Podcast
Questions and Answers
What is the minimum required fill for a 3.2% Sodium Citrate tube?
What is the minimum required fill for a 3.2% Sodium Citrate tube?
How should the 3.2% sodium citrate solution be mixed with venous blood?
How should the 3.2% sodium citrate solution be mixed with venous blood?
What should be checked in a whole blood specimen after collection?
What should be checked in a whole blood specimen after collection?
At what speed should the specimen be centrifuged to obtain platelet-poor plasma?
At what speed should the specimen be centrifuged to obtain platelet-poor plasma?
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What task should be performed daily during maintenance?
What task should be performed daily during maintenance?
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Which of the following maintenance tasks is NOT performed weekly?
Which of the following maintenance tasks is NOT performed weekly?
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What is the recommended handling condition for the specimen after collection?
What is the recommended handling condition for the specimen after collection?
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During the maintenance process, what should be done with used cuvettes?
During the maintenance process, what should be done with used cuvettes?
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What is one of the first tasks performed during the daily maintenance of the instrument?
What is one of the first tasks performed during the daily maintenance of the instrument?
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Which maintenance task focuses on the upkeep of internal components?
Which maintenance task focuses on the upkeep of internal components?
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What should be done if specimen interference prevents obtaining results?
What should be done if specimen interference prevents obtaining results?
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What action should be taken if results are reported as over range for Heparin?
What action should be taken if results are reported as over range for Heparin?
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How should documentation be completed when crediting critical notifications?
How should documentation be completed when crediting critical notifications?
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If the RN confirms that a patient is on an interfering anticoagulant, what should be noted?
If the RN confirms that a patient is on an interfering anticoagulant, what should be noted?
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What does the action for Heparin specify when laboratory results are acceptable?
What does the action for Heparin specify when laboratory results are acceptable?
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What is the first step in the Innovance Heparin Assay procedure?
What is the first step in the Innovance Heparin Assay procedure?
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How often should quality control be performed during patient testing?
How often should quality control be performed during patient testing?
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What should be done after entering the calibrator value in the Innovance Heparin Assay?
What should be done after entering the calibrator value in the Innovance Heparin Assay?
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What is NOT a reason to perform quality control in this procedure?
What is NOT a reason to perform quality control in this procedure?
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Which control is used for the INNOVANCE Heparin Level 1 Quality Control?
Which control is used for the INNOVANCE Heparin Level 1 Quality Control?
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What should be done after accepting the calibration in the Innovance Heparin Assay?
What should be done after accepting the calibration in the Innovance Heparin Assay?
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What step comes immediately after selecting the test parameter in the procedure?
What step comes immediately after selecting the test parameter in the procedure?
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What type of sample cups should be used to transfer calibrators?
What type of sample cups should be used to transfer calibrators?
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What is required every 30 days for laboratories reporting a derived fibrinogen result?
What is required every 30 days for laboratories reporting a derived fibrinogen result?
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Which of the following tasks is part of the quarterly maintenance schedule?
Which of the following tasks is part of the quarterly maintenance schedule?
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What should be verified before executing the Probe Rinse?
What should be verified before executing the Probe Rinse?
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What is the initial step in the instrument shutdown procedure?
What is the initial step in the instrument shutdown procedure?
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Which action is NOT mentioned as a task to be performed as needed?
Which action is NOT mentioned as a task to be performed as needed?
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How long approximately does the probe rinse take?
How long approximately does the probe rinse take?
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What must be checked in the pneumatic trap chamber during maintenance?
What must be checked in the pneumatic trap chamber during maintenance?
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In case the probe rinse needs to be initiated, what screen options should be followed?
In case the probe rinse needs to be initiated, what screen options should be followed?
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What is the approval date for the current version of the Innovance Heparin Assay document?
What is the approval date for the current version of the Innovance Heparin Assay document?
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Who is responsible for the periodic review that should occur on or before 3/20/2025?
Who is responsible for the periodic review that should occur on or before 3/20/2025?
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Which laboratory director approved the document on 3/28/2024?
