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Showing posts with label Mismanagement. Show all posts
Showing posts with label Mismanagement. Show all posts

Thursday, 17 March 2016

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

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

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


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


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

and

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


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

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

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

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

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

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

Here's details from the first article:

A new $764 million medical records system is launching at the municipal hospital system on April 2 � even though insiders warn it isn�t ready and patients will suffer.

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

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

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

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

Sources say Dr. Ramanathan Raju, who runs the municipal network, NYC Health + Hospitals, is under the gun from City Hall to meet the deadline and fears he�ll be fired if he doesn�t.

�Raju has said too many times to count that the Mayor�s Office has told him if April 1st doesn�t happen, then Ram will lose his job,� one source said.

The source added that Raju has threatened to fire top executives if the project doesn�t launch on time.

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

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

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

Money for EHR's grows on trees.

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

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

One is planning for a crash, which some consider almost inevitable because the new setup hasn�t been configured to work with systems at other hospitals or with some of its own internal billing and tracking software.

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

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

�There are supposed to be all these dry runs,� a source said. �They haven�t been done.�

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

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

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

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

"No glitches?" 

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

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


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

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

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

Epic Staffing Guide 

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

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

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

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

Don�t just hire the agreeable candidate, the guide says, since it may take someone annoying to push a project along or to ask the hard but important questions that all the suck-ups will avoid. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This is exactly how patients end up maimed and dead.

Agency president Dr. Ramanathan Raju has repeatedly told colleagues his job is on the line if the deadline isn�t met, sources said.

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

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

�He [Perry] took a stand,� said one insider. �He wasn�t going to take part in something that was going to compromise patient safety.�

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

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

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

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

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

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

-- SS

What is Criminal Negligence?

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

What is Criminal Negligence?

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

What is Criminal Negligence?

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

What is Criminal Negligence?

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

What is Criminal Negligence?

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

Thursday, 24 September 2015

Princess Health and Cambridge University Hospitals Trust IT Failures: An Open Letter to Queen Elizabeth II on Repeated EHR Failures, Even After �12.7bn Wasted in Failed NHS National IT Programme. Princessiccia

Princess Health and Cambridge University Hospitals Trust IT Failures: An Open Letter to Queen Elizabeth II on Repeated EHR Failures, Even After �12.7bn Wasted in Failed NHS National IT Programme. Princessiccia

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Dear Queen Elizabeth,

I am an American citizen who has written for years about healthcare information technology mismanagement (IT malpractice), dangers to patients of this technology when faulty in healthcare, and the huge mania or bubble that has surrounded this technology in a layer of fairy tales that has cost your Kingdom's treasury, as well as that of the U.S., dearly.

Your subjects seem unable to learn from their mistakes, or learn even from free material at sites such as this, or at my academic site at Drexel University at http://cci.drexel.edu/faculty/ssilverstein/cases/.

Instead of being appropriately skeptical, they spend your citizen's money extravagantly and with abandon on grossly faulty computing.  This results in serious health care meltdowns such as I observed at my September 22, 2011 post on your now-defunct National Programme for IT in the National Health Service (NPfIT).  That post was entitled "NPfIT Programme goes 'PfffT'" and is at http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html.

In that post I observed:

... [NPfIT] also failed because of collective ignorance of these domains [e.g., healthcare informatics, social informatics, etc. - ed.] among its leaders, and among those who chose the leaders. For instance, as I wrote here:


The Department of Health has announced the two long-awaited senior management appointments for the National Programme for IT ... The Department announced in February that it was recruiting the two positions as part of a revised governance structure for handling informatics in the Department of Health.

Christine Connelly will be the first Chief Information Officer for Health and will focus on developing and delivering the Department's overall information strategy and integrating leadership across the NHS and associated bodies including NHS Connecting for Health and the NHS Information Centre for Health and Social Care.Christine Connelly was previously Chief Information Officer at Cadbury Schweppes with direct control of all IT operations and projects. She also spent over 20 years at BP where her roles included Chief of Staff for Gas, Power and Renewables, and Head of IT for both the upstream and downstream business.

Martin Bellamy will be the Director of Programme and System Delivery. He will lead NHS Connecting for Health and focus on enhancing partnerships with and within the NHS. Martin Bellamy has worked for the Department for Work and Pensions since 2003. His main role has been as CIO of the Pension Service.

Excuse me. Cadbury Schweppes (candy and drink?) The Pension Service? As national leaders for healthcare IT?

Also see my August 2010 post "Cerner's Blitzkrieg on London: Where's the RAF?" at http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html.

It's clear medical leaders in the UK learned little from the �12.7bn NPfIT debacle.  Now we have this:

Addenbrooke's Hospital consultants concerned over online records
BBC News
31 July 2015
http://www.bbc.com/news/uk-england-cambridgeshire-30393575

A �200m online patient-record system has been "fraught with problems" and medics' concerns "seemingly overlooked", senior hospital consultants have claimed.

A letter seen by the BBC reveals management at Addenbrooke's and Rosie hospitals in Cambridge were told of "serious" issues last month.  It came after the hospitals transferred 2.1 million records in October.

The trust said "unanticipated" issues led to "more than teething problems". 

The hospital is the first in the UK to use Epic's eHospital system, which is used in hospitals in the US.

To the CEO, these problems are just "hiccups":

... Chief executive Dr Keith McNeil admitted there had been "more than teething problems" and "some of it was anticipated and some of it was unanticipated". The "unanticipated" problems included problems with blood tests and "one of the busiest periods in the hospital's history", he said. He added: "We're profoundly sorry about that... people will understand that you can't do an information technology implementation of this size without some hiccups.

"Hiccups" are a euphemism for incompetence in system design, implementation and testing before it is used on live patients, Your Majesty.  I also note that a close relative of mine, and numerous other patients I know of are severely injured or dead due to these "hiccups."  

And now this:

Addenbrooke's and Rosie hospitals' patients 'put at risk'
BBC News
22 September 2015
http://www.bbc.com/news/uk-england-cambridgeshire-34317265

One of the UK's biggest NHS trusts has been placed in special measures after inspectors found it was "inadequate".

Cambridge University Hospitals Trust, which runs Addenbrooke's and the Rosie Birth Centre, was inspected by the Care Quality Commission in April and May.

