The Rise of the Corporate Physician - the End of the (Health Care) World As We Know It?

In discussing how concentration and abuse of power threatens health care professionals' values and professionalism, we have discussed how ostensibly academic institutions value faculty more for their earning power than their academic abilities.  We have discussed how financial relationships between physicians and drug, biotechnology, device and other companies risk abuse of entrusted power.  But up to now, I have been comforted by the hope that physicians in small independent practices who do not have such conflicts of interest are trying to uphold their professional values, even as they were buffeted by the perverse incentives imposed by managed care organizations/ health insurance companies and government insurance (e.g., US Medicare whose payments are controlled by the RUC).

However, a recent article in SmartMoney suggests that the end of the independent physician is nigh:

Remember the solo family doctor? In places like Springfield, it has become increasingly likely that she's collecting a paycheck from a large regional hospital—and practicing medicine according to the hospital's strict playbook. The experience in Springfield is just a needle prick compared with what's going on nationwide. At least one in six doctors—more than 150,000 nationwide—now works as an employee of a hospital system. And with about half of recent medical school graduates deciding to work for hospitals and many established doctors looking to unload their practices amid the tough economic climate, what was a trickle of change has turned into a torrent. Jim Pizzo, a Chicago-area hospital consultant, says the blistering pace of these mergers is leading some colleagues to joke that there are two types of physicians today: 'Those employed by hospitals and those about to be.'

So we are seeing physicians who practiced solo or in physician-lead, physician-run group practices becoming employees of large health care organizations. And here on Health Care Renewal, we know how most large health care organizations are run.

This appears to be an unintended consequence of our recent US health care "reform" law:

But hospital executives also believe that buying doctors' practices could yield a big payday, thanks to a different provision in the health care law. The law will encourage doctors and hospitals to share some payments when treating each patient; as collaborative teams, they could earn bonuses for holding down costs and meeting quality markers. 'The real question for everyone is how that pie—that money—is going to get split up,' Goertz says; hospitals think they'll have the upper hand if they employ the doctors that they're sharing their banana crème with. And that's touched off a flurry of mergers everywhere—from Seattle to Roanoke, Va.

The name of these supposedly collaborative organizations, which are turning out to simply be hospital systems which have purchased physicians' practices and now employ physicians, is "accountable care organizations," which now appears ironic at least.

The article detailed some of the adverse effects to be expected when accountable care organizations become hospital systems with employed physicians providing patient care.

Increased Costs with Decreased Care

Ruth Taylor, a 44-year-old woman in Bozeman, Mont., started seeing Robert Hathaway as her doctor during college, and she stuck with him through everything from routine blood tests to a kidney transplant. Taylor, a professional nurse with warm blue eyes, describes Hathaway as a 'classic small-town doctor' who knew all his patients by name and socialized with them at local basketball games; he was accessible and thorough—even catching a health problem of hers that other doctors had missed. But after Hathaway sold his practice to the local hospital, Taylor says, things began to sour. She was more likely to be assigned to see the physician assistant rather than Hathaway himself. And when she went in for a comprehensive physical (also run by the assistant) in late 2008, she was charged $360, more than double what she'd paid for a workup in previous years.

Imposition of Dysfunctional Health Care Information Technology

On this blog, Dr Scot Silverstein frequently posts about how poorly designed and implemented commercial health care information technology may have harms that outweigh any benefits, and how these systems are rarely objectively evaluated. Employed physicians are likely to be required by their new executive overlords to use commercial health care IT that benefits the managers and their strategies, but may not benefit patient care:

Last spring Hospital Sisters tried to shift all of its Springfield medical offices to electronic medical records simultaneously. But there wasn't enough tech support to deal with all the problems physicians ran into on day one, and wait times spiked at the system's walk-in locations. Nenaber, a soft-spoken 64-year-old with wire-rim glasses, sounds acquiescent about the situation. 'We're getting the hang of these things,' he says slowly, sitting at his desk overlooking a gas station and a strip-mall parking lot. But his practice is still waiting for its electronic payoff

Increasing Prices by Providing Care in the Hospital

Now that the acquisition spree is in full swing, some experts worry that price increases could become the dominant narrative for patients. When hospitals run medical practices, federal law allows them to add substantial 'facility fees' to patients' bills to cover overhead expenses. The new bosses also often rip equipment like X-ray machines and MRIs out of the physician's office, preferring to have patients get those tests from radiologists at the hospital. That, too, can cost patients. A consumer with a high-deductible Aetna plan, for instance, would pay up to $1,400 for an MRI of her back at the University Medical Center at Princeton, N.J., according to data that the insurer makes available to its members. The same scan would cost about a third as much at nearby Radiology Affiliates of New Jersey, a nonhospital facility. Based on a review of insurance databases and state regulatory records, that's a fairly typical price gap

Increasing Prices by Market Domination

Price increases also have the potential to bleed outward—affecting not only the patients of the absorbed doctor, but also the cost of health care citywide. That's because when hospitals sit down at the bargaining table with insurers, they're almost always able to negotiate higher payment rates for their big groups of doctors than a lone physician with little bargaining power

Despite the usual spin provided by the would-be monopolists:

Fast-growing hospital systems, including Hospital Sisters and Bozeman Deaconess, say that their growth will eventually make care more efficient and bring costs back down, since they'll be able to cut back on unnecessary care and duplicate tests

I am sure that the 19th century robber barons made the same pitch about increasing efficiency. Of course, the efficiency mainly benefits the insider managers.

By the way, of course, the hospital systems own public relations machines and lobbyists are now busy attacking any restrictions on such concentrations of power, while the hospital managers figure out how to game the system to increase their market domination before the regulators notice:

As more patients face such disruptions, regulators are taking notice. In October, the Federal Trade Commission and the Department of Health and Human Services met with doctors, insurers and other health officials to discuss the referral and pricing problems that could arise from 'accountable-care organizations'— those new groups of hospitals and doctors that will share financial incentives. The Federal Trade Commission will offer guidelines on what's permissible by midyear. But hospitals are already lobbying for accountable-care groups to be exempt from antitrust and antifraud rules, even as they scoop up more and more medical practices. Under current regulations, officials in Washington must green-light all mergers involving companies valued at more than $63 million. But by buying up tiny medical practices one at a time, critics say, hospitals stay below the threshold and avoid getting much attention. And by the time regulators settle on more-formal legal guidelines, those mergers may be hard to undo, says Cory Capps, a Washington economist specializing in health care antitrust issues.

Excess and Unnecessary Utilization via "Leakage Control"

With big hospital systems now owning physician practices, and practicing physicians directly answering to executives, the push will be on to maximize use of the most lucrative services. Once the hospital systems have made employees out of the physicians, it is easy to pressure their own employed physicians to refer patients to the hospital units that can bill most lucratively:

By their own admission, most hospitals are eager to keep patient referrals under the same corporate umbrella, to save on costs and share medical records but also to boost revenue. The hospitals say they wouldn't force an internist, for example, to refer a patient with heart problems to their own cardiologists, but critics say there's certainly financial pressure. Under a little-noticed regulation that took effect in 2007, hospitals are allowed to pay doctors less if they don't do enough internal referrals.

Doctors in Bozeman and Springfield who granted interviews said they didn't feel pressure to be 'team players' with referrals. But some of those who've left large health systems tell a different story, including Mark Callenberger, an orthopedist in Merritt Island, Fla. Callenberger says that the hospital group where he used to work urged him to direct more patients to the MRI machine owned by the hospital. The doctor preferred a more advanced machine at a private practice that he says offered clearer pictures. But after he ignored the recommendations, Callenberger says, the hospital told his office manager to schedule patients at the hospital's MRI anyway, leaving him to perform surgery using 'crummy images.' (The hospital declined to comment on Callenberger's case but says its doctors can use whatever facilities they choose.) Patients may never know about these power struggles, because doctors aren't required to disclose how they choose specialists. And while patients who ask can always see a specialist outside the network, in practice few are likely to challenge their doctors' judgment, says Bruce A. Johnson, a Denver health care lawyer. 'Face it, when we're really sick,' says Johnson, 'if the doctor tells us to jump off a roof, we'll probably consider doing it.'

