Applicable To NOTE: CAPILLARY PUNCTURE-DO NOT WIPE AWAY THE FIRST DROP OF BLOOD.

Transcription

1 Subject PT-INR Whole Blood using CoaguChek XS Plus or Pro Test System Index Number Lab-1017 Section Laboratory Subsection Point of Care Testing Category Departmental Contact Rachel Blum Last Revised 9/26/2017 References Required document for Laboratory Accreditation by the College of American Pathologists (CAP, Centers for Medicare and Medicaid Services (CMS) and/or COLA. All certified CoaguChek operators. Applicable To Detail PRINCIPLE: The CoaguChek PT/INR test is an electrochemical measurement of prothrombin time following activation of blood coagulation with human recombinant thromboplastin. The elapsed time to clot detection is measured in seconds and reported as INR and/or seconds. All training and competency assessment is conducted in accordance with Lab-0955 Point of Care Testing General Policy/Quality Assurance described specifically under Testing Personnel. CLINICAL SIGNIFICANCE: The CoaguChek XS Plus or Pro Test System is an in vitro diagnostic test intended for quantitative prothrombin testing for the monitoring of oral anticoagulation therapy (Coumadin) using fresh whole capillary or non-anticoagulant venous blood samples. SPECIMEN: Capillary Option: 8 µl first drop capillary whole blood applied directly to the CoaguChek XS PT Test strip from the puncture site of the fingertip. Venous Option: 8 µl non-anticoagulant venous whole blood applied directly to the CoaguChek XS PT Test strip from a plastic syringe. It is important to waste the first four drops of blood from the syringe and dose the fifth drop onto the test strip. Specimen Identification: The certified operator identifies each patient through verbal identification of the patient s name and birth date. Refer to Lab-1330 Patient Identification for procedural guidelines. Specimen Collection: All samples are collected by skin puncture following standard precautions outlined in Lab-0105 Safety: Biological. Refer to Lab-1236 Skin Puncture for collection tips. NOTE: CAPILLARY PUNCTURE-DO NOT WIPE AWAY THE FIRST DROP OF BLOOD. Lab-1017 PT-INR Whole Blood using CoaguChek XS Plus or Pro Test System Page 1 of 10

2 Tips for producing a good drop of blood from capillary puncture: 1. Warm the hand by having the patient hold it under his/her arm, use a warm compress or hand warmer, and/or wash the patient s hand with warm water. 2. Massage the finger from its base. 3. Utilize a dependent arm position so that gravity increases the blood flow into the hand. 4. Gently squeeze the finger from its base to encourage blood flow. Stability: Non-anticoagulant whole blood must be applied to the test strip within 15 seconds of lancing or within 10 seconds after dispensing four drops of blood from the syringe. Unacceptable Specimens: 1. Specimens not immediately applied to the test strip in the time parameters outline above in Specimen Collection. 2. Blood samples containing anticoagulants clot activators or serum separators. 3. Blood samples drawn in glass syringes or glass tubes. 4. Plasma or serum CANNOT be used as a testing sample. 5. Sample size CANNOT be less than 8 µl. Low sample volume will cause an error message. 6. Additional blood CANNOT be added to the test strip once testing has begun or perform another test using the same fingerstick. 7. Samples CANNOT be collected from the arm receiving infusion during IV therapy. 8. NOTE: If a repeat test is required from the same patient to confirm or eliminate a testing error, then a fresh sample from a different hand or puncture site is obtained. REAGENTS /MATERIALS: CoaguChek XS PT Test strips, Roche Diagnostics: Store the test strips in the original container, with the cap tightly closed at room temperature or in the refrigerator (2-30 C or F). Properly stored strips are stable until the manufacturer expiration date printed on the test strip container. A lot specific code chip is included in each box. Test strips that exceed the expiration date are discarded. Use the strip within 10 minutes after removing it from the vial. Do not open a vial of strips or touch them with wet hands or gloves. CoaguChek XS Pro PT Controls, Roche Diagnostics: Store the controls at 2-8 C (36-46 F). DO NOT FREEZE. Unopened, lyophilized controls that are properly stored are stable until the manufacturer expiration date printed on the package/vial. Controls are stable for 30 minutes after adding the diluent. Lot specific code chip included in each box. Controls that exceed the expiration date are discarded. Other materials needed (Supply items): 1. Alcohol Wipes 2. 2 x 2 gauze pads 3. Disposable vinyl gloves 4. Plastic syringe for venous collection EQUIPMENT/INSTRUMENTATION: Lab-1017 PT-INR Whole Blood using CoaguChek XS Plus or Pro Test System Page 2 of 10

