Why non-medical amateurs need to be kept away from authority roles in health IT ... lest their ignorance kill people

This example of a disaster waiting to happen, in the form of an error-promoting CPOE, is a poster example of why the net of litigation needs to be cast far wider than just clinicians when EHR-related errors result in injury or death:

CPOE selection screen for crucial blood thinner, coumadin (Warfarin).  Click to enlarge.

This order entry screen, from a production system (of a vendor whose stock price has recently taken a dive) shows the following.  In all fairness, I do note it's unclear if the vendor or the customer's configuration "experts" were responsible for this:

COUMADIN (warfarin) tablet 2 mg Oral daily once.
CAUTION: Potential look-Alike or Sound-Alike medication - this product is COUMADIN

with similar entries for other doses.

Below and not indented as is the selection, where the clinician is liable not to look very carefully, is the helpful interpretation:  "warfarin (COUMADIN) Tablet 2 milligram Oral daily for 1 Times."

"Oral daily for 1 Times?"

This drug needs to be given daily, generally for a very long term.  Its effect on blood clotting varies for numerous reasons in an individual over time, and needs to be checked frequently via a blood test (International Normalized Ratio or INR) to ensure the level of effect is neither too little (which could result in clots) or too much (which could result in serious or fatal bleeding).

In this case, the clinician wanted Coumadin to be administered "daily", as in "each and every day", but this was the default - daily, but only once.  "Oral daily for 1 Times."

Brilliant!  

Daily Coumadin (i.e., daily EVERY DAY), the clinician related, could be ordered only with "painstaking difficulty."

"X mg Oral daily once" is an unimaginably absurd and bizarre dosing selection to have on a CPOE system for such a critical drug - or any drug.  "Daily - once?"  

It should not, and does not, take a rocket scientist to realize this selection could quite easily lull the busy clinician into believing they have selected a dose to be continued every day - i.e., "once daily" - as per the standard usage of this drug.

To order this drug for (true) daily administration, a user must find a "repeat" icon and click the number of days the drug is to be administered.  The "repeat" icon is not readily apparent amidst screen clutter.

For other drugs, the order choices are "## mg oral daily" or similar. 

This semantic and human-computer interaction ineptitude is truly a disaster waiting to happen, especially with the medical/nursing/trainee staff turnaround that goes on in hospitals, and with the reality that clinicians are working at various hospitals with different CPOE/EHR systems.

Is this some sort scheme to prevent endless-administration Coumadin errors when the drug is actually deliberately discontinued, I ask?  If so, it's ill-conceived and dangerous at best.

By way of further information, this drug is a common anticoagulant whose use is often protective of injurious or fatal blood clots that can cause strokes or death in people with common conditions such as atrial fibrillation or prosthetic heart valves:

Warfarin is used to decrease the tendency for thrombosis or as secondary prophylaxis (prevention of further episodes) in those individuals that have already formed a blood clot (thrombus). Warfarin treatment can help prevent formation of future blood clots and help reduce the risk of embolism (migration of a thrombus to a spot where it blocks blood supply to a vital organ).

The type of anticoagulation (clot formation inhibition) for which warfarin is best suited, is that in areas of slowly-running blood, such as in veins and the pooled blood behind artificial and natural valves, and pooled in dysfunctional cardiac atria. Thus, common clinical indications for warfarin use are atrial fibrillation, the presence of artificial heart valves, deep venous thrombosis, and pulmonary embolism (where the embolized clots first form in veins).

This is an example of the kinds of mission hostility (other equally bizarre examples presented here) that results when amateurs attempt to play doctor.

I add that this type of "errorgenicity" is inexcusable.  If patients suffer harm from this type of "feature", the net of liability needs to go further than just the clinician who was caught in a web of cybernetic clinical toxicity.

-- SS

5/1/2012 Addendum:

More EHR madness and another physician, a cardiologist and electrophysiologist, who also believes these should be considered medical devices.

From DrWes blog (excerpts, and emphases mine; see entire post at link below):

The Electronic Medical Record Should be Viewed as a Medical Device 
Apr. 30, 2012

This week I received a medical record from a large academic medical center somewhere in the United States (the details were are unimportant) that has one of these new pioneering EMR systems manufactured by $13 billion-dollar company, Cerner Corporation ... what I saw was one of the better examples of how EMRs are contributing to misinformation and confusion when health care is delivered.

I received a copy of an internal medicine consult that was performed on a patient at this outside hospital. I have extracted the "medications" portion of the internist's note exactly as it was displayed in the note below ... Needless to say, I was terrified at what the system had listed as the patient's medications:

In this example, we see multitudes of medications listed more than once. We see drugs of similar classes (antihistamines, beta blockers) on the same list. We see warfarin, one of our most dangerous drugs dispensed, without a dose included. We see what seems to be outpatient meds listed with inpatient meds, I'm not sure. Honestly, we really have no idea what medications are actually being taken from this list. And yet this list of medications is listed by the EMR as the patient's "Active Medications."

Med list (page 1).  Click to enlarge; see original post for part 2.


... What the heck have we created? 

Certainly, any capable physician who cares for patients would describe this medication list as worthless.

This "med list" is similar to the list I showed at part 4 of my multi-part series on the mission hostile user experience of most commercial EHR's, from yet another system, redrawn by me in redacting the vendor ID.  These lists reflect a mercantile computing person's view of a med list as an inventory of pills:

 Another "what the heck have we created?" EHR med list, on screen. Click to enlarge.

