Thursday, September 26, 2013

Vested Interests and Their Influence on Physicians- New Understanding from Cognitive and Social Psychology

Evidence-based medicine proposes patient care decisions based on the best evidence from critically reviewed clinical research, knowledge of biology and the biopsychosocial context, and patients' values and preferences.  Yet physicians often fail to make evidence-based decisions, despite many efforts to educate, or incentivize them to do so.  We used to think that the main reason was physicians' lack of knowledge and understanding of EBM, and human cognitive limitations that make such evidence-based thinking difficult.  However, now we realize that physicians are deluged by  attempts to influence their decisions so as to favor vested interests, whether or not that is good for patients.

We have discussed various kinds of deception used in marketing meant to increase physicians' prescriptions for drugs, and recommendations for devices and health care services.  Physicians have not proved to be very resistant to these methods.

Now a new article provides a different perspective on how marketers use cognitive and social psychology to manipulate physicians.(1)  Sunita Sah's and Adriane Fugh-Berman's introduction stated,

Physicians often believe that a conscious commitment to ethical behavior and professionalism will protect them from industry influence.  Despite increasing concern over the extent of physician-industry relationships, physicians usually fail to recognize the nature and impact of subconscious and unintentional biases on therapeutic decision-making. Pharmaceutical and medical device companies, however, routinely demonstrate their knowledge of social psychology processes on behavior and apply these principles to their marketing. 

The article then listed a number of findings from social (and cognitive) psychology that marketers may use to their advantage on naive physicians.

Psychological Mechanisms Promoting Acceptance of Conflicts of Interest and Dubious Marketing Ploys

First, marketers may take advantage of cognitive biases and psychological mechanisms that allow physicians to accept marketing maneuvers while denying the effect of marketing on their decision making.

Confidence and Over-Confidence

People are strongly influenced by messages delivered with confidence and do not take the trouble to ascertain the accuracy of these messages if doing so requires effort or money.

I would add that many humans, including physicians, are also over-confident in the accuracy of their own judgments.  (In 1989 we showed  that physicians often were excessively confident in their judgments of patients' outcomes, in particular, about survival of critically ill patients.)(2)

Of course, marketers often state their messages with great confidence regardless of their accuracy.

So physicians need to try to restrain their own over-confidence, and be more skeptical of the confidence of others. Maybe this would just be an exercise in simple humility.

Self-Serving (or Ego) Biases

People tend to believe that the results of their decisions, or of their groups' decisions, are better than average.  This can be called the Lake Wobegon effect (from Garrison Keilor's fictional town in which all the children are above average.)

We and others have shown that physicians may be overly optimistic about the outcomes of their own (versus others') patients, or their clinical units' (versus others') outcomes, again in the context of predicting survival of critically ill patients.(3)  We have also posted about how corporate boards of directors seem to almost always think that their hired executives are better than average, at least when determining their executive compensation.

Similarly, Sah and Fugh-Berman wrote,

Physicians believe that their own prescribing behavior is unaffected by industry influence, although they concede that other physicians are susceptible to such influence.

Furthermore,

Social psychology research confirms that people have a 'bias blind spot,' namely, they are more likely to identify the existence of cognitive and motivational biases in other than in themselves.
But, as Dana and Lowenstein wrote,

It cannot both be true that most physicians are unbiased and that most other physicians are biased.


So, to put it bluntly, physicians ought to be more humble about their own ability to resist outside influences and the resulting biases. Again, some simple humility might help.

Cognitive Dissonance

Sah and Fugh-Berman pointed out that

While articulating and believing in the importance of scientific objectivity, physicians' biases to accept industry gifts create cognitive dissonance; that is, discomfort that arises from discrepancy between conflicting beliefs, or between beliefs and behaviors.

So,

Cognitive dissonance theory specifies three methods - not mutually exclusive - by which people manage or reduce dissonance.  Changing one of the dissonant beliefs, opinions or behaviors (possibly a difficult or painful process that requires sacrificing a pleasurable behavior or treasured belief); Lowering the importance of one of the discordant factors which can be accomplished by denial - forgetting or rejecting the significance of one or more of the conflicting cognitions; and adding consonant elements that resolve or lessen the dissonance (this may involve rationalizations to buffer the dissonance between conflicting cognitions.)

Physicians may use denial and rationalization to reduce cognitive dissonance caused by their concurrent desire for relationships with marketers and others with vested interests on one hand, and their professionalism and its obligation to put patients' needs first on the other hand.  Sah and Fugh-Berman cited Chimonas and colleagues,

Denial included (a) avoiding thinking about the conflict of interest; (b) rejecting the notion that industry relationships affect physician behavior, and (c) disavowing or universalizing responsibility for problems that arose from conflicts of interest ('there's always a conflict of interest...').  Rationalizations included (a) asserting techniques that would help maintain impartiality and (b) reasoning that meetings with drug reps were educational and benefited patients.

We have discussed various public justifications for accepting conflicts of interest by physicians and other health care decision makers that employed a variety of logical fallacies along these lines.

So physicians need to re-examine their treasured beliefs and the gratification they get from relationships with industry (as opposed to those with patients, colleagues, friends and families).  They could remember the advice that no one can serve two masters.

Sense of Entitlement

Physicians' sense of entitlement, especially given the increasing stress upon them, may be used to rationalize relationships with drug, device and biotechnology companies since these corporations seem to be among their few friends (versus insurance companies, government agencies, and sometimes hospital administrations whom physicians feel may be more burdensome.).  So, in one study,

Implicitly reminding physicians of the burdens of medical training and their working conditions more than doubled reported willingness to accept gifts....
So physicians need to reconsider that to which they feel entitled.  This is the third instance in which some humility might help. 

Principles of Influence Used by Marketers

Markets seem to also be well acquainted with the six principles of influence and persuasion identified by Cialdini and colleagues.

Reciprocity

The norm of reciprocity - the obligation to help those who have helped you - is one of the guiding principles of human interaction

This is the foundation of the effect of relatively small conflicts of interest, such as giving of small gifts.

Physicians pay off industry gifts through changes in their practice

Furthermore,

Gifts associated with a subtle implicit request may be more likely to achieve compliance than gifts that call for explicit reciprocation. 
So physicians need to be wary of Greeks, or anyone else bearing gifts, even those less conspicuous than wheeled horses.

Commitment and Consistence

Consistency is highly valued in our society and associated with rationality and stability.  After committing to a decision or opinion, people justify that choice or opinion by remaining consistent with it.

So marketers try to get physicians to make small commitments to leverage larger ones.  This is

why drug reps, ask, for example, 'will you try my drug on your next five patients?'
So physicians should remember there is no virtue in commitment to erroneous beliefs.  "A foolish consistency is the hobgoblin of little minds." - Ralph Waldo Emerson

Social Proof

This is basically the deliberate deployment of the logical fallacy of the appeal to common practice.

Social proof, also referred to as social validation or conformity, is the practice of deciding what to do by looking at what others are doing.

So,

If accepting industry gifts is a cultural norm in medicine, physicians will continue to do so.  The opinions of colleagues are often used by industry representatives to sway physicians to adopt a particular therapy. 

This may be why industry works so hard to sign up health care academics.

Trainees in an institution, for example, are affected by the institution's stated policies but also - and sometimes more so - by what they see their mentors do.
So physicians, who often pride themselves on independence, need to be skeptical about the need to follow the crowd.

Liking or Rapport

The more you like someone, the more you are apt to follow their advice, even if your feelings towards them have been manipulated.

This is obviously why drug representatives, for example, are so nice to physicians.

