InsightParticipant Overview Guide Contents: Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Program Overview Timelines Types of Reports Report Turn Around Time Limit Range% QC Files DCP/Service Parameters File Limit% Reportable Suggested QC Limit Range% for XE-2100 Series Reportable Suggested QC Limit Range% for XE-5000 Reportable Suggested QC Limit Range% for SE-Series Reportable Suggested QC Limit Range% for XT-Series Suggested Limit Range% for XS-Series Control Data Handling Document Control Data Before Deletion General Information on Saving QC Files SNCS Save and Upload QC Files Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 14-18 Page 18-20 Document No: WI-2493A Rev. 13 Page 1 of 20 Effective Date: 1/7/09 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 [email protected] Each Mode Is A Peer Group 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. Document No: WI-2493A Rev. 13 Page 2 of 20 Effective Date: 1/7/09 Control data arriving after the Last Date to Submit will not be used in the generation of the group statistics. SE-CHECK product life is 60 days. Participants submitting late data need to retrieve the Insight Report from the website. e-CHECK (XE). Product Life The interval from ship date to expiration date is 84 days for e-CHECK. new lots arrive and control data is due at different weeks each month. The Data Due Date is three-five days after the lot/period end date. Ship Date Internet/Website Late Data Document No: WI-2493A Rev. e-CHECK (XS) lots are shipped every 56 days. 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 (XE) and e-CHECK (XS). e-CHECK (XE) and e-CHECK (XS) Insight schedules are derived from the product s 84-day lot life. 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. plt-CHECK lots are shipped every 70 days.Timelines Timeframe All e-CHECK. QC Data needs to be uploaded to the Insight Quality Assessment Section on the Sysmex Website by the Data Due Date. SE-CHECK lots are shipped are shipped every 49 days. plt-CHECK Insight schedules are derived from the product s 83day lot life For this reason. e-CHECK. 13 Page 3 of 20 Effective Date: 1/7/09 . All SE-CHECK Insight schedules are derived from the product s 75-day lot life. An analyzer period report will be generated on control data arriving prior to the Last Date to Submit data. After sufficient lot/period data has been received. Data can be submitted at any time during a lot s life cycle. Cumulative Report At the end of the second period. results from approximately one year of statistics will be available. Lot-To-Date Report Lot-To-Date reports can be obtained from the Insight section on the Sysmex Website immediately after the data is submitted.Types of Reports Available First Period Report Data uploaded by the first Data Due Date generates a First Period Report using data from approximately the first 40 days of the lot. a Cumulative Report is generated using data from the First and Second Periods. Shift 2 and Shift 3) to the peer group is generated. Second Period Report Data uploaded by the second Data Due Date generates a Second Period Report using data from approximately the last 40 days of the lot. Document No: WI-2493A Rev. a blank column will appear for that lot. The Group Report is available at any time during the life of the lot. Shift Reports For laboratories requesting shift reports. 