My mother passed away

My mother, affected catastrophically by an EHR error last year and the topic of numerous posts here (such as this), passed away yesterday evening.

In her memory, a photo of her and me from 1957 I found in her possessions.

Betty Silverstein, 1925-2011

Her children were always Number One.

May she rest in peace, and may my efforts result in others not having to suffer similar mistakes at the hands of IT.

-- SS

Healthcare Renewal Cited in Pittsburgh Post Gazette on Health IT Issues

Healthcare Renewal was cited in the Pittsburgh Post Gazette today on health IT issues.

Specifically, regarding issues I raised at my May 25, 2011 post "Transplant Team at UPMC Missed Hepatitis Result - Suspicious for Health IT Failure?"

I have several additional amplifying comments.

Doctor, nurse disciplined by UPMC
Failed to detect hepatitis C in kidney donated for transplant
Friday, May 27, 2011
By Jonathan D. Silver and Sean D. Hamill, Pittsburgh Post-Gazette

A surgeon and a nurse were disciplined by UPMC for their roles in missing a positive hepatitis C test result in a kidney donor earlier this month that might have stopped the transplant, the hospital system said Thursday.

The surgeon was demoted and the nurse suspended, though neither has been identified.

In addition, after a discussion with federal officials, the hospital system voluntarily suspended its live-donor liver program as a precaution, three days after shutting down its live-donor kidney program on May 6, following the transplant error. Both programs remain closed.

But while UPMC has taken action against the two staff members, health care technology experts say UPMC's information technology might have played a role in the incident.

"Checking for all types of hepatitis is so ingrained in the culture of doctors," said Scot Silverstein, a medical informatics expert and adjunct professor at Drexel University in Philadelphia. "If they didn't check for hepatitis C, that means they didn't check for hepatitis A or B either, and that means they didn't check for anything."

"That just isn't credible," said Dr. Silverstein, who explored the possible ways the technology played a role in the kidney transplant error in the blog Health Care Renewal.

"There are two possibilities," he said. "Either you have a dozen or more people on that transplant team who are just stupid, or, more plausibly, when they looked at the record the hepatitis C record was just not there or it was incorrect when they saw it."

The incident first came to light May 6, when UPMC notified the Centers for Medicare and Medicaid (CMS) as well as the United Network for Organ Sharing, that it had detected an error in a recent kidney transplant.

It was a living kidney transplant between a woman and a man who are a couple, sources have told the Post-Gazette. The woman did not know she was hepatitis C positive, and she was tested, but the test results were somehow missed by people on the transplant team, and the transplant went forward.

... Because of the error, UPMC had decided on its own on May 6 to shut down the living donor kidney program.

Then, on May 9, when UPMC officials were discussing the situation with the U.S. Health Resources and Services Administration, they mutually decided to shut down the living donor liver program, too, said Michele Walton, a CMS spokeswoman.

Read the entire article.

I strongly feel there is much more going on here than a careless surgeon and nurse. Closing down these transplant programs for now is a major, major step that actually endangers patients on waiting lists. As per an anonymous comment received in my aforementioned May 25 post (link to full comment):

I surely hope they get this figured out soon as there are MANY lives on the line here. A very good friend of mine is on the list there and has myself as a willing paired donor and another mutual friend of ours as a perfect match donor that has one test to be done and then it is a go. With all of the testing that we both have had to go through - and by the way, myself now a second round as it has been more than a year since the original testing and no paired match has been located as of yet, that these things are known as soon as the tests are ran. I would have to agree that this must be beyond human error.

... This needs to be addressed and corrected like YESTERDAY. We have many out their literally dying on the lists.

I was also cited as follows later in the Post Gazette article:

... Dr. Silverstein and other experts say the current electronic health records systems that highly wired hospitals like UPMC have in place routinely flag test results for everyone connected to a surgery to see.

But those systems have been known to cause the same kinds of errors they were designed to prevent over the old-fashioned paper records. [E.g., as per the FDA internal memo on HIT risk I described at this Aug. 2010 post; see tables 4 and 5 - ed.]

I do think the reliability of existing alerting systems has been over-represented. "Flagging" a test result awaiting someone to note the flag amidst a sea of screens, icons and clutter, and setting off aviation-like stall alarms and other fail-safes that nobody can miss, are two different matters.

For the hundreds of millions of dollars spent on health IT by organizations like this, and the hype proffered about this technology, events such as the post-facto discovery of a tainted transplanted organ should truly be considered "cybernetic 'never' events."

One might also wonder if the informational issues, whatever their source, occurred more than once: that is, if prior transplant recipients who participated in these programs need to be checked for tainted organs.

That the Post-Gazette article was published on the one-year-to-the-day "anniversary" of my own mother being cybernetically turned into a train wreck due to the toxic effects of HIT -- in an ED where I once worked in the paper era where I do not recall EOT mistakes of the kind that nearly killed my mother ever happening -- is ironic.

Finally:

If health IT is indeed implicated in the UPMC error, and if UPMC knew of system unreliabilities that could have caused the clinical errors, both patients and affected clinicians can likely raise charges of criminal negligence on the part of those responsible for these IT systems.

Politics and an overall 'lawlessness' (per Hoffman & Podgurski) in the health IT sector needs to be replaced with the scientific and regulatory methods of medicine, such as intensive pre-marketing evaluations, clinical trials and post marketing surveillance of these systems.

Perhaps some jail time for the cavalier would remind people these are not toys, gaming computers, or slot machines, and that the subjects of health IT systems are human beings, not lab rats.

-- SS

Addendum May 27, 2011:

A reader reminded me of my 2009 post "UPMC as Proving Ground for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?"

-- SS

Twelve Hour Health IT "Glitch" at Allegheny General Hospital - But Patients Unaffected, Of Course...

At "Transplant Team at Univ. of Pittsburgh Medical Center Missed Hepatitis Result" I wrote about a kidney transplant gone bad at UPMC that may have been due to a computer "glitch."

Now Allegheny General Hospital in Pittsburgh has suffered a "glitch" that shut down their entire health IT system for approximately 12 hours:

Allegheny General Hospital's records system back online

By Pittsburgh Tribune-Review
Wednesday, May 25, 2011
Last updated: 10:26 pm

Allegheny General Hospital's electronic medical records system was online Wednesday afternoon after a morning shutdown caused by a glitch in a vendor's computer software, a spokesman [Dan Laurent] said.

