CoaguChek XS Plus System Whole Blood Protime/INR

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2 CoaguChek XS Plus System Whole Blood Protime/INR A. PURPOSE The CoaguChek XS System is intended for use by professional healthcare providers for quantitative protime testing (PT) and calculated INR for monitoring Warfarin therapy. Results are considered definitive for patient care and diagnosis. This CLIA waived system for point of care testing allows for immediate results and subsequent timely patient education throughout the Bassett Healthcare Network. B. PRINCIPLE OF OPERATION The CoaguChek XS Plus PT Test will provide an electrochemical measurement of prothrombin time following activation of blood coagulation with human recombinant thromboplastin. Blood interacts with the chemicals in the test strip to make a small electric current in the test strip that measures blood-clotting time. The INR is calculated based on ISI of the thromboplastin in the test strip. C. SPECIMEN REQUIREMENTS 1. Sample type: CoaguChek XS Plus PT tests may be performed with fresh capillary whole blood from a fingerstick or fresh venous whole blood drawn in a nonanticoagulant plastic syringe. Sample Size: Minimum sample size is 20 µl of blood. 2. Procedure for Capillary Sample Collection Seat the patient comfortably a) Warm the hand with a hand warmer or warm water. b) Have the patient let their arm hang down by their side. c) Massage the finger from its base. Clean the selected area with rubbing alcohol. Allow the puncture site to air dry. Prepare lancet (depth adjust if needed). Prepare the Capillary Blood Collection System if needed by firmly inserting the capillary tube into the bulb. Lance the fingertip. Use the side of the fingertip and massage the lanced finger until a drop of blood is formed. Gently squeeze the finger until a ladybug size of hanging blood forms. If using the Capillary Blood Collection System, collect the sample into the capillary tube by holding the tube horizontal to the drop. Fill tube with 2-3 drops. Cover the opening of the bulb. Gently squeeze the bulb with your hand to dispense the sample on the test strip. 3. Procedure for venous sample collection: For sample collection use a standard blood collection device. Do not use anti-coagulants (e.g. EDTA, citrate, fluoride, oxalate, or heparin) to collect the blood sample. Venous blood samples may be collected from a venous line, after an appropriate line volume is discarded. Collect into a nonanticoagulated syringe, 2

3 If venous samples are collected by venipuncture, note the following: a) Use a needle at least 23 G (approx mm) or larger in size. b) Discard the first four drops of blood collected (within the first 10 seconds). Then immediately apply one drop of blood (at least 8 µl) directly onto the target area of the test strip. Ensure that no air bubbles are introduced into the sample. Unacceptable Specimens Plasma or serum CANNOT be used as a testing sample. Sample size CANNOT be less than 10 µl Venous sample CANNOT be collected in a syringe containing anticoagulant, Sample must be USED IMMEDIATELY after collection. Glass tubes or glass syringes CANNOT be used (only use plastic). D. REAGENTS/MATERIALS/INSTRUMENTATION 1. Materials a) Roche Diagnostics CoaguChek XS Plus meter. Store and use meter between 15 and 32 C and 10 to 85% humidity. 3

4 b) CoaguChek XS test strips and code chip (Cat. No ) - Warehouse # c) CoaguChek XS Pro PT Controls (Cat No ). Store controls at 2 to 8 C until the expiration date. DO NOT FREEZE. Obtain from Point of Care. d) CoaguChek XS Systems Capillary Blood Collection Systems (Cat No. # ). Obtain from Point of Care. e) AccuChek safe T-Pro plus lancet single use disposable (Roche) Warehouse # f) Alcohol swab g) Gauze or cotton ball h) Clorox germicidal wipes EPA# req no i) 70% alcohol i) Scissors 2. Storage and Handling a) CoaguChek PT test strips Store CoaguChek XS test strips in their original vial tightly capped at room temperature (18-32 C) until ready to use. b) When stored at the recommended room temperature, test strips are stable until the expiration date that is printed on the vial. c) The test strip must be used within 10 minutes once removed from the vial. Recap vial immediately after opening. d) Do not handle CoaguChek XS PT test strips with damp or moist hands. E. QUALITY CONTROL REQUIREMENTS Built in Quality Control A check of the electronic components and functions every time the meter is turned on. A check of the test strip temperature while a test is in progress. A check of the expiration date and lot information on the test strip carried out by the code chip. A two-level, on-board quality control test and patient result determination within a single test chamber. Liquid Quality Control Level 1 and Level 2 CoaguChek XS Pro PT Controls. Frequency Level 1 and Level 2 with each new lot reagent strips prior to patient testing. Level 1 and Level 2 each month for each lot number of reagent strips in use. QC is rotated among operators and locations. F. PROCEDURE 1. Quality Control a) Insert the Quality Control code chip into the meter. This tells the meter the acceptable ranges for this box of controls. b) Remove the QC vials from refrigeration, they can be reconstituted immediately. 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

