1 Organization

2 Personnel

3 Equipment

3.1 General Policies

3.2 Equipment Qualification and Validation

3.3 Equipment Calibration and Maintenance

3.4 Blood Component and Blood Product Storage

3.5 Blood Component and Blood Product Handling Equipment

3.6 Laboratory Equipment for Serological Testing

3.7 Blood Component and Blood Product Processing/Administration

4 Supplier Qualification and Contracts

5 Process Control

5.1 Blood Components and Blood Products

5.2 Requests for Blood Components, Blood Products and Pretransfusion Testing

5.3 Serologic / Pretransfusion Testing

5.4 Selection of Blood Components and Blood Products for Transfusion

5.5 Modification of Blood Components and Blood Products

5.6 Transportation and Disposal of Blood Components and Blood Products

5.7 Issue of Blood Components and Blood Products

5.8 Transfusion and Administration of Blood Components and Blood Products

5.9 Neonatal Transfusion

5.10 Hospital-Based Blood Donations

5.11 Home Transfusion

6 Documents and Records

6.1 Documents

6.2 Records

7 Non-Conformance and Adverse Reaction Management

7.1 Non-Conformance

7.2 Adverse Reactions

8 Assessments

8.1 Audit Program

8.2 Proficiency Testing

8.3 Self Assessments