Note that we discussed (here and here) the example of a for-profit hospital system with a large number of physician employees pushed to choke off "leakage" of patient referrals outside the system.

Summary

The overarching problem is that employed physicians now must answer to managers and executives who may put financial goals, and their own enrichment, ahead of physicians' values, and specifically will choose increased revenue over providing the best possible care to individual patients:

. Executives here are also hoping to push the needle further—standardizing everything from how long patients wait on hold to the ease of parking at the doctor's office (valets, luxury-restaurant style, are one solution under consideration).

Still, Mikell acknowledges, 'doctors don't want follow-the-directions, cookbook medicine.' And for many physicians, the idea of following new rules triggers a much larger unease at giving up their independence—a feeling of loss, both for the businesses they built and for their patients. Back in Bozeman, Blair Erb, the sole cardiologist in town, is a picture of resignation as he prepares to sign a contract with Deaconess. 'I feel defeated,' Erb says, looking around at the office furniture he and his wife, Liz, chose from a catalog years ago. The weathered ranchers and bundled-up women that come through his door mostly express disbelief when they hear that this frank-talking Tennessee native will sell his practice. His staffers say they're not looking forward to the questions the hospital's medical records system will soon prompt them to ask patients. (Do you wear a bike helmet regularly? Do you have a smoke detector?) 'We'll try to retain as much professional independence as possible,' Erb says, gazing at the hospital building, whose bulk he can see through his window. 'But the fact of the matter is, we'll have a new master.'

So I for one do not welcome our new executive overlords.

We have posted about numerous examples of health care organizational leaders who put their own enrichment ahead of the mission. Now even ostensibly non-profit hospital systems are increasingly competing against for-profit systems. We have seen, as noted above, an example of a for-profit system that seems to betting everything on a business strategy to reduce "leakage" of patient referrals.  We can expect that non-profit hospital systems will have to act more like for-profit systems, and the perverse financial incentives given the managers of all hospital systems will lead to pressure on physicians to forgo their responsibilities to provide the best care to individual patients in favor of actions that will bring in the most money in the shortest time.

We seem to be witnessing the rise of the corporate physician, the rise of a physician who must first answer to managers who never committed to putting patient care first, who may have no sympathy for physicians' core values, who may receive huge incentives to maximize short-term revenue no matter what. Such a rise of corporate physicians would be unprecedented in the US, and I believe in any developed country.

The rise of the corporate physician would require patients to put their trust in corporations, rather than individual doctors, in the era of the global financial collapse, in the new gilded age.

We may be seeing the end of health care world as we know it. The upcoming brave new world of health care may be worse that we can imagine.

What is to be done? - I rarely have ventured into specific policy suggestions, but I think that the consequences of the well-intended "accountable care organization" blunder may be so severe that I must so venture now. We must derail the movement towards "accountable care organizations." Any movement to make organizations more accountable cannot do so by making most professionals into employees answering to the sorts of ill-informed, incompetent, self-interested, conflicted or even corrupt leaders that we have been writing about for more than six years on Health Care Renewal.  We need to make it impossible for for-profit companies to employ physicians to take care of patients.  Maybe we need to think about making it impossible for for-profit companies to provide patient care at all, and for for-profit companies to sell health insurance.  Meanwhile, we need to ensure the accountability, integrity, transparency, and honesty of leaders of health care organizations.

If we do not reverse the current trends, anyone who wants good health care may have to look for it somewhere other than in the US.

On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts.

Note: the reports to which this post refers are available as a set of PDF's from the University of Sydney, NSW, Australia at this link (12 Mb, .zip folder).

March 6, 2011 addendum. Also see my new post "What to do about the state of the ED EHR in NSW?"

Over ten years ago now, 1999 in fact, I started my healthcare IT difficulties website.

That site, "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" now resides on a Drexel University server in Philadelphia, Pennsylvania USA at this link, and used as a teaching resource.

I started the site after observing, for lack of a better description, "crazy stuff" in the commercial healthcare information technology sector.

Crazy stuff such as EMR systems for ICU's that crashed regularly and spread pathogens around, EMR's for invasive cardiology cath labs that were an informational jumble and abyss and that also issued regular General Protection Faults and died, lack of Medical Informatics expertise (and actual disdain for it) in healthcare IT projects, grossly incompetent IT leaders, and hospitals uncritically and enthusiastically buying these products as if they were a plug and play, proven technology.

To make matters worse, I also observed executives expressing a hostile indifference to glaring deficiencies.

My observations about health IT and about responses to my counsel brought to mind the biblical passage:

"Give not that which is holy unto the dogs, neither cast ye your pearls before swine, lest they trample them under their feet, and turn again and rend you." - Matthew 7:6

I was never afforded the opportunity to perform a forensic analysis of the internals of these systems, being that I was not allowed to obtain the software or "schematics" of the data structures. In fact, to make the cardiology system usable, I ordered the IT staff to simply discard the internal data dictionary, relational data structures, input screens, and analytic routines, and rebuild them - from scratch - using a proper Medical Informatics-based, cardiology domain expert-driven, iterative and incremental (agile) approach.

The result was a resounding success, and was described in a written report as "exceptional" by national specialty association reviewers invited to evaluate the effort.

(A success for which, I might add, I and my enlightened executive sponsor were paradoxically demonized by the IT department and hospital executives; cf. Matthew 7:6.)

Now, an Australian researcher of considerable computer and database expertise, Professor Jon Patrick at the University of Sydney, has put considerable ink to a forensic evaluation of the internals and external reactions to an EMR system "built in America", Cerner Firstnet.

Professor Patrick holds a Ph.D. from Monash University. He came to the University of Sydney from Massey University, New Zealand, where he held the foundation Chair of Information Systems. Professor Patrick won Australia's national Eureka science prize in 2005 for developing a natural language processing system that detected financial scams in web pages at the behest of the Australian Government.

FirstNet is an ED EHR that government officials decided must be installed in ED's of public hospitals throughout the Australian state of New South Wales. Promo material below, click to enlarge:

FirstNet promo material, page 1. Click to enlarge. (Hmm ... Is there a subliminal message in the picture of the doctor and nurse?)

FirstNet Promo material, page 2. Click to enlarge.

The initiative's been underway for several years, and the result is a group of apparently very unhappy Wal-Mart shoppers. (I guess the correct line would be "unhappy Big W shoppers" for those Down Under.)

Prof. Patrick had written a preliminary essay on the issue entitled, in rhetorical question-style, "The Story of the Deployment of an ED Clinical Information System: Systemic Failure or Bad Luck?" back in 2009. He apparently found himself in considerable hot water for doing so due to 'pushback' as I described at "Academic Freedom and ED EHR's Down Under: An Update". However, his university stood by him in defense of academic freedom (and of the sanctity of those in the healing arts, I might add).

He's spent the intervening time expanding the analysis of the ED clinical system and its deployment considerably, right down to the fine nuances of relational database design in complex domains (such as biomedicine).

As I wrote in an initial post "A Study of an Enterprise Health information System - Finally, an Informatics Scientist Does A Rigorous Review of a Commercial EHR System, by Cerner", the TOC of his new analysis are these (the files are available as a .zip archive at this link):

3.0 Part 0 - Executive Summary
3.1 Part 1 - A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck? First published here in Oct 2009, revised Dec 2009.
3.2 Part 2 - Discussions with ED Directors: Are we on the right track?
3.3 Part 3 - Discussions with Software Performance Experts.
3.4 Part 4 - Conceptual Data Modelling.
3.5 Part 5 - Database Relational Schema and Data Tables.
3.6 Part 6 - Coalescing the Analyses of the ER Diagrams, Relational Schemata and Data Tables.
3.7 Part 7 - The Integrated Assessment.
3.8 Part 8 - Future HIT Regulation Proposals.
3.9 Part 9 - Ockham's Razor of Design. Published at the IHI conference, Nov 2010 Washington.

