Yet another health IT "glitch", that warm, fuzzy euphemism for life-threatening malfunctions: Internet outage left doctors without records for hours

Up to 112,000, in fact.

Nobody seemed to be listening when I and other "Health IT iconoclasts" warned years ago of issues like this regarding the blind-faith abandonment of paper and lack of truly robust local computing redundancy. When you're a patient, especially one in extremis, you do NOT want this to happen:

Internet outage left doctors without records for hours
Huffington Post
8/19/2014

http://www.huffingtonpost.com/2014/08/19/internet-outage-doctors-records_n_5689260.html

For several hours last week, doctors at PIM Associates, a primary care practice in Philadelphia, couldn’t see patients' lab results or what medications they were taking.

Those digital records are stored in the cloud by a company called Practice Fusion, which makes software to help doctors track patients.

But Practice Fusion's service was disrupted over two days last week because its data center provider suffered an outage. That prevented many of the 112,000 health care providers who rely on the company's software from accessing patient records.

“If you’re in an office that's completely electronic and the system goes down, you're flying blind,” Kelly Gallagher, a medical assistant at PIM Associates, told HuffPost. “It could be potentially dangerous.”

Potentially?  I'd say dangerous, period.

The episode offered an example of the potential drawbacks of electronic health records. It also highlighted how technology glitches can have serious human consequences. In this case, some out-of-date Internet equipment created confusion for many doctors.

Injured or dead patients really don't care.   They just want their records available.  Paper seems not to suffer mass outages...

... the ability to view electronic health records online depends on the reliability of technology companies -- which can experience glitches and outages. Last August, an electronic health record system made by Epic Systems went dark for a day, preventing nurses and staff at clinics in Northern California from accessing patient information. Last March, an outage involving a digital health record system in Boulder, Colorado, made by Meditech prevented some people from scheduling surgeries, getting test results or making appointments, according to the Boulder Daily Camera.

I covered those stories on this blog, and many others accessible under the query link http://hcrenewal.blogspot.com/search/label/glitch.

Health care providers face similar risks as other industries that store data in the cloud, but the stakes for doctors are often higher. One New York doctor who uses Practice Fusion's software said the outage could have been "a disaster if you’re dealing with life and death situations."

 I think the stakes are the highest for the patients.

The doctor requested that his name not be used because he said he worried that Practice Fusion might further disrupt his service. “My whole practice is in their hands,” he added.

Physicians are now beholden to and supplicated to IT companies.   That is not a pleasant thought.

Practice Fusion said the outage affected about one-third of its users, but didn't compromise data security. The outage "was out of our and our data center partner’s control," a company spokesperson told HuffPost.

"We worked closely with our partner to minimize the outage’s impact to our broader user base,” the spokesperson said. “We are monitoring the situation closely with our data center partner to address any other issues that may arise.”

I urge anyone reading this, if they know of injuries that resulted, to contact me.  I will pass the information along to plaintiff trial lawyers.

Practice Fusion attributed the outage to what experts are calling a rare Internet "brownout." Internet traffic is carried by a series of routers and switches, but the Web is now becoming too big and complicated for some of the old equipment. Last week, for the first time, the number of pathways for carrying Internet traffic crossed the critical threshold of 512,000. Many old Internet routers and switches can’t remember that many pathways, creating disruptions or outages across some parts of the Internet where that equipment needs to be replaced.

Again, injured and dead patients don't care, some of whom were in extremis when these outages occurred.  In medicine, there is no room for miscalculation and excuses.  My message to IT companies is if you can't provide reliable service, for whatever reason, then get the hell out of the medical clinic.

... Jim Cowie, chief scientist at Dyn, a company that tracks network management, said such disruptions will only continue in the coming months as the Internet keeps growing and its aging equipment is not replaced.

“We’re going to see more of these small, localized outages wherever there are vulnerable pieces of equipment,” Cowie said.

Well, then, perhaps paper is needed.

... In a blog post, the company recommended that affected customers print out any patient records they need. 

They agree.

For doctors, some of whom have complained about converting to electronic records, the Internet outage last week gave them justification for still keeping old-fashioned paper records.

“Sobering not to have had access to my practice for the last two days. Thank god for paper charts,” Meenakshi Budhraja, a gastroenterologist in Little Rock, Arkansas, tweeted.

Health IT extremists who believe in the abolishment of paper need to heed case examples like this.

But they won't, and that's almost guaranteed, at least until a cybernetic Libby Zion case occurs.

-- SS

Yet another EHR "glitch" - insulin decreased per protocol, oops, I meant heparin

Yet another EHR "glitch" (http://hcrenewal.blogspot.com/search/label/glitch):

http://www.labornotes.org/2013/07/electronic-medical-records-friend-or-foe

An emergency room nurse described her frustrating experience trying to accurately document a dose of heparin, a blood thinner for patients with chest pain. “The doctor stated he wanted 4000 units bolus [all at once] and then a 1000 unit per hour infusion,” she wrote. “The order in Paragon stated 5000 units of heparin. I was given the option to decrease the dose, which I manually changed.

“However, I had to pick a reason why I decreased the dose. There was a drop-down box, and the only option was ‘Insulin decreased per protocol.’”

In the unregulated world of health IT, there's no pre-market evaluation or QC process to find little "glitches" like this that make it onto floors of live patients. 

The drug was heparin, not insulin. What was she supposed to do? “I contacted the pharmacy and spoke to three different people, and the final response was, ‘snapshot the screen and give it to your manager.’ This was a nine-minute conversation.”

That's really not very helpful to the patient needing heparin urgently.

The manager finally advised her to select the given option for insulin, then separately document that heparin, not insulin, was given.

No future mistakes are possible due to this little glitch "workaround", right?

That’s nine extra minutes away from the bedside, just to document one medication—and to document it inaccurately, to boot. Multiply that times the many different tasks and patients a nurse juggles every day, and you start to see the problem.

I point out that this order would have taken exactly ten seconds with a pen and paper.

I hear stories like this - odd "glitches" and "gotchas" - from medical colleagues at least weekly, and sometimes daily.

-- SS

Full Moon Friday the 13th: Computers down at Vermont's largest hospital

A health IT "glitch" hit in Vermont on Full Moon Friday the 13th (have some werewolf with your bad luck!)

Dark Shadows' Quentin Collins (David Selby) in a foul full-moon mood.

Note, however, that "bad luck" has little or nothing to do with mission-critical healthcare IT mass outages.  Mismanagement often does:

http://www.wcax.com/story/25773022/computers-down-at-vermonts-largest-hospital

Computers down at Vermont's largest hospital

Posted: Jun 13, 2014 4:12 PM EST Updated: Jun 13, 2014 4:12 PM EST

By WCAX News

BURLINGTON, Vt. -
A major, systemwide computer problem at Fletcher Allen Health Care in Burlington Friday.

The hospital says the computer system went down at 9:45 a.m. The glitch means doctors and nurses could not enter patient information into computers.

"Glitch" is an unfortunate euphemism for potentially harmful or deadly computer malfunctions, often due to mismanagement of that technology. See query link http://hcrenewal.blogspot.com/search/label/glitch.

