An Update on Two-Dimensional (2D) Vaccine Barcoding

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1 An Update on Two-Dimensional (2D) Vaccine Barcoding 2016 AIRA Annual Conference April 2016 Ken Gerlach, MPH Immunization Services Division, CDC Regina Cox Deloitte Consulting, LLP 1 Immunization Services Division National Center for Immunization & Respiratory Diseases

2 Session Outline Background and Overview 2D Adoption Findings Data Quality Time Savings User Experience Next Steps - 2 -

3 Background and Overview

4 CDC 2D Barcoded Vaccine Initiatives 2D Barcoded Vaccine Information What's in a 2D barcode on a vaccine? Vaccine two-dimensional (2D) barcodes contain more data than traditional, linear barcodes. Vaccine Barcode Contents by Type Linear NDC 2D NDC Lot Number Expiration Date 2D Barcodes provide a significant data capacity increase over linear barcodes 4

5 Number of 2D Barcoded Product Presentations in the Marketplace November 2015

6 CDC 2D Barcoded Vaccine Initiatives 2D Pilot (2D) - Assess Impact ( ) Objectives Assess 2D impact to vaccination data quality Assess 2D workflow impact Identify 2D scanning opportunities and challenges Implement 2D barcodes on Vaccine Information Statements (VIS) Participants 217 healthcare practices 10 Immunization Awardees 2 Vaccine manufacturers Data 8 months of vaccine administration data Workflow analysis Participant surveys 2D Adoption (2DA) - Facilitate Adoption ( ) Objectives Broaden observations of the initial pilot Facilitate the adoption of 2D barcode scanning Participants 87 Diverse practices 7 Immunization Awardees 3 Vaccine manufacturers Data 4-7 months of vaccine administration data Workflow analysis Participant surveys 6

7 Data Sources 2D Adoption (2DA) Project Record Level Data 1,424,877 Vaccination Records 18.1% of Vaccination Records - 2D Barcoded Scan Verification Ability Survey Data Leader Experience Survey: 67 individuals completed survey (67 sites : 82% response rate) User (Staff) Experience Survey: 116 individuals completed survey (63 sites : 55% response rate of individuals; 77% response rate of sites) Workflow Analysis (WFA) Participation 20 facilities visited during pilot (observation of work process, time measurements of data entry, and interviews with facility staff) - 7 -

8 2D Adoption (2DA) Findings: Data Quality Time Savings User Experience

9 2D Adoption Findings: Data Quality Record Level Data

10 Data Quality Evaluation Questions 1. To what extent does vaccine administration data quality change with the introduction of 2D barcode scanning? 2. How does data quality differ between vaccine administration records that were scanned and those that were not? 3. Is there variation among facilities in compliance with scanning 2D barcoded vaccines?

11 Data Highlights There are 944,205 vaccine administration records included in EMR files provided for the 2DA pilot Based on lot number, 363,105, or 38.5%, of records were 2D barcoded

12 Does data quality improve after the introduction of 2D barcode scanning? o o o Lot number total correctness improved by 8% after 2D scanner installation. Expiration date total correctness improved by 11% after 2D scanner installation. Both of these improvements are statistically significant 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Data Quality Pre- and Post 2D Scanner Installation 84% 92% Lot Number (n=926208) 73% 84% Expiration Date (739,247) Timeframe: pre and post install Pre-Scanner Installation Post-Scanner Installation Type of barcode: both 2D and linear

13 What is the total correctness of vaccine administration records that were scanned versus entered via traditional methods? o Lot number data quality was 95% among scanned vaccines and 94% among vaccines that were entered via traditional methods. o Expiration date total correctness was 96% among scanned vaccines and 85% among vaccines that were entered via traditional methods. 100% 95% 90% 85% 80% Data Quality of Vaccine Administration Data Scanned versus Entered via Traditional Methods 94% 95% 96% 85% o Both of these improvements were statistically significant. 75% Lot Number (n=126,202) Not Scanned Scanned Expiration Date (n=117,428) Timeframe: post install Type of barcode: both 2D and linear

14 How does data quality differ by compliance to 2D barcode scanning?. o o o Findings are not consistent with expectations. The highest data quality is among those facilities with low compliance to 2D scanning The worst expiration date data quality is among those sites with medium levels of compliance (10-30%) There are very slight differences among lot number data quality by level of compliance 100% 98% 96% 94% 92% 90% 88% 86% Data Quality by Compliance with 2D Barcode Scanning 97% 97% 97.6% 90.1% 99% 98% 84% High (30% or More) Medium (10-30%) Low (<10%) Lot number Total Correct Expiratino Date Total Correct

