Thursday, June 30, 2011

Hospital system has major computer breakdown with "resultant chaos"; patients not adversely affected (of course)

As mentioned on this blog numerous times. Healthcare IT outages never, but never, adversely affect patients in any manner whatsoever:

Traverse City Record-Eagle [Michigan - ed.]
June 30, 2011

Munson has 4-hour communications failure

By Bill O'Brien

TRAVERSE CITY — Munson Healthcare officials are trying to figure out how to avoid a repeat of a four-plus-hour data systems crash and "resultant chaos" that gripped local hospitals and clinics this week.
A system failure Tuesday morning shut down computers, telephones, pagers and other telecommunications systems at Munson Medical Center and its Munson Healthcare affiliates in Frankfort and Kalkaska, an incident that administrators described as "unacceptable." [That sounds about right - ed.]

Munson officials still aren't sure why a back-up fiber optic circuit failed during a planned outage that started Tuesday at 7:30 a.m.

"You can rest assured we're looking very carefully at that," Munson Medical Center CEO Kathleen McManus said. "Of course, we need to know what happened."
McManus said no patients were adversely affected during the outage. Even with the "resultant chaos" that gripped the local hospitals and clinics, no patients were adversely affected.

Amazing. There must be a cybernetic angel department in heaven that prevents patients from harm - i.e., from missed or delayed treatments or treatment mistakes - during the "resultant chaos" of major systems outages.

I'm sure insurers and risk managers have full confidence in Providence when these mishaps occur.

-- SS

July 1, 2011 update:

The Traverse City Record Eagle has published a memo explaining the outage:

Munson Healthcare officials distributed a memo on Wednesday that explained Tuesday’s systems failure that affected Munson Medical Center, Paul Oliver Memorial Hospital and Kalkaska Memorial Health Center and various clinics. The following memo is attributed to Chris Podges, Munson’s vice president of information systems.

“As you are all aware, we experienced an unplanned network downtime (Tuesday) that had widespread operational and clinical implications. Briefly, here is what happened:

Munson’s data centers’ connectivity to the outside world runs primarily on two redundant high speed fiber optic circuits administered by Traverse City Light and Power. We were informed by them that they needed to take one of the circuits off-line in order for them to do maintenance.

This would leave us operating on one circuit for the duration of their planned, 12-hour downtime. This shouldn’t have been any problem for us and is precisely why we have parallel, redundant technology on our most important systems and infrastructure. We have frequently tested for an event like this (losing one of the circuits) by manually “switching off” a fiber circuit.

In our testing, the remaining circuit took on all the traffic, just as it was architected to do; no hiccups, no instability, no impact on users, no downtime. And that is what we fully expected yesterday morning when one of the circuits was taken off line.

In medicine, or in any complex domain, one must expect the unexpected...

Unfortunately, that isn’t what happened. The core switch of the remaining circuit became confused, couldn’t take over the role as the primary switch (a transition which is measured in milliseconds) and ultimately shut down. Once down, everything running on the network – applications, paging systems, wireless devices, IP phones, etc., went down with it.

(I hear Kate Winslet humming in the background...)

Anthropomorphism aside, it seems to me that switches and other inanimate objects don't become "confused." The engineers/programmers who designed them just didn't anticipate the event that sinks the Titanic.

But let's roll the technology out nationally, now, rush...rush...rush...before it's too late. Computer bits get stale after awhile, after all....

Re: "Unplanned network downtimes." In the long running TV series Stargate SG-1 there's a character, Walter Harriman, who runs the command console. Just about the only line he gets to say over the base PA system over 10 seasons is ...


... when some person or alien attempts to come through from another Stargate somewhere in our galaxy or others nearby.

Perhaps hospitals can use him as a role model to announce "unscheduled down time"...

... During the downtime, we assembled a small army working on three objectives:

1. Make sure the hospitals and clinics could operate - especially as to the provision of patient care – on downtime procedures

2. Communicate as comprehensively and as often as we could

3. Fix the technical issues

Aside from the fact that these "objectives" are obvious, now hospitals need "small armies" to protect patients when a network switch gets "confused." Pen and paper offer no analogous bellicose hostilities.

While the reports are that all hospitals and clinics did a fantastic job surviving the down-time, we fully understand that it was very difficult to manage the resultant chaos and that downtimes like this are unacceptable.

But no patient was hurt (as they never are when the IT goes down).

Thursday morning at 2 a.m. we are going to re-introduce the second fiber optic circuit into our network architecture. While we expect no issues, we’re planning otherwise. This afternoon your organizations will receive specific instructions on how to prepare for the event of another network outage; What to print in advance of 2 a.m., what resources are available to you during the downtime, how to get needed clinical information without the use of computers, who to call for help, etc.

Thank god.

Again, we do not expect any downtime tomorrow morning, but we did re-learn some valuable lessons yesterday and the safety of our patients is the number one objective should the network experience another issue. We’ll be ready at 2 a.m. and we want your organizations to be ready, too.

Why do such "lessons" need to be "re-learned" - EVER?

We are working diligently to understand what happened yesterday and will share with you what we learn and our plans to remedy whatever may need attention.

In effect, they really don't understand what caused the outage.

This is similar to other cases of outages written about at Healthcare Renewal. There's never certainty, because these IT systems have become so complex and the support relatively diffused (via outsourcing, consultants, etc.)

This is a fertile ground for patient injury and death when luck runs out. As stories like "Failures in care alleged after premature birth - $1,000,000 Settlement" from the Virginia Lawyer's Weekly I referenced here imply, the cost of ownership of HIT will likely go way up once the multimillion dollar lawsuits start adding up.

Considering the track record of health IT as it is in 2011 regarding reliability, risk/benefit and security, spending hundreds of billions of dollars to put patients at risk of life and limb, and risk of potentially career-ending or bankrupting loss of privacy, en masse nationally, is increasingly brainsick.

-- SS

Electronic medication prescribing: The Magic Bullet Theory of IT-Enabled Transformation once again bites the dust in the real world of medicine

Computers once again are proving not to be the plug-and-play-panacea they've been made out to be in the complex world of medicine. The Magic Bullet Theory of IT-Enabled Transformation once again bites the dust in the real world of medicine:

Errors Occur in 12% of Electronic Drug Prescriptions Matching Handwritten
By Michelle Fay Cortez
Jun 29, 2011

As many as 12 percent of the drug prescriptions sent electronically to pharmacies contain errors, a rate that matches handwritten orders for medicine from physicians, researchers said.

An analysis of 3,850 computer-generated prescriptions written over a four-week period found 452 contained errors, including 163 that could harm the patient, according to a report published today in the Journal of the American Medical Informatics Association. The rate was consistent with past studies reviewing the risk of errors when a doctor writes a prescription and hands it to the patient, the researchers said.

Pens and prescription pads are orders of magnitude less expensive than multimillion dollar computer systems, I might add.

The results undermine the expected safety benefits from computer-generated prescriptions, said the study authors led by Karen Nanji of Massachusetts General Hospital’s anesthesia, critical care and pain department. The U.S. paid more than $158.3 million to doctors and hospitals in the first half of 2011 to encourage adoption of electronic health records, which President Barack Obama has advocated as a way to lower health- care costs and reduce medical errors.

"Expected benefits?" Expected under what assumptions? [The assumptions that computers are a 'magic bullet' of some sort for complex real-world problems, and that technological determinism applies, are my best guesses as to the major ones - ed.]

