July 2012 

Impact of a Two-Dimensional 

Barcode for Vaccine Production, 

Clinical Documentation, and 

Public Health Reporting and 

Tracking 

Final Report 

Prepared for 

Immunization Services Division 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

1600 Clifton Road 

Atlanta, GA 30333 

Prepared by 

Alan C. O’Connor 

Saira N. Haque 

Christine M. Layton 

Ross J. Loomis 

Fern M. Braun 

Jacqueline B. Amoozegar 

Amanda A. Honeycutt 

Gilberto Munoz 

Patrick A. Nerz 

Linda A. Chamiec-Case 

RTI International 

3040 Cornwallis Road 

Research Triangle Park, NC 27709 

RTI Project Number 0212793 

November 2014
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contents
 

Section	 Page 

Executive Summary	 ES-1
 

1. Introduction and Background 1-1
 

1.1	 Project Scope and Objectives.....................................................................1-2
 

1.2	 2D Barcoding of Product, Expiration Date, and Lot Data Using GS1 Product
 

Identification Standards ............................................................................1-3
 

1.3	 Relationship of 2D Barcoding to Serialization Initiatives ................................1-4
 

1.4	 Automated Identification of Vaccine Products Initiatives ................................1-5
 

1.4.1	 Vaccine Identification Standards Initiative (VISI) ...............................1-6
 

1.4.2	 Food and Drug Administration’s Barcoding Rule (CFR 69 FR 9120) .......1-6
 

1.4.3	 American Academy of Pediatrics Vaccine Barcoding Initiative...............1-8
 

1.4.4	 Food and Drug Administration’s Updated Question 12 Guidance ...........1-8
 

1.4.5	 Automated Identification of Vaccine Products (AIVP) Advisory Task
 

Group (Canada) .............................................................................1-9
 

1.5	 Initiatives Outside of North America ......................................................... 1-10
 

1.6	 Report Organization................................................................................ 1-10
 

2. Literature Review 2-1
 

2.1 Literature Review Methodology ..................................................................2-1
 

2.2 Barcoding in Health Care...........................................................................2-2
 

2.2.1	 Barcoding and Patient Safety ...........................................................2-2
 

2.2.2	 Barcoding and Vaccine Safety Issues ................................................2-6
 

2.3	 Immunization Practice ..............................................................................2-9
 

2.3.1	 Time–Motion Studies ......................................................................2-9
 

2.3.2	 Vaccine Inventory Management ..................................................... 2-12
 

2.3.3	 Immunization by Provider ............................................................. 2-13
 

2.4 Electronic Data Exchange for Immunization............................................... 2-15
 

2.4.1	 Electronic Health Records .............................................................. 2-15
 

2.4.2	 Immunization Information Systems ................................................ 2-16
 

2.5	 Limitations ............................................................................................ 2-17
 

2.6	 Conclusions ........................................................................................... 2-17
 

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3. Impact on Vaccine Production 3-1 

3.1 Methodology for Assessing Impacts on Vaccine Production ............................3-1
 

3.1.1	 Primary Data Collection...................................................................3-1
 

3.1.2	 Estimation of One-Time Fixed and Ongoing Variable Costs ..................3-3
 

3.1.3	 Estimation of Doses Distributed in the United States, 2013 to 2023......3-4
 

3.1.4	 Assumptions..................................................................................3-5
 

3.2 Qualitative Manufacturer Interview Findings ................................................3-6
 

3.2.1	 Perceptions of Benefits of 2D Barcodes .............................................3-6
 

3.2.2	 Perceptions of AAP 2D Barcoding Initiative and Use of GS1
 

Standards .....................................................................................3-7
 

3.2.3	 Perceptions of Outstanding Questions for the FDA ..............................3-8
 

3.2.4	 One-Time Implementation Costs ......................................................3-8
 

3.2.5	 Effect of Implementation on Production Rates ..................................3-11
 

3.2.6	 Effect of Implementation on Variable Costs .....................................3-11
 

3.2.7	 Small Lot Sizes ............................................................................ 3-12
 

3.3 Benefit-Cost Analysis of Implementation on Vaccine Production ................... 3-12
 

3.3.1	 One-Time Implementation Costs .................................................... 3-12
 

3.3.2	 Ongoing Variable Costs .................................................................3-14
 

3.3.3	 Summary Benefit-Cost Analysis Results ..........................................3-15
 

3.4	 Conclusions ........................................................................................... 3-16
 

4. Knowledge, Attitudes, and Beliefs of Primary Care Providers and Local 

Health Officials 

4.1	 Interview Data Collection with Immunization Provider Associations and
 

Primary Care Physicians ............................................................................4-1
 

4.1.1	 Vaccine End-User Definitions ...........................................................4-1
 

4.1.2	 Traditional Immunization Providers...................................................4-2
 

4.1.3	 Complementary Immunization Providers ...........................................4-3
 

4.1.4	 Public-Sector Immunization Organizations.........................................4-4
 

4.2 Internet Survey of Primary Care Physicians and Local Health Officials .............4-4
 

4.2.1	 Survey Population ..........................................................................4-5
 

4.2.2	 Survey Question Development and Pretesting....................................4-6
 

4.2.3	 Survey Hosting, Availability, and Distribution.....................................4-8
 

4.3 Survey Response .....................................................................................4-8
 

4.4	 Average Number of Staff per Practice ....................................................... 4-12
 

4.5	 Average Number of Vaccines Administered ................................................ 4-12
 

4.6	 IT Infrastructure .................................................................................... 4-16
 

4.7	 Perceptions of Barcode Benefits, Costs, and Needs .....................................4-18
 

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4.8	 Limitations ............................................................................................ 4-25
 

4.9	 Conclusions ........................................................................................... 4-25
 

5. Economic Analysis of the Impact of 2D Barcodes on Clinical
 

Documentation 5-1
 

5.1	 Analysis of Time–Motion Study of Immunization Documentation and
 

Record Keeping........................................................................................5-1
 

5.2	 Economic Model for Quantifying Economic Benefits and Costs ........................5-3
 

5.3	 Benefit-Cost Analysis of Impact on Clinical Documentation for Primary
 

Care Practices and Local Health Departments ..............................................5-8
 

5.3.1	 Expected Adoption Costs per Practice ...............................................5-8
 

5.3.2	 Estimated Economic Benefits per Dose............................................5-10
 

5.3.3	 Forecast of Economic Benefits, Scenario 1: Rate of Adoption Set by
 

Survey Results............................................................................. 5-10
 

5.3.4	 Forecast of Economic Benefits, Scenario 2: Slowing Rate of
 

Adoption by 50% .........................................................................5-17
 

5.3.5	 Forecast of Economic Benefits, Scenario 3: Slowing Rate of
 

Adoption by 67% .........................................................................5-17
 

5.4	 Conclusions ........................................................................................... 5-17
 

6. Impact on Exchange and Management of Immunization Information 6-1
 

6.1	 Methodology for Mapping 2D Barcode Contents Across Data Exchange
 

Standards ...............................................................................................6-1
 

6.1.1	 Selection of Standards for Review ....................................................6-1
 

6.1.2	 Standards Review, Mapping, and Mapping Validation ..........................6-3
 

6.1.3	 Interviews with Stakeholder Representatives .....................................6-4
 

6.2	 Standards Mapping Results........................................................................6-4
 

6.2.1	 One-to-Many Relationship of GTIN to Vaccine Product Fields................6-5
 

6.2.2	 Review of NDC Construction ............................................................6-8
 

6.2.3	 Review of NDC Position in the GTIN ..................................................6-9
 

6.2.4	 Use of NDC, CVX, and MVX in Information Systems.......................... 6-11
 

6.2.5	 Other Considerations ....................................................................6-12
 

6.3	 Limitations ............................................................................................ 6-14
 

6.4	 Conclusions ........................................................................................... 6-14
 

7. Impacts and Implications for Other Stakeholders in the U.S.
 

Immunization Ecosystem 7-1
 

7.1	 CDC 317 Immunization Program Grantees...................................................7-1
 

7.1.1	 Estimated Costs Associated with Integrating 2D Barcodes with IIS .......7-2
 

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7.1.2 Expected Costs Associated with Implementing and Sustaining 

Barcodes in Provider Offices ............................................................7-3
 

7.1.3	 Other Comments Regarding Benefits, Costs, and Feasibility.................7-4
 

7.2 American Academy of Pediatrics (AAP), CDC, and National Organizations ........7-4
 

7.3 Information Systems Vendors ....................................................................7-5
 

7.3.1	 Public Health Agencies ....................................................................7-6
 

7.4 Impacts and Implications for Complementary Immunization Providers ............7-7
 

7.4.1	 Pharmacies....................................................................................7-7
 

7.4.2	 Retail-Based Clinics ......................................................................7-10
 

7.4.3	 Other Complementary Immunizers ................................................. 7-11
 

7.5 Limitations ............................................................................................ 7-11
 

7.6 Summary .............................................................................................. 7-11
 

8. Summary Results and Conclusions	 8-1
 

8.1 Summary Economic Impacts .....................................................................8-2
 

8.1.1	 Distribution of Quantified Economic Benefits and Costs among 

Stakeholders .................................................................................8-3
 

8.1.2	 Measures of Economic Return ..........................................................8-5
 

8.1.3	 Sensitivity Analysis.........................................................................8-5
 

8.2 Recommendations for Implementation........................................................8-6
 

8.2.1	 Mapping Tables of GTIN to NDC to CVX and MVX ...............................8-6
 

8.2.2	 Collaboration and Coordination with Stakeholders ............................ 8-10
 

8.2.3	 Education and Outreach ................................................................ 8-11
 

8.2.4	 Change Management....................................................................8-11
 

8.2.5	 Pilot Implementation ....................................................................8-12
 

References	 R-1
 

Appendixes
 

A Initiatives Outside North America...............................................................A-1
 

B Discussion Guides ....................................................................................B-1
 

C Dosage Estimation Methodology.................................................................C-1
 

D Survey Materials ..................................................................................... D-1
 

E Response Count by VFC Jurisdiction ...........................................................E-1
 

F Time–Motion Study ..................................................................................F-1
 

G Data Mapping ......................................................................................... G-1
 

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Figures
 

Number Page 

1-1. Example Linear and 2D Barcodes.....................................................................1-4
 

2-1. The “5 Rights” to Reduce Medication Errors ......................................................2-3
 

2-2. Common Immunization Administration Process Flow ........................................2-10
 

4-1. Take 10 to Enhance Vaccine Barcodes Survey Announcement .............................4-5
 

4-2. Primary Care Provider Survey Response, by 4-Digit Zip Code............................ 4-11
 

4-3. Health Department Survey Response, by 4-Digit Zip Code................................ 4-11
 

4-4. Survey Question for Primary Care Practices’ and Health Departments’
 

Likelihood to Use 2D Barcodes ......................................................................4-19
 

6-1. Immunization Processes, Systems, and Standards.............................................6-6
 

6-2. National Drug Code (NDC) Embedded in Global Trade Item Number (GTIN)........6-10
 

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Tables
 

Number Page 

1-1. Timeline of Important Vaccine Barcoding Legislation and Guidance......................1-7
 

1-2. Countries with Known Automated Prescription Pharmaceutical Product
 

Identification Initiatives Outside of the North America, as of August 2011 ..........1-10
 

2-1. Summary Literature Review Findings ...............................................................2-1
 

2-2. Insights from Literature Regarding Barriers and Facilitators to Change That 

May Affect Adoption and Use of 2D Barcodes ....................................................2-6
 

2-3. Vaccine and Other Biologic Product Recalls, 2005–2010 .....................................2-8
 

2-4. Vaccine Recalls Reported by CBER in 2010 .......................................................2-8
 

2-5. Comparison of Data Collection Tasks in Paper-Based vs. Electronic Systems .......2-11
 

3-1. Manufacturers that Produce, Market, and/or Distribute Licensed Vaccine 

Products in the United States ..........................................................................3-2
 

3-2. Interviewed Manufacturer Representatives .......................................................3-3
 

3-3. Parameter Estimates for Economic Model of Vaccine Production ........................ 3-13
 

3-4. U.S. Vaccine Market Forecast, Excluding Travelers’ and Defense Products
 

(Doses) ......................................................................................................3-15
 

3-5. Time Series of Costs and Benefits for Vaccine Manufacturers ............................ 3-16
 

4-1. Summary of Anticipated Barriers and Facilitators to Adopting 2D Barcoded 

Vaccines by Provider Group ............................................................................4-2
 

4-2. Survey Question Topics..................................................................................4-6
 

4-3. Survey Distribution Mechanisms......................................................................4-9
 

4-4. Estimated Survey Coverage for Primary Care Practices and Health
 

Departments............................................................................................... 4-10
 

4-5. Mean Number of Staff in Physician, Nursing, and Assistant Positions in
 

Primary Care Practices that Prepare and Administer Vaccines, by Specialty 

and Practice Size......................................................................................... 4-13
 

4-6. Average Number of Staff in Physician, Nursing, and Assistant Positions that 

Prepare and Administer Vaccines in Local Health Departments .......................... 4-14
 

4-7. Average Number of Doses Administered per Year by Primary Care Practices,
 

by Specialty and Practice Size.......................................................................4-15
 

4-8. Average Number of Doses Administered per Year by Health Departments........... 4-15
 

4-9. Average Number of Locations within Primary Care Practice and Health
 

Departments Where Vaccines Are Prepared for Administration, by Specialty 

and Practice Size......................................................................................... 4-16
 

4-10. Percentage of Primary Care Practices and Health Departments Currently
 

Using Computerized Systems, by Specialty and Practice Size ............................ 4-17
 

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4-11. Percentage of Primary Care Practices and Health Departments without EHR 

Systems Currently, but Expecting to Adopt Them in the Future, by Specialty 

and Practice Size, 2011–2015 .......................................................................4-20
 

4-12. Percentage of Primary Care Practices and Health Departments with Systems
 

or Procedures in Place to Monitor the Number of Doses in Stock, by Specialty 

and Size.....................................................................................................4-21
 

4-13. Likelihood of Primary Care Practices and Health Departments to Use 2D
 

Barcode .....................................................................................................4-22
 

4-14. Number and Percentage of Primary Care Practices Reporting They Are More
 

Likely to Report Immunizations to IIS due to 2D-Barcoded Vaccines .................. 4-23
 

4-15. Providers’ Perceptions of Types of Technical Assistance Needed to Implement
 

2D Barcode Scanning................................................................................... 4-24
 

4-16. Stated Importance and Ranking of Factors in Primary Care Providers’ Decision
 

to Use 2D Barcodes ..................................................................................... 4-26
 

4-17. Stated Importance and Ranking of Factors in Health Departments’ Decision to
 

Use 2D Barcodes ......................................................................................... 4-27
 

5-1. Average Time for Immunization Activities.........................................................5-2
 

5-2. Estimated Change in Documentation Time per Dose, with and without an EHR
 

System ........................................................................................................5-3
 

5-3. Wage Rates and Other Estimated Parameters ...................................................5-6
 

5-4. Estimated Costs for Workflow Redesign, Training, and Scanner Purchases and
 

Maintenance, per Practice and Health Department, by Specialty and Size .............5-9
 

5-5. Estimated Documentation Benefit per Dose, by Practice and Health
 

Departments, by Specialty and Size............................................................... 5-11
 

5-6. Scenario 1: Forecast of Barcode Adoption, by Specialty and Size (Number of
 

Practices and Health Departments) ................................................................ 5-12
 

5-7. Scenario 1: Forecast of Documentation Benefits by Practice and Health
 

Department ($ thousands) ........................................................................... 5-14
 

5-8. Scenario 1: Forecast of Adoption and Usage Costs, by Practice and Health
 

Department ($ thousands) ........................................................................... 5-15
 

5-9. Scenario 1: Forecast of Net Benefits by Practice and Health Department ($
 

thousands) .................................................................................................5-16
 

5-10. Scenario 2: Forecast of Barcode Adoption, by Specialty and Size (Number of
 

Practices and Health Departments) ................................................................ 5-18
 

5-11. Scenario 2: Forecast of Net Benefits by Practice and Health Department ($
 

thousands) .................................................................................................5-19
 

5-12. Scenario 3: Forecast of Barcode Adoption, by Specialty and Size (Number of
 

Practices and Health Departments) ................................................................ 5-20
 

5-13. Scenario 3: Forecast of Net Benefits by specialty and size and Health
 

Department ($ thousands) ...........................................................................5-21
 

5-14. Comparison of Net Benefit Forecasts Accruing to Primary Care Practices and
 

Health Departments for Three Adoption Scenarios ........................................... 5-22
 

6-1. Standards Reviewed and Their Application........................................................6-2
 

6-2. Summary Mapping Tablea, b ............................................................................6-8
 

6-3. Fluzone NDC Embedded in GTIN....................................................................6-11
 

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6-4. NDC Structure for Vaccine Products by Licensee in the FDA Database ................ 6-12
 

7-1. Known AAP and CDC Costs for the Barcoding Initiative.......................................7-5
 

7-2. Characteristics of Complementary Provider Groups ............................................7-8
 

7-3. Considerations for Complementary Immunizers............................................... 7-10
 

8-1. Comparison of Forecast of Quantified Net Benefits for Vaccine Manufacturers, 

Primary Care Providers, Health Departments, and Public-Sector Organizations......8-2
 

8-2. Scenario 1: Forecast of Economic Benefits and Costs by Stakeholder, Rate of
 

Adoption Set by Survey Results ($ Million) .......................................................8-3
 

8-3. Scenario 2: Forecast of Economic Benefits and Costs by Stakeholder, Rate of
 

Adoption Slowed by 50% ($ Million) ................................................................8-4
 

8-4. Scenario 3: Forecast of Economic Benefits and Costs by Stakeholder, Rate of
 

Adoption Slowed by 67% ($ Million) ................................................................8-4
 

8-5. Summary Measures of Economic Return, based on Forecast of Quantified Net
 

Benefits for Vaccine Manufacturers, Primary Care Providers, Health 

Departments, and Public-Sector Organizations ..................................................8-5
 

8-6. Sensitivity Analyses Using Upper- and Lower-Bound Time–Motion Savings
 

Results.........................................................................................................8-7
 

8-7. Sensitivity Analyses Using Upper- and Lower-Bound Time–Motion Savings
 

Results and Including Pediatric, Family Medicine, and Health Department 

Practices Only ...............................................................................................8-8
 

8-8. Summary of Recommendations.......................................................................8-9
 

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EXECUTIVE SUMMARY
 

According to the National Childhood Vaccine Injury Act (NCVIA) (1986), documentation for 

immunization must include manufacturer and lot number and the American Academy of 

Pediatrics (AAP) recommends recording the expiration date (AAP Committee on Infectious 

Diseases, 2012). Since 2004, the U.S. Food and Drug Administration (FDA) has required 

that vaccine product labels be printed with a linear barcode containing a product’s National 

Drug Code (NDC), which identifies the manufacturer, product name, and packaging 

information (FDA, 2004). Linear barcodes that could contain these data would be too large 

to appear on a label affixed to a 0.5 mL single-dose vial. Thus, barcodes appearing on vials, 

ampoules, and syringes of vaccines do not contain the lot number or expiration date. 

The intent of the FDA’s linear barcode rule was to enhance patient safety using machinereadable codes (FDA, 2004), but AAP (2010) noted that these barcodes are ineffective for 

patient safety because they omit lot number and expiration date. AAP has since assembled 

vaccine manufacturers, providers, public health groups (including the Centers for Disease 

Control and Prevention [CDC]), and other immunization stakeholders in an initiative to 

transition barcodes on unit-of-use vaccine containers from linear to two dimensional (2D). 

2D barcodes are capable of containing product, expiration date, and lot number on product 

labels (Figure ES-1). AAP cited changes since FDA’s 2004 rule was enacted, including 

decreasing costs of using 2D barcodes, changing immunization schedules, new vaccine 

products, and the prospect of meeting FDA’s safety goals in its initiative. The FDA (2011) 

agreed with AAP’s assessment and issued industry guidance in 2011 that stated it would 

grant vaccine manufacturers waivers to replace linear barcodes with 2D ones. A waiver is 

not necessary if both linear and 2D barcodes appear on a label. 

Figure ES-1. Example Linear and 2D Barcodes 

Example of linear barcode Example of 2D barcode 

Current linear barcodes required by the FDA 

contain only the vaccine product identification 

information. 

A 2D, or data matrix, barcode can include product 

identification information as well as expiration 

date and lot number. 

ES.1 Project Scope, Objectives, and Methodology Overview 

In October 2010, CDC’s Immunization Services Division contracted with RTI International, 

an independent, nonprofit research institute, to study the impacts 2D barcodes may have on 

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Executive Summary 

vaccine production, clinical documentation, and public health reporting and tracking for 

stakeholders in the U.S. immunization system. The study included a prospective economic 

analysis and an information systems analysis.1 Stakeholders included in the study were 

vaccine manufacturers, vaccine users (e.g., immunization providers, immunization program 

managers), and immunization data users (e.g., immunization information systems [IIS], 

data exchange groups, vaccine-related tracking systems). 

The United States has more than 30,000 pediatric, family health, internal medicine, and 

obstetric-gynecology (ob-gyn) practices (American Medical Association [AMA], 2011); nearly 

4,000 health departments (National Association of County and City Health Officials 

[NACCHO], 2010); and thousands of pharmacies, retail-based clinics (RBCs), and mobile 

immunization sites. Because of this breadth, the scope for all quantitative analyses was 

narrowed to primary care providers (pediatric, family medicine, internal medicine, ob-gyn 

practices) and health departments. Impacts for other immunizers were reviewed 

qualitatively. 

This study had three overarching objectives, which were organized into tasks: 

1.	 Stakeholder engagement to document knowledge, attitudes, and beliefs 

about the impacts and implications of 2D barcodes for automated identification of 

vaccine products. Methods included semistructured interviews with representatives of 

all stakeholder groups and an internet survey of immunization providers. 

2.	 Prospective economic impact analyses to assess public economic benefits and 

costs and the distribution of these costs and benefits across stakeholders. Primary 

and secondary data were inputted into economic models to analyze costs and 

benefits over a 10-year period of barcode use by immunizers, analyzing three 

different rates of barcode usage uptake for providers. The models developed 

analyzed the period from 2011 through 2023, which is 10 years beyond a predicted 

2D barcode availability date of late 2012 or early 2013. 

3.	 Data exchange analysis and information technology standards mapping to 

assess technical feasibility and identify any gaps in the technology infrastructure 

supporting standards-based exchange of immunization data. We reviewed health 

information exchange and data standards relevant to 2D barcodes to assess how 

information can be transmitted across stakeholders. This issue is particularly 

important as the United States moves from a largely paper-based records system to 

an electronic one. 

ES.2 Two-Dimensional Barcoding of Product, Expiration Date, and 

Lot Number on Unit-of-Use Vaccine Product Labels 

2D barcodes have the potential to improve the accuracy and efficiency of documentation for 

immunization. Information that is currently handwritten, typed into a computer, or both 

could be automatically captured by an inexpensive imaging device or scanner (currently 

1 Contract number GS10F0097L, awarded October 1, 2010, with a period of performance to 

September 30, 2011, and extended through March 31, 2012. 

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Executive Summary 

about $300). This information could automatically populate an electronic health record 

(EHR), practice management system, or IIS or be printed and placed in a paper file. 

AAP, Canada’s Automated Identification of Vaccine Products initiative, and other countries’ 

groups are recommending the use of internationally-standard product identifiers, 

particularly the Global Trade Item Number (GTIN) (Public Health Agency of Canada and GS1 

Canada, 2010). GS1, a global product identification standards organization, created the 

GTIN to identify products in the supply change. For prescription pharmaceutical products in 

the United States, the GTIN is a 14-digit numerical identifier with the NDC embedded in it 

(Figure ES-2). AAP has collaborated with GS1 to develop guidance for vaccine 

manufacturers on using GS1 standards for vaccine products. A principal advantage of using 

GTINs is that they must be registered with GS1 to ensure that a GTIN only refers to one 

specific product. 

Figure ES-2. National Drug Code (NDC) Embedded in Global Trade Item Number 

(GTIN) 

GS1 Company Prefix + Item Reference 

Although the length of the GS1 Company Prefix and 

the length of the Item Reference vary, they will 

always be a combined total of 12 digits. 

Check Digit 

0 0 3 1 2 3 4 5 6 7 8 9 0 6 

Position Position 2 Position 13 Position 

GS1 Indicator Digit 

Source: GS1 Healthcare US 

ES.3 Public Health Opportunity 

2D barcoding of vaccines has the potential to prevent medication errors and ensure that the 

information about the vaccine received is entered accurately into the patient record 

(Simpson, 2001). Collecting product, expiration date, and lot information is critically 

important because of the possibility, however remote, that there may be specific vaccine 

safety concerns following administration. Public health agencies and providers must be able 

to locate persons that may have been administered a recalled product. Knowing the lot 

number can also identify safety concerns with a specific lot. 

A review of the literature revealed that using 2D barcodes and scanners to document 

immunizations could improve patient safety and immunization surveillance: 

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Executive Summary 

 Wilton and Pennisi (1994) found that at least 10% of 2,098 children immunized at 

UCLA’s Children’s Health Center had transcription errors in their electronic 

immunization records. 

 Bundy et al. (2009) found errors in recording product data (i.e., DTaP, Tdap, DT, or 

Td), errors in prescription (11%), errors in transcribing and documenting (10%), and 

dispensing errors (4.1%) in 607 patients’ immunization records. 

 More than 25% of records in the Vaccine Adverse Event Reporting System (VAERS) 

are missing lot number data (Kennedy, 2012). 

 Between 2005 and 2010, 14 recalls out of 138 (10.1%) for biologics were for
 

vaccines.
 

 As long as they enroll by 2012, eligible Medicare providers may earn up to $44,000 

over 5 years; eligible Medicaid providers may earn up to $63,750 over 6 years. The 

Centers for Medicare & Medicaid Services’ (CMS’s) incentives are anticipated to have 

a dramatic impact on health care providers’ adoption of EHRs and, by association, 

the potential adoption of barcoding for data collection. 

ES.4 Impact on Vaccine Production 

Of the 11 manufacturers that have FDA-approved vaccine products on the U.S. market, 

seven participated in our study. These seven manufacturers produce, market, or distribute 

over 90% of the total number of vaccine products licensed for sale in the United States. Five 

have plans to adopt 2D barcoding on the unit of use, one has no current plans to do so, and 

one is currently undecided. 

Based on manufacturers’ feasibility assessments, the technology is available to enable rapid 

2D barcode printing, imaging, and image verification, and manufacturers will be able to 

optimize the printing process. Neither of the two manufacturers indicating they would not be 

implementing 2D barcoding objected to 2D barcoding because of technically infeasibility, 

suggesting that this is an engineering exercise and one-time expense rather than a crosscutting change in production. 

The 2D barcode will contain static NDC data and the variable expiration date and lot 

number, essentially precluding the option of having the symbol printed off site by a vendor. 

Having the 2D barcode printed off site, as is commonplace with linear barcodes today, 

would present significant coordination and inventory management challenges, as well as 

operational and regulatory risks. Therefore, manufacturers will have vendors produce the 

label but will print the 2D barcode at their production facilities. 

The time required to implement barcoding was estimated to be at least 12 months but no 

more than 24 months and depended on such factors as number of packaging and labeling 

lines, capital budgeting and procurement procedures, and scheduled production downtime. 

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Executive Summary 

Post implementation, most manufacturers expect negligible incremental printing or other 

costs that would be above current expense levels. 

We estimate one-time costs of $30.60 million for the 5 manufacturers indicating they intend 

to implement 2D barcoding, accruing between 2011 and 2013. The only incremental costs 

or benefits estimated pertain to eliminating peel-off labels from syringes and vials. These 

incremental benefits are expected to total $54.08 million (2010$) over this period, 

offsetting one-time costs to yield net benefits of $23.48 million through the end of the 

period of analysis of 2023. 

The net present value (NPV) of expected manufacturer costs and benefits is $5.02 million 

when the Office of Management and Budget (OMB) specified 7% real social discount rate is 

applied (OMB, 1992).2 At a rate set to 10%, which is closer to the biopharmaceutical 

industry real working average cost of capital (Harrington & Miller, 2010), the NPV is $0.17 

million. A rate of 10.12% sets the NPV to zero, confirming our interview findings that 

manufacturers view the 2D barcoding initiative as a one-time cost. 

ES.5 Impact on Clinical Documentation 

Our approach to quantifying economic benefits was to analyze how scanning 2D barcodes 

could reduce the amount of time spent documenting immunizations relative to a businessas-usual case in which product, expiration date, and lot number are recorded by hand when 

reading product labels. The economic model combined survey data on expected barcode 

usage with time savings per dose associated with more efficient documentation. 

ES.5.1 Survey Data Collection and Results 

To ascertain the impacts on clinical documentation, RTI conducted telephone interviews with 

major professional associations and organizations, including AAP, American Academy of 

Family Physicians, American Congress of Obstetricians and Gynecologists, American College 

of Physicians, American Medical Association, American Pharmacy Association, American 

Hospital Association, Convenient Care Association, CDC, Association of Immunization 

Managers, American Immunization Registry Association, NACCHO, Visiting Nurses 

Association of America, Maxim Healthcare, and Walgreen’s. 

2 Net present value is the sum of benefits and costs after discounting cash flows to a single year in 

order to determine whether an investment is acceptable, given some minimum rate of return (i.e., 

the discount rate). 

ES-5 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Executive Summary 

We also fielded an internet survey to primary care providers and local health departments 

(LHDs) in late spring 2011.3 The total number of completed surveys was 4,568, but after 

data cleaning and application of inclusion criteria, 3,669 were included in our analysis. Of 

these, 2,816 were private-practice providers and 853 were LHDs. If respondents did not 

provide their specialty or number of physicians, their responses were excluded from the 

analysis. We also applied an algorithm that reviewed respondents’ contact information, zip 

codes, number of staff, and immunization volume to exclude duplicate records and outlier 

responses to the number of doses per physician. 

Survey responses varied greatly by specialty; the greatest rate of response came from 

pediatrics and the lowest came from internal medicine. Out of an estimated population of 

4,937 pediatric practices in the United States (AMA, 2011), 1,442 responses were received, 

equating to an estimated coverage rate of 29.2%. We received 968 responses from family 

practices (10.1% of 9,561 practices) and 853 from LHDs (24% of 3,669). Only 101 

responses were from ob-gyn practices (1.8% of 5,725) and 57 from internal medicine 

practices (0.5% of 12,462). 

Table ES-1 presents the anticipated likelihood of 2D barcode adoption by provider: 

 43.0% of pediatric practices would likely use 2D barcodes, and an additional 19.5% 

would if they had an EHR system. Only 4.0% said they would not use them, and only 

16.5% said they did not know if they would use them. 

 53.5% of family medicine practices would likely use 2D barcodes, 16.3% would use 

them if they had an EHR system, 7.0% would not use them, and 23.2% said they did 

not know if they would use them. 

 Less than half of ob-gyn (48.9%) and internal medicine (34.5%) practices said they 

would use 2D barcodes. About 20% of ob-gyn practices and 36.4% of internal 

medicine practices said they did not know whether they would use them. These 

results must be interpreted cautiously because of the low number of responses for 

these two specialties. 

 39.2% of LHDs would likely use 2D barcodes, 26.3% would if they had an EHR 

system, 3.6% would not use them, and 30.9% said they did not know if they would 

use them. 

3 The project’s available resources precluded conducting a representative sample survey. Instead, we 

developed a marketing strategy “Take 10 to Enhance Vaccine Barcodes” and partnered with AAP, 

American Academy of Family Physicians (AAFP), American College of Obstetrician Gynecologists 

(ACOG), AMA, Association of Immunization Managers (AIM), and Vaccines for Children [VFC] 

Program coordinators to promote the survey. Partnering organizations received electronic files that 

included PDF and MS Word documents containing descriptions about and links to the World Wide 

Web-based survey. To encourage participation in the survey, respondents were entered into a raffle 

to receive one of 10 iPads. Participating VFC jurisdictions will receive survey results compiled for 

their jurisdiction. 

ES-6 
 

Pediatrics (n=1,442) 60.0% 19.5% 4.0% 16.5% 

Family practice (n=968) 53.5% 16.3% 7.0% 23.2% 

Ob-gyn (n=101) 48.9% 18.1% 12.8% 20.2% 

Internal medicine (n=57) 34.5% 23.6% 5.5% 36.4% 

LHDs (n=853) 39.2% 26.3% 3.6% 30.9% 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Executive Summary 

Table ES-1. Likelihood that Practices and LHDsa Would Use 2D Barcodes 

My Practice Would
 

Likely Use the 

Barcode If We 

Had an Electronic 

Medical Record 

System 

Yes, My Practice 

Would Likely Use 

the Barcode 

No, My Practice 

Would Not Likely 

Use the Barcode 

I Do Not Know If 

My Practice Would 

Specialty Use the Barcode 

a

LHD (Local health department) 

 Overall, 113 primary care respondents (7.0% of 1,619 providing sufficient 

information) indicated that they did not report immunizations to IIS currently but 

would be more likely to do so if the 2D barcode were available. 

Deciding whether to implement a new technology includes considering a variety of different 

factors. We asked respondents to review various factors and their relative importance in 

deciding whether to implement 2D barcode scanning. Primary care providers, in general, 

ranked the following decision factors as the five most important (Table ES-2):4 

1.	 increased accuracy of records 

2.	 decreased time spent recording vaccine information and/or documenting 

immunization 

3.	 reliability of the barcodes 

4.	 usability of the barcode scanners 

5.	 more efficient and accurate management of inventory 

ES.5.2 Economic Model Results 

An analysis of a time–motion study conducted by the Verden Group in 33 practices in 2009 

suggests that practices with EHRs will save approximately 39.4 seconds per dose scanned 

(95% CI: 34.8–43.9) and practices without EHRs will save about 36.5 seconds per dose 

(32.3–40.5).5 

4

Responses were ranked, with unimportant equal to 0, somewhat unimportant equal to 1, neutral 

equal to 2, important equal to 3, and very important equal to 4. 

5

The resulting dataset includes activity-specific time–motion estimates for the administration of 724 

vaccines to 302 patients (cases) at 33 practices (30 pediatric practices, 3 family practices) in 17 

states. 

ES-7 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Executive Summary 

Table ES-2. Primary Care Providers’ Perceptions of the Importance of 2D Barcode 

Usage Decision Factors (0 = unimportant, 4 = very important) 

Mean 

Rank Factor Score 

1 Increased accuracy of records 3.657 

2 Decreased time spent recording vaccine information and/or documenting 3.631 

immunization 

3 Reliability of the barcodes 3.567 

4 Usability of the barcode scanners 3.553 

5 More efficient and accurate management of inventory 3.528 

6 Readability of the barcodes 3.522 

7 Cost of scanner(s) 3.198 

8 Potential decrease in the number of vaccines that do not get billed to a private 3.182 

payer 

9 Training 3.068 

10 Possible changes to workflow 2.972 

Based on practices responding to our survey’s workflow, volume of immunizations 

performed, and size and specialty characteristics, we forecasted expected adoption costs 

and cost savings from reducing the amount of time spent documenting immunizations for all 

primary care providers and health departments in the United States. 

The model estimated that, if primary care practices and LHDs follow their stated preferences 

to use the 2D barcode, net benefits would be $333.6 million over the period from 2013 

through 2023 for these stakeholders alone. If the rate of adoption were slowed by 50%, net 

benefits would decline to $326.8 million. If the rate of adoption were slowed by 67%, net 

benefits would decline to $311.3 million. 

ES.6 Impact on Public Health Reporting and Tracking 

A 2D barcode has yet to be used for vaccine product identification in the United States; 

therefore, it was of paramount importance to understand how different data exchange 

standards would accommodate its use. 

We analyzed data exchange standards involved in immunization messaging: GS1, Health 

Level 7 (HL7), CDC 2.5.1 Implementation Guide for Immunization Messaging under HL7, 

X12, Healthcare Information Technology Standards Panel (HITSP), and National Council for 

Prescription Drug Program (NCPDP). We assessed how data elements to be contained in the 

2D barcodes would interoperate with these standards. We also interviewed stakeholders 

from IIS, EHR vendors, HL7, and CDC and compiled additional resources provided by those 

stakeholders. 

ES-8 
 

 

 

 

 

 

 

 

Table ES-3 provides a summary of how different 2D barcode elements are transmitted 

across immunization messaging standards. Because the NDC has three segments (labeler, 

product, and package codes), and some standards require vaccine product data to be in 

these discrete segments, the unsegmented GTIN does not map directly to individual fields. 

In other words, there is a one-to-many relationship between the GTIN and most data 

exchange standards’ vaccine product fields. In contrast to the GTIN, the expiration date and 

lot number map directly to individual fields across standards and, therefore, do not present 

similar challenges. 

Table ES-3. Summary Mapping Tablea, b 

GS1 

FDA’s National 

Drug Code 

HL7— 

Barcoding 

Message 

Segment 

2.5.1 

Implementation 

Guide 

X12—837P 

Transaction 

HITSP 

Immunization 

Messages NCPDP 

Global 

Trade Item 

Number 

(GTIN) 

Label code 

Product segment 

Package segment 

Administered 

code 

Substance 

manufacturer 

name 

Administered 

barcode 

identifier 

Substance 

manufacturer 

name 

Administered 

code 

Administered 

drug strength 

volume 

Administered 

drug strength 

volume units 

Labeler code

Product 

segment 

Package 

segment 

Substance 

manufacturer 

Administered 

code 

Labeler 

code 

Product 

segment 

Package 

segment 

Expiration 

date 

(YYMMDD) 

Substance 

expiration date 

Substance 

expiration date 

Batch or lot 

number 

Substance lot 

number 

Substance lot 

number 

Substance lot 

number 

 

 

 

 

 

 

 

 

 

 

Executive Summary 

a

The yellow cells denote how the GTIN is mapped, green denotes the expiration date, and orange 

denotes the lot number. Please note that there are two columns for HL7. 

b

The NDC within the GTIN is the information source for the other standards. 

A mapping table of GTIN, NDC segments, CDC’s product identifier (CVX) and the 

manufacturer identifier (MVX), and related codes will be necessary. The table helps facilitate 

information exchange by outlining where the information in the barcode would fall in each 

standard, providing those who will implement the barcode the specifications necessary to 

accommodate receiving and interpreting the GTIN. 

An undercurrent to reviewing the implications of the 2D barcode for standards-based data 

exchange is legacy issues associated with the NDC, CVX, and MVX. Traditionally, the NDC 

has not been used in immunization documentation, reporting, and tracking. Although some 

systems are able to accommodate the NDC, most use the CVX and MVX. IIS, for example, 

require the CVX, MVX, and lot number to document an immunization (CDC, 2011e). In the 

ES-9 
 

 

 

 

 

 

 

 

 

 

 

Total benefits (million $) 501.87 481.36 460.82 

Total costs (million $) 153.33 139.66 134.53 

Total net benefits (million $) 348.53 341.71 326.29 

Net present value (3% discount rate) (million $) 271.49 263.37 249.41 

Net present value (7% discount rate) (million $) 196.81 188.10 175.97 

Benefit-cost ratio (3% discount rate) 3.0 3.1 3.1 

Benefit-cost ratio (7% discount rate) 2.7 2.8 2.7 

Internal rate of return 49% 46% 43% 

 

 

 

 

 

 

 

 

Executive Summary 

future, the NDC will be the cornerstone of inventory control systems; thus, it is important 

that techniques be developed to use the NDC code. 

ES.7 Summary Economic Analysis Results 

Our economic analysis forecasts net economic benefits of at least $326.3 million to $348.5 

million from 2011 through 2023 (Table ES-4). We calculated a series of performance 

measures on the time series of benefits and costs. These measures lead us to conclude that 

transitioning to 2D barcoding for vaccine product labels will have a benefit-to-cost ratio of 

2.7 to 2.8 (using the OMB-specified 7% social discount rate); in other words, for every $1 

expended, $2.70 to $2.80 in benefits are expected to accrue over the period from 2011 

through 2023. 

Table ES-4.	 Summary Public Measures of Economic Return (All Primary Care 

Specialties) 

Costs for vaccine manufacturers, primary care providers (pediatrics, family medicine, ob-gyn, and 

internal medicine), health departments, and public-sector organizations compared with quantified 

economic benefits of making documentation more efficient. 

Rate of Adoption 

Scenario 1, 

Set by Survey 

Scenario 2, 

Slowed 50% 

Scenario 3, 

Measure, 2011–2023 Only Slowed 67% 

Note: Ultimate penetration estimated to be 75.2% (pediatrics), 68.2% (family practice), 62.0% (obgyn), 53.3% (internal medicine), and 50.2% (health departments). 

Economic impacts were quantified for vaccine manufacturers, primary care providers, LHDs, 

AAP, and CDC. Economic benefits associated with saving time during record keeping were 

used in the comparison with economic costs incurred by manufacturers, providers, and 

public-sector stakeholders. Other potential benefits not included in this model because of 

the inability to accurately quantify them were reductions in extraimmunization, more 

efficient inventory management, improved immunization data capture in IIS and other 

information systems, and enhanced product recall capabilities. Thus, the results are 

conservative. 

ES-10 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rate of Adoption 

Scenario 1, Scenario 2, Scenario 3,

Measure, 2011–2023 Only Set by Survey Slowed 50% Slowed 67% 

Total benefits (million $) 447.02 429.00 410.96 

Total costs (million $) 113.95 95.41 101.30 

Total net benefits (million $) 333.08 333.59 309.67 

Net present value (3% discount rate) (million $) 260.62 258.85 237.95 

Net present value (7% discount rate) (million $) 190.34 186.87 169.24 

Benefit-cost ratio (3% discount rate) 3.6 4.0 3.6 

Benefit-cost ratio (7% discount rate) 3.2 3.5 3.1 

Internal rate of return 53% 50% 45% 

 

 

 

 

Executive Summary 

We calculated costs for immunizers under three scenarios. The scenarios present a range of 

expected benefit because although we expect practices to follow their stated preferences to 

use 2D barcodes, it is possible that they may not be able to do so. Therefore, we allowed 

the accrual of economic benefits to slow by 50% and 67% under the possibility that 

providers may take two to three times as long to begin using the 2D barcodes. 

The results presented in Table ES-4 must be interpreted cautiously because fewer than 100 

valid survey responses were received for both ob-gyn and internal medicine practices. Table 

ES-5 presents the same measures as Table ES-4 but excludes ob-gyn and internal medicine 

practices. Note that although net benefits are reduced, costs fall by a larger percentage and 

the benefit-to-cost ratio increases to >3.1, depending on the rate of adoption. Pediatric and 

family medicine practices are higher volume immunizers than other primary care specialties 

and are expected to accrue higher net benefits, explaining the increase in measures of 

economic return when ob-gyn and internal medicine are excluded. 

Table ES-5.	 Summary Public Measures of Economic Return (Excluding Ob-Gyn and 

Internal Medicine Practices) 

Costs for vaccine manufacturers, primary care providers (pediatrics and family medicine only), health 

departments, and public-sector organizations compared with quantified economic benefits of making 

documentation more efficient. Excludes estimated costs and benefits for ob-gyn and internal medicine 

practices because of lower response rates for these specialties. 

Note: Ultimate penetration estimated to be 75.2% (pediatrics), 68.2% (family practice), and 50.2% 

(health departments). 

ES.8 Summary Conclusions, Limitations, and Recommendations 

Our research leads us to conclude that 2D barcodes for vaccine primary packaging will have 

substantial net benefits for stakeholders in the U.S. immunization system (Table ES-6). 

Scanning 2D barcodes is expected to enhance patient safety, lower the cost of documenting 

immunizations, and increase the quality and coverage of data housed in myriad information 

systems. 

ES-11 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Executive Summary 

Table ES-6. Benefits and Costs of Transitioning to 2D Barcodes for Primary 

Packaginga 

Benefits	 Costs 

Automated identification of vaccine products using 

2D barcodes offers the following advantages: 

 enhanced patient safety by ensuring that the 

patient is being administered the correct 

product 

 streamlined documentation and recordkeeping procedures 

 more accurate and complete immunization 

records 

 better data quality for downstream uses of 

immunization data for surveillance and safety 

such as immunization information systems 

(IIS) and the Vaccine Adverse Event Reporting 

System (VAERS) 

 improved vaccine recall and withdrawal 

processes and 

 enhanced inventory management 

2D barcodes also have cost implications for 

stakeholders that must be considered 

throughout the immunization system: 

 upgrading the printing and imaging 

functionalities of manufacturers’ vaccine 

product packaging and labeling lines 

 purchasing scanners, adapting immunization 

workflows, and training of immunizers to use 

scanners to capture product data 

 developing capabilities for information 

systems to ensure that product data 

captured from barcodes are interpretable 

and may be exchanged correctly 

 providing education, training, and 

troubleshooting support to immunizers 

a

IIS (immunization information systems), VAERS (Vaccine Adverse Event Reporting System) 

However, despite the positive results, a number of notable limitations to this analysis must 

be considered when reviewing and acting upon our results: 

 Economic benefits are based on forecasts, and underlying these forecasts are market 

trends, stakeholder perceptions, costs, and other factors that are subject to change. 

 Results only reflect 7 of 11 manufacturers with FDA-licensed products on the market 

in the United States in 2011, and 2 of those 7 did not have implementation plans. 

 Survey data were collected using a survey that received large numbers of responses 

but did not rely on a representative sample of the national population of 

immunization providers or other potential 2D barcode users. 

 Economic benefits and costs for complementary immunizers, including pharmacists, 

RBCs, and mobile immunizers, were not included. 

 Not all economic benefits were quantified, particularly changes in extraimmunization 

rates, improvements in inventory management, and improved immunization 

surveillance. 

 There may be unexpected and unintended benefits and costs that emerge during 

implementation or routine use of 2D barcodes. 

A key focus in our analysis was on data exchange standards. Although data exchange 

standards can accommodate the 2D barcode, implementation of 2D barcoding for vaccine 

products will require a comprehensive mapping of GTINs to the delimited NDCs and CVX 

and MVX. These mapping tables should support all vaccine products on the market both on 

the public side as well as the private-purchase side. Including Current Procedural 

ES-12 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Executive Summary 

Terminology (CPT) codes would facilitate billing; thus, it would be advantageous to include 

them in the mapping table. Programming efforts, education, and coordination with 

stakeholders are needed to use 2D barcodes across immunization encounters, inventory, 

billing, and other tracking systems used for immunization. Specific recommendations follow 

(see also Table ES-7). 

Table ES-7. Summary of Recommendationsa 

Recommendation	 Rationale 

Maintain GTIN to NDC to CVX and 

MVX mapping table 

Enable legacy systems to be populated with 2D-barcoded data; 

support data exchange and interoperability. 

Collaborate with GS1	 Ensure consistent messaging to stakeholders; obtain access to 

GTIN registry. 

Collaborate with the FDA	 Obtain NDC data for mapping purposes; ensure consistent 

messaging to stakeholders. 

Collaborate with AAP	 Collaborate with AAP and other associations in development and 

roll-out of training and outreach programs; maintain participation 

in AAP 2D barcoding working group meetings. 

Education and outreach 

Technical guidance	 Provide specifications so that systems can be developed and tested 

to accommodate 2D barcoded data. 

Implementation	 Provide educational materials and training for end users. 

Change management 

Stakeholder engagement	 Ensure that roles and responsibilities among stakeholders are 

clear. Keep stakeholders engaged to facilitate their members’ 

involvement and ensure that changes are communicated. 

Update 2.5.1 guide	 The 2.5.1 guide is the HL7 source for immunization information 

exchange; incorporating barcoding guidance into the guide will 

ensure that stakeholders are aware of changes. 

Pilot implementation	 Pilot implementation will test 2D barcodes in use, especially with 

EHRs and IIS, so that troubleshooting can occur prior to largescale implementation. 

a

GTIN (Global Trade Item Number), NDC (National Drug Code), CVX (product identifier), MVX 

((manufacturer identifier), FDA (Food and Drug Administration), AAP (American Academy of 

Physicians), EHR (electronic health record) 

We recommend ongoing collaboration among CDC, AAP, GS1, the FDA, and other 

stakeholders to ensure that all parties responsible for the GTIN, NDC, and CVX and MVX 

understand the data exchange implications of the 2D barcode for stakeholders in the 

immunization domain. Coordination and discussion are particularly important during 

implementation and ongoing maintenance. 

One concern that has been universally mentioned is the importance of education and 

training of those who will print, maintain, and use the barcode. Each person will need to 

understand the content of the standards mapping to make necessary changes to their 

systems. Thus, CDC should ensure that the mapping is readily available and communicated 

ES-13 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Executive Summary 

to all stakeholders, especially to information systems vendors and those in the health IT 

technical and policy community. 

A commonly cited concern of interviewees was how changes will be accommodated in the 

future. Vaccines themselves could change, such as when new products come on the market, 

or manufacturers could change. Sometimes the standards themselves change. For example, 

the HL7 standards are updated periodically. The regulatory environment might also change, 

such as the new Health Insurance Portability and Accountability Act (HIPAA) transactions 

and the updates to the privacy and security rules. In addition, vendor products and 

functionalities could change as the meaningful use criteria continue to evolve. Regardless of 

the source of change, a consistent way of citing and accommodating future change in 

standards or barcode content is necessary. This issue points to the need for more consistent 

communication channels for stakeholders throughout the health care delivery system. 

Although we have conducted interviews and document review, testing an implementation is 

the best way to fully understand how the 2D barcode will be operationalized in practice. We 

recommend conducting a staged pilot to test implementation, with an emphasis on 

information systems integration and usage at the practice level and data exchange between 

provider locations and IIS. The pilot should also be part of a technical assistance program 

that reviews functionality and capabilities for IIS and guides or supports implementation. 

The results of the pilot can be used to test information systems, work flows, and educational 

materials. 

ES-14 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1. INTRODUCTION AND BACKGROUND 

Vaccine product labels must be compliant with U.S. Food and Drug Administration (FDA) 

labeling requirements. Since 2004, one of those requirements has been the inclusion of a 

linear barcode containing a pharmaceutical product’s National Drug Code (NDC). The intent 

of the rule was to avoid adverse events by using machine-readable codes when preparing 

medicines for patients (Bar Code Label Requirement for Human Drug Products and Biological 

Products, 2004). 

The objective of FDA’s linear barcode requirement was patient safety, yet according to the 

National Childhood Vaccine Injury Act (NCVIA) (1986), documentation for immunizations 

must include product, manufacturer, and lot number information. Recording of expiration 

date is recommended by the American Academy of Pediatrics (AAP) (AAP Committee on 

Infectious Diseases, 2012). Encoding all these data in a linear barcode would make that 

barcode too large for a 0.5 mL single-dose vial. In a question submitted to the FDA in 2006, 

a party asked whether it would be acceptable to include lot number and expiration date 

along with the NDC in a two-dimensional (2D) barcode. The FDA responded that printing 

and reading technologies were not yet cost-effective; therefore, the barcode must be linear, 

but also that it would consider future revisions (FDA, 2006). 

Five years later, AAP launched its Vaccine Barcoding Initiative, bringing together physicians, 

vaccine manufacturers, and public health groups (including the Centers for Disease Control 

and Prevention [CDC]) to review the feasibility of transitioning to 2D barcodes. AAP’s 

rationale was that costs had decreased sufficiently, that technologies had matured, and that 

accelerating rates of electronic health record (EHR) adoption made 2D barcodes cost 

effective and would constitute a significant gain in patient safety (AAP, 2010). In January 

2010, AAP recommended to the FDA that the agency permit the use of alternative 

symbologies for vaccine product labeling. 

In August 2010, the FDA issued draft guidance to permit the use of “alternative 

symbologies” on vaccine products, including 2D barcodes (FDA, 2010a). That draft guidance 

cited as justification increases in the number of recommended immunizations, recordkeeping requirements of the NCVIA, and changes in technology availability and cost. This 

guidance was finalized in August 2011 (FDA, 2011). 

During the intervening period between draft and final FDA guidance, in October 2010, CDC’s 

Immunization Services Division contracted with RTI International, an independent not-forprofit research institute, to study the impacts a transition to 2D barcodes appearing on the 

label on the unit of use containing product, expiration date, and lot number may have on 

1-1 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chapter 1 — Introduction and Background 

vaccine production, clinical documentation, and public health reporting and tracking. The 

study included an economic analysis and an information systems analysis.1 

Automated identification of vaccine products are expected to offer the following advantages: 

 enhanced patient safety, by using automated identification to ensure that the patient 

is being administered the correct product, thereby avoiding the administration of 

invalid or unnecessary doses; 

 streamlined documentation and record-keeping procedures, by using imaging 

technology to capture data from labels and populate EHRs, practice management 

systems, and other information systems rather than entering these data by hand; 

 more accurate and complete immunization records, by avoiding transcription errors 

from manual data entry and ensuring that the expiration date and lot number are 

entered into the record; 

 better data quality for downstream uses for surveillance and safety, such as 

immunization information systems (IIS), the Vaccine Adverse Event Reporting 

System (VAERS), and the Vaccine Safety DataLink (VSD); 

 enhanced inventory management, by permitting practices to scan dosing units into 

inventory software; and 

 more efficient records review in the event of a vaccine recall. 

2D barcodes also have cost implications throughout the immunization value chain that must 

be considered: 

 upgrading the printing and imaging functionalities of manufacturers’ vaccine product 

packaging and labeling lines; 

 purchasing scanners, adapting immunization workflows, and training immunizers to 

use scanners to capture product data; 

 developing information system functionalities to ensure that product data captured 

from 2D barcodes are interpretable and can be exchanged correctly across all 

immunization reporting systems via data exchange standards; and 

 providing educational, training, and troubleshooting support to more than 30,000 

pediatric, family health, internal medicine, and obstetric-gynecology (ob-gyn) 

practices; nearly 4,000 health departments; and thousands of pharmacies, retailbased clinics (RBCs), and mobile immunization sites across the United States. 

1.1 Project Scope and Objectives 

This study analyzed the impact of adding 2D barcodes to vaccine product labels appearing 

on primary packaging (e.g., the unit of use, such as a single-dose vial or prefilled syringe). 

1

Contract number GS10F0097L, awarded October 1, 2010, with a period of performance to September 

30, 2011, and extended through March 31, 2012. 

1-2 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chapter 1 — Introduction and Background 

Stakeholders included in the study were vaccine manufacturers, vaccine users (e.g., 

immunization providers, immunization program managers), and immunization data users 

(e.g., immunization information systems, data exchange groups, vaccine-related tracking 

systems). Because of the breadth of immunization providers in the United States, the scope 

for all quantitative analyses was narrowed to primary care providers (pediatric, family 

medicine, internal medicine, ob-gyn practices) and health departments. Impacts for other 

immunizers were reviewed qualitatively. 

This study had three overarching objectives, which were organized into tasks: 

1.	 Stakeholder engagement to document knowledge, attitudes, and beliefs 

about the impacts and implications of 2D barcodes for automated identification of 

vaccine products. Methods included semistructured interviews with representatives of 

all stakeholder groups and an internet survey of immunization providers. 

2.	 Prospective economic impact analyses to assess economic benefits and costs 

and the distribution of these costs and benefits across stakeholders. We converted 

the results from the first task into economic models to analyze costs and benefits. 

The models developed analyzed the period from 2011 through 2023, which is 10 

years beyond a predicted barcode availability date of late 2012 or early 2013. 

3.	 Data exchange analysis and information technology standards mapping to 

assess technical feasibility and identify any gaps in the technology infrastructure 

supporting standards-based exchange of immunization data. We reviewed health 

information exchange and data standards relevant to 2D barcodes to assess how 

information can be transmitted across stakeholders. The product of this analysis was 

a feasibility assessment and a series of recommendations about how to incorporate 

the information captured from the barcode into both the relevant standards and the 

guidance. This way, not only will information be captured appropriately, but also 

users will understand what to do with it and how to incorporate it into their systems. 

This issue is particularly important as the United States moves from a largely paperbased records system to an electronic one. 

1.2	 2D Barcoding of Product, Expiration Date, and Lot Data Using 

GS1 Product Identification Standards 

2D barcodes have the potential to improve the accuracy and efficiency of documentation for 

immunization. Information that is currently handwritten, typed into a computer, or both 

could be automatically captured by an imaging device or scanner. This information could 

then populate an EHR, practice management system, or IIS or a record could be printed and 

placed in a paper file. 

As mentioned previously, immunization documentation includes product identification, 

expiration date, and lot number. Product identification entails both the antigen and the 

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Chapter 1 — Introduction and Background 

manufacturer.2 A 2D barcode allows for the inclusion of both static (i.e., manufacturer and 

product name) and variable information (i.e., lot number and expiration date). A 2D 

barcode allows for the inclusion of this information in a single symbol appearing in the 

limited space available affixed to a label on a single-dose vial containing about 0.5 mL of 

product. 

Vaccines currently include a linear barcode with the NDC (Figure 1-1) on the immediate 

container label (or on intermediate packaging if curvature or space is not available). These 

barcodes do not include the lot number and expiration date. Thus, this information must be 

recorded by hand or keyed into a software system. 

Figure 1-1. Example Linear and 2D Barcodes 

Example of linear barcode 

Current linear barcodes required by the FDA 

contain only the vaccine product identification 

information. 

Example of 2D barcode 

A 2D, or data matrix, barcode can include product 

identification information as well as expiration 

date and lot number. 

AAP, Canada’s Automated Identification of Vaccine Products Advisory Task Group (AIVP 

ATG), and other countries’ groups are recommending the use of internationally-standard 

product identifiers, particularly the Global Trade Item Number (GTIN). GS1, a global product 

identification standards organization, created the GTIN to identify products as they move 

from the manufacturer to end-user use. 

For prescription pharmaceutical products in the United States, the GTIN is a 14-digit 

numerical identifier with the NDC embedded in it. The expiration date is in the YYMMDD 

format, as per the GS1 Healthcare US guidelines (GS1, 2011a). The lot number is a variable 

number of digits assigned by the manufacturer. AAP collaborated with GS1 to develop 

guidance for vaccine manufacturers on using GS1 standards for vaccine products. A 

principal advantage of using GTINs is that they must be registered with GS1 to ensure that 

a GTIN only refers to one specific product. Chapter 6 explores GTINs and NDCs in greater 

detail. 

