Physician whose mother had heart surgery reflects on sane EHR use

The following from a physician I know, an ED physician, on the care their mother received at a major academic medical center's teaching hospital using EHR.

Emphases mine:

Mom just had aortic valve at hospital [name redacted] associated with [redacted] Medical School.  EHR used was [major EHR vendor name redacted] but it clearly had been pushed into the background......

1) Every ICU patient also had a printed chart in a notebook (paper) medical record book kept at the nursing station.  Just like the old days. It was the most commonly used source of info to the residents and staff.

2) Not once did I see an EHR physically come between a patient and a staff member (as opposed to nearly every encounter where I work).

3) Mom's (and every ICU patients) plan for the day was outlined in magic marker directly on the glass doors and windows and updated during rounds....available for immediate reference, not buried in an EHR.

4) Her clinical info was accurate....... it was dictated and not fabricated from pick lists or dot phrases.

5) Clerks put in the data and Dr's orders......apparently they long ago figured out the nonsense called CPOE and let the clerks do it.

I suspect many major University hospitals have worked around the workflow barriers and most egregious documentation sins.  The doctors there (at least in that Cardiothoracic ICU) have enough clout that they can just say HELL NO.  Those of us working for less astute/ non cutting edge community hospitals run by "also ran" healthcare corps are left to bear the crosses ONCHIT and the EHR industry have dumped upon us.

I am grateful to the folks at [hospital] for an excellent job on my mom and demonstrating that efficient healthcare pushes the EHR (as currently sold and configured) to the back burner.

Oh, [EHR name redacted] still is loaded with those prefilled templates and copy/ paste pull forward geared for upcoding.....but these "top of the food chain" docs just didn't waste their time with them.

Having had to gut and remediate really, really terrible health IT for invasive cardiology and cardiac surgery years ago (http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story), and revise workflows to relieve busy clinicians with critically-ill patients from the stupidity and time-sink of fiddling with balky computers with poorly-designed software, I identify with this physician's observations and beliefs.

As I've stated in previous posts, most clinicians need to be relieved of clerical tasks associated with computers, especially data entry and ordering, not just surgeons.

If the data is really that valuable, hiring clericals to do clerical work should remain a true bargain, with massive return on investment.

If that is not the case, then the data is really not that valuable.

-- SS

EHR Go-Lives Are Often Chaotic; One Area To Be Explored Is If This Go-Live Led To This Tragedy

EHR "go-lives" are particularly chaotic as staff adjusts to the new cybernetic governor of care.  Could the distractions have caused or contributed to the following tragedy?

http://www.cnn.com/2013/12/17/health/california-girl-brain-dead/

Family wants to keep life support for girl brain dead after tonsil surgery
By Tom Watkins and Mayra Cuevas, CNN
updated 4:32 PM EST, Wed December 18, 2013

The mother of 13-year-old Jahi McMath, who was declared brain dead Thursday, three days after undergoing surgery to remove her tonsils, said Tuesday that the family should make the call.

... The surgery, which occurred December 9 [at Children's Hospital & Research Center in Oakland, California - ed.], initially appeared to have gone well, said Sandy Chatman, Jahi's grandmother who is herself a nurse and saw the girl in the recovery room. "She was alert and talking, and she was asking for a Popsicle because she said her throat hurt," Chatman said.

But Jahi was then moved to the intensive-care unit, and her relatives were denied access to the eighth-grader for 30 minutes; when they finally were allowed to see her, they knew something was wrong. "Upon entry, they saw that there was way too much blood," Chatman said.

"We kept asking, 'Is this normal?'" Sealey said. "Some nurses said, 'I don't know,' and some said, 'Yes.' There was a lot of uncertainty and a lack of urgency."

Sealey said that when Chatman noticed that her granddaughter's oxygen levels were dangerously low, she called for help.

But Jahi went into cardiac arrest. The medical staff performed chest compressions to revive her and gave her clotting medications, but nothing worked.

The girl's brain was severely injured by lack of oxygen.  I am not commenting on the reported dispute regarding removing life support.

I am commenting on my concern about a possible contributory role of a new EHR.

At my Jan. 2, 2014 post "Doctors' Dissatisfaction With EHRs May Be Early Warning of Deeper Quality Problems" (http://hcrenewal.blogspot.com/2014/01/doctors-dissatisfaction-with-ehrs-may.html) I wrote of the distractions that physicians reported were caused by EHR systems such as:

... current EHR technology interferes with face-to-face discussions with patients; requires physicians to spend too much time performing clerical work; and degrades the accuracy of medical records by encouraging template-generated doctors' notes.

I had also noted nurse's concerns of "inevitable" patient injury due to EHR distractions, such as 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),

• my May 30, 2013 post "Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients" at http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html, 

• my June 19, 2013 post "Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday" (http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html),  

• and at other posts citing similar nursing complaints.

The cases cited above involve the "EPIC" EHR, but similar issues arise will most of the current EHR sellers' products, which are unregulated.  

For instance see the ECRI Institute's Deep Dive study of EHR risk at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html. In a volunteer study (i.e., only a fraction of true incidents reported) of 36 ECRI PSO hospitals, 171 EHR-related "events" serious enough to cause harm were voluntarily reported in just 9 weeks.  8 of the "health IT events" were reported to have resulted in patient harm, and 3 were possibly related to patient deaths.  

From a press release from nurses at Affinity Medical Center (Ohio) on the nature of the problems:

... The programs are often counterintuitive, cumbersome to use, and sometimes simply malfunction. Nurses are finding that the technology is taking time away from patients and fundamentally changing the nature of nursing.” ... I’m concerned that the manner in which this technology is being implemented may pose serious disruptions in patient care.”

An open letter from nurses at an Ohio hospital, Affinity, on EHR "threats to patient safety."  Click to enlarge.

The EPIC EHR apparently had just recently "gone live" at Children's Hospital Oakland.

From  "Children's Oakland completes Phase 1 of $89 million electronic records system", Nov 20, 2013 (http://www.bizjournals.com/sanfrancisco/blog/2013/11/childrens-oakland-89m-emr.html):

Children's Hospital & Research Center Oakland has completed the first phase of an $89 million Epic Systems Corp. electronic health records system that links inpatient operations and an oncology/hematology clinic.

