ONC and Misdirection Regarding Mass Healthcare IT Failure

In my keynote address to the Health Informatics Society of Australia in Sydney recently, I cautioned attendees including those in government to be wary of healthcare IT hyper-enthusiast misdirection and logical fallacy (a.k.a. public relations).

In the LA Times story "Patient data outage exposes risks of electronic medical records" on the Cerner EHR outage I wrote of in my post "Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised" (the title, of course, being satirical), Jacob Reider, acting chief medical officer at the federal Office of the National Coordinator for Health Information Technology is quoted.  He said:

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

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

As comedian Scott Adams humorously noted regarding irrelevancy, a hundred dollars is a good price for a toaster, compared to buying a Ferrari.

Further, when you're the patient harmed or killed, or the victim is a family member, you really don't care how "rare" the outages are.

Airline crashes are "rare", too.   So, shall they just be tolerated as a "cost of doing business" and spun away?

(As I once wrote, the asteroid colliding with Earth that caused the extinction of the dinosaurs was a truly "rare" event.)

It seems absurd for me to have to point out that paper, unless there is a mass outbreak of use of disappearing ink, or locally hosted clinical IT, do not go blank en masse across multiple states and countries for any length of time, raising risk across multiple hospitals greatly, acutely and simultaneously.   Yet, I have to point out this obvious fact in the face of misdirection.

Locally hosted health IT, of course, can only cause "local" chart disappearances.  "Local" is a relative term, however, depending on HC organization size, as in the example of a Dec. 2011 regional University of Pittsburgh Medical Center (UPMC) 14-hour outage affecting thousands here.

Further, EHR's and other clinical IT, whether hosted locally or afar, had better offer truly major advantages, without major risks and disadvantages, over older medical records technologies before exposing large numbers of patients to an invasive IT industry and the largest unconsented human subjects experiment in history.

Unfortunately, those basic criteria are not yet apparent with today's systems (see for instance this reading list).

EHR's and other clinical IT, forming in reality an enterprise clinical resource management and clinician workflow control apparatus, have introduced new risk modes including mass chart theft (sometimes tens of thousands in the blink of an eye); also, mass chart disappearances as in this case - all not possible with paper.

At the very least, if hospitals want enterprise clinical resource management and clinician workflow control systems, these should not be relegated to a distant third party.  Patients are not guinea pigs upon whom to test the ASP software model ("software as a service") that, upon failure for any reason, threatens their lives.

Finally, these complications are a further example why this industry cannot go on without meaningful oversight.  The unprecedented special medical device regulatory accommodations must end.

-- SS

Vermont: Despite $70 million investment, health IT systems a long way from prime time - "Problems are appropriate"

Preliminary note:  This post is rich with hyperlinks.  At minimum I recommend opening them in another window and at least scanning their contents - SS

No surprises in this article, including an amorality alien to the healing professions, but common in technology circles:

Despite $70 million investment, health IT systems a long way from prime time
VTDigger.org
Andrew Nemethy
July 18, 2012

The state’s efforts to digitize the world of health information, a costly multi-year endeavor that is approaching a $70 million pricetag, got a lousy diagnosis Tuesday.

Instead of creating cost efficiency and improving payment flow to doctors and treatment for patients, it’s creating stress and a lot of headaches for physicians, according to both lawmakers and state officials overseeing the effort. [It's also creating increased risk for patients, a factor - the most crucial factor - rarely mentioned in articles such as this - ed.]

Money, of course, grows on trees, and physicians, hospitals and government have nothing better to do with $70 million than conduct experiments on patients with alpha and beta software ...

There's the usual excuses from the usual actors:

But Health Information Technology (HIT) coordinator Hunt Blair said that’s to be expected considering the difficulty of the “incredibly challenging” task of getting such disparate groups as doctors, hospitals, other health care providers, insurance companies, the state and federal government on the same digital page.

Let alone (per Social Informatics) the organizational and sociological challenges of implementing any new information or communications technology (ICT), that's somewhat akin to saying it's hard to get people to consume arsenic as an aphrodisiac.  Not mentioned is the deplorable state of health IT in terms of quality, safety, usability, unregulated nature etc.

“We’re talking about an extremely complex undertaking and I think it’s important to recognize the state of Vermont was way out in front,” Blair said.

“We’re on the bleeding edge,” he told a legislative Health Care Oversight Committee Tuesday at the Statehouse.

That prompted Sen. Claire Ayer, D-Addison, the panel’s chairwoman, to ask him to clarify if he meant “leading.”

He stuck with “bleeding.”

"Bleeding edge?"

Aside from the very poor choice of terms, this attitude is the polar opposite of the culture of "first, do no harm."  It is not a clinician's attitude.  It is an attitude of someone who seems to forget that patients are at the receiving end of the "bleeding edge" (which usually implies a rocky course) technology:

Bleeding edge technology is a category of technologies incorporating those so new that they could have a high risk of being unreliable and lead adopters to incur greater expense in order to make use of them.  The term bleeding edge was formed as an allusion to the similar terms "leading edge" and "cutting edge". It tends to imply even greater advancement, albeit at an increased risk of "metaphorically cutting until bleeding" because of the unreliability of the software or other technology.The phrase was originally coined in an article entitled "Rumors of the Future and the Digital Circus" by Jack Dale, published in Editor & Publisher Magazine, February 12, 1994.

Wonderful.

Considering the risks to patients, this claim brings to mind the definition I posted of the health IT Ddulite ("Luddite", the common canard against cautious doctors, with the first four letters reversed):

Ddulite:  Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures.

On the other hand, did critic VT Sen. Kevin Mullin read my Drexel website on health IT failure and mismanagement?

That doesn’t surprise Sen. Kevin Mullin, R-Rutland, who had tough questions about the state’s effort to oversee and promote use of electronic medical health records and a statewide health information exchange.

“I hear genuine frustration from providers who are spending time and resources trying to modernize and make their offices more efficient, and prepare for the future, and yet every one of them feels like they’ve been burned,” he said.

“Basically we’re not getting any results for these millions and millions of dollars that have been pumped into IT (information technology),” he said after the meeting.

“We should be a lot further along,” he said. “I just don’t think the leadership’s in place.”

