Addressing threats to health care's core values, especially those stemming from concentration and abuse of power - and now larger threats to the democracy needed to advance health and welfare. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.
We now see reports of how the US is short of either masks, gowns, doctors, hospital beds, ventilators, community health workers, tests, treatments, or some combination thereof, to manage the new COVID pandemic and the annual influenza season. We see Congress hustling to adopt a funding package to catch up with the gaps.
I just saw, as an attending physician on a busy urban internal medicine hospital service, how that shortage potentially endangered mine and my colleagues lives, as well as that of my patients. At first we were told to reuse our masks--there might be or would soon be a shortage. Then we were told NOT UNDER ANY CIRCUMSTANCE to reuse them--we could infect patients by room-to-room transmission. Then we ran short of masks and.....well you can guess what we were told.
All this got me to thinking about a project I was involved in nearly 15 years ago. I was part of a national task force asked to develop a national public health and primary care response plan to respond to a theoretical (then presumed influenza) pandemic in the US. We did, over a year-long series of scholarly and cordial meetings and document exchanges. All the primary care disciplines lent representatives to the committee, organized by the Agency for Healthcare Research and Quality (then AHCPR).
As far as I can tell, our report, which would have required a significant cost outlay for workers and equipment which would sit idle until the pandemic arrived, was not adopted, and no funds were approved to beef up the already anemic public health infrastructure at that time, just post 911. Even 911 was not enough to boost a response that, I suspect, national leaders saw as wasteful.
Wasteful... hmm. That means pockets would be emptier, balance sheets more toward the red, taxes higher, and stockholders' value down. We needed to operate more like a business, cut waste, and increase efficiency.
But wait, that's managerialism right? Increase shareholder value at all costs, even, in this case, human lives. We've got a business--I mean public health infrastructure to run here. No time for more idle firemen.
I wonder if anybody in power around 15 years ago remembers sitting on our plan, and regrets not adopting it? This year, almost 60,000 have died from influenza, and we are waiting to see the death toll from COVID. How much money is a life worth?
The AHRQ
National Guideline Clearinghouse (NGC, guideline.gov) Web site will not
be available after July 16, 2018 because federal funding through AHRQ
will no longer be available to support the NGC as of that date. AHRQ is
receiving expressions of interest from stakeholders interested in
carrying on NGC's work. It is not clear at this time, however, when or
if NGC (or something like NGC) will be online again. In addition, AHRQ
has not yet determined whether, or to what extent, the Agency would have
an ongoing role if a stakeholder were to continue to operate the NGC.
We will continue to post summaries of new and updated evidence-based
clinical practice guidelines until July 2, 2018. For any questions,
please contact Mary.Nix@ahrq.hhs.gov.
We went on to summarize the importance of this clearinghouse as a reasonably comprehensive source of material about the myriad clinical practice guidelines that have been promulgated ostensibly to improve medical care. Its importance was recently enhanced by the addition of ratings of the trustworthiness of particular guidelines derived from standards developed by the US Institute of Medicine (look here). In turn, these standards were necessary because many published guidelines were afflicted with methodologic problems. Some amounted to little more than informal recommendations of experts. Many guidelines were suspected of being influenced by commercial sponsors or by the financial relationships of the people involved in developing them. Pharmaceutical, biotechnology, device and other firms that market health care goods and services have long been interested in meddling in guideline development to assure that guidelines put their products and services in a favorable light.
We concluded
Now we will lose an important resource for teaching, research, and
evidence-based practice, whose loss will make it easier to hucksters to
promote drugs, devices, and programs that are not as efficacious or safe
as advertised. But the good times will continue to
roll.
We could call for the reinstatement of the AHRQ National Guideline
Clearinghouse. Ah, but we may as well try and catch the wind.
Again, note that as of June 1, 2018, nothing about the shutdown of the clearinghouse had appeared in the media, or in medical or health care scholarly journals. We hoped maybe the post in our humble blog would start some discussion.
Further Media Coverage
At the time, despite our hopes, experience suggested nothing much would happen. This time, however, we were wrong.
Diagnostic and treatment guidelines aren’t sexy, but they play a vital role in the practice of medicine.
Oransky and Marcus found that the NGC was actually fairly heavily used, drawing 200,000 visitors a month. After further summarizing the issue, they noted the ambiguous official justification for the closure of the clearinghouse.
'The decision to end support for the NGC was an Agency decision based on assessing how best to use our current resources, including both appropriated dollars and dollars from the Patient-Centered Outcomes Research Trust Fund,' the AHRQ spokesperson told STAT. The AHRQ budget for the 2019 fiscal year, as proposed by the Trump administration, 'will re-focus support to only the highest priority research programs.'
They also excerpted our conclusions above, and lamented,
With the date of death for the NGG barely a month away, America’s doctors — and their patients — may, to paraphrase another clearinghouse, already be losers.
medical research like that maintained by the NGC can be politicized, [so] AHRQ drew the ire of then-congressmember Tom Price in 2016 when it published a study critical of a drug manufactured by one of his campaign donors. According to ProPublica, one of Price’s aides emailed 'at least half a dozen times' asking the agency to pull the critical research down. Price was the first director of HHS, AHRQ’s parent agency, under the Trump Administration, before resigning under pressure last year over his spending on chartered flights.
