Showing posts with label UPMC. Show all posts
Showing posts with label UPMC. Show all posts

Tuesday, March 26, 2013

The Push Back Continues: the Mayor of Pittsburgh Sues UPMC Claiming it is No "Public Charity"

There is another indication that push back against the power of large health care organizations is getting more significant.

In February, 2013, we noted that the Governor of the state of Connecticut publicly criticized lavish executive compensation at a small regional hospital system, compensation partially fueled by government funded health insurance payments, and in contrast to hospitals' claims that insufficient reimbursement was driving them to poverty.   

The Suit Challenging the Charitable Status of UPMC

Now the outgoing Mayor of Pittsburgh has launched a lawsuit challenging the status of huge, nominally non-profit health system UPMC as a public charity.  A summary of the arguments comes from an article in the Pittsburgh Post-Gazette.  First, in the state of Pennsylvania, a Supreme Court description set out a test to determine if a particular organization is a public charity, the status the UPMC currently claims:

The Supreme Court's 1985 ruling involving the Hospital Utilization Project (or HUP) set out a test that requires that a purely public charity must fulfill all five of the test's points that it: advances a charitable purpose; donates or renders gratuitously a substantial portion of its services; benefits a substantial and indefinite class of persons who are legitimate subjects of charity; relieves the government of some of its burden; and operates entirely free from private profit motive.

That ruling was reaffirmed by the Supreme Court in April in a case involving an Orthodox Jewish summer camp in Pike County that was found to not deserve its property tax exemption.

The city's lawyer, E.J. Strassburger of Strassburge Mckenna Gutnick & Gefsky, argued that UPMC does not pass that test:


Mr. Strassburger wrote, first and most strongly, that 'it seems virtually certain that UPMC would fail to carry its burden of proving that it satisfies the fifth prong of the HUP test by 'operating entirely free from profit motive.''

He cited UPMC's nearly $1 billion surplus over the last two years and $3 billion in reserves as evidence of this, and that UPMC 'is carefully structuring its operations to prioritize profits-generation over charity.'

Also, 

In addition, Mr. Strassburger wrote that UPMC does not 'advance a charitable purpose' in part because UPMC 'maintains an 'open admissions policy' in name only' and it does not make all of its health care available to everyone, regardless of ability to pay.

Furthermore,

the review says UPMC fails to provide sufficient charity care, operates far-flung international operations that are losing money, and has closed operations in poor communities only to open or expand into richer ones.

But it also cites what it terms 'excessive' benefits of UPMC executives, including CEO Jeffrey Romoff's $5.9 million salary; the fact that more than 20 employees are paid more than $1 million; UPMC's corporate jet; Mr. Romoff's 'lavish'  Downtown headquarters (which it claims includes a private chef, chauffeur and private dining room).


The Post-Gazette also sought the advice of experts,


Nicholas Cafardi, dean emeritus and professor at Duquesne University's Law School, said he believes the argument that UPMC is not free from a private profit motive is the strongest one in Mr. Strassburger's review, in part because of how far-flung UPMC has become.

'The more they do that gets them away from their core purpose, the more they open themselves up to the argument that they aren't doing charity,' he said.

In addition, Mr. Cafardi said, UPMC's extensive advertising campaign --sometimes directly against rival Highmark -- makes it look like the organization is operating for profit.

'A lot of things like that make them look like they're operating for a private profit,' he said. 'You advertise because you're in competition. That's the private profit motive.'

Gary M. Grobman, former head of the nonprofit Pennsylvania Jewish Coalition and author of 'The Pennsylvania Nonprofit Handbook,' said UPMC would have a fight on its hands.

'Based on what [Mr. Strassburger] has written, which may or may not be true, it seems some staff at the hospital are paid quite well and some decisions are made based on achieving as much revenue as possible instead of providing as much charity as possible,' he said. 'And if all of that is true, they don't deserve their not-for-profit status.'


So the main issues brought up by the city are similar to issues we have raised about numerous nominally non-profit health care organizations.  We have shown that many particular organizations appear not to act like charities when they appear to put short-term revenue ahead of the organization's mission, a process sometimes called financialization, and put lavish compensation of top hired managers ahead of the organization's general financial well-being; and when their leadership appears to subvert the organization's mission.

The UPMC Response versus Anger in the Community

Of course, UPMC public relations disagreed with the premises of the lawsuit:

'We think the 13-page memo that a local law firm wrote for the City is very weak and reaches its conclusions entirely based on opinion, not fact,' UPMC spokesman Paul Wood wrote. 'Rather than responding to partisan politics and blatant union pandering by the Mayor, UPMC looks forward to demonstrating in a court of law that we meet all five prongs of the HUP test and that our hospitals easily qualify for the tax-exempt status they unquestionably deserve. Interestingly, by hiring an outside law firm the City is prepared to waste millions of dollars of taxpayer funds on an unsuccessful attempt to pursue this case.'

Note that the unsubstantiated allusions to "partisan politics" and "pandering" appear to be an appeal to ridicule, "a fallacy in which ridicule or mockery is substituted for evidence in an 'argument.'"  We have noted before how public relations flacks working for top executives of health care organizations seem to be very good at using such logical fallacies.

Mr Wood also scoffed at the naive notion that having a $1 billion surplus and $3 billion in reserves means the organization operates like a business:
 
Mr. Wood wrote that 'numerous people have tried to distort the meaning of that component to attain a political result.'

'It does not mean a nonprofit shouldn't strive to have a positive operating margin -- organizations that don't do that go out of business,' he added.

Note that Mr Wood seems to be arguing that the only alternative to a very large surplus and a very large reserve is a deficit.  By ignoring another obvious alternative, having a small surplus and a small reserve, his argument thus is derived from the logical fallacy known as the false dilemma.  He also seemed to be arguing that a deficit inevitably leads to bankruptcy.  Of course prolonged deficits might lead to bankruptcy, but a single deficit would not necessarily do so.  Thus he also employed the logical fallacy known as the slippery slope

On the other hand, a Post-Gazette columnist showed the depth of community concern over the role of UPMC:

Someone in power is taking official action against the biggest corporate bully in town. Can I get an Amen?

In fact, I can get many Amens, and that says a lot about the behavior of the region's dominant hospital system.

Has there ever been a 'charity' so disliked and mistrusted by the people it's supposed to serve and the people it employs? You rarely hear anyone say 'I cannot stand CARE,' or 'I despise Doctors Without Borders.' But you hear it all the time about UPMC, notwithstanding the jobs it creates, the medical innovations it advances, the life-saving care its doctors deliver and its commitment of $100 million for the Pittsburgh Promise scholarship fund. With all that to its credit it should be beloved, but the opposite is true.

Not helping matters is its corporate public relations, which is increasingly tone deaf. In an emailed response to the mayor's announcement, UPMC spokesman Paul Wood said the lawsuit 'appears to be based on the mistaken impression that a non-profit organization must conduct its affairs in a way that pleases certain labor unions, certain favored businesses, or particular political constituencies.'

No, Mr. Wood. It's based on the correct impression that a nonprofit hospital's top priority should be the patients, not building a monopoly. And that a $10 billion system with a billion-dollar surplus and $2 billion to $3 billion in reserves should be taking care of many more indigent sick people than UPMC has been treating -- especially when it owns land that a Post-Gazette investigation valued at $1.6 billion, even as it enjoys a $20-million tax break every year, underwritten by the good citizens of Pittsburgh and Allegheny County. You can try blaming the SEIU organizing campaign or your arch-enemy, Highmark the insurer, or politics, but this is so much bigger than any of those things. And the public knows it.


Keep in mind that the current discussion of UPMC in the media focuses on very recent events.  On Health Care Renewal, we have posted frequently over the last eight years about problems with the leadership of UPMC.  We started in 2005 with their inability to prevent a fraud  perpetrated by some UPMC middle managers. In 2008, we discussed the apparent mismanagement of the highly touted UPMC liver transplant program.    Starting in 2009, and continuing through 2013, InformaticsMD chronicled how the leadership has presided over health care information technology so problematic that it has been blamed for patient deaths.  In 2009, we noted sanctions against UPMC's public relations.   In 2010, we noted conflicts of interest and apparent self-dealing and nepotism affecting the UPMC board of trustees and UPMC executives. 

