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Did Joint Commission Accredit a Hospital Whose Understanding of Medication Reconciliation is Recklessly Superficial?

I submitted this complaint to the Joint Commission today. I've been challenging them in recent years (especially since my JAMA letter "<a href="http://jama.jamanetwork.com/article.aspx?articleid=184302" target="_blank">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</a>" on hospital executive's violation of JC Safety Standards of July 2009) over the issue of their accreditation of hospitals using bad health IT. Eventually, I hope, they will take a leadership role on health IT risk, lest they become a target for litigation.  (I think they're already there for their inaction on EHR problems despite admitted knowledge of the problems, in print, e.g., in their 2009 Sentinel Events Alert on Health IT Risks.) Here is my complaint submitted both via email and via the Joint Commission "<a href="http://www.jointcommission.org/report_a_complaint.aspx" target="_blank">Report a Complaint online</a>" page.  I added a few comments for readers in [bold red italics] that, of course, were not part of the submission: ------------------------------ Thank you for submitting your complaint!     Monday, August 20, 2012 Your complaint incident number is:     ########-######## ------------------------------ Dear Joint Commission, <div class="MsoNormal">I also sent this complaint to<a href="mailto:PSchyve@jointcommission.org" target="_blank"></a> PSchyve, AGiuntoli and MChassin via email.</div><div class="MsoNormal"> </div><div class="MsoNormal">You are already aware of the injury and death from Med Recon failure of my mother at [name redacted] Hospital, in an incident that began May 19, 2010.  Reference Incident #######-######.</div><div class="MsoNormal"> </div><div class="MsoNormal">I am also filing the issue below as a formal JC complaint:</div><div class="MsoNormal"> </div><div class="MsoNormal">As demonstrated in the sworn defense response by [name redacted] Hospital today, 8/20/12, the hospital has a very superficial understanding of Med Recon and Med Recon Failure.  </div><div class="MsoNormal"> </div><div class="MsoNormal">I am assuming they passed Joint Commission Accreditation that includes the ability to ensure continuity of care, including giving correct meds via Med Recon.</div><div class="MsoNormal"> </div><div class="MsoNormal">The hospital through defense counsel today (8/20/12) writes in a document I've placed at [URL redacted]:  <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/00235447.pdf" target="_blank"></a></div><div class="MsoNormal"> </div><blockquote class="tr_bq"><div class="MsoNormal">... 4.  As plead [sic -ed.], the <a href="http://legal-dictionary.thefreedictionary.com/gravamen" target="_blank">gravamen</a> [the basic gist of every claim or charge in a complaint - ed.] of Plaintiffs complaint is the allegation that he told the treating professionals about Mrs. Silverstein's Sotalol medication.</div><div class="MsoNormal"> </div><div class="MsoNormal">5.  Therefore, the central issue of this case is one of human communication- i.e., whether Dr. Silverstein told the various staff or not.  [In other words, their obligations to check medications end there - ed.]</div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">In fact, the complaint was quite clear:</div><div class="MsoNormal"> </div><div class="MsoNormal">...32.  The tortious conduct of defendant [name redacted] Hospital consisted of the following:</div><div class="MsoNormal"> </div><blockquote class="tr_bq"><div class="MsoNormal">a. vicarious liability for the actions of its agents [redacted], [redacted] and [redacted] to ensure continuation of the Sotalol therapy [can we all agree that's a primary responsibility of a hospital and its agents? - ed.];</div><div class="MsoNormal"> </div><div class="MsoNormal">b. vicarious liability for the actions of its agents [redacted], [redacted] and [redacted] to ensure proper operation of the defendant’s EMR system so as to ensure continuation of a presently active medication;</div><div class="MsoNormal"> </div><div class="MsoNormal">c. vicarious liability for the failure of its agents identified in this complaint to adequately communicate Ms. Silverstein’s complete medication history with the subsequent treating health care providersduring this admission;</div><div class="MsoNormal"> </div><div class="MsoNormal">d. vicarious liability for the failure of its agents, identified in this complaint, to question why no Sotalol was ordered given the noted history of arrhythmia [a medical student-level question - ed.];</div><div class="MsoNormal"> </div><div class="MsoNormal">e. failure to have in place adequate procedures or policies to insure that presently active medications are continuously active in the EMR system unless deactivated by an appropriately qualified health care provider;</div><div class="MsoNormal"> </div><div class="MsoNormal">f. failure to have in place adequate procedures or policies to insure that the computer generates appropriate alerts for others to see when critical medications become inactive;</div><div class="MsoNormal"> </div><div class="MsoNormal">g. failure to properly assess the operational effectiveness of its EMR system so as to insure that presently active medications are automatically continued unless specifically deactivated by a qualified and authorized health care provider.</div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">33. As a result of the above identified failures in medication administration and medical record charting, Ms. Silverstein has suffered the following:</div><div class="MsoNormal"> </div><blockquote class="tr_bq"><div class="MsoNormal">a. Intracranial hemorrhage; b. atrial fibrillation; c. damage to her nerves and nervous system, including memory difficulties, and seizure activity; d. brain compression due to the intracranial hemorrhage; e. requirement for additional procedures; f. prolonged hospitalizations; g. need for rehabilitation; h. need for continuous therapies; i. pain, suffering, embarrassment, humiliation, and the loss of life’s pleasures; j. death. </div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">While I gave the history of Sotalol to the clinicians on 5/19/10 (my mother had been on it dating to 2002) as I had done multiple times in this ED, this hospital seems to believe its Med Recon responsibilities end at the family - even when they have records in abundance in their paper records and EHRs (ED and floor), including from just a few weeks prior, with current med lists.