Grand Jury: Ventura County, Calif., Mishandled Electronic Health Records Transition

In Ventura County, California, "the function of the Grand Jury is to act as a civil oversight of county and city government, special districts, governing boards, personnel commissions, school districts, and humane officers. It is their responsibility to insure that government is serving the best interests of Ventura County's citizens" (<a href="http://www.ventura.org/grand-jury">http://www.ventura.org/grand-jury</a>).<br /><br />Even under such a grand jury, the need for true Health IT experts (instead of amateurs) seems to have gone unnoticed.<br /><br />A 2013-2014 Ventura County Grand Jury conducted an investigation in response to information received regarding the implementation of a new Electronic Health Records system by the Ventura County Health Care Agency (VCHCA).<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjVcN68BX3lrwSkNpyg43gOlh2ZVsoEEIOjbxs5z7zfCB1lCwU4wNFXT8RqxVKLzB2fEcZrfszNMExQIeTB9tF1RNAFGAmoObnBIX4D0ZyBaFVRgSV53p-XdqoaG0iNhrumlvUV14Dwx9dr/s1600/grandjury.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjVcN68BX3lrwSkNpyg43gOlh2ZVsoEEIOjbxs5z7zfCB1lCwU4wNFXT8RqxVKLzB2fEcZrfszNMExQIeTB9tF1RNAFGAmoObnBIX4D0ZyBaFVRgSV53p-XdqoaG0iNhrumlvUV14Dwx9dr/s1600/grandjury.jpg" width="246" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Ventura County Grand Jury Final Report "<b>Healthcare Records Processes and Procedures</b>" (full PDF at <a href="http://vcportal.ventura.org/GDJ/docs/reports/2013-14/Healthcare_Records-05.29.14.pdf">http://vcportal.ventura.org/GDJ/docs/reports/2013-14/Healthcare_Records-05.29.14.pdf</a>)</td></tr></tbody></table><br /><br />From the May 29, 2014 Ventura County Grand Jury Final Report "<b>Healthcare Records Processes and Procedures</b>" (full PDF at <a href="http://vcportal.ventura.org/GDJ/docs/reports/2013-14/Healthcare_Records-05.29.14.pdf">http://vcportal.ventura.org/GDJ/docs/reports/2013-14/Healthcare_Records-05.29.14.pdf</a>).  Read the full report.  Any reader of this blog or my Drexel HIT site at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a> will recognize very familiar patterns.<br /><br />Here are some highlights:<br /><br /><blockquote class="tr_bq">In April 2012, VCHCA hired an independent Information Technology (IT) consultant to oversee the EHR implementation; however, he was not authorized to be project manager.</blockquote><br />An "independent IT consultant" who had no formal Medical Informatics expertise is a likely explanation for all that followed.  (Even if he did, his relegation to "internal consultant" was an attempt to seduce failure into rearing her ugly head.)<br /><br /><blockquote class="tr_bq">The Grand Jury found that, beginning with the authorization of the Cerner contract in October 2011, there was a lack of a dedicated and experienced project manager to oversee, track, and report all tasks related to the EHR implementation. T<b>he absence of a recognized standard project plan</b>, as shown in the Project Management Institute’s A Guide to the Project Management Body of Knowledge (PMBOK® Guide), contributed to staff being inadequately prepared for using the new system and to a problematic EHR system implementation by VCHCA.</blockquote><br />Lack of a "recognized standard project plan" was likely the least of the problems. <br /><br /><blockquote class="tr_bq">The Grand Jury found hiring of “contract staff” did not support project needs. The Ventura County Board of Supervisors’ (BOS) approval of additional funds allowed for the hiring of deployment staff. Hiring did not commence until August 2012, and continued after the VCHCA system “go-live” date of July 1, 2013. This indicated a lack of planning and diligence in pursuing the necessary qualified staff.</blockquote><br />Lack of enough "contract IT staff" was likely the least of the problems. <br /><br /><blockquote class="tr_bq">The Grand Jury found that staff training on the new equipment was insufficient, leading to a lack of experience and knowledge with all components of the EHR system. There was a period of inefficient and delayed patient care. <br /><br />Billing processes were significantly impacted, requiring manual intervention, taking additional time.</blockquote><br />These are symptoms of what was likely truly lacking.<br /><br /><blockquote class="tr_bq">The Grand Jury found that VCHCA ordered the user hardware in May and June 2013, too late to allow proper time for configuring of computers, hardware testing, and user familiarization.<br />  <br />The Grand Jury found that VCHCA had until the end of December 2014 to implement the new EHR system to avoid federal penalties.<br /><br />The Grand Jury found that VCHCA had to be on the EHR system for 90 days prior to September 30, 2013, to qualify for full Meaningful Use funding, therefore July 1, 2013 was selected as its go-live date.</blockquote><br />It was all about money.  Still, that was not the likely problem.<br /><br />The problem was likely <b>leadership by healthcare IT amateurs</b>**, lacking formal cross-disciplinary expertise in medicine and clinical computing.<br /><br />Without that expertise, empowered in <b>top leadership roles</b>, these projects will fail or will be seriously impaired, at great cost.<br /><br />If you don't believe me, believe the NIH (<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html</a>).<br /><br />While the 'Grand Jury' investigation of a failed health IT project may be a first, and is not a bad development in my mind, perhaps the members of the Grand Jury need to read a bit more. <br /><br />-- SS <br /><span style="font-size: x-small;"><br /></span><span style="font-size: x-small;">** I am a <b>radio amateur</b>, a formal FCC designation for those licensed to use radio and who have some knowledge, but who are not formal radio telecommunications engineers (unless they have the required formal education, training and experience, of course).</span><br /><br />

Grand Jury: Ventura County, Calif., Mishandled Electronic Health Records Transition

In Ventura County, California, "the function of the Grand Jury is to act as a civil oversight of county and city government, special d...

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Athens Regional Medical Center: Hospital management is "addressing computer problems" AFTER patients are put at bodily risk, not before, only in response to irate clinicians; then claiming everything will be fixed soon while doctors resign.

