Unintended errors with EHR-based result management: a case series, and a special pleading for health IT

As I wrote at "Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT", articles in the premier journal of Medical Informatics, the Journal of the American Medical Informatics Association (JAMIA) on real and potential downsides of health IT appear to be becoming a trend.

Another article just appeared in JAMIA as the result of a study of healthcare IT related errors: "Unintended errors with EHR-based result management: a case series"; Thomas R Yackel and Peter J Embi; JAMIA 2010 17: 104-107; doi: 10.1197/jamia.M3294.

The article presents a series of health IT-related errors and categorizes them systematically, and thus adds to our knowledge on the issue of cybernetic clinical test results management. It also makes recommendations for increased vigilance and remediation.

The abstract is below (access to the article itself requires a JAMIA subscription.)

ABSTRACT

Test result management is an integral aspect of quality clinical care and a crucial part of the ambulatory medicine workflow. Correct and timely communication of results to a provider is the necessary first step in ambulatory result management and has been identified as a weakness in many paper-based systems. While electronic health records (EHRs) hold promise for improving the reliability of result management, the complexities involved make this a challenging task. Experience with test result management is reported, four new categories of result management errors identified are outlined, and solutions developed during a 2-year deployment of a commercial EHR are described. Recommendations for improving test result management with EHRs are then given.

The article begins:

Over a 2-year period from 2005 to 2007, coinciding with the first 2 years of a planned 3-year deployment of the ambulatory EHR to multiple practice sites, the vast majority of laboratory result routing events functioned as intended. However, seven error types were identified as causing a substantial delay or disruption in result delivery to providers’ electronic inboxes [no statement is made about patient harm or "close calls" that may have resulted - ed.] and led to further investigations and case finding by our group.

Upon analysis, these seven error types were logically grouped into four distinct error categories: (1) interface and results routing logic errors, (2) provider record issues, (3) EHR system settings, and (4) system maintenance.

This was at OHSU, a leading institution in medical informatics, not at some organization that's a newcomer to health IT.

Each of the "error categories" is described in some detail. The article then makes recommendations for improved systems, which sound simple, but are going to be far more resource intensive on a national scale than meets the eye:

1. Develop fault-tolerant systems that automatically report delivery
failures.
2. Use robust testing to find rare errors that occur both within and between systems.
3. Implement tracking mechanisms for critical tests, such as cancer screening and diagnostics.
4. Deliver results directly to patients.

I find myself uncomfortable with the possible human resource costs of implementing the recommendations, especially on a national scale. These costs would be over and above the hundreds of millions per institution and the hundreds of thousands per private doctor already spent, or planned to be spent.

My other issue regarding the article (my main issue, actually) is its editorializing for a product, health IT, in a scientific article, and making a special pleading for the technology.

The next to last paragraph of the article appears more of an editorial, perhaps to make vendors comfortable, than a scientific statement of fact supported by the article:

Finally, while it might be tempting to attribute the errors noted above to the use of a particular health information system or even Health IT in general, an examination of the cases reveals that most of these errors actually resulted from local configuration and implementation decisions rather than to the technologies themselves. Indeed, the authors believe that these cases further support the emerging truism [wow! This is news to me - ed.] that errors related to Health IT are in most cases the result of human error in the implementation of new information and communication systems into our existing complex healthcare environments.[10] Therefore, we contend that the main lesson arising from these cases is that care must be taken by those responsible for implementing health information systems to remain aware of the kinds of errors that might occur and monitor for the unexpected consequences that will undoubtedly take place, but not to avoid use of such systems that likely have the capacity for far greater benefit than harm, if implemented and monitored properly.

In this paragraph the authors state: "... while it might be tempting to attribute the errors noted above to the use of a particular health information system or even Health IT in general, an examination of the cases reveals that most of these errors actually resulted from local configuration and implementation decisions rather than the technologies themselves."

As for "rather than the technologies themselves", technologies themselves are never a problem by themselves, even the atomic bomb. In a reductio ad absurdum, which is maybe not so absurd, it took a B29 Superfortress to drop two A-bombs; the bombs could have been deactivated and put in a museum instead.

However, consider a poorly designed A-bomb that could unpredictably go "BOOM" - now that would be a problem.

While I agree some errors are due to mismanaged implementation, in the article, no differentiation is made of design issues vs. implementation (i.e., local configuration and implementation decisions). Yet fundamental design is crucial, according to industry leaders and non-industry experts, in areas that cannot be vastly improved by local configuration decisions:

HIMSS's former Chairman of the Board admits the technology remains experimental:

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better;

While HIMSS itself admits in this 2009 PDF that

"Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available";

While the National Research Council (the highest scientific authority in the U.S.) last year reported that:

"Current Approaches to U.S. Health Care Information Technology are Insufficient" and that the technology "does not support clinicians' cognitive needs." The study was chaired by Medical Informatics pioneers Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt);

It is very difficult if not impossible to make a clinical IT silk purse out of a poorly designed sow's ear, no matter how many sound "local configuration and implementation decisions" are made.

Further, it is stated in the JAMIA article that human errors in implementation as the cause of health IT woes are an "emerging truism".

Making the case that some observation reflects a "truism" is a powerful claim. Such a claim deserves more than one reference, but here's what we have:

"... the authors believe that these cases further support the emerging truism that errors related to Health IT are in most cases the result of human error in the implementation of new information and communication systems into our existing complex healthcare environments" [10].

10. Ash JS, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Med Inform Assoc 2004;11:104–12.

Perhaps the term "truism", emerging or otherwise, should be avoided in 2010 regarding errors related to health IT.

The authors contend, presumably from the above observations that:

... we contend that the main lesson arising from these cases is that care must be taken by those responsible for implementing health information systems to remain aware of the kinds of errors that might occur and monitor for the unexpected consequences that will undoubtedly take place

"Might occur?" How about "that do occur" - as in the paper? Above all, these involve patients.

Unexpected consequences - these involve patients, too.

