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

Opinion, CIO Magazine: "The medical profession needs to get over its fear of information technology"- their complaints bogus

There comes a time when the pundits defending the status quo in the healthcare information technology sector and health IT utopianism simply need to be thoroughly and definitively refuted.

This is such a time.  CIO magazine reaches the country's information technology leadership, including those in heathcare.   Hence, canards and meritless defamation of physicians can (and in my experience does) impact the attitudes and decisions of the leaders of the very technology physicians are increasingly dependent upon to deliver safe care.

Ultimately, such misinformation can and does result in patient harm through bad health IT.

Let's start with the title and subtitle alone of an opinion piece in CIO magazine:

March 26, 2015 
Paddy Padmanabhan - Opinion
http://www.cio.com/article/2886751/healthcare/the-medical-profession-needs-to-get-over-its-fear-of-information-technology.html 

The medical profession needs to get over its fear of information technology
Continued objections to Electronic Health Records ( EHR) by sections of the physician community are bogus. They arise from past entitlements and a lack of accountability.

The term "bogus" has clear meaning:

Merriam-Webster dictionary
http://www.merriam-webster.com/dictionary/bogus
Bogus

:  not genuine :  counterfeit, sham

This is a laughable yet alarming, cavalier defamation and attempted character assassination of the medical profession.

Mr. Padmanabhan is described as a business leader & entrepreneur with over 25 years of experience in Technology and Analytics in the Healthcare sector as well as being a consultant in that domain.  I can openly aver that, with an apparent significant bias as seen below towards the medical profession, I would not want him involved in any way in my own care...

There is nothing "bogus" about, for instance,

• The complaints of nearly 40 medical societies ("Meaningful Use Not so Meaningful", http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html), 

• Countless nurses ("Nurses Warn That Serious Patient Complications 'Only a Matter of Time' in Open Letter", http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html and "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" at http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html; there are links there to still more examples),

• Organizations studying health IT including the U.S. National Academies ("Current Approaches to U.S. Health Care Information Technology are Insufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause"), http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572), 

• Institute of Medicine ("Health IT and Patient Safety: Building Safer Systems for Better Care", http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html), 

• ECRI Institute (Deep Dive Study on Health IT Safety, http://www.healthit.gov/facas/sites/faca/files/STF_Deep_Dive_Health_Information_Technology_2014-06-13.pdf) 

• and others as memorialized on this blog (e.g., http://hcrenewal.blogspot.com/search/label/EHR%20death, also http://hcrenewal.blogspot.com/search/label/glitch) and elsewhere.

The author risibly dismisses them all with the word "bogus."  It might be opined that he was too indolent to conduct research, but I'll just opine he doesn't know what he doesn't know and that the opinion piece was based on simple ignorant arrogance.

I am uncertain what "entitlements" he refers to, but using paper records was not a physician "entitlement" - in fact, they are still used when the lousy hospital IT decides to go on vacation as it recently did, for example, at Children's Hospital Boston ("Boston Children’s emerges from electronic records shutdown", Boston Globe, March 25, 2015,  http://www.bostonglobe.com/metro/2015/03/25/boston-children-emerges-from-day-shutdown-electronic-medical-records/Q6sE7hRM4CxFeMEDYWP8IK/story.html#). 

(Of course, patient safety was not compromised - it never is when the IT goes out - right.  See the many posts at the query link http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised.)

Further, the true "lack of accountability" lies with the healthcare IT industry itself and the hospital leadership who agree to their terms of contractual indemnification (Health care information technology vendors' "hold harmless" clause: implications for patients and clinicians. Koppel & Kreda, JAMA. 2009 Mar 25;301(12):1276-8. doi: 10.1001/jama.2009.398, http://medecon.pbworks.com/f/IT%20Accountability%20JAMA09.pdf. 

Also see my commentary in a JAMA letter to the editor of July 2009 at http://jama.jamanetwork.com/article.aspx?articleid=184302 emphasizing how these arrangements violate Joint Commission safety standards, and my posting my health IT academic site at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda).

And that was just responding to the title and subtitle.  Now to the body of the piece:

... In a recent article in a national publication, a member of our physician community raked up a debate by declaring the Electronic Health Records (EHR ) mandate to be a debacle and argued that EHR’s actually harm patients.  These are bogus objections.

Congratulations for disrespecting my mother's grave, Mr. Padmanabhan (http://hcrenewal.blogspot.com/2013/09/on-ehr-warnings-sure-experts-think-you.html)  and that of many other people harmed by Information Technology Malpractice as for example in the above links

Also see "The Malpractice Risk of Electronic Health Records", Legal Intelligencer - a Pennsylvania Legal newspaper, March 17, 2015, http://www.thelegalintelligencer.com/most-read-articles/id=1202720405290/The-Malpractice-Risk-of-Electronic-Health-Records.

Thanks for being an expert on the issues you so glibly dismiss, Mr. Padmanabhan.  I guess you forgot to check out the AHRQ hazards taxonomy (http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf) and similar resources on health IT risk:

A "bogus" checklist of known EHR risks from the U.S. government.  Click to enlarge.

Back to the opinion piece:

... According to a Rand Corporation study, the three key objections against the implementation of EHR’s:

--It costs too much to implement an EHR system: Yes, it costs money to implement any new software. Given a choice, physicians would prefer not to use email or even the telephone because all of these things cost money and have no direct relation to the treatment of patients. What these same physicians also fail to mention is that large hospital systems have been extending significant subsidies to small physician practices in order to help them address the costs.

"Given a choice, physicians would prefer not to use email or even the telephone because all of these things cost money and have no direct relation to the treatment of patients." (?)


Really?

This is an example of a profound anti-physician bias, although one could argue that the term mentioned by Yves Smith on Naked Capitalism, "lunatic triumphalism", comes into play with that statement.

What these same physicians also fail to mention is that large hospital systems have been extending significant subsidies to small physician practices in order to help them address the costs.

And just what % of the total costs of ownership are covered, Mr. Padmanabhan?   The financial analyses I see show significant clinician unreimbursed expense for the office.

Inpatient settings - that's another matter entirely - we're talking hundreds of millions of dollars or more per organization.

