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

EHRs and Ebola in the Texas Health Presbyterian Hospital ED: the ED physician finally speaks out

At my Oct. 2, 2014 post "Did Electronic Medical Record-mediated problems contribute to or cause the current Dallas Ebola scare?" (http://hcrenewal.blogspot.com/2014/10/did-electronic-medical-record-mediated.html) I had written:

While I have no evidence as to any role of EHRs in this seemingly strange, cavalier and incomprehensible medical decision to send this man home, resulting in potential exposure of numerous other individuals to Ebola (and I am certainly not in a position to have such evidence), I believe this possibility [that is, an EHR-related information snafu - ed.] needs to be investigated fully.

 
I then did an update:

10/3/2014 Update:

My suspicions were apparently correct.  [The hospital admitted an EHR role - ed.]

Then, the hospital retracted its admission, blur and obfuscation broke loose in the press, and the situation became foggy.  See posts by Roy Poses and myself at query link http://hcrenewal.blogspot.com/search/label/Ebola%20virus, including Dr. Poses' Nov. 24, 2014 post "Public Relations and the Obfuscation of Management Errors - Texas Health Resources Dodges its Ebola Questions" at http://hcrenewal.blogspot.com/2014/11/public-relations-and-obfuscation-of.html.

Finally, the primary clinician involved speaks.  Do read the whole article, as it delves into behind-the-scenes issues:

ER doctor discusses role in Ebola patient’s initial misdiagnosis
By REESE DUNKLIN and STEVE THOMPSON
Dallas Morning News
Dec. 6, 2014
http://www.dallasnews.com/ebola/headlines/20141206-er-doctor-discusses-role-in-ebola-patients-initial-misdiagnosis.ece

... "[ED physician Joseph Howard Meier's] notes in the medical records say he had reviewed the nursing notes. Hospital officials told Congress that the ER physician several times accessed portions of the electronic records where the nurse had recorded Duncan’s arrival from Africa. It wasn’t clear, though, “which information the physician read,” hospital officials told Congress. 

Meier told The News he hadn’t seen the Africa notation in Duncan’s records. The physician said the hospital’s electronic medical records system contained a lot of information, which, like patients, “must also be triaged.” 

Clinicians in an ED have to "triage" information from their records systems, just like patients need to be triaged?  That is a candid and astonishing (to anyone with common sense) admission.

Paper charts never had those problems in my own time working in the ED.

Further, ED charts used to be relatively brief, which is why as a Chief Medical Informatics Officer I recommended document imaging systems only in ED's, to make charts available 24/7/anywhere, and data transcriptionists to capture important data into computers later, not full EHR systems where clinicians enter data which I felt (and still feel) are inappropriate in faced-paced, high-risk settings.

(Put another way, the experiments of direct data entry by busy clinicians, and clinicians attempting to drink information from a tangled cybernetic EHR firehose, are proving a failure.)

... The “travel information was not easily visible in my standard workflow,” he said. “This has now been modified very effectively.”

Modified only after near-catastrophe.  How many other "modifications" (i.e., experimental software changes) will be needed over time in this and other EHRs, I ask?  (Perhaps 10,000 such as here: http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html?)

... The News asked Meier whether knowing Duncan’s travel history would have changed his evaluation. 

“If he told me he came from Liberia, this would have prompted me to contact the CDC and begin an evaluation for Ebola,” Meier said, “but the likelihood would have still been low since Mr. Duncan denied any sick contacts.”

Over the next few hours, Meier ordered tests, along with an IV for saline. He prescribed extra-strength Tylenol, which the nurse gave Duncan at 1:24 a.m. Meier reviewed Duncan’s vital signs. CT scans of Duncan’s head were “unremarkable,” the medical records say, showing no sign of sinusitis.

Doctors typically order CT scans to rule out more serious possibilities, such as a hemorrhage or meningitis. In his responses to The News, Meier said he ordered the CT scan because of Duncan’s headache.

Meier did not say whether the CT scan’s lack of an indication of sinusitis factored into his diagnosis. “Sinusitis is mostly a clinical diagnosis,” he said.

At 3:02 a.m., Duncan’s temperature was 103 degrees, his medical records say. Sixteen minutes later, however, Meier entered a note saying: “Patient is feeling better and comfortable with going home.” Meier told The News he hadn’t seen the higher temperature in Duncan’s chart.

