Two-Dimensional (2D) Vaccine 

Barcoding Pilot 

Education Forum Report

The 2D Vaccine Barcoding Pilot is funded by the Centers for Disease Control and Prevention (CDC) and managed under 

contract by Deloitte Consulting, LLP (Deloitte). A contract to design and implement the barcoding pilot was awarded to 

Deloitte in September 2011.

"Reviewed November 2014"
Contents

Contents........................................................................................................................................................ 2

Executive Summary...................................................................................................................................... 4

Background................................................................................................................................................... 6

Forum Objectives ......................................................................................................................................... 6

Forum Agenda .............................................................................................................................................. 6

Speaker Presentations................................................................................................................................. 10

The 2D Barcode History and Progress.................................................................................... 10

Elizabeth Sobczyk, AAP – Manager, Immunization Initiatives AAP..................................... 10

2D Barcode Technology.......................................................................................................... 11

Paul Robinson, Deloitte........................................................................................................... 11

2D Barcoding Pilot.................................................................................................................. 12

Dr. Erin Kennedy, CDC, NCIRD/Immunization Services Division, Medical Officer............ 12

2D Barcode Pilot: Lessons Learned and Early Findings......................................................... 14

Marshall Gaddis, Deloitte........................................................................................................ 14

VIS Overview.......................................................................................................................... 17

Ken Gerlach, CDC - NCIRD/Immunization Services Division, Health Scientist................... 17

Workflow Analysis.................................................................................................................. 18

Andrew Sharpin, Deloitte........................................................................................................ 18

Panel Discussions....................................................................................................................................... 20

Discussion Panel 1: Inventory Management and Workflow Benefit ...................................... 20

Discussion Panel 2: EMR/IIS Overview-Progress and Updates ............................................. 25

Working Sessions....................................................................................................................................... 31

Group 1 – Standards................................................................................................................ 31

Group 2 – Adoption................................................................................................................. 34

Group 3 – Implementation....................................................................................................... 37

Summary and Recommendations............................................................................................................... 39

Summary ................................................................................................................................. 39

Themes .................................................................................................................................... 39

Recommendations................................................................................................................... 39

Appendix A – Speaker Presentations ......................................................................................................... 41

Appendix B – Attendees............................................................................................................................. 42

Appendix C –Breakout Groups.................................................................................................................. 45

 [2] 

Appendix D – Top Challenges Suggested by Forum Registrants .............................................................. 46
Appendix E –Evaluation Feedback Results................................................................................................ 47

Appendix F – Resources........................................................................................................................... 54

 [3] 
Executive Summary

The 2D Vaccine Barcode Pilot's (Pilot) Education Forum (Forum) was conducted April 14-15, 2013, at 

the Intercontinental Hotel in New Orleans, LA. Seventy eight (78) immunization community 

stakeholders including vaccine manufacturers, immunization program awardees, public and private 

immunizing providers, and electronic medical record (EMR) vendors, Immunization Information System 

(IIS) staff, and 2D barcode scanner vendors met to discuss the lessons learned from the Pilot (to date), 

opportunities, challenges and next steps for the adoption of 2D barcoded vaccines.

The Forum was structured to provide information on critical topics for the industry, as suggested by the 

immunization community and Pilot participants. Discussion revolved around insights from the Pilot; 

early lessons learned and associated challenges, information to assist with clinical adoption and use of 2D 

barcodes and discussions regarding EMR and IIS maturity and capability to consume and use 2D 

barcoded data

The Forum opened with presentations that emphasized that, while indicators point to adoption of 2D 

vaccine barcoding, more work needs to be done including considering next pilot stages, future roadmap 

items, and strategies to move forward. The discussion progressed to an overview of 2D barcode history 

and progress presented by an American Academy of Pediatrics (AAP) representative. 

The Forum included presentations on the 2D barcode technical foundation and an overview of the Pilot. 

Lessons learned and early findings from the Pilot were presented based on preliminary evaluations of 

Pilot data, which led to discussing the expanded application of implementing 2D barcodes on Vaccine 

Information Statements (VIS). Day 1 of presentations concluded with an overview and findings of a 

workflow study performed at a subset of Pilot provider sites. 

The focus of Day 2 of the Forum was to connect the immunization stakeholders together and create an 

understanding of their individual roles, needs, and barriers to adoption that should be removed for 2D 

barcoded vaccine adoption. The second day of the Forum opened with two panel discussions, one 

focused on Inventory Management and Workflow, and the second panel, focused on EMR/IIS capability 

overview and progress. The panel discussions were followed by working group sessions with Forum 

attendees to discuss the benefits and impacts of 2D vaccine barcoding. Topics for the breakout working 

sessions were standards, adoption, and implementation. 

Working sessions revealed a plethora of feedback, recommendations, and clarifications in understanding 

surrounding the adoption and use of 2D barcoding in the vaccine community. Key points gathered from 

the working sessions: 

· Adding 2D barcodes to the vaccine product secondary package (saleable unit, i.e. carton) was a 

big topic of discussion. Doing so will benefit inventory management easing a path to adoption 

and implementation. 

· The GTIN, lot number, and expiration date currently found in the 2D barcode on vaccine units 

of use should be aggregated at the secondary package level. In the future, also add serial 

numbers to the secondary and tertiary (unit of service/unit of sale) packaging. 

 [4] 
· GTIN, NDC, and lot number crosswalks are needed to identify the relationships between 

primary and secondary packaging of vaccine products labeled with 2D barcodes. 

· Reconstituted vaccines with one or more active components use unique NDCs for each 

component, which presents additional complexities when considering adding 2D barcodes to the 

outer or secondary package. 

· Manufacturers, providers, and EMR/IIS solutions do not agree on a standard on which NDC 

and lot number should be encoded in the 2D barcode on a secondary or tertiary package. 

Further investigation and work are needed to establish standards and implementation guidelines.

· Data capture and processing standards are needed to guide EMR and IIS vendors how to 

process 2D barcodes currently found on vaccine product units of use as well as those 2D 

barcodes that may be found on secondary packaging in the future. 

· The widespread adoption of scanning 2D vaccine barcodes should be promoted with a 

structured, national, organized approach. Clear initiative leadership, documented guidance, and 

cohesiveness between partners are needed in order to succeed. 

· Practitioners and manufacturers are largely ready to adopt 2D barcoding.

The Forum concluded with a summary of progress to date and recognition of challenges remaining for 

full 2D barcoded vaccine implementation. Several points surfaced during Forum discussions were 

highlighted to emphasize the importance of 2D barcode implementation to the vaccination community. 

Meeting contributors were acknowledged and there was a general agreement that continued collaboration

is required to facilitate 2D barcoded vaccine adoption.

 [5] 
Background

In September 2011, CDC initiated a 2D vaccine barcoding pilot project to assess the effect of 2D 

barcoding technology on the completeness and accuracy of immunization information. 

The 2D Vaccine Barcode Pilot's Education Forum (Forum) was organized to bring together the 

immunization community stakeholders including vaccine manufacturers, immunization program 

awardees, public and private immunizing providers, and electronic medical record (EMR) vendors, IIS

staff, and scanning vendors to discuss the lessons learned from the Pilot (to date), opportunities, 

challenges and next steps for implementing 2D barcoding on vaccine products. A full list of attendees is 

displayed in Appendix B.

Forum Objectives

The Forum was designed and structured to bring immunization community members together to discuss 

opportunities and challenges presented by the introduction of 2D barcodes on vaccine products. Forum 

objectives were to share insights from the CDC 2D Barcode Vaccine Pilot, early lessons learned and 

associated challenges, to provide information to assist with clinical 2D barcode adoption, and discuss 

Electronic Medical Record (EMR) and IIS functional applications of 2D barcode abilities. This was 

accomplished through speaker presentations and panel discussion. Attendees were engaged in working 

groups to determine where opportunities, gaps, and challenges to 2D adoption exist and determine how 

to best collaborate to move the industry forward. 

Forum Agenda

Day 1 of the forum included presentations on 2D barcoding history, technology, and insights gained

during the CDC 2D Barcode Vaccine Pilot. Day 2 was dedicated to collaboration, proving panel 

discussions and breakout working sessions. Panel discussions shared insight from immunization industry 

representatives experienced with 2D barcode vaccine application. Breakout working sessions facilitated 

discussion around 2D barcoded vaccine adoption, implementation, and standards. 

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Table 1 – Education Forum Agenda

 [7] 

Day 1

Day 1: April 14, 2013

Time Description Presenter

1:30-1:40 PM

10 minutes

Welcome and Introduction

· Welcome

· Objectives of Forum

· Agenda

· Antitrust

Warren Williams, MPH

CDC—

NCIRD/Immunization 

Services Division, 

Informatics Team 

Lead, Immunization 

Information Systems 

Support Branch

1:40 – 2:10 PM

30 minutes

The 2D Barcode History and Progress

· History of barcoding at AAP –driving factors

· AAP vision

· How 2D barcoding supports AAP vision

· Scanner guidance issued 

· Next steps for AAP

Elizabeth Sobczyk

AAP

2:10 – 2:30 PM

20 minutes

2D Barcode Technology 

· Overview of 2D barcode structure

· Overview of scanners and capabilities

· Other considerations

Paul Robinson

Deloitte 

2:30 – 3:00 PM

30 minutes

2D Barcoding Pilot 

· Background and structure

· Participants – Awardees, Immunizers, 

Manufacturers

Erin Kennedy, DVM, 

MPH

CDC—

NCIRD/Immunization 

Services Division, 

Medical Officer

3:00 – 3:15 PM Break 15 minutes

3:15 – 3:45 PM

30 minutes

2D Barcode Pilot – Lessons Learned and Early 

Findings

· Lessons learned – Scanners, Data entry 

models, EMRs, Linear barcodes, End to end 

supply chain

· Early pilot findings - accuracy and 

completeness impact

Marshall Gaddis

Deloitte

3:45– 4:00 PM

15 minutes

VIS Overview

· Overview of VIS 

· What is GDTI and how will placing on VIS be 

valuable

· Progress in transitioning VIS statements 

· FAQs and Lessons learned

· Where we go next? Vision?

Ken Gerlach, MPH, 

CTR

CDC—

NCIRD/Immunization 

Services Division, 

Health Scientist
 [8] 

Day 1

4:00 – 4:20 PM

20 minutes

Workflow Analysis

· Workflow analysis

· Overview of process

· What were the challenges and what were the 

surprises 

· Key lessons learned that can be built upon

Andrew Sharpin

Deloitte

4:20 – 4:30 PM

10 minutes

Day 1 Close

· Wrap up and overview for Day 2 – extend 

invitation to socialize at scanner booths

Warren Williams, MPH

Day 2: April 15, 2013

Time Description Presenter

7:30 – 8:30 AM Continental Breakfast

9:00 – 9:15 AM

15 minutes

Welcome - Day 2

· Welcome

· Recap of Day 1

· Objectives and agenda for Day 2

Warren Williams, MPH

9:15 – 10:00 AM

45 minutes

Inventory Management and Workflow Benefit 

discussion

· Overview of the supply chain

· Current practices in inventory management

· Current workflow overview

· Where are the opportunities and benefits

· What is the real value and next step

Panel of 4

Jennifer Paster, Sanofi 

Pasteur

Erika Jurrens, 

GlaxoSmithKline

Tara Cullinan, 

Pediatrics for You

Jan Hicks-Thomson, 

WA DOH

10:00 – 10:45 AM

45 minutes

EMR/IIS Overview Progress and Updates

· Role of EMR/IIS vendors in scaling and 

adoption

· Current workflow overview

· Where are the opportunities and benefits

· What is the real value and next step

Panel of 4

Susan Stroud, Pediatric 

Health

Mary Beth Kurilo, 

AIRA/Oregon Alert 

IIS

Wes Baker, Cerner 

Maggie Griscom, 

Mitchell and 

McCormick

10:45- 11:00 Break 15 minutes

11:00 – 11:15 AM Breakout Group Instructions
 [9] 

Day 1

15 minutes · Review objectives of breakouts

· Assignment of people to groups – introduce 

facilitators and scribes

· Overview of templates and review of

questions

· Readout format

· Logistics

Breakout Groups Collaborative Sessions

· Break into three (3) groups to discuss 

challenges to adoption and what is needed to 

accelerate acceptance

· Review questions

· Develop top needs to address in industry and 

what barcodes can and cannot do

· Understand common practices and 

workarounds that may disappear

· Discuss the benefits of barcoding from the 

perspective of providers and registries

· Develop next steps

12:30 – 1:00 Break for Lunch 30 minutes

1:00 – 2:00 PM

60 minutes

Breakout Groups Collaborative Sessions

· Continuation of pre-lunch breakout session

· Finalize materials for readout

2:00 – 3:00 PM

60 minutes

Group Readouts

· Each group will provide details on what they 

discussed

3:00 – 3:30

30 minutes

Day 2 Wrap up and Adjourn

· Thank all participants

· When materials will be available

· Reference barcoding site for future questions 

and education needs

· Help desk and web site resources available

· Working together going forward

· Questions

· Feedback survey distributed

Warren Williams, MPH

11:15 AM –12:30 PM

75 minutes
Speaker Presentations 

Speaker presentations are provided in Appendix A. 

