To Err is Not Just Human

In the article How to Eliminate EHR-Based Medical Errors, presents a list of computer errors that affect patient care. While many tend to blame poor programming and software glitches, these developmental issues are only partially to blame. The ultimate culprit is a lack of standardization in EHR systems, in general. Sufficiently standardized systems would make it possible for a physician to enter data at one hospital, and when at a different one, use the very same methods.

 

Unfortunately absence of standardized interfaces is ubiquitous in our currently technological society.  For example, how often does one go to one store, say a grocery store, and when trying to pay for goods, has to deal with a card reading device that is entirely different from the adjacent store.  One has to figure each one out independently. If spending too much time shopping, one could easily run into ten different interfaces.  Quite maddening.  But that is the normal world, one would expect better of medicine and medical technology. Or is that expecting too much?

Some examples of the confusions encountered include:

1.  Data base/CPOE’s (computerized physician order entry systems)have inconsistent dosing for medications, or manages to switch the dosing between 2 medications
a.  Solution is national data base for CPOE. The data base can “live in the cloud” and be accessible to all

2.  Artificial intelligence that is artificial but not intelligent, such as incorrect weight adjustment for natural growth
a.  Solution –data base that is accurately age and weight adjusted and that catches irregularities and sends notification.

3.  Failure to inform clinician of critical lab information is a major problem.  The more clinicians are depending on technology, the more they naturally depend on them to flag problems.
a. Solution –warning system of critical lab results---coordinated through a national data base for national CPOE, mentioned above.

4.  Prescription with wrong decimal point for dangerous medications. Deadly !
a.  Solution—standardized CPOE/Pharmacy and automated safety testing.

5. Duplicate patient records.  How difficult is it when Patient Sam Q. Brown enters and registers as Sam Brown.  But the computer is thrown off by the absent Q…..and then a second record is created, one that does not have all the important information that Sam Q needs to have in place.
a. Database error created by expected variance in human nomenclature. The error should be trapped and the medical team prompted to sort it out and reconcile the records. Google does this, why can’t medicine.

6.  OUTPUT is “Gobblygook” at best. A combination of typing, cut and paste, macros, mini-macros, and  “computerize” that makes no sense. The inputs are all given the instruction to create text. There is no instruction set that can be made which will create automatic meaningful text.
a.  One solution may be greater use of voice recognition. For example, Voice Activated Technology (Dragon) allows a clinician to dictate several common sense sentences about what really happened during the encounter.  Siri does pretty well on this too.  Apple, Dragon do it, why not get medicine more fully on board?

7.  Scanned documents sent to wrong patient.
a.  No fail safe mechanism exists for stupidity or incompetence

8.  Action items never were seen or acted on by the clinician.
a.  Programming issues/inappropriately mild alerts can be blamed, often
b.  Often, it is difficult for a provider to comment on action taken because there is an inability to easily add addendum.  Developers should really try to make the systems at least better than paper in this regard.

The fundament problems are lack of standardization, easy navigation, appropriate warnings, and ______________ fill in the blank. Meaningful use money would have been better spent on a national data base and CPOE. Each vendor could then create their own system with built-in universal knowledge, integration, and interoperability as a baseline.

The Medical Errors Debate

A recent article published in the BMJ has caused a furor in the medical community claiming that medical error is the third leading cause of death in the US.  In the article Sensationalization of Medical Errors: Breaking Down the Data In Order to Improve Patient, the author makes a careful analysis of the data used to come to these conclusions. The methodology of the data collection makes the claims of the study grossly overstated, but does deliver an important message to the medical-industrial complex. 

Wikipedia states a medical error is an error that is a preventable adverse effect of care, whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome, behavior, infection, or other ailment.

This is where the complications arise. Medical errors are and can be dangerously detrimental to certain patients but whether this is a cause and effect relationship can be very difficult to prove. Medical errors are contributory factors.

Medical errors run the gamut of poor communication, failure to diagnose in a timely manner (a complicated legal question), improper medications, not accessing the right data at the right time (a failure of interoperability of the modern Electronic Health Records, multiple intellectual and emotional biases of the providers, system errors (most common) and etc.

