============================================================================= Run Date: JAN 23, 2024 Designation: RA*5*206 Package : RA - RADIOLOGY/NUCLEAR MEDICINE Priority: Mandatory Version : 5 SEQ #188 Status: Released Compliance Date: FEB 26, 2024 ============================================================================= Associated patches: (v)RA*5*143 <<= must be installed BEFORE `RA*5*206' (v)RA*5*157 <<= must be installed BEFORE `RA*5*206' Subject: DIAGNOSTIC CODE UPDATES TO BI-RADS Category: - Routine - Data Dictionary Description: ============ This patch will correct the following issue: In accordance with the Food and Drug Administration (FDA) Mammography Quality Standards Act, the National Radiology Program Office (NRPO) has provided updates to the BI-RADS diagnostic codes. (G) "Post-Procedure Mammogram for Marker Placement." Reserved for a post-procedure mammogram used to confirm the deployment and position of a breast tissue marker. (v) In cases where no final assessment category can be assigned due to incomplete work-up, one of the following classification statements shall be assigned as an assessment and reasons why no final assessment can be made shall be stated by the interpreting physician. (A) "Incomplete: Need additional imaging evaluation." Reserved for examinations where additional imaging needs to be performed before an assessment category identified in paragraphs (c)(1)(iv)(A) through (G) of this section can be given; or (B) "Incomplete: Need prior mammograms for comparison." Reserved for examinations where comparison with prior mammograms should be performed before an assessment category identified in paragraphs (c)(1)(iv)(A) through (G) of this section can be given. If this assessment category is used, a follow-up report with an assessment category identified in paragraphs (c)(1)(iv)(A) through (E) of this section must be issued within 30 calendar days of the initial report whether or not comparison views can be obtained. The information in its entirety can be found in the Federal Register: Mammography Quality Standards Act. This patch is part of the FDA BIRAD CODE UPDATES 1.0 updates. Below is a list of the applications involved in this project along with their patch numbers: APPLICATION/VERSION PATCH --------------------------------------------------------------- RADIOLOGY/NUCLEAR MEDICINE v5.0 RA*5.0*206 WOMEN'S HEALTH v1.0 WV*1.0*32 CLINICAL REMINDERS v2.0 PXRM*2.0*85 All these patches are released via a Kernel Installation and Distribution System (KIDS) multi-build distribution as FDA BIRAD CODE UPDATES 1.0. Patch Components: ----------------- Files & Fields Associated: File Name (Number) Field Name (Number) New/Modified/Deleted ------------------ ------------------- -------------------- DIAGNOSTIC CODES (78.3) EXPRESSION (#6) marked for deletion DISPLAY TEXT (#100) New Forms Associated: Form Name File Number New/Modified/Deleted --------- ----------- -------------------- N/A Mail Groups Associated: Mail Group Name New/Modified/Deleted --------------- -------------------- N/A Options Associated: Option Name Type New/Modified/Deleted ----------- ---- -------------------- N/A Protocols Associated: Protocol Name New/Modified/Deleted ------------- -------------------- N/A Security Keys Associated: Security Key Name ----------------- N/A Templates Associated: Template Name Type File Name (Number) New/Modified/Deleted ------------- ---- ------------------ -------------------- N/A Remote Procedure Name New/Modified/Deleted --------------------- -------------------- N/A Parameter Definitions Associated: Parameter Name New/Modified/Deleted -------------- -------------------- N/A New Service Requests (NSRs): ---------------------------- N/A Patient Safety Issues (PSIs): ----------------------------- N/A Defect Tracking System Ticket(s) & Overview: N/A Problem: -------- The National Radiology Program Office has provided two new national standardized BI-RADS diagnostic codes. Resolution: ------------ This patch will update the DIAGNOSTIC CODES file (#78.3) for distribution to the sites. There are two new BI-RADS codes that will be added. The BI-RAD Category 0 will be split into two so that waiting on additional imaging and waiting on priors will be two distinct codes. This is a new FDA requirement and currently both are combined under the same 1100 BI-RAD 0. Additionally, a BI-RAD R will be added. In order to comply with FDA mandated display text, the EXPRESSION field (#6) which currently points to the LEXICON owned EXPRESSIONS file (#757.01) will be deprecated. A new DISPLAY TEXT (#100) field will be added to the DIAGNOSTIC CODES file (#78.3) and it contains the text previously housed with LEXICON. Routines used to display diagnostic codes are modified to pull the required BI-RADS text from the new field, if applicable. New BI-RADS codes: NUMBER: 1107 DIAGNOSTIC CODE: BI-RADS R DESCRIPTION: Post-Procedure Mammogram for Marker Placement PRINT ON ABNORMAL REPORT: YES GENERATE ABNORMAL ALERT?: NO NUMBER: 1110 DIAGNOSTIC CODE: BI-RADS CATEGORY 0 DESCRIPTION: Incomplete: Need prior mammograms for comparison PRINT ON ABNORMAL REPORT: YES GENERATE ABNORMAL ALERT?: YES DISPLAY TEXT: Incomplete: Need Prior Mammograms for Comparison Test Sites: ----------- Northport VAMC (Northport, NY) Robley Rex VAMC (Louisville, KY) SNOW Change Order #: -------------------- Northport VAMC - CHG0437914 Robley Rex VAMC - CHG0437911 Software and Documentation Retrieval Instructions: -------------------------------------------------- The software for this patch is being