He's on the right track, but I'm not sure Vermont (or any state government) really understands what levels of leadership are truly needed, e.g., as outlined by ONC a few years ago here.

More excuses:

... Mark Larson, commissioner of the Vermont Health Access Department and a former House representative from Burlington, oversees management of Vermont’s publicly funded health insurance programs and the effort on digital medical records and a new medical information exchange.

... Larson told lawmakers he hears the same message they do, that there’s “a lot of confusion in the field.” He said that is an inevitable part of the complex process.

“These are not systems where you just plug that in and they work perfectly on day one,” he said. “Problems are appropriate along the path to get where we want." [I note this is an implicit admission that experimentation is being performed - ed.]


“We just have to work through that,” he said.

"Problems are appropriate?"  ... Really?  In a mission critical field such as medicine?  That's a maddeningly reckless and cavalier ideology, to put it mildly.   In what other safety-critical domain would such a happy-go-lucky attitude that "problems are appropriate", outside of the laboratory, be tolerated? 

"We just have to work through that?" ... "Just work through that?"  Really?

That should be really easy,  just like the failed £12.7bn (~ US $20 billion) National Programme for IT (NPfIT) in the NHS, a program that went "Pffft" last year.

... Based on testimony Tuesday, the issues that medical practitioners and the industry face in digitizing information are familiar ones for anyone who deals with technology: Software that is problematic, digital files that don’t translate and can’t be read by other systems, lost time spent on technological issues that detract from what doctors are paid to do, which is treat their patients. [And create increased risk that leads to maimed or dead patients - ed.]

"Familiar to anyone who deals with technology?"  As in, say, mercantile/management computing that runs Walmart's stock inventory system, or the Post Office?  Is that an appeal to common practice of some type?  This brings to life my observation that there is an utter lack of recognition (either due to ignorance, or opportunism) that HIT systems are not business management systems that happen to be used by clinicians, they are virtual clinical tools (with all that implies) that happen to reside on computers.

How utterly amoral and alien to the ethics of medicine these attitudes are.  No regulation of the technology is in place.  No systematic postmarket surveillance of patient harm or death is conducted. 

Further, the literature on health IT is not entirely as optimistic and tolerant as the VT government.

Is the VT government aware of that literature?

Just a few specific examples - the National Research Council wrote that  "Current Approaches to U.S. Healthcare Information Technology are Insufficient", do not support clinician cognitive processes (then what, exactly, is health IT supposed to do?) and may result in harm. 

The ECRI Institute indicates health IT systems are among the top ten technology risks in healthcare.

Reports from the Joint Commission, FDA and AHRQ indicate that risk is known, but magnitude of risk unknown ("tip of the iceberg" per FDA).

A report from NIST indicates that usability is lacking and promotes "use error" (technology-promoted error, as opposed to "user error").

A report from IOM on safety of health IT states that:

... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”).

The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.

(Institute of Medicine, 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. PDF.  Washington, DC: The National Academies Press, pg. S-2.)

Human subjects protections?  Not needed here ... it's just one big, unconsented, happy $70 million medical experiment.

What is not mentioned, and either deliberately ignored or lost on these politicians, is the effects of this turmoil on patient care in terms of risk and adverse outcomes, and that being on the "bleeding edge" in this experimental technology is not desirable.  

Slow, skeptical and cautious approaches are essential.  Physician education on health IT risks and patient informed consent might be nice, too.

It seems mass social re-engineering experiments are fine, even if the consequences include wasted resources the healthcare delivery system can ill afford, physicians being distracted by major defects, and outcomes like baby deaths, adults suffocating at the bedside, and graveyards.

-- SS

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."

An Expensive Healthcare Computing Mistake: $1.5 Million

At my June 2011 post "Babies' deaths spotlight safety risks linked to computerized systems" I reported on a case (case #2) of an infant death in part attributed to HIT (PACS) interference in otherwise simple care processes.

In "Allen-Blake vs. Abington Memorial Hospital", a critical x-ray of a PICC (peripherally inserted central catheter) line placement allegedly was never read due to misdating.

The Allen-Blake case was settled 2/29/12 for $1.5 million, according to the public docket count 78 (link):

2/29/2012

Order

OF 2/28/12 OTT, J PROPOSED SETTLEMENT OF $1,500,000.00 APPROVED CC

That $1.5 million might have paid for a lot of other things, such as provision of better medical care through hiring/retention of more staff. The legal fees for defense incurred must also have been substantial, representing yet more precious healthcare capital down the proverbial drain.

Add cases like this to the "total cost of ownership" of health IT.

-- SS

Death at Birth: A Tragedy Caused by Overwork and Undertraining - and Technology

As a result of my recent post "Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients", a malpractice attorney, Patrick Malone in Washington, D.C., sent me a link to a tragic summary of a case his firm handled.

The story illustrates the toxic effects that health IT and other technology, especially when not "done well", can have on patient care.

I present it below with just a bit of comment, with permission of attorney Malone. Emphases also mine:

Death at Birth: A Tragedy Caused by Overwork and Undertraining

The Patrick Malone firm represented the family of Keren Kipoliongo, a baby girl who died in her mother’s womb just minutes before the successful Cesarean section delivery of her twin sister Gabrielle.

This tragedy occurred at Virginia Hospital Center in Arlington, Virginia in July 2008. At midnight one evening, Mrs. Kipoliongo and her husband presented to the labor and delivery unit at the hospital, as scheduled per their obstetrician’s instructions. The plan was to induce labor with the drug Pitocin (oxytocin) and monitor both babies during the labor with fetal heart monitors, to make sure they could withstand the contractions and be safely delivered by the normal vaginal route.

This was the first pregnancy for the couple, and they were excited about the prospects of having twins. They had set up their home in northern Virginia with a nursery with two cribs and two of everything else they would need.

The obstetrician whom Mrs. Kipoliongo had seen regularly throughout her pregnancy checked them into the L&D unit and then went to sleep in the doctors’ lounge. He instructed the nurse and a resident physician (doctor in training) to call him if needed.

