D.8 POC-010-Coaguchek XS Plus.pdf

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DETROIT

D

VA

MEDICAL

CENTER

JOHN D. DINGELL VA MEDICAL CENTER

PATHOLOGY & LABORATORY MEDICINE

SERVICE

Issue Date:

01 -12- 12

Document ID:

2012-POC-010

Written By: Beverly A. Jones, MT(ASCP) Revision: REVISED:

Approved By: Nabiha Khoury, MD 1.2 02-18-2016

CoaguChek Plus INR Testing

“Policies and procedures cannot possibly address all situations. Please make sure that you exercise good judgement and common sense. Remember patient needs come first”

PRINCIPLE OF OPERATION

Use

The CoaguChek XS PT Test strip, used as directed with the CoaguChek XS Plus meter, provides accurate whole blood determination of the prothrombin time (INR) used for monitoring oral anticoagulant (Warfarin) therapy.

Test principle

The CoaguChek XS PT Test, used as directed with the CoaguChek S Plus meter, will provide an electrochemical measurement of prothrombin time following activation of blood coagulation with human recombinant thromboplastin. In simple terms, blood works with the chemicals in the test strip to make a small electric current in the test strip that measures blood clotting time.

WHO reference

In 1983, the World Health Organization (WHO) adopted this calibration system and made recommendations for its implementation to allow all thromboplastins of varying sensitivity in any laboratory for oral anticoagulant control to be calibrated against a reference thromboplastin of human brain with an ISI (International Sensitivity Index) of 1.0.

TEST STRIP STORAGE AND HANDLING

Purpose

The following policy is intended to help operators with correct strip handling and storage.

Ingredients

Each CoaguChek XS PT test strip contains reagent (human recombinant thromboplastin 1.5 U), stabilizers, preservatives, and additives.

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POLICY—Test Strip Storage and Handling

• Strips are intended for in vitro diagnostic use only.

• Exercise normal precautions when handling laboratory reagents. Follow JDDVAMC facility infection control guidelines.

• Store the test strips in their container with the cap closed.

• You can store the test strips at room temperature or in the refrigerator (36°F to 86°F or

2°C to 30°C).

• When stored properly, the test strips can be used until the expiration date printed on the test strip container.

• When you are ready to test, open the test strip container and remove one strip from the container. Immediately close the container. Make sure it seals tightly.

• Dispose of the test strips if they are past their “Use By” date.

• Use the test strip within 10 minutes after removing it from the container.

• Do not open a vial of test strips or touch a test strip with wet hands or gloves. This may damage the test strips.

• Close the container tightly.

Coding the Meter with the Test Strip Code Chip

PURPOSE

The following procedures provide instructions for matching the code chip to the test strip lot and changing the test strip code chip. The test strip code chip provides the meter with important information that it needs to perform the coagulation test.

The chip contains information about the test method, the lot number and the expiration date.

POLICY—Coding the Meter with the Test Strip Code Chip

• The test strip code chip is required when a new test strip container is opened to store the lot information about the test strips in the meter.

• The CoaguChek XS Plus meter stores the data from up to 60 code chips.

• Use the test strip code chip that was supplied with each new test strip container before you perform the first test.

• Leave the code chip in the meter to protect the electrical contacts in the meter from becoming dirty.

• Each code chip belongs to a particular lot of test strips. Only remove the code chip when you are testing with test strips taken from a new pack (with a new code chip).

• Protect the code chip from moisture and equipment that produces magnetic fields.

PROCEDURE—Matching Code Chip to Test Strip

1. Before each test, make sure the correct code chip is in the meter.

2. The 3-number code on the test strip container must match the

3-number code on the code chip.

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3. To install the code chip, follow the instructions below. Have the code chip ready.

PROCEDURE—Inserting the Test Strip Code Chip

1. Be certain the meter is OFF.

2. Remove the old code chip if there is one inserted in the meter. Store the code chip with appropriate strip lot.

3. Insert the code chip into the code chip slot in the meter with the printed side facing UP until it snaps into place.

• Always compare the code number you see on the display with the number that is printed on the test strip container you are using. If the two code numbers do not match, insert the correct code chip in the slot in the meter.

