Cerner's Blitzkrieg on London: Where's the RAF?

In the Battle of Britain in WW2, the Royal Air Force (RAF) heroically repelled a foreign invasion of the UK.

The Supermarine Spitfire, key defense tool in the Battle of Britain. (Worked without major glitches.)

Now, the invasion is American, and the battlefield is healthcare...

I have often said health IT remains an experimental technology. However, the technology is being inexplicably force-fed with a vengeance to hospitals by IT companies and governments, force-fed with respect to the actual evidence of benefit.

In the case of the NPfIT in the UK, we have items such as those below from a 2009 government report "The National Programme for IT in the NHS: Progress since 2006 - Public Accounts Committee." Emphases in italics mine:

The termination of Fujitsu's contract has caused uncertainty among Trusts in the South and new deployments have stopped. One option being considered for new deployments is for Trusts to have a choice of either Lorenzo provided through CSC or the [Cerner, an American company - ed.] Millennium system provided through BT. There are, however, considerable problems with existing deployments of Millennium and serious concerns about the prospects for future deployments of Lorenzo. Before the new arrangements for the South are finalised, the Department should assess whether it would be wise for Trusts in the South to adopt these systems. Should either of the Local Service Providers take on additional commitments relating to the South, the Department should take particular care to assess the implications of the extra workload for the quality of services to Trusts in the Local Service Providers' existing areas of responsibility.

The Programme is not providing value for money at present because there have been few successful deployments of the [Cerner] Millennium system and none of Lorenzo in any Acute Trust. Trusts cannot be expected to take on the burden of deploying care records systems that do not work effectively. Unless the position on care records system deployments improves appreciably in the very near future (i.e. within the next six months), the Department should assess the financial case for allowing Trusts to put forward applications for central funding for alternative systems compatible with the objectives of the Programme.

In 2010 Londoners continue to be used as cannon fodder for the health IT experiment, which continues to rain IT bombs down upon them. The result?

Mayhem:

St George’s suffers Cerner teething pain
E-Health Insider
Jon Hoeksma
26 Aug 2010

St George’s Healthcare NHS Trust is facing teething problems with its installation of a Cerner Millennium hospital information system.

"Teething" problems? As if to imply problems with health IT are as minor as an infant's dental discomfort? That's some spin:

Health IT problems? Just baby issues; nothing a good cry can't solve ...

(The health IT baby must have serious endocrinological problems. Even after decades, it never seems to grow up, and is forever teething.)

The spin and excuses surrounding the health IT industry are simply nauseating, considering it's people's lives that are being screwed with.

Let's translate to everyday language: the project has been a disaster.

... The trust went live with the Millennium in March, under a new local delivery model from local service provider BT.

Five months later, the trust, which is one of the largest in London, has had to second additional senior management expertise into the project team and institute an additional programme of workflow changes and training.

The trust says the new system is creating difficulties in tracking patient notes in some areas and in managing outpatient appointments; creating backlogs of work that have required extra staff to deal with.

Health IT is touted as improving clinician-clinician communication. Allow me to translate "difficulties in tracking patient notes." In King's English (as opposed to health IT political-ese and other mumbo-jumbo), this translates to "patient notes are getting lost."

That means that health IT is obstructing patient care. I'm sure the patients didn't consent to the use of unproven technology that could get them killed.

Health IT is also the supposed cure to healthcare's financial and staffing woes:

They have also had a knock-on effect on the trust’s ability to meet and report on activity. Sources familiar with the implementation say the trust was fortunate that the coalition government dropped the national requirement to meet 18-week referral to treatment time targets in the revised NHS operating framework.

The problems are understood to mainly relate to staff finding it difficult to adjust to new processes and to using the unfamiliar Cerner system.

...“Since the programme deployed some staff have found it challenging to follow the new workflows. Therefore, where appropriate, we are simplifying processes by modifying workflows and administrative procedures.”

Translation: staff are finding it difficult to perform clinical-related work according to the capricious diktats of non-clinician health IT developers. In other words, they have difficulty being coerced to work for the computer, instead of the computer working for them.

The south London trust told E-Health Insider this week that the implementation was just the beginning of a major change programme; a project it calls iCLIP.

Only the beginning? God save the King....

“Although we successfully avoided some of the major pitfalls of other deployments, the new systems have presented some challenges to staff, particularly in relation to outpatient clinics and the tracking of case notes,” said chief operating officer Patrick Mitchell in a statement.

How major could those "major pitfalls" have been? Perhaps he means, the software actually runs and no longer crashes?

He added: “We have allocated additional temporary support while the new system and processes fully embed in these areas. A further programme of training and workflow changes are also underway as we continue to support staff and prepare for the next stages of the programme.”

"Temporary?" We'll see about that. Per the recent article "Electronic Medical Records, Nurse Staffing, and Nurse-Sensitive Patient Outcomes: Evidence from California Hospitals, 1998–2007" (Health Services Research, 9 APR 2010, DOI: 10.1111/j.1475-6773.2010.01110.x), on a longitudinal analysis of 326 short-term, general acute care hospitals in California:

... Our results suggest that advanced EMR applications may increase hospital costs and nurse staffing levels, as well as increase complications and decrease mortality for some conditions. Contrary to expectation [I'm not sure whose expectation, and on what basis - ed.], we found no support for the proposition that EMR reduced length of stay or decreased the demand for nurses.

On to the issues of skills:

Julia Crawshaw, the general manager for maternity services, has now been seconded into the project team “to lead on the work looking at optimisation of workflows, operational procedures and further training.”

Will this GM for maternity be looking at workflows in, for example, neurosurgery?

The problems now being addressed occurred despite 1,600 staff being comprehensively trained prior to go-live.

"Comprehensively?" What does that mean, exactly? The results seem to belie that assertion. Or are these systems and their user experience so ill conceived, tedious, cryptic and complex that no amount of "training" is adequate? (I believe the latter.)

However, Mitchell stressed that thanks to the hard work of staff, the new information system is delivering benefits, including “real-time reporting in the A&E department and more complete monitoring of bed occupancy.”

How many millions of pounds and person-years were spent to achieve these startling results, I wonder?

Mitchell said: “Reporting in real-time requires that staff report more promptly and accurately so additional training needs are also being identified to help individual staff become more comfortable with the system.”

Perhaps the system - and its designers - should be "trained" to be more comfortable with the users?

A spokesperson for BT told EHI: “Obviously these are operational issues the trust is dealing with. It is not for BT to comment. But you would expect that on a major deployment programme of this scale there would be issues.”

This is a classic appeal to common practice. Such "issues" might be tolerable for inventory systems of widgets (perhaps Cadbury Schweppes products?), but no, in mission critical areas I would not "expect" problems such as lost clinical notes.

