Cambridge University Hospitals Trust IT Failures: An Open Letter to Queen Elizabeth II on Repeated EHR Failures, Even After £12.7bn Wasted in Failed NHS National IT Programme

Dear Queen Elizabeth,

I am an American citizen who has written for years about healthcare information technology mismanagement (IT malpractice), dangers to patients of this technology when faulty in healthcare, and the huge mania or bubble that has surrounded this technology in a layer of fairy tales that has cost your Kingdom's treasury, as well as that of the U.S., dearly.

Your subjects seem unable to learn from their mistakes, or learn even from free material at sites such as this, or at my academic site at Drexel University at http://cci.drexel.edu/faculty/ssilverstein/cases/.

Instead of being appropriately skeptical, they spend your citizen's money extravagantly and with abandon on grossly faulty computing.  This results in serious health care meltdowns such as I observed at my September 22, 2011 post on your now-defunct National Programme for IT in the National Health Service (NPfIT).  That post was entitled "NPfIT Programme goes 'PfffT'" and is at http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html.

In that post I observed:

... [NPfIT] also failed because of collective ignorance of these domains [e.g., healthcare informatics, social informatics, etc. - ed.] among its leaders, and among those who chose the leaders. For instance, as I wrote here:

The Department of Health has announced the two long-awaited senior management appointments for the National Programme for IT ... The Department announced in February that it was recruiting the two positions as part of a revised governance structure for handling informatics in the Department of Health.

Christine Connelly will be the first Chief Information Officer for Health and will focus on developing and delivering the Department's overall information strategy and integrating leadership across the NHS and associated bodies including NHS Connecting for Health and the NHS Information Centre for Health and Social Care.Christine Connelly was previously Chief Information Officer at Cadbury Schweppes with direct control of all IT operations and projects. She also spent over 20 years at BP where her roles included Chief of Staff for Gas, Power and Renewables, and Head of IT for both the upstream and downstream business.

Martin Bellamy will be the Director of Programme and System Delivery. He will lead NHS Connecting for Health and focus on enhancing partnerships with and within the NHS. Martin Bellamy has worked for the Department for Work and Pensions since 2003. His main role has been as CIO of the Pension Service.

Excuse me. Cadbury Schweppes (candy and drink?) The Pension Service? As national leaders for healthcare IT?

Also see my August 2010 post "Cerner's Blitzkrieg on London: Where's the RAF?" at http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html.

It's clear medical leaders in the UK learned little from the £12.7bn NPfIT debacle.  Now we have this:

Addenbrooke's Hospital consultants concerned over online records
BBC News
31 July 2015
http://www.bbc.com/news/uk-england-cambridgeshire-30393575

A £200m online patient-record system has been "fraught with problems" and medics' concerns "seemingly overlooked", senior hospital consultants have claimed.

A letter seen by the BBC reveals management at Addenbrooke's and Rosie hospitals in Cambridge were told of "serious" issues last month.  It came after the hospitals transferred 2.1 million records in October.

The trust said "unanticipated" issues led to "more than teething problems". 

The hospital is the first in the UK to use Epic's eHospital system, which is used in hospitals in the US.

To the CEO, these problems are just "hiccups":

... Chief executive Dr Keith McNeil admitted there had been "more than teething problems" and "some of it was anticipated and some of it was unanticipated". The "unanticipated" problems included problems with blood tests and "one of the busiest periods in the hospital's history", he said. He added: "We're profoundly sorry about that... people will understand that you can't do an information technology implementation of this size without some hiccups.

"Hiccups" are a euphemism for incompetence in system design, implementation and testing before it is used on live patients, Your Majesty.  I also note that a close relative of mine, and numerous other patients I know of are severely injured or dead due to these "hiccups."  

And now this:

Addenbrooke's and Rosie hospitals' patients 'put at risk'
BBC News
22 September 2015
http://www.bbc.com/news/uk-england-cambridgeshire-34317265

One of the UK's biggest NHS trusts has been placed in special measures after inspectors found it was "inadequate".

Cambridge University Hospitals Trust, which runs Addenbrooke's and the Rosie Birth Centre, was inspected by the Care Quality Commission in April and May.

Inspectors expressed concerns about staffing levels, delays in outpatient treatment and governance failings.

... Prof Sir Mike Richards, the Care Quality Commission's (CQC) chief inspector of hospitals, said while hospital staff were "extremely caring and extremely skilled", senior management had "lost their grip on some of the basics".

"[Patients] are being put at risk," he said. "It is not that we necessarily saw actual unsafe practice but we did see they would be put at risk if you don't, for example, have sufficient numbers of midwives for women in labour."

The trust, which is said to be predicting a £64m deficit this year, has apologised to patients.

I note that these hospitals had been the beta site for the first implementation of U.S. EHR maker EPIC company's product of the same name.  That £64m deficit looks a bit suspicious for IT overspend; for example see this U.S. hospital's experience of going in the red over fixing 10,000 "issues" (problems) with EPIC, in my post of June 2, 2014:  "In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red" at http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html.

... Perhaps the most worrying aspect of the Addenbrooke's story is not that such a world-renowned hospital has ended up in a predicament like this, but rather that it happened so quickly.

A year ago the trust which runs the hospital - Cambridge University Hospitals NHS Foundation Trust - wasn't even on the Care Quality Commission's radar in terms of being a failing centre.

I suggest a deep connection between this rapid fall, and the rapid rise of an EHR - an antiquated term for what is now an enterprise command-and-control system for hospitals.

... In fact, two years ago - as the regulator was embarking on its new inspection regime - it was among the band of hospitals considered to be the safest, according to the risk-rating system at the time.

But now a hospital which can boast to being a centre of excellence for major trauma, transplants, cancer, neurosurgery, genetics and paediatrics, has been judged to be a basket case and will join the 12 other failing hospitals already placed in special measures.

In my view, a major disruptive technology such as a new EHR is the Number One suspect in such a fall.

... Certainly it seems to have made mistakes - as the troubles with its £200m computerised patient records programme illustrates - but it's hard to escape the feeling that this is just the tip of the iceberg.

The "troubles with its £200m computerised patient records programme" is likely the iceberg, not just its tip.

The Care Quality Commission ("The independent regulator of health and social care in England", http://www.cqc.org.uk/) investigated these hospitals and issued a report, located at http://www.cqc.org.uk/location/RGT01/reports.

Among their key findings were:

Introducing the new EPIC IT system for clinical records had affected the trust’s ability to report, highlight and take action on data collected on the system. 

Excuse me?   Spend £200m on a computer system, and the result is impaired ability to report, highlight and take action on data collected?  Something is very wrong here.

 ... Although it was beginning to be embedded into practice, it was still having an impact on patient care and relationships with external professionals.

Clearly, the CQC does not mean a positive impact.

... Medicines were not always prescribed correctly due to limitations of EPIC, although we were assured this was being remedied.

Spend £200m on a computer system and the result is medicine prescription impairment (with the risks to patients that entails)?  Excuse me?

If those "limitations" affect these British hospitals, what "limitations" on getting prescriptions correct exist in all the U.S.-based hospitals that use this EHR, I ask?

... There was a significant shortfall of staff in a number of areas, including critical care services and those caring for unwell patients. This often resulted in staff being moved from one area of a service to another to make up staff numbers. Although gaps left by staff moving were back-filled with bank or agency staff, this meant that services often had staff with an inappropriate skills mix and patients were being cared for by staff without training relating to their health needs.

