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

Addenbrooke Hospital Cambridge University Hospitals EPIC healthcare IT dangers healthcare IT risks Mismanagement NPfIT Patient care has not been compromised Rosie hospital

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

Unknown 9/25/2015 Komentar

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

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Politico 2015: EHR sellers using “gag clauses” (despite Koppel/Kreda's 2009 JAMA article on EHR nondisclosure clauses, and my 2009 JAMA Letter to the Editor on how these clauses violate Joint Commission safety standards)

Darius Tahir david kreda defects nondisclosure clause gag clause healthcare IT risks hold harmless clause Politico ross koppel

Politico 2015: EHR sellers using “gag clauses” (despite Koppel/Kreda's 2009 JAMA article on EHR nondisclosure clauses, and my 2009 JAMA Letter to the Editor on how these clauses violate Joint Commission safety standards)

Unknown 9/15/2015 Komentar

I have not blogged on EHR issues in some time, despite some interesting source material such as:

• "Evidence Summary: Electronic Health Records (EHRs)" at http://www.ohri.ca/kta/docs/KTA-EHR-Evidence-Review.pdf ; 
• "Electronic Health Records Software Often Written without Doctors' Input" at http://www.scientificamerican.com/article/electronic-health-records-software-often-written-without-doctors-input/ ; and
• "Avoiding Expensive And Consequential Health Care Decisions Based On Weak Research Designs" [e.g., EHR expansion - ed.] at http://healthaffairs.org/blog/2015/08/31/avoiding-expensive-and-consequential-health-care-decisions-based-on-weak-research-designs/.

These can be read at the links above, and are self-explanatory.

A new Politico investigation and article, however, is worth writing about:
  

Politico
Doctors barred from discussing safety glitches in U.S.-funded software
Darius Tahir
09/11/15
http://www.politico.com/story/2015/09/doctors-barred-from-discussing-safety-glitches-in-us-funded-software-213553

President Barack Obama’s stimulus put taxpayers on the hook for $30 billion in electronic medical records, many of which have turned out to be technological disasters.

But don’t expect to hear about the problems from doctors or hospitals. Most of them are under gag orders not to discuss the specific failings of their systems — even though poor technology in hospitals can have lethal consequences. 

[Change the "can" to "does", e.g., ECRI Deep Dive, http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html - ed.]

A POLITICO investigation found that some of the biggest firms marketing electronic record systems inserted “gag clauses” in their taxpayer-subsidized contracts, effectively forbidding health care providers from talking about glitches that slow their work and potentially jeopardize patients.

[E.g., see http://hcrenewal.blogspot.com/search/label/glitch - ed.]

POLITICO obtained 11 contracts through public record requests from hospitals and health systems in New York City, California, and Florida that use six of the biggest vendors of digital record systems. With one exception, each of the contracts contains a clause protecting potentially large swaths of information from public exposure. This is the first time the existence of the gag clauses has been conclusively documented.

I note this Politico article appears six years after the seminal JAMA article on hold harmless and defects nondisclosure clauses:

• "Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians" by Koppel and Kreda, JAMA 2009;301(12):1276-1278), http://medecon.pbworks.com/f/IT%20Accountability%20JAMA09.pdf,

as well as:

• this author's followup JAMA Letter to the Editor "Healthcare IT, Hospital Responsibilities, and Joint Commission Standards" (can be seen in its entirety at http://jama.jamanetwork.com/article.aspx?articleid=184302) pointing out that such clauses and those who signed them were in violation of Joint Commission safety standards. 
• (I published a longer version at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda.  Also see my 2009 post at http://hcrenewal.blogspot.com/2009/03/health-care-information-technology.html).

In that 2009 JAMA Letter to the Editor I observed:

... In their Commentary, Dr Koppel and Mr Kreda made clear the problems associated with applying the customs and traditions of business software contracting and sales (where “hold harmless” and “keep defects secret” clauses are commonplace) to health care information technology (HIT) as if they are the same. I believe that ignoring their differences has likely created an epidemic of violations of hospital governing body responsibilities and Joint Commission standards for health care organization leadership.

