FDA Blood Bank Inspection Checklist
FDA Blood Bank Inspection Checklist
General Items
- Review the blood bank's overall compliance history.
- Conduct interviews with staff regarding procedures.
- Assess general cleanliness and organization of the facility.
- Check for adequate inventory management systems.
Facility Compliance
- Ensure facility is licensed and registered with FDA.
- Verify compliance with state and local regulations.
- Check for proper signage indicating blood bank operations.
- Inspect for proper storage conditions for blood products.
Quality Control Procedures
- Review quality control (QC) policies and procedures.
- Confirm regular calibration of equipment.
- Ensure appropriate temperature monitoring for storage units.
- Check for documented QC records for blood products.
Donor Screening and Processing
- Verify donor eligibility screening procedures.
- Check documentation of donor medical history.
- Ensure proper informed consent procedures are in place.
- Inspect blood collection and processing methods for compliance.
Labeling and Record Keeping
- Ensure blood products are labeled correctly per FDA regulations.
- Review records of blood donations and transfusions.
- Check for accurate tracking of blood products from donation to distribution.
- Verify retention of records for the required period.
Staff Training and Competency
- Review staff training programs and records.
- Confirm competency assessments for blood bank personnel.
- Check for ongoing education opportunities for staff.
- Ensure staff understands emergency procedures.
Incident Management and Reporting
- Review procedures for adverse event reporting.
- Ensure documentation of incidents and corrective actions taken.
- Check for regular audits of incident management processes.
- Verify compliance with FDA reporting timelines for serious events.
Generated from Panda Checklist
Get More Done with Checklist App
Stop juggling multiple tools and spreadsheets. Our app helps you organize tasks, collaborate with your team, and track progress all in one place.
Smart Task Management
Create and organize tasks with priorities, due dates, and reminders.
Team Collaboration
Share checklists, assign tasks, and track progress in real-time.
Progress Tracking
Visualize progress with charts and stay motivated with achievements.