Friday, September 30, 2011

All The News That's Fit to Print: New York Times Notices UK National Health IT Project Goes "PfffT"

At my Sept. 22, 2011 post "NPfIT Programme goes PfffT" I wrote about the £12.7bn National Programme for IT in the NHS (National Health Service) in the UK being ended after years of delays, technical difficulties, contractual disputes and rising costs. I had predicted this for years.

Now the New York Times has felt this to be News Fit to Print. The NYT may be alone in terms of US coverage of this situation by national newspapers:

September 27, 2011, 7:40 am
Lessons From Britain’s Health Information Technology Fiasco
New York Times
By STEVE LOHR

Government press releases tend to be bland, earnest blather. But not one posted on the British Department of Health’s Web site last Thursday. Its headline: “Dismantling the NHS National Programme for IT.”

To translate the acronyms a bit, the NHS is Britain’s state-run National Health Service and the program in question was the ambitious drive to computerize England’s health records and let doctors, clinics and hospitals share patient information electronically. The project, begun in 2002, was budgeted at £12 billion (about $19 billion) and the government hailed it as “the world’s biggest civil information technology program.

Now, regrettably, it likely holds the honor as the "world's biggest civil IT failure."

The British digital health project has been a slow-motion train wreck for some time with last week’s announcement mainly confirmation — and a pledge to change course. (The announcement was also a political gesture, as the Conservative government of David Cameron tries to get as much distance as it can from an unpopular initiative, begun by Tony Blair’s Labor government.)

I addressed train wrecks at my Jan. 20, 2011 post "Healthcare IT Delirium" and showed this picture and caption, only with respect to our own 'National Program for IT in the HHS':


Running off the rails. We seem to be going out of our way looking for this with HIT, sending it out full speed ahead on far too short a track ...


Back to the NYT:

Yet the United States is about to begin its own government-funded drive to accelerate the adoption of electronic health records, with Washington set to hand out more than $20 billion in incentive payments over the next five years. So what are the lessons to be learned from the English experience?

The lessons are mostly covered in this article:

Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand). Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT. link to pdf

In that article's abstract is nearly all a citizen needs to know:

The majority of information systems developments are
unsuccessful. The larger the development, the more likely
it will be unsuccessful. Despite the persistence of this
problem for decades and the expenditure of vast sums
of money, computer failure has received surprisingly
little attention in the public administration literature.
This article outlines the problems of enthusiasm and
the problems of control, as well as the overwhelming
complexity, that make the failure of large developments
almost inevitable. Rather than the positive view found in
much of the public administration literature, the author
suggests a pessimism when it comes to information systems
development. Aims for information technology should be
modest ones, and in many cases, the risks, uncertainties,
and probability of failure mean that new investments
in technology are not justified. The author argues for a
public official as a recalcitrant, suspicious, and skeptical
adopter of IT. [Irrational exuberance is forbidden! - ed.]


Back to the NYT article again:

I asked three of the best-informed experts on this subject, with firsthand experience in government and health policy: Dr. David J. Brailer, the national coordinator for health information technology in the Bush administration; Dr. David Blumenthal, who held that position in the Obama administration for two years, before recently returning to Harvard; and Richard C. Alvarez, chief executive of the Canada Health Infoway, the nonprofit corporation established to push the adoption of electronic health records in Canada.

Here are some of their comments.

Dr. Brailer on the problem: “What we’re seeing in Britain is the final result of a number of fundamentally bad decisions. … It was classic top-down re-engineering that was forced upon physicians and nurses. The British government treated it as a big procurement program, putting out bids, selecting contractors, picking winners and concentrating their bets. They crushed what had been a pretty vigorous health information technology marketplace in Britain.”

In 2006 or so at a national informatics meeting, I asked David Brailer, then Director of ONCHIT (now ONC) and who I knew from his role prior to that, the question "The UK's NPfIT is having severe difficulties. What are we in the US to do regarding our own program?"

His response: we will learn from their mistakes.

Have we done that? I don't really think so.