In 2015 I stand by these assertions.  Computer and business personnel - through arrogance, selfishness, narrow-mindedness and other issues - have made a mess assuming that business software practices apply to clinical medicine and healthcare IT.  In the latter domain, however, increased clinical stress and hypervigilance due to bugs clinicians have to work around (that might have been fixed sooner), lessening their performance and increasing risk, and patient injury and death has been the result of a belief that clinical computing is just a niche area of business computing.  (I've been making this point for at least 15 years, I might add.)

Such contractual practices endanger patients, and in 2015 are reckless, negligent and inexcusable.

http://injury.findlaw.com/accident-injury-law/recklessness.html
Recklessness means the person knew (or should have known) that his or her action were likely to cause harm. Negligence means that the person acted in violation of a duty to someone else, with the breach of that duty causing harm to someone else.

More from the Politico article:

Vendors say such restrictions target only breaches of intellectual property and are invoked rarely.

IP breaches?  While I understand the business issues at hand, in reality this is farcical.  There is little unique and valuable IP in these systems...as if one EHR vendor would really copy off another EHR vendor's screens.  I've seen many EHRs and their instruction manuals and in my opinion there's little worth stealing from any of these look-alike systems.

But doctors, researchers and members of Congress contend they stifle important discussions, including disclosures that problems exist. In some cases, they say, the software’s faults can have lethal results, misleading doctors and nurses who rely upon it for critical information in life-or-death situations.

Change the "can" to "do."  See ECRI link above, posts such as at http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html, and as readers here know, I have one less living relative thanks to EHR faults.  (I know of others that I cannot discuss.)

Critics say the clauses – which POLITICO documented in contracts with Epic Systems, Cerner, Siemens (now part of Cerner), Allscripts, eClinicalWorks and Meditech – have kept researchers from understanding the scope of the failures.

I actually refute that.  I believe many researchers (in the field of Medical Informatics, at least) were blinded by their own wishful thinking about health IT and their own misplaced overconfidence in computing.  My writings for a decade and that of many other "iconoclasts", based on experience and insight from other fields in which we worked, clearly raising huge red flags, were derided or summarily ignored.  For instance, see my post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" from almost exactly five years ago at http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html.  There was enough data to ascertain that major problems were extant.

Even the ECRI Deep Dive EHR safety study referenced above, now at least three years old, finding 171 IT mishaps in 9 weeks in just 36 hospitals voluntarily reported, causing 8 significant harms and 3 possible deaths, is rarely cited by the "researchers."  See http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.

... Sheldon Whitehouse (D-RI) asked a panel of witnesses [during a HELP committee hearing earlier this summer], including Allscripts CEO Paul Black: “Can anyone on this panel see a single reason why these contracts should have gag clauses in them?”  No one ventured a reason.

Perhaps, I ask, because it would be hard to say something like "Senator, our computers have more rights than patients, and we don't give a damn about patient harm as long as the $$$ keep rolling in, and payouts for screw-ups that do make it to court are manageable", Ford Pinto-style, in such a setting?

After POLITICO disclosed its findings, an aide to HELP Chairman Lamar Alexander (R-Tenn.) said the committee would look at the issue, “exploring potentially harmful effects of these clauses – including how they could inhibit interoperability.”

The interoperability issue is a diversion if not a non-sequitur.  Dreamers still believe billions will be magically saved, and lives saved, via "interoperability", ironically at a time when basic operability is poorly achieved.

Let me state this clearly:  health IT will always be a major cost center and will never result in the mass cost savings attributed by the pundits to it.  From experience, I state that is a pipe dream, a fantasy, a risible statement consistent with a mania over the technology.  The issues in medicine that cost dear money are complex, and are not amenable to solution via cybernetic miracles.

