Roche CoaguChek XS System Reference guide

Policies & Procedures Manual
This Policies and Procedures Manual was prepared by Roche Diagnostics with the contribution of Sheila Dunn,
D.A., MT(ASCP). It contains sample policies and procedures to help you provide the highest quality
anticoagulation testing program. We hope this manual becomes a valuable tool for you and your staff. Before
using the CoaguChek XS System, customize this Policies & Procedures Manual to reflect the actual
circumstances of your testing program by entering your specific protocol in the spaces indicated. Review and
modify this program as desired to meet your own medical practice needs and to accommodate any future
changes to CLIA or other applicable regulations. Because procedures are subject to occasional change, always
refer to the reagent package insert for the most current information and modify this manual accordingly.
For assistance with any aspect of your anticoagulation management program, contact Roche Diagnostics
Technical Service Center at 1-800-428-4674, available 24 hours a day, 365 days a year.

Copyright 2008-2012. Roche Diagnostics. All Rights Reserved. The author(s) and their agent(s) have made every reasonable effort in the
preparation of this publication to ensure the accuracy of the information. However, the information in this Manual is sold without
warranty, either expressed or implied. Neither the authors, editors, their agents nor publishers will be liable for any damages
caused or alleged to be caused directly, indirectly, incidentally, or consequentially by the information in this publication. This
publication cannot and does not provide specific information for a user's exact situation. Users of this publication should exercise their own
judgment, and where appropriate, seek the assistance of legal, medical or professional counsel regarding their particular situation or
obligations under CLIA or state laboratory regulations.
COAGUCHEK is a trademark of Roche. All other trademarks are the property of their respective owner.
4625-00-0212

Policies & Procedures Manual for
the CoaguChek XS System
Table of Contents
Getting Started With the CoaguChek XS System ................................................................................. i
Policies and Procedures Approval Form...............................................................................................ii
SECTION 1: SYSTEMATIC ANTICOAGULATION MANAGEMENT (SAM) PROGRAM OVERVIEW 1-
1
Purpose of the SAM Program...........................................................................................................1-1
SAM Performance Goals (financial, clinical and operational).....................................................1-1
1Campell P, Radensky P, Denham C. Economic analysis of systematic anticoagulation
management vs. routine medical care for patients on oral warfarin therapy. Disease
Management and Clinical Outcomes, 2000;2.CoaguChek XS Meters Used in the SAM Program1-
1
SAM Program Director...............................................................................................................1-2
Individuals Involved in the SAM Program...................................................................................1-2
Policies and Procedures for the SAM Program.................................................................................1-3
SECTION 2: PERSONNEL TRAINING POLICIES AND PROCEDURES .........................................2-1
Personnel Policies............................................................................................................................2-1
Anticoagulation Program Director Responsibilities.....................................................................2-1
Operator Qualifications ..........................................................................................................2-2
CoaguChek XS Operator Responsibilities..............................................................................2-2
Procedures for CoaguChek XS Operator Training and Evaluation....................................................2-4
Operator Training/Certification...................................................................................................2-4
Suggested In-service Curriculum ...........................................................................................2-4
Operator Competency Evaluation (Optional) ...........................................................................2-11
SECTION 3: METHOD COMPARISON (OPTIONAL).......................................................................3-1
Suggested Procedure for Method Comparison.................................................................................3-1
Sources of Error in Method Comparison Studies.......................................................................3-2
SECTION 4: SAFETY IN THE TESTING AREA ...............................................................................4-1
Safety Policies..................................................................................................................................4-1
Safety Procedures............................................................................................................................4-1
Safety Precautions for the Testing Area ....................................................................................4-1
Safety Precautions for Working with Potentially Infectious Material ...........................................4-1
Hazardous Waste Disposal........................................................................................................4-2
In Case of Accident ...................................................................................................................4-2
Procedure for Reporting Device-Related Adverse Events......................................................4-2
SECTION 5: PREANALYTIC POLICIES AND PROCEDURES ........................................................5-1
Policies for the Preanalytic Phase of Testing....................................................................................5-1
Procedures for:................................................................................................................................. 5-1
Test Ordering ............................................................................................................................5-1
Handling Incomplete Requisitions..............................................................................................5-1
Standing Orders ........................................................................................................................5-1
Specimen Collection and Handling............................................................................................5-1