3 Roche CoaguChek XS Pro (moderate complexity testing) or Roche CoaguChek XS Plus (waived complexity testing), Roche Diagnostics: Includes Coaguchek hand-held meter and Docking/Charging Station. Accu-Chek Safe-T-Pro Plus, Single-use, Auto-disabling, Adjustable depth 1.3 mm, 1.8 mm, 2.3 mm lancet, Roche Diagnostics. 200 lancet/box. (Supply item). Lithium Polymer Battery, Rechargeable Power Pack, Roche Diagnostics. Calibration/Calibration Verification: Each lot of test strips is calibrated to a reference lot that is traceable to the WHO International Reference Preparations. Roche Diagnostics tests each strip lot to ensure that calibration data provides analytical values that correspond to established reference methods. Each strip code chip supplied with each box of test strips automatically calibrates the meter for that particular lot of strips. The test strip lot # code must match the code chip lot # inserted/selected in the meter, or the test will not run. For the purpose of providing universal INR results, the Mean Normal Prothrombin Time (MNPT) has been established as 12 seconds for healthy volunteers and the International Sensitivity Index (ISI) for the CoaguChek XS system has been established as 1.0. The CoaguChek XS Pro/Plus System cannot be adjusted externally to fit a certain linearity curve. QUALITY CONTROL: The CoaguChek XS Pro/Plus Quality Control program is designed to monitor performance of both the meter and reagent test strips using a mixture of internal and external quality control components. Internal Quality Control: The CoaguChek XS system performs many types of quality control tests independently: 1. A check of the electronic components and functions every time the meter is turned on. 2. A check of the expiration date and lot information on the test strip. 3. A quality control function is incorporated into the test strip using a two-level, on-board reagent quality control and patient result determination within a single test chamber. 4. If the on-board reagent quality control fails, an error code displays and the patient test is aborted. External (Liquid) QC Frequency: 1. Liquid quality control samples are scheduled within the RALS connectivity program and required to be tested on the first working day of the month. QC Lockout appears on the meter screen. Patient testing is not an option until two levels of quality control are tested and PASS. 2. Liquid quality control is automatically forced with each new lot # of test strips when steps are followed for coding the meter with the strip code chip. Each time a new box of test strips is opened, the code chip inside is placed into the meter (marked S_xxx). The meter will recognize the new and different strip code chip and automatically require successful liquid quality control before patient testing can resume. Liquid Quality Control: Each CoaguChek XS Pro PT control package contains four vials Level 1 lyophilized control, four vials lyophilized Level 2, eight universal diluent droppers (containing calcium chloride reagent) and one control code chip (marked C_xxx). The control range for each level is programmed into the control code chip and is downloaded into the meter via the RALS data management system. Lab-1017 PT-INR Whole Blood using CoaguChek XS Plus or Pro Test System Page 3 of 10

