LESSON 1
QUALITY PROGRAM AND INFORMATION MANAGEMENT
1-1. QUALITY ASSURANCE
Quality is the primary goal of blood centers and transfusion services. To ensure
the quality of the blood products we transfuse, all critical steps in each of the
procedures performed are described in standing operating procedures (SOPs). Current
quality standards require a more comprehensive, prospective, system-based model
than a description of each discrete activity. This new model is quality assurance (QA).
a. Whole blood and blood components are regulated both as drugs and biologics
by the FDA.
b. Current good manufacturing practice regulations (cGMP) are FDA
requirements for the drug industry, which includes the "manufacture" of blood. GMPs
are not just FDA recommendations; they are legal requirements (see definition in
glossary). Blood and blood products not manufactured according to cGMPs are
considered to be adulterated.
c. The Clinical Laboratory Improvement Act (CLIA) or DOD's Clinical Laboratory
Improvement Program (CLIP) specify additional regulations for laboratories to include
blood banks and donor centers.
d. Each facility should develop a QA program, which includes a written plan that
takes into account federal, state, and local regulations and professional standards and
should include the systems and measures that will be used to ensure meeting these
requirements and standards.
1-2. QA UNIT
a. The QA unit reports to senior management, e.g., the responsible officer.
b. The QA unit has the authority to stop a procedure or process that is not in
compliance with a facility's procedures, manufacturer's instructions, or regulations; and
to prevent the release of blood and blood components that violate regulations or that
may be considered unsafe.
c. The QA unit may approve release of blood/ blood products that do not meet
specifications, provided a documented review has been performed to establish that
products are safe for transfusion.
MD0868
1-2
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