Showing posts with label Jon Patrick. Show all posts
Showing posts with label Jon Patrick. Show all posts

Tuesday, March 8, 2011

The Future Pathways for e-Health in NSW

Prof. Patrick has now added a new section to his report on health IT in NSW Australia, 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, lack of transparency, suppression of defects reporting, magical thinking about the technology, and lack of accountability of the bureaucrats).

Emphases mine:

In Short Term ( 0-3 months)

1. Halt further rollouts of Firstnet or other CIS systems. The current roll-out programs use significant efforts in training staff for a system that is counterproductive to patient well being.
2. Complete a full and thorough risk assessment analysis and usability of the software. The CIS report indicates there are a number of risks in the current software that are not likely to have been assessed in the past.
3. Address the current problems before doing anything else. There are a number of problems that appear solvable in the short term that would improve the situation for current users, such as providing needed reports.
4. Create the NSW IT Improvement Panel composed of ED Directors, IT-savvy clinical and quality improvement staff responsible for advising on the preparedness and process of the rollout.
5. Create an effective error and bug reporting mechanism that is viewable by all ED directors and with the display of the priority of each entry and expected completion time.
6. Initiate a high profile campaign to encourage staff to lodge fault records on anything they discover wrong, problematic or inefficient in using the system.

In the longer term (3-12 months)

1. Review the Health Support Services and make it clinically accountable by appointing a clinical head with an IT education.
2. Create a culture change in the HSS. The current operation of the HSS seems to be devoid of influence from the clinical community.
3. All NSW CIS system procurement should be guided by an IT Advisory Board of IT experienced clinical, academic and medical software industry experts.
4. Create pathways for hospitals that wish to be early adopters and take a lead role in the development of new methods for using and deploying IT systems.
5. Support innovation within the Australian medical software communities that contribute to a culture of innovation and continuous quality improvement.
6. Adopt transparency rules in all new healthcare information acquisitions. Secrecy has bedevilled the efforts of staff and management to get improvements in the CIS systems and hold service agents accountable for their failure to comply to service level agreements. All agreements about a signed contract should be available to the ED Directors.
7. Replace the State Based Build policy with a policy of providing a technology to match the technology experience of the individual departments so that leaders are not dragged backwards with inappropriate technology installation

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

I can only add that our own ONC office (Office of the National Coordinator for Health IT of the Dept. of HHS) had more granular recommendations about expertise levels required for leadership roles in such undertakings. I wrote about them at my Dec. 2009 post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership."

--SS

Monday, March 7, 2011

Are Those Sockpuppers From Down Under?

We at Healthcare Renewal have had experience with the healthcare sock puppets. They are shills, a person or group working on behalf of a company or other special interest. They attempt to use distraction, ad hominem, misdirection and other psyops tactics to attack points of view they don't like. They also plant memes they or their sponsor deem desirable.

They are universally anonymous in their postings.

One got careless and got nailed via IP forensics, as at my Jan. 2010 post "More on Perversity in the Healthcare IT World: Is Meditech Employing Sockpuppets?" and my semi-satirical followup post a few days later, "Socky the Meditech Sockpuppet on Vacation?" after he/she disappeared after exposure.

A Healthcare Renewal reader with an MBA at that time non-anonymously related the following (emphases mine):

In reading this thread of comments I have to believe IT Guy [the Sock puppet - ed.] is a salesperson. My only question is: Were you assigned this blog or did you choose it? We had this problem a number of years ago where a salesperson was assigned a number of blogs with the intent of using up valuable time in trying to discredit the postings.

In my very first sales class we learned to focus on irrelevant points, constantly shift the discussion, and generally try to distract criticism. I would say that HCR is creating heat for IT Guy’s employer and the industry in general.

I find it sad that a company would allow an employee to attack anyone in an open forum. IT Guy needs to check with his superiors to find out if they approve of this use of his time, and I hope he is not using a company computer, unless once again this attack is company sanctioned.

Steve Lucas

It seems this foul type of creature is starting to crawl out of the woodwork regarding Prof. Jon Patricks' analysis of an ED EHR system mandated by the state's government of NSW for public hospitals, as I wrote about in my posts such as on Mar. 5, 2011 at "On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts.".

They may be corporate, they may be government. They likely have a financial stake in the ED EHR project as well.

For instance, the sockpuppet/shill comments are starting to appear at the Australian Health Information Technology blog of Dr David More MB, PhD, FACHI at http://aushealthit.blogspot.com:

This blog has only three major objectives.

The first is to inform readers of news and happenings in the e-Health domain, both here in Australia and world-wide.

The second is to provide commentary on what seems to have become the lamentable state of e-Health in Australia and to foster improvement.

The third, sadly, is now to try and force accountability for the actions of, and the funds spent, by NEHTA. [
National E-Health Transition Authority as at this link - ed.]

(Sounds like a kindred mission relative to HC Renewal.)

For instance at Dr. More's post "Prof Patrick Has Really Hit the Bullseye It Would Seem. Lots of Supportive Comments From All Over!" we see the following sock puppet-like comments rearing their holey (not holy) woven head:

... It seems that the heuristic axiom of Ockham’s Razor (as presented by Jon) is the design criteria by which Jon thinks NSW Health should have selected their CIS ... unbelievable!