Perhaps my math is wrong, but hundreds of millions of dollars hospitals dish out on corporate health IT can pay for entire new hospitals, or pay for the medical care of countless disadvantaged people.  (e.g., http://hcrenewal.blogspot.com/2014/06/100-million-epic-install-dampens.html, as well as http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html and http://hcrenewal.blogspot.com/2013/06/want-to-help-hospital-go-bankrupt-get.html)

--It takes time away from patient care: Physicians love to talk about how much they care about being with their patients. However, they also routinely overbook their schedules with the sole intention of increasing patient visits and claiming additional reimbursement.

That's a very serious and, to my knowledge, completely unfounded accusation.  Many physicians are burned out from being compelled to see too many patients by administrators, especially if they are employed which is becoming very common. You in my opinion need to be taught how not to hate physicians and other clinicians, Mr. Padmanabhan:

Physician Burnout: It Just Keeps Getting Worse
Medscape, Jan, 26, 2015
http://www.medscape.com/viewarticle/838437

A national survey published in the Archives of Internal Medicine in 2012 reported that US physicians suffer more burnout than other American workers.[1] This year, in the Medscape Physician Lifestyle Report, 46% of all physicians responded that they had burnout, which is a substantial increase since the Medscape 2013 Lifestyle Report, in which burnout was reported in slightly under 40% of respondents. Burnout is commonly defined as loss of enthusiasm for work, feelings of cynicism, and a low sense of personal accomplishment

Back to the opinion piece:

EHR’s can actually aid their productivity by reducing the time it takes to pull up medical history, so that they have more time to spend on actually talking to their patients.

An expert with far more experience than you, Mr. Padmanabhan, says you are flat wrong (not counting me).  His name is Dr. Clement McDonald, and he is an EHR pioneer ("The Tragedy Of Electronic Medical Records", http://hcrenewal.blogspot.com/2014/10/the-tragedy-of-electronic-medical.html):

... McDonald now has a nationally influential post to promote electronic medical records, as the director of the Lister Hill Center for Biomedical Communications, a part of the National Library of Medicine, which is one of the National Institutes of Health.

During his talk, McDonald released his latest research survey, which found that electronic medical records “steal” 48 minutes per day in free time from primary care physicians.

Back to the opinion of Mr P.:

--EHR systems are hard to use and are not secure: There may be some merit to this. No one is making claims that EHR systems are perfect.

"May be some merit?"

"May?"


There is perhaps merit to saying Mr. Padmanabhan is either ill-informed, or delivering deliberate misinformation  (e.g., "NIST on the EHR Mission Hostile User Experience", http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html, and multiple posts on breach issues retrievable via query link http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy).

However, there are a few key aspects that these physicians prefer to not acknowledge when making these arguments:

--Shared electronic medical records can reduce expenses: Physicians routinely bill for duplicate medical expenses, such as tests, that would be avoided if the test results can simply be pulled up electronically. This should logically reduce healthcare costs at a system level.

Great in theory, but the real world is just not that simple.  Mr. Padmanabhan like many other IT hyper-enthusiasts apparently see IT as a silver bullet.  Just put it in and .... presto!  All complex multi-factorial social problems are solved, with no ill effects. Perhaps he and other hyper-enthusiastic health IT pundits need to read this article:

Pessimism, Computer Failure, and Information Systems Development in the Public Sector.  (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).  Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.  linkto pdf

And this:

"Doctors and EHRs: Reframing the "Modernists v. Luddites" Canard to The Accurate "Ardent Technophiles vs. Pragmatists" Reality", http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html

More opinion:

--Quality of treatment can improve significantly: When a complete medical record is available about a patient, including details of visits to multiple healthcare professionals, the quality of diagnosis and hence treatment decisions should improve greatly. This improves patient safety and reduces medical errors, since everyone has access to the same set of data.

 That may be the only accurate statement in the opinion piece.  Yet, even this is not proven in the real world, and with today's highly experimental health IT.

--EHR’s can enable preventive diagnosis and early intervention that reduces costs and improves patient health: Enter healthcare analytics. Having patient medical records in an electronic system enables this data to be analyzed for preventive and early action, improved disease management, and reduced hospitalizations. The whole notion of population health management rests on this premise and is hard to argue with.

It's actually easy to argue with, as are most grandiose pronouncements about computational alchemy (i.e., in the world of data, turning lead into gold).

Again in theory, yes, but Mr. Padmanabhan is seemingly unaware of issues I raised in my article "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?" at http://www.jpands.org/vol14no2/silverstein.pdf.  The uncontrolled nature of aggregated EHR data, and social factors that skew and bias it, never seem to enter into the minds of the computational alchemists.

The truth is:

• Physicians, nurses and other clinicians are rightfully afraid of having bad health IT forced upon them due to the constraints of their time, their concentration, and their obligations and legal liabilities; 

• Physicians are rightfully unwilling to be the experimental subjects of IT hyper-enthusiasts who are so hooked on theory, they ignore the actual downsides of an immature, experimental technology in the real world, including patient injury and death; and

• Patients should be scared to death of this technology as it now exists in the real world - and should also object to being experimental subjects for life-critical software debugging (e.g., see "We’ve resolved 6,036 issues and have 3,517 open issues" (http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html), especially without informed consent of the risks.

I note that I feel dirtied even having to write this post.

-- SS

Addendum 3/27/15:  

A colleague observed:

.. And I suppose all those current med students and residents who grew up with information technology and have known nothing but  EHR’s are “afraid” of information technology?  I’m hearing complaints from the younger generation about the problems with using them. 

-- SS

1:47 PM

Wall Street Journal: "ObamaCare’s Electronic-Records Debacle"

This WSJ Op-Ed could have been entitled "President Sucker:  Led Down the Garden Path by The Healthcare IT Industry."

It is entitled "ObamaCare’s Electronic-Records Debacle", as below.  First, though:

On Feb. 18, 2009 the WSJ published the following Letter to the Editor authored by me (http://www.wsj.com/articles/SB123492035330205101):

Digitizing Medical Records May Help, but It's Complex

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

The UK's National Programme for Health IT in the NHS (NPfIT) has since died. (See my Sept. 22, 2011 post "NPfIT Programme goes PfffT" at http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html.)  Also see my Dec. 7, 2008 post "Open Letter to President Barack Obama on Healthcare Information Technology" warning of many issues at http://hcrenewal.blogspot.com/2008/12/open-letter-to-president-barack-obama.html.

