Showing posts with label healthcare IT risk. Show all posts
Showing posts with label healthcare IT risk. Show all posts

Thursday, 23 June 2016

Reckless indifference to nurse's concerns about bad health IT results in showing her the door?

Reckless indifference to nurse's concerns about bad health IT results in showing her the door?

At numerous past posts I referred to hospital executives' reckless indifference to the concern of seasoned clinicians about bad health IT, such as at  http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html and  http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html and other posts.

I now see a stunning story of the results of EHR iconoclasty and patient advocacy:

CNO claims hospital forced her out after she raised concerns about EMR
Becker's Hospital Review
Written by Akanksha Jayanthi  
June 14, 2016 
http://www.beckershospitalreview.com/legal-regulatory-issues/cno-claims-hospital-forced-her-out-after-she-raised-concerns-about-emr.html

 A former nursing executive at Sonoma West Medical Center in Sebastopol, Calif., has filed a lawsuit against the hospital, alleging she was fired after raising concerns the EMR was a threat to patient safety, reports The Press Democrat.

Autumn AndRa, RN, was serving as CNO of the hospital when she approached CEO Ray Hino and said the EMR, called Harmoni, was unsafe, according to the report.

Ms. AndRa was reportedly terminated from her CNO position April 14 and was offered a position in the intensive care unit, which her attorney Daniel Bartley told The Press Democrat would have been a demotion. Ms. AndRa left the hospital due to alleged harassment, according to Mr. Bartley.

If these allegations are true, a clinician, the Chief Nursing Officer, was shown the door in an act of recklessness for her complaining about bad health IT.

Some definitions: 

Bad health IT:

Bad Health IT 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, lacks evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.   

Reckless indifference:

Deliberate indifference is the conscious or reckless disregard of the consequences of one's acts or omissions. It entails something more than negligence, but is satisfied by something less than acts or omissions for the very purpose of causing harm or with knowledge that harm will result.

A wrongful termination lawsuit was apparently filed:

... The lawsuit alleges the EMR system mixes patients' records, so information in one patient's chart moves to another patient's chart. It also alleges the EMR has issues tracking and updating patient medications and does not display patient code status information, which informs providers of patients' desired medical interventions, according to the report.

These types of gross defects, if true, represent an on its face menace to patient safety.

Further, these issues (and the harm that may result) are well known.  In fact ONC's contractor RIT just released a comprehensive review article on health IT problems (see "Report of the Evidence on Health IT Safety and Interventions", May 2016, at https://www.healthit.gov/sites/default/files/task_8_1_final_508.pdf).

CEO Ray Hino had the usual refrain seen in so many postings here (under the blog query "Patient care has not been compromised" - http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised):

Mr. Hino told The Press Democrat the EMR did not pose any danger to patients, and no patients have been harmed because of software defects.

Like most others uttering that line, as I've documented, Mr. Hino apparently lacks expertise (e.g., in clinical, IT or Medical Informatics domains) to render such a judgment about patient danger if the EHR did or does exhibit such problems.  His bio is at https://www.linkedin.com/in/raymondhino.

As to whether patients were harmed, that is irrelevant if the EHR has such defects.  Sooner or later, they will be.  The issue is risk, not body counts (yet).

There's also this.  The EHR in question is not the product of the major EHR vendors but the work of apparent insider.  See http://about.harmonimd.com/usa/ referencing just two implementations, one at Somona West Medical Center, California, the subject of this post, and one at the Kilimanjaro Christian Medical Centre, Tanzania, Africa:

... The lawsuit also names Dan Smith, the developer of the EMR software in question, as a defendant. According to the lawsuit, Mr. Smith "has engaged in retaliation against [Ms. AndRa] and other employees who have voiced concerns that Mr. Smith's electronic medical records system, his self-dealing, and his management of medical and financial decisions are not in the best interests of SWMC and pose life-threatening risks to patient care," reports The Press Democrat.

Not only did Mr. Smith develop the software in question, but he is a significant financial backer and influencer at SWMC. According to a 2015 report from The Press Democrat, Mr. Smith and his wife have contributed nearly $9 million to the hospital in donations and forgivable loans, and he plays a role in "ever major decision" regarding the hospital. Mr. Smith is on SWMC's board of directors. 

I really don't think injured or dead patients (or juries) will find those relationships an excuse for bad health IT, what seems like a clinical trial of new IT by a private company and owner without informed consent (including divulging to patients and users a possible COI), and the discharge of someone complaining about it.

Mr. Smith and hospital officials declined to comment on the lawsuit, citing pending litigation, according to the report.

My expertise is available should the parties so desire.

-- SS

6/21/2016 Addendum:
https://en.wikipedia.org/wiki/Human_subject_research 

Human subjects

The United States Department of Health and Human Services (HHS) defines a human research subject as a living individual about whom a research investigator (whether a professional or a student) obtains data through 1) intervention or interaction with the individual, or 2) identifiable private information (32 C.F.R. 219.102(f)). (Lim, 1990)[2]

As defined by HHS regulations:

"Intervention"- physical procedures by which data is gathered and the manipulation of the subject and/or their environment for research purposes [45 C.F.R. 46.102(f)][2]

"Interaction"- communication or interpersonal contact between investigator and subject [45 C.F.R. 46.102(f)])[2]

"Private Information"- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public [45 C.F.R. 46.102(f)] )][2]

"Identifiable information"- specific information that can be used to identify an individual[2]

Human subject rights

In 2010, the National Institute of Justice in the United States published recommended rights of human subjects:
  • Voluntary, informed consent
  • Respect for persons: treated as autonomous agents
  • The right to end participation in research at any time[3]
  • Right to safeguard integrity[3]
  • Benefits should outweigh cost
  • Protection from physical, mental and emotional harm
  • Access to information regarding research[3]
  • Protection of privacy and well-being[4]

-- SS
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Tuesday, 7 June 2016

NY Times/Steve Lohr asks "Why the Economic Payoff From Technology Is So Elusive."  The answer in medicine is obvious.

NY Times/Steve Lohr asks "Why the Economic Payoff From Technology Is So Elusive." The answer in medicine is obvious.

In a June 5, 2016 article, New York Times reporter Steve Lohr (http://topics.nytimes.com/top/reference/timestopics/people/l/steve_lohr/index.html), who reports on technology, business and economics, asked the following question:

Why the Economic Payoff From Technology Is So Elusive
New York Times, Business Day
By STEVE LOHR
JUNE 5, 2016
http://www.nytimes.com/2016/06/06/business/why-the-economic-payoff-from-technology-is-so-elusive.html

Your smartphone allows you to get almost instantaneous answers to the most obscure questions. It also allows you to waste hours scrolling through Facebook or looking for the latest deals on Amazon.  More powerful computing systems can predict the weather better than any meteorologist or beat human champions in complex board games like chess.

But for several years, economists have asked why all that technical wizardry seems to be having so little impact on the economy. The issue surfaced again recently, when the government reported disappointingly slow growth and continuing stagnation in productivity. The rate of productivity growth from 2011 to 2015 was the slowest since the five-year period ending in 1982.

Healthcare becomes the gravamen of the article:

One place to look at this disconnect is in the doctor’s office. Dr. Peter Sutherland, a family physician in Tennessee, made the shift to computerized patient records from paper in the last few years. There are benefits to using electronic health records, Dr. Sutherland says, but grappling with the software and new reporting requirements has slowed him down. He sees fewer patients, and his income has slipped.

Unfortunately, the advisors who helped him with the article may have provided incomplete information:

... “The government funding has made a huge difference,” said Dr. Ashish Jha, a professor at the Harvard School of Public Health. “But we’re seeing little evidence so far that all this technology has had much effect on quality and costs.”

In the face of, among many others, a stunning letter from 40 medical societies to HHS in 2015 that the technology is unfit for purpose (http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf), known and hair-raising defects (http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and many other complaints from physicians and nurses (e.g., http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html, http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html, query link http://hcrenewal.blogspot.com/search/label/glitch as just a few examples), such a statement is anserine.

