ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 1 ® CoaguChek XS System Professional Training Manual for Self-Testing
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 2 Table of Contents Introduction............................................................................................................... 1 1 Overview of Warfarin Therapy and the CoaguChek XS System..................... 3 2 Materials for User Training .................................................................................... 5 3 4 User Selection Guidelines.........................................................................
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page ii Introduction Introduction Roche Diagnostics is pleased to present this guide to assist you in training individuals in the use of the CoaguChek® XS System.
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 2 1 Overview of Warfarin Therapy and the CoaguChek XS System OVERVIEW The CoaguChek XS System from Roche Diagnostics measures blood-clotting time for people who are taking anticoagulation medications such as warfarin (for example Coumadin®). Warfarin is an oral anticoagulant that changes the formation of certain blood factors produced in the liver in such a way that the clotting time is slowed.
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 4 2 Materials for User Training Roche Diagnostics has developed the following materials, provided in the product care kit, specifically for your use in training new users to self-test with the CoaguChek XS System: Training DVD This program, which runs approximately 15 minutes, provides step-by-step instruction in setting up the meter, preparing for and performing a fingerstick blood test, running quality control checks, and cleaning the meter.
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 6 3 User Selection Guidelines OVERVIEW It is important that users be screened carefully before beginning a self-testing program. The following questions are designed to guide the physician, clinic nurse, or other healthcare professional in determining an individual’s suitability for self-testing. Are specific diagnoses more No, the specific diagnosis is not necessarily indicative of who should or should appropriate for self-testing? not self-test.
ROC270037 34690 CoagXS PT Mn 1F 3 4/18/07 8:05 AM Page 8 User Selection Guidelines Once the potential user has passed the initial screening, what do we do next? Clinical Study Information 8 User Selection Guidelines Explain to the person in general terms what will be involved and provide an opportunity to ask questions. If he or she expresses interest, send a copy of the training DVD home or show it in the office.
ROC270037 34690 CoagXS PT Mn 1F 3 4/18/07 8:05 AM Page 10 User Selection Guidelines User Selection Guidelines 10 9 8 Precision: N = 297 PB: y = 1.154x - 0.2 Slp CI (1.111,1.198) Int CI (-0.3, -0.2) Correlation = 0.934 7 6 5 4 3 2 1 0 A study was conducted and the precision of duplicates for capillary blood results was calculated for both trained users and healthcare professionals. The following results were obtained: N Mean SD CV 0 1 2 3 4 5 6 7 8 9 10 3 User Results 214 2.57 0.
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 12 4 Training Users for Self-Testing PREPARATION The suggested time for each training session is two hours. If you prefer, you may break this into two one-hour sessions. Some trainers have found that it works well to have one educational session and one hands-on practice session. However the training is scheduled, it is important to allow plenty of time for trainees to practice the testing procedure and ask questions. Training is mandatory.
ROC270037 34690 CoagXS PT Mn 1F 4 4/18/07 8:05 AM Page 14 Training Users for Self-Testing Training Users for Self-Testing • CoaguChek XS System Test Kit, consisting of: • A container of test strips Introduction and Overview of Training Session 1. Explain the importance of regular PT/INR testing. 2. Review the policy for certification. Explain that each trainee will be asked to successfully complete a Knowledge Test and Skills Checklist.
ROC270037 34690 CoagXS PT Mn 1F 4 4/18/07 8:05 AM Page 16 Training Users for Self-Testing Training Users for Self-Testing 3. Review operating conditions of the meter and proper storage conditions of test strips • Operate meter at room temperature, 65˚ to 90˚ F (18˚ to 32˚ C). • Operate meter with 10% to 85% relative humidity, without condensation. • Avoid bright sunlight. • Operate the meter on a flat surface, free of vibrations. • Use well-protected carrying case.
ROC270037 34690 CoagXS PT Mn 1F 4 4/18/07 8:05 AM Page 18 Training Users for Self-Testing Training Users for Self-Testing 5. Review collecting and applying the sample, instructing the user to follow this process: 4 the user is to do if the doctor is not immediately available. The user’s doctor should write these immediate follow-up values and follow-up instructions in the appropriate section of the user’s Log Book. • Massage the finger from the base until there is increased color in the fingertip.
ROC270037 34690 CoagXS PT Mn 1F 4 4/18/07 8:05 AM Page 20 Training Users for Self-Testing Training Users for Self-Testing 4 CERTIFICATE OF COMPLETION To clean the test strip guide: 1. Open and clean the cover. With the meter turned off, use your thumbnail to open the cover of the test strip guide by pressing its front edge upward. Move the cover safely away from the meter. Then rinse the cover with water or wipe it clean. 2. Clean the test strip guide.
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 22 5 Proficiency Checks After completing the training class and beginning self-testing, users should be monitored periodically by a trained healthcare professional to be sure their testing technique is correct and the meter is performing properly. Suggested frequency for monitoring is every six months. The following procedure may be useful: • Establish a reminder system that prompts you to contact each user at 6-month intervals.
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 24 6 Forms Follow-up for People Who Are Self-Testing OVERVIEW Introduction The following forms are included as part of the CoaguChek XS System training for self-testing. These forms should be used as originals. Please feel free to copy them as needed.
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 26 COAGUCHEK XS SYSTEM SKILLS CHECKLIST Trainer should check each activity as it is demonstrated or described.
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 28 COAGUCHEK XS SYSTEM KNOWLEDGE TEST COAGUCHEK XS SYSTEM KNOWLEDGE TEST 12.
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 30 ® CoaguChek XS System ANSWER KEY For CoaguChek XS System Knowledge Test 1. T 2. T 3. T Certificate of Completion presented to 4. F – The sample must be applied to the test strip within 10 minutes of removing the strip from the container. 5. T 6. T for successfully completing Self-Testing training on the 7. F – If the built-in quality control does not pass, a flashing “QC” will appear on the display. CoaguChek® XS System 8. T 9. T 10.
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 32 Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 www.coaguchek.