“Providers appear to be rapidly adopting electronic health records and computerized prescribing, and one of the major anticipated benefits is expected to be through medication-error reduction,” the researchers wrote. “Many of these benefits will not be realized if the electronic prescribing applications are not mature and either do not catch or even cause new medication errors.”

If health IT are indeed medical devices (as per CDRH Director Shuren, see this link) but they are "not mature", then why are they on the market without pre-marketing validation, post-marketing surveillance and other regulatory requirements faced by other medical devices?

“With more than 3 billon prescriptions written annually in the U.S. alone, this could amount to 385 million errors each year, with 128 million of them having the potential to cause patient harm, said researcher Jeffrey Rothschild, from the center for patient safety research and practice at Brigham and Women’s Hospital in Boston.

If the technology is this unreliable at this time, then perhaps investing hundreds of billions of dollars in it in 2011 is premature?

Feeling a bit like Harry Markopolos once again, I offer what I am going to call Healthcare Renewal's Rule #1 of Cybernetic Common Sense in Medicine:

"Computers can only solve problems amenable to be being solved by computers, and only when all steps in their design and implementation are led by bona fide, domain-experienced, competent problem solvers."

This will not happen in the Wild-West health IT ecosystem that currently exists.

USB-equipped Magic Bullets. Click to enlarge.

I have been asked what is needed for this industry to mature.

Conceptually, the first step is: regulatory consistency.

As previously mentioned, Jeff Shuren MD JD of FDA's Center for Device & Radiological Health (CDRH), a physician and a lawyer, called health IT a "medical device". On Feb. 25 2010 he stated:

... Under the Federal, Food, Drug, and Cosmetic Act, [that regulates all drug, medical devices, etc. in the United States -ed.] HIT software is a medical device.

Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems).

Treating "HIT software" as such - as a medical device - with all that implies, would be a first step. Instead - for whatever political reasons - HIT is given special accommodation.

We could do the reverse to achieve regulatory consistency as well. What about de-regulating other medical devices and drugs? Might that not work out well?

One might also ask, if that's a ridiculous option, then why does HIT, even more potentially dangerous than a drug, stent or defibrillator get a pass?

Why is HIT even more potentially dangerous
than a drug, stent or defibrillator?

There's a critical, infrequently addressed issue that arises as IT capabilities advance.

HIT is much more than a medical device like a stent or defibrillator, since it increasingly acts as a "coach" in the sports meaning of the term, or a "conductor" of clinicians in the sense of, say, a Herbert von Karajan or Eugene Ormandy as conductor of musicians.

The computer increasingly calls the shots, so it in effect is increasingly a cybernetic intermediary or "proxy" between doctor and patient. (In essence, the "learned intermediary" metaphor is obsolete; for instance when a doctor fired up some expert system, posed a question about what antibiotic to best use, and then either used or ignored the outputs. The computer is now between doctor and patient.)

Here are tragic, if accurate, allegations of a computer in control of clinicians: the child death lawsuit complaint #2 at my post "Babies' deaths spotlight safety risks linked to computerized systems" at :

Count 42: Defendants told Plaintiffs that the incorrect date on the image caused the x-ray not to be read by a radiologist in the night the image was taken, and that if the image had been correctly dated February 27, 2010, it would have been reviewed by a radiologist immediately, who would have alerted Defendants that the PICC line was improperly positioned and had to be moved back to a safe position. However, since the film was incorrectly dated February 23, 2010, the film was classified as “old” [BY THE COMPUTER PROGRAM - ed.] and was not put in line for immediate review [BY THE COMPUTER PROGRAM - ed.], and was not reviewed in time to prevent injury to Plaintiffs Decedent.

Count 45: Defendants told Plaintiff that the x-ray from the 27th, which was mislabeled as being from the 23rd, would have been reviewed by the neonatologist on duty on the morning of the 28th, but this did not happen because the computer which places films in line to be reviewed would have ignored such an “old” film. [That is, the computer cybernetically made the decision that the radiologists need not read the film, and in doing so exerted deadly interference with the clinicians' work - ed.]

If a machine is to be given this kind of authority, i.e., as a conductor or governor of clinicians, its competence to do so needs to be extensively and robustly validated.

A neurosurgeon doesn't cut into someone's head before their skills in that regard have been extensively validated.

Why do cybernetic intermediaries get special regulatory accommodation, especially when evidence is increasingly mounting that, as of 2011, they are often deficient?

-- SS

Tuesday, June 28, 2011

More Revelations About How Top Managers Prosper While Care-Giving Employees are Laid Off This Time Leads to Labor Strife

Last month, we discussed the contrast between executive compensation at Salinas Valley Memorial Healthcare System (SVMH), a small California public hospital system, and the treatment of employees in the trenches. While the hospital had laid off workers ostensibly because of the poor economic climate, the local newspaper revealed that its CEO was leaving with a multi-million dollar retirement package, and that some of his supposed severance pay had been given him before he was severed.

This month, amidst growing labor unrest partially driven by the disparate treatment of the hired top manager and the more lowly employees who actually take care of patients, a new report revealed further contrasts between how hired executives and "regular" employees are treated.

Let me give a blow by blow summary in chronological order.

The Employees Strike

This month, the hospital system suffered its first strike ever, partially in response to the discrepancy between executive compensation and how lesser employees were treated.  According to the Los Angeles Times:
About 850 workers at a Salinas public hospital went on strike Tuesday, about two months after revelations of a multimillion-dollar pension awarded to the hospital's CEO.

Caregivers at Salinas Valley Memorial Hospital walked off their jobs at 6 a.m., according to representatives of the National Union of Healthcare Workers. The workers are protesting proposed layoffs and cuts to their retirement benefits as well as pay given to hospital executives and consultants.

The Times reported in April on the retirement package granted the hospital's outgoing chief executive, Samuel Downing, which included about $5 million in supplemental payments along with a $150,000 annual benefit. Hospital officials and board members have defended the package, saying that Downing was a successful leader throughout his 27 years as CEO.

The hospital workers' union has been negotiating with administrators since January and indicated its plan to strike earlier this month, according to union vice president John Borsos.

'There's a sense of disbelief here that the hospital can come up with millions of dollars for Downing's retirement and millions for their consultants, but when it comes to caregivers by the bedside, they say they can't find the money,' he said.

The Management's Lock-Out

Then, hospital managers' responses to the strike provoked more anger from union members, and one state agency affirmed their complaints, according to The Californian:
The California Public Employment Relations Board issued a five-page complaint against Salinas Valley Memorial Healthcare Systems, alleging that the public hospital district violated several sections of state labor law when it barred striking workers from returning to their posts Wednesday.

Prompted by charges brought by the National Union of Healthcare Workers, PERB Regional Attorney Katharine Nyman charged SVMH with committing unfair labor practices and with violating PERB regulations in the way it blocked workers from going back to work after Tuesday's one-day labor walk-out.
Strikers Picket a Board Member

Then, the union escalated its protest by picketing the house of the hospital board treasurer, according to television station KION:
Thursday morning, some union members took their demonstration from the front entrance of SVMH directly to the home of Harry Wardwell, Treasurer of the SVMH Board of Directors and President of Rabobank. 129 employees were still unable to go back on the job, replaced by temporary workers for one more day.

Wardwell is one of five publicly elected members of Salinas Valley Memorial Healthcare System's Board of Directors.

'We have to draw the Salinas community and everybody in the hospital district. Every resident in this neighborhood votes and they need to know that Harry Wardwell is making these cuts,' said Marilyn Benson, an NUHW member.