Why would anyone expect (good) effects on "quality and costs" of healthcare when the technology is so unfit for purpose in design and implementation that it has alienated most of its users?  

I've written previously about Jha's views in a May 27,  2009 post "Harvard's EMR Justification: We Just Have To Do Something" (http://hcrenewal.blogspot.com/2009/05/harvards-emr-justification-we-just-have_27.html):

 ... "I'm not suggesting EHR is going to be a panacea, but the one thing that is absolutely true is there is nothing else out there now that has any more political appeal," Jha says. "Everybody agrees, whether you are a conservative, moderate, or liberal, that we have to do something about healthcare. So the one place where we can all come to agreement is we have to do something about electronic records."

I do not think "political appeal" is a good justification for a multi-billion dollar cybernetic experiment in medicine, where the risks of the technology are considerable and where basic healthcare needs are not being well met among the poor and underprivileged.

Former ONC Chair David Brailer is quoted:

“People confuse information automation with creating the kind of work environment where productivity and creativity can flourish,” said Dr. David J. Brailer, who was the national health technology coordinator in the George W. Bush administration. “And so little has gone into changing work so far.”

Brailer was little better than Jha, and moves the goalposts with a type of circular logic.  He appears to be saying that technology that will revolutionize medicine can't work until we change how things are done in medicine so the technology can revolutionize medicine. 

The article then quotes one Tennessee physician, a Dr. Sutherland, who is "happy" to accept bad health IT, a resultant pay cut, and increased work:

... Today, Dr. Sutherland’s personal income and the medical group’s revenue are about 8 percent below where they were four years ago. But in 2015, both his earnings and the revenue of Healthstar, which employs 350 people in 10 clinics, increased slightly, by nearly 3 percent from 2014.

... Dr. Sutherland bemoans the countless data fields he must fill in to comply with government-mandated reporting rules, and he concedes that some of his colleagues hate using digital records. Yet Dr. Sutherland is no hater. Despite the extra work the new technology has created and even though it has not yet had the expected financial payoff, he thinks it has helped him provide better information to patients.

He values being able to tap the screen to look up potentially harmful drug interactions and to teach patients during visits. He can, for example, quickly create charts to show diabetes patients how they are progressing with treatment plans, managing blood glucose levels and weight loss.

He is working harder, Dr. Sutherland says, but he believes he is a better doctor. Blunt measures of productivity, he added, aren’t everything. “My patients are better served,” he said. “And I’m happier.”

While being able to provide fancy charts and check drug-drug interactions (for which a massive and expensive EHR is certainly not needed; a PDA will suffice) is fine.

However, anyone who gladly accepts a pay cut, and inconvenience, and harder work due to bad health IT, and is a happy camper with that state of affairs, either suffers from the Stockholm syndrome or has a lot of discretionary income and free time to spare that many clinicians do not.  

The article fails to mention the hundreds of thousands of other US docs and others in other lands (e.g., http://hcrenewal.blogspot.com/2016/05/hit-mayhem-canadian-style-nanaimo.html) who aren't happy at all with health IT as it is today.  

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

I sent this email to Mr. Lohr.

From: S Silverstein
To:Steve Lohr 
Date: Tue, Jun 7, 2016 at 10:02 AM
Subject: Re: Why the Economic Payoff From Technology Is So Elusive

Dear Mr. Lohr,

In medicine, the answer to this question is straightforward.  I don't know if Ashish Jha brought this to your attention, or if he himself is aware of it.

This letter from nearly 40 different medical societies to HHS about bad health IT is specific about how bad the current health IT is:



You should be aware of the letter's contents.  I've also attached it to this email.

In academic Medical Informatics, such matters are often ignored, as they run contrary to the narrative that IT will "revolutionize medicine"; I know, as I was Yale faculty in Medical Informatics myself. 

The assumption in academic circles and in the Administration (unfortunately) is that "all health IT is good health IT." 

Unfortunately, it is not.  From my own site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at http://cci.drexel.edu/faculty/ssilverstein/cases/ :

Definitions authored by myself and Australian informatics expert Dr. Jon Patrick:


Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, can be easily, substantively and cost-effectively customized to the needs of medical specialists and subspecialists, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. 

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, is lacking in evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

It comes as no surprise not to find productivity gains, but instead hundreds of thousands of angry physicians (and nurses), when health IT is mostly bad IT.

The health IT industry itself needs serious remediation before its products will be a boon to medicine.

Sincerely,
Scot Silverstein, MD
Drexel University, Philadelphia


p.s. I have not even broached the matter of health IT patient harms. 

Patients are being harmed and dying of bad health IT.  See for instance the CRICO insurance report at http://www.cci.drexel.edu/faculty/ssilverstein/PSQH_MalpractClaimsAnalyConfirRisksEHR.pdf
 
---------------------------------------  

I will add an addendum if I receive a reply.

-- SS
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Tuesday, 31 May 2016

HIT Mayhem, Canadian Style: Nanaimo doctors say electronic health record system unsafe, should be shut down, non-medical PR hacks say it's perfectly safe

Some candid honesty:

To hell with doctors and nurses and their concerns about horrible health IT.  

That seems the international standard in 2016 regarding their concerns.  There's just too much money to be made in this business to worry about such piddling annoyances as maimed and dead patients.

Doctors, after all, don't know anything about computers, and cybernetic medical experiments on unconsenting human subjects are just good fun.

This new example from Canada:

http://www.theprovince.com/health/local-health/nanaimo+doctors+electronic+health+record+system/11947563/story.html

Nanaimo doctors say electronic health record system unsafe, should be shut down

By Cindy E. Harnett
Victoria Times Colonist
May 27, 2016

Implementation of a $174-million Vancouver Island-wide electronic health record system in Nanaimo Regional General Hospital — set to expand to Victoria by late 2017 — is a huge failure, say senior physicians.

Who cares what they say?  They're just doctors, so sayeth the imperial hospital executives.. 

After a year of testing, the new paperless iHealth system rolled out in Nanaimo on March 19. Island Health heralds the system as the first in the province to connect all acute-care and diagnostic services through one electronic patient medical record, the first fully integrated electronic chart in the province.

EHR pioneer Dr. Donald Lindberg, retired head of the U.S. National Library of Medicine, called such total command-and-control systems "grotesque", and that was in 1969 (See http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html).  He observed back then:



But he's a doctor too, so what does he know, sayeth the hospital executives.

But nine weeks after startup, physicians in the Nanaimo hospital’s intensive-care and emergency departments reverted to pen and paper this week “out of concern for patient safety.”

Who cares what they say?  apparently not the executives, per Toni O'Keeffe, Vice President and Chief, Communications and Public Relations, http://www.viha.ca/about_viha/executive_team/toni_okeeffe.htm, as below.  The system's perfectly safe!


Doctors said the system is flawed — generating wrong dosages for the most dangerous of drugs, diminishing time for patient consultation, and losing critical information and orders.

“The whole thing is a mess,” said a senior physician. “What you type into the computer is not what comes out the other end.

“It’s unusable and it’s unsafe. I’m surprised they haven’t pulled it. I’ve never seen errors of the kind we are now seeing.”

Doctors are so concerned, they want Island Health to suspend the implementation.

“Take it away and fix it and test it before you bring it back — stop testing it on our people,” said one doctor. “Why wasn’t this introduced in Victoria first? If they went live in Victoria first, they would have a riot.”

(Is there anything unclear there, I ask?)

SHUT UP DOCTORS.  IT''S PERFECTLY SAFE, sayeth the administration.

The doctors, who fear reprisals, spoke to the Times Colonist on condition of anonymity.

If doctors did not fear reprisals I'd have a full time job writing on EHR debacles.  I could almost have one now.

The $174-million system started with a 10-year, $50-million deal for software and professional services signed in 2013 with Cerner Corporation, a health information technology company headquartered in Kansas City. Thus far, the company has been paid close to $12 million. The remaining $124 million is to be spent by Island Health for hardware, training and operating the system.