 [10] 

The 2D Barcode History and Progress 

Elizabeth Sobczyk, AAP – Manager, Immunization Initiatives AAP

Elizabeth Sobczyk presented a historical and forward-looking overview of vaccine barcoding.

The key points presented by Ms. Sobczyk: 

· Pediatricians provide the majority of immunization in the U.S.

· AAP partnered with CDC, vaccine manufacturers, and other immunization stakeholders to 

investigate the feasibility and barriers to implementing 2D vaccine barcoding.

· The GS1 DataMatrix 2D standard was agreed upon to barcode vaccine vials and syringes (units 

of use). 

· AAP published clinician and manufacturer resources providing guidance on 2D vaccine barcode 

implementation. 

· Sanofi Pasteur has rolled out seven 2D barcoded vaccine products. GlaxoSmithKline has rolled 

out one and committed to future products (as of the date of the Forum). 

· Future clinician guidance is needed on workflow changes that can leverage decision support 

systems, such as scanning vaccines prior to instead of after administration. 

· Next steps include measures to remove the linear barcode when 2D barcodes are present, 

completely integrate with registries, and roll out 2D barcodes into manufacturers' complete 

portfolios.
2D Barcode Technology 

Paul Robinson, Deloitte 

Paul Robinson provided a technical overview on the standards and structure of 2D barcodes, how they 

differ from linear barcodes, and barcode scanner hardware fundamentals. 

The key points presented by Mr. Robinson:

· 2D barcodes offer higher density data storage than linear barcodes, 2335 alphanumeric characters 

capacity compared to 48 alphanumeric characters available in linear barcode, and requires less 

space, making 2D barcodes a logical choice to carry additional vaccine data elements such as 

product identifier, expiration date, and lot number, which are not stored on vaccine linear 

barcodes. 

· Global Trade Item Number (GTIN) and Global Document Type Identifier (GDTI) are global 

standards developed by GS1 US Healthcare to identify vaccine products and VIS. 

· Scanners typically must be configured by EMR vendors in order to interface with EMR solutions 

and process the 2D barcodes. 

· Additional resources are available from AAP and GS1 for further 2D barcoding guidance and 

specifications. The links to these resources are found in Appendix F. 

Table 2 - Technology Questions and Answers*

 [11] 

Question Answer

Q1 Can you scan linear barcodes if your scanner also 

does 2D?

[Paul Robinson, Deloitte] Yes

[Bonni Kirkwood, Deloitte] It will be important 

to think through how 2D barcoded vaccines not 

only affect EMR vendors but every other system 

that consumes data (payments, adjudication) -

anything important to practices. So when you hear 

about 2D capabilities, think of other systems you 

work with today and how they will consume the 

data as well 

*Questions and Answers captured in this report were not captured verbatim
2D Barcoding Pilot

Dr. Erin Kennedy, CDC, NCIRD/Immunization Services Division, Medical 

Officer

Dr. Kennedy provided an overview of the 2D Vaccine Barcoding Pilot Project, including a description of 

the progress of 2D vaccine barcoding efforts since 2004. 

The key points presented by Dr. Kennedy:

· The National Childhood Vaccine Injury Act requires documentation of data not available on 

linear barcodes and 2D barcodes can capture additional information like expiration date and lot 

number.

· Potential public health benefits of the 2D Vaccine Barcoding Pilot include improved accuracy of

patient health records, consistency in information captured in IIS and VAERS reports, increased 

ability to identify safety concerns and a potential reduction in administration errors.

· The 2D Vaccine Barcoding Pilot’s objectives are to examine the challenges of implementing 2D 

barcodes on vaccines and to evaluate the use of 2D barcodes via assessing data completeness, 

user experience, and process impacts, and to document best practices and lessons learned.

· The Pilot timeline began with manufacturer, IIS, and immunizer enrollment and provisioning 

from late 2011 through mid-2012, continued with immunization tracking through April 2013, 

and will conclude with a final report to summarize findings. 

· Baseline and Learning data sets were collected from awardees and immunizers, and have been 

used to inform early findings. Additional data was collected through a user expectation survey, a 

mid-pilot user experience survey, and a workflow analysis. Additional data is still to be collected 

through a second user experience survey and a third data set, maturity data.

· The Pilot included 2 manufacturers, 10 awardees, and 217 immunizers. The immunizers included 

145 private practitioners, 71 public health departments, and 1 commercial pharmacy. 

· Specific EMR vendors were not targeted for Pilot participation. However, a total of 23 different 

EMR vendors and a number of provider sites entering directly into the IIS were used by 

participating immunizers during the Pilot. 

Table 3 - Pilot Questions and Answers*

 [12] 

Question Answer

Q2 Early in the slides on your history you talked 

about the FDA saying that manufacturers could 

request a waiver and it sounds like there was 

interest in that. Can you talk about if that is 

shifting—fewer manufacturers interested in a 

waiver/moving towards barcoding?

[Erin Kennedy, CDC] Vaccine manufacturers must 

request a waiver if they wish to remove the linear 

barcode from a product. I cannot speak to what

manufacturers are planning. Both vaccine 

manufacturers in the Pilot are currently using linear 

and 2D. 
 [13] 

Question Answer

Q3 I thought that is what the waiver was— It is if 

you are carrying a linear code but you want to take 

it off?

[Erin Kennedy, CDC] Yes, the waiver is only required 

for replacing a linear with a 2D barcode. 

[John Roberts, GS1] Nowhere else is a manufacturer 

doing it beyond what they are doing in the Pilot. We 

do hope that they switch [to 2D barcodes] because of 

all of the benefits we know are there.

Q4 On the very last slide, it looks like there were 

16 sites that did not have an EMR?

[Erin Kennedy, CDC] The 16 sites are public health 

sites, so they were entering data directly into their IIS. 

Erin: R

Q5 Is there comparison data with those public 

health sites?

[Erin Kennedy, CDC] Right now we have just done 

the preliminary analysis, but that suggestion is great 

idea for future analyses.

Q6 Are all of the manufacturers on board with 

this; are they all in the process of doing it? Any 

timelines?

[Erin Kennedy, CDC]GSK and Sanofi are currently 

on board, but that is all I can tell you. 

[Bonni Kirkwood, Deloitte] We have heard in several 

industry events with other manufacturers that many 

are looking at applying 2D barcodes to other products

(not just vaccines). My understanding of the waiver is 

if a manufacturer chooses to remove the linear 

barcode, they will need to apply for a waiver. At this 

time, the FDA has not applied this waiver to the 

broader Pharmaceutical markets, but expanding track 

and trace regulations may make this a possibility. 

Many manufacturers are interested in doing it just a 

matter of funding, priorities, etc.

[Eric Metrokotsas (?), Merck]From the standpoint of

using both linear and 2D on products, it was more of 

a marketing decision to accommodate practitioners 

that don’t have 2D scanning capability - we don’t 

want to limit their ability to use their current scanners. 

We just filed for (Varivax?)

[Erin Kennedy, CDC] RTI interviewed seven vaccine 

manufacturers [during impact study], and all but one 

said they were going to move towards 2D barcodes. 

CDC was not told which these were. RTI report

*Questions and Answers captured in this report were not captured verbatim
2D Barcode Pilot: Lessons Learned and Early Findings 

Marshall Gaddis, Deloitte 

Marshall Gaddis provided an overview of the preliminary lessons learned and early findings during 

analysis and evaluation of the baseline and learning data sets collected from the pilot immunization 

program awardees and immunizing providers. 

The key points presented by Mr. Gaddis: 

Lessons Learned

· Vaccination Data – Analysis of the baseline and learning data provided visibility to several 

vaccination recording practices that presented challenges for which controls were developed to 

enable analysis: 

o

o

o

o

o

o

o

Data contained characters intentionally added by immunizers to the scanned lot number

in order to assign attributes that are defined in separate fields on the user interface 

screen. Stripping out the erroneous characters from the lot numbers revealed increased 

accuracy rates. One example increased accuracy rate from 16% to 97%. 

Data was transferred to the IIS in four different ways creating non-identical data sets. 

Data entered free form yielded many variations of the same information. For example, 

when entering vaccine names instead of picking from a drop down list or other finite set 

of names, more than 100 unique names for the same vaccine appeared. 

· User Experience – Measured with an online instrument: 

The major concern was that a small percent of 2D vaccines were available in the pilot.

Scanning vaccines into inventory presented the additional concern of having to open the 

outer box to scan individual vaccine vials. 

· Analysis Method – Completeness and accuracy are validated by first checking for a non-blank 

field to indicate completeness then comparing values to reference data comprised of distribution 

and manufacturing data. 

Early Findings

· Approximately one million baseline and learning data records were received from provider sites 

and IIS. Of those, an upward trend in the availability of 2D barcoded records emerged as the 

pilot progressed and as more 2D barcoded products entered the Pilot supply chain. 

· The EMR and IIS records received during the baseline and learning phases were compared and 

measured for completeness and accuracy. Both data sets increased in completeness and accuracy 

from the baseline to the learning phase. “EMR and IIS records received during the Baseline and 

Learning phases were compared and measured for completeness and accuracy. Both datasets 

increased in completeness and accuracy of lot numbers from Baseline to Learning. Baseline data 

for both EMR and IIS had over 250,000 records, and Learning data for each had over 650,000

records.

EMR Lot Number completeness went from 93% (Baseline) to 97% (Learning), and 

EMR Lot Number accuracy went from 97% to 99%. 

IIS Lot Number completeness went from 66% to 83%, and IIS Lot Number accuracy 

went from 95% to 97%.”

 [14] 
· IIS data increased even more from 289,000 complete baseline records to 816,000 complete 

learning phase records. Accuracy increased from 192,000 baseline records to 674,000 learning 

phase records.

· Additional analysis is needed to account for seasonality and other confounders such as 

technology gains or motivation levels of sites that are self-selected for this type of pilot study. 

Table 4 - Pilot Findings Questions and Answers*

 [15] 

Question Answer

Lessons Learned

Q7 On the side of the vial displayed in one of the 

slides, there is an L and E shown next to the human 

understandable information. Is that what you actually 

see?

[Bonni Kirkwood, Deloitte] That is the human 

readable - or human understandable - information. 

It is printed so that if there is no technology to 

read the bar code, providers can read the key 

product information. The L and E are there only in 

the human understandable representation to 

denote the L lot, and E expiry date. Manufacturers 

can vary on the human understandable approach 

they use and the field they use to indicate 

expiration, lot or batch etc.

Q8 Over time you would not need the human 

understandable?

[Paul Robinson, Deloitte]Manufacturers will still 

need to provide human understandable field for 

those who are not scanning barcodes. 

[Bonni Kirkwood, Deloitte] If you think about 

the variety of practices, there are some that are 

paper- based and they will not move to an esystem in the near future if ever. Also, need to 

think about global application as well.

Q9 Are the L and E in the barcode? [Paul Robinson, Deloitte] No. The data is 

encoded in the barcode, but not the labels “L” and 

“E”. 

Q10 You mentioned some practices use a P before lot 

number to differentiate vaccines. When you found out 

a practice did it, did you ask why and what it captures? 