• If the code chip is missing or incorrectly inserted, error messages appear in the display

Patient Preparation

The following policy and procedure provides instruction for preparing a patient for testing on the CoaguChek XS Plus System.

POLICY—Patient Preparation

• Operators must use both the full patient name and nine digit social security number as identifiers before testing to ensure accurate patient testing.

• Before performing the test, the operator explains to the patient the purpose and steps of the procedure.

• Observe universal precautions based on the JDDVAMC infection control guidelines.

• Exercise precautions required for handling all blood specimens and laboratory reagents.

• Operators must wash hands before and after testing.

• Operators must wear disposable gloves when collecting blood samples or performing tests.

• If possible, have patients wash hands prior to testing.

• Dispose of used test strips, lancets, and venipuncture supplies in the appropriate designated biohazard or sharps containers.

PROCEDURE—Patient Preparation

1. Explain the purpose and steps of the testing procedure to reassure the patient.

2. Wash your hands and put on disposable gloves prior to testing.

3. Collect blood sample following the procedure in the Specimen Collection and

Handling section below.

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Specimen Collection and Handling

The following policies and procedures provide instructions for collecting, handling, and rejecting patient test specimens.

POLICY—Specimen Collection and Handling

• The CoaguChek XS Plus System test may be performed with fresh capillary whole blood from a fingerstick.

• The results are unaffected by heparin concentrations up to 0.8 U/mL.

• The CoaguChek XS PT Test is insensitive to low molecular weight heparins (LMWH) up to 2 IU anti-factor Xa activity/mL.

• The blood sample must be applied to the test strip within ten minutes of removing the test strip from its container.

• The meter should display the flashing test strip and blood drop symbols prior to sample collection.

• Capillary sample must be applied to the strip within 15 seconds of the fingerstick.

• Minimum sample size is 10 µL of blood.

POLICY—Rejecting Specimens

• Venous sample, Plasma or serum CANNOT be used as a testing sample.

• Sample size CANNOT be less than 10 µL.

• Additional blood sample CANNOT be added to the test strip once testing has begun.

POLICY—Blood Application

• Apply directly from the finger to the test strip.

PROCEDURE—Direct fingerstick sample collection

1. Gather the following:

• CoaguChek XS Plus meter

• CoaguChek XS PT Test strips and matching code chip

• CoaguChek Lancet or other lancet device

• Alcohol wipe or soap and water

• Gauze or cotton ball

• Bandages

2. Warm the hand. Have the patient hold it under his or her arm, use a hand warmer, or wash with warm water.

3. Have the patient let that arm hang down by his or her side before lancing a finger.

4. Massage the finger from its base

5. Clean the selected finger with alcohol wipe or use soap and warm water.

Allow to air dry completely.

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6. When the meter displays the flashing test strip and blood drop symbols, with the hand still down, stick the side of finger with a lancet.

• DO NOT WIPE AWAY THE FIRST DROP OF BLOOD.

• DO NOT puncture the finger until the flashing test strip and blood drop symbols appear on the meter screen.

7. Immediately after lancing, massage gently along the side of the finger to obtain a good blood drop without pressing or squeezing too hard.

8. While the flashing test strip and blood drop symbols appear on the display, apply the first drop of blood (within 15 seconds) as outlined in Testing a Patient Sample.

• Hold the blood drop to the strip until the meter beeps (providing beeper is set to ON).

• DO NOT apply a second drop or disturb the strip while testing.

Testing a Patient Sample

Note: Medical staff and other persons using the CoaguChek XS Plus meter to perform tests on more than one patient must be aware that any object coming into contact with human blood is a potential source of infection. The CoaguChek XS Plus meter must be cleaned after testing of each patient.

PURPOSE

The following policy and procedure provides instructions for testing a patient sample.

POLICY—Testing a Patient Sample

• Only a certified operator may perform a test with the CoaguChek XS Plus System.

• Tests are performed with the CoaguChek XS Plus System only in response to written or electronic requests from an authorized person.

• Oral requests are permitted only if written authorization for testing is obtained within 30 days.

• Because of the hazards of handling blood products, wear disposable gloves when collecting specimens and performing test procedures.

• Observe and use universal precautions for all blood specimens.

• Refer to JDDVAMC infection control procedures for proper disposal of blood-contaminated items in compliance with OSHA and CDC regulations for universal precautions.