... Mr. Alvarez on how Canada and the United States are doing things differently than Britain: “As governments, we’re setting strategy, standards and outcomes in terms of what qualifies as the meaningful use of electronic health records. But we’re not doing the implementation. [Or product selection - ed.] That has to be done at the local level.”

Considering the sorry state of the healthcare IT ecosystem (link), and considering that significant problems in the NPfIT were created through their use of American IT vendors and consultants, that may actually be a mistake, as opposed to picking a product or products and producer that have been vetted by true, unconflicted experts instead of bureaucrats. We may have learned the wrong lessons from the UK's experience.

Another example where we may have learned the wrong lessons:

Dr. Blumenthal on the perils of trying to mandate changes in the work habits of doctors: “In a complex health system, you have an enormous number of independent actors, especially in a system like ours, but in England more than they thought. Physicians and health care professionals have to be part of the process every step of the way. You need to make this a collaborative effort, not a top-down procurement project.”

I believe there has to be a balance of the two: one cannot have pure bottom-up or top-down. It does not work in the setting of a national health IT program. Local politics can be (are?) as bad as, or worse than, national politics.

Dr. Brailer agreed and elaborated: “The experience in Britain is a warning to us. The thing that brought them to their knees was the confrontation with doctors.”

There, I have no arguments, with the additional comment that what also brought them down was this Scott Adams adage:

IGNORING THE ADVICE OF EXPERTS WITHOUT A GOOD REASON

Example: Sure, the experts think you shouldn't ride a bicycle into the eye of a hurricane, but I have my own theory.


-- SS

Oct. 6, 2011 addendum:

Roy Poses opines:

InformaticsMD found that the NY Times has now reported on the "slow motion train wreck" that has been the UK NHS electronic health record project. This brings into the mainstream the notions that electronic health records, and other ballyhooed health care information technology is not a panacea, and that rushing what amounts to medical devices into use before they have been fully developed and adequately tested was not a good idea.

Note that this is not an effort to bash the British. In the US we have not had any obviously better ideas about using health care IT, and much of the technology is shared across countries and marketed by multinational companies. But IMHO, health care IT has been pushed in many countries because it has benefits for big health care organizations:

1) Government agencies (bureaucrats love having numbers to crunch, and health care IT facilitates the use of the guidelines they love to push to show they care about health care quality);

2) Health care insurance companies, non-profit or for-profit (because it facilitates their transactions, and facilitates guidelines as above); but also

3) Drug and device companies (because it allows incorporation of the clinical guidelines they have worked to hard to manipulate to market their products);

4) Hospitals and hospital systems (because it gives their managers more numbers to crunch, and more oversight and power over health care professionals);

5) Not to mention, of course, health care technology corporations.

[I added the numbering - ed.]

In some ways, health care IT benefited from a perfect storm of concordant interests of big health care organizations, but not necessarily from the interests of health care professionals or, most importantly patients. The lesson, again, is that patients' and the public' health, and health care professionals' core values need to take precedence over vested interests of for-profit companies or government agencies.

This taxonomy of why health IT has been pushed is rather predictive of the ills seen with this experimental technology.

-- SS

More Repeats of Talking Points Supporting Making Non-Profit Hospital CEOs Into Millionaires

I have found even more cases of non-profit hospital leaders for whose generous compensation the only support was the usual talking points, without clear evidence on their behalf, and despite obvious concerns based on publicly available data.  In chronological order,

Wellstar

After the firing of its last CEO was later justified by contentions of misconduct and a "special relationship," but countered by accusations of insiders' financial "improprieties," (see this story in the Atlanta Journal Constitution), Wellstar, a non-profit hospital system in Georgia, hired a new CEO, Reynold C Jennings, for hefty price, per the Cherokee Tribune,
He received a five-year contract composed of an initial term of three years and two one-year renewal options.

The contract pays an annual base salary of $975,000, in addition to a bonus that could range from 35 to 65 percent of his annual salary, depending on his performance, [board of trustees chair Randall] Bentley said.

By comparison, Bentley said WellStar’s last CEO, Dr. Greg Simone, earned a base salary last year of $900,000.

