Friday, 8 May 2015

DaVita Settles Another Lawsuit Amidst Accusations of "Managing Witnesses to Provide False Testimony," After Justice Department Lost Interest in Participating

DaVita Settles Another Lawsuit Amidst Accusations of "Managing Witnesses to Provide False Testimony," After Justice Department Lost Interest in Participating

The Latest Case

Less than a year since its last big settlement (look here), DaVita HealthCare Partners, the big for-profit dialysis provider, has to settle again.  The basics, according to the Denver Post, were:


DaVita HealthCare Partners said Monday it will pay up to $495 million to settle a whistle-blower lawsuit accusing the Denver company of defrauding the federal Medicare program of millions of dollars. 

The company, which said it does not admit any wrongdoing, has now settled its third whistle-blower lawsuit since 2012, with payouts totaling nearly $1 billion.

The civil suit, filed in Atlanta in 2011, revolves around a claim by Dr. Alon J. Vainer and nurse Daniel D. Barbir, who both worked for DaVita. They noticed that DaVita was throwing out good medicine that it then billed Medicare and Medicaid for, according to the lawsuit.

The details of the allegations about how the government was defrauded were:


The lawsuit cited DaVita's inefficient use and costly waste of the drugs Zemplar, or vitamin D, and Venofer, an iron supplement. If a patient, for example, needed 25 milligrams of Venofer, the physician would use that much and toss the rest of the 100 mg vial. Medicare would be billed for the 100 mg.

In other instances, if a patient needed 8 mg of Zemplar, DaVita doctors were instructed to a use a 10 mg vial, instead of four 2 mg vials.

According to the lawsuit, the National Centers for Disease Control and Prevention recommended against allowing multiple uses of the same vial in 2001, based on infection outbreaks caused by the re-entry of another drug, Epogen. But a year later, CDC changed its policy and allowed re-entry of single-use vials Epogen, Zemplar and Venofer if procedures were followed.

DaVita did not do this but 'should have,' according to the lawsuit, 'but they (DaVita) intentionally did not do so in order to purposefully create and maximize their waste and receive significantly higher reimbursements and revenue for Venofer and Zemplar usage.'

The US Department of Justice did not seem interested.

The case began as a sealed lawsuit filed with the federal government in 2007. But, after two years of investigating, the government decided not to join the lawsuit, according to The New York Times.


As is de rigeur in such cases, a company spokesperson proclaimed that the company only settled to avoid the expense and uncertainty of a trial,

'Although we believe strongly in the merits of our case, we decided it was in our stakeholders' best interests to resolve it,' DaVita's chief legal officer Kim Rivera said in a statement Monday. 'The potential mandatory penalties for being found in the wrong in even a small percentage of instances were simply too large.'

As best as I can tell, the penalties were only monetary, and accrued only to the company as a whole, not to any individuals who authorized, directed, or implemented the alleged misbehavior.

Meanwhile, as reported by Forbes this week,  DaVita CEO Kent Thiry's most recent yearly compensation was $17,099,257, and he continues to feel comfortable pontificating

'They don’t care how much you know,' he tells FORBES, 'until they know how much you care.'

The Forbes piece's timing may have not been coincidental, perhaps designed to put a smiling face on the company after yet more evidence of ethical problems.  If only Mr Thiry would show how much he cares about the ethics of his company's operations.

The company's integrity is particularly an issue since vulnerable patients entrust it with their care.  For example, the company's kidney care division claims it cares for 174,000 dialysis patients.  

However, there is still more to the story.


DaVita's Past Record 

We have often noted that big health care organizations get relatively lenient treatment from law enforcement compared to, say, small time Medicare and Medicaid fraudsters (e.g., look here.)  In this case, law enforcement was not just lenient.  The government law enforcers simply stepped away from the case, leaving it to proceed privately.  

What makes this particularly striking is DaVita's past record.  The Denver Post article included,


Since the case was filed, DaVita has settled on two other lawsuits brought on by whistle-blowers. In 2012, DaVita agreed to pay $55 million to the federal government and others over fraud claims that it medically overused and double-billed the government for Epogen, an anemia drug. The suit was filed by Ivey Woodard, a former employee of Epogen-maker Amgen, in 2002.