... The hospital's system underwent a routine upgrade during the weekend, Laurent said. Staff shut down the system about 5 a.m. Wednesday after noticing it was running too slow. New Jersey-based software vendor Allscripts made repairs, and the system was online by 5 p.m., he said.

One might think the vendors of mission critical hospital systems would check their upgrades better before roll out to hospitals teeming with real, live, sick patients.

Of course, patient care was unaffected. It never is when a "glitch" occurs, despite the massive inconvenience to doctors who actually have patients to care for, and the need for backloading paper data - with inherent opportunity for error - after the computer system is resuscitated.

At a Jan. 2011 post "Orderless in Seattle: Software glitch shuts down Swedish Medical Center's medical-records system" I observed:

There's that word "glitch" again that I see so frequently in the health IT sector when a system suffers a major crash that could harm patients. Why do we not call it a "glitch" when a doctor amputates the wrong body part, or kills someone? ... the shutdown likely affected about 600 providers, 2,500 staffers and perhaps up to 2,000 patients, but no safety problems were reported.

As I've noted at this blog before, it is peculiar how such "glitches" never seem to produce safety problems, or even acknowledgments of increased risk.

Same in this Allegheny General Hospital case:

... [spokesman] Dan Laurent said staffers took drug and lab orders on paper forms, and that patient care was not affected by the shutdown.

If patient care is never affected by shutdowns even as long as an entire working day, one wonders why the tens or hundreds of millions of dollars spent on these systems is needed in the first place...

I have a solution.

Cloud computing!

-- SS

Transplant Team at UPMC Missed Hepatitis Result - Suspicious for Health IT Failure?

A story suspicious for EMR malfunction appeared in the Pittsburgh Post Gazette:

Transplant team missed hepatitis result

Kidney donor, recipient unaware of virus' presence

Saturday, May 21, 2011

By Sean D. Hamill and Jonathan D. Silver, Pittsburgh Post-Gazette

The living donor and recipient of a recently flawed kidney transplant at UPMC are a couple who did not know that the donor, a woman, was hepatitis C positive, and didn't find out until after the kidney was transplanted into the man [which stunningly implies the entire transplant team didn't know, either - ed.], sources told the Pittsburgh Post-Gazette.

The woman was tested for hepatitis C prior to surgery, and the results showed she was positive for the virus, but the two people on the transplant team who should have checked the results and stopped the transplant, failed to do so, sources also said.

[Or was the data missing? Something is not right here. What, exactly, was checked, and what, exactly, was not checked? Did they also check for other infectious diseases such as HIV, hepatitis A, B, etc., or did they "miss" them, too? See below - ed.]

On May 11, two days after the transplant became public, a board member said Elizabeth Concordia, UPMC's executive vice president, gave a 20-minute presentation to the hospital system's board of directors during its regular meeting and told them that the positive test was missed during 12 steps throughout the process.

The failure to act on the positive test was so serious that it was considered a "systemic" problem in the way the protocols failed in this one case, Ms. Concordia said, according to the board member, and that's why UPMC voluntarily shut down its living donor transplant program May 6. [A rather extreme measure - ed.] The program will remain closed until an investigation is completed and new protocols can be drawn up to prevent the error from occurring again.

The hospital system would not confirm these details or release a copy of its internal protocols that would show who on the transplant team should have reviewed the test results.

Because of the current federal, state, county and internal investigations, "I don't think it's appropriate for us to say right now what the protocols are," said UPMC spokeswoman Jennifer Yates. "But we are reviewing everything to ensure it is not a systemic problem" beyond this one case.

Ms. Yates said UPMC has done 975 living donor kidney transplants since 1988 and this is the only known case of a hepatitis C positive donor kidney being transplanted into someone who was hepatitis C negative.

The error was discovered by UPMC, which self-reported it to the Centers for Medicare and Medicaid Services (CMS), and it was not related to a review by CMS that was "coincidentally" ongoing at the time of the discovery at Children's Hospital of Pittsburgh of UPMC, a CMS spokeswoman said.

This hepatitis-C fiasco to my eye seems a likely case of IT error of omission or transmission (EOT, see Tables 4 and 5 at the FDA internal memo I cached at http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf).

It's inconceivable to me experienced transplant personnel, used to checking for data such as HIV, hepatitis status of donor and recipient, and other blood abnormalities would just miss this.

I would believe the hepatitis status, e.g., Hepatitis A, B, C, would be presented on the same screen. (If not, that's a design flaw itself.) That the Hep-C value could be missed by more than one person [possibly many people; see addendum below -ed.] seems very unlikely - even if the presentation screen(s) were cryptic and poorly organized.

A more plausible explanation to me is that a positive result simply wasn't present at the time when it was needed, e.g., due to a Laboratory Information System (LIS)-Hospital Information System (HIS) interface problem, or a HIS data erasure or misidentification error after the data was correctly received.

Another issue:

For the hundreds of millions of dollars spent on computers at this medical center, I wonder why their "system" in critical areas such as transplantation (as it would appear from the reports) is entirely dependent on two people looking at data.

After all, the IT is "supposed" to reduce error by infallibly calling attention to critical abnormalities such as this. The EMR alerting systems should have been going off like cockpit stall warnings at the data combination of "transplant" and "hepatitis C". That's not rocket science.

This further supports my hypothesis of a health IT malfunction, as does what I read about their "shutting down the living donor transplant program" for now - an extreme measure if this medical error were merely the result of a person or persons simply forgetting to check a data screen or sheet.

More generally, in a nutshell: commercial health IT from the current sellers is a fiasco. It alone among medical devices is unregulated under the FD&C Act even though FDA admits it is a medical device, it is unsafe, the literature shows its benefits grossly exaggerated, it probably cannot be made to work considering the current HIT "ecosystem" and its pathologies and incompetents, and has only captured the market through the purveyors "controlling the channel" of information and memes through their massive trade association HIMSS and political connections to HHS.

Think tobacco circa 1940's-1950's.