In the most recent trust newsletter, the chief executive said: “I do fully appreciate that iCLIP has been far from smooth sailing. However, all major projects have their ups and downs and I know that many colleagues are focused on the long-term success of this important project.”

More spin and appeal to common practice.

This voyage was smooth sailing, until a little glitch was encountered...

"Far from smooth sailing?" Why does the HMS Titanic come to mind?

... The next trust due to go live with Millennium in London is meant to be Imperial, scheduled to take the system in 2011, under Cerner’s Method M delivery model.

"Method M delivery model"? How many "models" does it take to implement information systems in mission critical healthcare environments?

In summary, the NPfIT, already by the government's admission a multi-billion pound debacle, continues to drag on. Patients and hospital workers are the fodder for this experiment, spearheaded this time by an American invasion.

The Blitz is on.

Unfortunately, this time there's no RAF in sight to repel the foreign invasion.

The upside down world of commercial health IT. Is healthcare in St. George's Trust being incernerated?

-- SS

Cerner - Fuqua School of Business 'Corporate Ethics 101' Paper and Website Disappear

On April 16 at "Healthcare IT Corporate Ethics 101: A Strategy for Cerner Corporation to Address the HIT Stimulus Plan" I wrote about a Duke Fuqua School of Business paper (apparently authored by a Cerner official) promoting a business strategy of regulatory manipulation to restrain the free market for HIT products.

The paper, and the Fuqua School of Business web page "Past Papers" on which the paper was promoted, have both disappeared as of this April 18 writing.

I have posted an image of the "Past Papers" page and updated my link to an archived copy of the paper, but the scrubbing of the Fuqua site and removal of the paper is interesting.

-- SS

Addendum Apr. 19 -

A former HIMSS staffer related to me that I am likely blacklisted from the HIT vendor industry as a result of my writings on health IT on this site and at my academic site dating to 1999, via verbal exchanges and even in writing among HIT organizations. It could explain why my CV's been uniformly ignored by that industry since the early 2000's.

If so, so be it. Who else might be on that blacklist, I wonder?

Also, didn't Richard Nixon get into a bit of trouble for maintaining such a list after it was discovered?

Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'

Combination in restraint of trade: An illegal compact between two or more persons to unjustly restrict competition and monopolize commerce in goods or services by controlling their production, distribution, and price or through other unlawful means. Such combinations are prohibited by the provisions of the Sherman Anti-Trust Act and other antitrust acts.

I have written on these blog pages that the IT industry has staged an invasion of the healthcare professions.

One of these invasions has to do with the ethics of the IT industry, ethics at odds with medical ethics and the Hippocratic oath. The HIT industry is characterized by an overarching interest in profits and cavalier attitudes towards HIT-related adverse clinical events through sales of inferior products (domestically as well as abroad) based on archaic technologies, exaggerated claims of benefits, ultra-aggressive marketing, and legalized suppression of adverse events information about unproven, non-secure, largely experimental health IT medical devices.

I find it truly remarkable, more than 20 years into consumer availability of the GUI, that in the 2009 publication "Principles and Proposed Methods of EMR Usability Evaluation and Rating" (PDF) the major HIT trade group HIMSS admits that:

Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available.

Unbelievable. What has this industry been doing for the past few decades?

Worse, the health IT industry is entirely unregulated and has pushed to maintain that status quo. Now the HIT industry may be clamoring for industry regulation as a means of restraint of trade as described below.

The public is beginning to wake up to the vendor and HIT trade group puffery, at least with regard to security hazards and exaggeration of the benefits:

Electronic health records prompt security, costs concerns
Richmond Times-Dispatch
By Tammie Smith
Published: April 5, 2010

The thought of one's personal medical information being just a computer click away does not sit well with many consumers. In a March 2009 survey of 1,238 randomly selected adults by the Kaiser Family Foundation, the Harvard School of Public Health and National Public Radio, 59 percent of respondents didn't think confidentiality of electronic medical records could be assured ... 76 percent thought it was likely that an unauthorized person would get access to medical records online.

... While there are anecdotal stories of electronic health records improving outcomes, the data are mixed on whether they save money. A Harvard Medical School study published in the American Journal of Medicine last year linked 2003-2007 cost and quality data for 4,000 hospitals, including the 100 "most wired" hospitals. The researchers concluded that the electronic health records systems in place so far "might modestly improve" quality quality but produced no savings on administrative or overall costs.

'Anecdotal'? 'might'? 'modestly'? Is that worth spending hundreds of billions of dollars on, at a time when the healthcare system is struggling to make ends meet, I ask?

Unfortunately, the public and healthcare regulators need a further awakening about the Healthare IT industry's ethics.

A profoundly disappointing lesson in the ethics of the healthcare IT sector (and the B-schools as well) can be gleaned from the following, a paper written by a Cerner employee and two health industry colleagues for a Duke Fuqua School of Business course.

The course is "Health Economics & Strategy (HLTHMGMT 326), Distance Executive MBA" (syllabus here in PDF). The course's stated purpose:

We will apply the tools of economics and strategy to address the challenges and opportunities of today's health care managers and policy makers. We will begin most classes with analysis of recent news, then discuss a case, and conclude with additional insight on the application of economics and strategy.

The paper is entitled -

"A STRATEGY FOR CERNER CORPORATION TO ADDRESS THE HIT STIMULUS PLAN" (PDF).

*** April 18 NOTE: the paper apparently has been scrubbed and is no longer available from the above link as it was on April 16. A copy is here (PDF).

It is actually highlighted at Duke professor David Ridley's page "Duke University Fuqua School of Business: Past Papers."

*** April 18 NOTE: the "Past Papers" page has also seemingly been scrubbed. This is how it looked two days ago:

(click to enlarge)

This appears to be a Final Paper for an online MBA program course for executives. These are therefore not just students in the academic sense; as in my own healthcare informatics courses, I've had 'students' who concurrently were executives and managers in healthcare companies and organizations.

All three authors are listed at business networking site LinkedIn.com:

• Dan Aycock - appears as Business Strategist at Cerner
• Aparna Prasad - MBA Candidate at The Fuqua School of Business, Duke University
• Barri Stiber - Administrative Fellow at Legacy Health - formerly Senior Analyst at The Advisory Board Company

The paper is emblazoned with the Cerner corporate logo on its cover page and could be mistaken for an official document:

Paper's cover page. Click to enlarge

From the paper, an example of HIT corporate ethics (and business school ethics as well):

Electronic health records (EHRs) have the potential to improve the healthcare system through several means including reduced medical errors, better coordination of care, and reduced costs. However, adoption of EHR systems in the U.S. has been slow; only 1.5% of acute care hospitals have comprehensive EHR systems.