See http://hcrenewal.blogspot.com/2012/09/wsj-koppel-and-soumerai-major-glitch.html for more on this issue:

... a comprehensive evaluation of the scientific literature has confirmed what many researchers suspected: The savings claimed by government agencies and vendors of health IT are little more than hype.

To conduct the study, faculty at McMaster University in Hamilton, Ontario, and its programs for assessment of technology in health—and other research centers, including in the U.S.—sifted through almost 36,000 studies of health IT. The studies included information about highly valued computerized alerts—when drugs are prescribed, for instance—to prevent drug interactions and dosage errors. From among those studies the researchers identified 31 that specifically examined the outcomes in light of the technology's cost-savings claims.

With a few isolated exceptions, the preponderance of evidence shows that the systems had not improved health or saved money.

Rather than saving money, the industry is sucking in some of that $17 or so trillion the United States just doesn't have (http://www.usdebtclock.org/).  See for instance "The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records", Washington Post, by Robert O'Harrow Jr., May 16, 2009.

Back to Politico:

... Take Cerner’s agreement with LA County’s Department of Health Services, signed in November 2012 and worth up to $370 million. It defines the vendor’s confidential information as “source code, prices, trade secrets, mask works, databases, designs and techniques, models, displays and manuals.” Such information can only be revealed with “prior written consent.” The protections cover the provider company, and its employees.

Such agreements, which are typical of the contracts examined by POLITICO, “contain broad protections for intellectual property and related confidentiality and non-disclosure language which can inhibit or discourage reporting of EHR adverse events,” said Elisabeth Belmont, corporate counsel at MaineHealth.

Belmont said she had also seen non-disparagement wordings that prohibit providers from disseminating negative information about the vendor or its software. POLITICO found no direct evidence of such clauses.

"Non-disparagement wording?"

How about good old-fashioned Orwellian thought control?  See my Oct,. 2013 post 'Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As "Advised" At The University Of Arizona Health Network' at http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html.

... The executive branch—the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid Services are responsible for the subsidy program— has done little about the clauses, though providers and researchers have been grumbling about them since the 2011 Institute of Medicine report warning that “[t]hese types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks.”

...Agency officials say they deplore the clauses but lack the capacity to directly address the problem. “We strongly oppose ‘gag clauses’ and other practices that prevent providers and other health IT customers and users from freely discussing problems and other aspects of their health IT,” an ONC spokesman said.

But, he continued, ONC cannot police them. The clauses take a variety of forms, and the extent to which vendors invoke them varies, making enforcement difficult – particularly for a small agency that doesn’t have investigative or police powers.

A small agency that doesn’t have investigative or police powers?  Really?  Yet - ONC is a promoter of the non-regulatory "Safety Center" concept as a solution to health IT safety risks.  See for instance http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.  Their response above to Politico seems disingenuous.

What follows in the Politico article is vendor excuses and soothing reassurances, like this one:

... Epic executives said they encourage open discussion. “With permission, we very frequently allow folks to share information around the software,” said Epic’s vice president for client success, Eric Helsher.

I'll surmise I would not be able to easily get detailed information on the ten thousand EPIC "issues" I highlighted at my Nov. 2013 post "We’ve resolved 6,036 issues and have 3,517 open issues": extolling EPIC EHR Virtues at University of Arizona Health System", http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html, for publication on this blog.

... a lot of problems may go under-reported. That offends [Dr. Bob] Wachter, who says the patient safety world “takes it as religion” that information be shared as widely as possible.

“These are worlds colliding. You can understand why a technology business would put restrictions on screenshots. But we’re not making widgets here, we’re taking care of sick people,” he said.

“At some level, I’d say, ‘How dare they?’”

"At some level?"  What level, exactly?

How about the life-and-death level?

