CHEM-0045 Siemens Dimension EXL and Vista Operating Procedure (Bon Secours Mercy Health) PDF

Bon Secours Mercy Health Richmond HealthPartners Laboratories Title: Siemens Dimension EXL and Vista Operating Procedure Number: CHEM-0045 Revision: 3.1 Approval Date: 3/6/2024 Approved By: CoraGabriela UramTuculescu Laboratory Director (URAM0000)...

Bon Secours Mercy Health Richmond HealthPartners Laboratories Title: Siemens Dimension EXL and Vista Operating Procedure Number: CHEM-0045 Revision: 3.1 Approval Date: 3/6/2024 Approved By: CoraGabriela UramTuculescu Laboratory Director (URAM0000) Review Date: 11/11/2024 Reviewed By: Thuy Sandy Minakowski Education Coordinator (101706) CHEM-0045 Siemens Dimension EXL and Vista Operating Procedure Copy of version 3.1 (approved and current) Last Approval or Uncontrolled Copy printed on 12/10/2024 12:49 11/11/2024 Periodic Review Completed PM Next Periodic Review Leetta Bateman Lead MLS 11/11/2025 Printed By Needed On or Before (lcbatema) Effective Date 1/4/2024 Organization Richmond Market Approval and Periodic Review Signatures y p M co12:49 Type Description Date Version Performed By Notes P Periodic Periodic 11/11/2024 3.1 review Review d e 24 Thuy Sandy Minakowski Education Coordinator (101706) New Lab l l 0 Approval Director Approval 3/6/2024 3.1 t r 12/1o 0/ 2 CoraGabriela UramTuculescu Laboratory Director (URAM0000) Owner o on f Approval Approval 1/4/2024 3.1 c ta n rren s Thuy Sandy Pham Education Coordinator (101706) Approval Approval Lab Director Laboratory Director 12/18/2023 12/7/2023 3.0 3.0 U Cu Clifton Bridges Laboratory Director SMH RGH (CLBRIDGE) Mark Williams Laboratory Director (WILL1050) SMC SVMC New Lab Approval Director 12/7/2023 3.0 Mark Williams Laboratory Director (WILL1050) Approval Laboratory Approval Director 10/17/2023 3.0 Jeffery Green MD (JTGREEN) SFMC WEC Laboratory Approval Director 10/13/2023 3.0 Iris Martin Laboratory Director (MART0216) RCH Laboratory Approval Director 10/9/2023 3.0 Lindsey Matthews Laboratory Director (MATT0083) CEC Laboratory Approval Director 10/6/2023 3.0 Jack Wilson Laboratory Director (JJWILSON) SPEC  Laboratory Approval Director 10/3/2023 3.0 MRMC CoraGabriela UramTuculescu Laboratory Director (URAM0000) Laboratory Approval Director 10/3/2023 3.0 SECC Angie DUONG Laboratory Director (ADUONG) Owner Approval 10/3/2023 3.0 Approval Thuy Sandy Pham Education Coordinator (101706) Periodic Designated 7/19/2023 2.0 Thuy Sandy Pham Education Coordinator (101706) review Reviewer y p M Recorded on 6/29/2023 by Thuy Sandy Minakowski Periodic review Captured Designated Reviewer 10/12/2022 2.0 Crystal Morden o c :4 9 P Education Coordinator (101706) when document d outside added to Document MediaLab 12 Control (previous l le 24 0 system of record: Master Control Document Records) t r 12/1 o 0/ 2 Recorded on 6/29/2023 by Thuy n f Sandy Minakowski Education Approval Captured outside MediaLab Lab Director 7/20/2015 2.0 o o Clifton Bridges Laboratory Director (CLBRIDGE) c ta s Coordinator (101706) when document added to Document n rren Control (previous system of record: U Cu Approvals and periodic reviews that occurred before this document was added to Document Control may not be listed. Master Control Document Records) Version History Version Status Type Date Added Date Effective Date Retired 3.1 Approved and Current Minor revision 1/2/2024 1/4/2024 Indefinite 3.0 Retired Major revision 9/27/2023 12/18/2023 1/4/2024 2.0 Retired First version in Document Control 6/29/2023 10/6/2021 12/18/2023  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 CLINICAL SIGNIFICANCE Dimension Chemistry Systems perform clinical tests on serum, plasma, fluid, and urine specimens. Dimension Vista and EXL provide results for a wide array of chemical analytes used in routine chemistry profiles, drug assays, cardiac