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Bassett Medical Center The Mary Imogene Bassett Hospital Point of Care Title: CoagChek XS System Whole Blood Protime INR Revision: 9.01 Created By: Admin, The(Quality Manager) Last Approved Time: 5/14/2019 7:34:52 AM

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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

only. 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 non-

anticoagulant 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).

Using the ring finger or middle finger, lance the fingertip. Use the side of the fingertip, gently massage or squeeze the finger until a ladybug sized drop of

hanging blood forms.

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 non-

anticoagulated syringe,

If venous samples are collected by venipuncture, note the following:

a) Use a needle at least 23 G (approx. 0.65 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)

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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.

b) CoaguChek XS test strips and code chip (Cat. No. 04625315160) - Warehouse #896027 Note: Strip lots are automatically reported in the RALS System. Paper

documentation is not required.

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c) CoaguChek XS Pro PT Controls (Cat No. 04625382160). Store controls at 2

to 8°C until the expiration date. DO NOT FREEZE. Obtain from Point of Care.

d) AccuChek Safe T-Pro plus lancet – single use disposable (Roche) – Warehouse #400203

e) Alcohol swab

f) Gauze or cotton ball g) Clorox Germicidal Wipes – EPA# req no 67619-12; warehouse item 554713

h) 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. 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.

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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.

2. 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. 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.

g) When you are ready to test, remove one strip from the container and immediately close the container. The meter automatically checks for the

correct 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 the test strips are from a new, unopened container, the test strip code chip

will need to be changed. h) 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. i) Power the meter ON. Enter operator ID number.

j) Select QC TEST. The test strip symbol prompts you to insert a test strip. k) Hold the test strip so the lettering “CoaguChek XS PT” is facing upward. l) 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. m) An hourglass symbol shows that the test strip is pre-warming for about 30

seconds. At the completion of the pre-warming you hear a beep. The screen will show a falling drop of blood and a countdown of 180 seconds begins.

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You have 180 seconds to apply a liquid quality control solution to the test

strip. n) 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.

o) 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.

p) Record the result on the CoaguChek XS Plus QC Log and sign that it was reviewed in RALS. After you verify the validity of the control result, discard the test strip, dropper and the reconstituted bottle of quality control solution.

QC result ranges are dependent on CoaguChek XS Plus strip lot number. q) Remove the Quality Control code chip and store it with the opened box of

controls. Re-insert the test strip code chip. r) Power the meter OFF. s) 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. Do not use test

strips from failed QC to test patient samples.

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.

Patient Test 1. The provider will place an order in EPIC for a fingerstick PT/INR using order code

POC1620. Outside provider orders for a fingerstick PT/INR can also be placed for POC1620 by following the Placing Lab Orders for a non-Bassett Provider (tip

sheet). 2. Prior to patient testing, confirm the patient’s visit has been arrived, the patient’s two

forms of identification and have the patient complete the Point of Care Coagulation

Patient Information/Downtime Form (form #8911, see attachment). 3. In EPIC collect the specimen. Refer to the Point of Care PT/INR in Result Entry (tip

sheet steps 1 - 3).

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4. Collect your testing supplies. Check the meter for the correct lot code chip and place

the meter on a flat surface 5. Turn the meter on by pressing the On/Off Button and holding until the meter turns on.

6. 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.

7. 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.

8. Enter operator ID (operator bar code number). Touch () OK to log on. 9. Select PATIENT TEST. Enter patient ID, using the CSN number. ADT

confirmation of the patient’s name is not available on the CoaguChek XS Plus.

Verify that the CSN has been correctly entered.

DO NOT puncture finger until the flashing test strip icon and the falling blood drop symbol appear on the meter screen.

The test strip symbol prompts you to insert a test strip.

Hold the test strip so the lettering “CoaguChek XS PT” is facing upward. 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. Perform the finger puncture at the side of the fingertip. 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. Do not touch the test strip to the fingertip itself, only to the drop of blood. 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.