I suspect many staff were so unhappy with the EHR that they left, and recommended others not come.

Despite this patients received excellent care.

Odd how patient care and safety is never affected by bad health IT, as in the myriad stories at this site under the indexing key "patient care has not been compromised" (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).

... Clinical staff were not always able to access the information they required – for example, diagnostic tests such as electrocardiographs (ECGs) to assess and provide care for patients. This was because ECGs had to be sent to a central scanning service to be scanned into the electronic recording system [a.k.a. EHR] once the patient had been discharged. This meant their ECGs would not be available for comparison purposes if a patient was re-admitted soon after discharge.

Very, very bad IT planning, potentially putting unstable patients at risk.  Cybernetic miracles always have "fine print" that needs be read by skeptical managers BEFORE implementation.

Where agency staff were used, they were not always able to access information about patients they were supporting. 

 Ditto.

... Some staff told us there were no care plans on the new IT system.  Some staff told us the doctors’ orders had replaced care plans on the new EPIC IT system. These orders were task-orientated and did not always reflect the holistic needs of the patients.

This defective arrangement sounds like it was designed by non-clinicians.   The hubris and arrogance of non-clinicians sticking their heads into clinical issues - especially those of an IT-management background - must be witnessed to be fully comprehended.  It is my belief that such individuals should be subject to the liability as are the clinicians whose work increasingly depends on these IT systems.   If you dare to stick your neck into clinical affairs regarding systems upon which clinicians depend, you should be subject to the same liabilities as a clinician.  Unfortunately, this rarely if ever occurs.

 ... Whilst there were up-to-date evidence-based guidelines in place, we were concerned that these were not always being followed in maternity. This included FHR monitoring, VTE and early warning score guidelines. Staff were competent and understood the guidelines they were required to follow, however, lack of staffing and familiarity with the computer system (EPIC) made this difficult.

The point being missed here is that paper records required no massive multi-hundred page training manual in order to to perform basic functions such as the above.  The complexity of EHRs is costly, unnecessary, impairs clinicians and the solution is a massive scale back and simplification of these systems' complexity and scope.  Unfortunately, that, too is unlike to happen until the negative impacts become increasingly visible and intolerable - a meltdown I predict will occur, eventually.

... Since the introduction of EPIC, outcomes of people’s care and treatment was not robustly collected or monitored. For example, there was no maternity dashboard available since December 2014.

Again, spend £200m and have this result?  Something is seriously wrong here.  I suspect it is that personnel no longer had the time to perform monitoring, as they were likely distracted and struggling to keep afloat with more fundamental medical issues (like keeping major mishaps from occurring) using a complex and buggy EHR system.

That theory is likely confirmed by the following:

... At unit level we observed examples of excellent leadership principles; however, leadership of the directorate overall required improvement. This was because senior managers had not responded appropriately or in a timely way to known and serious safety risks, there was a general lack of service planning, and because key performance data was not being collected robustly and therefore not being analysed. We recognised that EPIC was the root cause of the problems with data collection, and that prior to its introduction in October 2014 many of the data collection issues were not apparent, however, improving this issue was not seen as a priority.

Management, I suspect, became complacent due to their infatuation with cybernetics and a belief that with a big-name EHR in place, operational ills were accounted for and they could relax.  (I've written of this phenomenon as the "syndrome of inappropriate overconfidence in computing.")  Management complacency, bad health IT and struggling clinicians is a very, very bad combination.

... Staff understood their responsibilities for safeguarding children, and acted to protect them from the risk of avoidable harm or abuse. There were enough medical staff but there were nursing shortages in some areas, such as in the day unit and in the neonatal unit. The new ‘EPIC’ (a records management system) computer system added to pressures on staff but effective temporary solutions helped to protect patients.

In other words, workarounds were used to get around the work-impeding EHR.  Workarounds introduce yet more risk.

... the electronic records system (EPIC) created significant numbers of delayed discharges that impacted on patients receiving end-of-life care.  ... Many staff said they had struggled with EPIC and it was time consuming. The specialist palliative care team found patients dropped off the system, so kept two lists to avoid losing patients.

One does not struggle with paper records.  (My current colleagues tell me the EHR struggle is non-ending.)  I further note that a computer system's rights, it appears, took precedence over patients' dying with dignity.

... While introducing EPIC, processes to deal with remaining paper records were unclear. For example, staff documented follow-up appointment requests on notepads. Paper records which were not stored in EPIC were inconsistently stored within the outpatients department. Inaccurate discharge summaries led to a risk that patients would not receive appropriate follow up care.

A fetish to totally eliminate paper, even where paper is the best medium for a purpose (e.g., as here:  http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story), creates major chaos and increases risk.

In conclusion, Your Highness, it might benefit your citizens (and those of the U.S.) if a national re-education programme were instituted to de-condition your leaders from unfettered belief in cybernetic miracles in medicine, a mental state they attain in large part due to mass EHR vendor and pundit propaganda.

A more sober mindset is recommended by your subject Shaun Goldfinch in "Pessimism, Computer Failure, and Information Systems Development in the Public Sector" (Public Administration Review 67;5:917-929, Sept/Oct. 2007, then at the University of Otago, New Zealand): 

The majority of information systems developments are unsuccessful. The larger the development, the more likely it will be unsuccessful. Despite the persistence of this problem for decades and the expenditure of vast sums of money, computer failure has received surprisingly little attention in the public administration literature. This article outlines the problems of enthusiasm and the problems of control, as well as the overwhelming complexity, that make the failure of large developments almost inevitable. Rather than the positive view found in much of the public administration literature, the author suggests a pessimism when it comes to information systems development. Aims for information technology should be modest ones, and in many cases, the risks, uncertainties, and probability of failure mean that new investments in technology are not justified. The author argues for a public official as a recalcitrant, suspicious, and skeptical adopter of IT.

Such a mindset would be helpful in preventing massive wastes of healthcare Pounds, Euros and Dollars better spent on patient care than on cybernetic pipe dreams.

Sincerely,

S. Silverstein, MD
Drexel University
Philadelphia, PA

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

Addendum:

I would like to hear from those in the know if my suspicions are correct.  Please leave comments.

-- SS

11:29 AM

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

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

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

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

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

FierceEMR.com
July 13, 2012

By Dan Bowman

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

5:55 AM

If The Military Can't Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?

The publication "The Machinery Behind Healthcare Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records" on May 16 2009 in the Washington Post (my comments here) exposes a massive lobby that has grossly over-represented the benefits of healthcare IT, committed a cross-disciplinary invasion of medicine, and created a myth about HIT's supposed transformative powers in curing healthcare's ills.

Since its publication in the Post I have become concerned that the research literature that exists extolling healthcare IT may be tainted by corporate influence. The phenomenon of tainted biomedical literature is certainly familiar to readers of Healthcare Renewal and other medical blogs regarding pharmaceuticals and medical devices.

Electronic health records systems can facilitate, not revolutionize, medicine when led by competent experts cross-trained to a meaningful extent (i.e., graduate level or beyond) in both clinical medicine and information science and technology, e.g., biomedical informatics professionals. Even these professionals must often expend much effort in "managing the mismanagement" by incompetent and/or conflicted IT and hospital leadership. (An example of a tightly run and highly specialized project in a high risk medical subspecialty that did have tangible clinical and some financial returns, via identification of poorly performing medical devices -- not something the medical device industry cares for -- is here. This type of project is not easily portable.)

