Improving Immunization Health Care Data Quality using Two-Dimensional Barcoding and Barcode Scanning Practices

Abstract

Background Manual data entry is time-consuming, inefficient, and error prone. In contrast, leveraging two-dimensional (2D) barcodes and barcode scanning tools is a rapid and effective practice for automatically entering vaccine data accurately and completely. CDC pilots documented clinical and public health impacts of 2D barcode scanning practices on data quality and completeness, time savings, workflow efficiencies, and staff experience.

Objectives Data entry practices and entered records from routine and mass vaccination settings were analyzed. Data quality improvement opportunities were identified.

Methods A sample of 50 million emergency use authorization (EUA) coronavirus disease 2019 (COVID-19) vaccine records were analyzed for accuracy and completeness across three data fields: lot number, expiration date, and National Drug Code (NDC). The EUA COVID-19 vaccines lacked a 2D barcode containing these data fields, which necessitated manual data entry at administration. A CDC pilot at clinic compared scanned and manually entered data for routine vaccines across these same data fields.

Results Analysis of 50 million manually entered EUA COVID-19 vaccine administration records indicated significant gaps in data accuracy and completeness across three data fields. Over half of the analyzed EUA vaccine NDCs (53%) and one-third of the expiration dates (35%) had missing or inaccurate data recorded. Pilot data also showed many errors when manually entered. However, when the pilot's routine vaccines were scanned (out of 71,969 records), nearly all entries were complete and accurate across all three data fields (ranging from 99.7% to 99.999% accurate).

Conclusion Vaccine 2D barcode scanning practices increased data accuracy and completeness (up to 99.999% accurate) across data fields assessed. When used consistently, vaccine 2D barcode scanning can resolve issues demonstrated in manually entered data. To realize these benefits, the immunization community should widely use scanning practices. To increase use, CDC developed a Vaccine 2D Barcode National Adoption Strategy and implementation resources.

 

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Keywords

public health - vaccines - data quality - immunization - vaccination - health records - population health - registries

Background and Significance

With approximately 130 million routine vaccine doses administered annually, even a small percentage of errors when recording vaccine administration data can amplify to a significant amount of inaccurate data in health information systems (HIS) (e.g., electronic health record [EHR] systems and immunization information systems [IIS]). Furthermore, manual vaccine data entry can be time consuming, tedious, and prone to human error.[1] [2] Capturing data accurately is essential for ensuring correct and complete vaccine records. The quality of data impacts vaccine recipient safety, such as by scanning to alert that an (in)correct vaccine is being administered, and thus records of vaccine administration, vaccine tracking and accountability, vaccine coverage assessments, and public health research.

Among the types of two-dimensional (2D) barcodes, GS1 Data Matrix 2D barcodes have the alphanumeric character capacity, omnidirectionality, and built-in error correction to encode the recommended vaccine data fields accurately and from any angle in the diminutive space of vaccine units-of-use (UoU), e.g., vaccine vials and syringes. Currently, GS1 2D barcodes are recommended on labels for vaccine units-of-sale (UoS), e.g., vaccine boxes, cartons/packaging, and are optional on UoU. As of early 2023, almost 90% of vaccine products on the market offer a 2D barcode on the vaccine UoU. Having a 2D barcode on UoU allows the vaccine provider to scan the unit to record the lot number, expiration date, and Global Trade Identification Number, in which National Drug Code (NDC) is embedded ([Fig. 1]).

Fig. 1 Vaccine 2D barcodes have a greater character capacity (GS1 Data Matrix = 2,335 characters) than linear, or 1D, barcodes (GS1–128 = 48 characters). This greater capacity enables 2D barcodes to encode the GTIN with embedded NDC, lot number, expiration date, and GS1 application identifiers. 1D, one-dimensional; 2D, two-dimensional; GTIN, Global Trade Identification Number; NDC, National Drug Code.