</div><div class="MsoNormal"> </div><div class="MsoNormal">I note (as I had previously sent you) that Pennsylvania's Medicare QIO, Quality Insights, found the hospital had failed in medication continuity, and that the failure to administer Sotalol caused the recurrent A. fib and subsequent complications, the care not meeting professionally accepted standards. [The formal terminology for "malpractice" - ed.]</div><div class="MsoNormal"> </div><div class="MsoNormal">If you accredited this hospital, as I believe you did, this superficial understanding of Med Recon that you apparently missed or recklessly glossed over poses a serious danger to the community, and contributed materially to my mother's injuries, suffering and death.</div><div class="MsoNormal"> </div><div class="MsoNormal">Sincerely,</div><div class="MsoNormal"> </div><div class="MsoNormal">S. Silverstein, MD</div><div class="MsoNormal"> </div><div class="MsoNormal">Cc:  [attorney handling the malpractice lawsuit]</div><div class="MsoNormal"> </div><div class="MsoNormal">- end complaint -</div><div class="MsoNormal"></div><div class="MsoNormal"> --------------------</div><div class="MsoNormal"> </div><div class="MsoNormal">They defense is also trying to deflect the Judge from the issue of Metadata: <blockquote class="tr_bq">... At this point in time, it is respectfully submitted that the proposed electronic discovery is not relevant to the central issue of this case. For example, if the Triage Nurse and subsequent providers were all to testify that Dr. Silverstein never informed them that Sotalol was a current medication of Mrs, Silverstein, then the fact that medical record does not record this as a current medication has nothing to do with metadata. </blockquote> Wrong. "The fact that medical record does not record Sotalol as a current medication" after the ED encounter on 5/19/10 indicates a forensic examination of the metadata is crucial. It is in fact only through metadata that it can be determined if the medication, listed as "current" only a few weeks prior and normally visible when the user brings up a patient's record to initiate triage, was deleted by the user (e.g., via "use error" per NIST, related to bad IT design) and how and when; if it ended up in another patient's chart due to malfunction (misidentification); if the EHR malfunctioned and simply erased the med; if the chart was altered to try to hide the mistake, etc.  These are all well known failure modes.  See an example of what metadata can show <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">at this link</a> in a case that settled for over $1 million before a trial even began. In fact, over and above potentially misrepresenting my and my mother's stated medication history at ED triage: Note their attempting to deflect attention away from health IT and the med recon failure of their own staff.   Also note a reckless understanding of Medication Reconciliation, that seems to imply the hospital believes it had no duty to reconcile meds with itself, that is, check its own EHR or paper records from just a few weeks prior along with multiple others dating back 8 years, or check with the hospital-affiliated primary care and other physicians treating the patient for years, who were reachable via a simple phone call.  Instead, the issue of whether a family member told "them about the med or not" seems to be their central defense.    On the issue of who's actually responsible (and liable) for Med Recon, from the American Medical Association monograph entitled "<a href="http://www.ama-assn.org/resources/doc/cqi/med-rec-monograph.pdf" target="_blank">The physician’s role in medication reconciliation</a>", pg. 3.   <blockquote class="tr_bq">... The essence of medication reconciliation is making sense of a patient’s medications and resolving conflicts between different sources of information [paper, electronic, verbal, information from other physicians treating the patient, etc. - ed.] to minimize harm and to maximize therapeutic effects. It is an ongoing, dynamic, episodic and team-based process that should be led by and is the responsibility of the patient’s attending or personal physician in collaboration with other health care professionals. Medication reconciliation is essential to optimize the safe and effective use of medications. It is one element in the process of therapeutic use of medications and medication management for which physicians are ultimately held legally accountable. </blockquote> The AMA monograph has a special section starting on p. 20 on IT and Med Recon.  It warns explicitly about practicing medicine like a mindless robot: <blockquote class="tr_bq">... IT systems and applications do have the potential to streamline the medication reconciliation process—especially assembling and storing patient information—and to provide the means to effectively transfer patient medication information across the continuum of care. However, health care technology is fragmented and requires close attention by potential users to ensure that implementation does not create additional pressures and problems with accuracy of medications.</blockquote> The apparent hospital misunderstanding of Med Recon could - and in my view, should - result in charges of gross negligence, perhaps criminal, against its medical leadership if other patients have been, or are, harmed as a result of resultant medication reconciliation errors. Of course, it's also possible that the defense is <a href="http://hcrenewal.blogspot.com/2012/08/defense-attorney-lies-under-oath-to.html" target="_blank">just making stuff up again</a> to try to blow smoke up the judge's behind.  However, what's sworn certainly should not be lightly dismissed.  I also note that this hospital is making a spectacle of itself in front of the Judge, the President Judge in the county where it conducts operations, who already dismissed a boatload of meritless claims.  That does not bode well for them in the future. </div><div class="MsoNormal"> </div><div class="MsoNormal">-- SS</div>