 Dr. Wes also asks:

... So how will we measure problems with EMRs? It seems industry representatives would rather not address these concerns. We should ask ourselves, is anyone thinking about this?

Yes, they are.  And we are spreading our thinking to one place where action might actually occur sooner rather than later:  to the Plaintiff's Bar.

-- SS

Using a "Professionalism" Initiative as a Speech Code to Punish Students' Criticisms of Administrative Authority?

The original impetus to set up Health Care Renewal was increasing evidence of external threats to physicians' professional values.  So it seemed to me that renewed interest in addressing professionalism in academic medicine might lead to more attention to these threats, and perhaps even real challenges to them. 

Instead, most academic professionalism initiatives seem to have steered away from this contentious area.  Worse, at times the academic medical concept of professionalism has been turned on its head. 

A Dispute Among Students at University of California - Davis

A recent post in the Torch blog from our friends at FIRE (the Foundation for Individual Rights in Education) provided a graphic example.  The case involved an apparently trivial dispute among two medical students:

[University of California - Davis medical student Curtis] Allumbaugh's ordeal began after he emailed the 'med2014' mailing list (or 'listserv') on July 19, 2010, regarding a party he was organizing. The listserv was widely used for a variety of non-academic purposes. Allumbaugh's email provided the address of the party, detailed the available space, and listed the variety of alcohol that would be available at the party. The email noted that others had signed up to bring snacks and mentioned that some things were still lacking for the party, such as music, fruit juice, and beer. Prior to Allumbaugh's message, others had sent similar emails using the same listserv about their own parties, such as a 'kegger' one student called 'CAMP MED.'

On July 20, 2010, a second-year student emailed Allumbaugh, notifying him that she had 'been placed on the class of 2014's listserve' and had monitored the class email. She criticized Allumbaugh's email for placing 'a heavy emphasis on alcohol.' In response, Allumbaugh emailed her directly on July 21, calling her a 'busy body' and telling her, 'You should really just mind your own business and let our class be.'

Note that the second-year student's email (available here) carried a suggestion that she had some sort of authority to monitor the extra-curricular actions of first year students as manifested on the list server, and perhaps even punish them for perceived misconduct:

I can tell you that as MS2s, we work and play hard, but we do it responsibly and always in the forefront of our minds we remember what image we are portraying in public and through the messages we send. I'd hate to see any one of you 2014ers get into any trouble right before you start an amazing period of your life.

Note that the exchange between the two students did not occur in an academic or clinical setting, and it was never clear why the second year student was "placed on" the list server, or why she should have any authority over the Allumbaugh. .

The School Administration Invokes "Professionalism"

The medical school saw fit to cast Allumbaugh's actions as violations of the school's standards of professionalism:

As a result of this email exchange, Associate Dean of Student Affairs and Graduate Medical Education James Nuovo sent Allumbaugh a letter on September 14, 2010, citing him for 'failing to demonstrate the highest standards of civility and decency to all' and 'failing to demonstrate courtesy, sensitivity and respect.' On November 3, 2010, Allumbaugh received a letter from the SOM Committee on Student Progress, punishing him with academic probation for the rest of his time in medical school and requiring him to undergo a psychological assessment to determine whether he was 'fit' to continue in medical school.

Finally, on November 19, 2010, SOM changed its rules to force all medical students to abide by the Principles of Community or else face academic probation.

The result was a series of interventions by FIRE:

In response, FIRE wrote UC Davis Chancellor Linda P.B. Katehi on August 3, 2011, noting that enforcing professional standards in truly professional settings differs greatly from enforcing workplace standards in other settings such as private conversations. FIRE also noted that it is blatantly unconstitutional to police student speech under the UC Davis Principles of Community because such a 'civility' policy violates the First Amendment right to freedom of speech when it is given disciplinary force.

When that letter had no effect, it took threats of litigation for the medical school to suspend Allumbaugh's punishment more than one year after it began:

SOM Associate Dean of Curriculum and Competency Development Mark Servis replied to FIRE on August 10, 2011, defending the policy. FIRE responded on November 23, 2011, reminding Katehi that 'violating well-established law regarding the First Amendment rights of students at public universities leaves you at risk of losing qualified immunity, thereby opening you and other administrators to personal liability' for the deprivation of students' First Amendment rights. Servis again defended the policy in a reply on December 5, 2011.

Finally, on February 16, 2012, the Committee on Student Progress notified Allumbaugh that his probation had been dropped, but persisted in requiring him to adhere to the Principles of Community.

Note that Associate Dean Servis' letter stated that the email sent to Allumbaugh by the second year student was "a genuine suggestion of concern and an offer of albeit unsolicited friendly advice."  Thus, Servis seemed unaware that it could have been interpreted as an assertion of authority and a threat of punishment ("I'd hate to see any one of you 2014ers get into any trouble.")

Dean Servis also defended the use of probation to punish a student for failing to "work effectively with classmates." Yet the dispute that had nothing to do with (academic or clinical) work, and only involved a single student from another class.  Why that student was not equally to blame was not clear, unless it was because she had been granted special authority by the administration to monitor the actions of less senior students.  The implication appears to be that the punishment was in defense of a student who had been granted special authority by the administration, and hence was ultimately in defense of the administration's power. 