Fingerstick Blood Collection Procedure..................................................................................5-2
Venipuncture Procedure ........................................................................................................5-3
Specimen Handling ...................................................................................................................5-4
Specimen Accessioning.............................................................................................................5-4
Specimen Rejection Criteria...................................................................................................5-4
SECTION 6: ANALYTIC POLICIES AND PROCEDURES................................................................6-1
Analytic Testing Policies...................................................................................................................6-1
Meter Settings...........................................................................................................................6-1
Procedures for:................................................................................................................................. 6-1
Setting Time and Date...............................................................................................................6-1
Storing the Meter and Test Strips..............................................................................................6-1
Code Chip Storage and Stability................................................................................................6-2
Ordering Test Supplies..............................................................................................................6-3
Onboard Quality Controls .................................................................................................................6-4
QC Procedures................................................................................................................................. 6-4
Troubleshooting Out of Control QC Results...............................................................................6-4
QC Record Retention ................................................................................................................6-4
Calibration: Coding the Meter with the Code Chip ............................................................................6-4
Procedure for Performing Patient Tests............................................................................................6-5
Testing Patient Samples............................................................................................................6-5
Turnaround Time.......................................................................................................................6-6
Procedure Notes........................................................................................................................6-6
Limitations of the Procedure......................................................................................................6-8
SECTION 7: POSTANALYTIC POLICIES AND PROCEDURES......................................................7-1
Policies for Interpreting, Reporting and Recording Test Results .......................................................7-1
Procedures for:................................................................................................................................. 7-1
Normal (Reference) Ranges......................................................................................................7-1
Reportable Ranges (Operating Ranges)....................................................................................7-1
Interpreting Results ...................................................................................................................7-2
Recognizing Unusual or Clinically Inconsistent Results..........................................................7-2
Critical/Alert/Action Value Procedures.......................................................................................7-2
Recording and Reporting Results..............................................................................................7-3
Correcting Erroneous Test Results and Issuing Corrected Reports...........................................7-3
Ensuring the Security of Patient Test Results............................................................................7-4
Procedures for Using Alternative Methods.................................................................................7-4
Communications and Laboratory Complaints ............................................................................7-4
Incident Management................................................................................................................7-4
Procedure for a Power Failure...................................................................................................7-5
Replacing the Batteries..............................................................................................................7-5
SECTION 8: QUALITY ASSESSMENT ............................................................................................8-1
QA Policies.......................................................................................................................................8-1
QA Procedures.................................................................................................................................8-1
Split Sample Procedure.............................................................................................................8-1
Sources of Error in Split Sample Studies................................................................................8-3
SECTION 9: FORMS........................................................................................................................9-1
Forms Index .....................................................................................................................................9-1
CoaguChek XS Operator Certification Checklist.........................................................................9-2

Operator Certification Test..........................................................................................................9-3
CoaguChek XS Operator Evaluation Checklist (Optional)...........................................................9-5
CoaguChek XS Method Comparison Log (Optional)...................................................................9-6
CoaguChek XS Patient Test Log ................................................................................................9-7
Monthly QA Checklist..................................................................................................................9-8
Split Sample Log (Optional)........................................................................................................9-9
SECTION 10: APPENDICES..........................................................................................................10-1
Appendices Index...........................................................................................................................10-1
Appendix A. Regulations Governing Testing............................................................................10-2
Appendix B. HOSPITAL: NATIONAL PATIENT SAFETY GOALS............................................10-5