I have been reading these sections, and have found the technical sections (parts 4-6) highly informative about a major suspicion I've held for many years.

I suspected chaos in the health care IT software engineering process, with inadequate attention to quality, rigor, fine detail, resilience engineering, talent management and other practices essential in development of mission critical products of any type.

Prof. Patrick's forensic analysis, while not proof of my concerns, certainly supports them. If Boeing produced aircraft with malfunctioning engines, broken seats, defective flaps, tires that blew on landing, and rust right out of the factory (like the Chevy Vega of old?), one might suspect the development and manufacturing environment could be substantially problematic.

The theme of apparent violations of fundamental precepts of relational database design run consistently through his analysis of the FirstNet product.

Without getting too technical (which I can, having written successful relational database-based clinical information systems of considerable complexity for challenging environments, with novel user interaction design besides), I see evidence of developmental chaos.

Examples: primary key-foreign key inconsistencies and problematic usages ("keys" are flags used to link sets of information about some object or entity, such as a patient to their diagnoses or meds), internal field nomenclature faux pas (there are best practices on how to do this to enhance software quality and maintenance), cryptic documentation , "stale bits" (old code and data) from past iterations remaining to create "glitches", unreliabilities and new problems, and other technical sins apparently abound.

These can be read about in sections 4-6 of Prof. Patrick's analysis. The issues can be summarized as he did in the part 6 Abstract:

Consistent weaknesses in sections of the Millenium clinical information System (CIS) are revealed in the combined study of the ERD (entity-relationship diagram), logical schema and the data tables. PK (primary key, i.e., unique identifier) values are not always defined unambiguously at the design level and data tables reveal inconsistencies in declarations and data validation. There is evidence that keys are managed by software within the application rather than by the in-built functions available in the database management system leading to less confidence in data integrity.

He goes on to relate:

The [technical design] weaknesses in terms of clinical work practices, that have been identified are only likely to show up in occasional circumstances with a combination of processing and data values separated in time. [In other words, the resulting errors are unpredictable, and depend on variable factors about the patient's data and user's attempted actions that cannot be predicted ahead of time - ed.] Staff are not likely to associate one instance of missing or mis-processed data with another. This spasmodic nature tends to lull staff into a false sense of security that the mis-processing is either inconsequential or an accident of their own making. We recommend that each and every mis-processing experience be recorded as accurately as possible so that appropriate computational forensic analysis can correctly identify if weaknesses in the underlying technology have been the source.

These are dead-serious matters, literally. One's well being in an ED should not depend on random chance. If you are the "lucky patient" who Wins the Lottery or Hits the Jackpot on health IT mis-processing, or whose clinicians are distracted by user experience flaws, "workarounds", demoralization or other issues, you might end up maimed - or in the grave.

The ED EHR Slot Machine. Click to enlarge. You've hit the ED EHR mis-processing jackpot! Perhaps today is a good day to die...

I do not believe mission critical software for, say, avionics, or for implantable medical devices, suffers such sloppiness. (In part due to regulation, which health IT lacks entirely in the U.S.).

The UK, having their own HIT issues (see my Aug. 2010 "Battle of Britain" post at this link), apparently learned something, as evidenced in:

Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software. UK National Health Service, DSCN18 (2009), formerly ISO/TR 29322:2008(E).

and

Health Informatics — Application of clinical risk management to the manufacture of health software. UK National Health Service, DSCN14 (2009), formerly ISO/TS 29321:2008(E).

That said, I will now comment in more detail on a part of the analysis readily understandable by 'database laypeople': part 2, "Discussions with ED Directors: Are we on the right track?" (again, probably a rhetorical question).

In this section, candid discussions were held with the Directors of seven Emergency Departments in New South Wales public hospitals assessing the impact of the introduction of the FirstNet information system into their ED's. The effort has been ongoing for approximately the last 5 years.

Numerous themes remind me of my own observations as in my aforementioned Drexel health IT difficulties site:

The implementation processes of the HSS [governmental Health IT support, a.k.a. Health Support Services - ed.] were criticised for refusing to acknowledge the validity of complaints, failing to fulfil promises, creating an ineffective change process, refusing to consult clinicians, using strategies to disenfranchise participation by clinical staff, and introducing a technology that doesnʼt fit their needs.

All of these themes are familiar to me, and are representative of the phenomena of non-clinician, IT-centric arrogant ignorance, paternalism, leadership-pyramid inversion (i.e., the facilitators thinking and acting as if they are the enablers of healthcare), playing nasty politics with clinicians to avoid work, and minimizing job and results-evaluation discomfort for those lucky enough to secure cushy IT jobs in health IT support.

In determining the clinical documentation needs of staff, the Directors claim that the HSS ignores the needs of staff. Directors report over-supply of irrelevant information and under-supply of needed information in the clinical interfaces. ["Legible gibberish" - ed.] The environment consists of counter-intuitive interfaces where data is entered by one person in one part of the system so that it is not discoverable by another person.

The interfaces have inappropriate sizing of objects, confusing functions, redundant steps, unused functions and cluttered interfaces. These difficulties have resulted in increased time usage on the system resulting in decreased time with patients for no gain in administrative or clinical outcomes. Staff minimise their use of the system to as little as possible with work arounds being constantly developed and improved. Staff morale has been clearly degraded with accompanying loss of respect for the HSS and more generally NSWHealth’s authority.

These concepts are described and illustrated in my multi-part essay on the healthcare IT mission hostile user experience at this link. They represent major deviations from good information science, information presentation and human-computer interaction (HCI) precepts.

... Workarounds in using the system are the most obvious tangible response of staff to the functions of the system they consider unsatisfactory. The key aspect of workarounds is that they constitute a subversion of the policy processes created by the software that the staff are not prepared to collaborate with. Some of these strategies may even compromise the legal status of the records in the system: such as not signing documents, unrecorded alterations to documents, and test results not attached to patient records.

... Another form of staff protest workaround is the strategy by staff to avoid using the system by either having other people [presumably underlings - ed.] do the work on the system, inserting minimal amounts of information thereby reducing the value of the information and passing information to other staff verbally.

Workarounds to IT obstacle courses and booby traps, as noted by Koppel, Wetterneck, Telles & Karsh in "Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety", J Am Med Inform Assoc. 2008 Jul-Aug;15(4):408-23, increase, not reduce, the risk of EHR-mediated medical errors. I wrote about their findings at "Business v. clinical computing: Workarounds to Barcode Medication Administration Systems" at this link.

It should be kept in mind that these are mission-critical systems for use in a fast-paced ED, not tracking systems for widgets - or for lab rats.

The lack of appropriate reporting functionality of the system has had a serious impact on the critical work of the Directors on process improvement ... It was evident in talking to the Directors that they have antennae highly tuned to the processes happening in their departments and the public health issues that emerge from their patients.

On a daily, weekly and monthly basis they review single cases, collections of common cases, and variations in established disease profiles to understand the success of their work and to detect emerging new trends or potential new disease outbreaks. At an administrative level they are asked to review cases either because of the return of new test results or due to complaints or reviews from other bodies.

The FirstNet installation has removed all the reporting functionality the directors had in their previous system EDIS while destroying their information sources for process improvement, and their mechanisms for creating and collaborating in research projects. This, in turn, has led to a loss of motivation to enter data further degrading the value of the data held within the system.

Reducing the value of a tool to people, and decreasing their ability to perform their jobs (especially when they take great professional responsibility and pride in those jobs) predictably leads to demoralization, demotivation and a cascading path down a whirlpool of failure.