While the Bush administration made efforts to spur adoption of these systems, the Obama administration’s American Recovery and Reinvestment Act of 2009 (ARRA) has pushed EHR adoption to the fore with over $20 billion dollars in incentives. With such a large infusion into a relatively small market the effects of the stimulus package have enormous strategic implications for EHR vendors.

This paper seeks to clarify these implications, understand the strengths and weaknesses of various players in the industry and recommend a strategy for Cerner Corporation to maximize its profit from the stimulus package and thereby secure a dominant position in the HIT industry.

... We recommend that Cerner collaborate with other incumbent vendors to establish high regulatory standards, effectively creating a barrier to new firm entry. Other strategic recommendations to capture market share, facilitate EHR adoption, and improve Cerner’s operational readiness are detailed and framed within an implementation plan.

I am going to highlight one key sentence for emphasis:

We - recommend - Cerner - collaborate - with - other - incumbent - vendors - to - establish - high - regulatory - standards, effectively - creating - a - barrier - to - new - firm - entry.

Did I read that correctly?

The paper goes on to explain:

... With the introduction of stimulus funding, this industry is ripe for disruptive innovation, which could significantly change the competitive landscape. Examining Christensen’s work on disruptive innovation outlined in Figure 6, the primary factor that will influence the entry of new HIT vendors is regulation.

Therefore, the technology standards and definitions of “meaningful use” which are under development have the potential to raise or reduce barriers to entry, limiting or enhancing the ability for disruptive innovations to enter at a lower performance point. When asked about which competitors the organization is most concerned about, a Siemens Executive indicated “it is these new guys who could come in and undercut prices with substandard products.”

["New guys" ="substandard"? This from a company that apparently fired an informatics physician for raising concerns that a substandard ICU system was going to kill patients - ed.]

Therefore, incumbent firms, like Cerner, have strong incentives to influence regulation in their favor, keeping barriers to entry high.

[Influence in their favor, not in the favor of patients, to maintain the industry oligarchy? - ed]

In other words, to stifle disruptive innovation and prevent newcomers from entry into the HIT business, large HIT vendors should influence regulation towards high standards impossible for newcomers to meet.

NOT that they should influence regulation for the sake of patient safety!

This student is apparently a Cerner strategist seeking an MBA. His colleague Barri Stiber was a Senior Analyst at The Advisory Board Company, a company that serves "nearly 3,000 progressive organizations worldwide—health care, health benefits, and educational organizations alike—providing innovative solutions to their most pressing challenges such that they can “hardwire” best-practice performance."

This paper raises a number of questions:

• Does this paper reflect a strategy that would amount to illegal restraint of trade and/or fall under the federal RICO act, through knowingly and willfully advancing a lobbying strategy to strangle fair competition?

• Were any of these authors on Cerner's payroll when this was written?

• Are Mr. Aycock or other authors giving such advice to Cerner management presently?

• Did or does Cerner use this paper or derivatives thereof internally?

• Does this paper reflect on the business ethics of Cerner or other large HIT vendors? Will they openly condemn its ideas as both wrong minded and monopolistic, using their influence to create a market adverse to smaller competitors - not to mention the paper's seeming lack of concern for what really matters - the "customer" (patients)?

• Did or does this paper reflect a more widespread healthcare IT large player collusion on restraint of trade?
  

• Is this how the Advisory Board company conducts its business in advising healthcare organizations?

• What type of professor would exalt a paper via posting it as an example for other students to emulate, a paper whose basic premise is unethical, or at the very least on the precipice of unethicality?

• Does this professor teach such ethics?

• Why was this paper not returned to its authors with a big, red "F" on it? That's what I would have done.

• What other papers are accepted by this professor that demonstrate similar business "strategies" in other sectors?

Finally, and perhaps most importantly:

• Does this paper reflect, or did it influence, current Cerner or other large HIT vendor business strategy?
  

Recent developments are consistent with that, i.e., Cerner starting to acknowledge need for regulation, per the Feb. 2010 story "FDA Considers Regulating Safety of Electronic Health Systems" by the Huffington Post Investigate Fund, http://huffpostfund.org/stories/2010/02/fda-considers-regulating-safety-electronic-health-systems).

From that article:

.... Yet some inside the industry favor stepped-up scrutiny. One major vendor, Cerner Corporation, which has voluntarily reported safety incidents to the FDA in recent years, signaled its support for a rule that would make those reports mandatory. Cerner has reported potential safety concerns because it is the “right thing to do,” a company official said.

I was puzzled by that turnaround.

Perhaps now I know from where it arose.

It certainly is the "right thing to do." It's the right thing to do to enhance profits and enforce restriction of market entry by "disruptively innovative" newcomers.

Those newcomers might actually hold the answers to improving healthcare IT and reducing costs through fair, free market competition, saving lives and money the healthcare system dearly needs. (For example, see my post "Hospitals Under the Knife: Sacrificing Hospital Jobs for the Extravagance of Healthcare IT".)

-- SS

Addendum Apr. 16 -

A commenter speculates that:

... When I did my MBA, back in the day, we were one of the first programs to have a working business background as a requirement for admission. From that base I would make the following guesses:

• The people were not only on the company payroll, but also were having their tuition paid for by the company.
• This document was widely circulated within the company,
• The document was highlighted as a means for the university to curry favor with the company thus increasing recruits or for financial gain.

... The modern remote MBA program is in many instances simply a way to check a box for employees on the fast track to senior management. Often papers are written with the support of the company and access to department heads who contribute to material turned in.

From my experience this is not some theoretical exercise, but a document that, even retiled, will be used internally to drive policy.

While that is speculation, it is certainly plausible; nothing would surprise me in the health IT industry.

Addendum Apr. 19 -

A former HIMSS staffer related to me that I am likely blacklisted from the HIT vendor industry as a result of my writings on health IT on this site and at my academic site dating to 1999, via verbal exchanges and even in writing among HIT organizations. It could explain why my CV's been uniformly ignored by that industry since the early 2000's.

If so, so be it. Who else might be on that blacklist, I wonder?

Also, didn't Richard Nixon get into a bit of trouble for maintaining such a list after it was discovered?

-- SS

"We are unable to share documents relating to problematic EHR's as our contract with Cerner includes a confidentiality clause ..."

In my post "Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development" I reported on the Univ. of Sydney's somewhat belated support for academic freedom, and the reappearance of an essay on ED electronic health records problems in NSW by one of its informatics faculty, Prof. Jon Patrick, after an apparently government-initiated attempt at censorship.