i
Getting Started with the CoaguChek XS System
Where to Find Help
Before You Begin Testing Patients
Step 1: Define the purpose, goals and structure of your systematic
anticoagulation management (SAM) program.
Section 1
Step 2: If your facility does not currently hold a CLIA certificate, apply to the CLIA
program for a certificate of waiver. If your facility already has a CLIA
certificate, no action is necessary.
Appendix A
Step 3: If your facility is located in a state with more stringent regulations than the
federal CLIA program such as Maryland or Pennsylvania, OR if your
facility is accredited by either the College of American Pathologists (CAP)
or the Joint Commission, determine any other necessary enrollment
forms or quality requirements for CLIA-waived testing on the CoaguChek
XS.
Appendix A
Step 3: (Optional) If required by state regulations or if the SAM program director
requests it, perform a study to determine the instrument bias between the
new CoaguChek XS System and your previous method for PT/INR
testing. Place results on the CoaguChek XS Method Comparison Log.
Section 2
Step 4: Read this Manual and fill-in-the-blanks to indicate your exact procedures
for testing. Strike through those procedures that are not performed in
your facility (initial and date this change) or add verbiage to indicate
additional procedures that pertain to your SAM program.
This Policies &
Procedure Manual
The SAM program director signs the Policies & Procedures
Approval Form to accept these customized procedures.
Page ii
Step 5: Ensure that all operators have been trained to perform patient tests. File
the completed CoaguChek XS Operator Certification Checklist.
Section 2
Be sure all operators are aware of the key points specified in this
Policies & Procedures Manual and have signed the Policies &
Procedures Approval Form.
Section 1
Once Testing Has Begun
Each Day of Testing:
Ensure that on-board QC results are acceptable during testing.
Follow the policies and procedures in this Manual for collecting and handling samples,
testing patient samples, and reporting test results.
Log patient tests on the CoaguChek XS Patient Test Log.
Once a Month (optional):
Complete the Monthly QA Checklist. This checklist ensures that the testing aspect of your
entire anticoagulation management program is optimal.
Every 3- 6 Months (optional):
Perform an external evaluation of accuracy, such as split sample testing or have two
operators test the same patient and compare results.
As Needed:
Train new operators using the CoaguChek XS Operator Certification Checklist.
Evaluate whether the anticoagulation management program is achieving stated goals

ii
CoaguChek XS System Policies & Procedures Approval Form
This Policies & Procedures Manual for our Systematic Anticoagulation Management Program
was read by:
Date
Name/Title
Prepared/Customized By (Name/Title): ________________________________________
Approved By (SAM program director): ________________________________________
Date Adopted: ___________________ Date Discontinued: ___________________
Revisions:
Revision
Date
Revised By
Approved By
Read By

1-1
SECTION 1: SYSTEMATIC ANTICOAGULATION
MANAGEMENT (SAM) PROGRAM OVERVIEW
Purpose of the SAM Program
Anticoagulation is a high-risk treatment that can lead to adverse events due to the complexity of
dosing anticoagulation medications, monitoring their effects, and ensuring patient compliance
with outpatient therapy. The use of standardized practices that include rapid test results and
patient involvement can reduce the risk of adverse events associated with the use of warfarin or
Coumadin®(Warfarin Sodium Tablets, USP, Bristol-Meyers Squibb Company)1. Other purposes
for the SAM program are:
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
SAM Performance Goals (financial, clinical and operational)
Define the context in which CoaguChek XS System test results are used in patient care,
treatment and services:
To better manage patients receiving warfarin therapy by monitoring their INR values to be
sure that patients are taking the correct dose and are complying with therapy.
To have a rapid INR result in order to use it as one of the criteria to determine optimum
patient therapy.
To reduce the likelihood of adverse events associated with the use of anticoagulation
therapy.
To establish baseline INRs for patients being started on warfarin.
To discuss patient test results during the visit, which enhances compliance with therapy and
dietary restrictions.
Other performance goals specific to this facility:
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
1Campell P, Radensky P, Denham C. Economic analysis of systematic anticoagulation management vs. routine medical care for
patients on oral warfarin therapy. Disease Management and Clinical Outcomes, 2000;2.

