1 

EHR/IIS 2D Barcode Functional 

Capabilities Guide

Version 2.4 

September 2022

Prepared for

Immunization Services Division, National Center for Immunization and Respiratory 

Diseases, Centers for Disease Control and Prevention

Prepared by

Deloitte Consulting, LLP
2 

Table of Contents

Table of Contents.................................................................................................................................................. 2

Change Log............................................................................................................................................................ 4

Feedback............................................................................................................................................................... 8

Introduction.............................................................................................................................................. 9

1.1 Purpose................................................................................................................................................. 9

1.2 Scope..................................................................................................................................................... 9

1.3 Audience ............................................................................................................................................. 10

1.4 Contents.............................................................................................................................................. 10

Barcode Basics........................................................................................................................................ 10

2.1 2D Barcode Utility............................................................................................................................... 10

2.2 2D Vaccine Barcode Symbology.......................................................................................................... 12

Functional Capabilities Overview ........................................................................................................... 12

3.1 Need.................................................................................................................................................... 12

3.2 Assumptions and Considerations ....................................................................................................... 12

3.3 Requirements...................................................................................................................................... 13

4.0 Use Cases with Functional Capabilities................................................................................................... 15

4.1 Scenario 1a – Record vaccine inventory (EHR)................................................................................... 15

4.2 Scenario 1b – Record vaccine inventory (IIS)...................................................................................... 16

4.3 Scenario 2 – Record vaccine administration (Administration) ........................................................... 18

4.4 Scenario 3 – Record Vaccine Information Statements (VIS)............................................................... 22

5.0 Functional Capabilities Details................................................................................................................ 24

5.1 Scenario 1 – Record Vaccine Inventory (EHR/IIS)............................................................................... 24

5.1.1 Inventory Assumptions and Considerations.......................................................................................... 24

5.1.2 Inventory Process Flows..................................................................................................................... 26

5.1.3 Inventory Functional Capabilities Details................................................................................... 27

5.2 Scenario 2 – Record Vaccine Administration...................................................................................... 31

5.2.1 Administration Assumptions and Considerations .................................................................................. 31

5.2.2 Administration Process Flow............................................................................................................... 32

5.2.3 Administration Functional Capabilities Details...................................................................................... 33

5.3 Scenario 3 – Record VIS ...................................................................................................................... 37

5.3.1 Assumptions and Considerations......................................................................................................... 38

5.3.2 Recording VIS Process Flow................................................................................................................. 39
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5.3.3 Functional Capabilities Details............................................................................................................. 39

6.0 Appendices ............................................................................................................................................. 42

Appendix A - Methods Used to Gather Requirements................................................................................... 42

Pilots ........................................................................................................................................................... 43

One-on-one Interviews............................................................................................................................... 44

EHR 2D Barcode Functional Capability Open Forum (Forum) .................................................................... 44

Post Forum One-on-one Discussions .......................................................................................................... 45

Ongoing discussion with Providers............................................................................................................. 45

Appendix B - Factors Influencing Implementation ......................................................................................... 46

Appendix C - 2D Barcode Standards............................................................................................................... 47

GS1 DataMatrix Symbology ........................................................................................................................ 47

Unit of Use: 2D Vaccine Barcode Data Structure........................................................................................ 47

VIS 2D Barcode Data Structure ................................................................................................................... 48

Unit of Sale: 2D Vaccine Barcode Structure – Drug Supply Chain Security Act (DSCSA)............................ 49

Appendix D - Useful Resources....................................................................................................................... 51

Appendix E - References................................................................................................................................. 52
4 

Change Log

Date Version Change

July 2013 1.0 Initial publication

Oct 2014 1.1 a. Input change log

b. Section 2, Introduction. Replaced “pilot” with “CDC 2D barcodeinitiatives”

c. Entire report: Changed language describing pilot activities from present to

past tense.

d. Updated Table 1. 2D Vaccine Barcoded Products in Distribution to reflect

current 2D barcoded vaccines. Added link to current table on CDC page.

e. Updated Table 9: 2D Barcoded VIS to reflect current 2D barcodedVIS

f. Entire report: Standardized inconsistent spacing followingsentences

g. Entire report: Replaced “product identification” with “productidentifier”

h. Entire report: Replaced instances of “EHR/IIS system” with “EHR/IIS”

i. I-P-02, A-P-02: Added detail to read the entire lot number from a 2D

barcode scan

j. I-P-07, A-P-07: Added direction how to process “00” day in expirationdate

k. V-P-07: Added clarification on allowing multiple VIS per singleinjection.

l. Entire report: Minor grammar adjustments

Sept 2016 1.2 a. Updated Section 3, Background, to reflect current state and updates for2DA.

b. Updated Table 1 to reflect current 2D barcodedvaccines.

c. Removed Table 9 (Appendix F) as all VIS have 2Dbarcodes

d. Removed Appendix A (advisors list) (and renumberedAppendices)

e. Fixed references to Appendicesthroughout

f. Added clarification to A-P-09 regarding inventory and unit of use/ unit of

sale to decrementing process

g. Added section 7.4 for special considerations forpharmacies

May 2017 1.3 a. Updated Section 7.1.1 to reflect current guidance on serial numbers

contained in vaccine packaging.

b. Updated Section 7.1.4 to incorporate additional detail on scanner

configuration.

c. Updated Section 7.3.1 to incorporate additional detail on VISdocumentation

d. Added additional documentation to AppendixD.

e. Entire report: Minor grammar adjustments
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Date Version Change

Oct 2018 2.0

a. Entire report: Updated content and streamlined document organization for

improved usability.

a. Renumbered sections

b. Renamed appendices

b. Entire report: Replaced instances of “EMR/IIS” with “EMR/IIS”

c. Entire report: Replaced instances of “primary packaging” with “unit of use”

d. Entire report: Replaced instances of “secondary packaging” with “unit of sale”

e. Updated section 1.0: Updated language to clarify purpose of document.

September 

2019 2.1

a. Changed title of document to Functional Capabilities Guide

b. Updated section 4.1: added inventory module to the types of system modules

c. Updated section 4.2, table 4: Added note that some vaccines have multiple

components and systems should be able to scan data for all

d. Updated section 4.2, A-P-02: added serial number to information for Unit of

Sale; differentiated between UoS and UoU

e. Updated section 5.1: updated DSCSA information

f. Updated section 5.2.1: added paragraph “EMR/IIS can record both lyophilized

and diluent (or adjuvant and vaccine) components of vaccine”

g. Entire report: Formatted tables to ensure all content can be viewed
6 

Date Version Change

July 2020 2.2

a. Entire report: Reviewed entire report and separated EMR and IIS where

applicable

i. Added and Renumbered sections

b. Entire report: Replaced 2D vaccine barcode with Vaccine 2D barcode

c. Entire report: Replaced GTIN with GTIN/NDC where applicable

d. Updated section 1.2: Added paragraph “Although the functional capabilities

required to capture and process the 2D barcode are similar in both the EMR

and IIS...as defined by the CDC”

e. Updated 2.1: Replaced 2D Barcode Usage with 2D Barcode Utility

f. Updated 3.1: Separated Scenario 1 (Vaccine Inventory) into Scenario 1a

(Vaccine Inventory- EMR) and 1b (Vaccine Inventory- IIS)

g.

h.

Updated 4.0: Tailored scenario 1 for Vaccine Inventory recording for EMR 

only Added 4.1: Added Scenario 1b which is tailored to vaccine inventory 

recording for IIS only

i. Updated section 4.3: Added a last row to the EMR/IIS interaction table to

document how EMR directly reports vaccine administration data to the IIS

j. Updated section 4.4: Deleted instances of IIS

k. Updated section 5.1: Added paragraph “IIS records inventory by entering...

depletion”

l. Updated section 5.1.2: Re-created figure into two figures namely EMR

inventory management process flow and IIS inventory management &

reporting process flows. Also updated section text to reflect changes to

process flow and a paragraph about decrementation.

m. Updated section 5.2.1: Added an assumption/consideration titled “Reporting

of vaccine administration data to the IIS”

n. Updated 5.2.2: Updated process flow

o. Updated 5.3.2: Updated process flow
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Date Version Change

May 2021 2.3

a. Entire document: format and clarifying wording changes

b. Updated section 2.1 to add alternative vaccine presentations (packets of

powder, tablets)

c. Formatted Tables 1, 3, 4, 6

d. Updated 2.1 to include COVID-19 Fact Sheets for EUA vaccines
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Date Version Change

September 

2022 2.4

a. Entire document – terminology update (‘EMR’ to ’EHR’ and ‘patient’ to ‘vaccine

recipient)

b. Introduction section: revised to include importance of scanning functionality,

especially in the emergency response setting.

Feedback

If you have feedback regarding the content of this document or suggestions for improvement, please contact 

iissb2dbarcode@cdc.gov.
9 

Introduction 

A primary goal of the Centers for Disease Control and Prevention’s (CDC) vaccine two-dimensional (2D) 

barcode initiatives is to explore the potential of scanning 2D barcodes on vaccine-related products in terms 

of data quality and timeliness of the data capture. 

Since 2010, CDC has launched three pilots related to vaccine 2D barcode scanning. These pilot efforts have 

drawn attention to the benefits of 2D barcoding at provider sites. As a result, they have helped to initiate the 

adoption of 2D barcodes by vaccine manufacturers, providers, and electronic health record 

(EHR)/immunization information system (IIS) vendors. As 2D barcode adoption continues to increase, it is 

critical that EHR/IIS software solutions can read and translate data from the barcodes.

This ability to translate data meaningfully from a scanned data string to input data into the IIS or EHR system 

is also known as ‘scanning functionality’. Functional capabilities are the structure that support scanning 

functionality.

