Sham Peer Review Issue Goes Mainstream. WaPo: VA Physicians Fear Sham Peer Review

The paper's words this time, not mine:

From the Washington Post, "VA docs concerned about retaliation", June 12, 2014, http://www.washingtonpost.com/blogs/federal-eye/wp/2014/06/12/va-docs-concerned-about-retaliation/:

Retaliation from management is a real concern among Department of Veteran Affairs (VA)  employees ...  James Martin, a physician and a representative of the American Federation of Government Employees National VA Council, told the gathering  that sham peer reviews are a problem in the department. In a later interview, he elaborated, saying, “orchestration of facts” related to issues involving contact with patients [in other words, fabricating stories about substandard patient treatment by physicians, cherry-picking minor incidents and exaggerating them, etc. - ed.] is an issue at some facilities.” Sham reviews, he explained, can be used when management wants to replace or punish a doctor.

Retaliation against employee whistleblowers was again the subject of discussion during Thursday’s hearing of the House Veterans Affairs Committee.

Further amplifying the point:

... During the hearing, Republicans Jeff Miller (Fla.) and Dan Benishek (Mich.), both of whom spoke to the NAVAPD conference, asked Robert L. Jesse, the department’s acting under secretary for health, about reports that VA employees were instructed not to talk with members of Congress.

Benishek, a physician and former VA employee, said agency doctors have told him they are “reprimanded and have this retribution if they try to change the system.”

Read the whole article at the link above.

Then, read more on sham peer review at the American Association of Physicians and Surgeons (AAPS) resource site at http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/.

A typical scenario is described like this:

A conscientious doctor reports a quality care problem or patient safety problem to the hospital administration. This might be anything from an anesthesiologist falling asleep during surgery to a malfunctioning piece of equipment which places patients at risk for harm.

Instead of fixing the problem, some hospitals misuse the peer review process to attack and silence the physician whistleblower.

The hospital administration and unethical physician collaborators then search for some pretext upon which to attack the physician whistleblower. This might involve the hospital bringing trumped up charges against the physician or it might involve bringing totally false and/or fabricated charges against the physician. The truth and the facts do not matter in a sham peer review in the hospital since the hospital controls the entire process.

The hospital then goes through the motions of providing a hearing to the accused physician, which they call “fair,” yet the outcome of the hearing is predetermined. The physician’s due process rights are often utterly trampled. At the conclusion of the process, the physician’s privileges to practice at the hospital are terminated. The physician is reported to the National Practitioner Data Bank, and the physician’s career is essentially over. Once a physician receives a negative report in the National Practitioner Data Bank, it is unlikely that physician will ever work in any hospital again anywhere in the nation.

Sham peer view affects all physicians, not just public-sector ones.

It does not help patients when physicians, their supposed advocates, are cowering in fear over destruction of their careers for being "whistleblowers" (for which a better term might be "corporate integrity agents").

Finally, I think this fear helps explain the relatively low levels of complaints about bad health IT, on which hospital executives invest billions of dollars and their reputations.

-- SS

A Nurse's Union, National Nurses United, Takes On Bad Health IT

National Nurses United (http://www.nationalnursesunited.org/), a nurse's union, takes on bad health IT with both satire and seriousness:

Hey dude!  I'm your highly-cost effective computer technician Steve.  Tell me what's hurtin' and I'll program it into Frank, our computerized doctor and nurse replacement. (YouTube video at https://www.youtube.com/watch?feature=player_embedded&v=YthF86QDOXY.)

See their page at http://www.nationalnursesunited.org/site/entry/insist-on-an-rn

I note that nature abhors a vacuum, and since medicine's watchdogs (e.g., FDA), physicians and their organizations, the Medical Informatics community and others who know better have left a deep vacuum over health IT problems, I'm glad unionized nurses have stepped up to the plate.

-- SS

EHR Story for Mother's Day 2014: Even The Formerly Simple Act Of Giving IV Fluids in ICU's Can Kill Babies. But's Let's Be Objective and Happy!

[Note to the humorless:  this post is satirical and sardonic to make a very serious point about the perversity of downplaying/ignoring health IT risks, issues too often ignored by those who know better.  If you don't like satire, don't read it.]

I've been critiqued for posting in too gloomy a manner for some's taste, even those who like me are in the Medical Informatics field.  For example, in the Feb. 2013 Kaiser Health News article "Health Technology’s ‘Essential Critic’ Warns Of Medical Mistakes" at http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx:

... Many say he comes on too strong. Even admirers cringed when he began blogging about the 2011 death of his mother, which he blames in a lawsuit on a computer error that allegedly caused Abington Memorial Hospital to overlook a key medication. (Both he and the hospital said they couldn’t comment on a pending suit.) Personalizing his campaign, some thought, made him seem less objective.

Of course, if a close relative of these unnamed "many" were killed by, say, a drunk driver (something this unobjective group of mothers takes seriously:  http://www.madd.org/), or if their child were abducted and decapitated (http://en.wikipedia.org/wiki/Murder_of_Adam_Walsh), or if something like this event (https://www.youtube.com/watch?v=55XJivhjB4U) happened, their response would surely be "oh well, stuff happens, let's all be 'objective', not 'personalize' things, not advocate with our personal stories, and above all, be happy!   

 

I really do admire the unnamed "many" for their ability to detach, so am presenting the following story of "anecdotal" patient harm to a child in a pediatric ICU in the spirit of happiness, joy, and Mother's Day love!

Here's the event we should all be happy about, reported via FDA - I note the FDA's said these devices are not "sufficiently risky" to warrant a high level of their attention even though they secretly admitted in an internal memo that there's no way to really know te true level of risk and harm (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html), so clearly they're all a really jolly bunch:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=117690

FDA MedSun report

Type of device: medical device data system
Device brand name: PowerChart
Device manufacturer's name: Cerner Corporation
Date of this report: (mm/dd/yyyy) 03/04/2014

Describe the event or problem:    

Medication Error. This event was related to Health Information Technology. Specifically, the manner in which the system processed an order for free water replacement. Order was intended to be 20ml/hr for 6 hours for a total of 120ml. It was a 1000 ml bag so first they put 20ml/hr which would have defaulted the infuse over time to 50 hrs. They tried to change the infuse over to 6 hours which then changes the ml/hr rate to 167 ml/hr. They did not notice this had changed. 

