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Secondary Data Analysis of the Two-Dimensional (2D) Barcoding Vaccine Pilot Study

Durbin, Joe (2014)
Master's Thesis (96 pages)
Committee Chair / Thesis Adviser: Orenstein, Walter
Committee Members: Bednarczyk, Robert A ; Kennedy, Erin (Centers for Disease Control and Prevention);
Research Fields: Health Sciences, Public Health
Partnering Agencies: Emory University schools, faculty or affiliated programs ; CDC
Keywords: Secondary Data Analysis; Two Dimensional Barcode; 2D; Vaccination; Immunization; Electronic Medical Record; Immunization Information System; barcode scanner
Program: Rollins School of Public Health, Career Masters of Public Health (Prevention Science)
Permanent url: http://pid.emory.edu/ark:/25593/gtfts

Abstract

2D barcoding use for vaccination administration in the U.S. health delivery system has gained gradual recognition as a viable way to improve completeness and accuracy of immunization records. Recording vaccination data has been a requirement since the passage of the National Childhood Vaccine Injury Act of 1986. Historically, records have had sub-optimal results with only 60% of reported vaccinations in Immunization Information Systems (IIS) having complete lot numbers.

This thesis project performed a secondary data analysis on data from the CDC/Deloitte Consulting 2011-2012 Implementation Pilot for Two-Dimensional (2D) Vaccine Barcode Utilization. The pilot provided 2D scanners to 217 public, private, and pharmacy immunizers to evaluate the impact of 2D barcoding on electronic medical records (EMR) and IIS records.

This thesis project cleaned, standardized, and analyzed two separate de-identified datasets - EMR and IIS - with 1,346,837 and 1,687,366 vaccination records respectively. The results of the analysis of pre- versus post-implementation of 2D scanning in EMR data showed 1) increases in average completeness -- 4.2% in lot number data (93.3% versus 97.5%); 9.9% in expiration dates (86.0% versus 95.9%)-- and increases in average accuracy - 5.2% in lot numbers (91.0% versus 96.2%), and a 12.8% in expiration date (79.8% versus 92.5%); 2) the public practices had greater data quality than private sites (i.e., 3.2% and 6.4% greater completeness for lot number and expiration dates respectively; and 4.7% and 12.6% greater accuracy for lot number and expiration results respectively); and 3) the private practices had greater improvement of completeness and accuracy from pre- to post-implementation than the public sites indicating that private sites may have more room for improvement.

The impact of a fully integrated EMR with 2D barcoding if expanded out to the entire U.S. population could translate into millions of more complete and accurate vaccination records. For example of the 19.2 million vaccinated children < 6, there could be 2,457,600 more with accurate expiration dates. Patient safety could benefit from 2D barcoding by improving consistency with the Vaccine Adverse Event Reporting System (VAERS), reducing errors to free up more time for patient care, and contributing to greater accuracy in the event of vaccine safety recalls.

Table of Contents

List of Figures .................................................................................................................... iii

List of Tables ..................................................................................................................... iii

Chapter 1 - Introduction ...................................................................................................... 1

1.1. Introduction and rationale ........................................................................................ 1

Context........................................................................................................................ 1

Background .................................................................................................................. 2

Known relationships between barcoding and EMR usage .......................................... 4

Implementation Pilot for 2D Vaccine Barcode Utilization ......................................... 5

1.2. Problem statement .................................................................................................... 6

1.3. Theoretical Framework ............................................................................................ 7

Key Concepts of 2D Barcoding for Vaccinations. ...................................................... 7

1.4. Purpose statement ..................................................................................................... 9

1.5. Research questions ................................................................................................... 9

Question 1 - Use of 2D Technology ............................................................................ 9

Question 2 - Public versus Private Clinic Delivery Site ............................................ 10

1.6. Significance statement ............................................................................................ 10

1.7. Definition of terms ................................................................................................. 11

Chapter 2 - Review of Literature ...................................................................................... 13

2.1. Introduction ............................................................................................................ 13

2.2. Need for More Accurate and Complete Vaccine Records ..................................... 13

2.3. History of 2D Barcode Use with Vaccines ............................................................ 16

1997 Vaccine Identification Standards Initiative (VISI) ........................................... 16

2001 HIMSS Recommendation ................................................................................. 16

2003 FDA Requires Linear Barcodes ........................................................................ 17

FDA and AAP ........................................................................................................... 17

August 2011 - FDA Barcode Rule Change Allowing 2D Barcodes ......................... 18

October 2010 - CDC Feasibility Study: Impact of Transition to 2D Barcodes ......... 18

2D Vaccine Barcode Pilot Study ............................................................................... 19

2.4. Summary of current problem and study relevance ................................................. 20

Chapter 3 - Methodology ................................................................................................. 22

3.1. Introduction ............................................................................................................ 22

3.2. Population and sample ........................................................................................... 23

Total Pilot Sample ..................................................................................................... 23

Thesis Sample ............................................................................................................ 24

3.3. Procedures .............................................................................................................. 26

Pilot Study Procedures .............................................................................................. 26

Definition of Completeness and Accuracy ................................................................ 28

Reference Dataset ...................................................................................................... 31

3.4. Plans for data analysis ............................................................................................ 33

3.5. Limitations and delimitations ................................................................................. 34

Limitations ................................................................................................................. 34

Delimitations ............................................................................................................. 35

Chapter 4 - Results ........................................................................................................... 37

4.1. Introduction ............................................................................................................ 37

Description of Practices and Vaccinations. ............................................................... 37

4.2. Findings .................................................................................................................. 39

Use of 2D Technology. .............................................................................................. 39

Public versus Private Clinic Delivery Site. ............................................................... 43

4.3. Other findings ......................................................................................................... 46

Private Site Improvements Pre- and Post-Implementation........................................ 46

Pre- versus Post-Implementation Results. ................................................................. 47

4.4. Summary ................................................................................................................ 47

4.5. Data Tables ............................................................................................................. 48

Chapter 5 - Discussion ..................................................................................................... 66

5.1. Introduction ............................................................................................................ 66

5.2. Summary of study .................................................................................................. 66

5.3. Discussion and Implications ................................................................................... 68

Inconsistencies with IIS versus EMR Data. .............................................................. 68

Expanding 2D Barcode Utilization. ........................................................................... 69

Private Practices Vaccination Recording Procedures. ............................................... 70

Potential Impact. ........................................................................................................ 71

Improved Patient Safety ............................................................................................ 71

5.4. Recommendations .................................................................................................. 72

Additional Statistical Methods .................................................................................. 73

EMR Full Integration of 2D Barcoding. .................................................................... 75

5.3. Conclusion .............................................................................................................. 76

References ......................................................................................................................... 78

Appendix 1 - Full List of Vaccines in Pilot Data ............................................................. 81

Appendix 2 - Full List of Variables ................................................................................. 84

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