New ONC Director Karen De Salvo seems no better than her predecessors - risk, harms and deaths due to health IT apparently OK for now, and all we need is a "Safety Center"

Karen De Salvo has assumed the role of Director of ONC, the office of the National Coordinator for Health IT at HHS (http://www.healthit.gov/newsroom/dr-karen-desalvo-md).

A pretty face, but here's evidence of the same old tired political hucksterism and spin concerning healthcare information technology. 

In response to perhaps the most candid exposé in the public media to date of the risks and defects of current commercial health IT, industry conflicts of interest, and injuries and deaths, that appeared on July 20, 2014 in the Boston Globe under the title "Hazards tied to medical records rush" (http://tinyurl.com/lm7x34h) by the Globe's Washington bureau chief Christopher Rowland, Ms. De Salvo authored a letter to the editor.

DeSalvo is new to the job, but not to the political message of unbridled health IT hyper-enthusiasm and pointless "Safety Centers", instead of formal regulation as in other mission critical industries using IT (including pharma, for one).

Her letter to the Boston Globe attempts to put lipstick on a pig regarding a technology largely reviled by physicians and nurses due to its poor user experience and defects (rampant due to the free-for-all of this healthcare sector's unprecedented regulatory accommodation, that is, no regulation) that cause patient endangerment.  See http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html, http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html and http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html as just a few examples.

What politicians do:  they spin like neutron stars

Her letter, with my comments:

http://www.bostonglobe.com/opinion/editorials/2014/07/26/many-health-success-stories-note/MyyGM3uq2LU0GqGLLqYJ7M/story.html

Letters | CHALLENGES IN THE MOVE TO ELECTRONIC MEDICAL RECORDS

July 27, 2014

Many health-IT success stories to note

I was disappointed to read “Risks, some dire, tied to medical records rush” (Page A1, July 20), as it failed to mention any examples of patients and their health care providers benefiting from the use of health information technology, including electronic health records. 

As to "disappointment", nearly the entire healthcare and lay press is filled with "success stories" and other propaganda.  There is, in fact, no need for artificial and industry-favoring "balance" in the rare article about the downsides. The industry has its own very large mouthpiece.  (This is the response we at HC Renewal give to critique that we're not "balanced" in every post.  It would be as if every article on defective avionics and pilot training issues that cause hundreds to die (e.g, Air France Flight 447, http://en.wikipedia.org/wiki/Air_France_Flight_447) should be accompanied by articles on just how many non-fatal flights there are, too; or as if every article about criminals has to mention there are good people, too.)

Such success stories are playing out across the country daily, including in Boston, and their omission from the article incompletely portrays the important role of electronic health records in improving patient safety and outcomes.

Is this and example of a far-left "you have to break an egg to make an omelette" (even if the 'egg' is a human being) thinking?   This statement, attempting redirection from the downsides, in effect says: "It's OK to sacrifice 100 in experimentation to (potentially) 'save' 10,000 - or 1,000 to 'save' 100,000."

Problem is, this is not how Western medicine is supposed to work - by HHS's own policies on research ethics, and international agreements and treaties based on work that arose after WW2's medical abuses, no less, e.g., the Nuremberg laws.

In medicine, legal and ethical standards such as the NIH Guidelines for Conduct of Research Involving Human Subjects (http://grants.nih.gov/grants/policy/hs/regulations.htm), the World Medical Association Declaration Of Helsinki (http://www.wma.net/en/30publications/10policies/b3/) and others restrict introduction of new drugs and medical devices without informed consent, and without extensive preclinical and clinical testing and post-marketing surveillance, especially when risks of the technology are unknown.  

And health IT is decidedly experimental, considering we don't even know the true extent of harms, by multiple admissions (by FDA, IOM, ECRI etc., see http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

Also see my post Mar. 12, 2012 post "Human Subjects Experimentation Directives Ignored in the Grand Health IT Experiment?" at http://hcrenewal.blogspot.com/2012/03/human-subjects-experimentation.html.  The highlights, emphases mine:

Directives for Human Experimentation
NUREMBERG CODE

1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice [that is, to opt-out - ed.], without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person [information on HIT risk exists, such as on this blog - ed.] which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
2. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
3. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
4. During the course of the experiment the human subject should be at liberty to bring the experiment to an end [go back to paper - ed.] if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
5. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage [go back to paper - ed.], if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Perhaps they don't teach these things at Harvard?

