Health IT Ten Commandments (1970) v. Health IT Truisms (2012)

In 1970, health IT pioneer Dr. Octo Barnett at Harvard/MGH wrote his "Health IT Ten Commandments" (from Collen's "A history of Medical Informatics in the United States, 1950-1990"): 

1. Thou shall know what you want to do

2. Thou shall construct modular systems - given chaotic nature of hospitals

3. Thou shall build a computer system that can evolve in a graceful fashion

4. Thou shall build a system that allows easy and rapid programming development and modification

5. Thou shall build a system that has consistently rapid response time and is easy for the non-computernik to use

6. Thou shall have duplicate hardware systems

7. Thou shall build and implement your system in a joint effort with real users in a real situation with real problems

8. Thou shall be concerned with realities of the cost and projected benefit of the computer system

9. Innovation in computer technology is not enough; there must be a commitment to the potentials of radical change in other aspects of healthcare delivery, particularly those having to do with organization and manpower utilization

10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.

Four decades later, I write the following 2012 "Health IT Truisms" (perhaps more to follow).  Many of the points summarized here can be found in the past 8 years of my writing on this blog:

1.  Health IT in 2012 remains experimental, not proven effective or safe, with actual results conflicting.

2.  Health IT is costly, not money-saving, diverting scarce healthcare resources away from actual healthcare provision to the IT industry.

3.  "EHR" is an anachronistic term (that disarms the uninformed, who "see" an innocuous file system)  for what is now an enterprise medical resource and workflow control system.

4.  The proper framework in which to view "resistance" to health IT is not Luddite clinicians vs. IT modernists.  It's pragmatist clinicians (with ethical and legal obligations and responsibilities), vs. IT hyper-enthusiasts who ignore or are blinded to the ethical considerations and downsides, and whose actions are based not on science, but on faith in technology and self interest.

5.  HIT can be partitioned into good health IT (GHIT) and bad HIT (BHIT) - see definitions at the introduction to  http://www.ischool.drexel.edu/faculty/ssilverstein/cases.

6.  BHIT prevails due to its being far cheaper to produce than GHIT and due to lack of meaningful industry regulation of quality, usability and safety.

7.  The lack of HIT regulation, post-market surveillance, formal validation and accountability is a special accommodation that is unprecedented in modern medicine.

8.  Underlying HITECH and "Meaningful use" is the assumption that all HIT is good HIT.

9.  A good or even average paper system is better for patients than a bad health IT system.

10.  The incentives and coercive aspects of HITECH would not be needed if GHIT prevailed.

11.  The coercive force of government should have been directed not at users, but at sellers, to produce GHIT and to abolish BHIT.

12.  The term "meaningful use" is political rhetoric whose criteria were decided by committee and industry influence; nobody knows if meeting the criteria will prove truly "meaningful" or not.  (That medical informaticists placidly accepted the term is a disgrace to a field that strives for terminological precision; "good faith use" would have been precise).

13.  Human research protections are given the blind eye with respect to commercial health IT.

14.  Health IT being used safely is currently by happenstance and via compensation for flaws by clinicians who improvise (which itself introduces risk and is stressful), not by design.

15.  Business IT a/k/a MIS personnel have far too narrow an education and experience to make pronouncements about health IT "transforming" medicine.

16.  IT personnel should be part of the medical team, including liability for IT-related failure.

17.  The commercial health IT sector is not an evidence-based domain.

18.  A cybernetic "Libby Zion" catastrophe is unavoidable, and probably the only way to "transform" the health IT industry into an evidence-based industry - essential before that industry can even begin to "transform" (i.e., facilitate improvement of) medicine.

Had Dr. Barnett's Ten Commandments not been disobeyed in favor of cybernetic idolatry, the Health IT Truisms in 2012 would appear far different.

-- SS

The Rise of the Corporate Physician, and the "Metastasis of Big Corporations"

Public discussion has raised more questions over the last few months about physicians taking care of patients as corporate employees. 

More Physician Practices Taken over by Large Corporations

This year, more stories have appeared about large corporations taking over physician practices.  In February, there was an account of efforts by competing nominally non-profit health insurance company Highmark and nominally non-profit hospital system UPMC in Pittsburgh in a "race to gobble up private physician practices," per the Pittsburgh Tribune-Review.  In March, the Washington Post featured a first-person account of what it is like for a physician in a private practice to try to hold out against the trend towards corporate practice.  In May, the Los Angeles Times noted how for-profit dialysis provider Da Vita purchased a large, but already for-profit operator of physician groups.  In October, Reuters reported how the recently announced acquisition by giant for-profit insurance company UnitedHealth of the biggest Brazilian for-profit managed care company will result in UnitedHealth owning an operating a Brazilian network of hospitals and clinics.

Concerns about Concentration of Market Power and Prices

In an increasingly financialized country, the media has featured concerns that the trend towards corporate physician practice might result in increasing market power for a few large corporations, and hence increased prices.  For example, in August, Anna Wilde Matthews reporting for the Wall Street Journal, noted

 Hospitals say the acquisitions will make health care more efficient. But the phenomenon, in some cases, also is having another effect: higher prices. 

As physicians are subsumed into hospital systems, they can get paid for services at the systems' rates, which are typically more generous than what insurers pay independent doctors. What's more, some services that physicians previously performed at independent facilities, such as imaging scans, may start to be billed as hospital outpatient procedures, sometimes more than doubling the cost.
 
The result is that the same service, even sometimes provided in the same location, can cost more once a practice signs on with a hospital.

Major health insurers say a growing number of rate increases are tied to physician-practice acquisitions. 

As Ms Matthews also reported for the Wall Street Journal, state regulators are beginning to worry about acquisitions of doctors' practices by hospital systems may drive up prices.

California's attorney general has launched a broad investigation into whether growing consolidation among hospitals and doctor groups is pushing up the price of medical care, reflecting increasing scrutiny by antitrust regulators of medical-provider deals.

Concerns about Care Quality

Concerns about whether physicians who must practice under the command of corporate executives will be able to put patient care ahead of corporate interests are also appearing, but not yet as prominently.

For example, Steve Twedt, writing for the Pittsburg Post-Gazette in September, looked into whether the multiple practice acquisitions by the area's two biggest ostensibly non-profit health care corporations might affect patient care.  He first noted "competition between Highmark and UPMC for doctors, and health care overhaul that is steering doctors into larger systems...."  Then he suggested that this has lead to marked discontinuities in patient care when physicians switch employment,

Out of the blue, people will learn their doctor has left a practice with little or no explanation, and without a forwarding address. When a physician effectively disappears, the cause usually is tied to the physician's employment contract, says a local health care attorney.