5 c) 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. d) Invert the dropper and place the tip into the bottle. Be careful to avoid losing any diluent. e) 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. f) Remove the dropper from the bottle. Do not discard the dropper. Replace the cap first and gently swirl the bottle to dissolve the dried material. Do not shake or invert the bottle. Let the bottle sit undisturbed for at least a minute to ensure that the dried material dissolves completely. Use the reconstituted quality control solution within 30 minutes from the time the diluent is added. 2. Performing the Test a) When you are ready to test, remove 1 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 wet gloves. This may damage the test strips. You must 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. b) Insert test strip as far as you can into the meter. This powers the meter ON. c) Press QC TEST. The meter warms the test strip for about 30 seconds. Then the meter begins a countdown. You have 180 seconds to apply a liquid quality control solution to the test strip. d) 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. If you are using test strips from a new, unopened container, you will need to change the test strip code chip. e) 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. Draw control solution into the dropper and put one drop of the liquid on top of the target area (clear area of the test strip). Do not add more control. f) Do not touch or remove the test strip while the test is in progress. The flashing dropper symbol changes to an hourglass symbol when the meter detects sufficient sample. If the meter's beeper is enabled, a beep sounds as well. 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. The result appears in approximately one minute. g) Record the result on the CoaguChek XS Plus QC Log. After you verify the validity of the control result, discard the test strip, dropper and the reconstituted bottle of quality control solution. h) Remove the Quality Control code chip and store it with the opened box of controls. Re-insert the test strip code chip. i) Power the meter OFF. 5

6 j) Retrieve QC test information by selecting REVIEW RESULTS, QC RESULT. The meter stores 500 patient results, the most recent is displayed first. NOTE: If you need to repeat a test, use a new test strip. Expected results The meter displays the acceptable control range and the result. The reading is automatically saved in the memory of the meter. The system is working properly and all handling has been done correctly when the test results obtained are within the acceptable control range. Unacceptable results Repeat the sample within 30 minutes of reconstitution. Contact Point of Care for technical assistance. 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. Coding the Meter: A code chip is included with each new container of test strips. Use the code chip only with the tests in that container. Each code chip is specific to a particular lot of test strips. The code chip contains programming information about the test type, lot number, expiration date, and function curve. The code chip must not be exposed to moisture or devices that produce magnetic fields. A new code chip is inserted into the CoaguChek XS Plus monitor each time a new vial of strips is opened. The code chip remains in the monitor until the lot of test strips in use is changed. The old code chip is then discarded. The meter can store information for 60 code chips. Turn off monitor before inserting or removing code chip. Remove old code chip, if one is installed, and discard. Insert new code chip with code number facing up until it snaps into place. Turn monitor on. New information is then programmed into the monitor from the code chip. Meter is ready for patient testing. Patient Test Check the meter for the correct lot code chip. Place meter on a flat surface. Turn the meter on by pressing the On/Off Button and holding until the meter turns on. Check the battery level. If there are no bars left in the battery symbol, you cannot perform anymore tests. Check that the date and time are correct. Take a test strip out of the container. Close the container tightly. Do not touch a test strip with wet hands or gloves. This may damage the test strips. Use the test strips within 10 minutes. Enter operator ID (operator bar code number if available). Touch ( ) OK to log on. Select PATIENT TEST. Enter Patient ID, using the visit number. The test strip symbol prompts you to insert a test strip. Hold the test strip so the lettering CoaguChek XS PT is facing upward. 6

7 Slide the test strip into the test strip guide in the direction indicated by the arrows. Slide the test strip in as far as it will go. Listen for a beep. An hourglass symbol shows that the test strip is pre-warming. At the completion of the pre-warming period you hear a beep tone. You will see an icon of a falling drop of blood and a 180 second countdown begins. DO NOT puncture finger until the flashing test strip and blood drop symbols appear on the meter screen. Perform the finger puncture, collect the blood using one of the methods as described in section C-Specimen Requirements. Apply the first drop of blood (8 µl) to the semicircular, transparent sample application area of the test strip. Dose the meter using top dosing or side dosing. Dose the meter within 15 seconds of the puncture. Hold the blood drop to the test strip until you hear a beep. The flashing blood drop symbol disappears. The sample must be delivered to the test strip all at once. Deliver the sample in a single drop for the instrument to test accurately without errors. The meter performs a two-level on-board quality control test on the test strip before it displays the test result. QC appears in the display. Following a successful outcome of the quality control test, a check mark appears after QC. The PT/INR results are displayed. The results are displayed in less than one minute. Record results in EPIC/Hemoglobin and PT/INR Patient Result Log or the downtime log. After the test and results are displayed touch the comment icon. It is recommended to document that the meter has been cleaned per policy after each patient use. To do so, select CLEANED METER comment. Select the MENU icon until the REMOVE menu will appear on the screen. Remove the test strip from the measurement chamber. When you are done testing, turn the meter off or allow it to time out (5 minutes). Clean the exterior of the meter with Clorox Germicidal wipes after each use. See cleaning and maintenance section J. Retrieve patient test information by selecting REVIEW RESULTS, PATIENT RESULT. The meter stores 2,000 patient results, the most recent is displayed first. G. REFERENCE RANGE CoaguChek XS Plus test results are displayed as PT in seconds and INR. The physician determines the best INR level for the patient depending on the reason for anticoagulant treatment and each individual s response to treatment (based on INR). Each physician should establish expected values for his or her patient. Normal Range INR PT seconds Therapeutic Range INR INR Routine Oral Anticoagulation Mechanical Valves 7