Did Joint Commission Accredit a Hospital Whose Understanding of Medication Reconciliation is Recklessly Superficial?

I submitted this complaint to the Joint Commission today. I've been challenging them in recent years (especially since my JAMA letter ...

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Paging Doctor EBDITA - How Private Equity May Push Hospitals to Put Revenue Ahead of Patient Care

Issues raised by the increasing influence of <a href="http://hcrenewal.blogspot.com/search/label/private%20equity">private equity</a> firms in the direct care of patients were illuminated by a series of articles about the for-profit hospital chain HCA. Quality Problems The articles highlighted a series of concerns about quality problems affecting the chain's patients.  Cardiac Overtreatment First, a New York Times <a href="http://www.nytimes.com/2012/08/07/business/hospital-chain-internal-reports-found-dubious-cardiac-work.html">article</a> described problems in the care of cardiac patients.  <blockquote>HCA, the largest for-profit hospital chain in the United States with 163 facilities, had uncovered evidence as far back as 2002 and as recently as late 2010 showing that some cardiologists at several of its hospitals in Florida were unable to justify many of the procedures they were performing. Those hospitals included the Cedars Medical Center in Miami, which the company no longer owns, and the Regional Medical Center Bayonet Point. In some cases, the doctors made misleading statements in medical records that made it appear the procedures were necessary, according to internal reports. </blockquote> More specifically, at one hospital, cardiac catheterizations seemed to occur to often: "about half the procedures ... were determined to have been done to patients without significant heart disease." Two patients at another hospital had severe adverse effects after cardiac procedures that seemed unnecessary in retrospect. There were "incidents at Bayonet Point where patients were treated for multiple lesions, or blockages, even when 'the second lesion (or third) did not appear to have significant disease....' [In] 'several cases'  ... patients were treated even though their arteries did not have significant blockages." Then, <blockquote>HCA brought in an external company, CardioQual Associates of Franklin, Mich., in 2004 to examine medical records from Bayonet Point. In a confidential memo prepared in December 2004 and reviewed by The Times, CardioQual concluded that as many as 43 percent of 355 angioplasty cases, where doctors performed invasive procedures to open up a patient’s arteries, were outside reasonable and expected medical practice. Worse, the investigation revealed that some physicians had indicated in medical records that the patients had blockages of 80 to 90 percent when a later, more scientific analysis of a sampling of cases revealed the blockages had ranged from 33 to 53 percent.</blockquote> Possible Undertreatment of Acute Illness Then, a second NY Times <a href="http://www.nytimes.com/2012/08/15/business/hca-giant-hospital-chain-creates-a-windfall-for-private-equity.html">article</a> found that <blockquote>HCA decided not to treat patients who came in with nonurgent conditions, like a cold or the flu or even a sprained wrist, unless those patients paid in advance. In a recent statement, HCA said that of the six million patients treated in its emergency rooms last year, 80,000, or about 1.3 percent, 'chose to seek alternative care options.'</blockquote> Of course, the problem with this approach is that it is not always possible to tell how severe an acute illness is without a more complete evaluation than can be done in emergency department triage. There is anecdotal evidence that HCA turned away some patients who actually had serious illness: <blockquote>Regulators in several states have taken HCA hospitals to task over screening out patients too aggressively, including situations where the screening missed serious conditions. In early 2010, an uninsured patient who entered HCA’s TriStar Skyline Medical Center in Nashville, complaining of 'pain when breathing,' was sent away. An hour and a half later, at another hospital, the same patient was found to have pneumonia, according to the results of a Medicare investigation. Regulators cited Skyline for having 'failed to ensure that an appropriate medical screening examination was conducted.' This year, the Office of Inspector General fined HCA’s Northside Hospital in St. Petersburg, Fla., $38,000 for sending home a feverish patient with an artificial heart valve. Two days later, the patient reappeared with the flu and severe respiratory problems. The following day, he died. </blockquote> Undertreatment of Bed Sores The second Times <a href="http://www.nytimes.com/2012/08/15/business/hca-giant-hospital-chain-creates-a-windfall-for-private-equity.html">article </a>also suggested that decreased nurse staffing at HCA hospitals lead to worse treatment of bed sores (decubitus ulcers): <blockquote>Experts say there is often a direct correlation between bedsores and the quality of hospital staff levels. 'Staffing is critical,' said Courtney H. Lyder, the dean at the UCLA School of Nursing and an expert on wound care. 'When you see high levels of wounds, you usually see a high level of dysfunctional staff,' he said. HCA owned eight of the 15 worst hospitals for bedsores among 545 profit-making hospitals nationwide, each with more than 1,000 patient discharges, tracked by the Sunlight Foundation using Medicare data from October 2008 to June 2010. HCA’s West Houston Medical Center and CJW Medical Center in Richmond, Va., landed near the top of the list. HCA says it has increased its nursing staff at its hospitals each year over the last five years. But an examination of lawsuits shows bedsore problems have been persistent at several HCA facilities. In Portsmouth Regional Hospital in New Hampshire, a 60-year-old woman died in 2009 after her bedsores went untreated for three days and became infected, according to a wrongful-death lawsuit filed in the spring of 2011 in federal court against the hospital.</blockquote> One HCA hospital <blockquote>was cited twice by Florida regulators, in 2008 and 2010, for having inadequate numbers of nurses on its staff to oversee wound care for patients. During the 2010 examination, regulators noted that Memorial had less than the equivalent of two full-time nurses who specialized in wound care to treat the 132 patients who required aid. 'The system of treatment for wound care places patients at risk for additional medical complications,' the examiners said. </blockquote> So, in summary, there is reason for concern about overtreatment of cardiac disease, and undertreatment of acute illness and bedsores at HCA hospitals. However, no hospital and no doctor is perfect. Everyone makes mistakes, and many decisions can be questioned in retrospect. Instead Putting Money Ahead of Quality Instead, the articles suggested they were part of a pattern in which concerns about short-term revenue trumped concerns about patient care. Cardiac Procedures to Generate More Revenue The <a href="http://www.nytimes.com/2012/08/07/business/hospital-chain-internal-reports-found-dubious-cardiac-work.html">article</a> about cardiac care noted that one of the physicians who allegedly was doing too many cardiac procedures <blockquote>was highlighted by the hospital in a 2009 business plan as being the most profitable doctor at the facility. 'Our leading EBDITA MD,' the plan described him. (Ebitda, or earnings before interest, taxes, depreciation and amortization, is a measure of corporate earnings.) </blockquote> On the other hand, <a href="http://www.tampabay.com/news/health/medicine/scrutiny-of-cardiac-care-at-pasco-hca-hospital-latest-in-long-saga/1244719">according to the Tampa Bay Times</a>, some of the doctors whom HCA suspended for doing too many percutaneous cardiac revascularization procedures charged that the issue was that <blockquote>far from concern over the cost of stents — Bayonet Point was upset that stents were replacing more expensive bypass surgeries.