1.3 Relationship of 2D Barcoding to Serialization Initiatives 

2D barcoding of vaccine product, expiration date, and lot number on unit-of-use vaccine 

product labels is a primary packaging initiative that complements and does not conflict with 

2 Although funding source is commonly documented (Vaccines for Children [VFC] or non-VFC), that 

information will not be part of the barcode because the barcode will be applied at the point of 

manufacture, and it is not possible to know the funding source at that time. 

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Chapter 1 — Introduction and Background 

other initiatives, such as serialization and track and trace, that will affect the secondary 

packaging (e.g., unit of sale) and higher packaging levels. 

Serialization refers to the inclusion of a unique serial number on a saleable package that 

allows manufacturers, distributors, and regulatory bodies to assess the pedigree of that 

package. For sale and shipment, vials and syringes are packaged in cartons, boxes, and 

pallets, and it is these packaging levels that may be affected by serialization initiatives in 

the United States. The product label appearing on the vial should not be affected by 

serialization or track and trace because an individual vial or syringe without a box is not a 

saleable unit. 

In FDA’s guidance for industry, Standards for Securing the Drug Supply Chain— 

Standardized Numerical Identification for prescription Drug Packages, the FDA states, 

[e]vidence that a unit is intended for individual sale, and thus constitutes a 

separate “package” for purposes of this guidance, would include the package 

being accompanied by labeling intended to be sufficient to permit its 

individual distribution. For example, if a manufacturer’s smallest unit of sale 

package is a container holding six drug-filled syringes, a single SNI 

[standardized numerical identifier] would be the package-level identifier for 

the container holding the six drug-filled syringes; there would be no SNIs for 

the individual syringes, not intended by the manufacturer for individual sale. 

(FDA, 2010b, p. 3). 

Secondary, tertiary, and other packaging levels, which are expected to be affected by 

serialization, are outside of the scope of this study. Yet it is important that stakeholders 

recognize that 2D barcoding of the unit-of-use and serialization of higher packaging levels 

both affect manufacturers’ packaging operations. 

1.4 Automated Identification of Vaccine Products Initiatives 

The 2D barcoding initiative is occurring as part of a global trend toward automated 

identification of pharmaceutical products in health care settings. In this section, we review 

past and current initiatives that are relevant, including the Vaccine Identification Standards 

Initiative (VISI), the FDA Barcoding Rule (Bar Code Label Requirement for Human Drug 

Products and Biological Products, 2004), AAP’s Vaccine Barcoding Initiative, Canada’s 

Automated Identification of Vaccine Products Advisory Task Group, and current and future 

product identification initiatives in the United States and abroad that have implications for 

the United States. 

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Chapter 1 — Introduction and Background 

1.4.1 Vaccine Identification Standards Initiative (VISI) 

VISI was launched in 1997 by CDC’s Immunization Safety Office in concert with other 

immunization stakeholders to enhance the safety of vaccination through improving accuracy 

of vaccine information. Safety enhancements were expected to accrue via development and 

dissemination of uniform guidance for administrative functions of vaccines, including 

packaging, labeling, and record keeping. 

VISI proposed guidelines in six areas: peel-off labels, barcoding, uniform vaccine 

administration record, NDC vaccine database, vaccine facts sidebar, and standard 

abbreviations for vaccine and antibody types, manufacturers, and distributors (Grabenstein, 

2002). 

Although the group made progress, including the adoption of peel-off labels by some 

manufacturers for portions of their product portfolios, FDA’s Barcode Label Requirement for 

Human Drug Products and Blood: Final Rule (69 FR 9120) ultimately superseded the VISI 

initiative by specifying barcode labeling requirements. Implementing 2D barcoding builds on 

the initial goals of VISI to improve vaccine safety and streamline documentation. 

1.4.2 Food and Drug Administration’s Barcoding Rule (CFR 69 FR 9120) 

On March 14, 2003, the FDA introduced a proposed rule (Bar Code Label Requirement For 

Human Drug Products and Blood, 2003) that required prescription human drug products, 

including vaccines, to be labeled with a linear barcode. The rule followed an Institute of 

Medicine (IOM) report entitled To Err Is Human: Building a Safer Health System, which 

estimated the number of American deaths as a result of medication errors in 1993 at 7,000 

(Kohn, Corrigan, & Donaldson, 2000).3 IOM noted that many of these deaths were likely 

easily preventable and suggested barcoding as a solution. A timeline of important barcoding 

events is displayed in Table 1-1. 

In the Federal Register of February 26, 2004, the FDA published the barcoding final rule 

(Bar Code Label Requirement for Human Drug Products and Biological Products, 2004). The 

rule became effective April 26, 2004, and specifies that the barcode must 

 be linear, 

 include the drug’s NDC, 

 meet European Article Number/Uniform Code Council or Health Industry Business 

Communications Council standards, 

3

In 2005, the IOM released a follow-up report entitled Five Years After ‘To Err Is Human’: What Have 

We Learned?, which stated that, although small positive impacts had been observed and the 

groundwork for safety improvements had been laid, there was little national impact and progress 

was slow. 

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Year 

1997 CDC launches the VISI 

1999	 IOM: To Err Is Human: Building a Safer Health System: Described safety problems in 

the administration of pharmaceutical products and established the concept of the 5 

rights 

2003	 FDA: Barcode Label Requirement for Human Drug Products and Blood: Proposed Rule 

(68 FR 12500): Proposed that all pharmaceutical products include a linear barcode on 

packaging labels 

2004 FDA: Barcode Label Requirement for Human Drug Products and Blood: Final Rule (69 FR 

9120): Finalized linear barcode requirement 

2005	 IOM: Five Years After ‘To Err Is Human’: What Have We Learned?: Reaffirmed that 

safety challenges associated with medicine administration remain prevalent in the 

United States 

2006	 FDA: Guidance for Industry: Barcode Label Requirements—Questions and Answers (71 

FR 58739): Stated that alternative symbologies to the linear barcode are not costeffective or permitted 

2010	 FDA: Draft Guidance for Industry: Barcode Label Requirements—Questions and Answers 

(Question 12 Update); Availability (75 FR 54347): Stated that the FDA may consider 

issuance of waivers to permit 2D barcodes for vaccine products 

2011	 FDA: Final Guidance for Industry: Barcode Label Requirements—Questions and 

Answers: Availability (76 FR 49772): Stated that the FDA will accept requests to waive 

the linear barcode requirement in favor of including a 2D barcode for vaccine products 

only 

2011 AAP and GS1: American Academy of Pediatrics & GS1 US Guideline for Suppliers: The 

Application of GS1 DataMatrix Barcodes to Vaccines for Point-of-Care: Established the 

AAP-approved specification of GTIN, expiration date, and lot number as data fields for 

2D barcodes for vaccine product labels affixed to the unit of use in the United States 

 

 

 

 

 

 

 

 

 

Chapter 1 — Introduction and Background 

 be surrounded by enough blank space to allow it to be scanned correctly,
 

 outlast normal use, and
 

 be placed on both the drug’s immediate container label and the outside packaging 

label, unless the immediate label is machine-readable through the outer packaging. 

Table 1-1. Timeline of Important Vaccine Barcoding Legislation and Guidance 

Legislation and Guidance 

In the final rule (Bar Code Label Requirement for Human Drug Products and Biological 

Products, 2004), the FDA stated that they were unable to justify mandating inclusion of 

expiration date and lot number in the barcode based on current knowledge of the costs and 

benefits of including this information. 

On October 5, 2006, the FDA released a document entitled Guidance for Industry: Barcode 

Label Requirements—Questions and Answers. Question 12 of the document asks whether a 

manufacturer may use an alternative symbology, such as a 2D barcode, instead of a linear 

barcode. The FDA reiterated that a linear barcode must be used but added that they will 

consider future revisions to the rule. 

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Chapter 1 — Introduction and Background 

1.4.3 American Academy of Pediatrics Vaccine Barcoding Initiative 

AAP supports the implementation of 2D barcodes and presented their perspective in a 

presentation to the FDA on February 2, 2010. AAP requested the inclusion of the GTIN, 

expiration date, and lot number in vaccine barcodes (AAP, 2010). AAP noted that the 

transition to 2D barcodes has become necessary since the 2004 FDA rule for a number of 

reasons, including the following: 

 the number of recommended vaccines has increased since the original rule in 2004, 

and several combination products have been introduced; 

 the number of private practices using EHRs has increased; 

 2D barcodes, even in areas such as retail, are moving toward becoming the
 

standard; and
 

 the cost of printing and scanning 2D barcodes has decreased (AAP, 2010). 

During 2010 and 2011, AAP led a working group of vaccine manufacturers, immunization 

providers, and public health agencies to further 2D barcoding, including establishing 

consensus standards, convening discussion panels, and developing guidance for 

manufacturers and guidance and training programs for providers. AAP coordinated with GS1 

to provide written, AAP-approved guidance to manufacturers and clinicians (GS1, 2011a).4 

1.4.4 Food and Drug Administration’s Updated Question 12 Guidance 

In August 2010, the FDA issued a revision to the 2006 document entitled Draft Guidance for 

Industry: Barcode Label Requirements—Questions and Answers; Availability, stating that 2D 

barcode technology had advanced to the point that the benefits of 2D technology may 

exceed costs. The FDA stated that since the finalization of the original rule it has become 

clear that 2D barcodes could play an important role in safe and efficient vaccination. 

The document notes that sites administering childhood vaccines may particularly benefit 

from 2D barcodes, given that these locations are bound by the NCVIA and often have little 

administrative support. NCVIA requires that the date the vaccine was administered; the 

manufacturer; lot number of the vaccine; and the name, address, and title of the person 

administering the vaccine be recorded. Administrators must log all information not stored in 

a linear barcode manually, a process that is time consuming and prone to error. Errors can 

lead to safety issues and expensive duplicate vaccinations. 

The FDA (2011) finalized the vaccine industry guidance in August 2011 called Guidance for 

Industry: Bar Code Label Requirements—Questions and Answers; Availability. The guidance 

4 AAP facilitated meetings between stakeholders to obtain feedback on draft guidance. At these 

meetings the guidance was reviewed, comments were solicited, and changes from earlier versions 

were outlined. 

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Chapter 1 — Introduction and Background 

opened the door for manufacturers to submit requests to use alternative symbology, 

including the 2D barcode. It allows for the vaccine products to replace linear barcodes with 

2D barcodes, if granted a waiver by the FDA. Childhood vaccines were cited as a reason for 

this guidance, but the guidance applies to all vaccines. It is important to note that the FDA 

stated specifically that its guidance does not apply outside of vaccine products and that it 

applies only to the unit-of-use. Linear and 2D barcodes may be placed on a label together. 

1.4.5	 Automated Identification of Vaccine Products (AIVP) Advisory Task 

Group (Canada) 

Efforts related to vaccine barcoding have been ongoing in Canada since 1999, when the 

National Advisory Committee on Immunization passed a resolution recommending that 2D 

barcodes be included on vaccines. This resolution came about after the Public Health Agency 

of Canada (PHAC) released information showing that up to 10% of the population was being 

reimmunized because of faulty immunization records, resulting in unnecessary costs and 

health consequences (HDR, 2009).Canada established the AIVP ATG to develop solutions 

leveraging information systems technologies.5 This group completed feasibility studies on 

vaccine barcoding alternatives, ran a pilot project to demonstrate the benefits of automated 

identification for inventory management, and met with manufacturers to develop a list of 

necessary standards. The Canadian initiative is notable because many products and 

manufacturers are common across the United States and Canada, and, like AAP, the AIVP 

ATG is also requesting that GTIN and lot number are in a 2D barcode (Public Health Agency 

of Canada and GS1 Canada, 2010). 

In 2009, PHAC completed a commissioned study entitled “Cost-Benefit Analysis for Adoption 

and Implementation of the Automated Identification (Bar Coding) of Vaccine Products” 

(HDR, 2009). The study estimated the direct and indirect costs and benefits of 

implementing barcode standards and establishing a Vaccine Identification Database System 

(VIDS) for all vaccine products in Canada. It analyzed six different labeling scenarios (HDR, 

2009). The most comprehensive scenario, recommended by the Canadian Immunization 

Registry Network, includes a 2D barcode on the primary package, a linear or 2D barcode on 

the secondary package, and two peel-off labels with barcodes and human-readable 

information on the primary package. The benefit-cost ratio for this scenario was estimated 

at 4.0, and the net present value (NPV) estimate was C$797 million. The most cost-effective 

scenario (requiring a static data barcode on primary and secondary packages) was 

projected to have a benefit-cost ratio of 8.2 and an NPV of C$919 million. 

5

Voting AIVP ATG Members include BIOTECanada, Canadian Immunization Registry Network, Canadian 

Nurses Coalition on Immunization, Canadian Pediatric Society, Canadian Information Technology 

Associations of Canada, Canadian Medical Association, GlaxoSmithKline, GS1 Canada, Health 

Canada, Institute for Safe Medication Practices Canada, Merck Canada Ltd., Novartis 

Pharmaceuticals Canada, Pfizer Canada, Public Health Agency of Canada, Sanofi Pasteur Ltd., and 

Solvay Pharma Inc. 

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Chapter 1 — Introduction and Background 

Although the costs and benefits discussed in the Canadian study provide a good framework 

for implementing a 2D barcode in the United States, the Canadian study examines a far 

broader and more comprehensive initiative. For example, costs assessed in the Canadian 

study include development of a vaccine inventory management database to store data on 

vaccines, reconfiguration of the centralized database that combines records on vaccines 

from providers to incorporate barcodes, and ongoing collection of vaccine data. The study 

also included benefits from reduced wastage and extraimmunization, as well as streamlined 

public-sector vaccine inventory management. 

Implementation of vaccine barcoding in Canada also differs from implementation in the 

United States, in large part because health care is regulated by the 10 provinces and 3 

territories, so less coordination is needed than in the United States, where regulation occurs 

in all 50 states. In addition, the health care system in Canada is largely public, and most 

vaccines are paid for by provincial/territorial governments. There is a single purchasing 

group, the Vaccine Supply Working Group, and one distribution system in each province and 

territory. 

1.5 Initiatives Outside of North America 

The United States and Canada are not alone in pursuing pharmaceutical product 

identification initiatives. Although underlying rationales and operating models differ by 

country, a common factor is often a decision to leverage GS1 standards (Table 1-2). See 

Appendix A for a description of initiatives occurring outside of North America. 

Table 1-2. Countries with Known Automated Prescription Pharmaceutical 

Product Identification Initiatives Outside of the North America, as of 

August 2011 

Argentina Germany South Korea 

Belgium Greece Sweden 

Brazil India Turkey 

China Italy United Kingdom 

France 

Note: See also Appendix A. 

1.6 Report Organization 

This report is organized as follows: 

 Chapter 2, Literature Review, presents a synthesis of the literature organized 

thematically: barcoding in health care, immunization practice, and electronic data 

exchange. Because 2D barcodes for vaccines have yet to be introduced to the 

market, we reviewed relevant literature from the perspective of how eliminating 

human error from verifying that the correct product is being administered to the 

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Chapter 1 — Introduction and Background 

correct patient and from recording product, lot, and expiration date could enhance 

safety and efficiency. 

 Chapter 3, Impact on Vaccine Production, analyzes the perspectives of 

manufacturers and presents a benefit-cost analysis for 2011 through 2023, with 

2023 being the end point of a 10-year period of 2D barcode availability. The results 

indicate that five manufacturers plan to implement 2D barcoding at a cost of $30.6 

million. 

 Chapter 4, Knowledge, Attitudes, and Beliefs of Primary Care Providers and 

Local Health Departments (LHDs), describes the results from semistructured 

interviews and an internet survey. Nearly 3,700 valid survey responses were 

received. When presented with descriptions of potential benefits and costs, over 70% 

of pediatric and family medicine practices indicated they would use the barcode or 

that they would use it when they have an EHR system in place. In contrast, only 

39.2% of LHDs said they would use it. 

 Chapter 5, Economic Analysis of the Impact of 2D Barcodes on Clinical 

Documentation, presents a benefit-cost analysis of adopting and using 2D barcodes 

to record product, expiration date, and lot number information in primary care and 

LHD settings. Only benefits from more efficient documentation were able to be 

quantified, yet we included comprehensive cost estimates. Results are, therefore, a 

lower bound. We estimate that 2D barcodes would decrease time spent on 

documentation by 58% to 63% per dose. Despite adoption costs, net benefits to 

primary care providers and LHDs are expected to be $311 million to $333 million 

between 2013 and 2023. 

 Chapter 6, Impact on Exchange and Management of Immunization 

Information, reviews issues surrounding standards-based data exchange and maps 

fields and identifiers for relevant standards to assess feasibility. Ultimately, we 

concluded that in order to maximize the promise of 2D barcodes, a mapping of GTIN 

to NDC to CDC’s manufacturer identifier (MVX) and product identifier (CVX) is 

required. 

 Chapter 7, Impacts and Implications for Other Stakeholders in the U.S. 

Immunization Ecosystem, reviews how the transition to 2D barcoding of vaccine 

product labels could affect complementary immunizers, public health authorities, and 

other stakeholders in the immunization system. Pharmacists, RBCs, and other 

immunizers were consulted for this work, and it became apparent from our 

interviews that pharmacies and RBCs are likely 2D barcode users. 

 Chapter 8, Summary Results and Conclusions, presents summary remarks and 

recommendations. A lower-bound benefit-to-cost ratio of 2.7 to 2.8 was estimated, 

meaning that for every $1 invested in 2D barcoding at least $2.70 is expected to 

accrue between 2011 and 2023. 

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2. LITERATURE REVIEW 

In an effort to clarify the potential impact(s) of adding a 2D barcode to vaccine product 

labels, we conducted a targeted literature review and scan of unpublished grey literature. 

Because 2D barcodes for vaccines had yet to be introduced to the market when this study 

launched in October 2010, we reviewed relevant literature from the perspective of how the 

following could enhance patient safety and efficiency: 1) eliminating human error from 

verifying that the correct product is being administered to the correct patient and 

2) recording product, lot, and expiration date accurately and completely. We synthesized 

evidence from the literature into 3 categories: impacts of barcoding on health care, current 

immunization practice, and electronic data exchange (Table 2-1). 

Table 2-1. Summary Literature Review Findings 

Category Relevance to Vaccine Barcoding Literature Highlights 

Barcoding in 

health care 

The implementation of barcoding 

technologies in health care settings 

may provide lessons for its 

implementation within immunization 

practice. 

Barcoding has the potential to 

 reduce human errors in record keeping, 

 facilitate response to product recalls, and 

 conduct post-marketing safety 

surveillance. 

Immunization 

practice 

Barcoded vaccines may have a 

significant impact on immunization 

practice. 

Barcoding has the potential to 

 reduce vaccine wastage, 

 reduce extraimmunization, and 

 improve efficiency in record keeping. 

Electronic 

data 

exchange 

2D-barcoded vaccines have the 

potential to facilitate data collection 

and electronic data exchange in a 

variety of settings. 

Barcoding has the potential to 

 improve accuracy and completeness of 

record keeping, 

 facilitate data entry into immunization 

information systems (IIS), and 

 improve the quality of data shared with 

IIS. 

Indirectly, these improvements in the ease 

with which data can be shared and their 

improved quality may increase the amount 

of data included in IIS, as well as public 

health data exchange more generally. 

2.1 Literature Review Methodology 

Our review encompassed health informatics, public health, economics, and industry 

literature because of the crosscutting issues of interest. Peer-reviewed articles were 

identified via indexed databases such as PubMed and EconLit. We also searched unpublished 

grey literature through web-based searches and reviews of materials identified during 

interviews with key informants and stakeholder organizations, including the American 

Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), American 

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Chapter 2 — Literature Review 

College of Obstetrician Gynecologists (ACOG), American Medical Association (AMA), 

Biotechnology Industry Organization (BIO), GS1 Healthcare US, Association of 

Immunization Managers (AIM), and the American Medical Informatics Association (AMIA). 

Searches were performed using a combination of keywords, which included vaccine, 

immunization, barcode, health care, practice, pediatric, obstetric-gynecology (ob-gyn), 

internal medicine, family physician, public health clinic, time–motion, economic, safety, 

medical errors, record keeping, electronic health records, health information technology, 

immunization information system, and data. We excluded articles that were not in the 

English language and those that were specific to developing health care systems (e.g., we 

included references from Australia but not from sub-Saharan Africa). References for these 

sources were catalogued using EndNote X4 software. 

2.2 Barcoding in Health Care 

Barcoding vaccines has the potential to ensure that individuals receive the correct vaccine 

and that the information about the vaccine received is entered accurately into the patient 

record (i.e., preventing medication errors). Collecting this information is critically important 

because of the possibility, however remote, that there may be specific vaccine safety 

concerns following administration. 

2.2.1 Barcoding and Patient Safety 

Health care providers have striven “to do no harm” since Hippocrates. In recent years, 

medical errors, in particular, human errors, have been highlighted as a significant threat to 

patient safety (Kohn, Corrigan, & Donaldson, 2000). The extant literature addressing the 

intersection between barcodes and patient safety predominantly focuses on the adoption 

and implementation of barcode technology to improve the safety of medication 

administration. Barcoding has been advocated as one technological approach to improve 

patient safety by reducing human error. The Healthcare Information Management Systems 

Society (HIMSS) asserts that barcoding is a means to reduce medical errors, as well as 

improve health care quality more broadly (Simpson, 2001).The concept of barcoding 

reducing human error has implications for what may be described as medication errors, 

vaccine management, and the ability to respond to product recalls. 

The literature includes many references to the concept of the “5 rights” when assessing the 

administration of medications (Figure 2-1). Although the 5 rights has its limitations, Bundy 

et al. (2009) used it as a framework to report pediatric vaccination errors. In their study of 

607 outpatient, vaccination errors reported voluntarily to the largest adverse drug event 

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Chapter 2 — Literature Review 

database in the United States, MEDMARX,1 

were evaluated to determine the 

characteristics of the errors and how they 

fit into the 5 rights. 

1.	 Wrong-patient errors in which 

vaccines administered to the wrong 

child occurred rarely (4.4% of
 

administration errors). Bundy et al. 

(2009) estimate more than 40% of
 

wrong-patient errors are related to 

sibling confusion. Wrong-patient 

errors did not reflect vaccines administered to a child for whom the vaccine was 

contraindicated. 

2.	 The wrong vaccine was the error most commonly identified by Bundy et al. (2009). 

They examined errors based on look-alike/sound-alike generic names. The tetanus 

group (DTaP, Tdap, DT, and Td) represented more than one-third of all errors cited. 

Errors also occurred with the pneumococcal and meningococcal groups. Sound-alike 

trade names were hypothesized to be a source of error as well, but the data did not 

permit analysis at this level. 

3.	 The wrong dose includes “wrong drug” (25% of errors), “extra dose” (25%), 

“improper dose/quantity” (14%), and “wrong dosage form” (1%). Extra doses were 

reported as occurring more commonly with scheduled vaccines (as opposed to 

seasonal or electively administered vaccines). Because the data collection permitted 

reporting in more than one category, there may be overlaps in reporting (i.e., a 

given dose error could be reported as “wrong drug” as well as “extra dose” and 

“wrong dosage form”). This highlights the need to critically evaluate such reports. 

4.	 The wrong time was reported among 8% of errors. This category included 

extraimmunization as well as underimmunization. As with extra doses, wrong time 

and “omission” occurred more commonly with scheduled vaccines (as opposed to 

seasonal or electively administered vaccines). 

5.	 The wrong route occurred infrequently (<.5%). 

Figure 2-1. The “5 Rights” to Reduce 

Medication Errors 

 Right patient (the medication is being administered to 

the person for whom it is intended) 

 Right medication (the correct medication is being 

administered) 

 Right dosage (the medication prescribed is 

administered at the correct dosage)

 Right time (the medication is being administered at 

the correct interval)
 

 Right route (the medication is being administered via 

the correct route, e.g., intramuscular vs. 

subcutaneous injection) 

Of further relevance to barcoding, errors occurred in prescribing (11%), transcribing and 

documenting (10%), and dispensing (4.1%) (Bundy et al., 2009). 2D barcoded vaccines’ 

capacity to improve record keeping would likely reduce human errors in “transcribing and 

documenting”; barcoded vaccines’ capacity to be integrated into EHRs and their clinical 

support tools would likely reduce errors in “prescribing” and “dispensing” by identifying 

instances in which a patient may otherwise receive the wrong vaccine (e.g., DTaP instead of 

Tdap) or inappropriate dispensing (e.g., using the wrong diluents). 

1 MEDMARX is an anonymous, deidentified, voluntary national internet-accessible database established 

in 1998. MEDMARX is used by hospitals and health care systems to collect, report, track, and share 

adverse drug events and medication errors in a standardized format. The database includes nearly 

1.4 million medication error reports (MEDMARX, 2011). 

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Chapter 2 — Literature Review 

The study by Bundy et al. (2009) is consistent with Wilton and Pennisi (1994) who found 

that at least 10% of 2,098 children immunized at UCLA’s Children’s Health Center had 

transcription errors in their electronic immunization records. 

Feikema, Klevins, Washington, and Barker (2000) describe extraimmunization as “vaccine 

doses given in excess of the recommended [immunization] schedule.” Implementing a 

system in which 2D-barcoded vaccines improve record keeping has the potential to reduce 

the incidence of extraimmunizations. 

Currently, extraimmunizations commonly occur when immunization providers attempt to 

ensure adherence with the Advisory Committee on Immunization Practices (ACIP)-

recommended immunization schedule and children lack accurate or adequate immunization 

documentation or require updating earlier mistimed doses (Feikema et al., 2000). Likewise, 

extraimmunization of specific antigens can occur in the course of administering a series of 

combination vaccines. 

Estimates of the frequency of extraimmunization vary by vaccine. Feikema and colleagues 

(2000) examined extraimmunization of hepatitis B, DTP/DTaP, Hib, polio, and measles 

vaccines and found a range of weighted percentages by vaccine of 14.1% for polio to 2.5% 

for measles. Strine and colleagues (2002) recognized that the rate of extraimmunization is 

decreasing (from an estimated 1.8 million extra doses in 1997 to 775,000 in 2000) but 

assert the financial impact remains a concern. 

Darden et al. (2001) used data from the National Immunization Survey to estimate rates of 

extraimmunization in children aged 19 to 35 months for the years 1999 through 2003. 

Overall, they found an average extraimmunization rate of 9.4%. Like Strine, they found the 

overall percentage of extraimmunization declined over time and varied by vaccine. 

Extraimmunzation generally results from a lack of adequately documented immunization 

history. We anticipate that the improved record keeping that barcoded vaccines can 

facilitate will result in reduced extraimmunization. 

One benefit of implementing barcode medication administration systems can be summarized 

as reducing preventable errors associated with the “5 rights” and producing data that can be 

used for quality and patient safety improvement initiatives (Akiyama, Koshio, & Kaihotsu, 

2010; Douglas & Larrabee, 2003; Hook et al., 2008; Johnson et al., 2004). 

As described by Akiyama et al. (2010), “in addition to their contribution to the 

authentication of the 5 rights, data captured by barcode administration systems have the 

potential to provide sources of research to improve patient safety in terms of actual 

injections and medications data.” Akiyama et al. studied a sophisticated system that used 

barcodes to capture data on each medical action that took place in the hospital, including 

details about when, where, what, why, for what, to whom, and how each action occurred. 

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Chapter 2 — Literature Review 

These data yielded a rich understanding of the context of errors and enabled them to 

efficiently investigate potential solutions to avoid similar errors in the future. 

Douglas et al. (2003) echoed these sentiments, saying that “this input of previously elusive 

medication error data gives [their] medication error team—as well as [their] pharmacy and 

therapeutics, patient safety, and quality improvement committees—a plethora of 

information from which to devise informative and useful root cause analyses, and 

implement effective quality improvement programs.” 

Johnson et al. (2004) took a step further by explaining how such data on errors and the 

solutions identified from them could ultimately even lead to financial benefits: 

“Understanding the type and circumstances of errors intercepted by BPOC (barcode-pointof-care technology) will provide insight into potential systems issues that cause the errors 

to occur. The resulting reduction in errors will produce a substantial financial benefit by 

reducing costs associated with medication errors.” 

To fully realize the potential benefits of barcodes for patient safety, however, the barcodes 

must actually be used by clinical staff. In other words, clinical workarounds developed as a 

result of technology flaws, failures, inconveniences, and a host of other reasons (e.g., task 

related, patient related, environmental, policy) can undermine or defeat the utility of 

barcode technology from a patient safety standpoint; the workarounds must be identified 

and addressed to ensure compliance (Koppel et al., 2008; McNulty et al., 2009).2 Barriers 

and facilitators that were commonly cited in the literature are summarized in Table 2-2. 

The literature suggests that maximizing the benefits of barcode technology also involves 

selecting a sophisticated system with the capacity to identify various types of potential 

errors; operating the system in conjunction with other sophisticated technologies, including 

electronic medication administration records and computerized physician order entry 

systems rather than in isolation; and incorporating its use into other processes (e.g., 

verification of accurate blood transfusions, identification of laboratory specimens, biologics 

inventory management) (Akiyama et al., 2010; Douglas & Larrabee, 2003; Johnson et al., 

2004). Although many of these reports focus on inpatient settings that do not always reflect 

the outpatient setting in which most immunizations occur, these studies highlight the 

significance of integrating barcoded data collection and reporting within a broader system. 

2

To understand the causes of workarounds, McNulty et al. conducted interviews with frontline nurses 

and their managers, reviewed monthly technical support desk logs to find out what software and 

device issues had been encountered, created and reviewed monthly reports on barcode-scanning 

compliance by unit, and disseminated a staff accountability guide addressing repeated 

noncompliance. Armed with this heightened understanding of the reasons behind workarounds, 

they categorized the issues by type (education, technology, or process) and department (nursing, 

pharmacy, physician, and information technology), developed solutions to overcome the use of 

workarounds, and ultimately were able to achieve and sustain their goal of 95% compliance. 

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Chapter 2 — Literature Review 

Table 2-2. Insights from Literature Regarding Barriers and Facilitators to 

Change That May Affect Adoption and Use of 2D Barcodes 

Barriers	 Facilitators 

 Barcode technology may represent a 

“fundamental” or “radical” change to 

medication administration and 

documentation and can require social and 

cultural changes in the adopting 

organization (Douglas & Larrabee, 2003; 

Hook et al., 2008; McNulty et al., 2009) 

 Initial resistance among some clinical staff 

(Douglas & Larrabee, 2003; Hook et al., 

2008; McNulty et al., 2009) 

 Concerns about the volume of 

alerts/warnings generated by the system 

and time spent responding to them 

(Douglas & Larrabee, 2003; Johnson et al., 

2004) 

 Time and cost associated with barcoding 

actual medications in cases of 

incompatibility with scanners, receipt 

without barcode (prior to mandate or 

despite mandate), or cases in which 

medications need to be repackaged 

(Douglas & Larrabee, 2003; Hook et al., 

2008; Johnson et al., 2004) 

 Development of clinical workarounds3 

(Koppel, Wetterneck, Telles, & Karsh, 2008; 

McNulty et al., 2009) 

 Demonstrating leadership’s commitment to 

patient safety, in general, and specifically to 

successful implementation (Johnson, Hummel, 

Kinninger, & Lewis, 2004; McNulty, Donnelly, & 

Iorio, 2009) 

 Involving ultimate users (i.e., clinical staff) in 

product selection to foster buy-in (Johnson 

et al., 2004) 

 Using a multidisciplinary team approach to 

developing understanding of how 

implementation will affect process flows 

(Douglas & Larrabee, 2003; McNulty et al., 

2009) 

 Using a pilot study or phased implementation 

(Douglas & Larrabee, 2003; Hook, Pearlstein, 

Samarth, & Cusack, 2008; Johnson et al., 

2004; McNulty et al., 2009) 

 Providing a strong training and support system 

(Douglas & Larrabee, 2003; Hook et al., 2008; 

McNulty et al., 2009) 

 Cultivating champion(s) among clinical staff to 

encourage/intervene with reluctant users 

(Douglas & Larrabee, 2003; Hook et al., 2008; 

Johnson et al., 2004) 

 Making benefits visible to staff (i.e., improved 

staff satisfaction and retention) and patients 

(i.e., improved patient satisfaction) (Johnson 

et al., 2004; McNulty et al., 2009) 

In 2011, the American Society of Health System Pharmacists (ASHP) published the “ASHP 

Statement on Bar-Code Verification During Inventory, Preparation, and Dispensing of 

Medications.” ASHP “encourages hospital and health-system pharmacies to incorporate barcode scanning into inventory management, dose preparation and packaging, and dispensing 

of medications.” Their rationale for such scanning technologies is that it will ensure that 

drugs administered are the correct products, are in date, and are not subject to a recall. 

2.2.2 Barcoding and Vaccine Safety Issues 

Separate from patient safety issues, evaluating specific vaccine concerns requires tracking 

who received a given vaccine and any adverse events that may have followed. In addition to 

research studies on the safety of vaccines, tracking who received what product and, 

3

A clinical workaround is a means to respond to a problem or challenge without eliminating the 

problem or challenge. An example of a problem or challenge that might result in a clinical 

workaround is when a clinician is immunizing a patient in a clinical setting that uses an EHR that 

requires data entry into a field for which the clinician lacks the relevant information. A clinical 

workaround for this example could be for the clinician to enter a dummy variable or erroneous 

data. 

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Chapter 2 — Literature Review 

specifically, the lot number of that product, is important, especially when a safety concern 

arises about a specific vaccine lot. Scanning 2D barcodes would add lot data to records 

automatically, which could facilitate recalls and improve data completeness and accuracy in 

Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD). 

As discussed in a later section, IIS can also be used to identify patients who were given a 

recalled vaccine or be used to obtain a lot number when reporting an adverse event. 

The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research 

(CBER) reports recalls of vaccines and biologics: 

Recalls are a firm’s [manufacturer’s] removal or correction of a marketed 

product that the FDA considers to be in violation of the laws it administers 

and against which the agency would initiate legal action, e.g., seizure. Recalls 

may be conducted on a firm’s own initiative, by the FDA request, or by the 

FDA order under statutory authority. (FDA, 2011) 

Between 2005 and 2010, we found a total of 14 recalls out of 138 (10.1%) for biologics that 

were for vaccines (Table 2-3). Although recalls are cause for concern, they do not 

necessarily mean that the vaccine recipient is in imminent danger of harm. Barcodes could 

facilitate recalls by making inventory reviews and identification of patients that may have 

received a recalled product more efficient. Table 2-4 summarizes the reasons for seven 

vaccine recalls in 2010. 

In addition to recall notices, there are also systems for collecting and monitoring vaccine 

safety, notably VAERS and VSD. VAERS is a post-marketing safety surveillance system 

cosponsored by the Centers for Disease Control and Prevention (CDC) and the FDA.4 It was 

created to receive reports about adverse events ranging in severity from mild (e.g., fever, 

local reactions, irritability) to severe (e.g., hospitalization, permanent disability, death) 

occurring after vaccinations (U.S. Department of Health and Human Services [HHS], 

2011a). VAERS’s intent is to identify specific vaccines or vaccine lots that may be associated 

with higher than expected rates of adverse events. However, one limitation of VAERS data 

is the absence of lot numbers in approximately 20% of reports (Kennedy, 2012).5 

4

The National Childhood Vaccine Injury Act (NCVIA) of 1986 requires health professionals and vaccine 

manufacturers to report to HHS specific adverse events that occur after the administration of 

routinely recommended vaccines. In response to NCVIA, CDC and the FDA established VAERS in 

1990 (Chen et al., 1994). 

5

VAERS is a passive surveillance system (meaning that it relies on health care providers, vaccine 

recipients or their guardians, and other sources to identify and voluntarily report adverse events), 

limitations of the data include known underreporting, inconsistent reporting standards and biases in 

reporting, data quality issues (incomplete or inaccurate submissions), and the inability to determine 

causality using the data (HHS, 2011a, 2011b). These limitations mean that VAERS is often 

described as a tool for hypothesis generation rather than epidemiological assessment. 

2-7 
 

 

Date of 

Notification 

Company 

(Location) 

Product 

Brand Name Description Reason for Recall 

12/17/2010 FLUVIRIN (influenza 

virus vaccine) 2010– 

2011 

Novartis Vaccines 

and Diagnostics, Inc. 

(Cambridge, MA) 

Formula multidose 

vials, Lot # 

111812P1 

Cracks in the vial necks 

carry the potential risk of 

compromising product 

sterility 

8/16/2010	 Influenza A (H1N1) 

2009 monovalent 

vaccine 

NDC 49281-640-15 

Sanofi Pasteur 

(Swiftwater, PA) 

5 mL multidose vials Shorter expiration period 

than indicated on the label 

4/13/2010 RabAvert rabies vaccine 

(rabies vaccine for 

human use) kits 

Novartis Vaccines 

and Diagnostics 

(Marburg, Germany)

RabAvert kit batch 

#458011A 

diluent vial batch 

#927011 

The stopper and the metal

crimp dislodge from the 

vial completely when 

removing the protective 

cap 

3/25/2010	 Influenza A (H1N1) 

2009 monovalent 

vaccine, live, intranasal 

MedImmune LLC 

(Philadelphia, PA) 

Expiration date update 

3/22/2010 Prevnar, pneumococcal 

7-valent conjugate 

vaccine 

Wyeth 

(Pearl River, NY) 

0.5 mL single dose 

prefilled syringe (10 

per package) 

Syringes distributed with a 

rubber formulation in the 

syringe tip caps that was 

not approved for use with 

Prevnar 

2/3/2010 Influenza A (H1N1) 

2009 monovalent 

vaccine 

Sanofi Pasteur 

(Swiftwater, PA) 

Prefilled syringes 

UT023AA, UT023BA, 

UT023CA, UT023EA, 

UT023FA 

Prefilled syringes after 

routine stability testing 

determined that those lots 

no longer met the potency 

specification 

1/7/2010 Influenza A (H1N1) 

2009 monovalent 

vaccine, live, intranasal 

MedImmune 

(Philadelphia, PA) 

Expiration date update: 

expiration period different 

than date indicated on the 

label 

Chapter 2 — Literature Review 

Table 2-3. Vaccine and Other Biologic Product Recalls, 2005–2010 

Total Number Vaccine 

and Other Biologic 

Recalls 

Vaccine Recalls as 

Percentage of All 

Biologic Recalls 

Number of Vaccine 

Year Recalls Only 

2005 40 0 — 

2006 19 2 11% 

2007 18 1 6% 

2008 29 0 — 

2009 11 4 36% 

2010 22 7a 32% 

Total 138 14 10% 

a

Additional information for vaccine recalls in 2010 is included in Table 2-4. 

Source: U.S. Food and Drug Administration. Recalls (biologics). Retrieved from 

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/default.htm 

Table 2-4. Vaccine Recalls Reported by CBER in 2010 

Source: U.S. Food and Drug Administration. Recalls (biologics). Retrieved from 

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/default.htm 

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Chapter 2 — Literature Review 

The VSD system is a population-based, active surveillance system (i.e., does not rely on 

voluntary reports) that includes medical records data from millions of individuals enrolled in 

10 U.S. health care systems (Yih et al., 2011).6 These health care systems’ EHRs enable 

VSD’s large, linked database to be used in research studies to examine the safety of a 

specific vaccine by determining the incidence rate of a specific illness/condition following 

vaccination and comparing it with the rate in patients who did not receive that vaccination 

(National Network for Immunization Information, 2010). Despite the limited number of 

health plans that participate in the VSD, policy makers and immunization stakeholders rely 

on VSD’s capacity to produce rapid-cycle analysis to investigate vaccine safety questions. 

Although lot numbers are already included in VAERS and in VSD (National Network for 

Immunization Information, 2010), barcoded vaccines’ capacity to reduce human error in 

record keeping suggests that data quality may be improved. Such improvements can 

enhance these systems’ capacity to reliably answer vaccine safety questions. 

2.3 Immunization Practice 

Immunization practice requires considerable documentation as part of inventory 

management, vaccine administration, and billing (Figure 2-2). At each point where 

documentation occurs, there is an opportunity for inaccurate reporting (e.g., recording TDaP 

instead of Tdap; HBV instead of HPV, or inaccurate lot number or expiration date). Likewise, 

the need for the same information to be entered into multiple systems not only increases 

the likelihood of error but is also inefficient. In this section of our review, we examine 

literature related to time–motion studies, extraimmunization, vaccine wastage, inventory 

management, and the prevalence of immunization by provider type. 

2.3.1 Time–Motion Studies 

Time–motion studies have been performed since the 1920s to measure efficiency in the 

workplace. In the area of immunization practice, we found five articles reporting on time– 

motion studies in immunization practice (Quach et al., 2011; Glazner et al., 2004; Davis et 

al., 2002, 2004; Washington et al., 2005), although only Quach et al. (2011) considered 

outcomes that are relevant to addressing the impact of barcoded vaccines on provider time. 

Quach et al. (2011) compared data collection systems in Canada during the 2009 H1N1 

influenza pandemic, focusing on differences in the time to complete data collection tasks 

across three types of data collection systems: wholly electronic, hybrid (electronic plus 

6

The following health care systems participate in the VSD: Group Health Cooperative of Puget Sound, 

Seattle, Washington; Harvard Pilgrim Health Care, Boston, Massachusetts; HealthPartners Research 

Foundation, Minneapolis, Minnesota; Kaiser Permanente Northwest, Portland, Oregon; Kaiser 

Permanente Medical Care Program of Northern California, Oakland, California; Kaiser Permanente 

Colorado, Denver, Colorado; Kaiser Permanente of Georgia, Atlanta, GA; Kaiser Permanente of 

Hawaii, Honolulu, Hawaii; Marshfield Clinic Research Foundation, Marshfield, Wisconsin; Southern 

California Kaiser Permanente Health Care Program, Los Angeles, California. 

2-9 
 

Chapter 2 — Literature Review 

Figure 2-2. Common Immunization Administration Process Flow 

Patient 

Record reviewed 

for need for 

immunizations 

Vaccine 

Is it a VFC 

Provider? 

Vaccine is stored 

Yes No 

Is it a VFC 

vaccine? 

Vaccine is stored 

separately from 

VFC vaccines 

Vaccine is stored 

separate from nonVFC vaccines 

Yes Does No

patient need 

vaccination? 

Is 

patient VFCeligible? 

Vaccine prepared 

for administration 

Patient 

Vaccine 

information 

entered in patient 

record 

Vaccine 

administered to 

patient 

Encounter 

information 

entered for billing 

and records 

Charges 

determined and 

sent for payment 

VFC vaccine 

pulled from 

inventory 

Non-VFC vaccine 

pulled from 

inventory 

Yes 

Yes 

No 

Consenting adult 

receives Vaccine 

Information 

Statement (VIS) 

Reconciliation of 

doses billed vs. 

administered 

Source: RTI International based on observation of clinical practice. 

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Chapter 2 — Literature Review 

paper) systems with paper client registration, and hybrid systems with electronic client 

registration. Within each data collection system, provider tasks were characterized as either 

paper based or electronic. Table 2-5 shows each of the defined tasks that Quach et al. 

(2011) tracked, how they differed across paper-based and electronic data collection 

systems, and RTI’s estimate of the impact of vaccine barcoding on the task. 

Table 2-5.	 Comparison of Data Collection Tasks in Paper-Based vs. Electronic 

Systems 

Task Description Paper Example 

Electronic 

Example 

Anticipated 

Impact of 

Barcoded Vaccine 

Client 

registration 

Time to collect and 

record demographic 

information 

Clerk fills out 

demographic 

information for client 

Swipe card or 

prepopulated 

database to obtain 

Not applicable 

(N/A) 

demographic 

information 

Collecting 

medical history 

Time to collect and 

record information 

regarding potential 

contraindications 

Clerk/nurse records 

medical information 

consent form 

Clerk clicks series 

of boxes to record 

medical 

information 

No direct impact 

and previous 

administration of 

seasonal influenza 

vaccine 

Immunization 

record keeping 

Time to record 

information about 

vaccine (vaccine, 

dosage, dose 

number, lot number, 

Nurse writes lot 

numbers on form or 

checks off details if 

prefilled 

Nurse clicks screen 

with prepopulated 

vaccine lot 

information 

One swipe with 

barcode reader 

would allow for 

data capture of 

vaccine lot 

vaccinators’ name, numbers and 

site) expiration date 

Preparing proof 

of vaccination 

documentation 

Time to prepare 

immunization record 

for client 

Nurse fills out card 

for client or provides 

preprinted vaccine 

proof or carbonless 

copy 

Nurse prints 

vaccine proof 

Information on lot 

number and 

expiration date 

could be easily 

included in 

vaccination 

documentation 

Source: Adapted from Quach et al. (2011). 

Quach et al. (2011) found that electronic methods for influenza vaccine record keeping took 

an average of 9.4 seconds per client vaccinated compared with paper-based methods, which 

took 30.1 seconds on average. The time to prepare proof of vaccination documentation was 

an average of 13.4 seconds per client using a paper-based data collection approach and 0 

seconds per client using an electronic approach, because the documentation was 

automatically printed for clients. These findings suggest that vaccine barcoding, in 

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Chapter 2 — Literature Review 

combination with EHRs, is likely to reduce the time spent on immunization data collection by 

approximately 34 seconds per client. 

2.3.2 Vaccine Inventory Management 

Surveys of family physicians and ob-gyns have identified vaccine inventory management (or 

components thereof) as barriers to their immunization practice (Campos-Outcalt, JeffcottPera, Carter-Smith, Schoof, & Young, 2010; Power et al., 2009). Providers who participate 

in the Vaccines for Children (VFC) Program have their own specific requirements for 

inventory management in addition to whatever inventory management activities they are 

already performing (Immunization Services Division, 2007). Barcoded vaccines’ capacity to 

facilitate efficient and accurate record keeping shows promise to facilitate vaccine inventory 

management. As a result, one may anticipate that barcoded vaccines could indirectly 

address one barrier to immunization practice. It is also possible that monitoring usage over 

time would provide the practice with greater insight into its utilization, which in turn may 

improve vaccine ordering procedures and the frequency with which orders are placed. 

In addition, improved vaccine inventory management may reduce vaccine wastage. Vaccine 

wastage occurs when vaccine doses go unused before their expiration date. Setia et al.’s 

study examined wastage due to interruptions of the cold chain (heat or freezing), physical 

damage of package or label, loss in transit or inventory, or incomplete use of all doses in a 

multidose vial (Setia et al., 2002). Although Setia’s data did not specifically examine 

wastage of single-dose vaccine products, one may further assert that wastage may include 

not using a single-dose vaccine before the expiration date. As with extraimmunization, 2Dbarcoded vaccines offer the means to potentially improve record keeping—including vaccine 

management—which could reduce vaccine wastage. 

The incidence of vaccine wastage is poorly documented. Setia et al.’s (2002) article 

continues to be the primary citation on the subject. Although it is presumed that less 

vaccine is wasted in developed nations with more robust immunization systems than in less 

developed nations (in large part due to a more reliable cold chain), the high cost of many 

vaccines recommended for routine administration in developed nations makes even 

relatively low rates of vaccine wastage costly. Setia et al.’s study included a close analysis 

of vaccine wastage in five states. They found wastage variation by vaccine type (hepatitis 

B—1.1%, measles—43.8%) and geographic region in which the five states were located 

(Northwest—1.4%, Southwest—5.4%). The greatest proportion of vaccines wasted was 

2.6% because the vaccine was “spoiled/lost/other.” The smallest proportion of vaccines 

wasted was 0.0002% because the vaccine’s label was “missing.” 

Although Setia et al. do not specifically report what proportion of wasted vaccine doses were 

due to poor vaccine management, their findings combined with our understanding of the 

attributes associated with an optimally implemented electronic data collection system 

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Chapter 2 — Literature Review 

suggest that using barcoded vaccines could reduce at least some vaccine wastage, 

particularly wastage caused by poor vaccine management. For example, barcoded vaccines 

facilitate more precise monitoring of vaccine inventory. By more precisely monitoring 

inventory, immunization providers can more easily ensure that vaccines are used in order of 

their expiration date. Such an approach may reduce vaccine wastage due to expiration prior 

to administration. Likewise, barcoded vaccines facilitate more reliable recording of doses 

administered, thus reducing the waste associated with extraimmunization. 

2.3.3 Immunization by Provider 

Vaccines are administered in a variety of locations by a variety of providers. The reasons 

why this distinction is relevant when considering the impact of 2D-barcoded vaccines 

include the following: 

 Different locations have different infrastructures for data collection and reporting. A 

pediatric practice is likely to have a completely different administrative structure 

than a pharmacy. These differences have implications when considering cost 

estimates as well as when considering the practicalities associated with implementing 

barcode technologies. 

 Providers may practice in a variety of locations. For example, a nurse may provide 

immunizations in a private practice, shopping mall, or pharmacy. This may be 

relevant when designing training programs. For example, one should not assume 

that training simply targeting pharmacy locations will necessarily reach pharmacists. 

 Immunization locations may include a variety of providers. For example, a vaccine 

administered in a pharmacy may be provided by a nurse or a pharmacist. This 

variety has implications when interpreting literature that reports on the location 

where a vaccination was received. 

 Different provider and location types may have different needs for training materials. 

No comprehensive data source reports which health care providers administer what vaccines 

to particular clients. In this review, we present literature that reports on immunizations 

provided by pediatric and adult primary care physicians, including pediatricians, family 

physicians, internal medicine physicians, and ob-gyns. Unfortunately, information on the 

proportion of vaccines administered by health departments is not available. 

Pediatric Practices 

The National Immunization Survey (NIS) categorizes immunization providers into public and 

private. The NIS reports that more than half (60.4%) of childhood immunizations are 

provided by private providers, nearly a quarter are provided by a mixed public/private 

provider, and the remainder (14.2%) at public health departments (Lindley, Shen, 

Orenstein, Rodewald, & Birkhead, 2009). 

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Chapter 2 — Literature Review 

A 1999 study reported that 74% of children in a nationally representative survey received 

all or some of their immunizations from a provider considered to be the child’s medical 

home. For these children, 70% were immunized by pediatricians, 12% by family physicians, 

and 18% by a combination of provider types (Santoli, Rodewald, Maes, Battaglia, & 

Coronado, 1999). 

Family Medicine Practices 

The AAFP surveyed 2,000 of its nearly 25,000 members who had self-identified as spending 

at least 80% or more of their time providing direct patient care. From the 637 eligible 

(office-based) respondents, at least 80% or more reported providing most routinely 

provided child, adolescent, and adult vaccines within their practice (Campos-Outcalt et al., 

2010). Many family physicians also referred patients elsewhere for immunization services 

either in addition to or in lieu of the immunizations provided within their practice setting. 

Referral was more common for adults (53.5%) than for children and adolescents (44.1%). 

Internal Medicine Practices 

A survey of 1,109 adult primary care providers (internal medicine and family physicians) in 

office-based, direct patient care revealed 37 whose practices did not stock any vaccines for 

adults (Freed et al., 2011). Of the remainder who did stock vaccines, a broad range of 

vaccines was stocked. The most commonly stocked vaccine was Td (92%); the least 

commonly stocked was zoster (45%). Two percent of respondents reported plans for their 

practice to cease stocking any vaccine in the coming year, whereas 12% reported plans for 

their practice to increase the variety of vaccines stocked. Reasons for not stocking specific 

vaccines include inadequate reimbursement, inconsistent insurance coverage of patients, 

and high inventory cost. 

Obstetrics-Gynecology Practices 

Ob-gyns are regarded by many women as their primary care provider and their role as an 

immunization provider is evolving. A study by Power et al. (2009) revealed that most obgyns disagreed (40.9%) or strongly disagreed (24.6%) with the statement “routine 

screening for vaccine-preventable diseases falls outside the routine practice of an ob/gyn.” 

A majority (78.7%) of ob-gyns reported stocking at least one vaccine in their practice. 

Pharmacy and Retail-Based Settings 

Pharmacists are a growing provider of immunization services. As mentioned above, some 

data report the number of persons receiving vaccinations at pharmacies, but it is not clear 

whether the pharmacist provided the vaccination. This distinction is relevant when 

estimating the costs associated with different provider types as well as when considering 

approaches to implementing vaccine barcode technologies. A survey conducted by the 

American Pharmacists Association (APhA) (2011) found that licensed pharmacists may 

administer at least one type of vaccine in all 50 states and the District of Columbia. There is 

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Chapter 2 — Literature Review 

considerable variation among states regarding which vaccines can be administered to 

people in various age groups. 

For example, in the District of Columbia, pharmacists are licensed to administer influenza 

vaccine only to people 18 years of age or older. Other states permit administration of 

certain vaccines to people as young as 3 years of age. The paucity of data quantifying 

pharmacists’ contribution to vaccine administration presents a challenge when assessing the 

impact of 2D-barcoded vaccines. Nevertheless, our review of available information suggests 

that pharmacists who provide immunization services in a pharmacy setting are unlike other 

immunization providers. In particular, because most pharmacists do not administer to 

patients younger than 24 months, pharmacists are less likely than most other immunization 

providers to immunize young children (APhA, 2011). 

2.4 Electronic Data Exchange for Immunization 

2.4.1 Electronic Health Records 

A robust electronic data exchange infrastructure is necessary to take the fullest advantage 

of automated identification of vaccine products using 2D barcodes. Although an EHR system 

is not required to use 2D barcodes, analyses presented in later chapters indicate that those 

practices that do use EHRs are more likely to benefits from 2D barcodes. Although studies 

of EHR adoption and use suffer from inconsistencies in terminology and methods, adoption 

is known to be accelerating. 

DesRoches et al. (2008) reported that, as of early 2008, 13% of physicians reported having 

a basic EHR system and 4% reported having a fully functional system. The 2010 National 

Ambulatory Medical Care Survey (NAMCS) revealed that nearly half (50.7%) of office-based 

physician practices have “any” EHR system and only 10.1% have a “fully functional” EHR 

system (Hsiao, Hing, Socey, & Cai, 2010).7 

The Medical Group Management Association (MGMA) found, based on a survey from a 

convenience sample, that 52.3% of respondents reported using an EHR for “health records 

storage” in 2010 (MGMA, 2011).8 This same survey found that the majority of respondents’ 

practices had integrated EHR and practice management systems (PMS): 78.8% of pediatric 

practices, 78.4% of family practice practices, 74.8% of ob-gyn practices, 71.1% of primary 

care multispecialty practices, and 63.8% of internal medicine practices. In 2011, MGMA 

7

According to Hsiao et al. (2010) a fully functional EHR include all functionalities of basic systems plus 

the following: medical history and follow-up, orders for tests, prescription and test orders sent 

electronically, warnings of drug interactions or contraindications, highlighting of out-of-range test 

levels, electronic images returned, and reminders for guideline-based interventions. 8

We interpret the use of an EHR for “health records storage” is a kin to “any” EHR. Thus, our 

interpretation is that the responses are comparable, despite the fact that the NAMCS’s respondents 

were randomly selected and MGMA’s survey used a convenience sample. 

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Chapter 2 — Literature Review 

found more providers with what the NAMCS defines as a fully functional EHR; 16.3% of all 

respondents reported that their implementation of EHR was complete.9 

The Health Information Technology for Economic and Clinical Health Act (HITECH) supports 

the adoption of EHRs. As part of HITECH, the Centers for Medicare & Medicaid Services 

(CMS) will provide cash incentives for Medicare and Medicaid providers who implement EHR 

systems that meet certain requirements for meaningful use (HITECH Act, 2009). HITECH’s 

meaningful-use provision is intended to ensure the quality of data included in EHRs by 

establishing benchmarks against which providers’ use of EHRs is evaluated (Hogan & 

Kissam, 2010). Among the benchmarks against which providers’ meaningful use can be 

assessed is the ability to submit electronic data to immunization information systems (IIS). 

As long as they enroll by 2012, eligible Medicare providers may earn up to $44,000 over 5 

years; eligible Medicaid providers may earn up to $63,750 over 6 years. CMS’s incentives 

are anticipated to have a dramatic impact on health care providers’ adoption of EHRs and, 

by association, the potential adoption of barcoding for data collection. Seventy-two percent 

of respondents from medical practices reported that they planned to participate in the 

HITECH incentive program (MGMA, 2011). 

2.4.2 Immunization Information Systems 

Among the data systems that could be affected by 2D-barcoded vaccines are IIS (formerly 

known as immunization registries). IIS are confidential, population-based, computerized 

information systems for the collection of vaccination data for all residents within a 

geographic area.10 

IIS is recognized by the Guide to Community Preventive Services as a means to support 

immunization programs (Guide to Community Preventive Services, 2011). The most recent 

Immunization Information Systems Annual Report (IISAR) estimated that in 2008 

approximately 75% of children less than 6 years of age (18.4 million) had at least some 

immunization data in an IIS (Morbidity and Mortality Weekly, 2010). Although that number 

was an increase from surveys conducted in prior years, there are still challenges to IIS 

reaping the full benefits that barcoded vaccines promise. 

In 2008, complete lot number information for children under the age of six was part of the 

IIS in 38% of reporting immunization grantees. This compares with 40% for vaccine 

manufacturer data and 98% for vaccine type data. Omitting vaccine lot from the IIS makes 

it impossible to rely on the IIS in the case of vaccine recalls or investigations of vaccine 

safety concerns associated with a specific lot number. 

9

See http://www.cdc.gov/nchs/data/hestat/emr_ehr_09/emr_ehr_09.htm. 10The following data elements are required for IIS: patient name: first, middle, last; patient birth 

date; patient sex; patient race; patient ethnicity; patient birth order; patient birth state/country; 

mother’s name: first, middle, last, maiden; vaccine type; vaccine manufacturer; vaccination date; 

and vaccine lot number. 

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Chapter 2 — Literature Review 

2.5 Limitations 

This availability of literature and related information limits the degree to which we can 

identify the impact of 2D barcoding on vaccines. The complexities of the U.S. immunization 

system mean that seemingly straightforward questions such as “How many doses of vaccine 

are administered by pediatricians?” cannot be answered by available information. Publically 

collected data, like BRFSS, have significant limitations. An additional, fundamental limitation 

is that because 2D-barcoded vaccines do not yet exist, assessing their impact using 

available literature requires inference. Although our inference is based on our understanding 

of the U.S. immunization system and technology assessment, it is not without limitations. 

