============================================================================= Run Date: SEP 02, 2020 Designation: PSO*7*612 Package : PSO - OUTPATIENT PHARMACY Priority: EMERGENCY Version : 7 SEQ #502 Status: Released Compliance Date: SEP 09, 2020 ============================================================================= Associated patches: (v)PSO*7*574 <<= must be installed BEFORE `PSO*7*612' Subject: CLOZAPINE OVERRIDE DEFECT FIXES Category: - Routine - Enhancement () Description: ============ The Health Integration & Modernization (HI&M) CLOZAPINE NCCC OVRD COVID-19 multi-build is an emergency patch to the National Clozapine Registry (NCR) software to correct defects to Clozapine National Clozapine Coordinating Center (NCCC) Override functionality. The NCR is maintained by the NCCC. The NCCC is responsible for VA's compliance with the clozapine Risk Evaluation and Mitigation Strategy (REMS), which is mandated by the Food and Drug Administration (FDA) for tracking clozapine patients. The multi-build contains the Mental Health patch YS*5.01*166 and the Outpatient Pharmacy patch PSO*7.0*612. The list of defects and their resolution is below. This patch is also being released with informational patch PSJ*5*403 that documents changes to Inpatient Medications' processing of clozapine overrides that are a result of the defect fixes in PSO*7.0*612 and YS*5.01*166. This patch addresses one enhancement to the Clozapine drug dispensing program: 1) Allows automatic update of the Clozapine Registration Number between Mental Health and Pharmacy Files. Additionally, this patch addresses these defects to the Clozapine drug dispensing program: 1) Resolves incorrect message displays when using the Inpatient and Outpatient Pharmacy Clozapine Manager's Options. 2) Resolves an issue where a National Override from NCCC was not honored after issuing a Local Temporary Registration Number or Local Special Condition Override. 3) Resolves an issue where the Clozapine Dispensing Frequency authorized by NCCC was not honored on patients after valid blood results. 4) Resolves an issue where a National Registration Number and Dispensing Frequency from NCCC was not honored after issuing a Local Temporary Registration Number. Defect Tracking System Ticket(s) & Overview: -------------------------------------------- Patch PSO*7.0*612 contains the following changes: 1. Requirement 1 Enhancement - Automate the Pharmacy Registration of NCCC Clozapine Authorizations. Problem: -------- Currently, national clozapine authorization numbers are sent by the National Clozapine Coordinating Center (NCCC) and filed into the CLOZAPINE PATIENT LIST file (#603.01). Later, a pharmacy user must manually execute Vista option Register Clozapine Patient [PSOL REGISTER PATIENT] (for new patients), or Edit Data for a Patient in the Clozapine Program PSOL [EDIT] (for previously registered patients). Resolution: ---------- Automate the clozapine registration process by automatically updating the patient's clozapine registration number and status when a new National Clozapine number is received from the NCCC. Technical Resolution: --------------------- New Pharmacy API PSOCLADD has been created that accepts Patient DFN and NCCC Clozapine Authorization number as input and files the number into the CLOZAPINE REGISTRATION NUMBER field (#53) in the PHARAMCY PATIENT file (#55), and updates the CLOZAPINE STATUS field (#54) to 'A' for Active. This API is executed when a new clozapine authorization is filed into the CLOZAPINE PATIENT LIST (#603.01) file via a mumps action cross reference. 2. Requirement 1 Defect 1 - Incorrect Messages Displayed in Clozapine Vista Options Problem: -------- When more than one clozapine authorization number exists for a patient, the "Register Clozapine Patient" option currently displays the incorrect message, "Patient,Name has not been authorized for Clozapine by the NCCC (National Clozapine Coordinating Center). This option is only available for known NCCC-registered patients." when more than one entry exists in file 603.01 for the patient. This message displays regardless of patient's Clozapine Status in file 55. When more than one clozapine authorization number exists for a patient, the "Edit Data for a Patient in the Clozapine