$TXT Created by MORTON,RANDY at MHCVSS.FO-ALBANY.MED.VA.GOV (KIDS) on Tuesday, 09/05/06 at 14:27 ============================================================================= Run Date: SEP 14, 2006 Designation: YS*5.01*90 Package : YS - MENTAL HEALTH Priority: Mandatory Version : 5.01 SEQ #75 Status: Released Compliance Date: OCT 15, 2006 ============================================================================= Associated patches: (v)YS*5.01*74 <<= must be installed BEFORE `YS*5.01*90' Subject: CLOZAPINE UPDATES Category: - Routine - Data Dictionary - Enhancement (Mandatory) - Other Description: ============ Recent changes in the Clozapine protocol require changes to the Clozapine Roll Up software. Originally, all Clozapine prescriptions were limited to 7 days. Renewals and refills were not allowed. In addition, the Clozapine reporting software automatically discontinued any patient if the patient's prescription was over 28 days old. This was to prevent a patient from being issued medication on an expired prescription. The revised Clozapine protocol allows for a monthly prescription as well as weekly and bi-weekly. The patient is now automatically discontinued if the issue date for the most recent prescription is greater than 56 days in the past. The weekly roll-up creates a report that is sent to the local G.PSOCLOZ mail group. This report lists the patients reported to the national database along with an indicator showing whether or not Lab and RX data were transmitted. This report has been updated to show the date of the most recent WBC (White Blood Count) and Neutrophil Count along with the date of the most recent Clozapine prescription. Mental Health and Pharmacy personnel responsible for prescribing and dispensing Clozapine should be made aware of this mail group and given the opportunity to join. NEW OPTION: ========== The Link Multiple Tests to Clozapine [CLOZAPINE MULTI TEST LINK] option must be assigned to the person or persons responsible for ensuring that the appropriate data is in place to validate Clozapine testing data. This is usually the Laboratory ADPAC. This option will ask for the local laboratory name that equates to the following seven common test names White Blood Cell Count Absolute Neutrophil Count Neutrophil % Segs (Percent) Bands (Percent) Segs (Absolute Count) Bands (Absolute Count) You will also be asked to fill in the reporting format for each test. Most sites report WBC and Neutrophil results in K/unit format (K/cc or K/cu mm or K/mm-3 or K/mL). For example, WBC equals 5.1. However, some report results as discrete units. For example, WBC equals 5100. This field will allow the site to specify how results are reported. Entries that report in a percentage (such as Neutrophil %, Segs %, and Bands %) should use "Percentage". You may input as many names from the local laboratory definition for each of these tests as needed. Remember that the laboratory may have designed special names for specific test equipment, specific test locations, or specific test conditions, such as manual counts. In fact, if your facility has Clozapine patients with blood samples drawn and tested on a fee-basis at other CLIA (Clinical Laboratory Improvement Amendments) approved labs, it is extremely important for your Laboratory have tests to accept manual input of these tests. Therefore, you should involve laboratory managers or ADPAC (Automated Data Processing Application Coordinator) in selection of these names - both to define the test names currently in use and to create the provision for manual entry of data. Please be certain every possible local laboratory name that represents these tests is entered that relates to each of the seven test names above. Pharmacy dispense will be prevented unless the program can find the needed test results under one of names you identify as an equivalent for each of the seven tests. Security Key: The YSCL AUTHORIZED Security Key is new with this patch. This key must be assigned to each provider authorized to dispense Clozapine. EXAMPLE: CLOZAPINE MULTI TEST LINK [Link Multiple Tests to Clozapine] option Select OPTION NAME: CLOZ 1 CLOZAPINE MULTI TEST LINK Link Multiple Tests to Clozapine 2 CLOZAPINE DATA SERVER YSCLSERVER Clozapine Data Server 3 CLOZAPINE PHARMACY MANAGER PSOL MANAGER Clozapine Pharmacy Manager 4 CLOZAPINE TEST LINK YSCL TEST LINK Clozapine Test Link CHOOSE 1-4: 1 CLOZAPINE MULTI TEST LINK Link Multiple Tests to Clozapine Link Multiple Tests to Clozapine Currently linked Tests: NEUTROPHIL MATURITY, MEAN represents WHITE BLOOD COUNT SEGS represents BANDS % Enter the name of the test for Clozapine: WBC WBC Enter the type of the test for Clozapine: ? Enter a code from the list. Select one of the following: W WHITE BLOOD COUNT A ABSOLUTE NEUTROPHIL COUNT N NEUTROPHIL PERCENT S SEGS % B BANDS % T BANDS ABSOLUTE C SEGS ABSOLUTE Enter the type of the test for Clozapine: WHITE BLOOD COUNT Enter the reporting