2.6 Conclusions 

Our review of the literature focused on barcoding in health care, safety issues, immunization 

practice, inventory management, immunization information systems, and electronic data 

exchange. Based on this literature, we anticipate that 2D-barcoded vaccines have the 

potential to impact (directly or indirectly) a variety of aspects related to immunization 

practice. 2D-barcoded vaccines’ capacity to capture vaccine information, most notably lot 

and expiration date, which is free of human error can result in improved record keeping and 

overall data quality. When this information is integrated into a robust EHR, the information 

can be used to support clinician decision making to ensure patients receive the right vaccine 

at the right time. The result of such supported decision making may be reduced rates of 

extraimmunization and vaccine wastage. This, in turn, may reduce costs associated with 

vaccine doses that are unnecessary or wasted. In addition, improving the accuracy and 

completeness of vaccine lot and expiry information in electronic data systems can facilitate 

the inclusion of this information in IIS and enhance the quality of the data included in IIS. 

Furthermore, improvements in collecting and sharing vaccine information can facilitate the 

means to identify and respond to vaccine safety concerns. 

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3. IMPACT ON VACCINE PRODUCTION
 

This chapter presents our analysis of the impact of the transition to 2D barcoding on vaccine 

production. It reviews manufacturers’ knowledge, attitudes, and beliefs; their assessment of 

technical feasibility; and the economic costs of upgrading packaging and labeling lines to 

include online 2D barcode printing technology. At present, linear barcodes appearing on 

product labels are printed off site by third-party vendors and then delivered to production 

facilities. In contrast, to ensure that the correct expiration date and lot number are encoded 

on the label affixed to the primary packaging, 2D barcodes will be printed on the packaging 

and labeling line. 

According to the five of seven manufacturers participating in this analysis, adding online 2D 

barcode printing is technically feasible and will not significantly alter routine production 

operations once implemented. It is a one-time capital expense. Indeed, analysis of data 

provided by manufacturers indicates that the average cost per line will amount to $1.22 

million. Because five manufacturers plan to upgrade 25 lines located in the United States 

and other countries, the total implementation cost is estimated to be $30.60 million 

between 2011 and 2013. One additional firm is considering implementation, while another 

does not plan to upgrade because of the expense of doing so and not because of technical 

infeasibility. 

3.1 Methodology for Assessing Impacts on Vaccine Production 

Impacts on vaccine manufacturers were collected via semistructured interviews with 

manufacturers and tabulated via quantitative analyses of the capital, labor, and materials 

required to upgrade manufacturers’ packaging and labeling lines. In addition to one-time 

implementation costs, ongoing incremental impacts on the costs of production were 

analyzed, which required us to estimate the annual number of doses produced for 

distribution in the United States.1 The estimated production volume also served as a frontier 

against which the volume of immunizations by medical specialties included in the study and 

by local health departments (LHDs) could be compared to ensure that our model did not 

forecast numbers of immunizations that exceed production volumes. 

3.1.1 Primary Data Collection 

Of the 11 manufacturers that have the Food and Drug Administration (FDA)-approved 

vaccine products on the U.S. market (Table 3-1), 7 participated in our study. They produce, 

market, or distribute over 90% of the total number of vaccine products licensed for sale in 

1

In this analysis, we defined dose as a discrete unit of a vaccine product. 

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Chapter 3 — Impact on Vaccine Production 

Table 3-1. Manufacturers that Produce, Market, and/or Distribute Licensed 

Vaccine Products in the United States 

Berna Products Corp. (Crucell) Intercell Novartis 

CSL Biotherapies MassBiologics Pfizer 

Emergent Biosolutions MedImmune Sanofi Pasteur 

GlaxoSmithKline Merck 

Note: As of October 2011. 

the United States.2 Six manufacturers participated in three stages of primary data 

collection: preliminary interviews, site visits, and follow-up interviews.3 One manufacturer 

only participated in a telephone call. Repeated attempts to contact the remaining four 

manufacturers were unsuccessful. 

The purpose of the preliminary interview was to rapidly acquire information regarding the 

firms’ knowledge, attitudes, and beliefs about 2D barcoding; their preliminary assessment of 

feasibility; and any implementation plans they might have.4 The interview also permitted 

manufacturers to ask questions about the study, to review the discussion guide with RTI, 

and to assess the level of effort for participation. Telephone interviews lasted between 30 

and 90 minutes, with the exception of one call that ran for no more than 5 minutes.5 These 

interviews were held between November 2010 and March 2011. 

For the site visits, RTI’s personnel traveled to manufacturer locations for meetings lasting 

between 90 minutes and 4 hours each. Using the discussion guide as a de facto agenda (see 

Appendix B), manufacturers’ representatives took the lead on coordinating the site visits 

and determining the meeting date, location, attendees, and duration in consultation with 

RTI. The site visits, which were held between January and April 2011, yielded details and 

quantitative data that complemented the information gained during telephone interviews. 

2

Note that we emphasize the total number of vaccine products licensed for sale in the United States 

and not the total volume of doses produced for the U.S. market. This distinction is important 

because a manufacturer may have only one or two licensed products but produce a large volume of 

doses. 

3

Because of adverse weather conditions in February 2011 a teleconference was conducted in lieu of 

one site visit. One additional manufacturer was not available for a site visit and preferred a 

teleconference. Lastly, one manufacturer declined to participate in a site visit. 4

Our first preliminary interview was conducted on site by researchers with backgrounds in business 

and finance, as well as public health and immunization policies and programs. This interview was 

used as a pilot to ensure discussion guide questions were appropriately phrased and sequenced and 

to learn about historical American Academy of Pediatrics (AAP), FDA, and manufacturer 

conversations about 2D barcoding. Because of schedule and resource constraints, all other 

preliminary interviews were conducted by telephone. 

5

Some manufacturers included a large number of staff on the introductory telephone call. It was 

quickly determined that it would be most effective and efficient to conduct the bulk of the interview 

in person during the site visit. 

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Chapter 3 — Impact on Vaccine Production 

Manufacturers included representatives from departments such as marketing, immunization 

policy, production management, packaging and labeling operations, logistics, and 

information technology (Table 3-2). Following the telephone interviews and site visits, RTI 

remained in contact with manufacturers to follow up on outstanding questions or request 

clarifications and to ask manufacturers to verify entries for their respective companies made 

by RTI in our benefit-cost model. 

Table 3-2. Interviewed Manufacturer Representatives 

Manufacturer Representative Titlesa Modes of Data Collection 

A Director, Supply Chain Technology; Director, 

Packaging Technology; Senior Packaging Engineers; 

Senior Director, Packaging Operations 

Telephone, site visit, conference 

call, e-mail 

B Senior Director, Marketing; Senior Director, 

Packaging Technology; Director, Packaging 

Technology 

Telephone, site visit, conference 

call, e-mail 

C Senior Director, Marketing; Senior Director, 

Packaging Technology; Consultant; Representative 

from Regulatory Affairs 

Telephone, conference calls, 

e-mail 

D Senior Packaging Engineer; Director, Packaging 

Technology 

Telephone, conference calls, 

e-mail 

E Director, Operations Telephone, e-mail 

F Senior Packaging Engineer; Director, Marketing Telephone, site visit, conference 

call, e-mail 

G Director, Supply Chain Technology; Director, 

Packaging Technology 

Telephone, site visit, conference 

call, e-mail 

a

Titles for manufacturer representatives were harmonized across interview respondents to avoid 

identifying individuals and responding companies. 

Interviews were conducted under confidentiality agreements that specified that only 

aggregated responses would be available in any format outside of the RTI project team, 

including project documentation made available to the Centers for Disease Control and 

Prevention (CDC). Notes were taken during all meetings. Some meetings were also audiorecorded, when the manufacturer approved, to help resolve discrepancies should alternative 

interpretations of a manufacturer’s response exist in an interviewer’s notes when compared 

across the team. RTI’s institutional review board (IRB) determined that manufacturer data 

collection protocols were exempt from IRB requirements. CDC was not engaged. 

3.1.2 Estimation of One-Time Fixed and Ongoing Variable Costs 

Manufacturers were asked to provide actual or forecasted data on their capital equipment, 

labor, and materials requirements, either in dollar terms or in physical units that RTI could 

later monetize through discussions with vendors and compare with other manufacturers’ 

estimates for similar packaging and labeling lines. Cost estimates were also compared with 

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Chapter 3 — Impact on Vaccine Production 

a benefit-cost study prepared by HDR, Inc. for the Canadian Automated Identification of 

Vaccine Products Advisory Task Group (HDR, 2009). 

Any one-time costs were expected to fall into the following categories: capital equipment 

(e.g., printers, vision systems, and associated tooling); project management, 

implementation, and trials; changes in standard operating protocols; software and interface 

programming and testing; training and certification; label redesign; and regulatory reviews 

and submissions to the FDA. Manufacturers were given the option to discuss other 

categories if the costs were material to the entire project value. 

Any recurring costs were expected to fall into the following categories: labor; label media; 

periodic interface programming and line testing; consumables, such as inks or other inputs; 

quality control and assurance; fees associated with membership in standards groups (such 

as GS1, if they were not already members); and annual software licensing costs.6 

In addition to cost estimates, operational and production data were provided by 

manufacturers to allow RTI to aggregate responses across manufacturers to form industrylevel impact estimates. Manufacturers provided data on their global packaging and labeling 

lines, product portfolio, production volume for the U.S. market, label media, and primary 

packaging. 

3.1.3 Estimation of Doses Distributed in the United States, 2013 to 2023 

The number of doses for the U.S. vaccine market for 2013 to 2023 was estimated by 

reviewing production data provided by manufacturers, CDC, the Advisory Committee on 

Immunization Practices (ACIP)-recommended schedule as of February 2011 (CDC, 2011b), 

and current immunization rates and scaling to U.S. population estimates by single year of 

age (U.S. Census, 2005, 2009), assuming immunization and series completion rates remain 

constant over time.7 Market data on the number of doses for 2010 were provided by CDC 

(flu products only; Kennedy, 2011) and vaccine manufacturers (all products). The quantity 

demanded of flu products was assumed to be proportional to the projected U.S. population, 

and the ratio of nonflu doses to persons for 2013 to 2023 was assumed to be equal to that 

for 2010. 

The quantity demanded for nonflu products was estimated in a two-step process. In the first 

step, immunization rates for vaccines on the ACIP-recommended immunization schedule as 

of January 2011 were multiplied by annual population estimates by single year of age for 

the 30-year period ending in 2030. The source for immunization rates was the 2009 

6

Manufacturers were given the option to discuss other categories if the costs were material to the 

entire project value. However, no additional cost categories were identified. 7

Dose estimation was necessary to estimate the incremental impacts associated with changes in label 

media and to form a frontier in the analysis against which to check project immunization volume 

conducted by provider groups included in the quantitative analysis. 

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Chapter 3 — Impact on Vaccine Production 

National Immunization Survey (CDC, 2010), which includes data on series completion, and 

the source for the population by single year of age data was the U.S. Census Bureau (2005, 

2009). To account for wastage and extraimmunization, dose estimates were inflated by 

wastage and extraimmunization rates from the literature. Yet our literature review revealed 

that actual rates for wastage and extraimmunization are ill defined.8 Therefore, the results 

of this first step became an index of the ratio of pediatric/adolescent and adult vaccines to 

total nonflu production volumes. 

In the second step, the total production volume for each year beginning in 2013 was 

assumed to be proportional to the projected U.S. population, with actual data for 2010 

serving as the reference year. Flu doses were subtracted from total doses, and then the 

index created as part of Step 1 was used to segment the balance into pediatric and adult 

doses. The results of these calculations were then rounded to the nearest 100,000 doses to 

account for measurement error. See Appendix C for additional detail on forecasting the 

number of doses for the U.S. market. 

3.1.4 Assumptions 

The model of manufacturers’ costs and benefits makes the following assumptions: 

 All dollar values are in 2010 dollars and the unit-level costs are held constant over 

time. In other words, real (“inflation-adjusted”) costs do not change. 

 No new vaccine products or new product container types are introduced, and there is 

no change in the relative proportion of individual products across prefilled syringes, 

single-dose vials, multidose vials, or other container types. 

 No changes to label media, apart from peel-off to flat labels, are introduced. 

 Vaccine manufacturers’ market shares within each product segment remain constant. 

 Immunization and series completion rates are constant. In other words, there is no 

change in immunization rates in the United States over the time period of analysis, 

only in the population overall and by the population by single year of age. There are 

also no changes in ACIP-recommended schedules. 

 2D barcodes appear on all vaccine product labels beginning January 1, 2013. 

8

Setia et al.’s 2002 study of wastage showed variation by vaccine type (hep B—1.1%; measles— 

43.8%) and geographic region in which the five states were located (Northwest 1.4%; Southwest 

5.4%) (Setia et al., 2002). Feikema and colleagues (2000) examined extraimmunization of 

hepatitis B, DTP/DTaP, Hib, polio, and measles vaccines and found a range of weighted percentage 

by vaccine of 14.1% for polio to 2.5% for measles. Strine and colleagues (2002) recognized that 

the rate of extraimmunization is decreasing (from an estimated 1.8 million extra doses in 1997 to 

775K in 2000) but assert the financial magnitude remains a concern. 

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Chapter 3 — Impact on Vaccine Production 

3.2 Qualitative Manufacturer Interview Findings 

Of the seven manufacturers interviewed, five reported that they had plans to implement 2D 

barcoding of Global Trade Item Number (GTIN), expiration date, and lot number data; one 

reported that they were undecided; and one reported that they do not plan to implement 2D 

barcoding at this time. The time required to implement barcoding was estimated to be at 

least 12 months but no more than 24 months and depended on such factors as number of 

packaging and labeling lines, capital budgeting and procurement procedures, and scheduled 

production downtime. 

3.2.1 Perceptions of Benefits of 2D Barcodes 

Five of seven manufacturers interviewed believe that a 2D barcode on vaccine product 

labels appearing on primary packaging will enhance vaccine safety while simultaneously 

offering efficiency benefits for providers’ immunization businesses. During interviews, some 

manufacturers observed that, although they are part of pharmaceutical businesses, vaccine 

divisions within these businesses have a strong public health focus and see the 2D barcode 

as an advantageous public health opportunity. 

One industry veteran cited the Vaccine Identification Standards Initiative (VISI), noting that 

technologies for providers (vaccine end users) were not sufficiently mature or available at 

low enough cost at the time, causing that effort to stall. In contrast, manufacturers pointed 

to a confluence of factors in the current environment: 

 Leadership: AAP is leading the initiative, coordinating with GS1 to providing guidance 

to manufacturers on using GS1 data matrix standards.9 

 Familiarity with Technology: There is greater familiarity with health care 

technologies, and there are broad shifts toward achieving greater efficiency through 

them. 

 Federal Legislation Supporting Electronic Health Record (EHR) Adoption: Providers 

are adopting EHRs at a greater pace because of incentives and support to adopt 

EHRs funded through the American Recovery and Reinvestment Act (ARRA) and the 

HITECH Act. 

 Market Demand: Vaccine purchasers, especially large ones like Cook Children’s 

Health Care System, are requesting barcodes on vaccines that include product and 

expiration date and that will allow them to improve vaccine supply management. 

2D barcoding may decrease the administrative burden associated with vaccination. It is 

anticipated that reducing time spent on documentation could increase the number of 

9

Manufacturers have complied with the FDA’s linear barcode requirement since 2004 for new products 

and since 2006 for existing products. All vaccine product labels currently contain a linear code. The 

extent to which providers (vaccine end users) use these barcodes is unknown. Accordingly, our 

provider survey included questions to ascertain whether the transition to a data matrix may have 

unintended negative consequences for providers using the linear barcode. 

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Chapter 3 — Impact on Vaccine Production 

providers administering immunizations. Although average rates for pediatric immunization 

coverage are good, there are “pockets of low rates ... that must be reached,” according to 

one interviewee. If logistical barriers to immunization are lowered, then vaccination rates 

could improve. 

Automating vaccine inventory management and record keeping may lower the cost of 

immunization practice and encourage providers who are reluctant to immunize to continue 

or perhaps broaden their immunization practice. One manufacturer representative indicated 

that he believes vaccines may be the second or third greatest expense for pediatric 

practices after payroll. 

Other possible advantages to providers and the immunization system cited by 

manufacturers include: 

 more efficient vaccine administration with fewer record-keeping steps; 

 automated record keeping that populates patients’ EHRs, adjusts inventory and 

ordering systems, interfaces with billing and practice management systems, and 

sends data to IIS; 

 lower vaccine wastage and improved inventory management; and 

 lower reimmunization through improved record keeping in registries. 

Although increased immunization rates would result in increased demand, better data 

capture and population coverage in registries could reduce the amount of reimmunization 

and offset any sales gains. Any discussion of effects on product sales is purely theoretical 

because the net effects are indeterminate. 

3.2.2	 Perceptions of AAP 2D Barcoding Initiative and Use of GS1 

Standards 

Manufacturers expressed support for AAP and believe that AAP is the appropriate “unifying 

organization” and advocate for the 2D barcoding initiative at the FDA.10 They also viewed 

GS1 as the appropriate standards organization because GS1 product identification standards 

are used globally, and they are already familiar with the organization and its procedures. 

Implementation of 2D barcoding requires universal, or near universal, adoption by 

manufacturers to be effective. It is a standards issue, and manufacturers must align to a 

common format. Thus, a unifying organization is needed to facilitate standards adoption 

across organizations. Interviewees indicated that this feasibility and economics study is an 

important contribution to filling the data gaps and will ultimately produce an objective and 

10In response to questions about BIO and its involvement in the barcoding initiative, one manufacturer 

noted that “BIO has enough on its plate.” His view was that there are only 9 or 10 vaccine 

manufacturers (with unique interests) compared with hundreds of biologics firms, and that through 

the unifying forum of AAP/GS1, a consensus industry standard can be reached. 

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Chapter 3 — Impact on Vaccine Production 

independent assessment of costs, benefits, and technical requirements. They would like this 

final report to be a publicly available document. 

In December 2011, the 2D barcode standard and barcode data fields for vaccine product 

labels were determined: a GS1 data matrix containing the GTIN (which includes the National 

Drug Code [NDC]), expiration date in YYMMDD format, and lot number. If acceptable to the 

FDA, and if the FDA grants a waiver to a manufacturer(s), this 2D barcode will appear on 

primary packaging. The inclusion of different data elements in the 2D barcode was largely 

precluded by the availability of sufficient area (“real estate”) on the label for an enlarged 

data matrix. Some manufacturers may include a 2D barcode on the secondary packaging to 

assist with inventory management. 

3.2.3 Perceptions of Outstanding Questions for the FDA 

During interviews, manufacturers indicated that additional guidance from the FDA on the 

following questions would be useful: 

 What is the exact procedure for requesting the linear barcode waiver, and what 

documentation or validation data are required as part of the waiver request? 

 Is it permissible to place a 2D barcode on the product label appearing on the primary 

packaging to replace the linear barcode, or must both the linear and 2D barcodes 

appear on that label? 

 Do product labels need to be reapproved by the FDA if the linear barcode is removed 

and the data matrix placed on the product label in its place? 

 Is the change in the labeling and packaging line an annual reportable change, or is it 

a CBE-30, under which manufacturers notify the FDA, wait 30 days, and then 

implement the change? 

Multiple manufacturers have projects at some stage of implementation, while others have 

waited for more concrete guidance from the FDA. As long as ambiguities remain, for some 

manufacturers, capital budgeting, implementation plans, and, ultimately, equipment vendor 

selection and implementation schedules may not be finalized. 

3.2.4 One-Time Implementation Costs 

Manufacturers currently outsource production and printing of their product labels, with 

labels arriving at plants on spools fully printed except for the final human-readable 

expiration date and lot number information. These last two items are printed on the label in 

a production step that coincides with affixing the label to the product container (“online 

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Chapter 3 — Impact on Vaccine Production 

printing”). If the label has a linear barcode, it is printed by a vendor offline because the NDC 

data encoded in linear barcodes are static and do not vary by expiration date or lot.11 

In 2D barcoding, however, the symbology contains the static NDC data and the variable 

expiration date and lot number, essentially precluding the option of having the symbol 

printed off site by third-party vendors. Having the symbol printed off site would present 

significant coordination and inventory management challenges, as well as operational and 

regulatory risks. Therefore, under 2D barcoding, manufacturers will have vendors produce 

the label but print the data matrix and human-readable elements online at their location. 

The dot matrix or inkjet printing technology manufacturers currently use for printing 

expiration dates and lot numbers prints at a quality that allows humans to read 

alphanumeric characters but is not capable of printing 2D barcodes of the quality required 

for machines to read data matrices, given the label’s space constraints (ISO/IEC, 2004). 

Therefore, manufacturers that implement 2D barcoding will need to procure and integrate 

appropriate printing and vision systems into their lines. 

Manufacturers’ one-time implementation costs will vary because they depend on the 

 number of packaging and labeling lines for vaccines; 

 primary packaging types (e.g., prefilled syringes, single-dose vials, multidose vials); 

 label materials (e.g., paper or plastic, coatings); 

 overall state, age, and flexibility of tooling; 

 facility footprints and regional manufacturing strategy and legacy operations; 

 planned shutdowns and project scheduling; and 

 their manufacturing flexibility, generally.12 

Capital requirements will include such items as online printers, imaging and image 

verification technology (often referred to as a vision system), and accompanying tooling and 

information systems. Labor requirements will be, at a minimum, resources from regulatory 

affairs, marketing, information technology, packaging and labeling operations, and logistics. 

Implementation timelines are expected to be 12 to 24 months, and we expect that 2D 

barcodes will begin to appear on product labels in calendar years 2012 and 2013. 

11Some vaccine products labels affixed to primary packaging do not include linear barcodes because 

the manufacturers received a waiver from the FDA in recognition of the containers’ physical 

characteristics, such as curvature and size. In such cases, the linear barcode often appears on 

blister packs or other packaging. 

12For example, if a manufacturer with 16 products has only four packaging and labeling lines at four 

facilities, their costs could be in the same range as another manufacturer with only four products 

but with each of those products produced at different facilities. 

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Chapter 3 — Impact on Vaccine Production 

Selection of printing technology depends on the type of packaging (e.g., prefilled syringe, 

single-dose vial, multidose vial) and the label medium used. For flat labels on single dose 

and multidose vials, online printing will likely be accomplished using high-quality inkjet 

technology. Inkjet technology is currently used to print human-readable expiration date and 

lot number information on product labels. However, the quality levels are unacceptable for a 

machine-readable 2D barcode. The code would be too blurry; thus, new capital equipment 

will be required. For prefilled syringes, which often have plastic labels, online printing using 

laser technology will likely be used. 

Other costs to be considered are label redesign and regulatory submission, inventory 

carrying costs, and international transactions costs. There may also be costs for redesigning 

the primary packaging labels to remove the linear barcode and include the data matrix 

barcode, to submit the changes to the FDA, and to manage the FDA regulatory submission. 

It is also possible that a manufacturer may be able to add the 2D barcode without removing 

a linear barcode, if sufficient label space is made available. 

Line upgrades would be integrated into site-level plans to occur during planned facility 

shutdowns. Planned shutdowns occur at regular intervals for maintenance, inspections, and 

implementation of other projects. During these shutdowns, equipment will be installed, 

processes reengineered as necessary, and a series of line trials will be conducted to validate 

the online printing system. To meet demand, it is common for facilities to ramp up 

production prior to shutdowns, building to inventory, and then fulfilling orders from this 

inventory. Thus, inventory carrying costs spike before and during shutdowns before 

returning to normal levels. However, if implementation were to occur during planned 

shutdowns, as expected, building to inventory would take place anyway, and higher 

inventory carrying and shutdown costs are not directly traceable to the project. The only 

exception would be if the project extends the shutdown beyond what had been planned. 

Lastly, some manufacturers have vaccine products administered in the United States that 

are produced, packaged, and labeled at facilities outside the United States. For example, 

Novartis Vaccines manufactures its products for the U.S. market in Germany, Scotland, 

Italy, and England; GSK in the United States and Belgium; and Sanofi Pasteur in the United 

States and Canada. The international dimension may add some additional complexity in 

terms of coordination, but the extent to which this is the case is unknown. Most facilities 

producing for multiple national markets do product runs by country because of the variation 

in labeling requirements, including language, barcode size and placement, and required 

human-readable elements. Because manufacturers produce vaccines for multiple markets, 

they are interested in general harmonization. There may be some opportunities to spread 

capital expenditures over larger production volumes than expected because of various 

automated identification regulations being implemented in Canada and other countries. 

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Chapter 3 — Impact on Vaccine Production 

3.2.5 Effect of Implementation on Production Rates 

Representatives from packaging and labeling operations are most concerned about the 

effect of online printing on production rates, barcode image quality, and the ability to 

conduct online imaging to ensure the barcode meets quality standards under Good 

Manufacturing Practices. 

Many upstream and downstream processes are tied to the production rate. Major changes to 

this rate would be disruptive to any given firm’s manufacturing strategy and would affect 

processes as diverse as order management and logistics (e.g., inventory management, 

shipping). In addition, it could affect supply chain operations for distributors and, ultimately, 

customers. 

Packaging and labeling lines often operate at speeds of 400 to 1,000 units per minute, and 

manufacturers will need to optimize printing, imaging, and image verification so that online 

printing and verification do not change the overall rate of production. For some 

manufacturers this is likely going to entail including two printers on one line.13 No 

manufacturer implementing 2D barcoding expects their production rate to change 

significantly. 

3.2.6 Effect of Implementation on Variable Costs 

From the manufacturers’ perspective, most ongoing variable costs are not likely to be 

appreciably different between the current practice of including linear barcodes and the 

proposed future practice of including the data matrix barcodes. Two exceptions vary by 

manufacturer: choice of label media and reject rates. 

Some vaccine product containers have peel-off labels, which are more costly than flat labels 

and are incompatible with online printing. Peel-off labels are produced by vendors using a 

process that involves separately printing and then assembling the two layers of the label. 

Manufacturers that currently offer peel-off labels will discontinue them under 2D barcoding 

because of the technical challenge of printing the 2D barcode on both parts of the label 

online. For some manufacturers, flat labels may be 1.5 to 2 cents to as much as 19 cents 

13The average cost per line presented in this report reflects the fact that some lines will require more 

than one printer. 

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Chapter 3 — Impact on Vaccine Production 

less expensive per dose relative to the peel-off label, depending on the label and the 

container. Others see no material difference.14 

It also is possible that manufacturers could see some increase in their reject rate—the rate 

of rejected units to the total number of units produced—because of poor 2D barcode 

legibility. Although not anticipated by manufacturers, there is the possibility that some 

barcodes would not be printed to a sufficient quality standard. If a unit exits the labeler, has 

its barcode imaged and verified, and is found to have a barcode failing quality standards, 

the unit could be ejected from the line. Ejection is often performed by air puffs, and the 

glass containers are compromised once they land in the reject bin. The unit becomes 

nonsaleable. During one interview, a senior packaging director indicated that a pilot 

conducted on site did not reveal any changes in its reject rate. We expect that any changes 

in reject rates would be a function of ultimate line configuration, container type, and 

process design. 

3.2.7	 Small Lot Sizes 

In contrast to vaccines that may be produced in multiple lots per year, vaccines that are 

produced in small quantities, for example at a rate of one lot per year, may be able to have 

their labels printed with a 2D barcode offline by a vendor. In such cases it may not be costeffective to implement online printing. This may be applicable for a traveler’s vaccine, for 

example. 

3.3	 Benefit-Cost Analysis of Implementation on Vaccine 

Production 

3.3.1	 One-Time Implementation Costs 

One-time implementation costs for 25 vaccine packaging and labeling lines are estimated to 

be $30.6 million and average $1.22 million per line (see Table 3-3).15 Estimated costs are 

14One manufacturer hypothesized that manufacturers could see net cost savings through operation 

efficiencies related to product labels, but he was quick to add that the company has yet to perform 

the calculations to determine if they would indeed recoup capital investments. It is possible that if 

the incremental ongoing variable costs of printing the data matrix barcode (relative to printing the 

linear barcode) are less than the cost savings from using flat labels instead of peel-off labels and 

any increases in the reject rate, then—ignoring the application of a discount rate or hurdle rate— 

the manufacturer could recoup its capital investment over time. The discount or hurdle rate is 

equivalent to a minimum rate of return required for a project to be considered an appropriate use 

of scarce capital funds. This rate varies by firm and is set by a firm’s finance department based on 

their overall cost of capital and their capital project portfolio standards. Conversely, a manufacturer 

would have a disincentive to invest in this project if it faced a capital outlay and incremental costs 

that exceed all other variable cost savings. Although a disincentive may exist, the manufacturer 

may still implement the project. This would likely be true if the manufacturer has insufficient 

market share and its competitors implement the project, if the project is mandated by regulation 

(and the alternative would be to exit the market), or if vaccine purchasers and end users expect 

the label to include a data matrix barcode. The latter is one avenue through which public 

purchasers like CDC or the Department of Defense (DoD), for example, could use their purchasing 

power to affect producer behavior. 

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Chapter 3 — Impact on Vaccine Production 

Table 3-3. Parameter Estimates for Economic Model of Vaccine Production 

Parameter Value 

Number of manufacturers included in the model 7 of 11 firms 

Number of packaging and labeling lines to be converted 25 lines 

Located in the United States 15 lines 

Located outside the United States 10 lines 

Average implementation cost per packaging and labeling line $1.22 million 

Capital budget component 25–40% 

Labor budget component 60–75% 

Total implementation costs $30.6 million 

Implementation time 12–24 months 

Time frame of code appearance 2012–2013 

Number of doses produced for the U.S. market (2010) 336.8 million 

Number of flu doses 163.0 million 

Number of nonflu doses 173.8 million 

Number of containers for which peel-off labels will be eliminated (2010) 83.9 million 

Weighted average savings per dose from elimination of peel-off labelsa $0.057 per dose 

a

Cost savings from eliminating peel-off labels were weighted by volume of syringes and single-dose 

vials. 

almost exclusively capital expenditures (25 to 40%) and project labor (60 to 75%). Fifteen 

lines are located at U.S. production facilities, and 10 lines are located outside of the United 

States. In addition to these 25 lines, 2 lines have already been upgraded; however, the 

costs associated with that upgrade are considered sunk costs because they were incurred as 

part of another initiative. Thus, based on manufacturers’ statements, we expect that as 

many as 27 lines will have 2D barcoding functionality by the end of 2014.16 

Manufacturers expect that upgrades will take between 12 and 24 months. The variation is 

due to the number of lines to be converted, the printing technologies required, and the 

number of printers to be installed per line. Precise schedules vary by manufacturer, and 

each considers its timing to be confidential business information. However, collectively, 

manufacturers estimate that the 2D barcode will begin to appear on product labels in late 

2012 to mid-2013. It is possible that some manufacturers may have 2D barcodes appearing 

on labels earlier. It is also possible that some manufacturers may upgrade later than 

modeled. 

15All dollar values are in real terms (2010).

16If all manufacturers were implementing online printing, at least an additional six lines would be 

converted at a cost of $7 million, bringing the total cost to $37.6 million. However, some 

manufacturers with small-volume products may have the alternative of printing 2D barcodes 

offline. 

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Chapter 3 — Impact on Vaccine Production 

Based on manufacturers’ best available forecasts, the model distributes costs from 2011 

through 2013, allocated at 25% (2011), 50% (2012), and 25% (2013). The majority of 

capital purchases and upgrades are expected to occur in late 2011 or 2012. For the 

purposes of this analysis, although some products may have 2D barcodes appearing earlier, 

we assume that 2D barcodes first appear in 2013 and are available on all vaccine products 

on a full-year basis in 2014. 

3.3.2 Ongoing Variable Costs 

Most manufacturers expect negligible incremental printing or other costs that would be over 

and above current expense levels. However, elimination of peel-off labels will have some 

ongoing cost savings for the industry. To quantify these benefits, for any given year, the 

ratio of the total number of containers from which peel-off labels will be eliminated to the 

total number of doses was multiplied by the expected savings per dose and the estimated 

number of doses.17 The ratio of containers to doses and the expected cost savings in 2010 

were assumed to be representative of future years. The ratio of containers to doses for 

2010 was 0.2492 (83.9 million containers/336.8 million doses), and the expected cost 

savings from eliminating peel-offs from syringes and single-dose vials is expected to be 

$0.057 per dose. (See also notable assumptions list.) 

Table 3-4 presents our dose forecast for all vaccine products except travelers’ and defense 

products.18 For 2015, for example, we forecast 353.40 million doses and estimate that in 

the absence of 2D barcoding, 88.05 million containers (353.40 million doses x 0.2492 

containers/dose) would have peel-off labels. Elimination of these peel-off labels from all 

nontravelers and nondefense products saves $4.99 million (88.05 million x $0.057).19 This 

benefit is added to the time series of manufacturer costs and benefits presented in 

Table 3-5. 

17Some products have two containers: one for the antigen and one for the diluents.

18 Immunization rates for travelers and the DoD are not included in the NIS; thus, we were unable to 

assemble an accurate independent forecast for these products within the schedule constraints of 

this analysis. These products include anthrax, Japanese encephalitis, rabies, smallpox, typhoid, and 

yellow fever. 

19According to AAP minutes (AAP, 2009): While those who still use paper charts, especially in public 

health, may find peel-off labels useful, records are moving into the electronic domain. As that trend 

continues, peel-off labels will become less useful. If it prevents manufacturers from implementing 

barcoding, they are not needed. 

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Chapter 3 — Impact on Vaccine Production 

Table 3-4. U.S. Vaccine Market Forecast, Excluding Travelers’ and Defense 

Products (Doses) 

Dose Forecast 

Pediatric/ 

Adolescent 

Products 

(million units) 

Total, Excluding 

Travelers’ and 

Defense Products 

(million units) 

Projected U.S. 

Population 

(millions) 

Influenza 

Products 

(million units) 

Adult 

Products 

Year (million units) 

2013 319.33 167.80 155.80 23.20 346.70 

2014 322.42 169.40 157.00 23.60 350.00 

2015 325.54 171.00 158.20 24.10 353.40 

2016 328.68 172.70 159.50 24.60 356.80 

2017 331.83 174.30 160.80 25.10 360.30 

2018 335.01 176.00 162.00 25.70 363.70 

2019 338.19 177.70 163.20 26.30 367.20 

2020 341.39 179.40 164.40 26.90 370.60 

2021 344.59 181.10 165.60 27.50 374.10 

2022 347.80 182.70 166.80 28.10 377.60 

2023 351.02 184.40 168.00 28.70 381.10 

Sources: RTI estimates based on U.S. Census Population data (U.S. Census Bureau, 2005, 2009), the 

2009 National Immunization Survey (CDC, 2010), the ACIP Recommended Immunization schedule 

as of March 2011 (CDC, 2011b), and information provided by vaccine manufacturers on production 

volumes. Excluded travelers and defense products were for anthrax, Japanese encephalitis, rabies, 

smallpox, typhoid, and yellow fever. 

3.3.3 Summary Benefit-Cost Analysis Results 

Table 3-5 presents the time series of costs and benefits estimated for manufacturers. Onetime costs of $30.60 million accrue between 2011 and 2013. The only incremental costs or 

benefits estimated pertain to eliminating peel-off labels from syringes and vials. These cost 

savings are estimated to accrue beginning in 2013, assuming that manufacturers complete 

barcode inclusion by the close of that year, and accrue through the end of the period of 

analysis of 2023. These incremental benefits are expected to total $54.08 million over this 

period, offsetting one-time costs to yield net benefits of $23.48 million. 

The net present value (NPV) of expected manufacturer costs and benefits is $5.02 million 

when the Office of Management and Budget (OMB)-specified 7% real social discount rate is 

applied (OMB, 1992).20 At a real discount rate set to 10%, which is closer to the 

biopharmaceutical industry real working average cost of capital (Harrington & Miller, 2010), 

the NPV is $0.17 million. A rate of 10.12% sets the NPV to zero, confirming our interview 

findings that manufacturers view the 2D barcoding initiative as a one-time cost. 

20The NPV is the present value of actual or expected future benefits and costs for an investment 

project, given a discount rate. The discount rate sets a minimum rate of return required by the 

investor. 

3-15 
 

2011 7.65 −7.65 

2012 15.30 −15.30 

2013 346.70 43.19 2.45 7.65 −5.20 

2014 350.00 87.21 4.94 4.94 

2015 353.40 88.05 4.99 4.99 

2016 356.80 88.90 5.04 5.04 

2017 360.30 89.77 5.09 5.09 

2018 363.70 90.62 5.14 5.14 

2019 367.20 91.49 5.19 5.19 

2020 370.60 92.34 5.24 5.24 

2021 374.10 93.21 5.29 5.29 

2022 377.60 94.08 5.33 5.33 

2023 381.10 94.96 5.38 5.38 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chapter 3 — Impact on Vaccine Production 

Table 3-5. Time Series of Costs and Benefits for Vaccine Manufacturers 

Total Doses, 

Excluding 

Travelers’ and 

Defense Products 

(millions) 

Economic 

Benefits from 

Eliminating PeelOff Labels 

($ millions) 

Estimated 

One-Time 

Implementation 

Costs 

($ millions) 

Containers 

without PeelOff Labels 

(millions) 

Net Benefits 

Year ($ millions) 

Total 54.08 30.60 23.48 

NPV @ 7% 5.02 

NPV @10% 0.17 

NPV = Net present value. NPV using the10% real working average cost of capital rate for the 

biopharamaceutical industry is presented for informational purposes only in this table. 

3.4 Conclusions 

Based on participating manufacturers’ collective feasibility assessments, the technology is 

available to enable rapid printing, imaging, and image verification of 2D barcodes, and 

manufacturers will be able to optimize the printing process. The fact that no manufacturer 

objected to 2D barcoding as technically infeasible suggests that this is an engineering 

exercise and one-time expense rather than a cross-cutting change in production. Our 

supposition is that internally manufacturers view the adoption of 2D barcoding first as a 

technology solution for enhancing vaccine product safety through automated identification, 

second as an investment in improving customer satisfaction by enabling providers to 

economize on immunization documentation, and third to enhance the market’s perception of 

their firm as a leader in using technology solutions in the public health arena. 

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4. KNOWLEDGE, ATTITUDES, AND BELIEFS 

OF PRIMARY CARE PROVIDERS AND LOCAL HEALTH 

OFFICIALS 

This chapter reviews responses of primary care providers and local health officials regarding 

knowledge, attitudes, and beliefs related to immunization practice and the potential impact 

of implementing 2D vaccine barcode technologies in primary care practices and local health 

departments (LHDs). These findings are based on interviews with relevant stakeholders and 

a national survey fielded in the spring of 2011. 

There were three objectives for primary data collection. First, we needed to assess 

perceptions of benefits, costs, and technical assistance needs. For example, what do 

immunizers think about using barcodes? What support may they need? Given what we know 

about expected adoption costs, would providers purchase scanners and incorporate their 

usage into their immunization practice? Second, we needed to understand what IT 

infrastructure was in place in primary care practices and LHDs, how their infrastructures 

vary by type and by size of practice (measured by number of physicians), and how it is 

changing. Third, in order to develop national estimates of the economic costs and benefits 

for providers for using the 2D barcode, we needed data on the number of doses 

administered, job positions engaged in immunization, and other cost and benefit variables. 

4.1	 Interview Data Collection with Immunization Provider 

Associations and Primary Care Physicians 

Interview guides were developed based on our previous research experience in 

immunization practice, our review of the literature, early discussions with professional 

associations, and consultation with the Centers for Disease Control and Prevention’s (CDC’s) 

technical monitors.1 

4.1.1	 Vaccine End-User Definitions 

RTI worked with CDC to clarify the end users to be included in assessing end users’ 

knowledge, attitudes, and beliefs. End users include traditional and complementary 

immunization providers. Within this report, the term “traditional” immunization providers 

refers to primary care physicians (pediatricians, family physicians, internal medicine 

physicians, and obstetric-gynecology [ob-gyn]); the term “complementary” immunization 

providers refers to all other immunization providers, such as pharmacists, retail-based 

clinics (RBCs), and visiting nurses. 

1

All interview guides and surveys were submitted to RTI’s institutional review board (IRB). The IRB 

provided this project with an exemption under the determination that it was program evaluation. 

4-1 
 

 

 

 

 

 

 

 

 

 

Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

4.1.2 Traditional Immunization Providers 

To represent primary care physicians, we identified key informants representing 

pediatricians (AAP), internal medicine physicians (American College of Physicians [ACP]), 

ob-gyns (American College of Obstetrician Gynecologists [ACOG]), family physicians 

(American Academy of Family Physicians [AAFP]), and the American Medical Association 

(AMA). Key informants were identified based on RTI’s prior work with these organizations. 

See Table 4-1 for high-level, summary remarks. 

Table 4-1.	 Summary of Anticipated Barriers and Facilitators to Adopting 2D 

Barcoded Vaccines by Provider Group 

Provider 

Anticipated Barriers to 

Adopting 2D Vaccine 

Barcoding 

Anticipated Facilitators 

to Adopting 2D Vaccine 

Barcoding Comments 

Primary care 

practices 

(AAP, AAFP, 

ACOG, ACP, 

AMA) 

Not all practices use 

electronic health record 

(EHR) systems, particularly 

smaller practices. 

Not all EHR systems have 

fields for vaccine lot 

number and expiration 

date. 

Cost of purchasing barcode 

readers. 

EHRs are not required to 

use 2D barcodes. 

2D barcodes are consistent 

with recent trends in 

increasing technology use 

in care delivery. 

Barcoding vaccines is 

regarded as a tool for 

quality assurance. 

Pediatricians are among 

those who are anticipated 

to be affected by the 

Health Information 

Technology for Economic 

and Clinical Health 

(HITECH) Act and to adopt 

EHR systems. 

Pediatricians administer the 

majority of pediatric 

vaccines. 

AAP strongly supports 

vaccine barcoding. 

Family physicians are, 

along with pediatricians, 

more likely than other 

primary care providers to 

participate in the VFC 

Program. 

Pediatricians are receptive 

to means to reduce the 

“hassles” associated with 

vaccination documentation. 

Some internal medicine 

physicians use peel-off 

labels to record expiration 

date and lot in patient 

records. Eliminating peeloff labels may require some 

internal medicine practices 

to change office 

procedures. 

Scanners are expected to 

be installed at nurses’ 

stations and laboratories or 

immunization rooms 

Pharmacists 

(in a 

communitybased 

pharmacy) 

APhA 

Considerable variability in 

scope of practice, ability to 

charge for administration, 

and limited (no) access to 

immunization information 

systems (IIS) in most 

states. 

Some pharmacies are 

already using barcoding for 

pharmaceutical products. 

Most (~90%) pharmacies 

are “computerized” and 

already doing some form of 

electronic data exchange. 

Aside from a primary care 

physician, a pharmacy is a 

significant source of health 

care for many people. 

Barcoding vaccines is 

regarded as a tool for 

quality assurance. 

(continued) 

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Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

Table 4-1. Summary of Anticipated Barriers and Facilitators to Adopting 

Barcoded Vaccines by Provider Group (continued) 

Provider 

Anticipated Barriers to 

Adopting Vaccine 

Barcoding 

Anticipated Facilitators 

to Adopting Vaccine 

Barcoding Comments 

Immunization 

clinic 

providers, 

Maxim Health 

Care 

>90% of vaccine doses 

drawn from multidose vials. 

Lack of fixed location 

presents challenge to using 

bulky technology/ 

equipment that is difficult to 

move. 

Limited integration into 

health care system. 

Some clinic providers are 

using e-books or similar 

devices to facilitate data 

collection and reporting. 

Immunization clinic 

providers include an array 

of organizations. Some may 

be for-profit companies that 

offer many different 

wellness services; some 

may be small not-for-profit 

organizations that focus on 

immunization only. 

RBCs (CCA) Not all RBCs have 

computerized data 

collection and reporting 

All CCA member RBCs are 

computerized and use 

EHRs. 

Barcoding vaccines is 

regarded as a tool for 

quality assurance. 

systems. Quality assurance is a high 

priority for CCA members. 

LHDs LHDs are public facilities 

with limited resources. 

Potential cost savings 

associated with improved 

efficiency and decreased 

extraimmunization and 

vaccine wastage is a 

potential motivator. 

Although nearly all LHDs 

provide immunization 

services, the degree to 

which they do so varies 

considerably across the 

United States. 

As public health agencies, 

LHDs are a natural partner 

to support IIS. 

The RTI team also interviewed staff and observed immunization practices at Altamonte 

Pediatrics, a pediatric primary care practice in Altamont Springs, FL. The purpose of the visit 

was to observe clinical and administrative procedures and discuss questions to be included 

in stakeholder discussion guides and the internet survey. The observations consisted of 

shadowing staff who demonstrated processes and systems associated with vaccine 

management, immunization practice, and record keeping. Throughout the observations, the 

project team asked both clarifying and open-ended questions. In addition, we reviewed 

documentation in both paper-based and electronic systems. This review encompassed 

processes from ordering through billing. Although we visited a single pediatric practice, the 

office’s medical director is co-chair of the American Academy of Pediatrics’ Automated 

Identification of Vaccine Products Committee. Thus, he represents AAP, explaining how 

workflows and policies in his practice compare with those in other pediatric practices 

throughout the country. 

4.1.3 Complementary Immunization Providers 

Although most vaccines are believed to be administered in a primary care setting, a 

considerable volume of vaccine, especially the seasonal influenza vaccine, is administered 

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Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

outside primary care settings. Walgreen’s, for example, administered over 6 million flu shots 

during the 2010/11 influenza campaign (Walgreens, 2011). As immunization programs 

expand their efforts to immunize adolescents and adults (who are less likely to have regular 

contact with primary care providers), the role of complementary immunization providers is 

likely to increase. 

For complementary immunization providers, we conducted initial key informant interviews 

with representatives from relevant professional and/or trade. In addition, we used a 

modified snowball sampling approach in which we interviewed additional organizations 

recommended to us by these groups until no new organizations were recommended. For 

example, to obtain a comprehensive understanding of immunization practice in LHDs, we 

spoke with representatives from the National Association of County and City Health Officials 

(NACCHO) and individual health officials. Community immunizers were represented by a key 

informant, Maxim Health Services, that served as a de facto spokesperson for community 

immunizers. In addition, we spoke with a representative from the American Hospital 

Association, who spoke on behalf of hospitals, and the American Pharmacy Association 

(APhA). 

4.1.4	 Public-Sector Immunization Organizations 

In addition to interviews with organizations representing immunization providers, we 

conducted a group interview with immunization program managers of CDC’s 317 

Immunization Grant Program, with a focus on program managers’ knowledge and feedback 

regarding 2D vaccine barcoding. Telephone interviews were conducted with Association of 

Immunization Managers (AIM), American Immunization Registry Association (AIRA), Public 

Health Agency of Canada, and 18 out of the 20 immunization information systems (IIS) that 

received interoperability grants from CDC. 

4.2	 Internet Survey of Primary Care Physicians and Local Health 

Officials 

RTI fielded an internet survey of primary care providers and local health officials between 

April 19 and June 1, 2011. The instrument was developed based on information from the 

literature review, key informant interviews, and input from CDC. The survey is included as 

Appendix D. 

The project’s timeline and available resources precluded conducting a representative sample 

survey. Instead, we developed a marketing strategy “Take 10 to Enhance Vaccine Barcodes” 

and partnered with AAP, AAFP, ACOG, AMA, NACCHO, the Association of Immunization 

Managers, and Vaccines for Children (VFC) Program coordinators to promote the survey 

(see Figure 4-1). Partnering organizations received electronic files that included PDF and MS 

Word documents containing descriptions about and links to the web-based survey. To 

encourage participation in the survey, respondents were entered into a raffle to receive one 

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Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

Figure 4-1. Take 10 to Enhance Vaccine Barcodes Survey Announcement 

of 10 Apple iPads. Participating VFC jurisdictions received survey results compiled for their 

jurisdiction. 

4.2.1 Survey Population 

The targeted survey population was pediatric, family medicine, internal medicine, and obgyn practices, as well as LHDs. Although there are many other immunization providers, 

including pharmacists, RBCs, and community immunizers, CDC recommended a focus on 

primary care practices and LHDs. Anecdotal evidence and a review of the ACIPrecommended immunization schedule suggests that these providers administer the majority 

of immunizations. 

Respondent profile data were used to extrapolate survey responses to the population of 

practices meeting the same specialty and size criteria. We used the count of practices by 

physician specialty from the Group Practice Database, part of the AMA Physician Masterfile 

Data Collection (AMA, 2011). We estimated the percentage of practices by specialty falling 

in our defined size categories using data from the 2008 Physician Practice Information 

Survey (AMA, 2008). For LHDs, we relied on the NACCHO Directory of Local Health 

Departments for an estimate of the total number of LHDs (NACCHO, 2010). 

In essence, this approach assumed that respondents within the same specialty-size 

category were representative of all the practices in that category. Although a representative 

sample would have been ideal, the survey focused primarily on immunization-associated 

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Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

workflow, staffing structure, and activity measures, which are expected to be more 

consistent among practices than attitudinal information would be. 

4.2.2 Survey Question Development and Pretesting 

Table 4-2 presents the survey topics. Survey topics and response selections were developed 

through a review of the literature; a review of the Canadian benefit-cost analysis (HDR, 

2009); assessment of the needs of the economic model; and interviewees’ perspectives of 

barriers, facilitators, and technical assistance needs. We strove to increase survey 

completion by minimizing the effort required to complete the survey. The survey was 

designed to be completed in 10 minutes, not including the time that may be required for a 

respondent to obtain data on the number of doses administered per year. Questions were 

limited to only those questions that were minimally sufficient to capture practices’ 

perspectives and populate economic models. 

Table 4-2. Survey Question Topics 

Survey Section, 

Question Item Selections or Entries 

Respondent profile 

Zip code 5-digit zip code 

Medical specialty Pediatrics, family practice, ob-gyn, internal medicine, other (specify) 

Primary setting Physician office, solo practice; physician office, single-specialty group 

practice; multispecialty group practice or clinic; teaching hospital; 

nonteaching hospital; other (specify) 

Size Number of staff in practice, and number that prepare and administer 

vaccines, for the following positions: physicians, physician assistants, 

nurse practitioners, registered nurses, licensed practical nurses, and 

medical assistants 

Immunization activity 

measures 

Administration of Yes or no to administering childhood vaccines, adolescent vaccines, adult 

vaccine product vaccines, and travelers’ vaccines 

categories 

Number of doses Childhood vaccines, adolescent vaccines, adult vaccines, and travelers’ 

administered per year vaccines; influenza vaccines (2010–2011 seasona

) 

VFC provider Yes or no to participation in the VFC Program 

Percentage VFC doses Percentage of pediatric and adolescent doses that are VFC doses 

Work areas for Number of nurses’ stations, dedicated rooms for immunization or 

vaccine preparation laboratories, examination rooms, other (specify) 

(continued) 

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Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

Table 4-2. Survey Question Topics (continued) 

Survey Section, 

Question Item Selections or Entries 

Existing IT infrastructure 

Current systems Use of EHRs, practice management and billing; automated input devices 

(e.g., weight scales or blood pressure); barcode or barcode scanning of 

any type for medical supplies, encounter forms, or documentation; other 

(specify) 

EHR adoption horizon If no EHR system, expected adoption by end of 2011, 2012, 2013, 2014, 

2015, after 2015, or not sure or have no plans to adopt 

EHR capable of 

recording expiration 

date and lot number 

Availability of expiration date and lot number fields in EHR 

Inventory systems Registry- or internet-enabled system, inventory software system, system 

that is part of practice management or billing system, spreadsheets, 

paper-based systems, none (simply order when stock looks low), other 

IIS reporting Yes or no to reporting to IIS 

IIS reporting method If report to IIS, yes or no to methods, and percentage of records 

uploaded, by automated upload, manual entry, facsimile, other (specify) 

Perceptions of 2D barcode 

utility 

Use of 2D barcode, if 

available 

Yes, my practice would use the barcode; My practice would likely use the 

barcode if we had an EHR system; No, my practice would not likely use 

the barcode; I don’t know if my practice would use the barcode 

More likely to report 

to IIS 

If use barcode but do not report to IIS, yes, no, unsure or don’t know 

Use of barcoded VIS, 

if available 

Yes or no 

Technical assistance	 

needs	 

Software support for integration with EHR, software support for integration 

with practice management system, software development for integration 

with IIS, guidance for integration of barcode with workflow for 

immunization, staff training, scanner selection and installation, other 

(specify) [Yes or no] 

Adoption factors Cost of scanners, changes to workflow, training, reliability of barcodes, 

readability of barcodes, usability of barcode scanners, increased accuracy 

of records, decreased time spent recording vaccines information or 

documenting immunization; more efficient and accurate management of 

inventory; potential decrease in the number of vaccines that do not get 

billed to a private payer [unimportant, somewhat unimportant, neutral, 

important, very important] 

Comments Comments entry 

Survey awareness E-mail, postcard, newsletter, word of mouth, other (specify) 

Raffle entry Name, address, e-mail, telephone number 

a

The survey asked respondents to answer regarding TIV or LAIV for seasonal influenza, not 

monovalent influenza vaccine for novel H1N1. 

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Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

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Survey respondents provided the number of doses administered per year by their practice. 

The survey was also designed to capture information on the number of staff that may need 

training and the number of scanners that the practice may require, given that scanners 

were expected by professional association representatives to be installed at nurses’ stations 

or in laboratories. Respondents were also asked to provide information on the information 

systems (e.g., EHRs, IIS, practice management systems) they have installed in their 

practices and to answer questions about whether they would use the 2D barcode and what 

types of technical assistance they may need. 

Draft survey instruments were reviewed by CDC, AAP, vaccine manufacturers, members of 

the Canadian Automated Identification of Vaccine Products Advisory Task Group, the Verden 

Group, and immunization policy and practice management experts at RTI. The penultimate 

draft survey instrument was pretested with 14 pediatric practices and 1 ob-gyn practice and 

was revised based on their feedback.2 

4.2.3 Survey Hosting, Availability, and Distribution 

The survey was available online at http://vaccinebarcodingsurvey.rti.org between April 19 

and June 1, 2011. Promotional materials included e-mails, sample articles for inclusion in 

newsletters, blast fax material, and example images. Survey partners included AAP, AAFP, 

ACOG, AIM, NACCHO, and VFC coordinators for many VFC jurisdictions (see Table 4-3). 

The frequency of communications was determined by the partner, although RTI did follow 

up with partners via phone and/or e-mail to encourage partners’ promotion of the survey. 

Generally, e-mails were sent 2 to 3 times at regular intervals over the survey period, blast 

faxes were sent 1 to 2 times, and newsletter mentions occurred once (national distribution) 

or 2 to 3 times (local distribution). 

Because the survey results for individual VFC jurisdictions would assist immunization 

program managers and VFC coordinators with understanding the needs and characteristics 

of their jurisdictions, RTI agreed to provide participating jurisdictions with summary results 

for their jurisdictions alone, following the completion of the national analysis. 

4.3 Survey Response 

The total number of surveys with at least one question answered was 4,568, but after data 

cleaning and application of our criteria for what constituted a valid response, this number 

was reduced by 19.7% to 3,669. Of these 3,669 responses, 2,816 were private-practice 

respondents and 853 were LHD respondents. 

2

Pretesters received a $25 gift certificate to amazon.com in appreciation for their participation. 

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Table 4-3. Survey Distribution Mechanisms 

Survey Partner	 Survey Distribution Mechanisms 

AAP	 E-mails to Section on Practice Management (section), Community Physicians 

(section), Young Pediatricians (section), Infectious Disease (listserv); 

Inclusion in AAP On Call, Immunization Update, AAP Smart Brief 

American Association of 

Family Practitioners 

Inclusion in AAFP News Now; direct link from AAFP web site to survey web 

site 

ACOG E-mail to all listserv subscribers; inclusion in Immunization News 

NACCHO Inclusion in NACCHO Connect; mentions in monthly updates to statewide 

organizations 

VFC Program 

coordinators and 

immunization program 

managers 

E-mail listservs, blast fax, and newsletters distributed to VFC providers in 

Arizona, Arkansas, California, Chicago, Colorado, Connecticut, Delaware, 

Florida, Georgia, Idaho, Indiana, Kansas, Kentucky, Louisiana, 

Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New 

York, New York City, North Carolina, North Dakota, Ohio, Oregon, 

Pennsylvania, Philadelphia, Puerto Rico, South Carolina, South Dakota, 

Texas, Utah, Virginia, West Virginia, and Wyoming. Information on 

technology adoption patterns was provided by Washington, Wisconsin, and 

Wyominga 

a

Jurisdictions declining to participate because of resource constraints or competing surveys in the field 

were Alaska, Hawaii, Illinois, Iowa, Minnesota, Mississippi, Montana, New Hampshire, San Antonio, 

Tennessee, and Washington. The remaining jurisdictions were not responsive to e-mail and 

telephone requests for participation. 

If respondents did not provide a valid response for their practice specialty or for the total 

number of physicians in their practice, their responses were excluded from the survey. We 

also excluded outlier responses to the number of doses per physician, and duplicate records 

based on the respondents contact information (last record entered will be considered the 

valid record).3 

3

Respondents occasionally entered nonnumeric data for questions that included numeric calculations. 

These responses were evaluated individually and were estimated or set as missing based on the 

following criteria. Range—If a respondent gave a range of values, for example, 3 to 5, the midpoint 

was used (4). Lower bound—If a respondent provided a lower bound, for example, 100+, the 

bounded value was used (100). Uncertain description—If a respondent gave an uncertain 

description, for example, “many” or “hundreds,” the value was set as missing for the purposes of 

analysis. Invalid responses—Responses requiring a percentage must fall between 0 and 100. Values 

over 100 were assumed to have misinterpreted the question to provide the total number rather 

than the percentage. If a value was over 100, and we had an appropriate denominator, for 

example, total number of vaccines, then we estimated the percentage. Values without an 

appropriate denominator were set as missing for the purposes of analysis. Interpreting missing 

values as zeros—For questions with multiple numeric responses, missing responses were 

interpreted as zero if the respondent provided answers to part of the question, for example, 

provider total number of physicians and medical assistants but left blank number of nurse 

practitioners, we assumed 0 nurse practitioners. If no responses were provided to questions with 

multiple numeric responses, missing responses were interpreted as missing. For questions without 

multiple numeric responses, such as the number of flu doses administered, missing responses were 

interpreted as zero. 