</blockquote> The first NY Times <a href="http://www.nytimes.com/2012/08/07/business/hospital-chain-internal-reports-found-dubious-cardiac-work.html">article</a> also suggested that HCA executives did their best to keep the issue quiet so as not to affect revenue. First, <blockquote>HCA declined to provide evidence that it had alerted Medicare, state Medicaid or private insurers of its findings, or reimbursed them for any of the procedures that the company later deemed unnecessary, as required by law. </blockquote> Also, <blockquote>HCA also declined to show that it had ever notified patients, who might have been entitled to compensation from the hospital for any harm. </blockquote> The Times uncovered internal HCA communications suggesting that obfuscation was deliberate: <blockquote>In January 2005, David Williams, who was then the chief executive of Bayonet Point, wrote in an e-mail: 'Clearly, we have protected ourselves under the peer review umbrella and have released very little information.' The recipients of his message included Dan Miller, who then oversaw HCA’s hospitals in western Florida, and Charles R. Evans, a Nashville executive who was president of all of HCA’s hospitals on the eastern side of the country. In his response, Mr. Evans thanked Mr. Williams for the update and asked for a 'summary as to the business impact.' </blockquote> Furthermore, as the last sentence above indicated, review of internal emails suggested that executives were more worried about revenue than quality of care or patient outcomes: <blockquote>A review of those communications reveals that rather than asking whether patients had been harmed or whether regulators needed to be contacted, hospital officials asked for information on how the physicians’ activities affected the hospitals’ bottom line. </blockquote> Avoiding Caring for Poor Patients in the Emergency Department On the other hand, the impetus for triaging away apparently less acutely ill patients from the Emergency Department was to avoid such patients who could not pay. The <a href="http://www.nytimes.com/2012/08/15/business/hca-giant-hospital-chain-creates-a-windfall-for-private-equity.html">second NY Times article </a>noted there was a way for supposedly less ill patient to get Emergency Department treatment, <blockquote>Patients whose ailments were not deemed urgent were told to go somewhere else, like a free clinic, or that they could be treated if they paid the co-payment for their insurance or around $150 in cash. </blockquote> In addition, there is reason to think that HCA management pushed health care professionals to put off increasing numbers of patients, regardless of their clinical problems, <blockquote>Several former emergency department doctors at Lawnwood Regional Medical Center in Fort Pierce, Fla., said they frequently had felt compelled to override the screening system in order to treat patients. </blockquote>Also, <blockquote>'Physicians had a really, really hard time with it,' said Dr. J. Patrick Pearsall, who worked for an emergency physician group based in Houston that worked in HCA hospitals. When the doctors failed to meet the hospital’s goals for how many patients should be considered emergencies, 'they really started putting pressure on.' One emergency room doctor who worked at an HCA Florida hospital said doctors had been told they had targets to hit. The doctors’ concerns about the screening policy were acknowledged in an e-mail reviewed by The Times that was sent to the doctors at the hospital in early 2008 by an outside company that worked in the emergency room. The doctors were told HCA’s regional executives were 'quite intent on pursuing this program at least for the time being and fully expects us to comply. Their expectations are that approximately 15 percent of all patients are to be screened and of those screened no more than 35 percent overridden.' </blockquote> Keep in mind that variations in patient populations over time and across geographic areas means that the proportions of more and less severely ill patients showing up at individual Emergency Departments will vary substantially. Pressuring health care professionals to turn away a minimum percentage of people will make it very likely that at some times severely acutely ill patients will not be seen. So it appears that at HCA, patients sometimes were overtreated, and sometimes were undertreated, and that executives trying to increase revenue may have been more responsible for both than simple human error. Finally, there is reason to think that the take-over of HCA by private equity (that is, leveraged buy-out) firms further increased the for-profit corporation's emphasis on short-term revenue leading to worsening quality of care. Private Equity Pushed for Even More Short-Term Revenue The second NY Times <a href="http://www.nytimes.com/2012/08/15/business/hca-giant-hospital-chain-creates-a-windfall-for-private-equity.html">article</a> first noted, <blockquote>During the Great Recession, when many hospitals across the country were nearly brought to their knees by growing numbers of uninsured patients, one hospital system not only survived — it thrived. In fact, profits at the health care industry giant HCA, which controls 163 hospitals from New Hampshire to California, have soared, far outpacing those of most of its competitors. The big winners have been three private equity firms — including Bain Capital, co-founded by Mitt Romney, the Republican presidential candidate — that bought HCA in late 2006. HCA’s robust profit growth has raised the value of the firms’ holdings to nearly three and a half times their initial investment in the $33 billion deal. The financial performance has been so impressive that HCA has become a model for the industry.</blockquote> Note that the private equity firms extracted a considerable amount of cash from HCA at the time they turned it back into a publicly held for-profit corporation: <blockquote>In 2010, buoyed by robust growth in profit, HCA was able to issue billions of dollars in debt that was used to pay funds overseen by the three buyout firms nearly $1 billion in dividends — each. In the spring of 2011, in one of the most closely watched public offerings since the financial crisis, HCA became a public company once again. Its three buyout owners each sold another $500 million worth of stock, allowing them to recoup all their initial investment.</blockquote>By thus increasing the new public corporation's debt load, they further increased pressure on its executives to bolster short-term revenue. However, <blockquote>As HCA’s profits and influence grew, strains arose with doctors and nurses over whether the chain’s pursuit of profit may have, at times, come at the expense of patient care. </blockquote> Summary:  Why No Hospital Should be For-Profit? Among all developed countries, I believe only the US has such a high proportion of for-profit hospitals, and physicians employed by for-profit corporations to take care of patients. However, in summary, this case shows there is evidence that - The management of one for-profit hospital chain was pushed to focus even more on short-term revenue by a leveraged buy-out engineered by private equity firms - This focus lead management to pressure health care professionals to increase revenue, even if that required over- or under-treating patients - The resulting over- and under-treatment likely harmed patients. As a Tampa Bay Times <a href="http://www.tampabay.com/opinion/editorials/hcas-prescription-for-profits/1245248">editorial</a> put it, <blockquote>the allegations suggest a disturbing pattern of endangering patients, and they again expose the weaknesses of a health care system driven by volume and profit rather than efficiencies and patient outcomes.</blockquote> In a <a href="http://www.forbes.com/sites/stevedenning/2012/08/15/private-equity-wont-fix-health-care-either/">column</a> in Forbes, Steve Denning warned, <blockquote>The hospitals owned by private equity are making money in the short-term at the expense of Medicare and the economy. But when the private equity firms depart, as they plan to do, they leave the hospitals with a load of debt, dispirited doctors and nurses, and a bankrupt Medicare system, with serious questions as to whether overall care has been maintained, let alone improved. The current bonanza for private equity from milking Medicare is a bubble that cannot be sustained.</blockquote> We have <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">noted</a> how health care organizations have increasingly been "financialized," lead by executives who put short-term revenue generation ahead of all other goals, including good patient care. Furthermore, hospitals are increasingly likely to be formally for-profit, and hence likely to be lead by such executives. Worse, hospitals are increasingly likely to be owned by <a href="http://hcrenewal.blogspot.com/search/label/private%20equity">private equity</a> firms, further increasing the emphasis on short-term money making. Even worse, physicians are now more frequently <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">employed by such organizations</a>, which may pressure them to do what it takes to increase revenue, no matter what the effect on patients' and the public's health. The probably effects on the quality of care, access, and costs are obvious. In my humble opinion, before the health care bubble bursts, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. Before market fundamentalism became so prominent, many stated prohibited the corporate practice of medicine, and the American Medical Association <a href="http://hcrenewal.blogspot.com/2007/12/relman-in-jama-on-threats-to-physicians.html">forbade the commercialization of medicine.</a> It is time to heed that wisdom. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care. As Todd Hixon wrote, surprisingly <a href="http://www.forbes.com/sites/toddhixon/2012/08/16/where-the-market-approach-to-health-care-completely-fails/">in Forbes</a>, <blockquote>I believe a big part of the answer lies in changing the idea that health care should be a path to riches. There are professions, like university teaching and research, where a big part of the motivation is helping people and gaining respect in the community. If we could shift the balance for health care providers in that direction, solving problems like the one manifest at HCA would be a lot more possible.</blockquote> True health care reform will require an end to market fundamentalism in health care. Note - See also <a href="http://runningahospital.blogspot.com/2012/08/lets-do-numbers.html">comments</a> by Paul Levy in the Not Running a Hospital Blog.

