Showing posts with label patient safety. Show all posts
Showing posts with label patient safety. Show all posts

Thursday, April 02, 2020

During the Pandemic, Follow the Money: Hospitals and Health Care Provider Organizations Put Money Ahead of Clinician and Patient Safety, Public's Health

As the coronavirus pandemic continues its relentless course, we see many examples of selflessness and courage. They come from huge numbers of people keeping their social distance, to those in essential work, including primary care and public health professionals, facing long hours and increased risk, to first responders and hospital based doctors, nurses and other health professionals facing even longer hours, more risk, and the sorrows of sick and dying patients.  We also see economic hardships to many, including layoffs, lost wages, and closed small businesses. 

However, in the commercialized and dysfunctional US health care system, whose theme, like that of The Apprentice, should be "For the Love of Money," we see some stark contrasts. 


[For the Love of Money, the O'Jays]

So to understand why things keep going so wrong, we need to follow the money.  Let us consider some recent cases, roughly in order of when they came to light.


Hospitals Fail to Order Ventilators for Predicted Surge in Coronavirus Patients

As reported by the Washington Post on March 18, 2020, the background is now all too familiar:

Mechanical ventilators, which help patients breathe or breathe for them, are considered critical to the nation’s effort to contain the worst effects of the pandemic and avoid a crisis like the one Italy is facing. Depending on how bad the coronavirus pandemic gets in the United States, individual cities could come up thousands of ventilators short as patients flood hospitals, researchers say.

However,

Orders have not flooded in, she said, because most hospitals can’t afford to increase inventory of expensive equipment for what could turn out to be a short-term event.

'The risk is that they’ll never be used, and hospitals can’t eat the cost,' she said. 'Most hospitals in this country are not profitable.'

And why do hospitals not have any extra ventilators in case of a surge in demand?

Keeping backup ventilators is impractical for most hospitals because of the need to service and maintain them and train additional staff during rare events when they are needed, said Lewis Kaplan, a trauma surgeon at the University of Pennsylvania and president of the Society of Critical Care Medicine.

'It’s like taking military planes out of your boneyard,' he said. 'There can be a variety of economic disincentives to be prepared for the worst thing that can happen.'

Left unsaid is how the dollars saved might be balanced against any lives that could be lost were backup ventilators unavailable. Left also unsaid is whether the hospital could have bought the ventilators by using money earmarked for other purposes, like public relations, marketing, or increasing the compensation of top executives.   

Note that these comments came from early March, before US hospitals were overwhelmed.  They suggest that hospital leadership was not willing to sacrifice the short-term bottom line to be better prepared for a catastrophic event, despite, the mission of the hospital that should place the care of patients first, way ahead of short-term financial issues.

The reason is likely that most hospitals, like other health care organizations, are in the grip of managerialism.  Per an article from the June, 2015 issue of the Medical Journal of Australia (look here):
- businesses of all types are now largely run by generic managers, trained in management but not necessarily knowledgeable about the details of the particular firm's business
- this change was motivated by neoliberalism (also known as economism or market fundamentalism)
- managerialism now affects all kinds of organizations, including health care, educational and scientific organizations
- managerialism makes short-term revenue the first priority of all organizations
- managerialism undermines the health care mission and the values of health care professionals

The dangers of managerialism are becoming more apparent in this era of the pandemic.

Hospitals Still Allowing Elective Procedures, Despite Use of Resources that might be Needed for Pandemic Preparation, and Risks of Disease Transmission

An anonymous post on the KevinMD blog on March 24, 2020 suggested that hospital managers are pressuring doctors to do elective procedures, despite guidelines suggesting such procedures should be on hold during the pandemic:

Despite the guidelines issued from the American Society of Anesthesiologists, The Anesthesia Patient Safety Foundation, The American College of Surgeons, and the Center for Disease Control, many hospitals are continuing with elective cases during the COVID-19 crisis. Or worse, they are hiding behind the facade of canceling or postponing elective cases. At many hospitals, a tiered system of urgency allows leeway to surgeons or family to manipulate or distort the urgency by overplaying symptoms.

Furthermore,

For many of you, your hospital administration has forced your hand to continue operations or made examples of you if you disagree. There is pressure from your chiefs who are also likely being intimidated at the risk of losing their jobs.

The author noted that continuing elective surgery has risks, and gets in the way of pandemic preparedness

In addition to gambling on my very existence, every case you participate in that is not absolutely necessary right now is putting your community at risk. We do not have the luxury of practicing social distancing in our job. Every family that comes into the hospital is a potential vector for this virus, and we have no choice but to do the cases and then potentially spread this to our patients or our own family. We are sending mixed messages to our family by encouraging them to stay home in every aspect except this one. Every case you leave on the board requires us to use gloves, gowns, masks for all parties in the operating room. In addition, we must use anesthesia circuits, airway interventions, and medication that will be critically important in the coming days. As I alluded to earlier, even cases that do not typically require intubation might require it. In the same vein, intubation does not guarantee extubation. You must consider that your patient may need postoperative ventilation.

The implication is that the hospital managers are putting short-term revenue ahead of patient and health care professional safety, and using intimidation to do so.  Why? See the comments on managerialism above.

Within days, specific examples of the pressure by hospital management to continue performing elective procedures have appeared.

For baseball fans: on March 31, 2020, NJ.com reported:

On March 19, the Boston Red Sox learned ace Chris Sale needed Tommy John surgery. Five days later, New York Mets right-hander Noah Syndergaard found out he needed Tommy John surgery as well. Syndergaard went under the knife two days later. Sale had his operation on Monday, according to the Boston Globe.

There was no question both procedures were elective

When Red Sox chief baseball officer Chaim Bloom announced Sale’s impending surgery, he admitted the southpaw’s operation was elective. 'Obviously something we’re mindful of,'

Syndegaard's surgeon tried a little spin:

One of Syndergaard’s doctors said the right-hander’s operation was completely justified. According to the Mets, Dr. Neal ElAttrache gave Syndergaard a second opinion and defended Syndergaard going under the knife because the 27-year-old pitcher’s 'livelihood is at stake.'