Hospital spokesperson Mike Noble says information is now being recorded manually [i.e., on paper - ed.] Noble says the staff continues to provide the same care as normal and no surgeries were canceled because of the computer issue.

Noble says the issue appears to be an internal problem and not something from an outside computer provider.

It’s not known when the problem will be corrected.

This is yet another "the systems that revolutionize healthcare against all of paper's ills have all gone down, we don't know when they will be fixed, but patient care has not been compromised because we are resorting to paper" story (more at query link http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised). 

-- SS

In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red

At my Nov. 9, 2013 post "We’ve resolved 6,036 issues and have 3,517 open issues" (http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html) I wrote about "issues" (i.e., "glitches" including potentially injurious or deadly bugs and malfunctions) the organization was having with a new EHR at University of Arizona Health System.

Now we know part of the cost of resolving those 9,553 "issues."

http://azstarnet.com/news/science/health-med-fit/tucson-area-s-largest-area-network-racks-up-nearly-million/article_44d05d04-0acf-5fbc-8561-68d4bef3b577.html
Tucson area's largest health network racks up nearly $30 million in losses

June 01, 2014  •  By Emily Bregel, Stephanie Innes

Southern Arizona’s largest health network is $28.5 million in the red so far this fiscal year, and officials say a costly electronic medical records system is largely to blame.

The operating loss is unprecedented for the four-year-old University of Arizona Health Network, which includes two local hospitals.

Stellar management was clearly responsible for this wonderful outcome.  When will the layoffs start, I ask? That's the usual managerial solution for financial losses, and in this case I feel particularly worried about employees who did not obey the "suggestion" to only use "Words that Work" about this EHR (see http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html).

The electronic records system, from Wisconsin-based Epic Systems, has cost an estimated $115 million, including $32 million in unbudgeted costs for the first eight months of the fiscal year, which ends June 30, financial documents show. The extra costs are due primarily to a delay in getting the system live and funding additional training and support, officials said. It was supposed to be up and running by Sept. 1, but wasn’t operational until Nov. 1.

$32 million to fix 9,553 "issues", most likely due to implementation incompetence, plus some that perhaps the seller should have at least been partially responsible for...such as these:

• Pharmacy Medication Mapping Errors

• Microbiology Results Mapping Incorrectly 

• Prescription printing bugs

• Errors transmitting prescriptions

I note that real, live patients were the unwitting experimental subjects in this little software debugging project.

I also note that $115 million could have paid for an entire new hospital or wing - and these startup costs are just the beginning...

... There are other reasons for the network’s weak finances. UA Health Network officials say uninsured patients aren’t getting health insurance coverage through the federal Affordable Care Act as quickly as they’d anticipated, resulting in $11 million less than expected in patient revenue through February.

The network also lost federal dollars from a program that helped bridge the funding gap created by Medicaid rate cuts and a rise in uninsured patients. The Safety Net Care Pool, which also included Maricopa Integrated Health System and Phoenix Children’s, pumped $33 million into the UA hospitals for the first six months of the fiscal year. But that infusion ended Dec. 31 to coincide with greater health insurance availability through the Affordable Care Act.

It's not like these events were entirely unpredictable.  Perhaps priorities could have been rearranged, rather than dumping millions into a known money pit, the implementation of enterprise clinical information technology?

... “The issue is more about where we are going and what things are in place to change the trajectory,” Lynn said. “It was an especially difficult time financially because of Epic, there was no choice in the matter. That period of time has fortunately passed and now we can do much better.”

There certainly was "choice in the matter."  I also suggest to Mr. Lynn that the "trajectory" might end up being a ballistic one.

... A financial report presented to the network’s board of directors on April 24 says the Epic system’s higher-than-expected expenses this fiscal year were due to “implementation delays, additional training support and planned schedule reductions.” Some of the expenses were originally supposed to be in the prior fiscal year.

The report attributes $6.8 million of the current year’s losses to physicians spending enough time training to use the new system that they couldn’t see as many patients between November and January. Schedules were back to normal as of February.

One wonders just how much increased stress and pressure there is on clinicians with the new system in place.  

... Implementing the new system has hit the network’s finances hard, but over time it should improve patient safety by cutting down on unnecessary testing and medication errors, among other things, officials say. Eventually it is expected to save money because of its added efficiency.

"Should?"  Considering the issues I've outlined at this blog and my Drexel University Healthcare Informatics site (http://cci.drexel.edu/faculty/ssilverstein/cases/), this seems a type of wishful-thinking due diligence performed by those who believe in fairy tales and bargain sales of bridges like the one at latitude 40.7045096 N, longitude 73.99480549999998 W.

Let me make a realistic projection:  No money will be saved, e.g., see the opinions from Wharton at http://hcrenewal.blogspot.com/2009/06/wharton-on-healthcare-it-can-i-go-home.html.  

Another projection:  safety will be adversely affected, e.g., see the ECRI Deep Dive study at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html, the Top Ten Healthcare Technology Risks for 2014 at http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html and the FDA Internal Memo on H-IT Risks at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html, to name a few sources repeatedly mentioned here.

At the UA Medical Center’s south campus, the Epic system has taken doctors from paper charts and uncoordinated computer records to having all patient information — from angiogram and CT scan results to billing updates — in one place, accessible via iPhone.

Try doing medicine on an iPhone screen area...

“This is the future. We have to have electronic medical records,” said Dr. Kwan S. Lee, a cardiologist who is medical director of the UA Medical Center’s south campus.

"This is the future!!  We just have to do it!!"  Dr. Lee, I admire your exceptionally well-reasoned and thorough budget justification for putting your healthcare system $30 million in the red.  Congratulations!

... Lee cited a recent case where a patient who had been previously treated at Tucson Medical Center came to the UA Medical Center’s emergency room, having an acute heart attack. The standard of care in such cases is opening the artery within 90 minutes. In a rush against the clock, Lee was able to click on the patient’s record from TMC and see the area where the patient had prior surgery.

“The patient had consented to share information from Tucson Medical Center and it helped us immensely,” Lee said. “We would have possibly wasted a lot of time. The patient did very well.”

A far, far less expensive document image management system could have accomplished exactly the same goal.

One con is that the system is “a little overly complicated” because it tries to be all things to all people, he said.  “It was painful ... A lot of us are technophobes,” he said. “But there was no way we could move forward without adopting it.”

"A little overly complicated?"  Gee, I guess that's why physicians at Athens Regional Medical Center revolted as at http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html.  The system was just "a little overly complicated!"

"A lot of us are technophobes?"  How about "A lot of us are not EHR hyper-enthusiasts, but pragmatists?" (http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html).

Chief Information Officer Critchley agreed, saying that with the infrastructure in place, the system will be improved as needed over time.

“For better or worse, only when it’s live are you going to get the doctors and staff to engage and do the fine tuning of what it really means, and what they want to see happen,” Critchley said.

