Monday, 15 December 2014

Princess Health and EHRs and Ebola in the Texas Health Presbyterian Hospital ED: the ED physician finally speaks out. Princessiccia

At my Oct. 2, 2014 post "Did Electronic Medical Record-mediated problems contribute to or cause the current Dallas Ebola scare?" (http://hcrenewal.blogspot.com/2014/10/did-electronic-medical-record-mediated.html) I had written:

While I have no evidence as to any role of EHRs in this seemingly strange, cavalier and incomprehensible medical decision to send this man home, resulting in potential exposure of numerous other individuals to Ebola (and I am certainly not in a position to have such evidence), I believe this possibility [that is, an EHR-related information snafu - ed.] needs to be investigated fully.
 
I then did an update:

10/3/2014 Update:

My suspicions were apparently correct.  [The hospital admitted an EHR role - ed.]

Then, the hospital retracted its admission, blur and obfuscation broke loose in the press, and the situation became foggy.  See posts by Roy Poses and myself at query link http://hcrenewal.blogspot.com/search/label/Ebola%20virus, including Dr. Poses' Nov. 24, 2014 post "Public Relations and the Obfuscation of Management Errors - Texas Health Resources Dodges its Ebola Questions" at http://hcrenewal.blogspot.com/2014/11/public-relations-and-obfuscation-of.html.

Finally, the primary clinician involved speaks.  Do read the whole article, as it delves into behind-the-scenes issues:

ER doctor discusses role in Ebola patient�s initial misdiagnosis
By REESE DUNKLIN and STEVE THOMPSON
Dallas Morning News
Dec. 6, 2014
http://www.dallasnews.com/ebola/headlines/20141206-er-doctor-discusses-role-in-ebola-patients-initial-misdiagnosis.ece

... "[ED physician Joseph Howard Meier's] notes in the medical records say he had reviewed the nursing notes. Hospital officials told Congress that the ER physician several times accessed portions of the electronic records where the nurse had recorded Duncan�s arrival from Africa. It wasn�t clear, though, �which information the physician read,� hospital officials told Congress. 

Meier told The News he hadn�t seen the Africa notation in Duncan�s records. The physician said the hospital�s electronic medical records system contained a lot of information, which, like patients,must also be triaged.� 


Clinicians in an ED have to "triage" information from their records systems, just like patients need to be triaged?  That is a candid and astonishing (to anyone with common sense) admission.

Paper charts never had those problems in my own time working in the ED.

Further, ED charts used to be relatively brief, which is why as a Chief Medical Informatics Officer I recommended document imaging systems only in ED's, to make charts available 24/7/anywhere, and data transcriptionists to capture important data into computers later, not full EHR systems where clinicians enter data which I felt (and still feel) are inappropriate in faced-paced, high-risk settings.

(Put another way, the experiments of direct data entry by busy clinicians, and clinicians attempting to drink information from a tangled cybernetic EHR firehose, are proving a failure.)

... The �travel information was not easily visible in my standard workflow,� he said.This has now been modified very effectively.�

Modified only after near-catastrophe.  How many other "modifications" (i.e., experimental software changes) will be needed over time in this and other EHRs, I ask?  (Perhaps 10,000 such as here: http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html?)

... The News asked Meier whether knowing Duncan�s travel history would have changed his evaluation. 

�If he told me he came from Liberia, this would have prompted me to contact the CDC and begin an evaluation for Ebola,� Meier said, �but the likelihood would have still been low since Mr. Duncan denied any sick contacts.�

Over the next few hours, Meier ordered tests, along with an IV for saline. He prescribed extra-strength Tylenol, which the nurse gave Duncan at 1:24 a.m. Meier reviewed Duncan�s vital signs. CT scans of Duncan�s head were �unremarkable,� the medical records say, showing no sign of sinusitis.

Doctors typically order CT scans to rule out more serious possibilities, such as a hemorrhage or meningitis. In his responses to The News, Meier said he ordered the CT scan because of Duncan�s headache.