These cases of apparently vanishing physicians may be due to the contracting practices of physician employers, particularly large health care corporations.  The lawyer Mr Twedt interviewed explained,

most physician contracts now contain clauses that prohibit doctors from soliciting patients if they leave a practice.

While it's not always clear what constitutes 'solicitation,' it generally means departing physicians cannot contact their patients to invite or entice patients to follow them to their new location. They also cannot take their patient list with them, since that is property of the practice.

'I would imagine the doctor wouldn't contact them because he can't, or he doesn't have their address,' said Mr. Cassidy.

Contracts also often require that doctors cannot practice medicine within 10 miles of the previous practice office, and sometimes the required distance is even greater. Nor can they give out information about the practice they're leaving. Violating these contract terms could mean a financial penalty, such as loss of severance pay.

Finally, and most troubling, cardiologist blogger Dr Melissa Walton-Shirley recounted in some much more colorful language some consequences of cardiology practices which were acquired by large hospital systems.  She noted...

 

Referral Decisions Influenced by Management Edicts, but Maybe Not Patients' Needs

 

Physicians may be

sweating bullets over whether they are going to hit their benchmarks to retain their salaries. My anxious friends are now calling me for more referrals and more practice support.  They take any transfer I give them....

They may

 morph from human flesh into a Rubik's cube of relative value units (RVUs), the formula through which all future salaries and bonuses are calculated.

Resulting Loss of Continuity

Independent cardiologists opened office doors to find their patients who were anticipating decisions on timing of defibrillators, caths, or medical therapy had undergone testing at other facilities. Those tests were interpreted by cardiologists who were in no way connected to their care, their referrals to unfamiliar testing venues now incentivized by hidden contractual microformulas. They were evaluated far away from the familiar eye of their long-time cardiologists.

Summary

Back in the day, most physicians who took direct care of patients did so out of practices they or other physicians ran and owned.  The majority of physicians who took care of physicians as employees worked for the military or the Veterans Administration, or took care of patients only part-time as faculty of medical schools.  In a country increasingly prodded by market fundamentalism, the last few years has seen a major change in health care:  more and more physicians are taking care of patients as employees of large corporations, more often for-profit.

 I should add, though, that the recent push towards corporate practice was not just due to market fundamentalism, but also seems to in part be due to provisions of the recent attempt at US health care reform, the Affordable Care Act, which called for care by large organizations called accountable care organizations (ACOs).   However, like some other major changes in health care in the US over the last few years pushed by the increasing dominance of large corporations, this one happened without any rigorous assessments of whether the benefits for individual patients or public health would outweigh the harms, and justify the costs. 

Justified by the realization, now mostly forgotten, that health care is nothing like an ideal free market (look here), direct health care used to be almost entirely provided by health care professionals, often working in small, non-profit community hospital settings.  In fact, the American Medical Association used to condemn the corporate practice of medicine.  In addition, the corporate practice of medicine used to be illegal in many US states (look here).

We have changed all that, without too much thought, and without any rigorous assessment.  Now it seems increasingly likely that these changes are just increasing health care costs, and probably will cause worsening patient care and will worsen patients' and the public's health. 

As Dr Melissa Walton-Shirley wrote more vividly,

Monopolies never meant to be planted in gardens so small grew like bull thistles, literally overtaking all the good things that small community medicine had to offer. They are now barely recognizable small towns with the crabgrasslike metastasis of big corporations....

Will there be time to rethink this headlong rush before our health care options are restricted to that provided by one of a few huge corporations?  

True health care reform would reverse the trend to organize health care within ever larger, more bureaucratic, more monolithic, more dominant organizations.  Such reform is unlikely to happen until we see the nadir produced by the current bandwagon. 

New York Times: "The Ups and Downs of Electronic Medical Records"

The "downs" of health IT have rarely been presented in a prominent public forum.

After a recent Center for Public Integrity series and New York Times story on EHR-related upcoding, the New York times does so again.  This blog is cited:

October 8, 2012
The Ups and Downs of Electronic Medical Records
New York Times
By MILT FREUDENHEIM

The case for electronic medical records is compelling: They can make health care more efficient and less expensive, and improve the quality of care by making patients’ medical history easily accessible to all who treat them.

Small wonder that the idea has been promoted by the Obama administration, with strong bipartisan and industry support. The government has given $6.5 billion in incentives, and hospitals and doctors have spent billions more.

But as health care providers adopt electronic records, the challenges have proved daunting, with a potential for mix-ups and confusion that can be frustrating, costly and even dangerous. 

"Dangerous" is the concept that has been most lacking in public debate.  Through my many years of writing on health IT difficulties and more recently my legal work, I know of injuries and deaths caused or contributed to by bad health IT (e.g., see here and here).  I experienced a tragedy in my own family as well.

The New York Times has done a significant public service in mentioning this critical issue, long hushed by the hyper-enthusiasts to whom computers seem to hold more rights than people, and to whom plans for a "cybernetic healthcare utopia" override long held principles and standards for human subject research protections.

Some doctors complain that the electronic systems are clunky and time-consuming, designed more for bureaucrats than physicians. Last month, for example, the public health system in Contra Costa County in California slowed to a crawl under a new information-technology system. 

Doctors told county supervisors they were able to see only half as many patients as usual as they struggled with the unfamiliar screens and clicks. Nurses had similar concerns. At the county jail, they said, a mistaken order for a high dose of a dangerous heart medicine was caught just in time. 

That scenario, not at all unique (e.g., see New York Times, "Designed for Efficiency, New Computer Software at Health Dept. Misfires", Nov. 2010 and my comments here), is a warning that the technology needs significant work and cannot just be rammed into place.

The first national coordinator for health information technology, Dr. David J. Brailer, was appointed in 2004, by President George W. Bush. Dr. Brailer encouraged the beginnings of the switch from paper charts to computers. But in an interview last month, he said: “The current information tools are still difficult to set up. They are hard to use. They fit only parts of what doctors do, and not the rest.”

Refreshing candor that should be coming from the present ONC leader, not the two-generations-ago former incumbent.

Like all computerized systems, electronic records are vulnerable to crashes. Parts of the system at the University of Pittsburgh Medical Center were down recently for six hours over two days; the hospital had an alternate database that kept patients’ histories available until the problem was fixed. 

Those crashes are also not uncommon.  See for instance my posts on the common refrain when that happens that "patient care has not been compromised" (query link).

Even the internationally respected Mayo Clinic, which treats more than a million patients a year, has serious unresolved problems after working for years to get its three major electronic records systems to talk to one another. Dr. Dawn S. Milliner, the chief medical informatics officer at Mayo, said her people were “working actively on a number of fronts” to make the systems “interoperable” but acknowledged, “We have not solved that yet.”

Perhaps the worst example of that phenomenon is the DoD-VA interface debacle.  See my apparently popular (based on "hits") March 2010 post "VA / DoD EHR Interface Debacle: Will It Take the Luminosity Of A Dozen Supernovas To Shed Light On The Obvious About Healthcare IT?"

Still, Dr. Milliner added that even though there a lot of challenges, the benefits of information technology are “enormous” — improved safety and quality of care, convenience for patients and better outcomes in general.

Enormous?  It is quite clear that this has not been proven in the real world with large scale health IT, especially in its present form.  It may be the case that the improvements will be modest at best.  Many if not most healthcare problems may not be related to documentation at all (see my Dec. 2010 post "Is Healthcare IT a Solution to the Wrong Problem?" for instance).  Also, as I've written, a good or even fair paper record system is better for patients than BHIT (bad health IT).

In the rare event that a large-scale system goes down at Mayo, backup measures are ready, teams are called in to make rapid repairs, and if necessary “everyone is ready to go on paper,” Dr. Milliner said. 

Paper records do not unexpectedly "go down" en masse.

Reliable data about problems in the electronic systems is hard to come by, hidden by a virtual code of silence enforced by fears of lawsuits and bad publicity. A recent study commissioned by the government sketches the magnitude of the problem, calling for tools to report problems and to prevent them. 

"Omertà" is perhaps the best term of art for this form of silence...

Based on error rates in other industries, the report estimates that if and when electronic health records are fully adopted, they could be linked to at least 60,000 adverse events a year.

My own estimates are much higher if the technology and its industry are not first drastically reformed, as in my April 2010 post "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers."

The Obama administration will issue a report on patient safety issues in early November, the current national coordinator, Dr. Farzad Mostashari, said in an interview. That report was requested last year by a panel on health I.T. safety at the Institute of Medicine, a unit of the National Academies of Science.

Considering the available data is limited, as per the FDA and IOM itself (see addendum here), the report should be immediately suspect for underestimation/cheerleading if not whitewashing.

... Elisabeth Belmont, a lawyer for the MaineHealth system, based in Portland, advises hospitals to reject contract language that could leave them responsible for settling claims for patient injuries caused by software problems.

The IT industry is quite mature and no longer merits such special accommodation.  As in other industries, liability should be covered by the industry itself, not by customers (and patient victims).  See "No More Soft Landings for Software: Liability for Defects in an Industry That Has Come of Age", Frances E. Zollers, Andrew McMullin, Sandra N. Hurd, and Peter Shears, Santa Clara Computer & High Technology Law Journal, May 2005.

The institute also recommended that software manufacturers be required to report deaths, serious injuries or unsafe conditions related to information technology. So far, however, neither a new safety agency nor such a reporting system has been adopted.  Some of the largest software companies have opposed any mandatory reporting requirement.

Post market surveillance is standard for other medical device sectors and the pharma industry, as well as other mission critical IT sectors.  The continuing, remarkable special accommodation for health IT is unearned, unjustified and ethically inexplicable.

Critics are deeply skeptical that electronic records are ready for prime time. “The technology is being pushed, with no good scientific basis,” said Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog Health Care Renewal. He says testing these systems on patients without their consent “raises ethical questions.” 

In other words, while I am an advocate for good health IT, the technology is not yet ready to be pushed nationally.  Bad health IT prevails.  From my Medical Informatics teaching site:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

(I would replace the term "critic" with "realist" and/or "patient rights advocate.")

Another critic, Dr. Scott A. Monteith [who has guest-posted at this blog - ed.], a psychiatrist and health I.T. consultant in Michigan, notes that Medicare and insurance companies generally do not pay for experimental treatments that have not proved their effectiveness ... Dr. Monteith said the electronic systems were “disrupting traditional medical records and, beyond that, how we think” — the process of arriving at a diagnosis. For example, the diagnosing process can include “looking at six pieces of paper,” he said. “We cannot do that on a monitor. It really affects how we think.”

The systems are disruptive due to the paradigm changes, made far worse by their also often being mission hostile in design.

“The problem is each patient is an individual,” said Ms. Burger, who is president of the California Nurses Association. “We need the ability to change that care plan, based on age and sex and other factors.” She acknowledged that the system had one advantage: overcoming the ancient problem of bad handwriting. “It makes it easier for me to read progress notes that physicians have written, and vice versa,” she said.

While this is true, it is also true that the loss of context and structure produces legible gibberish that does not relate the patient narrative well.  Also, the same legibility improvement could be obtained via word processors - or typewriters - that cost far less than the tens of millions of dollars or more per organization that clinical IT commonly costs.

Some experts said they were hopeful that the initial problems with electronic records would be settled over time.

I'm one of them.  Without major health IT industry reforms, however, including strict adherence to evidence-based practices (as that selfsame industry sector demands of medicine and ironically and hypocritically claims its products will enable), I don't expect to see the problems settled in my lifetime.

Dr. Brailer, who now heads Health Evolution Partners, a venture capital firm in San Francisco, said that “most of the clunky first-generation tools” would be replaced in 10 years. “As the industry continues to grind forward, costs will go down,” he said. 

One should ask - why are 'first generation' tools still in abundance, decades into the healthcare information technology industry?  Further, as the industry "grinds forward" without oversight and patient protections, people will be injured.

Mark V. Pauly, professor of health care management at the Wharton School, said the health I.T. industry was moving in the right direction but that it had a long way to go before it would save real money.  “Like so many other things in health care,” Dr. Pauly said, “the amount of accomplishment is well short of the amount of cheerleading.”

That is an understatement.

(Not covered in this article perhaps due to limited space are the issues of information security, privacy and confidentiality that are compromised by current clinical IT.)

In conclusion, it is good that the New York Times has brought the downsides into the public eye.  While the technology's not "ready for prime time", a story like this is ready for prime time, and is in fact long overdue:

-- SS

Healthcare IT Transparency Could Stand Some Improvement

Transparency in the health IT sector is akin to the transparency of Pb (lead).

The following report comes from the FDA Maude (Manufacturer and User Facility Device Experience) voluntary-reporting database, reported by a (likely unhappy) biomedical engineer a month after the "incident" - the nature of which is deliberately kept hidden.  This is regarding the PICIS "Pulsecheck" EHR for emergency departments:

Report Date     05/14/2010

PICIS INC. CARESUITE ED PULSECHECK S/W, TRANSMISSION & STORAGE PATIENT DATA
Event Type:  Other
Patient Outcome:  Required Intervention

Event Description

The customer has reported a patient incident that has prompted a review of their internal process and possible issues surrounding the incident. The customer report alleges the involvement of picis' ed (emergency dept. ) electronic health record application, whereby, duplicate results were received by the picis ehr application from an enterprise info system, which, when displayed in their entirety may have contributed to some degree of confusion for the treating physician - the context of which the customer has declined to clarify any further.  [What in the world? -ed.] At this time, we have been informed by the customer that they are restricted by senior leadership from disclosing any specific details regarding the patient's status, the specific type of result or evidence of application performance to support picis' investigation.