Inspectors expressed concerns about staffing levels, delays in outpatient treatment and governance failings.

... Prof Sir Mike Richards, the Care Quality Commission's (CQC) chief inspector of hospitals, said while hospital staff were "extremely caring and extremely skilled", senior management had "lost their grip on some of the basics".

"[Patients] are being put at risk," he said. "It is not that we necessarily saw actual unsafe practice but we did see they would be put at risk if you don't, for example, have sufficient numbers of midwives for women in labour."

The trust, which is said to be predicting a �64m deficit this year, has apologised to patients.

I note that these hospitals had been the beta site for the first implementation of U.S. EHR maker EPIC company's product of the same name.  That �64m deficit looks a bit suspicious for IT overspend; for example see this U.S. hospital's experience of going in the red over fixing 10,000 "issues" (problems) with EPIC, in my post of June 2, 2014:  "In Fixing Those 9,553 EHR "Issues", Southern Arizona�s Largest Health Network is $28.5 Million In The Red" at http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html.

... Perhaps the most worrying aspect of the Addenbrooke's story is not that such a world-renowned hospital has ended up in a predicament like this, but rather that it happened so quickly.

A year ago the trust which runs the hospital - Cambridge University Hospitals NHS Foundation Trust - wasn't even on the Care Quality Commission's radar in terms of being a failing centre.

I suggest a deep connection between this rapid fall, and the rapid rise of an EHR - an antiquated term for what is now an enterprise command-and-control system for hospitals.

... In fact, two years ago - as the regulator was embarking on its new inspection regime - it was among the band of hospitals considered to be the safest, according to the risk-rating system at the time.

But now a hospital which can boast to being a centre of excellence for major trauma, transplants, cancer, neurosurgery, genetics and paediatrics, has been judged to be a basket case and will join the 12 other failing hospitals already placed in special measures.

In my view, a major disruptive technology such as a new EHR is the Number One suspect in such a fall.

... Certainly it seems to have made mistakes - as the troubles with its �200m computerised patient records programme illustrates - but it's hard to escape the feeling that this is just the tip of the iceberg.

The "troubles with its �200m computerised patient records programme" is likely the iceberg, not just its tip.

The Care Quality Commission ("The independent regulator of health and social care in England", http://www.cqc.org.uk/) investigated these hospitals and issued a report, located at http://www.cqc.org.uk/location/RGT01/reports.

Among their key findings were:

Introducing the new EPIC IT system for clinical records had affected the trust�s ability to report, highlight and take action on data collected on the system. 

Excuse me?   Spend �200m on a computer system, and the result is impaired ability to report, highlight and take action on data collected?  Something is very wrong here.

 ... Although it was beginning to be embedded into practice, it was still having an impact on patient care and relationships with external professionals.

Clearly, the CQC does not mean a positive impact.

... Medicines were not always prescribed correctly due to limitations of EPIC, although we were assured this was being remedied.

Spend �200m on a computer system and the result is medicine prescription impairment (with the risks to patients that entails)?  Excuse me?

If those "limitations" affect these British hospitals, what "limitations" on getting prescriptions correct exist in all the U.S.-based hospitals that use this EHR, I ask?

... There was a significant shortfall of staff in a number of areas, including critical care services and those caring for unwell patients. This often resulted in staff being moved from one area of a service to another to make up staff numbers. Although gaps left by staff moving were back-filled with bank or agency staff, this meant that services often had staff with an inappropriate skills mix and patients were being cared for by staff without training relating to their health needs.

I suspect many staff were so unhappy with the EHR that they left, and recommended others not come.

Despite this patients received excellent care.

Odd how patient care and safety is never affected by bad health IT, as in the myriad stories at this site under the indexing key "patient care has not been compromised" (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).

... Clinical staff were not always able to access the information they required � for example, diagnostic tests such as electrocardiographs (ECGs) to assess and provide care for patients. This was because ECGs had to be sent to a central scanning service to be scanned into the electronic recording system [a.k.a. EHR] once the patient had been discharged. This meant their ECGs would not be available for comparison purposes if a patient was re-admitted soon after discharge.

Very, very bad IT planning, potentially putting unstable patients at risk.  Cybernetic miracles always have "fine print" that needs be read by skeptical managers BEFORE implementation.

Where agency staff were used, they were not always able to access information about patients they were supporting. 

 Ditto.

... Some staff told us there were no care plans on the new IT system.  Some staff told us the doctors� orders had replaced care plans on the new EPIC IT system. These orders were task-orientated and did not always reflect the holistic needs of the patients.

This defective arrangement sounds like it was designed by non-clinicians.   The hubris and arrogance of non-clinicians sticking their heads into clinical issues - especially those of an IT-management background - must be witnessed to be fully comprehended.  It is my belief that such individuals should be subject to the liability as are the clinicians whose work increasingly depends on these IT systems.   If you dare to stick your neck into clinical affairs regarding systems upon which clinicians depend, you should be subject to the same liabilities as a clinician.  Unfortunately, this rarely if ever occurs.

 ... Whilst there were up-to-date evidence-based guidelines in place, we were concerned that these were not always being followed in maternity. This included FHR monitoring, VTE and early warning score guidelines. Staff were competent and understood the guidelines they were required to follow, however, lack of staffing and familiarity with the computer system (EPIC) made this difficult.

The point being missed here is that paper records required no massive multi-hundred page training manual in order to to perform basic functions such as the above.  The complexity of EHRs is costly, unnecessary, impairs clinicians and the solution is a massive scale back and simplification of these systems' complexity and scope.  Unfortunately, that, too is unlike to happen until the negative impacts become increasingly visible and intolerable - a meltdown I predict will occur, eventually.

... Since the introduction of EPIC, outcomes of people�s care and treatment was not robustly collected or monitored. For example, there was no maternity dashboard available since December 2014.

Again, spend �200m and have this result?  Something is seriously wrong here.  I suspect it is that personnel no longer had the time to perform monitoring, as they were likely distracted and struggling to keep afloat with more fundamental medical issues (like keeping major mishaps from occurring) using a complex and buggy EHR system.

