The Ether Way

The trouble with tribbles...

All bad precedents begin as justifiable measures.  -Julius Caesar

Desperate measures for desperate diseases   

So, as my co-author, Mike reminds me, I've been absent a looong time. Not without reason, mind you; it has been a tough year, and the clouds are only now beginning to clear. More on this later,( and in another post), but as both a provider and user of the health finance system (and as a beneficiary and victim in both roles, I might add), I have a pretty interested vantage on the healthcare reform ball-game.

So, today's post is about Atul Gawande's gate crashing, delivered suspiciously-on-schedule article, "The Cost Conundrum" which appeared in a recent issue of the New Yorker. You can find it here. Every word is true, (validated by my personal experiences), as far as it goes... 

If you are short on time or attention, link to the article, and skip what I am about to say. What he says is more interesting.

Yo may recall that Gawande, a general surgeon from the midwest, a physician child of physician parents, was a principal in the Clinton Healthcare reform braintrust as a young man. He subsequently completed a surgery residency, published a couple of books of New Yorker essays, and generally manages to nicely write stuff that is interesting to lay readers and medical professionals at the same time. (medical professionals might like his essay "On Washing Hands" which appeared in the NEJM. You can find it here.)

I don't want to critique "The Cost Conundrum" here; rather, I want to justify my post title. I have received links to this article now three times, excluding the one from my co-author, Mike, which was inexplicably lost in the ether (or my untamed gmail account...) That's incredible, exceeded only by solicitations to invest in Nigerian phishing schemes to move large sums money into my bank account, and the stupid morphed picture of the pig-nosed child with "swine flu." To use the term of art, the Gawande article has "gone viral," and will be a powerful influence in the coming reform battle and in Dr Gawande's role in that debate. (Oh, if you don't get the allusion in the title, go find the episode of star trek; it's worth it...)

So, finally and surely as Roosevelt exploited radio and Kennedy, TV, the Obama administration has mastered the web, not only as a tool of campaigning, but as a tool of legislating, which is a fish, as they say, of another garage (sorry). I am reminded as I write this, that much of what the Obama campaign did was based on foundation laid by a physician, Howard Dean, and he deserves an acknowledgement.

I muse, that the pace of technology being what it is, the current Iranian dissident movement is the first full-bore application of the next generation technological socio-political weapon; texting and twittering. I shall leave it to my betters to draw the obvious analogies between politics and war, and the role of new technologies in determining such contests. I will say that, where once I understood technological advance to be primarily physical (faster computers, more powerful weapons) I have come to a broader view which includes less tangible tools, i.e. ideas, logisitical advances, and the like. My more thoughtful colleagues will be saying "well dah," but after all, I was primarily an engineer.

I will not enter the fray on the merits of the current round of healthcare reform. But my initial quotations summarize my opposing feelings adequately, anyway.

Lost in Cyberspace

Once again, I have to thank my colleague Richard Cook for calling to my attention several news items, all of them relevant to my recent posts about Information Technology and health care.

Backround: Wait-times in England's NHS are long, very long, and have been a source of growing dissatisfaction with the NHS.  The resultant political pressure has produced programs to 'manage' and decrease wait-times. Recording and reporting wait-times has become a major marker of performance for the NHS.

Claim: With the power of computers, we should be able to very accurately track every patient and their progress.  A computerized information system will enable the NHS to very accurately track wait-times.

Reality: One of the largest NHS trusts in England has 'lost' lists containing at least two thousand patients.
What is the consequence? All of these patients waited well in excess of the 18 weeks (yup, you read that correctly - more than 4 months) for the treatment that their GP prescribed.

http://www.computerweekly.com/blogs/tony_collins/2009/04/barts-responds-to-criticisms-i.html

http://www.computerweekly.com/Articles/ArticlePage.aspx?ArticleID=235815&PrinterFriendly=true

How did this happen? No one knows for sure.  There are at least two plausible explanations; neither of them is a cause for optimism.  The first is that the electronic tracking system is so complex that it is almost impossible to track information as its purchasers and operators intend.  This is very plausible. The second possibility is that the NHS trust, recognizing that it didn't like the report it was going to generate(e.g. their wait times were terrible), decided to torpedo their IT system, which would deflect criticism from their overall inability to deliver quality care in a timely fashion.  There are other possible explanations, but these two suffice.

To their credit, the administrators of the trust elected to forego issuing a mandatory report on wait-times, because they had absolutely no confidence in the data used to generate the report. So much for precision tracking.  Sadly, this precedent will make every consumer of information eminating from the NHS wonder about its reliability.  Bad data, whether favorable or unfavorable, can only generate further problems for the NHS.  Discussions based on conjecture are worse, but seem inevitable.

Champions of CHIT will contend that experts should, given time and resources, be able to implement a system that works.  The experience NHS thus far reveals the lie beneath this. Two of the 4 major contractors have walked away from  $ 1 billion + deals, taking a loss just to get out.  The is a maelstorm of criticism of the product of the remaining vendor. 

http://www.guardian.co.uk/society/2009/apr/28/nhs-it-cerner-computers-hospitals

We are forced to conclude while it is possible for CHIT to permit precision tracking of patients, that there are no vendors on this planet that have been able to generate a product that might work for the NHS, at least not yet.

