Files > BLOOD BANK VALIDATION

name
BLOOD BANK VALIDATION
number
66.2
location
^LAB(66.2,
description
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.
Fields
#NameLocationTypeDetailsIndexDescription
.01name(+)0;1FREE TEXTBName of option being validated.
.02menu name(+)0;2FREE TEXTCName of menu
.03menu abbreviation0;3FREE TEXTDAbbreviation of menu
.04functional area(+)0;4SET OF CODES1:DONOR
2:INVENTORY
3:PATIENT
4:INQUIRIES
5:REPORTS
6:SUPERVISOR
7:INQUIRIES/WARD
8:DONOR/REPORTS
Functional area
.05option description(+)0;5SET OF CODES1:DATA ENTRY
2:DATA EDITING
3:DATA ENTRY/REVIEW
4:EDIT TEMPLATE/SOFTWARE CONTROL
5:FILE SETUP/SOFTWARE CONTROL
6:FORM/LETTER CONTENT
7:FORM/REPORT GENERATION
8:PURGING DATA/FILE ENTRIES
9:DATA INQUIRY ONLY
Description of option
.06limited access(+)0;6SET OF CODES1:YES
0:NO
0:no
1:yes
Whether access will be limited or not
.07option in use0;7SET OF CODES1:YES
0:NO
1:yes
0:no
Whether the option is used by the facility or not.
1date/time validated1;0MULTIPLE66.21Multiple for date/time validated

Not Referenced