Paging Doctor EBDITA - How Private Equity May Push Hospitals to Put Revenue Ahead of Patient Care

Issues raised by the increasing influence of private equity firms in the direct care of patients were illuminated by a series of articles a...

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Health IT difficulties and controversial excuses from health IT hyperenthusiasts and extremists

As I observed at my Aug. 15, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/contra-costas-45-million-computer.html">Contra Costa's $45 million computer health care system endangering lives, nurses say</a>" and other posts, common in case reports of health IT difficulties is the refrain (usually from a seller, healthcare executive or health IT pundit) that: <ul><li>It's a rare event, it's just a 'glitch',  it's teething problems, it's a learning experience, we have to work the 'kinks' out, it's growing pains, etc.</li></ul> Or perhaps worse: <ul><li>Patient safety was not compromised (stated long before the speaker or writer could possibly know that).</li></ul> What these statements translate to:  any patient harm that may have resulted is for the "greater good" in perfecting the technology. Here is the problem with that: These statements, while seemingly banal, are actually highly controversial and amoral. and reflect what can be called "faith-based informatics beliefs" (i.e., enthusiasm not driven by evidence). They are amoral because they significantly deviate from accepted medical ethics and patient rights, especially regarding experimentation or research such as the plain language of the <a href="http://history.nih.gov/research/downloads/nuremberg.pdf" target="_blank">Nuremberg code</a>, the <a href="http://videocast.nih.gov/pdf/ohrp_belmont_report.pdf" target="_blank">Belmont Report</a>, World Medical Association <a href="http://history.nih.gov/research/downloads/helsinki.pdf" target="_blank">Declaration of Helsinki</a>, <a href="http://www.nccamwatch.org/research/human_guidelines.pdf" target="_blank">Guidelines for Conduct of Research Involving Human Subjects at NIH</a>, and <a href="http://bioethics.od.nih.gov/IRB.html" target="_blank">other documents</a> that originated out of medical abuses of the past. Semantic or legal arguments on the term "research", "experimentation" etc. are, at best, misdirection away the substantive issues.  Indeed, for all practical purposes the use of unfinished software (or software with newly-minted modifications) that has not been extensively tested and validated and that is suspected to or known to cause harm, without explicit informed consent, is contrary to the spirit of the aforementioned patients' rights documents. They are excuses from health IT hyper-enthusiasts ("<a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">Ddulites</a>"), who in fact have become so hyper-enthusiastic as to ignore the ethical issues and downsides.  The attitude gives more rights to the cybernetic device and its creators than to the patients who are subject to the device's effects. These excuses are, in effect, from people who it would not be unreasonable to refer to as technophile extremists. -- SS Addendum: The <a href="http://videocast.nih.gov/pdf/ohrp_belmont_report.pdf" target="_blank">Belmont Report</a> of the mid to late 1970's, long before health IT became at all common, actually starts out with a section discussing "BOUNDARIES BETWEEN PRACTICE AND RESEARCH."  I have updated one of the observations in that section to modern times: <blockquote class="tr_bq"> ... It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects of research. ... When a clinician [or entire healthcare delivery system - ed.] departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different, does not automatically place it in the category of research. Radically new procedures of this description [such as use of cybernetic intermediaries to regulate and govern care - ed.] should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation [such as health IT - ed.] be incorporated into a formal research project. </blockquote> Health IT appears to have been "graduated" from experimental to tried-and-true without the formal safety research called for in the Belmont report. The Belmont report continues: <blockquote class="tr_bq">Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects. </blockquote> Instead, what we have for the most part are excuses and special accommodations for health IT, on which the <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">literature is conflicting</a> regarding safety and efficacy, all the way up to the <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">Institute of Medicine</a>. -- SS

Health IT difficulties and controversial excuses from health IT hyperenthusiasts and extremists

As I observed at my Aug. 15, 2012 post " Contra Costa's $45 million computer health care system endangering lives, nurses say ...

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EHR sabotage for ransom: Try this with paper!

I have frequently written that health IT, touted as a technology that will deterministically "transform medicine", allows (aside from clinical chaos) new sorts of problems, such as information security abuses en masse, to occur.  See this query link for numerous postings on that topic:  <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a> I am not, of course, advocating a return to paper; I am in fact "pro-good IT" but "anti-bad IT." "Bad IT" is IT that interferes with quality patient care for any reason, permits evidence spoliation, permits overbilling, exposes confidential medical information to unauthorized parties, etc. Here is another example of unintended consequences of bad health IT.  Try this trick with paper: <blockquote class="tr_bq"><a href="http://www.cio.com/article/713605/Attackers_Demand_Ransom_After_Encrypting_Medical_Center_s_Server" target="_blank">Attackers Demand Ransom After Encrypting Medical Center's Server</a> John E Dunn, Techworld August 14, 2012  Details have emerged of an extraordinary data breach incident in which a U.S. medical practice had thousands patient records and emails encrypted by attackers who then demanded a ransom to unscramble the data. The incident appears to have come to light after a security blogger 'Dissent Doe' noticed a data breach report made by Illinois-based The Surgeons of Lake County medical centre to the US Department of Health and Human Services. According to a small newswire that reported events, attackers were able to compromise one of the medical centre's servers, encrypting its contents including 7,067 patient records and a quantity of emails. The first the centre knew about the attack was on 25 June when a ransom note for an undisclosed sum was posted on the server, at which point it was turned off. It is not clear whether the data was recovered through backups but the organisations reported the incident to the police and Department of Health. ... What marks the compromise out from almost every data breach attack recorded is that the attackers opted to extort the victim organisation rather than attempting to sell or exploit the data itself.  [Cyber criminals should never be assumed to be uncreative - ed.] It remains unlikely that the intention was to abuse this data directly; having occurred only days before the extortion note was received, the criminals would normally want a longer period to execute data and identity theft crimes. Most data theft criminals attempt to go undetected for this reason. The criminals will, nevertheless, had access to sensitive data including names, addresses, social security and credit cards numbers plus medical records, prompting the centre to inform its affected patents of the breach. "This is a warning bell. Maybe they're the canary in the coal mine that unpredictable things can happen to data once it's digitized," [you think? - ed.] said Santa Clara University law school professor, Dorothy Glancy, quoted by Bloomberg. </blockquote> This incident is, quite simply, stunning.  In addition to identity theft concerns, a patient whose information was cybernetically 'held hostage' could have suffered clinically as a result. A warning bell indeed about "bad IT." -- SS

EHR sabotage for ransom: Try this with paper!

