healthy4u: #HITsm

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

<div style="text-align: center;">[Note to the humorless:  this post is satirical and sardonic to make a very serious point about the perversity of downplaying/ignoring health IT risks, issues too often ignored by those who know better.  If you don't like satire, don't read it.] </div> I've been critiqued for posting in too gloomy a manner for some's taste, even those who like me are in the Medical Informatics field.  For example, in the Feb. 2013 Kaiser Health News article "Health Technology’s ‘Essential Critic’ Warns Of Medical Mistakes" at <a href="http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx">http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx</a>: <blockquote class="tr_bq">... Many say he comes on too strong. Even admirers cringed when he began blogging about the 2011 death of his mother, which he blames in a lawsuit on a computer error that allegedly caused Abington Memorial Hospital to overlook a key medication. (Both he and the hospital said they couldn’t comment on a pending suit.) Personalizing his campaign, some thought, made him seem less objective.</blockquote> Of course, if a close relative of these unnamed "many" were killed by, say, a drunk driver (something this unobjective group of mothers takes seriously:  <a href="http://www.madd.org/">http://www.madd.org/</a>), or if their child were abducted and decapitated (<a href="http://en.wikipedia.org/wiki/Murder_of_Adam_Walsh">http://en.wikipedia.org/wiki/Murder_of_Adam_Walsh</a>), or if something like this event (<a href="https://www.youtube.com/watch?v=55XJivhjB4U">https://www.youtube.com/watch?v=55XJivhjB4U</a>) happened, their response would surely be "oh well, stuff happens, let's all be 'objective', not 'personalize' things, not advocate with our personal stories, and above all, be happy!    <div class="separator" style="clear: both; text-align: center;"> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgz2Sc_Ep0eHVvzgNTK2PPqnYAKho1OUX3pg4Y8MMphHPtZ3nKt71CbjXSeq3PvKwzIPeU6vw8CW5WskPOtYVfQe2bYtIbV9DW-T1KShF-n_EMiMdFwTzT_HR-m58p4oHUhj1JuMVtKbhpg/s1600/smiley.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgz2Sc_Ep0eHVvzgNTK2PPqnYAKho1OUX3pg4Y8MMphHPtZ3nKt71CbjXSeq3PvKwzIPeU6vw8CW5WskPOtYVfQe2bYtIbV9DW-T1KShF-n_EMiMdFwTzT_HR-m58p4oHUhj1JuMVtKbhpg/s1600/smiley.jpg" /></a></div> I really do admire the unnamed "many" for their ability to detach, so am presenting the following story of "anecdotal" patient harm to a child in a pediatric ICU in the spirit of happiness, joy, and Mother's Day love! <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj1nVbtntosQYTim-y3sdm6vTMvInD2jgP1ZlsrcxGevCVfigNMgPvzd8HUqh4qznVDYUP4YCPDpMpgcXg4RaT3XCIO4RjdDTdAPL_aExrCYK3A5ePMQZwv8cEk2lGgbZspCOR74YLbtkRd/s1600/vintage_housewife_cook.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj1nVbtntosQYTim-y3sdm6vTMvInD2jgP1ZlsrcxGevCVfigNMgPvzd8HUqh4qznVDYUP4YCPDpMpgcXg4RaT3XCIO4RjdDTdAPL_aExrCYK3A5ePMQZwv8cEk2lGgbZspCOR74YLbtkRd/s1600/vintage_housewife_cook.jpg" width="175" /></a></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiBVdvcXC2vRHlGd1UhzTgr2F7Ut7bWo3S_ppYkE1Ji-F5AMjm1uHvJx2apITS82nBcYMZDHEVDUwW7IUVMpLLc22Y-7Q318dPGia2NwyjsGojNmzNO4Hpsovvd2f9c42UgYEeaEuEq755A/s1600/smiley1.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"> </a></div> Here's the event we should all be happy about, reported via FDA - I note the FDA's said these devices are not "sufficiently risky" to warrant a high level of their attention even though they secretly admitted in an internal memo that there's no way to really know te true level of risk and harm (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>), so clearly they're all a really jolly bunch: <blockquote class="tr_bq"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=117690">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=117690</a> FDA MedSun report Type of device: medical device data system Device brand name: PowerChart Device manufacturer's name: Cerner Corporation Date of this report: (mm/dd/yyyy) 03/04/2014 Describe the event or problem:     Medication Error. This event was related to Health Information Technology. Specifically, the manner in which the system processed an order for free water replacement. Order was intended to be 20ml/hr for 6 hours for a total of 120ml. It was a 1000 ml bag so first they put 20ml/hr which would have defaulted the infuse over time to 50 hrs. They tried to change the infuse over to 6 hours which then changes the ml/hr rate to 167 ml/hr. They did not notice this had changed. </blockquote> Well, that's WONDERFUL!!  :-)  that the computer recalculates the flow rate for them when they change the infusion time, by paternalistically assuming that's what they wanted to do - change the RATE of infusion - when what they actually did is manually change the TIME (duration) of infusion.  How LOVELY of some programmer to have given them this FANTASTIC convenience!! <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/AVvXsEi8yEnZHeor2UZZlhUf4qKrE_4fxFfxrQna0eHhEQagUgU-_a9j1wpRZEfLCAMhkhyphenhyphenOsXIplxq3wLZU4cE3m0rrvjUniE-RugNfZbwUtYsoZXALSsI9k4Grh7jfb78Uc0hHnW_Eh6NGrjDg/s1600/behappy.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi8yEnZHeor2UZZlhUf4qKrE_4fxFfxrQna0eHhEQagUgU-_a9j1wpRZEfLCAMhkhyphenhyphenOsXIplxq3wLZU4cE3m0rrvjUniE-RugNfZbwUtYsoZXALSsI9k4Grh7jfb78Uc0hHnW_Eh6NGrjDg/s1600/behappy.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Aren't computers wonderful!!!</td></tr></tbody></table> Even the following should not be cause for ardent technophiles to wipe the smile from their downside-ignoring faces!! <blockquote class="tr_bq">... They did not realize that they needed to go into details tab to show the time frame so the patient got 167ml/hr instead of 20ml/hr for 6 hours. </blockquote> How obvious!!!  Every doctor, nurse, medical student and janitor knows from time immemorial knows you have to go into the detail tab to show the time frame!  (Smile) <blockquote class="tr_bq">... Order was verified by pharmacy and administered at that rate via peripheral IV. After approximately 1L of fluid had infused, patient showed seizure activity.  PICU (pediatric ICU) team called to bedside. Treatment provided for seizures and critical sodium and potassium. </blockquote> Awww ...  some seizures and critical sodium and potassium levels in the PICU.  Awww.....too bad!!!  We should be happy anyway!  For if this child died...the sacrifice would have been WORTH IT for the betterment of electronic medical records worldwide, and the parents no doubt would be flattered and joyous about their contribution to computing science.  After all, how better to figure out how to make this technology work?? After all, it takes a few broken eggs to make an omelette, and a few bumps in the road (like grave mounds) should be of little concern. Because, remember ... w.e. c.a.r.e! <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/AVvXsEiyOy_d372Rp11w3A5pCQBf6qnkp-yS-f-doYNL_pYtAkTMY8Rzj24CbQOHIUMcYdrEvM8d38R1Y1DKCwpakFqeoc3ZHv67S5PpRuDwz-sq_fpE3DstFh_OLkzQGej3MaZbuWAuHH8BQPTe/s1600/words+that+work.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiyOy_d372Rp11w3A5pCQBf6qnkp-yS-f-doYNL_pYtAkTMY8Rzj24CbQOHIUMcYdrEvM8d38R1Y1DKCwpakFqeoc3ZHv67S5PpRuDwz-sq_fpE3DstFh_OLkzQGej3MaZbuWAuHH8BQPTe/s1600/words+that+work.jpg" width="155" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">i c.a.r.e!!!!  As at U. Arizona Healthcare System, let's only use Happy Words with our patients about these systems! (click to enlarge, see <a href="http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html">http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html</a> )</td></tr></tbody></table> Further, we should use only Words That Work to describe the wonders of these systems in their current state!!! <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/AVvXsEjgAtZ_SQ0RVtQt8McdXxf2OEPLie5Sk706vuqci5i-jIWHJpJS0iZa7s09yVFO41Bbwq4GvWWpzRRMw9AxeldgzFHxb18eCHSaTtZn73KyFqrypUR2XyQHFf_UhSsRPXw0U5t4WQSm3fFv/s1600/flowers.