healthy4u: healthcare IT safety

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;">(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>) </div> Maybe hospital management gurus could address these computer problems BEFORE turning them loose on patients? 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"... Then they started resigning their appointments: <blockquote class="tr_bq">Athens Regional addressing new computer system problems encountered by doctors By Donnie Z. Fetter Friday, May 23, 2014 <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> Doctors affiliated with Athens Regional Medical Center (<a href="http://www.athenshealth.org/">http://www.athenshealth.org/</a>) have expressed concerns that a computer system installed this month at the hospital endangers patients.</blockquote> Not "may endanger patients."  "Endangers patients."  That's quite direct. <blockquote class="tr_bq">However, the hospital's chief executive said Athens Regional is taking "swift action" to address those concerns.</blockquote> I'm not impressed.  The executives should perhaps have done due diligence and taken action BEFORE this bad health IT was set loose on live, unsuspecting patients. 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. <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 “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.”</blockquote> 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...   <blockquote class="tr_bq">The letter was addressed to ARMC President and CEO James G. Thaw and Senior Vice President and CIO Gretchen Tegethoff. 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. The doctor who provided the letter to the Banner-Herald refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues.</blockquote> Refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues ... 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>.) 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): <blockquote class="tr_bq">University of Georgia Terry College of Business, Executive Program, Finance 2014 – 2014 (expected) The George Washington University - School of Business Master of Science, Information Systems Technology 2001 – 2003 West Virginia University BS, Medical Technology 1993 – 1997 </blockquote> 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): <blockquote class="tr_bq">Technical Analyst STG (9 months) [Provided U.S. Department of State with systems support and application maintenance.] Clinical Systems Analyst George Washington University Hospital (3 years 8 months) Technical Support Specialist/Installer Intellidata, Inc. (9 months) Clinical Research Associate QUINTILES, INC. (9 months) Information Specialist THE EMMES CORPORATION (1 year 8 months) Writer/Editor ASPEN SYSTEMS CORPORATION (7 months) Medical Technologist PROVIDENCE LABORATORY ASSOCIATES (8 months) </blockquote> This background led directly to: <blockquote class="tr_bq">Chief Information Officer George Washington University Hospital (6 years 8 months) </blockquote> and then the current role: <blockquote class="tr_bq">Athens Regional Health System Vice President and Chief Information Officer Athens Regional Health System</blockquote> 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. 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: <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> <div class="western">Faculty</div><div class="western">CHIME Healthcare CIO Boot Camp (8 months) </div></blockquote> 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 "Malpractice Claims Analysis Confirms Risks in EHRs" at <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 "ECRI Deep Dive Study of Health IT harms" at <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 "ECRI Institute's 2014 Top 10 Patient Safety Concerns for Healthcare Organizations" at <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>, "FDA Internal Memo on H-IT risks - for internal use only" (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. <blockquote class="tr_bq">“From the moment our physician leadership expressed concern about the Cerner I.T. conversion process on May 15, we took swift action and significant progress has been made toward resolving the issues raised,” 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> This raises several questions: <ul><li>How about the moments from the time of decision to acquire the technology?  What safety consideration were in effect during that time? </li></ul> <ul><li>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? </li></ul> <ul><li>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?  </li></ul> One wonders if the executives were aware of analytic work on Cerner ED systems such as performed by U. Sydney professor Jon Patrick at "A study of an Enterprise Health information System",  <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. 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. Back to the article: <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> 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. <blockquote class="tr_bq">But doctors noted the new system often proved too cumbersome to be effective at the time the letter was written. “The Cerner implementation has driven some physicians to drop their active staff privileges at ARMC,” noted the letter. “This has placed an additional burden on the hospitalists, who are already overwhelmed. </blockquote> That's just horrendous for safety. Joint Commission, where are you?   <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> Doctors voted with their feet.  Bravo. 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>: <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): (DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.) <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 insurance carriers, 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 requiring 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>"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.] 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. We assume responsibility for any such malpractice. 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 <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>, the IOM report on HIT safety at <a href="http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF" style="font-style: italic;">http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF</a>, and the FDA Internal Memorandum on H-IT Safety Issues at <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>. CMO __________ (date, time) CIO ___________ (date, time) CMIO _________ (date, time) General Counsel ___________ (date, time) etc."</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> 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> More from the article: <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> For financial incentive reasons in part, I'm sure.  Computers, after all, seem to have more rights than patients...or than physicians and nurses. <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> 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. <blockquote class="tr_bq">"Regardless of what system we are using, our focus on patient safety is unwavering, 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> 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. 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 ("Feds Call For Health IT Safety Center", 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. 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. 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>. 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>). -- SS May 27, 2014 Addendum: 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>.  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. -- SS May 27, 2014 Addendum 2: 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. -- SS May 29, 2014 Addendum: 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> 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 take the time to implement new health IT properly, safely and carefully. 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. The following is an example of one state's statute defining criminal negligence: <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 that the failure to perceive it constitutes a gross deviation from the standard of care that a reasonable person would observe in the situation.''</blockquote> I believe other states' statutes are similar. -- SS June 13, 2013 Addendum: 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> Vertabase (<a href="http://www.vertabase.com/">http://www.vertabase.com/</a>) makes project management software. Cerner.vertabase.com/project/document is some sort of password-protected document resource. I find that interesting - perhaps it's for internal communications and they are learning something from me. <table border="0" cellpadding="1" cellspacing="1" style="width: 450px;"><tbody><tr bgcolor="#F5F5E2"><td align="right" width="150">Domain Name</td><td align="center" width="10"></td><td width="290"> (Unknown) </td></tr><tr><td align="right" valign="top">IP Address</td><td align="center"></td><td>159.140.254.# (Cerner Corporation)</td></tr><tr bgcolor="#F5F5E2"><td align="right">ISP</td><td align="center"></td><td>Cerner Corporation</td></tr><tr><td align="right" valign="top">Location</td><td align="center"></td><td><table cellpadding="0" cellspacing="0"><tbody><tr><td>Continent</td><td> : </td><td>North America</td></tr><tr><td valign="top">Country</td><td valign="top"> : </td><td><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></td></tr><tr><td>State</td><td> : </td><td>Kansas</td></tr><tr><td>City</td><td> : </td><td>Kansas City</td></tr><tr><td>Lat/Long</td><td> : </td><td>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></td></tr></tbody></table></td></tr><tr bgcolor="#F5F5E2"><td align="right" valign="top">Language</td><td align="center"></td><td>English (U.S.) en-us</td></tr><tr><td align="right">Operating System</td><td align="center"></td><td>Macintosh MacOSX</td></tr><tr bgcolor="#F5F5E2"><td align="right" valign="top">Browser</td><td align="center"></td><td>Safari 1.3 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</td></tr><tr><td align="right" valign="top">Javascript</td><td align="center"></td><td>version 1.5</td></tr><tr bgcolor="#F5F5E2"><td align="right" valign="top">Monitor</td><td align="center"></td><td><table cellpadding="0" cellspacing="0"><tbody><tr><td>Resolution</td><td> : </td><td>1440 x 900</td></tr><tr><td>Color Depth</td><td> : </td><td>24 bits </td></tr></tbody></table></td></tr><tr><td align="right">Time of Visit</td><td align="center"></td><td>Jun 13 2014 11:47:42 am</td></tr><tr bgcolor="#F5F5E2"><td align="right">Last Page View</td><td align="center"></td><td>Jun 13 2014 11:47:42 am</td></tr><tr><td align="right">Visit Length</td><td align="center"></td><td>0 seconds</td></tr><tr bgcolor="#F5F5E2"><td align="right">Page Views</td><td align="center"></td><td>1</td></tr><tr><td align="right" valign="top">Referring URL</td><td align="center"> </td><td><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/project/document/index.cfm?&0.12455576848</a></td></tr><tr bgcolor="#F5F5E2"><td align="right">Visit Entry Page</td><td align="center"></td><td><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/2014/05/i-could-not-make-this-up-if-i-tried.html</a></td></tr><tr><td align="right">Visit Exit Page</td><td align="center"></td><td><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/2014/05/i-could-not-make-this-up-if-i-tried.html</a></td></tr><tr bgcolor="#F5F5E2"><td align="right">Out Click</td><td align="center"></td><td></td></tr><tr><td align="right" valign="top">Time Zone</td><td align="center"></td><td><a href="http://www.sitemeter.com/?a=stats&&s=s20hcrenewal&v=100&vlr=14&pg=21&r=31" target="_blank">UTC-6:00</a></td></tr><tr bgcolor="#F5F5E2"><td align="right" valign="top">Visitor's Time</td><td align="center"></td><td>Jun 13 2014 10:47:42 am</td></tr><tr><td align="right">Visit Number</td><td align="center"></td><td align="left">1,342,222</td></tr></tbody></table>  -- SS 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 hospital management gurus could address these computer proble…