Other outpatient clinics are expected to come online in March or April, spokeswoman Melinda Krigel told the Business Times.

... The project's overall cost, $89 million, includes hardware, software and other implementation costs, including a separate SoftLab system that interfaces with the main electronic medical records system, Krigel said.

The official "go-live" date was Nov. 5.

See also the Children's Hospital Oakland Annual Report at http://www.chofoundation.org/assets/files/2012-annual-report.pdf.  On page 21: 

... The Epic system will launch in November 2013 at Children’s inpatient facilities as well as in the Operating Room, the Emergency Department, the Day Hospital, and the Oncology/ Hematology Clinic.

I believe the possibility of clinicians being so distracted by computer data entry duties, and/or communications being impaired by the system's outputs, that this patient was left anoxic for a crucial period of time needs to be investigated.

In my view, in the differential diagnosis of clinical chaos in 2014, the chaos caused by healthcare IT needs to be a consideration.

My concerns may be shown unfounded in this case (I hope they are), and the injuries the result of other factors.  In consideration of the reported complaints from other organizations, however, not conducting an impartial investigating of a role of the new EHR in this tragedy would be, in my opinion, cavalier.

-- SS 

Jan. 5, 2014 Addendum:

From a court document cached here:  http://www.cci.drexel.edu/faculty/ssilverstein/1230rrr.pdf , the following is written at p. 11-12:

... Originally the surgery was uneventful and MCMATH awoke from sedation in the recovery room speaking with hermother, Petitioner LATASHA WINKFIELD asking for a popsicle.  MCMATH was taken to the ICU and her mother was told to wait several minutes while they fixed her IV.

After being told several times that it would be just another 10 minutes, approximately 25-45 minutes after MCMATH was brought into the ICU, WINKFIELD went back and found her daughter sitting up in bed bleeding from her mouth.  It was evident that this had been transpiring for some time.  The nursing staff said “it was normal” and the mother stayed at the bedside as the bleeding grew increasingly worse.  The nurses gave WINKFIELD a cup/catch basin for MCMATH to bleed from her mouth into.  WINKFIELD asked for assistance and was told that this was normal and was given paper towels to clean the blood off herself and MCMATH.

The bleeding intensified to where copious amounts of blood were being expelled from MCMATH’s mouth and then nose.  MCMATH’s stepfather was also present and assisted in the attemps to stem/collect the blood.

Again, WINKFIELD asked for assistance, and a doctor, and was only given a bigger container to collect the blood and, later, a suction device to suction the increasing volume of blood.  The stepfather continued to suction while the mother went and got her mother, a nurse, to take over for her.  The grandmother saw what was happening and made multiple requests, and then a loud demand, for a doctor.

MCMATH shortly thereafter suffered a heart attack and fell into a comatose state.  She later was pronounced “brain dead”… 

"Heart attack" (i.e., primary myocardial infarction) in a 13-year-old sounds far less likely than exsanguination to the point of hypovolemic shock, severe hypotension, and cardiac arrest.  That such events transpired in an ICU, with family present and calling for help, suggests there were major clinician distractions of some sort at play.

A reader wrote me wondering if a new CPOE component could have caused delays in evaluation and treatment. When someone is dying, you simply cannot waste time 'clicking away', they wrote.

A reader also wrote me wondering if an EHR crash occurred at the time this patient was left with family to exsanguinate, causing clinical chaos.

That is a particularly interesting thought.  See the multiple posts at http://hcrenewal.blogspot.com/search?q=ehr+crash. 

In my opinion, these issues require investigation.

-- SS

Yet Another "Anecdote" - Inpatient Results of Electronic Prescribing "Disappointing"

Many of those in the Medical Informatics community, especially the academics in the upper echelons of the American Medical Informatics Association, are not of a risk recognition / risk management mindset.  Typical of academics, they are often also hostile towards dissent from the party line, as you can read about at my post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" at http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html.

The academics, with a few exceptions, have repeatedly conflated scientific anecdotes of supposed positive results from health IT with risk management-relevant incident reports of bad outcomes and 'near misses', as an Australian colleague wrote about, via me, on August 17, 2011 at "Anecdotes and Medicine, We are Actually Talking About Two Different Things" at http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html).

They dismiss the latter incident reports, even when from well-qualified observers, while giving great attention and credence to the former [a few years as a safety manager in a large urban transit authority disabused me of that type of behavior - ed.], when the former conveniently fit their most cherished beliefs about the beneficence and efficacy of today's health IT.  Further, quality or lack thereof of the former type of evidence is often not considered.  See for instance my post of March 9, 2011 "ONC: The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" at http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html for a stunning example of this phenomenon directly from the national leadership of health IT.

In my view, this phenomenon has led to a substantial loss of focus on health IT realities needed in order to remediate the industry and realize the true benefits of which the technology is capable.

Now there's yet another "anecdote" at Med Page Today.com for the experts to chomp on:

http://www.medpagetoday.com/MeetingCoverage/ASHP/43400?utm_source=cardio-meetings&utm_medium=email&utm_content=mpt&utm_campaign=DCH

E-Prescribing: Inpatient Results Disappointing
Published: Dec 12, 2013
By Sarah Wickline , Contributing Writer, MedPage Today

ORLANDO -- Electronic prescription order entry and medication reconciliation reduced some errors in hospital settings but increased others, and did not meet overall expectations, researchers reported here.

After implementation of a computerized prescriber order entry (CPOE) system, one hospital experienced a 29.2% increase in medication dispensation errors (P less than 0.05), Ramadas Balasubramanian, PharmD, PhD, of the Carolinas Medical Center-Pineville in Charlotte, N.C., and colleagues reported at the midyear meeting of the American Society of Health-System Pharmacists.

It is likely these are qualified observers who in fact might be expected to be biased towards showing good results of this technology.

In a second study, another hospital experienced a 12% improvement in accuracy (P less than 0.001) after implementation of electronic medication reconciliation charts, according to Jill Covyeou, PharmD, of Ferris State University in Big Rapids, Mich., and colleagues.

For the tens of millions of dollars likely spent to achieve a mere 12% improvement, one wonders if a far less expensive investment in experienced human resources might not have accomplished the same results or even far better.