Duncan was discharged at 3:37 a.m. with the diagnosis of sinusitis. His last recorded fever, at 3:32 a.m., was 101.2 degrees. Meier prescribed Duncan the antibiotic Zithromax, 250-milligram tablets, to be taken twice the first day and once daily for four more days.

I note two things:

1.  If an EHR company has hiring practices allegedly such as described via Histalk blog at my Aug. 15, 2010 post "EPIC's outrageous recommendations on healthcare IT project staffing" (http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html), where rank-novice recent college graduates suddenly become EHR experts afters some transfusion of wisdom at corporate HQ (perhaps via this alien neural interface device that imparts the Knowledge of the Ancients: http://stargate.wikia.com/wiki/Repository_of_knowledge?), then what can one expect?

The Stargate neural interface device that imparts the Knowledge of the Ancients via direct brain download.  Presto - instant EHR expert!

and

2.   I note what I am going to somewhat satirically going to call the "Silverstein EHR principle", that states:

• When bizarre and otherwise inexplicable information-related snafus occur in hospitals, especially in fast-paced, high-risk areas, suspect bad health IT as causative or contributory as #1 in your differential diagnosis (or post-mortem, as the case may be).

-- SS

1:16 AM

Judy Faulkner and EPIC, Show us your EHR screens

At "Congressional committee releases timeline detailing how Presbyterian treated Ebola patient Thomas Eric Duncan", Dallas News, Oct. 17, 2014 there is a link that provides acccess to documents released by the U.S. House of Representatives' Energy and Commerce Committee.

These documents address the EHR issues in the care of Ebola patient Thomas Duncan I wrote of at my Oct. 2, 2014 post "Did Electronic Medical Record-mediated problems contribute to or cause the current Dallas Ebola scare?" (http://hcrenewal.blogspot.com/2014/10/did-electronic-medical-record-mediated.html) and others:

Congressional committee releases timeline detailing how Presbyterian treated Ebola patient Thomas Eric Duncan

By Robert Wilonsky
Dallas News
Oct. 17, 2014 

http://thescoopblog.dallasnews.com/2014/10/congressional-committee-releases-timeline-detailing-how-presbyterian-treated-ebola-patient-thomas-eric-duncan.html/

According to a timeline released moments ago by the U.S. House Energy and Commerce Committee, Texas Health Resources Presbyterian Hospital Dallas released Thomas Eric Duncan at 3:37 a.m. on Sept. 26 — just 35 minutes after his temperate jumped to 103 degrees.

The timeline, provided by Presbyterian officials, also shows that “obtaining the patient’s travel history was not part of the triage nurses’ process on September 25, 2014,” when Duncan initially went to the hospital. He arrived in Dallas from Liberia five days earlier. A nurse noted that he’d just come from Africa but “attached no further significance to this travel history,” according to the timeline.

Another document shows how Presbyterian prepared to deal with Ebola dating back to Aug. 1 when officials were told that all Emergency Health Records should include a travel history for every patient. In Duncan’s case, it’s not clear whether a doctor read his emergency health records.

“The record does not show which information the physician read, only which information was available,” according to the timeline.

The documents are available at https://www.scribd.com/doc/243373964/Thomas-Duncan-Presbyterian-Treatment-Time-Line

The key phrase to parse is the one also quoted in the newspaper article above:  “The record does not show which information the physician read, only which information was available.”

From the timeline itself, in pertinent part:

12:33 – 12:44 a.m. RN assessment
- The primary ED nurse continues the assessment.
- She identifies his complaints as “sharp, intermittent epigastric/upper abdominal pain;
sharp, frontal headache; dizziness; lack of appetite”
- She asks about Mr. Duncan’s travel history.
- The nurse documents that Mr. Duncan “came from Africa 9/20/14"
- RN states she recalls the discussion because of how long the plane flight was. (She had personal experience with very long plane fights). Attached no further significance to this travel history.
- This information was not verbally communicated to the physician, as prompted by the EHR.