4 STEPWISE INSTRUCTIONS: Preparing the controls: 1. Remove a set of control vials (Level 1 and Level 2) and two diluent droppers from the refrigerator. No warm up is necessary prior to dilution. 2. Remove the black screw top and rubber stopper from each QC vial. 3. Grasping the diluent dropper by the narrow stem and holding the dropper bulb-end downward, snip the end of the stem with scissors. DO NOT squeeze the bulb of the pipet while cutting the tip. 4. Invert the diluent pipet and place the pipet stem into the QC vial. Squeeze the bulb to dispense all the contents of the dropper over the dried material. 5. Remove the dropper from the bottle. Do not discard the dropper. Replace the cap and gently swirl the bottle to dissolve the dried material. Do not shake or invert the vial. Let the bottle sit undisturbed for at least one minute to ensure that the dried material completely dissolves. 6. Repeat the process with the second control vial. 7. The reconstituted control solution must be used within 30 minutes. Label the bottle with the time reconstituted and discard it when expired. Performing the quality control test: 1. Place the meter on a flat, vibration-free surface. Turn the meter ON by holding the power button for one second. 2. Login into the CoaguChek by entering your six-digit employee number as your operator ID. CoaguChek Pro=Scan barcode parallel to black strip on the back of your name badge. No password is required when barcode is scanned. CoaguChek PLUS or PRO meter when barcoded name badge is not available or scanning is not an option - From the screen s pick list, touch your six-digit employee number and enter the last four numbers of your social security number as your password. 3. From Main Menu, press CONTROL TEST. 4. The Insert Test Strip icon appears on the meter screen. Remove one strip from the vial and immediately recap to maintain correct strip reactivity. Hold the strip lettering side upward and slide it into the strip guide in the direction indicated by the arrows. 5. Select the QC lot # on the screen that matches the lot # on the control vial. If prompted, insert the control chip into the meter. Select Level The hourglass icon shows that the meter is warming the reagent inside the strip, which takes about 30 seconds. When the warming process is complete, an audible beep is heard. At the same time, the meter begins a 180-second countdown and the dropper icon appears when ready for control sample. 7. Gently swirl the control vial twice. DO NOT mix the solution with the dropper. Using the dropper saved during control preparation, draw Level 1 control solution into the dropper. Apply a single drop of control from the dropper to the application area on the top of the strip. DO NOT add more control and DO NOT touch or remove the strip while the test is in progress. 8. When the meter detects enough sample, the dropper icon disappears, an hourglass symbol appears, and an audible beep is heard as the test starts. 9. Level 1 control result displays. The acceptable range for the level of QC is displayed below the current result and flagged as PASS or FAIL. If the QC PASSES, proceed to Step 10. If the QC result fails, an up or down arrow displays and flashes. If QC FAILS, repeat the test using the same control solution (if less than 30 minutes old) and a new test strip. Lab-1017 PT-INR Whole Blood using CoaguChek XS Plus or Pro Test System Page 4 of 10

5 10. Touch the comment icon to add pre-defined comments as indicated (QC Passed, QC Failed- Repeat, Cleaned Meter, and Operator Training). Do not enter custom comments. Touch the green check mark to return to the result screen. Review the comments. If correct, touch the menu button. Follow the meter prompts to Remove Test Strip when the icon appears. 11. Dispose of the used test strip in the regular trash and the control vials in the biohazard container. 12. Repeat steps 3-11 for the next level. 13. Power the meter OFF by holding the power button for one second. 14. Clean/Disinfect the meter after use. Common Error Causing QC to Fail: 1. Incorrect QC used- The QC level selected on the meter differs from the QC solution actually applied to the test strip. 2. Failure to test the control vials within the thirty minute dilution time limit or failure to gently swirl the control vial contents to verify uniform re-suspension before testing. 3. Expired or improperly stored controls. 4. The test strip must be used within 10 minutes of removing the test strip from its container. Required Frequency of Use: Lab staff/department point of care testing staff verify each new lot number of PT Test strips using Level 1 and Level 2 QC samples prior to patient testing. Also, QC is tested the first working day each month. A programming feature in RALS locks the meter on the first day of the month until QC passes. Acceptable Tolerance Limits: Guidelines for strips performance acceptability and rejection are outlined in Lab-0955 Point of Care Test- General Policy including Quality Assurance Guidelines. When multiple CoaguChek XS PRO meters are used within one lab location, QC results are used to monitor instrument performance and test agreement between these meters. For CoaguChek PT-INR, the acceptable limits are defined as Level 1 +/- 0.1 and Level 2 +/-0.3. If limits of acceptability are exceeded following one repeat attempt, then corrective action is initiated to include but not limited to normal instrument maintenance or precision testing. Document QC agreement once each month through the use of these pre-built comments: 1. All L1 within All L2 within L1-L2 Correct. Act. Corrective Action: If quality control tests fall within the stated control ranges, patient testing may continue. However, if quality control tests fall outside the acceptable ranges, the problems must be corrected before proceeding with patient testing. Refer to the trouble shooting section of the CoaguChek XS Plus/Pro Operator s Manual for a quick reference to possible solutions. Call Point of Care staff at (pager# 0080), Regional Lab Supervisor La Crosse or your local Regional Affiliate Hospital Lab Manager for help with unresolved problems or for help to obtain a loaner CoaguChek meter. Recording QC Data: Lab-1017 PT-INR Whole Blood using CoaguChek XS Plus or Pro Test System Page 5 of 10