Unfortunately Jon has not proposed any practical alternatives in his papers. His papers are full of opinions, unfounded claims and incorrect facts (not to mention the countless flaws in his research methodologies).

and

Dr Patrick - you are so misinformed. There are so many untruths in what you report. Why is this? Because you interviewed 7 people. Being Directors, what is the likelihood they are hands on with the system? Minimal I would say from experience in the EDs. Call yourself a researcher - huh! It is a totally biased report which reflects the opinions of those with an axe to grind. Why don't you talk to some nurses,clerical staff and junior doctors? There are hundreds of them working in EDs across the state. Their opinion should matter as they are the ones caring for our patients. You should be ashamed of yourself! I certainly would not hire you to do a research project if this is the biased and blatantly incorrect rubbish that you come up with. Shame on you!!

and the ever-so-common refrain of:

Has Dr Patrick ever completed (or even been involved in) an implementation of an EMR (at all or of any scale)? Can someone tell us what makes him an authority the subject? [I, OTOH, have done so, authoring, implementing, managing for hospitals and major pharma - ed.]

... His view is unbalanced and his paper is clearly bias. How Sydney University tolerates papers of such poor quality and biasness (being published by their professors) is beyond me. [Paper is 'clearly bias'? Biasness? This person needs a grammar lesson - ed.]

Ink is never put to specifics of the supposed transgressions in these largely ad hominem, anonymous attacks.

If those who wrote them had the fortitude to identify themselves, perhaps they might be somewhat credible. However that rarely if ever is the case.

In my humble opinion, such comments are risible, not even worth the electrons they're written with.

Except for amusement:

Socky the Health IT Sockpuppet. Click to enlarge.

p.s. an ED EHR-injured relative of mine has a message to the sockpuppets of the world. It's not fit for a public site, but it has to do with travel to a very hot, deep, sulfurous place in the earth.

-- SS

EHR ED's in New South Wales. Will the Problems Magically "Disappear?"

It occurs that one could look at Prof. Jon Patrick's recent health IT forensic analysis as a kind of "indictment" of the industry.

He can be seen as suggesting the industry needs to be "put on trial" (figuratively) regarding "crimes" (again, figuratively speaking) they've committed with regard to IT robustness and reliability. The latter translate directly to patient safety.

In a lawsuit such as a medical malpractice trial, obvious as well as potential evidence is put under "legal hold." For instance, if an EHR defect is suspected, metadata, audit trails, and patient data are asked (or should be asked) to be frozen or archived in the state they were in at the time of the alleged accident.

It can take a page or three (or more) of specifications simply to define what information, exactly, needs to be put on legal hold. My former staff were frequently required to place myriad materials on legal hold at Merck Research Labs, for example, baed on the lawsuit du jour.

Once frozen, discovery and forensic analysis of these now-static data can then proceed. In fact, cases can be lost on the basis of evidence of an archiving omissions, destruction or tampering when information holds are requested.

It occurs to me that Prof. Patrick has given the industry a detailed look into factors they could start to remediate, without publicity and without telling anyone. While this would be a net plus for patients, it might result in less of a learning experience to the industy than that industry needs, to motivate the industry to avoid future product engineering and quality issues and put quality (not simply margin) as priority #1.

I therefore would believe a "hold" put on the present state of these ED EMR systems, or a "snapshot" of their current state (i.e., an evaluation environment mirrored from the present operational one) would allow a careful evaluation of the impact of the issues noted in the study.

Such an evaluation would be far more difficult with a cybernetic moving target.

The "snapshot" idea would allow evaluation of system risk levels, intermittent "glitches", interference with workflows, etc. in a controlled testing environment, using mock data or data drawn from actual cases.

The "snapshot" approach would also allow incremental remediation of the "live" system that comes out of safe, controlled testing, rather than sticking with what exists now until the studies could be completed on the as-is system, and then applying all the fixes as one or more large "upgrades."

I, for one, would be interested in studying this "built by software professionals" system and comparing it to health IT systems we "academic nerds" were authoring, say, 10-15 years ago.

-- SS

Australian ED EHR Study: An End to the Line "Your Evidence Is Anecdotal, Thus Worthless?"

At my Sept. 2010 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" I lamented that while my early mentor in biomedicine Victor P. Satinsky MD taught the wise credo "critical thinking always, or your patient's dead" in the 1970's, our culture had become so perverse that this credo had been largely supplanted with:



"Critical thinking anytime, and your career's dead."



That post was in reaction to continued heckling on a professional mailing list, the American Medical Informatics Association (AMIA) Clinical Information Systems Working Group (cis-wg). On this list, Oregon Health Sciences University professor William Hersh expounded on how the evidence of health IT dangers was largely "anecdotal" therefore to be discounted, and how I, specifically, "didn't know the literature on health IT."



In that post I put the lie to the latter figment. On the former prevarication Dr. Jon Patrick, author of the recent thorough dissection of problems with the ED EHR system being rolled out in public hospitals in New South Wales, Australia (see my Mar. 5, 2011 post "On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts"), hit the ball out of the park:



Prof. Patrick to AMIA cis-wg:



I think such defences are particularly unuseful especially with respect to the dismissal of personal stories and experiences as "anecdotes", hence committing them to the realm of folklore. I offer these notions as a counterpoint.