I have frequently written that health IT, touted as a technology that will deterministically "transform medicine", allows (aside f...

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Contra Costa's $45 million computer health care system endangering lives, nurses say

I am providing a number of editorial comments about this familiar story of health IT difficulties (in red italics), and additionally highlighting familiar themes I have written about at this blog.  This story is rich in those themes: <blockquote class="tr_bq"><a href="http://www.mercurynews.com/breaking-news/ci_21313174/contra-costas-45-million-computer-health-care-system?refresh=no" target="_blank">Contra Costa's $45 million computer health care system endangering lives, nurses say</a> <div class="articleByline" id="articleByline"> <div class="bylinejb">By Matthias Gafni</div> <div class="bylineaffiliation">Contra Costa Times (CA)mercurynews.com</div></div><div class="articleDate" id="articleDate">Posted:   08/14/2012 05:30:07 PM PDT</div><div class="articleSecondaryDate" id="articleDate">August 15, 2012 3:55 AM GMTUpdated:   08/14/2012 08:55:52 PM PDT</div> </blockquote><div class="entry-content"><div class="articleBody" id="articleBody"><blockquote><div class="articleViewerGroup" id="articleViewerGroup" style="border-bottom: 0px; border-left: 0px; border-right: 0px; border-top: 0px;"></div>MARTINEZ -- A new medical computer system used at <a href="http://www.co.contra-costa.ca.us/index.aspx?NID=1927" target="_blank">Contra Costa correctional facilities</a> recommended what could have been a fatal dose of a West County Jail inmate's heart medication last week, an incident that a detention nurse characterized Tuesday as one of many recent close calls with the month-old program. However, the inmate's nurse was familiar with his medical history, recognized the discrepancy and administered the correct amount of Digoxin. It's just one of a number of computer errors that medical staffers say have been endangering inmates, medical staff and sheriff's deputies at the county's five jail facilities since Contra Costa switched on July 1 to EPIC, a computer system that links the correctional facilities to the Contra Costa Regional Medical Center and other county health care operations, two nurses and their union representative told the Contra Costa County Board of Supervisors on Tuesday. "It's dangerous. It's very dangerous," said an emotional Lee Ann Fagan in a phone interview. The registered nurse works at West County Detention Facility in Richmond. "It's hard to work in an environment that's so frustrating.  [Staff frustration increases risk of error and decreases morale, which increases risk of error further - ed.] </blockquote><blockquote>"What nurses want is for the EPIC program to go away until it's fixed," she said. The $45 million EPIC system integrates detention medical records with the other arms of the county health system. The system led to 142 nursing complaints in July, said California Nurses Association labor representative Jerry Fillingim, who told supervisors the system does not mesh well with detention health care. "I have never in all the time working with the California Nurses Association seen that many (complaints) be filled out," he said. "Each day, these nurses are fearful that they will kill somebody [requiring hypervigilance, which is emotionally and intellectually tiring, increasing risk of error further - ed.] ... I think the county tried to rush it, making it comprehensive for everything." EPIC has never included corrections in its software and is treating Contra Costa as a "guinea pig," Fillingim said.  [Subjects of this experiment don't get the opportunity for informed consent, I add - ed.]</blockquote> <blockquote><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjwNazAZuzInJ7QbfnxI8bxz8IjxlqoXGip7cj0GrHwuLBzcra8wGyTjfl-88chVpfrIPAx7AkAz_A7TIqf2LOtIoWhdl0P5fnFK2dS-4ad83qiOGStXqNXrElkRcYcYpBOgk_lfLUECwuS/s1600/guinea_pig_1-759711.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="213" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjwNazAZuzInJ7QbfnxI8bxz8IjxlqoXGip7cj0GrHwuLBzcra8wGyTjfl-88chVpfrIPAx7AkAz_A7TIqf2LOtIoWhdl0P5fnFK2dS-4ad83qiOGStXqNXrElkRcYcYpBOgk_lfLUECwuS/s320/guinea_pig_1-759711.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Guinea pigs to experiments don't give consent</td></tr></tbody></table> 'Just a tool' The county wanted to create a uniform electronic health record (EHR), and executives said the tool is important, but not the be-all, end-all. "The EHR is just a tool," said David Runt, chief information officer for the county health services department and who helped phase the system in over 18 months. "It's just one piece of the health care system. The people are the most important part of this process. We can't rely just on a computerized system."  [That's certainly a welcome and much more temperate position than the usual seller and pundit conceit that health IT will "transform" or "revolutionize" medicine.  It is also an especially good observation when the tool is unreliable! - ed.] ... "It's the beginning of a long journey that occurs over time," [i.e., an experiment - ed.] she said. "I think we can do a better job ... at how we communicate everything we're doing to respond to concerns." [The health IT industry has had several decades to "get it right."  When will the experiment end? - ed.] Management warned Staff superusers have warned management of EPIC issues, and two training sessions in May and June were inadequate, Fagan said. "They were next to useless because the program wasn't in place well enough to practice," she said. "Everyone in the classes could see the gross loopholes in information." Although nurses across the county's health care system have complained [but impediments to diffusion per FDA, IOM etc. prevented the complaints from becoming more widely known - ed.], the problems have been acute in detention, Fagan and Fillingim said. On Monday, one inmate told a nurse she was supposed to be seen by mental health specialists because she was hearing voices, but the follow-up appointment was not registered in the system. The same patient had a Pap smear scheduled for two weeks ago to test for sexually transmitted diseases, but the appointment disappeared from the system, Fagan said. Nurses cannot access tuberculosis history for inmates, so when some are transferred to Immigration and Customs Enforcement, staff cannot provide a full medical summary. "We don't exactly know how that happened; we can't tell," she said. </blockquote><blockquote>The kinks will be worked out, and patient safety issues rise to the top of the list, Runt said. ["kinks" is a synonym for that other common, milquetoast euphemism "<a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank">glitches</a>";  I also ask -  why does the statement that "patient safety issues rise to the top of the list" even have to be made - ever? - ed.] "When we go live is just a point in time, and now it becomes a period of stabilization and optimization," he said.</blockquote> I think the line "We don't exactly know how that happened; we can't tell" sums up the dangers of today's "EHR's", in reality enterprise clinical resource management and clinician workflow control systems, very well. I note that nurses in California may be a bit better prepared to recognize and call out the dangers of ill-designed and ill-implemented health IT than those in other states.  See my post "<a href="http://hcrenewal.blogspot.com/2012/03/rerun-health-information-technology.html" target="_blank">Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee</a>."</div><div class="articleBody" id="articleBody"></div><div class="articleBody" id="articleBody"> Regulation, anyone, or shall the experiment continue as-is? Finally, in my career to date, I have both experienced and heard many stories of this type of medical and organizational chaos that endangers patients.  The usual scenario is one of non-medical, domain-novice IT personnel and executives serving as the industry's defense (as in American football), doing their best to tackle anyone who speaks out.  Two such stories arrived in my inbox in just the past few weeks. The scenarios are also usually accompanied by amoral misdirection from these personnel away from patient risks via hackneyed excuses and euphemisms such as: it's a rare event, it's just a 'glitch', patient safety was not compromised, it's teething problems, it's a learning experience, we have to work the 'kinks' out, it's growing pains, it's the users' fault, etc.    Herein is the problem:  the attitude that a clinic full of non-consenting patients is an appropriate testbed for alpha and beta clinical software that puts them at risk is medically unethical, based on the guidelines developed from medical abuses of the past.  There is nothing to argue or debate about this. It is time to consider that some of the ignorant-to-the-point-of-endangerment or corrupt IT and other healthcare executives who do not listen to the concerns of clinicians, or actively block them from being disseminated and acted upon, should be subjected to charges of gross or even criminal negligence when harm occurs. <blockquote class="tr_bq"><a href="http://legal-dictionary.thefreedictionary.com/Gross+negligence" target="_blank">Gross negligence</a>: carelessness in reckless disregard for the safety or lives of others, which is so great it appears to be a conscious violation of other people's rights to safety. <a href="http://legal-dictionary.thefreedictionary.com/criminal+negligence" target="_blank">Criminal negligence</a>:  failure to use reasonable care to avoid consequences that threaten or harm the safety of the public and that are the foreseeable outcome of acting in a particular manner.</blockquote> Perhaps they'll enjoy experiencing a prison environment with a troublesome EHR firsthand.</div><div class="articleBody" id="articleBody"> </div><div class="articleBody" id="articleBody">-- SS </div></div>