PROCEDURE—Testing a Patient Sample

1. Prepare the lancet device or venipuncture supplies according to the manufacturer’s instructions.

2. Place meter on a flat surface, free of vibrations. Or hold it in your hand so the meter is roughly horizontal. Do not move the meter during testing.

3. Take a test strip out of the container. Close the container tightly.

4. Hold the test strip so the lettering “CoaguChek XS PT” is facing upward.

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5. Slide the test strip into the test strip guide in the direction indicated by the arrows.

6. Slide the test strip in as far as it will go. This turns the meter ON. A beep tone indicates that the meter has detected the test strip (provided the beeper is turned on in the settings).

7. Check the battery level. If there are no bars left in the battery symbol, you cannot perform any more tests.

• If a lockout (OP. or QC Lockout) is displayed instead of PATIENT TEST, you must run a quality control before you can perform a test.

(Refer to Quality control procedure.) When the meter is in lockout status, a test cannot be performed.

8. Enter your operator ID..

9. Touch [OK] to log on and move to the main menu.

10. Touch PATIENT TEST.

11. Select or enter Patient ID.

12. Touch [OK]. An hourglass symbol indicates the test is warming up.

13. Confirm that the code number displayed on the meter matches the number on the test strip container.

• If the numbers are different, make sure you are using the code chip that came with the test strips you are using.

14. The blood drop symbol flashes to indicate that the meter is ready to perform the test and is waiting for blood to be applied. The 120-second countdown begins.

• DO NOT obtain sample until the flashing drop of blood appears on the display. Strip must be used within ten minutes of removing it from the container.

15. Identify the sample target area on the test strip.

16. Collect the fingerstick as outlined below.

• Fingerstick sample – DO NOT wipe away the first drop of blood.

Apply the first drop of blood to the top or side of the target area within 15 seconds of puncture. Hold the blood drop to the test strip until you hear a beep (provided the beeper is set to ON ).

17. Apply the blood directly to the semicircular, transparent sample application area of the test strip.

18. You hear a beep tone when you have applied enough blood (provided the beeper is turned on). The blood drop symbol disappears and the test starts.

Note: DO NOT add more sample. DO NOT touch the test strip or move the meter until the result is displayed.

19. The meter automatically performs a two-level, on-board quality control test on the test strip before it displays the test result. “QC” appears in the display.

20. Following a successful outcome of the quality control test, a check mark appears after “QC.”

21. You must WAIT for results—this takes about one minute

22. The result is displayed in the unit of measure you chose when setting up the meter. It is automatically saved to memory.

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23. Read and record results.

24. After the test results are displayed, a strip and arrow symbols appear on the screen, prompting you to remove the strip.

25. Remove the test strip from the measurement chamber.

26. Turn meter OFF.

27. Dispose of all biohazardous material in the appropriate designated biohazard or sharps container.

Note: Use a new fingerstick from the opposite hand and a new test strip if you must retest. DO NOT add more blood to the first test strip.

Interpreting Test Results

The following policies and procedures assist you with interpreting test results.

POLICY—Interpreting Test Results

Any unexpected results should always be followed up with an immediate call to the attending physician. A Panic Value is a PT result that is above or below the Immediate Follow-up Values set by the provider. Panic Values should always be followed up with an immediate call to the provider.

Patient Test Results:

• The CoaguChek XS Plus meter displays test results in units equivalent to laboratory plasma measurements.

• Results will be displayed as follows:

International Normalized Ratio (INR=(PT/Mean Normal PT))

• Each lot of test strips is calibrated to a reference lot that is traceable to the WHO International Reference Preparations. Normal INR levels vary from person to person.

• For the purpose of providing universal INR results, the Mean Normal Prothrombin Time (MNPT) has been established as 12 seconds and the ISI for the system has been established as 1.0.

• Differences in reagents, instruments, and pre-analytical variables can affect prothrombin time results. These factors should be considered when comparing different prothrombin time test methods.

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Therapeutic Range:

The appropriate Therapeutic Range for individuals undergoing conventional warfarin therapy is typically from 2.0 to 3.0 INR. Individuals who receive more intense therapy, such as mechanical valve replacement patients, often have a target from 2.5 to 3.5 INR.

