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User Manual - Drug testing supplies from CLIA waived,Inc, drug tests

1. mi Results in the chosen unit H BHH eomme Error numbers Memory contains no results or no fu results BB BB Displa HH AX BB BH BH v e an format The monitor is in Setup Mode set d Indicates the code number of the code chip code inserted in the meter Result in the chosen unit is above the gt measuring range lt Result in the chosen unit is below the measuring range 52 Symbol Meaning Battery status When the batteries still have their full charge all segments are lit Individual segments disappear one by one as the batteries become weaker When there is no segment remaining you can no longer perform a test You can pever still access the meter s memory The meter is in Memory Mode ic quality control completed successfully Reports an error see Error messages Room or meter temperature is outside the E acceptable range E Communication is taking place via the infrared interface X Measurement chamber cover is open Es 59 54 Warranty CoaguChek XS Meter Limited 1 Year Warranty ROCHE DIAGNOSTICS warrants to the original purchaser only that the meter shall be free from all defects in material and workmanship for a period of one year from the date of purchase Purchaser s sole and exclusive remedy with respect to the CoaguChek XS meter and parts thereof shall be the repair and or replacement of the
2. Note and document quality control results and perform instrument cleaning when needed Follow established corrective actions whenever QC or patient test results are not within the established acceptable levels of performance Identify problems or factors that may adversely affect test performance or reporting of results and either correct the problem or notify the anticoagulation management program manager or director Document all corrective actions taken when problems occur Report concerns of safety and quality of patient testing to the Anticoagulation management program director Report device related adverse events to FDA s MedWatch In this facility the following personnel are authorized to Y C att testing Cs Review to Report Testing analyst tor Results d ti circle one 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 Yes No Yes No Yes No Yes No Yes No Yes No 2 2 Procedures for CoaguChek XS Operator Training and Evaluation Operator Training Certification For our anticoagulation management program CoaguChek XS operators must 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 the CoaguChek XS Operator Certification Checklist and Operator Certification Test are completed for each operator Keep a cop
3. Other Information Ordering Information for H Product Limitations Product Specifications Support Services Symbols WAR AIL cece eis atest cata et ccs tre enrages About this Manual Symbols and Abbreviations The test strip insert the label on the back of the meter the User Manual and other packaging material may contain the following symbols or abbreviations BS Use by Expiration date LOT Lot nu SM cQ C ows This product fulfills the requirements of Directive 98 79 EC on in vitro diagnostic medical devices REF Catalog number m Please read instructions for use Caution refer to accompanying documents Please refer to safety related notes in the manual accompanying this instrument Manufacturer E pb Store at User Resources Several resources are available to help you use and maintain the CoaguChek XS System Video DVD Format The CoaguChek XS System Video is for new users of the CoaguChek XS System The video will help you get comfortable with the CoaguChek XS Meter and the testing procedure Getting Started The Getting Started guide shows you how to perform your first coagulation test on the CoaguChek XS Meter User Manual This CoaguChek XS Syste to the meter and test strip your questions about the entire manual carefully an ensiye guide sW rs to ead this it as necessary Test Strip Pac
4. 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 Performing the Test about 30 minutes Turn the meter on Explain that CoaguChek XS meter can operate only with four alkaline AAA batteries Show participants the battery symbol on the meter display The battery symbol is divided into four segments With new fr shRatteries i in the meter the battery symbol shows all four segments Wheg only one segment zd ars you can still appears replace the batteries When SO access results stored in the me a vore new batteries within 1 minute of gemo the and time settings will remain i t if o Al e date and time refer to the Meter e CoaglC b XS System User Manual CoaguChek XS meter automatically turns itself off after three 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
