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Safety Issues Remain Long After EMR Rollout

Posted on June 24, 2014 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @annezieger on Twitter.

The following is a bit depressing, but shouldn’t come as a surprise. A new study published in the Journal of the American Medical Informatics Association has concluded that patient safety issues relate to EMR rollouts continue long after the EMR has been implemented, according to a report in iHealthBeat.

Now, it’s worth noting that the study focused solely on the Veterans Health Administration’s EMR, which doubtless has quirks of its own. That being said, the analysis is worth a look.

To do the study, researchers used the Veterans Health Administration’s Informatics Patient Safety Office, which has tracked EMR safety issues since the VA’s EMR was implemented in 1999.  Researchers chose 100 closed patient safety investigations related to the EMR that took place between August 2009 and May 2013, which covered 344 incidents.

Researchers analyzed not only safety problems related to EMR technology, but also human operational factors such as workflow demands, organizational guidelines and user behavior, according to a BMJ release.

After reviewing the data, researchers found that 74 events related to safety problems with EMR technology, including false alarms, computer glitches and system failures. They also discovered problems with “hidden dependencies,” situation which a change in one part of the EMR system inadvertently changed important aspects in another part of the system.

The data also suggested that 25 other events were related to the unsafe use of technology, including mistakes in interpreting screens or human input errors.

All told, 70% of the investigations had found at least two reasons for each problem.

Commonly found safety issues included data transmission between different parts of the EMR system, problems related to software upgrades and EMR information display issues (the most commonly identified  problem), iHealthBeat noted.

After digging into this data, researchers recommended that healthcare organizations should build “a robust infrastructure to monitor and learn from” EMRs, because EMR-related safety concerns have complicated social and technical origins. They stressed that this infrastructure is valuable not only for providers with newly installed EMRs, but also for those with EMRs said that in place for a while, as both convey significant safety concerns.

They concede, however, that building such an infrastructure could prove quite difficult at this time, with organizations struggling with meaningful use compliance and the transition from ICD-9 to ICD-10.

However, the takeaway from this is that providers probably need to put safety monitoring — for both human and technical factors — closer to the top of their list of concerns. It stands to reason that both newly-installed and mature EMR implementations should face points of failure such as those described in the study, and they should not be ignored. (In the meantime, here’s one research effort going on which might be worth exploring.)

HHS Releases Health IT Safety Plan

Posted on July 3, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @annezieger on Twitter.

HHS has released a plan designed to strengthen health IT-related patient safety efforts, offering “specific and tangible” advice for stakeholders across the healthcare industry spectrum as to how they can participate.

The Health IT Patient Safety Action and Surveillance Plan builds on an earlier effort by the Institute of Medicine which examined how to make health IT-assisted care safer.  This Plan breaks down further how key health system players such as patients, providers, technology companies and healthcare safety oversight bodies can take appropriate steps to improve health IT safety.

The Plan also spells out the steps HHS believes it should take to make sure knowledge of best practices in health IT are leveraged to make a difference.  The following offers a few examples of what the agency expects to do:

Use Meaningful Use and the National Quality Strategy to advance health IT safety:  HHS plans to use knowledge of health IT safety risks and trends, and focus that knowledge on clinical areas where there’s already safety issues (such as surgical site infections). ONC, for its part, is going to establish a public-private mechanism for developing health IT-related patient safety measures and targets. And HHS also plans to incorporate these improvement priorities into the Meaningful Use program.

Incorporate safety into certification criteria for health IT products:  ONC expects to update its certification criteria for health IT products — including EMRs — to address safety concerns.  ONC  has already incorporated safety principles for software and design principles in its 2014 final rule, but just two such requirements  Expect more to come.

Support R&D of testing, user tools, and best practices related to health IT safety:   HHS and its federal partners are supporting R&D of evidence-based tools and interventions for health IT developers, implementers, clinical staff and PSOs.  This year, ONC will begin disseminating a new class of health IT safety tools designed to help health IT implementers and users assess patient safety and leverage the latest applied knowledge of health IT safety.