This problem is not unique to England, Australia has similar failures looming on the horizon:

http://www.theage.com.au/articles/2009/04/16/1239474999842.html

The Australian story also suggests that the system they have implemented has little or no capability to improve medication safety, one of the major motivators of the mandates to procure such systems.

One final point: These failures receive much less play in the English press than they would in the US press, because all of the 'subscribers' to the NHS have become accustomed to the exceedingly long wait-times associated with the system.  They're not subscribers or consumers as much as they are sheep, herded by the leadership of the NHS.  They don't even bleat in protest of this kind of failure.  No US hospital would survive the aftermath of a failure like this - except one run by the government....

The Pen is Mightier than the Computer

    When it comes to Computerized Health Information Technology (CHIT), also known as the Electronic Medical Record (EMR), the pen is mightier than the computer.

    Why? Because regulators and billing professionals seek comprehensive documentation, and believe that more information generates a clearer, more useful picture of what is happening (and has happened to) a particular patient. Malpractice attorneys and quality experts lust for this level of detail, as it will afford them the opportunity to point out the myriad failings of the health care system, and serve as a perch from which they can direct the continuous improvement in the quality of care. Patients, anxious that critical elements of their medical story might be lost or unappreciated, are anxious that every caregiver have complete and total awareness of the details and trajectory of their medical history. While noble, this aspiration is part of the problem with CHIT, and perhaps the major obstacle to its being a solution to any problem in medicine.

    The relentless quest for higher resolution of detail has driven a relentless increase in the detail provided.  Unfortunately, the coding available is often a poor fit for the clinical information (a mild dilation of the aorta classifies out as an aortic aneurysm, the former something that bears minding over decades, the later a potentially life threatening medical problem that commands close follow-up).  Worse, much of this coding is generated by administrators remote from the bedside, and who typically are deprived of the information required to code accurately.  The imperative to code something, anything, invariably trumps accuracy, and little inaccuracies creep in to the documentation in droves at this point.  Please note the shift in language from record to documentation in the last sentence.  Only outsiders regard such documentation as containing useful information about a patient; you will likely never meet a healthcare provider who has this view.  You will never hear ‘Could you please request Mr H’s medical and billing records from his hospitalization at memorial hospital?’ Not gonna happen. In fact, practitioners know that there is more noise than information in this documentation, which is why they do not and have never had any interest in it.  It is almost certainly the case that the cost of improving the accuracy of this documentation far surpasses any benefit that might accrue to the patient.  The fantasy that you can monitor the quality of health care from this perch, or improve it, is, well, a fantasy.  This has not stopped major players from falling for this, hook, line, and sinker:

http://www.boston.com/news/nation/washington/articles/2009/04/13/electronic_health_records_raise_doubt/?page=full
(this is a news story of how the incorporation of such billing information completely corrupted a Google medical record).

    Many EMRs read like Madlibs(for those of you old enough to remember what they are), because they are in fact cut-and-pasted snippets of data from other parts of the EMR, put in place to fulfill some billing documentation requirement or some regulatory imperative. Free text annotation is often discouraged, and  frequently impossible to juxtapose next to the appropriate snippet of information in the chart.  Some systems make it very difficult to generate any kind of free form documentation, and consequently critical events in the course of a hospitalization are never documented.  In most or all hospitals, practitioners have developed a shadow chart that incorporates all of the critical information that practitioners need to know to care for a patient.  The existence of these shadow charts has been driven by the hijacking of the medical record for billing and regulatory purposes.  The creation of these charts represents additional effort for everyone who directly participates in the care of patients.  That such busy people are willing to do this is striking.  Little you want to know is in the chart; everything you need to know is in the shadow chart.

http://content.nejm.org/cgi/content/full/358/16/1656
(this is a nice piece from the NEJM about the pitfalls & failures of the current crop of EMRs.  The authors describe the practitioner driven to keeping note-cards on his patients)

http://ukpmc.ac.uk/articlerender.cgi?artid=1023477
(this is a manuscript about sign-out sheets – the most common form of shadow chart – I am a co-author).

    Why is the pen mightier than the EMR? Before the modern era, the chart contained whatever information practitioners caring for the patient thought would be useful to others, either at present, or in the future for review.  Writing with a pen is effortful and time consuming. It forces the writer to abstract and extract critical information, and to synthesize whenever and wherever possible. Information is only duplicated if it is essential to the story that is being told.  The pen permits the writer to organize a note as they see fit, incorporating information wherever it makes sense to them.  If a picture saves a thousand words, then a sketch is likely to be incorporated into the note. Notations in the medical record call the readers attention to what the writer thinks is important and why it is deemed so.  The exclusion of extraneous information is as critical as the inclusion of crucial information.  Charts that are a concatenation of such notes are exceptionally useful in telling the stories of patients, but are a thing of the past (sadly, an increasingly remote past).  I have an ICU colleague who writes 3-7 sentence notes about patients.  His notes are as brilliant as they are concise, and everyone who reads them admires them, and envies his ability. In almost every instance, his notes are the only thing worth reading in the chart. While such brevity is possible with the EMR, it is not cultivated by it. Worse, synthesize seems to be an unnecessary undertaking whose execution is poorly supported by the EMRs of the present.