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26 May 2014

Patient Safety & Quality Healthcare: "Malpractice Claims Analysis Confirms Risks in EHRs"

Two "EHR beneficence is not exactly as advertised" stories in one day.  It's hard to keep up: After my earlier post today <a href="http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html">"EHRs: The Real Story" - Sobering assessment from Medical Economics</a>, now there's this. From the journal "Patient Safety & Quality Healthcare" (<a href="http://www.psqh.com/%E2%80%8E">PSQH</a>): Malpractice Claims Analysis Confirms Risks in EHRs Jan/Feb 2014 Article available at <a href="http://www.cci.drexel.edu/faculty/ssilverstein/PSQH_MalpractClaimsAnalyConfirRisksEHR.pdf">this link</a>. <blockquote class="tr_bq">[Short header on several EHR-related care foul ups] ... Distressing situations like those described above are happening around the country as healthcare organizations adopt electronic health records (EHRs) in growing numbers. Although these systems promise to reduce costs and improve quality and safety, they’ve also ushered in unintended consequences as a result of human error, design flaws, and technology glitches. Recognizing these emerging risks, CRICO—the patient safety and medical malpractice insurer for the Harvard medical community— is taking action. The Massachusetts-based company has expanded its proprietary coding system to capture EHR-related problems that have contributed to patient harm, and to guide the hospitals, physicians, and other providers it serves toward addressing vulnerabilities in their systems. </blockquote> I had previously written about another Med Mal insurer who had noted these problems at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal">http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal</a>. <blockquote class="tr_bq">... CRICO recently analyzed a year’s worth of medical malpractice claims in its comparative database and found 147 cases in which EHRs were a contributing factor. Computer systems that don’t “talk” to each other, test results that aren’t routed properly, and mistakes caused by faulty data entry or copying and pasting were among the EHR-related problems found in the claims, which represented $61 million in direct payments and legal expenses.</blockquote> The article notes this: <blockquote class="tr_bq"> ... Half of the 147 cases resulted in severe injury.</blockquote> Patient deaths were a likely result, too, I note. Note that this is just one insurer's data and assuming a good number of them were local to Massachusetts, could represent a significant percentage of the annual medical malpractice lawsuits in the state (Pennsylvania, a much larger state, has about 1500 med mal lawsuits filed annually).  Note also that most cases of harm never make it to litigation due to the harsh economics of medical malpractice. Numbers such as this will be going up as implementation, driven by HITECH incentives and penalties, accelerates in coming years.  This is especially true as medical centers and physician practices with far less clinical IT expertise and savvy than Harvard's become HIT users, and as the ability to capture such events increases. The ECRI Institute "Deep Dive" study of health IT risk also speaks to a rise in numbers, with its finding of 171 health IT "events" in just 36 hospitals over 9 weeks voluntarily reported (i.e., just a fraction of the total), with 8 injuries and 3 possible deaths as a result (<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>). <blockquote class="tr_bq">... The team asked its CRICO and Strategies members, “What vulnerabilities are you seeing? What are your risk managers worried about? What are your doctors complaining about?” It used that feedback to draft a set of EHR-specific codes and then tested them in three datasets: CRICO (Harvard users) and two of Strategies’ larger clients, !e Doctors Company and Princeton Insurance. Based on those results, CRICO revised and approved 15 new EHR codes that went “live” in January 2013. That means CRICO’s cadre of nurse coders can now identify EHR as a contributing factor to a malpractice claim, instead of using one of the less specific factors available in the past. [It's about time for a dose of transparency in the health IT sector - ed.]  And they can flag whether the problem involved user issues, system/technology issues, or both. “In some cases,” Sato points out, “the system design sets up humans to make errors.” </blockquote> This should all be no surprise to any reader of this blog.  Read the whole article. A more comprehensive list of "EHR harm modes" are at my posts "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide" (<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 "Cart Before the Horse, Part 3: AHRQ's Health IT Hazard Manager" (<a href="http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html">http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html</a>). The actual Hazards Manager report is at <a href="https://www.blogger.com/null"></a><a href="http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf">http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf</a>. It contains this summary of known hazards: <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/AVvXsEjBfqMe89ZhrHPmZk_4tCcymGkvz0t0XEm8VSOMumbHa-U2WrdKJeZaZDUb8iQMEr5Y2ZwleIsSrYDanYk9nGbP9UOERnVYtIDNu0dhTodoua_1sfR6nHyVk_98F0eyq2xOjnBa_bjUejjX/s1600/hazman.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="247" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjBfqMe89ZhrHPmZk_4tCcymGkvz0t0XEm8VSOMumbHa-U2WrdKJeZaZDUb8iQMEr5Y2ZwleIsSrYDanYk9nGbP9UOERnVYtIDNu0dhTodoua_1sfR6nHyVk_98F0eyq2xOjnBa_bjUejjX/s1600/hazman.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">AHRQ's taxonomy of health IT hazards.  Click to enlarge.</td></tr></tbody></table> ------------------- Having written on these issues since 1998 as a "health IT iconoclast" (<a href="http://rtg.cis.upenn.edu/MDCPS/Posters/IT%20Iconoclasts.pdf">http://rtg.cis.upenn.edu/MDCPS/Posters/IT%20Iconoclasts.pdf</a>) and having been largely ignored by the cognoscenti, can I now say "I told you so?" -- SS

Patient Safety & Quality Healthcare: "Malpractice Claims Analysis Confirms Risks in EHRs"

Two "EHR beneficence is not exactly as advertised" stories in one day. It's hard to keep up:After my earlier post today "EHRs: The Real Story" - Sobering assessment from Medical Economics, now there'…

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28 Feb 2014

A Day In The Life Of A (Reluctant But Coerced) EHR-Using Physician - And Her Patients

A reader, a physician who wishes to be unnamed due to fear of retaliation, writes the following: <blockquote class="tr_bq">Dear Dr. Silverstein, As you write, there is not a transaction of medical care that does not go through EHR systems. However, these poorly usable EHR systems stifle creative and artistic thought required to link risk, benefit, and probability of diagnosis with risks and benefits of testing and therapeutics. Assuring safety and efficacy with pre- and  aftermarket surveillance will maximize the possibility of achieving the potential of the technologies. Additionally, when I use these electronic ordering systems and  libraries of medical information, they fail to keep up with the agility and nimbleness of my mind as I seek 'random access' to pieces of data to formulate and synthesize diagnoses and therapeutic strategies. The EHRs are too slow, do not have a robust (if any) search function, randomly and whimsically store key information with ever changing formats, and generally obfuscate what should be simple. They are cumbersome and disable the ability to simultaneously and contemporaneously compare myriad data points. They get an "F" as enablers of complex diagnostics. Paper, since it can be organized as needed and set out on a desk to be seen and compared as quickly as the eye registers the data, gets an "A". The EHRs  are impediments and disrupters of communication. Example: Just today, I was witness to the fact that a stat EKG was ordered by CPOE  on a heart patient yesterday at or shortly after 4:30 pm. The intended recipient of the order (heart station) never got it because they close near 4:30 pm and there was no warning to the ordering health professional that was so. Thus, the EKG was never done, and this morning, when the requisition was seen, no one did it because it was ordered stat "yesterday", and the techs asked themselves "what good would it do for a 'stat' to be done now, a day late?" I do not know what happened to the patient.  I have many other examples of such delays facilitated by the CPOE and EHR systems that I am required to use at numerous facilities. They facilitate 'stealth' alterations in care.  Also just today, a disease-critical test ordered 3 days ago was not done because it was cancelled in 'stealth' (automatically "expired") without warning to me by the lab responsible for doing it. There is the "silent silo" syndrome as you've called it.  Also just today, a disease critical test ordered 5 days ago came back with results, but the results were posted in the information 'silo' of 5 days ago. The lab screen default on the EHR only goes back 4 days (so unless I knew to look for it, it would not be seen or acted on), further obfuscating data and delaying treatment. The EHRs lose data and orders.  Also just today, I found that blood coagulation monitoring tests that were ordered to be done with kidney dialysis (3 days per week) on a patient somehow got "lost" and were not being done for 5 days, putting my patient at risk of bleeds - or stroke if the blood was not 'thin' enough. I just walked in to examine a hospitalized patient with multi-organ failure and diabetes, on multiple meds including insulin, and recovering from respiratory failure. The nurse anxiously informed me that the blood sugar was dangerously low. I ordered treatment stat. I see patients in the morning before labs come back, and depend on nurses to review labs and notify me. Turns out that the patient was hypoglycemic on yesterday morning labs that arrived in the EHR 'silo' after I left the hospital; and was also low in potassium, but the tests just laid there comfortable in their silos; and were not communicated to anyone like in the old days when a human ward clerk or other undistracted human received them and disseminated them to the appropriate professionals. Thus, instead of getting less insulin, the patient got the usual dose with near catastrophic adversity. Misidentifications are facilitated by EHRs.  I  noticed that on several critical clinically significant changes that arose on my patient that were entered as such in an EHR silo by the RN, it was stated that they called attending physician 'Dr X', which was not me...obviously a case of EHR-facilitated misidentification. Here is a misidentification variant:  yesterday, someone (non doctor but not clear who) ordered a specialist consultation on one of my patients under my name. I did not order it nor was it needed, yet it showed up as an order for me to sign. Like you, I agree this is representative of a toxic impact of these systems on medical care and I feel like the care environment is foul, like a cesspool, compared to what has been replaced. These systems of medical devices cannot be trusted in the care of sick patients. Perhaps, they are OK for managing hang nails.</blockquote> I offer no additional comments other then if I am sick, I do not want my care interfered with in this manner by IT. Rest assured, though - there are IT hyper-enthusiasts out there (<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>) who would see little problem with this, as any accidents that occur are "anecdotes", "learning experiences" or "bumps in the road." That's if they don't simply blame the user. -- SS