Well, that's WONDERFUL!!  :-)  that the computer recalculates the flow rate for them when they change the infusion time, by paternalistically assuming that's what they wanted to do - change the RATE of infusion - when what they actually did is manually change the TIME (duration) of infusion. 

How LOVELY of some programmer to have given them this FANTASTIC convenience!!

Aren't computers wonderful!!!

Even the following should not be cause for ardent technophiles to wipe the smile from their downside-ignoring faces!!

... They did not realize that they needed to go into details tab to show the time frame so the patient got 167ml/hr instead of 20ml/hr for 6 hours. 

How obvious!!!  Every doctor, nurse, medical student and janitor knows from time immemorial knows you have to go into the detail tab to show the time frame!  (Smile)

... Order was verified by pharmacy and administered at that rate via peripheral IV. After approximately 1L of fluid had infused, patient showed seizure activity.  PICU (pediatric ICU) team called to bedside. Treatment provided for seizures and critical sodium and potassium. 

Awww ...  some seizures and critical sodium and potassium levels in the PICU.  Awww.....too bad!!!  We should be happy anyway!  For if this child died...the sacrifice would have been WORTH IT for the betterment of electronic medical records worldwide, and the parents no doubt would be flattered and joyous about their contribution to computing science.  After all, how better to figure out how to make this technology work??

After all, it takes a few broken eggs to make an omelette, and a few bumps in the road (like grave mounds) should be of little concern.

Because, remember ... w.e. c.a.r.e!

i c.a.r.e!!!!  As at U. Arizona Healthcare System, let's only use Happy Words with our patients about these systems! (click to enlarge, see http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html )

Further, we should use only Words That Work to describe the wonders of these systems in their current state!!!

Some flowers from Cerner CEO Patterson to momma to make up for her little baby having seizures and critically deranged potassium and sodium levels from those big, bad doctors' EHR mistake!

... The Cerner powerchart software system has functionality for continuous medications/fluid ordering that does not prevent "user error." 

Ut oh ... Looks like I'm going to have to be a sourpuss for just a moment and re-introduce the nasty, ill-tempered, non-objective idea of what the dastardly National Institute of Technology and Standards (NIST) calls "use error" (as opposed to "user error", A.K.A. "Blame the User",  http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html):

... The EUP (EHR usability protocol) emphasis should be on ensuring that necessary and sufficient usability validation and remediation has been conducted so that use error [3] is minimized.

[3] “Use error” is a term used very specifically to refer to user interface designs that will engender users to make errors of commission or omission. It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging [or lack of messaging, e.g., no warnings of potentially dangerous actions - ed.], misuse of color-coding conventions [see below], omission of information, etc.

Awwwwww....aren't I just mean and non-objective?

That mean doctor Silverstein's just not happy and objective!!  Bad, bad, bad man!

... When the provider orders the fluid, example is D5W, the screen opens to a "continuous details" ordering window. Within the screen, the ordering provider is presented with a preselected bag volume and type of fluid with a brownish background. They have the ability to modify bag volume but it was made this color to discourage that change by Cerner. 

Golly gee!  There's something to be happy about once again!  Brown, the universally-understood color, in any language, means "Warning, do not change this value, it could kill someone!!!" See how GOOD this technology really is!!!  Why use alerts and confirmation dialogs when a mere COLOR like brown suffices!!

... The rate and "infuse over" fields are a yellow color to show that they need to be completed. The intent [of the programmer, clearly an expert in human-computer interaction and communication by color and smoke signals - ed.] is for an ongoing continuous fluid and not to limit the time. 

Golly Gee Times Two!  Yellow, the absolutely universal color for "Warning, you need to complete this to prevent killing someone!"  

Yellow!  Don't you just think every time you see this color that "warning, you need to complete data entry to avoid killing someone?  Who needs WORDS?

It's all so CLEAR!!!!

... Providers can misinterpret this field to mean the length of time they want the order to infuse over, when the system intent for that field is to be the system-calculated length of time until the next bag supply will need to be sent to maintain the continuous infusion. 

See how simple!!!!   Isn't it OBVIOUS!!!!

The completed fields turn white. Cerner does not have an intermittent fluid administration order [who the hell needs that, says Cerner and the hospital executives who bought this package for the PICU!! Never a need for that in ICU's!! - ed] so providers are expected to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, they may inadvertently order a higher rate than intended.

Ha ha!  Those silly doctors can't even figure out a simple thing like that!!  What stooges they are!!

NYUK NYUK NYUK ... Hey Moe!!  Those silly doctors and nurses cannot understand the simple fact that Cerner does not have an intermittent fluid administration order so providers are expected to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, they may inadvertently order a higher rate than intended. 

See how much FUN health IT problems can be?  After all, in this ANECDOTAL case, all that happened was:

The device(s) may have caused or contributed to: Potential for patient harm, Serious Injury

But nobody died of this particular problem (that we know of), so this technology is SAFE!!!!

Happy mother's day!!!

--------------------

Additional not-so-funny thought:  depending on brown, yellow etc. instead of clear, written alerts/warnings, plus the fact that the system likely "knew" the weight of the child and should have alerted that the infusion of a liter was a very dangerous thing, reflect Bad Health IT on its face:

Bad Health IT ("BHIT") is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  

Had I been a pre-marketing tester of this system working for FDA, those fluid-ordering characteristics would have been changed before the system would have been released to market.

Oh, wait ... there is no premarketing testing process for health IT, and FDA, via advice from the FDASIA committees as in the linked FDA-related post above, writes that none is really needed.

And who wants to damage TRUE INNOVATIONS like this - turning something that takes 5 seconds for a clinician to write, "D5W, 20 ml/hr x 6 hrs" (meaning dextrose 5% in water, 20 milliliters per hour for 6 hours) into a cryptic and muddled exercise with tabs, colors and numerous caveats - via regulation?

-- SS

Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.

Bad health IT is defined at my Medical Informatics academic site (http://cci.drexel.edu/faculty/ssilverstein/cases/) as follows:

Bad Health IT ("BHIT") is health IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

Health IT is unregulated, and Bad Health IT results in patient injuries and deaths.   This is unarguable from the data cited in this post and related posts I've linked to.  The levels of harm are unknown.