Other benefits included in Jennings’ contract are:
Thirty annual paid vacation days, in addition to six holidays.
Payment for time lost from a serious health condition with proper medical certification.
Annual automobile allowance: $12,000.
Annual cell phone allowance: $2,400.
Annual physical exam allowance: $800.
Annual financial planning/tax preparation services: $3,000.
Because Jennings has existing medical and dental coverage and did not want to participate in the benefits plan offered by WellStar, WellStar will also pay him an annual $12,000 allowance for this reason.

The contract also provides for life insurance, a retirement savings plan and long-term disability benefits.

His total compensation thus would have to be more than $1 million, any additional bonus notwithstanding.

The board gave the usual justification for making Mr Jennings a million-dollar plus baby:
'We’re very excited to have someone of his talent and his capability, someone that’s within our community, someone that understands what it takes to take our system to a new level,' said Randall Bentley, chairman of WellStar’s board of trustees. 'We’re very, very excited.'

The WellStar board did not elaborate on Mr Jennings' "talent and capability," or to what "new level" he was expected to take Wellstar. The Cherokee Tribune did note he had a 10 year career in management of Tenet Healthcare, ending in 2007 as Vice Chairman.

Neither the news article nor the board noted Tenet's troubles during Jennings' tenure there, culminating with financial woes and a $395 million settlement of the Redding Medical Center unnecessary heart surgery scandal in 2004 (look here), and a $21 million settlement of US government charges of kickbacks (look here), a $7 million settlement with the government of Florida of charges of fraudulent billing (look here), and a $900 million settlement of federal over-billing complaints (look here, and see our post here), all in 2006.  At least Mr Jennings had experience dealing with allegations of financial improprieties, but if anyone raised questions about hiring someone who lead a for-profit hospital corporation at a time when it seemed steeped in a culture of dubious ethics, they were not reported.

University of California - Davis

The Sacramento Bee noted that:
Last week, UC regents approved a $259,000 raise to $960,000 a year, money paid by hospital fees, not state money or student tuition
for UC Davis Medical Center CEO Ann Madden Rice, justified because,
that another academic hospital was recruiting Rice and offering $1.5 million.

Katehi told The Bee's editorial board today that it was 'not an easy decision' to support the salary hike.

While no one is irreplaceable, she said, the cost and time of replacing Rice would be far greater than the raise.

Just hiring an executive search firm would cost $500,000, Katehi said. Then the search would take a year, and UC Davis would almost certainly end up paying more for Rice's successor. That's just the way the market is, she said.

Rice, the chancellor added, is a great leader.

One wonders whether the decision was informed by Rice's leadership earlier in this year of a lawsuit against the University of California by a group of top university executives who sought a large increase in their pensions at a time that the university was under great fiscal stress (see our post here). That lawsuit drew responses using words like "outrageous," "despicable," and "greed," (not taken out of context) from a variety of people at the university. 

Lifespan

This last story is regrettably local, about Lifespan, the Rhode Island based hospital system, published by the Providence Business News,
A release of Lifespan’s executives’ salary, bonuses and supplemental retirement contributions has been met with great consternation by the Rhode Island Hospital union.

The forms - the U.S. Internal Revenue Service 990 forms for non-profit organizations - show that Lifespan’s nine highest-paid executives received $9.4 million in total compensation in the last reported year, including $1.8 million in bonuses and $2.6 million in supplemental retirement contributions.

Lifespan President and CEO George A. Vecchione received a total of $2.9 million in salary and benefits – including $853,024 in base salary, $522,051 in bonuses, and $1,485,197 in retirement or deferred compensation.

Dr. Timothy J. Babineau, president and CEO of Rhode Island Hospital and The Miriam Hospital, received $1.1 million in salary and benefits – including $573,675, in base salary, $379,376 in bonuses and $92,035 in retirement or deferred compensation.

The defense of these million dollar plus compensation packages was predictable:
Alfred Verrecchia, chairman of Lifespan’s board of directors, said that because of the hospital system’s significant size and complexity, the board places a priority on recruiting and retaining a highly skilled leadership team who can manage in both good and bad times, with the goal of providing the highest quality care to patients. 'The process for setting leadership compensation is undertaken by a board committee and is informed by national surveys provide by the The Hay Group, an independent compensation consultant,' Verrecchia said.

