Session M10 Worksheets

1
Session M-10 Worksheets

• VA RCOs
• What we do and how we do it
• October 15, 2007

2
HRPP

• COMPONENTS
• IRB(s) RD
• IO PIs / Researchers
• ISO PO
• Bio-safety Pharmacy
• Affiliate Teams Coordinators
• Credentialing (RN PSB)
• Human Resources (HRMS, NPC, Affiliate)
• Voluntary Radiation Safety

• QA STRATEGIES
• Monitors Reports
• Sporadic Not-for-Cause Audits
• Secondary Review of Incident Reports
• Enrollment Data
• CPRS Progress Notes

• COMMUNICATE
• IRMS Staff
• E-mail / Phone / Take a Walk
• Drop-In Consult
• Mentor / Teach
• Observe Consent / Study Visit
• Talk with Subjects
• Town Hall Meeting

• TOOLS
• Attend Trainings / Grand Rounds / MM
• Walk the Halls
• Open-Door Policy
• Reasonableness Approach
• Humor
• Newsletter
• IATA Training / Monitoring

3
IACUC

• COMPONENTS
• Veterinarian IO RD
• Animal Facility Manager Caretakers
• Community Representative AO
• Animal Subcommittee IACUC Chair
• Union Member Biosafety
• RN / Occupational Health Rad Safety
• Infectious Disease Pharmacy
• Researchers / Staff EMS
• Engineering

• QA STRATEGIES
• Audit For and Not-for Cause
• Semi-annual report
• Walk through
• Support from Caretakers
• Chart Reviews
• Self Assessments

• COMMUNICATE
• E-mail / Phone / Take a Walk
• Memos
• IACUC Administration
• Face-to-Face
• Sharepoint Software
• Town Hall Meeting
• Group / Flash e-mail
• JIT Needs

• TOOLS
• Consult with Colleagues
• Walk Through
• Security Check
• Disaster Drills
• Emergency Plan test it
• Newsletter
• IATA Training / Monitoring

4
Research Safety

• COMPONENTS
• Subcommittee Research Safety
• Radiation Safety AO
• Chemical Safety Industrial Hygienist
• Bio-safety Officer Recombinant DNA
• Infection Control Safety Officer
• Facility Safety Union Representative
• GEMS Engineering EMS
• Pharmacist
• Police Vulnerability Assessment quarterly

• QA STRATEGIES
• Walk Around
• Audits
• Self-Assessments
• Minutes
• Complaints
• Annual Review
• Audit-logs
• Review of SRS/Continuing Review

• COMMUNICATE
• E-mail / Phone / Take a Walk
• Memos
• Face-to-Face
• Sharepoint Software
• Town Hall Meeting
• Group / Flash e-mail
• JIT Needs

• TOOLS
• IATA Training Education
• Cross-Fertilization MSDS
• Controlled substances Disaster Drills
• Bi-annual review of chemicals
• Veterinarian QA Outside Reviewers
• Vulnerability Assessment
• Hoods/Autoclave Certs
• Logs Eyewash, freezers, showers

5
IT Security

• COMPONENTS
• ISO PO/HIPAA IRMS
• CIO IT Procurement (VA, NPC, Univ)
• RD and all Subcommittees
• ACOS/R AO RCO VISN
• PIs Users ADP-Coordinator
• Contracts/AMMS Policy/Security
• Colleagues/Collaborators
• Sponsors Monitors

• QA STRATEGIES
• Inspections laptops / flash drives
• FISMA / FIPS 140-2 compliant
• Encryption
• Contract Review

• COMMUNICATE
• E-mail / Phone / Take a Walk
• Door-to-Door
• Sharepoint Software
• Town Hall Meeting
• Group / Flash e-mail
• Remind everyone that a hacker attempt is detected
  every millisecond!

• TOOLS
• PI Data Certification
• Re-evaluation at Continuing Review