The disadvantages of the system for day to day operations is well demonstrated by the issues around the ordering system. It is stated to be overly complex and requires a large deal of repetitive information to be input for multiple orders on one sample, plus specialist data entry knowledge that requires every joint order to have exactly the same timestamp. Ordering was the first accession where staff recognised that information is sometimes sent to the wrong staff, both arriving where it shouldn’t and not arriving where it should.

... Further mis-processing is seen with the cancellation of orders when a patient is transferred to a hospital ward from the ED. The results of orders, particularly radiology, often need to be checked by senior staff, but the system has no functionality to enable efficient processing of orders that have normal results, and thereby require no further attention.

I do recall another EHR system, by the same vendor I believe, where an "upgrade" in the recent past led to orders ending up in the wrong places (link):

... Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way.

The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.

[In other words, data entered by clinicians was going into the wrong charts. How many charts were involved? Does the hospital system even know, I wonder? - ed.]

Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.

Not to pick on this vendor; these "glitches" seem to be occurring in many HIT vendor's products.

All this, dear readers, is simply madness.

... Patient record retrieval is an important aspect of the staff work with patients, therefore its efficiency and accuracy is of vital importance to the activities of the ED. Staff were particularly pointed about the deterioration of this functionality in FirstNet compared to the previous system EDIS. [ED information system - ed.] There were cases where records could not be found, confusion about where data was stored in the patient record with different staff writing the same information into different parts of the record, and the [manual] rewriting of records [requiring a large amount of additional labor and time, not exactly a commodity in an ED -ed.] due to insertion of content into the wrong record.

These are critical issues. If you can't get information out of a computer in a timely fashion, what you have is a very expensive doorstop. I also note that a document imaging system that images hand written charts would not have these problems...

Prof. Patrick addresses the oft-heard canard that such complaints are the complaints of "Luddite doctors", old dogs who simply don't want to learn new tricks:

The staff in the ED are now generally experienced at using some form of clinical information system, many for over 10 years. This experience gives them a keen sense of what is possible with technology as well as the deficiencies in the existing systems. Combining this experience and knowledge with a sense of professional responsibility for process improvement enables them to judge quite acutely when a system is well designed or not. Hence their observations about elements of systems that are not parsimonious enough for optimal clinical efficiency deserve to be respected.

That it even needs to be written that the opinions of experienced medical professionals on the tools they are coerced to use by non-medical outsiders "deserve to be respected" gives testimony to my observation of a cross-disciplinary invasion of healthcare by the IT profession (among others).

Workflow and dataflow and the continuity of these processes are vital to the smooth running of a complex socio-technical process. ED staff have shaped these flows over a period of years and socialised all staff into the streaming. The directors have found that with the workflow of staff needing to use both clinical and nursing notes at the same time, their separation in FirstNet is deleterious. One department considered that the many nursing and medical notes accumulated over a day had to be kept in a single continuous sequence in the clinical record. Their workaround was to keep the one note page open for 24 hours to maintain the needed continuity in the patient record and avoid staff using a significant amount of time at the computer searching for needed information.

Nemeth and Cook explain how an ED EHR can be developed and marketed that interferes with, not supports, the workflows common in ED"s worldwide, in "Hiding in plain sight: What Koppel et al. tell us about healthcare IT", J Biomed Inform. 2005 Aug;38(4):262-3:

... On the surface, healthcare work seems to flow smoothly. That is because the clinicians who provide healthcare service make it so. Just beneath the apparently smooth-running operations is a complex, poorly bounded, conflicted, highly variable, uncertain, and high-tempo work domain. The technical work that clinicians perform resolves these complex and conflicting elements into a productive work domain. Occasional visitors to this setting [i.e., IT personnel, non-medical bureaucrats, etc. - ed.] see the smooth surface that clinicians have created and remain unaware of the conflicts that lie beneath it.

The technical work that clinicians perform is hiding in plain sight. [Hiding from the uninformed, that is - ed.] Those who know how to do research in this domain can see through the smooth surface and understand its complex and challenging reality. Occasional visitors cannot fathom this demanding work, much less create IT systems to support it. Progress in healthcare IT systems relies on scientific data on the actual, not the perceived, nature of day-today operations.

It increasingly seems the only place the faux-expert, healthcare-facilitor, cybernetic snake oil salespeople are going ot learn this simple lesson is in the courtroom...

A recent article in the press has presented evidence that access block times in EDs across the state of NSW are worsening.

As regards causality, it perhaps takes being an IS dept. director in a hospital - or holding elected office - to be unable to recognize the nose at the front of one's face.

Prof. Patrick wraps up this section of his forensic analysis as follows:

A number of conclusions can be drawn from the study:

1. Staff are entirely dissatisfied with the SBB and they feel that the deliverables have significantly failed to match the promises.

2. The Directors see that the HSS have failed in their support of the frontline of emergency care across the Sydney basin and their practices are decidedly lacking in proper engagement with the user community which should be their primary concern.

3. Some of the consequences of the HSS decision not to provide the reports needed by the Directors have lead to them being seriously hampered in being able to monitor the quality of their own department’s practices and wider changes and trends in community health.

4. The inefficiencies introduced by this technology have lead to a litany of complaints about its behaviour that have gone unheeded over the past three years.

5. It has lead to major strategies to work around the system by staff at all levels, to the point of complete avoidance by some staff.

The major consequences of these failings in the eyes of the ED directors are:

• Lost productivity and inefficiencies,
• Increased risks to patients,
• Disillusionment of staff and loss of morale.

Considering my own mother's blown cerebellum originating in an ED EHR mishap, I think I can safely add to Prof. Patrick's final tally an additional item:

• Patients have been harmed.
  

This is not a pretty picture.

I'm confident the Australian legal system abhors negligence as much as our own here in the U.S. If patients are injured and/or die as a result, considering that the Programme leadership and IT vendors knew - or should have known - of these deficits, it would not surprise me if criminal negligence charges begin to appear.

These issues are not exactly rocket science, and an expanding literature base has been appearing in recent years. See, for example, my recent post "An Updated Reading List on Health IT" at this link.

I can only add that my own mother was nearly killed as a result of a number of the phenomena described in Prof. Patrick's analysis.

More on other sections of his report at another time.

-- SS

March 6, 2011 addendum:

Also see my new post "What to do about the state of the ED EHR in NSW?"

-- SS

Mar. 8, 2011 addendum:

Prof. Patrick has added a new section to his report, entitled "The Future Pathways for e-Health in NSW." It is available at this link (PDF).

It inoculates against most of the 'Ten Plagues' that bedevil health IT projects (such as the IT-clinical leadership inversion, magical thinking about the technology, and lack of accountability):

More on the Pathways at my post here.

The de facto "National Program for IT in the HHS" here in the United States needs a similar inoculation.

--SS

Here Comes the Judge! A Quick Thought on Cybernetic Medicine: Why Can't Computers Also Do Law?

At my Jan. 2011 post "IBM's Watson, Jeopardy, and Revolutionizing Medicine" I lamented that with every new computer advance since the 1950's, soon to follow was a prediction of cybernetic advancements in medicine, such as this:

... A Watson-like system can take that information and co-relate it against all the medical journals and relevant information, and say, "Here's what I think and why," while showing its evidence for how it came up with the conclusion, according to Frase [vice president of industry solutions and emerging business at IBM Research].

The following recently occurred to me in the early morning hours as I watched the sun rise:

I wonder why there are no suggestions of replacing lawyers with computers.

After all, a Watson-like system can take lawsuit information and co-relate it against all the legal journals and relevant information, and say, "Here's what I think and why," while showing its evidence for how it came up with the conclusion. No need for lawyers and their cognitive processes and judgment!

Right?

The judge could be replaced by a cyber-judge. Judge Alex and Judge Judy, you've met your match. Here comes the cybernetic judge...

Order in the Court, Cause Here Comes the Judge! Click to play video.