13 Page 4 of 20 Effective Date: 1/7/09 . If data is not submitted for both Periods. These reports provide a management tool to determine if control processing is consistent across shifts. a comparison of each work shift (Shift 1. A message indicating how many labs have submitted data will appear. Group Report Group peer statistics for comparison of your analyzer s mean and CV are available on the website to participants who do not submit QC data. Document No: WI-2493A Rev. e-Mailed Reports Participants who have provided e-mail addresses will have a First Period Report sent via e-mail 24 hours after the Last Date to Submit Period 1 Data and a Second Period Report sent via e-mail 24 hours after the Last Date to Submit Period 2 Data. Participants submitting data late will not be e-mailed reports and will need to retrieve their reports from the website.Report Turn Around Time Website Lot-to-Date Lot-to-Date Reports can be retrieved from the Insight Users Section of the Sysmex Website immediately after uploading the data. Participants' not submitting data may retrieve Group Reports from the Insight area of the Sysmex Website any time during the life of the lot. Period Reports First and Second Period Reports can be retrieved from the Sysmex Website the day after the Last Date to Submit Data. 13 Page 5 of 20 Effective Date: 1/7/09 . Participants without e-mail addresses can retrieve reports from the website. Lot closing will take place the day after the Last Date to Submit. Cumulative Reports Cumulative Reports can be retrieved from the Insight Users Section of the Sysmex Website approximately six days after the lot expiration date. Do not use CLIA criteria or Medical Decision Limits Limits that are based on CLIA proficiency testing criteria for acceptable performance or so called Medical Decision Limits reduce error detection to the point of missing medically important errors. therefore. these control limits automatically will be applied to each new lot. Refer to Operator s Manual for instructions on how to enter QC File Limits. Enter Limits For Each Mode s QC Files If control is analyzed using both Manual (Open) and Closed modes. Once entered these values should not be changed. These have no scientific justification for use as control limits. New Analyzers Use Suggested Limits Initially input the reportable parameters Suggested File limits in your analyzer s control files. once for each level in each mode. They only need to be changed when updated by the laboratory as necessary or in six months when the laboratory can calculate analyzer specific control limits. not applicable as control file limits. 13 Page 6 of 20 Effective Date: 1/7/09 . They are not a measure of typical within-analyzer imprecision and are. limits will have to be entered twice. Document No: WI-2493A Rev. Once entered. What Not To Do Never use Assay Sheet Expected Ranges Expected Ranges represent typical variance in accuracy between analyzers.Limit Range% For QC Files Detector Control/ Service Parameters Limit Range% values for the detector control/service parameters are provided by analyzer series. See page 7. They are intended to ensure reasonable error detection capability and minimal false rejection rates until analyzer specific control limits can be established. 13 Page 7 of 20 Effective Date: 1/7/09 . Level 3 62 20 51 21 40 15 22 999 Document No: WI-2493A Rev. Level 2 and Level 3 and for both Open/Manual and Closed Mode. these values should not be changed. Level 2.XE-Series and XT-Series Analyzers Detector Control Parameters File Limit Range% Enter the Limit Range% values listed below for Level 1. These values will remain in the lot files and once entered should not be change. Once entered. 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 SE-Series Analyzers Detector Control Parameters File Limit Range% Enter the Limit Range% values listed below for Level 1. DCP s IMI# IMIDC IMIRF GRANDC GRANRF EO-MFV BA-MFV NRBC% Limit Range% Level 1. Level 2 and Level 3. 