5. A puncture wound from an item contaminated with blood Wearing gloves and washing hands are the two most important infection control measures to prevent bloodborne pathogen transmission 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 After removing gloves Before touching your eyes or mouth Immediately if a specimen or reagent has been spilled on your bare hands Before eating drinking or smoking Hazardous Waste Disposal OSHA s bloodborne pathogens standard 1910 1030 defines biohazardous waste as Liquid or semi liquid blood or other potentially infectious materials contaminated items that would release blood or other potentially infectious materials in a liquid or semi liquid state if compressed items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling contaminated sharps and pathological and microbiological wastes containing blood or other potentially infectious materials M Examples of Biohazardous Waste f Qi waste Gauze bandage saturated with Blood a p d on a bandage Exam gloves ted with Sloo am gloves not visibly contaminated Sharps coner philebotomylsupplies Used CoaguChek PT Test
6. 0 03 Figure 3 Coaguchek XS Data from Sites 1 2 and 3 Bias Plot for Lot 022 with Capillary Blood 3 0 2 5 2 0 Bias e INR Range 2 0 4 5 Overall N 422 N 701 i 0 Outliers 0 Mean Bias 0 05 1 Outliers 0 2 1 Outliers 0 1 Mean Bias 0 04 Mean Bias 0 03 3 4 5 6 7 8 9 Dade Innovin INR e CR ER Figure 4 shows the bias plot comparing the CoaguChek XS System capillary results to Dade Innovin Sysmex results This graph shows the mean bias for INR results the overall mean bias was 0 04 Figure 4 Coaguchek XS Data from Sites 1 2 and 3 Bias Plot for Lot 022 with Venous Blood Bias R Range 2 0 4 5 Overall N 427 N 713 0 Outliers 0 1 0 Outliers 0 0 Outliers 0 Mean Bias 0 04 Mean Bias 0 06 Mean Bias 0 04 Dade Innovin INR CONCLUSION Prothrombin Time testing is not standardized across systems whether they are lab instruments or portable point of care monitors and there is no defined gold standard for acceptable performance However in this comparison study regression statistics yielded correlation coefficients of 0 97 or greater for all comparisons The Coefficients of Variation presented for precision of whole blood duplicates indicate that the pre cision of the CoaguChek XS monitor for both capillary and venous whole blood samples is very good These results and the findings of several independent studies support the fact that point of care
7. ISI MNPT CoaguChek XS System Serial Number Test Strip Lot Exp Date Patient on Referral Internal a m Warfarin Lab Controls iip od x3 Operator YIN Result OK 1M ud 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 9 6 COAGUCHEK XS PATIENT TEST LOG CoaguChek XS Meter Serial Number if more than one meter used in this facility Date Time Specimen Collected Tested Patient Name Patient ID Test Strip Controls Lot Number OK Test Results Operator 1M d com uva 9 7 MONTHLY QA CHECKLIST Mark Yes No or N A Not Applicable If you answer No to any item explain on the reverse Check CoaguChek XS Operator Certification Checklists 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 amp Procedures Manual been are approved signed and dated by the current anticoagulation management program director If any revisions have be
8. Keep all QC records for at least 2 years Indicate where these recor Ag stored QC Record CoaguChek XS Patient Test Log Monthly QA C t Calibration Coding the Meter with the Code Chip The code chip supplied with each box of test strips automatically calibrates the meter for that particular lot of strips The CoaguChek XS System calibration is traceable to the WHO International Reference Preparations 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 In addition every time the meter is turned on it goes through a series of self diagnostic checks The CoaguChek XS System cannot be adjusted externally to fit a certain linearity curve Use the test strip code chip that was supplied with each new test strip container before performing the first test 1 Turn meter off 2 Remove the old code chip if there is one inserted in the meter 3 Insert the code chip that was supplied with each new test strip container into the code chip slot with the printed side facing up until it snaps into place 4 Compare the code number on the display with the number printed on the test strip container If the two code numbers do not match insert the correct code chip in the slot in the meter 5 An error message is displayed if the code chip is missing or incorrectly inserted Refer to the CoaguChek XS User Manual Errors section for