For their study, Balasubramanian and colleagues looked at the impact of CPOE on medication errors in a community hospital setting.

At the end of 2011, when the Carolinas Medical Center-Pineville hospital had only 119 beds, officials there implemented the CPOE-CANOPY system. In early 2012, the hospital nearly doubled in capacity to 210 beds and opened the pharmacy to 24-hour operation. The researchers looked at medical errors from October 2008 through October 2012.

The categories of medication errors included: drug omission, administration at the wrong time, unauthorized drug, wrong dose, and wrong form of dose.

Any of which, of course, can harm or kill, I note.

There was a 57% increase in medication doses from prior to the CPOE system to after implementation, but even after volume adjustments, the number of errors per 1,000 dispensed medications still increased by 29.2% (P less than 0.05).

Bad health IT such as CPOE systems designed for (per Joan Ash) "calm and solitary office environments" would be expected to perform more poorly as caseloads increase and clinicians have less time for computer fritter.

Unauthorized drug dispensation and improper dose of medication decreased post-CPOE, but drug omission and administration at the wrong time were responsible for the increase.

Those seem to match the expressed concerns of another large group of "anecdote-profferers", e.g., the nurses at my Nov. 17, 2013 post "Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications 'Only a Matter of Time' in Open Letter" at http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html:

From those nurses' Open Letter to management on health IT risks:

... Some of the concerns that nurses have brought to the attention of management include:

• Medication errors/scanning issues - perhaps the biggest concern of all RNs
• RNs unable to access patient records for hours at  a time
• Incorrect descriptors and inaccurate drop-down menus
• Incorrect calculations in the I&O and MAP [mean arterial pressure - ed.] portions of the chart 
• Inaccurate medication times and the inability of RNs to ensure medications are scheduled correctly
• Endless loops of computer prompts that are unable to be dismissed by RNs in an emergency

Back to the current Med Page Today.com article:

The use of CPOE software created a time cut-off issue that explained the wrong time of administration increase, the study authors told MedPage Today. If drugs were ordered 5 minutes after the cut-off for the morning medication administration, they would not make it to the patient until the evening rounds unless a special alert was sent to the nurse staff.

That is, a time-eating and fragile (and thus potentially dangerous} workaround.  I note that one does not have to work around something that is not standing in their way.

Balasubramanian and colleagues suggested that the lack of flexibility in the CPOE software was responsible for the drastic increase in medication errors, despite the fact that they thought it would improve error rates across the board.

In other words, the software is not truly fit for purpose.  See definition of "bad health IT" below.

... The authors suggested that electronic prescribing would be better with electronic medical records. "[E]lectronic prescribing alone may fail to increase medication list accuracy to the extent we would like," Covyeou wrote.

Replace "may fail" with "in our case, did fail."

The point about adding an EHR is certainly in the category of "wishful thinking."

If the EHRs are bad health IT, I opine the situation would likely get even worse (cf. Affinity Health, above).

From my site at http://cci.drexel.edu/faculty/ssilverstein/cases/: 

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.

In summary, the technology is not a panacea, and can in fact be worse than paper.  Those who blindly ignore that reality and push for mass rollout of this still-experimental technology "no matter what" do not share, in my opinion, the ethics I was taught in Medical School.

-- SS

On Hypervigilance Due to Bad Health IT: "Texting While Doctoring: A Patient Safety Hazard"

An Opinion piece "Texting While Doctoring: A Patient Safety Hazard" appeared in the Annals of Internal Medicine of 3 December 2013, authored by Christine A. Sinsky, MD and John W. Beasley, MD.  Dr. Sinsky is known to me to be what some would call a "heatlhcare IT iconoclast" (more accurately represented by the term "healthcare IT gadfly/realist" IMO).

In the piece the authors comment on the distractions caused by the technology, leading to doctors missing important cues in the exam room and to and impaired problem-solving.  This is part of a larger phenomenon that has been called "skill-degrading" or "de-skilling", e.g., see my April 16, 2010 post "Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee" at http://hcrenewal.blogspot.com/2010/04/health-information-technology-basics.html).  

These effects are likely to be further worsened as more and more clerical tasks such as order entry, the authors point out, get shifted to medical professionals.  To new readers: note that computerized order entry is often a complex and convoluted process; the CPOE systems are most decidedly NOT mere "typewriters for orders."  See, for instance, part 6 of my series on "Mission-hostile health IT" at http://hcrenewal.blogspot.com/2009/02/it-makes-healthcare-easier-is-this.html.

Most of the Annals article is available as a free preview at http://annals.org/article.aspx?articleid=1784295 as of this writing and is worth reviewing.

Article preview, click to enlarge

I found one passage in particular striking, though.  In my ongoing discussions with computer scientist/informaticist/polymath Dr. Jon Patrick at U. Sydney (http://www.healthll.com.au/?page_id=440) , the issue of hypervigilance necessitated by bad health IT came up, and we arrived at the definition of same seen at my teaching site at http://cci.drexel.edu/faculty/ssilverstein/cases/:

Bad Health IT ("BHIT") is defined as IT that 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. 

Note this passage in Dr. Sinsky and Beasley's opinion piece:

"I am always multitasking ... I am entering orders, checking labs, downloading information while I talk to the patient.  It requires chronic hypervigilance, which is exhausting and demands conscious effort to stay in the 'present' with the patient" (Day S., Personal communication.)  Click to enlarge.

I don't know if Dr. Day had seen my materials, but I suspect the exhausting hypervigilance is all too common, just not much publicized due to the secretive, closed, retaliatory-towards-whistleblowers nature of the healthcare IT sector.

I ask:  is this what we really want, in pursuit of some uncertain cybernetic miracle?

I note that the healthcare IT experiment (and the technology is experimental), long usurped from the Medical Informatics pioneers who trained me and put in the hands of commercial interests and those of a mercantile/manufacturing/management computing background, is increasingly a failure.

-- SS

EHR Pastel Madness: Cognitive Overload in Critical Care

It's hard to find public postings that show the crazy and dangerous complexity of EHR interfaces, but I found a presentation at http://www.uiowa.edu/~medtest2/picis/vo_picis.pdf (PDF slide presentation) that demonstrates ths problem well.