Summary

In this case, the medical school's professionalism policy seemed to be used by the administration primarily to control students' speech outside of the academic and clinical setting. Furthermore, the student's main offense seemed to be failure to kowtow sufficiently to another student who by implication had been given some sort of authority by the administration.  What the two students' dispute had to with professionalism is not  apparent.

On one hand, this seems like a case in which a speech code was mainly used to defend administrators from criticism and challenge.

On the other hand, this speech code was cloaked in the mantle of professionalism.  So this case seems to be an example of a professionalism initiative used as an excuse for the leadership to maintain its power.

It is beyond ironic that while this was going on, the University of California - Davis, and its Chancellor Linda Katehi were becoming briefly infamous for another effort, a more violent one, by the administration to prevent criticism and challenge. Chancellor Katehi had authorized university police to "clear" student demonstrators from an "occupation" of the campus which was protesting, among other things, rising tuition and economic inequality, and in doing so, the police used pepper spray on unarmed students (see this post.)

There are a lot bigger threats to physicians' and other health care professionals' professionalism than medical students' sarcasm or even rudeness in disputes about alcohol served at off-hours parties. Since many of these threats also generate personal benefits to academic leadership, it may not be much of a surprise that they have received little attention.  (See the list of threats appended below.  Note that we have discussed two of these threats in the specific context of the University of California - Davis.  Here we noted that Chancellor Katehi seemed to be re-imagining her medical school as a biotechnology company.  Here we noted that Chancellor Katehi was also on the board of a company with a medical education and communication company subsidiary.)

However, while they remain unaddressed, I submit that using "professionalism" to cloak increased social control of students to prevent them from looking too closely at what academic administrators are doing will eventually backfire. 

===
ADDENDUM: List of Threats to Professionalism


Instead, to really uphold professionalism, we need to defend it from its real threats, as listed in my 2010 post:

• Abandonment of traditional prohibitions of the commercial practice of medicine - In the US, a Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition.  The result was increasing, now rampant commercialization.  See posts  here and here.
• Making money takes precedence over education -  A recent survey showing that more than half the faculty at multiple US medical schools felt they were valued more for how much money they brought in than their teaching or patient care abilities (here), confirming previous anecdotal reports (see here). 
• The medical school re-imagined as a biotechnology company -  In 2000, a Vice President of the American Association of Medical Colleges(1) wrote that research universities must respond to "societal demands that they become engines of economic development…."  Many universities now defend lax conflict of interest policies with similar arguments.  For more details, go here.
• Faculty become employees of industry - For numerous examples of this and other kinds of conflicts of interest, go here.  A survey by Campbell et al suggested that approximately two-thirds of medical academics get significant payments from industry.(2)
• Academics become "key opinion leaders" paid to market drugs and devices - Marketers regard "key opinion leaders" as salespeople who appear more credible because of their professional guise.  See anecdotal evidence here.  
• Control of clinical research given to commercial sponsors - A study by Mello et al showed how universities' grant administrators are willing to sign contracts giving commercial sponsors control over key aspects of human research studies.(3)  See post here. 
• Conflicts of interest allow manipulation and suppression of clinical research - Commercially sponsored research design, implementation, and dissemination are often manipulated to favor the sponsor's interests.  When such manipulation fails to produce favorable results, the results may simply be suppressed.
• Academics take credit for articles written by commercially paid ghost-writers - Such ghost-writing is often part of organized stealth marketing campaigns. 
• Whistle blowers are discouraged, or worse, and academic freedom is damaged.  Discussion of some examples of what may happen to whistle blowers is here.  The survey mentioned earlier (here) showed that about one-third of faculty fear they may be punished for speaking  out. 
• Leadership of academic medical centers by businesspeople - Ill-informed management may result from leaders who have no background or training in actual health care. 
• Leaders of teaching hospitals and universities become millionaires -  A recent example is here, and more may be found here.  Leaders of academic medical centers and the parent universities of medical schools often make more than $1 million a year in the US.  When such amounts are in play, executives may focus more on short-term measures that lead to even more pay than on upholding the mission. 
• Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations - A recent example is here, and a summary of how we discovered this phenomenon in 2006 is here.   The conflict of interest is severe because directors of for-profit corporations are supposed to have unyielding loyalty to the interests of the corporation and its stockholders, although they are frequently accused of acting mainly as cronies of the top hired executives (see here and here).
• Leaders of failed finance firms become stewards of academic medicine - We have found numerous examples, recently here, here, and here, of top executives and/or board members of the finance firms who helped bring on the global financial collapse also being trustees of medical schools, academic medical centers, or their parent universities.  Such "stewards" may bring to the academic environment the "greed is good" culture now pervasive in finance. 

References


1. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. Link here.
2. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Llink here.
3. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.  Link here.

KevinMD: How algorithm driven medicine can affect (make more dangerous, actually) patient care

Reposted from KevinMD blog on another aspect of the health IT mission hostile user experience. Emphases and comments in [red italics] are mine:

How algorithm driven medicine can affect patient care
by Jeffrey Parks, MD

Whenever someone is scheduled for an operation, the assigned nurse is required to fill out a “pre-op checklist” to ensure that all safety and quality metrics are being adhered to. Before the patient is allowed to be wheeled into the OR we make sure the surgical site is marked, the consents are signed, all necessary equipment is available, etc. One of the most important metrics involves the peri-operative administration of IV antibiotics. SCIP guidelines mandate that the prophylactic antibiotic is given within an hour of incision time to optimize outcomes. This has been drilled into the heads of physicians, health care providers, and ancillary staff to such an extent that it occasionally causes total brain shutdown.