Yet UPMC could get away with this debacle scot-free:

Despite the way it occurred, UPMC will probably not be found in violation of any federal guidelines for the failure of the transplant team to review the positive hepatitis C test [or failure of the health IT system to properly transmit it, if that is indeed what occurred - ed.]

That's because while current guidelines from the United Network for Organ Sharing, the organization that oversees the nation's transplant centers and could suspend or shut a program down for deficiencies, do cover deceased donor transplants, they do not specifically cover living donor transplants, except in a limited way.

Emily Blumberg, an infectious disease specialist at the University of Pennsylvania, said that it is because live donations are still a relatively new medical advancement compared to cadaver donations.

"What has happened is that live donations in the United States have really taken off in the last decade, and there's only been a push to standardize live donation processes recently," said Dr. Blumberg.

In other words you're supposed to test dead people and their organs for disease before transplanting them, but live people get a pass? This is the height of absurdity.

One of the factors driving the push to finally address guidelines for living donor transplants is the rapid emergence of so-called paired kidney donation networks. In the networks, a willing living donor, who isn't a match to a friend or relative who needs a kidney, gives their kidney to someone else in the network. That recipient then has a friend or relative give a kidney to someone else, and so on.

Over the last five years, the rise of such networks have allowed hundreds of people to get kidney transplants from people they previously did not know, including a chain involving 32 donors and recipients -- 16 of whom got new kidneys -- that UPMC was part of earlier this year.

"Everybody is [testing for viruses] but it would be helpful if we could all be doing it the same way -- especially with paired donation networks," said Dr. Blumberg, who also chairs UNOS's disease transmission advisory committee.

This seems a smokescreen for this error. Missing a positive hepatitis C test has nothing to do in my mind with "everyone testing for viruses in the same way." The issue is being aware of the results.

Through that committee, UNOS is now beginning to craft new guidelines that are specific to live donation transplants. A conference in July in Baltimore that Dr. Blumberg is helping to organize will act as a public forum on the proposed new guidelines that will address everything from which viruses should be tested for, to which tests should be used, to how the results are communicated and other issues.

Non-communication of results will surely be forbidden.

The guidelines that do exist now don't spell out how information about a test is to be conveyed and confirmed by people on the transplant team, which are protocols that are left to each individual hospital to establish.

This is entirely absurd. "Protocols" are needed to check the most fundamental of tests in a mission critical medical area? Why does this process have to be "spelled out?" In other areas such as blood transfusion, isn't the precess of someone actually looking at test results very straightforward? I did it as a medical student....

Those same guidelines -- which were written for the more common deceased donor transplants -- also don't explicitly require testing of living donor organs for viruses like hepatitis C, though, as a rule, transplant centers like UPMC do so anyway. "I can tell you every transplant center in the country already screens donors for things like hepatitis C or other infections that would affect our use of that organ," Dr. Blumberg said.

That's great, as long as the information doesn't end up in '/dev/null', a.k.a. the bit bucket.

The rest of the Gazette article discusses the obvious regarding a simple issue of testing and reporting prior to sticking an organ into someone else's body.

I believe if this incident was indeed related to a computer error:

• UPMC needs to reveal this publicly ASAP per Joint Commission Safety Standards, as similar flaws could affect other medical centers (such flaws that cause intermittent data erasure are known to exist; see Dr. Jon Patrick's study here on a Cerner system, for example.)

• Repeats of episodes like this could reflect criminal negligence (not of clinicians, but of the administration for installing faulty medical devices), or may already represent criminal negligence if the health IT systems in use were known to have bugs causing intermittent data loss.

-- SS

Addendum May 25, 2011:

It occurs to me that hepatitis is a rather routine type of lab test.

Everyone who looked at the electronic chart, usually a cornucopia of people in an academic medical center, had opportunity to review tests like that. They range from medical students, to interns and residents, to fellows to attendings, nurses, and other allied health professionals, not just a few specific people on the transplant team.

In my mind the most likely explanation for so many people missing such a crucial piece of data is that it was simply not there.

-- SS

Addendum May 27, 2011:

A reader reminded me of my 2009 post "UPMC as Proving Ground for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?", where UPMC made claims it was a "proving ground" for experimental health IT development.

-- SS

Key lesson from the NPfIT - The Tony Collins Blog

ComputerWorldUK.com

Key lesson from the NPfIT - The Tony Collins Blog

Listening to critics is critical to the success of big projects. But has this lesson been learnt?

Published 07:56, 20 May 11

A US doctor Scot Silverstein, who has an expertise in clinical IT design, says of the NAO report on the NPfIT that the initials should stand for: "National Programme of Failed IT.�

He says on the blog Health Care Renewal:

"Perhaps the NPfIT (National Programme for IT in the NHS) should be renamed the "National Programme of Failed IT in the NHS." No new acronym will be needed.

Read the entire ComputerWorldUK piece by Tony Collins. Some of the excuses and rationalizations described during this programme are simply stunning.

This idea, though, I find fascinating:

One of the lessons that emerges from disastrous business decisions, as recorded on the excellent BBC2 series "Business Nightmares" with Evan Davis, is that expensive new ideas should be tested, and repeatedly tested, by the harshest critics of those ideas.

-- SS

NPfIT: National Programme of Failed IT in the NHS

I have a suggestion for the Queen:

Perhaps the NPfIT (National Programme for IT in the NHS) should be renamed the "National Programme of Failed IT in the NHS."

No new acronym will be needed.

For this pleasure, the UK has spent upwards of �13 billion.

Of course, we as the progeny of the UK are going down the same path, surely soon to have a "National Program for Failed IT in the US." Ours will be a bit more expensive, unfortunately.

Excerpts from the US and UK press (read the entire pieces at the links):

http://online.wsj.com/article/SB10001424052748703421204576330691233267966.html
Wall Street Journal
Auditor Blasts UK HIT
BY STEN STOVALL
LONDON

The billions of pounds spent so far on England's much-delayed electronic patient record system within the National Health Service have been poorly used and the project urgently needs to be reassessed to ensure taxpayers get value for their money, the U.K.'s National Audit Office said Wednesday. A report released by the independent body concludes that the �2.7 billion spent on the records systems so far "does not represent value for money."


http://www.dailymail.co.uk/health/article-1388224/NHS-IT-project-cost-billions-delivering-ANY-benefits.html
Dailymail.co.uk
NHS IT system 'has cost billions without delivering ANY benefits'
By Sophie Borland
18th May 2011

Health Minister damns project as 'expensive farce'

The NHS� controversial project to computerise all patient records has cost billions of pounds without delivering any benefits, according to a damning report.