Making yet another case for how the concept of national electronic health records is probably a bad idea at this point in time with respect to our understanding of health IT and its social-technical interactions and challenges, it appears the military's EHR system AHLTA is simply a disaster. [Note: this is not to denigrate the military, and I am very thankful to all who serve and defend our country and freedoms. HIT problems seem unfortunately universal - ed.] All of the preventable elements I've written about are present: unreliability to due inadequate attention to resilience engineering, a mission hostile user experience, time-wasting, demoralization of clinicians, and a cornucopia of other predictable (to informatics experts) consequences when health IT is managed by anyone other than experts.

Just as our economy and culture are now falling apart at the seams as a result of decades of mismanagement and corruption, from micro to macro levels, in most domains (borrowing a phrase from Rev. Jeremiah Wright, "the chickens are coming home to roost"), so the wages of incompetence and corruption in healthcare and healthcare IT are rearing their ugly head. This is the situation in the setting of a relatively constrained patient population (primarily active military personnel and families):

U.S. Medicine - the Voice of Federal Medicine

May 2009

Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress - By Sandra Basu

WASHINGTON—AHLTA, the Department of Defense’s $4 million [sic - that should be $4 billion - ed.] electronic medical record system, continues to be difficult for military physicians to use, according to top military health leaders who spoke at a House Armed Services subcommittee hearing at the end of March.

At a Congressional hearing titled “AHLTA is ‘Intolerable,’ Where do we go from here?” top Department of Defense and service leaders told members that medical personnel are hampered by an electronic medical record system that, among other issues, is slow, difficult to use, unreliable and frequently crashes.“Being the first service to vigorously support the fielding of AHLTA five years ago, we faced a near mutiny of our healthcare providers, our doctors, our nurse practitioners, physician assistants and others last summer,” Army Surgeon General Lt. Gen. Eric Schoomaker, MC, USA, told committee members at a joint hearing held by the Military Personnel Subcommittee and the Terrorism, Unconventional Threats and Capabilities Subcommittee.

Committee members also voiced concern about how the system was impacting provider morale and patient care. “The committee has heard from military doctors and nurses who use AHLTA that it is unreliable, difficult to use and has decreased the number of patients they can see each day. We have also heard that medical professionals leave the military because of their frustration with AHLTA,” said Rep. Joe Wilson, R.-S.C., ranking member of the Military Personnel Subcommittee of the House Armed Services Committee.

Difficult for physicians to use. Intolerable. Slow. Unreliable. Frequently crashes. Near mutiny. Morale. Affecting patient care, decreasing patient load. Can it get worse?

Yes:

A Troubled System

AHLTA is currently deployed worldwide to 70 hospitals, 410 clinics and 6 dental clinics. In addition, the system is used in 14 theater hospitals and 208 forward resuscitative sites.

While Army, Navy and Air Forcer medical leaders who testified all stressed the importance of an electronic medical record [perhaps due to lobby influence and myth-making? - ed.], they all expressed frustrations with AHLTA. Dr. Schoomaker told committee members that medical personnel, particularly specialists, often “spend as much or more time working around the system as they do with the system.” He said that the services are still not effectively able to seamlessly access complete data of patients from the battlefield between the military treatment facilities and the Department of Defense and the Veteran’s Administration.

Last year he said he knew he had a problem when he asked a physician who is a self-described “super user” of the system whether she was a “super fan” of the system and she responded that she was not. “When our best and most faithful users of AHLTA could not admit to being fans of the system, I knew we were really having serious problems,” Dr. Schoomaker said.

When the Army's Surgeon General observes that clinicians "spend as much or more time working around the system as they do with the system", and that the superusers are not enthusiastic about the system, and a Congressional hearing is held entitled "where do we go from here?" (it's clear to this author that they have no clue), one should start to very critically question basic assumptions about health IT. Who said it's a powerful tool to improve healthcare and reduce costs? Who said it's ready for national dissemination? What conflicts do such individuals have with the health IT industry?

He blamed the system’s failures on a lack of a clear-cut strategy for implementing AHLTA—a problem he believes still exists. “In my opinion, the failures of AHLTA can be attributed to the overall lack of a clear, actionable strategy and poor execution from its genesis. As a result of the MHS’s lack of an information management/information technology strategy up to this point, theArmy Medical Department has been largely frustrated by a number of obstacles that continue to impede the system’s capabilities and functionality,” he said.

He also said that the services should have a greater input in decision making regarding AHLTA. “Military health system information technology investments and solutions should be transparent to the services sitting here at the table and should be jointly governed, meaning that we with service input are treated as principal customer clients of the system and that we are heard and acted upon promptly,” he said.

As a faculty member in a College of Information Science and Technology where undergraduates and graduate students are taught the importance of information science and consideration of the needs of end users as a primary enabler of IT success, how can there be a "lack of an information management/information technology" strategy in this national health IT project? How can there have been a lack of input into decision making by the services in the development and deployment of AHLTA?

Leaders from the Navy and Air Force detailed the challenges that their personnel face in using AHLTA. “Almost all of the providers I spoke to relate to the system going down unexpectedly, recently at least once a week,” Navy Deputy Surgeon General Rear. Adm. Thomas R. Cullison, MC, USN, told committee members. He added that while no one would like to return to paper records, providers are “largely dissatisfied” with the system and that the system slows down their clinic time. “Most of our providers say they have to stay later in the afternoon to finish up notes simply because it slows down clinic time,” he said.

Air Force Deputy Surgeon General Maj. Gen. Charles Bruce Green, USAF, MC, told the committee that Air Force primary care physicians spend about 40 percent of their time working with AHLTA versus 60 percent of their time with patients. On the other hand, specialists are “working around the system trying to find new solutions,” since the system does not address the needs unique to their practices. In his written testimony, Dr. Green said that the problems associated with AHLTA have resulted in “low productivity and provider morale.”

Forty percent of clinician time spent tinkering with balky computers? This should be astonishing to any reader unfamiliar with these issues, and an eye opener to our governmental representatives not just regarding the military, but regarding the entire lobby-promoted scheme to force clinicians to adopt HIT by 2014 or suffer financial penalties.

Specialists "working around" the system (thus risking the dangers of workarounds of HIT deficiencies observed by Koppel and others) because it does not meet the needs of their subspecialties? No surprises here. After reading about issues in development of domain specific healthcare information systems for high risk subspecialties (such as here), it should be obvious that the business IT-dominated health IT industry as it currently exists cannot fill such needs.

More importantly, I feel the AHLTA project is an illustration of what will be reproduced, thousands or tens of thousands of times over, in hospitals and physician practices all over this country as we proceed in a national EHR initiative based on false premises borne of the health IT lobby.

The Problem

Then-Assistant Secretary of Defense for Health Affairs S. Ward Casscells, M.D., told committee members that many of the problems that AHLTA has suffered have been “self-inflicted wounds,” due to software contracts with vendors that were “poorly written.” “We have had, over the past decade, contracts that were poorly written from the standpoint of performance, they have loopholes in them that permitted delays. We have, in some instances, lax oversight of some of these contracts,” he said.

Unbelievable. Hospitals sign HIT contracts putting all liability for system defects on clinicians, and that gag them from disclosing defects outside their organizations. The military's HIT contracts apparently had additional flaws that are probably pervasive in the commercial sector as well.