*  Incorporate health IT safety into education and training for healthcare pros:  Through its Workforce Development Program, ONC awarded grants to universities and community colleges to develop health IT programs. This effort will continue, but will add up-to-the-minute information on health IT-related safety to the schools’ programs.

*  Investigate and take corrective action addressing serious adverse events or hazards involving health IT:  HHS plans to work with private sector organizations which have the capacity to address such events or hazards, including The Joint Commission.

This is a meaty report, and I’ve barely skimmed the surface of what it has to say. I recommend you review it yourself. But if you’re looking for a quick takeaway, just know that HHS is entering a new era with its focus on health IT safety, and if the agency gets half of what it plans done, there are likely to be some serious ripple effects.

EMR Rollouts: Are They Ethical?

Posted on February 28, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @annezieger on Twitter.

Here’s something you should really see for yourself. Over at Dr. Wes’s blog, the good doctor has written a long and thoughtful post on whether rolling out EMRs to patients actually constitutes medical experimentation without patient consent.

I thought readers who don’t have time to read all of Dr. Wes’s carefully-structured argument might be interested in hearing a bit of what he has to say, as I believe his conclusions are important. Here’s some of his assertions:

*  EMR costs are ultimately passed along to patients, whether they like it or not. And with insurance premiums climbing as much as 20 percent in 2013, patients are already having serious trouble paying for care.

* With EMRs still not interoperable in most cases, the efficiencies we’d hoped for largely aren’t showing up yet.  In fact, EMRs are adding to inefficiencies as doctors struggle to add needless data to electronic charts.

* With health data breeches continuing and errors growing, EMRs may be part of the problem and not the solution.

So, he suggests that we take a pause and ask ourselves some tough questions:

Does the ends of presumed cost savings to our national health care system justify the deployment of poorly integrated, difficult-to-use systems? Are patients being subjected to new risks heretofore never considered with the adoption of this technology? Could a tiny programming error occur that negatively impacts not just one patient, but millions? If so, what are the safeguards in place to prevent catastrophic error? Who will be responsible? Who is the oversight body that assures the guiding principles of the Belmont Report (respect for persons, beneficence and justice) with respect to EMR deployment are followed? The Secretary of the Department of Health and Human Services or a more nebulous body like Congress?

Dr. Wes, in summary, wonders whether it’s unethical to roll out EMRs en masse given the still-unanswered questions about their benefits, their safety and their efficiency. And I think he’s asked a question worth answering. How about you?

ONC Plan Focuses On Health IT Safety

Posted on January 2, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @annezieger on Twitter.

The ONC has decided that it’s time to move health IT safety up to the next level, proposing a plan that would standardize the way health IT safety incidents are reported and make it easier to report straight from an EMR. And brace yourselves, vendors: this could include changing the EMR certification process to include the ability to make such reports easily.

The agency’s Health IT Patient Safety Action and Surveillance Plan is designed to strengthen patient safety efforts, including patients, providers, technology companies and healthcare safety oversight bodies in the mix. The idea, not surprisingly, is to use health IT to make care safer.

The ONC’s key objectives include the following:

*  Making it easier for clinicians to report patient safety events and risks using EMRs

Right now, it’s not exactly easy for clinicians to create a safety event report when something goes wrong in their use of an EMR, and the data they do sometimes produce isn’t easy to work with or compile.  ONC is proposing using certification criteria to make sure that whenever possible, EMRs make it easy to report safety events using the Agency for Healthcare Research and Quality’s standardized Common Formats.