Over the past several years, Verrecchia continued, 'base pay for executives has been relatively flat. A significant portion of the executive pay is at risk and is only paid out if quality, service and financial performance goals established by the compensation committee are achieved.'

Verrecchia praised the current leadership team at Lifespan, saying: 'Lifespan hospitals are fortunate to have a stable, sound leadership team with a proven track record of addressing significant financial challenges in order to continue to fulfill our mission of providing the best and safest care to our patients.'

The system's employees did not all agree:
'We are angry, we feel disrespected,' said Helene Macedo, president of the United Nurses & Allied Professionals which represents 2,200 employees at Rhode Island Hospital.

'It’s not justified, when we see the sacrifice that those of us who are working at the bedside are being asked to make,' she told Providence Business News.

Macedo, an operating room nurse who has been at Rhode Island Hospital for 20 years, was further irked by the fact that Lifespan had just announced a decision to cutting the matching contributions to employee’s 403(b) Fidelity plan for 2011 and eliminating the matching contribution for 2012.

'It looks like another example of corporate greed,' she said, 'when you look at their executives’ salaries, bonuses and supplemental retirement, compared to that of what employees are making – and the sacrifices we’ve been asked to make during the last several years.'

The atmosphere in the hospital, Macedo said, 'is one where we’re counting every penny and cutting every corner. But there doesn’t appear to be any corner-cutting or counting in the corner office.'

Summary

Here were three more examples of million dollar (more or less) non-profit hospital system CEOs. As we have noted frequently, even non-profit hospital systems that are supposed to put their patient care and academic missions, when applicable, first somehow seem increasingly unable to function without yearly making their leaders instant millionaires.

It was striking that the justifications, by boards of trustees or hospital spokespeople, for these indulgent pay packages followed the talking points we have identified before:
-  We pay what everyone else pays
-  CEOs work hard and are brilliant, so they deserve high pay
-  High pay is needed to attract and retain competent, if not brilliant people

Yet in these cases, as in nearly all cases we have discussed before, there were no logical, fact-based arguments why
- the particular CEOs deserved at least what supposedly comparable CEOs got, if not more, and how the comparator group were judged to be comparable;
- why the CEOs were so brilliant, (or in this case, had such "talent and capabilities," was a "great leader," or was "highly skilled," and "stable and sound") when there were at least reasonable but unanswered questions about their leadership based on publicly available information

So despite their hospitals' financial challenges, and despite questions about their previous leadership, more non-profit hospital leaders are becoming million dollar babies, encouraged by boards of trustees who seem to be basing their "stewardship" on the same talking points, rather than reasoned arguments.  One can only wish that the boards who supposedly exercise stewardship over our formerly revered health care institutions actually had to answer some tough questions about the leaders they continue to uncritically endorse.

So ad infinitum, I repeat.... health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior.


If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

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

Do Health Care Leaders Realize They Do Not Practice What They Preach?

When we began Health Care Renewal in late 2004, we focused on "concentration and abuse of power" as a driver of dysfunction in the health system.  We have frequently discussed how problems with the leaders of health care organizations, who may be uninformed, incompetent, self-interested, conflicted, or even corrupt, may be a major cause of rising costs, declining access, and poor quality.  This week, the news reminded us how unsustainable US health care costs have become.  The average cost of health care insurance for those fortunate enough to have it provided by employers exceeded $15,000 last year (look here), a year in which median house-hold income fell under $50,000 (look here).  Yet there is no evidence that the country with the world's most expensive health care has anything approaching the world's best health care. 

From the Harvard Business School, a Call to Rethink Management's Conventional Wisdom

So it was with some hope that I read about a call to change the fundamental beliefs of corporate leaders, particularly corporate health care leaders.  An adjunct faculty member at the august Harvard Business School, Raymond V Gilmartin, posting on the school's blog first summarized the conventional wisdom of corporate leaders:
Most CEOs and corporate board members would agree that the theories and beliefs listed below drive their decision-making on how best to meet the challenges they face:

- The focus of the CEO and the board should be on maximizing shareholder value.
- The stock market is short-term-oriented.
- Stock-based incentive compensation aligns the self-interest of management with shareholders, and a performance-based pay system increases employee motivation.
- Societal concerns should be addressed through corporate social responsibility programs.
- The 'best athlete' from inside or outside the company should be chosen as the successor to the CEO.