    How will we know an effective EMR when we see one? Easy.  The story of the patient will not merely discoverable, but self-evident.  Practitioners will cease making shadow-charts, because they will no longer be worth the effort.  Stalinist regulation to compel this might create the appearance of success, but only in the minds of the regulators and administrators who generated it.  Sharp end practitioners would be profoundly hampered by any such mandate.  Indeed, any regulation at all of shadow medical records is likely to significantly hamper medical care, which is why almost no one studies them, and why there is little or no discussion of them outside of the community of practitioners.

    The fantasy is that the chart is the repository of all of the facts of a patients care.  The reality is that the chart should tell the story of a patient’s care, clearly and concisely.  Anyone who reads it should come away with the patient’s story, not a mountain of seemingly vaguely related facts, as is the case with the EMRs of  today.  The pen promotes this, the EMR of the present actively obstructs it. For now, the pen is indeed mightier than the EMR.

An article about CHIT that everyone should read!

The article here:

http://medicaleconomics.modernmedicine.com/memag/article/articleDetail.jsp?id=590411&pageID=1&sk=&date=

highlights several important problems with the electronic medical record.
- Cutting and pasting is easy, writing is hard.  Hence EMRs are filled with mountains ofduplicate information, and almost nothing about what happened to a patient, or why.  The article intimates that a single 3x5 card might contain more useful information about a patient than megabytes of EMR.
- Rather than improving practitioners ability to withstand audits,they may create a circumstance where it is dificult or impossible for a practitioner to survive one.  The article points out that required documentation and coding may not be supported by individual systems (this will require constant updating). The absolute lack of concordance between documentation and effort severs a long established assumption: that extensive documentation reflects extensive contact and participation.

Stay tuned for further details!

Update on CHIT

Since my last post on CHIT, the economic stimulus package has been passed, and includes on the order of $20 billion to support the development of electronic medical records.  A few observations:

- The UK had a nationalized health care system, with standardization at many levels, for decades before it embarked upon its still floundering efforts to create an electronic medical record.  The amount budgeted is far less than what the UK has spent thus far.  The population of the US is several times larger than the UK, our health care system is nearly completely decentralized, and there is little standardization outside of health care directly provided by the US government.  It is likely that several times this amount would be required to arrive at the same point as the British – which is close to nowhere.  In short, the amount allocated is not even close to enough to begin to deal with the US problem, let alone craft any functioning product.  If the US experience replicates the UK experience, then the amount of money budgeted is far, far short of what will be required. 

- How is this money to be spent? This is not a trivial question, but in fact a central question.  There are major vendors of CHIT in the US, but their business model is of proprietary software and databases.  The kind of portability and accessibility that proponents of the EMR (Electronic Medical Records) tout are anathema to the business models of these vendors. Are the feds to choose one (and compel the scrapping of the competitors)? If history has taught us anything, it is government granted monopoly to any private corporation is a prescription for delay, cost overrun, inefficiency, and corruption.  Are the Feds to start from scratch? Are they to stipulate some sort of standard? Either would have the effect of undoing a substantial percentage of the experience and investment in systems to date.

- Can we even find efficient use for the money that has been allocated? Quite seriously, no one has ever had this kind of money to spend on the development of an EMR before. We’re clearly not ready to commence production, and we may not even know where we are in development.  Can there possibly be enough researchers and developers to efficiently and effectively utilize $20 billion dollars in funding?  The most likely answer? Somewhere between doubtful and inconceivable.  Make no mistake: the funds at issue will generate a huge number of ‘instant experts’ and draw everyone with remotely relevant experience into the endeavor. Sadly, there is no one with a large scale success to be recruited, because no one has had success on a large scale.

It's All CHIT To Me

There is enormous enthusiasm for Clinical Health Information Technology both from within health care and from the outside as well. There is enormous enthusiasm for provide rapid access to information about patients, with widespread belief that such systems will improve the quality of care and the satisfaction of both patients and providers.  There is no question that, on a small scale, such systems can work, and work extremely well. For instance, my own direct experience with my own department's pre-op clinic software, designed and developed by a clinician, was simply phenomenal. Satisfaction with locally developed systems is generally quite high.  More broadly, the larger the scale, the lower the performance and satisfaction. 

Our new administration is calling for increased utilization of CHIT at the national scale, and seems poised to spend a substantial amount of money for this purpose.  Once again, it makes sense to evaluate the English experience. The results are not encouraging. Worse, the bad news does not seem to have traveled well across the Atlantic.  My colleague Richard Cook has been following this story for some time, and you can read his bog posting about it here:

U.K. NHS computer system on verge of collapse & implications for the U.S investment in CHIT

There is also an interesting article, forwarded to me by  him, here:

http://business.timesonline.co.uk/tol/business/industry_sectors/technology/article5636437.ece

His other posts on the subject in the RIsks forums are also very much worth reading:

http://catless.ncl.ac.uk/Risks/25.44.html

This one is both erudite and humorous:

http://catless.ncl.ac.uk/Risks/23.81.html#subj6.1

Like so many things in health care, it is far easier to get this woefully wrong than most outsiders appreciate. As importantly, the financial costs of these failures are staggering.  The vast majority of CHIT systems in use or under development today have cost far, far more than projected, and taken far longer to go-live than their proponents represented.  Put differently, I am not aware of any system that was completed on time and under budget. 