This is a political statement at best.  The assumption here is that this technology itself is some sort of miracle worker, just needing "fine tuning" to reveal its miracles.  In fact, most medical inefficiencies and dangers have nothing to do with documentation at all (e.g., see "Is healthcare IT a solution to the wrong problem?" at http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html).

The only miracle so far has been to put the system $30 million in the red, with more to follow.

... The UA Health Network, which began its Epic implementation in 2012, receives a little over $1 million per year in incentive payments, Critchley said.

That's nice.   They spent $115 million to qualify for a $1 million annual incentive?  Makes perfect sense to me ...

Adoption of electronic records is voluntary, but hospitals that don’t make the switch by October face Medicare payment cuts of about 1 percent, and increasing reductions each year.

At least one reporter reports this factoid accurately.  Hospital and industry execs are fond of misstatements that "EHRs are mandatory."

Critchley has worked on at least four other Epic installations around the country as part of his consulting work and says the UA Medical Center’s has been the least expensive, with the most aggressive timeline. He has worked on projects that cost more than a half billion dollars.

"Least expensive?"  "Half a billion dollars?"  It sounds like first class care for every underserved person in the United States could have been paid for instead of dumping the money into an unproven, experimental computer technology...

At Tucson Medical Center, a $31 million upgrade to its electronic medical records system — also the Epic system — began to reduce expenses [overall net expenses, or just on a limited per-account, cherry-picked basis?  I suspect the latter - ed.] almost immediately after it went live in 2010. TMC is among 3 percent of hospitals nationwide at the highest stage of electronic records adoption, based on an electronic records ranking system.

“We started to see efficiencies the first day,” said Frank Marini, TMC’s chief information officer. Transcription expenditures dropped by half, as doctors who had previously dictated patient notes instead documented them directly into the electronic record, he said.

And they had to type and/or manually edit the results of Dragon or some other VR software.  That's wonderful!  Save money by firing transcriptionists and making the physicians spend their valuable time and attention on clerical work.  Fine business!

TMC began its push to upgrade its partial electronic records system in 2009. The hospital’s early investments in infrastructure, starting in 2002, lowered the cost of adopting a comprehensive system, he said.

Thus, in fact, overall expense was probably several times the $115 million quoted.  Say, perhaps, half a billion dollars?

To any U. Az healthcare employee reading this - remember, if you are experiencing EHR difficulties, only use Words that Work!

-- SS

This EHR "glitch" killed three-year-old Samuel Starr - but patient safety was not compromised

Actually, safety was compromised.

I have written repeatedly that the term "glitch", an often-seen euphemism (usually accompanied with the phrase "but patient care/patient safety was not compromised"), is really a term for life-threatening health IT bugs and malfunctions.  See query link http://hcrenewal.blogspot.com/search/label/glitch for examples of health IT "glitches" (retrieves multiple posts).

Here's a "glitch" that tragically killed this boy:

Three-year-old boy dies after new NHS computer system delays heart treatment

Mar 05, 2014
By James Tute

http://www.mirror.co.uk/news/uk-news/samuel-starr-death-nhs-computer-3209365

Coroner Maria Voisin rules that new booking system meant he did not receive life-saving treatment

A three-year-old boy died in his parents' arms after a new NHS computer system failed to schedule him for a vital heart scan, a coroner has ruled.

Samuel Starr was born with a congenital cardiac defect and needed surgery not long after he was born in 2010.

Although he made a good recovery doctors said he would need regular tests to check on his progress.

But he did not have a scan until 20 months after his first major operation because of a delay following the introduction of a new computer system, Cerner Millennium.

When he finally had the appointment doctors found Samuel needed open heart surgery. During the procedure, Samuel had a stroke.

A month later, after further complications, he died in the arms of his devastated parents, Catherine Holley and Paul Starr, at Bristol Royal Hospital for Children.

There are some in my field who would (and have) called incidents like this "anecdotes" or "bumps in the road."

Yet, as I've recently posted, an internationally-renowned healthcare safety tester, ECRI Institute (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html), and the medical malpractice insurer of the Harvard medical community, CRICO (http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html), have confirmed cases like this are no mere anecdotes.  I estimate from their numbers, and from cases known to me personally and from descriptions of others, that on the order of ten thousand (that's likely low) patients annually are being injured and/or die as a result of bad health IT in the U.S. alone.  Lack of transparency about such incidents impairs knowing the true numbers.

Ms Holley wept as she told the hearing of the moment she kissed her son goodbye, saying: "He was a kind and gentle boy with a great understanding of the world.

"As we read Samuel his favourite stories, he died in our arms."

Avon Coroner Maria Voisin, recording a narrative conclusion, ruled the booking system meant Samuel was not seen and did not receive treatment.

This case somewhat reminds me of the case of a newborn whose x-ray test was done, but never looked at due to a bug in the software that scheduled films to be read, see http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html, case #2

Concluding a three-day inquest at Flax Bourton Coroner's Court in North Somerset, Ms Voisin said: "Samuel Starr was born with a complex cardiac disease. "He required surgery and regular check-ups at outpatients to manage his conditions.  "Due to the failure of the hospital outpatients booking system there was a five month delay in Samuel being seen and receiving treatment. "Samuel's heart was disadvantaged and he died following urgent surgery."

Just a "glitch."

Doctors diagnosed that Samuel had a restricted pulmonary artery - causing blood to easily flow away from his heart to his lungs - during a 20-week scan in pregnancy ... On March 3, 2010, Samuel underwent open heart surgery at Bristol Royal Hospital for Children. He was discharged six days later and referred to the Paediatric Cardiac Clinic at the Royal United Hospital (RUH) in Bath for check-ups.

In October 2010, Samuel had his first check-up, in which an echocardiogram, also known as an "echo", was carried out. Ms Holley said she was told the procedure would be next carried out early in the new year.

But it did not happen until April 2011 and an echo was not performed.  Paediatric cardiologist Dr Andrew Tometzki told the inquest he did not "deem it necessary" on that day to carry out the echo scan. Dr Tometzki then ordered a further review - where an echo scan would be carried out - in nine months' time.

Samuel's parents did not receive information about the check-up and raised their concerns with community children's nurse Clare Mees.

Ms Mees, who works for Sirona Lifetime Services, said she would chase up the matter with Dr Tometzki's secretary.

Medical secretary Annabelle Attridge insisted she had taken details and forwarded them on to a dedicated appointments team.

However, the inquest heard "glitch problems" with a new booking system meant the appointment was not logged. 

Apparently not due to human fault:

Paediatric clinic co-ordinator Donna McMahon said while Samuel's medical records had been created on the new Millennium computer programme, no appointments had been transferred across.

Just a "glitch."  Just a "bump in the road."

Ms McMahon said she was first aware of the appointment delay when she received an email from nurse Ms Mees in May 2012.

Samuel did not have the vital check-up until June 21.

Coroner Ms Voisin added: "This overall failure led to a five month delay in Samuel being seen by his cardiologist.

"This meant Samuel had not been seen for five months and had not had an echo for 20 months."

His parents were horrified when Dr Tometzki informed them Samuel required heart surgery that spring.

Just a "glitch."  Just a "bump in the road."