Back to De Salvo's letter:

A fully electronic health system can help identify and prevent potential medical errors. The Office of the National Coordinator for Health IT has taken steps to address the safe use and implementation of electronic health records, including sponsoring the Institute of Medicine report referenced in the story.

And since that 2012 report, which acknowledges that bad health IT causes risks, errors and harms to a definite but unknown magnitude (see bottom section of my post at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html), ONC has done next to nothing. People are exposed to risk, harms and deaths and that seems just fine to ONC, for if it were not, they would have acted aggressively - say, as if a type of jet plane, or nuclear power plant had been revealed to pose risks and dangers to the community.

As Mr. Rowland himself pointed out in the Boston Globe article:

... In 2011, the Institute of Medicine said the lack of a central repository for reporting error-prone software, patient injuries, and deaths, combined with nondiclosure and confidentiality clauses in vendor contracts, “pose unacceptable risks to safety.”

It strongly recommended that the Obama administration mandate that vendors report “deaths, serious injuries, and unsafe conditions” to a centralized, government-designated entity. Such reports should be made available to the public, it said, without information that would identify individual patients and providers.

Three years later, no such reporting system exists.

Instead, ONC takes the GM ignition switch approach (http://en.wikipedia.org/wiki/2014_General_Motors_recall):

... On February 7, 2014, GM recalled about 800,000 of its small cars due to faulty ignition switches, which could shut off the engine during driving and thereby prevent the airbags from inflating ... GM says it expects to charge $1.2 billion against its second quarter earnings as a result of its ongoing recalls, and the charge could get worse as lawsuits and investigations continue. 

The fault had been known to GM for at least a decade prior to the recall being declared.  Some have suggested that the company actually approved the switches in 2002 even though they knew they might not meet safety standards.

The company is facing multiple investigations into why it did not attempt to fix these faulty ignitions sooner, including a federal criminal probe, as well as a probe led by Anton Valukas, the latter of which produced a report which GM made public on June 5, 2014.

Instead of a serious approach to safety, ONC and De Salvo champion window dressing:

Most recently, the Office of the National Coordinator, the Food and Drug Administration, and the Federal Communications Commission issued a proposed plan that would include the creation of a health IT safety center, which would assist in the voluntary reporting of health IT-related medical errors. Many patient advocates, medical professionals, and other stakeholders have expressed support for this approach.

"Many?" - The consensus views, often dominated by industry insiders and others with conflicts of interest, is how ONC and De Salvo apparently think safeguarding the public is to be done.  Those who veer from this "consensus" with facts of risk and harms are to be ignored.

As to the hypocrisy and absurdity of a toothless "health IT safety center", see my April 9, 2014 post "FDA on health IT risk: reckless, or another GM-like political coverup?" at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.

The hundreds of thousands of providers successfully and safely using electronic health records today show that health IT can, and does, improve health and health care.

Dr. Karen DeSalvo
National coordinator for health information technology
Department of Health and Human Services
Washington

Ms. De Salvo apparently never got this Mar. 14, 2014 CMS memo that was sent in response to a query by the American Association  of Physicians and Surgeons:

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.

However, in politics, such issues do not seem to matter as compared to passing along the party line. 

In medicine, they do matter.  Very much so (see http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html).

-- SS

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

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

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

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

June 01, 2014  •  By Emily Bregel, Stephanie Innes

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

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

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

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

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

• Pharmacy Medication Mapping Errors

• Microbiology Results Mapping Incorrectly 

• Prescription printing bugs

• Errors transmitting prescriptions

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Try doing medicine on an iPhone screen area...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

-- SS

Athens Regional Medical Center: Hospital management is "addressing computer problems" AFTER patients are put at bodily risk, not before, only in response to irate clinicians; then claiming everything will be fixed soon while doctors resign.

(Note: also see my June 16, 2014 followup post at http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html)

Maybe hospital management gurus could address these computer problems BEFORE turning them loose on patients?

Physicians in Georgia seem to have more guts than their colleagues elsewhere.  Rather than letting patients be guinea pigs for the naive fantasies of hospital executives about health IT, these physicians said "get these [expletive] computer systems out of our hospital"...

Then they started resigning their appointments:

Athens Regional addressing new computer system problems encountered by doctors

By Donnie Z. Fetter
Friday, May 23, 2014

http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors

Doctors affiliated with Athens Regional Medical Center (http://www.athenshealth.org/) have expressed concerns that a computer system installed this month at the hospital endangers patients.