markers, and immunoassays. PRINCIPLE The methods used for testing on the Dimension analyzers include end point, rate, LOCI and turbidimetric methodologies utilizing wet chemistry/FLEX cartridges. Instrument includes integrated multi-sensor (IMT) technology for electrolytes. The heterogeneous immunoassay module (HM) is used to process chromium-based immunoassays. y p M SPECIMEN REQUIREMENTS Plasma Lactate requires sodium fluoride (gray top) on ice. o c :4 9 P d 12 Ammonia requires lithium heparin plasma (green top with or without gel) on ice. e 24 serum SST tubes. l l Therapeutic drug levels require red top tubes, although some drugs can be performed in 0 t r 12/1o 0/ 2 Most Emergency Department (ED) and in-patient samples will be collected in plasma separator tubes. SST tubes will be accepted for most assays; exceptions include NH3, Lactate, Salicylate, and certain TDMs. o n f See chart and Siemens’ Information for Use (IFU) for assay specific information. o Patient Preparation c ta n rren s U Cu Most assays do not need special patient preparation. For Alcohol, do not cleanse the draw site with alcohol or other volatile disinfectants. Specimen Types: Serum, Plasma, Urine (see Urine Chemistry Procedure), Body Fluids and CSF (see Body Fluid Procedure). Sample Stability: See HealthPartners Laboratory (HPL) Online Test Menu or Siemens IFU for details on specimen stability and handling. Unacceptable Specimens All samples must be checked for complete clotting before analysis. o Loading samples with fibrin will cause erroneous results and lead to clogged sample and IMT probes. See IFU or package insert and the HPL Directory of Laboratory Services for details on unacceptable samples. Page 1 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 1 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 Dimensions have been set to flag Hemolysis, Icteric, and Lipemic results on affected assays. See section on HIL for more detailed information. Refer to the Specimen Integrity procedure in General Laboratory Policy Manual or the specific Siemens Operators Manuals and the specific assay for complete overview of acceptable process. EQUIPMENT AND MATERIALS Equipment: Siemens Dimension EXL Siemens Dimension Vista 500/1500 Materials: FLEX cartridges Reaction Vessels y p M Sample Cups Small sample containers (SSC) Transfer pipettes Reagent Probe Cleaner Sample Probe Cleaner Dilution Check o c :4 9 P 1ml fixed automatic pipette d 12 Std A, Std B, flush solution e 24 EXL: Vista: l l 0 CHK FLEX for daily System Checks Cuvette film o Cuvette Wash t r 12/1 System Diluent 0/ 2 Chemistry Wash Salt bridge solution o n f V-Lyte Mulitsensor Aliquot Plates o QuikLYTE sample diluents QuikLYTE Sensor IMT Probe Cleaner c ta n rren sCuvettes Aliquot Segments U Cu Reagent Preparation Instruments with Reagent Management Systems will hydrate assays that are needed for testing as scheduled. Tests can be hydrated on demand using the Reagent Hydration Screen, see Operator’s Guide for further detail. See separate procedure for reagent that must be prepared, i.e., β-Hydroxybutyrate. Storage Requirements: Store Reagent Flex cartridges at 2-8° C; follow manufacturer’s instructions for storage exactly. All Dimension analyzers will maintain an open date and expiration date for each well and Reagent Flex. The system will automatically move to a new well or new Reagent Flex when needed and discard any expired reagent. Page 2 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 2 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 CALIBRATION Refer to separate Calibration procedure for EXL and Vista. QUALITY CONTROL The first step in quality control on the Dimension is the System Check on the EXL and the Probe Test on the Vista. 