# Presentation: 100430

## QA/QI IN PRACTICE

- VA Day at PRIM&R
- October 28, 2004
- J. Patrick Johnson, Ph.D.
- AO/R&D
- VA Loma Linda Healthcare System

## Reasons for QA/QI

- Assess strengths and weaknesses of HRPP
- Monitors compliance and drifts from standard practice
- May decrease likelihood of problems when 3rd party / external audits occur
- Accreditation standards require monitoring of HRPP (NCQA v2.1 INR 5)

## NCQA v2.1 INR 5

## NCQA v2.1 INR 5

## Reasons for QA/QI

- Ultimately, the main reason for QA / QI:
- Protect our research subjects who are real people
- Our veterans, patients, fathers, mothers, brothers, and sisters.
- How do we want them to be treated?

## QA/QI in Context

## Internal Monitoring of Research Projects with Human Subjects for Regulatory Compliance and Quality Improvement

- Mechanism for auditing
- Procedures for monitoring based on:
- Degree of External Oversight
- Risk Category
- PI Experience

## Degree of External Oversight

- 3 points – Local projects without external oversight
- 1 point – Proposals with external oversight (e.g., multicenter, coop, industry sponsored, etc.)

## Risk Category

- 1 point – Minimal Risk
- 3 points – Moderate Risk
- 5 point – High Risk

## PI Experience

- 3 points – No previously approved project involving human subjects
- 1 point – All others

## Assignment of Priority and Intervals for Monitoring

- with a score of 3
- Will not be subject to a formal schedule of monitoring
- Will be subject to random selection for monitoring to ensure compliance

## Assignment of Priority and Intervals for Monitoring

- with a score of 4 – 6
- Will be audited at regular intervals not to exceed two years

## Assignment of Priority and Intervals for Monitoring

- with a score of greater than 6
- Will be audited at least one a year
- Exact schedule will be determined by the IRB

## Additional Protocol Audits:

- Consent
- Obtaining consent prior to research
- IRB-approved consent
- Signatures, dates, etc.
- Documenting consent in the record
- Providing copy to S or auth. rep.

## Additional Protocol Audits:

- Compliance with IRB
- IRB/R&D approval prior to research-related activities (e.g., advertising, recruiting, screening, consenting, etc.)
- Using IRB-approved materials
- IRB/R&D approval prior to changes in protocol or consent

## Additional Protocol Audits:

- Compliance with IRB (Cont’d)
- Reporting unanticipated problems involving risks to human subjects (AE, SAE, safety reports (e.g., IND, IDE, MedWatch, or DSMB, as appropriate)
- Protocol Deviations (e.g., inclusion, exclusion, age, #Ss, sex, category of subject

## Additional Protocol Audits:

- Compliance with IRB (Cont’d)
- File in ORA complete and consistent with PI files & with applicable regulations
- Use of IND drugs (receipt, storage, security, dispensing, disposition) consistent with VA and FDA regulations
- Similar with IDEs

## Additional RCO Audits

- “For Cause” initiated by the IRB/R&D or ORA Administrative Staff
- Other

## Tools

- _[Audit Tool](file:///D:/AuditTool%20-%20REALLY%20final%20%20cprs.pdf)_

## Audit Report (Example 1)

## Audit Report (Example 2)

## Audit Report (Example 3)

## QA / QI & Audits for HRPP

- Document
- Document
- Document
- . . .

## What if...

- Discover Serious non-compliance?
- Assistance
- Local Office of Research Administration (ORA)
- VISN Help (Network Research Officer)
- Policy guidance (e.g, “What to Report”)
- Call to ORD, ORO, FDA, others