Showing posts with label ill-informed management. Show all posts
Showing posts with label ill-informed management. Show all posts

Monday, October 6, 2014

Can Our Dysfunctional Health Care System Contain Ebola?

Not to bury the lede, I think it can, but it will be a lot harder than the talking heads on television predict.

I have been writing about health care dysfunction since 2003.  Lots of US politicians would have us believe we have the best health care system in the world (e.g., House of Representatives Speaker John Boehner (R-Ohio), here),   Much of the commentary on Ebola also seems based on this "best health care system in the world" notion.  For example, in an interview today (5 October, 2014) on Meet the Press, Dan Pfieffer, "senior White House adviser," said

There is no country in the world better prepared than the United States to deal with this.  We have the best public health infrastructure and the best doctors in the world.

However, at least the statistics say compared to other developed countries, US processes and outcomes are at best mediocre using the best of some admittedly flawed metrics (look here), yet our costs are much higher than those of comparable countries.  Furthermore, on Health Care Renewal we have been connecting the dots among severe problems with cost, quality and access on one hand, and huge problems with concentration and abuse of power, enabled by leadership of health care organizations that is ill-informed, incompetent, unsympathetic or hostile to health care professionals' values, self-interested, conflicted, dishonest, or even corrupt and governance that fails to foster transparency, accountability, ethics and honesty.

Thus there is reason to worry that it will be harder than many expect for the US to deal with Ebola.  There is already some evidence that some of the sorts of problems we have been discussing for years made it harder for the US to cope with even the so far limited incursion of Ebola.

Financialization of Pharmaceutical and Biotechnology Companies

George W Merck famously said,
 
We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.

In the pharmaceutical industry, the era of George W Merck is over.  The failure to have access to an effective Ebola virus vaccine exemplifies how things have changed.

If we were to have an effective Ebola virus vaccine, we could have likely used it to vaccinate health care workers and contacts of infected patients and likely thus halt the epidemic early.


A story in Modern Healthcare suggested that now many of the big experts on Ebola and public health are concluding having a vaccine available would be very helpful,

 As West Africa's Ebola outbreak continues to rage, some experts are coming to the conclusion that it may take large amounts of vaccines and maybe even drugs — all still experimental and in short supply — to bring the outbreak under control.

Specifically,

'It is conceivable that this epidemic will not turn around even if we pour resources into it. It may just keep going and going and it might require a vaccine,' Dr. Anthony Fauci, director of the U.S. National Institute for Allergy and Infectious Diseases, told The Canadian Press in an interview.

The main reason we do not yet have such a vaccine does not appear to be scientific, but economic.

Here we posted discussion of arguments that pharmaceutical and biotechnology companies up to now have been uninterested in developing Ebola vaccines because they did not anticipate that such vaccines would produce a lot of revenue.  About one month ago, the Independent ran yet another story about an Ebola expert who believed this was the main reason for the lack of effective vaccine development up to now.

The scientist leading Britain's response to the Ebola pandemic has launched a devastating attack on 'Big Pharma', accusing drugs giants including GlaxoSmithKline (GSK), Sanofi, Merck and Pfizer of failing to manufacture a vaccine, not because it was impossible, but because there was 'no business case'.

West Africa's Ebola outbreak, which has now claimed well over 2,000 lives, could have been 'nipped in the bud', if a vaccine had been developed and stockpiled sooner – a feat that would likely have been 'do-able', said Professor Adrian Hill of Oxford University.


The US health care system is now heavily commercialized.  Health care corporations, including pharmaceutical and biotechnology companies, are often lead by generic managers who subscribe to the business school dogma of the "shareholder value theory," which seems to translate into putting short-term revenues ahead of all other goals.  Thus they have been "financialized."  At least in the pharmaceutical and biotechnology sector, such financialization appears to now be global. 

It may now be too late to contain this particular Ebola virus epidemic using a vaccine.  But unless we change how decisions are made about vaccine development, and end the dominance of financialization over drug and vaccine development, we may not be able to control the next deadly epidemic using vaccines either.

Generic Management Deluded by Business School Dogma

On 2 October, 2014, InformaticsMD posted on Health Care Renewal his speculation that the Ebola patient now hospitalized in Dallas was not identified on his first emergency department visit to Texas Health Presbyterian hospital even though a nurse apparently found out he had recently traveled from Liberia because of problems with how the hospital's electronic health record (EHR) transmitted or displayed this information.  This supposition was later apparently confirmed, but then the hospital system CEO retracted this explanation, leaving the reason he was sent home from the ED, thus risking infection of more contacts, unclear (see this post).

I now speculate that the larger reason for the problems the hospital had and is having both handling this patient, and explaining how it handled the patient is hospital leadership by generic managers who do not really understand the relevant health care issues.


Mr Barclay E Berden, the CEO of Texas Health Resources, has had a long career in hospital management.  However, his most advanced degree was "a master's degree in business administration with a specialization in hospital administration from the University of Chicago Graduate School of Business."   His official biography suggests that he has no direct experience or training in medicine, health care, or biological sciences.  Nonetheless, when he became CEO this year, according to Modern HealthCare, the chairperson of the hospital system board thought he was fully qualified,

'He brings a well-rounded perspective and unique leadership strengths to the CEO position,' board Chair Anne Bass said in a news release. 'At the same time, he represents stability and continuity that will be critical to advancing our strategy as we confront the challenges of a rapidly changing healthcare environment.'

