Dimension EXL and Vista Operating Procedure
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Questions and Answers

What should be done if a new FLEX is loaded and there is a stability issue?

  • Call Siemens Technical Center immediately.
  • Ignore the problem as it will resolve itself.
  • Replace the FLEX cartridge or move to the next reagent well. (correct)
  • Run the assay without any changes.

What must be repeated if the FLEX cartridge is replaced?

  • Calibration for the new reagents.
  • All levels of QC. (correct)
  • Only the control materials.
  • The entire assay.

Which of the following trends may indicate a need to recalibrate the instrument?

  • Consistent results with no variation.
  • Intermittent failures with time gaps.
  • Downward or upward trends indicating poor control. (correct)
  • Stable control materials with high readings.

What should be done if multiple test failures occur?

<p>Confirm correct control was used and call Siemens Technical Center. (A)</p> Signup and view all the answers

When should a Lookback be performed according to the QC note?

<p>If any level of QC is outside 3SD or more. (B)</p> Signup and view all the answers

What is indicated by repeated upward or downward trends in control results?

<p>There may be a need to replace reagents or recalibrate. (D)</p> Signup and view all the answers

What is suggested if calibration does not resolve an issue with the instrument?

<p>Call Siemens Technical Center for additional support. (D)</p> Signup and view all the answers

Which document should be referred to for specific reviewing criteria in QC handling?

<p>QC Handling and Review Procedure. (D)</p> Signup and view all the answers

What is the version status of the Dimension Chemistry Systems procedure as of January 4, 2024?

<p>Approved and Current (B)</p> Signup and view all the answers

Which of the following methods is NOT used for testing on the Dimension analyzers?

<p>Immunofluorescence (C)</p> Signup and view all the answers

Which version of the Document Control is indicated as the first version?

<p>Version 2.0 (D)</p> Signup and view all the answers

What is the clinical significance of the Dimension Chemistry Systems?

<p>They perform clinical tests on serum, plasma, fluid, and urine specimens. (C)</p> Signup and view all the answers

What technology does the instrument use for electrolytes?

<p>Integrated multi-sensor (IMT) technology (D)</p> Signup and view all the answers

What is the specimen requirement for Plasma Lactate?

<p>It requires sodium fluoride and should be kept on ice. (D)</p> Signup and view all the answers

When was version 3.0 of the Document Control retired?

<p>December 18, 2023 (D)</p> Signup and view all the answers

Which of the following statements about the Dimension Vista and EXL is correct?

<p>They provide results for a wide array of chemical analytes. (B)</p> Signup and view all the answers

What does the 'HIL Thresholds for the EXL' indicate?

<p>Normal ranges for various lab tests. (C)</p> Signup and view all the answers

Which test has a [H] Value of 0?

<p>CKI (B)</p> Signup and view all the answers

Which of the following has the highest [L] Value?

<p>DGNA (D)</p> Signup and view all the answers

What is the [I] Value for the test AMY?

<p>3 (C)</p> Signup and view all the answers

What value indicates a critical result for the test PHOS?

<p>4 (B)</p> Signup and view all the answers

Which substance has a [H] Value of 6 and [L] Value of 6?

<p>ECO2 (D)</p> Signup and view all the answers

How many tests have a [H] Value of 0?

<p>6 (A)</p> Signup and view all the answers

Which of the following tests does not have a listed [I] Value?

<p>PHENO (C)</p> Signup and view all the answers

Which test has the lowest [I] Value?

<p>BUN (C)</p> Signup and view all the answers

For which test is the [I] Value the highest?

<p>HCG (C)</p> Signup and view all the answers

What does a [I] Value of 5 represent for the test TP?

<p>Elevated level (D)</p> Signup and view all the answers

Which of the following tests has an [L] Value of 0?

<p>PHENO (B)</p> Signup and view all the answers

What does an HIL Threshold indicate for patient test interpretation?

<p>They identify test-specific ranges. (D)</p> Signup and view all the answers

What is the analytical measurement range (AMR) for ETOH in serum?

<p>3-300 mg/dL (D)</p> Signup and view all the answers

Which type of specimen requires a manual dilution for the GLUC test?

<p>Serum (A)</p> Signup and view all the answers

What is the diluent used for the ETOH test?