Discounting Anecdotes:



1. Is a perfidious and specious act.



2. It denies early warning signs of problems.



3. It denies a voice and disempowers the working clinical community who have to operationalise decisions made by others.



4. It denies a route to process improvement within an institution - which is most important for EBM and incremental review of local processes.



5. It defends software manufacturers from fault rectification - cuts off even a need to deliberate on it. Critics of the value of anecdotes are squarely on the side of the faulty and deficient manufacturer.



6. A rule of project management is that projects consist of 3 components, cost, quality and time and if their needs to be a compromise it has to be on quality. Anecdotes are early warning signs of such a compromise.



Prof. Patrick had to once again put the lie to this refrain at a comment on the HISTalk blog yesterday, where the anonymous proprietor had written in a review of Patrick's EHR study:



... On the other hand, I wouldn’t say it’s [Prof. Patrick's Cerner FirstNet study] necessarily unbiased, it focuses on implementation of a single department application that didn’t go well for a variety of reasons (despite many successful FirstNet implementations elsewhere), it uses the unchallenged anecdotal comments of unhappy users who make it clear they liked their previous EDIS better, and it nitpicks (I wasn’t moved to find a pitchfork when I learned that the primary keys in the Millennium database aren’t named consistently).



[Considering the complexity and changeability of healthcare and the corresponding software lifecycle, I duly note that that latter attitude about 'failing to find pitchforks' regarding breaches of sound software engineering practices seems to be a symptom of the larger health IT disease that Prof. Patrick writes about - ed.]


Dr. Patrick then knocked the ball out of the Southern Hemisphere with a comment of his own about anecdotalism and a link to an expansion of the aforementioned ideas he'd shared on "discounting anecdotes":



Prof. Patrick to HISTalk owner:



Your Comment “it uses the unchallenged anecdotal comments of unhappy users ” is not only unfair but unreasonably inaccurate. The comments made by the users are the Directors of 7 EDs and so they have a right to carry authority by virtue of the experience but also the number of 6 out 7 presenting a view of Firstnet as unfit for purpose has numeric validity, which they justify with about 20+ pages of their comments – see Part 2 Appendix 2.



I would also point readers to my editorial about the role of personal experiences being the most useful information to understand the nature of socio-technical failures. http://aci.schattauer.de/en/contents/archive/issue/1124/manuscript/15463/show.html


The essay at that link, "The Validity of Personal Experiences in Evaluating HIT", is an editorial in Johns Hopkins informaticist Chris Lehmann's brilliant new journal "Applied Clinical Informatics."



The editorial is available free, and is a must-read for anyone in a decision-making or managerial role in mission critical domains, including our elected representatives.



In the editorial Dr. Patrick concludes. similarly to his earlier AMIA mailing list opinion:



... the denial of recounted personal experiences in discussion and analysis of HIT is biased and specious and has the effect of:



1. Denying early warning signs of problems.



2. Denying a voice for the working clinical community who have to operationalise decisions made by others and thus disempowers them.



3. Denying process improvement within an institution – which is most important for Evidence Based Medicine and incremental review of local processes.



4. Discourages staff from engaging in any form of process improvement hence worsening the sense of disenchantment.



Every legitimate personal experience of a HIT deserves to be considered on its merits lest we wish to retreat from process and product improvement. Mechanisms of censorship both implicit due to contrived processes of disinformation and disempowerment or explicit due to contractual specifications will lead to more waste, lost productivity, contempt for the providers, and distress among frontline staff rather than increased productivity and improved patient health and safety as we all desire.



In my view, the drivers or motivators for the "anecdotalist" accusation are these, singly or in combination:



  • Too much "education" to see the nose on one's face, as in, to think zebras and unicorns instead of horses when hearing hoofbeats outside one's midwest U.S. abode (eggheads);

  • Too little common sense (fools), as in Scott Adams' example: "IGNORING ALL ANECDOTAL EVIDENCE - Example: I always get hives immediately after eating strawberries. But without a scientifically controlled experiment, it’s not reliable data. So I continue to eat strawberries every day, since I can’t tell if they cause hives";

  • Too much concern for the possible interruption of flow of money or power in one's direction (gonifs).



In conclusion, the anecdotalist refrain of "your evidence is anecdotal" [therefore of little or no value] when used repetitively against competent observers is the refrain of eggheads, fools and gonifs.



In healthcare, the end result is "your patient's dead."



My "anecdotal relative" injured in a mid-2010 HIT mishap is sadly an example.



[June 2011 addendum: my relative, after much suffering, has now died of complications of the "anecdotal HIT mishap" - ed.]



As for myself, I am a Markopolist (see my Sept. 2010 post "Health IT: On Anecdotalism and Totalitarianism").



-- SS

Sunday, March 6, 2011

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

Saturday, March 5, 2011

On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts.

Note: the reports to which this post refers are available as a set of PDF's from the University of Sydney, NSW, Australia at this link (12 Mb, .zip folder), or at "A study of an Enterprise Health information System" at http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146.

March 6, 2011 addendum. Also see my new post "What to do about the state of the ED EHR in NSW?"

Over ten years ago now, 1999 in fact, I started my healthcare IT difficulties website.

That site, "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" now resides on a Drexel University server in Philadelphia, Pennsylvania USA at this link, and used as a teaching resource.

I started the site after observing, for lack of a better description, "crazy stuff" in the commercial healthcare information technology sector.

