2D Barcode Pilot 

Erin Kennedy, DVM, MPH 

Medical Officer 

National Center for Immunization and Respiratory Diseases 

Immunization Services Division 

Centers for Disease Control and Prevention 

Immunization Services Division 

National Center for Immunization & Respiratory Diseases 

"Reviewed November 2014"
 

 

Outline 

2D Barcode Pilot Background 

• National Childhood Vaccine Injury Act 

• Data Completeness and Accuracy 

• 2D Barcode History – Highlights 

• Feasibility Study on 2D Vaccine Barcode 

• Potential Benefits of 2D Barcodes 

Pilot Implementation 

• Pilot Objectives 

• Pilot Vaccine and Information Flow 

• Pilot Timeline 

• Pilot Composition 

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National Childhood Vaccine Injury Act 

Requires documentation of: 

• Manufacturer 

• Lot number 

• Provider identity 

• Date administered 

• VIS version date and date provided 

•	 Provide copy of the relevant VIS prior to administration 

•	 Report serious adverse events to CDC/FDA’s Vaccine Adverse Event 

Reporting System (VAERS) 

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Data Completeness and Accuracy 

Completeness 

• Approximately 20% of primary VAERS reports are missing lot number 1 

• 55-65% of Immunization Information Systems (IIS) records are missing lot 

numbers 2

Accuracy 

• Study conducted at UCLA’s Children’s Health Center found that 10% of 

immunized children had transcription errors in their electronic immunization 

records 3

• A review of MEDMARX database found that 10% of all vaccination errors were 

transcription or documentation errors 4 

1 CDC, unpublished data, VAERS
 2 2005-2009 Immunization Information Systems Annual Report. Accessed at:
 

http://www.cdc.gov/vaccines/programs/iis/rates/default.htm 

3 Wilton R, et al. Evaluating the accuracy of transcribed computer-stored immunization data. Pediatrics. 1994
 

Dec;94(6 Pt 1):902-6.
 4 Bundy DG, et al. Pediatric vaccination errors: Application of the “5 Rights” framework to a national error reporting 

database. Vaccine. Volume 27, Issue 29, 12 June 2009, Pages 3890–3896 

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Potential Benefits of 2D Barcodes 

• Improve accuracy of immunization information recorded in patient health 

records 

• Improve consistency in availability of immunization information captured in IIS 

and VAERS reports 

• Lot number information can help identify a safety concern with a specific lot 

and identify patients who may have been vaccinated with that lot in the case of 

a recall 

• Reduce administration errors (incorrect, expired, or recalled vaccine) 

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2D Barcode History - Highlights 

• Vaccine Identification Standards Initiative (VISI) - 1997 

• American Academy of Pediatrics (AAP) 2D Barcoding Conference – January 

2009 

• FDA “Guidance for Industry: Bar Code Label Requirements – Questions and 

Answers: Availability” August 11, 2011 

• Amends 2006 guidance 

• Allows manufactures to request a waiver to use alternative coding, (e.g. 

two dimensional symbology) 

• References – vaccines and adverse event reporting requirements 

• AAP and GS1: Issued guidance on use of Data Matrix Barcodes 

o Foundation for appropriate use of GS1 Data Matrix Barcodes on vaccinerelated items 

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Feasibility Study on 2D Vaccine Barcode 

• October 2010 – CDC contracted with RTI International 

• Feasibility Study – impact of a transition to 2D barcodes containing product 

identification, expiration date, and lot number on vaccine vials and syringes 

• Vaccine production 

• Clinical documentation 

• Public health reporting 

• A final report of findings published 

http://www.cdc.gov/vaccines/programs/iis/activities/downloads/2d-barcode-trkgrpt.pdf 

• Recommendation – Pilot Implementation 

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Pilot Objectives 

• Assist in implementation of 2D barcoded vaccines 

• Examine implementation challenges at all stages from vaccine production to 

vaccination encounter to data capture 

• Evaluate use of 2D barcodes 

• User experience 

• Work flow analysis and time and motion studies 

• Document best practices and lessons learned 

• Assess the extent to which using 2D barcoded vaccines and scanners affect 

the completeness and accuracy of vaccine data. 

