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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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2D Vaccine Barcode Pilot

In September 2011, CDC initiated a pilot project to test the implementation, using industry barcoding standards, of 2D barcodes on vaccine products.  This pilot is still in progress and will be completed in May 2013.

Pilot Project Components

Pilot Implementation of 2D Barcoded Vaccines – The project will ensure implementation of 2D barcoding in one or more manufacturing settings and a sample of provider offices, with special emphasis on the interfaces between barcoded vaccines, EMRs, and IIS.

The project enlisted two vaccine manufacturers, 10 CDC 317 Immunization grantees (see map below), and approximately 220 immunizers among the 10 CDC grantee locations as pilot participants.

Figure is a color coded illustrated map of the United States that depicts Participating Immunization Grantees. The map is divided into three sections and shows the Participating Immunization Grantees by state or major metro area as follows:
US Mountain/West – Washington, Oregon, Wyoming Alaska
US Midwest/Central – Iowa, Michigan, Chicago, Dallas, San Antonio, Houston
US East – New York, New York City, New Jersey, Philadelphia, Washington D.C., Florida

The immunizers included private providers, publically-funded health services, and one pharmacy. The participating manufacturers placed 2D barcodes containing product identifier, lot number, and expiration date onto specific vaccines they produce. 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 2D barcodes. The scanners input data directly into the immunizer’s electronic record systems for each patient, and then were transmitted to or captured by the states' IIS:

Figure is a graphic that illustrates information flow for the pilot implementation of 2D vaccine barcoding. The information flow is:
Manufacturer - Add a 2D barcode to the primary packaging. The data matrix barcode will contain the Global Trade Item Number (GTIN), expiration date and lot number. Distribute to pilot participants.
Immunizer - Record and track data by scanning the barcode when inventorying and dispensing vaccine products. Enter into the medical record.
Record System - Medical record types; electronic medical records (EMR) and custom applications act as a source of evaluation for data accuracy and completeness.
IIS - Receive data from the immunizers’ EMR or equivalent electronic system. This also acts as a source of evaluation for data accuracy and completeness.

The vaccine information was tracked from manufacturer to immunizers to EHR to IIS.  The goal of this pilot implementation of 2D barcoded vaccines and scanners was to assess their impact on the completeness and accuracy of vaccine data in both the EHR and the IIS.  Additionally, a subset of the participating immunizers were selected to participate in a work flow analysis and time and motion study in order to also assess the impact of 2D scanners and barcoded vaccine products on administration and inventory procedures. This phase included process maps, time measurements and staff interviews. These were collected both before and after the introduction of 2D capabilities within the provider site.

Development of Technical Assistance Documents - Technical assistance tools and guidance are being developed for pilot participants and for use by the broader immunization community. In collaboration with immunization partner organizations, educational forums will be conducted to discuss implementation issues, promote barcoding standards and guidance, increase awareness, and share project findings. Web-based tools for barcoding resources also being developed.

Development and Placement of 2D Barcodes on VIS - Vaccine Information Statement (VIS) Encoding - All VIS will be modified to contain a two-dimensional barcode containing the VIS type and the VIS publication date. Providers are also required to document in the patient’s permanent record the VIS publication date. The VIS barcode will be affixed to the area adjacent to the printed text. With these barcodes providers will have the potential to scan and input the VIS information into the patients’ EHR. For more detailed information, go to 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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