A set of Watson-like systems could even serve as a jury, being capable, as we know, of flawless human judgment.

... The jury findings, your honor Judge Watson are:

Bob Watson: defendant is guilty by algorithm.
Mary Watson: defendant is guilty by algorithm.
Judy Watson : defendant is guilty by algorithm.
Frank Watson: defendant is guilty by algorithm.
Tom Watson: defendant is ... xoxooxo1011001%$&#@#

(Oops, sorry, your cybernetic Honor, Tom's primary CPU crashed.)

Think of the possibilities...

Perhaps Watson could even be programmed to, say, determine if a proposed law is constitutional or not? No more Supreme Court!

Like medicine, cybernetic practice of law should be child's play, no?

-- SS

Thanks to the wonders of EHR, this premature baby went to the grave, prematurely

Thanks to the distractions of EHR and the wonders of EHR auto entry, cut and paste etc., this premature baby went to the grave, prematurely:

Failures in care alleged after premature birth - $1,000,000 Settlement

By Virginia Lawyers Weekly
Published: October 18, 2010

Tags: Fairfax County Circuit Court, Medical Malpractice, Million-Dollar Settlements

Decedent and his twin sister were born healthy at 27 weeks gestation. Decedent was placed in the neonatal intensive care unit. Six days after birth, a peripherally inserted central catheter (PICC) was inserted into the right axilla and used to infuse nutrition, medication, blood products and lipids.

Within 48 hours, the PICC insertion site began to show evidence of compromise. The attending physician gave a verbal order to monitor the arm, but the order was never reduced to writing and no monitoring of the site was thereafter documented in the chart. Indeed, a comparison of the IV site care notes with the nursing notes revealed the use of an automated entry feature, confirmed by the defendants in discovery, which permitted the nursing staff to simply re-enter prior descriptions of a patient’s condition.

[Transforming medicine, one thunderous mouse click at a time, as expressed by the former HHS secretary. As at this link on EHR risks re: copy and paste, "Another pitfall seen in litigation is the situation of an incorrect history or physical finding that is documented repeatedly in the medical record. This frequently occurs in the in-patient setting but can occur in the outpatient setting as well." - ed.]

As a result, the nursing notes continued to describe the condition of the affected arm as normal when in fact it was continuing to visibly deteriorate. Thereafter, despite swelling and seepage at the PICC insertion site and discoloration of the hand, the PICC was not removed for an additional 48 hours. The decedent was flown to another facility where the right arm was amputated after becoming necrotic and gangrenous. The infant died after 36 days of life. Plaintiffs sued the nurses, hospital and neonatal specialists charged with the decedent’s care.

Plaintiffs’ experts were prepared to testify that it was a departure from the standard of care for the physicians and nurses to fail to monitor the PICC insertion site and promptly remove the line when evidence of compromise and vascular damage developed.

[That's a no-brainer. Were these clinicians distracted by EHR clerical data entry duties, I wonder? - ed.]

They would have further testified that these departures caused a cascade of events leading to necrosis of the arm, the onset of gangrene and eventually staph sepsis, which killed the decedent.

The plaintiffs’ wrongful death claim was primarily for loss of solace. The decedent was survived by his parents and three siblings, including his fraternal twin. The decedent’s twin is now a healthy 2-year old who is meeting all normal developmental milestones.

[10-T-153]

Type of Action: Medical malpractice
Injuries Alleged:
Name of case:
Court: Fairfax County Circuit Court
Tried before:
Name of judge/mediator:
Special Damages:
Verdict or Settlement:
Amount: $1,000,000
Date: Sept. 17, 2010

Plaintiffs’ attorneys: Infant death Confidential Mediation Johanna L. Fitzpatrick $584,000 in medical expenses (contested by defendants) Settlement H. Jan Roltsch-Anoll, Woodbridge; Tracy C. Hudson, Manassas

What a tragedy.

-- SS

"A Study of an Enterprise Health information System" - Finally, an Informatics Scientist Does A Rigorous Review of a Commercial EHR System, by Cerner

Australian professor Jon Patrick, who I wrote about at this blog in the past such as at my Nov. 2009 post "Academic Freedom and ED EHR's Down Under: An Update", has written what I consider the first truly serious, rigorous evaluation of a commercial EHR system.

He has evaluated the Cerner FirstNet ED EHR, being 'forced' on hospitals in the Australian state of New South Wales by their government.

His evaluation is entitled "A study of an Enterprise Health information System" and was released on March 4, 2011.

In my view, all current EHR's should undergo this level of scrutiny and critique.

His multi-part analysis, down the the level of the data schema, speaks for itself.

The report is at: http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146

or download directly from: http://www.it.usyd.edu.au/~hitru/essays/Study%20of%20Enterprise%20Health%20IS%20-%20Parts%200-9%20PDF-ARCHIVE.zip [Note: this is a 12 Mb .zip file].

Summary:

This is a study into the roll-out of Cerner FirstNet into EDs in NSW. The original study was issued in Dec 2009 (Part 3.1). This has been added to with a new study in 2010 consisting of discussions with 7 ED Directors (Part 3.2), discussions with software experts who do performance evaluations on Cerner sites (Part 3.3), and reviews of Entity-Relationship Diagrams (Part 3.4), Schema descriptions and data tables from customer installations (Part 3.5 & 3.6). All this information is coalesced to establish a much more detailed picture of a Cerner installation (Part 3.7). A number of weaknesses are identified in the design and implementation and risk assessments are recommended for organisations using this software or intending to use it. Regulations that might minimise the risks to users of health software are recommended (Part 3.8). An alternative architecture and method for constructing clinical information systems is presented (Part 3.9).

The .zip file contains the following files:

3.0 Part 0 - Executive Summary
3.1 Part 1 - A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck? First published here in Oct 2009, revised Dec 2009.
3.2 Part 2 - Discussions with ED Directors: Are we on the right track?
3.3 Part 3 - Discussions with Software Performance Experts.
3.4 Part 4 - Conceptual Data Modelling.
3.5 Part 5 - Database Relational Schema and Data Tables.
3.6 Part 6 - Coalescing the Analyses of the ER Diagrams, Relational Schemata and Data Tables.
3.7 Part 7 - The Integrated Assessment.
3.8 Part 8 - Future HIT Regulation Proposals.
3.9 Part 9 - Ockham's Razor of Design. Published at the IHI conference, Nov 2010 Washington.

A non-technical but revealing summary from Part 2:

Discussions were held with the Directors of 7 Emergency Departments in New South Wales (NSW) public hospitals assessing the impact of the introduction of the FirstNet information system into their Departments. All but one of the Directors has found that the system has had a deleterious impact on their department’s clinical work. The range of problems reported indicate that whilst the software is not fit-for-purpose, many of the problems are created or exacerbated by attitudes of the NSW Health IT support, Health Support Services (HSS). In most departments it was reported that staff have developed significant strategies for minimising and circumventing the use of the system. The Directors are frustrated by the lack of a reporting functionality that disables their ability to monitor their own department’s performance. Most Directors report an increase in the time required to deal with patients and therefore a deterioration in access block times. This has been masked by changes in the way this time has been redefined by NSW Health. Overall, most perceive that in moving from their previous information system EDIS to FirstNet they and their patients have suffered. Most Directors are resigned to the fact that no improvements will be made to the current performance of the system due to its inherent inadequacies and the attitude of HSS. A consequence of the ED Directors critique leads inevitably to the debate on the merits of enterprise wide systems versus best-of-breed systems. Emerging from these issues are criteria for a new technology for creating clinical information systems.

I will have more to say on this study later. I have to take my ED EHR-injured 85 year old mother to the doctor. (Note - the culpable system was not by this vendor).

-- SS

Morgan Stanley, Victim of “Operation Aurora”

Recent developments revealed that Morgan Stanley, a global financial services firm, was hit by the infamous “Aurora” hackers of 2009. The details of said hack were disclosed through leaked HBGary emails.