... "Just hours before his operation Samuel was dancing around the ward and telling the nurses all about Spiderman - we had to remind him to quieten down," Ms Holley said.

Samuel's chest was closed on August 8. As he was brought out of sedation on August 9, he suffered a stroke and cardiac arrests.

"It is clear that if the surgery had been performed earlier, the procedure would have been the same," Ms Voisin said.

But she said expert evidence found that as time went on "the more complicated the surgery is, as the more disadvantaged the heart is and the more difficult it is to get over the operation".

Delays in care of fragile patients - in this case a young child, but in many other cases, ED and ICU patients of all ages - is very unwise.

Samuel's condition continued to deteriorate and on September 6 his parents were recommended for treatment to be withdrawn after he had a second cardiac arrest.

The coroner said she would not write a report making recommendations to the hospital, as changes had already been implemented.

Likely, workarounds to bad health IT, inviting future catastrophe.

In my view, many cases such as this never make headlines, as the findings ignore the role of the IT and blame people, cases are settled with gag clauses, patients (who survive) or family are never told of the role of the IT, or lawsuits prove too expensive or too unpleasant to pursue.

But patient safety is never compromised by "glitches", and regulation will just stifle innovation.

My condolences to the parents.  I've suffered a death in my own family as a result of health IT, and I'm a specialist in the field.  Laypeople have no chance.

One should pray the next child affected in this way is not one's own.

-- SS

Mar. 25, 2014 addendum:  

Also see these related posts, the first mentioning "teething problems", another euphemism for potentially-deadly EHR malfunctions:

Cerner's Blitzkrieg on London: Where's the RAF?
 http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html 

North Bristol Hits Appointment Problems: Another "Our Lousy IT Systems Screwed Up, But Patient Safety Was Never Compromised" Story
http://hcrenewal.blogspot.com/2012/01/another-our-crappy-computers-screwed-up.html

-- SS

"We’ve resolved 6,036 issues and have 3,517 open issues": Extolling EPIC EHR Virtues at University of Arizona Health System

The public may believe that, in healthcare, only the Obamacare insurance exchange website has lots of bugs.  On those, see my Oct. 10. 2013 post "Drudge Report, Oct. 10, 2013, 9 AM EST: All that needs to be said about government, computing and healthcare" at http://hcrenewal.blogspot.com/2013/10/drudge-report-oct-10-2013-9-am-est-all.html.

Another pillar of the Affordable Care Act, electronic medical records (promoted with incentives for adopters and with penalties for non-adopters via the HITECH section of the 2009 economic recovery act or ARRA) are pretty damn bad themselves.  Only, those systems don't make it hard to find insurance.  Through bugs and other features of bad health IT, they directly interfere with safety and provision of quality care:

Bad Health IT ("BHIT") is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

At my Oct. 20, 2010 post "Medical center has more than 6000 'issues' with Cerner CPOE system in four months - has patient harm resulted?" (http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html) I observed:

From the October 2010 "News for Physicians affiliated with Munson Medical Center" newsletter, a large medical center in Northern Michigan, about more than six thousand "issues" with their Cerner CPOE.

... One wonders how many of those 6,000, and how many of the 600 remaining "issues" fall into categories of "likely to cause patient harm in short term if uncorrected" or "may cause in patient harm in medium or long term."

I note that Cerner CPOE is not a new product, nor are similar products from other vendors also afflicted with long lists of "issues." That there could be more than 6,000 "issues" at a new site suggests deep rooted, severe problems with CPOE specifically and health IT design and implementation processes in general.

Here's another such multi-"issue"-laden EHR, this at University of Arizona Health Network.  Image of frequent periodic "EHR Update" below.

"We’ve resolved 6,036 issues and have 3,517 open issues."

[Ignore the 'kewl dark sunglasses' worn by the hipsters at the top of this announcement.  Not sure if this has something to do with EPIC, but I consider the wearing of dark sunglasses by clinicians or any other staff in a hospital setting - where people are sick and/or dying - to be in exceptionally bad taste.]

The text starts:

ISSUES UPDATE as of 4:00 p.m., Nov. 8
We’ve resolved 6,036 issues and have 3,517 open issues.

That's a total of nearly ten thousand "issues."  As of now, that is.  "Issue" is a euphemism for "glitch" a.k.a. "software defect" and/or "implementation error", see http://hcrenewal.blogspot.com/search/label/glitch.

These "issues" are  in a supposedly "mature" product for which this organization has spent enormous sums of money, that has undergone "innovation" for several decades now - in an environment free from regulation, I might add.

Many of the "issues" reduce patient safety, and could or already may have resulted in patient harm.  Such items on this listing, seen below, which is updated frequently, include:

• Pharmacy Medication Mapping Errors – Making good progress: watch for further notices.  [Perhaps these should have been tested and fixed before go-live? - ed.]

• Microbiology Results Mapping Incorrectly [does that mean "mapping" to the wrong patient? - ed.]  – all known errors fixed, monitoring and working on enhancements. [As above, perhaps these should have been tested and fixed before go-live? - ed.]

• Prescription printing - output for prescription printing has been fixed

• Refill requests for providers will be routed to the CLIN SUPPORT In Basket pool for the provider’s department.  This was a decision made by UAHN leadership. [Not sure why this is being done; perhaps for approval by managers? - ed.] 

• Errors transmitting prescriptions will also be sent to the CLIN SUPPORT In Basket.  [Errors transmitting prescriptions? That's not reassuring regarding data integrity.  See ECRI report below  - ed.]

This is not to mention that all of the "reminders" that follow are a distraction to clinical personnel, who cannot be expected to remember all of them.

Bad as this is, at my April 1, 2012 post "University of Arizona Medical Center, $10 million in the red in operations, to spend $100M on new EHR system" (http://hcrenewal.blogspot.com/2012/04/university-of-arizona-medical-center-10.html) I observed that:

... $100 million+ is probably enough to pay for AN ENTIRE NEW HOSPITAL or hospital wing ... or a lot of human medical records professionals.

To add more bitter icing to this cake, I wrote about a campaign for clinicians to speak only in wonderful terms about the new U. Arizona Health System EHR at my Oct. 3, 2013 post "Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As 'Advised' At The University Of Arizona Health Network."  I observed the following about the "words that work" is the shameless 'suggested' script:

• Efficient - see aforementioned links as well as "Common Examples of Healthcare IT Difficulties" at http://cci.drexel.edu/faculty/ssilverstein/cases/

• Convenient - as above.  According to whom?  Compared to what?  Pen and paper?

• Improves patient safety and quality - see IOM report post at http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html .  We as a nation are only now studying safety of this technology, and the results are not looking entirely convincing, e.g. ECRI Deep Dive Study of health IT safety at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.  171 health IT mishaps in 36 hospitals, voluntarily reported over 9 weeks, with 8 reported injuries and 3 reported possible deaths is not what I would call something that "improves patient safety and quality" without qualifications.

• The Cadillac of its kind - according to whom?

• Patients at hospitals using this system love it -  Do most patients even know what it, or any EHR, looks like?  Have they provided informed consent to its use?