The provider must determine the best INR level depending on the reason for anticoagulant treatment and how each individual respond to treatment (based on Prothrombin Time).

Each provider should establish expected values for his or her patient population or individual patients.

Critical results:

• INR results greater than 4 must be reported to the provider immediately. It is the responsibility of the operator performing the test to notify the provider of all patient results greater than 4.

• Taking verbal orders, telephone orders or test results require a verification “read back” of the complete order or test result by the person receiving the order or test result.

• When INR results are >4, a PT/INR test must be ordered and a blood sample should be drawn and sent to the clinical laboratory for validation.

Unusual Results:

• Certain drugs may affect results by interfering with warfarin pharmacology. The potential effect of a drug interaction with warfarin or the effect of underlying diseases (e.g. liver disease, congestive heart failure) must be considered when interpreting a result.

• Changes in the patient’s diet can cause unusually low or high results.

• Any unusual result can be followed up with inquiries to define the cause of the unusual result. If the result does not match the clinical symptoms, repeat the patient test to rule out procedural error.

PROCEDURE—Interpreting Test Result

1. If the meter displays a message other than a result, repeat the test. If the problem continues, notify the Ancillary Testing Coordinator for assistance.

2. If a < 0.8 INR or > 8.0 INR is displayed, the test result could not be measured, or the result may be outside the measuring range for the particular lot of test strips. Repeat the test with a new strip and a new fingerstick. If the problem continues, send a patient sample to the clinical laboratory for testing and notify the Ancillary Testing Coordinator for assistance.

Note: In rare cases, Error Message 7 can occur in patients with long coagulation times (> 8 INR). If this error message appears again when the test is repeated, the result must be checked using another method. A venous blood sample must be obtained and sent to the laboratory for testing.

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3. If the meter displays an unusual test result (other than an error message), check the following items:

• Check that the correct code chip is in the meter. The 3-number code on the test strip container must match the 3-number code on the code chip.

• Check that the meter is set up with the correct date and time. The expiration date of the strips is programmed into the code chip and is compared to the date on the meter. Therefore, it is important that the date and time be programmed correctly on the meter.

4. Debris on the test strip guide can cause problems with results. Clean the meter as recommended.

• Do not use a spray to clean the guide or any part of the meter.

• Do not let liquid enter the meter.

• Follow the meter cleaning instructions in the Meter Cleaning

Section of this procedure.

Documenting Test Results

The following procedure provides instructions for documenting test results. The test result is displayed in the unit of measure you chose when setting up the meter. It is automatically saved to memory. If the memory is full when you perform a test, the oldest result is automatically deleted. The most recent result is always saved. In the memory display, you can scroll through additional results or return to the main menu.

PROCEDURE—Documenting Test Results

1. Return the CoaguChek XS Plus meter to the cradle for automatic download to the

RALS IMS.

2. All critical results must be followed up according to medical center policy, 11LAB-58 Critical Test Results.

3. Any unusual result can be followed up with inquiries to define the cause of the unusual result. If the result does not match the clinical symptoms, repeat the patient test to rule out procedural error. If the result still does not match, a venous sample must be obtained and sent to the clinical laboratory for testing.

4. “Patient care decisions cannot be made based on Point of Care test results unless results are in the patient record.” POC test results may be uploaded into the electronic medical record after decision making.

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Critical Results Reporting

a. During administrative hours (Monday through Friday 0800-1630) the following procedures should be followed:

(1) The testing service will identify and notify the patient’s provider. If the patient is located in the Emergency Department, the ED physician or the ED nurse can be notified of critical results.

(2) If unable to contact the patient’s provider, the Chief of the respective service or designee will be contacted and given the patient’s name, social security number, provider name and the critical test result.

(3) If notified, the Chief of the service will have ultimate responsibility to provide appropriate follow-up.

(4) The following information will be provided to the ordering individual or Chief of service; patient name, test ordered, and critical result. The receiving individual will read back what they have heard. The individual initiating the call will document the following: the full name of the person you spoke with, the initial time the provider was paged, the date and time the provider was notified, the critical test result and that the information was verified by read back.

b. During non-administrative hours (after 1630, weekends, and holidays) the following procedures should be followed:

(1) Inpatient- The testing service will contact the primary physician or on-call physician (as indicated by the on-call schedule) and provide them with the patient’s name, test ordered, and critical result.