How Executive Pay Rose Faster than Inflation While Employees Were Laid Off

Just after that protest ended, The California published a new article about executive compensation:
At the same time it laid off hundreds of rank and file employees, the Salinas Valley Memorial Healthcare System steadily provided generous increases to the salary and benefits packages of its senior executive team, records show.

SVMH vice presidents Bev Ranzenberger, John Fletcher, Dr. David Perrott, Elizabeth Lorenzi, Irene Neumeister and James Griffith all received double-digit increases in their total compensation packages during the years of 2005 through 2010 according to an SVMH document obtained by The Californian on Thursday.

And while not all of the vice presidents received salary increases every year during that time period, they all received percentageincreases in total salary and benefits of 29.4 percent to 153.8 percent, which translates to annual average increases of between 5.9 percent and 30.8 percent. By comparison, for the12 months that ended in May, the national rate of inflation rose just 3.6 percent, based on the Consumer Price Index.

News of the increases incensed National Union of Healthcare Workers leaders whose members went on a one-day strike Tuesday after declaring an impasse with health care district management over wage and benefit issues and over how many more employees will be laid off as SVMH continues to struggle with reducing costs.

'How could a majority of the board approve of the outrageous salary increases while claiming that the hospital had to lay off hundreds of caregivers out of financial necessity?' asked union vice president John Borsos. 'It's not just hypocritical, but it demonstrates that the hospital has more than enough money to keep caregivers at the bedside.'

Note that the SVMH leadership's defense of the pay given top executives was typical of explanations of outsize pay given to other health care leaders:
But according to SVMH spokeswoman Adrienne Laurent, the executives' salaries are in keeping with industry standards and have been reviewed by an outside consulting agency for appropriateness.

"Compensation for our hospital executives is not taken lightly, and that's why our [Board of Directors] engaged an outside, third party to assist us in this process. An important goal set forth by our board is that all of our employees, including our executives, receive compensation that is comparable to our competitors. In order for us to successfully recruit and retain the best people, it is critical that we remain competitive with not only other public district hospitals, but also private companies," Laurent wrote in an email to The Californian.

In her email, however, Laurent did not address the seeming disparity of the institution increasing executive salaries while at the same laying-off employees.

Laurent also added that the six SVMH vice presidents do not enjoy some of the standard perquisites offered to executives at other health care institutions such as bonuses and car and cellphone allowances.
It must be tough having to pay for a cell-phone package when one's salary is only somewhat in excess of a quarter-million dollars a year.

Note that the irony of defending high pay to recruit "the best people" to executive positions while health care professionals are being laid off seemed to escape Ms Laurent.

Once again we see how the notion that "top management are different from you and me" plays out throughout the health care system. Even at a small public community hospital system, the top hired managers seem to feel entitled to be treated differently, and much better than other employees, even those who directly care for patients.  Top hired managers do not flinch at the doublethink necessary to use poor financial results as a rationale for laying-off line employees, but simultaneously for hiking the pay of top hired managers.

Again, we see how top hired managers of all sorts of health care organizations, big and small, for-profit, not-for-profit and government, delivering direct care, and manufacturing products used in care, have become accountable only to themselves. This situation, of course, produces health care done first for the benefit of its new overlords.

The case of Salinas Valley Memorial Healthcare, however, also now demonstrates that this situation is starting to produce reactions.  It now seems that the ordinary employees of health care organizations are not continuing to welcome their new overlords. SVMH endured its first strike ever mainly in response to the disparity between how top hired managers treated other employees and treated themselves. Angry employees publicly identified the board of trustees that seemed to exert no functional oversight over top management as part of the problem. I suspect that if current trends continue, we will see more labor unrest, and that unrest will be directed at hired managers and those who are supposed to oversee them.

This may eventually yield major changes in how health care is lead, but if the confrontations continue, these changes may be very messy, and continued strife may end up being bad for everyone.

Instead, we should consider real, peaceful health care reform. As I have repeated endlessly,... 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.

Monday, June 27, 2011

CEO Compensation: Nothing to See Here, Just Move Along

An article in the Washington Post showed how uncomfortable executives of big corporations, including health corporations, are about making their outsize compensation transparent. 
Here’s one financial figure some big U.S. companies would rather keep secret: how much more their chief executive makes than the typical worker.

Now a group backed by 81 major companies — including McDonald’s, Lowe’s, General Dynamics, American Airlines, IBM and General Mills — is lobbying against new rules that would force disclosure of that comparison.

The lobbying effort began more than a year ago. It involved some of the biggest names in corporate America and meetings with members of both parties on the House Financial Services Committee and Senate banking committee.

The companies and their Republican allies in Congress call comparisons between the chief and everyone else in the company 'useless.'

It's not just useless, they also claimed:
Disclosing such comparisons 'can mislead or confuse investors,' said Rep. Nan A.S. Hayworth (R-N.Y.), who filed the bill to repeal the disclosure. 'It creates heat but sheds no light.'

She also said the calculation of the ratio would be a burden for companies, especially those with global operations.

One apparent reason for their discomfort is that the pay of top hired executives has been skyrocketing while the pay of most other employees stagnates:
'The real reason House Republicans want to keep the typical worker’s pay secret is that it may embarrass some companies to reveal that they pay their CEO in the range of 400 times what they pay their typical worker,' said Sen. Robert Menendez (D-N.J.), who added the requirement to the financial regulatory overhaul bill that passed last year.

Executive compensation at the nation’s largest firms has more than quadrupled in real terms since the 1970s, according to research by Carola Frydman of MIT’s Sloan School of Management and Raven E. Molloy of the Federal Reserve, even as pay for 90 percent of American earners has stalled.

In 1970, average executive pay at the nation’s top companies was 28 times the average worker income, according to the Frydman-Molloy data and numbers provided by Emmanuel Saez at the University of California at Berkeley. By 2005, executive pay had jumped to 158 times that of the average worker.

Behind the repeal effort are some of the largest US companies:
The Center on Executive Compensation has led the criticism of the provision. The group is part of the HR Policy Association, which represents the human resources executives at 325 large companies.

The thrust of the group’s criticism is that the information would have little value for investors comparing firms, because companies have workforces that differ in skills and expected pay. Wages also vary across regions and industries.

Current rules already require disclosure of executive compensation; the new requirement calls for the additional disclosure of median worker pay. Critics say that would add little to what is already known.

'You can already tell where a CEO falls relative to his peers,' said Tim Bartl, senior vice president and general counsel for the Center on Executive Compensation. 'You can already tell where he falls relative to the average worker in the industry. What is this number going to tell us?'

Last year, the HR Policy Association paid Bartl’s law firm, McGuiness & Yager, more than $1.5 million for lobbying, according to

The HR Policy Association's board of directors includes executives from some of the biggest health care corporations, including pharmaceutical and device firms (Amgen, Johnson and Johnson, and Merck), commercial health insurance companies and managed care organizations (Aetna, CIGNA, and Humana), and other firms with major health care interests (General Electric, Procter and Gamble).

Note that Mr Bartl's concession that calculation of the ratio would be simple seemed to contradict Rep Hayworth's claim that the calculation would be burdensome.


It certainly appears that top hired managers of big corporations are not happy about the common people seeing how huge their pay is compared to that of other workers. They seem particularly unhappy to have their own stockholders, the common people who actually own their companies and to whom they theoretically report see how much they are making. Perhaps they fear the realization that they may be running their companies more for their personal advantage than in the interests of their supposed owners, much less the other, lesser employees, much less their customers, clients and patients, much less the public at large.