Not "may endanger patients."  "Endangers patients."  That's quite direct.

However, the hospital's chief executive said Athens Regional is taking "swift action" to address those concerns.

I'm not impressed.  The executives should perhaps have done due diligence and taken action BEFORE this bad health IT was set loose on live, unsuspecting patients.

It's not as if the issues are unknown (as Google or anyone who actually knows what they're doing regarding health IT will easily demonstrate).  Further, those executives have the legal obligation to maintain a safe healthcare environment.

In a letter dated May 15 and provided to the Athens Banner-Herald this week, multiple doctors noted such concerns as “medication errors ... orders being lost or overlooked ... (emergency department) patients leaving after long waits; and of an inpatient who wasn’t seen by a physician for (five) days.”

Any of these issues and the multitude more I can predict exist can lead to severe injury or death, especially in fragile patients and the elderly.  Trust me, I know both professionally and personally...
 

The letter was addressed to ARMC President and CEO James G. Thaw and Senior Vice President and CIO Gretchen Tegethoff. It was signed by more than a dozen physicians, including Carolann Eisenhart, president of the medical staff; Joseph T. Johnson, vice president of the medical staff; David M. Sailers, surgery department chair; and, Robert D. Sinyard, medicine department chair.

The doctor who provided the letter to the Banner-Herald refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues.

Refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues ... due to fear the executives would then return the doctor's concerns with genuine love and appreciation, and give him or her a generous promotion and pat on the back, no doubt.  (Actually, quite likely was a fear of retaliation, e.g. sham peer review as at http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians.)

Note the educational background of CIO Gretchen Tegerhoff, the executive with fiduciary obligations to implement health IT of the highest quality and to have robustly researched all of the issues involved (and whom the Board should have thoroughly vetted as to required background for health IT leadership):

University of Georgia
Terry College of Business, Executive Program, Finance
2014 – 2014 (expected)

The George Washington University - School of Business
Master of Science, Information Systems Technology
2001 – 2003

West Virginia University
BS, Medical Technology
1993 – 1997

Note the career progression that is the envy of, say, someone who's completed the rigors of medical training (premed, medical school, internship/residency, clinical postdocs) and beyond that, completed an additional PhD, MS or post-doctoral fellowship in Medical Informatics at unknown universities such as Harvard, Yale, Stanford, Johns Hopkins, Columbia, etc. (reverse chrono):

Technical Analyst
STG (9 months)
[Provided U.S. Department of State with systems support and application maintenance.]

Clinical Systems Analyst
George Washington University Hospital (3 years 8 months)

Technical Support Specialist/Installer
Intellidata, Inc. (9 months)

Clinical Research Associate
QUINTILES, INC. (9 months)

Information Specialist
THE EMMES CORPORATION (1 year 8 months)

Writer/Editor
ASPEN SYSTEMS CORPORATION (7 months)

Medical Technologist
PROVIDENCE LABORATORY ASSOCIATES (8 months)

This background led directly to:

Chief Information Officer
George Washington University Hospital (6 years 8 months)

and then the current role:

Athens Regional Health System
Vice President and Chief Information Officer
Athens Regional Health System

If you believed that the qualifications required for medical practice - let alone medical leadership roles - is at least an order of magnitude more robust, you'd not be mistaken.

Perhaps even worse, business-IT amateur meddlers in clinical affairs sell the "best practices" that lead to debacles like this, and perhaps to IT-related patient injury and death, via their alphabet-soup "leadership" organizations.  This CIO also holds this credential:

Faculty

CHIME Healthcare CIO Boot Camp (8 months)

It should be noted, and scandalously so considering the negligence that leads to patient endangerment and this kind of physician revolt from the outset, that IT-related patient harms are not uncommon.  For example, per the Harvard community's med mal insurer CRICO, see "Malpractice Claims Analysis Confirms Risks in EHRs" at
http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html, the ECRI Institute, see "ECRI Deep Dive Study of Health IT harms" at
http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html as well as "ECRI Institute's 2014 Top 10 Patient Safety Concerns for Healthcare Organizations" at
http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html, "FDA Internal Memo on H-IT risks - for internal use only" (uncovered by investigative reporter Fred Schulte) at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html, and others as posted at this blog.

