"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

Marin General Hospital nurses warn that new computer system is causing errors, call for time out

- Posted on the Healthcare Renewal Blog May 17, 2013 -

Of course, the ever-present euphemism for life-threatening EHR malfunctions and defects, i.e., "glitches" are the cause (http://hcrenewal.blogspot.com/search/label/glitch):

Marin General Hospital nurses warn that new computer system is causing errors, call for time out

By Richard Halstead
Marin Independent Journal
Posted:   05/15/2013 04:07:49 PM PDT

Nurses at Marin General Hospital have asked administrators to put implementation of a new computerized physician order entry system on hold until glitches can be worked out and more training provided to nurses and doctors who use it.

Nearly a dozen nurses attended the regularly scheduled meeting of the Marin Healthcare District board Tuesday night at Marin General to voice their concerns. The district board oversees Marin General, but it does not involve itself in the hospital's day-to-day operations.

"Orders are being inadvertently passed to the wrong patients. People have gotten meds when they've been allergic to them. This is dangerous," said Barbara Ryan, a Marin General registered nurse, who works in pediatrics and the intensive care nursery. "We're not asking you to get rid of it. We're asking you to place it on hold."

Orders passed to wrong patients?  No problem, just a glitch!  Meds people are allergic to?  Just a glitch.  Dangerous?  No way.  It's just a glitch!

But Lee Domanico, who serves as the CEO of both Marin General and the Marin Healthcare District, said, "I'm confident that in spite of the implementation issues, we have a system today that is safer for patients than our old paper system, and it will get even safer as we gain experience with it and work to fix some of the glitches we've experienced."

Where's the data backing up that assertion, I ask?  The actual risks of paper records don't seem to be robustly documented anywhere.

Ryan, who serves as the California Nurses Association/National Nurses United representative, was one of four Marin General nurses who spoke during the public comment portion of the meeting. Ryan said the nurses warned in advance of the system's roll-out on May 7 that nurses and doctors had insufficient knowledge of the system. Ryan said due to problems with the software nurses had been unable to open the program at home to practice using it.

And yet the rollout happened anyway?  That seems to me to be reckless indifference to the concerns of clinicians.

"Lo and behold the problems that we were worried about have happened," Ryan said. "We're looking at two-hour preps for surgery and two- to three-hour discharges; skilled nursing facilities calling back saying, this really doesn't make sense; the wrong meds ordered on the wrong patients and then given to the wrong patients; the inability for nurses to be able to see what the doctor ordered and double-check it."

Of course, I might add, patient safety was not compromised, the other common refrain of EHR glitch-excusers ... see below.

Ryan said nurses have and will continue to file "assignment despite objection" forms due to the system. Nurses file the forms to document formal objections to what they consider an unsafe, or potentially unsafe, patient care assignment.

"We will take patients but we will object to the assignment because it is unsafe," Ryan said. "This system is making it unsafe."

These will be exceptionally helpful in court to any patients injured or killed as a result of these "glitches" and EHR rollout that occurred despite direct warnings from clinical experts.

Marin General nurse Susan Degan said, "This is not about resistance to change. It's about accountability. My most important role is that of patient advocate. I am held accountable when errors are made."

Domanico acknowledged there have been some technical problems with the Paragon system, including making it possible for nurses to open from home. And he said the software is not faster than the old paper system.  [Considering it's acknowledged all the way up to the highest levels of HHS that current EHR's slow physicians down, one wonders if anyone in this organization thought an EHR would actually increase speed? - ed.]

About the "resistance to change" canard, see my essay "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html .

"So yes," Domanico said, "it is causing stress for nurses who have heavy workloads, who are learning how to use it, particularly in areas where we need to speed up the computer."

What?  "Speed up the computer?"  They've spent tens if not hundreds of millions for an EHR, and the computer's too slow?

Actually, I think what this CEO in an obvious display of health IT ignorance is trying to say is that we have to do something about the system's poor usability, which sort of mimics what the Board Chair of the American Medical Assocation just said (http://hcrenewal.blogspot.com/2013/05/ama-finally-on-board-with-ehr-views.html).

Also - clinician stress promotes error.

But Domanico challenged the suggestion that patient safety at Marin General had been compromised.

In fact, there is no way the issues described above cannot be compromising patient safety, on its face. (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).

"I would have no hesitation about entering this hospital tonight," he said.

As a VIP, of course, this CEO would get special treatment.  Thanks a lot.