... In moving forward to rectify AHLTA problems, DoD has adopted a Unified Strategy Regional Distribtion Approach, a three-phased plan for reshaping the electronic health system. In written testimony, Dr. Casscells explained this strategy seeks to “improve provider satisfaction, improve reliability and strengthen data sharing throughout DoD and Department of Veterans Affairs healthcare delivery continuum and with private healthcare providers.” The first phase of the approach will focus on “stabilizing performance, reliability and the core infrastructure,” of the system according to Casscell’s written testimony.

"I want to be wary of overpromising. We have done that in the past [indeed, the entire HIT industry has massively overpromised for decades - ed.], but I am excited about this. I think there is a chance here that we can once again be leaders for the nation in electronic health records, as was the case several decades ago. I would like to think that a year or two from now, you will agree with me that AHLTA has gone from intolerable to indispensible,” Dr. Casscells told committee members.

Tommy J. Morris, acting director in DoD’s office of the Deputy Assistant Secretary of Defense for Force Health Protection and Readiness Programs, said that the only service that nonconcurred with their proposed blueprint to overhaul AHLTA was the Army [not exactly an unimportant stakeholder - ed.]

Dr. Schoomaker, on his part, challenged the notion that there was actually a “strategy” in place for rectifying AHLTA. “Mr. Morris has got a plan, he does not have a strategy. We asked for a strategy. A plan is just one element of a larger strategy. We asked for a strategy and our involvement in that strategy, so with respect, that is what we in a sense partially nonconcurred with,” Dr. Schoomaker said.

"I've got a plan." How familiar a refrain that is in a time of mass societal mismanagement.

If I were a politician examining health IT, I'd really start looking into how our government became convinced health IT was not only a worthwhile investment, but an "economic stimulus." As with our friends up north, it seems to be primarily a stimulus for poseurs and dyscompetents to come out of the woodwork, disrupt healthcare providers, and then collect massive fees for the "favor."

In consideration of the above, I ask:

If the military, with its internal discipline and ability to take over entire modern countries with just a few thousand soldiers lost, and its constrained patient population (active military personnel and families generally free of complex and chronic illnesses) can't get electronic health records right, why would anyone think inept and sometimes corrupt EHR companies, dyscompetent hospital IT departments, and reckless and cavalier hospital executives can?

I reiterate my concerns that the "AHLTA experience" will become all too familiar to hospitals and physician practices throughout this country, unless sanity and rationality is restored to our thinking about health IT.

-- SS

4:40 AM

Dangerous Health IT Mismanagement, Spin Control and the World's Longest Teething Pains

I've written about a physician who documents the HIT travails Down Under that parallel the ones we have here - and are going to have a lot more of in a mad rush to universal health IT supposedly by 2014.

Staff in an Australian Hospital's ED basically revolted against a new system that totally failed ... twice in three days. The two accounts of the incident are interesting regarding the incompetence level that hospital IT departments are permitted and that is widely tolerated as if they were a priesthood, and the spin control often used as CYA for events that carry great potential for patient harm.

Physicians should only have it one hundredth as well as IT personnel.

Account 1:

Hospital records system fails twice in one week

ABC (Australian Broadcasting Company) News

Posted Fri May 8, 2009 7:37am AEST

Emergency doctors at Nepean Hospital in Sydney's west are scaling back a new electronic records system because of two failures in the space of four days.

Hospital management says there was a slowdown in the system for two hours on Tuesday, following a widespread outage on Saturday.
Staff at the Nepean Hospital have now stopped using some parts of the system, saying they have lost confidence in it. Medics will in some cases go back to using pen and paper to record patients' progress.
The chief executive of the Sydney West Area Health Service Professor Steven Boyages has apologised to staff, but says the problems could continue for a year and a half, while the technology is being rolled out.
"Like in every other industry, whether its banking or retail or travel, teething problems do occur," he said.
"Whenever you experience a computer slowdown it's enormously frustrating. Particularly if you're dealing with patients."
But Professor Boyages says patient safety has not been compromised. "The important thing to re-assure your listeners is that we have very effective back up systems in place," he said. [That's what's known as "spin control" - ed.]

This raises several questions:

• Computer systems that are up 24/7 are fairly common, including health IT systems. Who, exactly, is having "teething pains?" Surely not the entire healthcare or health IT industry, unless one considers the possibility of a baby that has thirty years worth of little teeth coming in. Perhaps it's incompetent IT department leaders who are doing the teething, at patient and physician expense?
• A year and a half of more problems expected during "rollout?" [That's simply insane -ed.] What in hell is being rolled out?
• Why, exactly, did the system slow down and then fail? Who was in charge of the project and of system architecture and redundancy? What sanctions do they face as a result of this debacle?
• In the often chaotic environment of emergency medicine, disruptions to record keeping, even short lived ones, run the risk of irreversible error or catastrophe. Evidence of the concern of staff is their rejection of the system. How can the chief executive state that safety has "not been compromised?"
• "Very effective backup systems in place?" Since the computer system went down, clearly this exec is not talking about IT. Perhaps the "backup system" is good, old fashioned paper and pencil?

Others share my concerns, as well as concerns that these systems can be more of a hindrance than a help if designed improperly (the identity of the system is not mentioned, unfortunately).

Account 2 of same story:

Electronic medical records putting patients at risk – Nepean Hospital

Posted 07/05/2009 at 05:12 PM by StreetCorner.AU

Staff in the Nepean Hospital Emergency Department have banned the use of the new electronic medical records system after it failed for the second time in three days on Tuesday, putting patients at risk, Shadow Minister for Health Jillian Skinner said today.

According to Jillian Skinner, medical officers have revealed the latest shut down at the Nepean Hospital ED on Tuesday lasted for two hours, leading to staff deciding on Wednesday they no longer had faith in the new system.

“Staff report the electronic medical records system is so cumbersome that senior medical officers who previously saw 8-10 patients in a shift, are only getting through 5-7 because they spend so much time trying to access or enter information” said Mrs Skinner [a.k.a. a mission hostile user experience, itself potentially deadly in an emergency department - ed.]

“When the system failed again on Tuesday it meant there were no records of what a patient was there for, no record of treatment so far, no record of tests ordered, no record of test results and no record about what medication may have been given. Skinner reported that emergency staff at Nepean Hospital decided yesterday to pull the pin on using electronic records and are now working with pen and paper because they don’t trust electronic medical records system.

A situation in an ED where "there are no records of what a patient was there for, no record of treatment so far, no record of tests ordered, no record of test results and no record about what medication(s) may have been given" would seem to my medical mind to reflect a risk to patient safety. Fortunately there are some in the press who report such issues in a credible manner.

It also seems this system either presented a Mission Hostile User Experience, or a Blue Screen of Death User Experience to clinical users.




Considering the contractual blackout that exists in the U.S. on information regarding health IT failures, one wonders how many situations of failure "that don't compromise patient safety" occur on a daily basis on this side of the equator.

At some point, hospital IT departments and leaders will need to be subject to the same rigor as other key hospital employees. Letting them act as an unaccountable priesthood who, when they screw up, are given absolution by executives equally complicit in defending the mediocre, rather than being subjected to Darwinian forces, must end before patients get killed.

-- SS

12:03 PM

Medical Cyber Piracy: Are National Electronic Health Records Plans Premature?