Summary

For at least a generation, health care leaders and health policy makers have been pushing for consolidation of health care organizations in the name of efficiency.  We now have a health care system dominated by fewer, larger organizations, and whatever efficiencies have been produced mainly seem to have benefited organizational insiders.  Maybe now, though, some are beginning to remember that monopolists - starting at least with John D Rockefeller, I believe - have historically touted their ability to improve efficiency and rationality.  The results, however, have been higher prices and poorer results for everyone else. 

Hospitals and hospital systems have been particularly good at getting away with the efficiency argument despite the fact that health care prices in the US have been soaring ever since the "vertical integration" craze in the early 1990s.  I believe such organizations have been getting away with this nonsense because of their revered status within their communities.  Now, however, as huge hospital systems drive up prices and make their top executives rich, maybe we will remember Theodore Roosevelt's warnings about trusts and malefactors of great wealth.

There is no good evidence that large hospitals and even larger hospital systems take better care of patients, or provide better teaching and research.  Not only should we question whether huge hospital systems like UPMC are public charities, we should wonder how we ever let them get so big, and proceed to break up these new sorts of "trusts."


Sunday, April 8, 2012

The Pittsburgh Experiment - II - Another Echo of the Fall of AHERF

We recently started a series of posts about the battle for domination of health care in western Pennsylvania.  The contenders are the UPMC hospital system, the dominant hospital system in the region, and Highmark, the dominant health insurer in the region.  While these two health care behemoths fight, patients, health care professionals, and the public seem to be caught in the crossfire.

There is something of history repeating itself in this battle.

The biggest bone of contention in it is Highmark's attempt to purchase the struggling West Penn Allegheny hospital system.  UPMC leadership seemed to feel that this would put the insurer in direct competition with it, even though UPMC already provides a health insurance product, the UPMC Health Plan.

West Penn Allegheny, in turn, is struggling because it is a remnant of a previous attempt by a single organization to dominate the health care system in this area.  As we wrote in 2011,  West Penn Allegheny was formed from some components of what used to the be the Allegheny Health Education and Research Foundation, AHERF.   AHERF was a large integrated health care system formed out of multiple mergers.  AHERF went bankrupt in 1998, leading to massive layoffs, hospital closures, and the near dissolution of a medical school (which ended up taken over by Drexel University).

As we noted in 2008, although the AHERF bankruptcy appears to be the largest failure of a not-for-profit health care corporation in US history, its story has produced remarkably few echoes for doctors, other health care professionals, health care researchers, and health policy makers. I often use the fall of AHERF as major example in talks, at least the few talks I am allowed to give on such unpleasant subjects. Rarely have more than a few people in the audience heard of AHERF prior to my discussion of it. I only could locate one article in a medical or health care journal that discussed the case in detail, albeit incompletely since it was written before Abdelhak's guilty plea [Burns LR, Cacciamani J, Clement J, Aquino W. The fall of the house of AHERF: the Allegheny bankruptcy. Health Aff (Millwood) 2000; 19: 7-41.] I doubt the case is used for teaching in most medical or public health schools. (There is a new book out about the case, Merger Games, by Judith Swazey, available here as  a set of PDF files from Project Muse for those with the proper password, but it has not yet had much of an impact, and I confess I have not yet read it.)  The lack of discussion of such a significant case is a prime example of the anechoic effect.

Therefore, let me summarize some of important points about AHERF not found above (see also this narrative, starting on page 5):


  • AHERF, one of the largest health care systems of its day, was built by the poster-boy for health care imperial CEOs, Sherif Abdelhak.
  • Abdelhak, who started as food services purchasing manager at Allegeheny General Hospital, was repeatedly hailed as a "visionary" (in the March, 1997, ACP Observer) a "genius," and the like. His plans to create a huge integrated health care system were part of the wave of the future. Abdelhak was even invited to give the prestigious John D Cooper lecture at the annual meeting of the American Association of Medical Colleges (AAMC), which was published in Academic Medicine [Abdelhak SS. How one academic health center is successfully facing the future. Acad Med 1996; 71: 329-336.] He proclaimed that "we will need to create new forms of organization that are more flexible, more adaptive, and more agile than ever before." And he announced that "my aim as chief executive has been to unleash the creativity and productive potential of every individual and to provide an environment that encourages teamwork"
  • While Abdelhak was making these grandiose promises, he paid himself and his associates very well. For example, he received $1.2 million in the mid-1990s, more than three times the average then for a hospital system CEO. He lived in a hospital supplied mansion worth almost $900,000 in 1989. Five of AHERF's top executives were in the top 10 best paid hospital executives in Philadelphia.
  • Although Abdelhak talked of teamwork, he warned the combined faculty of the new Allegheny University of the Health Sciences (AUHS): "Don’t cross me or you will live to regret it."
  • As AHERF was hemorrhaging money, Abdelhak continued to pay himself and his cronies lavishly.
  • After the AHERF bankruptcy, which was at the time the second largest bankruptcy recorded in the US, Abdelhak was charged with numerous felonies involving receiving charitable assets. In a plea bargain, he pleaded no contest to misusing charitable funds, a misdemeanor, and was sentenced to more than 11 months in county prison.
The story of AHERF is not merely that of an unlucky bankruptcy. It shows what can go wrong when health care adopts business practices such as jumping the latest management band-wagons and genuflecting before imperial CEOs.  It also shows what happens when a single health care organization, and the person who leads it, becomes too powerful.

If either UPMC or Highmark definitively wins their current battle, the winner will become at least as locally dominant as AHERF.  As we shall see in the posts to come in this series, the leadership of both organizations has already demonstrated a certain arrogance.  Yet since 2008 we have not progressed to the point of controlling the tendency of a laissez faire health care system to approach monopoly, nor the monopolist's tendency to put his self-interest ahead of all else. 

If nothing else, maybe the messiness of the fight between UPMC and Highmark will remind more people of AHERF, hence the need not to let our health care leadership and governance problems remain anechoic, hence the need for true health care reform that would constrain health care leaders to put patients' and the public's health before their narrow self-interest. 

Thursday, April 5, 2012

The Pittsburgh Experiment - I - Caught in the Crossfire

In our increasingly dysfunctional health care system, patients, health care professionals and the public are often caught in the crossfire between big health care organizations.  Such organizations are often led by people who do not seem to put the interests of patients and the public, and the values of professionals first.  (Note that we have been writing about this since at least 2003, when the concept appeared in my article: Poses RM. A cautionary tale: the dysfunction of the American health care system. Eur J Int Med 2003; 14: 123-130. Link here.)

Last week, Anna Wilde Matthews and John W Miller wrote in the Wall Street Journal about an amazing example of such a crossfire that pitted the two dominant health care organizations in Western Pennsylvania against each other.  The case turns out to touch on many of the most dysfunctional aspects of US health care.  So rather than try to cram it into an overly long blog post, I plan to periodically discuss it over the next few weeks, starting now with an overview of the grappling titans.

The Basic Conflict

Per the Wall Street Journal article,
In Pittsburgh, the acrimonious battle between Highmark, the region's most powerful health insurer, and UPMC, the dominant health-care provider, is drawing national attention as a test case on the impact of consolidation in the health-care industry.

At the heart of the dispute is Highmark's effort to acquire a financially troubled local hospital group, West Penn Allegheny Health System, as the centerpiece of what it says will be a lower-cost and more efficient health-care operation. UPMC, which has its own insurance arm as well as 19 area hospitals and 3,240 doctors, says it doesn't want to bolster a company it now considers a direct rival. It has vowed not to sign a new contract to treat patients covered by Highmark, which would mean those patients generally would pay high out-of-network rates to use UPMC hospitals and doctors.

As we will see, the dispute is between a dominant hospital system that is trying to muscle into the insurance business, and a dominant insurer that is trying to muscle into the hospital business. If either were to succeed, it would become the dominant health care organization in the Pittsburgh area.

A Personal Fight Amongst Two CEOs

However, the fight soon seemed to be more among the CEOs of the two organizations. Per the WSJ,
In Pittsburgh, the battle has become unusually bitter, spearheaded by the two companies' chief executives, UPMC's Jeffrey A. Romoff, 66, and Highmark's Kenneth Melani, 58. Mr. Romoff, who has built UPMC into a $9 billion juggernaut and put its initials on the tallest skyscraper in the city, calls Highmark a 'monopoly.' Dr. Melani uses the same term in warnings about UPMC's power and referred to Mr. Romoff in a local newspaper as 'trying to rape the commercial marketplace to build his empire.'  (A spokesman for Mr. Romoff said the comment 'lacked both substance and dignity.')

