Roche CoaguChek XS Procedures Manual
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Roche CoaguChek XS Procedures Manual

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See also: Training Manual , User Manual
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

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  • Page 1  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.

  • Page 2: Table Of Contents

    Campell 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 Program 1- SAM Program Director ....................... 1-2 Individuals Involved in the SAM Program...................
  • Page 3 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...
  • Page 4 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 ...........................

  • Page 5: Getting Started With The Coaguchek Xs System

    Section 2 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. Step 4: Read this Manual and fill-in-the-blanks to indicate your exact procedures This Policies &...
  • Page 6 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: ___________________...

  • Page 7: Section 1: Systematic Anticoagulation Management (Sam) Program Overview

    ____________________________________________________________________________ ____________________________________________________________________________ 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.

  • Page 8: Sam Program Director

    The program director ensures that only certified operators perform testing on the CoaguChek XS meters. Individuals Involved in the SAM Program...

  • Page 9: Policies And Procedures For The Sam Program

    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 –...

  • Page 10: Section 2: Personnel Training Policies And Procedures

    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.”...

  • Page 11: Operator Qualifications

     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...
  • Page 12 _____________________________ _____________________________ _____________________________ _____________________________ _____________________________ _____________________________...

  • Page 13: Procedures For Coaguchek Xs Operator Training And Evaluation

    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.

  • Page 14: Coaguchek Xs System Training Dvd

    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.
  • Page 15 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.

  • Page 16: Operating Guidelines

    A detailed Policies and Procedures Manual for evaluation & Procedures Manual 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...

  • Page 17: Performing The Test

    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.
  • Page 18 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.

  • Page 19: Practicing And Confirming

    User Manual.  Caution participants never to spray any cleaning solution on the CoaguChek XS meter, as this may enter the meter and damage it. ...

  • Page 20: Operator Competency Evaluation (Optional)

    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.

  • Page 21: Section 3: Method Comparison (Optional)

    CoaguChek XS System performs as well in their setting as the manufacturer claims before instituting the method. Another reason for comparing a new method to the previous method is to assist physicians in interpreting test results from the new system.

  • Page 22: Sources Of Error In Method Comparison Studies

    Record the result from the CoaguChek XS meter on the Method Comparison Log (FORMS Section). For the purpose of this study, repeat any CoaguChek XS PT Test result greater than 4.0 INR with a fingerstick sample from the opposite hand. Place the second result in parentheses after the first result in the Method Comparison Log.

  • Page 23: Section 4: Safety In The Testing Area

    Wear rubber utility gloves when cleaning.  If the exterior of the CoaguChek XS meter is visibly soiled with blood, clean with approved solutions as listed in the user manual. Safety Precautions for Working with Potentially Infectious Material Consider all patient specimens to be potentially infectious.

  • Page 24: Hazardous Waste Disposal

    Wear gloves whenever you: Collect specimens (fingerstick or venipuncture) or touch patients’ mucous membranes or  open wounds.  Touch items or surfaces soiled with blood or body fluids.  Are in the testing area and have cuts, scratches, or breaks in your skin. Wash hands: ...

  • Page 25: Section 5: Preanalytic Policies And Procedures

    Test requisitions must include the patient’s full name, age or date of birth, gender, source of specimen and time of collection. If a verbal test order is given to a CoaguChek XS operator, the patient chart or a written test requisition will be generated by the end of the day. Check one: ...

  • Page 26: Fingerstick Blood Collection Procedure

    The minimum sample size is 8 µL of whole blood.  For PT/INR testing on the CoaguChek XS system, do NOT wipe away the first drop of blood. ...

  • Page 27: Venipuncture Procedure

    2. Select the appropriate collection supplies  Use a plastic syringe with no additives or anticoagulants for collection of venous samples for testing on the CoaguChek XS system. Use at least a 23-gauge needle or larger in size.  Remove a CoaguChek XS PT Test strip from its container and immediately re-cap the container shortly before performing the venipuncture.

  • Page 28: Specimen Handling

    Do not accept samples collected from the arm receiving the infusion line from patients who are on intravenous infusion therapy.  Do not use the CoaguChek XS meter for testing patients being treated with any direct thrombin inhibitors, including Hirudin, Lepirudin, Bivalurudin, Argatroban, and Dibigatran etexilate.
  • Page 29  Do not perform a test on any specimen that is unsuitable for analysis. Either notify the ordering provider or re-collect the specimen from the patient.