In my experience, these beliefs have led managers and boards to take actions that have had unintended, destructive consequences.

Some of these issues seemed to overlap those we have discussed. We have written about the harmful effects of some of these aspects of the conventional wisdom of health care leaders, particularly the perverse incentives supplied by excess executive compensation that seems unrelated to how his or her or the organization's performance affects patients' and the public's health, that health care leaders seem to care little about the organization's health care mission, if they are not actively hostile to it, and that leaders often seem to be chosen because of their perceived ability as generic managers, not their knowledge of health care or their understanding of its values. 

Furthermore, Mr Gilmartin advocated for a new set of guiding beliefs that also were at least somewhat resonant:
Shareholders benefit most when CEOs and boards maximize value for society and act as agents of society rather than shareholders.
Actions to address societal issues should be an integral part of strategy, and operations and should not be isolated as a separate activity under the heading of corporate social responsibility.

Thus Mr Gilmartin seemed to be supporting the notion that health care corporations should focus on providing products and services that actually improve health care, and should operate in ways that support health care's core values.

Also,
Purpose, meaning, and recognition are more powerful motivators than economic self-interest, and large external rewards can reduce intrinsic motivation.

Here Mr Gilmartin seemed to be calling for less extravagant monetary rewards within health care corporations, and perhaps implying that awards should be aligned with health care outcomes and values rather than financial goals.

Did He Practice What He Preached?

Long-time readers of Health Care Renewal know that we often base our arguments about how health care should be renewed on demonstrations of the internal contradictions within the current dysfunctional system. So for those of you wondering if this is one of our rare upbeat posts about the message getting out, it is time to demonstrate the paradoxical aspects of Mr Gilmartin's apparently reformist views.

If you did not recognize his name right away, Mr Gilmartin, besides being a current adjunct faculty member at Harvard, was the CEO and Chairman of Merck from 1994 to 2005 (see here). When he proclaimed his beliefs above, he did not assert they were new revelations, but rather his guiding beliefs since before he became the leader of Merck:
Listed below are an alternative set of beliefs that guided me when I was the CEO of Merck and Becton Dickinson. I strongly feel that they have greater validity, are more effective in meeting today's management challenges, will lead to superior outcomes, and will help restore public faith in business and its leaders.

However, his record as leader of Merck, a record that supplied considerable grist to the Health Care Renewal mill since 2005, stands in stark contrast to these stated beliefs.

CEOs should "maximize value for society and act as agents of society"

Mr Gilmartin presided over what became known as the Vioxx scandal, one so big that it was actually eventually well-documented in medical journals, thus escaping the anechoic effect.

In summary, Vioxx (rofecoxib, Merck) a Cox-2 inhibitor non-steroidal anti-inflammatory drug used for pain, and touted for its ostensibly low risk of gastrointestinal side-effects, was withdrawn from the market in 2004 because of its cardiac risks.  The Vioxx case is flush with examples of how the company used deception to market a very profitable drug without regard to its risks to patients. 

There is evidence is that the company knew about these effects since 2000, but suppressed the clinical research evidence until 2003.(1)  In particular, in 2005, the editors of the New England Journal of Medicine raised concerns that an article published in that journal in 2000 about the results of the VIGOR study of rofecoxib sponsored by Merck failed to report data that would have suggested that the drug caused excess cardiovascular risks.(2) In 2007, the company paid more than $4.9 billion to settle patient lawsuits alleging harm due to Vioxx.(3)  Also in 2008, the company made a $58 million settlement of claims its advertising of Vioxx deceptively minimized its risks.(4) In 2008, it became clear that at least one apparently clinical trial of Vioxx, the ADVANTAGE trial, was merely a "seeding trial,' that is, a marketing exercise.(5)