<div style="text-align: center;"><span style="font-size: x-small;">(Note: also see my June 16, 2014 followup post at <a href="http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html">http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html</a>)</span> </div><br />Maybe hospital management gurus could address these computer problems BEFORE turning them loose on patients?<br /><br />Physicians in Georgia seem to have more guts than their colleagues elsewhere.  Rather than letting patients be guinea pigs for the naive fantasies of hospital executives about health IT, these physicians said "get these [expletive] computer systems out of our hospital"...<br /><br />Then they started <i>resigning their appointments: </i><br /><br /><blockquote class="tr_bq"><b>Athens Regional addressing new computer system problems encountered by doctors</b><br /><br />By Donnie Z. Fetter<br />Friday, May 23, 2014<br /><br /><a href="http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors">http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors</a><br /><br />Doctors affiliated with Athens Regional Medical Center (<a href="http://www.athenshealth.org/">http://www.athenshealth.org/</a>) have expressed concerns that<b> a computer system installed this month at the hospital endangers patients.</b></blockquote><br />Not "may endanger patients."  "Endangers patients."  That's quite direct. <br /><br /><blockquote class="tr_bq">However, the hospital's chief executive said Athens Regional is taking "swift action" to address those concerns.</blockquote><br />I'm not impressed.  The executives should perhaps have done due diligence and taken action <b>BEFORE this bad health IT was set loose on live, unsuspecting patients</b>.<br /><br />It's not as if the issues are unknown (as Google or anyone who actually knows what they're doing regarding health IT will easily demonstrate).  Further, those executives have the legal obligation to maintain a safe healthcare environment.<br /><br /><blockquote class="tr_bq">In a letter dated May 15 and provided to the Athens Banner-Herald this week, multiple doctors noted such concerns as<b> “medication errors ... orders being lost or overlooked ... (emergency department) patients leaving after long waits; and of an inpatient who wasn’t seen by a physician for (five) days.”</b></blockquote><br />Any of these issues and the multitude more I can predict exist can lead to severe injury or death, especially in fragile patients and the elderly.  Trust me, I know both professionally and personally... <br />  <br /><blockquote class="tr_bq">The letter was addressed to ARMC President and CEO James G. Thaw and <b>Senior Vice President and CIO Gretchen Tegethoff.</b> It was signed by more than a dozen physicians, including Carolann Eisenhart, president of the medical staff; Joseph T. Johnson, vice president of the medical staff; David M. Sailers, surgery department chair; and, Robert D. Sinyard, medicine department chair.<br /><br />The doctor who provided the letter to the Banner-Herald<b> refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues.</b></blockquote><br /><b>Refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues ... </b>due to fear the executives would then return the doctor's concerns with genuine love and appreciation, and give him or her a generous promotion and pat on the back, no doubt.  (Actually, quite likely was a fear of retaliation, e.g. sham peer review as at <a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians">http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians</a>.)<br /><br />Note the educational background of CIO Gretchen Tegerhoff, the executive with fiduciary obligations to implement health IT of the highest quality and to have robustly researched all of the issues involved (and whom the Board should have thoroughly vetted as to required background for health IT leadership):<br /><br /><blockquote class="tr_bq">University of Georgia<br />Terry College of Business, Executive Program, Finance<br />2014 – 2014 (expected)<br /><br />The George Washington University - School of Business<br />Master of Science, Information Systems Technology<br />2001 – 2003<br /><br />West Virginia University<br />BS, Medical Technology<br />1993 – 1997 </blockquote><br />Note the career progression that is the envy of, say, someone who's completed the rigors of medical training (premed, medical school, internship/residency, clinical postdocs) and beyond that, completed an additional PhD, MS or post-doctoral fellowship in Medical Informatics at unknown universities such as Harvard, Yale, Stanford, Johns Hopkins, Columbia, etc. (reverse chrono):<br /><br /><blockquote class="tr_bq">Technical Analyst<br />STG (9 months)<br />[Provided U.S. Department of State with systems support and application maintenance.]<br /><br />Clinical Systems Analyst<br />George Washington University Hospital (3 years 8 months)<br /><br />Technical Support Specialist/Installer<br />Intellidata, Inc. (9 months)<br /><br />Clinical Research Associate<br />QUINTILES, INC. (9 months)<br /><br />Information Specialist<br />THE EMMES CORPORATION (1 year 8 months)<br /><br />Writer/Editor<br />ASPEN SYSTEMS CORPORATION (7 months)<br /><br />Medical Technologist<br />PROVIDENCE LABORATORY ASSOCIATES (8 months) </blockquote><br />This background led directly to:<br /><br /><blockquote class="tr_bq">Chief Information Officer<br />George Washington University Hospital (6 years 8 months) </blockquote><br />and then the current role:<br /><br /><blockquote class="tr_bq">Athens Regional Health System<br />Vice President and Chief Information Officer<br />Athens Regional Health System</blockquote><br />If you believed that the qualifications required for medical practice - let alone medical leadership roles - is at least an order of magnitude more robust, you'd not be mistaken.<br /><br />Perhaps even worse, business-IT amateur meddlers in clinical affairs sell the "best practices" that lead to debacles like this, and perhaps to IT-related patient injury and death, via their alphabet-soup "leadership" organizations.  This CIO also holds this credential:<br /><br /><blockquote class="tr_bq"><style type="text/css">H3 { margin-bottom: 0.08in; }H3.cjk { font-family: "Droid Sans Fallback"; }H3.ctl { font-family: "Lohit Hindi"; }P { margin-bottom: 0.08in; }</style> <br /><div class="western">Faculty</div><div class="western">CHIME Healthcare CIO Boot Camp (8 months) </div></blockquote><br />It should be noted, and scandalously so considering the negligence that leads to patient endangerment and this kind of physician revolt from the outset, that IT-related patient harms are not uncommon.  For example, per the Harvard community's med mal insurer CRICO, see "<b>Malpractice Claims Analysis Confirms Risks in EHRs</b>" at<br /><a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>, the ECRI Institute, see "<b>ECRI Deep Dive Study of Health IT harms</b>" at <br /><a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a> as well as "<b>ECRI Institute's 2014 Top 10 Patient Safety Concerns for Healthcare Organizations</b>" at <br /><a href="http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html">http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html</a>, "<b>FDA Internal Memo on H-IT risks - for internal use only</b>" (uncovered by investigative reporter Fred Schulte) at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>, and others as posted at this blog.<br /><br /><blockquote class="tr_bq">“From the moment our physician leadership expressed concern about the Cerner I.T. conversion process on May 15, <b>we took swift action and significant progress has been made toward resolving the issues raised</b>,” Thaw wrote Thursday in an email. “Providing outstanding patient care is first and foremost in our minds at Athens Regional, and we have dedicated staff throughout the hospital to make sure the system is functioning as smoothly as possible through this transition."</blockquote><br />This raises several questions: <br /><br /><ul><li>How about the moments <i><b>from the time of decision to acquire the technology?  What safety consideration were in effect during that time?</b></i><i><b> </b></i></li></ul><i><b></b></i><br /><ul><li><i><b>What if the "significant progress" is insufficient to prevent a patient from being maimed or killed due to toxic effects of bad health IT?  Who's responsible?</b></i><i><b> </b></i></li></ul><i><b></b></i><br /><ul><li><i><b>Perhaps most importantly from the human rights perspective - are patients being provided informed consent about these "issues raised" and are they afforded the opportunity to seek care elsewhere until the "swift progress" is completed? </b></i> </li></ul><br />One wonders if the executives were aware of analytic work on Cerner ED systems such as performed by U. Sydney professor Jon Patrick at <b>"A study of an Enterprise Health information System", </b> <span class="Apple-style-span" style="font-size: x-small;"></span><a href="http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146">http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146</a>; or this site on health IT difficulties:  <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>, or this blog and others.<br /><br />It's not as if a simple Google search won't find them, such as <a href="https://www.google.com/search?q=healthcare+IT+failure">https://www.google.com/search?q=healthcare+IT+failure</a>.  Perhaps they need to read more...or hire experts BEFORE go-live.<br /><br />Back to the article:<br /><br /><blockquote class="tr_bq">The intended goal of the system designed by health care information technology company Cerner is to improve efficiency and connectivity by providing doctors, nurses and other medical professionals with a shared data set and to eventually allow patients online access to their medical records, Athens Regional executives previously said.</blockquote><br />Good intentions or not, badly designed and/or implemented technology harms or kills, and those harmed, or the dead, really don't care what the system is 'intended to do.'  Patients are not guinea pigs towards an IT company's or hospital's experiments with computers - regarding which the executives are usually in to at a level way over their collective heads.<br /><br /><blockquote class="tr_bq">But doctors noted the new system<b> often proved too cumbersome to be effective at the time the letter was written.</b><br /><br />“The Cerner implementation <b>has driven some physicians to drop their active staff privileges at ARMC,</b>” noted the letter. “<b>This has placed an additional burden on the hospitalists, who are already overwhelmed.</b> </blockquote><br />That's just <i>horrendous</i> for safety.<br /><br /><b>Joint Commission, where are you?</b><br /><b> </b> <br /><blockquote class="tr_bq">Other physicians are directing their patients to St. Mary’s (hospital) for outpatient studies, (emergency room) care, admissions and surgical procedures. ... Efforts to rebuild the relationships with patients and physicians (needs) to begin immediately.”</blockquote><br />Doctors voted with their feet.  Bravo.<br /><br />I suggest they consider the following remedies as well if appropriate, from my post at <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html</a>:<br /><br /><blockquote class="tr_bq">... When a physician or other clinician observes health IT problems, defects, malfunctions, <a href="http://www.tinyurl.com/hostileuserexper">mission hostility</a> (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):<br /><br />(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.) <br /><br /><br /><ul><li>Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "<a href="http://www.jpands.org/vol9no3/huntoon.pdf">disruptive physician</a>" and/or or being subjected to sham peer review (<a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">link</a>).</li></ul><ul><li>Inform their personal and organizational <span style="font-weight: bold;">insurance carriers</span>, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal"> at this link</a>. (Note - many medical malpractice insurance policies can be interpreted as <span style="font-style: italic; font-weight: bold;">requiring</span><span style="font-weight: bold;"> </span>this reporting, observed occasional guest blogger <a href="http://hcrenewal.blogspot.com/search/label/Dr.%20Scott%20Monteith">Dr. Scott Monteith</a> in a comment to me about this post.)</li></ul><ul><li>Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at <a href="http://www.jointcommission.org/report_a_complaint.aspx">http://www.jointcommission.org/report_a_complaint.aspx</a> . Also consider writing the JC senior officers (<a href="http://www.jointcommission.org/about_us/joint_commission_officers.aspx">link to officer's list</a>), whose awareness of HIT issues I can personally attest to via our correspondences.</li></ul><ul><li>Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at <a href="https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm">https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm</a>. An example of such an adverse event report I filed myself (when the involved hospital refused) is <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1729552">at this link</a> in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.</li></ul><ul><li>Inform the State Medical Society and local Medical Society of your locale.</li></ul><ul><li>Inform the appropriate Board of Health for your locale.</li></ul><ul><li>If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "<a href="http://www.qipa.org/Home.aspx">Quality Insights of PA</a>."</li></ul><ul><li>Inform a personal attorney.</li></ul><ul><li>Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.</li></ul><ul><li>As clinicians are often forced to use health IT, at their own risk even when "certified" (<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">link</a>), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:</li></ul><blockquote><span style="font-style: italic;">"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]</span><br /><br style="font-style: italic;" /><span style="font-style: italic;">We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients.</span> <span style="font-style: italic;">We assume responsibility for any such malpractice.