“From the moment our physician leadership expressed concern about the Cerner I.T. conversion process on May 15, we took swift action and significant progress has been made toward resolving the issues raised,” Thaw wrote Thursday in an email. “Providing outstanding patient care is first and foremost in our minds at Athens Regional, and we have dedicated staff throughout the hospital to make sure the system is functioning as smoothly as possible through this transition."

This raises several questions:

• How about the moments from the time of decision to acquire the technology?  What safety consideration were in effect during that time? 

• What if the "significant progress" is insufficient to prevent a patient from being maimed or killed due to toxic effects of bad health IT?  Who's responsible? 

• Perhaps most importantly from the human rights perspective - are patients being provided informed consent about these "issues raised" and are they afforded the opportunity to seek care elsewhere until the "swift progress" is completed?  

One wonders if the executives were aware of analytic work on Cerner ED systems such as performed by U. Sydney professor Jon Patrick at "A study of an Enterprise Health information System",  http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146; or this site on health IT difficulties:  http://cci.drexel.edu/faculty/ssilverstein/cases/, or this blog and others.

It's not as if a simple Google search won't find them, such as https://www.google.com/search?q=healthcare+IT+failure.  Perhaps they need to read more...or hire experts BEFORE go-live.

Back to the article:

The intended goal of the system designed by health care information technology company Cerner is to improve efficiency and connectivity by providing doctors, nurses and other medical professionals with a shared data set and to eventually allow patients online access to their medical records, Athens Regional executives previously said.

Good intentions or not, badly designed and/or implemented technology harms or kills, and those harmed, or the dead, really don't care what the system is 'intended to do.'  Patients are not guinea pigs towards an IT company's or hospital's experiments with computers - regarding which the executives are usually in to at a level way over their collective heads.

But doctors noted the new system often proved too cumbersome to be effective at the time the letter was written.

“The Cerner implementation has driven some physicians to drop their active staff privileges at ARMC,” noted the letter. “This has placed an additional burden on the hospitalists, who are already overwhelmed.

That's just horrendous for safety.

Joint Commission, where are you?
 

Other physicians are directing their patients to St. Mary’s (hospital) for outpatient studies, (emergency room) care, admissions and surgical procedures. ... Efforts to rebuild the relationships with patients and physicians (needs) to begin immediately.”

Doctors voted with their feet.  Bravo.

I suggest they consider the following remedies as well if appropriate, from my post at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html:

... When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)

• Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "disruptive physician" and/or or being subjected to sham peer review (link).

• Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)

• Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at http://www.jointcommission.org/report_a_complaint.aspx . Also consider writing the JC senior officers (link to officer's list), whose awareness of HIT issues I can personally attest to via our correspondences.

• Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. An example of such an adverse event report I filed myself (when the involved hospital refused) is at this link in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.

• Inform the State Medical Society and local Medical Society of your locale.

• Inform the appropriate Board of Health for your locale.

• If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "Quality Insights of PA."

• Inform a personal attorney.

• Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.

• As clinicians are often forced to use health IT, at their own risk even when "certified" (link), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:

"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]

We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice.

With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at http://www.jointcommission.org/assets/1/18/SEA_42.PDF, the IOM report on HIT safety at http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, and the FDA Internal Memorandum on H-IT Safety Issues at http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology.

CMO __________ (date, time)
CIO ___________ (date, time)
CMIO _________ (date, time)
General Counsel ___________ (date, time)
etc."

• If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.

• As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.

These measures can help "light a fire" under the decision makers, and "get the lead out" of efforts to improve this technology to the point where it is usable, efficacious and safe.

More from the article:

Doctors called the time line to install the EHR system too “aggressive” and said there was a “lack of readiness” among the intended users.

For financial incentive reasons in part, I'm sure.  Computers, after all, seem to have more rights than patients...or than physicians and nurses.

Since receiving the letter, Thaw said Athens Regional has added "specialized staff" to meet daily with physicians to discuss computer system and safety issues.

Again, the key word is "AFTER."   A good move, considering the hospital will be up to its head in defections, accreditation inspections and hearings, and possible medical malpractice and corporate liability lawsuits otherwise.

"Regardless of what system we are using, our focus on patient safety is unwavering, and we will never put a system ahead of doing what is right for our patients," Thaw said. "Our team is working around the clock to resolve any remaining issues, and we remain dedicated to delivering outstanding patient care every step of the way."

Feel-good executive boilerplate and an outright lie on its face.  If the focus on safety was unwavering, this problems would not now need emergency remediation.  As I had written many years ago here: http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story, this type of shallow executive puffery and rhetoric only makes clinicians angrier.