Mrs. Kipoliongo was left alone for large stretches through the night. It wasn’t until a nursing shift change at 7 a.m. that she started to get close attention from the nurses. By that time, baby Keren was in bad shape as shown by fetal monitor patterns in which her heart beat was slowing ominously with the mother’s contractions. She had already shown throughout the overnight period a flattening or lack of variability from beat to beat. (The flattening of the heart rate often means the baby is not getting enough oxygen.) [Why was this not noted and acted upon promptly? Read on - ed.]

They finally brought the obstetrician in, and he decided around 8:15 a.m. to do a Cesarean section. Baby Keren was still alive at that point. Unfortunately she died some time over the next hour, because when the doctor finally cut into the mother’s womb after 9 a.m., he found that she was dead, with the umbilical cord wrapped tightly around her neck.

When our law firm investigated what had happened on behalf of the family, we found several disturbing facts. These included:

• Despite the lack of reassuring signs on baby Keren’s heartbeat, the nurses failed to do any of a number of standard things that can improve the baby’s condition, such as turning the mother, giving the mother oxygen, and giving extra fluids.
• The hospital overworked the nurse assigned to Mrs. Kipoliongo’s labor, giving her a second patient for whom she was also primarily responsible. Standards require one-on-one nursing during a labor that is as involved as hers was. The stimulating drug Pitocin requires close monitoring. In addition, Keren was under-sized (a condition called “intrauterine growth restriction”), and that is why they were proceeding with a scheduled birth rather than wait for labor to start on its own. (At autopsy, Keren was found to have completely normal body organs; her only issue was being small.) [I note that the overwork might have included having to interact with an EHR presenting a mission hostile user experience, as I've seen in critical care environments and have worked to specifically avoid when I was in charge as here - ed.]
  
• Inspection of the computerized hospital record showed that this nurse, Julie Bates Gilpin, made most of her entries in the record hours after the purported observation time, including a whole series of entries after her shift ended. [I have seen this phenomenon myself; some EHR's allow entries even without a time stamp, and the only way to ascertain when entries were made is via discovery of metadata (automatically generated audit trails and other data that shows who manipulated data, and when. Hospitals often resist providing full metadata, despite Federal Rules of Civil Procedure (FRCP) governing e-discovery enacted almost 6 years ago - ed.]
  
• We asked the nurse at a deposition why her entries showed such regular times of observation, at exactly 15 minutes after the hour, 30 minutes, 45 minutes, etc. She told us that was because she “rounded” on her patients every 15 minutes. But later we discovered – after winning a “motion to compel” in which the judge required the hospital to turn over records of the other patients Ms. Gilpin was monitoring that night (with names blacked out) – that she was also recording the same exact pattern of observations on her other patient, at 15 past the hour, 30, 45, and so on. So when we compared our client’s record with the other patient, it was clear that Nurse Gilpin was making computer entries showing that she was in two places at once. Again, most of these entries were made hours later and back-timed. [I also wonder, during the actual clinical encounter time was the nurse treating the actual patients or the e-Patient, i.e., the 'virtual patient' represented by the computer screens? - ed.]
  
• We also wanted to know why the alarm on the fetal monitor went off 12 times during the night but was answered only one of those times by Nurse Gilpin. We discovered that these monitors have alarm reset buttons like a snooze button on an alarm clock. You can hit the button and turn off the alarm without doing anything else for the patient. Most of the time, the “snooze button” was hit by a nurse at the nurse’s station. What did this mean? The monitor was supposed to be tracking two separate twin babies. [Not exactly what I would call a "state of the art" alert design - ed.] The alarm would go off when the signal was lost for one baby. The nurses are supposed to reposition the patient so they can pick up the signal again. They didn’t do that for most of the times that the signal was lost. So it turned out that hours went by during the night when nothing was tracked on baby Keren’s heartbeat.
• Even worse, we found out that when we took Nurse Gilpin’s testimony, she no longer remembered how to do her job on the labor and delivery unit even though she had worked there up until a few months before the time of her deposition. We asked her how a nurse reads the fetal monitor and what are bad signs for the baby, and she said she didn’t know.
• And even worse than that (the wrongdoing kept piling up in this case as we continued our investigation), the resident doctor, whose name was Dr. Sahardat Nurudeen, and who was the only physician monitoring our client’s labor progress for nearly eight hours, also claimed at her deposition that she couldn’t read a fetal monitor tracing even though she was in training to become an obstetrician. (In fact, she had completed her full obstetric residency and was preparing for her board certification test at the time of her deposition.) We say “claimed,” because it could be that she just wanted to avoid answering tough questions at the deposition about individual segments of Keren’s monitor strips. Either way, it wasn’t good for high quality, accountable patient care.

We finally concluded that there were many chances during that night to save Keren’s life, but the understaffing and overwork and apparently poor training (how could a nurse or a young doctor forget how to read a fetal monitor, a basic part of their training?) [and the toxic effects of ill-conceived and ill-implemented technology - ed.] led to an unnecessary tragedy.

This story should give pause to technophiles in medicine who ignore technology's possible downsides, and the clinicians who are compelled to center their clinical lives around such technology (while the purveyors of that technology are often held harmless by hospital executives in violation of the latter's fiduciary responsibilities).

-- SS

London Ambulance Service: Would You Like Some Death And Mayhem With Your American Healthcare IT?

It seems American companies are good at producing really noisome commercial healthcare IT and foisting it on other countries, such as outlined at "Is clinical IT mayhem good for [the IT] business? UK CfH leader Richard Granger speaks out" and at "Cerner's Blitzkrieg on London: Where's the RAF?".

Yet another example: Software for the London Ambulance Service (LAS). From Wikipedia:

The London Ambulance Service NHS Trust (LAS) is the largest "free at the point of contact" emergency ambulance service in the world. It responds to medical emergencies in Greater London, England, with its ambulances and other response vehicles and over 5,000 staff at its disposal.

Thanks to the U.S., the inhabitants of London are now the unconsenting subjects of an American IT beta-testing experiment that could cost them their lives.

From E-Health Insider.com:

LAS plans for IT go-live and failure
E-Health Insider.com

25 January 2012
Shanna Crispin

London Ambulance Service NHS Trust may terminate its contract with American supplier Northrop Grumman if a second attempt to go-live with a new dispatch system fails.

The trust initially attempted to launch the CommandPoint computer aided dispatch system in early June last year.

