Some time ago, I'd written an eight part (later expanded to nine part) series on health IT mission hostile user interfaces and experiences.
(Note: Part 1 of this series is here, part 2 is here, part 3 is here, part 4 is here, part 5 is here, part 6 is here, part 7 is here, and part 8 is here. April 2011 addendum: a post that can be considered part 9 is here.)
Here is an addendum, part 10, from the FDA Maude (Manufacturer and User Facility Device Experience) Database. I do not know who wrote it or where it was from. It was received by FDA as indicated on 3 April 2011:
FDA MAUDE REPORTI will let the FDA report speak for itself, with only one question:
Event Type Other
I am writing to report a problem in the design of the cerner powerchart computer provider order entry (cpoe) product. As i will describe below, these design flaws are largely responsible for approximately 100 medication errors per day in our 240 bed hosp. The (b)(6) hosp in (b)(6) is a 240 bed teaching hosp. We are owned by the (b)(6). We have to be one of the only hospitals in the country to fully implement cpoe with two entirely different electronic medical records (emr).
In 2007, we completed a comprehensive cpoe implementation using idx 3. 1 (which was later purchased by general electric). Our self-reported medication error rate was <2 error reports per day. In (b)(6) of 2010, we transitioned our emr to cerner millennium - powerchart (b)(4). This implementation was done as a first step to converge onto a single electronic medical record across the (b)(6) enterprise.
Despite extensive nursing informatics support (approx. 7000 hrs per month for the first six months after implementation), our error rate went from approx. 176 medication errors per day one month after implementation to approx. 100 medication errors per day currently. It has been stable at this level for at least the past 3 months. Many of these errors involve high risk medications (e. G. Heparin, morphine). In order to understand the etiology of the errors, i need to explain how cerner processes cpoe orders.
With cerner, orders are grouped into plans ("powerplans"). These plans can include sub-plans ("phases") and sub-sub-plans ("sub phases"). A typical orders display screen appears as follows: (b)(4). Under the plans is an order tab which displays other orders.
This design allows two distinct sources of error.
First, there is no consistent way to view orders for medications. A medication order can display either in a plan, sub-plan, or under the orders tab. In order to find a given medication, cerner mandates that you click through each and every plan. This facilitates duplication of both medication and non-medication orders (there is a medication checker which is so poorly designed and does little to aid the pharmacists in detecting duplicate medications).
Second and more dangerous, high risk intravenous medications can be run either inside or outside of the plan. Cerner programming [i.e., the user interface design -ed.] does not keep high risk medications in a consistent spot. It is very easy to stop monitoring for heparin (which is included in the heparin plan) while continuing the heparin (which is outside the plan) or vice-versa.
As you can probably guess, we formed multiple interdisciplinary teams to address these deficiencies. [Workarounds - ed.]
I was the lead physician on the orders team. Although we were unable to reduce the error rate, it is not close to an acceptable level. Again, i believe this is because of the design of the cerner product which is why i chose to bring this to your attention. With issues this complex, i am a firm believer that "seeing is believing. " if desired, i would be happy to arrange a web conference to demonstrate my concerns.
Brand Name CERNER POWERCHART COMPUTER
Type of Device NONE
Manufacturer (Section F) CERNER
Manufacturer (Section D) CERNER
Device Event Key 2081342
MDR Report Key 2045867
Event Key 1942844
Device Sequence Number 1
Product Code LNX
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 04/03/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?
Page Last Updated: 11/30/2011
When will the designers, developers, purchasers and implementers of medical devices like this start to be held criminally liable for patient injuries that occur from the risk these devices pose to patient safety?
criminal negligence - (law) recklessly acting without reasonable caution and putting another person at risk of injury or death (or failing to do something with the same consequences)
It's not as if the issues related to good user interface design are a mystery, nor have those issues been a mystery for at least a few decades.
An EHR design as described, if accurate, while perhaps "nifty" in some way from the computer-techie perspective, would require significant recklessness to design and to actually implement in a life-critical setting.
Those who try to point out these issues internally are sometimes subject to retaliation (for not being a "team player", of course, which in today's parlance means someone who is silent, or silenced, or a co-conspirator regarding managerial mediocrity, malfeasance, or madness). An example is here. We at Healthcare Renewal simply refuse membership on that team.
(Did I mention this deterministic miracle-making technology is slated via the HITECH Act for rollout in the U.S., unless the medical professional or organization is willing to accept progressive cuts to their Medicare reimbursement?)