  • Page 30: Section 6: Analytic Policies And Procedures

    If the date and time are not set (after turning the meter on for the first time or because the batteries were removed from the meter for more than 1 minute), the CoaguChek XS System will not perform a test. Rather, turning on the meter takes you immediately to the SETUP mode, where you must set the date and time.

  • Page 31: Code Chip Storage And Stability

     Use the strip within 10 minutes after removing it from the container.  When stored and used properly, CoaguChek XS PT Test strips are stable until the “Use By” expiration date.  Discard the strips if they are past the “Use By” date. Do not use expired strips.

  • Page 32: Ordering Test Supplies

    Allow wiped areas to dry for at least 10 minutes before performing a test. Cleaning/disinfecting the meter test strip guide  Use only 70% isopropyl alcohol or 10% bleach solution to clean the CoaguChek XS test strip guide.  Do not use any other cleaning/disinfecting solutions on the test strip guide. Use of other cleaning/disinfecting solutions could result in damage to the meter.

  • Page 33: Onboard Quality Controls

    Quality Control (QC) checks the accuracy and precision of the analytical process and helps detect immediate errors, performance over time, and variance in operator performance. The CoaguChek XS System has a number of built-in quality-control functions that control the entire analytical process: ...

  • Page 34: Procedure For Performing Patient Tests

    Keep it available for CoaguChek XS operators, if they do not use the following procedure on a daily basis. If changes occur on a package insert, make changes in the procedure below and remove old package inserts.

  • Page 35: Turnaround Time

    13. The result is displayed in the unit of measure you chose when setting up the meter. It is automatically saved to memory. 14. Read and record results on the CoaguChek XS Testing Log. 15. Remove the test strip from the measurement chamber.
  • Page 36  Apply a capillary sample to the test strip within 15 seconds of the fingerstick.

  • Page 37: Limitations Of The Procedure

    Limitations of the Procedure  Do not use the CoaguChek XS System for testing patients being treated with any direct thrombin inhibitors, including Hirudin, Lepirudin, Bivalurudin, Argatroban, and Dibigatran etexilate. The blood sample must be at least 8 μL. Low sample volume will cause an error ...

  • Page 38: Section 7: Postanalytic Policies And Procedures

    ____________________________________________________________________________. Reportable Ranges (Operating Ranges) The operating ranges listed below are the ranges over which the CoaguChek XS System displays and transmits results. If a result of < 0.8 INR or > 8.0 INR is displayed, the test result could not be measured or the result may be outside the measuring (reportable) range for the particular lot of test strips.

  • Page 39: Interpreting Results

    Interpreting Results The CoaguChek XS meter displays test results in units equivalent to laboratory plasma measurements. If the meter displays a message other than a result, refer to the Error Messages section of the CoaguChek XS System User Manual. Recognizing Unusual or Clinically Inconsistent Results Once a result is obtained, consider: ...

  • Page 40: Recording And Reporting Results

    Recording and Reporting Results Record results for each patient on the CoaguChek XS Testing Log (behind FORMS Section) as you read the results. If test results are also written onto the patient chart, include the name of the test, the test result and unit of measure, the date the test was performed, and the initials of the testing personnel as well as the test result.

  • Page 41: Ensuring The Security Of Patient Test Results

    At the ordering physician’s request or when there is a concern that the results obtained from the CoaguChek XS System may be questionable, or if the CoaguChek XS System is otherwise unavailable for use, specimens may be referred out to a CLIA-certified laboratory. Note on the test report that the specimen was sent out for testing.

  • Page 42: Procedure For A Power Failure

    Procedure for a Power Failure The CoaguChek XS meter can operate only with four AAA batteries. The batteries should last for up to 2 years or 300 tests, depending on the type of battery used. Therefore, a power failure will not affect the CoaugChek XS meter.

  • Page 43: Section 8: Quality Assessment

    Note: Proficiency testing is not required by the federal CLIA regulation for the CLIA-waived CoaguChek XS System. However, some states, such as Maryland and Pennsylvania that do not recognize the federal CLIA waived test category, require an external measure to assess external quality of testing.
  • Page 44 If you performed method comparison, use the same referral laboratory for split sampling. This is because the bias between that method and the CoaguChek XS System has already been established. Be sure this laboratory can test split samples within 4 hours of collection.

  • Page 45: Sources Of Error In Split Sample Studies

    Some inherent sources of error in split sample studies include differences in specimen collection between testing performed routinely on the CoaguChek XS System and the way specimens must be collected for the split sample analysis. Split sample sources of error are identical to...