The surge in vaccinations caused by the COVID-19 Emergency Response highlighted the importance of 

scanning functionality in health information systems (HIS) to accurately capture vaccination data for vaccine 

recipients. Vaccination providers can scan 2D barcodes on vaccine products to capture lot numbers, 

expiration dates, and national drug codes (NDCs) quickly and accurately. Scanning functionality is critical for 

vaccination providers to use vaccine scanning practices.

1.1 Purpose

The purpose of this document is to serve as a guide for software developers to describe the EHR/IIS 2D 

barcode functional capabilities identified throughout the implementation of the vaccine 2D barcode 

initiatives. It describes the technical capabilities of EHR/IIS software systems needed to allow providers giving 

immunizations to capture information encoded within the 2D barcode. EHR/IIS software developers should 

use this document as a reference when developing 2D barcode scanning capabilities.

1.2 Scope

This document includes core requirements and use cases that should be incorporated when developing 2D 

barcode scanning EHR/IIS technology. Although the functional capabilities required to capture and process 

the 2D barcode are similar in both the EHR and IIS, there is a primary difference in the purpose of each 

system. While the EHR is intended to be used for vaccine recipient’s vaccine administration and 

documentation, the IIS serves as a system of record that contains complete demographic and immunization 

data for children, adolescents and adults residing or immunized within a jurisdiction. For the purpose of this 

document, the IIS is considered to be used for storing and tracking of immunization data and publicly funded 

vaccines – as defined by the CDC. More assumptions and limitations are also included in this document for 

consideration. This content should be seen as foundational and end-users of the EHR/IIS technology should 

be solicited for additional detailed requirements, as needed. 
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The content of this document is subject to change and will be updated in the future to reflect technological 

advancements and an evolving understanding of EHR/IIS 2D barcode capabilities.

1.3 Audience

This document is intended for EHR/IIS software developers. For decision makers in healthcare centers 

considering implementation of 2D barcode scanning, please refer to the Implementation Guide. 

1.4 Contents

Below is an overview of the organization of this document:

• 2.0 Background Basics: Provides the background on 2D vaccine barcode usage.

• 3.0 Functional Capabilities Overview: Succinctly describes the general business needs and 

requirements that drive the functional capabilities described in Section 4.0: Use Cases. 

• 4.0 Use Cases with Functional Capabilities: Illustrates the distinct use cases that will allow 

developers to understand how vaccine 2D barcoding capabilities will be used.

• 5.0 Functional Capabilities Details: Captures in-depth details regarding each of the functional 

capabilities (see Section 3.0).

• Appendices: Further details background information on the collection of functional capabilities and 

vaccine 2D barcode standards. Developers should refer to the Appendix for additional context.

Barcode Basics 

2.1 2D Barcode Utility

Vaccine 2D barcodes are used to identify vaccine products, Vaccine Information Statements, and Emergency 

Use Authorization Fact Sheets for Recipients and Caregivers. 

Understanding Vaccine Products

Vaccine products are vials of vaccine, intranasal sprays, pre-filled syringes of vaccine, tablets or packets of 

vaccine powder that can be administered to vaccine recipients. Vaccines can be ready-to-administer or 

require mixing, such as when a lyophilized component and diluent are to be mixed just prior to 

administration. 

Unit of Use (UoU) and Unit of Sale (UoS): Pharmaceutical products are packaged in multiple layers. The 

primary packaging refers to the individual usable unit (i.e., ‘UoU’), the secondary packaging is the box or 

package (i.e., the ‘UoS’) that contains multiple UoU products and there is a tertiary layer that can be the 

carton that contains the UoS packages. In this report, we are going to focus on the UoU and UoS; each has 
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distinct product information to support movement along the supply chain and for inventory management 

purposes. 

The Global Trade Item Number (GTIN) is a GS1 product identifier which contains the National Drug Code 

(NDC). GS1 is a standards development organization for barcodes and the NDC is a U.S. Food & Drug 

Administration (FDA) product identifier. The label affixed to the UoS products includes the GTIN, serial 

number, expiration date, and lot number (in human readable form and within the 2D barcode). The Drug 

Supply Chain Security Act (DSCSA)1 requires that 2D barcodes be affixed onto UoS packaging. For vaccines, a 

UoU could be one pre-filled syringe or one drawn dose from a single or multi-dose vial. For vaccines that 

require mixing, as described above, there are typically two UoU products – one for the diluent and one for 

the lyophilized vaccine. The label affixed to the UoU products includes the GTIN, expiration date, and lot 

number (in human readable form and within a 2D barcode). 

As of this document’s publication date, most major vaccine manufacturers are shipping their U.S. products 

with 2D barcodes on the UoU (vial/syringes) product presentations. The list of presentations is updated as 

products are introduced (or retired) and is maintained on the CDC website

(https://www.cdc.gov/vaccines/programs/iis/2d-vaccine-barcodes/index.html). 

Vaccine Information Statements (VISs) 

Vaccine information statements (VISs) provide vaccine recipients with information about vaccines they will 

receive. According to the National Childhood Vaccine Injury Act (42 U.S.C. §300aa-26), immunizers are 

required to provide vaccine recipients a copy of the applicable VIS prior to vaccine administration and are 

required to maintain notation about the VIS edition date and the date the VIS was provided to the vaccine 

recipient.

2

As part of CDC 2D barcoding initiatives, CDC added 2D barcodes containing the Global Document Type 

Identifier (GDTI) to VIS. This 2D barcode is different from the 2D barcodes that may appear on the vaccine 

UoS or UoU, which contain the Global Trade Item Number (GTIN). This technology allows immunization 

providers the ability to scan the code to automatically enter the GDTI and edition date of a VIS document 

into an EHR, IIS, or other electronic database. 

The 2D barcoded VIS are available on the CDC website4

 (https://www.cdc.gov/vaccines/hcp/vis/). As of this 

document’s publication date, all VIS documents contain 2D barcodes.

Vaccine Emergency Use Authorization (EUA) Fact Sheets for Recipients and Caregivers

For each COVID-19 vaccine authorized under an Emergency Use Authorization (EUA), the Food and Drug 

Administration (FDA) requires that vaccine recipients or their caregivers are provided with certain vaccinespecific EUA information to help make an informed decision about vaccination. This is accomplished by 

providing a an EUA Fact Sheet for Recipients and Caregivers. The Fact Sheet is similar in purpose and content 

to vaccine information statements (VISs) for licensed vaccines but differs in that the EUA Fact Sheet is specific 

to each authorized COVID-19 vaccine, is developed by the manufacturer of the vaccine, and is authorized by 

the FDA.
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There is no VIS for COVID-19 vaccines authorized under an EUA. Instead, the FDA-issued EUA Fact Sheet for 

Recipients and Caregivers for each COVID-19 vaccine must be used6

. 

The COVID-19 Vaccine 2D barcoded EUA Fact Sheets are available on the CDC EUA website

(https://www.cdc.gov/vaccines/covid-19/eua/index.html). As of this document’s publication date, all Fact 

Sheets for COVID-19 Vaccines in use contain 2D barcodes. The Fact Sheet is handled similar to a VIS by EHR

systems. 

2.2 2D Vaccine Barcode Symbology 

Information regarding standards for the GS1 DataMatrix symbology, unit of use 2D vaccine barcode 

structure, VIS 2D vaccine barcode structure, and the unit of sale vaccine 2D barcode structure can be found 

in Appendix C. 

Functional Capabilities Overview

3.1 Need

There are three primary use cases that necessitate 2D barcode scanning integration within EHR/IIS systems:

• Scenario 1 – Vaccine Inventory

o 1a – Vaccine Inventory (EHR) 

o 1b – Vaccine Inventory (IIS)

• Scenario 2 – Vaccine Administration

• Scenario 3 – VIS Recording

The functional capabilities that support the transmission of data in these three scenarios are detailed in the 

sections that follow. 

For each use case, the functional capabilities are classified into three areas:

• Monitoring – State of readiness of an EHR/IIS to receive and process incoming data from a scanner

• Processing – Set of actions the EHR/IIS vendors should consider to successfully process data 

contained in 2D barcode of vaccines and VIS. Specifically, these represent actions taken after a 2D 

barcode is scanned and the EHR/IIS has received data from the scanner

• Alerts and Notifications – Warnings displayed to the users upon processing 2D barcodes

3.2 Assumptions and Considerations

This document assumes that users have the hardware necessary to facilitate 2D vaccine barcode scanning. To

facilitate scanning, users require specific scanning devices (and computing devices, if needed) that collect the 

2D barcode data elements. These devices can be handheld or mobile5

. The handheld devices can have corded 

or cordless connectivity. 
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Assumptions and considerations for each of the scenarios are further detailed in the appendix (Scenario 1 – 

Vaccine Inventory, Scenario 2 – Vaccine Administration, and Scenario 3 – VIS Recording).

3.3 Requirements

The table below summarizes the key requirements for integrating 2D barcode scanning with an EHR/IIS 

system for the three scenarios identified above. These are further detailed in the sections that follow.

Table 1: Summary of Functional Capabilities Requirements for 2D Vaccine Barcodes

Scenario 1 – 

Vaccine

Inventory 

Scenario 2 – 

Vaccine 

Administration 

Scenario 3 – VIS 

Recording 

Monitoring

1 Monitor and establish connection with barcode scanner to 

receive 2D vaccine barcode data input from the scanner.

  

2 Recognize scanner connection and 2D barcode data 

input in the module where 2D barcode data scanning 

is expected based on completed configuration of 

scanner.

  

Processing

3 Validate if the barcode is applicable to the EHR/IIS module.   

4 Read the data elements present in the 2D barcode 

string using application identifiers (AI) as defined by 

the GS1 general specifications.

  

5 Use the scanned data to look up other key data about the 

vaccine or VIS.

 
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Scenario 1 – 

Vaccine

Inventory 

Scenario 2 – 

Vaccine 

Administration 

Scenario 3 – VIS 

Recording 

6 If the administration module is connected to an inventory 

module:

• Validate barcode data against the NDC, expiration date, 

and lot number stored in inventory for the samevaccine

• Warn users in the event of missing data ordiscrepancy

• Use all three data elements or a combination to access 

stored inventory data for additional data, such as 

manufacturer and other product information. 

