Innovance Heparin Assay Overview
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Questions and Answers

What is the minimum required fill for a 3.2% Sodium Citrate tube?

  • 100%
  • 90% (correct)
  • 70%
  • 80%

How should the 3.2% sodium citrate solution be mixed with venous blood?

  • 2 parts solution to 8 parts blood
  • 1 part solution to 9 parts blood (correct)
  • 3 parts solution to 7 parts blood
  • 9 parts solution to 1 part blood

What should be checked in a whole blood specimen after collection?

  • Volume measurement
  • Color change
  • Clot formation (correct)
  • Viscosity

At what speed should the specimen be centrifuged to obtain platelet-poor plasma?

<p>2000 x g (C)</p> Signup and view all the answers

What task should be performed daily during maintenance?

<p>Check and discard trap chamber fluid (B), Document daily maintenance (C)</p> Signup and view all the answers

Which of the following maintenance tasks is NOT performed weekly?

<p>Remove condensation from reagent table (A), Remove water from tray No. 48 (B)</p> Signup and view all the answers

What is the recommended handling condition for the specimen after collection?

<p>Centrifuge as soon as possible after collection (A)</p> Signup and view all the answers

During the maintenance process, what should be done with used cuvettes?

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

What is one of the first tasks performed during the daily maintenance of the instrument?

<p>Instrument start up (A)</p> Signup and view all the answers

Which maintenance task focuses on the upkeep of internal components?

<p>Clean the Main Unit (D)</p> Signup and view all the answers

What should be done if specimen interference prevents obtaining results?

<p>Attach a comment stating results cannot be obtained. (B)</p> Signup and view all the answers

What action should be taken if results are reported as over range for Heparin?

<p>Report the result as &gt;1.5 IU/mL and confirm patient status. (D)</p> Signup and view all the answers

How should documentation be completed when crediting critical notifications?

<p>Document the RN's full name and time of notification. (B)</p> Signup and view all the answers

If the RN confirms that a patient is on an interfering anticoagulant, what should be noted?

<p>Document appropriately and add comments as required. (A)</p> Signup and view all the answers

What does the action for Heparin specify when laboratory results are acceptable?

<p>Attach a free text comment confirming patient medication status. (A)</p> Signup and view all the answers

What is the first step in the Innovance Heparin Assay procedure?

<p>Transfer calibrators into sample cups. (A)</p> Signup and view all the answers

How often should quality control be performed during patient testing?

<p>Every 8 hours of patient testing. (A)</p> Signup and view all the answers

What should be done after entering the calibrator value in the Innovance Heparin Assay?

<p>Scan the 2D barcode. (C)</p> Signup and view all the answers

What is NOT a reason to perform quality control in this procedure?

<p>After patient results have been printed. (C)</p> Signup and view all the answers

Which control is used for the INNOVANCE Heparin Level 1 Quality Control?

<p>INNOVANCE Heparin UFH Control level 1. (D)</p> Signup and view all the answers

What should be done after accepting the calibration in the Innovance Heparin Assay?

<p>Set and Print the results. (B)</p> Signup and view all the answers

What step comes immediately after selecting the test parameter in the procedure?

<p>Enter calibrator value in cursor. (C)</p> Signup and view all the answers

What type of sample cups should be used to transfer calibrators?

<p>2 mL or 4 mL sample cups. (B)</p> Signup and view all the answers

What is required every 30 days for laboratories reporting a derived fibrinogen result?

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

Which of the following tasks is part of the quarterly maintenance schedule?

<p>Performing LED calibration (B)</p> Signup and view all the answers

What should be verified before executing the Probe Rinse?

<p>That cleaners are set and contain sufficient volume (B)</p> Signup and view all the answers

What is the initial step in the instrument shutdown procedure?

<p>Turn off power, wait 15 seconds, and turn back on (D)</p> Signup and view all the answers

Which action is NOT mentioned as a task to be performed as needed?

<p>Performing LED calibration (B)</p> Signup and view all the answers

How long approximately does the probe rinse take?

<p>9 minutes (A)</p> Signup and view all the answers

What must be checked in the pneumatic trap chamber during maintenance?

<p>The presence of fluid (B)</p> Signup and view all the answers

In case the probe rinse needs to be initiated, what screen options should be followed?

<p>Press Special Menu &gt; Rinse Probe (C)</p> Signup and view all the answers

What is the approval date for the current version of the Innovance Heparin Assay document?

<p>3/28/2024 (B)</p> Signup and view all the answers

Who is responsible for the periodic review that should occur on or before 3/20/2025?

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

Which laboratory director approved the document on 3/28/2024?

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

What is the main purpose of the COAG-0035 document?

<p>Heparin assay protocols (B)</p> Signup and view all the answers

What version of the Innovance Heparin Assay document is currently approved?

<p>3.0 (C)</p> Signup and view all the answers

Which date marks the last periodic review completed?

<p>3/20/2024 (D)</p> Signup and view all the answers

Which of the following indicates that the document is uncontrolled?