In October, the company paid $389 million to settle criminal and civil investigations into whether DaVita offered kickbacks to kidney doctors for patient referrals. David Barbetta, a DaVita senior financial analyst, filed the suit in 2009. The company in January paid an additional $22 million to settle related claims by five states, including Colorado

In fact, as we noted in a post last year, Gambro Inc, a company with which DaVita had a joint venture, and which was later acquired by DaVita, made multiple settlements, of alleged kickbacks and health care fraud, from 2000 - 2004.  And the proposed acquisition by DaVita of Gambro provoked charges by the Federal Trade Commission of anti-competitive practices.  

The federal authorities ought to have known about at least the 2000 - 2005 settlements and allegations, and the case filed in 2002 that was settled in 2012, at the time it decided not to pursue the current case.  So their conduct here seemed even more lenient than usual.

Questions of Witness Manipulation

Despite the company's protestations that it settled as a matter of expediency, there is reason to think there might have been other motivation.  A blog post on Reuters by Alison Frankel stated

[Plaintiffs' attorneys] Wood, Wilbanks and their team persuaded the judge overseeing the case, U.S. District Judge Charles Pannell of Atlanta, that DaVita had orchestrated what Judge Pannell called 'a disturbing pattern of alterations in witness testimony.'

At the time the case settled, the judge was contemplating a motion by the whistleblowers to lift attorney-client privilege under the crime-fraud exception. Even DaVita, in a post-hearing brief filed on March 31, conceded that 'regrettable mistakes have been made in this case.'

Those mistakes began to emerge in November 2013, when Wood and the other whistleblower lawyers filed a motion for sanctions against DaVita. They claimed, among many other things, that the witness DaVita designated as its expert on a computerized dosage system gave false testimony at his deposition in October 2012 and only admitted his mistakes when plaintiffs’ lawyers confronted him with contradictions a year later. According to the sanctions motion, DaVita’s lawyers also improperly coached witnesses to change their deposition testimony about the dosage system. DaVita responded that its expert witness had corrected his testimony as soon as he realized his mistake, long before plaintiffs threatened sanctions. The company called the plaintiffs’ coaching and conspiracy theories 'facially incredible and a complete fiction.'

Nevertheless, after discovery that Judge Pannell called 'a series of protracted fights resulting in furious rounds of briefing, hearings, and accusations' and a three-day hearing before the judge in July 2014, Pannell concluded the evidence of forgetfulness and changed testimony from several witnesses was 'highly suspect.' At best, he said, DaVita tacitly led the whistleblower lawyers astray by letting erroneous testimony from its computer expert stand for a year.

At worst, Pannell wrote, 'the defendants purposely manipulated the evidence and witnesses to hide the truth from the (plaintiffs) and the court.' He ordered discovery to be reopened and instructed DaVita to pay plaintiffs’ lawyers their fees and costs for the sanctions litigation and the newly ordered discovery.
DaVita’s troubles still weren’t over, however. According to a November 2014 motion by the whistleblowers’ lawyers, a former DaVita clinical services specialist admitted in a post-sanctions deposition that she lied under oath at one of her previous depositions. She said she couldn’t say why without revealing privileged communications, which prompted plaintiffs’ lawyers to ask Judge Pannell to lift the privilege. 'DaVita’s scheme of managing witnesses to provide false testimony,' they wrote, 'will now collapse like a house of cards.'

The judge was sufficiently concerned to order an in camera review of communications between DaVita lawyers and three DaVita witnesses who changed their deposition testimony about the computer dosage system through errata filings or cited privilege in refusing to answer questions about it. He also held four days of hearings on the whistleblowers’ crime-fraud motion, including in camera testimony from those three witnesses and from two DaVita defense lawyers.

So the judge in this case thought there were serious suspicions that DaVita lawyers manipulated witnesses.  If true, this would be a whole other order of unethical behavior. Yet again this case was not considered big enough to become a "federal case."

Summary

So yet again we see a large health care company settling a lawsuit that alleged unethical acts, and in this case, generated further allegations of unethical acts during the litigation itself.  The settlement was for what seemed a lot of money, but actually little money compared to the corporation's revenues.  The settlement did not take into account previous legal and ethical allegations against the company.  The settlement did not involve any negative consequences for any individual who might have authorized, directed or implemented any of the apparent bad behavior.

We have seen such settlements again and again in the US health care sphere, and indeed in other spheres, such as finance.  They appear, as I have said before, to be part of a larger, mannered Kabuki play, in which rituals are performed to show some symbolic acceptance of ethics and morality, but without any true deterrent effect on bad behavior.