• Exciting - clinician surveys such as by physicians at http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html and by nurses at http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html shed doubt on that assertion.

• The best thing for our patients - again, according to whom?

• Sophisticated new system - "New"?  Not so much, just new for U. Arizona Health.  "Sophisticated", as if that's a virtue?  Too much "sophistication" is in part what causes clinician stress and burnout, raising risk

Considering the near 10,000 issues, the new ECRI Institute report "Top Ten Technology Hazards in Healthcare", 2014 edition comes to mind (https://www.ecri.org/Press/Pages/2014_Top_Ten_Hazards.aspx).  Named in that report, as has been the case for the past several years, is healthcare IT. 

This year's problem description is:

#4. Data Integrity Failures in EHRs and other Health IT Systems

"Data integrity failures" include "issues" (per the bad health IT description) such as: data loss, data corruption, data attributed to the wrong patient, etc.

ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research to healthcare to discover which medical procedures, devices, drugs, and processes are best to enable improved patient care. As pioneers in this science for 45 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. Strict conflict-of-interest guidelines ensure objectivity. ECRI Institute is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO is listed as a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services. For more information, visit www.ecri.org.

ECRI also produced the 2012 Deep Dive Study of Health IT Risk (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html), where in a volunteer study at 36 member PSO hospitals, 171 health IT "mishaps" were reported in just 9 weeks, 8 of which caused patient injury and 3 of which may have contribute to patient death.

In summary, The University of Arizona Health System, with components in the red, is spending hundreds of millions of dollars on an EHR system, that has had decades to mature. Yet, they are finding 10,000 "issues" already, a number of which reduce patient safety and are unresolved, with many more likely to be found.

They are also 'advising' their staff to speak in glowing, unsubstantiated terms to patients about an EHR system that has 10,000 issues, and not seeking patient consent to its use in mediating and regulating their care - or giving elective patients the information that might allow them to choose another less "buggy" hospital.

If (when) patient harm results from such cavalier hospital (mis)management, the juries are going to just love the dark sunglasses, I bet.

-- SS

A new and very interesting EMR "glitch" - no warnings on stopping a medicine that diminishes the effects of a second medication

A new and very interesting EMR "glitch" from a report I received recently:

... I found a glitch with my [name redacted] EMR. It probably happens with all EMRs. I had a patient on primidone (http://en.wikipedia.org/wiki/Primidone) for essential tremor. Later, his primary care put her on warfarin [a "blood thinner" - ed.] for atrial fibrillation. Some time after that, I took her off of primidone.  Her INR jumped to 7 or 8. [High - ed.] What happens is that the EMRs warn a physician pretty well if you START a medicine that interacts with warfarin, but fails to warn if you STOP a medicine that interacts with warfarin. If you are used to relying on your EMR to warn you about drug interactions, you can fall into this trap easily, as I found out. Luckily, the patient was not harmed.

In other words, if a medication that interacts with another medication by suppressing the latter's effects to some degree is discontinued, EMRs may not warn of it.  Stopping the former can accentuate the effects of the latter, and disaster can result.  A primidone metabolite, phenobarbital, decreases INR and the anticoagulant effects of warfarin (http://www.medscape.com/viewarticle/745645_3).  Stop primidone, but continue warfarin, and ... wham.

The alert algorithms were apparently not designed with this eventuality in mind ... probably because the designers never thought of this issue.  Medicine is not as easy as it might appear to the outside, non-expert observer.

-- SS

Setback for Sutter after $1B EHR crashes (in followup to post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals")

At my July 12, 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" (http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html) I reproduced a California Nurses Association warning about rollout of an EHR at Sutter:

RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals

Introduction of a new electronic medical records system at Sutter corporation East Bay hospitals has produced multiple problems with safe care delivery that has put patients at risk, charged the California Nurses Association today.

Problems with technology are not unique to health care ...  [What is unique to healthcare IT is the complete lack of regulation - ed.]

In over 100 reports submitted by RNs at Alta Bates Summit Medical Center facilities in Berkeley and Oakland, nurses cited a variety of serious problems with the new system, known as Epic. The reports are in union forms RNs submit to management documenting assignments they believe to be unsafe.

Patient care concerns included computerized delays in timely administration of medications and contact with physicians, ability to properly monitor patients, and other delays in treatment.  Many noted that the excessive amount of time required to interact with the computer system, inputting and accessing data, sharply cuts down on time they can spend with patients with frequent complaints from patients about not seeing their RN.  [Note: patients are not given the opportunity for informed consent about the risks, nor opt-out of EHR use in their care - ed.]

In related posts I'd observed such concerns being ignored by hospital management.  See header of the aforementioned post.

Now we have this:  a major system crash.

Healthcare IT News
Setback for Sutter after $1B EHR crashes

'No access to medication orders, patient allergies and other information puts patients at serious risk'

SACRAMENTO, CA | August 28, 2013

The nearly $1 billion electronic health record system at Sutter Health in Northern California crashed early this week, leaving nurses and clinical staff unable to access any patient information for a full day.
he Epic EHR was down Aug. 23 due to a planned upgrade for eight hours during which nurses and other clinical users could read medication orders and patient histories but had to record new data on paper to then be re-entered into the system later, according to reports from the California Nurses Association, part of National Nurses United, the largest nurses union in the U.S.

Then, on the morning of Aug. 26 at approximately 8 a.m., the system crashed completely, at which time nurses, physicians and hospital staff had no access to patient information, including what medications patients were taking or required to take and all vital patient history data. 
 
The Epic EHR went dark at several Sutter Health locations, including Alta Bates Summit Medical Center, Eden Medical Center, Mills-Peninsula Hospital, Sutter Delta, Sutter Tracy, Sutter Modesto and numerous affiliated clinics.

"This incident is especially worrisome," said Bonnie Castilla, RN, CNA legislative director, in a news release. "No access to medication orders, patient allergies and other information puts patients at serious risk.  These systems should never be relied upon for protecting patients or assuring the delivery of the safest care."  [This is no exaggeration.  My mother was nearly killed by such a problem when caused by an EHR defect (link) that I averted at the last minute by happenstance of showing up at the right time, while she recuperating from another EHR-related disaster - ed.]   

Some RNs also reported that Sutter failed to provide adequate support during the blackout and didn't implement adequate backup planning.
 
"All information such as medication administration records and patient histories was outdated by two to three days," said Mike Hill, Alta Bates Summit RN, in a news release. "There were no orders that could be seen of any kind through the day so nurses called for what they needed."

Kevin Sweat, an emergency room RN at Eden Medical Center, a Sutter affiliate, also weighed in on the blackout, saying that in his 12 years as an RN he has never seen a system crash like this. 
  

Worse, clinicians must now serve their Cybernetic Master to perfection, or be whipped (apparently to improve morale):

... "We have been on Epic for 5 months now, and we can no longer have incorrect orders, missing information or incorrect or missing charges. Starting on September 1st, errors made in any of the above will result in progressive discipline," according to another hospital memo sent to staff.