That theory is likely confirmed by the following:

... At unit level we observed examples of excellent leadership principles; however, leadership of the directorate overall required improvement. This was because senior managers had not responded appropriately or in a timely way to known and serious safety risks, there was a general lack of service planning, and because key performance data was not being collected robustly and therefore not being analysed. We recognised that EPIC was the root cause of the problems with data collection, and that prior to its introduction in October 2014 many of the data collection issues were not apparent, however, improving this issue was not seen as a priority.

Management, I suspect, became complacent due to their infatuation with cybernetics and a belief that with a big-name EHR in place, operational ills were accounted for and they could relax.  (I've written of this phenomenon as the "syndrome of inappropriate overconfidence in computing.")  Management complacency, bad health IT and struggling clinicians is a very, very bad combination.

... Staff understood their responsibilities for safeguarding children, and acted to protect them from the risk of avoidable harm or abuse. There were enough medical staff but there were nursing shortages in some areas, such as in the day unit and in the neonatal unit. The new �EPIC� (a records management system) computer system added to pressures on staff but effective temporary solutions helped to protect patients.

In other words, workarounds were used to get around the work-impeding EHR.  Workarounds introduce yet more risk.

... the electronic records system (EPIC) created significant numbers of delayed discharges that impacted on patients receiving end-of-life care.  ... Many staff said they had struggled with EPIC and it was time consuming. The specialist palliative care team found patients dropped off the system, so kept two lists to avoid losing patients.

One does not struggle with paper records.  (My current colleagues tell me the EHR struggle is non-ending.)  I further note that a computer system's rights, it appears, took precedence over patients' dying with dignity.

... While introducing EPIC, processes to deal with remaining paper records were unclear. For example, staff documented follow-up appointment requests on notepads. Paper records which were not stored in EPIC were inconsistently stored within the outpatients department. Inaccurate discharge summaries led to a risk that patients would not receive appropriate follow up care.

A fetish to totally eliminate paper, even where paper is the best medium for a purpose (e.g., as here:  http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story), creates major chaos and increases risk.

In conclusion, Your Highness, it might benefit your citizens (and those of the U.S.) if a national re-education programme were instituted to de-condition your leaders from unfettered belief in cybernetic miracles in medicine, a mental state they attain in large part due to mass EHR vendor and pundit propaganda.

A more sober mindset is recommended by your subject Shaun Goldfinch in "Pessimism, Computer Failure, and Information Systems Development in the Public Sector" (Public Administration Review 67;5:917-929, Sept/Oct. 2007, then at the University of Otago, New Zealand): 

The majority of information systems developments are unsuccessful. The larger the development, the more likely it will be unsuccessful. Despite the persistence of this problem for decades and the expenditure of vast sums of money, computer failure has received surprisingly little attention in the public administration literature. This article outlines the problems of enthusiasm and the problems of control, as well as the overwhelming complexity, that make the failure of large developments almost inevitable. Rather than the positive view found in much of the public administration literature, the author suggests a pessimism when it comes to information systems development. Aims for information technology should be modest ones, and in many cases, the risks, uncertainties, and probability of failure mean that new investments in technology are not justified. The author argues for a public official as a recalcitrant, suspicious, and skeptical adopter of IT.

Such a mindset would be helpful in preventing massive wastes of healthcare Pounds, Euros and Dollars better spent on patient care than on cybernetic pipe dreams.

Sincerely,

S. Silverstein, MD
Drexel University
Philadelphia, PA

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

Addendum:

I would like to hear from those in the know if my suspicions are correct.  Please leave comments.

-- SS

    Friday, 21 March 2008

    Princess Health and Who Was Responsible for the Purity of Baxter International's Heparin?. Princessiccia

    Princess Health and Who Was Responsible for the Purity of Baxter International's Heparin?. Princessiccia

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    We have posted several times, most recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.

    All the heparin related to these events was made by Baxter International. We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. In fact, the company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.)

    It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there. The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

    By the end of this week, it became clear that the counterfeit ingredient was added to the heparin in China. Per Bloomberg,



    The contamination was present in the powdered raw heparin purchased by Scientific Protein's plant in China, said Robert Rhoades, a pharmaceutical consultant with Becker & Associates in Washington, speaking for Scientific Protein. The company was unaware of the contamination at the time because it wasn't detected in tests Scientific Protein conducted on the powder provided by suppliers, he said.

    Scientific Protein purchased raw heparin from consolidators and refined it further before sending it to Baxter, which uses the ingredient to make the finished drug, Rhoades said. The consolidators obtained the ingredients from workshops in China, he said.

    The contaminant 'was very likely introduced at the workshop or consolidator level,' Norbert Riedel, Baxter's corporate vice president and chief scientific officer, has said.


    Nonetheless, a number of experts suggested that there was reason not be complacent about drugs made in China. A Washington Post article noted that it was well known that Chinese manufacturers were liable to supply dodgy drugs,



    Although the contaminated heparin is the largest and highest-profile instance of tainted prescription drugs made in China, it is not the first. In the late 1990s, a spike in deaths associated with the intravenous antibiotic gentamicin was linked to China-based Long March Pharmaceuticals. Although no definitive link was ever established, tests by German researchers later found a wide range in quality and effectiveness in what were supposed to be uniform dosages of the drug, leading them to write that 'it was assumed' the deaths 'were related to faulty manufacture.'

    The Post quoted former US Food and Drug Administration (FDA) official William Hubbard,



    The history of some of these developing countries in terms of substituting or counterfeiting concerns is a long and well-documented one....

    USA Today quoted former FDA Commissioner David Kessler saying that



    the news shouldn't come as a surprise: China is 'as close to an unregulated environment as you can get.' In fact, it's a lot like the USA was in 1906, he says �'that's why we developed an FDA.'

    Furthermore, one expert argued that Baxter International was ultimately responsible for the drug that it sold, per the Chicago Tribune,



    The presence of a foreign ingredient raises new questions about Baxter's oversight because a lack of record-keeping at the China plant makes it more difficult for Baxter and government inspectors to trace the origin of the raw material for Baxter's product.

    'Where are the controls here? What is the process here?' asked Carl Nielsen, who was the FDA's director of import operations and policy before leaving the agency to form a consulting firm in 2005.