A growing body of evidence indicates that vaccine 2D barcode scanning improves data quality and completeness for lot number, expiration date, and NDCs, compared with manual entry, in pilots across a variety of clinical settings.[3] [4] [5] [6] Vaccine 2D barcode scanning practices, in coordination with vaccine 2D barcoded products, and HIS with 2D barcode scanning functionality have also been associated with improvements in data quality and vaccine recipient safety by confirming that the scanned vaccine is the correct vaccine being administered (and not one that is recalled based on the lot number; expired based on the expiration date; or contraindicated based on the NDC). These practices also reduced strain on staff, and improved efficiency in immunization settings, including the ability to increase the number of vaccinations providers are able to administer in the same period of time due to efficiency and time savings Vaccine 2D barcode scanning practices, in coordination with 2D barcoded vaccine products and HIS with 2D barcode scanning functionality, have been associated with improved data quality as well as improved vaccine recipient safety.[3] [7] Prior work details the methods, data collection, analysis, and findings from this pilot.[3] [4] [7]

Vaccine UoS and UoU recommendations for 2D barcodes are based on inventory purposes and interpretation of the Drug Supply Chain Security Act (DSCSA).[8] Vaccine packaging, i.e., UoS, is recommended to have a 2D barcode placed near the human-readable portion of the product identifier, in addition to and not in lieu of a linear barcode. If the vaccine manufacturer has identified the vaccine vial or prefilled syringe, i.e., UoU, as the smallest individual saleable unit to be sold to a vaccine administrator, then it is required to have a GS1 Data Matrix 2D barcode. As this is often not the case, and the smallest individual saleable unit is the UoS, a vaccine manufacturer may voluntarily add a GS1 Data Matrix 2D barcode on the UoU. Thus, although a GS1 Data Matrix 2D barcode is not required on the UoU, manufacturers voluntarily offer a 2D barcode on the UoU for approximately 90% of vaccine products in the field. Emergency use authorization (EUA) coronavirus disease 2019 (COVID-19) vaccines did have UoS 2D barcodes but did not have UoU 2D barcodes due to the nature of the emergency response and corresponding requirements in the DSCSA. Due to workflow and vaccine storage requirements for administration purposes, vaccine UoU vials, including EUA COVID-19 vaccines, were often separated from their UoS original packaging before the former was administered to vaccine recipients. Thus, vaccine 2D barcodes on UoU would be more useful and accessible.

 

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Objectives

Accurate vaccine records are paramount to tracking vaccinations, accountability (for IIS and EHR vaccine recipient records), vaccine coverage assessments, and public health research. Vaccine 2D barcode scanning practices modernize the supply chain's vaccine inventory processes, vaccine administration by providers, vaccine recipients' safety, and public health's data quality.

Widespread use of scanning practices is necessary to ensure accurate vaccine records. Through pilots and stakeholder engagement, Centers for Disease Control and Prevention (CDC) developed a Vaccine 2D Barcode National Adoption Strategy to increase use of vaccine 2D barcode scanning practices. The Strategy reflects and addresses the current needs of the immunization community and addresses key immunization partners, including manufacturers, HIS, and immunization providers.

 

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Methods

The COVID-19 emergency response offered an opportunity to analyze vaccination practices in an emergency response setting. During the COVID-19 mass vaccinations between January and June 2021, UoU barcodes were not available on EUA COVID-19 vaccines, which hindered the ability for scanning to document administration. In the summer of 2021, CDC conducted data quality and completeness analyses of a sample of COVID-19 vaccine records.

CDC analyzed a sample set of 50 million EUA COVID-19 vaccination records for lot numbers, expiration dates, and NDC data fields. This sample set was drawn from 5 weeks of vaccine administration records beginning in mid-January 2021. The 5 weeks were selected at a cadence of 1 week selected out of every 6 weeks. This sample selection ensured CDC was able to observe and analyze the quality of vaccine records across a period of 6 months.

Data for these sample weeks were provided by the CDC Immunization Data Lake, which had records from 63 of the 64 IIS. Jurisdictions included 49 U.S. states (Texas was unable to submit records due to legislative requirements), eight U.S. territories and freely associated states (Puerto Rico, U.S. Virgin Islands, American Samoa, Northern Mariana Islands, Guam, Marshall Islands, Palau, and the Federated States of Micronesia), and six local jurisdictions (Chicago, Illinois; Houston, Texas; San Antonio, Texas; Philadelphia, Pennsylvania; New York City, New York; and Washington, DC).