Operation Aurora gained notoriety when Google publicly announced last January 2010 that it had been a victim of cyber attack, and disclosed that the attacks originated in China. Other researchers inferred from the sophistication of the attack that the Chinese government may have sanctioned, or even masterminded the operation.

Morgan Stanley and Google are not the only ones breached by these hackers. At least 20 more companies have been identified as targets of Operation Aurora. In regards to these findings, the US government is requesting China for a formal explanation. 

Hospital: "While We're the Bee's Knees in IT, We Aren't Perfect And We Are Always Willing To Look In The [Smashed Up, Rear-View] Mirror"

In response to my post "A Brief Primer on Health IT Problems" which I cross-posted to the site EMRUpdate.com, I received this response from another physician at this link:

I engage the so called "IT physician leader", who is non clinical in our hospital system. She told me that this is the "future", even before I could express my concern of work flow disruption with the Cerner system we have. Not realizing that I have an EMR for 11 years. You would think these pundits would ask assistance or input from successful implementers, but they are too arrogant and proud! It is frustrating to say the lease.

It takes 2 to 4 times longer to rounds and navigate the system. Then they wonder why the patient satisfaction on their floors waxes and wanes. Priorities shifted to documentation, that makes the system received accolades from organizations I never heard of till the last 10 years.

I replied as follows:

Re: I engage the so called "IT physician leader", who is non clinical in our hospital system. She told me that this is the "future", even before I could express my concern of work flow disruption

Please feel free to submit my full Reading List to your organization's Board of Directors, along with questions as to exactly why it is "our future."

Re: You would think these pundits would ask assistance or input from successful implementers, but they are too arrogant and proud!

You are right on the money to an extent even you may not realize.

Sir, here's the reply I received from the CMO at the hospital where my mother was nearly killed by EMR-caused error, in response to my confidential, explicit, two-page warning letter a month before the catastrophe about EHR deficiencies I'd been observing in my mother's care. I sent the letter to the CMO and the CEO confidentially, as a favor. My letter concluded that "if these problems are left unremediated, patients may be harmed."

The response:

Dear Scot, I had received and read your email and elected, in view of the extraordinarily unproductive discourse we have had in the past between yourself and a number of the professional staff** [see note below - ed.], that it was best not to engage. I thank you for the courtesy of a copy of your letter to the CEO and I remain extremely proud of the past and ongoing accomplishments of our Clinical Information Systems leadership and staff.

** NOTE: ['unproductive discourse' translation: bureaucratese for "discourse" appx. two years prior with the non-medical CIO regarding what constitutes good Medical Informatics practices, and with the CMO himself who'd paradoxically opined that informatics-educated physicians (like myself) were not the 'sine qua non' of healthcare informatics projects - ed.]

In other words, you are not an expert, we are; your warning letter sucks, and go Bug Off.

Remarkably and (sadly) ironic, in another time and place in the 1980's when we had worked together, this same physician now telling me to bug off had written me glowing recommendation letters extolling my computer expertise, which ultimately helped me secure a Yale postdoctoral fellowship in Medical Informatics. Now I was telling him his current hospital had a problem; his reaction - we don't think so, there's nothing you can teach us, in fact we're the Bee's Knees in IT.

His own "physician IT expert" (sans any professional computer or informatics education or experience I could discern), I learned, had settled a malpractice suit involving the death of a young person with an in-your-face, rip-roaring soft tissue infection, with a WBC (white blood cell) count exceeding 20,000 but sent out of the ED without antibiotics, for appx. $1.5 million dollars.

I only wish I had made all this up.

One month later, my mother was nearly dead-by-EMR, ironically due to almost the same issues as in my confidential warning letter. She remains crippled nearly a year later.

I ask readers to suggest an appropriate adjective describing those responsible...

-- SS

p.s. after the accident, the CMO sent me this:

"We are not perfect and we are always willing to look in the mirror"

Gee, thanks, I thought, the needlessly-broken rear view mirror of the wrecked car, with my mother in extremis after huge cerebral hemorrhage and emergency craniotomy.

This story is so tragic, and so revealing of hospital IT and clinical leadership arrogance and "pride", I am considering writing a book on the episode. I view it as a civic duty in protecting the health of the public from EHR risks. There's quite a lot more to tell.

-- SS

HIMSS and Healthcare IT: We Don't Need A "Usability Maturity Model." We Need - USABILITY - and Less of Cold-Blooded Calculus

Health IT industry consortium HIMSS has followed up its Master of the Obvious, 50-years-too-late paper "Defining and Testing EMR Usability: Principles and Proposed Methods of EMR Usability Evaluation and Rating" (June 2009) that I wrote about in a Dec. 2010 post "Unintended errors with EHR-based result management: a case series, and a special pleading for health IT" with a new report:

Promoting Usability in Health Organizations: Usability Maturity Model (PDF, Feb. 2011)

I knew I was in for a heaping helping of gobbledygook after reading the title itself:

“Promoting Usability in Health Organizations: Initial Steps and Progress Toward a Healthcare Usability Maturity Model”

A “Healthcare Usability Maturity Model” is a clue that what follows will take simplicity, and expend considerable ink to tangle it into a mess of process mysticism, buzzwords, paradigms, very pretty charts, and other Master-of-the-Obvious-made-to-look-sophisticated, destined-for-the-dusty-shelf consultant report.

That is largely what follows. See for yourself.

This passage in the Executive Summary is pathognomonic of the amoral, money-over-blood, patients-as-guinea-pigs mentality that inhabits the commercial health IT sector. I find it particularly revealing and revolting:

... Leaders may be reluctant to incorporate usability principles and practices [in a safety-critical technology increasingly mediating all aspects of medical care delivery - ed.] because of perceptions that these methods may slow development and product fielding. However, data exist on usability return on investment (ROI), outlining the value of adopting usability in health organizations.

Excuse me? It takes proof of "ROI" to convince these companies to produce usable (which subsumes the concept of "safe") health IT?

This is as cold-blooded a calculus as it gets. This is Ford Pinto material:

... Critics alleged that the vehicle's lack of reinforcing structure between the rear panel and the tank meant the tank would be pushed forward and punctured by the protruding bolts of the differential^[15] [by a rear end collision of only 20 mph/32 km/h, causing a fire - ed.]— making the car less safe than its contemporaries.

According to a 1977 Mother Jones article, Ford allegedly was aware of the design flaw, refused to pay for a redesign, and decided it would be cheaper to pay off possible lawsuits for resulting deaths. The magazine obtained a cost-benefit analysis that it said Ford had used to compare the cost of an $11 repair against the monetary value of a human life—what became known as the Ford Pinto Memo.^[13][16][17]

An example of a Pinto rear-end accident that led to a lawsuit was the 1972 accident that killed Lilly Gray and severely burned 13-year old Richard Grimshaw. The accident resulted in the court case Grimshaw v. Ford Motor Co.,^[18] in which the California Court of Appeal for the Fourth Appellate District upheld compensatory damages of $2.5 million and punitive damages of $3.5 million against Ford, partially because Ford had been aware of the design defects before production but had decided against changing the design.

[In more recent years, others said the Ford Pinto scandal was not clear-cut, but health IT unusability increasing odds for medical errors is clear-cut - ed.]

Why are these companies and their leadership getting to play God - in a field such as Medicine?

Usability? Those Luddite doctors and crummy patients will get usability over my - er, their - dead bodies, if I don't profit handsomely from it.

Finally, I have several meta-observations about this new report:

• We don't need a "usability maturity model." We need USABILITY. We need the common and longstanding knowledge of software usability in other mission critical sectors to be applied on the development whiteboard and usability testing labs (if any!) at HIT vendors.
  

• Why is it that health IT usability has to be written about, basically as if from the grade school level, in 2011 - some sixty years into the “computer revolution?” Do we still write treatises on why it’s wise to use sterile technique and good lighting in operating rooms? What is the major malfunction in this industry?
  