 

7 If the administration module is not connected to an 

inventory module, use the scanned data elements (i.e., NDC, 

expiration date, and lot number) to look up additional 

information about the vaccine, such as manufacturer and 

other product information.



8 Display the scanned data elements and other key data in the 

respective fields.

  

9 Save original scanned values if providing an option to modify 

them.

  

10 Allow users to verify scanned data and manually enter 

additional data that cannot be automatically displayed.

  

11 Provide separate set of VIS fields to capture information for 

each VIS given.


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4.0 Use Cases with Functional Capabilities 

4.1 Scenario 1a – Record vaccine inventory (EHR) 

User Story 

As an inventory manager, I want to record a shipment of vaccines into the EHR system/Inventory 

system, so that I can have an accurate count of the vaccines on-hand. 

System Interaction 

The table below identifies the user system interaction for recording vaccine inventory.

Table 2: Inventory System Interaction

Inventory - System Interaction Table

User EHR

Opens the inventory module Readies to accept scanner data input

Scans 2D barcode from 

vaccine unit of sale * 

Validates if the barcode is applicable to the current EHR module

Reads and populates required fields, such as GTIN, lot number, 

expiration date; and serial number (optional field). 

Accesses mapping tables to look up additional product 

information 

Populates fields with vaccine information

Scans 2D barcode from one 

vaccine unit of use †

Validates if the barcode is applicable to the current EHR module

Reads GTIN/NDC, expiration date, and lot number

Accesses mapping tables to look up additional product 

information 

Populates fields with vaccine information
16

Confirms data populated 

and enters other vaccine 

inventory information, such 

as quantity

-

User submits the inventory record Saves vaccine information to the inventory

 

4.2 Scenario 1b – Record vaccine inventory (IIS)

As an inventory manager, I want to record a shipment of publicly funded vaccines received into the 

IIS so that I can track quantity available and accurately report how they were depleted.

System Interaction 

The table below identifies the user system interaction for recording vaccine inventory.

Table 3: Inventory System Interaction

Inventory - System Interaction Table

User IIS

Opens IIS Readies to accept scanner data input

Scans 2D barcode from vaccine 

unit of sale * 

Validates if the barcode is applicable to the current IIS module

Reads and populates required fields, such as GTIN/NDC, lot 

number, expiration date; and serial number (optional field). 

Accesses mapping tables to look up additional product 

information 

Populates fields with vaccine information

Confirms data populated and 

enters other vaccine inventory 

information, such as quantity

Fields, such as NDC, expiration date, lot number, quantity etc., are 

all populated and validated.
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User submits the inventory record Saves vaccine information to the inventory

 

Functional Capabilities 

The table below lists functional capabilities needed by the EHR/IIS to process vaccine 2D barcode for 

recording vaccine inventory. Please see the Appendix for further information regarding the assumptions and 

considerations, process flow, and functional capabilities details. 

Table 4: Inventory Functional Capabilities (Note: Navigate to the Functional Capabilities Details section by clicking the hyperlinks.)

ID

Functional Capability 

Classification Functional Capability Description

I-M-01 Monitoring Monitor and establish connection with barcode scanner to receive 

2D vaccine barcode data input from the scanner

I-M-02 Monitoring Recognize scanner connection and 2D barcode data input in 

the inventory module where 2D barcode data scanning is 

expected

I-P-01 Processing Validate if the barcode is applicable to the EHR/IIS module

I-P-02 Processing Read the GTIN, expiration date, lot number and serial number† data 

elements from the 2D barcode data string using application 

identifiers (AI) as defined by the GS1 general specifications

I-P-03 Processing Use the scanned data elements* (i.e., NDC, expiration date, and lot 

number) to look up other key data about the vaccine, such as 

manufacturer and product information (i.e. product name or dose)

I-P-04 Processing Display the NDC, expiration date, and lot number and other key 

data in the respective fields* 

I-P-05 Processing Save original scanned values if providing an option to modify them

I-P-06 Processing Allow users to verify scanned data and manually enter additional 

inventory data that is specific to the scanned product and cannot 

be automatically displayed
18

ID

Functional Capability 

Classification Functional Capability Description

I-P-07 Processing Reformat expiration date from the 2D vaccine barcode according to 

the default settings configured for the EHR/IIS

I-P-08 Processing Update mapping and reference data on a regular basis

I-AN-01 Alerts and Notifications Notify users when a barcode is not identifiable

I-AN-02 Alerts and Notifications Warn users that an expired vaccine has been scanned

†Note: In the case that the unit of use 2D vaccine barcode is scanned, the following elements will be read 

from the scan: GTIN, expiration date, and lot number. There is no serial number on the unit of use.

*Note: The availability of 2D barcodes on the UoS packaging should be considered when developing 

EHR/IIS vaccine inventory capabilities. Users may choose to scan the unit of sale packaging for inventory 

purposes. When ordering new vaccines providers typically use the unit of sale NDC.

Acceptance Criteria 

The vaccine products are accurately recorded into the EHR/IIS inventory module. 

4.3 Scenario 2 – Record vaccine administration (Administration)

User Story 

As an immunizer, I want to record a vaccine administration in the EHR system, so that the vaccine 

recipient’s record will be updated with the relevant vaccine data elements.

System Interaction 

The table below identifies the user system interaction for recording vaccine administrations. 
19

Table 5: Administration System Interaction

Administration - EHR/IIS Interaction Table

User System

Navigates to vaccine recipient

administration screen

Readies to accept scanner data input

Scans 2D barcode from vaccine 

unit(s)* of use 

Reads GTIN/NDC, expiration date, and lot number

Accesses mapping tables/inventory information to look up 

additional product information

Populates fields with vaccine information

*Some vaccines contain a lyophilized component and a diluent

component.

Confirms data populated 

and enters other 

administration information

-

User submits the 

administration record

Saves administration information to the EHR (If 

applicable) 

Updates vaccine quantity in inventory

- The EHR directly reports vaccine administration 

data to the IIS †

Functional Capabilities 

The table below lists functional capabilities needed by the EHR to process vaccine 2D barcode for recording 

vaccine administrations. Please see the Appendix for further information regarding the assumptions and 

considerations, process flow, and functional capabilities details. 
20

Table 6: Administration Functional Capabilities (Note: Navigate to the Functional Capabilities Details section by clicking the 

hyperlinks.)

ID Functional Capability 

Classification

Functional Capability Description

A-M-01 Monitoring Monitor and establish connection with barcode scanner to receive 

vaccine 2D barcode data input from the scanner.

A-M-02 Monitoring Recognize scanner connection and 2D barcode data input in the 

administration module where 2D barcode data scanning is 

expected.

A-P-01 Processing Validate if the barcode is applicable to the EHR module.

A-P-02 Processing For UoU: Read the GTIN/NDC, expiration date, and lot number data 

elements from the 2D barcode data string using application 

identifiers as defined by the GS1 general specifications. Some 

vaccines may have more than one unit of use (vaccines with diluent 

and lyophilized components).

A-P-03a Processing If administration module is connected to an inventory module:

• Validate barcode data against the NDC, expiration date, and 

lot number stored in inventory for the samevaccine

• Warn users in the event of missing data ordiscrepancy

• Use all three data elements or a combination to access stored 

inventory data for additional data, such as manufacturer and

other product information

A-P-03b Processing If the administration module is not connected to an inventory 

module, use the scanned data elements (i.e., NDC, expiration 

date, and lot number) to look up additional information about 

the vaccine, such as manufacturer and other product 

information.

A-P-04 Processing Display the NDC, expiration date, and lot number and other key 

data in respective fields.
21

ID Functional Capability 

Classification

Functional Capability Description

A-P-05 Processing Save original scanned values if providing an option to modify 

them.

A-P-06 Processing Allow users to verify scanned data and manually enter additional 

administration data that are specific to the scanned product and 

cannot be automatically displayed.

A-P-07 Processing Reformat expiration date from the vaccine 2D barcode according 

to the default settings configured for the EHR. 

A-P-08 Processing Update mapping and reference data on a regular basis.

A-P-09 Processing When the administration module is connected to an inventory 

module, decrement the inventory count according to the 

vaccine(s) administered.

A-P-10 Processing Administered vaccine data captured via scanner should have an 

‘scan confirmation’ indicator. 

A-AN- 01 Alerts and Notifications Notify users when a barcode is not identifiable.

A-AN- 02 Alerts and Notifications Warn users that an expired vaccine has been scanned.

A-AN- 03 Alerts and Notifications Validate the scanned vaccine against the vaccine recipient

medical record for accuracy.

A-AN- 04 Alerts and Notifications When the administration module is connected to an inventory 

module, warn users if the vaccine is not present in the inventory.

A-AN- 05 Alerts and Notifications Warn users that a recalled vaccine has been scanned.

†Note: In most cases, vaccine administration data will report directly from the EHR to the IIS. In the event 

that users have to manually update the IIS with the vaccine administration data, the same EHR

Administration functional capabilities may be applied to the IIS directly.
22

Acceptance Criteria 

The vaccine product is accurately recorded in the vaccine recipient’s EHR record and users are alerted if the 

scanned vaccine should not be administered based on expiration dates or recalls.

4.4 Scenario 3 – Record Vaccine Information Statements (VIS)

User Story 

As an immunizer, I want to record a VIS information prior to administering the vaccine, so that the 

vaccine recipient’s EHR record is updated with the document code and edition date of the VIS.

System Interaction 

The table below identifies the user system interaction for recording VIS.