On Health Care Renewal, we starting writing about Vioxx in 2005, including,
- here about ghost-writing of a Vioxx research publication;
- here, and here about allegations that Merck executives tried to intimidate Vioxx critics;
- here about how advocates of an extreme laissez faire approach to regulation of health care corporations used illogical arguments about the Vioxx case;
- here about the ADVANTAGE "seeding trial," that is, a study really meant to recruit supposed physician-researchers as prescribers; and
- here about how one once prominent Vioxx researcher pleaded guilty to fraud in connection with his research on other drugs.
here about how in settling a shareholder lawsuit Merck vowed to improve its scientific and academic integrity, and refrain from manipulating and suppressing clinical research.

In 2010, we summarized the Vioxx case thus, " the Vioxx case provides a good lesson about some of the tactics used to deceptively and unethically promote health care products (pharmaceuticals in this case)."

The widespread deceptions of the Vioxx case, which likely fooled many patients into taking and physicians into prescribing a drug whose harms greatly outweighed its benefits, seem to be the antithesis of "maximizing value for society."

"Purpose, meaning, and recognition are more powerful motivators than economic self-interest"

Yet Mr Gilmartin embraced compensation that greatly boosted his economic self-interest even as the scope of the Vioxx case became well-known.

In 2005, we noted that Merck CEO and Chairman Raymond V Gilmartin got a 2004 salary of US $1.6 million, plus a $1.4 million bonus, and stock options worth $19.2 million. Also, he exercised other stock options that year, gaining a further $34.8 million.  All this he received soon after the withdrawal of Vioxx, and  despite Merck's stock 30% drop after this withdrawal.

Lack of Insight

We have occasionally discussed evidence that a significant proportion of organizational leaders, including health care leaders, are "snakes in suits," that is, sociopaths who only care about their own self-interest. However, it is likely that the majority of leaders are certainly not sociopathic.

Why, then, do so many health care leaders preside over, if not directly authorize, direct or implement actions they ought to have known were wrong?  The stark contrast between Mr Gilmartin's stated beliefs and the history of Vioxx case which occurred on his watch suggest a failure of insight about his own actions.  He did not seem to realize that what he practiced appeared at odds with the beliefs he now says he espouses.

We constantly hear that our health care organizational leaders, particularly the CEOs of large health care organizations, are the "best and the brightest," especially when their enormous compensation needs justification (for example, look here for a recent example, and here for more.)  A reasonable assumption would be that the "best and the brightest" have some insight into their own actions, and the extent their actions live up to their principles and beliefs.

This new extension of the Vioxx case suggests that an important reason that health care leaders continue to appear ill-informed, incompetent, self-interested, conflicted, or even corrupt is that they lack insight into how their actions might make them seem such. If their mental model of their own actions tells them they well-informed, competent, devoted to the mission of their organization, and honest, regardless of any evidence to the contrary, this faulty insight will allow them to continue actions that make them appear otherwise.

The challenge then is to somehow provide real feedback to health care leaders when their actions appear ill-informed, incompetent, self-interested, conflicted or corrupt. Some reasonable hypotheses would be:
- CEOs and other top leaders must be removed from their bubbles, must relinquish their "imperial" status. They must not be too sheltered from the vicissitudes of daily life, or shielded from criticism or disagreement.
- We must end the perverse incentives that reward CEOs for doing wrong, particularly for making short-term revenue, or even the illusion thereof, their primary benchmark.
In other words, as we have said before, health care leaders must become accountable for what they do, particularly for the effects of what they do on patient's and the public's health.

Maybe if health care leaders can begin to see themselves as others see them, they will start to act to benefit patient's and the public's health, and we might see some improvement in our drastically expensive, inaccessible, and poor quality health care system.

Hat tip to Ed Silverman on the PharmaLot blog.

References


1. Topol EJ. Failing the public health - rofecoxib, Merck and the FDA. N Engl J Med 2004; 351: 1707-1709.  Link here.
2. Curfman GD, Morrisey S, Drazen JM et al.  Expression of concern reaffirmed. N Engl J Med 2006; 354:1193. Link here.
3. Charatan F. Merck to pay $5bn in rofecoxib claims. Brit Med J 2007; 335: 1011. Link here.
4. Charatan F. Merck to pay $58m in settlements over rofecoxib advertising. Brit Med J 2008; 336: 1208-1209. Link here.
5. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE seeding trial: a review of internal documents. Ann Int Med 2008; 149: 251-258. Link here.