Now, the WSJ, to which I and other colleagues have been speaking about the realities of healthcare information technology for years but which has seemed reluctant to publish what would amount to a stinging corporate rebuke, has published this Op-Ed by a surgeon, Jeffrey A. Singer:

http://www.wsj.com/articles/jeffrey-a-singer-obamacares-electronic-records-debacle-1424133213

ObamaCare’s Electronic-Records Debacle
The rule raises health-care costs even as it means doctors see fewer patients while providing worse care.

By Jeffrey A. Singer
Feb. 16, 2015 7:33 p.m. ET

The debate over ObamaCare has obscured another important example of government meddling in medicine. Starting this year, physicians like myself who treat Medicare patients must adopt electronic health records, known as EHRs, which are digital versions of a patient’s paper charts. If doctors do not comply, our reimbursement rates will be cut by 1%, rising to a maximum of 5% by the end of the decade.

I am an unwilling participant in this program. In my experience, EHRs harm patients more than they help.

I note that it's not just physicians who are unwilling participants in this medical experiment.  We all are - as patients - in this unregulated experiment. 

As a colleague puts it, with an addendum by me:

"Why are we implementing patient care tools that are not tested for harms, not evaluated for harms, not reported systematically for harms, while the government does not refute the statement that harms are caused by EHRs and admits the true magnitude of harms is unknown?"

The program was inspired by the record-keeping models used by integrated health systems, especially those of the nonprofit consortium Kaiser Permanente and the Department of Veterans Affairs.

Yet even in those environments, these systems cause major problems, e.g.,

http://www.modernhealthcare.com/article/20140620/NEWS/306209940
Complicated, confusing EHRs pose serious patient safety threats [at VA]

By Sabriya Rice
Posted: June 20, 2014 - 8:15 pm ET

Confusing displays, improperly configured software, upgrade glitches and systems failing to speak to one another—those are just a few electronic health record-related events that put patients in danger, according to a new study.

The more complex an EHR system, the more difficult it may be to trace problems, patient safety experts warn. Hospitals planning to add new software or make updates should be strategic about changes and proactively include ways to monitor events.

“Because EHR-related safety concerns have complex socio-technical origins, institutions with longstanding, as well as recent EHR implementations, should build a robust infrastructure to monitor and learn from them,” concluded the report published Friday in the Journal of the American Medical Informatics Association.

Researchers evaluated 100 closed safety investigations reported between August 2009 and May 2013 to the Informatics Patient Safety Office of the Veterans Health Administration.

Among the findings, 74 events resulted from unsafe technology, such as system failures, computer glitches, false alarms or “hidden dependencies,” a term for what happens when a change in one part of a system inadvertently leads to key changes in another part. Another 25 events involved unsafe use of technology such as an input error or a misinterpretation of a display.

The authors of that study admitted the data was very incomplete due to limitations of error recognition, data collection and diffusion, and other factors.

Back to the WSJ:

The federal government mandated in the 2009 stimulus bill that all medical providers that accept Medicare adopt the records by 2015. Bureaucrats and politicians argued that EHRs would facilitate “evidence-based medicine,” thereby improving the quality of care for patients.

This is the "silver bullet theory of IT-enabled transformation" at work.  Add computers and - Presto!  Better care!  After all, how hard can it be to get to the moon in a hot air balloon? 

The moon is "up" and balloons go "up", therefore, why not? All that's required are the right "processes" -- with which the Acme Hot Air Balloon Co. executives can accomplish anything -- and ignoring those pessimistic scientists, engineers and other experts who speak of vacuum of space and radiation and all those esoteric "gotchas" that are bad for business! (See my 2008 Powerpoint presentation to the IEEE Medical Technology Policy Committee on these issues entitled "To The Moon In A Hot Air Balloon: Why Is Clinical IT Difficult?" at this link.)

But for all the talk of “evidence-based medicine,” the federal government barely bothered to study electronic health records before nationalizing the program. The Department of Health and Human Services initiated a five-year pilot program in 2008 to encourage physicians in 12 cities and states to use electronic health records. One year later, the stimulus required EHRs nationwide. By moving forward without sufficient evidence, lawmakers ignored the possibility that what worked for Kaiser or the VA might not work as well for Dr. Jones.

Not only that, the government and industry are hell-bent on avoiding any meaningful quality regulation (see my April 9, 2014 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).

Even more critically, they didn't bother to seriously study harms.  Leave that to the independent ECRI Institute, whose findings were alarming (see http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).  The ECRI Institute has not followed up on this study that I am aware; being recipients of government money, as I understand it, to study the problems may have impaired their independence and softened their tone.)

Which is exactly what is happening today. Electronic health records are contributing to two major problems: lower quality of care and higher costs.

The former is evident in the attention-dividing nature of electronic health records. They force me to physically turn my attention away from patients and toward a computer screen—a shift from individual care to IT compliance. This is more than a mere nuisance; it is an impediment to providing personal medical attention.

As someone who formally entered the field in 1992 via postdoc in Medical Informatics at Yale School of Medicine, I can state emphatically that the whole concept of direct physician data entry was an experiment.  In medical informatics, we were exploring ways to avoid the known detriments of direct physician entry via creative applications of information technology.

That experiment has been a clear failure, at least as diffused into the commercial health IT sector in 2015.  However few in my field are willing to admit this due to, in large part, avoidance of dealing with the unpleasant consequences of that admission.  (One pioneer, Clement McDonald now at NIH, has admitted this.  See my Oct. 29, 2014 post "The tragedy of electronic medical records" (http://hcrenewal.blogspot.com/2014/10/the-tragedy-of-electronic-medical.html.)

Doctors now regularly field patient complaints about this unfortunate reality. The problem is so widespread that the American Medical Association—a prominent supporter of the electronic-health-record program—felt compelled to defend EHRs in a 2013 report [now supplanted - see below - ed.], implying that any negative experiences were the fault of bedside manner rather than the program.

AMA has changed its tone.

I think the author of this Op-Ed may have missed the Jan. 21, 2015 letter to HHS from multiple medical societies or submitted this Op-Ed prior to that date. 

