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Policies,Clinical,UWHC Clinical,Department Specific,Point of Care,CoaguChek® XS Pro INR

CoaguChek® XS Pro INR (1595.P42)

CoaguChek® XS Pro INR (1595.P42) - Policies, Clinical, UWHC Clinical, Department Specific, Point of Care, CoaguChek® XS Pro INR

1595.P42

UWHC Clinical Laboratories Original Date: 5/20/2016
University Station and West Anticoagulation Clinics Current Version Date: 5/20/2016
Document Title: CoaguChek® XS Pro INR Testing
Document ID: 1595.P42 Page 1 of 11


Effective Date: 4/20/2016
Faculty Director Date Manager Date Technical Reviewer Date
Teresa Darcy, MD Cheryl Jordan Lisa Wilson








University Station Lab
Director
Date
West Clinic Lab
Director
Date Faculty Director Date
Diane Norback, MD Teresa Darcy, MD Eliot Williams, MD










I. Purpose or Principle
This policy will provide a standard method of performing the CoaguChek® XS Pro INR testing
at University of Wisconsin Hospital Anticoagulation Clinics to ensure accurate, quality patient
results. The intended use of the test is to accurately assess hemostasis in patients
anticoagulated with warfarin. This policy will also address testing requirements such as proper
storage and handling of reagents, performance of quality control tests, proficiency testing, and
training and competency assessments. This test may only be performed by properly trained
operators in areas that have been approved to perform the testing, and that meet the
applicable regulatory requirements such as performing the required quality control and
maintaining competency.

Test Measurement:
The CoaguChek XS PT Test Strip contains a lyophilized reagent. The reactive
components of this reagent consist of thromboplastin and a peptide substrate. When a
sample is applied, thromboplastin activates coagulation, which leads to the formation of
thrombin.
At the same time the meter starts to measure the time. The enzyme thrombin cleaves
the peptide substrate, generating an electrochemical signal.
Depending on the time elapsed when it first appears, this signal is then converted by
means of an algorithm into customary coagulation units and the result is displayed.
A. Patient Preparation
1. Refer to Policy 11.12 Capillary Blood Specimen Drawing and Phlebotomy
Department Policy 1507.P010 Skin Puncture Blood Collection.
B. Specimen
1. 8 uL (one drop) fresh capillary whole blood

UWHC Clinical Laboratories Original Date: 5/20/2016
University Station and West Anticoagulation Clinics Current Version Date: 5/20/2016
Document Title: CoaguChek® XS Pro INR Testing
Document ID: 1595.P42 Page 2 of 11


2. Do not use glass tubes to collect blood
C. Handling Conditions
1. Test must be performed within 15 seconds following blood collection.
II. Reagents (or Media), Standards, Supplies and Equipment
A. Reagents and Standards
1. CoaguChek® XS PT Test Strips
a. Store strips at room temperature or in the refrigerator 2 to 30°C (36 to 86°F) with
the cap tightly closed.
b. If stored in refrigerator, bring to room temperature before using.
c. Test strips can be used until expiration date listed on the vial.
d. Discard strips that are past the listed expiration date.
e. Use test strips within 10 minutes or removal from strip vial.
f. Each lot of test strips come with a code chip.
g. Verify the code chip in the meter matches the lot of strips you are using.
h. Do not touch strips with wet hands or gloves.
2. CoaguChek® XS PT Controls
a. Store controls in refrigerator from 2 to 8°C (36 to 46°F). Do not freeze.
b. Unopened controls that are stored at 2 to 8°C are good until the expiration date
listed.
c. Controls are stable for 30 minutes after adding the diluent.
d. Verify code chip in the CoaguChek® XS Pro meter matches the lot of controls you
are using.
B. Equipment and Supplies
1. CoaguChek® XS Pro Meter
2. Transformer (9 volt), rechargeable battery pack or “AA” batteries
3. CoaguChek® XS PT Test Strips and matching code chip
4. MICRO-SAFE® Tube – 50 microliter
5. Lancet device
6. Red sharps container/Biohazard Disposal Receptacle
7. Gloves
8. Sterile gauze
9. Alcohol wipes
10. Gel warmers (CS #2200084)
11. Band Aids
12. CoaguChek® XS Pro PT Controls, Levels 1 and 2
III. Calibration and Calibration Verification
1. The CoaguChek® XS Pro meter is calibrated at the manufacturing facility to test and
verify all functions.
2. The code chip supplied with each box of test strips automatically calibrates the meter
for that particular lot of strips. The code chip provides specific performance
characteristics information to the meter so it is calibrated for use with its
corresponding specific lot of test strips and controls.
3. The manufacturer establishes the performance characteristics based on testing of
specimens from donors on warfarin therapy. Each code chip is verified to show that