Let me explain. For most elective surgeries I give a single dose of antibiotics just before I cut. For elective colon surgery, the antibiotics are continued for 24 hours post-op. This is accepted standard of care. You don’t want to give antibiotics inappropriately or continue them indefinitely.

But what about a patient with gangrenous cholecystitis or acute appendicitis? What if, in my clinical judgment, I want to start the patient on antibiotics right away (i.e. several hours before anticipated incision time) and then continue them for greater than 24 hours post-op, depending on what the clinical status warrants? I should be able to do that right? [No - wrong - the idiots who designed your CPOE/Pharmacy IT system forgot that robotic medicine is bad medicine - ed.]

Well, you’d be surprised. [No, actually, I'm not. I'd have been more surprised to see a system not impeding critical medical decisions tailored to the individual patient - ed.]

You see, at two different, unaffiliated hospitals I cover, the surgeons have seen that decision-making capability removed from their power. If a young patient comes in with acute appendicitis and I feel that it would be prudent to continue the Zosyn an extra couple of days, an automatic stop order is triggered [presumably cybernetically - ed.] in the department of pharmacy and the antibiotic is stopped after 24 hours, no matter what. Unless the surgeon specifically writes “please do not stop this antibiotic after 24 hours; it is being administered for therapeutic purposes, not prophylaxis [that sounds a bit like begging - ed.] ,” the antibiotic will not be sent to the patient’s floor for administration. As a result, patients end up being treated sub-optimally, and potentially harmed, due to an over-emphasis on “protocol” and “quality care metrics.”

Similarly, the 60-minute timeline for pre-operative antibiotic administration can be problematic. I have had patients come into the ER with appendicitis or cholecystitis and, in my pre-op orders, write for Zosyn or whatever, to be started ASAP, no matter what time the operation is scheduled. Not too long ago, I admitted a gallbladder over the phone at 2am. I gave the nurse admitting orders which included one for a broad spectrum antibiotic.

When I saw the patient in the morning, I added her on to the OR schedule. By the time a room opened up, it was about 10:30am. The OR nurse asked me if I wanted to give an antibiotic for the case. I told her that the patient was already on antibiotics as part of her admit orders for treatment. The nurse shook her hand. It had never been given; the floor nurse held it so that it wasn’t administered until 60 minutes before the scheduled OR time, just like the algorithm dictates — despite the fact it had been ordered nearly 8 hours prior to the case, not for peri-op prophylaxis, but for treatment of an established pathology. [This is how EHR-induced malpractice occurs, readers. Guess who bears liability? - ed.]

And there it was, the cefotetan, hanging on her IV stand. Now nothing bad happened [this time, due to luck - ed.], but here you have a situation where health care providers are so terrified of violating Quality Assurance Protocol that they end up withholding necessary treatment. It’s just astounding. [It's astounding the surgeons don't simply use a scalpel on the computer terminal network and power cables to protect their patients - ed.]

As surgeons, we have bitched and moaned. You would think that these issues would be quickly rectified. But no. It is the responsibility of the surgeon to write qualifying statements [a workaround to a 'feature' that turns medical judgment on its head - ed.] for therapeutic antibiotics because the default mode is to override a licensed physician’s clinical judgment. [Not mentioned is who is overriding that judgment through cybernetic proxy - ed.]

This is what I’m talking about when I say that blind allegiance to a top-down, systems analysis-driven algorithm can turn everyone involved in health care into a bunch of mindless drones.

Jeffrey Parks is a general surgeon who blogs at Buckeye Surgeon.

I will simply add that these issues sound like poor IT/protocol design and implementation, getting in a physician's way regarding tailoring of care to the individual patient.

An inviolable rule in health IT is - or needs to be -

"You should not have to work around something that is not in the way."

There is nothing to debate or discuss on this issue.

-- SS

Feb. 3, 2012 addendum:

Some IT person (anonymously, of course) tried to argue and debate anyway; however, they did not even do basic homework. See their comments in the comments box.

Feb. 5, 2012 addendum:

More in the comments section by someone saying they made the aforementioned comments, stating they are a hospitalist, and still trying to advance the same arguments in favor of physicians adapting to mission-hostile HIT and/or protocols rather than 'protesting too much.'

The EHR Mission Hostile User Experience, Part 10: Cerner Powerchart - via FDA's MAUDE Database

"You should not have to work around something that is not in the way" - SS
Some time ago, I'd written an eight part (later expanded to nine part) series on health IT mission hostile user interfaces and experiences.

(Note: Part 1 of this series is here, part 2 is here, part 3 is here, part 4 is here, part 5 is here, part 6 is here, part 7 is here, and part 8 is here. 2011 addendums: a post that can be considered part 9 is here, part 10 is here.)

Here is an addendum, part 10, from the FDA Maude (Manufacturer and User Facility Device Experience) Database. I do not know who wrote it or where it was from. It was received by FDA as indicated on 3 April 2011:

FDA MAUDE REPORT

CERNER POWERCHART

Event Type Other

Event Description

I am writing to report a problem in the design of the cerner powerchart computer provider order entry (cpoe) product. As i will describe below, these design flaws are largely responsible for approximately 100 medication errors per day in our 240 bed hosp. The (b)(6) hosp in (b)(6) is a 240 bed teaching hosp. We are owned by the (b)(6). We have to be one of the only hospitals in the country to fully implement cpoe with two entirely different electronic medical records (emr).

