Monday, April 13, 2009

Should Google Seek the Resignations of Those Responsible for This Healthcare IT Debacle?

Simply amazing. One of the richest and most "leading edge" IT companies in the world with almost unlimited resources and access to expertise commits one of the most fundamental biomedical information science (a.k.a. informatics) blunders, as in the taxonomy in my post here, at the level of "likely to cause patient harm in short term if uncorrected."

I have repeatedly written over at least the past ten years that applying the leadership and methodologies of business IT to clinical computing is both ill conceived and dangerous, as business computing and clinical computing are two very different computing subspecialties, the latter requiring quite specialized leadership and approaches.

I've written it at academic sites, in magazines, in newspapers, and other venues.

Yet, as we have observed at HC Renewal regarding other flavors of healthcare mismanagement and malfeasance, these words seem to suffer an anechoic fate.

Here we go again with another example of what appears to be gross mismanagement of clinical IT by business IT personnel and organizations. The following type of debacle is sooner or later going to kill patients and
must end, immediately:

Boston Globe
Electronic health records raise doubt
Google service's inaccuracies may hold wide lesson
["may?" - ed.]
By Lisa Wangsness, Globe Staff
April 13, 2009

WASHINGTON - When Dave deBronkart, a tech-savvy kidney cancer survivor, tried to transfer his medical records from Beth Israel Deaconess Medical Center to Google Health, a new free service that lets patients keep all their health records in one place and easily share them with new doctors,
he was stunned at what he found.

Google said his cancer had spread to either his brain or spine - a frightening diagnosis deBronkart had never gotten from his doctors - and listed an array of other conditions that he never had, as far as he knew, like chronic lung disease and aortic aneurysm. A warning announced his blood pressure medication required "immediate attention."

"I wondered, 'What are they talking about?' " said deBronkart, who is 59 and lives in Nashua.

DeBronkart eventually discovered the problem: Some of the information in his Google Health record was drawn from billing records, which sometimes reflect imprecise information plugged into codes required by insurers. Google Health and others in the fast-growing personal health record business say they are offering a revolutionary tool to help patients navigate a fragmented healthcare system, but some doctors fear that inaccurate information from billing data could lead to improper treatment.


(Addendum April 19: a first hand account of this problem is at e-patients.net here.)

What manner of amateurs made and approved the decision to
map semantically and often medically imprecise, and often deliberately overstated or misused billing codes to diagnoses, and then display the diagnostic terms to a user - ANY user, patient or "learned intermediary" - in an electronic health record?

Not to mention how poorly conceived and implemented many of the HIT billing systems themselves are, making billing data even less trustworthy...


Injecting humor into a most somber post,
Homer succinctly summarizes the situation.


It is common knowledge to any competent person in healthcare informatics that doing what was done by Google Health is prone to create exactly the kind of situation that occurred.

Insurance data, by contrast, is already computerized and far easier and cheaper to download. But it is also prone to inaccuracies, partly because of the clunky diagnostic coding language used for medical billing, or because doctors sometimes label a test with the disease they hope to rule out, medical technology specialists say.

One does not have to be much of a "specialist" to make this realization. Almost anyone who's ever practiced medicine could probably have told Google's designers, developers and programmers this. This raises a number of questions, which also do not require a specialist to raise:

  • What were the designers, implementers and management of this project thinking?
  • Who was leading the project?
  • What were there backgrounds?
  • Who made the decision to implement in this manner?

Danny Sands raises the obvious:

"The problem is this kind of information should never be used clinically, especially if you don't have starting or ending dates" attached to each problem, said deBronkart's primary care doctor, Daniel Z. Sands, who is also the director of medical informatics at Cisco Systems.

Indeed.

Personal health records, such as those offered by Google Health, are a promising tool for patients' empowerment - but inaccuracies could be "a huge problem," ["could be?" - ed.] said Dr. Paul Tang, the chief medical information officer for the Palo Alto Medical Foundation, who chairs a health technology panel for the National Quality Forum.

For example, he said, an inaccurate diagnosis of gastrointestinal bleeding on a heart attack patient's personal health record could stop an emergency room doctor from administering a life-saving drug.


And when such an event occurs and a patient is harmed or killed, who then is held accountable - and who is held harmless? (Oh wait ... we know the answer to that question thanks to Koppel and Kreda...)

This "billing data" issue and other EHR issues like it are not rocket science, they are Medical Informatics 101.