[Joe Durbin, McKing] Some Pilot immunizers 

use “HOSP” as an indicator in their system for the 

private funded products as opposed to what is a 

VFC funded product. Different indicators are used 

by different practices, there is not a standard. 

Q10 Did we ask the practices why they thought it was 

important to capture the "HOSP" or the "P" in the 

data cleansing lesson learned?

[Paul Robinson, Deloitte] Some practices use

this indicator to differentiate sites, and some use 

the indicator to differentiate public or private 

purchase vaccines. 

[Joe Durbin, McKing]Practices told the team 

that they needed to keep the indicators for 

accounting purposes.

Q11 Was the variability seen in IIS and EMR? [Marshall Gaddis, Deloitte]We have not looked 

at how many combinations in each. I can say for 

sure that unique values like this come in from 

EMR systems and IIS systems alike, it is not unique 
 [16] 

Question Answer

to a specific data source.

Q13 Yes I understand that, but if they scan lot 

number then they have lost the ability to record that 

element that is important to their practice, so have to 

keep that into account. 

[Paul Robinson, Deloitte] We have observed 

that, in some cases, an EMR has a variable to 

indicate if it was a private or public vaccine - but 

the variable wasn’t selected. Instead, the 

immunizer entered the information in the lot 

number field. 

Q14 Problems with the vaccine name was mentioned -

is that because of NDCs?

[Marshall Gaddis, Deloitte] We used vaccine 

name as another validation point to identify the 

vaccine noted. NDCs themselves are prone to 

errors. Checking NDCs and the vaccine name 

resulted in a stronger match. What we found was a 

significant variability in vaccine names used. 

Standardization of product name is an area of 

opportunity. 

Q15 Are lot codes specifically written for VFC vs. 

Private?

[Audience] No.

User Experience:

Q16 Are an equal number of pilot sites using 2D for 

vaccine administration and inventory?

[Leslie Fierro, Deloitte] No, the smaller number 

of responses could be due to number of sites using 

for each function.

Q17 Were there fewer practices scanning at inventory 

than administration? Could that be the fewer number?

[Leslie Fierro, Deloitte]Yes. Much fewer at 

inventory.

Analysis Methodology

Q18 Is there an opportunity to see how the data is 

exchanged between IIS and provider to see if that is a 

confounder?

[Marshall Gaddis, Deloitte] Yes we will look at 

the difference between IIS and provider 

transference methods to account for differences

Q19 Is there is an opportunity to look at the method 

of data exchange between the EMR and IIS- Struck 

between the completeness and accuracy of data that 

may seemingly be introduced because of the IIS 

specifically. Could that influence the data in some 

way?

Q20 Clarification, look at the transfer of data to the 

IIS to see if that could be why there is a difference 

from the EMR?

[Marshall Gaddis, Deloitte] I don’t think I 

mentioned that earlier. We are going to evaluate 

EMR and IIS separately. We would expect similar 

trends, but we are going to evaluate them 

separately. We will have results for EMR and 

potentially separate results from IIS. 

*Questions and Answers captured in this report were not captured verbatim 
VIS Overview

Ken Gerlach, CDC - NCIRD/Immunization Services Division, Health Scientist

Ken Gerlach provided an overview of the purpose for adding 2D barcodes to VIS, the data standards in 

use for VIS, and the 2D barcode VIS resources available. 

The key points presented by Mr. Gerlach:

§ 2D barcodes were implemented on VIS as part of the Pilot in order to achieve the benefits of

increasing completeness of data elements, enhancing record keeping for providers, and 

promoting the use of barcoding technology.

§ The CDC identified the GS1 Global Document Type Identifier (GDTI) to encode the VIS, 

added the 2D barcode VIS documents recently updated, developed guidance documents for 

users, and published the VIS lookup table online.

§ Providers have an option to use either the multi-vaccine VIS or vaccine-specific VIS for DTap, 

Hepatitis B, Rotavirus, Hib, Polio, and PCV13. 

Table 5 – VIS Questions and Answers*

 [17] 

Question Answer

Q21 Are there plans to get all VIS updated? HIB 

hasn't been updated since 1998.

[Ken Gerlach, CDC] This is a good point. An 

argument could be made to update all of the VIS 

documents to include 2D barcodes without waiting 

for a different VIS update trigger. 

Q22 Is language being captured? Sometimes a 

language other than English has a different date on 

the VIS.

[Ken Gerlach, CDC] The 2D barcode used on an 

English language VIS should be the same one used 

for the same VIS translated into other languages. If 

there is a discrepancy between for the same VIS in 

different languages, it sounds like an error of some 

type. 

Q23 Is there a requirement that VIS must be 

delivered in hard copy? 

[Ken Gerlach, CDC] There is no requirement that 

the VIS be paper based. Copies of the VIS are 

available in RTF file formats for use in electronic 

systems. 

Q24 VIS barcodes are inside a black box, reading 

the barcode is not as snappy as reading a GS1 

DataMatrix outside the little black box. Ease of 

reading the barcodes is important, is there a reason 

for the black box?

[John Roberts, GS1] CDC has actually changed the 

GS1 standard on the Data Matrix -they were one of 

the first US groups to use the GDTI

Q25 Wasn't the box put there to let people know 

this is a business type barcode and can't be used by 

trying to scan a QR code with their phone app?

[Paul Robinson, Deloitte] The black box 

surrounding the Data Matrix is potentially overlapping 

the quiet zone a little at the bottom of the barcode. 

*Questions and Answers captured in this report were not captured verbatim
Workflow Analysis 

Andrew Sharpin, Deloitte 

Andrew Sharpin presented a summary and key findings of the workflow analysis conducted at select pilot 

sites as part of the Pilot. The purpose of the workflow analysis was to develop a comprehensive view of 

each practice’s immunization process to determine how 2D barcode utilization has impacted each 

practice’s ability to accurately and efficiently manage vaccine inventory and administration. Two site visits 

were conducted for each provider site in the workflow analysis study: One visit was before the 

implementation of 2D barcodes and the other visit was after. 

The key points presented by Mr. Sharpin:

· Limited supplies of 2D barcoded vaccines were available. Increasing the number of vaccines 

with 2D barcodes and ensuring that practices are aware of the products that can be scanned will 

improve scanning adoption and increase efficiency gains from scanning.

· The physical location in the provider’s office where the vaccines are documented significantly 

impacts the adoption. Locations within the office, such as the vaccine prep station, the exam 

room, or moving throughout the office with a laptop, dictate proximity to the storage unit, 

scanner storage location and foot traffic, all of which impact scanner availability and user 

adoption.

· The timing of when vaccines are documented significantly impacts user adoption. Documenting 

administrations after vaccines have been given negates the value of using an EMR with clinical 

decision support, which increases the potential for medical errors. The delay in data entry also 

increases the possibility of entering incorrect information.

· EMR integration with 2D barcode scanning improves usability, which increases adoption.

· Data entry efficiency gains will be made by replacing manual data entry with scanner input and 

by reducing the need to correct errors that occur when manually entering product information. 

For example, entering NDC manually is a time consuming step. Scanning NDC would help 

promote the use of scanners.

· Efficiency gains are realized for inventory and administration. Practices using their EMR system 

for inventory management all saw efficiency improvements when scanning 2D barcodes. 

Improvements in vaccine administration efficiency were closely tied to a practice’s experience 

scanning 2D barcoded vaccines.

· Practices are sometimes unaware they have received a product with a 2D barcode until that lot 

becomes active and they open the package. Adding 2D barcodes to the vaccine secondary 

package would expedite the inventory process.

Table 6 – Workflow Analysis Questions and Answers*

 [18] 

Question Answer

Q26 Is using a phone or laptop camera as a way to 

scan possible? 

[Geoff Glaser, BARDA] We have performed 

some testing with cell phones and were unable to 

get a read on 5mil X 5mil, but we could read the 

7mil by 7mil. It appears to be related to the 

pixilation 

[Paul Robinson, Deloitte] The complication with 

using mobile devices is that the scan may work but 

there is no underlying application that will get the 

information back to the IIS or EMR. Unless you 
 [19] 

Question Answer

have that application on your mobile device, the 

data is read but goes nowhere.

Q27 What about the gold standard practice of not 

documenting immunizations until after administered?

[Andrew Sharpin, Deloitte] There are two ways 

of thinking about this, if you scan before 

administration then you can validate that you are 

using the right vaccine, etc. However, there are 

also occasions in which the practitioner goes into 

the room and the parent decides to not to 

vaccinate. 

[Elizabeth Sobczyk, AAP] It would basically be 

a save in draft form, you are just giving the 

opportunity for clinical decision support to 

happen, and save as draft...that is something we 

are going through. 

[Bea Salada, MI IIS] This could affect inventory 

models. 

[Elizabeth Sobczyk, AAP] This is definitely an 

area we are looking into more. Draft form is only 

one means for making that happen.

Q28 I wonder about opening each box of vaccine to 

upload the inventory. Can you say a little about the 

process of manufactures who have barcode on the 

unit of use now – will they have to seek FDA 

approval and is that a barrier?

[Geoff Glaser, BARDA] When referring to 

serialized products there is a difference in the 

FDA requirements between the package and unit 

of use barcoding 

[Erika Jurrens, GSK] As the only company that 

puts 2D barcode on the vaccine box, we do not 

use serialization, we use NDC, we do encode lot

number, expiry. You must understand that the 

NDC on the secondary package is different from 

the primary.

Q29 Are the inefficiencies with EMR receiving 

scanned data because the EMR was not set up to 

receive the information?

[Andrew Sharpin, Deloitte] Most likely but we 

cannot say “yes” across the board. Different 

EMRs process data in different ways. 

Q30 Any discussion with McKesson about their 

processes and putting 2D barcode on the packing slip?

[Paul Robinson, Deloitte] We have not had that 

discussion. We are in the process of finalizing a 

report on the impact of 2D barcoded vaccine on 

supply chain participants that touches on this.

Q31 Focus on 2D barcode on outer package, why 

linear vs.2D barcode?

[Andrew Sharpin, Deloitte] The 2D 

incorporates lot number and expiration date. 

[Max Peoples, RxScan] Longer linear bar codes 

are more difficult for a scanner to read.

[Geoff Glaser, BARDA] The linear bar code will 

become too big (note: linear barcodes grow in 

length as more data is added)

Q32 But on secondary and tertiary, is the size of the 

barcode an issue?

[Geoff Glaser, BARDA] 2D barcode use will be a 

global standard. 

*Questions and Answers captured in this report were not captured verbatim
Panel Discussions

Discussion Panel 1: Inventory Management and Workflow Benefit

Panel members:

· Jennifer Paster, Sanofi Pasteur

· Erika Jurrens, GlaxoSmithKline

· Jan Hicks-Thomson, Washington State

· Tara Cullinan, Pediatrics for You

Moderator: Paul Robinson

Note: The questions in bold are moderator questions. Italicized questions and comments came from the 

audience. Answers from panel members are indicated with the panelist's first name, answers from the 

audience are indicated the full name and organization. The questions and answers captured in this section 

were not captured verbatim.

1. Jennifer and Erika, your companies’ readiness to commit to implementing 2D barcodes on 

vaccines was vital to the feasibility of the 2D barcode pilot. Could you give us a better 

understanding of your experience with the regulatory process to gain approval for 2D 

barcode use on vaccines? 

· Jen- For the regulatory process, we had to submit an FDA Post Approval Study (PAS) to apply a 

2D barcode to a vaccine. Then we had to provide the rationale for the changes we were making, 

including a mock up. The FDA was a good partner; they reviewed our submission over a shorter 

timeframe so that we could get 2D vaccines out to the market in time for the Pilot. Our biggest 

issue was making the changes to the labeling—multiple products, multiple lines, and multiple 

countries. Communication was a key component in the success.

· Erika- I agree with what you said. The 6-month PAS may be a hurdle going forward. That is a 6 

month time period—so if you submitted today 4/15/2013- then you would have 6 months from 

today until you knew this was actually approved. First, there is a full six months before getting a 

green light, then you have all of the production concerns. Once the product is produced, then 

you have to work through existing inventory before the 2D product is to market. This is a much 

longer time to market than the regulatory 6-month review. I would echo that we were very happy 

to be a part of the Pilot. We really feel this is the best for patients and providers. 