The ability of small cabals of top executives at big corporations to set their own pay independent of the wishes and interests of the corporations' owners would seem to be the fundamental threat to the capitalistic and free market ideal. After all, in my humble and perhaps naive opinion, private ownership is central to capitalism, and the apparent managers' coup d'etat seems to be a existential challenge to private ownership. (For much more informed commentary on how executives have wrested control from owners, see the blog Naked Capitalism and Robert A G Monks' website.) One wonders why so few of the many vocal supposed supporters of capitalism and free markets fail to see this as a problem.

Even though it is increasingly informative to see what has happened to health care within the context of the larger political economy, Health Care Renewal, however, is about health care issues first. So to put this in health care terms....

First, we see again how top leaders of health care organizations prefer opacity to transparency, especially when that opacity increases their ability to put self-enrichment ahead of their organizations' missions and ultimately individuals' and the public's health. They embrace opacity when it protects the perverse incentives that likely are the major cause of increasing health care costs, declining access, and worsening quality.

To repeat, and repeat, and repeat.... to reform health care, we must reverse the managers' coup d'etat, and restore leadership of health care organizations that puts the mission, and the health of patients and the population first, and is accountable to corporate owners (when applicable) and to patients and the public.  But that will mean now going up against those who have made themselves the richest and most powerful people in the country and the world, who will not lightly give up their oligarchy.

Google is shutting down its cloud-based Google Health, a Personal Health Record service

Google is shutting down its cloud-based Google Health, a Personal Health Record service, by the end of the year.

I wrote:

"Who'da thunk it? -- Personal Health Record project with big corporate sponsors not working out so well ..."

"Label me skeptical: Personal Health Records as healthcare panacea?"

both in 2007.

Considering the education and expertise one needs to really manage (and comprehend) health records robustly, let me state that I consider the entire concept of the "personal heath record" inane.

You heard it here first.

-- SS

Babies' deaths spotlight safety risks linked to computerized systems

A new tragic case. (A second, earlier case of infant death was posted in March 2011 here).

See Baby's death spotlights safety risks linked to computerized systems by Judith Graham and Cynthia Dizikes in the Chicago Tribune.

A baby died at Advocate Lutheran General Hospital due to an intravenous solution containing a massive overdose of sodium chloride — more than 60 times the amount ordered by the physician. The authors write:

Although a series of other errors contributed to the tragedy, its origin — a piece of data entered inaccurately into a computer program — throws a spotlight on safety risks associated with medicine's advance into the information age, a trend being pushed aggressively under health reform.

One wonders if any type of alert was generated, and if not, why not.

What are hospitals getting for their tens to hundreds of millions of dollars they are throwing at clinical IT?

Technology can be a great blessing in medicine. I am alive and healthy in 2011 thanks to it. The medical condition referred to in the aforementioned letter was in fact cured as a result of advances in cardiac electrophysiology science, as here and here, pgs. 1 and 2).

However, technology cannot be applied cavalierly, lawlessly (per attorney Sharona Hoffman), experimentally, without regulation, and without informed patient consent as is often done in the world of HIT.

-- SS

Also see another case at my aforementioned March 2011 post "Thanks to the wonders of EHR, this premature baby went to the grave, prematurely" at this link, from an Oct. 2010 story in Virginia Lawyers Weekly ("Failures in care alleged after premature birth - $1,000,000 Settlement"). A PICC line was also involved.

-- SS

Friday, June 24, 2011

Embedded Networks of Influence in Health Care: An Illustrative Case

At the 12th International Anti-Corruption Conference (IACC), sponsored by Transparency International, one of the plenary sessions was devoted to the topic of "embedded networks of influence."  The session description included this description of the topic as:
the major stumbling block in the fight against corruption, namely, the power of 'embedded networks' in advancing personal or group interests through state institutions. The extent of their power can create what is known as “state capture” meaning democratic governance failure. It will take a close look at the influential role of private sector, especially of the multinational private sector.
A recent investigative report in the Chronicle of Higher Education illustrated a striking case of how one key individual has affected health care through multiple connections to what can be regarded as embedded networks of influence, thus tying in to many of the topics we have discussed on Health Care Renewal.

The article focused on the University of Miami and its current President, Donna Shalala. Let me summarize the set of relevant topics in roughly chronological order and note how the article links them to President Shalala.

Speech Codes and Restrictions on Free Speech within Academia

As I wrote in my 2003 article, (Poses RM. A cautionary tale: the dysfunction of the American health care system.  Eur J Int Med 2003; 14: 123-130.  Link here), speech codes and other restrictions on free speech within academia created the framework for the suppression of clinical research that may offend those with vested interests:
Failure of universities to champion the academic freedom of their clinical researchers may stem from their abandonment of their own academic core value of free enquiry. There is abundant evidence that universities may restrict expression and limit academic freedom. In The Shadow University, Kors and Silverglate charged that 'universities have become the enemy of a free society.' Universities have punished faculty and students who raised unpopular viewpoints.

In the Chronicle,
Ms. Shalala, ... was previously president of Hunter College of the City University of New York and chancellor of the University of Wisconsin at Madison....

The Shadow University, the pioneering work on challenges to individual rights by leaders at academic institutions, dealt with Ms Shalala's role as a leading early proponent of silencing speech that offended academic leaders.
Wisconsin chose to enact a speech code. On March 29, 1990, the Wisconsin ACLU joined a suit against the university, announcing that the important moral goals of toleration and equal opportunity 'can be accomplished through means other than the creation of rules which infringe upon the fundamental freedom to express ideas.'

The speech code was drafted with the help of UW-Madison Law School professors Richard Delgado, Gordon Baldwin, and Ted Finman.... On June 9, 1989, upon recommendation by Chancellor Shalala, it was adopted by the Board of Regents...."
The speech code was soon declared unconstitutional by a federal court, which held:
the policy was unconstitutional precisely because 'the UW rule regulates its speech upon its content.'
Ms Shalala then:
recommended a new code to the regents in the spring of 1992, which they adopted in March.
Faced with another lawsuit, the regents reversed themselves
For these and similar efforts, as discussed by Evans and Novak in 1993, Ms Shalala was dubbed "the Queen of PC" [political correctness].

Speech codes and other restrictions on free speech in the academic setting seem mainly to be used to target speech that administrators find offensive, including speech critical of management practices. This is echoed in the Chronicle story, which suggested how fearful University of Miami faculty now are of criticizing Ms Shalala:
Others, including several current and former faculty members, outline their complaints in far more detail. But they do so anonymously, saying they don't want to tangle head-on with such a politically powerful president.
Ms Shalala's prominence in academics, probably more due to rather that in spite of her hostility to free speech and free enquiry, may have enabled her to join another and even more powerful network of influence, this one at the center of the US political world.
The Rise of Commercial Health Insurance 

In Deadly Spin, former CIGNA executive Wendell Potter documented how clever and unscrupulous use of public relations and marketing techniques enabled commercial health care insurance and managed care companies to increase dominance of US health care, while allowing health care costs to soar, and denying access to larger numbers of patients. 

The Chronicle article briefly alluded to Ms Shalala's role in the rise of for-profit health insurance.  Despite being labelled "farthest to the left and most controversial of all President-elect Clinton's Cabinet appointments," again per Evans and Novak, Ms Shalala departed the University of Wisconsin in 1993 to become US Secretary of Health and Human Services. In that role, she presided over the administration's failed attempt at health care reform, as Potter wrote,
When President Bill Clinton was forced to give up on comprehensive health care reform in 1994, the damage was far more extensive than anyone could have imagined - the administration's defeat emboldened health insurance companies to totally redefine the mission and methods of an industry that now strands nearly fifty million people without insurance.