My mother was nearly killed by "unexpected consequences:" of health IT in May 2010. Perhaps that makes me less cavalier about health IT.

In fact, the certainty that UC's will "undoubtedly take place" reaffirms that these are still experimental technologies.

I remind that it might be best to focus on fundamental design issues before expensive systems are put into place that can cause errors and unexpected consequences, because these are mission critical systems involving live patients who have not, incidentally, been afforded informed consent to the use of these medical devices in their healthcare.

Another editorial comment follows:

[the lesson is that those responsible should remain aware] but not to avoid use of such systems that likely have the capacity for far greater benefit than harm, if implemented and monitored properly

Once again, this is an editorial and value judgment. Who knows if ultimately health IT has a capacity for far greater benefit than harm? If these systems will have predictable, unexpected consequences, how do we know that? Why should critical-thinking practitioners not avoid such systems for now until a better understanding of how to design them to improve usability and support clinician cognition is achieved?

Why put patients at risk en masse as part of a national experiment when studies even at advanced HIT sites show fundamental problems that could harm or kill?

I argue this paper and others that are "emerging" on the downsides and lack of ROI of health IT make the case for great caution and slowness (i.e., avoidance) in their adoption.

Yet the authors seek special accommodation for this technology, something that is perhaps unprecedented with (unregulated) medical devices of unknown risk.

The lesson is actually that we need to slow down with HIT; reboot and start to solve the problems of this technology before national rollout attempts.

This is the ethical position regarding any experimental medical technology that is proving risky at a level not clearly known.

-- SS

Is Healthcare IT a Solution to the Wrong Problem?

In a study published in the Nov. 25, 2010 New England Journal of Medicine entitled "Temporal Trends in Rates of Patient Harm Resulting from Medical Care", Landrigan N Engl J Med 363;22, it was found that medical error rates were not dropping:

In a study of 10 North Carolina hospitals [from January 2002 through December 2007], we found that harms remain common, with little evidence of widespread improvement. Further efforts are needed to translate effective safety interventions into routine practice and to monitor health care safety over time.

Unfortunately, I don't believe that the article differentiated between computerized hospitals and paper-based ones. Nor were the subject hospitals selected on the basis of computerization or non-computerization:

We conducted a retrospective study of a stratified random sample of 10 hospitals in North Carolina ...

... All acute care North Carolina hospitals listed in the American Hospital Association (AHA) database except those providing exclusively pediatric, rehabilitation, or psychiatric care were eligible for selection for the study. These hospitals were stratified according to the AHA’s definition of the facility as small, medium, or large; urban or rural; and teaching or nonteaching. The number of hospitals that underwent randomization for inclusion in each stratum reflected the proportion of national discharges from that type of hospital. If an invited hospital declined to participate, another closely matched hospital was randomly invited to participate in its stead.

While the extent of EHR/CPOE and other clinical IT adoption was not measured, some of the hospitals studied would likely have adopted and/or been using clinical IT in various capacities during the study period. The IT might have been expected to contribute to lower error rates over time.

Although that is admittedly speculation, there is a more important point to be made.

Many of the identified errors seem to have little to do with record keeping, but instead with human factors.

From the New York Times article "Study finds No Progress in Safety at Hospitals" covering the NEJM article:

... Landrigan’s study reviewed the records of 2,341 patients admitted to 10 hospitals — in both urban and rural areas and involving large and small and teaching and nonteaching medical centers ... Among the preventable problems that Dr. Landrigan’s team identified were severe bleeding during surgery, serious breathing trouble caused by a procedure being performed incorrectly, a fall that dislocated a patient’s hip and damaged a nerve and vaginal cuts caused by a vacuum extraction device used to help deliver a baby.

The findings were a disappointment but not a surprise, Dr. Landrigan said. Many of the problems were caused by the failure of hospitals to use measures that had been proved to avert mistakes and prevent infections from urinary catheters, ventilators and lines inserted into veins and arteries.

The chart of "harms" in the article, both those deemed "non-preventable" and those deemed "preventable" reads like a textbook of medicine, e.g.:

Cardiac arrest, shock, myocardial ischemia, acute respiratory failure, acute renal failure, hemorrhage, thromboembolic venous event, hematoma, pancreatitis, ileus, stroke or intracerebral hemorrhage, withdrawal symptoms, catheter-related bloodstream infection, urinary tract infection, surgical-site infection, clostridium difficile colitis, surgical anastomosis failure, wound dehiscence, failed procedure, unplanned return to surgery, fetal neonatal complication associated with delivery, hypothermia, pressure ulcer, catheter complication, etc.

It seems unlikely a missing or illegible chart was the cause of many of these adverse events. (In fact, the study was done retrospectively from the patient charts.)

Thus, expectations for major quality improvements in healthcare from the hundreds of billions spent on health IT might be vastly overstated based on false assumptions about the causes of adverse events.

Many of the above adverse events seem not highly amenable to correction via cybernetic information retrieval systems. They might be amenable, though, to improved nursing and ancillary staffing (perhaps I should say 'elimination of understaffing'), decreased work hours, improved CME, and better supervision of trainees ($100's of billions of dollars being spent for IT would surely buy a lot of those items).

What I found striking was this:

“A third of the errors in the intensive care unit disappear when residents work 16 hours or less,” Dr. Landrigan said, although he noted that senior residents often work longer hours.

That being the case, health IT that created heavier workloads and cognitive overload of residents already struggling under sleep deprivation might actually increase the risk of error.

It would seem national healthcare IT may be a 'solution' to the wrong problems in 2010.

We perhaps should better be focusing on human problems not amenable to cybernetic intervention before we start a national medical IT experiment, in the hope that major changes will somehow be effected by the magic of computers.

-- SS

The Economist, Information Privacy, Microsoft, and Technological Determinism: An Online Debate

At The Economist, an online "debate" entitled Health 2.0 has been posted (link). It poses a debate between two experts.