The teams apparently set up the procedures to avoid hospitals and states where they were discouraged.

Each state has its own standards for medically-necessary procedures. Syndergaard went to Florida for his operation because at the time, the Sunshine State was allowing such operations whereas New York was becoming the epicenter of the coronavirus fight.

The Boston Globe reports Sale went to California for his operation because of the state’s lack of restrictions on procedures. His operation was performed by Dr. ElAttrache, who as we said, sees no problem with these surgeries.

In the modern sports world, team owners have shown they are in it for the money.  However, the physicians and doctors who collaborated to provide obviously elective surgery on wealthy, high-profile athletes also seemed to be putting money ahead of the public's health.

Some hospital systems seemed particularly cavalier about elective procedures. On April 1, USA Today reported,


This month, nearly 300 University of Pittsburgh Medical Center medical staff members – the majority of them residents and anesthesiologists – signed a seven-page letter outlining concerns about elective surgery and routine visits. It was sent to the health systems' management March 21, but some elective procedures have continued, according to two doctors who asked to remain anonymous.

Employees reported backlash from management because of the letter, one of the doctors said.

A second example,

Facilities allowing nonemergency surgeries include Steward Health Care. The more than 30-hospital chain, which operates in states including Texas and Louisiana, said in a statement that it will 'continue to support all scheduled surgeries and procedures, and we will leave the decision on whether it is appropriate to proceed now to our physicians and their patients.'

Steward said it is 'committed to preserving access to scheduled procedure time for as long as possible.' Steward did not respond to a request for comment Tuesday.

Just to reiterate,

Doctors and hospital staff 'have been put in a situation of deliberate sacrifice and are told to put our personal safety aside for monetary reasons,' said [Dr Nivedita] Lakhera, who has written two books on mental health and healing. 'When hospitals do nonemergency procedures, we see them as being OK with our death over their greed about short-term revenue. We resent that, but we are powerless, and we are forced to be there anyway.'

Note that UPMC is something of a poster child for managerialism in health care.  We have frequently discussed the hospital system management's ethical misadventures, led by a business-trained generic manager who has received outlandish compensation.  Our most recent round-up of the troubles at UPMC was in 2015.  

Furthermore, note that Steward Health Care is actually a for-profit hospital system owned by a private equity group, Cerberus Capital Management.  Thus it exemplifies another feature of the US commercialized health care system, financialization.  Steward Health Care, as run by Cerberus, was one of the earlier leaders in hiring corporate physicians, whom it pressured to avoid "leakage" of patients to other hospitals and doctors, even if some might question whether the care provided elsewhere might be better for those patients (look here).  The multimillion dollar a year CEO of Steward suggested the health care had become a commodity, objectionable to those who thought that health care should be a mission-based calling (look here). A 2016 summary of Steward's operational misadventures is here. As an aside, Steward was caught up in a dodgy scheme called World Health Networks to sell travelers quick analyses of their health via kiosks.  The scheme involved shady foreign participants, and a number of associates of ... Donald Trump (look here). 

Despite their sometimes dark pasts, both UPMC and Steward have remained major hospital systems, so maybe it should be no surprised that they are now seen as involved in ethically dubious activities that are hampering coronavirus preparedness, and possibly putting patients and health care professionals  at risk.


Hospitals Cutting Pay of Frontline Health Care Professionals Who Are at Personal Risk from Coronavirus

On March 27, 2020, the Boston Globe reported:

Emergency room doctors at Beth Israel Deaconess Medical Center have been told some of their accrued pay is being held back. More than 1,100 Atrius Health physicians and staffers are facing reduced paychecks or unpaid furloughs, while pay raises for medical staff at South Shore Health, set for April, are being delayed.

In particular, at the Beth Israel Deaconess Medical Center,

the physicians group announced that effective April 1, it is suspending employer contributions to the retirement plan for doctors in the group, as well as at an affiliated group that staffs many other hospitals in the state, Associated Physicians of Harvard Medical Faculty Physicians at BIDMC. There are 1,600 doctors in both groups, and the majority of them are affected by the cutback, according to a company spokesperson.

The physicians group also told ER doctors this week that it is withholding and deferring half of their quarterly 'bonuses' scheduled for March 30, according to another e-mail shared with the Globe. Those payments, which can reach tens of thousands of dollars per quarter, are based on extra shifts or additional patients the ER doctors took on months earlier, according to the doctors.

'The bonus is just pay we’ve earned,' [ED Doctor Matt] Bivens explained. 'It’s analogous to re-branding ‘overtime pay’ as ‘your bonus.’' Meanwhile physicians in other specialties in the group will not be receiving bonuses at all on March 30, according to the e-mail.

However,

'This is at a time when many of us have moved out to live like lepers separate from family to prevent spreading infection, and have already been working huge extra hours trying to scrape together [personal protective equipment] and otherwise brace for COVID-19,' said Dr. Matt Bivens, an ER doctor at Beth Israel Deaconess Medical Center and St. Luke’s Hospital in New Bedford.

What was the rationale? The need to preserve short-term revenue, of course:

'Like many other health care and physician organizations, the economics of the care we provide has changed quickly and dramatically,' wrote Dr. Alexa B. Kimball, chief executive of the Harvard Medical Faculty Physicians group practice at Beth Israel Deaconess Medical Center

I could find nothing in the article suggesting that the hospitals were cutting the pay of management personnel, however.  It seems particularly egregious to cut the pay of the health care professionals working the hardest and exposed to the most risk from coronavirus, while leaving the pay of already extremely well-compensated managers intact (if that is, in fact, the case).  But that's how the managerialist cookie crumbles....

Private Equity Owned Physician Staffing Company Cutting Pay of Front-Line Health Care Professionals Who Are at Personal Risk from Coronavirus

On March 31, 2020, ProPublica reported:

Most ER providers in the U.S. work for staffing companies that have contracts with hospitals. Those staffing companies are losing revenue as hospitals postpone elective procedures and non-coronavirus patients avoid emergency rooms. Health insurers are processing claims more slowly as they adapt to a remote workforce.