1-2
CoaguChek XS Meters Used in the SAM Program
Location/Date Put in Use
CoaguChek XS Serial Number
____________________________________
____________________________________
____________________________________
____________________________________
____________________________________
____________________________________
____________________________________
____________________________________
____________________________________
____________________________________
____________________________________
____________________________________
____________________________________
____________________________________
SAM Program Director
__________________________________________ is responsible for the overall performance
and administration of the anticoagulation monitoring program, including oversight and
coordination of the development, testing, and implementation of the testing program. The
program director ensures that only certified operators perform testing on the CoaguChek XS
meters.
Individuals Involved in the SAM Program
Indicate those responsible for management, testing, providing education to patients and their
families, safety and regulatory compliance:
Name
Title
Role(s) on SAM Team
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________
_________________________
_____________________
___________________________

1-3
Policies and Procedures for the SAM Program
Our policies and procedures for the SAM program are located in this manual and are arranged
according to CLIA regulation requirements for performing laboratory tests. Note that Sections 5,
6 and 7 are arranged according to the sequence of testing:
Preanalytic –tasks performed before the test is performed
Analytic –the test process
Postanalytic –tasks performed after the test is completed
Preanalytic Testing Phase
Postanalytic Testing Phase
Test ordered on requisition or chart
Patient treatment decision made
Order transferred to testing personnel
Test result interpreted by clinician
Specimen collected and applied to
strip
Report generated and conveyed to
clinician
Patient test logged
Results checked by testing
personnel
Analytic Testing Phase
Patient specimen is
analyzed only after meter
function checks are OK

2-1
SECTION 2: PERSONNEL TRAINING POLICIES AND
PROCEDURES
Personnel Policies
Persons who perform tests on the CoaguChek XS system have the proper training and
experience to provide high quality PT/INR test results and thus achieve the anticoagulation
management program goals.
Those who perform tests on the CoaguChek XS system are termed “testing analysts” or
“operators.” As required by the federal Clinical Laboratory Improvement Amendments of 1988
(CLIA), all CoaguChek XS operators receive extensive training prior to using the CoaguChek
XS system for patient testing. In this facility, only those personnel “certified” to operate the
CoaguChek XS system may perform tests.
Anticoagulation Program Director Responsibilities
The anticoagulation program director is available for on-site, telephone, and electronic
consultation as needed. The anticoagulation management program director approves this
Policies and Procedures Manual (page ii) and ensures that all testing personnel are competent
to perform test procedures and to record and report test results accurately.
CoaguChek XS operators are to report any situation that could affect test performance or
compromise employee or patient safety to the anticoagulation management program director.
The anticoagulation management program director ensures that:
Test methodologies provide quality results and are adequate to determine accuracy,
precision, and other performance characteristics.
Test operators are qualified to perform their responsibilities and perform tests according
to the manufacturer’s instructions to obtain accurate and reliable results.
Test operators have documented evidence of training (CoaguChek XS Operator
Certification Checklist) before testing patient samples.
This Policies & Procedures Manual is available to CoaguChek XS operators.
CoaguChek XS operators have signed the Policies & Procedures Approval Form on
page ii.
Any time there is a change in the test procedure or any other part of the anticoagulation
management progr
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

2-2






am, personnel are notified and signify their understanding by signing the Policies &
Procedures Approval Form on page ii.
Test results are reported only when all performance specifications for a test are within
acceptable limits.
Remedial actions are taken and documented when required. When instrument problems
are detected, all patient results obtained since the last acceptable quality control run are
evaluated to determine if they have been adversely affected.
Result reports include pertinent information required for interpretation.
Operator Qualifications
In this facility, all operators must be certified to perform CoaguChek XS tests. Operator
certification is documented on the CoaguChek XS Operator Certification Checklist (FORMS
Section).
CoaguChek XS Operator Responsibilities
Testing analysts are responsible for:
Performs test methods as specified, following this facility’s procedures for specimen
handling and processing, test performance, and reporting and maintaining records of
patient results.
Notes and documents quality control results and performs instrument cleaning when
needed.
Follows established corrective actions whenever QC or patient test results are not within
the established acceptable levels of performance.
Can identify problems or factors that may adversely affect test performance or reporting
of results and either corrects the problem or notifies the anticoagulation management
program manager or director.
Documents all corrective actions taken when problems occur.
Reports concerns of safety and quality of patient testing to the Anticoagulation
management program director.
Reports device-related adverse events to FDA’s MedWatch.
In this facility, the following personnel are authorized to perform CoaguChek XS testing:
Testing analyst (Operator)
Supervision
Required?
(circle one)
Supervisor Review to Report
Results?
(circle one)
_____________________________
Yes No
Yes No
_____________________________
Yes No
Yes No
_____________________________
Yes No
Yes No