In this case, the debate is between Peter Neupert, Corporate vice-president, Microsoft Health Solutions Group, vs. Deborah Peel, MD, Founder, Patient Privacy Rights and leader of the Coalition for Patient Privacy.

The readers are asked to vote upon whether they agree or disagree with this statement:

This house believes that any loss of privacy from digitising health care will be more than compensated for by the welfare gains from increased efficiency.

Note the phrase "will be."

Readers are also permitted to post comments.

My response was as follows:

30/11/2010 19:16:26 pm

Dear Sir,

The premise of this entire debate is logically fallacious, in fact begging the question.

This statement implies proven or inevitable "gains" from health IT. This is far from certain.

Health IT such as electronic medical records systems and computerized order entry systems (CPOE) remain highly experimental medical devices. They are unregulated devices as well. Their effects on medical care can be toxic, and patients are exposed to these effects without informed consent. The "gains" attributed to them are increasingly doubted in a growing body of literature.

See

"Common examples of healthcare IT difficulties" at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/

and

"2009 a pivotal year in healthcare IT"
at
http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc...

for exposure to some of this literature.

In essence, management information systems and other business computing-derived approaches, customs and traditions for software design, development and lifecycle have proven ill suited in healthcare. Clinical computing and business computing are conflated; yet, they are two fundamentally different subspecialties of computing.

Further, medicine is a scientific discipline, yet the approach to IT in healthcare has been nearly devoid of science and critical thinking.

Sacrificing privacy for a dream that may or may not be true is not good social policy.

In the aftermath of the latest Wikileaks disclosures, a scientific approach - such as assertions about the beneficence of IT in healthcare not being made without strong, robust scientific evidence and without consideration of the downside evidence not being proferred so freely - would be a fine start.

S. Silverstein, MD
Drexel University
College of Information Science and Technology
Philadelphia, PA USA.

I found the position of Peter Neupert (Corporate vice-president, Microsoft Health Solutions Group) defending the motion particularly concerning:

Consumers must trust that the organisations they are engaged with are accountable and will respect—and protect—the privacy of their data.

"Must trust?"

I find this remarkable in the context of repeated violations of "trust" I've noted at this blog such as at my posts:

• "Networked EMR's and Healthcare Information Security: Practical When Massive IT Security Breaches Continue?",

• "Networked, Interoperable, Secure National Medical Records a Castle in the Sky?",

• "Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?",

• "Medical data breach of the week - but your EMR data is secure, trust us, we're IT experts",

• "Insurers Test Data Profiles to Identify Risky Clients",

• and others.

Neupert's view is especially paternalistic and naive in the context of Wikileaks repeatedly and recently leaking hundreds of thousands of supposedly secure documents, stolen from U.S. intelligence by at least one known person and probably others. If the Pentagon and U.S. intelligence cannot keep information secure, how can lowly hospital IT departments?

The moderator's initial comments are also disturbing:

... Supporters argue that health information technologies have advanced to the point that such [security] concerns are vastly overblown. After all, do not financial data flow freely and with little incident over digital systems? On this argument, any loss of privacy will be more than offset by efficiency gains. In arguing for the motion, Peter Neupert of Microsoft, a software firm, insists that digital medicine must be centred on the patient—rather than, say, the doctor or the insurer, as is often the case today [this 'centered on the patient' meme sounds good, but what exactly does it mean? - ed.] —and that medical information must be as mobile as the patient. If that is the case, he argues, it is not merely the efficiency of health systems that will improve but also the value of health care—and perhaps health outcomes too.

MR VIJAY V. VAITHEESWARAN
Correspondent, The Economist

Note the statements of absolute certainty - "will be more than offset by efficiency gains", "will improve", etc. They remind me of the statements made in the NEJM by the Director of ONC, Dr. David Blumenthal, as I wrote at "Science or Politics? The New England Journal and The 'Meaningful Use' Regulation for Electronic Health Records":

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

On that I had commented:

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced. I note the lack of footnotes showing the source(s) of these statements.

The meme of technological determinism, that computerization in medicine is synonymous with, and will deterministically provide "improvements", no matter what the evidence, is quite concerning coming from a company as profoundly large and influential as Microsoft.

Further, the complete omission of consideration of the adverse clinical consequences (let alone mere information breaches) that may occur along the way to cybernetic utopia in healthcare is very disturbing. These are experimental medical devices, are unregulated, and are used without patient informed consent. Yet the IT industry seems to opine as if these systems are only to be used on experimental lab rats.

These systems produce "legible gibberish" of no clinical use to clinicians, but take clinician time to generate through distracting "clickorrhea." For example, just the placement of an IV and fluid infusion generates a half page of nonsense:

Actual "legible gibberish" from an ED EHR report, major health IT vendor. Half a page on how an IV was started and a saline infusion given. (How many distracting clinician mouse clicks did it take to produce this?) Click to enlarge.

Addendum 12/8/10 - From "Hidden Malpractice Dangers in EMRs", Steven I. Kern, Esq., Medscape.com:

Too Much Information

... Pages of repetitive documentation can be more time-consuming to review than brief, handwritten notes. When important information is embedded in paragraphs of boilerplate, it can easily be overlooked. The chance of missing critical data increases.

Overlooking important information is, of course, a significant cause of malpractice. A positive finding embedded in a string of negative findings can easily be missed.

Ironically, my own mother was injured as a result of EHR-related disruption not long ago. Further, just the initial two and a half weeks of hospitalization generated more than 2,800 laser printed pages of "legible gibberish" (which cost just under $1000 to obtain; Kinko's should only have it so good).

A fellow physician I know well related:

From: [redacted name of MD]

Good Lord! I am so sorry to see this and hope your Mom gets better. You must be furious.

May I add to the cacophony? My wife went to [another local hospital's] ER for emergency transfusion. Their Emr displayed someone else's info under her name & SSN. Had I not been there she would have received incorrect treatment.