</span><br /><br style="font-style: italic;" /><span style="font-style: italic;">With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at </span><a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF" style="font-style: italic;">http://www.jointcommission.org/assets/1/18/SEA_42.PDF</a><span style="font-style: italic;">, the IOM report on HIT safety at </span><a href="http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF" style="font-style: italic;">http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF</a><span style="font-style: italic;">, and the FDA Internal Memorandum on H-IT Safety Issues at </span><a href="http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology" style="font-style: italic;">http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology</a><span style="font-style: italic;">.</span><br /><br style="font-style: italic;" /><span style="font-style: italic;">CMO __________ (date, time)</span><br /><span style="font-style: italic;">CIO ___________ (date, time)</span><br /><span style="font-style: italic;">CMIO _________ (date, time)</span><br /><span style="font-style: italic;">General Counsel ___________ (date, time)</span><br /><span style="font-style: italic;">etc."</span></blockquote><ul><li>If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.</li></ul><ul><li>As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.</li></ul><br style="font-weight: bold;" />These measures can help "light a fire" under the decision makers, and "get the lead out" of efforts to improve this technology to the point where it is usable, efficacious and safe.</blockquote><br />More from the article:<br /><br /><blockquote class="tr_bq">Doctors called the time line to install the EHR system too “aggressive” and said there was a “lack of readiness” among the intended users.</blockquote><br />For financial incentive reasons in part, I'm sure.  Computers, after all, seem to have more rights than patients...or than physicians and nurses.<br /><br /><blockquote class="tr_bq">Since receiving the letter, Thaw said Athens Regional has added "specialized staff" to meet daily with physicians to discuss computer system and safety issues.</blockquote><br />Again, the key word is "AFTER."   A good move, considering the hospital will be up to its head in defections, accreditation inspections and hearings, and possible medical malpractice and corporate liability lawsuits otherwise.<br /><br /><blockquote class="tr_bq">"Regardless of what system we are using, <b>our focus on patient safety is unwavering</b>, and we will never put a system ahead of doing what is right for our patients," Thaw said. "Our team is working around the clock to resolve any remaining issues, and we remain dedicated to delivering outstanding patient care every step of the way."</blockquote><br />Feel-good executive boilerplate and an outright lie on its face.  If the focus on safety was unwavering, this problems would not now need emergency remediation.  As I had written many years ago here: <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story</a>, this type of shallow executive puffery and rhetoric only makes clinicians angrier.<br /><br />And while events like this go on, the industry pundits suggest all that's needed is a Health IT 'Safety Center' instead of regulation like the rest of the healthcare industry (<b>"Feds Call For Health IT Safety Center"</b>, May 20, 2014,<a href="http://www.govhealthit.com/news/feds-call-hit-safety-center?topic=,26#.U4FVDnYsC"> http://www.govhealthit.com/news/feds-call-hit-safety-center?topic=,26#.U4FVDnYsC</a>).  This is sort of like putting the safety of our country's hospitals in the hands of Consumer Reports.<br /><br />That's not exactly the ticket to a rapid cure to these problems, which are more common than most physicians have the bravery (or career options in the face of retaliation) to admit.<br /><br />At least nurses' unions are taking action, as at<a href="http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html"> http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html</a> and <a href="http://hcrenewal.blogspot.com/2014/05/a-nurses-union-national-nurses-united.html">http://hcrenewal.blogspot.com/2014/05/a-nurses-union-national-nurses-united.html</a>.<br /><br />Additional thought:  at least the writer of the article did not use the customary euphemism for problems with patient-endangering bad health IT, specifically: "glitches" (<a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>). <br /><br />-- SS<br /><br /><b>May 27, 2014 Addendum</b>:<br /><br />The CEO has apparently resigned, see <a href="http://onlineathens.com/local-news/2014-05-23/thaw-resigns-athens-regional-ceo">http://onlineathens.com/local-news/2014-05-23/thaw-resigns-athens-regional-ceo</a>.  <br /><br />I also solicit physicians from the area of this hospital to contact me regarding any patient harms that did occur as a result of this debacle, via my email address located here: <a href="https://www.blogger.com/profile/03994321680366572701">https://www.blogger.com/profile/03994321680366572701</a>.  I will forward any reports through appropriate legal channels to attorneys who can take action, which in 2014 is probably the only language this industry will actually listen to.<br /><br />-- SS<br /><br /><b>May 27, 2014 Addendum 2:</b><br /><br />The reader comments at <a href="http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors">http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors</a> are interesting, and distressing.<br /><br />-- SS<br /><br /><b>May 29, 2014 Addendum:</b><br /><br />More here:  <a href="http://flagpole.com/news/in-the-loop/james-thaw-out-as-armc-ceo">http://flagpole.com/news/in-the-loop/james-thaw-out-as-armc-ceo</a><b> </b><br /><br />If I were that's hospital's new leadership, I'd immediately go back to whatever system (whether paper or not) was in place before this implementation, and <b>take the time to implement new health IT properly, safely and carefully.</b><br /><br />For at this point, if patient injury or death occurs as a result of a system flaw (whether in design or implementation), I believe charges of criminal negligence against the organization and its leaders would be justified.<br /><br />The following is an example of one state's statute defining criminal negligence:<br /><br /><blockquote>''A person acts with 'criminal negligence' with respect to a result or to a circumstance described by a statute defining an offense when he fails to perceive a substantial and unjustifiable risk that such result will occur or that such circumstance exists. The risk must be of such nature and degree <b>that the failure to perceive it constitutes a gross deviation from the standard of care that a reasonable person would observe in the situation.</b>''</blockquote><br />I believe other states' statutes are similar.<br /><br />-- SS<br /><br /><b>June 13, 2013 Addendum:</b><br /><br />My post on Athens Regional Medical Center's physician revolt was accessed today by someone at Cerner; note the referring link:  <a href="http://cerner.vertabase.com/project/document/index.cfm?&0.12455576848">http://cerner.vertabase.com/project/document/index.cfm?&0.12455576848</a><br /><br />Vertabase (<a href="http://www.vertabase.com/">http://www.vertabase.com/</a>) makes project management software.<br /><br />Cerner.vertabase.com/project/document is some sort of password-protected document resource.<br /><br />I find that interesting - perhaps it's for internal communications and they are learning something from me. <br /><span style="font-family: inherit;"></span><b><br /><br /><span class="HOEnZb"></span></b><br /><table border="0" cellpadding="1" cellspacing="1" style="width: 450px;"><tbody><tr bgcolor="#F5F5E2"><td align="right" width="150"><span style="font-family: Arial;">Domain Name</span></td><td align="center" width="10"></td><td width="290"><span style="font-family: Arial;"> (Unknown) </span></td></tr><tr><td align="right" valign="top"><b><span style="font-family: Arial;">IP Address</span></b></td><td align="center"></td><td><b><span style="font-family: Arial;">159.140.254.# (Cerner Corporation)</span></b></td></tr><tr bgcolor="#F5F5E2"><td align="right"><span style="font-family: Arial;">ISP</span></td><td align="center"></td><td><span style="font-family: Arial;">Cerner Corporation</span></td></tr><tr><td align="right" valign="top"><span style="font-family: Arial;">Location</span></td><td align="center"></td><td><table cellpadding="0" cellspacing="0"><tbody><tr><td><span style="font-family: Arial;">Continent</span></td><td> : </td><td><span style="font-family: Arial;">North America</span></td></tr><tr><td valign="top"><span style="font-family: Arial;">Country</span></td><td valign="top"> : </td><td><span style="font-family: Arial;"><a href="http://www.sitemeter.com/?a=stats&s=s20hcrenewal&v=100&country=US&vlr=14&pg=21&r=76" target="_blank">United States</a> <a href="http://www.sitemeter.com/?a=stats&s=s20hcrenewal&v=100&country=US&vlr=14&pg=21&r=77" target="_blank"><img border="0" height="12" src="https://blogger.googleusercontent.com/img/proxy/AVvXsEjqRg30-NBYCTvdB5xbLIeWb8pInOkPdRZk2QQR2-V1aYwwwkKPVx8XWaG3Pc8GRDYGnkcPfOIZBAzBPLDYY7EhDVN0UO6vMyU8u-Zqgv165Xdliu3lU51bGzEAUayvD-YcR61pttguytcd5RQ=s0-d-e1-ft" width="18" /></a> <a href="http://www.sitemeter.com/?a=stats&s=s20hcrenewal&v=100&country=US&vlr=14&pg=21&r=78" target="_blank">(Facts)</a></span></td></tr><tr><td><span style="font-family: Arial;">State</span></td><td> : </td><td><span style="font-family: Arial;">Kansas</span></td></tr><tr><td><span style="font-family: Arial;">City</span></td><td> : </td><td><span style="font-family: Arial;">Kansas City</span></td></tr><tr><td><span style="font-family: Arial;">Lat/Long</span></td><td> : </td><td><span style="font-family: Arial;">39.1111, -94.6904 <a href="http://www.sitemeter.com/?a=stats&s=s20hcrenewal&r=75&pg=21&vlr=14&v=100" target="_blank">(Map)</a></span></td></tr></tbody></table></td></tr><tr bgcolor="#F5F5E2"><td align="right" valign="top"><span style="font-family: Arial;">Language</span></td><td align="center"></td><td><span style="font-family: Arial;">English (U.S.)<br /><small>en-us</small></span></td></tr><tr><td align="right"><span style="font-family: Arial;">Operating System</span></td><td align="center"></td><td><span style="font-family: Arial;">Macintosh MacOSX</span></td></tr><tr bgcolor="#F5F5E2"><td align="right" valign="top"><span style="font-family: Arial;">Browser</span></td><td align="center"></td><td><span style="font-family: Arial;">Safari 1.3<br /><small>Mozilla/5.0 (Macintosh; Intel Mac OS X 10_8_5) AppleWebKit/536.30.1 (KHTML, like Gecko) Version/6.0.5 Safari/536.30.1</small></span></td></tr><tr><td align="right" valign="top"><span style="font-family: Arial;">Javascript</span></td><td align="center"></td><td><span style="font-family: Arial;">version 1.5</span></td></tr><tr bgcolor="#F5F5E2"><td align="right" valign="top"><span style="font-family: Arial;">Monitor</span></td><td align="center"></td><td><span style="font-family: Arial;"><table cellpadding="0" cellspacing="0"><tbody><tr><td><span style="font-family: Arial;">Resolution</span></td><td><span style="font-family: Arial;"> : </span></td><td><span style="font-family: Arial;">1440 x 900</span></td></tr><tr><td><span style="font-family: Arial;">Color Depth</span></td><td><span style="font-family: Arial;"> : </span></td><td><span style="font-family: Arial;">24 bits </span></td></tr></tbody></table></span></td></tr><tr><td align="right"><span style="font-family: Arial;">Time of Visit</span></td><td align="center"></td><td><span style="font-family: Arial;"><span title="Jun 13 2014 11:47:42">Jun 13 2014 11:47:42 am</span></span></td></tr><tr bgcolor="#F5F5E2"><td align="right"><span style="font-family: Arial;">Last Page View</span></td><td align="center"></td><td><span style="font-family: Arial;"><span title="Jun 13 2014 11:47:42">Jun 13 2014 11:47:42 am</span></span></td></tr><tr><td align="right"><span style="font-family: Arial;">Visit Length</span></td><td align="center"></td><td><span style="font-family: Arial;">0 seconds</span></td></tr><tr bgcolor="#F5F5E2"><td align="right"><span style="font-family: Arial;">Page Views</span></td><td align="center"></td><td><span style="font-family: Arial;">1</span></td></tr><tr><td align="right" valign="top"><b><span style="font-family: Arial;">Referring URL</span></b></td><td align="center"><b><br /></b></td><td><b><span style="font-family: Arial;"><a href="http://cerner.vertabase.com/project/document/index.cfm?&0.12455576848" target="_blank" title="http://cerner.vertabase.com/project/document/index.cfm?&0.12455576848">http://cerner.vertabase.com/<wbr></wbr>project/document/index.cfm?&0.<wbr></wbr>12455576848</a></span></b></td></tr><tr bgcolor="#F5F5E2"><td align="right"><span style="font-family: Arial;">Visit Entry Page</span></td><td align="center"></td><td><span style="font-family: Arial;"><a href="http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html" target="_blank" title="http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html">http://hcrenewal.blogspot.com/<wbr></wbr>2014/05/i-could-not-make-this-<wbr></wbr>up-if-i-tried.html</a></span></td></tr><tr><td align="right"><span style="font-family: Arial;">Visit Exit Page</span></td><td align="center"></td><td><span style="font-family: Arial;"><a href="http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html" target="_blank" title="http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html">http://hcrenewal.blogspot.com/<wbr></wbr>2014/05/i-could-not-make-this-<wbr></wbr>up-if-i-tried.html</a></span></td></tr><tr bgcolor="#F5F5E2"><td align="right"><span style="font-family: Arial;">Out Click</span></td><td align="center"></td><td></td></tr><tr><td align="right" valign="top"><span style="font-family: Arial;">Time Zone</span></td><td align="center"></td><td><span style="font-family: Arial;"><a href="http://www.sitemeter.com/?a=stats&&s=s20hcrenewal&v=100&vlr=14&pg=21&r=31" target="_blank">UTC-6:00</a></span></td></tr><tr bgcolor="#F5F5E2"><td align="right" valign="top"><span style="font-family: Arial;">Visitor's Time</span></td><td align="center"></td><td><span style="font-family: Arial;"><span title="Jun 13 2014 10:47:42">Jun 13 2014 10:47:42 am</span></span></td></tr><tr><td align="right"><span style="font-family: Arial;">Visit Number</span></td><td align="center"></td><td align="left"><span style="font-family: Arial;">1,342,222</span></td></tr></tbody></table><br /> -- SS<br /><br />Note: also see my June 16, 2014 followup post at <a href="http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html">http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html</a>