I would NOT want to be a patient there under these conditions, unless perhaps I had a 24x7 medically-skilled advocate/bodyguard.

Board member Ann Sparkman, who previously served as in-house counsel at Kaiser Permanente, said nurses at Kaiser struggled at first when a new computer system was introduced there.

Sparkman said, "It's just to be expected."

This seems a rather bizarre appeal to common practice (http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html).

The stunning ignorance of this board member about proper mission-critical IT safety testing and implementation, such as performed in pharma, aerospace, etc. is, quite frankly, shocking.

Further, an attitude that life-threatening "glitches" are "just to be expected" by a member of the Board of Directors, with fiduciary responsibilities regarding hospital operations, is grossly negligent in my opinion, and completely ignores patient's rights.

Unbelievable.

One wonders if any formally-trained medical informatics experts were in leadership roles in this project.

-- SS

Financial woes at Maine Medical Center: Reading this blog might have saved them millions of dollars, and prevented massive "cost saving initiatives"

In this article, the euphemistic and almost endearing term "hiccup" is used instead of the more traditional "glitch" to describe obvious major information technology malfunctions.  It is likely the knowledge at this blog and at my health IT dysfunction teaching site could have helped prevent most of these problems:

Financial woes at Maine Medical Center
New England health system facing $13 million loss, initiates plan to save $15 million
NEW GLOUCESTER, ME | May 2, 2013

In a memo to its employees last week, one of Maine’s largest health systems said it has suffered an operating loss of $13.4 million in the first half of its fiscal year.

“Through March (six months of our fiscal year), Maine Medical Center experienced a negative financial position that it has not witnessed in recent memory,” Richard Petersen, president and CEO of the medical center, wrote in the memo to employees. A copy of the memo was sent to MedTech Media, publisher of Healthcare Finance News.

A "negative financial position" (translation: we lost big money) that it has not witnessed in recent memory?  What are the reasons?

In order to bring the medical center to breakeven by year’s end, the health system’s leadership has determined $15 million needs to be saved.

In the memo, Petersen said the operating loss is due to declines in inpatient and outpatient volumes because of the hospital’s efforts to reduce readmissions and infections; “unintended financial consequences” due to the roll out of the health system’s Epic electronic health record and problems associated with being unable to accurately charge for services provided; an increase in free care and bad debt cases; and continued declining reimbursement from Medicare and MaineCare, the state’s Medicaid program.

That rings a familiar tune - from the mid 1990's at Yale, as well as more recently.

Many of the reasons for Maine Medical’s financial woes are similar to those hospitals across the country are facing.

A recovering national economy, continued budget restrictions and restraint and the realization that, while electronic health records may have efficiencies and cost savings over time, the costly transition to EHRs may take years to recoup.

Especially when not done well.

In his memo to employees, Petersen said the hospital has identified many of the hiccups contributing to the charge capture problems and a team of hospital employees and Epic technicians are working to resolve those issues. In the meantime, the remaining roll out of the Epic EHR to the rest of the health system is on hold.

Hiccups? Health IT has a euphemistic language all its own.  Only apostates would dare to call the "hiccups" for what they really are, in medical parlance:  IT malpractice.

To save $15 million by year’s end, Maine Medical is immediately instituting a number of cost-saving initiatives including selective travel and hiring freezes, putting the operating contingency budget on hold and reducing overtime. Petersen appealed to employees to curb discretionary spending and contact management with any cost-saving ideas.

All, of course, will have no impact on patient care....

“I’m confident that we’ll confront this test, beat back the issues we face, and reverse this negative financial picture,” Petersen wrote in the conclusion to the memo.

Test?  Test of what, IT competence?

Of course, "C" officers would never write that "I'm not confident we'll confront our screwups."

Maine Medical did not reply to an interview request by deadline. The Maine Hospital Association declined to comment for this story.

Silence is golden.

A newspaper letter from Stuart Smith, Selectman, Town of Edgecomb, St. Andrews Regional Task Force (a software developer himself) tells more:

STUART SMITH'S LETTER TO THE REGISTER
Wednesday, May 1, 2013 - 7:30pm
Save St. Andrews Hospital

As the Boothbay Peninsula moves forward with the effects of a MaineHealth/Lincoln County HealthCare decision to close St. Andrews Hospital, I have served on the 4 Town Regional Task Force. This has been an unprecedented cooperation between 4 towns in this region that has generated many continuing activities that will benefit all towns in our region.