In the setting of dire warnings by the nurses of EHR dangers several months back that were likely largely ignored, if any patient was harmed or killed as a result of this latest fiasco, the corporate leadership has literally begged to be sued for negligence, in my view.

However I'm sure a press release soon will claim that "patient care has not been compromised."

Of course this includes now and moving forward, even with informational gaps all over the place.

-- SS

Aug. 29, 2013 additional thought:

The punishment for not being a 'perfect' user of this EHR is the ultimate "blame the user" (blame the victim?) game, considering the pressures of patient care in hospitals in lean times - partly due to EHR expense! - and EHRs that have not been formally studied for usability and are poorly designed causing "use error" (that is, a poor user experience promotes even careful users to make errors).  Cf. definition of bad health IT:

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

The study of usability is getting underway only now via NIST but will likely be done in an industry-friendly way due to health IT politics.

-- SS

Aug. 29, 2013 addendum

There have been numerous comments over at HisTalk (at http://histalk2.com/2013/08/27/news-82813/) defending the outage as not EPIC's fault.   From the point of view of clinicians - and more importantly, patients - it doesn't matter what component of the hospital's entire "EHR" (an anachronistic term used for what is now a complex enterprise clinical resource and clinician command-and-control system) went down. 

Aside from all the EPIC issues the nurses have been complaining about (see earlier July 12, 2013 post linked above), the larger problem is that IT malpractice occurred.  The term "malpractice" is used in medical mishaps; I see no reason why it does not apply to major outages of mission critical healthcare information technology systems.

IT malpractice in healthcare kills.

These are the types of nurses I'd want caring for me and mine.  Letting this kind of snafu go "anechoic" does not promote proper management remedial education on Safety 101 and on health IT risk, two areas of education that management appears to desperately need in hospitals.

-- SS

A Good Way to Cybernetically Harm or Kill Emergency Department Patients ... Via An ED EHR "Glitch" That Mangles Prescriptions

Yet another healthcare IT "glitch" - that banal little word used for potentially life-threatening software defects.  (See the query link http://hcrenewal.blogspot.com/search/label/glitch for more examples.)

An EHR/command and control system (including ordering, results reporting, etc.)  for hospital Emergency Departments, Picis Pulsecheck, was recalled by FDA.

Reason?  "Notes associated with prescriptions are not printed to the prescription or to the patient chart."  The data apparently is not being sent to the printer or being stored for future visits.  Instead, data input by clinical personnel, in one of the most risk-prone medical settings, the Emergency Department, is simply going away.

This is reminiscent of the truncation of prescription drug "long acting" suffixes, apparently by a Siemens system, that led to thousands of prescription errors (perhaps tens of thousands) over more than a year's time.  I wrote about that matter, as reported by the news media, at "Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet" at http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html. 

Regarding the current Picis recall, notes connected with prescriptions can be crucial to the pharmacist or the patient.  Loss of those notes - apparently due to a computer glitch and most likely in this case without the prescribing clinician knowing about it - likely have been going on for some time now, since two software versions (5.2 and 5.3) are affected.

The solution for now?

"Consignees were provided with recommended actions until they receive the necessary update."

In other words, a workaround adding more work to clinicians who now not only have to take care of patients, but in the unregulated health IT market need to (as if they don't already have enough work to do in the ED where chaos often occurs) babysit computer glitches as well - and pray they catch potential computer errors 100% of the time.

Below is the FDA MAUDE recall notice at "Medical & Radiation Emitting Device Recalls", from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119832.

At this additional link we find that this FDA recall was "Voluntary: Firm Initiated."  They apparently informed the FDA of the "glitch."

My question is - how did the company become aware of this "glitch"?  Also, were any patients put in harm's way, or injured, as a result of the prescription data loss?

FDA Device Recall Notice.  Click to enlarge; text below.

Class 2 Recall ED PulseCheck

Date Posted	July 29, 2013
Recall Number	Z-1814-2013
Product	Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.
Code Information	Software Versions 5.2 and 5.3
Recalling Firm/ Manufacturer	Picis Inc. 100 Quannapowitt Parkway Suite 405 Wakefield, Massachusetts 01880
For Additional Information Contact	Support Representative 781-557-3000
Reason for Recall	Notes associated with prescription are not printed to the prescription or to the patient chart.
Action	Initial customer notifications were sent via email on June 21, 2013 informing consignees of the recall and providing further instruction regarding the software solution. Consignees were provided with recommended actions until they receive the necessary update.
Quantity in Commerce	35
Distribution	Nationwide Distribution, including the states of: AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV.

Finally, I ask - how did this "glitch" escape the notice of the company before the software was put into production not in just one, but through two sequential versions?

I propose that the lack of health IT regulatory controls due to special accommodation makes thorough software testing less "desirable" by a company (largely due to costs).

Compare that to, say, software regulation in the Federal Aviation Administration:

FAA Aircraft Software Approval Guidelines - available at http://www.faa.gov/documentLibrary/media/Order/8110.49%20Chg%201.pdf.  Click to access.

The FAA document begins:

"This order establishes procedures for evaluating and approving aircraft software and changes to appropriate approved aircraft software procedures."

Software regulation in other mission critical industries like aviation and pharma make the health IT industry and its lack of regulation look pathetic.


-- SS

Today's Bad Health IT Systems: More Dangerous Than Paper?

I believe in 2013 that they are.

(Definition of bad health IT is here:  http://www.ischool.drexel.edu/faculty/ssilverstein/cases/)

I recently posted about two "glitches" in a major EHR seller's clinical systems, Siemens Healthcare, affecting safety-critical functions of medication reconciliation and medication ordering.

• Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?

• Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2

Considering these, plus the many "glitches" reported by the only EHR seller who does so via FDA's MAUDE database (see here: http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and the others posted at this blog at query link: http://hcrenewal.blogspot.com/search/label/glitch, the following issue needs serious consideration by policymakers.

Namely, the issue that enterprise electronic medical command-and-control systems, which today's "EHRs" in reality are, are on their face more risk-prone than the paper systems they are replacing.

The "glitches" reported above are clearly the tip of the iceberg due to industry norms of secrecy, the absence of most of the industry in reporting to FDA MAUDE or anywhere, and my limited sources of information.  It is likely the true level of "glitches" in live EHR/clinical IT installations is far, far higher  - conservatively, I believe, at least two orders of magnitude.

Workarounds to IT "glitches" such as recommended in the Siemens bulletins at the aforementioned posts cause hospital officials to have to  reliably get the notices to all users of the systems, including medical students, nurses, physicians and allied health professionals.

The workarounds also cause users to:

1)  have to deviate from habits of use acquired in training and active use of the systems in question;
2) remember, without fail, to deviate from habits of use acquired in training and active use of the systems in question, in effect giving them the responsibility of caring for sick patients and for "sick" information technology;
3) keep in mind any other extant workarounds that exist waiting for "fixes"; and
4) be constantly on guard for information storage failures.

In fact, the recent Siemens "glitches" and workarounds represent a clear danger to patient safety.  If these were more conventional medical devices, they'd be recalled.

See my Dec. 14, 2011 post "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death" (http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html) and July 23, 2012 post "Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems"(http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html) for examples where health IT defects similar to the Siemens issues were, in fact, recalled.