Table 7: VIS System Interaction

VIS - EHR Interaction Table

User System

Opens the vaccine 

administration/VIS screen

Readies to accept scanner data input

Scans 2D barcode on VIS Validates if the barcode is applicable to the current system module 

Reads VIS document type and edition date

Accesses mapping tables to look up additional VIS information 

Populates fields with VIS information

Confirms data populated and 

enters other information related 

to VIS

-

User submits the VIS record Saves VIS information to the vaccine recipient’s record
23

Functional Capabilities 

The table below lists functional capabilities needed by the EHR to process vaccine 2D barcode for recording 

VIS. Please see the Appendix for further information regarding the assumptions and considerations, process 

flow, and functional capabilities details. 

Table 8: VIS Functional Capabilities (Note: Navigate to the Functional Capabilities Details section by clicking the hyperlinks.)

ID

Functional Capability 

Classification Functional Capability Description

V-M-01 Monitoring Monitor and establish connection with barcode scanner to receive 

vaccine 2D barcode data input from the scanner.

V-M-02 Monitoring Recognize scanner connection and 2D barcode data input in the 

administration module where 2D barcode data scanning is 

expected.

V-P-01 Processing Validate if the barcode is applicable to the EHR/IIS module.

V-P-02 Processing Read the document code and edition date from the 2D barcode data 

string using application identifiers (AI) as defined by the GS1general 

specifications.

V-P-03 Processing Use scanned data elements, i.e., VIS document code and edition 

date, to look up additional information about the VIS.

V-P-04 Processing Display the VIS document type, edition date in the respective 

VIS fields.

V-P-05 Processing Save original scanned values if providing an option to modify them.

V-P-06 Processing Allow users to verify scanned data and manually enter additional 

VIS data.

V-P-07 Processing Provide separate set of VIS fields to capture information for each 

VIS given.

V-P-08 Processing Reformat edition date from the VIS barcode according to the 

default settings configured for the EHR/IIS.
24

ID

Functional Capability 

Classification Functional Capability Description

V-P-09 Processing Update mapping and reference data on a regular basis.

V-AN-01 Alerts and Notifications Notify users when a barcode is not identifiable.

V-AN-02 Alerts and Notifications Warn users when a more recent VIS is available.

V-AN-03 Alerts and Notifications Validate that the VIS matches the vaccine administered. Warn users if 

a discrepancy exists.

Acceptance Criteria 

The VIS document code and edition date are accurately recorded into the EHR and users are alerted if a more 

recent VIS is available. 

5.0 Functional Capabilities Details

5.1 Scenario 1 – Record Vaccine Inventory (EHR/IIS)

The sections below detail the assumptions and considerations, process flow, and functional capabilities for 

recording vaccine inventory. To return to the section in the main document click here. 

5.1.1 Inventory Assumptions and Considerations

When 2D barcodes on vaccine unit of use are scanned

When scanning in to the EHR, users currently must open the unit of sale to inventory and scan vaccines at the 

unit of use level. To leverage 2D barcodes on vaccine unit of sale packaging, EHR must have a NDC –unit of 

sale to unit of use mapping feature. To facilitate this ability, CDC established and maintains a table that maps 

unit of use to unit of sale packaging NDC relationships: 

www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=ndc.

IIS records inventory by entering or scanning only the 2D barcode on the UoS. Inventory management in the 

IIS is intended for the purpose of tracking publicly funded vaccines from order request and shipment to 

reconciling depletion. Inventory scanning at the unit-of-sale is ideal. The DSCSA requirement for

manufacturers to affix 2D barcodes on the unit of sale was enacted, so all sale packages of vaccines should 

have scannable 2D barcodes. 
25

When 2D barcode on unit of sale is scanned

In the event that mapping between unit of use and unit of sale NDC is in place, the functional capabilities to 

process the 2D barcode will be similar to processing the 2D barcode on unit of use packaging. The primary 

difference will be the recording process. Per the DSCSA requirements, the UoS barcode includes the serial 

number of the product that is not included in the UoU barcode. This extra information would have to be 

taken into account when using the scanner to record data from the UoS barcode. It is not a required data 

element to map between UoS and UoU; however, the additional information in the data string will need to 

be addressed. In addition, the EHR solution should be able to track the quantity of unit of use in alignment to 

the NDC on the vaccine unit of sale. 

When inventory module is absent or inventory is populated by staff

EHR may not always have an inventory module, or some providers may not have opted to enable an optional

inventory module with their EHR/IIS. As a result, the EHR/IIS may be limited to tracking vaccine 

administration only and not contain the functionality to maintain inventory information, such as quantity of 

vaccines. Additionally, for immunization providers using IIS to track and maintain vaccine inventory 

information, the IIS staff may pre-load vaccine inventory into the IIS for the immunization provider. In both 

instances, functional capabilities for the Inventory scenario are not applicable.

User should verify scanned data elements

Users should always verify scanned data, such as NDC, lot number, and expiration date, displayed on the 

screen against the information printed on the label. This will help in identifying label misprints or barcode 

encoding errors before the vaccine information is saved in the inventory module. In addition to the user 

performing the verification, the EHR/IIS should also have the necessary logic to verify barcode data to the 

extent possible. An example of barcode data verification is the determination that the data encoded 

complies with the GS1 2D DataMatrix data structure.

To return to the section in the main document click here. 
26

5.1.2 Inventory Process Flows 

EHR Inventory Management Process Flow 

IIS Inventory Management and Reporting Process Flow 

 

In the inventory process flows depicted in Figure 1, processing of 2D barcodes begins with the receipt of new 

vaccine products and the scanning of the 2D barcode on the vaccine unit of sale and unit of use (or unit of 

sale only for IIS). After completing scanner configuration, the scanner reads the barcode and transmits the 

Figure 1: Inventory Process Flows
27

barcode data string to the EHR/IIS for processing. Configuration details the programming for the scanner to 

read and map data elements into the correct data fields within the EHR/IIS. Additional details can be found in 

Section I-M-01. As a prerequisite to this activity, a scanner must be connected to the computer and a 

connection between the EHR/IIS and the scanner must be established in order to receive and process data.

After receiving the data, the EHR/IIS reads the vaccine information, such as GTIN/NDC, lot number, serial 

number (if used) and expiration date, found in the vaccine 2D barcode. The EHR uses these data elements to 

look up reference tables for additional information about the vaccine product. The reference tables map 

vaccine product to manufacturer and other relevant information for inventory so that the EHR/IIS can 

populate this information automatically. For EHRs, these tables can be purchased files that the EHR vendor 

acquires and loads into the system or that the EHR and/or site can build out. After looking up the NDC, lot 

number, expiration date, and supporting information, the EHR/IIS displays the vaccine information and the 

user verifies the data. After confirmation, the user enters quantity of vaccines and other relevant inventory 

information that is not populated (e.g. date vaccine shipment was received) automatically and submits the 

record, which is then saved by the EHR/IIS.

Once the record is submitted, the EHR can automatically decrements administered doses from active 

inventory as vaccines are being administered (if the EHR administration module is connected to the inventory 

module). In contrast, vaccine decrementing in the IIS is carried out through different processes depending on 

technical capabilities. Some IIS are capable of automatic decrementation if the EHR administration module is 

connected to the IIS inventory module via electronic data exchange or other methods, while other IIS

systems require users to manually decrement during the inventory management and reconciliation process 

or once a UoS vaccine package has been completely used. The inventory management and reconciliation 

process in the IIS includes manually documenting wastage, returns, transfers, administrations, etc.

To return to the section in the main document click here. 

5.1.3 Inventory Functional Capabilities Details

The sections below detail the functional capabilities for recording vaccine inventory. To return to the section 

in the main document click here. 

Monitoring Functional Capabilities

I-M-01: Monitor and establish connection with barcode scanner to receive 2D vaccine barcode data input 

from the scanner.

When a 2D barcode is scanned, the EHR/IIS must be capable of receiving and processing the data coming 

from the scanner. The EHR/IIS must monitor, detect, and establish a connection with the scanner attached to 

the computer. After a connection between the scanner and the EHR/IIS is established, the EHR/IIS must be 

able to detect incoming data from the scanner. Configuration of the scanner will be necessary prior to 

attempting to scan a barcode in order to detect data and route it to the proper fields within the EHR/IIS. 

Configuration refers to the programming of the scanner to read the data contained in the barcode and map 
28

to the relevant EHR fields. This process will vary based on the type of scanner and of the EHR/IIS used to 

scan.

Note: 2D barcode scanners are generally known to interact with computers over different interface protocols 

(modes). One such protocol is the Human Interface Device (HID) mode. A scanner configured in HID mode 

interacts with a computer in the same way a keyboard does. Incoming data from the scanner are accepted by 

the computer as if they are coming from a keyboard. As a result, EHR/IIS that require scanners to be 

configured in HID mode for interaction may not find this functional capability, i.e., to monitor for scanner 

connections and data input, applicable since the operating system software of the computer may handle this 

functionality on its own.

I-M-02: Recognize scanner connection and 2D barcode data input in the inventory module where 2D 

barcode data scanning is expected.

The EHR/IIS must have a connection established and be able to accept data input from the scanner in the 

inventory module of the EHR/IIS where scanning is expected. Specifically, this refers to the EHR/IIS window or 

screen of the inventory module where data scanned from the 2D barcode are to be applied. If this screen or 

window is not open or the user is interacting with a screen where scanning is not expected, the EHR/IIS may 

choose to ignore the data input from the scanner.

To return to the section in the main document click here. 

Processing Functional Capabilities

I-P-01: Validate if the barcode is applicable to the EHR/IIS module.

After scanning the barcode, the EHR/IIS receives data from the scanner, the EHR/IIS must validate if the 

barcode data are valid and applicable to the current window or screen of the inventory module.