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

Monday, September 26, 2011

Using Logical Fallacies to Scold "Pharmascolds"

I first became dimly aware of how dysfunctional health care had become in the US after seeing, up close and personal, a case of attempted suppression of medical research because its content offended vested interests.  (See "Academic Freedom and the Corporate University" by Jennifer Washburn here.)  We have since blogged frequently about suppression of research, other threats to free speech and academic freedom in health care, and the larger anechoic effect, which undermines discussion of many of the threats to core values in health care.

A Case Illustrating "How Academic Orthodoxy is Enforced?"

Thus, I am always on the lookout for new cases which illuminate these issues.  So a recent post on the well-known Forbes blog site by David Shaywitz, identified only as a "contributor," caught my attention:
an elite coterie of self-righteous academics seek not to level the playing field but to dominate it, imposing their particular world view on everyone else. Of course, conservatives, among others, have long alleged this is the true nature of American colleges– where tolerance and open-mindedness is said extend from the left all the way to … the far left. But we now have the opportunity to see this play out at the professional level as well.

This sounds somewhat familiar. The FIRE (Foundation for Individual Rights in Education) web-site boasts a huge case file of attacks on free speech in academia. Most of them did not involve professional schools, or academic medicine in particular. Note, however, that FIRE is avowedly non-partisan, and while many attacks they deplore seemed to be on the free speech of those on the right, quite a few were also on those on the left.

So what was the nature of this illuminating case?
Those who wonder how academic orthodoxy is enforced in practice need look no further than the response to a recent lecture given at Case Western University by Dr. Tom Stossel, the American Cancer Society Professor of Medicine at Harvard, and Director of the Translational Medicine Division of the Brigham and Women’s Hospital, where he is also an attending physician. (Disclosure: Stossel was an academic colleague of mine back when I was in Boston, and we have co-written a number of commentaries over the years; we also coined the term, Pharmascolds.)

Stossel’s lecture, from what I’ve heard, was well-attended — so good for him. But the real news was the three sentence email received by members of the Case Western faculty prior to Stossel’s lecture — a nastygram sent by a colleague at the neighboring Cleveland Clinic.

Subject line: 'Re: Medicine Grand Rounds — Tuesday September 13th' (i.e. Stossel’s talk).

Body of the email (in full): 'This guy is an embarrassment to the medical profession. Can’t believe you would have him provide Grand Rounds. Your trainees deserve better.'

Enforcement or Just Argument?
Unless there is more too it, however, this case would not seem to fit in the category of attempts at suppression of free speech or academic freedom. After all, the folks from FIRE often note that the best response to speech or writing with which one disagrees is more speech or writing. The case above seems to involve two people who disagree, Dr Stossel, and whoever wrote the email. Disagreement is what free speech is all about. Per the FIRE web-site section on free speech:
Freedom of speech is a fundamental American freedom, and nowhere should it be more valued and protected than at America's colleges and universities. The 'marketplace of ideas' upon which a university depends for its intellectual vitality cannot flourish when students or faculty members must fear punishment for expressing views that might be unpopular with the public at large or disfavored by university administrators.

For this case to be an example of someone trying to "enforce academic orthodoxy," there needs to be an action, or at least threat of an action to silence one of these two people, or to punish one of them for what he or she already said.

So I looked for the next part of this case. But there appears to be a problem. There is no more to the case than what appears above:
And there you have it — watch and learn kids! - here’s how A-list academics do it, in three steps and three sentences.

So Mr Shaywitz appeared to be arguing that somehow the email sent about Dr Stossel is a threat to free speech. However, unless the email came from some academic official who could punish Dr Stossel or his audience at Case Western University, the threat to free speech is not apparent.