A Day In The Life Of A (Reluctant But Coerced) EHR-Using Physician - And Her Patients

A reader, a physician who wishes to be unnamed due to fear of retaliation, writes the following:Dear Dr. Silverstein,As you write, there is not a transaction of medical care that does not go through E…

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09 Feb 2014

Quality and Safety Implications of Emergency Department Information Systems: ED EHR Systems Pose Serious Concerns, Report Says

A report "Quality and Safety Implications of Emergency Department Information Systems" appeared in the Oct. 2013 issue of "Annals of Emergency Medicine."  It is available fulltext at <a href="http://www.annemergmed.com/article/S0196-0644%2813%2900506-4/fulltext">http://www.annemergmed.com/article/S0196-0644%2813%2900506-4/fulltext</a>, or in PDF via the tab, free as of this writing. First, a preamble:  I once tried to alert a hospital where I'd trained decades before, Abington Memorial Hospital (<a href="http://www.amh.org/">http://www.amh.org/</a>), of impediments to safe care I'd noted in their EHR's, predominantly their ED EHR.  They did not listen.  In fact, their response to my concerns was characterized by an apparent incompetence regarding conduct of safety investigations.  For instance, to my written concern in an April 2010 letter to the CEO and CMO about the ED EHR that: <blockquote class="tr_bq"> ... I've also had to stop administration [to my mother] of an antibiotic (Levaquin) in the recent past in the ED that she has had an adverse reaction to (torn rotator cuff), despite my having told ED intake she was allergic to it. She relates that administration of Levaquin was then almost repeated on the floor until she herself refused it during that past admission.</blockquote> This was the sworn testimony in May 2013 about the "investigation" that resulted, from the hospital's VP of Risk Management, <a href="http://www.corporationwiki.com/Pennsylvania/Abington/regina-sturgis/81813980.aspx">Regina Sturgis</a>: <blockquote class="tr_bq">A:      Deborah [hospital General Counsel] asked me to investigate the Levaquin issue which I did. Q:      Did you do that on your own or did you delegate some of the -- A:      No.  I did it on my own. Q:      Do you know whether any of the IT folks were ever brought in to look at the -- the EMR issues referenced in this letter? A:     No, I do not.  I know that I was asked to look at the Levaquin because of my clinical background. Q:      Okay.  Did you come up with any conclusions? A:      Yes. Q:      What was your conclusion? A:      That she had been ordered Levaquin in the ETC [Emergency Trauma Center a.k.a. ED], that it had been discontinued about a very short period of time later, under a half an hour, and that she never received it. </blockquote> So, the investigation of a complaint that family and then the patient themselves had to stop the administration of a drug whose staff and EHR had been informed of an allergy consisted of confirming that the medication was never given.  No problem, the ED EHR is safe. (I am not joking; that is the testimony given.  Imagine such an investigation and conclusion about, say, reported aircraft flaws, or, in the industry in which I was once a safety officer, public transit vehicle defects and dangers.) However, when competent people investigate similar issues, the findings are concerning.  From Modern Healthcare (<a href="http://www.modernhealthcare.com/">http://www.modernhealthcare.com/</a>), a publication for healthcare executives, on the new Annals of Emergency Medicine article: <blockquote class="tr_bq"><a href="http://www.modernhealthcare.com/article/20130624/NEWS/306249952/">ED EHR systems pose serious concerns, report says</a> By <a href="mailto:jconn@modernhealthcare.com" target="_blank">Joseph Conn</a> Modern Healthcare <div>June 24, 2013</div></blockquote><blockquote>Electronic health-record systems used in <a href="http://www.modernhealthcare.com/section/articles?tagID=5739" target="_blank">emergency</a> departments are beset with poor data displays, loaded with so many alerts warning of potential <a href="http://www.modernhealthcare.com/section/articles?tagID=51" target="_blank">patient-safety issues</a> that they can lead to user alert fatigue, and may be generating incorrect physician orders, according to a report by two emergency physicians' study groups. Meanwhile, providers wanting to address these <a href="http://www.modernhealthcare.com/section/articles?tagID=975" target="_blank">EHR</a> issues are hampered by a lack of research and solid evidence of the extent of the problem with these systems, and by contract provisions with EHR vendors that stymie the free flow of information about system-linked safety concerns, the report authors say. </blockquote> So, ED's across the country are rolling out technology, often taking advantage of ARRA's HITECH incentives ... but there is a lack of research and solid evidence into the risks.  Allow me to opine - that's simply crazy. <blockquote class="tr_bq">The groups found that “poor data display is a serious problem with many of today's EDISs,” while “the sheer volume” of alerts that range from the “completely irrelevant to life threatening” [or lack of appropriate alerts to relevant, simple issues such as data input errors - ed.] can “dull the senses, leading to a failure to react to a truly important warning.” They also found that “an alarming number of clinicians are anecdotally reporting a substantial increase in the incidence of wrong order/wrong patient errors while using the computerized physician order entry component of information systems.”</blockquote> The word "anecdote", as I have written, is being misused.  The reports are not "anecdotes."  They are risk management-relevant incident reports.  (See "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" at <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html</a>.) <blockquote class="tr_bq">Two study groups from the American College of Emergency Physicians have recommended a program of systemic vigilance over electronic health-record systems used in emergency departments to improve patient safety and enhance quality of care. ACEP workgroups on informatics and on quality improvement and patient safety published their findings in an article, “<a href="http://www.annemergmed.com/article/S0196-0644%2813%2900506-4/abstract" target="_blank">Quality and Safety Implications of Emergency Department Information Systems</a>,” in the current issue of the Annals of Emergency Medicine. </blockquote> Post marketing surveillance, a standard for decades in other healthcare sectors, has been absent from health IT due to a long-obsolete special regulatory accommodation afforded that industry.  This accommodation was initiated when systems were simple and merely advisory - not the comprehensive enterprise clinical resource and clinician command-and-control systems they are today.  Now, clinician investigators of the technology such as the authors of this study are realizing that continuing this accommodation is a mistake. <blockquote class="tr_bq">It follows in the wake of, and references, an Institute of Medicine report from 2011, “Health IT and Patient Safety: Building Safer Systems for Better Care.” That report concluded that “current market forces are not adequately addressing the potential risks associated with the use of health IT.” It also comes eight months after the New England Journal of Medicine published “<a href="http://www.nejm.org/doi/full/10.1056/NEJMsb1205420" target="_blank">Electronic Health Records and National Patient-Safety Goals</a>,” which warned that recent evidence “has highlighted substantial and often unexpected risks resulting from the use of EHRs and other forms of health information technology.”