As I outlined..., insurers knew after the Clinton disaster that the coast was clear for them to abandon nonprofit practices, long-standing commitments to public service, and traditional insurance models and turn instead to satisfying Wall Street investors' desire to make money, by limiting spending on health care.
Note that my only quibble with what Wendell Potter wrote is that it may be that the insurance companies' top executives, rather than their stockholders who benefited the most from these changes, as we will address below.

Ms Shalala remained Secretary of HHS until 2001, but after the failure of the health care reform proposal in 1994, her department apparently did nothing to try to ameliorate the changes to health care that Potter described above.

Bloated Executive Compensation Disproportionate to Any Measure of Organizational Performance

We have frequently discussed how health care leaders now seem entitled to get huge amounts of compensation disproportionate to their organizations' performance and their responsibility for it. 

Despite Ms Shalala's reputation in the 1990s as an extreme leftist, upon leaving her role in the Clinton administration, she almost immediately embraced the for-profit corporate model of health insurance. In a notable example of what now is called the "revolving door" that went unnoticed at the time,  Ms Shalala went from would be regulator of commercial managed care to leader of commercial managed care.  As noted by the Chronicle:
Debates over ethical boundaries are not new to those involved in the university's growth surge. Ms. Shalala was on the compensation committee of the board of the health insurer UnitedHealth Group when it was caught in one of the nation's largest-ever stock-options scandals. She also received low-cost loans in 2002 as part of a favors-for-politicians scandal at Countrywide Financial Corporation.

Both Ms. Shalala and [University of Miami medical school dean] Dr. Goldschmidt have served on the boards of companies directly or indirectly affected by the university's business decisions. The university had $30-million in annual business with UnitedHealth Group when Ms. Shalala was on its board.
Note that Ms Shalala served as Secretary of Health and Human Services from 1993 to 2001, (see this list), then joined the board of UnitedHealth Group within months (see this article.)

We discussed in considerable detail the ethical failings of UnitedHealth Group while Ms Shalala had fiduciary responsibility as a board member for its conduct. A particularly striking failing was how the board of directors granted sufficient back-dated stock options to the company's former CEO to make him a billionaire on paper.  The resulting scandal was followed by his resignation.  Later, Dr McGuire was forced to give back some the options.  The final settlement of the fiasco cost UnitedHealth $895 million, and Dr McGuire $30 million and the cancellation of 3.6 million stock options.  As we most recently summarized here, former CEO William McGuire was one of the top 10 best compensated CEOs of the first decade of the 21st century, despite the company's multiple ethical failings. 

Conflicts of Interest, Especially Involving Key Opinion Leaders who Promote Marketing Objectives Cloaked in Academic Respectability

We have extensively discussed the web of conflicts of interest that now pervades health care. For academic health care leaders, the most intense kind of conflict of interest may be created by service on the board of directors of a for-profit health care corporation.  Note that corporate directors, as we have discussed previously, have a fiduciary duty to exhibit "unyielding loyalty" to the stockholders of the company and their interests  [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.].  We first started to discuss the intense conflicts of interest generated when leaders of academic medicine are also members of boards of directors of for-profit health care corporations in 2006.  The issue really made the big time in 2010 when the New York Times published a front page article in its Sunday Business section about whether university presidents who also were corporate directors were part of an "academic-industrial complex."  As we noted above, Ms Shalala's service on the board of UnitedHealth Group created such a conflict, and she apparently presided a similar board level conflict of interest affecting her medical school dean. 

A particularly pernicious kind of conflict of interest may be created when a company selling health care goods or services pays an academic to become a "key opinion leader."  Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There are documented instances (e.g., see posts here and here) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post here).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

The Chronicle recounted how Ms Shalala also was linked to one of the better known examples of industry paid KOLs:
Dr. Goldschmidt did not fully report the income from such corporate associations on the medical school's financial-disclosure Web site, even while promoting the site as evidence of his faculty's commitment to openness. He also brought to Miami a repeat violator of financial-conflict-of-interest standards, Charles B. Nemeroff, to serve as a professor and chairman of the department of psychiatry and behavioral sciences.
In a companion article, the Chronicle summarized Dr Nemeroff's career thus:
Dr. Nemeroff had quit as chairman of Emory University's psychiatry department in December 2008 after the university received complaints about his secretly receiving money from GlaxoSmithKline and other pharmaceutical companies while helping promote their products.
We (Dr Bernard Carroll more than yours truly)  have posted previously about Dr Nemeroff's exploits, including those at the University of Miami, numerous times

The Fall of Municipal Hospitals, the Rise of For-Profit Hospitals

We have frequently discussed how the leaders have undermined health care organizations' core missions, and particularly how hospitals and hospital systems have strayed from their patient care mission to make more money. The Chronicle suggested how Ms Shalala's leadership of the University of Miami has enriched the institution's teaching hospital at the apparent expense of the local municipal hospital system:
Another set of problems, cited by current and former university faculty and Jackson staff members, stems from the 2007 takeover of a facility that became the University of Miami Hospital, across the street from Jackson. The purchase has greatly expanded the university's ability to direct many of the area's most profitable patients and procedures to the new facility and to other university-owned hospitals, further worsening Jackson's own considerable budget woes.
In addition,
The university's patient-enrollment practices were part of the problem. The inspector general of the U.S. Department of Health and Human Services and the U.S. Attorney's Office for the Southern District of Florida are looking into the question of whether university doctors routinely enrolled Jackson patients in research projects without telling the hospital.

In a 2008 letter from Jackson officials to university leaders, Nathan Anspach, who was vice president for physician services at the hospital, described a series of failed efforts 'to stop new clandestine research' at Jackson by university doctors.

Meetings with university officials aimed at stopping the practice 'went badly,' Mr. Anspach wrote, and Dr. Goldschmidt, the medical-school dean, was 'outwardly annoyed' by Jackson's requests for information that would help it identify research patients in the building.

Ms. Shalala was copied on at least some of the correspondence, including a 2006 letter in which Marvin O'Quinn, then-president and chief executive of the Jackson Health System, which runs Jackson Memorial, warned Dr. Goldschmidt about the legal risks of submitting claims for patient care that should be covered by a medical study.

The current director of compliance at Jackson Health System, Diana Salinas, said the allegations are a matter of investigation by the two federal agencies. Ms. Shalala and Dr. Goldschmidt told The Chronicle that they were unfamiliar with the matter. 'This must not be a very big issue,' Ms. Shalala said, 'because none of the Jackson senior leadership has ever brought it up with me.'
And the departing chief executive of the Jackson Health System, Eneida O. Roldan, whose appointment two years ago was supported by the university, said medical-school officials made clear from the start 'that they were going to take cardiology across the street.'

Ms. Dixon-Shim, of the support-workers' union, is among those who say they've seen it happen. 'Most of the indigent patients, they're staying at Jackson,' she says. 'But most of the private patients, the physicians are taking them over to their area' at the university-owned hospitals.
Note that we previously discussed how Jackson's financial troubles lead to a bid by for-profit Steward Health Care to take it over.


So, through her mutiple roles that allowed her to serve at several key nodes of networks of influence in health care, one person has been linked to multiple dysfunctional aspects of US health care that arguably have been responsible for our increasing costs, declining access, and poor quality.  Note that these multiple roles seem to have been logically and even ideologically inconsistent, suggesting that multiplying her roles within the  networks may have been more compelling to her than logical or ideological rationales for particular actions.