In 1961, President John F. Kennedy stood before a joint session of Congress and declared:

"It is time for a great new American enterprise -- time for this nation to take a clearly leading role in space achievement, which in many ways may hold the key to our future on earth ... First, I believe that this nation should commit itself to achieving the goal, before this decade is out, of landing a man on the moon and returning him safely to the earth. No single space project in this period will be more impressive to mankind, or more important for the long-range exploration of space; and none will be so difficult or expensive to accomplish."

In setting such an ambitious goal, the President was primarily putting at risk a handful of volunteer astronauts, several of whom actually did perish in the effort.

In 2009, President Obama committed the U.S. to full interconnected electronic health records (EHR's) by 2014.

In doing so, the President may be putting at risk millions of non-volunteer, ordinary people if the following is an example of what we can look forward to:

Authorities Hunt Hackers in Breach of Va. Health Data

By Brian Krebs and Anita Kumar
Washington Post Staff Writers
Thursday, May 7, 2009 2:06 PM

RICHMOND, May 7 -- The FBI and Virginia State Police are searching for hackers who have demanded the state pay them a $10 million ransom by Thursday for the return of millions of personal pharmaceutical records they stole from the state's prescription drug database.

The hackers claim to have accessed 8 million patient records and 35 million prescriptions collected by the Prescription Monitoring Program.

... State officials learned on April 30 that hackers had replaced the site's homepage with a ransom note demanding the $10 million payment [hence my title of medical cyber piracy - although perhaps I should call it cyber terrorism? -ed.] in order to receive a password needed to retrieve the records, according to a posting on Wikileaks.org, an online clearinghouse for leaked documents.

The program's computer system has been shut down since last week's breach, but all data were backed up and those files have been secured, Whitley Ryals said. Virginians are still able to get prescriptions filled.

"We do have some of systems restored, but we're being very careful in working with experts and authorities to take essential steps as we proceed forward," she said. "Only when the experts tell us that these systems are safe and secure for being live and interactive will that restoration be complete."

State law requires the agency notify individuals whose personal information may have been accessed. Officials are working with state attorneys to figure out how and when they will do that.

The state-run database allows doctors and pharmacies to track powerful narcotics and painkillers to reduce the abuse, theft and illegal sale of the controlled substances sold under labels such as OxyContin and Vicodin. It was set up as a pilot program in southwestern Virginia in 2003 and expanded statewide in 2006.

Emily Wingfield, chief deputy director of the Department of Health Professions, said the database contained 31.3 million prescription records as of Jan. 1. About 1 million records are added every month, she said.

[And now the customary disclaimer - ed.] State officials say they have no evidence that any personal information is at risk, but they recommend that anyone concerned about possible identity theft keep track of personal financial statements and periodically review credit reports.

Only the world's dreamiest and most naive optimist could believe that these occurrences of medical cyber piracy - or worse - would not become commonplace, with rapid expansion of a diverse array of commercial electronic health records systems among our nation's thousands of hospitals and hundreds of thousands of practitioners.

This is especially true at our current levels of information technology, but also at "our" (meaning, the existing pool of IT professional's) current levels of competence and intellectual capability to manage this technology.

This story in today's Wall Street Journal is another case in point along those lines:

FAA's Air-Traffic Networks Breached by Hackers
By SIOBHAN GORMAN

WASHINGTON -- Civilian air-traffic computer networks have been penetrated multiple times in recent years, including an attack that partially shut down air-traffic data systems in Alaska, according to a government report.

The report, which was released by the Transportation Department's inspector general Wednesday, warned that the Federal Aviation Administration's modernization efforts are introducing new vulnerabilities that could increase the risk of cyberattacks on air-traffic control systems. The FAA is slated to spend approximately $20 billion to upgrade its air-traffic control system over the next 15 years.

The increasing reliance of modernized systems on the Internet "is especially worrisome at a time when the nation is facing increased threats from sophisticated nation-state sponsored cyber attacks," wrote Assistant Inspector General Rebecca Leng.

... Security tests identified 763 "high risk" vulnerabilities that could allow hackers access to administrative systems, which could then provide a path to more-sensitive operational systems, the report said.

... Last year, hackers of unspecified origin "took over FAA computers in Alaska" to effectively become agency insiders, and traveled the agency networks to Oklahoma, where they stole the network administrator's password and used it to install malicious codes, the report said. These hackers also gained the ability to obtain 40,000 FAA passwords and other information used to control the administrative network, it said.

In February, another cyber break-in yielded the personal information of 48,000 current and former agency employees.

"The threat of hackers interfering with our air-traffic control systems is not just theoretical; it has already happened," said Republican Rep. Tom Petri of Wisconsin, one of the lawmakers who requested the report. "We must regard the strengthening of our air-traffic control security as an urgent matter."

In Nov. 2008 I wrote in a post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" that 2009 might not be the optimal time for a major national health IT initiative, and that a moratorium on such efforts should be considered. I amplified the point in this followup post and at these posts as well.

The Virginia prescription records debacle adds to my concerns.

There are some national initiatives, such as a lunar landing, that are supported by a likely, relatively small extension of existing technologies, plus a low risk factor or risk factor to a small number of people. There are other national initiatives whose time may not yet have come due to technological limitations, but even more importantly, due to the advanced technology developed by the (brilliant) few outpacing the capabilities of the (average) many to manage it properly.

One needs to ask - without conflict of interest - if the risks of any mass social and technological engineering initiative such as national EHR's are truly outweighed by the benefits at this point in time. This is not an easy decision.

The common refrain that to not proceed with national EHR now would "hold back innovation", however, is one of objectification of the people. It is a "HIT live or let die" philosophy (let people die, or be injured physically or socially, so that IT may live) in my opinion.

I report, you decide.

-- SS

May 8, 2009 addendum:

The "live and let ... die" attitude can be seen in the concluding paragraph in a response by AMIA to Penn researcher Ross Koppel's JAMA article "Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians."

The AMIA response here (PDF) concludes with this paragraph:

While we support increased transparency around error disclosure, the belief that the best approach to increase the safety and effectiveness of EHR systems is by legal regulation of system vendors is misplaced. Such an approach would stifle innovation and not achieve the desired goals.

I am sympathetic to these concerns, but only to the extent that I can tolerate the commentary's apparent irrationally exuberant and naive character.

I ask: how, exactly, are the beliefs "misplaced"? Who actually holds "misplaced" views? Those people who argue for patient and medical professional rights, a cautious approach to HIT, and regulation (as has occurred for decades in other biomedical industries such as pharma and medical devices), or those people who believe vendors can be counted on to disclose defects 100% by themselves on an "honor" system, without regulation?

Ironically, I believe their is much to be learned from another Penn researcher, in an article published in today's Philadelphia Inquirer:

Posted on Fri, May. 8, 2009
Looking back, years after Penn gene-therapy death
By Marie McCullough
Inquirer Staff Writer

This is one of the strongest cautionary tales regarding the unbridled drive for "innovation" that I've seen in some time.

-- SS

11:01 AM

BLOGSCAN - At UMDNJ, Lose Your Job, Keep Your Cell Phone

We have frequently discussed the plight of the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest health care university in the US. Facing indictment for federal crimes, the university operated under a deferred prosecution agreement and the supervision of a federal monitor from 2005 to 2007. We most recently blogged about UMDNJ here, and see links backward to previous posts from here. On the University Diaries blog, Prof Margaret Soltan discussed the latest aspect of mismanagement at UMDNJ to be uncovered.