</blockquote> I note that if you frequent this blog, you likely read material similar to the bolded red statements above here first, as authored by me, dating to the founding of this blog in 2004. <blockquote class="tr_bq">... “The rush to capitalize on the huge federal investment of $30 billion for the adoption of electronic medical records led to some unfortunate and unintended consequences, particularly in the unique emergency department environment,” said Dr. Heather L. Farley, the lead author of the report, in a news release. “The irreversible drive toward EDIS implementation should be accompanied by a constant focus on improvement and hazard prevention." Farley is assistant chairwoman of the Department of Emergency Medicine at Christiana Care Health System in Newark, Del.</blockquote> Ironically, I note in Dr. Farley's statement some of my own advice, given to ED staff when I was Chief Medical Informatics Officer at Christiana Care 1996-8.   I had in that time period advised <a href="http://www.christianacare.org/bodymod.cfm?id=169&action=detail&ref=1909">Charles Reese IV, MD</a>, Chair of Emergency Medicine, to not implement EHRs or, at best, implement document imaging systems (since ED charts are not that long or complex), not full field-based EHRs, due to the "unfortunate and unintended consequences" of bad health IT in such an environment I recognized even then.  It was only a few years ago that my advice was finally overturned. <blockquote class="tr_bq">The authors also report “(t)here are few consistent data on how commonly these errors occur, and few studies are actually focused on collecting evidence of these errors.” Meanwhile, “there is currently no mechanism in place to systematically allow, let alone encourage, users to provide feedback about ongoing safety issues or concerns” with EHRs in general, and EDISs specifically.</blockquote> On its face, that is not a safety-conscious environment and the rollout and use of such systems seems a fundamental violation of patient's rights, made worse by the fact that there is no informed consent process whatsoever to ED EHR use. <blockquote class="tr_bq">The workgroups came up with seven recommendations: appointing an emergency department “clinician champion,” creating within healthcare delivery organizations an EDIS performance improvement group and an ongoing review process, paying timely attention to EDIS-related patient-safety issues raised by the review process, disseminating to the public lessons learned from performance improvement efforts, distributing vendors' product updates in a timely manner to all EDIS users and removing the “hold harmless” and “learned intermediary clauses” from vendor contracts. </blockquote> Many of these issues have been discussed on this blog. <blockquote class="tr_bq">“The learned intermediary doctrine implies that the end users (clinicians) are the medical experts and should be able to detect and overcome any fallibility or contributing factor of the product,” the authors said.</blockquote> I have also pointed out the absurdity of such a "doctors are clairvoyant" attitude, e.g., at my 2011 post on basic common sense on IT adverse consequences at <a href="http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html">http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html</a>. <blockquote class="tr_bq">They conclude that the “lack of accountability for vendors through hold harmless clauses and the shifting of liability to the clinicians through the learned intermediary doctrine are significant and additional impairments to safety improvement. Electronic health records and EDISs are sufficiently complex that the physician and other users cannot be expected to anticipate unpredictable errors.” </blockquote> That aligns with the work of Dr. Jon Patrick in Sydney, whose treatise "A study of an Enterprise Health information System" on the Cerner FirstNet ED EHR is available here: <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> <blockquote class="tr_bq">Earlier this month, the Electronic Health Record Association, an EHR developers trade group affiliated with the Chicago-based Healthcare Information and Management Systems Society, announced the launch of a voluntary “<a href="http://www.modernhealthcare.com/article/20130611/NEWS/306119952/ehr-trade-group-issues-code-of-conduct-to-improve-patient-safety" target="_blank">code of conduct</a>” in which adherents would agree to drop “gag clauses” in the contracts with their provider customers. </blockquote> Great.  Per the wonderful 2007 article "The Denialists' Deck of Cards: An Illustrated Taxonomy of Rhetoric Used to Frustrate Consumer Protection Efforts" by Chris Jay Hoofnagle, available at <a href="http://papers.ssrn.com/sol3/papers.cfm?abstract_id=962462">http://papers.ssrn.com/sol3/papers.cfm?abstract_id=962462</a>, as of this writing free: <blockquote class="tr_bq"> ... At this point [of losing the argument], the denialist must propose "self regulation" to deal with the problem that doesn't exist. The cool thing about self regulation is that it cannot be enforced, and once the non-existent problem blows over, the denialist can simply scrap it! [20] [20] In the runup to passage of bank privacy legislation, data brokers created a group called the "Individual Reference Services Group" that promptly disappeared after the legislation passed.</blockquote> ("Denialism" is the use of rhetorical techniques and predictable tactics to erect barriers to debate and consideration of any type of reform, regardless of the facts.) IMO 'self regulation' of healthcare is, on its face, a deception.  There are simply too many conflicts of interest. On use of "integrated" big systems: <blockquote class="tr_bq">“These systems do have glitches [indeed - see <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> - ed], but it can be plain and simple bad design that can lead to clinical errors,” Cozzens said.  But ED physicians, he said, are “having the enterprise systems forced upon them. To think you can take one system and adapt it to those different environments is totally wrong. That's why you see low physician satisfaction and the productivity is going down, all for the sacrifice of having an integrated system.”</blockquote> In fact, so-called "best of breed" systems can be bad health IT as well.  See the aforementioned evaluation by Dr. Patrick in Australia. <blockquote class="tr_bq">Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, hard to customize, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  </blockquote> Through my own work, I've seen bad health IT result in patient harm and death.  It's just unfortunate that I got started in this line of work by being, in effect, shot out of a cannon.  That is, my own mother was a victim. -- SS Addendum 10/8/13: From the article: <blockquote class="tr_bq">End-User Recommendation 4: EDIS-related patient safety concerns identified by the review process should be addressed in a timely manner by ED providers, the EDIS vendors, and hospital administration. Each of these processes should be performed in full transparency, specifically with openness, communication, and accountability. </blockquote> I'm not sure the aforementioned levaquin near-accident "investigation" meets these standards. -- SS