Data recorded into three data fields (lot numbers, expiration dates, and NDC) were separated from records and any identifiable information. Each data entry was extracted separately with its frequency count and the percentage of total frequency ([Table 1]). Due to the volume of records and the large number of possible “correct” values for each of the three fields, criteria were set to determine whether an entry could logically be accurate based on the format and characters expected for each field ([Table 2]). “Logical” criteria did not assess actual accuracy for that data field, only that the combination and length was feasible to be accurate. Fields with no data entered were categorized as “blank” in the analyses. Guidance for expiration date included an option to enter “2069” at some points; therefore, the decision was made to flag this specifically entered option separately. In practice, it would be considered “illogical” to have an expiration date so far in the future. However, given the emergency use context and in preparation for a time when data would permit more “logical” expiration dates to be encoded, it was possible this was an accurate entry. In reporting of results for the current article we included the 2069 entries as “logical.” Any data that did not fall within the range of “logical” were considered “illogical.”

Table 1 Examples of data entry analytics for EUA COVID-19 vaccine administration record analyses

Lot number	Frequency count	Percent of total frequency
008B21–2A	73501	0.366853267
008B212A	27617	0.13784012
LOT ER8730	17769	0.088687442
CLAREMONT 017B21	11918	0.059484323
1111–20-ER8737	10097	0.05039547

Table 2 “Logical” criteria for data entry fields for EUA COVID-19 vaccine administration record analyses

Field	“Logical” criteria
Lot number	Six to eight alphanumeric characters excluding dashes
Expiration date*	Less than nine numeric characters within the range of December 14, 2020 (date of first vaccine given) to the latest expiration date possible for the week's date range as found in CDC's Lot Number and Expiration Date Report file. *Expiration date of year 2069 were categorized separately from logical and illogical categories throughout the analysis
National Drug Code	Ten to 11 numeric characters excluding dashes

Separately, CDC pilot studies by the Vaccine 2D Barcodes Team evaluated implementation of vaccine 2D barcode scanning practices at multiple clinics within a health system, to determine the impact of scanning practices on data quality, workflows, staff experience, and overall vaccination practices. A recent CDC pilot[3] studying 27 provider sites within a health system compared data accuracy and completeness from vaccine records, which were manually entered against vaccine records completed through 2D barcode scanning. Across a six-month period, 71,969 vaccines (with a 2D barcode on the UoU) were administered across pilot sites (routine vaccines, prepandemic). Only vaccines with a 2D barcode on the UoU (and therefore only vaccines which could possibly be scanned) were included in analyses.

Inventory of pilot site vaccines provided a “reference file” of all possible lot numbers, expiration dates, and NDCs available for entry during the pilot period. Pilot data were analyzed against this reference file, to definitively assess accuracy of data records. In the pilot, the three data fields were considered “accurate” if vaccine records matched the reference file. If the field was populated but did not match the reference file, it was considered completed but inaccurate or “completed inaccurately.” Blank fields had no data entered. Further details on development of the reference file and other data accuracy methods are provided in a separate peer-reviewed article.[4]

 

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Results

Analysis of 50 million COVID-19 EUA vaccine administration records indicate data quality issues across all three data fields observed: lot number, expiration date, and NDC. More than half of the 50 million NDCs (53%) and one-third of the expiration dates (35%) analyzed had missing or inaccurate data recorded ([Fig. 2]). This represents 26.6 million NDC records and 17.7 million expiration dates recorded incorrectly. Within the expiration date field, 11% of the records analyzed included the CDC-recommended 2069 expiration date, which we counted as “logical” (and included within the 65% of records showing as logical in [Fig. 2]). Compared with the other data fields, lot number was more frequently accurate and complete, with 5% missing or “illogical”; however, that still suggested that over two million records in the analyzed sample were missing or inaccurate for this field.

Fig. 2 Data quality analyses for lot number, expiration date, and National Drug Code (NDC) data fields from EUA COVID-19 vaccine administration records during five sample weeks of the public health emergency. COVID-19, coronavirus disease 2019; EUA, emergency use authorization.

Data from a CDC pilot provided both manually entered and automatically scanned routine vaccine data in administration records during a 6-month period pre-COVID-19 pandemic.[3] Records of vaccines not scanned had missing data or inaccuracies between 5 and 10% across the same three data fields: lot number, expiration date, and NDC ([Fig. 3]). Expiration date had the highest amount of inaccurate data (6.6% of records inaccurate, with another 2.6% blank), with NDC missing more often than the other two fields (4.4% of records for this field were blank). Lot number entries were blank less often (0.2%) than the other two data fields but were still inaccurate for 4.7% of the records.