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The number of responses varied greatly by specialty; the largest number of responses came 

from pediatrics and the lowest came from internal medicine physicians (see Table 4-4). Out 

of an estimated population of 4,937 pediatric practices (according to AMA), 1,442 valid

responses were received, equating to an estimated coverage rate of 29.2%. We received 

968 valid responses from family practices, equating to a 10.1% coverage rate. Only 101 

valid responses were from ob-gyn practices (1.8%) and 57 from internal medicine practices 

(0.5%). 

Table 4-4. Estimated Survey Coverage for Primary Care Practices and Health 

Departments

Specialty Practice Size

Survey Responses

AMA Masterfile and 

PPI Data Estimated 

Survey 

Count Percent Count Percent Coverage

Pediatrics 1–1.5 physicians 408 28.3% 1,392 28.2% 29.3%

2–9 physicians 889 61.7% 2,582 52.3% 34.4%

More than 10 

physicians

145 10.1% 963 19.5% 15.1%

Total 1,442 100% 4,937 100% 29.2%

Family 

practice

1–1.5 physicians 362 37.4% 3,146 32.9% 11.5%

2–9 physicians 497 51.3% 5,173 54.1% 9.6%

More than 10 

physicians

109 11.3% 1,243 13.0% 8.8%

Total 968 100% 9,561 100% 10.1%

Ob-gyn 1–1.5 physicians 17 16.8% 1,592 27.8% 1.1%

2–9 physicians 61 60.4% 3,481 60.8% 1.8%

More than 10 

physicians

23 22.8% 653 11.4% 3.5%

Total 101 100% 5,725 100% 1.8%

Internal 

medicine

1–1.5 physicians 28 49.1% 4,947 39.7% 0.6%

2–9 physicians 25 43.9% 5,197 41.7% 0.5%

More than 10 

physicians

4 7.0% 2,318 18.6% 0.2%

Total 57 100% 12,462 100% 0.5%

Total of identified specialties 2,568

 

 

 

 

32,685 7.9%

Other 248

Total of private-practice 

responses

2,816

Total of health departments 853

Total responses 3,669

Source: RTI International and AMA (2008, 2011).
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

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In the survey, 2,775 respondents answered with a valid zip code. Using these zip codes, we 

linked respondents to their respective cities and counties. We received responses from

providers in 54 out of the 64 VFC jurisdictions, including all cities and Washington, DC, and 

47 out of 50 states. Puerto Rico was the only U.S. territory VFC jurisdiction with provider 

responses. For LHDs, we received responses from four cities, 36 states, and Puerto Rico 

(see Figures 4-2 and 4-3). Appendix E provides a count of the responses by jurisdiction.

Figure 4-2. Primary Care Provider Survey Response, by 4-Digit Zip Code

Figure 4-3. Health Department Survey Response, by 4-Digit Zip Code
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

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4.4 Average Number of Staff per Practice

Table 4-5 presents our survey responses for the average number of primary care office staff 

per practice in total, as well as the number of staff who prepare vaccines for administration 

and the number of staff who administer vaccines. As anticipated, registered nurses, medical 

assistants, and licensed practical nurses are more likely than physicians, physician 

assistants, or nurse practitioners to prepare or administer vaccines. These findings have 

implications both for the economic benefits, given that wage rates vary by training and 

positions, and for the orientation and development of training materials.

For example, among responding practices, a pediatric practice in the 2 to 9 physicians size 

category has 12.6 FTEs in medical positions on average. Of these, on average, 7.3 prepare 

vaccines and 7.1 administer them. The average number of physicians was 4.0, but they are 

not likely to prepare or administer immunizations. That responsibility is more likely to be 

performed by registered nurses or medical assistants. 

Table 4-6 summarizes the average number of staff in physician, nursing, and assistant

positions in LHDs. Registered nurses are the most numerous and the most likely to prepare 

and administer vaccines in LHD settings.

4.5 Average Number of Vaccines Administered

The average number of doses administered per year by specialty and size is presented in 

Tables 4-7 and 4-8. Analyzing the potential to reduce the amount of time spent on 

documentation requires an understanding of the total volume of doses administered by 

practices on an annual basis. Assuming that there is no difference in the profile of staff 

administering vaccines among pediatric, adolescent, adult, or influenza vaccines, multiplying 

any time savings by the loaded hourly wage rate weighted by job position and by the 

number of doses administered per year should provide the economic benefit accruing to the 

practice from using scanners to image the 2D barcode and populate EHRs, practice 

management systems, and other record-keeping systems.

The typical pediatric practice administers more vaccines than other primary care practices. 

Compared with family medicine practices, pediatric respondents reported total annual 

vaccines administered to be 2,735 for pediatrics to 936 for family medicine (1 to 1.5 

physicians), 8,891 to 2,632 (2 to 9 physicians), and 38,126 to 8,874 (10 or more 

physicians). Data for internal medicine practices may not be typical of the overall population 

because of the low number of responses and because the practices that did respond 

administered a large number of childhood vaccines. 

 
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Table 4-5. Mean Number of Staff in Physician, Nursing, and Assistant Positions in Primary Care Practices that 

Prepare and Administer Vaccines, by Specialty and Practice Size

Specialty Staff Positions

How Many Total Staff Are in These 

Positions at Your Practice?

How Many of These Staff Prepare 

Vaccines?

How Many of These Staff Administer 

Vaccines?

1–1.5 

Physicians

2–9 

Physicians

More than 10 

Physicians

1–1.5 

Physicians

2–9 

Physicians

More than 10 

Physicians

1–1.5 

Physicians

2–9 

Physicians

More than 10 

Physicians

Pediatrics

(n=1,442)

Physicians 1.0 4.0 34.9 0.4 0.5 3.1 0.5 0.6 4.1

Physician assistants 0.4 0.8 5.0 0.1 0.2 1.8 0.1 0.2 2.1

Nurse practitioners 0.1 0.3 2.0 0.0 0.0 0.8 0.0 0.0 0.8

Registered nurses 0.4 2.1 58.0 0.4 1.9 24.7 0.4 1.9 56.2

Licensed practical 

nurses

0.4 1.7 10.7 0.4 1.6 9.5 0.4 1.6 9.5

Medical assistants 1.6 3.6 20.8 1.4 3.1 10.8 1.3 2.8 10.7

Total 4.0 12.6 131.5 2.7 7.3 50.8 2.7 7.1 83.3

Family practice 

(n=968)

Physicians 1.0 3.8 30.7 0.3 0.3 0.8 0.3 0.4 1.8

Physician assistants 0.5 1.0 4.3 0.2 0.2 0.3 0.2 0.2 0.6

Nurse practitioners 0.4 0.8 1.9 0.1 0.1 0.3 0.1 0.1 0.4

Registered nurses 0.5 1.4 9.6 0.4 1.2 8.3 0.4 1.2 8.0

Licensed practical 

nurses

0.5 1.7 8.6 0.5 1.6 8.5 0.5 1.6 8.3

Medical assistants 1.6 4.6 22.5 1.4 3.9 14.3 1.4 3.8 13.7

Total 4.5 13.3 77.6 2.8 7.2 32.4 2.8 7.3 32.9

Ob-gyn

(n=101)

Physicians 1.0 4.4 20.7 0.5 0.2 1.2 0.5 0.2 1.8

Physician assistants 1.5 1.1 1.6 0.5 0.2 0.3 0.6 0.4 0.4

Nurse practitioners 0.1 0.2 0.7 0.1 0.0 0.2 0.1 0.0 0.2

Registered nurses 0.5 2.2 17.8 0.5 1.8 14.7 0.5 1.9 14.7

Licensed practical 

nurses

0.4 1.5 5.1 0.4 1.4 3.5 0.4 1.4 4.8

Medical assistants 1.8 4.0 6.6 1.0 2.5 4.5 1.0 2.7 3.9

Total 5.4 13.4 52.5 3.1 6.2 24.5 3.1 6.7 25.8

Internal 

medicine

(n=57)

Physicians 1.0 4.1 22.5 0.7 0.6 3.8 0.6 0.8 3.8

Physician assistants 0.2 1.4 2.5 0.1 0.4 0.5 0.1 0.5 0.5

Nurse practitioners 0.2 0.4 2.3 0.1 0.0 0.5 0.1 0.0 0.5

Registered nurses 0.2 1.6 13.8 0.2 1.4 13.8 0.2 1.4 13.8

Licensed practical 

nurses

0.2 1.1 10.0 0.2 1.1 2.5 0.2 1.1 2.5

Medical assistants 1.1 4.8 15.5 0.9 3.6 0.0 0.9 3.8 0.0

Total 2.9 13.4 66.5 2.1 7.1 21.0 2.1 7.7 21.0

Note: Sums may not add to totals because of independent rounding.
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Table 4-6. Average Number of Staff in Physician, Nursing, and Assistant 

Positions that Prepare and Administer Vaccines in Local Health 

Departments

Staff Positions 

(n=853)

How Many Total Staff 

Are in These Positions 

at Your Practice?

How Many of These 

Staff Prepare 

Vaccines?

How Many of These 

Staff Administer 

Vaccines?

Physicians 2.7 0.1 0.1

Physician assistants 0.8 0.3 0.3

Nurse practitioners 0.1 0.1 0.1

Registered nurses 8.7 5.7 5.7

Licensed practical nurses 0.8 0.6 0.6

Medical assistants 0.5 0.3 0.2

Total 13.5 7.0 7.1

Note: Sums may not add to totals because of independent rounding 

The number of locations where immunizers prepare vaccines for administration has bearing 

on the number of scanners that would be necessary to implement 2D barcoding. Table 4-9 

summarizes the number of locations in primary care settings or LHDs where vaccines are 

prepared for administration. Our conversations with professional associations revealed that 

providers are most likely to locate scanners at nurses’ stations and labs because these are 

likely to be outfitted with refrigerators already, allowing the immunizer to scan the product 

as it is removed from storage. The typical family practice may need 4 to 7 scanners and the 

typical health department may need 7 to 13. 
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

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Table 4-7. Average Number of Doses Administered per Year by Primary Care 

Practices, by Specialty and Practice Size

Specialty Vaccine Type

Average Annual Doses Administered

by Practice Size

1–1.5 

Physicians 2–9 Physicians

More than 10 

Physicians

Pediatrics

(n=1,369)

Childhood vaccines 1,842 5,885 27,409

Adolescent vaccines 457 1,316 4,267 

Adult vaccines 15 60 745

Travelers’ vaccines 4 9 135

Flu 417 1,621 5,570

Total 2,735 8,891 38,126

Family practice

(n=925)

Childhood vaccines 416 1,049 4,044

Adolescent vaccines 151 367 1,096

Adult vaccines 88 337 1,134

Travelers’ vaccines 6 11 58

Flu 275 868 2,542

Total 936 2,632 8,874

Ob-gyn

(n=101)

Childhood vaccines 49 23 439

Adolescent vaccines 72 89 199

Adult vaccines 48 128 328

Travelers’ vaccines — 1 — 

Flu 91 323 683

Total 260 564 1,649

Internal medicine

(n=51)

Childhood vaccines 70 982 200

Adolescent vaccines 59 425 5 

Adult vaccines 159 602 2,783

Travelers’ vaccines 4 26 433

Flu 265 992 1,350

Total 557 3,027 4,771

Table 4-8. Average Number of Doses Administered per Year by Health 

Departments

Specialty Vaccine Type Average Annual Doses Administered

Health 

departments

(n=853)

Childhood vaccines 2,363

Adolescent vaccines 1,178

Adult vaccines 847

Travelers’ vaccines 97

Flu 1,585

Total 6,070
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Table 4-9. Average Number of Locations within Primary Care Practice and Health 

Departments Where Vaccines Are Prepared for Administration, by 

Specialty and Practice Size

Specialty

Nurses’ 

Stations

Dedicated 

Rooms for 

Immunization 

or 

Laboratories

Examination 

Rooms Others

Absolute 

Number 

of 

Scannersa

Pediatrics (n=1,304) 1.4 1.7 4.4 0.1 4 to 5

1–1.5 physicians 0.7 0.9 1.5 0.1 2 

2–9 physicians 1.3 1.8 4.8 0.0 3 to 5

More than 10 physicians 4.8 4.3 13.2 0.1 9 to 13

Family practice (n=879) 1.7 2.1 6.2 0.1 4 to 7

1–1.5 physicians 0.7 1.7 1.6 0.0 2 to 3

2–9 physicians 1.4 1.7 4.7 0.1 4 to 5

More than 10 physicians 6.5 5.4 31.7 0.1 12 to 32

Ob-gyn (n=97) 1.8 0.9 5.5 0.5 3 to 6

1–1.5 physicians 0.8 0.9 2.4 0.0 2 to 3

2–9 physicians 1.7 0.6 4.6 0.1 2 to 5

More than 10 physicians 3.5 1.3 11.9 2.2 7 to 12

Internal medicine (n=55) 1.8 1.1 4.5 0.0 3 to 5

1–1.5 physicians 0.4 0.6 2.0 0.0 2 

2–9 physicians 1.5 1.8 7.0 0.0 4 to 7

More than 10 physicians 3.0 0.3 10.3 0.0 4 to 11

Health departments 

(n=806)

2.2 4.8 4.4 13 7 to 13

a

The number of scanners range represents the absolute value of the sum of nurses’ states and 

dedicated rooms for immunization or laboratories compared with the absolute value of the greater of 

examination rooms or other. 

4.6 IT Infrastructure

To understand the information systems that primary care practices and LHDs have in place, 

respondents were asked to indicate whether they had an EHR, practice management and 

billing system, automated data input devices (e.g., computer-connected weight scales or 

blood pressure devices), and barcoding or barcode scanning system. Family and ob-gyn 

practices were more likely to use EHRs (69.3% and 66.7%, respectively) than pediatric 

practices (58.9%) and internal medicine practices (52.6%). Slightly more than one-third of 

LHDs reported having some form of EHR (Table 4-10). 

Most respondents reported having practice management and billing systems: greater than 

80% of respondents for primary care practices and 67.5% for LHDs. Use of automated input 
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

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Table 4-10. Percentage of Primary Care Practices and Health Departments Currently Using Computerized 

Systems, by Specialty and Practice Size 

Specialty

(n= practices)

Electronic 

Health Record 

System

Practice 

Management and 

Billing System

Automated Data 

Input Devices, 

such as Weight 

Scales or Blood 

Pressure Devices

Barcoding and 

Barcode Scanning 

of any Type for 

Medical Supplies, 

Encounter Forms, 

Documentation, 

etc.

Other 

Computerized 

System

Pediatrics (n=1,293) 58.9% 87.6% 27.6% 11.5% 24.1%

1–1.5 physicians 44.0% 83.9% 30.3% 8.6% 23.6%

2–9 physicians 62.2% 88.8% 26.2% 10.9% 22.8%

More than 10 physicians 79.9% 90.8% 28.8% 22.6% 33.3%

Family practice (n=882) 69.3% 86.9% 32.0% 12.6% 20.9%

1–1.5 physicians 59.7% 82.7% 29.9% 9.9% 20.6%

2–9 physicians 71.9% 88.9% 32.2% 13.5% 21.6%

More than 10 physicians 89.9% 91.8% 38.4% 18.2% 19.0%

Ob-gyn (n=96) 66.7% 88.3% 25.3% 20.0% 19.7%

1–1.5 physicians 41.2% 93.8% 11.8% 11.8% 38.5%

2–9 physicians 70.2% 89.3% 21.2% 16.4% 19.5%

More than 10 physicians 77.3% 81.8% 45.5% 34.8% N/A

Internal medicine (n=57) 52.6% 83.6% 29.8% 12.3% 22.2%

1–1.5 physicians 46.4% 73.1% 14.3% 7.1% 22.7%

2–9 physicians 56.0% 92.0% 44.0% 16.0% 18.2%

More than 10 physicians 75.0% 100.0% 50.0% 25.0% 33.3%

Health departments 

(n=804)

35.7% 67.5% 27.5% 7.6% 45.1%
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

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devices was less than 33% in general, and the use of barcoding of any type was less than 

20%. Thus, although practice management systems are commonplace, adoption of EHR 

systems and barcode technologies was low (52 to 69%) at the time of the survey. However, 

the rate of EHR adoption is increasing and low adoption of barcodes at the time of the 

survey may be more indicative of utility in relation to workflows rather than reluctance to 

adopt these technologies.

Accordingly, respondents who reported not using an EHR in the spring of 2011 were asked 

when they expected to begin using one, particularly because of American Recovery and 

Reinvestment Act (ARRA) HITECH incentive payments and future changes to Centers for 

Medicare & Medicaid Services (CMS) reimbursement structures. Table 4-11 summarizes 

responses. For pediatric practices, an additional 24% of respondents are expected to have 

adopted some form of EHR system by the end of 2013. Similar growth is expected for family 

medicine (19%), ob-gyn (24%), and internal medicine (30%). In contrast, few LHD 

respondents expected to adopt an EHR system by 2015, and 42% have no plans to adopt 

one.

Vaccine inventory management could be improved by 2D barcodes, particularly if software 

systems (either web based or on site) permit tracking stock on hand. To develop a general 

understanding of inventory management processes employed, practices were requested to 

provide the combination of systems they use to monitor their inventory, selecting from the 

following choices: internet- or registry-based systems, inventory software, inventory 

module that is part of a practice management system, spreadsheets, paper-based systems, 

no system, or other. Based on key informant interviews and survey pretesting, we included 

seven different options for systems used (including “other”). Results show a range and 

combination of methods. With the exception of internal medicine practices (38.5%), more 

than 50% of practices in other specialties reported using paper-based inventory systems 

most, when a system was used (Table 4-12). Notably, 37.7% of pediatric and 43.5% of 

family medicine practices indicated that they simply order when the stock looks low. LHDs 

were most likely to use an internet- or registry-based system. 

4.7 Perceptions of Barcode Benefits, Costs, and Needs

In posing the important question of whether the practice would use the barcode, we 

described the cost and benefit implications in our survey question (Figure 4-4). In 

Table 4-13, we summarize the anticipated likelihood of 2D barcode adoption by provider. 

Possible benefits were presented, as were expected costs for scanners, training, and 

workflow redesign. The results, by specialty, are as follows: 
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Figure 4-4. Survey Question for Primary Care Practices’ and Health Departments’ 

Likelihood to Use 2D Barcodes

Consider the following: The American Academy of Pediatrics (AAP) is recommending that labels on vaccine vials 

and syringes have a two-dimensional barcode containing product name, expiration date, and lot number (see 

Figures 1 and 2). 

Rather than have staff read and manually enter this information into records and forms, the information could be 

automatically scanned into your computer systems (patient records, practice management system, etc.) using an 

inexpensive handheld or tabletop reader. You could also use barcodes to track and manage vaccine inventory and 

insure vaccines administered are recorded in your practice management and billing system.

Using barcodes to record vaccine information in patient records may take less time, be more accurate, and insure 

the proper vaccine is being administered. Using barcodes to manage vaccine inventory could decrease staff time 

spent to manually track inventory and could also insure proper billing of all vaccines administered. 

Changes to practices include purchasing scanners (which cost about $300 each), training staff to use the barcode 

scanners, and modifying your computer systems to accept input from the barcode reader.

Based on this description, do you think your practice would use the barcode? Please select one choice. 

• Yes, my practice would likely use the barcode. 

• My practice would likely use the barcode if we had an Electronic Health Record system. 

• No, my practice would not likely use the barcode. 

• I do not know if my practice would use the barcode. 

Figure 1: Example of linear barcode

Current linear barcodes required by the FDA 

contain only the vaccine product identification 

information. 

Figure 2: Example of two-dimensional barcode

A two-dimensional, or data matrix, barcode can 

include product identification information as well as lot 

number and expiration date.

 43.0% of pediatric practices would likely use the barcode, and an additional 19.5% 

would use it if they had an EHR system. Only 4.0% said they would not use it, and 

only 16.5% said they did not know if they would use it.

 53.5% of family medicine practices would likely use the barcode, 16.3% would use it 

if they had an EHR system, 7.0% would not use it, and 23.2% said they did not 

know if they would use it. 

 Less than half of ob-gyn (48.9%) and internal medicine (34.5%) practices said they 

would use it. In addition, 20% of ob-gyn practices and 36.4% of internal medicine 

practices said they do not know whether they would use it. These results must be 

interpreted cautiously because of the low number of responses for these two 

specialties.

 39.2% of LHDs would likely use the barcode, 26.3% would use it if they had an EHR 

system, 3.6% would not use it, and 30.9% said they did not know if they would use 

it.
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

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Table 4-11. Percentage of Primary Care Practices and Health Departments without EHR Systems Currently, but 

Expecting to Adopt Them in the Future, by Specialty and Practice Size, 2011–2015 

Specialty

(n = practices)

By the End 

of 2011

By the End 

of 2012

By the End 

of 2013

By the End 

of 2014

By the End 

of 2015 After 2015

Not Sure or 

Have No 

Plans to 

Adopt

Pediatrics (n=1,290) 70% 83% 87% 88% 89% 89% 11%

1–1.5 physicians 59% 74% 78% 79% 79% 80% 20%

2–9 physicians 72% 85% 89% 91% 91% 92% 8%

More than 10 physicians 88% 96% 98% 98% 98% 98% 2%

Family practice (n=880) 80% 89% 92% 93% 94% 94% 6%

1–1.5 physicians 73% 83% 86% 87% 88% 88% 12%

2–9 physicians 81% 91% 96% 97% 97% 97% 2%

More than 10 physicians 96% 98% 98% 98% 98% 98% 1%

Ob-gyn (n=95) 77% 90% 94% 94% 95% 95% 5%

1–1.5 physicians 47% 66% 79% 79% 79% 79% 19%

2–9 physicians 82% 96% 98% 98% 98% 98% 2%

More than 10 physicians 86% 91% 95% 95% 100% 100% 0%

Internal medicine (n=57) 70% 82% 84% 84% 84% 84% 16%

1–1.5 physicians 61% 71% 71% 71% 71% 71% 29%

2–9 physicians 76% 92% 96% 96% 96% 96% 4%

More than 10 physicians 100% 100% 100% 100% 100% 100% 0%

Health departments 

(n=808)

40% 49% 53% 55% 56% 58% 42%
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

4-21

Table 4-12. Percentage of Primary Care Practices and Health Departments with Systems or Procedures in Place to 

Monitor the Number of Doses in Stock, by Specialty and Size 

Specialty

Registry- or 

InternetBased 

Inventory 

System

Inventory 

Software 

System 

Installed in 

your Practice 

Computerized 

System that Is 

Part of your 

Practice 

Management 

and Billing 

System

MS Excel 

Spreadsheets 

or Similar Files 

Maintained by 

your Staff

Paper-Based 

Systems, such as a 

Ledger

None; We 

Simply 

Order When 

the Stock 

Looks Low Other

Pediatrics (n=1,229) 43.0% 14.1% 39.3% 31.3% 58.5% 37.7% 13.2%

1–1.5 physicians 50% 15% 38% 28% 63% 36% 11%

2–9 physicians 39% 13% 40% 33% 58% 40% 13%

More than 10 

physicians 

49% 17% 40% 30% 52% 31% 20%

Family practice 

(n=827)

50.5% 12.6% 36.9% 23.4% 53.4% 43.5% 9.2%

1–1.5 physicians 46% 10% 34% 23% 55% 47% 7%

2–9 physicians 56% 14% 38% 23% 52% 43% 12%

More than 10 

physicians 

41% 14% 44% 24% 55% 31% 7%

Ob-gyn (n=91) 24.4% 18.9% 38.5% 18.2% 50.6% 50.0% 6.3%

1–1.5 physicians 40% 13% 27% 27% 63% 55% 0%

2–9 physicians 15% 17% 36% 12% 48% 56% 10%

More than 10 

physicians 

38% 29% 52% 29% 47% 32% 0%

Internal medicine 

(n=52)

25.0% 13.5% 37.3% 28.0% 38.5% 82.2% 25.0%

1–1.5 physicians 16% 4% 28% 30% 32% 88% 0%

2–9 physicians 30% 17% 48% 26% 48% 76% 33%

More than 10 

physicians

50% 50% 33% 25% 25% 50% 100%

Health departments 

(n=792)

69.3% 29.2% 44.5% 32.6% 52.3% 27.3% 9.9%
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

4-22

Table 4-13. Likelihood of Primary Care Practices and Health Departments to Use 2D Barcode

Specialty Practice Size

Yes, My Practice 

Would Likely Use the

Barcode

My Practice Would 

Likely Use the 

Barcode If We Had 

an Electronic 

Health Record 

System

No, My Practice 

Would Not Likely 

Use the Barcode

I Do Not Know If 

My Practice Would 

Use the Barcode

Pediatrics (n=1,226) 1–1.5 physicians 48.5% 26.6% 6.2% 18.8%

2–9 physicians 62.6% 18.0% 3.5% 15.9%

More than 10 

physicians

75.6% 9.2% 1.5% 13.7%

Average 60.0% 19.5% 4.0% 16.5%

Family practice (n=861) 1–1.5 physicians 46.0% 26.6% 6.2% 18.8%

2–9 physicians 54.7% 18.0% 3.5% 15.9%

More than 10 

physicians

74.0% 9.2% 1.5% 13.7%

Average 53.5% 16.3% 7.0% 23.2%

Ob-gyn (n=94) 1–1.5 physicians 31.3% 26.6% 6.2% 18.8%

2–9 physicians 54.7% 18.0% 3.5% 15.9%

More than 10 

physicians

74.0% 9.2% 1.5% 13.7%

Average 48.9% 18.1% 12.8% 20.2%

Internal medicine 

(n=55) 

1–1.5 physicians 31.3% 26.6% 6.2% 18.8%

2–9 physicians 54.7% 18.0% 3.5% 15.9%

More than 10 

physicians

74.0% 9.2% 1.5% 13.7%

Average 34.5% 23.6% 5.5% 36.4%

Health departments 

(n=796)

39.2% 26.3% 3.6% 30.9%
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials

4-23

Among the barriers to taking full advantage of the benefits associated with an IIS is the lack 

of well-populated IIS. Respondents who indicated that they did not report immunizations to 

their IIS but also responded that they would likely use the barcode were asked whether 

they would be more likely to report to IIS if they used the 2D barcode. Table 4-14 reports 

the number and percentage of respondents who reported that they would be more likely to 

report immunization data to IIS if they could use a barcode that included vaccine product, 

expiration date, and lot number.

Table 4-14. Number and Percentage of Primary Care Practices Reporting They Are 

More Likely to Report Immunizations to IIS due to 2D-Barcoded 

Vaccines

Likelihood of Nonreporters to Begin Reporting

Specialty Yes (Percent) No (Percent)

Yes, Likely to 

Begin 

Reporting 

(Percent)

No, Not Likely 

to Begin 

Reporting 

(Percent)

Don’t Know 

(Percent)

Pediatrics 1,073 (84.0%) 205 (16.0%) 54 (51.4%) 11 (10.5%) 40 (38.1%)

Family practice 746 (85.6%) 125 (14.4%) 32 (66.7%) 1 (2.1%) 15 (31.3%)

Ob-gyn 50 (53.8%) 43 (46.2%) 11 (68.8%) 0 (0.0%) 5 (31.3%)

Internal medicine 32 (58.2%) 23 (41.8%) 5 (50.0%) 5 (50.0%) 0 (0.0%)

Total 1,901 (82.8%) 396 (17.2%) 113 (62.8%) 17 (9.4%) 50 (27.8%)

Overall, 113 respondents indicated that they did not report immunizations to IIS currently 

but would be more likely to do so if the 2D barcode were available. Survey results indicate 

that 396 respondents (17.2% of respondents answering these questions) did not report 

immunizations to IIS at the time of the survey. When asked whether 2D barcoding may 

make them more likely to report to IIS, 113 respondents indicated they would be more 

likely to report immunizations to IIS. About 63% of likely 2D barcode users that do not 

report presently would be more likely to do so. 

Implementing any change in immunization practice requires resources. This is particularly 

true when the change in immunization practice involves adopting a new technology. 

Respondents were asked whether they would need a certain type of assistance, and we then 

compared the percentage responding yes to understand which needs seemed to be most 

common. Table 4-15 shows the types of technical assistance that respondents anticipated 

being necessary to implement 2D barcode technology. In order, the most common technical 

assistance needs for respondents were: 

 staff training, 

 software support for integration into EHR systems, and

 scanner selection and installation. 
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

4-24

Table 4-15. Providers’ Perceptions of Types of Technical Assistance Needed to Implement 2D Barcode Scanning

Specialty

Software 

Support for 

Integration 

with Electronic 

Health Record 

System (Rank)

Software 

Support for 

Integration 

with Practice 

Management 

and Billing 

Systems 

(Rank)

Software 

Development 

for Integration 

with your State 

or Local 

Immunization 

Registry 

(Rank)

Guidance for 

Integration of 

the Barcode 

into your 

Practice’s 

Workflow for 

Immunization 

(Rank)

Staff Training 

(Rank)

Scanner 

Selection and 

Installation 

(Rank) Other

Pediatrics (n=1267) 79.9% (2) 62.5% (6) 68.0% (4) 65.2% (5) 80.9% (1) 79.8% (3) 7.7%

Family practice (n=862) 82.3% (2) 59.5% (5) 65.1% (6) 65.2% (4) 84.5% (1) 80.2% (3) 6.5%

Ob-gyn (n=93) 82.8% (1) 68.8% (4) 60.2% (5) 60.2% (6) 79.6% (2) 73.1% (3) 6.5%

Internal medicine (n=55) 74.5% (2) 63.6% (4) 50.9% (6) 52.7% (5) 67.3% (3) 80.0% (1) 5.5%

Health departments 

(n=789)

62.5% (5) 60.7% (6) 75.2% (4) 78.5% (3) 90.5% (1) 87.1% (2) 9.9%

Potential technical assistance needs for each specialty were ranked in ofer from 1 to 6.
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials

4-25

Deciding whether to implement a new technology includes considering a variety of different 

factors. We asked respondents to review various factors and their relative importance in 

deciding whether to implement 2D barcode scanning. Responses were ranked, with

unimportant equal to 0, somewhat unimportant equal to 1, neutral equal to 2, important 

equal to 3, and very important equal to 4. 

Primary care providers, in general, ranked the following decision factors as the five most 

important (Table 4-16; 0 = unimportant, 4 = very important): 

1. increased accuracy of records (mean score = 3.657)

2. decreased time spent recording vaccine information and/or documenting 

immunization (3.631)

3. reliability of the barcodes (3.567)

4. usability of the barcode scanners (3.553)

5. more efficient and accurate management of inventory (3.528)

LHDs, in general, concurred, although they emphasized readability of barcodes over time 

savings from using the barcodes (Table 4-17). Notably, neither primary care providers nor 

LHDs ranked costs, training, or changes to workflow as important. Indeed, changes to 

workflow ranked tenth for primary care and ninth for LHDs. 

4.8 Limitations

The main limitation of this work is that results are from a very large convenience sample of 

3,669 valid responses and not from a nationally representative sample. We expect that 

attitudinal data would be more subject to biases than economic data, because knowledge, 

attitudes, and beliefs are more likely to vary than cost structures within each specialty-size 

combination. The number of immunizations administered may be overrepresented because 

it is possible that immunizers were more likely to receive and agree to take the survey. A 

representative survey was not possible within the short period of performance and resource 

constraints afforded to survey data collection. The second main limitation is that very low 

survey coverage is estimated for ob-gyn and internal medicine practices, and each response 

is weighted heavily because only 100 ob-gyn and 58 internal medicine responses were used 

to analyze readiness and willingness to use 2D barcodes.

4.9 Conclusions

Primary care providers and LHDs are willing to purchase equipment, train employees, and 

redesign workflows as needed to reap the benefits of using 2D barcodes to improve the 

accuracy of records, decrease time spent on documenting immunizations, and improve 

inventory management. Providers cited increased records accuracy and efficiency gains 

from automating documentation as much more important considerations than cost of 

scanners, workflow changes, or training. Furthermore, transitioning to 2D barcoding would 

be in step with increased use of EHRs and other software systems. 
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

4-26

Table 4-16. Stated Importance and Ranking of Factors in Primary Care Providers’ Decision to Use 2D Barcodes 

Factor

(n=2,456) Unimportant

Somewhat 

Unimportant Neutral Important

Very 

Important

Mean 

Scorea Rank

Cost of scanner(s) 2.2% 5.3% 10.1% 35.3% 47.1% 3.198 7 

Possible changes to workflow 3.6% 5.7% 15.8% 39.7% 35.2% 2.972 10

Training 2.0% 4.9% 16.4% 37.7% 39.0% 3.068 9 

Reliability of the barcodes 0.9% 0.9% 5.2% 26.2% 66.7% 3.567 3 

Readability of the barcodes 0.9% 1.1% 6.2% 28.9% 63.0% 3.522 6 

Usability of the barcode 

scanners

0.5% 0.8% 4.1% 32.5% 62.2% 3.553 4 

Increased accuracy of records 0.3% 0.5% 3.8% 23.6% 71.7% 3.657 1 

Decreased time spent 

recording vaccine information 

and/or documenting 

immunization

0.4% 0.5% 5.2% 23.4% 70.5% 3.631 2 

More efficient and accurate 

management of inventory

0.9% 1.2% 6.8% 26.8% 64.4% 3.528 5 

Potential decrease in the 

number of vaccines that do 

not get billed to a private 

payer

4.8% 2.6% 14.8% 25.2% 52.6% 3.182 8 

a

Mean score using a scale in which unimportant = 0 and very important = 4.
Chapter 4 — Knowledge, Attitudes, and Beliefs of Primary Care Providers 

and Local Health Officials 

4-27

Table 4-17. Stated Importance and Ranking of Factors in Health Departments’ Decision to Use 2D Barcodes 

Factor

(n=777) Unimportant

Somewhat 

Unimportant Neutral Important Very Important Mean Scorea Rank

Cost of scanner(s) 1.3% 2.8% 6.8% 29.2% 59.8% 3.4357 7 

Possible changes to 

workflow

3.7% 5.9% 18.2% 42.6% 29.5% 2.883 9 

Training 0.6% 2.7% 9.8% 38.6% 48.2% 3.310 8 

Reliability of the barcodes 0.4% 0.4% 4.4% 20.3% 74.5% 3.682 2 

Readability of the barcodes 0.4% 0.5% 4.6% 24.0% 70.6% 3.684 4 

Usability of the barcode 

scanners

0.4% 0.3% 2.8% 27.2% 69.3% 3.648 3 

Increased accuracy of 

records 

0.3% 0.0% 4.0% 21.3% 74.4% 3.696 1 

Decreased time spent 

recording vaccine 

information and/or 

documenting immunization

0.5% 0.4% 5.0% 31.2% 62.9% 3.555 6 

More efficient and accurate 

management of inventory

0.3% 0.3% 5.1% 26.9% 67.5% 3.611 5 

Potential decrease in the 

number of vaccines that do 

not get billed to a private 

payer

12.1% 3.6% 23.2% 23.3% 37.7% 2.711 10

a

Mean score using a scale in which unimportant = 0 and very important = 4.
 

5-1 

5. ECONOMIC ANALYSIS OF THE IMPACT OF 2D 

BARCODES ON CLINICAL DOCUMENTATION 

Our approach to quantifying economic benefits was to analyze how scanning 2D barcodes 

could reduce the amount of time spent documenting immunizations relative to a businessas-usual case in which product, expiration date, and lot number are recorded by hand while

reading product labels. Other benefits apart from automating some documentation are 

likely; however, quantitative data to estimate them were unavailable. Such benefits include

improved inventory management (including reductions in inventory-carrying costs and

wastage), improved billing through correct product identification, and less 

extraimmunization due to more complete records in immunization information systems

(IIS). 

Our economic model combines survey data on expected barcode usage with time savings 

per dose associated with more efficient documentation. The survey data reviewed in

Chapter 4 provided a wealth of information on readiness to use the barcode and on whether 

providers think they will use it. In this chapter, we discuss the economic model that 

combines survey data, a 33-practice time–motion study of immunization documentation, 

and estimated costs for scanner purchases and maintenance, workflow redesign, and 

training for different practice size–specialty combinations. 

The model estimates that, if primary care practices and local health departments (LHDs) 

follow their stated preferences and use the 2D barcode, net benefits would be $333.6

million over the period from 2013 through 2023 for these stakeholders alone. For whatever 

reasons, providers may not follow their stated preference for 2D barcode use. If the rate of 

adoption were slowed by 50%, net benefits would decline to $326.8 million. If the rate of 

adoption were slowed by 67%, net benefits would decline to $311.3 million. 

Because these estimates only account for a portion of benefits associated with saving time 

on documentation, yet include all expected adoption costs (e.g., cost of scanners, training, 

and workflow redesign), they are conservative.

5.1 Analysis of Time–Motion Study of Immunization 

Documentation and Record Keeping

In 2009, the Verden Group analyzed 36 private practices’ immunization business. This 

assessment included a time–motion study of immunization workflow covering ordering, 

inventory management, administration, record keeping, and billing (Verden Group, 2009). 

The resulting dataset includes activity-specific time–motion estimates for the administration 

of 724 vaccines to 302 patients (cases) at 33 practices (30 pediatric practices, 3 family 

practices) across 17 states. These data were acquired by RTI to serve as the baseline from 
Chapter 5 — Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-2 

which to study the potential time savings generated by using 2D barcodes because each 

step in immunization documentation was a discrete measurement for all cases. 

The Verden Group recruited 36 practices to participate in the study, selecting participants to 

make the study as representative of the administration of pediatric and adolescent vaccines

as possible. Selection criteria included size (number of physicians), state, rurality, specialty, 

electronic health record (EHR) use, and annual number of doses administered. Of 36 

practices, 3 were used to pilot and refine protocols; the time–motion data used in this 

analysis were from the remaining 33 practices. Please see Appendix F for more information.

Across all practices, the amount of time required for vaccine administration averaged less 

than 4 minutes per dose (221 seconds), with a range of 1.5 minutes (92 seconds) to over 7 

minutes (427 seconds).1 The longest process step was the documentation taking place after 

the vaccine was administered at 62.9 seconds. Record keeping accounted for 28% of the 

labor time (Table 5-1).

Table 5-1. Average Time for Immunization Activities

Activity-specific time–motion estimates for the administration of 724 vaccines to 302 patients (cases) 

at 33 practices (30 pediatric practices, 3 family practices) across 17 states.

Step Activity

Average Time in 

Seconds

(95% CI)

Percentage of 

Total Time

1 Patient chart reviews for immunization 2.9 (2.0–3.9) 1 

2 Provision of vaccine information statement − 

3 Patient counseling and obtainment of consent 48.1 (42.8–53.3) 22

4 Ordering vaccine administration 8.0 (6.6–9.3) 4 

5 Preparation of vaccine 59.9 (55.5–64.3) 27

6 Positioning of patient and vaccine administration 33.9 (30.1–37.6) 15

7 Waste disposal and clean-up 5.5 (4.6–6.3) 2 

8 Documentation 62.9 (58.6–67.2) 28

Total 221 (200.2-241.9) 100

Source: RTI based on data acquired from the Verden Group (2009). 

In consultation with the Verden Group and consulting pediatricians, record keeping was 

disaggregated into documentation that is not expected to be eliminated by using 2D 

barcodes (chart notes, Vaccines for Children [VFC] usage sheets [which vary by VFC 

jurisdiction], superbill, other [including parental signatures]) and documentation that could 

 

1

Excludes time spent providing patient the vaccine information statement(process Step 2). Raw data 

were adjusted to account for multiple doses of a pediatric vaccine being administered to a patient 

during one visit.
Chapter 5 — Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-3 

be eliminated by 2D barcodes (logbooks, entry of vaccine details). Documentation that 

would not be affected amounted to 19.2 seconds (Table 5-2). 

Table 5-2. Estimated Change in Documentation Time per Dose, with and without 

an EHR System

Baseline

Documentation Time Relative to 

Baseline

With EHR Without EHR 

Unchanged documentation steps include 

items such as chart notes, VFC usage 

sheets, and superbills

19.2s 19.2s 19.2s

Affected documentation steps

Private dose administration logbook 1.5s −1.5s −1.5s

Recording product, expiration date, and lot...

...in patient records 26.7s −26.7s −26.7s

...in practice management system 8.5s −8.5s −8.5s

...in IIS 4.7s −4.7s −4.0s

...in EHR data fields 2.2s −2.2s − 

Subtotal 43.7s −43.7s −40.8s

2D barcode scan time − +4.3s +4.3s

Total estimated documentation time 62.9s 23.5s 26.4s

Change in documentation time −39.4s −36.5s 

Percentage change in documentation time −63% −58%

S = seconds. Analysis of time–motion study data acquired from the Verden Group (2009), except for 

barcode scan time, which was Pereira et al. (2012).

The amount of time expended on documentation that could be eliminated by scanning a 2D 

barcode was 43.7 seconds per dose at practices with EHRs and 40.8 seconds per dose at 

practices without EHRs. Scanning a vial takes 4.3 seconds on average, according to the 

Canadian inventory pilot (Pereira et al., 2010).2 Thus, we expect that practices with EHRs 

will save approximately 39.4 seconds per dose (95% CI: 34.8–43.9) and practices without 

EHRs will save about 36.5 seconds per dose (32.3–40.5). 

5.2 Economic Model for Quantifying Economic Benefits and Costs

To estimate the number of practices and LHDs adopting barcodes, we estimated unique 

adoption rates for each provider specialty and size category and for LHDs. This rate was 

then multiplied by the total number of practices in each specialty and size category and the 

 

2

The 95% CI is 3.5 to 5.2 seconds per acceptable scan and includes 1.3 attempts per vial to obtain an 

acceptable read.
Chapter 5 — Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-4 

total number of LHDs to estimate the number of practices and LHDs adopting barcodes over 

time. 

To properly allocate the costs and benefits, we developed separate adoption curves to 

estimate the following three parameters: the number of practices and LHDs adopting 

barcodes over time, the number of doses administered using a barcode with an EHR over 

time, and the number of doses administered using a barcode without an EHR over time.

The survey question that describes 2D barcodes and asks whether the respondent’s practice 

or LHD would use the barcode is the primary input for our adoption curves. If the 

respondent answered “Yes, my practice would likely use the barcode,” we assumed that 

barcodes would be adopted in the earliest period available or distributed over some period 

of time as discussed below. For respondents who answered, “My practice would likely use 

the barcode if we had an Electronic Health Record system,” we assumed they will adopt the 

barcode when they expect to have an EHR system in use, as specified in another question. 

Respondents who answered they expect to have an EHR system in use “after 2015” were 

assumed to not adopt an EHR. Respondents who answered “No, my practice would not likely 

use the barcode,” or “I do not know if my practice would use the barcode” were assumed 

not to use the barcode.

To estimate the number of doses administered using a barcode with and without an EHR 

system, we weighted responses by the respondent’s reported number of vaccines 

administered for each provider specialty and size category and for LHDs. This rate was then 

multiplied by the estimated number of doses administered by each specialty and size 

category and LHDs to determine the number of doses administered using a barcode with 

and without an EHR system. 

Respondents who answered “Yes, my practice would likely use the barcode” and whose 

practices currently use an EHR system were categorized as “using a barcode with an EHR.” 

Respondents who answered “Yes, my practice would likely use the barcode” and do not 

currently have an EHR system in place were categorized as “using a barcode without an 

EHR.” These respondents were reassigned to “using a barcode with an EHR” the year they 

expect to have an EHR system in use. 

We estimated three categories of costs for the adoption and use of barcode scanners: 

adoption costs, scanner maintenance costs, and scanner replacement costs. Adoption costs 

were estimated using Equation 5.1: 

AC P (Scan ScanCost WFCost (VaxEmp Wage TrainT )) ijt ∆= ijt ij × + Σ+ kj ijk k ×× (5.1)
Chapter 5 — Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-5 

where

ACijt the total adoption costs for the specialty and size category ij in time t 

∆Pijt the change in practices adopting barcodes in specialty and size category ij

in time t 

Scanij the average number of scanners purchased by practices in specialty and 

size category ij

ScanCost the cost of a barcode scanner

WFCost j the cost of adjusting workflow in practice size category j

VaxEmpijk the average number of employees with occupation k, preparing or 

administering vaccines in specialty and size category ij

Wagek the fully loaded hourly wage rate for occupation k

TrainT the time in hours required to train a staff member to use the barcode 

scanner and review changes in workflow

These parameters provide the total one-time costs for barcode scanning adoption for each 

practice specialty and size category and for LHDs. All dollar values are in real terms (2010). 

Scanner maintenance costs were estimated using Equation 5.2: 

MC (P SCan Maint )Cost = ijtijt ij × (5.2)

where

MCijt the total maintenance costs for the specialty and size category ij in time t

Pijt the number of practices using barcodes in specialty and size category ij in 

time t 

Ma Costint the annual cost of maintaining a barcode scanner

And finally, scanner replacement costs were estimated using Equation 5.3: 

RC Scan ScanCost ijt ij tv −5 ×∆= (5.3)

where

RCijt the total scanner replacement costs for the specialty and size category ij in 

time t 

∆Scanijvt−5 the change in scanners purchased or replaced in specialty and size 

category ij in time tTotal costs for each specialty and size category in a year are thus the sum of adoption 

costs, maintenance costs, and scanner replacement costs. By aggregating the costs across 
Chapter 5 — Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-6 

all specialty and size categories, we can estimate the total cost of 2D barcode adoption for 

the four specialties of providers and LHDs. 

Table 5-3 presents scanner costs, wage rates, and other parameters used to estimate 

economic benefits and costs. In January 2010, RTI’s Information Technology Services group 

reviewed GS1’s technical specifications for reading GTINs and then researched available 

scanners meeting those specifications and suitable for use in a medical setting.3 The 

scanners identified cost between $300 and $350; the lower of these estimates was selected 

because we anticipate that the increase in demand and sales volumes associated with using 

barcodes will likely result in lower market prices. Scanners are expected to have a 5-year 

useful life and annual maintenance costs of 7% (HDR, 2009).

Table 5-3. Wage Rates and Other Estimated Parameters

Variable

Parameter 

Estimate Notes

Scanners

Purchase cost, per scanner

Cost of annual scanner maintenance

Expected life of scanner

Scanner location

Scanner specifications and costs were 

reviewed by RTI in January 2010, and 

the maintenance costs and expected 

useful life were provided by vendors 

(HDR, 2009). Scanners are expected 

to be installed at the point of 

documentation, such as nurses’ 

stations.

$300

$21 (7%)

5 years

1 per station

Labor positions ($/hour)

Licensed practical nurse (LPN)

Medical assistant (MA)

Nurse practitioner (NP)

Physician assistant (PA)

Physician (MD)

Registered nurse (RN)

Cost of employment multiplier

Labor rates were the mean national 

wage rates available from the BLS 

Occupational Employment Statistics 

(OES) for positions (BLS, 2011b). 

OES does not include a wage rate for 

NP, so the rate for PA was used as an 

approximation for NP. The cost of 

employment multiplier to account for 

benefits, payroll taxes, and other 

employment costs was specific to 

health care providers in a nonhospital 

setting (BLS, 2011a).

19.66

14.16

40.78

40.78

77.60

31.99

1.4372

Cost of workflow redesign, practices with 

fewer than 10 physicians, at 8 hours of 

senior RN time

Cost of workflow redesign, practices with at 

least 10 physicians, at 24 hours of senior 

RN time

Training time, per employee

$367.81

$1,103.42

1 hour

Workflow redesign and staff training 

were estimated in consultation with 

VFC jurisdictions, consultants, IIS, 

and IT vendors that have rolled out 

scanner and signature pad usage. 

Labor hours were monetized using 

the 75th percentile wage rate for RNs 

and the cost of employment 

multiplier. 

 

3

See Simplified Guide for U.S. Healthcare Bar Code Scanner Acquisition Criteria at 

http://www.gs1us.org.
Chapter 5 — Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-7 

Discussions with provider associations, individual providers, and IT systems vendors 

indicate that the likely point of scanner installation will be at nurses’ stations or dedicated 

laboratories for immunization. These are the principal places of documentation in common 

immunization practice for medical settings, as well as storage points for vaccine products. 

Products are expected to be scanned as they are removed from the refrigerator. 

Workflow redesign costs and training costs were developed in consultation with IT systems 

vendors, IIS, and VFC jurisdictions that have implemented barcode scanning and/or 

signature pad systems analogous to those needed for 2D barcode scanning. Workflow 

redesign is expected to be appreciably different for large practices with more than 10 

physicians because they have multiple locations. Whereas labor hours for training were 

compensated using mean wage rates for relevant positions, those for workflow redesign 

were compensated using the 75th percentile mean wage rate for registered nurses because

head nurses earning higher wages were expected by interviewees to be charged with 

adjusting and implementing 2D barcode usage plans (Cho, Asay, Lorick, Tipton, Dube, 

Messonnier, 2011). Wage rate and cost of employment multiplier data were obtained from 

the Bureau of Labor Statistics (BLS, 2011a, 2011b). 

The economic benefits quantified in this study are the staff member time savings associated 

with using barcodes in vaccine administration. We estimated these benefits for vaccines 

administered with a barcode and an EHR system using Equation 5.4. 

















Σ

Σ × = ×

ijk

EMR ijk k

ijtvEMR ijtvEMR VaxEmp

dTRe VaxEmp( )Wage B Vax

3600 (5.4)

where

EMR

Bijt monetized benefits of time savings associated with using barcodes in 

vaccine administration with an EHR in specialty and size category ij in time t 

EMR

Vaxijt number of vaccines administered using a barcode with an EHR in specialty 

and size category ij in time t 

dTRe EMR per-dose reduction in time associated with using a barcode in vaccine 

administration with an EHR

Similarly, benefits for vaccines administered using a barcode without an EHR were 

estimated with Equation 5.5. 

















Σ

Σ × = ×

ijk

NOEMR ijk k

ijtvNOEMR ijtvNOEMR VaxEmp

dTRe VaxEmp( )Wage B Vax

3600 (5.5)
Chapter 5 — Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-8 

where

BijtNOEMR monetized benefits of time savings associated with using barcodes in 

vaccine administration without an EHR in specialty and size category ij in 

time t 

VaxijtNOEMR number of vaccines administered using a barcode without an EHR in 

specialty and size category ij in time t 

dTRe NOEMR per-dose reduction in time associated with using a barcode in vaccine 

administration without an EHR

Total benefits for each specialty and size category were calculated as the sum of benefits for 

vaccines administered using barcodes with and without an EHR system. Total benefits for 

using barcodes in vaccine administration for the four provider specialties and LHDs were 

estimated by summing across all specialty and size categories and years. 

5.3 Benefit-Cost Analysis of Impact on Clinical Documentation for 

Primary Care Practices and Local Health Departments

This section begins by reviewing the expected adoption cost per practice and the expected 

documentation benefit per dose, and then reviews three adoption scenarios. The three 

scenarios selected are consistent with the 1-, 2-, and 3-year adoption scenarios ordered in 

the statement of work:

 rate of provider uptake set by survey results (Scenario 1);

 rate of provider uptake slowed by 50%, meaning that the level of adoption that 

would occur in 1 year would occur in 2 years (Scenario 2); and

 rate of provider uptake slowed by 67%, meaning that the level of adoption that 

would occur in 1 year would occur in 3 years (Scenario 3).

5.3.1 Expected Adoption Costs per Practice

Table 5-4 presents the expected adoption cost for practices, including the break out of the 

cost composition for workflow redesign, training, and scanner acquisition. Our cost 

estimates take into consideration differences among specialty and size combinations. These 

costs range from lows of $877 for internal medicine practices with 1 to 1.5 physicians and 

$1,016 for pediatric offices with 1 to 1.5 physicians to a high of $7,831 for pediatric 

practices with 10 or more physicians. 
Chapter 5 

— Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-9

Table 5-4. Estimated Costs for Workflow Redesign, Training, and Scanner Purchases and Maintenance, per 

Practice and Health Department, by Specialty and Size

Specialty Size

Workflow Redesign

Training Expense

Number of ScannersLicensed Practical NurseEquipment ExpenseEstimated Adoption Cost

s (FTEa) 

Medical Assistants (FTE)Nurse Practitioners (FTE)Physician Assistants (FTE)Physicians (FTE)Registered Nurses (FTE)Total Staff (FTE)

Weighted Average Hourly RateTraining Cost

Pediatrics 1–1.5 physicians $437 0.38 1.37 0.03 0.15 0.50 0.38 2.80 $44.47 $124 1.52 $455 $1,016

2–9 physicians $437 1.64 3.11 0.02 0.18 0.61 1.90 7.46 $37.76 $282 3.08 $924 $1,643

More than 10 

physicians

$1,310 9.53 10.81 0.79 2.11 4.20 56.30 83.74 $45.19 $3,785 9.12 $2,736 $7,831

 

Family 

practice

1–1.5 physicians $437 0.46 1.43 0.09 0.18 0.34 0.38 2.88 $39.96 $115 2.36 $708 $1,260

2–9 physicians $437 1.61 3.91 0.07 0.20 0.40 1.24 7.43 $33.22 $247 3.18 $955 $1,639

More than 10 

physicians

$1,310 8.47 14.31 0.40 0.63 1.99 8.29 34.10 $35.62 $1,215 11.97 $3,591 $6,116

 

Ob-gyn 1–1.5 physicians $437 0.41 1.00 0.06 0.59 0.53 0.53 3.12 $50.26 $157 1.71 $512 $1,105

2–9 physicians $437 1.41 2.93 0.05 0.38 0.25 1.93 6.95 $35.24 $245 2.30 $689 $1,371

More than 10 

physicians

$1,310 5.14 4.82 0.22 0.39 1.83 14.73 27.12 $43.54 $1,181 4.83 $1,448 $3,939

 

Internal 

medicine

1–1.5 physicians $437 0.18 0.93 0.07 0.07 0.68 0.18 2.11 $56.41 $119 1.07 $321 $877

2–9 physicians $437 1.12 3.92 0.04 0.52 0.76 1.40 7.76 $38.51 $299 3.25 $975 $1,711

More than 10 

physicians

$1,310 2.50 0.00 0.50 0.50 3.75 13.75 21.00 $57.35 $1,204 3.33 $1,000 $3,515

 

Health Departments $478.83 0.58 0.31 0.06 0.33 0.11 5.79 7.18 $42.65 444 6.42 $1,927 $2,736

a

FTE = Full-time equivalent
Chapter 5 — Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-10

As an example, review the expected cost for family practices with 2 to 9 physicians. On 

average, for practices in this category, we estimate that the adoption cost will be $1,639. Of 

this amount, 

 $437 will be for workflow redesign,

 $955 for scanners installed at an average of 3.18 locations, and

 $247 for training seven to eight staff members to use barcode scanners and review 

how they are to be incorporated into their immunization workflow.4

5.3.2 Estimated Economic Benefits per Dose

Table 5-5 presents the expected documentation benefit per dose. If our example family 

practice with 2 to 9 physicians had an EHR, we would expect that they would save $0.3506

per dose or $0.3244 per dose if they did not have an EHR. Although the savings are less 

than $1, when aggregated over the volume of doses administered over the course of 1 year, 

we expect benefits to be significant. For example, at 10,000 doses the savings would be 

$3,506 or $3,244 per year on more efficient documentation alone, respectively, with or 

without an EHR. 

5.3.3 Forecast of Economic Benefits, Scenario 1: Rate of Adoption Set by 

Survey Results

In this scenario, the rate of adoption is set to 100% of survey respondents’ expectations of 

whether and when they would begin to use the barcode (refer to Tables 4-7 to 4-11 in 

Chapter 4). Around 80% of respondents that expect to use the barcode either have EHRs in 

place currently or expect to have EHRs in place before the barcode is projected to appear on 

labels beginning in 2013. Those survey findings are consistent with the program in place 

under American Recovery and Reinvestment Act (ARRA) HITECH in which practices could 

receive incentives as high as $44,000 to adopt an EHR or face declining reimbursement 

rates from the Centers for Medicare & Medicaid Services (CMS) over time if they do not 

adopt EHRs. Eligible Medicaid providers may earn up to $63,750 over 6 years.

Table 5-6 shows the expected uptake among primary care practices and LHDs. By the close 

of 2015, if practices follow their preferences, we expect that the following numbers of 

practices would use the barcode:

 

4

The training sessions for learning how to use the scanners and reviewing their incorporation into 

practice workflow is expected to be 1 hour per person. The weighted average cost of that hour, 

however, varies with the labor loading. The weighted average hourly wage rate for our example 

practice is $33.22, and because seven or eight people are expected to attend the training, the cost 

is $246.
 