In 2002, Cedars-Sinai in LA tried to bring up an electronic medical record. A caregiver revolt forced them off-line, back into the functional world of paper and pen.

Here is follow-up from the Cedars-Sinai implosion from years ago:

http://www.washingtonpost.com/wp-dyn/articles/A52384-2005Mar20.html

And finally, even when you go live with such systems, you confront potentially insuperable security and privacy problems:

http://www.latimes.com/news/local/la-me-cedars-sinai23-2008dec23,0,6381180.story

http://www.consumeraffairs.com/news04/2006/05/va_laptop.html

Be certain: in this, the electronic world mirrors the real world: security and easy access/ease--of-use struggle to co-exist.  Secure systems will be painful to their users, and easy to use systems will be riddled with security vulnerabilities.

Merry BIS-mess to you!

So. Plenty of oxygen was consumed discussing/arguing/debating the merits of the secret-recipe Aspect BIS cerebral monitor at this year's ASA. Isn't this getting old? First, my disclosures. I have no financial interest in or support from Aspect medical (in fact, given the state of the economy, I have no financial interest or support from anything, aside from my ever-shrinking clinical income.) Second, I use the BIS every day, on almost every case I do longer than 15 minutes, paralyzed or not. I even use it on most functional (awake) craniotomies. I have been known to shave the occiput in order to place a BIS array for ACOM aneurysm clippings (yup, we still do them here, now and then). I liiike it. I've used it at least a thousand times.

But it does have its limitations. Like last month, when a young lumbar patient on 2% Sevo and fent with a reading of  42 "BIStles" (that's what I call 'em-why not?) in one epoch, did his best unconscious imitation of upward facing dog the next... (yes Ira, I know-the brain is not the spinal cord.) Do a hundred BIS cases without paralysis and you'll understand in your gut what I mean. But I still like it.

As monitors go, in my practice, the BIS is worth about 1 pulse-ox units (pou). By comparison, the gold standard monitor, the pulse-ox is a perfect 10 pou's.  The Pulse ox is the most perfect anesthesia monitor that ever was, or could be (anybody besides me old enough to remember that feeling in your gut upon hearing a surgeon say "the blood looks dark"?)  Blood pressure, maybe 7 or 8 pou's. Gas monitor, about a 6. The ECG, 2 or 3. This score is obviously my subjective weighting of the sensitivity and specificity of each monitor for keeping my patients (and me) out of trouble, and can certainly vary based upon each individual patient's specific situation (for instance, a person with a history of SVT intuitively derives much more utility from intraop ecg monitoring than a fit 20 something, in whom the ecg almost never tells me anything  I don't know from the plethysmograph.)

Big Brother: Coming Soon to a Hospital Near You!

A prevailing belief in the modern world of health care is that outcomes would be a lot better if people would just do what the best-evidence dictates. In clinical practice, best evidence is incarnate in guidelines and protocols generated by societies, associations, and various empowered committees in hospitals and health care organizations. Concerns about conflicting outcomes in the clinical literature, the extension of the results from the study population to patients in general, and whether the cost of the program is worth the payoff are all safely classified as reactionary obstructionism by the leaders of this revolution. Pay 4 Performance was sold as a way to reward those who conform to ‘best practice.’ While it continues to have advocates, sharp-end practitioners have collectively come to the realization that P4P is a hoax intended to further reduce payments (mostly government) to health care providers.

http://docsurg.blogspot.com/2008/07/oops-p4p-slip-is-showing.html

It is already the subject of caustic irony, published in top-shelf peer reviewed journals:

http://jama.ama-assn.org/cgi/content/full/300/3/255

Finally, it is a dark day when Dilbert is smack-on about the world of health care:

http://www.dilbert.com/strips/comic/2008-09-03/

Where does all of this leave us? Well, at the highest levels, the backers of best-practice believe that the problem is that we have not gone far enough. Like the British generals prior to the Somme, their belief is that success requires the same template executed on a larger scale. In this instance, the belief is that practitioners routinely ignore best practice, in spite of whatever the documentation they generate might represent. Hence the only way to verify what happened is to create an enduring, reviewable record.

http://www.arrowsight.com/public/as/html/Medical/videos.asp

While the vendor appears to be marketing comprehensive systematic nearly prospective review; in reality such evaluations are certain to be extraordinarily expensive. Worse, performing them on a large scale would require an enormous number of hours, which would only be affordable if the work was done by less-skilled reviewers, or exported ‘off-shore.’ Realistically, this record will be used to ‘look back’ and determine the causes of bad outcomes. Do those who will be using this system for this purpose possess the necessary expertise (e.g. training as the NTSB would require)? I am unaware of any evidence to support this assertion; in fact, I would be flabbergasted if this was the case. Even in their infomercial, it is clear that they are focused on ‘Who are the bad actors?’ rather than ‘Why aren’t these practitioners doing what we want?’ This is not a trivial distinction; it is the difference between mindless, punitive inspection and actually the kind of human factors analysis necessary to improve performance (see The Inspections Will Continue…..). Woe to the ‘bad practitioner,’ this technology provides a mechanism to acquire evidence and levy sanctions.