A group of 37 medical societies led by the American Medical Association sent a letter to Health and Human Services last month saying the certification program is headed in the wrong direction, and that today's electronic records systems are cumbersome, decrease efficiency and, most importantly, can present safety problems for patients. 

I covered that Jan. 21, 2015 letter at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html. 

Apparently our poor bedside manner is a national crisis, judging by how my fellow physicians feel about the EHR program. A 2014 survey by the industry group Medical Economics discovered that 67% of doctors are “dissatisfied with [EHR] functionality.” Three of four physicians said electronic health records “do not save them time,” according to Deloitte. Doctors reported spending—or more accurately, wasting—an average of 48 minutes each day dealing with this system.

Nurses are having similar experiences.  I've written previously about substantial problems nurses at Affinity Medical Center, Ohio (http://www.affinitymedicalcenter.com/) and other organizations are having with EHRs, and how hospital executives were ignoring their complaints.  The complaints have been made openly, I believe, in large part due to the protection afforded by nurses' unions.

See for example my July 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" at http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html (there are links there to still more examples), and my June 2013 post  "Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday" at http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html, along with links therein to other similar situations.

Particularly see my July 2013 post "How's this for patient rights? Affinity Medical Center manager: file a safety complaint, and I'll plaster it to your head!" at http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html, where a judge had to intervene in a situation of apparent employee harassment for complaints about patient safety risks.  Also see my post about an open letter to the Chief Nursing Officer (CNO) dated August 15, 2013, at http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html.

That plays into the issue of higher costs. The Deloitte survey also found that three of four physicians think electronic health records “increase costs.” There are three reasons. First, physicians can no longer see as many patients as they once did. Doctors must then charge higher prices for the fewer patients they see. This is also true for EHRs’ high implementation costs—the second culprit. A November report from the Agency for Healthcare Research and Quality found that the average five-physician primary-care practice would spend $162,000 to implement the system, followed by $85,000 in first-year maintenance costs. Like any business, physicians pass these costs along to their customers—patients.

Then there’s the third cause: Small private practices often find it difficult to pay such sums, so they increasingly turn to hospitals for relief. In recent years, hospitals have purchased swaths of independent and physician-owned practices, which accounted for two-thirds of medical practices a decade ago but only half today. Two studies in the Journal of the American Medical Association and one in Health Affairs published in 2014 found that, in the words of the latter, this “vertical integration” leads to “higher hospital prices and spending.”

I do not enjoy the fact that this occurred to my own personal physicians who are now employees of a hospital against which I am substitute plaintiff for my deceased mother, whose injuries were EHR-related.  See "On EHR Warnings: Sure, The Experts Think You Shouldn't Ride A Bicycle Into The Eye Of A Hurricane, But We Have Our Own Theory" at
http://hcrenewal.blogspot.com/2013/09/on-ehr-warnings-sure-experts-think-you.html, actually penned in 2011.

Proponents of electronic health records nonetheless claim that EHRs decrease record-keeping errors and increase efficiency. My own experience again indicates otherwise and is corroborated by research.

The EHR system assumes that the patient in front of me is the “average patient.” When I’m in the treatment room, I must fill out a template to demonstrate to the federal government that I made “meaningful use” of the system. This rigidity inhibits my ability to tailor my questions and treatment to my patient’s actual medical needs. It promotes tunnel vision in which physicians become so focused on complying with the EHR work sheet that they surrender a degree of critical thinking and medical investigation.

"Critical thinking always, or your patient's dead" - Victor P. Satinsky MD, heart surgery pioneer, Hahenemann Hospital.

Distractions to the doctor-patient interaction are unwelcome and damn well better have a very high payback - which the experiment with health IT is showing is simply not there at the stage of development of this commercial technology in 2015.

Not surprisingly, a recent study in Perspectives in Health Information Management found that electronic health records encourage errors that can “endanger patient safety or decrease the quality of care.” America saw a real-life example during the recent Ebola crisis, when “patient zero” in Dallas, Thomas Eric Duncan, received a delayed diagnosis due in part to problems with EHRs.

That event could have led to catastrophe, but such errors are daily occurrences in hospitals all across the country.  See the many posts on this blog of EHR risks under the index link http://hcrenewal.blogspot.com/search/label/glitch.

Congress has devoted scant attention to this issue, instead focusing on the larger ObamaCare debate. But ending the mandatory electronic-health-record program should be a plank in the Republican Party’s health-care agenda. For all the good intentions of the politicians who passed them, electronic health records have harmed my practice and my patients.

Dr. Singer practices general surgery in Phoenix and is an adjunct scholar at the Cato Institute.

I would change that to "... ending the mandatory electronic-health-record program should be a plank in the government's health-care agenda."

Finally, of the author's adjunct affiliation, it seems bad health IT affects physicians all across the political spectrum.

-- SS

11:33 AM

What in God's Name is Going on With Healthcare IT at Cambridge University Hospitals?

This story about a  UK hospital that recently "went live"with an American electronic health record/enterprise command-and-control system (EPIC) was not only predictable, but expected considering the sorry state of the health IT industry in terms of clinical leadership and regulation.

(It appears this was a "big bang" rollout, see http://www.ehi.co.uk/news/EHI/8845/cambridge-goes-for-epic-big-bang, an implementation method better suited for warehouses and widget suppliers than major hospitals.)

Addenbrooke’s staff blame blood shortage on new eHospital
By CambridgeNews  |  Posted: November 05, 2014
http://www.cambridge-news.co.uk/Addenbrooke-8217-s-staff-blame-blood-shortage-new/story-24513716-detail/story.html

By Freya Leng

Members of staff at Addenbrooke's [hospital, http://www.cuh.org.uk/addenbrookes-hospital] have voiced their concerns about the new IT system which has been blamed for a blood shortage.

Cambridge University Hospitals' eHospital went live on October 26 and is designed to improve the quality of care for patients by allowing clinicians and frontline staff to access patient information wherever they are, at the click of a button.

I must put to rest this lie once again.  The unregulated, generally terrible software being sold by the so-called EHR vendors is NOT simply software to allow clinicians to  "access patient information wherever they are."  