 

Chapter 5 

— Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-11

Table 5-5. Estimated Documentation Benefit per Dose, by Practice and Health Departments, by Specialty and 

Size

Specialty Practice Size

Percentage of Immunization by Occupation

Mean Hourly 

Cost, Wtd by 

Throughput, 

Position

Without EHR With EHR

Licensed 

Practical 

Nurse

(%)

Medical 

Assistant

(%)

Nurse 

Practitioner

(%)

Physician 

Assistant

(%)

Physician

(%)

Registered 

Nurse

(%)

Time 

Savings/

Dose

(seconds) 

Cost 

Savings 

per Dose

($)

Time 

Savings/

Dose

(seconds) 

Cost 

Savings 

per Dose

($)

Pediatrics 1–1.5 physicians 11 56 1 4 17 12 $42.37 36.47 0.4293 39.42 0.4639

2–9 physicians 23 43 0 2 6 26 $35.44 36.47 0.3591 39.42 0.3881

More than 10 

physicians

28 44 1 1 2 24 $31.92 36.47 0.3234 39.42 0.3495

Family 

practice

1–1.5 physicians 12 58 3 6 9 11 $36.66 36.47 0.3714 39.42 0.4014

2–9 physicians 21 53 1 2 4 19 $32.02 36.47 0.3244 39.42 0.3506

More than 10 

physicians

33 42 2 3 1 19 $31.07 36.47 0.3148 39.42 0.3402

Ob-gyn 1–1.5 physicians 17 19 0 18 5 42 $44.75 36.47 0.4534 39.42 0.4900

2–9 physicians 17 31 0 16 10 26 $44.35 36.47 0.4493 39.42 0.4855

More than 10 

physicians

27 11 0 2 4 55 $42.14 36.47 0.4269 39.42 0.4613

Internal 

medicine

1–1.5 physicians 16 44 5 7 20 8 $47.87 36.47 0.4850 39.42 0.5241

2–9 physicians 9 78 1 2 5 5 $28.76 36.47 0.2914 39.42 0.3149

More than 10 

physicians

17 0 3 3 25 52 $61.26 36.47 0.6207 39.42 0.6707

Health Departments 9 5 0 3 1 81 $45.20 36.47 0.4580 39.42 0.4950
 

Chapter 5 – Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-12

Table 5-6. Scenario 1: Forecast of Barcode Adoption, by Specialty and Size (Number of Practices and Health 

Departments) 

Specialty Practice Size

Number 

of 

Practices 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Pediatrics 1–1.5 physicians 1,392 914 918 918 918 918 918 918 918 918 918 918

2–9 physicians 2,582 1,947 1,974 1,987 1,987 1,987 1,987 1,987 1,987 1,987 1,987 1,987

More than 10 physicians 963 807 807 807 807 807 807 807 807 807 807 807

Total 4,937 3,668 3,699 3,712 3,712 3,712 3,712 3,712 3,712 3,712 3,712 3,712

Family 

practice

1–1.5 physicians 3,146 1,905 1,924 1,943 1,943 1,943 1,943 1,943 1,943 1,943 1,943 1,943

2–9 physicians 5,173 3,575 3,586 3,610 3,610 3,610 3,610 3,610 3,610 3,610 3,610 3,610

More than 10 physicians 1,243 968 968 968 968 968 968 968 968 968 968 968

Total 9,561 6,447 6,478 6,521 6,521 6,521 6,521 6,521 6,521 6,521 6,521 6,521

Ob-gyn 1–1.5 physicians 1,592 796 796 796 796 796 796 796 796 796 796 796

2–9 physicians 3,481 2,278 2,278 2,278 2,278 2,278 2,278 2,278 2,278 2,278 2,278 2,278

More than 10 physicians 653 475 475 475 475 475 475 475 475 475 475 475

Total 5,725 3,549 3,549 3,549 3,549 3,549 3,549 3,549 3,549 3,549 3,549 3,549

Internal 

medicine

1–1.5 physicians 4,947 2,016 2,016 2,016 2,016 2,016 2,016 2,016 2,016 2,016 2,016 2,016

2–9 physicians 5,197 3,464 3,464 3,464 3,464 3,464 3,464 3,464 3,464 3,464 3,464 3,464

More than 10 physicians 2,318 1,159 1,159 1,159 1,159 1,159 1,159 1,159 1,159 1,159 1,159 1,159

Total 12,462 6,639 6,639 6,639 6,639 6,639 6,639 6,639 6,639 6,639 6,639 6,639

Total of Identified Specialties 32,685 20,303 20,365 20,421 20,421 20,421 20,421 20,421 20,421 20,421 20,421 20,421

Health Departments 3,669 1,800 1,828 1,841 1,841 1,841 1,841 1,841 1,841 1,841 1,841 1,841

Note: Scenario 1 rate of adoption set by survey response with no adjustments. Ultimate penetration estimated to be 75.2% (pediatrics), 

68.2% (family practice), 62.0% (ob-gyn), 53.3% (internal medicine), and 50.2% (health departments). Practice data are from AMA (2008,

2011) and NAACHO (2011).
Chapter 5 — Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-13 

 3,712 pediatric practices (75.2% of 4,937 practices in the United States) 

 6,521 family medicine practices (68.2% of 9,561)

 3,549 obstetric-gynecology (ob-gyn) practices (62.0% of 5,725) 

 6,639 internal medicine practices (53.3% of 12,462) 

 1,841 LHDs (50.2% of 3,669)

The remaining practices said they would not use the barcode or that they do not know 

whether they would use the barcode.

Total economic benefits from automating product identification and populating expiration 

dates and lot numbers in records are projected to be $447.8 million over 2013 to 2023

(Table 5-7). When the costs for all adopting primary care practices and LHDs are summed, 

the model estimates $114.2 million in costs. Thus, inclusive of adoption and scanner 

maintenance and replacement costs, net benefits are projected to be $333.6 million for 

these stakeholders. 

Continuing with the earlier example of family medicine practices with 2 to 9 physicians, 

Tables 5-6 through 5-9 can be interpreted as follows:

 A total of 3,573 family medicine practices with 2 to 9 physicians are expected to 

purchase scanners and begin using these scanners by the end of 2013. See 

Table 5-6. 

 Annual benefits for these practices amount to $3.9 million in 2014, the first full year 

of barcode use. Benefits from more efficient documentation procedures are low 

during 2013 (the first year of adoption) as practices come online and products enter 

the market with a 2D barcode appearing on the label. Total benefits through 2023 

are $42.4 million. See Table 5-7. 

 Adoption costs for these practices are estimated at $6.1 million in 2013 for workflow 

redesign, scanner purchases, and training. Costs are estimated to be lower in 

subsequent years because the practice is expected to only incur costs for 

miscellaneous scanner replacement costs. The presence of outlays in later years 

represents scanner replacement costs once these units have reached the end of their 

useful life. Total costs through 2023 are $15.4 million. See Table 5-8. 

 For all practices in this specialty–size combination, net benefits of adoption costs are 

negative in 2013 at –$4.2 million, swinging positive in 2014 at $3.6 million, with 

payback achieved early in the third year (2015). Net benefits through 2023 are 

$26.9 million. See Table 5-9. 
 

Chapter 5 

— Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-14

Table 5-7. Scenario 1: Forecast of Documentation Benefits by Practice and Health Department ($ thousands)

Specialty Practice Size 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Total

Pediatrics 1–1.5 physicians 629 1,271 1,282 1,292 1,302 1,311 1,320 1,329 1,338 1,347 1,356 13,776

2–9 physicians 3,691 7,504 7,658 7,748 7,804 7,860 7,916 7,971 8,026 8,081 8,135 82,394

More than 10 physicians 6,028 12,162 12,265 12,360 12,452 12,542 12,632 12,722 12,811 12,899 12,987 131,859

Total 10,348 20,936 21,206 21,400 21,557 21,713 21,868 22,022 22,175 22,327 22,477 228,029

Family practice 1–1.5 physicians 392 796 810 819 826 834 841 848 856 863 870 8,755

2–9 physicians 1,907 3,856 3,907 3,954 3,991 4,029 4,067 4,106 4,143 4,181 4,220 42,362

More than 10 physicians 1,661 3,356 3,390 3,421 3,453 3,485 3,516 3,549 3,581 3,613 3,645 36,670

Total 3,961 8,008 8,107 8,194 8,271 8,347 8,424 8,503 8,580 8,658 8,735 87,788

Ob-gyn 1–1.5 physicians 91 185 187 189 190 192 194 196 198 200 202 2,026

2–9 physicians 293 593 600 607 613 620 627 635 642 649 656 6,535

More than 10 physicians 191 387 393 398 403 407 411 415 419 424 428 4,275

Total 576 1,164 1,179 1,194 1,206 1,219 1,233 1,246 1,260 1,273 1,286 12,836

Internal medicine 1–1.5 physicians 180 363 367 371 374 378 381 385 389 392 396 3,976

2–9 physicians 1,002 2,025 2,046 2,066 2,085 2,105 2,125 2,146 2,166 2,186 2,206 22,158

More than 10 physicians 711 1,438 1,455 1,472 1,489 1,506 1,524 1,542 1,560 1,578 1,596 15,871

Total 1,892 3,826 3,869 3,908 3,949 3,989 4,030 4,073 4,114 4,156 4,198 42,005

Total of Identified Specialties 16,777 33,935 34,360 34,696 34,983 35,269 35,555 35,844 36,129 36,414 36,697

Health Departments 3,436 6,996 7,127 7,202 7,271 7,340 7,409 7,481 7,550 7,621 7,691 77,122

Total 20,213 40,930 41,487 41,898 42,254 42,608 42,964 43,325 43,679 44,034 44,388 447,781

Note: Sums may not add to totals because of independent rounding. Scenario 1 rate of adoption set by survey response with no adjustments. 

Ultimate penetration estimated to be 75.2% (pediatrics), 68.2% (family practice), 62.0% (ob-gyn), 53.3% (internal medicine), and 50.2% 

(health departments). 
 

Chapter 5 

— Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-15

Table 5-8. Scenario 1: Forecast of Adoption and Usage Costs, by Practice and Health Department ($ thousands)

Specialty Practice Size 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Total

Pediatrics 1–1.5 physicians 958 33 29 29 29 445 31 29 29 29 445 2,087

2–9 physicians 3,326 170 150 129 129 1,929 153 141 129 129 1,929 8,312

More than 10 physicians 6,476 155 155 155 155 2,363 155 155 155 155 2,363 12,438

Total 10,759 358 334 312 312 4,737 339 325 312 312 4,737 22,837

Family practice 1–1.5 physicians 2,494 119 120 96 96 1,445 110 110 96 96 1,445 6,227

2–9 physicians 6,098 258 279 241 241 3,656 253 264 241 241 3,656 15,429

More than 10 physicians 6,165 243 243 243 243 3,720 243 243 243 243 3,720 15,552

Total 14,756 620 642 581 581 8,821 606 617 581 581 8,821 37,208

Ob-gyn 1–1.5 physicians 908 29 29 29 29 436 29 29 29 29 436 2,008

2–9 physicians 3,234 110 110 110 110 1,681 110 110 110 110 1,681 7,475

More than 10 physicians 1,918 48 48 48 48 735 48 48 48 48 735 3,773

Total 6,060 187 187 187 187 2,852 187 187 187 187 2,852 13,256

Internal medicine 1–1.5 physicians 1,813 45 45 45 45 693 45 45 45 45 693 3,562

2–9 physicians 6,163 236 236 236 236 3,614 236 236 236 236 3,614 15,283

More than 10 physicians 4,155 81 81 81 81 1,240 81 81 81 81 1,240 7,284

Total 12,131 363 363 363 363 5,548 363 363 363 363 5,548 26,129

Total of Identified Specialties 43,706 1,528 1,525 1,443 1,443 21,957 1,494 1,492 1,443 1,443 21,957

Health Departments 5,166 319 285 248 248 3,715 302 275 248 248 3,715 14,771

Total 48,872 1,847 1,809 1,691 1,691 25,673 1,797 1,767 1,691 1,691 25,673 114,202

Note: Sums may not add to totals because of independent rounding. Annual scanner operations and maintenance expenses are estimated to 

be 7% of the purchase price of $300 per unit. Scanners are assumed to be replaced at 5-year intervals. Scenario 1 rate of adoption set by 

survey response with no adjustments. Ultimate penetration estimated to be 75.2% (pediatrics), 68.2% (family practice), 62.0% (ob-gyn), 

53.3% (internal medicine), and 50.2% (health departments). 
 

Chapter 5 

— Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-16

Table 5-9. Scenario 1: Forecast of Net Benefits by Practice and Health Department ($ thousands)

Specialty Practice Size 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Total

Pediatrics 1–1.5 physicians −328 1,237 1,253 1,263 1,272 866 1,289 1,300 1,309 1,318 911 11,689

2–9 physicians 365 7,334 7,508 7,619 7,676 5,931 7,763 7,830 7,898 7,952 6,206 74,082

More than 10 physicians −447 12,007 12,111 12,205 12,297 10,179 12,477 12,567 12,656 12,745 10,624 119,421

Total −411 20,579 20,872 21,087 21,245 16,976 21,529 21,697 21,863 22,015 17,741 205,192

Family practice 1–1.5 physicians −2,101 677 690 723 730 −611 731 738 759 767 −574 2,528

2–9 physicians −4,190 3,598 3,629 3,713 3,750 373 3,814 3,841 3,902 3,940 564 26,933

More than 10 physicians −4,504 3,112 3,146 3,178 3,210 −235 3,273 3,306 3,338 3,370 −75 21,118

Total −10,795 7,387 7,465 7,613 7,690 −474 7,818 7,886 7,999 8,076 −86 50,580

Ob-gyn 1–1.5 physicians −817 156 158 160 162 −243 166 168 170 172 −233 18

2–9 physicians −2,941 483 490 497 503 −1,060 517 525 532 539 −1,025 −940

More than 10 physicians −1,727 339 345 350 354 −329 363 367 371 376 −307 502

Total −5,484 978 993 1,007 1,020 −1,632 1,046 1,060 1,073 1,086 −1,565 −420

Internal medicine 1–1.5 physicians −1,633 318 322 325 329 −315 336 340 343 347 −297 414

2–9 physicians −5,161 1,788 1,810 1,829 1,849 −1,509 1,889 1,909 1,929 1,949 −1,408 6,875

More than 10 physicians −3,444 1,357 1,374 1,391 1,408 266 1,443 1,461 1,479 1,497 356 8,587

Total −10,238 3,463 3,506 3,545 3,586 −1,558 3,667 3,710 3,751 3,793 −1,350 15,876

Total of Identified Specialties −26,929 32,407 32,835 33,253 33,540 13,311 34,060 34,353 34,686 34,971 14,740

Health Departments −1,730 6,676 6,842 6,954 7,022 3,624 7,107 7,205 7,302 7,372 3,975 62,351

Total −28,659 39,084 39,678 40,207 40,563 16,936 41,167 41,558 41,988 42,343 18,715 333,579

Note: Sums may not add to totals because of independent rounding. Scenario 1 rate of adoption set by survey response with no adjustments. 

Ultimate penetration estimated to be 75.2% (pediatrics), 68.2% (family practice), 62.0% (ob-gyn), 53.3% (internal medicine), and 50.2% 

(health departments). 
Chapter 5 – Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-17

5.3.4 Forecast of Economic Benefits, Scenario 2: Slowing Rate of 

Adoption by 50% 

In Scenario 2, the rate of adoption was slowed by 50%, which is the equivalent of achieving 

the same level of adoption in 2 years instead of 1 year or, alternatively, allowing for the 

rate of adoption to take twice as long as indicated (Table 5-10). The rationale for this 

scenario is because some practices and health departments may not follow their stated 

preferences for using the barcode. Practices may wish to use it, but for whatever reason 

they do not acquire the scanners or invest in workflow redesign at the same rate as 

suggested by the survey response data. In essence, this scenario contributes to a range of 

expected benefits by incorporating a possibility that it takes longer for practices to begin 

using the barcodes. It has the effect of delaying the accrual of costs and benefits and a 

proportion of immunizations that would have been documented using automated data 

capture under Scenario 1 would instead be documented using manual methods. Although 

the ultimate market penetration is the same, net benefits by 2023 amount to $326.8 million 

instead of $333.6 million (Table 5-11).

5.3.5 Forecast of Economic Benefits, Scenario 3: Slowing Rate of 

Adoption by 67%

In Scenario 3, the rate of adoption was slowed by 67%, which is the equivalent of achieving 

the same level of adoption in 3 years instead of 1 year (Table 5-12). Slowing the rate of 

adoption by 67% is equivalent to allowing for the rate of adoption to take three times as 

long as indicated. Net benefits in this scenario amount of $311.3 million by 2023 instead of 

$333.6 million (Table 5-13). 

5.4 Conclusions

Table 5-14 presents a comparison of the net benefits from each scenario. The principal 

difference in these estimates is the time frame of adoption. Model results suggest that a 

lower-bound range of economic benefit for primary care practices is $311.3 million to 

$333.6 million from implementing 2D barcode scanning because of a reduction in 

documentation time of 58% to 63%.

A number of limitations, apart from benefits that were not quantified, must be kept in mind 

when reviewing these results. First, time savings were based on a time–motion data set and 

not based on actual, routine 2D barcode usage, simply because 2D barcodes for vaccines 

have yet to be introduced. A counterpoint, however, is that the range of time savings 

benefit predicted—36 to 39 seconds per dose—is consistent with the possible 34 seconds 

per dose suggested as possible in Quach et al. (2011). Second, additional benefits that are 

not included in these data are improved inventory management (including reductions in 

inventory-carrying costs and wastage), improved billing through correct product 

identification, and less extraimmunization due to more complete records in IIS. Third, 
 

Chapter 5 

— Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-18

Table 5-10. Scenario 2: Forecast of Barcode Adoption, by Specialty and Size (Number of Practices and Health 

Departments)

Specialty Practice Size

Number 

of 

Practices 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Pediatrics 1–1.5 physicians 1,392 457 916 918 918 918 918 918 918 918 918 918

2–9 physicians 2,582 974 1,961 1,981 1,987 1,987 1,987 1,987 1,987 1,987 1,987 1,987

More than 10 physicians 963 404 807 807 807 807 807 807 807 807 807 807

Total 4,937 1,834 3,684 3,706 3,712 3,712 3,712 3,712 3,712 3,712 3,712 3,712

Family 

practice

1–1.5 physicians 3,146 952 1,914 1,934 1,943 1,943 1,943 1,943 1,943 1,943 1,943 1,943

2–9 physicians 5,173 1,787 3,581 3,598 3,610 3,610 3,610 3,610 3,610 3,610 3,610 3,610

More than 10 physicians 1,243 484 968 968 968 968 968 968 968 968 968 968

Total 9,561 3,224 6,463 6,500 6,521 6,521 6,521 6,521 6,521 6,521 6,521 6,521

Ob-gyn 1–1.5 physicians 1,592 398 796 796 796 796 796 796 796 796 796 796

2–9 physicians 3,481 1,139 2,278 2,278 2,278 2,278 2,278 2,278 2,278 2,278 2,278 2,278

More than 10 physicians 653 237 475 475 475 475 475 475 475 475 475 475

Total 5,725 1,774 3,549 3,549 3,549 3,549 3,549 3,549 3,549 3,549 3,549 3,549

Internal 

medicine

1–1.5 physicians 4,947 1,008 2,016 2,016 2,016 2,016 2,016 2,016 2,016 2,016 2,016 2,016

2–9 physicians 5,197 1,732 3,464 3,464 3,464 3,464 3,464 3,464 3,464 3,464 3,464 3,464

More than 10 physicians 2,318 579 1,159 1,159 1,159 1,159 1,159 1,159 1,159 1,159 1,159 1,159

Total 12,462 3,320 6,639 6,639 6,639 6,639 6,639 6,639 6,639 6,639 6,639 6,639

Total of Identified Specialties 32,685 10,152 20,334 20,393 20,421 20,421 20,421 20,421 20,421 20,421 20,421 20,421

Health Departments 3,669 900 1,814 1,835 1,841 1,841 1,841 1,841 1,841 1,841 1,841 1,841

Note: Sums may not add to totals because of independent rounding. Scenario 2 rate of adoption is the survey respondents’ rate slowed by 

50%. Ultimate penetration estimated to be 75.2% (pediatrics), 68.2% (family practice), 62.0% (ob-gyn), 53.3% (internal medicine), and 

50.2% (health departments). Practice count data are from AMA (2008, 2011) and NACCHO (2010).
 

Chapter 5 

— Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-19

Table 5-11. Scenario 2: Forecast of Net Benefits by Practice and Health Department ($ thousands)

Specialty Practice Size 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Total

Pediatrics 1–1.5 physicians −164 472 1,251 1,263 1,272 1,074 1,082 1,299 1,309 1,318 1,119 11,293

2–9 physicians 182 3,928 7,453 7,577 7,676 6,831 6,875 7,824 7,892 7,952 7,106 71,297

More than 10 physicians −224 5,883 12,111 12,205 12,297 11,283 11,373 12,567 12,656 12,745 11,728 114,625

Total −205 10,284 20,814 21,046 21,245 19,188 19,330 21,690 21,857 22,015 19,953 197,215

Family 

practice

1–1.5 physicians −1,051 −663 688 709 730 63 64 738 753 767 100 2,897

2–9 physicians −2,095 −167 3,633 3,685 3,750 2,080 2,112 3,847 3,891 3,940 2,271 26,947

More than 10 physicians −2,252 −565 3,146 3,178 3,210 1,503 1,535 3,306 3,338 3,370 1,663 21,431

Total −5,398 −1,395 7,467 7,571 7,690 3,646 3,711 7,891 7,981 8,076 4,034 51,274

Ob-gyn 1–1.5 physicians −408 −316 158 160 162 −40 −38 168 170 172 −30 159

2–9 physicians −1,471 −1,172 490 497 503 −275 −268 525 532 539 −239 −340

More than 10 physicians −863 −669 344 349 354 15 19 367 371 376 36 699

Total −2,742 −2,157 992 1,005 1,020 −300 −287 1,060 1,073 1,086 −233 518

Internal 

medicine

1–1.5 physicians −817 −634 322 325 329 8 12 340 343 347 27 602

2–9 physicians −2,580 −1,563 1,810 1,829 1,849 180 200 1,909 1,929 1,949 281 7,793

More than 10 physicians −1,722 −999 1,374 1,391 1,408 846 863 1,461 1,479 1,497 935 8,533

Total −5,119 −3,196 3,506 3,545 3,586 1,034 1,075 3,710 3,751 3,793 1,243 16,928

Total of Identified Specialties −13,464 3,536 32,778 33,168 33,540 23,569 23,829 34,351 34,662 34,971 24,997

Health Departments −865 2,612 6,796 6,929 7,022 5,358 5,400 7,192 7,289 7,372 5,709 60,814

Total −14,329 6,148 39,574 40,097 40,563 28,926 29,229 41,543 41,950 42,343 30,706 326,750

Note: Sums may not add to totals because of independent rounding. Annual scanner operations and maintenance expenses are estimated to 

be 7% of the purchase price of $300 per unit. Scanners are assumed to be replaced at 5-year intervals (i.e., 2018 and 2023). Scenario 2 

rate of adoption is the survey respondents’ rate slowed by 50%. Ultimate penetration estimated to be 75.2% (pediatrics), 68.2% (family 

practice), 62.0% (ob-gyn), 53.3% (internal medicine), and 50.2% (health departments). Practice count data are from AMA (2008, 2011) 

and NACCHO (2010).
 

Chapter 5 

— Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-20

Table 5-12. Scenario 3: Forecast of Barcode Adoption, by Specialty and Size (Number of Practices and Health 

Departments)

Specialty Practice Size

Starting # 

Practices 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Pediatrics 1–1.5 physicians 1,392 305 610 916 918 918 918 918 918 918 918 918

2–9 physicians 2,582 649 1,307 1,970 1,983 1,987 1,987 1,987 1,987 1,987 1,987 1,987

More than 10 

physicians

963 269 538 807 807 807 807 807 807 807 807 807

Total 4,937 1,223 2,456 3,693 3,708 3,712 3,712 3,712 3,712 3,712 3,712 3,712

Family 

practice

1–1.5 physicians 3,146 635 1,276 1,924 1,937 1,943 1,943 1,943 1,943 1,943 1,943 1,943

2–9 physicians 5,173 1,192 2,387 3,590 3,602 3,610 3,610 3,610 3,610 3,610 3,610 3,610

More than 10 

physicians

1,243 323 645 968 968 968 968 968 968 968 968 968

Total 9,561 2,149 4,309 6,482 6,507 6,521 6,521 6,521 6,521 6,521 6,521 6,521

Ob-gyn 1–1.5 physicians 1,592 265 531 796 796 796 796 796 796 796 796 796

2–9 physicians 3,481 759 1,519 2,278 2,278 2,278 2,278 2,278 2,278 2,278 2,278 2,278

More than 10 

physicians

653 158 316 475 475 475 475 475 475 475 475 475

Total 5,725 1,183 2,366 3,549 3,549 3,549 3,549 3,549 3,549 3,549 3,549 3,549

Internal 

medicine

1–1.5 physicians 4,947 672 1,344 2,016 2,016 2,016 2,016 2,016 2,016 2,016 2,016 2,016

2–9 physicians 5,197 1,155 2,310 3,464 3,464 3,464 3,464 3,464 3,464 3,464 3,464 3,464

More than 10 

physicians

2,318 386 773 1,159 1,159 1,159 1,159 1,159 1,159 1,159 1,159 1,159

Total 12,462 2,213 4,426 6,639 6,639 6,639 6,639 6,639 6,639 6,639 6,639 6,639

Total of Identified Specialties 32,685 6,768 13,556 20,363 20,403 20,421 20,421 20,421 20,421 20,421 20,421 20,421

Health Departments 3,669 600 1,209 1,823 1,837 1,841 1,841 1,841 1,841 1,841 1,841 1,841

Note: Sums may not add to totals because of independent rounding. Scenario 2 rate of adoption is the survey respondents’ rate slowed by 

67%. Ultimate penetration was estimated to be 75.2% (pediatrics), 68.2% (family practice), 62.0% (ob-gyn), 53.3% (internal medicine), 

and 50.2% (health departments). Practice count data are from AMA (2008, 2011) and NACCHO (2010).
 

Chapter 5 

— Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-21

Table 5-13. Scenario 3: Forecast of Net Benefits by specialty and size and Health Department ($ thousands)

Specialty Practice Size 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Total

Pediatrics 1–1.5 physicians −94 361 769 1,261 1,272 1,143 1,151 1,161 1,308 1,318 1,188 10,837

2–9 physicians 122 2,619 5,153 7,537 7,638 7,131 7,179 7,230 7,885 7,948 7,406 67,848

More than 10 physicians −149 3,922 8,011 12,205 12,297 11,651 11,741 11,831 12,656 12,745 12,096 109,007

Total −122 6,902 13,933 21,003 21,207 19,925 20,072 20,222 21,850 22,011 20,690 187,692

Family 

practice

1–1.5 physicians −700 −442 −208 703 720 288 291 293 750 762 325 2,782

2–9 physicians −1,397 −111 1,118 3,681 3,728 2,649 2,683 2,715 3,891 3,933 2,840 25,729

More than 10 physicians −1,501 −377 689 3,178 3,210 2,082 2,114 2,147 3,338 3,370 2,243 20,492

Total −3,598 −930 1,599 7,563 7,658 5,019 5,088 5,155 7,979 8,064 5,407 49,003

Ob-gyn 1–1.5 physicians −272 −210 −157 160 162 28 30 32 170 172 38 153

2–9 physicians −980 −782 −615 497 503 −13 −6 1 532 539 23 −301

More than 10 physicians −576 −446 −329 348 353 129 134 138 371 376 151 649

Total −1,828 −1,438 −1,100 1,005 1,018 144 158 171 1,073 1,086 211 500

Internal 

medicine

1–1.5 physicians −544 −423 −314 325 329 116 120 124 343 347 135 559

2–9 physicians −1,720 −1,042 −428 1,829 1,849 743 763 783 1,929 1,949 844 7,499

More than 10 physicians −1,148 −666 −199 1,391 1,408 1,039 1,056 1,075 1,479 1,497 1,129 8,060

Total −3,413 −2,130 −941 3,545 3,586 1,898 1,939 1,982 3,751 3,793 2,107 16,118

Total of Identified Specialties −8,961 2,403 13,490 33,116 33,468 26,988 27,256 27,530 34,653 34,954 28,416

Health Departments −577 1,742 4,059 6,892 7,004 5,936 5,987 6,050 7,275 7,363 6,287 58,017

Total −9,538 4,145 17,549 40,008 40,472 32,923 33,244 33,580 41,928 42,318 34,703 311,330

Note: Sums may not add to totals because of independent rounding. Annual scanner operations and maintenance expenses are estimated to 

be 7% of the purchase price of $300 per unit. Scanners are assumed to be replaced at 5-year intervals. Scenario 3 rate of adoption is the 

survey respondents’ rate slowed by 67%. Ultimate penetration estimated to be 75.2% (pediatrics), 68.2% (family practice), 62.0% (obgyn), 53.3% (internal medicine), and 50.2% (health departments). 
Chapter 5 — Economic Analysis of the Impact of 2D Barcodes on Clinical Documentation

5-22

Table 5-14. Comparison of Net Benefit Forecasts Accruing to Primary Care 

Practices and Health Departments for Three Adoption Scenarios

Year

Net Benefits (Thousand $)

Scenario 1, Rate of 

Adoption Set by Survey

Scenario 2, Rate of 

Adoption Slowed 50%

Scenario 3, Rate of 

Adoption Slowed 67%

2013 −28,659 −14,329 −9,538

2014 39,084 6,148 4,145

2015 39,678 39,574 17,549

2016 40,207 40,097 40,008

2017 40,563 40,563 40,472

2018 16,936 28,926 32,923

2019 41,167 29,229 33,244

2020 41,558 41,543 33,580

2021 41,988 41,950 41,928

2022 42,343 42,343 42,318

2023 18,715 30,706 34,703

Total 333,579 326,750 311,330

Note: Sums may not add to totals because of independent rounding. Annual scanner operations and 

maintenance expenses are estimated to be 7% of the purchase price of $300 per unit. Scanners are 

assumed to be replaced at 5-year intervals. 

adoption curves drive results, particularly for ob-gyn and internal medicine practices. Yet 

recall that we received fewer than 100 responses for each of these two specialties, which 

translates to each response having very large weight. Better survey coverage for pediatric 

and family medicine practices lowered each individual practice’s weight, but there may still 

be issues of regional or population bias that may influence the results, given that not all VFC 

jurisdictions participated in the survey.
 

6-1

6. IMPACT ON EXCHANGE AND MANAGEMENT OF 

IMMUNIZATION INFORMATION 

Because a 2D barcode with Global Trade Item Number (GTIN), lot number, and expiration 

date has yet to be used for vaccine product identification in the United States, it is of 

paramount importance to understand how it will affect exchange and management of 

immunization information. This chapter describes how data from a 2D barcode can populate

electronic health records (EHRs), immunization information systems (IIS), and inventory 

management, billing, and other immunization tracking systems. 

The information systems used by immunization stakeholders are governed by a set of 

standards that help ensure that data are stored in a consistent manner. This consistency, as 

provided by standards, helps enable efficient and accurate data exchange between systems. 

For example, immunization data entered into a provider’s EHR can be transferred to the 

provider’s billing system and to the state IIS. Through interviews and a review of the 

standards, we analyzed how the GTIN, expiration date, and lot number from the 2D barcode 

could be exchanged with other data systems, any associated challenges, and potential 

solutions to overcome those challenges. 

6.1 Methodology for Mapping 2D Barcode Contents Across Data 

Exchange Standards

We reviewed information technology standards that immunization stakeholders commonly 

use, including Health Level 7 (HL7), X12, Healthcare Information Technology Standards 

Panel (HITSP), and National Council for Prescription Drug Program (NCPDP). Standards 

outline data definitions, formats, and representations in information systems to facilitate 

consistent and efficient data exchange and sharing. Because vaccine product information 

will be shared across stakeholders (e.g., manufacturers, providers, public health authorities) 

using different standards for specific transactions, it is necessary to understand how

information would be translated across each standard. The process for developing this 

understanding is referred to as standards mapping.

Standards mapping is critical to provide input to software engineers and information 

architects about potential adjustments to affected information systems. We also sought to 

identify any critical gaps in the standards that would preclude adequate exchange of 2D 

barcoded data. The standards mapping was augmented by interviews to more fully 

understand contextual factors and validate the draft mapping. The balance of this section 

describes methods for standards selection, review, mapping, and validation.

6.1.1 Selection of Standards for Review

Several health care and product standards may be applicable for immunization, including 

barcoding standards (GS1, 2011a), EHR use and messaging (HL7), the Centers for Disease 
Chapter 6 — Impact on Exchange and Management of Immunization Information

6-2

Control and Prevention (CDC) Implementation Guide (CDC, 2011c), Healthcare Information 

Technology Standards Panel (HITSP) (2006), and billing (X12 and NCPDP). Standards for 

review were identified in consultation with technical representatives from GS1 Healthcare 

US, CDC and its contractors, provider organizations, EHR and IIS vendors, and HL7. Table 

6-1 outlines the standards, where they apply, and the relevant systems that use them.

Table 6-1. Standards Reviewed and Their Application

Standard How Used Major Stakeholders Relevant Systems

GS1 Manufacturers to register 

GTINs and print the 2D 

barcodes. Downstream 

systems to read the 

barcode

All All

HL7 EHR 

Functional Model

Information exchange for 

health information 

technology

Vendors, providers, 

registries, CDC

EHR systems, IIS systems, 

practice management 

systems

CDC 2.5.1 

implementation 

guide

Translation of HL7 

standards for provider

community

Vendors, providers, 

registries, CDC

EHR systems, IIS systems, 

practice management 

systems

X12–837P 

transaction (4010 

and 5010)

Providers to submit claims Providers, health 

plans

EHR systems, practice 

management systems, 

payer billing systems

NCPDP (Pharmacy 

EDI)

Pharmacies Pharmacy 

immunizers

Pharmacy systems

HITSP 

immunization 

messaging

Providers, vendors, and 

payers to understand 

immunization messages

Providers, vendors, 

payers

EHR systems, IIS systems, 

practice management 

systems, payer billing 

systems

GS1 (2011a) provided vaccine-specific guidance about expected content and format of the 

2D barcode. This guidance was endorsed by the American Academy of Pediatrics (AAP). As 

discussed in Chapter 1, the GS1 guidance for vaccines includes the GTIN, expiration date, 

and lot number. The GTIN has the National Drug Code (NDC), a universal identifier for 

human drugs, embedded in it. Thus, the placement and formatting of these data elements 

were reviewed across standards.

The HL7 standard is used in a variety of health care contexts, including messaging, EHR 

functions, information exchange, and reporting to an IIS. We reviewed HL7’s EHR Functional 

Model, which details functionality, storage, and messaging for EHRs. However, it is not 

immunization specific. The CDC 2.5.1 implementation guide constrains the HL7 messaging 

specifications for immunization. Thus, we reviewed the standard itself (HL7, 2007) and 

CDC’s guide to translating the messaging aspect of the standard (CDC, 2011d). 
Chapter 6 — Impact on Exchange and Management of Immunization Information

6-3

Claims submission and other health care transactions are governed by a set of electronic 

data interchange (EDI) standards, as per the Health Insurance Portability and Accountability 

Act (HIPAA) (Health Insurance Portability and Accountability Act of 1996, 1996). There are

different structures for various transactions. For example, claims submission has one 

structure, and verifying eligibility has another.1 As per the HIPAA transaction set, the 

specific billing transaction used by providers is called the 837. The 837 claims transaction 

has two components: professional and institutional. Because the majority of vaccines are 

administered by providers, not institutions, the 837 Provider (837P) transaction was 

reviewed. We reviewed both the current 4010 version (ASC X12, 2003) and the upcoming 

5010 version (ASC X12, 2006), which will be operational in January 2012.

Although many vaccines are administered at physicians’ offices, some are administered in 

settings such as pharmacies. Pharmacies conduct transactions using the pharmacy-specific 

NCPDP standard. However, when an authorized immunizer at a retail pharmacy administers 

a vaccine, the individual is not acting as a pharmacy but as an immunization provider. Thus, 

the 837P transaction is used for billing. This is true for pharmacists as well as for nurses and 

others who immunize in the pharmacy setting. Because retail-based pharmacies largely 

conduct pharmacy operations, their systems are set up according to the pharmacy 

standard. Pharmacies translate from the NCPDP standard to the X12 standard prior to 

claims submission. Accordingly, we included the NCPDP standard in the mapping (NCPDP, 

2010a, 2010b). 

We also reviewed the HITSP, which was developed to harmonize and integrate standards. 

Although the panel is not active currently, we reviewed the HITSP Immunization Messaging

documentation because their work is used as an educational guide for implementations 

(HITSP, 2006). 

Thus, the standards reviewed were GS1, HL7, the CDC 2.5.1 implementation guide (which is 

based on HL7), the 837P transaction in both the current and future incarnations, the 

pharmacy EDI standard, and the HITSP immunization messaging guidance.

6.1.2 Standards Review, Mapping, and Mapping Validation

We conducted source-based mapping, which analyzes items from a source document to find 

corresponding items in target documents. Each standard was reviewed to understand how 

the items in the 2D barcode, or the source, would flow across the standards, or the targets. 

This review was done to identify similarities and gaps in data elements across standards and 

to determine the complexity of interoperability. Mapping allows the relationships between 

fields across different standards to be identified.

 

1

Initially, we had planned to review the Eligibility EDI transaction: the X12 guidance for determining 

eligibility of benefits. However, eligibility is not obtained at the vaccine level using the HIPAA 

transactions, so there is no need to map the specific information on the vaccine barcode.
Chapter 6 — Impact on Exchange and Management of Immunization Information

6-4

Our review consisted of taking the GS1 guidance and applying it to the other standards to 

identify placements for the three data elements. First, we reviewed these elements and 

documented their length, format, and definition. Then, we reviewed each standard and 

identified where the elements would be located. The length, format, data type, definition, 

and other identifying information were documented for each field. Throughout mapping, 

notes and examples were documented for further information and reference. In addition to 

the standards themselves, document review included the Food and Drug Administration 

(FDA) guidance (FDA, 2010a) and background material provided by interviewees about their 

organizations.

Once we mapped the standards, we validated the results with the author of the CDC 2.5.1 

implementation guide, who is also a member of HL7, and incorporated his feedback into our 

final results. Validation included determining the appropriate segment of the standard for 

the barcoded information. We also validated the mapping with a pharmacy provider, which 

did not result in any changes. We also attempted validation with X12 provider working 

groups, the Centers for Medicare & Medicaid Services (CMS), EHR vendors, and IIS vendors 

but were unable to secure meaningful feedback.

6.1.3 Interviews with Stakeholder Representatives

We supplemented the standards review with semistructured interviews with stakeholders. 

We interviewed representatives from stakeholder associations Association of Immunization 

Managers (AIM), American Immunization Registry Association (AIRA), American Academy of 

Family Physicians (AAFP), and AAP; 18 out of the 20 IIS that received interoperability 

grants from CDC; IIS software vendors and implementers; physician providers; other 

immunization providers; and EHR vendors. The purpose of the interviews was to understand 

stakeholder perspectives and concerns about modern barcoding of vaccine products. These 

were recorded and transcribed for analysis.

Interviews generally lasted 45 minutes. Many interviewees were unfamiliar with the scope 

of AAP’s 2D barcoding initiative; thus, interviews often began with an educational 

component. Lessons were also gleaned from those with experience in similar areas, such as 

other types of barcoding or different automated input devices (e.g., scanners, weightmeasurement devices, signature pads).

6.2 Standards Mapping Results

Figure 6-1 illustrates a broad overview of the immunization process, stakeholders affected, 

and systems. If a provider uses the barcode when the vaccine is ordered and administered 

at the point of care, some or all manual documentation processes will be replaced by 

automated ones. Rather than writing down or hand-keying into computer systems the 

product number, manufacturer ID, expiration date, lot number, and administration date, 

these data will be noted by scanning a 2D barcode and tying it to other information. For 
Chapter 6 — Impact on Exchange and Management of Immunization Information

6-5

example, the administration date is not included in the label but can be construed from the 

scan date. Similarly, the GTIN does not automatically populate the product and 

manufacturer information, but that information can be extracted from it. Downstream, this 

information will populate a variety of systems such as EHRs, IIS, billing, Vaccine Adverse 

Event Reporting System (VAERS), and other reporting systems. In addition, it will be used 

to pull up reports such as vaccination records for schools.2

The importance of interoperability is emphasized by the number of systems and processes, 

as indicated in Figure 6-1. A variety of different standards and systems are involved at 

different stages in the data flow for immunization. The boxes are color coded by 

stakeholder, and the relevant standards are listed in the figure in a red dotted box.

The balance of this section reviews

 the one-to-many relationship between the GTIN and vaccine product fields in 

different standards,

 the difficulty of parsing the NDC components from NDCs embedded in GTINs, and

 emerging issues associated with using the NDC and legacy codes in information 

systems.

6.2.1 One-to-Many Relationship of GTIN to Vaccine Product Fields

Table 6-2 provides a summary of how different 2D barcode elements will be transmitted 

across standards. The GTIN contains the NDC as a continuous character string. Yet because 

the NDC has three components, and some standards require vaccine product data to be in 

these three discrete segments, the GTIN does not map directly to individual fields across 

standards (FDA, 2011). In other words, there is a one-to-many relationship between the 

GTIN and most data exchange standards’ vaccine product fields.

Unless the NDC can be parsed from the GTIN, a look-up table between the GTIN and a 

segmented NDC code will be required to facilitate electronic data exchange. A look-up table 

will facilitate meeting meaningful use criteria, which specifically cite the CDC 

implementation guide, and IIS reporting requirements.

In contrast to the GTIN, the expiration date and lot number map directly to individual fields 

across standards and, therefore, do not present similar challenges. There is no expiration 

date or lot number information in the X12, HITSP, or pharmacy EDI standards, which is to 

be expected because the expiration date and lot number of a given vaccine are not 

necessary for billing purposes.

 

2

Although the general process is the same for flu, ordering differs because the flu vaccine is often 

ordered seasonally rather than on a just-in-time basis. Thus, flu inventory management does not 

occur relative to inventory review and reconciliation in the same way as it does for vaccines that

are ordered throughout the year. 
6-6

Chapter 6 

— Impact on Exchange and Management of Immunization Information

Figure 6-1. Immunization Processes, Systems, and Standards

PATH OF A VACCINE Billing and Reporting Provider Administration and Documentation Inventory Manufacturer

1. Manufacturer 

labels individual 

vaccine with: 

Product ID; 

Manufacturer ID; 

Lot #; Expiration 

Date

2. Manufacturer 

packages multiple 

vaccines and adds 

secondary label 

with:

Product ID; 

Manufacturer ID; 

Lot #; Expiration 

Date; # of Units

3a. Vaccine delivered 

and stored at 

manufacturer 

warehouse

3b. Vaccine delivered 

and stored at 

McKesson (VFC)

4. Vaccine orders 

delivered to 

providers

5. Provider 

administers 

vaccine

Notes:

-Vaccines are documented at each step of process. 

-Influenza vaccine follows a slightly different path that varies by year.

7. Encounter is billed: 

Product ID; Diagnosis; 

Administration Date

8. Inventory review and 

reconciliation of doses 

billed vs. administered

9a. Order submitted 

to manufacturer

9b. Order submitted 

to state VFC office

6a. Parent/patient provided info: 

Product ID; Administration Date;

Vaccine Information Statement

6b. Information entered into medical 

record: Product ID; Manufacturer ID; 

Lot #; Expiration Date; Administration 

Date

6c. Information to registries: Product 

ID; Manufacturer ID; Lot #; Expiration 

Date; Administration Date

GS1 GS1

GS1

GS1

GS1

HL7

X23 837p

HITSP

CDC 2.5.1

GS1

HL7

X23 837p

HITSP

CDC 2.5.1

HL7

HL7

HL7

GS1

CDC 2.5.1

X12 837p

GS1

HITSP

X12 837p

GS1

HITSP

GS1

CDC 2.5.1

Systems 

Affected

Red box represents the applicable standard 

(continued)
6-7

Chapter 6 — Impact on Exchange and Management of Immunization Information

Figure 6-1. Immunization Processes, Systems, and Standards (continued)
Chapter 6 — Impact on Exchange and Management of Immunization Information

6-8 

Table 6-2. Summary Mapping Tablea, b

GS1

FDA’s National 

Drug Code

HL7—

Barcoding 

Message 

Segment

2.5.1 

Implementation 

Guide

X12—837P 

Transaction

HITSP 

Immunization 

Messages NCPDP

Global 

Trade Item 

Number 

(GTIN)

Label code Administered 

code

Substance 

manufacturer 

name

Labeler code Substance 

manufacturer

Labeler 

code

Product segment Substance 

manufacturer 

name

Administered 

code

Product 

segment

Administered 

code

Product 

segment

Package segment Administered 

barcode 

identifier

Administered 

drug strength 

volume

Package 

segment

Package 

segment

Administered 

drug strength 

volume units

Expiration 

date 

(YYMMDD)

Substance 

expiration date

Substance 

expiration date

Batch or lot 

number

Substance lot 

number

Substance lot 

number

Substance lot 

number

a

The yellow cells denote how the GTIN is mapped, green denotes the expiration date, and orange 

denotes the lot number. Please note that there are two columns for HL7.

b

The NDC within the GTIN is the information source for the other standards.

More detail about the fields listed in Table 6-2, including segment length and location in the 

standard, can be found in Appendix F’s tables.

6.2.2 Review of NDC Construction

At the root of the challenge of mapping GTINs to fields across different standards is the 

construction of the NDC itself. If the NDC segments followed a fixed character length, then a 

decision rule could be written to extract segments of the NDC based on characters’ 

positions. However, the labeler, product, and package segments do not have consistent field 

lengths, precluding the option of writing a decision rule.

The FDA does not issue complete NDC numbers. Rather, the NDC is a combination of three 

segments: labeler code, product code, and package code. Only the labeler code is assigned 

by the FDA. Because each manufacturer is permitted to create product and package codes, 

and the FDA does not require a specific field length for them, it is not possible to write 

automated logic to parse an NDC without delimiters into these three components. The FDA 

(2011) is aware of this issue and includes the following statement on its web site:

Each listed drug product is assigned a unique 10-digit, 3-segment number. This 

number, known as the NDC, identifies the labeler, product, and trade package size. 

The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that 

manufactures (including repackers or relabelers), or distributes (under its own 
Chapter 6 — Impact on Exchange and Management of Immunization Information

6-9 

name) the drug. The second segment, the product code, identifies a specific 

strength, dosage form, and formulation of a drug for a particular firm. Different 

formulations or different strengths of the same formulation should be assigned 

different product codes. This means even if the same formulations of a drug product 

ultimately deliver different strengths of the active ingredient to the recipient, they 

should be assigned different product codes. Also, drug products that share the same 

formulation but have different product characteristics that clearly distinguish one 

drug product version from another cannot share the same product code under the 

same labeler code. The third segment, the package code, identifies package sizes 

and types. Different package codes only differentiate between different quantitative 

and qualitative attributes of the product packaging. Both the product and package 

codes are assigned by the firm. The NDC will be in one of the following 

configurations: 4-4-2, 5-3-2, or 5-4-1.

Based on the above rules, the following character string 1234567809 could refer to three 

hypothetical products, depending on the configuration chosen: 

 12345-678-09

 1234-5678-09

 12345-6780-9 

All of these could be 1234567809 in the NDC segment of the GTIN with no delimiters 

between NDC segments. 

A further complication is that the HIPAA standard is for an 11-digit NDC, not the 10-digit 

NDC used by the FDA. Because of this conflict, many information systems pad the labeler 

code, product code, or package code segments of the NDC with a leading zero instead of an 

asterisk. Thus, a product with a 5-digit labeler code may have a 4-digit product code and a 

2-digit packaging code for some systems.

To resolve this conflict, for its internal use, the FDA uses an asterisk in either a product code 

or a package code. The asterisk simply acts as a placeholder and indicates the configuration 

of the NDC. The FDA does not use zeros as a delimiter because a zero can be a valid digit in 

the NDC. By storing the segments as character data and using the asterisk as a placeholder, 

the FDA eliminates the confusion. In the example, the FDA could store the segments as 

12345-*678-09 for a 5-3-2 configuration or 12345-0678-*9 for a 5-4-1 configuration. 

Because the asterisk is for FDA internal use and the GTIN cannot accommodate special 

characters, there must be another way to identify the three NDC segments.

6.2.3 Review of NDC Position in the GTIN

GS1 does not pad NDCs with zeros, use delimiters, or make any other adjustments. Rather, 

the GS1 standard is to use the 10-digit NDC code free of delimiters. This means that a given 
Chapter 6 — Impact on Exchange and Management of Immunization Information

6-10 

10-character NDC code within the GTIN may not be directly linkable to a single vaccine 

product. GS1 does not support or recommend parsing the GTIN or NDC (when it is 

presented without delimiters); it recommends that these codes be read as a whole and not 

be parsed to reduce the chance of confusion due to variable-length fields and to avoid the 

risk of incorrect parsing. 

GS1 maintains a registry of unique GTINs that refer to only one specific product, and it does 

so by using indicators and the NDC to construct the GTIN. All firms must submit their 

requested GTINs to GS1 to verify that there are no duplicates and to ensure that the GTIN 

is not duplicated in the future.

Figure 6-2 was taken directly from the GS1 (2011a), Draft US Guideline for Application of 

GS1 DataMatrix Barcodes for Vaccines at Point of Care, to illustrate how the NDC is encoded 

within the GTIN. It shows the specific positions of each character:

 Position 1: A one-digit indicator (value from 0 to 8).

 Position 2: Always zero.

 Position 3: Always 3 to indicate that what follows is the NDC number.

 Positions 4 through 13: Always the 10-digit NDC code. The NDC labeler code (with 

the 3 prefix) must be registered with GS1 US to be valid as a GTIN.

 Position 14: Check Digit (a Modulo 10 data check character calculated from the first 

13 digits of the GTIN).

Figure 6-2. National Drug Code (NDC) Embedded in Global Trade Item Number

(GTIN) 

GS1 Company Prefix + Item Reference

Although the length of the GS1 Company Prefix and 

the length of the Item Reference vary, they will 

always be a combined total of 12 digits.

Check Digit

0 0 3 1 2 3 4 5 6 7 8 9 0 6

Position Position 2 – Position 13 Position

GS1 Indicator Digit

Source: GS1 Healthcare US
Chapter 6 — Impact on Exchange and Management of Immunization Information

6-11 

The following example demonstrates how the lack of delimiters would work. The NDC code 

for Fluzone is 49281-0388-15. Table 6-3 shows how it would look if it were scanned by a 

reader.

Table 6-3. Fluzone NDC Embedded in GTIN

Field Indicator

Always 

0 

Always 3 to 

Denote NDC 

is Next 10-digit NDC Code

Check

Digit

Position 

Number

1 2 3 4 5 6 7 8 9 10 11 12 13 14

GTIN 0 0 3 4 9 2 8 1 3 8 8 1 5 x 

As indicated by the table, the 5-4-2 formatting of the NDC code is lost in scanning and the 

NDC would come across as 10-digit ASCII text between positions 4 and 13. Systems that 

rely on the delimited NDC such as the CDC Vaccine Tracking Systems (VTrckS), EHRs, and 

IIS and reporting would require an additional service.

The FDA has procedures in place to ensure that there are no duplicate NDCs (Perkins, 

2012). We also reviewed the NDC structure for all vaccine products in the FDA database as 

of June 15, 2011, to learn how manufacturers constructed their NDC codes. The FDA 

database includes 339 NDCs for vaccine products. Table 6-4 outlines the typical NDC 

structure for major vaccine manufacturers. The asterisk in the column denotes that the 

manufacturer includes an asterisk before the digit for that particular component of the NDC.

6.2.4 Use of NDC, CVX, and MVX in Information Systems

An undercurrent to reviewing the implications of the 2D barcode for standards-based data 

exchange is legacy issues associated with the NDC, CVX, and MVX. Traditionally, the NDC 

has not been used in immunization documentation, reporting, and tracking. Although some 

systems are able to accommodate the NDC, most use CDC’s product identifier (CVX) and 

manufacturer identifier (MVX).

IIS, for example, require the CVX, MVX, and lot number to document an immunization 

(CDC, 2011g). In the future, the NDC will be the cornerstone of inventory control systems

(CDC, 2011a); thus, it is important that techniques be developed to use the NDC code.

Currently, CDC maintains mapping tables between the components of the NDC and the CVX 

and MVX codes (CDC, 2011e), allowing systems to read the NDC and then assign the 

appropriate CVX and MVX codes via a look-up table. The current CDC mapping tables are 

not appropriate for extracting the NDC or its components from the GTIN because they do 

not account for varying field lengths for the three NDC segments. Because GS1 is an
Chapter 6 — Impact on Exchange and Management of Immunization Information

6-12 

international standards organization and the CVX and MVX are codes specific to CDC and 

the United States, they will not be supported by GS1. A mapping table of GTIN to NDC will

be necessary to support GTIN to CVX and MVX. These mapping tables should support all 

vaccine products on the market both on the public side as well as the private-purchase side. 

Table 6-4. NDC Structure for Vaccine Products by Licensee in the FDA Database

Manufacturer or Repackager Labeler Digitsa Product Digitsa Package Digitsa

Berna Biotech Ltd. 5 4 *1

Cardinal Health 5 4 *1

CSL Biotherapies, Inc. 5 *3 2 

Dispensing Solutions, Inc. 5 4 *1

Emergent Biodefense 5 *3 2 

GSK 5 *3 2 

ID Biomedical Corporation 5 *3 2 

Intercell Biomedical, Ltd. 5 *3 2 

Medeva Pharma, Ltd. 5 *3 2 

MedImmune Vaccines, Inc. 5 *3 2 

Merck 5 4 2 

Novartis 5 *3 2 

PD Rx Pharmaceuticals, Inc. 5 *3 2 

Physicians Total Care, Inc. 5 4 *1

Rebel Distributors Corp. 5 *3 2 

Research Foundation 5 *3 2 

Sanofi Pasteur 5 *3 2 

Wyeth 5 4 2 

a

The asterisk denotes that the manufacturer includes an asterisk before the digit for that particular 

component of the NDC. 

6.2.5 Other Considerations

Current vaccine barcoding efforts are occurring simultaneously with efforts to promote 

adoption of EHRs by primary care providers. The benefits of barcoding are predicated on 

providers’ ability to integrate technology use in their practices. The Office of the National 

Coordinator (ONC) recently reported that 80% of hospitals (AHA, 2009) and 41% of officebased physicians (Hsiao et al., 2010) intended to take advantage of incentive programs to 

adopt and demonstrate meaningful use for certified EHRs (ONC, 2011). This effort is 

partially due to federal incentive programs that are funded by the Health Information 

Technology for Economic and Clinical Health (HITECH) Act (HITECH Act, 2009), which was 

enacted as part of American Recovery and Reinvestment Act (ARRA) (Douglas & Larrabee, 
Chapter 6 — Impact on Exchange and Management of Immunization Information

6-13 

2003). This program provides support and incentive payments to be given to eligible 

professionals who demonstrate meaningful use of certified EHRs (ONC, 2011). 

Immunizations are considered part of the meaningful use criteria. Thus, these funding 

streams and incentives are an impetus for increased submission of immunization 

information to IIS.3

Barcoding shows great promise for patient safety and quality. However, barcode standards 

cannot automate all vaccine documentation or solve existing problems. For example, many 

participants in the interviews asked about including Vaccines for Children (VFC) Program 

status in the barcode. Because vaccine products are not identified by funding source at the 

point of manufacture, it is not possible to include that information on the barcode. VFC 

participants were interested in including VFC identifiers in the 2D barcode to facilitate 

requirements for separately managing publicly and privately purchased vaccines. 

Currently, VTrckS has provisions for manual checking of inventory. For Direct VTrckS users, 

updates would need to be made to the system so users can scan the barcode to aid in 

inventory tracking. 

Interview participants cited existing concerns about products with multiple lot numbers, 

such as lyophilized vaccine products and combination vaccines. One example is Pentacel. 

The DTap-IPV is one component and the Hib is the other, each with its own identifier. In the 

antigen-diluent products, a lot number is associated with the antigen and one is associated 

with the diluent, which means there are multiple identifiers and there will be multiple 2D 

barcodes, packages, and numbers. Systems can accommodate one set of information, but

not both. Currently, the practice is to document the antigen’s information and not the 

diluent. It should be decided whether this practice should continue. If it is to continue, the 

practice of documenting only one of the items, and if so which one, should be codified and 

documented in educational materials. Also, methods should be put in place in case the 

incorrect item is scanned so that the incorrect information can be replaced with the 

appropriate information. If this practice is not to continue, then guidance is required 

indicating such. 

Another reason for multiple product identifiers and lot numbers is repackaging, which occurs 

for a small number of vaccines. In this case, the repackager applies its own lot number and 

NDC, as it does for drugs. In this scenario, we expect the manufacturer label to be 

superseded by the repackager label, which is the practice today. This means that the 

repackager would require its own GTIN to generate the barcode. Repackagers are required 

 

3

To help providers with their technology adoption and to meet meaningful use criteria, a system of 

Regional Extension Centers (RECs) was established. Their charge is to support primary care 

clinicians. These RECs are a source of training, guidance, and technical assistance to these 

providers to help them with their implementation efforts from planning through evaluation and 

attestation of meaningful use.
Chapter 6 — Impact on Exchange and Management of Immunization Information

6-14 

to maintain a database of their product identifiers and lot numbers for recall purposes, and 

they will continue to do so. We do not expect that current procedures would change.

6.3 Limitations

Document review, interviews, and limited observations have yielded much information and 

contributed to understanding how the 2D barcode will be implemented. As in all feasibility 

studies, unexpected situations may arise in actual implementation based on unanticipated 

or infrequent data exchange or operational requirements. In addition, note that we 

attempted mapping validation with a variety of stakeholders but not all governmental 

agencies or private firms were able to devote resources to provide this level of detailed 

review. However, we did present the results at a health care informatics conference where a 

variety of stakeholders were present. We also were unable to discuss the project with 

representatives from the FDA or CMS directly. It is possible that representatives from those 

agencies might have insight that could contribute to implementation. To resolve these 

concerns, we worked with representatives from a variety of associations that span the 

immunization process. We also attended the National Immunization Conference (NIC) and 

discussed the effort with participants there to seek multiple perspectives.

6.4 Conclusions

Standards-based data exchange of the GTIN, expiration date, and lot number as captured 

through the 2D barcode has the potential to improve data quality and efficiency when 

documenting vaccine data. Improvement is predicated on a mapping table or other service 

so the GTIN can be mapped to the delimited NDC, CVX, and MVX. Mapping the expected 

GS1 2D barcode standard for vaccine products across the data exchange standards used by 

different stakeholders is a critical first step in implementation. It will help facilitate 

information exchange by outlining where the information in the barcode would fall in each 

standard, providing those who will implement the barcode the specifications necessary to 

accommodate receiving and interpreting the GTIN.

Over the near term, for implementation to be successful, the following will be necessary: 

education and outreach, dissemination of technical specifications and business requirements 

for data exchange, and collaboration with a variety of stakeholders. Accordingly, 

stakeholders such as the CDC, FDA, AAP, GS1, AIM, AIRA, and other provider organizations 

must work in concert. This is of particular importance given the advent of new technologies 

such as updated syringes and radio-frequency identification (RFID). In addition, regulatory 

changes such as serialization and updated meaningful use criteria may bring further 

changes. Thus, setting the foundation for collaboration and information sharing now will 

help with a smooth implementation and update efforts for the 2D barcode.
 

