism, (a/k/a quasi-religious computer fanaticism) and misdirection I described above.

To allow for the major computer program installation and conversion, administrators cut doctors' patient loads in half, in turn cutting the number of available appointments in half.

In a letter to the supervisors, Dr. Ori Tzvieli -- medical staff president whose union has been negotiating a new contract with the county -- along with 14 doctor co-signers pleaded for administrators to continue scaling back physician workloads because doctors are over-stressed. Six doctors have left this year, said Dr. Keith White, a 22-year pediatrician.

I point out that such stress from interacting woth a mission hostile EHR (really, a clinician workflow-control system), and the needed state of hypervigilance to avoid IT-related mistakes that harm patients, lead to burnout and ultimately, a lower quality of patient care. 

Patient workloads were reduced by 50%, which is bad enough (and indicative of gross project mismanagement, as I wrote about in another example in my Sept. 2012 post "Lake County (IL) Health Department: The extremes to which faith-based informatics beliefs can drive healthcare facilities - Depression era soup lines at the clinic?").

Yet the 50% reduction, according to the principal end users, was still not enough.  Usability and fitness of the software is surely in question.

"We were not ready for EPIC and EPIC was not ready for us," White told supervisors. "As a result, the providers are struggling to provide safe and effective care for 100,000 citizens of the county, many of whom are very ill. We often feel that we are failing. We are very tired ... many doctors have left and all are considering leaving."

It is impossible for people, especially medical professionals, to be "ready" for a system that "is not ready for them", i.e., "bad IT" as defined at my teaching site intro at this link:

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, 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, 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, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

The two phrases "We were not ready for EPIC" and "EPIC was not ready for us" do not belong together in the same sentence.

A claim that physicians (and nurses) are "struggling" to provide safe let alone effective care for 100,000 should RAISE ALARM BELLS, not produce a paternalistic, patronizing response from medical and governmental officials as it did, seen below.

Both doctors and administrators agreed Tuesday that creating an integrated electronic health record is important, but a series of white coats stepped to the podium in what they jokingly termed "Doccupy" to share their nightmarish last few months.

I disagree with the assessment that "creating an integrated electronic health record is important", in that the technology and know-how to do so without endangering the very patients the technology is supposed to protect does not yet seem to exist in the commercial sector.

In that sense, regulating EHR technology and subjecting it to controlled clinical trials and refinement (as with any other medical device or drug, and many other types of healthcare-related IT such as MDDS - medical device data systems) with consenting subjects is what's important.

On MDDS, from the FDA link above:

Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS are not intended to be used for active patient monitoring. Examples of MDDS include:

• software that stores patient data such as blood pressure readings for review at a later time;
• software that converts digital data generated by a pulse oximeter into a format that can be printed; and
• software that displays a previously stored electrocardiogram for a particular patient.

The quality and continued reliable performance of MDDS are essential for the safety and effectiveness of health care delivery. Inadequate quality and design, unreliable performance, or incorrect functioning of MDDS can have a critical impact on public health.

That health IT used on live patients receives special regulatory accommodation in the form of non-regulation, when clearly the quality and continued reliable performance of EHR systems are essential for the safety and effectiveness of health care delivery, is inexcusable in 2012.  

(Of course, stunningly, FDA won't touch the latter, although admitting they are medical devices that should fall under the FD&C Act, because EHRs are a "political hot potato."  See this post for the relevant citations.)

... "This has been excruciatingly painful to do what is needed for those people who need it most," said Dr. Rachel Steinhart, an emergency room doctor who worked a graveyard shift ending Tuesday morning, hours before the board meeting. She said she still had to document paperwork for 16 of her patients. "It's going to implode. It can't go on like this."

Patients are surely going to be injured or killed in this setting.  There is likely a "hold harmless" clause with the vendor, so, doctors, I'm sorry to say, despite your complaints, you will very likely be held legally liable.

The head of the county's health care system sympathizes, and hopes to work with medical staff to ease the transition for what is a monumental moment in medical history.

"We're in an era of massive change right now, not only in our system, but in the system nationwide," said Dr. William Walker, Contra Costa's health services director. "Coming with the rapidity is its throwing people off balance."

Dr. Walker has just painted a big red "name me as a defendant for gross negligence and breach of fiduciary responsibilities to patients and clinicians" target on his back for glossing over known health IT risks and what appear to be rather profound complaints coming from his constituents.  Instead, he supplies platitudes, not action to remediate or withdraw the bad IT.

Name me as a defendant for gross negligence and breach of fiduciary responsibilities to patients and clinicians

The response is stunning:

To ease the burden, Walker hopes to have teams of medical care providers formed to ease the doctors' paperwork burden, enabling them to return to treating patients.

It takes teams of physicians to properly see a patient due to the interference of EHRs?  That is remarkable.

The ccLink program has its benefits, some doctors said. Dr. Chris Farnitano, an ambulatory care medical director, described how he retrieved a patient's biopsy results from a different hospital on the spot, whereas in the past it would have taken weeks.

However, other doctors called ccLink clunky and time-consuming, designed more for bureaucrats than physicians. Even with doctors cutting their patient load in half -- meaning half as many appointments are available for patients -- doctors complained that they spend more time on their computers than treating patients.

This is misdirection by the Medical Director.  It's unarguable that the risks far outweigh the benefits.  Further, retrieving a biopsy or other result result instantaneously could easily be done from an innocuous, non-disruptive document imaging system (e.g., Documentum).  The latter would also be many millions of dollars less expensive than an EHR.

"It's a truncation of patient care. The individual patient doesn't get the care they used to get," said David MacDonald, a 22-year family medicine doctor.

Again, Dr. MacDonald, the liability for adverse outcomes is on you.

You are now, in effectm an indentured servant of an IT company, providing free alpha and beta testing at your expense and peril, using the patients as an even lower level of indentured servant/guinea pig.

There's also significant patient-endangering collateral damage from this mayhem:

The lack of appointments has overburdened emergency rooms, which already exceeded emergency room wait benchmarks in a facility built to see 80 patients a day, but often sees more than 200 patients a day. Since ccLink started, the average patient spends four hours in the ER, up an hour from before the computer system transition, which was already over national benchmarks, said Reilly.

The scenario could not be worse.  The ED's are themselves burdened by EHR's.

The supervisors asked for continued updates, and for patience.

"Continuous improvement means you need continuous change," said supervisor Federal Glover. "Eventually, it's going to become second nature as it was with cell phones. We'll wonder how we ever did without it."

Supervisor Glover has also painted a "defendant" target on his back.  This is the misdirection I was speaking of earlier, consisting of platitudes, logical fallacy and falsehoods:

• "Continuous improvement" is not what's going on here; 
• Such improvement does not mean creating chaos as a precondition; 
• Whether this software will become "second nature" is anyone's guess.  That is a hysterical and logically fallacious statement (e.g., an appeal to belief) of an almost quasi-religious fanaticism regarding computing.  This technology could ultimately be scrapped in favor of, say, simpler document imaging systems due to increasing clinician complaints, inherent usability issues in fast-paced medical settings, litigation, costs, harms etc.;
• What of the patients placed at risk, and/or injured/killed as a result of this experimentation?  What of them, and their medical and human rights?

In effect, a response like this is medically unethical.  The correct response would be a halt in the rollout until problems are substantially remediated in a controlled, risk free setting - not the clinic.

If that is not possible, the system needs to indeed be scrapped or replaced.

Continuation of patient endangerment is inexcusable medically, ethically and legally.

-- SS