released using a host file. The host file is available at the following location: /srv/vista/patches/SOFTWARE/FDA_BI_RAD_UPDATES_1_0.KID Documentation describing the new functionality is not included in this release. Patch Installation: ------------------- Pre-Installation Instructions: This patch may be installed with users on the system although it is recommended that it be installed during non-peak hours to minimize potential disruption to users. This patch should take less than 5 minutes to install. There are no options that need to be disabled. Create a backup of the following global file before continuing: DIAGNOSTIC CODES #78.3 ^RA(78.3 When you are creating a backup of a subscripted global, you are saving a partial global (a file within a global). You should use the utility ^%GOGEN, and when prompted for a global, enter the open global reference as shown below. Note that you may need to use GOGEN^%ZSPECIAL if you don't have permissions to access ^%GOGEN directly. Enter To create a Backup copy of: ------ -------------------------- ^RA(78.3, DIAGNOSTIC CODES Installation Instructions: 1. Use the Load a Distribution option contained on the Kernel Installation and Distribution System Menu to load the Host file. When prompted to "Enter a Host File:" enter /srv/vista/patches/SOFTWARE/FDA_BI_RAD_UPDATES_1_0.KID 2. From the Kernel Installation and Distribution System Menu, select the Installation Menu. From this menu, A. Select the Verify Checksums in Transport Global option to confirm the integrity of the routines that are in the transport global. When prompted for the INSTALL NAME enter FDA BIRAD CODE UPDATES 1.0 B. Select the Backup a Transport Global option to create a backup message. You must use this option and specify what to backup; the entire Build or just Routines. The backup message can be used to restore the routines and components of the build to the pre-patch condition. When prompted for the following, enter "B" for Build. Select one of the following: B Build R Routines Enter response: Build C. You may also elect to use the following options: i. Print Transport Global - This option will allow you to view the components of the KIDS build. ii. Compare Transport Global to Current System - This option will allow you to view all changes that will be made when this patch is installed. It compares all of the components of this patch, such as routines, DDs, templates, etc. D. Select the Install Package(s) option and choose the patch to install. i. If prompted 'Want KIDS to Rebuild Menu Trees Upon Completion of Install? NO//', answer NO ii. When prompted 'Want KIDS to INHIBIT LOGONs during the install? NO//', answer NO. iii. When prompted 'Want to DISABLE Scheduled Options, Menu Options, and Protocols? NO//', answer NO. Post-Installation Instructions: Installers please alert the radiology ADPAC/PACS Managers that new BI-RADS codes are available. If the sites do mammography in-house, they will need to load the new codes into their reporting system(s). Back-out/Rollback Strategy: --------------------------- Back-out will be done only with the concurrence and participation of development team and appropriate VA site/region personnel. The decision to back-out or rollback software will be a joint decision between development team, VA site/region personnel and other appropriate VA personnel. A national help desk ticket should be logged before attempting any backout procedures. Prior to installing an updated KIDS package, the site/region should have saved a backup of the routines in a mail message using the Backup a Transport Global [XPD BACKUP] menu option (this is done at time of install). The message containing the backed up routines can be loaded with the "Xtract PackMan" function at the Message Action prompt. The Packman function "INSTALL/CHECK MESSAGE" is then used to install the backed up routines onto the VistA System. If the new backup build option was used, after Xtracting the patch message use the KIDS Installation menu and enter FDA BIRAD CODE UPDATES 1.0b at the INSTALL NAME prompt. Data modified by this patch will be rolled back by utilizing the backup of DIAGNOSTIC CODES (#78.3) file that was created before the patch was installed. Validation of Back-out Procedure: --------------------------------- The Back-out Procedure can be verified by checking the entries in the DIAGNOSTIC CODES file (#78.3) file and verifying the pre-patch data is restored. ---- Routine Information: ==================== The second line of each of these routines now looks like: ;;5.0;Radiology/Nuclear Medicine;**[Patch List]**;Mar 16, 1998;Build 8 The checksums below are new checksums, and can be checked with CHECK1^XTSUMBLD. Routine Name: RABIRAD Before: B7783867 After: B8080355 **97,206** Routine Name: RAIPS206 Before: n/a After: B5805222 **206** Routine Name: RAO7PC2 Before: B48657820 After: B50852655 **1,11,14,16,22,27,45,75,56, 95,97,143,206** Routine Name: RAPRINT1 Before: B30536433 After: B30440063 **34,97,47,157,206** Routine Name: RART Before: B24437904 After: B24720333 **2,5,15,18,43,82,56,97,206** Routine Name: RARTR1 Before: B53930536 After: B57532798 **8,18,56,97,206** Routine list of preceding patches: 143, 157 ============================================================================= User Information: Entered By : Date Entered : AUG 23, 2023 Completed By: Date Completed: JAN 19, 2024 Released By : Date Released : JAN 23, 2024 ============================================================================= Packman Mail Message: ===================== No routines included