However, the technical switch-over to the new system had disastrous effects; with the system failing, staff having to use pen and paper, and then finally aborting the go-live by reverting to the old CTAK dispatch system.

Health IT can kill you ever before you ever reach the hospital...

An investigation into the incident has found the response to calls was delayed by more than three hours in some cases. One patient has lodged a legal claim for the delay he experienced, and the service has received four additional complaints.

A patient died in one of the calls affected. However, a separate investigation concluded that it could not be determined whether they would have survived if the response had been faster.

In other words, the patient very well might have survived without long delays for the ambulance to arrive.

Board papers drawn up for a board meeting next week say an investigation into the 8 June go-live attempt concluded that critical configuration issues were not identified during the testing phase.

It also found there were no operational procedures in place in the event of a critical system failure and that the product failed to deliver the system, technical and operational functionality expected.

At least in this case an absolution for the software itself was not made. One wonder if the vendor was "held harmless" contractually for this somber outcome.

The trust has since been working to further test the system, and is planning to go-live again on 28 March.

However, the trust’s director of information management and technology, Peter Suter, said if that go-live failed then “the contract with Northrop Grumman would need to be reconsidered.”

That will make two chances to get it right. In life-critical IT, I would only have given one.

A defective first-responder system is, on first principles, a public health menace. There is nothing to argue here, nothing to discuss on that point.

I note that disrupting the first-responder system in London would be the envy of terrorists, especially at the time of the London 2012 Olympic Games. However, who needs them when you have U.S. IT personnel who create a system as described?

The trust completed testing the software prior to Christmas, when it began training staff. Leading up the March go-live, the software will be subjected to four separate live runs, with the system staying live for progressively longer periods of time.

If the system fails to go live in March, the trust will abandon any further attempts to go-live before the Olympics in July.

That's still very tight timing to discover all the bugs in an IT system, in preparation for expected increased need during the Olympics...

Instead, it will keep operating the current CTAK system. However, the trust decided to procure a new system in 2007 because CTAK was deemed ‘unstable’ and in need of replacement.

An analysis of the CTAK system has now determined it is stable enough to handle the increased pressure during the Olympics, which is estimated to be an increase of 5.6% to 8.9% on top of the usual volume for this time of year.

One wonders if the "new system" was not needed at all, but was instead sold as vaporware by impressively attired, good-haired, shiny-toothed, fast-talking salespeople to hapless decision-makers with all sorts of promises of cybernetic and financial miracles.

(I've been in that game before from both sides - as a potential customer, and as part of a health IT sales team.)

One also wonders if, should the system be dismantled due to a second failure, the British taxpayers who paid for it will get their tax dollars refunded.

-- SS

North Bristol Hits Appointment Problems: Another "Our Lousy IT Systems Screwed Up, But Patient Safety Was Never Compromised" Story

At my Dec. 2011 post "IT Malpractice? Yet Another "Glitch" Affecting Thousands of Patients. Of Course, As Always, Patient Care Was "Not Compromised" referencing prior posts, I wrote:

... At my Nov. 2011 post "Lifespan (Rhode Island): Yet another health IT glitch affecting thousands - that, of course, caused no patient harm that they know of - yet" I wrote:

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches" here, here, here and at other posts which can be found by searching this blog on the banal term 'glitch'.

Another "our clinical IT crapped out , BUT ... patient care/safety was never compromised" story just arose:

North Bristol hits appointment problems
E-Health Insider
11 January 2012
Rebecca Todd

Clinicians working at North Bristol NHS Trust have expressed concern about disruption to patient care, which they say is caused by appointment problems following the go-live of a new Cerner Millennium electronic patient record system.

I would have entitled the article "North Bristol hit by IT-created appointment problems."

Reported problems include patients being booked into non-existent clinic appointments or not being told about scheduled operations, resulting in some operations being cancelled.

No patient care compromise possible there. Who, after all, needs a timely operation? It frees up a lot of money for IT golf tournaments to let those of no value to society (i.e., the old, and those who will not admit computers in healthcare with deterministically revolutionize medicine because, well, they're magic) simply die due to delayed or cancelled surgery...

Ehealth Insider understands that some of the problems relate to the way the trust configured the EPR system; including setting up dummy clinics for which appointment letters were subsequently sent out.

It's never the software or computer's fault.

As a matter of fact, I have not seen any official response to the work of Dr. Jon Patrick at U. Sydney on the many software engineering flaws of another product of the same company. His work is entitled "A study of an Enterprise Health information System" and is at this link: http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146. Do they have Class Action lawsuits in Australia?

In a regional BBC news report, aired on Monday evening, anonymous hospital clinicians called the implementation a “complete shambles” and said it represented a “potential danger” to patients.

According to the BBC report, the problems meant patients were being booked for impossible appointment times, such as 12.05 am, and quoted correspondence saying staff and the system were both on the “verge of meltdown."

The clinician comments are anonymous since non-anonymous reporting would get the clinicians declared health IT apostates, and then excommunicated. Non-anonymous 'whistleblowers' could also fear being sued due to possible gag clauses - the kind of clause hospital executives sign in violation of their fiduciary responsibilities to their staff and to patients. (See my 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards"at this link and the much-expanded essay on the same themes "Health Care Information Technology Vendors' Hold Harmless and Keep Defects Secret Clauses" at this link.)

Martin Bell, director of IM&T at the trust, confirmed to EHI that North Bristol had experienced some “unexpected problems” in the past few weeks with some of the outpatient appointments and theatre lists.

Bell stressed, however, that patient safety had not been compromised and that this continued to be the top priority.

There's that line again. Perhaps it's part of some hospital administrator JournoList-recommended catchphrase for describing how safety was not compromised during a major workflow disruption?

He said the problems were not down to the software itself, but due to “implementation and data migration difficulties in some clinics."

Right. Quite credible.

“Our information management and technology team, supported by our suppliers BT and Cerner, have been working very hard to sort out any initial issues as quickly as possible and we are already seeing improvements,” he said.

Congratulations are due. They are seeing "improvements" in dangerous clinical IT malfunctions that should never have to have been seen in the first place, if the statement is true.

“Many wards, our two minor injuries units and the Emergency Department, are successfully using the new system." The trust is one of the largest in the South of England, with more than 1,000 beds.