An article from December, 2011 in the Pittsburgh Tribune-Review had illustrated other aspects of the bitterness about and between the CEOs.
UPMC CEO Jeffrey Romoff's satiric, fake Twitter profile lists his favorite games as Monopoly and Risk.

In recent tweets, the anonymous author wrote under his name, 'New York State, here we come!' and said he wants to take Highmark CEO Dr. Kenneth Melani 'outside to settle things -- but it would be unfair competition if (we) could BOTH use our fists.'

The month-old Fake Jeffrey Romoff persona, whose author declined to be interviewed but said it's 'no laughing matter,' depicts the head of Western Pennsylvania's dominant health care system as a greedy tyrant with an angry avatar. It counts fewer than 40 followers, but its existence points to a public relations failure for UPMC in its fight with Highmark Inc., media experts say.

'Nobody feels sorry for Romoff,' said Andrea Fitting, president of Downtown marketing firm Fitting Group. 'If you ask anyone on the street, they'll say Romoff is a monster. There's no person who's trustworthy and sympathetic who they've enlisted as a spokesman.'

Romoff could not be reached for comment.

UPMC spokesman Paul Wood said he is not concerned about the profile's effect on the hospital network's image.

'Not something that has virtually no followers,' he said.

There's no fake Twitter handle lampooning Melani, but experts say the state's largest insurer is not doing a great job of managing its public image either.

As found in the WSJ article,
'There's no white hat here,' says Don White, a Republican who chairs the state Senate committee overseeing insurance. 'They're both concerned about their self-preservation and domination.'

Neither CEO seems satisfied that his organization has become dominant in its field, and both seem to resent the success of the other organization in another field. Let us briefly review the backgrounds of both systems.

UPMC as Dominant Hospital System

The WSJ article started to probe the complexity of the situation:
The struggle in Pittsburgh has roots that go back decades. UPMC, led since 1992 by Bronx native Mr. Romoff, has grown on his watch to $9 billion in annual revenue from $797 million when he took over. Today, UPMC has around 58% inpatient market share in Allegheny County and a brand buoyed by its identification with nationally known research and treatment centers like Hillman Cancer Center, where Ms. Wyckoff is being treated. The nonprofit system, with around $406 million in operating income in its most recent fiscal year ended June 30, is also Pennsylvania's biggest private employer.

UPMC's initials dominate the Pittsburgh skyline from the top of the U.S. Steel Tower, the city's tallest building. The nonprofit leases a private jet that is used to fly executives and doctors to its facilities in Ireland and Italy. Mr. Romoff has become one of the city's most prominent business leaders. Poking fun at a local nickname for his boss, a staffer once presented Mr. Romoff with a Darth Vader action figure. In 2009, UPMC published a glossy history of its own expansion titled 'Beyond the Bounds.'

Highmark as Dominant Insurer

On the other hand,
As UPMC grew, its main hospital rival, West Penn Allegheny, withered. The five-hospital group emerged from the ashes of a Pennsylvania hospital system that filed for bankruptcy in 1998 after piling on too much debt and acquiring money-losing assets. It struggled for years.

By 2011, West Penn Allegheny was in the red, with heavy debt and pension obligations. To cut costs, it shut down much of its Western Pennsylvania Hospital. At one point, filmmakers took over its empty intensive-care unit to film a scene for a coming Tom Cruise movie.

In June, Highmark's Dr. Melani unveiled his plan to acquire West Penn Allegheny for a combination of loans and grants valued at as much as $475 million. Like UPMC, nonprofit Highmark was a dominant presence in its market, formed from the merger of a Blue Cross and a Blue Shield plan in 1996. By 2011, it had market share of around 60% in Allegheny County, with annual revenue of $14.8 billion, and it was sitting on reserves of about $4.1 billion.

Still, it was a bold and risky stroke for Dr. Melani, a blunt-spoken internal-medicine physician who himself trained at West Penn.

Marketing Rather than Substance

The two sides launched a marketing and public relations battle which did not seem to have much to do with quality of, access to, and cost of health care. As the WSJ article noted,
The spat quickly got nasty. Highmark highlighted UPMC's rate request in ads, and hired a Washington lobbying firm to pull together a coalition of churches, patient groups and others that would press for a deal. UPMC's own ad campaign urged patients to 'Keep your doctor. Check your plan.' Highmark sued, arguing the ads were misleading. UPMC bought Google ads that called up its site when a user searched for 'Highmark.'

The Pittsburgh Tribune-Review article included,
Public relations experts agree that Highmark faces a daunting challenge: People might see UPMC -- and by extension, Romoff -- as a bully, but they don't want to lose access to the system's 19 hospitals and 3,000 doctors in Western Pennsylvania.

UPMC's 'Keep Your Doc' ad campaign, produced by South Side agency GatesmanMarmion+Dave, is successful because it furthers the organization's business objectives, said Dale Leibach, an associate with Prism Public Affairs in Washington. This year, for the first time, UPMC gave four national insurers full access to its facilities and doctors, an arrangement previously granted only to Highmark.

'I would give points to UPMC for consistency and transparency, in promising more competition and then delivering on that promise by giving people in Pittsburgh and in the region many more options in terms of insurance providers,' said Leibach, who reviewed news accounts about the dispute.

David Kosick Sr., senior associate at KMA Public Relations in Canonsburg, takes the opposite stance, saying Highmark receives greater sympathy from a public that views UPMC as an insensitive corporate titan. Mullen Advertising in the Strip District produces Highmark's 'Accepted. Everywhere' ad campaign for TV, radio, publications, billboards and the Internet.

'Highmark's winning the PR battle,' Kosick said, citing threats by state lawmakers to intervene and public criticism directed at UPMC, including Allegheny County Council's refusal last month to issue $335 million in bonds for UPMC because of public opposition.

Wood said the health system recognizes its reputation 'may have taken a bit of a short-term hit locally,' but 'UPMC is focused on the longer term.'

'We've used our PR and marketing to fundamentally change the health care market in Western Pennsylvania,' Wood said.

Gene Grabowski, senior vice president of Washington-based public relations firm Levick Strategic Communications, said that strategy could backfire.

Also,
In addition to online social media, the public relations campaigns have ramped up on television and in other advertising.

UPMC placed its TV ads on major networks and cable and estimates they will reach the average Pittsburgh viewer four times a week, Wood said. He declined to say how much UPMC is spending on the ad campaign or what it budgets for advertising, but he said the budget has not changed since last year.

The ads, Fitting said, target 'what people are really worried about.'

Highmark stepped up its campaign in response to UPMC's, Weinstein said. He would not say how much Highmark pays Mullen Advertising or what it budgets for advertising.

'UPMC launched an aggressive, multifaceted misinformation campaign targeted at employers and consumers who subscribe to Highmark's health plans,' Weinstein said.

Caught in the Crossfire

Meanwhile, of course, patients and doctors are trying to avoid being stomped by the wrestling titans. The Wall Street Journal article opened with this theme,
Trish Wyckoff is struggling with stage-four breast cancer, but now the 53-year-old Pittsburgh resident has another worry: a possible divorce between the hospital system that is treating her, the University of Pittsburgh Medical Center, and Highmark Inc., the health insurer that pays for her care. If the two companies can't agree, she fears she won't be able to keep seeing the doctors who she believes are keeping her alive.


'We are absolutely stuck in the middle,' she says. This is a really scary time.'

Here is another anecdote,
With local newspapers chronicling each tit-for-tat, Pittsburgh residents like Dan Glasser say they have been acutely aware of the battle. Mr. Glasser, a 46-year-old lawyer, says he is alarmed and annoyed at the potential split between his insurer and UPMC. If forced to choose a side, he says, he would switch health plans to ensure access to UPMC. He has been seeing the same doctor there since he graduated from law school. 'That's almost my whole adult life,' he says.

Doctors are equally unhappy.
For his part, Kenneth Gold, Mr. Glasser's primary care physician, says he has been telling worried patients that 'all of us are pawns in this fight,' which he hopes gets resolved. If Highmark and UPMC do break up, 'it is going to be mass chaos,' he says.

Even employers are unhappy,
Employers, for their part, say they feel trapped in the middle, worried about health-care costs and also under pressure from employees to lock in access to UPMC. Cheryl Melinchak, director of benefits at Pittsburgh-based Westinghouse Electric Co., says the firm is likely to offer a new health plan this fall, in addition to Highmark and a high-deductible Aetna version, to ensure workers can use UPMC.

The standoff is 'frustrating,' she says. 'We need competition on both sides,' insurers and health providers.