Beware the briar patch. While many hospital administrators thirst for information this detailed, most do not realize that it could consume all of their time, and generate liability on a scale that they previously have not encountered. Some observations for health care organizations that are contemplating purchasing this technology:
1. If you don’t sanction practitioners for failure to comply, you’ll have to justify that decision. If you apply sanctions appropriately, there may be no one to do the work.
2. If practitioners comply with all applicable regulations and guidelines, economic failure is certain in any but the most lucrative practice environments. Nothing will get done.
3. Conflicting guidance will create organizational conflict. Where guidelines conflict, practitioners will either act in accord with their best judgment, or worse, compel institutions to generate guidance. This technology requires the organization to have an opinion about best-practice in every domain.
4. Legally, the enforcer assumes all of the risk. Plaintiff’s attorneys will love this: it makes the hospital/clinic accountable for every action of every practitioner. There will be no excuses for either not knowing or not acting.
5. The ‘rules’ you enforce had better be defensible in the face of litigation and continuously up-to-date. Every single one is likely to be tested in the courts.

Of this I am certain: this technology will be a weapon to silence counter-revolutionaries and reactionaries.

This post was written by Mike O'Connor

Cardiac Transplantation Following DCD Should Be An Oxymoron...

"Cardiac Transplantation following DCD should be an Oxymoron."    -Mike O'Connor.

No matter how cynical you get, it is impossible to keep up.         -Lilly Tomlin

As the saying goes, "you can't make this stuff up." This is in reference, of course, to the recent NEJOM article entitled Pediatric Heart Transplantation after Declaration of Cardiocirculatory Death. In this study, two infants had their hearts harvested following 75 seconds of asystole. The very first post of this blog was titled with a Thoreau quote; "Distrust any enterprise which requires new Clothes." That might be aptly rephrased in the present instance to "Distrust any behaviors which require new ethical language." Obviously, here, Donation after Cardiac Death would be a misnomer, since the heart is nothing like dead, so the designation has been quietly and not-so-subtly modified to cardio-circulatory death. This seems like a further slippery step along the path to a utilitarian transformation of the ethical calculus of donation. Initially, when Beecher et al advanced the definition of brain death, the inevitability of corporal death was a given. Then, in response to a shortage of organs, the line was moved to allow the hastening of death through Donation after cardiac death. Make no mistake, this new designation of cardio-circulatory death, and its ethical rationale represents a fundamental shift again, towards a paradigm of "relative" utility; the implicit argument is that the recipient can make better use of the organ than the donor. This all takes place under the cover of compact between the donor's guardian, the recipient, and the intermediary technicians (transplant surgeon, etc.)

The Inspections Will Continue Until the Quality Improves...

Not-so-long ago, on this continent, one of us was Chief of Staff at a local Columbia Hospital when the Joint Commission for Accreditation of Hospitals (JCAHO or here, JC) appeared for a scheduled survey. Surveys were a little different then; they were announced long in advance, and, if a hospital did exceptionally well, they would receive accreditation with commendation; sort of a gold star. RFI's (recommendation for Improvement) were called  "Type 1" recommendations, and were taken as show-stoppers by all parties, requiring follow-up to ensure correction/compliance. Enough Type 1s and you lost your accreditation, which meant financial ruin. At that time, the Columbia hospital chain owned over 300 hospitals, and had convinced the Joint Commission that their operating practices were so different from other hospitals that they needed their own dedicated surveyors. During the inspection at issue, the physician on that surveying team insisted on a type 1 recommendation based upon his sense that medical staff leadership was marginalized by administration (or some such- the actual wording was never shared with the clinicians). Subsequently, administration announced that this type 1 recommendation had been "rescinded" and that the hospital had received "Accreditation with Commendation." Rumor circulated that said physician was henceforth dis-invited from surveying Columbia hospitals...

The JC was once a consensus building organization that followed the lead of its subscribers and accomplished a great deal. When Congress conveyed "Shall Deem" authority for medicare certification upon the JC, it wrested control of the JC from it’s subscribers and transformed it into a regulatory limb of congress and CMS. While the JC is undeniably under the direction of honorable people, their efforts have become distorted by the politics of money and power which surround them. It's no secret around hospitals that practitioners see no connection between the Joint Commission process and quality of care. Indeed, every practitioner understands that some of the worst hospitals attain JC accreditation almost effortlessly, while some of the best struggle to maintain their certification. Historically, JC inspection was centered on physical plant and policy/procedure. Dreadful care was fine, as long as the policy and procedure manual was up to date and concordant with the most recent guidance. Joint Commission accreditation was, and is, a high stakes game, and unfavorable decisions are very likely to be contested in court (or with the threat of litigation). Consequently, JC regulatory activity has progressively focused on inspection activities that can withstand such litigation. This trajectory has relentlessly uncoupled Joint Commission inspection and accreditation from even a remote relationship to quality of clinical care.  High scores and necessary accreditation have become contingent upon putting up a temporary facade of strict compliance, which frequently obstructs, rather than enhances, care. For the past two decades, the closest thing to a Potemkin village in the American culture has been a hospital preparing for a JC survey.