Just give them time.

EHI understands that as part of the Millennium implementation, dummy clinics were set up. Patients were then sent appointment letters for these clinics in error.

EHI also understands that some patients had also not turned up for scheduled operations because they had not been informed about the booking.

Bell apologised to patients who had been “inconvenienced during this transition period” and said staff had shown real dedication to continue to deliver patient care.

What if someone had been inconvenienced into their grave, or ends up there as a result of delays? On what wavelength will the apology be transmitted?

“We firmly believe that the new system, once fully implemented, will improve services for our patients and provide real value,” he said.

That seems to be the mantra, but delivery on such promises are rare. See "Pessimism, Computer Failure, and Information Systems Development in the Public Sector" as here, Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand. The article is a cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.

A £69m contract for BT to deliver Cerner Millennium to three new, or ‘greenfield’ sites in the South of England was agreed in April 2010, under the auspices of the National Programme for IT in the NHS.

That would not be the failed National Programme for IT in the NHS, the NPfIT what went PfffT, would it?

North Bristol was the last of these three sites to go-live with the system in December last year.

It followed Oxford University Hospitals NHS Trust, which went live a week earlier, and Royal United Hospital Bath NHS Trust, which was the first to go-live in July.

Cerner said it was working closely with North Bristol and BT on the recent implementation of Millennium.

“In complex and large deployments, especially when migrating from two different systems, it is always anticipated that it would take time for the new system to bed-in,” it said in a statement.

The patients are given full informed consent on this issue, right? Right?

“Across much of the trust, the deployment has worked well. However, this is a major change management project and there have been some difficulties with outpatient appointments.

“Although this is not a problem with the software, Cerner is working in partnership with BT and trust staff to resolve any issue as quickly as possible.”

Link: BBC News

Right. Perhaps this software and claim needs testing - in a court of law.

The only thing missing is the word "glitch", though I am including that term in this posting's index, since I consider it another story in the ever-growing health IT "glitch" series.

-- SS

Addendum:

A reader sent me this comment:

How can anyone claim the problems at N. Bristol are unexpected. they are EXACTLY the same problems encountered in Taunton five years ago.

The Somerset Trust had sixteen cancelled go live dates and when Cerner 'Millennium" (note: they never defined which Millennium...) was switched on the whole hospital went into slow-motion.

Appointments could not be made at out-patient reception desks while patients waited and therefore had to be posted on. Twenty-four whole time equivalent clerks had to be employed to manage the back-up of appointment requests. So much for enhanced efficiency and cost savings.

The only possible response to this news is again to remind people of Einstein's famous definition of insanity: "repeating the same thing again and again and expecting a different result."

As for other Trusts, why no news of transformed performance by Cerner's systems at other Cerner implemented sites, Berkshire, Newcastle, Kingston, Oxford etc. The only 'good' news we get is that the system has been switched on.

If any of this expensive activity had really produced data, efficiency or cost gains, we would be drowning in Cerner press releases, the silence can only mean one thing, that their system is performing as poorly at other sites as it has in the South West.

Contrast this with the output and data produced openly by Birmingham University Hospital from its in-house created IT system.

Unfortunately one can only draw one serious conclusion about the whole Cerner/ NHS debacle - to paraphrase Mr. Clinton - "It's the (imho substandard) software, stupid!

This story needs serious investigation ... Recently US news items have started to discount the supposed efficiency gains for e-Health implementations and started to emphasize data capture and patient safety as the imperative for switch on. Unfortunately for Cerner supporters (and other vendors) the US Institute of Medicine's recent report stated unequivocally that there was (to everyone's apparent surprise) no quality evidence that e-Health improved patient safety.

I would contend no drug, therapeutic equipment or operation would or could be implemented in secondary care in the absence of critical and peer reviewed evidence of benefit [emphasis mine - ed.] that has characterized the rush to switch-on substandard IT solutions in English NHS hospitals.

I note that critical, peer-reviewed evidence, especially based on prospective randomized clinical trials as opposed to anecdotal, weak retrospective observational studies, have been deemed unnecessary in health IT.

Yet serious case reports of risk and injury from credible sources are deemed the true "anecdotes" and discounted. As I've written before, the science of medicine is nearly entirely lacking in the domain of health IT.

To put it in the words of James Le Fanu (channeling Sherlock Holmes) in his very apropos essay entitled "The Case of the Missing Data: The Dog That Didn't Bark", details on contrary strands of evidence that could reasonably have been expected to appear in evidential text are absent.

-- SS

IT Malpractice? Yet Another "Glitch" Affecting Thousands of Patients. Of Course, As Always, Patient Care Was "Not Compromised."

At my Nov. 2011 post "Lifespan (Rhode Island): Yet another health IT glitch affecting thousands - that, of course, caused no patient harm that they know of - yet" I wrote:

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches" here, here, here and at other posts which can be found by searching this blog on the banal term 'glitch'.

Add another case to the health IT glitch file, under the "do we feel lucky today?" patient risk category.
From the Pittsburgh Post-Gazette (I am quoted):

Computer outage at UPMC called 'rare' Systemwide disruption potentially dangerous, expert warns Saturday, December 24, 2011 By Jonathan D. Silver, Pittsburgh Post-Gazette

UPMC's electronic medical records system for inpatients went offline for more than 14 hours at nearly all its hospitals in the region, marking what the health system called a "rare" outage, but one that it claims did not harm patients.

First, as my aforementioned Nov. 2011 post and its contained links point out, these events are not as "rare" as they should be. (The asteroid colliding with Earth that caused the extinction of the dinosaurs - now that's a "rare" event.)

Second, as multiple posts on this blog have pointed out, the claims that "no patients were harmed" is both misleading and irrelevant:

Such claims of 'massive EHR outage benevolence' are misleading, in that medical errors due to electronic outages might not appear for days or weeks after the outage, depending on what information was corrupted/lost/misindentified/or otherwise mishandled after it is 'backloaded' once the system is up. All it takes is one med lost to cause misery and death. (I can speak about that from unfortunate personal experience.)

Claims of 'massive EHR outage benevolence' are also irrelevant in that, even if there was no catastrophe directly coincident with the outage, their was greatly elevated risk. Sooner or later, such outages will maim and kill.

