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About Two-Dimensional (2D) Vaccine Barcodes

This page provides background information related to 2-dimensional vaccine barcoding initiatives.

Why Do We Need 2D Barcoding?

The National Childhood Vaccine Injury Act (NCVIA) requires documentation of vaccine product identification and vaccine lot number. The American Academy of Pediatrics (AAP) recommends documenting vaccine expiration date. However, these data are currently either handwritten or typed into an electronic medical record (EMR) system and/or immunization information systems (IIS) system, and are frequently missing or incorrect within IIS and Vaccine Adverse Event Reporting System (VAERS) reports. Implementation of a 2D barcode on vaccines could allow for rapid, accurate, and automatic capture of these data by a handheld imaging device, or scanner, which could populate these fields in an electronic health record (EHR) and/or an IIS. 2D barcodes can contain more information than linear barcodes in a smaller space.  Linear barcodes currently contain vaccine product identification information only.  If used for vaccines, 2D barcodes could contain the vaccine product identification information as well as the lot number and expiration date:

Caption from theme options

Linear Barcode

Vaccine Product Identification Only

image of linear barcode

2D Barcode

Vaccine product identification, Expiration Date, and Lot Number

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Adoption Strategies for 2D Barcodes Pilot

In October 2013, CDC initiated a second pilot project to assess the impact of the introduction of 2D barcodes onto vaccines with a focus on pharmacies and community vaccinators. With the increased number of 2D barcoded vaccines on the market, this project will expand the intent of the first pilot. This project will look at the data captured and operational process in a variety of settings  and interfaces between barcoded vaccines, EMRs, and IIS.

Primary Objectives

  • Evaluate the effect of 2D barcodes on the completeness and accuracy of vaccine administration data
  • Obtaining practitioner perspectives on 2D barcode adoption and use
  • Observe the effect of 2D barcoded vaccines on practice inventory and vaccination operations. 

The project enlisted three vaccine manufacturers (GlaxoSmithKline, Merck, and Sanofi Pasteur), a number of CDC 317 Immunization awardees, and approximately 100 immunizers. 

The participating manufacturers placed 2D barcodes containing product identifier, lot number, and expiration date onto selected vaccines primary packaging. These barcoded vaccines were then distributed via the normal supply chain to the participating providers. The providers administered these vaccines and used scanners to read the data contained in the 2D barcodes. The scanners populate data directly into the immunizer’s electronic record systems for each vaccine.

Additionally, a subset of the participating immunizers has been selected to participate in a time and motion study to assess the impact of 2D scanners and barcoded vaccine products on administration and inventory procedures.

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2D Vaccine Barcode Pilot

In September 2011, CDC initiated a pilot project to assess the impact of the introduction of 2D barcodes onto vaccines.

Primary Objectives

  • Evaluate the effect of 2D barcodes on the completeness and accuracy of vaccine administration data
  • Obtaining practitioner perspectives on 2D barcode adoption and use
  • Observe the effect of 2D barcoded vaccines on practice inventory and vaccination operations. 
  • Apply 2D barcodes to Vaccine Information Statements (VIS)

Pilot at-a-Glance

  • Vaccination information collected Aug 2012 - May 2013
  • 10 Immunization Awardees

New Jersey
New York
Oregon
Florida
Wyoming

New York City
Washington
Michigan
Iowa
Alaska

  • 217 public and private practices
  • 2 Vaccine Manufacturers

GlaxoSmithKline

Sanofi Pasteur

Summary Report of 2D Vaccine Barcode Pilot

The report contains the following sections:

  • Introduction
  • Context and Background
  • The Implementation Pilot
  • Evaluation Purpose and Methodology
  • Results
  • Strengths and Limitations of the Evaluation
  • Benefits of the Pilot Project to Date
  • Conclusions
  • Recommendations
  • References

A Summary Report of the Pilot [27 pages] is available. 