10:40 AM

UPMC as "Proving Ground" for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?

Hospitals as a "Proving Ground" for tests of unproven health IT - upon children?

At my post "BusinessWeek on Health IT: The Dubious Promise of Digital Medicine" I began to discuss the responses made by health IT vendors and organizations regarding HIT problems and defects, raised in a very serious April 23, 2009 BusinessWeek article on these issues.

In this post I address the following claims regarding UMPC and a controversial Dec. 2005 article by a UPMC physician in the journal Pediatrics ("Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System", Yong Y. Han et al. -- my comments on this paper at that time were at this link).

BusinessWeek wrote:

... [HIT vendor Cerner] faced more questions over its technology at the University of Pittsburgh Medical Center (UPMC). In 2005 researchers there [i.e., Han et al. - ed.] found that at the university's Children's Hospital [note that this is a Children's Hospital - ed.], patient deaths more than doubled, to 6.6% of intensive-care admissions, in the five months following the installation of a computerized order-entry system. The research on child patient deaths at the University of Pittsburgh found a "direct association between [computerized records] and increased mortality," according to an article published in December 2005 in the medical journal Pediatrics. Digital technology slowed treatment in several ways, the researchers concluded. One example: Doctors and nurses in the intensive-care unit were accustomed to ordering medications and tests while a sick child was en route to the hospital.

The Cerner system required that orders be submitted only when the patient arrived, costing crucial time. The authors of the Pediatrics article acknowledged that their work clashed with other studies showing that digitization decreases errors and shortens hospital stays [but also is consistent with another body of literature (examples here) that Health IT vendors and others with conflicts of interest simply ignore, as per my numerous HC Renewal posts on the issue. Pharma should only have it as good - ed.]

G. Daniel Martich, chief medical information officer at UPMC, says the Pediatrics study was flawed. Factors other than the installation of computers, such as the centralization of pharmacy services, also disrupted care, he emphasizes. The problems identified in the 2005 paper have all been resolved, Martich adds. "There were workflow issues," he says. "We learned the hard way because we were pioneers." Over the long run, he says, technology has helped decrease mortality rates and cut medication errors in half at Children's Hospital since 2003 .

Again, I emphasize we are considering the healthcare of children in this matter.

Here are my observations and questions:

• Why is the 2005 paper simply being dismissed? This is not a scientific approach to the peer reviewed literature, especially where the deaths of children are concerned. I believed in 2005 and believe now that the red flags raised by this paper may have been "brushed under the carpet" too rapidly. See my 2005 post on the matter.

• The implication that the Cerner CPOE was uninvolved in the increased mortality would itself require a very careful observational study to ferret out the exact contributions of its deficits and that of the "centralization" of pharmacy services and other factors. Has such a study been performed and peer reviewed, and has a rebuttal been posted by the original study's authors? Can such a prospective study even be performed after the fact?
  

• While CMIO G. Daniel Martich claims "the problems in the 2005 paper have all been resolved" [wait - I thought the paper was flawed, yet it illustrated problems now resolved? - ed.], how can patients be assured of this? Where are the studies that show the issues have all been resolved?

• Does the damning commentary by the UK's former NHS HIT Director Richard Granger, stories such as patients going untreated for months at a time related to Cerner Millennium Care Records Service ("If NPfiT were a jumbo jet heaven help 747 flyers"), an equally damning report in Jan. 2009 on Cerner's EHR products (i.e., "Millenium") as reported by the UK House of Commons Public Accounts Committee, and the impact on the UK's £12.7 billion national Health IT project suggest a systemic problem needing investigation?

Martich also makes the fantastic claim that "we learned the hard way because we were pioneers."

Pioneers?

Pioneers in what, exactly?

As a former NIH informatics fellow and then former CMIO myself more than a decade ago, it seems more likely UPHS (as well as the children and their parents, and the pediatricians who held the ultimate responsibility per Koppel and Kreda's Hold Harmless paper in JAMA) learned the "hard way" because the organization ignored the work of the pioneers.

There is literature going back fifty years on the challenges of health IT as mentioned in my many posts at HC Renewal, such as here.

I began my informatics postdoc in 1992-4 working on CPOE implementation at Yale-New Haven Hospital. I'd learned lessons from the writings of others who'd experienced CPOE difficulties years before that, such as (emphases mine):

Massaro TA. Introducing physician order entry at a major academic medical center. I: Impact on organizational culture and behavior. Acad Med 1993;68:20–5. [PubMed]

Summary: In 1988 the University of Virginia Medical Center began implementation of a medical information system based on mandatory physician order entry. The implementation process was much more difficult than expected. The program experienced considerable delays, and cost much more than was originally estimated. Although there were some legitimate questions concerning the user-friendliness of the new technology, these were less significant than the cultural and behavioral problems encountered. The new system challenged basic institutional assumptions; it disturbed traditional patterns of conduct and forced people to modify established practice routines ... The author describes the problems that occurred and the organizational behaviors on which they were based, analyzes the lessons learned, documents the progress that has been achieved, and outlines the challenges that remain. The center's experience provides insight into the issue of technology-driven organizational transformation in academic medical centers. Recommendations for successful introduction of similar agents of institutional change are presented.

and

Massaro TA. Introducing physician order entry at a major academic medical center: II. Impact on medical education. Acad Med 1993;68:25–30. [PubMed]:

Summary: The introduction [in 1988] of an information technology (IT) system that mandates order entry by physicians had significant and often unexpected effects on medical education at the University of Virginia Medical Center. The system was deactivated briefly after the introduction of laboratory ordering, and frustration with the pharmacy ordering pathways provoked a major confrontation between the residents and medical center management. Changes in responsibilities, patterns, and priorities of work introduced by the system also contributed significantly to the general dissatisfaction. These issues had not been thoroughly considered in the planning stage, but it was only after accommodation was made to these changes that integration of the technology into routine practice could proceed. The author emphasizes the importance of extensive involvement and leadership of attending physicians in the planning and implementation of such a system. He presents a set of recommendations to those considering similar IT initiatives and wishing to reduce the disruptions that may accompany their introduction. With time and experience, however, the housestaff have adjusted to the system and developed facility in using it. Much of the dissatisfaction was derived from the perception that "doctors spend too much time on the computer." In fact, less than 10% of the physicians spent more than an hour each day. However, a small group of residents on call for the busier services were sometimes at the computer for more than four hours each day.

The entire thirty year old field of Social Informatics spells out the dangers of unintended consequences, and books such as Lorenzi and Riley's "Managing Technological Change: Organizational Aspects of Health Informatics", which contains enough information to have allowed avoidance of the issues in the 2005 paper, was first published in 1994.

My website on HIT difficulties would have helped avoid these issues as well, and it has been online and nearly unique (and the top hit on queries on 'healthcare IT failure' - click here - and similar) for a decade. Did anyone in this CPOE project do such a search, read it, and perhaps query its author about the material [of course not - ed.] before spending tens of millions of dollars and putting patients at risk?

In other words, was true due diligence performed? Considering this was a Children's Hospital, one would have expected extraordinary levels of due diligence.

Pioneers learning the hard way? No. It seems this medical center was a pioneer in ignoring the lessons of the past. I believe a simpler explanation of the difficulties in this CPOE project might be that, like many HIT projects, the project was mismanaged.

Perhaps Dr. Martich meant UPMC were pioneers in this particular new CPOE system. As in this article in the Pittsburgh Tribune:

The University of Pittsburgh Medical Center is taking another step in a quest to commercialize new medical technology.

