... 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:
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.
- 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.
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.