Perhaps the origin of the script was in some neoliberal fantasy that big corporations and their leaders ought to be exempt from even slightly harsh justice because of their economic importance, e.g., that they are Too Big to Jail.  A recent review of the book "Too Big to Jail" in the Washington Monthly noted that Mr Eric Holder, the current US Attorney General has urged leniency for big, and hence economically powerful corporations,


a memo written by Holder in 1999, during his stint as deputy U.S. attorney general. The document, 'Bringing Criminal Charges Against Corporations,' urged prosecutors to take into account 'collateral consequences' when pursuing cases against companies, lest they topple and take the economy down with them. Holder also raised the possibility of deferring prosecution against corporations in an effort to spur greater cooperation and reforms—a policy, unsurprisingly, later supported by the Bush administration.

The attorney general angered many last year when he reiterated those concerns at a congressional hearing, admitting 'that the size of some of these institutions becomes so large that it does become difficult for us to prosecute' because of the potential nasty economic effects of a major company failure.

Relieving large corporations and their leaders from the need to follow the law is a recipe for impunity, if not oligarch, and goes against the fundamental spirit of the US Constitution.  But, hey, who's counting?

The impunity of large corporations and their leaders has become so routine as not to even be news anymore.  I cannot find any coverage of the current DaVita settlement so far beyond a few regional news outlets, and one business wire service.  The national media and as been as blase as was the Justice Department.  A short version of the story, similar to that in the Denver Post, did appear in a nephrology news service, but I saw nothing in the national medical news media.  Legal settlements like this remain relatively anechoic

So yet another marcher in the parade of legal settlements could inspire boredom.  However, the cumulative procession of demonstrations that neither the US government, the news media, the medical and health care literature, nor any medical societies, patient advocacy groups, accrediting organizations, health care foundations and the like seem to care about continuing, repeated unethical behavior by large health care organizations should chill the hearts of patients and health care professionals.  If we do not stand up for ethical, honest health care, what kind of swamp will health care become?

As I have said again, again, again,...  Leadership that cares not for honesty, transparency, or accountability, and that puts short term revenue, and usually personal enrichment ahead of patients' and the public's health may be the single most important reason that US health care is so dysfunctional.  Yet hardly anyone even dares discuss the damning facts about health care leadership, much less propose solutions.  If we do not reform our health care leadership so that it is transparent, honest, accountable, unconflicted, and it puts patients' and the public's health over personal enrichment, our health care system will continue to founder.  

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Thursday, 7 May 2015

Health IT - How Did Things Get So Bad?  Look to Late 20th Century Recruiters and "The School of Hard Knocks" Leaders They Preferred

Health IT - How Did Things Get So Bad? Look to Late 20th Century Recruiters and "The School of Hard Knocks" Leaders They Preferred

I have a long memory, unfortunately for health IT opportunists and hyper-enthusiasts.

After reading letters and reports such as:


One might ask the question:

"How did things get so bad?"

I believe one needs to look to the culture of medicine and to the culture of IT, specifically, the culture of IT recruiting in medicine by exclusive retained recruiters hired by hospitals to secure IT leadership (the predominant model used, with the contractual agreement that jobs will only be filled through the recruiter). 

The culture of medicine is one of demanding education and proof through repeated testing and licensure that some fundamental level of competence exists.  This cultire arose, in part, as a result of the Flexner Report of 1910 (http://www.medicinenet.com/script/main/art.asp?articlekey=8795) that called out abuses in medical education and practice where anyone from the "school of hard knocks" could call themself a physician and hang a shingle, with disastrous results:

... The Flexner Report triggered much-needed reforms in the standards, organization, and curriculum of North American medical schools. At the time of the Report, many medical schools were proprietary schools operated more for profit than for education. Flexner criticized these schools as a loose and lax apprenticeship system that lacked defined standards or goals beyond the generation of financial gain. In their stead Flexner proposed medical schools in the German tradition of strong biomedical sciences together with hands-on clinical training. The Flexner Report caused many medical schools to close down and most of the remaining schools were reformed to conform to the Flexnerian model.

The culture of health IT recruiting?  Perverse.

Having posted many times on the issue of "expertise not needed" relative to HIT, the mother of all statements on health IT talent management has to be this from the major HIT recruiters of the late 20th century.