At my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html) I observed how the FDA bent over backwards to avoid regulating Electronic Medical Records systems and other healthcare IT systems:

To recap that post:

Out of one side of their mouth FDA wrote this:

... products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.

Products with health management health IT functions are of sufficiently low risk and thus, [even] if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.

While out of the side of their mouth that was not intended for public viewing, discovered by investigative reporter Fred Schulte, they wrote this:

...In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and impedes a more comprehensive understanding of the actual problems and implications.
 

FDA is thus claiming "we know what we non-publicly concluded it is not possible to know, and Health IT is not worth regulating ... even in face of dangers we do know" (e.g., see the alarming ECRI Institute data at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

Note that everyone who needs medical care (which is. essentially, everyone) is increasingly exposed to these electronic products with health management heath IT functions, against their will and without any informed consent processes.  The only people exposed to E-cigarettes are those who willingly buy and consume them.

With E-cigarettes, however: 

CBS/AP  April 24, 2014 
FDA: Ban sales of electronic cigarettes to minors 

http://www.cbsnews.com/news/fda-ban-sales-of-electronic-cigarettes-to-minors/

WASHINGTON -- The federal government wants to ban sales of electronic cigarettes to minors and require health warning labels and approval for new products under regulations being proposed by the Food and Drug Administration.

Wonderful.  How thoughtful.  (E-cigarettes are plastic or metal tubes, usually the size of a cigarette, that heat a liquid nicotine solution instead of burning tobacco. That creates vapor that users inhale.)

While the proposal being issued Thursday won't immediately mean changes for the popular devices, the move is aimed at eventually taming the fast-growing e-cigarette industry.

The agency said the proposal sets a foundation for regulating the products but the rules don't immediately ban the wide array of flavors of e-cigarettes, curb marketing in places like TV or set product standards.

Any further rules "will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits," Commissioner Dr. Margaret Hamburg said.

(Perhaps the E-cigarette industry hasn't figured out who to pay off yet?)

... "By being able to regulate e-cigarettes, we'll get a lot more information about what's in them, how they're made and we're already studying e-cigarettes in terms of how they're being used and what are their implications for health," Hamburg told CBS News.

"At the present time, when we can't regulate cigarettes, it's like they wild, wild West" she said. "Companies can do anything they want. They can market in ways that they want. ... Unless they make a therapeutic claim that it is a product for actual cessation of nicotine use, we can't regulate them. If they make a therapeutic claim, we can regulate them as a medical product."

The "Wild, wild west" is a perfect descriptor of the health IT market.  And claims of benefits?  How about some 'Words that Work?'  (http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html)

Hamburg stressed to CBS News that, "Until we have the authority to regulate e-cigarettes, we cannot provide the information that the American public wants about the relative risk and safety of these products. ... We cannot put in place certain restrictions that might be appropriate with respect to how the products are made, the kind of flavorings, the kind of marketing, etc. So we see this as really a crucial first step."

The health IT industry has special accommodations in that regard that the E-cigarette company lawyers need to closely examine.

Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn't contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. However, there's not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it's unclear how safe they are.

It's undeniably unclear how safe clinical IT devices are, either.  The ECRI Institute, for instance, found 171 mishaps in 9 weeks at 36 hospitals voluntarily reported, leaving 8 patients harmed and possibly three of them dead.   (A likely far more than serous problem than GM cars with defective ignitions that killed ~13 in a decade...)   The FDA found many injuries and several deaths in their own self-admitted limited dataset as well.  (See FDA Internal Memo on HIT risk at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html).

... Companies also will be required to submit applications for premarket review within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. That would mean companies would have to submit an application for all e-cigarettes now being sold.

There is no premarket review of clinical IT of the types categorized by FDA as "with health management heath IT functions" as above, even if those devices meet the statutory requirements as a medical device that falls under the Food, Drug & Cosmetic Act.  These systems increasingly mediate and regulate every transaction of healthcare.

E-cigarettes, however, are a major concern that are being reviewed in earnest?

Unbelievable.

-- SS

DISCLAIMER:  I neither use tobacco products in any form nor E-cigarettes, never did, and have no conflicts of interest of any kind with either the tobacco or E-cigarette industries.

Senate Majority Leader Harry Reid on Bad Health IT: "People Aren’t Educated on How to Use the Internet"

The ultimate "blame the user" excuse for bad health IT comes from, of all places, Senate Majority Leader Harry Reid:

Washington Free Beacon
http://freebeacon.com/issues/harry-reid-people-arent-educated-on-how-to-use-the-internet/
March 26, 2014 1:16 pm

Senate Majority Leader Harry Reid (D., Nev.) said the fault of struggling to sign up on the Obamacare exchanges didn’t lie with the faulty website, but with the people who weren’t “educated on how to use the Internet.”

Explaining the reasoning behind the latest Obamacare delay, Reid said too many people just didn’t know to use their computer properly and needed more time. Apparently, it had nothing to do with the well-documented failings of the website that have embarrassed the White House for months.  [Really?  What an amazing theory about IT difficulties - ed.]

“We have hundreds of thousands of people who tried to sign up who didn’t get through,” he said. “There are some people who are not like my grandchildren who can handle everything so easily on the Internet, and these people need a little extra time. It’s not — the example they gave us is a 63-year-old woman came into the store and said, ‘I almost got it. Every time I just about got there, it would cut me off.’  

Obviously due to user error, not due to poor health IT.

We have a lot of people just like this through no fault of the Internet, but because people are not educated on how to use the Internet.”

It's not the software designer's or website's fault, it's the fault of Americans, most of whom are dummies and who should know how to get around bad health IT's flaws. 

Wow.

That's why physicians complain about health IT too, no doubt.  They're dummies.

Maybe Mr. Reed should speak with the inventor of the Internet, former Veep Al Gore, about that.  Mr. Gore can perhaps write a better "Internet Instruction Manual for Dummies."

(I'll bet most of the dummies who "do not know how to use the Internet" have no problems using Amazon.com or eBay.)

-- SS

Medical Malpractice Insurer CRICO Challenges "EMR Complacency" - Or Do They?