Program" option currently displays the incorrect message, "Patient,Name has not been authorized for Clozapine by the NCCC in Dallas. Contact the NCCC in Dallas for authorization." The patient cannot be selected. Resolution: ----------- The code associated with the 'Register a Clozapine Patient' option and the "Edit Data for a Patient in the Clozapine Program" shall be modified to display correct information about the patient's Clozapine registration status regardless of the number of clozapine numbers on file for the patient. The "Register Clozapine Patient" option shall display "Patient,Name is already registered with number CL99999. Use the edit option to change registration data, or contact your supervisor" when more than one entry in file 603.01 for the patient. No other change in functionality to this option. The "Edit Data for a Patient in the Clozapine Program" option shall not display the incorrect message "Patient,Name has not been authorized for Clozapine by the NCCC in Dallas. Contact the NCCC in Dallas for authorization". The option will allow the selection of a patient with more than one entry in file 603.01. No other change in functionality to this option. Technical Resolution: --------------------- Correct routine PSOCLUTL's lookups by patient into the CLOZAPINE PATIENT LIST file (#603.01) from $$FIND1^DIC, which fails when there is more than one clozapine authorization number on file for a patient, to D FIND^DIC, which finds all clozapine authorization numbers. The defective lookup is used as an initial test to allow the patient to be selected for registration; existing code will still prevent the patient from being selected due to previous registration, but the correct message will now display regarding the patient's registration status. 3. Requirement 2 Defect 1 - Patient with Temp Registration and an NCCC Authorization and NCCC Override Date, but day supply limited to 4. INC9951972: COVID-19 VistA PSO defect - Clozapine National Override patient's prescription limited to 4 days. Problem: -------- A Patient initially receives a 4-day emergency authorization, and later an NCCC Authorization and an NCCC Override Date. While the NCCC Override Date is still active, the Day Supply (for Outpatient Pharmacy) or Order Duration (for Inpatient Medications) continues to be limited to 4 days. Inpatient Medications Order Duration is defined as the number of days between the order's Start Date/Time and Stop Date/Time. Resolution: ----------- If a NCCC Authorized National Override Date is in effect following an initial local override, the system shall process an active clozapine patient's clozapine prescription under national override processes allowing the patient to be provided with the approved quantity associated with their individual dispensing frequency from the DISPENSE FREQUENCY field (#2) in the CLOZAPINE PATIENT LIST file (#603.01). The approved quantity is determined by the order's Days Supply for Outpatient Pharmacy orders, and the Order Duration (days between Start Date/Time and Stop Date/Time) for Inpatient Medications orders. Technical Resolution: --------------------- A change was made in several routines to look in the PHARMACY PATIENT file (#55) for the patient's active clozapine authorization number before searching for the value in the patient's DISPENSE FREQUENCY field (#3) of the CLOZAPINE PATIENT LIST file (#603.01). This enables the clozapine processing logic to any temporary initial local authorization on file that have been replaced by a permanent NCCC authorization numbers. - To address backdoor entry of outpatient orders, routine DAYSEN^PSODIR1 was changed to find the patient's registered clozapine authorization number. - To address backdoor entry of inpatient orders, routine ^PSOCLO1 was changed to find the patient's registered clozapine authorization number. - To properly calculate days supply during the finishing of pending orders, routine CLOZ^PSOORFI2 was changed to find the patient's registered clozapine authorization number. - To properly calculate days supply during the back door editing of active orders, routine ACT^PSOORNE2 was changed to find the patient's registered clozapine authorization number. - To properly calculate default Days Supply in CPRS, change DSUP^PSOSIGDS was changed to find the patient's registered clozapine authorization number. This changed routine is used by the ORWDPS1 DFLTSPLY Remote Procedure Call (RPC) to calculate default Days Supply. 