12:52 – 1:10 a.m. ED physician begins evaluation of Mr. Duncan
The ED physician accesses the EHR again. A review of the EHR shows that the physician, on several occasions, accessed portions of the EHR where the travel history was now available including:
ED Lab Results Screen
ED Triage [twice]
ED Rad Results

The record does not show which information the physician read, only which information was available.

Again, the statements that the physicians "accessed portions of the EHR where the travel history was now available" after the RN recorded it, and that "the record does not show which information the physician read, only which information was available" sound like lawyers writing to obfuscate EHR realities from our Congresspeople.

Let's examine these statements:

• ED physicians "accessed portions of the EHR where the travel history was now available" after the RN recorded it, and

• The record does not show which information the physician read, only which information was available

These is a fundamental semantic problem here with the word "available."  In an EHR, "available" has a far different meaning than in a paper record.

The question is:

What is the precise meaning of the word "available" as stated here?

• (1)  Does "available" mean "present on the actual screen(s) the physicians had up at one time or another on the monitor, that made up the "portions" of the EHR they "accessed"?"  

• In other words, was the positive travel history from Africa "illuminating the phosphor", or illuminating the LED arrays for a modern computer monitor, of an actual screen in actual eyesight of the physicians that was a subset of the "portions of the EHR" they accessed?

 Or (and I believe this quite possible):

• (2)  Does "available" mean that the travel history was available as data on disk or on RAM, and thus potentially on a screen for a physician to see, but that the specific screen never actually illuminated the LED arrays on the physicians' monitors? (E.g., such screen(s) were a component or subcomponent of the EHR "portions" they accessed, but the specific screen(s) in those "portions" had to be navigated to in order to see the travel data.)

• In other words, was the case that the travel information taken by the nurse never appeared visually to the physicians, but only resided in the computer as data where it was invisible as intangible bytes on a disk or in RAM?  (This does not happen with a paper chart - the paper is tangible.)

• Further, was there a meaningful alert drawing the physician to a screen that did then present the travel data to them?

There is no way to know by parsing the words, but based on their semantic blur I suspect the second scenario.

Unfortunately, what  really is essential to understand the EHR interaction are screenshots of precisely the screens viewed by the physicians, not "available" to the physicians.

Note that, for example, my Windows System Event log is "available" to me at all times in "portions" of Windows I may look at - by right-clicking "My Computer" and clicking the "manage" menu item that appears -  and only then if I actually then navigate to find it.  

Of course, EPIC and the other EHR sellers do not make the actual EHR screens available to the public - they are considered "protected IP."

Perhaps it's time for EPIC and the Texas Health Presbyterian Hospital to show Congress their screens.

Assuming they even know what screens to show.  EHR audit trails of user activity are notoriously imprecise. 

-- SS

10/21/14 Addendum:

At Health Data Management (http://www.healthdatamanagement.com/news/Epic-Stands-By-Integrity-of-EHR-System-at-Dallas-Hospital-49039-1.html),  Carl Dvorak, president of Epic Systems Corporation, is quoted as saying "... obviously it [the travel history - ed.] was on the opening screen of the physician’s workflow.”

I say:  prove it.  And as above, prove the doctors actually "put the data up into the screen LEDs."

Show the screens (before the hospital changed them, I add).

Show the audit trail.

This EPIC statement makes no sense, considering the hospital's initial claims as I wrote about earlier:

http://www.wptz.com/health/urgent-ebola-texas-hospital-flaw/28381038

(CNN) -- The Texas hospital treating the first person diagnosed with Ebola on American soil says a "flaw" in its electronic health records prevented doctors from seeing the patient's travel history. Patient Thomas Eric Duncan told the nurse he'd been in Africa, but that information was entered into a document that isn't automatically visible to physicians, Texas Health Presbyterian Hospital Dallas said in a statement Thursday.

However, the screens and the audit trail are the only way to authenticate the EPIC claims.

-- SS

9:44 AM

In addition to nurses, doctors now air their alarm: Contra Costa County health doctors air complaints about county's new $45 million computer system

At my Aug. 2012 post "Contra Costa's $45 million computer health care system endangering lives, nurses say", I described how an experimental EHR being forced on clinicians in Contra Costa county, California, was endangering patients who had not consented to its use, and how nurses were reported to be raising hell about it.  I also noted:

... The[se] scenarios [of EHR-created mayhem] are also usually accompanied by amoral misdirection from these personnel away from patient risks...