UPMC on Monday signed a three-year deal with health care information technology provider Cerner Corp. to develop and market medicine-related technological advances. Both parties will contribute $10 million in cash, services and intellectual property to the effort.

The deal is a smaller version of an April 2005 deal between UPMC and information technology behemoth IBM.

As is the case in the IBM deal, UPMC will serve as a built-in proving ground for jointly developed technologies and products, with Cerner marketing the products and UPMC awarded a share of profits.

"Proving ground?"

I cannot believe I am reading such a claim. A hospital and patients, as I have written before, are not a learning lab for HIT vendors. The appropriate "proving ground" for new medical technology is the controlled clinical trial where participants (in this case, patients and healthcare professionals alike) have freedom of choice whether or not to participate, and a chance to give (or deny) consent after being fully informed of potential risk.

Were patients or their parents asked to give consent to the use of HIT (such as here)? Were they even aware they were serving as subjects of a "proving ground?" Likewise for clinicians?

It should be kept in mind that in this "proving ground" (i.e., experimental) situation we are dealing with children. Using a hospital as a "proving ground" for unproven HIT on unconsented or coerced subjects (e.g., children, their parents, and the doctors themselves) probably amounts to battery at the very least, is consistent with violations of fiduciary and Joint Commission safety standards, and I am concerned about it representing human rights violations as well.

In view of the recent Koppel and Kreda paper in JAMA on "hold HIT vendors harmless" and "defects gag" clauses, this entire arrangement seems incredibly disturbing at the very least.

I also believe the conflict of interest represented by a healthcare organization partnering with a vendor to "commercialize new medical technology" on unconsented subjects while sharing profits is a horrendous development, for as I stated, the appropriate settings for such practices are properly conducted, impartial clinical trials. The potential for abuses in the current arrangement seems uncomfortably high.

My sentiments seem aligned with IOM's recommendation 4.1 and others on Conflict of Interest as pointed out by fellow HC Renewal blogger Bernard Carroll at this post:

Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research…” (page S-14).

One wonders if the individuals involved in the CPOE project had unreported conflicts of interest with the HIT industry. Perhaps, as in pharma, this needs to be explored.

Han's 2005 article in Pediatrics suggesting children died as a result of the "experiment" should probably be further explored on the basis of the issues I raise above. I also note Han is no longer at UPMC; perhaps his treatment after publication of this article should also be investigated.

In Dec. 2005 on this blog I wrote:

... This study is dealing with children, of course, and is perhaps a flag that much more detailed study of these systems, especially in socially-sensitive environments such as pediatrics, need to be performed.

For if this study's findings are not just due to serendipity and do reflect some underlying causation, the medical, ethical and legal issues could be enormous.

I stand by that assessment.

Finally, putting the camera to my statement that medicine is suffering a cross occupational invasion by the IT industry, in Business Week the picture below appeared of a handsome and proud physician in his office:

Cerner CEO Neal Patterson

Oh, wait...

That person is not a physician nor does he have any medical experience of which I am aware. He is the CEO of the Cerner HIT company.

This picture is the future face of medicine, and it will not be the brightest of futures if this cross occupational invasion continues unopposed by those of a scientific and biomedical mindset much longer.

I really do believe it is the time for a Congressional investigation of these issues, and strong consideration of FDA regulation of health IT, a precedent set long ago in the pharmaceutical industry.

-- SS

Addendum: I note in Dr. Martich's bio an impressive list of medical credentials; however I find formal Biomedical Informatics and/or computer science training lacking. This is not to attack the person, but the culture of HIT, as this scenario is common in HIT and represents what I refer to as "amateurs" running health IT.

I use the term "amateur" not derisively, but in the same sense that I am a radio amateur (albeit licensed after examination at the Extra class and in the "old days", when 20 WPM morse code proficiency was also required). I am not a telecommunications professional. While I have excellent skills in telecommunications theory, hardware, antennas, and operations, I would not consider myself even remotely qualified to, say, run a strategic telecommunications project for a large organization.

In medicine, I always believed education was critical. I may have been mistaken.

6:38 PM

Should Google Seek the Resignations of Those Responsible for This Healthcare IT Debacle?

Simply amazing. One of the richest and most "leading edge" IT companies in the world with almost unlimited resources and access to expertise commits one of the most fundamental biomedical information science (a.k.a. informatics) blunders, as in the taxonomy in my post here, at the level of "likely to cause patient harm in short term if uncorrected."

I have repeatedly written over at least the past ten years that applying the leadership and methodologies of business IT to clinical computing is both ill conceived and dangerous, as business computing and clinical computing are two very different computing subspecialties, the latter requiring quite specialized leadership and approaches.

I've written it at academic sites, in magazines, in newspapers, and other venues.

Yet, as we have observed at HC Renewal regarding other flavors of healthcare mismanagement and malfeasance, these words seem to suffer an anechoic fate.

Here we go again with another example of what appears to be gross mismanagement of clinical IT by business IT personnel and organizations. The following type of debacle is sooner or later going to kill patients and must end, immediately:

Boston Globe
Electronic health records raise doubt
Google service's inaccuracies may hold wide lesson ["may?" - ed.]
By Lisa Wangsness, Globe Staff
April 13, 2009

WASHINGTON - When Dave deBronkart, a tech-savvy kidney cancer survivor, tried to transfer his medical records from Beth Israel Deaconess Medical Center to Google Health, a new free service that lets patients keep all their health records in one place and easily share them with new doctors, he was stunned at what he found.

Google said his cancer had spread to either his brain or spine - a frightening diagnosis deBronkart had never gotten from his doctors - and listed an array of other conditions that he never had, as far as he knew, like chronic lung disease and aortic aneurysm. A warning announced his blood pressure medication required "immediate attention."

"I wondered, 'What are they talking about?' " said deBronkart, who is 59 and lives in Nashua.

DeBronkart eventually discovered the problem: Some of the information in his Google Health record was drawn from billing records, which sometimes reflect imprecise information plugged into codes required by insurers. Google Health and others in the fast-growing personal health record business say they are offering a revolutionary tool to help patients navigate a fragmented healthcare system, but some doctors fear that inaccurate information from billing data could lead to improper treatment.

(Addendum April 19: a first hand account of this problem is at e-patients.net here.)

What manner of amateurs made and approved the decision to map semantically and often medically imprecise, and often deliberately overstated or misused billing codes to diagnoses, and then display the diagnostic terms to a user - ANY user, patient or "learned intermediary" - in an electronic health record?

Not to mention how poorly conceived and implemented many of the HIT billing systems themselves are, making billing data even less trustworthy...

Injecting humor into a most somber post,
Homer succinctly summarizes the situation.

It is common knowledge to any competent person in healthcare informatics that doing what was done by Google Health is prone to create exactly the kind of situation that occurred.

Insurance data, by contrast, is already computerized and far easier and cheaper to download. But it is also prone to inaccuracies, partly because of the clunky diagnostic coding language used for medical billing, or because doctors sometimes label a test with the disease they hope to rule out, medical technology specialists say.

One does not have to be much of a "specialist" to make this realization. Almost anyone who's ever practiced medicine could probably have told Google's designers, developers and programmers this. This raises a number of questions, which also do not require a specialist to raise:

• What were the designers, implementers and management of this project thinking?
  
• Who was leading the project?
  