I've seen such issues before, such as at "AOL kerfuffle: information technology vs. information science, a distinction lost at industry's peril" and at "On Intel's and Walmart's prescription for Healthcare IT."

I summed the problem up like this at the post "A Biomedical Informatics Manifesto":

Biomedical Informatics as a specialty might as well be invisible. Amateurs** rule HIT.

(** Amateur in the sense that I am a radio amateur, not a telecommunications professional and would not deem myself appropriate to design and run a critical telecommunications project).

Perhaps, though, I should have added "amateurs rule HIT, and even worse are too often managed by incompetents."

I believe Google should conduct a top to bottom investigation of the management chain and the decision making process that led to such a fiasco, which can only further erode public confidence in electronic health records at a time of national distrust in Big Business and Big Medicine.

Those who made such design and implementation decisions without appropriate input from those who know better, or worse, those who might have overridden or ignored such counsel, should be dealt with appropriately. (If it were me, I'd ask for their resignation, but that's my opinion.)


Clinical medicine, Electronic Health Records and patients' well being are not an information technologists' learning lab.

Also of concern to me, this is the type of data our government seems to be touting for use in Comparative Effectiveness Research. (It is also of concern to me in this regard that our new Secretary of HHS was the former Kansas commissioner for insurance from 1994 to 2002, and such billing data is likely where the majority of her experience with medical datasets resides.)

Finally, like the financial schemes of the past decade, I can only wonder when the computational House of Cards that is being built in healthcare as a result of the quasi-religious
Syndrome of Inappropriate Overconfidence in Computing, and worship of its priests, the IT Whiz Kids and consultants to whom domain expertise is optional, will come crashing down.

-- SS

Addendum:

A physician correspondent who wishes to remain anonymous writes (emphases mine):

[The Boston Globe article] could not have come at a better time.

Just today, a spouse had his "home grown" PHR for his wife who was hospitalized with multiple medical problems, including advanced metastic breast cancer and complex vascular disease. He has an elaborate PHR with history, treatments, allergies, medication lists, etc.

It was so impressive that when this 80ish year old patient was admitted, he gave the medication list from the computer to the physicians and nurses. It appeared so reliable that not one health care professional bothered to question it or reconcile it with the labels on the bottles (everyone is so busy nowadays clicking and scrolling the computer silos for information).

As it turns out,
he left out a decimal point on a dose of a potent medication that should have been 2.5 mg. The computer printed a legible list (with other errors too) stating the dose of this med was 25 mg per day (10 times too much). It was ordered that way by the doctors. It got to the pharmacy, but somewhere in this complex chain, a non physician non nurse individual got the dose to the patient correctly as 2.5 mg [fortunately, the error was caught, this time. What about next time? - ed.]

Being a detective with an eye for detail and a stickler for accuracy, I happened to notice the error when the spouse was showing off his PHR to me.

Again, this is one case with potentially dangerous consequences of a pervasive error generated in the PHR by flawed data entry. It was not a Google or Health Vault device, but I cannot believe that these companies have garbage filters on their devices to prevent the "garbage in, garbage out" syndrome.
Good medical care is being subverted by these experimental devices.

Upon scratching the surface of PHR, EMR, and CPOE devices' functional impact on the administration of medical care, the dangers are widespread. This toxicity is covered up from scrutiny by the "non-disclosures" and "hold harmless" contractual obligations described in the Koppel and Kreda report
.

One wonders how many incidents like this happen every day and are being concealed by the HIT industry and the pundits profiting handsomely from selling defective HIT devices. I am quite concerned that nobody really knows. This is not science.

On a final sobering note, as the "hold harmless" and "defects gag" clauses are purged from HIT contracting, which they will most certainly be, I would suggest the many amateurs in HIT obtain some very solid liability insurance covering patient harm related to their systems and their advice.

For they may just find themselves as defendants answering questions on the witness stand in front of a hungry plaintiff's attorney, a jury of average citizens, bereaved relatives of patients who were harmed via IT misadventure, and questions composed by people of my background. These questions will place the true nature of their expertise and qualifications to be tooling around with medical care under severe scrutiny.

That will likely not be very pretty.

-- SS

April 22 addendum:

In comment #15 to this post
Matthew Holt issued this filled with absolutes ad hominem comment ...