Physicians often feel overworked, underpaid, and unappreciated [ed note -  and their is plenty of evidence, some of which we have discussed on this blog, that this is not unreasonable.]  Drug reps dispense sympathy, flattery, food, gifts, services and income-enhancing opportunities and seek to ask nothing in return but scholarly consideration of the benefits of drugs.
So physicians need to reconsider who really are their friends, and be skeptical of "friends" with something to sell. 

Authority and Security

This is basically the deliberate deployment of the logical fallacy of the appeal to authority.  The best example is industry's efforts to recruit key opinion leaders, that is health professionals who are perceived as authority figures, but have really been hired to market.

From an industry perspective, the best KOLs radiate status and authority while successfully convincing their peers (and perhaps themselves) of their illusory independence and lack of bias.

Note that

KOL speakers not only influence audience members' prescribing behavior, but also - as predicted by cognitive dissonance theory - become more convinced themselves of the benefits of the products they endorse.
So physicians need to be skeptical of those claiming to be authorities, especially when they are connected with people who have something to sell.

Summary

We used to strongly believe (and Dr Wally Smith and I used to teach a course to the effect that) the major barrier to true evidence-based practice was the cognitive limitations that physicians share with all humans.  We thought in terms of cognitive biases and the inappropriate use of cognitive heuristics leading physicians to inaccurately judge the probabilities of diagnoses and medical outcomes, and thus make less than optimal decisions.

Now it seems apparent that the deliberate influencing of health professionals' judgments and decisions by external actors, mainly those interested in selling more products and services, but sometimes by those with ideological or political motives, is currently a much more important challenge to evidence based practice.  It looks like the influencers may be very knowledgeable about human cognitive limitations and how social psychology influences judgment and decisions, and may use this knowledge to pursue their vested interests, at the financial and physical expense of patients, and ultimately the public.

 True health care reform would encourage professional education designed to increase resistance to external influences that put self-interest ahead of patients' and the public's health, and careful regulation that would decrease some of the more dangerous practices used.  Of course, much more resistance might be achieved if physicians used a little more common sense when dealing with people who are obviously trying to sell them on goods, services, or ideas.  A good proportion of the deceptive methods discussed above could be countered by remembering the usefulness of humility, skepticism, and a few simple aphorisms.   

Again, as we have written repeatedly, not only should all conflicts of interest be disclosed for the sake of honesty, but physicians and other health professionals ought to consider repudiating most of all of them, maybe at some personal expense, but in the interest of re-establishing their commitment to putting the patient, not their own self-interest, or the vested interests of others, first.  
 

References

1.  Sah S, Fugh-Berman A. Physicians under the influence: social psychology and industry marketing strategies.  J Law Med Ethics 2013; 14:  . Link here:

2. Poses RM, Bekes C, Copare F, Scott WE.  The answer to "what are my chances, doctor?"  depends on whom is asked: prognostic disagreement and inaccuracy for critically ill patients.  Crit Care Med 1989; 17: 827-833.  Link here.

3. Poses RM,  McClish DK, Bekes C, Scott WE, Morley JN. Ego bias, reverse ego bias, and physicians' prognostic judgments for critically ill patients. Crit Care Med 1991; 19: 1533-1539.  Link here.

Tuesday, September 24, 2013

A Plague of Bureaucrats - Now 10 Per Physician in US Health Care

There seems to be a reasonable argument that the US health care system is more dependent on the private sector, and in particular the for-profit private sector, than systems in other developed countries.  Advocates of private, for-profit health care often tout the private sector as more efficient and less bureaucratic than government.  

However, a post by Robert Kocher in the Harvard Business Review blog, of all places, noted that US health care is increasingly inflicted by a proliferation - perhaps a plague - of bureaucrats.


Dr Kocher looked at employment of physicians, other health care professionals and clinical workers, and bureaucrats in a more recent time frame, 1990-2012.  The key findings were:

 Using data from the Bureau of Labor Statistics (BLS) and the American Medical Association, my colleagues and I found that from 1990 to 2012, the number of workers in the U.S. health system grew by nearly 75%. Nearly 95% of this growth was in non-doctor workers, and the ratio of doctors to non-doctor workers shifted from 1:14 to 1:16.

Furthermore,

 Today, for every doctor, only 6 of the 16 non-doctor workers have clinical roles, including registered nurses, allied health professionals, aides, care coordinators, and medical assistants. Surprisingly, 10 of the 16 non-doctor workers are purely administrative and management staff, receptionists and information clerks, and office clerks. 

So, in summary, for every doctor, there are 6 clinical workers (nurses, aides, etc) and 10 bureaucrats (including managers).

Note that this data appears compatible with 1983-2000 employment data we summarized in 2005. During that period, the ranks of health care managers grew much faster than the ranks of physicians or nurses.  The growth rates from 1983 to 2000 were 1.39x (39%) for physicians, 1.54x (54%) for nurses, and a whopping 8.26x (726%) for managers.

Another way to look at it is, in 1983 there was 1 manager for every 5.7 physicians and every 15.1 nurses. In 2000, there was 1 manager for every 0.96 physicians and every 2.9 nurses. Again, by 2000, the number of health care managers exceeded the number of physicians. There were more managers than any other species of health care worker other than nurses.

So, by 2000, there was one manager per doctor.  By 2012, there were 10 bureaucrats, including managers, per doctor. 

We have discussed the increasing power of managers, administrators and executives over health care.  Management gurus, such as Alain Enthoven, had advocated breaking the power of the supposed "physicians' guild" to reduce health care costs, and replacing physician leaders with managers (look here).  We have discussed the growing role of generic managers, that is leaders trained only to manage, but not experienced in , and often not sympathetic to the values of health care.  Now there is increasing evidence that managers and bureaucrats are increasingly numerous in health care, the former somewhat and the latter greatly out-numbering physicians.

We cannot scientifically prove that this plague of bureaucrats is responsible for US health care's mediocre quality and access, despite higher costs per capita than in any other developed country.  However, it does appear to be a reasonable hypothesis that increasing the relative numbers of health care professionals versus bureaucrats might produce at least more health care per dollar, if not also better health care per dollar.   

This suggests that true health care reform requires decreasing the influence of generic management.  Health care leaders ought to be those with some knowledge of health care and some sympathy for its values. Such health care leadership might be less concerned with increasing bureaucracy, and more concerned with more and better actual care of actual patients.  (But do not expect such reforms to be popular with the very well-paid generic managers who now run health care, and hence do not expect such reforms to be easy to implement.)

Monday, September 23, 2013

Should "Diagnosing While Texting" Be Illegal?

I saw an interesting comment at Medscape in the comment thread of the article "Do Your EHR Manners Turn Patients Off?" (MedScape subscription required).

Dr. [redacted] | Neurology

I live in a town that has passed legislation criminalizing texting and driving. A driver is more impaired and distracted when texting than when intoxicated.  EHR's and the practice of medicine should be no different. Do you really believe that your physician is actually concentrating on the patient in front of them while their attention is primarily focused on entering data on a computer? The reality is that EHR's true value is data collection for statistical analysis by our government and there is an obvious deficiency for enhancing the physician-patient collaborative experience.


Medicine, like driving, is a very cognition, thinking and concentration-intense activity.   Failures lead to injury and death (although not quite as dramatically in the former compared to the latter).

I think the point about distraction the commenter makes is valid, or at least worthy of healthy consideration.

Unless you're a health IT hyperenthusiast, that is (see http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html).

-- SS

Thursday, September 19, 2013

The Adventures of the Purloined Bequest, the Resident Heiress, and the Hidden Hospital System

The game is afoot again.  A series of recent articles in the media described a series of cases whose mysterious interrelationships Sherlock Holmes might have appreciated.