method of the test for Clozapine: ? Enter a code from the list. Select one of the following: 0 uL 1 K/uL 2 Percent Enter the reporting method of the test for Clozapine: 2 Percent Enter the name of the test for Clozapine: The FDA (Food and Drug Administration) uses White Blood Cell Count and Absolute Neutrophil Count as the definitive tests to verify for Clozapine use, however your lab may report your data under any of the names you enter into these lists. If the WBC and ANC are not directly available, ANC will be calculated from the other data available and presented to Pharmacy (and CPRS (Computerized Patient Record System) during a later revision) at the time of dispense and used to evaluate the safety under FDA limits. Only the most recent WBC will be accepted, and the date and time stamp of the Neutrophil count must match the date and time stamp of the WBC. WHITE BLOOD CELL (WBC) For reference "White Blood Cell Count" is a portion of the total blood content and the sum total of two different kinds of cells - AGRANULOCYTES - those cells which do not have granules that absorb a stain. These cells are subdivided into Lymphocytes and Monocytes. GRANULOCYTES -- those cells which contain granules that absorb a stain. These cells are subdivided into Neutrophils, Basophils, and Eosinophils. Both Agranulocytes and Granulocytes are part of the Total White Blood Cell Count. Therefore, the total WBC is the sum of five different types of cells. WBC as well as its five components are usually expressed as the total number of cells in a cubic centimeter of blood (cc) or cubic millimeter (cu mm or mm-3)or milliliters (mL). WBC usually falls with a range between 4000 and 11,000 but fluctuates for a number of medical reasons. For brevity, WBC results may be divided by 1000 and presented as K/cc or K/cu mm or K/mm-3 or K/mL The five components are similarly expressed as number of the same type OR as a percentage of the total WBC. The sum of counts of the five components of should equal the total WBC OR the sum of the percentages of the five components should equal 100% This test is sometimes also referred to as "Leukocyte Count" Absolute Neutrophil Count (ANC) The Absolute Neutrophil Count is the total number of Neutrophil cells in the total WBC count. The other GRANULOCYTE cells - Basophils and Eosinophils (see White Blood Cell Count above) - are not included in this number. Therefore - a test titled GRANULOCYTES - may not produce the desired result as it may include Basophils and Eosinophils. Since the ANC is a portion of the WBC, it is only valid if it is traceable to the WBC sample drawn at the same date and time. ANC is a count and not a percentage - expressed as WBC with the total number of cells in a cubic centimeter of blood (cc) or cubic millimeter (cu mm or mm-3)or milliliters (mL). Again, this number may be divided by a thousand for brevity. The Absolute Neutrophil Count generally ranges from 1600 to 7700 / but it can ever exceed the WBC count. This test can also be knows as polymorphonuclear cells or PMN's. Neutrophil Percent (Neut%) The Neutrophil Percent is the portion of the total WBC and that is composed of Neutrophil cells, excluding all agranulocytes and other granulocytes. This number is usually between 40% and 70%, but fluctuates for many medical reasons. Since it is reported as a portion of the total WBC, it is only valid if it is traceable to the WBC sample drawn at the same date and time. Neut% is commonly obtained by automatic testing equipment to represent the Neutrophil content in the blood. Neut% is a percentage and not a count - reported in the portion of the WBC. It can be converted into an Absolute Neutrophil Count in the following formula (Neutrophil% / 100) X WBC count). The Neutrophil Percent generally ranges from 37% to 80% and should never exceed 90% of the total WBC count unless special medical conditions are present. SEGS & BANDS The WBC/Granulocyte/Neutrophil cell type can be further subdivided into two types. Mature neutrophils are called SEGS. Immature neutrophils called BANDS also circulate in the blood until they mature into SEGS. The sum of SEGS and BANDS is equal to the ANC of a give WBC count. SEGS and BANDS may be reported as a count, expressed in cc, mm-3, cu mm, or mL. A preceding K indicates the number has been divided by 1000. When SEGS and BANDS are reported as a number, the sum total of SEGS and BANDS equals the total Neutrophil Count (ANC) NOTE that the program needs an identifying test for both SEGS and BANDS. Reporting SEGS without a parallel result from BANDS will result in an error condition that may prevent Pharmacy dispense. This number generally ranges between 1600 and 7700 / cu mm. It should never exceed 90% of the total WBC except under special circumstances. SEGS and BANDS may be reported as a PERCENTAGE of the total WBC. Therefore the total number of neutrophils (ANC) in a give WBC is = total WBC X (% Segs + % Bands). This calculation will be performed by the Pharmacy patch to obtain and ANC when necessary The sum total of SEGS% and BANDS% can never exceed 100. DATA DICTIONARY: =============== CLOZAPINE PATIENT LIST File (#603.01), OVERRIDE DATE field (#3) - This field was added to allow the NCCC more control over the overrides performed at the site. CLOZAPINE PARAMETERS File (#603.03), LOCK DOWN field (#7) - This field was added to allow the NCCC to prevent the dispensing of any Clozapine prescription at a site. CLOZAPINE TESTS file (#603.04) - This file was added to allow the sites to select multiple tests for the WBC and Neutrophil count. Field Field Name Description 603.04,.01 NAME 0;1 FREE TEXT (Required) 603.04,1 TEST NAME 1;0 POINTER Multiple #603.41 603.41,.01 TEST NAME 0;1 POINTER TO LABORATORY TEST FILE (#60) 603.41,1 TEST TYPE 0;2 SET (Required) 'W' FOR WHITE BLOOD COUNT; 'A' FOR ABSOLUTE NEUTROPHIL COUNT; 'N' FOR NEUTROPHIL PERCENT; 'S' FOR SEGS %; 'B' FOR BANDS %; 'T' FOR BANDS ABSOLUTE; 'C' FOR SEGS ABSOLUTE; 603.41,2 REPORTING FORMAT 0;3 SET (Required) '0' FOR Units; '1' FOR K/units; '2' FOR Percentage; INSTALLATION TIME FRAME: ======================= VA DIRECTIVE 2001-023 REQUIRES INSTALLATION OF THIS PATCH WITHIN 30 DAYS FROM THE TIME OF INITIAL RELEASE. REQUESTING SITE: =============== National Clozapine Coordinating Center Test Site(s): ============ West LA Oklahoma Louisville Reference NOIS: ============== NA a ASSOCIATED E3Rs: =============== NA ASSOCIATED REMEDY TICKETS: ========================= NA ROUTINE SUMMARY: ================ The following routines are included in this patch. The second line of each of these routines now looks like: ;;5.01;MENTAL HEALTH;**[patch list]**;Dec 30,1994 Checksum Values Routine Name Before Patch After Patch Patch List ------------ ------------ ----------- ---------- YSCLSERV 25083145 25564583 18,22,26,47, 61,69,74,90 YSCLSRV1 1605367 1606233 61,69,74,90 YSCLSRV2 16840829 24723007 69,90 YSCLSRV3 7345805 24872037 74,90 YSCLTEST 12047382 12378003 18,22,26,47, 61,69,74,90 YSCLTST1 15450428 11839450 18,22,25,26, 47,61,69,74,90 YSCLTST2 11178871 32098862 18,22,26,47 61,69,74,90 YSCLTST3 15031797 25645207 18,22,25,26 47,61,69,74,90 List of preceding patches: 18,22,25,26,47,61,69,74 Sites should use CHECK^XTSUMBLD to verify checksums. Installation Instructions: ========================== NOTE: This KIDS install does not place any options out of service during the install and no existing user options are affected. The site should answer "NO" to all three questions. Note: You may not receive all three prompts at your site. "Want KIDS to Rebuild Menu Trees Upon Completion of Install? YES// NO" "Want KIDS to INHIBIT LOGONs during the install? YES// NO" "Want to DISABLE Scheduled Options, Menu Options, and Protocols? YES// NO" 1. Use the 'INSTALL/CHECK MESSAGE' option on the PackMan menu. This option will load the KIDS package in this message onto your system. 2. The patch has now been loaded into a Transport global on your system. You now need to use KIDS to install the Transport global. On the KIDS menu, under the 'Installation' menu, use the following options: Print Transport Global Compare Transport Global to Current System Verify Checksums in Transport Global Backup a Transport Global 3. Users may remain on the system, installation may be done at any time except during the time scheduled for the Clozapine roll-up. 4. No options need to be placed out of service. 5. Installation time is less than 2 minutes during off peak hours and less than 5 minutes during peak hours. 6. Installation of this patch requires no additional memory space. 7. From the 'Installation Menu' of the KIDS menu, run the option: 'Install Package(s)' Select the package 'YS*5.01*90 and proceed with the install. Routine Information: ==================== The checksums below are new checksums, and can be checked with CHECK1^XTSUMBLD. Routine Name: YSCLSERV Before: B57252811 After: B62056813 **18,22,26,47,61,69,74,90** Routine Name: YSCLSRV1 Before: B2175459 After: B2228786 **61,69,74,90** Routine Name: YSCLSRV2 Before: B26824513 After: B45550399 **69,90** Routine Name: YSCLSRV3 Before: B8766560 After: B46877449 **74,90** Routine Name: YSCLTEST Before: B20062931 After: B20876343 **18,22,26,47,61,69,74,90** Routine Name: YSCLTST1 Before: B27542972 After: B19103633 **18,22,25,26,47,61,69,74,90** Routine Name: YSCLTST2 Before: B19135665 After: B77542663 **18,22,26,47,61,69,74,90** Routine Name: YSCLTST3 Before: B27477031 After: B59491458 **18,22,25,26,47,61,69,74,90** ============================================================================= User Information: Entered By : MORTON,RANDY Date Entered : JUN 16, 2005 Completed By: KIRBY,ROSE Date Completed: SEP 11, 2006 Released By : LECLAIR,RAY Date Released : SEP 14, 2006 ============================================================================= Packman Mail Message: ===================== $END TXT