"Restricted by senior leadership from disclosing any specific details regarding the patient's status, the specific type of result or evidence of application performance to support Picis' investigation?"

That is perverse on its face, and probably in violation of Joint Commission safety standards on reporting of incidents that could affect other organizations.

Manufacturer Narrative

Picis' investigation into the reported incident is based on a limited exchange of info with the customer, as well as our internal review of the application design and current configuration in use at the reporting site. Review of configuration files, existing system build at the client site, interface specification documents and previous customer communications demonstrate that the customer implemented and accepted the picis edis in 2008. During this process, the picis edis system was configured to display all results sent from the customer's enterprise system rather than configuring the results display in 'overwrite' mode. Prior to acceptance, an investigation by picis and the client revealed that it was the sending system, sending multiple duplicate results messages [great quality - ed.] and a request was made by the customer of that enterprise vendor [I can only wonder who that was - ed.] to investigate. However, due to the enterprise system's protocol for 'add on' tests, it was not possible to utilize the 'overwrite' configuration due to the risk of filtering out unique results and subsequently not presenting the clinicians with important info. Therefore, the customer elected to have all results displayed.

A workaround that apparently, from the limited information provided, led to physician confusion..."the context of which the customer had", not very helpfully, "declined to clarify any further."

Hospitals also are required to have add'l safeguards in place for the handling of critical results including expedited reporting of critical results with a licensed responsible caregiver rather than relying solely on standard results reporting processes (joint commission national patient safety goal 02. 03. 01).

This is not a resounding statement of confidence in health IT...

The customer is currently working with a 3rd party integration consultant to improve the handling of results sent to picis' electronic health record application. We are providing support as it is requested. At this time, no corrective action is needed. 

The "senior leadership" that withheld details was protecting what, exactly?  Money and contracts, perhaps; conflicts of interest, possibly ... but not patients.

All I can say is:

Imagine if this was a report on a new drug suspected of harming people. 

What in heaven's name was going on here?

As I've written many times, and as illustrated by this MAUDE report, the health IT industry must first be transformed into one of evidence-driven IT practices and transparency before anyone touting its products has any business even speaking about the technology "transforming medicine."

-- SS

Good HIT, Bad HIT, HIMSS And Reckless Technology Advocacy: Will This Hurt President Obama?

HIMSS, the Health Information Systems Management Society, is the large vendor trade group representing healthcare IT sellers.

At the HIMSS blog entitled "Health IT is an essential element to transform the Nation’s healthcare system" (link), Carla M Smith, MA, CNM, FHIMSS writes this with regard to the House  letter to HHS Secretary Sebelius asking her to suspend payments for the EHR Incentive Payments authorized in the American Recovery & Reinvestment Act of 2009:

HIMSS opposes halting the Meaningful Use EHR Incentive Program. Health IT is an essential, foundational element of any meaningful transformation of the Nation’s healthcare delivery system. 

(Of course, not mentioned is "transformed" into what, exactly; this utopian ideation is a topic for another time.)

A chart is then presented as to "how US civilian hospitals have, since the first incentive payments were made in second quarter, 2011, matured in their use of health IT."  Then this statement is made:

Healthcare providers are adopting certified EHRs and using them for meaningful purposes; thus, achieving Congressional intent to improve the quality, safety, and cost-effectiveness of care in U.S.

Really?  (See my Feb. 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified.")

This non-evidence based, amoral advocacy by HIMSS for health IT may cost the President the November election.  HIMSS has beguiled the president into similar unquestioning advocacy for the technology in its present form, which his opponents are now (rightfully) seizing upon as in the House letter.

The reckless mistakes made by HIMSS and their advocates include these two:

1.   The unquestioned belief that this expensive technology would save billions of dollars in healthcare costs, instead of depleting precious healthcare resources better spent on, say, improvement of healthcare services for the poor.

2.  More importantly, the appallingly naïve belief that any health IT is good health IT, and that any health IT is only capable of good, not bad.

HIMSS has thus failed to recognize - or perhaps worse, recognized but recklessly ignored - the profound difference between good health IT (GHIT) and bad health IT (BHIT).

As I defined at my teaching site on Medical Informatics:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  

I am an advocate of the former, and an opponent of the latter.

Bad health IT is prevalent in 2012 due to lack of meaningful quality control, software validation, usability standards and testing, and regulation of any type - a situation HIMSS long favored.   (The failed National Programme for HIT [NPfIT] in the NHS learned this the hard way, as will Australians needing emergency care, I predict.)

Put bluntly, in the end BHIT maims and kills patients, squanders precious healthcare resources, and drains the treasury into IT industry pockets (see my Oct. 3, 2012 post "Honesty and Good Sense on Electronic Medical Records From Down Under" and this query link on health IT risks). 

Further, the failure to recognize that the technology's downsides need to be understood and remediated before national deployment occurs and under controlled conditions, not after (which uses patients as non-consenting experimental subjects for software debugging), speaks to gross corporate negligence on the part of HIMSS.  It's not as if they did not have advance warning of all of healthcare IT's deficiencies. 

BHIT also permits record alterations after the fact that may be to conceal medical error.  I am aware of numerous instances of such alterations, fortunately caught by critical-thinking, detail-minded attorneys.  However, like health IT harms, the incidences of known alteration attempts likely reflect the "tip of the iceberg."

HIMSS and its fellow travelers have thus led this administration down the Garden Path of health IT perdition.

I warned of this in a Feb. 18, 2009 Wall Street Journal letter to the editor:

Dear Wall Street Journal:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors. [That project, the NPfIT in the NHS, has now been abandoned - ed.]

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

Scot Silverstein, MD

Mr. President, again, quite bluntly, the health IT industry took you for a ride, and the damage is done and is continuing due to lack of any meaningful health IT post market surveillance.   (As I wrote here, the untoward results have already been used against the current administration, with more perhaps to follow.)

In the U.S. we have the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) in place:

The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form.  See Elixir Sulfanilamide disaster. It replaced the earlier Pure Food and Drug Act of 1906.

It should be honored, not ignored via special accommodation to the health IT industry and its trade group.

