healthy4u: PICIS Pulsecheck

A Good Way to Cybernetically Harm or Kill Emergency Department Patients ... Via An ED EHR "Glitch" That Mangles Prescriptions

Yet another healthcare IT "glitch" - that banal little word used for potentially life-threatening software defects.  (See the query link <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> for more examples.) An EHR/command and control system (including ordering, results reporting, etc.)  for hospital Emergency Departments, Picis Pulsecheck, was recalled by FDA. Reason?  "Notes associated with prescriptions are not printed to the prescription or to the patient chart."  The data apparently is not being sent to the printer or being stored for future visits.  Instead, data input by clinical personnel, in one of the most risk-prone medical settings, the Emergency Department, is simply going away. This is reminiscent of the truncation of prescription drug "long acting" suffixes, apparently by a Siemens system, that led to thousands of prescription errors (perhaps tens of thousands) over more than a year's time.  I wrote about that matter, as reported by the news media, at "Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet" at <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html</a>.  Regarding the current Picis recall, notes connected with prescriptions can be crucial to the pharmacist or the patient.  Loss of those notes - apparently due to a computer glitch and most likely in this case without the prescribing clinician knowing about it - likely have been going on for some time now, since two software versions (5.2 and 5.3) are affected. The solution for now? <blockquote class="tr_bq">"Consignees were provided with recommended actions until they receive the necessary update."</blockquote> In other words, a workaround adding more work to clinicians who now not only have to take care of patients, but in the unregulated health IT market need to (as if they don't already have enough work to do in the ED where chaos often occurs) babysit computer glitches as well - and pray they catch potential computer errors 100% of the time. Below is the FDA MAUDE recall notice at "Medical & Radiation Emitting Device Recalls", from <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119832">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119832</a>. <a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1814-2013&w=08072013&lang=eng">At this additional link</a> we find that this FDA recall was "Voluntary: Firm Initiated."  They apparently informed the FDA of the "glitch." My question is - how did the company become aware of this "glitch"?  Also, were any patients put in harm's way, or injured, as a result of the prescription data loss? <a href="https://www.blogger.com/null" id="main" name="main"></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/AVvXsEh9P8LdAz5mRrOdrPBe9rkYWKhLdAuDrte6fxAO8peB0pBq7OJZbKHtwkwveUP0nsVxmBA2GKX-3R-bY8xq_4vc_-svQqadoh2lFek-y6VPNTzUca-ytPmktoeEQQ1AJptfBjAqitxv-ARC/s1600/picis_recall2.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh9P8LdAz5mRrOdrPBe9rkYWKhLdAuDrte6fxAO8peB0pBq7OJZbKHtwkwveUP0nsVxmBA2GKX-3R-bY8xq_4vc_-svQqadoh2lFek-y6VPNTzUca-ytPmktoeEQQ1AJptfBjAqitxv-ARC/s1600/picis_recall2.jpg" width="351" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">FDA Device Recall Notice.  Click to enlarge; text below.</td></tr></tbody></table> <blockquote class="tr_bq"> <table cellpadding="0" cellspacing="0" style="width: 100%px;"><tbody><tr><td width="33%"> </td><td align="left" style="color: #23238e; font-family: arial; font-size: 11pt; font-weight: bold;" width="34%">Class 2 Recall ED PulseCheck</td><td align="right" width="33%"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/relateditems.cfm?page_title=medical%20device%20recalls&item1_text=medical%20device%20recalls%20&item1_url=www.fda.gov/medicaldevices/safety/recallscorrectionsremovals/listofrecalls/default.htm&item2_text=fda%20enforcement%20report%20index&item2_url=www.fda.gov/safety/recalls/enforcementreports/default.htm"></a> </td></tr></tbody></table><table cellpadding="2" cellspacing="14"><tbody><tr> <th align="left" valign="top">Date Posted</th> <td align="left" valign="top">July 29, 2013</td> </tr><tr> <th align="left" nowrap="nowrap" valign="top">Recall Number</th> <td align="left" valign="top">Z-1814-2013</td> </tr><tr> <th align="left" valign="top">Product</th> <td align="left" class="hardbreak" valign="top">Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.</td> </tr><tr> <th align="left" valign="top">Code Information</th> <td align="left" valign="top">Software Versions 5.2 and 5.3</td> </tr><tr> <th align="left" valign="top">Recalling Firm/ Manufacturer</th> <td align="left" valign="top">Picis Inc. 100 Quannapowitt Parkway Suite 405 Wakefield, Massachusetts 01880</td> </tr><tr> <th align="left" valign="top">For Additional Information Contact</th> <td align="left" valign="top">Support Representative 781-557-3000 </td> </tr><tr> <th align="left" nowrap="nowrap" valign="top">Reason for Recall</th> <td align="left" valign="top">Notes associated with prescription are not printed to the prescription or to the patient chart. </td> </tr><tr> <th align="left" nowrap="nowrap" valign="top">Action</th> <td align="left" valign="top">Initial customer notifications were sent via email on June 21, 2013 informing consignees of the recall and providing further instruction regarding the software solution. Consignees were provided with recommended actions until they receive the necessary update.</td> </tr><tr> <th align="left" nowrap="nowrap" valign="top">Quantity in Commerce</th> <td align="left" valign="top">35</td> </tr><tr> <th align="left" nowrap="nowrap" valign="top">Distribution</th> <td align="left" valign="top">Nationwide Distribution, including the states of: AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV.</td></tr></tbody></table></blockquote>Finally, I ask - how did this "glitch" escape the notice of the company before the software was put into production not in just one, but through two sequential versions? I propose that the lack of health IT regulatory controls due to special accommodation makes thorough software testing less "desirable" by a company (largely due to costs). Compare that to, say, software regulation in the Federal Aviation Administration: <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="http://www.faa.gov/documentLibrary/media/Order/8110.49%20Chg%201.pdf"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEijSv2nvIBYRtaq5Pv325j8_DLtIo_gReEvwpmezb_m6og2xIqMvpBwN4YxpERbCWff43VUyGuLrwOugZ4TLqYXVAMru4DCjbzBtf9j3cTDxUb8GNtB_YKT18MQFj_CqKKurXiG18YHpXML/s1600/faa_approval.jpg" width="247" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">FAA Aircraft Software Approval Guidelines - available at <a href="http://www.faa.gov/documentLibrary/media/Order/8110.49%20Chg%201.pdf">http://www.faa.gov/documentLibrary/media/Order/8110.49%20Chg%201.pdf</a>.  Click to access.</td></tr></tbody></table> The FAA document begins: <blockquote class="tr_bq">"This order establishes procedures for evaluating and approving aircraft software and changes to appropriate approved aircraft software procedures."</blockquote> Software regulation in other mission critical industries like aviation and pharma make the health IT industry and its lack of regulation look pathetic. -- SS