Quality and Safety Implications of Emergency Department Information Systems: ED EHR Systems Pose Serious Concerns, Report Says

A report "Quality and Safety Implications of Emergency Department Information Systems"appeared in the Oct. 2013 issue of "Annals of Emergency Medicine." It is available fulltext at http://www.annemer…

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08 Oct 2013

American Medical Association finally on board with EHR views expressed on this blog since 2004

<div style="text-align: center;">- Posted on the Healthcare Renewal Blog May 17, 2013 -</div> It seems to have taken awhile, but organized medicine seems to finally be recognizing that today's commercial health IT is not quite the revolutionizing, transformative, plug-and-play panacea to healthcare's ills it is often touted as: <blockquote class="tr_bq">AMA Wire May 15, 2013 <a href="http://www.ama-assn.org/ams/pub/amawire/2013-may-15/2013-may-15-general_news1.shtml">AMA board chair: HHS should address EHR usability issues immediately</a> The government needs to act quickly to remedy the impaired usability of electronic health records (EHR) if the technology's touted benefits are to be realized, AMA Board of Trustees Chair Steven J. Stack, MD (left), told officials during a federal hearing last week. "The AMA and most physicians believe that, done well, EHRs have the potential to improve patient care," Dr. Stack, an emergency physician in Lexington, Ky., said during his 30-minute <a class="pdf" href="http://www.ama-assn.org/resources/doc/washington/ehr-meaningful-use-testimony-03may2013.pdf" target="_blank">testimony</a>. "At present, however, these EHRs present substantial challenges to the physicians and other clinicians now required to use them." He emphasized that many of today's EHR systems require significant changes before they can deliver the promised outcomes. Referring to Medicare's meaningful use program, he pointed to undesired consequences of pushing EHR systems on physicians before the technology was completely ready for prime time.</blockquote> "Immediately" is strong language. I note that the phrase "health IT done well" is a term I've been using since 1998 at my now-Drexel-based health IT teaching website at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases">http://www.ischool.drexel.edu/faculty/ssilverstein/cases</a>, as well as at this blog. Penned by me at my aforementioned Drexel graduate teaching site, originally housed on AOL, in 1998 and still appearing in its main essay: <blockquote class="tr_bq"><div class="MsoNormal">... While clinical IT is now potentially capable of achieving many of the benefits long claimed for it such as improved medical quality and efficiency, reduced costs, better medical research and drugs, earlier disease detection, and so forth, there is a major caveat and essential precondition:  the benefits will be realized only if clinical IT is done well.  For if clinical IT is not done well, as often occurs in today’s environment of medical quick fixes and seemingly unquestioning exuberance about IT, the technology can be injurious to medical practice and biomedical R&D, and highly wasteful of scarce healthcare capital and resources.  </div><div class="MsoNormal"> </div>Those two short words “done well” mask an underlying, profound, and, as yet, largely unrecognized (or ignored) complexity.  This website is about the meaning of "done well" in the context of clinical computing, a computing subspecialty with issues and required expertise quite distinct from traditional MIS (management information systems, or business-related) computing.</blockquote> (I have more recently switched to the easier-to-parse terminology of "good health IT" vs. "bad health IT" after discussions with Dr Jon Patrick at U. Sydney during my visit Down Under last summer, <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html">http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html</a>.) I've also heard "not ready for prime time" before.  It is a phrase I used in speaking with a New York Times reporter that then appeared in the Oct. 8, 2012 NYT article "The Ups and Downs of Electronic Medical Records" (<a href="http://www.nytimes.com/2012/10/09/health/the-ups-and-downs-of-electronic-medical-records-the-digital-doctor.html?pagewanted=2">http://www.nytimes.com/2012/10/09/health/the-ups-and-downs-of-electronic-medical-records-the-digital-doctor.html?pagewanted=2</a>) by Milt Freudenheim, October 8, 2012, where I am quoted and this blog cited: <blockquote class="tr_bq">... Critics are deeply skeptical that electronic records are ready for prime time. “The technology is being pushed, with no good scientific basis,” said Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>. He says testing these systems on patients without their consent “raises ethical questions.” </blockquote> The AMA Board chair went on to opine: <blockquote class="tr_bq">"Attempting to transform the entire health system in such a rapid and proscriptive manner has compelled providers to purchase tools not yet optimized to the end-user's needs and that often impeded, rather than enable, efficient clinical care," he said. He noted that physicians are "prolific technology adopters" but that adoption of EHR systems has required federal incentives because the technology still is "at an immature stage of development."</blockquote> My near-exact terminology has been that the technology is still experimental. <blockquote class="tr_bq">"EHRs have been and largely remain clunky, confusing and complex," he said.</blockquote> Perhaps he read my ten-part series on the health IT mission hostile user experience at this blog, at <a href="http://www.tinyurl.com/hostileuserexper">http://www.tinyurl.com/hostileuserexper</a>. <blockquote class="tr_bq">According to a <a class="external" href="http://www.americanehr.com/blog/2013/03/himss13-ehr-satisfaction-diminishing/" target="_blank">recent survey</a> by AmericanEHR Partners, physician dissatisfaction with EHR systems has increased. Nearly one-third of those surveyed in 2012 said they were "very dissatisfied" with their system, and 39 percent said they would not recommend their EHR system to a colleague—up from 24 percent in 2010.</blockquote> A survey I posted about in Jan. 2010 is here:  "An Honest Physician Survey on EHR's", <a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html</a> <blockquote class="tr_bq">Dr. Stack spoke at a "listening session" hosted by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), a division of the U.S. Department of Health and Human Services (HHS). The agencies coordinated the session to examine how a marked increase in code levels billed for some Medicare services might be tied to the increased use of EHRs. Dr. Stack noted that some Medicare carriers have begun denying payment for charts that are too similar to other records. "In this instance, even when clinicians are appropriately using the EHR, a tool with which they are frustrated and the use of which the federal government has mandated under threat of financial penalty, they are now being accused of inappropriate behavior, being economically penalized, and being instructed ‘de facto' to re‐engineer non‐value‐added variation into their clinical notes," he said. "This is an appalling Catch‐22 for physicians."</blockquote> "Mandated under threat of financial penalty" has been one of my stated "cart before the horse" issues with HITECH (e.g., <a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html</a>). <blockquote class="tr_bq">Dr. Stack advised officials that three key actions are necessary to rectify these issues with EHR systems: <ul type="disc"><li>The ONC promptly should address EHR usability concerns raised by physicians and add usability criteria to the EHR certification process.</li><li>CMS should provide clear and direct guidance to physicians concerning use of EHRs for documentation, coding and billing. </li><li>Stage 2 of the meaningful use program should allow more flexibility for physicians to meet requirements as EHR systems are improved. </li></ul>The AMA will continue to work with federal agencies to improve EHR systems and the Medicare meaningful use program.</blockquote> I've been calling for usability evaluation to be added to the certification process, including in comments during public comment periods to HHS, for some time. What the AMA Board Chair is apparently missing, though, is health IT safety.  They should perhaps read my post on the recent ECRI Institute Deep Dive Study on health IT risk - itself based on a report in their own AMNews (<a href="http://amednews.com/" target="_blank">amednews.com)</a> publication ("Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events", <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>). I don't think any prudent person would consider a 9-week study of 36 hospitals with volunteered reports of 171 health information technology-related problems, where eight of the incidents reported involved patient harm and three may have contributed to patient deaths, information to ignore. -- SS

American Medical Association finally on board with EHR views expressed on this blog since 2004

- Posted on the Healthcare Renewal Blog May 17, 2013 -It seems to have taken awhile, but organized medicine seems to finally be recognizing that today's commercial health IT is not quite the revolutio…

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17 May 2013

New York Times: "In Second Look, Few Savings From Digital Health Records", and AMA Med News on EHR Harms

