STANDARD DATA DICTIONARY #66.2 -- BLOOD BANK VALIDATION FILE 3/24/25 PAGE 1
STORED IN ^LAB(66.2, (146 ENTRIES) SITE: WWW.BMIRWIN.COM UCI: VISTA,VISTA (VERSION 5.2)
DATA NAME GLOBAL DATA
ELEMENT TITLE LOCATION TYPE
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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.
IDENTIFIED BY: MENU NAME (#.02)[R]
CROSS
REFERENCED BY: NAME(B), MENU NAME(C), MENU ABBREVIATION(D)
66.2,.01 NAME 0;1 FREE TEXT (Required)
INPUT TRANSFORM: K:$L(X)>30!($L(X)<3)!'(X'?1P.E) X
LAST EDITED: SEP 21, 1993
HELP-PROMPT: Answer must be 3-30 characters in length. Enter name of option being validated.
DESCRIPTION:
Name of option being validated.
CROSS-REFERENCE: 66.2^B
1)= S ^LAB(66.2,"B",$E(X,1,30),DA)=""
2)= K ^LAB(66.2,"B",$E(X,1,30),DA)
66.2,.02 MENU NAME 0;2 FREE TEXT (Required)
INPUT TRANSFORM: K:X[""""!($A(X)=45) X I $D(X) K:$L(X)>50!($L(X)<2) X
LAST EDITED: SEP 21, 1993
HELP-PROMPT: Answer must be 2-50 characters in length. Enter menu text of option being validated.
DESCRIPTION:
Name of menu
CROSS-REFERENCE: 66.2^C
1)= S ^LAB(66.2,"C",$E(X,1,30),DA)=""
2)= K ^LAB(66.2,"C",$E(X,1,30),DA)
66.2,.03 MENU ABBREVIATION 0;3 FREE TEXT
INPUT TRANSFORM: K:X[""""!($A(X)=45) X I $D(X) K:$L(X)>3!($L(X)<2) X
LAST EDITED: SEP 23, 1993
HELP-PROMPT: Answer must be 2-3 characters in length.
DESCRIPTION:
Abbreviation of menu
CROSS-REFERENCE: 66.2^D
1)= S ^LAB(66.2,"D",$E(X,1,30),DA)=""
2)= K ^LAB(66.2,"D",$E(X,1,30),DA)
To allow look up/access to option based on the abbreviation.
66.2,.04 FUNCTIONAL AREA 0;4 SET (Required)
'1' FOR DONOR;
'2' FOR INVENTORY;
'3' FOR PATIENT;
'4' FOR INQUIRIES;
'5' FOR REPORTS;
'6' FOR SUPERVISOR;
'7' FOR INQUIRIES/WARD;
'8' FOR DONOR/REPORTS;
LAST EDITED: SEP 23, 1993
HELP-PROMPT: Enter the Blood Bank menu in which the option appears.
DESCRIPTION:
Functional area
66.2,.05 OPTION DESCRIPTION 0;5 SET (Required)
'1' FOR DATA ENTRY;
'2' FOR DATA EDITING;
'3' FOR DATA ENTRY/REVIEW;
'4' FOR EDIT TEMPLATE/SOFTWARE CONTROL;
'5' FOR FILE SETUP/SOFTWARE CONTROL;
'6' FOR FORM/LETTER CONTENT;
'7' FOR FORM/REPORT GENERATION;
'8' FOR PURGING DATA/FILE ENTRIES;
'9' FOR DATA INQUIRY ONLY;
LAST EDITED: SEP 23, 1993
HELP-PROMPT: Enter option description in terms of functionality.
DESCRIPTION:
Description of option
UNEDITABLE
66.2,.06 LIMITED ACCESS 0;6 SET (Required)
'1' FOR YES;
'0' FOR NO;
'0' FOR no;
'1' FOR yes;
LAST EDITED: SEP 23, 1993
HELP-PROMPT: Does option require additional security access in addition to the LRLAB, LRVERIFY and the
LRBLOODBANK keys, i.e. the LRBLSUPER or the LRLIASON?
DESCRIPTION:
Whether access will be limited or not
66.2,.07 OPTION IN USE 0;7 SET
'1' FOR YES;
'0' FOR NO;
'1' FOR yes;
'0' FOR no;
LAST EDITED: SEP 23, 1993
HELP-PROMPT: Is option in use at the facility? For example, if a site does not draw any type of donors,
including therapeutic phlebotomy and autologous donation, the donor menu options would be set to
NO.