Medical Idiocracy

Medical Idiocracy*

 

The following was inspired by the presentation of the ASA president and the SAB plenary session at this year’s AUA meeting. It is reprinted  from the  Summer 2008  AUA newsletter.  http://www.auahq.org/Summer2008.pdf

  

 

What a trip! An hour ago I entered the UPenn hyperbaric chamber but there was a power surge and poof! The lights went out, the barometric pressure undulated up down and all over and I found myself in the chamber after the lights came on but different folks were running the unit. I looked at the clock and it was the year 2050! I stepped out to find the tech frantically turning knobs and spinning wheels and trying to figure out what was going on. He did not seem very able as a problem solver.

(The hyperbaric technical society, founded in 2010 and following the lead of the nurses, successfully lobbied and got a law passed in 2020, giving the techs full autonomy to run hyperbaric chambers. The PhD’s all were released. In a repeat of the scenario that occurred with the 20^th century steelworkers, most enrolled in nursing school as a pathway to a remunerative, satisfying, autonomous career.  Notably, the Journal of Hyperbaric Medicine, receiving an insufficient number of submissions, stopped publishing in 2031.)

Wow! I thought. Its 2050! I couldn’t wait to find out how Anesthesiology had progressed and was eager to check this out. So I ran over to the hospital, now called UPMC-HUP (yes…..UPMC bought the UPenn Health system in 2025) to check things out. I really wanted to observe things in my old neuro rooms.

The neurosurgery advances were just magnificent. The robot worked wonders and all the guess work was gone. The UNIX-versant neurosurgeon put the patient in pins, programmed the computer, and was able to oversee six craniotomies at once.  Very cool. But the anesthesia…..the anesthesia was a different matter.

(The many patient safety efforts of visionary MDA’s that started in the mid 20^th century progressed through the first two decades of the 21^st century. The APSF’s work continued with 50 research grants annually, over 60 patient safety standards in effect, and over 100 instructional patient safety oriented videos in use by 2020. Anesthetic death and morbidity was approaching zero. However, The AANA, after a persistent and brilliant lobbying campaign,  got a law passed in 2015 which allowed them to practice independently while concomitantly increasing the number of CRNA and PhD-level CRNA graduates…all according to their secret strategic plan laid out in 2001 and implemented with little resistance from the highly paid, overworked,  and otherwise complacent MDA’s of the early 21^st century. The law specifically allowed PhD level CRNAs to present to patients as their anesthesiologist and their anesthesia doctor. In addition, over the next five years,  in the context of a catastrophic health care funding crisis with rampant systemic rationing of resources,   the AANA brilliantly and  effectively argued that each SRNA was self-funded and MDA’s were overpaid with no added value, given the spectacular safety record of anesthesia. Moreover, they convinced the legislators that it would be in society’s interest to stop funding all MDA anesthesiology residencies.  The federal health care act of 2020 provided for no funding for MDA training while abolishing anesthesia-related lawsuits.  This contributed to the spectacular growth of SRNA residencies over 2020-30. Third world health care, already dreadful, became a calamity as nurses from those countries flocked to the USA to take the newly vacated, well compensated bedside nursing jobs.)

So, my old anesthesia department, august tradition of Dripps, Eckenhoff, and VanDam notwithstanding, was phased out of the medical school in 2030 and now the CRNA PhD’s were running the anesthesia service line.  I must admit they ran an efficient operation. Everyone got propofol, vec, and desflurane. All got the same airway management and most of the patients that I saw woke up just fine.  I was told there was the occasional stroke and the occasional cardiac arrest and post op MI, and sometimes there was an difficult airway related death. In fact the anesthesia death rate had risen since 2008 and those who did not do well in surgery had a financially mandated withdrawal of support. Things like this were necessary in a world with more beneficiaries than workers; it seemed like these negatives were acceptable cost benefit trade offs in order to keep the federal health service running. Other than that it was just like 2008, but with shorter turnover times.

I found one of these latter day anesthesia doctors so I could have a discussion about what was going on. I was eager to hear about how the nascent issues of 2008 neuroanesthesia had grown. So I asked, what had happened to developments in genomics to tailor anesthesia? What about the new brain protection strategies? Had the new laser IR to support brain ATP been translated? Surely that was in use by neuroanesthesiologists of 2050. What new drugs had been developed? How about blood substitutes? Any new monitors? Any continuous CBF and CMRO2 monitors that were being discussed in 2008?  New simulation technology?  Had anything changed since 2008?

The anesthesia doctor I spoke with looked askance at me and suggested that there were no significant problems, the surgeons had solved all the important problems and all the stuff I was asking about, after review by the Best Practices Board of the AANA, had been dropped as just expensive  fluff stuff. They were doing just fine without it.

So after a week or so in 2050, I headed back to the chamber and hoped the “hey dude” gang could get me back to 2008. 

 

 

Story line adapted from the new cult movie, “Idiocracy” If you’ve never heard of it learn more from http://www.imdb.com/title/tt0387808/ or http://en.wikipedia.org/wiki/Idiocracy or just google it.