    'Ultimately, Baxter is the most responsible' for monitoring the quality of products that move through the company's pipeline, Nielsen said.


    Yet Baxter International executives have not exactly been jumping forward to claim responsibility. In a letter, again to the Chicago Tribune, Peter J Arduini, President, Medication Delivery, for Baxter International seemed to be deflecting responsibility towards Scientific Protein Laboratories and the FDA, while asserting Baxter did all it could do.

    Regarding the issue of active pharmaceutical ingredient that originated in China, Baxter's API supplier for heparin is in fact a Wisconsin-based company, Scientific Protein Laboratories, with whom Baxter and its predecessor in this business has worked for more than 30 years. SPL had been procuring heparin raw material from China for more than 10 years and opened a location in Changzhou, China, in 2004. Baxter worked with the U.S. Food and Drug Administration to obtain the appropriate approvals to work with this facility. For the API we receive from SPL, and for the API we receive from all our suppliers, Baxter performs quality testing of all incoming materials above and beyond what's required, to ensure that incoming API is what our suppliers claim it to be. Unfortunately, as the FDA has said, the problematic heparin API could not have been detected by the testing required of and done by any heparin manufacturer.
    Previously Baxter International's CEO, Robert L Parkinson Jr, had dodged responsibility for the supply chain that provided the heparin to Scientific Protein Research's Changzhou facility, as we posted here, and as originally reported in the Chicago Tribune,

    Baxter International Inc. does not monitor its supply chain to the extent that it would know that a supplier in China was never inspected before it began shipment of the blood-thinning drug heparin, which is linked to more than 300 illnesses in the U.S., the company's chief executive said Wednesday.

    Baxter contracted with a Wisconsin supplier, Scientific Protein Laboratories, and not with that company's Chinese affiliate, Baxter CEO Robert Parkinson said Wednesday in his first interview since the heparin problems surfaced.

    'It's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier,' Parkinson said.


    Yet if Baxter International is not responsible for the production of drugs that carry its name, who is? If Baxter International's executives are not responsible for how the drugs it sells are manufactured, who should be?

    In an ironic juxtaposition, a small and little noticed news item last week declared that Robert Parkinson received $16,600,000 in compensation in 2007, a 30.5% increase from 2006. In fact, the company's 2008 proxy statement suggests even greater total compensation in 2007, $17,580,718. And Mr Arduini's 2007 compensation was reported to be $2,438,642.

    The usual justification for compensation at this level is the brilliance of and great responsibilities borne by the executives who receive it. But, if Baxter International's executives will not take responsibility for their products and how they are made, what again is the justification for paying them the big bucks?

    So the case of the contaminated heparin becomes another reason to question the imperial nature of the current leadership of health care organizations.

    Wednesday, 19 March 2008

    Princess Health and Fake Heparin, then Sick and Dead Patients. Princessiccia

    Princess Health and Fake Heparin, then Sick and Dead Patients. Princessiccia

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    We have posted several times, most recently here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions. All the heparin related to these events was made by Baxter International.

    We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. In fact, the company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.

    It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there. The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

    Now the US FDA just reported it identified a contaminant in the heparin that may be responsible for the adverse reactions. This has already been reported today by many media outlets, but I will quote Bloomberg since its article makes the main points most concisely,


    Baxter International Inc.'s blood thinner heparin, linked to deaths and allergic reactions, was contaminated with a less-expensive ingredient derived from animal cartilage, U.S. regulators said.

    The contaminant, over-sulfated chondroitin sulfate, isn't approved for use in medicine, said Janet Woodcock, the head of the Food and Drug Administration's drug division, in a conference call today with reporters. Regulators are investigating whether the substance was intentionally or accidentally added to raw heparin from China.

    'It does not appear to have come straight from the pig,' Woodcock said of the contaminant. 'It doesn't appear to be a natural contaminant that got in there. We don't know how it was introduced or why.'

    Adding the contaminant to raw heparin, the active ingredient in the finished product, would have been cheaper than using pure raw heparin, according to the FDA. The agency didn't know how much money would be saved by its use, Woodcock said.

    Chondroitin sulfate is taken orally as a dietary supplement to treat joint pain. The over-sulfated version found in the heparin was chemically modified to act like heparin, Woodcock said.

    Over-sulfated chondroitin sulfate is generated in laboratories for experimental purposes, said Siobhan DeLancey, an FDA spokeswoman, in an interview. It is chemically altered to add additional sulfates, she said.

    Two percent to 50 percent of the contaminated raw heparin samples tested by the FDA were made up of over-sulfated chondroitin sulfate, Woodcock said.


    So it now appears, although it is not yet proven that the adverse reactions and deaths were caused not by a trace contaminant derived from a sloppy, primitive, and unsanitary manufacturing process, but from a bulk counterfeit ingredient deliberately introduced because it was cheaper than heparin, yet would fool purchasers into thinking it was heparin.

    Thus we see what happens when US health care leaders were happy to put their prestigious logo on a drug whose source was unknown to them, presumably just to save some money. By obviously failing to exert rigorous oversight over how the drug which carried their company's name was produced, they not only allowed sloppy, primitive and unsanitary manufacturing practices, but apparently were easily snookered by counterfeiters who substituted a likely toxic ingredient for the real thing.

    This was putting profits before patients. And the results were very bad for patients.

    Baxter claims to apply
    its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

    However, rather than its expertise, its sloppy and uncaring leadership seemed to leave some of its patients' lives meaningfully worse.

    This case is a glaring demonstration of why we need a new set of leaders of our health care organizations, and a new corporate culture within these organizations. Otherwise, failing to understand the health care context, and failing to put patients before profits will yield more sick and dead patients.

    Saturday, 1 March 2008

    Princess Health and Heparin in an Era of Hogwash. Princessiccia

    Princess Health and Heparin in an Era of Hogwash. Princessiccia

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    Two weeks ago we first posted about an emerging scandal about the production of the drug heparin, a biologic that has been in use for over 70 years. First, we posted about the sudden increase in the frequency and severity of adverse effects due to heparin that carried the Baxter International label. However, its "active ingredient," that is, the heparin itself, was purchased from Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Furthermore, it turns out that the factory was never inspected by either the US Food and Drug Administration (FDA) or its Chinese counterpart.