In my Feb. 28, 2014 post "Malpractice Claims Analysis Confirms Risks in EHRs" (http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html) I pointed out that the annual medical malpractice claims related to health IT received by the insurer for the Harvard medical community, one of the world's best users of health IT, might represent a significant percentage of the annual med mal claims in the state of Massachusetts.  Many involved serious injury.

I also pointed out that the claims themselves represent only a small fraction of total incidents of med mal-related harms (including due to IT), due to the economic realities of med malpractice litigation.

In the press release reproduced below, CRICO writes of poor integration and "design deficiencies" - bad health IT - and that "there has been no apparent leader in this field making a concerted effort to design the next generation of EMRs with the physician in mind", and that they hear "significant frustration from physicians related to their experience with EMRs." 

However, CRICO does not write of the reasons why these issues are as prevalent as they are.

Their claim appears to be, in essence, that these problems will be solved through dialog and "conversation" - in other words, appeals to corporate altruism.

Why this industry receives special accommodation even from those who have to pay for their mistakes is beyond me:

CRICO Challenges EMR Complacency 
http://www.rmf.harvard.edu/EMR 
February 6, 2013

In a recently released video, CRICO offers a vision of how EMRs of the future might improve health care safety for both patient and physician. 

Press Release:  Cambridge, MA — CRICO, the patient safety and medical professional liability company serving the Harvard medical community, has produced a video that puts forth a future vision of how Electronic Medical Records (EMRs) might be embedded into the physician workflow in a manner that would improve health care delivery. CRICO has based the dramatization on real malpractice cases. Through combined analysis of how harm can come to patients from flawed encounters with providers, and conversations with medical and technological visionaries across the country, the video integrates various scenarios into an idealized patient/physician encounter. 

Hearing significant frustration from physicians related to their experience with EMRs, CRICO was inspired to envision a way in which they might be better integrated into  the clinical workflow. This would allow the EMR to offer some relief to physicians and nurses who face seemingly insurmountable challenges of time and data management.

Luke Sato, MD, chief medical officer and senior vice president for CRICO said, “The impetus behind this video was to facilitate a dialogue among health care professionals—physicians, IT, hospital administrators—about why we aren’t making better progress in the development of EMRs.  Through analysis of medical malpractice claims, we have line of sight to design deficiencies in the EMR that contribute to claims. The best technological design is one that is integrated seamlessly into one’s workflow. The current EMR is passive—the physician has to actively look for data instead of the technology anticipating what the physician needs to act on.”

Opinions within the health care industry are diverse about EMRs but there has been no apparent leader in this field making a concerted effort to design the next generation of EMRs with the physician in mind. In addition to a need for standards across systems, the manual data entry of today’s EMRs adds to the burden of already time-pressed physicians.

The film was created as a collaborative effort between CRICO’s Luke Sato, MD and David Ting, MD, associate medical director for information systems at Massachusetts General Physicians Organization, who acted as an expert resource for script development and video production. Ting said, “The actual purpose of the video is to ask whether we might intelligently prioritize today’s choices to move our institutions toward improved patient care and improve provider and practice work-life experience.”

While most of the technology that is used in this dramatization is available today, other elements are further out. CRICO’s future vision, as depicted in the video, is meant as a launching pad to begin the conversation about how new technologies can provide a way to enable EMRs to enhance, streamline, and make safer the patient-physician encounter.

Dr. Ting has encouraged his colleagues at MGH to view the video and share their feedback. The physician reaction has elicited a variety of reactions and diverse feedback ranging from “cool, efficient, saves time, and improves outcomes” to “I don’t want voices interfering with my patient interactions.”  The video is available for viewing on the CRICO website, www.rmf.harvard.edu/EMR. 

ABOUT CRICO

For more than 30 years, CRICO has been the patient safety and medical professional liability company owned by and serving the Harvard medical community.

CRICO is an internationally renowned leader in evidence-based risk management, proudly serving more than 12,000 physicians (including residents and fellows), 22 hospitals, and nearly 209 other health care organizations.

They see the problems but do not engage the human reasons for the problems, including generic leadership, conflicts of interest, incompetence, territoriality, profit motive, and the other ills that we write of till our faces turn blue at Healthcare Renewal.

In other words, their "challenge to EHR complacency" is about as powerful as our challenges have been to Vladimir Putin regarding Crimea and Ukraine.

Perhaps when the payouts become even more severe, insurers will think it a good idea to stop 'making nice' with an intrusive and unregulated industry that has invaded clinical affairs like a bull in a china shop.

Can we please, pretty please dialog for a bit about your breaking the dishes?

-- SS

On Hypervigilance Due to Bad Health IT: "Texting While Doctoring: A Patient Safety Hazard"

An Opinion piece "Texting While Doctoring: A Patient Safety Hazard" appeared in the Annals of Internal Medicine of 3 December 2013, authored by Christine A. Sinsky, MD and John W. Beasley, MD.  Dr. Sinsky is known to me to be what some would call a "heatlhcare IT iconoclast" (more accurately represented by the term "healthcare IT gadfly/realist" IMO).

In the piece the authors comment on the distractions caused by the technology, leading to doctors missing important cues in the exam room and to and impaired problem-solving.  This is part of a larger phenomenon that has been called "skill-degrading" or "de-skilling", e.g., see my April 16, 2010 post "Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee" at http://hcrenewal.blogspot.com/2010/04/health-information-technology-basics.html).  

These effects are likely to be further worsened as more and more clerical tasks such as order entry, the authors point out, get shifted to medical professionals.  To new readers: note that computerized order entry is often a complex and convoluted process; the CPOE systems are most decidedly NOT mere "typewriters for orders."  See, for instance, part 6 of my series on "Mission-hostile health IT" at http://hcrenewal.blogspot.com/2009/02/it-makes-healthcare-easier-is-this.html.

Most of the Annals article is available as a free preview at http://annals.org/article.aspx?articleid=1784295 as of this writing and is worth reviewing.