From the article "Who's Growing CIOs?" in the journal “Healthcare Informatics", November 1, 1998, see http://www.healthcare-informatics.com/article/who-s-growing-cios?page=3:

... In seeking out CIO talent, recruiter Lion Goodman doesn’t think clinical experience yields IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs, according to Goodman. "They don’t think of the business issues at hand because they’re consumed with patient care issues." ... Instead of healthcare organizations looking just outside their IT divisions to recruit IT management, Goodman advises, "Look for someone who has experience outside healthcare as well as inside healthcare," in particular people with IT experience from industries such as banking and manufacturing, which use more advanced information system technology.

When I first saw this in 1998, I was stunned by its abject stupidity and feared for the future implications.  My fears in 2015 are now realized, in spades.

Lion Goodman was an idiot, and a dangerous idiot at that in my opinion.  "Patient care issues" ARE the business of hospitals.

Experience in banking and manufacturing IT is not helpful because medicine is not a mercantile or banking activity.  Also, "advanced technology" was not the issue as today's usability, interoperability, crashes and other failures demonstrate.  Banking and manufacturing IT personnel understood the more critical issues of human factors engineering supporting healthcare provision like a fish understood nuclear physics.

More importantly, medicine is far different and in fact the IT culture in those environments is anathema to the flexibility and understanding of the poorly bounded, high tempo, high risk practice of medicine (see "Hiding in Plain Sight", Nemeth & Cook, http://www.researchgate.net/publication/7738740_Hiding_in_plain_sight_what_Koppel_et_al._tell_us_about_healthcare_IT, click on "full text" image on right).

That health IT is now nearly universally reviled by physicians and nurses and is harming and killing people and even bankrupting healthcare systems trying to fix 10,000 bugs (e.g., "In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red", http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html) is a predictable outcome of hiring patterns for today's health IT leaders that resulted from such a perverse and ignorant talent management ideology.

Even worse, in the same article from Goodman and another major IT recruiter of the day with whom I was very familiar is this gem:

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks."

Ms. Goodman and Ms. Hersher must have been transported to the late 20th century from the Dark Ages.

Oh wait ... even Medieval monks in monasteries believed in the value of scholarship.

These attitudes are completely alien to medicine, and for good reason.  The damage done to health IT by the hiring practices of the past is incalculable, but likely considerable.  I was shocked even then by the qualifications and abilities of the health IT leaders I encountered, most of whom I had to clean up after, one way or another in order to protect patients from their abject medical recklessness and ignorance (e.g., http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU , and http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story as just two examples).

One wonders just how many "from the school of hard knocks" HIT leaders were pushed by these recruiters onto healthcare organizations, and the harm such leadership may have done to healthcare, healthcare IT, and to patients in the intervening years.

Such an ideology widened the pool of candidates and likely increased the recruiter's profits ... the ultimate in parasitism considering, in 2015, the waste of hundreds of billions of dollars on terrible technology, reviled by most users and causing harm, in part due to being designed and implemented by leaders from "the school of hard knocks."

-- SS
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Politico: Electronic record errors growing issue in lawsuits

Politico: Electronic record errors growing issue in lawsuits

The indefatigable Arthur Allen of Politico.com has authored a nice piece on the issue of EHRs being a cause of medical malpractice, with resultant litigation.  I was a contributor:

Electronic record errors growing issue in lawsuits
By Arthur Allen
5/4/15 6:40 AM EDT
http://www.politico.com/story/2015/05/electronic-record-errors-growing-issue-in-lawsuits-117591.html

Medical errors that can be traced to the automation of the U.S. health care system are increasingly an issue in medical malpractice lawsuits.

Some of the doctors, attorneys and health IT experts involved in the litigation fear that safety and data integrity problems could undercut the benefits of electronic health records unless HHS and Congress address them aggressively.

I already believe the benefits of EHR technology have been severely undercut - if not destroyed - by the unbelievably poor quality, user experience and incompetent implementations presented by most commercial health IT software today.

I even have a dead mother to offer as evidence, due to an ED EHR's lack of fundamental and crucial confirmation dialogs and notification messages to team members.  These computer science-101 level deficiencies permitted a triage nurse's failure to successfully click a heart medication for continuation to propagate through several days of ICU/floor hospitalization unnoticed.  Gross overconfidence in computer output and cavalier attitudes in the ICU about med reconciliation sealed the deal, where, recognizing something seemed amiss with the meds list vs. the history of arrhythmia, the ICU doctor did nothing except leave a question in the chart about it, resulting in catastrophe.