This is enterprise clinician and clinical resource command-and-control software, through which increasingly each transaction related to care must pass.  In other words, ERP packages to manage patient care, as one might manage inventory and shipping in a merchant enterprise:

http://en.wikipedia.org/wiki/Enterprise_resource_planning

Enterprise resource planning (ERP) is a business management software—usually a suite of integrated applications—that a company can use to collect, store, manage and interpret data from many business activities

Unfortunately, the reductionist assumptions behind the conception, design, authoring and implementation of such ERP software - that hospitals and healthcare are linear, predictable processes - are both deadly wrong, and the beliefs of fools and the recklessly cavalier.

To wit:

But since the launch, the News has been contacted by a senior member of staff at Addenbrooke's who said the new IT system was having "serious consequences" on the "operational running of the service".

In a letter, the staff member who does not want to be named [due to potential for retaliation - ed.], said: "The hospital has very little blood available due to transfusion lab technical failures. Truth - the new IT system is responsible."

The letter also states the impact the shortage of blood has had on the hospital including the cancellation of all elective surgery until November 8 as well as impacting on any procedure that holds a risk of blood transfusion and organ transplantation.

"I believe sufficient risk has been placed upon all patients under care of Addenbrooke's," the staff member said. "Someone needs to be responsible for the implementation of the new IT system."

In my experience, the non-clinical executives who often select this technology, and the IT personnel who then implement the technology (often ignoring clinicians), do need to be held responsible for bad outcomes - in the courtroom.

The News also understands the whole system went down for six hours at the weekend with staff reverting back to paper and all major trauma cases diverted elsewhere.

There are numerous cases on this blog of disruptive and patient-endangering EHR system outages.  These are simply inexcusable regarding life-critical computing. The unexpected transitions back and forth between paper endanger patients.

A doctor, who also did not want to be named, said the wifi system which supports all the ward rounds is "unfit for purpose" and is leading to gross inefficiency.

If this is true, it once again represents the cavalier nature of those technologists rarely held accountable for mistakes that, of they occurred in other critical industries (e.g., aviation, nuclear energy) might leave smoldering ruins and radioactive clouds that would result in the end of their careers...at the very least.  Unfortunately, individual injured and dead patients are not quite as visible to the public.

"The general feeling on the ground is that they could not have implemented the system any worse than they have done and without any doubt it has already significantly affected patient care." they said.

This is consistent with my own personal experience with hospital IT departments in the U.S., where mistakes that I could not even have conceived of making, were regularly made - leaving me to have to point out and clean up the mess, at risk to my own career due to the reactions of the non-clinical IT leaders and staff to being shown their own inadequacy regarding clinical affairs.  (This was, of course, an odd reaction by people who'd never gone to medical school, let alone had doctoral or postdoctoral study, research and development experience in Medical Informatics.)

A CUH spokesman said: "eHospital gives our staff more time with patients at the bedside, many of whom are frail, elderly and have complex conditions.

Right, just those patients who are most vulnerable to IT debacles and the cascading errors that can result.

"However, unlike banks, shops or travel agents, we cannot close our doors or stop our services to the hundreds of thousands of people we treat every year. So it was always going to be a challenge to implement such a massive change.

That is a very poor excuse for IT malpractice.  It makes the reader believe everything possible in due diligence was done, that others' experience was completely paid attention to, etc.  The results give me great doubt about that...

"Pathology was affected early last week, which led to a brief reduction in the number of tests, but we are increasingly operating as normal. We did carry out a successful 're-boot' of the system early on Sunday morning.

There we go once again  the typical bureaucratic spin that "the malfunctions were minor, nothing to see here, move along, patient safety was not compromised"  (a recurrent refrain with its own index term on this blog, see the 25+ posts at http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised) - while at the same time these systems are represented as revolutionizing medicine - except when they malfunction, at which time they have no meaningful effects on care.

"The much bigger challenge we face is that the Trust is incredibly busy and we have limited numbers of beds available, and which need to be kept free for emergency cases. Operations will continue to be rescheduled until the community care for those who no longer need a hospital bed is in place. We do sympathise with the frustration that people feel and apologise for the delay they are experiencing."

In my opinion, patients put at risk, and injured and dead patients need and deserve more than apologies for information technology malpractice.

Especially at Cambridge University, where in my opinion, this whole affair is truly a world-class embarrassment.

-- SS

11:51 AM

Computer Viruses Are "Rampant" on Medical Devices in Hospitals

As if there weren't enough problems with hospitals as computing backwaters, now there's this:

Computer Viruses Are "Rampant" on Medical Devices in Hospitals

A meeting of government officials reveals that medical equipment is becoming riddled with malware.

Technology Review
Published by MIT
David Talbot
Wednesday, October 17, 2012

Computerized hospital equipment is increasingly vulnerable to malware infections, according to participants in a recent government panel. These infections can clog patient-monitoring equipment and other software systems, at times rendering the devices temporarily inoperable.

While no injuries have been reported, the malware problem at hospitals is clearly rising nationwide, says Kevin Fu, a leading expert on medical-device security and a computer scientist at the University of Michigan and the University of Massachusetts, Amherst, who took part in the panel discussion.

I note the seemingly universal refrain "no injuries have been reported" once more (see this query link to similar statements regarding IT malfunctions), which is irrelevant since reporting mechanisms for medical errors are noted to be deficient.

Software-controlled medical equipment has become increasingly interconnected in recent years, and many systems run on variants of Windows, a common target for hackers elsewhere. The devices are usually connected to an internal network that is itself connected to the Internet, and they are also vulnerable to infections from laptops or other device brought into hospitals.  [I note that it should be impermissible to connect "alien" machines to a hospital's network without authorization, and that attaining that level of security protection is not difficult - ed.]  The problem is exacerbated by the fact that manufacturers often will not allow their equipment to be modified, even to add security features.

In a typical example, at Beth Israel Deaconess Medical Center in Boston, 664 pieces of medical equipment are running on older Windows operating systems that manufactures will not modify or allow the hospital to change—even to add antivirus software—because of disagreements over whether modifications could run afoul of U.S. Food and Drug Administration regulatory reviews, Fu says.

In other words, let's run at high risk if it avoids the time and expense of FDA reviews that would ensure the equipment is safe and operates as expected with the software updates.