Article preview, click to enlarge

I found one passage in particular striking, though.  In my ongoing discussions with computer scientist/informaticist/polymath Dr. Jon Patrick at U. Sydney (http://www.healthll.com.au/?page_id=440) , the issue of hypervigilance necessitated by bad health IT came up, and we arrived at the definition of same seen at my teaching site at http://cci.drexel.edu/faculty/ssilverstein/cases/:

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

Note this passage in Dr. Sinsky and Beasley's opinion piece:

"I am always multitasking ... I am entering orders, checking labs, downloading information while I talk to the patient.  It requires chronic hypervigilance, which is exhausting and demands conscious effort to stay in the 'present' with the patient" (Day S., Personal communication.)  Click to enlarge.

I don't know if Dr. Day had seen my materials, but I suspect the exhausting hypervigilance is all too common, just not much publicized due to the secretive, closed, retaliatory-towards-whistleblowers nature of the healthcare IT sector.

I ask:  is this what we really want, in pursuit of some uncertain cybernetic miracle?

I note that the healthcare IT experiment (and the technology is experimental), long usurped from the Medical Informatics pioneers who trained me and put in the hands of commercial interests and those of a mercantile/manufacturing/management computing background, is increasingly a failure.

-- SS

Today's Bad Health IT Systems: More Dangerous Than Paper?

I believe in 2013 that they are.

(Definition of bad health IT is here:  http://www.ischool.drexel.edu/faculty/ssilverstein/cases/)

I recently posted about two "glitches" in a major EHR seller's clinical systems, Siemens Healthcare, affecting safety-critical functions of medication reconciliation and medication ordering.

• Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?

• Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2

Considering these, plus the many "glitches" reported by the only EHR seller who does so via FDA's MAUDE database (see here: http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and the others posted at this blog at query link: http://hcrenewal.blogspot.com/search/label/glitch, the following issue needs serious consideration by policymakers.

Namely, the issue that enterprise electronic medical command-and-control systems, which today's "EHRs" in reality are, are on their face more risk-prone than the paper systems they are replacing.

The "glitches" reported above are clearly the tip of the iceberg due to industry norms of secrecy, the absence of most of the industry in reporting to FDA MAUDE or anywhere, and my limited sources of information.  It is likely the true level of "glitches" in live EHR/clinical IT installations is far, far higher  - conservatively, I believe, at least two orders of magnitude.

Workarounds to IT "glitches" such as recommended in the Siemens bulletins at the aforementioned posts cause hospital officials to have to  reliably get the notices to all users of the systems, including medical students, nurses, physicians and allied health professionals.

The workarounds also cause users to:

1)  have to deviate from habits of use acquired in training and active use of the systems in question;
2) remember, without fail, to deviate from habits of use acquired in training and active use of the systems in question, in effect giving them the responsibility of caring for sick patients and for "sick" information technology;
3) keep in mind any other extant workarounds that exist waiting for "fixes"; and
4) be constantly on guard for information storage failures.

In fact, the recent Siemens "glitches" and workarounds represent a clear danger to patient safety.  If these were more conventional medical devices, they'd be recalled.

See my Dec. 14, 2011 post "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death" (http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html) and July 23, 2012 post "Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems"(http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html) for examples where health IT defects similar to the Siemens issues were, in fact, recalled.

Further, with paper records or tangible images, a page or image can be lost, or it can be illegible.  In the case of lost, in any quality paper record keeping system the information stewards or others using the paper (e.g., office staff or ward clerks) will generally note the absence and act accordingly.  Further, illegible notes or orders will most often be recognized as illegible and result in attempted clarification or other corrective actions.

On the other hand, when electronic systems:

1)  lose modified information en masse as in the Siemens examples but keep the old, or
2)  when outright errors such as en masse truncation occur (as in the thousands of prescriptions whose long-acting suffixes were cut off at Lifespan in Rhode Island, see "Yet another health IT "glitch" affecting thousands" here: http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or
3)  images are lost (see "Potential Image Loss in GE Centricity PACS" here:  http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html) without warning-

- There are no "flags" that the obsolete, truncated or missing information is erroneous.

What remains is perfectly legible, perfectly convincing and perfectly deceiving.

Electronic healthcare information systems on their face create more risk than paper record systems.  Further, the problem with "bugs" and "glitches" will not go away with today's industry models of "hiring down" and lack of regulation.  Every new upgrade or patch is suspect for introducing new bugs.

Paper does not suffer these issues, unless disappearing ink is used to cross out the old and add new information ...

Not that I am advocating for a return to 100% paper, but certain critical functions probably are best left to paper.  Further, hundreds of billions of dollars can certainly buy:

1)  a lot of Health Information Management professionals to perform continuous QA of paper,
2)  a lot of document imaging systems to make the paper records available anywhere, anytime they are needed, and
3)  a lot of data entry personnel to relieve clinicians of clerical burdens so they may use their valuable experience more productively, as guest poster Howard Brody points out at http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html.
4)  a lot of sensible regulation of this industry's product quality.

-- SS

On EHR's: See No Evil, Hear No Evil, Speak No Evil: Part 2

Part 1 is here.

This is the second a series of posts I plan on the issue of "See No Evil, Hear No Evil, Speak No Evil" regarding EHR's.

Frequent reminders are needed by all stakeholders, I believe, to think critically about, and take with a big grain of salt, effusive praise by key opinion leaders, politicians, etc. about health IT, and accompanying attempts to deride those critical of the technology, to counterbalance ongoing HIT hyperenthusiasm.

The following quote comes from a May 2010 post "David Blumenthal on health IT safety: nothing to see here, move along":

Blumenthal, at the time Director of ONC at HHS had reportedly stated that:

http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented

... [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 [rapidly and on a national scale - ed.] could impede patient safety," he said.

The "nothing" includes 44 injuries voluntarily reported to FDA and 6 reported deaths in an enviroment where few know where to report such things and where no reporting requirements exist, and a statement from the head of CDRH at FDA that due to systematic impediments to accurate knowledge the known figures likely are a small fraction ("tip if the iceberg") of the actual occurrence.

The FDA internal memo on HIT risk brought to the forefront by investigative reporter Fred Schulte and downloadable here spells out the FDA impediments in some detail.  It is not reasonable to believe the head of ONC and an entire ONC committee would have been entirely unaware of the issues.  (Later studies are even more concerning, e.g., by IOM and ECRI, as at this blog.)

Yet an ONC committee under his leadership recommended "full steam ahead" anyway.