The EHR/IIS should check for the presence of Application Identifiers (AIs) to validate that the barcode 

conforms to GS1 standards. Each 2D barcode should contain an AI preceded by a function character (FUNC 

1), which indicates it is following the GS1 standard format. If the AIs are not present in the 2D barcode string, 

it is another indication that the barcode scanned is not a GS1 2D vaccine barcode. Web link for resources on 

the GS1 AIs can be found in Appendix D

Using the AIs, the EHR/IIS must then determine if the barcode applies to the current screen. This check is to 

differentiate vaccine barcodes from VIS barcodes and other barcodes that may be scanned. If data from the 

2D barcode are not applicable to the EHR/IIS, the EHR/IIS should notify the user of the incompatibility.

I-P-02: Read the GTIN/NDC, serial number, expiration date, and lot number data elements from the UoS 2D 

barcode data string using application identifiers (AIs) as defined by the GS1 general specifications.

Data contained within the vaccine 2D barcode are transmitted to the EHR/IIS as a series of characters. Using 

the AIs and the length of the data elements as specified by GS1 standards, the EHR/IIS must read GTIN/NDC, 

expiration date, and lot number as separate data elements for processing. The GTIN data element should be 

processed further to extract the embedded NDC.
29

Additionally, the EHR/IIS should read the entire lot number from the barcode data string. Some EHR/IIS 

leverage the initial characters of a lot number to direct the user interface (UI) focus to the first instances of 

lot numbers with the same initial characters. Reading the entire lot number from the data string ensures the 

EHR/IIS considers all active lots to identify a match and avoid inaccurate association of the scanned lot with 

an existing lot.

I-P-03: Use the scanned data elements, i.e., NDC, serial number, expiration date, and lot number, to look 

up other key data about the vaccine, such as manufacturer and other product information.

Vaccine data other than NDC, lot number, and expiration date must be looked up using reference data. 

Reference data may be stored in tables within the EHR/IIS or accessed via third-party sources. The reference 

tables must provide a mapping of vaccine NDCs to their associated product and manufacturer information, as 

well as to upstream data elements, such as CVX and CPT codes. Reference tables should not be limited to the 

associated information specified here. Utilizing mapping tables to look up additional information about the 

product enhances both the user experience and vaccine recipient safety by reducing the time spent entering 

vaccine information manually, and by reducing the possibility of errors due to manual data entry.

I-P-04: Display the NDC, expiration date, and lot number and other key data in the respective fields.

The EHR/IIS must populate scanned data elements, such as NDC, expiration date, and lot number, and all 

additional information (accessed via reference tables) into their respective fields automatically without user 

intervention.

I-P-05: Save original scanned values if providing an option to modify them.

At times, 2D barcoded data must be modified. It was confirmed during the pilot that if a vaccine is left out of 

a storage unit, such as the refrigerator, for a brief period, providers may shorten the expiration date of the 

vaccine based on manufacturer input. Considering this practice, EHR/IIS should provide an option to modify 

scanned values. If providing this option, the EHR/IIS must also store original scanned values as they appear in 

the 2D barcode and ask the user to enter a reason for modifying the scanned value.

Note: When the original 2D barcode data of a vaccine are modified during inventory, the same vaccine may 

not find a match in the inventory during administration if the EHR/IIS tries to verify it against the inventory. 

The EHR/IIS must consider this potential mismatch when trying to verify vaccines against the inventory 

during administration.

I-P-06: Allow users to verify scanned data and manually enter additional inventory data that are specific to 

the scanned product and cannot be automatically displayed.

EHR/IIS must allow users to verify scanned data and enter additional information about the vaccine that is

not accessible via reference tables or automatically populated by the EHR/IIS, such as date of administration.

Note: Users should always verify vaccine information populated in their respective fields against information 

printed on the vaccine label to catch any label misprints or barcoding errors before the vaccine is 

inventoried.
30

I-P-07: Reformat expiration date from the vaccine 2D barcode according to the default settings configured 

for the EHR/IIS.

The expiration date in the vaccine 2D barcode string is formatted YYMMDD. Before displaying the expiration 

date on the screen, it must be reformatted according to the user setting for the date configured in the 

EHR/IIS. Some vaccines may encode “00” as the day segment of the expiration date. Some vaccine 

manufacturers employ this practice when the vaccine does not include a day on the vaccine human readable 

expiration date. If the EHR/IIS identifies “00” as the day of the expiration date, the EHR/IIS should replace the 

“00” with the last date of the month noted in the expiration date.

I-P-08: Update mapping and reference data on a regular basis.

If the EHR/IIS leverages reference tables, either purchased files or created by the system, to look up and 

populate additional information about the vaccine that are not contained in the barcode (such as 

manufacturer and product name) then these tables must be updated regularly to reflect modifications or 

additions of new vaccine information. We recommend that EHR/IIS vendors incorporate a reference data 

refresh process into their existing EHR/IIS update procedures to address this capability.

To return to the section in the main document click here. 

Alerts and Notifications

For each of the capabilities addressing alerts and notifications, EHR vendors may choose from different 

notification cues, such as pop-up windows, visual indicators on the screen, and sound notifications, according 

to the needs and specifications of the user.

I-AN-01: Notify users when a barcode is not identifiable.

When a scanned barcode is not identifiable according to GS1 standards for vaccine 2D barcodes, or the 

information contained in the barcode is not applicable to the screen in which it is scanned, users must be 

notified of the barcode incompatibility or inappropriate.

I-AN-02: Warn users that an expired vaccine has been scanned.

When a vaccine is found to be expired when logging it into inventory, the user must be notified before 

allowing the user to continue saving the vaccine to the inventory.

I-AN-03: Warn users that a recalled vaccine has been scanned.

When a vaccine is found to be recalled during inventory, the user must be notified and the EHR must allow 

the user to take the necessary follow-up actions. The EHR must leverage the recalled vaccine reference table 

to check the vaccine against and notify the user accordingly.

To return to the section in the main document click here. 
31

5.2 Scenario 2 – Record Vaccine Administration

The sections below detail the assumptions and considerations, process flow, and functional capabilities for 

recording a vaccine administration. To return to the section in the main document click here. 

5.2.1 Administration Assumptions and Considerations

Administration module may or may not be connected to an inventory module

The administration module of an EHR may or may not be connected to an inventory module. Similarly, the IIS 

vaccine inventory management functionality may or may not be connected to the administration module in 

order to decrement administered doses. This distinction is made while addressing the functional capabilities 

for this scenario.

Assumed inventory module terminology

When an associated inventory module exists, the functionality of the module may vary from one EHR/IIS to 

another and may not be referred to as the “inventory module.” In the Administration scenario, the term 

“inventory module” refers to the EHR/IIS component that maintains and tracks the quantity of vaccine 

available to the health care professional for administration.

EHR/IIS can record both lyophilized and diluent (or adjuvant and vaccineμ

) components of vaccine

For reconstituted vaccines with a lyophilized and a diluent component that need to be mixed prior to vaccine 

administration, the EHR/IIS should have the functionality to scan and capture data for both barcodes. It is 

recommended that an EHR/IIS provide fields that allow for scanning data from multiple separate UoU—one 

for each component—in order to ensure information about what is administered is captured completely and 

accurately.

μ

In the past during pandemic events, some vaccines required the mixing of the vaccine with an adjuvant 

at the point of vaccine administration. If this would ever be necessary in the future, the adjuvant could 

be entered in the second or diluent field.” 

User should verify scanned data elements

Users should always verify scanned data, such as NDC, lot number, and expiration date, displayed on the 

screen against the information printed on the label. This will help in identifying label misprints or barcode 

encoding errors before the vaccine is administered. In addition to the user performing the verification, the 

EHR/IIS should also have the necessary logic to verify barcode data to the extent possible, such as 

confirmation of a valid date.

2D barcode is scanned before vaccine is administered

We strongly recommend that a vaccine 2D barcode scan occur prior to administration. Scanning prior to 

administration permits necessary verification steps to help ensure vaccine recipient safety prior to vaccine 
32

administration. This scenario assumes that the 2D barcode on the vaccine is scanned prior to administering 

the vaccine to the vaccine recipient. 

Reporting of vaccine administration data to the IIS

In most cases, vaccine administration data will report directly from the EHR to the IIS. In the event that users 

have to manually update the IIS with the vaccine administration data, the same EHR Administration 

functional capabilities may be applied to the IIS directly, although the IIS may need different data elements as 

they do not function as a patient care system. 

To return to the section in the main document click here. 

5.2.2 Administration Process Flow

 

The process flow depicted above for processing 2D barcodes during administration is similar to the inventory 

scenario with two main differences:

1. The EHR/IIS should update the inventory module if it is connected to the administration module.

2. The EHR/IIS should look up additional vaccine product information from inventory as needed when 

an inventory module is connected to the administrationmodule.

Processing of 2D barcodes begins when the user scans the 2D barcode on the vaccine unit of use before 

administering the vaccine to the vaccine recipient. The scanner reads the barcode and transmits the barcode 

data string to the EHR/IIS for processing. As a prerequisite to this activity, a scanner must be configured, 

Figure 1: Administration Process Flow
33

connected to the computer and a connection between the EHR/IIS and the scanner must be established in 

order to receive and process data.

After receiving the data, the EHR/IIS reads the GTIN/NDC lot number, and expiration date found in the 

vaccine 2D barcode. The EHR/IIS uses these data elements to look up reference tables for additional 

information about the vaccine product. The reference tables map the vaccine product to the manufacturer 

and other relevant information for administration so that the EHR/IIS can populate this information 

automatically. After looking up the NDC, lot number, and expiration date, and supporting information, the 

EHR/IIS displays the vaccine information and the user verifies the data. 

After confirmation, the user enters any administration information not populated automatically and submits 

the record, which is then saved by the EHR/IIS. 

Where applicable, the EHR/IIS updates the inventory module according to the quantity of vaccine 

administered.

To return to the section in the main document click here. 

5.2.3 Administration Functional Capabilities Details

The sections below detail the functional capabilities for recording a vaccine administration. To return to the 

section in the main document click here. 

Monitoring Functional Capabilities

As stated earlier in the document, the Monitoring functional capabilities are the same for the Inventory, 

Administration, and VIS scenarios. Refer to section 5.1.3 for details of Monitoring functional capabilities.

