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Showing posts with label gag clause. Show all posts
Showing posts with label gag clause. Show all posts

As I posted here, my letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" was published in JAMA on July 22, 2009. A preview of the letter can be seen here, or a full version here if you subscribe to JAMA.

This JAMA letter covered some of the same points I addressed extensively at my Drexel HIT website essay "Hold Harmless and Keep Defects Secret Clauses", including the major point that hospital executives signing HIT "Hold Harmless" and "Defects Nondisclosure" contracts are in violation of Joint Commission standards for conduct related to safety, and in violation of their fiduciary responsibilities towards patient and employee safety and freedom from undue liability.

I've sent the following inquiry to Paul M. Schyve, M.D., Senior Vice President, The Joint Commission:

July 24, 2009

Paul M. Schyve, M.D.
Senior Vice President
The Joint Commission
schyve@jointcommission.org

Cc: MChassin@jointcommission.org, otrippi@jointcommission.org

Dear Dr. Schyve,

In testimony to the House Committee on Veterans' Affairs on July 22, 2009 at this link , you state:

... The Joint Commission has established standards that require the hospital to:

  • Create a culture in which adverse events are reported and evaluated for underlying ("root") causes, and preventative actions are taken.
  • Identify high-risk processes and prospectively determine their possible modes of failure, the effects of those failures, and the actions that will prevent the failures or mitigate their effects.
  • Establish a culture of safety throughout the hospital. This accreditation standard became effective January 1, 2009, although its purpose and expectations were publicized for over a year in advance.

In my JAMA letter to the editor of July 22, 2009 entitled " Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" ( link ), I point out that the Hold Harmless and Defects Nondisclosure clauses signed by hospital executives in contracting for healthcare information technology (such as CPOE and EHR systems) are in violation of Joint Commission safety standards, as well as hospital executive fiduciary responsibilities to patients and clinicians. These clinical IT systems can and do cause medical errors and patient harm.

My letter was in response to Koppel and Kreda's March 25, 2009 article " Health Care Information Technology Vendors' "Hold Harmless" Clause: Implications for Patients and Clinicians ", JAMA. 2009;301(12):1276-1278.

I am interested in the Joint Commission's response to the issues I raise.

I await a response.

I recently downloaded the public beta (incomplete trial version) of Apple's new web browser Safari 4.

I like its user experience and features, presenting a main page "posterboard" of most visited or user-selected sites, a searchable, flip-panel history of visited pages (using the Macintosh OS X Spotlight and Cover Flow paradigms), top located tabs, and other useful features. (Note: I use both Macs and PC's, and hold no financial stakes in Apple whatsoever.)

What struck me was the vociferous online discussions and debates about every facet of the new browser version, down to the level of minutiae. The following review particularly struck me for its level of detail - Observations, Complaints, Quibbles, and Suggestions Regarding the Safari 4 Public Beta Released One Week Ago, Roughly in Order of Importance by John Gruber. It includes minutiae such as this:

... THE TABS

Safari’s new tab layout, placing the tabs directly in the window title bar, is a radical change. There’s no use addressing the specific details — good and bad — of this new arrangement, without first trying to figure out why Apple did this. Again, the designers are behind Apple’s wall of silence, so we’re left to speculate.

Rule out the notion that Safari’s designers undertook this change lightly. This is a major change to an important feature that many users feel strongly about. My guess is that this is an attempt to bring tabbed browsing to the masses. The biggest and most important change is that the interface for the tabs is now far more prominent. In fact, previously, the entire interface for tabbed browsing was not visible in Safari by default — in a window with just one tab, Safari’s default settings were such that the tab bar was not shown.

In Safari 4, there’s a prominent and unique “+” button that is always visible in the top right corner of every window, where the standard tic-tac button for toggling the display of the toolbar usually resides.1 Because the interface to create new tabs is now obvious, I can only assume that the point of this redesign is to encourage more people to use, or at least try, tabbed browsing.

But the problems with this new tab layout are significant.

Conceptually, the basic idea is sound. Browser tabs are, effectively, a collection of separate browser windows grouped together in a single parent window. Safari’s new tab layout makes this a tab is like a sub-window metaphor more explicit. The anchor, the conceptual root, of a standard Mac OS window is the title bar, and in Safari 4, the tabs aren’t just in the title bar, they are the title bar ...

