Another Story of Unaccountable Leadership from UC-Davis: "World Famous" Neurosurgeon Banned from Research, but Still Department Chair

The University of California - Davis just keeps supplying us with lessons about problems with leadership and governance in major health care organizations.

Our latest example comes from a story in the Sacramento (CA) Bee.

A Bizarre Series of Surgical Experiments

It started with two neurosurgeons who embarked on an extremely unorthodox treatment program,

Documents show the surgeons got the consent of three terminally ill patients with malignant brain tumors to introduce bacteria into their open head wounds, under the theory that postoperative infections might prolong their lives. Two of the patients developed sepsis and died, the university later determined.

First,

In 2008, the doctors proposed treating a glioblastoma patient with bacteria applied to an open wound to 'attack the tumor,' then later withholding antibiotics and letting the bacteria do its work.

The FDA responded that animal studies would have to be done before any human research could be considered. Apparently the surgeons intended to do some animal research, but what they did, and what its results were remain unclear. Nevertheless,

Between October 2010 and March 2011, the physicians went forward with three procedures on humans with malignant brain tumors, surgically introducing probiotics into their open head wounds.

One surgeon did get

IRB permission to move forward on Patient No. 1 with a 'one-time procedure' that was 'not associated with any research aim,' the letter states.

University documents show that the physicians believed they had been given the go-ahead for all three surgeries, but officials later determined that they had been misinformed or were misunderstood by the doctors.

No patient lived very long. Two developed sepsis before they died. After hearing that the surgeons were then planning to do the procedure on five more patients,

The university threw on the brakes.

On March 17, 2011, the IRB director ordered the doctors to immediately stop their probiotic treatments, according to university documents.

I should point out that deliberately introducing bacteria into an otherwise sterile surgical site is a very radical and seemingly periolous step. Furthermore, a blog post in Nature News suggests that the reasoning used by the surgeons to support this approach was based on extremely weak evidence,

researchers at the Catholic University of Rome examined the records of 197 patients treated for glioblastoma between 2001 and 2008, of which ten developed pathogenic infections after surgery. Those patients had a median survival rate of 30 months, whereas patients who did not become infected had a median survival rate of 16 months. However, the authors concluded that the association was 'not definitive'. [De Bonis, P. et al. Neurosurgery 69, 864–868 (2011). Link here. ]

A 2009 report considered 382 patients with malignant brain cancer, 18 of whom developed infections. Infected patients lived longer on average, but the difference was not statistically significant. What’s more, the researchers reasoned that infection may correlate with longer survival not because infection prolongs survival but because patients who live longer are more likely to develop infections. [Bohman, L. E. et al. Neurosurgery 64, 828–834 (2009). Link here. ]

The University Investigation

Then,

The internal investigation began.

Six months later, the university concluded its probe – ordering the doctors to halt all human research activity 'except as necessary to protect the safety and welfare of research participants.'

In the case of Patient No. 1, the investigation found, ... [one surgeon] had made an 'incorrect statement' about restrictions on the bacteria's use, leading IRB staff to incorrectly conclude that such review was not necessary, Lewin told the FDA.

As for Patients 2 and 3, the university found that treating them with an 'unapproved biologic' amounted to human-subjects research – and thus required prior review and approval.

The junior neurosurgeon defended their conduct by claiming

We believed that this was innovative treatment, not research, and that IRB approval was not needed

The senior surgeon asserted that he

believed the FDA gave its permission early on, if the doctors thought the treatment was 'beneficial to the patients.' He described the research ban as an "overreaction" by the university.

'And I understand it,' he said. There are people who blatantly break the rules that endanger all of their research programs. We certainly didn't blatantly trample any rules.'

However,

A renowned U.S. bioethicist, describing the alleged violations as 'a major penalty,' said the university's IRB was right to intervene – and quickly.

Arthur Caplan, director of medical ethics at New York University's Langone Medical Center, said that desperate people are especially vulnerable and need added protections.

'If you're dying, you're kind of like reaching out to anything that anybody throws in front of you,' said Caplan

Furthermore, per a Sacramento Bee follow-up article, Elizabeth Woeckner, founder and director of Citizens for Responsible Care and Research, or CIRCARE, said the surgeons' "experiment" was

the worst thing I've seen in my 12 years with CIRCARE

An Overreaction, or an Under reaction?

So far, this story seems different from many of those discussed on Health Care Renewal. The questionable conduct it describes, after all, appears to have resulted in serious negative consequences. Furthermore, it seems to have been conduct by two loose cannons, rather than to be a sign of systemic problems with leadership or governance. However, there is more to the story.

First, the senior surgeon held a substantial leadership position at the time the events in question occurred. He is

[Dr J Paul] Muizelaar, 65, who has been a department chairman at the School of Medicine since 1997

He is pretty well paid, earning

more than $800,000 a year as chairman of the department of neurological surgery

In fact, a companion article in the Sacremento Bee noted,

In 2010 – the same year Dr. J. Paul Muizelaar first performed an experimental treatment on a dying brain cancer patient at UC Davis Medical Center – the neurosurgeon made more money than 99.9 percent of all employees in the University of California system.

With a total compensation package of $801,841 in 2010, he was the 35th highest earner, behind 27 other physicians, four athletic coaches and three executives, according to the most recent UC salary data.

More importantly, even though the university's internal investigation was done in the fall of 2011, and at that time Dr Muizelaar was immediately banned from human research, he did not lose his leadership position. Instead, according to the first Sacramento Bee article,

Despite the disciplinary action imposed last fall, Muizelaar was honored this spring with an additional academic role at UC Davis. He was named the first holder of the Julian R. Youmans endowed chair in the department of neurological surgery, according to an April 19 news release from the UCD School of Medicine.

It is not the first time he has received special treatment. The companion article noted that Dr Muizelaar was able to attain and keep his position even though he never obtained a state medical license,

Muizelaar, who previously was a professor of neurosurgery at Wayne State University in Detroit, was hired directly into the top post at UC Davis – even though he lacked a California medical license.

A native of the Netherlands, where he was educated, Muizelaar was brought into the UC Davis School of Medicine under a 'special faculty permit' issued by the Medical Board of California.

The provisional permit allows a foreign doctor who has been recognized as 'academically eminent' in a specific field to practice at a sponsoring California medical school and its formally affiliated hospitals.

Currently, only 15 doctors at six of California's eight medical schools eligible to receive them hold special faculty permits.

When asked why he never bothered to obtain a California medical license

Muizelaar said he has not gotten a California license because he already works 80 to 100 hours a week and the step is 'not necessary.'

'I'll be frank with you, I'm world famous, so they gave me the license to practice here,' he said. 'I can go sit for the exams, but why would I do that?'

Although Dr Muizelaar continued as department chair and in his endowed professorship for approximately 10 months after he was banned from human research, things happened fast after the stories appeared in the local media. Again according to the Sacramento Bee, three days later, the CEO of the UC-Davis campus, Chancellor Linda P B Katehi

ordered a top campus official to conduct a 'comprehensive review' of accusations that two university neurosurgeons conducted unauthorized research on dying brain cancer patients, as reported in Sunday's Bee.

Ralph J. Hexter, the provost and executive vice chancellor, will lead another investigation into the actions of Dr. J. Paul Muizelaar, the longtime chairman of the department of neurological surgery, and his colleague, Dr. Rudolph J. Schrot, according to a university spokesman.

A day after that, the Sacramento Bee reported,

A UC Davis neurosurgeon accused of performing unauthorized research on humans has 'temporarily relinquished' his position as chairman of the department of neurological surgery, the university confirmed Friday.

However, do not expect to hear much more about this,

A spokeswoman for UC Davis Health System said 'there will be no further system statement on this or other personnel actions.'