Meier did not say whether the CT scan�s lack of an indication of sinusitis factored into his diagnosis. �Sinusitis is mostly a clinical diagnosis,� he said.

At 3:02 a.m., Duncan�s temperature was 103 degrees, his medical records say. Sixteen minutes later, however, Meier entered a note saying: �Patient is feeling better and comfortable with going home.� Meier told The News he hadn�t seen the higher temperature in Duncan�s chart.

Duncan was discharged at 3:37 a.m. with the diagnosis of sinusitis. His last recorded fever, at 3:32 a.m., was 101.2 degrees. Meier prescribed Duncan the antibiotic Zithromax, 250-milligram tablets, to be taken twice the first day and once daily for four more days.

I note two things:

1.  If an EHR company has hiring practices allegedly such as described via Histalk blog at my Aug. 15, 2010 post "EPIC's outrageous recommendations on healthcare IT project staffing" (http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html), where rank-novice recent college graduates suddenly become EHR experts afters some transfusion of wisdom at corporate HQ (perhaps via this alien neural interface device that imparts the Knowledge of the Ancients: http://stargate.wikia.com/wiki/Repository_of_knowledge?), then what can one expect?


The Stargate neural interface device that imparts the Knowledge of the Ancients via direct brain download.  Presto - instant EHR expert!


and

2.   I note what I am going to somewhat satirically going to call the "Silverstein EHR principle", that states:

  • When bizarre and otherwise inexplicable information-related snafus occur in hospitals, especially in fast-paced, high-risk areas, suspect bad health IT as causative or contributory as #1 in your differential diagnosis (or post-mortem, as the case may be).

-- SS

Sunday, 14 December 2014

Princess Health and Yale Medicine: "Straddling medicine and journalism, a former resident keeps an eye on the science press". Princessiccia

Princess Health and Yale Medicine: "Straddling medicine and journalism, a former resident keeps an eye on the science press". Princessiccia

As a Yale medical school alumnus (post doctoral fellowship in Medical Informatics 1992-4, faculty in Medical Informatics 1994-6), I receive their literary magazine "Yale Medicine."

In the current issue I just received is a story about another Yale medical school graduate who through writing, both professionally and via blogs, is a gadfly against bad medicine - and bad media about bad medicine - like myself and the other bloggers at Healthcare Renewal, at http://yalemedicine.yale.edu/autumn2014/people/alumni/204173.

His name is Ivan Oransky, MD.

... After his internship, Oransky chose journalism over the practice of medicine. �It wasn�t the easiest for my parents to get used to, but once they saw that I was really happy and accomplishing things and adding value to the world, they got it,� he recalled. He was hired as founding editor in chief of Praxis Post, a webzine that was dubbed �Vanity Fair for doctors.� Following that, he was deputy editor of The Scientist and managing editor of Scientific American.

In 2010 Oransky started two blogs to keep tabs on the science communication ecosystem: Retraction Watch, which analyzes research corrections and retractions and which he runs with Anesthesiology News editor Adam Marcus; and Embargo Watch, a site that monitors premature news breaks and the effects embargoes have on news coverage. After four years as executive editor of Reuters Health, Oransky joined MedPage Today in July 2013.

The Yale Medicine piece is worth a read at the link above.

-- SS

Friday, 12 December 2014

Princess Health and Again, the Hospital CEO as Scrooge - Erlanger CEO and Other Top Hired Managers Get Bonuses Months After They Froze Employees' Paid Time Off. Princessiccia

Princess Health and Again, the Hospital CEO as Scrooge - Erlanger CEO and Other Top Hired Managers Get Bonuses Months After They Froze Employees' Paid Time Off. Princessiccia

Less than two weeks ago, we discussed a series of cases in which there was a marked contrast between how well top hired managers of non-profit hospitals were doing, and how their institutions were doing. 

Now another vivid example of this problem as appeared, affecting Erlanger Health System,  a non-profit hospital system in Tennessee that has recently seen hard times.

