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| Day 1 | |||||
| Document Review | |||||
| Quality Assurance Documents | |||||
| 1. | Quality Assurance Plan | ||||
| 2. | Quality Assurance Reports and follow-up mechanisms | ||||
| 3. | Tracking/monitoring logs | ||||
| 4. | Consumer complaints | ||||
| 5. | Customer satisfaction | ||||
| 6. | Self-audits | ||||
| 7. | Error identification and follow-up process | ||||
| Policies and procedures related to: | |||||
| 1. | Confidentiality | ||||
| - Release of information | |||||
| 2. | IT security | ||||
| 3. | Drug storage and tracking logs | ||||
| 4. | Drug disposal | ||||
| 5. | Drug recall and return | ||||
| 6. | Chain of custody | ||||
| 7. | Training and staff education | ||||
| 8. | Maintenance and destruction of records and logs | ||||
| 9. | Shipping and handling | ||||
| 10. | Facility security | ||||
| Information Technology interview | |||||
| Tour | |||||
| 1. | Staff interviews and observation | ||||
| Day 2 | |||||
| Human Resource File Review | |||||
| Files are reviewed for evidence of: | |||||
| 1. | Licensure/registration | ||||
| 2. | Training/education | ||||
| 3. | Confidentiality statements | ||||
| 4. | Performance review | ||||
| Facility Tour | |||||
| Inspection of Facility: | |||||
| 1. | Drug storage | ||||
| 2. | Drug access | ||||
| 3. | Pharmacist interview | ||||
| 4. | Log/tracking documents review | ||||
| 5. | Staff interviews | ||||
| 6. | Organization of processes | ||||
| 7. | Labeling review process | ||||
| 8. | Handling of cytotoxic agents | ||||
| 9. | Handling of control substances | ||||
| 10. | Drug disposal | ||||
| 11. | Drug spill process | ||||
| 12. | Drug tracking process for recall/disposal/return | ||||
| 13. | Cleanliness and organization | ||||
| 14. | Packaging and shipping process | ||||
| 15. | Facility security | ||||
| 16. | Shipping/loading dock | ||||
| Exit Conference | |||||
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