I’ve attended the last two unSUMMITs; Atlanta in 2010 and Louisville in 2011. The conference is focused on barcoding at the point of care. While it’s not as big as the ASHP conferences, it’s full of people that want to learn about barcoding and patient safety. I found it valuable.

Anyway, I received an email yesterday calling for speakers. I presented at the unSUMMIT last year and found it to be quite rewarding. The 50 minutes I spent on stage opened the door for a lot of post presentation discussion with colleagues. If you’ve gone through barcoding implementation at your facility, or are thinking about it, I would encourage you to not only attend the unSUMMIT, but consider presenting as well. It’s only through sharing information that we get better.

Hope to see you there.

mobihealthnews

“This is the best performing barcode scanner for developers who are creating applications incorporating barcode scanning for the Apple iOS,” stated Samantha Chu, data collection product manager at Socket Mobile, in a press release. “There are numerous applications that stand to benefit from barcode scanning in a range of vertical markets, and we believe the CHS 7Xi provides the Apple developer community with a level of control and data integrity that didn’t exist previously.”

I’ve mentioned the CHS Series 7 scanners before. They really are neat little devices; small, quick and accurate.

Another scanner worth mentioning in this category is the Koamtac KDC200. I’ve used the KDC200 and it’s a pretty slick scanner as well.

The presentation focused on the often overlooked things that need to be done following implementation of something like BCMA. Healthcare systems have a bad habit of not providing enough resources, both labor and monetary, to maintain and optimize technology once implemented. I simply suggested five things that healthcare systems could do post-implementation to make sure their BCMA implementation didn’t crumble right before their eyes.

And now that the unSUMMIT presentation has been delivered I am officially retiring from the role of presenter. Unlike some people I know, it takes me a concerted effort and a fair amount of time to put one of these things together, and I just don’t feel like doing it again. Enjoy.

From the unSUMMIT website:

Conventional summits deliver a something-for-everyone survey of the landscape with little or no depth on any given topic. This warp-speed flight provides only a 30,000-foot view of the terrain below. Nurses, pharmacists, and IT professionals return to the trenches of their own hospitals no better equipped to dig in and implement change.

The unSUMMIT is different. It delivers a steadfast focus on barcode point-of-care technology. Attendees are outfitted with practical tools, insight, and inspiration for leading their institutions to carefully select, implement, and harness the quality-improvement power of BPOC systems.

Truly an unconventional convention, The unSUMMIT is designed to get you out of the clouds and into the weeds, where the union of technology and practice can be more easily realized through the shared expertise of your experienced colleagues.

I think most people believe that the unSUMMIT is nothing more than a bunch of people sitting around talking about BCMA, but it actually goes beyond that. Last year I heard presentations on not only bar-coding medications, but integrations of smartpumps into eMARs, the use of RFID tags, how to conduct observational studies and so on.

This year looks to provide a similarly broad scope of information. While reviewing the list of presentations I saw topics on mobile technology, accountability, technology roadmapping, workflow design and of course a lot of stuff on bar-coding medications.

The unSUMMIT begins officially tomorrow morning. I will be presenting on Thursday, April 28 at 2:00pm. I haven’t decided if I’m going to post the presentation here or not. I’ll let you know.

If you’d like to know what’s going on during the conference you can follow the Twitter stream at #unSUM11.

I don’t often see articles that talk about using FMEAs, which is a real shame secondary to their value. So it was a pleasant surprise to see a recent article in Pharmacy Purchasing & Products on the use of an FMEA post BCMA implementation. I’m not familiar with using an FMEA after the fact, but it makes more sense to me now after reading the article.

According to the author, they “had conducted an FMEA prior to initially employing BCMA; however, we never performed any post implementation follow-up on the system.” An all too common occurrence in healthcare, i.e. implement and forget. We did something similar at Kaweah Delta when I worked there, but we referred to the process as a gap analysis rather than calling it an FMEA. Regardless of the verbiage, the results were similar.

