What to do about the state of the ED EHR's in NSW?

At my post yesterday "On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts", I've come down pretty hard on internal and external (i.e., human interface) sloppiness in mission critical IT systems.

In my view, the flaws that create randomly-occurring errors, combined with a mission hostile user experience highly and especially inappropriate in the hectic and unpredictable ED environment, turn these systems into slot machines. The jackpot, however, is not wealth. It's injury or death.

I've been asked, "So - what to do about the state of the ED EHR in NSW?"

Here are some simple initial suggestions:

A. For the time being: securing and implementing a paper backup (pen & paper) with scanning and document imaging retrieval system (integrated or standalone) as an 'EHR supplement", in order that really critical info can be steered in that direction.

Clinicians are already avoiding the EHR system and not entering or minimizing data, or using other "workarounds." Therefore, informationally and safety-wise, a document imaging/retrieval system for paper would probably be a net plus.

ED charts are not Tolstoy novel-length, as a matter of fact. There would not be many pages per patient, but even small morsels of key information collected easily and quickly, then retrieved easily, and presented clearly, cleanly and rapidly, as on a sheet or three of physical, then virtual parchment, can have enormous value.

B. Clinicians and responsible executives and officials should start demanding that the ED EHR vendor release its full conceptual and logical data models so that others can, competitively (including the original vendor if they wish), cleanse it and redo a user interface that meets the needs of NSW ED's. The latter should be determined collaboratively with the key stakeholders, and developed using agile, iterative and incremental methodologies, not the usual stale Management Information Systems approach. (I.e., the mercantile, manufacturing and management computing paradigms that are ill-fitting to healthcare informatics as further explained at my post here.)

That way moving data over to the "redone" new system would not be a nightmare. Or perhaps less of a nightmare than an entirely new extant system from another vendor (which would likely have similar flaws anyway and need similar rework).

The closed-system, locked-in-to-one-vendor paradigm that's apparently holding the ED's of an entire state of the fine country of Australia hostage must end. Let the best organization win.

As I also observed in the aforementioned post, the UK, having their own HIT issues (see my Aug. 2010 "Battle of Britain" post at this link), apparently learned something, as evidenced in:

Health Informatics — Application of clinical risk management to the manufacture of health software. UK National Health Service, DSCN14 (2009), formerly ISO/TS 29321:2008(E).

and

Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software. UK National Health Service, DSCN18 (2009), formerly ISO/TR 29322:2008(E).

Perhaps those in the U.S. and in VK-land (amateur-radio speak for Australia; I am KU3E here in the U.S.) can also heed these documents and their recommendations.

-- SS

Mar. 8, 2011 addendum:

Prof. Patrick has added a new section to his report, entitled "The Future Pathways for e-Health in NSW." It is available at this link (PDF).

It inoculates against most of the 'Ten Plagues' that bedevil health IT projects (such as the IT-clinical leadership inversion, magical thinking about the technology, and lack of accountability):

More on the Pathways at my post here.

The de facto "National Program for IT in the HHS" here in the United States needs a similar inoculation.

--SS

What to do about the state of the ED EHR's in NSW?

At my post yesterday "On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts", I've come down pretty hard on internal and external (i.e., human interface) sloppiness in mission critical IT systems.

In my view, the flaws that create randomly-occurring errors, combined with a mission hostile user experience highly and especially inappropriate in the hectic and unpredictable ED environment, turn these systems into slot machines. The jackpot, however, is not wealth. It's injury or death.

I've been asked, "So - what to do about the state of the ED EHR in NSW?"

Here are some simple initial suggestions:

A. For the time being: securing and implementing a paper backup (pen & paper) with scanning and document imaging retrieval system (integrated or standalone) as an 'EHR supplement", in order that really critical info can be steered in that direction.

Clinicians are already avoiding the EHR system and not entering or minimizing data, or using other "workarounds." Therefore, informationally and safety-wise, a document imaging/retrieval system for paper would probably be a net plus.

ED charts are not Tolstoy novel-length, as a matter of fact. There would not be many pages per patient, but even small morsels of key information collected easily and quickly, then retrieved easily, and presented clearly, cleanly and rapidly, as on a sheet or three of physical, then virtual parchment, can have enormous value.

B. Clinicians and responsible executives and officials should start demanding that the ED EHR vendor release its full conceptual and logical data models so that others can, competitively (including the original vendor if they wish), cleanse it and redo a user interface that meets the needs of NSW ED's. The latter should be determined collaboratively with the key stakeholders, and developed using agile, iterative and incremental methodologies, not the usual stale Management Information Systems approach. (I.e., the mercantile, manufacturing and management computing paradigms that are ill-fitting to healthcare informatics as further explained at my post here.)

That way moving data over to the "redone" new system would not be a nightmare. Or perhaps less of a nightmare than an entirely new extant system from another vendor (which would likely have similar flaws anyway and need similar rework).

The closed-system, locked-in-to-one-vendor paradigm that's apparently holding the ED's of an entire state of the fine country of Australia hostage must end. Let the best organization win.

As I also observed in the aforementioned post, the UK, having their own HIT issues (see my Aug. 2010 "Battle of Britain" post at this link), apparently learned something, as evidenced in:

Health Informatics — Application of clinical risk management to the manufacture of health software. UK National Health Service, DSCN14 (2009), formerly ISO/TS 29321:2008(E).

and

Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software. UK National Health Service, DSCN18 (2009), formerly ISO/TR 29322:2008(E).

Perhaps those in the U.S. and in VK-land (amateur-radio speak for Australia; I am KU3E here in the U.S.) can also heed these documents and their recommendations.

-- SS

Mar. 8, 2011 addendum:

Prof. Patrick has added a new section to his report, entitled "The Future Pathways for e-Health in NSW." It is available at this link (PDF).

It inoculates against most of the 'Ten Plagues' that bedevil health IT projects (such as the IT-clinical leadership inversion, magical thinking about the technology, and lack of accountability):

More on the Pathways at my post here.

The de facto "National Program for IT in the HHS" here in the United States needs a similar inoculation.