In the corporate world that is known as gross negligence:

Gross negligence is a conscious and voluntary disregard of the need to use reasonable care, which is likely to cause foreseeable grave injury or harm to persons, property, or both. It is conduct that is extreme when compared with ordinary Negligence, which is a mere failure to exercise reasonable care.

There is nothing to discuss, nothing to debate about that.

Claims about HIT beneficence this need to be taken with a big grain of this.

The ongoing "what? me worry?" attitude of the pundits needs to be counterbalanced.  This series is a small effort (the industry has a lot more control of the channel than I) to catalog the words and call out the pundits in a readily-found format.

More to come in this series.

-- SS

On EHR's: See No Evil, Hear No Evil, Speak No Evil: Part 1

This is the first of a series of posts I plan on the issue of "See No Evil, Hear No Evil, Speak No Evil" regarding EHR's.  Frequent reminders are needed by all stakeholders, I believe, to think critically about, and take with a big grain of salt, effusive praise by key opinion leaders, politicians, etc. about health IT, and accompanying attempts to deride those critical of the technology, to counterbalance ongoing HIT hyperenthusiasm (e.g., link).

In face of growing evidence of risk and adverse outcomes of bad health IT from multiple sources and organizations (such as this, as just one example), growing advice on risk remediation from government (such as here), and mass privacy violations (see the multiple posts under this query link), it might also be entitled a series on what health IT hyper-enthusiasts "knew, should have known, or should have made it their business to know."

Let's start out with an extract from a post I wrote on June 29, 2003 entitled "Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?". At the time Leavitt was head of CCHIT, a tester and MU compliance/safety certifier of electronic health records systems: 

... The head of CCHIT, Mark Leavitt, has penned the following at iHealthBeat: 

June 19, 2009 - Perspectives 

Health IT Under ARRA: It's Not the Money, It's the Message

by Mark Leavit  

... Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, individuals with a deeper-seated "anti-EHR" bent emerged. Their numbers are small, but their shocking claims -- that EHRs kill people, that massive privacy violations are taking place, that shady conspiracies are operating -- make stimulating copy for the media. Those experienced with EHRs might laugh these stories off, but risk-averse newcomers to health IT, both health care providers and policymakers are easily affected by fear mongering.

"Laugh these stories off?"  That was, and is, simply perverse.

Ironically, this statement was written less than a year before my own mother was seriously and fatally harmed as a result of a health IT-related error.
 

On EHR's:  See No Evil, Hear No Evil, Speak No Evil

While I don't proffer claims of "shady conspiracies" (international health IT expert Dr. Richard Cook explains that in a recent guest post "Dr. Richard Cook on the Health IT Sector's Ills"), I do proffer alternate explanations including arrogance, Radical Solutionism, and this.

More to come in this series.

There are many more statements like this one already on this blog, and elsewhere.

-- SS

Note:  Part 2 is here.

Wisdom from the Medical Journal of Oz: "Good HIT and bad HIT"

The recognition and partitioning of "good health IT" from "bad health IT" is now a mainstream meme.  I have few comments about this new article; it reflects views frequently expressed here at Healthcare Renewal (indeed, one of its references is to this blog and this author):

Good HIT and bad HIT
Jon D Patrick and Susan Ieraci
Medical Journal of Australia 2013; 198 (4): 205.

First and foremost, do no harm. Second, do some good

One of the key issues for high-volume, high-risk workplaces like hospital emergency departments (EDs) is the struggle of conflicting aims. While hospital managers need information systems for data collection and storage, clinicians need efficient clinical documentation, data retrieval and order-entry systems that save time rather than steal it from the patient. The work of clinicians is aided by reliable data but impaired by the delays of real-time input, difficult system navigation, suboptimal presentation of information, and other problems in the user experience of health information technology (HIT).1

Mohan and colleagues’ study of the impact of an electronic medical record information system on ED performance had some limitations.2 It was retrospective and unable to control for all confounders, and therefore could only show a correlation with ED delays, not causation. However, the premise for the study delivers an important message — the work required to use the information system was perceived by the ED staff to directly conflict with time spent with patients.

Another study has shown that the same electronic medical record information system is perceived to have had a negative impact on the care of patients, as well as the productivity and morale of staff, in six EDs in New South Wales.3 The need to be hypervigilant about the accuracy of the information supplied by the electronic health record compounds an already stressful clinical environment, which in turn leads to resentment towards the technology and the people who have imposed it. This makes it “bad” HIT. Unless this is corrected, HIT efforts will overuse precious health care resources, will be unlikely to achieve claimed benefits for many years to come, and may actually cause harm.4,5

The large HIT corporations produce a type of technology that is best categorised as enterprise resource planning (ERP), which has its roots in the manufacturing industry. It is based on the idea that all processes within an organisation can be standardised, and that all processes of the same type should have their information modelled and processed in the same manner. If this high degree of standardisation were considered the best way to process and model information derived from clinical activity, then ERP would be a favoured technology to adopt, as has happened in many places.

However, there is an alternative, almost contradictory, perspective on the nature of clinical work: that it is non-deterministic and performed by a group of diverse staff working in an ecologically stable network of people that has to respond to diverse medical needs and diseases. The ecology model accommodates staff joining and leaving the process, with differing needs emerging at different times, so that the other individuals in the network have to adapt and modify their behaviour and improvise in an unpredictable manner. Amid all this variability is the ever-demanding imperative to improve the processes of care and attention to the patient, while also increasing staff productivity.6

Where the ERP model has been imposed in the clinical setting, staff may be coerced into an approach to their work that is at odds with established best practices. This could only be considered “good” HIT if it brought greater staff productivity with at least no loss (and, preferably, improvement) of patient safety and services and staff morale.

It is not enough just to identify problems: effort must be invested in transforming bad HIT into good HIT. This process must identify and optimise all the operative factors: human behaviour, system design, equipment performance, skills of the IT participants, and the operational policy framework.7 Good HIT should include clinician control of the interface design for content, dataflow and workflow. It includes the ability to change the system in real time, and it incorporates inbuilt data analytical capability, natural language processing, and native interoperability and clinical coding.8 Finally, there must be an appropriate opportunity to test systems for useability, effectiveness and suitability before their release.