9 13.5 11.7 Suggested QC Limit Range% for plt-CHECK The limits provided below are for use on the XE-2100D BB when using the plt-CHECK product.1 23.9 24.2 11.4 3.4 RDW-CV 4.9 MCHC 5.2 11.5 RET% 22.4 18.8 2.6 14.5 RET# 22.6 4.7 MPV 7.8 MCV 3.6 4. 13 Page 8 of 20 Effective Date: 1/7/09 .8 4.5 8.7 6.5 IG% 13. Limits provided here represent three times the average analyzer s cumulative CV%.3 12.3 4.2 9.2 NRBC% NA NA NA PLT-O 19. These limits are only for use in the interim while data is collected to establish your analyzer-specific control limits.8 9.5 EO% 24.7 MONO% 35.6 19.4 IRF 43 41.4 IPF% 13.4 3.2 12.3 13.4 21.9 10 LYMPH# 15.3 9.8 PLT 14.1 NRBC# 13 11.5 21.1 NEUT# 14.5 23.4 3.3 3.4 3.1 IG# 16 14.4 EO# 26.5 RDW-SD 4. Use Prior To Establishing Analyzer Specific Limits Level 1 Level 2 Level 3 Parameter Limit % Limit % Limit % RBC 3.6 4.9 8.5 8.8 BASO% 7.6 6.4 MCH 4.2 4.5 HGB 4.4 19.9 12.1 8.5 Document No: WI-2493A Rev.0 HPC 15.8 21.2 12.6 3.8 22.8 8.9 3.8 RET-HE 12.2 18.9 3.1 11.4 10.4 BASO# 12.7 LYMPH% 11.1 47.3 7.2 4.6 4.7 10.0 MONO# 37.5 3.4 2.6 3.2 23.Suggested QC Limit Range% for XE-2100 Series The limits provided below are for use on the XE-Series analyzers.9 WBC 10.8 HCT 5.4 8.0 NEUT% 9.5 5. Use Prior to Establishing Analyzer Specific Limits Level 1 Limit% Level 2 Limit % 12. 5 21.8 4.4 26.4 10.8 3.6 14.2 12.3 18.6 3.1 21. Use Prior To Establishing Analyzer Specific Limits Level 1 Limit % 3.5 23.6 9.2 4.5 8.4 3.8 4.8 9.9 4.2 14.5 8.7 3.8 11.5 12.1 41.3 5. Limits provided here represent three times the average analyzer s cumulative CV%.4 23.5 9.Suggested QC File Limits for XE-5000 The limits provided below are for use on the XE-5000 analyzers.0 19.6 5.5 5.6 4.6 Level 3 Limit % 3.7 13.7 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% Document No: WI-2493A Rev.2 37.3 3.7 8.8 5.5 10.4 15.4 3.6 4.2 43 16 13.5 15.3 11.6 11.9 4.8 36.5 24.9 13.9 12.4 47.6 6.2 Level 2 Limit % 3.6 2.4 35.1 11.9 8.8 4.7 13.9 4.4 7.7 7.9 15.8 7.5 4.1 12.7 19.8 8.6 22.1 14.2 18.4 3.1 35.3 22.4 14.2 10.4 2.2 12.5 23.4 24.1 11.3 19.4 4.4 8.4 22. These limits are only for use in the interim while data is collected to establish your analyzer-specific control limits.9 12.0 21. 13 Page 9 of 20 Effective Date: 1/7/09 .0 6.5 3.1 10 11.8 3.9 7.8 16.0 4.5 4. 3 2.9 54.8 4.7 48.8 3.3 4.7 3.5 56.6 10.4 7.7 Document No: WI-2493A Rev.1 3.Suggested QC File Limit Range% for SE-Series The limits provided below are for use on the SE-Series analyzers.9 6.7 3.6 8.8 53.3 3.7 18.7 L3 Limit% 6.9 7.6 3.9 49.9 7.4 7.7 4.5 2.4 10. Use for Reportable Parameters Prior To Establishing Analyzer Specific Limits Parameter WBC RBC HGB HCT MCV MCH MCHC RDW-SD RDW-CV PLT MPV NEUT# LYMPH# MONO# EO# BASO# NEUT% LYMPH% MONO% EO% BASO% L1 Limit% 8.9 2.9 9.6 4.7 1.4 1.2 10.7 12.6 16.2 10.6 4.5 8. Limits provided here represent three times the average analyzer s cumulative CV%.3 13.7 3.5 19.0 3.6 3.2 2.4 13.6 3.4 5.4 20.7 16. These limits are only for use in the interim while collecting data to establish your analyzer-specific control limits.3 4.9 1.9 14.2 8.3 17.8 2. 13 Page 10 of 20 Effective Date: 1/7/09 .6 4.6 8.0 19.7 8.3 13.7 L2 Limit% 6.7 56.3 10. 3 10.7 3.1 18.6 7.1 5.9 4.0 19.9 5.8 22.3 16 13.8 5.6 6.1 36.4 Document No: WI-2493A Rev.4 3.8 20.2 12.6 7.2 35.6 5.2 30.2 5. Limits provided here represent three times the average analyzer s cumulative CV%.8 4.6 9.9 Level 2 Limit % 4.3 5.3 35.9 21.1 14.9 13.8 34.1 37.3 4.8 5.5 6.5 23.3 4.2 2.2 Level 3 Limit % 4.7 13.0 4.1 49.4 49.1 9.1 9.7 11.0 11. These limits are only for use in the interim while collecting data to establish your analyzer-specific control limits.Suggested QC File Limit Range% for XT-Series The limits provided below are for use on the XT-Series analyzers.8 34. Use for Reportable Parameters Prior To Establishing Analyzer Specific Limits Parameter RBC HGB HCT MCV MCH MCHC PLT RDW-SD RDW-CV MPV WBC NEUT% LYMPH% MONO% EO% BASO% NEUT# LYPH# MONO# EO# BASO# PLT-O RET# RET% IRF IG# IG% RET-HE Level 1 Limit % 4.4 11.5 3.7 5.7 11.9 14.4 9.2 23.0 5.4 18.2 33.3 25.8 4.4 4.6 5.9 12.3 6.5 13.5 4.7 21.3 3.5 13.1 28.5 10.7 10.4 11.4 25.4 17.3 4.9 9.3 20.0 21.2 63.6 8.8 11.8 6. 