Note that we had discussed then Representative Price's intervention here.
Campbell interviewed several people, including your humble scribe, about the meaning of the AHRQ's actions, and concluded with
'Losing [the NGC] is really losing a valuable resource,' said Ana Maria Lopez, President of the American College of Physicians. She said the NGC is a primary source for her organization’s research, and noted that digital repositories like the NGC are only more critical today.
Other Coverage
Since then, Vox and CNN have covered the issue on July 16, the day of the planned shutdown. The surge of concern about the topic did not apparently prevent it from happening, however.
The official explanation is maddening enough: a budget shortfall that roughly equals the amount Tom Price spent on travel during his brief tenure as department secretary. The site costs just $1.2 million a year to operate, and is maintained by an agency with a budget of more than $300 million.
It concluded hopefully with:
A better solution would almost certainly be for Congress to appropriate the money needed to keep the database up and running. It could do that simply by renewing the Affordable Care Act fund that was covering the database’s operating costs, and that is scheduled to expire in 2019.
Of course, Congress will take that action only if constituents demand it. But in a country that has voted representatives in and out of office based on their health care policies, and that prides itself on drawing attention to intractable diseases (we dump ice buckets on our heads to raise funds to fight A.L.S., and walk countless miles for breast cancer), evidence-based medicine should be an easy sell.
I am not holding my breath. However, I never thought this issue, perhaps a small on given the huge political dysfunction that grips the country, would make it much farther than my blog post of June 1. So we can hope.
Furthermore, there has been movement towards preserving some of the clearinghouse's functions. As discussed in Modern Healthcare on July 17, 2018, the ECRI Instsitute plans to resurrect the site. It would no longer be free, but will be based on a subscription model which ECRI hopes will keep the costs reasonable. So at least that is real progress since June 1.
Discussion
Many people bemoan the current political situation, but some feel there is nothing they could possibly do the improve things. We have been publishing this blog since 2004 with the hopes that chipping away at the anechoic effect which has hid the severity and nature of health care dysfunction might actually help to improve things. However, at times we wondered if we were having any effect. What good are individual actions like blog posts?
It seems that most of us have little individual power. Collectively, though we may have more than we realize. Small individual actions can add up. I hope the at least partial resurrection of the National Clinical Guidelines Clearinghouse will provide an example that will inspire further individual actions to address health care dysfunction, and the much larger political and economic dysfunction that generate it, and that now threatens us all.
The AHRQ National Guideline Clearinghouse (NGC, guideline.gov) Web site will not be available after July 16, 2018 because federal funding through AHRQ will no longer be available to support the NGC as of that date. AHRQ is receiving expressions of interest from stakeholders interested in carrying on NGC's work. It is not clear at this time, however, when or if NGC (or something like NGC) will be online again. In addition, AHRQ has not yet determined whether, or to what extent, the Agency would have an ongoing role if a stakeholder were to continue to operate the NGC. We will continue to post summaries of new and updated evidence-based clinical practice guidelines until July 2, 2018. For any questions, please contact Mary.Nix@ahrq.hhs.gov.
The Importance of the National Guideline Clearinghouse
The shutdown is significant because the Clearinghouse was an important source of information on diverse practice guidelines useful to clinicians, but also to medical and health care educators and researchers.
It is noteworthy that AHRQ has recently endeavored to assure the trustworthiness of the posted guidelines. While guidelines have been long and widely touted as a way to improve the quality of health care, there have been continuing questions about their validity and usefulness. In particular, there was accumulating evidence that many available guidelines were biased by
conflicts of interest, based on an incomplete sample of available
evidence, and were not necessarily informed by rigorous review of the
available evidence, as we discussed here.
In response, in 2011, the US Institute of Medicine (IOM) published standards for trustworthy guidelines (look here). These standards were more rigorous and better justified than any prevous attempts to assure guideline quality.
Most guidelines used today suffer from shortcomings in
development. Dubious trust in guidelines is the result of many factors,
including failure to represent a variety of disciplines in guideline
development groups, lack of transparency in how recommendations are derived and rated, and omission of a thorough external review process. To be trustworthy, clinical practice guidelines should:
• Be based on a systematic review of the existing evidence;
• Be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups;
• Consider important patient subgroups and patient preferences, as appropriate;
• Be based on an explicit and transparent process that minimizes distortions, biases, and conflicts of interest;
• Provide a clear explanation of the logical relationships between
alternative care options and health outcomes, and provide ratings of
both the quality of evidence and the strength of recommendations; and
• Be reconsidered and revised as appropriate when important new evidence warrants modifications of recommendations.
Additionally, as reflected in the committee’s standards for developing trustworthy clinical practice guidelines, guideline development groups optimally comprise members without conflict of interest. The
committee recognizes that in some circumstances, a guideline
development group may not be able to perform its work without members
who have conflicts of interest—for example, relevant clinical
specialists who receive a substantial portion of their incomes from
services pertinent to the guideline. Therefore, the committee specifies
that members of the guideline development group who have a conflict of
interest should not represent more than a minority of the group.
However reasonable these standards may have appeared, by 2012 the IOM standards were largely ignored (as discussed here).