1. The System Check and Probe Test results must be documented in Unity as a part of daily quality control (QC). o If this procedure must be skipped, place comment in Unity stating reason for not performing. This should not be a common occurrence. o Refer to the Siemens instrument-specific Operators Guide for System Check and y p M Probe Test performance procedures. 2. Temperatures are checked on each analyzer daily and entered into Unity. o c :4 9 P QC Frequency d e 24 12 l l At least 2 levels of controls for each analyte must be run once every 24 hours. 0 o EXL: controls will be run on all reagent lots on board. t r 12/1o 0/ 2 o Vista: reagent lots “in use” will be the only lot processed during automatically scheduled QC. If other lot is onboard, quality control will be performed on the Vista prior to placing reagent lot “in use.” Post calibration of a test o on f c ta Post new lot of reagent placement on the instrument n rren s Post Maintenance or Maintenance affecting instrument server, including replacement U Cu and/or realignment of probes affecting instrument server. o For example: Vista 1500 has 3 servers. If maintenance is performed and only affects server 3, then QC must be performed for those analytes on server 3. Both the EXL and Vista have a hard stop in place if QC has not been performed for any given analytes within 24 hours. QC must: Be run in the same manner as a patient sample. Be reviewed in Unity and found acceptable before resuming patient testing. o Review data for outliers, shifts, or trends. Have documentation of corrective action taken in Unity when found unacceptable. QC Preparation See HPL QC Handling Procedure for controls, handling conditions and use. Follow manufacturer’s instructions exactly. Page 3 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 3 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 Batched Mode or Open/Close QC Performed just prior to the first sample and just after the last sample in the batch. Major PMs: QC to be performed prior to PM being performed and after PM is completed. QC must be acceptable before performing PM, troubleshoot any outliers. Crossing/moving into a new lot of QC. Low volume assays not performed daily, i.e., Free PTN. Both QC sets are required to be acceptable to accept the run and report patient values. Other considerations may require QC to be performed in batched mode. EXL Manual QC Procedure – Stepwise See Operator’s Guide for further detail. y p M 1. From the Operating Menu press F1: Enter Date o c :4 2. Type the letter and number of an available segment position (ex. A1) > press Enter. 9 P d 3. Type QC then name of control (ex. QCMQ1) in Patient Name Field > press Enter. e 24 12 4. Message will appear “data for this QC exists do you want use it” > press “Y” and all the tests pre-programmed. l l 0 o 0/ 2 5. If QC was not pre-programmed at the Sample No., type C-QC NAME (ex. C-MQ1) > press t r 12/1 ENTER, until cursor is on TESTS. From keyboard, select tests to be run on the control. Each site has created QC panels. o 6. Press F4: Next Priority until priority states QC. on f c ta s 7. Press F8: Next Fluid until states SERUM QC1 or 2 or 3. Select appropriate QC type, serum, urine, or CSF QC fluid type. n rren U Cu 8. Press F1: New Sample and the segment field automatically displays the next available position. 9. Repeat steps 3-4 if QC is pre-programmed or steps 3-8 if need to program QC. 10. Press F3: Loadlist and load QC samples into their assigned positions. 11. Place segment on the instrument. 12. Press either the F4: Run key from Load list screen or the Run key on the keyboard or touch screen 13. QC must be reviewed using HPL QC Check Off sheet to ensure all levels of expected controls are reviewed in Unity with appropriate documentation. EXL Barcoded QC Procedure - Stepwise See Operator’s Guide for further details. 