"When I first was telling people around the country that we were doing 2-D bar coding, everybody thought I was nuts," says Bill Churchill, executive director of pharmacy services at Brigham and Women's Hospital, part of Boston-based Partners HealthCare System. Five years after their project began, the pioneering work done on 2-D bar coding for patient safety has led to the development of a new standard currently up for public review by the Health Industry Business Communication Council (HIBCC). Once approved by HIBCC, the standard will go to ANSI for accreditation.
This patient safety standard, created in response to a growing trend to 2-D solutions, is for the use of intelligent, 2-D bar codes for patient wristbands, electronic medication administration records (eMARs), bar code scanning, IV medications in programmable infusion pumps, and more. The "Five Rights" for medication administration are embedded in the standard.
Why 2-D? Simply put, it's all about storage capacity. Thirty to 40 times more information can fit on a 2-D than a 1-D bar code, information that's critical to patient safety in medication administration. In order to do more sophisticated tasks such as programming an IV pump, for example, the bar code has to contain not only the patient name, but the medical record number, the name of the drug, the volume of the drug, expiration date, and calculated flow rate. The bar code is much more than a drug identifier — which is all the current FDA standard mandates — and an improvement hospitals may want to consider when looking for technology solutions.
"Back in 2002, when we were embarking on our eMARs, we made the decision to use 2-D data matrix bar codes because we wanted to include lot number, expiration date and NDC number for the drug," Churchill says.
Massachusetts General Hospital (also part of Partners) evaluated commercial systems and found that none met their 2-D requirements. "So we started making up our own format in-house. One of the biggest challenges was there really wasn't a 2-D standard for how we should do this. So we developed one."
HIBCC was a natural choice to accredit the standard for public use. "We're an ANSI- accredited standards group, and we have the mechanism to bring something like this project forward to ANSI," says Robert Hankin, CEO of HIBCC.
The HIBCC council was originally formed by the American Hospital Association (AHA) back in to '80s — and its first standards were for bar code labeling.
"The Partners project was a highly specialized example of the kind of thing that's in our application standard," Hankin says. "It's an expansion of it. Their original thought was that it would be inserted into our bar code standard, but our technical committee took a look at it and realized it had legs of its own."
New standards always entail a lot of background work. Partners configured high performance medicine improvement teams throughout its network to develop it.
According to Churchill, the outline was far from small. "The original document was 120 pages and the teams went through line by line and articulated what you need to do," he says. "When we get an order to fill a drug, we bar code scan the drug to verify that against the label. Then we track the process so we know the label was printed, the label was filled and the medication was verified. We scan it out of the pharmacy and we scan it up into the patient unit. We know where the drug is at every point of the process right up to the verification of the medication at the bedside."
Developing the bar code standard demanded some cultural changes too. "When you change your systems, and they're bi-directionally interfaced, it brings out differences in how people approach the care of the patient," Churchill says. "We needed to synchronize that, too." Tasks that the nursing department had previously performed, such as the scheduling of medications, fell to the pharmacy staff. The team designed different views for each user set based on what end-users wanted. "We got a lot of feedback from nurses, pharmacists and physicians," he adds. "They all looked at the eMAR differently."
The hospital had extensive classroom training for the staff, with super users helping out. "The nurses gave us a lot of great feedback" Churchill says. "Our most difficult task was prioritizing which suggestions went first because we got so much feedback."
Churchill says he feels the nursing satisfaction was so high because their suggestions were incorporated — a good example was the 2-D scanners. "We looked at a number of hardware vendors to get a wireless 2-D scanner. We went with a company called Code Corporation (Draper, Utah) because the nurses liked it. It was small, wireless, Bluetooth-enabled and connected to the wireless laptop."
According to Churchill, safety rates have improved with the new system.
"When we first put the pharmacy system up on the bar coding, we evaluated the efficacy of the bar code scanning and the error rate of pharmacy dispensing in a non-bar code environment," he says. "We found the accuracy was pretty good — about 99.1 percent. But, that .9 error rate translated to 54,000 potential errors a year."
After implementing the 2-D scanning, there was an 85 percent reduction in medication errors out of the pharmacy, he says. A cost benefit analysis found a payback of about $3.4 million over five years, based on the cost avoidance of adverse drug events. "It paid for itself in the first year of full implementation," Churchill says.
Success can sometimes bring challenges. "Our difficulty now is that we operated ahead of the curve for so long," he says. "Being ahead of the curve, there aren't a lot of companies out there yet that have the ability to read the 2-D bar code. But it is increasing."
The FDA requires a one dimensional linear bar code, and drug companies only have to meet that standard. Some of the pharmaceutical companies, particularly the generic companies, are beginning to use a combination of 1-D and 2-D; the 1-D keeps them in FDA compliance, while 2-D provides extra information like lot and expiration date. Similarly, many drug re-packagers are now coding 2-D — and touting it as a feature.
"We have to account for the rest of the world not being up to that standard yet," Churchill says. "That's why we want to get this out there. Hopefully the FDA standard will change quickly to accommodate 2-D bar coding so hospitals and vendors can use the power of that bar code to get more information into our systems."
The accreditation process has been a rewarding experience for Partners. "When we developed our standard we were looking to get feedback on it," says Churchill. "It was gratifying to have an HIBCC to pick up on it and reinforce that we were doing the right thing."
Hankin concurs: "This was an internal process at Partners that worked so well they thought it was a good idea to put it out for public use, as a public service. The public comment period that's open now will knit together various approaches. We answer every comment, put that out for review again and then wait for more comments to that. If there are competing approaches to the same problem, the purpose of the ANSI standard is to meld them together and work out those differences."
The standard can be reviewed, and public comments can be placed at http://www.hibcc.org/PatientSafety.htm.