A new update of the paper "A Critical Essay on the Deployment of an ED Clinical Information System - Systemic Failure or Bad Luck" version 6, has now been posted by Dr. Patrick at this link on his department's web pages (a direct link at this time to the PDF is here).

The press has started to take notice. A piece in the Sydney Morning Herald entitled "Health department accused of censorship" appeared on Nov. 28 here.

That piece was noted by Computer Weekly in the U.K. in a piece entitled "Claim of censorship over Cerner system" here. The U.K. suffers a severe EHR epidemic (the UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.)

[12/3/09 update: the piece has disappeared, then reappeared, at Computer Weekly. In case it disappears again, a copy of the article from Google's cache is here.]

From the U.K. Computer Weekly article:

The Sydney Morning Herald and ZDNet in Australia report that the University of Sydney removed from its website - temporarily - a negative essay about a Cerner system which had been installed at hospitals in New South Wales.

The author of the essay is a medical IT professor, Jon Patrick, who is reported to have claimed that NSW Health, which is part of the government of New South Wales, put pressure on the university to take down the paper.

If true, it would tie in with what's been happening in England where mentions of Cerner in a negative context are being officially discouraged.

Cerner is due to be installed at hospitals across London as part of the National Programme for IT [NPfIT] but several trusts that have already gone live - including the Royal Free and Hampstead, Barnet and Chase Farm, and Barts and The London - have run into serious problems, including the losing of patient appointments and patients not being treated.

A showcase Cerner site at Homerton ceased mentioning Cerner in its public board papers after doing a deal with NHS Connecting for Health and the Department of Health. Homerton also rejects FOI requests related to its discussions on Cerner.

Homerton told me: "We are unable to share documents relating to these meetings as our contract with Cerner includes a confidentiality clause and as such disclosure of the information could give rise to an actionable breach of confidence."

I am repeating that last sentence for effect:

We are unable to share documents relating to these meetings as our contract with Cerner includes a confidentiality clause and as such disclosure of the information could give rise to an actionable breach of confidence.

This is solid evidence of such confidentiality clauses in HIT contracts and the chilling effect they have, along with dangers of "hold harmless" clauses. This style of EHR contracting is a practice now under investigation by the U.S. Senate Committee on Finance, as in their Oct. 16, 2009 letter to major healthcare IT vendors and management consultants from Senator Charles E. Grassley (ranking member). A copy of that letter is here (PDF).

I have written on the dangers of such clauses before as in my July 22, 2009 letter in the Journal of the American Medical Association "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" (http://jama.ama-assn.org/cgi/content/extract/302/4/382), as well as my much more thorough posting on these issues in the essay at my Drexel University website here.

In that essay I observed:

Regarding healthcare IT "Hold Harmless" and Defects Gag Clauses, I also question whether hospital executives violated their fiduciary responsibilities by signing such contracts, and violated Joint Commission standards of hospital leadership conduct as well ...

Let's look at the Joint Commission Hospital Accreditation Program Leadership Chapter, and its standards for hospital leadership (link, PDF):

Leadership
LD.01.03.01

Standard LD.01.03.01
The governing body is ultimately accountable for the safety and quality of care, treatment, and services.

Rationale for LD.01.03.01
The governing body’s ultimate responsibility for safety and quality derives from their legal responsibility and operational authority for [organization] performance. In this context, the governing body provides for internal structures and resources, including staff, that support safety and quality.

The governing body has a legal responsibility for safety and quality, not just a moral obligation. One of the "internal structures" is healthcare IT that is safe and effective and that does not expose patients or staff to undue risks.

How does signing "hold harmless" and "defects gag order" clauses with an HIT vendor serve such a purpose, exactly?

Hospital executives know, should know, or should have known that such provisions would remove incentives for health IT vendors to produce the best products and to correct deficiencies rapidly, thus increasing risk to patients and clinicians.

Elements of Performance for LD.01.03.01
5. The governing body provides for the resources needed to maintain safe, quality care, treatment, and services.

One of those resources is health IT.

Standard LD.02.01.01
The mission, vision, and goals of the [organization] support the safety and quality of care, treatment, and services.

Rationale for LD.02.01.01
The primary responsibility of leaders is to provide for the safety and quality of care, treatment, and services. The purpose of the [organization]’s mission, vision, and goals, is to define how the [organization] will achieve safety and quality. The leaders are more likely to be aligned with the mission, vision, and goals when they create them together. The common purpose of the [organization] is most likely achieved when it is understood by all who work in or are served by the [organization].

How is a contract with an HIT vendor that calls for hiding defects in health IT and exposing staff to liability for defects in same serving the above purposes?

Standard LD.02.03.01
The governing body, senior managers and leaders of the organized medical staff regularly communicate with each other on issues of safety and quality.

Does that include communication on health IT defects? Can a medical staff member ask to see a database of such defects when the hospital has signed a nondisclosure of defects agreement with an HIT vendor?

Rationale for LD.02.03.01
Leaders, who provide for safety and quality, must communicate with each other on matters affecting the [organization] and those it serves.

I ask the same question as above.

Standard LD.03.01.01
Leaders create and maintain a culture of safety and quality throughout the [organization].

Safety for whom, exactly? Patients, or patients and staff?

How is exposing professional staff to undeserved liability from defective health IT serving the creation of a culture of safety and quality for them? How is suppressing information on health IT defects and problems helping patient safety and care quality?

How is lack of seeking informed consent on health IT use from patients whose care is mediated by health IT devices with known but undisclosable defects creating a culture of quality?

How is hiding such defects creating a culture of quality in the community's other hospitals, that may be considering purchase of the very same health IT?

Standard LD.03.04.01
The [organization] communicates information related to safety and quality to those who need it, including staff, licensed independent practitioners, [patient]s, families, and external interested parties.

Rationale for LD.03.04.01
Effective communication is essential among individuals and groups within the [organization], and between the [organization] and external parties. Poor communication often contributes to adverse events and can compromise safety and quality of care, treatment, and services. Effective communication is timely, accurate, and usable by the audience.

Are physicians and nurses explicitly informed by administration that clinicians are liable for bad outcomes due to software problems? Are they informed of the gag clause? Are patients informed of unremediated health IT defects existing at time of service?

This standard seems a veritable smoking gun regarding breach of fiduciary responsibility and Joint Commission obligations when hospital leadership signs agreements specifically excluding the sharing information about health IT defects and complaints. It is already known that hospitals maintain lists of health IT defects, some in the thousands of items. A number of the defects rise to the level of creating considerable risk to patients, and nobody is in a hurry to remediate them. (See my proposed although somewhat tongue in cheek "HIT Informed Consent" that describes some of these known defect categories here).

Standard LD.04.04.03
New or modified services or processes are well-designed.

... 3. The hospital's design of new or modified services or processes incorporates: Information about potential risks to patients.