Yet, in 2017, at least one study appeared suggesting that many guidelines in the Clearinghouse did not meet the IOM standards (look here). That year the AHRQ proclaimed that it would start assessing guidelines' adherence to the IOM standards (look here).
This is noteworthy again considering that the standards have had otherwise unfortunately little impact.
And now it seems the AHRQ's worthwhile effort to disseminate guidelines whose trustworthiness can be assessed will end.
Discussion
So it seems that the report on clinical practice guidelines emphasized
two issues highly relevant to Health Care Renewal, the need for transparency in guideline development, and the need to avoid conflicts of interest affecting the development process.
Perhaps more because than despite that, as we noted above, by 2012 the IOM standards were largely ignored (as discussed here). We speculated that these standards may have discomfited many people. They could have cost a lot
of medical societies considerable commercial funding, and a lot of health care professionals on guideline panels considerable
personal wealth. These standards could probably also have cost a lot
of companies whose products and services were addressed by guidelines to
lose revenue. Their implementation could have cost too many people who are
financially benefiting from the status quo too much money. And these
people, that is, leaders of professional societies dependent on
commercial outside funding, health care professionals and academic used
to financial support from commercial interests, and health care
corporations are good at making sure their interests are not ignored,
even if their interests conflict with those of patients, the public, and
well-intentioned health care professionals.
The Trump regime has exhibited great coziness with those who lead large corporations, including health care corporations, and other such plutocrats (look here). The Trump regime appointed a person who was a manager of commercial information technology firms, not a health care professional or researcher, as head of the AHRQ (look here). So it should come as no surprise that the AHRQ leadership under that regime was unable to maintain a Guideline Clearinghouse that attempted to uphold such standards of guideline trustworthiness.
Now we will lose an important resource for teaching, research, and
evidence-based practice, whose loss will make it easier to hucksters to
promote drugs, devices, and programs that are not as efficacious or safe
as advertised. But the good times will continue to
roll.
We could call for the reinstatement of the AHRQ National Guideline Clearinghouse. Ah, but we may as well try and catch the wind.
We have been writing about health care dysfunction since 2003, and
publishing this blog since 2004. A major concern all along has been how
threats to health care professionals' core values generate health care
dysfunction. Up through 2016, these threats came principally from
large private health care organizations. While the US government was
not always as good at defending these values as it could have been, at
least it rarely presented its own set of active threats. Under Trump,
that situation has been changing for the worse. This is obviously
hugely dangerous, (and made more so by the regime's threats to other
core values of US society, to US law, and the US Constitution.)
To prevent the decline and fall of US health care, and maybe the entire
US experiment in representative democracy, health care professionals,
academics, patients and citizens concerned about health care will have
to join up with the larger populace to defend our core values while they
still have any force.
Musical Interlude - Donovan, Try and Catch the Wind, 1973
The Agency for Healthcare Research and Quality (AHRQ) is a US government agency, part of the Department of Health and Human Services (DHHS), whose mission is to
produce evidence to make health care safer, higher quality, more
accessible, equitable, and affordable, and to work within the U.S.
Department of Health and Human Services and with other partners to make
sure that the evidence is understood and used.
It is known for providing grants for sophisticated clinical and health services research, some that uses complex statistical methods, often informed by the the precepts of evidence-based medicine and medical decision making. It also provides resources for related professional education, and has worked to improve both professional and patient understanding of such evidence to inform health care decision making. (Disclosure: I have served on two study sections, that is, grant review committees, for AHRQ, and reviewed numerous additional grants on an ad hoc basis.)
Unfortunately, AHRQ has historically had a very small budget for a federal health care research agency with potentially such wide-ranging scope of interest. As discussed, for example, by Gail Wilensky in 2015, in 1995 the agency aroused the ire of some politically powerful back surgeons for questioning the value to patients of some of the procedures they advocated. Of course, if one actively tries to study "safety, quality, and efficiency of delivering health care in different
health care settings, as well as on the use of health information
technology in achieving these goals," one may produce results that offend certain practitioners, health care provider organizers, or health care corporations. So the agency has been under constant legislative threat of budget reductions or even closure.
Despite that, IMHO, the agency has managed to attract scientifically knowledgeable and dedicated staff, and has had a string of renowned directors, most recently Dr Andrew Bindman, and previously Prof Richard Kronick, Dr Carolyn Clancy, and Dr John Eisenberg, three very distinguished academic physicians and one equally distinguished academic health services researcher.
That was then.... Yesterday, rather abruptly a story appeared in Modern Healthcare about the Trump regime's new appointment to lead the AHRQ, Mr Gopal Khanna. His background was described thus:
Khanna was most recently director since June 2015 of the Illinois Healthcare and Human Services Innovation Incubator, an initiative spearheaded by Gov. Bruce Rauner, a Republican. In that role, Khanna collaborated with other state and federal health agencies to aggregate patient data to better understand the population and efficiency of care.
Prior to that, Khanna was the state of Minnesota's first chief information officer. He also held various positions within George W. Bush's administration.
His official bio which suddenly appeared on the AHRQ website stated he
specializes in data-driven strategies to improve organizational performance.