Nonetheless, the hospital systems seems to have had trouble confronting the challenges of the change in environment due to Ebola.  Also, according to a very recent story in the Dallas Morning News, there have been performance issues at Texas Health Resource hospitals, and specifically at Texas Health Presbyterian,

Texas Health Presbyterian Hospital — under fire for releasing a Liberian man who later turned out to have the Ebola virus — has lagged behind its peers on emergency room care and lost some federal funds the past three years because it had high discharge rates of patients who later had to return for treatment.

The hospital scored significantly worse than the state and national averages in five of six emergency care indicators, with emergency room wait times twice as long as the averages, according to data from the U.S. Centers for Medicare & Medicaid Services.

The hospital also was the most penalized in Dallas under a three-year program designed to reduce the number of patients readmitted for care, according to the data.

The delays in patient treatment in the emergency room, in particular, raise important questions about Presbyterian’s emergency care, said Dr. Ashish Jha, a professor at Harvard University’s School of Public Health and a practicing general internist.

In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). As we noted here, the growth continued, so there are now 10 managers for every US physician. 

We have frequently discussed how generic managers in charge of health care organizations may follow business-school dogma at the expense of patients' and the public's health.  In particular, they may also prioritize short-term revenue ahead of all other concerns, and hence may favor high-technology and procedural care, often performed electively, ahead of the the less glamorous and remunerative parts of health care, e.g., ED care of poor, uninsured, febrile patients.

Unfortunately, much of the country's efforts to ward off Ebola are likely to be lead by generic managers who may have little understanding of epidemiology, public health or virology, and little understanding of the state of health care at the sharp end.  So unfortunately I expect continuing "glitches," or worse.  Hopefully, the country, although not every single one of its inhabitants, will survive them.  Then we need to seriously reflect on the wisdom of handing control of health care over to generic managers, rather than health care professionals. 


Commercialization of Health Care Leading to Neglect of Routine Acute Care and Public Health 

Just as national politicians and government leaders have repeated the meme of the US health care system being "the best in the world," now that Ebola has come to Texas, state leaders have sung the same song.  For example, an editorial in the Baltimore Sun quoted the state health commissioner,

'This is not West Africa,' Texas health commissioner Dr. David Lakey said Wednesday at a news conference designed to dispel Texans' (and Americans') fear of an Ebola outbreak after a man there was diagnosed with the disease. 'This is a very sophisticated city, a very sophisticated hospital.'

The Texas Tribune ran a story produced in cooperation with Kaiser Health saying,

At a Wednesday press conference to discuss the Ebola case, Gov. Rick Perry said he was confident in the state’s preparedness. 'There are few places in the world better equipped to meet the challenge that is posed in this case,' he said. 'We have the health care professionals and the institutions that are second to none.'

However, another Dallas Morning News story recounted various problems in the public health response to the Dallas Ebola patient, including,

Delay in blood testing
After Duncan was admitted to the hospital, health officials waited nearly two days to test his blood for the Ebola virus. This may have delayed containment of people who had contact with him.
Slow containment and cleanup
Health officials left some of Duncan’s close contacts in the apartment where soiled linens and towels that he had used remained.
Failure to avoid contact with emergency workers
Ambulance workers and sheriff’s deputies are among those being monitored.

So, there is reason to suspect that the public health system in Texas may not exactly be the best in the world.  In fact, there seem to be systemic problems with public health in Texas that the Ebola scare is bringing to increased public notice.  The Texas Tribune/ Kaiser story went on to explain that in Texas, a state in which distrust of central government is great, and confidence in the private sector is high, public health is both decentralized and often poorly funded,

'We don’t really have a unifying construct for public health in Texas that’s comprehensive,' said Dr. Eduardo Sanchez, the former commissioner of the Texas Department of State Health Services (DSHS) and current chairman of the Texas Public Health Coalition. 'The system is not as connected as it could be.'

Furthermore,

But public health experts argue that the state’s response system is 'fragmented' and vulnerable to local budget cuts, which they say could hamper crisis-response efforts in the case of diseases that are more easily transmitted.

Texas’ local health departments, which provide services like immunizations and disaster response planning, operate autonomously and are funded primarily by local taxes but may be supplemented by state and federal grants. Because local health departments are not held to a single standard, their services and budgets vary tremendously around the state.

A report critical of the state’s public health system, prepared by the Sunset Advisory Commission, found that 'the roles and responsibilities of DSHS and local health departments remain undefined.' The Sunset Commission is tasked with highlighting inefficiencies at state agencies and recommending legislative action.

'A ‘local health department’ can be a few staff conducting restaurant inspections and animal control duties, or a large agency directing sophisticated disease surveillance, operating a public health laboratory and providing direct services to citizens,' according to the report.>

Some public health officials have criticized the state’s model as disjointed. Many local health departments operate independently; however, if local budget cuts to a public health department force it to discontinue a health service, DSHS is often required to step in and take responsibility for that service. The state is then left to foot the bill.

'In the event of a public health emergency ... the resources necessary to adequately respond to that are not all in the control of the health department,' Sanchez said. 'You have to have the money and the authority — whether it’s informal or formal — to actually lead a response and take care of business.'

Local entities have slashed funding for health departments in recent years, said Catherine Troisi, an epidemiologist at the University of Texas School of Public Health in Houston. Thirty-six percent of local health departments in Texas laid off staff as a result of budget cuts between 2008 and 2013, according to the National Association of County and City Health Officials.

'Public health is politics,' Troisi said.

In the US, we have pushed commercialization of health, health care and public health.  Much of our health insurance is provided by for-profit corporations.  Some of our hospitals and other organizations that provide direct patient care are for-profit.  As we noted above, most of our health care organizations are now run in a "business-like" manner by managers trained in business, but not necessarily in health care or biological science.  The thus revenue-focused health care system has emphasized procedures and high-technology, often at the expense of the basics.  So it should not be s surprise that Reuters just reported,

 Nurses, the frontline care providers in U.S. hospitals, say they are untrained and unprepared to handle patients arriving in their hospital emergency departments infected with Ebola.