2-3
_____________________________
Yes No
Yes No
_____________________________
Yes No
Yes No
_____________________________
Yes No
Yes No
_____________________________
Yes No
Yes No
_____________________________
Yes No
Yes No
_____________________________
Yes No
Yes No
Yes No
Yes No

2-4
Procedures for CoaguChek XS Operator Training and Evaluation
Operator Training/Certification
For our anticoagulation management program, CoaguChek XS operators have documented
training for the tests that they are authorized to perform. Roche representatives may provide this
training during installation of the CoaguChek XS System. After the training session, a
CoaguChek XS Operator Certification Checklist (FORMS Section) is completed for each
operator. Keep a copy of the CoaguChek XS Operator Certification Checklist for at least 2
years.
When additional operators must be trained after the initial CoaguChek XS System installation,
the anticoagulation management program director, a current operator (under the anticoagulation
management program director’s supervision) or a Roche representative can provide this
training.
Use the CoaguChek XS System Training DVD as the basis of the training session. This
program runs approximately 15 minutes and provides step-by-step instructions for setting up the
meter, preparing for and performing a blood test, and cleaning the meter.
Familiarize operators with the contents and structure of:
The CoaguChek XS System User Manual.
The CoaguChek XS System Getting Started Guide.
Package inserts for test strips and instructions for lancets.
If you need additional copies of the training materials, you may download them at
www.coaguchek-usa.com
Document personnel training on the CoaguChek XS Operator Certification Checklist (behind
FORMS Section). Keep training records for at least 2 years or for the life of the instrument,
whichever is longest.
After initial training, CoaguChek XS operators must carefully follow the instructions for test
performance and troubleshooting (found in this Policies & Procedures Manual and also in the
CoaguChek XS package insert and CoaguChek XS User Manual).
For institutional settings where several operators are trained on several shifts, a suggested in-
service curriculum follows.
Suggested In-service Curriculum
The following framework is suggested to help you plan training time, determine class size and
provide optimal conditions for the practice portion of the training. Plan to have sufficient space,
time, and one-on-one coaching during the training session. Repeated exposure to a consistent
message and hands-on practice are keys to successful training.
Select a space for training that is free of distractions and which has adequate space for
operators to take notes, to practice with the meters, and to see the video screen. Plan on at
least one and a half hours for the session, in order to allow plenty of time for operators to
practice the testing procedure and to ask questions. Keep in-service classes small so that each
operator can receive individual attention during the practice session if needed.