“This is kind of like the car industry in Detroit in 1965,” says physician Michael Victoroff, a liability expert and a critic of the federal program encouraging providers to adopt EHRs. “We’re making gigantic, horrendous, unsafe machines with no seat belts, and they are selling like hot cakes. But there’s no Ralph Nader saying, ‘Really?’”

There are, actually, but an "Unsafe at any MHz" has not yet been written and taken seriously by the public about EHRs.  The industry has been too in control of the narrative for that to happen.

According to a review by The Doctors Company, the largest physician-owned U.S. medical malpractice insurer, EHR issues were involved in only 1 percent of a sample of lawsuits concluded from 2007 through 2013. But that finding could be deceptive since it takes five or six years to close a suit, and during that period the numbers of such cases grew rapidly as electronic health records become more pervasive in hospitals and physician offices. The pace of these cases doubled from 2013 to early 2014.

At the linked report at http://www.thedoctors.com/KnowledgeCenter/Publications/TheDoctorsAdvocate/CON_ID_006908 the med mal insurer "The Doctor's Company" noted:

... Shortly after electronic health records (EHRs) began to be widely adopted, The Doctors Company and other medical professional liability insurers became aware of their potential liability risks. We anticipated that EHRs would become a contributing factor in medical liability claims. Due to the three- to four-year lag time between an adverse event and a claim being filed, however, EHR-related claims have only recently begun to appear. In 2013, we began coding closed claims using 15 EHR contributing factor codes (eight for system factors and seven for user factors) developed by CRICO Strategies for its Comprehensive Risk Intelligence Tool (CRIT).

In 2013, The Doctors Company closed 28 claims in which the EHR was a contributing factor, and we closed another 26 claims in the first two quarters of 2014. During a pilot study to evaluate CRICO’s EHR codes, 43 additional claims closed by The Doctors Company were identified (22 from 2012, 19 from 2011, and 2 from 2007–2010).

What is not stated is the fact that many EHR-related harms are not recognized as such; many injured patients do not sue, and many who want to cannot do so due to the expense and time involved for plaintiff's attorneys (I have heard the figure that perhaps 5% do make it to suit).  Along with the time lag noted, these figures are another Red Flag, as are the ECRI Deep Dive harm figures, representing what is likely just the "tip of the iceberg."

(See "Peering Underneath the Iceberg's Water Level" at  http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html and "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths, Probably Just 'Tip of Iceberg'" at http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html).

Back to Politico:

The lawsuits allege a broad range of mistakes and information gaps — typos that lead to medication errors; voice-recognition software that drops key words; doctors’ reliance on old or incorrect records; and nurses’ misinterpretation of drop-down menus, with errors inserted as a result in reports on patient status.

In addition, discrepancies between what doctors and nurses see on their computer screens and the printouts of electronic records that plaintiffs bring to court are leading some judges and juries to discredit provider testimony and hand out big awards. In one case, a patient in septic shock had suffered gangrene and a severe skin rash, but computer records read “skin normal.” They also showed repeated physician interviews with the patient — when she was comatose.

I can verify both of these issues personally, from my legal work - not to mention outright electronic record tampering.

... While the percentage of EHR-related cases is still low, “this is going to become a bigger and bigger issue,” said David Troxel, medical director of The Doctors Company. “I get more calls from frustrated, angry doctors about their EHRs than any other subject.”

Doctors may be following my advice (see end of my post at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html) where I wrote:

... 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 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.)
Back to Politico:

The industry “takes very seriously the need to enhance the well-documented ability of EHRs to increase patient safety,” an association spokesperson said. “It also recognizes the importance of looking for opportunities to identify and reduce any potential risks associated with development and use of EHRs. All these efforts are essential to the goal of learning more about the ways in which technology, training and configuration can be rolled out in the safest possible ways.”

This is pure B.S. and spin.  There is no "well-documented ability of EHRs to increase patient safety", just a number of methodologically flawed/biased studies (like this one, http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html), a lot of pro-HIT rhetoric, and a lot of harms data that the industry ignored for many years.

The statement also ignores what the domain expert end users - physicians and nurses - themselves are saying, see "Accenture - Fewer U.S. Doctors Believe IT Improves Health Outcomes (April 2015)" at http://www.businesswire.com/news/home/20150413005148/en/Increased-Electronic-Medical-Records-U.S.-Doctors-Improves#.VT5bmpOTqUk.

Why, one should ask as well, should an industry that's been around for decades only now be "learning more about the ways in which technology, training and configuration can be rolled out in the safest possible ways?"  

I see that statement as an industry self-condemnation of years of cavalier IT practice. 