Crazy stuff such as EMR systems for ICU's that crashed regularly and spread pathogens around, EMR's for invasive cardiology cath labs that were an informational jumble and abyss and that also issued regular General Protection Faults and died, lack of Medical Informatics expertise (and actual disdain for it) in healthcare IT projects, grossly incompetent IT leaders, and hospitals uncritically and enthusiastically buying these products as if they were a plug and play, proven technology.

To make matters worse, I also observed executives expressing a hostile indifference to glaring deficiencies.

My observations about health IT and about responses to my counsel brought to mind the biblical passage:

"Give not that which is holy unto the dogs, neither cast ye your pearls before swine, lest they trample them under their feet, and turn again and rend you." - Matthew 7:6

I was never afforded the opportunity to perform a forensic analysis of the internals of these systems, being that I was not allowed to obtain the software or "schematics" of the data structures. In fact, to make the cardiology system usable, I ordered the IT staff to simply discard the internal data dictionary, relational data structures, input screens, and analytic routines, and rebuild them - from scratch - using a proper Medical Informatics-based, cardiology domain expert-driven, iterative and incremental (agile) approach.

The result was a resounding success, and was described in a written report as "exceptional" by national specialty association reviewers invited to evaluate the effort.

(A success for which, I might add, I and my enlightened executive sponsor were paradoxically demonized by the IT department and hospital executives; cf. Matthew 7:6.)

Now, an Australian researcher of considerable computer and database expertise, Professor Jon Patrick at the University of Sydney, has put considerable ink to a forensic evaluation of the internals and external reactions to an EMR system "built in America", Cerner Firstnet.

Professor Patrick holds a Ph.D. from Monash University. He came to the University of Sydney from Massey University, New Zealand, where he held the foundation Chair of Information Systems. Professor Patrick won Australia's national Eureka science prize in 2005 for developing a natural language processing system that detected financial scams in web pages at the behest of the Australian Government.

FirstNet is an ED EHR that government officials decided must be installed in ED's of public hospitals throughout the Australian state of New South Wales. Promo material below, click to enlarge:

FirstNet promo material, page 1. Click to enlarge. (Hmm ... Is there a subliminal message in the picture of the doctor and nurse?)


FirstNet Promo material, page 2. Click to enlarge.

The initiative's been underway for several years, and the result is a group of apparently very unhappy Wal-Mart shoppers. (I guess the correct line would be "unhappy Big W shoppers" for those Down Under.)

Prof. Patrick had written a preliminary essay on the issue entitled, in rhetorical question-style, "The Story of the Deployment of an ED Clinical Information System: Systemic Failure or Bad Luck?" back in 2009. He apparently found himself in considerable hot water for doing so due to 'pushback' as I described at "Academic Freedom and ED EHR's Down Under: An Update". However, his university stood by him in defense of academic freedom (and of the sanctity of those in the healing arts, I might add).

He's spent the intervening time expanding the analysis of the ED clinical system and its deployment considerably, right down to the fine nuances of relational database design in complex domains (such as biomedicine).

As I wrote in an initial post "A Study of an Enterprise Health information System - Finally, an Informatics Scientist Does A Rigorous Review of a Commercial EHR System, by Cerner", the TOC of his new analysis are these (the files are available as a .zip archive at this link):

3.0 Part 0 - Executive Summary
3.1 Part 1 - A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck? First published here in Oct 2009, revised Dec 2009.
3.2 Part 2 - Discussions with ED Directors: Are we on the right track?
3.3 Part 3 - Discussions with Software Performance Experts.
3.4 Part 4 - Conceptual Data Modelling.
3.5 Part 5 - Database Relational Schema and Data Tables.
3.6 Part 6 - Coalescing the Analyses of the ER Diagrams, Relational Schemata and Data Tables.
3.7 Part 7 - The Integrated Assessment.
3.8 Part 8 - Future HIT Regulation Proposals.
3.9 Part 9 - Ockham's Razor of Design. Published at the IHI conference, Nov 2010 Washington.

I have been reading these sections, and have found the technical sections (parts 4-6) highly informative about a major suspicion I've held for many years.

I suspected chaos in the health care IT software engineering process, with inadequate attention to quality, rigor, fine detail, resilience engineering, talent management and other practices essential in development of mission critical products of any type.

Prof. Patrick's forensic analysis, while not proof of my concerns, certainly supports them. If Boeing produced aircraft with malfunctioning engines, broken seats, defective flaps, tires that blew on landing, and rust right out of the factory (like the Chevy Vega of old?), one might suspect the development and manufacturing environment could be substantially problematic.

The theme of apparent violations of fundamental precepts of relational database design run consistently through his analysis of the FirstNet product.

Without getting too technical (which I can, having written successful relational database-based clinical information systems of considerable complexity for challenging environments, with novel user interaction design besides), I see evidence of developmental chaos.

Examples: primary key-foreign key inconsistencies and problematic usages ("keys" are flags used to link sets of information about some object or entity, such as a patient to their diagnoses or meds), internal field nomenclature faux pas (there are best practices on how to do this to enhance software quality and maintenance), cryptic documentation , "stale bits" (old code and data) from past iterations remaining to create "glitches", unreliabilities and new problems, and other technical sins apparently abound.

