Quality Assurance

Quality Assurance monitors all aspects involved in the manufacturing of blood components to ensure the purity and potency of the product.

Blood Component Recalls A component of blood is recalled if the safety, purity or potency of the product or component may have been compromised.

Market Withdrawals The process of recalling components that were manufactured following all SOPs, but for which additional information, that violates a regulation, requirement or LifeSouth SOP, was obtained after labeling and distribution.

Lookback The quarantine (or discard) of previously donated units due to a current repeatedly reactive test result for HIV, HCV, HTLV, HBsAg and HBCore.

Recipient notification The notification of consignees about blood units whose donor has a confirmed test for a specific infectious disease. LifeSouth notifies consignees and instructs the consignee that recipient notification may be required.

Adverse Transfusion Related Events

All adverse transfusion-related events must be reported to LifeSouth as soon as possible by completing a Report of Adverse Transfusion Event form and include:

Suspected Anaphylactic Reactions can be due to various proteins present in the donor plasma.

Suspected Bacterial Contamination is most commonly associated with contamination during blood collection (skin or environmental bacteria) or during manipulation of products (e.g. preparation of platelet pools).

Suspected Graft-Versus Host-Disease is prevented by irradiating cellular blood components that will be transfused to patients who are blood relatives of the donor or to patients who are immunologically impaired.

Suspected Hemolytic Transfusion Reaction occurs when transfused red cells interact with a recipient’s antibodies. The most severe transfusion reactions result from transfusion of ABOincompatible red cells.

Suspected Post-Transfusion-Purpura may occur when the recipient has an alloantibody toward a platelet antigen and becomes exposed to that antigen.

Suspected Transfusion-related acute lung injury “TRALI” is characterized by cough, dyspnea, hypoxia, chills and fever, hypotension, noncardiogenic pulmonary edema.

Suspected Transfusion-Transmitted Disease: the following diseases can be transmitted by transfusion: Hepatitis C, Human T-cell lymphotropic virus type I and type II , Hepatitis B, HIV, Babesiosis, Chagas’ disease, Malaria, and West Nile Virus.