Summary: A Culture of Unaccountable Leadership

To sum up, the highly paid chair of neurosurgery at UC-Davis performed bizarre, and potentially dangerous experiments on three patients with terminal cancer, all of whom died, without obtaining permission from the institutional review board. After internal investigation, the chair was banned from performing further human research, but kept his well-paid position, and was given a new endowed professorship.  He only was forced to temporarily step down about nine months later, after reports of the affair appeared in the media. 

So, a la George Orwelll's Animal Farm, doctors may think themselves as equals, but doctors who are health care leaders are more equal than others. After conduct that would likely lead to the dismissal of more ordinary doctors, those who are also in high management positions may just collect more honors.  Then again, Dr Muizelaar considered himself to be "world famous," so why should be be expected to play by the rules under which the common folk labor?

This story also suggests a more general culture of unaccountable leadership at University of California - Davis. Note that the Chancellor who let the neurosurgeon continue in his leadership role despite his strange research conduct and the consequent research ban has appeared in Health Care Renewal before. Specifically, she attained some notoriety last year after campus police who report to her pepper-sprayed unarmed and apparently non-violent students at her own institution who were protesting as part of the "occupy" movement at that time. (See post here.) A later investigation of the incident blamed Chancellor Katehi and her subordinates for "poor decision making," and some editorialists concluded that she showed "incompetence," or worse. Yet Chancellor Katehi retains her top leadership position.

We have discussed how leaders of other health care organizations are rarely held accountable for bad behavior by their organizations. At times, this bad behavior has been criminal, and the leaders' unaccountability has seemed more like impunity.  This seems to parallel a larger phenomenon in society.  Increasingly the wealthy and powerful seem unrestricted by the rules that us common folk are expected to follow.  As Charles Fergusson famously noted on receiving his Oscar,

three years after a horrific financial crisis caused by massive fraud, not a single financial executive has gone to jail and that’s wrong

Health care, particularly in the US, continues to be increasingly expensive and inaccessible, yet its quality appears increasingly dubious. True health care reform would hold health care leaders accountable for upholding the health care mission.

Where is the risk?

That’s the question Thomas Cox, an RN with insurance experience and expertise, says should be asked about any health care financing mechanism.

The whole idea of insurance is distributing risk widely so that it can be shared over a wide group of people and thus become manageable. That’s why people need insurance at all, and that’s also why schemes that put too much of the onus on individuals are a very bad idea – as has happened in recent years to a number of people,  the “insured” individual can incur costs that are more than he or she can bear.

In general, insurance is most solid when it’s over a larger group. Each major increase in group size distributes the risk further and makes the healthcare financing system stronger. Cox has an interesting paper on this which he presented at an American Statistical Association meeting.

In general, large insurers are an order-of-magnitude more sound than small ones, and nationwide insurance systems (such as Medicare) have a distinct actuarial edge over state-based insurance (think, for example, California earthquake). For this reason, it’s a shame that the Affordable Care Act (ACA) has state exchanges as its primary mechanism rather than one single federal exchange; risk dispersal is inferior.

Looking at the risk question, there’s a real problem with affordable care organizations (ACOs), which are one of the primary ways the ACA aims to keep down future costs. Essentially, ACOs are a form of capitation, and (Cox maintains and I think he’s right) capitation is essentially a mechanism to push risks down from the insurer or from Medicare to providers. Pushing risks to smaller groups is a terrible idea and will worsen the system. With ACOs having  smaller covered populations, they are far more subject to being the victim of events they can’t control, whether that’s having a large number of huge-cost, high-needs patients in a single year or having a large number of patients affected by an epidemic or natural disaster.

Providers are not trained or qualified to manage risk well, nor do they have the financial reserves to do so.  Cox calls this “professional caregiver insurance risk.”  Burdening providers with a task they are very ill-suited for is a truly bad idea. As Cox comments:

Pushing risks elsewhere removes the only real function we are paying insurance companies for.  If insurance companies are pushing down their risks elsewhere, we are paying them money for nothing of value. Insurance companies don’t provide healthcare – if they don’t manage risk either, what good are they? Of course, if they can sit there and siphon off profits without taking risks, it may not trouble profit-making insurers . . . but it should trouble the public [if they are] issuing policies, passing the insurance risks on to health care providers, and walking off with guaranteed profits year after year.

And (particularly for the ACO that has been “unlucky” and has incurred larger-than-expected costs), the financial risk can be a force for corruption, pushing organizations toward denying care and undertreatment.

Of course, with the enormous amount of unnecessary care and overtreatment in the US medical system today, some ACOs may indeed manage to give really good care for quite a while provided they are reasonably lucky. But this is a strategy with diminishing returns (as unneeded care dwindles in amount). At root, pushing down insurance risk to smaller entities is, Cox has persuaded me, a fundamentally flawed direction.

And I’ll never look at a health care financing proposal in future without asking myself: “Where is the risk?”

Productive Employment

With desultory interest, I picked up a 1993 novel at the library, The Surgical Arena, by Peter Grant, M.D., “a former navy pilot who became a surgeon.” The following snippet, on page 18, says a lot in a nutshell:

“We’ve got one shot at getting into medical school and that means getting our grades into the top twenty.”

“Why don’t we all just quit and take some gut courses that will prepare us to be brokers,” said Beckwith, one of the veterans. “We can sit on our asses and make a lot of dough.”

“You have to be a crook to be successful in that field,” said Norman. “Besides, you’ll never get any satisfaction out of life unless you put something worthwhile back into it.  I didn’t fight in the infantry to come back and become a broker.”

1993 was the same year that a short-sighted Congress cancelled the Texas supercollider project.  It’s been correctly noted that had that not happened, the recent Higgs-Boson particle observation might have occurred here rather than in Switzerland.  A number of the now-unemployed physicists involved were hired by Wall Street firms.

Although basic banking DOES perform a socially useful function -- firms and individuals DO need capital -- it is very questionable what if anything “banking innovations” (CDOs, derivatives, very rapid short-term computerized trading, etc.) that have proliferated since 1993 have contributed to society.   As Roger Bootle wrote:

For m]uch of what goes on in financial markets . . . [t]he gains to one party reflect the losses to another, and the vast fees and charges racked up in the process end up being paid by Joe Public, since even if he is not directly involved in the deals, he is indirectly through the costs and charges that he pays for goods and services.

In 1995, the assets of the six largest bank holding companies was no more than 17% of GDP, but at the end of 2010, the assets of the six largest bank holding companies were valued at  just over 63 percent of GDP. This financialization of the economy has been at the expense of the rest of us. And finance is now the top area where graduates of Ivy League universities find jobs.

As Dale Carnegie points out, all people – even gangsters like Al Capone – think of themselves as “good guys”.  Lloyd Blankfein, Goldman Sachs’ CEO, is probably sincere when he says he is “doing God’s work”.  But many of us do not agree. Things work as well as they do only because many people are actually still working hard at useful jobs that do contribute to society.  My thanks go to those – and not to the so-called “wealth creators.”

Private Equity vs Patient Care - a Bainful Example

A long investigative report in Salon summarized allegations about the quality of care in various treatment centers owned by Aspen Education, and its parent company, CRC Health Group, in turn wholly owned by a private equity firm, Bain Capital.  The article provides examples of what can go wrong when health care organizations are taken over by remote leadership focused overwhelmingly on short-term revenue.   

A Death from a Treatable Disease
The report opened with the investigation of a 14 year old resident at Youth Care, in Salt Lake City, and Aspen Education treatment center.  Brendan Blum "died of a twisted-bowel infaction," according to the local medical examiner, which allegedly went untreated because "two poorly paid monitors on duty," were slow to seek approval to call for emergency services, and "were too low on the totem pole to call 911 themselves."