--SS

Institute of Medicine Committee on Patient Safety and Health Information Technology, and Thoughts on Social Aspects of Health IT Evaluation

March 2011 addendum: also see my thoughts on Meeting two of the Committee on Patient Safety and Health Information Technology at this link.

The U.S. National Research Council of the National Academy of Sciences issued a report in early 2009 on the state of health IT.

That study's report, led in part by pioneers in Medical Informatics G. Octo Barnett and William Stead, was entitled "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions" (pre-publication PDF available free at this link). The report was announced under the following header:

CURRENT APPROACHES TO U.S. HEALTH CARE INFORMATION TECHNOLOGY ARE INSUFFICIENT

The insufficiencies were largely in the areas of difficulties with data sharing and integration, deployment of new IT capabilities, large-scale data management, and lack of cognitive support by health IT for busy clinicians.

One might reasonably conclude such deficits could affect patient safety.

Recently the Institute of Medicine (the health arm of the National Academy of Sciences) formed a Committee to study health IT safety. It held its first meeting on Dec. 14, 2010 (quite a few years late in my opinion, and only after tens of billions of dollars have been earmarked for health IT, but better late than never):

The Institute of Medicine Committee on Patient Safety and Health Information Technology is holding its first meeting on December 14-15, 2010. The first day, December 14, 2010 beginning at 10:30 am, is open to the public to observe the committee proceedings. The committee will hear presentations by the Office of the National Coordinator and other invited guests. There will also be an opportunity for members of the public and representatives of interested organizations to make a brief statement before the committee. Prior registration is requested for attendees and required for those wishing to make a statement.

Participant lists and materials from that first meeting are available at this link.

This brings to mind some thoughts on the social aspects of health IT evaluation.

At a website by Dr. David Healy (link) on mass over-promotion and clinical trial data irregularities regarding SSRI's, academic abuses towards critical thinkers, and related affairs, I note an interesting observation in the preface. The author states:

"On the face of it, the investigation of possible hazards posed by SSRIs does not seem to have followed the conventional dynamics of science, where anomalies in the data are supposed to spur further investigation. In this case, debate has been closed down rather than opened up. Journals that might have been thought to be independent of pharmaceutical company influence have “managed” not to publish articles and the appropriate scientific forums have “managed” not to debate the issues."

This sounds eerily familiar with regard to another domain in biomedicine - health IT.

Allow me to substitute a few words:

"On the face of it, the investigation of possible hazards posed by clinical information technology does not seem to have followed the conventional dynamics of science, where anomalies in the data are supposed to spur further investigation. In this case, debate has been closed down rather than opened up. Journals that might have been thought to be independent of information technology company influence have “managed” not to publish articles and the appropriate scientific forums have “managed” not to debate the issues."

Only recently do I note this phenomenon starting to lift. I've aggregated a number of reports and articles of recent years that take a critical-thinking attitude about health IT safety, efficacy, and sociopolitical matters such as here and here. I intend to broaden and deepen this aggregation to make it more comprehensive in the coming months.

This is a somewhat personal exercise as my mother was severely injured in May 2010 by health IT interference with clinician communications, as at the banner at top of my longstanding website on HIT difficulties (link).

However, it's also a professional endeavor. I will be presenting at a regional health care attorney's meeting in a few months on health IT risks. In my talk I will undoubtedly recommend aggressive litigation when HIT is implicated in patient injury, and investigations of potential contributions of health IT to medical malpractice when not readily apparent. I am not alone in this stance.

Several weeks ago I also asked the IOM Committee on Patient Safety and Health Information Technology to be allowed to present my mother's case at some point, a tragic and ironic example of a family member of a physician and Medical Informatics specialist (not just a layperson) injured as a result of health IT. I have not yet received a reply.

Evaluation of health IT will likely become more than an academic endeavor in the next few years. Those engaged in it might find themselves called as expert witnesses - or as defendants.

I see a legal storm approaching in health IT. This is a domain I am somewhat familiar with, as pre-informatics I was a medical officer in public transit making safety-related medical decisions on transit authority/DOT-related matters, at a time when nationally-mandated random drug testing in the industry had recently begun. The legal implications of such work can be quite unexpected - and profound, especially when interfered with by outside sources with conflict of interest (e.g., labor unions). Train wrecks - literally, accompanied by litigation through the roof.

To those involved in health IT, this is not a scientific opinion, and thus feel free to ignore it.

At your own peril IMO.

-- SS

Institute of Medicine Committee on Patient Safety and Health Information Technology, and Thoughts on Social Aspects of Health IT Evaluation

March 2011 addendum: also see my thoughts on Meeting two of the Committee on Patient Safety and Health Information Technology at this link.

The U.S. National Research Council of the National Academy of Sciences issued a report in early 2009 on the state of health IT.

That study's report, led in part by pioneers in Medical Informatics G. Octo Barnett and William Stead, was entitled "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions" (pre-publication PDF available free at this link). The report was announced under the following header:

CURRENT APPROACHES TO U.S. HEALTH CARE INFORMATION TECHNOLOGY ARE INSUFFICIENT

The insufficiencies were largely in the areas of difficulties with data sharing and integration, deployment of new IT capabilities, large-scale data management, and lack of cognitive support by health IT for busy clinicians.

One might reasonably conclude such deficits could affect patient safety.

Recently the Institute of Medicine (the health arm of the National Academy of Sciences) formed a Committee to study health IT safety. It held its first meeting on Dec. 14, 2010 (quite a few years late in my opinion, and only after tens of billions of dollars have been earmarked for health IT, but better late than never):

The Institute of Medicine Committee on Patient Safety and Health Information Technology is holding its first meeting on December 14-15, 2010. The first day, December 14, 2010 beginning at 10:30 am, is open to the public to observe the committee proceedings. The committee will hear presentations by the Office of the National Coordinator and other invited guests. There will also be an opportunity for members of the public and representatives of interested organizations to make a brief statement before the committee. Prior registration is requested for attendees and required for those wishing to make a statement.

Participant lists and materials from that first meeting are available at this link.

This brings to mind some thoughts on the social aspects of health IT evaluation.