The reason cited for the second FMEA was an increase in errors associated with the BCMA system. “Errors were primarily due to unscannable bar codes, mislabeled medications, the wrong medications being dispensed, and most commonly, nursing staff’s failure to scan.” This sounds familiar. The errors cited are simply side effects of the implement-and-forget mentality. Regardless of the system in place, humans inevitably develop bad habits and workarounds. We need to be constantly reminded to do the right thing. Implementation is only a small part of the work involved with any new system. Follow-up, maintenance and optimization is when the real work begins.

And the results of the second FMEA? “Three months after completing the FMEA, the team compared the before and after scan rates. We found significant improvements in the scanning of both the patients and the medications throughout the system. In addition, we have witnessed a culture change: nurses now become anxious if they cannot scan a product.” Not bad.

Read the article, it contains some good information.

Abstract

BACKGROUND: Bar code medication administration (BCMA) technology is gaining acceptance for its ability to prevent medication administration errors. However, studies suggest that improper use of BCMA technology can yield unsatisfactory error prevention and introduction of new potential medication errors.
OBJECTIVE: To evaluate the incidence of high-alert medication BCMA triggers and alert types and discuss the type of nursing and pharmacy workarounds occurring with the use of BCMA technology and the electronic medication administration record (eMAR).
METHODS: Medication scanning and override reports from January 1, 2008, through November 30, 2008, for all adult medical/surgical units were retrospectively evaluated for high-alert medication system triggers, alert types, and override reason documentation. An observational study of nursing workarounds on an adult medicine step-down unit was performed and an analysis of potential pharmacy workarounds affecting BCMA and the eMAR was also conducted.
RESULTS: Seventeen percent of scanned medications triggered an error alert of which 55% were for high-alert medications. Insulin aspart, NPH insulin, hydromorphone, potassium chloride, and morphine were the top 5 high-alert medications that generated alert messages. Clinician override reasons for alerts were documented in only 23% of administrations. Observational studies assessing for nursing workarounds revealed a median of 3 clinician workarounds per administration. Specific nursing workarounds included a failure to scan medications/patient armband and scanning the bar code once the dosage has been removed from the unit-dose packaging. Analysis of pharmacy order entry process workarounds revealed the potential for missed doses, duplicate doses, and doses being scheduled at the wrong time.
CONCLUSIONS: BCMA has the potential to prevent high-alert medication errors by alerting clinicians through alert messages. Nursing and pharmacy workarounds can limit the recognition of optimal safety outcomes and therefore workflow processes must be continually analyzed and restructured to yield the intended full benefits of BCMA technology.

The study described in the article utilized a combination of retrospective analysis and direct observation to identify alert triggers generated by a BCMA system. In addition the study looked at various workarounds utilized by nursing as well as pharmacy. The article is a much more limited version of the one by Koppel in 2008.²

The Annals article identifies some disturbing trends at the Medical University of South Carolina (MUSC) where the study took place. Examples include failure to document override reasons for 77% of alert messages and 468 directly observed workarounds during 121 administration attempts over a 6 hours period. Those number are a sure sign of a poorly designed system and lack of institutional oversight. It certainly has nothing to do with BCMA and the overall effectiveness of the technology. Sounds like some disciplinary action is in order.

One other thing I found unusual in the article was the classification of pharmacy workarounds. “Specific pharmacy workarounds included duplicate orders, lack of medication order verification, medications within the incorrect section of the eMAR (prn vs standard administration time), and incorrectly timed medications causing administration too late/early for the nursing staff.” I’m not sure how you see this, but a duplicate order isn’t a workaround, it’s an order entry error. Same goes for entering an order as PRN instead of SCH. Not sure what the author had in mind when he made the decision to classify these as workarounds. Weird.

1. Daniel F Miller, Christopher R Fortier, and Kelli L Garrison Bar Code Medication Administration Technology: Characterization of High-Alert Medication Triggers and Clinician Workarounds Articles Ahead of Print published on 1 February 2011, DOI 10.1345/aph.1P262. Ann Pharmacother ;45:162-168.
2. Koppel R, Wetterneck T, Telles JL, et al. Workarounds to barcode medication administration systems: their occurrences, causes, and threats to patient safety. J Am Med Inform Assoc 2008;15:408-23.

Here are a couple of examples of what I’m talking about.