Athens Regional Medical Center: Hospital management is "addressing computer problems" AFTER patients are put at bodily risk, not before, only in response to irate clinicians; then claiming everything will be fixed soon while doctors resign.

(Note: also see my June 16, 2014 followup post at http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html ) Maybe...

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Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

At my May 30, 2013 post "<b>Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients ... CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue</b>" at <a href="http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html">http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html</a>, I lamented that hospital management felt they could ignore clinicians calling for implementation postponement of what they viewed as bad health IT, dangerous to patients, with impunity.<br /><br /><b>Finally, </b>medical professionals stand up to imperial hospital management that, in a perhaps criminally negligent fashion (e.g., see my post on the <b>ECRI Deep Dive Study on Health IT harm</b> at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">this link</a>), ignores its clinicians over too-rapid deployment of health IT.<br /><br />Also see newspaper article at <a href="http://www.cantonrep.com/news/x393137745/Affinity-nurses-seek-delay-on-electronic-records#axzz2WcOMZpvF">http://www.cantonrep.com/news/x393137745/Affinity-nurses-seek-delay-on-electronic-records#axzz2WcOMZpvF</a>.<br /><br />(The hospital management is extolling the safety of the new Cerner system.  What could <i><b>possibly</b></i> go wrong?  -- I'd bet the executives, despite their fiduciary duties towards maintaining a safe hospital environment, have no idea about Cerner defects such as at the FDA MAUDE database; see "<b>MAUDE and HIT Risks: What in God's Name is Going on Here?</b>" at <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html</a> or are familiar with "<b>Medical center has more than 6000 'issues' with Cerner CPOE system in four months" </b>at <a href="http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html">http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html</a>.  Instead, unpaid bloggers do their work for them to protect patients....)<br /><br /><b>See this: </b><br /><br /><div style="text-align: center;">-----------------------------</div><blockquote class="tr_bq"><div class="MsoNormal"><b><span style="font-family: "Times New Roman","serif"; font-size: 14.0pt;">For Immediate Release - June 18, 2013</span></b></div><div class="MsoNormal"><i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">For more information: Michelle Mahon, RN, 234-207-6706 or Liz Jacobs, RN, 510-273-2232</span></i></div><div class="MsoNormal"><br /></div><div align="center" class="MsoNormal" style="text-align: center;"><span style="font-size: large;"><b><span style="font-family: "Times New Roman","serif";">Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday</span></b></span></div><div class="MsoNoSpacing"><br /></div><div class="MsoNoSpacing"><br /></div><div class="MsoNoSpacing"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Affinity Medical Center RNs in Massillon, Ohio are calling on hospital officials to delay the planned June 21 implementation of the Cerner electronic medical records (EMR) system, until the hospital bargains with the nurses and proceeds in a safe manner. </span></div><div class="MsoNoSpacing"><br /></div><div class="MsoNoSpacing"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">The direct-care RNs, represented by the National Nurses Organizing Committee (NNOC) in Ohio, an affiliate of National Nurses United (NNU), say that nurses, the primary users of the complex system, have had insufficient training, which will put patients at risk. The implementation, which has been done without bargaining with NNOC, reflects yet another violation of federal labor law by Affinity, nurses say.</span></div><div class="MsoNoSpacing" style="margin-bottom: 12.0pt;"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;"><br />Nurses have documented their concerns in a detailed letter to hospital officials. Those concerns <b>include woefully inadequate training, short staffing in the first days of the roll out, and the subsequent risk of harm to their patients</b>.  The system, they say, has the potential of violating the Ohio Nursing Practice Act because it doesn’t permit RNs to communicate individualized, potentially life-saving information about their patients. </span></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">The letter, which RNs attempted to deliver to hospital officials on Friday, cites nationally recognized experts in health information technology who reinforce the RNs’ concerns. Most notably, the Institute of Medicine (IOM) has concluded that the failure to include RNs in all steps of this transition is one of the most significant barriers to successful, safe implementation of electronic health records systems. </span></div><div class="MsoNormal"><b><br /></b></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;"><b>Hospital officials have continued to refuse to meet with nurses, and would not accept the letter.  <span style="color: red;"><i>[Willful ignorance? - ed.]</i></span></b> Without bargaining with the union or acknowledging the nurses’ concerns, the hospital added a few more trainings late Friday, but the RNs say that remains far from adequate.</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Over the last few years, American healthcare corporations have invested heavily in information technology (IT) systems, which make up a multi-billion dollar market. </span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">“RNs who actually use these systems day in and day out have found that the kind of care they can provide with this new technology is limited,” said NNOC Co-president Cokie Giles, RN. <b>“The programs are often counterintuitive, cumbersome to use, and sometimes simply malfunction. Nurses are finding that the technology is taking time away from patients and fundamentally changing the nature of nursing.” </b></span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">NNOC/NNU has successfully negotiated clauses in its contracts that allow RNs to play a greater role in reviewing and approving new technologies before they are introduced, and that the new technologies will not supersede RN professional judgment.  </span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">“I have been chosen as a ‘super-user,’ said Amy Pulley, an RN who works in the endoscopy unit of the hospital. “I’m not sure what makes me ‘super’ with the limited training for this complex system that I’ve received. I’m concerned that the manner in which this technology is being implemented may pose serious disruptions in patient care.”</span></div><div class="MsoNormal"><br /></div><div align="center" class="MsoNormal" style="text-align: center;"><b><span style="font-family: "Times New Roman","serif"; font-size: 14.0pt;">Highlights of RN Concerns on the Implementation of the Cerner Electronic Medical Records System at Affinity Medical Center</span></b></div><div align="center" class="MsoNormal" style="text-align: center;"><br /></div><div class="MsoNormal"><b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Inadequate Staffing</span></b></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Several units will be severely short staffed for the transition, despite the fact that the hospital has been planning on the “go live” date for several months. </span></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">The entire hospital and all portions of the system will go live at once, referred to as the “big bang” approach, which has a very low rate of success, rather than implementing it in trial, pilot stages.</span></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">They are utilizing the ‘super-user’ model which will pull nurses from direct-care so they can be available to teach, leaving several units without enough nurses to care for patients.</span></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">The hospital refuses to decrease the number of elective procedures or provide additional staff during the transition time.</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Lack of training </span></b></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Some nurses have received only one day of training.</span></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Super-users have received no education or training in the system beyond what is provided to the other users. </span></div><div class="MsoListParagraph" style="margin-left: .25in;"><br /></div><div class="MsoNormal"><b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Design flaws</span></b></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Placement of the workstations are ill conceived—RNs must turn their back to patients while documenting. </span></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">During one education session, the system crashed because 17 users at one time overloaded it.</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Failure to consult nurses</span></b></div><div class="MsoListParagraph" style="margin-left: .25in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 12.0pt;">·<span style="font: 7.0pt "Times New Roman";">        </span></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Several concerns were brought to management’s attention which they were unable to answer. One example— how will RNs override the system in the event of an emergency? </span></div><div class="MsoListParagraph" style="margin-left: .25in;"><br /></div><div class="MsoNoSpacing"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">Affinity is one of five hospitals in California, Ohio, and West Virginia that are part of one of the nation’s largest for-profit hospital chains, Tennessee-based Community Health Systems where affiliates of NNU are pursuing federal action for significant violations of RN rights. </span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">The National Labor Relations Board held a five-day hearing in May in a complaint filed by the nurses and NNOC over Affinity’s refusal to bargain a first contract and retaliation against RNs for advocating for their patients and their colleagues. A decision by an NLRB administrative law judge is pending. CHS affiliated hospitals in West Virginia and California are facing similar sanction from federal officials. At one of the California hospitals last week, a U.S. District Court judge issued an injunction ordering the hospital to return to negotiations with the RNs.</span></div><div class="MsoNormal"><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt;">CHS is the second largest for-profit hospital chain in the United States, and one of the wealthiest. Over the past five years, CHS reported over $1.5 billion in profits to the Securies Exchange Commission. </span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="color: #1f497d; font-family: "Arial","sans-serif";">Michelle Mahon, RN </span></div><div class="MsoNormal"><span style="color: #1f497d; font-family: "Arial","sans-serif";">National Representative</span></div><div class="MsoNormal"><span style="color: #1f497d; font-family: "Arial","sans-serif";">National Nurses United</span></div><div class="MsoNormal"><span style="color: #1f497d; font-family: "Arial","sans-serif";">mmahon@nationalnursesunited.org</span></div><div class="MsoNormal"><span style="color: #1f497d; font-family: "Arial","sans-serif";">234-207-6706</span></div></blockquote><br />I believe the nurses should strike if their concerns are not heeded.<br /><br />I once worked in a highly-unionized city Transit Authority; I believe the unions would have shut the Authority down in the face of even a fraction of concerns like this that could impact pubic safety - and their own memberships' careers and lives.<br /><br />-- SS<br /><br /><b>6/20/13 addendum:</b><br /><br />I note that this EHR medical device (per FDA) is non-FDA approved, nor vetted by any regulatory agency.  Apparently the hospital believes it has the prerequisite skills and expertise to vet this device for safety.  Who, exactly, will take responsibility for bad outcomes?<br /><br /><div style="font-family: inherit;"><span style="font-size: 100%;">FDA's Chair of the Center for Device and Radiological Health, Jeffrey Shuren, MD JD, stated </span><span style="font-size: 100%;"><span style="font-size: 100%;">explicitly </span>that EHRs were medical devices on Feb. 25, 2010 (see testimony to the HHS Health Information Technology HIT Policy Committee at <a href="http://web.archive.org/web/20120320111030/http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf" target="_blank">this PDF</a>) that:</span></div><div style="font-family: inherit;"><span style="font-size: 100%;"><br /></span> </div><div dir="ltr" style="font-family: inherit;"><span style="font-size: 100%;"> </span></div><blockquote dir="ltr" style="font-family: inherit; margin-right: 0px;"><div dir="ltr"><span style="font-size: 100%;">... Under the <a href="http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm">Federal, Food, Drug, and Cosmetic Act</a>, <b><span style="color: red; font-style: italic;">[that regulates all drug, medical devices, etc. in the United States - ed.]</span> HIT software is a medical device</b>. Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems)... </span><span style="font-size: 100%;"><b>To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices.</b></span></div></blockquote><br /><br />I also note that patient informed consent to its use in their care is likely not being sought.  Should it?  If not, why not?<br /><br />-- SS<br /><br /><b>9/2/2013 addendum</b><br /><br />The comment by "Anonymous August 20, 2013 at 11:24:00" has many characteristics of a sockpuppet (see <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html</a>) - ignoring everything written in the post and expressing perverse and deranged views.  See it, and my response, in the comment section.  A post about an anti-health IT union dispute such as this is a strong potential sockpuppet magnet.<br /><br />-- SS

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

At my May 30, 2013 post " Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients ....

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Tales of the Wayfaring Generic Manager - from Ritz Carlton Hotels to Henry Ford West Bloomfield Hospital to Cancer Treatment Centers of America