At a website by Dr. David Healy (link) on mass over-promotion and clinical trial data irregularities regarding SSRI's, academic abuses towards critical thinkers, and related affairs, I note an interesting observation in the preface. The author states:

"On the face of it, the investigation of possible hazards posed by SSRIs does not seem to have followed the conventional dynamics of science, where anomalies in the data are supposed to spur further investigation. In this case, debate has been closed down rather than opened up. Journals that might have been thought to be independent of pharmaceutical company influence have “managed” not to publish articles and the appropriate scientific forums have “managed” not to debate the issues."

This sounds eerily familiar with regard to another domain in biomedicine - health IT.

Allow me to substitute a few words:

"On the face of it, the investigation of possible hazards posed by clinical information technology does not seem to have followed the conventional dynamics of science, where anomalies in the data are supposed to spur further investigation. In this case, debate has been closed down rather than opened up. Journals that might have been thought to be independent of information technology company influence have “managed” not to publish articles and the appropriate scientific forums have “managed” not to debate the issues."

Only recently do I note this phenomenon starting to lift. I've aggregated a number of reports and articles of recent years that take a critical-thinking attitude about health IT safety, efficacy, and sociopolitical matters such as here and here. I intend to broaden and deepen this aggregation to make it more comprehensive in the coming months.

This is a somewhat personal exercise as my mother was severely injured in May 2010 by health IT interference with clinician communications, as at the banner at top of my longstanding website on HIT difficulties (link).

However, it's also a professional endeavor. I will be presenting at a regional health care attorney's meeting in a few months on health IT risks. In my talk I will undoubtedly recommend aggressive litigation when HIT is implicated in patient injury, and investigations of potential contributions of health IT to medical malpractice when not readily apparent. I am not alone in this stance.

Several weeks ago I also asked the IOM Committee on Patient Safety and Health Information Technology to be allowed to present my mother's case at some point, a tragic and ironic example of a family member of a physician and Medical Informatics specialist (not just a layperson) injured as a result of health IT. I have not yet received a reply.

Evaluation of health IT will likely become more than an academic endeavor in the next few years. Those engaged in it might find themselves called as expert witnesses - or as defendants.

I see a legal storm approaching in health IT. This is a domain I am somewhat familiar with, as pre-informatics I was a medical officer in public transit making safety-related medical decisions on transit authority/DOT-related matters, at a time when nationally-mandated random drug testing in the industry had recently begun. The legal implications of such work can be quite unexpected - and profound, especially when interfered with by outside sources with conflict of interest (e.g., labor unions). Train wrecks - literally, accompanied by litigation through the roof.

To those involved in health IT, this is not a scientific opinion, and thus feel free to ignore it.

At your own peril IMO.

-- SS

New York Times: Panel Set to Study Safety of Electronic Patient Data

New York Times author Milt Freudenheim has published an interesting article on health IT:

"Panel Set to Study Safety of Electronic Patient Data" (Dec. 13, 2010, link)

In the article Mr. Freudenheim presents various viewpoints on health IT safety and usability, and reports on an upcoming Institute of Medicine (IOM) Committee on Healthcare IT safety.

In general, the expressed viewpoints reported upon are consistent with the position in the Healthcare IT Ecosystem of those quoted. I wish to add some commentary to a number of those stated positions.

Mr. Freudenheim observes:

Taking a fresh look at such concerns, the Institute of Medicine created the Committee on Patient Safety and Health Information Technology to run a yearlong study and issue recommendations. The 16-member panel is meeting for the first time on Tuesday in Washington.

(This new IOM Committee is in addition to a 2009 study by the National Academies/National Research Council that concluded that "Current Approaches to U.S. Health Care Information Technology are Insufficient", which has largely been invisible. The IOM is the health arm of the National Academies.)

I would add that this Committee is at least a decade late. That it is occurring at all seems to be at the behest of a multitude of complaints and "blows of the whistle" from clinicians who increasingly depend (either voluntarily or by coercion) on this technology to provide safe care.

I would also add that it is my hope the IOM committee with not be overly politicized, considering the stated unconditional exuberance of the past two administrations towards health IT, and that a wide variety of stakeholders will be heard. (For instance, as a medical informatics specialist whose mother was injured as a result of HIT interference with clinician communications, will I be allowed to testify?)

Mr. Freudenheim then relates the points of view of stakeholders.

In February, the F.D.A. said it had received 260 reports of malfunctions related to health information technology “with the potential for patient harm,” including 44 reported injuries and six reported deaths in 2008 and 2009. The malfunctions were reported voluntarily to the agency, mainly by hospitals.

“Because these reports are purely voluntary, they may represent only the tip of the iceberg,” said Dr. Jeffrey Shuren, a senior F.D.A. policy and enforcement official.

I'd written about this at "FDA on Health IT Adverse Consequences: 44 Reported Injuries and 6 Deaths, Probably Just Tip of Iceberg" where I noted:

This is a technology almost universally touted as inherently beneficial, right up to our most senior elected leaders, who are now pushing this unproven technology under threat of penalty for non-adopters.

Healthcare IT irrational exuberance can perhaps be illustrated in statements such as this:

“We have the capacity to transform health with one thunderous click of a mouse after another,” said (former) HHS Secretary Michael Leavitt - 2005 HIMSS Summit

I also opined at "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers" that one could, as a type of thought experiment, extrapolate from these numbers to guesstimate the effects of universal health IT in the US. The results were startling, even if just an experiment:

[We might have] 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved ... While this is a mere thought experiment, the result certainly suggests we need to know the actual rates of HIT-related patient harm, and act to understand and minimize these events.

In setting national healthcare policy, we should not rely on thought experiments - but even more importantly, we should not be relying on guesswork and wishful thinking as we are currently.

Unfortunately, national policy has been set up to now on wishful thinking. As I stated, the IOM meeting is coming none too soon.

The NYT article then reports on a statement made by ONC Chair David Blumenthal:

“All options for assuring safety are on the table,” said Dr. David Blumenthal, the Obama administration’s national coordinator for health information technology.

Yet Dr. Blumenthal is clearly an adherent to unbridled exuberance about health IT. At "Science or Politics? The New England Journal and the 'Meaningful Use' Regulation for Electronic Health Records" I wrote:

... In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

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.

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.