    Last week, we posted about how the CEOs of Baxter International and Scientific Protein Laboratories did not seem aware of the origin of the heparin for which they were ostensibly responsible. Furthermore, it turns out its origin was not just Changzhou SPL, but a series of small, unregulated Chinese factories.

    Since then, the plot has continued to thicken.

    A congressional investigation is starting. Per the Wall Street Journal,



    congressmen asked whether Baxter had known the Chinese plant hadn't been inspected and suggested the company might therefore be distributing an unapproved drug.

    In a separate letter to HHS Secretary Michael O. Leavitt, the lawmakers asked for records relating to the FDA's preapproval inspection policy. They also sought an explanation of the agency's interpretation of the legal status of drugs shipped into 'United States commerce by a drug company that knew or should have known that FDA had not performed a preapproval inspection, as is alleged in the Heparin case.'

    Chinese regulators dodged any responsibility. Again, per the Wall Street Journal,


    China's drug-safety agency, responding to questions about oversight of an exported blood-thinning compound, said checks of pharmaceutical ingredients made in China are ultimately the responsibility of countries that buy them.

    The State Food and Drug Administration said it works with foreign counterparts to monitor drug-ingredient production. But it said that based on international practice, 'safeguarding the legality, quality and safety of active pharmaceutical ingredients' is up to importing countries.


    The supply chain of heparin in China appears to be even more difficult to trace than previously reported. An investigative report published in the NY Times, first quoted the CEO of Scientific Protein Laboratories, Mr David Stunce, "we have a collection chain in place, and we stick with that." However,



    But interviews with dozens of heparin producers and traders in several Chinese provinces, as well as a visit to a village near here dominated by tiny family workshops that process crude heparin from pig intestines, show the difficulties confronting investigators as they seek to trace the supply chain. The picture that emerges is of a chain more complex, and less orderly, than the one Mr. Strunce laid out.

    The Chinese heparin market has become increasingly unsettled over the last year, as pig disease has swept through the country, depleting stocks, leading some farmers to sell sick pigs into the market and forcing heparin producers to scramble for new sources of raw material. Traders and industry experts say even big companies have been turning more often to the small village workshops, which are unregulated and often unsanitary.

    One of the wholesalers named by Scientific Protein Laboratories, Ruihua Biochemical in Hangzhou, said it provided a mix of crude heparin that it manufactured and some that it bought 'from small factories nearby in several villages.' The owner, Hua Ruihua, said he never inspected the small factories. 'We are not the government,' he said in a telephone interview. 'We have no right to inspect their pigs or intestines or facilities.'

    The owner of one of those workshops, Fan Yinan, said, I sold to Ruihua several times before, but since last September I have had no intestines.' He confirmed that 'no one from Ruihua inspected my pigs or intestines.'


    Strunce's response was this non-denial denial, "we have no information to suggest your information is true."

    Some heparin is produced in primitive and unsanitary conditions. The Times reporters also visited some small factories, whose operations do not exactly inspire confidence in the safety and purity of their products.



    Some experts say as much as 70 percent of China�s crude heparin � for domestic use and for export � comes from small factories in poor villages. One of the biggest areas for these workshops is here in coastal Jiangsu Province, north of Shanghai, where entire villages have become heparin production centers.

    In a village called Xinwangzhuang, nearly every house along a narrow street doubles as a tiny heparin operation, where teams of four to eight women wearing aprons and white boots wash, splice, separate and process pig intestines into sausage casings and crude heparin.

    The floors had large puddles and drainage channels; the workshops were dilapidated and unheated; and steam from the production process fogged up the windows and soaked the walls. There were large ovens to cook ingredients and halls lined with barrels to store enzymes, resins, intestines and wastewater.

    'This is our family-style workshop,' said Zhu Jinlan, the owner of one heparin operation, who stopped sorting pig intestines and invited visitors to a back room, where she lives with her husband and child. 'We�ve been doing this about 10 years.'

    Experts say the small, unregulated factories could pose dangers because they do not have the same controls and rules as large slaughterhouses, which also produce crude heparin.

    'If you don�t control the incoming source, it�s very hard to get rid of the contaminants,' says Liu Jian, a heparin expert at the University of North Carolina.

    Mr. Strunce of S.P.L. says his company never buys directly from the crude-heparin producers, only through its wholesalers, which he called 'consolidators' � Changzhou Techpool, its Chinese joint venture partner, and Ruihua. His company, he said, has records documenting all the transactions.

    But here in Rugao, producers of crude heparin tell a somewhat different story. A sales manager for a major supplier, Nantong Koulong, said he sells directly to S.P.L. without going through either of the two wholesalers. 'We provided crude heparin to Changzhou SPL,' said the sales manager, Chen Jianjun. Some of Koulong�s stock comes from the unregulated workshops, he said.

    The owner of one such workshop, Ms. Zhu in Xinwangzhuang, said she sold to S.P.L. two years ago. She also sells to Koulong. 'We are really a traditional family-style plant,' she said. 'We have no certificate.'

    S.P.L. said it never bought directly or indirectly from Koulong.

    The large companies cared more about getting heparin cheap than about where it came from. Again, according to the NY Times,


    After an outbreak of blue ear pig disease swept through 25 of China�s 31 provinces and regions last year, prices soared, and many drug suppliers had to look to the small workshops. The epidemic, said Cui Huifei, a heparin expert at the Shandong University School of Medicine, 'made those biotech companies inevitably purchase from the family-style plants, for cheaper prices'

    A sales manager for another large slaughterhouse in Shandong Province, north of Jiangsu, said he was approached late last year by a buyer for S.P.L. offering what he described as rock-bottom prices for crude heparin.

    'It was impossible,' said the sales manager, Wang Shengfu, who works for Shandong Jinluo Group, a major producer of crude heparin. 'Only small factory-style farms could accept that low price.'

    The deal was never consummated.

    Wherever it gets its heparin, there were problems in the Changzhou SPL Plant. US Food and Drug Administration (FDA) inspectors finally got to the Changzhou SPL plant, and here is what they found, according to the Wall Street Journal,



    Food and Drug Administration inspectors found problems at a Chinese plant that made most of the active ingredient for Baxter International Inc.'s blood thinner heparin, but the agency still hasn't pinpointed a cause for hundreds of bad reactions in people who took the drug.