<p>Drug free water (B)</p> Signup and view all the answers

Which test has a reportable range of 0.1-38.0?

<p>DBI (A)</p> Signup and view all the answers

What is the sample volume required for the HCG test?

<p>3 μL (C)</p> Signup and view all the answers

What criteria defines the reportable range for the HCG test?

<p>1-200,000 mIU/mL (A)</p> Signup and view all the answers

For which test is no dilution method needed?

<p>ECO2 (D)</p> Signup and view all the answers

What is the manual dilution factor for serum in the DGNA test?

<p>2 (B)</p> Signup and view all the answers

Which test has a specimen type requiring no dilution method?

<p>K (C)</p> Signup and view all the answers

What is the auto dilution factor for ETOH in plasma?

<p>3 (A)</p> Signup and view all the answers

What is the analytical measurement range (AMR) for the FERR test in serum?

<p>1-1000 ng/mL (C)</p> Signup and view all the answers

What is the reportable range for LIP test in serum?

<p>6-250 U/L (D)</p> Signup and view all the answers

What is the diluent for the LITH test?

<p>Patient Sample (D)</p> Signup and view all the answers

What is the approval date of the document titled 'Siemens Dimension EXL and Vista Operating Procedure'?

<p>3/6/2024 (A)</p> Signup and view all the answers

Who is the Laboratory Director that approved the document?

<p>CoraGabriela UramTuculescu (A)</p> Signup and view all the answers

What is the effective date of the Siemens Dimension EXL and Vista Operating Procedure?

<p>1/4/2024 (D)</p> Signup and view all the answers

When is the next periodic review scheduled for the document?

<p>11/11/2025 (C)</p> Signup and view all the answers

Which revision number is the current version of the document?

<p>3.1 (D)</p> Signup and view all the answers

Who performed the periodic review on 11/11/2024?

<p>Thuy Sandy Minakowski (A)</p> Signup and view all the answers

Which designation is listed as the lead for the periodic review needed by 11/11/2025?

<p>Leetta Bateman (D)</p> Signup and view all the answers

What type of document is 'CHEM-0045' categorized as?

<p>Operating Procedure (B)</p> Signup and view all the answers

What is the role of Thuy Sandy Pham as indicated in the document?

<p>Education Coordinator (A)</p> Signup and view all the answers

When was the last periodic review documented?

<p>7/19/2023 (D)</p> Signup and view all the answers

What is the role of CoraGabriela UramTuculescu in the document?

<p>Laboratory Director (B)</p> Signup and view all the answers

Who recorded the document on 6/29/2023?

<p>Thuy Sandy Minakowski (D)</p> Signup and view all the answers

What is the primary subject of the document CHEM-0045?

<p>Siemens Equipment Operation (D)</p> Signup and view all the answers

Which option is NOT a designation of the individuals listed for approvals?

<p>Scientific Director (D)</p> Signup and view all the answers

What is the analytical measurement range for ACTMN when using serum?

<p>0-300 μg/mL (B)</p> Signup and view all the answers

What is the required specimen volume for ALB testing?

<p>5 μL (D)</p> Signup and view all the answers

What is the auto dilution factor for ALPI?

<p>2.3 (D)</p> Signup and view all the answers

For which specimen type is the AMM test performed?

<p>Plasma on ice (A)</p> Signup and view all the answers

Which test has a reportable range of 0.6-20.0 g/dL?

<p>ALB (A)</p> Signup and view all the answers

What is the analytical measurement range for AMY testing using serum?

<p>0-650 U/L (D)</p> Signup and view all the answers

What analytical measurement range corresponds to the ALTI test?

<p>6-1000 U/L (D)</p> Signup and view all the answers

What is the auto dilute sample volume for the AMY test?

<p>7 μL (D)</p> Signup and view all the answers

For AST testing, what is the maximum analytical measurement range?

<p>2000 U/L (B)</p> Signup and view all the answers

What type of specimen is used for ALPI testing?

<p>Plasma (B)</p> Signup and view all the answers

What specimen type is required for the BOHB test?

<p>Plasma (B)</p> Signup and view all the answers

Which test has a manual dilution range of 2.5?

<p>ALB (D)</p> Signup and view all the answers

Which test has a reportable range of 10-1500 μmol/L?