My wife went to [yet another hospital] for hip replacement. After surgery, while she slept off her anesthesia, a nurse came in and started injecting her. I asked and learned it was insulin. I stopped the nurse (with difficulty). My wife's not diabetic. Her screen showed someone else's orders. Had I not been there she might have died.

So keep up the good work... please!

[redacted name of MD]

How many other patients have been injured or killed as a result of EHR's?

In fact, we really don't know how many adverse events related to EHR's occur. As the Joint Commission itself admits in its Sentinel Events Alert #42, Safely implementing health information and converging technologies: "There is a dearth of data on the incidence of adverse events directly caused by HIT overall." I further wrote on this issue in a paper "A Dearth of Data on Unintended Consequences of Healthcare IT" here.

Is this a proper environment for national rollout of these clearly experimental medical devices, one should ask?

The memes of technological determinism and health IT "white-as-driven-snow" beneficence seem as difficult as vampires to eradicate.

Yet if this technology is to achieve the benefits of which it is capable via remediation of current IT industry customs, traditions and practices, these memes must be challenged and defeated.

Regarding health IT in the real world, reality matters.

-- SS

Avatar fails. (No, not the Cameron movie, but yet another lousy EMR system implemented by amateurs.)

A story "Designed for Efficiency, New Computer Software at Health Dept. Misfires" by The Bay Citizen senior writer Katharine Mieszkowski appeared in the New York Times today regarding San Francisco's Dept. of Public Health.

"Misfires?"

That's a mild term indeed. In the realm of incendiary comments in the interest of patient care:

In this story, mental health and social workers, and the disadvantaged people suffering mental illness, drug addiction, etc. that these professionals attempt to raise up from misery one difficult step at a time, are being used as unconsenting experimental subjects and free software debuggers and beta testers:

This story follows a script very familiar to Medical Informatics professionals:

• Poorly designed and implemented healthcare IT causes clinical and other chaos;
• Vendor and implementation leaders claims "glitches" and "teething pains" and blame the users for inexperience and/or incompetence;
• Vendor promises relief in the "next version";
• These principals hope it all "goes away" until the system implodes on itself and needs replacement, starting the cycle anew, and/or-
• The principals hope newspapers stop paying attention to the chaos caused by the IT and the users simply surrender, and let the information systems control them, rather than the other way around.

Considering the patient population involved here, one might wonder if the project leaders have any more compassion than the machines they proffer:

New York Times
Designed for Efficiency, New Computer Software at Health Dept. Misfires
By KATHARINE MIESZKOWSKI
November 18, 2010 (from the Bay Citizen)

In July, the San Francisco Department of Public Health started using an $11.2 million electronic medical records system, Avatar, that was designed to streamline billing and improve care for tens of thousands of clients. Thus far, however, it has brought administrative chaos to the mental health and substance abuse services in the city.

Documents obtained by The Bay Citizen under a California Public Records Act request show that shortly after installing Avatar, providers struggled to use the new software, causing health officials to lose track of millions of dollars of services.

Officials are scrambling to fill in the missing data to meet deadlines to qualify for reimbursement from the state.

In addition to mere financial chaos:

... Problems related to the conversion to Avatar delayed for months the payment of about $450,000 to individual therapists, Anne Okubo, the health department’s deputy financial officer, told the San Francisco Health Commission on Tuesday night. The department was forced to use a third party to make the payments, which are still incomplete.

In addition, some therapists and social workers report that the demands of the new software have cut into the time they spend with patients, eroding the quality of care.

In an Aug. 19 e-mail headed “problems with Avatar,” Steven Schreibman, a social worker at Sunset Mental Health, a city-run clinic, wrote that the software required “excessive time charting and performing data entry” and had led to “shorter sessions with clients” and “delays in our capacity to accept new clients.” [This is not news to anyone familiar with poorly designed, mission hostile healthcare IT - ed.]

The customary excuses were presented. Growing pains, ignorant users:

Senior health department officials and Netsmart Technologies, Avatar’s developer, said the problems were glitches that were to be expected as the city made the transition to a more efficient record-keeping system.

“We knew it was going to be rough initially, because there is a learning curve,” said Jo Robinson, who heads the Community Health Behavioral Services division, where Avatar was introduced.

Kevin Scalia, a Netsmart Technologies executive vice president, said that he does not see this as a big problem. “From our point of view,” he said, “everything is going swimmingly.” [Translation - they're making good money - ed.]

Here's the key passage:

Department managers told the Health Commission that Avatar would lead to “improved client care” and had “positive fiscal impacts,” but they acknowledged there had been problems.

In September, the department compared the cost of mental health and substance services reported by the hospital, clinics and organizations in March, before the software was put into use, to those reported in July using the new system.

The data showed that the mental health services reported had plunged 55 percent. Substance abuse services reported fell 32 percent. The large discrepancies caused alarm because they indicated that providers were having problems using the software, according to documents and interviews. [I can also predict they've had problems _providing_ those services under the time duress added by the software - ed.]

As someone who was once a Medical Review Officer for drug testing in the public transit industry, and a colleague of the company's Employee Assistance Program liaison, I can assure readers that implementation of health IT will not effect a one-third reduction in drug abuse problems and recidivism.

After a month of use:

A month later, as more providers gained access and proficiency with the software, the picture improved, but significant discrepancies remained.

Some data modeling issues are apparent:

But some organizations worry that the services they are providing will not be fully reflected in the new system.

Here's a reverse twist on HIT vendor "Hold Harmless" clauses:

At the Health Commission meeting, Estela Garcia, executive director of the Instituto Familiar de la Raza, a community organization that provides mental health services, asked the commission to protect organizations like hers from any financial liability related to Avatar.

“I want a hold-harmless policy until the system is fully up and running,” Ms. Garcia said.

How long that will take is unclear. One mental health program director, who would not allow his name to be used because it could jeopardize his relationship with the department, said his staff had gone to repeated training sessions to try to get up to speed.