Q1.1- Beyond the pilot, are there any additional milestones? Or is this just a situation where you submit for FDA approval 

and just cross your fingers and wait? 

· Erika-Yes, a bit but, because this was the Pilot, we were all learning together. There were some 

experiences we had where we went back and thought we would do it differently. 

· Jen-There is prep work that goes into it, so you want everyone involved in the labeling process to 

be ready. Many of our 2D barcoded vaccines were approved internally prior to the 6-month

approval coming through from FDA.

Q1.2 - Will this be the process for future requests, for future products?

· Jen- My understanding is ‘yes’.

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· Paul- We do not have FDA representation here. There has been no indication that it will be 

different.

Q1.3 - Do you anticipate continuing forward even though the pilot is nearly over? 

· Erika- Yes we are 100% behind barcoding. We believe in its benefit and we understand there is a 

large ask from many. We are really committed to this. 

· Jen- Yes. From Sanofi we have seven vaccines with 2D barcodes, and plan to have the pediatric 

portfolio with 100% 2D barcodes by the end of this year.

Q1.4 - Can you speak to how the barcodes are going to be put on the vials and syringes for those that you have to mix?

· Jen- At a high-level, the FDA did determine that the 2D barcode has to reflect the contents. You 

can either record the outside box or powder component. 

· Erika- Ditto 

2. Costs and production impact are obvious considerations for vaccine manufacturers 

considering 2D barcodes. What are some of the not-so-obvious considerations? 

· Erika- There are more concerns than cap [capitalization] costs. There were a lot of line upgrades 

that were necessary, it can truly be difficult - Tom (attending GSK representative) can talk with 

you about that. I would also point out that we brought Chris (attending GSK representative)

from an artwork perspective. There is very little living space for that barcode, so it is important 

that you can actually scan the barcode once as it is on the product and that the barcodes readable

without taking up too much real estate. At GSK, we decided to put the barcode on the outer box 

as well as the vial. Barcoding on the outer box created some challenges, but we felt it would be 

important for inventory management. With all of the concerns aside, we do feel this is a benefit 

for patients.

· Jen- The only thing I might add is when it comes to production, it isn’t just taking down the 

product lines. There is also a need to do a validation for quality for multiple countries; this can be 

a very big process.

3. The increased data accuracy provided by 2D barcode scanning offers a clear benefit to 

practices that key-in vaccine inventory. Several practices have their vaccine inventories 

loaded by their state immunization registry. Jan's immunization registry in Washington is an 

example. Jan, would you please share about the impact 2D barcode vaccines have had on 

immunization registry vaccine inventory management and workflow? 

· Jan - It hasn’t changed state-level inventory because we load that data in from VTrckS. But, from 

a provider perspective, if the lot scanned matches the lot number in inventory then the 

vaccination data it is more accurate. The process assures the correct lot number, correct 

expiration date and correct NDC are being pulled down from inventory.

· Tara- I agree. We get our vaccine information pre-populated. We don’t have a lot of private 

vaccines in the office. 

4. Does 2D make the reconciliation process a more tightly coupled process?

 [21] 
· Jan- From an overall business perspective, thinking about VFC in the state, there are many other 

benefits. For example, there are several data elements that are required that can be scanned in. If

they are scanned in, it is accurate and clear. Also, yesterday there was a discussion about the VIS 

and recording the publication date of those with 2D scanning. If a practice is using 2D scanning 

to capture VIS data, you may have a higher likelihood that the data is accurate and complete so 

important from that perspective as well. 

Q4.1 You mentioned the NDC number, which version do you use?

· Jan- We use the 5-4-2, the 11 digit version. We upload that data when we process orders.

Q4.2 Do you have trouble getting the 11 digit version in the system since what is barcoded is the 10 digit version? 

· Mike Bin, Washington State - All of our NDCs are managed in a table, so as orders flow out of

the system, the NDC stays with it. When an order is shipped from McKesson, we download the 

file from VTrckS and NDC is still tied.

Q4.3 Do you envision that being practical down the road when there might be overlap between lot numbers from 

manufacturers?

· Paul- That is something 2D barcode can help with 

· Max Peoples, RxScan- But they are tracking the NDC

· Paul- There is potential for relationship tables to map the lot number/NDC combination if the 

information is available. This would be more dynamic than a straight NDC relationship table but 

would provide the NDC/Lot combination which would be unique. 

Q4.4 With regard to inventory management, will there be an auto-trigger to McKesson that we are running low?

· Jan- I think that is beyond a scanning question. We have talked a lot and some states have a 

replenishment model that when inventory reaches a certain level an order is auto-generated. But 

in thinking about the role of scanning, it is more about if the inventory is valid, other pieces of

the system would have to place the replenishment order. 

Q4.5 For providers that have private and public vaccines, how are they indicating which are being used if they are just 

scanning the barcode?

· Jan- Washington is a universal purchase state, so we purchase all vaccines for all children under 

19 years old in the state. With very few exceptions, they are publicly supplied.

· Tara- The only private purchase vaccine that we have is the flu vaccine. We don’t scan the flu 

vaccine yet so I don’t know how that is going to propagate. 

Q4.6 Maybe someone from the audience has experience with this? 

· Mary Beth, Oregon IIS - We use the lot number if there are two products from the same lot. 

From public and private lots, the system will use the dose-level eligibility code to break the tie.

5. Patient safety is a recurring theme in 2D barcoded vaccine discussions. Would you share 

your thoughts on how 2D barcoded vaccine use may enhance patient safety? 

· Tara- I think the most important items were covered yesterday. If we have recall, bad vaccine, or 

expired vaccine. Having that correct number in there makes it much easier for us to call that 

 [22] 
patient and recall everyone who had that lot number. If you enter it manually, you might miss 

some folks. 

· Jan- From a programmatic perspective, we manage all the returns in the state. Programs can 

return spoiled or expired vaccines for an excise tax. One challenge we have is matching the 

return to the product. If a digit is missed or something is hand written about the lot number 

then we have a very difficult time matching back to the product. If that product was one that 

could be returned, then we can’t benefit from excise tax. So 2D scanning can be a real benefit at 

the program level. 

· Jen- If you are thinking more future in terms of EMR and think about the pre-scan process. If

the patient has allergies or if the product is expired, etc. think about the power of capturing that 

before the vaccine is administered to a patient. 

· Erika—this is such a huge initiative. I just want to reiterate that we have had a great relationship 

with the partners and this really has been a learning initiative. I feel very fortunate to be able to 

say we really came together as a group. The manufacturers often get told that we work against 

each other, but we worked together here on patient safety. So we thank everyone. We have really 

enjoyed working together on this project. 

· Jen- Agree. 

Q5.1 If you were asked to respond to a pandemic influenza, how quickly could you respond with adopting a 2D barcode? 

· Jen- It would depend. We have certain lines that are available and ready, assuming FDA worked 

with us on that, we probably could do it. It depends on the volume of product.

· Erika- Right, it is all about priority. 

· Geoffrey Glaser, BARDA—everyone knows it is a priority. Could you work it into 8-12 weeks? 

I’m talking about using it across the board. It doesn’t do much good to have it on the container 

if we can’t use it throughout the system. 

· Jan- I think this really goes back to some conversations yesterday about the potential value of

having linear and 2D. Right now, in Washington State we have the ability to assign a linear 

barcode to a product and can use that so we already have that in IIS. So any clinic we have, that 

capacity is there. It isn’t exactly what you are talking about because it is a specific assignment we 

would make. But if manufacturers can ‘t pursue a 2D barcode at the same time, as the public 

health system, we need to recognize that 2D is not a silver bullet and that it may not be the 

perfect answer for this. 

Q5.2 I don’t know much about McKesson, but I am wondering if you can speak to whether they are involved in this Pilot?

(Role that McKesson played in the pilot)

· Paul- they didn’t have a change in their role in the VFC vaccines. We were able to get source data 

from them that we are using as a reference. So that is their role in the Pilot, business as usual for 

them though. 

· Warren Williams, CDC- We were not able to adjust their existing process as part of the Pilot 

because of large costs, etc. 

· Jan- And I wonder since McKesson is a central distributor and we are talking about practice if

that is necessary. I don’t think we have to change McKesson’s practice. At the state level, it is 

about how we assure the data is getting to IIS and decrementing inventories correctly for use in 

 [23] 
returns, visible for site visits, etc. I don’t really see a critical need for McKesson or other 

distributors to manipulate or change their processes to make this possible. 

· Paul- I agree. There are aspects of their business that will likely need to change for serialization 

but not as much for 2D barcode application to vaccines. 

· Mike Bin, Washington State - I think there may be an important step McKesson needs to play in this. 

When they are receiving bulk vaccines from the manufacturers, someone is hand-keying lot 

information into their system. There needs to be processes in place so they are entering the same 

exact number on the barcode because those are being used to pre-populate the IIS. We have a 

challenge with Sanofi because with IPOL there is a dash. Note: A parking lot was used to table points 

that would require more time to investigate than the agenda allowed. This item was added to the 

parking lot. 

Q5.3 We spoke about inventory and reconciliation. Did you notice any improvement in your inventory reconciliation with 

2D barcoded vaccines, and will you please tell everyone what you told me about how nurses felt about using scanners? 

· Tara- Regarding inventory, I don’t think there was a whole lot of difference. As far as nursing 

staff, we don’t get a lot of 2D vaccines yet. We have two products with the barcode, so when one 

of them comes up, we fight over who gets to scan it. 

Q5.4 Barcodes are great when they are scanned. But when you scan a UPC, and it isn’t in database, it says “not found”. 

How do you accurately get the information from vaccine manufacturers to get it into systems? This is the issue we run into; 

we don’t get the info accurately.

· Paul- This is still in development. We are talking about having a common dataset that is 

published and available and can be pulled down to EMR and IIS systems. 

· John Roberts, GS1- Right, for now folks do a work around, this is one you see at inventory and 

retail, etc. The work around is manual entry by clinicians. 

· Jan- I think that really speaks to the need to have a holistic approach to that. You can’t look at 

these processes in isolation to each other, must make sure that we have accurate inventory. If

McKesson isn’t scanning the lot number, then maybe they can improve that practice (if relying 

on IIS that is pre-populated); if doing your own inventory management at practice, you need to 

have 2D barcodes on the outer box so it can be quickly loaded into inventory.

· Max Peoples, RxScan - Possible solution to that ___ if you scan it and it isn’t in your inventory;

does the system just ask if you want to enter it?

Q5.5 This comes down to a trust issue, how do you get users to trust putting info into that main database?

· Erika- There are published reports of NDCs, for subscription purposes though. Not sure if that 

answers your question?

· John Roberts, GS1 - It does but someone pays for that. The easy answer is you give it to the 

FDA or the CDC to publish it, but they would have to pay for it. But what if the info goes up 

incorrectly? That is the biggest issue we have had on our side. 

· Erika- your point is well taken.

· Paul- And we are considering this. There are data brokerage services that take data and then 

distribute it and charge a fee for it.

· John Roberts, GS1 - It gets even worse with serialization, which is going to be a nightmare. This 

is a tough nut to crack. 

 [24] 
· Jan- The first entity that we trust is CDC, the second that we have to trust is our distributors 

(direct ship and shipped through McKesson); for other states that are not universal, they have to 

trust manufacturers. Also, trust for practices because they have to get data into system accurately. 

But these folks are all very vested in getting accurate information. Everyone wants to make sure 

patients get what they need. There is always going to be work to be done—if you can get to 98% 

accuracy that will be great. The standard cannot be any higher than we set for medical practice.

Discussion Panel 2: EMR/IIS Overview-Progress and Updates

Panel Members:

· Wes Baker, Cerner Corporation

· Mary Beth Kurilo, Oregon IIS/AIRA

· Susan Stroud, Pediatric Health/Ocean Health

· Maggie Griscom, Mitchell and McCormick

Moderator: Paul Robinson

Note: The questions in bold are moderator questions. Italicized questions and comments came from the 

audience. Answers from panel members are indicated with the panelist's first name, Answers from the 

audience are indicated with the full name and organization. The questions and answers captured in this 

section were not captured verbatim.