6 External Liquid QC results are recorded within the RALS data management system. The Regional Supervisor/ Regional Affiliate Lab Manager, Point of Care Coordinator and/or designee review the quality control monthly for completion and testing problems. The data is reviewed and translated into an electronically signed report. Depending on the testing site, the report is either stored with RALS data management system or printed and sent to the testing site for storage. CoaguChek Cleaning and Disinfecting: The CoaguChek is cleaned and disinfected after every patient test by using one or more hospitalapproved wipes. Currently, our disinfection products include Hydrogen Peroxide Wipe (Oxivir-Routine Use) or Bleach Germicidal Wipe (Clorox-Isolation Room Contact Precautions-Identified to kill c. difficle). The exterior housing of the meter is gently disinfected after each patient use. The cleaning-disinfection frequency is established following FDA, CDC, MC and the Gundersen Health System Infection Control Department guidelines. Meter Housing Cleaning-Disinfection Procedure: 1. Power the meter OFF. Ensure that the blue test strip guide cover remains tightly closed while cleaning the meter housing. Don a clean pair of gloves. 2. Remove a hospital-approved wipe from its container, blotting/squeezing the excess moisture from the wipe. 3. If visibly soiled, pre-clean the housing of the meter with and an approved wipe before completing disinfection, step If the CoaguChek is not visibly soiled, disinfect the housing of the meter with an approved wipe. 5. Allow the surface to air dry for the maximum disinfection effect (minimum contact time is one minute). 6. Cleaning-Disinfection is documented during each patient test using the pre-built comment Cleaned Meter. Test Strip Guide Cleaning-Disinfection Procedure (Required once each day): 1. Remove the blue test strip guide cover from the CoaguChek meter, best accomplished by placing your fingertip into the test strip guide opening and pressing upward. 2. Once removed, rinse the cover with warm water or wipe it clean wipe an alcohol wipe. 3. Clean the exposed white square area of the meter with an alcohol wipe or alcohol- moistened cotton swab. 4. Allow the test strip guide cover and the white area of the meter to air dry for 10 minutes before reassembling the meter. The blue test strip guide snaps into place when properly attached. 5. CAUTION: DO NOT let liquid accumulate near any opening. ENSURE that no liquid enter the meter during the cleaning-disinfection process. 6. Test Strip Guide Cleaning-Disinfection is documented on the lab s daily checklist in the place provided or by adding the Clean Blue 1x Daily pre-built comment in CoaguChek meter with the first patient test each day. Proficiency Testing: Roche CoaguChek XS Pro moderate complexity testing locations are enrolled in an approved proficiency testing program. The lab director or designee reviews results. Lab-0135 Quality Assurance for Laboratory testing is initiated for corrective action if results exceed tolerance limits. Lab-1017 PT-INR Whole Blood using CoaguChek XS Plus or Pro Test System Page 6 of 10