13 Page 11 of 20 Effective Date: 1/7/09 . 4 NEUT% 9.0 MCV 4.5 4.8 EO# 22.5 5.2 EO% 22.2 6.5 6.4 7. These limits are only for use in the interim while collecting data to establish your analyzer-specific control limits. Limits provided here represent three times the average analyzer s cumulative CV%.0 PLT 12.0 MPV 6.0 6.0 3.0 5. 4.4 6.2 MONO% 22.8 WBC-C 7.7 4. 13 Page 12 of 20 Effective Date: 1/7/09 .3 23.0 5.2 22.4 23.0 MCH 5.0 4.8 22.2 4.0 5.0 11.0 8.2 20.0 20.4 LYMPH% 8.0 18.5 8.5 3.0 5.9 22.0 8.9 INPUT THE VALUES BELOW AND DON T CHANGE DIFF-X 999 999 999 DIFF-Y 999 999 999 FSC-X 999 999 999 Document No: WI-2493A Rev.9 22.4 WBC-D 7.2 6. Use for Reportable Parameters Prior To Establishing Analyzer Specific Limits Level 1 Level 2 Level 3 Parameter Limit % Limit % Limit % RBC 4.0 4.2 MONO# 24.5 4.2 12.0 4.9 22.6 BASO# 26.5 5.0 6.0 5.7 LYPH# 12.7 6.0 19.5 RDW-SD 5.0 6.0 HCT 4.8 RDW-CV 4.6 5.5 HGB 5.8 NEUT# 12.4 BASO% 26.0 MCHC 6.Suggested QC File Limit Range% for XS-Series The limits provided below are for use on the XS-Series analyzers.4 23. Review Requirement At some point before QC files are submitted. 13 Page 13 of 20 Effective Date: 1/7/09 . When to Submit Data Control results that exceed control limits are submitted when no cause for the out-of-control result can be assigned. When no known cause can be assigned. the reward is in an Analyzer Report that provides a better assessment of analyzer operation that requires less time to review. however. the files should be screened to delete out-of-control data that was due to a known cause. The Analyzer Report can perform these functions best when control file data is reviewed and edited before submission to Insight. These errors are included in data submitted to Insight as they reflect normal process variation. Summary Selective deletion of control results before QC files are submitted to Insight requires extra work up front. This report should allow the supervisor to detect significant systematic increases in inaccuracy and to monitor performance trends across reports. an out-of-control result must be documented as random error. Document No: WI-2493A Rev. The objective is to submit only control data that reflects analyzer performance. It is not a blind evaluation of point-in-time performance like proficiency testing surveys.Control Data Handling Please Review and Edit Control Data Prior to Submission The Insight Analyzer Report is one type of quality tool. Inclusion ensures the statistically acceptable ranges for inaccuracy do not become too narrow. Each Analyzer Report is intended to reflect on-average analyzer operation. Place a disk into the computer s floppy disk drive. B. weekly or just before submission. USB Memory Stick Save 1. save the control files to floppy disk or to USB Memory Stick. Save QC Files Using the [SysmexInsight] icon. any data points to be deleted must first be documented along with the cause of failure that was identified. Document No: WI-2493A Rev. 13 Page 14 of 20 Effective Date: 1/7/09 . 3. Use SysmexInsight QC files submitted to the Insight program must be saved using the [SysmexInsight] feature. 2.Document Control Data Before Deletion Requirement Whether control data is screened/deleted daily. 