8 H. MEASURING RANGE Reportable Range INR PT seconds Results that are above or below the measuring range are indicated by the symbols > (above) or < (below). I. CRITICAL VALUE RANGE Critical Value INR >4.4 J. RESULT DOCUMENTATION - Test Order Code POC 115 a) PT/INR results are documented in the enter/edit function of Unity (EPIC). Report the PT seconds and the INR. Document the internal QC as acceptable. Complete all required fields with the RED STOP sign. b) Complete additional optional fields listed below with patient s responses. Some fields are free text and others have default answers. Warfarin/Coumadin/Jantoven Heparin/Low Molecular Weight Heparin Direct Acting Oral Anticoagulant Medication in dose mg Medication Frequency Bleeding Bruising Bleeding/Bruising Location New Medication Prescriptions/Instructions Missed Doses in Past Week 8

9 a,b. c. c) Inhibitor Comment Append POC INR result inhibitor comment under narrative tab for ALL results. d) INR results that are greater than 6.0 are reported in the comment section. Report PT as Cannot report seconds when INR > 6.0. Report INR as > 6.0. d. 9

10 e. e) Critical Values For INR results greater than 4.4, append your critical value called documentation under the narrative tab. Search for canned comment by typing POC in the smart text field. Select POC critical value. The following statement will appear (Provider *** notified of critical value and read back on *** at *** by ***). Use the F2 key to advance to each of the *** spaces and enter the appropriate information. f) Confirmation Samples INR values that are greater than 6.0 must be confirmed at the appropriate Bassett Network Lab (MIB, CRH, OCH, and TRH). A venous sample is collected for PT/INR. A Print Screen copy of the Unity documented 10

11 results is sent with the sample (see example). A provider order in Unity is not required. g) Downtime In the event of Unity or a network downtime, testing is ordered and results are documented on the Warfarin/anticoagulant record (H7349). This record is scanned into Unity for a permanent report. K. LIMITATIONS 1. Test result accompanied by C. This usually means one of three things: The patient has a hematocrit value right around or lower than the CoaguChek XS Plus system lower limit allowance of 25%. The patient s hands were not completely dry before the blood sample was taken. The patient s finger was excessively squeezed to obtain the sample, diluting the blood and resulting in a low hematocrit. Retest on a different finger, ensuring the patient s hands are both completely dry and the finger is not excessively squeezed after the finger stick. If you still get a C with the test result, we recommend you perform a hematocrit check on that patient and send a venous specimen to the lab to check the patient s PT/INR value, if you confirm their hematocrit is less than 25%. 2. Hematocrit ranges between 25-55% do not significantly affect test results. 3. Results with 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 Heparin concentrations up to 0.8 U/mL 11

12 Low molecular weight hepartins (LMWH) up to 2 IU anti-factor Xa activity/ml Clopidrogrel up to 20 mg/dl Fondaparinux up to 5 mg/l 4. The CoaguChek XS Plus System should not be used for patients being treated with any direct thrombin inhibitors including Hirudin, Lepirudin, Bivalirudin and Argatroban. 5. The presence of anti-phospholipid antibodies (APAs) such as Lupus antibodies (LA) can potentially lead to prolonged clotting times, i.e., elevated INR values. L. MAINTENANCE/CLEANING Document cleaning on the Point of Care Maintenance Record. 1. Cleaning/disinfecting the exterior Ensure that the blue test strip guide cover remains tightly closed while cleaning the meter housing. With the meter powered off, wipe the meter s exterior clean using Clorox Germicidal Wipes. Do not let liquid accumulate near any opening. Ensure that no liquid enters the meter. With a fresh dry cloth or lint free tissue, wipe away residual moisture and fluids after cleaning the housing. Allow wiped area to dry for at least 10 minutes before performing a test. 2. Cleaning/disinfecting the test strip guide - Recommended cleaning schedule: once per box of strips or as needed. Remove the test strip guide cover to clean it. (Use your thumbnail to open the cover of the test strip guide by pressing its front edge upward,) Move the cover safely away from the meter. Then rinse the cover with warm water or wipe it clean using the solutions recommended. Let the test strip guide cover dry for at least 10 minutes before reattaching it. Hold the meter upright with the test strip guide facing down. Clean the easily accessible white areas with a moistened cotton swab. Ensure the swab is only damp, not wet. Wipe away residual moisture and fluids. 3. Installing or replacing batteries page Operator s Manual M. TROUBLESHOOTING See pages Operator s Manual, call Point of Care x6728 or Technical Support N. REFERENCES 1. Roche Diagnostics Corporation Policy and Procedure 2. CoaguChek XS System Package inserts for Test Strips. 3. MIBH Laboratory Hematology Policy and Procedure for coagulation. 4. CoaguChek XS Plus Operator Manual, Roche. 12

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