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

A "safe" technology? Factors contributing to an increase in duplicate medication order errors after CPOE implementation

An article "Factors contributing to an increase in duplicate medication order errors after CPOE implementation" by Wetterneck et al. appeared recently in JAMIA (JAMIA doi:10.1136/amiajnl-2011-000255).



It is not available free, but the questions I want to raise are valid just from the abstract available free at the above link:

Abstract

Objective To evaluate the incidence of duplicate medication orders before and after computerized provider order entry (CPOE) with clinical decision support (CDS) implementation and identify contributing factors.

Design CPOE with duplicate medication order alerts was implemented in a 400-bed Northeastern US community tertiary care teaching hospital. In a pre-implementation post-implementation design, trained nurses used chart review, computer-generated reports of medication orders, provider alerts, and staff reports to identify medication errors in two intensive care units (ICUs).

Measurement Medication error data were adjudicated by a physician and a human factors engineer for error stage and type. A qualitative analysis of duplicate medication ordering errors was performed to identify contributing factors.

Results Data were collected for 4147 patient-days pre-implementation and 4013 patient-days post-implementation. Duplicate medication ordering errors increased after CPOE implementation (pre: 48 errors, 2.6% total; post: 167 errors, 8.1% total; p<0.0001). Most post-implementation duplicate orders were either for the identical order or the same medication. Contributing factors included: (1) provider ordering practices and computer availability, for example, two orders placed within minutes by different providers on rounds; (2) communication and hand-offs, for example, duplicate orders around shift change; (3) CDS and medication database design, for example confusing alert content, high false-positive alert rate, and CDS algorithms missing true duplicates; (4) CPOE data display, for example, difficulty reviewing existing orders; and (5) local CDS design, for example, medications in order sets defaulted as ordered.

Conclusions Duplicate medication order errors increased with CPOE and CDS implementation. Many work system factors, including the CPOE, CDS, and medication database design, contributed to their occurrence.

Duplicate orders can result in over-medication, failure to discontinue, or other medication errors if not caught. They by definition increase risk.



The questions are simple:



Considering that this was a "Northeastern US community tertiary care teaching hospital", not a small hospital in a remote town somewhere lacking in HIT experience, and that "duplicate medication order errors increased with CPOE and CDS implementation", is CPOE:

• A safe technology, in a practical sense in the complex clinical setting (with complexities that are 'Hiding in Plain Sight'), in 2011?
• A technology ready for sanction-enforced national rollout?

I leave it to the reader to decide.



-- SS

CPOE Cesspool

An accomplished physician who read my post on CPOE at Memorial Sloan Kettering causing medical errors and near misses, and lack of FD&C Act regulation of health IT medical devices, relates the following:

So I want to stop medications on a patient. The device only allows me to stop one at a time, and for each one, it requires me to type in a reason.

Then, I get another pop up screen to enter my password.

Six clicks and two manual entries to stop an aspirin, not counting the click to get to the med list. [What a valuable use of physician time! - ed.]

Also, I have found that when I want an order for something that is labor intensive to enter, and I ask house staff [trainees - ed.] to do it, I get balking as to why I want that treatment or infusion.

The arguments, I have found, are not really about the treatment. They are about their avoiding the pain in the ass of having to deal with the user unfriendly screens for that order.

The doctors all put up with this.

Yet for some reason this waste of valuable clinician time due to antediluvian HIT design, and even wild goose chases for critical medications such as in my Apr. 5, 2011 post "Mission Hostile Health IT Obstructs Physicians From Ordering Life Saving Drugs In Critical Emergency", are considered "progress" in medicine.

World class medical centers such as Sloan Kettering consider CPOE a "critical vulnerability" towards near misses and outright medical errors.

Still, this IT toxicity is considered "progress" right up to our Department of HHS and POTUS.

Why?

-- SS

Toward Meaningful Usability: Five Keys to Creating Physician- Centric CPOE (Wait - The Terms "Safety", "Risk" and "Error" Are Missing)

In a 2011 "White Paper" from a company PatientKeeper entitled "Toward Meaningful Usability: Five Keys to Creating Physician-Centric CPOE" (PDF), an organization whose motto is "Enabling Physicians to Focus on Patients ... Not Technology", I again note a common phenomenon.

Certain verboten terms are absent.

What might those terms be? More on that in a moment...

They speak of "the failure of CPOE":

The failure of CPOE to date can be attributed to many factors that ultimately lead to a lack of physician adoption. CPOE systems have historically been designed to support the workflow of the departments responsible for fulfilling the orders rather than the physician workflow around entering orders. As a result, entering orders electronically can take significantly longer than written or verbal orders and often requires the physician to change the way they currently practice medicine.

That's a problem, considering the following observation (paraphrased from a "why-pharma-fails" post at this link):

"The machine was made for Clinicians, not Clinicians for the Machine."

But still, words are missing from the White Paper. Again, more on that in a moment.