15 Recommendations for Data Quality exploration 1. Explore data quality in a single system removing differences in technology across sites 2. Consider introduction of controlled training and education approaches to increase compliance

16 2D Adoption Findings: Time Savings WFA/Surveys

17 Time Savings Evaluation Questions 1. Does the use of 2D barcodes to record data about vaccine administrations change the amount of time it takes to record vaccine information? 2. To what extent do perceptions of 2D barcode scanning efficiencies for recording data about vaccines administered align with observations?

18 Level of agreement/disagreement regarding 2D barcode scanning saving the respondent time with respect to recording vaccines administered (TR3 18a) Respondents (%) Strongly Disagree Disagree Neither Agree nor Disagree Agree Strongly Agree Leader (n= 42) User (n=88) Source: User and Leader Surveys

19 Measured time savings Scanning 2D barcodes was, on average, 3.44 seconds faster than recording data from vaccines without 2D barcodes using the traditional method. This difference was statistically significant at an alpha of 0.05 (t(1,024)=30.91, p=0.001) Data Entry Method N Avg Time to Record 2D Barcode Scanning Non-2D Barcode Scanning Manual Entry Manual Entry & Drop Down Menus Drop Down Menus Linear Scanning Source: Linked Workflow Analysis Data (time) and Survey data (method)

20 Recommendations to improve time savings 1. Fully integrate 2D barcode scanning with EMR systems 2. Increase the number of opportunities for scanning 2D barcoded vaccines by introducing 2D barcodes on all vaccine products 3. Take actions to improve scanning experience (both reliability/ consistency and ease of use)

21 2D Adoption Findings: User Experience - Surveys

22 User Experience Evaluation Questions 1. What is the experience of the end user during the process of adopting 2D barcodes to record vaccine information? 2. What is the potential for sustaining 2D barcode scanning after the current project?

23 Agreement with ease of integrating 2D barcode scanning into normal procedures for recording vaccines administered (TR3 12a) Respondents (%) Strongly Disagree Disagree Neither Agree nor Disagree Agree Strongly Agree Leader (n=42) User (n=88) Source: User and Leader Surveys

24 Agreement with preference of using 2D barcode scanning over any other approaches used previously to record vaccine data (TR3 17) User Respondents (%) Strongly Disagree Disagree Neither Agree nor Disagree Agree Strongly Agree Admin (n=88) Invent (n=33) Source: User Survey

25 User Identified Benefits, Challenges and Keys to Sustainability Over half of leaders noted that it was likely or extremely likely that their facility would continue using 2D barcode scanning after the project ended to record vaccines administered. Benefits Increased accuracy and completeness Reduced time to enter data Improvements in inventory Patient safety and alerting Keys to Sustainability Additional barcoded products Improved ease of use in scanning technology Challenges Inconsistent scanner response Full integration to EMR Not all vaccines have 2D barcodes Additional data field populated from a single scan Additional benefits (including EHR alerts) Improved inventory tracking

26 Next Steps

27 Next Steps Promote pilot educational materials Continue to monitor 2D Barcoded Vaccines in the supply chain beyond just three large manufacturers Continue to Maintain NDC Crosswalk Table as a resource for Health Information Systems (HIS) Monitor Drug Supply Chain Security Act (DSCSA) Encourage HIS vendors to incorporate 2D barcode functionality Explore opportunities to improve compliance Explore scalability of barcoding in single, health system

28 CDC 2D Barcoded Vaccine Initiatives Where to find more information Where can I find additional information? Visit the CDC 2D barcode page for 2D vaccine resources Google: CDC 2D Barcode What s on the site? Current list of 2D barcoded vaccines 2D Pilot artifacts For Providers Training materials AAP guidance For Developers NDC Crosswalk Tables with Global Trade Identification Numbers (GTIN) 2D Scanning functional capabilities requirements For Manufacturers Secondary packaging 2D report AAP and GS1 2D guidance 28

29 Thank You-Happy Scanning For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA Telephone, CDC-INFO ( )/TTY: Web: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. 29 National Center for Immunization and Respiratory Diseases Immunization Services Division

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