And while events like this go on, the industry pundits suggest all that's needed is a Health IT 'Safety Center' instead of regulation like the rest of the healthcare industry ("Feds Call For Health IT Safety Center", May 20, 2014, http://www.govhealthit.com/news/feds-call-hit-safety-center?topic=,26#.U4FVDnYsC).  This is sort of like putting the safety of our country's hospitals in the hands of Consumer Reports.

That's not exactly the ticket to a rapid cure to these problems, which are more common than most physicians have the bravery (or career options in the face of retaliation) to admit.

At least nurses' unions are taking action, as at http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html and http://hcrenewal.blogspot.com/2014/05/a-nurses-union-national-nurses-united.html.

Additional thought:  at least the writer of the article did not use the customary euphemism for problems with patient-endangering bad health IT, specifically: "glitches" (http://hcrenewal.blogspot.com/search/label/glitch).

-- SS

May 27, 2014 Addendum:

The CEO has apparently resigned, see http://onlineathens.com/local-news/2014-05-23/thaw-resigns-athens-regional-ceo. 

I also solicit physicians from the area of this hospital to contact me regarding any patient harms that did occur as a result of this debacle, via my email address located here: https://www.blogger.com/profile/03994321680366572701.  I will forward any reports through appropriate legal channels to attorneys who can take action, which in 2014 is probably the only language this industry will actually listen to.

-- SS

May 27, 2014 Addendum 2:

The reader comments at http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors are interesting, and distressing.

-- SS

May 29, 2014 Addendum:

More here:  http://flagpole.com/news/in-the-loop/james-thaw-out-as-armc-ceo

If I were that's hospital's new leadership, I'd immediately go back to whatever system (whether paper or not) was in place before this implementation, and take the time to implement new health IT properly, safely and carefully.

For at this point, if patient injury or death occurs as a result of a system flaw (whether in design or implementation), I believe charges of criminal negligence against the organization and its leaders would be justified.

The following is an example of one state's statute defining criminal negligence:

''A person acts with 'criminal negligence' with respect to a result or to a circumstance described by a statute defining an offense when he fails to perceive a substantial and unjustifiable risk that such result will occur or that such circumstance exists. The risk must be of such nature and degree that the failure to perceive it constitutes a gross deviation from the standard of care that a reasonable person would observe in the situation.''

I believe other states' statutes are similar.

-- SS

June 13, 2013 Addendum:

My post on Athens Regional Medical Center's physician revolt was accessed today by someone at Cerner; note the referring link:  http://cerner.vertabase.com/project/document/index.cfm?&0.12455576848

Vertabase (http://www.vertabase.com/) makes project management software.

Cerner.vertabase.com/project/document is some sort of password-protected document resource.

I find that interesting - perhaps it's for internal communications and they are learning something from me.

Domain Name		(Unknown)
IP Address		159.140.254.# (Cerner Corporation)
ISP		Cerner Corporation
Location		Continent  :  North America Country  :  United States  (Facts) State  :  Kansas City  :  Kansas City Lat/Long  :  39.1111, -94.6904 (Map)
Language		English (U.S.) en-us
Operating System		Macintosh MacOSX
Browser		Safari 1.3 Mozilla/5.0 (Macintosh; Intel Mac OS X 10_8_5) AppleWebKit/536.30.1 (KHTML, like Gecko) Version/6.0.5 Safari/536.30.1
Javascript		version 1.5
Monitor		Resolution  :  1440 x 900 Color Depth  :  24 bits
Time of Visit		Jun 13 2014 11:47:42 am
Last Page View		Jun 13 2014 11:47:42 am
Visit Length		0 seconds
Page Views		1
Referring URL		http://cerner.vertabase.com/project/document/index.cfm?&0.12455576848
Visit Entry Page		http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html
Visit Exit Page		http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html
Out Click
Time Zone		UTC-6:00
Visitor's Time		Jun 13 2014 10:47:42 am
Visit Number		1,342,222

 -- SS

Note: also see my June 16, 2014 followup post at http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html

A Nurse's Union, National Nurses United, Takes On Bad Health IT

National Nurses United (http://www.nationalnursesunited.org/), a nurse's union, takes on bad health IT with both satire and seriousness:

Hey dude!  I'm your highly-cost effective computer technician Steve.  Tell me what's hurtin' and I'll program it into Frank, our computerized doctor and nurse replacement. (YouTube video at https://www.youtube.com/watch?feature=player_embedded&v=YthF86QDOXY.)

