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“No” is Often in Your Best Interest

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Posted on Sep 9, 2015 by Bill Haughton

Posted under Medication Safety

“No” is Often in Your Best Interest

When designing our Intelliguard® Kit and Tray Management System, we set out to create a reliable technical solution and workflow processes that were both safe and user friendly.

I was reading an interesting article recently about the relationships between supplier and customer and one particular section caught my eye - a question that we at MEPS® have had to address on several occasions over the last year: ‘When should you walk away from a sale?’ 

Listed within the expected list of reasons (financial status of the client, etc.) was one very interesting point:  ‘When the prospect does not share your Immutable Laws (values) and express beliefs or take actions that go against your values’. 

Mike Michalowicz describes Immutable Laws as “a blend of ethics, core values and self-assigned law, all wrapped up into one. They are the rules we have defined for ourselves, almost subconsciously, on what is right and what is wrong. What is acceptable and what is not.”   He further writes “Immutable Laws trigger a nagging voice in your head that punishes you when you break them. They also give you the reassuring ‘at-a-boy’ when you follow their guidance. They cause you to judge yourself. They keep you on track.  It is your soul that guides you. It is the soul of your business.”

When RFID-enabled kit and tray management systems were in initial design phases in 2010/2011, a Food and Drug Administration (FDA) Compliance Policy Guide (CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs) had been published representing the FDA's current thinking on the topic of RFID programs for drugs.  The CPG was originally issued in November, 2004; revised in June 2013 and expired 12/31/2014.

In addressing RFID tagging policy, the FDA guidelines note:  Information will be written to the tag at the time that the tag is manufactured (e.g., "read only" tags), after the tag is manufactured but before it is affixed to a drug's container (e.g., "read-write tags"), or after the tag is affixed to a drug's container.4

From the perspective of our advisory board and product management team’s research, the footnote to this guideline was key to the safety of tagging medications for use in procedural and emergency kits and trays and served as a key point in our guiding product design principles:

4 Writing to a tag before it is affixed to a container increases the risk of product mix-ups. We suggest that industry and other interested parties explore the feasibility of writing to the tag after it is affixed to the container.

Safety is and has always been one of the Immutable Law’s at MEPS®.  From the start, we recognized it was critical to develop an RFID solution that would not introduce new risks to the processes we sought to improve.   In addition to the FDA Compliance Policy Guide, the American Society of Health-System Pharmacists (ASHP) identifies relabeling as one of the significant points of error within the pharmaceutical chain of command.  Sadly, there’s no better example of the life-threatening risk of product mix up than the case of Loretta Macpherson: Hospital medication error kills patient in Oregon   Macpherson, 65, died shortly after she was given a paralyzing agent typically used during surgeries instead of an anti-seizure medication.

Results of Medical Error Investigation:  In the ensuing investigation, it was discovered that the label on the bag was that for the drug that had been ordered, the staff (at the ER) had no way of knowing the drug that was actually in the bag was not the one that was ordered.  "It is a human error," Robert Gomes, CEO at St. Charles Bend and Redmond, told reporters at a news conference. 

Here are the key points of the root cause analysis detailing how mislabeling lead to the medication error:

1- The label that printed from the system and was placed on the IV bag was for the drug that was ordered – fosphenytoin – although what was actually in the bag was rocuronium.

2- The vials of rocuronium and the IV bag that was labeled “fosphenytoin” were reviewed without the error being noticed.

3- The IV bag was scanned in the Emergency Department, but because the label on the bag was for the drug that had been ordered, the system did not know to sound an alarm.

4- The bedside caregiving staff had no way of knowing the medication within the bag was not what had been ordered.

 

Although the Macpherson example did not involve secondary RFID labeling directly, it does highlight how human error can easily be the cause of a product mix up.  In this case, the wrong drug was filled in the IV bag but labeled with what was ordered.   In the case of a secondary RFID label printed before it is affixed to a container, the same risk of human error and product mix-up exists – applying the wrong label to a vial.  

And, the problem is actually further exacerbated and more closely akin to the MacPherson case if human readable information is printed on the secondary RFID label.  In that case, not only is the RFID label affixed to the wrong container (an inventory error), but now the printed RFID label indicates the wrong drug (a potential medication administration error). 

When designing our Intelliguard® Kit and Tray Management System, we set out to create a reliable technical solution and workflow processes that were both safe and user friendly.  How RFID Smart Tags would be encoded and affixed to medications was a key consideration.  We knew best practice was to encode RFID tags only after they were affixed to medication vials, and we knew that printing duplicate, human readable information on secondary labels (in this case, the RFID labels) was a clinical safety risk.  

After extensive research and development, we developed techniques utilizing patented, patent pending and exclusive intellectual property to support our Smart Tag Processing™ method, which uses Safe Tag Encoding™ and Smart Multi-Batch Approval™ workflows to encode RFID Smart Tags and approve medications.  These processes allow us to avert the risk of product mix up and medication error at administration in 2 ways: 

1- Safe Tag Encoding™ happens only after the RFID Smart Tag is affixed to the container, and

2- There is no human readable information on our RFID Smart Tag that provides any drug data

By design, our RFID Smart Tag does not include any drug information that would be discernable to a clinician and therefore, can never be the cause of a medication error at administration.  Clinicians must continue to rely on the manufacturer’s label to determine the contents of the medication package. 

Sure we could print drug data on our RFID Smart Tag (Zebra printers do a fine job of that) and sure we could offer both printed and a non-printed options just to make sure we get every sale we can.  But while insight from customers has been, and will remain, a key part of our product enhancement strategy, we have designed certain resolute processes into our product and this is one that we don’t compromise.  No customer can be more important than what we consider the safest approach – especially when patients are at risk.   

This can sometimes cause a misperception for clients who have been told that the only way to assure our RFID Smart Tag is affixed to the correct medication vial is to create a secondary RFID label printed with drug information to enable a visual match.   In fact, we have been asked on several occasions about adding drug information to the RFID Smart Tags for our Intelliguard® Kit and Tray Management System.  The answer is always a resounding ‘no’. 

You can actually take a look at the two primary RFID Tag Processing Workflows side-by-side here and judge for yourself:  http://www.mepsrealtime.com/intelliguard-compare/#compare

 

While we believe the evidence supports our position regarding relabeling, we respect a client’s choice to disagree.  If a secondary printed RFID label is a “showstopper” for them, we’ll graciously decline the opportunity.

As the Vice President of Sales for a commercial company, my assignment is to sell our products and solutions - to close as much business as we can every month, every year.  If a client demands a product feature that we identify is not best practice, we can point them to the evidence, but ultimately, we don’t have any control on how they choose to proceed.  Thankfully, I work for a company that agrees that a feature request that goes against our Immutable Laws is an opportunity we will always politely decline – even if it means we don’t get the business.

In this case, we believe the risk of patient safety is just too great, and that’s a risk we’re not willing to take – for the sake of Mrs. Macpherson and all other patients like her.

Directors of Pharmacy, medication safety leaders and other hospital administrators, We would love to hear what you think.  Are we missing something here? Is our stance on this issue just too rigid?   If you’d like to weigh in, please email me directly at bhaughton@mepsrealtime.com

 Bill Haughton, Vice President of Sales

Tags: Medication Safety RFID Tag

 
 

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