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.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. [Followed by a list of such literature just off the top of my head - ed.]

Dr. Blumenthal then appeals to authority:

Dr. Blumenthal said health information experts like Dr. Donald M. Berwick, the Medicare and Medicaid administrator, and Dr. Brent James, of Intermountain Healthcare, based in Salt Lake City, “agree that electronic health records will improve the safety of care.”

I am unaware of the expertise of Dr. Berwick and Dr. James in this domain, and the peer reviewed literature they've written that supports such a statement while soundly refuting literature written by other experts that indicates otherwise.

(Perhaps at Intermountain, custom systems that took decades to develop utilizing their Medical Informatics expertise do show safety gains, but such systems and the lessons learned building them are not easily portable to a country's worth of organizations and practitioners, especially under HITECH timeframes.)

Freudenheim then quotes Blumenthal as stating:

“At the same time, any time you change the world you create risks,” Dr. Blumenthal said in a telephone interview last weekend.

This sounds typical of utopian ideology. Yes, any time you change the world you create risks, but you should not attempt to change the world cavalierly and blindly to those risks. (That's the path the National Program for Health IT in the United States has been on, until the IOM meeting was called.) Idealists tend to believe the collateral damage that is caused by utopian experiments (e.g., communism) are a necessary sacrifice to achieve the utopia. Such values are both abhorrent and alien to medicine.

“We want to make sure that implementation is as safe as it can be and all safety benefits are realized.”

Blumenthal's been painted into a corner by tons of complaints on HIT safety; ONC must act, even if just putting on a show about safety considerations. If there were true concern for safety he'd recommend slowing down HITECH timelines until the industry gets its act together and our understanding of HIT usability, safety, and other issues is resolved; cf.: statements of HIMSS leaders on 'needing to be patient' for the industry to get healthcare IT right:

As I'd written about HIMSS admissions of health IT unsuitability to task at "NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education":

... What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room".)

Further, from the NYT article:

He [Blumenthal] said that if the Institute of Medicine “concludes that regulation is an important part of this fabric of assuring safety, we will want to balance regulation and innovation as we do in every marketplace.”

That he even needs to make such a statement is likely revealing of biases on regulation, which seem aligned to the industry. To wit:

“The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future,” said Carl Dvorak, executive vice president of Epic Systems, which has built electronic records systems for Kaiser Permanente and other large health care and hospital groups.

There is a lack of evidence supporting such a statement (e.g., pharma has been regulated for decades, as is its clinical IT). The fact that NIST has just delivered Computer Science 101-level usability guidelines to the HIT industry in its recent report “NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records” to help solve the HIT unusability crisis also suggests that 30+ years of un-regulation did not facilitate ‘innovation.’

In fact 'unregulation' appears to have led to prima facie innovation failure and paralysis as far as usability is concerned.

Unusable health IT might as well not exist as far as clinicians are concerned. It is a menace to the safe practice of medicine. This is a first principle.

Per the NYT, the industry trade group HIMSS has gone mum:

The industry has recently avoided speaking out on a role for the F.D.A. In a statement for this article, the Healthcare Information and Management Systems Society, a Washington-based industry group, said only that it “supports the administration’s decision to ask the Institute of Medicine to study this complex issue and report back over the next 12 months.”

They are certainly not taking a leadership role on this issue. In my humble opinion they will allow regulation, only kicking and screaming and being dragged into it by force. Patients come second to profits - the only factor that will be "stifled" as vendors are coerced to make better products.

The NYT article goes on:

Last month, in protest of one common industry practice, the American Medical Informatics Association said “hold harmless” clauses in many purchasing contracts were unethical. The clauses typically absolve manufacturers of responsibility for any errors or misuse.

“We said we value innovation, but we don’t value it more than safety,” said Kenneth W. Goodman, a University of Miami bioethicist who headed an association advisory group on patient safety.

It took a lot of writing and politicking to get AMIA to this point as well, at least to express it openly (cf.: my efforts here).

Finally, with regard to the IOM meetings on HIT safety, there will be industry stakeholders in attendance such as CCHIT and EPIC.

I believe they should be held to scientific standards of delivery. If they deliver marketing-based spin, they should be called to present scientific evidence for their stance – and not just “positive” evidence. They should be made to refute “negative” evidence as well, not ignore it.

In summary, I welcome the New York Times bringing these issues to the public.

I also welcome IOM's entry into studying HIT safety. While a "Committee on Patient Safety and Health Information Technology" should have been convened years ago, it's better late than never. (Except for patients already injured or killed, of course.)

The results may remain as invisible as the aforementioned National Research Council study. I also doubt the Committee's findings will change hearts and minds. Idealism, profit motive, and irrational exuberance are hard to rectify.

But their effects on people's behaviors can - and should - be regulated.

-- SS

Addendum Dec. 17:

Healthcare Renewal blog to IOM: I have the information of the type you apparently seek on HIT-related injury. My Drexel Univ. site on HIT failures that's been around since 1999 comes up in the first few hits of Google searches on that subject, and has a banner at the top about my mother:

(click to enlarge, or go to site)

Anyone at IOM listening?

-- SS

New York Times: Panel Set to Study Safety of Electronic Patient Data

New York Times author Milt Freudenheim has published an interesting article on health IT:

"Panel Set to Study Safety of Electronic Patient Data" (Dec. 13, 2010, link)

In the article Mr. Freudenheim presents various viewpoints on health IT safety and usability, and reports on an upcoming Institute of Medicine (IOM) Committee on Healthcare IT safety.

In general, the expressed viewpoints reported upon are consistent with the position in the Healthcare IT Ecosystem of those quoted. I wish to add some commentary to a number of those stated positions.

Mr. Freudenheim observes:

Taking a fresh look at such concerns, the Institute of Medicine created the Committee on Patient Safety and Health Information Technology to run a yearlong study and issue recommendations. The 16-member panel is meeting for the first time on Tuesday in Washington.

(This new IOM Committee is in addition to a 2009 study by the National Academies/National Research Council that concluded that "Current Approaches to U.S. Health Care Information Technology are Insufficient", which has largely been invisible. The IOM is the health arm of the National Academies.)