These can be read about in sections 4-6 of Prof. Patrick's analysis. The issues can be summarized as he did in the part 6 Abstract:

Consistent weaknesses in sections of the Millenium clinical information System (CIS) are revealed in the combined study of the ERD (entity-relationship diagram), logical schema and the data tables. PK (primary key, i.e., unique identifier) values are not always defined unambiguously at the design level and data tables reveal inconsistencies in declarations and data validation. There is evidence that keys are managed by software within the application rather than by the in-built functions available in the database management system leading to less confidence in data integrity.

He goes on to relate:

The [technical design] weaknesses in terms of clinical work practices, that have been identified are only likely to show up in occasional circumstances with a combination of processing and data values separated in time. [In other words, the resulting errors are unpredictable, and depend on variable factors about the patient's data and user's attempted actions that cannot be predicted ahead of time - ed.] Staff are not likely to associate one instance of missing or mis-processed data with another. This spasmodic nature tends to lull staff into a false sense of security that the mis-processing is either inconsequential or an accident of their own making. We recommend that each and every mis-processing experience be recorded as accurately as possible so that appropriate computational forensic analysis can correctly identify if weaknesses in the underlying technology have been the source.

These are dead-serious matters, literally. One's well being in an ED should not depend on random chance. If you are the "lucky patient" who Wins the Lottery or Hits the Jackpot on health IT mis-processing, or whose clinicians are distracted by user experience flaws, "workarounds", demoralization or other issues, you might end up maimed - or in the grave.

The ED EHR Slot Machine. Click to enlarge. You've hit the ED EHR mis-processing jackpot! Perhaps today is a good day to die...

I do not believe mission critical software for, say, avionics, or for implantable medical devices, suffers such sloppiness. (In part due to regulation, which health IT lacks entirely in the U.S.).

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 — 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).

and

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).

That said, I will now comment in more detail on a part of the analysis readily understandable by 'database laypeople': part 2, "Discussions with ED Directors: Are we on the right track?" (again, probably a rhetorical question).

In this section, candid discussions were held with the Directors of seven Emergency Departments in New South Wales public hospitals assessing the impact of the introduction of the FirstNet information system into their ED's. The effort has been ongoing for approximately the last 5 years.

Numerous themes remind me of my own observations as in my aforementioned Drexel health IT difficulties site:

The implementation processes of the HSS [governmental Health IT support, a.k.a. Health Support Services - ed.] were criticised for refusing to acknowledge the validity of complaints, failing to fulfil promises, creating an ineffective change process, refusing to consult clinicians, using strategies to disenfranchise participation by clinical staff, and introducing a technology that doesnʼt fit their needs.


All of these themes are familiar to me, and are representative of the phenomena of non-clinician, IT-centric arrogant ignorance, paternalism, leadership-pyramid inversion (i.e., the facilitators thinking and acting as if they are the enablers of healthcare), playing nasty politics with clinicians to avoid work, and minimizing job and results-evaluation discomfort for those lucky enough to secure cushy IT jobs in health IT support.

In determining the clinical documentation needs of staff, the Directors claim that the HSS ignores the needs of staff. Directors report over-supply of irrelevant information and under-supply of needed information in the clinical interfaces. ["Legible gibberish" - ed.] The environment consists of counter-intuitive interfaces where data is entered by one person in one part of the system so that it is not discoverable by another person.

The interfaces have inappropriate sizing of objects, confusing functions, redundant steps, unused functions and cluttered interfaces. These difficulties have resulted in increased time usage on the system resulting in decreased time with patients for no gain in administrative or clinical outcomes. Staff minimise their use of the system to as little as possible with work arounds being constantly developed and improved. Staff morale has been clearly degraded with accompanying loss of respect for the HSS and more generally NSWHealth’s authority.

These concepts are described and illustrated in my multi-part essay on the healthcare IT mission hostile user experience at this link. They represent major deviations from good information science, information presentation and human-computer interaction (HCI) precepts.

... Workarounds in using the system are the most obvious tangible response of staff to the functions of the system they consider unsatisfactory. The key aspect of workarounds is that they constitute a subversion of the policy processes created by the software that the staff are not prepared to collaborate with. Some of these strategies may even compromise the legal status of the records in the system: such as not signing documents, unrecorded alterations to documents, and test results not attached to patient records.

... Another form of staff protest workaround is the strategy by staff to avoid using the system by either having other people [presumably underlings - ed.] do the work on the system, inserting minimal amounts of information thereby reducing the value of the information and passing information to other staff verbally.


Workarounds to IT obstacle courses and booby traps, as noted by Koppel, Wetterneck, Telles & Karsh in "Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety", J Am Med Inform Assoc. 2008 Jul-Aug;15(4):408-23, increase, not reduce, the risk of EHR-mediated medical errors. I wrote about their findings at "Business v. clinical computing: Workarounds to Barcode Medication Administration Systems" at this link.

It should be kept in mind that these are mission-critical systems for use in a fast-paced ED, not tracking systems for widgets - or for lab rats.

The lack of appropriate reporting functionality of the system has had a serious impact on the critical work of the Directors on process improvement ... It was evident in talking to the Directors that they have antennae highly tuned to the processes happening in their departments and the public health issues that emerge from their patients.

On a daily, weekly and monthly basis they review single cases, collections of common cases, and variations in established disease profiles to understand the success of their work and to detect emerging new trends or potential new disease outbreaks. At an administrative level they are asked to review cases either because of the return of new test results or due to complaints or reviews from other bodies.