(2) Outpatient or CBOC patient- The testing service will contact the Medical Officer of the Day (MOD) and inform him/her of the patient’s name, test ordered, and critical result. The receiving individual will repeat back what they have heard. The individual initiating the call will document the following: the full name of the person you spoke with, the initial time the provider was paged, the date and time the provider was notified, the critical test result and that the information was verified by read back.

(3) It is up to the provider receiving the critical test result (Inpatient = primary physician or physician on-call; Outpatient = MOD; or Emergency Department = ED physician or ED Nurse) to determine the urgency of treatment and follow-up. If deemed necessary, the MAA will attempt to contact the patient via telephone, night letter, local police, etc. and inform the patient of the critical test result and request that he/she report to the VAMC Emergency Department as soon as possible for medical evaluation or admission if necessary or advise the patient to seek immediate treatment at the closest community emergency room if the situation warrants.

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Quality Control Testing

The following procedure provides instruction for performing and documenting liquid quality control testing.

Ingredients

Each control bottle contains non-human plasma with varied levels of coagulation factors, stabilizers, and preservatives. Each diluent filled dropper contains a calcium chloride solution with preservatives.

POLICY—Liquid Quality Control Testing

Liquid quality control testing of both levels of control is performed Weekly.

• Read control instructions thoroughly before using the controls.

• If you are using test strips from a new unopened container, you will need to change the test strip code chip. (The meter recognizes only those test strips that match the test strip code chip.)

NOTE: The three-digit code on the test strip container must match the code on the test stripcode chip. The CoaguChek XS Plus meter displays the control range and the result. The reading is automatically saved in the memory of the CoaguChek XS Plus meter.

• Acceptable CoaguChek XS Plus PT Controls ranges are displayed on the meter when each Quality Control test is run.

• The system is working properly and all handling has been done correctly when the test results obtained are within the acceptable control range.

• If a quality control test result is within the acceptable control range, it is appropriate to proceed with patient testing.

Unacceptable Control Results:

• An out-of-range result is indicated by an arrow. An arrow pointing up means the result is too high. An arrow pointing down means the result is too low. To resolve out-of-range results or error messages, check for the following:

• Controls may be expired or stored improperly.

• The control may not have been used within 30 minutes of reconstitution.

• You may not be doing the test correctly. Repeat the control test, using a new test strip. Carefully follow the instructions in the User Manual.

• Make sure you run the test within 10 minutes of removing the test strip from its container.

• If you follow all these guidelines and your results are still unacceptable, contact the

Ancillary Testing Coordinator for assistance.

• The appropriate quality control frequency is once each day of testing.

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POLICY— Liquid Control Storage and Handling

• For in vitro diagnostic use. Do not take internally.

• Exercise the normal precautions required for handling all laboratory reagents.

• Store controls in refrigerator at 36°F to 46°F (2° to 8°C) DO NOT FREEZE.

• Unopened, lyophilized controls that are stored in the refrigerator are good for 18 months or until the expiration date, whichever comes first.

• Discard any outdated controls.

• Controls are stable for 30 minutes after adding the diluent.

POLICY—Documenting Liquid Quality Control Testing Results

• Liquid quality control records (RALS IMS) are retained for two years.

• All quality control results, along with any corrective action to restore that result to the acceptable range, are recorded on a quality control log. This log (RALS IMS) includes the test strip lot number and expiration dates, control solution lot number and expiration dates, meter serial number, control ranges, operator identification, and date the test was performed.

• The Ancillary Testing Coordinator reviews the liquid quality control log (RALS IMS) for completeness, and notes any trends that indicate potential problems. Such trends include:

gradual drifting of values, sudden shifts in control values while using the same lot of strips, and differences in operator performance.

• The liquid quality control log is reviewed (RALS IMS) monthly by the ATC.

• An audit trail (RALS IMS) links the liquid control test with the appropriate CoaguChek

XS Plus meter, test strip lot, and control solution lot used for quality control testing.

Quality control testing information is also traceable to patient test results.