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjgAtZ_SQ0RVtQt8McdXxf2OEPLie5Sk706vuqci5i-jIWHJpJS0iZa7s09yVFO41Bbwq4GvWWpzRRMw9AxeldgzFHxb18eCHSaTtZn73KyFqrypUR2XyQHFf_UhSsRPXw0U5t4WQSm3fFv/s1600/flowers.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Some flowers from Cerner CEO Patterson to momma to make up for her little baby having seizures and critically deranged potassium and sodium levels from those big, bad doctors' EHR mistake!</td></tr></tbody></table> <blockquote class="tr_bq">... The Cerner powerchart software system has functionality for continuous medications/fluid ordering that does not prevent "user error." </blockquote> Ut oh ... Looks like I'm going to have to be a sourpuss for just a moment and re-introduce the nasty, ill-tempered, non-objective idea of what the dastardly National Institute of Technology and Standards (NIST) calls "use error" (as opposed to "user error", A.K.A. "Blame the User",  <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html</a>): <blockquote class="tr_bq">... The EUP (EHR usability protocol) emphasis should be on ensuring that necessary and sufficient usability validation and remediation has been conducted so that use error [3] is minimized. [3] “Use error” is a term used very specifically to refer to user interface designs that will engender users to make errors of commission or omission. It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging [or lack of messaging, e.g., no warnings of potentially dangerous actions - ed.], misuse of color-coding conventions [see below], omission of information, etc. </blockquote> Awwwwww....aren't I just mean and non-objective? <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/AVvXsEh8h7Y65reXdJO632szxyY2e3UhlY3P8xr5VhF4vPIz_8cTZXCU_8L4DKIks0v0LLVJwWrKKd9BzQKa7OJpJv5NXGJkqpvjMd7xKU1mjfEaUD6F7MkhesXaq0Gw_4wHcv1DTduyxsr3atPO/s1600/frown.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="165" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh8h7Y65reXdJO632szxyY2e3UhlY3P8xr5VhF4vPIz_8cTZXCU_8L4DKIks0v0LLVJwWrKKd9BzQKa7OJpJv5NXGJkqpvjMd7xKU1mjfEaUD6F7MkhesXaq0Gw_4wHcv1DTduyxsr3atPO/s1600/frown.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"> </td></tr></tbody></table> That mean doctor Silverstein's just not happy and objective!!  Bad, bad, bad man! <blockquote class="tr_bq">... When the provider orders the fluid, example is D5W, the screen opens to a "continuous details" ordering window. Within the screen, the ordering provider is presented with a preselected bag volume and type of fluid with a brownish background. They have the ability to modify bag volume but it was made this color to discourage that change by Cerner. </blockquote> Golly gee!  There's something to be happy about once again!  Brown, the universally-understood color, in any language, means "Warning, do not change this value, it could kill someone!!!" See how GOOD this technology really is!!!  Why use alerts and confirmation dialogs when a mere COLOR like brown suffices!! <blockquote class="tr_bq"> ... The rate and "infuse over" fields are a yellow color to show that they need to be completed. The intent [of the programmer, clearly an expert in human-computer interaction and communication by color and smoke signals - ed.] is for an ongoing continuous fluid and not to limit the time. </blockquote> Golly Gee Times Two!  Yellow, the absolutely universal color for "Warning, you need to complete this to prevent killing someone!"   <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/AVvXsEiB07i36jmKHcewYx3Gz9u_Dn1b_sU77r5meRSlFySibvF182tqSVyjtTqOuue6t6pDz1RWP6W580szZKrms1eEmRSb_RIpzZGgVfKNduKoAx7uHGW2dKivEC1nq0UCSXHoKm4H1Q_gHPfw/s1600/yellow-light.jpeg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="133" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiB07i36jmKHcewYx3Gz9u_Dn1b_sU77r5meRSlFySibvF182tqSVyjtTqOuue6t6pDz1RWP6W580szZKrms1eEmRSb_RIpzZGgVfKNduKoAx7uHGW2dKivEC1nq0UCSXHoKm4H1Q_gHPfw/s1600/yellow-light.jpeg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Yellow!  Don't you just think every time you see this color that "warning, you need to complete data entry to avoid killing someone?  