Contra Costa's $45 million computer health care system endangering lives, nurses say

I am providing a number of editorial comments about this familiar story of health IT difficulties (in red italics ), and additionally highli...

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When Does Lavish Executive Compensation Become "Embezzlement?"

A <a href="http://www.miamiherald.com/2012/08/03/2930352/miami-beach-health-center-says.html">single article</a> in the Miami Herald raises the question of when is excessive executive compensation in health care too excessive.  To set up the question, I will be quoting from the story in an order quite differently from how the story was presented. Background The story is about the executives of the Miami Beach Community Health Center, described thus: <blockquote>Headquartered on Biscayne Boulevard in North Miami, the Miami Beach Community Health Center is one of the oldest and most well-respected public health clinics in Florida. It opened more than three decades ago, and now includes four locations, three on the Beach, including two sites that care for people with mental illness. The center employs more than 280 people, with a monthly payroll of around $1.2 million. The health center’s annual budget is about $36 million — about one-third of which comes from private insurance, Medicaid, the state and federal health insurance for needy people, Medicare, the federal insurer for elders, and private payments.</blockquote> The CEO's Compensation Previous stories, and public records suggested that the Center's CEO, Kathryn Abbate, was very well compensated. First, <blockquote>an October 2010 Miami Herald business story ..., relying on federal tax documents, reported Abbate’s compensation package as $824,000 in 2008. In the article, Abbate said the compensation package was inflated by cashed-out sick time, vacation time and a retirement account.</blockquote> She did even better in subsequent years, <blockquote>The Miami Beach Community Health Center’s federal tax report for 2010 indicates Abbate’s base salary was $261,165 — but includes an additional $956,584 in 'bonus and incentive' dollars that pushed her total compensation to more than $1.2 million. The center’s IRS disclosure for the prior year reported Abbate’s base salary as $970,532, and total compensation of $987,902. In 2008, Abbate’s total reported compensation was $824,686, records show.</blockquote> The CEO got very generous compensation given the size of her organization.  This compensation was documented on forms the organization submitted to the IRS that were in the public domain. However, as we have discussed many times before (look <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">here</a>), many leaders of health care organizations, including non-profit organizations, have been collecting very generous compensation. The Role of the Board of Trustees As we have discussed before, e.g., <a href="http://hcrenewal.blogspot.com/2012/05/more-rising-compensation-for-executives.html">here</a>, exceptional compensation for top hired managers is often justified by the governing boards, that is, boards of trustees or directors, to whom the hired managers nominally report.  These governing board members often seem to be working off a common set of "talking points."  In this case, there was a difference. The Herald reported that the Centers board of trustees "never agreed to pay Abbate more than $300,000, [Center Chief Medical Officer Dr Mark] Rabinowitz said." The board seemed totally unaware of what their organization was paying its CEO. <blockquote>Rabinowitz and a health center spokeswoman, Alia Faraj-Johnson, said that board members they spoke to had not seen the [2010] newspaper story [about the CEO's 2008 compensation]until just recently, and acknowledged its content would have raised significant red flags. 'That would have tripped everybody’s light,' Rabinowitz said.</blockquote>Why the board had never thought to look at the organization's own reports (990 forms) to the US Internal Revenue Service which detailed the executives' compensation, reports that were in the public domain, and are easily available online (look<a href="http://www.guidestar.org/organizations/59-1829984/miami-beach-community-health-center.aspx"> here)</a>, is unknown. The article implied that the board was somehow not up to this task even though it has fiduciary responsibilities to oversee the top hired managers, oversee the overall budget, and try to maintain both the organization's mission and fiscal stability did not seem up to the task. The article noted, <blockquote>board members remained unaware until last spring. Under federal law, at least half of the board members of federally subsidized health centers such as Miami Beach’s must be consumers of the clinic, and some of the clinic’s board members were simply ill-equipped to detect what the center calls a sophisticated financial crime.</blockquote> The board members seemed to think that it was the job of the CEO's subordinates to keep tabs on her compensation, <blockquote>'One of the sad things about this, regrettably, is that if the gatekeeper in this case, the chief financial officer, had done his job, a large portion of this would have been discovered a long time ago,' said Bill Dillon, a Tallahassee-based healthcare lawyer who is advising the center.</blockquote> The Chief Financial Officer contended that he would not have been able to successfully blow the whistle: <blockquote>[CFO Stanley] DeHart, who lives in Coral Springs, said he was aware of many of Abbate’s activities, but declined to alert the board of directors. 'The board of directors was very close to her, and I really thought they would not believe me,' DeHart said. 'They held her in very high esteem.' DeHart and members of his staff 'discussed whistle-blowing,' he said, but they all agreed taking such an action was more likely to result in their firing than Abbate’s. 'I felt at the time, and I still feel, that I had no proof that the board of directors would accept.' And, DeHart added, blame for the scandal should include outside auditors, who failed to raise any objections when Abbate wrote dozens of checks to herself for 'community development' — a department that regularly generated an enormous amount of 'abnormal activity.' DeHart said he told auditors he suspected something was amiss in the community development department. 'The external auditors had to have known about this,' DeHart said, 'because I laid it out to them in plain view. I did not hide anything.'</blockquote> In fact, the CEO's total compensation, plus a variety of other payments she seemed to direct to herself, were not made clear until <blockquote>May, after a routine audit required by federal funders turned up irregularities, said Mark Rabinowitz, an obstetrician and gynecologist who is the center’s chief medical officer. Abbate had written a check for $5,000 to herself, and cashed it, labeling the expenditure a 'community development' expense....</blockquote> Only after that, <blockquote>Calling the actions of their former administrator an 'outrageous betrayal of trust,' authorities with the Miami Beach Community Health Center are investigating what they call the theft of almost $7 million in taxpayer money by the center’s longtime chief executive. Members of the health center’s board of directors fired Chief Executive Officer Kathryn Abbate, saying she diverted the nearly $7 million in money intended to provide healthcare for the needy to her personal use beginning in 2008.</blockquote> Summary So let me backtrack a bit. The board of a moderately big, non-profit community health center seemed to make no attempt to monitor the organization's finances, did not even review the organization's own filings with the US government, and therefore had no idea what they were paying their CEO. Nonetheless, they seemed to assume that the organization's finances would be kept in order by an executive who reported to that same CEO. When an audit ordered externally ordered revealed that the CEO was being paid much more than the board had assumed, they charged "embezzlement," again even though a good chunk of such payments were in the form of compensation reported to the US government. The real distinction between this case and many other cases of huge <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a> we have discussed is that in this one the board seemed to be trying to maintain "plausible deniability" of any knowledge of the CEO's compensation, even though supervising that compensation was its direct responsibility. In other cases, board seem fully aware of enormous compensation, but blithely dismissive of any concerns about it.  So does this case could represent "embezzlement, " why were all the other cases of hired managers lavishly compensated not so regarded, even when their compensation was completely out of proportion to their known accomplishments, their organizations' financial performance, much less their organizations' fulfillment of their missions and positive impact on patients' and the public's health?  In many of those cases, the money paid out in executive compensation was also partially derived from taxpayers, and also was partially meant to "provide healthcare for the needy." As I have said many times before,...  Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