Seriously, MedInformaticsMD, you are so pissed off with everyone in IT [everyone? - ed.] that you're now part of the problem [problem of vendors creating bad IT? - ed.] Do you seriously think that the people at BIDMC, Google and everyone else in health IT (even Cerner) just dont give a shit? [I cannot read minds. I can only see results - ed.] Or do you think that they might be trying to figure out how to solve these problems [of course they're trying to solve problems, but good intentions without requisite ability and expertise are inadequate in healthcare - ed.], and perhaps could you some constructive help. Rather than a barrage of attacks on anything they try to do. [Anything? You mean, such as in this post praising Google in areas where they do leverage their expertise properly? -ed.]

Perhaps my direct Chairman of Medicine-after-patient-mishap tone in offering the most constructive of criticism - i.e., don't embark on medical projects in which you are over your head, find people who do know the domain and let them lead, don't release anything in medicine without appropriate, rigorous premarket trials - upset him. In addition to the inserts above, in the comments section I replied:

I'm sorry you feel that way.

I'm not sure what "problem" you're referring to, but if it's harming patients due to badly implemented HIT, I'm certainly not part of that problem.

As just one example, my website on HIT difficulties serves as a resource read internationally on how to best avoid HIT errors, has been online for a decade, and is quoted in one of the newest and best books on HIT, specifically "Medical Informatics 20/20."

Did anyone at BIDMC, Google or Cerner ever read it? Did you ever read it? If not, why not? It is in fact the first link that comes up on a google search on "healthcare IT failure", for example. Do they take it seriously? If not, why not?

I believe they were negligent on this project. This suggests they need to give a bit more of a s--- about their work, expecially since real, live patients are involved and the mistake made was so fundamental.

Finally, see my post "A Software Engineer's Eloquence on Health IT" for what I consider an attitude of someone who really does give a s--- about such matters.

Finally, I see no links to my decade-old academic website on HIT difficulties over at Matthew's blog. One wonders why. It may have to do with a tension between the statement that "
the Health Care Blog (THCB) has acquired a reputation as one of the most respected independent voices in the healthcare industry" and the post "A Shout out to our sponsors."

Healthcare Renewal has no sponsors and does not take advertising. We report, you decide.

-- SS

23 comments:

Marilyn Mann said...

yikes!

InformaticsMD said...

Yikes, indeed.

-- SS

JPB said...

This is very scary stuff - diagnosis by billing code! I have worried about lack of patient privacy with electronic medical records but I never thought that my health (and life) might be in the hands of some billing codes clerk....

InformaticsMD said...

JPB, your concerns have a basis in fact, but you've selected the wrong target.

It's not the billing codes and people who enter them who have created the problems. It is the business-IT personnel who have spearheaded a cross-occupational invasion into a territory, a subspecialty where they are unqualified and where they do not belong, certainly not in a leadership capacity.

Their appropriate role as facilitator to those who actually know what they're doing has been turned on its head.

The subspecialty I am referring to is clinical computing and, broadly speaking, clinical medicine.

-- SS

Andy Press said...

EMR needs to standarize the code they need and that is not a trivial job.

InformaticsMD said...

EMR needs to standarize the code they need and that is not a trivial job.Again, lack of standards, inadequate standards, etc. was not the issue in this episode.

An apparent vastly simplistic and naive technologist's view of medicine and biomedical information science (a.k.a. informatics) was.

-- SS

Anonymous said...

I agree, standardization in EMR's, Billing, test codes etc. are very well needed.

The issue I see here really is IT folks, many like myself, making bad assumptions and thinking they're doctors.

That's one of the biggest problems with any EHR/EMR system. They claim to be a tool to help clinicians (read, anyone that does patient care) with their daily work.

The problem is, developers/IT staff build tools based on how they think a clinician should work and how they think and see problems. There aren't many developers/IT that were once a doctor, nurse, administrations etc. If there were we wouldn't be worrying about these issues.

Want to fix this? Hire at minimum two roles, IT and a clinician, let them compliment each other.

JPB said...

To MedinformaticsMD,

Your point is well taken but I was not attacking billing code clerks (I did not write as clearly as I should have) but rather that from your article, it appears that diagnoses are being made from billing codes. With all the attendant dangers of misreading and/or speculation, there is a major problem here with EMR's! We need a lot more discussion here to justify implementing the current technology....

Anonymous said...

Google aggregated faulty data. Does Microsoft do any error checking? How could either product detect faulty data, unless all of the "special" coding rules 3rd parties require for providers to get paid are built in?