    Among other findings, the FDA said investigators found lapses in the Changzhou, China, manufacturer's quality-control procedures and the way it assessed its own efforts to remove impurities from raw materials.

    The FDA also said yesterday it was seeking to examine upstream consolidators and small workshops that supplied raw material to the Changzhou factory. FDA inspectors found in its inspection report that some heparin sold in the U.S. included 'material from an unacceptable workshop vendor.'

    Baxter International has recalled nearly all its extant heparin products, as reported in the WSJ article above.

    Finally, the toll of serious adverse events linked to heparin has increased to 448, possibly including as many as 21 deaths. (See the same article.)

    Health Care Renewal has documented numerous cases of financial mismanagement by leaders of health care organizations. We have discussed misleading marketing by drug, biotechnology and device companies, and by hospitals, academic medical centers, and health insurance companies. We have noted how medical education has been twisted into marketing, and clinical science has been manipulated, aided by pervasive conflicts of interest affecting physicians, academics, and various not-for-profit organizations.

    But through all that, even I thought that the purity of the drug supply remained sacrosanct. Even I thought that no US or major multinational pharmaceutical or biotechnology company would sacrifice the purity and quality of the drugs they sold to cut their costs.

    I may have thought that over-the-top marketing and shoddy research had inflated the benefit/ harm ratio of many drugs and devices. Up to now, however, I never doubted the purity of an FDA approved drug sold in the US with the logo of a reputable drug or biotechnology company.

    In my previous academic life in which I spent a fair chunk of my time as an academic hospitalist, I often oversaw the use of parenteral heparin. I never would have suspected that the raw material in a vial of Baxter heparin came from some primitive, unsanitary, uninspected "family style" workshop in China.

    We have reached a new low in US health care. The system is now mired in muck. We need a new generation of muck-rakers to clean it out. We need a total overhaul of the management of US health care organizations. We need managers who once again put patients before profits, and before lining their own pockets. Until things change, more people will die, and we will all eventually drown in the hogwash.

    Monday, 20 June 2005

    Princess Health and "We'll Manage It the Way We Damn Well Want". Princessiccia

    Princess Health and "We'll Manage It the Way We Damn Well Want". Princessiccia

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    Phoebe Putney Health System is a health care system in Georgia, which boasts of "world-class medicine, hometown commitment." Its stated core values include "people come first," and "relationships are built on honesty and integrity."
    Pheobe Putney was the subject of federal lawsuits, now dismissed, and state lawsuits alleging that it over-charged uninsured patients. It is one of the hospital systems that is now subject of congressional investigations of the not-for-profit status of hospitals and health systems. (See news article here.)
    Now, the Atlanta Journal-Constitution has reported that top Phoebe Putney executives have run up lavish travel expenses for trips related to a for-profit subsidy. Pheobe Putney set up Grove Pointe Indemnity, based in the Cayman Islands, to provide the system with malpractice insurance. Top Phoebe Putney executives traveled to the Caymans, the Bahamas, and London, UK for Grove Pointe meetings. All travel was by private jet or first class on commercial airliners. Travel expenses included Cuban cigars, ($258 worth for one meal in London meeting), expensive beverages ($538 for one meal), and high-end accomodations (e.g., rooms at the Ritz in London, at 355 pounds sterling a night).
    The Journal-Constitution asked Phoebe Putney Chief Financial Officer (CFO) Kerry Loudermilk about these expenses. Loudermilk first said what is lavish "is in the eye of the beholder." He responded to further questions about Grove Pointe, "We own it. We'll manage it the way we damn well want." A search of the GuideStar site for Pheobe Putney's 2002 Internal Revenue Service form 990 revealed that Grove Pointe had an income just under $2.5 million, and a total loss of just over $1.25 million in that year. Meanwhile, Loudermilk's total compensation was just under $3oo,ooo. He was one of eight executives who made more than $200,ooo. Three made over $300,000, and the system's CEO made nearly $600,000.
    It will be interesting to see what the congressional investigation discovers about Phoebe Putney. Meanwhile, Loudermilk's response suggests that maybe the hired managers of this not-for-profit health care system feel a bit more ownership of it than they are entitled to. Although Pheobe Putney clearly owns Grove Pointe Indemnity, the managers of a not-for-profit do not own the organization. They should be running the organization in accord with its mission to benefit the public, which may not necessarily be the way they "damn well want." It's not clear that this job entitles them to smoke Cuban cigars on the health system's budget.
    Princess Health and "We'll Manage It the Way We Damn Well Want".Princessiccia

    Princess Health and "We'll Manage It the Way We Damn Well Want".Princessiccia

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    Phoebe Putney Health System is a health care system in Georgia, which boasts of "world-class medicine, hometown commitment." Its stated core values include "people come first," and "relationships are built on honesty and integrity."
    Pheobe Putney was the subject of federal lawsuits, now dismissed, and state lawsuits alleging that it over-charged uninsured patients. It is one of the hospital systems that is now subject of congressional investigations of the not-for-profit status of hospitals and health systems. (See news article here.)
    Now, the Atlanta Journal-Constitution has reported that top Phoebe Putney executives have run up lavish travel expenses for trips related to a for-profit subsidy. Pheobe Putney set up Grove Pointe Indemnity, based in the Cayman Islands, to provide the system with malpractice insurance. Top Phoebe Putney executives traveled to the Caymans, the Bahamas, and London, UK for Grove Pointe meetings. All travel was by private jet or first class on commercial airliners. Travel expenses included Cuban cigars, ($258 worth for one meal in London meeting), expensive beverages ($538 for one meal), and high-end accomodations (e.g., rooms at the Ritz in London, at 355 pounds sterling a night).
    The Journal-Constitution asked Phoebe Putney Chief Financial Officer (CFO) Kerry Loudermilk about these expenses. Loudermilk first said what is lavish "is in the eye of the beholder." He responded to further questions about Grove Pointe, "We own it. We'll manage it the way we damn well want." A search of the GuideStar site for Pheobe Putney's 2002 Internal Revenue Service form 990 revealed that Grove Pointe had an income just under $2.5 million, and a total loss of just over $1.25 million in that year. Meanwhile, Loudermilk's total compensation was just under $3oo,ooo. He was one of eight executives who made more than $200,ooo. Three made over $300,000, and the system's CEO made nearly $600,000.
    It will be interesting to see what the congressional investigation discovers about Phoebe Putney. Meanwhile, Loudermilk's response suggests that maybe the hired managers of this not-for-profit health care system feel a bit more ownership of it than they are entitled to. Although Pheobe Putney clearly owns Grove Pointe Indemnity, the managers of a not-for-profit do not own the organization. They should be running the organization in accord with its mission to benefit the public, which may not necessarily be the way they "damn well want." It's not clear that this job entitles them to smoke Cuban cigars on the health system's budget.