We have discussed before, the leadership of health care organizations has become incredibly interrelated, interlocked, and incestuous. It appears that top leaders of various health care organizations may be more familiar with and identify more with each other, and with other hired executives and managers, than with their organizations, their organizations' missions, and their organizations' professionals, staff, students, clients, and patients.  It now appears reasonable to characterize the relationships among health care leaders as embedded networks of influence. 

So to repeat- I strongly believe that there needs to be much more investigation, academic, journalistic, and perhaps legal, of the identity, nature, and culture of the leaders of health care, and their relationships. A few bloggers cannot do it all. Obviously, the anechoic effect mitigates against medical and health care academics looking into their own leaders. However, failing to understand who is leading our march to the brink of health care failure ought not to be something such academics would want on their conscience.

Finally, and obviously, 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.

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.

Monday, June 20, 2011

The Managers' Coup: How the "Hired Hands" Got "Paychecks as Big as Tajikistan"

We have frequently discussed the perverse incentives provided to the leaders of health care organizations.  They almost never pay a penalty for presiding over organizational actions that are unethical, harmful to patients, or even criminal (e.g., see posts here and here for some very recent examples.)  However, they often collect outrageously huge compensation disproportionate to any reasonable measure of their organizations' performance.  (e.g., see posts here and here for relevant recent examples.)

Now two news articles, based in turn on research studies, further illuminate how hired managers and executives have become so wealthy and unaccountable.

The first news article was in the New York Times, and was in turn based on an accounting study.  In summary,
a recent, immensely detailed report in The Analyst’s Accounting Observer, a publication of R. G. Associates, an independent research firm in Baltimore. Jack Ciesielski, the firm’s president, and his colleague Melissa Herboldsheimer have examined proxy statements and financial filings for the companies in the Standard & Poor’s 500-stock index. In a report titled 'S.& P. 500 Executive Pay: Bigger Than ...Whatever You Think It Is,' they compare senior executives’ pay with other corporate costs and measures.

Here are some of the major comparisons the report makes:

- Paid More than the GDP of Tajikistan
Total executive pay increased by 13.9 percent in 2010 among the 483 companies where data was available for the analysis. The total pay for those companies’ 2,591 named executives, before taxes, was $14.3 billion.

That’s some pile of pay, right? But Mr. Ciesielski puts it into perspective by noting that the total is almost equal to the gross domestic product of Tajikistan, which has a population of more than 7 million.

Again, note that all comparisons below refer only to these 2591 most highly paid executives of 483 companies, not all the companies' executives.

- Paid More than Audit Expenses
158 companies paid more in cash compensation to their top guys and gals last year than they paid in audit fees to their accounting firms.

- Paid More than Income Taxes
Thirty-two companies paid their top executives more in 2010 than they paid in cash income taxes.

- Pay Rises While Stock Prices Fall
The report calculated that at 179 companies in the study, the average value of stockholders’ stakes fell between 2008 and 2010 while the top executives at those companies received raises.

- Paid a Substantial Fraction of Total Operating Revenue
It identified 24 companies where cash compensation last year amounted to 2 percent or more of the company’s net income from continuing operations.

The article used a health care example to illustrate this one:
Topping this list is Allergan Inc., the health care concern whose top executives received, after taxes, an estimated $2.6 million in salaries last year. That amounted to 50 percent of what the company earned from continuing operations, the report said.

Further details made this a particularly telling example of perverse incentives given to executives:
Caroline Van Hove, an Allergan spokeswoman, said that the salaries were large when compared with net income in 2010 because one-time charges reduced earnings significantly that year; in previous years, she noted, earnings were far higher than executives’ pay. She also said the company’s C.E.O. had not received an increase in salary over the past three years.

Parenthetically, some of the charges that affected Allergan's earnings were clearly due to a $375 million fine after a guilty plea to a federal misbranding charge and $225 million related civil penalties the company paid in 2010. As we noted in this post, the US Department of Justice alleged that Allergan paid kickbacks to promote a drug for unapproved uses. Thus, what cost the company a major piece of its revenues were costs related to unethical behavior including one federal misdemeanor, and allegedly paying kickbacks to doctors to promote a drug for unapproved uses. However, while this behavior caused a marked drop in earnings, the research above showed the impunity of the executives who presided over this behavior, whose compensation held steady or rose.

- Paid a Substantial Proportion of Research and Development Expenses
Moving on to R.& D. costs, the report examined the 62 technology companies in its sampling that reported such an expense, excluding certain costs associated with acquisitions.

Mr. Ciesielski found that the median level of executive pay was equal to 5.3 percent of these companies’ R.& D. expenditures.

- Pay Equal to a Substantial Proportion of Market Capitalization
Finally, there’s the comparison of executive pay with market capitalization. As Mr. Ciesielski noted, this calculation provides the biggest shock value.

Eleven companies analyzed in the report gave top executives a combined pay package amounting to 1 percent or more of the companies’ average market value over the course of the year.

To put it a different way, for a few corporations, the pay of the top five executives was equal to at least one percent of the total value of the corporations as measured by the value of all stock shares outstanding.

In summary, the R. G. Associates' report suggests that the salaried executives, who the NY Times article reminded us are "hired hands," were generally paid amounts that seemed outrageously disproportionate to every metric used.

Furthermore, a second article in the Washington Post provided an even more astonishing comparison.

- Paid Enough to Become a Majority of the Richest Americans
The largest single chunk of the highest-income earners, it turns out, are executives and other managers in firms, according to a landmark analysis of tax returns by economists Jon Bakija, Adam Cole and Bradley T. Heim. These are not just executives from Wall Street, either, but from companies in even relatively mundane fields such as the milk business.

The top 0.1 percent of earners make about $1.7 million or more, including capital gains. Of those, 41 percent were executives, managers and supervisors at non-financial companies, according to the analysis, with nearly half of them deriving most of their income from their ownership in privately-held firms. An additional 18 percent were managers at financial firms or financial professionals at any sort of firm. In all, nearly 60 percent fell into one of those two categories.

So now it appears that the disproportionate compensation given to hired executives of large corporations, including health care corporations, have made them the majority of the very rich.  Most of the very rich are thus hired corporate employees, not company owners, not entrepreneurs, not even those who inherited wealth, or who are sports stars or rock musicians. This transformation of the face of the very wealthy has occurred at a time when the other employees of those corporations have generally stagnant incomes, and when those who have invested in those corporations, including many in the middle-class who have invested their retirement savings, have barely made money.

So it turns out that in large corporations, including large health care corporations, it has become all about the top bosses.  The top bosses are likely to be paid enough to make them some of the richest US citizens.  Their pay likely comes off the top, so it has priority over profits and stock-holders gains, much less the pay of the lesser employees. 

So it is clear that hired executives of large corporations have engineered perverse incentives for themselves that means never having to say they're sorry, never having to be accountable for anything the company does wrong.  Hence, there should be no mystery why US health care is the most expensive in the world, and despite its expense, is not very accessible and not of good quality.  The main culprit is a peculiar perversion of laissez faire capitalism in which the top managers have staged a coup, and have become the new oligarchs and plutocrats, and thus put their interests ahead of all others. 

So to reform health care, we must reverse the managers' coup d'etat, and restore leadership of health care organizations that puts the mission, and the health of patients and the population first, and is accountable to corporate owners (when applicable) and to patients and the public.  But that will mean now going up against those who have made themselves the richest and most powerful people in the country and the world, who will not lightly give up their oligarchy.