The Purloined Bequest

A singular article in the Wall Street Journal, entitled "Judge Rules in Case of Fortune Tied to Buffett," first made this case explicit, but some background is required to understand it.

The story focused on Long Island College Hospital, in Cobble Hill, Brooklyn, New York.  [Full disclosure: this story got my attention particularly because I grew up nearby in Brooklyn, and was born at that hospital, which was also the local hospital my parents often used.]   LICH has long been the major community hospital for downtown Brooklyn.

The story appeared to begin in 2011, per the WSJ,

 In 2011, Judge [Carolyn] Demarest approved the merger of LICH and SUNY Downstate on the condition it would keep the charitable hospital going. As part of the deal, the hospital transferred properties to Downstate estimated to be worth as much as $1 billion collectively, according to a previous court order.

The merger was supposed to keep LICH in operation as a community hospital and provider of acute care to the poor.  However, things did not work out.

 This year, however, Downstate announced plans to shut the hospital, leading to protests from Brooklyn residents and local politicians.

'It is clear that the premise upon which this Court authorized the transfer of assets has been defeated,' Justice Demarest wrote in her Aug. 20 decision, adding that Downstate had breached its contractual obligations. She cited a 'legal and moral responsibility' to correct her earlier error in approving the merger.

She directed Downstate to return all assets to the hospital's previous owner, Continuum Health Partners Inc., which subsequently said it couldn't take the reins. The court is expected to review other proposals.

The judge also discovered that hospital management had been raiding an large endowment fund intended for other purposes,


A New York state judge ruled this week that a struggling Brooklyn hospital must repay tens of millions of dollars it borrowed from an endowment set up by early investors with billionaire Warren Buffett.

The ruling aims to rectify the previous use of the money by Long Island College Hospital, which is hurting financially and was scheduled to close. Mr. Buffett in July told The Wall Street Journal that his late friends, Donald and Mildred Othmer, would have felt 'betrayed' at the way the funds were spent.



Apparently,

 The Othmers, natives of Omaha, Neb., who later lived in Brooklyn, were longtime friends of Mr. Buffett's, and each invested $25,000 with the billionaire in 1961.

When they died—he in 1995 and she in 1998—they gave away a fortune estimated at $780 million, including the $135 million permanent endowment for the hospital. The Othmer wills stipulated the interest on the endowment could be used for operating expenses but the principal should be held 'in perpetuity.'

In a series of court-approved transactions that began in 2000, the hospital borrowed from the funds repeatedly to meet short-term obligations and cover debts.

The hospital argued that the money was necessary to keep the hospital afloat, which it said the Othmers would have wanted. The transfers depleted most of the endowment, a result that came to light after the Journal wrote about the situation in July.

New York Times and Brooklyn Daily Eagle articles focused on the question of whether SUNY/ Downstate intended to close the hospital so it could sell its apparently valuable real estate assets in a now fashionable neighborhood, but not on how the hospital fell into these dire straits.


There seem to be some lingering questions -

-  If the losses and borrowing began in 2000, or earlier, who was responsible for them, given the current owners have only been in place since 2011?

Note that the phrasing in the article above ("the hospital argued that the money was necessary to keep the hospital afloat") suggested that before SUNY took over, the hospital was independent.  However, the article mentioned, albeit only briefly in passing, that the hospital had a previous owner, Continuum Health Partners Inc.

-  How were the losses explained when they occurred, and what was the rationale for  borrowing from restricted endowment as a response, instead of, for example, direct efforts to minimize losses or increase capital and revenue?

Note that the article implied that when SUNY acquired LICH, it acquired some very valuable real estate.  Why did the previous management of LICH not consider selling off some of this real estate to resolve its debts?

-  Did mismanagement of the hospital lead to excess losses, and did borrowing funds from the principle of the hospital's endowment to offset these losses amounted to more mismanagement?
 

Meanwhile, a second even more bizarre story about another New York City hospital almost simultaneously got media attention.

The Resident Heiress

The case first made it into the media in 2012, when the tabloid New York Post reported,

Beth Israel Medical Center milked reclusive copper heiress Huguette Clark for more than $13 million in fees, donations and even a priceless painting during her 20-year stay as a patient — and greedy executives angled for $125 million more, her relatives allege in shocking new court filings over Clark’s estate.

The alleged shakedown was illuminated in an e-mail in which hospital board member and former CEO Dr. Robert Newman referred to Clark as 'the biggest bucks contributing potential we’ve ever had,' according to court papers.
He told a colleague her 'potential has been overwhelming[ly] unrealized.'

At one point, he suggested to Clark that she pay nearly one-third of her estimated $400 million fortune to keep the now-shuttered Beth Israel North on the Upper East Side open so she could keep living in the room she had refused to leave for 15 years despite being in good physical health, the papers allege.

But instead of addressing Clark’s crippling anxiety, hospital honchos played on her fears, engaging in 'a concentrated effort, orchestrated at the highest board and executive levels,' to get her money, court documents obtained by The Post allege.

Clark’s death last year at age 104 set off a battle over her estate. Her distant relatives claim lawyer Wallace Bock, accountant Irving Kamsler, private-duty nurse Hadassah Peri and the Beth Israel administrators manipulated the feeble Clark for her money.

The nurse, who received cash and gifts from Clark, stands to inherit nearly $34 million and Clark’s priceless doll collection in the now-disputed will. Beth Israel is to get $1 million.

The Paris-born Clark inherited her money from her father, William, a rail and mining baron and former US senator whose wealth rivaled the Rockefellers’.

She went to Beth Israel North in 1991, when she was 85, after a doctor found her emaciated and ill in one of her three sprawling Fifth Avenue apartments.

She spent the last two decades of her life in dismal hospital rooms with the shades drawn and door shut even though there was 'no medical basis for keeping her' past the first few months, documents show.

Clark was 'the perfect patient' for the hospital, her relatives charge, noting, 'She required no medical care, possessed enormous wealth, paid over $800 a day for her room, and became progressively more dependent on the hospital.'

'Beth Israel had a plan to subtly, but ever so persistently, court Huguette for the purpose of garnering gifts and ultimately do a will in favor of the hospital,' court papers claim.

This case also seems to be about wealthy donors and hospital executives.  Yet what makes it most bizarre are the circumstance of Ms Clark's hospital stay.  As a former intern, resident, fellow, and teaching hospital attending, I can attest that most hospital administrators are concerned, if not obsessed, with discharging patients quickly.  Hospital stays are currently paid by most insurers according to the patients' diagnoses, but not their length of stay.  Long stays cost hospitals money.  Furthermore, unnecessarily long stays use up resources that could better serve acutely ill and injured patients.  Yet Ms Clark stayed an astounding 20 plus years, without any obvious medical rationale.  No hospital official contested the fact that Ms Clark stayed that long in the NY Post article.

Furthermore, in a 2013 New York Times article, the hospital's lawyer, defending a parallel attempt to recover the money donated to the hospital, wrote

 Beth Israel had provided Mrs. Clark with 'a well-attended home where she was able to live out her days in security, relative good health and comfort, and with the pleasures of human company.' Besides, he said, the amount of money she gave to Beth Israel was “not very large considering her vast wealth.”

Furthermore, a member of the Beth Israel fund-raising staff wrote in a memo disclosed during litigation,

 She was well enough by then to go home to her spacious apartment at Fifth Avenue and 72nd Street, overlooking Central Park, Ms. [Cynthia L] Cromer said, but 'she asked if she might stay in the hospital longer: she feels comfortable and safe, and her apartment is being renovated.'