I wonder just how much graft there may be, driving what seems an international phenomenon of bad health IT with doctors and nurses complaining (e.g., examples of mayhem at http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html), patients being harmed and dying (e.g., ECRI Deep Dive study at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html), yet hospital execs and government officials gleefully moving full steam ahead.

The system is being used in Nanaimo’s hospital, Dufferin Place residential care centre (also in Nanaimo), and Oceanside Health Centre in Parksville.

Since March 19, mobile touch-screen computer console carts have been rolling around hospital hallways. Voice-recognition dictation software immediately transcribes a doctor’s verbal notes into a patient’s electronic record, and scanners track each bar-coded patient bracelet around the hospital. But doctors complain the new technology is slow, overly complicated and inefficient.

Today's clinical IT is needlessly and blindingly complex.  But hospital executives are, in my increasing view, too ignorant to recognize the necessity of simplicity in critical functions such as clinical medicine.  Their jobs are child's play in comparison.  (I should know; I once was a health IT  executive after having practiced medicine for a number of years.)

“The iHealth computer interface for ordering medications and tests is so poorly designed that not only does it take doctors more than twice as long to enter orders, even with that extra effort, serious errors are occurring on multiple patients every single day,” wrote one physician at the Nanaimo hospital.

In view of current warnings and that which is known, and has been known for many years from the literature about bad health IT, each and every adverse outcome of injury that occurs represents hospital executive gross negligence:

Gross negligence is a conscious and voluntary disregard of the need to use reasonable care, which is likely to cause foreseeable grave injury or harm to persons, property, or both. It is conduct that is extreme when compared with ordinary Negligence, which is a mere failure to exercise reasonable care.  http://legal-dictionary.thefreedictionary.com/gross+negligence

I leave it to the reader to classify patient deaths.

“Tests are being delayed. Medications are being missed or accidentally discontinued.”

My mother and other patients in whose litigation I have provided informatics expertise were injured and/or died from precisely that type of mistake.

Doctors can’t easily find information entered by nurses, the physician wrote.

There are also complaints about the pharmacy module of Cerner’s integrated system — the only joint build between Island Health and Cerner.

iHealth implementation staff brought in to input orders for physicians this week entered eight drug mistakes on one day and 10 on another, while there were no mistakes in the paper orders, doctors said. “If the experts can’t enter it correctly, what is the average Joe going to do?” one doctor said.

Suffer, and take on all the liability, of course.

Another problem, they said, is patients’ drug orders disappearing from the system.

Australian informatics expert Jon Patrick wrote of such issues in 2011 as at this link: http://hcrenewal.blogspot.com/2011/03/on-emr-forensic-evaluation-from-down.html.  His technical paper was ignored, and pushback for having written it draconian.

Here's the administration's view:

... But Island Health spokeswoman Antoniette O’Keeffe said the system is safe and doing what it’s intended to do.

To hell with the doctors concerns and with the patients.

“We are not going back to paper,” she said. “We can’t go back to paper. We don’t have the mechanics to go back to paper.”

I'll be generous about the stupidity represented by that statement.  What she means is, we've jsut blown tens of millions of dollars on computers.  We'd get out asses kicked by the Board if we admitted we blew it and went back to paper.

Island Health acknowledges that documentation for staff doing emergency-department patient intake was a challenge, noting Nanaimo is the busiest emergency department on the Island.

A mere "challenge."  How about "was not possible in a 24 hour day?"

Nanaimo has some of the top physicians in the country and “we respect the feedback they are giving us, and so we are listening to them and we are tweaking and modifying the system,” O’Keeffe said.

We respect their feedback.  They say it should be shut down, but "the system is safe and doing what it’s intended to do."

Challenges include getting medication orders into the system, getting clinical staff trained, work flow and documentation, O’Keeffe said.

More staff have been added to speed up admissions and others are working around the clock in the intensive-care and emergency departments to input handwritten physician orders into the system, O’Keeffe said.

Cerner is working with Island Health staff, “and they’ll be here until we get this fully implemented,” O’Keeffe said.

Ms. O'Keefe. bad health IT is never "fully implemented."  (e.g., http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html) Instead, clinicians learn to work around bad health IT, except when the risk of doing so slips through and patients get maimed or killed.

Island Health credits the system’s electronic warnings for catching about 400 human-caused medication errors and conflicts at three sites, saying it’s a sign that the system is working. It will produce a warning, for example, if the dosage is too high for a patient’s weight, if the drug is not appropriate for a particular disease or if there’s a drug conflict.

Across the country, thousands of medication mistakes are made daily due to human error, “and this system is designed to catch them,” O’Keeffe said.

Doctors respond that so many irrelevant flags pop up, it creates confusion, while the computer loses or duplicates drug orders.

Ms. O'Keefe and her administration are obviously blissfully unaware of how health IT can cause medication errors en masse impossible with paper, e.g., "Lifespan (Rhode Island): Yet another health IT 'glitch' affecting thousands", http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html.  Of course, many hospital executives are ill-informed, lacking the curiosity of  the average scientist or physician.

The system was a decade in the making for Island Health. Twenty-three clinical teams were involved in developing various components and there was user-group testing, modifications and feedback, O’Keeffe said. Training has gone on for the last year, she said. “You can only bring a system so far and then you have to put it in a real environment to test it.”

At best - test it - yes, on unsuspecting human subjects known as patients, doctors and nurses.  The ones who are harmed and the ones who die are worthy human sacrifice for the glory of computing, eh, Ms. O'Keefe?

At worst - what is wrong with this industry that each and every installation of this technology is an experiment?

Is it that the technology has exceeded the intellectual horsepower of available personnel?  In my experience that has seemed to be the case.

By the end of the implementation, it’s expected family doctors will also be able to access patient files started in acute-care settings. Island Health is working on that component now, O’Keeffe said. Once the system is working smoothly in Nanaimo, it will be installed in the north Island and then Victoria hospitals in 12 to 18 months, O’Keeffe said.

Runaway trains cannot be stopped.

Canadian lawyers, take note.

-- SS

Addendum: An Op-Ed on this matter is here:

http://www.timescolonist.com/opinion/op-ed/comment-new-computer-system-a-detriment-to-health-care-1.2264274  

