Sysmex® CS Systems Using Quality Control Features to Prepare for Lot Rollover Part 1

Sysmex CS 2500 and CS 5100 systems. Using quality control features to prepare for lot role over video part one. Implementation of PT and PTT new reagent anun assayed control lots. The sections covered in part one of the using quality control features to prepare for loud rollover video include verifying that PTN PTN are listed in the job list. Entering new QC lots in the reagent lot master registering new QC lots to QC chart. Viewing charts. Current versus new. Establishing new QC ranges. Steps to go live. Entering the ISI Ann normal values for new PT lot and change lot. Verifying that PTN and PTN are listed in the job list. Before proceeding auto QC for PT and PTT should be deactivated prior to starting the lot rollover process. A system reboot is required for this to take effect. This example will show the steps involved using a CS 2500 system. Exceptions needed for CS 5100 systems will be explicitly brought to attention. Navigate to job list, scroll to the right to view all assays listed. Identify if PTN and PTN are available for this demonstration. We will proceed as if the assays are not available. From menu, navigate to assay group settings. Note sysmex CS 5100 users will first need to select settings before accessing as a group settings from the Assay Group list. Select PTN if not already selected, select the valid checkbox, then save. From the essay group list, select PTN if not already selected, select the valid checkbox, then save. Select close the restart alert message appears, select OK. Select the Red X to close out of the software. Select OK on the confirmation box. Turn off the instrument. Restart the software using the CS startup icon. Turn on the system and log on to the software. Navigate to job list to add assays to the job list. First select more to the right until customize is an option. Select customize, locate and select PTN on the parameter list. Then highlight the last parameter on the displayed parameter list. Select add to add PTN to the displayed parameter list. Locate and select PTN on the parameter list. Then highlight the last parameter on the displayed parameter list. Select add to add PTN to the displayed parameter list. Note to add a parameter back to the parameter list, highlight it, then select delete. Select OK. Scroll the job list to the right to confirm that PTN and PTN are now visible. If the assays were not previously visible, this is the first point at which they would be. Entering new QC lots in the reagent lot master. From menu select reagent, lot Master in the reagent lot. Master setup popup window. Verify that new in an new AF SL are listed. To add a new QC lot, click in the lot number field. Scan the two dekk vile barcode or manually enter the six digit Siemens Healthineers lot number. Click in the expiration date field. Note an incorrect default date is automatically entered if the date is not manually entered. Enter the expiration date from the file using the calendar. Select add to register the new QC lot number to the reagent lot master set up list. Repeat for each new level of QC. Select save when complete, then close. Registering new QC lots to QC chart. Select QC chart. Select the lot role tab, then select the first chart listed PTN site role one. Select more until add lot is displayed if needed. Select add lot. Select the dropdown menu, arrow to the right of lot number and select the recently added lot number. Verify that the use QC barcode checkbox is selected. Disable use preset if selected. Select next, this is the assay parameter selection screen. All assays that use side draw one are selected. Do not make any changes to this screen. Select next. This is the QC chart settings screen. Do not make any changes to this screen at this time. Select next. From the QC barcode setting screen, select QC 11 to the right of side trial one. Select next from the confirmation of the settings completion screen. Select OK to save. For sysmex CS 5100 systems, select complete to save. Repeat these steps to add side role 3. Viewing charts current versus new. From QC chart, select more until switch display is available. Select switch display. Select new. Select the lot role tab. All new lots are displayed on the right side of the charts. Select switch display select current. From the routine tab, you can view the current PT and PTT charts. Establishing new QC range is to load a new reagent. First select an empty green rack from the reagent table inner wheel. Place the new PT reagent