 

Evil Humors

Like most practitioners, I find myself attending M&M conferences at least 26 times a year.  In my department, these are simply terrific conferences: well planned, meticulously researched, outstanding presentations.  In most instances, I find that I would do as those presenting did.   That is to say, I cannot see any reasonable way of foreseeing or avoiding the bad outcome being discussed, and am not retiring in making this known.  This frustrates some who hope to actively evolve our practice, especially those who view themselves as leaders in the application of evidence to our clinical practice.

So there I was at M&M, listening to a discussion of a case, when a colleague pronounced ‘I know what happened’.  This happens with astonishing regularity.  I listened attentively.  The commentator was far more certain of what had happened and why than was even remotely possible. Confabulation or rationalization? God only knows. 

Throughout the history of medicine, we have continuously believed we have a complete understanding of the biology that underlies the vast majority of the diseases that we encounter.  Whether it is earth elements, evil humors, histamine, prostaglandins, cytokines, NO, genomics, or small RNA; we have never lacked plausible and attractive explanations for the phenomena we sought to understand.  Never.  History continuously proves us and our paradigms wrong.

Once upon a time, syphilis was widely understood to be the great imitator.  If you wave your hands long enough and hard enough, you can use syphilis to explain anything.

We have now identified many syndromes and diseases based on improved understanding of their biology, improved imaging, and improved diagnostic testing. Anaphylaxis? Prion disease? Catastrophic APLA? Schizophrenia? Carcinoid? Serotonin syndrome? Touret’s? Minamata disease? Sarcoid? Ulcerative colitis? Thyrotoxicosis? Lupus? Systemic sclerosis? Consumption? Hoards of others? All of them have been out there forever in one form or another.  All syphilis.

Once upon a time, esophageal intubation was allegedly common.  What about Suxx – K  burns? MH? Carcinoid? Pheo? Latex allergy? Serotonin syndromes? Anaphlaxis to vehicle? Anaphylaxis to NMB? Anaphylactoid reactions(Red Man  Syndrome)? Bacterial contamination of drugs? Posterior Ischemic Optic Neuropathy?  Who knows what else?  All of them were out there.  My guess is that events associated with these were tied back to ‘esophageal intubation.’  The world was overflowing with people who ‘ knew what happened’.  In most instances, our explanations were complete rubbish – rationalizations framed in the context of what we believed was a robust and complete understanding. It is only in retrospect that we can see with excruciating clarity how profoundly wrong our explications were. In most instances, invoking ‘evil humors’ would have been less wrong than most of the explanations offered.

Even now, the temptation to explain that which we do not understand utilizing frameworks(paradigms) we believe are complete and robust is insuperable.  A colleague, someone whom I have enormous respect for, once told me that he truly believed that cardiac arrest during neuraxial anesthesia arose from inadequate vigilance.  This, in spite of years of event investigations which refute it as even remotely plausible.  Whatever it is that causes these tragedies, this much is certain: it isn’t a lack of vigilance (at least not in most of the cases).

"To see what is in front of one's nose needs a constant struggle." - George Orwell

Our hubris is also a source of tragedy over time.  For example, it is now widely accepted that intrapartum asphyxia is the cause of no more than 10% of the cases of cerebral palsy in our world.  The remainder, that is to say the vast majority, seem to be caused by some combination of intrauterine infection and the demise of an intrauterine twin; both of which precede delivery by weeks to months.  Given this, it is unsurprising that escalating monitoring and aggressiveness in the management of fetal hypoxia had no effect on the overall incidence of cerebral palsy.  In retrospect, the absolute inability to make any forward progress on this problem should have made it obvious: the vast majority of CP is not caused by intrapartum asphyxia.  Once again, an invocation of ‘evil humors’ would have been less wrong than the conventional wisdom.  No matter, like the British at the Somme, more resources were pushed forward to deal with the failure.  More policy.  More protocol.  More regulation.  More nurses. Higher tech monitors.  More aggressive management of fetal distress.  All for nought.  How many times did someone at M&M utter ‘I know what happened.’?  Who are the casualties here? Not just the patients.  How many doctors and nurses were devastated by the idea that they might have caused CP in a child? How many careers were ruined? How many millions of dollars were paid for events that were beyond the power of those held responsible? Who is going to apologize to those practitioners? Who is going to pay them back?  Who is going to make it right?  (The answer to the last three: No one.)

As an educator, one of my greatest responsibilities is this: to convey to my students, residents, and fellows an appropriate degree of circumspection regarding the limits of our knowledge and understanding.

‘I know what happened.’ Bullshit.

One of the wisest men I have ever met says: ‘ I don’t know what it was, but whatever it was, it was the worst case of it I ever saw.’

As for me, I know: it’s syphilis.

Wondering

I was just wondering:

Everyone knows that there have been significant problems with quality control in the manufacture of heparin, especially in foreign plants (be certain: there have been problems in the past with US manufacture as well).

I am the only person who wonders whether the epidemic of HIT for the past decade or so might be in part a consequence of lax quality control in the manufacture of heparin? Will it subside with additional scrutiny of its' manufacturing?

Answers:

Almost certainly not.

Maybe.