It is grim, written by a doctor under a pseudonym (Dr. Winston Smith is the pseudonym for a doctor in Nanaimo - that says much about fear of retaliation):
One health record. Making care delivery easier for health-care providers. Safer health care. These are the claims Island Health has made publicly for its new electronic health-record system iHealth, introduced initially at Nanaimo Regional General Hospital in March and intended to roll out across Vancouver Island in the coming months.
These are goals physicians share — many of whom enthusiastically use electronic records in their clinics. Despite “bumps in the road,” Island Health claims the implementation of the system is going well.
But these claims are untrue. iHealth does not provide a single health record: It offers no less disjointed and poorly accessible a collection of patient information in differing programs and sites than the previous system.
The system is cumbersome, inefficient, not intuitive — and not simply because it is a new system, but because of its very nature. It’s like trying to make a DOS-based computer work like an Apple or Windows-based system: You can perform many of the same functions, but it is slow, takes multiple steps and is inefficient.
Even the youngest generation, who have grown up with computers, and those with computing science degrees can’t make it work effectively.
The system’s ordering function is faulty and requires multiple separate steps and choices to order a simple medication: A processing issue safety experts know is highly likely to cause error.
And the system sometimes makes default changes in medication orders without the knowledge of the ordering physician. Single orders for medications disappear from the record, so that duplicate orders are initiated by unknowing doctors.
The consequence of these problems is that hospital-based care delivery is slower, more inefficient, more prone to error. Health-care providers are found interacting with their mobile computer monitors in already overcrowded hallways rather than providing direct patient care.
Nurses and doctors have less of a holistic appreciation of their patients and their illnesses because of the disjointed complexity of the electronic record rather than the simple navigability of the previous paper record and charting.
And communication with the computer system has supplanted direct discussion between health-care team members: Like trying to manage complex illnesses through text messages.
Health-care delivery is slower, so surgical operations are cancelled or delayed and patients leave the emergency department without being assessed; patients are not seen in a timely fashion or at all by specialists; medication errors are regular, so patients are medicated inappropriately or even overdosed; and some of our most experienced and valued health-care providers opt for early retirement or leave rather than continue the frustration and moral distress that this system has generated.
And the effect of iHealth is not restricted to the hospital, as some specialists have reduced their outpatient service because of the increased workload iHealth has caused.
In short, health care is not easier or better. The quality of care is worse and access is reduced. Improvements can be made and have been, but the system is fundamentally flawed. The impact on work efficiency and quality will never return to previous levels — a fact even the Island Health iHealth “champions” acknowledge.
Worse, iHealth is unsafe and dangerous. Medicine strives to be evidence-based, but there’s no evidence electronic record systems improve quality of care, and plenty of evidence they do the opposite — particularly this one.
Doctors have expressed their concerns to Island Health. Rather than suspending the system, the health authority’s response has been simply to delay its rollout beyond Nanaimo. It’s OK to let our community suffer while they tinker.
Dr. Brendan Carr, the CEO of Island Health, tells us he’ll “do whatever it takes to make this work,” even while continuing to risk worsening quality of care and expending more of our taxpayer dollars — $200 million so far, a fraction of which applied to delivery of health-care services could provide inordinately better health-care outcomes than any electronic record can do.
The medical community has finally taken matters into our own hands in the interests of patient safety, quality of care and access. A number of departments are refusing to continue using the system and instead returning to the previous one.
Why does Island Health not withdraw this system? In sum, they’ve spent a lot of taxpayers’ dollars on iHealth, a product of Cerner, which has been sued by hospital systems in the United States.
And as with many such systems, the objective has not been better patient care, but has been more Orwellian: Improved administrative data and control — no wonder Island Health is loath to give it up.
Well, Dr. Carr, the patient should be paramount. I and my family and my community are not expendable. No electronic record system should be introduced that will not explicitly improve health care, patient safety and access.
Any deterioration in health care is not an acceptable outcome. Suspend the iHealth experiment. Stop wasting taxpayer dollars. Sue for our money back for having been sold a lemon (as other jurisdictions have done).
Spend our tax dollars on services, infrastructure and equipment that will improve health care, not make it worse.
Dr. Winston Smith is the pseudonym for a doctor in Nanaimo.
- See more at: http://www.timescolonist.com/opinion/op-ed/comment-new-computer-system-a-detriment-to-health-care-1.2264274#sthash.rWwQcJZA.dpuf

... The system is cumbersome, inefficient, not intuitive — and not simply because it is a new system, but because of its very nature. It’s like trying to make a DOS-based computer work like an Apple or Windows-based system: You can perform many of the same functions, but it is slow, takes multiple steps and is inefficient.

Even the youngest generation, who have grown up with computers, and those with computing science degrees can’t make it work effectively.

The system’s ordering function is faulty and requires multiple separate steps and choices to order a simple medication: A processing issue safety experts know is highly likely to cause error.

And the system sometimes makes default changes in medication orders without the knowledge of the ordering physician. Single orders for medications disappear from the record, so that duplicate orders are initiated by unknowing doctors.

Deadly.

The consequence of these problems is that hospital-based care delivery is slower, more inefficient, more prone to error. Health-care providers are found interacting with their mobile computer monitors in already overcrowded hallways rather than providing direct patient care.

This was not what the pioneers intended.

Nurses and doctors have less of a holistic appreciation of their patients and their illnesses because of the disjointed complexity of the electronic record rather than the simple navigability of the previous paper record and charting.

That sums up a major problem with today's health IT well.

The medical community has finally taken matters into our own hands in the interests of patient safety, quality of care and access. A number of departments are refusing to continue using the system and instead returning to the previous one.

This type of revolt, showing who really owns the hospital, needs to become commonplace.

Why does Island Health not withdraw this system? In sum, they’ve spent a lot of taxpayers’ dollars on iHealth, a product of Cerner, which has been sued by hospital systems in the United States.

And as with many such systems, the objective has not been better patient care, but has been more Orwellian: Improved administrative data and control — no wonder Island Health is loath to give it up.

Indeed.

The CEO is himself a physician:

Well, Dr. Carr, the patient should be paramount. I and my family and my community are not expendable. No electronic record system should be introduced that will not explicitly improve health care, patient safety and access.

This anonymous doctor needs to speak to my mother, who I visited yesterday along with my father, on U.S. Memorial Day - at the cemetery after her encounter with bad health IT.

Read the whole Op Ed at the link above.

-- SS
New computer system a detriment to health care
New computer system a detriment to health care
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Wednesday, 30 March 2016

Bad health IT at Medstar Health: FBI probing virus behind outage (And: ka-ching! ka-ching!  EHR costs continue their upward spiral)

Bad health IT at Medstar Health: FBI probing virus behind outage (And: ka-ching! ka-ching! EHR costs continue their upward spiral)

Once again, a 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, 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 evidentiary fitness, or otherwise demonstrates suboptimal design and/or implementation. (http://cci.drexel.edu/faculty/ssilverstein/cases/)

I observed bad health IT leading to HIT compromise, hospital chaos and paying of a ransom demand at my Feb. 18, 2016 post "Hollywood Presbyterian Medical Center: Negligent hospital IT leaders allow hacker invasion that cripples EHRs, disrupts clinicians ... but patient safety and confidentiality not compromised" at http://hcrenewal.blogspot.com/2016/02/hollywood-presbyterian-medical-center.html.

It's happened again, at least with regard to publicly-disclosed stories (there is no requirement for hospital disclosure, more on that below).

FBI probing virus behind outage at MedStar Health facilities - AP
By JACK GILLUM, DAVID DISHNEAU and TAMI ABDOLLAH March 28, 2016 10:04 pm
http://wtop.com/consumer-tech/2016/03/fbi-probing-virus-behind-outage-at-medstar-health-facilities/


WASHINGTON (AP) — Hackers crippled computer systems Monday at a major hospital chain, MedStar Health Inc., forcing records systems offline for thousands of patients and doctors. The FBI said it was investigating whether the unknown hackers demanded a ransom to restore systems.

A computer virus paralyzed some operations at Washington-area hospitals and doctors’ offices, leaving patients unable to book appointments and staff locked out of their email accounts. Some employees were required to turn off all computers since Monday morning.

A law enforcement official said the FBI was assessing whether the virus was so-called ransomware, in which hackers extort money in exchange for returning a victim’s systems to normal. The official spoke on condition of anonymity because the person was not authorized to discuss publicly details about the ongoing criminal investigation.


Not discussed is corporate accountability for deficient IT security.

“We can’t do anything at all. There’s only one system we use, and now it’s just paper,” said one MedStar employee who, like others, spoke on condition of anonymity because this person was not authorized to speak to reporters.

I note that if the cybernetic pundits were listened to, patients would now be considered at deadly risk due to paper records being used - not due to critical IT infrastructure being hacked and disabled.  Yet it's impossible to disable paper charts en masse.

MedStar said in a statement that the virus prevented some employees from logging into systems. It said all of its clinics remain open and functioning and there was no immediate evidence that patient information had been stolen.

These must be honest thieves.

Of course, we hear the "patient care has not been compromised" line once more (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).

Company spokeswoman Ann Nickels said she couldn’t say whether it was a ransomware attack. She said patient care was not affected and the hospitals were using a paper backup system.

The absurdity of this claim is that if patient care is not affected by returning to paper, then why did the hospital invest hundreds of millions on EHRs?

(Considering a increasing evidence base of clinician distraction and disaffection e.g., the Jan. 2015 Medical Societies letter to ONC as at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html, EHR-related errors, many of which would likely not occur under a well-staffed paper system e.g., as at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html, and plentiful security breaches e.g., the many posts at http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy, I would also ask if patient care is in fact improved by the return to paper [1].)

When asked whether hackers demanded payment, Nickels said: “I don’t have an answer to that,” and referred to the company’s statement.

Dr. Richard Alcorta, medical director for Maryland’s emergency medical services network, said he suspects it was a ransomware attack. He said his suspicion was based on multiple earlier ransomware attempts on individual hospitals in the state. Alcorta said he was unaware of any ransoms paid by Maryland hospitals or health care systems.