    Friday, 17 June 2005

    Princess Health and "Slippery As Oiled Pigs". Princessiccia

    Princess Health and "Slippery As Oiled Pigs". Princessiccia

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    The Washington Post followed up on the case of the hospitals that employed used elevator hydraulic fluid rather than detergent to attempt to sterilize surgical instruments. The paper reported comments by the CEO of Duke University Health System, Dr. Victor Dzau. To explain why it took so long for administrators to figure out there was something wrong with the sterilization process, he noted that normally a lubricant is applied to surgical instruments to "make sure they don't develop rust and lock up during surgery." So, "it took us a while to figure out that this was beyond the normal level of oiliness."
    Futhermore, Dzau discounted the potential health risks of the exposure, "while we understand that some patients have experience symptoms following their surgeries, everything we know would suggest that no causal connection has been established between any of the these patients outcomes and instruments exposed to the fluid in the presterilization process."
    Meanwhile, this case has attracted considerable media attention, most not very flattering to Duke. A local commentator wrote in the News Observer, "what galls most is not the mistake, but the post-mistake arrogance of hospital officials. Hospital regulators accused them of ignoring clear, early distress signals being sent by staff members who knew the instruments weren't supposed to be as slippery as oiled pigs and leave a yellow residue."
    Unfortunately, Dzau's remarks did not convince me otherwise. Surgical instruments are made of alloys that do not corrode easily, and its implausible that more than tiny amounts of oil are normally used in their sterilization. Although I am not a surgeon, I have seen plenty of sterilized instruments, and none of them were oily. Hence, if the instruments were really as "slippery as oiled pigs," anyone familiar with the operating room context should have identified this as a big problem.
    Furthermore, Dzau's comment about causality is, while probably true, not helpful. The only way to establish that exposure to operating room instruments coated with used elevator hydraulic fluid causes particular health problems would be a controlled trial that randomized some patients to such an exposure. Such a controlled trial would clearly be unethical, and I am sure no previous trial has been done. Yet in the absence of such ultimate proof, it seems reasonable to assume that it is not a good for patients to expose them to surgical instruments washed with used hydraulic fluid.
    A more productive approach would require investigating why adminstrators did not identify the oily instruments as a problem sooner.
    Princess Health and "Slippery As Oiled Pigs".Princessiccia

    Princess Health and "Slippery As Oiled Pigs".Princessiccia

    Add Comment
    The Washington Post followed up on the case of the hospitals that employed used elevator hydraulic fluid rather than detergent to attempt to sterilize surgical instruments. The paper reported comments by the CEO of Duke University Health System, Dr. Victor Dzau. To explain why it took so long for administrators to figure out there was something wrong with the sterilization process, he noted that normally a lubricant is applied to surgical instruments to "make sure they don't develop rust and lock up during surgery." So, "it took us a while to figure out that this was beyond the normal level of oiliness."
    Futhermore, Dzau discounted the potential health risks of the exposure, "while we understand that some patients have experience symptoms following their surgeries, everything we know would suggest that no causal connection has been established between any of the these patients outcomes and instruments exposed to the fluid in the presterilization process."
    Meanwhile, this case has attracted considerable media attention, most not very flattering to Duke. A local commentator wrote in the News Observer, "what galls most is not the mistake, but the post-mistake arrogance of hospital officials. Hospital regulators accused them of ignoring clear, early distress signals being sent by staff members who knew the instruments weren't supposed to be as slippery as oiled pigs and leave a yellow residue."
    Unfortunately, Dzau's remarks did not convince me otherwise. Surgical instruments are made of alloys that do not corrode easily, and its implausible that more than tiny amounts of oil are normally used in their sterilization. Although I am not a surgeon, I have seen plenty of sterilized instruments, and none of them were oily. Hence, if the instruments were really as "slippery as oiled pigs," anyone familiar with the operating room context should have identified this as a big problem.
    Furthermore, Dzau's comment about causality is, while probably true, not helpful. The only way to establish that exposure to operating room instruments coated with used elevator hydraulic fluid causes particular health problems would be a controlled trial that randomized some patients to such an exposure. Such a controlled trial would clearly be unethical, and I am sure no previous trial has been done. Yet in the absence of such ultimate proof, it seems reasonable to assume that it is not a good for patients to expose them to surgical instruments washed with used hydraulic fluid.
    A more productive approach would require investigating why adminstrators did not identify the oily instruments as a problem sooner.
    Princess Health and Nursing Home Administrator Charged with Patient Neglect. Princessiccia

    Princess Health and Nursing Home Administrator Charged with Patient Neglect. Princessiccia

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    Our local Providence Journal has been following a tragic story of the closing of a large local nursing home, after many reports of sub-standard care and financial difficulties. Today the paper reported that the former administrator of the nursing home, James D. Janetakos, has been charged by the state Attorney General with 11 counts of patient neglect, a felony.
    Noteworthy is that this charge has usually been made against health care professionals, not managers. According to the Journal, "this is the first time in recent years that a top administrator has faced charges of patient neglect."
    Law enforcement seems to be recognizing that mismanagement of health care organization may have serious effects on patient outcomes. I suspect many doctors, nurses, and other health professionals have know that intuitively for a while, but have rarely been in a position to act on that knowledge. And the concept seems still largely foreign to the health services research literature and in "health policy" circles, as best as I can tell (but I would love to be proven wrong on that, if anyone can do so.)
    Princess Health and Nursing Home Administrator Charged with Patient Neglect.Princessiccia