Never mind that the fundamental mission of the hospital is to provide acute care for the sick and injured, not to provide comfortable retirement housing. But hospital managers are apparently on record acknowledging that the hospital was basically providing Ms Clark with services that are normally available in a retirement community, not services that acute care hospitals normally provide anyone   There is no evidence that the hospital ever provided similar services to any other patients. 

The obvious mystery, then, is

- why no one at the hospital, no doctor, nurse, or manager, or no visitor, regulator, accrediting agency, insurer ever questioned why the hospital was providing a long-term residence to a former patient?

No answer to the question has appeared in any coverage I have seen of this case, including a September, 2013,.NY Times followup article on the occasion of the case nearing trial. 

In the absence of a creditable explanation for this strange distortion of the hospital mission,

- is there any other conclusion than that its purpose was to extract a large amount of money from a vulnerable, rich, but no longer acutely ill former patient?

This would suggest an unusual but monumentally unethical kind of hospital mismanagement.

So we have two recent stories about major, unusual, apparently severe mismanagement by hospital executives.  These stories were reported as if they were independent.

However, buried in the original NY Post article, but unmentioned in either of the major NY Times articles, however, was a hint of how this case and that above of the purloined inheritance appeared to be linked.

The Hidden Hospital System

The NY Post article referred thus to the Beth Israel CEO who allegedly pushed Ms Clark for contributions,

 Newman, former CEO of Continuum Health Partners, Beth Israel’s parent organization, took the unusual step of offering to help Clark complete a will so 'some faceless bureaucrat of the government' wouldn’t get his hands on her estate, court papers say.

Quick Watson, did you see that?

Continuum Health Partners was the "parent organization" of Beth Israel Hospital during at least some of the time Ms Clark was in residence there.  Continuum Health Partners also was the "previous owner" of Long Island College Hospital during at least some of the time it apparently was suffering large losses and its endowment was being depleted.  So were both these stories really about the same organization, the same hospital system?

Digging a little further, per its own LinkedIn page,

 Continuum Health Partners, Inc. was formed in 1997 as a partnership of three venerable institutions — Beth Israel Medical Center, St. Luke's Hospital, and Roosevelt Hospital.

So while the hospital system did not exist when Ms Clark first entered Beth Israel Hospital, the heiress' "care" was under the control of the organization apparently from 1997 to the day she died.

Furthermore, as noted in a 2011 Chronicle of Higher Education article, available from Innovative Resources Group Inc,

 If there was a honeymoon after the merger of Long Island College Hospital, in Brooklyn, with Continuum Health Partners, in New York in 1998, few remember it. The bickering began early and dragged on for years, but divorce didn’t seem inevitable until the doctors went public.

So the hospital system called Continuum Health Partners took over Long Island College Hospital in 1998 and held it for 13 years.  Furthermore, apparently LICH was part of Continuum Health Partners during the time when its losses rose and the Othmer bequest was depleted.  For example, from the CHE article,

  Several physicians told a crowd gathered outside the hospital’s entrance in 2008 that Continuum had withheld money from the 150-year-old institution, needlessly cutting patient services and endangering the hospital’s future.

Also in 2008, the Brooklyn Heights Blog reported this response to a question about finances from the Continuum Health Partners CEO, Stanley Bazenoff,

 LICH faces an immediate fiscal crisis. Unless action is taken quickly, he said, LICH will not have cash on hand to meet payrolls and other current expenses. He ascribed LICH’s problem to three factors. First, the hospital carries a heavy debt burden–approximately $150 million in long-term bonds financed through the New York State Dormitory Authority and $25 million in short-term commercial paper–which results in annual debt service (including interest and amortization) cost of approximately $22 million. Second, LICH has an operating deficit, presently about $40 million on an annual basis,...

Denis Hamill, a columnist for the New York Daily News, made this accusation in a February, 2013, editorial:

Under Continuum, the once-profitable LICH ran up $300 million in debt from pure administrative malpractice. And then Brezenoff brokered the smelly SUNY Downstate merger, with state taxpayers absorbing the $300 million debt.

So it certainly looks like there is an argument that Continuum Health Partners, under its CEO, Stanley Bazenoff, was responsible for the manipulation of pseudo-patient and rich heiress Hughette Clark to secure a large donation, and the nearly simultaneous depletion of Long Island College Hospital's finances, including a large bequest that was supposed to be untouchable.

Not surprisingly, Mr Bazenoff, described by Mr Hamill as

a ruthless powerbroker ... whose nickname at LICH is Darth Vader 

and

a quintessential member of what muckraker Jack Newfield called The Permanent Government of New York  

also seems to have gotten rich in his position as leader of Continuum Health Partners, along with his other top managers.   The blog LICH Watch found these results from the system's 2009 IRS 990 report,

here are some highlights, figures for Continuum employees who, hm, earned more than a million dollars for the year:

Chandra Sen, MD, $2,109,204
Stanley Brezenoff, $2,014,413
Kathryn C. Meyer, Esq. $1,049,807
John Collura, $1,307,556
Gail Donovan, $1,365,354

 A 2011 New York Post article stated,
 Stan Brezenoff, CEO of Continuum Health Partners, overseeing such hospitals as Beth Israel, St. Luke’s and Roosevelt, pulled in about $3.5 million. 

 So this leads to yet more mysteries, first about the individual cases when viewed as occurring within one large hospital system:
-  Why were Long Island College Hospital's finances addressed as if it were an independent entity, when it was in fact just a subsidiary of Continuum Health Partners? 


-  Why was Continuum Health Partners role in the hospital's enlarging debt and depleting endowment not discussed?

Similarly,

-  Why was the bizarre treatment of Hughette Clark attributed to "Beth Israel executives," but not Continuum Health Executives, when Beth Israel was also just a subsidiary of Continuum Health? 

Then there is the larger mystery,

-  Why have these two cases been discussed as completely independent, when they appear to be part of a pattern of conduct by Continuum Health Partners management?

Summary

While we continue to see cases, some amazingly bizarre, suggesting mismanagement and unethical management of hospitals and hospital systems, there seems to be an amazing lack of curiosity about how they occurred and what their implications may be.  This lack of curiosity is so profound that no one seems to have noticed that two vivid and strange cases getting prominent media notice in the same city and the same time involved the same large hospital system. 
Health care organizations seem to become ever larger.  Such enlarging organizations can concentrate their power, dominate their "markets," and hence increase their revenues and the compensation of their top hired managers.  Without any countervailing force, they push seemingly inexorably towards oligopoly and then monopoly.
Furthermore, the cases of the purloined bequest and the resident heiress show that ever larger organizations with ever more complex structures are ever better at hiding the accountability of their top hired managers.  We have previously noted, e.g. a case in which a subsidiary of GlaxoSmithKline pleaded guilty to crimes involving production of adulterated drugs, thus shielding GSK and its management from responsibility, how subsidiaries of large corporations may plead guilty to crimes, thus absolving their parent organizations and its managers of any blame.

In the current cases, it seems that somehow a large health care system was able to avoid accountability by letting its component hospitals appear to be independent.  Yet it is the larger system that was booking the revenue and making millionaires out of its hired managers.  This seems to show how concentration of power into ever more complex organizations can be used to enhance the anechoic effect, making mismanagement and those accountable for it ever more obscure.

As we have said until blue in our collective faces, if we do not hold the real leaders of health care accountable for their actions and the actions of their organizations on their watches, we can expect continued misbehavior, and hence continued health care dysfunction.  

It's appropriate to conclude with this, a video of Jeremy Brett in A Scandal in Bohemia, from the first season of the show as first shown on PBS.