The rather calmly-stated "multiple earlier ransomware attempts on individual hospitals in the state" suggests that

  • Hospitals are being targeted in an organized fashion, and
  • Costs to implement proper security will draw even more capital and resources from direct patient care and from real brick and mortar facilities, such as entire new hospital wings that would cost less than an EHR, to cybernetics of increasingly dubious value.  (Past projected cost benefits are certainly being proven even more naive.)

Terrorism or just plain old crime, the medical driector asks...

“People view this, I think, as a form of terrorism and are attempting to extort money by attempting to infect them with this type of virus,” he said.

God help us if true terrorists get in the act of cybernetically paralyzing hospitals.

Alcorta said his agency first learned of MedStar’s problems about 10:30 a.m., when the company’s Good Samaritan Hospital in Baltimore called in a request to divert emergency medical services traffic from that facility. He said that was followed by a similar request from Union Memorial, another MedStar hospital in Baltimore. The diversions were lifted as the hospitals’ backup systems started operating, he said.

It used to be that patient diversions were due to doctors and nurses having too many sick patients they are caring for.  Here it seems due to doctors having to many sick computers to deliver proper patient care.

MedStar operates 10 hospitals in Maryland and Washington, including the MedStar Georgetown University Hospital, along with other facilities. It employs 30,000 staff and has 6,000 affiliated physicians.

That's a lot of paralysis.

Monday’s hacking at MedStar came one month after a Los Angeles hospital paid hackers $17,000 to regain control of its computer system, which hackers had seized with ransomware using an infected email attachment.

Hollywood Presbyterian Medical Center, which is owned by CHA Medical Center of South Korea, paid 40 bitcoins — or about $420 per coin of the digital currency — to restore normal operations and disclosed the attack publicly. That hack was first noticed Feb. 5 and operations didn’t fully recover until 10 days later.

Hospitals are considered critical infrastructure, but unless patient data is impacted there is no requirement to disclose such hackings even if operations are disrupted.

I won't even comment on why a US hospital is owned by a Korean medical center.  The statement "unless patient data is impacted there is no requirement to disclose such hackings even if operations are disrupted" implies yet another blind spot in the unregulated health IT industry.  Add that to the blindness towards close-calls and actual harms, and you have a field being pushed on the population under penalty by those somewhat deaf, dumb and blind to the downsides.


Computer security of the hospital industry is generally regarded as poor, and the federal Health and Human Services Department regularly publishes a list of health care providers that have been hacked with patient information stolen. The agency said Monday it was aware of the MedStar incident.

All I can hear is "ka-ching! ka-ching!" as the costs to fix the poor computer security in the hospital industry accrues. 

How much will patient care suffer as a result of the diversion of yet more resources to cybernetics?

As I've written before, stories like this support a serious rethinking of the entire healthcare IT hyper-enthusiast movement to whom the considerable downsides (even patient death) are just an unfortunate "bump in the road" (http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html), or perhaps more accurately, the healthcare IT hyper-enthusiast religion.

-- SS

[1] I've written that paper for many clinical settings, including highly specialized forms as I implemented highly successfully in invasive cardiology (http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story), needs reconsideration, relieving clinicians of clerical work and employing data entry clerks to enter the data.  This would be supplemented by far less expensive document imaging systems for 24/7 availability, and computerized lab results retrieval - the latter with appropriate humans on the receiving end to prevent the "silent silo" syndrome of lab results returned to a computer silo but missed by clinicians due to being very busy and due to unreliable/fatiguing cybernetic alerting.  A lot of workers can be paid for by saving $50 or $100 million on software.

3/30/2016 Addendum:

This is not the first time for EHR outages at MedStar.

As in my May 16, 2015 post "Another day, another EHR outage: MEDSTAR EHR goes dark for days" at http://hcrenewal.blogspot.com/2015/05/another-day-another-ehr-outage-medstar.html, I cited Politico. 

The doctor's observation I highlighted below is of interest.

4/9/15
http://www.politico.com/morningehealth/0415/morningehealth17818.html

MEDSTAR EHR GOES DARK FOR DAYS: MedStar’s outpatient clinics in the D.C. and Baltimore area lost access to their EHRs Monday and Tuesday when the GE Centricity EHR system crashed. The system went offline for scheduled maintenance on Friday and had come back on Monday when it suffered a “severe” malfunction, according to an email from Medstar management that was shared with Morning eHealth.

“All of a sudden the screens lit up with a giant text warning telling us to log off immediately,” a doctor said. “They kept saying it would be back up in an hour, but when I left work Tuesday night it was still down.”

This doctor told us that the outage was “disruptive and liberating at the same time. I wrote prescriptions on a pad for two days instead of clicking 13 times to send an e-script. And I got to talk to my patients much more than I usually do.

But of course we didn’t have access to any notes or medication history, and that was problematic.” MedStar notified clinicians in the email that any information entered in the EHR after Friday was lost.

-- SS


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Thursday, 17 March 2016

Criminal matter for the Attorney General of NY?  Hail the gods of medical computing, and the need for human sacrifice.  NYC’s $764M medical records system will lead to ‘patient death’: insiders

Criminal matter for the Attorney General of NY? Hail the gods of medical computing, and the need for human sacrifice. NYC’s $764M medical records system will lead to ‘patient death’: insiders

I believe the suffering and death of my mother in 2010-2011 due to EHR flaws - including but not limited to lack of essential confirmation dialogs on medication deletion at triage, lack of notification messages informing down-line staff of such action by unqualified personnel (inadequate support of teamwork), and other issues - lends me some moral standing to comment on the following as a horrifying and potentially criminal matter.  (See http://khn.org/news/scot-silverstein-health-information-technology/).


Two back-to-back articles appeared in the New York Post:


NYC’s $764M medical records system will lead to ‘patient death’: insiders
By Michael Gartland
March 15, 2016
http://nypost.com/2016/03/15/nycs-764m-medical-records-system-will-lead-to-patient-death-insiders/

and

Hospital exec [CMIO] quits, compares $764M upgrade to Challenger disaster
By Michael Gartland
March 16, 2016
http://nypost.com/2016/03/16/hospital-exec-quits-compares-764m-upgrade-to-challenger-disaster/ 


It is well-known and indisputable that this technology can and does injure and kill, especially when poorly designed, defective, poorly implemented, or all of the above.  See for instance the ECRI EHR risk Deep Dive study results at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.

Any official in leadership of health IT who denies this - or sidesteps it - or makes excuses for compromises on health IT safety, especially in view of dire warnings from clinician experts - in 2016 is guilty of conduct of the type below:

http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html
What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.

Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.

The two articles reflect a good possibility that the politics of what I'd once termed "cybernetics über alles" has trumped patient safety concerns in NYC.

Here's details from the first article:

A new $764 million medical records system is launching at the municipal hospital system on April 2 — even though insiders warn it isn’t ready and patients will suffer.

The soft launch of the electronic system Epic is scheduled at Elmhurst and Queens hospitals.

“Sooner or later, it will crash,” said one source involved in the project. “There will be patient harm — patient harm and patient death.”

That sounds like insiders warning of far more problems than mere crashes causing patient harm and death, a brave act considering possible retaliation.

I wonder if the users of this EPIC system are having imposed on them the speech and though controls imposed on users at University of Arizona (see my Oct. 3, 2013 post "Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As 'Advised' At The University Of Arizona Health Network" at http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html).

Sources say Dr. Ramanathan Raju, who runs the municipal network, NYC Health + Hospitals, is under the gun from City Hall to meet the deadline and fears he’ll be fired if he doesn’t.

“Raju has said too many times to count that the Mayor’s Office has told him if April 1st doesn’t happen, then Ram will lose his job,” one source said.

The source added that Raju has threatened to fire top executives if the project doesn’t launch on time.

If this is true, than the "gun" from City Hall is aimed straight at patients, and if patients indeed are mortally affected, the responsible officials might be deemed accessories to murder.