UWHC Clinical Laboratories Original Date: 5/20/2016
University Station and West Anticoagulation Clinics Current Version Date: 5/20/2016
Document Title: CoaguChek® XS Pro INR Testing
Document ID: 1595.P42 Page 3 of 11


it will produce expected results. In addition, each time the meter is turned on, it goes
through a series of self-diagnostic checks.
4. Roche Diagnostics tests extensively to be sure calibration data provides analytical
values that correspond to established reference methods and is traceable to the
WHO International Reference Preparations.
5. The CoaguChek® XS Pro cannot be adjusted externally to fit a certain linearity
curve. .
6. The calibration is verified through patient sample comparisons with the main labs,
proficiency testing and sample comparisons between the CoaguChek® XS Pro
meters every 6 months.
IV. Patient Testing Procedure
1. Find the patient’s appropriate test order (INR, POC) in Health Link. Release the
order.
2. If no current order is found, place a standing order and have the attending MD
cosign.
3. Verify that the appropriate liquid quality controls have been performed before
proceeding with patient testing (See Quality Assurance, Section IX).
4. Assemble equipment. Ensure test strips are at room temperature and are within
expiration date. Do not use expired materials.
5. Prior to blood collection, identify the patient using two acceptable identifiers (name
and date of birth or medical record number.)
6. Place meter on a flat surface free of vibration, or hold meter in your hand so it is
horizontal. Do not move meter during testing phase.
7. Take a strip out of the vial and insert into the meter so the lettering “CoaguChek XS
PT” is facing up and in the direction of the arrow.
8. Insert strip as far as it will go. This will turn the meter on. An audible beep means
that the meter has recognized the test strip.
9. Check the battery level. If there are no bars left in the battery symbol, you cannot
perform any more tests until the batteries are changed/recharged or the meter is
plugged in.
10. Enter your Operator ID. Press “Scan” button on main screen and scan the barcode
on your ID badge using the scanner on the right side of the meter or manually enter
the numbers. Touch √ (OK) to log on and move to the main menu.
11. If QC Lockout is displayed instead of “Patient Test”, the liquid controls will need to be
performed prior to patient testing.
12. Press “Patient Test” on the main menu.
13. Scan the patient ID (medical record number). Manually enter if unable to scan.
Touch √ (OK).
14. An hourglass symbol indicates the test strip is warming up.
15. Observe the instrument for any fault messages before continuing.
16. Confirm the three number code number displayed on the meter matches the number
on the test strip vial. Insert new code chip if using a new lot of strips.
a. The data from up to 60 code chips can be stored in the meters.
b. Leave the code chip in the instrument when not in use to protect electrical
contacts in the meter from becoming dirty.
c. Only remove code chip when testing from a new pack of strips.

UWHC Clinical Laboratories Original Date: 5/20/2016
University Station and West Anticoagulation Clinics Current Version Date: 5/20/2016
Document Title: CoaguChek® XS Pro INR Testing
Document ID: 1595.P42 Page 4 of 11


d. To install code chip, be certain meter is OFF. Remove old code chip and insert
new one with printed side up in code chip slot located at top of meter until it
snaps into place.
17. When ready, the instrument will flash a blood drop symbol to indicate that you may
apply blood to the strip.
18. You will have 180 seconds to collect the blood sample and apply to the strip.
19. Cleanse the patient’s fingertip with an alcohol wipe and allow to air dry. Use a hand
warmer if the patient’s hands are cold.
20. Incise the fingertip with a lancet device. Massage fingertip from base to tip to form a
rounded drop of blood. (Refer to Phlebotomy Departmental Policy 1507.P010, Skin
Puncture Collection for proper blood drawing procedure.)
21. Dispense blood directly onto the test strip within 15 seconds of skin puncture. (Note:
Test strips must be used within 10 minutes of removing from vial.)
22. Optionally, collect blood sample using a 50 microliter Microsafe
®
Tube.
23. Apply first drop of blood to the top or side of the semicircular, transparent sample
application area within 15 seconds. Hold the blood drop to the test strip until you
hear a beep. Do NOT wipe away the first drop of blood.
24. Keep meter level during the testing phase.
25. Discard lancet in red sharps container.
26. During test, the meter automatically performs a two level, on board quality control
test on the test strip before it displays the test result.
27. Following a successful quality control test, a check mark appears after the “QC”.
28. Upon test completion, results are displayed.
29. You may “Accept” or “Reject” the test result. If choosing “Reject”, a comment must
be entered. Press the “balloon” icon on the bottom right hand of the screen and enter
a predefined comment or press √ to return to the results screen. Refer to
CoaguChek programmed comments attachment 1595.P8.A3
V. Place the meter in the base to download the patient’s result into the electronic medical
record.
VI. Method Specification
A. AMR (Analytical Measurement Range)
1. The analytical measuring range of the instrument for INR has been determined to be
0.8 to 3.9 (See CoaguChek® XS Pro INR validation report).
2. Any result obtained that is less than 0.8, greater than 3.9 or unexpected for the
clinical presentation of the patient after repeating will be verified by a venipuncture
INR test from the main lab. The venipuncture INR result will be used for treatment of
the patient.
3. The AMR of the instruments will be verified at least every six months through
proficiency testing, quality control and patient sample comparisons with the main lab.
B. Interferences
1. Samples with hematocrit values between 25% and 55% do not significantly affect
test results.
a. The letter “C” appearing to the right of an INR result may indicate
a hematocrit outside of this range. Repeat the INR.

UWHC Clinical Laboratories Original Date: 5/20/2016
University Station and West Anticoagulation Clinics Current Version Date: 5/20/2016
Document Title: CoaguChek® XS Pro INR Testing
Document ID: 1595.P42 Page 5 of 11


b. If the letter “C” appears on the repeated INR result, the INR
should be repeated by venipuncture. The provider should be
contacted to place an order for a hematocrit if deemed necessary.
2. The results are unaffected by heparin concentrations up to 0.8 U/mL.
3. The CoaguChek® XS Pro is unaffected by low molecular weight heparin up to 2 IU
anti-factor Xa activity.
4. Studies indicate that interferences may occur in patients with antiphospholipid
antibodies or antiphospholipid syndrome.
5. The CoaguChek® XS Pro System should not be used on patients being treated with
any direct thrombin inhibitors, including Hirudin, Lepirudin, Bivalirudin, and
Argatroban.

C. Limitations and/or Exceptions

1. The CoaguChek® test strip is affected by poor technique including blood collection
and the transfer of blood to the sample well. The quality of the blood specimen may
be affected by:
a. Bubbles in the sample
b. Inadequate sample volume
c. Clotted or partially clotted blood
d. Samples contaminated with tissue thromboplastin, IV solutions, alcohol cleansing
solution
e. Samples from excess squeezing/manipulation of finger, or poorly flowing blood.
2. Test strip must be used within 10 minutes of removal from vial and dosed within 15
seconds of blood collection.
3. If “Error 6” or “Error 7” are displayed repeatedly, the patient should be sent to the
main lab for a VP INR.
4. Test results should be scrutinized in light of a specific patient’s condition and
anticoagulant therapy. Any results exhibiting inconsistency with the patient’s clinical
status should be repeated or supplemented with additional test data.

VII. Procedure Notes

A. Do not use test strips that are passed their marked expiration date, or that have been
improperly stored.
B. Do not expose the CoaguChek® XS Pro to extremes in temperature. Meter should be
used at a room temperature of 15° to 32°C (59° to 90°F).
C. When testing, place the meter on a level, vibration free surface or hold horizontally.

VIII. Result Reporting and Interpretation

A. Unexpected results should be repeated or confirmed by venipuncture INR prior to
changing therapy.
B. The INR results will be directly downloaded into the patient’s electronic medical record
from the instrument.
C. The INR result will be compared to the patient specific target range. Target ranges may
vary from patient to patient depending on their specific indication for anticoagulation and
individual past history.

UWHC Clinical Laboratories Original Date: 5/20/2016
University Station and West Anticoagulation Clinics Current Version Date: 5/20/2016
Document Title: CoaguChek® XS Pro INR Testing
Document ID: 1595.P42 Page 6 of 11


D. A list of comments is programmed into the CoaguChek XS Pro meters.
E. Any INR test that is rejected will automatically be held in the RALS system until released
by the POC Coordinator or Designee.

F. If the INR result is greater than 3.9, an electronic order will be placed and the patient will
be sent to the lab to have the test repeated by venipuncture. The venipuncture result will
be used to adjust the patient’s warfarin dosing. These results will be recorded in the
Elevated INR Results Log and the appropriate comments entered electronically.
G. Per hospital policy, the pharmacist is immediately notified by the Clinical Laboratory of all
critical INR’s (greater than or equal to 5.0.) The pharmacist also documents this in the
clinical note in the patient’s electronic health record.
H. If the INR result is less than 0.8, the test will be repeated. If this result is also less than
0.8, the patient will be given a lab order and sent to the lab for a venipuncture. The
venipuncture result will be used to adjust the patient’s warfarin dosing.
I. If the collector feels the quality of the specimen is in question or adulterated in any way,
the test should be repeated. Entering the comment of “Invalid” or rejecting the result will
hold the result and it will not be entered into the patient’s medical record.
J. If the clinician cannot obtain a sample after 2 attempts, the patient will be given a lab
order for lab for a venipuncture blood test for an INR. The venipuncture result will be
used to adjust the patient’s warfarin dosing.
K. Test results should be scrutinized in light of a specific patient’s condition and
anticoagulant therapy. Any results exhibiting inconsistency with the patient’s clinical
status should be repeated and if deemed appropriate the patient should be sent to lab for
a venipuncture INR blood test. An appropriate comment should be entered electronically
with the result and the POC result will not be entered to the patient’s medical record.
L. A log of patients’ unexpected results and their corresponding venipuncture results will be
kept. The purpose of this log is to track occurrences of point-of-care (POC) finger stick
results that are not expected or explained by clinically identifiable factors or variables.
1. Unexpected result is defined to be any result that is unusual to normal fluctuation,
with significant variation out of target INR range, and no factors or variables in
dosing, adherence, lifestyle issues (diet/alcohol/activity/illness/exacerbation of
conditions such as CHF), or medication changes were able to be attributed as the
cause, based on Pharmacist clinical judgement. Example: INR has been stable in
the 2.0-3.0 range for 1 – 2 months and now is at or near 1.0 or greater than 4.0 and
patient denies any changes in diet, alcohol use, activity level, OTC or prescription
medications. This is to be documented in the Unexpected Results Log.
2. Elevated result is defined to be any POC INR result greater than 3.9. The patient will
be sent to the laboratory for a venipuncture INR. Both the POC and venipuncture
INR results will be recorded in the Unexpected/Elevated results log.
3. Procedure for dealing with unexpected results:
a. When an unexpected result is determined, document the following into the
Unexpected Results Log: date, time, medical record #, strip lot # and expiration
date, POC INR test result, meter used, person performing the POC test, and any
additional comments about the POC sample collection or patient factors that may
affect the INR. Enter the appropriate comment electronically with the result.
b. If an invalid result gets released into the patient’s medical record, call the Point of
Care Testing office at 890-9360, 263-8039 or 263-5589 to have a correction filed.
Give the date and time of result, value, patient name and medical record number.

UWHC Clinical Laboratories Original Date: 5/20/2016
University Station and West Anticoagulation Clinics Current Version Date: 5/20/2016
Document Title: CoaguChek® XS Pro INR Testing
Document ID: 1595.P42 Page 7 of 11


c. Complete clinical assessment with patient in clinic.
d. Send patient to the laboratory with an order for a venipuncture INR blood test.
e. Phone patient with venipuncture INR result and adjust dose of warfarin according
to this result.
f. Record venipuncture INR result into patient’s record and also into the
Unexpected Results Log.
IX. Safety
A. Wear gloves when handling patient samples or liquid QC materials.
B. Use proper hand hygiene when testing patients (See UWHC Policy 13.08, Hand Hygiene).
C. Used CoaguChek® test strips and controls should be considered as potentially infectious.
They should be handled according to individual institutional policies concerning the
disposal of potentially infectious materials. (See UWHC Policy 13.07, Standard
Precautions and Transmission-based Precautions and 13.09, Sharps Disposal).
D. All reagents have been reviewed for risk including reproductive toxicity, acute toxicity, and
carcinogenic potential. None were found.

X. Quality Assurance

A. Electronic and Internal Quality Control
1. A check of the electronic components and functions is performed every time the meter
is turned on.
2. A check of the strip temperature, expiration date and lot information on the test strip is
performed with each test.
3. A two level, on board quality control is test is performed on each test strip with each
test.
4. All the quality control results are stored electronically and will be downloaded to the
Clinical Laboratories Point of Care Information system. Records will be retained for at
least two years. Results will be reviewed at least weekly by the Point of Care Testing
Coordinator.
5. If the results are unacceptable after repeat testing or there are any error messages,
remove the device from service and do not use for patient testing.
6. Call Roche Technical Services at 1-800-428-4674 for assistance and notify the Point
of Care Testing Office in the Clinical Laboratories at 263-8039 or 263-5589.
B. CoaguChek® XS Pro PT Controls
1. Storage and Handling
a. Each kit of CoaguChek® XS Pro PT Controls contains 4 bottles of Level 1 control, 4
bottles of Level 2 control, 8 diluent droppers and one quality control code chip.
b. When stored at 2 - 8°C, the controls are good until the expiration date on the box.
c. Reconstituted vials should be used within 30 minutes.
d. The acceptable ranges (package insert ranges are used) are programmed into the
meter by inserting the QC code ship.
2. Testing Procedure
a. The Level 1 and Level 2 CoaguChek XS Pro PT liquid controls are required to be
performed:
1. Whenever opening a new box of test strips. Write date strips were opened on
vials.

UWHC Clinical Laboratories Original Date: 5/20/2016
University Station and West Anticoagulation Clinics Current Version Date: 5/20/2016
Document Title: CoaguChek® XS Pro INR Testing
Document ID: 1595.P42 Page 8 of 11


2. Every 30 days thereafter on any opened vials of strips.
3. Each CoaguChek® XS Pro used for patient testing must have liquid controls
performed at least monthly (see 1595.P42.A2, CoaguChek® XS Pro IQCP.)
4. The instruments are programmed to lock out the user from patient testing if the
liquid controls are not performed in the required 30 days.
5. The instrument will display “QC Lockout” and the controls must be performed and
within the acceptable ranges before patient testing can occur.
b. Remove control vials and diluent from the refrigerator.
c. Verify expiration dates on strips and controls. Do not use expired materials.
d. Handle test strips and controls as biohazardous materials using standard
precautions. Dispose of used materials in accordance with standard medical waste
disposal policy.
e. Reconstitute the liquid controls.
1. Label the control vial with the date and time reconstituted.
2. Remove the screw cap and rubber stopper from the control vial.
3. Using a scissors, cut off the tip of the dropper by the stem holding away from
face; do not squeeze the bulb on the dropper while cutting the tip.
4. Invert the dropper and place the tip in the bottle, taking care not to touch the
dried material at the bottom.
5. Gently squeeze the dropper until all of the diluent has been dispensed.
6. Mix the control by swirling gently in a circular motion.
f. Insert test strip into the strip slot on the bottom of side of the meter. Meter will turn
on. Verify three digit code on test strip vial matches the code chip in the meter.
g. Scan or manually enter operator ID.
h. Press the “QC Test” on main menu.
i. If opening a new lot of QC solution, insert the code chip from the QC kit to input the
new lot information. Verify code on meter matches code on QC vial.
j. Select Level of control (L1 or L2).
k. An hourglass symbol will appear indicating that the meter is warming the strip.
l. A dropper symbol will appear to indicate that the meter is ready to perform the test
and is waiting for the control solution to be applied. A 180 second countdown
begins.
m. Gently swirl the control vial to mix. Do not mix solution with the dropper.
n. Draw control solution into the dropper and dispense the liquid on the top of the target
area on the test strip.
o. An hourglass symbol will appear when enough sample has been added and you will
hear an audible beep tone.
p. In approximately one minute, results will display. The acceptable range of results is
displayed below the current result.
q. If the quality control test fails, an up arrow (too high) or down arrow (too low) will
flash on the display.
r. Save extra control in the bottle. Repeat any unacceptable result using a new test
strip.
s. Control is good for 30 minutes after reconstitution.
t. If results are still unacceptable, repeat using new control vial and test strip.
u. If unable to resolve issue, use a different meter for patient testing. Call Point of Care
Testing Coordinators at 890-9360, 263-5589 or 263-8039 to report.

UWHC Clinical Laboratories Original Date: 5/20/2016
University Station and West Anticoagulation Clinics Current Version Date: 5/20/2016
Document Title: CoaguChek® XS Pro INR Testing
Document ID: 1595.P42 Page 9 of 11


v. Results are stored in the instrument. The result, date, time, operator, lot numbers,
acceptable ranges and expiration dates of controls and strips will be documented
electronically in the laboratory software system.
w. Package inserts for each lot of control are kept for two years. Quality control results
are reviewed at least weekly by the Point of Care Testing Coordinator
3. Quality Control Evaluation
a. Acceptable ranges for each new lot number of Quality Control Product are entered into
the connectivity. (Refer to 1595.P42.A3 New QC Lot Procedure for instructions.) The
lot number, expiration date and acceptable ranges are downloaded into the Clinical
Laboratories Point of Care Information software system by inserting the new chip
supplied with the Quality Control Product.
b. Repeat any unacceptable (failed) result and document the corrective action by
entering a comment before removing the test strip (Repeat QC, Wrong QC Level, etc.)
c. If the repeated result is still outside of the acceptable range, do not use the instrument
for patient testing and remove from service.
d. Use an alternate CoaguChek® XS Pro until the appropriate corrective action has been
completed and controls are acceptable.
e. Notify the Point of Care Testing office in the Clinical Laboratories at 263-8039 or 263-
5589.
f. Refer to the CoaguChek® XS Pro Operator’s Manual Troubleshooting section should
any error message appear on the display during this procedure.
4. Quality Assurance
a. Proficiency Testing
1. Each testing site will enroll and participate in an approved proficiency testing
program at least three times per year.
2. Proficiency testing should be rotated both among staff that perform patient
testing and CoaguChek® XS Pro meters used for patient testing.
3. Proficiency testing attestation forms should be signed by the CLIA Director or
approved Designee and the staff member performing the testing.
4. All proficiency testing reports must be reviewed and signed by the CLIA Director
or designee.
5. Results of 100% are expected and any deviations should be reported to the
medical director and/or manager.
6. For any incorrect results, an investigative review and a follow up corrective action
plan must be documented and signed by the CLIA Director or designee and
attached to the results.
7. Staff may enter the medical record number of “7777777” when running
proficiency testing samples and place the appropriate comment on the results.
b. Patient Sample Comparisons
1. At least three patient sample comparisons between the CoaguChek® XS Pro
meters at University Station Anticoagulation Clinic and the meters at West
Anticoagulation Clinic will be performed every six months. Results should
correlate within ±20%.
2. Any results outside the acceptable limits will be investigated. Any instrument that
repeatedly does not meet the comparison criteria will be sent in for service/repair.
c. Patient Data Review
1. Patient results are reviewed immediately by the Pharmacist. The results are
reviewed based on the clinical picture of the patient.

UWHC Clinical Laboratories Original Date: 5/20/2016
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Document Title: CoaguChek® XS Pro INR Testing
Document ID: 1595.P42 Page 10 of 11


2. Results are reviewed daily by the Point of Care Coordinators in the Clinical
Laboratories.
d. Training and Competency Assessment
1. All staff that perform INR testing on the CoaguChek XS Pro are trained and
competent before performing any patient testing. Initial training is documented
and records retained.
2. In their first year of testing, all staff are required to complete two competency
assessments (at around 6 months after start of employment and at one year.)
3. After their first year of testing, all staff are required to complete an annual
competency assessment.
4. Any unsatisfactory competency assessment will be followed up with retraining.
The staff member will not perform any patient testing until acceptable
competence is achieved.
5. Copies of these competency records will be kept at the testing sites for at least
two years. (See 1595.P42.F1 Training and Competency form.)
XI. Maintenance
A. Each CoaguChek® XS Pro meter must be cleaned between each patient use using a
disinfectant ( 70% isopropyl alcohol). Let the meter dry for at least 10 minutes.
B. Inspect and clean the test strip guide as required.
C. Do not use solvents or strong cleaning solutions. They may damage plastic components.
D. Routine maintenance other than cleaning is not required.
XII.Alternate Testing and/or Down Time Procedures
A. If a CoaguChek® XS Pro is malfunctioning or broken, use an alternate instrument for
patient testing.
B. If no functional CoaguChek is available, send the patient to the main lab to obtain a VP
INR test.
C. Daylight Savings Time Change
At the beginning and end of Daylight Savings Time.
1. Download the meter to capture the time change.
XIII.References
A. CoaguChek® XS Pro Operator's Manual distributed by Roche Corporation. Indianapolis,
Indiana.
B. CoaguChek PT strip package insert, Roche Corporation. Indianapolis, Indiana.
C. CoaguChek XS Pro PT Controls package insert, Roche Corporation. Indianapolis, Indiana. .
D. NCCLS. Point-of-care monitoring of anticoagulation therapy; approved guideline.
Document H49-A (ISBN 1-56238-540-2). February, 2010.

XIV. Related Documents
A. CoaguChek® XS Pro INR Validation Report, Point of Care Testing Office
B. Hospital Administrative Policy 13.07, Standard Precautions and Transmission–based
Precautions (Isolation)
C. Hospital Administrative Policy 13.08, Hand Hygiene
D. Hospital Administrative Policy 13.09, Sharps Disposal

UWHC Clinical Laboratories Original Date: 5/20/2016
University Station and West Anticoagulation Clinics Current Version Date: 5/20/2016
Document Title: CoaguChek® XS Pro INR Testing
Document ID: 1595.P42 Page 11 of 11


E. Hospital Nursing Patient Care Policy 11.12, Capillary Blood Specimen Drawing
F. Phlebotomy Department Policy 1507.P010, Skin Puncture Blood Collection
XV. Appendices and Forms
A. 1595.P42.A1 CoaguChek® XS Pro Training and Competency Quiz Key, April, 2016
B. 1595.P42.A2 CoaguChek® XS Pro IQC Plan, April, 2016
C. 1595.P42.A3 CoaguChek® XS Pro New QC Lot Procedure, April, 2016
D. 1595.P42.F1 INR by CoaguChek® XS Pro Training and Competency Form, April 2016
E. 1595.P42.F2 Annual Review and Changes Log, April 2016
XVI.Author and/or Revised By
Janis Parkinson, MT (ASCP)
XVII.Coordination and/or Review
Anticoagulation Clinics Manager
Director, Lab Services
Point of Care Testing Faculty Director
Point of Care Testing Coordinators
CLIA Laboratory Directors University Station and West Clinics