These are from a 2006 training presentation on an EHR for Critical Care , where doctors and nurses really don't have the time to wade through complexity like this.   

I can honestly and in fact, with great vigor, opine I would not have wanted to use a tool like this when I was working in intensive care units.  And I'm a Medical Informatics specialist x 21 years...


EHRs have not changed much; in fact with the higher commodity (cheap) screen resolutions available in 2013 compared to 2006, the problem is worse.

Some sample screens:

Click to enlarge

Click to enlarge

Click to enlarge

Click to enlarge

Click to enlarge

And there's more where these came from at the link above.

Insane, in my view, to subject busy, stressed out clinicians to a pastel nightmare like this. 

(And that's assuming the application doesn't lose or corrupt data.)

This is not to single out this particular seller.  Other EHR sellers' products are similarly visually and operationally complex.

But, if you, the reader, like these and think, the more that can be packed in the merrier, bring it on, that's fine with me.  It's your life and limb.

Actually, not - because my life and limb are at risk, too.

See the entire presentation for more.

-- SS

Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications "Only a Matter of Time" in Open Letter

I've written previously about substantial problems nurses at medical centers including Affinity Medical Center, Ohio (http://www.affinitymedicalcenter.com/) and others are having with EHRs, and how hospital executives were ignoring their complaints.  The complaints have been made openly, I believe, in large part due to the protection afforded by nurses' unions.

See for example my July 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" at http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html, and my June 2013 post  "Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday" at http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html, along with links therein to other similar situations.

Particularly see my July 2013 post "How's this for patient rights? Affinity Medical Center manager: file a safety complaint, and I'll plaster it to your head!" at http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html, where a judge had to intervene in a situation of apparent employee harassment for complaints about patient safety risks.

Here's the latest at Affinity Medical Center - an open letter to the Chief Nursing Officer (CNO) dated August 15, 2013.  Images and text below:

Page 1 - click to enlarge (text is below)

Page 2 - click to enlarge (text is below)

The letter to the CNO states (emphases and comments in red italics are mine):

August 15, 2013

Mr. Osterman,

Nurses at Affinity Medical Center are pleased to see that you have responded to our request and provided additional Cerner education classes, but education was only one of many concerns. [I note that education cannot compensate for the toxic effects of bad health IT that is poorly designed and/or poorly implemented, and that it's legally the responsibility of a hospital to ensure all apparatuses implemented and the environment of care are themselves safe - ed.]

Since the implementation nurses throughout the hospital have brought many serious concerns to the attention of both yourself and other supervisors.  When nurses have reported these concerns they have been either ignored or dismissed. It is distressing that Affinity would so blatantly disregard the concern of their RN staff surrounding issues that concern patient safety.  It is clear to direct-care RNs that many of the problems that exist with Cerner are a direct result of the failure to include nurses in the planning stages. [Exclusion of enduser domain experts from health IT development, in 2013, is grossly negligent IMO - ed.]

Some of the concerns that nurses have brought to the attention of management include:

• Medication errors/scanning issues - perhaps the biggest concern of all RNs 
• RNs unable to access patient records for hours at  a time
• Incorrect descriptors and inaccurate drop-down menus
• Incorrect calculations in the I&O [fluid input and output, especially important in very ill patients - ed.] and MAP [mean arterial pressure, used to calculate drip rates of potent drugs that raise or lower blood pressure in critical care, among other things - ed.] portions of the chart 
• Inaccurate medication times and the inability of RNs to ensure medications are scheduled correctly
• Endless loops of computer prompts that are unable to be dismissed by RNs in an emergency 

[It should be apparent that these 'issues' - some due to fundamental design flaws - are quite serious in terms of the harm they can cause, even with the exceptional and stressful RN hyper-vigilance their presence necessitates- ed.]
 
These threats to patient safety cannot continue.  It is only a matter of time before a communication error or a medication error lead to a serious complication for a patient.  These types of errors have the ability to harm every patient and must be addressed immediately. 

[This is not theoretical or unlikely.  Such an error led to my own mother's crippling injuries and death, and to injuries and deaths in numerous other cases of which I am aware through my legal work - ed.]

We ask that you set up a meeting with a delegation of RNs from our Facility Bargaining Council to discuss the concerns that nurses have documented on 'Technology Despite Objection' forms [complaint forms about use of technology with objections - ed.] and make a plan to fix these life-threatening problems.

You may set up a meeting by contacting Pam Gardner, RN at [redacted] or our National Representative  Michelle Mahon, RN.  [For the National Nurses United labor union, http://www.nationalnursesunited.org/, with close to 185,000 members nationwide - ed.]  We look forward to hearing from you.

The letter is followed by the signatures of about 70 nurses.

I am informed by a Union rep in mid-November 2013, 3 months after the date of this letter, that (emphasis mine):

Nurses there are continuing to document the problems and concerns that they are experiencing.  I have attached a letter sent to the CNO at Affinity signed by nearly 70 RNs.  This is a pretty significant number of nurses especially in light of the fact that managers stole the circulating letter two times to prevent nurses from signing on.  The response to this letter was…….nothing.  The nurses have been ignored yet again. [Ellipsis in the original, I did not redact - ed.] 

It is clear the administration of this healthcare system has been clearly put on notice of likely if not imminent danger to patients by multiple qualified experts, its own RNs.  If they do not act and patient harm occurs, it is my belief criminal negligence charges could be merited.

I also highly doubt patients are informed of these EHR system 'issues' and have been afforded the opportunity to give informed consent to the use of these computer systems in their care, or to go elsewhere for treatment.

These problems are repeating themselves over and over across this country and others, but many clinicians, especially those not protected to some degree by a labor union, do not speak out due to fear of retaliation.

Let's hope the nurses who signed this letter don't get their complaints plastered to their foreheads, as some were threatened with as in the aforementioned post.

-- SS

Should "Diagnosing While Texting" Be Illegal?

I saw an interesting comment at Medscape in the comment thread of the article "Do Your EHR Manners Turn Patients Off?" (MedScape subscription required).