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. 

Now the affected physicians have their say.

These physicians are apparently represented by a union; therefore they likely fear retaliation less than non-union physicians, and thus can be candid:

Contra Costa County health doctors air complaints about county's new $45 million computer system
By Matthias Gafni
Contra Costa Times
Posted:   09/18/2012, Updated:  09/19/2012

MARTINEZ -- One of every 10 emergency room patients at the county's public hospitals in September left without ever being seen by a doctor or nurse because of long waits -- a number rising since implementation of Contra Costa's $45 million computer system July 1.

One patient waited 40 hours to get a bed.

Dr. Brenda Reilly delivered the troubling news Tuesday afternoon to county supervisors. She was one of three dozen doctors in the supervisors' chamber complaining about EPIC, new computer software aimed at integrating all of the county's health departments to create a federally mandated electronic medical record for patients.

The response, as seen later, were characterized by the typical amoral excuses, mistaken beliefs in technological determinism, (a/k/a quasi-religious computer fanaticism) and misdirection I described above.

To allow for the major computer program installation and conversion, administrators cut doctors' patient loads in half, in turn cutting the number of available appointments in half.

In a letter to the supervisors, Dr. Ori Tzvieli -- medical staff president whose union has been negotiating a new contract with the county -- along with 14 doctor co-signers pleaded for administrators to continue scaling back physician workloads because doctors are over-stressed. Six doctors have left this year, said Dr. Keith White, a 22-year pediatrician.

I point out that such stress from interacting woth a mission hostile EHR (really, a clinician workflow-control system), and the needed state of hypervigilance to avoid IT-related mistakes that harm patients, lead to burnout and ultimately, a lower quality of patient care. 

Patient workloads were reduced by 50%, which is bad enough (and indicative of gross project mismanagement, as I wrote about in another example in my Sept. 2012 post "Lake County (IL) Health Department: The extremes to which faith-based informatics beliefs can drive healthcare facilities - Depression era soup lines at the clinic?").

Yet the 50% reduction, according to the principal end users, was still not enough.  Usability and fitness of the software is surely in question.

"We were not ready for EPIC and EPIC was not ready for us," White told supervisors. "As a result, the providers are struggling to provide safe and effective care for 100,000 citizens of the county, many of whom are very ill. We often feel that we are failing. We are very tired ... many doctors have left and all are considering leaving."

It is impossible for people, especially medical professionals, to be "ready" for a system that "is not ready for them", i.e., "bad IT" as defined at my teaching site intro at this link:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.
   
Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

The two phrases "We were not ready for EPIC" and "EPIC was not ready for us" do not belong together in the same sentence.

A claim that physicians (and nurses) are "struggling" to provide safe let alone effective care for 100,000 should RAISE ALARM BELLS, not produce a paternalistic, patronizing response from medical and governmental officials as it did, seen below.

Both doctors and administrators agreed Tuesday that creating an integrated electronic health record is important, but a series of white coats stepped to the podium in what they jokingly termed "Doccupy" to share their nightmarish last few months.

I disagree with the assessment that "creating an integrated electronic health record is important", in that the technology and know-how to do so without endangering the very patients the technology is supposed to protect does not yet seem to exist in the commercial sector.

In that sense, regulating EHR technology and subjecting it to controlled clinical trials and refinement (as with any other medical device or drug, and many other types of healthcare-related IT such as MDDS - medical device data systems) with consenting subjects is what's important.

On MDDS, from the FDA link above:

Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS are not intended to be used for active patient monitoring. Examples of MDDS include:

• software that stores patient data such as blood pressure readings for review at a later time;
• software that converts digital data generated by a pulse oximeter into a format that can be printed; and
• software that displays a previously stored electrocardiogram for a particular patient.

The quality and continued reliable performance of MDDS are essential for the safety and effectiveness of health care delivery. Inadequate quality and design, unreliable performance, or incorrect functioning of MDDS can have a critical impact on public health.

That health IT used on live patients receives special regulatory accommodation in the form of non-regulation, when clearly the quality and continued reliable performance of EHR systems are essential for the safety and effectiveness of health care delivery, is inexcusable in 2012.  

