f. Proficiency Testing (PT). PT, such as a CAP survey, is a means for
determining that test methods and equipment are working as expected and that staff are
(1) Under CLIA or CLIP, ABO and Rh must be appropriately identified 100% of
(2) PT requirements must be described in a written program and must be
performed by all staff who perform the procedure, using both routine and back-up
(3) QA unit review and monitors PT results, periodically evaluates the PT
program, and approves corrective action plans taken when PT results are unacceptable.
g. Documentation. SOPs document critical steps performed in the manufacture
and transfusion of blood and blood components. Processing records provide evidence
that requirements have been met and that any deviations have been appropriately
h. Record Systems. A written protocol for managing records is necessary to
ensure that the required records are generated, reviewed for completeness and
accuracy, approved, maintained in usable condition, retained for specified time periods,
and organized for traceability and retrievability.
i. Confidentiality. Blood bank records must not be released or made available
to unauthorized persons. Restricted access to computerized records must be ensured
by an appropriately maintained computer access security system.
j. Record Design. Each form should have a title that explains its intended use
and should include the name of the facility and address to distinguish it from other
institutions. Including as much preprinted information as possible minimizes the number
of manual entries needed.
k. Media. Records may be kept on paper, either printed or indelibly handwritten,
or they may be retained entirely electronically, provided they can be easily retrieved for
reference or review and adequate backup exists in case of system failure.
l. Corrections. If it is necessary to alter or correct any record, the reason for
change should be noted and the date and the person responsible for the change must
be identified. Do NOT use white-out or obliterate original. Draw one line through the
error, correct, and initial. Personnel must also be able to correct or add information to
records stored on each type of medium in use (microfilm, computer tape, etc.).
Computer records should permit tracking of both original and corrected data to include
the date and user ID of the person making the change.