*  Getting health IT developers to support patient safety and safety reporting

Within 12 months, the ONC plans to create a code of conduct — working with professional groups and health IT developers — which will hold developers accountable for:

— Creating usable, safe designs for products and adverse event reporting
— Working with a Patient Safety Organization to report, aggregate and analyze health IT related safety events
—  Scrapping practices that discourage provider reporting of safety events, such as limits in nondisclosure clauses and intellectual property protections
—  Participating in efforts to compare user experiences across different EMR systems

There’s plenty more to consider in this report, but I’ll leave you with these details in the hope that you’ll read it yourself.  As you’ll see in the introduction, you have until February 4th to comment on ONC’s plans. I hope plenty of readers do — this is important stuff.

NIST’s EHR Usability Conference Breaks Both Old Ground and New Focuses on EMR Patient Safety Protocol

Posted on June 14, 2012 I Written By

When Carl Bergman isn't rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of EHRSelector.com, a free service for matching users and EHRs. For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manger doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst.

Regular reader, Carl Bergman from EHR Selector, attended the recent NIST EMR Usability Conference and sent over the following guest post on what was said. Thanks Carl for sharing your experience with us.

A year ago last June I attended NIST’s (National Institute of Standards and Technology) conference on EMR/EHRs usability. [See Carl's post on the NIST EHR Usability Conference from 2011.] It was a mixed bag. There were several excellent presentations on the fundamentals of usability, how to analyze an EMR and where the field was headed. Unfortunately, NIST’s staff took a narrow view confining their work to EMR error conditions and assiduously avoiding interface, workflow and clinical setting issues. It was odd that an agency that prided itself on redesigning nuclear control rooms after Three Mile Island or the design of airplane cockpits would ignore EMR user interfaces.

New Approach: New Protocol

At this year’s conference at NIST headquarters in Gaithersburg, MD, the past was not prolog. Last week’s conference focus was on a comprehensive EMR usability protocol, NISTIR 7804, that NIST produced last February. (For a good synopsis, see Katherine Rourke’s Design Errors That Cause Patient Harm per NIST.) NIST’s staff pulled together a notable group of speakers on patient safety in general and implementing the protocol in particular. (NIST is posting the presentations here.)

The protocol, designed to review an EMR, is not a trivial undertaking since it has about 180 line item questions. It asks, for example, if the EMR:

  • Keeps patient identities distinct from each other? That is, does the system prevent one record from writing over another or erroneously sharing data elements?
  • Lays out pages in a consistent manner using color, icons and links identically?
  • Uses measurements consistently? That is, if weight is entered in pounds and ounces in one place, do they show that way in other places?
  • Displays fields fully rather than being truncated?
  • Sorts logically based on the subject?
  • Show dosages, etc., with all needed information on the page?
  • Displays multipage entries or lookups with proper navigation choices?
  • Has error messages that state what is wrong and how to cure the problem?
  • Accommodates different levels of user knowledge? That is, does it have extended help for novice users, refresher information for occasional users and short cuts for experienced users?

Developers Present in Force

If NIST’s major intent was to get developer attention, they succeeded. Of the hundred or so attendees, about 20 percent were from major systems. 3m, Allscripts, Athenahealth, Centricity, McKesson, NextGen, etc., each had one or more representatives present. Others present included Kaiser, HIMSS, Medstar, First Choice, ACP, Columbia, etc.

Unfortunately, there is no way to know developer reaction to the protocol. The conference had no comment session. I don’t know if this was by design or if time just ran out. NIST staff did indicate that next year the conference would be two days rather than one. However, a year is a long time to wait for reactions. This is especially pertinent since NIST is not a regulatory agency. Its protocols are strictly voluntary and depend on vendor acceptance.

What NIST did do is offer several presentations that emphasized how fragile patient safety can be in an HIT world. One breakout session used an actual, unnamed product’s screen that had dozens of misleading or ambiguous fields. For example, the screen’s fields cut off drug names, used red to indicate several different findings and used a pop up that blocked a view of a pertinent entry.

In another more broadly based patient safety presentation, University of Pennsylvania’s voluble Ross Koppel drove home how common elements in EMRs such as blood pressure – he’s found 40 different ways to show it so far – are subject to many formats for capture and display. Moreover, if you think EMRs have problems, Koppel shows how bar codes and work arounds can play havoc with workflow and patient safety.