1. Ensure that no pending samples remain on the Load List for the segments you intend to use by pressing Alt L (press F2: Next Status until you see ALL SAMPLES). Page 4 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 4 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 2. Load barcoded tubes into orange/yellow racks only with labels facing out. 3. Insert short sample cups (SSC) into the barcoded tubes and fill with correct control material to appropriate level. 4. Place segment(s) onto the instrument and press Run. 5. QC must be reviewed using HPL QC Check Off sheet to ensure all levels of expected controls are reviewed in Unity with appropriate documentation. VISTA QC Procedure – Stepwise See Operator’s Guide for further detail. 1. Load QC vials with QC barcode visible. To print QC barcodes: y p M a. Advanced > QC Order Screen or System > Method Summary > QC 2. If programmed, Vista will automatically run controls every 24 hours. 3. Order and Run/Rerun QC, one of two ways: o c :4 9 P a. Advanced > QC > QC Order d e 24 12 b. Select Run QC Panel or Run Single Method l l 0 c. Select Panel or Single Test d. Select Level(s) t r 12/1o 0/ 2 o n f e. Select QC Source: Vial or Cup (Vial is default) f. Select Lot Type: Active or Parallel (if applicable) o g. Submit OR c ta n rren s U Cu a. System > Method Summary > QC h. Select Method from sidebar i. Select the Lot number (if more than one) from the drop-down box j. Select the level of QC k. Press Rerun QC Vista QC Notes On Board vials must be filled using automatic pipette to ensure adequate volume is present for system. When QC is requested, Vista will aspirate a minimum of 200 μL of control. Check volume remaining in control vials before running QC. Vista will alert the user when QC is depleted, and more is required on the instrument. Never “top off” QC already onboard. Page 5 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 5 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 QC must be reviewed using HPL QC Check Off sheet to ensure all levels of expected controls are reviewed in Unity with appropriate documentation. Troubleshooting Unacceptable QC 1. Select test(s) to be repeated. When result is reviewed, the acceptable Unity action code on repeat will be “Reran with same vial of control on board Vista.” 2. If QC is still unacceptable, remove vial from Vista. Inspect vial cap for proper piercing. If cap is damaged, call for service. 3. Check volume of control in vial. If control level is too low, discard vial and replace with new vial filled from same bottle of control. Never “top off” QC already on board with new material. y p M o c :4 4. Repeat test(s). Action code for result will be “Repeated with new vial on board Vista, control is from same bottle of QC”. 9 P d 12 5. If QC is still unacceptable, discard vial again and open new bottle of control. Fill control e 24 l l in vial using new bottle of QC. When results are reviewed, add action code “New vial on 0 board Vista from new bottle of control.” t r 12/1o 0/ 2 Reviewing QC Results for EXL and Vista o If controls are not acceptable, follow this plan of action: on f c ta 1. Check LJ charts and look for trends or shifts. n rren s 2. Check recent activities and take appropriate remedial action as required. U Cu a. Were any other anayltes affected? b. Was the assay calibrated recently? c. Is this a new lot a reagent? d. Has the instrument recently been service or had a PM performed? 