  • Page 46: Section 9: Forms

    Use if periodic competency assessment of Evaluation Checklist operators is requested. (Optional) CoaguChek XS Method Use to compare a new CoaguChek XS System Comparison (Optional) with a previous method (optional). CoaguChek XS Patient Test Fill out for each patient tested.

  • Page 47: Coaguchek Xs Operator Certification Checklist

    COAGUCHEK XS OPERATOR CERTIFICATION CHECKLIST Operator Trainee: __________________________________ Date: ____________ General  Describe the intended use of the instrument.  Review all manuals and reference materials (User Guide, package inserts, Policies & Procedures Manual) Sample Handling  Review the requirements for specimen collection, sample handling, and processing.

  • Page 48: Operator Certification Test

    Date: ______________ Mark “T” (true) or “F” (false) 1. When coding the CoaguChek XS meter, you must use the code chip with the same number as that printed on the label of the test strip vial you are using. 2. After removing the test strip from the container, it is important to close the cap tightly.
  • Page 49 Operator Certification Test Answer Key 1. T 2. T 3. T 4. T 5. T 6. F – International Normalized Ratio 7. T 8. F – If the built-in quality control does not pass, a flashing “QC” will appear on the display. 9.

  • Page 50: Coaguchek Xs Operator Evaluation Checklist (Optional)

     Correctly recalls results stored in memory  Solves Problems Refers to Error Messages in CoaguChek XS System User Manual when a problem occurs  Knows when to call the 24-hour Roche Technical Service (800-428-4674)  Contacts the appropriate person when questions arise concerning testing or reporting ...

  • Page 51: Coaguchek Xs Method Comparison Log (Optional)

    Controls Operator Date Result Result Average Referral Lab Results = _____ Average CoaguChek XS Results = _____ *Average of Method 1 minus Average of Method 2 = Bias Factor Bias Factor: _____________ Comments: __________________________________________________________________ Program Director Approval: __________________________ Date: __________________...

  • Page 52: Coaguchek Xs Patient Test Log

    COAGUCHEK XS PATIENT TEST LOG CoaguChek XS Meter Serial Number (if more than one meter used in this facility): ______________________________________ Date/Time Test Strip Controls Specimen Patient Name Patient ID# Test Results Operator Lot Number (OK?) Collected/Tested...

  • Page 53: Monthly Qa Checklist

    Is a Checklist present for each CoaguChek XS system operator? Check the Policies and Procedures Approval Form: Have all CoaguChek XS operators read and signed this form on page ii? Has the current anticoagulation management program director approved the CoaguChek XS procedure? Have any changes made to the Policies &...

  • Page 54: Split Sample Log (Optional)

    Comments: __________________________________________________________________ ____________________________________________________________________________ * Attach referral lab results to this form, if applicable. **Use the following formula to calculate percent deviation: CoaguChek XS result minus comparison lab result X 100 = % deviation comparison lab result Program Director Approval: __________________________...

  • Page 55: Section 10: Appendices

    SECTION 10: APPENDICES Appendices Index Appendix When to Use Page # A. Regulations Governing For more information about CLIA regulations, state 10-2 laboratory regulations, and accrediting agency Testing requirements. B. Joint Commission These goals are mandatory for facilities accredited by 10-5 Joint Commission.

  • Page 56: Appendix A. Regulations Governing Testing

    2. Moderate complexity, including the subcategory Provider Performed Microscopy (PPM) 3. High complexity The CoaguChek XS falls into the CLIA waived category. Those facilities that perform only CLIA waived tests are required to: 1. Possess a valid CLIA certificate (see below for instructions to complete the form to obtain such a certificate).
  • Page 57 If your facility needs to apply for a CLIA certificate, follow these easy steps: STEP 1: Call your state CMS office (see list on previous page) and ask for Form CMS-116 and any additional forms that may be required in your state to either register a new laboratory for a certificate of waiver.
  • Page 58 State Regulations That Differ From the Federal CLIA Regulations Certain states have regulations that exceed the Federal CLIA regulations for certain kinds of testing facilities. Contact your state department of health for any state-specific requirements. 10-4...

  • Page 59: Appendix B. Hospital: National Patient Safety Goals

    APPENDIX B. HOSPITAL: NATIONAL PATIENT SAFETY GOALS For the most current national patient safety goals, -refer to The Joint Commission publication, National Patient Safety Goals for Hospital Accreditation Program, available online at: http://www.jointcommission.org/ 10-5...

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