1. What do you see as some of the key benefits 2D barcode functionality provides to 

immunizers? 

· Susan- When we were doing paper charting we didn’t even know we had a problem, there were 

no red flags, etc. Then we stared online inventory management—we went all-in (we do private 

and public in our practice - more private than public actually in New Jersey). In NEW JERSEY, 

they were moving towards making inventory management required. Andrew touched well on 

efficiency—but efficiency in the reconciliation process is very important and wasn’t mentioned. 

When we moved into online, it was an eye opener. What was on online was not what was in the 

refrigerator. So I started reconciling inventory every two weeks. I spent many, many hours 

reconciling, 2D has really improved this efficiency. Menactra was the first one. After a while I 

didn’t have to look at Menactra anymore because it was correct in the inventory once 2D 

barcoding was introduced and used.

· Mary Beth- Just to underscore everything you say about accuracy, we have been watching data 

come in from about 1,000 providers in Oregon. The 2D plus paying attention to reconciliation 

helps so much with that. 

· Susan- And it helps with accountability because you are accountable to that.

2. What will it take to drive EMR vendors to incorporate functionality?

· Wes- The government and stage 2 meaningful use requirements are key drivers to incorporate 

functionality we offer a full screen so you can use the PC with a tethered or blue tooth scanner. 

We also have an application with Honeywell and Motorola. Also working on Android 

application. There is a need to have mobile capabilities in the workflow. Streamlining is important 

 [25] 
to making the process be accurate, etc. at point of care. I’ve heard a lot of nurses say I’ve never 

made an error—you don’t know until you’ve seen it. 

· Maggie-Barcoding cannot be intrusive into the process, it needs to be streamlined, and it needs 

to integrate into what we are already doing. Our folks have taken the barcoding and implemented 

it directly into inventory, it takes inventory and deducts when they give the vaccine. It triggers the 

fact that they need to give a particular VIS flyer, so they aren’t seeing a new level of technology

interfering with what they are doing when it comes to the patients.

Q2.1 Can you comment on the level of effort it took to get systems up in terms of handling vaccines?

· Wes- We are fully compliant. Once a 2D barcode is scanned, all information is extracted into the 

correct fields and available. 

Q2.2 Any indication what the level of work is with 2D? How does it translate to sweat equity? Years?

· Wes- I wouldn’t say years, probably a 6-month engineering effort. Not a lot of work.

· Maggie- For us, I would say it was fairly simple because we were collecting that information 

already (referring to data elements). Folks in health departments were used to collecting that 

information. It took one developer about one week. For us it was trying to do the same thing we 

do for our folks, just make it as simple as possible using existing processes.

Q2.3 When you say you are fully compliant and ready to go, does that mean you plug in 2D barcode scanners into a PC 

and your EMR just pulls the data in?

· Wes- Yes, that is correct. {Plug- and-play} 

· Paul- I think that won’t be the case with everything, there will be some configuration. 

· Wes- once a scanner is configured it is seamless.

Q2.4 If it is not turnkey, how much time is it going to take? How long to get EMRs to be turnkey because no one is going 

to change their EMR. What about folks who don’t have Cerner or M&M?

· Paul – the answer is “it depends” since this varies by product vendor. It also depends on their 

priorities. So many are focused right now on CMS requirements so it may not be at front of their 

list of enhancements. 

Q2.5 Is there anything for outpatient yet? 

· Paul- A very small number of vendors that specialize in outpatient solutions that have 2D 

barcode capabilities. 

· Wes- those numbers are going to continue to grow. 

Q2.6 How was the business decision made to prioritize barcoding? Was it based on meaningful use?

· Wes- No, we had been doing it for years. 

· David Friedman, Deloitte- it depends on the vendor.

· Maggie- We have customers who wanted it and so we moved it through. 

· Elizabeth Sobczyk, AAP – So if it is customer priority, then is it the customer who pays for it?

· Maggie- Our clientele is all public health departments. 

· Elizabeth, AAP- Once built is it available to all other customers?

 [26] 
· Maggie- Yes.

3. Did you experience any push back from practices?

· Mary Beth - In Oregon, about 90% of data comes in electronically. Providers are very interested 

in 2D, but their concern is getting their vendors to make the change. It is an interesting process. 

We work with practices and vendors to try and triangulate solution. It is an issue of sequencing it 

in with priorities.

· Susan- I agree. We were ready before we heard about this pilot. We had actually discussed this 

idea. I think providers are ready, I have talked to other providers, and I think customer demand is 

there. When required to manage inventory electronically demand will definitely be there.

· Mary Beth- We heard from providers that they were concerned about having two workflows, 

having manual for some and scanning for some. But the providers who are in the practices in the 

pilot actually have said they appreciate 2D benefits even only having even a few vaccines 

barcoded.

· Paul- Maggie any pushback from practices?

· Maggie- No push back beyond cost of scanners. So it became a budgetary issue for them. 

· Paul- I don’t understand the degree of issue that poses. They are about $300 [scanners], so does 

it amount to a large expense?

· Maggie- It depends on the size of the practice. If you have five nurses giving vaccines all day 

every day, can become $1500 to $1600. That becomes a big concern at least for the public 

providers. Sue can probably talk to providers.

· Susan- I do have a take on that. The reconciliation process without the 2D is so challenging 

because of the time it takes. You know errors exist but you don’t know what is wrong, there can 

be hundreds of errors that you have to find and it takes so much time. This is a cost, one that is 

largely removed when 2D is used. 

· Wes- From the hospital perspective, cost is a major issue because many scanners are needed.

Q3.1 In one of yesterday’s presentations, there was mention of a time study, pre and post. One of the larger practices that 

started the pilot and then declined to participate later noted that they would easily pay for a scanner because reconciliation 

takes so much time, so staff labor costs with respect to reconciliation was very high and scanners remove that. 

Q3.2 Have any of you seen one barcode more challenging than others to scan (any variability)?

· Susan- I haven’t noticed any differences between the five we have. 

4. Mary Beth please put on your AIRA hat. Practices are ready they want to move forward but 

in some cases their registries aren’t ready yet. Any guidance you would like to share? 

· Mary Beth- For data coming across an e-feed, the data looks the same at the IIS end. We have 

some difficulties with providers entering into our e-system. We can currently bring in lot number

and expiration date at inventory and administration. But we hit a stumbling block with NDC, 

developing and standardizing NDC at inventory with point of administration. Unless we are 

using the same clean cross walk when decrementing inventory and trying to reconcile in the end. 

But there is still room for disconnect, without the primary and secondary packaging labeled. As 

part of prevention, a public health fund grant exists where a few states are working on a first 

 [27] 

pass of the cross walk with CDC. 
Q4.1 Do you support the notion of registries expanding or just focus on EMR side?

· Mary Beth- Great question,. Ninety ( 90%) of our data in Oregon is coming in from EMRs, but 

only 10% comes directly into the IIS. We have providers who say they will retire or die before 

they take on an EHR, so we probably have to do both to be responsive. 

5. A couple of other questions, with some of the software being pushed out. For Wes and 

Maggie, what did you use for the guidelines for implementation, any standard?

· Maggie- We used the support from the scanner, how the scanner was reading the barcode. I don’t 

know if we used GS1, we just took the information. The hard part for us was the translation 

from the barcode into the system to ensure the data went into the right places. But it was the 

developer who did this. He just took the codes he got from the scanner and plugged them in. 

Simplistic but that is basically what he did. 

· Wes- Yes I think that was the hardest point on our side as well. 

Q5.1 Is there a standard order for populating data into an e-record?

· Maggie- Mapping may have been lot number, bin, etc. the process for us was to take the process 

and make sure we mapped it to correct spot in the EMR. 

· Further discussion concluded that there is not a specific standard sequence or order of data 

elements.

Q5.2 I'm interested in the level of change from a user’s perspective. Was it a big change for them? 

· Wes- Any introduction is a big change. But once they learn how to adopt it, they use it. It is a lot 

different than documenting on paper. If we had introduced it 10 years ago, then it would have 

been very difficult. But once they use it now, they see how much faster it is and they love it. 

6. Similar to what we see as a commitment from the manufacturers, is there a way to toggle on 

and off at practitioner level?

· Wes- We do that, if they scan a barcode that is expired they get a notice from our system that it is 

expired. 

Q6.1 Beyond the technical, you say you are changing the model, but do you offer training, customer support? Did you get 

calls from the customers?

· Wes- Yes, most use our consulting group. We usually train a set of super-users and then they go 

out and train others before implementation. Also, we have a support line and a front line group 

that manages those questions.

· Maggie- They have me on speed dial. For the pilot, we just went through a WebEx presentation;

they picked it up very quickly. Because it didn’t alter their workflow, it just added one step and 

eliminated many others. That was all the training they took.

Q6.2 For EHRs, do your systems have an inventory module? Is the inventory integrated into the process with the 2D 

scanner? 

 [28] 
· Maggie- Yes they can scan directly into inventory from the 2D barcode and the same 

information is used to populate the immunization record as they go along. It deducts from 

inventory what they administer.

· Susan- Not the case with ours. We scan into the IIS and did not maintain any inventory.

· Wes- We are the same way, products get scanned into pharmacy [Cerner inventory application], 

once administered the inventory is adjusted.

Q6.3 This Pilot is all about vaccines, but did users ask about scanning other medicines?

· Maggie- Yes they did. They want to scan everything. So yes, and again in a public health

department, they are programmatically structured so their medications are also structured by 

program. Even the people who weren’t included in the vaccine pilot want to use the barcode. 

· Max Peoples, RxScan – With your solution, were they able to do other meds?

· Maggie- They can do the others as long as there is a barcode on them. 

7. We have heard a couple of discussion points on how to incentivize adoption by practices. 

Anything else we can do to motivate folks who are on the fence?

· Mary Beth- The biggest selling point is really that it is an opportunity to educate providers about 

how many places these data are used and build an understanding that those data are consistent 

and accurate. We just rolled out VTrckS in January of this year. The level of focus on the quality 

of that data has increased exponentially. Everything is all connected in a way that it wasn’t before. 

It is really a perfect time to roll out 2D barcoding because we have a lot of providers 

understanding how important the accuracy of the data is. 

· Wes- I agree with everything you said. 

Q7.1 I want to make sure I understand what you are saying about providers. We want to motivate them to do this, but if 

there is an issue with the data quality, is it their [providers] office expending hours to work through the issue?

· Mary Beth- Yes, I think they are. This is my full time job, this is Jan’s [Washington state program 

manager] full time job. It is such a small part of what providers do. When an error comes 

through it pulls away time from the other million things on their plate, so the added investment is 

important. They now see if they engage on a day-to-day basis they won’t have to take so much 

time on reconciliation error checking, etc. It is very much on the providers’ dime if there is 

inaccurate data that comes up. 

Q7.2 Right, so that is dollars to them?

· Mary Beth- They understand the importance of data quality. 

Q7.3 One thing we need to do is look at 2D barcoding with respect to medications in general. This is really about managing 

medications, vaccines are just a medication. If there is a way that barcoding can make managing meds an easier process, then 

that would be great. We can make this just about vaccines but it's good to keep in mind the bigger context in which these 

practices work. Are vaccines the only target or is it broader?

· John Roberts, GS1- Yes, when the FDA allows barcodes on the rest of pharmaceuticals. We keep 

asking them when they are going to rewrite the 2004 statement so that other meds can be 

managed this way. The California pedigree law only uses 2D DataMatrix barcode. 

 [29] 
· Geoffrey Glaser, BARDA - California has mandated that every pharmaceutical must have a 

global trade identification number and serialization and the FDA stands behind this. Congress 

was to have FDA to take over this program at a national level but it didn’t pass. The Pilot is a 

really good project to help the tail wag the dog on this issue.

· Max Peoples, RxScan- But will it actually be a 2D barcode? There is a stacked barcode as well. 

This meets FDA requirement and is available today, lots aren’t using it though. There has to be 

some incentive for the manufacturers to use this barcode and I think it is California. Do you 

think everyone will switch over?