There must be a move away from standardised processing models and towards improving the user experience in the clinical setting. Clinicians should not have to shoehorn their activity into predefined, externally imposed work processes that do not reflect actual activity and will not improve efficiency. A true patient-focused system aligns all its components towards the same aim. Like a good clinician, good HIT does no harm — to patients or staff.

American medical / HIT journals are perhaps a bit too beholden to industry to directly commit such health IT heresy.  Thank the stars those Down Under are a bit more bold.

-- SS

Bad Health IT -Yet Another Health IT 'Glitch' - Potential Image Loss in GE Centricity PACS; ECRI Again Reports Health IT a Top Ten Hospital Risk

From my definition of bad health IT (BHIT) at this link:

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  

Considering the problem of lost data (lost x-rays) that affects not one, but two versions ("versions 3.x and 4.x and higher") of a common GE PACS (radiology image management) system, as in the attached memo to hospital radiology and IT executives, one might ask:

• How long has this been going on before this 'glitch' was discovered? 

• What validation and safety testing does GE use before releasing its health IT to production? 

• Why was it discovered in several successive versions of PACS systems being used on live patients, instead of in laboratory testing?

• How many delayed diagnoses, injuries and/or deaths might have occurred as a result of this "disappearing image" bug?

• What is the likelihood this "workaround" will be uniformly adopted in short order?  

• What levels of hypervigilance, stress and increased likelihood of error will this temporary "workaround" engender?

• When will it be fixed in all implementations worldwide?

 Beware disappearing x-rays.  Make sure every system user performs this workaround, too (click to enlarge).

Page 2 (click to enlarge)

It's not as if missing x-rays are a trivial matter.  One routine x-ray lost to followup resulted in the needless and rather horrible death of an infant, and a $1.5 million settlement, as at the June 2011 link "Babies' deaths spotlight safety risks linked to computerized systems" (case #2).

Patient safety is being compromised.

Lack of regulation of health IT, and lack of reporting and accountability, needless to say, are major contributors to the prevalence of BHIT.

I also note for several years running, including in the latest report of 2013, the ECRI Institute (an independent tester of healthcare technology) reports health IT-related problems as among the top ten technology problems in hospitals (link to report):

...Five of the top 10 hazards explained in ECRI Institute’s [2013] report are:

    1.  Alarm hazards
    2.  Medication administration errors using infusion pumps
    3.  Unnecessary radiation exposures and radiation burns during diagnostic radiology
         procedures
    4.  Patient/data mismatches in EHRs and other health IT (HIT) systems
    5.  Interoperability failures with medical devices and health IT systems

Three of the ten topics on the 2013 list are directly associated with the still-maturing [i.e., experimental - ed.] health IT field where the interplay between complexity and effectiveness and potential harm is most evident; several of the other topics are peripherally related to HIT issues.

“The inherent complexity of HIT-related medical technologies, their potential to introduce new failure modes, and the possibility that such failures will affect many patients before being noticed—combined with federal incentives to meet Meaningful Use requirements—leads us to encourage healthcare facilities to pay particular attention to health IT when prioritizing their safety initiatives for 2013,” says James P. Keller, Jr., vice president, health technology evaluation and safety, ECRI Institute.

The hazards included in the 2013 list, published in the November 2012 issue of ECRI Institute’s Health Devices journal, met one or all of the following criteria: it has resulted in injury or death; it has occurred frequently; it can affect a large number of individuals; it is difficult to recognize; it’s had high-profile, widespread news coverage.

-- SS

New York Times: "The Ups and Downs of Electronic Medical Records"

The "downs" of health IT have rarely been presented in a prominent public forum.

After a recent Center for Public Integrity series and New York Times story on EHR-related upcoding, the New York times does so again.  This blog is cited:

October 8, 2012
The Ups and Downs of Electronic Medical Records
New York Times
By MILT FREUDENHEIM

The case for electronic medical records is compelling: They can make health care more efficient and less expensive, and improve the quality of care by making patients’ medical history easily accessible to all who treat them.

Small wonder that the idea has been promoted by the Obama administration, with strong bipartisan and industry support. The government has given $6.5 billion in incentives, and hospitals and doctors have spent billions more.

But as health care providers adopt electronic records, the challenges have proved daunting, with a potential for mix-ups and confusion that can be frustrating, costly and even dangerous. 

"Dangerous" is the concept that has been most lacking in public debate.  Through my many years of writing on health IT difficulties and more recently my legal work, I know of injuries and deaths caused or contributed to by bad health IT (e.g., see here and here).  I experienced a tragedy in my own family as well.

The New York Times has done a significant public service in mentioning this critical issue, long hushed by the hyper-enthusiasts to whom computers seem to hold more rights than people, and to whom plans for a "cybernetic healthcare utopia" override long held principles and standards for human subject research protections.

Some doctors complain that the electronic systems are clunky and time-consuming, designed more for bureaucrats than physicians. Last month, for example, the public health system in Contra Costa County in California slowed to a crawl under a new information-technology system. 

Doctors told county supervisors they were able to see only half as many patients as usual as they struggled with the unfamiliar screens and clicks. Nurses had similar concerns. At the county jail, they said, a mistaken order for a high dose of a dangerous heart medicine was caught just in time. 

That scenario, not at all unique (e.g., see New York Times, "Designed for Efficiency, New Computer Software at Health Dept. Misfires", Nov. 2010 and my comments here), is a warning that the technology needs significant work and cannot just be rammed into place.

The first national coordinator for health information technology, Dr. David J. Brailer, was appointed in 2004, by President George W. Bush. Dr. Brailer encouraged the beginnings of the switch from paper charts to computers. But in an interview last month, he said: “The current information tools are still difficult to set up. They are hard to use. They fit only parts of what doctors do, and not the rest.”

Refreshing candor that should be coming from the present ONC leader, not the two-generations-ago former incumbent.

Like all computerized systems, electronic records are vulnerable to crashes. Parts of the system at the University of Pittsburgh Medical Center were down recently for six hours over two days; the hospital had an alternate database that kept patients’ histories available until the problem was fixed. 

Those crashes are also not uncommon.  See for instance my posts on the common refrain when that happens that "patient care has not been compromised" (query link).