7-1

7. IMPACTS AND IMPLICATIONS FOR OTHER 

STAKEHOLDERS IN THE U.S. IMMUNIZATION 

ECOSYSTEM

Implementing 2D barcoding will likely result in a variety of direct and indirect impacts on 

immunization programs, public health data systems, pharmacies, retail-based clinics

(RBCs), and their associated stakeholders. Here, we review anticipated impacts and 

implications for these parties identified through our literature review and through key 

informant interviews. 

7.1 CDC 317 Immunization Program Grantees 

The 64 grantees of the Centers for Disease Control and Prevention’s (CDC’s) 317 

Immunization Grant Program (317 Program) are responsible for implementing immunization 

programs in 50 states, six cities, and eight current or past territories.1 Their responsibilities 

include public vaccine provision, oversight of provider quality, and IIS support (CDC, 2007). 

Barcoded vaccines can potentially affect aspects of each of these responsibilities: 

 Vaccine provision: Immunization grantees provide vaccines for administration 

through the Vaccines for Children (VFC) Program, as well as state and local 

purchasing mechanisms. Thus, immunization grantees are responsible for vaccine 

management in one way or another. Moreover, immunization program managers 

who participated in key informant interviews asserted that whenever there is a 

concern related to vaccines or their provision, the immunization program manager is 

asked to respond. 2D-barcoded vaccines’ capacity to facilitate vaccine management 

through use of automated product identification promises to benefit immunization 

programs through greater efficiency and accuracy of data. 

 Oversight of provider quality: Immunization grantees’ oversight of provider quality 

includes strategies such as AFIX. AFIX (Assessment Feedback Incentives and 

eXchange) is a quality improvement strategy to improve standards of practice at the 

provider level. 2D-barcoded vaccines’ potential to improve record keeping and data 

exchange offers promising means to improve AFIX. Such improvements could permit 

immunization programs to reallocate resources necessary for AFIX to other 

immunization activities.

 IIS support: IIS have been recognized as a data resource that can facilitate 

achieving immunization surveillance goals (Guide to Community Preventive Services, 

2011). Like other data systems, IIS rely on data population and accuracy for 

success. 2D-barcoded vaccines’ capacity to automate or otherwise improve the 

efficiency and accuracy of data capture will strengthen IIS capacity.

The impact of 2D-barcoded vaccines on IIS is of particular importance given the role IIS

may play in demonstrating meaningful use. One of the criteria for meaningful use payments 

 

1

The six cities are Chicago, the District of Columbia, Houston, New York City, Philadelphia, and San 

Antonio; the eight current or past territories are American Samoa, Federated States of Micronesia, 

Guam, Marshall Islands, Northern Mariana Islands, Palau, Puerto Rico, and the U.S. Virgin Islands.
Chapter 7 — Impacts and Implications for Other Stakeholders in the U.S. Immunization Ecosystem

7-2 

under the American Recovery and Reinvestment Act (ARRA) involves immunization 

messaging. Thus, providers who are implementing electronic health records (EHRs) and are 

anticipating meaningful use are incentivized to submit HL7 messages relaying immunization 

status. 

In an effort to better understand the costs and benefits of 2D-barcoded vaccines on IIS, we 

elicited feedback from members of the Association of Immunization Manager’s (AIM’s) 

immunization registry working group and the American Immunization Registry Association 

(AIRA). AIM represents the 64 managers of CDC’s 317 Immunization Grant Program. Its 

immunization registry working group is composed of immunization program managers with 

particular interest and/or experience related to IIS. AIM convened a discussion with the 

immunization registry working group to discuss costs and benefits of 2D barcodes and the 

implications for registries and immunization programs. Ten program managers also 

responded to a short e-mail request from AIM in May 2011 soliciting input on the following 

questions:

 What are some of the estimated costs associated with integrating barcodes with your 

IIS?

 What do you foresee are the costs associated with implementing barcodes in 

provider offices? 

 What do you foresee are the costs associated with sustaining barcodes in provider 

offices? 

 Do you have any other comments regarding the benefits, challenges, costs, or 

feasibility of barcodes?

7.1.1 Estimated Costs Associated with Integrating 2D Barcodes with IIS

Only two immunization programs offered judgments as to whether they expected the costs 

to outweigh benefits. Most reviewed the issues from their vantage point as program and IIS 

managers. Responding programs anticipate costs to fall within five principal categories:

 IIS modification and enhancement to accommodate acceptance of 2D barcode 

scanner functionalities,

 training of IIS staff,

 ongoing technical assistance from IIS staff to providers, 

 ongoing system maintenance, and

 ensuring all IIS use information and business rules are aligned with barcode 

scanning.
Chapter 7 — Impacts and Implications for Other Stakeholders in the U.S. Immunization Ecosystem

7-3 

Implementation costs would vary depending on preexisting IIS capabilities, but their 

estimates varied significantly because 2D barcode reading had not been costed out yet. 

Some jurisdictions have preexisting capabilities that were developed to support driver’s 

license scanning. The comprehensive cost for one such program was $135,000 with a 10% 

annual maintenance cost, according to a representative. In this particular case, extending 

the features to accommodate reading scanner output and placing the data in the proper 

sequence to fill fields in the IIS may not be significant. 

Some IIS vendors—Scientific Technologies Corporation (STC) and the Wisconsin 

Immunization Registry (WIR) consortium—have more than 20 jurisdictions as customers 

(WIR, 2010; Scientific Technologies Corporation, 2011). Vendors with many customers may 

be able to distribute programming-related costs over multiple jurisdictions, though costs 

related to reviewing and adjusting business rules would likely not be affected by such 

economies of scale. Despite shared platforms, there may still be customization costs for 

making adjustments jurisdiction specific. 

Thus, in essence, the cost for IIS will vary by jurisdiction depending on existing capabilities 

and IIS business and contract models. Although programs were able to provide some 

guidance on expected costs, more detailed investigation into existing functionalities and 

provision of detailed technical specifications for IIS is required to ascertain costs. 

Other costs are possible as well, depending on how barcode usage is rolled out. Some IIS 

staff may need to be trained on how to use scanners and software and may need to review 

EHR/IIS interfaces to support individual practices. IIS may also have to develop a training 

module for delivery to practice staff, which could be about $1,000 if it is an online program, 

according to two IIS. The largest possible cost could be for purchasing scanners, especially 

for highly centralized programs. 

7.1.2 Expected Costs Associated with Implementing and Sustaining 

Barcodes in Provider Offices

Programs anticipate that the following costs could be associated with implementing and 

sustaining barcode use in provider offices:

 purchase of scanners and periodic replacements,

 modification or enhancement of EHRs to accommodate barcode scanning, 

 staff training,

 miscellaneous scanner maintenance costs, and

 maintenance of connections to state IIS or any barcoding-specific software.
Chapter 7 — Impacts and Implications for Other Stakeholders in the U.S. Immunization Ecosystem

7-4 

In addition, they anticipated that there could be costs for software; however, RTI has 

preliminarily determined that most vendors are likely to include 2D barcode reading support 

under their annual licensing agreements. Our model assumes that the scanner purchase 

costs are borne by practices. 

7.1.3 Other Comments Regarding Benefits, Costs, and Feasibility

Program representatives offered perspectives on implementation, costs, benefits, and other 

considerations. They expect there to be challenges getting practices prepared and starting 

to use the barcodes. Concerns include competing priorities for practices, initial costs for 

scanner purchases, training, and installations. Some practices may require substantial 

support and coaching. These representatives also indicated that it is unlikely that public 

programs will be able to provide barcode scanners to practices at no cost.

Once practices have implemented barcode scanning, there may be issues supporting 

ongoing training due to staff turnover and maintenance of devices. Benefits, however, could 

include fewer mistakes in the data from improved record keeping and better vaccine 

inventory management. 2D barcode scanning could be of great use during mass 

immunization clinics. Overall, implicit in their remarks was the importance to review the 

change management process carefully for IIS; ensure that technical specifications are set, 

understood, and communicated; and prepare a training program carefully. 

7.2 American Academy of Pediatrics (AAP), CDC, and National 

Organizations

Whereas the impacts and implications for regional immunization programs are emerging as 

the reality of 2D-barcoded vaccines draws near, activities have occurred at the national 

level to lead, assess, and coordinate the transition from linear to 2D barcodes. The 

activities, and the costs associated with them, represent an allocation of resources that 

must be considered as part of the social cost. Historical and projected cost data were 

provided by AAP and CDC. Although other organizations in the public sector (e.g., GS1, the 

FDA, and various HHS agencies) have been involved in the barcoding initiative, known costs 

as of December 2011 have been largely incurred by AAP and CDC. 

AAP has led and coordinated the vaccine barcoding initiative since 2009, convening 

stakeholders, setting the strategic direction, developing guidance for manufacturers and 

clinicians, and advocating for the initiative at the FDA. AAP has also worked closely with 

GS1 Healthcare US to issue AAP-endorsed technical guidance. AAP also expects to design 

and roll out education programs to support implementation and use of 2D barcodes. 

Resources provided by AAP have averaged about 0.3 to.5 full-time equivalent (FTE) per 

year since 2009, distributed among pediatricians and AAP immunization initiatives 

managers’ time. This level of effort is expected to continue through 2014.
Chapter 7 — Impacts and Implications for Other Stakeholders in the U.S. Immunization Ecosystem

7-5 

CDC has complemented AAP by supporting feasibility studies, technical assessments, and 

analyses of the impacts and implications of using 2D barcodes on standards-based data 

exchange. Costs have included the assignment of personnel to serve as technical monitors 

on this technical feasibility and economics study and personnel to lead and implement a 

pilot and technical assistance program. CDC staffing has been approximately 0.3 FTE for 

2010 and 1.5 FTE for 2011 through 2013. 

AAP and CDC costs for leading the implementation of 2D barcoding for 2009 through 2014 

are estimated to be at least $8.6 million, of which 12% is labor effort expended directly by 

AAP and CDC and 88% is for technical feasibility studies, economic analysis, and 

implementation and technical assistance (Table 7-1).2 Although costs may have been 

incurred by other organizations, these cost data were not available, and it is assumed that 

the majority of costs incurred by national parties have been incurred by AAP and CDC.3

Public-sector costs were not known for 2015 and later years.

Table 7-1. Known AAP and CDC Costs for the Barcoding Initiative

FTEa

Labor Value

($ thousands)

Services

($ thousands)

Total 

($ thousands)

2011 1.80 277 1,560 1,837

2012 1.80 277 3,584 3,860 

2013 1.95 299 2,389 2,688

2014 0.25 33 — 33

Total 1,006 7,624 8,631

a

FTE (full-time equivalent)

7.3 Information Systems Vendors

EHR vendors will also have to make changes to accommodate the barcode. Changes include 

support for the scanners themselves and for integrating scanned data into patients’ records. 

In order for data to be placed in the EHR, an input device, such as a keyboard, is necessary. 

A scanner is another type of input device. In order for the system to recognize it as such, 

some work is necessary to update systems. One vendor noted that the level of effort is 

approximately 40 to 80 hours per product family (products in the same family often share 

component software code). 

 

2

Except for services contract values, CDC and AAP expenditures were provided in FTEs, which we then 

monetized using burdened Bureau of Labor Statistics (BLS) Occupational Employment Statistics 

wage rate data for pediatricians, social scientists and related workers (project managers) in social 

service organizations, and epidemiologists employed by the federal government (BLS, 2011b). 

3

Costs incurred prior to 2011 were treated as sunk costs. All dollar values are in real terms (2010).
Chapter 7 — Impacts and Implications for Other Stakeholders in the U.S. Immunization Ecosystem

7-6 

In addition to the scanner itself, EHRs must accommodate how the data will be used. This 

means that the information that is scanned must be housed in the system and integrated 

with its software. For example, if an EHR has clinical decision support functionality, then it 

can use the scanned data to check against the doctor’s order and to check against best 

practices for immunizations. In addition, the information can be used for reporting such as 

school reports, billing, and inventory. EHRs must be able to recognize the scanned data and 

integrate it with existing functions and software. Because this represents a change in how 

systems will be used, associated training must be provided to end users as well.

IT vendor costs to modify their products are not included in our economic model because it 

is not yet known how many EHR vendor product families would be modified to support 

barcode reading. Although not insignificant, the overall proportion of costs borne by EHR 

vendors would be small compared with other stakeholders’ costs and benefits. At 15 product 

families, and using the 80-hour upper bound of the programming time requirement, the 

cost would be approximately $120,000, assuming a loaded hourly wage rate of $100. 

Further investigation was performed with EHR vendors to inquire about the revenue models 

that may be used to recoup these costs, or if these costs are low enough that they will be 

absorbed under provisions for software updates pushed to licensees. The EHR vendors with 

which we spoke expect that these changes would be included as part of the annual licensing 

agreement and not be a supplemental cost. 

7.3.1 Public Health Agencies

Public health agencies (such as local health departments [LHDs] and immunization 

programs) are responsible for collecting and reporting sizeable amounts of immunization

data for a variety of systems. Thus, the potential for improved efficiency and accuracy in 

data collection associated with 2D barcoding is very appealing. Nevertheless, numerous 

indirect impacts are anticipated when implementing 2D barcoding. The two issues that 

appear most relevant to this discussion are data integration and limited 

resources/technology. 

The challenge of integrating data collection and reporting systems was identified repeatedly 

in the course of key informant interviews, group discussions, and informal communication.

Public health agencies commonly report data to IIS. In our stakeholder interviews, many 

referred to public health agencies as having poor information technology systems and 

capabilities. As a result, what may be challenging in any setting may be particularly daunting 

in settings where technology has not been well integrated. However, the minority of public 

health agencies that are technologically advanced may face more challenges because they 

may have to spend more resources integrating their existing systems with 2D barcodes. 

Related to integrating data systems is the implication of resources. Among the first 

responses from immunization program managers when discussing vaccine barcoding was 
Chapter 7 — Impacts and Implications for Other Stakeholders in the U.S. Immunization Ecosystem

7-7 

“Who’s going to pay for it? Who’s going to deal with providers?” In many areas, public 

health agencies not only provide immunizations, but they are also ultimately responsible for 

managing the overall immunization system. As a result, public health agencies anticipate 

that they may need to provide technical assistance for their use. This is anticipated to be 

especially true for VFC and other providers who rely on public financing.

7.4 Impacts and Implications for Complementary Immunization 

Providers

We define complementary immunization providers as locations, organizations, and 

individuals that provide immunization services that otherwise may be referred to as 

“nontraditional providers.” Examples of such providers include locations such as schools and 

retail stores, organizations such as visiting nurse groups, and professionals such as 

pharmacists. Most of these providers offer immunization services in addition to other 

wellness or clinical services. The Department of Defense’s immunization activities are also 

regarded as complementary providers but are outside the scope of this report.

As mentioned in the literature review in Chapter 2 of this report, there is a paucity of data 

reporting the number or proportion of immunizations administered by a given provider 

and/or in a given location. Based on information from the literature review and the key 

informant interviews, we anticipate that 2D-barcoded vaccines will affect and have 

implications for the vast majority of immunization providers. Based on our understanding of 

the literature included in Chapter 2 of this report and interpretation of key informant 

interviews, providers who are already using electronic data collection are the most likely to 

adopt 2D barcode technologies. Providers who do not use electronic data collection systems 

or who are mobile may be less likely to adopt barcode technologies.

It has been widely observed that increasing numbers of individuals are receiving 

immunizations in nontraditional locations (e.g., retail stores from nontraditional providers 

such as pharmacists [CDC, 2011f]). In Table 7-2, we summarize the characteristics of these 

complementary provider groups and aspects of their practice for which 2D-barcoded 

vaccines may have implications. The characteristics we include are those we anticipate may 

affect the use of 2D barcodes. The rationale is summarized in Table 7-3.

7.4.1 Pharmacies

We expect that pharmacies, especially large chains, will use the 2D barcode. Like their 

counterparts at RBCs, most pharmacies have systems in place for managing inventories and 

for processing documentation electronically (see Chapter 6). 

Although a small sample size, our interviews with two independent pharmacies and one 

large chain suggest that uptake among pharmacy immunizers will be high.
 

Chapter 7 

— Impacts and Implications for Other Stakeholders in the U.S. Immunization Ecosystem

7-8

Table 7-2. Characteristics of Complementary Provider Groups

Complementary Immunization 

Provider and Definition

Characteristics

Fixed 

Location

VFC 

Provider

Use of 

Electronic 

Health 

Records

Use of 

Electronic 

Billing

Current 

Use of 

Barcodes

Use of 

Multidose 

Vial

Health Care 

Personnel 

Vaccinating

Hospitals

Inpatient or outpatient medical 

institution

Yes Sometimes Often Usually Often Variable Physicians

Nurses

Pharmacists

Pharmacies

Independent or chain pharmacy. 

Does not include RBCs that may be 

located within confines of the 

pharmacy 

Yes Sometimes No Often Often Variable Pharmacist

Retail-Based Clinics 

Clinics that offer prescribed limited 

services. May be located within 

larger retail store

Yes No Often Usually Often Variable Nurse or mid-level 

practitioner

Visiting Nurses 

Members of visiting nurses 

association. Primarily provide onsite immunization clinics. Often 

located in settings such as retail 

stores, shopping malls, senior 

centers, or other convenient 

locations

No Sometimes No Often Variable Variable Nurse

Immunization Clinic Providers 

Provide on-site immunization 

clinics. Often located in settings 

such as retail stores, workplaces 

shopping malls, senior centers, or 

other convenient locations 

No Sometimes No Sometimes Variable High Nurse

(continued)
 

Chapter 7 

— Impacts and Implications for Other Stakeholders in the U.S. Immunization Ecosystem

7-9

Table 7-2. Characteristics of Complementary Provider Groups (continued)

Complementary Immunization 

Provider and Definition

Characteristics

Fixed 

Location

VFC 

Provider

Use of 

Electronic 

Health 

Records

Use of 

Electronic 

Billing

Current 

Use of 

Barcodes

Use of 

Multidose 

Vial

Health Care 

Personnel 

Vaccinating

Health Departments/Public 

Clinics 

Considerable variation nationally. In 

some areas, health departments 

provide no direct clinical services; 

in some places, LHDs have 

established immunization clinics

Often Often Occasionally Occasionally Variable Variable Nurse

Travelers’ Clinics (e.g., Passport 

Health)

Provides consultation for 

international travelers and vaccines 

necessary for travel abroad 

(including those recommended for 

nontraveling adults). May provide 

on-site immunization clinics.

Usually No No Sometimes Sometimes Variable Nurse or mid-level 

practitioner
Chapter 7 — Impacts and Implications for Other Stakeholders in the U.S. Immunization Ecosystem

7-10 

Table 7-3. Considerations for Complementary Immunizers

Characteristic Relevance to Barcoded Vaccines

Fixed location Interviewees explained that immunization clinics that were located in a 

fixed geographic location (i.e., a public health clinic) were more likely 

able to have the physical capacity to adopt a new technology such as 

2D scanners than an immunization clinic in a temporary location, such 

as a public library or shopping mall. 

VFC provider VFC providers have established data collection requirements. Given the 

nature of these requirements, many interviewees inferred that any 

means to facilitate the data collection and reporting process such as 2D 

barcodes, would be appealing.

Use of EHRs An EHR is required to fully leverage all the benefits that may result from 

2D-barcoded vaccines. 

Use of electronic billing Data from vaccine barcodes can be uploaded to electronic billing 

systems.

Health care personnel 

vaccinating

In addition to the labor cost-related implications, there are also 

implications related to the type of training that would be required for 

different personnel to implement barcode technology.

As an example, for the flu campaign through March 2011, the retail pharmacy chain 

Walgreens administered 6.4 million flu shots (Walgreens, 2011). Assuming a documentation 

benefit of 30 seconds per dose and a fully loaded wage rate of $75.15 for a pharmacist 

(BLS, 2011b), time savings could have amounted to more than $4 million for this one 

organization alone, excluding any one-time adoption costs.

7.4.2 Retail-Based Clinics 

RBCs are free-standing or located in pharmacies or large retail stores. RBCs are most often 

staffed by nurse practitioners or physician assistants who provide preventative services (like 

immunizations) and diagnosis and treatment of limited acute conditions. The Convenient 

Care Association (CCA) estimates that there are 1,200 RBCs located within 34 states. CCA 

represents 90% of RBCs, such as Target’s Target Clinics, CVS Minute Clinics, and

Walgreens’ Take Care Clinics. A 2008 study reported that 19.7% of the 1.35 million RBC 

visits were for immunization services (Mehrotra, Wang, Lave, Adams, & McGlynn, 2008), 

and it appears that the role of RBCs as a source of health care will grow (Marketwire, 2011). 

RBCs’ business model focuses on providing health care services that are high quality and 

low cost. Because RBCs are businesses, they are located where there is sufficient population 

to yield economic self-sufficiency; 88% of RBCs are located within a major metropolitan 

area (Pollack & Armstrong, 2009). CCA’s membership guidelines include the use of EHRs 

and similar mechanisms whose efficiency promotes the business model of high quality and 

low cost. Given this, we anticipate that RBCs will likely adopt 2D barcodes. We anticipate 

that RBCs will face challenges when integrating barcoding into existing data systems, but 

that overall the anticipated long-term benefits from improved efficiency will outweigh the 
Chapter 7 — Impacts and Implications for Other Stakeholders in the U.S. Immunization Ecosystem

7-11 

short-term challenges of integrating the technology into existing systems. CCA believes that 

RBCs will adopt use of 2D barcodes. 

7.4.3 Other Complementary Immunizers

Complementary immunizers such as visiting nurse groups may operate in a variety of 

locations, including senior centers, libraries, shopping centers, places of worship, and 

businesses. This variety and mobility means that there are logistical considerations that

immunization providers in fixed locations do not face. For example, community immunizers 

must spend a considerable amount of time and resources simply moving supplies—including 

large insulated coolers that are required to maintain the cold chain. These logistical 

challenges mean that community immunizers are reluctant to bring with them any object 

that is more than they think is essential to providing immunizations (Personal interview with 

Steve Pellito, Maxim Health, January 7, 2011). Although most will directly bill Medicare, 

many operate primarily on a cash basis. In keeping with efforts to reduce paperwork and 

any activities beyond providing vaccination, stakeholders interviewed reported that many 

such immunizers may not report immunizations to IIS or other data systems. Thus, the 

potential benefits associated with implementing barcode technologies are less appealing to 

some community immunizers. Community immunizers with whom we spoke reported that 

they were unlikely to adopt 2D barcode technology. 

7.5 Limitations

0ur assessment of the impact of 2D-barcoded vaccines on immunization stakeholders is 

limited because of the complexities of the U.S. immunization system. These complexities 

result in the limitations of the quantity and specificity of the information on which our 

assessment is based. In collaboration with CDC, we limited our focus to primary care 

physicians, who provide the majority of immunizations (pediatricians, family physicians, 

internal medicine physicians, and obstetricians-gynecologists [ob-gyns]) and 

complementary immunization providers (including public health agencies, community 

immunizers, RBCs, and pharmacists). Physicians and LHDs were surveyed; key informant 

interviews were conducted with those representing complementary immunization providers 

(visiting nurses associations, on-site immunization clinic providers, a large chain pharmacy, 

and RBCs). Despite focusing our assessment on these groups, the paucity of specific data 

reporting how many vaccinations are administered by which stakeholder group means that 

in many cases we can only suggest the relative impact of a given stakeholder group.

7.6 Summary

The impact of 2D-barcoded vaccines on immunization stakeholders varies according to the 

immunization provider and the location in which immunization services are provided. The 

success of implementing vaccine barcode technology depends on immunization providers 

integrating 2D-barcode scanning technology into current immunization practice. Providers 
Chapter 7 — Impacts and Implications for Other Stakeholders in the U.S. Immunization Ecosystem

7-12 

who are already using electronic systems for data collection and reporting are also 

anticipated to embrace 2D-barcoded vaccine technologies. For pharmacies and RBCs who 

already use electronic systems for tracking products (like pharmacies) or EHRs (like RBCs), 

the efficiency of using an electronic scanner to upload data is recognized as a means to 

reduce their costs. Providers who do not rely on electronic data collection and reporting 

systems are less likely to take advantage of 2D-barcoded vaccines. 

LHDs have limited resources for acquiring or implementing new technologies. Although 

LHDs are generally eager to collect and report public health data, like other public agencies, 

LHDs are facing daunting economic challenges. As much as local health officials may 

recognize and aspire to achieve the potential benefits associated with 2D-barcoded 

vaccines, implementation of such technologies will likely be a considerable challenge. 

Although IIS will face costs associated with integrating data uploaded from barcoded 

vaccines, costs are outweighed by the anticipated benefits associated with IIS, which are 

populated with better-quality data.

Complementary immunization providers that are focused solely on administering vaccines, 

such as community immunizers who provide mobile vaccination clinics, appear to be less 

interested in implementing 2D barcode technologies. For these immunizers, the costs of

implementation are seen as too great to make it worthwhile to change existing 

immunization and administrative practices.

In addition to considering the costs associated with different stakeholders’ implementation 

of 2D barcode technologies, one must also recognize the differences in practice settings. In 

other words, one must consider not just the provider, but the practice as well. These 

differences influence aspects such as approaches to training, number of scanners required, 

and the costs associated with integrating barcode scanners into existing data collection 

systems. When considering the integration of 2D barcodes into immunization practice, 

consideration should be made regarding how hardware and software integrate with existing 

systems. Although stakeholders who already have EHRs and electronic data systems seem 

poised to readily adopt barcoded vaccines, integrating these new technologies into existing 

systems may, in fact, be as challenging (or even more so) for these stakeholders than for 

those without existing systems, and they may have to start from scratch.
 

8-1

8. SUMMARY RESULTS AND CONCLUSIONS

This summary chapter presents lower-bound economic impact results and several

recommendations in light of the pending implementation of 2D barcodes for vials, syringes, 

and other primary packaging in the United States. We forecast between $326.3 and $348.5 

million in net economic benefits between 2011 and 2023, including all known costs for 

manufacturers, provider adoption costs, and benefits from more efficient documentation. 

We were unable to monetize all expected economic benefits. Rather than make a series of 

assumptions about reductions in extraimmunization, more efficient inventory management, 

and improved immunization surveillance and product recall, economic benefits associated 

with saving time during record keeping alone were used in the comparison with economic 

costs incurred by manufacturers, providers, and public-sector stakeholders. In contrast to 

benefits, economic costs were well defined. That the benefit-to-cost ratio (BCR) ranged 

between 2.7 to 2.8 under three adoption-rate scenarios indicates that even though this 

analysis took a conservative approach, implementation of 2D barcodes on primary 

packaging labels is socially optimal. 

Economic benefits for reduced extraimmunization and improved immunization surveillance 

and product recall are, in part, predicated on the ability of immunization data to be 

populated within immunization information system (IIS), electronic health records (EHRs), 

practice management systems, and other software systems. Early in this study, we 

established as a focus reviews of data exchange standards to analyze how the data 

embedded within 2D barcodes would be translated across different standards and 

exchanged across different systems. It became apparent that there is a one-to-many 

relationship between a Global Trade Item Number (GTIN) in which the National Drug Code 

(NDC) is embedded and various standards’ data fields for labeler, product, and packaging 

codes. In essence, whereas the GTIN contains items in one continuous string, other 

standards are structured to receive the delimited components of that string. 

A recommendation we have for the Centers for Disease Control and Prevention (CDC), 

which is responsible for the immunization data exchange aspects under Health Level 7 

(HL7), is to support and maintain a mapping of GTIN, NDC, MVX+CVX, and Current 

Procedural Terminology (CPT) to ensure that all stakeholders in the information systems 

ecosystem have access to accurate mapping tables that will be maintained consistently over

time. 

Our rationale for CDC maintaining the mapping is because CDC currently is responsible for 

HL7 implementation for immunization data exchange, and our recommendation extends 

current responsibilities rather than establishing new ones. We also believe that public-sector 

provision of the mapping, which would be an infratechnology, would be more cost-effective 
Chapter 8 — Summary Results and Conclusions

8-2 

than individual private companies developing and maintaining their own mapping. It also 

avoids risks associated with out-of-date mappings or organizations ceasing to support 

mappings, among others.

8.1 Summary Economic Impacts

Economic impacts were quantified prospectively for vaccine manufacturers, primary care 

providers, local health departments (LHDs), and public-sector stakeholders American 

Academy of Pediatrics (AAP) and CDC. We combined the economic benefits quantified under 

this analysis into the time series presented in Table 8-1. 

Table 8-1. Comparison of Forecast of Quantified Net Benefits for Vaccine 

Manufacturers, Primary Care Providers, Health Departments, and 

Public-Sector Organizations

Year

Net Benefits (Million $)

Scenario 1, Rate of 

Adoption Set by Survey

Scenario 2, Rate of 

Adoption Slowed 50%

Scenario 3, Rate of 

Adoption Slowed 67%

2011 −9.60 −9.60 −9.60

2012 −19.16 −19.16 −19.16

2013 −36.55 −22.22 −17.43

2014 44.00 11.06 9.06 

2015 44.67 44.57 22.54 

2016 45.25 45.14 45.05 

2017 45.65 45.65 45.56 

2018 22.07 34.06 38.06 

2019 46.36 34.42 38.43 

2020 46.79 46.78 38.82 

2021 47.27 47.24 47.21 

2022 47.68 47.68 47.65 

2023 24.10 36.09 40.09 

Total 348.53 341.71 326.29 

Note: Dips in benefits in 2018 and 2023 are associated with scanner replacement at the end of their 

estimated 5-year useful life. Annual scanner operations and maintenance expenses are estimated to 

be 7% of the purchase price of $300 per unit. Scanners are assumed to be replaced at 5-year 

intervals. Sums may not add to totals because of independent rounding.

We quantified costs for manufacturers, primary care and LHD providers, CDC, and AAP, but 

we present the benefits net of adoption costs from more efficient record keeping for 

immunizers under three scenarios. Because we included all known costs in the analysis, but 

only included quantified economic benefits for documenting immunization, the results are a 

lower-bound estimate. Benefits from improved inventory management and reductions in 
Chapter 8 — Summary Results and Conclusions

8-3 

extraimmunization are expected but were unable to be quantified at this time. The scenarios 

present a range of expected benefits because, although we expect practices to follow their 

stated preferences to use 2D barcodes, it is possible that they may not be able to follow 

their preference for when to do so. Therefore, we allowed the accrual of economic benefits 

to slow by 50% and by 67%, under the possibility that providers may take 2 to 3 times as 

long to begin using the barcodes.

When modeled at survey respondents’ expected rate of adoption, total economic benefits 

are $348.5 million through 2023.1 Despite slowing respondents’ expected adoption by 50% 

and again by 67% in two alternative scenarios, net benefits remain positive. 

8.1.1 Distribution of Quantified Economic Benefits and Costs among 

Stakeholders

Tables 8-2 through 8-4 present summary economic impacts by major stakeholder groups. 

At present, manufacturer, provider, and public-sector costs are fairly well defined. What this 

series of tables permits is a depiction of how different adoption rates for providers affect the 

accrual of economic benefits. 

Table 8-2. Scenario 1: Forecast of Economic Benefits and Costs by Stakeholder, 

Rate of Adoption Set by Survey Results ($ Million)

Providers Manufacturers

PublicSector 

Costs

Net 

Year Costs Benefits Benefits

Net 

Benefits Costs Benefits

Net 

Benefits

2011 7.65 −7.65 1.95 −9.60

2012 15.30 −15.30 3.86 −19.16

2013 48.87 20.21 −28.66 7.65 2.45 −5.20 2.69 −36.55

2014 1.85 40.93 39.08 4.94 4.94 0.03 44.00 

2015 1.81 41.49 39.68 4.99 4.99 44.67 

2016 1.69 41.90 40.21 5.04 5.04 45.25 

2017 1.69 42.25 40.56 5.09 5.09 45.65 

2018 25.67 42.61 16.94 5.14 5.14 22.07 

2019 1.80 42.96 41.17 5.19 5.19 46.36 

2020 1.77 43.32 41.56 5.24 5.24 46.79 

2021 1.69 43.68 41.99 5.29 5.29 47.27 

2022 1.69 44.03 42.34 5.33 5.33 47.68 

2023 25.67 44.39 18.72 5.38 5.38 24.10 

Total 114.20 447.78 333.58 30.60 54.08 23.48 8.53 348.53 

Note: Occasional decreases in net benefits for providers are associated with scanner replacement at 

the end of their estimated 5-year useful life. Sums may not add to totals because of independent 

rounding.

 

1

Note all dollar values are presented in real terms (2010).
Chapter 8 — Summary Results and Conclusions

8-4 

Table 8-3. Scenario 2: Forecast of Economic Benefits and Costs by Stakeholder, 

Rate of Adoption Slowed by 50% ($ Million)

Providers Manufacturers PublicSector 

Costs

Net 

Year Costs Benefits Benefits

Net 

Benefits Costs Benefits

Net 

Benefits

2011 — — — 7.65 — −7.65 1.95 −9.60

2012 — — — 15.30 — −15.30 3.86 −19.16

2013 24.44 10.11 −14.33 7.65 2.45 −5.20 2.69 −22.22

2014 24.52 30.67 6.15 4.94 4.94 0.03 11.06

2015 1.83 41.40 39.57 4.99 4.99 44.57

2016 1.75 41.85 40.10 5.04 5.04 45.14

2017 1.69 42.25 40.56 5.09 5.09 45.65

2018 13.68 42.61 28.93 5.14 5.14 34.06

2019 13.73 42.96 29.23 5.19 5.19 34.42

2020 1.78 43.32 41.54 5.24 5.24 46.78

2021 1.73 43.68 41.95 5.29 5.29 47.24

2022 1.69 44.03 42.34 5.33 5.33 47.68

2023 13.68 44.39 30.71 5.38 5.38 36.09

Total 100.53 427.28 326.75 30.60 54.08 23.48 8.53 341.71

Note: Occasional decreases in net benefits for providers are associated with scanner replacement at 

the end of their estimated 5-year useful life. Sums may not add to totals because of independent 

rounding.

Table 8-4. Scenario 3: Forecast of Economic Benefits and Costs by Stakeholder, 

Rate of Adoption Slowed by 67% ($ Million)

Providers Manufacturers

PublicSector 

Costs

Net 

Year Costs Benefits Benefits

Net 

Benefits Costs Benefits

Net 

Benefits

2011 — — — 7.65 — −7.65 1.95 −9.60

2012 — — — 15.30 — −15.30 3.86 −19.16

2013 16.29 6.75 −9.54 7.65 2.45 −5.20 2.69 −17.43

2014 16.35 20.49 4.14 4.94 4.94 0.03 9.06

2015 16.95 34.50 17.55 4.99 4.99 22.54

2016 1.78 41.79 40.01 5.04 5.04 45.05

2017 1.73 42.20 40.47 5.09 5.09 45.56

2018 9.69 42.61 32.92 5.14 5.14 38.06

2019 9.72 42.96 33.24 5.19 5.19 38.43

2020 9.75 43.32 33.58 5.24 5.24 38.82

2021 1.75 43.68 41.93 5.29 5.29 47.21

2022 1.72 44.03 42.32 5.33 5.33 47.65

2023 9.69 44.39 34.70 5.38 5.38 40.09

Total 95.40 406.73 311.33 30.60 54.08 23.48 8.53 326.29

Note: Occasional decreases in net benefits for providers are associated with scanner replacement at 

the end of their estimated 5-year useful life. Sums may not add to totals because of independent 

rounding.
Chapter 8 — Summary Results and Conclusions

8-5 

8.1.2 Measures of Economic Return

We calculated a series of performance measures on the time series of benefits and costs. 

These measures led us to conclude that transitioning to 2D barcoding for vaccine product 

labels will have a benefit-to-cost ratio of 2.7 to 2.8 (Table 8-5); in other words, for every $1 

expended, $2.70 to $2.80 in benefits are expected to accrue over the period from 2011 

through 2023.

Table 8-5. Summary Measures of Economic Return, based on Forecast of 

Quantified Net Benefits for Vaccine Manufacturers, Primary Care 

Providers, Health Departments, and Public-Sector Organizations

Measure, 2011–2023 Only

Scenario 1, 

Rate of 

Adoption Set 

by Survey

Scenario 2, 

Rate of 

Adoption 

Slowed 50%

Scenario 3, 

Rate of 

Adoption 

Slowed 67%

Total benefits (million $) 501.87 481.36 460.82

Total costs (million $) 153.33 139.66 134.53

Total net benefits (million $) 348.53 341.71 326.29

Net present value (3% discount rate) (million $) 271.49 263.37 249.41

Net present value (7% discount rate) (million $) 196.81 188.10 175.97

Benefit-cost ratio (undiscounted) 3.3 3.4 3.4

Benefit-cost ratio (3% discount rate) 3.0 3.1 3.1

Benefit-cost ratio (7% discount rate) 2.7 2.8 2.7

Internal rate of return 49% 46% 43%

Note: Ultimate penetration estimated to be 75.2% (pediatrics), 68.2% (family practice), 62.0% (obgyn), 53.3% (internal medicine), and 50.2% (health departments). 

8.1.3 Sensitivity Analysis

In essence, our inclusion of two additional adoption scenarios represents a sensitivity 

analysis. However, because this economic analysis is a prospective one, three additional 

model runs were performed:

 lower-bound time savings from use of barcodes, in which the lower bound of the 

95% confidence interval (CI) for time savings was used to quantify economic 

benefits rather than the mean;

 upper-bound time savings from use of barcodes, in which the upper bound of the 

95% CI for time savings was used to quantify economic benefits; and

 eliminating internal medicine and obstetric-gynecology (ob-gyn) practices as 2D 

barcode users because our model projections are relying on only 58 internal 

medicine respondents and 100 ob-gyn responses to represent their specialties.
Chapter 8 — Summary Results and Conclusions

8-6 

Table 8-6 presents the results of sensitivity analyses using upper- and lower-bound time–

motion study results. Time–motion savings are estimated to be 36.5s/dose (95% CI: 32.3–

40.5) to 39.4s/dose (95% CI: 34.8–43.9), depending on EHR usage. The benefit-cost ratio 

(BCR) (7% social discount rate) when the lower-bound time–motion savings result is used is 

2.4 to 2.5, and 3.0 when the upper-bound estimate is used. This compares with our analysis 

results of 2.7 to 2.8. Results raise or lower by 7 to 16%.

Time–motion estimates are not the greatest source of uncertainty, however. The greatest 

source is related to low response rates from internal medicine and ob-gyn practices. 

Therefore, we analyzed measures of economic return under the assumption that these 

practices do not use the barcode. The results of using the mean and upper-bound time 

motion savings without medicine and ob-gyn practices are depicted in Table 8-7. Because 

the ratio of benefits and costs is low for these two specialties (as they are low volume 

immunizers), their removal actually has the effect of increasing the BCR. Sensitivity analysis 

results for mean time–motion savings estimate excluding internal medicine and ob-gyn 

practices are recommended for use in peer-reviewed publications because of the low 

number of survey responses from internal medicine and ob-gyn practices.

We also ran a pessimistic scenario in which we excluded all ob-gyn and internal medicine 

practices, reduced adoption by pediatric and family medicine practices and health 

departments by 25%, and doubled workflow redesign and training costs.

8.2 Recommendations for Implementation

A key focus in our analysis was on data exchange standards. Although data exchange 

standards can accommodate the 2D barcode, implementation of 2D barcoding for vaccine 

products will require a comprehensive mapping of the GTIN to the delimited NDC to the CVX 

and MVX. Including CPT codes would facilitate billing; thus, it would be advantageous to 

include them in the mapping table. Programming efforts, education, and coordination with 

stakeholders are needed to use 2D barcodes across immunization encounter, inventory, 

billing, and other tracking systems used for immunization. Specific recommendations follow 

(see also Table 8-8).

8.2.1 Mapping Tables of GTIN to NDC to CVX and MVX

Because GS1 does not support parsing the GTIN and elements of the NDC embedded in it 

are required for vaccine identification, an additional service is needed to use the 2D 

barcode. One possibility is a look-up table for GTIN to NDC to the CVX and MVX and to CPT 

for both public and private purchasers. This is similar to CDC’s current mapping of NDC to 

the CVX and MVX. CDC provides tables mapping the NDC to the CVX and MVX based on the 

FDA’s NDC Directory (CDC, 2011e). These mapping tables could be augmented or additional 

ones created to allow for complete GTINs to be mapped to the CVX and MVX. The tables 
 

Chapter 8 

— Summary Results and Conclusions

8-7

Table 8-6. Sensitivity Analyses Using Upper- and Lower-Bound Time–Motion Savings Results 

Mean Results Lower-Bound Time–Motion Savings Upper-Bound Time–Motion Savings

Measure, 2011–2023 Only

Rate of 

Adoption Set 

by Survey 

Results

Rate of 

Adoption 

Slowed by 

50%

Rate of 

Adoption 

Slowed by 

67%

Rate of 

Adoption Set 

by Survey 

Results (% 

Change from 

Mean)

Rate of 

Adoption 

Slowed by 

50%(% 

Change from 

Mean)

Rate of 

Adoption 

Slowed by 

67%(% 

Change from 

Mean)

Rate of 

Adoption Set 

by Survey 

Results(% 

Change from 

Mean)

Rate of 

Adoption 

Slowed by 

50%(% 

Change from 

Mean)

Rate of 

Adoption 

Slowed by 

67%(% 

Change from 

Mean)

Total benefits (million $) 501.87 481.36 460.82 449.86

(−10.4%)

431.74

(−10.3%)

413.58

(−10.4%)

552.73

(+10.1%) 

529.90

(+10.1%

507.02

(+10.0%

Total costs (million $) 153.33 139.66 134.53 153.33

(n/c)

139.66

(n/c)

134.53

(n/c)

153.33

(n/c)

139.66

(n/c)

134.53

(n/c)

Total net benefits (million $) 348.53 341.71 326.29 296.53

(−14.9%)

292.08

(−14.5%)

279.05

(−14.5%)

399.40

(+14.6%)

390.24

(+14.2%)

372.49

(+14.2%)

Net present value

(3% discount rate) (million $)

271.49 263.37 249.41 229.44

(−15.5%)

223.52

(−15.1%) 

211.74

(−15.2%) 

312.63

(+15.2%) 

302.34

(+14.8%)

286.26

(+14.8%)

Net present value

(7% discount rate) (million $)

196.81 188.10 175.97 164.44

(−16.4%) 

157.74

(−16.1%) 

147.53

(−16.2%) 

228.47

(+16.1%)

217.79

(+15.8%) 

203.78

(+15.8%)

Benefit-cost ratio (undiscounted) 3.3 3.4 3.4 2.9

(−12.1%)

3.1

(−8.8%)

3.1

(−8.8%)

3.6

(+9.1%)

3.8

(+11.8%) 

3.8

(+11.8%)

Benefit-cost ratio 

(3% discount rate)

3.0 3.1 3.1 2.7

(−10.0%)

2.8

(−9.7%)

2.8

(−9.7%)

3.3

(+10.0%)

3.5

(+12.1%) 

3.4

(+9.7%) 

Benefit-cost ratio 

(7% discount rate)

2.7 2.8 2.7 2.4

(−11.1%) 

2.5

(−10.7%) 

2.4

(−11.1%) 

3.0

(+11.1%)

3.0

(+7.1%) 

3.0

(+11.1%) 

Internal rate of return 49% 46% 43% 43%

(−12.2%) 

41%

(−10.9%) 

38%

(−11.6%) 

55%

(+12.2%) 

50%

(+8.7%) 

47%

(+9.3%) 
8-8

Chapter 8 

— Summary Results and Conclusions

Table 8-7. Sensitivity Analyses Using Upper- and Lower-Bound Time–Motion Savings Results and Including 

Pediatric, Family Medicine, and Health Department Practices Only

Main Results

Mean Time–Motion Savings 

Estimate Excluding Internal 

Medicine and Ob-gyn Practices 

Pessimistic Scenario:

Lower-Bound Time–Motion 

Savings Estimate, Excluding 

Internal Medicine and Ob-gyn 

Practices, Reducing Endpoint 

Adoption by 25%, and Doubling 

Workflow Redesign and Training 

Costs

Upper-Bound Time–Motion 

Savings, Excluding Internal 

Medicine and Ob-gyn Practices

Measure, 2011–2023 

Only

Rate of 

Adoption 

Set by 

Survey 

Results

Rate of 

Adoption 

Slowed by 

50%

Rate of 

Adoption 

Slowed by 

67%

Rate of 

Adoption 

Set by 

Survey 

Results 

(%

Change)

Rate of 

Adoption 

Slowed by 

50% (%

Change)

Rate of 

Adoption 

Slowed by 

67% (%

Change)

Rate of 

Adoption 

Set by 

Survey 

Results 

(%

Change)

Rate of 

Adoption 

Slowed by 

50% (%

Change)

Rate of 

Adoption 

Slowed by 

67% (%

Change)

Rate of 

Adoption 

Set by 

Survey 

Results 

(%

Change)

Rate of 

Adoption 

Slowed by 

50% 

(%Chang

e)

Rate of 

Adoption 

Slowed by 

67% 

(%Chang

e)

Total benefits (million $) 501.87 481.36 460.82 447.02

(−12.3%)

429.00

(−12.2%)

410.96

(−12.1%)

401.39

(−25.0%)

385.46

(−24.9%)

369.52

(−24.7%)

491.66

(−2.1%)

471.59

(−2.1%)

451.50

(−2.1%)

Total costs (million $) 153.33 139.66 134.53 113.95

(−34.6%)

95.41

(−46.4%)

101.30

(−32.8%)

105.39

(−45.5%)

98.49

(−48.1%)

95.90

(−40.3%)

113.95

(−34.6%)

104.74

(−33.3%)

101.30

(−32.8%)

Total net benefits (million 

$)

348.53 341.71 326.29 333.08

(−4.6%)

333.59

(−2.4%)

309.67

(−5.4%)

296.00

(−17.7%)

286.97

(−19.1%)

273.62

(−19.2%)

377.71

(7.7%)

366.85

(6.9%)

350.21

(6.8%)

Net present value (3% 

discount rate) (million $)

271.49 263.37 249.41 260.62

(−4.2%)

258.85

(−1.7%)

237.95

(−4.8%)

229.88

(−18.1%)

220.72

(−19.3%)

208.71

(−19.5%)

296.71

(8.5%)

285.40

(7.7%)

270.28

(7.7%)

Net present value (7% 

discount rate) (million $)

196.81 188.10 175.97 190.34

(−3.4%)

186.87

(−0.7%)

169.24

(−4.0%)

165.91

(−18.6%)

157.06

(−19.8%)

146.67

(−20.0%)

218.13

(9.8%)

206.91

(9.1%)

193.64

(9.1%)

Benefit-cost ratio 

(undiscounted)

3.3 3.4 3.4 3.9

(15.4%)

4.5

(24.4%)

4.1

(17.1%)

3.8

(13.2%)

3.9

(12.8%)

3.9

(12.8%)

4.3

(23.3%)

4.5

(24.4%)

4.5

(24.4%)

Benefit-cost ratio (3% 

discount rate)

3.0 3.1 3.1 3.6

(16.7%)

4.0

(22.5%)

3.6

(13.9%)

3.4

(11.8%)

3.5

(11.4%)

3.4

(8.8%)

3.9

(23.1%)

4.0

(22.5%)

4.0

(22.5%)

Benefit-cost ratio (7% 

discount rate)

2.7 2.8 2.7 3.2

(15.6%)

3.5

(20.0)

3.1

(12.9)

3.0

(10.0%)

3.0

(6.7%)

2.9

(6.9%)

3.5

(22.9%)

3.5

(20.0%)

3.4

(20.6%)

Internal rate of return 49% 46% 43% 53%

(7.5%)

50%

(8.0%)

45%

(4.4%)

47%

(−4.3%)

43%

(−7.0%)

40%

(−7.5%)

59%

(16.9%)

53%

(13.2%)

49%

(12.2%)

Note: Sensitivity analysis results for mean time–motion savings estimate excluding internal medicine and ob-gyn practices are recommended for use in peer-reviewed publications 

because of the low number of survey responses from internal medicine and ob-gyn practices.
Chapter 8 — Summary Results and Conclusions

8-9 

Table 8-8. Summary of Recommendations

Recommendation Rationale

Maintain GTIN to NDC to CVX 

and MVX mapping table

Enable legacy systems to be populated with 2D-barcoded data; 

support data exchange and interoperability.

Collaborate with GS1 Ensure consistent messaging to stakeholders; obtain access to 

GTIN registry. 

Collaborate with the Food and 

Drug Administration (FDA) 

Ensure up-to-date list of NDCs and consistent messaging to 

stakeholders

Collaborate with AAP and other 

associations

Collaborate with AAP and other associations in development and 

roll-out of training and outreach programs; maintain participation 

in AAP 2D barcoding working group meetings.

Education and outreach 

Mapping table Provide GTIN to NDC to CVX and MVX mapping so that systems 

can be developed and tested to accommodate 2D barcoded data. 

Implementation Provide educational materials and training for end users. 

Change management

Stakeholder engagement Ensure that roles and responsibilities among stakeholders are 

clear. Keep stakeholders engaged to facilitate their members’ 

involvement and ensure that changes are communicated.

Update 2.5.1 guide The 2.5.1 guide is the HL7 source for immunization information 

exchange: incorporating barcoding guidance into the guide will 

ensure that stakeholders are aware of changes.

Pilot implementation Pilot implementation will test 2D barcodes in use, especially with 

EHRs and IIS, so that troubleshooting can occur prior to largescale implementation. 

must be HL7 tables to support interoperability, and they should support all vaccine products 

on the market both on the public side as well as the private-purchase side. 

This proposed solution leverages GS1’s existing services for issuing and maintaining GTINs 

and CDC’s current maintenance of mapping tables. The CDC 2.5.1 implementation guide can 

be updated to reflect these relationships and provide links to the necessary mapping tables 

as appropriate.

The CVX and MVX mappings are HL7 tables and, thus, are part of the overall standard. It is 

extremely important that look-up tables be kept up to date. Some legacy systems have CVX 

and MVX hard-coded in them, and having a centralized mapping table avoids the risk of 

having individual vendors maintain them. Stakeholders with whom we spoke asserted the 

importance of transparency and continuity in developing implementation guides and 

mapping tables. In addition, CDC’s 2.5.1 implementation guide is referenced in the 

meaningful use criteria. Given that the tables and the guide need to be together, it is 

important that the guide be updated with the location of the mapping table.
Chapter 8 — Summary Results and Conclusions

8-10 

CDC currently maintains mapping between the CVX and Current Procedural Terminology 

(CPT) codes and the NDC mapped to CVX and MVX codes. These mappings are to support 

users throughout the immunization life cycle. The NDC is used for a variety of purposes 

throughout the immunization life cycle. CPT codes are primarily used to describe procedures 

to facilitate payment. Thus, the GTIN mapping going forward should include both the NDC 

and CPT.

GS1 is responsible for issuing GTINs and maintaining them in a registry, which ensures that 

there are no duplicate GTINs. If a manufacturer submits a request for a duplicate GTIN, GS1 

works with the manufacturer to identify alternatives. We determined that there are no 

duplicates in the FDA database, but using the GS1 registry will ensure that duplicates do not 

occur in the future. 

8.2.2 Collaboration and Coordination with Stakeholders

We recommend ongoing collaboration among CDC, AAP, GS1, FDA, Association of 

Immunization Managers (AIM), American Immunization Registry Association (AIRA), and 

other stakeholders to ensure that all parties responsible for the GTIN, NDC, and CVX and 

MVX understand the data exchange implications of the 2D barcode for stakeholders in the 

immunization domain. Coordination and discussion are particularly important during 

implementation and ongoing maintenance.

Coordination with GS1 will be important because business processes will need to be 

established by which new GTINs are added to the proposed GTIN to NDC to CVX and MVX 

mapping table. During implementation, GTINs for vaccine products will need to be mapped 

to CVX MVX, etc. Sufficient time must be allowed for testing of system updates and 

processes. In addition, as new products come to market and the GTINs are updated, a 

consistent process for communicating changes is needed so that tables can be updated.

GS1 has indicated that it will assist providers once the guidance and content are finalized. 

Assistance includes continuing to maintain the GS1 specifications, issuing guidance to 

manufacturers, and providing general specifications as needed. GS1 also will provide 

guidance about how to purchase and use a scanner. As part of its regular processes, GS1 

provides training to software consultants and certifications. But because GS1’s role is to 

develop the standards and provide general support, they do not provide customized 

guidance. Thus, stakeholders will likely turn to other resources for support. 

The FDA assigns labeler codes and maintains the database of segmented NDC numbers. The 

FDA is also a member of GS1 and, thus, has access to the GS1 registry of GTINs (GS1 

Healthcare US, 2011b). Coordination with the FDA will support maintenance of accurate and 

timely mapping tables. Coordination will also allow both agencies to stay abreast of 

automated identification activities for biologics, such as 2D barcoding and serialization.
Chapter 8 — Summary Results and Conclusions

8-11 

Because of the FDA’s position, its communication with stakeholders is extremely important 

in the success of this effort. Collaborating with the FDA will facilitate consistent messaging 

to stakeholders.

Lastly, AAP has led the 2D barcoding initiative and offers a neutral forum where technical 

aspects of implementation and data exchange specific to immunization can be discussed. 

AAP, AIM, AIRA, and other professional associations can coordinate communications that 

will ultimately reach large numbers of providers beyond pediatricians.

8.2.3 Education and Outreach

One concern that has been universally mentioned is the importance of education and 

training of those who will print, maintain, and use the 2D barcode. In fact, our interviews 

often turned into educational sessions. As referenced in the process map, a variety of 

stakeholders are involved. Each of them will need to understand the content of the 

standards mapping to make necessary changes to their systems. Thus, CDC must ensure 

that mapping is readily available and communicated to all stakeholders, especially to 

information systems vendors and those in the health IT technical and policy community.

In addition to ensuring that business and technical requirements are available, educational 

materials also need to be developed and delivered. Although the barcode scanner is 

relatively easy to use, it still requires some training. The scanning itself is a piece of an 

overall education effort that can include workflow implications and downstream impacts. 

This training should include using the scanner, verifying scanned information, and 

developing procedures for recalling incorrect information and making changes. 

Troubleshooting should also be part of the training, which might include procedures for error 

management, such as accidentally scanning the wrong item or attributing a vaccine to the 

wrong person. Because of the large number of trainees who are geographically distributed, 

asynchronous methods are suggested. These methods include webinars, video, and 

instruction manuals. These can be supplemented with online synchronous methods as 

needed or appropriate for questions and answers. Then, materials can be updated 

accordingly.

8.2.4 Change Management

A commonly cited concern of interviewees was how changes will be accommodated in the 

future. There could be changes in vaccines themselves, such as in new products coming on 

the market, or changes in manufacturers. Sometimes the standards themselves change. For 

example, the HL7 standards are updated periodically. The regulatory environment might 

also change, such as the new Health Insurance Portability and Accountability Act (HIPAA) 

transactions and the updates to the privacy and security rules. In addition, vendor products 

and functionalities could change as the meaningful use criteria continue to evolve. 

Regardless of the source of change, a consistent way of citing and accommodating future 
Chapter 8 — Summary Results and Conclusions

8-12 

change in standards or barcode content is necessary. This issue points to the need for more 

consistent communication channels for stakeholders throughout the health care delivery 

system.

For change management procedures to be successful, roles and responsibilities of 

stakeholder groups should be clear. Although the AAP has been leading this effort, in the 

years following implementation, 2D barcode use may ultimately become accepted practice. 

Thus, representatives from stakeholder groups need to be kept apprised of status and 

engaged in the effort.

We suggest incorporating barcoding technical guidance in the CDC 2.5.1 implementation 

guide. The guide is a well-recognized source of information for immunization messaging. In 

addition, this guide is referenced in the meaningful use criteria. One of the public health 

requirements involves vaccine messages. If providers meet meaningful use criteria, then 

they qualify for payments. Thus, incorporating 2D barcoding in the guide provides an 

incentive for a variety of stakeholders to stay current with changes to the code.

8.2.5 Pilot Implementation

Although we have conducted interviews and document review, testing an implementation is 

the best way to fully understand how the 2D barcode will be operationalized in practice. We 

recommend conducting a staged pilot to test implementation, with an emphasis on 

information systems integration and usage at the practice level and data exchange between 

provider locations and IIS. The pilot should also be part of a technical assistance program 

that reviews functionality and capabilities for IIS and guides or supports implementation.

The results of the pilot can be used to test information systems, work flows, and educational 

materials. 
 

R-1 

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APPENDIX A: INITIATIVES OUTSIDE NORTH AMERICA
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The United States and Canada are not alone in pursuing vaccine product identification 

initiatives. Although there are differing underlying rationales and operating models for 

different countries’ approaches, a common factor is a decision to leverage GS1 standards. 

Brazil 

In 2009, the Brazilian legislature passed a law (Act 11.903) to combat fraud and 

counterfeiting (Brazil 11.903 Track and Trace Mandate, 2010). The legislation aimed to build 

and implement a full serialization system for all prescription medications. The core of the 

proposed system was a randomized serial number located on a GS1-compliant 2D data 

matrix (called the Medicine Single Identifier) that would be found on every medical pack 

sold in the country (Taylor, 2010e). 

The serial number would link to a database that contained each medical pack’s ANVISA—the 

Brazilian regulatory agency charged with protecting the pharmaceutical market—registration 

number, lot number, manufacturing date, expiration date, the taxpayer numbers of the 

companies remitting and receiving the product, and the transaction date. The ANVISA 

system would have full track and trace capabilities; as proposed, the system would be able 

to trace all product movement, from manufacturer to end user (Taylor, 2010e). 

Manufacturers would be responsible for making sure that all of their products contain the 

necessary labels, and ANVISA would supply product dispensers with scanners to verify the 

authenticity of products they sell.1 

However, after pharmaceutical resistance and the resignation of ANVISA’s Chief Executive in 

January 2011, this plan reversed course (Allen, 2010). A task force was assigned to review 

and make recommendations for Act 11.903 and, ultimately, ANVISA decided to cease plans 

for a traceability system for medicines based on serialized security seals. Generally, drug 

makers seem to be lobbying for direct printing of codes onto the pack rather than a security 

label. Act 11.903 was ultimately repealed (Taylor, 2011a). 

