New Orleans—Boston researchers have developed a bar code–based syringe-labeling system they believe has the potential to significantly improve patient safety and workflow in the operating room.

A pair of studies by the investigators revealed that the technology not only provides full compliance with requirements of both the Joint Commission and the American Society of Anesthesiologists (ASA), it also improves the efficiency of the clinicians who use the device. And it passed muster with at least one pharmacist who specializes in medication safety in the operating suite.

The system, a bar code–driven method of printing full Joint Commission-compliant drug labels at the time that the OR clinician draws up the syringe, “certainly makes sense, and it’s something that we would consider for the medications that we cannot prepare in the pharmacy department beforehand,” said Meagan Rushe, PharmD, manager of the Shock Trauma and OR Pharmacy satellites at the University of Maryland Medical Center (UMMC), in Baltimore. Dr. Rushe stressed that preparing doses in the pharmacy “is always the best way to ensure safety.”

Not a Lone Struggle

Wilton C. Levine, MD, clinical director of anesthesia, critical care and pain medicine at Massachusetts General Hospital (MGH), who led the research, said that the bar code–based syringe-labeling project “started about three years ago as an internal compliance project and very quickly became a patient safety project. We suspected we had difficulty meeting all the regulatory compliance for properly labeling syringes, and we knew from talking to our colleagues around the country that we were not the only ones who struggled with this.”

Dr. Levine and his colleagues set out to create a simple, user-friendly system that could quickly and easily generate a label meeting all of the regulatory compliance requirements of the Joint Commission.

The result is the SmartLabel system, which produces Joint Commission- and ASA-compliant syringe labels on demand at the point of care. “When you use this new bar-coding system, you take a vial of medication that you want to draw up into a syringe and scan it,” said co-investigator Karen Nanji, MD, a resident at MGH. “A few seconds later, it prints a label with the name of the medication, the concentration, the date and time it was drawn up, expiration information and the name of the person who drew it up.”

The system produces an audible readout of the drug name and concentration where appropriate, as well as any alerts if the vial has expired.

“And all of that happens as you’re drawing up the medication,” Dr. Nanji said. “So by the time it’s in the syringe, the label is ready to go. This is where the time-saving comes in, because you don’t have to manually write all the information after you’ve drawn up the drug.”

In the first of two studies presented at the 2009 annual meeting of the ASA (abstract A609), the researchers evaluated physicians’ baseline compliance with labeling requirements over a one-month period. Syringes were assessed for a variety of elements, including drug name, concentration, preparation date and time and clinician initials. SmartLabel was then installed in five operating rooms.

The study found that of the 1,090 syringes evaluated as part of the baseline study, 497 (45.6%) were prefilled by the pharmacy or a third-party vendor, whereas 593 (54.4%) were prepared by the clinician. Of those prepared by clinicians, only 269 met Joint Commission requirements for proper labeling.

Failure took many forms: 257 labels carried only the drug name; 35 had the drug name and concentration but no expiration date; and 32 syringes had no label at all (Figure, page 36).

After the labeling system was implemented, the researchers evaluated 340 labels, 139 of which (41%) were prefilled. Of the remaining 201 (59%) prepared by clinicians, 100% were fully compliant with both Joint Commission and ASA requirements.

Another Comparison

In a second study (abstract A612), the investigators observed and timed 64 clinicians during preparation of three medications—succinylcholine, propofol and atropine—using the SmartLabel system and conventional, manual-entry techniques. At the conclusion of the study, participants also completed a survey about their experiences.

Preparation times were shorter using the SmartLabel system (129.9 vs. 138.6 seconds; P=0.01). This difference persisted for all three drugs: propofol, 50 versus 56.6 seconds; succinylcholine, 43.7 versus 44.6 seconds; and atropine, 38.2 versus 41.4 seconds.

Twenty errors were found in the 192 syringes prepared using the conventional method (10.4% error rate). These errors included incorrect time or date and wrong concentration of the drug. No errors were found using the SmartLabel system.

As Dr. Nanji told Pharmacy Practice News, clinicians readily accepted the automated labeling system. “We found that 86% perceived it to be faster,” she said. “A full 95% thought it fit well into the workflow, 97% thought it was user-friendly and easy to use, while 98% thought it improved patient safety. That kind of satisfaction data says a lot about how easy it is to implement as a system, because one of the biggest barriers to implementing new technology is physician resistance due to the technology not fitting well into their workflow.”

Yet as with any type of technology, there is room for error. “The power could go out, or the machine could run out of ink or labels,” Dr. Levine said. “All machines have failure modes, but we accept them as part of the proposition.”

Premixed Meds Crucial

Dr. Rushe said the fact that about half of the medications used in MGH ORs were drawn by OR staff makes sense, because a similar percentage occurs at UMMC. “The drawn medications are those that are more prone to error (some serious) or are more likely to generate regulatory issues,” she said. “So, no doubt, automation of the labeling process has its benefits.”

At UMMC, Dr. Rushe said, “we’re striving to lower the [percentage of medications prepared by the OR staff] by enhancing our ability to stock premixed syringes in the OR.”

The limiting factor, to date, has been automated drug cabinets (ADCs) that need to be retrofitted to accommodate the larger size of the premixed syringes. “The ADCs we currently have in our OR suites can handle some prefilled syringes, but the space is insufficient to meet the anesthesiologists’ needs. We’re adding drawers with new reconfigurations that can stock more premixed syringes.”

Two new drugs—ephedrine and phenylephrine—are currently being added, Dr. Rushe said. Other premixed medications that may be stocked include rocuronium, succinylcholine, fentanyl and methadone.

The cart reconfiguration effort yields multiple benefits, Dr. Rushe noted. “The most obvious is that the medications are prepared in the pharmacy department in compliance with USP Chapter <797> sterile compounding regulations,” she said.

“Bottom line, pharmacy-based preparation of sterile products for the OR decreases the risk for contamination and reduces the potential for error.”

Dr. Rushe pointed to another benefit: “When a premixed syringe is removed from the ADC anesthesia cart, its bar code can be scanned for charge capture, thus maximizing drug reimbursement.” And once UMMC connects the ADC system to the electronic anesthesia record the facility is planning to roll out, she said, “we’ll have an effective tool for identifying drug diversion.”

Can We Talk?

An additional medication safety initiative at UMMC takes a lower-tech approach: a committee of nurses, pharmacists, nurse anesthetists and anesthesiologists that meets once a month to discuss issues that could impact the quality of OR care. “We call it our OR Medication Process Improvement Committee,” Dr. Rushe said, “and it’s impressive how constructive communication across the care team improves the identification of safe medication practices.”

—With additional reporting by David Bronstein