Wednesday, September 18, 2013

FDA Medical Device Regulator Resigns: Should Health IT Vendors Be Nervous? And, Do They Still Feel "Medical Informatics Not Needed Here?"

I believe HIT vendors should be getting nervous.

HIT vendors have long enjoyed a protected status and uncritical accommodation relative to other medical device industries and pharma, with contracts that gag medical professionals from disclosing defects that can mislead and cause patient harm, and that absolve the HIT vendors themselves from liability. HIT is, in fact, a virtual medical device that other important countries (e.g., in the EU) are already moving towards regulating in a manner similar to physical medical devices.

The HIT vendor "special status" may be coming to a close, and here is a sign in that direction:

Wall Street Journal
August 12, 2009
FDA Medical-Device Regulator Resigns

By ALICIA MUNDY

WASHINGTON -- The Food and Drug Administration's top medical-device regulator said Tuesday he is resigning.

The departure follows internal dissent over device-approval decisions that the regulator's critics said were too friendly to industry.

Daniel Schultz said his move comes "by mutual agreement" with FDA Commissioner Margaret Hamburg, who took office in May. [In other words, he was asked to leave - ed.]

An FDA spokesman said Dr. Schultz's decision came as the result of talks with Dr. Hamburg, and had nothing to do with any specific issue related to a device's approval process.

Drug Chief at the FDA Is Accused of Conflict

Dr. Schultz has worked at the FDA's Center for Devices and Radiological Health for 15 years and led it for the past five years.

Sen. Chuck Grassley (R., Iowa) held hearings two years ago on Dr. Schultz's approval of a nerve stimulation device to treat depression, approval that came over the objections of several FDA doctors. Mr. Grassley complained at the time that science was being ignored in favor of industry. Dr. Schultz said his decision was based on sound medical data.

In March, Sen. Grassley opened an investigation into a knee-surgery device made by ReGen Biologics Inc., after The Wall Street Journal reported that Dr. Schultz approved it over the objections of numerous FDA scientists and reviewers.

FDA Deputy Commissioner Joshua Sharfstein said in May that the agency would re-examine the approval process for the ReGen knee device to see if proper procedures were followed.

A group of nine device division employees wrote to the House Energy and Commerce Committee last October to complain that the division's leaders had approved devices despite formal safety and efficacy concerns raised by FDA. They also alleged some scientists who objected to the decisions faced retaliation from leaders of the device division. [This sounds much like the world of health IT, where whistleblowers on HIT safety may find themselves persona non grata - ed.] The FDA at the time declined to comment.

These are serious matters, and under the Obama administration I see a replacement as being far less friendly and far less likely to accommodate both physical and virtual (i.e., HIT) clinical device makers.

The irony is that Medical Informatics specialists such as myself and like minded colleagues have offered help to the HIT and medical device vendors and purchasers repeatedly over the years to improve quality of their products in a substantive, medical informatics-driven manner, and thus reduce the chances for strong government regulation.

We were repeatedly ignored, or told "we don't need medical informatics here" or equivalent, or patronized (e.g., being told by some corporate bureaucrat out of a Dilbert comic strip that "you don't have enough experience" or the equivalent in buzzword compliant corporate mumbo-jumbo. See example letter below.)

Seeing increasing risks to patients from cavalier, business IT-based approaches to HIT design, development, implementation and lifecycle, I and like minded colleagues are now using our talents to bolster the case for more robust government regulation of HIT. We feel it's well past the point of helping this industry, and protecting patients, from within.
If I were an HIT vendor used to generous accommodation of sloppy products and lack of regulatory oversight, I'd be re-examining my assumptions about the HIT business.

I will further amplify the "you don't have enough experience" issue experienced by Medical Informaticists:

** Disclaimer: The following elements in this post are about personal observations and experiences (my "narrative"), always difficult to write about without generating skepticism, and I admit possible non-objectivity in that regard. You, the reader, are free to ignore my observations:


(Click to enlarge. Example of a buzzword compliant, corporate IS "don't need medical informatics here" letter. Did its writer even read my CV?)



The above letter, from last year, has an interesting origin. I find it appropriate to write about now for reasons explained just below regarding a recent Philadelphia Inquirer report.

It is from the CIO at the hospital where I performed my medical residency and graduated with honors in the late 1980's, Abington Memorial, once
(pre-informatics postdoctoral fellowship) even fixing a broken CT scanner computer in the middle of the night when repair was not available, thus saving a young man's life. It is from the very same organization I wrote of (in anonymized form) in my Oct. 2007 post "Informaticist can't escape clinical IT issues even on personal business."

Does the letter demonstrate confusion about strategy vs. tactics vs. operations, about what Medical Informatics is and is not, and lying to justify a capricious decision not to even talk to me about a Director of Clinical Systems opening, I wonder? Was this based on CIO
political ambitions, and/or a preselected favored candidate, at the expense of physicians and patients, I also wonder? Did the CIO even read my CV? Was the almost exact same scenario at the same hospital ca. early 2000 a coincidence, or symptomatic of some other issue?Related to the typical IS department-generated "you don't have enough experience" letter above, ironically, the hospital's cardiac surgery program was recently "dinged" in quality by the Pennsylvania Health Care Cost Containment Council, as reported in the Philadelphia Inquirer on Aug. 6, 2009.

The hospital explained in the Philadelphia Inquirer that the quality variance, an apparently high death rate, was due to missing items in the information submitted to the state about the heart surgery program's patients, in a hospital with an extensive medical records system no less.


Having led the building of world-class information systems from the ground up for invasive cardiology and cardiac surgery a decade ago for one of this hospital's regional competitors, Christiana Care in nearby Delaware, against the "best" efforts towards obstructionism and mismanagement by another business computing CIO, I find this explanation heartrending (no pun intended).

As a result of my Medical Residency at Abington, I know many of the clinicians at the hospital for decades, and they are generally excellent. They saved my father's life and gave him the gift of six additional years of life, after severe malpractice in 1994 at another Philadelphia hospital - in part due to failed communication of important patient data - nearly led to his demise. Some have told me they are quite unhappy with the organization's EHR efforts.

Regrettably, the bad publicity in the Inquirer and other outlets as a result of this data irresponsibility will likely tarnish the Abington cardiac surgery program's reputation for some time to come, even if (as is likely) the high mortality rate was spurious. This was needless and avoidable.

But, of course, according to this hospital's CIO, (in essence) I didn't have enough experience for Director of Clinical Systems.

This raises a question:

Who is responsible, ultimately, for information in a hospital?

How about: the Chief Information Officer (CIO)?

Finally, I repeat, the latter elements in this post are about personal observations and experiences. I admit possible non-objectivity in that regard, although informatics colleagues in the trenches also report similar observations.

I report, you decide.

-- SS

Saving My Mother Again. EMR Problems? No, They're Merely Anecdotal; the Truth Must Be That I Attract Bad Electrons and Stale Bits

My relative, who suffered a major cerebral injury in 2010 contributed to by an EMR's interference with clinicians, fell the other day in the bathroom.

The fall was hard; she struck her back and knocked out one of the mounting posts for the bathroom tissue - completely out of the wall, the wallboard now with a large gaping hole in it.

In an elderly person, falls can result in injuries such as this one, a painful hematoma on her back.

She went to a local hospital, a suburban branch of a large one, where x-rays were done; aside from a large bruise and hematoma (collection of blood under the skin) over her back at the point of impact, miraculously nothing was broken.

At triage I went over her medication list in great detail, ensuring both the data input to the EMR and the resultant triage printout record of her meds were complete and precise. She went home.