I add that this type of situation represents fundamental and severe mismanagement, as I'd been writing about since the late 1990's at my academic site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at http://cci.drexel.edu/faculty/ssilverstein/cases/.

The hospital system is already on City Hall’s watch list, having required a $337 million bailout in January to stay afloat. 

Money for EHR's grows on trees.

Note other hospitals where EHR implementations led to financial disaster (e.g., http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html, http://hcrenewal.blogspot.com/2013/05/clouded-visionary-leadership-wake.html, http://hcrenewal.blogspot.com/2013/06/want-to-help-hospital-go-bankrupt-get.html, http://hcrenewal.blogspot.com/2014/06/100-million-epic-install-dampens.html as examples).

Insiders contend that the only safe way to roll out Epic is to take more time — about three months — to address several key issues.

One is planning for a crash, which some consider almost inevitable because the new setup hasn’t been configured to work with systems at other hospitals or with some of its own internal billing and tracking software.

Existing patient data also has to be transferred from the old system — a process that would normally take six months, but which was shoehorned into less than one.

Going "live" with a half-baked EHR under such circumstances for political reasons, if these facts are true, would be, in my professional opinion, an act worthy of prison time if harm results.

“There are supposed to be all these dry runs,” a source said. “They haven’t been done.”

Again, if true, this reflects expediency at the expense of patient well-being, by rows of political hacks, fools and incompetents calling the shots in an area in which they have no business being involved.

City officials contend Epic remains “on-time and within budget.”

I have a feeling this will be revisited at some time in the future - in court.

A mayoral spokeswoman said there would be a round-the-clock effort to ensure there are no glitches. 

"No glitches?" 

That is a hollow promise that cannot be kept even under the best of circumstances.  Under the hellish circumstances described, such a statement is outright frightening. The Mayor truly has no clue about EHR "glitches", but I offer the many posts at query link http://hcrenewal.blogspot.com/search/label/glitch for his education.

Mr. Mayor, here's an example of EPIC and other EHR implementations under the best of circumstances.  These systems are so immensely complex, trying to be pressure-fit into a vastly complex, varying and changing environment, that to not heed CMIO and other expert warnings is the height of recklessness:


Of course, we are reassured that the crack team assigned the implementation duties will produce stellar results:

“NYC Health + Hospitals and its Epic implementation experts are prepared to implement the new system in Queens facilities beginning April 2, and have assembled a team of about 900 technicians and Epic experts who will work around-the-clock that week both in Queens and at remote data centers to ensure the transition to the new system goes as smoothly as possible,” said spokeswoman Ishanee Parikh.

EPIC experts like these?  From this link at the "Histalk" site on staffing of health IT projects, Aug. 16, 2010. Emphases mine:

Epic Staffing Guide 

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

Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say. 

The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores. 

I bet many readers were taught by their HR departments to do behavioral interviewing, i.e. “Tell me about a time when you …” Epic says that’s crap, suggesting instead that candidates be given scenarios and asked how they would respond. They also say that interviews are not predictive of work quality since some people just interview well. 

Don’t just hire the agreeable candidate, the guide says, since it may take someone annoying to push a project along or to ask the hard but important questions that all the suck-ups will avoid. 

Epic likes giving candidates tests, particularly those of the logic variety.

The part about "not worrying about relevant experience" and about "hiring recent college graduates as HIT project analysts" is bizarre if true, and downright frightening.

Medical environments and clinical affairs are not playgrounds for novices, no matter how "smart" their grades and test scores show them to be. These practices as described, in my view, represent faulty and dangerous advice on first principles.  The advice also is at odds with the taxonomy of skills published by the Office of the National Coordinator I outlined at the post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership."

The second NY Post article cited above is even more dire:

A senior official was so worried a new $764 million medical records system for the municipal hospital system was launching too early that he resigned, comparing it to the disastrous space shuttle Challenger launch in 1986.

In a “resignation and thank-you” email last week, Dr. Charles Perry urged colleagues at NYC Health + Hospitals — formerly the Health and Hospitals Corp. — to sound the alarm and press for an “external review” to stop the system from going live next month.

Perry was chief medical information officer of Queens and Elmhurst Hospital Centers, the first scheduled to get the new electronic medical data system.

When a CMIO - a role I held in the mid 1990s -  resigns under such circumstances, a project should be halted in its tracks and external examination begun.  Instead, it appears we have spin control.

In his email, Perry offered a comparison to the launch of the Challenger — aboard which seven crew members died when it exploded 73 seconds after liftoff on Jan. 28, 1986 — and cited a presidential panel’s report examining how the disaster occurred.

That is as dire and direct a warning as they come.  Unqualified individuals who second guess such a warning should be held legally accountable for adverse outcomes.

(Such a warning letter about EHRs now sits as "Exhibit A" in the lawsuit complaint regarding my dead mother.  It had not been heeded.)

“For a successful technology, ­reality must take precedence over public relations, for nature cannot be fooled,” Perry wrote in his ­email, quoting from the report.

But fools in leadership roles in health IT think they can fool Mother Nature.

Perry went on to urge a short delay despite “vehement entreaties to make the April 1st date by officials and consultants with jobs and paydays on the line.”

This is exactly how patients end up maimed and dead.

Agency president Dr. Ramanathan Raju has repeatedly told colleagues his job is on the line if the deadline isn’t met, sources said.

Perry, a medical doctor with an MBA, declined to comment.

Maybe Raju should quit, too.  He should know that Discovery over such matters would not be very pleasant, especially if I am assisting attorneys in such matters - which could very well occur.

“He [Perry] took a stand,” said one insider. “He wasn’t going to take part in something that was going to compromise patient safety.”

It's good to know someone in Medical Informatics still has balls.

The idea that we’d jeopardize patients to meet a deadline is simply wrong,” said Karen Hinton, Mayor Bill de Blasio’s spokeswoman.

“If a patient safety issue is identified, the project will stop until it is addressed.

“NYC Health + Hospitals and its Epic implementation experts have assembled a team of about 900 technicians and Epic experts who will work around the clock through the week surrounding the transition in both Queens and at remote data centers to ensure we shift to the new system as smoothly as possible.”

It's been said that one expert who truly know what they're doing will always outperform 1,000 (or 900) generalists following the finest of "process" who are in over their heads (to wit, 900 generic musicians could never exceed the work of Beethoven or Brahms).

In this matter, I take the CMIO's word over the 900 techies and "experts", once having voiced such concerns myself.

-- SS

What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.
Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.
Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.
Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.
Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf

What is Criminal Negligence?

Under some criminal law statutes, criminal negligence is defined as any type of conduct that “grossly deviates” from normal, reasonable standards of an ordinary person.  It generally involves an indifference or disregard for human life or for the safety of people.  Sometimes the definition for criminal negligence also requires a failure to recognize unjustifiable risks associated with the conduct.
Examples of criminally negligent behavior may include knowingly allowing a child to be in very dangerous conditions, or driving in an extremely irresponsible way.  Criminal negligence is less serious than intentional or reckless conduct.  Generally, reckless conduct involves a knowing disregard of risks, while negligence involves an unawareness of the risks.
- See more at: http://www.legalmatch.com/law-library/article/criminal-negligence-laws.html#sthash.3YLT7ahF.dpuf
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Friday, 5 February 2016

HIMSS 2016 Presentation: Plaintiff's Lawyers Are The Cause of EHR Problems. They're Using Pristine, White-as-the-Blowing-Snow EHRs as "An Opportunity for Litigation"

In perhaps the most ill-informed, perverse rationalization/defense of bad health IT I've seen to date, the following appeared in an article about an upcoming HIMSS presentation (Healthcare Information and Management Systems Society's health IT mega-industry trade show, http://www.himssconference.org).

I remind readers of the definition of bad health IT coined by myself and Australian polymath/informatics scientist Dr. Jon Patrick in 2012, as at my Drexel University College of Computing and Informatics website "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" 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.

To this definition I should add "that does not support evidentiary trustworthiness."

