Australia Blood Bank Compliance Checklist (TGA)
This blood bank compliance checklist ensures adherence to the Therapeutic Goods Act 1989, TGA requirements for Blood and Blood Components, Australian and New Zealand Society of Blood Transfusion (ANZSBT) guidelines, and NPAAC standards. Covers all aspects of blood banking from collection to transfusion including cold chain management, testing, compatibility, and haemovigilance reporting.
- Industry: Healthcare
- Frequency: Monthly
- Estimated Time: 35-45 minutes
- Role: Blood Bank Manager / Transfusion Scientist
- Total Items: 27
- Compliance: TGA Blood Regulations, ANZSBT Guidelines, NPAAC Standards, AS 3864, NATA Accreditation
Blood Storage & Cold Chain
Blood product storage and cold chain management.
- Blood fridge temperature (2-6 degrees C) continuously monitored?
- Platelet agitator functional (20-24 degrees C)?
- Plasma freezer temperature (-25 degrees C or below) monitored?
- Temperature alarm systems functional and tested?
- Transport containers validated for cold chain?
Testing & Compatibility
Pre-transfusion testing and compatibility procedures.
- Patient identification procedures followed (3-point check)?
- ABO/Rh typing and antibody screening performed correctly?
- Crossmatch procedures per ANZSBT guidelines?
- Reagent quality control performed daily?
- Transfusion-transmissible infection testing compliant?
Traceability & Documentation
Blood product traceability from vein to vein.
- Full traceability maintained (donation to transfusion)?
- ISBT 128 labelling standards followed?
- Electronic issue/crossmatch validated (if used)?
- Product discard records maintained?
Haemovigilance & Adverse Events
Transfusion reaction monitoring and reporting.
- Transfusion reaction monitoring protocol in place?
- Adverse events reported per haemovigilance requirements?
- Lookback procedures documented and followed?
- Near-miss incidents reported and investigated?
Quality Management
Blood bank quality management system.
- SOPs current, reviewed, and accessible?
- Proficiency testing/EQA participation current?
- Staff competency assessments documented?
- Internal audits completed as scheduled?
Emergency & Massive Transfusion
Emergency blood supply and massive transfusion protocols.
- Emergency O-negative stock maintained?
- Massive Transfusion Protocol (MTP) documented and accessible?
- After-hours blood supply procedures in place?
- Communication protocols with clinical teams established?
- Additional observations and actions required
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Why Use This Australia Blood Bank Compliance Checklist (TGA)?
This australia blood bank compliance checklist (tga) helps healthcare teams maintain compliance and operational excellence. Designed for blood bank manager / transfusion scientist professionals, this checklist covers 27 critical inspection points across 6 sections. Recommended frequency: monthly.
Ensures compliance with TGA Blood Regulations, ANZSBT Guidelines, NPAAC Standards, AS 3864, NATA Accreditation. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Australia Blood Bank Compliance Checklist (TGA) cover?
This checklist covers 27 inspection items across 6 sections: Blood Storage & Cold Chain, Testing & Compatibility, Traceability & Documentation, Haemovigilance & Adverse Events, Quality Management, Emergency & Massive Transfusion. It is designed for healthcare operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly. Each completion takes approximately 35-45 minutes.
Who should use this Australia Blood Bank Compliance Checklist (TGA)?
This checklist is designed for Blood Bank Manager / Transfusion Scientist professionals in the healthcare industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.