Pilot program explores use of 2D barcodes in vaccine record-keeping

In an effort to help facilitate the keeping of accurate and uniform records of U.S. vaccine use, the Centers for Disease Control and Prevention (CDC) and immunization community stakeholders have been exploring the potential of two-dimensional (2D) barcoding to streamline immunization practices.

Purpose and options

The 2D vaccine pilot initiative, begun by the CDC in 2011 with support from key organizations such as FDA, the American Academy of Pediatrics (AAP), and various manufacturers, seeks to improve the documentation and efficiencies needed to capture key information connected with vaccine delivery, said Warren Williams, a public health analyst with CDC’s National Center for Immunizations and Respiratory Diseases.

“Vaccine providers and immunization programs that are administering vaccines may be interested to know that a variety of vaccine unit-of-use products [vials/syringes] are available and contain a 2D barcode, which contains more information than the traditional linear barcode,” Williams said. “Currently we are conducting a pilot to understand some of the impact of this technology.”

The big issue

Edward Zissman, MD, FAAP, co-chair of the AAP Vaccine Barcoding Project, said, “The No. 1 issue is the safety of the children. The second thing is accuracy and efficiency in the pediatric office, where immunizations in this country are most often given, in private pediatric offices. Currently, the administrating medical assistant or nurse or physician has to write down the lot number or the expiration date with the name of the product. By doing 2-D bar coding, which is very well recognized in other industries, it will put all of that information immediately into a child’s electronic health record, so there will be a significant increase in
accuracy and efficiency.” 

Dimensions and data

At present, vaccine unit-of-use products carry a linear barcode that holds information on the product identification only, specifically the National Drug Code (NDC). The new 2D barcodes are square and about the size of small thumbnail; along with the NDC code they hold additional information, including the lot number and the expiration date of the product. A 2D barcode with Data Matrix technology can hold approximately 2,300 characters; a traditional linear barcode can hold approximately 48 characters.

“All of this information is needed to document the vaccine encounter, and typically it has to be manually read and recorded by hand,” Williams said. “The new 2D barcode can be scanned, and depending on the computer system configuration, populates the necessary fields in the record system. By having all this information, such as the NDC code, lot number, and expiration date, available to be derived from ‘scannable’ technology, we think that it can improve documentation concerns, prompts for decision support, and manual data-recording burden.”

Hardware and software

Vaccine manufactures can request a label change from FDA to add this alternate barcode to the vaccine vial/syringe.

Recently, GlaxoSmithKline received FDA approval to add 2D barcoding to both the inner containers and outer boxes of most of its U.S. vaccines, a step that supports electronic medical record [EMR] keeping, according to Leonard Friedland, MD, vice president, scientific affairs and public policy, GSK vaccines, North America. 

“With the necessary hardware and software for this technology, healthcare providers can update their inventory management system, patient records, and vaccination reports automatically, reducing the need for manual entry of information, which can be susceptible to administrative errors and incomplete record keeping,” Friedland said. “In addition, through the regular electronic scanning of the additional information contained in 2D barcoding, we believe that a more accurate and complete picture of U.S. vaccine usage could emerge.”

With 2D barcodes, healthcare providers who have the necessary hardware and software can scan the information automatically into a patient’s immunization record. Healthcare providers need an EMR or electronic health record (EHR) system and a 2D barcode scanner. 2D barcoding may work with a number of systems. 

According to Williams, providers will have to have some hardware, such as a scanner. There are also software configuration and support issues. 

The following costs could be associated with implementing and maintaining barcode use in provider offices:

• Purchase of scanners and periodic replacements

• Modification or enhancement of EHRs to accommodate barcode scanning

•  Staff training

• Miscellaneous scanner maintenance costs

• Maintenance of connections to state IIS or any barcoding-specific software.

A list of factors that providers must consider can be found at http://bit.ly/2Dcdc.