Freezing Paid Time Off

In March, 2014, as reported by the (Chattanooga, TN) Time Free Press,

Erlanger Health System's latest strategy to staunch financial losses has hit its most personal note yet, as hospital executives have decided to freeze the paid time off accruals for 4,000 employees from now until July.

Erlanger employees used the words 'defeated,' 'distressed' and 'betrayed' when describing staff reactions to the cuts, announced Friday.

The sudden decision shows just how high stakes are becoming at the Chattanooga public hospital. Erlanger is $3.8 million in the red this fiscal year and is also feeling the weight of roughly $14 million in state, federal and insurance cuts this year, hospital executives say.

At that time, hospital managers emphasized the fairness of the freeze because it would be applied across the board,

 No one -- including executive staff and doctors-- will be exempt from the freeze, which will span nine pay periods and is expected to save the hospital $5.4 million, said hospital Chief Administrative Officer Gregg Gentry.

Furthermore,

 Of all potential cuts discussed -- including layoffs -- the executive staff said the decision to temporarily freeze paid time off would have the most impact on the budget while having the 'least impact' on employees.

The result means 'everyone has to sacrifice' to make those goals, [CEO Kevin] Spiegel said.

The freeze may have so badly affected employee morale because it came on top of other changes imposed on employees,

 Erlanger has already made significant changes to employees' benefits this year -- phasing out its traditional pension plan in favor of 401(k)-like accounts; changing how paid leave is structured and approved; and increasing what retirees pay toward their health insurance.

However, there was hope that perhaps the freeze would not last long, since hospital managers had located some government money that might be obtained to relieve the deficit.

More Money, So the First Thing to Do is Give Bonuses to Top Hired Managers

By December, 2014, Erlanger finances had at least temporarily improved, partially because of access to the government money.  So, as again reported by the Times Free Press, the first thing the hospital system board did was to give bonuses to the managers who had imposed all those cuts on other employees.

At the end of a year that started with freezing employees' vacation time and warnings of financial crisis, Erlanger Health System will award $1.7 million in bonuses to its top management for financial performance.

Erlanger trustees voted Thursday to pay the incentives, which were determined by a series of benchmarks set last year. The public hospital's financial turnaround -- driven largely by a $19 million infusion of federal money -- will enable the payout averaging $17,100 to 99 managers.

Erlanger CEO Kevin Spiegel will collect $234,669 in bonus pay, bringing his total compensation this year to $914,669. Trustees also voted to give Spiegel a 10 percent raise next year, upping his base pay to $748,000, and approved a 2 percent nonbudgeted pay raise for hospital employees.

Sometimes, you just cannot make this stuff up. The CEO gets a 10% increase in base pay, and almost a quarter-million dollar bonus, while regular employees may get a 2% increase after enduring vacation time freezes, and various reductions in benefits.

Furthermore, while money was saved by supposedly across the board cuts, reducing the benefits of hard working employees, including health professionals who took direct care of patients, and revenues were increased by some relatively easily found money from the federal government, the hospital system board seemed to attribute the sudden success only to the top hired managers.

 'Management has performed exceedingly well,' said board Chairman Donnie Hutcherson, [a certified public accountant, and partner in an accounting firm] who added that the compensation is comparable to that of other hospitals such as Erlanger.  'This is well deserved. They have put in long, long hours.'

He explicitly did not seem to consider whether other Erlanger employees, especially doctors, nurses, and other health professionals also were putting in long hours, and working diligently under difficult circumstances.

 One Erlanger nurse, who asked not to be named for fear of losing her job, said the management incentives 'have come at the expense of their employees and the sacrifices they have made.'