HITECH also needs to be put in dormancy until the problems with these unregulated medical devices get worked out in relatively small, controlled settings to minimize risk, with patient informed consent.  This is in accord with human rights documents dating at least to the Nuremberg Code, as in any new, experimental or partly-experimental medical device, pharmaceutical, or therapy.

-- SS
 

Don't Cry for Me, Brazil - UnitedHealth May Buy Brazilian Managed Care Company

While Health Care Renewal's bloggers are at the moment all Americans, and hence tend to focus on the wild and crazy US health care system, we have suggested that many of the issues we discuss have global implications.  In fact, the first article I managed to publish on health care dysfunction was in a European journal, and framed the US experience as a cautionary tale for other countries. [Poses MD. A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14: 123-130.  Link here.]

The Possible Acquisition by UnitedHealth of Brazil's Leading Managed Care Company

However, sometimes it appears that the US experience might be directly exported.  Today Bloomberg reported,

UnitedHealth Group Inc., the biggest U.S. health insurance company, is in talks to buy a stake or all of the Brazilian insurer and hospital operator Amil Participacoes SA, according to people familiar with the matter.

Acquiring all or part of Brazil’s biggest managed-care company, which carries a market value of 9.01 billion reais ($4.47 billion), would give Minnetonka, Minnesota-based UnitedHealth access to a growing private-insurance market in the world’s second-biggest emerging economy. It also may generate more opportunities for UnitedHealth’s Optum unit, which provides technology and consulting to health systems in India, China, the U.K. and elsewhere.

UnitedHealth's Ethical Record

UnitedHealth would be the company whose CEO once was worth over a billion dollars due to back dated stock options, some of which he had to give back, but despite all the resulting legal actions, was still the ninth best paid CEO in the US for the first decade of the 21st century (look here). UnitedHealth would be the company whose current CEO made a cool $106 million in 2009 (look here).

Moreover, UnitedHealth would also be the company known for a string of ethical lapses:
- as reported by the Hartford Courant, "UnitedHealth Group Inc., the largest U.S. health insurer, will refund $50 million to small businesses that New York state officials said were overcharged in 2006."
- UnitedHalth promised its investors it would continue to raise premiums, even if that priced increasing numbers of people out of its policies (see post here);
- UnitedHealth's acquisition of Pacificare in California allegedly lead to a "meltdown" of its claims paying mechanisms (see post here);
- UnitedHealth's acquisition of Sierra Health Services allegedly gave it a monopoly in Utah, while the company allegedly was transferring much of its revenue out of the state of Rhode Island, rather than using it to pay claims (see post here)
- UnitedHealth frequently violated Nebraska insurance laws (see post here);
- UnitedHealth settled charges that its Ingenix subsidiaries manipulation of data lead to underpaying patients who received out-of-network care (see post here).
- UnitedHealth was accused of hiding the fact that the physicians it is now employing through its Optum subsidiary in fact work for a for-profit company, not directly for their patients (see post here).

Exporting Health Care Dysfunction

So while the deal discussed above might be good for UnitedHealth, it is not so clear that it would be good for Brazil, as it would give a big toe-hold in Brazil to a US company whose actions have not always been exemplary, and hence may give Brazil a whiff of US health care dysfunction.


Health care dysfunction in the US has been manifested by continuously rising costs while access and quality have been threatened.  While it is possible that our recent Affordable Care Act reforms will improve access, and perhaps quality, it is likely the country will continue to lag other developed countries in providing health care value (for examples, look at this Commonwealth Fund site including international comparisons.) 

Moreover, health care dysfunction may have resulted in a uniquely distressed physician population in the US compared to those in other countries.  Here we discussed a recent large-scale survey showing nearly half of all US physicians, and more than half of generalist physicians are burned-out.  Here we discussed another recent large-scale survey showing that more than a third of US academic physicians want to quit their institution and/or academia. That survey may have suggested that their dissatisfaction was due to concerns that their leaders did not share their values about patient care and academics, their leaders may put revenue ahead of these values, their leaders may have suppressed dissent, free speech, academic freedom, and whistle-blowing, and their leaders may have acquiesced to a culture of dishonesty and deceit.

 On Health Care Renewal, we have postulated that our unique mix of health care misery may be due to a witch's brew of  concentration and abuse of power in health care, bad (that is, ill-informed, incompetent, mission-hostile, self-interested, conflicted or corrupt) leadership of health care, tactics used by bad health care leadership such as use of perverse incentives, creation of conflicts of interest, deception, disinformation, propaganda, intimidation, etc

Thus we would not recommend that other countries look to our health care system as a role model, and that their citizens should be very skeptical of US health care organizations, particularly large, for-profit health care corporations with spotty ethical records, when they come calling. Meanwhile, we in the US must do a better job solving our own health care problems, and should avoid trying to export them.

House Ways And Means, and Energy and Commerce, Note EHRs Not What They Were Made Out To Be, Calls For HITECH Moratorium

I have called numerous times for a moratorium on ambitious national health IT programs.  See 2008 and 2009 posts here and here for example.  My calls are due to the prevalence of bad health IT (BHIT) in 2012, hopelessly deficient if not deranged talent management practices (especially when compared to clinical medicine) in the health IT industry, and complete lack of regulation, validation and quality control of these potentially harmful medical devices. 

I also called the HITECH stimulus act in its present form social policy malpractice.  (See my Sept. 2012 post "At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professional".)

Congress is starting to catch on:

Letter from House Ways and Means, and Energy & Commerce, to Secretary Sebelius of HHS.  Click here to download.

The letter to HHS secretary Sebelius is from Congressmen Dave Camp (Chairman, Ways and Means), Wally Herger (Chariman, Ways and Means Subcommittee on Health), Fred Upton (Chairman, Energy and Commerce) and Joe Pitts (Chairman, Energy and Commerce Subcommittee on Health).

In the letter the following is noted:

Dear Secretary Sebelius:

We are writing to express serious concerns about the final Electronic Health Record (EHR) Stage 2 Meaningful Use rules recently issued by HHS and ONC.  We believe the Stage 2 rules are, in some respects, weaker than the proposed Stage 1 regulation released in 2009.  The results will be a less efficient system that squanders taxpayer dollars and does little, if anything, to improve outcomes for Medicare.

The letter then notes that the "Stage 2 rules ask less of providers and do less for program efficiency" and that the Stage 2 rules fail to achieve comprehensive interoperability in the face of
warnings that:

..".failure to set a date for certain interoperable standards would put as much as $35 billion in Medicare and taxpayer funds in the hands of providrrs who purchase and use EHR systems that are not interoperable."

They note the Stage 2 rules fail to achieve interoperability in a timely manner and that "more than four and a half years and two final MU rules later, it is safe to say that we are no closer to interoperability in spite of the nearly $10 billion spent."