In 2007, we completed a comprehensive cpoe implementation using idx 3. 1 (which was later purchased by general electric). Our self-reported medication error rate was <2 error reports per day. In (b)(6) of 2010, we transitioned our emr to cerner millennium - powerchart (b)(4). This implementation was done as a first step to converge onto a single electronic medical record across the (b)(6) enterprise.

Despite extensive nursing informatics support (approx. 7000 hrs per month for the first six months after implementation), our error rate went from approx. 176 medication errors per day one month after implementation to approx. 100 medication errors per day currently. It has been stable at this level for at least the past 3 months. Many of these errors involve high risk medications (e. G. Heparin, morphine). In order to understand the etiology of the errors, i need to explain how cerner processes cpoe orders.

With cerner, orders are grouped into plans ("powerplans"). These plans can include sub-plans ("phases") and sub-sub-plans ("sub phases"). A typical orders display screen appears as follows: (b)(4). Under the plans is an order tab which displays other orders.

This design allows two distinct sources of error.

First, there is no consistent way to view orders for medications. A medication order can display either in a plan, sub-plan, or under the orders tab. In order to find a given medication, cerner mandates that you click through each and every plan. This facilitates duplication of both medication and non-medication orders (there is a medication checker which is so poorly designed and does little to aid the pharmacists in detecting duplicate medications).

Second and more dangerous, high risk intravenous medications can be run either inside or outside of the plan. Cerner programming [i.e., the user interface design -ed.] does not keep high risk medications in a consistent spot. It is very easy to stop monitoring for heparin (which is included in the heparin plan) while continuing the heparin (which is outside the plan) or vice-versa.

As you can probably guess, we formed multiple interdisciplinary teams to address these deficiencies. [Workarounds - ed.]

I was the lead physician on the orders team. Although we were unable to reduce the error rate, it is not close to an acceptable level. Again, i believe this is because of the design of the cerner product which is why i chose to bring this to your attention. With issues this complex, i am a firm believer that "seeing is believing. " if desired, i would be happy to arrange a web conference to demonstrate my concerns.

Brand Name CERNER POWERCHART COMPUTER
Type of Device NONE
Manufacturer (Section F) CERNER
Manufacturer (Section D) CERNER
Device Event Key 2081342
MDR Report Key 2045867
Event Key 1942844
Report NumberMW5020161
Device Sequence Number 1
Product Code LNX
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 04/03/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?
Page Last Updated: 11/30/2011

I will let the FDA report speak for itself, with only one question:

When will the designers, developers, purchasers and implementers of medical devices like this start to be held criminally liable for patient injuries that occur from the risk these devices pose to patient safety?

criminal negligence - (law) recklessly acting without reasonable caution and putting another person at risk of injury or death (or failing to do something with the same consequences)

It's not as if the issues related to good user interface design are a mystery, nor have those issues been a mystery for at least a few decades.

An EHR design as described, if accurate, while perhaps "nifty" in some way from the computer-techie perspective, would require significant recklessness to design and to actually implement in a life-critical setting.

Those who try to point out these issues internally are sometimes subject to retaliation (for not being a "team player", of course, which in today's parlance means someone who is silent, or silenced, or a co-conspirator regarding managerial mediocrity, malfeasance, or madness). An example is here. We at Healthcare Renewal simply refuse membership on that team.

(Did I mention this deterministic miracle-making technology is slated via the HITECH Act for rollout in the U.S., unless the medical professional or organization is willing to accept progressive cuts to their Medicare reimbursement?)

-- SS

The Ultimate Workaround To Mission Hostile Health IT: Humans (a.k.a. "Scribes")

"Gentlemen, we can rebuild him. We have the technology. We have the capability to build the world's first bionic doctor. Dr. Data will be that doctor; better worse than he was before. Better, stronger, faster Worse, weaker, slower." -- parody of Oscar Goldman from the 1970's scifi series The Six Million Dollar Man.

"Gentlemen, we can rebuild him."

The EMR is a technology that was supposed to improve clinical medicine (revolutionize it, some say). It was supposed to facilitate clinical medicine. It was not supposed to slow physicians and others down to the point of impairing their ability to practice medicine.

However, the rosy predictions are not proving to be the case. Instead, we have the ultimate workaround to the health IT mission hostile user experience:

Los Angeles Times
September 6, 2010

Harris Meyer

Scribes are doctors' tech support

Melissa Genove has dreamed of becoming a physician since childhood. To help her prepare, she spends as many as 35 hours each week shadowing emergency room doctors at Loma Linda University Medical Center. The 23-year-old listens intently as they examine patients, records their treatment plans in a laptop computer, and follows up on prescriptions, lab tests, consultations with specialists and anything else the doctors order.

Genove is not an intern, or even a medical student. She is the chief medical scribe in the hospital's emergency department — and one of several thousand young people pioneering a new healthcare field.

Scribes are filling a necessary niche as doctors make the wrenching transition from old-fashioned paper charts to 21st century electronic medical records. The computerized system is supposed to make doctors more efficient and ensure better care for patients. Congress has such faith in the value of electronic medical records that it provided as much as $27 billion over 10 years to encourage doctors to use them, and the Centers for Medicare and Medicaid Services will penalize those who don't by cutting their reimbursement rates as much as 5%.

But while the conversion is underway, doctors estimate that their productivity plummets by about 30% as they learn to cope with a complicated new system. [And what clinical IT in 2010 isn't complicated, I ask? - ed.] That's where scribes come in.