Many say they have gone to hospital managers, seeking training on how to best care for patients and protect themselves and their families from contracting the deadly disease, which has so far killed at least 3,338 people in the deadliest outbreak on record.


Furthermore, using as an example Medstar Washington Hospital Center, the largest hospital in Washington, DC,

Nurses argue that inadequate preparation could increase the chances of spreading Ebola if hospital staff fail to recognize a patient coming through their doors, or if personnel are not informed about how to properly protect themselves.

At Medstar, the issue of Ebola training came up at the bargaining table during contract negotiations.

'A lot of staff feel they aren't adequately trained,' said [Emergency Department nurse Micker] Samios, whose job is to greet patients in the emergency department and do an initial assessment of their condition.

So Young Pak, a spokeswoman for the hospital, said it has been rolling out training since July 'in the Emergency Department and elsewhere, and communicating regularly with physicians, nurses and others throughout the hospital.'

Samios said she and other members of the emergency department staff were trained just last week on procedures to care for and recognize an Ebola patient, but not everyone was present for the training, and none of the other nursing or support staff were trained.

'When an Ebola patient is admitted or goes to the intensive care unit, those nurses, those tech service associates are not trained,' she said. 'The X-ray tech who comes into the room to do the portable chest X-ray is not trained. The transporter who pushes the stretcher is not trained.'

If an Ebola patient becomes sick while being transported, 'How do you clean the elevator?'

Nurses at hospitals across the country are asking similar questions.

A survey by National Nurses United of some 400 nurses in more than 200 hospitals in 25 states found that more than half (60 percent) said their hospital is not prepared to handle patients with Ebola, and more than 80 percent said their hospital has not communicated to them any policy regarding potential admission of patients infected by Ebola.

Another 30 percent said their hospital has insufficient supplies of eye protection and fluid-resistant gowns.

So up to now, it appears that in the state of Texas, and across the country, the preparedness of public health systems and of front-line hospitals to deal with Ebola is unclear.  This may be due to political cuts in funding of public agencies, a payment system that favors procedures and high-technology over basic care, and leadership by generic managers who prioritize making money short-term over less financially advantageous priorities like preparedness for epidemics.  

Summary
Thus again there is reason to fear that our commercialized health care system run by generic managers, and our neglected public health system scorned because it is not "business-like" may not be fully up to the task of containing Ebola.  Again, hopefully this too will pass, without too many casualties.  However, one, maybe the only silver lining in the dark clouds of the Ebola crisis seem to be its capacity to challenge the pompous certainty by those invested in the status quo that we have the best health care system in the world.

The Ebola crisis should, again, lead to serious reflection on true health care reform, reform that would address concentration and abuse of power, reform that would enable leadership of health care by  well-informed people who are devoted to patients' and the public's health, who are honest and ethical, who are willing to be held accountable, and would shrink the size and power of individual health care organizations to make them truly responsive to patients' health care needs and the public's health needs. 

ADDENDUM (10 October, 2014) - This post was re-posted on the Naked Capitalism blog, and on OpEdNews.com

Thursday, June 5, 2014

Grand Jury: Ventura County, Calif., Mishandled Electronic Health Records Transition

In Ventura County, California, "the function of the Grand Jury is to act as a civil oversight of county and city government, special districts, governing boards, personnel commissions, school districts, and humane officers. It is their responsibility to insure that government is serving the best interests of Ventura County's citizens" (http://www.ventura.org/grand-jury).

Even under such a grand jury, the need for true Health IT experts (instead of amateurs) seems to have gone unnoticed.

A 2013-2014 Ventura County Grand Jury conducted an investigation in response to information received regarding the implementation of a new Electronic Health Records system by the Ventura County Health Care Agency (VCHCA).


Ventura County Grand Jury Final Report "Healthcare Records Processes and Procedures" (full PDF at http://vcportal.ventura.org/GDJ/docs/reports/2013-14/Healthcare_Records-05.29.14.pdf)


From the May 29, 2014 Ventura County Grand Jury Final Report "Healthcare Records Processes and Procedures" (full PDF at http://vcportal.ventura.org/GDJ/docs/reports/2013-14/Healthcare_Records-05.29.14.pdf).  Read the full report.  Any reader of this blog or my Drexel HIT site at http://cci.drexel.edu/faculty/ssilverstein/cases/ will recognize very familiar patterns.

Here are some highlights:

In April 2012, VCHCA hired an independent Information Technology (IT) consultant to oversee the EHR implementation; however, he was not authorized to be project manager.

An "independent IT consultant" who had no formal Medical Informatics expertise is a likely explanation for all that followed.  (Even if he did, his relegation to "internal consultant" was an attempt to seduce failure into rearing her ugly head.)

The Grand Jury found that, beginning with the authorization of the Cerner contract in October 2011, there was a lack of a dedicated and experienced project manager to oversee, track, and report all tasks related to the EHR implementation. The absence of a recognized standard project plan, as shown in the Project Management Institute’s A Guide to the Project Management Body of Knowledge (PMBOK® Guide), contributed to staff being inadequately prepared for using the new system and to a problematic EHR system implementation by VCHCA.

Lack of a "recognized standard project plan" was likely the least of the problems.

The Grand Jury found hiring of “contract staff” did not support project needs. The Ventura County Board of Supervisors’ (BOS) approval of additional funds allowed for the hiring of deployment staff. Hiring did not commence until August 2012, and continued after the VCHCA system “go-live” date of July 1, 2013. This indicated a lack of planning and diligence in pursuing the necessary qualified staff.