The FirstNet installation has removed all the reporting functionality the directors had in their previous system EDIS while destroying their information sources for process improvement, and their mechanisms for creating and collaborating in research projects. This, in turn, has led to a loss of motivation to enter data further degrading the value of the data held within the system.

Reducing the value of a tool to people, and decreasing their ability to perform their jobs (especially when they take great professional responsibility and pride in those jobs) predictably leads to demoralization, demotivation and a cascading path down a whirlpool of failure.

The disadvantages of the system for day to day operations is well demonstrated by the issues around the ordering system. It is stated to be overly complex and requires a large deal of repetitive information to be input for multiple orders on one sample, plus specialist data entry knowledge that requires every joint order to have exactly the same timestamp. Ordering was the first accession where staff recognised that information is sometimes sent to the wrong staff, both arriving where it shouldn’t and not arriving where it should.

... Further mis-processing is seen with the cancellation of orders when a patient is transferred to a hospital ward from the ED. The results of orders, particularly radiology, often need to be checked by senior staff, but the system has no functionality to enable efficient processing of orders that have normal results, and thereby require no further attention.

I do recall another EHR system, by the same vendor I believe, where an "upgrade" in the recent past led to orders ending up in the wrong places (link):

... Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way.

The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.

[In other words, data entered by clinicians was going into the wrong charts. How many charts were involved? Does the hospital system even know, I wonder? - ed.]


Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.

Not to pick on this vendor; these "glitches" seem to be occurring in many HIT vendor's products.

All this, dear readers, is simply madness.

... Patient record retrieval is an important aspect of the staff work with patients, therefore its efficiency and accuracy is of vital importance to the activities of the ED. Staff were particularly pointed about the deterioration of this functionality in FirstNet compared to the previous system EDIS. [ED information system - ed.] There were cases where records could not be found, confusion about where data was stored in the patient record with different staff writing the same information into different parts of the record, and the [manual] rewriting of records [requiring a large amount of additional labor and time, not exactly a commodity in an ED -ed.] due to insertion of content into the wrong record.

These are critical issues. If you can't get information out of a computer in a timely fashion, what you have is a very expensive doorstop. I also note that a document imaging system that images hand written charts would not have these problems...

Prof. Patrick addresses the oft-heard canard that such complaints are the complaints of "Luddite doctors", old dogs who simply don't want to learn new tricks:

The staff in the ED are now generally experienced at using some form of clinical information system, many for over 10 years. This experience gives them a keen sense of what is possible with technology as well as the deficiencies in the existing systems. Combining this experience and knowledge with a sense of professional responsibility for process improvement enables them to judge quite acutely when a system is well designed or not. Hence their observations about elements of systems that are not parsimonious enough for optimal clinical efficiency deserve to be respected.

That it even needs to be written that the opinions of experienced medical professionals on the tools they are coerced to use by non-medical outsiders "deserve to be respected" gives testimony to my observation of a cross-disciplinary invasion of healthcare by the IT profession (among others).

Workflow and dataflow and the continuity of these processes are vital to the smooth running of a complex socio-technical process. ED staff have shaped these flows over a period of years and socialised all staff into the streaming. The directors have found that with the workflow of staff needing to use both clinical and nursing notes at the same time, their separation in FirstNet is deleterious. One department considered that the many nursing and medical notes accumulated over a day had to be kept in a single continuous sequence in the clinical record. Their workaround was to keep the one note page open for 24 hours to maintain the needed continuity in the patient record and avoid staff using a significant amount of time at the computer searching for needed information.

Nemeth and Cook explain how an ED EHR can be developed and marketed that interferes with, not supports, the workflows common in ED"s worldwide, in "Hiding in plain sight: What Koppel et al. tell us about healthcare IT", J Biomed Inform. 2005 Aug;38(4):262-3:

... On the surface, healthcare work seems to flow smoothly. That is because the clinicians who provide healthcare service make it so. Just beneath the apparently smooth-running operations is a complex, poorly bounded, conflicted, highly variable, uncertain, and high-tempo work domain. The technical work that clinicians perform resolves these complex and conflicting elements into a productive work domain. Occasional visitors to this setting [i.e., IT personnel, non-medical bureaucrats, etc. - ed.] see the smooth surface that clinicians have created and remain unaware of the conflicts that lie beneath it.

The technical work that clinicians perform is hiding in plain sight. [Hiding from the uninformed, that is - ed.] Those who know how to do research in this domain can see through the smooth surface and understand its complex and challenging reality. Occasional visitors cannot fathom this demanding work, much less create IT systems to support it. Progress in healthcare IT systems relies on scientific data on the actual, not the perceived, nature of day-today operations.

It increasingly seems the only place the faux-expert, healthcare-facilitor, cybernetic snake oil salespeople are going ot learn this simple lesson is in the courtroom...

A recent article in the press has presented evidence that access block times in EDs across the state of NSW are worsening.

As regards causality, it perhaps takes being an IS dept. director in a hospital - or holding elected office - to be unable to recognize the nose at the front of one's face.

Prof. Patrick wraps up this section of his forensic analysis as follows:

A number of conclusions can be drawn from the study:

1. Staff are entirely dissatisfied with the SBB and they feel that the deliverables have significantly failed to match the promises.

2. The Directors see that the HSS have failed in their support of the frontline of emergency care across the Sydney basin and their practices are decidedly lacking in proper engagement with the user community which should be their primary concern.