A major reason for this, I believe, is regulatory capture by the IT industry as I outlined in my somewhat rhetorically-entitled posts "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" and "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?"

The House letter also notes:

It is highly counterproductive for providers to have purchased EHR systems that "cannot talk with one another" and cannot perform basic functions because of the insufficient standards set by your agency.

One of the critical "basic functions" is the note search capability upon which the vendors used their influence during the "public comments" period to have written out of existence, as in the above posts.  The influence became apparent due to serious public comment editing mistakes by customers.  One wonders what other episodes of vendor influence did not make it into the public spotlight.

The house committee members also note:

Perhaps not surprisingly, your EHR inventive program appears to be doing more harm than good.  A recent analysis of Medicare data by the New York Times explains the costly consequences.

Unfortunately, the letter did not spotlight the excellent analysis done by the Center for Public Integrity and published before the NYT article ("Cracking the Codes" by Fred Schulte et al.)

Finally, the letter calls for HHS to:

... Immediately suspend the distribution of incentive payments until your agency promulgates universal interoperable standards.  Such a move would also require a commensurate delay of penalties for providers who choose not to integrate HIT into their practice"  and to "significantly increase what's expected of Meaningful Users."

It is unfortunate the letter seems to make the assumption that health IT in its present form, and the industry in its present state of anarchy, can produce good health IT (GHIT) that is safe and effective.  (As I've written, we need ease-of-use, reliability and safety - basic "operability" - before interoperability.)  Perhaps the congresspeople need to read my recent post "Honesty and Good Sense on Electronic Medical Records From Down Under".

Financial issues are one major concern, but patient harm and death due to the disruptive influences of BHIT are, in fact in many respects more important.

Finally, to those who would suggest a political angle to this letter (I note comments on sites such as on the Histalk blog that the authors are Republicans), I note that ONC was started in 2004 by George W. Bush, and that health IT has always had broad bi-partisan support.

Reality in healthcare is more often than not apolitical, and injured and dead patients really don't care much about ideology.

-- SS

Health Care Academics' Unrest and Bad Health Care Leadership?

Last month we discussed a recent, large scale study of physician burnout, and wondered whether it would finally inspire some discourse about why physicians are really so upset.  In particular, we hypothesized,  based on some real, if limited data, that physician angst, dissatisfaction, burnout, etc may mainly be a response to the problems with leadership and governance of health care organization we post about on Health Care Renewal.

After that post, one of our scouts found a very interesting and relevant article from earlier this year which got little attention at the time, but deserves more.  [Pololi LH, Krupat E, Civian JT, Ash AS, Brennan RT. Why are a quarter of faculty considering leaving academic medicine? A study of their perceptions of institutional culture and intentions to leave at 26 representative U.S. medical schools. Acad Med. 2012; 87: 859-69. Link here.]

Study Design

This was a cross-sectional survey of faculty at 26 medical schools in the US, selected to be similar to the general population of medical schools in the country.  At each school, 150 faculty were randomly chosen stratified by sex and age, and then the sample was enriched to include additional minority faculty and women surgeons, for a total of 4578.

The faculty were sent a multi item survey to assess their perception of the organizational culture of their institutions, and asked about their intentions to continue in or leave their current positions and academic medicine.  Responses to each survey item were allowed to be from 1 = strongly disagree, to 5 = strongly agree.  The items on the survey were combined into various scales.  A number of items on the survey seemed to be related to issues we frequently discuss on Health Care Renewal.  These items ended up in three different scales, entitled Relatedness/Inclusion, Values Alignment, and Ethical/Moral Distress.  The survey items are listed below, grouped by issue, with the scales into which they were combined noted.

Issue: Mission-Hostile Leadership

Administration only interested in me for revenue   (Reverse coded) (Values Alignment)
Institution committed to serving the public (VA)
Institution's actions well-aligned with stated values and mission (VA)
Institution puts own needs ahead of educational/clinical missions (RC) (VA)
My values well-aligned with school's (VA)
Institution awards excellence in clinical care (VA)
Institution does not value teaching (RC) (VA)
Have to compromise values to work here (Ethical/Moral Distress)

Issue: Deceptive, Unethical Leadership

Felt pressure to behave unethically (Ethical/Moral Distress)
Need to be deceitful in order to succeed (EMD)
Others have taken credit for my work (EMD)

Issue: Generation of the Anechoic Effect by  Suppression of Free Speech, Academic Freedom, Dissent, Whistle-Blowing,

Feel ignored/ invisible (RC) (Relatedness/Inclusion)
Hide what I think and feel (RC) (R/I)
Reluctant to express opinion/ fear negative consequences (RC) (R/I)

So in summary, the survey contained quite a few questions about mission-hostile management, comprising nearly all of the Values Alignment scale, some questions about deceptive or unethical leadership, all in the Ethical/Moral Distress scale, and some about generation of the anechoic effect by suppression of free speech, academic freedom, dissent, and whistle-blowing, all in the Relatedness/Inclusion scale.

Results

The response rate was 52% (N=2381.)

Unfortunately, the article did not include the distributions of the responses to individual survey items, and only included the mean and standard error of the scale scores.  The values for the scales of most interest were:
Relatedness/Inclusion  3.56 SE= 0.022
Values Alignment  3.25 SE=0.028
Ethical/Moral Distress 2.36 SE=0.022

Note that the article did not address the degree individual items, especially those listed above, contributed to variation in the scale scores.


A small majority of faculty indicated their intentions to stay at their institutions (57%).  Of the remainder, 14% were considering leaving their school due to dissatisfaction, and another 21% were considering leaving academic medicine due to dissatisfaction.  The remainder were considering leaving due to personal/ family reasons or to retire.

The authors did complex multinomial logit modeling to assess the relationships among the various scales, demographic factors, and intention to leave.  Most relevant to us, Relatedness/Inclusion was significantly related to intention to leave the institution due to dissatisfaction (Coefficient -0.69, p lt 0.001, OR =0.50), as was Values Alignment (-0.39, p=0.04, OR=0.68), but not Ethical/ Moral Distress.  Furthermore, Relatedness/Inclusion was related to intention to leave academic medicine due to dissatisfaction (-0.48, p lt 0.001, 0.62), as was Ethical/Moral Distress (0.60, p lt 0.001, OR =1.82). The article did not address whether individual survey items, including those of most interest listed above, were related to intention to leave.  The article also did not address whether responses to the survey or intention to leave varied across faculty characteristics, medical school characteristics, or individual medical schools. 

