Emory IRB QA/QI

Topics

• QA/QI Mission
• Defining "Findings"
• Process
• Next Steps
• Questions

QA/QI Mission

• To identify improvement areas for the IRB staff and IRB office.
• To find educational needs, and areas that require policy changes.
• To find mistakes that need correction. Not developed for performance evaluations.

Defining "Findings"

• Finding: information or a fact that is discovered by reviewing something. For our QA/QI: anything Team Q finds when reviewing our records.
• Are all findings important?
• What is the purpose to record unimportant findings? For trends indicating needs for policy/edu changes

Defining "Findings"

• Are all findings important?
• Important (Major findings): findings that need to be fixed right away as the posed a risk for quality/ethics research.
• Examples: Letter or ICF indicates research is approved more than 1 year; staff disregard study that needed IRB review; CR sent expedited when needs FB review; no HIPAA doc stamped; old ICF stamped.

Process

• Findings identified and sent to TLs
• TLs review monthly; develop CAPA (if needed) and F/U with analyst
• Trends in minor and major findings, if any, are noted as year progresses
• Tracking sheet reviewed at end of year for “big picture” and tool for performance evals

Next Steps

• Continue with QA/QI plan
• TLs will communicate findings to staff during bi-weekly's
• Policies/Edu changes being made as a result of findings.

Questions?