3. Some of the consequences of the HSS decision not to provide the reports needed by the Directors have lead to them being seriously hampered in being able to monitor the quality of their own department’s practices and wider changes and trends in community health.

4. The inefficiencies introduced by this technology have lead to a litany of complaints about its behaviour that have gone unheeded over the past three years.

5. It has lead to major strategies to work around the system by staff at all levels, to the point of complete avoidance by some staff.

The major consequences of these failings in the eyes of the ED directors are:
  • Lost productivity and inefficiencies,
  • Increased risks to patients,
  • Disillusionment of staff and loss of morale.
Considering my own relative's injuries originating in an ED EHR mishap, I think I can safely add to Prof. Patrick's final tally an additional item:
  • Patients have been harmed.
This is not a pretty picture.

I'm confident the Australian legal system abhors negligence as much as our own here in the U.S. If patients are injured and/or die as a result, considering that the Programme leadership and IT vendors knew - or should have known - of these deficits, it would not surprise me if criminal negligence charges begin to appear.

These issues are not exactly rocket science, and an expanding literature base has been appearing in recent years. See, for example, my recent post "An Updated Reading List on Health IT" at this link.

I can only add that my own relative was nearly killed as a result of a number of the phenomena described in Prof. Patrick's analysis.

More on other sections of his report at another time.

-- SS

March 6, 2011 addendum:

Also see my new post "What to do about the state of the ED EHR in NSW?"

-- 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

Tuesday, December 1, 2009

"We are unable to share documents relating to problematic EHR's as our contract with Cerner includes a confidentiality clause ..."

In my post "Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development" I reported on the Univ. of Sydney's somewhat belated support for academic freedom, and the reappearance of an essay on ED electronic health records problems in NSW by one of its informatics faculty, Prof. Jon Patrick, after an apparently government-initiated attempt at censorship.

A new update of the paper "A Critical Essay on the Deployment of an ED Clinical Information System - Systemic Failure or Bad Luck" version 6, has now been posted by Dr. Patrick at this link on his department's web pages (a direct link at this time to the PDF is here).

The press has started to take notice. A piece in the Sydney Morning Herald entitled "Health department accused of censorship" appeared on Nov. 28 here.

That piece was noted by Computer Weekly in the U.K. in a piece entitled "Claim of censorship over Cerner system" here. The U.K. suffers a severe EHR epidemic (the UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.)

[12/3/09 update: the piece has disappeared, then reappeared, at Computer Weekly. In case it disappears again, a copy of the article from Google's cache is here.]

From the U.K. Computer Weekly article:

The Sydney Morning Herald and ZDNet in Australia report that the University of Sydney removed from its website - temporarily - a negative essay about a Cerner system which had been installed at hospitals in New South Wales.

The author of the essay is a medical IT professor, Jon Patrick, who is reported to have claimed that NSW Health, which is part of the government of New South Wales, put pressure on the university to take down the paper.

If true, it would tie in with what's been happening in England where mentions of Cerner in a negative context are being officially discouraged.

Cerner is due to be installed at hospitals across London as part of the National Programme for IT [NPfIT] but several trusts that have already gone live - including the Royal Free and Hampstead, Barnet and Chase Farm, and Barts and The London - have run into serious problems, including the losing of patient appointments and patients not being treated.

A showcase Cerner site at Homerton ceased mentioning Cerner in its public board papers after doing a deal with NHS Connecting for Health and the Department of Health. Homerton also rejects FOI requests related to its discussions on Cerner.

Homerton told me: "We are unable to share documents relating to these meetings as our contract with Cerner includes a confidentiality clause and as such disclosure of the information could give rise to an actionable breach of confidence."

I am repeating that last sentence for effect:

We are unable to share documents relating to these meetings as our contract with Cerner includes a confidentiality clause and as such disclosure of the information could give rise to an actionable breach of confidence.


This is solid evidence of such confidentiality clauses in HIT contracts and the chilling effect they have, along with dangers of "hold harmless" clauses. This style of EHR contracting is a practice now under investigation by the U.S. Senate Committee on Finance, as in their Oct. 16, 2009 letter to major healthcare IT vendors and management consultants from Senator Charles E. Grassley (ranking member). A copy of that letter is here (PDF).

I have written on the dangers of such clauses before as in my July 22, 2009 letter in the Journal of the American Medical Association "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" (http://jama.ama-assn.org/cgi/content/extract/302/4/382), as well as my much more thorough posting on these issues in the essay at my Drexel University website here.

In that essay I observed:

Regarding healthcare IT "Hold Harmless" and Defects Gag Clauses, I also question whether hospital executives violated their fiduciary responsibilities by signing such contracts, and violated Joint Commission standards of hospital leadership conduct as well ...


Let's look at the Joint Commission Hospital Accreditation Program Leadership Chapter, and its standards for hospital leadership (link, PDF):


Leadership
LD.01.03.01

Standard LD.01.03.01
The governing body is ultimately accountable for the safety and quality of care, treatment, and services.

Rationale for LD.01.03.01
The governing body’s ultimate responsibility for safety and quality derives from their legal responsibility and operational authority for [organization] performance. In this context, the governing body provides for internal structures and resources, including staff, that support safety and quality.


The governing body has a legal responsibility for safety and quality, not just a moral obligation. One of the "internal structures" is healthcare IT that is safe and effective and that does not expose patients or staff to undue risks.