As a result, these computers are frequently infected with malware, and one or two have to be taken offline each week for cleaning, says Mark Olson, chief information security officer at Beth Israel.

It is unclear how the servers running the hospital information system, electronic health records systems, physician order entry systems etc. are immune to spread of the malware.

"I find this mind-boggling," Fu says. "Conventional malware is rampant in hospitals because of medical devices using unpatched operating systems. There's little recourse for hospitals when a manufacturer refuses to allow OS updates or security patches."

The worries over possible consequences for patients were described last Thursday at a meeting of a medical-device panel at the National Institute of Standards and Technology Information Security and Privacy Advisory Board, of which Fu is a member, in Washington, D.C. At the meeting, Olson described how malware at one point slowed down fetal monitors used on women with high-risk pregnancies being treated in intensive-care wards.

In its face, that is potentially catastrophic depending on the degree of "slowdown" and whether data is lost.

"It's not unusual for those devices, for reasons we don't fully understand, to become compromised to the point where they can't record and track the data," Olson said during the meeting, referring to high-risk pregnancy monitors. "Fortunately, we have a fallback model because they are high-risk [patients]. They are in an IC unit—there's someone physically there to watch. But if they are stepping away to another patient, there is a window of time for things to go in the wrong direction."

The reasons seem obvious to anyone who's had a serious malware infection on their PC.  I've only had one - a computer I bought at a fleamarket for $7 was so severely infected it was unusable for even basic tasks, and was resistant to virus removal.  I solved that problem by installing a fresh copy of the OS, immediately followed by all patches and the latest anti-malware software.

The computer systems at fault in the monitors were replaced several months ago by the manufacturer, Philips; the new systems, based on Windows XP, have better protections and the problem has been solved, Olson said in a subsequent interview.

This implies the older systems were running on Win 98 or earlier or an old version of Win NT.  Amazing.

At the meeting, Olson also said similar problems threatened a wide variety of devices, ranging from compounders, which prepare intravenous drugs and intravenous nutrition, to picture-archiving systems associated with diagnostic equipment, including massive $500,000 magnetic resonance imaging devices.

Olson told the panel that infections have stricken many kinds of equipment, raising fears that someday a patient could be harmed. "We also worry about situations where blood gas analyzers, compounders, radiology equipment, nuclear-medical delivery systems, could become compromised to where they can't be used, or they become compromised to the point where their values are adjusted without the software knowing," he said. He explained that when a machine becomes clogged with malware, it could in theory "miss a couple of readings off of a sensor [and] erroneously report a value, which now can cause harm."

I opine that harm could already have occurred; it just may not been recognized as such nor reported.  Disappearing data and other EHR failure modes known to have caused harm and/or deaths could be related to malware, for example.

... Malware problems on hospital devices are rarely reported to state or federal regulators, both Olson and Fu said. This is partly because hospitals believe they have little recourse. Despite FDA guidance issued in 2009 to hospitals and manufacturers—encouraging them to work together and stressing that eliminating security risks does not always require regulatory review—many manufacturers interpret the fine print in other ways and don't offer updates, Fu says. And such reporting is not required unless a patient is harmed. "Maybe that's a failing on our part, that we aren't trying to raise the visibility of the threat," Olson said. "But I think we all feel the threat gets higher and higher."

I note that health IT related problems are also rarely reported, with only one vendor being the exception (see my post on the FDA MAUDE voluntary reporting database here).  The reasons likely are not because "hospitals believe they have little recourse" - the real reasons may be fear, complacency and/or incompetence.

Speaking at the meeting, Brian Fitzgerald, an FDA deputy director, said that in visiting hospitals around the nation, he has found Beth Israel's problems to be widely shared. "This is a very common profile," he said. The FDA is now reviewing its regulatory stance on software, Fitzgerald told the panel. "This will have to be a gradual process, because it involves changing the culture, changing the technology, bringing in new staff, and making a systematic approach to this," he said.

Changing the culture would be nice, considering we are now entering a national rollout of complex enterprise clinical resource and workflow control systems anachronistically known as "electronic medical records."

In an interview Monday, Tam Woodrum, a software executive at the device maker GE Healthcare, said manufacturers are in a tough spot, and the problems are amplified as hospitals expect more and more interconnectedness. He added that despite the FDA's 2009 guidance, regulations make system changes difficult to accomplish: "In order to go back and update the OS, with updated software to run on the next version, it's an onerous regulatory process."

My comment is, if you can't take the heat of work in the real-world medical setting, if you cannot be part of the medical team, then get out of the clinic.  You're likely to do more harm than good.

John Halamka, Beth Israel's CIO and a Harvard Medical School professor, said he began asking manufacturers for help in isolating their devices from the networks after trouble arose in 2009: the Conficker worm caused problems with a Philips obstetrical care workstation, a GE radiology workstation, and nuclear medical applications that "could not be patched due to [regulatory] restrictions." He said, "No one was harmed, but we had to shut down the systems, clean them, and then isolate them from the Internet/local network."

He added: "Many CTOs [chief technology officers - ed.] are not aware of how to protect their own products with restrictive firewalls. All said they are working to improve security but have not yet produced the necessary enhancements."

Then why are they CTO's?  Is this the phenomenon of generic or underqualified managers rearing its head?

Fu says that medical devices need to stop using insecure, unsupported operating systems. "More hospitals and manufacturers need to speak up about the importance of medical-device security," he said after the meeting. "Executives at a few leading manufacturers are beginning to commit engineering resources to get security right, but there are thousands of software-based medical devices out there."

One can only wonder if others have done a Ford Pinto cost-benefit analysis and decided the costs of settlement from injured and dead patients is less than the cost of remediation.

-- SS

10:15 AM

Realizing EHR potential, or avoiding patient endangerment?

I noted an interesting comment posted in the comment thread of Bob Wachter's post "Putting the “A” Back in SOAP Notes: Time to Tackle An Epic Problem."

The comment by Dr. Christine Sinsky reads (there seems to be no way to link directly to it):

Great post Bob.  Ambulatory records are equally in need of brevity and clarity. These notes are often 6 pages of mostly nonsensical boiler plate, formatted on a billing template, leaving the reader asking your question: “but what is going on with the patient?”