• Implement 2D barcodes on Vaccine Information Statements (VIS) 

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Immunizer Record system IIS

 

Pilot Vaccine and Information Workflow
 

Scan vaccine data: 

• Entering vaccine 

into inventory 

• Administering 

vaccine 

Receive data from 

the immunizers’ 

record system: 

• Acts as a source 

of evaluation for 

data accuracy 

and 

completeness 

IIS 

Add 2D barcode to 

primary packaging : 

• Data Matrix 

barcode 

containing 

− GTIN 

− Expiration 

date 

− Lot number 

• Distribution to 

pilot participants 

via existing 

vaccine supply 

chain. 

Manufacturer 

Record system 

types: 

• Electronic 

medical records 

(EMR) 

• Immunization 

Information 

Systems (IIS) 

• Track GTIN, 

expiration date, 

and lot number 

Immunizer Record System 

38 
 

 

 

 

 

Pilot Timeline
 

Baseline Data Learning Data Maturity Data

Awardee 

Recruiting 

Immunizer Recruiting Immunizer 

Installation 

Installation 

Scheduling 

Pilot 

WFA 1 WFA 2 

Sep 2011 May 2013 

Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May 

3 Data Capture Periods 

• Baseline: Linear barcoded vaccine administrations 

• Learning: Linear + 2D barcoded vaccine administrations 

• Maturity: Linear + 2D barcoded vaccine administrations 

Additional Data Captured Through 

• User Expectation Survey 

• 2 User Experience Surveys 

• Workflow Analysis 

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Pilot Participation
 

• 2 Vaccine Manufacturers 

• 217 Immunizers 

• 10 Immunization Awardees 

40
 
 

 

 

71 

145 

1 

Immunizer Segments 

Public 

Private 

Commercial 

Pilot Immunizer Demographics
 

66 

9 

4 

88 

50 

Practice Specialties 

Family Practice 

General Practice 

Internal Medicine 

Pediatric 

Other 

Public Private Commercial 

Family Practice 13 53 0 

General Practice 7 2 0 

Internal Medicine 0 4 0 

Pediatric 4 84 0 

Other 47 2 1 

• Over 70% of “Other” are Public Health Depts. 

• The single commercial practice is a commercial pharmacy 

that administers vaccinations 

41 
 

50 

Number of Sites 

45 

40 

35 

30 

25 

20 

15 

10 

5 

0 

45 

27 

24 

19 

17 

13 12 

7 

5 5 5 5 4 3 3 2 2 2 2 1 1 1 1 

16 

AllScripts

eClinical Works

Medent

EPIC

Office Practicum

Insight Netsmart

NextGen

RPMS

Sage Intergy

GE Centricity

e-MD

e-Addabbo

Profiler (Unicare)

SIS

Mitchell & McCormick

Cerner

SuccessEHS

Praxis

Practice Partner

Encounter Pro

Amazing Charts

NetPractice

QS1

No EMR 

EMR Vendors (24 Total) 

 

 

EMR Systems in Use at Pilot Sites
 

Distribution of Pilot Sites by EMR Vendor 

Note: Sites with “No EMR” are IIS Only sites – they report directly to the state registry 

42
 
 

 

 

Questions?
 

For more information please contact Centers for Disease Control and Prevention 

1600 Clifton Road NE, Atlanta, GA 30333 

Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 

E-mail: cdcinfo@cdc.gov Web: www.cdc.gov 

The findings and conclusions in this report are those of the authors and do not necessarily represent the official 

position of the Centers for Disease Control and Prevention. 

National Center for Immunization and Respiratory Diseases 

Immunization Services Division 

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