in position two of the reagent rack, then place the new PTT reagent in position one of the same reagent rack. Be sure that both of the bottles bar codes are hidden. Load the rack to the reagent table and allow the bar codes to be red. Highlight position 2 showing the red? And select Edit Reagent info. Select new in from the reagent list. Click in the lot number field an select the listed lot number. Click in the file field, select the correct file size from the list. Select OK to save the information. Highlight position one showing the red? And select Edit Reagent info. So like new AF SL from the reagent list. Click in the lot number field and select the listed lot number. Click in the vial field, select the correct file size from the list. Select OK to save the information. Select new in on the current reagent screen, then select lot group settings on the right. Confirm that the box below used in sample analysis is checked. This gives the instrument permission to run this reagent for the assay. Select OK. After selecting new AFL repeat the previous steps performed for new end. To load nuked files, first select a yellow seawrack place QC vials containing LD mini cups with bar codes facing out to be read. Load the rack onto the reagent table. Select OK when prompted to have the barcodes read. Select order then switch order from the right select Holder QC order. Select order entry. Select the radio button for QC 01 to QC 20 on the Left. Select QC 11 from the list. Select PTN and PTN from the test list. Select the down arrow. Repeat the previous steps to order QC 13 for PTN PTN. Once both tests are selected, do not select the down arrow, select OK. Press start to run your new QC. Steps to go live. From menu select reagent lockmaster. Select import. Select barcode. Scan the barcode on the package. Insert sheet with the 2D barcode reader for PT Inoven. Select save on the barcode reading results popup. Select exit for act in FL. The package insert is not used. Click in the lot number field. Enter the six digit lot number or scan the barcode on the file. Place the cursor in the expiration date field. Enter the expiration date using the calendar. Select add, then save. To delete the old PT and PTT lot numbers, select the old lots from the list and select delete, then OK to confirm. Select close when complete. Remove old lots of reagent and QC from the analyzer reagent table and load new QC. Load PT Innova NAFL with barcodes visible. The system must read the barcodes. Entering the ISI an normal values for new PT lot. Select calibration curve. Select change. Select PT. Select this specific lot number. Select edit from the right. Select the lot Master key to enter the ISI value or it can be manually entered. Select yes place cursor in the normal value field and enter the value using the keypad. Press enter. Select OK. Select validate on the right. Select OK. Printing current QC and making new lots current. Select QC chart. Select the routine tab if not already selected, then select switch display. And choose current. Select print report under output Target, Select active tab. Select date range. And enter the date range select list. Select print. Notes your historical as D for your Q see this as D can be used with your new lots. Select the lot role tab. Select switch display, then select new. Select the PTN side Shrawan Levi Jennings chart. The statistics are shown to the right of the chart. Print PTN and PTN data. If a hard copy is desired. Change lot. With the PTN site role, one chart selected. Select change lot. The new QC lot number is displayed. This is the lot that will be switched to current. Select next on the assay parameter selection page. Confirm that monitor is selected. Select next from the QC chart settings screen. Select auto calc to calculate PTN and PTN. Select 1D target upper lower limit upper lower stop limit and target all assay parameters. Select OK. A warning box appears. Select OK. Highlight PT and select detailed settings. Repeat steps for PT. Adamin for fibrinogen. If you do not have points to auto calculate, highlight fibrinogen C and select detailed settings. Enter a target or mean. Select OK. Select next from the QC barcode setting screen. Change the QC 01 lot by selecting the QC 01 button. This action changes QC 01 to your new side role one lot number. Select next select OK on the confirmation of the settings completion screen CS 5100 users will select complete. Repeat the previous change lot steps for side role 3. From QC chart, select QC barcode settings on the right. Clear out QC 11 and QC 13 by using the corresponding drop down menus. Select OK, navigate to the routine tab to view the charts that were just changed. Order QC for PT and PTT using QC01 and QC03.

