Provides mechanism for documenting the mandated validation of the Blood Bank software options. Data entry in the file is NOT intended to replace the mandated documentation of the validation testing, including: (1) observations from testing, e.g. screen prints, logging files, printed reports, written transcriptions, data tapes, data disks, etc., (2) a record/log of unusual occurrences, bugs, deviations from the BB User Manual & resoltuion, or (3) final approval by other responsible individuals, including the BB Medical Director and the LIM. It MAY be used to replace the documentation of the review, the acceptability/ outcome of the review, the date/signature of approval and the date of implementation. This file offers longitudinal tracking of validation of the software to include the release of new versions, the installation of patches and the installation of any local modifications. The content and the formatting of the file is consistent with the worksheets provided in the Blood Bank User Manual and the Technical Manual and complies with the requirements of the the American Association of Blood Bank and the Food and Drug Administration. EDITING OF FILE IS NOT ALLOWED.
HELP-PROMPT: Does option require additional security access in addition to the LRLAB, LRVERIFY and the LRBLOODBANK keys, i.e. the LRBLSUPER or the LRLIASON?
HELP-PROMPT: Is option in use at the facility? For example, if a site does not draw any type of donors, including therapeutic phlebotomy and autologous donation, the donor menu options would be set to NO.
DESCRIPTION:
Whether the option is used by the facility or not.