'[Employees] have had vacation time taken away and are paying more for benefits. They are routinely overworked and understaffed,' the nurse said Friday. 'The morale among staff and doctors is the lowest I have ever witnessed. If that constitutes a bonus, obviously my belief system of what I think is morally and ethically right and wrong is not shared by the management or board members at Erlanger.'
Thus this was a strikingly bizarre use of one of the talking points that are often used to justify high and ever increasing compensation for top hired managers.  Managers are often hyped as "brilliant," and "hard working," without any explicit comparison to any other employees, especially to health care professionals who often go through much more rigorous training, and may work far longer hours than managers, administrators, bureaucrats, or executives.  (Look here)


Previous Disconnects Between Executive Compensation and Hospital Finances

In fact, discrepancies between how hired executives are treated and how the hospital system is faring financially are old hat for the Erlanger Health System.  In 2012, we noted how the board voted to give a previous CEO a golden parachute soon after the system first began running a deficit, and after unpaid work days were imposed on other employee.  After further financial deterioration, the board voted to put the severance package on hold.  However, this 2013 Times Free-Press article suggestsd that CEO ultimately received it, paid out over 15 months.  Furthermore, as we wrote in 2011, the system board did something similar in 2009, giving the CEO bonuses despite financial losses and a bond default.

This history did not seem to inform the board's current decision making, or perhaps it did inform the board that they could get away with such decisions?

Once Again, the Board Temporarily Backs Off Under Public Pressure

The Times Free-Press reported today, December 12, 2014, that once again the board has retreated,at least for a while, 

Facing criticism and questions from state lawmakers after voting to award executives $1.7 million in bonuses, Erlanger Health System officials said Thursday night they will put the payments on hold and review their actions.

Trustees for the public hospital voted Dec. 4 to approve bonuses for 99 managers, including more than $234,000 for CEO Kevin Spiegel.

The Hamilton County legislative delegation -- which appointed three trustees to the 11-member board -- harshly criticized the move, saying the hospital had not proven it could afford such bonuses after ending the last three years in the red and relying on a federal funding pool to end this year with a profit.

Whether or not the bonuses will be cancelled, reduced, or merely delayed, however, still is unclear.

 Summary

In US health care, the top managers/ administrators/ bureaucrats/ executives - whatever they should be called - continue to prosper ever more mightily as the people who actually take care of patients seem to work harder and harder for less and less. This is the health care version of the rising income inequality that the US public is starting to notice.  It seems all the more unfair in health care, since the income inequality is clearly between managers/ administrators/ bureaucrats/ executives who are mostly generic, that is, not specifically trained or experienced in health care or biomedical science, and the doctors, nurses, therapists, and technicians who actually take care of patients.  (For example, the CEO of Erlanger Health Systems, Mr Kevin Spiegel, has an MBA in Health Care Administration from Adelphi, and no obvious training or experience in actual patient care, nor biomedical science.)

As we have noted before, most recently here, the favored treatment of the managers/ etc ... is often justified by other managers on the boards of trustees who are supposed to exercise stewardship over health care organizations, and by the public relations flacks, marketers and lawyers employed by the self-same managers.  The justifications usually consist of repetitions of the same stale talking points, as if in a vacuum.  Note above that the Erlanger board member justified the bonuses by extolling the managers' performance and long hours, totally ignoring how many other hospital system employes worked hard and well to keep the system above water.

Thus, like hired managers in the larger economy, non-profit hospital managers have become "value extractors."  The opportunity to extract value has become a major driver of managerial decision making.  And this decision making is probably the major reason our health care system is so expensive and inaccessible, and why it provides such mediocre care for so much money. 


One wonders how long the people who actually do the work in health care will suffer the value extraction to continue?

So to repeat, true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty.

But this sort of reform would challenge the interests of managers who are getting very rich off the current system.  So I am afraid the US may end up going far down this final common pathway before enough people manifest enough strength to make real changes.

Princess Health and Food Reward Friday. Princessiccia

This week's lucky "winner"... Pumpkin pie!!


Read more �

Wednesday, 10 December 2014

Princess Health and The Tenth Anniversary of Health Care Renewal. Princessiccia

Princess Health and The Tenth Anniversary of Health Care Renewal. Princessiccia

Today is the tenth anniversary of Health Care Renewal.