The article cited "previously unreported allegations of abuse and neglect in at least 10 CRC residential drug and teen care facilities across the country."  It charged, "such incidents have largely escaped notice because the programs are, thanks to lax state regulations, largely unaccountable." 

Allegations of Toxic Corporate Culture

The article noted numerous other reports of unexplained and allegedly wrongful deaths, and other allegations of mistreatment of patients.

Furthermore, the article noted allegations "that such incidents reflect, in part, a broader corporate culture at Aspen's owner, CRC Health Group, a leading national chain of treatment centers.  Lawsuits and critics have claimed that CRC prizes profits, and the avoidance of outside scrutiny, over the health and safety of its clients." 

We have frequently discussed how the corporate culture of the finance industry, the industry that brought us the global financial collapse/ great recession, has influenced health care, and how this culture may be related to extensive problems with the leadership of health care, including lack of understanding of or even outright hostility to the health care mission, the prioritization of self-interest over the mission, conflicts of interest, and even outright criminal behavior, such as fraud, and kick-backs (bribery).  One way that finance may influence health care is the presence of finance leaders on the boards of trustees of non-profit health care institutions (see recent examples here and here). 

A more direct way the culture of finance can influence health care is for private equity firms (that is, re-branded leveraged buyout firms, look here) to purchase organizations that actually take care of patients.  The Salon article noted:

CRC’s corporate culture, in turn, reflects the attitudes and financial imperatives of Bain Capital, the private equity firm founded by Mitt Romney. (The Romney campaign also did not reply to written questions.) Bain is known for its relentless obsession with maximizing shareholder value and revenues. Indeed, this has become a talking point of late on the Romney campaign trail; he bragged to Fox in late May that '80 percent of them [Bain investments] grew their revenues.' CRC, a fast-growing company then in the lucrative field of drug treatment, was perhaps a natural fit when Bain acquired it for $720 million in 2006. In conversations with staff and patients who spent time at CRC facilities since the takeover, there are suggestions that the Bain approach has had its effects. 'If you look at their daily profit numbers compared to what they charge,' Dana Blum [the mother of the boy who died in the incident discussed above] said of CRC’s Aspen division in 2009, 'it’s obscene.' That point, ironically enough, was underscored by the glowing reports in the trade press about its profitability.

The article discussed how Bain Capital's acquisition of CRC Health Group further tilted the balance towards short-term revenue and away from quality care:

When Bain purchased CRC, it looked like an investment masterstroke. The company, founded in the mid-’90s with a single California treatment facility, the Camp Recovery Center, had quickly grown into the largest chain of for-profit drug and alcohol treatment services in the country, with $230 million in annual revenue. Under Bain’s guidance, its revenue has nearly doubled, to more than $450 million. CRC now serves 30,000 clients daily — mostly opiate addicts — at 140 facilities across 25 states. In the first five years after its acquisition, Bain had already extracted nearly $20 million in management-related fees from the chain, although Bain investors haven’t cashed in yet through dividends or an IPO. Bain’s purchase, a leveraged buyout, also saddled CRC with massive debt of well over $600 million.

According to company executives and independent analysts, hands-on oversight of subsidiary companies is a hallmark of both Bain and CRC. Romney’s campaign literature boasts about Bain taking exactly this sort of direct role in helping to turn around failing companies. 'Over the life of an investment, they have a strong management team willing to participate,' Sheryl Skolnick, an analyst with CRT Capital, a leading institutional brokerage firm, says of Bain.

The CRC acquisition immediately made Bain owner of the largest collection of addiction treatment facilities in the nation. Unlike some Bain Capital acquisitions, which led to massive layoffs, the company’s approach with CRC was to boost revenues by gobbling up other treatment centers, raising fees, and expanding its client base through slick, aggressive marketing, while keeping staffing and other costs relatively low. But that rapid pace of acquisition couldn’t be sustained in the mostly small-scale drug treatment industry alone. So Bain Capital and CRC set their sights on an entirely new treatment arena: the multibillion-dollar 'troubled teen' industry, a burgeoning field of mostly locally owned residential schools and wilderness programs then serving, nationwide, about 100,000 kids facing addiction or emotional or behavioral problems.

One of CRC’s first acquisitions under Bain ownership was the Aspen Education Group. Founded in 1998 with about six schools, Aspen Education had expanded to 30 troubled-teen and weight-loss programs by 2006, including Youth Care of Utah. With Bain’s backing, CRC purchased Aspen for nearly $300 million in the fall of 2006.

Less than a year later, Brendan Blum was dead.

At the time of the CRC acquisition, Aspen already had a history of abuse allegations, including at least three lawsuits, and two known patient deaths, one by suicide. Featured on 'Dr. Phil,' it grew out of schools inspired by the 'tough-love' behavior-modification approach of the discredited Synanon program, which was eventually exposed as a cult. By 2006, Aspen was facing a wrongful death lawsuit, later settled, over an incident in 2004 in which a 14-year-old boy, Matthew Meyer, perished from heat stroke just eight days into his stay at its Lone Star Expeditions wilderness camp in Texas.

This just underscores concerns we raised here about how ownership by private equity could undermine the ability of health care organizations to fulfill their missions. At the time we worried that private equity's short time horizon would clash with health care's long-term focus, how standardized cost-cutting approaches, including emphasis on individual employees' "productivity," could undermine patient care, and how private equity's obsession with secrecy is the antithesis of the transparency required to make health care accountable.

The Increasing Influence of Private Equity

Ironically, the reason that the problems at CRC have gotten such public attention is that the former leader of the private equity firm that controls it is now running for the US presidency. His candidacy emphasizes just how influential the culture of private equity has come.

The purchase of CRC came seven years after [former Massachusets Governor and now Republican presidential hopeful Mitt] Romney publicly announced his retirement as CEO of Bain Capital, where he had been in charge since its founding in 1984. But at the time of his departure, Romney worked out an arrangement to continue to share in Bain’s profits as a limited partner in the firm. Today, he is still an investor in 48 Bain accounts. Though he has refused to disclose their underlying assets, some information about them can be gleaned. For example, he has reported at least $300,000 to $1.2 million, if not more, in fluctuating annual earnings from Bain Capital VIII, the convoluted $3.5 billion array of related funds that owns both name-brand companies such as Dunkin’ Donuts and the lesser-known CRC Health Group. Most of these funds were made more attractive to privileged investors by being registered in the Cayman Islands tax haven. And Romney’s connections to CRC run even deeper: Of the three Bain managing partners who sit on CRC’s board, two, John Connaughton and Steven Barnes (with his wife), gave a total of half a million dollars to Restore Our Future, the super PAC supporting Romney. They also each donated the $2,500 maximum directly to his campaign.

Furthermore, it provides a warning about much more influential it might become, particularly in regard to health care:

Romney has been outspoken about his belief that for-profit health care companies can flourish only without onerous regulations. 'I had the occasion of actually acquiring and trying to build health care businesses,' he said during a primary debate last year. 'I know something about it, and I believe markets work. And what’s wrong with our health care system in America is that government is playing too heavy a role.'

The allegations against one of those health care businesses suggest another viewpoint.

I have frequently repeated a contention that true health care reform would emphasize leadership of health care organizations that understand and uphold the values of health care, starting with prioritizing the needs of patients and the public's health over all other concerns. Instead, there is a danger that health care leaders will be ever more removed from patients and the public, and their health needs, while they become ever more concerned with making as much money as possible in the short-run, and after that, the Devil take the hindmost.

Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems

Another health IT FDA recall notice, this time on middleware, an interface engine that routes data:

Week of July 11

Product description:  

Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange [a specialized computer and accompanying software package - ed.]. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.

Classification:  Class II

Reason For Recall	Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface

The data consists "only" of demographic patient information, schedules, textual information and text reports?

This is a dangerous fault mode, indeed.