Also, in his most recent job, he
led a cross-functional team to build a secure data pool with data from
Illinois' HHS agencies and other government entities to provide a
360-degree view of each person and family who receives State services to
provide efficient program management, strategic policymaking, and
customer-centric services delivery.
While he may have worked recently with patient data, I cannot find any evidence that his knowledge of that data went beyond how to handle it within IT systems. Note that his official Agency for Healthcare Research and Quality bio says nothing about health care, health care research, or health care quality per se.
In a 2009 Interview by IT World, Mr Khanna described a long career in information technology, including positions with the National Council on Compensation Insurance, the American Hardware Insurance Group, and International Technology Consultants. He served in President George W Bush's administration as CIO/ CFO of the Peace Corps, and then of the Office of Administration. His highest academic degree appears to be an MBA.
I must admit he seems to be a hard working gentleman who has had recent dedication to public service.
That said, I cannot find any evidence that he has any knowledge or training in health care, health care/ health services research, or health care quality. I cannot find any evidence that he has any previous knowledge about any aspect of the health care research and quality that AHRQ is supposed to foster.
However nice and dedicated he may be, it borders on insulting to those of us who have labored to promote high quality health care/ health services research to promote safe, effective, accessible, affordable health care for him to be the successor to Doctors Bindman, Clancy, Eisenberg, and Professor Kronick. He appears no more qualified to run the AHRQ than I do to captain an aircraft carrier.
Is this some sardonic joke by the ultimate perpetrators of managerialism, the notion that every human organization ought to be run by and ultimately for the the benefit of professional "managers" who know nothing about the goals and values of particular organizations?
The AHRQ is only one small, but I would argue important and high-quality piece of the US health care puzzle. This appointment by the Trump regime is only one small appointment in the midst of much bigger and more more controversial, or outrageous appointments, and terminations. However, it is in wheel house, and I do believe I can add this to evidence that at best, Trump health care policy appears to be mired in confusion, and at worst, risks the destruction of US health care.
While I have no evidence as to any role of EHRs in this seemingly
strange, cavalier and incomprehensible medical decision to send this man
home, resulting in potential exposure of numerous other individuals to
Ebola (and I am certainly not in a position to have such evidence), I believe this possibility [that is, an EHR-related information snafu - ed.] needs to be investigated fully.
I then did an update:
10/3/2014 Update:
My suspicions were apparently correct. [The hospital admitted an EHR role - ed.]
... "[ED physician Joseph Howard Meier's] notes in the medical records say he had reviewed the nursing
notes. Hospital officials told Congress that the ER physician several
times accessed portions of the electronic records where the nurse had
recorded Duncan’s arrival from Africa.
It wasn’t clear, though, “which information the physician read,”
hospital officials told Congress.
Meier told The News he hadn’t seen the Africa notation in Duncan’s
records. The physician said the hospital’s electronic medical records
system contained a lot of information, which, like patients, “must also
be triaged.”
Clinicians in an ED have to "triage" information from their records systems, just like patients need to be triaged? That is a candid and astonishing (to anyone with common sense) admission.
Paper charts never had those problems in my own time working in the ED.
Further, ED charts used to be relatively brief, which is why as a Chief Medical Informatics Officer I recommended document imaging systems only in ED's, to make charts available 24/7/anywhere, and data transcriptionists to capture important data into computers later, not full EHR systems where clinicians enter data which I felt (and still feel) are inappropriate in faced-paced, high-risk settings.
(Put another way, the experiments of direct data entry by busy clinicians, and clinicians attempting to drink information from a tangled cybernetic EHR firehose, are proving a failure.)
... The “travel information was not easily visible in my standard workflow,” he said. “This has now been modified very effectively.”
... The News asked Meier whether knowing Duncan’s travel history would have changed his evaluation.
“If he told me he came from Liberia, this would have prompted me to contact the CDC and begin an evaluation for
Ebola,” Meier said, “but the likelihood would have still been low since Mr. Duncan denied any sick contacts.”
Over the next few hours, Meier ordered tests, along with an IV for
saline. He prescribed extra-strength Tylenol, which the nurse gave
Duncan at
1:24 a.m.
Meier reviewed Duncan’s vital signs. CT scans of Duncan’s head were
“unremarkable,” the medical records say, showing no sign of sinusitis.
Doctors typically order CT scans to rule out more serious possibilities,
such as a hemorrhage or meningitis. In his responses to The News, Meier
said he ordered the CT scan because of Duncan’s headache.
Meier did not say whether the CT scan’s lack of an indication of
sinusitis factored into his diagnosis. “Sinusitis is mostly a clinical
diagnosis,” he said.
At 3:02 a.m.,
Duncan’s temperature was 103 degrees, his medical records say. Sixteen
minutes later, however, Meier entered a note saying: “Patient is feeling
better and comfortable with going home.”
Meier told The News he hadn’t seen the higher temperature in Duncan’s chart.
Duncan was discharged at 3:37 a.m. with the diagnosis of sinusitis. His last recorded fever, at
3:32 a.m.,
was 101.2 degrees. Meier prescribed Duncan the antibiotic Zithromax,
250-milligram tablets, to be taken twice the first day and once daily
for four more days.