4. The hospital's design of new or modified services or processes incorporates: Evidence-based information in the decision-making process. Note: For example, evidence-based information could include practice guidelines, successful practices, information from current literature, and clinical standards.

How does the contractual inability to communicate about health IT defects, which its executives willingly sign, serve this purpose?

Standard LD.04.04.05
The [organization] has an organization-wide, integrated [patient] safety program.

... 12. The hospital disseminates lessons learned from root cause analyses, system or process failures, and the results of proactive risk assessments to all staff who provide services for the specific situation.

Disseminates lessons learned, except when the HIT contract they've signed with a vendor forbids it, that is.

The practices of the health IT industry, and the dealings of the hospital leadership with that industry, may in fact be a scandal of national (or international) proportions.

International scandal, indeed.

I predict these EHR confidentiality clauses will end up causing great loss of money in failed systems, and/or harming patients, due to the chilling effect they have on revelation of defects and problems by clinicians and executives alike.

Those who signed them will very likely be held liable, at least in the U.S., as the clauses breach the safety standards of the accrediting agency for hospitals here, the Joint Commission. I wish the signers of such contracts good luck in the courtroom.

In Australia and the U.K., I cannot comment, but also wish good luck to those who signed these clauses when lawyers go full court press on EHR-mediated debacles.

-- SS

Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development

In "Academic Freedom and ED EHR's Down Under: An Update" I wrote about the disputed essay on electronic health record (EHR) problems in the Australian state of New South Wales (NSW) by medical informatics professor Dr. Jon Patrick, Health Information Technologies Research Laboratory (HITRL), University of Sydney.

The essay was entitled "A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck?"

I am happy to report that an updated version of the essay, version 5, is now available from Dr. Patrick's university web site at http://www.it.usyd.edu.au/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146 . It can be downloaded from the icon at Item 6.

This is a welcome development.

The essay is now labeled as an Op-Ed (Opinion Editorial).

-- SS

Health IT Vendors Trafficking in Patient Data?

Of all of the risks regarding electronic health records, the largest is perhaps to privacy and confidentiality, and other civil liberties through the ability of information technology to rapidly duplicate and disseminate massive amounts of data.

This duplication and dissemination can be performed in a controlled manner for the betterment of patient and public health, but it can also occur in a harmful manner that serves the interests of others, often without meaningful informed consent by the patients (legal jargon on typical disclosure forms that almost nobody reads or understands does not fall into what I consider "meaningful").

This can occur in, for example, the stealing of computers and computer backup disks, tape etc., which seems to be a common occurrence in the news in recent years, or through corporate processes that carry inherent risk of abuse. Here is just one recent example of both data mismanagement and theft involving not patients (by chance) but physicians themselves:

Blue Cross: Thousands of doctors' computer data stolen

Wednesday, October 07, 2009

By Bill Toland, Pittsburgh Post-Gazette

Tens of thousands of doctors under contract with Pittsburgh's Highmark Inc. are being notified that their personal information, including Social Security numbers or tax ID numbers, may have been compromised when a laptop containing sensitive data was stolen from a Blue Cross-Blue Shield Association employee.

Physicians and specialists in western and central Pennsylvania are being notified of the breach this week, according to a Highmark spokesman. Across the country, the number of affected doctors is expected to reach the hundreds of thousands once a review of the theft is complete, said national Blue Cross-Blue Shield Association spokesman Jeff Smokler. The stolen computer did not contain patient information. [Simply due to luck -ed.]

The letter sent to Highmark providers said "a BCBSA employee [transferred] provider data information onto a personal laptop, in violation of BCBSA's established data security policies.

I have recently become aware of an example of purposeful corporate healthcare data trafficking that gives me pause.

Cerner’s LifeSciences traffics in patient data taken from the EMRs its company sells to healthcare organizations. See the document below. They advertise:

Cerner LifeSciences’ data warehouses and consulting services help you manage your R&D opportunity through Cerner’s analytical solutions. Through our data mining of our vast warehouse of electronic health records (EHRs), you can accelerate development processes and reduce business risks. Each year, new compounds debut new abilities or first-in-class molecules. Far more common are new compounds that target the same receptors as compounds already in the market ... This is when Cerner LifeSciences makes it possible to analyze anonymous, HIPAA-compliant, EHR-derived data for efficacy and safety.

Cerner apparently includes contract language with their HIT customers that allows them to traffic in "de-identified" patient data for sale to drug companies and others, getting the data essentially as a "value add" (to the HIT vendor, that is) from its healthcare IT customers. (The flyer below does not indicate pricing of healthcare data, but it's likely substantial.)

A major HIT vendor selling patient data to anyone who wants it. Click to enlarge. (Full copy is at this link in PDF format).

This practice raises numerous questions:

• Meaningful informed consent issues: as an example, of 1000 patients at one of the facilities using this vendor's HIT products, what percentage would be able to tell me they know their data is being trafficked to pharmaceutical companies and other organizations for profit?

• Healthcare data ownership and stewardship issues: who, exactly, extracts the data for aggregation and sale? Hospital employees properly trained and bonded (i.e., Healthcare Information Management professionals) regarding privacy of patient data? IT personnel lacking such credentials and experience? HIT vendor employees?

• De-identification issues: what processes are being used to de-identify data? Who is performing it? At some point before the data is de-identified, it is protected information in identifiable form. Is access to the data during de-identification audited in any way, and if so, by whom? If not, why not? (Also see article on re-identification below.)
  

• Legal issues: who is, by contract, liable for data breaches that occur in the transfer process?

• Fiduciary issues: as I expressed in my July 22, 2009 JAMA letter to the editor regarding "vendor hold harmless" and IT defects gag clauses, are hospital executives further violating their fiduciary responsibilities by signing HIT contracts that surrender ownership of patient data to third parties? (see my posts "JAMA letter: Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" and "Inquiry to Joint Commission on points I raised in my JAMA letter on HIT" for more on those issues.

• Pharma integrity issues: with the many stories on this blog and others about ethically questionable pharma practices such as ghostwriting, manipulation of clinical research, suppression of research, pushing drugs on physicians and patients for unapproved off-label uses, etc., what are these organizations going to do with the data? Who will have access to it, and will their access be audited? Are they going to resell it? Might they try to re-identify data to locate individuals of interest? And so forth.
  