Lack of enough "contract IT staff" was likely the least of the problems.

The Grand Jury found that staff training on the new equipment was insufficient, leading to a lack of experience and knowledge with all components of the EHR system. There was a period of inefficient and delayed patient care.

Billing processes were significantly impacted, requiring manual intervention, taking additional time.

These are symptoms of what was likely truly lacking.

The Grand Jury found that VCHCA ordered the user hardware in May and June 2013, too late to allow proper time for configuring of computers, hardware testing, and user familiarization.
 
The Grand Jury found that VCHCA had until the end of December 2014 to implement the new EHR system to avoid federal penalties.

The Grand Jury found that VCHCA had to be on the EHR system for 90 days prior to September 30, 2013, to qualify for full Meaningful Use funding, therefore July 1, 2013 was selected as its go-live date.

It was all about money.  Still, that was not the likely problem.

The problem was likely leadership by healthcare IT amateurs**, lacking formal cross-disciplinary expertise in medicine and clinical computing.

Without that expertise, empowered in top leadership roles, these projects will fail or will be seriously impaired, at great cost.

If you don't believe me, believe the NIH (http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html).

While the 'Grand Jury' investigation of a failed health IT project may be a first, and is not a bad development in my mind, perhaps the members of the Grand Jury need to read a bit more.

-- SS

** I am a radio amateur, a formal FCC designation for those licensed to use radio and who have some knowledge, but who are not formal radio telecommunications engineers (unless they have the required formal education, training and experience, of course).

Monday, May 26, 2014

Athens Regional Medical Center: Hospital management is "addressing computer problems" AFTER patients are put at bodily risk, not before, only in response to irate clinicians; then claiming everything will be fixed soon while doctors resign.


Maybe hospital management gurus could address these computer problems BEFORE turning them loose on patients?

Physicians in Georgia seem to have more guts than their colleagues elsewhere.  Rather than letting patients be guinea pigs for the naive fantasies of hospital executives about health IT, these physicians said "get these [expletive] computer systems out of our hospital"...

Then they started resigning their appointments:

Athens Regional addressing new computer system problems encountered by doctors

By Donnie Z. Fetter
Friday, May 23, 2014

http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors

Doctors affiliated with Athens Regional Medical Center (http://www.athenshealth.org/) have expressed concerns that a computer system installed this month at the hospital endangers patients.

Not "may endanger patients."  "Endangers patients."  That's quite direct.

However, the hospital's chief executive said Athens Regional is taking "swift action" to address those concerns.

I'm not impressed.  The executives should perhaps have done due diligence and taken action BEFORE this bad health IT was set loose on live, unsuspecting patients.

It's not as if the issues are unknown (as Google or anyone who actually knows what they're doing regarding health IT will easily demonstrate).  Further, those executives have the legal obligation to maintain a safe healthcare environment.

In a letter dated May 15 and provided to the Athens Banner-Herald this week, multiple doctors noted such concerns as “medication errors ... orders being lost or overlooked ... (emergency department) patients leaving after long waits; and of an inpatient who wasn’t seen by a physician for (five) days.”

Any of these issues and the multitude more I can predict exist can lead to severe injury or death, especially in fragile patients and the elderly.  Trust me, I know both professionally and personally...
 
The letter was addressed to ARMC President and CEO James G. Thaw and Senior Vice President and CIO Gretchen Tegethoff. It was signed by more than a dozen physicians, including Carolann Eisenhart, president of the medical staff; Joseph T. Johnson, vice president of the medical staff; David M. Sailers, surgery department chair; and, Robert D. Sinyard, medicine department chair.

The doctor who provided the letter to the Banner-Herald refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues.

Refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues ... due to fear the executives would then return the doctor's concerns with genuine love and appreciation, and give him or her a generous promotion and pat on the back, no doubt.  (Actually, quite likely was a fear of retaliation, e.g. sham peer review as at http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians.)

Note the educational background of CIO Gretchen Tegerhoff, the executive with fiduciary obligations to implement health IT of the highest quality and to have robustly researched all of the issues involved (and whom the Board should have thoroughly vetted as to required background for health IT leadership):

University of Georgia
Terry College of Business, Executive Program, Finance
2014 – 2014 (expected)

The George Washington University - School of Business
Master of Science, Information Systems Technology
2001 – 2003

West Virginia University
BS, Medical Technology
1993 – 1997

Note the career progression that is the envy of, say, someone who's completed the rigors of medical training (premed, medical school, internship/residency, clinical postdocs) and beyond that, completed an additional PhD, MS or post-doctoral fellowship in Medical Informatics at unknown universities such as Harvard, Yale, Stanford, Johns Hopkins, Columbia, etc. (reverse chrono):

Technical Analyst
STG (9 months)
[Provided U.S. Department of State with systems support and application maintenance.]

Clinical Systems Analyst
George Washington University Hospital (3 years 8 months)

Technical Support Specialist/Installer
Intellidata, Inc. (9 months)

Clinical Research Associate
QUINTILES, INC. (9 months)

Information Specialist
THE EMMES CORPORATION (1 year 8 months)

Writer/Editor
ASPEN SYSTEMS CORPORATION (7 months)

Medical Technologist
PROVIDENCE LABORATORY ASSOCIATES (8 months)

This background led directly to:

Chief Information Officer
George Washington University Hospital (6 years 8 months)

and then the current role:

Athens Regional Health System
Vice President and Chief Information Officer
Athens Regional Health System

If you believed that the qualifications required for medical practice - let alone medical leadership roles - is at least an order of magnitude more robust, you'd not be mistaken.