The very next day, in mid afternoon she had sudden onset of speech difficulty (expressive aphasia) and right sided weakness, symptoms of possible loss of blood flow to the left side of the brain, while sitting in a chair talking on the phone. The aphasia was the same symptom that led to her May 2010 presentation at the parent hospital and then her travails, with accidental cessation of a critical medication that somehow became "de-listed" in the EMR and thus not administered. This resulted in severe complications, domino-style, including brain hemorrhage.

So into the hospital she went via ambulance again. The ambulance crew copied her meds off a list I keep on my relative's refrigerator onto a scrap of paper. In the hospital the ED nurse reviewed the meds with me from the scrap, but I informed the ED nurse that doing so was not necessary since I'd just carefully checked the ED EMR med list at triage less than 24 hours earlier at the triage station.

The ED nurse then replied - "we're not using the ED EMR med lists right now, the system's been 'glitchy' today."

Me - " 'Glitchy?' What does that mean?"

ED nurse - "Sometimes the EMR pulls up the patient's meds, sometimes it doesn't." (direct quote).

Needless to say, these were not exactly words I enjoyed hearing.

My relative was believed to be having a repeat of the ischemia to the brain or "TIA" (transient ischemic attack, i.e., threatening to have a stroke), only this time the ED EMR itself was also having a TIA.

[As it turned out, it later became apparent she was actually having low-grade seizures from the brain injury of May 2010, and was put on an anti-seizure medication - ed.]
In this progressive "paperless" setting, I was the sole conduit of accurate information about her meds. However, not every elderly patient has an advocate with my background...

My relative's TIA symptoms improved somewhat and she went to ICU, and was set up for a slew of tests to see what should be done, but these "every time I enter a hospital" EMR problems are getting a bit beyond what I consider as mere personal bad luck.

She was then transferred to a tertiary care hospital's critical care floor for neurological problems. Before transfer, I asked to see the results of her neck and brain scans.

A doctor brought them up on the computer screen, but rapidly scrolled down to the impression section. The doctor hoped I didn't see what was at the top of the radiological report. But I did. I saw a statement like this:

"A duplicate medical record number, previously unknown, was discovered for this patient."

Out of exasperation, I did not raise a commotion, but I can only wonder what data might have gone into that "previously unknown" silo.

After transfer to the tertiary hospital, the commercial EMR on a cart on wheels ("COW") outside my relative's room was displaying the EMR main screen, with a "patient worklist" window also open in the screen's center.

(The GUI appeared, by the way, to be that of obsolete Windows 2000 or NT 4.0, although possibly it could have been XP set to display the older GUI appearance, but the icon appearance suggested the former possibility).

Superimposed over the central patient worklist window, though, was a dreaded Microsoft crash window, exactly like this one from the Web:


An error window like this was superimposed on the EMR screens being used to manage my relative's care. Click to enlarge.

In asking the RN about this, I was told this window popped up a lot, and was simply dismissed by users with one of the two buttons. The IT dept. had told clinical staff the problem was due to users "loading illegal software on the hospital computers." (This COW, incidentally, lacked any portals for thumb drives, floppies, etc.) It sounded like IT would fix it when they managed to get around to it. The nurses went about their business, ignoring this screen when it popped up unpredictably but regularly.

Somehow, this did not inspire within me great confidence in the integrity of that EMR and its data, especially the admonition that:

"If you were in the middle of something, the information you were working on might be lost."

As an aside, I remember hearing a story like this over ten years ago in a past life as CMIO of a large hospital, in the Cath Lab as I detailed here:


... The informaticist [a.k.a. me - ed.] first asked to see what had been installed in the cath lab by MIS. The informaticist found workstations running the application under Windows 3.1, an unreliable platform especially unsuited for critical care environments, because "Windows NT and other OS's such as UNIX were not supported by MIS." When shown a short demo of data entry by a nurse after a cardiac cath case, the workstation crashed, displayed a "general protection fault" error and hexadecimal debugging data. It had to be rebooted, with resultant time and data loss.
The informaticist asked the nurse about the crash and was told it happened frequently, up to several times per day per workstation. When the informaticist asked if MIS had requested a detailed log be kept of the crashes and error messages to help resolve the problem, the answer was no. MIS felt diagnosis and repair was the vendor's responsibility. When the informaticist asked the nurse exactly what had been explained to clinicians about the crashes, the nurse replied that cath lab staff had been told by MIS "don't worry about it, you can't understand it, we'll make it better."
The informaticist remembered, from medical school and residency, being told never to say such a thing to patients as it was considered inappropriate and too paternalistic in the modern age of medicine, especially with the elderly. This was an ironic and somewhat perverse scenario for a critical care area, the informaticist thought.

I find the repeat of a story like this simply stunning.

As probably 2/3 of my healthcare-worker students have related stories of EMR-induced clinical problems in their organizations in the past several courses I've taught [typical
examples of student stories are at this link], and other mentees with worse tales in their CMIO roles, and now with my own experiences getting more and more theatre-of-the-absurdish, I offer this thought:

Perhaps my experiences are merely anecdotal, due to some bad karma that causes me to attract bad electrons and stale bits, disrupting EMR operations.

Yes, that must be it.

-- SS

Saving My Mother Yet Again. EHR Legible Gibberish - Another Example, the ED EHR Allergy List - And Legal Threats for Exposing Problems

My brain-injured mother was admitted to a suburban hospital (recently acquired by the "big hospital" where her EHR-related injuries of 2010 had occurred) Saturday morning.

She was again in a confusional state (delirium) of unknown cause, probably recurrent infection.




Of note, almost every time I see hospital EHRs, I note a problem.

In my Jan. 2011 post on this issue at the same organization, "EHR Problems? No, They're Merely Anecodotal; the Truth Must Be That I Attract Bad Electrons and Stale Bits" I observed a nurse-stated "glitchy-ness" that day that manifested as unreliability in pulling up the patients' current med lists. I had to be the conduit of my mother's meds, despite having gone through them in detail for computer entry in the exact same ED just 24 hours prior after a fall:


... My mother was having a repeat of the ischemia to the brain or "TIA" (transient ischemic attack, i.e., threatening to have a stroke), only this time the ED EHR itself was also having a TIA.

This was not the "FirstNet" ED EHR by Cerner forensically analyzed by Dr. Jon Patrick (as I wrote about here), but another ED EHR, by a company whose ICU physiological monitoring system I once as CMIO struggled with due to repeated, unexplained crashing.

On this most recent ED visit/admission to the satellite just days ago, I noted another problem with the ED EHR system (the same one that started my mother's travails at the main facility in May 2010, and now in use at the satellite).

When the ED nurse brought up my mother's allergies, they were repeated over and over and over on the ED screen, in a long recurrent list dozens of lines long, as if they'd been cut-and-pasted multiple times at each visit. She apologized to me. See images of a printout that was provided to me by an ED attendant upon my request as my mother's POA, below (names of hospital, patient, EHR, and EHR screen layout digitally redacted):



Allergy list, page 1 (excerpted from an on-screen continuous list). Click to enlarge.




Allergy list, page 2 (excerpted from an on-screen continuous list). Click to enlarge.



Allergy list, page 3 (excerpted from an on-screen continuous list). Click to enlarge.


Note that on-screen these appeared as a long, confusing list.

The repetition made the list near useless to the ED personnel (for example, they don't have time to look for the one crucial item that ISN'T a duplicate in the mess).


Legible gibberish indeed.

The ED RN just asked me about my mother's allergies, saying she could not make sense of the computer list and wanted to make sure no mistakes occurred. This is an appropriate attitude - the only appropriate attitude - for a clinician. Fortunately, I'm a doctor and know the allergies well.