Further, with paper records or tangible images, a page or image can be lost, or it can be illegible.  In the case of lost, in any quality paper record keeping system the information stewards or others using the paper (e.g., office staff or ward clerks) will generally note the absence and act accordingly.  Further, illegible notes or orders will most often be recognized as illegible and result in attempted clarification or other corrective actions.

On the other hand, when electronic systems:

1)  lose modified information en masse as in the Siemens examples but keep the old, or
2)  when outright errors such as en masse truncation occur (as in the thousands of prescriptions whose long-acting suffixes were cut off at Lifespan in Rhode Island, see "Yet another health IT "glitch" affecting thousands" here: http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or
3)  images are lost (see "Potential Image Loss in GE Centricity PACS" here:  http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html) without warning-

- There are no "flags" that the obsolete, truncated or missing information is erroneous.

What remains is perfectly legible, perfectly convincing and perfectly deceiving.

Electronic healthcare information systems on their face create more risk than paper record systems.  Further, the problem with "bugs" and "glitches" will not go away with today's industry models of "hiring down" and lack of regulation.  Every new upgrade or patch is suspect for introducing new bugs.

Paper does not suffer these issues, unless disappearing ink is used to cross out the old and add new information ...

Not that I am advocating for a return to 100% paper, but certain critical functions probably are best left to paper.  Further, hundreds of billions of dollars can certainly buy:

1)  a lot of Health Information Management professionals to perform continuous QA of paper,
2)  a lot of document imaging systems to make the paper records available anywhere, anytime they are needed, and
3)  a lot of data entry personnel to relieve clinicians of clerical burdens so they may use their valuable experience more productively, as guest poster Howard Brody points out at http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html.
4)  a lot of sensible regulation of this industry's product quality.

-- SS

Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2

At "Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?" just yesterday, on August 5, 2013, I wrote about a Siemens EHR "glitch" worse than any paper records system problem.  Typed order changes in the medication reconciliation process on patient discharge are disappearing into thin air, unknown to the clinicians typing the orders.  This is likely due to an issue such as some programmer forgetting to put in a statement to write the text to disk, complicated by software testing problems that missed the defect.

I noted:

... "Glitch" is a banal term used by health IT extremists (those who have abandoned a rigorous scientific approach to these medical devices as well as basic patient protections, in favor of unwarranted and inappropriate overconfidence and hyper-enthusiasm).  The term is used to represent potentially injurious and lethal problems with health IT, usually related to inadequate software vetting and perhaps even "sweatshop floor in foreign country directly to production for U.S. hospital floors" development processes (this industry is entirely unregulated).

 
Paper records may have illegible writing that would generally cause the reader to make a phone call or otherwise contact the writer, but those events are one-offs.  EHR defects potentially affect hundreds of installations and thousands of patients, en masse.  (If patients are not dying en masse from such errors, then the whole argument against paper and for IT on the issue of vastly improved safety goes out the windows, but that's an argument for another time.)

Siemens has just released another "glitch" announcement, this time with CPOE (computerized order entry):

(Medication orders "glictch" safety complaint.  Click to enlarge, text below)

Text is as follows:

August 2, 2013

Safety Advisory Notification

Soarian® Clinicals Medication Orders, Safety Complaint ID# EV06643783

Dear Customer:

This notification is to inform you that the Soarian Clinicals Medication Orders may not be operating properly in some cases in Soarian Clinicals 3.3 Service Pack 6 and above.

I note that "glitches" are not uncommon after software patches and upgrades.  See examples at the query link http://hcrenewal.blogspot.com/search/label/glitch.   This reflects inadequate vetting of the patches.

I also note that "medication orders not operating properly" is a very, very serious matter.

Although this may affect only some customers, we are taking a conservative approach and are alerting you to this potential problem. As such, please forward this notification to appropriate personnel as soon as possible.

"May only affect some customers?" (I suspect from this double-indefinite that who is affected is not rigorously known).  "Taking a conservative approach?"  I ask:  what would a non-conservative approach entail?

This letter is being sent as a precautionary measure as there have been no adverse events reported from customers.

Again, they mean "yet."

When does this issue occur and what are the potential risks?

The issue occurs while placing medication orders. In certain cases, when users select orders from predefines or personal favorites and make changes on the order detail forms, the changes are correctly saved and displayed on the forms but the Order As Written (OAW) is not refreshed to reflect the changes. The incorrect OAW is displayed in Siemens Pharmacy in the Order As Written window but the discrete order details are correct. As a result dispensing or administering relying solely on the OAW prior to pharmacy validation may result in error.  [Putting patients directly in harm's way, patients who never consented to the use of these experimental and unvetted medical devices - ed.]  Once the order is validated the OAW in Soarian is updated correctly.

This problem - manually changed data apparently not written to disk - seems similar to the "digital disappearing ink" med reconciliation bug in the aforementioned Aug. 5, 2013 post.

Immediate steps you should take to avoid the potential risk of this issue:

To prevent this issue from occurring at your facility, dispensing or administering of unvalidated order should rely on the order details displayed. Secondly, any deviations from the predefined or personal favorites should be phoned in to pharmacy as a verbal order. During validation, if the pharmacist sees a discrepancy between the order detail and the OAW, verbal follow up with the ordering physician is required.

Again, a workaround.  How many times will this workaround be forgotten, compared to issues of illegibility in a paper record resulting in a phone call to the writer?

Steps that Siemens is taking to correct this complaint:

We are diligently working to develop a correction and will test and deliver it as soon as possible.

Perhaps they should have been working more diligently to detect the "glitch" before it went live.

Also, perhaps the touted power of EHRs to reduce medical errors needs to be re-examined.  Considering bugs like these - creating en-masse problems far worse than possible with paper (another en-masse example at http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html) - then, if the EHRs are so essential to safety, one would expect significant morbidity and mortality from these defects.

If one is to believe patients are not being injured by "glitches", then the expenditure of hundreds of billions of dollars for these systems on the basis of "error reduction" compared to paper is likely a waste of money and resources.

--  SS

Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?

Yes, it can.

There's been yet another "glitch" in the world of health IT (see http://hcrenewal.blogspot.com/search/label/glitch for more examples).

"Glitch" is a banal term used by health IT extremists (those who have abandoned a rigorous scientific approach to these medical devices as well as basic patient protections, in favor of unwarranted and inappropriate overconfidence and hyper-enthusiasm).  The term is used to represent potentially injurious and lethal problems with health IT, usually related to inadequate software vetting and perhaps even "sweatshop floor in foreign country directly to production for U.S. hospital floors" development processes (this industry is entirely unregulated).

This from Siemens Healthcare:

Click to enlarge.  Text below.

Text of this "Safety Advisory Notification":

August 1, 2013

Safety Advisory Notification
Soarian® Clinicals Medication Reconciliation EV06736602

Dear Customer:

This notification is to inform you that Soarian Clinicals Medication Reconciliation 3.3 may not be operating properly in some cases.