PROCEDURE—Preparing a Liquid Quality Control

1. Gather Supplies

• CoaguChek XS Plus meter

• CoaguChek XS PT Test strip(s) with matching test strip code chip

• CoaguChek XS Plus PT Controls: Level 1 and/or 2 with matching quality control code chip

• Diluent dropper(s): one for each control to be run

• Scissors

2. Insert the quality control code chip into the meter. This tells the meter the acceptable ranges for this box of controls.

3. Remove the screw-cap and rubber stopper from the quality control bottle. Label the bottle with the date and time that you reconstitute it.

4. Using scissors, cut off the tip of the dropper at the end of the stem. Hold the dropper a safe distance from your face.

CAUTION: To avoid loss of diluent, hold the dropper by the stem; do not squeeze the bulb of the dropper while cutting the tip.

5. Invert the dropper and place the tip into the bottle.

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6. Gently squeeze the bulb to dispense all of the contents of the dropper over the dried material. Do not allow the dropper to touch the dried material.

IMPORTANT: Make sure you dispense ALL the diluent.

7. Remove the dropper from the bottle. DO NOT discard the dropper. Replace the cap first and gently swirl the bottle to dissolve the quality control. Do not shake or invert the quality control. Make sure that all control material is completely dissolved before you test it.

8. Use the reconstituted quality control within 30 minutes from the time the diluent is added.

PROCEDURE—Liquid Quality Control Testing

1. Place the meter on a flat surface, free of vibrations. Or hold it in your hand so it is roughly horizontal. Do not move the meter during testing.

2. When you are ready to test, remove one test strip from the container and immediately close the container. Make sure it seals tightly.

IMPORTANT: Do not open a container of test strips or touch a test strip with wet hands or gloves. This may damage the test strips.

3. Use the test strip within 10 minutes of removing it from the container.

Otherwise, you may get an error message and you will have to repeat the test.

4. Hold the test strip so the lettering “CoaguChek XS PT” is facing upward.

5. Slide the test strip into the test strip guide in the direction indicated by the arrows.

6. Slide the test strip as far as you can into the meter. This turns the meter ON. A beep tone indicates that the meter has detected a test strip (provided the beeper is turned on in the settings).

7. Check the battery level. If there are no bars left in the battery symbol, you cannot perform any more tests.

8. Check that the date and time are correct.

9. Touch QC TEST.

10. The meter automatically checks to see if you have the right test strip code chip. The three-digit code on the test strip container must match the number on the test strip code chip before the test can be run.

11. If you are using a new test strip lot and have not inserted the test strip code chip yet, you must do so now.

12. Select the code already stored for your current control solution, or touch NEW CODE to use a new control solution.

Note: When you first run your control, the QC TEST screen will not display. This screen will display the next time you use the control.

13. If you are using a new control solution, remove the code chip from the meter and insert the code chip that came with the control solution instead.

14. Select level for this control test measurement. (L1 or L2)

15. The hourglass symbol shows that the test strip is warming up.

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16. The dropper symbol flashes to indicate that the meter is ready to perform the test and is waiting for the control solution to be applied. A 120-second countdown begins.

• You must apply the control sample within this time. Otherwise, you will receive an error message.

17. When the meter is ready for the sample, gently swirl the control bottle once or twice to mix the control solution. DO NOT mix the solution with the dropper.

18. Draw control solution into the dropper and put one drop of the liquid on the top of the target area (clear area of the test strip). DO NOT add more control.

DO NOT touch or remove the test strip while the test is in progress.

19. The flashing dropper symbol changes to an hourglass symbol when the meter detects a sufficient sample. You hear a beep tone when you have applied enough control solution (provided the beeper is turned on). The dropper symbol disappears and the test starts.

20. You must WAIT for results—this takes about one minute.

21. The result of the quality control is displayed. It is automatically saved to memory.

22. The acceptable range of results for the liquid control is displayed below the current result.

23. If any control remains in the dropper after you dose the test strip, return the remaining control material to the control bottle. Save extra control until after the test result is obtained, in case the control test needs to be repeated.

24. After you verify the validity of the control result, discard the test strip, dropper and the reconstituted bottle of quality control.

25. The control result is downloaded and saved in the RALS IMS.

26. The lockout feature on the meter will not allow patient testing unless QC is performed at least every 24 hours and passes.