(Of course, stunningly, FDA won't touch the latter, although admitting they are medical devices that should fall under the FD&C Act, because EHRs are a "political hot potato."  See this post for the relevant citations.)

... "This has been excruciatingly painful to do what is needed for those people who need it most," said Dr. Rachel Steinhart, an emergency room doctor who worked a graveyard shift ending Tuesday morning, hours before the board meeting. She said she still had to document paperwork for 16 of her patients. "It's going to implode. It can't go on like this."

Patients are surely going to be injured or killed in this setting.  There is likely a "hold harmless" clause with the vendor, so, doctors, I'm sorry to say, despite your complaints, you will very likely be held legally liable.

The head of the county's health care system sympathizes, and hopes to work with medical staff to ease the transition for what is a monumental moment in medical history.

"We're in an era of massive change right now, not only in our system, but in the system nationwide," said Dr. William Walker, Contra Costa's health services director. "Coming with the rapidity is its throwing people off balance."

Dr. Walker has just painted a big red "name me as a defendant for gross negligence and breach of fiduciary responsibilities to patients and clinicians" target on his back for glossing over known health IT risks and what appear to be rather profound complaints coming from his constituents.  Instead, he supplies platitudes, not action to remediate or withdraw the bad IT.

Name me as a defendant for gross negligence and breach of fiduciary responsibilities to patients and clinicians

The response is stunning:

To ease the burden, Walker hopes to have teams of medical care providers formed to ease the doctors' paperwork burden, enabling them to return to treating patients.

It takes teams of physicians to properly see a patient due to the interference of EHRs?  That is remarkable.

The ccLink program has its benefits, some doctors said. Dr. Chris Farnitano, an ambulatory care medical director, described how he retrieved a patient's biopsy results from a different hospital on the spot, whereas in the past it would have taken weeks.

However, other doctors called ccLink clunky and time-consuming, designed more for bureaucrats than physicians. Even with doctors cutting their patient load in half -- meaning half as many appointments are available for patients -- doctors complained that they spend more time on their computers than treating patients.

This is misdirection by the Medical Director.  It's unarguable that the risks far outweigh the benefits.  Further, retrieving a biopsy or other result result instantaneously could easily be done from an innocuous, non-disruptive document imaging system (e.g., Documentum).  The latter would also be many millions of dollars less expensive than an EHR.

"It's a truncation of patient care. The individual patient doesn't get the care they used to get," said David MacDonald, a 22-year family medicine doctor.

Again, Dr. MacDonald, the liability for adverse outcomes is on you.

You are now, in effectm an indentured servant of an IT company, providing free alpha and beta testing at your expense and peril, using the patients as an even lower level of indentured servant/guinea pig.

There's also significant patient-endangering collateral damage from this mayhem:

The lack of appointments has overburdened emergency rooms, which already exceeded emergency room wait benchmarks in a facility built to see 80 patients a day, but often sees more than 200 patients a day. Since ccLink started, the average patient spends four hours in the ER, up an hour from before the computer system transition, which was already over national benchmarks, said Reilly.

The scenario could not be worse.  The ED's are themselves burdened by EHR's.

The supervisors asked for continued updates, and for patience.

"Continuous improvement means you need continuous change," said supervisor Federal Glover. "Eventually, it's going to become second nature as it was with cell phones. We'll wonder how we ever did without it."

Supervisor Glover has also painted a "defendant" target on his back.  This is the misdirection I was speaking of earlier, consisting of platitudes, logical fallacy and falsehoods:

• "Continuous improvement" is not what's going on here; 
• Such improvement does not mean creating chaos as a precondition; 
• Whether this software will become "second nature" is anyone's guess.  That is a hysterical and logically fallacious statement (e.g., an appeal to belief) of an almost quasi-religious fanaticism regarding computing.  This technology could ultimately be scrapped in favor of, say, simpler document imaging systems due to increasing clinician complaints, inherent usability issues in fast-paced medical settings, litigation, costs, harms etc.;
• What of the patients placed at risk, and/or injured/killed as a result of this experimentation?  What of them, and their medical and human rights?

In effect, a response like this is medically unethical.  The correct response would be a halt in the rollout until problems are substantially remediated in a controlled, risk free setting - not the clinic.