3. The icon for Insight is found by pressing [Menu] on the Information Processing Unit (IPU) toolbar. Click [SysmexInsight] icon. Disk Save 1. Click [SysmexInsight] icon. 2. Click [Menu] on the tool bar. A. General Information On Saving QC Files Save Insight QC Files To Disk or To USB Memory Stick XE and XT SERIES ANALYZER 1. Hard Copy Recommended Hard copy documentation is recommended to ensure availability during a laboratory inspection. This documentation is for laboratory records that may have to be available for regulatory inspection. 2. Click [Menu] on the tool bar. Place memory stick in USB port on the analyzer computer. Refer to Operator s Manual for data deletion instructions. A.3. Level. Level. heading. Save all desired Manual files then rename the files with an M at the beginning of the file name. Mode and Lot The left half of the [SysmexInsight] window is labeled Select QD Data. Save all desired Closed files then rename the files with a C at the beginning of the file name. Lot and Instrument ID. Select Control for XT analyzers. When save is finished. Save Files to Disk 1. An hour-glass appears while the Save is being executed. Verify QC Data Info. Analyzer Mode. Rename File Instructions appear below. Move the mouse pointer to the [Save] button and click once. Lot: Select either Current or New as required to obtain the desired e-CHECK lot number for this reporting period. Mode: Click on the [ ] button to pull down list of items and select the appropriate aspiration mode by clicking on Closed or Manual. Select Material. 4. click on the [ ] button next to Level: to pull down list and click on Level 3. Save the Correct Lot The right half of the [SysmexInsight] window displays lot information under the QC Data Info. 5. Document No: WI-2493A Rev. the files need to be renamed to distinguish Closed mode from Manual mode files. Ana. Material: Click on the [ ] button next to Material: to pull down a list of items and select e-CHECK for XE analyzers. Level: Click on the [ ] button next to Level: to pull down a list and click on Level 1. Double click on Floppy A: Saved files appear. and click the [Save] button again. and click the [Save] button again. 4. 2. 3. Located to the right of the Start icon on the analyzer IPU. Go to Floppy Drive to verify files are saved. Verify QC Data Info. click on the [ ] button next to Level: to pull down list and click on Level 2. This area allows selection of a control Material. Make appropriate selections as follows. Save Files to Disk or USB Memory Stick: NOTE: When saving Closed and Manual mode QC files on the same disk or USB Device. Left click on (Show Desktop). When save is finished. Verify that this is the correct lot number of e-CHECK control data for this reporting period. 13 Page 15 of 20 Effective Date: 1/7/09 . Double click on My Computer. Rename one file at a time. For example. 5. 13 Page 16 of 20 Effective Date: 1/7/09 . 7. In the Save In box. may appear. After all desired Closed or Manual files are saved. Rename Files: 1. 3. Located to the right of the Start icon on the analyzer IPU. Rename Files: 1. The name of the removable device. 6. 2. NOTE: If message. Located to the right of the Start icon on the analyzer IPU. Double click on My Computer. Double click on Removable Device Drive. When Please insert disk into Drive A: appears. 3. Switch location depends on manufacturer. for example. When Save is complete.ins 7. flip switch on side of device. 2. Data Traveler (D:). 3. Double click on Removable Device: 4. Double click on My Computer. rename Closed file: QC-730370801. click Cancel. Right click/Choose rename file.ins Document No: WI-2493A Rev. Repeat steps 1-6 to save additional level. Click Save. Verify QC Data Info. rename Manual file: QC-730370801. Located to the right of the Start icon on the analyzer IPU. Left click on (Show Desktop). Rename one file at a time. Double click on Floppy A: 4.ins to CQC-730370801. Click on Removable Disk drive. 