7 Implementation PATIENT TEST PROCEDURE: 1. Place the meter on a flat, vibration-free surface. Power the meter ON by holding the power button for one second. 2. Login into the CoaguChek by entering your six-digit employee number as your operator ID. CoaguChek Pro- Scan barcode parallel to black strip on the back of your name badge. No password is required when barcode is scanned. CoaguChek PLUS or PRO meter when barcoded name badge is not available - From the screen s pick list, touch your six-digit employee number and enter the last four numbers of your social security number as your password. 3. From Main Menu, press PATIENT TEST. 4. Scan or Enter Patient ID. Regional Lab and Affiliate Locations-The patient's ID consist of utilizing Beaker's test specific MPI barcode printed by the phlebotomist directly from the provider's order during the collection process. CoaguChek PRO- Press and hold the scan button, passing the red laser light over the test specific printed MPI barcode. The screen automatically advances. CoaguChek Plus- Enter the eight-digit MPI number as the patient ID as it appears on the test specific label that prints when the order is collected. Double check the number entered before touching the green check mark to move to the next screen. 5. The test strip icon prompts you to insert a test strip. Remove a strip from the vial and replace the cap immediately. Holding the test strip so that the lettering is facing upward, slide it into the blue test strip guide in the direction indicated by the arrows and into the meter as far as it will go. An audible beep it heard. 6. The hourglass icon appears as the test strip warms. An audible beep indicates when the warming step is finished. The icon changes to a flashing blood drop icon when the meter is ready for the patient s blood sample. A 180 second countdown begins. A drop of patient blood must be applied before the countdown ends, otherwise an error message will display. 7. Obtain a capillary or venous whole blood non-anticoagulant sample within 180 seconds. Capillary Technique: a. Using the Safe-T-Pro Plus lancet, puncture the side of a warm, alcohol or soap/ water cleansed and dried fingertip. b. Massage the fingertip until a lady-bug sized drop forms. Actual sample size is about 8 µl. c. DO NOT WIPE AWAY THE FIRST DROP OF BLOOD. d. Apply the first drop of blood to the top or side of the application area of the test strip. e. Hold the blood drop to the test strip until the flashing drop icon disappears and the meter beeps. f. The audible beep indicates that enough blood entered the test strip to begin the test. g. NOTE: Apply the blood drop to the top or side of the application area on the test strip within 15 seconds of the fingertip puncture. Venous technique: a. Collect venous blood in only a plastic syringe. b. Expel the first four drops from the syringe and apply the fifth drop of blood to the top of the application area of the test strip. c. The flashing drop icon disappears and the meter beeps. Lab-1017 PT-INR Whole Blood using CoaguChek XS Plus or Pro Test System Page 7 of 10

8 d. The audible beep indicates that enough blood entered the test strip to begin the test. e. NOTE: After the first four drops are expelled, blood must be applied from the syringe to the top or side of the application area on the test strip within 10 seconds. 8. An hourglass icon appears as the assay begins. The meter performs an automatic quality control test on the strip s reagent before it displays the test result. QC appears briefly on the screen. If the internal QC is successful, then a green check mark appears after QC. If the internal QC fails, then an error message appears and the patient test is aborted. 9. The meter displays both the patient s calculated INR result and prothrombin time in seconds. Only the INR result is sent to the patient s electronic medical record. 10. Measurement Result OK? Select Accept or Reject. Pre-Built comments are required for both responses. If a result is rejected, the test result is no longer displayed but stored in the database. 11. Touch the Comment Bubble icon to enter up to three pre-built comments that indicate: a. Chart or Do Not Chart b. Cleaned Meter c. Notification Comments (RN or Provider Notified) for critical range INR results. The comments selected can prevent a result from automatically charting/charging, documents disinfection steps, and prompts the user toward the first step in recognition of critical range result and notification actions that must follow. Once you have selected the desired comment(s), touch the green checkmark to return to the results screen. 12. Press the Main Menu button. You will be prompted to remove the strip and dispose of the test strip into the regular trash. 13. Power the meter off to complete disinfection steps. 14. IMPORTANT FIRST STEP for REGIONAL LABS and AFFILIATE LOCATIONS: Always complete collection by receiving the order in LIS Beaker. Dock the meter to initiate data transfer into the RALS data management system and into the electronic medical record/anticoagulation management program. Manual data entry is an option for only delayed or failed electronic result transfer. NOTE: Dock the CoaguChek meter only after receiving the order in LIS! This is a sequential process that hinges on the reception of the received order in RALS prior to docking the meter. CALCULATIONS: The PT/INR assay reports results as International Normalized Ratio (INR) values. The CoaguChek XS Plus or Pro meter contains a microprocessor that performs all calculations required for reporting. All INR result calculations are based on the following equation: INR = Patient prothrombin time (sec) ISI Mean Normal prothrombin time (Sec) INTERPRETATION: Normal Range INR = Critical Call Result: > 5.0 INR Therapeutic Range = INR Mechanical Heart Valve Range = INR Lab-1017 PT-INR Whole Blood using CoaguChek XS Plus or Pro Test System Page 8 of 10