Apparently an entire hospital is closing as a result of these debacles.

[May 8, 2013 addendum: a family physician in Lincoln County where St. Andrews hospital is located and a member of the Board of Trustees, Dan Friedland, M.D., writes me that the EHR had nothing to do with the hospital closing - ed.]

But let me get back to the MH/LCH decision. We are told that MaineHealth has spent over $150 million on an Electronic Medical Records (EMR) system that helps all of its “subsidiaries.” I can appreciate this because my work is in software development.

I do question the $150 million figure. I think it is extremely high and Portland has had a real failure in its implementation. So much so that it looks like LCH will not have a real integrated EMR until 2015 and financial software problems exemplify a major failure of MH to create any real benefit to the State. Millions of dollars have been charged to member hospitals and staff time (salaries and mileage) over the past 2-3 years with no benefit.

I'd questioned the high cost of these commercial EHR systems as far back as 2006 ("Yet another clinical IT controversy: UC Davis" and "External oversight needed for hospital EMR implementation?" - Lancaster General Hospital and "$70 million for an Electronic Medical Records system [quasi endpoint]?- Geisinger).

One might think healthcare systems have money to burn ...

The system failure also adds operational costs going forward that were not planned for and regional consolidation of finance will now be delayed. The cost to Maine Health Center is huge in improper service and supply charges. Information Technology leadership has been fired, but MH administration is truly accountable.

For once, someone in IT leadership did not get a a promotion for failure.  It is true that MH administration is accountable, however - they had the fiduciary responsibility to hire the best talent, and to oversee that talent as needed to assure success.  If "C" leadership didn't understand IT, that's their failure as well.  In my view in 2013 everyone in a position of organizational responsibility should have a good understanding of IT, which is now, after all, a commodity.

I'm hopeful EPIC, with its apparently revolutionary hiring practices akin to the hiring of physicians, will have the "hiccups" fixed in no time.  From this link at the "Histalk" site on staffing of health IT projects, Aug. 16, 2010. Emphases mine:

Epic Staffing Guide

A reader sent over a copy of the staffing guide that Epic provides to its customers. I thought it was interesting, first and foremost in that Epic is so specific in its implementation plan that it sends customers an 18-page document on how staff their part of the project.

Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say.  The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores.

I am forwarding links to this post, blog, my teaching site (begun in 1998) and additional material to Selectman Smith.

I'd offer to help, but the management of the organization would likely find, as did management at this one (a major denominational chain), that I have too much experience for the organization.

-- SS

Healthcare computing 'glitch' time again: 15 patients possibly given wrong antibiotic after lab error at Regina General Hospital

Just another computer "glitch", that innocuous euphemism for a catastrophe-promoting IT defect, this time causing patients to receive the wrong antibiotics:

Regina Leader-Post
April 17, 2013

15 patients possibly given wrong antibiotic after lab error at Regina General Hospital 

Fifteen patients in southern Saskatchewan were potentially treated with the wrong antibiotic stemming from a lab error at Regina General Hospital, the Regina Qu'Appelle Health Region announced Tuesday.

According to the RQHR, lab reports between late January and late March erroneously deemed Clindamycin would effectively treat the patients' infections when those bugs were actually resistant to the drug.  [The biological bugs, not the cybernetic bugs, that is - ed.]

Only one of the 15 patients suffered adverse effects. The 15th patient, an adult male, experienced short-term negative effects but has since been switched to another antibiotic. Citing patient confidentiality, the health region would not elaborate on the man's condition.

Dr. Jessica Minion, a medical microbiologist in the General Hospital's laboratory, said a computer glitch caused the faulty reports between Jan. 23 and March 28. 

Need I add that this "glitch" could very easily have killed people?

Minion added she and other medical staff will now cross-check lab reports against lab tests after a change has been made within the computer system.

Wait - if the "glitch" is fixed, why is cross-checking still needed?  Doesn't sound like there's much confidence in this computing system...

The lab became aware of the problem on March 28 when the doctor treating the man who experienced problems notified the hospital, Minion said. Lab staff then sifted through records and determined a total of 15 people had been prescribed Clindamycin since the erroneous reports began Jan. 23. 

Clindamycin itself is not an innocuous drug, with many potential serious side effects.

"It was a very identifiable mistake that was being made in the computer system, and there is a very clear trail of who exactly it affected," she said. "So we are quite confident that we have identified everybody that would have been affected."