• What were there backgrounds?
  
• Who made the decision to implement in this manner?

Danny Sands raises the obvious:

"The problem is this kind of information should never be used clinically, especially if you don't have starting or ending dates" attached to each problem, said deBronkart's primary care doctor, Daniel Z. Sands, who is also the director of medical informatics at Cisco Systems.

Indeed.

Personal health records, such as those offered by Google Health, are a promising tool for patients' empowerment - but inaccuracies could be "a huge problem," ["could be?" - ed.] said Dr. Paul Tang, the chief medical information officer for the Palo Alto Medical Foundation, who chairs a health technology panel for the National Quality Forum.

For example, he said, an inaccurate diagnosis of gastrointestinal bleeding on a heart attack patient's personal health record could stop an emergency room doctor from administering a life-saving drug.

And when such an event occurs and a patient is harmed or killed, who then is held accountable - and who is held harmless? (Oh wait ... we know the answer to that question thanks to Koppel and Kreda...)

This "billing data" issue and other EHR issues like it are not rocket science, they are Medical Informatics 101.

I've seen such issues before, such as at "AOL kerfuffle: information technology vs. information science, a distinction lost at industry's peril" and at "On Intel's and Walmart's prescription for Healthcare IT."

I summed the problem up like this at the post "A Biomedical Informatics Manifesto":

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

(** Amateur in the sense that I am a radio amateur, not a telecommunications professional and would not deem myself appropriate to design and run a critical telecommunications project).

Perhaps, though, I should have added "amateurs rule HIT, and even worse are too often managed by incompetents."

I believe Google should conduct a top to bottom investigation of the management chain and the decision making process that led to such a fiasco, which can only further erode public confidence in electronic health records at a time of national distrust in Big Business and Big Medicine.

Those who made such design and implementation decisions without appropriate input from those who know better, or worse, those who might have overridden or ignored such counsel, should be dealt with appropriately. (If it were me, I'd ask for their resignation, but that's my opinion.)

Clinical medicine, Electronic Health Records and patients' well being are not an information technologists' learning lab.

Also of concern to me, this is the type of data our government seems to be touting for use in Comparative Effectiveness Research. (It is also of concern to me in this regard that our new Secretary of HHS was the former Kansas commissioner for insurance from 1994 to 2002, and such billing data is likely where the majority of her experience with medical datasets resides.)

Finally, like the financial schemes of the past decade, I can only wonder when the computational House of Cards that is being built in healthcare as a result of the quasi-religious Syndrome of Inappropriate Overconfidence in Computing, and worship of its priests, the IT Whiz Kids and consultants to whom domain expertise is optional, will come crashing down.

-- SS

Addendum:

A physician correspondent who wishes to remain anonymous writes (emphases mine):

[The Boston Globe article] could not have come at a better time.

Just today, a spouse had his "home grown" PHR for his wife who was hospitalized with multiple medical problems, including advanced metastic breast cancer and complex vascular disease. He has an elaborate PHR with history, treatments, allergies, medication lists, etc.

It was so impressive that when this 80ish year old patient was admitted, he gave the medication list from the computer to the physicians and nurses. It appeared so reliable that not one health care professional bothered to question it or reconcile it with the labels on the bottles (everyone is so busy nowadays clicking and scrolling the computer silos for information).

As it turns out, he left out a decimal point on a dose of a potent medication that should have been 2.5 mg. The computer printed a legible list (with other errors too) stating the dose of this med was 25 mg per day (10 times too much). It was ordered that way by the doctors. It got to the pharmacy, but somewhere in this complex chain, a non physician non nurse individual got the dose to the patient correctly as 2.5 mg [fortunately, the error was caught, this time. What about next time? - ed.]

Being a detective with an eye for detail and a stickler for accuracy, I happened to notice the error when the spouse was showing off his PHR to me.

Again, this is one case with potentially dangerous consequences of a pervasive error generated in the PHR by flawed data entry. It was not a Google or Health Vault device, but I cannot believe that these companies have garbage filters on their devices to prevent the "garbage in, garbage out" syndrome. Good medical care is being subverted by these experimental devices.

Upon scratching the surface of PHR, EMR, and CPOE devices' functional impact on the administration of medical care, the dangers are widespread. This toxicity is covered up from scrutiny by the "non-disclosures" and "hold harmless" contractual obligations described in the Koppel and Kreda report.

One wonders how many incidents like this happen every day and are being concealed by the HIT industry and the pundits profiting handsomely from selling defective HIT devices. I am quite concerned that nobody really knows. This is not science.

On a final sobering note, as the "hold harmless" and "defects gag" clauses are purged from HIT contracting, which they will most certainly be, I would suggest the many amateurs in HIT obtain some very solid liability insurance covering patient harm related to their systems and their advice.

For they may just find themselves as defendants answering questions on the witness stand in front of a hungry plaintiff's attorney, a jury of average citizens, bereaved relatives of patients who were harmed via IT misadventure, and questions composed by people of my background. These questions will place the true nature of their expertise and qualifications to be tooling around with medical care under severe scrutiny.

That will likely not be very pretty.

-- SS

April 22 addendum:

In comment #15 to this post Matthew Holt issued this filled with absolutes ad hominem comment ...

Seriously, MedInformaticsMD, you are so pissed off with everyone in IT [everyone? - ed.] that you're now part of the problem [problem of vendors creating bad IT? - ed.] Do you seriously think that the people at BIDMC, Google and everyone else in health IT (even Cerner) just dont give a shit? [I cannot read minds. I can only see results - ed.] Or do you think that they might be trying to figure out how to solve these problems [of course they're trying to solve problems, but good intentions without requisite ability and expertise are inadequate in healthcare - ed.], and perhaps could you some constructive help. Rather than a barrage of attacks on anything they try to do. [Anything? You mean, such as in this post praising Google in areas where they do leverage their expertise properly? -ed.]

Perhaps my direct Chairman of Medicine-after-patient-mishap tone in offering the most constructive of criticism - i.e., don't embark on medical projects in which you are over your head, find people who do know the domain and let them lead, don't release anything in medicine without appropriate, rigorous premarket trials - upset him. In addition to the inserts above, in the comments section I replied:

I'm sorry you feel that way.

I'm not sure what "problem" you're referring to, but if it's harming patients due to badly implemented HIT, I'm certainly not part of that problem.

As just one example, my website on HIT difficulties serves as a resource read internationally on how to best avoid HIT errors, has been online for a decade, and is quoted in one of the newest and best books on HIT, specifically "Medical Informatics 20/20."

Did anyone at BIDMC, Google or Cerner ever read it? Did you ever read it? If not, why not? It is in fact the first link that comes up on a google search on "healthcare IT failure", for example. Do they take it seriously? If not, why not?

I believe they were negligent on this project. This suggests they need to give a bit more of a s--- about their work, expecially since real, live patients are involved and the mistake made was so fundamental.

Finally, see my post "A Software Engineer's Eloquence on Health IT" for what I consider an attitude of someone who really does give a s--- about such matters.

Finally, I see no links to my decade-old academic website on HIT difficulties over at Matthew's blog. One wonders why. It may have to do with a tension between the statement that "the Health Care Blog (THCB) has acquired a reputation as one of the most respected independent voices in the healthcare industry" and the post "A Shout out to our sponsors."

Healthcare Renewal has no sponsors and does not take advertising. We report, you decide.

-- SS

4:46 PM