9 Current CoaguChek Reportable Range: INR Test comment added to all PT-INR results via LIS states: "Note: Coagulation specimens from patients with a hematocrit of 55% or greater 55 must be volume reduced at the time of collection to avoid erroneous results. If your patient meets this criterion, please call the site specific lab at site number to arrange volume reduced specimen collection." Results that exceed the reportable range of the analyzer are marked with greater than (<) or less than (>) signs. All whole blood sample INR results > 8.0 or < 0.8 are reported electronically in LIS Beaker as displayed on the CoaguChek screen. NOTE: The CoaguCheck sends the >8.0 result when the INR exceeds the reportable range and this result is chartable. INR results >8.0 should be confirmed with a venous blue top specimen sent to a core lab on a new, separate INR order. The core lab confirmatory INR test charge is canceled. Special Notes: 1. Results exhibiting inconsistency with the patient s clinical status should be confirmed by repeat analysis or supplemented with additional venous testing. 2. Critical range INR results greater than 5.0 require provider notification. Once the CoaguChek is docked, the INR critical range result travels through RALS and falls onto the lab s Outstanding List in Beaker. The lab staff must notify the provider, document all actions in the Communication Log, and release the hold before the INR result can be Final Verified and sent into the patient s EMR. 3. If you must repeat a test, use a new lancet to make a new puncture on a different fingertip. 4. Any INR result displayed with a flashing "C" message is not valid! The flashing "C" indicates that the patient's hematocrit may be too low to run the test, or it may indicate that the whole blood sample was compromised during the collection process. Repeat the test only one time, ensuring that proper techniques were followed. If the flashing "C" error occurs a second time, collect a venous sample and send to a core lab for testing. (See example below) **NOTE: Any error message is not regarded or interpreted as a valid INR result. In these cases, draw a venous blue top INR and send the sample to a core lab for testing. Contact your Regional Lab Supervisor, Regional Affiliate Hospital Lab Manager or La Crosse Lab POC staff at ext or pager #0080 for troubleshooting assistance. LIMITATIONS: Factor Affecting Results/ Interfering Substances: Lab-1017 PT-INR Whole Blood using CoaguChek XS Plus or Pro Test System Page 9 of 10

10 1. The analyzer must remain on a level, vibration free surface with the display facing up during testing. 2. Glass syringes or tubes may prematurely activate coagulation, resulting in accelerated clotting times and lower INRs. Venous samples must be collected into plastic syringes or tubes. 3. Hematocrit ranges between % do not significantly affect test results. 4. The CoaguChek XS System should not be used for patients being treated with an direct thrombin inhibitors, including Hirudin, Lepirudin, Bivalirudin, and Argatroban. 5. The CoaguChek XS INR assay is not affected by the following: a. Bilirubin up to 30 mg/dl b. Lipemic samples containing up to 500 mg/dl triglycerides c. Hemolysis up to 1000 mg/dl d. Heparin concentrations up to 0.8 U/mL e. Low molecular weight heparin (LMWH) up to 2 IU anti-factor Xa activity/ml f. Clopidogrel up to 20 mg/dl g. Fondaparinux up to 5 mg/l 6. The presence of anti-phospholipid antibodies such as lupus antibodies can potentially lead to prolonged clotting times, elevated INR values. If the presence of lupus anticoagulant antibodies is known or suspected, consider using a prothrombin time laboratory assay using a reagent that is known to be insensitive to lupus anticoagulant antibodies or an alternate laboratory method. 7. PT/INR results may be affected by commonly administered drugs. 8. The presence of exogenously added heparin, citrate, oxalate, or EDTA from blood collection devices will interfere with INR test results. REVIEW AND CHANGES: This document and all attached forms should be reviewed optimally on an annual basis, with 2 years as the maximum review date. Review will be done by the supervisor, manager, technical leader, medical director or designated person. Changes require retyping document or form and review by the medical director. REFERENCES: 1. CoaguChek XS PT Test Strip, Product Insert, Roche Diagnostics, CoaguChek XS Pro PT Controls, Product Insert, Roche Diagnostics, CoaguCheck XS Plus Operator s Manual, Roche Diagnostics, CoaguChek XS Pro Operator s Manual, Roche Diagnostics, CoaguCheck XS Pro System, Policy and Procedure Manual CD, Ref rev 02, Roche Diagnostics, Lab-1017 PT-INR Whole Blood using CoaguChek XS Plus or Pro Test System Page 10 of 10