France 

In 2007, the French Health Products Safety Agency (AFSSAPS) announced new CIP 13 

coding requirements for pharmaceutical products (France CIP 13 Coding Update, 2009). The 

requirements stipulated that all pharmaceutical products distributed in France after January 

1, 2011, must possess an ECC200 2D data matrix barcode that contains a 13-digit CIP 13 

code, the lot number, and the expiration date. All products must also possess a vignette 

sticker, which pharmacists can use for reimbursement; the sticker includes the data matrix, 

1 The proposed system also sought to place a security hologram (printed by the national mint) and a 

2D data matrix on a self-adhesive, tamper-evident label (Allen, 2010). Pharmaceutical companies 

have lobbied aggressively against this aspect of the system. In their view, placing a governmentsupplied security label on all products would be difficult to accomplish, and a serialization system is 

itself enough to protect against counterfeiting and reimbursement fraud (Taylor, 2010a). 

A-1 
Impact of a Two-Dimensional Barcode 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

the CIP 13 code, the reimbursement rate, and the price (France CIP 13 Coding Update, 

2009). 

France’s CIP 13 scheme is used primarily for reimbursement, patient safety, and batch 

number traceability (AFSSAPS originally envisioned using a 7-digit CIP code but added digits 

to strengthen traceability). The CIP 13 code is not a serialization system. However, the 

hardware required for CIP 13 is the same as the hardware required for serialization, and the 

application of CIP 13 codes provides a foundation for serialization and future initiatives 

aimed at improved packaging and anticounterfeiting (France CIP 13 Coding Update, 2009). 

The CIP 13 scheme will also be compatible with the planned European coding system (the 

European Article Number [EAN] structure) (CIP, 2011). 

South Korea 

In 2008, South Korea laid out a timeline to implement a track and trace system using the 

Korean Drug Code (KDC) in a GS1-compliant barcode. Beginning in January 2008, South 

Korea mandated that all pharmaceutical products larger than 15 mL be labeled with the KDC 

(Bosch Packaging Technology, 2010). By January 2010, all pharmaceutical products, 

regardless of size, were to be labeled with the KDC. By January 2012, specified drugs must 

possess labels with a GS1 data matrix or a GS1-128 barcode. Finally, by January 2013, all 

prescription drugs must have labels with a GS1 data matrix or GS1-128 barcode (Rodgers, 

2011). 

In addition to introducing the KDC and requiring that labels include more advanced 

barcodes, South Korea is requiring that pharmaceutical drugs be equipped with radiofrequency identification (RFID) tags (Mansell, 2010; Ton-hyung, 2010). South Korea is 

requiring that at least 50% of all Korean pharmaceuticals sold by 2015 have RFID tags 

(Ton-hyung, 2010). RFID tagging may allow South Korea to improve their low recovery rate 

for substandard drugs (around 20%) (Ton-hyung, 2010). Additionally, the tags will aid in 

distribution efficiency, inventory control, reduction of prescription errors, prevention of 

theft, and identification of counterfeit drugs. Government officials estimate that RFID 

tagging would generate 910 billion won in drug production costs through 2015 and would 

save pharmaceutical companies 1.8 trillion won per year in distribution and inventory costs 

(Ton-hyung, 2010). 

Turkey 

In 2008, the Turkish Ministry of Health announced the creation of the Ilac Takip Sistemi 

(ITS). ITS is a serialization scheme that will give Turkey the ability to track and trace 

pharmaceutical products (down to the unit pack level) from importation through dispensing. 

Manufacturers would be required to equip all health care products—prescriptions, over-thecounter medications, dietary supplements—with a GS1-compliant 2D data matrix containing 

A-2 
Appendix A — Initiatives Outside North America 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a unique serialized identifier (Taylor, 2008). At each point in the supply chain, product 

handlers will scan the product into the system to allow the Ministry of Health to track all 

products in a centralized database (Taylor & Duman, 2009). 

The impetus for creating ITS came from widespread reimbursement fraud that costs Turkey 

an estimated $150 million/year (Taylor & Duman, 2009). The system would also help 

decrease counterfeiting and the prevalence of illegal pharmaceutical drugs on the Turkish 

market (Taylor & Duman, 2009). When a pharmacist scans a product, the system would 

relay a message indicating whether the product should be dispensed. 

The ITS system received pushback from Turkish pharmacists. Some pharmacists were 

concerned that upgrading their infrastructure was not in their financial best interests (Taylor 

& Duman, 2009). Turkish pharmacists had some difficulty with barcode scanners. Some 

scanners sold to pharmacies as 2D-readable are unable to read the new 2D data matrix. 

The algorithms used in the readers may not be sufficiently robust to give reliable results. 

Pharmacists have also been concerned that if the Ministry of Health does not provide 

reimbursement for products without a 2D barcode and if pharmaceutical manufacturers are 

unwilling to accept the return of unused products, they would be left to bear the cost of 

unused products (Taylor & Duman, 2009). These concerns have delayed repeatedly Turkey’s 

aggressive timeline for implementation. 

United Kingdom 

There are no initiatives sponsored by the UK government; however, SecureTrace, a 

consortium of UK companies, began a pilot project in 2009 to track and authenticate drugs 

along the supply chain. SecureTrace’s main project goal was to show how serialization and 

authentication could be done simultaneously and successfully (Taylor, 2010g). The 

SecureTrace consortium consists of several solution providers (Authentix, Camdata, Image 

Solutions, And Automation, Domino Printing Sciences, Ingenia Technology, Pera Innovation, 

and GIS), a university (Loughborough University), and a pharmaceutical drug company 

(Reckitt Benckiser) (Case Study, 2010). 

The SecureTrace pilot uses serialization and tracking through RFID and on-pack data matrix 

tracking codes at the carton level. Authentication is accomplished through forensic signature 

inks and laser surface authentication (Case Study, 2009) and all information is stored in a 

master database. Based on this process, it is possible to authenticate and verify 

pharmaceuticals with handheld field readers at any point in the supply chain (Case Study, 

2009). This pilot originated from the idea, held by SecureTrace, that serialization will not 

adequately prevent pharmaceutical counterfeiting and diversion without authentication 

(Taylor, 2010g). Thus, the SecureTrace pilot demonstrated the feasibility of simultaneous 

A-3 
Impact of a Two-Dimensional Barcode 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

serialization and authentication through its success in using different technologies 

simultaneously (Taylor, 2010g).2 

Sweden 

The European Federation of Pharmaceutical Industry Associations (EFPIA) chose Sweden to 

pilot its project to verify the identity of pharmaceuticals at the point of dispense. Through 

this project a 2D data matrix code is placed onto each medicine pack. This code contains 

the product code, expiration date, batch number, and a unique serial number. This code is 

readable with an optical scanner directly at the pharmacy (EFPIA, 2009). The motivation 

behind this project comes from the lack of conformity within mass serialization for 

medicines. Currently in Europe there are at minimum 10 different codes being used for 

serialization purposes (Taylor, 2010d). Without international standardization, significant 

investment will be wasted supporting various standards that will inevitably become obsolete 

(Barron et al., 2010). 

Overall the pilot was extremely successful, boasting a 94% successful read rate of the code 

in 0.5 seconds and a 99.9% successful read rate in 2 seconds. Of the 230 pharmacists 

participating in the study, 123 provided feedback, and 94% of those providing feedback felt 

the system was easy or very easy to use; 96% reported that the extra effort needed to 

operate the system was acceptable or better (Barron et al., 2010). Projected benefits from 

the system include more efficient recalls, power to combat reimbursement fraud, assurance 

that patients receive the desired product before expiration, and counterfeit product 

detection (Taylor, 2009). Although achieving these benefits is important, the purpose of the 

pilot is not to improve existing systems, but rather to demonstrate the feasibility of 

implementing a system that would standardize international serialization (Barron et al., 

2010). 

Issues that arose in the pilot include confusion between the linear and 2D data matrix 

barcode, resulting in an error and a prompt to rescan. Another issue arose when customers 

decided not to purchase a product after it had been scanned. Because the product had been 

scanned it was marked as already dispensed, so when the next customer tried to purchase 

the product, it presented as already dispensed, causing an error. Based on these pilot 

results, the EFPIA’s next steps are to fix kinks in the system and begin pushing for a 

harmonized product coding system in Europe that uses 2D datamatrix coding (Taylor, 

2010d). 

2 It is important to note that SecureTrace’s system is compatible with the BRIDGE traceability project 

and the European Federation of Pharmaceutical Industries and Associations (EFPIA). While aligning 

its pilot with EFPIA’s objectives to support EFPIA’s position and to contribute to some form of 

standardization in the industry, SecureTrace simultaneously branched out to investigate two other 

important areas: practical integration of technology in the supply chain and at the production line, 

and supplementary authentication technologies that do not affect packaging design (Authentix-led 

Consortium Launches Pilot Program for Pharmaceutical Safety, 2010). 

A-4 
Appendix A — Initiatives Outside North America 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

India 

In September 2010, India’s Ministry of Commerce agreed to a proposal by Pharmexil, a 

trade group that represents drug exporters, to employ a track-and-trace system using 

barcode technology and GS1 coding standards for all exported pharmaceutical products. On 

January 10, 2011, India’s government officially approved a resolution (Public Public Notice 

No. 21 [RE-2011]/2009–2014) that set implementation for the serialized coding scheme for 

July 1, 2011. In early June, this deadline was postponed. The current rollout is predicted to 

mandate codes on tertiary packaging by October 1, 2011, and codes on primary and 

secondary medicine packaging by January 1, 2012 (Taylor, 2011b). Postponement is due in 

part to aggressive lobbying from pharmaceutical companies who feel that the time frame is 

too short to test, employ, and validate the mandated changes (Taylor, 2011b).3 

China 

On April 9, 2008, China’s State Food and Drug Administration (SFDA) launched a track-andtrace initiative declaring that all individual pharmaceutical products sold in the Chinese 

marketplace—not just those made in China—needed to be serialized by December 2011. 

The aims of this program include increasing patient safety; reducing drug counterfeiting; 

offering online, phone, and short message service (SMS) authentication of drugs; 

developing a national warning system to detect unusual drug movements; and tracking 

drug movement along the supply chain (China SFDA Mandatory Serialization Update, 2009). 

SFDA plans to run a centralized national database of serial numbers through which they will 

issue and manage serial numbers for registered drugs. This database will include an online 

portal, through which pharmaceuticals can register products and obtain serial numbers. 

These services would be fee based, and the serial number would be 20 numerical digits that 

would include the serial number, manufacture code, and check digits. This check code maps 

one-to-one with China’s NDC, 9-digit serial number and 4-digit encryption number. A final 

deadline for the serialization and track and trace of all drugs has not yet been set (China 

SFDA Mandatory Serialization Update, 2009). 

Argentina 

In 2011 Argentina adopted a datamatrix serialization system and beginning June 15, 2011, 

began requiring that laboratories operating in Argentina implement this government 

tracking system. This new system is compatible with GS1 international standards, and 

under this system drug authentication can be completed online or by telephone. This is a 

very important advancement for Argentina because counterfeited drugs are one of the most 

3 In response to the new traceability requirements, an Indian company, Goose, started a home-grown 

serialization system to assi st pharmaceutical companies. The new platform is called “Procon 

Tracker” and enables serialization, e-pedigree, and drug validation for any pharmaceutical 

company. This system is GS1-compliant, and codes can be printed in a readable format to be 

validated over the phone, using a website, or through SMS (Procon Tracker, 2011). 

A-5 
Impact of a Two-Dimensional Barcode 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

serious issues facing their public health system. It is estimated that roughly 10% of 

medicines found in the country are counterfeited (Bitoren, 2011). 

Germany 

Aegate is a UK-based company whose authentication system scans a datamatrix code on 

pharmaceutical products when disbursed to verify their validity and check their expiration 

date. In early 2010 Aegate began collaborating with the Federal Union of German 

Associations of Pharmacists (ABDA) and announced plans to run a 7-month pilot of this 

system in Germany (German Association of Pharmacists [ABDA], 2010). The idea of the 

pilot was not only to test this system, but also to test the viability of parallel importers 

participating in a mass serialized system. Therefore, the pilot involved removing and 

invalidating the old code, and replacing it with the new one (Taylor, 2010c). 

In early 2010 the European Association of Euro-Pharmaceutical Companies (EAEPC) agreed 

to participate in the pilot, but later that year, the project began experiencing problems and 

the pilot was put on hold. One reason for this was that manufacturers and wholesalers were 

signing up for the pilot less quickly than expected. Another issue was that implementing 

barcodes, readers, and necessary IT infrastructure was estimated to cost at least €200,000 

(Taylor, 2010c). Given that a legal mandate for a coding system in Europe is not 

guaranteed, this is a significant investment. 

Another project just recently started in the place of the postponed Aegate-ABDA pilot. The 

SecurPharm project, a collaboration between Bundesverband der Arzneimittel-Hersteller e.v. 

(BAH), Blenheim Pharmacal, Inc., BPI Technologies Corporation, VFA Solutions, Pro 

Generika, PHAGRO, and ABDA was announced August 31, 2011 (Schmidt, 2011). It is 

predicted that SecurPharm will become the standard in Germany, and possibly Europe, 

based on the participation of the German Association of Pharmaceutical Manufacturers, the 

German Society of Hospital Pharmacists, and the German Wholesaler Association. The 

purpose of the project is to employ safety features mandated in the EU Directive 2001/83 

(Pharma Directive). The initiative’s motto is “end-to-end,” indicating that validation and 

verification will take place in the pharmacy, not in each supply phase. This project will use 

2D matrix codes (like in the EFPIA pilots in Sweden) and two separated data management 

systems (not a central database, as seen in other models). The pilot is set to begin in 2013 

(Schmidt, 2011). 

Italy, Greece, and Belgium: Aegate Users 

Despite the current postponement of the German Aegate-ABDA pilot, Italy, Greece, and 

Belgium do use Aegate’s system (German Association of Pharmacists [ABDA], 2010). 

Aegate began working in Greece and Belgium in 2007 with the support of the Panhellenic 

Pharmacists Association and the Association of Pharmacists of Belgium (APB), respectively. 

A-6 
Appendix A — Initiatives Outside North America 

 

 

 

 

 

 

 

Over two-thirds of Belgium pharmacies can now access the Aegate system through their 

software providers, as can 80% of Belgium pharmacies (History of Drug Identification Pilots, 

2009). With collaboration from software providers CSF, Newline, PharmaService, and 

Farma3, Aegate was launched in Italy in 2008. The service was fully integrated into existing 

pharmaceutical software and used the standard Bollini 1D barcoding technology. As 

previously described, the Aegate system uses 2D data-matrix serialization technology to 

authenticate pharmaceuticals when dispensed from a pharmacy. 

A-7 
 

 

 

 

 

 

 

DISCUSSION GUIDE FOR VACCINE MANUFACTURERS 

The Centers for Disease Control and Prevention (CDC) has contracted with RTI International, a 

not-for-profit research institute, to conduct a study of the impacts a two-dimensional barcode would have 

on vaccine production, clinical documentation, and public health reporting for stakeholders in the U.S. 

immunization system.1 Stakeholders include vaccine manufacturers, vaccine users (e.g., immunization 

providers, immunization program managers), and immunization data users (e.g., immunization 

information systems, data exchange groups, vaccine-related tracking systems). Please see also our 

accompanying Project Abstract. 

The focus of our conversation is on the operational and regulatory issues, cost and benefit 

categories, and other considerations for including a two-dimensional barcode (including Global Trade 

Identification Number [GTIN], lot number, expiration date, and potentially other information) on all USlicensed vaccine products. 

A comprehensive understanding of the issues, costs, benefits, and considerations is imperative for 

the success of this study. Our conversation is confidential. We will be speaking to all vaccine 

manufacturers, and in that respect it will be known that we engaged your organization. However, all 

comments, anecdotes, data, and other information provided by your firm will be aggregated with those of 

other firms in all deliverables and communications with third parties, including CDC. 

To supplement our note-taking and fill any gaps or clarify any comments, with your permission, 

we would like to audio record our conversation. The recording will only be used to ensure we accurately 

documented your insights. A copy will be provided to you. We will permanently delete the recording after 

this project has ended. 

Our questions are purposefully open-ended; while we have specific question topics we would like to 

discuss, we aspire to have a conversation as opposed to a strict Q&A session. Question topics cover: 

•	 fill and finish operations and process engineering and how these may be affected by inclusion of a 

two-dimensional barcode on product labels; 

•	 associated vaccine label requirements, considerations, and regulatory issues; 

•	 pertinent cost and benefit categories [including, one-time vs. recurring; fixed vs. variable; capital, 

labor, services, and materials]; 

•	 information technology, barcode, and data exchange standards; 

•	 indirect regulatory and cost considerations, including revalidation of production lines and changes 

to standard operating procedures (SOPs); 

•	 non-manufacturing operations potentially affected, including information technology, marketing, 

and tracking and compliance groups; and 

1 Specifically, a two-dimensional barcode printed on the label affixed to the immediate container (i.e., vial, prefilled 

syringe) of a finished vaccine product licensed for sale in the US. 

B-1 
 

 

 

•	 perspectives on the relevance of such barcodes for vaccine-tracking systems, registries, and 

electronic health records both in general and specific to your company. 

General Fill and Finish and Labeling Operations 

1.	 Please review the accompanying table presenting our understanding of the products licensed for 

the US market. Is this information correct? If not, please offer corrections. 

2.	 Characterize and describe your labeling operations beginning with how and where labels are 

printed, how those labels are affixed to finished products’ immediate container (i.e., vial, prefilled 

syringe), and how completed products move to inventory and then through to shipment. 

3.	 How many production lines do you have in the US? Is there a 1:1 ratio between labeling systems 

and production lines? 

4.	 Describe any change-over processes from production of different vaccine products for the US 

market and those for non-US markets. What are the critical considerations? 

5.	 Describe the interface and method by which systems are programmed to print and label products. 

What specific labeling technologies and systems are currently used and how do such systems vary 

according to different product containers, if at all? How flexible are these systems? Are these 

systems capable of printing two-dimensional barcodes? 

6.	 What are important operational and quality considerations for the labeling process, and do these 

considerations vary by presentation or label type (i.e., printed label, peel-off label)? 

7.	 What are common challenges (if any), current or past, with labeling operations, fill and finish 

lines, or other operations associated with changing labels, label media, or increasing the amount 

of information printed on a given label, including the addition of barcoded information? 

8.	 After the label is affixed to the immediate container, how are products tracked as they move 

through the remainder of the facility, to warehousing, and for shipment? At what stages would 

barcoded information on an immediate container be advantageous to a manufacturer and why? 

9.	 Apart from barcodes, are there any automated identification technologies or strategies used or are 

any such technologies emerging? If so, please explain the pros and cons of such technologies, as 

you understand them. 

Product Labels 

10. Explain the overarching considerations and implications associated with including a twodimensional barcode on a product label.
 

11. Vaccine product labels are regulated by FDA, and changes to labels require FDA review and 

approval under 21 CFR 601.12(f). Labels include those on immediate outer packaging and 

wrapping, product labels on immediate containers, and product inserts. 

What FDA requirements, industry consensus standards, and any other standards are relevant for 

B-2 
 

 

 

o

o

o

o

o

o

o

o

o

o 

o 

o 

o 

o 

o 

what information is presented on labels and how that information is presented? What barcoding 

standards are followed by your firm? 

12. What label media are used for your products? How does vaccine presentation impact the relative 

ease or difficulty of including two-dimensional barcodes on labels? 

Multi-dose vials 

Single-dose vials 

Injectable pre-filled syringes 

Intranasal pre-filled syringes 

Lyophilized vaccines (require reconstitution) 

Any thoughts about new technologies, e.g., transdermal? 

13. How do different label media and different label sizes factor into the feasibility of including a 

two-dimensional barcode? 

14. Do you currently manufacture in the US any products for any US or international markets that 

include two-dimensional barcodes on their labels? Does your company import vaccine products 

from non-US manufacturing plants that print two-dimensional product labels on products for any 

national markets? Please explain. 

15. What experience(s) does your company have with two dimensional barcoding any of its products 

(whether vaccine or not)? What lessons have you learned from this experience? 

16. Who are the major vendors for printing technologies, tooling, label media, and other 

consumables? Have technology or product offerings evolved in light of FDA’s barcoding 

requirements, and if so, how? 

One-time Costs, Time Requirements, and Similar Considerations 

We need your assistance in characterizing and understanding what the one-time cost variables are for us 

to include in our economic analysis. While dollar-denominated estimates are helpful, it is most important 

for us to understand tooling, labor effort, and systems requirements denominated in technical units, such 

as number of labor hours, first. 

17. What are the cost variables that would potentially be affected, such as: 

Capital requirements and any changes in tooling (printers, automation systems) 

Production line recertification 

Changes in SOPs 

Interface programming and line testing 

Software technology 

Training and certification for line managers and line workers 

FDA approvals or inspections 

Implementation planning and on-time management expenses 

Others? 

B-3 
 

 

 

 

 

o 

o 

o 

o 

o 

o 

o 

o 

o 

o 

o 

o 

o 

18. What would be the total implementation time to make such a change? How much lead time would 

be required? How much production-line down time would be required to implement twodimensional barcoding? 

19. How would this affect inventory and warehousing procedures? Would production cease
 

temporarily, or would you alternate implementation by lines? Please explain.
 

20. Would this change trigger revalidation of the production line by FDA? Please explain. 

21. Have any cost or feasibility studies been conducted by your company? Please explain. 

22. How would one-time costs be recouped? Are there any benefits that may offset these costs and if 

so, what are they? 

23. Are there any upcoming changes in your labeling operations that might facilitate implementation? 

24. What considerations or facilitators in the broader immunization environment may influence or 

affect adoption decisions? 

25. What factors would affect the timing of any adoption decisions? Characterize any differences 

under scenarios that vary by a 1-year, 2-year, or 3-year implementation time. 

Recurring Costs and Considerations 

26. How may including lot number and/or expiration date information affect the cost of 

implementing two-dimensional barcoding relative to linear barcodes? If there is an increase in 

cost, what would account for it? What could be done to offset any increase in cost? 

27. Would inclusion of a two-dimensional bar code on a product label change the label media used? 

If so, please explain and offer a comparative assessment. 

28. What are the recurring cost variables that would potentially be affected (and how many current 

activities be incrementally less or more resource intensive), such as: 

Labor effort 

Periodic interface programming and line testing 

Selection of label media 

Consumables, such as inks or other inputs 

Quality control and assurance 

Annual software licensing agreements or other costs 

Fees associated with membership in standards groups 

Others? 

29. Would two-dimensional barcodes have special considerations for the following (and if so how): 

Products with multiple lot numbers 

Any products being alternately labeled as a pharmaceutical or a medical device 

Products produced by one firm but marketed under agreement by another 

Combination vaccines 

Others? 

B-4 
 

 

30. How would operations such as those for information technology, marketing, and tracking and 

compliance groups be affected? 

31. What economic benefits may offset these costs? Please describe key variables for us. 

Other 

32. Did your company respond to the FDA’s request for comments on the proposed waiver for 

barcoding that may permit two-dimensional barcoding of vaccine product labels? What are your 

company’s views, generally? 

33. What non-US regulatory trends affecting labeling and automated vaccine product tracking are 

important for us to understand? What trends in general harmonization should we be aware of? 

34. Does your company have an interface to and use vaccine-tracking systems maintained by the 

public health community, immunization information systems, and electronic health record 

systems? Does your company use the systems or accept data feeds from them? Please describe 

any advantages or disadvantages associated with these systems for your company. 

35. What are your views on immunization registries? 

36. Does your company track or monitor general compliance with immunization schedules? Please 

explain. 

37. What industry trends about labeling, vaccine product presentations, or the introduction of new 

products influence willingness to adopt two-dimensional barcoding technologies? 

38. Imagine 5 years from now. Do all of your company’s vaccines have two-dimensional bar codes? 

If yes, what information does the barcode include? If no, why? 

39. Are there any other benefits to two-dimensional barcodes that we have not yet addressed? Are 

there any other barriers/concerns about two-dimensional barcodes that we have not yet 

addressed? 

B-5 
 

 

 

 

DISCUSSION GUIDE FOR PROFESSIONAL ASSOCIATIONS 

The Centers for Disease Control and Prevention (CDC) has contracted with RTI International, a 

not-for-profit research institute, to conduct a study of the impacts a two-dimensional barcode would have 

on vaccine production, clinical documentation, and public health reporting for stakeholders in the U.S. 

immunization system.1 Stakeholders include vaccine manufacturers, vaccine users (e.g., immunization 

providers, immunization program managers), and immunization data users (e.g., immunization 

information systems, data exchange groups, vaccine-related tracking systems). Please see also our 

accompanying Project Abstract. 

We are interested in gauging the impact of two-dimensional, or data matrix, barcodes containing 

product identifiers, lot number, and expiration date for vaccines on pediatricians, OB/GYNs, family 

physicians, and general internists (see Figures 1 and 2). Thus far, pediatricians, as represented by the 

American Academy of Pediatrics (AAP), have advocated for including two-dimensional bar codes on 

vaccine products. This is reflected in AAP’s support for the Food and Drug Administration’s (FDA’s) 

Updated Draft Guidance for Industry (August 2010). 

Two-dimensional barcodes would make it possible for immunization providers to use a scanner to 

read the barcode and automatically enter product, lot, and expiration data into electronic information 

systems, such as practice management software, electronic health records (EHRs), immunization 

information systems (IIS) or registries, and billing systems. The price of a barcode reader is between $50 

and $100, generally. 

The focus of our conversation is on prevalence of immunization administered by your members, 

vaccine inventory management, documentation (including the individual patient medical record), data 

exchange, and the use and uptake of information technology. Our conversation is confidential, and with 

your permission, may be recorded. All comments, anecdotes, data, and other information provided by 

your organization will be aggregated with those of others in all deliverables and communications with 

third parties, including CDC. 

Questions are purposefully open-ended and are illustrative; while we have specific question 

topics we would like to discuss, we aspire to have a meaningful dialog as opposed to a strict Q&A 

session. We have used bold-font topic headers for easy scanning of the topics of interest. Some of our 

questions may be best answered by a practice manager or nurse supervisor. 

Figure 1: Example of linear barcode 

Current linear barcodes required by the FDA 

contain only the vaccine product identification 

information. 

Figure 2: Example of two-dimensional barcode 

A two-dimensional, or data matrix, barcode can 

include product identification information as well 

as lot number and expiration date. 

1 Specifically, a two-dimensional barcode printed on the label affixed to the immediate container (i.e., vial, prefilled syringe) of a finished 

vaccine product licensed for sale in the US. This code would also appear on secondary packaging. 

B-6 
 

 

 

1.	 What is the prevalence of vaccine administration by your members and what environmental factors or 

business drivers influence this prevalence? 

2.	 How is immunization by members anticipated to change over time, to the best of your current 

knowledge? 

3.	 What proportion of your members use electronic health records (EHRs)? How do you imagine your 

response will have changed 5 years from now? What is the prevalence of information technology use 

and electronic data exchange for your members generally? 

4.	 Thinking generally, what concerns or potential benefits do you anticipate your members would have 

regarding the placement of a two-dimensional barcode with product identifiers (GTIN, which 

includes the NDC), lot number, and expiration date on a vaccine product label on the products 

immediate packaging, such as a vial or prefilled syringe, and on the product’s secondary packaging, 

such as a 10-vial box? 

5.	 Does your organization currently have a committee or individual looking into the barcoding issues? Is 

organization doing anything in support of barcoding or to learn more about the issue? 

6.	 What does your organization need to move ahead in the barcoding arena, such as technical assistance 

or educational materials? 

7.	 What investments would members need to make in workflow changes, training, hardware, etc. What 

do they have now and what will they need? 

8.	 As part of this project, we will be doing an economic analysis of the costs associated with 

implementing vaccine barcoding. We anticipate that the costs may differ among different specialty 

groups based on the volume immunizations provided and the type of vaccines administered. What 

information do you have about the costs of your members’ providing vaccines, if any? 

9.	 What information resources are there for understanding and segmenting the population of your 

members in the U.S., such as number of providers, stratification by office type, size, and EHR usage, 

and location? 

10. What issues haven’t we discussed which you think we should consider? 

Thank you. 

B-7 
 

 

 

DISCUSSION GUIDE FOR IMMUNIZATION PROVIDERS 

The Centers for Disease Control and Prevention (CDC) has contracted with RTI International, a 

not-for-profit research institute, to conduct a study of the impacts a two-dimensional barcode would have 

on vaccine production, clinical documentation, and public health reporting for stakeholders in the U.S. 

immunization system.1 Stakeholders include vaccine manufacturers, vaccine users (e.g., immunization 

providers, immunization program managers), and immunization data users (e.g., immunization 

information systems, data exchange groups, vaccine-related tracking systems). Please see also our 

accompanying Project Abstract. 

We are interested in gauging the impact of two-dimensional, or data matrix, barcodes containing 

product identifiers, lot number, and expiration date for vaccines on pediatricians, OB/GYNs, family 

physicians, and general internists (see Figures 1 and 2). Thus far, pediatricians, as represented by the 

American Academy of Pediatrics (AAP), have advocated for including two-dimensional bar codes on 

vaccine products. This is reflected in AAP’s support for the Food and Drug Administration’s (FDA’s) 

Updated Draft Guidance for Industry (August 2010). 

Two-dimensional barcodes would make it possible for immunization providers to use a scanner to 

read the barcode and automatically enter product, lot, and expiration data into electronic information 

systems, such as practice management software, electronic health records (EHRs), immunization 

information systems (IIS) or registries, and billing systems. The price of a barcode reader is between $50 

and $100, generally. 

The focus of our conversation is on provision of immunizations, vaccine inventory management, 

documentation (including the individual patient medical record), data exchange, and the use and uptake of 

information technology. Our conversation is confidential, and with your permission, may be recorded. All 

comments, anecdotes, data, and other information provided by your organization will be aggregated with 

those of others in all deliverables and communications with third parties, including CDC. 

Questions are purposefully open-ended and are illustrative; while we have specific question 

topics we would like to discuss, we aspire to have a meaningful dialog as opposed to a strict Q&A 

session. We have used bold-font topic headers for easy scanning of the topics of interest. Some of our 

questions may be best answered by a practice manager or nurse supervisor. 

Figure 1: Example of linear barcode 

Current linear barcodes required by the FDA 

contain only the vaccine product identification 

information. 

Figure 2: Example of two-dimensional barcode 

A two-dimensional, or data matrix, barcode can 

include product identification information as well 

as lot number and expiration date. 

1 Specifically, a two-dimensional barcode printed on the label affixed to the immediate container (i.e., vial, prefilled syringe) of a finished 

vaccine product licensed for sale in the US. This code would also appear on secondary packaging. 

B-8 
 

 

 

 

 

 

About Your Practice 

1.	 Characterize your practice, including total staff headcount and number of locations. Is your 

practice part of a larger network, health system, or corporation? 

2.	 If known and releasable, approximately how many patients are in your practice? 

3.	 What classes of vaccine does your practice provide, such as pediatric vaccines, adolescent 

vaccines, adult vaccines, and/or seasonal influenza? 

4.	 Approximately how many doses does your practice administer on a monthly or annual basis? 

5.	 Are you a VFC provider? 

a.	 What proportion of the doses administered is privately purchased and what proportion is 

government supplied? 

b.	 What impact do you imagine barcoded vaccines would have in terms of whether or not 

providers participate in the VFC program? 

6.	 How do you maintain medical records in your practice (paper, electronic, some combination)? 

7.	 How do you maintain billing records in your practice (paper, electronic, some combination)? 

8.	 What experience(s) (if any) have you had using barcoded products or barcode readers? Please 

describe any experience your office might have with using barcodes or other automated 

identification technology, for example with medical or office supplies. 

9.	 What benefits/costs do you anticipate for your practice with respect to using two-dimensional 

barcodes, if any? 

a.	 What kinds of changes do you anticipate for your practice, such as for software, 

workflow, and hardware? 

b.	 What help do you anticipate you would need in order to integrate barcoding vaccines into 

your practice? 

c.	 How do you anticipate your workflow would change due to barcoded vaccines? How 

would you train your staff? 

d.	 What barriers and facilitators do you see in implementing barcoded vaccines in your 

practice? 

Workflow for Vaccine Administration 

10. How is it determined when a patient needs an immunization? What are the procedures and what 

information resources are accessed? Who among your staff are involved? How do these differ if a 

patient is new your practice? 

11. Can you please briefly describe the process of administering vaccines in your practice? At what 

points during these steps is immunization data recorded, into what forms or systems, and for what 

purposes? Is the information later transcribed or transferred to other media? 

12. Consider now that the vaccine product label on the dose container includes a barcode containing 

information (product, lot, expiration date) that typically is recorded by hand. 

a.	 How would this affect your procedures and workflow? 

b.	 How would you like to see barcoded vaccines interface with medical records, practice 

management systems, IIS, and clinical decision support systems? 

B-9 
 

 

 

13. What procedures does your practice have in place to ensure that your immunization providers 

administer the correct vaccines to the right patients? 

Vaccine Inventory Management 

14. Discuss the procedures and processes for managing your vaccine inventory, from ordering 

through waste disposal. If procedures vary for VFC and non-VFC vaccine, please discuss them 

individually. How do you, for example, 

a.	 manage your inventory, including ordering, unpacking, placing into inventory (both 

physically and recording), etc? 

b.	 document deliveries? 

c.	 reconcile and audit deliveries with packing slips and invoices? 

15. What proportion of the vaccine delivered is contained in multi-dose vials? How do administration 

and recordkeeping practices vary when a dose is from a multi-dose container and not from a unitdose container? 

16. How would you anticipate that two-dimensional barcoding affect current inventory management 

processes? How would it affect future processes, such as if new information systems were 

installed in your practice? 

Recordkeeping, Billing, and Claims 

17. How does the information about a vaccine administered get into an individual’s medical record? 

How does it enter the billing system? How do you anticipate this would change if vaccines 

included a barcode? 

18. What is done to reconcile/verify that encounter (billing data) matches the medical record and 

inventory? What is done to assure that all vaccines which are administered are recorded and 

billed appropriately? 

19. Do you record immunizations in IIS? How does the information about a vaccine administered get 

into an IIS (immunization information system or registry) or health plan registry? 

20. How is the information about vaccine administration transferred to a billing system? 

21. Have you automated any information exchange between your practice management systems, 

registries, or any other system? 

Special Requests: HEDIS Audits, Pay for Performance Programs, School Forms, Camp Forms 

22. How frequent are and what is the level of effort associated with producing school forms, camp 

forms, sports pre-participation forms, and others? 

a.	 Approximately how many of these forms are completed by your practice each year? 

b.	 Do you use registries or other electronic information systems to assist in the development 

of these forms? 

c.	 How would you streamline this process if you could? 

d.	 Do you think barcoded vaccines would help with this process? 

23. With how many health plans does your practice contract (private contracts and Medicaid 

contracts)? On the average, how many audits (number of patient records) does each conduct in 

your practice each year for HEDIS and pay for performance programs? Do you think barcoded 

vaccines would help with this process? 

B-10 
 

 

 

 

 

 

 

PRELIMINARY DISCUSSION GUIDE FOR TECHNICAL ASPECTS 

The Centers for Disease Control and Prevention (CDC) has contracted with RTI International, a 

not-for-profit research institute, to conduct a study of the impacts a two-dimensional barcode would have 

on vaccine production, clinical documentation, and public health reporting for stakeholders in the U.S. 

immunization system.1 Stakeholders include vaccine manufacturers, vaccine users (e.g., immunization 

providers, immunization program managers), and immunization data users (e.g., immunization 

information systems, data exchange groups, vaccine-related tracking systems). Please see also our 

accompanying Project Abstract. 

The focus of this conversation is the impact on standards, data exchange, and related 

considerations for including a two-dimensional barcode (including Global Trade Identification Number 

[GTIN], lot number, expiration date, and potentially other information) on all US-licensed vaccine 

products. We will be reviewing the standards, but would like to gain an understanding of other 

considerations not included in the guidance. 

A comprehensive understanding of the impacts of this change is imperative for the success of this 

study. Our conversation is confidential. We will be speaking to the major standards organizations, and in 

that respect it will be known that we engaged your organization. However, all comments, anecdotes, data, 

and other information provided by your firm will be aggregated and de-identified in all deliverables and 

communications with third parties, including CDC. 

To supplement our note-taking and fill any gaps or clarify any comments, with your permission, 

we would like to audio record our conversation. The recording will only be used to ensure we accurately 

documented your insights. A copy will be provided to you. We will permanently delete the recording after 

this project has ended. 

Our questions are purposefully open-ended; while we have specific question topics we would like to 

discuss, we aspire to have a conversation as opposed to a strict Q&A session. These questions are 

intended to spur the conversation. 

1 Specifically, a two-dimensional barcode printed on the label affixed to the immediate container (i.e., vial, prefilled 

syringe) of a finished vaccine product licensed for sale in the US. 

B-11 
 

 

 

 

 

 

o	 

o	 

o	 

o	 

Information technology, barcode and data exchange standards 

1.	 Please explain the overarching considerations and implications associated with including a twodimensional barcode on a product label. 

2.	 What lessons can we learn from experiences with barcoding in other areas of healthcare, such as 

pharmacies and hospitals? 

3.	 In your opinion, are there areas where the standards are unclear or where there is room for 

different interpretations? Please explain. 

4.	 What non-US regulatory trends affecting labeling and automated vaccine product tracking are 

important for us to understand? What trends in harmonization should we be aware of? 

5.	 Would two-dimensional barcodes have special considerations for the following (and if so how): 

Products with multiple lot numbers 

Any products being alternately labeled as a pharmaceutical or a medical device 

Products produced by one firm but marketed under agreement by another 

Combination vaccines 

6.	 Apart from barcodes, are there any automated identification technologies or strategies used or are 

any such technologies emerging? If so, please explain the pros and cons of such technologies, as 

you understand them. 

7.	 What timeframe would you anticipate being needed to put standards in place to support twodimensional barcoding? 

8.	 Can you provide an overview of the process that would be involved in introducing, formalizing, 

reviewing and publishing standards for two-dimensional barcodes? What other standards bodies 

or groups would refer to or collaborate with? What sorts of resources or tools do you use to 

propose, introduce, review, publish and promote standards (e.g. registries, stakeholder 

collaboration resources)? 

9.	 When thinking about the barcode itself, what data elements would you and your members like to 

see in the code? Have your members expressed preferences or concerns about them? 

10. Vaccine product labels are regulated by FDA, and changes to labels require FDA review and 

approval under 21 CFR 601.12(f). Labels include those on immediate outer packaging and 

wrapping, product labels on immediate containers, and product inserts. 

What FDA requirements, member considerations, and any other standards are relevant for what 

information is presented on labels and how that information is presented? What other standards 

do your members tend to follow? 

11. Are there any backwards compatibility issues or requirements related to switching from onedimensional to two-dimensional barcodes (e.g. legacy software/systems) 

Downstream impacts 

B-12 
 

 

 

 

 

 

o 

o 

o 

o 

o 

We need your assistance in characterizing and understanding downstream impacts of this change. 

12. When considering barcoding, what downstream impacts do you see for providers, registries, 

payers etc? 

13. What would the impact be on different areas that would potentially be affected, such as: 

Internal and external interface planning 

Interface programming and line testing 

Software technology (medical records, registries etc) 

FDA approvals or inspections 

Others? 

14. In your opinion, what do providers and registries need to do to accommodate two-dimensional 

barcoding? What concerns do they need to overcome? 

15. What considerations do you have regarding interoperability of systems? 

16. Would the barcodes be able to be used with patient-centered technologies such as web-based 

interfaces? 

17. How do you anticipate meaningful use criteria being met through the use of two-dimensional 

barcodes? 

Other 

18. Imagine 5 years from now. Do all vaccines have two-dimensional bar codes? If yes, what 

information does the barcode include? If no, why? What else do you see for labeling? 

19. Are there benefits to two-dimensional barcodes that are not commonly addressed? Are there any 

other barriers/concerns about two-dimensional barcodes that we have not yet addressed? 

20. In your opinion, what emerging trends in labeling technology or standards should we review? 

21. In your opinion, what other groups (standards or otherwise) should we talk to? 

22. Is there anything else we did not ask that we should know as we move forward with this effort? 

Thank you very much for your time. We appreciate your help with this important initiative. 

B-13 
APPENDIX C: DOSAGE ESTIMATION METHODOLOGY
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The number of doses expected to be administered in the United States from 2013 to 2033 

was estimated by analyzing data on U.S. population projections (U.S. Census Bureau, 2005; 

2009), vaccination rates among different age groups (CDC, 2010c; CDC, 2009, 2010b), and 

wastage and extraimmunization rates (Setia, 2002; WHO, 2011). Estimates were developed 

in four separate vaccine groups—pediatric, adolescent, adult, and influenza—based on the 

ACIP-recommended immunization schedule as of February 2011 (CDC, 2011). Other 

vaccines such as traveler’s vaccines (i.e., typhoid, yellow fever, anthrax) were not 

estimated. Immunization and series completion rates were assumed to remain stable over 

time. 

The process of estimating the number of doses consisted of three key steps: 

1.	 Acquiring and reviewing the vaccination rate (including series completion rates) for 

each vaccine in each age group. 

2.	 Calculating total number of doses expected to be administered by multiplying 

vaccination rates by the appropriate population estimate.
 

3.	 Multiplying by wastage and extraimmunization to arrive at the total number of 

expected doses. 

C.1 Pediatric Vaccines 

Pediatric vaccination rates are the most complex. Data were gathered from the 2009 

National Immunization Survey, which targets the vaccination history of children aged 19 to 

35 months.1 The survey covers diphtheria and tetanus toxoids and acellular pertussis 

vaccine (DTaP); poliovirus vaccine (polio); measles-containing vaccine (MCV); Haemophilus 

influenzae type b vaccine (Hib); hepatitis B vaccine (Hep B); varicella zoster vaccine, 

pneumococcal conjugate vaccine (PCV), hepatitis A vaccine (Hep A), and influenza vaccine 

(FLU). 

Because most pediatric vaccines consist of multiple doses and not all persons receive the 

complete dose, an expected number of doses was developed for each vaccine using the 

following formula: 

DOSE

∈ = 4 * d4 + 3* Max ((d3 − d4 ),0) + 2 * Max (Min ((d2 − d3 ),(d2 − d4 )),0) +

Max (Min ((d1 − d2 ),(d1 − d3 ),(d1 − d4 )),0) 

where 

1 Source data tables include Estimated Vaccination Coverage for Hepatitis B Vaccine for Children from 

Birth to 3 Days of Age and Estimated Vaccination Coverage with Individual Vaccines by 3 Months, 5 

Months, 7 Months, 13 Months, 19 Months, and 24 Months and Among 19-35 Months of Age. 

Available at http://www.cdc.gov/vaccines/stats-surv/nis/nis-2009-released.htm. 

C-1 
Impact of a Two-Dimensional Barcode 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

DOSE

∈

= Expected doses for each vaccine 

dn = Percentage of target population receiving n doses 

C.2 Adolescent Vaccines 

The data for estimating adolescent vaccines come from the National Immunization SurveyTeen, which gathers data on the percent of teens between the ages of 13 to 19.2 The survey 

asked whether, since the age of 10, these teens had received the meningococcal 

(MenACWY), human papillomavirus (HPV), and combined tetanus, diphtheria and pertussis 

or tetanus and diphtheria (Tdap/Td) vaccines. All vaccines were assumed to be received at 

age 11. HPV rates were only for females so the expected dosage rate was divided in half to 

account for males’ inclusion in the population estimates.3 The estimated HPV vaccination 

rate was calculated using the same methodology as was used in estimating the multi-dose 

pediatrics vaccines. MenACWY and Tdap are single-dose vaccines (not including boosters). 

C.3 Adult Vaccines 

The data on adult vaccinations come from the 2009 National Health Interview Survey (CDC 

2010b).4 Vaccination rates for estimated for Td/Tdap 10-year boosters and the herpes 

zoster (shingles) vaccines. In the survey, adults over age 60 were asked if they had ever 

received the zoster vaccine. For simplicity, it was assumed that all adults received this 

vaccine at age 60. Adult survey respondents were also asked if they had received a Td/Tdap 

booster in the past 10 years. The percentage of adults reporting to have received this 

booster was then divided by 10 to yield an annual vaccination rate. 

C.4 Influenza Vaccines 

Annual influenza vaccinations are administered beginning at six months of age. Data from 

the Behavioral Risk Factor Surveillance System were used to estimate flu vaccination rates 

for all age groups (CDC, 2010a).5 Data was grouped into the following categories: children 

aged 6 months to 17 years, aged 18 to 49 years at high risk, persons aged 18 to 49 years 

not at high risk, persons aged 50 to 64 years, and all persons aged 65 years or older. CDC 

defines high risk as including those suffering from “asthma, other lung problems, diabetes, 

2 Source data table was Estimated Vaccination Coverage With Selected Vaccines Among Adolescents 

Aged 13-17 Years. Available at http://www.cdc.gov/vaccines/stats-surv/nis/nis-2009-released.htm. 3 The ACIP recommended schedule as of February 2011 did not recommend the HPV vaccine for 

males. 4 Source data table was Table 2. Estimated proportion of adults aged >19 years who received selected 

vaccinations, by age group, high-risk status, National Health Interview Survey (NHIS), United 

States, 2009. Available at http://www.cdc.gov/nchs/nhis/nhis_2009_data_release.htm. 5 Source data table was Table 1: Estimated seasonal influenza vaccination coverage among children 

and adults, by U.S. Department of Health and Human Services (HHS) region, state, and selected 

age and risk subgroups—United States, Behavioral Risk Factor Surveillance System (BRFSS) and 

National 2009 H1N1 Flu Survey (NHFS), end of January 2010. Available at 

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5916a1.htm. 

C-2 
Appendix C — Dosage Estimation Methodology 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

heart disease, kidney problems, anemia, or weakened immune system caused by a chronic 

illness or by medicines taken for a chronic illness.” The not at high risk category was used 

for 18- to 49-year-olds because the difference in immunization rates between high and low 

risk was less than 10% at the national level. For the purposes of this study, it was 

determined that the cost of estimating the number of high risk individuals did not outweigh 

the benefit of doing so because it would not materially affect the benefit-to-cost ratio. 

C.5 Total Projections 

Population estimates were gathered from the U.S. Census Bureau. Because state-level 

projections were only available until 2030, state-level data for 2030 to 2033 were 

extrapolated. Total estimated vaccines for each year were calculated by simply multiplying 

the vaccination rates for each age by the estimated population of that age in each year. 

Finally, the number of estimated vaccines was adjusted for wastage and extraimmunization. 

Wastage is defined as “doses discarded from opened vials after the immunization session, in 

accordance with multi-dose opened vial policy (MDVP) or otherwise; Doses damaged in 

unopened vials for any other reasons: e.g. problems with the cold chain (VVM at discard 

point, frozen DTP, TT, or Hep B), expired vaccine batches, broken vials during transport and 

handling; Doses diverted from the target population, i.e. booster doses or doses 

administered to populations outside the targeted group, etc.” (WHO, 2011). Table C-1 

shows the wastage rates by vaccine employed in this analysis. 

Table C-1. Vaccine Wastage Rates 

Vaccine Waste Rate (%) 

DTP 1.7 

Hep A 1.6 

Hep B 1.1 

Hib 2.6 

IPV 1.5 

MMR 1.3 

Td 2.1 

VAR 1.7 

Total 2.6 

Source: Setia, 2002. 

Extraimmunization is defined as having more than the recommended number of doses of 

any vaccine. Specific extraimmunization rates were gathered for polio, DTaP, MMR, Hib, and 

hepatitis B and are displayed in Table C-2. The extraimmunization rate for all other vaccines 

was estimated using the average of the other five. 

C-3 
Impact of a Two-Dimensional Barcode 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table C-2. Extraimmunization Rates among Difference Vaccinesa 

DTaP/DTP 3% 

Polio 4% 

MMR 2% 

Hib 1% 

Hep B 1% 

Otherb 2% 

a Among children at 35 months of age. 

b Estimated as mean of other values. 

Source: CDC, 2007. 

C.6 Sources 

The Centers for Disease Control and Prevention (CDC). (2007). Assessing 

extraimmunization among children using immunization information systems. 

Retrieved from http://cdc.confex.com/cdc/nic2007/techprogram/P12366.HTM 

Centers for Disease Control and Prevention (CDC). (2010a). Interim results: State-specific 

seasonal influenza vaccination coverage—United States, August 2009—January 

2010. Retrieved from 

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5916a1.htm 

Centers for Disease Control and Prevention (CDC). (2010b). National Health Interview 

Survey 2009. Retrieved from http://www.cdc.gov/nchs/nhis/about_nhis.htm 

Centers for Disease Control and Prevention (CDC). (2010c). National Immunization Survey 

2009. Retrieved from http://www.cdc.gov/nchs/nis.htm 

Centers for Disease Control and Prevention. (2011). ACIP recommendations (by Date 

Published). Retrieved from http://www.cdc.gov/vaccines/pubs/ACIP-list-by-date.htm 

Setia, S., et al. (2002). Frequency and causes of vaccine wastage. Retrieved from 

http://www.technet21.org/index.php/documents/view-document/876-frequencyand-causes-of-vaccine-wastage.html 

U.S. Census Bureau. (2005). File 3. Interim state projections of population by single year of 

age: July 1, 2004 to 2030. Retrieved from 

www.census.gov/population/www/projections/files/DownldFile3.xls 

U.S. Census Bureau. (2009). 2009 national population projections (Supplemental). 

Retrieved from 

http://www.census.gov/population/www/projections/2009projections.html 

World Health Organization (WHO). (2011). Projected vaccine wastage. Retrieved from 

http://www.who.int/immunization_delivery/systems_policy/logistics_projected_wast 

age/en/index.html 

C-4 
APPENDIX D: SURVEYMATERIALS
 
 

(You could win an iPad!) 

VFC providers: Take 10 minutes to respond to a CDC 

survey about vaccine barcodes and you could win 1 of 

10 iPads! 

Two-dimensional barcodes could make it easier to collect and 

document information in patients' records. These barcodes 

could contain the manufacturer, product, expiration date, and 

lot number information needed for immunization records. 

Although manufacturers aren't placing them on vaccines yet, 

these barcodes could improve patient safety and record 

keeping. 

Through a contract with the Centers for Disease Control and 

Prevention, RTI International is conducting a 10-minute 

Vaccine Barcoding Survey to learn more about the impact 

that including these barcodes on vaccines would have on 

providers like you. 

Please help us explore the benefits and costs of using twodimensional barcodes by telling us how you think it could 

affect your immunization practice. 

Go now to https://vaccinebarcodingsurvey.rti.org. You can 

enter a raffle to win 1 of 10 iPads as a thank you for sharing 

your perspective!* 

*You will need to know how many doses of childhood, adolescent, adult, 

travelers', and influenza vaccines you give per year before starting the 

survey. This information will improve our ability to understand responses 

we receive, but if this information is not available, please complete the rest 

of the survey. A sample survey is available for download from the website. 

All responses are confidential and will only be used to inform CDC's vaccine 

barcoding study. For questions and comments, contact 

barcodingsurvey@rti.org. 
 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccine Barcoding Survey (Private Medical Practices) 

Thanks for taking the time to respond to the Vaccine Barcoding Survey! This is a version of the 

survey that you can print and use to prepare your response. You must respond to the survey over 

the Internet. The URL is https://vaccinebarcodingsurvey.rti.org. 

To thank you for participating in the survey, you will be entered into a raffle to win 1 of 10 iPads. 

We anticipate notifying winners in early June. 

If you have questions, please contact Fern Braun at 415-848-1370 (US Pacific Time) or send an 

email to barcodingsurvey@rti.org. 

1. Are you a health department or a physician-provider’s medical practice? 

Respondent Profile 

2. What is the 5-digit zip code of your primary or largest practice location? 

• Zip code: 

Proceed to 3 

3. What is your medical specialty? Please select one choice that best represents your primary 

practice. 

• Pediatrics 

• Family practice 

• OB/GYN 

• Internal medicine 

• Other (Specify) 

Proceed to 4 

4. What is the primary setting in which you provide most of your clinical care? Please select one 

choice. 

• Physician office, solo practice 

• Physician office, single specialty group practice 

• Multi-specialty group practice or clinic 

• Teaching hospital 

• Non-Teaching hospital 

• Other (Specify) 

Proceed to 5 
 

 

 

 

 

 

 

5. How many of the following staff are in your practice? If your practice performs immunizations, 

consider the staff involved in the workflow for immunization at your practice. How many of the 

following staff at your practice prepare vaccines and how many administer vaccines? 

Staff positions How many total staff 

are in these positions at 

your practice? 

How many of these 

staff prepare vaccines? 

How many of these staff 

administer vaccines? 

Physicians 

Physicians assistants 

Nurse practitioners 

Registered nurses 

Licensed practical 

nurses 

Medical assistants 

Proceed to 6 

Immunization Activity Measures 

6. Which of the following categories of vaccines does your practice administer? For those vaccine 

types your practice administers, please provide the approximate number of doses administered in a typical 

year. 

Please note that seasonal influenza is covered in a subsequent question. 

Administer 

Yes or No? 

Vaccine Category Approximate number of doses 

administered per year? 

Childhood vaccines 

(e.g., Hep B, Hep A, RV, Dtap, Hib, PCV, 

IPV, MMR, Varicella) 

Adolescent vaccines 

(e.g., Tdap [for adolescents], MCV, HPV) 

Adult vaccines 

(e.g., Tdap [for adults], PPSV, Zoster) 

Travelers’ vaccines 

(e.g., Japanese Encephalitis, Typhoid, 

Yellow Fever, Rabies, etc.) 

Proceed to 7 

7. By the end of the 2010-2011 influenza season, approximately how many doses of seasonal flu do 

you expect your practice will have administered? 

• Doses: 

Proceed to 8 

8. Does your practice participate in the Vaccines for Children (VFC) program? Q8_VFC 

• Yes, I participate in the VFC program. 

• No, I do not participate in the VFC program. 
 

 

 

 

 

 

 

 

 

If yes, proceed to 9; if no, proceed to 10 

9. In a typical year, what percentage of childhood and adolescent vaccine doses administered by 

your practice do you estimate would be VFC doses? 

• Percentage of doses: 

Proceed to 10 

10. In how many of the following work areas in your practice does your staff draw-up or otherwise 

prepare vaccines for administration? 

If the number of staff and the number of doses have been for more than one office location, be sure to 

account for that here. For example, if you have two offices, each with two nurses’ stations, you would 

enter four nurses’ stations. 

Number of locations 

Nurses’ station(s) 

Dedicated room(s) for immunization or laboratory(-es) 

Examination room(s) 

Other(s) 

(specify) 

Proceed to 11 

Existing IT Infrastructure 

11. Does your practice currently use any of the following computer systems or functionalities? 

System Do you have this system? 

(please indicate yes or no 

Electronic medical record system 

Practice management and billing system 

Automated data input devices, such weight scales or blood pressure 

devices 

Barcoding and barcode scanning of any type for medical supplies, 

encounter forms, documentation, etc. 

Other computerized system (specify) 

Other computerized system (specify) 

If no to EMR, go to 12; If yes to EMR go to 13 

12. Although you do not have an electronic medical record system at present, when do you expect 

that you may have a system in use: 

• By the end of 2011 

• By the end of 2012 

• By the end of 2013 

• By the end of 2014 

• By the end of 2015 

• After 2015 

• Not sure or have no plans to adopt 
 

Proceed to 14 

13. Is your electronic medical record system capable of capturing vaccine information such as lot 

number and expiration date? 

• Yes 

• No 

Proceed to 14 

14. In general, what systems or procedures do you have in place to monitor the number of doses that 

you have in stock at your practice? Please select the systems that are used at least monthly. 

System or procedure? Please select 

(Tick mark if yes) 

Comment 

(if any) 

Registry- or Internet-based inventory system 

Inventory software system installed in your practice 

Computerized system that is part of your practice management 

and billing system 

MS Excel spreadsheets or similar files maintained by your staff 

Paper-based systems, such as a ledger 

None; we simply order when the stock looks low 

Other (specify) 

Proceed to 15 

15. Do you report immunizations to your state or local immunization registry? Q15_IIS_REP 

• Yes 

• No 

Proceed to 16 

16. How do you report immunizations provided by your practice to your state or local immunization 

registry? 

Method Do you use this method? Yes or 

No 

Approximate percentage of 

immunizations entered this 

way (on an annual basis) 

Automated upload from 

computer system into registry 

Manual entry of immunization 

records into registry 

Faxes of records to registry 

Other 

(specify) 

Proceed to 17 
 

 

 

 

 

 

 

 

 

 

Perceptions of Two-Dimensional Barcode Utility 

Figure 1: Example of linear barcode 

Current linear barcodes required by the FDA 

contain only the vaccine product identification 

information. 

Figure 2: Example of two-dimensional barcode 

A two-dimensional, or data matrix, barcode can 

include product identification information as well 

as lot number and expiration date. 

17. Consider the following: The American Academy of Pediatrics (AAP) is recommending that labels 

on vaccine vials and syringes have a two-dimensional barcode containing product name, expiration date, 

and lot number (see Figures 1 and 2). 

Rather than have staff read and manually enter this information into records and forms, the information 

could be automatically scanned into your computer systems (patient records, practice management 

system, etc.) using an inexpensive handheld or tabletop reader. You could also use barcodes to track and 

manage vaccine inventory and insure vaccines administered are recorded in your practice management 

and billing system. 

Using barcodes to record vaccine information in patient records may take less time, be more accurate, and 

insure the proper vaccine is being administered. Using barcodes to manage vaccine inventory could 

decrease staff time spent to manually track inventory and could also insure proper billing of all vaccines 

administered. Changes to practices include purchasing scanners, training staff to use the barcode scanners 

which cost about $300), and modifying your computer systems to accept input from the barcode reader. 

Based on this description, do you think your practice would use the barcode? Please select one choice. 

• Yes, my practice would likely use the barcode. 

• My practice would likely use the barcode if we had an electronic medical record system. 

• No, my practice would not likely use the barcode. 

• I do not know if my practice would use the barcode. 

If no to 15 and yes to 17, then go to 18; otherwise go to 19 

18. You indicated that you do not report immunizations to your state or local immunization registry. 

Do you think that vaccines barcoded with product, expiration date, and lot information would make you 

more likely to report immunizations? 