This post should perhaps be entitled "I told you so." A letter I wrote in response to the Wall Street Journal's "<a class="" href="http://online.wsj.com/article/SB123431432273870909.html">A Health-Tech Monopoly</a>", Feb. 11, 2009 was <a href="http://online.wsj.com/article/SB123492035330205101.html">published</a> Feb. 18, 2009 under the header Digitizing Medical Records May Help, but It's Complex. I wrote: <blockquote class="tr_bq">Dear Wall Street Journal, You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill. I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants. For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors. HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine. The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker. I can only hope patients get something worthwhile for the $20 billion. Scot Silverstein, M.D. Faculty, Biomedical Informatics Drexel University Institute for Healthcare Informatics Philadelphia</blockquote> I also had penned essays on the need for a moratorium on HITECH (Nov. 2008, "<a href="http://hcrenewal.blogspot.com/2008/11/should-us-call-moratorium-on-ambitious.html" target="_blank">Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?</a>" and Jan. 2009, "<a href="http://hcrenewal.blogspot.com/2009/01/i-ask-again-should-us-call-moratorium.html" target="_blank">I Ask Again: Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?</a>").  My theme was that the issues with implementation of good health IT and elimination of bad health IT, and the issue of how to implement most efficiently, needed to be better understood before a national rollout.  Hold off multi-billion dollar national initiatives "until we know how to get HIT right", I wrote. Now the New York Times has this, citing a new RAND paper: <blockquote class="tr_bq"><a href="http://www.nytimes.com/2013/01/11/business/electronic-records-systems-have-not-reduced-health-costs-report-says.html" target="_blank">In Second Look, Few Savings From Digital Health Records</a> By REED ABELSON and JULIE CRESWELL January 10, 2013 The conversion to electronic health records has failed so far to produce the hoped-for savings in health care costs and has had mixed results, at best, in improving efficiency and patient care, according to a new analysis by the influential RAND Corporation. Optimistic predictions by RAND in 2005 helped drive explosive growth in the electronic records industry and encouraged the federal government to give billions of dollars in financial incentives to hospitals and doctors that put the systems in place. “We’ve not achieved the productivity and quality benefits that are unquestionably ["unquestionably?" why?- ed.]  there for the taking,” said Dr. Arthur L. Kellermann, one of the authors of a reassessment by RAND that was published in this month’s edition of Health Affairs, an academic journal.</blockquote> Noted is the provenance of the 2005 report that created the windfall for the electronic records industry: <blockquote class="tr_bq">RAND’s 2005 report was paid for by a group of companies, including General Electric and Cerner Corporation, that have profited by developing and selling electronic records systems to hospitals and physician practices. Cerner’s revenue has nearly tripled since the report was released, to a projected $3 billion in 2013, from $1 billion in 2005.</blockquote> A retraction: <blockquote class="tr_bq">The report predicted that widespread use of electronic records could save the United States health care system at least $81 billion a year, a figure RAND now says was overstated. The study was widely praised within the technology industry and helped persuade Congress and the Obama administration to authorize billions of dollars in federal stimulus money in 2009 to help hospitals and doctors pay for the installation of electronic records systems ... But evidence of significant savings is scant, and there is increasing concern that electronic records have actually added to costs by making it easier to bill more for some services.</blockquote> In my Feb. 2009 WSJ letter, I'd written that "it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants."  It appears I was correct. <blockquote class="tr_bq"> Officials at RAND said their new analysis did not try to put a dollar figure on how much electronic record-keeping had helped or hurt efforts to reduce costs. But the firm’s acknowledgment that its earlier analysis was overly optimistic adds to a chorus of concern about the cost of the new systems and the haste with which they have been adopted.</blockquote> Not mentioned are harms that bad health IT is creating. <blockquote class="tr_bq">The recent analysis was sharply critical of the commercial systems now in place, many of which are hard to use and do not allow doctors and patients to share medical information across systems. “We could be getting much more if we could take the time to do a little more planning and to set more standards,” said Marc Probst, chief information officer for Intermountain Healthcare, a large health system in Salt Lake City that developed its own electronic records system </blockquote> A "little more" planning?  How about several years' worth, to ensure the technologies are safe, effective and properly vetted, along with a system for post-market surveillance as exists in other healthcare sectors? <blockquote class="tr_bq">Technology “is only a tool,” said Dr. David Blumenthal, who helped oversee the federal push for the adoption of electronic records under President Obama and is now president of the Commonwealth Fund, a nonprofit health group. “Like any tool, it can be used well or poorly.” While there is strong evidence that electronic records can contribute to better care and more efficiency, Dr. Blumenthal said, the systems in place do not always work in ways that help achieve those benefits.</blockquote> Dr. Blumenthal seems to be triangulating from his <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html" target="_blank">earlier 2010 NEJM statement that</a>: <blockquote class="tr_bq">... The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.</blockquote> Meantime, in the real world signs of my expressed concerns about a quagmire are appearing: <blockquote class="tr_bq">... Late last year, a physician practice in Panama City, Fla., filed a lawsuit against the health care technology firm Allscripts after the company stopped supporting an electronic records system called MyWay that it had sold to 5,000 small-group physicians at a cost of $40,000 per physician. The lawsuit said that the system had problems and that the physician group was unable to meet the criteria for federal incentive money. A spokeswoman for Allscripts said it would defend itself vigorously.</blockquote> A clue as to the candidness of the new report: <blockquote class="tr_bq">... The new analysis was not sponsored by any corporations, said Dr. Kellermann, who added that some members of RAND’s health advisory board wanted to revisit the earlier analysis.</blockquote> Finally, this from the horse's mouth: <blockquote class="tr_bq">Dr. David J. Brailer, who was the nation’s first health information czar under President George W. Bush, said he still believed tens of billions of dollars could eventually be squeezed out of the health care system through the use of electronic records. In his view, the “colossal strategic error” that occurred was a result of the Obama administration’s incentive program.</blockquote> I repeat my admonition from 2009 that I can only hope patients get something worthwhile for the $20 billion, which by now is probably many times that amount. Finally, I note the American Medical News cites me in a <a href="http://www.ama-assn.org/amednews/2013/01/14/prsa0114.htm" target="_blank">Jan. 14, 2013 article</a> as follows: <blockquote class="tr_bq">... Other experts on health IT said the Pennsylvania [PA Patient Safety Authority] study probably underestimates the extent of health IT safety problems. They say that is because the research is based on voluntary reports and that health professionals are unaware that a patient safety incident was caused by an EHR failure. “These systems are incredibly complex,” said Scot M. Silverstein, MD, a consultant in medical informatics at Drexel University in Philadelphia. “They’re not just huge filing cabinets, they are enterprise resource management systems. There are many ways that things can go wrong that may not be seen as the computer having caused the mess-up in the first place.” For example, he said, it would be difficult for a practicing physician to detect when data are missing from a record or that an alert failed to pop up.</blockquote> Yet the title of the article is "<a href="http://www.ama-assn.org/amednews/2013/01/14/prsa0114.htm" target="_blank">EHR-related errors soar, but few harm patients</a>" with a table at the bottom labeled "How rarely EHR problems harm patients." More evidence that EHRs always receive special accommodation.  I was an invited reviewer of the PA Patient Safety Authority report, and wrote about the major deficiencies of its dataset at my posts Dec. 13, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/12/pennsylvania-patient-safety-authority.html" target="_blank">Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events</a>" and a follow-up Dec. 19 post "<a href="http://hcrenewal.blogspot.com/2012/12/a-very-signifcant-additonal-observation.html" target="_blank">A Significant Additional Observation on the PA Patient Safety Authority Report -- Risk</a>." My major point was that one simply cannot know what one cannot know, when using a very incomplete dataset gathered in a setting of systematic impediments to accuracy and completeness.  For instance, as I wrote in those earlier posts, through my work I personally know of cases of harms up to and including death that should have been in the PA database, but apparently are not - and I'm just one person. We simply don't know in 2013 how many EHR errors harm patients, and the effects of increasing adoption by organizations and physicians less technology-able than current adopters.  I hope the magnitude of harms is truly small, but hope is not enough; this study and report was just a 'dipping of the toes into the water' towards understanding the realities. Incidentally, we also don't know how severely the known toxic effects of bad health IT might affect care in times of duress, e.g., an epidemic.  However, I am certainly not sanguine about EHRs in their present state as robustly facilitating national emergency preparedness. My dreaded prediction for the future?  A 2016 AMA News story entitled "Known EHR-related harms soar." -- SS

New York Times: "In Second Look, Few Savings From Digital Health Records", and AMA Med News on EHR Harms

This post should perhaps be entitled "I told you so."A letter I wrote in response to the Wall Street Journal's "A Health-Tech Monopoly", Feb. 11, 2009 was published Feb. 18, 2009 under the header Dig…

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15 Jan 2013

ONC and "Health IT Patient Safety Action & Surveillance Plan": When Sociologists Uphold the Hippocratic Oath While Physicians Pay Respect to the Lords of Kobol, We Are in a Dark Place, Ethically