2-5
Before the in-service begins, program the CoaguChek XS meter with the time, date, and result
format (INR, seconds, or %Quick).
Instructors
The instructor may be a Roche representative, a nursing supervisor or quality assurance nurse,
or another designated individual who has been trained on the CoaguChek XS System. It may be
helpful to have one or more assistants, especially during the practice session, to allow the
instructor to maintain class momentum.
Training Materials
Have one of each available in the training space:
CoaguChek XS System Training DVD. This program runs approximately 15 minutes,
provides step-by-step instructions for setting up the meter, preparing for and performing
a blood test, and cleaning the meter. This DVD is intended to be the basis of the training
session.
CoaguChek XS System User Manual. This is a reference guide for CoaguChek XS
operators. During training, familiarize the operators with its content and structure.
CoaguChek XS System Getting Started Guide. This is an easy resource for operators.
During the in-service, familiarize the operators with its contents and structure.
Package Inserts for test strips and instructions for lancets. These inserts contain
information about proper storage and use. During the in-service, familiarize operators
with their contents. Remind operators to refer to the latest package insert inside each
container of test strips for the latest information about test performance and
interpretation.
CoaguChek XS Operator Certification Checklist, located in the FORMS Section of
this Policies & Procedures Manual.
CoaguChek XS System Policies & Procedures Manual
If you need additional copies of the training materials, you may download them at
www.coaguchek-usa.com
Supplies
Have at least one complete set of CoaguChek XS System supplies for demonstration purposes:
CoaguChek XS meter (with batteries inserted and set-up options selected)
CoaguChek XS PT Test strips
CoaguChek XS Code chip
CoaguChek Capillary tubes and bulbs for capillary samples (only if used in your facility)
Anticoagulant-free plastic syringes and needles for venous samples (only if used in your
facility)
CoaguChek Lancet or other single use lancet device
Approved cleaning solutions as listed in the user manual
Biohazard waste and sharps containers
Alcohol wipes
Cotton balls or tissue
Disposable gloves
Organize teaching supplies and test electronic equipment before the in-service. You need:
CoaguChek XS System Training DVD
DVD player

2-6
Suggested Class Outline
This outline will help operators know what to expect and help you pace the class. You may
wish to distribute it as part of your introduction.
Topic
Time to present (minutes)
1. Introduction and overview
5
2. CoaguChek XS System Training DVD
15
3. Test kit, meter and components
10
4. Operating guidelines
5
5. Performing the test
30
Setting up the system
Collecting and applying a sample
Reading, responding to, and recording patient
test results
Practicing and confirming
6. Cleaning the system
5
7. Troubleshooting
5
8. CoaguChek XS Operator Certification Checklist,
Operator Certification Test (see FORMS
Section)
10
9. Q&A, conclusion
5
Approximate total time:
1 hour, 30 minutes
1. Introduction and Overview (about 5 minutes)
Begin the class by introducing yourself and your assistant. Ask operators to
introduce themselves.
Review the class outline and tell participants what will be expected of them, and how
they will be evaluated.
Review the criteria for completing the course:
–CoaguChek XS Operator Certification Checklist
–Operator Certification Test
Ask for questions.
2. CoaguChek XS System Training DVD (about 15 minutes)
The CoaguChek XS System Training DVD provides an overview of the system,
setting up the meter, testing procedure, and maintenance. These topics will be
covered in depth during the remainder of the training session.
Show the CoaguChek XS System Training DVD.
When the DVD is over, ask for questions. Address any concerns that will not be
explicitly covered in class. If operators ask questions about material that will be
covered, respond briefly, and assure them that they will get a detailed answer later.
3. Test Kit, Meter and Components (about 10 minutes)
Review these components with participants.

2-7
Component
Description
CoaguChek XS meter
A portable coagulation meter for PT/INR testing.
4 AAA batteries
The meter’s power source.
CoaguChek Lancets with
instructions
Devices used to obtain fingerstick blood sample for
testing.
CoaguChek XS System User
Manual
A detailed resource manual for CoaguChek XS System
operators.
CoaguChek XS System Getting
Started Guide
A resource of key information for CoaguChek XS System
operators.
CoaguChek XS System Policies
& Procedures Manual
A detailed Policies and Procedures Manual for evaluation
and use of the CoaguChek XS System.
CoaguChek XS Meter Elements
Show participants each of the following elements on a CoaguChek XS meter:
Side
Description
Code chip slot
Insert code chip here
Set button
Used to change settings on meter
Front
Description
Display
Shows results, information, symbols and results recalled
from memory.
ON/OFF button
Press and hold until the meter turns on or off.
Test strip guide
Insert test strip here.
Test strip guide cover
Remove to clean the test strip guide.
Back
Description
Battery cover and tab
Covers the battery compartment.
Press tab to slide cover off.
Roche Diagnostics Technical
Service Center
Call 1-800-428-4674 for technical service 24 hours a day,
7 days a week.
CoaguChek XS PT Test Strip
Show each of the following components:
Component
Description
CoaguChek XS PT Test strip
Provides a platform for the blood and reagents to react.
Target area of the Test strip
Apply blood sample here.
CoaguChek XS PT Test strip
Calibrates the system for each new box of test strips.
code chip
CoaguChek XS PT Test Strip
Insert
Provides important reference material on how to use and
store the test strips.
4. Operating Guidelines (about 5 minutes)
Stress the importance of this information to participants, ensuring that they understand that
test results may not be accurate if they do not strictly adhere to these conditions.
Carry the meter in a well-protected case.