• The two images below represent pre-mixed IV bags that contain two separate barcodes located closely together on the bag. Unfortunately one of the barcodes is useless. One barcode contains the unique identifier for the medication, in most cases some form of the medication’s NDC number, while the other contains the product’s lot number and expiration information. While it’s nice to have the lot number and expiration information encoded in a barcode located directly on the medication packaging, it creates a problem as this barcode cannot be used to identify the medication. In addition the information in that barcode changes based on the lot number and expiration number, which basically means it’s changing all the time.

• The image below is an interesting situation where the product contains two separate barcodes that are completely unrelated. In this specific example the product is “manufactured” from a secondary vendor by adding 20 units of pitocin to a 1 liter bag of normal saline. Unfortunately the barcode for the normal saline bag remains visible after the label identifying the compounded product is affixed to the bag. This creates confusion and frequent erroneous scans of the product.

I’ve been interested in the use of RFID technology in healthcare for quite some time. I think there’s real value in the use of RFID secondary to the ability to encode significant amounts of information in the tag. The information contained in an RFID tag could potentially include a patient’s medication regimen, allergies and medical condition. The value become obvious when you consider the possibilities during medication administration in the acute care setting.

The article has a great list of reasons why RFID should at least be considered a viable alternative to BCMA.

Barcoding presents challenges, however, especially with regard to barcode medication administration (BCMA).

• Barcoding requires human compliance—in order to perform its function, a barcode must be scanned and that requires a human to pull the trigger. If a human elects to bypass the process and not use the barcode scanner, there is little that can be done about it.
• Barcodes require line-of-sight scanning. To identify a patient, for example, the care provider must locate and scan the patient’s wristband. If the patient is asleep and resting on that hand, that means disturbing, and possibly waking, the patient.
• The scanner cannot verify that the barcode scanned is actually physically attached to the item it represents. There are well-documented instances of users producing surrogate copies of barcodes and scanning those surrogates, rather than scanning the barcodes actually affixed to the appropriate items (Koppel, et al., 2008).
• Barcode scanners cannot tell the difference between scanning 10 different instances of the same barcode (e.g., scanning 10 different medication vials) or scanning the same barcode 10 times (e.g., scanning the same vial 10 times). This means that people can “cheat” the system, and a user who loses track of where they are in a scanning process cannot tell if they have already scanned an item. It should be noted that the FDA has proposed a serialized National Drug Code (NDC) implementation that would improve this issue.
• When a large number of items must be scanned, users experience fatigue that may result in failure to scan some items, or increase the probability of the user taking shortcuts.
• Barcodes rely on print quality: a damaged barcode may not scan.
• Data is fixed at the time the barcode is printed; it cannot be updated.
• Barcode scanning typically requires a flat surface with high contrast. Barcodes on irregular surfaces (such as on a foil-wrapped suppository) or on surfaces without good printed contrast (such as an IV bag) are difficult to scan.
• On some packaging (notably IV bags), the container has multiple barcodes, and the provider cannot always tell which one they should scan.
• Barcode scanning of medications relies heavily on barcodes containing the NDC for which there is not a well-maintained definitive reference list.”

RFID technology in healthcare is in its infancy even though it’s an older technology, but in my opinion now is the perfect time to be exploring its use. Waiting for the technology to mature in healthcare means you’ve already missed the boat. In addition, having your hands in technology during it’s development offers the opportunity to influence future direction.

Here’s a cool video demonstrating some possible uses for RFID technology in healthcare. I especially like the part where the patient’s profile is automatically pulled onto a tablet pc once the patient has been positively identified via an RFID scanner in the tablet.

On a side note, I’ve seen articles popping up all over the internet this week talking about Apple’s use of the iPhone and iPod touch as a RFID transponder, and according to the Patently Apple website “the RFID antenna could be placed in the touch sensor panel, such that the touch sensor panel could now additionally function as an RFID transponder.” Details on the patent from Apple can be found here.

I have a small collection of RFID web clippings and articles that can be found in a shared Evernote Notebook. I haven’t been collecting information for long and the notebook is quite limited, but feel free to browse. If you know of a good article relating RFID to healthcare don’t hesitate to point me in the right direction.