27. If the quality control test fails, an up arrow (too high) or down arrow (too low) flashes on the display.

28. Report any problems with QC to the Ancillary Testing Coordinator.

29. If you need to repeat a test, use a new test strip.

30. Remove the quality control code chip and store it with the opened box of controls. Re-insert the test strip code chip if necessary.

31. Turn the meter OFF.

Limitations of the Method

The following are limitations of the CoaguChek XS Plus System.

LIMITATIONS

• The CoaguChek XS Plus System should not be used for patients being treated with Hirudin.

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• The CoaguChek XS PT Test uses only fresh capillary or non-anticoagulated venous whole blood. Plasma or serum cannot be used

• Use only plastic syringes without anticoagulants or additives. Glass tubes or syringes must not be used.

• The blood drop must be a minimum of 10 μL in volume. Low sample volume will cause an error message.

• Never add more blood to test strip after test has begun or perform another test using the same fingerstick

• When a patient is on intravenous infusion therapy, do not collect sample from arm receiving the infusion line.

• Hematocrit ranges between 25-55% do not significantly affect test results.

• Testing performed with the following in vitro spiked samples or native blood samples

(Triglycerides) indicated no significant effect on test results:

• Bilirubin up to 30 mg/dL

• Lipemic samples containing up to 500 mg/dL of triglycerides

• Hemolysis up to 1000 mg/dL

• The results are unaffected by heparin concentrations up to 0.8

U/mL.

• The CoaguChek XS PT Test is insensitive to low molecular weight heparins (LMWH) up to 2 IU anti-factor Xa activity/mL.

• Clopidogrel up to 20 mg/dL

• Fondaparinux up to 5 mg/L

• The presence of anti-phospholipid antibodies (APAs) such as Lupus antibodies (LA) can potentially lead to prolonged clotting times, i.e., elevated INR values. A comparison to an APA-insensitive laboratory method is recommended if the presence of APAs is known or suspected.3

• In rare cases, patients with long clotting times (>8 INR) may receive an “ERROR 7” message on the meter display. If this error message appears again when the test is repeated, the result must be checked using another method.

Cleaning the Meter

The following policies and procedures provide instructions for cleaning and disinfecting the CoaguChek XS Plus meter.

PROCEDURES

Cleaning / Disinfecting the Meter Housing

1. Gloves must be worn when performing any cleaning/disinfecting procedure and disposed of according to medical center infection control policies.

2. Use only the following items for cleaning/disinfecting the CoaguChek XS or CoaguChek XS Plus meter housing for a contact time of > 1 minute:

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a. 70% isopropyl alcohol

b. Super Sani-Cloth Germicidal Disposable Wipes

c. NOTE: Do not use any other disinfectants/cleaning solutions on the meter housing.

d. Do not use 91% alcohol on the meter housing.

3. Ensure that the blue meter test strip guide cover remains tightly closed while cleaning the housing.

4. Wipe the meter housing thoroughly while avoiding the meter test strip guide

(measurement chamber).

5. Let the disinfectant/cleaning solution sit on the meter for at least one minute.

6. Make sure that no liquid enters the meter or accumulates near any opening.

7. Wipe away residual moisture and fluids after cleaning the housing.

8. Allow wiped areas to dry for at least 15 minutes before performing a test.

Cleaning the Meter Test Strip Guide (Measurement Chamber)

1. Gloves should be worn when performing any cleaning/disinfecting procedure and disposed of according to medical center infection control policies.

a. Use 70% isopropyl alcohol.

b. Use Super Sani-Cloth Germicidal Disposable Wipes

c. Do not use any other cleaning solutions on the test strip guide. Use of other cleaning solutions could result in damage to the meter.

2. Remove the test strip guide cover.

3. Hold the meter upright with the test strip guide facing down (see picture below). This will help prevent fluid from entering the meter.

4. There are different types of isopropyl alcohol. Please note that only 91% isopropyl alcohol or 99% isopropyl alcohol can be used on the test strip guide. Any other isopropyl alcohol cannot be used on the test strip guide without risk to the meter.

5. Ensure the swab is only damp, not wet.

6. Wipe the test strip guide area.

7. Let the cleaning solution sit for at least one minute.

8. Wipe away residual moisture and fluids.

Reference

Roche CoaguChek XS Plus System Policy and Procedure Manual, 2009

PROCEDURE—Interpreting Test Result