Worlds colliding, indeed; the aforementioned business-IT world and the clinical world.  I would drop the "at some level" phrase, though, and also go back to my 2009 JAMA letter observation that I repeat once again: 

... In their Commentary, Dr Koppel and Mr Kreda made clear the problems associated with applying the customs and traditions of business software contracting and sales (where “hold harmless” and “keep defects secret” clauses are commonplace) to health care information technology (HIT) as if they are the same. I believe that ignoring their differences has likely created an epidemic of violations of hospital governing body responsibilities and Joint Commission standards for health care organization leadership.

Health IT companies are simply not team players in medicine.  Their heavy-handedness and narrow thinking has harmed and killed patients.   How many in total? 

Last year I spoke to a half dozen US House members and a dozen or so aides of House members who could not attend.   I was accompanied by two Plaintiff's lawyers (yes, Plaintiff's lawyers) who told their own tales of EHR-mediated catastrophes whose survivors they had represented.  They were there for that purpose, to inform the US Reps that health IT was killing people.

Extrapolating the ECRI Deep Dive study figures and adding in other known cases, the true level of harms is anything but pretty.

It would be a very useful exercise to measure it explicitly rather than using the Ostrich approach (see for instance my post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html). 

However, obtaining the data in a robust matter could result in those reporting the data violating EHR gag and non-disparagement clauses.

We must respect the rights of the computers...

-- SS

Addendum:  the Politico article, unfortunately, while a major piece, did not cite Koppel/Kreda or their pioneering 2009 JAMA article.  I surmise this was an oversight.

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Increasing Bad Press for Today's Healthcare Information Technology - Deserved and Overdue

forbes health affairs healthcare IT difficulties healthcare IT risks HealthcareDive.com

Increasing Bad Press for Today's Healthcare Information Technology - Deserved and Overdue

Unknown 3/17/2015 Komentar

Here are three candid, quite revealing articles about the distaste for today's health IT that appeared recently.  I will address each,

The first seems like pure deja vu (see my June 4, 2009 post "If The Military Can't Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?" at http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html):

1.  Forbes:  Pentagon's $11 Billion Healthcare Record System Will Be Obsolete Before It's Even Built -  March 3, 2015
http://www.forbes.com/sites/lorenthompson/2015/03/03/military-healthcare-11-billion-record-system-will-be-obsolete-before-its-even-built/

... No doubt about it, the project managers understand how to speak the language of acquisition reform.  However, a close look at what their site proposes to do for the 9.6 million active-duty warfighters and dependents in the military healthcare system reveals that this effort is going to fail.  It will probably be better than what it replaces, but it will lag far, far behind the kind of performance that users of internet-based technologies have come to expect.  So soldiers and sailors and airmen and marines — and their dependents — aren’t going to get the quality of care they deserve, and some will suffer mightily as a result.

In order to understand why the modernization initiative is doomed to failure, you need only grasp the significance of two key phrases the program office uses in its approach to industry for proposals.  First, it says it is seeking a “state-of-the-market” electronic health record system.  Second, it says whatever it selects will be an “off-the-shelf” product.  In other words, it is seeking to acquire an electronic health record system that already exists in an industry noted for its antiquated approach to the movement of information.  Furthermore, despite the program office’s insistence that it will avoid getting locked into reliance on a single monopolistic vendor, the project manager told Politico he envisions the contract as “an extensive prenup and no divorce.”

In other words, what I have described for years as a "business computing" oriented approach to clinical computing - an approach as guaranteed to fail as confusing psychiatry with neurosurgery because they both treat brain disorders, and trying to treat a brain tumor with psychotherapy or a personality disorder with a scalpel.  Specifics matter.

Sounds like vendor lock to me.  The business model the program is pursuing resembles a proprietary enterprise software system of the sort that many major hospitals have installed.

If you don’t know what an enterprise software system is, the first sentence in Wikipedia’s entry on the subject gets to the point: “Enterprise software…is purpose-designed computer software used to satisfy the needs of an organization rather than individual users.”  Got that — rather than individual users?  This approach to information system design is a throwback to the pre-internet days of mainframe computers.  In fact, the dominant version currently in use by private healthcare providers relies on upgrades to software developed nearly half a century ago at the Massachusetts General Hospital.