... But providers and health care systems are eventually going to start suing vendors, analysts said, in part because software companies are viewed as having deep pockets. “It’s only a matter of time before a company like athenahealth or Allscripts or Epic or Cerner gets sued,” said Klein.

Plaintiffs’ attorneys are already eyeing such cases, according to Scot Silverstein, a Drexel University health IT expert and internist who is suing a hospital over a lapse in care of his mother that Silverstein claims was caused by poor EHR implementation. Silverstein and two plaintiff’s attorneys met with Rep. Matthew Cartwright (D-Pa.) and other lawmakers in November to plead for more government regulation of EHRs.

I was actually more direct with the author of the article, Mr. Allen.  I said that the sellers of these systems deserved to be sued - that they had earned it through slovenly practices in thought and application enabled by the extraordinary regulatory accommodations afforded to and protected by the industry since its inception (i.e., no regulation) - when system flaws result in patient harm. 

... Some recent studies show that EHRs do make hospitals safer. But the data isn’t conclusive, said William Marella, executive director of the ECRI Institute Patient Safety Organization. Last year, ECRI convened a partnership of EHR vendors, safety experts, academics and medical groups to share and analyze health IT problems ... EHR safety issues are frequently misdiagnosed — and thus under-diagnosed — by providers, according to ECRI’s Marella. “They say, ‘wrong site surgery,’ or ‘drug error,’ which can make it hard to ferret out the cases where IT is responsible.”

It is absurd and disingenuous to speak of 'safety improvements' when the true harms rates are admittedly unknown (see "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html) for more on that issue.

... In about 200 EHR-related legal cases that the liability firm CRICO analyzed, the glitches rarely led directly to patient harm, said Dana Siegal, the company’s director of patient safety services. But she added, “We’re seeing failures to communicate or providers acting on inaccurate information that was driven in part by an EHR issue.”

This brings up another issue.  Computers don't pull triggers and the mayhem they cause doesn't usually immediately kill people.  My mother, for example, survived the initial EHR-led assault on her life, though her survival required emergency reversal of anticoagulation in the face of critical carotid stenosis that had already caused a TIA, emergency craniotomy (brain surgery), and other risky interventions.  She died a year later of complications of her injuries.  Her case would not be likely to be counted as an "EHR-related death" in any statistics (if it was reported at all).  This "time delay" would likely cause any statistics on EHR-related deaths to be understated on their face.

... While the effect of EHRs on malpractice suits is still modest, many analysts worry about the overall uncertainty concerning information in such systems. Confusing or inaccurate records, if they proliferate, not only cast doubt on a doctor in court but could taint clinical research that draws on these large pools of data.

Bravo to Arthur Allen for pointing out that clinical research that draws on garbage, uncontrolled data will turn out garbage.  See my paper "The Syndrome of Inappropriate Overconfidence in Computing" at http://www.jpands.org/vol14no2/silverstein.pdf for more on that issue where I observed:

... This increasing confidence in EHR data to perform far more complex tasks than postmarketing surveillance of a single drug is of great concern. Prompt detection of adverse drug events (ADEs) from single drugs, using aggregated EHR data, is within the realm of possibility. Detection of relatively more nebulous (i.e., compared to major ADE) “outcomes differences” between two or more drugs or treatments via EHR data—such as, did treatment A lower blood pressure more than drug B, or did drug C lessen depression more than drug D—rises to the level of “grand overconfidence in computing” and perhaps “grand folly.”

To accomplish this task with reasonable scientific certainty from aggregated EHR data originating from different vendor systems, input by myriad people of different backgrounds, with differing interpretations of terminologies (students/residents/attending
MDs/RNs etc), under different pressures and motivators (time limits, cognitive overload from poor HIT user interfaces, reimbursement maximization, and so forth), seems improbable.

What levels of statistical validity could arise from such studies? Could they even approach the level deemed “acceptable” in good science?We do not know, although I suspect a “garbage in, garbage out” (GIGO) phenomenon, leading to studies whose results are more likely related to chance than to solid reality.

Back to Politico:
A recent report by the HHS Office of Inspector General said the department has failed to assure that EHR data are secure and accurate. Many hospitals have unsecured audit trails—meaning that information in the record could be altered without detection, it said.

This ability - to alter records - has been admitted under oath by EHR systems administrators in cases in which I have been an advisor to the Plaintiffs' attorney - and had the questions asked.  Hospitals have possession and control of easily-alterable information (far easier than paper) that is the only evidence of potential misadventures - a major conflict of interest.