Summary and Comments

This very large survey of faculty from multiple US medical schools showed that more than one-third were considering leaving their institutions or academic medicine due to dissatisfaction, indicating a striking prevalence of faculty distress.  Their responses to questions about perceived organizational cultural and leadership problems, including those possibly related to leadership's perceived hostility to the mission, leadership's perceived dishonesty or unethical behavior, and leadership's suppression of dissent, free speech, academic freedom, and whistle-blowing were related to their intentions to leave due to dissatisfaction.

These results suggest the hypothesis that much of faculty angst may be due to the sorts of problems with leadership and hence organizational culture that we discuss on Health Care Renewal.  Since this was a cross-sectional survey, it certainly does not offer scientific proof of this hypothesis.  Note that there is other evidence from numerous cases discussed in Health Care Renewal, qualitative studies and our much smaller study published only in abstract form that also supports this hypothesis (look here). 

One part of the author's discussion of their findings was particularly relevant:

Our findings are congruent with metaanalyses of 25 years of organizational justice research outside medicine. These studies suggest that employee perceptions of organizational justice and an ethical climate are related to increased job satisfaction, trust in leadership, enhanced performance, commitment to one’s employer, and reduced turnover.

 The scale of ethical/moral distress (see Table 1) reflects reactions to the prevailing norms and possible erosion of professionalism and increased organizational self-interest. There is a growing belief that organizations influence and are responsible for the ethical or unethical behaviors of their employees.To our knowledge, faculty perceptions of 'moral atmosphere' and 'just community' embedded in our survey have not been previously investigated in academic medicine, even though the ethical concepts of professionalism and justice can be used to guide the pursuit of excellence in the missions of medical schools. Several scholars have called for academic medicine to attend to its social justice and moral mission. Faculty perceptions
of organizational justice are pivotal to the critical issue of professionalism in medicine. The ethical/moral distress scale in the survey reported here included items such as 'the culture of my institution discourages altruism' and 'I find working here to be dehumanizing.' (See Table 1 for other items in this scale.) In that ethical/moral distress was more strongly related to intent to leave academic medicine entirely than intent to leave one’s own institution, these negative feelings among faculty must be particularly disheartening to them and may color major career decisions.

I believe that the study by Pololi et al adds to the evidence that physician distress is a symptom of a dysfunctional system in which major health care organizations have been taken over by leaders more devoted to self-interest and short-term revenue than the values prized by health care professionals and academics.  This applies obviously to academic medical institutions, but also to other organizations that might have been expected to defend such professional and academic values, such as professional associations, accrediting organizations, and health care foundations.  As we said before, if physicians really want to address what is making them burned out and dissatisfied, they will have to regain control of their own societies, organizations, and academic institutions, and ensure that these organizations put core values, not revenue generation and providing  cushy compensation to their executives, first.  

Allegheny Health System Computer Crash (Again) and Paper Backups

I reported on a health IT crash in my May 2011 post "Twelve Hour Health IT Glitch at Allegheny General Hospital - But Patients Unaffected, Of Course..."

Now, there's this at the same healthcare system:

Computer system at West Penn Allegheny restored after crash 
Liz Navratil
Pittsburgh Post-Gazette
October 2, 2012

The computer system at West Penn Allegheny Health System crashed about noon today, temporarily leaving doctors and nurses to work off of paper records instead.

Kelly Sorice, vice president of public relations for the health system, said all systems have since been restored. She said the servers crashed about noon today when the system experienced a power surge.

Doctors in the health system keep paper copies of almost all of their records so they can reference them during power outages or scheduled maintenance times, Ms. Sorice said.

Some systems were up eight hours later and others were expected to come online overnight, according to a report at HisTalk.

Assuming the statement about "doctors keep paper copies of almost all their records" was not spin control regarding skeletal paper records, a question arises.

Why, exactly, spend hundreds of millions of dollars on computing if paper records are kept, and are perfectly sufficient to accomplish the following, the usual refrain in health IT crash scenarios?

Ms. Sorice said she did not know of any procedures that had been rescheduled and added that, "Patient care has not been compromised."

As a physician/ham radio enthusiast who did an elective in Biomedical Engineering in medical school, I also want to know:

1)  What caused the “power surge?”
2)  Why were the systems not protected against a “power surge?”
3)  Exactly how did the “power surge” affect the IT?

Note: I've created a new, searchable indexing term for HIT outage stories with the usual refrain along the lines that "patient care has not been compromised." 

See this query link using the new indexing term.

-- SS

Addendum Oct. 3:

Australian EHR reseacher and professor Dr. Jon Patrick opines:

Even if [the paper records are] skeletal they suggest an endemic lack of confidence. I think the hospital spokesperson hasn't seen the implication of their statement.

-- SS

Honesty and Good Sense on Electronic Medical Records From Down Under

Australians seem to not be as seduced by the Siren Song of cybernetic miracles as health IT leaders in the United States.

It took an Australian computer scientist at U. Sydney to dissect and perform a detailed analysis of the internals of an American EHR system, the results of which were disturbing to say the least.  This was a task the American members of the American Medical Informatics Association (AMIA) should have taken on.  It's not as if they're unaware of clinical IT problems.

It also seems to take a group of Australian researchers at the Univ. of New South Wales, the Australian Patient Safety Foundation, and the University of South Australia to perform a forensic analysis on U.S. data in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database, instead of Americans themselves. 

At least AMIA allowed the Australians the opportunuty to present their findings.

In "Patient Safety Problems Associated with Heathcare Information Technology: an Analysis of Adverse Events Reported to the US Food and Drug Administration" (free fulltext at this link), AMIA Annual Symposium Proceedings 2011;2011:853-7 the Australian researchers including Medical Informaticist and critical thinker Dr. Enrico Coiera (see here) analyzed healthcare information technology (HIT) events associated with patient harm submitted to the MAUDE database:

We downloaded all 899,768 reports that were submitted to MAUDE from January 2008 to July 2010 and searched for events using a broad definition of HIT as “hardware or software that is used to electronically create, maintain, analyse, store, receive, or otherwise aid in the diagnosis, cure, mitigation, treatment, or prevention of disease, and that is not an integral part of (1) an implantable device or (2) medical equipment.” We retrieved and classified 678 reports describing 436 unique events using a previously published methodology. Of the 436 HIT-related events that we examined, 11% (n=46) were associated with patient harm [this excludes the "near misses" - ed.] ... In this paper we specifically focus on examining the 46 events where HIT problems were associated with patient harm.

These submissions are voluntary, and due to systematic, severe impediments to submissions as below, this data likely represents a very small fraction ("tip of the iceberg" per FDA itself, link) of the true incidence of these events.  See the addendum to this post "Systematic impediments to voluntary reporting of health IT risks."