"Incomplete information" moving between a hospital information system, imaging systems, a PACS system used to manage the images, and a cardiac cath lab can lead to very bad outcomes (and million dollar lawsuits), such as at "Babies' deaths spotlight safety risks linked to computerized systems", second example.

Note that the interface engine is in release 2.1, level 1, service pack 2.

In other words, a critical hardware/software product such as this undergoes constant tweaking (like Windows).

As a Class II device, at least the software is vetted to some degree by FDA:

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances.^[8][10] In addition to complying with general controls, Class II devices are also subject to special controls.^[10] A few Class II devices are exempt from the premarket notification.^[10] Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance.^[10] Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.^[8][10]

One wonders how testing of tweaks and updates to this product is done, if at all, other than on live and unsuspecting patients.

When you go into the hospital you are not just putting your life in the hands of the doctors and nurses, you're putting your life into the hands of computer geeks and software development experiments.

-- SS

July 25, 2012 Addendum:

The WSJ covered this here:  http://blogs.wsj.com/cio/2012/07/20/philips-recalls-flawed-patient-data-system/.  From their report:

... The problem that led to the recall: hitting the “enter” button, to start a new paragraph, in the summary field of heart test reports, sometimes caused the text entered below that point to be stripped from the report as it was transmitted into the patient’s electronic health record. And doctors later reviewing the patient’s electronic health record would not necessarily know they had received only part of the report, which could lead them to make “incorrect treatment decisions,” Philips said in a letter to hospitals.

...  Mike Davis, managing director at The Advisory Board Company, a healthcare research firm, says in the case of the Xcelera Connect, Philips should have caught the problem in testing. “How the hell does this get out? It shows there wasn’t good quality assurance processes in place.”

Indeed.

-- SS

Vermont: Despite $70 million investment, health IT systems a long way from prime time - "Problems are appropriate"

Preliminary note:  This post is rich with hyperlinks.  At minimum I recommend opening them in another window and at least scanning their contents - SS

No surprises in this article, including an amorality alien to the healing professions, but common in technology circles:

Despite $70 million investment, health IT systems a long way from prime time
VTDigger.org
Andrew Nemethy
July 18, 2012

The state’s efforts to digitize the world of health information, a costly multi-year endeavor that is approaching a $70 million pricetag, got a lousy diagnosis Tuesday.

Instead of creating cost efficiency and improving payment flow to doctors and treatment for patients, it’s creating stress and a lot of headaches for physicians, according to both lawmakers and state officials overseeing the effort. [It's also creating increased risk for patients, a factor - the most crucial factor - rarely mentioned in articles such as this - ed.]

Money, of course, grows on trees, and physicians, hospitals and government have nothing better to do with $70 million than conduct experiments on patients with alpha and beta software ...

There's the usual excuses from the usual actors:

But Health Information Technology (HIT) coordinator Hunt Blair said that’s to be expected considering the difficulty of the “incredibly challenging” task of getting such disparate groups as doctors, hospitals, other health care providers, insurance companies, the state and federal government on the same digital page.

Let alone (per Social Informatics) the organizational and sociological challenges of implementing any new information or communications technology (ICT), that's somewhat akin to saying it's hard to get people to consume arsenic as an aphrodisiac.  Not mentioned is the deplorable state of health IT in terms of quality, safety, usability, unregulated nature etc.

“We’re talking about an extremely complex undertaking and I think it’s important to recognize the state of Vermont was way out in front,” Blair said.

“We’re on the bleeding edge,” he told a legislative Health Care Oversight Committee Tuesday at the Statehouse.

That prompted Sen. Claire Ayer, D-Addison, the panel’s chairwoman, to ask him to clarify if he meant “leading.”

He stuck with “bleeding.”

"Bleeding edge?"

Aside from the very poor choice of terms, this attitude is the polar opposite of the culture of "first, do no harm."  It is not a clinician's attitude.  It is an attitude of someone who seems to forget that patients are at the receiving end of the "bleeding edge" (which usually implies a rocky course) technology:

Bleeding edge technology is a category of technologies incorporating those so new that they could have a high risk of being unreliable and lead adopters to incur greater expense in order to make use of them.  The term bleeding edge was formed as an allusion to the similar terms "leading edge" and "cutting edge". It tends to imply even greater advancement, albeit at an increased risk of "metaphorically cutting until bleeding" because of the unreliability of the software or other technology.The phrase was originally coined in an article entitled "Rumors of the Future and the Digital Circus" by Jack Dale, published in Editor & Publisher Magazine, February 12, 1994.

Wonderful.

Considering the risks to patients, this claim brings to mind the definition I posted of the health IT Ddulite ("Luddite", the common canard against cautious doctors, with the first four letters reversed):

Ddulite:  Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures.

On the other hand, did critic VT Sen. Kevin Mullin read my Drexel website on health IT failure and mismanagement?

That doesn’t surprise Sen. Kevin Mullin, R-Rutland, who had tough questions about the state’s effort to oversee and promote use of electronic medical health records and a statewide health information exchange.

“I hear genuine frustration from providers who are spending time and resources trying to modernize and make their offices more efficient, and prepare for the future, and yet every one of them feels like they’ve been burned,” he said.

“Basically we’re not getting any results for these millions and millions of dollars that have been pumped into IT (information technology),” he said after the meeting.

“We should be a lot further along,” he said. “I just don’t think the leadership’s in place.”

He's on the right track, but I'm not sure Vermont (or any state government) really understands what levels of leadership are truly needed, e.g., as outlined by ONC a few years ago here.

More excuses:

... Mark Larson, commissioner of the Vermont Health Access Department and a former House representative from Burlington, oversees management of Vermont’s publicly funded health insurance programs and the effort on digital medical records and a new medical information exchange.

... Larson told lawmakers he hears the same message they do, that there’s “a lot of confusion in the field.” He said that is an inevitable part of the complex process.

“These are not systems where you just plug that in and they work perfectly on day one,” he said. “Problems are appropriate along the path to get where we want." [I note this is an implicit admission that experimentation is being performed - ed.]


“We just have to work through that,” he said.

"Problems are appropriate?"  ... Really?  In a mission critical field such as medicine?  That's a maddeningly reckless and cavalier ideology, to put it mildly.   In what other safety-critical domain would such a happy-go-lucky attitude that "problems are appropriate", outside of the laboratory, be tolerated? 

"We just have to work through that?" ... "Just work through that?"  Really?

That should be really easy,  just like the failed £12.7bn (~ US $20 billion) National Programme for IT (NPfIT) in the NHS, a program that went "Pffft" last year.

... Based on testimony Tuesday, the issues that medical practitioners and the industry face in digitizing information are familiar ones for anyone who deals with technology: Software that is problematic, digital files that don’t translate and can’t be read by other systems, lost time spent on technological issues that detract from what doctors are paid to do, which is treat their patients. [And create increased risk that leads to maimed or dead patients - ed.]

"Familiar to anyone who deals with technology?"  As in, say, mercantile/management computing that runs Walmart's stock inventory system, or the Post Office?  Is that an appeal to common practice of some type?  This brings to life my observation that there is an utter lack of recognition (either due to ignorance, or opportunism) that HIT systems are not business management systems that happen to be used by clinicians, they are virtual clinical tools (with all that implies) that happen to reside on computers.

How utterly amoral and alien to the ethics of medicine these attitudes are.  No regulation of the technology is in place.  No systematic postmarket surveillance of patient harm or death is conducted. 

Further, the literature on health IT is not entirely as optimistic and tolerant as the VT government.

Is the VT government aware of that literature?

Just a few specific examples - the National Research Council wrote that  "Current Approaches to U.S. Healthcare Information Technology are Insufficient", do not support clinician cognitive processes (then what, exactly, is health IT supposed to do?) and may result in harm. 