I would add that this Committee is at least a decade late. That it is occurring at all seems to be at the behest of a multitude of complaints and "blows of the whistle" from clinicians who increasingly depend (either voluntarily or by coercion) on this technology to provide safe care.

I would also add that it is my hope the IOM committee with not be overly politicized, considering the stated unconditional exuberance of the past two administrations towards health IT, and that a wide variety of stakeholders will be heard. (For instance, as a medical informatics specialist whose mother was injured as a result of HIT interference with clinician communications, will I be allowed to testify?)

Mr. Freudenheim then relates the points of view of stakeholders.

In February, the F.D.A. said it had received 260 reports of malfunctions related to health information technology “with the potential for patient harm,” including 44 reported injuries and six reported deaths in 2008 and 2009. The malfunctions were reported voluntarily to the agency, mainly by hospitals.

“Because these reports are purely voluntary, they may represent only the tip of the iceberg,” said Dr. Jeffrey Shuren, a senior F.D.A. policy and enforcement official.

I'd written about this at "FDA on Health IT Adverse Consequences: 44 Reported Injuries and 6 Deaths, Probably Just Tip of Iceberg" where I noted:

This is a technology almost universally touted as inherently beneficial, right up to our most senior elected leaders, who are now pushing this unproven technology under threat of penalty for non-adopters.

Healthcare IT irrational exuberance can perhaps be illustrated in statements such as this:

“We have the capacity to transform health with one thunderous click of a mouse after another,” said (former) HHS Secretary Michael Leavitt - 2005 HIMSS Summit

I also opined at "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers" that one could, as a type of thought experiment, extrapolate from these numbers to guesstimate the effects of universal health IT in the US. The results were startling, even if just an experiment:

[We might have] 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved ... While this is a mere thought experiment, the result certainly suggests we need to know the actual rates of HIT-related patient harm, and act to understand and minimize these events.

In setting national healthcare policy, we should not rely on thought experiments - but even more importantly, we should not be relying on guesswork and wishful thinking as we are currently.

Unfortunately, national policy has been set up to now on wishful thinking. As I stated, the IOM meeting is coming none too soon.

The NYT article then reports on a statement made by ONC Chair David Blumenthal:

“All options for assuring safety are on the table,” said Dr. David Blumenthal, the Obama administration’s national coordinator for health information technology.

Yet Dr. Blumenthal is clearly an adherent to unbridled exuberance about health IT. At "Science or Politics? The New England Journal and the 'Meaningful Use' Regulation for Electronic Health Records" I wrote:

... In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

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.

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.

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.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. [Followed by a list of such literature just off the top of my head - ed.]

Dr. Blumenthal then appeals to authority:

Dr. Blumenthal said health information experts like Dr. Donald M. Berwick, the Medicare and Medicaid administrator, and Dr. Brent James, of Intermountain Healthcare, based in Salt Lake City, “agree that electronic health records will improve the safety of care.”

I am unaware of the expertise of Dr. Berwick and Dr. James in this domain, and the peer reviewed literature they've written that supports such a statement while soundly refuting literature written by other experts that indicates otherwise.

(Perhaps at Intermountain, custom systems that took decades to develop utilizing their Medical Informatics expertise do show safety gains, but such systems and the lessons learned building them are not easily portable to a country's worth of organizations and practitioners, especially under HITECH timeframes.)

Freudenheim then quotes Blumenthal as stating:

“At the same time, any time you change the world you create risks,” Dr. Blumenthal said in a telephone interview last weekend.

This sounds typical of utopian ideology. Yes, any time you change the world you create risks, but you should not attempt to change the world cavalierly and blindly to those risks. (That's the path the National Program for Health IT in the United States has been on, until the IOM meeting was called.) Idealists tend to believe the collateral damage that is caused by utopian experiments (e.g., communism) are a necessary sacrifice to achieve the utopia. Such values are both abhorrent and alien to medicine.

“We want to make sure that implementation is as safe as it can be and all safety benefits are realized.”

Blumenthal's been painted into a corner by tons of complaints on HIT safety; ONC must act, even if just putting on a show about safety considerations. If there were true concern for safety he'd recommend slowing down HITECH timelines until the industry gets its act together and our understanding of HIT usability, safety, and other issues is resolved; cf.: statements of HIMSS leaders on 'needing to be patient' for the industry to get healthcare IT right:

As I'd written about HIMSS admissions of health IT unsuitability to task at "NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education":

... What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room".)

Further, from the NYT article:

He [Blumenthal] said that if the Institute of Medicine “concludes that regulation is an important part of this fabric of assuring safety, we will want to balance regulation and innovation as we do in every marketplace.”

That he even needs to make such a statement is likely revealing of biases on regulation, which seem aligned to the industry. To wit:

“The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future,” said Carl Dvorak, executive vice president of Epic Systems, which has built electronic records systems for Kaiser Permanente and other large health care and hospital groups.

There is a lack of evidence supporting such a statement (e.g., pharma has been regulated for decades, as is its clinical IT). The fact that NIST has just delivered Computer Science 101-level usability guidelines to the HIT industry in its recent report “NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records” to help solve the HIT unusability crisis also suggests that 30+ years of un-regulation did not facilitate ‘innovation.’

In fact 'unregulation' appears to have led to prima facie innovation failure and paralysis as far as usability is concerned.

Unusable health IT might as well not exist as far as clinicians are concerned. It is a menace to the safe practice of medicine. This is a first principle.

Per the NYT, the industry trade group HIMSS has gone mum:

The industry has recently avoided speaking out on a role for the F.D.A. In a statement for this article, the Healthcare Information and Management Systems Society, a Washington-based industry group, said only that it “supports the administration’s decision to ask the Institute of Medicine to study this complex issue and report back over the next 12 months.”

They are certainly not taking a leadership role on this issue. In my humble opinion they will allow regulation, only kicking and screaming and being dragged into it by force. Patients come second to profits - the only factor that will be "stifled" as vendors are coerced to make better products.

The NYT article goes on:

Last month, in protest of one common industry practice, the American Medical Informatics Association said “hold harmless” clauses in many purchasing contracts were unethical. The clauses typically absolve manufacturers of responsibility for any errors or misuse.