EMRUpdate's thoughts on health IT

I had posted about my relative's travails at the site where I have written or cross-posted a number of essays over the years. The site's proprietor Nick Harrington of the U.K. replied. In his bio:

Managing Director of UK based document management software vendor Ambay Software providing hosting and support to

I recognized a number of familiar themes in his reply.

In turn, I replied to his reply as follows:

Nick Harrington replied on Mon, Jun 20 2011 10:12 AM

Dr. Silverstein,

We're sorry for your loss. Genuinely.

However, I don't think this is the right place for you to start a campaign against EMR. The Healthcare industry is making big progress in the quality of patient care directly as a result of using Information Technology. The single act of providing computerized Electronic Health Record for a patient - whatever shape or form from many vendors - makes available important medical information to the whole team involved in patient care. It allows information to be readily available, to be carried with the patient as they move within the health system, it allows Doctors to be more aware of previous treatments, drug regimes and how best to care for this patient now in this consultation or emergency.

Unfortunately laying blame at the door of IT and Electronic Medical Records isn't at all reaslistic and is unlikely to win your anything more than genuine sympathy. Certinaly no support for your premise that EHR is a direct cause of death, however unfortunate its circumstances.

I do wish you peace and strength in your sad bereavement.


My reply:

Nick Harrington wrote:

Dr. Silverstein,

We're sorry for your loss. Genuinely.

However, I don't think this is the right place for you to start a campaign against EMR.

Thanks for the expression of sympathy. It is appreciated.

A few clarifications though:

I have never maintained a "campaign" against EMR. I merely hold views that experimentation on patients with problematic, poorly engineered, unregulated medical devices (that are deliberately given special accommodation with regard to the federal FD&C act per Jeff Shuren at CDRH, see FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs), and without informed consent, is unethical. As per Hoffman & Podgurski at Case Western School of Law, what I am against is the lawlessness of the industry today.

Nick Harrington wrote:

the Healthcare industry is making big progress in the quality of patient care directly as a result of using Information Technology

Much current and emerging literature refutes that (such as the sampling at this link). In consideration of this literature, today's commercial health IT is not yet ready for large scale rollout from an ethical perspective. Doing so is experimentation by definition. Doing s, especially without patient awareness or consent, is in violation of decades of policy on human experimentation (e.g., see HHS "Human Research Protections Frequent Questions.")

These are first principles, not open to debate. Even modest NIH research grant proposals involving health IT undergo strict review for human subjects (and researcher) protections. I know first hand, as a sat on a Study Section on health of the population and provided Medical Informatics expertise to such proposals.

Nick Harrington wrote:

"The single act of providing computerized Electronic Health Record for a patient - whatever shape or form from many vendors - makes available important medical information to the whole team involved in patient care. It allows information to be readily available, to be carried with the patient as they move within the health system, it allows Doctors to be more aware of previous treatments, drug regimes and how best to care for this patient now in this consultation or emergency."

Ideally, yes. However, we're still quite far from the ideal. At present, what we have is an unknown level of "health IT roadkill" on the way to perfecting the technology. As predicted by the field of Social Informatics, there are also other unanticipated and likely adverse side effects (such as at link), outcome unknown.

Nick Harrington wrote:

Unfortunately laying blame at the door of IT and Electronic Medical Records isn't at all reaslistic

That depends in what setting, and to whom, the blame is laid.

In any case, regarding my relative: may she rest in peace, and may my efforts [i.e., at whistleblowing on health IT problems] result in others not having to suffer similar mistakes at the hands of IT.

Nick Harrington wrote:

I do wish you peace and strength in your sad bereavement.


Thanking you kindly.

-- SS

Sunday, June 19, 2011

A Biomedical Informatics Manifesto

Note: this essay was originally posted in Oct. 2008. In view of my relatives's injuries due to interference of EHR's in clinical processes, I think it worthy of reposting.

A Biomedical Informatics Manifesto

"We need to recognize that in our society's efforts to improve healthcare, we are attempting to create virtual clinical tools for complex and unforgiving medical settings that happen to involve computers, and that facilitate healthcare, not information systems that happen to involve doctors and clinicians that (in line with the bellicose grandiosity characteristic of IT marketing) will "revolutionize" healthcare. - S. Silverstein (me - ed.)

The American Medical Informatics Association is moving towards having the field of Biomedical Informatics formally declared a medical subspecialty with the help of a $300,000 grant from the Robert Wood Johnson Foundation. While this is good, it is a long time in coming.

I have been thinking a great deal about the recent Joint Commission Sentinel Events Alert on the potential dangers of poorly conceived and implemented healthcare IT. I wrote on this issue at the post "Joint Commission Sentinel Events Alert On Healthcare IT".

Noteworthy is the fact that the research of current Biomedical Informatics specialists and allies figure heavily in the Alert’s references.

I can only wonder what motivated the Joint Commission to issue such a potentially industry-adverse advisory (adverse to common and profitable health IT industry practices that create these issues, that is) at this time. President-elect Obama, after all, has made HIT a significant part of his agenda.

Perhaps as cases of HIT difficulty and patient harm become more commonly known, the Commission does not wish to appear to have been caught unaware as have other regulatory agencies in the face of recent turmoil in the housing and financial sectors. I have heard rumors from my readers, in fact, of major stories about HIT malfunction that might in fact reach a wide public audience in the coming years. Considering the turmoil in the housing, economic and investment sectors, perhaps the Joint Commission does not want to be seen in the same light as a Fannie Mae or an SEC.

In any case, the alert's appearance raises a meta-issue:

Why was such an alert even necessary?

None of the issues the alert raises, ranging from safety risks, unintended and preventable adverse events that these implementations can create or perpetuate via fundamental errors of either commission or omission, ill conceived human-machine interfaces and organization/system design, etc. would be very commonplace if the teachings of 40+ years of Biomedical Informatics research was heeded.

Some of those researchers could probably have written the Joint Commission alert on HIT in the 1960's. In fact, they largely did.

Biomedical informatics research goes back to the pioneers such as the writings in 1968-9 of Dr. Donald Lindberg, (now director of the U.S. National Library of Medicine at NIH and a key figure in funding for Bioemedical Informatics postdoctoral training), the "Ten Commandments" of Octo Barnett regarding HIT in 1970, the five major reasons for lack of HIS success by Morris Collen in 1972, the four reasons for lack of HIT diffusion by Friedman and Gustafson in 1977, and many others [1].

Why has it taken forty years for this research to be reinvented and regurgitated by a major healthcare regulatory agency? How many billions of dollars have been wastefully spent, and how many patients have been adversely affected by bad informatics, in all those years?

Biomedical informatics research currently includes the work of the formal departments and centers in the field such as these funded by the NIH in the U.S. and others funded by their own universities, departments of Biomedical Informatics in other countries, sociologists (e.g., Ross Koppel, Jos Aarts to name just a few), social informatics experts, the iSchool consortium, and many others working in a cross-disciplinary manner.

In my own case, I have been writing on these issues since my eye-opening experiences as a Chief Medical Informatics Officer (CMIO) in the mid-1990's at Delaware's largest healthcare organization. I am astonished that the issues I wrote of then are current today; I often hear the exact same stories from current CMIO's over a decade later.

I can say that none of the Joint Commission warnings were necessary on my watch as CMIO; I was cognizant of all these problems as a result of several years of studying the issues in the time I spent in the deep cave known as the Yale Cushing/Whitney Medical Library during my Biomedical Informatics fellowship and faculty time, as well as by direct observation using the simple skills of a medical internist but applied to IT.