A Good Way to Cybernetically Harm or Kill Emergency Department Patients ... Via An ED EHR "Glitch" That Mangles Prescriptions

Yet another healthcare IT "glitch" - that banal little word used for potentially life-threatening software defects. (See the que...

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EHR Advertising Obscenity ... Is This An Emergency Department, or a Bar Mitzvah?

Regarding unregulated, unvetted information technology installed in acute care environments such as ED's, that slows physicians down and increases risk, this video is perhaps typical of the cavalier attitudes of hospital executives and <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">IT hyper-enthusiasts</a>. I have personally observed potentially serious malfunctions involving allergy lists and med lists exhibited by particular system, in fact. Click the image below to play the video.  Have nausea bag nearby: <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="http://www.youtube.com/watch?v=qemT6xlqheY"><img a="" border="0" height="233" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhGaHZwdwuETsY7-aDJEj3lJK9waLtlfe36gAZJTps58VkRpcUwVy9bi7aRLs0CnMShd4I4fDhvfzz_jATQQgMiFYshxSMLUZJoy8qQ_aw18xbulgtBmDzda1N7fVediJT7g4VFNT6c90zY/s400/pulsecheck.bmp" style="margin-left: auto; margin-right: auto;" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Click on this image or <a href="http://www.youtube.com/watch?v=qemT6xlqheY" target="_blank">here</a> to see a charmingly disgusting song & dance.</td></tr></tbody></table> ED's are all about dancing: <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/AVvXsEgP2IscBKoegPdwcldVXiQmEQElRXJeTB4hrq-Pv16z9X6DE0gSp-ReS2IITXqMkceaNf7PZaasCRoCikKwHXqMHq-jPe3jzbeQ6RXlZiDR5U2ApKRXY5i-JG3OH7SXye1Of_cR2Cs563VN/s1600/dance.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="265" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgP2IscBKoegPdwcldVXiQmEQElRXJeTB4hrq-Pv16z9X6DE0gSp-ReS2IITXqMkceaNf7PZaasCRoCikKwHXqMHq-jPe3jzbeQ6RXlZiDR5U2ApKRXY5i-JG3OH7SXye1Of_cR2Cs563VN/s400/dance.bmp" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">If you change your mind, I'm the first in line Honey I'm still free Take a chance on me</td></tr></tbody></table> Note the (not so subliminal) message shown by the nurses and their dollar-sign glasses in the video ... higher billing ... more revenue: <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/AVvXsEj09YSQDv7XFo8wKQaY3-6GYqS0b1uU-Q8lBMM9sad2yRaJF9Rk4wJsYaKA9IO6QB88lJc3sVOkGNMvl9kFiAQVhqntV-PKf3YdaJLtA1eDkgW6_vjIpuX82tCcsw9FHGGWdRM4OANpLKY7/s1600/billmore.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="242" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj09YSQDv7XFo8wKQaY3-6GYqS0b1uU-Q8lBMM9sad2yRaJF9Rk4wJsYaKA9IO6QB88lJc3sVOkGNMvl9kFiAQVhqntV-PKf3YdaJLtA1eDkgW6_vjIpuX82tCcsw9FHGGWdRM4OANpLKY7/s400/billmore.bmp" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Money, money, money - Must be funny - In the rich man's world ... I see dollar signs everywhere!! </td></tr></tbody></table> Yes, ED's are just filled with fun and laughter and dancing while doctors and nurses toil with distracting EHRs ... to rake in more dough, which makes it all OK, right? I note that ED's are places where people are regularly brought in with major traumas and in fact regularly die; they are the most serious of environments. This video advertisement is absolutely tasteless on its face. Note:   I've downloaded a copy of this video, in case it disappears off YouTube.  Such things are <a href="http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html" target="_blank">known to happen in the health IT world</a>. -- SS 3/27/13 Addendum: For similar tastelessness direct from HHS, see my May 2012 post "<a href="http://hcrenewal.blogspot.com/2012/05/oncs-health-data-palooza-title-of.html" target="_blank">ONC's 'Health Data Palooza' - A Title of Exceptionally Bad Taste</a>."