This brings real meaning to the observation that "you should not have to work around something that is not in the way."

Just one screen from a Cerner product (from a presentation touting recent addition of a simple database "search" feature that should/could have been present eons ago). Each menu item leads to even more screens, subscreens, menus and pick lists, in labyrinthine fashion. Click to enlarge.

In a domain as complex as medicine, ever-increasing demands for fine grained data on clinical encounters now outstrip the 2010-style human-computer interface's abilities to allow capture of the data without massive interference in the process of medicine itself.

This mismatch is due largely to the limitations of the GUI as the primary user interface (UI) metaphor, especially the widget-centric UI currently in vogue, characterized by massive numbers of screens and GUI widgets, labyrinthine navigation, and forced data entry of artificially and needlessly "atomized" data through interaction with multiple widgets.

CPOE as an example has become a Rube Goldberg contraption (def: "deliberately over-engineered machine that performs a very simple task in a very complex fashion"), the furthest thing from a straightforward "typewriter for orders" as can be.

For instance, a simple order requires interaction with search boxes, multiple drop down lists, scroll bars, check boxes, and other widgets to capture each micro-component of the order, wasting much time compared to writing "Sotalol hydrochloride 120 mg PO BID, first dose now." There are alternatives to "data atomization" and "widget-centricity" in the health IT user interface, apart from simply cleaning up the current interaction disorganization and other weaknesses, but the health IT industry seems largely oblivious to alternatives.

Professor Butts and the Self-Operating Napkin: EMR's have become machines that perform simple tasks in a very complex fashion

Unfortunately, it's difficult to show this complexity using actual EMR images, as most health IT vendors avoid posting screen images and user manuals online, and forbid customers from doing so. They are excessively secretive about their products. Try a Google image search on 'Cerner Millenium' as an example (click here), then compare to an image search on, say, Microsoft Word (click here).

The inappropriate-for-medicine, management information systems (MIS)-derived business model of the healthcare IT vendors and HIT ecosystem also contributes to the, at best, stuck-in-the-1980's health IT user interface. (As an example of these issues, the industry wouldn't even listen to aforementioned UI alternatives even if I served them up on a silver platter, because using the advice would require significant investments on their part to incorporate alternative UI approaches into their products, meaning lower short and medium term profits. Unlike pharma and tangible medical devices, interest in advanced R&D in the health IT industry seems nil. Instead, complacency rules.)

An important question to ponder is whether the dream of the health IT pioneers back in the 1950's and 1960's was too idealistic and indeed unrealistic to begin with. Was it based on "2001, A Space Odyssey"-style overoptimism, and the lack of foreknowledge of how little true progress would be made in the commercial IT market in human computer interaction, artificial intelligence, natural language processing, voice recognition, and other innovations by the 21st century?

Doctors have embraced the scribes as well. "The physicians were spending too much time documenting and not enough time with the patient," said Dr. Robert Steele, chief of Loma Linda's emergency department, which began using scribes in November. "The solution was to take the doctors off the computer, put them at the bedside, and let the scribe do the transcription. It's been a huge success. The physicians love it.

It is not hard to understand why physicians, with their years of training and expertise, would welcome relief from extremely tedious clerical tasks.

Leaders of the three biggest companies providing scribes estimate that about 200 emergency departments in community hospitals and academic medical centers currently use them. More scribes are on the way. Ronald Reagan UCLA Medical Center, Emory University Hospital in Atlanta and Beth Israel Medical Center in New York City said they are exploring the idea. Physicians in other specialties, including urology and family practice, also are starting to adopt scribes.

Still, some physicians question whether college students are equipped to handle the complicated task of charting patients after only two to four months of training. Others wonder why it's necessary to hire additional staff to fill out computerized records that were supposed to be simpler and more efficient than paper.

The key phrase is "were supposed to be simpler and more efficient" than paper. I'd likely be hard-pressed to find robust research supporting that assertion in the scientific literature. I'd be more likely find the origins of this meme in vendor marketing materials.

"It will be interesting to watch whether the need for scribes goes away as the next generation of physicians who grew up with computers and electronic medical records comes in," said Dr. Ann O'Malley, a senior researcher at the Center for Studying Health System Change in Washington, D.C.

This passage implies the bottleneck is those physicians who need to "get used to the IT", whereas a major component of the problem is the health IT user interface itself. Scribes might "go away" if the health IT user experience was vastly improved. The IT needs to become more physician and medicine-friendly.

At Loma Linda [Hospital], Steele said doctors used to spend two minutes with a patient, then take four minutes typing the information into a computer. Now the doctor talks to the patient with the scribe present and summarizes the encounter to the scribe in 30 seconds. While the scribe spends three minutes entering the information into an ever-present laptop, the doctor can spend extra time with the patient.

Afterward, the doctor checks the accuracy of the scribe's chart, makes any necessary additions or corrections, and signs off. Although novice scribes sometimes need the doctor's help in understanding terminology, those with several months' experience usually are spot-on, Steele said.

Again, clerical work is a very poor use of a physician's time. Scribes are a good idea considering 2010's EMR technology, at least from the time/skills perspective.

... [Dr. Michael] Murphy of ScribeAmerica estimates that doctors can see eight additional patients over a 10-hour shift, hiking Medicare revenues alone by $91 an hour.