How many pts are being incorrectly billed and "diagnosed"unbeknownst to them, with all kinds of junk codes being barfed into insurance billing systems. Perhaps you should reconsider "shooting the messenger" - and lay more of the blame on the institutions that created and perpetuate this mess -MIB, Ingenix, and Millman are just a few I can think of.

InformaticsMD said...

Perhaps you should reconsider "shooting the messenger"
The data is the data. People such as myself know its reality. That won't change anytime soon.


I'm not 'shooting the messenger'; I'm recommending dealing with the management and information architects that with nearly unlimited resources, blew the project, by apparently not engaging or listening to even one person who knew better.

The EHR Guy said...

These problems will escalate before there is proper reaction. I doubt there will be proaction to avoid them.

There are too many IT people without healthcare domain knowledge that are entering the market due to its supposed boom.

A few months ago I was going to offer consultation services to a company starting to develop devices for pathology laboratories that would connect to the repositories offered by Google and Microsoft and none of the engineers that I was talking to had previous experience in healthcare informatics. After an hour of discussion and their refuting of well established practices in our domain I decided to stand up and leave the meeting. I let them know that they didn't need a healthcare IT consultant but a very good lawyer.

Thanks,

The HL7 Guy
http://www.hl7guy.com

InformaticsMD said...

There are too many IT people without healthcare domain knowledge that are entering the market due to its supposed boom.

IMO there were too many when I was a CMIO ten years ago. See the website I started as a result of my observations.

After an hour of discussion and their refuting of well established practices in our domain I decided to stand up and leave the meeting.

I'm impressed by your stance.

I think your anecdote illustrates well my observation of a cross-occupational invasion of medicine by IT.

-- SS

Preston Gorman said...

SS, The cross-occupational invasion improved efficiency and quality in other fields...manufacturing, accounting, engineering, graphic design, retail, law etc. What characteristics do you think make health care occupations different?

Off the top of my head I think complexity may be much greater in healthcare. What else in health care negates the general application of computerization as has been done in other fields?

InformaticsMD said...

At least this exec had the decency to resign:

Royal Free chief executive resigns17 Apr 2009

Andrew Way the chief executive at the Royal Free Hampstead Hospital, which was plunged into financial crisis following installation of a new IT system last year, has resigned.

The problems were so serious at Royal Free that, in October, all Cerner Millennium deployments in the capital by local service provider BT and NHS London under the NHS National Programem for IT were suspended.

Problems with the system meant appointments could not be booked and bills could not be sent, resulting in a loss of up to £10m.

An emergency 90-day programme of remedial work was instituted at the Royal Free by BT and Cerner to fix 22 problems in the software. In February this was judged sufficiently successful to allow work on futher implementations to begin.

Kingston Hospital is due to become the next London trust to take the system.

Way’s resignation follows that of Julian Nettel in February as chief executive of Barts and the London, which also experienced similar problems after installing Millenium last year.

Before his role at the Royal Free, Mr Way was chief executive officer at Heatherwood and Wexham Park Hospitals trust, after working as chief operating officer at Hammersmith Hospitals trust.

According to the Health Service Journal Way is leaving to start a new job running a group of hospitals in Melbourne, Australia.

Matthew Holt said...

I agree. We should have patients keep their drug lists the way I sorted my cheat list for my Russian politics exam at university--written on their hands.

Or we could say that perhaps clinical data from all kinds of sources (rx, clinical notes, claims data) is often wrong, and stories like ePatient Dave's are prompts to make it better.

Hey, paper "records" never killed anyone, right? (Ignoring the 200-400K the IOM say die each year from ADE)

Seriously, MedInformaticsMD, you are so pissed off with everyone in IT that you're now part of the problem. Do you seriously think that the people at BIDMC, Google and everyone else in health IT (even Cerner) just dont give a shit? Or do you think that they might be trying to figure out how to solve these problems, and perhaps could you some constructive help. Rather than a barrage of attacks on anything they try to do.

Because your beloved medical profession aint exactly covered itself in glory over its quest for patient safety over the last 7,000 years.

Roy M. Poses MD said...

Matt, if it's really you, I expected better...

You're seriously hypothesizing that paper records caused 200 -400,000 deaths a year in the US from adverse drug reactions. Setting aside questions about the number of deaths due to ADEs, what evidence do you have that even the majority of them are caused by paper records???

By the way, the problems with inferring clinical data from administrative data have been well known in the clinical epidemiology and health services research world for more than 20 years. There is a whole literature on why administrative data is very loosely related to clinical reality.