See their page at http://www.nationalnursesunited.org/site/entry/insist-on-an-rn

I note that nature abhors a vacuum, and since medicine's watchdogs (e.g., FDA), physicians and their organizations, the Medical Informatics community and others who know better have left a deep vacuum over health IT problems, I'm glad unionized nurses have stepped up to the plate.

-- SS

EHR Story for Mother's Day 2014: Even The Formerly Simple Act Of Giving IV Fluids in ICU's Can Kill Babies. But's Let's Be Objective and Happy!

[Note to the humorless:  this post is satirical and sardonic to make a very serious point about the perversity of downplaying/ignoring health IT risks, issues too often ignored by those who know better.  If you don't like satire, don't read it.]

I've been critiqued for posting in too gloomy a manner for some's taste, even those who like me are in the Medical Informatics field.  For example, in the Feb. 2013 Kaiser Health News article "Health Technology’s ‘Essential Critic’ Warns Of Medical Mistakes" at http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx:

... Many say he comes on too strong. Even admirers cringed when he began blogging about the 2011 death of his mother, which he blames in a lawsuit on a computer error that allegedly caused Abington Memorial Hospital to overlook a key medication. (Both he and the hospital said they couldn’t comment on a pending suit.) Personalizing his campaign, some thought, made him seem less objective.

Of course, if a close relative of these unnamed "many" were killed by, say, a drunk driver (something this unobjective group of mothers takes seriously:  http://www.madd.org/), or if their child were abducted and decapitated (http://en.wikipedia.org/wiki/Murder_of_Adam_Walsh), or if something like this event (https://www.youtube.com/watch?v=55XJivhjB4U) happened, their response would surely be "oh well, stuff happens, let's all be 'objective', not 'personalize' things, not advocate with our personal stories, and above all, be happy!   

 

I really do admire the unnamed "many" for their ability to detach, so am presenting the following story of "anecdotal" patient harm to a child in a pediatric ICU in the spirit of happiness, joy, and Mother's Day love!

Here's the event we should all be happy about, reported via FDA - I note the FDA's said these devices are not "sufficiently risky" to warrant a high level of their attention even though they secretly admitted in an internal memo that there's no way to really know te true level of risk and harm (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html), so clearly they're all a really jolly bunch:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=117690

FDA MedSun report

Type of device: medical device data system
Device brand name: PowerChart
Device manufacturer's name: Cerner Corporation
Date of this report: (mm/dd/yyyy) 03/04/2014

Describe the event or problem:    

Medication Error. This event was related to Health Information Technology. Specifically, the manner in which the system processed an order for free water replacement. Order was intended to be 20ml/hr for 6 hours for a total of 120ml. It was a 1000 ml bag so first they put 20ml/hr which would have defaulted the infuse over time to 50 hrs. They tried to change the infuse over to 6 hours which then changes the ml/hr rate to 167 ml/hr. They did not notice this had changed. 

Well, that's WONDERFUL!!  :-)  that the computer recalculates the flow rate for them when they change the infusion time, by paternalistically assuming that's what they wanted to do - change the RATE of infusion - when what they actually did is manually change the TIME (duration) of infusion. 

How LOVELY of some programmer to have given them this FANTASTIC convenience!!

Aren't computers wonderful!!!

Even the following should not be cause for ardent technophiles to wipe the smile from their downside-ignoring faces!!

... They did not realize that they needed to go into details tab to show the time frame so the patient got 167ml/hr instead of 20ml/hr for 6 hours. 

How obvious!!!  Every doctor, nurse, medical student and janitor knows from time immemorial knows you have to go into the detail tab to show the time frame!  (Smile)

... Order was verified by pharmacy and administered at that rate via peripheral IV. After approximately 1L of fluid had infused, patient showed seizure activity.  PICU (pediatric ICU) team called to bedside. Treatment provided for seizures and critical sodium and potassium. 

Awww ...  some seizures and critical sodium and potassium levels in the PICU.  Awww.....too bad!!!  We should be happy anyway!  For if this child died...the sacrifice would have been WORTH IT for the betterment of electronic medical records worldwide, and the parents no doubt would be flattered and joyous about their contribution to computing science.  After all, how better to figure out how to make this technology work??

After all, it takes a few broken eggs to make an omelette, and a few bumps in the road (like grave mounds) should be of little concern.