Serious consideration of these issues in vendor-led healthcare data trafficking becomes more imperative in the face of just how easy it is to "re-identify" data:

Ohm, Paul: "Broken Promises of Privacy: Responding to the Surprising Failure of Anonymization" (August 13, 2009). University of Colorado Law Legal Studies Research Paper No. 09-12. Available at SSRN: http://ssrn.com/abstract=1450006

Abstract:

Computer scientists have recently undermined our faith in the privacy-protecting power of anonymization, the name for techniques for protecting the privacy of individuals in large databases by deleting information like names and social security numbers. These scientists have demonstrated they can often 'reidentify' or 'deanonymize' individuals hidden in anonymized data with astonishing ease. By understanding this research, we will realize we have made a mistake, labored beneath a fundamental misunderstanding, which has assured us much less privacy than we have assumed. This mistake pervades nearly every information privacy law, regulation, and debate, yet regulators and legal scholars have paid it scant attention. We must respond to the surprising failure of anonymization, and this Article provides the tools to do so.

Further, Cerner is digging deeper into the life sciences, licensing its "Discovere" system to clinical trials vendor such as Quintiles Transnational (link to story in Bizjournals.com):

Quintiles will use Cerner’s Web-based Discovere product, whose features include the ability to integrate data from study participants and site researchers and increase data quality by reducing transcription errors, the companies said in a release. A Cerner spokeswoman said the company isn’t disclosing financial terms of the deal.

According to an entry at HISTalk, part of "Discovere" is the former First Genetic Trust technology that Cerner bought some time ago. Quintiles signed an agreement with Cerner back in 2001 and took an equity position in it. The Discovere modules include biobanking, research registries, public health investigator workflow, clinical trials management, and adverse event reporting.

Is Cerner also selling HIT-gleaned patient data to Quintiles and other CRO's (clinical research organizations)?

Other HIT vendors are sure to follow in Cerner's footsteps for competitive reasons, if not already doing so.

Another major issue:

HIT vendors like this are devoting resources to profit from medical data, diverting resources from their core business. Might health IT vendors make better use of their resources, such as improving the core products they sell to hospitals and clinicians, avoiding the "mission hostile user experience" I wrote about in this eight part series?

Might they devote resources to solving problems that are affecting entire national health IT programs, instead of peddling data from the systems they have managed to implement to third parties?

From the UK's experiences as recorded in 2007 by the former head of their National Program for HIT in the NHS (NPfIT):

Richard Granger has said he was “ashamed of the quality of some of the systems put into the NHS by Connecting for Health suppliers”, singling Cerner out for criticism (link). Going further than he before in acknowledging the extent of failings of systems provided to some parts of the NHS - such as Milton Keynes – the Connecting for Health boss, said "Sometimes we put in stuff that I'm just ashamed of. Some of the stuff that Cerner has put in recently is appalling."

As recorded in Jan. 2009 by the UK House of Commons - Public Accounts Committee :

... Termination of Fujitsu's contract has caused uncertainty among Trusts in the South and new deployments have stopped. One option: have a choice of either Lorenzo or [Cerner] Millennium. There are, however, considerable problems with existing deployments of [Cerner] Millennium and serious concerns about the prospects for future deployments of Lorenzo.

... Programme not providing value for money at present because there have been few successful deployments of the [Cerner] Millennium system and none of Lorenzo in any Acute Trust. Trusts cannot be expected to take on the burden of deploying care records systems that do not work effectively … the Department should assess the financial case for allowing Trusts to put forward applications for central funding for alternative systems compatible with the objectives of the Programme.

Most recently, in the UK Cerner's Millennium product is blamed for the jump from 1,700 to 23,000 patients whose referrals don’t meet the 18-week target from referral to treatment at Barts and the London NHS trust.

Should HIT vendors be devoting resources to data peddling, instead of focusing on their core mission to produce usable HIT that can facilitate healthcare professionals in providing care?

Finally, as an added item of interest, our current healthcare "czar", Nancy-Ann DeParle was on the board of Cerner just prior to appointment in the current administration.

All of these issues considered, while I am not implying improprieties current or future, the possible permutations of problems in the resale of clinical data by HIT vendors potentially created by careless data stewardship, profit motive, conflict of interest, malevolent motives, etc. is endless.

If there ever were a scenario for civil liberties groups to explore, it's this one.

-- SS

addendum on HIT quality and COI issues: found this at HISTalk as well:

IT outsourcing puts MU Health at risk

An associate professor of pathology at University of Missouri criticizes his employer’s decision to outsource to Cerner … A simple Internet search turns up a plethora of complaints and reports of lawsuits regarding the effectiveness of Cerner’s software and, more important, its failure to provide requested support. The pattern of receiving untested software has been a recurring problem at this institution ...

... University Hospital’s success depends largely on the effectiveness of the people in information technology. In the past on two occasions, the billing was so flawed the hospital faced serious fiscal problems. The most recent one was in 2002, when the hospital’s viability was threatened. The major issue was the inability to produce accurate and timely billings, which cost the system millions of dollars. [where have I seen that before? How about: here (Yale) and here - ed.]

... The medical school’s administrative residency program is on probation and is undergoing critical review; a major factor is that the Cerner system is so cumbersome that resident training is compromised … Three years ago, the radiology department dropped a Cerner software program because it was seriously flawed.”

... [UM President] Forsee has several business and personal ties to the company (Cerner). Forsee and Cerner CEO Neal Patterson serve together on at least two boards of trustees, and online records indicate Forsee’s son-in-law, Brandon Bell, works for Cerner.”

If this all is true, I believe the problems with HIT in general are no better now, and probably worse, than when I started writing about such issues a decade ago.

I rest my case on whether the HIT vendors should focus on solving basic quality, usability and efficacy issues before peddling data ...

-- SS

Physicians Down Under Get Direct About Danger of Bad HIT

Too often, physicians acquiese to demands by hospital executives that they adjust to and use health IT, even if that health IT is flawed. This is despite the fact that liability for patient care resides with the physicians, not the HIT vendor or executives.

Several physicians Down Under have had enough:

Doctors issue deadly warning
Daily Examiner, Grafton, Australia
David Bancroft | 23rd July 2009

It seems incredible that a patient record system that aims to improve treatment could kill people [not so incredible to the informed - e.g., see "Bad Informatics Can Kill" - ed.], but that is a claim being made about a new system that is almost certainly going to be introduced into the Grafton Base Hospital next week.

Earlier this month, leading health officials from the Lismore Base Hospital wrote to the North Coast Area Health Service (NCAHS) claiming a new Surginet electronic medical record system that had been operating in the hospital for several months would 'inevitably' lead to the death of patients.

But the health service said changes had been made to the Surginet electronic medical record (EMR) system since the concerns were raised by the four senior clinicians on July 2, and the system had been operating 'satisfactorily' in Sydney without patient concerns being raised. ["Without concerns raised" does not mean they do not exist - ed.]

In their letter to NCAHS chief executive officer Chris Crawford, which was copied to the Minister for Health John Della Bosca, the four medical specialists said there had been recurring problems over several months and 'these have not improved'.