Fig. 3 Data quality analyses for lot number, expiration date, and National Drug Code (NDC) data fields from routine vaccine administration records during CDC pilot study when data are manually entered. CDC, Centers for Disease Control and Prevention.

At these same CDC pilot sites, during the same period of time, when 67,951 vaccines were scanned (out of 71,969 vaccines administered) nearly all entries were complete and accurate.[3] Accuracy for scanned vaccines across these three data fields were 99.999% (NDC), 99.97% (expiration date), and 99.68% (lot number). Implementation of vaccine 2D barcode scanning practices in a variety of clinical settings, including pediatrics offices, family practices, shot clinics, and internal medicine settings during this CDC pilot[3] resulted in improved data accuracy and completeness in vaccine records ([Fig. 4]).

Fig. 4 Data quality analyses for lot number, expiration date, and National Drug Code (NDC) data fields from routine vaccine administration records during CDC pilot study when data are automatically entered with vaccine 2D barcode scanning. 2D, two-dimensional; CDC, Centers for Disease Control and Prevention.

 

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Discussion

The findings in this work, particularly the gaps in accuracy and completeness[9] [10] [11] in manually entered vaccine records, emphasize the need for use of 2D barcoding on the UoU to improve health care provider efficiency and public health vaccine data monitoring and reporting accuracy. Leveraging 2D barcoding and barcode scanning tools and technologies for vaccine UoU can increase data accuracy and save time prior to, during, and after vaccine administration, but the immunization community must support scanning practices. Additional information about vaccine 2D barcode scanning pilots and findings is available at the CDC Vaccine 2D Barcodes Web site.[12]

A comparison of data quality was completed between the sample of manually entered vaccine data from COVID-19 EUA vaccine administrations and a recent CDC pilot with both manual and scanned vaccine data entries from routine vaccine administrations. While methods for determining accuracy between these two datasets differed slightly, these findings still merit comparison. CDC pilot data provided an exact understanding of accuracy, although requiring a robust level of effort to attain. The COVID-19 EUA analysis provides a slightly less exact result, but, if anything, it presents an overestimate of the accuracy of data as entries may have been logical without being accurate.

Data from CDC pilots[3] [4] and case studies, as well as the EUA COVID-19 data analysis findings, demonstrate that automated 2D barcode scanning of vaccine data can improve data quality issues present in manually entered vaccine data.

Scanning at administration can capture data quickly and accurately. Benefits of vaccine 2D barcode scanning includes high-quality data, time savings, improved staff experience, and the potential to save providers money through efficiencies.[13] Maximizing these benefits depends on widespread implementation and use of scanning.

Effective implementation of vaccine 2D barcode scanning requires an array of partners, including vaccine manufacturers, HIS, and providers and staff who give immunizations. CDC analyzed the immunization community landscape,[14] which confirmed the state of the field and fundamental requirements for widespread use of vaccine 2D barcode scanning practices to record vaccines. Identification of barriers across the immunization community established a CDC Vaccine 2D Barcodes National Adoption Strategy for widespread increase of, and adherence to, vaccine 2D barcode scanning practices. This National Adoption Strategy, along with outreach and assistance to partners in the immunization community, address gaps in vaccination settings to encourage and promote 2D barcode scanning.

There are five critical elements in the National Adoption Strategy, which are necessary for maximizing use of 2D barcode scanning ([Fig. 5]). These critical elements are: (1) all vaccines have 2D barcodes on the UoU and UoS, (2) all HIS vendors offer vaccine 2D barcode scanning functionality, (3) all providers have access to vaccine 2D barcode scanning components, (4) providers adopt and utilize vaccine 2D barcode scanning to record all vaccines, and (5) the immunization community is aware of, and promotes, vaccine 2D barcode scanning practices. These critical elements ensure that vaccines that can be scanned, are scanned, and that scanning practices are encouraged and promoted by key immunization partners. In addition to the overall critical elements across the immunization community, these elements are interlinked requirements, i.e., for providers to record vaccinations with 2D barcode scanning practices the vaccine requires 2D barcodes on the UoU and UoS, as well as a HIS that offers vaccine 2D scanning functionality, as well as those providers having access to vaccine 2D scanning components, and so on. Providers wanting to utilize 2D barcode scanning may consider which vaccine products have 2D barcodes on UoU, work with their HIS (EHR) or a third-party vendor to determine 2D barcode functionality, determine what additional hardware is needed for purchase and maintenance (e.g., scanners, computers), and plan for committing time and staff resources to establish an effective workflow and train staff, and to overcome technical barriers that arise.