“Avatar turns out to be a total disaster,” the program director said. “What is going to happen to contracted agencies if their billing is short at the end of the fiscal year as compared to the terms of their contract, because they can’t master Avatar?”

As in typical in health IT, system users are afraid to speak candidly:

A psychologist who works with a community organization under contract to the city, who spoke on the condition of anonymity because he was afraid of losing his job, said he used to do all his charting and billing on paper and was told that the new system would be more efficient. So far, that has not proved to be the case, he said.

“We are seeing the same number of patients,” he said, “but we are providing substantially less service to them, because the time we are now spending just to do the billing alone, not to mention the record keeping, it’s become the majority of our time.”

Labor unions are taking a look:

Greg Cross, a field representative for Service Employees International Union Local 1021, which represents hundreds of social workers, psychologists and counselors who work for the city, said he had met with officials to discuss Avatar’s impact on workload as well as performance expectations.

I invite SEIU Local 1021 and national SEIU leaders to read this blog, and review my academic site on HIT failure here, to better understand why these debacles repeatedly occur.

At the Health Commission meeting, Fred McGregor, the health department’s senior information technology manager for community programs, said that the department was aware that providers find the demands of Avatar “a little onerous” and that it was working on a redesign to make clinical assessment more efficient.

A "little onerous"?

"Working on a redesign to make clinical assessment more efficient"?

What about getting it right the first time, based on the significant amount of literature that exists on proper IT design?

I, for one, am tired of hearing this corporate mumbo-jumbo every time another health IT system impairs users.

What is needed here is a full scale investigation and evaluation of the competence and expertise of the project leaders, designers, and implementers to be experimenting in the complex field of healthcare information technology.

Mr. Schreibman, the social worker, made it clear in his August e-mail that change was needed quickly.

“The kind and amount of work skill involved using this software represents a change in our job description,” he wrote. “This is not the job we accepted when we chose to do clinical work for the city.”

In other words, they did not accept a job as data entry clerks and directors of workarounds to the mission hostile user experience presented by poorly designed healthcare information systems.

I note that missing in this story are the human tragedies (such as pain & suffering, injury, death) these IT "glitches" may have caused.

Until the memes of complete health IT beneficence and "anyone can do it" are soundly pounded into the ground and out of the heads of hapless politicians, healthcare leaders, and IT personnel, this type of mishap will continue.

Sadly, health IT mishaps are likely to be occurring on a national scale, soon, in a neighborhood near you, thanks to the timelines and penalties expounded in the HITECH act. HITECH was an integral part of the legislation known as the ARRA (American Recovery and Reinvestment Act of 2009).

-- SS

Medical center has more than 6000 "issues" with Cerner CPOE system in four months - has patient harm resulted?

As I have written at Healthcare Renewal before, computerized physician order entry systems (CPOE's) are known to present risks to patients through induction of medical errors.

This technology is held out to be ready for national diffusion, right up to the POTUS. Per ONC director Blumenthal in the July 13, 2010 NEJM:

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

Vendors deny major problems with their CPOE and other health IT products.

The true story is a bit more complex.

Fortunately, there are some medical centers who are open and honest about HIT problems. These medical centers seem a rarity. However, those that do share are actually conducting themselves in an honorable and mission-true manner, per Joint Commission Safety Standards, the ethics of the medical profession, and the expectations of the public. They should be commended.

One such example is Munson Medical Center in Michigan.

From the October 2010 "News for Physicians affiliated with Munson Medical Center" newsletter, a large medical center in Northern Michigan, about more than six thousand "issues" with their Cerner CPOE:

POE Program Continues to be Improved, Enhanced

The Provider Order Entry (POE) program continues to be improved. Since implementation in June [four months ago - ed.], more than 6,000 issues have been reported. Issues are defined as an aspect of the program not working as intended [does that include medication and treatment errors and 'near-misses'? - ed.], process issues [can these 'issues' kill? - ed.], education needs, or PowerPlan [Cerner - ed.] change requests.

About 600 of these remain open. Issues are prioritized by the POE Team and addressed according to existing standards.

One wonders how many of those 6,000, and how many of the 600 remaining "issues" fall into categories of "likely to cause patient harm in short term if uncorrected" or "may cause in patient harm in medium or long term."

I note that Cerner CPOE is not a new product, nor are similar products from other vendors also afflicted with long lists of "issues." That there could be more than 6,000 "issues" at a new site suggests deep rooted, severe problems with CPOE specifically and health IT design and implementation processes in general.

Did patient harm result here or at other CPOE sites (using products of any vendor, not just this one) that had hundreds or thousands of "issues"? We may never know.

That national rollout is mandated as if this technology were proven, safe, and plug and play is a scandal of UK NPfIT-like proportions.

-- SS

Cerner's Blitzkrieg on London: Where's the RAF?

In the Battle of Britain in WW2, the Royal Air Force (RAF) heroically repelled a foreign invasion of the UK.

The Supermarine Spitfire, key defense tool in the Battle of Britain. (Worked without major glitches.)

Now, the invasion is American, and the battlefield is healthcare...

I have often said health IT remains an experimental technology. However, the technology is being inexplicably force-fed with a vengeance to hospitals by IT companies and governments, force-fed with respect to the actual evidence of benefit.

In the case of the NPfIT in the UK, we have items such as those below from a 2009 government report "The National Programme for IT in the NHS: Progress since 2006 - Public Accounts Committee." Emphases in italics mine:

The termination of Fujitsu's contract has caused uncertainty among Trusts in the South and new deployments have stopped. One option being considered for new deployments is for Trusts to have a choice of either Lorenzo provided through CSC or the [Cerner, an American company - ed.] Millennium system provided through BT. There are, however, considerable problems with existing deployments of Millennium and serious concerns about the prospects for future deployments of Lorenzo. Before the new arrangements for the South are finalised, the Department should assess whether it would be wise for Trusts in the South to adopt these systems. Should either of the Local Service Providers take on additional commitments relating to the South, the Department should take particular care to assess the implications of the extra workload for the quality of services to Trusts in the Local Service Providers' existing areas of responsibility.