If that is not possible, the system needs to indeed be scrapped or replaced.

Continuation of patient endangerment is inexcusable medically, ethically and legally.

-- SS

7:49 AM

Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?

At my Aug. 31, 2012 post "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" I wrote that healthcare IT vendor EPIC was advising customers in what to write in their "Public comments" regarding the proposed Meaningful Use Stage 2 Final Rule, the requirements of which permit financial incentives to be received by a user if met by an EHR.

It appears they may have been successful.

Note their apparent boilerplate "recommendations" regarding § 170.314(a)(9) - Electronic notes.  This comes from the numerous filings with the accidentally unredacted "Informational Comments for Organizations Using Epic (remove before submitting to ONC)" note, and others without.   Pay specific attention to the "Tertiary Recommendation":

Major Concern

As detailed in our introduction, we are significantly concerned that the scope of the certification program is endangering some of the goals of Meaningful Use by introducing unnecessary overhead and burden.

As electronic notes are not proposed as a Meaningful Use objective with the rationale that electronic notes are already in common use, we do not think certification on this criterion is necessary, and suggest removal. Introducing unnecessary certification criteria creates expense for ONC, certifying bodies, and EHR developers, and does not provide significant value to the marketplace.

Recommendation
Keep consistent with CMS and remove this criterion from the Final Rule.

Secondary Recommendation
If this criterion is retained in the Final Rule, we suggest that the criterion should be an optional certification for the same reasons, and we make the following suggestions:

We agree with your assessment that having notes be searchable provides increased value over notes that are part of a scan or other formats that are not able to be searched. Our experience shows that note search capabilities is complex with potential for innovation in how information is found and displayed. Prioritization of such capabilities is best left to the marketplace. Search is not essential to meet the not-proposed objective drafted by CMS. Focus certification on the minimum floor set of capabilities required to complete meaningful use objectives. Therefore, we suggest that search capabilities be excluded from certification.

Tertiary Recommendation
If this criterion is retained in the Final Rule and is not made optional, a reasonable requirement for certification would be the ability to search for a free-text string within a particular open note. Other search capabilities should be left as competitive differentiators within the marketplace. Specific certification requirements could interrupt innovative ways to do effective chart search and information display.

Informational Comments for Organizations Using Epic (remove before submitting to ONC)

We’ve heard your requests for a chart search feature, and our desire to see this certification criterion removed does not mean we don’t want to develop such a feature. In a future version of Epic, we want to develop the best possible chart search feature based on your input. However, if this criterion stays in the Final Rule, we worry we’ll have to divert attention from future chart search features you’ve requested to focus on a simplified, less valuable version of the feature to meet certification.

Our comments [presumably, those above - ed.] stem from the fact that we believe that you prefer we focus our attention on the more sophisticated chart search feature you have requested in a future version.

The ability to search for a free-text string within an already open [on-screen] note is not of very much value (near useless perhaps?) compared to the ability to search an open patient's record for all notes that contain a string, or across a set of many records, for free-text strings or other values. Think Windows 7 "Search programs and files" at the Start menu, the MS Win XP add-on Windows Search 4.0 for Windows XP, or MacOS's Spotlight.

(Is there, I ask, a commercial EHR that cannot search for a free-text string within a "particular open note"?  Further, any web browser can search screen contents for text strings, I add, so if the EHR is using a browser, that feature comes as a freebie.)

Now note from the MU Stage 2 NPRM (Proposed Rule as in the Notice of Proposed Rulemaking) that appeared in the Federal Register on Mar. 7, 2012.  The relevant passage about note searching is highlighted in green:

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 170
RIN 0991-AB82
Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology
AGENCY: Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services.
ACTION: Proposed rule.

§ 170.314(a)(9) - Electronic notes

• Electronic notes

MU Objective Record electronic notes in patient records.

2014 Edition EHR Certification Criterion § 170.314(a)(9) (Electronic notes)

The HITSC recommended a certification criterion similar to the 2014 Edition EHR certification criterion we propose at § 170.314(a)(9) (with specific reference to "physician, physician assistant, or nurse practitioner" electronic notes) to support the MU objective and measure recommended by the HITPC. CMS has not proposed the MU objective and measure for Stage 2, but has requested public comment on whether the objective and measure should be incorporated into Stage 2.