<p>AMM (D)</p> Signup and view all the answers

Flashcards

Version History

A document's version history tracks its changes over time, noting when versions are created, approved, and retired.

Approved and Current Version

The current version of a document, actively used and considered accurate.

Minor Revision

Indicates a minor update or revision to a document.

Major Revision

Indicates a significant update or change to a document.

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Date Effective

The date a document version becomes the official and active one.

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Date Retired

The date a document version is no longer considered valid or used.

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Siemens Dimension EXL and Vista Analyzers

Siemens Dimension EXL and Vista are chemistry analyzers used for clinical testing.

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Dimension Analyzer Methods

The Dimension analyzers use different techniques like end-point, rate, and turbidimetric methods to perform chemical tests.

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FLEX Cartridge Stability Issue

If a new FLEX cartridge is loaded and QC fails, it could indicate a problem with reagent stability. The solution is to replace the FLEX cartridge or move to a new reagent well.

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Repeat QC After FLEX Change

When moving to a new reagent well or FLEX cartridge, all levels of QC must be repeated to ensure accuracy and reliability.

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QC Trend

A downward or upward trend in QC results may indicate deterioration of the control or reagent. The solution is to replace them as described for FLEX cartridge failures. If the issue persists after replacement, recalibration may be necessary. If recalibration fails to resolve the issue, contact Siemens Technical Center.

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Multiple Test Failure

If multiple tests fail QC, it indicates a systemic problem likely related to the instrument or the control material used. Verify the correct control material was used and contact Siemens Technical for further assistance.

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QC Reviewing Criteria

Refer to the QC Handling and Review Procedure and the Chemistry QC PLAN for specific reviewing criteria.

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Lookback Procedure

If QC is outside of 3 SD, a Lookback may be needed to investigate the cause and impact of the out-of-range results. The Lookback form is available in the Forms vault in MediaLab.

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EXL/Vista Maintenance Procedures

Refer to the EXL/Vista Operator’s Guide for details regarding Daily, Weekly, Monthly, and As Needed Maintenance.

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Lookback Form Location

The Lookback form can be found in the Forms vault in MediaLab for documentation and investigation of out-of-range QC results.

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Approved Version

The document's official version, confirmed by a responsible individual.

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Review Date

The date when the document was reviewed and potentially updated.

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Uncontrolled Copy

A document is considered uncontrolled if it is not the latest approved version and should not be used for operational or administrative purposes.

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Periodic Review

A scheduled check to ensure the document remains relevant and up-to-date.

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Document Control

A document is considered controlled when it is the latest approved version and can be safely relied upon for operational and administrative use.

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Approval

A formal process where a document is reviewed and authorized for use by a designated individual.

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Effective Date

The date when the approved document takes effect and becomes the official version.

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Approved By

The individual responsible for approving or reviewing the document.

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Version

The document's version number, indicating the latest update.

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Performed By

Identifies the individual who added the approval or periodic review record.

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Description

A brief explanation of the purpose of the document.

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Notes

Notes or specific details related to the approval or review process.

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Organization

The organization or department for which the document applies.

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Title

The name given to the document (usually includes a subject and number).

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Procedure Number

A unique identifier for the document.

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What is a laboratory test?

A laboratory test that measures the amount of a substance in the blood.

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What do the [H], [I], and [L] values represent?

The [H] Value, [I] Value, and [L] Value represent the High, Intermediate, and Low thresholds for a particular lab result.

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What does a high [H] value mean?

A high threshold (H) value for a lab result indicates a potentially high level of the substance being tested.

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What does a low [L] value mean?

A low threshold (L) value for a lab result indicates a potentially low level of the substance being tested.

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What are the values in the table referring to?

The values shown in the table are the HIL thresholds for various laboratory test results.

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What does "ACTMN" stand for?

ACTMN stands for Acetylcholine and is a neurotransmitter commonly measured in blood tests.

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What does "AST" stand for?

AST stands for Aspartate Aminotransferase. It is an enzyme found in the liver and is measured in blood tests to assess liver function.

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What does "BUN" stand for?

BUN stands for Blood Urea Nitrogen. It's a waste product produced by the body and is measured in blood tests to assess kidney function.

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What does "CA" stand for?