Who needs WORDS?</td></tr></tbody></table> It's all so CLEAR!!!! <blockquote class="tr_bq">... Providers can misinterpret this field to mean the length of time they want the order to infuse over, when the system intent for that field is to be the system-calculated length of time until the next bag supply will need to be sent to maintain the continuous infusion.  </blockquote> See how simple!!!!   Isn't it OBVIOUS!!!! <blockquote class="tr_bq"> The completed fields turn white. Cerner does not have an intermittent fluid administration order [who the hell needs that, says Cerner and the hospital executives who bought this package for the PICU!! Never a need for that in ICU's!! - ed] so providers are expected to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, they may inadvertently order a higher rate than intended.</blockquote> Ha ha!  Those silly doctors can't even figure out a simple thing like that!!  What stooges they are!! <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/AVvXsEhT3rcoW8Gw85QLLLUqEtmVvyIqCGPmTDBoLqWmwLa5zC0a-4ORhr7iLkFrSZBeA02TCfVLzn5pqH7WxtywG0kyZt54ExddyyuDE_UjALynE545TJIgb5SaosZIC6vFUiC9jt6yhyphenhyphenPpqf5i/s1600/three-stooges.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="156" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhT3rcoW8Gw85QLLLUqEtmVvyIqCGPmTDBoLqWmwLa5zC0a-4ORhr7iLkFrSZBeA02TCfVLzn5pqH7WxtywG0kyZt54ExddyyuDE_UjALynE545TJIgb5SaosZIC6vFUiC9jt6yhyphenhyphenPpqf5i/s1600/three-stooges.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">NYUK NYUK NYUK ... Hey Moe!!  Those silly doctors and nurses cannot understand the simple fact that Cerner does not have an intermittent fluid administration order so providers are expected to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, they may inadvertently order a higher rate than intended.  </td></tr></tbody></table> See how much FUN health IT problems can be?  After all, in this ANECDOTAL case, all that happened was: <blockquote class="tr_bq">The device(s) may have caused or contributed to: Potential for patient harm, Serious Injury </blockquote> But nobody died of this particular problem (that we know of), so this technology is SAFE!!!! <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgNHrlprFiMwMg8w-uhH23RA1KLiJ7O5qDqdj547Mc40zYY4nDhmNEqZ_d5163YRafaQ34simadB6lLrldXAktiWpOZNGbn2kctTetmpIBNH6FhjjBEO7ZIqwQm9Lgo68p7sjlS1Z5FofgT/s1600/Happy-Mothers-Day.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="268" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgNHrlprFiMwMg8w-uhH23RA1KLiJ7O5qDqdj547Mc40zYY4nDhmNEqZ_d5163YRafaQ34simadB6lLrldXAktiWpOZNGbn2kctTetmpIBNH6FhjjBEO7ZIqwQm9Lgo68p7sjlS1Z5FofgT/s1600/Happy-Mothers-Day.png" width="320" /></a></div> Happy mother's day!!! -------------------- Additional not-so-funny thought:  depending on brown, yellow etc. instead of clear, written alerts/warnings, plus the fact that the system likely "knew" the weight of the child and should have alerted that the infusion of a liter was a very dangerous thing, reflect Bad Health IT on its face: <blockquote class="tr_bq">Bad Health IT ("BHIT") is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.   </blockquote> Had I been a pre-marketing tester of this system working for FDA, those fluid-ordering characteristics would have been changed before the system would have been released to market. Oh, wait ... there is no premarketing testing process for health IT, and FDA, via advice from the FDASIA committees as in the linked FDA-related post above, writes that none is really needed. And who wants to damage TRUE INNOVATIONS like this - turning something that takes 5 seconds for a clinician to write, "D5W, 20 ml/hr x 6 hrs" (meaning dextrose 5% in water, 20 milliliters per hour for 6 hours) into a cryptic and muddled exercise with tabs, colors and numerous caveats - via regulation? -- SS

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

[Note to the humorless: this post is satirical and sardonic to make a very serious point about the perversity of downplaying/ignoring heal...