I note two things:
1. If an EHR company has hiring practices allegedly such as described via Histalk blog at my Aug. 15, 2010 post "EPIC's outrageous recommendations on healthcare IT project staffing" (http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html), where rank-novice recent college graduates suddenly become EHR experts afters some transfusion of wisdom at corporate HQ (perhaps via this alien neural interface device that imparts the Knowledge of the Ancients: http://stargate.wikia.com/wiki/Repository_of_knowledge?), then what can one expect?
The Stargate neural interface device that imparts the Knowledge of the Ancients via direct brain download. Presto - instant EHR expert!
and
2. I note what I am going to somewhat satirically going to call the "Silverstein EHR principle", that states:
When bizarre and otherwise inexplicable information-related snafus occur in hospitals, especially in fast-paced, high-risk areas, suspect bad health IT as causative or contributory as #1 in your differential diagnosis (or post-mortem, as the case may be).
In the past several days the media has been abuzz with stories about the admission, then the following retraction, by a Texas hospital that and EMR "flaw" had caused a man who had been in West Africa and was infected with the Ebola virus to be sent home, instead of admitted and put into isolation.
A spectrum of the healthcare IT ecosystem seems represented (see http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem). The technology enthusiasts and hyper-enthusiasts seem to believe the computer could have done no wrong (and usually lack medical and Medical Informatics expertise).
Some people such as myself with specific Medical Informatics experience and who know the failure modes via AHRQ, FDA, ECRI Institute etc. believe the EHR was quite likely contributory or causative of the mistake (see my April 9, 2014 post "FDA on health IT
risk: "We don't know
the magnitude of the risk, and what we do know is the tip of the
iceberg, but health IT is of 'sufficiently low risk' that we don't need
to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).
The reason I have written little after my initial two posts is that the only was to resolve the controversy is to actually examine the EHR screens, screen navigation and behavior of the EHR, if possible both before and after the hospital's stated "fix" of the problem, the EHR audit trails (automatically generated EHR accounting logs of user accesses, action taken, time, location etc.) and to examine the EHR in actual operation to evaluate it in context with the clinical setting in which it was installed.
Barring that, everything else is speculation usually biased either by the speculator's own beliefs about either the beneficence or fallibility of information technology in healthcare, and perhaps IT generally, and/or conflicts of interest.
Unfortunately, considering the health IT industry and environment, the only way I believe such an examination of the EHR can come about is via litigation. I doubt it will come from the traditional regulators of medical devices and healthcare safety.
I do note the following of interest at Politico:
... While all EHRs difficult to use, some are set up better than others.
At Mount Sinai Hospital in New York City, information that a patient
was feverish and recently flew in from Liberia would have set off an
alarm, with the nurse’s screen flashing yellow and giving instructions
to immediately isolate the patient, said Jason Shapiro, an emergency
room physician and informatics expert at the hospital.
The nurse entering “fever” into the record would “get a hard stop.
They immediately have to enter a response to a travel history question.
And if there’s fever and the right kind of travel history, the whole
isolation mechanism is supposed to swing into play,” Shapiro said.
... Both Mount Sinai and Texas Health Presbyterian have health records
systems they purchased for hundreds of millions of dollars from Epic.
At least some users of EPIC seem to have a system configured to catch such a problem. In my mind, this speaks the need to industry regulation, to ensure all EHRs meet basic standards of safety and reliability and are not haphazardly designed or implemented from one hospital to the next.
-- SS
10/9/14 Addendum:
Prof. Jon Patrick of Australia, cited numerous times on this blog, relates this:
"I always talk about data capture and data reuse and the reuse is defined
by the data flows required in the design of the system. EPIC might well
have allowed for the the data capture but failed to deal with the data
flow to properly effect the required reuse."
As may the implementers at the hospital in question also have failed at the flows supporting appropriate and fail-safe reuse in a hectic ED environment.
He adds, for further clarification:
A footnote to this point. We separate data flow from work flow. Data flow is the movement of data from context to reuse in another
context, or you collect data on this screen(first context) and then you
see it later on another screen (=another context).
Workflow is
the route staff team members take in moving from one context to
another, that is the movement from using one screen to another screen.
Most often triggered by clicking a button that moves you to the chosen
screen(next context).
The two are very different things and
require close thinking in both cases to not trip up with unhelpful
and frustrating system solutions.
Historically, Information
Systems development has dealt with these issues both poorly and without
adequate separate planning. In the past the focus has been on the data
capture and storage, because the notion of reuse and context shifting
has been left behind. This has been OK for many business systems where
contexts have only small variations and workflow are simple or
unimportant.
At my Oct. 2, 2014 post "Did Electronic Medical Record-mediated problems contribute to or cause the current Dallas Ebola scare?" (http://hcrenewal.blogspot.com/2014/10/did-electronic-medical-record-mediated.html) I questioned a possible role for an EMR-related mishap, including known disruptions of teamwork and suboptimal presentation of information, to have contributed to or led to the release of a man carrying the Ebola virus from a Dallas Hospital.
I then related how the press reported, the very next day, that this was indeed the case.
Now...gee whiz...the hospital changes its tune. "No, it wasn't the EMR after all!"