Summarizing the Australian researchers' findings (read the entire paper at the link above):

Medication problems represented 41% of the events of these types:

• Wrong patient
• Wrong dose or overdose
• Missed and delayed doses

Clinical process problems represented 33% of the events:

• Use errors in entering information ("use error" is an error due to poor and confusing design, as opposed to "user errors")
• Poor functionality of CPOE and PACS

Exposure to radiation occurred in 15% of the events

Surgery problems occurred in 11% of the events.

The authors recommended that "strategies to improve the safety of HIT should focus on designing safe user interfaces, integrated checks of key identifiers and decision support, and engineering safer clinical processes."

Unfortunately, that does not appear to be occurring in the U.S. to any significant degree.  "Certification" of health IT to meet government criteria for financial incentives is unrelated to such measures and is in my view symptomatic of industry regulatory capture (see here and here).  The IOM itself has instituted a "watch and wait" policy, a likely unique special accommodation in current regulation of medical devices (see here).

I reiterate this MAUDE data is voluntary and the impediments to its reporting systematic and severe.  See addendum to this post.

In the category of good sense on electronic medical records, I note the following articles:

Victoria aims for more open ICT strategy 

Pulse+IT Magazine
Kate McDonald
02 October 2012

The newly formed Victorian Information and Communications Technology Advisory Committee (VITAC) has released a draft strategy (PDF) describing how the state government should manage and use ICT to better provide government services.

The strategy recommends that the government engage more closely with the ICT sector and move away from customised products in favour of existing market offerings.

... It recommends that the government engage with the ICT market early in the procurement lifecycle. “We will avoid being locked into single suppliers by favouring open standards and will be open to any qualified ICT provider regardless of size. Procurement of ICT services will be made more efficient.”

The strategy should also provide guidance to agencies to move away from customised major ICT developments and use existing market offerings with little or no customisation instead.

What this means is abandoning the approach of large, single-source (monolithic), proprietary clinical information systems from large health IT vendors that try to cover everything, in favor of smaller, open standards-based "best-of-breed" applications (from vendors of all sizes) that can be woven together to meet users' needs:

The subsequent fallout from the Ombudsman's report led to the Victorian government cancelling several programs, including the $323 million HealthSMART program, an ambitious project to roll out common eHealth infrastructure throughout Victoria's public health services.

This included implementing iSOFT's (now CSC) i.PM patient administration system and Cerner's clinical information system in its hospitals, as well as InterSystems' TrakCare platform for community health agencies.

I note that another article in eHealth Insider mentions the same strategy in the UK, "Winchester switches off Cerner in ED":

The Royal Hampshire County Hospital in Winchester has switched off Cerner Millennium in A&E and moved to Patient First.  The electronic patient record system will also be switched off for theatres and order communications at the old Winchester and Eastleigh Healthcare NHS Trust ... Basingstoke and North Hampshire was pursuing an alternative IT strategy, built around a 'best of breed' approach to building on its existing systems.

The U.S. has yet to learn these lessons, and will likely repeat the same mistakes at the cost of hundreds of billions of dollars.

Unfortunately, I have no answers.  I see no way to avoid it, considering the HITECH momentum that favors the large-vendor monolithic product model.

-- SS

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

Addendum.  Systematic impediments to voluntary reporting of health IT risks:

From the 2010 FDA internal memo on health IT risks:

Limitations of the MAUDE search and final subset of MDRs include the following:

1.  Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including:

... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.

2.  Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.

3.  Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.

4.  Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.

5.  The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.

From the 2012 IOM report on health IT safety:

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

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

… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.

More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”

Not knowing the magnitude of the risks is an effect of the impediments, and does not represent a good environment for national implementation in my view.

I also add "fear of medical malpractice litigation" to the lists above.

-- SS

Traits that "Define a Great Hospital CFO" - Honesty, Integrity, Accountability not Included

A recent article in Becker's Hospital Review entitled, "6 Traits That Define a Great Hospital CFO" [Chief Financial Officer] was most remarkable for what traits were not included.

The Six Traits

Based on interviews with a managing director of health care recruiting for a large executive search firm, and an experienced CFO of large hospital system, the included traits were:
- "Conviction," including "some type of conviction and confidence that their decision-making abilities will lead the hospital to great healthcare outcomes, a healthy population and — as a result — a more financially stable organization."
- "Nimbleness and flexibility"
- "Calm demeanor"
- "Willingness to understand the clinical aspects," in particular, the ability to "at least understand the [clinical] processes from a layperson's point of view, and the most effective CFOs have great working relationships with physicians, nurses, technicians and others."
- "Ability to think long term"
- "Sense of humor"

To be fair, I am glad to see expectations that hospital leaders, even chief financial officers, know something about clinical care, and that they have some sort of commitment to it. This seems to be in contrast to our frequent posts about how the leadership of health care organizations often seems ignorant and uncaring about the health care context and health care values. (However, the phrase above about conviction was not clearly worded. In particular, it did not explicitly suggest quality clinical care ought to be a higher priority than revenue, and could have been read to mean that good care is just a means to increase revenue.)

I am also glad that the article promoted long-term thinking. It also seems to contrast with concerns (e.g., here) about how health care leadership may put short-term revenue ahead of all other goals, also called "financialization." However, again, the article did not explicitly give long-term goals a higher priority than short-term ones.

What was Missing

However, what was more striking were the dogs that did not bark. In particular, transparency, honesty and integrity or even being law-abiding were not on the list of key traits for a CFO. This is particularly noteworthy given how often we have discussed bad behavior by large health care organizations, including various kinds of deception and dishonest behavior, as well as outright crime, such as fraud, bribery or kickbacks, etc.

Also, the list of important traits did not include responsibility or accountability.   This is also noteworthy given that rarely if ever have the leaders of these organizations taken any responsibility or paid any penalty for bad behavior occurring on their watches. Although may large health care organizations have made numerous legal settlements of accusations that include fraud, kickbacks, etc, the leadership almost never admitted wrongdoing in any of them, and almost never had to accept any financial penalty form the organization. This parallels how the US legal system has rarely sought to punish any leader of a large health care organization in such cases, suggesting that health care leaders now have developed impunity.

Given that the article appeared in Becker's Hospital Review, a leading publication for hospital leaders, its apparent cynicism about what once were considered indispensable characteristics of good leadership was disturbing.  It is also disturbing that at the time this was written, the only comment on the on-line version of the article, also the only comment to note this lack, was written by your this humble scribbler.

Summary

This may test some CFOs' sense of humor, but instead let me propose my hopes for better health care leadership. To truly reform health care we should seek reasonable leadership that draws on the collective knowledge and values of health care professionals, and that shows accountability, integrity, transparency, honesty, and ethics.  Not asking our leaders to be honest, ethical and accountable just enables the current dysfunction.