“This has resulted in unnecessary compromise of patient safety,” they wrote.

“There have been repeated well demonstrated cases of near miss disasters due to these problems. [Will patients be as lucky the next time? - ed.]

“We believe that negative patient outcomes, including death, will inevitably result from the continuing use of this system.

“Surginet is fundamentally flawed.

“New technology should: improve the quality of our work; help us to be more efficient, and; make routine tasks easier.

“EMR Surginet does none of these; in fact it has had the opposite effect.

“We believe that the Surginet EMR system is unsafe and will result in patient morbidity and mortality.”

Surginet was to be implemented at the Grafton Base Hospital yesterday, but after concerns were raised with the area health service, implementation was delayed until next Wednesday.

A health service spokesman said the implementation had been delayed so the software producers, Cerner [an American company behind the HIT products that caused difficulty in the UK - see the UK House of Commons report here, esp. points 5 and 6 - ed.], could speak with Grafton surgeons and anaesthetists prior to the implementation about any concerns they may have.

“NCAHS takes any concerns raised about patient safety seriously and is addressing these,” the spokesman said.

“It should be emphasised that Surginet is operating satisfactorily in Sydney hospitals without patient safety concerns being raised. [Again, that does not mean they do not exist; clinicians may be afraid to speak out and working furiously to establish workarounds to problems - ed.]

“It is a system used worldwide that can be adapted to accommodate local work practices in NSW hospitals. ["Can be adapted" - anything "can be adapted". But has this application actually been adapted to the culture in NSW hospitals? - ed.]

“Arrangements are being made for discussions to be held with the department heads by representatives of the EMR project team and Cerner.”

The spokesman said Surginet had recently been introduced at the Maclean Hospital and there had been no complaints and the NCAHS had actually received a letter of thanks from the hospital. [A letter of thanks from whom at the hospital, exactly, and based on what substantive claims? - ed.]

Such discrepancies between one hospital and the next regarding HIT require critical evaluation - erring on the side of patient safety, not IT vendor convenience. Considering the aforementioned UK House of Commons report and the "near miss disasters" mentioned by the Australian physicians, such due diligence is mandatory in my opinion.

Further, American physicians can probably learn from these Australian counterparts in being vocal about HIT problems.

-- SS

IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans Medical Centers

Bill Gates's company, Microsoft, touts the User Experience as the Sine Qua Non of computing. Billions of dollars have been spent tweaking every little nuance of Windows, with version 7.0 soon to appear. Apple has done likewise with Mac OS X. (The various X-windows managers for Linux, less so). I respect these efforts and use both mainstream OS's in my daily work.

In HIT, however, the "user experience" as I outlined in my eight part series starting here is deemed an issue to solve once the sale is made and physicians are scrambling to avoid harming or killing patients. After all, the HIT industry is unregulated, shielded from liability based on the "learned intermediary" doctrine (a.k.a., clinicians are the bank and insurance company for IT vendors, in that they are the creative implementors of workarounds to IT mismanagement and misdesign), and contractual gag clauses against public disclosure of product defects.

This arrangement makes the pharmaceutical industry look like kids in a sandbox.

In the article "IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans' Medical Centers", Journal of the American Medical Association 2009;301(9):919-920, author Bridget M. Kuehn illustrates the risk of improperly implemented or managed HIT, even in the VA.

The VA is probably the finest environment in the world for HIT, its development of clinical IT over the past few decades being largely driven by experts from within, and being dedicated to patients and not profits. Yet its HIT is subject to the same issues as HIT in the for-profit HIT sector.

Kuehn writes in JAMA:

Medical errors and software malfunctions that were linked to changes in the electronic medical records system used at Veterans Affairs (VA) medical centers across the country are drawing attention to the potential vulnerabilities of such systems.

Although many advocates of electronic medical records systems promote them as a means to reduce mistakes affecting patient care, the recent problems in the VA system and other evidence suggest that malfunctions of these systems or problems with the way they are implemented have the potential to lead to medical errors.

Drawing attention after how many years of physicians observing such problems in the commercial HIT sector and being muted by HIT companies on such issues, I ask?

How many times will we need to see such articles in print before physicians and patient advocates wake up? How many times would we need to see in print "chiropractors performing neurosurgery is harming patients" before we put a stop to that practice?

How many medical centers have lists and databases of known HIT defects, waiting to be fixed, that their patients and the public do not know of? How many physicians have been threatened with litigation for airing the dirty laundry?

Understanding how such problems occur as well as how they might be prevented is particularly critical as the Obama administration considers health care reforms that include more widespread adoption of electronic records systems in health care.

Indeed, although I would add "... as the Obama administration also moves from a suggested timeline of 2014 to a coercive 'do this or else' timeline."

As I've written, such a change is cavalier and suffers from the misinformation fed the administration by both the HIT ecosystem industrialists and opportunists, and those suffering from the utopian Syndrome of Inappropriate Overconfidence in Computing.

After a software update of the electronic medical records system at VA hospitals in August, health care workers at these facilities began to report that as they moved from the records of one patient to those of a second patient, they would sometimes see the first patient's information displayed under the second patient's name.

If not for the diligence of the users, that type of error could lead to dead patients.

This records-scrambling problem was reported at 41 of the 153 VA medical centers, said Gail Graham, deputy chief officer of Health Information Management at Veterans Health Administration Headquarters in Washington, DC. Graham explained that the jumbling of records was an uncommon occurrence that only occurred after a particular sequence of events.

As I mentioned above, the VA is an example of the finest environment, probably in the world, for HIT, being dedicated to patients and not profits (see the book "Medical Informatics 20/20" by Goldstein et al., and my linked quote, on that culture).

Imagine what goes on in commercial products where vendors' first priority is to profit margin.

Health care workers at the VA medical centers were notified about this potential problem in October, and on December 20, the centers received a software "patch" to fix the problem.

Nine VA medical centers reported another type of problem related to their electronic records system: physician orders to stop medication were missed, causing some patients to receive intravenous medications longer than necessary. The problem occurred because after the software upgrade, physician orders to discontinue such medications, which had previously appeared at the top of the screen, were not displayed.

In 3 cases, patients received infusions of drugs such as heparin for up to 11 hours after their physician had ordered the drug to be discontinued. Graham said the affected patients were not notified because they had not been harmed by the oversights. This software problem was corrected on December 8.

Again, this type of error occurs once too often, your patient's dead.

There are hundreds of types of problems that can occur as a result of such technology, and those experienced by the VA medical centers are not uncommon, according to Ross Koppel, PhD, professor of sociology at the School of Medicine at the University of Pennsylvania in Philadelphia.