10. 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 briefly appears after “QC” and the PT/INR

results are displayed. Review results – do not report results with “C” as an error flag. See section L – limitations in this procedure.

11. 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 METER CLEANED comment.

12. Select the MENU icon until the REMOVE menu will appear on the screen. Remove the test strip from the measurement chamber.

13. Place the meter in the downloader and confirm that the meter is communicating with the DMS. Message reads “Communicating with DMS, please wait…”. Successful download message reads “The meter is docked (green). Downloaded results are

sent to RALS and then to the EPIC Outstanding List. If results do not appear in the Outstanding list, re-dock the meter. Contact POC X6728 or 3502 for assistance. See

section L of this procedure – Results Documentation. 14. When you are done testing, turn the meter off. The meter may remain in the docking

station or remove it to extend battery life.

15. Clean the exterior of the meter with Clorox Germicidal Wipes after each use. See cleaning and maintenance section M.

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16. 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 0.9 – 1.1

PT 10.8 – 13.2 seconds Therapeutic Range

INR 2.0 – 3.0 Routine Oral Anticoagulation INR 2.5 – 3.5 Mechanical Valves

H. MEASURING RANGE

Reportable Range INR 0.8 – 6.0

PT 9.6 – 71.9 seconds

Results that are above or below the measuring range are indicated by the symbols >

(above) or < (below).

I. RESULT DOCUMENTATION IN EPIC - Test Order Code POC 1620 - Point of Care Coagulation Patient Information/Downtime Form.

1. From the outstanding list, double click the patient, complete additional optional fields listed below with patient’s responses in Result Entry. All fields are

optional. If the patient has given information for any of the following questions, complete that field with either free text or 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

2. Point of Care Coagulation Patient Information/Downtime Form – In the event of

an EPIC, network, or RALS downtime, the entire form is used for documenting and reporting results as well as documenting critical values called. This form may

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be faxed to an outside provider during downtime. The form when used as a

downtime report must be saved for seven years.

Note: This upper portion of this form serves as a data collection form for the patient’s doses, missed doses, bleeding, etc. The use of this form is optional for this and may be discarded once the results have been verified.

J. CRITICAL VALUE RANGE – Document Critical Value communication in the

COMM LOG in Beaker. Point of Care PT/INR in Result Entry (tip sheet steps

(steps 14B–14C).

Critical Value INR >4.4

K. CONFIRMATORY TESTING – All results >6.0 are reported as such. The order for the

confirmatory PT/INR is automatic and all INRs >6.0 require a sample submitted to the Clinical Laboratory for confirmatory testing. The Beaker label will print to the specimen label printer upon verifying the results. To collect the sample see Point of Care PT/INR in

Result Entry (tip sheet steps 15-17).

Place a small INR confirmatory sticker (form 8989) directly under the patient’s name on the Beaker label. Do not cover the barcoded area or any information on the label. See below.

L. 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%.

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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

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.

M. 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

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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 27-29 Operator’s Manual

N. TROUBLESHOOTING See pages 123-125 Operator’s Manual, call Point of Care x6728 or Technical Support

1-800-428-4674.

O. 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.

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ATTACHMENT

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Title: CoagChek XS System Whole Blood Protime INR Created Time: 10/12/2011 4:51:50 PM Original Approver: Dr. Samantha Davenport

Approval Workgroup: POC Major Changes Approval Workgroup

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Last Reviewed By:

Last Approved By: Davenport, Samantha MD(Chief

of Service, Laboratory) (5/14/2019 7:34:52 AM)

Spoon, Victoria(Manager, Pathology/Cytol.)

(5/14/2019 6:44:27 AM)

Sastry, Simha MD(Sr Attending Physician, Path)

(5/13/2019 4:27:55 PM)

Sharp, Lorie(Technical Specialist POC) (5/13/2019

3:26:21 PM)

Bush, Valerie PhD(Clinical Director) (5/13/2019

1:11:34 PM)

Last Updated Time: 5/14/2019 7:34:52 AM Folder Name: POC {PAGE}

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