Summary

So here we have the brave new world of the US health care system, a system that some people in other countries seem to think is worthy of emulation. Increasing concentration of power has lead to health care dominated by ever larger organizations lead by ever more egocentric executives. Organizations that are dominant in one area seek to dominate other areas. Caught in the crossfire are patients, doctors, employers, and the public. While more money goes to advertising, public relations, and lawyers, nothing about the fight seems to be about improving care or making it more accessible.

Further considering how this particular fight came to be will reveal various interlocking facets of health care dysfunction. If we can start to address them, we may be able to accomplish real health care reform.  Clearly we need health care organizations to concentrate on health care, not on increasing their power and domination.  We need them using most of their resources for health care, not on marketing, public relations, legal services, administrative support, and executive compensation. 

Stay tuned to Health Care Renewal as we continue this series.

Wednesday, December 28, 2011

IT Malpractice? Yet Another "Glitch" Affecting Thousands of Patients. Of Course, As Always, Patient Care Was "Not Compromised."

At my Nov. 2011 post "Lifespan (Rhode Island): Yet another health IT glitch affecting thousands - that, of course, caused no patient harm that they know of - yet" I wrote:

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches" here, here, here and at other posts which can be found by searching this blog on the banal term 'glitch'.

Add another case to the health IT glitch file, under the "do we feel lucky today?" patient risk category.

From the Pittsburgh Post-Gazette (I am quoted):


Computer outage at UPMC called 'rare' Systemwide disruption potentially dangerous, expert warns Saturday, December 24, 2011 By Jonathan D. Silver, Pittsburgh Post-Gazette

UPMC's electronic medical records system for inpatients went offline for more than 14 hours at nearly all its hospitals in the region, marking what the health system called a "rare" outage, but one that it claims did not harm patients.

First, as my aforementioned Nov. 2011 post and its contained links point out, these events are not as "rare" as they should be. (The asteroid colliding with Earth that caused the extinction of the dinosaurs - now that's a "rare" event.)

Second, as multiple posts on this blog have pointed out, the claims that "no patients were harmed" is both misleading and irrelevant:

Such claims of 'massive EHR outage benevolence' are misleading, in that medical errors due to electronic outages might not appear for days or weeks after the outage, depending on what information was corrupted/lost/misindentified/or otherwise mishandled after it is 'backloaded' once the system is up. All it takes is one med lost to cause misery and death. (I can speak about that from unfortunate personal experience.

Claims of 'massive EHR outage benevolence' are also irrelevant in that, even if there was no catastrophe directly coincident with the outage, their was greatly elevated risk. Sooner or later, such outages will maim and kill.

The outage affected a system designed by Cerner Corp., a global electronic records company, and customized by UPMC that doctors and nurses rely on for communication about patient records, medical orders and prescriptions.

It was unavailable from about 8:45 p.m. Thursday to 11 a.m. Friday at almost all of UPMC's hospitals except for Children's and UPMC Hamot in Erie, spokeswoman Wendy Zellner said.

"This is rare. This kind of widespread, extensive downtime would be rare," Ms. Zellner said.

Doctors and nurses continued to have access to patients' electronic records through backup systems, she said. They also had to resort to using old-fashioned paper records for documentation and orders.

"These things happen. They have really well spelled-out procedures for what to do when something goes down," Ms. Zellner said.

She acknowledged that doctors and nurses faced some challenges.

Faced 'some challenges?' In other words, care was compromised by the outage and the 'challenges' were to avoid medical error (and, of course, to make sure billing was unaffected):

Compromised -
a. To expose or make liable to danger, suspicion, or disrepute
b. To reduce in quality, value, or degree; weaken or lower.


Thousands of patients were affected, again reinforcing my point about how IT can and does greatly amplify the risks of paper -- as in my Rhode Island post -- such as errors and confidentiality breaches.

I cannot, for example, think of a single instance where thousands of paper records went unavailable simultaneously (unless, that is, someone lost the key to the Medical Records department), were made available to identity thieves en masse, or where thousands of medical orders were scrambled or truncated in a relatively short period of time as in Rhode Island.

These amplified risks could wipe out any advantages of EHR's over paper in a microsecond.


A partial list of facilities apparently affected in this latest episode of EHR mayhem, from this list:

That accounts for several thousand active patients, I am sure.

(12/28 Addendum: Bed counts of PA hospitals are here. Searching on "University of Pittsburgh Medical Center", it can be seen that thousands of beds were indeed involved.)

"Whenever people aren't working in their native system and workflow I have to believe that is more cumbersome for the clinicians, but these folks are well-trained in what to do when these things happen."

This seems at best an insensitive and perhaps even inhumane bit of P.R. More "cumbersome" for the clinicians? What about the poor patients? How would Ms. Zellner feel, I wonder, if it were her mother, child or significant other on the Operating Room table or having an acute MI when the EHR/CPOE systems went down?

Ms. Zellner said UPMC's public relations staff was unaware of the outage until contacted by a reporter.

It appears P.R. is not very high on the list for receiving information when a crisis arises. I may have known of the outage before they did.

The outage was caused by a "bug" or glitch in software designed by a vendor affiliated with Cerner, Ms. Zellner said. She refused to identify the company.

"We're not trying to point fingers at different vendors. It's a database bug, that's all I can tell you."

(That is, it's not our fault, it's the fault of the database vendor. Hospitals, I regret to inform you - you are responsible for unapproved medical devices used in your facilities, no matter what the source.)

And there's that word "glitch" again, accompanied by the equally banal "bug."

It's just a "bug." Cute little critter!

Me again in the Post-Gazette:

Scot M. Silverstein, a doctor and assistant professor Healthcare Informatics at Drexel University in Philadelphia, disagreed with the use of the terms "bug" and "glitch."

"What occurred here was a disruptive, potentially dangerous major malfunction of a life-critical enterprise medical device," he said.

Somehow, when a clinician makes a mistake, the terms "bug" and "glitch" are never used. In fact, when clinicians fail to meet accepted professional standards of healthcare practice, it is called "malpractice."

I think we can all agree that a major near-full-day outage of an enterprise EHR affecting multiple hospitals and thousands of patients does not meet accepted professionals standard of life-critical computing practice. Yet, all this merits is the word "glitch." It seems to me that if patients are harmed by, in reality, what is (on its face) IT malpractice during such events, not only the clinicians affected should be held liable.

Ms. Zellner said the problem was not a "crash" of the system because there were alternate methods used to cope that prevented patient care from being compromised.

The usual refrain. Let me repeat my definition of "compromised:"

Compromised -
a. To expose or make liable to danger, suspicion, or disrepute
b. To reduce in quality, value, or degree; weaken or lower.

A simple question - if extended EHR outages like this never seem to "compromise" care, then why not eliminate health IT entirely and spend the hundreds of millions saved on patient care?

"This is not a crash of Cerner either," Ms. Zellner said. "I think a crash is, 'Oh my God, the sky is falling,' nobody can get anything."

I leave it to the readers to ascertain the computer expertise levels and reasonableness of what Ms. Zellner thinks a "crash" is.

Technicians from UPMC, Cerner and the third company [the 'mystery' database company? - ed.] worked together on-site to identify and fix the problem. Ms. Zellner said she did not know why it took 14 hours to fix and the underlying cause was still unclear.

"They know what the problem is and I believe it's been fixed, but we really don't know what triggered it," Ms. Zellner said. "I think the next step would be some actual software upgrades."

They "don't know what triggered the 'problem'" - is a proper translation that they have no idea what went wrong?

In fact, regarding another Cerner EHR system which was extensively studied (see "A Study of an Enterprise Information System" at this link), Dr. Jon Patrick came to the conclusion that one of the sources of catastrophic failures is poor software engineering that has made the behavior of the studied system "non-deterministic." Further, software upgrades are not protected from incremental changes made by maintenance and customization staff, and may introduce even more instability.

A software upgrade without clearly understanding "what triggered the problem" is simply asking for more trouble. (My bet, however, is that they attempt it anyway.)

A Cerner representative could not be reached for comment.

What's to say?

How about this:

Dr. Silverstein said based on what he was told about the computer outage, it means that hospital medical staff would have been unable to update patient charts and probably would not have been able to issue any orders through the system during the time it was off line.

He also questioned how up-to-date the hospital's redundant records were.

Repeating UMPC's statement from the article that appeared after I gave my quotes to the reporters: "Doctors and nurses continued to have access to patients' electronic records through backup systems, [the UPMC spokesperson] said. They also had to resort to using old-fashioned paper records for documentation and orders."