    Princess Health and Nursing Home Administrator Charged with Patient Neglect.Princessiccia

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    Our local Providence Journal has been following a tragic story of the closing of a large local nursing home, after many reports of sub-standard care and financial difficulties. Today the paper reported that the former administrator of the nursing home, James D. Janetakos, has been charged by the state Attorney General with 11 counts of patient neglect, a felony.
    Noteworthy is that this charge has usually been made against health care professionals, not managers. According to the Journal, "this is the first time in recent years that a top administrator has faced charges of patient neglect."
    Law enforcement seems to be recognizing that mismanagement of health care organization may have serious effects on patient outcomes. I suspect many doctors, nurses, and other health professionals have know that intuitively for a while, but have rarely been in a position to act on that knowledge. And the concept seems still largely foreign to the health services research literature and in "health policy" circles, as best as I can tell (but I would love to be proven wrong on that, if anyone can do so.)

    Monday, 13 June 2005

    Princess Health and Big Conflicts of Interest Alleged at Small Massachusetts Hospital. Princessiccia

    Princess Health and Big Conflicts of Interest Alleged at Small Massachusetts Hospital. Princessiccia

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    The Boston Globe reported on the travails of tiny Hubbard Regional Hospital in Webster, MA, allegedly brought on by mismanagement.
    The 76-year old, 24-bed hospital was run for over 10 years by Quorum Helath Resources, which says it "provides management support services, consulting, education and training programs to independent hospitals and health systems nationwide." Quorum billed the hospital $500,000 a year for its services. The hospital lost money in nine of the last 10 years.

    The Globe article suggests that the hospital's management during this time suffered from important conflicts of interest:
    • In 2003, the hospital sold a medical office building for $450,000 to a real-estate company owned by three directors of Hometown Bank. The Bank was a major creditor of the hospital. The bank's CEO, Matthew S. Sosik, was on the hospital's board of directors. The hospital leased back space in the building, but allegedly paid $3250/month for 3000 square feet while it was only using 1200.
    • In 2004, the hospital sold a house for $250,000 to a real estate trust controlled by Daniel B. Flynn, a real estate developer, who was also a borrower from Hometown Bank. Legal work for Flynn was handled by Michael L. Jalbert's law firm. Jalbert was the hospital's board chairman. Again, the hospital leased back the property at $1700/month.
    • In 2001, Flynn had leased land from the hospital for $2000/month, and built a building on it in which the hospital rented space for $7500/month. The firm that surveyed this property was owned by Jalbert's father.
    • Jalbert's law firm also handled legal work for the hospital, at the same time he handled legal work for Hometown Savings, and another hospital creditor.
    Last year, the hospital's entire board resigned. A new board terminated Quorum's contract, and hired Christopher Rich, a lawyer, to be the new CEO. Rich had no experience in health care. Among his early decisions were hiring Joseph J. LaFratta as security director, and Arnold E. Benson as chief operating officer for th hospital. He had to fire LaFratta when it became public that LaFratta was convicted in 2000 of stealing $42,000 in donations from Tufts University School of Medicine. Rich admitted the decision to hire LaFratta was "very stupid." Benson is still working, even though it turned out he had pled guilty of tax evasion in 2001. Rich's comment was "why not give Arnie a second chance?"
    One former Hubbard nurse, who was born in the hospital, called the events "a slap in the face." A member of the Hubbard Regional Hospital Guild, an auxiliary fund-raising organization, was more graphic, "The hospital was gradually being raped by various entitities."
    Even small community hospitals in the US are not safe from leadership by the inept and the conflicted.
    Princess Health and Big Conflicts of Interest Alleged at Small Massachusetts Hospital.Princessiccia

    Princess Health and Big Conflicts of Interest Alleged at Small Massachusetts Hospital.Princessiccia

    Add Comment
    The Boston Globe reported on the travails of tiny Hubbard Regional Hospital in Webster, MA, allegedly brought on by mismanagement.
    The 76-year old, 24-bed hospital was run for over 10 years by Quorum Helath Resources, which says it "provides management support services, consulting, education and training programs to independent hospitals and health systems nationwide." Quorum billed the hospital $500,000 a year for its services. The hospital lost money in nine of the last 10 years.

    The Globe article suggests that the hospital's management during this time suffered from important conflicts of interest:
    • In 2003, the hospital sold a medical office building for $450,000 to a real-estate company owned by three directors of Hometown Bank. The Bank was a major creditor of the hospital. The bank's CEO, Matthew S. Sosik, was on the hospital's board of directors. The hospital leased back space in the building, but allegedly paid $3250/month for 3000 square feet while it was only using 1200.
    • In 2004, the hospital sold a house for $250,000 to a real estate trust controlled by Daniel B. Flynn, a real estate developer, who was also a borrower from Hometown Bank. Legal work for Flynn was handled by Michael L. Jalbert's law firm. Jalbert was the hospital's board chairman. Again, the hospital leased back the property at $1700/month.
    • In 2001, Flynn had leased land from the hospital for $2000/month, and built a building on it in which the hospital rented space for $7500/month. The firm that surveyed this property was owned by Jalbert's father.
    • Jalbert's law firm also handled legal work for the hospital, at the same time he handled legal work for Hometown Savings, and another hospital creditor.
    Last year, the hospital's entire board resigned. A new board terminated Quorum's contract, and hired Christopher Rich, a lawyer, to be the new CEO. Rich had no experience in health care. Among his early decisions were hiring Joseph J. LaFratta as security director, and Arnold E. Benson as chief operating officer for th hospital. He had to fire LaFratta when it became public that LaFratta was convicted in 2000 of stealing $42,000 in donations from Tufts University School of Medicine. Rich admitted the decision to hire LaFratta was "very stupid." Benson is still working, even though it turned out he had pled guilty of tax evasion in 2001. Rich's comment was "why not give Arnie a second chance?"
    One former Hubbard nurse, who was born in the hospital, called the events "a slap in the face." A member of the Hubbard Regional Hospital Guild, an auxiliary fund-raising organization, was more graphic, "The hospital was gradually being raped by various entitities."
    Even small community hospitals in the US are not safe from leadership by the inept and the conflicted.
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