Its not continuous quality improvement, its CQD

Or…..we have to eat too!

 

 I herewith recite some of the teachings of my erstwhile teacher and career-long colleague, Mike Rie, now of the University  of  Kentucky  and paraphrase an abstract we presented at ASA in 2003 called:

 

“Pareto Economics: Research Ethics And Law Violations In Interventional Continuous Quality Improvement (CQI) Reports”

Recent reports offer examples of efficiency driven non therapeutic CQI projects in Anesthesia and Critical Care (1,2,3). These reports describe innovations in process designed to conserve resources but with no intent to improve the outcomes of the patients involved in the reports.  I expect those health care providers  involved in implementing these processes did not conceptualize that they were involved in the involuntary taking of quality from the involved patients…. kind of like eminent domain when they take your house for the new highway (or shopping center). This is actually a medical form of Pareto economics.

This conservation and reallocation of resources assumes that the Pareto Improvements (4,5,6) in an economic system depicted in the figure  are both ethical and legal in health care process innovation notwithstanding the constitutional protections when it comes to eminent domain.

Pareto Economics. In an economic system a Pareto improvement occurs if a person made better off can compensate a person potentially worse off such that resources remain after such compensation. This is used to lawfully justify public policy of building roads. If a property must be taken by eminent domain to promote the public good, the American Constitution provides that just compensation must be provided. As everyone knows this taking of property certainly involves awareness of the “takee” with a due process recourse. Too bad the  patients suffering involuntary taking of quality are seldom aware and have little recourse for appeal or for compensation. This leads to the notion that not CQI but CQD is the process of our time… a time wherein health care costs are predicted to double. That will never happen. After all as a society, we have to eat, provide for the common defense, and make sure our CEOs are well fed.

 Continuous Quality Decrement (CQD) Activities. Industrial CQI methods have been widely incorporated into health care and assume, for the overall good, that a small decrease of costly health care at point B (figure) can be permissibly redistributed to point A. This application of Pareto economics, usually implicit, underlies the managed care assertion that enhancing preventive services safely permits and justifies decreased budgetary allocations to expensive services like anesthesia and critical care. This assumes that a small (even if difficult to measure) decrement in quality at B is universally acceptable to those patients at B (or that they would voluntarily accept economic recompense) so as to enhance preventive benefits to patient populations situated at point A. However, this Pareto trade off in health care has been ethically rejected in theory and by two prominent medical consensus task forces (4,5,6). The a priori prediction that a small diminution in quality to some patients at point B is acceptable represents an untested population-based research hypothesis and imposition of an operational moral value to patient care

 Recent American case law suggests that the Nuremberg Code of Ethics may now be legally applicable, requiring changes in patient populations disclosure of interventional CQI with accountability to IRBs (7,8,9) or perhaps others sorts of ethical oversight. Given that these patients who suffered involuntary CQD with no prospect of improved outcome and clear risk of injury, one must wonder when this will be used as a legal theory buttressing successful litigation that will change our style of treating patients like widgets.
Conclusion. The creation of undisclosed Pareto trade offs in health care clash with individual rights to previously agreed upon contractual services in medical care and may constitute unethical and illegal human experimentation. For maintenance of professional integrity and public confidence in the medical profession, medical organizations should begin public disclosure of the CQD decisions that are undertaken in our clinical practices. In addition, editorial boards of peer-reviewed journals should review their policies concerning ethical review of CQI/CQD type interventional reports

 

References.

1. Anesthesiology 91:83947,1999

2. Anesth Analg 96:1104-8,2003

3. J Trauma 46:6259, 1999

4. J Health Econ16:131,1997

5. JAMA 276:11727,1996

6. Am J Respir Crit Care Med 165:54050,2002

7. Grimes v Kennedy Krieger Institute: Md Ct
of Appeals 366 MD.29, 782 A.2d 807;

8. Crit Care Med 31(suppl):S143-52,2003

9. Curr Opin Crit Care 3:329-33,1997

 

Donation after Cardiac Death: Is mostly dead slightly alive?

"There's a big difference between mostly dead and all dead. Now, mostly dead ... is slightly alive."

-Miracle Max, The Princess Bride.(1)

In Jainism, a gentle devout sect of Hinduism, the sanctity of life is taken to an extreme. Jains are vegetarians. The most devout Jains will not eat fruits and vegetables that are harvested; they prefer to eat produce that has fallen naturally from the vine or tree.

Which brings us to the euphemistic "Donation after Cardiac Death," or DCD. For those of you who have wandered into this blog, a little history. In 1968 a Harvard committee headed by Henry Knowles Beecher (Harvard Professor of anesthesiology) defined Brain Death. This led naturally to the notion that with proper consent, the organs from such unfortunate ex-individuals (individuality being lost once the person died) could be of utility to society and potential organ recipients. These potential donors are the poor folks who have fallen off the vine of life, but for whom some organs still possess vitality. But, there were problems, the main one being that as the industry advanced, there just weren't enough organs to meet the burgeoning demand.

So, the transplant industry, with transplant surgeons and organ procurement organizations (OPOs) in the lead, set aside decades of careful philosophical and ethical reasoning behind brain death in favor of a utilitarian formulation; they lowered the bar for donation...