CA stands for Calcium. It's a mineral measured in blood tests to assess calcium levels and bone health.

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What does "CKI" stand for?

CKI stands for Creatine Kinase Isoenzyme. It is an enzyme primarily found in heart and skeletal muscles and is measured in blood tests to assess muscle damage.

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What does "CL" stand for?

CL stands for Chloride. It is a mineral electrolyte measured in blood tests to assess fluid balance and electrolyte levels.

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What does "CREA" stand for?

CREA stands for Creatinine. It's a waste product produced by muscles and measured in blood tests to assess kidney function.

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What does "CRP" stand for?

CRP stands for C-reactive protein. It is a protein that is produced by the liver in response to inflammation and is measured in blood tests to assess inflammation.

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What does "DGNA" stand for?

DGNA stands for Digoxin. It is a medication used to treat heart conditions. Digoxin levels are measured in blood samples to ensure appropriate dosing for the patient.

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ALT (Alanine Aminotransferase)

A blood test that measures the activity of the enzyme alanine aminotransferase (ALT), which is primarily found in the liver. Elevated ALT levels can indicate liver damage or disease.

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AST (Aspartate Aminotransferase)

A blood test that measures the activity of the enzyme aspartate aminotransferase (AST), which is found in the liver, heart, and skeletal muscles. Elevated AST levels can indicate damage to these organs.

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Albumin (ALB)

A blood test that measures the amount of albumin in your blood. Albumin is a protein that helps keep fluid in your bloodstream and is important for many functions in your body, including transporting hormones and drugs.

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ALP (Alkaline Phosphatase)

A blood test that measures the activity of the enzyme alkaline phosphatase (ALP), which is found in the liver, bone, and intestines. Elevated ALP levels can indicate liver disease, bone disorders, or problems with the intestines.

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Amylase (AMY)

A blood test that measures the concentration of amylase in the blood. Amylase is an enzyme that helps digest carbohydrates in your saliva and pancreas.

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Ammonia (AMM)

A blood test that measures the concentration of ammonia (NH3) in your blood. Ammonia is a waste product produced by the body, and high ammonia levels can be a sign of liver disease, kidney disease, or other conditions.

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LDH (Lactate Dehydrogenase)

A test that measures the activity of lactate dehydrogenase (LDH), which is an enzyme found in many tissues, including heart, liver, and muscles. Elevated LDH levels can indicate damage to these organs.

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BOHB (Beta-Hydroxybutyrate)

A blood test that measures the concentration of beta-hydroxybutyrate (BOHB) in your blood. BHB is a type of ketone body that is produced in the liver during periods of starvation or low carbohydrate intake.

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CK (Creatine Kinase)

A blood test that measures the activity of the enzyme creatine kinase (CK), which is found in skeletal muscle, heart muscle, and brain. Elevated CK levels can indicate muscle injury, a heart attack, or a stroke.

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Glucose (GLU)

A blood test that measures the concentration of glucose in your blood. Glucose is a type of sugar that is the primary source of energy for the body.

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Total Bilirubin (TBILI)

A blood test that measures the concentration of total bilirubin in your blood. Bilirubin is a breakdown product of heme, which is a part of red blood cells.

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Direct Bilirubin (DBILI)

A blood test that measures the concentration of direct bilirubin in your blood. Direct bilirubin is a type of bilirubin that is already attached to glucuronic acid, making it water soluble.

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Indirect Bilirubin (IBILI)

A blood test that measures the concentration of indirect bilirubin in your blood. Indirect bilirubin is a type of bilirubin that is not yet attached to glucuronic acid, making it fat-soluble.

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Creatinine (CREA)

A blood test that measures the concentration of creatinine in your blood. Creatinine is a waste product produced by the breakdown of muscle tissue.

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Analytical Measurement Range (AMR)

The range of values a test can accurately measure before dilution is required.

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Sample Volume (μL)

The volume of sample used in the analyzer's test run.

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Auto Dilute Sample Volume

The volume of sample taken before dilution is required.

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Dilution Factor

The factor by which the original sample is diluted.

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Manual Dilutions

A manual process of diluting a sample for testing, often used for high concentration samples.

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Clinical Reportable Range (CRR)

The range of values reported after considering dilutions.