The "new explanation" itself per the new article is that:
... A written statement Thursday said
hospital officials identified and
corrected “a flaw in the way the physician and nursing portions of our
electronic health records (EHR) interacted in this specific case.” That
statement implied, without directly saying it, that the flaw left the
doctor uninformed about Duncan’s travel history. In
Friday’s statement, though, the hospital said, “The patient’s travel
history was documented and available to the full care team in the
electronic health record.” “There was no flaw in the EHR in the
way the physician and nursing portions interacted related to this
event,” the statement said.
Again,
sounds like
redirection and making the doctor (and perhaps the ED doctor's group, if they were contractors) the sole scapegoat.
"Available to the full care team?" "Available" in a
complex computer system with myriad screens is a very relative term.
The issue seems not "how the physician and nursing portion interacted",
it is "how the physician portion made the information readily apparent to the physicians and other team members, or not."
The problem here, I believe,
still likely amounts to "information hard to find" and "suboptimal support of teamwork (situational awareness)", among others, per the AHRQ hazards taxonomy.
See, for instance, this. Either it is true, or not, regarding the travel history:
(click to enlarge)
I
think an impartial investigation is needed to get to the truth.
What we have now is likely healthcare defense attorney and/or risk management "fog", a phenomenon I have both professional and (sadly) personal experience with.
One also wonders if the EHR vendor had a contractual defects non-disclosure ("gag") clause with the organization, and is now threatening suit, leading to the retraction. (See http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda for more on that issue, and of corporate "hold harmless" clauses).
Unfortunately, a comprehensive investigation would be likely to only occur in a courtroom via Discovery if others become infected.
If any reader has knowledge of details, my email address is scotsilv AT aol DOT com.
-- SS
Addendum: A medical informatics colleague, Dr. William Goossen of the Netherlands, sent me a reminder about this article on the de-professionalizing aspect of health IT:
Harris
BL. Becoming de-professionalized: One aspect of the staff nurse’s
perspective on computer-mediated nursing care plans. Advances in nursing
science. 1990:
13, 2, 3-74.
Some content of this study - Nurses who participated in this study felt to some degree:
De-professionalized: being controlled by the computer, not formally planning individualized care, losing skills to develop NCP's (Nursing Care Plans).
De-autonomizing:
- control by supervisors - linear operations of the computer and
nurses felt to think like that - the system doesn't allow free texting,
-
nurses must follow the rules of the computer.
De-individualizing: - 'one-size-fits-all' - routinized care - eliminating creativity.
De-expertizing: - mindlessness and losing the skills learned in school, the computer does the work.
Oct. 1, 2014: Ebola-infected passenger was sent home from ER
DALLAS (AP) — The airline passenger who brought Ebola into the U.S.
initially went to a Dallas emergency room last week but was sent home,
despite telling a nurse that he had been in disease-ravaged West Africa,
the hospital said Wednesday in a disclosure that showed how easily an
infection could be missed.
The decision by Texas Health Presbyterian Hospital to release the
patient, who had recently arrived from Liberia, could have put others at
risk of exposure to Ebola before the man went back to the ER a couple
of days later, when his condition worsened.
... The patient explained to a nurse last Thursday that he was visiting
the U.S. from Africa, but that information was not widely shared, said
Dr. Mark Lester, who works for the hospital's parent company.
"Regretfully, that information was not fully communicated" throughout
the medical team, Lester said. Instead, the man was diagnosed with a
low-risk infection and sent home.
How could a "failure to fully communicate" information about the man's travels have occurred, at a time when the Ebola issue has been prominent in the press and is causing a worldwide scare?
The Texas Health System hospitals, including Texas Health Presbyterian Hospital Dallas, are EHR users and have been recipients of millions of dollars of federal incentives:
May 24, 2011: Texas Health Resources
has received more than $19.5 million in Medicare incentive payments for
meeting “meaningful use” criteria for installation and use of its
electronic health records.
It appears these hospitals are using EPIC. From a July 6, 2009 HIStalk blog interview with the CMIO:
What are the most important projects you are working on at Texas Health Resources? The project is our EHR deployment. We’re an Epic customer.
We’re in the middle of deploying the EHR. We’re live now with probably
close to three-quarters of our beds. We’re a 14-hospital health system.
EHR's are known to disrupt normal, even mundane channels of medical communication (my mother is dead thanks, in part, to this problem).
Per the Agency for Healthcare Research and Quality (AHRQ) of HHS, possibly relevant modes of disruption in this scenario include:
"information hard to find",
"suboptimal support of teamwork (situational awareness)",
"confusing information display",
"design contributed to entry into wrong patient's record",
"lost data",
"excessive workload (including cognitive)" ...
... and other potentially relevant factors (including system outage).
AHRQ Health IT Hazard Manager Report - Hazard Modes of Health IT (click to enlarge)
I've worked in ED's and find this matter puzzling. While I have no evidence as to any role of EHRs in this seemingly strange, cavalier and incomprehensible medical decision to send this man home, resulting in potential exposure of numerous other individuals to Ebola (and I am certainly not in a position to have such evidence), I believe this possibility needs to be investigated fully.