In 2006, we <a href="http://hcrenewal.blogspot.com/2006/03/putting-on-ritz.html">wondered</a> what a former hotel manager, Mr Gerard van Grinsven, admittedly known for putting the "wow" back in the Detroit Ritz-Carlton, would be doing as a hospital CEO.  This seemed at the time like a real "wow" example of how <a href="http://hcrenewal.blogspot.com/search/label/generic%20managers">generic managers </a>were taking over health care.  Mr Grinsven had extensive experience in the hospitality field, but no known background in health care. <br /><br /><b>Organic Local Produce, "Wellbeing Centers," Gourmet Dining, Wedding Receptions, and Corporate Functions</b><br /><br />Over the next few years, Mr van Grinsven's Henry Ford West Bloomfield hospital did make a name for itself.  In 2009, Becker's Hospital Review <a href="http://www.beckershospitalreview.com/news-analysis/ceo-gerard-van-grinsven-explains-how-henry-ford-west-bloomfield-hospital-reinvents-the-community-hospital.html">reported</a> on some of Mr Van Grinsven's innovations.  <br /><br />First, he lead an apparent change in the hospital's mission from acute care to recreating:<br /><br /><blockquote class="tr_bq">the hospital experience into one<i> focused on promoting wellbeing and healthy living</i>. The hospital has already begun to realize its mission statement, which reads '<i>to take health and healing beyond the boundaries of imagination</i>.'</blockquote><br />The new hospital apparently was designed to look like a luxury hotel:<br /><br /><blockquote class="tr_bq">The hospital is located on 160 acres of woodlands and is designed to resemble a Northern Michigan lodge. The facility also features a retail 'main street' which looks like an actual main street in a Northern Michigan town and includes stores focused on sleep, pregnancy, organic food and healthy cooking as well as a pharmacy.</blockquote><br />Apparently it is now a favored site for weddings:<br /><br /><blockquote class="tr_bq">The hospital also holds free concerts for the community and has already received <i>nine wedding inquiries. </i></blockquote><br />It had a "wellness center"<br /><br /><blockquote class="tr_bq">Henry Ford West Bloomfield also features a <i>unique, integrated wellness center called Vita. Vita offers acupuncture, therapeutic message, yoga and relaxation classes, an aqua therapy suite, a spa and health coaches who provide lifestyle and exercise consultations</i>. In addition to offering one-time services, the hospital offers memberships to community members to encourage frequent use of the center. </blockquote><br />What really stood out was its food service:<br /><br /><blockquote class="tr_bq">Henry Ford brought in top Michigan chef Matt Prentice to transform traditional hospital food service. The hospital features 24-hour room service for patients, all of which is served by the hospital's <i>on-site gourmet, organic restaurant</i>, Henry's. All food served in the hospital is <i>organic, promotes sustainable agriculture and, in many cases, is procured from local farmers</i>.</blockquote><br />A 2011 <a href="http://management.fortune.cnn.com/2011/03/02/what-hospitals-can-learn-from-the-ritz/">article</a> in Fortune noted that<br /><br /><blockquote class="tr_bq">the hospital is on track to <i>generate millions of dollars a year hosting and catering functions</i> for companies and community groups.</blockquote><br />It all sounds great, if it were describing a luxury hotel.<br /><br />The Fortune article ended with the gushing summation:<br /><br /><blockquote class="tr_bq">While it will be years before anyone can say whether this model works, there's no question that it <i>captures a spirit of innovation </i>that just might be a cure for what ails so many organizations. We are living today through the <i>age of disruption.</i> You can't do big things if you're content with just doing things a little better than everyone else or a little differently from how you've done them in the past. In an era of intense competition and non-stop reinvention, <i>the only way to stand out from the crowd is to stand for something special.</i> Originality has become the acid test of strategy.</blockquote><br />Neither it nor the Becker's rather uncritical discussions dealt with what any of this had to do with the fundamental mission of a hospital, to care for the sick, what it has to particularly do with quality of care, especially care of severely acutely or chronically ill patients, traditionally those whom hospitals were meant to serve.  Would a patient desperately sick from a myocardial infarction (heart attack), stroke, sepsis (bacterial blood stream infection) or the other major ills that bring people to hospitals really care that if he or she were to survive without major sequelae, organic, locally grown food would be served in the hospital's fancy restaurant?  Is there any evidence that provision of any of these fancy hotel amenities would affect important clinical outcomes for such patients?  Could the funds needed for all these fancy hotel services be better spent to improve patients' the the population's health?<br /><br /><b>On to a More Ethically Challenged Environment </b><br /><br />We may never know.  But what we do know is that Mr van Grinsven, having brought "wellness" centers and organic, locally grown, gourmet food to an acute care hospital, is now moving on.<br /><br />Crain's Detroit Business just <a href="http://www.crainsdetroit.com/article/20130426/NEWS/130429902/henry-ford-west-bloomfield-hospitals-van-grinsven-resigns-as-ceo">reported</a>:<br /><br /><br /><blockquote class="tr_bq">Henry Ford West Bloomfield Hospital President and CEO Gerard van Grinsven has resigned from the position effective June 1, according to an internal email sent Friday to employees from Henry Ford Health System President and COO Bob Riney.<br /><br />Van Grinsven is leaving the hospital to <i>become the president and CEO of Chicago-based Cancer Treatment Centers of America,</i> Riney said in the email. He will oversee the CTCA's five hospitals and medical centers in Illinois, Pennsylvania, Oklahoma, Arizona and Georgia. The CTCA is expected to announce van Grinsven's new position later today.</blockquote><br />Henry Ford Health System CEO Bob Riney saluted van Grinsven thus,<br /><br /><blockquote class="tr_bq">'Gerard's leadership talents and his tremendous global experience made<i> the transformation of this innovation and distinctive vision a reality</i>,' Riney told employees in the email.</blockquote><br />He did not apparently mention anything about the quality of care for acutely and chronically ill patients.  The <a href="http://www.prnewswire.com/news-releases/stephen-b-bonner-assumes-new-role-as-ctca-executive-chairman-gerard-van-grinsven-succeeds-as-president--ceo-204883721.html">press release</a> from CTCA proclaimed <br /><br /><blockquote class="tr_bq">'Gerard's arrival is an exciting and dramatic step in the evolution of our leadership that will <i>herald new opportunities for all of our talented Stakeholders</i> and the thousands of patients we serve,' said [executive chairman and former CEO Stephen B] Bonner. 'Our expertise in <i>Patient Empowerment Medicine<span>®</span> and track record implementing change</i> is unparalleled. Nothing we do today is the same as we did two years ago. Gerard is uniquely qualified to provide the leadership required to advance our commitment to patient-centered care in all we do,' concluded Bonner.</blockquote><br />Of course, there was nothing about how van Grinsven's expertise in wellness centers and organic produce would be useful to an organization supposedly devoted to cancer patients, whose care may involve risky treatment choices and who may become desperately ill. <br /><br />There was also nothing about how van Grinsven's background would help CTCA to avoid new ethical misadventures.  Earlier this year, we <a href="http://hcrenewal.blogspot.com/2013/03/the-dangers-of-big-corporate-health.html">posted</a> about issues involving CTCA making unsubstantiated survival claims; promoting "integrative" treatments that are unsupported by evidence; and manipulating survival statistics, in part by turning away patients with poor prognoses.  Of course, it is not clear that given van Grinsven's background he would even understand why such behavior is unethical. <br /><br /><b>Summary</b><br /><br />As a physician, it is hard not to laugh at all this, at least to keep from crying.  As we have noted frequently, health care has been taken over by generic hired managers.  At best, while well meaning, many of them seem clueless about the nature and context of health care, and health care professionals' values.  At worst, the <a href="http://hcrenewal.blogspot.com/search/label/managers%27%20coup%20d%27etat">manager's coup d'etat</a> has turned managers into manager-kings, queens and nobles, while driving up health care costs, and sacrificing the health of patients and the public.  The depth of this phenomenon is demonstrated by the absolute lack of skepticism about the worthiness of a former Ritz-Carlton executive to run either a community hospital or a system of cancer treatment centers. <br /><br />I say once again that true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty. <br /><br /><br />

Tales of the Wayfaring Generic Manager - from Ritz Carlton Hotels to Henry Ford West Bloomfield Hospital to Cancer Treatment Centers of America

In 2006, we wondered what a former hotel manager, Mr Gerard van Grinsven, admittedly known for putting the "wow" back in the Detr...

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10 Years of Pfizer Leadership - "A Saga of Ambition, Intrigue, Backstabbing, and Betrayal"