· John Roberts, GS1- I think they will all switch over. The stacked barcode has to be in alignment. 

The matrix is smaller, easier to print, the Europeans want it, and Asia Pacific wants it. Pfizer is 

using blister packs and I think they will switch very easily. It is so easy to print. 

· Susan Ostroski, Pfizer- We are going to be 2D coding within six months. 

 [30] 
Working Sessions 

Prior to the Education Forum, the registrants were asked to identify three opportunities or challenges 

that the implementation of 2D barcoding presented for the vaccine immunization community. Three 

common themes emerged as the primary areas of interest: 

1. Standards – The majority of challenges focused on the package level product identification and 

reconstituted vaccines. The 2D vaccine barcode currently uses a GS1 standard on the vaccine unit of 

use. The need exists to extend this industry-wide adoption to standardized product identifiers on the 

units of service and units of sale, or the secondary and tertiary packaging. Reconstituted vaccines also 

pose a challenge. Questions exist on how to provide unique product identifiers to each kit of multiple 

components and how to match the individually administered products back to the kit as it was 

recorded in inventory. 

Stakeholders are also concerned about the capability of EMR and IIS solutions to process and 

support 2D barcoding, and are looking ahead to the impact of serialization 2D vaccine barcodes. 

2. Adoption – Adoption was defined as a balance between the value provided by 2D barcodes and the 

cost and benefits resulting from implementation. Primary concerns focused on the availability of 2D 

barcoded vaccine products, the financial considerations of purchasing hardware and software, the 

time commitments needed by clinical and IT staff, practice efficiencies to be gained, and the 

effectiveness in yielding complete and accurate data. 

3. Implementation – Once adopted, many questions exist around how 2D barcoding is implemented 

by manufacturers, providers, IIS, and EMR/IIS solution vendors. Questions were presented 

regarding changes to inventory and administration workflow, office configuration, scanning, and 

training. Similar to the Standards group, reconstituted vaccines are major concern for implementation 

as well. How they are barcoded and the impact on current practice operations is a challenge.

The disproportionate number of submissions for these three areas made them the logical choice to be 

topics for the forum working sessions. Detailed responses received by attendees prior to the forum can 

be found in Appendix D. 

 [31] 

The following section provides notes from each of the working sessions. Many of these notes are 

captured in bullet points or sentence fragments and are included to provide context and background for 

the opportunities and challenges summarized in Appendix D. A full listing of working session groups and 

their associated attendees can be found in Appendix C. 

Group 1 – Standards

The focus of Group 1 was discussion of the benefits and the challenges of adopting and implementing 

GS1 standards for vaccine products. The questions asked of the group and the related discussion points 

are below:

1. We know that 2D barcoding will extend beyond primary packaging to the secondary 

package. The AAP guideline applies only to unit of use. Other than GTIN, what data do you 

plan to include, e.g., lot numbers? What additional data elements are needed?
The group agreed that the GTIN, lot number, and expiration date currently found in the 2D barcode 

on the units of use should also be aggregated at the package level. On the secondary and tertiary (unit 

of service/unit of sale) packaging, add the serial number. 

· An example supporting serial numbers on units of use was presented: To expedite scanning 

of multiple vials from one package, nurses may scan one vial multiple times to account for 

quantity, which can cause a mismatch when scanning during administration if different 

information applied to the vials, e.g., different expiration date or dosage; To overcome, if

each vial has serial number the EMR system can prompt the user to scan each individually.

· Manufacturers feel the track and trace regulation will exist at the package level so there is no 

need to put serial number on the primary unit of use.

· It might be good to have dosage information to help providers to enter inventory.

· Some information is publically available on FDA site, since NDC is part of GTIN, this 

information can be used to access the look up tables. The group agreed this is a good 

solution, although some advised against parsing the GTIN and others cautioned that the 

FDA website is not always current with vaccine data. A discussion ensued on the explanation 

of the evolution of the GTIN and data string components. 

2. Should 2D barcoding expand beyond primary and secondary packaging to the tertiary level? 

Would it be helpful?

Relationships between primary and secondary packaging and what should be printed on those 

packages were discussed, which moved into details about vaccines and vaccine boxes. We broke 

vaccines into three groups and identified how the NDC, lot number, and expiration date should 

be presented on the primary and secondary packaging for each.

· Simple vaccine-1 component, no reconstitution required: 

o NDC will be different on primary and secondary packaging. It was noted that not all 

manufacturers use a different NDC between primary and secondary packaging. The 

FDA guidance is to use different NDCs and the FDA is working with manufacturers 

who do not comply with those regulations. In coming months, all manufacturers will 

be in compliance.

o Lot number and expiration date should be the same on primary and secondary 

packages.

· Combination vaccines - Since there is no need to reconstitute, vaccines will come packaged 

in a vial or syringe and will have its own NDC; like the simple vaccine, the NDC, lot number, 

and expiration will be different on primary and secondary packaging.

· Reconstituted vaccines, which can have one or more active components, require further 

breakdown by the number of active components:

o Reconstituted vaccines with one active component:

a. Both the active component and diluent will have its own NDC

b. The package (a kit containing the active component and the diluent) will have its 

own NDC (different from the one on the active component and the diluent)

c. Lot number will be different for active component and the diluent

d. The lot number on the kit should be the same as the lot number on the active 

component

 [32] 
e. The expiration date will be the earliest expiration date among the components.

o Reconstituted vaccines with one or more active components and one or more 

diluents: 

a. Each component will have its own NDC and the kit will have its own NDC

b. The lot number for kits need to be different from the lot numbers of the active 

components of the kit

c. Expiration date will be the earliest expiration date among the components

The state registries and EMR/IIS vendors disagree and view this approach as unworkable. They 

use both the lot number and expiration date from the active component to receive the kit into 

inventory (they ignore the diluent when scanning to administer vaccines). If the diluent has the 

earlier expiration, the kit would have an expiration date different from the active component and 

will not match when scanning for administration. The registries and EMR/IIS vendors also are 

concerned that HL7 messages will not accommodate using multiple lot numbers for 

reconstituted vaccines. The group discussed the infrastructure needed by EMR vendors to 

address issues resulting in the need to develop an NDC relationship matrix:

· For reconstituted vaccines, three NDCs are needed; one each for the kit, the active 

component, and the diluent. For each NDC, the EMR should be able to relate to the lot 

number and expiration date

· Alternatives were suggested to use an NDC with a package level indicator in a 14-digit 

GTIN. Two models were proposed. 

o The first model uses a GTIN where the NDC will not change and package indicator 

digits will change. The FDA already requires NDC to change when the presentation 

or package level changes, excluding the first model.

o A second model was proposed that uses a GTIN where the NDC changes and the 

packaging level digits remain the same. The group agreed this model will work. This 

model requires an NDC relationship matrix to map NDC to lot number and 

expiration date. 

· Further discussion is needed to determine how the matrix will be consolidated and 

maintained. 

3. The group also discussed the need for standards when using the lot number on the 

secondary packaging. Based on three different vaccine types (simple, combination, 

reconstituted), four different scenarios of using lot number and expiration exist. Should 

there be a universal standard for that?

The group discussed the possibility of needing a lot number matrix. They agreed the matrix will be 

dynamic and carry a high cost of maintenance for all parties. The manufacturers, IIS, EMRs, and 

providers will all have to keep copies of the lot numbers. Currently, only the manufacturers have the 

lot numbers requiring them to publish it periodically and allowing it to be pulled by third party 

services or EMR/IIS vendors.

· The lot number should be the same as the unit of use.

· Currently, no one body owns the lots numbers (as FDA owns the NDCs for an NDC 

matrix), and manufacturers feel a lot number matrix solution is more cost than benefit.

 [33] 
4. How do we ensure uniform capabilities within the EMR vendor community? What are the 

challenges and opportunities for EMR/IIS vendors to standardize 2D capabilities?

The HL7 messaging is intended to ensure that universal capabilities exist within the vendor 

community. However, standards are needed to guide EMR vendors on how to capture and 

process 2D barcodes currently found on vaccine product units of use as well as those 2D 

barcodes that may be found on secondary packaging in the future. 

· Incorporating logic into EMRs to use NDC mapping tables and an NDC matrix introduces 

challenges including EMR cost and time and an IIS burden to cross match to inventory. In 

addition to that, not all EMR solutions have an inventory module.

· The EMR/IIS community needs a set of requirements for EMR capabilities. 

Group 2 – Adoption

The focus of Group 2 was discussion of the benefits and challenges of adopting 2D vaccine barcoding by 

the cross functional groups represented at the Forum. The questions asked of the group and the related 

discussion points are below:

The widespread adoption of scanning 2D vaccine barcodes should be promoted with a structured, 

national, organized approach. We need for leadership to be determined, guidance documents to be 

written, and cohesiveness to exist between the partners. 

1. Financial considerations: What are the financial considerations of 2D barcode scanning? 

Equipment, implementation, and training for registries and providers?

· It would be great if there was a cost benefit assessment tool. Have to show the benefit and 

the value of that benefit. Where is the time saved? How much money is saved?

· Cost of scanners; can CDC buy them for everyone? Can they be purchased in bulk at a 

reduced cost?

o Suggestion of a trial program from scanner manufacturers to increase adoption. If

they get a scanner for a “free trial”, they may ultimately purchase more.

· Could CDC or someone else develop a guidance tool? It would address a broad spectrum of

topics and include recommendations from CDC for providers to use scanners. Ensure the 

tool includes information about the future state of scanning barcodes. Include information 

on who will assume the IIS upgrade costs? Who will assume the EMR upgrade costs? 

· EMR costs to the vendor as well as the private providers should be well documented

· Create a grid that lists the scanners, attributes, costs, compatibility, scanner readiness, etc. 

Eliminate the need for each provider to do the research. Create the same type document to 

assist users in need of an EMR. 

· Remember that scanning adoption is not owned by pediatricians only. Other health care 

providers such as family practice, commercial immunizers, hospitals, and other specialized 

practices should be considered.

2. What adoption incentives exist?

· Pharmaceutical and EMR companies are engaged and looking to be scanner ready. 

· Engage the professional communities and associations

· The development of a cost assessment tool with time saving analysis would be an incentive 

to providers. 

 [34] 
· Perhaps pull in insurance companies, align incentives?

· Standardization is very important. Prepare guidelines that people can use in making 

decisions. Don’t want providers to put money forward only to be out of alignment with 

standards. 

· Adoption psychology in intermediate phase where pilot is wrapping up but this is not a 

market standard yet. What to do to make sure 2D barcoding is not forgotten before the next 

interest is pushed to the forefront? 

o

o

o

o

o

o

Have real user information of how scanning is helpful:

Record keeping (completeness, accuracy, inventory management)

Patient safety

Efficiency is higher

Someone to champion 2D 

Helpful in meeting Meaningful Use criteria and perhaps other tasks.

· CE’s (continuing education) as an incentive. Already an incentive in many states where 

licensure requires CE’s. If so, have an organizing body to create CE’s rather than 62

immunizer registries.

· Showing the public that by adopting the latest technology, health providers and others are 

committed to the latest and best in patient care. This could potentially increase reputation 

and business.

3. What other barriers to adoption exist? 

· Resistance to change; attitude about change. 

· Staff buy-in. This needs to make their life better immediately; otherwise, it will not be used. 

Change taking place from bottom-up might be best; peer-to-peer promotion. Quote: If you 

can hear it from your peers that it is worth doing that goes a long way.” Find champions. 

· Lack of support 

· Costs are a barrier. Offices might cut costs and spend less on EMR or scanners. We need to 

communicate to providers what to look for when purchasing items/services. Quote: “If we 

focus on what we see then we’ll never get beyond where we’re at.” 

· IIS staff playing an increasingly busy role to troubleshoot provider challenges. Adding 

another layer of hardware and of software can be a barrier. There are great variations among 

awardees and their IIS capabilities. 

· First intent is quality care, but there is dollar value attached to it. Quote: “There is really a dollar 

value attached to it, it’s a business.”