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.] I've been meaning to write more on the just-before-Christmas, Friday afternoon, minimal-visibility release of the ONC report I'd written about in my Dec. 23, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/12/oncs-christmas-confessional-on-health.html" target="_blank">ONC's Christmas Confessional on Health IT Safety: HIT Patient Safety Action & Surveillance Plan for Public Comment</a>."   (The ONC report itself is available <a href="http://www.healthit.gov/sites/default/files/safetyplanhhspubliccomment.pdf" target="_blank">at this link</a> in PDF.) The Boston Globe and Globe staff writer Chelsea Conaboy, however, have beaten me to the punch in the Jan. 3, 2013 article "Federal government releases patient safety plan for electronic health records", link below. ('<a href="http://en.wikipedia.org/wiki/Lords_of_Kobol" target="_blank">Lords of Kobol</a>', of course, is a pun.  They were fictional gods in a sci-fi series from the 1970's and a remake a few years ago, but in my circles the term is used satirically and derisively to reflect people expressing inappropriate overconfidence in - and perhaps worship of - computers.   <a href="http://en.wikipedia.org/wiki/COBOL" target="_blank">Cobol</a>, the COmmon Business-Oriented Language, is one of the oldest programming languages and was the major programming language of the merchant computing sector, including business, finance, and administrative systems for companies and governments.) First, I do want to reiterate what I'd mentioned in my earlier post:  the new ONC report is a sign of progress, in terms of a government body explicitly recognizing the social responsibilities incurred by conducting the mass human subjects experiment of national health IT.  However, I also wrote: <blockquote class="tr_bq">... [The ONC report] is still a bit weak in acknowledging the likely magnitude of under-reporting of medical errors, including HIT-related, in the available data, and the issue of risk vs. 'confirmed body counts' as I wrote at my recent post "<a href="http://hcrenewal.blogspot.com/2012/12/a-very-signifcant-additonal-observation.html" target="_blank">A Significant Additional Observation on the PA Patient Safety Authority Report -- Risk</a>". </blockquote> The Globe quoted a number of people involved the health IT debate, and I am now commenting on their Jan. 3 article: <blockquote class="tr_bq"><a href="http://www.boston.com/whitecoatnotes/2013/01/03/federal-government-releases-patient-safety-plan-for-electronic-health-records/KBqYjU4Gsup8vnx6ppgfOP/story.html?comments=all#readerComm" target="_blank">Federal government releases patient safety plan for electronic health records</a> Boston Globe</blockquote><blockquote>01/03/2013 11:16 AM    By Chelsea Conaboy, Globe Staff The federal office in charge of a massive rollout of electronic health records has issued a plan aimed at making those systems safer by encouraging providers to report problems to patient safety organizations. Though some in the field say it doesn’t go far enough, others said the plan is an important step for an office whose primary role has been cheerleader for a technology that has the potential to dramatically improve health care in the United States but that may come with significant risks.</blockquote> A major issue at the heart of the controversy is the fact that, admittedly, nobody knows the magnitude of the risks - in large part due to systematic impediments to knowing.  This has been admitted by organizations including the Joint Commission (<a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html" target="_blank">link</a>), U.S. FDA (<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">link</a>; albeit in an "internal memo" never intended for public view, and discovered only through the hard work of Center for Public Integrity investigative reporter Fred Schulte when he was at the Huffington Post Investigative Fund), Institute of Medicine of the U.S. National Academies (<a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">link</a>, quoted at midsection of post), and others.  I have made the claim that when you don't know the level of harm of an intervention in healthcare, and there are risk management-relevant case reports of dangers, you don't go gung-ho and start a national-scale implementation with penalties for non-adopters, and then decide to study safety, quality, usability etc.  You determine safety first in more controllable and constrained environments.  Anything else is, as I wrote, putting the cart before the horse (<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html" target="_blank">link</a>). <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/AVvXsEh7nInx820f0ENnQAtyZPnEg9adrMvhxLkh-27yVmfwbjwdrm-ybDsdcNvioqVXyXGr_jquEVlg5-HtZ-d5lkfacpkRkVIgVfJbGXHB6iEAHGFAMDFmOy8xsmqHRl_de_qjAh1p2VB0fpoC/s1600/horse-cart.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="131" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7nInx820f0ENnQAtyZPnEg9adrMvhxLkh-27yVmfwbjwdrm-ybDsdcNvioqVXyXGr_jquEVlg5-HtZ-d5lkfacpkRkVIgVfJbGXHB6iEAHGFAMDFmOy8xsmqHRl_de_qjAh1p2VB0fpoC/s200/horse-cart.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Things are a bit out of order here.</td></tr></tbody></table> You also certainly don't dismiss risk management-relevant case reports from credible observers as "anecdotal", the common refrain of hyperenthusiasts and (incompetent) scientists who conflate scientific research with risk management - as a researcher from Down Under eloquently observed in the Aug. 2011 guest post "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</a>."  Back to the Globe: <blockquote class="tr_bq"> A year ago, the Institute of Medicine issued a report urging the federal government to do more to ensure the safety of electronic health records. It highlighted instances in which the systems were linked to patient injury, deaths, or other unsafe conditions. The report suggested creating an independent body to investigate problems with electronic records and to recommend fixes, similar to how the National Transportation Safety Board investigates aviation accidents. Instead, the Office of the National Coordinator for Health Information Technology delegated various monitoring and data collection duties to existing federal offices, including the Agency for Healthcare Research and Quality [AHRQ].</blockquote> The problem is that <a href="http://www.ahrq.gov/" target="_blank">AHRQ</a> is a research agency (as its name suggests), has no regulatory authority nor any experience in regulation, and most clinicians have never heard of it.  In effect, this ONC recommendation is lacking teeth, even compared to the relatively milquetoast recommendations of IOM itself (as I wrote about in a Nov. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">IOM Report - 'Health IT and Patient Safety: Building Safer Systems for Better Care' - Nix the FDA; Create a New Toothless Agency</a>"). <blockquote class="tr_bq">The [ONC] office has asked patient safety organizations, which work with doctors and hospitals to monitor and analyze medical errors, to add health IT to their agendas. Data from the organizations would be aggregated by the agency, but reporting by doctors and hospitals is completely voluntary.  [A prime example of what I term an extraordinary regulatory accommodation afforded the health IT industry - ed.] </blockquote> Now we're into septic shock blood pressure-level weakness. Here is PA Patient Safety Authority Board Member Cliff Rieders, Esq. on mandatory, let alone voluntary reporting. From “Hospitals Are Not Reporting Errors as Required by Law", Philadelphia Inquirer, pg. 4, <a href="http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety" rel="nofollow" target="_blank">http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety:</a>    <blockquote class="tr_bq">... Hospitals don’t report serious events if patients have been warned of the possibility of them in consent forms, said Clifford Rieders, a trial lawyer and member of the Patient Safety Authority’s board. He said he thought one reason many hospitals don’t want to report serious events is that the law also requires that patients be informed in writing within a week of such problems. So, if a hospital doesn’t report a problem, it doesn’t have to send the patient that letter. [Thus reducing risk of litigation, and, incidentally, potentially infringing on patients' rights to legal recourse - ed.] Rieders says the agency has allowed hospitals to determine for themselves what constitutes a serious event and the agency has failed to come up with a solid definition in six years. Fixing this “is not a priority,” he added.</blockquote> To expect hospitals to voluntarily report even a relevant fraction of mistakes and near-misses out of pure altruism, or permit their clinicians to do so, with the inherent risks to organizational interests such reporting entails, is risible. The near-lack of reporting by most health IT sellers and hospitals in the already-existing FDA Manufacturer and User Facility Device Experience (MAUDE) database is substantial confirmation of that; the fraction of reports in MAUDE, however, are hair-raising.  See my Jan. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">MAUDE and HIT Risks: What in God's Name is Going on Here</a>?" for more on that issue. Here's an example of what happens to 'whistleblowers', even those responsible for system development and safety: "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit" target="_blank">A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge</a>." ONC's recommendations thus in my opinion reflect bureaucratic window dressing, designed to create progress - but progress that can probably be measured in microns. <blockquote class="tr_bq">“There was no evidence that a mandatory program was necessary,” Jodi Daniel, the [ONC] office’s director of policy and planning, said in an interview.</blockquote> Really?  See the aforementioned Philadelphia Inquirer article “Hospitals Are Not Reporting Errors as Required by Law", as well as numerous articles on pharma and medical device industry reporting deficits such as starting at page 5 in my paper "A Medical Informatics Grand Challenge: the EMR and Post-Marketing Drug Surveillance" <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Silverstein_Drug_Surveillance.pdf" target="_blank">at this link</a> in PDF. There is no evidence mandatory reporting is necessary ... to someone who's either naïve, incompetent - or persuaded, e.g. with money, to not find evidence or rationale. <blockquote class="tr_bq"> The [ONC] office has been under pressure to roll out the electronic health records systems quickly while protecting patient data and making sure that the systems don’t cause problems in medical care, said Dr. John Halamka, chief information officer at Beth Israel Deaconess Medical Center. </blockquote> Under pressure by the health IT lobby, perhaps; but nobody else that I can think of. <blockquote class="tr_bq">“It’s this challenging chicken-and-egg problem,” he said. </blockquote> No, actually, it isn't.  Patient safety must come first. This becomes clear when one considers the late 5th century BC ethical principle <a href="http://en.wikipedia.org/wiki/Primum_non_nocere" target="_blank">Primum non nocere</a> ("first, do no harm" or "abstain from doing harm") versus the late 20th and early 21st century IT-hyperenthusiast credo I've expressed as "<a href="http://hcrenewal.blogspot.com/2011/10/cybernetik-uber-alles-computers-have.html" target="_blank">Cybernetik Über Alles</a>"  ("Computers above all"). Under CÜA, the computer has more rights than the patients, and the IT industry receives extraordinary regulatory accommodation to sloppy practices that no other healthcare or mission-critical non-healthcare sector enjoys. I sent Dr. Halamka a set of arguments such as I make here, and a picture of a health IT 'chicken', my deceased mother in her death robes. I received back a "thank you for the views" message - but no condolences.  (It occurs that I have rarely if ever received condolences from any senior HIT-hyperenthusiast Medical Informatics academic or government official to whom I've mentioned my mother.  