A remarkable story about mismanagement of health care has appeared in the mainstream media, and most remarkable is that this <a href="http://features.blogs.fortune.cnn.com/2011/07/28/pfizer-jeff-kindler-shakeup/">article</a> in Fortune chronicled 10 years of poor leadership by three CEOs at Pfizer Inc, the world's biggest drug company<br /><br /><strong>The CEO Who Would Not Leave</strong><br /><br />In 2001, William C Steere Jr retired as CEO, but did not really leave, muddying the chain of command:<br /><blockquote>In January 2001, Steere, by then 64 and a company legend, retired as CEO. He handed the job to his handpicked No. 2, Hank McKinnell. <em>Steere stepped aside -- but not out. He received a consulting contract, with an office and secretary at Pfizer headquarters. Most important, Steere was granted the title of chairman emeritus and retained his seat on the Pfizer board. Governance experts widely regard such lingering as a recipe for trouble</em>. Steere would remain a potent influence for another decade, outlasting his two successors.</blockquote><br /><strong>Waffling About How to Support the Pipeline</strong><br /><br />The next CEO was Henry "Hank" McKinnell Jr, who was faced with a declining pipeline of new drugs. His response was to go from one extreme to another:<br /><blockquote>Pfizer's pipeline simply couldn't support the growth the company had promised investors. <em>Three of its blockbusters were about to lose patent protection and face generic competition, meaning their profits would plummet. </em>The biggest issue, of course, was Lipitor -- by 2005, it was bringing in a staggering $12 billion a year, more than a quarter of Pfizer's revenues. The company wouldn't lose its exclusive rights to Lipitor until late 2011, but already Wall Street was wondering how Pfizer could possibly replace it.<br /><br />McKinnell kept boosting R&D budgets,<em> maintaining Pfizer's 'shots on goal' approach -- the more compounds you explored, in theory, the more drugs you'd generate</em>. But drugs can take a full decade to be developed and approved, and nothing big would be ready for years.<br /><br /><em>So McKinnell fell back on the refuge of the desperate pharma CEO: In July 2002 he announced the acquisition of Pharmacia</em>, the industry's seventh-largest company, for $60 billion in stock. </blockquote><br /><strong>A Power Vacuum and the Infighting Begins</strong><br /><br />When that did not work, McKinnell made himself scarce, leading to infighting among the next level of executives:<br /><blockquote>But even as Pfizer struggled to digest this latest meal, <em>McKinnell seemed to spend less and less time at headquarters</em>, becoming head of industry trade groups, funding an institute in Africa to combat AIDS, even writing a book about reforming health care.<br /><br /><em>That left a power vacuum, and Bill Steere, the former CEO, seemed more than willing to fill it.</em> He was a familiar figure at Pfizer's New York headquarters, where he worked out in the basement fitness center and ate lunch in the cafeteria. Steere was always happy to lend an ear and share his views. His retired status and public reserve concealed tremendous influence. 'He says almost nothing,' says a person familiar with Pfizer's board. 'But people look to him to see how he nods and how he moves, because he knows the company better than anyone.'<br /><br />With Pfizer no longer soaring, <em>internal squabbling intensified</em>. Vexed by what he viewed as Steere's meddling, McKinnell even tried to terminate his consulting contract. Steere fended off that move. </blockquote><br />Furthermore, McKinnell's ideas about succession planning led to further infighting:<br /><blockquote>By 2005, McKinnell was already making plans for his succession. He promoted three executives to vice chairman,<em> setting off what would become a long and increasingly bitter contest to choose the next CEO</em>.</blockquote><br /><strong>More Waffling Over Acquisitions Versus Spin-Offs</strong><br /><br />As Pfizer's stock price continued to fall, the board pushed McKinnell into rretirement in 2006, and replaced him with Jeffrey Kindler. However, Kindler also could not make up his mind whether to grow or shrink the company:<br /><blockquote><em>Suddenly desperate to shrink the company -- which had just completed two giant mergers</em> -- Kindler announced plans for brutal layoffs that included axing 20% of the vaunted U.S. sales force.<br /><br /><em>Yet even as he was making massive cuts, Kindler was also pondering acquisitions</em>, toying with alternative strategies. The first was a 'string of pearls' approach -- a handful of smaller purchases, each aimed at filling a single strategic gap, such as biotech. The second strategy was yet another megadeal -- namely, buying Wyeth. That company had $23 billion in sales, strength in vaccines and biotech, a large over-the-counter products division, and several blockbusters of its own, including Prevnar, an antibacterial vaccine for children.<br /><br />But after more than a year of on-and-off debate, <em>Kindler just couldn't make up his mind</em>.</blockquote><br /><strong>Inconsistent Leadership for Research and Development</strong><br /><br /><blockquote>the process of overhauling R&D was <em>a messy one</em>. <em>Kindler shuffled through three research chiefs during his 4 1/2 years as CEO.</em> He closed six R&D sites, then halted research in 10 disease areas even while setting a new goal of launching four new internally developed drugs a year by 2010. He split the research operation in two -- setting up a separate unit for biologic drugs (and launching an expensive new facility in San Francisco) -- <em>only to reverse the decision</em> 30 months later after taking on Wyeth's big biotech operation.<br /><br />Among the shuttered Pfizer sites was one at Ann Arbor, the birthplace of Lipitor. Says Bruce Roth, the scientist known as <em>'the father of Lipitor,' who lost his job when the Ann Arbor site closed </em>and now works for Genentech: 'When every 18 months you throw the organization up in the air and are shifting therapeutic areas or closing sites, <em>you have this period of turmoil when everybody in the organization is paralyzed. You need some continuity to do science.</em>'<br /><br />Kindler was struggling for answers in a complex industry where his own experience was limited. In an effort to bring in fresh thinking, <em>Kindler spun his leadership team like a top</em>. Company veterans Shedlarz, chief medical officer Dr. Joseph Feczko, and CFO Alan Levin departed. Frank D'Amelio, Kindler's new CFO, arrived from Lucent. Sally Susman, his new communications chief, had worked at Estée Lauder (EL). His new general counsel, Allen Waxman, resigned abruptly for "personal reasons" after just one year; replacing him was Amy Schulman, a high-profile litigator at DLA Piper.</blockquote><br /><strong>In Thrall to a Questionable Subordinate</strong><br /><br />The Fortune article devoted considerable space to document Mr Kindler's trust in a questionable subordinate.<br /><blockquote>Perhaps the only thing as destructive to Kindler as his inability to trust his colleagues was the one Pfizer executive in whom he did place his trust: Mary McLeod. The head of human resources under Kindler, McLeod would leverage her relationship to the CEO to become both his emissary and a power in her own right. Kindler's loyalty to her would undercut him at a crucial moment. </blockquote><br />Kindler did not seem to realize why she had lost her former position:<br /><blockquote>Her tenure at Schwab had ended disastrously, though there's no sign Kindler knew that when he brought McLeod in. As Schwab's head of HR and chief of staff to CEO David Pottruck in the early 2000s, McLeod had proved toxic, according to six members of Pottruck's executive team. They say she isolated him from other points of view and went to extraordinary lengths to remove rivals. Meanwhile she criticized him behind his back and bragged that she had the CEO under her thumb.<br /><br />After an internal investigation, Pottruck fired McLeod in 2004, he confirms. In an e-mail sent to McLeod the day of her termination, read aloud to Fortune, Pottruck wrote: <em>'The issues are about the perceptions others have of you around character, integrity and divisiveness … There is a perception that you do not tell the truth.'</em></blockquote><br />Ms McLeod's ascendancy seemed to create toxicity:<br /><blockquote>McLeod seemed uninterested in the details of how the streamlined department would actually function. Even top deputies say <em>she was virtually unapproachable</em>, preferring to communicate by e-mail and quarterly videocast.<br /><br /><em>McLeod's primary focus was the care and feeding of the CEO</em>. She became Kindler's protector and surrogate, whispering in his ear, controlling access to him, delivering his blunt messages. Kindler admiringly called her 'Neutron Mary,' after his hero, Jack Welch. McLeod seemed to encourage his harshest nature, telling him, according to a person who was present, that one senior executive was 'a B player,' another too ambitious, someone else a 'crybaby.'<br /><br />McLeod also publicly denigrated her employees, announcing at one town hall meeting in 2008 that two big positions would have to be filled from outside because no one inside Pfizer was capable of doing the job.</blockquote><br />Yet Mr Kindler seemed to make sure Ms McLeod's compensation reflected his good relationship with her, not her relationship with the rest of the company:<br /><blockquote><em>McLeod's emoluments were so lavish they might make her one of the company's five most compensated employees, which would require Pfizer to disclose the details in its annual proxy statement.</em> In early 2008 company governance chief Peggy Foran investigated the issue and tallied nearly $1 million in payments to McLeod, including those relating to her various houses, the helicopter use, and a large bonus to buy her out of a consulting partnership. Then there was McLeod's salary and regular bonus of $900,000 and restricted stock and options.</blockquote><br />As Mr Kindler continued to flounder, his excess faith in Ms McLead undercut his support among other executives:<br /><blockquote>loyalty to the CEO among members of his 'executive leadership team,' or ELT, was growing tenuous. One catalyst for the disaffection was Mary McLeod. With the CEO's support, she had become feared inside Pfizer. Kindler seemed blind to her shortcomings, opening up a divide within the ELT. Says one executive: <em>'There was Mary and Jeff, and then there was the rest of us.'</em></blockquote><br />When the board finally realized how much dysfunction Mr Kindler's trust in Ms McLead was causing, it was the beginning of the end of his CEO-ship. Her increasingly bizarre behavior lead to an inquiry:<br /><blockquote>The two-week investigation was conducted by Bart Friedman, an attorney with Cahill Gordon & Reindel who specializes in corporate governance work. After interviewing all of McLeod's direct reports, Friedman found nothing illegal. He did, however, conclude that <em>HR was thoroughly dysfunctional, and riven by inept management. In his view, this was a simple case of incompetence.</em><br /><br />On Wednesday, Dec. 1, Pfizer's executive team gathered for a day of meetings with the CEO. Mary McLeod was missing. After hearing Friedman's report, Kindler had finally parted ways with his controversial HR chief -- though not without a generous severance package.<br /><br />Now it was Kindler whose job was threatened.</blockquote><br /><strong>Summary: Per Fortune</strong><br /><br /><blockquote>Indeed, what has occurred at the company -- whose $68 billion in annual sales are built on blockbuster drugs such as Lipitor and Viagra -- is extraordinary. Once a Wall Street darling and corporate icon, <em>Pfizer has tumbled into disarray</em>. In the decade that ended with Kindler's departure, its stock price sagged from a high of $49 down to $17 and its drug pipeline dried up (problems the company continues to grapple with today). <em>Pfizer lost its way, stumbling through a frantic series of zigzags in the hopes of finding new blockbusters to sustain its prodigious profits in the future.</em><br /><br /><em>Meanwhile, its managers descended into behavior that would do Shakespeare -- or Machiavelli -- proud.</em> There was the ex-CEO who couldn't relinquish his power and quietly maneuvered to undercut two successors he had helped install. Then there was the human resources chief who divided the staff rather than uniting it. Most of all, there was Kindler himself, a bright man with some fresh ideas for reforming Pfizer but a person who agonized over decisions even as he second-guessed everybody else's actions. The story of Jeff Kindler's tumultuous tenure at Pfizer is <em>a saga of ambition, intrigue, backstabbing, and betrayal</em> -- all of it exacerbated by a board that allowed the problems to fester for years.</blockquote><br /><strong>Health Care Dysfunction Made Visible</strong><br /><br />In <a href="http://www.ejinme.com/article/S0953-6205%2803%2900029-3/abstract">"a cautionary tale: the dysfunction of American health care,"</a> published in 2003, I postulated causes of our country's health care malaise based on qualitative interviews with physicians and cases I found that instantiated their concerns. One major concern was about "ill-informed, incompetent, self-interested, or even corrupt leadership." Since then, on Health Care Renewal, we have discussed a large number of cases of such bad leadership. However, most cases have come from news reports which cover only a single incident or small slice of time. The Fortune article on Pfizer covered 10 years of leadership that at least appeared ill informed and of doubtful competence.<br /><br />Given that Pfizer is the world's largest pharmaceutical company this long duration case narrative does underscore our concerns. That such an important health care organization could be so badly lead for so long suggests that our fears about the problems of leadership of large health care organizations were, if anything, understated. As the Fortune article's authors put it:<br /><blockquote><em>Pfizer is an enterprise with the noble calling of easing pain and curing disease. Yet its leaders spent much of their time in the tawdry business of turf wars and political scheming</em>.</blockquote><br />When these sorts of sentiments start appearing in business magazines, health care professionals and policy makers ought to realize how overdue are our serious efforts to improve leadership and governance in health care.

10 Years of Pfizer Leadership - "A Saga of Ambition, Intrigue, Backstabbing, and Betrayal"

A remarkable story about mismanagement of health care has appeared in the mainstream media, and most remarkable is that this  article in Fo...

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"Good Managers" And Complex Technological Projects - Recipe for Poor Results?

<p>Once more on the topic of CIO’s and other health IT leaders lacking in solid healthcare informatics and clinical credentials, there’s this letter in today’s WSJ that I think says it all about complex technological projects, including (perhaps especially) healthcare IT.</p><p>Emphases mine:</p><p><a href="http://topics.wsj.com/article/SB20001424052748704694004576019311025319804.html" rel="nofollow"></a></p><blockquote><p><a href="http://topics.wsj.com/article/SB20001424052748704694004576019311025319804.html" rel="nofollow"><br /></a></p><span style="font-style: italic;">Wall St. Journal</span><br /><span style="font-style: italic;">Letter to the Editor</span><br /><span style="font-style: italic;">Dec. 16, 2010</span><br /><a style="font-style: italic;" href="http://topics.wsj.com/article/SB20001424052748704694004576019311025319804.html"><br />Manhattan Spirit for Cyber Defense </a><i><br /><br />In “How to Fight and Win the Cyberwar” (op-ed, Dec. 6), Mortimer Zuckerman uses the analogy of the Manhattan Project to build the atomic bomb in World War II and suggests forming a “Cyber Defense Administration” (CDA).</i><i><br /><br />We need to keep in mind how the Manhattan Project managed to succeed in achieving its objectives. The direction and top management of the project was by scientists like Robert Oppenheimer, who understood the scientific details of the project, and project director Gen. Leslie Groves, who made sure the scientists got what they wanted. This is not like any bureaucracy in the U.S. government today.</i><i><br /><br />I would visualize a CDA more as a TSA- or EPA-type bureaucracy <span style="font-weight: bold;">with a politically sensitive lawyer or bureaucrat at the top, and having to go down two or more administrative levels before you find the first Ph.D.-level computer scientists </span>with a history of serious research and publications in computer/network security. The head of the CDA would probably be clueless about the computer science details and would have no basis for making rational decisions. This is a field where the devil is in the details, and to truly understand those details requires much more than bureaucratic and political skills.</i><i><br /><br />Whoever created the Stuxnet worm that attacked Iran’s nuclear program’s computers probably was not managed by a bureaucrat, but by a team of very high-level scientists who clearly understood the details. Countries like China often have real experts running their organizations, <span style="font-weight: bold;">not just politically smooth bureaucrats who go from job to job with a false theory that a “good manager can manage anything.”</span></i><i><br /><br />In reality, especially in a field like cyber security, <span style="font-weight: bold;">a good manager can only manage what he understands.</span> <span>Our bureaucrats will <span style="font-weight: bold;">lose the cyberwar against scientists who understand the details.</span></span></i><i><br /><br />Dallas Weaver</i><i><br /><br />Huntington Beach, Calif.</i></blockquote><p><i></i></p><br />It is a bureaucratic conceit to think that a "good manager" can manage major healthcare IT projects - or pharmaceutical companies - or anything else outside their core competencies.<br /><br />This holds true even assuming, at best, that one of their "core competencies" is <a href="http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.64.2655&rep=rep1&type=pdf">competency itself</a> (warning: PDF on the <a href="http://en.wikipedia.org/wiki/Dunning%E2%80%93Kruger_effect">Dunning-Kruger effect</a> on<span style="font-weight: bold;"> </span><span>i</span>llusory superiority).<br /><br />-- SS

"Good Managers" And Complex Technological Projects - Recipe for Poor Results?

Once more on the topic of CIO’s and other health IT leaders lacking in solid healthcare informatics and clinical credentials, there’s this ...