Finally, by the way, after all the tens of millions of dollars spent by this organization on EHR's at taxpayer expense and with the awards and accolades heaped on them by the likes of HIMSS, Leapfrog etc., at the very least one might have expected a blatantly obvious case like this to have been recognized as a serious matter. Yet it was not. (One can only imagine what happens with more subtle issues.)
One wonders how much in the real world, as opposed to in the world of EHR marketing and hype, these systems really do help in critical decision making and safety.
(CNN) -- The Texas hospital treating the first person diagnosed with
Ebola on American soil says a "flaw" in its electronic health records
prevented doctors from seeing the patient's travel history. Patient
Thomas Eric Duncan told the nurse he'd been in Africa, but that
information was entered into a document that isn't automatically visible
to physicians [apparently even after being filled out with positive information, I note - ed.], Texas Health Presbyterian Hospital Dallas said in a
statement Thursday. After discovering this, the hospital says it has
changed the system so doctors and nurses will see travel history
documentation. "We feel that this change will improve the early
identification of patients who may be at risk for communicable diseases,
including Ebola," the hospital said.
Well, yes it will. Perhaps that could have been thought of sooner? Additional thought: this situation might end up being the "Cybernetic Libby Zion case" I've been
predicting - where some major debacle leads to serious attention to EHR safety issues. (On Libby Zion, see http://en.wikipedia.org/wiki/Libby_Zion_Law.)
-- SS
10/4/2014 addendum:
Now...gee whiz...the hospital changes its tune. "No, it wasn't the EMR after all!"
The "new explanation" itself per the new article is that:
... A written statement Thursday said
hospital officials identified and
corrected “a flaw in the way the physician and nursing portions of our
electronic health records (EHR) interacted in this specific case.” That
statement implied, without directly saying it, that the flaw left the
doctor uninformed about Duncan’s travel history. In
Friday’s statement, though, the hospital said, “The patient’s travel
history was documented and available to the full care team in the
electronic health record.” “There was no flaw in the EHR in the
way the physician and nursing portions interacted related to this
event,” the statement said.
Again,
sounds like
redirection and making the doctor (and perhaps the ED doctor's group, if they were contractors) the sole scapegoat.
"Available to the full care team?" "Available" in a complex computer system with myriad screens is a very relative term. The issue seems not "how the physician and nursing portion interacted", it is "how the physician portion made the information readily apparent to the physicians and other team members, or not."
The problem here, I believe,
still likely amounts to "information hard to find" and "suboptimal support of teamwork (situational awareness)", among others, per the AHRQ hazards taxonomy.
See, for instance, this. Either it is true, or not, regarding the travel history:
(click to enlarge)
I
think an impartial investigation is needed to get to the truth.
What
we have now is likely healthcare defense attorney and/or risk
management "fog", a phenomenon I have both professional and (sadly)
personal experience with.
One
also wonders if the EHR vendor had a contractual defects non-disclosure
("gag") clause with the organization, and is now threatening suit,
leading to the retraction. (See http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda for more on that issue, and of corporate "hold harmless" clauses).
Unfortunately, a comprehensive investigation would be likely to only occur in a courtroom via Discovery if others become infected.
If any reader has knowledge of details, my email address is scotsilv AT aol DOT com.
Patient Safety and Health IT
Usability
Patient safety and usability continue to be a
focus for
ONC. Working with federal partners AHRQ and
FDA, ONC will create the foundation for a
patient safety program that will be launched in FY
2014called “The Patient Safety Plan”. The Plan
seeks
to ensure that health IT is safely designed
and
implemented, medical staff are
properly
informed and trained to use their health
IT
systems, and a surveillance system is
established
to monitor health IT related patient safety
events
and ensure that unsafe conditions are
corrected.
I believe the health IT industry now realizes some form of regulation is inevitable after, for example, revelations from medical malpractice insurers that a significant number of lawsuits involve the effects of health IT (see for instance my post "Malpractice Claims Analysis Confirms Risks in EHRs" at http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html).
I also believe that industry and its pundits have pushed for the most favorable regulation possible. This involves pushing for regulation by agencies with the least agency independence as possible, as I
bring out below.
HHS along with its member branches FDA, AHRQ and ONC
are executive departments of the US government The legislation that governs
the way such departments and agencies may propose and establish regulations is
the Administrative Procedure Act of 1946 (http://en.wikipedia.org/wiki/Administrative_Procedure_Act).
First, it seems the executive branch is attempting to concentrate more power within itself
over health IT through proposals like in the FY2014 HHS document.
"The heads of the federal executive departments,
known as
secretaries of their respective department, form the traditional Cabinet
of the United States, an executive organ that serves at the disposal of the
president
and normally act as an advisory body to the presidency."
In other words, the leaders serve at the pleasure of the President.
Independent
agencies of the United States federal
government are those agencies that exist outside of the federal
executive departments (those headed by a Cabinet secretary). More
specifically, the term may be used to describe agencies that,
while constitutionally part of the executive branch, are independent
of presidential control, usually because the president's power to
dismiss the agency head or a member is limited.
It is no secret the administration is determined to push as rapid as
possible rollout of health IT, come hell or high water, via HITECH, its
coming penalties and other measures. Its predecessor administration was
a bit more genteel and circumspect in this
regard.