The Programme is not providing value for money at present because there have been few successful deployments of the [Cerner] Millennium system and none of Lorenzo in any Acute Trust. Trusts cannot be expected to take on the burden of deploying care records systems that do not work effectively. Unless the position on care records system deployments improves appreciably in the very near future (i.e. within the next six months), the Department should assess the financial case for allowing Trusts to put forward applications for central funding for alternative systems compatible with the objectives of the Programme.

In 2010 Londoners continue to be used as cannon fodder for the health IT experiment, which continues to rain IT bombs down upon them. The result?

Mayhem:

St George’s suffers Cerner teething pain
E-Health Insider
Jon Hoeksma
26 Aug 2010

St George’s Healthcare NHS Trust is facing teething problems with its installation of a Cerner Millennium hospital information system.

"Teething" problems? As if to imply problems with health IT are as minor as an infant's dental discomfort? That's some spin:

Health IT problems? Just baby issues; nothing a good cry can't solve ...

(The health IT baby must have serious endocrinological problems. Even after decades, it never seems to grow up, and is forever teething.)

The spin and excuses surrounding the health IT industry are simply nauseating, considering it's people's lives that are being screwed with.

Let's translate to everyday language: the project has been a disaster.

... The trust went live with the Millennium in March, under a new local delivery model from local service provider BT.

Five months later, the trust, which is one of the largest in London, has had to second additional senior management expertise into the project team and institute an additional programme of workflow changes and training.

The trust says the new system is creating difficulties in tracking patient notes in some areas and in managing outpatient appointments; creating backlogs of work that have required extra staff to deal with.

Health IT is touted as improving clinician-clinician communication. Allow me to translate "difficulties in tracking patient notes." In King's English (as opposed to health IT political-ese and other mumbo-jumbo), this translates to "patient notes are getting lost."

That means that health IT is obstructing patient care. I'm sure the patients didn't consent to the use of unproven technology that could get them killed.

Health IT is also the supposed cure to healthcare's financial and staffing woes:

They have also had a knock-on effect on the trust’s ability to meet and report on activity. Sources familiar with the implementation say the trust was fortunate that the coalition government dropped the national requirement to meet 18-week referral to treatment time targets in the revised NHS operating framework.

The problems are understood to mainly relate to staff finding it difficult to adjust to new processes and to using the unfamiliar Cerner system.

...“Since the programme deployed some staff have found it challenging to follow the new workflows. Therefore, where appropriate, we are simplifying processes by modifying workflows and administrative procedures.”

Translation: staff are finding it difficult to perform clinical-related work according to the capricious diktats of non-clinician health IT developers. In other words, they have difficulty being coerced to work for the computer, instead of the computer working for them.

The south London trust told E-Health Insider this week that the implementation was just the beginning of a major change programme; a project it calls iCLIP.

Only the beginning? God save the King....

“Although we successfully avoided some of the major pitfalls of other deployments, the new systems have presented some challenges to staff, particularly in relation to outpatient clinics and the tracking of case notes,” said chief operating officer Patrick Mitchell in a statement.

How major could those "major pitfalls" have been? Perhaps he means, the software actually runs and no longer crashes?

He added: “We have allocated additional temporary support while the new system and processes fully embed in these areas. A further programme of training and workflow changes are also underway as we continue to support staff and prepare for the next stages of the programme.”

"Temporary?" We'll see about that. Per the recent article "Electronic Medical Records, Nurse Staffing, and Nurse-Sensitive Patient Outcomes: Evidence from California Hospitals, 1998–2007" (Health Services Research, 9 APR 2010, DOI: 10.1111/j.1475-6773.2010.01110.x), on a longitudinal analysis of 326 short-term, general acute care hospitals in California:

... Our results suggest that advanced EMR applications may increase hospital costs and nurse staffing levels, as well as increase complications and decrease mortality for some conditions. Contrary to expectation [I'm not sure whose expectation, and on what basis - ed.], we found no support for the proposition that EMR reduced length of stay or decreased the demand for nurses.

On to the issues of skills:

Julia Crawshaw, the general manager for maternity services, has now been seconded into the project team “to lead on the work looking at optimisation of workflows, operational procedures and further training.”

Will this GM for maternity be looking at workflows in, for example, neurosurgery?

The problems now being addressed occurred despite 1,600 staff being comprehensively trained prior to go-live.

"Comprehensively?" What does that mean, exactly? The results seem to belie that assertion. Or are these systems and their user experience so ill conceived, tedious, cryptic and complex that no amount of "training" is adequate? (I believe the latter.)

However, Mitchell stressed that thanks to the hard work of staff, the new information system is delivering benefits, including “real-time reporting in the A&E department and more complete monitoring of bed occupancy.”

How many millions of pounds and person-years were spent to achieve these startling results, I wonder?

Mitchell said: “Reporting in real-time requires that staff report more promptly and accurately so additional training needs are also being identified to help individual staff become more comfortable with the system.”

Perhaps the system - and its designers - should be "trained" to be more comfortable with the users?

A spokesperson for BT told EHI: “Obviously these are operational issues the trust is dealing with. It is not for BT to comment. But you would expect that on a major deployment programme of this scale there would be issues.”

This is a classic appeal to common practice. Such "issues" might be tolerable for inventory systems of widgets (perhaps Cadbury Schweppes products?), but no, in mission critical areas I would not "expect" problems such as lost clinical notes.

In the most recent trust newsletter, the chief executive said: “I do fully appreciate that iCLIP has been far from smooth sailing. However, all major projects have their ups and downs and I know that many colleagues are focused on the long-term success of this important project.”

More spin and appeal to common practice.

This voyage was smooth sailing, until a little glitch was encountered...

"Far from smooth sailing?" Why does the HMS Titanic come to mind?