Etcetera and so forth, on and on, as in other reviews easily found online.

In Electronic Health Records and other clinical IT, by way of contrast, reviews at this level of detail are ... nearly nonexistent (I use the term "nearly" because I authored such a review, in general terms, starting here). One reason EHR and other clinical IT user experience and performance debates are so rare is because customers are contractually forbidden to engage in them publicly. Koppel's and Kreda's JAMA paper makes that clear:

Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278

Vendors claim they are protecting their "intellectual property." I'm not exactly sure what IP they are holding as closely as the crown jewels.

Is it their:

  • Earth shaking, 22nd century user interfaces?
  • Secretive and ingenious widgets that revolutionize user selection from choice lists?
  • Hyper-efficient, never before seen data structures and algorithms?
  • Artificial intelligence routines that would make Captain Picard and his android sidekick Mr. Data envious?

In other words, what, exactly, is being protected by shielding commercial EHR's from external scrutiny and debate?


Is this the Secret Sauce the commercial EHR vendors seek to conceal?

The loss engendered by such policies is the reduced feedback from, and reduced interaction among endusers. This interaction occurs commonly on the Internet in 2009 on a great number of topics, but EHR user experiences are not one of them.

Companies like Apple and Microsoft, strongly user centric, encourage such debates through release of their beta's, both of enduser tools and of operating systems e.g., Windows 7 Beta. I should note that with these pieces of software, lives are not at stake, unlike with electronic health records systems.

The Veterans Health Administration makes a full working copy of VistA Computerized Patient Record System (CPRS) available as a free public download to anyone in the world here. I use it in my teaching (and am forced to do so, as commercial EHR demos are as available as, say, demos of the National Security Agency's spy and decryption software).

What, exactly, is the commercial EHR vendors' real excuse for the levels of product secrecy they maintain?

Could it be embarrassment and fear of exposure of defects, ill conceived design features and a mission hostile user experience?

In this post I make a very shameful comparison. Shameful to the healthcare industry, that is, and coming from an unusual perspective due to my diverse professional background.

I received quite interesting comments from a number of informatics colleagues regarding the linked patient's account of Health IT mayhem at "A Most Interesting Patient Account of Misery by EHR". The comments suggested that patient's account was not unusual.

Example:

Without being specific I can say from first hand information that this is not an isolated incident... the horrific experience is unfortunately in my direct experience typical.

and this:

... As you know, I’ve been in the HIT business, advocating for full integration of computing into clinical care, for more than three decades. The upshot, though, is that this country’s hospitals are not ready for wholesale automation of even the most rudimentary kind (such as using barcodes in clinical settings), much less a real EMR. I’d give it another 10-15 years ... before even considering advocacy for much in the way of EMRs. Not that there are EMRs we should advocate for now, in any case.

and this:

This hits home, I hope this gentleman keeps telling his story. He is one of the lucky ones that "lived to tell". These are the stories no one believes until it happens to them or a loved one ... He would be saving lives if he talks. I know the retaliation is hard to swallow. I lost my job, but walked out with dignity because I know that I did the right thing. This was such a traumatic event for him and he was one of the lucky ones who were coherent enough to know that something was wrong.

My colleagues are afraid of giving specifics largely due to fear of reprisal from their healthcare and health IT employers. Health IT chaos, though, is clearly more widespread than commonly reported.

Yet in the U.S. in 2009 we find ourselves poised to rapidly spend $20 billion, more than the annual budget of NASA (at $18.7 billion), on these unproven technologies.

Now, a little history from my heterogeneous past:

After a 1990 subway accident in Philadelphia that killed several people and injured hundreds, at a time when I was Medical Programs Manager [of preventive programs] and Medical Review Officer for the regional transit authority SEPTA (pre-informatics), I became sensitized to the potential outcomes of complacency. As I wrote here, some of the the factors contributing to the accident involved complacency and the ignoring of medical advice by non medical personnel.

Yet, the National Transportation Safety Board (NTSB) came in and investigated thoroughly. Improvements were made.

Has something similar ever occurred after an HIT failure?