My stated fears of disruption and increased risk due to compromised care seem well-grounded.

In May, Allegheny General Hospital had to shut its electronic medical records computer system down because of problems with the vendor's hardware.

The hospital used backup procedures to continue care for patients, including using paper orders and record-keeping.

Wait ... I thought I'd heard these events were "rare." Two in the same city within six months?

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

Truth be told:

The primary rule in computing is:


Either you are in control of your information systems, or they are in control of you.

Clearly the latter was the case here.

The following questions arise:

  • Was the software containing the "bug" properly vetted before being used on live patients? This is not just the vendor's obligation.
  • If it was not vetted properly, why not?
  • Was it an "upgrade" or patch? (If so, the same vetting rules apply.)

Further, the soft-selling of these incidents must end. The use of terms such as "bug" and "glitch" must also end. What occurred here, echoing my newspaper quote, was a disruptive, potentially catastrophic major malfunction of a life-critical enterprise medical device.

System-wide EHR crashes are not merely ‘glitches’ or ‘bugs.’ They need to be considered, as in medicine itself, as 'never events.' From AHRQ:

The term "Never Event" was first introduced in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum (NQF), in reference to particularly shocking medical errors (such as wrong-site surgery) that should never occur. Over time, the list has been expanded to signify adverse events that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable.

Further, re: "patient care was never compromised." How do they know that? In fact, this is 'spin' and word games on its face. By definition, if CPOE and chart updating was unavailable, patient care was compromised, where "compromised" means "increased levels of risk for error were created, requiring workarounds."

Further, as mentioned earlier, harms might not show up for some time. Lost orders, corrupted data, errors of omission or commission transcribing backup paper records into the computer ("backloading"), etc. can take their toll later. Post-outage vigilance is essential, putting even more stress on clinicians that increases likelihood of further error and that they certainly do not need. Clinicians are stressed enough already.

Finally:

IT personnel have not only deliberately inserted themselves into clinical affairs (e.g, via the HITECH Act of 2009), they have also done so with a stunning arrogance and unproven braggadocio about their systems "revolutionizing" medicine (whatever that means).

Indeed, they need to accept the medical responsibility and obligations this territorial intrusion entails.

On its face, this massive outage was the result of issues that did not meet accepted professional standards of IT practice for life-critical environments. Res ipsa loquitur.

Something was not vetted properly, there was a lack of redundancy, the IT personnel were NOT in control of their systems.

Just as when physicians don't provide care that meets accepted professional standards of healthcare, this incident and others like it are, by definition, a result of IT malpractice.

If patients are harmed, IT personnel and their management (often non-IT C-level officers) involved in this system need to be held accountable.

If they can't take the clinical heat (as clinicians do daily since the time they enter medical or nursing school), then they need to get out of the clinical kitchen.

-- SS

Note: see this take on these matters at the HIStalk blog:

UPMC’s Cerner systems go down for 14 hours at most campuses last Thursday and Friday, forcing them to go back to paper. The PR person blamed “a database bug,” which makes the above Oracle press release from this past summer a particularly fun read. Cerner and UPMC have an atypical vendor-customer relationship since they’ve invested big money together in innovation projects and UPMC runs a Cerner implementation business overseas.

Now we know who the unnamed "mystery database vendor" is...

-- SS

Dec. 29, 2011 Addendum:

Was UPMC acting as a "proving ground" for some Oracle-Cerner-UPMC experimental health IT technology that resulted in the crash? The claim of being an IT "proving ground" has been made in the past:

Pittsburgh Tribune
May 2, 2006
UPMC partners with technology provider

The University of Pittsburgh Medical Center is taking another step in a quest to commercialize new medical technology.

UPMC on Monday signed a three-year deal with health care information technology provider Cerner Corp. to develop and market medicine-related technological advances. Both parties will contribute $10 million in cash, services and intellectual property to the effort.

The deal is a smaller version of an April 2005 deal between UPMC and information technology behemoth IBM.

As is the case in the IBM deal, UPMC will serve as a built-in proving ground for jointly developed technologies and products, with Cerner marketing the products and UPMC awarded a share of profits.

As I wrote at "Proving Ground for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?":

"A hospital and patients are not a learning lab for HIT vendors. The appropriate "proving ground" for new medical technology is the controlled clinical trial where participants (in this case, patients and healthcare professionals alike) have freedom of choice whether or not to participate, and a chance to give (or deny) consent after being fully informed of potential risk."This is a fundamental human rights issue.
-- SS

Thursday, September 29, 2011

Stroud v. Abington Memorial Hospital: Is This Why Chart Alteration Might Be Appealing?

As I described in several recent posts on malpractice cases at University of Pittsburgh Medical Center (UPMC) including:

"UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence" (link),
and
"Propofol and Other Drug Questions: Was Michael Jackson a UPMC Patient at the Same Time as Samuel Sweet?" (link),

... electronic medical records may offer certain advantages to someone who is going to try to alter medical records.

No whiteout needed, no physical erasures, a difficult to interpret and/or made-hard-to-get audit trail, etc.

Why, one might ask, would a hospital and/or its clinicians attempt such a maneuver, knowing the penalties are likely to be severe?

Because the penalties might not be so severe after all.

While I am not an attorney, this case I came across seems to be readable by those who understand plain English:

ROBERT STROUD, INDIVIDUALLY AND AS ADMINISTRATOR OF THE ESTATE OF JAMES H. STROUD, DECEASED, PLAINTIFF, v. ABINGTON MEMORIAL HOSPITAL, ET AL., DEFENDANTS (link to memorandum opinion).

Here is a summary of what allegedly happened that led to the suit:

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA


... 1. FACTUAL BACKGROUND

James Stroud was admitted to Hospital for a total right knee replacement on October 25, 2004. (Doc. 45 at 11, ¶ 46.) Following surgery, he remained at Hospital under the medical care of various of the defendants and others. (Id. at 11-14, ¶¶ 47-68.) Plaintiff alleges that during that time, James Stroud complained of nausea and failed to have a bowel movement. (See, e.g., id. at 11, ¶¶ 50, 52.) Plaintiff further alleges that, while various of the defendants and others examined and treated James Stroud, they failed to adequately diagnose and treat his emergent medical condition, later found to be a bowel obstruction or ileus. (Id. at 11-14, ¶¶ 51-68.)

Plaintiff specifically contends that Dr. Paul Crispen, a urology resident under the supervision of urologist Dr. Charles ordered an abdominal/pelvic CT scan to be performed on James Stroud on October 28, 2004 to investigate the cause of his lack of bowel movement. (Id. at 12, ¶ 58-59.) Robert Stroud avers that the CT scan revealed "marked dilation of the small and large bowel, representing either an obstruction or adynamic ileus," but that no action was taken in response to this finding of a potentially serious medical condition. (Id. at 14, ¶ 68-69.) Plaintiff attributes this inaction, at least in part, to the failure by the various treating medical professionals to communicate adequately concerning James Stroud's care and the failure by Hospital to have in place and enforce proper policies and procedures for interdepartmental communication. (See, e.g., id. at 19-21, ¶ 105(n), (q), (r), (aa)-(cc).)

That same day that the scan was performed, October 28, 2004, James Stroud was discharged from Hospital to a rehabilitation center. (Id. at 14, ¶ 70.) The following day, October 29, 2004, he complained of abdominal pain and began vomiting. (Id. at 15, ¶ 73.) He was taken to Hospital's emergency room early that afternoon and was subsequently readmitted. (Id. at 15-16, ¶¶ 74-80.) He was examined and additional diagnostic testing, including an abdominal x-ray series, was ordered, completed, and interpreted later that evening. (Id. at 16-17, ¶¶ 81-95.) By about 11:20 p.m. he began vomiting, became unresponsive, and was unable to be revived. (Id. at 17, ¶¶ 96-98.) He was pronounced dead at 12:08 a.m. on October 30, 2004. (Id. at 17, ¶ 98.)


There were allegations of record concealment and withholding and in finding this, the plaintiffs sought additional punitive damages.

The court nonetheless decided (emphases mine):

... Plaintiff's request for punitive damages is premised on two interrelated theories: (1) that the defendants knew that James Stroud was suffering from a life threatening condition, yet failed to take any action in response to that knowledge (Doc. 45 at 59-61, ¶¶ 210-215, 222); and (2) that after the demise of James Stroud, the defendants took actions to cover up their prior negligence, including the deliberate concealment and withholding of relevant medical records (id. at 60-61, ¶¶ 216-221). Plaintiff's underlying substantive claims are, as we know, for negligence, survival, and wrongful death based on the defendants' allegedly negligent care for James Stroud. Plaintiff alleges no underlying claim concerning the defendants' alleged concealment of prior negligence.