... The next trust due to go live with Millennium in London is meant to be Imperial, scheduled to take the system in 2011, under Cerner’s Method M delivery model.

"Method M delivery model"? How many "models" does it take to implement information systems in mission critical healthcare environments?

In summary, the NPfIT, already by the government's admission a multi-billion pound debacle, continues to drag on. Patients and hospital workers are the fodder for this experiment, spearheaded this time by an American invasion.

The Blitz is on.

Unfortunately, this time there's no RAF in sight to repel the foreign invasion.

The upside down world of commercial health IT. Is healthcare in St. George's Trust being incernerated?

-- SS

An Open Question on Moral Authority and Healthcare IT

AI recently had the chance to observe my mother's care in a small community hospital.

This was a hospital that, in her last several days there before going back to a nursing home for rehab, went live with a major vendor CPOE. The CPOE was brought in from a parent large hospital where the CPOE had been in use several years.

Just by passing the nursing station/doctor's charting room on my mother's floor and opening my eyes and ears, I saw doctors and nurses struggling to take care of patients while "getting the bugs out of the system."

They had had received some classroom "training" in a static environment, but it was clear they were learning about a lot of "gotcha's" and unanticipated glitches in vivo.

The fact of problems were predictable. In fact, I predicted unexpected difficulties to several of my mother's clinicians before go-live.

There was some skepticism (maybe in my nearly being in tears about my mother, I came off as a bit melodramatic). However, several later told me they "now knew what I was talking about" upon my mother's discharge, just several days into the go-live.

One story I overheard during go-live especially sticks out in my mind.

A newly-admitted patient who needed urgent heparinization did not receive the medication promptly. The patient's physician could not order it, and could not enter the required weight needed to order it, due to some type of 'glitch' or system malfunction. Physicians found no way to override, despite calls to the help desk, attempts by on site IT people and users from the parent hospital, etc.

In the end, the pharmacist simply provided the med using a weight estimate despite no "official" order having been entered into CPOE. I heard that the delay was on the order of "several hours."

Clearly, both technology and people issues were involved ... but I assure the reader, injured or dead patients really don't care exactly how their injury occurred, after the fact (other than in litigation, which doesn't fix the damage or remediate the suffering).

Here, then, is my question:

Where does the moral authority come from to subject live, unsuspecting, uninformed patients to the type of risks the patient whose heparin was delayed was subject to?

What right did the hospital have to NOT inform this patient before admission that a new critical CPOE system was going "live" that day, and that the patient could consider going to another hospital a few miles down the road instead that had no such potential problems?

From the Belmont Report (also see http://ohsr.od.nih.gov/guidelines/belmont.html ), the six fundamental ethical principles for using any human subjects for research are:

• (1) Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent;
• (2) Beneficence: maximizing benefits for the research project while minimizing risks to the research subjects; and
• (3) Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly (the fair distribution of costs and benefits to potential research participants.)
• (4) Fidelity: fairness and equality.
• (5) Non-maleficence: Do no harm.
• (6) Veracity: Be truthful, no deception.

I would like a straight, unspun answer to this simple question:

On the basis of Belmont Report and other medical ethics regulations, where does the moral authority come from for hospitals to put patients through such risks without informing them ahead of time and offering them an opt-out, even if only the continued use of paper in their care?

I have passed this question on to major American Medical Informatics Association mailing lists and await replies.

-- SS

The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room

The National Institute of Standards and Technology (NIST) has begun to address deficient clinical IT usability. A PDF with presentations on the topic from the recent NIST conference on HIT usability is here (warning: very large, 26 MB).

There is a critical "meta-issue" that's being ignored regarding usability, though, yet it is the elephant in the living room.

First, I will detail the elephant, then ask the simple, logical question that arises (the "inconvenient" question that nobody seems to be able to give a straight, non-marketing-spin answer to).

Here are the details of the elephant.

First, poor usability ---> increased risk to patients.

This is a first principle; it is not open to debate.

Now:

If NIST is just now getting involved in "improving HIT usability" (the improvement of which should have occurred at least two decades ago);

While HIMSS's former Chairman of the Board admits the technology remains experimental:

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better;

While HIMSS itself admits in this 2009 PDF that

"Electronic medical record (EMR)!adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available";

While the National Research Council (the highest scientific authority in the U.S.) last year reported that :

"Current Approaches to U.S. Health Care Information Technology are Insufficient" and that the technology "does not support clinicians' cognitive needs." The study was chaired by Medical Informatics pioneers Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt);

While it's not just the user experience that's the problem, either...

Insurers are starting to recognize this, e.g., "NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" ;

While hospitals and vendors cannot yet manage the technology reliably - how many medical mistakes have/will occur as a result of screw ups like this one, now confirmed to have occurred at a religious-denomination hospital chain headquartered in the Great Lakes region of the U.S.?

This patient won't get a second chance, either.

The above issues are the elephant in the living room. Or, shall I say, in the Boardrooms and meeting rooms where health IT is planned and discussed?

Health IT is great stuff, guys; it might actually work well one day!
Let's roll it out nationally and penalize those Luddite doctors
who refuse to "use it meaningfully" because it's not very usable.
Oh, just ignore that strange creature over there in the corner ...

Considering the size and weight of the elephant, here is my question:

Why are we rolling out this technology nationally under penalty of Medicare garnishment?

I cannot get a straight, unspun answer to that question.

Perhaps we need Bill O'Reilly to ask these questions of health IT officials on his FOX News program, The O'Reilly Factor, where spin is attacked relentlessly (the "No Spin Zone.")

-- SS

Barry Chaiken, MD, MPH: "Let's be patient" with experimental devices that harm patients

At an interview of Barry Chaiken, MD, MPH, FHIMSS, former Chairman of the Board of health IT trade group HIMSS and chief medical officer of Imprivata, a company specializing in healthcare IT security, Chaiken pleads for the following special accommodations for Health IT relative to other medical sectors:

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better.

[Why are the health IT applications bad to begin with, I ask? - ed.]