“We said we value innovation, but we don’t value it more than safety,” said Kenneth W. Goodman, a University of Miami bioethicist who headed an association advisory group on patient safety.

It took a lot of writing and politicking to get AMIA to this point as well, at least to express it openly (cf.: my efforts here).

Finally, with regard to the IOM meetings on HIT safety, there will be industry stakeholders in attendance such as CCHIT and EPIC.

I believe they should be held to scientific standards of delivery. If they deliver marketing-based spin, they should be called to present scientific evidence for their stance – and not just “positive” evidence. They should be made to refute “negative” evidence as well, not ignore it.

In summary, I welcome the New York Times bringing these issues to the public.

I also welcome IOM's entry into studying HIT safety. While a "Committee on Patient Safety and Health Information Technology" should have been convened years ago, it's better late than never. (Except for patients already injured or killed, of course.)

The results may remain as invisible as the aforementioned National Research Council study. I also doubt the Committee's findings will change hearts and minds. Idealism, profit motive, and irrational exuberance are hard to rectify.

But their effects on people's behaviors can - and should - be regulated.

-- SS

Addendum Dec. 17:

Healthcare Renewal blog to IOM: I have the information of the type you apparently seek on HIT-related injury. My Drexel Univ. site on HIT failures that's been around since 1999 comes up in the first few hits of Google searches on that subject, and has a banner at the top about my mother:

(click to enlarge, or go to site)

Anyone at IOM listening?

-- SS

ECRI: Healthcare IT In Top Ten Health Technology Threats to Patient Safety

Number 5, that is.

The ECRI Institute is an independent, unbiased, evidence-based healthcare research, information, and advice provider. They have been in operation for more than 40 years and are one of only a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-Based Practice Center by the U.S. Agency for Healthcare Research and Quality.

I've cited their code of ethics at HC Renewal as a model of commendable healthcare conduct before:

Conflict of Interest - The Integrity of Independence

Remaining unbiased is difficult, if not impossible, when conflicts of interest are present. That is why we strictly enforce our conflict-of-interest rules and have carefully developed an environment that maximizes objectivity, productivity, and integrity of process.

We accept no grants, gifts, finder’s fees, or consulting projects from, and our employees are not permitted to own stock shares in, medical device or pharmaceutical firms. To make sure that is the case, we examine each employee’s federal income tax return after it is filed.

And, we accept no advertising revenues from any source.

(Full disclosure: I was a contributor on health IT issues to their 2008 book "Physician Office Fundamentals in Risk Management and Patient Safety.")

ECRI's most recent report is "The Top Ten Health Technology Threats to Patient Safety" for 2011 available at this link. Their Dec. 7 press announcement is here.

I'd mentioned an earlier edition of the report at my Sept 2010 post "Health IT: Danger" as was spoken about by Dr. Ross Koppel at Univ. of PA, but will present more detail here now that the 2011 report is available to the public.

I am citing the WSJ health blog on this report, as ECRI requests linking to their registration and downloading page for the full report, rather than direct dissemination, posting, or republishing of this work, without prior written permission:

December 8, 2010, 6:15 PM ET
The Top Ten Health Technology Threats to Patient Safety
WSJ Health Blog

By Katherine Hobson

For the fourth year running, the nonprofit ECRI Institute has put together a list of what it judges to be the top ten health technology hazards on which health-care facilities should focus their efforts.

The list in descending order of importance, doesn’t necessarily reflect the devices or problems with the most reported errors. That’s a factor, but so is “the severity of the problem, whether or not there’s a way to fix or mitigate the problem, and the high-profile” nature of the problem, Jim Keller, vice president for health technology evaluation and safety at ECRI, tells the Health Blog.

Among risks such as radiation therapy overdose and other dosing errors (#1), alarm hazards (#2), cross-contamination from flexible endoscopes (#3), high radiation dose of CT scans (#4), and luer misconnections (#6, misconnections of various infusion tubes), there's this:

#5 Data loss, system incompatibilities and other health IT complications: Problems with electronic-health records and other health IT systems can lead to problems including lost data, the need for repeat testing and even patient injury or death.

Then another obvious concern is raised:

While Keller says both he and ECRI support the push for digitized systems, the rush for federal incentives raises “concern that some of the kind of problems we are describing will be overlooked.”

It's not a "concern" to me, it's a fact.

So, here we have it:

An independent, nonprofit organization that for more than 40 years has been dedicated to bringing the discipline of applied scientific research to discover which medical procedures, devices, drugs, and processes are best, with unique ability to marry practical experience and uncompromising independence with the thoroughness and objectivity of evidence-based research, reports:

"Problems with electronic-health records and other health IT systems can lead to problems including lost data, the need for repeat testing and even patient injury or death."

The degree of risk is unknown (cf.: Joint Commission 2009 Sentinel Event Alert on Health IT Safety, PDF):

"There is a dearth of data on the incidence of adverse events directly caused by HIT overall."

This does not seem the best environment for the ethical, rapid diffusion of this technology nationwide, under penalty of loss of income and loss of Board Certification and even licensure for non-adopters.

For those of different ethics than ECRI, health IT is a literal cornucopia.

Addendum:

I note this comment from a nurse at the WSJ health blog story's comment section:

8:50 am December 9, 2010

The list was predictable, emanating from my observations as a registered nurse. It has become impossible to give patients care that they need. Corners are cut. It is easier for doctors to order scans than it is to examine patients. I would rather examine patients but the hospital requires that I click everything in to the electronic record, and [t]hat takes a long time. The reference to the CPOE is true. It is a nightmare because of the mistakes it promotes and it intereferes with communication disrupting my team’s care of the patient.

This must be one of those "anecdotal" reports that constitute a growing corpus of irrelevant "anecdotes", to be safely ignored because they were not obtained as part of a scientific experiment.

-- SS

Addendum Dec. 10, 2010:

From an earlier post of mine (of which I was reminded via a viewing from IP 150.148.0.#, FDA.gov, on a Google search on "health IT safety" this morning), we don't need to worry about HIT risks. ONC chair David Blumenthal said so:

... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said.