Not to play amateur psychologist, but I believe it reflects the level of disdain or even hatred felt by these people towards health IT iconoclasts/patient's rights advocates.) <blockquote class="tr_bq">The plan, which is subject to public comment through Feb. 4, “is a reasonable start,” in part because it puts more pressure on hospitals and doctors to monitor safety, Halamka said. </blockquote> As I expressed to Dr. Halamka, we are in agreement on that point. <blockquote class="tr_bq"> The government would have risked stifling innovation in the industry if it had opted instead to require the kinds of tests and review by the Food and Drug Administration that new medical devices and drugs must go through, he said.</blockquote> To that, I mention here (as I did in my email to him) my response to this industry meme, as I had expressed it at Q&A after my August 2012 <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">keynote address to the Health Informatics Society of Australia</a>: <blockquote class="tr_bq">... I had a question from the audience [after my talk], from fellow blogger <a href="http://thehealthcareblog.com/blog/category/matthew-holt/" target="_blank">Matthew Holt of the Health Care Blog</a>.  (I've had some online debate with him before, such as in the comment thread at my April 2012 post <a href="http://hcrenewal.blogspot.com/2012/04/allscripts-shares-plunge-on-weak.html" target="_blank">here</a>.) Matthew asked me a somewhat hostile question (perhaps in retaliation for the thrashing he received at the end of my May 2009 post on the WaPo's HIT Lobby article <a href="http://hcrenewal.blogspot.com/2009/05/machinery-behind-healthcare-reform-how.html" target="_blank">here</a>), that I was well prepared for, expecting a question along these lines from the seller community, actually.  The question was preceded by a bit of a soliloquy of the "You're trying to stop innovation through regulation" type, with a tad of Merck/VIOXX ad hominem thrown in (I ran Merck Research Labs' Biomedical libraries and IT group in 2000-2003). His question was along the lines of - you were at Merck; VIOXX was bad; health IT allowed discovery of the VIOXX problem by Kaiser several years before anyone else; you're trying to halt IT innovation via demanding regulation of the technology thus harming such capabilities and other innovations. The audience was visibly unsettled.  Someone even hollered out their disapproval of the question. My response was along the lines that: <ul><li>VIOXX was certainly not Merck at its best, but regulation didn't stop Merck from "revolutionizing" asthma and osteoporosis via Singulair and Fosamax;</li><li>That I'm certainly not against innovation; I'm highly pro-innovation;</li><li>That our definitions of "innovation" in medicine might differ, in that innovation without adherence to medical ethics is not really innovation.  It is exploitation.</li></ul></blockquote> I stand by that assessment. More from the Globe article: <blockquote class="tr_bq">There is little good research into how the systems improve health care and there are big obstacles to fixing even the known problems, said Ross Koppel, a professor of sociology at the University of Pennsylvania who studies hospital culture and medication errors. Some developers require providers to sign nondisclosure agreements before using their systems, and the safety plan does not prohibit such gag clauses.  [Note: I wrote on this issue <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda" target="_blank">here</a>, and in a published July 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" <a href="http://jama.jamanetwork.com/article.aspx?articleid=184302" target="_blank">here</a> - ed.]  While the plan addresses reporting of known problems, Koppel said it will not help researchers and developers understand problems that go unnoticed but that may be causing real patient harm.  “We only know the tip of the iceberg” about how electronic health records affect patient care, said Koppel, who was an official reviewer for the Institute of Medicine report. </blockquote>As per the title of this blog post, we are in a dark place, ethically, when a PhD sociologist who's never taken the Oath of Hippocrates (to my knowledge) appears to express more concern for patient safety and patient's rights than a Harvard physician-informatics Key Opinion Leader such as Dr. Halamka. <blockquote class="tr_bq">Koppel said the mantra of the Office of the National Coordinator has been that more health IT leads to better health care. “It probably is better than paper,” he said, “but it could be so much better than it is.”</blockquote> I agree, but with caveats.  I opine that bad health IT is likely worse for patients than a good, well-staffed paper based system.  For instance, the former can cause systematic dangers that even a bad paper system cannot, such as tens of thousands of prescription errors (see my Nov, 2011 post "<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank">Lifespan Rhode Island: Yet another health IT 'glitch' affecting thousands - that, of course, caused no patient harm that they know of - yet</a>") or mass privacy breaches (see the current 30 or so posts on that issue at this blog query link: <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy" target="_blank">http://hcrenewal.blogspot.com/search/label/medical record privacy</a>). On good health IT and bad health IT from my teaching site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/</a>: <blockquote class="tr_bq"> Good Health IT ("GHIT") is IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealthinformation secure, protects patient privacy and facilitates better practice of medicine and better outcomes.  Bad Health IT ("BHIT") is IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  </blockquote> The Boston Globe article concludes: <blockquote class="tr_bq">Ashish Jha, associate professor of health policy at Harvard School of Public Health and a member of the panel that drafted the Institute of Medicine report, said he wants doctors to be able to report problems -- errors in medication lists, for example -- in real-time so they can be found and fixed quickly. The safety plan does not require systems to have that capability, but Daniel said her office could soon add such a requirement for products that receive federal certification. The bigger problem is that health care as a whole needs a better way of tracking patient safety, Jha said. Monitoring issues caused by electronic health records “should be a part of it, and then we can actually know if this is a small, medium or large contributor to patient safety issues,” he said. “But we don’t know that.”</blockquote> I agree with Dr. Jha, but the IT sellers and healthcare organizations will (legitimately) claim that adding real-time error reporting/forwarding to their products will be extremely resource-intensive. I have an alternate approach that will require little effort on the part of the sellers and user organizations. <ul><li>Post a message at the sign-in screen of all health IT along the lines that "This technology is experimental, adopted willingly by [organization] although not rigorously vetted for safety, reliability, usability, nor fitness for purpose, and thus you use it at your own risk.  If problems occur, report them to the following" ...</li></ul> "The following" could include a list of alternatives such as I wrote in my Aug. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/clinicians-how-to-document-ehr-screens.html" target="_blank">Clinicians: How to Document the EHR Screens You Encounter That Cause Concern</a>." <div class="date-posts"><div class="post-outer"><div class="post hentry" itemprop="blogPost" itemscope="itemscope" itemtype="http://schema.org/BlogPosting"><a href="http://www.blogger.com/blogger.g?blogID=9551150" name="613349029890366576"></a> <div class="post-body entry-content" id="post-body-613349029890366576" itemprop="description articleBody"><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): <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 insurance carriers, 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 requiring 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> </blockquote></div><div class="post-body entry-content" id="post-body-613349029890366576" itemprop="description articleBody">See the actual post for an idea about clinicians seeking indemnification when forced by healthcare organizations to use bad health IT.  I can attest to actually seeing HIT policies that call for "human resources actions" if clinicians refuse to use HIT, or cannot learn to use it at a sufficient pace. (Left out of this reiteration is the demonstration on photographing problematic EHR screens.  See the post for the details - it is easy to do, even with a commodity cellphone.) HHS should be promoting laws on protection from retaliation upon clinicians reporting problems in good faith. Thus, physicians, nurses and other clinicians can create needed health IT transparency and help our society discover the true level of risks of bad health IT.  They simply need the right information on what to do and where to report, bypassing the ONC office and, in the spirit of medicine, taking such matters into their own hands in the interests of patient care and medical ethics. I also made recommendations to the Pennsylvania Patient Safety Authority on how known taxonomies of health IT-related medical error can be used, and need to be used, to promote error reporting in common formats.  Slides from my presentation to the Authority entitled "Asking the Right Questions:  Using Known HIT Safety Issues to Improve Risk Reporting and Analysis", given in July 2012 at their invitation, are at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt" rel="nofollow" target="_blank">http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt</a> Finally, another sign of progress:  unlike the HITECH Act, this new ONC plan is open to public comment. -- SS Addendum Jan. 8., 2012: Dr. Halamka has put more details regarding his views in his blog.  The entry is entitled "Electronic Health Record Safety" at this link:  <a href="http://geekdoctor.blogspot.com/2013/01/electronic-health-record-safety.html">http://geekdoctor.blogspot.com/2013/01/electronic-health-record-safety.html .</a> He writes: <blockquote class="tr_bq">... Some have questioned the wisdom of moving forward with EHRs before we are confident that they are 100% safe and secure.   [That, of course, is not my argument - nothing is ever 100% safe and secure.  However, we don't yet know just how safe and secure - or unsafe and insecure - HIT is.  That is the issue I am concerned about - ed.] I believe we need to continue our current implementation efforts. I realize it is a controversial statement for me to make, but let me use an analogy. When cars were first invented, seat belts, air bags, and anti-lock brakes did not exist.    Manufacturers tried to create very functional cars, learned from experience how to make them better, then innovated to create new safety technologies. many of which are now required by regulation. Writing regulation to require seat belts depended on experience with early cars. My grandmother was killed by a medication error caused by lack of an EHR.  My mother was incapacitated by medication issues resulting from lack of health information exchange between professionals and hospitals.   My wife experienced disconnected cancer care because of the lack of incentives to share information.     Meaningful Use Stage 2 requires the functionality in EHRs which could have prevented all three events.</blockquote> I express my condolences on those events. I disagree, however, with continuing national implementation efforts at the current rate, with penalties for non-adopters.  I opine from the perspective of believing health IT has not reached a stage where it is ready for national rollout and remains experimental, its magnitude of harms admittedly unknown and information flows systematically impaired.  I recommend and prefer great caution under those circumstances, and remediation of those circumstances before full-bore national implementation. I will leave it to the reader ponder the two views. -- SS</div></div></div></div>

ONC and "Health IT Patient Safety Action & Surveillance Plan": When Sociologists Uphold the Hippocratic Oath While Physicians Pay Respect to the Lords of Kobol, We Are in a Dark Place, Ethically

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.]I've been meaning to write more on the just-before-Christmas, Friday afternoon, minimal-…

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05 Jan 2013

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