3. Probe replacement without alignment can cause QC failures. a. Sudden shifts may indicate control needs to be replaced. Analyze a fresh vial of control material. If a new FLEX was loaded, reagent stability may be the problem. Replace FLEX cartridge or move to next reagent well in flex. If you move to a new well or FLEX cartridge all levels of QC must be repeated. Downward or upward trends may indicate deteriorating control or reagent as well. Replace as above. If still unacceptable, trend may signal need to recalibrate. If calibration does not resolve issue, call Siemens Technical Center. Failures that involve multiple tests indicate a systemic problem, probably with the instrument or with the wrong control material. Confirm correct control was used. Call Siemens Technical for multiple test failures. Page 6 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 6 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 QC Note: For more specific reviewing criteria see the QC Handling and Review Procedure and HPL Chemistry QC PLAN. If upon review it is discovered that any level of QC is outside 3SD or more, a Lookback may need to be performed. Refer to the Lookback Procedure for next steps. The Lookback form can be found in the Forms vault in MediaLab. MAINTENANCE Refer to EXL/Vista Operator’s Guide for details regarding Daily, Weekly, Monthly, and As Needed Maintenance. All maintenance is entered into QCE by the performing tech and is reviewed weekly and y p M monthly by the department supervisor and/or QA department for compliance and outliers. o c :4 9 P QCE sheets can be found in the QCE folder on the Shared Drive (site may print and insert a copy if desired). d e 24 12 CAP SURVEYS AND INTERLABS l l 0 t r 12/1o 0/ 2 CAP surveys are rotated throughout all three shifts and staffing. See HPL Chemistry QC Plan, o n f HPL CAP Survey Procedure and HPL General Laboratory Policy Manual for additional CAP information. Interlabs are also performed per HPL policy where appropriate. o TESTING PROCEDURE – STEPWISE n c ta n rre s U Cu Processing Specimens on Dimension EXL and Vista 1. Centrifuge all specimens according to manufacturer’s instruction. 2. Check specimens for fibrin clots and sufficient volume. Refer to the ‘tube fill gauge’ for sufficient sample volume. 3. Refer to EXL/Vista Operator’s Guide for processing/loading the following sample types: a. Properly filled barcoded tubes b. Properly filled non-barcoded tubes c. Short or Aliquoted samples that require the use of a Sample Cup or SSC Note: Failure to load samples correctly can lead to probes crashes and/or erroneously results. REPORTING RESULTS Reference Ranges: See Global Test Parameters on HPL Shared Drive for complete current listing of HPL Reference Ranges and LIS. Page 7 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 7 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 Delta failures: See HPL Procedure Reviewing Delta Failure Results. Critical Values See HPL approved critical value list on intranet. Chemistry instruments are set to auto-repeat most critical values with exceptions: A chemistry sample that is loaded onto the instrument in a limited sample rack. Lactic Acids and Elevated Troponins (Courtesy Call) are not repeated due to length of test time. Resulting in the LIS Function: OEM or OEA Tech: Enter y p M Shift: Enter Device: o c :4 9 P Site MRMC Device MV3 or MV4 d e 24 12 RCH l l CEXL3 or CEXL4 0 RGH SFMC SFWEC t r 12/1o REXL1 or REXL2 FV1 or FV2 FWEXL 0/ 2 SMH SPEC o on f SV3 or SV4 SPEXL SRMC SECC c ta n rren s RREXL1 or RREXL2 RHEXL Test: Enter Workload Data: Enter U Cu SVRMC REEXL1 or REEXL2 Start at Cup: Press Enter to advance to next cup or type in desired cup number. LIS will display patient information and results, then choose one of the following: o A (accept), D (display prior), M (modify), R (reject) Function: MEM Tech: ENTER Shift: ENTER to default or enter shift number Worksheet: Site Worksheet MRMC EKTA RCH CCHEM RGH RCHEM Page 8 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 8 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 Site Worksheet SFMC FCHEM SFWEC FWCHEM SMH SCHEM, TR4, STR5 and TR5 SPEC SPCHEM SRMC RRCHEM SECC RHCHEM SVRMC RECHEM Enter through TEST or the test(s) can be entered at the prompt o