5. click on [ ] to choose another level. For example.ins Save Files to USB Memory Stick 1. For example. rename Manual file: QC-730370801. 6. Left click on (Show Desktop). click on the [ ] button to locate Removable Disk Drive. 8. Left click on (Show Desktop). After all desired Closed or Manual files are saved. 7. 2. 6.ins.ins to MQC-730370801. For example. Saved files appear. Right click/Choose rename file. 4. Left click to highlight one file. Go to Removable Drive to verify files are present.ins to MQC-730370801. Double click on My Computer. rename Closed file: QC-730370801. write protected appears. 5.ins to CQC-730370801.B. Move the mouse pointer to the [Save] button and click once. Left click to highlight one file. Go to Floppy Drive to verify files are present. 9. Click [-] Upper right corner to minimize screen. Click menu [F4] on the tool bar. Click QC Files [F5] on the tool bar. Save Insight QC Files To Disk or USB Memory Stick XS-SERIES ANALYZERS 1. flip switch on side of device. 7. 5. Remove Device. USB Memory Stick Save 1. Highlight to choose Lot/Level. Click Insight [F12] on tool bar. Place memory stick in USB port on analyzer. 4. write protected appears. Use SysmexInsight QC files submitted to the Insight Program must be saved using the [SysmexInsight] feature. Click menu [F4] on the tool bar. 2. Click Insight [F12]. Disk Save 1. 6. Click Save. Repeat 3-7 for each lot/level/mode. may appear. 1. Repeat steps 2-6 for each lot/level/mode. 4. 8. 8. Place a disk into the computer s floppy disk drive. Use arrow-down [ ] button in the Save In Box to locate Removable Disk Drive. B. 2.Remove USB Memory Stick Caution: Data may not be saved on device if the stop process is not used. Click Stop USB Mass Storage Device. 2. 7. The name of the device for example. 6. When Please insert disk into Drive A: appears. Double click on Floppy A: Saved files appear. Switch location depends on manufacturer. A. 13 Page 17 of 20 Effective Date: 1/7/09 . Save QC Files Using the [SysmexInsight] feature. Click QC Files [F5]. Document No: WI-2493A Rev. Note: If message. 2. Click on Removable Disk. Click on Removable Device Icon (lower right-hand side of desktop). Data Traveler (D:). 5. Double click on My Computer. 3. save the control files on floppy disk or to USB Memory Stick. 3. Click Save. click Cancel. Highlight to choose Lot/Level. 10. 3. Okay. Click Stop USB Mass Storage Device. Use Insight Icon to Save QC Data. Remove USB Memory Stick Caution: Data may not be saved on device if the stop process is not used. 3. To copy next two control files. Select Cancel.* for this control level and Press [Enter]. At File Name prompt: Enter 8 digit No. Okay. If Okay to Remove does not appear. Level 2 = 0511. QC Chart. Backup. Press [Home] key to return to Main Screen. 6. 7. Press [Enter]. return to step 3. Press [Enter] key to select 1. Double click on My Computer. 4. Click on Removable Device Icon (lower right-hand side of desktop).11. 2. 5. Choose Level/Mode/Los/Save. File Key in the file number for the control level to be copied and press [Enter] key. Place into the DMS computer s disk drive. 8. Go to Removable Drive to verify files are present. Press [F5] key to select QC/CAL. Open Insight icon. Analyzer IPU Select Menu. 3. Click [-] Upper right corner to minimize screen. 13 Page 18 of 20 Effective Date: 1/7/09 . Message appears: Back up QC file data into FD. 4. 9. shut down analyzer before removing the device. Double click on Removable Disk Drive: Saved files appear. 1. 10. Press [Enter] to select [F] QC File Data. 2. Remove Device. 