Blithely substituting administrative data for clinical data in an EHR was, to be very charitable, very stupid.

InformaticsMD said...

Matthew Holt wrote:

Seriously, MedInformaticsMD, you are so pissed off with everyone in IT that you're now part of the problem

I'm sorry you feel that way.

I'm not sure what "problem" you're referring to, but if it's harming patients due to badly implemented HIT, I'm certainly not part of that problem.

As just one example, my website on HIT difficulties serves as a resource read internationally on how to best avoid HIT errors, has been online for a decade, and is quoted in one of the newest and best books on HIT, specifically "Medical Informatics 20/20."

Did anyone at BIDMC, Google or Cerner ever read it? Did you ever read it? If not, why not? It is in fact the first link that comes up on a google search on "healthcare IT failure", for example. Do they take it seriously? If not, why not?

Do you seriously think that the people at BIDMC, Google and everyone else in health IT (even Cerner) just dont give a shit?

I believe they were negligent on this project. This suggests they need to give a bit more of a s--- about their work, expecially since real, live patients are involved and the mistake made was so fundamental.

Finally, see my post "A Software Engineer's Eloquence on Health IT" for what I consider an attitude of someone who really does give a s--- about such matters.

-- SS

InformaticsMD said...

Preston Gorman wrote:

Off the top of my head I think complexity may be much greater in healthcare. What else in health care negates the general application of computerization as has been done in other fields?

You hit the nail on the head. Nothing negates it, but the complexity of biomedicine makes IT integration far more difficult than in other fields.

However, the realization of just how much more complex healthcare is compared to other endeavors is severely underappreciated. I think therein is the crux of the problems.

I use the term "invasion" to imply the above, i.e., marching in with underestimations of the difficulty and false assumptions, and a lack of humility ("we are going to revolutionize medicine!" is a line I've heard all too many times).

I don't know why IT has such overconfidence in its involvement in healthcare. After my own medical training, it's a real puzzle.

If I lacked that training I'd be scared sh--less to get anywhere near a healthcare environment, yet for example I saw nonmedical IT personnel toying around in cath labs and ICU's (of all places) and doing very risky things despite this being pointed out to them.

It was simply incredible to me.

-- SS

InformaticsMD said...

I should add that with the inevitable ending of "hold harmless" clauses, and with tort lawyers catching on to the fact that nonmedical IT people might be doing things that can adversely affect patients (already have seen a civil complaint alleging contribution to patient death by defective HIT), if I were a nonmedical IT person I'd be really concerned from a legal perspective about overstepping one's competencies in this sector.

-- SS

Anonymous said...

Holt, give us a break. You make your living from promoting all the wonder and glory of healthcare IT solving all of our healthcare problems, and denigrating -- personally -- anyone who disagrees with your point of view. You have a long online history of doing this. You are unprofessional, to say the least, and that's why others are finally starting to recognize the scam you are running -- promoting IT through your conference business, all for kickbacks from the very vendors you allow free editorial reign on your THCB website.

Why don't you start identifying blog entries paid for by the vendors that pay for your living? Why don't you also start listing your specific conflicts of interest for companies that you promote that you also accept a paycheck from??

You're no better than the researchers who take pharma money without disclosure or transparency. Stop being vendor IT's bitch, and start helping us solve the real problems of healthcare today.

InformaticsMD said...

Actually, I enjoy point and counterpoint (a.k.a. "fisking") those whose arguments are sufficiently careless and spurious to be a Disneyland of self impeachment.

(Saw that line in a recent WSJ, it's excellent.)

Such people might try to malign me, but they are up against my secret weapon.

First principles and superior brains win over hysteria every time.

-- SS

InformaticsMD said...

(To those who consider my previous post politically incorrect, consider you would not say that about the scores of these people, and I'll bet if your kid had a brain tumor you'd want a doctor with the highest of scores, too.)

Anonymous said...

My question is, if Google's modus operandi was to acquire the information by billing codes and this (we know) is inaccurate; why did not Dr. John Halamka, CIO of BIDMC, who is both a physician and a health IT guru, inform them that this is inaccurate? Also, don't forget the inaccurate data emanated from BIDMC's own inaccurate records. Don't only blame Google for this - as noted in my comment on THCB, why didn't someone like Dr. Halamka actually transfer a patient record to Google Health and TEST THE SYSTEM before forcing e patient Dave to have to do their dirty work for them??!!

bev M.D.