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Diluent

A specific liquid used to dilute a sample for testing.

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GLUC

A test that measures the amount of glucose in blood and other body fluids.

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HCG

A test that measures the amount of human chorionic gonadotropin (hCG) in blood, often used to detect pregnancy.

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HDLC

A test that measures the amount of high-density lipoprotein cholesterol (HDL) in blood, often referred to as "good" cholesterol.

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FERR

A test that measures the amount of iron in the blood.

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LDI

A test that measures the amount of lactate dehydrogenase (LD) in the blood, which can indicate tissue damage.

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LIP

A test that measures the amount of lipase in the blood, which can indicate problems with the pancreas.

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K

A test that measures the amount of potassium in the blood, an important mineral for bodily functions.

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Study Notes

Siemens Dimension EXL and Vista Operating Procedure

  • Procedure Number: CHEM-0045
  • Version: 3.1
  • Effective Date: 1/4/2024
  • Last Approval/Periodic Review Completed: 11/11/2024
  • Next Periodic Review Needed On or Before: 11/11/2025
  • Approval and periodic review signatures are included, along with dates and details
  • List of approvals and reviewers, with their titles and dates, is provided.
  • Clinical Significance: Dimension Chemistry Systems perform various chemical tests on specimens (serum, plasma, fluid, and urine), including routine chemistry, drug assays, cardiac markers, and immunoassays.
  • Specimen Requirements: Detailed specifications for various specimen types (plasma, serum, urine, etc.)
  • Patient Preparation: General guidelines for patient preparation prior to specimen collection
  • Specimen Types: Lists common specimen types including Serum, Plasma, Urine, Body Fluids, and CSF.
  • Unacceptable Specimens: Criteria for unacceptable specimens, including clotting issues and improper sample preparation.
  • Procedure: Operating the Dimension EXL 200 and Vista 500/1500: Various steps in the procedure, including batch mode, open/close QC, manual QC, and testing procedures, have detailed descriptions
  • Quality Control (QC): System checks and probe tests required, along with temperature checks and frequency
  • Calibration: Separate Calibration procedures outlined for EXL and Vista
  • **Troubleshooting Unacceptable QC:**Troubleshooting steps for handling unacceptable QC results and solutions for different problems
  • Reviewing QC Results for EXL and Vista: includes methods for checking LJ charts, trends, and appropriate remedial action for issues
  • Batched Mode or Open/Close QC: Explains when and how to perform QC in batch mode
  • QC Preparation - Storage: Instructions on reagents and their storage
  • Equipment and Materials: Lists the equipment involved in tests.
  • Calibration: Instructions for calibration procedures
  • Maintenance: Daily, weekly, monthly, and as-needed maintenance guidelines.
  • Refers to the Operator's Guide for details
  • CAP Surveys and Interlabs: Details about ongoing surveys and evaluations/testing
  • Testing Procedures: Step-by-step instructions for specimen processing and loading.
    • Specificity for different specimen types
  • Reporting Results: Procedures on using HPL Reference Ranges
  • HIL Flags: Procedures for handling samples with hemolysis, lipemia, and icterus flags.
  • Reportable Ranges: Reference tables provide values for acceptable results, with notes on how to address "Above Assay Range" or "Below Assay Range" result status
  • Special Messages: Procedures and instructions on handling special messages (HIL)
  • Specimen/analyte details are also listed in separate tables for various tests

Delta failures

  • Refers to HPL approved critical value list on intranet.
  • Most critical values on chemistry instruments are automated to repeat.

Procedure for Operating the Dimension EXL 200 and Vista 500/1500

  • Detailed steps for operating the Dimension EXL 200 and Vista 500/1500 analyzers are provided.
  • Instructions on using the various menus and functions of the instrument
  • Explanation of different modes
  • Instructions on handling and reporting results

Procedure: Operating the Dimension EXL 200 and Vista 500/1500:

  • Includes detailed instructions on using different types of specimens (Serum, Plasma, Urine, CSF).

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

Description

Explore the operational procedures for the Siemens Dimension EXL and Vista Chemistry Systems. This quiz covers clinical significance, specimen requirements, patient preparation, and the types of specimens used in various chemical tests. Prepare to enhance your understanding of laboratory protocols and specimen handling.

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