The ECRI Institute indicates health IT systems are among the top ten technology risks in healthcare.

Reports from the Joint Commission, FDA and AHRQ indicate that risk is known, but magnitude of risk unknown ("tip of the iceberg" per FDA).

A report from NIST indicates that usability is lacking and promotes "use error" (technology-promoted error, as opposed to "user error").

A report from IOM on safety of health IT states that:

... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”).

The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.

(Institute of Medicine, 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. PDF.  Washington, DC: The National Academies Press, pg. S-2.)

Human subjects protections?  Not needed here ... it's just one big, unconsented, happy $70 million medical experiment.

What is not mentioned, and either deliberately ignored or lost on these politicians, is the effects of this turmoil on patient care in terms of risk and adverse outcomes, and that being on the "bleeding edge" in this experimental technology is not desirable.  

Slow, skeptical and cautious approaches are essential.  Physician education on health IT risks and patient informed consent might be nice, too.

It seems mass social re-engineering experiments are fine, even if the consequences include wasted resources the healthcare delivery system can ill afford, physicians being distracted by major defects, and outcomes like baby deaths, adults suffocating at the bedside, and graveyards.

-- SS

Steward Health Care vs Rhode Island Blue Cross Blue Shield: How Public Relations Twists the Narrative

Negotiations between a local RI hospital system and the largest RI health insurer have now become very public. An advertising campaign by the larger hospital system that is set to absorb our local one provides lessons on how important health care policy issues are publicly discussed.

Simplified Background

Landmark Medical Center is a small health care system in northern Rhode Island.  It has been in financial difficulty, and hence management negotiated a buyout  [see comment of 19 July, 2012 below] while in receivership a buyout was negotiated.  It is now in the process of being acquired by Steward Health Care, a regional hospital system based in Massachusetts (summarized here and here).  Meanwhile, Landmark has been in negotiations with Rhode Island Blue Cross Blue Shield, the largest RI health insurance company.  The negotiations have not been going well, so RI BCBS notified its policy-holders that it is possible Landmark will not be in its network in the future.  This difficult negotiation prompted Steward Health Care to make the discussion more public.

The Steward Health Care Advertisements

Steward Health Care has run a series of full-page advertisements in the Providence Journal.  One advertisement that has run at least three times, by my count, includes the following text:

WHAT KIND OF CHARITABLE ORGANIZATION SPENDS $120 MILLION ON ITS HEADQUARTERS
BUT DENIES SERVICES TO ITS POOREST COMMUNITIES?

Blue Cross & Blue Shield of Rhode Island is designated as a "charitable organization." But they certainly don't spend like one. They invested a small fortune on their opulent corporate offices in Providence. They dish out million each year in executive salaries. And for all that exorbitant spending, they pay absolutely nothing in Rhode Island state taxes.

Then, in May of this year, they refused to give Landmark Medical Center in Woonsocket a long-term contract without Steward Health Care participating. Steward, trying to be helpful, proposed base rates that were 5% below the state median, quality metrics used by the federal government, and a commitment to payment reform. But suddenly, the coffers had run dry. Blue Cross refused to even discuss the proposal.

Instead, they issued their response: Terminate Landmark Medical Center.

Never mind the residents who would lose their only hospital, the employees who would lose their jobs, or the elderly who would have to travel for care. Blue Cross was only interested in protecting the one group they serve most effectively, themselves.

This pretty plainly was a David vs Goliath narrative, with poor, small Landmark Medical Center and Steward Health Care, whose only goals were to serve local residents, as David, and huge, wealthy Blue Cross Blue Shield of RI, whose only goal is allegedly to serve its executives' interest, as Goliath.

Given that we have frequently discussed how self-interested, over-compensated executives may fail to uphold, or may even undermine their health care organizations' missions, this seemed like a narrative primed for further discussion on Health Care Renewal. In addition, Blue Cross Blue Shield of Rhode Island was beset by a scandal before we began Health Care Renewal (look here), involving allegations of excess compensation given to and conflicts of interest affecting its CEO.

Blue Cross Blue Shield of RI: Executive Compensation, Budget and Taxes

In fact, the most recent figures made public by RI BCBS on executive compensation showed that CEO Peter Andruszkiewicz was offered total compensation of $600,000 a year when he started in 2011 (look here.)  Also, as suggested by the advertisement above, there has been considerable local controversy about the size, scale, and price of the new RI BCBS headquarters (e.g., here).   Apparently, however, Blue Cross Blue Shield of Rhode Island does pay state taxes (per this report).

On the other hand, keep in mind that RI BCBS is one of the few health insurance companies to provide community (age-adjusted only) rated individual health insurance even for people with pre-existing conditions, (look here) at the behest of state law, to be sure. So perhaps RI BCBS is not quite the ogre oppressing the poor that the advertisement implies it to be.

But wait, there is more. This all started as a contract negotiation between a health insurer and a local hospital system which is about to be acquired by a regional hospital system. If Steward Health Care saw fit to bring up the executive compensation practices, budget, and taxes of Blue Cross Blue Shield of Rhode Island as relevant to the dispute, might Steward Health Care's executive compensation practices, budget, and taxes also be relevant?

Steward Health Care and Cerberus Capital Management: Executive Compensation, Budget, and Taxes

The problem is that we know very little about Steward Health Care's executive compensation practices, budget, and taxes. While the advertisement above (and Steward's own web address, steward.org) imply that Steward is only about providing health care to the poor and needy, and perhaps that Steward, like Rhode Island BCBS, is non-profit, neither is quite true.

In fact, Steward Health Care is the new name for what was once Caritas Christi Health Care, formerly a Catholic non-profit health system that was acquired in 2010 by Cerberus Capital Management, a private equity firm (look here).

Private equity firms are notably secretive. Neither Cerberus, nor its new health care acquisition, has seen fit to publish any details about executive compensation practices, budgets, or taxes.

We do have a few clues, however.

Executive Compensation
Caritas Christi at the time it was acquired by Cerberus was lead by CEO Ralph de la Torre.  His compensation in 2009 prior to the acquisition was $2.2 million a year.  He is still leading Steward Health Care. It is reasonable to expect that his compensation is not less than it was before, and probably more (look here).  It is reasonable to guess that Dr de la Torre's total compensation is currently several times larger than that of the BCBS of RI CEO. 

The leadership of Cerberus Capital Management includes, according to its web-site, John W Snow, chairman and senior managing director.  Mr Snow, former Secretary of the US Treasury, was listed in 2009 on the Virginia 100 web-site as having a net worth of approximately $90 million, although not with much confidence in the precision of the figure.  He is also a director of the Marathon Petroleum Corporation, from which he received $300,000 in compensation in 2011, according to the company's proxy statement, and of Amerigroup, from which he received at least $170,000 in equities, and additional amounts in fees and deferred compensation in 2011, per that company's proxy statement.  Stephen A Feinberg, founder, CEO, and senior managing director, described as a "recluse" in the New York Times, was listed as number 21 on a list of the 25 most powerful businessmen in 2007 by Fortune, at that time running through Cerberus 50 companies with total revenues of $120 billion.  On Wikipedia, his net worth was estimated as $2 billion in 2008.  These figures suggest that leaders of Cerberus Capital Management can make very large amounts of money, orders of magnitude larger than the compensation of the BCBS of RI CEO.

Budget
There is little public information on the budget of Cerberus Capital Management, but note again the estimate above that in 2007, it controlled 50 companies with $120 billion in revenues.  There is also little public information about the budget of its subsidiary, Steward Health Care.  Estimates from a recent article in Commonwealth suggested that Cerberus invested $251.5 million in Steward, but that Steward's 2011 budget had a net loss of $57 million.  According to the Woonsocket Call, an apparently short-term balance sheet from March 31, 2012 showed that Steward Health Care had assets of $1.1279 billion, liabilities of $1.0259 billion, and stockholder equity of $102 million.