Dr. [redacted] | Neurology

I live in a town that has passed legislation criminalizing texting and driving. A driver is more impaired and distracted when texting than when intoxicated.  EHR's and the practice of medicine should be no different. Do you really believe that your physician is actually concentrating on the patient in front of them while their attention is primarily focused on entering data on a computer? The reality is that EHR's true value is data collection for statistical analysis by our government and there is an obvious deficiency for enhancing the physician-patient collaborative experience.

Medicine, like driving, is a very cognition, thinking and concentration-intense activity.   Failures lead to injury and death (although not quite as dramatically in the former compared to the latter).

I think the point about distraction the commenter makes is valid, or at least worthy of healthy consideration.

Unless you're a health IT hyperenthusiast, that is (see http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html).

-- SS

UnitedHealth's Latest Blunders Include Lax Fraud Detection, Recalled EHRs - So Why is its CEO Worth $13.9 Million, or is it $34.7 Million?

We managed to go four months since our last post about UnitedHealth, but sure enough, the company that keeps on giving... examples of poor management to contrast with ridiculous management pay... has done so again.

There were two obvious examples of poor management that recently appeared in the media.

Lax Fraud Dection

The background, as noted in a Kaiser Health News article published in September, is that it is now fashionable for American states to outsource some or most of their Medicaid health insurance programs to managed care organizations, often for-profit, as is UnitedHealth.  These programs are meant to provide insurance to the poor and disabled.  Yet once they have outsourced Medicaid, the states may be reluctant to cancel contracts, even if the outsourcing is not working:

 In Florida, a national managed care company’s former top executives were convicted in a scheme to rip off Medicaid. In Illinois, a state official concluded two Medicaid plans were providing 'abysmal' care. In Ohio, a nonprofit paid millions to settle civil fraud allegations that it failed to screen special needs children and faked data.

Despite these problems, state health agencies in these - and other states - continued to contract with the plans to provide services to patients on Medicaid, the federal-state program for the poor and disabled.

Health care experts say that’s because states are reluctant to drop Medicaid plans out of fear of leaving patients in a bind.

'You probably won’t find many examples of states flat out pulling the plug. That’s sort of the nuclear option,' said James Verdier, a senior fellow at Mathematica Policy Research, a nonpartisan think tank. 

Never mind that leaving such programs as is means taking money meant to finance care for the poor and using it to finance fraud, and reward managed care organizations for failing to find fraud.

One of the examples, but not a new one, used in the Kaiser Health News article, involved UnitedHealth:

Linda Edwards Gockel, spokeswoman for the Texas Health and Human Services Commission, said that in 2009, officials were concerned about a pilot program in the Dallas-Fort Worth area run by Evercare, a subsidiary of UnitedHealth Group. The program, which coordinated care and long-term services for elderly and disabled people, had been fined more than $600,000 for not providing proper access to care and failing to coordinate services.

Gockel said Texas decided to cancel the contract 15 months early, but continued to do business with Evercare because the problems in Dallas-Fort Worth weren’t affecting services it was providing elsewhere.

Then in July, NJ.com reported an investigation by the state of New Jersey into UnitedHealth's ability, or lack thereof, to detect fraud in the Medicaid managed care program it runs for the state.

 An HMO that earned $1.7 billion from 2009 to 2010 by providing Medicaid coverage to 350,000 low-income and disabled New Jerseyans didn't try very hard to detect fraudulent billing — identifying only $1.6 million, or one-tenth of one percent in improper payouts, according to a report the Office of the State Comptroller released today.

UnitedHealth did not even come close to fulfilling its obligations to provide sufficient resources to fight fraud:

The HMOs in the Medicaid program are required to dedicate one investigator for every 60,000 Medicaid clients. At that ratio, United's special investigations unit should have been comprised of about six employees whose sole focus is to detect fraud and abuse by medical providers and patients.

Instead, United reported it had dedicated the equivalent of two investigators during the two-year study period based on the amount of hours devoted to the unit. Upon scrutiny, the comptroller found United 'overstated' its staffing levels; the unit had one investigator, the report said. 

Note that this abject failure appeared to violate the contract UnitedHealth had with the state,

UnitedHealthcare Community Plan of New Jersey failed to hire enough investigators and train them properly, in violation of the managed care company's contract with the state, according to the report. 

Presumably, if fraud led to excess program expenses, it would be New Jersey, not UnitedHealth who ultimately had to pay them.  Again, it appears that money meant of pay for health care for the poor and disabled was diverted to fraudsters, and to revenue for UnitedHealth (partly because the latter did not see fit to spend enough money up front to detect the fraud.)  Of course, such management by UnitedHealth helped to increase its already fat revenue stream.

Faulty Electronic Health Records

In September, Bloomberg reported that UnitedHealth had to recall electronic health record software because of faults that likely increased the risk of bad patient outcomes,

UnitedHealth Group Inc has recalled software used in hospital emergency departments in more than 20 states because of an error that caused doctor’s notes about patient prescriptions to drop out of their files.

Certain versions of the software made by the largest U.S. health insurer had a bug that didn’t print information related to the medication and failed to add data to patients’ charts,according to a document filed with the U.S.Food and Drug Administration and posted July 29.

The technology is used in 35 facilities in states including California, New Jersey, and Florida, the document shows. The recall began June 21. There were no reports of patient harm and each facility was notified and received a digital fix, said Kyle Christensen, a spokesman for the UnitedHealth division that makes the Picis ED PulseCheck software that was recalled.

The incident shows how software errors can create dangers for patients at a time when digital health records are being implemented as a cornerstone of President  Barack Obams's modernization of the nation’s health-care system.

The "bug" could potentially harm patients,

 Doctor’s notes are critical for some medications, as they contain directions about diet and use. Failure to include the instructions could lead to serious injury or death, [University of Pennsylvania adjunct professor of sociology and medicine Ross] Koppel said.

It turns out that the Picis software has had other problems that could have increased the risk of harm to patients,

An online database maintained by the FDA shows that Picis Inc., a Wakefield, Massachusetts-based company that UnitedHealth acquired in 2010 for an undisclosed price, has reported six recalls involving electronic health record software since 2009.