4. Requirement 2 Defect 2 - Patient with NCCC Authorization receives a Special Condition Fill, and later an NCCC Authorization and Override Date, but day supply limited to 4. INC9951972: COVID-19 VistA PSO defect - Clozapine National Override patient's prescription limited to 4 days Problem: -------- A patient with an initial NCCC Authorization receives a Special Condition override, followed by an NCCC override, is limited to a Day Supply (Outpatient Pharmacy orders) or an Order Duration (Inpatient Medications orders) limited to 4 for clozapine orders. The NCCC national clozapine override and the patient's regular clozapine dispense frequency are ignored. Resolution: ----------- A patient with an initial NCCC clozapine authorization receiving a Special Condition override, followed by an NCCC override, shall be processed under national override rules allowing the patient to be provided with the approved quantity associated with their individual dispensing frequency from the DISPENSE FREQUENCY field (#2) in the CLOZAPINE PATIENT LIST file (#603.01). The approved quantity is reflected in the order's Days Supply for Outpatient Pharmacy orders, and the Order Duration (days between Start Date/Time and Stop Date/Time) for Inpatient Medications orders. Technical Resolution: --------------------- To address backdoor entry of outpatient orders, routine DAYSEN^PSODIR1 was changed to find the patient's registered clozapine authorization number. To address backdoor entry of inpatient orders, routine ^PSOCLO1 was changed to find the patient's registered clozapine authorization number. 5. Requirement 2 Defect 3 - Local Special Condition Override followed by valid lab results limits orders to 4-day supply. Problem: -------- When a patient with an active NCCC clozapine registration and no current clozapine lab results receives a Local Special Condition override, followed by the entry of valid clozapine lab results, subsequent pharmacy orders continue to be limited to a 4-day supply. Resolution: ----------- When a patient with an active NCCC clozapine registration and no current clozapine lab results receives a Local Special Condition override, followed by the entry of valid clozapine lab results, the Local Special Condition override is no longer in effect and should be ignored for new orders. New pharmacy orders should be processed using the days supply associated with their individual dispense frequency. The patient's dispense frequency is reflected in the order's Days Supply for Outpatient Pharmacy orders, and the Order Duration (days between Start Date/Time and Stop Date/Time) for Inpatient Medications orders. Technical Resolution: --------------------- Routine ^PSOCLO1 was modified to KILL the ^XTMP globals associated with the patient's local override when an active NCCC clozapine registration and valid clozapine lab results exist. This prevents the obsolete Local Special Condition override from interfering with the patient's regular clozapine dispense frequency. 6. Requirement 2 Defect 4 - Emergency Temp Override followed by new NCCC authorization limits orders to 4-day supply. Problem: -------- When a patient with a discontinued clozapine registration and current valid lab results receives a Local Emergency Temp Override, followed by a new NCCC clozapine authorization number and registration, subsequent pharmacy orders continue to be limited to a 4-day supply. Resolution: ----------- When a patient with a discontinued clozapine registration and current valid lab results receives a Local Emergency Temp Override, followed by a new NCCC clozapine authorization number and registration, the Local Emergency Temp override is no longer in effect and should be ignored for new orders. New pharmacy orders should be processed using the days supply associated with the patient's dispense frequency. The patient's dispense frequency is reflected in the order's Days Supply for Outpatient Pharmacy orders, and the Order Duration (days between Start Date/Time and Stop Date/Time) for Inpatient Medications orders. Technical Resolution: --------------------- Modify routines PSOCLUTL and PSOCLADD to KILL the ^XTMP globals associated with the patient's local override at the time an NCCC clozapine authorization number is registered to the patient. This prevents an obsolete local override from interfering with order entry routines' calculation of the days supply based on the patient's regular clozapine dispense frequency. Patch Components ================ Files & Fields Associated: File Name (Number) Field Name (Number) New/Modified/Deleted ------------------ ---------------------- -------------------- N/A (See YS*5.01*166 Patch Description related for Files/Fields) Forms Associated: Form Name File # 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 New/Modified/Deleted ---------------------- -------------------- N/A Templates Associated: Template Name Type File Name (Number) New/Modified/Deleted ------------- ---- ------------------ -------------------- N/A * * * * * * * * * * * Test Sites: ---------- New Jersey Health Care System (561) VA Connecticut Health Care System (689) Boise VA Medication Center (531) Software and Documentation Retrieval Instructions: -------------------------------------------------- The software for this patch is being released as a host file. The host file PSO_YS_CLOZ_COVID.KID contains patches PSO*7.0*612 and YS*5.01*166 and is available on the VA VistA download server at https://download.vista.domain.ext/index.html/SOFTWARE/. Documentation describing the new functionality is included in this release. Documentation can be found on the VA Software Documentation Library at: https://www.domain.ext/vdl/. Documentation can also be obtained at https://download.vista.domain.ext/index.html/SOFTWARE. ------------------------------------------------------------------------- Title File Name ------------------------------------------------------------------------- Technical Manual/Security Guide pso_7_0_p612_tm.docx - Outpatient Pharmacy V.7.0 pso_7_0_p612_tm.pdf User Manual - Manager - Outpatient pso_7_0_p612_man_um.docx Pharmacy V.7.0 pso_7_0_p612_man_um.pdf Deployment Installation Back-Out pso_7_p612_ys_501_p166_dibr.docx and Rollback Guide - HI&M pso_7_p612_ys_501_p166_dibr.pdf Clozapine Overrides Release Notes - HI&M Clozapine pso_7_p612_ys_501_p166_rn.docx Overrides pso_7_p612_ys_501_p166_rn.pdf Patch Installation: Pre/Post Installation Overview: ------------------------------- There are no tasks to be performed before the installation of this multi-build. Note that the routines should be backed up to a PackMan message before installing the build. 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. It should not be installed when the YSCL DAILY TRANSMISION option is running. If unsure when that is check the OPTION SCHEDULING file (#19.2) using FileMan: Select VA FileMan Option: Inquire to File Entries Output from what File: OPTION SCHEDULING// (17 entries) Select OPTION SCHEDULING NAME: YSCL DAILY TRANSMISSION Another one: Standard Captioned Output? Yes// (Yes) Include COMPUTED fields:(N/Y/R/B): NO// - No record number (IEN), no Computed Fields NAME: YSCL DAILY TRANSMISSION QUEUED TO RUN AT WHAT TIME: OCT 05, 2019@01:30 RESCHEDULING FREQUENCY: 1D TASK ID: 2577736 Installation Instructions: -------------------------- 1. Place the KIDS multi-build file PSO_YS_CLOZ_COVID.KID into a local directory and use the KIDS option Load a Distribution option to load it into the transport global. 2. Choose the INSTALL/CHECK MESSAGE PackMan option. 3. From the Kernel Installation and Distribution System Menu, select the Installation Menu. From this menu, you may elect to use the following options. When prompted for the INSTALL NAME enter: PSO*7.0*612 a. Backup a Transport Global - This option will create a backup message of any routines exported with this patch. b. 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 components of this patch (routines, DDs, templates, etc.). c. Verify Checksums in Transport Global - This option allows you to ensure the integrity of the routines that are in the transport global. 4. From the Installation Menu, select the Install Package(s) option and choose the patch to install (PSO*7*612). 