This case is thus closely analogous to the case decided by the Pennsylvania Superior Court in Gallagher [v. Temple University Hospital - ed.], which also concerned a medical malpractice action against a hospital. In Gallagher, the Superior Court held:

[Appellants] asserted an independent claim for punitive damages premised upon the allegedly outrageous conduct of altering and withholding the medical records in an attempt to stymie Mr. Gallagher's guardians from successfully obtaining redress for his Injury by tampering with the discovery of the facts necessary for prosecution of his medical malpractice lawsuit. While this conduct is relevant to show after the fact awareness of negligence on the hospital's part, it does not, however, relate to the conduct alleged to have been negligent, which actually caused the injury. While the conduct surrounding the alleged withholding of certain records and the whiting out of portions of other records, if true, is undoubtedly reprehensible, none of these facts, however, relate to the malpractice being litigated. Nor do these facts assert a separate cause of action sounding in tort. 2005 WL 2649868 at *3.

The Third Circuit has similarly held that a defendant's falsification of relevant records and lying at a deposition to conceal his wrongdoing, while reprehensible, is insufficient to establish the culpable mental state of recklessness necessary to impose punitive damages because it does not support the conclusion that the defendant consciously appreciated the risk of the harm he caused. See Burke, 904 F.2d at 183. In so finding, the court reasoned "that punitive damages are intended to deter risky behavior that causes harm; they are not a sanction for obstruction of justice." Id. (citation omitted).


In the Stroud case the court decided and ordered that:

... (3) Moving Defendants' [i.e., hospital and doctors - ed.] motion to dismiss Plaintiff's claim for punitive damages premised on the theory that Moving Defendants "covered up" their prior negligence is GRANTED and Plaintiff's punitive damages claim on this legal theory is DISMISSED WITH PREJUDICE. [That is, it cannot be raised again - ed.]

One might wonder, then, what hospitals and clinicians have to lose, in a malpractice case they believe is likely to be lost on the merits, for records alteration or concealment that they think they might get away with.

There is the Pennsylvania Medical Care Availability and Reduction of Error (MCARE) Act of 2002 (PDF, see Section 511, "Preservation and accuracy of medical records", pg. 18-19). However, how often is that act enforced, even if a separate complaint (which is non-judicial) about records alteration is made to the PA Bureau of Professional and Occupational Affairs (where large medical centers might have sympathetic friends) and to similar bodies in other states?

The camouflage made possible by EMR's would only add to the temptation to try to alter the case outcome through "reprehensible" records alteration and withholding/stonewalling on the production of EMR screen shots, audit trails and other data.

-- SS

Sept. 30, 2011 addendum:

The court's own use of the term "obstruction of justice" suggests another venue for addressing chart alterations besides civil court:

The crime of obstruction of justice, in United States jurisdictions, refers to the crime of interfering with the work of police, investigators, regulatory agencies, prosecutors, or other (usually government) officials.

Specifically, criminal court.

Sept. 30, 2011 addendum #2:

Apparently a memorandum opinion such as the above "Stroud v. Abington Hospital" does not create precedent (link):

A memorandum opinion or memorandum decision is a judicial opinion that does not create precedent, persuasive or mandatory in some jurisdictions. A memorandum is often brief and written only to announce judgment in a particular case. Depending on the kind of memorandum decision, citation of the opinion as case law may not be accepted.

While there are likely other cases addressing the medical record alteration/withholding issue, to my legally ignorant mind [1], perhaps
in addition to criminal charges, "outrageous conduct of altering and withholding the medical records" should be pursued vigorously by plaintiff's attorneys as a basis for punitive damages. This is especially true if the conduct resulted in or contributed to patient harm.

Note:

[1] Perhaps "legal amateur" is a more accurate term in the same way I am a radio amateur or ham (albeit Extra Class) with some technical experience, but not a telecommunications professional who would/should run a mission-critical enterprise telecommunications project -- and in the same way that many in charge of health IT in hospitals are really health IT amateurs with no significant formal training.

-- SS

Wednesday, September 28, 2011

Propofol and Other Drug Questions: Was Michael Jackson a UPMC Patient at the Same Time as Samuel Sweet?

At my Sept. 24, 2011 post "UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence" I wrote a detailed summary of a civil medical malpractice Complaint regarding possible electronic chart alteration. As I pointed out, that Complaint made EMR metadata visible to laypeople for the first time that I am aware.

A new docket has appeared in that case entitled "Interrogatories to Defendant" from Attorney/physician Deborah Maliver dated Sept. 27, 2011.

This document is publicly downloadable from the Pittsburgh Prothonotary Office Civil Docket site at this link, case #GD-09-019407, document #55, or at my cached version at this link (PDF).

It brings up questions of even greater concern to me as a physician, those of mysterious drug orders for powerful sedatives such as propofol, fentanyl and etomidate. Apparently the metadata makes it difficult to account for what could be questioned as "over-generous" dispensing of those drugs.

(This is ironic, since the trial of the doctor who administered this drug to deceased singer Michael Jackson has itself just gotten underway.)

Here is the first interrogatory request listing numerous drugs:


Question 1. Request for full metadata on these drugs (click to enlarge)


See Exhibit "A" from the new Interrogatory docket below, as produced in discovery earlier, and download the new Interrogatory in its entirety to see the questions asked about the other metadata:

Exhibit "A". McKesson drug cabinet dispenser audit trail. Five 100-ml vials of propofol in a row from May 14-May 15? Lorazepam (ativan), propofol and etomidate on May 15-16 at a time when a patient had a deteriorating respiratory status? (These drugs suppress the respiratory drive.) Click to enlarge.


Question 4 is particularly disturbing:

(click to enlarge)


Apparently none of these drugs appeared in the eMAR system, the electronic medication administration record. Where did they go? I hope the full audit trails will show a definitive final disposition of these drugs.

One would hope a highly computerized medical center could keep track of its inventory of drugs of powerful potential for abuse with 100% certainty, chain-of-custody style (that means, 0% guesswork):

Chain of custody (CoC) refers to the chronological documentation or paper trail, showing the seizure, custody, control, transfer, analysis, and disposition of evidence, physical or electronic.

This is of concern to me as a former Occupational Medicine physician (in the transit industry) and a physician in general. I've seen drug abuse result in train wrecks - literally. Drug abuse/failure to be able to track disposition in a hospital would represent a prima facie public health menace.

There are also questions about whether users of the EMR signed in or used the accounts of other individuals, which is another weakness of the EMR. No handwriting to evaluate...

-- SS

10/24/11 Addendum:

Here is a horrible example of what can go wrong when drugs of abuse potential are not tracked with the utmost of rigor:

Star Tribune/Minneapolis

Abbott Northwestern patient left 'writhing in pain' sues

"Hi, love," Sarah May Casareto greeted Larry V. King as he lay on a gurney before surgery. As they wheeled down the hall, he recalled in court records, she told him that he'd have to "man up" because they couldn't give him a lot of medication.

The next 57 minutes of surgery were excruciating, according to a lawsuit filed Tuesday in Hennepin County District Court that accuses the drug-addicted former nurse of skimming his narcotics, which left him "writhing in pain" during a medical procedure for kidney stones last year at a Minneapolis hospital.

Casareto, of Forest Lake, entered an Alford plea of guilty Sept. 1 to a fifth-degree controlled substance crime for possessing Fentanyl, a high-powered painkiller, and was sentenced to probation in connection with the Nov. 8 incident at Abbott Northwestern Hospital. The plea enabled Casareto to maintain her innocence while acknowledging ample evidence to convict her.

The suit, which seeks at least $50,000 in damages, alleges that she was "negligent and careless" in her care for King, 57, of Bloomington. The suit also names Abbott as a defendant.

It contends that Abbott "knew or should have known [before the procedure] that Casareto was exhibiting drug-seeking behavior and that she had become dependent upon narcotic pain medications." It also notes that Abbott officials knew that she had failed "on at least six different occasions" to properly handle patients' pain medication obtained from the hospital pharmacy.

King's attorney, Tony Nemo, called the lawsuit reflective of "a growing problem" that should draw closer scrutiny to drug diversion, or the theft of medications intended for patients.

