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Program Overview
Program Description The Insight Interlaboratory Quality Assessment Program provides a report of approximately 40 days of analyzer performance. Each analyzer is compared to the peer group for on-average accuracy and over time a 12-month review of past performance will be provided. The program is simple to use. Calendars with period end and data due dates are provided when you enroll. Save QC files to disk, removable disk drive, or desktop then upload your data to the Insight Quality Assessment Program on the Sysmex Website. Contact Info. Voice: e-Mail: 847-996-4563 insight@sysmex.com
Sysmex e-CHECK, plt-CHECK, and SE-CHECK controls can be analyzed in Manual (Open) aspiration mode, Closed aspiration mode or both (in separate files). Each mode generates a separate peer group. e-CHECK (XS) is not separated into Open and Closed modes.
Submit Data to Correct Peer Group Data submitted as Open Mode aspiration will be processed with the Open mode peer group and data submitted as Closed Mode aspiration will be processed with the Closed mode peer group. For this reason, it is imperative that the correct aspiration mode is chosen when saving data.
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Timelines
Timeframe All e-CHECK, e-CHECK (XE) and e-CHECK (XS) Insight schedules are derived from the product s 84-day lot life. All SE-CHECK Insight schedules are derived from the product s 75-day lot life. plt-CHECK Insight schedules are derived from the product s 83day lot life For this reason, new lots arrive and control data is due at different weeks each month. Please Use Calendar Use the Insight calendar provided when you enroll. This is the only reliable way to know when to expect a new lot and when control data is due to be uploaded to the Insight area of the Sysmex Website. e-CHECK, e-CHECK (XE), e-CHECK (XS) lots are shipped every 56 days. SE-CHECK lots are shipped are shipped every 49 days. plt-CHECK lots are shipped every 70 days. Product Life The interval from ship date to expiration date is 84 days for e-CHECK, e-CHECK (XE) and e-CHECK (XS). SE-CHECK product life is 60 days. plt-CHECK product life is 83 days. Data Due Dates The QC Data Due Dates for each product are provided on the assay sheets and on the Data Due Date Calendar found on the Insight area of the Sysmex Website. QC Data needs to be uploaded to the Insight Quality Assessment Section on the Sysmex Website by the Data Due Date. The Data Due Date is three-five days after the lot/period end date. An analyzer period report will be generated on control data arriving prior to the Last Date to Submit data. Control data arriving after the Last Date to Submit will not be used in the generation of the group statistics. Participants submitting late data need to retrieve the Insight Report from the website.
Ship Date
Internet/Website
Late Data
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XE-Series and XT-Series Analyzers Detector Control Parameters File Limit Range%
Enter the Limit Range% values listed below for Level 1, Level 2 and Level 3 and for both Open/Manual and Closed Mode. Once entered, these values should not be changed.
DCPs/Service Parameters DIFF-X DIFF-Y BASO-X BASO-Y IMI# IMIDC IMIRF NRBC-X NRBC-Y RBC-O HFF MFR LFR RBC-X RBC-Y NRBC% PDW PLCR PCT Limit Range% 8 68 15 21 80 20 43 14 14 29 217 120 56 64 17 999 999 999 999 XE-2100 X X X X X X X X X X X X X X X X X X X XE-2100L X X X X X X X X X XE-2100D X X X X XT-2000i X X X X XT-1800i X X X X XE-5000 X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X
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Parameter RBC HGB HCT MCV MCH MCHC PLT RDW-SD RDW-CV MPV WBC WBC-D NEUT% LYMPH% MONO% EO% BASO% NEUT# LYMPH# MONO# EO# BASO# NRBC# NRBC% PLT-O RET# RET% IRF IG# IG% HPC RET-HE IPF%
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Level 1 Level 2 Level 3 Parameter Limit % Limit % Limit % RBC 4.0 3.5 3.5 HGB 5.5 5.0 5.0 HCT 4.5 4.0 4.0 MCV 4.5 4. 4.0 MCH 5.5 5.0 5.0 MCHC 6.0 5.0 5.0 PLT 12.0 8.0 11.5 RDW-SD 5.0 4.7 4.8 RDW-CV 4.0 4.2 4.0 MPV 6.0 5.6 5.8 WBC-C 7.0 6.2 6.4 WBC-D 7.0 6.2 6.4 NEUT% 9.0 6.7 6.4 LYMPH% 8.5 6.4 6.2 MONO% 22.0 18.0 20.2 EO% 22.2 22.9 22.4 BASO% 26.4 23.9 22.8 NEUT# 12.0 8.4 7.7 LYPH# 12.5 8.2 12.2 MONO# 24.0 19.2 20.8 EO# 22.4 23.8 22.6 BASO# 26.3 23.9 22.9 INPUT THE VALUES BELOW AND DON T CHANGE DIFF-X 999 999 999 DIFF-Y 999 999 999 FSC-X 999 999 999
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Hard Copy Recommended Hard copy documentation is recommended to ensure availability during a laboratory inspection.