Only by the grace of God, none of those affected are six feet (2 meters) under, either due to their primary infections or drug adverse events from a drug they should never have been given.

At least this time the oft-heard refrain "but patient safety was not compromised" was not proffered.

-- SS

Boulder Community Hospital computer records back on line - but something does not add up

This post is in followup to my March 20, 2013 post "Boulder Community Hospital computer system crash: Either you're in control of your information systems, or they're in control of you".

At a March 24, 2013 Denver Post article "Boulder Community Hospital computer records back on line" the following statements are made:

The computer system that Boulder Community Hospital uses to manage patient records, which had been down for almost two weeks, is now up and running again, hospital officials said Saturday.

Meditech, the system used by the hospital to manage patient records, went down March 12 and affected the hospital, its Foothills campus, eight laboratories and six imaging centers. It was put back into full service at about 3 p.m. Friday, according to hospital spokesman Rich Sheehan.

Sheehan said an investigation showed the outage was a result of a malfunction in one of the main computer servers ... the hospital has replaced the hard drives for the server that failed and are inspecting the remaining servers ... [the failure] resulted in the system being unable to access patient information. The malfunction affected both the primary server and a backup server kept off-site.

A hard drive failure led to a two-week outage of an entire EHR system and its offsite backup server?  A mission-critical system in a hospital is so fragile that a hard drive failure caused a two week outage?

If so, that itself shows, at best, poor overall system design with regard to reliability and redundancy (any server worth its salt has hard drives in a failure-tolerant configuration e.g., RAID), but also is not quite credible on its face.  A remote server should not be taken down by the failure of a local server.  I suspect the failure was more than just a hard drive failure, including software bugs or configuration errors, mass hardware and/or network failure, or even sabotage.

The following statement also lacks believability on its face:

... All patient data was recovered except for an eight-hour period the day of the outage. Sheehan said the hospital had to re-create, re-enter and validate the patient information for that eight-hour period before the system could resume normal operations.

If an information system is down for two weeks, there's two weeks worth of data lost.

... Sheehan said the hospital has replaced the hard drives for the server that failed and are inspecting the remaining servers. The hospital is also now doing data backups every four hours as opposed to every six hours, and is planning on doing hourly backups by the end of the week.

Replacing a failed hard drive is an inadequate precaution.  A 'system redundancy makeover' seems in order for when the next hard drive fails.   Hard drives have a very well known MTBF (mean time between failure) and annual failure rate.  (The very Seagate ST3750528AS hard drive in the PC I am typing this blog post on has an Annualized Failure Rate of 0.34%, per the manufacturer's publicly-available literature.) 

... An independent consulting firm also has been hired to conduct an investigation. The hospital said it expects a report within a few weeks. 

As other organizations are using Meditech products, Joint Commission Safety Standards (as I wrote in a 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" available at this link) call for sharing the results of that report with other organizations.  I had discussed this letter numerous times with senior Joint Commission leadership.

Will sharing of the independent consultant firm's report happen?  Probably not.

However, rest assured the Plaintiff's attorneys of Colorado will request it in malpractice suits that arose during the time period of outage.

-- SS

Boulder Community Hospital computer system crash: Either you're in control of your information systems, or they're in control of you

Yet another health IT crash, "prolonged" this time, from some unspecified "glitch":

Boulder Community Hospital computer system crash frustrates patients
Officials say it could take until Friday for outage to be resolved
By Brittany Anas
Camera Staff Writer
Posted:   03/18/2013 07:23:23 PM MDT
Updated:   03/18/2013 07:24:16 PM MDT

A prolonged computer system outage is preventing Boulder Community Hospital from accessing patient records -- making it difficult for people to schedule surgeries, get test results and make appointments for routine blood work.

Meditech, the system used by the hospital to manage patient records, went down in the middle of last week. It could take the hospital until Friday to get the system back up, said Rich Sheehan, spokesman for Boulder Community.

That fits my definition of "prolonged."

While information technology officials are investigating what caused the outage, Sheehan said patient records are protected and hospital officials don't believe they've been hacked. 

That's not very reassuring, considering the length of the outage.

The outage affects the hospital, its Foothills campus, eight laboratories and six imaging centers. 

Patients are on its face put at-risk ... for example, I know of several deaths of infants and adults from delayed x-ray reports alone ... but the clinicians, not the IT seller or hospital IT staff, are liable.