Fig. 5 Five critical elements of the CDC Vaccine 2D Barcode National Adoption Strategy for widespread use of 2D barcode scanning to record vaccine inventorying and administration data. 2D, two-dimensional; CDC, Centers for Disease Control and Prevention; EHR, electronic health record; UoU, units-of-use.

CDC supports the use of vaccine 2D barcode scanning practices and vaccine 2D barcoding among the immunization community by increasing awareness of the technical requirements and benefits of implementing these practices, as well as the deficiencies when not implemented. The effort to ensure vaccine 2D barcodes are available on vaccine products and are used to record immunizations is ongoing. Barriers to implementing vaccine 2D barcode scanning exist in clinical settings, EHR systems, and vaccine manufacturing. As the Vaccine 2D Barcodes National Adoption Strategy is implemented, CDC aims to raise awareness of 2D barcode scanning benefits, increase provider adoption of, and adherence to, 2D barcode scanning practices, and improve data quality for routine and emergency response vaccine records.

Results from outreach to major vaccine manufacturers in December 2022 indicate vaccine manufacturers affix 2D barcodes on UoS and voluntarily add UoU 2D barcodes to 87% of the market's products for vaccine inventorying and administration. CDC engages vaccine manufacturers to track vaccine products and availability of 2D barcodes on UoU and encourages voluntary placement of the 2D barcode on UoU, which has the potential to transform mass vaccination processes by enabling UoU 2D barcode scanning at administration.

Data in a vaccine 2D barcode are automatically and accurately entered and error-checked by a HIS with 2D barcode scanning functionality. According to a landscape assessment in 2022, 80% of ambulatory health care providers use an HIS that offers vaccine scanning functionality. CDC engages HIS stakeholders directly and through partner organizations like the Electronic Health Record Association, American Immunization Registry Association, and the Healthcare Information and Management Systems Society. CDC offers several resources to assist HIS to add scanning functionality to their systems, including an annually updated functional capabilities guide to assist developers in adding the scanning functionality and a testing resource,[15] which provides HIS with examples of 2D barcodes to test their scanning functionality.

CDC pilot projects highlighted health care providers and their staff, including in pharmacies, as partners in adopting 2D barcode scanning practices for routine vaccine administration. Pharmacies often develop their own workflows and systems, which motivates their interest in 2D barcode scanning functionality and scanning practices. According to pharmacy outreach conducted in 2022, among chain pharmacies, 70% use or are interested in using 2D barcode scanning practices.

Resources in an Implementation Toolkit[16] were developed to assist stakeholders in overcoming barriers to implementation ([Fig. 6]). Additional resources are available on the CDC Web site,[12] including a 2D Barcode Functional Capabilities Guide[17] and tools for vaccine manufacturers, HIS vendors, providers, and the immunization community.

Fig. 6 2D barcode scannable links to tools and resources aligned to the five critical elements of the CDC Vaccine 2D Barcodes National Adoption Strategy. 2D, two-dimensional; CDC, Centers for Disease Control and Prevention.

Current work focuses on coordination with routine and emergency response vaccine manufacturers, EHR systems, and providers to understand and develop additional strategies to overcome barriers to implementation and optimization of vaccine 2D barcode scanning practices nationwide.

 

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Conclusion

As evident by the COVID-19 EUA vaccine administration data analyses work presented in this best practice paper, manual entry of vaccines produces gaps in data accuracy that can be addressed through use of vaccine 2D barcode scanning. The advantages of vaccine 2D barcode scanning practices in state-of-the-art immunization settings include significant increases[3] [4] in data accuracy, completeness, and time savings, as well as reduction in immunization data entry errors. Automated health data entry is a winnable battle, with the benefits of automated 2D barcode scanning realized with widespread use, and collaboration among stakeholders, such as clinicians and their staff, informaticians, EHR system vendors, and vaccine manufacturers.