Although this may affect only some customers, we are taking a conservative approach and are alerting you to this potential problem. As such, please forward this notification to appropriate personnel as soon as possible.

This letter is being sent as a precautionary measure as there have been no adverse events reported from customers.

They mean "no adverse events reported - yet."  And if such events had been reported, Siemens would most certainly not make them public.  (Why should they, when there are no regulations?)

When does this issue occur and what are the potential risks?

This issue occurs when a user moves a free text in-house order from the current and home medications side (left side) to the discharge medication side (right side), and then modifies the continued free text in-house order in discharge reconciliation prior to saving the discharge reconciliation list. After the modification of the continued free text medication order, the changes to the free text medication order are not recorded in the saved discharge medication list.  [In other words, the changes to medication orders the user just typed disappear into thin air.  I note that medication reconciliation failures are among the most common causes of medical error - ed.]

The health IT extremists would invoke the "Leaned Intermediary" doctrine that lays all blame for errors on the user.  It seems the only way to avoid such liability would be after every "enter" or "save" action (or perhaps every keystroke?), users then verify what was saved or entered...

The "fix" to this "glitch" is not too far off from that:

Immediate steps you should take to avoid the potential risk of this issue:

To prevent this issue from occurring at your facility, instruct users not to modify continued free text in-house orders on the discharge medication list. Users may be instructed to enter free text in-house orders manually by selecting the add prescription action button and entering the order.

This is known as a "workaround."  Anyone who believes this edict can and will be 100% reliably followed in often chaotic medical environments, by users from medical students to nurses to physicians, is truly cavalier.

Steps that Siemens is taking to correct this complaint:

We are diligently working to develop a correction and will test and deliver it as soon as possible.

Perhaps FDA and Joint Commission need to inquire about exactly what testing and QC was done on the current code, testing that (if actually performed) did not detect this glaring and Siemens-admitted safety-risk "glitch."

-- SS

RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals

Add the following from Sutter East Bay Hospitals to nurses' and physicians' complaints at Marin General Hospital (http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html), Affinity Medical Center (http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html), Contra Costa County (http://hcrenewal.blogspot.com/2012/08/contra-costas-45-million-computer.html), San Francisco Department of Public Health (http://hcrenewal.blogspot.com/2010/11/avatar-fails-no-not-cameron-movie-but.html), and others:

For Immediate Release 
July 11, 2013
Contact-  Charles Idelson, 510-273-2246

RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals

Introduction of a new electronic medical records system at Sutter corporation East Bay hospitals has produced multiple problems with safe care delivery that has put patients at risk, charged the California Nurses Association today.

Problems with technology are not unique to health care – pilots of the ill fated Asiana airline that tragically crashed at San Francisco International Airport July 6 told federal investigators that an automatic throttle failed to keep the jetliner at the proper speed for landing, the Los Angeles Times reported July 9.  [What is unique to healthcare IT is the complete lack of regulation - ed.]

In over 100 reports submitted by RNs at Alta Bates Summit Medical Center facilities in Berkeley and Oakland, nurses cited a variety of serious problems with the new system, known as Epic. The reports are in union forms RNs submit to management documenting assignments they believe to be unsafe.

Patient care concerns included computerized delays in timely administration of medications and contact with physicians, ability to properly monitor patients, and other delays in treatment.  Many noted that the excessive amount of time required to interact with the computer system, inputting and accessing data, sharply cuts down on time they can spend with patients with frequent complaints from patients about not seeing their RN.  [Note: patients are not given the opportunity for informed consent about the risks, nor opt-out of EHR use in their care - ed.]

"EPIC is a system that is so cumbersome to use for nurses and physicians, that we often feel as though we are caring for a computer, not a patient,” said Thorild Urdal, an RN at Alta Bates Summit’s hospital in Berkeley. “It delays care and treatment, the program is naturally counter-intuitive and it was clearly not designed in concert with nurses and physicians." [Clinicians end up caring for an "iPatient", as others have noted - ed.]

"The Epic program developed and implemented by Sutter is neither nurse or patient friendly,” said Alta Bates Summit Oakland RN Mike Hill. “Epic does not enhance my ability to chart instead it takes time away from the bedside and my patients and preventing me from providing the absolute best care that they and I expect from me as a nurse."

Sutter CEO Pat Fry last year told the San Francisco Business Times that Sutter will spend $1 billion on Epic, a system that has sparked controversy at several other hospitals, including a Contra Costa facility where several RNs cited serious medical errors in testimony to county supervisors last August.

At Alta Bates Summit specific incidents directly related to Epic problems included:

• A patient who had to be transferred to the intensive care unit due to delays in care caused by the computer.  [It's happenstance they did not have to be transferred to the morgue - ed.]
• A nurse who was not able to obtain needed blood for an emergent medical emergency.
• Insulin orders set erroneously by the software.
• Missed orders for lab tests for newborn babies and an inability for RNs to spend time teaching new mothers how to properly breast feed babies before patient discharge.
• Lab tests not done in a timely manner.
• Frequent short staffing caused by time RNs have to spend with the computers.
• Orders incorrectly entered by physicians requiring the RNs to track down the physician before tests can be done or medication ordered.
• Discrepancies between the Epic computers and the computers that dispense medications causing errors with medication labels and delays in administering medications.
• Patient information, including vital signs, missing in the computer software.
• An inability to accurately chart specific patient needs or conditions because of pre-determined responses by the computer software.
• Multiple problems with RN fatigue because of time required by the computers and an inability to take rest breaks as a result.
• Inadequate RN training and orientation.

These "incidents" are certainly capable of causing harms or fatalities.  One wonders if hospital executives are providing the usual refrain that these are just "glitches" (http://hcrenewal.blogspot.com/search/label/glitch) and that patient care has not been compromised (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).

A bit more background follows:

... Hospitals nationally are spending tens of billions of dollars on technology systems, especially on electronic health records (EHR) programs for which they also receive federal financial incentives.

EHR programs are paraded as a panacea for reducing medical errors and cutting costs, but in life the promise is falling short in both areas.

A RAND corporation analysis earlier this year said visions of savings and improved efficiency in patient care have had what the New York Times called “mixed results, at best.”

The U.S. Food and Drug Administration has acknowledged getting hundreds of reports of problems involving health information technology including numerous patient injuries and deaths.

Some examples seen at hospitals across the country:

• At Marin General Hospital in Northern California, RNs called on the Marin Healthcare District board to delay implementation of their EHR system. "Orders are being inadvertently passed to the wrong patients. People have gotten meds when they've been allergic to them. This is dangerous," Marin RN Barbara Ryan said in comments reported by the Marin Independent Journal.
• In Chicago, the Chicago Tribune in 2011 reported on a patient death at Advocate Lutheran General hospital after an automated machine prepared an intravenous solution containing a massive overdose of sodium chloride — more than 60 times the amount ordered by a physician.
• At Affinity Medical Center RNs in Massillon, Oh. RNs in June raised multiple objections to the hurried introduction of an EHR system. Subsequently, they have cited medication errors, delays in care, problems with documentation, computers crashing, and other concerns.

I am simply the reporter here.

-- SS