5. Accept the default when prompted 'Want KIDS to Rebuild Menu Trees Upon Completion of Install? NO//' 6. Accept the default when prompted 'Want KIDS to INHIBIT LOGONs during the install? NO//' 7. Accept the default when prompted 'Want to DISABLE Scheduled Options, Menu Options, and Protocols? NO//' 8. If prompted 'Delay Install (Minutes): (0 - 60): 0// enter 0 (zero). Backout /Rollback Strategy: --------------------------- Backout will be done only with the concurrence and participation of development team and appropriate VA site/region personnel. The decision to backout the software will be a joint decision between development team, VA site and regional personnel, and other appropriate VA personnel. Rollback applies to data only and is not applicable to this multi-build. Prior to installing the KIDS multi-build, the site/region should have saved a backup of the routines in a PackMan 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. The new "AC" mumps cross reference for the CLOZAPINE PATIENT LIST file (#603.01) must be manually deleted via FileMan prior to restoring the backed up routines. The steps to delete the cross reference: 1. Access VA FileMan option Cross-Reference A Field via the VA FileMan Utility Functions [DIUTILITY] menu. 2. At the prompt, "What type of cross-reference (Traditional or New)?" enter NEW. 3. At the prompt, "Modify What File:" enter 603.01. 4. The new "AC" cross reference should be selected by default. 5. At the prompt "Choose E (Edit)/D (Delete)/C (Create):" enter DELETE. 6. At the prompt "Are you sure you want to delete the index definition? NO// YES" Example deletion of new "AC" index if backout is required: VA FileMan 22.2 Select OPTION: UTILITY FUNCTIONS Select UTILITY OPTION: CROSS-REFERENCE A FIELD OR FILE What type of cross-reference (Traditional or New)? Traditional// NEW Modify what File: REMOTE PROCEDURE// 603.01 CLOZAPINE PATIENT LIST (74 entries) Current Indexes on file #603.01: 1589 'AC' index Choose E (Edit)/D (Delete)/C (Create): DELETE Which Index do you wish to delete? 1589// AC Are you sure you want to delete the index definition? NO// YES Index definition deleted. Validation of Backout Procedure ------------------------------- The backout Procedure can be verified by printing the first 2 lines of the PSO* and YS* routines contained in the HI&M CLOZAPINE NCCC OVRD COVID-19 multi- build using the option First Line Routine Print [XU FIRST LINE PRINT]. Once the old routines listed in the multi-build patch have been restored, the first two lines of the Routines will no longer contain the designation of patch 612 in the patch list section on line 2 of the routines. The backout of the new "AC" cross reference on the CLOZAPINE PATIENT LIST file (#603.01) can be verified by repeating the backout steps and verifying that there is no longer a selectable "AC" cross reference to delete. Routine Information: ==================== The second line of each of these routines now looks like: ;;7.0;OUTPATIENT PHARMACY;**[Patch List]**;DEC 1997;Build 29 The checksums below are new checksums, and can be checked with CHECK1^XTSUMBLD. Routine Name: PSOCLADD Before: n/a After: B17784992 **612** Routine Name: PSOCLO1 Before:B207810764 After:B203292395 **1,23,37,222,457,574,612** Routine Name: PSOCLUTL Before:B110091416 After:B131109888 **28,56,122,222,268,457,574,612** Routine Name: PSODIR1 Before:B110146447 After:B117243135 **23,46,78,102,121,131,146,166, 184,222,268,206,266,340,391, 444,446,505,543,457,574,612** Routine Name: PSOORFI2 Before: B95796288 After: B96811540 **7,15,23,27,46,130,146,177, 222,225,338,313,408,612** Routine Name: PSOORNE2 Before:B111459106 After:B114548629 **11,21,23,27,32,37,46,84,103, 117,131,146,156,210,148,222, 238,264,281,289,251,379,391, 313,282,427,454,446,467,612** Routine Name: PSOSIGDS Before: B46733813 After: B56885810 **46,222,391,282,444,612** Routine Name: PSOSIGMX Before: B9129541 After: B9872406 **46,78,108,131,222,206,444,612** Routine list of preceding patches: 408, 467, 574 ============================================================================= User Information: Entered By : Date Entered : MAY 05, 2020 Completed By: Date Completed: SEP 01, 2020 Released By : Date Released : SEP 02, 2020 ============================================================================= Packman Mail Message: ===================== No routines included