-- SS

ECRI: Healthcare IT In Top Ten Health Technology Threats to Patient Safety

Number 5, that is.

The ECRI Institute is an independent, unbiased, evidence-based healthcare research, information, and advice provider. They have been in operation for more than 40 years and are one of only a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-Based Practice Center by the U.S. Agency for Healthcare Research and Quality.

I've cited their code of ethics at HC Renewal as a model of commendable healthcare conduct before:

Conflict of Interest - The Integrity of Independence

Remaining unbiased is difficult, if not impossible, when conflicts of interest are present. That is why we strictly enforce our conflict-of-interest rules and have carefully developed an environment that maximizes objectivity, productivity, and integrity of process.

We accept no grants, gifts, finder’s fees, or consulting projects from, and our employees are not permitted to own stock shares in, medical device or pharmaceutical firms. To make sure that is the case, we examine each employee’s federal income tax return after it is filed.

And, we accept no advertising revenues from any source.

(Full disclosure: I was a contributor on health IT issues to their 2008 book "Physician Office Fundamentals in Risk Management and Patient Safety.")

ECRI's most recent report is "The Top Ten Health Technology Threats to Patient Safety" for 2011 available at this link. Their Dec. 7 press announcement is here.

I'd mentioned an earlier edition of the report at my Sept 2010 post "Health IT: Danger" as was spoken about by Dr. Ross Koppel at Univ. of PA, but will present more detail here now that the 2011 report is available to the public.

I am citing the WSJ health blog on this report, as ECRI requests linking to their registration and downloading page for the full report, rather than direct dissemination, posting, or republishing of this work, without prior written permission:

December 8, 2010, 6:15 PM ET
The Top Ten Health Technology Threats to Patient Safety
WSJ Health Blog

By Katherine Hobson

For the fourth year running, the nonprofit ECRI Institute has put together a list of what it judges to be the top ten health technology hazards on which health-care facilities should focus their efforts.

The list in descending order of importance, doesn’t necessarily reflect the devices or problems with the most reported errors. That’s a factor, but so is “the severity of the problem, whether or not there’s a way to fix or mitigate the problem, and the high-profile” nature of the problem, Jim Keller, vice president for health technology evaluation and safety at ECRI, tells the Health Blog.

Among risks such as radiation therapy overdose and other dosing errors (#1), alarm hazards (#2), cross-contamination from flexible endoscopes (#3), high radiation dose of CT scans (#4), and luer misconnections (#6, misconnections of various infusion tubes), there's this:

#5 Data loss, system incompatibilities and other health IT complications: Problems with electronic-health records and other health IT systems can lead to problems including lost data, the need for repeat testing and even patient injury or death.

Then another obvious concern is raised:

While Keller says both he and ECRI support the push for digitized systems, the rush for federal incentives raises “concern that some of the kind of problems we are describing will be overlooked.”

It's not a "concern" to me, it's a fact.

So, here we have it:

An independent, nonprofit organization that for more than 40 years has been dedicated to bringing the discipline of applied scientific research to discover which medical procedures, devices, drugs, and processes are best, with unique ability to marry practical experience and uncompromising independence with the thoroughness and objectivity of evidence-based research, reports:

"Problems with electronic-health records and other health IT systems can lead to problems including lost data, the need for repeat testing and even patient injury or death."

The degree of risk is unknown (cf.: Joint Commission 2009 Sentinel Event Alert on Health IT Safety, PDF):

"There is a dearth of data on the incidence of adverse events directly caused by HIT overall."

This does not seem the best environment for the ethical, rapid diffusion of this technology nationwide, under penalty of loss of income and loss of Board Certification and even licensure for non-adopters.

For those of different ethics than ECRI, health IT is a literal cornucopia.

Addendum:

I note this comment from a nurse at the WSJ health blog story's comment section:

8:50 am December 9, 2010

The list was predictable, emanating from my observations as a registered nurse. It has become impossible to give patients care that they need. Corners are cut. It is easier for doctors to order scans than it is to examine patients. I would rather examine patients but the hospital requires that I click everything in to the electronic record, and [t]hat takes a long time. The reference to the CPOE is true. It is a nightmare because of the mistakes it promotes and it intereferes with communication disrupting my team’s care of the patient.

This must be one of those "anecdotal" reports that constitute a growing corpus of irrelevant "anecdotes", to be safely ignored because they were not obtained as part of a scientific experiment.

-- SS

Addendum Dec. 10, 2010:

From an earlier post of mine (of which I was reminded via a viewing from IP 150.148.0.#, FDA.gov, on a Google search on "health IT safety" this morning), we don't need to worry about HIT risks. ONC chair David Blumenthal said so:

... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said.

-- SS

EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

Additional detailed answers to the questions I raised here and here about a new site EHRevent.org, for reporting of healthcare IT-related medical errors, can now be found at a HIStalk interview entitled "HIStalk Interviews Edward Fotsch MD, CEO, PDR Network (EHR Event)" at this link.

It is an interesting interview. I certainly find the recognition of need for an EHR/clinical IT problems reporting service a major cultural advancement in healthcare.

It's still unclear to me how -- and why -- this organization originated with little to no public knowledge and involvement, especially considering the organization types mentioned below that participated, and how it will function in interactions with myriad healthcare IT stakeholders.

Here's an explanation by Dr. Fotsch:

... We work with a not-for-profit board called the iHealth Alliance. They Alliance is made up of medical society executives, professional liability carriers, and liaison representatives from the FDA. They govern some of the networks that we run, and in exchange for that, help us recruit physicians. Professional liability carriers, for example, promote our services that send drug alerts to doctors because that’s good and protective from a liability standpoint.

In the course of our conversations with them roughly a year ago, when we were talking about adding some drug safety information into electronic health records, we came across the fact that there were concerns from the liability carriers that there was no central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records.

[Translation: the carriers saw their losses potentially increasing as a result of litigation arising from EHR-related lawsuits, and decided to do something proactive- ed.]

They were interested in creating a single place where they could promote to their insured physicians that they could report adverse EHR events. Then it turned out that medical societies had similar concerns.

[That must have been one of the best-kept secrets on Earth considering the promotion EHR's have received as a miracle-working technology, and the lack of expression of concerns from those societies - ed.]

