(2) If components positive for HIV-1 Ag, anti-HIV-1/2, -HCV, or HBsAg are
transfused, patient follow-up must be long enough to determine whether infection has
(3) Licensed facilities must report errors and accidents that affect the safety,
quality, identity, purity, or potency of products.
1-8. QUALITY ASSURANCE AUDITS
a. Audits by the QA unit should be conducted periodically, according to a
predetermined schedule, to assess the effectiveness of QA system controls. QA audits
usually focus on systems.
b. Focused audits are used to address specific problem areas.
c. Results should be documented and submitted to the responsible head and
other management staff for review.
d. Self -Assessment Plan (SAP).
(1) List operations of blood establishment: divide and subdivide into systems,
critical control points (areas that affect the safety and quality of blood if not performed
correctly), and key elements (individual steps in each control point).
(2) Place relationships of different functions in an outline format or function
(3) The DA has a template available for all Army facilities that each site tailors
to its particular operation.
Return to Table of Contents