Development and Placement of 2D Barcodes on VIS — Vaccine Information Statements (VIS)

All VIS have been modified to contain a two dimensional barcode with the VIS type and the VIS Publication Date.  Providers are also required to document in the patient’s permanent record the VIS publication date.  With these barcodes providers have the potential to scan and input the VIS information into the patients’ EHR.  For more detailed information, go the barcodes on Vaccine Information Statements.

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2013 Education Forum

The 2D Vaccine Barcode Pilot's (Pilot) Education Forum (Forum) was conducted April 14-15, 2013.  Seventy eight (78) immunization community stakeholders including vaccine manufacturers, public and private immunizing providers, and electronic medical record (EMR) vendors, Immunization Information System (IIS) staff, and 2D barcode scanner vendors came  together to discuss successes, opportunities, challenges and next steps for implementing 2D barcoding on vaccine products. 

Speaker presentations and panel discussions shared insights gained through the CDC 2D Vaccine Barcode Pilot, vaccine manufacturer application of 2D barcodes, Electronic Medical Record (EMR) and Immunization Information System (IIS) enablement of 2D barcode scanning, and immunizer adoption of 2D barcode vaccine scanning into practice operations. Facilitated working sessions produced rich discussion on the foremost interests and concerns of the immunization community in the areas of 2D barcoded vaccine standards, adoption and implementation.

The multiple immunization community perspectives represented at the Forum produced several valuable recommendations and helped to more clearly define required next steps in the advancement 2D barcoded vaccine use.

Forum Summary Document

Two-Dimensional (2D) Vaccine Barcoding Pilot Education Forum Report[54 pages], Summarizes the content presented at the Education Forum and includes questions and answers from attendees as well as a summary of the working sessions.

Forum Presentations

Presenter Presentation
Elizabeth Sobczyk, MSW, MPH
Manager, Immunization Initiatives, American Academy of Pediatrics
The 2D Barcode History and Progress[13 pages]
Paul Robinson
Team Lead, Deloitte Consulting LLP
2D Infrastructure Scanner Overview and Selection[10 pages]
Erin Kennedy, DVM, MPH
Medical Officer, CDC/NCIRD
The 2D Barcoding Pilot - Background and Overview[14 pages]
Marshall Gaddis, MS
Analytics Consultant, Deloitte Consulting LLP
The 2D Barcoding Pilot Lessons Learned & Early Findings[11 pages]
Kenneth Gerlach, MPH, CTR
Health Scientist, CDC/NCIRD
VIS Overview[13 pages]
Andrew Sharpin, MBA
Senior Consultant, Deloitte Consulting LLP
Workflow Analysis [13 pages]
Paul Robinson
Team Lead, Deloitte Consulting LLP
Breakout Sessions Overview[33 pages]

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2012 Vaccine Manufacturer’s Forum

A 2D vaccine barcoding manufacturer's forum was conducted in January 2012 to inform manufacturers and other stakeholders about the pilot project and to identify challenges and potential solutions. Over 60 industry stakeholders attended, including representatives from vaccine manufacturing companies, retail pharmacies, standards organizations, as well as the World Health Organization (WHO), The Food and Drug Administration (FDA) and CDC. A report summarizing the forum[32 pages] is now available.

 

2010 Potential Impact Assessment

CDC initiated a study in 2010 of the impact of vaccine products with 2D barcodes on vaccine production, clinical documentation, and public health reporting. The data items within the proposed 2D barcodes included product identification, lot number, and expiration date.

Study Objectives

Engage stakeholders - Document knowledge, attitudes, and beliefs about the impacts and implications of 2D barcodes.

Conduct prospective economic impact analyses - Assess societal, manufacturer, and healthcare provider economic benefits and costs, and the distribution of these costs and benefits across stakeholders.

Conduct data exchange analysis and information technology standards mapping - Review the exchange of health information and data standards relevant to 2D barcodes to assess how information can be transmitted across stakeholders. This issue is particularly important as the United States moves from primarily paper-based medical records system to electronic ones. A feasibility assessment and a series of recommendations about how to incorporate the information captured from the barcode into both the relevant standards and the guidance was produced.

Final Report

A final report [2.54 MB, 231 pages] from this project is available.

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