For example, the scrambling of two different electronic records is a common problem that is not limited to systems used in health care settings, he said. Additionally, research indicates that poor layout of information in electronic medical records and related health information technology systems is the most common type of flaw (Koppel R et al. JAMA. 2005;293[10]:1197-1203). He explained that when health care workers have to look at several different screens or scroll through pages to access the information needed to make medical decisions, mistakes can occur.

My eight part series came to the same conclusions. In fact, I reached those conclusions and started writing publicly about them, in 1998. Was anyone listening? How many patients have been harmed, or died, in those past ten years due to industry inattention to these issues and leadership of HIT projects by unqualified personnel?

Additionally, medical errors also may arise from poor communication between electronic medical records and related technologies (such as computerized physician order entry systems) or between software applications created by different companies.

Other types of errors are caused not by flawed software but by how workers use that software in real medical settings. For example, an electronic medical record system may require a physician to enter a weight for a patient before prescribing a drug, even if a precise weight is not needed for that particular drug. A physician in a rush may enter an estimate of the patient's weight, but another physician who subsequently views the record might use that estimated weight to prescribe a medication that does require an accurate weight, potentially causing a dosage error. Detecting such problems requires careful observation of how systems are being used in real clinical settings and interviewing clinical staff about their experience, noted Koppel.

I claim these types of errors are due to flawed software. The flaw is in the ill-conceived, management information systems (MIS) inventory-system-mentality, mission hostile user experience the software presents to clinicians.

Although makers of electronic medical records software test it to detect problems that may lead to errors, federal oversight of such testing is lacking. The Certification Commission for Healthcare Information Technology, which is composed of health information technology industry organizations, has a certification program, but critics argue that such oversight is not sufficient and that the US Food and Drug Administration, the Centers for Medicare & Medicaid Services, or a new governmental agency should be given the authority to oversee these systems (Hoffman S and Podgurski A. Harv J Law Tech. 2008;22[1]:104-165).

"The bar on certification has to be raised to a level that ensures real safety, not just minimal compliance," Koppel said.

The CCHIT process is merely a specifications check or qualification of features, and is nearly useless by their own admission regarding most of the issues discussed in these articles. Worse, CCHIT has significant conflicts of interest with the HIT industry, having senior people who also hold senior industry positions and thus have fiduciary responsibilities to their employers (whether that is acceptable for a "certifying" organizations is open to debate, but the conflicts exist as fact). On a more minor point, this organization can't even manage its books properly, failing to file its required reports and temporarily being dissolved, involuntarily.

In fact, let me state that the lack of oversight of this industry amounts to, at best, governmental negligence, and at worst a complete dereliction of obligation to protect the public.

Imagine this type of arrangement in pharma or the (physical) medical device industry. Almost ten years ago I wrote HIT is a clinical tool for unforgiving medical environments that happens to involve computers, not a management information system that happens to involve doctors.

In other words, HIT systems are virtual medical devices that affect every aspect of care, and can cause the "learned intermediaries" to commit error as the JAMA article illustrates.

Koppel also urged caution as electronic records are rolled out. Although these technologies offer great promise in providing data for research and quality-improvement initiatives, he said more work is needed to make these systems work effectively in the context of health care.

"We should encourage [the technologies' development, but we should not force doctors to use them until they are shown to be more responsive to the needs of physicians and other clinicians," he said.

As to the "they", I believe Ross Koppel was referring to the computer artifacts themselves.

I would extend the "they" to mean the healthcare IT vendor industry itself, to most of whose leaders I've probably give an "F" regarding these issues and knowledge of Biomedical Informatics.

Excluding NextGen, whose AVP for Government Relations holds the vaunted and much coveted "American Medical Informatics Certification for Health Information Technology."

Finally, the VA is going to embark on upgrades to its laboratory components not by relying on its internal expertise, but by engaging the services of a private HIT company, Cerner, a company with a troubled record regarding the national IT initiatives in the UK (see here, here).

Considering that company's issues, and the internal complexities, dependencies, intra-component messaging, and other idiosyncracies of a system as complex as VistA, I opine that this is a major error.

Based upon my decades of knowledge about IT, biomedical informatics training, my analytical abilities and my own informed judgment, it is my deep fear that the VA will not "luck out" as in the above JAMA article. Patients will be harmed as a result somewhere down the line, I fear.

-- SS


Addendum 3/5/08:

I am promoting a user comment and my response to the body of this post itself, as I think they exemplify a central issue regarding HIT:

Paul Trossel on March 5, 2009 5:05:00 AM EST said...

Computer software in the Health industry are tools to use. Often the user thinks they are the ‘law’ in what they have to do. As long as people don’t understand the way they have to use their tools (eg surgical scalpel, machines, software etc.) mistakes will be made. Always check the outcome of the computer with your own judgement. As long as supervisors, bosses etc. help their people to understand that the use of the mind of a qualified professional is the outmost important and that the outcomes of the tools are the next, mistakes that lead to the death of a patient, will keep occurring!

My reply:

Mr. Trossel,

Forgive me for saying so, but you sound like an apologist for the Health IT medical device industry, which rightly fears increased scrutiny of its design, development, QC and lifecycle practices.

HIT is a medical device that happens to involve computer automation.

My apologies if I am incorrect, but it appears you're not taken care of a patient in the "fog of war" known as the ED, ICU or busy hospital floor.

Tools that distract, tools that mislead, tools causing cognitive overload are simply dangerous in such an environment. That is a clinical reality.

It is also clear you've not read my post [as above] in its entirety, nor my multi part series on the mission hostile user experience presented by HIT.

It appears even the most highly trained experts, especially when distracted, can be misled by faulty devices.

The recent crash of the Turkish airliner seems a case of just that. See "Altimeter, Crew Cited in Dutch Crash" in the Wall Street Journal.

It is the primary responsibility of the manufacturer of a medical device such as HIT to assure it is the best device possible, accounting for the very well known realities of the clinical workplace.

It is not the responsibility of the end user to be the bank and insurance policy for cavalier software design through tiring improvisation and workarounds to software device mismanagement and design decisions made by incompetents and HIT amateurs.

There is no excuse for ill conceived, designed and implemented HIT devices. None whatsoever, most especially depending on busy human users to compensate for the flaws on a 100% reliability basis.

Resilience engineering, a term I learned when presenting these HIT issues to the IEEE Medical Technology Policy Committee in Dec, 2007 (PPT here), is not about depending on busy people to cover for your device's defects.

Regarding a meta-issue:

It's absolutely a sign of our culture being in great distress when physicians have to answer to IT personnel about why the physicians best not be the "workarounds" and safety valves to ill conceived IT.

-- SS