EHR Advertising Obscenity ... Is This An Emergency Department, or a Bar Mitzvah?

Regarding unregulated, unvetted information technology installed in acute care environments such as ED's, that slows physicians down and...

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Healthcare IT Transparency Could Stand Some Improvement

Transparency in the health IT sector is akin to the transparency of Pb (lead). The following report comes from the FDA Maude (<a class="l" href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">Manufacturer and User Facility Device Experience</a>) voluntary-reporting database, reported by a (likely unhappy) biomedical engineer a month after the "incident" - the nature of which is deliberately kept hidden.  This is regarding the <a href="http://www.picis.com/solutions/emergency-department/ed-pulsecheck.aspx" target="_blank">PICIS "Pulsecheck" EHR</a> for emergency departments: <blockquote class="tr_bq"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1725683" target="_blank">Report Date     05/14/2010</a> PICIS INC. CARESUITE ED PULSECHECK S/W, TRANSMISSION & STORAGE PATIENT DATA Event Type:  Other Patient Outcome:  Required Intervention Event Description The customer has reported a patient incident that has prompted a review of their internal process and possible issues surrounding the incident. The customer report alleges the involvement of picis' ed (emergency dept. ) electronic health record application, whereby, duplicate results were received by the picis ehr application from an enterprise info system, which, when displayed in their entirety may have contributed to some degree of confusion for the treating physician - the context of which the customer has declined to clarify any further.  [What in the world? -ed.] At this time, we have been informed by the customer that they are restricted by senior leadership from disclosing any specific details regarding the patient's status, the specific type of result or evidence of application performance to support picis' investigation.</blockquote> "Restricted by senior leadership from disclosing any specific details regarding the patient's status, the specific type of result or evidence of application performance to support Picis' investigation?" That is perverse on its face, and probably in violation of Joint Commission safety standards on reporting of incidents that could affect other organizations. <blockquote class="tr_bq">Manufacturer Narrative Picis' investigation into the reported incident is based on a limited exchange of info with the customer, as well as our internal review of the application design and current configuration in use at the reporting site. Review of configuration files, existing system build at the client site, interface specification documents and previous customer communications demonstrate that the customer implemented and accepted the picis edis in 2008. During this process, the picis edis system was configured to display all results sent from the customer's enterprise system rather than configuring the results display in 'overwrite' mode. Prior to acceptance, an investigation by picis and the client revealed that it was the sending system, sending multiple duplicate results messages [great quality - ed.] and a request was made by the customer of that enterprise vendor [I can only wonder who that was - ed.] to investigate. However, due to the enterprise system's protocol for 'add on' tests, it was not possible to utilize the 'overwrite' configuration due to the risk of filtering out unique results and subsequently not presenting the clinicians with important info. Therefore, the customer elected to have all results displayed. </blockquote> A workaround that apparently, from the limited information provided, led to physician confusion..."the context of which the customer had", not very helpfully, "declined to clarify any further." <blockquote class="tr_bq">Hospitals also are required to have add'l safeguards in place for the handling of critical results including expedited reporting of critical results with a licensed responsible caregiver rather than relying solely on standard results reporting processes (joint commission national patient safety goal 02. 03. 01).</blockquote> This is not a resounding statement of confidence in health IT... <blockquote class="tr_bq">The customer is currently working with a 3rd party integration consultant to improve the handling of results sent to picis' electronic health record application. We are providing support as it is requested. At this time, no corrective action is needed.  </blockquote> The "senior leadership" that withheld details was protecting what, exactly?  Money and contracts, perhaps; conflicts of interest, possibly ... but not patients. All I can say is: Imagine if this was a report on a new drug suspected of harming people.  What in heaven's name was going on here? As I've written many times, and as illustrated by this MAUDE report, the health IT industry must first be transformed into one of evidence-driven IT practices and transparency before anyone touting its products has any business even speaking about the technology "transforming medicine." -- SS

Healthcare IT Transparency Could Stand Some Improvement

Transparency in the health IT sector is akin to the transparency of Pb (lead). The following report comes from the FDA Maude ( Manufacturer ...

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