One incident in 2011 involved anesthesia-management software sold nationwide that in one instance displayed a patient’s medical information in another patient’s file. Anotherinvolved software sold worldwide where on an unspecified number of occasions, the program failed to display the discontinued status on medication orders. Others included glitches that caused a failure to display appropriate allergy interaction warnings, the freezing of administrative controls, and other issues.

Note that it is the same Picis software that our blogger, InformaticsMD, has alleged lead to the death of his mother,

Alleged flaws in electronic health records have led to lawsuits. Scot Silverstein, a doctor and health-care informatics professor at  Drexel University, sued Abington Memorial Hospital in Pennsylvania in 2011 over the death that year of his 84-year-old mother. He blamed her death on a flaw in her electronic health record that he claims caused a critical heart medication to vanish from her file. One of the systems involved was made by Picis, according to his lawsuit. Picis is not being sued.

Linda Millevoi, a spokeswoman for Abington Memorial, declined to comment.

The latest InformaticsMD posts on this case are here and here.

Summary

These cases are just the latest in a long list of blunders and ethical missteps made by UnitedHealth and its top management.  The most significant examples of the latter about which we have posted appear in the appendix at the end.  The latest examples likely diverted money that should have supported health care for the poor, and and may have put patients' health and lives at risk.

Yet UnitedHealth is now the largest US health insurance company, and it has succeeded in making its current and former CEO fabulously wealthy.  According to filings with the US Security and Exchange Commission (SEC), its current CEO, Stephen J Hemsley, got $13.9 million in 2012, up from $13.4 million in 2011, as we posted here.  However, an analysis by the Minneapolis Star-Tribune that took into account stock gains and shares vesting suggested he got $34,721,122 in 2012, admittedly down from a breathtaking $48,075,614 in 2011. 

The previous UnitedHealth once was worth over a billion dollars due to back dated stock options, some of which he had to give back, but despite all the resulting legal actions, was still the ninth best paid CEO in the US for the first decade of the 21st century (look here).

So UnitedHealth continues to provide us with examples of how top leaders of health care organizations can become tremendously rich, despite, or perhaps because of repeated mismanagement and apparently unethical management on their watches.  Only when we make health care leaders truly accountable for their organizations, and especially for their organizations' ethics and effects on patients' and the public's health will be begin to challenge health care dysfunction.

(Note to readers recently joining us from countries other than the US - UnitedHealth is a multi-national that claims to operate in 33 countries (look here).  For example, its UK web-site is here.  So beware the export of bad management for enhanced prices.) 

 
Appendix - UnitedHealth's Ethical Lapses

 - as reported by the Hartford Courant, "UnitedHealth Group Inc., the largest U.S. health insurer, will refund $50 million to small businesses that New York state officials said were overcharged in 2006."
- UnitedHalth promised its investors it would continue to raise premiums, even if that priced increasing numbers of people out of its policies (see post here);
- UnitedHealth's acquisition of Pacificare in California allegedly lead to a "meltdown" of its claims paying mechanisms (see post here);
- UnitedHealth's acquisition of Sierra Health Services allegedly gave it a monopoly in Utah, while the company allegedly was transferring much of its revenue out of the state of Rhode Island, rather than using it to pay claims (see post here)
- UnitedHealth frequently violated Nebraska insurance laws (see post here);
- UnitedHealth settled charges that its Ingenix subsidiaries manipulation of data lead to underpaying patients who received out-of-network care (see post here).
- UnitedHealth was accused of hiding the fact that the physicians it is now employing through its Optum subsidiary in fact work for a for-profit company, not directly for their patients (see post here).

A New And Quite Perverse Hospital Ploy to Defend Medical Malpractice - Blame the Dead Patient? Two Examples

I did not think hospitals would ever get to the level of perversity, in defense of EHRs and EHR-related malpractice, seen herein.

Just a few days ago I came across the following article on a web search.

It is an astonishing story of a 49 year old man who died in part because an ED physician in a Suffern, NY hospital did not know how to use the EHR that had life saving diagnostic information within, and the hospital attempted to BLAME THE PATIENT for not "explaining his medical history thoroughly enough" to the ED doctor.

You read that correctly.

Ironically and sickeningly, yesterday my dead mother and I just had something similar done to us by a suburban Philadelphia hospital, Abington Memorial, as below:

Family Awarded $3.4 Million After ER Misses Aneurysm

http://blogs.lawyers.com/2012/02/family-awarded-3-4-million-after-er-misses-aneurysm/
Posted February 17, 2012 in Medical Malpractice by writer Aaron Kase

It’s gospel in health care– if you have chest pains, get to the emergency room, especially if you have a history of heart problems. But an inexperienced ER doctor in New York thought his patient’s complaints weren’t serious, and sent him home with muscle relaxers. The result was deadly.

A Rockland County jury Wednesday awarded $3.4 million to the family of Michael McKenzie, who was discharged from the Good Samaritan Hospital in Suffern in 2007 after complaining of chest pains and other symptoms consistent with a serious heart problem. The hospital determined that McKenzie, 49, was not having a heart attack, then ER doctor Michael Kane diagnosed him with a muscle strain and sent him home with muscle relaxers.

Two days later, McKenzie was found dead in his house by his 10-year-old son, killed by an aortic aneurysm.

The hospital should have found the aneurysm, argued Anthony DiPietro, the attorney for McKenzie’s family.”They just blew it,” says DiPietro, who headquarters his practice in New York City. “He had textbook signs of an aortic dissection [bleeding into the wall of the main artery that carries blood from the heart]: Chest pain, back pain, shortness of breath, sudden onset, woke him up from sleep, and he wasn’t doing any activities when it happened.”

Compounding the hospital’s error, McKenzie had a history of heart problems that should have pointed them toward the correct diagnosis. In 2003, he had been diagnosed with a dilated aortic root, or enlarged artery, with is a huge red flag for a future rupture. Good Samaritan knew about the dilated root because they had noted it in his chart during a heart procedure McKenzie had undergone the year before his death.

But the doctor, who had been at the hospital less than a month and was working unsupervised, never knew about McKenzie’s history. Why not? Because he didn’t know how to use the hospital’s electronic medical records system.