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BLOGSCAN - FDA don't need no smart old people 'round

<div style="color: rgb(0, 153, 0);" dir="ltr">We have posted numerous times about the requirement for seasoned expertise (the kind that only comes with age) in healthcare leadership.<br /><br />FDA, CDC and other HHS agencies may have different ideas:<br /><span style="text-decoration: underline;"><br /></span><a href="http://www.blogger.com/redir.aspx?C=418aac679f044cfda11d53292ee8adea&URL=http%3a%2f%2fgooznews.com%2f%3fp%3d2194" target="_blank"></a></div><blockquote style="color: rgb(0, 153, 0);"><div class="meta"><a href="http://www.blogger.com/redir.aspx?C=418aac679f044cfda11d53292ee8adea&URL=http%3a%2f%2fgooznews.com%2f%3fp%3d2194" target="_blank">http://gooznews.com/?p=2194</a><span style="font-weight: bold;"><br /><br /></span><span style="font-weight: bold;">Age Purge in FDA Press Office?</span><br />December 5, 2010<br />By <a title="Posts by GoozNews" href="http://www.blogger.com/redir.aspx?C=418aac679f044cfda11d53292ee8adea&URL=http%3a%2f%2fgooznews.com%2f%3fauthor%3d1" target="_blank">GoozNews</a><br /><br />FDA Webview (subscription required) reports that the new FDA associate commissioner for external affairs, Beth Martino, 31, a former Kansas aide to HHS secretary Kathleen Sebelius, has conducted a purge of senior specialists, all aged over 50, in her office and in the press office. The abrupt removals were made to make room for younger people closer to Martino’s own age, the trade journal reports. “She’s uncomfortable with people who know more than she does,” a source told FDA Webview.<br /><br />Three of the displaced staffers, public affairs officers Elaine Gansz Bobo, 52, Dick Thompson, 65, a former Time magazine science editor, and Ira Allen, 62, a seasoned health care journalist, were offered the choice of being terminated as probationary hires for fabricated “incompetence” or resigning. Similar purges are reportedly occurring at other HHS agencies, including Centers for Disease Control.<br /><br />Neither Martino nor FDA senior deputy commissioner Joshua Sharfstein, whose duties include chairing the FDA’s transparency initiative, responded to FDAWebview’s request for comment.</div></blockquote><div dir="ltr"><div class="post" id="post-2194"><div class="entry"><p style="color: rgb(0, 153, 0);"></p> <p style="color: rgb(0, 153, 0);">If this story is true, it is not only illegal age discrimination under the Age Discrimination in Employment Act of 1967 (<a href="http://www.eeoc.gov/facts/age.html">ADEA</a>), it is deleterious to the appropriate functioning of federal agencies charged with safeguarding public health - via <span style="font-weight: bold;">talent mismanagement.</span></p><p><span style="color: rgb(0, 153, 0);">-- SS</span></p></div></div></div>

BLOGSCAN - FDA don't need no smart old people 'round

We have posted numerous times about the requirement for seasoned expertise (the kind that only comes with age) in healthcare leadership. FDA...

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Prominent Health Care Policy Advice from People Sans Health Care Expertise

It is two days after the US Thanksgiving holiday, and one thing I am thankful for is the continued hilarity generated by health care corporate CEOs who pretend to be health care experts.  Of course this all really is not so funny, because the bogus expertise appears not in MAD Magazine, but in the most respected media outlets with the most influence over health care policy.<br /><br /> This week's example comes from the Wall Street Journal's vaunted CEO Council.  A <a href="http://online.wsj.com/article/SB10001424052748703688704575620850148494216.html">summary</a> of its health care panel appeared early this week in that newspaper.<br /><br />The panel included Angela Braly President and CEO, Wellpoint Inc., William A. Hawkins Chairman and CEO, Medtronic Inc., and Klaus Kleinfeld Chairman and CEO, Alcoa.  Angela Braly, a lawyer with no obvious record of direct experience in health care or related fields (see her bio <a href="http://www.wellpoint.com/business/bios.asp?officerName=Angela_Braly">here</a>), received total compensation from WellPoint of more than $13 million in 2009, while presiding over various snafus and ethical missteps (most recently <a href="http://hcrenewal.blogspot.com/2010/08/being-health-insurance-executive-means.html">here</a>, and with a further catalog <a href="http://hcrenewal.blogspot.com/search/label/WellPoint">here</a>.)   William Hawkins, who has an undergraduate degree in engineering, and an MBA, <a href="http://www.startribune.com/business/98645844.html">received</a> total compensation from Medtronic of over $9 million in fiscal 2010.  His direct involvement in health care or related fields apparently ended after his undergraduate years, when he was said to have done research in pathology (see his bio <a href="http://wwwp.medtronic.com/Newsroom/Biography.do?itemId=1100621535750&lang=en_US">here</a>).   He presided over Medtronic's <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">settlement </a>of thousands of patients' lawsuits that alleged injuries due to a faulty lead on one model of a Medtronic implantable cardiac defibrillator for over $200 million.  The company's other recent questionable activities may be found <a href="http://hcrenewal.blogspot.com/search/label/Medtronic">here</a>.  Dr Kleinfeld's doctorate is in strategic management, but he has no obvious health care background (see his bio <a href="http://www.alcoa.com/global/en/about_alcoa/corp_gov/directors/Kleinfeld.asp">here</a>.)   (The panel apparently had a "subject expert," Dr Risa Lavizzo-Mourey, a physician who is now CEO of the Robert Wood Johnson Foundation, but she was not quoted directly in the WSJ edited transcript.)<br /><br />So what could we expect from a panel on health care that included no one with direct experience or expertise in health care, but two CEOs who managed to become extremely wealthy courtesy their employment by health care companies?  <br /><br />Here is Ms Braly on changing incentives:<br /><blockquote>This really gets to the fact that right now we have a fee-for-service payment system, so we pay for quantity rather than quality. And very importantly, we think we need to redesign the way in which we reimburse for health care.</blockquote><br />So,<br /><blockquote>Reimbursement could come in the form of accountable care organizations or patient-centered medical homes or pay-for-performance or risk sharing. There are a number of ways—and we didn't want to be completely prescriptive in terms of what that reimbursement formula would be.</blockquote><br />The issue is not quantity versus quality, but cognitive, including primary care vs procedures. Ms Braly completely ignores how the government takes only the advice of the RUC to set physician payments, and how her company just apes that example (see posts <a href="http://hcrenewal.blogspot.com/search/label/RUC">here</a>). Ms Braly also completely ignored how her company could actually try to change reimbursement on its own. There is no law that says it must follow the example set by Medicare. <br /><br />So what she said about changing "delivery incentives" is just nonsense, to use a polite term.<br /><br />Then we have Dr Kleinfeld ostensibly on transparency, but really on thinking about health care as if it were done on a production line:<br /><blockquote>Let me first talk about the transparency aspect. It was very informative to hear from those that are in the industry how big a variation you have in practices across the board.<br /><br />If I were to look at a set of factories that make the same thing, and one does it in five days and the other one in 10 days, and the one that does it in five days is cheaper than the one that does it in 10 days, why would I not bring everybody down to the five days?<br /><br />So the question is, what hinders the health-care industry from applying the same mechanics? There was agreement that today for every important disease category there are also quality indicators that are accepted that you could use to see what is the quality delivered.<br /><br />Once you control the process, once you bring the quality up, the costs go down.</blockquote><br />Dr Kleinfeld does not seem to realize that health care involves taking care of unique patients. Even when patients have common problems, they have unique mixtures of other medical problems and personal characteristics. The physician's most basic pledge is to do what is best for each individual patient. Treating them as if they were identical widgets on a production line makes absolutely no sense.  One cannot apply the "same mechanics" that apply on a production line, because actually taking care of patients is not done, and does not at all resemble what happens on a production line. It goes without saying that Dr Kleinfeld seems to have no idea how complex and fraught with error the process of measuring quality in health care actually is. <br /><br />His remarks again, to put it politely, were nonsense.<br /><br />Finally, there was Mr Hawkins in a similar vein:<br /><blockquote>Contrary to popular belief, we actually have very good medical care in this country, and with the proliferation of evidence-based medicine, we have determined that there are best practices for how we can treat hypertension or some of the neurodegenerative diseases or diabetes. And the reality is, as you look across different systems, there's a lot of variability in what people are doing.<br /><br />We talked about the importance of publishing or being very clear about what are the best practices for dealing with hypertension, and then making sure that we have the means by which people will be held accountable moving forward in that area.</blockquote><br />Maybe we should acknowledge that at least Mr Hawkins tried to concentrate on hypertension, which may have a slightly more secure evidence base than some other conditions. But the implication still is that there are "best practices" when the complexity of real patients in a real health care context makes figuring out what really is best for individual patients very challenging. Maybe that is why we used to try to leave such decisions up to doctors, other health professionals, and their patients.<br /><br />However, it seems that the CEOs of big health care corporations seem to feel the need to justify their ridiculous total compensation by opining on health care topics that are completely beyond their experience, training, and expertise. The real problem is that probably because of the assumption that those huge salaries must correlate with huge expertise and intelligence, their opinions are taken seriously. The quotes above did not come from MAD Magazine. They came from a highly respected and prestigious conference sponsored by and whose results were published by the Wall Street Journal.<br /><br />To truly reform health care, we need to stop pretending that general business or law training makes someone a health care expert, and that being paid a lot of money by a health care corporation makes one a bigger health care expert.   We need to go back to developing health care policy with the help of people who actually know something about health care, and who are not paid by particular health care corporation to support their vested interests. 

Prominent Health Care Policy Advice from People Sans Health Care Expertise

It is two days after the US Thanksgiving holiday, and one thing I am thankful for is the continued hilarity generated by health care corpora...