Perhaps even worse, business-IT amateur meddlers in clinical affairs sell the "best practices" that lead to debacles like this, and perhaps to IT-related patient injury and death, via their alphabet-soup "leadership" organizations.  This CIO also holds this credential:


Faculty
CHIME Healthcare CIO Boot Camp (8 months)

It should be noted, and scandalously so considering the negligence that leads to patient endangerment and this kind of physician revolt from the outset, that IT-related patient harms are not uncommon.  For example, per the Harvard community's med mal insurer CRICO, see "Malpractice Claims Analysis Confirms Risks in EHRs" at
http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html, the ECRI Institute, see "ECRI Deep Dive Study of Health IT harms" at
http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html as well as "ECRI Institute's 2014 Top 10 Patient Safety Concerns for Healthcare Organizations" at
http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html, "FDA Internal Memo on H-IT risks - for internal use only" (uncovered by investigative reporter Fred Schulte) at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html, and others as posted at this blog.

“From the moment our physician leadership expressed concern about the Cerner I.T. conversion process on May 15, we took swift action and significant progress has been made toward resolving the issues raised,” Thaw wrote Thursday in an email. “Providing outstanding patient care is first and foremost in our minds at Athens Regional, and we have dedicated staff throughout the hospital to make sure the system is functioning as smoothly as possible through this transition."

This raises several questions:

  • How about the moments from the time of decision to acquire the technology?  What safety consideration were in effect during that time? 

  • What if the "significant progress" is insufficient to prevent a patient from being maimed or killed due to toxic effects of bad health IT?  Who's responsible? 

  • Perhaps most importantly from the human rights perspective - are patients being provided informed consent about these "issues raised" and are they afforded the opportunity to seek care elsewhere until the "swift progress" is completed?  

One wonders if the executives were aware of analytic work on Cerner ED systems such as performed by U. Sydney professor Jon Patrick at "A study of an Enterprise Health information System",  http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146; or this site on health IT difficulties:  http://cci.drexel.edu/faculty/ssilverstein/cases/, or this blog and others.

It's not as if a simple Google search won't find them, such as https://www.google.com/search?q=healthcare+IT+failure.  Perhaps they need to read more...or hire experts BEFORE go-live.

Back to the article:

The intended goal of the system designed by health care information technology company Cerner is to improve efficiency and connectivity by providing doctors, nurses and other medical professionals with a shared data set and to eventually allow patients online access to their medical records, Athens Regional executives previously said.

Good intentions or not, badly designed and/or implemented technology harms or kills, and those harmed, or the dead, really don't care what the system is 'intended to do.'  Patients are not guinea pigs towards an IT company's or hospital's experiments with computers - regarding which the executives are usually in to at a level way over their collective heads.

But doctors noted the new system often proved too cumbersome to be effective at the time the letter was written.

“The Cerner implementation has driven some physicians to drop their active staff privileges at ARMC,” noted the letter. “This has placed an additional burden on the hospitalists, who are already overwhelmed.

That's just horrendous for safety.

Joint Commission, where are you?
 
Other physicians are directing their patients to St. Mary’s (hospital) for outpatient studies, (emergency room) care, admissions and surgical procedures. ... Efforts to rebuild the relationships with patients and physicians (needs) to begin immediately.”

Doctors voted with their feet.  Bravo.

I suggest they consider the following remedies as well if appropriate, from my post at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html:

... When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)


  • Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "disruptive physician" and/or or being subjected to sham peer review (link).
  • Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)
  • Inform the State Medical Society and local Medical Society of your locale.
  • Inform the appropriate Board of Health for your locale.
  • If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "Quality Insights of PA."
  • Inform a personal attorney.
  • Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.
  • As clinicians are often forced to use health IT, at their own risk even when "certified" (link), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:
"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]

We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice.

With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at http://www.jointcommission.org/assets/1/18/SEA_42.PDF, the IOM report on HIT safety at http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, and the FDA Internal Memorandum on H-IT Safety Issues at http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology.

CMO __________ (date, time)
CIO ___________ (date, time)
CMIO _________ (date, time)
General Counsel ___________ (date, time)
etc."
  • If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.
  • As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.

These measures can help "light a fire" under the decision makers, and "get the lead out" of efforts to improve this technology to the point where it is usable, efficacious and safe.

More from the article:

Doctors called the time line to install the EHR system too “aggressive” and said there was a “lack of readiness” among the intended users.

For financial incentive reasons in part, I'm sure.  Computers, after all, seem to have more rights than patients...or than physicians and nurses.

Since receiving the letter, Thaw said Athens Regional has added "specialized staff" to meet daily with physicians to discuss computer system and safety issues.

Again, the key word is "AFTER."   A good move, considering the hospital will be up to its head in defections, accreditation inspections and hearings, and possible medical malpractice and corporate liability lawsuits otherwise.

"Regardless of what system we are using, our focus on patient safety is unwavering, and we will never put a system ahead of doing what is right for our patients," Thaw said. "Our team is working around the clock to resolve any remaining issues, and we remain dedicated to delivering outstanding patient care every step of the way."

Feel-good executive boilerplate and an outright lie on its face.  If the focus on safety was unwavering, this problems would not now need emergency remediation.  As I had written many years ago here: http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story, this type of shallow executive puffery and rhetoric only makes clinicians angrier.

And while events like this go on, the industry pundits suggest all that's needed is a Health IT 'Safety Center' instead of regulation like the rest of the healthcare industry ("Feds Call For Health IT Safety Center", May 20, 2014, http://www.govhealthit.com/news/feds-call-hit-safety-center?topic=,26#.U4FVDnYsC).  This is sort of like putting the safety of our country's hospitals in the hands of Consumer Reports.