8 digit number consists of the 4 digit lot number plus the control level-specific suffix as follows: SE-CHECK-Level 1 = 0510. Level 3 = 0512 12. Press [B] for B. Message appears: Please insert FD File Name: 11. Press [F1] key to select Sysmex Tools. Save SE-CHECK Insight QC Files To Disk 1. SNCS SAVE AND UPLOAD QC DATA Save QC Data from XE and XT Series Analyzer to Insight Desktop Folder 1. Document No: WI-2493A Rev. Press [1] to select 1. Delete file(s) from folder. Make corrections on analyzer. Please insert disk into Drive A: appears. Problem with uploaded data. Resave data using steps 1 through 3. Make corrections on analyzer. 4. Use arrow down key to save each lot/level. click Cancel. 3. Re-saving same file name with additional data. 4. Select Save To re-save the same file name with additional data. 13 Page 19 of 20 Effective Date: 1/7/09 . Delete file(s) from folder. Use arrow down key in Save in Box to select Desktop Select Insight Data Folder. click overwrite/okay. Repeat steps 1 through 3 to save additional lot/levels. Replace? Yes. Open Insight Data Folder. 2. it is necessary to have two Insight folders or to change the file name when saving. Save in: arrow down to find Desktop. 3. 5. Document No: WI-2493A Rev. Select QC Files F5. Select Insight F12. IF. Re-save data using steps 1 through 3. Save QC to Insight Data Folder. highlight file. Problem with uploaded data. To save both Open/Manual and Closed Modes. Locate Insight Data Folder on Desktop. Save QC Data from XS Series Analyzer to Insight Desktop Folder 1. Use Insight Icon to Save QC Data.2. Highlight to choose lot/level. Save. Analyzer IPU Select Menu F4. Save QC to Insight Data Folder. 10. A lot-to-date report is immediately available. Password: Enter Insight password. 2. serial number mode. 0802 (level 2). The chosen file will appear in the box before the Browse button. Select arrow down key in the Look in box. The QC files for e-CHECK (XS) have the lot number followed by 0804 (level 1). Only One QC File Can Be Uploaded At A Time. and 0812 (level 3). Facility name and primary contact appear. Close the report window by clicking the X in the upper right-hand corner. Click Delete next to the level to be deleted. lot. The QC files for e-CHECK (XE) have the lot number followed by 0810 (level 1). and 0803 (level 3). Do not change. 8. Locate Insight Data folder(s) on desktop. analyzer series. Open Sysmex Insight Icon on IPU Desktop. 0811 (level 2). Select Desktop. 6. Log out. Insight log-on page appears. 7. 9. it may be deleted at this time. Click Yes. 14. The QC files for e-CHECK have the lot number followed by 0801 (level 1). 11. 13 Page 20 of 20 Effective Date: 1/7/09 . 0805 (level 2) and 0806 (level 3). The QC files for plt-CHECK have the lot number followed by 0660 (level1) and 0661 (level 2). 13. 10. The previous screen returns. Shift Default All. Only analyzers your facility enrolled in the Insight program appear. Click one of the three QC files. If batch is incorrect.Upload QC Data from Analyzer Desktop to Insight 1. and 12. Repeat steps 9. Click on arrow key by Analyzer to choose correct analyzer. control. Uploaded time. Collecting Open/Manual and Closed Mode QC files requires two (2) Insight data folders. 5. level. Click Submit. 4. Select Submit QC. Repeat process to delete additional levels. Locate Sysmex Insight Icon and Insight Data Folder(s) on Desktop. Username: Insight customer four-digit number. 11. Click Browse. Click Open. Document No: WI-2493A Rev. Select Data Disk Upload Choose correct instrument. and shift appear. Select type of data to be uploaded. 12. Insert Disk into disk drive or USB Memory Stick into USB Port. Click Submit More Files to submit more levels. Click on Review Report to view submitted data. 3. (Insight Data Manual and Insight Date Closed).