After 10 years with our clinic’s EHR (McKesson HAC) and 9 years with our hospital EHR (Cerner), the most important issues I’ve encountered have been

• The time costs of data acquisition: Remember the graphic on a clipboard at the foot of the bed? It was a concise and convenient source of information that has not been reproduced in our EHR. It is now a laborious process to unearth this same information. I/Os and daily weights have become lost data points.

• The time costs of data input: One night on call I did a time trial on six of my admissions: it took an average of 73 seconds to record the admitting orders on paper vs 17 minutes to enter the same orders electronically. And in the electronic world I find myself at higher risk of forgetting the orders I meant to write, as the rigid sequence mandated by the EHR is not always the logical clinical sequence in my mind, and it requires parking orders in my mind until I finish marching through laborious tick boxes.

• Diminished situational awareness. Nurses, doctors and others have a more myopic view of the patient, as it is harder to see trends and to see the big picture. Nurses may only know the meds and the orders that pertain to their shift for example.

• Barriers to synthesis: I find it harder to synthesize the diverse sources of data for a patient when each data bit is tucked away in hard to reach electronic silos, often down long navigational pathways. Sometimes one has to scroll both vertically and horizontally (without freeze frames, so the column and row headings disappear while you scroll) creating a cognitive nightmare.

EHRs will continue to be an important tool going forward; improved usability and a better alignment with clinical workflows are needed if we are to fully realize their potential.

I thought the bullet list not at all surprising, and added the following comment in reply to amplify an implied but unstated point:

Re: “EHRs will continue to be an important tool going forward; improved usability and a better alignment with clinical workflows are needed if we are to fully realize their potential.”

You just described what could indisputably be called serious impediments to care. 73 seconds to 17 minutes? Loss of easily accessed data on I/O and daily weights? Diminished situational awareness?

Perhaps it’s time clinicians stopped sugar coating their statements with PC [politically correct - ed.] niceties such as "... if we are to fully realize their potential”, and were more forceful with a more apt “improved usability and a better alignment with clinical workflows are needed if we are to avoid patient endangerment.”

Disruptive effects like these, in my view, lend more import towards speaking of the latter than of the former.

-- SS

11:37 AM

Contra Costa's $45 million computer health care system endangering lives, nurses say

I am providing a number of editorial comments about this familiar story of health IT difficulties (in red italics), and additionally highlighting familiar themes I have written about at this blog.  This story is rich in those themes:

Contra Costa's $45 million computer health care system endangering lives, nurses say

By Matthias Gafni

Contra Costa Times (CA)mercurynews.com

Posted:   08/14/2012 05:30:07 PM PDT

August 15, 2012 3:55 AM GMTUpdated:   08/14/2012 08:55:52 PM PDT

MARTINEZ -- A new medical computer system used at Contra Costa correctional facilities recommended what could have been a fatal dose of a West County Jail inmate's heart medication last week, an incident that a detention nurse characterized Tuesday as one of many recent close calls with the month-old program.

However, the inmate's nurse was familiar with his medical history, recognized the discrepancy and administered the correct amount of Digoxin.

It's just one of a number of computer errors that medical staffers say have been endangering inmates, medical staff and sheriff's deputies at the county's five jail facilities since Contra Costa switched on July 1 to EPIC, a computer system that links the correctional facilities to the Contra Costa Regional Medical Center and other county health care operations, two nurses and their union representative told the Contra Costa County Board of Supervisors on Tuesday.

"It's dangerous. It's very dangerous," said an emotional Lee Ann Fagan in a phone interview. The registered nurse works at West County Detention Facility in Richmond. "It's hard to work in an environment that's so frustrating.  [Staff frustration increases risk of error and decreases morale, which increases risk of error further - ed.]

"What nurses want is for the EPIC program to go away until it's fixed," she said.

The $45 million EPIC system integrates detention medical records with the other arms of the county health system. The system led to 142 nursing complaints in July, said California Nurses Association labor representative Jerry Fillingim, who told supervisors the system does not mesh well with detention health care.

"I have never in all the time working with the California Nurses Association seen that many (complaints) be filled out," he said. "Each day, these nurses are fearful that they will kill somebody [requiring hypervigilance, which is emotionally and intellectually tiring, increasing risk of error further - ed.] ... I think the county tried to rush it, making it comprehensive for everything."

EPIC has never included corrections in its software and is treating Contra Costa as a "guinea pig," Fillingim said.  [Subjects of this experiment don't get the opportunity for informed consent, I add - ed.]

Guinea pigs to experiments don't give consent

'Just a tool'

The county wanted to create a uniform electronic health record (EHR), and executives said the tool is important, but not the be-all, end-all.

"The EHR is just a tool," said David Runt, chief information officer for the county health services department and who helped phase the system in over 18 months. "It's just one piece of the health care system. The people are the most important part of this process. We can't rely just on a computerized system."  [That's certainly a welcome and much more temperate position than the usual seller and pundit conceit that health IT will "transform" or "revolutionize" medicine.  It is also an especially good observation when the tool is unreliable! - ed.]

... "It's the beginning of a long journey that occurs over time," [i.e., an experiment - ed.] she said. "I think we can do a better job ... at how we communicate everything we're doing to respond to concerns." [The health IT industry has had several decades to "get it right."  When will the experiment end? - ed.]

Management warned

Staff superusers have warned management of EPIC issues, and two training sessions in May and June were inadequate, Fagan said.

"They were next to useless because the program wasn't in place well enough to practice," she said. "Everyone in the classes could see the gross loopholes in information."

Although nurses across the county's health care system have complained [but impediments to diffusion per FDA, IOM etc. prevented the complaints from becoming more widely known - ed.], the problems have been acute in detention, Fagan and Fillingim said.

On Monday, one inmate told a nurse she was supposed to be seen by mental health specialists because she was hearing voices, but the follow-up appointment was not registered in the system. The same patient had a Pap smear scheduled for two weeks ago to test for sexually transmitted diseases, but the appointment disappeared from the system, Fagan said.

Nurses cannot access tuberculosis history for inmates, so when some are transferred to Immigration and Customs Enforcement, staff cannot provide a full medical summary.
"We don't exactly know how that happened; we can't tell," she said.