Whether a medical error directly cause a death, was contributory to what degree, and/or irrelevant would have to be carefully ascertained on a case by case basis. Making generalizations on death certificates where the data is frequently incorrect leads to suspect conclusions. 

The bottom line is that the medical community should take this article as a warning shot that there are significant problems in the system. Crying foul is not a solution. Moreover, the use of the word “cause” with respect to medical error is totally inappropriate.  We well know, too well, that “proximate cause” without significant other “contributory” factors, is necessary in a tort case. It is no different here.  When the disease is the underlying etiology, and the healthcare system does its best, but fails, as it naturally does now and then, what is the underlying cause?

Certainly minimizing what are termed “errors,” but should more properly be termed “imprecisions” or “flaws” is a goal to which all strive.  But as imperfect beings, subject to many flaws, a perfect medical world is not going to happen. Preventable means zero margin for the humanity under which we all labor. All we can do is our best to keep the imperfections minimized.

Fixing the present Electronic Health Record Systems to give accurate, clinically specific data would go a long way in solving some of the problems. Artificial intelligence giving specific warnings would give the provider an immediate second opinion that may help guide the proper course. Finally society has to come with grips that medical art and science is not perfect and never will be.

The Nature of Diagnosis

One of my fundamental thoughts about the diagnostic model in medicine is illustrated by this case from the week's NEJM titled The Deficient Diagnosis.  The authors' comment in the closing paragraph on "circuitous diagnostic route" could (should) be applied to many other clinical situations. That is, most diagnostic routes, except the very obvious are indeed circuitous. And it is this aspect of medical decision refinement that should (or so I think) eliminate the term "errors" from the mix.

Instructive, especially to us, is the child's prior presentation, and the ultimate necessity of coming through the ED to find the true path to a successful diagnostic "route."

Were there errors prior to acquisition of a clinically actionable entity?  I don't see them that way.  Or maybe "hell no!"  This is the nature of medicine, in general.

Compare to someone who arrives with chest pain and acute ST-T elevation. A no-brainer, so to speak. But throw into the mix someone whose EKG and two enzyme sets are  normal, scheduled for a stress-test in 72 hours, and dies of an acute MI in 40 hours. Error? I don't see it that way.  Safe-route?  Not for that patient.

So diagnosis is not static, but dynamic. Even in the NEJM case, once action ability is reached, is that the "final" diagnosis ? (Of course "final diagnosis" is a term we use but applies in most cases to the moment of discharge, highlighting its inherent temporal nature) .   How many times have diagnostic pathways forced our otherwise non-compliant minds into submission to diagnosis' dynamism? Take hypoglycemia --> poor insulin administration --> (wait) Addison's disease --> (wait again) Multiple endocrine adenopathy.  Or chest pain --> acute MI --> aortic dissection.  And on and on.

Diagnosis is not, and should not ever be, a static entity.  What are called "errors" therefore are indeed (expected?) steps off the fastest route.  (That route of course is faster if the patient comes to the ED !!).  I think it would serve the diagnostic error community (if there is one) well, and the emergency medicine community (to which we belong) well if this were better encountered theoretically.  Hence, if done, a path to actionable diagnosis is best served when the time-frame to it is the shortest possible. And the ED is the best site for that !!

Can Defensive Medicine Decrease Lawsuits?

The authors of Physician spending and subsequent risk of malpractice claims: observational study try to determine whether increased clinical use of diagnostic resources serves to decrease malpractice claims. While they were able to show an association between greater physician spending and reduced risk of malpractice claims, they were unable to determine an underlying cause for increased resource use.
That is, the reason (cause) for this association is not entirely clear.  We can speculate, of course, but it is wise to remember that doing is simply that, speculation.  

 
Consider two possible causative explanations, one employing a defensive approach, and the other an offensive approach.  Opposite forces, same result. How?  In the first, physicians studied may actually have practiced defensive medicine, with the mindset of defending themselves from lawsuits. In the second, they have practiced offensive medicine, being more careful for the benefit of their patients, and being little influenced by defensiveness.   In either case the same association would have been shown: more tests, less suits.  Indeed, it could be the case that more careful doctors make more accurate diagnoses, and have fewer suits.  The only difference between these obverse sides (defensive/offensive) is motive.

