ATLANTA – Since the first bar coded consumer product, a pack of gum, was scanned in June of 1974, the soon widespread use of bar codes changed little until 2D bar codes arrived toward the end of last century. Today, the increasing use of 2D bar code technology with vaccines offers practices the potential for greater accuracy and efficiency with vaccine administration and data entry – if they have the resources to take the plunge.
An overview of 2D bar code use with vaccines, presented at a conference sponsored by the Centers for Disease Control and Prevention, provided a glimpse into both the types of changes practices might see with adoption of the technology and the way some clinics have made the transition.
Courtesy National Center for Immunization and Respiratory Diseases
Ken Gerlach, MPH, of the Immunization Services Division at the CDC in Atlanta, outlined the history of bar code use in immunizations, starting with a November 1999 Institute of Medicine report that identified the contribution of human error to disease and led the Food and Drug Administration to begin requiring linear bar codes on pharmaceutical unit-of-use products to reduce errors.
Then, a meeting organized by the American Academy of Pediatrics in January 2009 with the FDA, CDC, vaccine manufacturers, and other stakeholders led to a bar code rule change by the FDA in August 2011 that allowed alternatives to the traditional linear bar codes on vaccine vials and syringes.
“They essentially indicated to the pharmaceutical companies that it’s okay to add 2D bar codes, and this is essentially the point where things began to take off,” Mr. Gerlach explained. Until then, there had been no 2D bar codes on vaccines, but today the majority of vaccine products have them, as do all Vaccine Information Statements. In addition to the standard information included on traditional bar codes – Global Trade Item Number (GTIN), lot and serial numbers, and the expiration date – 2D bar codes also can include most relevant patient information that would go into the EMR except the injection site and immunization route. But a practice cannot simply jump over to scanning the 2D bar codes without ensuring that its EMR system is configured to accept the scanning.
Mr. Gerlach described a three-part project by the CDC, from 2011 through 2017, that assesses the impact of 2D coding on vaccination data quality and work flow, facilitates the adoption of 2D bar code scanning in health care practices, and then assesses the potential for expanding 2D bar code use in a large health care system. The first part of the project, which ran from 2011 to 2014, involved two vaccine manufacturers and 217 health care practices with more than 1.4 million de-identified vaccination records, 18.1% of which had been 2D bar coded.
Analysis of data quality from that pilot revealed an 8% increase in the correctness of lot numbers and 11% increase for expiration dates, with a time savings of 3.4 seconds per vaccine administration. Among the 116 staff users who completed surveys, 86% agreed that 2D bar coding improves accuracy and completeness, and 60% agreed it was easy to integrate the bar coding into their usual data recording process.
The pilot revealed challenges as well, however: not all individuals units of vaccines were 2D bar coded, users did not always consistently scan the bar codes, and some bar codes were difficult to read, such as one that was brown and wouldn’t scan. Another obstacle was having different lot numbers on the unit of use versus the unit of sale with 10% of the vaccines. Further, because inventory management typically involves unit of sale, it does not always match well with scanning unit of use.
Clinicians’ beliefs and attitudes toward 2D bar coding
As more practices consider adopting the technology, buy-in will important. At the conference, Sharon Humiston, MD, and Jill Hernandez, MPH, of Children’s Mercy Hospital in Kansas City, Mo., shared the findings of an online questionnaire about 2D bar coding and practices’ current systems for vaccine inventory and recording patient immunization information. The researchers distributed the questionnaire link to various AAP sections and committees in listservs and emails. Those eligible to complete the 15-minute survey were primary care personnel who used EMRs but not 2D bar code scanning for vaccines. They also needed to be key decision makers in the process of purchasing technology for the practice, and their practice needed to be enrolled in the Vaccines for Children program.
Among the 77 respondents who met all the inclusion criteria (61% of all who started the survey), 1 in 5 were private practices with one or two physicians, just over a third (36%) were private practices with more than two physicians, and a quarter were multispecialty group practices. Overall, respondents administered an average 116 doses of DTaP and 50 doses of Tdap each month.
Protocols for immunization management varied considerably across the respondents. For recording vaccine information, 49% reported that an administrator pre-entered it into an EMR, but 43% reported that staff manually enter it into an EMR. About 55% of practices entered the information before vaccine administration, and 42% entered it afterward. Although 57% of respondents’ practices upload the vaccination information directly from the EMR to their state’s Immunization Information System (IIS), 30% must enter it both into the EMR and into the state IIS separately, and 11% don’t enter it into a state IIS.
More than half (56%) of the respondents were extremely interested in having a bar code scanner system, and 31% were moderately to strongly interested, rating a 6 to 9 on a scale of 1 to 10. If provided evidence that 2D bar codes reduced errors in vaccine documentation, 56% of respondents said it would greatly increase their interest, and 32% said it would somewhat increase it. Only 23% said their interest would greatly increase if the bar code technology allowed the vaccine information statement to be scanned into EMRs.
Nearly all the respondents agreed that 2D bar code scanning technology would improve efficiency and accuracy of entering vaccine information into medical records and tracking vaccine inventory. Further, 81% believed it would reduce medical malpractice liability, and 85% believed it would reduce risk of harm to patients. However, 23% thought bar code technology would disrupt office work flow, and a quarter believed the technology’s costs would exceeds its benefits.
Despite the strong interest overall, respondents reported a number of barriers to adopting 2D bar code technology. The greatest barrier, reported by more than 70%, was the upfront cost of purchasing software for the EMR interface, followed by the cost of the bar code scanners. Other barriers, reported by 25%-45% of respondents, were the need for staff training, the need to service and maintain electronics for the technology, and the purchase of additional computers for scanner sites. If a bar code system cost less than $5,000, then 80% of the respondents would definitely or probably adopt such a system. Few would adopt it if the system cost $10,000 or more, but 42% probably would if it cost between $5,000 and $9,999. Even this small survey of self-selected volunteers, however, suggested strong interest in using 2D bar code technology for vaccines – although initial costs for a system presented a significant barrier to most practices.