That's beyond pathetic, but it gets worse.  Far worse:

“He admitted it as part of his deposition,” DiPietro says. “They equivocated. First they said the system wasn’t working [an apparent attempted mistruth - ed.], but then he said he really didn’t know how to use it yet.” According to a local news report, the doctor was certified in obstetrics and gynecology at the time, and didn’t receive his certificate in emergency medicine until the following year.

The hospital argued that the aneurysm wasn’t present when McKenzie visited their ER–despite the fact that his certificate of death stated it had been present for days. The hospital also claimed that McKenzie was responsible for his own death because he didn’t explain his medical history thoroughly enough– the same history that was documented in the hospital’s own records. 

Let me repeat that for emphasis:

The - hospital - also - claimed - that - McKenzie - was - responsible - for - his - own - death - because - he - didn’t - explain - his - medical - history - thoroughly  - enough– the - same - history - that - was-  documented - in - the - hospital’s - own - records.

A hospital dares blame a likely frightened-out-of-his-wits patient presenting to their ED with chest pain, back pain, shortness of breath, of sudden onset that woke him up from sleep, for his own death?   

That, readers, is the most perverse hospital behavior I have ever encountered since entering medicine in 1977 (actually 1972-3 in summer NSF programs at Hahnemann Hospital in Philadelphia).

Not to mention, of course, that said patient cannot defend himself, because he's dead and buried...

In fact, in a highly unusual move, the judge in the case allowed doctors to recount conversations they had with McKenzie to the jury, statements usually prohibited under New York’s “Dead Man’s Statute” designed to keep hearsay out of the courtroom. 

It's a very special hearsay indeed when the hear-sayers know the patient is in his grave and cannot respond.

The tilted playing field notwithstanding, the jury nevertheless found the hospital negligent and awarded $3.4 million to McKenzie’s widow, two adult daughters and now 14-year-old son. The money couldn’t come soon enough– the widow, now sole provider for her son, recently lost her job and their home went into foreclosure. “Hopefully this will allow them to keep the house,” DiPietro says.

The ironically-named hospital planned an appeal:

A Good Samaritan spokesperson said the hospital plans to appeal.

I will attempt to find if the dockets are publicly accessible.

So, to recap, an ED doc didn't know how to use an EHR that contained lifesaving diagnostic information misses an aneurysm, the patient dies, and the defense attempts to blame the patient for his own death for (allegedly) not telling the doctor thoroughly enough about his own medical condition, i.e., the frightened, in-severe-pain patient didn't know medicine but should have - doesn't everyone?

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

I could almost not believe this story, thinking maybe it was exaggerated - until just a few days later I EXPERIENCED THE SAME ISSUE MYSELF, PERSONALLY.

As substitute plaintiff in the death of my mother in 2011 due to a 2010 medication reconciliation failure at Abington Memorial Hospital, as mentioned on this blog and in the press (e.g., Bloomberg News, http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html and Kaiser Health News, http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx), the hospital responded (finally) to the points raised in the Complaint filed in October 2011, after exhausting many procedural delay tactics.

The are attempting to blame my mother, who I took to the ED while she was in process of nearly having a stroke, and me as well for her injuries.

From their Sept. 9, 2013 filing:

... 41. The injuries allegedly sustained by [substitute] Plaintiffs decedent [my dead mother - ed.] were caused in whole or in part or the same may have been contributed to by the actions of the Plaintiffs decedent [my dead mother - ed.], and accordingly, any claim for damages is barred or the damages recoverable herein must be reduced in accordance with the provisions of the Pennsylvania Comparative Negligence Act, as may be applied to facts disclosed in discovery.

They're apparently claiming (quite falsely, as I was there) that my mother, brought to the ED by me with a headache and suffering cerebral ischemia, never advised the doctors and nurses about her heart medication Sotalol (which was in their ED and floor EHR's from prior visits - just as in the aneurysm case above) that they summarily terminated, leading to disaster, so that her injuries and death are her own fault. 

Of course, my mother is dead, so only I can speak for her.

My mother would personally respond to Abington Memorial Hospital's charges blaming her for her injuries under their care and subsequent death, but she is not available to do so, at least in this world.  Rest in Peace, Mom, I have your six.

They also attempt to blame me for my mother's harm and death, a layperson (I have not practiced medicine in over 21 years):

54. Upon information and belief, Scot Silverstein’s actions and/or omissions may have been the cause or one of the causes of the harm suffered by the Decedent and/or her Estate.

55. Upon information and belief Scot Silverstein may be contributorily or comparatively negligent for any harm to the decedent and/or her Estate.

They also falsely claim I never informed medical staff about my mother's heart medication, nothwithstanding their own medication reconciliation (verification) policy calls for a best-effort complete re-verification of medications from all available sources at every transition of care, such as when she went from ED to ICU, and then ICU to floor, when I was not present.  Such resources would include, among others:  1) me, via telephone (not used);  2) the patient (apparently this resource was not used); 3) past EHR visit med lists showing the heart medication (also, apparently not used). 

As the Abington Hospital filing was signed and verified by their VP "Patient Advocate" / Director of Risk Management Regina Sturgis, considering these cases, I must ask the question if the practice of "blaming the harmed or dead patient" for their harm is a risk management strategy taught in the seminars these folks attend.

Blaming dead patients or their families for harm from medical misadventures is absolutely horrifying.  It shows disrespect for the dead and is depraved, especially coming from a hospital, I think any prospective patient would agree.

-- 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

Patients as lab rats for beta software: have sancrosanct patient's rights been trivialized, while poor software of non-trivial risk been sanctified?

I have noted a class action lawsuit vs. Allscripts and Eclipsys, EHR producers, regarding a merger:

UNITED STATES DISTRICT COURT, NORTHERN DISTRICT OF ILLINOIS, EASTERN DIVISION; BRISTOL COUNTY RETIREMENT SYSTEM, Individually and on Behalf of All Others Similarly Situated, Plaintiff, vs. ALLSCRIPTS HEALTHCARE SOLUTIONS, INC., GLEN E. TULLMAN, WILLIAM J. DAVIS AND LEE SHAPIRO, Defendants.

The Lead Plaintiffs' Amended Complaint is available here in PDF:  http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf.  It is worth reading, if just to understand the inner workings of an unregulated healthcare device industry on which your well-being and that of your family increasingly depends.