It is clear to me that, in the current political environment, regulation
by a federal executive agency is minimalist and will likely be
politically ineffective, due to fear of its leadership of being
dismissed if they upset the upper echelons.
I note that Jeffrey Shuren, a physician and attorney, director of FDA CDRH already
stated in 2010 that "health IT is a political hot potato" as a reason
that FDA "has
largely refrained
from enforcing our regulatory requirements." See my April 2011 post "FDA Decides Regulating Implantable Defibrillator Medical Devices a 'Political Hot Potato'; Demurs" at http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html for links to source.
I believe it would be better to place the authority for health IT
regulation under the aegis of a federal independent agency, whether an
existing one or one created for that purpose, so that its leaders are
more independent of executive branch control.
-----
I predict that without meaningful regulation, this is where the health IT
industry will find itself in a few years.
Reuters - Federal prosecutors are examining whether General Motors is
criminally liable for failing to properly disclose problems with some
of its vehicles that were linked to 13 deaths and led to a recall last
month, according to a source familiar with
the investigation.
The New York-based probe is in its early stages, and the source did not
elaborate on the legal theory behind the potential criminal liability.
.. Federal investigators are reviewing information about how GM handled
reports of problems with ignition switches that first came to light 10
years ago, according to the source.
The federal probe by the U.S. attorney in Manhattan adds to a growing
list of U.S. authorities examining the recall, which GM announced in
February. The National Highway Traffic Safety Administration (NHTSA)
previously opened an investigation into whether GM
reacted swiftly enough in its recall.
Earlier on Tuesday,
Reuters reported that a U.S. Senate committee chairman is seeking a
hearing on the issue. The U.S. House Energy and Commerce Committee also
ordered GM and NHTSA to turn over information about GM's ignition switch
problems.
The problems in some instances allowed the engine and other components,
including front airbags, to turn off while the vehicle was traveling at
high speed. More than 1.6 million older vehicles are affected.
The failure is believed to be caused when weight on the ignition key,
road conditions or some other jarring event causes the ignition switch
to move out of the "run" position, turning off the engine and most of
the car's electrical components mid-drive, with
sometimes catastrophic results.
GM has recommended that owners use only the ignition key with nothing else on
the key ring.
.. The House committee examining the GM issue, led by Michigan Republican Fred
Upton, gave the company and NHTSA until March 25 to turn over information about their responses
to consumers' complaints about the problem.
The committee has asked GM officials to provide a briefing no later than March 18
on how GM has responded to reports of incidents since 2003 and its
interaction with NHTSA since then on problems related to the ignition
defect.
Upton led the 2000 investigation into Firestone tire failures on Ford
Motor Co vehicles, resulting in the TREAD Act that requires automakers
to report complaints of defects to the NHTSA.
That law also makes it a crime to intentionally mislead the agency about defects
that lead to serious accidents.
... The person familiar with the criminal probe declined to discuss whether
prosecutors were considering liability under the TREAD Act.
In fact, there is no good reason the health IT sector has been excluded from such actions, through an unprecedented regulatory accommodation this single healthcare sector has enjoyed for decades - namely, that of no true regulation at all.
Sure, let's regulate a potentially proven dangerous
healthcare technology, health IT (a glamor child of this administration)
by a federal executive agency that serves "at the disposal" of the President ...
instead of a federal independent agency, with ... uh ...better independence. Great idea!
-- SS
3/12/14 Addendum:
Note this report of possible delays by the Department of Transportation on disclosure of GM ignition defects, by its National Highway Traffic Safety Administration branch, that caused fatalities and where disclosure could have (and finally now has) resulted in huge legal problems for GM. GM is a company that was a centerpiece of the administration's economic interventions in recent years:
Did the Obama administration purposefully hide problems with GM cars? Were they panicked that a massive recall of GM products would undermine one of President Obama’s most self-congratulatory campaign themes – that he “saved” Detroit’s auto industry?
This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder.
The House Energy and Commerce Committee announced two days ago that it would undertake an investigation into why it took GM until quite recently to address a decade of complaints about stalling problems with several car models, and why the National Highway Traffic Safety Administration did not demand a recall of the troubled lines earlier on. [Because they were afraid to? - ed.] Reports of unexpected stalling in Chevy Cobalts began to trickle in as early as 2003 when 7 incidents were relayed to NHTSA, according to The New York Times ...
Read the whole article.
The Department of Transportation is ... you guessed it ... a federal executive agency, not a federal independent agency.
Did
the Obama administration purposefully hide problems with GM cars? Were
they panicked that a massive recall of GM products would undermine one
of President Obama’s most self-congratulatory campaign themes – that he
“saved” Detroit’s auto industry?
This is a tale of two car
companies: GM, shining star in President Obama’s reelection galaxy, and
Toyota, which became political fodder.
The House Energy and
Commerce Committee announced two days ago that it would undertake an
investigation into why it took GM until quite recently to address a
decade of complaints about stalling problems with several car models,
and why the National Highway Traffic Safety Administration did not
demand a recall of the troubled lines earlier on. Reports of unexpected
stalling in Chevy Cobalts began to trickle in as early as 2003 when 7
incidents were relayed to NHTSA, according to The New York Times.
- See more at: http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM#sthash.Ed9FH0ZD.dpuf