The article tries to make the case that Plaintiff's lawyers are "targeting" the innocent EHR:


Amid surge in malpractice lawsuits, EHRs often targeted in litigation, attorney says
Healthcare IT News, Feb. 4, 2016
Greg Goth
http://www.healthcareitnews.com/news/amid-surge-malpractice-lawsuits-ehrs-often-targeted-litigation-attorney-says

Byline:  Providers often wind up defending their electronic health records, rather than what got them sued in the first place, Mary Re Knack will explain at HIMSS16

The article continues:


As if healthcare executives don't have enough worries about implementing electronic health records, yet another issue is starting to ramp up.

"What's been happening more frequently in the last few years is that certain plaintiffs' lawyers – a kind of group of them who communicate with each other – have started to see the medical record as an opportunity for litigation," said Mary Re Knack, a Seattle-based attorney for the firm Ogden Murphy Wallace.

Knack will be presenting an exploration of these emerging litigation troubles in the session "Just Press Print: Challenges in Producing EHRs in Litigation" with colleague Elana R. Zana at HIMSS16, beginning in late February.

A group of colluding plaintiff's lawyers "see the medical record as an opportunity for litigation?"   This statement appears to say, in the words of a colleague, "it's those $%$%# plaintiff's attorneys again, preying on our worthy docs and hospitals and their good intentions with HIT for the nation's good."

Ms. Knack seems to veer in the direction of the Defense side as at http://www.omwlaw.com/seattle-attorneys/m-re-knack/:


Ms. Knack is a member of the Healthcare and Litigation Departments.  Her practice focuses on healthcare, insurance, product liability, mass tort, and civil matters.  Ms. Knack provides a wide range of legal services to members of the healthcare industry including negotiating and structuring arrangements, business, regulatory, confidentiality and privacy-related compliance services including HIPAA and state laws, licensing and risk management related services, and related investigations.

The reality in my direct experience is different.  Starting after the EHR-related injury and demise of my mother in 2010, I began lending my medical informatics expertise to lawyers as an Independent Expert Witness towards deciphering and authenticating the legible gibberish that often passes for "medical records."  In working with and speaking at national meetings to Plaintiff's lawyers at their invitation, I find that the only thing plaintiff's lawyers see EHRs as is a badly-designed tool that causes or contributes to medical malpractice itself by disrupting doctors and nurses, and befuddles any reader, attorney or clinician, regarding the true course of clinical events.

They see, in my experience, bad health IT not as an "opportunity for litigation", but as an impediment to knowing the facts of the case, and a cause of unnecessary patient harm.

(In fact, in late 2014 I spoke to U.S. House members at the Capitol on just those issues, accompanied by several Plaintiff's attorneys who'd seen horrible patient harms as a result of bad health IT, begging the congresspeople to investigate and take action.)

An early quote in the article is, I'm sure, an inadvertent but an outright condemnation of the health IT industry:


Electronic health record design is paramount among those issues, Knack said, because EHR vendors quite naturally did not build the software with litigation in mind.

It's bad enough that EHR vendors did not build the software with clinicians and clinical care in mind, resulting in a Complaint Letter from almost 40 medical societies to HHS one year ago (see my Jan. 28, 2015 post "'Meaningful Use' not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html, which contains a link to the aforementioned medical societies letter).

Ms. Knack now avers that EHR vendors did not build the software with adequate due diligence towards evidentiary/litigation matters.

In other words, the software is not designed to produce court-ready records that can be easily shown to be complete, free from alteration, and trustworthy in order to meet the business record exception to hearsay (Also known as the Business Entry Rule, this exception to the evidentiary rule, which excludes hearsay from a trial, allows business records to be admitted if the proper foundation is laid to show the document is reliable, https://www.law.cornell.edu/wex/business_records_exception).

I take great issue with the declaration that such evidentiary faults were incorporated "quite naturally" by the vendors.  It's not like medical malpractice is a State Secret, and the need for records trustworthiness kept under cover by the National Security Agency.

I thus feel compelled to correct Ms. Knack's statement to read as follows:


Electronic health record design is paramount among those issues, Knack said, because EHR vendors quite negligently did not build the software with litigation in mind.

Next:


"The data is all stored behind these templates, and depending on what you are trying to look at, whether it's a summary or lab reports or such, the data then populates the template on a screen. But when you print it, it doesn't print out as cleanly or as nicely,” Knack said.

In fact, the arrangement of data on the screens is often very, very bad in terms of understanding the patient (e.g., see my Dec. 6, 2013 post "EHR Pastel Madness: Cognitive Overload in Critical Care" at http://hcrenewal.blogspot.com/2013/12/ehr-pastel-madness-cognitive-overload.html).  Usability of most commercial EHRs leaves much to be desired, and that does not involve paper printouts.

That said, I do agree with Ms. Knack that paper printouts - the reams and reams that come out of these systems even after short hospitalizations - are often informationally cryptic, sloppy, filled with distracting irrelevancy, and tiring to use.  See my Feb. 27, 2011 post "Electronic Medical Records: Two Weeks, Two Reams" at http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html for instance.  (Indeed, my own mother's thousands of pages are a nightmare, even for me who trained in the paper days at the very hospital in which those records were generated, was there almost every day observing events of my mother's care in 2010-11, and who is a Medical Informatics specialist).

This raises the following questions:


  • Why doesn't that paper "print out as cleanly or nicely" as the (already problematic) screens?
  • Who designed the systems this way?  Again in my own experience as a developer and CMIO, it is not hard to produce quality output, see for instance my report at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story
  • Who approved the purchase of these systems whose paper output is not "clear and nice"?  It's not as if hospitals don't have HIM medical record experts, legal counsel, and others to have demanded better;
  • Who implemented the systems as such?
  • Who complacently leaves them in the condition of producing bad paper printouts?

(Note, an anecdote regarding the health IT Industry in the U.S.: the cardiology information system I developed, linked to above in the 2nd bullet point, was seen in 2000 by German engineers at Siemens Healthcare Erlangen as exemplary, and they offered me a position to further develop it, that I declined due to a simultaneous superior offer from Merck Research Labs.  However, in 2007 when I again spoke to Siemens, this time to Americans at the former Shared Medical Systems in Malvern, PA that had been acquired by Siemens, they found a system that actually produced clear, detailed outputs in a critical care area and was in use at the time in a major healthcare system in the region "impractical" - and never followed up with me.  Pearls before....)

Making matters far worse for the EHR sellers and those who actually bought and implemented these cybernetic behemoths, the issues of record evidentiary fitness do not just concern litigation.   That's just the tip of the iceberg:

A colleague, EHR/HIT Systems and Policy Analyst Dr. Reed Gelzer (https://www.linkedin.com/in/reed-gelzer-4410899) also points out that:

Records management fitness is required also for:

1. Accurate clinical quality measures  
2. Regulatory reporting
3. Alternate payment model services reporting
4. Release of Information for business associates of all kinds, including transitions of care
5. Valuation of clinical organizations in mergers and acquisitions
6. Data quality assurance for each and every potential end-use of clinical information that is dependent on narrative notes (all forms of workload coding/RVUs, episode-of-care costing, etc.)
7. Risk Management of all types, not just medmal.  (Including D&O - Directors & Officers - as well as the secondary and re-insurers)

A cavalier approach to evidentiary fitness thus is a gargantuan, bull-in-a-china-shop intrusion of information technology medical amateurs into the clinical setting.  The harm that is/will be caused goes far beyond the trial court.

Then this:


... One of these obvious challenges in trying to review somebody's care is how do you see it? How do you even read what the care was? Who did what? And when?

"You may have a case that's very straightforward medical malpractice, but because of the way the medical records get printed out, the same piece of data may appear in five places. Somebody who looks at it, whose goal is to show how it's confusing, can then start to challenge the care that was given based on the fact the medical record is confusing,” Knack explained. “They can take another step, and that is questioning whether the data in the medical record is accurate or if it has been changed."

In other words, Plaintiffs lawyers get a pile of evidentiary crap that is, in fact, often confusing (even to a Medical Informatics specialist/physician such as myself), and, evil upon evil, they question whether there's been any alteration or withholding of an alterable electronic record under sole control of the defendant, to prejudice plaintiffs and advantage defendant.