How does signing "hold harmless" and "defects gag order" clauses with an HIT vendor serve such a purpose, exactly?

Hospital executives know, should know, or should have known that such provisions would remove incentives for health IT vendors to produce the best products and to correct deficiencies rapidly, thus increasing risk to patients and clinicians.

Elements of Performance for LD.01.03.01
5. The governing body provides for the resources needed to maintain safe, quality care, treatment, and services.


One of those resources is health IT.

Standard LD.02.01.01
The mission, vision, and goals of the [organization] support the safety and quality of care, treatment, and services.

Rationale for LD.02.01.01
The primary responsibility of leaders is to provide for the safety and quality of care, treatment, and services. The purpose of the [organization]’s mission, vision, and goals, is to define how the [organization] will achieve safety and quality. The leaders are more likely to be aligned with the mission, vision, and goals when they create them together. The common purpose of the [organization] is most likely achieved when it is understood by all who work in or are served by the [organization].


How is a contract with an HIT vendor that calls for hiding defects in health IT and exposing staff to liability for defects in same serving the above purposes?


Standard LD.02.03.01
The governing body, senior managers and leaders of the organized medical staff regularly communicate with each other on issues of safety and quality.


Does that include communication on health IT defects? Can a medical staff member ask to see a database of such defects when the hospital has signed a nondisclosure of defects agreement with an HIT vendor?

Rationale for LD.02.03.01
Leaders, who provide for safety and quality, must communicate with each other on matters affecting the [organization] and those it serves.


I ask the same question as above.


Standard LD.03.01.01
Leaders create and maintain a culture of safety and quality throughout the [organization].


Safety for whom, exactly? Patients, or patients and staff?

How is exposing professional staff to undeserved liability from defective health IT serving the creation of a culture of safety and quality for them? How is suppressing information on health IT defects and problems helping patient safety and care quality?

How is lack of seeking informed consent on health IT use from patients whose care is mediated by health IT devices with known but undisclosable defects creating a culture of quality?

How is hiding such defects creating a culture of quality in the community's other hospitals, that may be considering purchase of the very same health IT?

Standard LD.03.04.01
The [organization] communicates information related to safety and quality to those who need it, including staff, licensed independent practitioners, [patient]s, families, and external interested parties.

Rationale for LD.03.04.01
Effective communication is essential among individuals and groups within the [organization], and between the [organization] and external parties. Poor communication often contributes to adverse events and can compromise safety and quality of care, treatment, and services. Effective communication is timely, accurate, and usable by the audience.


Are physicians and nurses explicitly informed by administration that clinicians are liable for bad outcomes due to software problems? Are they informed of the gag clause? Are patients informed of unremediated health IT defects existing at time of service?

This standard seems a veritable smoking gun regarding breach of fiduciary responsibility and Joint Commission obligations when hospital leadership signs agreements specifically excluding the sharing information about health IT defects and complaints. It is already known that hospitals maintain lists of health IT defects, some in the thousands of items. A number of the defects rise to the level of creating considerable risk to patients, and nobody is in a hurry to remediate them. (See my proposed although somewhat tongue in cheek "HIT Informed Consent" that describes some of these known defect categories here).

Standard LD.04.04.03
New or modified services or processes are well-designed.

... 3. The hospital's design of new or modified services or processes incorporates: Information about potential risks to patients.

4. The hospital's design of new or modified services or processes incorporates: Evidence-based information in the decision-making process. Note: For example, evidence-based information could include practice guidelines, successful practices, information from current literature, and clinical standards.


How does the contractual inability to communicate about health IT defects, which its executives willingly sign, serve this purpose?

Standard LD.04.04.05
The [organization] has an organization-wide, integrated [patient] safety program.

... 12. The hospital disseminates lessons learned from root cause analyses, system or process failures, and the results of proactive risk assessments to all staff who provide services for the specific situation.


Disseminates lessons learned, except when the HIT contract they've signed with a vendor forbids it, that is.

The practices of the health IT industry, and the dealings of the hospital leadership with that industry, may in fact be a scandal of national (or international) proportions.


International scandal, indeed.

I predict these EHR confidentiality clauses will end up causing great loss of money in failed systems, and/or harming patients, due to the chilling effect they have on revelation of defects and problems by clinicians and executives alike.

Those who signed them will very likely be held liable, at least in the U.S., as the clauses breach the safety standards of the accrediting agency for hospitals here, the Joint Commission. I wish the signers of such contracts good luck in the courtroom.

In Australia and the U.K., I cannot comment, but also wish good luck to those who signed these clauses when lawyers go full court press on EHR-mediated debacles.


-- SS

Tuesday, November 10, 2009

Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development

In "Academic Freedom and ED EHR's Down Under: An Update" I wrote about the disputed essay on electronic health record (EHR) problems in the Australian state of New South Wales (NSW) by medical informatics professor Dr. Jon Patrick, Health Information Technologies Research Laboratory (HITRL), University of Sydney.

The essay was entitled "A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck?"

I am happy to report that an updated version of the essay, version 5, is now available from Dr. Patrick's university web site at http://www.it.usyd.edu.au/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146 . It can be downloaded from the icon at Item 6.

This is a welcome development.

The essay is now labeled as an Op-Ed (Opinion Editorial).

-- SS