It's not a throwback to the mainframe era.  It represents the now-obsolete but still dominant, defective control-mentality acculturation and over-empowerment of information technologists (e.g., http://dl.acm.org/citation.cfm?id=563354&coll=portal&dl=ACM).  This acculturation is a remnant not of mainframe days but of the card tabulator data processing era (http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html).

2.  Health Affairs:  Where Is HITECH’s $35 Billion Dollar Investment Going? - March 4, 2015
http://m.healthaffairs.org/blog/2015/03/04/where-is-hitechs-35-billion-dollar-investment-going/

by Sen. John Thune, Sen. Lamar Alexander, Sen. Pat Roberts, Sen. Richard Burr, and Sen. Mike Enzi
 
On April 16, 2013, we released “REBOOT: Re-examining the Strategies Needed to Successfully Adopt Health IT,” outlining concerns with implementation of the Health Information Technology and Economic and Clinical Health (HITECH) Act. Specifically, we asked: What have the American people gotten for their $35 billion dollar investment?

Two years after releasing the white paper, and six years since enactment of the HITECH Act, the question remains. There is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care.

I note that the statement "there is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care" is a euphemistic way of saying "there is conclusive evidence that the program has not achieved its goals of increasing efficiency, reducing costs, and improving the quality of car."

We have been candid about the key reason for the lackluster performance of this stimulus program: the lack of progress toward interoperability. Countless electronic health record vendors, hospital leaders, physicians, researchers, and thought leaders have told us time and again that interoperability is necessary to achieve the promise of a more efficient health system for patients, providers, and taxpayers.

Instead, according to physician surveys, electronic health records (EHRs) are a leading cause of anxiety for physicians across the country. The EHR products are not meaningful to physicians, which is clear when you consider that half of all physicians will have their Medicare payments cut in 2015 for not adopting government benchmarks for EHRs. ... After spending $28 billion so far of the $35 billion total taxpayer investment, significant progress toward interoperability has been elusive.

Sadly, our elected officials still don't quite understand that the largest drawback to today's health IT is not lack of interoperability, but lack of basic operability (usability). 

However, $7 billion of the HITECH $35 billion is still available to waste in order to learn that lesson.

... In listening to the concerns from EHR vendors and EHR users from across the care continuum, ONC has taken an important turn under the leadership of Dr. Karen DeSalvo. The previous ONC leadership did not understand the difficulty and enormity of creating government-approved products in a market that struggled to exist before government incentives arrived.

As a result, our nation’s health care providers are stuck with the huge cost of unwieldy systems trying to conform to government mandates. They are stuck adopting EHR systems which don’t fit into their established workflows. And if they actually want to share their patients’ data, they are stuck with even more costs imposed by vendors.

At the center of all this is the patient who must sit quietly in the exam room looking at her physician use a computer instead of directly talking with her, who likely has seen no better access to her own data, and who is struggling to understand why her doctor has such a difficult time getting her lab results.

This is not exactly an endorsement of ONC's prior leaders.  Perhaps the aforementioned "previous ONC leadership" should have read this blog more carefully.  Or the Wall Street Joutnal where I spelled these outcomes out in 2009.  Emphases mine:

http://www.wsj.com/articles/SB123492035330205101

Feb. 18, 2009

Dear WSJ:

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

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

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

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

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

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

Scot Silverstein, M.D.
Faculty, Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

These were easy predictions to make based on experience and papers such as this.

Finally:

3.  HealthcareDive.com, Has the AMA lost its mojo?  - March 9. 2015
http://www.healthcaredive.com/news/has-the-ama-lost-its-mojo/372532/

As the mainstream media has begun to realize that organized physicians groups are doing all they can to resist adopting EHRs, the coverage of the dispute has revealed just how little impact their efforts—​led by the AMA—​are achieving in accomplishing their goals.