... Hospitals often purchase CPOE on the premise that standardization of care through evidence-based order sets is the optimal way to improve patient care delivery and reduce healthcare costs. In fact, most standardized care is not
supported by evidence so spending months or even years to achieve order set consensus only serves to delay implementation and use while increasing the overall cost of the order entry system.

Well, yes, but where are those missing words?

Most CPOE systems expose physicians to all clinical alerts regardless of severity.
The preponderance of these alerts disrupts the ordering process, leads to alert fatigue, and results in frustration on the part of the physician. Finally, the number of available workstations, including those on the hospital floors and in patient rooms, is limited, and physicians may have to wait in queue to enter their orders. This may lead to an increase in verbal orders from the physician to the nurse, pharmacist, etc. as well as frustration with a process that requires more physician time than simple pen and paper.

There must be a lot of frustrated doctors out there. Still, the shibboleth terms are missing.

Cited are the usual KOL's:

1 D. W. Bates, J. M. Teich, J. Lee et al., “The Impact of Computerized Physician Order Entry on Medication Error Prevention,” Journal of the American Medical Informatics Association 6 (July/August 1999): 13–21.
2 D. W. Bates and A. A. Gawande, “Improving Safety with Information Technology,” New England Journal of Medicine 348 (June 19, 2003): 2526–34.
3 Jason Hess, KLAS Enterprises (Orem, Utah), “Are We There Yet? Getting to Meaningful CPOE Use”, July 13, 2010

Still no mention of the missing critical terms.

The next generation of CPOE solutions must ultimately save physicians time, rather than simply being time-neutral. Otherwise, they will suffer the fate of most previous attempts to implement this required functionality – at the cost of improved patient care, better outcomes, and lost ARRA stimulus dollars.

In other words, the worst-case scenario is wasted promotional dollars and maintenance of the clinical status quo.

Still, key terms are missing.

What are those terms?

Here they are, the unaccounted-for outcomes of CPOE and its toxicity in its present form:

• Safety (as in, "reduction of")
  
• Risk (as in, "of injury, increased")
  
• Danger (as of, "putting patients in")
  
• Error (as in, "the outcome of toxic HIT")
  
• Harm (as in, "injury and death")
  

This was no mere White Paper. A more appropriate term might be a "Snow White" paper:

CPOE, An Enchanted Technology. Find the Prince!

Health IT, including dysfunctional and toxic CPOE, causes frustration among doctors. CPOE failure is merely "physician nonacceptance."

But the frustration among injured or dead patients and their families seems never to be mentioned or considered in this industry.

I pointed out that similar terms were missing from the PCAST (President’s Council of Advisors on Science and Technology) report on health IT at my Feb. 2011 post "Brief Comments on the PCAST Report on Health IT."

Shhhh!

-- SS

Medical center has more than 6000 "issues" with Cerner CPOE system in four months - has patient harm resulted?

As I have written at Healthcare Renewal before, computerized physician order entry systems (CPOE's) are known to present risks to patients through induction of medical errors.

This technology is held out to be ready for national diffusion, right up to the POTUS. Per ONC director Blumenthal in the July 13, 2010 NEJM:

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.

Vendors deny major problems with their CPOE and other health IT products.

The true story is a bit more complex.

Fortunately, there are some medical centers who are open and honest about HIT problems. These medical centers seem a rarity. However, those that do share are actually conducting themselves in an honorable and mission-true manner, per Joint Commission Safety Standards, the ethics of the medical profession, and the expectations of the public. They should be commended.

One such example is Munson Medical Center in Michigan.

From the October 2010 "News for Physicians affiliated with Munson Medical Center" newsletter, a large medical center in Northern Michigan, about more than six thousand "issues" with their Cerner CPOE:

POE Program Continues to be Improved, Enhanced

The Provider Order Entry (POE) program continues to be improved. Since implementation in June [four months ago - ed.], more than 6,000 issues have been reported. Issues are defined as an aspect of the program not working as intended [does that include medication and treatment errors and 'near-misses'? - ed.], process issues [can these 'issues' kill? - ed.], education needs, or PowerPlan [Cerner - ed.] change requests.

About 600 of these remain open. Issues are prioritized by the POE Team and addressed according to existing standards.

One wonders how many of those 6,000, and how many of the 600 remaining "issues" fall into categories of "likely to cause patient harm in short term if uncorrected" or "may cause in patient harm in medium or long term."

I note that Cerner CPOE is not a new product, nor are similar products from other vendors also afflicted with long lists of "issues." That there could be more than 6,000 "issues" at a new site suggests deep rooted, severe problems with CPOE specifically and health IT design and implementation processes in general.

Did patient harm result here or at other CPOE sites (using products of any vendor, not just this one) that had hundreds or thousands of "issues"? We may never know.

That national rollout is mandated as if this technology were proven, safe, and plug and play is a scandal of UK NPfIT-like proportions.

-- SS