Consistent with our discussion in the preamble section titled "Explanation and Revision of Terms Used in Certification Criteria," we have replaced the terms "modify" and "retrieve" in the recommended criterion with "change" and "access," respectively. Additionally, we are providing the following clarifications for the electronic "search" capability. "Search" means the ability to search free text and data fields of electronic notes. It also means the ability to search the notes that any licensed health care professional has included within the EHR technology, including the ability to search for information across separate notes rather than just within notes. We believe that this certification criterion would encompass the necessary capabilities to support the performance of the MU objective and measure as discussed in the MU Stage 2 proposed rule.

Note the robust "search" capability proposed - the ability to search the notes that any licensed health care professional has included within the EHR technology, including the ability to search for information across separate notes rather than just within notes.

Now, finally, note the Final Rule:

On pg. 300 of final rule at http://www.ofr.gov/OFRUpload/OFRData/2012-21050_PI.pdf it says:
 

Stage 2 Measures:

Enter at least one electronic progress note created, edited and signed by an eligible professional for more than 30 percent of unique patients with at least one office visit during the EHR reporting period.

Enter at least one electronic progress note created, edited and signed by an authorized provider of the eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) for more than 30 percent of unique patients admitted to the eligible hospital or CAH's inpatient or emergency department during the EHR reporting period.

Electronic progress notes must be text-searchable. Nonsearchable notes do not qualify, but this does not mean that all of the content has to be character text. Drawings and other content can be included with searchable text notes under this measure.

pg. 553:

Enter at least one electronic progress note created, edited, and signed by an eligible professional for more than 30 percent of unique patients with at least one office visit during the EHR reporting period.

Enter at least one electronic progress note created, edited and signed by an authorized provider of the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) for more than 30 percent of unique patients admitted to the eligible hospital or CAH’s inpatient or emergency department during the EHR reporting period.

Electronic progress notes must be text-searchable. Nonsearchable notes do not qualify, but this does not mean that all of the content has to be character text. Drawings and other content can be included with searchable notes under this measure.

It would appear, and readers, please correct me if I am mistaken, that the very short criteria specified here - "Electronic progress notes must be text-searchable" - would be satisfied by "the ability to search for a free-text string within a particular open note" per the vendor-authored Tertiary Recommendation, shown supra.

I've searched the MU Stage 2 Final Rule (Adobe Acrobat can do that, but I probably could have used Windows search itself depending on document length) seeking terms from the NPRM such as "search", "information across", "notes", "free-text" etc.  However, I cannot find anything approaching the NPRM § 170.314(a)(9) clarification regarding the meaning of "electronic search capability."

I ask:  what was the role of the Tertiary Recommendation received by ONC from multiple EPIC user organizations?

-- SS

3:38 PM

Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?

Note: Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html.

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

From the Histalk blog in the 8/31/12 news at this link:

Epic not only submitted MU Stage 2 comments to ONC, it even helpfully distributed them to their customers so they could submit the same comments under their own names. David Clunie noticed this and lists the hospitals who sent in the boilerplate, including University of Miami, which submitted the same comments five times without noticing the “Remove Before Submitting” headline that prefaced Epic’s explanation of why its customers should share its opinions with Uncle Sam.

From the primary source linked in the Histalk note:

Epic via University of Michigan Health System Meaningful Use Workgroup also the same Epic comments from University of Miami (who liked them so much they submitted it twice and then a third time and then a fourth and fifth time) and again from the Martin Health System and Metro Health Hospital and The Methodist Hospitals and Fairview Health Services and Sutter Health and Parkview Health System and the Everett Clinic and Dayton Childrens' and UMDNJ and NYU Langone Medical Center and Hawaii Pacific Health and finally as submitted by Epic themselves - others like the Community Health Network just stated they had read and agreed with Epic's comments - Imaging - concur that DICOM is not needed for that objective and PACS images do not need to be duplicated - concerned about single sign on if two systems - View, Download and Transmit to 3rd Party - images are not in the EHR but the PACS - patients would need DICOM viewers - size of the images is a problem - disks are better (also if you look at some copies of this, there are some pretty funny "remove before submitting to ONC" notes that say things like which versions support what and how much it would cost to retrofit, etc.; how embarrassing, both for Epic and their lackeys at these institutions)

I certainly admire David Clunie's endurance at being able to slog through all of that and appreciate his shedding some sunlight on the "remove before submitting" notes, but - I don't think it's funny at all.