• Why is this treatise not entitled “Promoting Usability in Health IT Vendor Development Shops: A Vendor Responsibility Model”?

• The frequent use of the terminology "user experience" as applied to healthcare IT in this report struck my eye. It has been adopted in this report, but was uncommon regarding health IT until recently, as in my posts about the health IT mission hostile user experience.
  

The terminology is conspicuously absent in the aforementioned earlier 2009 HIMSS report. It would not take Sherlock Holmes to theorize that I might be an unattributed contributor to the new 2011 HIMSS report. If anyone knows differently, I'd be interested to hear about it.

-- SS

Vladimir Putin and Common Sense on IT

Vladimir Putin may be known for showing off his pectorals riding horses bare chested, but he also seems to have a substantial amount of gray matter between the ears.

Our country, including the healthcare IT sector, could probably learn something from him:

A Walled Wide Web for Nervous Autocrats
Wall Street Journal
Jan. 8, 2011

By EVGENY MOROZOV

At the end of 2010, the "open-source" software movement, whose activists tend to be fringe academics and ponytailed computer geeks, found an unusual ally: the Russian government. Vladimir Putin signed a 20-page executive order requiring all public institutions in Russia to replace proprietary software, developed by companies like Microsoft and Adobe, with free open-source alternatives by 2015.

The move will save billions of dollars in licensing fees, but Mr. Putin's motives are not strictly economic. In all likelihood, his real fear is that Russia's growing dependence on proprietary software, especially programs sold by foreign vendors, has immense implications for the country's national security. Free open-source software, by its nature, is unlikely to feature secret back doors that lead directly to Langley, Va.

It's also less likely to feature a backdoor to a hacker's basement, or a lot of bugs ("glitches") that some health IT vendors and customer organizations allow to accumulate into the thousands before lifting a finger.

This brings to mind the adage that "if you want something done right, do it yourself."

... For ordinary Internet users, there is one silver lining: The embrace of open-source technology by governments may result in more intuitive software applications, written by a more diverse set of developers.

[Read the whole article at the link above - ed.]

More intuitive IT applications could solve a lot of the current health IT problems, such as the mission hostile user experience of many closed-source products from major vendors.

Afrer major IT debacles including the £13 billion abyss of the National Programme for IT in the NHS (NPfIT), the UK also seems to be learning:

New approach urged for government IT
E-Health Insider

2 March 2011
Lyn Whitfield

A new report into government IT failures has warned that previous inquiries may have embedded problems by focusing on inappropriate ‘best practice’ instead of looking for alternative approaches.

The report, from the Institute for Government, says “existing ‘best practice’ project models do not deal with the fundamental issues at the heart of government IT.”

[As I've stated here, one has to consider the "worst practices" as well, the "thou shall not's." Typical Milquetoast, touchy-feely "best practices" models and their "sanitized accounts of successful projects" (cf. Greenhalgh et al.) avoid such inconvenient realities like the plague - ed.]

It also argues that: “By implementing these same, flawed project techniques in an increasingly rigid fashion, these traditional solutions can act to exacerbate the problems further.”

[This sounds familiar, typical of the inflexible, dogmatic business IT culture, descended from the punched-card programmable tabulator culture of the 1920's - see this link - ed.]

Instead, it calls for a new that focuses on using government’s huge buying power to get better deals for what it calls ‘platform' technologies – such as server capacity and PCs – while encouraging departments to adopt ‘agile’ methodologies to deliver systems to meet the particular challenges they face.

... Andrew Adonis, Director of the Institute for Government said: “The billions spent on cancelled IT projects, such as ID cards and National Programme for IT in the NHS, demonstrate precisely why we need a much more flexible approach to government IT.

... The report cites the national programme as one ‘symptom of failure’ in government IT; the tendency for projects to run late and for departments to struggle to keep suppliers on board or hold them to their original delivery requirements as a result.

Agile software development methodologies have traditionally been anathema to the culture of IS departments involved in mercantile, manufacturing and management varieties of business computing. As I've written many times, however, those methodologies are essential in healthcare IT, such as here and here. At the latter link I observed:

... In fact, in my observations IT personnel are the true Luddites [as opposed to clinicians who are often accused of that reactionary characteristic- ed.], clinging to inappropriate, rigid business-IT views on the healthcare IT development and implementation process (vs. more appropriate and modern agile methodologies), holding unshakable, stereotypical views about physicians, and remaining unreasonably obstinate on clinician complaints about "clunky" health IT user experiences.

Perhaps Mr. Putin and Mr. Adonis deserve a copy of the book "Medical Informatics 20/20: Quality And Electronic Health Records Through Collaboration, Open Solutions, And Innovation", Jan. 2007, by the VistA (open-source EMR) pioneers.

The "Open Solutions" part of that title says it all.

-- SS

IOM Committee on Patient Safety and Health IT, Meeting Two: Institute of Medicine, or Institute of Mediocrity?

In my Jan. 2011 post "Institute of Medicine Committee on Patient Safety and Health Information Technology, and Thoughts on Social Aspects of Health IT Evaluation" I wrote that:

The U.S. National Research Council of the National Academy of Sciences issued a report in early 2009 on the state of health IT. That study's report, led in part by pioneers in Medical Informatics G. Octo Barnett and William Stead, was entitled "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions" (pre-publication PDF available free at this link). The report was announced under the following header:

CURRENT APPROACHES TO U.S. HEALTH CARE INFORMATION TECHNOLOGY ARE INSUFFICIENT

The insufficiencies were largely in the areas of difficulties with data sharing and integration, deployment of new IT capabilities, large-scale data management, and lack of cognitive support by health IT for busy clinicians.

One might reasonably conclude such deficits could affect patient safety.

Recently the Institute of Medicine (the health arm of the National Academy of Sciences) formed a Committee to study health IT safety. It held its first meeting on Dec. 14, 2010 (quite a few years late in my opinion, and only after tens of billions of dollars have been earmarked for health IT, but better late than never):

The Institute of Medicine Committee on Patient Safety and Health Information Technology is holding its first meeting on December 14-15, 2010. The first day, December 14, 2010 beginning at 10:30 am, is open to the public to observe the committee proceedings. The committee will hear presentations by the Office of the National Coordinator and other invited guests. There will also be an opportunity for members of the public and representatives of interested organizations to make a brief statement before the committee. Prior registration is requested for attendees and required for those wishing to make a statement.

Here are links to the PPT presentations from Meeting 2 of the Committee on Patient Safety and Health IT that took place Feb. 24, 2011:

http://www.iom.edu/~/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Dwork.pdf

http://www.iom.edu/~/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/WoodsNormanFeb2011.pdf

http://www.iom.edu/~/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Harper%20IOM%20HIT%20Patient%20Safety.pdf

http://www.iom.edu/~/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Chrisman-.pdf

http://www.iom.edu/~/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Palmer.pdf

The PPT's can be downloaded directly from these links.

I note several observations:

• The overall quality of these presentations appears mediocre;

• Issues of healthcare IT risks - as they exist on the ground in 2011 - are addressed poorly if at all;
  

• Proposed "solutions" are really nothing novel or new compared to existing literature or recommendations made in earlier studies, including that of the US NRC;

• That these presentations come from the highest scientific body in the United States is, in my opinion, a disappointment and, indeed, an embarrassment.

The IOM's rules of engagement, according to the Study Director, preclude my testifying, as a Medical Informatics specialist and former CMIO, about my mother's nearly being killed by poorly designed and implemented health IT. Instead, the linked presentations above are presented.

Here's an example of what I consider a somewhat rigorous and critical thinking-based presentation on health IT risks:

http://www.ischool.drexel.edu/faculty/ssilverstein/Clinical_IT_benefits_risks.ppt

I think the IOM should be able to do better than a mere small-university medical informatics adjunct professor.