• Yes 

• No 

• Unsure or don’t know 

Proceed to 19 

19. If a vaccine information statement (VIS) included a barcode containing the vaccine type and VIS 

edition date and could be rapidly scanned into a computer system using a handheld or table-top barcode 

reader, do you think your practice would use the VIS barcode? 

• Yes 

• No 
 

 

 

 

 

 

 

 

20 

Proceed to 20 

What kinds of assistance do you think your practice would need to start to use the twodimensional barcode that will be on vaccine labels? Please select all that apply. 

• Software support for integration with electronic medical record system 

• Software support for integration with practice management and billing systems 

• Software development for integration with your state or local immunization registry 

• Guidance for integration of the barcode into your practice’s workflow for immunization 

• Staff training 

• Scanner selection and installation 

• Other (Specify) 

Proceed to 21 

21. How important is each of the following factors likely to be in your decision about whether to 

implement barcode scanning to capture vaccine product, expiration date, and lot number information? 

Unimportant Somewhat 

unimportant 

Neutral Important Very 

important 

Cost of scanner(s) 

Possible changes to workflow 

Training 

Reliability of the barcodes 

Readability of the barcodes 

Usability of the barcode scanners 

Increased accuracy of records 

Decreased time spent recording 

vaccine information and/or 

documenting immunization 

More efficient and accurate 

management of inventory 

Potential decrease in the number of 

vaccines that do not get billed to a 

private payer 

Proceed to 22 

22. Do you have specific comments or concerns about the acceptability or potential for using twodimensional barcode scanning in your practice? 

Proceed to 23 

23. How did you hear about this survey? 

• Email 

• Postcard 

• Newsletter 

• Word of mouth 

• Other (Specify) 
Proceed to 24 

24. Thank you for completing our survey. If you would like to be entered into the raffle for the 

chance to receive 1 of 10 iPads, please provide your contact information. 

• Name: 

• Address: 

• Email: 

• Telephone number: 
 

 

 

 

 

 

 

 

Vaccine Barcoding Survey (Local Health Departments) 

Thanks for taking the time to respond to the Vaccine Barcoding Survey! This is a version of the 

survey that you can print and use to prepare your response. You must respond to the survey over 

the Internet. The URL is https://vaccinebarcodingsurvey.rti.org. 

To thank you for participating in the survey, you will be entered into a raffle to win 1 of 10 iPads. 

We anticipate notifying winners in early June. 

If you have questions, please contact Fern Braun at 415-848-1370 (US Pacific Time) or send an 

email to barcodingsurvey@rti.org. 

1. Are you a health department or a physician-provider’s medical practice? 

Respondent Profile 

2. What is the 5-digit ZIP code of your health department’s location? If your health department has 

more than one location, please use the ZIP code for your main location. 

• Zip Code: 

Proceed to 3 

3. How would you characterize your health department’s organization? 

• State health department 

• County health department 

• City health department 

• Territorial or tribal health department 

• Other (Specify) 

Proceed to 4 

4. How many of the following staff are in your health department? If your practice performs 

immunizations, consider the staff involved in the workflow for immunization at your practice. How many 

of the following staff prepare vaccines and how many administer vaccines? 

Staff positions How many total staff 

are in these positions at 

your health department? 

How many of these 

staff prepare vaccines? 

How many of these staff 

administer vaccines? 

Physicians 

Physicians assistants 

Nurse practitioners 

Registered nurses 

Licensed practical 

nurses 

Medical assistants 

Proceed to 5 
 

 

 

 

 

 

Immunization Activity Measures 

5. Which of the following categories of vaccines are administered in your immunization clinics? For 

those vaccine categories administered, please provide the approximate number of doses administered in a 

typical year. 

Please note that seasonal influenza is covered in a subsequent question. 

Vaccine Category Administer this category of 

vaccine? 

Approximate 

number of doses 

administered per 

year? 

Childhood vaccines 

(e.g., Hep B, Hep A, RV, Dtap, Hib, PCV, 

IPV, MMR, Varicella) 

Adolescent vaccines 

(e.g., Tdap (for adolescents), MCV, HPV) 

Adult vaccines 

(e.g., Tdap (for adults), PPSV, Zoster) 

Travelers’ vaccines 

(e.g., Japanese Encephalitis, Typhoid, 

Yellow Fever, Rabies, etc.) 

Proceed to 6 

6. By the close of the 2010-2011 influenza season approximately how many doses of seasonal flu do 

you expect will have been administered in your clinics? 

• Doses: 

Proceed to 7 

7. In how many of the following locations are vaccines drawn-up or otherwise prepared for 

administration? 

If the number of staff and the number of doses have been for more than one office location, be sure to 

account for that here. For example, if you have two different offices, each with two nurses’ stations, you 

would enter for nurses’ stations. 

Location Number of locations (Please 

indicate below) 

Nurses’ station(s) 

Dedicated room(s) for immunization or laboratory(-es) 

Examination room(s) 

Other(s) 

(specify) 

Proceed to 8 

D-10
 

 

 

 

 

 

 

 

 

 

 

 

Existing IT Infrastructure 

8. Does your health department currently use any of the following computer systems or 

functionalities? 

System Do you have this system? 

Electronic medical record system 

Health department management and billing system 

Automated data input devices, such as weight scales or blood pressure 

devices 

Barcoding and barcode scanning of any type for medical supplies, 

encounter forms, documentation, etc. 

Other computerized system 

(specify) 

Other computerized system 

(specify) 

If no to EMR, go to 9; If yes to EMR go to 10 

9. Although you do not have an electronic medical record system at present, when do you expect 

that you may have a system in use: 

• By the end of 2011 

• By the end of 2012 

• By the end of 2013 

• By the end of 2014 

• By the end of 2015 

• After 2015 

• Not sure or have no plans to adopt 

Proceed to 11 

10. Is your electronic medical record system capable of capturing vaccine information such as lot 

number and expiration date? 

• Yes 

• No 

Proceed to 11 
 

 

11. In general, what systems or procedures do you have in place to monitor the number of doses that 

you have in stock for your immunization clinic(s)? Please select the systems that are used at least 

monthly. 

Systems or Procedures? Do you use this 

system or 

procedure? 

Comment 

(if any) 

Registry- or Internet-based inventory system 

Inventory software system installed in your health department 

Computerized system that is part of your health department 

management and billing system 

MS Excel spreadsheets or similar files maintained by your staff 

Paper-based systems, such as a ledger 

None; we simply order when the stock looks low 

Other (Specify) 

Proceed to 12 

12. Do you report immunizations provided in your health department’s immunization clinic(s) to a 

state immunization registry? 

• Yes 

• No 

If yes, proceed to 13; if no, proceed to 14 

13. How do you report immunizations provided by your health department’s immunization clinic(s) 

to your state immunization registry? 

Method Do you use this method? 

Yes or No 

Approximate percentage of 

immunizations entered this 

way (on an annual basis) 

Automated upload from 

computer system into registry 

Manual entry of immunization 

records into registry 

Faxes of records to registry 

Other 

(specify) 

Proceed to 14 
 

 

 

 

 

 

 

 

Perceptions of Two-Dimensional Barcode Utility 

Figure 1: Example of linear barcode 

Current linear barcodes required by the FDA 

contain only the vaccine product identification 

information. 

Figure 2: Example of two-dimensional barcode 

A two-dimensional, or data matrix, barcode can 

include product identification information as well 

as lot number and expiration date. 

14. Consider the following: The American Academy of Pediatrics (AAP) is recommending that labels 

on vaccine vials and syringes have a two-dimensional barcode containing product name, expiration date, 

and lot number (see Figures 1 and 2). 

Rather than have staff read and manually enter this information into records and forms, the information 

could be automatically scanned into your computer systems (patient records, practice management 

system, etc.) using an inexpensive handheld or tabletop reader. You could also use barcodes to track and 

manage vaccine inventory and insure vaccines administered are recorded in your practice management 

and billing system. 

Using barcodes to record vaccine information in patient records may take less time, be more accurate, and 

insure the proper vaccine is being administered. Using barcodes to manage vaccine inventory could 

decrease staff time spent to manually track inventory and could also insure proper billing of all vaccines 

administered. Changes to practices include purchasing scanners, training staff to use the barcode scanners 

which cost about $300), and modifying your computer systems to accept input from the barcode reader. 

Based on this description, do you think your health department’s immunization clinic(s) would use the 

barcode? 

•	 Yes, my health department’s immunization clinic(s) would likely use the barcode. 

•	 My health department’s immunization clinic(s) would likely use the barcode if we had an 

electronic medical record system.
 

•	 No, my health department’s immunization clinic(s) would not likely use the barcode. 

•	 I do not know if my health department’s immunization clinic(s) would use the barcode. 

If no to 12 and yes to 14, then go to 15; otherwise go to 16 

15. You indicated that you do not report immunizations to an immunization registry. Do you think 

that vaccines barcoded with product, expiration date, and lot information would make you more likely to 

report immunizations to the registry? 

•	 Yes 

•	 No 

•	 Unsure or don’t know 

Proceed to 16 
 

 

 

 

 

 

 

 

 

 

17 

16. If a vaccine information statement (VIS) included a barcode containing the vaccine type and VIS 

edition date and this information could be rapidly scanned into a computer system using a handheld or 

table-top barcode reader, do you think your health department may use the barcode? L16_VIS 

• Yes 

• No 

Proceed to 17 

What kinds of assistance do you think your health department would need to start to use the twodimensional barcode that will be on vaccine labels? 

• Software support for integration with electronic medical record system 

• Software support for integration with health department management and billing systems 

• Software support for integration with immunization registry 

• Guidance for integration of the barcode into your health department’s workflow for immunization 

• Staff training 

• Scanner selection and installation 

• Other (Specify) 

Proceed to 18 

18. How important is each of the following factors likely to be in your decision about whether to 

implement barcode scanning to capture vaccine product, expiration date, and lot number information? 

Factors Unimportant Somewhat 

unimportant 

Neutral Important Very 

important 

Cost of scanner(s) 

Possible changes to workflow 

Training 

Reliability of the barcodes 

Readability of the barcodes 

Usability of the barcode scanners 

Increased accuracy of records 

Decreased time spent recording 

vaccine information and/or 

documenting immunization 

More efficient and accurate 

management of inventory 

Potential decrease in the number of 

vaccines that do not get billed to a 

private payer 

Proceed to 19 

19. Do you have specific comments or concerns about the acceptability or potential for using twodimensional barcode scanning in your health department’s immunization clinic(s)? 

Proceed to 20 
20. How did you hear about this survey? 

• Email 

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Proceed to 21 

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chance to receive 1 of 10 iPads, please provide your contact information. We will notify winners by 

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APPENDIX E: RESPONSE COUNT BY VFC JURISDICTION
 
 

 

 

 

 

 

 

Using the USDA Rural-urban Continuum Code (RUCC) (USDA, 2004), we assigned 

respondent counties as either a county in a metro area or a nonmetro county. Based on 

these RUCC classifications, 82% of provider respondents were located in metro areas, while 

55% of LHD respondents were located in metro areas (Table E-1). To map respondents, we 

aggregated responses based on the first four digits of the supplied zip code. 

Table E-1. Number of Responses by VFC Jurisdiction 

Providers LHDs 

Metro 

(RUCC 

codes) 

Nonmetro 

(RUCC 

codes) 

Number of 

Responses 

(LHDs) 

Metro 

(RUCC 

codes) 

Nonmetro 

(RUCC 

codes) 

Number of 

Area Participated Responses 

Alabama No response 5 5 0 1 1 0 

Alaska Declined 3 2 1 0 0 0 

American Samoa No response 0 NA NA 0 NA NA 

Arizona Yes 48 41 7 5 4 1 

Arkansas Yes 24 15 9 0 0 0 

California Yes 124 119 5 12 9 3 

Chicago Yes 35 35 0 5 5 0 

Colorado Yes 74 55 19 23 10 13 

Connecticut Yes 65 62 3 10 10 0 

Delaware Yes 10 6 4 4 3 1 

District of Columbia Yes 4 4 0 0 0 0 

Florida Yes 199 190 9 7 6 1 

Georgia Yes 19 19 0 0 0 0 

Guam No response 0 NA NA 0 NA NA 

Hawaii Declined 3 3 0 0 0 0 

Houston Declined 40 40 0 3 3 0 

Idaho Yes 11 7 4 2 0 2 

Illinois Declined 27 23 4 2 0 2 

Indiana Yes 15 14 1 13 10 3 

Iowa Declined 4 3 1 1 1 0 

Kansas Yes 50 33 17 88 21 67 

Kentucky Yes 41 20 21 42 19 23 

Louisiana Yes 31 21 10 15 10 5 

Maine No response 7 4 3 0 0 0 

Maryland No response 9 8 1 0 0 0 

Massachusetts Yes 170 170 0 55 54 1 

Michigan Yes 206 162 44 37 23 14 

Minnesota No response 6 6 0 1 0 1 

Mississippi Declined 0 0 0 0 0 0 

Missouri Yes 6 5 1 80 25 55 

Montana Declined 0 0 0 1 1 0 

Nebraska Yes 57 34 23 8 2 6 

Nevada Yes 4 4 0 0 0 0 

New Hampshire Declined 2 1 1 0 0 0 

(continued) 

E-1 
 

 

 

 

Impact of a Two-Dimensional Barcode 

Table E-1. Number of Responses by VFC Jurisdiction (continued) 

Providers LHDs 

Metro 

(RUCC 

codes) 

Nonmetro 

(RUCC 

codes) 

Number of 

Responses 

(LHDs) 

Metro 

(RUCC 

codes) 

Nonmetro 

(RUCC 

codes) 

Number of 

Area Participated Responses 

New Jersey Yes 72 72 0 26 26 0 

New Mexico No response 5 3 2 0 0 0 

New York City Yes 81 81 0 2 2 0 

New York State Yes 35 32 3 3 3 0 

North Carolina Yes 83 63 20 39 23 16 

North Dakota Yes 14 6 8 15 0 15 

Northern Mariana No response 0 NA NA 0 NA NA 

Islands 

Ohio Yes 81 69 12 38 24 14 

Oklahoma No response 3 2 1 0 0 0 

Oregon Yes 111 70 41 24 9 15 

Pennsylvania Yes 87 72 15 5 2 3 

Philadelphia Yes 57 57 0 10 10 0 

Puerto Rico Yes 4 NA NA 12 NA NA 

Rhode Island No response 0 0 0 0 0 0 

San Antonio Declined 7 7 0 0 0 0 

South Carolina Yes 93 65 28 15 10 5 

South Dakota Yes 54 29 25 27 5 22 

Tennessee No response 9 8 1 0 0 0 

Texas Yes 435 350 85 119 81 38 

Utah Yes 58 53 5 13 10 3 

Vermont No response 4 1 3 0 0 0 

Virgin Islands No response 0 NA NA 0 NA NA 

Virginia Yes 76 64 12 42 28 14 

Washington Declined 10 9 1 2 2 0 

West Virginia Yes 81 41 40 32 14 18 

Wisconsin No response 6 5 1 2 2 0 

Wyoming Yes 10 4 6 10 1 9 

Total 2,775 2,274 497 851 469 370 

Source: RTI International. 

References 

U.S. Department of Agriculture, Economic Research Service. (2004). 2003 rural-urban 

continuum codes. Retrieved from http://www.ers.usda.gov/data-products/ruralurban-continuum-codes.aspx 

E-2 
APPENDIX F: TIME–MOTION STUDY
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

This appendix reviews a time–motion study conducted by the Verden Group (Nyack, NY) the 

data for which were analyzed by RTI International to determine the potential time savings 

associated by eliminating some documentation steps. 

In 2009, the Verden Group performed a study of private practices’ immunization business, 

including a time–motion study of immunization workflow covering ordering, inventory 

management, administration, record keeping, and billing. It recruited 36 practices to 

participate in the study, selecting practices to make the study as representative of the 

administration of pediatric and adolescent doses as possible. Selection criteria included size 

(number of physicians), urban/suburban/rural, specialty, EHR use, and annual number of 

doses administered. Of 36 practices, 3 were used to pilot and refine protocols; the time– 

motion data used in this analysis were from the remaining 33 practices (see Table 7-1). 

The resulting study data included activity-specific estimates for the administration of 724 

vaccines to 302 patients (cases) at 33 practices (30 pediatric practices, 3 family practices) 

across 17 states. RTI International purchased the time–motion data for multiple practices in 

lieu of conducting a study in just one practice. See also Table F-1. 

Immunization workflow can be grouped into eight separate steps necessary for vaccine 

administration (Table F-2). For the purposes of our analysis, based on interviews, we expect 

the vaccine barcode will be read during the “Draw Vaccine” component of Step 5, and the 

time savings will result from reduced time spent documenting the vaccination (Step 8). 

To provide the most accurate estimate of time per dose, RTI weighted each sample case by 

the number of doses received and the annual number of doses administered by the practice 

(Equation F.1).1 

CaseVax 

Weight ij = Nj 

ij × AnnualVax j (F.1) 

∑ CaseVax nj nj =1 

where 

Weightij Weight for sample case i in practice j. 

CaseVaxij Number of vaccinations given to sample case i. 

Nj 

CaseVax ∑ nj Total number of vaccinations administered to sample cases in practice j. ni =1 

AnnualVax j Total number of vaccines administered annually in practice j. 

1 Missing data were handled in a variety of ways. For many cases, Verden Group estimated the time 

for unobserved activities using the per-dose time of observed cases at the same practice. For 

missing data not estimated by the Verden Group, RTI used the weighted per-dose mean for the 

activity within the practice. If a practice was missing data for an entire activity, RTI used the 

weighted per-dose mean across all practices to replace the missing values. Unique weighted perdose means were estimated separately for practice size and EHR to replace missing values when 

analyzing times for process steps by practice size and EHR. 

F-1 
 

 

005

 

010

015

 

020 

 

 

 

025 

 

030

035

 

 

Impact of a Two-Dimensional Barcode 

Table F-1. Attributes of Practices Included in Time-Motion Study 

Practice Total Annual 

Practice State Area Sizea Practice Type EHR? Vaccinations 

003 IL Suburban Small Pediatrician Yes 4,073 

004 NJ Suburban Large Pediatrician No 14,463 

NY Suburban Large Pediatrician No 7,850 

006 MA Suburban Solo Pediatrician Yes 2,080 

007 RI Urban Large Pediatrician Yes 13,336 

008 RI Suburban Small Pediatrician Yes 9,215 

009 CT Suburban Small Pediatrician Yes 10,208 

FL Suburban Large Pediatrician No 19,480 

011 TX Urban Solo Pediatrician Yes 3,446 

012 NY Suburban Large Pediatrician No 10,950 

013 CT Suburban Large Pediatrician Yes 111,524 

014 NJ Suburban Small Pediatrician No 9,878 

PA Suburban Large Pediatrician No 34,557 

016 PA Suburban Small Pediatrician No 8,410 

017 VA Suburban Large Pediatrician Yes 23,500 

018 VA Suburban Small Pediatrician Yes 19,115 

019 NV Suburban Small Family Practice Yes 1,262 

NV Suburban Solo Pediatrician Yes 2,616 

021 CA Suburban Solo Pediatrician Yes 7,774 

022 NV Urban Solo Pediatrician Yes 8,178 

023 OH Suburban Solo Pediatrician No 2,223 

024 OH Suburban Solo Pediatrician Yes 7,937 

NY Urban Large Family Practice Yes 3,240 

026 OK Suburban Small Family Practice Yes 1,868 

027 OK Urban Small Pediatrician No 13,567 

028 FL Suburban Large Pediatrician No 6,549 

029 NC Suburban Large Pediatrician No 4,708 

TN Rural Small Pediatrician Yes 10,152 

031 NY Suburban Large Pediatrician Yes 12,509 

032 NC Suburban Large Pediatrician Yes 23,451 

033 MO Urban Large Pediatrician Yes 24,527 

034 CA Suburban Large Pediatrician No 13,815 

PA Suburban Large Pediatrician Yes 12,157 

a Solo (S) practices have 1–1.5 full-time physicians, small practices (S) have 2–7 full-time physicians, 

and large practices (L) have 8 or more full-time physicians. Source: The Verden Group for RTI 

International. 

EHR (electronic health record) 

F-2 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table F-2. Vaccine Administration Process 

Data Collection 

Step in Timeline Resource Used Process Involved Tool/Section/Field How Time Was Calculated 

1 (or just prior to 4) Nurse (MA, LPN, RN) Nurse or provider reviews Observed vaccine Timed start and end of review 

At the beginning of process or 

process prior to patient visit or 

just prior to being “roomed”/ 

set up or just prior to provider 

seeing patient in room 

or 

Provider (Physician/ 

NP/PA) 

patient chart to see if vaccines 

are up to date or if any are 

missing. Involves reading chart 

and looking up vaccine history. 

administration 

form/Documentation and 

time > Record review 

process, including reading chart 

information and communication 

between nurse and provider about 

when patient should be brought 

current 

2 (or just prior to 5) Nurse (MA, LPN, RN) Nurse provides patient with a Observed vaccine Timed nurses pulling VIS forms 

This sometimes occurred when Vaccine Information Sheet administration from file drawers, printing VIS 

patient was being set up for 

the visit in the exam room, 

other times occurred just prior 

to nurse (or provider) giving 

the vaccine to patient 

(VIS) prior to patient receiving 

vaccine. VIS explains risks and 

benefits. Patients must be 

provided with this information 

to obtain consent. 

form/None/None (recorded 

free hand on form) 

sheet, or locating copy of VIS from 

other places 

3 Provider (Physician/ Provider counsels patient and Observed vaccine Timed in-room discussion with 

NP/PA) obtains consent (occurs in administration form/In room: patient about vaccine only 

room, provider explains vaccine Time and supplies > 

risks and benefits) Counseling 

4 Provider (Physician/ Provider gives order (either Observed vaccine Timed start and end of writing, 

NP/PA) through verbal, written, or EHR administration form/Orders inputting, or verbalizing order to 

methods) given > Time > By nurse 

5 Nurse (MA, LPN, RN) Nurse draws up/prepares Observed vaccine Two sets of timing 

vaccines. This may include 

drawing vaccine into syringes, 

reconstitution of vaccine, 

adding needle tip to prefilled 

syringes, etc. 

administration form > In lab: 

Time and supplies > Time to 

set up tray and total draw 

time 

For tray: timed gathering of 

supplies (bandaids, cotton, etc.) 

For drawing: timed from “hand on 

fridge handle” through all vaccines 

being ready on tray for dispensing. 

Each vaccine product draw time 

was timed separately 

6 Nurse (MA, LPN, RN) Nurse or provider positions Observed vaccine Timed from nurse/provider reor patient and administers the administration form > In entering the exam room through all 

Provider (Physician/ vaccine(s) room: Time and supplies > vaccines being administered 

NP/PA) Giving vaccine physically 

Appendix F — Time–Motion Study 

(continued) 

F-3 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table F-2. Vaccine Administration Process (continued) 

Data Collection 

Step in Timeline Resource Used Process Involved Tool/Section/Field How Time Was Calculated 

7 Nurse (MA, LPN, RN) Nurse or provider Observed vaccine Timed from nurse/provider 

or 

Provider (Physician/ 

NP/PA) 

removes/disposes of needles 

and syringe and/or product 

packaging (vials, tubes, etc.) in 

appropriate receptacle 

administration form > Clean 

up time 

concluding the administration (if 

sharps containers were in room) 

through exiting the room and 

disposing of sharps and product 

containers in lab 

8 Nurse (MA, LPN, RN) Nurse and/or provider Observed vaccine Timed from nurse/provider 

and/or 

Provider (Physician/ 

NP/PA) 

documents administration (if 

provider wrote orders, likely 

does not have to chart anything 

further unless patient had 

administration form > 

Documentation and time > 

chart note and patient card 

(optional) and PM system (if 

entering data into a chart or 

repository through completion (no 

further handling required) 

specific concerns). Nurse must inventory is tracked that 

record vaccine site that vaccine way) and in log book (if 

was administered (e.g., right inventory tracked that way) 

thigh), lot number, vaccine and in vaccine registry (if 

product and type, and date of electronic submission is not 

administration. Documentation available and it is mandatory) 

may also occur in several other 

places depending on process 

and protocol. 

Nurse (MA, LPN, RN) Reporting administered Estimated: Record keeping Some practices had observed time, 

or vaccines to city and/or state Survey interview > Reporting others provided estimates. For 

Office Manager registries. Involves either > Registry observed time, if resources logged 

or manually entering data into and/or data to registry at same time as 

Provider (Physician/ registry databases or Observed: Observed vaccine administration, they were timed 

NP/PA) submitting data electronically administration from log on to registry through 

via an interface between PM form/documentation and completion of fields in database 

system and registry. Time > Free form notes and log off/file save 

Impact of a Two-Dimensional Barcode 

Source: The Verden Group for RTI International. 

MA (medical assistant), LPN (licensed practical nurse), RN (registered nurse), NP (nurse practitioner), PA (physician’s assistant), VIS (Vaccine Information 

Sheet), EHR (electronic health record), PM (practice management) 

F-4 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Appendix F — Time–Motion Study 

Vaccine administration2 required less than 4 minutes (221 seconds) on average (Table F-3). 

Average times at each practice ranged between 1.5 minutes (92 seconds) and over 7 

minutes (427 seconds). 

Table F-3. Average Time per Process Step by Practice 

Annual Process Step 

Practice Vaccines Size EHR 1 3 4 5 6 7 8 Total 

003 4,073 S Y 0.0 67.1 17.6 42.5 31.3 7.2 44.1 209.7 

004 14,463 L N 0.0 15.1 5.8 37.6 21.8 0.0 56.9 137.2 

005 7,850 L N 0.0 33.9 6.5 51.0 26.1 4.1 51.1 172.6 

006 2,080 SO Y 0.0 41.7 3.8 81.3 32.1 0.0 20.3 179.2 

007 13,336 L Y 0.0 46.1 1.5 45.0 22.2 0.0 18.5 133.3 

008 9,215 S Y 0.0 137.9 4.3 119.3 41.0 0.0 124.0 426.5 

009 10,208 S Y 0.0 36.8 5.0 141.0 41.5 0.0 38.3 262.6 

010 19,480 L N 0.0 33.9 0.0 118.6 33.6 0.0 22.2 208.2 

011 3,446 SO Y 0.0 13.2 1.3 55.6 10.3 0.0 12.0 92.4 

012 10,950 L N 0.0 45.0 3.4 55.6 38.5 0.0 69.4 211.9 

013 111,524 L Y 0.0 69.7 4.4 48.4 41.2 8.4 71.5 243.5 

014 9,878 S N 0.0 75.9 4.2 51.1 25.1 5.0 56.6 217.9 

015 34,557 L N 0.0 31.6 24.7 47.2 34.0 3.9 64.7 206.1 

016 8,410 S N 0.0 54.4 7.5 68.9 28.0 6.1 111.8 276.7 

017 23,500 L Y 0.0 26.3 13.9 73.8 25.4 13.1 57.1 209.6 

018 19,115 S Y 19.5 35.5 0.0 44.9 44.3 4.1 21.0 169.3 

019 1,262 S Y 0.0 78.0 9.8 68.4 57.8 6.4 201.4 421.8 

020 2,616 SO Y 24.1 41.5 0.0 75.6 49.7 7.4 74.6 272.9 

021 7,774 SO Y 0.0 47.3 4.6 47.3 16.1 8.1 57.0 180.3 

022 8,178 SO Y 24.9 57.2 12.3 35.7 20.1 7.0 61.3 218.4 

023 2,223 SO N 0.0 29.1 3.4 82.1 77.9 13.1 66.3 271.9 

024 7,937 SO Y 50.5 71.3 17.4 39.2 40.3 6.3 71.9 296.8 

025 3,240 L Y 18.1 77.1 9.5 100.9 44.7 10.2 65.8 326.3 

026 1,868 S Y 24.9 29.5 23.1 67.4 58.1 7.7 151.9 362.6 

027 13,567 S N 0.0 43.6 3.3 55.0 34.7 4.6 77.2 218.4 

028 6,549 L N 0.3 49.6 15.6 97.0 31.1 4.7 59.0 257.3 

029 4,708 L N 8.1 35.4 6.2 55.4 29.6 9.7 138.3 282.7 

030 10,152 S Y 4.4 17.8 15.0 66.6 35.6 5.5 64.5 209.5 

031 12,509 L Y 0.0 37.2 13.3 94.1 56.9 4.3 35.7 241.5 

032 23,451 L Y 0.0 13.5 0.0 43.2 23.5 4.5 103.3 188.0 

033 24,527 L Y 2.8 30.9 15.0 71.1 24.6 5.5 46.1 196.0 

034 13,815 L N 2.3 36.0 7.6 37.0 20.8 5.5 53.9 163.0 

035 12,157 L Y 1.7 89.9 15.0 47.4 28.2 3.5 68.3 254.0 

Average 2.9 48.1 8.0 59.9 33.9 5.5 62.9 221.0 

a Solo (S) practices have 1–1.5 full-time physicians, small practices (S) have 2–7 full-time physicians, and large 

practices (L) have 8 or more full-time physicians. EHR (electronic health record) Source: The Verden Group for 

RTI International. 

2 Excludes time spent providing patient the Vaccine Information Sheet (process Step 2). 

F-5 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Impact of a Two-Dimensional Barcode 

The longest process step was the documentation taking place after the vaccine was 

administered at 62.9 seconds, accounting for 28% of the labor time. Record keeping was 

disaggregated into documentation that is not expected to be eliminated by using 2D 

barcodes (chart notes, VFC usage sheets [which vary by VFC jurisdiction], superbill, other 

[including parental signatures]) and documentation that could be eliminated by 2D barcodes 

(logbooks, entry of vaccine details). Documentation that would not be affected amounted to 

19.2 seconds. 

The amount of time expended on documentation that could be eliminated was 43.7 seconds 

per dose at practices with EHRs and 40.8 seconds per dose at practices without EHRs (Table 

F-4). Scanning a vial takes 4.3 seconds on average, according to the Canadian inventory 

pilot (Pererira & Bishai, 2010).3 Thus, we expect that practices with EHRs will save 

approximately 39.4 seconds per dose and practices without EHRs will save about 36.5 

seconds per dose. 

3 The 95% CI is 3.5 to 5.2 seconds per acceptable scan; includes 1.3 attempts per vial to get a good 

read. 

F-6 
 

 

 

 

 

 

 

 

 

 

Appendix F — Time–Motion Study 

Table F-4. Estimated Change in Documentation Time per Dose, with and without 

an EHR System 

Change in Documentation Time 

Relative to Baseline 

Baseline With EHR No EHR 

Unchanged documentation steps 

Chart notes for immunization 8.0 - -

VFC usage sheets 0.3 - -

Superbill 1.4 - -

Other 9.6 - -

Subtotal 19.2 19.2 19.2 

Affected documentation steps 

Private dose administration logbook 1.5 −1.5 −1.5 

Recording product, expiration date, 

and lot... 

...in patient records 26.7 −26.7 −26.7 

...in practice management system 8.5 −8.5 −8.5 

...in IIS 4.7 −4.7 −4.0 

...in EHR data fields 2.2 −2.2 0.0 

Subtotal 43.7 −43.7 −40.8 

2D barcode scan time +4.3 +4.3 

Total estimated documentation time 62.9 23.5 26.4 

Change in documentation time −39.4 −36.5 

Percentage change in documentation time −63% −58% 

Source: RTI analysis of time–motion study data acquired from the Verden Group, except for barcode 

scan time, which was Pereira et al. (2010). 

EHR (electronic health record), VFC (Vaccines for Children), IIS (immunization information system) 

F-7 
APPENDIX G: DATA MAPPING
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The purpose of these tables is to provide mapping across standards for 2D barcoding. Table 

G-1 outlines the purpose of each table. 

Table G-1. Introduction 

Table Name Purpose 

Data Mapping Includes the most comprehensive mapping across standards. For each 

standard, it includes the data content with each identifier, data type, data 

format, data field length, and position of each element in the standard 

Data Mapping— Is a subset of the data in the data mapping table. Whereas the data 

Specific Data mapping table includes information such as headers and footers, this table 

contains only the GTIN, lot number, and expiration date and how those 

pieces of information would be mapped across standards 

Researcher Notes Includes a summary of the NDC-GTIN mapping issue, notes for HL7, and a 

pictorial view of how elements from the GTIN are mapped to the NDC 

Mapping—GTIN-NDC- Outlines the relationship between the GTIN, NDC, CVX, and MVX to 

CVX_MVX demonstrate how mapping tables might work 

Health Care—GS1-128 Summarizes the application identifiers used in the GS1 standard 

X12 Formatting Provides an example of how the barcode would work using an X12 

Example message for drug billing 

Abbreviations Lists commonly used abbreviations 

Summary Table Is a summary table based on data mapping—specific data 

G-1 
 

 

 

— f

 

 

 

 

 

 

 

 

 

 

Table G-2. Data Mapping for Vaccine Barcodes 

This table has the most comprehensive mapping across standards. For each standard, it includes the data content with each identifier, data type, data format, data field 

length, and position of each element in the standard. 

Impact of a Two-Dimensional Barcode 

Legend: GTIN = Similar data content 

Lot number = Similar data content 

Expiration date = Similar data content 

GS1 

HL7—RXA Message Segment 

HL7 Vaccine Administration Data (Pharmacy/Treatment Administration) CDC 2.5.1 Implementation Guide X12—837 P Transaction HITSP Immunization Message Component Pharmacy EDI

g 

Application 

Identifiers Format Data Content SEQ LEN DT ITEM # Data Content SEQ LEN DT Data Content LEN DT Data Content SEQ LEN DT Data Content Notes LEN DT Data Content Notes LEN DT Data Content Notes 

Header Organization 

name, corporate 

logo, and GLN 

number of the 

producer 

1 4 NM 00342 Give sub-ID 

counter 

1 NM Give sub-ID 

counter 

4 NM Give sub-ID 

counter 

1 5 NM Labeler code The first five 

digits identify the 

manufacturer of 

the drug and are 

assigned by the 

Food and Drug 

Administration 

NM Substance lot 4–5 NM Labeler code Follows NDC 

number format 

Header Product 

description (e.g., 

brand / quality / 

age ref/ size / 

number in case / 

% ABV) 

2 4 NM 00344 Administration 

sub-ID counter 

2 DTM Administration 

sub-ID counter 

4 NM Administration 

sub-ID counter 

2 4 NM Product 

segment 

It identifies the 

strength, dosage 

form, and 

formulation 

Substance 

manufacturer 

Follows HL7 3–4 NM Product 

segment 

Follows NDC 

format 

0 n2 + n18 SSCC (serial 

shipping container 

code) 

3 26 TS 00345 Date/time start of 

administration 

3 DTM Date/time start 

of administration 

26 TS Date/time start of 

administration 

3 2 NM Package 

segment 

It identifies 

package size 

Administered 

code 

Follows HL7. This 

field identifies the 

medical 

substance 

administered. If 

the substance 

administered 

is a vaccine, CVX 

codes should be 

used in the first 

triplet to code this 

field (see HL7 

Table 0292— 

Codes 

for vaccines 

administered). 

1–2 NM Package 

segment 

Follows NDC 

format 

1 n2 + n14 Global Trade Item 

Number (GTIN) 

4 26 TS 00346 Date/time end of 

administration 

4 DTM Date/time end of 

administration 

26 TS Date/time end of 

administration 

Administration 

notes 

Free text notes 

from the provider 

administering the 

medication. 

2 n2 + n14 GTIN of contained 

trade items 

5 100 CE 00347 Administered 

codea 

5 CWE Administered 

code 

100 CE Administered 

code 

10 n2 + X..20 Batch or lot 6 20 NM 00348 Administered 

amount 

6 NM Administered 

amount 

20 NM Administered 

number amount 

11 (**) n2 + n6 Production date 

(YYMMDD) 

7 60 CE 00349 Administered 

units 

7 CWE Administered 

units 

60 CE Administered 

units 

G-2 
—

f

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Appendix G — Data Mapping 

Legend: GTIN = Similar data content 

Lot number = Similar data content 

Expiration date = Similar data content 

GS1 

HL7—RXA Message Segment 

HL7 Vaccine Administration Data (Pharmacy/Treatment Administration) CDC 2.5.1 Implementation Guide X12—837 P Transaction HITSP Immunization Message Component Pharmacy EDI

g 

12 (**) n2 + n6 Due date 

(YYMMDD) 

8 60 CE 00350 Administered 

dosage form 

8 CWE Administered 

dosage form 

60 CE Administered 

dosage form 

13 (**) n2 + n6 Packaging date 

(YYMMDD) 

9 200 CE 00351 Administration 

notes 

9 CWE Administration 

notes 

200 CE Administration 

notes 

15 (**) n2 + n6 Best before date 

(YYMMDD) 

10 200 XCN 00352 Administering 

provider 

10 XCN Administering 

provider 

200 XCN Administering 

provider 

17 (**) n2 + n6 Expiration date 11 200 CM 00353 Administered-at 

location 

11 LA2 Administered-at 

location 

200 CM Administered-at 

(YYMMDD) location

20 n2 + n2 Variant number 12 20 ST 00354 Administered per 

(time unit) 

12 ST Administered 

per (time unit) 

20 ST Administered per 

(time unit) 

21 n2 + X..20 Serial number 13 20 NM 01134 Administered 

strength 

13 NM Administered 

strength 

20 NM Administered 

strength 

22 n2 + X..29 Secondary data 

fields 

14 60 CE 01135 Administered 

strength units 

14 CWE Administered 

strength units 

60 CE Administered 

strength units 

240 n3 + X..30 Additional Item 

Identification 

15 20 STb 01129 Substance lot 15 ST Substance lot 20 ST Substance lot 

number number number 

241 n3 + X..30 Customer part 

number 

16 26 TSc 01130 Substance 16 DTM Substance 26 TS Substance 

expiration date expiration date expiration date 

242 n2 + n...6 Made-to-order 

variation number 

17 60 CEd 01131 Substance 

manufacturer 

name 

17 CWE Substance 

manufacturer 

name 

60 CE Substance 

Manufacturer 

Name 

250 n3 + X..30 Secondary serial 

number 

18 200 CE 01136 Substance 

refusal reason 

18 CWE Substance/treat 

ment refusal 

reason 

200 CE Substance 

refusal reason 

251 n3 + X..30 Reference to 

source entity 

19 200 CE 01123 Indication 19 CWE Indication 200 CE Indication 

253 n3 + n13 + 

n..17 

Global Document 

Type Identifier 

(GDTI) 

20 2 ID 01223 Completion 

status 

20 ID Completion 

status 

2 ID Completion 

status 

254 n3 + X..20 GLN extension 

component 

21 2 ID 01224 Action code 21 ID Action code— 

RXA 

2 ID Action code 

30 n2 + n..8 Count of items 

(variable measure 

trade item) 

22 26 TS 01225 System entry 

date/time 

22 DTM System entry 

date/time 

26 TS System entry 

date/time 

23 5 NM 01696 Administered 

drug strength 

volume 

23 NM Administered 

drug strength 

volume 

5 NM Administered 

drug strength 

volume 

24 250 CWE 01697 Administered 

drug strength 

volume units 

24 CWE Administered 

drug strength 

volume units 

250 CWE Administered 

drug strength 

volume units 

25 60 CWE 01698 Administered 

barcode identifier 

***** 

25 CDW Administered 

barcode 

identifier * 

60 CWE Administered barcode identifier 

26 1 ID 01699 Pharmacy order 

type 

26 ID Pharmacy order 

type 

1 ID Pharmacy order 

type 

G-3 
— f

 

 

 

 

 

 

 

 

Impact of a Two-Dimensional Barcode 

Legend: GTIN = Similar data content 

Lot number = Similar data content 

Expiration date = Similar data content 

GS1 

HL7—RXA Message Segment 

HL7 Vaccine Administration Data CDC 2.5.1 Implementation Guide X12—837 P Transaction HITSP Immunization Message Component Pharmacy EDI

g (Pharmacy/Treatment Administration) 

27 180 PL 02264 Administer-at 27 PL Administer-at 

28 106 XAD 02265 Administered-at 

address 

28 XAD Administered-at 

address 

a See researcher notes f Data retrieved from health care claim professional 4010 and 5010 Data retrieved from HITSP Immunization Message g The pharmacy standard follows the National Drug 

b Any printable ASCII characters are allowed. 

c Time stamp data type 

versions. For further information about this standard see researcher 

notes. 

Component document Code 

(NDC) for the product administered 

d Coded element data type. 

e Definition: This field contains the pharmacy system’s 

assigned barcode number for the give occurrence. For IV 

orders, many pharmacy systems generate a barcode number 

to identify a specific bag/bottle of the order. This number can 

be an instance identifier—unique for the patient, drug 

combination, and schedule instance, or it may be just a drug 

identifier. 

The composition and use of the barcode number depend on 

application negotiation. An example of this field follows: The 

barcode number is in the following format: 9XXXXXXX000. 

The number 9 is a constant, XXXXXXX is seven (7) 

****characters for a unique identifier assigned or derived from 

the patient account and order ID, and 000 is the zero-filled 

three (3) character IV bottle number. 

The maximum length of the first component of this field is 40 

characters to allow for the maximum existing barcode length 

in use today. The second component contains the description 

of the item being coded and the third component may define 

the barcode type. 

Example: 12345678901^IV bottle^3X9 

G-4 
Appendix G — Data Mapping 

 

 

-

- 

- 

 

 

 

 

 

 

 

 

 

 

 

 

Table G-3. Data Mapping—Specific Data 

This table is a subset of the data in the data mapping table. Whereas the data mapping table includes information such as headers and footers, this table contains only 

the GTIN, expiration date, and lot number, and how those pieces of information would be mapped across standards. 

Data Mapping for Vax Barcodes 

Legend: GTIN = Similar data content 

Lot Number = Similar data content 

Expiration date = Similar data content 

GS1 HL7 VACCINE ADMINISTRATION DATA 

HL7 RXA message segment

(Pharmacy/Treatment Administration) CDC 2.5.1 Implementation Guide X12 837 P Transaction** HITSP Immunization Message Component Pharmacy EDI * 

Application 

Identifiers Format Data Content SEQ LEN DT ITEM # Data Content SEQ LEN DT Data Content DT LEN Data Content SEQ LEN DT Data Content Notes LEN DT Data Content Notes LEN DT Data Content Notes 

1 n2 + n14 Global Trade 

Item Number 

(GTIN) 

17 60 CE*** 01131 Substance 

manufacturer 

name 

5 CWE Administered 

code 

CE 60 Substance 

manufacturer 

name 

1 5 NM Labeler code The first five 

digits identify the 

manufacturer of 

the drug 

and are 

assigned by the 

Food and Drug 

Administration 

Substance 

manufacturer 

Follows HL7 4–5 NM Labeler code Follows NDC 

format 

5 100 CE 00347 Administered 

code 

17 CWE Substance 

manufacturer 

name 

CE 100 Administered 

code 

2 4 NM Product 

segment 

It identifies the 

strength, dosage 

form and 

formulation 

Administered 

code 

Follows HL7-This 

field identifies the 

medical substance 

administered. If the 

substance 

administered 

is a vaccine, CVX 

codes should be 

used in the first 

triplet to code this 

field (see HL7 Table 

0292 - Codes 

for vaccines 

administered). 

3–4 NM Product 

segment 

Follows NDC 

format 

23 5 NM 01696 Administered 

drug strength 

volume 

25 CDW Administered 

barcode 

identifier * 

NM 5 Administered drug 

strength volume 

3 2 NM Package 

segment 

It identifies 

package size 

1–2 NM Package 

segment 

Follows NDC 

format 

24 250 CWE 01697 Administered 

drug strength 

volume units 

15 ST Substance lot 

number 

CWE 250 Administered drug 

strength volume 

units 

10 n2 + X..20 Batch or lot 

number 

15 20 ST* 01129 Substance lot 

number 

16 DTM Substance 

expiration date 

ST 20 Substance lot 

number 

NM Substance lot 

number 

17 (**) n2 + n6 Expiration date 

(YYMMDD) 

16 26 TS** 01130 Substance 

expiration date 

TS 26 Substance 

expiration date 

Please note that the GTIN has the NDC embedded within it and the information in the NDC is what provides the information in the yellow-coded fields across standards 

G-5 
 

 

 

 

 

 

 

 

 

 

• labeler code is 4 or 5 digits long 

and assigned by the FDA upon 

submission of a Labeler Code 

Request 

• product segment is 3 or 4 digits 

long and identified a specific 

strength, dosage form, and 

formulation for a particular firm 

• package segment is 1 or 2 digits 

long and identifies package 

forms and sizes 

NDC-GTIN Transaction Contention Area 

The NDC is embedded in the GTIN. The NDC-coded product package begins with a 3 (UPCA) or 03 (EAN-13). The remainder of the digits are the 10 NDC digits, plus the check digit. 

This is the most minimal form of the NDC code with 10 digits only. Because the NDC code 

has been linked with product barcodes in this way, the NDC code could contain ambiguities 

in this form. For example, 1234-5678-90, 12345-678-90, and 12345-6789-0 could all be 

entirely different products with the same barcode 1234567890. 

Figure G-1. Data Mapping Elements for GTIN and NDC 

 

 

 

 

 

 

Impact of a Two-Dimensional Barcode 

Researcher Notes 

Figure G-1 includes a summary of the NDC-GTIN mapping issue, notes for HL7, and a 

pictorial view of how elements from the GTIN are mapped to the NDC. 

Notes for HL7 

Data Content: 

1. Administered Code (CWE) 00347 

Components: <Identifier (ST)> ^ <Text (ST)> ^ <Name of Coding System (ID)> ^ 

<Alternate Identifier (ST)> ^ <Alternate Text (ST)> ^ <Name of Alternate Coding System 

G-6 
Appendix G — Data Mapping 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(ID)> ^ <Coding System Version ID (ST)> ^ <Alternate Coding System Version ID (ST)> 

^ <Original Text (ST)> 

Definition: This field contains the identifier of the medical substance/treatment 

administered. It is equivalent to the OBR-4-universal service ID in function. If the substance 

administered is a vaccine, CVX codes may be used to code this field. 

2. Administered Drug Strength Volume (NM) 01696 

Description: This numeric field defines the volume measurement in which the drug strength
 

concentration is contained. For example, Acetaminophen 120 MG/5ML Elixir means that 120
 

MG of the drug is in a solution with a volume of 5 ML, which would be encoded in RXA-13,
 

RXA-14, RXA-23, and RXA-24 as:
 

RXA|||||||||||||120|mg^^ISO|||||||||5|ml^^ISO ...<cr>
 

4.14.7.24 RXA-24 

3. Administered Drug Strength Volume Units (CWE) 01697 

Components: <Identifier (ST)> ^ <Text (ST)> ^ <Name of Coding System (ID)> ^ 

<Alternate Identifier (ST)> ^ <Alternate Text (ST)> ^ <Name of Alternate Coding System 

(ID)> ^ <Coding System Version ID (ST)> ^ <Alternate Coding System Version ID (ST)> 

^ <Original Text (ST)> 

Description: This field indicates the volumetric unit associated with RXA-23 Administered 

Drug Strength Volume. 

HL7 RXA-25 Barcode Identifier 

Definition: This field contains the pharmacy system’s assigned barcode number for the 

give occurrence. For IV orders, many pharmacy systems generate a barcode number to 

identify a specific bag/bottle of the order. This number can be an instance identifier—unique 

for the patient, drug combination, and schedule instance, or it may be just a drug identifier. 

The composition and use of the barcode number depend on application negotiation. An 

example of this field follows: The barcode number is in the following format: 9XXXXXXX000. 

The number ‘9’ is a constant, XXXXXXX is seven (7) characters for a unique identifier 

assigned or derived from the patient account and order ID, and 000 is the zero-filled three 

(3) character IV bottle number. 

The maximum length of the first component of this field is 40 characters to allow for the 

maximum existing barcode length in use today. The second component contains the 

description of the item being coded and the third component may define the barcode type. 

Example: 12345678901^IV bottle^3X9 

G-7 
Impact of a Two-Dimensional Barcode 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The implementation guide should be updated to reflect the following: 

 Sending systems may use the RXA-25 (barcode) to hold the intact GTIN. 

 Receiving systems should store the GTIN. 

 Sending systems will use the GTIN and a mapping table to get the CVX and MVX and 

will get lot number and expiration date from the rest of the code. 

–	 Sending systems that know the GTIN will send the CVX, MVX, lot number, and 

expiration date. 

 Sending systems will send the CVX in RXA-5. 

 Sending systems may send the NDC in RXA-5 (in addition to the CVX). 

 Sending systems should send the MVX in RXA-17. 

 Sending system should send the lot number in RXA-15. 

 Sending systems should send the expiration date in the RXA-16. 

 Figure G-2 outlines the relationship between the GTIN, NDC, CVX, and MVX to 

demonstrate how mapping tables might work. 

Figure G-2. Diagram: Mapping GTIN to NDC, CVX, and MVX 

GTIN Bar Code Data 

Elements NDC Format Codes for Vaccine 

Administered (CVX code) 

Manufacturers of 

Vaccines (MVX) 

Data Elements: 

- 01=AI 

- 0= Indicator Digit 

- 03=GS1 Prefix 

- 12345=FDA Labeler Code 

- 678900=Product Package 

- 6=Check Digit 

Data Elements: 

-Labeler code 

-Product segment 

-Package segment 

Data Elements: 

- 2 to 3 digits long 

Data Elements: 

- 3 Alphabetical codes 

NDC Code List FDA Labeler 

Code 

FDA Product 

Code 

CVX Code MVX Code 

00006-4827-00 00006 4827 21 MSD 

As an example for the Varicella vaccine in the 

following diagram below, the NDC code list includes 

codes associated with the labeler and the product 

plus the CVX codes that indicate the product used in 

a vaccination and the MVX codes that indicate the 

manufacturer of a vaccine. 

= + 

G-8 
Appendix G — Data Mapping 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Health Care-GS1-128 

This table summarizes the application identifiers used in the GS1 standard. 

Application Identifier 

(AI) or Header Data Attributes 

Header Organization name, corporate logo and GLN number of the producer 

Header Product description (e.g., brand/quality/age ref/size/number in case/% 

ABV) 

(00) Mandatory Identification of a logistic unit—serial shipping container code (SSCC) 

(02) (Strongly Identification of a trade item (i.e., the case of bottles [GTIN]) 

Recommended) 

(37) (SR) Count of trade items contained in a logistic unit (i.e., number of cases on 

the pallet) 

(10) (SR) Batch/lot number 

(15) (SR) Minimum durability date (quality) (YYMMDD) (i.e., best before date if it 

appears on the label on the packaged goods) 

(17) Expiration date 

(21) Serial number 

Data attributes recommended for the health care GS1-128. 

Source: GS1. (2009, February). GS1 Standards Document, Business Process and System 

Requirements for Supply Chain Traceability, Global Traceability Standard for Healthcare. Retrieved 

from http://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Standard_Healthcare.pdf, p. 

56. 

X12 Formatting Example 

An EDI X12 Formatting Example 

The following is an example of an EDI document. EDI documents are typically sent in a 

format similar to the following code, except that the code shown has been broken into 

multiple lines for display, while the real document is a single long line of text. 

ISA* * * * *ZZ*SENDER *ZZ* 

RECEIVER *041201*1200*U*00305*000000101*1*P*^!GS 

*PO*SENDER*RECEIVER*041201*1200*101*X*003050!ST*850 

*000000101!BEG*22*NE*101**041201*123456!FOB*DF*ZZ*JM 

J!DTM*037*041205!DTM*038*041215!DTM*002*041218!TD1* 

CNT90*1!TD5****JJ*X!TD3*40!N1*OB**92*7759!N3*111 Buyer 

St!N4*Conyers*GA*30094*US!N1*SE*Foo Bar Sellers!N4****US 

!REF*DP*101!PO1*100*1*EA***ZZ*BL47*HD*100!PID*F**** 

Widget!PO4**1*EA!N1*CT**38*CN!N4****CN!CTT*1*100!SE*22 

*000000101!GE*1*101!IEA*1*000000101! 

G-9 
Impact of a Two-Dimensional Barcode 

Here is the same document “unwrapped” at the segment level and indented to show the
 

looping structure:
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ISA* * * * *ZZ*SENDER *ZZ*RECEIVER *041201*1200*U*00305*000000101*1*P*^!
 

GS*PO*SENDER*RECEIVER*041201*1200*101*X*003050!
 

ST*850*000000101!
 

BEG*22*NE*101**041201*123456!
 

FOB*DF*ZZ*JMJ!
 

DTM*037*041205!
 

DTM*038*041215!
 

DTM*002*041218!
 

TD1*CNT90*1!
 

TD5****JJ*X!
 

TD3*40!
 

N1*OB**92*7759!
 

N3*111 Buyer St!
 

N4*Conyers*GA*30094*US!
 

N1*SE*Foo Bar Sellers!
 

N4****US!
 

REF*DP*101!
 

PO1*100*1*EA***ZZ*BL47*HD*100!
 

EDI comes in a variety of standard definitions such as ANSI X12, EDIFACT, and TRADACOM. 

The example documents shown above are of the X12 variety. 

EDI documents are text files that are delimited into segments (in this example by the “!” 

character), and each segment is further delimited into elements (by the “*” character). 

Elements may also (rarely if ever) be subdivided into subelements (by the “^” character). 

In the “unwrapped” example above, each segment is on a line by itself. The first position in 

a segment is the segment identifier. For example, the first segment is an “ISA” segment 

and the last is an “IEA” segment. Each segment is made up of a number of elements. The 

first element in the “GS” segment is “PO.” (Note that segment identifiers are not considered 

elements.) 

The order and content of the segments create various levels of enveloping. The outermost 

level (from “ISA” to “IEA”) makes up the interchange. The next level (from “GS to “GE”) 

makes up the functional group. The last level (from “ST” to “SE”) contains the transaction 

set. Each interchange may contain multiple functional groups and each functional group 

may contain multiple transaction sets. The ISA, IEA, GS, GE, ST, and SE segments are all 

enveloping headers. Transaction sets are the data payloads in an EDI message. The 

example above is a purchase order. It is distinguished as a purchase order by the “PO” in 

the first element of the GS segment and the “850” in the first element in the ST segment. 

Looping occurs when a looping segment is encountered. Looping segments are not obvious 

by looking at the document itself. If the second example above were not provided, it would 

be impossible to determine correctly which segments were looping segments and which 

G-10 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Appendix G — Data Mapping 

were not. A looping structure ends when no more segments that belong in the loop are 

encountered. There is no explicit end to the looping mechanism. 

Example for Drugs 

Example 10—Drug Examples 

The examples in this section have been created with a mixture of uppercase and lowercase 

letters. This demonstrates that this is an acceptable representation. 

Drug Example 1—Drug Administered in the Physician’s Office 

Example of service in a physician’s office, which includes the billing for a drug administered 

in the office. 

Subscriber/patient Steve R. Vaughn 

Address 236 Diamond St., Las Vegas, NV 89109 

Sex M 

DOB 5/1/1943 

Subscriber identification # MBRID12345 

Group # GRP01020102 

Destination receiver XYZ Receiver 

ETIN 369852758 

Destination payer R&R Health Plan 

National plan identifier PLANID12345 

Billing provider/sender Associates in Medicine 

Address 1313 Las Vegas Blvd., Las Vegas, NV 89109 

TIN 587654321 

This table is an example of an X12 claim. Drugs are used here as an example because the 

NDC code is used, as it will be for vaccines. 

Contact person and phone number Bud Holly (801) 726-8899 

Pay-to provider Associates in Medicine 

Rendering provider Jim Hendrix 

National provider identifier 1122333341 

Taxonomy identifier 208D00000X 

Patient account number CLMNO12345 

Diagnosis 0359.1 

Case The service provided on 7/11/2004 is that the patient 

received an injection of immune globulin during an office 

visit. The service is billed with procedure code 90782. 

G-11 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Impact of a Two-Dimensional Barcode 

Coding for the drug is accomplished with an HCPCS procedure code of J1550 (injection, 

gammaglobulin, intramuscular, 10 cc). And the drug is also coded with an NDC of 00026-

0635-12 (BayGam® SDV, PF 10 ML). 

Place of service is an office. Total billed charges are $103.37. Sales tax is $3.37. 

This example demonstrates how drugs are billed along with services when provided by a 

physician’s office. Billing for the drug is found in segments #25 through 30. 

Abbreviations 

Abbreviation Definition HL7/X12 GS1 

SEQ Sequence: Order in which the field appears 

LEN Length devoted to the field 

DT Data type that is in the field 

SI Sequence ID (where field is in sequence) 

NM Numeric 

TS Point in time or time stamp 

CE Coded element 

XCN Extended composite ID number and name 

CM Composite 

ST String 

XAD Extended address 

ID Processing mode 

CWE Allows user to send a term from an arbitrary coding 

system 

CNE Primary code must be from a specified value set 

Format How field must appear (numbers, letters, characters) 

Item # Catalogue item in standard 

Application identifiers Identifier that is part of the GS1 general specification 

G-12 
 

 

 

 

 

 

 

 

 

 

Appendix G — Data Mapping 

Summary Table 

This is a summary mapping table as outlined in Chapter 6. 

HL7—Barcoding 2.5.1 HITSP 

HL7—Vaccine Message Implementation X12—837 P Immunization 

GS1 Administration Segment Guide Transaction Messages NCPDP 

Global 

Trade Item 

Number 

(GTIN) 

Substance 

manufacturer 

name 

Administered code Substance 

manufacturer 

name 

Labeler code Substance 

manufacturer 

Labeler 

code 

Administered 

code 

Substance 

manufacturer 

name 

Administered code Product 

segment 

Administered 

code 

Product 

segment 

Administered 

drug strength 

volume 

Administered 

barcode identifier 

Administered drug 

strength volume 

Package 

segment 

Package 

segment 

Administered 

drug strength 

volume units 

Administered drug 

strength volume 

units 

Expiration Substance Substance Substance 

date expiration date expiration date expiration date 

(YYMMDD) 

Batch or Substance lot Substance lot Substance lot Substance lot 

lot number number number number number 

Note: The GTIN has the NDC embedded within it and the information in the NDC is what provides the information 

in the yellow-coded fields across standards. 

G-13