That's not exactly the ticket to a rapid cure to these problems, which are more common than most physicians have the bravery (or career options in the face of retaliation) to admit.

At least nurses' unions are taking action, as at http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html and http://hcrenewal.blogspot.com/2014/05/a-nurses-union-national-nurses-united.html.

Additional thought:  at least the writer of the article did not use the customary euphemism for problems with patient-endangering bad health IT, specifically: "glitches" (http://hcrenewal.blogspot.com/search/label/glitch).

-- SS

May 27, 2014 Addendum:

The CEO has apparently resigned, see http://onlineathens.com/local-news/2014-05-23/thaw-resigns-athens-regional-ceo

I also solicit physicians from the area of this hospital to contact me regarding any patient harms that did occur as a result of this debacle, via my email address located here: https://www.blogger.com/profile/03994321680366572701.  I will forward any reports through appropriate legal channels to attorneys who can take action, which in 2014 is probably the only language this industry will actually listen to.

-- SS

May 27, 2014 Addendum 2:

The reader comments at http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors are interesting, and distressing.

-- SS

May 29, 2014 Addendum:

More here:  http://flagpole.com/news/in-the-loop/james-thaw-out-as-armc-ceo

If I were that's hospital's new leadership, I'd immediately go back to whatever system (whether paper or not) was in place before this implementation, and take the time to implement new health IT properly, safely and carefully.

For at this point, if patient injury or death occurs as a result of a system flaw (whether in design or implementation), I believe charges of criminal negligence against the organization and its leaders would be justified.

The following is an example of one state's statute defining criminal negligence:

''A person acts with 'criminal negligence' with respect to a result or to a circumstance described by a statute defining an offense when he fails to perceive a substantial and unjustifiable risk that such result will occur or that such circumstance exists. The risk must be of such nature and degree that the failure to perceive it constitutes a gross deviation from the standard of care that a reasonable person would observe in the situation.''

I believe other states' statutes are similar.

-- SS

June 13, 2013 Addendum:

My post on Athens Regional Medical Center's physician revolt was accessed today by someone at Cerner; note the referring link:  http://cerner.vertabase.com/project/document/index.cfm?&0.12455576848

Vertabase (http://www.vertabase.com/) makes project management software.

Cerner.vertabase.com/project/document is some sort of password-protected document resource.

I find that interesting - perhaps it's for internal communications and they are learning something from me.



Domain Name (Unknown) 
IP Address159.140.254.# (Cerner Corporation)
ISPCerner Corporation
Location
Continent : North America
Country : United States  (Facts)
State : Kansas
City : Kansas City
Lat/Long : 39.1111, -94.6904 (Map)
LanguageEnglish (U.S.)
en-us
Operating SystemMacintosh MacOSX
BrowserSafari 1.3
Mozilla/5.0 (Macintosh; Intel Mac OS X 10_8_5) AppleWebKit/536.30.1 (KHTML, like Gecko) Version/6.0.5 Safari/536.30.1
Javascriptversion 1.5
Monitor
Resolution : 1440 x 900
Color Depth : 24 bits
Time of VisitJun 13 2014 11:47:42 am
Last Page ViewJun 13 2014 11:47:42 am
Visit Length0 seconds
Page Views1
Referring URL
http://cerner.vertabase.com/project/document/index.cfm?&0.12455576848
Visit Entry Pagehttp://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html
Visit Exit Pagehttp://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html
Out Click
Time ZoneUTC-6:00
Visitor's TimeJun 13 2014 10:47:42 am
Visit Number1,342,222

 -- SS

Note: also see my June 16, 2014 followup post at http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html

Wednesday, June 19, 2013

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

At my May 30, 2013 post "Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients ... CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue" at http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html, I lamented that hospital management felt they could ignore clinicians calling for implementation postponement of what they viewed as bad health IT, dangerous to patients, with impunity.

Finally, medical professionals stand up to imperial hospital management that, in a perhaps criminally negligent fashion (e.g., see my post on the ECRI Deep Dive Study on Health IT harm at this link), ignores its clinicians over too-rapid deployment of health IT.

Also see newspaper article at http://www.cantonrep.com/news/x393137745/Affinity-nurses-seek-delay-on-electronic-records#axzz2WcOMZpvF.

(The hospital management is extolling the safety of the new Cerner system.  What could possibly go wrong?  -- I'd bet the executives, despite their fiduciary duties towards maintaining a safe hospital environment, have no idea about Cerner defects such as at the FDA MAUDE database; see "MAUDE and HIT Risks: What in God's Name is Going on Here?" at http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html or are familiar with "Medical center has more than 6000 'issues' with Cerner CPOE system in four months" at http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html.  Instead, unpaid bloggers do their work for them to protect patients....)

See this:

-----------------------------
For Immediate Release - June 18, 2013
For more information: Michelle Mahon, RN, 234-207-6706 or Liz Jacobs, RN, 510-273-2232

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday


Affinity Medical Center RNs in Massillon, Ohio are calling on hospital officials to delay the planned June 21 implementation of the Cerner electronic medical records (EMR) system, until the hospital bargains with the nurses and proceeds in a safe manner.

The direct-care RNs, represented by the National Nurses Organizing Committee (NNOC) in Ohio, an affiliate of National Nurses United (NNU), say that nurses, the primary users of the complex system, have had insufficient training, which will put patients at risk. The implementation, which has been done without bargaining with NNOC, reflects yet another violation of federal labor law by Affinity, nurses say.