9. Lab Knowledge Trainee has read and signed the Policies amp Procedures Manual Trainee knows how to report patient test results according to written procedures Trainee can recognize system failures unacceptable QC PT and inconsistent or erroneous patient test results Trainee can correctly document corrective actions associated with error messages Trainee knows who to contact in the event of questions concerning testing or reporting Trainee knows how to contact the FDA in the event of a device related adverse event Trainer Name and Title Date 9 2 OPERATOR CERTIFICATION TEST Operator Trainee Date Mark T true or F false 12 13 14 15 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 3 When performing a blood test it is important to hold the finger to the test strip until the meter beeps 4 A venous sample must be collected in a plastic syringe free of anticoagulants 5 Sample must be applied to the test strip within ten minutes of removing the strip from the container 6 INR is a reporting format that stands for International Normalized Result 7 Every time a blood test is performed the meter also performs a built in quality control test 8 Ifthe built in qu
10. Orders Indicate below how standing orders are documented Include how requisitions for standing orders are stored Specimen Collection and Handling Proper specimen collection and handling is essential for reliable CoaguChek XS PT INR test results Personnel who collect blood samples for testing are trained in specimen collection technique during initial CoaguChek XS system training to avoid inadequate samples The specimen collection procedure below must be followed for each patient 5 1 Fingerstick Blood Collection Procedure 1 Select and organize the appropriate supplies in the testing area CoaguChek XS meter CoaguChek XS PT Test Strips and matching code chip CoaguChek Lancet CoaguChek Capillary tube bulb if needed Cotton ball or gauze alcohol wipe and bandage Identify the patient Identify patients by having them or a guardian state their full name and another identifier such as date of birth If more than one patient is present with the same first and last name look for possible gender differences social security number patient identification number birth date different middle name and relevance of the test to the patient s history In this facility the second patient identifier is Explain to the patient the purpose and steps of the procedure Remove a test strip from its container shortly before performing the fingerstick Immediately re cap the container The blood sample must be applied to the test strip
11. PT INR testing with the CoaguChek XS monitor is a viable alternative to drawing a venous sample and sending it the lab in terms of both accuracy of results and the cost effectiveness of care Y IN W A ivedor References T Fourth American College of Chest Physicians Consensus Conference on Antithrombotic Therapy Chest 1995 104 supplement 225S 522S Loeliger EA van den Besselaar AMHP Lewis SM Reliability and Clinical Impact of the Normalization of the Prothrombin Times in Oral Anticoagulant Control Thrombosis and Haemostasis 1985 53 148 154 Giles TD Roffidal L Results of the Prothrombin Office Testing Benefit Evaluation PROBE CVR amp R 2002 23 27 28 30 32 33 Multicenter prospective design study with 1951 patients up to 50 consecutive to assess patient physician and physician office staff satisfaction with an office based finger stick method of PT testing vs the usual method of testing in an outside laboratory Bussey HI Chiquette E Bianco TM et al A statistical and clinical evaluation of fingerstick and routine laboratory prothrombin time measurements Pharmacotherapy 1997 17 5 861 866 Kaatz SS White RH Hill J et al Accuracy of laboratory and portable monitor interna tional normalized ratio determinations Comparison with a criterion standard Arch Intern Med 1995 155 1861 1867 Campbell P Radensky P Denham C Economic analysis of systematic anticoagulation management vs routine medical care f
12. Transport Conditions Temperature range 13 F to 158 F 25 C to 70 C Relative humidity 10 to 85 without condensation Support Services Questions Please call the Roche Diagno nical Service Center at 1 800 428 4674 if you have questions regarding the handling of your meter the reliability of your results or if you suspect the meter is defective Repairs Please note that repairs new settings or other modifications to the meter may only be performed by persons authorized by Roche Diagnostics UA Symbols The following table lists all of the display screen icons and their meaning Symbol Meaning E Test strip without sample application area Tesh grip with sample application area gom ved ser must wait until the meter has completed an action eh 24 hour time format ich 12 hour time format Time between midnight and noon am in 12 hour time format m Time between noon and midnight n in 12 hour time format 0 Indicates the results are displayed as a Q Quick percentage value Indicates the results are displayed in Sec di Seconds INR Indicates the results are displayed in INR units 51 Symbol Meaning n A Beep tone is turned on Beep tone is turned off ri OFF a only with INR as unit Result is below the chosen therapeutic range t Result is above the chosen therapeutic range V only with INR as unit