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

Additional detailed answers to the questions I raised <a href="http://hcrenewal.blogspot.com/2010/11/ehreventorg-web-site-to-collect-ehr_15.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/11/emrevent-survey-amateurism-bias-or.html">here</a> about a new site <span style="font-weight: bold;">EHRevent.org</span>, for reporting of healthcare IT-related medical errors, can now be found at a HIStalk interview entitled "<span style="font-weight: bold;">HIStalk Interviews Edward Fotsch MD, CEO, PDR Network (EHR Event)</span>" <a href="http://histalk2.com/2010/11/22/histalk-interviews-edward-fotsch-md-ceo-pdr-network-ehr-event">at this link</a>.<br /><br />It is an interesting interview. I certainly find the <span style="font-style: italic;">recognition of need</span> for an EHR/clinical IT problems reporting service a major cultural advancement in healthcare.<br /><br />It's still unclear to me how -- and why -- this organization originated with little to no public knowledge and involvement, especially considering the organization types mentioned below that participated, and how it will function in interactions with myriad healthcare IT stakeholders.<br /><br />Here's an explanation by Dr. Fotsch:<br /><br /><blockquote><p>... We work with a not-for-profit board called the iHealth Alliance. They Alliance is made up of <span style="font-weight: bold;">medical society executives, professional liability carriers, and liaison representatives from the FDA</span>. They govern some of the networks that we run, and in exchange for that, help us recruit physicians. Professional liability carriers, for example, promote our services that send drug alerts to doctors because that’s good and protective from a liability standpoint.</p> <p>In the course of our conversations with them roughly a year ago, when we were talking about adding some drug safety information into electronic health records, we came across the fact that there were <span style="font-weight: bold;">concerns from the liability carriers</span> that there was <span style="font-weight: bold;">no central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records.</span> <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"><br /></span></p><p><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Translation: the carriers saw their losses potentially increasing as a result of litigation arising from EHR-related lawsuits, and decided to do something proactive- ed.] </span><br /></p><p>They were interested in creating a single place where they could promote to their insured physicians that they could report adverse EHR events. Then it turned out that <span style="font-weight: bold;">medical societies had similar concerns</span>. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"><br /></span></p><p><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[That must have been one of the best-kept secrets on Earth considering the promotion EHR's have received as a miracle-working technology, and the lack of expression of concerns from those societies - ed.]</span><br /></p> <p>Rather than have each of them create a system, the Alliance <span style="font-weight: bold;">took on a role</span> of orchestrating all of the interests, including some interest from the FDA and ONC in creating an electronic health record problem reporting system. <span style="font-weight: bold;">That’s how it came into play.</span></p> <p>Our role in it, in addition to having a seat on the iHealth Alliance board, was really in network operations — in running the servers, if you will, which didn’t seem like a very complicated task. Since business partners we rely on for our core business were interested in it, it was easy to say yes. It frankly turned out to be somewhat more complicated than we originally thought <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[I predict they haven't seen anything yet; wait until they get knee deep into real world EHR issues - ed.]</span>, but now it’s up and available.</p></blockquote><p></p><br />While I find the recognition of need for an EHR/clinical IT reporting service a major advancement, I am nonetheless troubled by certain statements made by Dr. Fotsch. They seem at odds with the theoretic and empirical findings of medical informatics, social informatics, human-computer interaction and other fields relevant for health IT evaluation, and/or seem to demonstrate biases about HIT. My comments are in red italics:<br /><br /><p></p><blockquote><p>Fotsch:</p> <p>… Probably what we’re seeing more often than not, the real challenge with EHRs like any technology, <b>turns out to be some form of user error.</b> <i><br /></i></p><p><i style="font-weight: bold; color: rgb(255, 0, 0);">[What about contributory or causative designer error? – ed.]</i><br /></p><p>“I didn’t know it would do that"<br /></p><p><i style="font-weight: bold; color: rgb(255, 0, 0);">[Why did the user not know? Lack of training, poor manuals, or overly complex information systems lacking informative messages and consistency of control-action relationships, as an example? -ed]</i><br /></p><p>... or “I didn’t know that it pre-populated that" <i><br /></i></p><p><i style="font-weight: bold; color: rgb(255, 0, 0);">[Why did it pre-populate? Was that inappropriate for the clinical context,</i> <span style="font-style: italic; font-weight: bold;"><span style="color: rgb(255, 0, 0);">such as</span> </span><a style="font-style: italic; font-weight: bold;" href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_24.html">in this example</a><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">?]</span><br /></p><p>... or “I didn’t know I shouldn’t cut and paste"<br /></p><p><i style="font-weight: bold; color: rgb(255, 0, 0);">[Then why did the software designers enable cut and paste, without some informative message on overuse, such as length of text cut and pasted?– ed.]</i><br /></p><p>... or “I wasn’t paying attention to this"<br /></p><p><i><span style="font-weight: bold; color: rgb(255, 0, 0);">[Perhaps due to distractions from</span> <a style="font-weight: bold;" href="http://www.tinyurl.com/hostileuserexper" rel="nofollow">mission hostile user interfaces</a><span style="font-weight: bold;">?</span><span style="font-weight: bold; color: rgb(255, 0, 0);"> -ed]</span></i><br /></p><p>... or maybe the user interface was a <b>little confusing</b><span style="font-style: italic;"></span><i><br /></i></p><p><i style="font-weight: bold; color: rgb(255, 0, 0);">[What is "a little confusing?" (Is that like "A little pregnant?) And why was it confusing? User intellectual inadequacy, or software design issues leading to cognitive overload? - ed.]</i><br /></p><p>Actual software errors appear to be the exception rather than the rule as it relates to EHR events.<br /></p><p style="font-weight: bold; color: rgb(255, 0, 0);"><i>["Actual software errors" are defined as, what, exactly--? Loss of database relational integrity as a result of a programming error, as apparently recently happened at Trinity Health, a large Catholic hospital chain as reported in HIStalk? Memory leaks from poor code? Buffer overflows? What?]</i> </p><p>That’s at least as I understand it. <i><br /></i></p><p style="font-weight: bold; color: rgb(0, 0, 0);"><i style="color: rgb(255, 0, 0);">[Understand it from whom? Hopefully not from me </i><span style="font-style: italic;"><span style="color: rgb(255, 0, 0);">or my</span> <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">extensive website</a> <span style="color: rgb(255, 0, 0);">on the issues - ed.]</span></span></p></blockquote><p style="font-weight: bold; color: rgb(0, 0, 0);"><br /></p><p style="font-weight: bold; color: rgb(0, 0, 0);">In summary, <span style="font-weight: normal;">a "blame the user" attitude seems apparent. There appears to be little acknowledgment of the concept of IT "errorgenicity" - the capacity of a badly designed or poorly implemented information system to <span style="font-weight: bold;">facilitate error</span>, and of the systemic nature of errors in complex organizations to which ill-done IT can contribute.<br /></span></p><p style="font-weight: bold; color: rgb(0, 0, 0);"><span style="font-weight: normal;">These are concepts understood long ago in mission critical settings, as in this mid 1980's piece from the Air Force cited in my previously-linked <a href="http://www.tinyurl.com/hostileuserexper">eight part series on mission hostile health IT</a>:<br /></span></p><p style="font-weight: bold; color: rgb(0, 0, 0);"><span style="font-weight: normal;"></span></p><blockquote><p style="font-weight: bold; color: rgb(0, 0, 0);"><span style="font-weight: normal;"><br /></span></p><p class="reference"><span style="font-weight: normal;"><span style="font-weight: bold;">From "<a href="http://hcibib.org/sam/">GUIDELINES FOR DESIGNING USER INTERFACE SOFTWARE</a>"</span><br /><span style="font-weight: bold;">ESD-TR-86-278</span><br /><span style="font-weight: bold;">August 1986</span><br />Sidney L. Smith and Jane N. Mosier<br />The MITRE Corporation<br />Prepared for Deputy Commander for Development Plans and Support Systems, Electronic Systems Division, AFSC, United States Air Force, Hanscom Air Force Base, Massachusetts.<span style="text-decoration: underline;"><span style="font-weight: bold;"></span></span></span><a href="http://hcibib.org/sam/"></a><br /></p><p style="font-weight: bold;" class="reference">... SIGNIFICANCE OF THE USER INTERFACE</p><p class="reference">The design of user interface software is not only expensive and time-consuming, but it is also critical for effective system performance. To be sure, users can sometimes compensate for poor design with extra effort. Probably no single user interface design flaw, in itself, will cause system failure. <span style="font-weight: bold;">But there is a limit to how well users can adapt to a poorly designed interface.</span> As one deficiency is added to another, the cumulative negative effects may eventually result in system failure, poor performance, and/or user complaints.</p><p class="reference">Outright system failure can be seen in systems that are underused, where use is optional, or are abandoned entirely. There may be retention of (or reversion to) manual data handling procedures, with little use of automated capabilities. When a system fails in this way, <span style="font-weight: bold;">the result is disrupted operation, wasted time, effort and money, and failure to achieve the potential benefits of automated information handling.</span><br /></p><p class="reference">In a constrained environment, such as that of many military and commercial information systems, users may have little choice but to make do with whatever interface design is provided. There the symptoms of poor user interface design may appear in degraded performance. <span style="font-weight: bold;">Frequent and/or serious errors in data handling may result from confusing user interface design <span style="color: rgb(255, 0, 0); font-style: italic;">[in medicine, this often translates to reduced safety and reduced care quality - ed.] </span></span>Tedious user procedures may slow data processing, resulting in longer queues at the checkout counter, the teller's window, the visa office, the truck dock, <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[the hospital floor or doctor's office - ed.]</span> or any other workplace where the potential benefits of computer support are outweighed by an <span style="font-weight: bold;">unintended increase in human effort.</span><br /></p><p class="reference">In situations where degradation in system performance is not so easily measured, symptoms of poor user interface design may appear as user complaints. The system may be described as <span style="font-weight: bold;">hard to learn, or clumsy, tiring and slow to use</span> <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[often heard in medicine, but too often blamed on "physician resistance" - ed.]</span> The users' view of a system is conditioned chiefly by experience with its interface. If the user interface is unsatisfactory, the users' view of the system will be negative regardless of any niceties of internal computer processing. </p></blockquote><p class="reference"></p><p class="reference"><a href="http://hcibib.org/sam/"></a></p><p class="reference"></p><p style="font-weight: bold; color: rgb(0, 0, 0);"><span style="font-weight: normal;"><br /></span></p><p style="font-weight: bold; color: rgb(0, 0, 0);"><span style="font-weight: normal;">I am not entirely happy when the CEO of an organization taking on the responsibility of being a central focus for EHR error reporting makes statements that are consistent with unfamiliarity with important HIT-relevant domains, as well as a possible pro-IT, anti-user biases.<span style="font-weight: bold;"><br /></span></span></p><p style="font-weight: bold; color: rgb(255, 0, 0);"><span style="font-weight: normal; color: rgb(51, 51, 51);">For that reason as well as the other questions raised at my prior posts (such as the onerous legal contract and apparent lack of ability of the public to easily view the actual report texts themselves), I cannot recommend use of their site for EHR problems reporting.<br /></span></p><p style="font-weight: bold; color: rgb(255, 0, 0);"><span style="font-weight: normal; color: rgb(51, 51, 51);">I recommend the continued use of the FDA facilities until such time as a compelling argument exists to do otherwise.</span><br /></p><p style="font-weight: bold; color: rgb(255, 0, 0);"><span style="font-weight: normal; color: rgb(0, 0, 0);">-- SS</span></p><p style="font-weight: bold; color: rgb(51, 0, 51);">Addendum 11/28/10:</p><p style="font-weight: bold; color: rgb(255, 0, 0);"><span style="font-weight: normal; color: rgb(51, 0, 51);">This passage ends the main essay at my site "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</a>" and is quite relevant here:</span><br /></p><p class="MsoNormal"><span style="font-family:Arial;"></span></p><blockquote style="font-family: arial;"> <p class="MsoNormal">... An article worth reviewing is "Human error: models and management", James Reason (a fitting name!), BMJ 2000;320:768-770 (18 March), <a href="http://www.bmj.com/cgi/content/full/320/7237/768">http://www.bmj.com/cgi/content/full/320/7237/768</a>:</p><p class="MsoNormal">Summary points:<br /></p><ul><li>Two approaches to the problem of human fallibility exist: the person and the system approaches<br /></li></ul><p class="MsoNormal"></p><ul><li>The person approach focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness </li></ul><ul><li>The system approach concentrates on the conditions under which individuals work and tries to build defenses to avert errors or mitigate their effects</li></ul><ul><li>High reliability organizations---which have less than their fair share of accidents---recognize that human variability is a force to harness in averting errors, but they work hard to focus that variability and are constantly preoccupied with the possibility of failure.</li></ul><p class="MsoNormal"><o:p></o:p><!--[if !supportLists]--></p></blockquote><span style="font-family:Arial;">-- SS<br /><!--[if !supportLineBreakNewLine]--></span><p style="font-weight: bold; color: rgb(255, 0, 0);"><br /></p>

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

Additional detailed answers to the questions I raised here and here about a new site EHRevent.org , for reporting of healthcare IT-relate...

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