Wanted: One Good Policy Compass

For those of us possessed of an EMR design demon, it was both a good chance to wonder out loud just what it all meant and where, if anywhere, things were headed. Sadly, the most common answer was who knows? There were some common points:

  • It’s better to have NIST’s protocol than not.
  • You can forget the FDA playing a bigger role. It’s under funded and over worked.
  • HIMSS will wait for the industry and the industry has shown no hurry.
  • EMR adverse incident reporting would be great, but who would do it and how open would it be?

In short, if you’re shopping for an EMR, regardless of your size, don’t count on anyone handing you a usability report on an EMR anytime soon. Moreover, don’t try to run NIST’s protocol on your own unless you have full access to the proposed EMR, lots of time on your hands and a good grasp of the protocols details.

There are some things you can do. You can ask potential vendors questions such as these:

  • Have they run the NIST protocol and what did they do as a result?
  • If not NIST, do they have a written usability protocol and, if so, can you see it? How have they implemented it?
  • Have they tested their EMR’s usability with outside, independent users? What were the results?
  • Have they used any interface designers?
  • What usability changes do they plan?

There is no guarantee that you’ll get a great product, but it could mean that you get one that doesn’t bite your patients or you.

101 Tips to Make Your EMR and EHR More Useful – EHR Tips 16-20

Posted on December 13, 2011 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 15 blogs containing almost 6000 articles with John having written over 3000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 13 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Time for the next entry covering Shawn Riley’s list of 101 Tips to Make your EMR and EHR More Useful. I met someone at a conference who commented that they liked this series of posts. I hope you’re all enjoying the series as well.

20 Data collaboration is key to patient safety
I think this tip might need to be worded, “Data collaboration should be key to patient safety.” Unfortunately, it’s a mostly unrealized dream at this point. You might even be able to say that data collaboration will be key to patient safety. There really are amazing use cases where data collaboration can improve the care patients receive. It’s a sad state of affairs that so many of the major EHR companies are dead set on protecting their walled gardens. One has even gone so far as to say that patient safety is in danger with multiple systems. Certainly there are some risks associated with multiple systems, but the benefits far outweigh the risks. In fact, patient safety is at stake thanks to those who won’t participate in healthcare data collaboration.

19 Know how customizable the clinical work flows are!
This is a good tip when doing your EMR selection. It’s incredibly valuable to understand how the EMR handles clinical workflows and how well those workflows fit into your established clinical workflows. I’m a proponent of doing the best you can to use established workflows when implementing an EHR. Then, over time adjusting those workflows as needed to gain more efficiency.

18 How easy is it to customize the system overall?
I’d take this EHR tip from a couple angles. First, is how easily can you customize the EMR system. Yes, some of it could be the EMR workflows that I talked about in EMR Tip #19 above, but it could be a whole set of other options (billing, scheduling, messaging, etc). The second part of this suggestion relates to how well this EHR will adapt to the constantly changing clinical environment. Will they be able to handle ICD-10 without too much pain for you? Will you be able to make it work in an ACO environment? Healthcare is constantly changing and so you want to make sure your EHR can be customized to fit your changing needs.

17 Know work flow can be hard coded to ensure compliance.
There are times when hard coding the workflow is incredibly valuable. Certainly this will frustrate some providers, but if done correctly most will understand the need to hard code the workflow to ensure compliance. It’s a fine line to walk, but there are plenty of instances where hard coded workflows can do wonders to improve the care you provide.

16 Ensure easy access to the system via multiple platforms.
As much as providers might not like checking in on the EMR remotely, it’s often absolutely necessary. So, it’s important to ensure that your EMR is available on every medium possible. Can it be connected to remotely? Does it work on the latest devices? Yes, the iPad has a huge portion of the physician market share right now, but we’ll see how long that lasts. Every year a new device comes out and you’ll want an EMR vendor that’s keeping an eye on this movement and making the EMR available on the best technology.