To return to the section in the main document click here. 

Processing Functional Capabilities

A-P-01: Validate if the barcode is applicable to the EHR/IIS module

After scanning the barcode, the EHR receives data from the scanner, the EHR must validate if the scanned 

data are valid and applicable to the current window or screen of the administration module.

The EHR should check for the presence of AIs to validate that the barcode conforms to GS1 standards. If the 

AIs are not present in the 2D barcode string, then it is an indication that the barcode scanned is not a vaccine 

2D barcode. Information about the GS1 AIs can be found in Appendix C. 
34

Using the AIs, the EHR must then determine if the barcode applies to the current screen. This check is to 

differentiate VIS barcodes from vaccine barcodes or other barcodes that may be scanned. If data from the 2D 

barcode are not applicable to the EHR, the EHR should notify the user of the incompatibility.

Note: There may be an instance where the EHR may accept and process 2D barcode data from the vaccine 

unit of use and VIS on the same screen. In this case, barcode differentiation should be used to process and 

display barcode data according to the barcode type scanned.

A-P-02: Read the GTIN/NDC, expiration date, and lot number data elements from the 2D barcode data 

string using application identifiers (AIs) as defined by the GS1 general specifications.

Data contained within the vaccine 2D barcode are transmitted to the EHR as a series of characters. Using the 

AIs and the length of the data elements as specified by GS1 standards, the EHR must read GTIN/NDC, 

expiration date, and lot number as separate data elements for processing. The GTIN data element should be 

processed further to extract the embedded NDC.

The EHR should read the entire lot number from the barcode data string. Some EHR leverage the initial 

characters of a lot number to direct the user interface (UI) focus to the first instances of lot numbers with the 

same initial characters. Reading the entire lot number from the data string ensures the EHR considers all 

active lots to identify a match and avoid inaccurate association of the scanned lot with an existing lot.

For reconstituted vaccines, each of the elements’ barcodes may be read. For example, the lyophilized 

component and the diluent would each have their own GTIN/NDC, expiration date, and lot number to read.

A-P-03a: If the administration module is connected to an inventory module.

1. Validate barcode data against the NDC, expiration date, and lot number stored in inventory for the 

same vaccine, or vaccine component

2. Warn users in the event of missing data ordiscrepancy

3. Use all three data elements or a combination to access stored inventory data for additional data, 

such as manufacturer and other productinformation

If the administration module is connected to an inventory module, the EHR/IIS must first check to determine 

if the scanned vaccine lot exists in inventory. To do this, the EHR/IIS validates the NDC, expiration date, and 

lot number from the vaccine 2D barcode against vaccine information stored in inventory. If the inventory 

does not contain the scanned vaccine, or if there is a discrepancy, user notification should occur. If there is 

no discrepancy and a valid match is found in the inventory, the EHR/IIS leverages vaccine information stored 

in the inventory to populate the fields on the screen.

Because the NDC on the unit of sale and NDC on unit of use differ, a mapping table must be used if only unit 

of sale NDCs are populated in inventory. In addition, it should be noted that lot numbers are not required to 

be consistent between unit of sale and unit of use; in approximately 10% of vaccines, they differ. In these 

instances, a mismatch may display.
35

Any additional information about the vaccine must be looked up using reference tables. Access the reference 

tables similar to the process described in the Inventory scenario.

A-P-03b: If the administration module is not connected to an inventory module, use the scanned data 

elements (i.e., NDC, expiration date, and lot number) to look up additional information about the vaccine, 

such as manufacturer and other product information.

If the EHR does not have an inventory module, then the system must look up vaccine data other than NDC, 

lot number, and expiration date using reference data. Reference data may be stored in tables within the 

EHR/IIS or accessed via third-party sources. The reference tables map vaccine NDCs to associated information 

including, but not limited to, product and manufacturer information, as well as to upstream data elements, 

such as CVX and CPT codes.

Utilizing mapping tables to look up additional information about the product enhances the user experience 

and vaccine recipient safety by reducing the time spent entering vaccine information manually and by 

reducing the possibility of errors due to manual data entry.

A-P-04: Display the NDC, expiration date, and lot number and other key data in the respective fields.

The EHR must populate the Administration screen with scanned data elements, such as NDC, expiration date, 

and other additional information (accessed via reference tables) into their respective fields automatically 

without user intervention.

A-P-05: Save original scanned values if providing an option to modify them.

If the EHR/IIS provides an option to modify the scanned values, the EHR/IIS should also store the original 

scanned values as they appear in the 2D barcode and ask the user to enter a reason for updating the scanned 

value.

A-P-06: Allow users to verify scanned data and manually enter additional administration data that are 

specific to the scanned product and cannot be automatically displayed.

EHR/IIS must allow users to verify scanned data and enter additional information about the vaccine that is 

not accessible via reference tables or automatically populated by the EHR/IIS.

Note: Users should always verify vaccine information populated in their respective fields against information 

printed on the vaccine label to catch any label misprints or barcoding errors before the vaccine 

administration.
36

A-P-07: Reformat expiration date from the vaccine 2D barcode according to the default settings configured 

for the EHR/IIS.

The expiration date in the vaccine 2D barcode string is formatted YYMMDD. Before displaying the expiration 

date on the screen, it must be reformatted according to the user setting for the date configured in the 

EHR/IIS. Some vaccines may encode “00” as the day segment of the expiration date. Some vaccine 

manufacturers employ this practice when the vaccine does not include a day on the vaccine human readable 

expiration date. If the EHR/IIS identifies “00” as the day of the expiration date, the EHR/IIS should replace the 

“00” with the last date of the month noted in the expiration date.

A-P-08: Update mapping and reference data on a regular basis.

If the EHR/IIS leverages reference tables to look up and populate additional information about the vaccine, 

then these tables must be updated regularly to reflect modifications or additions of new vaccine information. 

It is recommended that EHR/IIS vendors incorporate a reference data refresh process into their existing 

EHR/IIS update procedures to address this capability.

A-P-09: When the administration module is connected to an inventory module, decrement the inventory 

count according to the vaccine(s) administered.

If the administration module of the EHR/IIS is connected to an inventory module, then the EHR/IIS should 

automatically update the quantity in the inventory for the vaccine administered.

A-P-10: Administered vaccine data captured via scanner should have a ‘scan confirmation’ indicator.

Data that is captured via a scanner must be indicated in the database or data repository. This indicator 

should not be displayed on the screen to the users. This will allow confirmation that scanners are being used 

and will allow further analysis of that subset of data, if necessary.

To return to the section in the main document click here. 

Alerts and Notifications

For each of the capabilities addressing alerts and notifications, EHR vendors may choose from different 

notification cues, such as pop-up windows, visual indicators on the screen, and sound notifications, according 

to the needs and specifications of the user.

A-AN-01: Notify users when a barcode is not identifiable.

When a scanned barcode is not identifiable according to GS1 standards for vaccine 2D barcodes, or the 

information contained in the barcode is not applicable to the screen in which it is scanned, the user must be 

notified of the barcode incompatibility.
37

A-AN-02: Warn users that an expired vaccine has been scanned.

When a vaccine is found to be expired at the time of administration, the user must be notified to take 

necessary follow-up actions.

A-AN-03: Validate the scanned vaccine against the vaccine recipient medical record foraccuracy.

The scanned vaccine must be validated against the vaccine recipients record to ensure it is correct. To 

enhance vaccine recipient safety, the validation can be made against closed-loop medication administration 

protocol that identifies the five rights of medication administration (i.e., right recipient, right drug, right dose, 

right route, and right time) and/or a Clinical Decision Support System (CDSS) that indicates whether the 

vaccine is needed or contraindicated. A few examples of such validations are as follows:

• Validate if the vaccine is scheduled to be given to the vaccine recipient on the day it is scanned

• Validate vaccine against vital signs and lab values

• Validate vaccine against age requirements for thevaccine

• Check if the vaccine recipient is allergic to thevaccine

Note: Some of the validations could and should be performed earlier in the immunization workflow, such as 

when the vaccine is ordered for the vaccine recipient. If not, then these validations should be performed at 

the time of scanning the 2D barcode during administration.

A-AN-04: When the administration module is connected to an inventory module, warn users if the vaccine 

is not present in the inventory.

If the administration module is connected to an inventory module, then the EHR/IIS must check to determine 

if the vaccine is present in the inventory and warn the user if it is not. The EHR/IIS must have the user enter 

the vaccine into the inventory before administering it.

A-AN-05: Warn users that a recalled vaccine has been scanned.

When a vaccine is found to be recalled during administration, the user must be notified and the EHR must 

provide steps to take necessary follow-up actions. The EHR must leverage the recalled vaccine reference 

table to check the vaccine against and notify the user accordingly.

To return to the section in the main document click here. 

5.3 Scenario 3 – Record VIS

The sections below detail the assumptions and considerations, process flow, and functional capabilities for 

recording VIS. To return to the section in the main document click here. 
38

5.3.1 Assumptions and Considerations

When an EHR does not have the capability to generate VIS

Some EHR may have the functionality to select VIS based on the vaccine administered. When administering a 

vaccine, the appropriate VIS is printed and handed out to the vaccine recipient. The EHR also updates the 

vaccine recipient record with the VIS information, such as publication date. This functionality avoids the 

possibility of outdated VIS forms living in distant offices, and obviates the need for 2D barcode scanning of 

the forms. The functional capabilities in this scenario address EHR that do not have this functionality, and 

require health care professionals to manually select and print the VIS document to be given to the vaccine 

recipient. 

VIS is scanned before vaccine is administered

This scenario assumes that the VIS is given to the vaccine recipient before the vaccine is administered. 

According to the National Childhood Vaccine Injury Act (42 U.S.C. §300aa-26), immunizers are required to 

provide vaccine recipients a copy of the applicable VIS prior to vaccine administration. Scanning of the 2D 

barcode on the VIS is assumed to happen before the VIS is given to the vaccine recipient. 