Lead Plaintiffs' Amended Complaint, available here in PDF:  http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf

The lawsuit is primarily about alleged misrepresentations made to investors by Allscripts and Eclipsys in a merger regarding inability to integrate products, leadership chaos, and materially false and misleading statements and omissions made during the Class period by these companies about their progress.

I note that in a chaotic environment such as alleged, product safety is not likely a big concern.

However, even more ominous are the allegations of deliberate use of beta software on patients without informed consent or any knowledge by patients whatsoever of its use, which apparently did not work out well.  Not indicated is if patient harm occurred.  If the allegations are true, considering the ECRI Deep Dive health IT risk study results of nearly 200 health IT "incidents" in 36 hospitals over 9 weeks voluntarily reported, including 8 harm incidents and 3 possible deaths - see http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html it would not be surprising.

From the Complaint, allegations on software beta testing are as follows.  Emphases mine:

41. CW1 [coded person's name - ed.] explained the different interface integration systems as native integration, disparate integration, and High Level 7 “HL7” interface. The goal of native integration was to have the ability to update patient information throughout the Allscripts’ software offerings. This would allow Allscripts’ Sunrise products to seamlessly integrate with Allscripts’ Enterprise, Professional and MyWay products and allow the products to update patient health records without the use of industry standardized codes. Allscripts branded its native software as ADX. [see Complaint footnote 2.] CW1 described disparate integration as allowing Allscripts software to interface with non-Allscripts software which he described as a Health Information Exchange (“HIE”) software that allowed data to be read and
updated from different software vendors.

42. CW1 said ADX 1.0 was designed to pull and update patient electronic health records automatically and was Allscripts’ native integration software. In approximately July 2011, he learned that Allscripts began a complete reworking of ADX 1.0 because customers were complaining about the lack of functionality and integration, and that it did not allow the user to review and approve changes made in other healthcare settings before being accepted by the hospital or physician practice systems. [If the allegations are true, these problems would be creating on its face significant risk of oversights, confusion and medical errors  - ed.] The upgrade was going to be known as ADX 1.5, but the method and interface for data integration changed. In particular, the interface was changed to allow clinicians to approve changes before they were entered into the system. He also learned from other Allscripts employees that ADX 1.0 was being beta tested [see Complaint footnote 3] at Blessing Hospital in Quincy, Illinois and another place he could not recall, but it was suspended in approximately the middle of 2011 because it failed to perform to expectations. [see Complaint footnote 4] [Remarkable - if the allegations are true, experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations" - and what of the unconsenting meatbags a.k.a. patients it was purportedly tested on? - ed.]

Complaint footnotes:

[2] CW1 described the HL7 interface as using industry standardized codes or language to allow users of disparate software systems to update patients electronic health records.

[3] In software development, “beta testing” generally refers to a testing phase in which a subset of the intended user population tries the product out, in order to see how the product works in real-world conditions.  [What sane patient would consent to such testing of medical IT involved in their care, to 'see how it works in real-world conditions'? - ed.]

[4] See also ¶158 (Defendant Davis’ May 8, 2012 statement “our initial release of our integrated capability...was launched in the middle of last year”); ¶189; cf. ¶76 (CW11’s statement that beta testing at Blessing occurred in late 2011 and was halted in Spring 2012);

Again, I find the allegations of great concern - that experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations."  If true, what of the unconsenting meatbags a.k.a. patients?  They would not have counted for much.

More from the Complaint in Count 50:

50. Consistent with CW2, CW3 said the Helios system was never taken to production while he worked at Allscripts. After he left to join Medicity he had heard that Allscripts delivered a Helios type product for beta testing in the fall of 2011 at the New York Presbyterian Hospitals and it did not go well and that the beta testing of the Helios product at the North Shore Long Island Jewish Community Hospital was scratched prior to implementation.

If the allegations are true, New York Presbyterian Hospitals in the fall of 2011 were performing beta testing of software so bad it was deemed unacceptable for LIJ Community Hospital.  Again, if true, what about the risks patients were subjected to, and ... were any harmed?

Still more in Count 76:

76. CW11 said that Blessing Hospital in Quincy, Illinois was beta testing ADX 1.0 sometime in late 2011, but could not recall specifically when it began. CW11 said he was told that the testing was stopped in early 2012 because the product was not working properly and Allscripts deployed a product development team to Blessing Hospital to develop a workflow which lead to ADX 1.5. As far as CW11 knew, no one went live on ADX 1.0. Blessing Hospital began testing ADX 1.5 in late Spring 2012, and was the first to go live using ADX 1.5 in July 2012 which allowed the integration of patient information seamlessly between Sunrise and Enterprise applications. Components of Helios went into ADX 1.5. ADX 1.5 allowed for integration of patient data relating to PAMI (problems, allergies, medications, and immunizations) but some competitor products allow for significantly more types of data to be seamlessly exchanged and Allscripts was working to increase the types of data that could be seamlessly exchanged between acute care and ambulatory applications.

In effect, if the allegations are true, sancrosanct patient's rights have been trivialized, while poor software of non-trivial risk has been sanctified.

This would be, needless to say, deranged.  Software can be debugged in test environments without putting patients at risk - if one is willing to invest the resources to do so.

The Class Action lawsuit Plaintiffs should perhaps seek to discover if there were patient harms or deaths as a result of the alleged software beta testing - assuming that information was not thoroughly "cleansed" by now.

I also note that even small NIH SBIR/STTR grant proposals involving use of new or modified IT on patients, on whose study sections I am an invited reviewer in the domain of Medical Informatics, are subject to human subjects protection evaluation:

http://grants.nih.gov/grants/peer/critiques/sbir-sttr.htm

... Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46 [see http://www.research.uci.edu/ora/forms/hrpp/categories_of_exempt_human_subjects_research.pdf - ed.], the [grant review] committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

In health IT tests in hospital settings, which is most certainly experimentation, there are simply no human subjects protections whatsoever.  Hospital IT deserves no special accommodation regarding Protections for Human Subjects.  There are no justifiable reasons I can think of. 

-- SS

Addendum:  Perhaps I'm wrong about people's generosity and altruism.  I would like to hear from people who would gladly submit, say, their newborns as test subjects for the beta testing of experimental health IT software.