If you want to see my analysis of the other 101 EMR and EHR tips, I’ll be updating this page with my 101 EMR and EHR tips analysis. So, click on that link to see the other EMR tips.

101 Tips to Make Your EMR and EHR More Useful – EHR Tips 36-40

Posted on September 27, 2011 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 15 blogs containing almost 6000 articles with John having written over 3000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 13 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Time for the next entry covering Shawn Riley’s list of 101 Tips to Make your EMR and EHR More Useful. I hope you’re enjoying the series.

40. Do NOT let the finance department drive the EMR choice or deployment
I’m far too much of a physician advocate to even imagine a finance department driving the EMR choice and deployment plan. Ok, I understand that it happens, but it’s a travesty when it does. Considering the finance department will almost never use the system, it should make sense to everyone to have the users of the system help drive the EMR choice and deployment. After all, they will have to use the system once deployed.

Let’s not confuse what I’m saying. I’m not saying that finance shouldn’t be involved in the EMR choice. I’m not saying that finance can’t provide some great insights and an outside perspective. I also am not saying that users of the EMR should hold the hospital hostage with crazy demands that could never be met. It’s definitely a balance, but focus on the users of the EMR will lead to happy results.

39. Ensure work flow can be hard coded when necessary, and not hard coded when necessary
Related to this EHR tip is understanding when the EHR company has chosen to hard code certain fields or work flows. You’ll be surprised how many EHR have hard coded work flows with no way to change them. In some cases, that’s fine and even beneficial. However, in many other cases, it could really cause you pain in dealing with their hard coded work flows.

Realize which parts of the EHR can be changed/modified and which ones you’re stuck with (at least until the next release..or the next release….or the next release…).

38. You can move to population based medicine
You’re brave to do population based medicine on paper. Computers are great at crunching and displaying the data for this.

37. Safety is created by design
Just because you use an EHR doesn’t mean you don’t need great procedures that ensure safety. Sure, EHRs have some things built in to help with safety, but more often than not it’s a mixture of EHR functionality and design that results in safety. Don’t throw out all your principles of safety when you implement your EHR.

36. Medication Reconciliation should be a simple process
I’m not sure we’ve hit the holy grail of medication reconciliation in an EHR yet, but we’re getting closer. It’s worth the time to make this happen and will likely be required in the future.

If you want to see my analysis of the other 101 EMR and EHR tips, I’ll be updating this page with my 101 EMR and EHR tips analysis. So, click on that link to see the other EMR tips.

EMRs And Malpractice Liability: Some Questions

Posted on February 19, 2011 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @annezieger on Twitter.

If things go as planned,  EMRs will prevent a multitude of medical errors from happening.  They’ll make sure patients don’t get the wrong drug or dose, help avoid interactions, alert clinical staff to key issues that emerge in real time from monitoring devices and more.  The sky is pretty much the limit here.

The thing is, who will be judged responsible when something goes wrong — and it’s the EMR’s “fault”?  For example:

*  What if the EMR somehow sends along data on the wrong patient (a possibility given the massive amount of systems integration issues involved in presenting the data)?  If the patient is harmed, is the doctor liable?

*  If a doctor doesn’t  fully understand the EMR interface, and records that a patient who’s violently allergic to a drug is not, who’s responsible if the patient gets that drug?  The doctor? The intern who relies on that record? The specialist called in to consult on the case and gets bad information? No one?

* What if a physician fully documents a patient’s status, correctly, but somehow the record gets altered by another user — and a patient  is harmed?  Is the second user responsible?  The IT department? The doctor?

These aren’t trivial questions, but I’m betting med mal insurers haven’t a clue how to handle them, much less physicians. I’m fully  expecting the first big malpractice case involving an EMR to surface shortly.   It’ll be a nightmare.