User should verify scanned data elements

Users should always verify scanned data, such as VIS document name and edition date, displayed on the 

screen against the information printed on the VIS. This will help in identifying label misprints or barcode 

encoding errors before the vaccine is administered. In addition to the user performing the verification, the 

EHR should also have the necessary logic to verify barcode data to the extent possible.

To return to the section in the main document click here. 
39

5.3.2 Recording VIS Process Flow

The process flow depicted above for processing 2D barcodes for VIS is similar to Inventory and 

Administration. The difference in VIS scenario is the data elements in the VIS 2D barcode. Instead of 

GTIN/NDC, expiration date, and lot number, VIS 2D barcodes consist of the VIS document code and edition 

date.

Processing of 2D barcodes begins when the user scans the 2D barcode on the VIS before giving it to the 

vaccine recipient. The scanner reads the barcode and transmits the barcode data string to the EHR for 

processing. As a prerequisite to this activity, a scanner must be connected to the computer and a connection 

between the EHR and the scanner must be established in order to receive and process data.

After receiving the data, the EHR reads the VIS document code and edition date in the VIS 2D barcode. The 

EHR uses this data to look up reference tables to access additional information about the VIS, such as VIS 

document name and edition status. The VIS document data, along with the additional information looked up, 

are displayed on the EHR screen for the user to verify and confirm.

After confirmation, the user submits the record, which is then saved by the EHR. 

To return to the section in the main document click here. 

5.3.3 Functional Capabilities Details

The sections below detail the functional capabilities for recording VIS. To return to the section in the main 

document click here. 

Figure 2: VIS Process Flow
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Monitoring Functional Capabilities

As stated earlier in the document, the Monitoring functional capabilities are the same for the Inventory, 

Administration, and VIS scenarios. Refer to section 5.1.3 for details of Monitoring functional capabilities.

To return to the section in the main document click here. 

Processing Functional Capabilities

V-P-01: Validate if the barcode is applicable to the EHR module

After the barcode is scanned and the EHR receives data from the scanner, the EHR/IIS must validate if the 

barcode data are valid and applicable to the current window or screen of the inventory module.

The EHR should check for the presence of Application Identifiers (AIs) to validate that the barcode conforms 

to GS1 standards. If the AIs are not present in the 2D barcode string, it is an indication that the barcode 

scanned is not a VIS document. Information about resource for the GS1 AIs can be found in Appendix C 

Using the AIs, the EHR must then determine if the barcode applies to the current screen. This check is to 

differentiate vaccine barcodes from VIS barcodes and other barcodes that may be scanned. If data from the 

2D barcode are not applicable to the EHR, the EHR should notify the user of the incompatibility.

V-P-02: Read the document code and edition date from the 2D barcode data string using application 

identifiers (AI) as defined by the GS1 general specifications.

Data contained within vaccine 2D barcodes are transmitted to the EHR as a series of characters. Using the AIs 

and the length of the data elements, as specified by GS1 standards, the EHR must read the VIS document 

code and edition date as separate data elements for processing.

V-P-03: Use scanned data elements, i.e., VIS document code and edition date, to look up additional 

information about the VIS.

Vaccine data other than the VIS document code and edition date must be looked up using reference data. 

Reference data may be stored in tables within the EHR or accessed via third-party sources. The reference 

tables map the VIS document code to associated information, including but not limited to, VIS document 

name and edition status. Utilizing mapping tables to look up additional information about the VIS enhances 

the user experience and vaccine recipient’s safety by reducing the time spent entering additional VIS 

information manually and by reducing the possibility of errors due to manual data entry.

V-P-04: Display the VIS document type, edition date, and other key data in the respective VIS fields.
41

Some EHR require a checkbox to confirm that the VIS was given to the vaccine recipient, while others require 

data entry in the EHR after a hard copy of the VIS has been given to the recipient. If the EHR provides an 

option to scan a 2D barcode, the EHR must populate the VIS screen with scanned data elements such the VIS 

document code, edition date, and additional information (accessed via reference tables) into their respective 

fields automatically without user intervention.

V-P-05: Save original scanned values if providing an option to modify them.

If the EHR provides an option to modify the scanned values, the EHR should also store the original scanned 

values as they appear in the 2D barcode and ask the user to enter a reason for updating the scanned value.

V-P-06: Allow users to verify scanned data and manually enter additional VIS data.

EHR must allow users to verify scanned data and enter additional VIS information that cannot be 

automatically populated by the EHR. 

Note: Users should always verify VIS information populated in their respective fields against information 

printed on the VIS to catch any label misprints or barcoding errors before the VIS is given to the vaccine 

recipient. 

V-P-07: Provide separate set of VIS fields to capture information for each VIS given.

There are instances where more than one vaccine is administered to a vaccine recipient and a VIS (or set of 

VIS documents) is given to the vaccine recipient for each vaccine administered. Additionally, in the case of 

combination or multi-component vaccines, a VIS for each of the vaccine components is given for the vaccine 

administered. For example, if the Hep A-Hep B vaccine is administered, the provider may provide the 

Hepatitis A vaccine VIS and the Hepatitis B vaccine VIS. Conversely, one of the VIS documents, the Multi 

Pediatric Vaccines VIS, contains information related to the following vaccines: DTaP, Hib, Hepatitis B, Polio, 

and PCV13. This VIS could be used for any combination of these vaccines. In this case, one VIS document 

would suffice for multiple administered vaccines. The EHR must provide a set of VIS fields to capture 

information, such as the VIS document name, document code, and edition date, etc., for each VIS document 

given to the vaccine recipient. Stated another way, the EHR/IIS should allow for the capture of multiple VIS 

documents for a single injection. The number of VIS fields provided should correspond to the number of VIS 

documents that should be handed out, which may be higher than the number of injections given if 

combination or multi-component vaccines are included in the visit. In brief, one vaccine could give rise to 

multiple VIS documents and one VIS document, Multi Pediatric Vaccines VIS, is related to multiple vaccines.

V-P-08: Reformat edition date from the VIS barcode according to the default settings configured for the 

EHR. 

The edition date in the vaccine 2D barcode string is formatted YYMMDD. Before displaying the edition date 

on the screen, it must be reformatted according to the user setting for the date configured in the EHR. 
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V-P-09: Update mapping and reference data on a regular basis.

If the EHR leverages reference tables to look up and populate additional information about the VIS, then 

these tables must be updated regularly to reflect modifications or additions of new VIS information. We 

recommend that EHR implementers incorporate a reference data refresh process into their existing EHR

update procedures to address this capability.

To return to the section in the main document click here. 

Alerts and Notifications

For each of the capabilities addressing alerts and notifications, EHR vendors may choose from different 

notification cues, such as pop-up windows, visual indicators on the screen, and sound notifications, according 

to the needs and specifications of the user.

V-AN-01: Notify users when a barcode is not identifiable.

When a scanned barcode is not identifiable according to GS1 standards for VIS 2D barcodes, or the 

information contained in the barcode is not applicable to the screen in which it is scanned, users must be 

notified of the barcode incompatibility.

V-AN-02: Notify users when a more recent VIS is available.

If a more recent version of the VIS document is available at the time of administration, notify the user before 

distributing the VIS document to the vaccine recipient. 

V-AN-03: Validate that the VIS matches the vaccine administered. Warn users if a discrepancy exists.

The VIS scanned must be validated against the vaccine administered to ensure that the correct VIS document 

is handed out to the vaccine recipient. Notify the user of any discrepancy between the vaccine administered 

and the VIS document given to the vaccine recipient. 

To return to the section in the main document click here. 

6.0 Appendices

Appendix A - Methods Used to Gather Requirements

The original methods used to gather the requirements for the functional capabilities guide are documented 

in this section. This section will continue to be updated based on ongoing engagement with stakeholders i.e. 

prior pilot participants, EHR vendors, health systems, pharmacies, professional organizations, etc., in order to 

ensure the information provided within is current.
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Pilots 

In August 2011, the Food and Drug Administration (FDA) finalized guidance allowing vaccine manufacturers 

to apply for a waiver to the linear barcode rule, which opened the door for placing two-dimensional (2D) 

barcodes on unit of use (UoU) vaccine products. Two-dimensional barcodes can capture more data elements 

and occupy less space on the label than a linear barcode. Adding data elements, such as lot number or

expiration date, along with a NDC, would cause a linear barcode to outgrow the space available on many 

vaccine labels. This capability is valuable in the vaccine environment given that the product (vials/syringes) 

are small, the label spacing is limited, and the data requirements for vaccine administration are critical to 

vaccine recipient’s records, registries, and related systems.

As a result, CDC contracted with Deloitte to conduct a pilot project to assess the impact of placing 2D 

barcodes on vaccine products and the ability to improve the accuracy and completeness of immunization 

records.

Concurrently, 2D barcodes were placed on vaccine information statements (VIS). VIS are distributed by 

providers to their vaccine recipients prior to vaccine administration. 

The first pilot data collection period commenced in August 2012 and ended in May 2013. Pilot participants 

included 10 immunization awardees, 220 immunizers (public and private), and two vaccine manufacturers. 

Data was collected from a second pilot conducted between July 2014 and January 2015; this pilot had 7 

immunization awardees, 87 immunizers, and three vaccine manufacturers.

During each pilot, a workflow analysis was conducted at select sites to assess the impact of 2D barcoding at 

the point of immunization delivery and vaccine inventory entry. The purpose of these analyses was to 

develop a comprehensive view of each practice’s immunization process and use this understanding to 

determine how 2D barcode utilization has impacted each practice’s ability to accurately and efficiency 

manage vaccine inventory and administration.