Nurses have documented their concerns in a detailed letter to hospital officials. Those concerns include woefully inadequate training, short staffing in the first days of the roll out, and the subsequent risk of harm to their patients.  The system, they say, has the potential of violating the Ohio Nursing Practice Act because it doesn’t permit RNs to communicate individualized, potentially life-saving information about their patients.
The letter, which RNs attempted to deliver to hospital officials on Friday, cites nationally recognized experts in health information technology who reinforce the RNs’ concerns. Most notably, the Institute of Medicine (IOM) has concluded that the failure to include RNs in all steps of this transition is one of the most significant barriers to successful, safe implementation of electronic health records systems.

Hospital officials have continued to refuse to meet with nurses, and would not accept the letter.  [Willful ignorance? - ed.] Without bargaining with the union or acknowledging the nurses’ concerns, the hospital added a few more trainings late Friday, but the RNs say that remains far from adequate.

Over the last few years, American healthcare corporations have invested heavily in information technology (IT) systems, which make up a multi-billion dollar market.

“RNs who actually use these systems day in and day out have found that the kind of care they can provide with this new technology is limited,” said NNOC Co-president Cokie Giles, RN. “The programs are often counterintuitive, cumbersome to use, and sometimes simply malfunction. Nurses are finding that the technology is taking time away from patients and fundamentally changing the nature of nursing.”

NNOC/NNU has successfully negotiated clauses in its contracts that allow RNs to play a greater role in reviewing and approving new technologies before they are introduced, and that the new technologies will not supersede RN professional judgment. 

“I have been chosen as a ‘super-user,’ said Amy Pulley, an RN who works in the endoscopy unit of the hospital. “I’m not sure what makes me ‘super’ with the limited training for this complex system that I’ve received. I’m concerned that the manner in which this technology is being implemented may pose serious disruptions in patient care.”

Highlights of RN Concerns on the Implementation of the Cerner Electronic Medical Records System at Affinity Medical Center

Inadequate Staffing
·        Several units will be severely short staffed for the transition, despite the fact that the hospital has been planning on the “go live” date for several months.
·        The entire hospital and all portions of the system will go live at once, referred to as the “big bang” approach, which has a very low rate of success, rather than implementing it in trial, pilot stages.
·        They are utilizing the ‘super-user’ model which will pull nurses from direct-care so they can be available to teach, leaving several units without enough nurses to care for patients.
·        The hospital refuses to decrease the number of elective procedures or provide additional staff during the transition time.

Lack of training
·        Some nurses have received only one day of training.
·        Super-users have received no education or training in the system beyond what is provided to the other users.

Design flaws
·        Placement of the workstations are ill conceived—RNs must turn their back to patients while documenting.
·        During one education session, the system crashed because 17 users at one time overloaded it.

Failure to consult nurses
·        Several concerns were brought to management’s attention which they were unable to answer. One example— how will RNs override the system in the event of an emergency?

Affinity is one of five hospitals in California, Ohio, and West Virginia that are part of one of the nation’s largest for-profit hospital chains, Tennessee-based Community Health Systems where affiliates of NNU are pursuing federal action for significant violations of RN rights.

The National Labor Relations Board held a five-day hearing in May in a complaint filed by the nurses and NNOC over Affinity’s refusal to bargain a first contract and retaliation against RNs for advocating for their patients and their colleagues. A decision by an NLRB administrative law judge is pending. CHS affiliated hospitals in West Virginia and California are facing similar sanction from federal officials. At one of the California hospitals last week, a U.S. District Court judge issued an injunction ordering the hospital to return to negotiations with the RNs.
CHS is the second largest for-profit hospital chain in the United States, and one of the wealthiest. Over the past five years, CHS reported over $1.5 billion in profits to the Securies Exchange Commission.


Michelle Mahon, RN
National Representative
National Nurses United
mmahon@nationalnursesunited.org
234-207-6706

I believe the nurses should strike if their concerns are not heeded.

I once worked in a highly-unionized city Transit Authority; I believe the unions would have shut the Authority down in the face of even a fraction of concerns like this that could impact pubic safety - and their own memberships' careers and lives.

-- SS

6/20/13 addendum:

I note that this EHR medical device (per FDA) is non-FDA approved, nor vetted by any regulatory agency.  Apparently the hospital believes it has the prerequisite skills and expertise to vet this device for safety.  Who, exactly, will take responsibility for bad outcomes?

FDA's Chair of the Center for Device and Radiological Health, Jeffrey Shuren, MD JD, stated explicitly that EHRs were medical devices on Feb. 25, 2010 (see testimony to the HHS Health Information Technology HIT Policy Committee at this PDF) that:

... Under the Federal, Food, Drug, and Cosmetic Act, [that regulates all drug, medical devices, etc. in the United States - ed.] HIT software is a medical device. Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems)... To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices.


I also note that patient informed consent to its use in their care is likely not being sought.  Should it?  If not, why not?

-- SS

9/2/2013 addendum

The comment by "Anonymous August 20, 2013 at 11:24:00" has many characteristics of a sockpuppet (see http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html) - ignoring everything written in the post and expressing perverse and deranged views.  See it, and my response, in the comment section.  A post about an anti-health IT union dispute such as this is a strong potential sockpuppet magnet.

-- SS

Wednesday, May 8, 2013

Tales of the Wayfaring Generic Manager - from Ritz Carlton Hotels to Henry Ford West Bloomfield Hospital to Cancer Treatment Centers of America

In 2006, we wondered what a former hotel manager, Mr Gerard van Grinsven, admittedly known for putting the "wow" back in the Detroit Ritz-Carlton, would be doing as a hospital CEO.  This seemed at the time like a real "wow" example of how generic managers were taking over health care.  Mr Grinsven had extensive experience in the hospitality field, but no known background in health care. 