4. Benefits to Providers: Is there an immediate efficiency for the providers? Workflow? Other? 

· Workflow impact is important. If it is too much effort, the providers will not use it. Need to 

be considerate of the workflow from vendor perspective to make it easier. Staff talks inside 

and outside the office and buy-in will decrease or be difficult if workflow is not worked out.

· Scanning before or after administration? Only one group member felt strongly about always 

scanning after administration with main concern being on inventory management. 

· The group thought that having a computer at point of care will assist with compliance and 

workflow.

 [35] 
· Understanding the present changes and know how they will fit into the “why” aspect of

changing impacts change. Providing underlying reasons may help acceptance.

· We need to answer “What’s in it for me?” Figure out incentive and communication. 

Grassroots effort, use the carrot versus the stick. 

· Concern with 2-year adoption timeframe. Small pilot involvement thus for, all for that with 

early implementers. Quote: “Where is the support in 2-3 years from now to really manage who is going 

to get this? Free market? I’m worried we’ll be on the next thing 2-3 years from now.”

· Transcription errors for nurses. Maybe position these technologies as stress relievers rather 

than adding stress for people in an already high stress role. More efficient to use this than 

writing numbers down, VIS statements, etc.

· This goes back to incentives. Financial incentive to keep coverage rates high. Could we attach 

an incentive to data quality?

· Need to decide if this is a public health initiative? What are the roles and responsibilities? 

Where is the expectation (if it is there) that an awardee will do something to promote this? 

Does CDC have a strategic plan on this, or are we just dabbling to get facts and information?

· Quote: “Ultimately in the end, everything is for the good of the patient.”

· Completeness and accuracy

· Easier to review records. Assist with inventory and decrements then there should not be a 

problem with matching lots.

· Assist sites in when and how much vaccine to order.

· Assist awardees and sites to move toward a replenishing order model.

5. Benefits to manufacturers

· Accuracy and completeness would help business

· Actions could be seen as a good will gesture

· Global compatibility

6. Increase Immunizer Adoption: How can providers be convinced to invest in and embrace 

barcoding technology?

· Increase customer (patient/practice) satisfaction. Fewer errors when vaccines are scanned. 

Removes notion of visually inspecting records. Practitioners could use this as a marketing 

tool. Quote: “We’re really state of the art and we take your safety very seriously”. Could result in 

patient retention and increased business.

· Quote: “This is about saving time. This is about making your office more efficient. Maintain your customer 

base. Time, efficiency, safety, accuracy, completeness.” Invest $xxx up front with xxx minutes of

training, and the return on your investment is ____. 

· Reconciliation time savings.

· Positive reports. Generate positive information from reports (versus recalls, not being 

involved in bad press)

o VAERS

· Could make practices more technologically advance making them more attractive to some 

practitioners and patients. 

 [36] 
· Quote: “Am I driving? Riding shotgun and navigating? Sitting in the back seat watching the scenery? Or in 

the trunk with the rest of the baggage?”

Group 3 – Implementation

The focus of Group 3 was discussion of the benefits and the challenges of implementing 2D barcoding 

within the various settings (e.g., manufacturing, immunizer provider sites, and IIS) represented by the

breakout session participants. The questions asked of the group and the related discussion points are 

below:

1. What needs to change in inventory and administration workflows in order to incorporate 2D 

barcode scanning? 

· Having the 2D barcode on the exterior packaging would be helpful for the purpose of

recording at inventory. 

· Introducing 2D barcoding into the workflow of immunization provider sites did not appear 

to present difficulties. Where scanners are located (e.g., next to fridge for scanning at 

inventory) may help with efficiency. In general, the 2D barcode scanning process should 

introduce minimal disruption to the current workflow.

· Scanning of 2D barcodes appears to have strong benefits for inventory management. 

· No resolution was reached regarding when vaccine administrations should be recorded 

(before or after vaccination occurs), however, the potential negative impact of untimely 

recording of vaccine administrations by on-site staff was highlighted by the group.

2. What technical support/training was put into place to support implementation? 

· No significant training needs were identified among group members with respect to staff

working at immunization provider sites. As long as the scanner was configured properly, the 

scanning process was easy to integrate. One caution mentioned is that several of the EHRs 

and IISs are only leveraging the lot number and expiration date from the 2D barcode, not 

the NDC/GTIN string, which may bring up additional training issues/needs in the future. 

· Training techniques mentioned by manufacturers included an intensive training ramp up for 

line operators when a new line was introduced. Additionally efforts were taken to inform 

various target audiences (such as wholesalers and health care providers) about 2D barcoding 

through mechanisms such as training operations groups and marketing representatives.

3. What are some potential challenges and opportunities associated with having the 2D 

barcode on both primary and secondary packaging, particularly with respect to reconstituted 

vaccines? 

The discussion about issues arising from differing lot numbers being included on the unit of sale and 

units of use for reconstituted vaccines comprised the majority of this breakout session. This was a 

very rich discussion that cannot be captured completely in a summary; as a result, only key issues are 

documented below. 

· The NDC and lot number represented on the unit of sale and the units of use differ. 

Although the lot number for the unit of sale and unit of use vial containing powder are 

linked by manufacturers, this is not the case within local immunization practices. 

· Immunization practices typically use the lot number to record inventory and vaccine 

administrations. If a practice scans the 2D barcode located on the unit of sale to record 

 [37] 
inventory and later scans the 2D barcode on a unit of use when a vaccine is administered the 

inventory for the practice will not be appropriately adjusted.

· Some potential approaches for addressing this issue were brainstormed by the group, 

however, the group did not feel that any of the three identified were ideal.

o

o

o

Option 1: Scan the unit of sale barcode at administration

Option 2: Create a mapping table. However, ownership and maintenance of this 

table presents challenges. 

Option 3: Introduce modifications to VTrckS. 

4. What are some potential future opportunities for using 2D barcoding?

· Mass vaccinations – The group felt that using 2D barcodes for mass vaccinations may be 

useful. The utility, however, may vary slightly based upon the type of mass vaccination as in 

some situations the product type, expiration date, and lot number would not vary 

significantly. Even in situations where this information did not alter significantly potential 

benefits of scanning 2D barcodes were seen by the group including improving the quality of

records and potentially making it easier for individuals who do not typically work in 

immunization programs to provide assistance to mass vaccination efforts.

 [38] 
Summary and Recommendations

Summary

The Education Forum provided a platform to highlight the benefits offered, challenges remaining, and 

potential solutions to aid the adoption of 2D barcodes on vaccines. There was agreement that holistic 2D 

barcoded vaccine adoption will be eased through collaboration of immunization industry stakeholders. 

The tipping point has not been reached, although good indicators exist that early adoption is occurring. 

As the discussions continued throughout the Forum, several items emerged as themes and 

recommendations. 

Themes

· Involvement from partners, including EMR, IIS, manufacturers, providers, and CDC, is key

· Manufacturer adoption is a driving factor for industry-wide 2D barcode adoption 

· Practitioners and manufacturers are largely ready to adopt 2D barcoding

· Practitioners see clear benefits with inventory and reconciliation

· Examples of effective EMR implementation exist, but EMR functionality varies and so will 

the scanner configuration needed to implement 2D barcoding

Recommendations

 [39] 

Challenges Recommendations Next Steps

Packaging Hierarchy: Relating 

different levels of packaging is difficult 

due to the absence of a relationship 

reference. This challenge extends to the 

handling of reconstituted vaccines. 

Consider product identification sourcing 

to determine how to consolidate NDC 

data from the FDA and lot numbers 

from vaccine manufacturer sources

· Develop a NDC 

relationship matrix. Include 

GTIN and lot numbers. 

· Develop a matrix for NDC 

hierarchy relationships and 

corresponding GTIN

· Conduct additional 

discussion to confirm the 

need to include lot 

numbers. 

· Conduct additional 

discussion to determine 

how best to maintain 

reconstituted vaccine 

component relationships 

Unclear Direction: A recurring 

statement was that there is not a central 

authority from which immunization 

industry stakeholders can obtain 

guidance on 2D barcode vaccine 

adoption.

· Create a roadmap to help 

set expectations and where 

stakeholders should go 

from here.

· Develop and publish 

standardized requirements 

for EMR 2D barcode 

capabilities
 [40] 

Challenges Recommendations Next Steps

· Provide guidance on 

workflow best practices, 

specifically to scan vaccine 

units of use at 

administration

A survey was distributed to all attendees in order to collect feedback on the Forum and what could be 

done to enhance the education and insight gained from the event. Results from the surveys are displayed 

in Appendix E. 
Appendix A – Speaker Presentations

The 2D Barcode History and Progress

Elizabeth Sobczyk, AAP – Manager, Immunization Initiatives AAPAAP Guidance for Practitioners

2D Barcode Technology

Paul Robinson, Deloitte

2D Barcoding Pilot

Dr. Erin Kennedy, CDC, NCIRD/Immunization Services Division, Medical Officer

2D Barcode Pilot: Lessons Learned and Early Findings

Marshall Gaddis, Deloitte

VIS Overview

Ken Gerlach, CDC - NCIRD/Immunization Services Division, Health Scientist

Workflow Analysis

Andrew Sharpin, Deloitte

Breakout Session Overview

Paul Robinson, Deloitte

 [41] 
Appendix B – Attendees 

 [42] 

Attendee Organization Role

Ambrose, Karita Novartis Vaccines & Diagnostics Inc. Sr. Medical Science Liaison

Bahukhandi, Ajay Deloitte Consulting LLP Manager

Baker, Belinda Washington State Department of Health IIS Technology Coordinator

Baker, Gene MedChain Systems, Inc. CEO

Baker, Wes Cerner Corporation RN, BSN

Bennett, Laurie McKing Consulting Corporation Consultant

Bin, Mike Washington State Dept. of Health, Office of 

Immunization

Operations and Response Consultant

Callaghan, Don Iowa Department of Public Health Bureau Chief

Celfo, Christopher GlaxoSmithKline Manager

Charles-Rennie, Trisha McKing Consulting Corporation Meeting Coordinator

Clark-Gagne, Julie Contractor to MI Dept. of Comm. Health Public Health Consultant

Clason, Kristy Motorola Sales Director

Cox, Marietta State of Florida Department of Health Training Consultant

Cullinan, Tara Pediatrics For You CNA

Day, Michael Oregon Immunization Program Operations & Policy Analyst

DiVito, Daniel Sanofi Pasteur Business Planning

Doss, Jillian New Jersey Department of Health CDC Public Health 

Advisor/Assistant Program Manage

Durbin, Joe McKing Consulting Corporation PHA/Vice President

Fierro, Leslie Deloitte Consulting LLP Specialist Master

Flynn, Michael NYS DOH NYSIIS NYSIIS Technical Lead

Friedland, Leonard GlaxoSmithKline Vice President, NA Clinical/Medical 

Affairs

Friedman, David Deloitte Consulting LLP Principal

Gabor, Steve Novartis Vaccines & Diagnostics Inc. Associate Director Public Access

Gaddis, Marshall Deloitte Consulting LLP Analytics Consultant

Gerlach, Ken CDC Health Scientist

Glauser, Geoffrey HHS/ASPR/BARDA Program Manager

Gorman, Chrissie Scientific Technologies Corporation Public Health Advisor

Gowler, Jeremy Novartis Vaccines & Diagnostics Inc. Sr. Director, Marketing
 [43] 

Attendee Organization Role

Greene, Judi Louisiana Immunization Program Program Monitor

Griscom, Margert Mitchell & McCormick Sr. Analyst

Hartstein, Courtney GlaxoSmithKline Vaccine Futures Manager

Haupt, Kim GlaxoSmithKline Senior Director

Hicks-Thomson, Jan WA Dept. of Health Vaccine and IP Registry Integration 

Section Manage

Hoefer, Dina New York State Immunization Information 

System 

Program Manager

Hudson, Donna MSDH/CDC PHA

Jones, Rosemary MSDH VFC Coordinator

Jurrens, Erika GlaxoSmithKline Innovation Manager

Kennedy, Erin CDC Medical Officer

Kirkwood, Bonni Deloitte Consulting LLP Senior Manager

Kline, Thomas GlaxoSmithKline Packaging Area Engineer

Klipic, Ernad DHHS Nebraska-Immunization Dept. IT

Kurilo, Mary Beth Oregon ALERT IIS ALERT IIS Director

Laymon, Barbara Deloitte Consulting LLP Public Health Analyst

Le, Quan LA DHH-OPH Immunization Program Immunization Registry Program 

Manager

Lincicome, Susan Florida DOH IIS Manager

Listigovers, Charles Sanofi Pasteur Senior Director

Little, Tracy ALERT IIS / Oregon Immunization 

Program

Data Exchange Analyst

Lynch, Jennifer CPP Buying Group Marketing Analyst

Metrokotsas, Eric Merck & Co., Inc. Project Manager

Mickle-Hope, Melissa NYC DOHMH MPH

Murchie, Steve Envision Technology Partners, Inc. CEO

Newland, Sophie PATH Program Officer

Ostroski, Susan Pfizer Sr. Director, Management Vaccine

Paster, Jennifer L. Sanofi Pasteur Deputy Director, New Products, 

U.S.