Taxes
There seems to be no significant public information on taxes paid by Steward Health Care or Cerberus Capital Management.  According to Chareles Ferguson in Predator Nation, Cerberus chairman John W Snow resigned as Treasury Secretary "in 2006 only because it was revealed that he had not paid any taxes on $24 million in income from CSX, which had forgiven Snow's repayment of a gigantic loan that the company had made to him."

So while RI BCBS can be faulted for paying relatively high executive compensation, using its funds to build a rather lavish headquarters building, but not for failing to pay RI taxes, at least all these have been issues for public discussion. Furthermore, Cerberus Capital Management, and Steward Health Care which is its creature, while explicitly bringing these issues into the public debate about the Landmark negotiation with Blue Cross Blue Shield of RI, have not seen fit to reveal their own executive compensation, budget, or taxes. There is reason to think that their executive compensation and management budgets could be far more bloated that those of RI BCBS. We have no idea whether they have paid what might be considered their fair share of taxes, but note that their current chairman has had issues in the past with his personal tax payments.

Summary

The vigorous advertising/ public relations campaign by Landmark Medical Center, Steward Health Care, and ultimately Cerberus Capital Management to get a more successful outcome of the negotiation between Landmark and RI BCBS seems to be an example of the tactics used in support of the public relations by large, for-profit health care organizations. In the absence of any transparency about the executive compensation, budget, and tax payments by Cerberus Capital Management and its subsidiary, Steward Health Care, lavish public advertising faulting the executive compensation, budget, and tax payments of its counter-party suggests a rather crude attempt to twist the narrative so as to divert public attention from relevant issues.

If this was not the intention, perhaps Cerberus and Steward will make their executive compensation, budgets, and tax returns fully transparent?  We wait with bated breath.

In the absence of such transparency, skepticism about their public discourse remains warranted.

There is more and more public discussion of health policy from the local to the global levels. Much of this discussion, like much political discussion in general, seems dominated by expensive public relations efforts on behalf of the richer health care organizations. Physicians, other health care professionals, health policy researchers and leaders, and the public at large should be alert to the possibility that these communications will use psychological manipulation to divert its narratives in directions favored by these large health care organizations. Anyone listening or viewing communications coming out of such public relations efforts ought to consciously think about the relevant facts and issues they ignore, and why they may have been consciously omitted.

University of Virginia, GE settle $47M suit over EMR implementation

The following Keystone Kops story of healthcare IT dysfunction brings to life (like the old GE slogan) the types of mismanagement I've written about at my site "Common Examples of Healthcare IT Difficulties":

From 1982 GE commercial - "We Bring Good Things to Life"

Clown pun not intentional - but perhaps apropos, not just with reference to GE but to U. Va's health IT leadership team as well.  It seems both parties might have had a role in this debacle (see additional links in the article below).

University of Virginia, GE settle $47M suit over EMR implementation

FierceEMR.com
July 13, 2012

By Dan Bowman

The University of Virginia this week reportedly has settled a $47 million civil suit against GE Healthcare over what it believes was sloppy--and ultimately incomplete--development and implementation of an electronic medical record system. The case, which originally was filed in 2009, had been set to go to trial this week. When FierceHealthIT checked on Friday, the case had yet to be entered into the circuit court clerk's records. In 1999, UVa hired IDX Systems Corporation to develop an integrated healthcare information management system, according to The Daily Progress. Amendments to the contract in 2002 divided the project into four phases, with the first two focusing on implementation of the records management software, and the last two focusing on billing and logistics. After acquiring IDX in 2006, GE was tasked with hitting the milestones outlined through Phase 2 by June 2008; UVa claims it never did, and in February 2009 asked for a refund of more than $20 million. At that time, UVa also awarded a $60 million contract to Epic to perform the same tasks, according to C-Ville.com [see note 1]. GE swiped back, blaming UVa for the delays in implementation, and saying that by going with Epic, the school "failed to perform its obligations under the agreement, breaching its contract," according to a filing obtained by the Daily Progress. The case isn't too surprising, considering that GE Healthcare has had issues since purchasing IDX. In a KLAS report from August 2010, author Kent Gale said there was a "downward trend in GE's meeting commitments" to its customers. Besides what was undoubtedly a huge waste of money and resources, what is missing from this story is the possible impact of this debacle on patient care.  Not "hitting the milestones" of phase 1 and 2 ("focusing on implementation of the records management software") and peforming "sloppy and incomplete" work can probably be translated as having had "bull in a china shop" effects on records management. Perhaps the morbidity and mortality rates at U. Va during the period of EHR mayhem need to be examined. -- SS Notes: [1] From the link to C-Ville.com:  "According to UVA’s complaint, the deal dates to 1999, when UVA contracted with tech firm IDX to develop an electronic medical record system, or EMR, for its hospital. But problems started early, UVA claimed, with IDX failing to hit milestones on the multi-phase project. When technology company GE took over IDX in 2006, the parties got together to rework the contract. But UVA said the issues continued, and it ultimately pulled the plug, saying GE failed to meet its obligations. GE, meanwhile, claimed it was UVA that broke contract. The two parties had agreed to work together on the complicated project, according to the company’s counterclaim. UVA was to act as a development partner, collecting and processing two decades’ worth of patient data and building and testing the system. But the medical center didn’t hold up its end of the bargain, said GE, making it impossible for the company to stay on schedule."

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Did Toxic Effects of an EHR Kill Rory Staunton?

A stunning story about the death of a young man from sepsis (blood poisoning by infection), missed in an ED, appeared in the New York Times:

An Infection, Unnoticed, Turns Unstoppable

By JIM DWYER
New York Times
Published: July 11, 2012

For a moment, an emergency room doctor stepped away from the scrum of people working on Rory Staunton, 12, and spoke to his parents.

“Your son is seriously ill,” the doctor said.

“How seriously?” Rory’s mother, Orlaith Staunton, asked.

The doctor paused.

“Gravely ill,” he said.

How could that be?

Two days earlier, diving for a basketball at his school gym, Rory had cut his arm. He arrived at his pediatrician’s office the next day, Thursday, March 29, vomiting, feverish and with pain in his leg. He was sent to the emergency room at NYU Langone Medical Center. The doctors agreed: He was suffering from an upset stomach and dehydration. He was given fluids, told to take Tylenol, and sent home.

Partially camouflaged by ordinary childhood woes, Rory’s condition was, in fact, already dire. Bacteria had gotten into his blood, probably through the cut on his arm. He was sliding into a septic crisis, an avalanche of immune responses to infection from which he would not escape. On April 1, three nights after he was sent home from the emergency room, he died in the intensive care unit. The cause was severe septic shock brought on by the infection, hospital records say. 

Rory Staunton, age 12, 5 feet 9 inches tall and 169 pounds, had suffered a cut on his arm.  He presented with a marked fever of 102 F (39 C), pulse markedly elevated at 131, respiratory rate elevated at 22; reported to have hit as high as 36 breaths per minute (in essence, panting).  It was reported by the NYT that before the ED visit his parents said his temperature had reached 104 F (40 C).

That alone should have set off some level of concern.  (It is possible narrative details of his history never made it into the ED chart; ED EHR's are often templated point-and-click affairs that can impair or discourage capture of narrative.)

Per the NYT, the bacteria Streptococcus pyogenes normally dwells in the throat or on the skin, areas where the body is well defended.  Also known as Group A streptococcus, the strain typically causes strep throat or impetigo.  However, if it gets into the blood stream (e.g., via a cut in the skin, as this patient suffered playing ball), the results can be devastating.