The AMA has come out vehemently against the Meaningful Use program and the high velocity with which the HHS and Congress want doctors to adopt EHRs, and they have written countless letters, position papers and blueprints for reform to announce their displeasure. Moreover, more than 30 other physicians groups have signed on to their copious letters. A recent USA Today piece quoted the incoming chief of the AMA about EHRs.

"Physicians passionately despise their electronic health records," says Lexington, KY, emergency physician Steven Stack, the American Medical Association's president-elect. "We use technology quickly when it works … Electronic health records don't work right now."

A 2013 AMA/RAND study revealed that EHRs are at the root of the modern doctor’s dissatisfaction with his job.

I note that up until relatively recently, the AMA was largely a defender of today's EHR technology.  They certainly got what they wished for...

"Physicians believe in the benefits of electronic health records, and most do not want to go back to paper charts," said Dr. Mark Friedberg, the study's lead author and a natural scientist at RAND, a nonprofit research organization. "But at the same time, they report that electronic systems are deeply problematic in several ways. Physicians are frustrated by systems that force them to do clerical work or distract them from paying close attention to their patients."

In fact, I believe this oft-made statement about "most do not want to go back to paper charts" is incomplete and misleading.  In terms of retrieving data such as labs and images, most probably would not want to go back to paper.  On the other hand, most probably would like to be able to document and enter orders on paper and have clerical personnel transcribe that information into computers - instead of the physicians being the clerical persons themselves, and gratis.

... According to a piece on Wall Street Cheat Sheet, there could be a couple of reasons why the AMA seems to keep getting shut out—​namely the AHA and the Blues.

While the AMA had $19 million to lobby Congress, the American Hospital Association—​which represents providers who took a financial hit after the last ICD-10 adoption delay—​spent $20.75 million last year to lobby lawmakers. Big insurer Blue Cross and Blue Shield, which would also benefit from wide adoption of EHRs and ICD-10, spent $21.3 million in 2014. That's a combined $42 million, more than double the AMA's effort.

Now, factor into that the extreme amount of influence wielded by the tech sector—​Google alone spent $17.5 million in lobbying Congress in 2014—​and the scent in the wind becomes easy to identify. The tech sector stands to make billions from EHR creation and management. Insurers need ICD-10 and EHRs to bring better cost management into their industry, enabling them to spend less as they pay for more care for more patients. Finally, hospitals need the tech because the ACA is bringing millions of new patients into their doors, and the old pegboard and paper systems that doctors are trying to cling to just won't work for hospitals that see tens of thousands of patients each month.

The AMA has set up a showdown on ICD-10 and EHRs that it will lose, and lose big, because it just plain does not carry the muscle it used to.

In other words, medicine has been invaded by the Information Technology industry and the profiteers who stand to benefit from that technology, with the bulk of the work being performed by clinicians, for free and to patient detriment.

This seems a clear formula for clinicians to simply refuse to use health IT altogether for data entry and demand a return to paper data recording with clerical transcription, but alas, it's likely too late for a revolt like that.

As health IT continues to get well-deserved and long-overdue bad press like this, one wonders if our culture will start to recover from the state of health IT delirium it is in.

I am in doubt.

(See my Jan. 20, 2011 post "Healthcare IT delirium" at http://hcrenewal.blogspot.com/2011/01/healthcare-it-delirium.html for more on that issue).

-- SS

3/16/15 Addendum:

A physician actually proposes physicians be paid for clerical work:

Pay doctors and nurses for the time they spend charting
http://www.kevinmd.com/blog/2015/03/pay-doctors-nurses-time-spend-charting.html

-- SS

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An ironically titled session by ECRI Institute: "Would You Bet Your Mother's Life on the Safety of Your EHR?"

ecri institute healthcare IT risks HIMSS Ronni Solomon William Marella

An ironically titled session by ECRI Institute: "Would You Bet Your Mother's Life on the Safety of Your EHR?"

