f. Labeling. Prior to issue, each unit must be appropriately labeled. As a
minimum, each unit should include the proper name of the component; the kind and
amount of anticoagulant; the volume of the unit; the required storage temperature; the
name and address of the collecting facility; whether the donor is a volunteer,
autologous, or paid; the expiration date and the unique donor number; and required
statements indicating "this product may transmit infectious agents" and "properly identify
intended recipient." Depending on the component, various test results such as ABO,
Rh, and antibody screening are required.
g. Repeat Testing. The facility performing the compatibility test must confirm
the ABO group on donor cells, obtained from the integral segment, of all units of whole
blood or red blood cells and the Rh type (D and Du) of all Rho (D)-negative units of
whole blood or red blood cells. Discrepancies shall be reported to the collecting facility
and resolved before the unit is issued for transfusion. Repeating other tests is neither
required nor recommended.
h. Previous Records. A donor's previous record of ABO group and Rh type
shall not serve for identification of units of blood subsequently given by the same donor;
new determinations shall be made for each collection.
i. Retention of Blood Samples. Processing samples shall be stored at 1C to
6C for at least 7 days after transfusion. When the blood is discarded, the processing
sample need not be saved.
j. Laboratory Records. The actual results of each test observed must be
recorded immediately, and the final interpretation must be recorded upon completion of
testing. The record system must make it possible to trace any unit of blood or blood
component from source (donor or shipping facility) to final disposition (transfused,
shipped, discarded), and to recheck the laboratory records applying to the specific
product, and to investigate adverse reactions manifested by the recipient. All records
must be retained for at least 5 years and 6 months. Legal requirements for retention of
records vary in different states.
k. Maintenance Details. Details for maintenance and storage including daily
inspection, refrigeration temperatures, bacteriological procedures, are included in the
next section. Techniques for performing the required laboratory tests, labeling
requirements, and methods of component preparation are given in detail in the
appropriate lessons of this subcourse.
MD0845
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