When Does Lavish Executive Compensation Become "Embezzlement?"

A single article in the Miami Herald raises the question of when is excessive executive compensation in health care too excessive. To set ...

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Old Mystery Solved? Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

At my Dec. 2005 post "<a href="http://hcrenewal.blogspot.com/2005/12/report-life-science-manufacturers.html" target="_blank">Report: Life Science Manufacturers Adapt to Industry Transition</a>" I wrote: <blockquote class="tr_bq">... The recognition of a gap in formally-trained medical informatics-trained personnel in the pharmaceutical industry [by Gartner Group] is welcome. For example, from my own experience: I recall an interview I had last year with the head of the Drug Surveillance & Adverse Events department at Merck Research Labs in a rehire situation [after a 2003 layoff]. I came highly recommended by an Executive Director in the department, to whom I had shown my prior work. This included well-accepted, novel human-computer interaction designs I'd developed for use by busy biomedical researchers for a large clinical study in the Middle East, as well as my work modeling invasive cardiology and leading the development and implementation of a <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/scotsilv/invascard.htm" target="_blank">comprehensive information system</a> to detect new device and treatment modality risks in a regional center performing more than 6,000 procedures/year. In addition, I'd worked with the wife of the Executive Director in years prior, when she ran the E.R. of the hospital where I was director of occupational medicine. Despite all this in my favor, the Executive Director's boss, himself a former FDA adverse events official [a former deputy director of CDER’s office of drug safety, who'd recently moved to the pharma industry he once regulated - ed.], dismissed me in five minutes as I was showing him the cardiology project, saying flatly "we don't need a medical informatics person here." I had driven 80 miles to Rahway for this interview to save the executive a trip to Pennsylvania, where I was originally scheduled to come for the interview, since the executive's father was ill in the hospital. In an instance of profound social ineptness, my effort was not even acknowledged. Perhaps he was in a bad frame of mind, but the dismissal under the circumstances was all the more disappointing.</blockquote> I recall this was one of the most puzzling hiring debacles I'd ever experienced, as all the senior people in his dept. had recommended he hire me - I was really only there for his approval and signoff - and the work I'd shown him had improved care, saved lives, and saved money. I may not need to be puzzled any longer.  This story just appeared: <blockquote class="tr_bq"><a href="http://truth-out.org/news/item/10524-former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety" target="_blank">Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety</a> By Martha Rosenberg, <a href="http://truth-out.org/" target="_blank">Truthout </a> July 29, 2012 The Food and Drug Administration (FDA) is often accused of serving industry at the expense of consumers. But even FDA defenders are shocked by reports this week of an institutionalized FDA spying program on its own scientists, lawmakers, reporters and academics that included an enemies list of "actors" and collaborators ... Ronald Kavanagh [FDA drug reviewer from 1998 to 2008]:  ... In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee. There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drug ... While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs.</blockquote> Read the entire story at the link.  I won't cover it more here, except to say it's certainly possible to believe certain FDA officials don't want serious people around -- who in addition to being MD's can write serious software to detect drug and device problems -- whose work can get in the way of drug approvals. -- SS

Old Mystery Solved? Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

At my Dec. 2005 post " Report: Life Science Manufacturers Adapt to Industry Transition " I wrote: ... The recognition of a gap in ...

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