Because, remember ... w.e. c.a.r.e!

i c.a.r.e!!!!  As at U. Arizona Healthcare System, let's only use Happy Words with our patients about these systems! (click to enlarge, see http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html )

Further, we should use only Words That Work to describe the wonders of these systems in their current state!!!

Some flowers from Cerner CEO Patterson to momma to make up for her little baby having seizures and critically deranged potassium and sodium levels from those big, bad doctors' EHR mistake!

... The Cerner powerchart software system has functionality for continuous medications/fluid ordering that does not prevent "user error." 

Ut oh ... Looks like I'm going to have to be a sourpuss for just a moment and re-introduce the nasty, ill-tempered, non-objective idea of what the dastardly National Institute of Technology and Standards (NIST) calls "use error" (as opposed to "user error", A.K.A. "Blame the User",  http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html):

... The EUP (EHR usability protocol) emphasis should be on ensuring that necessary and sufficient usability validation and remediation has been conducted so that use error [3] is minimized.

[3] “Use error” is a term used very specifically to refer to user interface designs that will engender users to make errors of commission or omission. It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging [or lack of messaging, e.g., no warnings of potentially dangerous actions - ed.], misuse of color-coding conventions [see below], omission of information, etc.

Awwwwww....aren't I just mean and non-objective?

That mean doctor Silverstein's just not happy and objective!!  Bad, bad, bad man!

... When the provider orders the fluid, example is D5W, the screen opens to a "continuous details" ordering window. Within the screen, the ordering provider is presented with a preselected bag volume and type of fluid with a brownish background. They have the ability to modify bag volume but it was made this color to discourage that change by Cerner. 

Golly gee!  There's something to be happy about once again!  Brown, the universally-understood color, in any language, means "Warning, do not change this value, it could kill someone!!!" See how GOOD this technology really is!!!  Why use alerts and confirmation dialogs when a mere COLOR like brown suffices!!

... The rate and "infuse over" fields are a yellow color to show that they need to be completed. The intent [of the programmer, clearly an expert in human-computer interaction and communication by color and smoke signals - ed.] is for an ongoing continuous fluid and not to limit the time. 

Golly Gee Times Two!  Yellow, the absolutely universal color for "Warning, you need to complete this to prevent killing someone!"  

Yellow!  Don't you just think every time you see this color that "warning, you need to complete data entry to avoid killing someone?  Who needs WORDS?

It's all so CLEAR!!!!

... Providers can misinterpret this field to mean the length of time they want the order to infuse over, when the system intent for that field is to be the system-calculated length of time until the next bag supply will need to be sent to maintain the continuous infusion. 

See how simple!!!!   Isn't it OBVIOUS!!!!

The completed fields turn white. Cerner does not have an intermittent fluid administration order [who the hell needs that, says Cerner and the hospital executives who bought this package for the PICU!! Never a need for that in ICU's!! - ed] so providers are expected to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, they may inadvertently order a higher rate than intended.

Ha ha!  Those silly doctors can't even figure out a simple thing like that!!  What stooges they are!!

NYUK NYUK NYUK ... Hey Moe!!  Those silly doctors and nurses cannot understand the simple fact that Cerner does not have an intermittent fluid administration order so providers are expected to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, they may inadvertently order a higher rate than intended. 

See how much FUN health IT problems can be?  After all, in this ANECDOTAL case, all that happened was:

The device(s) may have caused or contributed to: Potential for patient harm, Serious Injury

But nobody died of this particular problem (that we know of), so this technology is SAFE!!!!

Happy mother's day!!!

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

Additional not-so-funny thought:  depending on brown, yellow etc. instead of clear, written alerts/warnings, plus the fact that the system likely "knew" the weight of the child and should have alerted that the infusion of a liter was a very dangerous thing, reflect Bad Health IT on its face:

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.  

Had I been a pre-marketing tester of this system working for FDA, those fluid-ordering characteristics would have been changed before the system would have been released to market.

Oh, wait ... there is no premarketing testing process for health IT, and FDA, via advice from the FDASIA committees as in the linked FDA-related post above, writes that none is really needed.

And who wants to damage TRUE INNOVATIONS like this - turning something that takes 5 seconds for a clinician to write, "D5W, 20 ml/hr x 6 hrs" (meaning dextrose 5% in water, 20 milliliters per hour for 6 hours) into a cryptic and muddled exercise with tabs, colors and numerous caveats - via regulation?

-- SS

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