Note: The correct instrument MUST be associated with the test result when entered in MEM Type in accession number and enter results then choose one of the following: y p M o A (accept), D (display prior), M (modify), R (reject) o c :4 9 P Reportable Range d e 24 12 See EXL and Vista tables below for Analytic Measurement Range (AMR) and Clinical Reportable Range (CRR). l l 0 t dilution will not occur in the following circumstances: r 12/1o 0/ 2 Siemens instruments are set to auto-dilute according to the approved protocol. Auto- o Auto dilution is not selected for the assay o Onboard sample volume is inadequate o on f o A short sample rack is used c ta n rren s Note: Siemens auto-dilutions are performed by reducing sample volume Any result that appears as ‘Above Assay Range’ must have the result entered manually. U Cu o Enter a number above the stated CRR and allow the LIS to automatically default to ‘>’. Any result that appears as ‘Below Assay Range’ must have the result entered manually. o Enter a number below the stated CRR and allow the LIS to automatically default to ‘’ must be re-entered to ensure the current CRR is being reported. Re-entering the result allows the LIS to automatically default the correct CRR. Example: If an hsCRP appears as >190, re-enter the result as 190, the LIS will automatically default the result as >9.5. Physician Request for Results that Exceed the Clinical Reportable Range Laboratory director may approve individual requests for sample testing that exceeds stated CRR. Manually dilute the sample to endpoint. Result will need to be entered as a free text. Additionally, add a comment stating, “approved by Dr.____ on (date).” Page 9 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 9 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 HIL Flags Any sample flagged with Siemens Hemolysis, Lipemia, and/or Icterus (HIL) message must be visually inspected by tech. Samples with lipemia or icterus may need to be diluted. See section on Dilutions. Special Message will be triggered in LIS for HIL failures: HIL (Hemoglobin, Bilirubin, and Lipemia) is a system used to detect these interferents. If hemolysis, icterus, or lipemia are detected the instrument will flag the results for a Technologist to review. The EXL has a HIL system that grades with a number 1-6 which corresponds to an approximate concentration range for the interferents. The Vista has a HIL system that grades with a number 1-8 which corresponds to an approximate concentration range for the interferents. y p M assay. o Each instrument type will follow the manufacturer’s recommended HIL settings for each c :4 9 P d 12 Follow HPL HIL policy for resolving hemolyzed, icteric, and lipemic samples. See Flowchart at the end of procedure. e 24 l l 0 Test [H] Value [I] Value [L] Value tr o HIL Thresholds for the EXL Test 2 / 0/ 2 1 [H] Value [I] Value [L] Value ACTMN ALB 0 0 3 0 o 6 5nso HCG K f1 0 2 6 0 0 6 ALPI ALTI AMM 6 0 3 6 6 5 c ta n rren 4 4 4 LA LDI MG 0 2 4 4 6 5 6 6 6 AMY AST 6 3 0 4 U Cu 6 4 MMB NA 0 6 0 0 0 6 BUN 0 0 4 NTP 0 6 0 CA 0 6 4 PBNP 0 6 0 CKI 3 0 0 PHENO 0 0 4 CL 6 0 6 PHOS 3 3 4 CREA 0 5 4 PTN 0 0 5 CRP 0 0 5 SAL 0 3 4 CTNI 0 4 0 TBI 0 0 4 DBI 2 0 3 THEO 0 0 6 DGNA 0 0 6 TNI 6 5 0 ECO2 6 0 6 TP 5 3 4 ETOH 0 0 0 TSHL 6 5 0 GLUC 5 4 3 URICA 0 0 4 Page 10 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 10 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 HIL Threshold for the Vista 500/1500 Test H Value I Value L value Test H Value I Value L value ACTMN 2 HDLC 8 ALTi 7 4 IRON 3 AMM 7 7 8 K 3 AMY 7 8 LA 7 7 AST 3 7 4 LDH 3 7 BOHB LDLC 7 8 BUN 8 MG 3 CA 5 MMB 7 CHOL CK 7 3 8 8 PBNP PHNO 7 7 y p M CRBAM CREA 4 8 PHOS PTN 7 o c :4 9 P 7 5 8 CTNI DBIL 7 4 8 SAL T4 d e 24 12 2 7 8 DIG 7 6 TBIL l l 204 7 FT3 FT4 GENT 7 6 6 8 t THEO r 12/1 TIBC TP o 0 / 6 8 7 8 GGT GLU 7 o 8 