"One of the things I know Mr. King is hoping is that this case may cause Twin Cities hospitals to reveal procedures and protocols to, if not prevent, at least minimize this problem in the future," he said.

I wonder if information technology problems regarding tracking of drugs with abuse potential existed.

Read the whole article at the above link.

-- SS

Saturday, September 24, 2011

UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence

The world of electronic medical records is very secretive.

Vendors will not allow their programs or data structures to be examined, even by the academic community. Their products, medical devices, are not vetted by regulatory agencies such as the FDA for quality.

Patients and clinical personnel are supposed to take the word of the seller that these systems are fit for purpose and of high quality.

A window into the internal working of EMR's was initiated Down Under just this year, in the form of a detailed internal analysis of an ED EMR product from America slated for roll-out in public hospitals in one of Australia's most populous states. Dr. Jon Patrick of the University of Sydney performed this work. He was not happy with what he found, in terms of software engineering, human computer interaction, and other issues related to fitness for purpose. See here and here.

(For more on healthcare IT difficulties, see "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" at this link: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/.)

One component of the healthcare IT "ecosystem" many have been unable to see, which is perhaps even more carefully guarded than the program code and data structures, is the metadata on EMR use.

A remarkable development has now changed that metadata secrecy - a public civil lawsuit court docket.

Metadata is "data about data." In this context, that means data about who accessed the EMR, what they did, when they did it, from where they did it, etc. Perhaps it should be deliberately misspelled as "meatdata."

It allows the "legible gibberish" (see my Feb. 2011 post "Electronic Medical Records: Two Weeks, Two Reams" for more on that term) produced by the clinical side of EMR to be better weaved into meat, that is, a medical narrative that is essential to truly understanding a case.

I noted the unfortunate case of Samuel Sweet at the University of Pittsburgh Medical Center (UMPC), as reported by Sean Hamill in the Pittsburgh Post-Gazette:

Trial to begin in wrongful death claim
Monday, September 19, 2011
By Sean D. Hamill, Pittsburgh Post-Gazette

As far as Samuel Sweet was concerned, he only had a headache. It was a bad one, but nothing more, maybe something his chiropractor could fix with a little adjustment.

But three days after being admitted to UPMC Presbyterian for what his family was told was a treatable amount of bleeding on the brain, and six hours after his family saw him laughing and chatting about the Penguins' playoff chances, early in the morning of May 16, 2009, Mr. Sweet died unexpectedly.

Why he died is the subject of a civil case his family filed a few months later ... [Plaintiff's attorney] Ms. Maliver [actually Dr. Maliver, as she holds both the JD and MD degrees - ed.] said UPMC's timeline came into question in early August 2011, when UPMC finally turned over -- after two years of discovery [i.e, they turned them over at the last minute, a few weeks before trial was scheduled to begin - ed.] -- 1,200 pages of "results detail sheets" which show not only when something was written in Mr. Sweet's electronic chart, but who wrote it and how.

[The patient died when there was a delay in treatment due to marked difficulty in putting a breathing tube into his lungs (a difficult intubation) when he developed respiratory failure. The defendants possibly never expected someone to actually comb through the 1,200 pages of "results detail sheets" on such a short time frame, but, apparently, the plaintiff's attorney took on the challenge - ed.]


So, for example, Ms. Maliver alleges that the results detail sheets show that during the 21 minutes before Mr. Sweet was said to stop breathing, none of the information in his chart is straight from the computer monitors that would tell what his vital signs were during that period.

But the results detail sheets also show something more troubling, Ms. Maliver said.

She said she found evidence that three days after Mr. Sweet died, Dr. Richard Simmons, UPMC Presbyterian's head of quality assurance, tried to put a "Diff Intub" [difficult to intubate, due to anatomy - ed.] red-letter warning on Mr. Sweet's electronic medical record. That effort showed up on the results details sheets, according to Ms. Maliver.

Such a warning would tell ["alert" would be a more precise term - ed] anyone who opened the record that Mr. Sweet was difficult to intubate.
As a result of this newspaper story, the defendants filed a complaint with the judge, who ordered a six month delay in further proceedings. The complaint and decision is at this link (PDF).

In further investigating what I considered a remarkable story, I came across a public docket Dr. Maliver filed on behalf of her clients in the case, "PLAINTIFF'S MOTION AND SUPPORTING BRIEF TO AMEND COMPLAINT TO SEEK PUNITIVE DAMAGES".

As I mentioned previously, this is a remarkable development that has opened a window on metadata secrecy.

This is freely and publicly downloadable from the Pittsburgh Prothonotary Office Civil Docket site at this link, case #GD-09-019407 , document #40 of 09/02/2011. (I have also cached the document at this link: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/lawsuits/complaint_punitive_damages_vol101400000177.pdf .)

As I mentioned in the aforementioned post, I found the hospital attorney's explanation of apparent tampering somewhat troubling:

Dr. Simmons wasn't trying to alter the record, [attorney for the defendants] Mr. Conti said; instead he was in Mr. Sweet's medical record as part of the "peer review" process, assessing what happened in Mr. Sweet's case.

As part of that, he was in the medical record three days after Mr. Sweet died trying to figure out how one would create a warning about a patient's difficult intubation [in effect, altering the record, at the very least through creation of a confusing audit trail - ed.], Mr. Conti said.

The public nature of the "PLAINTIFF'S MOTION AND SUPPORTING BRIEF TO AMEND COMPLAINT TO SEEK PUNITIVE DAMAGES" document makes it possible for the public to look at some of the actual metadata to see for themselves what might have occurred.

Again, this is remarkable and is the first time I am aware of when the public (and the academic Medical Informatics community, of which I am a part) gets to "peek behind the curtain" of an EMR's metadata.

Let's take a look.

I will summarize relevant part of the Motion and intersperse testimony and metadata from the actual record of Mr. Sweet (again, from a now-public court document).

The purpose of the Motion was to seek punitive damages:

A. SEEKING PUNITIVE DAMAGES

(1) This is a civil action for medical malpractice in which the Plaintiff alleges in essence that Samuel Sweet, a relatively healthy man of only 62 years of age, needlessly suffocated to death in the intensive care unit at UPMC after undergoing a routine cerebral angiogram when, the following day, physicians recklessly and prematurely pulled out his breathing tube and then could not get it back in when it became obvious Mr. Sweet would die without it.

(2) This case is listed for trial on September 19, 2011, and discovery has just concluded.

(3) In light of the evidence adduced in discovery, the Plaintiff seeks to amend the Complaint to re-characterize Defendant Murugan's and Defendant actions and inactions as willful, wanton, reckless and not merely negligent. The Plaintiff similarly seeks to amend the ad damnum clause against these defendants to include a request for punitive damages because of their shocking and reckless disregard for Mr. Sweet's welfare and their attempts to alter the appearance of the medical records, in full awareness of Mr. Sweet's brain death, so as to obscure what really happened.

It is the last part of count A.(3) I will address here, a quite serious charge involving medical record evidence spoliation, which is specifically forbidden in Pennsylvania by the Medical Care Availability and Reduction of Error (MCARE) Act of 2002 (PDF, see Section 511, "Preservation and accuracy of medical records", pg. 18-19) and other regulations.

Of importance, the Motion continues:

... (15) UPMC has a special warning system that is intended to serve the very purpose of alerting all medical providers of a patient with a difficult airway. The way it works [as UMPC defendants testified under oath - ed.] is the attending physician, writes up the problem list for the patient and need only put difficult airway in the list, and this will trigger a special yellow banner to pop up on the patient's computer files for all to see every time the chart is opened and every time any page is viewed.

Not only that, but then the words "difficult airway"appear in red text within the yellow banner, and this puts the viewers on notice to check the anesthesia record as to how intubation was done successfully in the past, so they can replicate the successful technique.

This patient was extubated after a procedure to check for brain bleeding, but by late at night it became obvious he could not breathe adequately on his own, and needed to be re-intubated.

Let's see how a chart appears with, and without the banner about a patient being difficult to intubate (due to their mouth and air-passage anatomy):


Real Electronic Medical Record screen of Mr. Sweet lacking warning banner, above; fictitious chart showing banner, below. [Why wasn't it the fictitious patient chart that was fiddled with? - ed.] Click to enlarge.


Such a warning apparently did not appear in Mr. Sweet's EMR chart, and that along with other failed communication (which can be read in the Motion) led to the re-intubation difficulties, and ultimately death. (I should note that it's possible the clinicians did flag the "difficult intubation" condition, but that the EHR lost the data through relational integrity problems, i.e., the information became "orphaned" from the patient's records, although still existing in the system somewhere.)