Findings from the first pilot indicated that most EHR and IIS solutions were not yet designed to populate 

fields with information scanned from 2D barcoded vaccines, and few EHR or IIS solutions captured document 

type and edition date scanned from 2D barcoded VIS. There were relatively few 2D barcoded vaccines 

available at the time of this pilot and therefore opportunities to scan 2D barcodes to record vaccine data

were limited.

In September 2013, the second pilot was conducted to expand the work of a previous pilot. In addition to an 

increase in products with 2D barcodes on the market, other settings, such as pharmacies, were becoming

more commonplace for vaccine administration. These developments provided an opportunity to further 

understand the effects of introducing 2D barcode scanning on recording vaccine data. The 2013 pilot focused 

on three primary topics of interest: time savings, data quality, and user experience.
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In January 2016, the third pilot was launched. This pilot continued to monitor 2D barcode adoption across 

the industry. Similarly, the 2016 pilot focused on the following primary topics of interest: the quality of 

vaccine data records, the time to enter vaccine data using scanning and non-scanning entry methods, how 

implementation of scanning occurred across sites within health system, and how staff experienced scanning.

Using observational data, survey data and data direct from the EHRs, these pilots demonstrated increased 

interest in the use of 2D barcodes and perceptions of time savings and improvements in data quality. Both 

were supported through quantitative data analytics. Despite these results, feedback still indicated that 

further adoption may not be achieved until 2D barcoding functionality is fully integrated into EHRs. 

One-on-one Interviews

One-on-one interviews were conducted with EHR vendors to present and discuss three scenarios where 2D 

barcodes can be most useful.

In preparation for these discussions, the pilot team consolidated lessons learned during pilot implementation 

and workflow analysis site visits, and identified three scenarios in practice workflows where vaccine 2D 

barcodes had potential to improve practice efficiency and data completeness and accuracy. Those scenarios 

included recording vaccine inventory (Inventory), vaccine administration (Administration), and vaccine 

information statements (VIS).

To process vaccine 2D barcodes within each scenario, we asked solution architects to consider how and when 

to monitor barcode scanner connections and barcode data, process the barcode data, and provide users with 

associated alerts and notifications. We drafted a list of functional capabilities needed by EHR/IIS software to 

address these considerations for each scenario and shared with five EHR vendors during one-on-one 

interviews. CDC and a Deloitte Advisory Council of EHR and health care industry subject matter experts 

identified the EHR vendors to be consulted. The EHR vendors represented a combination of both hospital and 

ambulatory EHR applications in the marketplace.

For each scenario, we asked EHR vendors to describe their current state, answer questions on the capabilities 

proposed, and provide feedback on the draft practices. In addition, we asked vendors to comment on 

anticipated challenges to implementing such capabilities. 

EHR 2D Barcode Functional Capability Open Forum (Forum)

We held the Forum in conjunction with the Healthcare Information Management Systems Society (HIMSS) 

annual conference and exhibition in New Orleans, Louisiana in 2013. The overall goal of the Forum was to 

share insights with EHR vendors on best practices and future state functionality needed to process vaccine 

2D barcodes. The one-on-one EHR vendor interview feedback was incorporated into a functional capabilities

report draft and was presented to Forum participants. Forum participants were asked for feedback on the 

Functional Capabilities list presented. Forum participants agreed with the majority of functional capabilities 

on the list.
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Post Forum One-on-one Discussions

After the Forum, we conducted five additional one-on-one discussions to help further develop the Functional 

Capabilities list. Input from those discussions is reflected in this Functional Capabilities report along with the 

initial one-on-one interviews.

Ongoing discussion with Providers

Following the completion of the first pilot (2D), ongoing discussions and communications were held with 

providers, including pharmacies, via calls and interviews directly with the sites, discussion panels at 

conferences (e.g. American Pharmacists Association), and via surveys to gain an understanding of perception 

and need in functional capabilities of the electronic systems. Feedback was reviewed and incorporated based 

on frequency of notation and feasibility to be achieved within the systems.
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Appendix B - Factors Influencing Implementation

During one-on-one Interviews, the Forum, and Post Forum one-on-one discussions, most EHR/IIS vendors 

indicated the following challenges and factors that they believe would influence implementing 2D barcode 

capability in their software.

• Customer demand – An increase in requests from immunization provider customers who want to 

take advantage of 2D barcodes on vaccines is a driving motivation for most EHR vendors to 

implement the capabilities. It was noted that the perception of the adoption of EHR by immunizers is 

still in its early stages. Scanner costs are a major factor that affect provider interest in requesting 2D 

barcode capabilities.

• Regulations –Meaningful Use requirements continue to be a high priority for most EHR vendors. 

Most EHR vendors have stated that time and resources are focused on implementing Meaningful Use 

requirements. Any similar initiatives will influence EHR vendor priorities when considering adopting 

2D barcode capabilities.

• Current software capabilities – The capabilities within the current version of a provider’s EHR

software influence the level of changes required to bring the software up to 2D barcode capabilities. 

Some providers have customized solutions for their workflow, which creates a technical environment 

that makes upgrading the software capability challenging.

• Reference Data for NDC Mapping – There is limited public availability of NDC mapping data, such as 

unit of sale to unit of use NDC, unformatted NDC (without dashes) to formatted NDC (with dashes) 

and NDC to manufacturer code. Data should exist in a format easy to download and process from a 

central location to EHR/IIS vendors influences the extent to which mapping tables can be leveraged 

to look up additional information about vaccines and reduce manual data entry.
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Appendix C - 2D Barcode Standards 

GS1 DataMatrix Symbology

GS1 DataMatrix is the 2D barcode type used on vaccine unit of use products and VIS documents. A detailed 

application guideline was prepared by the American Academy of Pediatrics (AAP) and GS1 US to assist the 

U.S. healthcare vaccine industry by providing the current best method for printing and scanning GS1 

DataMatrix on vaccine packages for use at point-of-care. It is based on the GS1 General Specification and was 

developed using information obtained from members of the healthcare supply chain from manufacturers to 

immunizers. 

Unit of Use: 2D Vaccine Barcode Data Structure

In this document, unit of use refers to the container (i.e., vial or syringe) that contains the vaccine and carries 

the label. This is also referred to as the primary packaging. The 2D barcodes placed on vaccine units of use 

and scanned into vaccine inventory and administration records contain three data elements: Global Trade 

Item Number (GTIN), expiration date, and lot number. Figure 4 displays an example of the 2D barcode data 

string encoded on vaccine units of use products. Figure 5 displays the National Drug Code (NDC) embedded 

in the GTIN. NDC is a unique, three-segment number which serves as a unique identifier for drugs. 

Figure 3: 2D Vaccine Barcode Data String - Contains the GTIN, expiration date, and lot number
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VIS 2D Barcode Data Structure

The 2D barcodes placed on VIS contain the VIS Global Document Type Identifier (GDTI) document code and

the edition date. Figure 6 displays the 2D barcode data string printed at the bottom of each VIS.

Figure 4: Global Trade Identification Number (GTIN) with embedded National Drug Code (NDC)

Figure 5: Global Document Type Identifier (GDTI) on VIS; Parentheses are for human-readable consumption and do not appear in the 

string
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Unit of Sale: 2D Vaccine Barcode Structure – Drug Supply Chain Security Act (DSCSA) 

Unit of sale refers to the immediate container or packaging that 

holds the unit of use. This is also referred to as secondary 

packaging. Title II of the Drug Quality and Security Act (DQSA), 

also referred to as the Drug Supply Chain Security Act (DSCSA), 

requires vaccine manufacturers to affix 2D barcodes to vaccine 

unit of sale packaging. 

The 2D barcode required includes a standardized numerical 

identifier (SNI) in addition to the GTIN, expiration date, and lot 

number. Serialized 2D barcodes help enable product verification, which helps to identify potentially 

compromised vaccine products (i.e., recalled, contaminated, or counterfeit product) within the supply chain. 

Serial numbers are sometimes found within the 2D barcode on the unit of sale and need to be accounted for 

in the interpretation of the scan and configuration of scanner to health system; currently, serial numbers do 

not need to be recorded or monitored per guidance from the American Immunization Registry Association’s 

Standards and Interoperability Steering Committee (SISC). An explanation of the data elements contained 

within the UoS barcode is shown in Figure 7 (from the February 27, 2017, AIRA/CDC Notice to the IIS 

Community: Serial Numbers in Unit of Sale 2D Barcodes).

Figure 6: Example of New UoS 2D Barcoded Vaccine Data String

The 2D barcode on unit of sale is expected to be used primarily in inventory management; for most systems, 

the inventory management module is a separate, but integrated, module to the vaccine recipient vaccine 

administration modules. For the purposes of this document, scanning the UoU 2D barcode is recommended 

for vaccine administration.
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To return to the section in the main document click here. 
51

Appendix D - Useful Resources

Below are useful reference resources:

• IIS: NDC Lookup Crosswalk

http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=ndc 

• Other Code Sets (e.g., CPT to CVX, Product Name to CVX, MVX, CPT to CVX, etc.) 

http://www.cdc.gov/vaccines/programs/iis/code-sets.html 

• VIS and EUA Fact Sheets for Recipients and Caregivers Lookup Table

https://www.cdc.gov/vaccines/programs/iis/code-sets/vis-barcode-lookup-table.html 

VIS Reference List http://www.cdc.gov/vaccines/hcp/vis/current-vis.html

• EUA Fact Sheet for Recipients and Caregivers Reference List 

https://www.cdc.gov/vaccines/covid-19/eua/index.html

• FDA’s National Drug Code Directory

https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory

• FDA’s Recalls 

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/default.htm
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Appendix E - References

1. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA)

2. GS1 General Specifications

3. GS1 Healthcare ImplementationGuideline

4. VISs

5. COVID-19 EUA Fact Sheets for Recipients and Caregivers

6. Bell C, Atkinson KM, Guerinet J, Wilson K, Feasibility and Limitations of Vaccine Two-Dimensional 

Barcoding Using Mobile Devices, J Med Internet Res 2016;18(6):e143