The hospitalist then called me that night suggesting she would give my mother Levaquin, an antibiotic. For the umpteenth time I had to tell a doctor at these facilities my mother was allergic to Levaquin. This was in fact one of my complaints on my April 2010 warning letter to the hospital's CEO and CMO on EHR deficiencies I'd noted in my mother's care. This was just one month prior to her catastrophe, when a critical heart medication "disappeared" in the ED EHR, causing a cascade of medication continuity failure.


Yesterday I insisted the duplicate entries be removed (more precisely, "made inactive" - they still appear, but in a different color than "active" entries).


It is, on first principles, inherently harmful to the public to have critical patient data stored in disarray in an Emergency Room electronic health record.

See the above images, and ask if this is what you'd want busy ED doctors to have to wade through to figure out if a drug they're about to administer might injure or kill you.


-- SS

Post legal-threat addendum:

I'd originally posted actual screen shots (PHI and hospital name redacted) of the allergy lists provided to me by an ED attendant upon my request as my mother's POA.

On April 8, 2011, however, I received a threatening letter from the attorney representing the hospital claiming these screens were viewed by the client as "copyrighted and proprietary information" that I had "misappropriated" (stolen).


(This raises the question as to who, exactly, the "client" is - the hospital, or the EHR vendor?)

In any case, I was asked to "retract from the blog the copyrighted and proprietary information" under threat of the hospital "pursuing all remedies under the state's trade secret laws and Federal Law." Further, I was accused of "inappropriate behavior" in trying to protect my mother from further EHR-related accidents.

The allegations (actually, fabrications) of "medical records misappropriation" and "inappropriate behavior" were especially outrageous and unprofessional, considering the hospital had already altered my mother's medical record by adding the medication they missed to the ICU H&P as at this post, was caught at it, and had admitted it to me.

I have now done as asked, only posting the allergy information and dates without the background EHR tabs of the screen header, the only component that could even remotely be viewed as protected IP (i.e., of the EHR vendor).

I had a followup discussion with a senior nurse involved in the EMR project about those screens and the legal threats, which I viewed as potential retaliation aimed at discriminatorily denying my mother and I use of public accommodations, i.e., the hospital, through intimidation. (If my seeking records legitimately was "inappropriate behavior", who knew what else I might be falsely accused of to "discourage" my return?)

I was informed with a straight face that the allergy repetition was a "feature", not a bug.

The problem was "the nurse in the ED", who did not understand they needed to "look at the dates" to understand the allergy list. ["Blame the user" is typical in this domain - ed.] This senior nurse clearly had an amateur's understanding of HCI and clarity of presentation of information - or was simply talking down to me.

I provided a reminder that with 20 years of Ivy academic, big hospital (much larger than hers) and Big Pharma experience in this domain, I found her arguments specious.


Amateurism on presentation of information is a factor that promotes EHR-related error.
(It is my hope the original ED nurse is not punished for protecting patients instead of "protecting the computer" and its faults.)

-- SS

How One Hospital's EMRs and the "Experts" Who Designed, Acquired, Implemented And Used Them Ruined Mother's Day

This post is a personal account of a disastrous encounter with healthcare information technology (HIT) by my own mother. This "as it happened" account should put an end to doubts as to the toxic effects that poorly designed and implemented health IT can have on medical care, even on relatively basic issues such as tracking of a mere five common medications.

Today is Mother's Day.

I weep.

It's almost one year to the day when my mother suffered severe and now clearly irrecoverable cardiac and brain injuries due to an EMR-related catastrophic blunder in the ED of a large hospital.

She spent the entire night last night in an agitated delirium, which is occurring more often now, with me, her son, tending to her needs. Not even strong sedatives helped much. It is only now, this morning at 9:30 AM, that she has finally drifted off to sleep, giving me the time to write this.

To the (ir)responsible people at the hospital, I offer my sincerest ingratitude for what you did to my mother through stupidity. Ignoring my confidential April 2010 warning letter to the CEO and CMO about my observations of your organization's EHR deficiencies did not ingratiate me to your organizational culture, either.

Yet I hope your mothers are healthy and responsive to your gifts and appreciation on this day. I honestly do.

I would not wish what my mother went through (cerebellar hemorrhage) on anyone.

Here's a sampling of how such errors occur due to the toxicity of EHR's:

My mother was placed on a medication, Sotalol Hydrochloride, by this hospital's cardiologists in appx. 2001 to prevent atrial fibrillation.

An ED visit of April 2010 shows Sotalol as a "current medication" (as did multiple ED and inpatient charts dating back almost a decade):

From the ED EHR of April 15, 2010 in an admission for abdominal pain from rectal stricture, resulting in an anoplasty (widening) as an elective outpatient surgical procedure a few days later:

ED EHR of April 15, 2010

CURRENT MEDICATIONS

1) Cozaar: 25 milligram(s) PO Daily. [For high blood pressure - ed.]
2) Albuterol: unknown dose. [For bronchitis - ed.]
3) Restoril: 30 milligram(s) PO Daily. [Sleeping pill - ed.]
4) Humulin N: 10 units in am,8 units in pm. [Insulin - ed.]
5) Sotalol Hydrochloride: 120 milligram(s) PO Every 12 hours. [For heart rhythm, see here - ed.]

PAST MEDICAL HISTORY

MEDICAL HISTORY
: Hernia NOS , Atrial Fibrillation [a dangerous heart rhythm that Sotalol prevents - ed.], DMII Wo Cmp Nt ST Uncntr [diabetes - ed], Bronchitis, Urinary Tract Infection NOS, Hypertension.

This is not exactly a complex or taxing medications list or medical history.

Now, from the ED EHR of May 19, 2010, after a Transient Ischemic Attack with temporary slurred speech (aphasia) and narrowed left carotid artery identified as the culprit:

ED EHR of May 19, 2010

CURRENT MEDICATIONS

1) Albuterol: unknown dose.
2) Humulin N: 10 units in am,8 units in pm.
3) Cozaar: 25 milligram(s) PO Daily.
4) Restoril: 30 milligram(s) PO Daily.
5) Atrovent HFA

[Note that something important's missing - the critical heart rhythm maintaining medication, Sotalol. It's simply gone - de-listed - even though WE WERE ASKED on May 19 in the ED if she still took it based on the computer's current meds listing of April 2010, and replied "yes." It then somehow disappeared ... perhaps due to a
mission hostile user interface, or quality issues analogous to these ED EHR observations from Down Under? - ed.]

PAST MEDICAL HISTORY

MEDICAL HISTORY: Hernia NOS , Atrial Fibrillation, DMII Wo Cmp Nt ST Uncntr, Bronchitis, Urinary Tract Infection NOS, Hypertension.

SURGICAL HISTORY:
anaplasty [misspelling in the original; errors like this make record searching and data analyses a challenge. "Anaplasty" and "anoplasty" are quite different. But what's a little EHR error among friends? - ed.]

PSYCHIATRIC HISTORY:
No previous psychiatric history.

SOCIAL HISTORY:
Denies alcohol abuse, denies tobacco abuse.

MEDICAL HISTORY:
[Obviously repetitious of the above, but this is exactly how the record appears - ed.] Hernia NOS, Atrial Fibrillation, Dmii Wo Cmp Nt St Uncntr, Bronchitis NOS, Urin Tract Infection NOS, Hypertension, bronchiectasis, TGA in 88, post-herpetic neuralgia, possible WPW variant.