3 on f TRIG TSH 7 3 8 8 c ta n rren s U Cu Page 11 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 11 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 EXL 200 Test Menu Analytical Standard Auto dilute Auto Diluent for HPL Clinical Specimen Test Measurement Volume Sample Dilution Manual Reportable Type Range (AMR) (μL) Volume Factor Dilutions Range (CRR) Dilute Drug Free 2.0-600 ACTMN Serum 0-300 μg/mL 4 2.0 Manually Patient μg/mL Reagent Serum 0.6-20.0 ALB 0.6-8.0 g/dL 5 2 2.5 Grade Plasma g/dL Water Serum 10-1000 Enzyme 10-2300 ALPI 7 3 2.3 Plasma U/L Diluent U/L ALTI Serum Plasma 6-1000 U/L 35 10 3.5 y p M Enzyme Diluent 6-3500 U/L AMM LI Heparin Plasma on ice 10-750 μmol/L 44 22 2.0o c :4 9 P Reagent Grade Water 10-1500 μmol/L AMY Serum Plasma 0-650 U/L 14 7 d e 24 12 2.0 Enzyme Diluent 2-1300 U/L AST Serum 0-1000 40 20l l 02 Enzyme 3-2000 U/L, repeat BOHB Plasma See BOHB U/L tr o 2/ 10 /2 Diluent values 18 to 80 mg/dL Page 12 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 12 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 Analytical Standard Auto dilute Auto Diluent for HPL Clinical Specimen Test Measurement Volume Sample Dilution Manual Reportable Type Range (AMR) (μL) Volume Factor Dilutions Range (CRR) Reagent Serum 0.1-16.0 0.1-38.0 DBI 10 5 2.0 Grade Plasma mg/dL mg/dL Water Drug free 0.20-5.00 Dilute 0.2-10.0 DGNA Serum 30 Patient ng/mL Manually ng/mL Sample Serum 5-45 5-45 ECO2 5 None None None Plasma mmol/L mmol/L ETOH Serum Plasma 3-300 mg/dL 9 3 3 y p M Reagent Grade Water 10-900 mg/dL 20o c :4 (Manual 9 P Sample Diluent (Manual FERR Serum Plasma 1-1000 ng/mL 40 2 d e 24 12 dilution required dilution Sample 1-40000 ng/mL l l for values 0 >20000, Diluent of Serum t r 12/1o 0/ 2 see IFU ) level 1 Ferr Cal, see IFU) Reagent GLUC Plasma CSF 0-500 mg/dL 3 o on f 2 1.5 Grade Water 1-1500 mg/dL HCG Serum Plasma Serum 1-1000 mIU/mL 3-150 c ta 40 n rren s 2 20 Sample Diluent Reagent 1-200,000 mIU/ml 3-600 HDLC Plasma Serum mg/dL U Cu 3 2 1.5 Grade Water Reagent mg/dL 5-2000 IRN 5-1000 µg/dL 40 20 5.0 Grade Plasma µg/dL Water Serum 1.0-10.0 1.0-10.0 K 40 None None None Plasma mmol/L mmol/L Sodium Reagent Fluoride 0.3-15 0.3-30.0 LA 4 2 2 Grade plasma on mmol/L mmol/L Water ice Serum 6-1000 Enzyme 6-4000 LDI 8 2 4 Plasma U/L Diluent U/L 1.5 Serum 6-250 Enzyme 6-5000 LIP 3 2 (manually Plasma U/L Diluent U/L dilute x20) Drug Free 0.2-5.0 Dilute 0.2-endpoint LITH Serum 20 2 Patient mmol/L Manually mmol/L Sample Page 13 of 27 Uncontrolled copy printed by Leetta Bateman Lead MLS on 12/10/2024 12:49 PM (EST). Page 13 of 27  Bon Secours Mercy Health Richmond HealthPartners Laboratories Siemens Dimension EXL and Vista Operating Procedure CHEM-0045 (Version 3.1) Approved and current. Effective starting 1/4/2024. Bon Secours HealthPartners Laboratories Richmond, Virginia Technical Section: Chemistry Procedure: Operating the Dimension EXL 200 and Vista 500/1500 Analytical Standard Auto dilute Auto Diluent for HPL Clinical Specimen Test Measurement Volume Sample Dilution Manual Reportable Type Range (AMR) (μL) Volume Factor Dilutions Range (CRR) Reagent Serum 0.0-20.0 0.3-20.0 MG 4 None None Grade Plasma mg/dL mg/dL Water Serum 0.5-300 Sample 1.0-600.0 MMB 60 30 2 Plasma ng/mL Diluent ng/mL Serum 50-200 50-200 NA 40 None None None Plasma mmol/L mmol/L Serum 5-35000 Sample 5-35000 PBNP 50 None None PHENO Plasma Serum pg/mL 2.1-80 4 2 2 y p M Diluent Reagent Grade pg/mL 2.1-320.0 PHOS Serum μg/mL 0.5-9.0 3 2 1.5 o c :4 9 P Water Reagent Grade μg/mL 0.5-13.5 Plasma mg/dL d e 24 12 Water mg/dL ll Drug Free 0.5-40.0 0.5-80.0 PTN Serum 4 2 2 Patient μg/mL 0 μg/mL SAL Serum 0.2-100.0 15 o tr 2/1 5 0 / 2 3 Sample Reagent Grade 1.7-endpoint Serum mg/dL 0.1-25.0 n o so f 1 Water Reagent mg/dL 0.1-50.0 TBI Plasma mg/dL 2.0-40.0 n c 10 n t a 5 2 Grade Water Reagent mg/dL