The lab results from the first ED visit are particularly stunning:

(From NYT article; click to enlarge)

The white blood cell count is markedly elevated at 14.7, meaning 14,700 cells per microliter of blood (cubic millimeter or 1 mm³).  Further, there is a plain evidence of greatly accelerated new white cell production, in the form of "bands", at 53% of the total (normally 5-15%).  Bands are immature white blood cells that are seen in the blood, being produced as part of the body's response to infection.

Herein is a significant issue.  The NYT noted that:

"Three hours later [i.e., after the ED visit, which reportedly only lasted 2 hours - ed.], Rory’s blood tests came back. High levels of neutrophils and “bands” – immature white blood cells – are evidence of infection. But nobody called the Stauntons, and by the time Rory returned to the hospital the next day, his infection was unstoppable. He died two days later."

Not getting into the issue regarding the patient apparently being discharged before the labs got back (itself an invitation to disaster), and the other abnormalities such as low sodium, low platelets, elevated glucose all pointing to a very sick patient... nobody called the Stantons with white cell results like these?   Nobody entertained the thought of ... antibiotics as a precaution?

It is possible - dare I say likely - that no clinical person in the ED ever saw these results.

EHR's that are poorly designed or implemented can have a toxic effect on care.  For instance, EHR's can cause user confusion if the user interface is complex, data can be lost due to poor relational design.  Data from the wrong patient's data can be presented (misidentification), or data from a lab can come back to the system after a patient has left, and despite being abnormal, just sit there in a silo without being looked at ("out of sight, out of mind"; a "silent silo" syndrome).

It is usually difficult to ascertain exactly which EHR product is being used at a particular hospital.  I note this medical center actively promoted its EPIC EHR in a June 2011 press release "NYU Langone Medical Center Launches Next Phase of Its Electronic Health Record System", although another system "ICIS"  (for Integrated Clinical Information System, "a state-of-the-art healthcare information management system that connects all NYULMC caregivers involved in patient care") is mentioned here.  The ICIS may also contain the Eclipsys Sunrise Clinical Manager, per this link. (I'd noted some clinically relevant problems with the latter in an FDA report here.)

In any case, magical powers are attributed to the technology that are not strongly or uniformly supported by the literature (link), but strongly pushed by industry marketing memes of deterministic health IT benefits and absolute beneficence:

“... Our electronic health record system is an integral part of our ongoing efforts to leverage technology and enhance our ability to provide patient-centered care and enable the highest level of quality care management,” said Bernard A. Birnbaum, MD, senior vice president and vice dean, chief of hospital operations at NYU Langone. “These front-end and back-end services are an important step in assuring our patient’s experience from beginning to end is a seamless one.”

I've documented examples of situations where EHR's and other IT components of clinical ERP systems (enterprise resource planning and management systems, a term that more accurately describes what exists in many hospitals now than the misleading, file cabinet-evoking term "EHR") contributed to or caused patient harm, such as at "Babies' deaths spotlight safety risks linked to computerized systems" - a computer error caused a central line placement x-ray to have gone unread, leading to death; "The Sweet death that wasn't very sweet" - a missing "difficult intubation" EHR flag led to a middle-aged man suffocating during an intubation attempt; and others.  An Australian researcher thoroughly studied the potential risks of an EHR meant specifically for ED's ("A Study of an Enterprise Health information System", PDF executive summary at this link).

The following passage in the NYT article also offers another clue:

... Two hours later, though, he had three [signs of sepsis]: his temperature had risen to 102, his pulse was 131 and his respiration rate was 22. But by the time those vital signs were recorded, at 9:26 p.m., they had no bearing on his treatment. In fact, the doctor had already decided that Rory was going home. Rory’s “ExitCare” instructions, signed by his father, were printed 12 minutes before those readings. 

Did those readings escape notice due to delayed charting (data entry), a common problem with EHRs in busy clinical environments?

The Institute of Medicine in its 2011 IOM report on health IT safety admitted harms are reported but the magnitude of harms is unknown due to multiple reporting impediments, as did the FDA in its 2010 internal memo on "H-IT Safety Issues" divulged by the Huffington Post Investigative Fund (see here and here).  The National Institute of Standards and Technology (NIST) admits in its 2011 report on HIT usability that EHR usability is often poor and may lead to "use error" (error caused or promoted by poor design, as distinguished from simple user error, see here), magnitude of problem also unknown.

In a startling medical situation such as Rory Stanton's, where crucial labs seem to have evaporated causing or contributing to delayed treatment of a devastating and obvious illness, I believe EHR-related factors need to be examined and ruled out first.

For, quite simply, if the EHR caused or contributed to this tragic debacle, the public could be at risk.


-- SS

Additional thought:  could this be the "cybernetic Libby Zion case" I've written of?

-- SS

July 18, 2012 Addendum:

The Stauntons, who appeared on the NBC Today Show are seeking to create a “Rory’s Law” in New York to ensure that parents have full access to blood and lab tests done on their children as soon as results are available, and that a doctor will be present to assess the findings. Story here.

-- SS

Quantitating the Corruption of Finance Leadership (Who May Overlap with Health Care Leadership)

The bad leadership in health care that we frequently discuss now appears to exist in a context of an increasingly corrupt society.  In particular, we have discussed how the leadership of major health care organizations, such as teaching hospitals, and the universities within which medical schools operate, now frequently interlocks with the leadership of finance.  The ongoing global financial problems have been blamed on bad leadership in finance.

A Survey of Finance Leaders

Now, a survey by a law firm that supports corporate whistleblowers offers some quantitation of the corruption within finance.  The press release for the survey is here, and a summary of results is here.  The survey respondents were 250 US based, and 250 UK based "senior individuals within the financial services industry."

Key results were:

- 24% of those surveyed believed that the rules may have to be broken in order to be successful.

- 25% of UK respondents believed financial services professionals may need to engage in unethical or illegal activity to get ahead; US respondents were only slightly less inclined to engage in wrongdoing at 22%.

- 12% of total respondents believed that it was likely that staff in their company have engaged in unethical or illegal activity in order to be successful.

Perhaps exhibiting ego bias, the senior professionals thought that there competitors were even worse:

39% of total respondents believed it was likely that their competitors have engaged in illegal or unethical activity in order to be successful.

A substantial number of respondents admitted that they would be willing to engage in illegal activity were the circumstances favorable:

16% of total respondents were at least fairly likely to engage in insider trading if they could get away with it. Perhaps more troubling, only 55% of all respondents could say definitively that they would not engage in insider trading if they could make $10 million with no risk of getting arrested.

An important fraction thought that the worked within organizations that encouraged unethical and illegal behavior:

- 30% of all financial services professionals reported feeling pressure to compromise ethical standards or violate the law as a result of their compensation or bonus plan.

- In assessing other pressures that may lead to unethical or illegal conduct, 23% of all respondents also reported feeling other pressures to compromise ethical standards or violate the law.

Note that due to social desirability bias, the survey likely understates these problems.

Comment

Also note that at least so far, this survey is not much less anechoic than much of the evidence of corruption in health care that we have discussed. Although it has been briefly noted in the financial blogs and press, like Reuters, BusinessWeek, and also in the New York Daily News and Los Angeles Times, no other main-stream media has commented yet.

One post on a Forbes blog by Peter Cohan made the weary observation:

Business corruption follows a well-worn path. The boss tells you to bend the rules, and knowing that ignoring that request will cost you your job, you do what you’re told. At the end of the year you get a big bonus and promotion.

Then a disgruntled customer or employee leaks the shady activity to the press or a regulator and your company pays a fine and gets a few weeks of bad headlines. Time passes and the cycle restarts.