-- SS

Once More with Feeling: Another Defense of Conflicts of Interest Based on Logical Fallacies

Despite increasing recognition of the adverse effects of health care professionals' and health care institutions' conflicts of interest on health care, such financial relationships continue to have their prominent defenders.  The latest example was an article in Medscape General Surgery by Frank J Veith MD, entitled "Physicians and Industry: Fix the Relationships, but Keep Them Going."  Dr Veith is a prominent vascular surgeon who "received numerous awards and honors as a leader, outstanding teacher, and innovator in vascular surgery," according to New York University

We have noted before how defenders of conflicted professionals and professional societies often employ logical fallacies to support their arguments.  Some recent examples were discussed here, by a prominent ostensibly libertarian attorney and law professor; here, published in a well-known medical journal by the former director of "medical communications" for a large pharmaceutical firm; and here, by the president of a large medical society, published again in a well-known medical journal.

Dr Veith seems to be continuing that tradition. His approach emphasized frequent repetition of the same fallacious argument.

Straw Man: "Totally Interrupt All Doctor-Industry Relationships"

Dr Veith's main argument seemed to be with attempts to prevent physicians from having any relationships with industry, presumably including not just financial relationships, but professional collaborations or even personal friendships.  For example, he wrote about

a recent initiative to completely sever the relationship between industry and doctors has gained traction. This initiative has been supported by several states, including Massachusetts and Vermont, and universities, such as Harvard, Stanford, the University of Massachusetts, and the University of Michigan, which have enacted draconian laws or policies designed to separate doctors and industry and to interrupt any relationship between them.

Furthermore,

Even many individual physicians have sanctimoniously jumped on the bandwagon and written articles or opinion pieces attacking the evils of any relationship between industry and doctors, suggesting the severance of any such relationships.

Then later, Dr Veith wrote,

We should establish rules to prevent or minimize the abuses, but we should not totally interrupt all doctor-industry relationships. To do so is wrong-headed and would eliminate the many beneficial effects that accrue to medical care and society from these relationships. It would be throwing the baby out with the bathwater.

Finally, he concluded thus,

These will be far better solutions than completely eliminating all industry-doctor relationships.... Such safeguards will be better than the present trend for institutions and governments to enact strict measures to separate physicians from industry.

Despite making this argument at least four times, the problem is that Dr Veith provided no citations, much less evidence that such "draconian" policies have been enacted or even advocated.

There have been new policies on conflicts of interest suggested or adopted by some organizations. None, to my knowledge have been exactly "draconian."

For example, Harvard University does have a new policy on conflicts of interest. Maybe Dr Veith was referring to it above when he mentioned Harvard. However, in an interview about the new policy involving university leaders published in the Harvard Gazette, the Vice Provost of the University said,

The University is not designed to be an ivory tower isolated from the world. So the trick is to be able to have a robust system for affording faculty opportunities to engage with the commercial world and at the same time not threaten in any way their own fundamental integrity or that of Harvard.

That hardly sounds like a policy that completely severs all relationships between faculty and industry.
So Dr Veith's main premise seems to be based on a multiply repeated straw-man argument. He argued again and again against a policy that no one seems to be advocating. (And even I, as a hard-liner about conflicts of interest, have never advocated a complete interruption of all relationships of any kind between all physicians and all of industry.)

Appeal to Fear: You Will be "Blighted"

Perhaps just to spice things up, Dr Veith warned of the dire consequences of the "draconian" policies that no one was advocating:

Those institutions that choose such inquisitional approaches will be blighted and suffer competitive disadvantages.

Dr Veith had asserted multiple benefits of continuing relationships among physicians, health care institutions, and commercial firm. He presented no evidence to support his assertions, most of which can be questioned (see below). His warning that institutions will be "blighted" was based on his assertion that the stringent policy no one advocated would eliminate these unproven benefits, hence his warning of  something so severe as "blight" seemed to be an appeal to fear.

Ad Hominem: "Sanctimonious" Physicians Leading a "Witch Hunt"

As noted above, Dr Veith referred to anonymous physicians who "sanctimoniously jumped on the bandwagon," thus leading to

The initiative to separate industry from physicians and surgeons [which] has taken on the trappings of a witch hunt.

And again,

Their leaders should recognize this and resist the temptation to join the separation witch hunt....

My interpretation is that this was an implied set of ad hominems. Those who supposedly advocated the "draconian" policy were made out to be "sanctimonious" witch hunters. After just having seen "The Crucible," I could also argue that the use of the term "witch hunt," with its current extreme emotional references (apparently to a case in which presumably innocent people were hanged), amounted to an appeal to emotion and an appeal to fear.

Summary

I must admit Dr Veith's entire set of arguments was not completely based on logical fallacies.  However, the rest of his arguments hardly appeared even-handed.  He presented a series of assertions about the benefits of such relationships, including that they "foster innovation and development," that "industry-sponsored medical education helps to keep physicians informed about new developments," that industry sponsored education about devices prevents "difficult and dangerous" practices, and helps physicians use devices "better and more safely."  He provided no evidence in favor of these claims, and seemed to ignore arguments about the hazards of payments to physicians biasing their clinical practice, teaching and research.

I should also note that these arguments were made by a physician who appears to have his own personal financial relationships with industry.  In the Medscape article, Dr Veith "disclosed no relevant financial relationships."   However, as a member of the editorial board of Medscape General Surgery, Dr Veith "disclosed the following relevant financial relationships: Owns stock, stock options, or bonds from: Vascular Innovations, Inc."  Furthermore, the disclosure summary for the iCON2011 conference includes the following for Dr Veith, "Honorarium/Expenses: Cook Medical, Cordis, WL Gore, Medtronic." Finally, Dr Veith apparently runs the Veith Symposium, which in 2010 acknowledged the following commercial sponsors: Aastrom, Abbott Vascular, Aptus Endosystems Inc, Atrium, Bard Peripheral Vascular, Boston Scientific, Cook Medical, Cordis Cardiac and Vascular Institute, Delcath Systems Inc, Gore, Hansen Medical, Lombard Medical Technologies, Maquet, Medtronic, Organogenesis Inc, Sanofi-Aventis, St. Jude Medical, Tenaxis Medical, Triavascular, Vascutek Terumo.

So Dr Veith's article continues the tradition of defenses of physicians' and health care institutions' conflicts of interest based on logical fallacies and unbalanced and unsupported assertions.  Also, note that all the examples of such defenses we have discussed were made by people with their own financial relationships with drug, device, and/or biotechnology companies, although some of them disclosed these relationships.  I have yet to see a defense of such conflicts based on logic and evidence, or a defense of such conflicts made by someone who has absolutely no conflicts of his or her own. 

The currently prevalent relationships with health care corporations among academic physicians, researchers, and other decision makers and influencers in health care have been lucrative for them.  I have yet to see a coherent, logical argument that these relationships are good for patients, medical education, biomedical or clinical science, or public health made by anyone, much less someone who does not have such relationships.

I will note that the defenses of conflicts of interest begin to seem drearily similar.  Not only do they often use the same logical fallacies, but they repeat the same stale and unsupported arguments about the benefits of financial relationships with industry: that they foster "innovation," and that they provide better educational opportunities than unconflicted programs and educators.  We now know that the managed care industry has engineered stealth health policy advocacy campaigns that furnish talking points to "third parties" which may get caught up in the larger policy discourse (see posts here and here).  I wonder whether some such stealth health policy advocacy campaign by pharmaceutical, device and/or biotechnology companies seeded the discourse about conflicts of interest with some of the logical fallacies and unproven assertions that have become so familiar. 

We need to elevate our discourse about health care policy.  People involved in health policy discussions should at least disclose their conflicts of interest when making their points.  We should be very skeptical of  arguments and look carefully for the evidence and logic that supports them.  When we find that evidence and logic is lacking, be even more skeptical about who benefits from them.