... “There’s really no one with a vested interest in the integrity of the record besides you, the patient,” said Reed Gelzer, a physician and health IT expert.

Yes, but getting it can cost thousands of dollars.  I paid about one thousand dollars for a few reams of printed EHRs, and this is not uncommon.

... Concerns led the Institute of Medicine in 2011 to propose the creation of a dedicated IT safety center with the power to investigate EHR risks. ONC has since settled on a center that would have no investigatory power but would provide a safe environment in which real-life problems could be analyzed and solutions developed.

In other words, ONC has settled on a joke, on tension management.

The safety center is a “critical priority right now for ensuring the transformation from a world of paper to a world of electronics and connectedness,” said Patricia McGaffigan, COO and a senior vice president at the National Patient Safety Foundation.

Yes, a powerless, industry-friendly "safety center" is a priority for good reason.  Not to sound mean-spirited, but if the wife, child, parent of one of the proponents of a milquetoast "Safety Center" suffers EHR-related injury and dies a painful and lingering death as a result, as did my mother, the proponent will get little sympathy from me.   They've certainly tempted the Gods.

I will leave the final word to physician Michael Victoroff:

“The vendors are very right that if they had true product liability they wouldn’t make these things,” he said.

To which I say to the Information Technology vendors, if you can't take the heat (of accountability in medicine), then get the hell out of our medical kitchen.

-- SS
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Wednesday, 6 May 2015

Another day, another EHR outage:  MEDSTAR EHR goes dark for days

Another day, another EHR outage: MEDSTAR EHR goes dark for days

At my March 2, 2015 post "Rideout Hospital, California: CEO Pinocchio on quality of patient care during hospital computer crash" (http://hcrenewal.blogspot.com/2015/03/rideout-hospital-california-ceo.html) I highlighted a stunning example of when the light shone through the corporate B.S. about health IT outages, thanks to a letter to the editor by a family member of an affected patient:

Letter: Re: Rideout Hospital computer problems

http://www.appeal-democrat.com/opinion/letter-re-rideout-computer-problems/article_4a408cc0-be47-11e4-9b7b-93c22da930d4.html 

Friday, February 27, 2015 

I am writing in regard to comments made by the CEO of Rideout Hospital regarding its recent computer crash. 

He said quality of care for patients had not been compromised during this incident. He is lying.

My spouse went to Rideout almost two weeks ago and had a Lexiscan of her heart when the computer system went down. The hospital doctor released her and assured her that if anything were wrong, the radiology department would spot it and she would inform us.

Here it is two weeks later and now they are saying because of the computer problem the entire test didn't get to her cardiologist until today. They think she may have had a minor heart attack and needs further cardiac intervention.

 Is this the new "open and improved" truths we are getting from this hospital? Rideout CEO Robert Chason misinformed us all. 

I am sure my spouse, who has fallen through the cracks during this inexcusable lapse in Rideout's technical policies, is not the only patient suffering similar situations. 

Shame on Chason for minimizing the effects of this catastrophe at our local hospital. 

Edward Ferreira 
Yuba City

I am aware of another major EHR outage via Politico.com:

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.

I do not know if corporate issued the standard "patient safety was not compromised" line, but can almost predict it was uttered somewhere along the line.

MedStar is a big healthcare system.  An outage for several days at its outpatient clinics is disruptive and will lead to harms in the short term, but also in the long term, that cannot be effectively tallied, due to lost information. 

That includes information put on backup paper that fails to get entered when an EHR goes back up, as well as outright computer data loss as occurred here.

Note the doctor's comments about the "liberating" aspect of being freed from health IT.  He/she could actually practice medicine, not computer babysitting.

How many harms will come of this "major malfunction?"  There is no way to know.  However, hospitals cannot have it both ways.  If these systems are touted as improving safety, then safety is affected when they are down and emergency measures are put into place, resulting in chaos; and certainly when information simply goes to the "bit bucket."

The answer?  Either far more redundancy, or far less reliance on "paperless" systems.

There also needs to be mandatory reporting of EHR outages and root cause analysis so the incidence and the reasons can be studied, at the very least.

-- SS
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MBA-holding Informatics Fellow's Portfolio: Revolutionizing Healthcare Through Plagiarism

I highlighted the MBA culture at least once before on this site, on April 16, 2010 at "Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'", http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html.