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

What role does Thuy Sandy Pham hold in relation to the document?

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

When was the New Lab Approval conducted for version 2.0?

<p>9/14/2023 (B)</p> Signup and view all the answers

What is the next date listed for periodic review after the last review on 3/20/2024?

<p>3/20/2025 (B)</p> Signup and view all the answers

Which of the following individuals approved the document on 3/14/2024?

<p>Jeffery Green (A), Angie Duong (C)</p> Signup and view all the answers

Which system is mentioned as the previous system of record for document control?

<p>Master Control Document Records (B)</p> Signup and view all the answers

Which individual performed the periodic review recorded on 5/5/2023?

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

What is the purpose of the approval signatures in the document?

<p>To confirm the validity of the document (D)</p> Signup and view all the answers

Flashcards

Platelet-poor Plasma

Blood plasma with very few platelets. It's prepared by centrifuging a blood sample to separate the platelets.

Sodium Citrate Tube

A type of blood tube used to collect blood samples for certain types of tests. It contains a solution that prevents blood clotting.

Centrifugation

The process of spinning a blood sample at high speed to separate different components, like red blood cells, white blood cells, and plasma.

Centrifugal Force (g)

A measure of the force applied during centrifugation. It's expressed in units of 'g'.

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Specimen Age

The time a blood sample is allowed to sit before being used for testing. It can affect the test results because blood components can change over time.

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Laboratory Procedure

A document that outlines the procedures for performing a specific laboratory test. It includes essential information about the method, reagents, equipment, quality control, and safety procedures.

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Innovance Heparin Assay

A clinical laboratory test that measures the level of Heparin in a patient's blood sample.

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Revision Number

The version number of a document, indicating revisions and updates made over time.

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Approval Date

The date when a document was approved and finalized for use. It signifies the date of the latest valid version.

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Reviewer

The person responsible for reviewing the document for accuracy and completeness before it is approved.

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Approver

The person who authorizes and approves the content of the document.

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Periodic Review Date

The date when a document is scheduled for a regular review to ensure it remains up-to-date and accurate.

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Periodic Reviewer

The person who is responsible for performing the periodic review of the document.

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Organization

The organization responsible for implementing and managing the laboratory procedure.

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Effective Date

The date when the document becomes effective and can be used for laboratory testing.

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Approval Type

The type of approval given to the document. In this case, it signifies the document was approved by a Laboratory Director.

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Approval Signature Date

The specific date the document was approved.

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Approval Signature Name and Role

The person who approved the document and their role.

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Notes

A record of any changes made to the document.

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Controlled Copy

A document that has been approved and is the current version being used.

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Specimen Interference

A blood sample that is not suitable for certain tests because it contains substances that interfere with the test results. This can happen when a patient is taking heparin medication.

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Results Over Range

The highest allowable value for a test result. For the Innovance Heparin Assay, if the result is higher than 1.5 IU/mL, it's reported as 'over range'.

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Free Text Comment

A comment added to a lab report that explains why a test result is not available. It typically includes a statement confirming that the patient is not taking heparin medication.

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Interfering Anticoagulant

The use of a specific medication like heparin, which interferes with the Innovance Heparin Assay.

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Daily Instrument Start-up

The process of starting up the CS-2500 instrument, including checking and discarding trap chamber fluid, removing condensation, discarding used cuvettes, waste fluids, and documenting daily maintenance.

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Weekly Cleaning

The regular cleansing of the main unit and rinse tank of the CS-2500, ensuring optimal performance.

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Removing Water from Tray 48

The procedure of removing any excess water from tray number 48 on the CS-2500.

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Instrument Shutdown

The process of shutting down the CS-2500 instrument and discarding the fluid from the trap chamber.

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Maintenance Frequency

The recommended frequency at which specific maintenance tasks for the CS-2500 instrument are performed.

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INNOVANCE Heparin UFH Control & INNOVANCE Heparin LMWH Control

A set of controls used to ensure the accuracy of blood tests, especially for heparin levels.

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QC Frequency

The process of running the heparin blood test every 8 hours or whenever a new vial of Heparin is used.

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Weekly Maintenance

The process of cleaning the exterior and interior surfaces of the coagulation analyzer.

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LED Calibration

Calibration of the analyzer's light-emitting diodes (LEDs) to ensure accurate results.

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Consumable Check

Checking the status and availability of essential supplies for coagulation testing.

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Fuse Replacement

Replacing the fuse in the coagulation analyzer.

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Printer Paper Replacement

Replacing the paper used in the printer of the coagulation analyzer.

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Rinse & Prepare

A specialized cleaning process that prepares the coagulation analyzer for testing.

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Clean Sample Probe

A cleaning process for the sample probe, the part that draws blood into the coagulation analyzer.

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Drain Trap Chamber

The process of removing fluid from the trap chamber in the coagulation analyzer to prevent clogging.

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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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Related Documents

Innovance Heparin Assay Sysmex CS-2500 and CA-660 Procedure PDF, 3/20/2024

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.

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