The kinks will be worked out, and patient safety issues rise to the top of the list, Runt said. ["kinks" is a synonym for that other common, milquetoast euphemism "glitches";  I also ask -  why does the statement that "patient safety issues rise to the top of the list" even have to be made - ever? - ed.]

"When we go live is just a point in time, and now it becomes a period of stabilization and optimization," he said.

I think the line "We don't exactly know how that happened; we can't tell" sums up the dangers of today's "EHR's", in reality enterprise clinical resource management and clinician workflow control systems, very well.

I note that nurses in California may be a bit better prepared to recognize and call out the dangers of ill-designed and ill-implemented health IT than those in other states.  See my post "Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee."

Regulation, anyone, or shall the experiment continue as-is?

Finally, in my career to date, I have both experienced and heard many stories of this type of medical and organizational chaos that endangers patients.  The usual scenario is one of non-medical, domain-novice IT personnel and executives serving as the industry's defense (as in American football), doing their best to tackle anyone who speaks out.  Two such stories arrived in my inbox in just the past few weeks.

The scenarios are also usually accompanied by amoral misdirection from these personnel away from patient risks via hackneyed excuses and euphemisms such as: it's a rare event, it's just a 'glitch', patient safety was not compromised, it's teething problems, it's a learning experience, we have to work the 'kinks' out, it's growing pains, it's the users' fault, etc.   

Herein is the problem:  the attitude that a clinic full of non-consenting patients is an appropriate testbed for alpha and beta clinical software that puts them at risk is medically unethical, based on the guidelines developed from medical abuses of the past.  There is nothing to argue or debate about this.

It is time to consider that some of the ignorant-to-the-point-of-endangerment or corrupt IT and other healthcare executives who do not listen to the concerns of clinicians, or actively block them from being disseminated and acted upon, should be subjected to charges of gross or even criminal negligence when harm occurs.

Gross negligence: carelessness in reckless disregard for the safety or lives of others, which is so great it appears to be a conscious violation of other people's rights to safety.

Criminal negligence:  failure to use reasonable care to avoid consequences that threaten or harm the safety of the public and that are the foreseeable outcome of acting in a particular manner.

Perhaps they'll enjoy experiencing a prison environment with a troublesome EHR firsthand.

-- SS

4:17 AM

Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised

Having been 'Down Under' in Sydney addressing the Health Informatics Society of Australia on the need to slow down their national health IT program - and on the need to think critically about HIT seller public relations exaggerations and hubris - and being very busy, I missed this quite stunning story of a major health IT outage.

Just a typical "glitch":

Some lessons from a major outage
Posted on July 31, 2012
By Tony Collins

Last week Cerner had a major outage across the US. Its international customers might also have been affected.

InformationWeek Healthcare reported that Cerner’s remote hosting service went down for about six hours on Monday, 23 July. It hit “hospital and physician practice clients all over the country”. Information Week said the unusual outage “reportedly took down the vendor’s entire network” and raised “new questions about the reliability of cloud-based hosting services”.

A Cerner spokesperson Kelli Christman told Information Week,

“Cerner’s remote-hosted clients experienced unscheduled downtime this week. Our clients all have downtime procedures in place to ensure patient safety.  [Meaning, for the most part, blank paper - ed.] The issue has been resolved and clients are back up and running. A human error caused the outage.  [I don't think they mean human error as in poor disaster recovery and business continuity engineering - ed.]  As a result, we are reviewing our training protocol and documented work instructions for any improvements that can be made.”

Christman did not respond to a question about how many Cerner clients were affected. HIStalk, a popular health IT blog, reported that hospital staff resorted to paper [if that was true, that paper was OK in an unplanned workflow disruption of major proportions, then why do we need to spend billions on health IT, one might ask? - ed.] but it is unclear whether they would have had access to the most recent information on patients.

One Tweet by @UhVeeNesh said “Thank you Cerner for being down all day. Just how I like to start my week…with the computer system crashing for all of NorCal [Northern California].”

Tony Collins is a commentator for ComputerWorldUK.com.  He's quoted me, as I wrote in my May 2011 post Key lesson from the NPfIT - The Tony Collins Blog.

This incident brings to life longstanding concerns about hospitals outsourcing their crucial functions to IT companies.  

Quite simply, I think it's insane, at least in the foreseeable future, as this example shows.

It also brings to mind the concerns that health IT, as an unregulated technology, causes dangers in hospitals with inadequate internal disaster and business continuity functions aside from fresh sheets of paper.  Such capabilities would likely be mandatory if health IT were meaningfully regulated.

The Joint Commission, for example, likely issued its stamp of approval for the affected hospitals, hospitals who had outsourced their crucial medical records functions to an outside party that sometimes went mute.  If someone was injured or died due to this outage, they would not care very much about the supposed advantages.

There's this in the article:

... “Issue appears to have something to do with DNS entries being deleted across RHO network and possible Active Directory corruption. Outage was across all North America clients as well as some international clients.”

Of course, patient safety was not compromised.

Finally:

Imagine being a patient, perhaps with a complex history, in extremis at the time of this outage.  

I, for one, do not want my own medical care nor that of my relatives and friends subject to cybernetic recordkeeping unreliability and incompetence like this, and the risk it creates.

-- SS

Aug. 8, 2012 addendum:

The Los Angeles Times covered this outage in a story aptly entitled "Patient data outage exposes risks of electronic medical records."

They write:

Dozens of hospitals across the country lost access to crucial electronic medical records for about five hours during a major computer outage last week, raising fresh concerns about whether poorly designed technology can compromise patient care.

My only comment is that the answer to this question is rather axiomatic.

They also quote Jacob Reider, acting chief medical officer at the federal Office of the National Coordinator for Health Information Technology, who said:

"These types of outages are quite rare and there's no way to completely eliminate human error"

This is precisely the type of political spin and misdirection I cautioned the Australian health authorities to evaluate critically.

Paper, unless there is a mass outbreak of use of disappearing ink, or locally hosted clinical IT, do not go blank en masse across multiple states and countries for any length of time, raising risk across multiple hospitals greatly, acutely and simultaneously.  (Locally hosted IT outages only cause "local" mayhem; see my further thoughts on this issue here).

-- SS

11:08 PM