The SNI document discusses the implementation of a package-level standardized numerical identifier (SNI) for prescription medications in an attempt to secure the drug supply chain and cut down on counterfeiting and diversion. SNIs are designed to address the Food and Drug Administration Amendment Act of 2007 (FDAAA), signed into law on September 27, 2007 by President Bush, which amends the Federal Food, Drug, and Cosmetic Act (FDC Act) and the Public Health Service Act. Section 913 of the FDAAA amends the FDC Act (section 505D) and requires the FDA to “develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adultered, misbranded, or expired drugs.” Specifically it calls for the FDA to develop a “standardized numerical identifier” no later than March 2010.

According to the SNI document “the SNI for most prescription drug packages should be a serialized National Drug Code (sNDC). The sNDC is composed of the National Drug Code (NDC) (as set forth in 21 CFR Part 207) that corresponds to the specific drug product (including the particular package configuration)4combined with a unique serial number, generated by the manufacturer or repackager for each individual package. Serial numbers should be numeric (numbers) or alphanumeric (include letters and/or numbers) and should have no more than 20 characters (letters and/or numbers). An example is shown below with a 10-character NDC.”

The FDA says they chose to use SNIs because they believe it “serves the needs of the drug supply chain as a means of identifying individual prescription drug packages,7 which in turn should facilitate authentication and tracking and tracing of those drugs.” The number does not include expiration or lot number information.

I don’t know about you, but I don’t think the FDA succeeded in doing anything except making things much more complex for foreseeable future. The use of SNIs brings up more questions in my mind than solutions. If and when SNIs goe into production I see trouble for healthcare systems that are already live with BPOC, especially those with older barcode scanners. I don’t know what testing has been done on SNIs as I couldn’t find information on any testing conducted on labels containing the additional numbers as part of the manufacturer’s barcode for medication packaging.

I understand the FDAs desire to keep things simple and cost effective, but I think other technologies might have been a better way to go. RFID comes immediately to mind. While digging around for information on the use of SNIs I came across an article in Pharmacy and Therapeutics (PT 2009 January; 34(1):14) that gives a little perspective on why RFID technology might not have been chosen. Based on information in the article, cost appears to be the largest barrier to use. Hopefully that will change as the cost of RFID technology continues to decrease, but for now it looks like we’re stuck with SNIs. Until someone can explain to me how SNIs are a good solution, I’m going to consider them a bad idea.

One Nucleus: “The technique will allow faster identification and resolution of any manufacturing quality problems but will also prove invaluable as an anti-counterfeit measure because the specific coding and validation systems are almost impossible to copy.

Currently most components within diagnostic kits, medical devices and other healthcare products and equipment are ‘stamped’ with a lot code at the point of manufacture. However, these codes are of limited use for quality improvement unless products are produced in very small batches. As a result, regulatory bodies across the world are now putting manufacturers under increasing pressure to invest in much more sophisticated traceability systems, while manufacturers are looking for effective ways to prevent the growing problem of counterfeiting of pharmaceuticals and other healthcare products.

The breakthrough approaches being developed by Innomech will enable manufacturers to mark products with a code that is either unique to the item or shared by only a small number of items produced together.

The codemark is an unobtrusive two-dimensional dot matrix identifier that is linked to a look-up database. In effect the matrix code acts as a ‘key’ to access much more detailed information, such as the specific batch codes of raw materials used during production, the time of manufacture, the production line and so on. A version of the database could be accessible online for anyone to verify the item is genuine.

The codes can be printed or laser etched onto products, applied to virtually any substrate and can even be added onto the surface of pharmaceutical capsules or coated tablets. Matrix codes can be as small as 2 mm by 2 mm holding the code for up to 10 billion numbers. The codes can be read by widely available readers or in many cases from a picture taken with even the simplest camera phone, making them ideal in the battle against counterfeit medicines.”

This is an interesting approach to an age old problem. I wonder if this technology could be used to embed drug information directly on the medication as well, an idea that I hijacked from the Nursetopia website where Joni Watson muses that “Both companies and pharmacies could add a QR code/Microsoft Tag to the medication label for patients and/or healthcare professionals to scan and directly access the patient medication information sheet.” Why not put the QR code directly on the medication itself? Why not indeed.