He concluded in part:

The conditions that make business corruption pay off have not changed despite numerous scandals — recent ones include Enron, WorldCom, Madoff, and Lehman Brothers – all of which reflect the same conditions that prompted me to write Value Leadership a decade ago: Let executives write their own report cards, base bonuses on those numbers and you will get corruption every time.

The solution is as clear to me as it is impossible to implement. First, all corporate financial reporting must be conducted by highly paid government auditors –rather than by auditing firms that are paid by the companies they audit. Second, performance-linked bonuses must be set aside in escrow accounts for a decade until it’s clear whether the true benefits of business strategies exceed their costs.

As long as there is no limit to how much money companies can put into politicians’ pockets, this fix will never be implemented. That’s because money puts big business in control of politicians who — if they were responding to the interests of the majority of Americans — would eliminate the conditions that make the benefits of business corruption exceed its costs.

But business corruption pays for those who finance Washington campaigns so the soil in which it flourishes remains fertile.

The same is likely to be true of unethical practices by and corruption of health care leadership. After all, health care leaders now mainly come from business management backgrounds, and so have been trained in the same way as financial professionals, and exposed to the same culture that they have experienced. As we have noted, the leadership of health care and finance often overlap. For example, see ours posts on the finance influence on the board of Dartmouth College; the role of the former CEO of bankrupt Lehman Brothers on the board of New York-Presbyterian hospital; the role of finance leaders who derided the Occupy Wall Street as "imbeciles," among other things on the boards of miscellaneous health care organizations; the role of finance leaders on the board of Pfizer, etc, etc, etc.

True health care reform may require larger reform in the greater society.  In any case, we need to reform the culture of health care organizations so that leaders put patients' and the public's health first, and self-interest last.  Furthermore, health care organizations should not provide positive incentives merely for exceeding financial or volume benchmarks, and should provide strong negative incentives for unethical behavior.

Manipulation of 12,000 Medical Records Made Easy by EHR

This from a hospital in Canberra, Australia using a common ED EHR in that part of the world, iSOFT:

Canberra Hospital embroiled in data scandal
SBI Magazine (Secure Business Intelligence)
Jul 5, 2012 

A Canberra Hospital executive has admitted to manipulating Emergency Department records to make wait times and stays appear shorter than they were.

The executive told the Director-General of the Health Directorate they had made "approximately 20 to 30 changes to hospital records" a day from "late 2010" onwards.

ABC [Australian Broadcasting Corp.] News reported that the matter has been referred to police, while the executive has been suspended without pay.

Though the data manipulation was initially said to be motivated by concerns over job security, changes in 2011 and early 2012 were said to have been made due to "managerial pressure" to improve publicly-reported performance statistics.

This raises the issue that data manipulation might have been performed not just to improve reported statistics, but to cover up medical error, computer related or not, and thus deny injured patients or their heirs the right to legal redress.

"The only thing that worked to achieve benchmark targets was to alter the data," the executive later told investigators at PricewaterhouseCoopers (PwC), which was engaged by Health to perform a forensics analysis. The analysis is detailed in a new Auditor-General report (pdf).

In total, PwC found 11,700 performance records - about six percent of all records stored in the hospital's iSOFT emergency department information solution (EDIS) - had been altered.

It is believed more staff at Canberra Hospital altered records than the executive that has so far admitted responsibility.  "While an executive has admitted to changing EDIS records, it is probable that EDIS records have also been manipulated by other persons with access to the system," the federal auditor-general noted overnight.

This is another area where electronic records make possible tasks that are probably impossible with paper.  Altering 11,000+ records would be hard in paper charts, as the alterations would likely stick out in a pronounced manner.

"The executive’s admission to Audit does not appear to account for all of the changes to EDIS records that have been made to improve timeliness performance."

For example, changes to EDIS records, albeit a much smaller number, appear to have been made on days when the executive was on leave (seven days in total in 2010-11 and early 2011-12). 

I am saddened to note, a proper term for this activity might indeed be "conspiracy":  a conspiracy is an agreement between two or more persons to break the law at some time in the future.

User access control, IT security failures

Poor controls such as generic logins and inadequate user and password security made it easy for insiders to game the data.

While EDIS was on approximately 259 workstations across the hospital and 253 users had permission to run the software, there were only 23 user accounts.

Of these user accounts, only eight were in regular use, including four named administrator accounts (specific to administrative staff) and four generic user accounts: CLERK, NURSE, DOCTOR and BEDMAN.

The generic accounts could be used by personnel across the hospital, not just within the Emergency Department.

Passwords for the four generic user accounts were "very poor" and had "never been changed". Password expiry was set at a default 999 days.

Audit logs were equally poor, not proactively checked and unreliable.

The proper term for these arrangements might be "gross mismanagement" of clinical information technology.

"A feature of the logging record is that it logs the changed field in EDIS and a number of other fields simultaneously, while not identifying which field was changed and what its original value was," auditors noted.

"Audit also notes that the logging record is also ineffective, because every entry in EDIS is logged from “Workstation 14”.  

"Although EDIS has been disseminated widely throughout the Canberra Hospital each of these users logs into EDIS using the common “Workstation 14”.

"This practice, combined with the use of generic user accounts, makes the EDIS logging information useless for investigations of unauthorised activity."

Furthermore, it was possible to edit EDIS records up to 72 hours after a patient’s treatment, providing a generous window for later unauthorised changes to the records.

These "features" sound like seller misdesign with regard to the metadata (logging records).

Noticing anomalies

It was only in April this year that a full inquiry was commissioned after "anomalies" in performance figures were spotted by the Australian Institute of Health and Welfare (AIHW).

The AIHW found an unusually high number of emergency patients that were reported to have been seen at exactly within the required time for their illness category.

For example, there was an unusually high number of patients who were reported to have been seen at exactly 30 minutes or 60 minutes.

In addition, an unusually high number of people checked out of the Emergency Department precisely 240 minutes after their recorded arrival.

If you're going to engage in this type of activity, at least be competent at it...instead of setting up a red flag bigger than the flag that used to fly over the Kremlin.

The records that were manipulated mean that publicly reported information relating to the timeliness of access to the Emergency Department and overall length of stay in the Emergency Department have been inaccurately reported.

The report could not ascertain the level of over‐estimation due to the lack of a clear audit trail identifying what were legitimate and what were fabricated entries in patients’ records.  

Timelines can be critical to proving medical negligence in court.  Further, if time data could have been manipulated, it seems clinical data could have been manipulated as well.

EHR data manipulation is of unknown magnitude worldwide, but I can imagine if it's easy to do and the benefits potentially substantial, electronic records could possibly be less trustworthy than paper records.

-- SS

Addendum:  while on the topic of clinical IT Down Under, there's also this:

Coast medical records system 'dangerous'
Stephanie Bedo
Goldcoast.com.au

July 6, 2012

SENIOR doctors say Gold Coast Heath's new multimillion dollar electronic medical record system is 'inadequate and dangerous' and could put patients' lives at risk.

Doctors have complained about the system, saying some patient documents are missing, it has log-in problems and 10-minute delays in accessing critical information.

Gold Coast Health was the first region in the state to move to electronic record-keeping, rolled out progressively from October last year.

Queensland Health spent about $200 million on the electronic medical record roll-out last year, which was delayed by 12 months because of problems with the software provider.

... Hospital cardiologist Dr Greg Aroney raised concerns about the system at a Griffith University forum on the future of health on the Gold Coast this week.

"Our system is totally inadequate and dangerous," Dr Aroney said.

Read the whole story at this link:   http://www.goldcoast.com.au/article/2012/07/06/429621_gold-coast-news.html

A similar story from the states where the doctors' complaints were actually ignored is at my Sept. 2011 post "Blake Medical Center (Bradenton, Fla.) Ignores Health IT Warning Letter From 100 Staff Physicians." 

Let's hope the Australian physicians' complaints are taken more seriously.

-- SS