The companies that develop and sell electronic medical records systems are "in total denial" about how complicated they are for doctors to use, [Dr. David] Strumpf said. "They know these systems need scribes," he said. "They work with us to train our scribes on their systems, but they don't want to be public about it."

(One wonders how much in "denial" the companies are and just who is truly in denial; after all, purchase of these systems just became a governmental priority.)

Here, of course, is the major drawback to scribes: money. Scribes "typically cost $20 to $26 an hour" today, and that number is likely to rise. While the article's contributors maintain that physicians can boost their revenues by "$50 to $60 an hour" using scribes, I wonder if the overall economic impact of the generalized use of tens or hundreds of thousands of EMR scribes would be in the "wrong" direction (i.e., from the payor and government perspective). The billions spent on EMR's were supposed to reduce the costs of healthcare, not increase the expenses associated with it.

I also wonder what could happen when a scribe is not available.

At the University of Virginia Medical Center in Charlottesville, Va., emergency room physicians can complete electronic charts just as fast as scribes, most of whom are pre-med students at UVA. But doctors would rebel if the scribes disappeared, said Dr. Robert Reiser, medical director of the scribe program, which the university runs itself.

Sept. 10 Addendum:

See an interesting financial analysis by Doug Perednia here.

-- SS

FDA MAUDE Database: Patient Outcome - Death

I present another health IT problem case from the FDA's voluntary MAUDE (Manufacturer and User Facility Device Experience) database below.

From FDA's description of MAUDE:

• MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.
• The on-line search allows you to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated monthly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.
• MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.

I somehow missed the following case when I wrote the Oct. 2009 post 'Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault' but I have added it there as well:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460
CERNER MILLENIUM POWERCHART CPOE
Event Date 11/19/2006
Event Type: Death
Patient Outcome: Death

The medication review screen of the subject device does not specify the exact dose in milligrams of combination medications. For example, narcotics are combined with tylenol in at least two strengths. Liquid narcotic tylenol-oxycodone combination is reported in ml, not mg. The exact dose of tylenol is not specified and requires knowledge of the combination medication dose in the volume specified.

Certain fields of the grid do not specify the volume, but rather state "date/time" requiring another click or pop up screen. The immediate knowledge of tylenol dosage in mg is directly related to understanding and preventing excessive doses. In the subject, 10 ml of acetaminophen-oxycodone is indicated as having been given 3 times over 4 hours. That means that 1950 mg of tylenol was administered in 4 hours while the patient was in a state of starvation and receiving other medication that increase the effects of tylenol.

This dose would equate to 11,700 mg of tylenol over 24 hours, nearly 3 times the maximum daily dose in otherwise health people. In the ensuing days, the patient developed acute renal failure, presumably acute tubular necrosis, and died. In the absence of other etiology, the excess tylenol was the culprit. This was not considered as etiology ante-mortem. The counterintuitive screen impaired the professionals. The pharmacist did not recognize and stop the medication, the nurses administered it, and the excessive dose, clinically meaninglessly listed as a volume of 10 ml -given 3 times in 4 hours- of acetaminophen-oxycodone, was missed by the physicians. Adverse events have been ascribed to "user error" by vendors.

The device offers a potent propensity to life endangering oversights. There are other screens on this device which present information that interfere with clinically useful visualization of data. [Who designed these screens, I ask? Clinicians, or business IT personnel used to designing inventory systems for widget control? - ed.] The data does not flow to the professionals. It is not represented in a meaningfully useful manner.

The professionals need to hunt for it. As such, the user unfriendly screens [see this link on mission hostile HIT - ed.] impair safe medical care consistent with the impediment to expedient professional understanding of what, exactly, is the dose of medication and how much was administered to the patient. This sentinel case of death is directly attributed to user unfriendly screens on this device.

How many cases like this, as well as "near misses" related to health IT go unreported, nationwide and worldwide?

As in my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT", nobody really knows; these devices are unregulated with no requirements for reporting.

However, let's roll it out nationally anyway, because HIT will deterministically "revolutionize" medicine. Just ignore those spoil-the-party, man-behind-the-curtain prattle from writers like these.

We can safely ignore all contrarian research and literature, of course, as we all know HIT will revolutionize medicine from the definitive certainty of HHS in "The 'Meaningful Use' Regulation for Electronic Health Records", NEJM, Blumenthal and Tavenner (10.1056/NEJMp1006114, July 13, 2010):

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

[Except for those who haven't - ed.]

And our government's called BP Energy Company cavalier?

I offer no additional comments.

-- SS

Did EPIC CEO Judy Faulkner of Epic declare that ‘healthcare IT usability would be part of certification over her dead body?'

At the HisTALK blog 5/31/10 update, a site with thousands of readers involved in all aspects of health IT, the following anonymous (at this point) report appeared:

From Tabula Rosa: “Re: EMR usability. At one of the ONC Policy Committee meetings, [founder and CEO] Judy Faulkner of Epic supposedly declared that ‘usability would be part of certification over her dead body.’ I wonder if she has similar sentiments about making software accessible to people with disabilities?” Unverified. This inspired my new poll question – keep reading below.

Epic Systems Corporation is one of the largest health IT vendors in the U.S.

If this report is true, it would have very, very serious implications towards the healthcare IT industry's attitudes about the usability - and ultimately the safety - of its products.

The essential nature of usability and the relationship to safety is not an issue for debate - period. It was settled long ago in relation not only to IT, but also to devices and machinery that use IT. For instance, see the mid 1980's wisdom written for the U.S. Air Force on user interfaces at my eight part series on mission hostile health IT user experiences at http://tinyurl.com/hostileuserexper. Microsoft and other responsible IT vendors spend billions on usability research.