It always puzzled me why my concerns about health IT problems, dating from my time as a hospital-based Chief Medical Informatics Officer (CMIO) in the 1990's, seemed to raise little concern among the IT and hospital administration and even among some of the hospital physicians themselves. It still puzzles me why my colleagues in active CMIO roles report the same problems in 2009.

It concerns me greatly that HIT is entirely unregulated as its devices become far more complex, and more intrusive in the "biochemical pathways-like" organizational complexities of healthcare. It concerns me that HIT vendors have the best environment of any healthcare vendor: freedom from liability and accountability, and freedom from defect disclosure. It concerns me that hospital executives have agreed to such terms, I believe violating both their Joint Commission safety standards obligations and their fiduciary responsibilities.

As a hospital CMIO observing profound HIT difficulties, it was as if I was supposed to simply acquiesce to the chaos in a medical ICU, in a cardiac catheterization lab, medical clinics, etc. caused by HIT design and implementation deficiencies. It was as if the reaction to my detailed accounts of issues putting patients at risk was that I was simply not a 'team player.' The complacency was palpable. The behaviors consistent with a belief that the IT personnel were wizards, exempt from the scrutiny afforded to mere mortals, was equally palpable.

It was jarring and bizarre. In fact, being a CMIO was more jarring than my earlier physician role in the Philadelphia transit authority, where I sometimes had to deal with very troubled vehicle operators with substance abuse problems and aggressive, sometimes abusive and very scary Philly union officials.

As an example of what I dealt with in that environment, I scanned a 1988 SEPTA transport workers union newsletter whose cover shows a drawing of an injured employee on crutches and a Donald Duck figure with a stethoscope representing the Medical Department physicians, holding a note telling the ostensibly crippled employee to return to work. The newsletter cover is at this link (jpg) and below.


(click to enlarge)


Note the text about the medical department and the duck cartoon on the right depicting the doctors ("quack, quack").

In retrospect, I felt far less uncomfortable as a physician in the mass transit environment than I did as a CMIO at a major hospital. I did not expect much in the way of rigor and science from a transit agency and transit union leaders.

Remarkably, though, I also never feared retaliation or being fired for pointing out potential safety problems. Doing so, in fact, was taken quite seriously, by the Medical Director, the GM's office, Industrial Relations, the system Safety Officer, even the unions when presented the cold, hard facts. Never as Medical Programs Manager and Medical Review Officer was I ignored, as I was as a hospital CMIO.

I felt less comfortable as a hospital CMIO than in the mass transit authority, as I expected a lot more from hospital leadership ... and still do.

On the other hand, I respected the union leaders' directness and unabashed defense of their membership.

Physicians can learn something from them in regards to defense of patient care, and defense of their own profession.

My writing style has, in part, certainly been informed by past interactions with TWU, UTU, BLET, BRS and other transit union leaders and members.

-- SS

Addendum Apr. 18:

Although the causality of this terrible accident just one day after my post above is yet to be determined, I am often reminded of the public safety aspects of my prior line of work in ensuring fitness for duty of public servants in safety sensitive roles:

Sat, Apr. 18, 2009
Man struck, killed by SEPTA bus

By DAVID GAMBACORTA
Philadelphia Daily News

Milton Boneta cheated death seven months ago when he was struck by a SEPTA bus in his wheelchair at 8th Street and Girard Avenue. Fate revisited him in cruel fashion at the same intersection yesterday. This time, he was not as lucky.

Police said the Route 47 bus crushed Boneta, 61, as he crossed 8th Street in his motorized wheelchair at about 4:15 p.m. Based on the reactions of witnesses and the grisly scene, there was no chance he could have survived this accident ...

"The operator told me to check for a pulse or to see if he was breathing," [a witness] said, adding that his body clearly was too badly mangled for any lifesaving efforts.

Remembering what I used to do in public transit vs. the inability to perform a similar function as a CMIO in hospitals brings into focus the absurdity of allowing IT personnel to have a veto on issues that concern patient care and safety. (As the head of the Division of Biostatistics and Bioinformatics of a major medical center who had his staff review my HIT site recently wrote me, he "could not imagine any reasonable individual" - i.e., hospital executive - allowing that situation to occur, and found it "downright scary.")

Hospitals can cover up and bury their mistakes, especially when related to the relatively esoteric issues of HIT dysfunction, so perhaps their attitudes can be more cavalier than in the transit industry.