From the defensive side, the authors give multiple reasons why malpractice occurs where some skill improvements might be of benefit, including poor interpersonal relationships and impaired communication abilities.  From the offensive side, when one is doing one’s best in behalf of a patient, there is little that can be done about unanticipated bad outcomes, unexpected diagnostic errors, cognitive errors, and systems errors. These happen to the best of us.

Nevertheless, defensive medicine is a fact of life for most physicians in the United States. It is present to some degree, even if slight, in most of us. It is the “Elephant in the Room.” Even though multiple studies contend that malpractice risk is overrated, those of us who have practiced for more than a few decades (or more) know that a multiplicity of factors get poured into each clinical decision, and no less into the question of what tests to run. While defensiveness may creep in now and then to some degree, it is not the whole picture, as it simply does not control clinician minds. Most of us make decisions based upon that we think will benefit the patient, not upon what will keep us out of court.  True, a good outcome is less likely to result in a suit, but we tend not to live in a pessimistic world where every patient is a lawsuit waiting to happen. Some believe that physicians do think that way, but it is an untrue picture because most practice optimistically.

Yes, there are those who have allowed defensiveness to rise to the top in their decision-making.  But not all in the house of medicine have done so.  No, not all, and more precisely, only few have defensiveness dominate.   Of course, for each of us, there have been times it has become more of a force than we would like, perhaps when under stress, or perhaps when the memory of encountering a plaintiff’s attorney is still fresh. But for the most part, we get back to practicing primarily for the sake of patients, letting potential litigation chips fall where they may. We do that largely because we know that lawsuit apprehension is not what really motivates us, nor what is best for our patients.

Unfortunately, a big part of the malpractice setting is the psychological and emotional damage a suit inflicts on defendants. Loss of money may happen; worse are losses of self-esteem, meaning, and identity. Then there are the potential appearances of alcohol abuse, substance abuse, and marital discord. These are only a few of the untoward consequences that accompany becoming a malpractice defendant.  There is also the chances one may lose their job or that potential advancement may be spoiled. The state of Florida has a 3-strike law that can actually force one to leave the state. We have been told that being referred to the State Department of Regulation can be a worse experience than being sued.

A provider who is currently, or was previously, a defendant must live with a cloud that follows him or her around, raining thoughts about the “mistake” that may have harmed someone. Whether fault really was present is often irrelevant when the defendant bears psychological consequence. Endless pressure to perform at 100% accuracy in a world where errors are not taken lightly, may, over time, extract a toll on the joy and satisfaction practicing medicine should otherwise have. One sometimes hears youths, as well as mature ones, say that medicine can be a great career, but there are easier ways to make money.

It is important to be cautious and, as we have noted, caution can lead to greater expenditure and resource utilization.  But, as we have noted, cautiousness may be directed not only toward oneself (defensively, by the ordering physician), but also toward the patient (offensively, to be sure nothing important is missed).  Now, when we, or one of our loved ones, becomes sick, don’t we want the cautious, caring physician, on the offensive in your corner, whether his ordering stats appear to be “defensive” or not?

Are there any solutions to this conundrum? Having a non-combative no-fault malpractice system (as in Australia) would be a good start. While a no-fault approach does not eliminate malpractice claims, it enables most injured patients to get their day in court without demonizing the provider.

Communication and system issues are prime sources of patient dissatisfaction. Still, because little can be done to reverse a bad outcome, a no-fault system has definite advantages.  It has the ability to provide resources for the patient and the family, while simultaneously protecting all concerned, including the physician.

In conclusion, it is only logical that providers might order more tests to protect themselves from all the downsides of lawsuits.  On the other hand, it is also only logical that physicians order tests in larger numbers to protect their patients from bad outcomes.  How do you tell these apart? These two paths to more testing are indistinguishable.  But in either case, even though the provider is being risk averse for two apparently different reasons, ordering more tests will not prevent lawsuits.

Cost of a Click

In the article The Hidden Cost of a Click, the author states, “A bad user interface can turn an EMR/HER into a minefield of medical errors and inefficiency.”

 

At the present time, the number of clicks necessary to fill out a chart is endlessly time consuming and non-productive.  The cost per click is now being calculated and quantified.  The work flow is slowed down and there is a real-not imagined- price to pay.

