(3) A record must be maintained with inclusive dates of employment and
signatures and identifying initials or identification codes of personnel authorized to sign,
initial, or review reports and records.
o. Statistical or Summary Reports. QA programs use statistical records to
identify problems and trends. A yearly report (FDA requirement), prepared by the QA
unit, should use some type of statistical analysis to summarize the blood center's total
operation. The report should be prepared according to a formal plan that includes
information from and analysis of error and accident reports, adverse reaction reports,
fatalities, product returns or recalls, QC records, and PT results. The yearly report
should describe corrective and preventive actions already taken, with an analysis of
their effectiveness and proposals for additional actions that may be needed.
p. Record Retention. AABB Standards requires that it be possible to trace any
unit of blood or component from source to final disposition. Records must be organized
in a manner whereby donors are positively identified with each of their donations and
with every component prepared from each donation.
(1) Indefinite retention:
(a) Records of donors and donor blood.
1 Blood Donation Record (DD Form 572).
2 Information about units received from outside sources.
3 Identification of facilities that carry out any part of the manufacture of
4 Final disposition of each unit of blood or component.
5 Notification of permanent deferrals.
6 Records of prospective donors who have been indefinitely deferred
for the protection of the potential recipient or placed on surveillance.
7 Notification to transfusing facility of previous receipt of units from
donors subsequently found to be confirmed positive for HIV or HTLV or repeatedly
reactive for HIV-1 Ag.
(b) Records of patients
1 Difficulty in blood typing, clinically significant antibodies, and
adverse reactions to transfusion.