It warns the project is running years behind schedule and will probably never happen.

The �11 billion scheme, launched under Labour in 2002, was meant to create a central computer database of all patient records which could be easily be accessed by GPs and hospitals.

But from the outset it has been hit with technical glitches and arguments between the companies installing the systems.

The scheme has also been heavily criticised by leading doctors and privacy campaigners who warned patients� personal details would be vulnerable if stored on a database that could be easily accessed by thousands of NHS staff.

... The project was meant to be completed last year but the report warned that it was unlikely to be finished even by 2016, when the contract with one of the main firms installing the system expires.

So far only a few hospitals across the country have installed the new system � and there have been widespread problems.

Doctors have said it is too slow to use during busy clinics and other staff have reported the system suddenly crashing.

Ministers last night described the project as an �expensive farce� and demanded it was scrapped immediately.


http://www.computerworlduk.com/news/public-sector/3280340/official-failed-nhs-national-it-programme-has-no-chance-of-delivering-value-for-money/
Computerworld UK
Official: Failed NHS National IT programme has no chance of delivering value for money
Time to turn off the life support machine?
By Leo King
Published 00:02, 18 May 11

The NHS National Programme for IT, which is now budgeted at �11.4 billion, has no chance of delivering value for money and has failed on all of its crucial elements.

That is the verdict of a sharp report, compiled by the National Audit Office, that the prime minister has publicly insisted on assessing before any more deals are signed with suppliers. The report will be followed by Public Accounts Committee hearings and a Treasury report, which will also precede any signature.

National audit of the �11.4bn, 10-year UK program to automate all NHS patient records concludes "the project has not been value for money for the Dept of Health."


http://www.bbc.co.uk/news/health-13430375
BBC News
�7bn NHS electronic records 'achieving little' for patients
By Nick Triggle Health correspondent

Patients are getting "precious little" from the NHS electronic care records system in England, a watchdog says.

The �7bn system to replace paper files is falling further behind schedule and in places where it has been introduced it is not working as it should.

The National Audit Office also said some patients would not even get one as large chunks of the NHS had pulled out.

In conclusion, the NAO said the system was not providing value for money - something the government rejected.

Electronic care records are the key part of the overall �11.4bn NHS IT project.

The scheme was launched in 2002 with the aim of revolutionising the way the health service uses technology and also includes developments such as digital x-rays and fast internet connections. It is the third time the NAO has looked at electronic records - and each time the findings have been more damning.


http://www.guardian.co.uk/society/2011/may/18/government-urged-to-abandon-nhs-it-programme
The Guardian
Government urged to abandon NHS IT programme
Polly Curtis, Whitehall correspondent
guardian.co.uk, Wednesday 18 May 2011 12.03 BST

The government is coming under increasing pressure to abandon plans for a new NHS patient record system after the official spending watchdog said the scheme was very likely to waste another �4.3bn in the next four years.

The original aim of the �11.4bn NHS IT programme � to install a patient record database accessible from any point in the NHS in England by 2015 � will fail, the National Audit Office (NAO) warned.

The �2.7bn spent so far on the system has not been value for money, the watchdog said, adding it had no confidence that the remaining �4.3bn would be any better spent.

The nine-year-old project � the biggest civilian IT scheme attempted � has been in disarray since it missed its first deadlines in 2007. While its ambitions have been downgraded in recent years, the bill from the suppliers has remained largely unchanged, the report said.

MPs appealed for the remaining contracts to be abandoned to prevent the �4.3bn from going to waste. It amounts to more than one-fifth of the �20bn efficiencies the NHS is attempting to achieve.

I think it fair to say the UK has been massively fleeced and abused by its suppliers, consultants and health IT pundits.

The people of the UK have paid for this boondoggle. They should think of it as a form of taxation without representation, an abuse of their rights.

Perhaps they can learn a valuable lesson from this document:

The Declaration of Independence of the United States

Truth brings freedom.

-- SS

How One Hospital's EMRs and the "Experts" Who Designed, Acquired, Implemented And Used Them Ruined Mother's Day

This post is a personal account of a disastrous encounter with healthcare information technology (HIT) by my own mother. This "as it happened" account should put an end to doubts as to the toxic effects that poorly designed and implemented health IT can have on medical care, even on relatively basic issues such as tracking of a mere five common medications.

Today is Mother's Day.

I weep.

It's almost one year to the day when my mother suffered severe and now clearly irrecoverable cardiac and brain injuries due to an EMR-related catastrophic blunder in the ED of a large hospital.

She spent the entire night last night in an agitated delirium, which is occurring more often now, with me, her son, tending to her needs. Not even strong sedatives helped much. It is only now, this morning at 9:30 AM, that she has finally drifted off to sleep, giving me the time to write this.

To the (ir)responsible people at the hospital, I offer my sincerest ingratitude for what you did to my mother through stupidity. Ignoring my confidential April 2010 warning letter to the CEO and CMO about my observations of your organization's EHR deficiencies did not ingratiate me to your organizational culture, either.

Yet I hope your mothers are healthy and responsive to your gifts and appreciation on this day. I honestly do.

I would not wish what my mother went through (cerebellar hemorrhage) on anyone.

Here's a sampling of how such errors occur due to the toxicity of EHR's:

My mother was placed on a medication, Sotalol Hydrochloride, by this hospital's cardiologists in appx. 2001 to prevent atrial fibrillation.

An ED visit of April 2010 shows Sotalol as a "current medication" (as did multiple ED and inpatient charts dating back almost a decade):

From the ED EHR of April 15, 2010 in an admission for abdominal pain from rectal stricture, resulting in an anoplasty (widening) as an elective outpatient surgical procedure a few days later:

ED EHR of April 15, 2010

CURRENT MEDICATIONS

1) Cozaar: 25 milligram(s) PO Daily. [For high blood pressure - ed.]
2) Albuterol: unknown dose. [For bronchitis - ed.]
3) Restoril: 30 milligram(s) PO Daily. [Sleeping pill - ed.]
4) Humulin N: 10 units in am,8 units in pm. [Insulin - ed.]
5) Sotalol Hydrochloride: 120 milligram(s) PO Every 12 hours. [For heart rhythm, see here - ed.]

PAST MEDICAL HISTORY

MEDICAL HISTORY: Hernia NOS , Atrial Fibrillation [a dangerous heart rhythm that Sotalol prevents - ed.], DMII Wo Cmp Nt ST Uncntr [diabetes - ed], Bronchitis, Urinary Tract Infection NOS, Hypertension.

This is not exactly a complex or taxing medications list or medical history.

Now, from the ED EHR of May 19, 2010, after a Transient Ischemic Attack with temporary slurred speech (aphasia) and narrowed left carotid artery identified as the culprit:

ED EHR of May 19, 2010

CURRENT MEDICATIONS

1) Albuterol: unknown dose.
2) Humulin N: 10 units in am,8 units in pm.
3) Cozaar: 25 milligram(s) PO Daily.
4) Restoril: 30 milligram(s) PO Daily.
5) Atrovent HFA

[Note that something important's missing - the critical heart rhythm maintaining medication, Sotalol. It's simply gone - de-listed - even though WE WERE ASKED on May 19 in the ED if she still took it based on the computer's current meds listing of April 2010, and replied "yes." It then somehow disappeared ... perhaps due to a mission hostile user interface, or quality issues analogous to these ED EHR observations from Down Under? - ed.]

PAST MEDICAL HISTORY

MEDICAL HISTORY: Hernia NOS , Atrial Fibrillation, DMII Wo Cmp Nt ST Uncntr, Bronchitis, Urinary Tract Infection NOS, Hypertension.

SURGICAL HISTORY: anaplasty [misspelling in the original; errors like this make record searching and data analyses a challenge. "Anaplasty" and "anoplasty" are quite different. But what's a little EHR error among friends? - ed.]

PSYCHIATRIC HISTORY: No previous psychiatric history.

SOCIAL HISTORY: Denies alcohol abuse, denies tobacco abuse.

MEDICAL HISTORY: [Obviously repetitious of the above, but this is exactly how the record appears - ed.] Hernia NOS, Atrial Fibrillation, Dmii Wo Cmp Nt St Uncntr, Bronchitis NOS, Urin Tract Infection NOS, Hypertension, bronchiectasis, TGA in 88, post-herpetic neuralgia, possible WPW variant.

SOCIAL HISTORY: Denies alcohol abuse, denies tobacco abuse, lives alone with son nearby. [Also duplicative; a little cut 'n paste action? - ed.]

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

Note that the duplicate versions of MEDICAL HISTORY and SOCIAL HISTORY at the bottom contain critical information not in the versions at the top, such as "possible WPW variant" and "lives alone with son nearby."

WPW syndrome (Wolff-Parkinson-White) is a syndrome that predisposes to heart rhythm disturbances such as supraventricular tachycardia (SVT) and atrial fibrillation. I offered that history to ED staff as a reason my mother took Sotalol. I also offered that I once had the WPW syndrome myself, and had recurrent episodes of both SVT and atrial fibrillation, until intervention via the 'catheter ablation' technique in the mid 1990's. The "WPW variant" made it to her chart. The medication did not.

This ED EHR report is a major information presentation faux pas, showing sloppy report generation and poor presentation of information, since people in a hurry -- such as in an ED, or in an ICU where my mother was admitted -- may not scan the duplicate versions below for critical data not in the top version. The repetition with added items in the lower-down versions is inexcusable.

This is the type of IT work done by amateurs. In fact the shabby ED EHR output could be considered an accident of omission waiting to happen. I covered this type of flaw here: http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and.html .

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

So what meds actually were ordered after she left the ED and entered the ICU?

These:

Click to enlarge. Note the remarkable resemblance - or should I say identicality - to the 5/19/10 ED EHR medication list above. These were then entered into the floor CPOE system.

No Sotalol.

Several days later, after my mother was transferred out of ICU to the neuro floor in prep for a carotid stenting, my mother went into uncontrolled atrial fibrillation. In front of my eyes at around dinnertime. Sotalol has a half life of just about 12 hours. After a few days of missing it, it's effectively gone, at a level so low in the blood as to be ineffective.

I immediately asked nursing to call the physician, and asked how this was even possible on Sotalol. All I got back was a puzzled look.

Sotalol had never been ordered.

Long story short, in correcting the iatrogenic atrial fibrillation (the arrhythmia itself a stroke risk), Sotalol was restarted and IV heparin and electrical cardioversion (shock to the chest) were employed.

While initially successful in restoring normal heart rhythm, the IV heparin then precipitated a massive cerebellar hemorrhage around 2 AM the next morning (in an area of the brain entirely different from the cerebral language center supplied by the carotid). IV heparin is a dangerous drug you especially want to avoid in the elderly.

In what I thought might be her last words to me, all my mother could say when I arrived as they were taking her for surgery was a very agitated and frightened-out-of-her-wits "Scot-headache-headache-headache-I'm sick-I'm sick-I'm sick." The headache pain from the bleed must have been absolutely excruciating and horrendous.

She had the pallor of death about her.

The sheer horror of that moment, seeing my mother like that, sticks with me even though I am a physician.

Her CT looked dreadful, much like the stock image below:

Click to enlarge. When I saw her CT scan, I prepared to say my goodbyes.

Emergency craniotomy (brain surgery) was then performed by a neurosurgeon to save her life, followed by months of medical complications and agitated delirium resistant to most medications.

The brainstem sits anterior to the cerebellum, and brainstem compression from the bleed caused paralysis of the muscles of swallowing. A surgically placed stomach feeding tube through the abdominal wall was thus required, which in her delirium she yanked out, thus forcing total parenteral nutrition (TPN) via a central (deep) IV line until the site healed. (She was lucky she did not do herself a major injury by pulling the through-the-abdomen gastric feeding tube, which should have been far better protected with a delirious patient.)

The first ingredient I noted in the initial TPN bag was a medication my mother was allergic to, famotidine, but another EMR defect I uncovered prevented the clinicians from realizing this. It was only my personal knowledge that prevented administration. I ended up filing my own FDA MAUDE report on this EHR defect...to my knowledge the hospital did not, and has not.

The complications of the bleed and craniotomy surgery also forced the re-started Sotalol to be discontinued, as bleeds in the head adversely affect the heart's electrical intervals, and a drug like Sotalol can kill under those conditions (e.g., see Torsade de Pointes).

The forced discontinuation of Sotalol resulted once again in sudden return of atrial fibrillation that is now permanent. Correction or even appropriate anti-stroke treatment would require anticoagulation such as heparin and coumadin, and these are contraindicated due to the bleed.

My mother has been painted into a very bad corner, with irreparable cardiac injury putting her at increased stroke risk, and a severely damaged brain that has resulted in her being an invalid who frequently is in an agitated delirium, and/or no longer recognizes her own son. While her swallowing returned after several months, her mind never recovered.

In effect, the EHR toxicity caused the following personnel (at the very least) to miss my mother's Sotalol de-listing, which apparently propagated from ED to ICU to floor due to lack of any discernible fail-safes or meaningful reconciliation:

• ED triage nurse
• ED physician [who stunningly notes in the record "She had a prior history of atrial fibrillation. However, per her report this has resolved and she is not currently taking any anticoagulation." A true statement - except he forgets to address the first-year medical student-level question: "atrial fibrillation resolved - how?" The answer that I'd related to him was "her atrial fibrillation resolved on Sotalol"; Sotalol is a take-for-life drug. On the NIH page about Sotalol: "Sotalol controls your condition but does not cure it. Continue to take Sotalol even if you feel well. Do not stop taking sotalol without talking to your doctor."]
  
• ED staff nurse
• Two neuro-interventionalist physicians
• Multiple medical residents
• ICU physicians
• ICU nurses and staff
• Floor nurses and physicians after transfer from ICU to neuro floor

I further observe: it is nearly unbelievable to me that not one person out of all the clinicians who saw my mother during this admission, even when transferring her from ED to ICU to floor, detected this fundamental, major medical error via ED and inpatient histories dating back almost a decade. Is interfacing between the floor and ED EHRs an issue? Are the EHR's too mission hostile for busy clinicians to use? What in hell was going on here?

You'd think that for the $25+ million dollars spent by this organization on HIT, the IT could have included failsafe features on meds and other life-critical data. Has the computer become deified in this culture; its outputs, a Testament that nobody challenges?

I tragically note that one Sotalol pill, worth perhaps a few cents, probably could have prevented the catastrophe if the error had been detected even as late as floor transfer from ICU.

To add insult to injury, the following was added to the ICU H&P sheet some time after the catastrophic brain bleed:

Click to enlarge. A very unwelcome discovery when I asked the neuro floor RN to see the chart a few weeks after the accident. Entry #8 was not present the day the Sotalol error was realized; I was shown the chart at that time.

Undated, untimed additions to medical charts with illegible signatures violate Joint Commission, Medicare and State Medical Professional standards of conduct, among others.

I leave it to the reader as to why this chart alteration might have been attempted.

When I saw this, needless to say, I was very upset. I demanded an immediate printout of the eMAR (electronic medication administration record), lest that be altered as well. The eMAR fortunately showed Sotalol had indeed not been ordered prior to the onset of the A. fib. I do not know what it might have showed a week ... or a month ... later, had I not been a nosy and medicine/medical informatics-educated patient advocate for my mother.

As I did not have my Power of Attorney documents for my mother with me, I demanded the eMAR printout and copy of the altered ICU H&P be sealed in an envelope whose glue flap I signed, to be held until I retrieved my POA documents from the nearby bank allowing me to take custody of copies of both these documents.

This is how toxic these wonderful non-FDA approved or vetted, Obama HITECH-pushed Cybernetic Revolutionizers of Medicine can be, when not "done well."

It should be noted that further errors of this type at this hospital system would very likely amount to criminal negligence.

Happy Mother's Day.

-- SS

Toward Meaningful Usability: Five Keys to Creating Physician- Centric CPOE (Wait - The Terms "Safety", "Risk" and "Error" Are Missing)

In a 2011 "White Paper" from a company PatientKeeper entitled "Toward Meaningful Usability: Five Keys to Creating Physician-Centric CPOE" (PDF), an organization whose motto is "Enabling Physicians to Focus on Patients ... Not Technology", I again note a common phenomenon.

Certain verboten terms are absent.

What might those terms be? More on that in a moment...

They speak of "the failure of CPOE":

The failure of CPOE to date can be attributed to many factors that ultimately lead to a lack of physician adoption. CPOE systems have historically been designed to support the workflow of the departments responsible for fulfilling the orders rather than the physician workflow around entering orders. As a result, entering orders electronically can take significantly longer than written or verbal orders and often requires the physician to change the way they currently practice medicine.

That's a problem, considering the following observation (paraphrased from a "why-pharma-fails" post at this link):

"The machine was made for Clinicians, not Clinicians for the Machine."

But still, words are missing from the White Paper. Again, more on that in a moment.

... Hospitals often purchase CPOE on the premise that standardization of care through evidence-based order sets is the optimal way to improve patient care delivery and reduce healthcare costs. In fact, most standardized care is not
supported by evidence so spending months or even years to achieve order set consensus only serves to delay implementation and use while increasing the overall cost of the order entry system.

Well, yes, but where are those missing words?

Most CPOE systems expose physicians to all clinical alerts regardless of severity.
The preponderance of these alerts disrupts the ordering process, leads to alert fatigue, and results in frustration on the part of the physician. Finally, the number of available workstations, including those on the hospital floors and in patient rooms, is limited, and physicians may have to wait in queue to enter their orders. This may lead to an increase in verbal orders from the physician to the nurse, pharmacist, etc. as well as frustration with a process that requires more physician time than simple pen and paper.

There must be a lot of frustrated doctors out there. Still, the shibboleth terms are missing.

Cited are the usual KOL's:

1 D. W. Bates, J. M. Teich, J. Lee et al., �The Impact of Computerized Physician Order Entry on Medication Error Prevention,� Journal of the American Medical Informatics Association 6 (July/August 1999): 13�21.
2 D. W. Bates and A. A. Gawande, �Improving Safety with Information Technology,� New England Journal of Medicine 348 (June 19, 2003): 2526�34.
3 Jason Hess, KLAS Enterprises (Orem, Utah), �Are We There Yet? Getting to Meaningful CPOE Use�, July 13, 2010

Still no mention of the missing critical terms.

The next generation of CPOE solutions must ultimately save physicians time, rather than simply being time-neutral. Otherwise, they will suffer the fate of most previous attempts to implement this required functionality � at the cost of improved patient care, better outcomes, and lost ARRA stimulus dollars.

In other words, the worst-case scenario is wasted promotional dollars and maintenance of the clinical status quo.

Still, key terms are missing.

What are those terms?

Here they are, the unaccounted-for outcomes of CPOE and its toxicity in its present form:

• Safety (as in, "reduction of")
  
• Risk (as in, "of injury, increased")
  
• Danger (as of, "putting patients in")
  
• Error (as in, "the outcome of toxic HIT")
  
• Harm (as in, "injury and death")
  

This was no mere White Paper. A more appropriate term might be a "Snow White" paper:

CPOE, An Enchanted Technology. Find the Prince!

Health IT, including dysfunctional and toxic CPOE, causes frustration among doctors. CPOE failure is merely "physician nonacceptance."

But the frustration among injured or dead patients and their families seems never to be mentioned or considered in this industry.

I pointed out that similar terms were missing from the PCAST (President�s Council of Advisors on Science and Technology) report on health IT at my Feb. 2011 post "Brief Comments on the PCAST Report on Health IT."

Shhhh!

-- SS

Mission Hostile Health IT Obstructs Physicians From Ordering Life Saving Drugs In Critical Emergency

"You should not have to work around something that is not in the way" - SS

This post can be considered Part 9 of my multi-part series on the mission hostile user experience presented by commercial healthcare IT.

Note: Part 1 is here, part 2 is here, part 3 is here, part 4 is here, part 5 is here, part 6 is here, and part 7 is here, and part 8 is here.

Special K� Red Berries is one of my favorite cereals.




In this context, however, "Special K Red Berries" is a metaphor for cerebral and other hemorrhages caused by health IT getting in the way -- actually obstructing -- physicians ordering emergency medications such as vitamin K given via the fastest route, intravenously.

A cerebral hemorrhage at post-mortem (obviously). Note the "red berry." Similarities in appearance to above cereal bowl ironic.

This EHR system has been deployed for approximately a half decade in a hospital I'll leave unnamed.

It is stunning to me that no clinician has apparently ever complained about the following informatics/relational database integrity "glitch" regarding a not-uncommon clinical scenario, over-anticoagulation (too much blood thinner). If they did complain, however, it would be criminally negligent if the following issue was not corrected.

Atrial fibrillation (Afib) is a heart rhythm disturbance that makes a person prone to throw blood clots from the heart and suffer strokes, and is treated in part by anticoagulant drugs such as heparin and coumadin.

Atrial fibrillation is a disorder found in about 2.2 million Americans. During atrial fibrillation, the heart's two small upper chambers (the atria) quiver instead of beating effectively. Blood isn't pumped completely out of them, so it may pool and clot. If a piece of a blood clot in the atria leaves the heart and becomes lodged in an artery in the brain, a stroke results. About 15 percent of strokes occur in people with atrial fibrillation. The likelihood of developing atrial fibrillation increases with age. Three to five percent of people over 65 have atrial fibrillation

A patient with Afib on coumadin was found to be over-anticoagulated, with a dangerously high INR value, greater than 5. This patient already had a history of a life threatening subdural hematoma (bleeding hemorrhage under the lining of the brain, potentially fatal) a few years prior.

This, the patient was at great risk of catastrophe.

The international normalized ratio (INR) test is a measure of the extrinsic pathway of blood coagulation. It is used to determine the clotting tendency of blood...A high INR level such as INR=5 indicates that there is a high chance of bleeding.

Vitamin K (Aquamephyton) reverses the blood-thinning effects of coumadin. It acts most quickly and is most effective when administered intravenously.

That is, if the computer, now mediating and regulating an increasing amount of healthcare operations, allows the physician to order it that way.

It takes perhaps 3 seconds to write an order such as "aquamephyton 10 mg IV STAT", and a minute or less for the order to be called down to pharmacy by a clerk.

The computer version of the same task worked a bit differently for a very ill patient:

A hospital resident physician, when told to order IV Aquamephyton for urgent administration to this over-anticoagulated patient with atrial fibrillation who had already suffered a subdural hematoma, could only order it subcutaneously due to computer restrictions.

A half-hour of investigation, IT experimentation and phone calls needed to be made to the attending physician and the pharmacy to override that limitation, while the patient lay at critically high risk for another life threatening bleed.

Here are actual de-identified screen shots displaying the mayhem:

Screen 1. Click to enlarge. The physician typed the partial search term "aquam" to locate "aquamephyton", but the order menu stated that "no matching entries found."

Screen 2. Click to enlarge. The physician as a guess then typed "aqua" (instead of "aquam") and the drug and dosing options are listed (but spelled wrong in 2 ways - "aquaAMEPHYTOIN" - which is why "aquam" failed to match anything).

Screenshot 3. Click to enlarge. The physician clicked on the drug to override the fixed options presented in the listing, but the IV route of administration was not available in the drop down box, nor could it be entered in any way.

Screenshot 4. Click to enlarge. Same as #3 but with dose "10 milligrams" filled in. Still no option for IV route on the drop down.

Screenshot 5. Click to enlarge. Continuing the doctor's waste of time and IT misadventure, the doctor typed in "aqu", which leads to the same options. Still no IV route available! Note that there is no automatic reference for the drug offered by the computer.

Screenshot 6. Click to enlarge. After consultation on phone with pharmacist, more time wasted, physician now typed in "phy" (part of the generic name for the drug, i.e., "phytonadione"). BINGO! More options are now available, that are continued on screenshot 7 after scrolling down.