My writings have been widely viewed (see my 2006 AMIA poster "Access Patterns to a Website on HIT Failure", ppt file at this link). Yet, as a Google or other search engine search on "healthcare IT failure", "healthcare IT difficulty" or similar concepts demonstrates, explicit information on this topic remains curiously limited. On the contrary, a search on "medical malpractice" brings up literally millions of "hits."

Why do the healthcare IT dangers that are the subject of the JC alert occur at all? A clue can be found in the following observations.

The problem can be summed up like this:

Biomedical Informatics as a specialty might as well be invisible. Amateurs rule HIT.

(Note: I use the term "amateur" not in a pejorative sense, but in the sense that I am a radio amateur or “ham” with formal licensure after governmental examinations and significant technical and applied telecommunications experience. I am not a telecommunications professional, however, who should be, say, leading a critical telecommunications initiative for a hospital or large business.)

Here is my most recent and indeed most personal evidence Biomedical Informatics is still largely invisible. My former chair of medicine from my residency, a consummate clinician trained at Yale and now Chief of Staff of an 800+ bed hospital complex, opined regarding an opening for a Director of Clinical IT at his organization (in reference to my application, which was summarily ignored by the IT department other than the typical form letter reply) that "I do not believe it is a Sine qua non that a physician be at the helm of the clinical informatics enterprise". He knew of my career path since my residency in the mid 1980's.

Now, this same person wrote a letter of recommendation in 1992 to Yale's Center for Medical Informatics about my qualifications for a Biomedical Informatics postdoctoral fellowship at his alma mater. The letter indeed mentioned the evening in 1986 when I went "way outside the box" as a resident at his hospital and used my IT expertise to repair a CT scanner's computer that was malfunctioning and that had been abandoned for the evening by the vendor.

My repair brought the CT scanner online, and changed the intervention on a mid 20's unknown male brought to the ED with profound mental status changes from a potentially catastrophic lumbar puncture to the appropriate neurosurgical intervention - to manage a huge hydocephalus caused by a benign obstruction within his brain. The patient survived.

The statement directed towards me that "a physician is not a Sine qua non of a healthcare informatics initiative" thus clearly identifies me as "a physician", not a "formally trained and experienced biomedical informatics professional who is also a physician." (One would hopefully never hear that "a surgeon is not a Sine qua non of major abdominal surgery.")

That the field of biomedical informatics could have been so invisible to such a person suggests to me the field is simply a Black Hole to others even less well informed about its practitioners:

The environment around an invisible Black Hole. Is this how the
healthcare industry sees the field of Biomedical Informatics?

Other occupations (I've personally seen IT personnel, MBA's, business consultants, "process re-engineers", 'techie' docs and nurses with just enough IT knowledge to be dangerous, social workers, and a cadre of others) are thus free to commit what I term "cross-occupational piracy" upon HIT. They do not do a stellar job of it.

Thus, the Joint Commission alert becomes necessary.

This phenomenon was also apparent in pharma. I note the following essay at the excellent blog "In the Pipeline" by medicinal chemist Derek Lowe, PhD, in a Dec. 19, 2008 post entitled "My Compound Goes Where the Wild Goose Goes" that:

A colleague and I got to talking yesterday about something that I'm sure many chemists have noticed. Have you ever chased down some reaction or compound in the literature, only to find yourself wild-goosing back to some obscure journal that no one has ever read - just because no one can be bothered to publish a modern procedure?

Here's how that typically works. You run a SciFinder search on Molecular Structure X. A list with a dozen references comes up. There's a Tet. Lett. from 2002, but what are the chances it'll have any spectral data (or anything useful at all?) Ah, there's one from Tetrahedron in 1995, that should do. So you look over the PDF, search for your compound. . .there it is, number 17. Now to the experimental. . .and you find in the first paragraph that "Compound 17 was prepared according to a published procedure", footnote thirty-eight. And the footnote is to. . .ay, it's to a Chem. Ber. paper from 1932. Ausgezeichnet!

Oh-kay. Back to that SciFinder reference list. How about that Tet. Lett. paper? Nope, on inspection, it turns out to reference the 1995 paper you just looked at. What else? There's a JOC from 1984, let's try that. Good ol' JOC, solid stuff. Well, digging up that PDF, you find that it refers to a 1980 paper from the same group from Synthesis. Hrm. So you chase that one down, there it is, compound 9, and the experimental for it is. . . footnoted to the 1932 paper. Again.

What he is referring to is the "wild goose chase" that often plagues medicinal and other chemists in performing syntheses, essential to the drug discovery process. He is pointing out the use of the cheminformatics resource known as "SciFinder" by the American Chemical Society. An ACS division provides the largest databases of publicly disclosed chemistry-related information and makes the information accessible through search and retrieval software such as SciFinder, along with links to the original literature and patents.

SciFinder is an essential tool to the modern research chemist. Some pharmas (e.g., Pfizer) made this tool widely available to its scientists. Which makes my experience in Big Pharma astonishing, in that I as a science library director in a company with a declining pipeline of new drugs had to fight a long battle with a non medical, non science-background IT VP over ending rationing of said tool, among others, to save a few million $ per annum. I was dumbfounded. This in a drug giant boasting $60 billion in market clout and 60,000 employees.

In the end, my department received only a fraction of what I asked for, and that was soon taken away (not from me personally, but from the scientists, ultimately) as budgets declined. My appeals to senior management as a Biomedical Informatics professional, a.k.a. information scientist, might as well have been invisible as well.

I was ultimately laid off by the VP for my efforts, leaving laggards who had tolerated this mind-boggling, truly absurd situation that impaired drug discovery behind.

Black hole OJ287, mass of 18 billion Suns.

Unfortunately, I doubt FDA will issue a similar alert about the dangers of research IT leadership by non scientists.

In effect, the Joint Commission Sentinel Alert affords an opportunity for a return to some sanity in healthcare IT endeavors.

It is my view that the Biomedical Informatics community and its allies need to leverage this perhaps first-ever acknowledgment from an organization with clout that HIT is not a harmless panacea and needs to be subject to informed discipline and rigor (as medicine itself). They need to leverage it to end the "black hole of invisibility", irrespective of the bureaucratic and prolonged process of having the field declared a medical subspecialty, the outcome of which is uncertain.

The alert needs to be leveraged each and every time a Biomedical Informatics professional finds themselves being marginalized. It needs to be leveraged as a hammer. "Political correctness" (aptly abbreviated "PC", pun intended) on these matters ultimately gets patients killed. You know you're afflicted with the terminal PC bug when you feel reluctance to tell your CIO and IT personnel who lack training, knowledge and experience in clinical medicine, and who've just concluded contracts for the world's worst clinical IT without sufficient end user involvement, that they, in fact ... lack training, knowledge and experience in clinical medicine.

When told that the CIO or IT people or the COO or the CFO or the MBA process re-engineers "know better" than informatics experts what clinicians should be doing and what they need to care for patients; that informatics experts don't have enough project management or other mundane experience; that they are too academic; that doctors don't do things with computers; that a biomedical informatics expert is not the "Sine qua non" of a major healthcare informatics initiative; that the vendor whose products impaired a national HIT initiative overseas has assured us their products are just dandy, and so forth ...

... the reply should itself be a well-justified bit of bellicosity.

Biomedical informatics professionals should stand up, speak out, and make it count:

"What part of 40+ years of Biomedical Informatics research and experience don't you understand?"

-- SS


[1] A History of Medical Informatics in the United States 1950-1990 (pp. 167-175), Morris F. Collen B.E.E., M.D., 1995, American Medical Informatics Association, ISBN 0-9647743-0-5.