In that post, I noted MBA candidates/Cerner employees happily conspiring in a paper at Duke's Fuqua School of Business towards combination in restraint of trade through "recommending that Cerner collaborate with other incumbent vendors to establish high regulatory standards, effectively creating a barrier to new firm entry. "

Combination in restraint of trade: An illegal compact between two or more persons to unjustly restrict competition and monopolize commerce in goods or services by controlling their production, distribution, and price or through other unlawful means. Such combinations are prohibited by the provisions of the Sherman Anti-Trust Act and other antitrust acts.

The paper was highlighted at  professor David Ridley's page "Duke University Fuqua School of Business: Past Papers" - that is, until a few days after my blog post went up and he was informed of it.   You can see cached copies of the paper and page at the post at link above.

Today, I've had another experience with an MBA holder who has decided to enter the field of Medical Informatics.

I received an unsolicited Cc: of an email, sent by a professional in my field I do not know at a university in Australia.  The email was directed at a postdoctoral fellow at a U.S. medical informatics program in the Midwest, advising the fellow that his 'Portfolio' brag page page was plagiarized directly almost verbatim from a personal essay I'd written ca. 1999 and now archived at my current Drexel site at http://cci.drexel.edu/faculty/ssilverstein/informaticsmd/infordef1.htm, and that plagiarism was bad for informatics careers:

Date: Tue, May 5, 2015 10:28 pm
To: [Name of recipient MBA-holding informatics fellow redacted - ed.]

I was disappointed to find the following three paragraphs on the homepage of your site ([URL redacted] - ed.)

"It became apparent to me and many informatics professionals that significant confusion and misconceptions exist in hospitals, industry, and the world at large about what medical informatics is, and what experts in medical informatics do (and are able to do if given the opportunity). Also, there is confusion as to what medical informatics is not.

"The available quantity of information in most subject areas ("domains") has grown rapidly in recent decades. Issues about information and its use have become quite complex, and the issues themselves have undergone scientific study. Informatics is information science. In other words, informatics is a scientific discipline that studies information and its use.

"Both theoretical and practical issues are studied. Examples of theoretical issues include terminology, semantics (term meaning), term relationships, and information mapping (translation). Practical issues include information capture, indexing, retrieval, interpretation, and dissemination. Medical informatics, an informatics subspecialty, is the scholarly study of these information issues in the domain of biomedicine."

This text is an almost perfect copy of the introduction to Scott Silverstein’s page (http://cci.drexel.edu/faculty/ssilverstein/informaticsmd/infordef1.htm).

Plagiarism has no place in Medical Informatics, and could harm your career. I would appreciate it if you could rewrite or remove this content on your site

Best Regards 

[Professor name redacted - ed.]

There was other copied material after these paragraphs as well; almost the entire page was my words and ideas.  The page shamelessly concluded with this:

Shamelessly copied from http://cci.drexel.edu/faculty/ssilverstein/informaticsmd/infordef1.htm#importance

I do not know how the Australian professor detected the plagiarism, if he had involvement with the fellow, or the context of the interaction.

This fellow had an MBA and the title of his "portfolio" page was about his passion for 'revolutionizing healthcare.'

It's clear he thought his stealing my words and ideas would never be noticed. In other words, exploiting my creativity for his own gain and image-enhancement was fine.

Obviously in our connected world, plagiarism is not a good idea. Perhaps not so obvious are the predatory values of the MBA degree and the damaging effects on all our healthcare when such individuals 'revolutionize' it.

I sent a demand for the material's immediate removal along with a polite suggestion of unpleasantness if he does not comply.

I am not naming the postdoc due to having bigger fish to fry.

-- SS

Update 5/6/2015: 

The fellow has removed about 3/4 of my material from the webpage in question, but a passage remains verbatim.

I've sent another request backed by a screenshot and link to my material, and a rather more direct consequence of failure of complete removal.

Between the IT invasion of health IT and the MBA invasion, perhaps patients need to hire fulltime medical advocates for everything more serious then getting a boil lanced.

-- SS

Additional thought 5/7/2015:

I should add the misleading credentials exaggeration of minimal exposure to informatics (a seminar or AMIA short course at best) leading to a claim of a non-existent "American Medical Informatics Certification for Health Information Technology" by an erstwhile NextGen VP who also apparently holds a MBA with a concentration in Health Administration, see http://hcrenewal.blogspot.com/2009/02/nextgen-and-vendordoctor-dialog-yet.html.
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