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In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania (<a href="https://www.ecri.org/About/Pages/default.aspx">https://www.ecri.org/About/Pages/default.aspx</a>) has had health IT as among the "Top Ten Healthcare Technology Risks" for several years running.  Search this blog on "ECRI" for mention of those reports. Just off the press, though, is ECRI's "Top Ten patient safety concerns for 2014".  The PDF report is available at <a href="https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf">https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf</a>. Health IT is number one, perhaps as a result of the ECRI Deep Dive study of Health IT risk with its hair-raising numbers of 171 "IT incidents", 8 resultant injuries, and 3 possible deaths in 36 hospitals in just 9 weeks (<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>). From the new report: CONCERN #1: Data integrity failures with health information technology systems <div>At page 7:</div><div> <div style="font-family: serif; margin-left: 40px;">With the federal government offering financial incentives for hospitals and physician practices to adopt EHR systems, use of these systems more than tripled from 2009 through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice president, technology evaluation and safety, ECRI Institute. “They are managing a lot of information, and it’s easy to get something wrong” if the systems are not designed and implemented well. While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions, the presence of incorrect data can lead to incorrect treatment, potentially leading to patient harm.</div> <div style="font-family: serif; margin-left: 40px;">For example, the integrity of data in health IT systems can be compromised from any of the following: data entry errors, missing data or delayed data delivery, inappropriate use of default values, copying and pasting older information into a new report, use of both paper and electronic systems for patient care, and patient/data association errors (i.e., patient data from a medical device is mistakenly associated with another patient’s record). Key steps in safeguarding the integrity of electronic patient data include the following:</div><div dir="ltr" style="font-family: serif; font-size: 16.6667px;"> <div style="font-family: serif; margin-left: 40px;"> </div><div style="font-family: serif; margin-left: 40px;">x  Assessing the clinical workflow to understand how the data is, or will be, used by frontline staff  x  Testing the system and the associated interfaces, preferably in a simulated setting, to verify that the system is functioning as intended x  Providing sufficient user training and support x  Establishing a mechanism for users to report problems as they are discovered </div></div></div>In the Bizarro world in which we find ourselves in 2014, however: <ul><li>FDA has decided that healthcare information technology systems "for health information and data management" (I quote) are of "sufficiently low risk", even if they "meet the statutory requirements as medical devices" and thus fall under the Food, Drug & Cosmetic Act, to not require FDA oversight, and even though FDA admits they really do not and cannot know the true level of risks (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>).  </li></ul>(Got that?) While: <ul><li>Regulation of E-cigarettes is a National Priority of the Highest Importance due to Their Possible Deadly Dangers (<a href="http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html">http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html</a>).</li></ul>The E-cigarette focus is For The Children, no doubt. <ul><li>Except for children such as these, one might conclude:  <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a>.</li></ul> <ul> </ul> <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/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Bizarro World (<a href="http://en.wikipedia.org/wiki/Bizarro_World">http://en.wikipedia.org/wiki/Bizarro_World</a>).</td></tr></tbody></table> Note that ECRI Concerns #2 and #3 also may involve electronic medical records systems. CONCERN #2: Poor Care Coordination with Patient’s Next Level of Care (page 8): <blockquote>... Electronic health records (EHRs) can facilitate communication about a patient’s care among providers, but organizations must establish procedures that address accessing, reviewing, and acting on the findings in those records. For example, what happens if a provider who is viewing a patient’s record discovers that results of tests ordered by another provider have not been acted upon? EHRs could become a barrier “if physicians are second-guessing one another,” says Possanza. Organizations might find it helpful to develop a policy specifying procedures for a provider who finds an abnormal laboratory or pathology result with no indication that the abnormal result was acted upon.</blockquote><ul></ul> CONCERN #3: Test Results Reporting Errors (page 10): <blockquote class="tr_bq">... Callahan observes that breakdowns in test results reporting, particularly in physician practices, typically have one of three causes or a combination of them: (1) technology limitations, such as an inadequate interface between an EHR system and a laboratory system that provides the results electronically; (2) provider-to-provider communication gaps, such as those that occur when no backup plan is in place to designate a provider to review test results for another provider who is unavailable or on vacation; and (3) staffing and training failures, such as requiring a staff member to periodically check an EHR system for test results but not informing the person of what to expect in terms of the volume of test results typically reported to the practice. As more healthcare organizations adopt EHR systems, Callahan warns against being lulled into thinking the systems are a panacea and can prevent test reporting failures. “It’s another tool,” she says. “It won’t improve test results reporting if it’s not used correctly.”</blockquote> I was involved as consultant in a related scenario, in a case that settled out of court, where an ordered lab test was never performed (probably due to an EHR-lab interface failure!) and automatically "expired" in the EHR after a year.  However, no subsequent provider acted upon the expired order, with disastrous results. -- SS

In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania ( https://www.ecri.org/About/Pages/default.aspx ) has had health IT as among the "Top Ten Healthcare...

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