Unknown 3/17/2015 Komentar

An ironically titled session by ECRI Institute "Would You Bet Your Mother's Life on the Safety of Your EHR?" is being held at the annual Health Information Management Systems Society (HIMSS) meeting by Ronni Solomon, JD and William Marella, MBA of the ECRI Institute on April 13, 2015 (http://www.himssconference.org/event.aspx?ItemNumber=36765).

It is announced in the HIMSS press release below in Healthcare IT News.

I should probably be the keynote speaker to that session, as I am suitably qualified to speak of that exact issue.  My mother and I lost such a "bet" (http://hcrenewal.blogspot.com/2013/09/on-ehr-warnings-sure-experts-think-you.html).

It's about time these topics were surfaced, but I still feel there is far too little public awareness of the risks of bad health IT.

http://www.healthcareitnews.com/news/ridding-ehrs-dangerous-often-undetectable-bad-data 
Ridding EHRs of dangerous, often undetectable, bad data

March 13, 2015

As the healthcare industry continues toward its goal of making all patient health records electronically accessible, a health system’s safety increasingly is determined by the quality of its EHR implementation.


Last November ECRI Institute, a non-profit organization that uses scientific methods to test medical products, rated “incorrect or missing data in electronic health records and other health IT systems” as the No. 2 hazard that will put patients at risk in 2015.

“Once inaccurate data gets into the electronic health record, it’s hard to get it out,” said Ronni Solomon, executive vice president and general counsel for ECRI Institute. “That’s a challenge, and the less detectable it is, the higher the risk. You don’t know it’s in there.”

Such incorrect information probably has far more impact than it did on paper, I believe; computer output is often uncritically taken as gospel, and is often cut-and-pasted to newer records without patient interaction, thus propagating an error of omission, commission or data loss or corruption (due to malfunction).

The negative impact of bad data in electronic health records is both immediate and long-lasting. “In the short-run, bad data in the system limits the effectiveness of clinical communications and the effectiveness of decision support,” added William Marella, ECRI’s executive director, PSO operations and analytics. “And basically it undermines people’s confidence in the system.”

Especially the clinicians' confidence, which is already low (e.g., see my Jan. 28, 2015 post "Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html).

Solomon and Marella will conduct an educational session at HIMSS15 in April on how healthcare organizations can apply safety science to IT and informatics to improve patient safety.

The first step they can take is to strip control of critical health IT decisions from the business-IT personnel and put heath IT under the aegis of medical leadership, especially medical leadership that contains formally-educated Medical Informatics and related professionals.  (This admittedly and unfortunately has a very low chance of happening due to hospital politics and power structures.)

“Would You Bet Your Mother's Life on the Safety of Your EHR?” is designed to help attendees create a framework for planning and implementing IT strategies, processes and tools to increase the safety of healthcare patients.

Both Ms. Solomon and Mr. Marella are aware of what happened to my mother.  I wonder out loud if the title is based on, at least in part, that incident.

... “The promise of these systems is that they’re going to make the health care system more efficient and ultimately more safe,” Marella said. “Now the administrators in hospitals and health systems that have financed these systems want a return on their investment.”

Perhaps the administrators should have done due diligence on the realities of this technology before investing the money.

The session will cover how organizations can: establish an infrastructure for identifying and responding to patient safety problems; assess safety challenges facing health IT users and implementers; identify partnerships that can accelerate safety improvements; and analyze opportunities to use informatics to prevent adverse events.


“What we’re trying to do in this talk is get in front of the IT leaders of these institutions and help them understand where patient safety people are coming from and how we can bridge these two silos within the health system, because they will both be more effective working together,” Marella said.

I add that all of these goals should have been met prior to a national rollout and, at each organization, prior to subjecting patients to these technologies, but I speak common sense, which in medicine is no longer common.  Thus, sessions like this one in 2015.

Perhaps this could be the theme poster for the session.

-- SS

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