I note the following.

• If 'we're' still learning (and I don't include people with genuine clinical computing expertise in that subgroup, but it does include the plethora of amateurs in the commercial health IT industry), then the technology is experimental.
• Worse, it's unregulated - a major special accommodation in and of itself.
  
• These sentiments about "being patient" would be appropriate - if the subjects of this experimental technology that vendors need to be "given a chance" to make better were experimental lab rats.

Instead, the subjects of the experimental technology are unwitting, unconsenting human beings, who are being used as experimental test subjects for software development, and being put at risk, injured and indeed killed by the disruptions these experimental technologies cause.

Under these realities, the position presented by Chaiken is, in my opinion, ethically perverse.

That such sentiments come from someone who holds the MD degree and who I assume took the Hippocratic oath in some form is stunning.

In the health IT industry, "Primum non nocere" seems to have been replaced with "Kybernetik über alle."

Further, the commercial health IT vendors have had the good part of five decades to "get it right." How long is long enough?

Their software is unavailable for detailed evaluation and open critique of the user experience by impartial experts, unlike open source EHR's like VistA CPRS, demo version available at this link where anyone can:

• Download the latest version of CPRS today and get access to new features including graphing functionality
• Use the software as if you were a provider by entering orders, entering documentation, retrieving reports (and graphs) and viewing alerts and notifications that help with decision support
• Learn first hand how VA’s electronic health record system works

Personally, I've had to use stealth simply to obtain and post graphical representations of some simply inexcusable commercial HIT interface sins (link). Why should a secretive industry be given additional special accommodation?

Dr. Chaiken goes on to state:

Let’s hold them accountable if they don’t [make the applications better]. Absolutely, hold them accountable if they don’t; and the marketplace, I hope, will be able to make those choices and hold them accountable when they don’t. But, we’re still learning.

Again, I'm not sure who the "we're" refers to, but "holding companies accountable" will not really help victims of the experiments who are seriously injured or killed.

A better solution, as I have written on this blog (such as at my Nov. 2008 post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and at other sites as well:

Protect patients. Constrain the health IT experiment temporally and geographically, and apply the laws, customs and regulations of medical experimentation until this industry "has learned" whatever lessons Chaiken thinks they need to learn, e.g., from decades of Medical Informatics, Social Informatics, Computer Science, HCI and other research. None of these fields - last time I looked - are classified or protected intellectual property. Share information on patient adverse outcomes and near misses, instead of concealing them and contractually gagging users from openly speaking about problems.

That would be the ethical approach.

Further, how many more decades should we wait for the health IT industry to figure out how to look for better leaders beyond the "school of hard knocks" bias that's existed for at least the past decade? How many substandard health IT leaders were placed in hospitals the past few decades as a result of outrageous attitudes like these below from the major recrutiers, centered on spreading the wealth?

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman. Healthcare Informatics, "Who's Growing CIO's."

[No, that line about 'being consumed with patient care issues' as a strike against health IT leadership didn't come from a Scott Adams business-idiot parody cartoon - ed.]

As in clinical medicine itself, if you're going to be anywhere near patient care and making decisions affecting its delivery, a degree damn well "gets you something."

At about the same time the above appeared in Healthcare Informatics, a generalist IT recruiter wrote me this:

... What is happening to MDs trying to change careers is providing a window into broader issues about professionals in society today - narrow training, pigeonholing in the marketplace, difficulty making lateral and cross-industry transition, what a handicap it is to be creative, entrepreneurial, or cross-disciplinary in the current marketplace, and the wasted intellectual capital represented by the high caliber of individuals who can't find ways to fruitfully plug themselves into the marketplace.

I continue to be amazed at this general phenomenon...the remarkable quality of a number of candidates I've met, and the lack of recruiters' ability to get them in the door of good companies. The interesting part of the story is that when I am able to get access to high level execs in some of these companies (not just IT, but devices, pharmaceuticals, etc. also) they are dismayed at the quality of those that they hire. They know that something is wrong in how the recruitment process is working. (eg, one of the major device cos. just devoted the time of 1 FTE in Human Resources to 'finding innovative ways of identifying and recruiting good talent into the company.')

Whose fault were the outrageous, deleterious hiring practices prevalent in this industry that contributed materially to its production of substandard products, hiring practices that persist to this day? (See example here.)

Why should we be "patient", and "give them [yet more chances] to figure out the right way to do this", and why should patients permit themselves to continue to be guinea pigs to such a sloppy, cavalier industry?

I note that Chaiken's credentials appear to fit the template, as colleague Roy Poses describes at various posts including here, of an "executive isolated from the real world of health care" and member of the superclass. From the interview linked above:

... According to your LinkedIn profile, you’re CMO for Imprivata, CMIO for Symphony Corporation, and CMO of DocsNetwork. You’re on a couple of advisory boards, you own a vineyard, and you just finished your term as chair of the HIMSS board.

Perhaps that helps explain the mantra of "computers [and profit] first, patients second."

Finally, in answer to my own question above "Why are the health IT applications bad to begin with", I suggest complacency, incompetence, willful ignorance, and negligence (including criminal negligence) as possible answers.

-- SS

Addendum:

The following in today's WSJ caught my eye ("What we've learned from the Gulf spill", Michio Kaku, July 20, 2010):

The nagging question is: Why did it take so long? Why couldn't they have capped the leak months ago? For three agonizing months, BP's engineers and executives were essentially making things up as they went along, conducting a billion dollar science project with the American people as guinea pigs. The basic science of stopping oil leaks at 5,000 feet below sea level should have been done years ago.

Concepts are similar. With just a few edits, we have this:

The nagging question is: Why is it taking so long? Why couldn't they have learned to create useful health IT decades ago? For at least thirty agonizing years, Health IT vendors' engineers and executives were essentially making things up as they went along, conducting a multibillion dollar science project with the American people as guinea pigs. The basic science of producing safe, effective, usable health IT should have been done years ago.

-- SS