Rather than have each of them create a system, the Alliance took on a role of orchestrating all of the interests, including some interest from the FDA and ONC in creating an electronic health record problem reporting system. That’s how it came into play.

Our role in it, in addition to having a seat on the iHealth Alliance board, was really in network operations — in running the servers, if you will, which didn’t seem like a very complicated task. Since business partners we rely on for our core business were interested in it, it was easy to say yes. It frankly turned out to be somewhat more complicated than we originally thought [I predict they haven't seen anything yet; wait until they get knee deep into real world EHR issues - ed.], but now it’s up and available.

While I find the recognition of need for an EHR/clinical IT reporting service a major advancement, I am nonetheless troubled by certain statements made by Dr. Fotsch. They seem at odds with the theoretic and empirical findings of medical informatics, social informatics, human-computer interaction and other fields relevant for health IT evaluation, and/or seem to demonstrate biases about HIT. My comments are in red italics:

Fotsch:

… Probably what we’re seeing more often than not, the real challenge with EHRs like any technology, turns out to be some form of user error.

[What about contributory or causative designer error? – ed.]

“I didn’t know it would do that"

[Why did the user not know? Lack of training, poor manuals, or overly complex information systems lacking informative messages and consistency of control-action relationships, as an example? -ed]

... or “I didn’t know that it pre-populated that"

[Why did it pre-populate? Was that inappropriate for the clinical context, such as in this example?]

... or “I didn’t know I shouldn’t cut and paste"

[Then why did the software designers enable cut and paste, without some informative message on overuse, such as length of text cut and pasted?– ed.]

... or “I wasn’t paying attention to this"

[Perhaps due to distractions from mission hostile user interfaces? -ed]

... or maybe the user interface was a little confusing

[What is "a little confusing?" (Is that like "A little pregnant?) And why was it confusing? User intellectual inadequacy, or software design issues leading to cognitive overload? - ed.]

Actual software errors appear to be the exception rather than the rule as it relates to EHR events.

["Actual software errors" are defined as, what, exactly--? Loss of database relational integrity as a result of a programming error, as apparently recently happened at Trinity Health, a large Catholic hospital chain as reported in HIStalk? Memory leaks from poor code? Buffer overflows? What?]

That’s at least as I understand it.

[Understand it from whom? Hopefully not from me or my extensive website on the issues, the site whose header sadly now appears as below - ed.]

A new, unfortunate header for my website on health IT failures. Click to enlarge the shaded area, or click here to go to the site.

In summary, a "blame the user" attitude seems apparent. There appears to be little acknowledgment of the concept of IT "errorgenicity" - the capacity of a badly designed or poorly implemented information system to facilitate error, and of the systemic nature of errors in complex organizations to which ill-done IT can contribute.

These are concepts understood long ago in mission critical settings, as in this mid 1980's piece from the Air Force cited in my previously-linked eight part series on mission hostile health IT:

From "GUIDELINES FOR DESIGNING USER INTERFACE SOFTWARE"
ESD-TR-86-278
August 1986
Sidney L. Smith and Jane N. Mosier
The MITRE Corporation
Prepared for Deputy Commander for Development Plans and Support Systems, Electronic Systems Division, AFSC, United States Air Force, Hanscom Air Force Base, Massachusetts.

... SIGNIFICANCE OF THE USER INTERFACE

The design of user interface software is not only expensive and time-consuming, but it is also critical for effective system performance. To be sure, users can sometimes compensate for poor design with extra effort. Probably no single user interface design flaw, in itself, will cause system failure. But there is a limit to how well users can adapt to a poorly designed interface. As one deficiency is added to another, the cumulative negative effects may eventually result in system failure, poor performance, and/or user complaints.

Outright system failure can be seen in systems that are underused, where use is optional, or are abandoned entirely. There may be retention of (or reversion to) manual data handling procedures, with little use of automated capabilities. When a system fails in this way, the result is disrupted operation, wasted time, effort and money, and failure to achieve the potential benefits of automated information handling.

In a constrained environment, such as that of many military and commercial information systems, users may have little choice but to make do with whatever interface design is provided. There the symptoms of poor user interface design may appear in degraded performance. Frequent and/or serious errors in data handling may result from confusing user interface design [in medicine, this often translates to reduced safety and reduced care quality - ed.] Tedious user procedures may slow data processing, resulting in longer queues at the checkout counter, the teller's window, the visa office, the truck dock, [the hospital floor or doctor's office - ed.] or any other workplace where the potential benefits of computer support are outweighed by an unintended increase in human effort.

In situations where degradation in system performance is not so easily measured, symptoms of poor user interface design may appear as user complaints. The system may be described as hard to learn, or clumsy, tiring and slow to use [often heard in medicine, but too often blamed on "physician resistance" - ed.] The users' view of a system is conditioned chiefly by experience with its interface. If the user interface is unsatisfactory, the users' view of the system will be negative regardless of any niceties of internal computer processing.

I am not entirely happy when the CEO of an organization taking on the responsibility of being a central focus for EHR error reporting makes statements that are consistent with unfamiliarity with important HIT-relevant domains, as well as a possible pro-IT, anti-user biases.

For that reason as well as the other questions raised at my prior posts (such as the onerous legal contract and apparent lack of ability of the public to easily view the actual report texts themselves), I cannot recommend use of their site for EHR problems reporting.

I recommend the continued use of the FDA facilities until such time as a compelling argument exists to do otherwise.

-- SS

Addendum 11/28/10:

This passage ends the main essay at my site "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" and is quite relevant here:

... An article worth reviewing is "Human error: models and management", James Reason (a fitting name!), BMJ 2000;320:768-770 (18 March), http://www.bmj.com/cgi/content/full/320/7237/768:

Summary points:

• Two approaches to the problem of human fallibility exist: the person and the system approaches
  

• The person approach focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness

• The system approach concentrates on the conditions under which individuals work and tries to build defenses to avert errors or mitigate their effects

• High reliability organizations---which have less than their fair share of accidents---recognize that human variability is a force to harness in averting errors, but they work hard to focus that variability and are constantly preoccupied with the possibility of failure.

-- SS