Medical record alteration is, unfortunately, not that uncommon.   See the search https://www.google.com/search?q=medical+record+alteration&ie=utf-8&oe=utf-8, for instance.

EHRs have a huge vulnerability in that regard.  Plaintiff attorneys are rightly being diligent in questioning the trustworthiness of records.  As it is legally incumbent upon the producer of records to prove they are what they purport to be, and since hospitals and medical professionals have an inherent conflict of interest in producing records that could damage their defense regarding malpractice, in my view the Courts should be as diligent as well before allowing records to be admitted as trustworthy business records.

Last quote from the article:


... As a result, Knack said, a healthcare provider can find itself in litigation that is ostensibly about the care provided, when in actuality that organization has to "defend how the medical record works."

No, in reality they (rightly) have to defend their decisions to acquire, implement, and fail to remediate bad health IT that produces crap outputs.

More on evidentiary issues below. First, an aside.  It seems to me - if one wants to speak about liability, aside from medical malpractice - that there's significant grounds for product liability lawsuits regarding these IT systems being unfit for purpose, as well as corporate liability for failure of officers with a fiduciary responsibility to perform due diligence on these critical medical records apparatuses.
  
Further, if the printouts are bad compared to the screens, then it seems incumbent on hospitals to produce for legal and clinical purposes the actual screens.  Ultra-clear screenshots can be accomplished with ordinary off-the-shelf cellphones and no special conditions, as in the example I just took, unaltered, of the screen I am composing this essay on:


Cellphone screenshot: Click to enlarge





Let's get down to the real problems with EHRs and evidentiary issues. 

It's not "certain plaintiffs' lawyers – a kind of group of them who communicate with each other –  seeing the medical record as an opportunity for litigation."

It's negligent and opportunistic EHR vendors, complacent hospital officers, and a legislative and justice system that needs education as to clinical and evidentiary problems caused by the prior two groups.

Here's more on the true problems:

Electronic medical records (EMRs or EHR, for electronic health record) came about as a result of a belief by pioneers in the field of Medical Informatics at organizations such as Harvard, the University of Utah, and others, as early as the 1950’s, that computers could streamline storage and retrieval of needed medical information, help standardize the language used in medical record-keeping (thus helping the accuracy and portability of records), provide automated computer-generated alerts and reminders, and solve the issue of illegible handwriting.
  
The term “EMR” itself is an anachronism.  EMR systems today are no longer just electronic filing systems replacing the paper chart, as they were early in their development. They are now integrated systems for order entry, results reporting, alerts and reminders, etc. They are now, in effect, enterprise clinical resource “nervous systems” for control of the clinical activities of a hospital or clinic.  All transactions related to care must increasingly pass through EMR systems as an intermediary between clinicians and patients.  The records of such transactions are increasingly only in electronic form.

Importantly, EMR technology is not regulated in any meaningful way, as is IT in other sectors, such as the pharmaceutical industry (where the FDA provides regulation of quality and security of systems used to store and manipulate clinical trial data and drug manufacturing), the aviation industry (where the FAA regulates safety and testing to assure freedom from potentially catastrophic malfunctions), and other mission critical sectors of industry.   


There is no regulatory pre-market or postmarket surveillance of EMR systems in place regarding reliability, safety, information security and other areas as there is in other healthcare sectors, and efforts to have such regulation initiated by the FDA and others have been resisted by the health IT industry. 

Some examples of EMR hazards can be found in the article “E-Health Hazards: Provider Liability and Electronic Health Record Systems” by attorney Sharona Hoffman & engineer Andrew Podgurski, Case Western University (freely available at http://scholarship.law.berkeley.edu/cgi/viewcontent.cgi?article=1813&context=btlj).
  
Without regulation of EMRs, critical issues have been neglected, such as the optimal presentation and understandability by doctors and nurses of EMR outputs (often created using templates, checklists, menus etc. of various kinds) and of the need for assurance that information in EMR systems is complete unaltered, and trustworthy.  

Critically, the electronic record is a malleable and ephemeral record of events, backed up by an equally malleable and ephemeral electronic audit trail, both under the sole control of a defendant hospital or clinic. 

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

The largest problem I've seen in Discovery is hospital and defense resistance towards production of the one item in electronic records that can allay legitimate concerns about withholding or alteration (and I say "can" because the industry has also been negligent in audit trail implementation and security): the audit trail.

An audit trail (sometimes called an audit log) is an automatically generated accounting of who accessed an electronic record, when, and the actions they took, such as document creation, alteration or deletion. 

An audit trail is the only way to authenticate electronic medical records as complete, free from alteration, and trustworthy.  An audit trail is akin to a banking statement, but instead of tracking monetary deposits, withdrawals and other financial changes, it tracks deposits, withdrawals and changes to clinical medical information. Without an audit log, the record is not authenticatable as complete and free from alteration.  Absence of an audit log would leave the electronic medical record subject to undetectable tampering or selective information withholding.  Its production is essential for evidentiary purposes, without exception.


Audit logs track changes within a record chronologically by capturing data elements, such as date, time, and user stamps, for each update to an EHR. An audit log can be used to analyze historical patterns that can identify data inconsistencies.


EMRs are vulnerable to manipulation. Electronic data are not tangible. Electronic data are invisible bits of data on some electronic storage media such as magnetic disk. As such, data can be manipulated on that media.  Detection of omissions, erasures, and alterations that would characterize tampering with paper records is not available with printouts of electronic medical records. The audit trail replaces those visual cues. 


The only way to tell if electronic records have been altered or partially withheld is via an electronic audit trail that can track creation of, and changes to, the record content.


Literature supports the necessity of reviewing an audit trail to ensure a complete medical record. 


From "ELECTRONIC HEALTH RECORDS SYSTEMS: TESTING THE LIMITS OF DIGITAL RECORDS’ RELIABILITY AND TRUST", Drury, Gelzer, and Patricia Trites, Ave Maria Law Review, Summer 2014, pg. 263, free at http://lr.avemarialaw.edu/Content/articles/v12i2.Gelzer.pdf:


... EHRs can be designed, configured, implemented, and used to render false representations in the course of “regular business.” This, then, is a principal distinguishing aspect of EHRs that tests the boundaries of current evidentiary procedures that presume their reliability and trustworthiness is no worse than other records management systems. In their current unregulated, non-standardized states where the current primary market drivers of their use exclude prior inspection against long-standing records management requirements, they illustrate the necessity of scrutiny of all outputs produced for rendering into legal proceedings. This necessity arises not simply from substantial possibility of legally dubious record management processes, but also the possibility that reliability supports, such as audit trails and near and long-term records management functions, may themselves be missing, difficult to use, or of uncertain veracity as verified by the OIG [Dept. of Health and Human Services, Office of Inspector General] survey. 

(See my Dec. 10, 2013 post "44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like" at http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html for more on the latter point and the referenced OIG report.)

In summary, it sounds like HIMSS attendees are going to hear a misdirecting presentation from, what appears to me, apologists for gross EHR defects due to industry and hospital negligence, with the blame being shifted to a patient's only hope for fair addressing of malpractice - the Plaintiff's Bar.

I consider this disappointing.

Finally, not all counsel on the defense side take anti patient-rights stances on these matters.  While I don't agree with everything in it, and have some points of significant disagreement, I've found the 2014 book "Electronic Medical Records and Litigation" by attorney Matthew Keris of defense firm Marshall Dennehey Warner Coleman Goggin useful.  I think there's realistic acknowledgement in the book of the ill effects of bad health IT, without internecine barrister-barrister attacks.

Finally, I am an independent expert witness in healthcare informatics, meaning I will work with defense when the facts and evidence merit.  In my presentations to lawyers, I include slides geared to defense.  In part these slides advise defense counsel that through their efforts in advising their clients, they hold the key, through advice rendered, to the prevention of bad health IT from ever seeing the light of day in hospitals, and thus from causing or contributing to medical malpractice, patient harm and death, and evidentiary mayhem.

I wish more of that advice-giving would occur.

-- SS

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