'Despite the risks our providers are facing, and the great work being done by our teams, the economic challenges brought forth by COVID-19 have not spared our industry,' Steve Holtzclaw, the CEO of Alteon Health, one of the largest staffing companies, wrote in a memo to employees on Monday.

The memo announced that the company would be reducing hours for clinicians, cutting pay for administrative employees by 20%, and suspending 401(k) matches, bonuses and paid time off. Holtzclaw indicated that the measures were temporary but didn’t know how long they would last.

In a follow-up memo sent to salaried physicians on Tuesday night, Alteon said it would convert them to an hourly rate, implying that they would start earning less money since the company had already said it would reduce their hours. The memo asked employees to accept the change or else contact the human resources department within five days “to discuss alternatives,” without saying what those might be. The memo said Alteon was trying to avoid laying anyone off.

'It’s completely demoralizing,' said an Alteon clinician who spoke on the condition of anonymity. 'At this time, of all times, we’re putting ourselves at risk but also putting our families at risk.'

So many ED physicians are neither private practitioners or hospital employees, but work for medical staffing companies, to whom hospitals have outsourced ED functions.  Presumably, hospital managers did this based on management dogma favoring outsourcing as a way to increase financial efficiency, thus improving the hospitals' revenue.  Here we see managerialism in action once again.

But wait, there is more.... It is not merely that the ED physicians in this case are employees of an organization led by managers with business training, but no health care background.  In fact, they work for for-profit companies owned again by private equity firms:

Private equity investors have increasingly acquired doctors’ practices in recent years, according to a study published in February in JAMA. TeamHealth was bought by Blackstone Group in 2016; another top staffing firm, Envision Healthcare, is owned by KKR. (The staffing companies have also been implicated in the controversy over 'surprise billing.')

What about Alteon?

Alteon and its private-equity backers, Frazier Healthcare Partners and New Mountain Capital, didn’t immediately respond to requests for comment.


ED clinicians now faced with pay cuts while they work harder, face more hardships, and are subject to more risks, were not happy.

'It’s completely demoralizing,' said an Alteon clinician who spoke on the condition of anonymity. 'At this time, of all times, we’re putting ourselves at risk but also putting our families at risk.'

So,

'I’ve completely lost trust with this company.'

The big question is why that clinician ever thought a private equity company would put patient care, and patient and clinician safety ahead of its own revenue?

We first discussed the perils of private equity takeovers of hospitals here in 2010, and of physicians providing direct patient care as employees of corporations owned by private equity here in 2011.   The private equity business model seems particularly unsuitable for organizations which provide patient care, as we discussed in some detail in 2012.

For a quick modern summary of why it is bad to have private equity involved in direct patient care, see Merrill Goozner writing in Modern Healthcare, September 5, 2019,


The private equity business model in healthcare parallels other industries: Use highly leveraged private capital to roll up a number of small firms into one entity, with the private equity firm providing collective management. In addition to hefty fees for arranging the transaction (generally 1% to 2% of the purchase price), the private equity firm typically demands a 20% return on its investment after paying interest on the debt.

After three to seven years, assuming all goes well in achieving the promised efficiencies, the private equity firm and its junior partners (who are the specialty physicians in this latest wave of takeovers) earn a windfall by taking the company public or flipping it to another set of private equity investors. If things don’t work out as planned, the firm cuts its losses and declares bankruptcy (most of its capital will have been recouped through the 20% annual returns).

The management company has two paths to achieve its financial targets. It can either reduce costs sharply or look for ways to increase revenue.
A private equity firm running a hospital is likely to be even more focused on putting short-term revenue ahead of all else, including patient's and the public's health, and ahead of health care professionals' safety and welfare.

Summary

We have been ranting about the perils of the US commercialized, dysfunctional health care system for a long time, unfortunately often with little effect.  But expect these perils to loom very large when the health care system and the nation's public health are under a deadly threat, like that from a pandemic.  I hope most of us will survive this pandemic.  When it is over, we have to rethink our societal devotion to neoliberalism, (or market fundamentalism) (look here).

We could start by banning the commercial practice of medicine, as we did in the past, and banning for-profit corporations from owing hospitals, or providing direct care to patients.

Until we do, we will continue to live in a dystopic version of The Apprentice.

 

Friday, September 05, 2014

EHR safety, a false sense of security, and epistemological problems in the Medical Informatics community

Neil Versel is an author of many articles about healthcare information technology.  He recently published "Patient safety in the balance: Questions mount about EHRs and a wide range of patient safety concerns" (http://www.healthcareitnews.com/news/patient-safety-balance) in Healthcare IT News,

a sidebar on my views "A 'false sense of security'" (http://www.healthcareitnews.com/news/false-sense-security).

I thought my feedback back to him would be of interest, centering on a published comment of the typical hyper-enthusiast variety made by a prominent member of my Medical Informatics professional community.  The view exemplifies a widely-held but erroneous (and decidedly non-scientific) viewpoint in my professional community - and many others, including government -  regarding drawing conclusions in the face of significant evidentiary gaps and impediments regarding harms.

Here are my emails to Mr. Versel.  They speak for themselves, especially the short second supplementary email seen at the bottom of this blog post

-- SS

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


EMAIL #1:

From: Silverstein,Scot
Sent: Friday, September 05, 2014 10:05 AM
To: Neil Versel
Subject: Re:" A 'false sense of security'"

Neil,

Thanks for citing me in your article at http://www.healthcareitnews.com/news/patient-safety-balance, http://www.healthcareitnews.com/news/false-sense-security etc.

Want to call your attention to one of my largest disappointments and frustrations in health IT that evolved over the past decade or two, namely, cheerleading for the technology in the face of commonly understood Western science and epistemology ("the theory of knowledge, especially with regard to its methods, validity, and scope. Epistemology is the investigation of what distinguishes justified belief from opinion").

My concerns are best exemplified by the comment posted at the article site by a prominent member of my Medical Informatics professional community:


"The question is not whether EHRs are safe or not; sometimes they are, and sometimes they are not. The real question is whether they are safer than paper records, and the weight of scientific evidence is that they are."

The actual truth, considering the explicit statements with explicit reasons given by IOM, FDA, ECRI, and others as to why what we know about electronic harms is incomplete ("tip of the iceberg", see below), is that "while the potential for electronic systems to be safer than paper exists, the scientific evidence is inadequate to make any statement about comparative safety on the ground."

The data inadequacy is made far worse by the known and stated systematic impediments to discovery and diffusion of the harms, and a lack of robust studies on ACTUAL harms due to paper-based record keeping, especially and critically regarding optimal and well-staffed paper systems.  (Try a Medline search on that topic!)

The hyper-enthusiasts who favor the theoretical over reality on the ground and who push for speedy national rollout without proper safeguards, surveillance and regulation, are, in fact, killing people. [I.e, whose injuries and deaths at the hands of bad health IT were otherwise preventable had appropriate industry safeguards been in place - ed.]

There is actually nothing to argue, nothing to debate on this issue.

Some material backing up these assertions is below, mostly already covered in my blog-based 11 points.  [As at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html - ed.]

Cheers,

Scot

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



Examples: 

1)  IOM report on HIT safety, 2012 (as I report at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html , midway down):


.. While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.
Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.[IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press, pg. S-2.]

Also in the IOM report:


… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.
More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”

2)  FDA Internal memo on HIT risk, 2010 (as i report at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html):


... In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications.


  This is especially true considering the FDA's own noted limitations of their information sources:




Limitations of the MAUDE search and final subset of MDRs include the following:

1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including
... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.
2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.
3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.
Memo: H-IT Safety Issues
4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.
5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.


3)  Jeff Shuren MD JD, head of FDA CDRH (as I report at http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html):


The Office of the National Coordinator for Health IT held a meeting of the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010. The topic was "HIT safety." The agenda, presenters and presentations are available at this link.

At this meeting FDA testimony was given by Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health. Dr. Shuren noted several categories of health IT-induced adverse consequences known by FDA. This information was striking:

He wrote:


... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

Even within this limited sample, several serious safety concerns have come to light. The reported adverse events have largely fallen into four major categories: (1) errors of commission, such as accessing the wrong patient’s record or overwriting one patient’s information with another’s; (2) errors of omission or transmission, such as the loss or corruption of vital patient data; (3) errors in data analysis, including medication dosing errors of several orders of magnitude; and (4) incompatibility between multi-vendor software applications and systems, which can lead to any of the above.

4)  ECRI Institute Deep Dive study of health IT safety (as I report at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html):

Participating facilities submitted health IT related events during the nine-week period starting April 16, 2012, and ending June 19, 2012. ECRI Institute PSO pulled additional health IT events that were submitted by facilities during the same nine-week period as part of their routine process of submitting event reports to ECRI Institute PSO’s reporting program. The PSO Deep Dive analysis consisted of 171 health IT-related events submitted by 36 healthcare facilities, primarily hospitals

(There were 8 injuries and 3 possible deaths associated with these 171 IT-related events over just 9 weeks, suggesting a damn serious problem way ahead of paper errors.)

5)  Statement by Medical Director of ECRI, same link as above:

Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  The volume of errors in the voluntary reports was she says, "an awareness raiser."

"If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."

6)  ECRI's continuing concerns based on continuous data submitted by their PSO member hospitals that health IT systems are "one of the top ten (and in fact in 2014, risk #1) technology risks in healthcare" (as I report at http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html)


This is a short list, but you get the idea about making any statements about comparative risks of paper v. electronic.

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

EMAIL #2: 

 From: Silverstein,Scot  
Sent: Friday, September 05, 2014 10:08 AM
To: Neil Versel
Subject: RE: Re:" A 'false sense of security'"

Not to mention that the "real" question is NOT "whether they [electronic systems] are safer than paper records."

The real question is:  is it ethical, based on the current clinical reality and incomplete state of knowledge, to push this technology on patients?

I also could add to that question:  "...especially without informed consent?"

Scot


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

-- SS  

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
Browser Safari 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 Visit Jun 13 2014 11:47:42 am
Last Page ViewJun 13 2014 11:47:42 am
Visit Length0 seconds
Page Views 1
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 Zone UTC-6:00
Visitor's TimeJun 13 2014 10:47:42 am
Visit Number 1,342,222

 -- SS

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

Tuesday, March 25, 2014

This EHR "glitch" killed three-year-old Samuel Starr - but patient safety was not compromised

Actually, safety was compromised.

I have written repeatedly that the term "glitch", an often-seen euphemism (usually accompanied with the phrase "but patient care/patient safety was not compromised"), is really a term for life-threatening health IT bugs and malfunctions.  See query link http://hcrenewal.blogspot.com/search/label/glitch for examples of health IT "glitches" (retrieves multiple posts).




Here's a "glitch" that tragically killed this boy:

Three-year-old boy dies after new NHS computer system delays heart treatment

Mar 05, 2014
By James Tute

http://www.mirror.co.uk/news/uk-news/samuel-starr-death-nhs-computer-3209365

Coroner Maria Voisin rules that new booking system meant he did not receive life-saving treatment

A three-year-old boy died in his parents' arms after a new NHS computer system failed to schedule him for a vital heart scan, a coroner has ruled.

Samuel Starr was born with a congenital cardiac defect and needed surgery not long after he was born in 2010.

Although he made a good recovery doctors said he would need regular tests to check on his progress.

But he did not have a scan until 20 months after his first major operation because of a delay following the introduction of a new computer system, Cerner Millennium.

When he finally had the appointment doctors found Samuel needed open heart surgery. During the procedure, Samuel had a stroke.

A month later, after further complications, he died in the arms of his devastated parents, Catherine Holley and Paul Starr, at Bristol Royal Hospital for Children.

There are some in my field who would (and have) called incidents like this "anecdotes" or "bumps in the road."

Yet, as I've recently posted, an internationally-renowned healthcare safety tester, ECRI Institute (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html), and the medical malpractice insurer of the Harvard medical community, CRICO (http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html), have confirmed cases like this are no mere anecdotes.  I estimate from their numbers, and from cases known to me personally and from descriptions of others, that on the order of ten thousand (that's likely low) patients annually are being injured and/or die as a result of bad health IT in the U.S. alone.  Lack of transparency about such incidents impairs knowing the true numbers.

Ms Holley wept as she told the hearing of the moment she kissed her son goodbye, saying: "He was a kind and gentle boy with a great understanding of the world.

"As we read Samuel his favourite stories, he died in our arms."

Avon Coroner Maria Voisin, recording a narrative conclusion, ruled the booking system meant Samuel was not seen and did not receive treatment.

This case somewhat reminds me of the case of a newborn whose x-ray test was done, but never looked at due to a bug in the software that scheduled films to be read, see http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html, case #2

Concluding a three-day inquest at Flax Bourton Coroner's Court in North Somerset, Ms Voisin said: "Samuel Starr was born with a complex cardiac disease. "He required surgery and regular check-ups at outpatients to manage his conditions.  "Due to the failure of the hospital outpatients booking system there was a five month delay in Samuel being seen and receiving treatment. "Samuel's heart was disadvantaged and he died following urgent surgery."

Just a "glitch."

Doctors diagnosed that Samuel had a restricted pulmonary artery - causing blood to easily flow away from his heart to his lungs - during a 20-week scan in pregnancy ... On March 3, 2010, Samuel underwent open heart surgery at Bristol Royal Hospital for Children. He was discharged six days later and referred to the Paediatric Cardiac Clinic at the Royal United Hospital (RUH) in Bath for check-ups.

In October 2010, Samuel had his first check-up, in which an echocardiogram, also known as an "echo", was carried out. Ms Holley said she was told the procedure would be next carried out early in the new year.

But it did not happen until April 2011 and an echo was not performed.  Paediatric cardiologist Dr Andrew Tometzki told the inquest he did not "deem it necessary" on that day to carry out the echo scan. Dr Tometzki then ordered a further review - where an echo scan would be carried out - in nine months' time.

Samuel's parents did not receive information about the check-up and raised their concerns with community children's nurse Clare Mees.

Ms Mees, who works for Sirona Lifetime Services, said she would chase up the matter with Dr Tometzki's secretary.

Medical secretary Annabelle Attridge insisted she had taken details and forwarded them on to a dedicated appointments team.

However, the inquest heard "glitch problems" with a new booking system meant the appointment was not logged. 

Apparently not due to human fault:

Paediatric clinic co-ordinator Donna McMahon said while Samuel's medical records had been created on the new Millennium computer programme, no appointments had been transferred across.

Just a "glitch."  Just a "bump in the road."

Ms McMahon said she was first aware of the appointment delay when she received an email from nurse Ms Mees in May 2012.

Samuel did not have the vital check-up until June 21.

Coroner Ms Voisin added: "This overall failure led to a five month delay in Samuel being seen by his cardiologist.

"This meant Samuel had not been seen for five months and had not had an echo for 20 months."

His parents were horrified when Dr Tometzki informed them Samuel required heart surgery that spring.

Just a "glitch."  Just a "bump in the road."

... "Just hours before his operation Samuel was dancing around the ward and telling the nurses all about Spiderman - we had to remind him to quieten down," Ms Holley said.

Samuel's chest was closed on August 8. As he was brought out of sedation on August 9, he suffered a stroke and cardiac arrests.

"It is clear that if the surgery had been performed earlier, the procedure would have been the same," Ms Voisin said.

But she said expert evidence found that as time went on "the more complicated the surgery is, as the more disadvantaged the heart is and the more difficult it is to get over the operation".

Delays in care of fragile patients - in this case a young child, but in many other cases, ED and ICU patients of all ages - is very unwise.

Samuel's condition continued to deteriorate and on September 6 his parents were recommended for treatment to be withdrawn after he had a second cardiac arrest.

The coroner said she would not write a report making recommendations to the hospital, as changes had already been implemented.

Likely, workarounds to bad health IT, inviting future catastrophe.

In my view, many cases such as this never make headlines, as the findings ignore the role of the IT and blame people, cases are settled with gag clauses, patients (who survive) or family are never told of the role of the IT, or lawsuits prove too expensive or too unpleasant to pursue.

But patient safety is never compromised by "glitches", and regulation will just stifle innovation.

My condolences to the parents.  I've suffered a death in my own family as a result of health IT, and I'm a specialist in the field.  Laypeople have no chance.

One should pray the next child affected in this way is not one's own.

-- SS

Mar. 25, 2014 addendum:  

Also see these related posts, the first mentioning "teething problems", another euphemism for potentially-deadly EHR malfunctions:

Cerner's Blitzkrieg on London: Where's the RAF?
 http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html 

North Bristol Hits Appointment Problems: Another "Our Lousy IT Systems Screwed Up, But Patient Safety Was Never Compromised" Story
http://hcrenewal.blogspot.com/2012/01/another-our-crappy-computers-screwed-up.html

-- SS

Tuesday, February 18, 2014

To Die in Texas - Dr Mahmood's Apparently Fatal Stealth Hospital System Collapses Nearly Anechoically

I would bet that most people in the US still think our health care system is highly regulated.  Some may thus conclude that the system is basically safe, because, for example, drugs have to be proven safe and effective to be approved by the government, and hospitals must be licensed and run by competent people who are thoroughly vetted.  Of course, some people still think that the US has, or had until recently, the best health care system in the world (look here).

Furthermore, the view that less regulation is always better is no quite popular in the US and elsewhere.  For example, after the chemical spill threatened water supplies in the capitol of West Virginia, the Dallas News reviewed Texas Governor Rick Perry's consistent attacks on government regulation.   

'American business in general, and American agriculture specifically, have had enough of bureaucracy at both the federal and state levels, but especially bureaucracy out of Washington,' Perry said at a congressional hearing. 'The men and women who feed and clothe this nation are suffocating under the weight of mounting federal regulations.'

That was back in 1993, when Perry was Texas’ agriculture commissioner. Now Texas’ longest-serving governor, Perry has remained steadfast in his opposition to government regulations.

Some who take such a neoliberal stance may say the health care system is over-regulated, and thus is inefficient and not innovative, leading to our high costs and poor access.

However, an amazing case out of Governor Perry's Texas that was made public last year, and I regret I just heard about recently, suggests how little health care may be regulated, and how unregulated health care, whether or not it is efficient, may be deadly.

As reported in the Dallas News, July, 2013, in the last few years there seems to have been an epidemic of quality problems in a number of seemingly unrelated small rural Texas hospitals.  The report focused first on one hospital,

Renaissance Hospital Terrell

After for-profit hospital corporation Renaissance Healthcare declared bankruptcy in 2008 (look here), it sold its hospital in Terrell, Texas to RH Terrell Management LLC owned by one Dr Tariq Mahmood.  Almost immediately, however, there was trouble.  First Edwina Henry, the quality director, spied a doctor making questionable entries in patients' charts:

from her office, she had a clear view of doctors’ foot traffic through the medical records department.

When she saw [Dr Tariq] Mahmood jotting in patient charts, she knew he wasn’t seeing patients. Mahmood himself had not been credentialed to treat patients — a process in which management vets backgrounds and competencies of doctors. Part of Henry’s job was tracking such evaluations. She also knew it was a breach of privacy laws to review patients’ medical records.

'I immediately questioned some of the clerks and [insurance billing] coders,' she said. They were deeply concerned, saying he was altering the patients’ records to help boost reimbursements for insurance claims, Henry said.

When Ms Henry complained, things did not go well,

Henry made her confidential call to the bankruptcy court in early November 2008, alleging potential fraud and threats to patient care that were eluding government notice [Ed - note that the hospital was going through bankruptcy proceedings and had just been acquired by a new owner]. The court forwarded her complaint to the U.S. Justice Department, the Texas attorney general’s office and the state health department, officials confirmed.

Later that month, the state health department sent an inspector to the hospital. However, the visit was brief, Henry said, and the inspector didn’t interview her or seek her help in obtaining records.

Williams, the health department spokeswoman, told The News her agency’s records show the inspector was unable to substantiate violations at the time.

Henry was terminated from Renaissance as part of a 'restructuring'....
Then the hospital was cited for turning patients away from the emergency department,
At Renaissance, two women in labor, one bleeding, were refused treatment. The inspection reports don’t reveal whether the women suffered complications because of the delays.

A Renaissance employee told one of the women that if she 'could stand there and have a conversation with them then (she) wasn’t about to have a baby,' reports say.

Then there were problems with infection control,

At Renaissance, no supervision over infection control could be found. For three months in the summer of 2010, no one was in charge of tracking infectious diseases or preventing their spread.

The next year, the problem was blood transfusions

Inspectors returned to Renaissance in September 2011 to investigate a botched blood transfusion procedure. They found that a registered nurse had not supervised the patient’s care. In another case, an inspector witnessed an unsupervised vocational nurse administering blood to a patient, despite no evidence that she was competent to do so — another violation.

In 2012,

During the summer, the Texas secretary of state had revoked Renaissance’s business charter for failure to pay franchise taxes.

That office didn’t share the information with the health department; it isn’t required to do so.

In September, state health regulators notified Renaissance that they were proposing a $35,050 fine for 13 violations, including the nursing supervision failures, dating as far back as 2010.

Williams, the health department spokeswoman, could not explain why the fine process took nearly two years since the first violation. 

Finally, in 2013, patients started to die,

In January of this year, when state inspectors returned to Renaissance, they found nursing supervision failures yet again.

This time, the failures had led to three deaths: All ER patients. All with severe breathing difficulties. All receiving little to no intervention as their conditions worsened.

In particular,

[Eve] McCallum sought her own care after complaining of shortness of breath during a family dinner.

McCallum had chronic obstructive pulmonary disease. When she was admitted, nurses were ordered to monitor her vital signs and oxygen levels. Her breathing soon improved, said her niece, Lou Ann Sims.

'We were fully expecting to pick her up the next morning,' Sims said.

Instead, they watched helplessly as her condition deteriorated. On Christmas Day, a physician explained to McCallum’s family that she had to be transferred to the intensive care unit.

Later, Sims witnessed a scene she can’t let go of: Her aunt lay connected to a ventilator while a nurse stood smoking a cigarette just outside the door. The nurse had propped open the door with an IV pole.

The family immediately sought to have McCallum transferred to another hospital. But hospital officials told them 'this would be a lateral move and was not allowed,' according to a transcript of an interview the family later conducted with state officials.

McCallum died two days later.

Inspectors wrote that a licensed vocational nurse had been left in charge of her treatment, without a registered nurse’s oversight. There was no evidence an RN had assessed her condition on admission or was watching over her in the ICU.

They could find no doctor orders to place her on oxygen, no order for medications administered to her, 'nor evidence of communication with the M.D.'

Suspecting more than just care breakdowns at Renaissance, McCallum’s family reported her death to the Texas attorney general’s fraud-control unit.


So partially in response to this egregious case,

By February, the state health department had moved to revoke Renaissance’s operating license, and CMS had ordered its federal funding terminated — only the ninth time nationally in the last three years CMS had taken such a step.

Even those steps could not shut down the hospital, but city officials took that last step due to the failure to pay taxes.

Other Hospitals

Dallas News reporter Miles Moffeit found several other cases of severe problems at small hospitals owned by Dr Mahmood, with at least one patient death apparently resulting, .


Shelby Regional Medical Center

This hospital was owned by Tenet Healthcare, but was sold to another of Dr Mahmood's companies, Shelby Medical Holdings, in 2007 (look here). 

In 2009, this hospital was also cited for providing insufficient treatment in the emergency department.

In 2012, things were really falling apart,

In October 2012, inspectors were at Shelby chronicling dirty, clogged air-conditioners and failures to prevent ceiling plaster 'from falling into the patient food service line and contaminating food.' Those problems put patients’ safety in 'immediate jeopardy,' they wrote.

As inspectors roamed Shelby’s halls in December, the power suddenly went out in four buildings, though not in the main hospital facility itself. The electric bill hadn’t been paid. They found other debts stacking up, too — as much as $190,442 owed to as many as 79 service providers.

Signs of neglect were everywhere. Only three of 20 patient rooms inspected were 'fully functional for patient care,' they wrote. They found holes in walls, dirty and tattered curtains, and patients complaining of heat pouring from the faulty A/C system.

Finally, in 2013, another patient died,

On Wednesday, CMS cut off federal funding to ... Shelby Regional Medical Center in Center in East Texas after regulators said a patient rushed there by ambulance never received treatment from a doctor.

The ER physician wouldn’t leave his 'sleep room,' the inspection report said, resulting in the patient’s death. Regulators also cited the hospital for failing to vet backgrounds of doctors and nurses.

Apparently soon thereafter Dr Mahmood shut the hospital down due to "legal issues that ... [he] is facing," per the Shelby Light and Champion.


Lake Whitney Medical Center

Dr Mahmood apparently purchased this hospital from a struggling local hospital authority in 2007.  

In 2009, it was cited for inadequate care in the emergency department,

At Lake Whitney, a nurse acknowledged to inspectors that she had shredded records of a patient who was denied care following a fall, according to a report. The 'patient wasn’t going to pay anyway,' the nurse was quoted as saying in the document.

In 2010, there was evidence of major infrastructure problems,

At Lake Whitney, patients were served food on rusty 'over-the-bed tables that were a source of possible infections for open wounds.' Bulging ceiling tiles exposed pipes. Pavement outside a main hospital door was 'cracked and unlevel,' putting patients at risk of injury.
As Dr Mahmood's legal troubles mounted, the hospital was sold to Frontier Hospitals Inc (look here).


Cozby-Germany Hospital 

I have been unable to discover when Dr Mahmood purchased this hospital. 

In 2010, it became apparent that the hospital was not properly licensed,

'The administrator reported the new owner had not notified (CMS) … and has not applied for hospital licensure with the state licensing agency,' a report said. [The owner] ... also was found to have appointed his own employees to the hospital’s governing board of directors, instead of independent outsiders.

And there were more severe problems with credentialing,

At Cozby-Germany hospital, hospital inspectors discovered that the chief of staff and another doctor had expired medical licenses. There were no 'functional' nurse and doctor credentialing processes, and clinical policies had not been updated since 2008, they said. The hospital pledged reforms.

But in May 2011, records show, Cozby hired one of Texas’ most notorious doctors, Rolando Arafiles.

At the time, Arafiles had been placed on probation by the medical board for allegations of harming nine patients, overbilling and improper coding at a Winkler, Texas, facility, according the board. He also was disciplined for intimidating the Winkler nurses who blew the whistle on his practices.

In November, Arafiles would be convicted of two felonies linked to the retaliation and would surrender his license.

In 2013, two local doctors purchased the hospital.

The Vanishing Owner

What made this series of cases all the more amazing is that it was really one interlinked case.  All these hospitals, plus a few more, had the same owner.  Yet no one, especially  no one in state or federal government knew that until 2013 when the facts were uncovered by Mr Moffeit.

[Dr Tariq] Mahmood, a Pakistan-trained doctor, obtained his Texas medical license in 1978. Since 2008, he has practiced medicine only at his Central Texas Hospital in Cameron, south of Waco, records with the Texas Medical Board show. Older documentation is not available.

Over the last two decades, he has purchased at least six hospital companies and two home-health care agencies, according to filings with the Texas secretary of state. He also has invested his money outside health care, acquiring the historic Hotel Lawrence in downtown Dallas, property records show.

In addition to Renaissance, Shelby and Central Texas Hospital, Mahmood owns the Lake Whitney Medical Center in Whitney and Cozby-Germany Hospital in Grand Saline. He sold Community General Hospital in Dilley around the time of his arrest in April.

The hospitals have no common corporate identity and little or no website presence, making it difficult for anyone to know they are owned by Mahmood or are part of a chain.


However, much bout Dr Mahmood was mysterious, and the deliberate cultivation of mystery might have slowed the response to this case.

Mahmood is rarely seen in the communities where his hospitals are located, say business associates and city officials. Sometimes they catch a glimpse of him passing by in a chauffeur-driven car.

'He’s almost impossible to track down' to discuss business matters, said Tom Elliott, a director for a nonprofit company that owns the hospital building in Grand Saline. 'He lets his people do the talking.'

Mahmood is a mystery to many of his own employees. He works almost entirely behind the scenes, they say, focusing largely on the business side of his operations. He often is traveling or spending time at his 10,000-square-foot gated estate in Cedar Hill, they say.

'We see him maybe once a year,' said one of his hospital physicians. 'The employees say he doesn’t like confrontation. I say he just doesn’t like to communicate. He seems to live in a different world.'

Aftermath

 At some point, the shadowy Dr Mahmood may have to answer for all this, at least to some extent,

In April, federal authorities charged the 62-year-old Cedar Hill resident with defrauding Medicare and Medicaid programs through $1.1 million in false billings.

Mahmood is accused of directing employees at his Central Texas Hospital in Cameron to alter underlying information in insurance claims from his other hospitals. 'In many cases,' the indictment alleges, these were 'for patients he had never seen.' Mahmood pleaded not guilty, and his attorney said he denies all charges. He has declined repeated interview requests from The Dallas Morning News

Note, however, that these are charges of financial fraud.  They do not obviously have to do with poor quality care, risks to patients' safety, or the deaths of at least three patients as discussed above.

This case was so bad that even the current Governor of Texas, Rick Perry, a politician known for taking a small government, minimal regulation stance, at least said he was going to take some action, as reported again in the Dallas News,

The governor’s office has ordered a 'deep and comprehensive look' at health care facilities owned by Dr. Tariq Mahmood, whose chain of rural Texas hospitals avoided serious regulatory action despite years of endangering patients.

The inspector general for the state Health and Human Services Commission and one of the agencies it oversees, the state health department, will conduct separate investigations, officials said Friday.

And in February, 2014, the Dallas News reported that the chief financial officer of the Dr Mahmood's stealth hospital chain was also in hot water,

The top administrator of a chain of hospitals that collapsed under the ownership of a North Texas physician faces charges that he defrauded the federal government of nearly $800,000 in stimulus funds.

Joe White of Cameron rose from maintenance man to head administrator and chief financial officer over hospitals once owned by Dr. Tariq Mahmood. Now he joins Mahmood in facing the possibility of prison time.

Like Mahmood, who pleaded not guilty, White is accused of identify theft and bilking the federal government of health care dollars. White has yet to enter a plea.

Note that the CFO and apparently COO was not even a professional generic manager.  He was a former maintenance man  and operator of a Radio Shack store.. 

Dr Mahmood has not yet come to trial.  Many questions about the case remain unanswered:
 -  Did Mahmood the only person besides his CFO cum maintenance man in charge of all this, or did he have other backers,  cronies, associates?
-  What happened to the rigorous state investigation promised by Rick Perry?
-  Given that what went on harmed patients, and hence was not just financial manipulation, are there any civil lawsuits pending?  Are there any other criminal investigations?\

Furthermore, despite its egregious nature, this case was amazingly anechoic  The only national recognition I could find was in Paul Levy's Not Running a Hospital blog.  Seven months later, I could find nothing in the national media, nothing in medical and health care literature.  Despite the amazingly poor quality of care in evidence, despite the fact that patients died, I could find no cries of outrage from those who proclaim to support quality health care or patient safety. 


Summary

Dr Mahmood and his chief operating and financial officer collectively displayed leadership that was ill-informed (the COO/ CFO was a former maintenance man), incompetent (see the egregious health quality problems listed above), self-interested (note the size of Dr Mahmood's mansion versus how little was obviously spent on his hospitals), opaque and dishonest (note how Dr Mahmood's ownership of the hospitals was obscured), and allegedly criminal.  This leadership persisted over at least eight years until it culminated in cases of apparently needless patient deaths.  

The amazing case of the stealth for-profit hospital system run by Dr Mahmood, and how its combined problems failed for so long to get systemic regulatory notice hardly suggest that our health care system is heavily regulated, or that current regulation can be relied upon to reassure patients that all is well and that the system is safe.

In fact, in the case of Dr Mahmood, government regulators did not seem to even want to know too much about hospital ownership,

Top health regulators weren’t even aware Mahmood owned several hospitals until The News sought information about them earlier this year. Regulatory agencies aren’t set up to track problem hospital owners or hold them accountable. Nor do they look for patterns of care breakdowns inside hospital chains.

'We just don’t have that authority,' said David Wright, deputy regional administrator for CMS. The federal agency oversees the state health department’s inspections of federally funded hospitals. 'We can only address problems in stand-alone facilities.'


Furthermore, it appears that modern regulators have decided to become hospital managers' and owners' best friends,

The process allows hospitals to avoid sanctions if they cooperate. Hospitals submit “corrective action plans” to remedy failures. It can take months for state regulators to bring penalties such as fines against a facility. In the case of Renaissance, it took years.

'We want to do what’s in the best interest of the patients, and our regulatory philosophy is to get hospitals into compliance,' said Carrie Williams, spokeswoman for the Texas Department of State Health Services. 'We’re not in the business of shutting down hospitals. We will give them some leeway and work with them.'

Of course, this minimalist, light touch regulatory methodology may have made some sense in an earlier era when nearly all hospitals were small community not-for-profit organizations, non-profit academic institutions, or were run by local governments.  It seems quaint, and hopelessly out of date in an era when most hospitals are part of ever larger systems, now often owned for-profit corporations, and when hospital system CEOs who are professional, and thus generic managers, not health care professionals, in an era of financialization and "maximizing shareholder value," that is, making short-term revenue the most important outcome.

Instead, the current minimalist regulatory system seems insufficient to prevent patients from dying of poor care allowed by poor leadership of health care organizations.  Much of the content of this blog has been about bad health care leadership, i.e., leadership that is ill-informed, incompetent, unsympathetic or hostile to health care professionals' values, self-interested, conflicted, dishonest, or even corrupt.  In my humble opinion, health care regulation ought to be sufficient to promote competent, caring, unconflicted, honest leadership that is accountable for putting patients' interests ahead of self-interest.  Regulation needs to be more intense, and much smarter, geared to the reality of a health care system that is now largely for-profit in an era when management dogma puts revenue ahead of all other concerns.

Maybe the deaths of some patients in Dr Mahmood's Texas hospital will finally let the air out of the mindlessly anti-regulatory bubble, and start some discussion of intelligent regulation to improve patient safety.

However, that cannot happen if this case remains anechoic.  I regret it took me so long to find it, but now I have done my part to start some echoes.  But where are the media, where are the journal editors, and where are those who so loudly proclaim their interest in patient safety and health care quality?

In particular, there are several prominent organizations that claim to promote health care quality and patient safety.  These organizations make these claims-

Joint Commission

 For more than 60 years, The Joint Commission has been a champion of patient safety by helping health care organizations to improve the quality and safety of the care they provide.

Leapfrog Group

 The Leapfrog Group is a voluntary program aimed at mobilizing employer purchasing power to alert America’s health industry that big leaps in health care safety, quality and customer value will be recognized and rewarded.

National Quality Forum

 Transforming our healthcare system to be safe, equitable, and of the highest value will take time and the work of many, but the potential rewards are great. The National Quality Forum (NQF) is a nonprofit, nonpartisan, public service organization committed to this transformation.

Robert Wood Johnson Foundation

Our efforts focus on improving both the health of everyone in America and their health care—how it's delivered, how it's paid for, and how well it does for patients and their families.

These  organizations should the ones to start the conversation about improving rather than forever shrinking regulation.   I have not heard anything from them about the deadly hospitals of Dr Mahmood.  Are they listening now?  Will we ever hear from them?  Time will tell.... 

 Note: the entire Dallas News series on the Mahmood hospitals can be found here