Peoples, Max RxScan,Ltd. President

Rak, Aaron Novartis Vaccines & Diagnostics Inc. Director, Immunization Policy

Roberts, John GS1 US Director healthcare

Robinson, Paul Deloitte Consulting LLP Manager

Salada, Beatrice MCIR MCIR Coordinator
 [44] 

Attendee Organization Role

Sathya, Bhavani New Jersey Department of Health NJIIS Coordinator

Schwartz, Pamela Scientific Technologies Corporation Senior Client Services Manager

Sharpin, Andrew Deloitte Consulting LLP Senior Consultant

Sobczyk, Elizabeth American Academy of Pediatrics Manager, Immunization Initiatives

Spencer, Tanya Buffalo Pediatric Associates Nurse Manager

Springer, Carmen State of Alaska Deputy Immunization Program 

Manager

Stroud, Susan Pediatric Health PA RN

Sturtz, Cynthia Buffalo Pediatric Associates LPN

Tichy, Kim Iowa Department of Public Health IIS Coordinator

Tippet, Andy Zebra Technologies Vertical Management

Tipple, Dayani GlaxoSmithKline Manager, Public Customer Marketing

Wall, Timothy Pediatric Health Associates President

Warf, Thomas HHS/ASPR/BARDA Director, Manufacturing, Facilities, 

and Engineering

Wells, Eron Hewlett-Packard Project Manager

Wheeler, Gary Hewlett-Packard IIS Executive

Wilkinson, John Merck & Co., Inc. Director, Vaccine Network Strategy 

Williams, Warren CDC Health Analyst

Woinarowicz, Mary North Dakota Department of Health Sentinel Site Coordinator

Yett, Gerri State of Alaska Immunization Program Manager
Appendix C –Breakout Groups

 [45] 

Standards Adoption Implementation

Belinda Baker, WA DOH Wes Baker, Cerner Christopher Celfo, GSK

Don Callaghan, Iowa DOPH Dan DiVito, Sanofi Julie Clark-Gagne, MI DOCH

Michael Day, OR Imm Leonard Friedland, GSK Marietta Cox, FL DOH 

Joe Durbin, McKing Kim Haupt, GSK Tara Cullinan, Pediatrics For You

Michael Flynn, NYS DOH NYSIIS Jan Hicks-Thomson, WA DOH Jillian Doss, NEW JERSEY DOH

Chrissie Gorman, STC Dina Hoefer, NY IIS Ken Gerlach, CDC

Margert Griscom, M and M Susan Lincicome, FL DOH Geoffrey Glauser, 

HHS/ASPR/BARDA

Donna Hudson, MSDH/CDC Tracy Little, ALERT IIS/OR 

Imm

Jeremy Gowler, Novartis

Erika Jurrens, GSK Jennifer Lynch, CPP Buying Grp Judi Greene, LA Imm 

Thomas Kline, GSK Sophie Newland, PATH Courtney Hartstein, GSK

Ernad Klipic, DHHS NE Imm Susan Ostroski, Pfizer Rosemary Jones, MSDH

Charles Listigover, Sanofi Pamela Schwartz, STC Mary Beth Kurilo, OR ALERT IIS

Steve Murchie, Envision Tech Tanya Spencer, Buf. Peds Eric Metrokotsas, Merck

Max Peoples, RxScan Timothy Wall, Ped. Health Melissa Mickle-Hope, NYC 

DOHMH

John Roberts, GS1 US Eron Wells, HP Jennifer Paster, Sanofi

Carmen Springer, AK DOH John Wilkinson, Merck Aaron Rak, Novartis 

Gary Wheeler, HP Gerri Yett, AK DOH Bhavani Sathya, NEW JERSEY

DOH 

Warren Williams, CDC Elizabeth Sobczyk, AAP

Susan Stroud, Ocean Health 

Kim Tichy, Iowa DOPH

Dayani Tipple, GSK

Mary Woinarowicz, North Dakota 

DOH

Facilitators and Scribes

Laurie Bennett Barbara Laymon Andrew Sharpin

Ajay Bahukhandi Marshall Gaddis Leslie Fierro
Appendix D – Top Challenges Suggested 

by Forum Registrants

 [46] 

Standards Adoption Implementation 

§ Impact of serialization on 

2D barcodes

§ Package-level GTIN 

considerations

§ Reconstituted vaccine 

barcodes

§ Standard capabilities of 

EMR/IIS solutions

§ Use of both linear and 2D 

barcodes on the same 

product

§ Location of 2D barcodes 

on packages and cartons

§ Financial considerations of equipment, 

implementation, and training for 

registries and providers 

§ Immediate provider efficiencies 

§ Balance between cost, effectiveness, and 

availability of barcoded data

§ Increase adoption among immunizers

§ Increase adoption 

§ EMR/IIS vendors

§ Vaccine Manufacturers 

§ Practitioners 

§ Adoption incentives 

§ Workflow changes 

§ Package-level scanning

§ Combination and 

reconstituted vaccines 

§ Office configuration

§ Training and supporting 

state registry and provider 

scanning operations

§ Future opportunities for 

2D barcoding

§ Mobile applications
Appendix E –Evaluation Feedback 

Results

A survey was distributed to all attendees in order to collect feedback on the forum and understand 

 [47] 
the attendee perspective on what could be done to enhance the education and insight gained from 

the event. The survey document is included below:

 [48] 
Results Summary: Forum Content and Materials 

Thirty-five surveys were collected. Although this accounts for about half of the attendees, their responses 

demonstrate certain commonalities in the responses. The feedback from the surveys received has been 

aggregated.

Quantitative Results

Survey results showed that overwhelmingly, the attendees were satisfied with the content and structure of the 

Forum. The panel discussions and breakout groups provided opportunities for effective discussions. Overall, 

the attendees felt that they gained a better understanding of opportunities and challenges around 2D Vaccine 

Barcoding from the Forum.

 [49] 

Question 1: This forum provided an 

effective opportunity to discuss the 

implications, opportunities, and 

challenges of implementing 2D 

barcoding technology on vaccine 

products.

Agree

29%

Strongly 

Agree

71%

Question 2: The forum materials 

were clear, helpful, and easy to 

follow.

Neutral 

Uncertain

11%

Agree

37%

Strongly 

Agree

52%
 [50] 

Question 3: The Panel Sessions 

allowed for productive discussion.

Neutral 

Uncertain 

11%

Agree

29%

Strongly 

Agree

60%

Question 4: The Panel members 

provided an effective mix of industry 

representatives.

Agree

44% Strongly 

Agree

56%

Question 5: The Breakout Sessions 

allowed for productive discussion.

Agree

34%

Strongly 

Agree

66%
 [51] 

Question 6: The facilitators 

effectively presented workshop 

materials and led group discussions.

Neutral 

Uncertain

6%

Agree

48%

Strongly 

Agree

46%

Question 7: I have a better 

understanding of the industry 

progress relevant to 2D barcoding 

technology.

Disagree

3%

Neutral 

Uncertain

3%

Agree

26%

Strongly 

Agree

68%

Question 8: The forum clarified the 

purpose and benefits of 

implementing 2D barcodes on 

vaccines products and VIS. Neutral 

Uncertain

9%

Agree

31%

Strongly 

Agree

60%
 [52] 

Question 9: I have discussed the 

opportunities and challenges of 

implementing 2D barcode 

technology on vaccine products.

Qualitative Results 

Most of the 35 surveys included additional free form responses capturing the benefits attendees saw from the 

forum as well as opportunities for improvement. The panel discussions, breakout sessions, and access to a 

diverse stakeholder attendance were universally acknowledged as the most useful aspects of the event. In 

terms of attendees’ understanding of key concepts presented at the Forum, there is a fair amount of work to 

be done in the standards area, especially around the usage of NDC and lot numbers in barcodes on secondary 

and primary packaging, and on combination and reconstituted vaccines. There is significant expectation on a 

roadmap of next steps and on CDC guidance on EMR, IIS, and manufacturer implementation requirements. 

Overall, the attendees felt that the Forum provided useful and valuable information, it was well run, and they

gained a better understanding of the cross-functional requirements and challenges experienced in the supply 

chain. 

Questions Responses (Out of 35)

Q10: How did you hear about the 

forum?

· N/A-4

· Pilot website-5

· CDC-2

· Pilot email invitation-7

· Deloitte contact-2

· Pilot newsletter-1

· AIRA email-3

· Colleague/coworker-6

· Pilot participant-5

Q11: Did the registration process pose 

any issues? How could it be improved?

· N/A-6

· No problems or issues-26

· Hotel registration/issues-3

Q12: What part of the forum did you 

find most valuable?

· N/A-7

· Panel discussions-5

· Breakout workgroup discussions-9

· Access to diverse group of stakeholders and resulting 

Neutral 

Uncertain

6%

Agree

43%

Strongly 

Agree

51%
 [53] 

Questions Responses (Out of 35)

conversations, varied perspectives-7

· Practical and/or useful information presented-6

· Q&A opportunities-1

Q13: What part of the forum would you 

change?

· N/A--18

· Next steps/future roadmap-4

· More technical details from manufacturers and EMRs-1

· More specific breakout groups-3

· Longer panel discussions-1

· Improve audio/acoustics/microphones-3

· Exclude weekend start time-3

· More technical information on barcodes-1

· Provide barcode glossary of terms-1

Q14: Are there areas of 2D barcoding 

implementation that you think require 

further investigation?

· N/A--9

· NDC and lot number on primary vs. secondary 

packaging, issues, and crosswalks-8

· Adoption incentives for EMR/IIS-3

· Pilot with more vaccines, participants-1

· Roadmap-2

· Standards guides for EMR, IIS, manufacturers-3

· Combination and reconstituted vaccines-issues, 

implementation, and impact on inventory in IIS-3

· Scanning prior to administering vaccines-1

· Ties to serialization-1

· User education on future vaccines availability-1

· Who should lead the initiative-2

· Collaboration with other initiatives, e.g., MU-1

Q15: What other comments or 

suggestions do you have? Please 

provide any feedback that you think 

may be helpful as we continue to assess 

the use of 2D barcoding on vaccine 

products.

· N/A-20

· Good forum, good opportunity for discussion-7

· Who owns this initiative and should lead-1

· Interagency collaboration, e.g., CDC, WHO, etc-1

· Funding for awardees to offer to providers-1

· AIRA position document on IIS guidelines and best 

practices-1

· NDC/lot numbers a major problem-2

· EMR/IIS functionality will influence provider adoption1

· Improve audio, acoustics -1
Appendix F – Resources 

AAP-Vaccine Barcoding: 

http://www2.aap.org/immunization/pediatricians/barcoding.html

 [54] 

AAP Guidance for Practitioners:

http://www2.aap.org/immunization/pediatricians/BarcodingClinicianGuidance.doc

GS1 Implementation Resources: 

http://www.gs1us.org/industries/healthcare/tools-and-resources/implementation-resources

RTI International Feasibility Study:

http://www.cdc.gov/vaccines/programs/iis/activities/downloads/2d-barcode-trkg-rpt.pdf

Barcodes on Vaccine Information Statements:

http://www.cdc.gov/vaccines/pubs/vis/vis-barcodes.htm