DESCRIPTION:
Whether the option is used by the facility or not.
66.2,1 DATE/TIME VALIDATED 1;0 DATE Multiple #66.21
DESCRIPTION:
Multiple for date/time validated
66.21,.01 DATE/TIME VALIDATED 0;1 DATE (Multiply asked)
INPUT TRANSFORM: S %DT="ETX" D ^%DT S X=Y K:Y<1 X S:$D(X) DINUM=9999999-X
LAST EDITED: SEP 21, 1993
HELP-PROMPT: An option may have multiple validation dates even for the same version, depending on the outcome
of the validation.
NOTES: XXXX--CAN'T BE ALTERED EXCEPT BY PROGRAMMER
CROSS-REFERENCE: 66.21^B
1)= S ^LAB(66.2,DA(1),1,"B",$E(X,1,30),DA)=""
2)= K ^LAB(66.2,DA(1),1,"B",$E(X,1,30),DA)
66.21,.02 REASON FOR VALIDATION 0;2 SET (Required)
'1' FOR NEW VERSION;
'2' FOR PATCH;
'3' FOR RETROSPECTIVE;
'4' FOR LOCAL MODIFICATION;
LAST EDITED: SEP 21, 1993
HELP-PROMPT: In accordance with M-2, Part VI, Chapter 5, validation testing must be performed at these
specific times.
66.21,.03 VERSION NUMBER 0;3 FREE TEXT (Required)
INPUT TRANSFORM: K:$L(X)>10!($L(X)<2) X
LAST EDITED: SEP 21, 1993
HELP-PROMPT: Answer must be 2-10 characters in length.
66.21,.04 PATCH NUMBER 0;4 FREE TEXT
INPUT TRANSFORM: K:$L(X)>12!($L(X)<1) X
LAST EDITED: SEP 21, 1993
HELP-PROMPT: Answer must be 1-12 characters in length.
66.21,.05 PERSON PERFORMING VALIDATION 1;0 POINTER Multiple #66.22
66.22,.01 PERSON PERFORMING VALIDATION 0;1 POINTER TO NEW PERSON FILE (#200) (Multiply asked)
INPUT TRANSFORM: S:$D(X) DINUM=X
LAST EDITED: SEP 21, 1993
HELP-PROMPT: Who performed the validation, i.e. tested the options as per the prescribed test conditions?
NOTES: XXXX--CAN'T BE ALTERED EXCEPT BY PROGRAMMER
66.21,.06 OUTCOME 0;5 SET (Required)
'1' FOR ACCEPTABLE;
'2' FOR ACCEPTABLE WITH CORRECTIVE ACTION;
'3' FOR NOT ACCEPTABLE;
LAST EDITED: SEP 21, 1993
66.21,.07 APPROVED BY 0;7 POINTER TO NEW PERSON FILE (#200)
LAST EDITED: SEP 21, 1993
HELP-PROMPT: Name of person who reviewed the actual test results AND the record of errors/deviations from
the BB User Manual and approved implementation.
66.21,.08 DATE APPROVED 0;8 DATE
INPUT TRANSFORM: S %DT="ETX" D ^%DT S X=Y K:Y<1 X
LAST EDITED: SEP 21, 1993
66.21,.09 DATE IMPLEMENTED 0;9 DATE
INPUT TRANSFORM: S %DT="ETX" D ^%DT S X=Y K:Y<1 X
LAST EDITED: SEP 21, 1993
66.21,1 COMMENT 2;0 WORD-PROCESSING #66.211
LAST EDITED: SEP 21, 1993
HELP-PROMPT: Enter any comments/required corrective action applicable to the validation or the
determination of the acceptability.
FILES POINTED TO FIELDS
NEW PERSON (#200) DATE/TIME VALIDATED:APPROVED BY (#.07)
PERSON PERFORMING VALIDATION:PERSON PERFORMING VALIDATION (#.01)
INPUT TEMPLATE(S):
PRINT TEMPLATE(S):
SORT TEMPLATE(S):
LRBLVAL OCT 12, 1993@11:13 USER #0
SORT BY: ]@NAME// (User is asked range)
FORM(S)/BLOCK(S):