Which laboratory director approved the document on 3/28/2024?
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What is the main purpose of the COAG-0035 document?
What is the main purpose of the COAG-0035 document?
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What version of the Innovance Heparin Assay document is currently approved?
What version of the Innovance Heparin Assay document is currently approved?
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Which date marks the last periodic review completed?
Which date marks the last periodic review completed?
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Which of the following indicates that the document is uncontrolled?
Which of the following indicates that the document is uncontrolled?
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What role does Thuy Sandy Pham hold in relation to the document?
What role does Thuy Sandy Pham hold in relation to the document?
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When was the New Lab Approval conducted for version 2.0?
When was the New Lab Approval conducted for version 2.0?
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What is the next date listed for periodic review after the last review on 3/20/2024?
What is the next date listed for periodic review after the last review on 3/20/2024?
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Which of the following individuals approved the document on 3/14/2024?
Which of the following individuals approved the document on 3/14/2024?
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Which system is mentioned as the previous system of record for document control?
Which system is mentioned as the previous system of record for document control?
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Which individual performed the periodic review recorded on 5/5/2023?
Which individual performed the periodic review recorded on 5/5/2023?
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What is the purpose of the approval signatures in the document?
What is the purpose of the approval signatures in the document?
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Study Notes
Innovance Heparin Assay
- Assay Title: Innovance Heparin Assay
- Method: Sysmex CS-2500 and CA-660
- Version: 3.0
- Effective Date: 3/20/2024
- Approval Date: 3/28/2024
- Review Date: 3/20/2024
- Periodic Review: 3/20/2025
- Assay Purpose: Automated, one-stage chromogenic assay to quantify heparin activity (UFH and LMWH) in patient plasma
- Principle: Heparin inactivates thrombin and factor Xa by binding to antithrombin. The assay measures the remaining Xa activity in the sample. The conversion of a chromogenic substrate by Xa is reduced in the presence of heparin, allowing this reduction to be measured.
- Specimen Type: Platelet-poor plasma
- Specimen Volume: 3.2% Sodium Citrate (minimum 90% fill), venous blood
- Handling: Check for clots. Centrifuge immediately at ~2000 x g for 15 minutes to obtain platelet-poor plasma.
- Specimen Storage: Room temperature: 4 hours; Frozen at ≤-18°C: 3 days; Frozen at ≤-74°C: 3 months
- Unacceptable Specimens: Clotted, hemolyzed, lipemic, or icteric; specimens overfilled or underfilled; incorrect anticoagulant; >4 hrs old unless frozen.
- Equipment: Sysmex CS-2500 and CA-660 analyzers, reagents (Xa and chromogenic substrate)
- Reagents Storage and Stability: Varies by reagent and storage conditions
- Calibration: Performed every 6 months, with every new lot and after maintenance.
- Quality Control: Two sets of two levels of QC performed every 8 hours, when reagents are changed and after calibration
- Reporting Results: Results reported in IU/mL; do not report dOD results
- Therapeutic Ranges: UFH: 0.3 - 0.7 IU/mL, LMWH: 0.6 - 1.0 IU/mL
- Clinical Reportable Range: 0.10 - 1.50 IU/mL
- Critical Results: ≥ 1.0 IU/mL
- Limitations: Assay not established in neonates or pediatrics. May yield different results compared to other methods. Turbidity/particles may interfere, requiring centrifugation. Certain medications may interfere.
Trouble shooting
- Over Range Results: Do not report numeric result, mark as interference, and document this.
Maintenance
- Daily Maintenance: Instrument shutdown, check and discard trap chamber fluid, check and record temperatures
- Monthly Maintenance: Replace trash box liner, document weekly maintenance, clean filters..
- As Needed Maintenance: Remove Cuvette blockages
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Description
This quiz covers the Innovance Heparin Assay, an automated chromogenic assay for measuring heparin activity in patient plasma. Learn about the assay's principles, methods, specimen handling, and storage requirements. Understand the significance of this assay in clinical settings and its effective implementation.