I think it incumbent of the U.S. Office of the National Coordinator for Health IT, and its leader Dr. David Blumenthal, to confirm or deny that such a statement was made, on or off-record, at an ONC policy committee meeting, and if it was made, its exact context.

If it was made, it would raise the following questions:

• Would its utterer be saying this out of concern that their products have usability deficiencies that competitors do not, and that are not correctable in a short time frame?
• How much concern would such a statement indicate for the complex jobs of physicians, nurses and other clinicians whose safe conduct of their medical obligations depends on health IT?
• How much concern would such a statement imply towards the injured and dead bodies of patients affected by health IT of deficient usability?
• Since the CEO sets the tone for their company and has the ultimate responsibility for its conduct (and its Board of Directors as well), would such a statement reflect willful negligence and perhaps criminal conduct?

The last question is pertinent, for if, say, the CEO of Boeing were to relate that "usability of the control systems of its aircraft would be an FAA certification requirement over his or her dead body", or the CEO of oil drilling companies said same about their instrumentation that helps avoid underwater blowouts, I believe it would rise to the level of criminally negligent conduct.

This is all the more pertinent to me, as my relative was just seriously injured by a medication error that appears to have started with the med list in an EMR.

I am seriously wondering, in fact, if the average hospital has the gravitas and political and technologic maturity to truly implement health IT so that the technology is uniformly beneficial, instead of spontaneously harmful, to meet the needs of the grandiose plans for national health IT.

The lack of seriousness, petty political fights, and technological dyscompetence and incompetence I have noted in my 20 years in this field do not seem surmountable in any time frame I consider "soon."

Here seems to be the health IT industry and hospital MIS department view of healthcare IT, as some sort of game to be played for profit, power and political advantage:




-- SS

Why The Apple iPad Will Not Revolutionize, Change the Game, Transform or Create New Paradigms in Medicine Anytime Soon

The announcement of the Apple iPad has been accompanied by the usual irrationally exuberant, buzzword-laden statements and bellicose grandiosity from the IT punditry about how it will "revolutionize" or "transform" medicine.

However, this will not occur anytime soon, for in medicine, the device may help solve a portability and visibility problem (compared to PDA's), but it will not solve this problem: the mission hostile user experience.

The solution to that problem will require significant human magic.

-- SS

Finnish EHR's Clumsy, Mission Hostile, Consume Doctors' Precious Time

It seems common wisdom in the U.S. that the "Europeans are way ahead of us" in computerized medicine.

Perhaps the common wisdom is not so wise. This from Finland:

HELSINGIN SANOMAT
INTERNATIONAL EDITION - HOME

Clumsy computer systems consume doctors’ time

When Arto Virtanen, a doctor at a public health clinic, wants to access the information of a young patient, 12 windows of different sizes open up on different parts of his computer screen. Virtanen has to deal with each of them every time a patient visits him for routine postnatal care.

“It used to be that a municipal doctor would see six or seven patients in an hour, when documentation was not at its present level”, Virtanen says. “Then there came more paperwork, and four patients were seen in an hour. Now if a doctor wants to read all the information about a patient in the information system, there would only be time for consultations with, say, two patients in an hour.”

Clumsy computer systems are already seen as a danger to patient security, says Tiina Lääveri, a member of the board of the Finnish Medical Association, who has acquainted herself with the various systems.

Clumsy retrieval of data is one source of danger. Important information can disappear into the nooks and crannies of the software.

“There can be 100 pages of text without any summary, out of which a doctor should find information in a couple of minutes."

In hospitals, the systems do not separately tell nurses about changed dosages of medicines.

“The information is there, mixed in the mass of all of the rest of it, where it gets lost.”

In addition to causing outright dangers, computer systems waste precious working hours. In addition to actual medical data, the computer requires the recording of various items of statistical information.

Patients can see the problem as well. Up to 43 per cent of time reserved for a patient with an appointment to see a public health doctor can be spent dealing with a computer, according to a study published earlier this year in Lääkärilehti, the publication of the Finnish Medical Assotiation.

A national health archive now under development would not help things, as data would still be handled with existing software.

“Software companies have started to become interested in listening to users only in recent years”, Lääveri says.

Virtanen in Rajamäki would like to see more compatibility between systems. “There could be a common database, which should be easily accessible by a network browser”, Virtanen says.

“It might also be constructed according to what this working process really is.” [You don't say? - ed.]

Can health IT be any more mission hostile than this? (Unfortunately, the answer to what started as a rhetorical question is probably "yes." See this post on the US military's EHR AHLTA, and see my eight part series "Are Health IT Designers, Testers and Purchasers Trying to Harm Patients?" on mission hostile commercial HIT starting here.)

Reports of difficulty in EHR Utopia have leaked out of other European countries such as the Netherlands and Germany, not to mention the UK.

The most startling observation is that “software companies have started to become interested in listening to users only in recent years."

What manner of cavalier simpletons and opportunists populate such health IT companies?

-- SS

Addendum:

It appears AHLTA may be a bad as it is due in part to "politics as usual" a.k.a. corruption. See "Company won earmarked funds for work on military health records." If such conduct has been commonplace during AHLTA'a tortured history, it could explain just how AHLTA became as terrible as the senior military officials describe it in the linked article above.