2-8
Explain the proper conditions for operating the meter:
–At temperatures between 59°F and 90° F (15°C and 32°C) in areas without
condensation.
–In artificial light or indirect sunlight. (Avoid bright sunlight.)
–On a level, vibration-free surface or hold it so it’s roughly horizontal.
–At altitudes no higher than 14,000 feet (4,300 meters).
–Away from strong magnetic fields, such as microwave ovens, which may
interfere with proper operation of the meter.
Explain how to store and handle test strips:
–In their container with the cap tightly closed.
–At room temperature or in the refrigerator (2°C to 30°C or 36°F to 86°F). Do
not freeze test strips.
–When stored properly, the test strips can be used until the expiration date
printed on the test strip container. Dispose of test strips that are past their
“Use By” date.
5. Performing the Test (about 30 minutes)
Turn the meter on.
–Explain that CoaguChek XS meter can operate only with four alkaline-
manganese AAA batteries.
–Show participants the battery symbol on the meter display. The battery
symbol is divided into four segments. With new, fresh batteries in the meter,
the battery symbol shows all four segments. When only one segment
appears, replace the batteries. When only one segment appears you can still
access results stored in the meter’s memory. If you insert new batteries within
1 minute of removing the old batteries, the date and time settings will remain
in memory. But if you do need to reset the date and time, refer to the Meter
Setup section in the CoaguChek XS System User Manual.
–To save power, the CoaguChek XS meter automatically turns itself off after
three minutes, unless a button is pressed or test strip is inserted.
Allow an operator to practice changing the batteries:
–With the meter OFF, press the battery compartment cover release tab and
slide cover off.
–Insert four (4), AAA batteries as indicated by the diagram inside the battery
compartment.
–Slide the battery compartment cover back onto the meter and close it.
Using the Test Strip Code Chip
Explain that each box of test strips comes with its own code chip. The code chip
provides the meter with information such as the lot number and expiration date of the
test strips.
Have operators follow these steps to match the code chip to the test strip:
–Before each test, make sure the correct code chip is in the meter.
–The 3-number code on the test strip container must match the 3-number
code on the code chip.
–Show operators how to install the code chip.
–Explain that if the code chip is missing or incorrectly inserted, error messages
appear in the display. (Refer to Error Messages in the CoaguChek XS
System User Manual.)

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Set-up Options
Explain the display options for the CoaguChek XS meters used in your facility
(INR,Seconds, and %Quick)
Collecting the Sample
Gather supplies listed previously and show participants how to perform a capillary
fingerstick (using either the direct drop method or using the capillary bulb) and how
to place the sample on the test strip.
If your facility will be performing venous draws, address venipuncture technique in
this section too.
Testing a Patient Sample
Place the meter on a flat surface, free of vibrations (or hold it in your hand so the
meter is roughly horizontal). Take a test strip out of the container. Wearing
disposable gloves and washing hands before and after testing, demonstrate how to
perform a patient test.
Reading Results
Results appear on the meter’s display immediately after the test.
Results are also stored in the meter’s memory:
–The CoaguChek XS meter stores the most recent 300 test results along with
the time and date. When reviewing memory, the most recent result is
displayed first. If the memory is full when you perform a test, the oldest result
is automatically deleted. The most recent result is always saved.
–Review the following steps to recall patient test results that are stored in
memory:
1. Press the Mbutton. The meter turns on, if it is not already on, and goes to
the Memory mode.
2. The most recent test result appears. The letters mem indicate you are
viewing a result in memory. If there are no results in memory, a 0appears
in the top right corner.
3. Use the Mbutton to scroll through the meter’s memory.
4. Turn the meter OFF.
When viewing results in memory, results can be changed between INR and Seconds
by pressing the “Set” button on the side of the meter. This will allow the user to
toggle back and forth between seconds and INR.
Responding to Results
Discuss expected values and that providers determine the best PT level for a patient
depending on the reason for anticoagulant treatment and how each individual
responds to treatment (based on prothrombin time).
Discuss the < 0.8 INR or > 8.0 INR message, which indicates that the test result is
outside the measuring range for that lot of test strips.
–Explain that if the < 0.8 INR or > 8.0 INR message appears and test was
performed within the Limitations of Procedure as outlined in the CoaguChek
XS PT Test Insert, repeat the test. If the result is still out of range, follow your
facility policy for unexpected results (call to provider).
Review error messages, their causes, and the appropriate action with operators.