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Select Material, Level, Mode and Lot The left half of the [SysmexInsight] window is labeled Select QD Data. This area allows selection of a control Material, Level, Analyzer Mode, Lot and Instrument ID. Make appropriate selections as follows. Material: Click on the [ ] button next to Material: to pull down a list of items and select e-CHECK for XE analyzers. Select Control for XT analyzers. Level: Click on the [ ] button next to Level: to pull down a list and click on Level 1. Ana. Mode: Click on the [ ] button to pull down list of items and select the appropriate aspiration mode by clicking on Closed or Manual. Lot: Select either Current or New as required to obtain the desired e-CHECK lot number for this reporting period.
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Save the Correct Lot The right half of the [SysmexInsight] window displays lot information under the QC Data Info. heading. Verify that this is the correct lot number of e-CHECK control data for this reporting period. Save Files to Disk or USB Memory Stick: NOTE: When saving Closed and Manual mode QC files on the same disk or USB Device, the files need to be renamed to distinguish Closed mode from Manual mode files. Save all desired Closed files then rename the files with a C at the beginning of the file name. Save all desired Manual files then rename the files with an M at the beginning of the file name. Rename File Instructions appear below. Save Files to Disk 1. Move the mouse pointer to the [Save] button and click once. An hour-glass appears while the Save is being executed. 2. When save is finished, click on the [ ] button next to Level: to pull down list and click on Level 2. Verify QC Data Info. and click the [Save] button again. 3. When save is finished, click on the [ ] button next to Level: to pull down list and click on Level 3. Verify QC Data Info. and click the [Save] button again. 4. Go to Floppy Drive to verify files are saved. Left click on (Show Desktop). Located to the right of the Start icon on the analyzer IPU. Double click on My Computer. Double click on Floppy A: Saved files appear.
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Rename Files: 1. After all desired Closed or Manual files are saved. Left click on (Show Desktop). Located to the right of the Start icon on the analyzer IPU. 2. Double click on My Computer. 3. Double click on Floppy A: 4. Left click to highlight one file. Rename one file at a time. 5. Right click/Choose rename file. 6. For example, rename Closed file: QC-730370801.ins to CQC-730370801.ins 7. For example, rename Manual file: QC-730370801.ins to MQC-730370801.ins Save Files to USB Memory Stick 1. Move the mouse pointer to the [Save] button and click once. 2. When Please insert disk into Drive A: appears, click Cancel. 3. In the Save In box, click on the [ ] button to locate Removable Disk Drive. The name of the removable device, for example, Data Traveler (D:), may appear. Click on Removable Disk drive. 4. Click Save. 5. When Save is complete, click on [ ] to choose another level. Verify QC Data Info. 6. Repeat steps 1-6 to save additional level. 7. Go to Removable Drive to verify files are present. Left click on (Show Desktop). Located to the right of the Start icon on the analyzer IPU. Double click on My Computer. Double click on Removable Device Drive. Saved files appear. 8. NOTE: If message, write protected appears, flip switch on side of device. Switch location depends on manufacturer. Rename Files: 1. After all desired Closed or Manual files are saved. Left click on (Show Desktop). Located to the right of the Start icon on the analyzer IPU. 2. Double click on My Computer. 3. Double click on Removable Device: 4. Left click to highlight one file. Rename one file at a time. 5. Right click/Choose rename file. 6. For example, rename Closed file: QC-730370801.ins to CQC-730370801.ins. 7. For example, rename Manual file: QC-730370801.ins to MQC-730370801.ins
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Remove USB Memory Stick Caution: Data may not be saved on device if the stop process is not used. 1. 2. 3. Click on Removable Device Icon (lower right-hand side of desktop). Click Stop USB Mass Storage Device. Okay. Remove Device.
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Go to Removable Drive to verify files are present. Click [-] Upper right corner to minimize screen. Double click on My Computer. Double click on Removable Disk Drive: Saved files appear.
Remove USB Memory Stick Caution: Data may not be saved on device if the stop process is not used. 1. Click on Removable Device Icon (lower right-hand side of desktop). 2. Click Stop USB Mass Storage Device. 3. Okay. Remove Device. 4. If Okay to Remove does not appear, shut down analyzer before removing the device.
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Locate Insight Data Folder on Desktop. Save in: arrow down to find Desktop. Open Insight Data Folder. Save QC to Insight Data Folder. Use arrow down key to save each lot/level. To save both Open/Manual and Closed Modes, it is necessary to have two Insight folders or to change the file name when saving. Re-saving same file name with additional data, click overwrite/okay. Problem with uploaded data. Delete file(s) from folder. Make corrections on analyzer. Re-save data using steps 1 through 3.
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3. Select Save To re-save the same file name with additional data, highlight file. Save. Replace? Yes. 4. Problem with uploaded data. Delete file(s) from folder. Make corrections on analyzer. Resave data using steps 1 through 3. 5. Repeat steps 1 through 3 to save additional lot/levels.
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