To commemorate, I have republished our introductory post...(with links added)

Health care around the world is beset by rising costs, declining access, stagnant quality, and increasingly dissatisfied health care professionals. Discussions with physicians and other professionals revealed pervasive concerns that the core values of health care are under seige. Patients and physicians are caught in cross-fires between conflicting interests, and subject to perverse incentives. Free speech and academic freedom are threatened. Psuedo-science and anti-science are gaining ground. Causes include the increasing dominance of health care by large organizations, often lead by the ill-informed, the self-interested, and even the corrupt. (1) However, such concentration and abuse of power in health care has rarely been discussed openly. This blog is dedicated to the open discussion of health care's current dysfunction with the hopes of generating its cures.

1. Poses RM. A cautionary tale: The dysfunction of American health care. Eur J Int Med 2003; 14: 123-130.

You heard it here first.

Health Care Renewal is written by voluntary bloggers.  We have a small amount of financial support from our poor but honest non-profit, the Foundation for Integrity and Responsibility in Medicine (FIRM).  Please help us by contributing to FIRM, a US 501(c)3.  All contributions are US tax deductible as provided by US law. Our address is 16 Cutler St, Suite 104, Warren, RI, 02885. Email info at firmfound dot org for questions or comments.

Tuesday, 9 December 2014

Princess Health and Stryker Subsidiary Pleads Guilty to Selling Adulterated Devices, Former CEO of Subsidiary Pleads Guilty to Fraud, Stryker's Track Record Goes Unremarked. Princessiccia

Princess Health and Stryker Subsidiary Pleads Guilty to Selling Adulterated Devices, Former CEO of Subsidiary Pleads Guilty to Fraud, Stryker's Track Record Goes Unremarked. Princessiccia

The US Thanksgiving Day parade is over, so it must be time for the march of legal settlements to begin again. Our next example was best described by Bloomberg and by NJcom, but brief articles from the Associated Press, Reuters, and the Wall Street Journal have also appeared.

The Basic Facts

The Bloomberg lede was,

Stryker Corp. OtisMed unit pleaded guilty to selling devices used in knee-replacement surgeries in September 2009 without regulatory approval and will pay more than $80 million to resolve the case.

The conduct in question was,

The company admitted it never obtained U.S. Food and Drug Administration approval to sell 18,000 custom-built devices used by surgeons from 2006 to 2009 to make accurate bone cuts to implant prosthetic knees. OtisMed applied for FDA approval in October 2008, and the agency said 13 months later the company hadn�t shown it was safe and effective. [OtisMed CEO Charlie] Chi then shipped 218 devices to surgeons, overruling his advisers and board.

Furthermore, in this case, there was some information about who actually did what,

After a conference call with OtisMed directors on Sept. 9, 2009, Chi talked to two employees about ways to hide the shipments from the FDA, including taking them to an off-site shipping location, using Chi�s personal Federal Express account, and backdating shipping documents, court records show.

The NJ.com report clarified to what charges the guilty pleas referred,

Charlie Chi, 45, pleaded guilty to three misdemeanor counts of fraud linked to the September 2009 shipment of 218 OtisMed devices to surgeons throughout the U.S., including 16 in New Jersey.

Also,

OtisMed, which was acquired by Stryker Corp., pleaded guilty to a felony charge of distributing adulterated medical devices into interstate commerce.... 

So, a company acquired by large medical device manufacturer Stryker admitted and pleaded guilty to charges that it fraudulantly marketed an unapproved device, and that this marketing was lead and facilitated by the company's CEO.  The CEO pleaded guilty to misdemeanor fraud charges.

The Penalties

Per Bloomberg,

OtisMed will pay a fine of $34.4 million and forfeit $5.16 million in a criminal case, while paying a civil fine of $41.2 million. The company pleaded guilty today in federal court in Newark, New Jersey, where former Chief Executive Officer Charlie Chi also pleaded guilty.

Chi has not yet been sentenced, but according to NJ.com,

Chi, of San Francisco, faces up to three years in prison when he�s sentenced on March 18, 2015.