The outage affected a system designed by Cerner Corp., a global electronic records company, and customized by UPMC that doctors and nurses rely on for communication about patient records, medical orders and prescriptions.

It was unavailable from about 8:45 p.m. Thursday to 11 a.m. Friday at almost all of UPMC's hospitals except for Children's and UPMC Hamot in Erie, spokeswoman Wendy Zellner said.

"This is rare. This kind of widespread, extensive downtime would be rare," Ms. Zellner said.

Doctors and nurses continued to have access to patients' electronic records through backup systems, she said. They also had to resort to using old-fashioned paper records for documentation and orders.

"These things happen. They have really well spelled-out procedures for what to do when something goes down," Ms. Zellner said.

She acknowledged that doctors and nurses faced some challenges.

Faced 'some challenges?' In other words, care was compromised by the outage and the 'challenges' were to avoid medical error (and, of course, to make sure billing was unaffected):

Compromised -

a. To expose or make liable to danger, suspicion, or disrepute

b. To reduce in quality, value, or degree; weaken or lower.

Thousands of patients were affected, again reinforcing my point about how IT can and does greatly amplify the risks of paper -- as in my Rhode Island post -- such as errors and confidentiality breaches.

I cannot, for example, think of a single instance where thousands of paper records went unavailable simultaneously (unless, that is, someone lost the key to the Medical Records department), were made available to identity thieves en masse, or where thousands of medical orders were scrambled or truncated in a relatively short period of time as in Rhode Island.

These amplified risks could wipe out any advantages of EHR's over paper in a microsecond.

A partial list of facilities apparently affected in this latest episode of EHR mayhem, from this list:

• Magee-Womens Hospital of UPMC
• UPMC Bedford Memorial
• UPMC East
• UPMC Horizon
• UPMC McKeesport
• UPMC Mercy
• UPMC Montefiore
• UPMC Northwest
• UPMC Passavant
• UPMC Presbyterian
• UPMC Shadyside
• UPMC St. Margaret
• Western Psychiatric Institute and Clinic of UPMC

That accounts for several thousand active patients, I am sure.

(12/28 Addendum: Bed counts of PA hospitals are here. Searching on "University of Pittsburgh Medical Center", it can be seen that thousands of beds were indeed involved.)

"Whenever people aren't working in their native system and workflow I have to believe that is more cumbersome for the clinicians, but these folks are well-trained in what to do when these things happen."

This seems at best an insensitive and perhaps even inhumane bit of P.R. More "cumbersome" for the clinicians? What about the poor patients? How would Ms. Zellner feel, I wonder, if it were her mother, child or significant other on the Operating Room table or having an acute MI when the EHR/CPOE systems went down?

Ms. Zellner said UPMC's public relations staff was unaware of the outage until contacted by a reporter.

It appears P.R. is not very high on the list for receiving information when a crisis arises. I may have known of the outage before they did.

The outage was caused by a "bug" or glitch in software designed by a vendor affiliated with Cerner, Ms. Zellner said. She refused to identify the company.

"We're not trying to point fingers at different vendors. It's a database bug, that's all I can tell you."

(That is, it's not our fault, it's the fault of the database vendor. Hospitals, I regret to inform you - you are responsible for unapproved medical devices used in your facilities, no matter what the source.)

And there's that word "glitch" again, accompanied by the equally banal "bug."

It's just a "bug." Cute little critter!

Me again in the Post-Gazette:

Scot M. Silverstein, a doctor and assistant professor Healthcare Informatics at Drexel University in Philadelphia, disagreed with the use of the terms "bug" and "glitch."

"What occurred here was a disruptive, potentially dangerous major malfunction of a life-critical enterprise medical device," he said.

Somehow, when a clinician makes a mistake, the terms "bug" and "glitch" are never used. In fact, when clinicians fail to meet accepted professional standards of healthcare practice, it is called "malpractice."

I think we can all agree that a major near-full-day outage of an enterprise EHR affecting multiple hospitals and thousands of patients does not meet accepted professionals standard of life-critical computing practice. Yet, all this merits is the word "glitch." It seems to me that if patients are harmed by, in reality, what is (on its face) IT malpractice during such events, not only the clinicians affected should be held liable.

Ms. Zellner said the problem was not a "crash" of the system because there were alternate methods used to cope that prevented patient care from being compromised.

The usual refrain. Let me repeat my definition of "compromised:"

Compromised -

a. To expose or make liable to danger, suspicion, or disrepute

b. To reduce in quality, value, or degree; weaken or lower.

A simple question - if extended EHR outages like this never seem to "compromise" care, then why not eliminate health IT entirely and spend the hundreds of millions saved on patient care?

"This is not a crash of Cerner either," Ms. Zellner said. "I think a crash is, 'Oh my God, the sky is falling,' nobody can get anything."

I leave it to the readers to ascertain the computer expertise levels and reasonableness of what Ms. Zellner thinks a "crash" is.

Technicians from UPMC, Cerner and the third company [the 'mystery' database company? - ed.] worked together on-site to identify and fix the problem. Ms. Zellner said she did not know why it took 14 hours to fix and the underlying cause was still unclear.

"They know what the problem is and I believe it's been fixed, but we really don't know what triggered it," Ms. Zellner said. "I think the next step would be some actual software upgrades."

They "don't know what triggered the 'problem'" - is a proper translation that they have no idea what went wrong?

In fact, regarding another Cerner EHR system which was extensively studied (see "A Study of an Enterprise Information System" at this link), Dr. Jon Patrick came to the conclusion that one of the sources of catastrophic failures is poor software engineering that has made the behavior of the studied system "non-deterministic." Further, software upgrades are not protected from incremental changes made by maintenance and customization staff, and may introduce even more instability.

A software upgrade without clearly understanding "what triggered the problem" is simply asking for more trouble. (My bet, however, is that they attempt it anyway.)

A Cerner representative could not be reached for comment.

What's to say?

How about this:

Dr. Silverstein said based on what he was told about the computer outage, it means that hospital medical staff would have been unable to update patient charts and probably would not have been able to issue any orders through the system during the time it was off line.

He also questioned how up-to-date the hospital's redundant records were.

Repeating UMPC's statement from the article that appeared after I gave my quotes to the reporters: "Doctors and nurses continued to have access to patients' electronic records through backup systems, [the UPMC spokesperson] said. They also had to resort to using old-fashioned paper records for documentation and orders."

My stated fears of disruption and increased risk due to compromised care seem well-grounded.

In May, Allegheny General Hospital had to shut its electronic medical records computer system down because of problems with the vendor's hardware.

The hospital used backup procedures to continue care for patients, including using paper orders and record-keeping.

Wait ... I thought I'd heard these events were "rare." Two in the same city within six months?

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

Truth be told:

The primary rule in computing is:

Either you are in control of your information systems, or they are in control of you.

Clearly the latter was the case here.

The following questions arise:

• Was the software containing the "bug" properly vetted before being used on live patients? This is not just the vendor's obligation.
  
• If it was not vetted properly, why not?
• Was it an "upgrade" or patch? (If so, the same vetting rules apply.)

Further, the soft-selling of these incidents must end. The use of terms such as "bug" and "glitch" must also end. What occurred here, echoing my newspaper quote, was a disruptive, potentially catastrophic major malfunction of a life-critical enterprise medical device.

System-wide EHR crashes are not merely ‘glitches’ or ‘bugs.’ They need to be considered, as in medicine itself, as 'never events.' From AHRQ:

The term "Never Event" was first introduced in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum (NQF), in reference to particularly shocking medical errors (such as wrong-site surgery) that should never occur. Over time, the list has been expanded to signify adverse events that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable.

Further, re: "patient care was never compromised." How do they know that? In fact, this is 'spin' and word games on its face. By definition, if CPOE and chart updating was unavailable, patient care was compromised, where "compromised" means "increased levels of risk for error were created, requiring workarounds."

Further, as mentioned earlier, harms might not show up for some time. Lost orders, corrupted data, errors of omission or commission transcribing backup paper records into the computer ("backloading"), etc. can take their toll later. Post-outage vigilance is essential, putting even more stress on clinicians that increases likelihood of further error and that they certainly do not need. Clinicians are stressed enough already.

Finally:

IT personnel have not only deliberately inserted themselves into clinical affairs (e.g, via the HITECH Act of 2009), they have also done so with a stunning arrogance and unproven braggadocio about their systems "revolutionizing" medicine (whatever that means).

Indeed, they need to accept the medical responsibility and obligations this territorial intrusion entails.

On its face, this massive outage was the result of issues that did not meet accepted professional standards of IT practice for life-critical environments. Res ipsa loquitur.

Something was not vetted properly, there was a lack of redundancy, the IT personnel were NOT in control of their systems.

Just as when physicians don't provide care that meets accepted professional standards of healthcare, this incident and others like it are, by definition, a result of IT malpractice.

If patients are harmed, IT personnel and their management (often non-IT C-level officers) involved in this system need to be held accountable.

If they can't take the clinical heat (as clinicians do daily since the time they enter medical or nursing school), then they need to get out of the clinical kitchen.

-- SS

Note: see this take on these matters at the HIStalk blog:

UPMC’s Cerner systems go down for 14 hours at most campuses last Thursday and Friday, forcing them to go back to paper. The PR person blamed “a database bug,” which makes the above Oracle press release from this past summer a particularly fun read. Cerner and UPMC have an atypical vendor-customer relationship since they’ve invested big money together in innovation projects and UPMC runs a Cerner implementation business overseas.

Now we know who the unnamed "mystery database vendor" is...

-- SS

Dec. 29, 2011 Addendum:

Was UPMC acting as a "proving ground" for some Oracle-Cerner-UPMC experimental health IT technology that resulted in the crash? The claim of being an IT "proving ground" has been made in the past:

Pittsburgh Tribune
May 2, 2006
UPMC partners with technology provider

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

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

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

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

As I wrote at "Proving Ground for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?":

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

This is a fundamental human rights issue.

-- SS

Novel Idea on Healthcare IT: Worth a Billion Dollars!

From an AMIA announcement:

CMS Innovation Center Announces $1 Billion Funding Opportunity:

CMS announced a new initiative, the Health Care Innovation Challenge, which will provide grants for new ideas to improve care and lower costs for those in Medicare, Medicaid and CHIP. CMS will award up to $1 billion in grants for a 3 year period and is encouraging providers, payers, local government, public-private partnerships and multi-payer collaboratives to develop new and innovative ways to improve care. To learn more about the grants and application process, check out the CMS Innovation Center website and be sure to register for the CMS webinar on Thursday.

CMS, I have an idea!

It's a really, really novel idea!

"Let's regulate HIT to improve its safety, usability, usefulness, fitness for purpose, effectiveness, etc." ™

That will lower healthcare costs! Save lives, too!

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

Can I have my Billion Dollars now?

You can do a lot in health IT with a billion dollars - if you're not the HIT industry, that is, that has squandered a large wad of these over the past several decades.

-- SS

Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches" here, here, here and at other posts which can be found by searching this blog on the banal term 'glitch'.

(I note that when a clinician makes a mistake, it's never called a "glitch", it's called "malpractice.")

When health IT causes errors that can injure or kill, it's commonly referred to as just a "glitch", the banal, now-standard euphemism for computing malpractice.

Presenting the latest healthcare IT "glitch", affecting thousands:

Computer glitch led patients to receive wrong meds
Senator calls for review of Lifespan

WPRI.com (Providence, RI)
Updated: Thursday, 03 Nov 2011, 5:47 AM EDT
Published : Wednesday, 02 Nov 2011, 11:56 PM EDT
Reported by Steve Nielsen

PROVIDENCE, R.I. (WPRI) - Rhode Island State Senator Jamie Doyle says he is shocked to hear a Lifespan computer glitch caused thousands of patients to receive the wrong types of medication. [Appx. 2,000 across five Lifespan hospitals according to the Providence Journal, see below, and the WaPo - ed.]

Doyle is now calling for an independent review of all the hospitals Lifespan runs, and a review of the Rhode Island Department of Health.

The DOH is investigating after learning patients who were supposed to receive medications taken once a day instead received medications meant to be taken more than once per day.

"Oops."

[11/5/2011 note: As an anonymous commenter pointed out, the 2,000 or so errors at Lifespan should probably be multiplied by the number of organizations using the same software ---> "The entire country may have suffered 25,000-50,000 errors from this one glitch alone", the commenter astutely notes - ed.]

Of course, the customary "we did feel lucky today, and the gun was empty" disclaimer follows:

"Lifespan has not reported any adverse events or situations where patients required additional medications, but the information gathering and investigation is still ongoing," said DOH spokeswoman Annemarie Beardsworth.

In other words, there could have been adverse events, we just at the Dept. of Health don't know yet with certainty, because none have been reported yet.

In addition, some patients who were meant to get a medication with a coating did not receive a coating. The coating can help with stomach pains of other problems.

"I just don't feel comfortable right now with some of the things that are coming out of there," Doyle said, "I really don't want to point fingers in any direction. but what we need to do is we need answers." Senator Doyle wants to have the review started in the next two to three weeks.

Mr. Doyle, see my academic site on HIT failures here and an account of repercussions here from an EHR-related medication error.

Lifespan released the following statement Wednesday:

"Lifespan is actively contacting 2,000 patients affected by this issue to ensure they receive the correct form of their medications. So far, we have reached out to more than 90 percent of the patients, many of whom were already taking the correct medication."

Lifespan expects to finish contacting patients by Thursday.

It will be interesting to understand the nature of this particular "glitch" and who the software vendor is.

All it takes is a single "glitch" to seriously reduce a patient's lifespan.

Siemens software may be involved. See this mutually self promoting, marketing-style Siemens document "Newport Hospital - a Lifespan Partner - At the Forefront of EMR Adoption" (PDF), also cached here. (As an aside, one wonders if the hospital and/or its leadership received special financial or other "incentives" in allowing their name to be used in corporate promotions.)

Also, Siemens was a company that apparently did not listen to an internal informatics specialist physician's concerns that their health IT for critical care was endangering patients (link). They terminated the whistleblower.

Also see my Aug. 2009 post "Why Siemens Healthcare Fails" which I had emailed at the time to the Siemens Healthcare CEO Hermann Requardt.

-- SS

Nov. 4, 2011 addendum:

Felice Fryer of the Providence Journal sent me a link to the story of Nov. 3, 2011 she wrote with a few more details, here. Excerpts:

Flaw found in hospitals’ prescriptions

Some patients discharged from Lifespan hospitals got right drugs in wrong form due to software error

By FELICE J. FREYER JOURNAL MEDICAL WRITER

Some 2,000 patients of the Lifespan hospital group were discharged with incorrect prescriptions over the past 9 to 15 months because of a software glitch.

[It took a year or more to discover these mounting errors? This is beyond the "red flag" warning signs I used to write about. This is crossing the chasm into the territory of "asking for catastrophe" - ed.]
The prescriptions listed the right medications, but in the wrong form: people who were supposed to get time-release pills received prescriptions for short-acting ones.

The error affected dozens of generic medications for a variety of conditions. Lifespan discovered the problem on Oct. 25 and had fixed the software by Friday, according to Dr. Mary Reich Cooper, Lifespan’s senior vice president and chief quality officer.

The hospitals have placed calls to nearly all the affected patients, although not all have called back, Cooper said. Most patients reached had already obtained the correct medication because the error was noticed by someone at the hospital, or a pharmacist or doctor outside, she said. So far, Cooper said, there is no evidence that anyone was harmed.

But Dr. Michael D. Fine, state Health Department director, said that the incident is an example of how electronic medical records, which normally help reduce errors, can sometimes amplify them by quickly affecting large numbers of people. “It’s the flip side of what has otherwise been a process that has improved accuracy and reliability,” he said.

[I don't notice mention of a "flip side" to health IT in the aforementioned glossy hospital/IT company marketing brochure - ed.]
The Health Department is investigating the incident. Fine also plans to examine whether the department should regulate the safety of electronic systems in health care. [Readers of this blog know my opinion on that matter - ed.]

Asked whether he was worried there may be other as-yet-unrecognized software glitches, Fine said, “I’m reasonably concerned about the accuracy and integrity of electronic medical records.”... The software in question is not in use at other hospitals in Rhode Island, and the software vendor, Siemens, is notifying hospitals elsewhere in the country, according to Cooper.

[In the interests of public health, I believe it incumbent on Siemens to make this "glitch" widely known not just to the hospitals but to the public in areas served by those hospitals, especially with the admission that "the (RI) hospitals have placed calls to nearly all the affected patients, although not all have called back." To not do so reflects negligence in my opinion - ed.]
... The errors arose from the process known as “medication reconciliation,” in which the physician compares the medications a patient was taking before hospitalization with those prescribed during hospitalization, and ensures that the patient goes home with a correct set of prescriptions. The Lifespan hospitals recently adopted an electronic system for this process.

Doctors were correctly prescribing medication, and the prescriptions looked right on the computer screen, Cooper explained. But when printing out the prescription list, the software was cutting off a two-letter abbreviation that indicated certain medications should be in long-acting form or coated to protect the stomach.

[As at Case 9 from FDA's MAUDE database at the post "Our Policy Is To Always Have Unabashed Faith In The Computer". Do these vendors robustly validate their products? The current errors, in fact, were only peripherally related to medication reconciliation. They were primarily related to computer errors impairing (sabotaging?) the clinicians. It would seem med recon now needs to include comparing what the doctor enters to what is output to the nurses and other healthcare personnel who provide written instructions to patients. Is such a task performable by healthcare personnel when the computer cannot be trusted? Further, do the doctrine of the "learned intermediary" and "hold vendor harmless" clauses seem appropriate here? - ed.]
... Cooper said the risk of harm from taking a short-acting medication instead of a long-acting one was “very, very minimal.”

[Cooper misses the point, and IMHO such nihilistic attitudes have no place in healthcare - ed.]

But Fine, the health director, said such mistakes “can be scary.” People taking medication for angina or high blood pressure would find their medication wearing off over the course of the day, putting them at risk of heart attack or stroke, he said.

Medical errors that might seem innocuous or minor to health IT amateurs can prove catastrophic.  I've seen it happen, leading to injury and death.

-- SS