SOCIAL HISTORY:
Denies alcohol abuse, denies tobacco abuse, lives alone with son nearby. [Also duplicative; a little cut 'n paste action? - ed.]

------------------------

Note that the duplicate versions of MEDICAL HISTORY and SOCIAL HISTORY at the bottom contain critical information not in the versions at the top, such as "possible WPW variant" and "lives alone with son nearby."

WPW syndrome (Wolff-Parkinson-White) is a syndrome that predisposes to heart rhythm disturbances such as supraventricular tachycardia (SVT) and atrial fibrillation. I offered that history to ED staff as a reason my mother took Sotalol. I also offered that I once had the WPW syndrome myself, and had recurrent episodes of both SVT and atrial fibrillation, until intervention via the 'catheter ablation' technique in the mid 1990's. The "WPW variant" made it to her chart. The medication did not.

This ED EHR report is a major information presentation faux pas, showing sloppy report generation and poor presentation of information, since people in a hurry -- such as in an ED, or in an ICU where my mother was admitted -- may not scan the duplicate versions below for critical data not in the top version. The repetition with added items in the lower-down versions is inexcusable.

This is the type of IT work done by amateurs. In fact the shabby ED EHR output could be considered an accident of omission waiting to happen. I covered this type of flaw here: http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and.html .

------------------------

So what meds actually were ordered after she left the ED and entered the ICU?

These:


Click to enlarge. Note the remarkable resemblance - or should I say identicality - to the 5/19/10 ED EHR medication list above. These were then entered into the floor CPOE system.


No Sotalol.

Several days later, after my mother was transferred out of ICU to the neuro floor in prep for a carotid stenting, my mother went into uncontrolled atrial fibrillation. In front of my eyes at around dinnertime. Sotalol has a half life of just about 12 hours. After a few days of missing it, it's effectively gone, at a level so low in the blood as to be ineffective.

I immediately asked nursing to call the physician, and asked how this was even possible on Sotalol. All I got back was a puzzled look.

Sotalol had never been ordered.

Long story short, in correcting the iatrogenic atrial fibrillation (the arrhythmia itself a stroke risk), Sotalol was restarted and IV heparin and electrical cardioversion (shock to the chest) were employed.

While initially successful in restoring normal heart rhythm, the IV heparin then precipitated a massive cerebellar hemorrhage around 2 AM the next morning (in an area of the brain entirely different from the cerebral language center supplied by the carotid). IV heparin is a dangerous drug you especially want to avoid in the elderly.

In what I thought might be her last words to me, all my mother could say when I arrived as they were taking her for surgery was a very agitated and frightened-out-of-her-wits "Scot-headache-headache-headache-I'm sick-I'm sick-I'm sick." The headache pain from the bleed must have been absolutely excruciating and horrendous.

She had the pallor of death about her.

The sheer horror of that moment, seeing my mother like that, sticks with me even though I am a physician.

Her CT looked dreadful, much like the stock image below:


Click to enlarge. When I saw her CT scan, I prepared to say my goodbyes.


Emergency craniotomy (brain surgery) was then performed by a neurosurgeon to save her life, followed by months of medical complications and agitated delirium resistant to most medications.

The brainstem sits anterior to the cerebellum, and brainstem compression from the bleed caused paralysis of the muscles of swallowing. A surgically placed stomach feeding tube through the abdominal wall was thus required, which in her delirium she yanked out, thus forcing total parenteral nutrition (TPN) via a central (deep) IV line until the site healed. (She was lucky she did not do herself a major injury by pulling the through-the-abdomen gastric feeding tube, which should have been far better protected with a delirious patient.)

The first ingredient I noted in the initial TPN bag was a medication my mother was allergic to, famotidine, but another EMR defect I uncovered prevented the clinicians from realizing this. It was only my personal knowledge that prevented administration. I ended up filing my own FDA MAUDE report on this EHR defect...to my knowledge the hospital did not, and has not.

The complications of the bleed and craniotomy surgery also forced the re-started Sotalol to be discontinued, as bleeds in the head adversely affect the heart's electrical intervals, and a drug like Sotalol can kill under those conditions (e.g., see Torsade de Pointes).

The forced discontinuation of Sotalol resulted once again in sudden return of atrial fibrillation that is now permanent. Correction or even appropriate anti-stroke treatment would require anticoagulation such as heparin and coumadin, and these are contraindicated due to the bleed.

My mother has been painted into a very bad corner, with irreparable cardiac injury putting her at increased stroke risk, and a severely damaged brain that has resulted in her being an invalid who frequently is in an agitated delirium, and/or no longer recognizes her own son. While her swallowing returned after several months, her mind never recovered.

In effect, the EHR toxicity caused the following personnel (at the very least) to miss my mother's Sotalol de-listing, which apparently propagated from ED to ICU to floor due to lack of any discernible fail-safes or meaningful reconciliation:

  • ED triage nurse
  • ED physician [who stunningly notes in the record "She had a prior history of atrial fibrillation. However, per her report this has resolved and she is not currently taking any anticoagulation." A true statement - except he forgets to address the first-year medical student-level question: "atrial fibrillation resolved - how?" The answer that I'd related to him was "her atrial fibrillation resolved on Sotalol"; Sotalol is a take-for-life drug. On the NIH page about Sotalol: "Sotalol controls your condition but does not cure it. Continue to take Sotalol even if you feel well. Do not stop taking sotalol without talking to your doctor."]
  • ED staff nurse
  • Two neuro-interventionalist physicians
  • Multiple medical residents
  • ICU physicians
  • ICU nurses and staff
  • Floor nurses and physicians after transfer from ICU to neuro floor

I further observe: it is nearly unbelievable to me that not one person out of all the clinicians who saw my mother during this admission, even when transferring her from ED to ICU to floor, detected this fundamental, major medical error via ED and inpatient histories dating back almost a decade. Is interfacing between the floor and ED EHRs an issue? Are the EHR's too mission hostile for busy clinicians to use? What in hell was going on here?


You'd think that for the $25+ million dollars spent by this organization on HIT, the IT could have included failsafe features on meds and other life-critical data. Has the computer become deified in this culture; its outputs, a Testament that nobody challenges?
I tragically note that one Sotalol pill, worth perhaps a few cents, probably could have prevented the catastrophe if the error had been detected even as late as floor transfer from ICU.

To add insult to injury, the following was added to the ICU H&P sheet some time after the catastrophic brain bleed:

Click to enlarge. A very unwelcome discovery when I asked the neuro floor RN to see the chart a few weeks after the accident. Entry #8 was not present the day the Sotalol error was realized; I was shown the chart at that time.


Undated, untimed additions to medical charts with illegible signatures violate Joint Commission, Medicare and State Medical Professional standards of conduct, among others.

I leave it to the reader as to why this chart alteration might have been attempted.

When I saw this, needless to say, I was very upset. I demanded an immediate printout of the eMAR (electronic medication administration record), lest that be altered as well. The eMAR fortunately showed Sotalol had indeed not been ordered prior to the onset of the A. fib. I do not know what it might have showed a week ... or a month ... later, had I not been a nosy and medicine/medical informatics-educated patient advocate for my mother.

As I did not have my Power of Attorney documents for my mother with me, I demanded the eMAR printout and copy of the altered ICU H&P be sealed in an envelope whose glue flap I signed, to be held until I retrieved my POA documents from the nearby bank allowing me to take custody of copies of both these documents.

This is how toxic these wonderful non-FDA approved or vetted, Obama HITECH-pushed Cybernetic Revolutionizers of Medicine can be, when not "done well."

It should be noted that further errors of this type at this hospital system would very likely amount to criminal negligence.

Happy Mother's Day.

-- SS