"We know medical care is important to people, so we understand the concerns those in the community have," Sheehan said. "We have a lot of people working on this, doing the best they can to solve this problem in a safe manner and as quickly as possible." 

"We know medical care is important to people?"  No, really?

In the meantime, the hospital is using manual paper record-keeping systems and traditional paper charts for its inpatients. Hospital officials say the system allows them to continue treating patients, provide diagnostic services and collect important clinical information that will be entered later into each patient's electronic health record.

But that concerns Eroca Lowe, whose mother was in the hospital Thursday through Sunday with gallbladder pain.

Lowe said the outage made it extremely difficult for doctors and nurses to do their jobs while hunting down lab results. She criticizes the hospital for not having a backup computer system and resorting to paper records.

"That's not a hospital in 2013," she said.

It's a good bet the paper records and HIM personnel managing them are not what they used to be pre-computer.

... Dina Huber said it took her and her significant other six days to schedule an appointment for a hernia surgery because the system used for scheduling is down.

"If they can't keep their computer system running, how can we trust them to perform surgery?" Huber said.

Fortunately, surgeons perform surgery ... not computers, IT staff or management.  Doctors, as the enablers of healthcare, don't need computers to save lives.

However, making their job harder is not a good idea.

A physician who works at Boulder Community Hospital, speaking on the condition of anonymity, said he doesn't think the outage is compromising the health or safety of patients. But, he said, the backup response "seems a little haphazard, and it's not an organized plan." He said physicians are left chasing down records.

If a prolonged outage "is not compromising safety", then why did the hospital spend tens of millions on computers?

Sheehan said the hospital is prioritizing accuracy and patient safety while getting the records system up and running. 

Once it's running again, there is significant risk of data now recorded manually being lost, thus again increasing error risk.

"We apologize for the delays, but this was an unavoidable situation," Sheehan said.

("We apologize for the chilly water, but this was an unavoidable situation." - Captain of the HMS Titanic?)

If an injury occurs, how will that sound to a jury?

Let me answer that:  like bull***.  

My response to Mr. Sheehan and Meditech, and the IT personnel involved:  "Either you're in control of your information systems, or they're in control of you."

It seems the latter clearly applies here.

I pray nobody gets injured ... and that the principals don't end up before plaintiff attorneys I've educated on the issues of bad health IT.

-- SS

When "Human Error" Causes EHR Downtime, Who is Liable For Patient Injuries That Result?

In the Pittsburgh Post-Gazette was this story of yet another EHR "glitch":

March 9, 2013 12:17 am 

Human error the cause of UPMC electronic issue

A systemwide problem with UPMC's information systems Wednesday left electronic patient records and other data inaccessible for about three hours. A UPMC spokeswoman said the hospitals "immediately went to manual backup systems, and we quickly identified and fixed the problem." She said there was no indication that patient care was compromised by the incident, which was due to human error.

I will presume the "human error" was not a physician or nurse pressing the wrong button, but a "human error" involving the servers or IT infrastructure such as a botched system upgrade, action that caused a server room power fault, etc.

UMPC is a very large system as their webpage shows, showing approximately fifteen major facilities.

The now-expected "patient care has not been compromised" line was provided to the Gazette, a line so commonly heard after EHR outages that I  use it as a Healthcare Renewal indexing tag (see this query link).

The following questions arise:

• What, exactly, was the "human error" and why was there no fault tolerance built into these mission-critical systems to account and compensate for it, such as via redundancy?

• If paper is so bad as a record-keeping medium that hundreds of billions of dollars are being spent to replace it, then how can patient care not be compromised, especially when multiple hospitals unexpectedly and without warning have to return to its use? 

• How can a very large hospital system rapidly declare that "patient care was not compromised" without a thorough and comprehensive patient review, accounting for possible delayed negative outcomes (by way of just a few simple examples, due to medication or imaging delays?)

•  Who is liable for any adverse patient outcomes that occurred related to the sudden unavailability of past records:  the clinicians?  The "human" who committed the computer-related error?  The corporation, either for direct negligence in implementing and mandating use of a system prone to mass outage by human error, or vicariously for the negligence and/or misconduct of its information technology employees and/or agents?

•  How many "outages" will it take before some patient is outright, no-doubt-about-it harmed or killed?  Do we want to find out, or is a priority to have redundancies so these systems don't crash?

I, for one, would not want to have a family member be "crashing" at the time of a sudden, unexpected system-wide EHR outage.

-- SS