One solution is to create an auto-flow sequence that is tunable by site or provider and that comfortably guides the clinician from one area of the chart to another in a logical-customary- sequence.  If an out of sequence entry is desired, this should be easily accomplished.  A system with automatic guidance will eliminate the need to figure out where one should go next, especially if one is interrupted.  When it is acknowledged that one area is complete, it then moves to the next area when documentation is continued or resumed.  Once the area is completed, the list shrinks.  Your favorite click might be auto-sequenced.

An example sequence could be...

• Vital signs
• Triage sheet
•  Past medical history
•  Nursing notes
• History and PE in logical order
• Medical decision making
• CPOE
• Lab and x-ray results
• Clinical course
• Final diagnosis
• Disposition
• e-Prescribing
• Patient education
• Follow-up
• Review nursing notes
• Sign the chart

Navigation would be significantly simplified.  The provider can always go to any area directly and in any order.  Nursing notes might be reviewed, if easily accessible.  Training would be simplified and hopefully stress-reduced.

Doctor Errors Kill 500,000 Americans a Year

The article published last week the author claims that Doctor Errors Kill 500,000 Americans a Year. 
The Institute of Medicine in 1999-2000 released a report that 44,000-98,000 patients a year die as a result of medical errors.  The main categories of error at the beginning of the 21st century were diagnostic, treatment, prevention and system errors.

 

In this article, only about 15% of a decade later, raises that number to 500,000.  Is 500,000 accurate?  Well, that depends on how the counting is being done, as it is an inherently complicated analysis to determine whether "a specific action or inaction directly lead to a death".

 

 

Causality: is the relation between an event aka the cause and a second event aka the effect, where the second event is understood to be a consequence of the first.

 

A chief aspect of the complexity is the blur that naturally occurs between events that are simply associated in time, and events that are causally linked.  When events are merely associated with one another, they may appear to be causally linked because one comes before, and the other occurs after, but causation is nevertheless absent.  When events are actually linked by causality; however the earlier produces or directly contributes to the later.

 

Sorting this out may seem achievable, but often is not.  moreover, for the purposes of health-care analysis or litigation, it is quite easy for one side or the other to make before-after appear like before caused after.  When cause and effect are obvious then the attribution of causality is clear.  Usually this only happens in simple cause-effect circumstances.  Say a person weighs 500lbs and is known to have eaten three gallons ice cream nightly for the past 15 years.  In this care, the cause-eating ice cream- is certain without any doubt.

 

But in medicine, things are rarely ( or never) so simple.  For example, suppose a man presents to the ED having been brought in by rescue after a car accident.  He begins to have some chest pain, and an EKG is done, which shows an Acute MI aka heart attack.  Now what was causal regarding the MI?  Was it the physiological stress of the car accident, the psychological and physical stress of the rescue transport, or perhaps his wife yelling at him before he left home?  Could the MI have occurred before the accident, and the physiological stress of the infarction have precipitated the accident?  Or, could he have bee exposed to some drug or the substance decreased his coronary flow, and been a definitive causal factor?  In this example, no one knows, and claims of such knowing are highly suspect to be thoroughly biased, and likely influenced by funds on the table.  There are simply a panoply of associated factors present, any one of which, or any combination of which, might have been causal.  The same is true with respect to medical errors, except in this field of inquiry, causal factors within the system itself are the most dominant associated factors for which individuals in the system are frequently blamed.

 

Indeed those who study medical errors fully are the first to acknowledge that prevention of such errors are for the most part systemic issues.  That is, humans are simply not error free; systems on the other hand, can come much closer by putting into place checks and balances to catch errors whenever possible.

 

In heath-care litigation, the claim made does not take into account the complexity of determining what really caused a bad outcome.  The number claimed by the Institute of Medicine was considered outrageous at the time, and for good reason; indeed this number seems high and sensationalistic.  They clearly equated bad outcome with caused by an error in care.

 

The numbers are less relevant than recognizing the presence of an underlying system problem that needs fixing.  Recently, system analysis experts have working toward a plan where the individual practitioner is not the recipient of the total blame, but a pathway to fixing the problems for all involved.