Screenshot 7. Click to enlarge. Med list has been scrolled down. Finally, an IV option is located after a bit of wild goose chasing. ("IVPB" stands for intravenous piggyback). Why were these choices not available under the drug's brand name? It's the same drug!

I won't even go into the computational-linguistics and HCI backwardness of forcing clinicians to go on a distracting 'treasure hunt' through a list of permutations of drug doses and routes, or a menagerie of widgets for parameter specification, for each drug they order, as compared to more advanced methods of command entry. Such methods would have the computer (via the programmers) algorithmically do the bulk of the work. The concept of "parsing" seems alien to health IT vendors, who seem stuck in the paradigms of an earlier data processing era.

Screen shot 8. Physician typed in "vitamin K" and the same options appeared as with "phy." The computer response and administration options to the physician for any of these synonymous drug names should have been exactly the same (even with the "aquaamephytoin" misspelling, once the physician located the drug by luck).

The simple has been turned into the complex, with misspellings, delays and frustration, while a patient at great risk for literal red berries accumulating in his or her head lay in bad, waiting for treatment.

There are parallels between this "glitch" and glitches reported in a competitor's EHR reported by Dr. Jon Patrick in Australia at these links, e.g., regarding faulty data and linkages, user interface problems obstructing clinical work, etc.:

• Analysis of Cerner Problems Defined by ED Directors, http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=120&Itemid=116

• A study of an Enterprise Health information System, http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146

Several questions:

• Is this a configuration/formulary problem local to this organization, or is it a generalized problem with this system originating at the manufacturer? (I've personally reported health IT defects in this software I'd observed in hospitals to FDA's MAUDE database, discovering that the institution itself, whose officials I alerted to the problems, did not. An example of a possible systemic problem is in MAUDE here.)
  

• What other drugs are misspelled, and/or listed under different names with different (and incomplete) ordering options, with no easy and quick override?

• How did these errors get into the system, and why were they not corrected earlier?
  

• Were patients ever injured by this or other similar IT defects within this system?
  

• Is this the technology that will reduce errors and "revolutionize medicine"?
  

• Would you, the reader, want to be that patient waiting for the vitamin K or other critical drug while the doctors fritter away their time and energy on mission hostile computer systems?

Some day you or your family member might be.

-- SS

How Academic and Government "Anecdotes Are Not Data" Ideologues Kill People

I'm already receiving comments that, regarding Prof. Jon Patrick's detailed expos� of the dangers of ill-suited-for-purpose ED EHR's, Patrick's observations are:

... not really valid because they're not peer reviewed; they're just anecdotal.

Only an egghead could pen such words.

I always get hives immediately after eating strawberries. But without a scientifically controlled experiment with all the right peer review, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives.

I'd already written about anecdotalist refrains at my Mar. 7, 2011 post "Australian ED EHR Study: Putting the Lie to the Line "Your Evidence Is Anecdotal, Thus Worthless" Used by Eggheads, Fools and Gonifs." In that essay I cite Dr. Patrick himself on "anecdotal evidence", regarding which he hit the ball out of the Southern Hemisphere in an editorial in "Applied Clinical Informatics" entitled "The Validity of Personal Experiences in Evaluating HIT."

Aside from the fact that eggheads also don't seem to care about the issues of faulty peer review, especially in profitable biomedical sectors, such as at "The Lancet Emphasizes the Threats to the Academic Medical Mission" with its embedded links, and "Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?", there's this simple fact:

Public health catastrophe warnings from responsible sources don't need peer review, they need investigation.

Yes, there were those pesky, off-narrative journalistic reports that the Japanese nuclear reactors were not entirely safe, that Bernie Madoff was a fraud, that mortgages for everyone was not a good idea, that the O-rings couldn't stand sub-freezing temperatures, that the the foam that broke off the Columbia launch tank caused a danger, and that the Titanic didn't have enough lifeboats, but they weren't peer reviewed...so we ignored them. Saved us a lot of money, too.

-- SS

Addendum:

At my post "Real" Medical Informatics: What Does a Problem List of Typical Health IT Look Like, Part 2", I opined:

If the purpose of Medical Informatics is the improvement of healthcare (as opposed to career advancement of a small number of academics through publishing obscure articles about HIT benefits while ignoring downsides in rarified, echo-chamber peer reviewed journals), then:

• Who are the "real" medical informatics specialists, and;
  

• Who are the poseurs?

... researchers like Jon Patrick who address real-world issues of great import to patients on HIT risks, and further go public on the web with their work without the full blessings of some dusty journal (and those like Ross Koppel who also directly address the downsides, and others who make available to the public material such as on blogs like this and this, papers like this and sites like this) are the former.

Those who deem only "peer reviewed" articles worthy of daylight, and everything else - especially and particularly reports of downsides - "anecdotal" (the anecdotalists) are the latter.

I stand by this assertion.

Finally, I ask: at what point does ignoring work such as Prof. Patrick's, if patient harm is caused by the system he reviewed, constitute reckless endangerment and perhaps criminal negligence by hospital and government officials?

-- SS

Addendum Mar. 23:

As if on cue, this story appeared in the WSJ:

March 23, 2011

Japan Ignored Warning of Nuclear Vulnerability

TOKYO�Japanese regulators discussed in recent months the use of new cooling technologies at nuclear plants that could have lessened or prevented the disaster that struck this month when a tsunami wiped out the electricity at the stricken Fukushima Daiichi power facility.

However, they chose to ignore the vulnerability at existing reactors and instead focused on fixing the issue in future ones, government and corporate documents show. There was no serious discussion of retrofitting older plants with the alternative technology

I guess the "vulnerability reports" just weren't peer reviewed, therefore meaningless - or not reviewed by the "right" peers.

This sounds like our own FDA, ONC office and Institute of Medicine (via the Committee on Patient Safety and Health Information Technology), "choosing to ignore" health IT "vulnerabilities" (such as the aforementioned) and focusing on future issues such as comparative effectiveness research, "the common good", etc. instead.

I call this attitude "reckless endangerment" and hope plaintiff attorneys are paying close attention.

-- SS