2-10
Recording Results
Instruct operators to record the PT result on the appropriate documentation log for
your facility.
Practicing and Confirming
Allow operators ample time to practice the entire testing process: running patient
samples, reading and recalling results, responding to results and recording results.
6. Cleaning the System (about 5 minutes)
Explain that it is important to keep the meter clean. Advise participants to clean the
meter whenever it looks dirty, or whenever stipulated by your facility (if your facility
has a regular cleaning schedule).
Show participants how to check the test strip guide regularly for signs of soiling.
Show participants how to decontaminate the test strip guide (which is potentially
infectious) if it has become soiled with blood or any other material according to the
instructions in the User Manual.
Caution participants never to spray any cleaning solution on the CoaguChek XS
meter, as this may enter the meter and damage it.
Advise participants to decontaminate the CoaguChek XS meter before shipping or
disposal.
7. Troubleshooting (about 5 minutes)
Explain that the occasional testing problem can be solved through referencing the
User Manual, while more extensive problems may require the help of Roche
Diagnostics Technical Service at 1-800-428-4674.
Explain that for most problems, the meter will display an error message.
Show participants the Error Messages chapter of the CoaguChek XS System User
Manual that details potential causes for each message and appropriate action.
8. CoaguChek XS Operator Certification Checklist, Operator Certification Test (about 10
minutes)
Distribute the Operator Certification Test (FORMS Section) and ask participants to
complete it. This will determine whether they have understood key concepts and
uncover potential areas of confusion.
Collect tests and use the answer key to score the tests.
–Individual instructors determine the criteria for a passing score.
–Require those who do not perform adequately on the Operator Certification
Test to attend a second class.
Complete the CoaguChek XS Operator Certification Checklist for each
participant. Review any areas of confusion with the class.
File each operator’s CoaguChek XS Operator Certification Checklist. State where
these are located: ____________________________________________________.
9. Q & A Session, Conclusion (about 5 minutes)
Question attendees to be certain that everyone is clear on every aspect of testing
and is confident that they can obtain acceptable results.

2-11
Operator Competency Evaluation (Optional)
Operator competency evaluation is required by some accreditation agencies (Appendix A).
In this facility, the anticoagulation management program director may request operator
competency evaluation at any time, and will oversee employee retraining if required.
Personnel competence is always assessed when problems are observed or identified during
specimen collection, handling, testing or reporting test results.
Assess operator competency by visual observation to ensure that written procedures are
followed. Another way to assess personnel competency is by requiring an operator to perform a
test on a patient sample, followed by another (problem-free) operator performing a test on that
same patient. Test results should be almost identical.
Use the CoaguChek XS Operator Evaluation Checklist (FORMS Section) to document
operator competency. If retraining is required, document it on the CoaguChek XS Operator
Certification Checklist and re-evaluate the operator. Document this on the CoaguChek XS
Operator Evaluation Checklist.
Document personnel concerns and corrective action pertaining to personnel on the Monthly QA
Checklist (behind FORMS Section). If problems with personnel competency persist, these
personnel procedures may be changed to require more frequent personnel training or ongoing
periodic re-evaluation.