Organic Local Produce, "Wellbeing Centers," Gourmet Dining, Wedding Receptions, and Corporate Functions

Over the next few years, Mr van Grinsven's Henry Ford West Bloomfield hospital did make a name for itself.  In 2009, Becker's Hospital Review reported on some of Mr Van Grinsven's innovations. 

First, he lead an apparent change in the hospital's mission from acute care to recreating:

the hospital experience into one focused on promoting wellbeing and healthy living. The hospital has already begun to realize its mission statement, which reads 'to take health and healing beyond the boundaries of imagination.'

The new hospital apparently was designed to look like a luxury hotel:

The hospital is located on 160 acres of woodlands and is designed to resemble a Northern Michigan lodge. The facility also features a retail 'main street' which looks like an actual main street in a Northern Michigan town and includes stores focused on sleep, pregnancy, organic food and healthy cooking as well as a pharmacy.

Apparently it is now a favored site for weddings:

The hospital also holds free concerts for the community and has already received nine wedding inquiries. 

It had a "wellness center"

Henry Ford West Bloomfield also features a unique, integrated wellness center called Vita. Vita offers acupuncture, therapeutic message, yoga and relaxation classes, an aqua therapy suite, a spa and health coaches who provide lifestyle and exercise consultations. In addition to offering one-time services, the hospital offers memberships to community members to encourage frequent use of the center.

What really stood out was its food service:

Henry Ford brought in top Michigan chef Matt Prentice to transform traditional hospital food service. The hospital features 24-hour room service for patients, all of which is served by the hospital's on-site gourmet, organic restaurant, Henry's. All food served in the hospital is organic, promotes sustainable agriculture and, in many cases, is procured from local farmers.

A 2011 article in Fortune noted that

the hospital is on track to generate millions of dollars a year hosting and catering functions for companies and community groups.

It all sounds great, if it were describing a luxury hotel.

The Fortune article ended with the gushing summation:

While it will be years before anyone can say whether this model works, there's no question that it captures a spirit of innovation that just might be a cure for what ails so many organizations. We are living today through the age of disruption. You can't do big things if you're content with just doing things a little better than everyone else or a little differently from how you've done them in the past. In an era of intense competition and non-stop reinvention, the only way to stand out from the crowd is to stand for something special. Originality has become the acid test of strategy.

Neither it nor the Becker's rather uncritical discussions dealt with what any of this had to do with the fundamental mission of a hospital, to care for the sick, what it has to particularly do with quality of care, especially care of severely acutely or chronically ill patients, traditionally those whom hospitals were meant to serve.  Would a patient desperately sick from a myocardial infarction (heart attack), stroke, sepsis (bacterial blood stream infection) or the other major ills that bring people to hospitals really care that if he or she were to survive without major sequelae, organic, locally grown food would be served in the hospital's fancy restaurant?  Is there any evidence that provision of any of these fancy hotel amenities would affect important clinical outcomes for such patients?  Could the funds needed for all these fancy hotel services be better spent to improve patients' the the population's health?

On to a More Ethically Challenged Environment

We may never know.  But what we do know is that Mr van Grinsven, having brought "wellness" centers and organic, locally grown, gourmet food to an acute care hospital, is now moving on.

Crain's Detroit Business just reported:


Henry Ford West Bloomfield Hospital President and CEO Gerard van Grinsven has resigned from the position effective June 1, according to an internal email sent Friday to employees from Henry Ford Health System President and COO Bob Riney.

Van Grinsven is leaving the hospital to become the president and CEO of Chicago-based Cancer Treatment Centers of America, Riney said in the email. He will oversee the CTCA's five hospitals and medical centers in Illinois, Pennsylvania, Oklahoma, Arizona and Georgia. The CTCA is expected to announce van Grinsven's new position later today.

Henry Ford Health System CEO Bob Riney saluted van Grinsven thus,

'Gerard's leadership talents and his tremendous global experience made the transformation of this innovation and distinctive vision a reality,' Riney told employees in the email.

He did not apparently mention anything about the quality of care for acutely and chronically ill patients.  The press release from CTCA proclaimed

'Gerard's arrival is an exciting and dramatic step in the evolution of our leadership that will herald new opportunities for all of our talented Stakeholders and the thousands of patients we serve,' said [executive chairman and former CEO Stephen B] Bonner. 'Our expertise in Patient Empowerment Medicine® and track record implementing change is unparalleled. Nothing we do today is the same as we did two years ago. Gerard is uniquely qualified to provide the leadership required to advance our commitment to patient-centered care in all we do,' concluded Bonner.

Of course, there was nothing about how van Grinsven's expertise in wellness centers and organic produce would be useful to an organization supposedly devoted to cancer patients, whose care may involve risky treatment choices and who may become desperately ill.

There was also nothing about how van Grinsven's background would help CTCA to avoid new ethical misadventures.  Earlier this year, we posted about issues involving CTCA making unsubstantiated survival claims; promoting "integrative" treatments that are unsupported by evidence; and manipulating survival statistics, in part by turning away patients with poor prognoses.  Of course, it is not clear that given van Grinsven's background he would even understand why such behavior is unethical. 

Summary

As a physician, it is hard not to laugh at all this, at least to keep from crying.  As we have noted frequently, health care has been taken over by generic hired managers.  At best, while well meaning, many of them seem clueless about the nature and context of health care, and health care professionals' values.  At worst, the manager's coup d'etat has turned managers into manager-kings, queens and nobles, while driving up health care costs, and sacrificing the health of patients and the public.  The depth of this phenomenon is demonstrated by the absolute lack of skepticism about the worthiness of a former Ritz-Carlton executive to run either a community hospital or a system of cancer treatment centers.

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