(27) ... not one person knew that there was a note from anesthesiology containing a road map for success, that included the use of a "Fast-Track LMA device", neither of which was ever brought in for Mr. Sweet that night when he needed the tube to be put back in.


Exhibit E. Under Oath. "A designation of difficult intubation automatically appears on a patient's banner bar if it is entered as a problem on the Problem List by the user selecting it from a drop-down menu list." (I tend to have doubts the problem list is that intelligent, but this is what was testified.) Click to enlarge.


Sworn testimony indicates nobody took the appropriate actions to enable the alert to appear on the EMR screens:


Admitted under oath. Nobody did what it would take to make a "difficult intubation" alert appear on Mr. Sweet's chart. Click to enlarge.

As a result of this missing data, the "syndrome of overconfidence in computers", and the toxic effect of poorly done health IT impairing clinician-clinician communications, physicians seeing this patient when he was under duress admit under oath they did not know of this intubation problem:


Dr. Kaura didn't know. Click to enlarge.


Dr. Sappington didn't know. Click to enlarge.

This is bad enough. The post-mortem chart fiddling issues I am addressing here begin with this:

C. (39) In the present case, after rounds of complex discovery battles, it became apparent that UPMC altered the records ... in this case, much of the record alteration was conducted by quality assurance officer, one Dr. Richard Simmons.

(40) Once the brain death of Mr. Sweet was known, a wave of record alteration and supplementation occurred, largely though not exclusively at the behest of Dr. Simmons ...

(41) For example, after Mr. Sweet was dead, when it could obviously not benefit his medical care, Dr. Simmons entered Mr. Sweet's computerized medical record, clearly looking into whether there had been a proper yellow-banner warning created through a problem list (which, of course, there was not).

Again, these are serious charges. Why would the plaintiff attorney raise these charges? Let's look at some metadata:


Exhibit K, showing quality assurance officer Dr. Simmons fiddling with Mr. Sweet's chart on May 19th several times during the day, as well as on the 22nd. Note circled entries. Note the gap (labeled) and the time of the last entry on the 19th, 15:23. Also note all these dates are post mortem by several days; death was on the 16th. Also note the times of entry, and the part of the chart accessed in the second round of accesses on May 19th - including "problem list" at 15:02. Click to enlarge.

I note that we are left to wonder what happened between access round two by the QA Officer on May 19 beginning 15:01 PM, and round three on May 22 at 14:03 PM. (Where are data for May 19th after 15:23 and May 20th and 21st, I wonder as well? This was not a weekend but midweek ...)

The Motion continues:

(42) Thereafter, even though Mr. Sweet was now long dead and such action could do him no good, Dr. Simmons tried to create a problem list that had originally been omitted by Defendant. He listed a difficult airway as the problem (even though obviously Mr. Sweet's problem list would have included many things, such as having undergone an angiogram and a minor cerebral bleed). In other words, Dr. Simmons tried to take the action necessary to make the computer show the yellow banner warning that was missing.

Here's more metadata seemingly supporting this statement. It's clear that nobody, including especially someone in Dr. Simmons' role should have been doing ANYTHING to the data that would or could raise suspicion of alterations via the metadata, such as times. Surely a presumably competent senior physician in a peer review role would have known this.

(I also note, shouldn't the record have been electronically "locked" by several days after death, thus causing any changes after the lock to appear in the normal "give us the legal medical record" outputs, not just in metadata?):


Exhibit L. Metadata showing Dr. Simmons on May 19th in the drop-down menu to make a problem list - then retracting it ("active --> cancelled") shortly afterwards. (I note the apparent cancellation time of 3:24 PM, i.e., 15:24, is just after the final May 19th entry of 15:23 on Exhibit K, when the several-day "gap" begins. I also note the patient died on May 16th. Curious... ) Click to enlarge.

But problems apparently occurred:

(43) It did not work. The yellow banner would not appear retroactively onto the otherwise completed record although he did succeed in altering the original record to look like there had always been a problem list. Further, during review of the "detail sheets," the Plaintiff discovered that Dr. Simmons, having failed to create a banner warning, tried to then delete or undo what he had attempted, but could not get it out of the computer tracking system. See Exhibit L hereof.

Let's look at the next part of Exhibit L:


Note the postmortem date of 5/19/2009 on this "problem list", and the attempted cancellation, presented as evidence. Note the time of the Problem list addition - 3:02 PM (i.e., 15:02 as in exhibit K above). Canceled as above at 3:24. Someone in Dr. Simmons' position should not have been fiddling with the problem list, knowing (or should have known, or should have made it his business to know) that footprints of fiddling in the metadata would, at the very least, raise eyebrows. Click to enlarge.

This does not look like the metadata that would be generated by peer review that I myself would perform ...

In summary, this unique Motion containing actual EMR metadata is, in my personal view, suspect for 1) imprudent post-death fiddling with the EMR records at best, and/or 2) attempts to alter the EMR to unjustly protect those who caused harm to come to this patient at worst.

I do not know which occurred, but hospital attorney Conti's excuse that "Dr. Simmons was in the medical record three days after Mr. Sweet died trying to figure out how one would create a warning about a patient's difficult intubation" [that is, entering new data not present before - ed.] could be either:

  • A sign of lack of computer and legal savvy of a senior clinician/UPMC Presbyterian's head of quality assurance, but whose intentions were pure, as explained above; or
  • The confabulations of an attorney caught with his pants down.

My personal opinion?

Want to buy a bridge in Brooklyn, members of the jury and Your Honor?


NY bridge for sale. Cheap.


The following also does not favorably influence my interpretation of the metadata:

(44) It is noteworthy that, prior to producing these results detail sheets that indicated such changes, UPMC attempted to file a motion for a protective order to bring all further discovery to a halt (a motion which was denied) even though the discovery deadline had not yet arrived.

Obviously, this is not for me to decide and will need to await court adjudication, but as a Medical Informatics specialist and someone with some investigative experience regarding computers and medicine, I am not happy with the looks of this.

I report, you decide.

There were other allegations in this plaintiff's Motion, again based on clinical IT metadata, regarding: unaccounted-for drugs of potential abuse (e.g., sedative propofol, the drug that killed Michael Jackson), the entry of fictitious data (such as vital signs, timing and medication administration by others including nurses), dictations coerced out of junior staff by senior personnel that might have been "spun" favorably to the medical center, etc., but those are the subject of later posts.

I again repeat the six-month delay in this case could potentially leave various problems with this EMR system unexposed and unremediated. This could unnecessarily expose the public to six more months of risk.

Addendum: if UPMC or the vendor take issue with posting of this material due to IP or other issues such as health IT gag clauses (which by the way are signed by hospital executives in violation of Joint Commission Safety Standards per my 2009 JAMA letter here and longer essay here), contact the Prothonotary Office in Pittsburgh, not me.

-- SS

Addendum:

What type of person was Mr. Sweet? This type:


Samuel E. Sweet Jr.
Cheswick

Samuel E. Sweet Jr., 62, of Cheswick, died Saturday, May 16, 2009, at UPMC Presbyterian Hospital. He was born Dec. 9, 1946, in New Kensington, son of the late Samuel E. Sweet Sr. and Marjorie (Secrist) Sweet. He was a resident of Cheswick for 33 years. He worked for the Army Corps of Engineers at Lock No. 2 of the Allegheny River and served in the Marine Corps during the Vietnam Era. He was a member of Hoboken Presbyterian Church, Blawnox Sportsmen Club, Blawnox "A" Club and the Springdale VFW. He enjoyed gardening and cutting grass. Survivors include his wife, Janet A. Sweet; sons, Samuel E. "Chip" (Michele) Sweet III, of Natrona, and William E. (Tracy) Sweet, of Edgewood; granddaughters, Kristin Ruff, of South Carolina, and Virginia Sweet, of Natrona; brother, John Thomas (Debbie) Sweet, of Warren; and nieces and nephews. Friends received from 2 to 6 p.m. Monday only, at the THOMAS M. SMITH FUNERAL HOME AND CREMATORY LTD., 930 Center Ave., Blawnox, followed by a funeral service at 7 p.m. in Hoboken Presbyterian Church, 921 North Ave., Blawnox, PA 15238. In lieu of flowers, the family respectfully suggests memorial contributions to Hoboken Presbyterian Church.
-- SS

Addendum:

This case was settled before going to trial for $1,375,000.

-- SS