Among other things, it represents taint of the submissions via ghostwriters (unattributed authors) with obvious conflicts of interests, topics often addressed at HC Renewal.

Here's an example I verified, the submission to the government from Dayton Children's Hospital:

"Informational Comments for Organizations Using EPIC (remove before submitting to ONC)" - click to enlarge.  At least here they say they are "in total agreement" with EPIC's concerns and recommendations. 

Another example - University of Miami:

A danger of dealing with incompetents:  they neglect to tidy up for you - click to enlarge.  (Corollary question: note the line "Our [Epic's - ed.] comments stem from the fact the we believe ..."  So - what opinions belong to the 'public commenting organization', and which to the company?  Likely the whole thing belongs to the latter's ghostwriters, but can anyone really tell?  That's the problem with tainted submissions.)

Others is the links above I checked such as Martin and Methodist have the same boilerplate about the "chart search feature."  Some retain the "reminder" to remove; in others it has been erased.  However, the boilerplate remains.

I actually find the "advice" from EPIC in the latter document stunning regarding a "chart search feature" (e.g., search note text, and probably also ad hoc clinical searches such as 'find my patients whose blood sugars have been > 100 in the past month').  These are "features" critical to quality care that should have been present decades ago ** [see note below].  Emphasis mine:

... Focus certification on the minimum floor set of capabilities required to complete meaningful use objectives.

Is this a tacit admission "certification" is a sham?  Is this in patients' best interests?

and

Informational Comments for Organizations Using Epic (remove before submitting to ONC)
We’ve heard your requests for a chart search feature, and our desire to see this certification criterion removed does not mean we don’t want to develop such a feature. In a future version of Epic, we want to develop the best possible chart search feature based on your input. However, if this criterion stays in the Final Rule, we worry we’ll have to divert attention from future chart search features you’ve requested to focus on a simplified, less valuable version of the feature to meet certification.

In my opinion, this translates to: "we are already overextended, so help us stymie the experts' and government's efforts to make it a criteria for certification, and to hell with your doctors and nurses who need a search feature right now."

Can you imagine in 2012 a word processor, database or operating system without a search feature?  That's the kind of antediluvian IT the clinicians have to put up with.  And this industry speaks of "innovation?"

It would come as no surprise - to me, at least - if other health IT sellers were engaged in similar activities.

I am unable to judge whether stealth lobbying by sellers using their clients, which enables the sellers to then line their pockets through favorable government legislation based on echoed comments of clients, is legal or ethical.  My belief, however,  is that it is at best a questionable practice.  It is certainly inherently unfair e.g., anti-competitive in regard to smaller health IT companies who might be able to meet more stringent MU2 certification criteria, and unfair to private citizens who have no such captive mouthpieces at their beck and call. 

While perhaps not as bad as possible 'Combination in Restraint of Trade' as in my April 2010 post "Healthcare IT Corporate Ethics 101" (link), this situation should probably be brought to the attention of health IT watchdogs such as Sen. Grassley.

This May 2012 post might also be of interest:  Did EPIC CEO Judy Faulkner of Epic declare that 'healthcare IT usability would be part of certification over her dead body'?  ONC never responded to the questions I raised in the post.

Another question:  why did ONC apparently turn a blind eye towards these "accidental inclusions"? 

Yet another question:  is the MU2 Final Rule invalid due to the influence the industry clearly had on the submitted "public" comments, which can now reasonably be viewed as tainted?

-- SS

Addendum:

I've informed the Senator via his email and staff voicemail lines.  I've also created a short URL to more conveniently access this post:  http://www.tinyurl.com/epic-stealth

Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html.

-- SS

Note:

** For instance, I had  implemented a robust search feature of clinical notes, all comment fields and the comprehensive clinical, genetic and genealogical dataset in the Yale-Saudi Clinical Genetics EHR - in 1995.

6:22 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

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

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

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

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

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

FierceEMR.com
July 13, 2012

By Dan Bowman

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

5:55 AM