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Date Meanu e an 553604 Down 61.0 11.5 53.5 5.0 27.2 6 Confirmation af the ßConfirmation of the 6 Con A3-2 Change Chancel Cancel Chancel 01 21 24 A27C 5286 30 13 2037 20 20 01 24 24 25 28 11 24 28 5286 25 20 21 02/01 Review John 304 rubnitor Patient Name DT Reagent ID Reagent Reagent:ID Reagent Ty Parameters Parameter List 0K 09/314/2017 11/20/2017 01/31/2018 02/01/2018 Settings Completion Date: Data: Data SD aa ISD 1.1 127.1 3.4 39.6 3.5 31.1 55.5 --/--/---- --/--/-- oc08 ocol oc02 OC18 OCII OC14 A2-2 30 38 31 37 Clean I C lean 31 30 37 01 23 5286 23.7 22 Delete -Entering the ISI and Normal Values for new PT lot Sep F D TN sec 48 A3-1 512.3 64.0 61.0 PC ci sec pc PC cl sec Patient Name More DI-I Set Date Set Time 02/01 8 02/01 Review John Down 000050-02 08:28 03:28 08:24 11.A V INN N sec 9:07 AM 8:29 AM AM cv 7.0 11.5 5.0 66.0 PC cl sec INN Sam le Comment Reagent Type Reagent Master Reagent ID Reagent Iype Reagent IDpe Reagent Name (1/3) (2/3) Citra 1 Citrol a Oitrol 3 Citral 1 Citra p T FSL Setting Date: Setting Time: ALL names and data of patients, parameters and configuration dependent designations are fictional and examples ac08 acia New New AFSL AFSL V INN N sec PC cl sec 10 1.0 20 print. Maint. Format -Change Lot 02/01 e 09/20/2019 02/01 Review 11 A Save Scave PNP only. Reagent Master Reagent Type Reagent ID Reagent Name Reagent IDme Reagent IDpe Reagent Ty Reagent Iype Ready Control Control, Citrol 1 Citrol a Control Start. Time Set Time Setting Time: 548483 Current New p I—TN Control, Citrol 1 Control A3-1 A3-5 A3-2 A4—5 SB-4 02/01 02/01/2018 Re view Data Sample 51 02/01 8 02/01 e r&nufacturer NE nufacturer renufacturer FSL Siemens use Barcode List(2 ac20 acco Chancel line Changel Cancel lines Inn Elap. Time Start. Time O Hours Normal Value 38 30 28 3.7 10.5 sec 185 12.1 sec More Detaiied Settings 74.3 Chancel Changel Changei A2-3 1.1 Re view Review Dave Dawe cave Date Data os:ao McAfee Lexmark Detailed settings for (3/3) (2/3) (1/3) 62.3 62-6 62.6 A2-6 3.0 629.6 (2/3) Select the radio button 61.2 sec 62.4 sec 11.0 sec 60.1 sec .9 sec Clean Meanu A2-5 12.1 C2-5 C2-6 C206 use preset e an OK 0K C.ance! Ca ncel Change! 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Delete Save Date: Data: N/bnth NYEnth 02/12/201 e 01/31/2018 02/12/201 g 02/812/2018 01/312/2018 02/312/2018 06/22/2019 02/319/2022 -01 01/21/2019 09/20/2019 01/31/2018 al 9 14. 6ml_ 14. 14 Reagent Lot Master Reagent Master Reagent Name Reagent Type Reagent Lot Master Setup Reagent ID Re Assay Group Settings 4 OC Barcode Settings Formula setting ISI Value Inn W nufecturer's Auto Detailed Condition Settings Completion OK 0K Cancel 57.00 50.0 70.0 570.0 10.0 7.0 09/21/2019 09/21/2018 Set Date Exp. Date 01 Copy A2-3 A3-1 A4-6 A3-5 A2-5 SB-4 A4—5 SB-4 SB-5 C2-l DB-2 S3-4 5.00 Cancel Caccel Close C lose Up AFSL FSL OK Charte Cancel Changel Chancei List test Load Lot wester Lot Å,kster Charte Cancel Changel Reangent PT Up Henkestr. 127 9.2 mL Close C lose C lose C lean Close Delete Delete Report. Load Back Bacv 8æck Next Change Cancrol, Cancel C lose Close Report. Export. Add Load print. Maint. Save C lose Clean Close Down Recycle Bin Down W/kasurement Note: QC Ranges should be established using reagents and QC exactly the same way they typically are used. ropasurement P&asurement Wasurement Wopasurement Seq uence Note: Sysmex CS 5100 users will first need to select Consider age of QC/reagent, claimed onboard stability, claimed reconstituted stability, etc . Have different CS Display Display CS Lab Note. Select Detailed Settings to input values. Note: Sysmex CS 5100 will select Complete. technologists reconstitute reagents/QC. At least 30 points for each level of QC should be collected. technologists reconstitute reagents/QC. At Least 30 points for each level of QC should be collected. Note: 13:13 13:14 14:17 14:19 14:27 14:28 14:40 10:09 14:14 14:18 13:25 14:41 14:20 14:11 14:15 14:26 13:51 13:251 13:50 14:42 13:55 13:12 10:12 10:16 13:59 12:36 14:16 14:29 12:37 10-03 11:10 10:27 12/31 10:46 11:05 11:59 11:56 12:35 11:54 11:44 10:42 10:31 12:46 14:07 10:15 11:07 10:30 12:34 10:25 10:04 10:34 14.5 11:57 12:42 10:44 11:55 11:46 10:52 10:49 11:58 10:45 12:47 12:43 12:44 12:53 9:41 9:59 I Ready Ready Processing Reagent 13:22 13:38 12:39 13:06 13:20 10:06 10:08 10:29 10:32 12:33 11 •10 12:32 11:09 14:08