Bloomberg noted that,

The $80 million payment is almost three times the total revenue that OtisMed got for all of the knees the company sold, according to Fishman.

However, the amount could also be compared to the approximate annual revenue of Stryker Corp, which was most recently about $8 billion per Google Finance, or its net income, about $1 billion.

Furthermore,

OtisMed was barred from Medicare, Medicaid and all other federal health-care programs for 20 years. Stryker, based in Kalamazoo, Michigan, wasn�t barred.

This case was unusual in that a health care corporate CEO was actually charged and pleaded guilty to crimes connected to illegal marketing practices, and in that his company not only admitted wrongdoing and pleaded guilty, but also agreed to disbarment from federal programs.  However, by the time the case was thus decided, the CEO was no longer CEO, his company had been acquired by a larger health care corporation, and that corporation, while letting its new subsidiary agree to a fine and disbarment, was not itself disbarred from anything. 

Stryker's Track Record 

The Bloomberg noted that Stryker did not have unblemished track record,


In 2007, New Jersey�s U.S. attorney at the time, Chris Christie, reached an agreement with four makers of hip- and knee-implants that paid $310 million to settle U.S. claims they paid kickbacks to surgeons who used their products. Stryker, a fifth company, received a non-prosecution deal. Christie, a possible Republican presidential candidate in 2016, is now governor.

In fact, that year, we posted (here, here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves.

However, there is much more to the Stryker track record,

In 2013, we noted that Stryker paid $13.2 million to settle charges that it bribed doctors in various countries to use its devices, violating the US Foreign Corrupt Practices Act (FCPA) (look here).

In 2012, we noted that Stryker paid a $15 million fine after pleading guilty to a federal count of misbranding a medical device. Government prosecutors alleged the company conspired to defraud surgeons into combining two of its products, contrary to their labeled usage, and possibly harming patients (look here).

In 2010, we noted that Stryker paid $1.35 million to settle charges that it marketed bone growth products without FDA approval (look here).

In 2009, we noted that two Stryker sales representatives pleaded guilty to charges they promoted off-label use of Stryker bone growth products although they knew such use could endanger patients (look here).  

So the larger corporation that paid fines that appeared large, but were actually small given its size, and that let its subsidiary and its subsidiary's former CEO otherwise take the raps, had a long track record of similarly questionable behavior.  That track record did not apparently inform the resolution of the current case.


Summary

So here we go again. A large medical device company resolved charges of wrongdoing by paying a fine that appears large to the common person, but in fact was small compared to its revenue.  The case was unusual in that the company did admit wrongdoing, but in a way that seemed to reflect the blame onto one of its subsidiaries.  The case was further unusual in that a CEO was charged and pleaded guilty, but it was not the CEO of the large corporation, but the former CEO of the acquired company.  The case was yet further unusual in that a company was disbarred from transactions with the federal government, but the company was just the subsidiary of the larger company, which otherwise could continue business as usual. 

Thus while the penalties meted out in this case seemed more severe than usual, on examination they left the big parent corporation relatively unscathed.  No one still in management at that corporation, including anyone involved in the acquisition of the wayward subsidiary, apparently will suffer any negative consequences.  Furthermore, that larger corporation turns out to have a substantial track record of previous misbehavior.  Yet that did not apparently affect the outcome of this case, and little of this track record was even reflected in the reporting of the current case.

While we have often - some might say ad infinitum - discussed the march of legal settlements by large health care organizations, and how these settlements seem to impose relatively small penalties on the corporations, and leave their hired managers untouched, these settlements seem to produce few echoes.  Like many other examples of unpleasantness that might reflect badly on the leaders of large health care organizations, even those who may have personally profited from the unpleasantness, they remain largely anechoic.  So we would urge the reporters who cover the next settlements by big health care organizations at least look to see if the organizations had been involved in similar settlements in the past

Finally, as we have said all to often,...   The failure of the current limp legal efforts against such corruption is evident by how many corporations have become ethical repeat offenders.  Pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction.  So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue.