10 Ekim 2012 Çarşamba

In addition to nurses, doctors now air their alarm: Contra Costa County health doctors air complaints about county's new $45 million computer system

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At my Aug. 2012 post "Contra Costa's $45 million computer health care system endangering lives, nurses say", I described how an experimental EHR being forced on clinicians in Contra Costa county, California, was endangering patients who had not consented to its use, and how nurses were reported to be raising hell about it.  I also noted:

... The[se] scenarios [of EHR-created mayhem] are also usually accompanied by amoral misdirection from these personnel away from patient risks...

Herein is the problem:  the attitude that a clinic full of non-consenting patients is an appropriate testbed for alpha and beta clinical software that puts them at risk is medically unethical, based on the guidelines developed from medical abuses of the past.  There is nothing to argue or debate about this. 

Now the affected physicians have their say.

These physicians are apparently represented by a union; therefore they likely fear retaliation less than non-union physicians, and thus can be candid:

Contra Costa County health doctors air complaints about county's new $45 million computer system
By Matthias Gafni
Contra Costa Times
Posted:   09/18/2012, Updated:  09/19/2012

MARTINEZ -- One of every 10 emergency room patients at the county's public hospitals in September left without ever being seen by a doctor or nurse because of long waits -- a number rising since implementation of Contra Costa's $45 million computer system July 1.

One patient waited 40 hours to get a bed.

Dr. Brenda Reilly delivered the troubling news Tuesday afternoon to county supervisors. She was one of three dozen doctors in the supervisors' chamber complaining about EPIC, new computer software aimed at integrating all of the county's health departments to create a federally mandated electronic medical record for patients.

The response, as seen later, were characterized by the typical amoral excuses, mistaken beliefs in technological determinism, (a/k/a quasi-religious computer fanaticism) and misdirection I described above.

To allow for the major computer program installation and conversion, administrators cut doctors' patient loads in half, in turn cutting the number of available appointments in half.

In a letter to the supervisors, Dr. Ori Tzvieli -- medical staff president whose union has been negotiating a new contract with the county -- along with 14 doctor co-signers pleaded for administrators to continue scaling back physician workloads because doctors are over-stressed. Six doctors have left this year, said Dr. Keith White, a 22-year pediatrician.

I point out that such stress from interacting woth a mission hostile EHR (really, a clinician workflow-control system), and the needed state of hypervigilance to avoid IT-related mistakes that harm patients, lead to burnout and ultimately, a lower quality of patient care. 

Patient workloads were reduced by 50%, which is bad enough (and indicative of gross project mismanagement, as I wrote about in another example in my Sept. 2012 post "Lake County (IL) Health Department: The extremes to which faith-based informatics beliefs can drive healthcare facilities - Depression era soup lines at the clinic?").

Yet the 50% reduction, according to the principal end users, was still not enough.  Usability and fitness of the software is surely in question.

"We were not ready for EPIC and EPIC was not ready for us," White told supervisors. "As a result, the providers are struggling to provide safe and effective care for 100,000 citizens of the county, many of whom are very ill. We often feel that we are failing. We are very tired ... many doctors have left and all are considering leaving."

It is impossible for people, especially medical professionals, to be "ready" for a system that "is not ready for them", i.e., "bad IT" as defined at my teaching site intro at this link:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.
   
Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

The two phrases "We were not ready for EPIC" and "EPIC was not ready for us" do not belong together in the same sentence.

A claim that physicians (and nurses) are "struggling" to provide safe let alone effective care for 100,000 should RAISE ALARM BELLS, not produce a paternalistic, patronizing response from medical and governmental officials as it did, seen below.

Both doctors and administrators agreed Tuesday that creating an integrated electronic health record is important, but a series of white coats stepped to the podium in what they jokingly termed "Doccupy" to share their nightmarish last few months.

I disagree with the assessment that "creating an integrated electronic health record is important", in that the technology and know-how to do so without endangering the very patients the technology is supposed to protect does not yet seem to exist in the commercial sector.

In that sense, regulating EHR technology and subjecting it to controlled clinical trials and refinement (as with any other medical device or drug, and many other types of healthcare-related IT such as MDDS - medical device data systems) with consenting subjects is what's important.

On MDDS, from the FDA link above:


Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS are not intended to be used for active patient monitoring. Examples of MDDS include:
  • software that stores patient data such as blood pressure readings for review at a later time;
  • software that converts digital data generated by a pulse oximeter into a format that can be printed; and
  • software that displays a previously stored electrocardiogram for a particular patient.
The quality and continued reliable performance of MDDS are essential for the safety and effectiveness of health care delivery. Inadequate quality and design, unreliable performance, or incorrect functioning of MDDS can have a critical impact on public health.

That health IT used on live patients receives special regulatory accommodation in the form of non-regulation, when clearly the quality and continued reliable performance of EHR systems are essential for the safety and effectiveness of health care delivery, is inexcusable in 2012.  

(Of course, stunningly, FDA won't touch the latter, although admitting they are medical devices that should fall under the FD&C Act, because EHRs are a "political hot potato."  See this post for the relevant citations.)

... "This has been excruciatingly painful to do what is needed for those people who need it most," said Dr. Rachel Steinhart, an emergency room doctor who worked a graveyard shift ending Tuesday morning, hours before the board meeting. She said she still had to document paperwork for 16 of her patients. "It's going to implode. It can't go on like this."

Patients are surely going to be injured or killed in this setting.  There is likely a "hold harmless" clause with the vendor, so, doctors, I'm sorry to say, despite your complaints, you will very likely be held legally liable.

The head of the county's health care system sympathizes, and hopes to work with medical staff to ease the transition for what is a monumental moment in medical history.

"We're in an era of massive change right now, not only in our system, but in the system nationwide," said Dr. William Walker, Contra Costa's health services director. "Coming with the rapidity is its throwing people off balance."

Dr. Walker has just painted a big red "name me as a defendant for gross negligence and breach of fiduciary responsibilities to patients and clinicians" target on his back for glossing over known health IT risks and what appear to be rather profound complaints coming from his constituents.  Instead, he supplies platitudes, not action to remediate or withdraw the bad IT.

Name me as a defendant for gross negligence and breach of fiduciary responsibilities to patients and clinicians


The response is stunning:

To ease the burden, Walker hopes to have teams of medical care providers formed to ease the doctors' paperwork burden, enabling them to return to treating patients.

It takes teams of physicians to properly see a patient due to the interference of EHRs?  That is remarkable.

The ccLink program has its benefits, some doctors said. Dr. Chris Farnitano, an ambulatory care medical director, described how he retrieved a patient's biopsy results from a different hospital on the spot, whereas in the past it would have taken weeks.

However, other doctors called ccLink clunky and time-consuming, designed more for bureaucrats than physicians. Even with doctors cutting their patient load in half -- meaning half as many appointments are available for patients -- doctors complained that they spend more time on their computers than treating patients.

This is misdirection by the Medical Director.  It's unarguable that the risks far outweigh the benefits.  Further, retrieving a biopsy or other result result instantaneously could easily be done from an innocuous, non-disruptive document imaging system (e.g., Documentum).  The latter would also be many millions of dollars less expensive than an EHR.

"It's a truncation of patient care. The individual patient doesn't get the care they used to get," said David MacDonald, a 22-year family medicine doctor.

Again, Dr. MacDonald, the liability for adverse outcomes is on you.

You are now, in effectm an indentured servant of an IT company, providing free alpha and beta testing at your expense and peril, using the patients as an even lower level of indentured servant/guinea pig.

There's also significant patient-endangering collateral damage from this mayhem:

The lack of appointments has overburdened emergency rooms, which already exceeded emergency room wait benchmarks in a facility built to see 80 patients a day, but often sees more than 200 patients a day. Since ccLink started, the average patient spends four hours in the ER, up an hour from before the computer system transition, which was already over national benchmarks, said Reilly.

The scenario could not be worse.  The ED's are themselves burdened by EHR's.

The supervisors asked for continued updates, and for patience.

"Continuous improvement means you need continuous change," said supervisor Federal Glover. "Eventually, it's going to become second nature as it was with cell phones. We'll wonder how we ever did without it."

Supervisor Glover has also painted a "defendant" target on his back.  This is the misdirection I was speaking of earlier, consisting of platitudes, logical fallacy and falsehoods:

  • "Continuous improvement" is not what's going on here; 
  • Such improvement does not mean creating chaos as a precondition; 
  • Whether this software will become "second nature" is anyone's guess.  That is a hysterical and logically fallacious statement (e.g., an appeal to belief) of an almost quasi-religious fanaticism regarding computing.  This technology could ultimately be scrapped in favor of, say, simpler document imaging systems due to increasing clinician complaints, inherent usability issues in fast-paced medical settings, litigation, costs, harms etc.;
  • What of the patients placed at risk, and/or injured/killed as a result of this experimentation?  What of them, and their medical and human rights?

In effect, a response like this is medically unethical.  The correct response would be a halt in the rollout until problems are substantially remediated in a controlled, risk free setting - not the clinic.

If that is not possible, the system needs to indeed be scrapped or replaced.

Continuation of patient endangerment is inexcusable medically, ethically and legally.

-- SS

Health Care Academics' Unrest and Bad Health Care Leadership?

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Last month we discussed a recent, large scale study of physician burnout, and wondered whether it would finally inspire some discourse about why physicians are really so upset.  In particular, we hypothesized,  based on some real, if limited data, that physician angst, dissatisfaction, burnout, etc may mainly be a response to the problems with leadership and governance of health care organization we post about on Health Care Renewal.

After that post, one of our scouts found a very interesting and relevant article from earlier this year which got little attention at the time, but deserves more.  [Pololi LH, Krupat E, Civian JT, Ash AS, Brennan RT. Why are a quarter of faculty considering leaving academic medicine? A study of their perceptions of institutional culture and intentions to leave at 26 representative U.S. medical schools. Acad Med. 2012; 87: 859-69. Link here.]

Study Design

This was a cross-sectional survey of faculty at 26 medical schools in the US, selected to be similar to the general population of medical schools in the country.  At each school, 150 faculty were randomly chosen stratified by sex and age, and then the sample was enriched to include additional minority faculty and women surgeons, for a total of 4578.

The faculty were sent a multi item survey to assess their perception of the organizational culture of their institutions, and asked about their intentions to continue in or leave their current positions and academic medicine.  Responses to each survey item were allowed to be from 1 = strongly disagree, to 5 = strongly agree.  The items on the survey were combined into various scales.  A number of items on the survey seemed to be related to issues we frequently discuss on Health Care Renewal.  These items ended up in three different scales, entitled Relatedness/Inclusion, Values Alignment, and Ethical/Moral Distress.  The survey items are listed below, grouped by issue, with the scales into which they were combined noted.

Issue: Mission-Hostile Leadership

Administration only interested in me for revenue   (Reverse coded) (Values Alignment)
Institution committed to serving the public (VA)
Institution's actions well-aligned with stated values and mission (VA)
Institution puts own needs ahead of educational/clinical missions (RC) (VA)
My values well-aligned with school's (VA)
Institution awards excellence in clinical care (VA)
Institution does not value teaching (RC) (VA)
Have to compromise values to work here (Ethical/Moral Distress)

Issue: Deceptive, Unethical Leadership

Felt pressure to behave unethically (Ethical/Moral Distress)
Need to be deceitful in order to succeed (EMD)
Others have taken credit for my work (EMD)

Issue: Generation of the Anechoic Effect by  Suppression of Free Speech, Academic Freedom, Dissent, Whistle-Blowing,

Feel ignored/ invisible (RC) (Relatedness/Inclusion)
Hide what I think and feel (RC) (R/I)
Reluctant to express opinion/ fear negative consequences (RC) (R/I)

So in summary, the survey contained quite a few questions about mission-hostile management, comprising nearly all of the Values Alignment scale, some questions about deceptive or unethical leadership, all in the Ethical/Moral Distress scale, and some about generation of the anechoic effect by suppression of free speech, academic freedom, dissent, and whistle-blowing, all in the Relatedness/Inclusion scale.

Results

The response rate was 52% (N=2381.)

Unfortunately, the article did not include the distributions of the responses to individual survey items, and only included the mean and standard error of the scale scores.  The values for the scales of most interest were:
Relatedness/Inclusion  3.56 SE= 0.022
Values Alignment  3.25 SE=0.028
Ethical/Moral Distress 2.36 SE=0.022

Note that the article did not address the degree individual items, especially those listed above, contributed to variation in the scale scores.


A small majority of faculty indicated their intentions to stay at their institutions (57%).  Of the remainder, 14% were considering leaving their school due to dissatisfaction, and another 21% were considering leaving academic medicine due to dissatisfaction.  The remainder were considering leaving due to personal/ family reasons or to retire.

The authors did complex multinomial logit modeling to assess the relationships among the various scales, demographic factors, and intention to leave.  Most relevant to us, Relatedness/Inclusion was significantly related to intention to leave the institution due to dissatisfaction (Coefficient -0.69, p lt 0.001, OR =0.50), as was Values Alignment (-0.39, p=0.04, OR=0.68), but not Ethical/ Moral Distress.  Furthermore, Relatedness/Inclusion was related to intention to leave academic medicine due to dissatisfaction (-0.48, p lt 0.001, 0.62), as was Ethical/Moral Distress (0.60, p lt 0.001, OR =1.82).The article did not address whether individual survey items, including those of most interest listed above, were related to intention to leave.  The article also did not address whether responses to the survey or intention to leave varied across faculty characteristics, medical school characteristics, or individual medical schools. 

Summary and Comments

This very large survey of faculty from multiple US medical schools showed that more than one-third were considering leaving their institutions or academic medicine due to dissatisfaction, indicating a striking prevalence of faculty distress.  Their responses to questions about perceived organizational cultural and leadership problems, including those possibly related to leadership's perceived hostility to the mission, leadership's perceived dishonesty or unethical behavior, and leadership's suppression of dissent, free speech, academic freedom, and whistle-blowing were related to their intentions to leave due to dissatisfaction.

These results suggest the hypothesis that much of faculty angst may be due to the sorts of problems with leadership and hence organizational culture that we discuss on Health Care Renewal.  Since this was a cross-sectional survey, it certainly does not offer scientific proof of this hypothesis.  Note that there is other evidence from numerous cases discussed in Health Care Renewal, qualitative studies and our much smaller study published only in abstract form that also supports this hypothesis (look here). 

One part of the author's discussion of their findings was particularly relevant:


Our findings are congruent with metaanalyses of 25 years of organizational justice research outside medicine. These studies suggest that employee perceptions of organizational justice and an ethical climate are related to increased job satisfaction, trust in leadership, enhanced performance, commitment to one’s employer, and reduced turnover.

 The scale of ethical/moral distress (see Table 1) reflects reactions to the prevailing norms and possible erosion of professionalism and increased organizational self-interest. There is a growing belief that organizations influence and are responsible for the ethical or unethical behaviors of their employees.To our knowledge, faculty perceptions of 'moral atmosphere' and 'just community' embedded in our survey have not been previously investigated in academic medicine, even though the ethical concepts of professionalism and justice can be used to guide the pursuit of excellence in the missions of medical schools. Several scholars have called for academic medicine to attend to its social justice and moral mission. Faculty perceptions
of organizational justice are pivotal to the critical issue of professionalism in medicine. The ethical/moral distress scale in the survey reported here included items such as 'the culture of my institution discourages altruism' and 'I find working here to be dehumanizing.' (See Table 1 for other items in this scale.) In that ethical/moral distress was more strongly related to intent to leave academic medicine entirely than intent to leave one’s own institution, these negative feelings among faculty must be particularly disheartening to them and may color major career decisions.
I believe that the study by Pololi et al adds to the evidence that physician distress is a symptom of a dysfunctional system in which major health care organizations have been taken over by leaders more devoted to self-interest and short-term revenue than the values prized by health care professionals and academics.  This applies obviously to academic medical institutions, but also to other organizations that might have been expected to defend such professional and academic values, such as professional associations, accrediting organizations, and health care foundations.  As we said before, if physicians really want to address what is making them burned out and dissatisfied, they will have to regain control of their own societies, organizations, and academic institutions, and ensure that these organizations put core values, not revenue generation and providing  cushy compensation to their executives, first.  

Don't Cry for Me, Brazil - UnitedHealth May Buy Brazilian Managed Care Company

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While Health Care Renewal's bloggers are at the moment all Americans, and hence tend to focus on the wild and crazy US health care system, we have suggested that many of the issues we discuss have global implications.  In fact, the first article I managed to publish on health care dysfunction was in a European journal, and framed the US experience as a cautionary tale for other countries. [Poses MD. A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14: 123-130.  Link here.]

The Possible Acquisition by UnitedHealth of Brazil's Leading Managed Care Company

However, sometimes it appears that the US experience might be directly exported.  Today Bloomberg reported,

UnitedHealth Group Inc., the biggest U.S. health insurance company, is in talks to buy a stake or all of the Brazilian insurer and hospital operator Amil Participacoes SA, according to people familiar with the matter.
Acquiring all or part of Brazil’s biggest managed-care company, which carries a market value of 9.01 billion reais ($4.47 billion), would give Minnetonka, Minnesota-based UnitedHealth access to a growing private-insurance market in the world’s second-biggest emerging economy. It also may generate more opportunities for UnitedHealth’s Optum unit, which provides technology and consulting to health systems in India, China, the U.K. and elsewhere.
UnitedHealth's Ethical Record

UnitedHealth would be the company whose CEO once was worth over a billion dollars due to back dated stock options, some of which he had to give back, but despite all the resulting legal actions, was still the ninth best paid CEO in the US for the first decade of the 21st century (look here). UnitedHealth would be the company whose current CEO made a cool $106 million in 2009 (look here).

Moreover, UnitedHealth would also be the company known for a string of ethical lapses:
- as reported by the Hartford Courant, "UnitedHealth Group Inc., the largest U.S. health insurer, will refund $50 million to small businesses that New York state officials said were overcharged in 2006."
- UnitedHalth promised its investors it would continue to raise premiums, even if that priced increasing numbers of people out of its policies (see post here);
- UnitedHealth's acquisition of Pacificare in California allegedly lead to a "meltdown" of its claims paying mechanisms (see post here);
- UnitedHealth's acquisition of Sierra Health Services allegedly gave it a monopoly in Utah, while the company allegedly was transferring much of its revenue out of the state of Rhode Island, rather than using it to pay claims (see post here)
- UnitedHealth frequently violated Nebraska insurance laws (see post here);
- UnitedHealth settled charges that its Ingenix subsidiaries manipulation of data lead to underpaying patients who received out-of-network care (see post here).
- UnitedHealth was accused of hiding the fact that the physicians it is now employing through its Optum subsidiary in fact work for a for-profit company, not directly for their patients (see post here).

Exporting Health Care Dysfunction

So while the deal discussed above might be good for UnitedHealth, it is not so clear that it would be good for Brazil, as it would give a big toe-hold in Brazil to a US company whose actions have not always been exemplary, and hence may give Brazil a whiff of US health care dysfunction.


Health care dysfunction in the US has been manifested by continuously rising costs while access and quality have been threatened.  While it is possible that our recent Affordable Care Act reforms will improve access, and perhaps quality, it is likely the country will continue to lag other developed countries in providing health care value (for examples, look at this Commonwealth Fund site including international comparisons.) 

Moreover, health care dysfunction may have resulted in a uniquely distressed physician population in the US compared to those in other countries.  Here we discussed a recent large-scale survey showing nearly half of all US physicians, and more than half of generalist physicians are burned-out.  Here we discussed another recent large-scale survey showing that more than a third of US academic physicians want to quit their institution and/or academia. That survey may have suggested that their dissatisfaction was due to concerns that their leaders did not share their values about patient care and academics, their leaders may put revenue ahead of these values, their leaders may have suppressed dissent, free speech, academic freedom, and whistle-blowing, and their leaders may have acquiesced to a culture of dishonesty and deceit.

 On Health Care Renewal, we have postulated that our unique mix of health care misery may be due to a witch's brew of  concentration and abuse of power in health care, bad (that is, ill-informed, incompetent, mission-hostile, self-interested, conflicted or corrupt) leadership of health care, tactics used by bad health care leadership such as use of perverse incentives, creation of conflicts of interest, deception, disinformation, propaganda, intimidation, etc

Thus we would not recommend that other countries look to our health care system as a role model, and that their citizens should be very skeptical of US health care organizations, particularly large, for-profit health care corporations with spotty ethical records, when they come calling. Meanwhile, we in the US must do a better job solving our own health care problems, and should avoid trying to export them.

New York Times: "The Ups and Downs of Electronic Medical Records"

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The "downs" of health IT have rarely been presented in a prominent public forum.

After a recent Center for Public Integrity series and New York Times story on EHR-related upcoding, the New York times does so again.  This blog is cited:

October 8, 2012
The Ups and Downs of Electronic Medical Records

New York Times
By MILT FREUDENHEIM


The case for electronic medical records is compelling: They can make health care more efficient and less expensive, and improve the quality of care by making patients’ medical history easily accessible to all who treat them.

Small wonder that the idea has been promoted by the Obama administration, with strong bipartisan and industry support. The government has given $6.5 billion in incentives, and hospitals and doctors have spent billions more.

But as health care providers adopt electronic records, the challenges have proved daunting, with a potential for mix-ups and confusion that can be frustrating, costly and even dangerous. 

"Dangerous" is the concept that has been most lacking in public debate.  Through my many years of writing on health IT difficulties and more recently my legal work, I know of injuries and deaths caused or contributed to by bad health IT (e.g., see here and here).  I experienced a tragedy in my own family as well.

The New York Times has done a significant public service in mentioning this critical issue, long hushed by the hyper-enthusiasts to whom computers seem to hold more rights than people, and to whom plans for a "cybernetic healthcare utopia" override long held principles and standards for human subject research protections.

Some doctors complain that the electronic systems are clunky and time-consuming, designed more for bureaucrats than physicians. Last month, for example, the public health system in Contra Costa County in California slowed to a crawl under a new information-technology system. 
Doctors told county supervisors they were able to see only half as many patients as usual as they struggled with the unfamiliar screens and clicks. Nurses had similar concerns. At the county jail, they said, a mistaken order for a high dose of a dangerous heart medicine was caught just in time. 

That scenario, not at all unique (e.g., see New York Times, "Designed for Efficiency, New Computer Software at Health Dept. Misfires", Nov. 2010 and my comments here), is a warning that the technology needs significant work and cannot just be rammed into place.
The first national coordinator for health information technology, Dr. David J. Brailer, was appointed in 2004, by President George W. Bush. Dr. Brailer encouraged the beginnings of the switch from paper charts to computers. But in an interview last month, he said: “The current information tools are still difficult to set up. They are hard to use. They fit only parts of what doctors do, and not the rest.”

Refreshing candor that should be coming from the present ONC leader, not the two-generations-ago former incumbent.

Like all computerized systems, electronic records are vulnerable to crashes. Parts of the system at the University of Pittsburgh Medical Center were down recently for six hours over two days; the hospital had an alternate database that kept patients’ histories available until the problem was fixed. 

Those crashes are also not uncommon.  See for instance my posts on the common refrain when that happens that "patient care has not been compromised" (query link).
Even the internationally respected Mayo Clinic, which treats more than a million patients a year, has serious unresolved problems after working for years to get its three major electronic records systems to talk to one another. Dr. Dawn S. Milliner, the chief medical informatics officer at Mayo, said her people were “working actively on a number of fronts” to make the systems “interoperable” but acknowledged, “We have not solved that yet.”

Perhaps the worst example of that phenomenon is the DoD-VA interface debacle.  See my apparently popular (based on "hits") March 2010 post "VA / DoD EHR Interface Debacle: Will It Take the Luminosity Of A Dozen Supernovas To Shed Light On The Obvious About Healthcare IT?"

Still, Dr. Milliner added that even though there a lot of challenges, the benefits of information technology are “enormous” — improved safety and quality of care, convenience for patients and better outcomes in general.

Enormous?  It is quite clear that this has not been proven in the real world with large scale health IT, especially in its present form.  It may be the case that the improvements will be modest at best.  Many if not most healthcare problems may not be related to documentation at all (see my Dec. 2010 post "Is Healthcare IT a Solution to the Wrong Problem?" for instance).  Also, as I've written, a good or even fair paper record system is better for patients than BHIT (bad health IT).

In the rare event that a large-scale system goes down at Mayo, backup measures are ready, teams are called in to make rapid repairs, and if necessary “everyone is ready to go on paper,” Dr. Milliner said. 

Paper records do not unexpectedly "go down" en masse.

Reliable data about problems in the electronic systems is hard to come by, hidden by a virtual code of silence enforced by fears of lawsuits and bad publicity. A recent study commissioned by the government sketches the magnitude of the problem, calling for tools to report problems and to prevent them. 

"Omertà" is perhaps the best term of art for this form of silence...
Based on error rates in other industries, the report estimates that if and when electronic health records are fully adopted, they could be linked to at least 60,000 adverse events a year.

My own estimates are much higher if the technology and its industry are not first drastically reformed, as in my April 2010 post "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers."

The Obama administration will issue a report on patient safety issues in early November, the current national coordinator, Dr. Farzad Mostashari, said in an interview. That report was requested last year by a panel on health I.T. safety at the Institute of Medicine, a unit of the National Academies of Science.

Considering the available data is limited, as per the FDA and IOM itself (see addendum here), the report should be immediately suspect for underestimation/cheerleading if not whitewashing.

... Elisabeth Belmont, a lawyer for the MaineHealth system, based in Portland, advises hospitals to reject contract language that could leave them responsible for settling claims for patient injuries caused by software problems.

The IT industry is quite mature and no longer merits such special accommodation.  As in other industries, liability should be covered by the industry itself, not by customers (and patient victims).  See "No More Soft Landings for Software: Liability for Defects in an Industry That Has Come of Age", Frances E. Zollers, Andrew McMullin, Sandra N. Hurd, and Peter Shears, Santa Clara Computer & High Technology Law Journal, May 2005.

The institute also recommended that software manufacturers be required to report deaths, serious injuries or unsafe conditions related to information technology. So far, however, neither a new safety agency nor such a reporting system has been adopted.  Some of the largest software companies have opposed any mandatory reporting requirement.

Post market surveillance is standard for other medical device sectors and the pharma industry, as well as other mission critical IT sectors.  The continuing, remarkable special accommodation for health IT is unearned, unjustified and ethically inexplicable.

Critics are deeply skeptical that electronic records are ready for prime time. “The technology is being pushed, with no good scientific basis,” said Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog Health Care Renewal. He says testing these systems on patients without their consent “raises ethical questions.” 
In other words, while I am an advocate for good health IT, the technology is not yet ready to be pushed nationally.  Bad health IT prevails.  From my Medical Informatics teaching site:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

(I would replace the term "critic" with "realist" and/or "patient rights advocate.")

Another critic, Dr. Scott A. Monteith [who has guest-posted at this blog - ed.], a psychiatrist and health I.T. consultant in Michigan, notes that Medicare and insurance companies generally do not pay for experimental treatments that have not proved their effectiveness ... Dr. Monteith said the electronic systems were “disrupting traditional medical records and, beyond that, how we think” — the process of arriving at a diagnosis. For example, the diagnosing process can include “looking at six pieces of paper,” he said. “We cannot do that on a monitor. It really affects how we think.”

The systems are disruptive due to the paradigm changes, made far worse by their also often being mission hostile in design.

“The problem is each patient is an individual,” said Ms. Burger, who is president of the California Nurses Association. “We need the ability to change that care plan, based on age and sex and other factors.” She acknowledged that the system had one advantage: overcoming the ancient problem of bad handwriting. “It makes it easier for me to read progress notes that physicians have written, and vice versa,” she said.

While this is true, it is also true that the loss of context and structure produces legible gibberish that does not relate the patient narrative well.  Also, the same legibility improvement could be obtained via word processors - or typewriters - that cost far less than the tens of millions of dollars or more per organization that clinical IT commonly costs.

Some experts said they were hopeful that the initial problems with electronic records would be settled over time.

I'm one of them.  Without major health IT industry reforms, however, including strict adherence to evidence-based practices (as that selfsame industry sector demands of medicine and ironically and hypocritically claims its products will enable), I don't expect to see the problems settled in my lifetime.

Dr. Brailer, who now heads Health Evolution Partners, a venture capital firm in San Francisco, said that “most of the clunky first-generation tools” would be replaced in 10 years. “As the industry continues to grind forward, costs will go down,” he said. 

One should ask - why are 'first generation' tools still in abundance, decades into the healthcare information technology industry?  Further, as the industry "grinds forward" without oversight and patient protections, people will be injured.

Mark V. Pauly, professor of health care management at the Wharton School, said the health I.T. industry was moving in the right direction but that it had a long way to go before it would save real money.  “Like so many other things in health care,” Dr. Pauly said, “the amount of accomplishment is well short of the amount of cheerleading.”

That is an understatement.

(Not covered in this article perhaps due to limited space are the issues of information security, privacy and confidentiality that are compromised by current clinical IT.)

In conclusion, it is good that the New York Times has brought the downsides into the public eye.  While the technology's not "ready for prime time", a story like this is ready for prime time, and is in fact long overdue:

-- SS

The Rise of the Corporate Physician, and the "Metastasis of Big Corporations"

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Public discussion has raised more questions over the last few months about physicians taking care of patients as corporate employees. 

More Physician Practices Taken over by Large Corporations

This year, more stories have appeared about large corporations taking over physician practices.  In February, there was an account of efforts by competing nominally non-profit health insurance company Highmark and nominally non-profit hospital system UPMC in Pittsburgh in a "race to gobble up private physician practices," per the Pittsburgh Tribune-Review.  In March, the Washington Post featured a first-person account of what it is like for a physician in a private practice to try to hold out against the trend towards corporate practice.  In May, the Los Angeles Times noted how for-profit dialysis provider Da Vita purchased a large, but already for-profit operator of physician groups.  In October, Reuters reported how the recently announced acquisition by giant for-profit insurance company UnitedHealth of the biggest Brazilian for-profit managed care company will result in UnitedHealth owning an operating a Brazilian network of hospitals and clinics.

Concerns about Concentration of Market Power and Prices

In an increasingly financialized country, the media has featured concerns that the trend towards corporate physician practice might result in increasing market power for a few large corporations, and hence increased prices.  For example, in August, Anna Wilde Matthews reporting for the Wall Street Journal, noted
 Hospitals say the acquisitions will make health care more efficient. But the phenomenon, in some cases, also is having another effect: higher prices. 

As physicians are subsumed into hospital systems, they can get paid for services at the systems' rates, which are typically more generous than what insurers pay independent doctors. What's more, some services that physicians previously performed at independent facilities, such as imaging scans, may start to be billed as hospital outpatient procedures, sometimes more than doubling the cost.
 
The result is that the same service, even sometimes provided in the same location, can cost more once a practice signs on with a hospital.

Major health insurers say a growing number of rate increases are tied to physician-practice acquisitions. 

As Ms Matthews also reported for the Wall Street Journal, state regulators are beginning to worry about acquisitions of doctors' practices by hospital systems may drive up prices.
California's attorney general has launched a broad investigation into whether growing consolidation among hospitals and doctor groups is pushing up the price of medical care, reflecting increasing scrutiny by antitrust regulators of medical-provider deals.
Concerns about Care Quality

Concerns about whether physicians who must practice under the command of corporate executives will be able to put patient care ahead of corporate interests are also appearing, but not yet as prominently.

For example, Steve Twedt, writing for the Pittsburg Post-Gazette in September, looked into whether the multiple practice acquisitions by the area's two biggest ostensibly non-profit health care corporations might affect patient care.  He first noted "competition between Highmark and UPMC for doctors, and health care overhaul that is steering doctors into larger systems...."  Then he suggested that this has lead to marked discontinuities in patient care when physicians switch employment,
Out of the blue, people will learn their doctor has left a practice with little or no explanation, and without a forwarding address. When a physician effectively disappears, the cause usually is tied to the physician's employment contract, says a local health care attorney.
These cases of apparently vanishing physicians may be due to the contracting practices of physician employers, particularly large health care corporations.  The lawyer Mr Twedt interviewed explained,
most physician contracts now contain clauses that prohibit doctors from soliciting patients if they leave a practice.

While it's not always clear what constitutes 'solicitation,' it generally means departing physicians cannot contact their patients to invite or entice patients to follow them to their new location. They also cannot take their patient list with them, since that is property of the practice.

'I would imagine the doctor wouldn't contact them because he can't, or he doesn't have their address,' said Mr. Cassidy.

Contracts also often require that doctors cannot practice medicine within 10 miles of the previous practice office, and sometimes the required distance is even greater. Nor can they give out information about the practice they're leaving. Violating these contract terms could mean a financial penalty, such as loss of severance pay.
Finally, and most troubling, cardiologist blogger Dr Melissa Walton-Shirley recounted in some much more colorful language some consequences of cardiology practices which were acquired by large hospital systems.  She noted... Referral Decisions Influenced by Management Edicts, but Maybe Not Patients' Needs Physicians may be
sweating bullets over whether they are going to hit their benchmarks to retain their salaries. My anxious friends are now calling me for more referrals and more practice support.  They take any transfer I give them....
They may
 morph from human flesh into a Rubik's cube of relative value units (RVUs), the formula through which all future salaries and bonuses are calculated.

Resulting Loss of Continuity
Independent cardiologists opened office doors to find their patients who were anticipating decisions on timing of defibrillators, caths, or medical therapy had undergone testing at other facilities. Those tests were interpreted by cardiologists who were in no way connected to their care, their referrals to unfamiliar testing venues now incentivized by hidden contractual microformulas. They were evaluated far away from the familiar eye of their long-time cardiologists.


Summary

Back in the day, most physicians who took direct care of patients did so out of practices they or other physicians ran and owned.  The majority of physicians who took care of physicians as employees worked for the military or the Veterans Administration, or took care of patients only part-time as faculty of medical schools.  In a country increasingly prodded by market fundamentalism, the last few years has seen a major change in health care:  more and more physicians are taking care of patients as employees of large corporations, more often for-profit.

 I should add, though, that the recent push towards corporate practice was not just due to market fundamentalism, but also seems to in part be due to provisions of the recent attempt at US health care reform, the Affordable Care Act, which called for care by large organizations called accountable care organizations (ACOs).   However, like some other major changes in health care in the US over the last few years pushed by the increasing dominance of large corporations, this one happened without any rigorous assessments of whether the benefits for individual patients or public health would outweigh the harms, and justify the costs. 

Justified by the realization, now mostly forgotten, that health care is nothing like an ideal free market (look here), direct health care used to be almost entirely provided by health care professionals, often working in small, non-profit community hospital settings.  In fact, the American Medical Association used to condemn the corporate practice of medicine.  In addition, the corporate practice of medicine used to be illegal in many US states (look here).

We have changed all that, without too much thought, and without any rigorous assessment.  Now it seems increasingly likely that these changes are just increasing health care costs, and probably will cause worsening patient care and will worsen patients' and the public's health. 

As Dr Melissa Walton-Shirley wrote more vividly,
Monopolies never meant to be planted in gardens so small grew like bull thistles, literally overtaking all the good things that small community medicine had to offer. They are now barely recognizable small towns with the crabgrasslike metastasis of big corporations....

Will there be time to rethink this headlong rush before our health care options are restricted to that provided by one of a few huge corporations?  

True health care reform would reverse the trend to organize health care within ever larger, more bureaucratic, more monolithic, more dominant organizations.  Such reform is unlikely to happen until we see the nadir produced by the current bandwagon. 

9 Ekim 2012 Salı

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