So we need to find out who wrote the three-sentence email, and whether he or she had the power to enforce his or her opinions as orthodoxy.  Who wrote the email?
The author of this email? Dr. Steven Nissen, perhaps America’s most quoted Pharmascold.

Dr Nissen is Chief of Cardiovascular Medicine at the Cleveland Clinic. Although he appears to have an appointment at the Case Western Reserve Medical School, the chair of cardiovascular medicine there is Dr Dan Simon. Maybe Dr Nissen did not agree with Dr Stossel, but there is no obvious way he could "enforce" his dislike, or otherwise turn it into "orthodoxy."

Dr Stossel's speech may be obnoxious to Dr Nissen. And Dr Nissen's written email may be obnoxious to Dr Stossel, and to Mr Shaywitz. However, neither side has enforced its orthodoxy on, or suppressed the speech of the other.

Logical Fallacies

Relativist Fallacy
If Dr Nissen could enforce orthodoxy by merely writing an email, then Dr Stossel presumably could do so by giving his talk, and Mr Shaywitz could also do so by publishing his post. Implying that only Dr Nissen, with whom Mr Shaywitz disagreed, enforced orthodoxy appears to be an example of the relativist fallacy, the fallacy that a claim may be true for others, but not for the person making it.

Thus the central premise of the blog post appeared to be based on a logical fallacy.  This suggests one should be highly skeptical that the goal of the published work was really the defense of free speech. 

Straw Man Fallacy

It did begin with a paean to free speech that even FIRE staff might like, but then posed an interesting contrast:
When you think about the arguments raised by the Pharmascolds, critics who worry about university/industry interactions, constriction of academic freedom is typically cited as a key concern. To the Pharmascolds, industry represents an inherently corruptive influence on students and trainees, and threatens to impose a restrictive and biased world view upon them.

While this 'Pharmascolds as defenders of academic freedom' narrative has certainly enjoyed considerable traction (likely related to the enabling role of journalists in this dynamic), there’s another competing narrative to consider.

It appears that Mr Shaywitz really does not agree with the "Pharmascolds," a group in which he believes Dr Nissen fits.  Mr Shaywitz did not explain who the Pharmascolds other than Dr Nissen are. He did not provide evidence in support of his summary of their views.  So, at least in this blog post, the Pharmascolds appear to be straw men, and Mr Shaywitz thus appeared to be using the straw man fallacy to support his argument.

A Second Relativist Fallacy

Moreover, Mr Shaywitz did not try to challenge the truth of the "Pharmascolds'" supposed views. Rather, he offered a "competing narrative." That is a surprising form of argumentation for someone who seemed to be appealing to conservatives. The notion that there is no truth, only competing narratives, is straight out of post-modernism, a school of thought with which conservatives rarely identify. Mr Shaywitz's casting of his argument as a better, but still "competing narrative," thus appears to be another use of the relativist fallacy.

So this extraordinary blog post in Forbes appears to be less a reasoned defense of free speech and academic freedom and more an attempt to once again discredit the "Pharmascolds," and hence to discredit anyone who is skeptical of the influence of pharmaceutical companies and other commercial vested interests on academic medicine. But like the last attempt to mock the "Pharmascolds," this one was based on primarily on logical fallacies.

Summary

We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples here, here, and here.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests.
I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts.  While David Shaywtiz was identified only as a "contributor" on his Forbes post, and as an "adjunct scholar" on the version on the American Enterprise Institute site, his profile on the Forbes site notes that he really is Dr David Shaywitz, trained as a "physician-scientist," who now "works at a biopharmaceutical company in San Francisco." His own blog identifies him as "currently Director of Strategic and Commercial Planning at Theravance, a publicly-held drug development company in South San Francisco."  So perhaps Dr Shaywitz disagrees with the "Pharmascolds" because their skepticism may be perceived as threatening the vested interests of Dr Shaywitz's company? Perhaps the campaign against the "Pharmascolds" is yet another example of stealth health policy advocacy by those with vested interests that might be threatened by skepticism about ties among physicians, academic medicine, and industry?

Physicians and the public need to stay extremely skeptical about much of published health policy advocacy, particularly when the arguments appear illogical, or the interests of the advocates are not clear.

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