Possible disadvantages for implementation of scanning practices may include the costs of technology (e.g., 2D barcode scanners) and availability of scanning functionality in the provider's EHR. Fortunately, the market prices for scanners have recently decreased, making them far more affordable. Availability of scanning functionality within many large EHR vendors has also increased in recent years, with scanning functionality often available at no extra cost to providers. Furthermore, these costs are often recouped in the return on investment in vaccine administration data quality.[18]

Widespread adoption and use of vaccine 2D barcode scanning practices depends on support from the immunization community. CDC continues to encourage use of vaccine 2D barcode scanning practices to record vaccines at administration and for inventory purposes and to encourage placement of 2D barcodes on vaccine UoS as well as UoU for all vaccine products. Resources developed by CDC include tools for providers considering implementation of 2D barcode scanning practices, resources that support HIS vendors developing and testing scanning functionality for vaccines, and a set of guidance and specifications resources for vaccine manufacturers.[12]

 

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Clinical Relevance Statement

Manual data entry can be time consuming, tedious, and prone to human error. Leveraging 2D barcoding and barcode scanning tools for vaccine UoU and UoS can increase data accuracy and save time for vaccine administrations, but the immunization community must support scanning practices for maximum benefit. The CDC Vaccine 2D Barcode National Adoption Strategy reflects the existing state-of-the-art of automated data entry practices and addresses critical elements across the immunization community. This work demonstrates the need for, and benefits of, using relevant automated 2D barcode scanning practices to improve vaccine administration data quality.

 

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Multiple-Choice Questions

1. Which components should be available for vaccine 2D barcode scanning to be used to record vaccine data?

   • A 2D barcode on the vaccine UoU or UoS

   • A scanning device and computer

   • Scanning functionality in the HIS

   • Staff trained in scanning practices

   • All of the above

   Correct Answer: The correct answer is option e. All of the above. This work discussed all four components above being available for vaccine 2D barcode scanning to be used to record vaccine data.

2. Which of the following is not a potential benefit of 2D barcode scanning for providers?

   • Saves time for inventory and administration

   • Accurately captures vaccine data

   • Reduces strain on vaccine administrators

   • Automatically reports data to the Vaccine for Children (VFC) Program

   • Allows providers to use automated data entry instead of manually entering lengthy data strings

   Correct Answer: The correct answer is option d. Automatically reports data to VFC. This work identified the other options above except for d.

3. Which of the following is not one of the five critical elements of the CDC Vaccine 2D Barcodes National Adoption Strategy?

   • All vaccines have 2D barcodes on the UoU and UoS

   • All HIS vendors offer vaccine 2D barcode scanning functionality

   • All providers have access to vaccine manual data entry practices

   • Immunization community is aware of, and promotes, vaccine 2D barcode scanning practices

   • Providers utilize vaccine 2D barcode scanning to record all vaccines

   Correct Answer: The correct answer is option c. All providers have access to vaccine manual data entry practices. This work indicated that a critical element of the CDC Vaccine 2D Barcodes National Adoption Strategy is that all providers have access to vaccine 2D barcode scanning practices.

 

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Conflict of Interest

None declared.

Acknowledgments

We gratefully acknowledge the CDC Immunization Services Division's Informatics and Data Analytics Branch members, such as Lynn Gibbs-Scharf and Stuart Myerburg, for helpful discussions, other CDC Vaccine 2D Barcodes Team members Kate Beagle, Tori Bonisese, and Christina Zapata for their design and analysis support, and the CDC Novel Coronavirus (COVID-19) Public Health Emergency Response Team Data Monitoring and Reporting Section members Lauren Shaw, Bhavini Patel Murthy, Elizabeth Zell, and Ryan Saelee for COVID-19 vaccine administration data sharing from the CDC Immunization Data Lake.

Protection of Human and Animal Subjects

Not applicable.

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Publication History

Received: 15 July 2023

Accepted: 25 January 2024

Accepted Manuscript online:
29 January 2024

Article published online:
03 April 2024