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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE. 510(k) Number: #K032017 B. Analyte: Dimer C. Type of Test: N/A D. Applicant: Bird Laboratories E. Proprietary and

How to fill out d-dimer

How to fill out d-dimer:

1. Start by gathering all necessary materials, including a blood collection tube, needle, alcohol swab, and a d-dimer test request form.
2. Before beginning, ensure that you have the appropriate training and authorization to perform blood collection.
3. Wash your hands thoroughly and put on disposable gloves to maintain cleanliness and prevent contamination.
4. Identify the patient and confirm their identity by asking for their full name and date of birth. Cross-reference this information with their identification bracelet or any other reliable source.
5. Explain the procedure to the patient and address any concerns they may have. It is essential to obtain informed consent before proceeding.
6. Select an appropriate venipuncture site, typically the antecubital fossa, and prepare the area by cleaning it with an alcohol swab in a circular motion from the center outward.
7. Allow the cleaned area to air dry completely to ensure the effectiveness of the disinfection process.
8. Put on a tourniquet, making sure it is tight enough to restrict venous outflow but not impede arterial circulation.
9. Ask the patient to make a fist or open and close their hand multiple times to engorge the veins.
10. Locate the most suitable vein and anchor it by applying gentle traction or tapping it.
11. Using a sterile needle, insert it smoothly and swiftly into the vein at an angle of approximately 15-30 degrees, ensuring it enters the lumen successfully.
12. Once blood flow is established, gently attach the blood collection tube to the needle hub and allow enough blood to fill the tube according to the laboratory's requirements.
13. Apply slight pressure over the puncture site using sterile gauze or a cotton ball to prevent bleeding.
14. Withdraw the needle smoothly, release the tourniquet, and ask the patient to extend their arm while you inspect the puncture site for any signs of hematoma or bleeding.
15. Dispose of the needle safely in a sharps container, ensuring that it is not accessible to others.
16. Label the blood collection tube accurately with the patient's name, date of birth, and the time of collection.
17. Complete the d-dimer test request form, ensuring that all relevant information, such as the patient's demographics and pertinent clinical details, is included.
18. Place the labeled blood collection tube and the completed request form in a biohazard bag and transport it to the laboratory promptly, following proper handling and storage guidelines.

Who needs d-dimer:

1. Individuals who present symptoms of deep vein thrombosis (DVT), such as swelling, pain, or warmth in the legs.
2. Individuals who exhibit symptoms of pulmonary embolism (PE), such as shortness of breath, chest pain, or coughing up blood.
3. Patients with a history of blood clotting disorders or a previous thrombotic event.
4. Individuals who have recently undergone surgery or prolonged immobility, as they are at an increased risk of blood clots.
5. Pregnant women, as their blood clotting properties may be altered during pregnancy.
6. Patients who have experienced unexplained strokes or other arterial thromboembolic events.
7. Individuals with suspected disseminated intravascular coagulation (DIC) or other coagulation disorders.
8. Those undergoing cancer treatment, as certain forms of cancer can increase the risk of blood clots.
9. Patients with suspected ruptured abdominal aortic aneurysm (AAA).
10. Individuals who have experienced trauma or sustained injuries, particularly involving the lower extremities.

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What is d-dimer?

D-dimer is a protein fragment that is produced when a blood clot dissolves in the body.

Who is required to file d-dimer?

D-dimer tests are usually ordered by healthcare providers to help diagnose or rule out blood clotting disorders.

How to fill out d-dimer?

A blood sample is taken from a vein in the arm and sent to a laboratory for analysis.

What is the purpose of d-dimer?

The purpose of d-dimer testing is to help diagnose conditions related to blood clotting, such as deep vein thrombosis (DVT) or pulmonary embolism.

What information must be reported on d-dimer?

The d-dimer test results, along with the patient's medical history, symptoms, and other test results, are all important information that must be considered.