Even the internationally respected Mayo Clinic, which treats more than a million patients a year, has serious unresolved problems after working for years to get its three major electronic records systems to talk to one another. Dr. Dawn S. Milliner, the chief medical informatics officer at Mayo, said her people were “working actively on a number of fronts” to make the systems “interoperable” but acknowledged, “We have not solved that yet.”

Perhaps the worst example of that phenomenon is the DoD-VA interface debacle.  See my apparently popular (based on "hits") March 2010 post "VA / DoD EHR Interface Debacle: Will It Take the Luminosity Of A Dozen Supernovas To Shed Light On The Obvious About Healthcare IT?"

Still, Dr. Milliner added that even though there a lot of challenges, the benefits of information technology are “enormous” — improved safety and quality of care, convenience for patients and better outcomes in general.

Enormous?  It is quite clear that this has not been proven in the real world with large scale health IT, especially in its present form.  It may be the case that the improvements will be modest at best.  Many if not most healthcare problems may not be related to documentation at all (see my Dec. 2010 post "Is Healthcare IT a Solution to the Wrong Problem?" for instance).  Also, as I've written, a good or even fair paper record system is better for patients than BHIT (bad health IT).

In the rare event that a large-scale system goes down at Mayo, backup measures are ready, teams are called in to make rapid repairs, and if necessary “everyone is ready to go on paper,” Dr. Milliner said. 

Paper records do not unexpectedly "go down" en masse.

Reliable data about problems in the electronic systems is hard to come by, hidden by a virtual code of silence enforced by fears of lawsuits and bad publicity. A recent study commissioned by the government sketches the magnitude of the problem, calling for tools to report problems and to prevent them. 

"Omertà" is perhaps the best term of art for this form of silence...

Based on error rates in other industries, the report estimates that if and when electronic health records are fully adopted, they could be linked to at least 60,000 adverse events a year.

My own estimates are much higher if the technology and its industry are not first drastically reformed, as in my April 2010 post "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers."

The Obama administration will issue a report on patient safety issues in early November, the current national coordinator, Dr. Farzad Mostashari, said in an interview. That report was requested last year by a panel on health I.T. safety at the Institute of Medicine, a unit of the National Academies of Science.

Considering the available data is limited, as per the FDA and IOM itself (see addendum here), the report should be immediately suspect for underestimation/cheerleading if not whitewashing.

... Elisabeth Belmont, a lawyer for the MaineHealth system, based in Portland, advises hospitals to reject contract language that could leave them responsible for settling claims for patient injuries caused by software problems.

The IT industry is quite mature and no longer merits such special accommodation.  As in other industries, liability should be covered by the industry itself, not by customers (and patient victims).  See "No More Soft Landings for Software: Liability for Defects in an Industry That Has Come of Age", Frances E. Zollers, Andrew McMullin, Sandra N. Hurd, and Peter Shears, Santa Clara Computer & High Technology Law Journal, May 2005.

The institute also recommended that software manufacturers be required to report deaths, serious injuries or unsafe conditions related to information technology. So far, however, neither a new safety agency nor such a reporting system has been adopted.  Some of the largest software companies have opposed any mandatory reporting requirement.

Post market surveillance is standard for other medical device sectors and the pharma industry, as well as other mission critical IT sectors.  The continuing, remarkable special accommodation for health IT is unearned, unjustified and ethically inexplicable.

Critics are deeply skeptical that electronic records are ready for prime time. “The technology is being pushed, with no good scientific basis,” said Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog Health Care Renewal. He says testing these systems on patients without their consent “raises ethical questions.” 

In other words, while I am an advocate for good health IT, the technology is not yet ready to be pushed nationally.  Bad health IT prevails.  From my Medical Informatics teaching site:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

(I would replace the term "critic" with "realist" and/or "patient rights advocate.")

Another critic, Dr. Scott A. Monteith [who has guest-posted at this blog - ed.], a psychiatrist and health I.T. consultant in Michigan, notes that Medicare and insurance companies generally do not pay for experimental treatments that have not proved their effectiveness ... Dr. Monteith said the electronic systems were “disrupting traditional medical records and, beyond that, how we think” — the process of arriving at a diagnosis. For example, the diagnosing process can include “looking at six pieces of paper,” he said. “We cannot do that on a monitor. It really affects how we think.”

The systems are disruptive due to the paradigm changes, made far worse by their also often being mission hostile in design.

“The problem is each patient is an individual,” said Ms. Burger, who is president of the California Nurses Association. “We need the ability to change that care plan, based on age and sex and other factors.” She acknowledged that the system had one advantage: overcoming the ancient problem of bad handwriting. “It makes it easier for me to read progress notes that physicians have written, and vice versa,” she said.

While this is true, it is also true that the loss of context and structure produces legible gibberish that does not relate the patient narrative well.  Also, the same legibility improvement could be obtained via word processors - or typewriters - that cost far less than the tens of millions of dollars or more per organization that clinical IT commonly costs.

Some experts said they were hopeful that the initial problems with electronic records would be settled over time.

I'm one of them.  Without major health IT industry reforms, however, including strict adherence to evidence-based practices (as that selfsame industry sector demands of medicine and ironically and hypocritically claims its products will enable), I don't expect to see the problems settled in my lifetime.

Dr. Brailer, who now heads Health Evolution Partners, a venture capital firm in San Francisco, said that “most of the clunky first-generation tools” would be replaced in 10 years. “As the industry continues to grind forward, costs will go down,” he said. 

One should ask - why are 'first generation' tools still in abundance, decades into the healthcare information technology industry?  Further, as the industry "grinds forward" without oversight and patient protections, people will be injured.

Mark V. Pauly, professor of health care management at the Wharton School, said the health I.T. industry was moving in the right direction but that it had a long way to go before it would save real money.  “Like so many other things in health care,” Dr. Pauly said, “the amount of accomplishment is well short of the amount of cheerleading.”

That is an understatement.

(Not covered in this article perhaps due to limited space are the issues of information security, privacy and confidentiality that are compromised by current clinical IT.)

In conclusion, it is good that the New York Times has brought the downsides into the public eye.  While the technology's not "ready for prime time", a story like this is ready for prime time, and is in fact long overdue:

-- SS