13. a oa a a o o ooo 0 0 0 00 QOCOOO Mean of Replicates Difference Between Replicates Graph 2 CoaguChek XS System Venous Blood Precision Lot 022 Whole Blood Precision for Venous Blood Lot 2 Mean of Replicates Accuracy Method Comparison The correlation of the results of the CoaguChek XS System lot 022 capillary blood tests to the results of the Dade Innovin Sysmex Analyzer tests is shown in Figure 1 Linear regression n 701 yielded a slope of 1 00 with an intercept of 0 04 The correlation coefficient is 0 976 Figure 1 Coaguchek XS vs Dade Innovin Capillary Data for Lot 022 from All Sites N 701 87 y 1 000x 0 04 oo 4 Slp C I 0 984 1 020 Er a Int C I 0 004 0 07 Correlation 0 976 J CoaguChek XS INR Dade Innovin INR Figure 2 shows the comparison of the CoaguChek XS System lot 022 venous blood results to the Dade Innovin Sysmex Analyzer results Regression analysis n 713 yielded a slope of 1 02 and an intercept of 0 002 The correlation was 0 980 CoaguChek XS INR Figure 2 Coaguchek XS vs Dade Innovin Venous Data for Lot 022 from All Sites N 701 y 1 020x 0 002 Slp C I 1 000 1 037 Int C I 0 024 0 04 Correlation 0 980 Dade Innovin INR Figure 3 shows the bias plot comparing the CoaguChek XS System capillary results to Dade Innovin Sysmex results This graph shows the mean bias for INR results the overall mean bias was
14. an unusual test result other than an error check the following items Check that the correct code chip is in the meter The 3 numb r ES on the test strip container must match the 3 number code on at Qm Check that the meter is set up with the d K xpiration date of the strips is programmed i i o the date on the meter Therefore i orta owes correctly on the meter Debris o trip e t with results Clean the meter as recommeded in uChek XS System User Manual Do e a spray to clean the guide or any part of the meter Do not let liquid enter the meter Refer to Limitations of the Procedure on page 6 6 Critical Alert Action Value Procedures Insert the patient PT INR test values that require immediate notification of the provider Indicate exactly what action your laboratory takes when critical values are obtained Recording and Reporting Results Record results for each patient on the CoaguChek XS Testing Log in 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 Include the calendar year in the date Also if the same test is performed on a patient multiple times in one day include the time of each test Note Never place patient test results on post it notes or pieces of scrap paper that can be misplace
15. 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 8 6 7 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 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 is 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 With gloved hands use a soft lint free cloth or swab moistened with a 10 bleach solution or 70 isopropyl alcohol solution Be sure to wring out the towel or cloth so that it is damp not wet to ensure excess fluid does not enter the meter Excess moisture can dama
16. comparison instrument The CoaguChek XS System results may be consistently lower or consistently higher than the comparison instrument In evaluating results as long as the bias factor remains consistent the split sample verification of results may be considered successful 6 When the split sample study is complete provide results to the anticoagulation management program director The director will determine whether or not a clinically significant difference exists between the two methods and whether or not the results are acceptable 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 those for method comparison and are described further on page 3 2 Maite SECTION 9 FORMS Form When to Use Page CoaguChek XS Operator Once before new testing personnel are allowed 9 2 Certification Checklist to perform the test Operator Certification Test Use when conducting in services for new 9 3 CoaguChek operators Includes test key CoaguChek XS Operator Use if periodic competency assessment of Evaluation Checklist operators is requested 9 5 Optional CoaguChek XS Method Use to compare a new CoaguChek XS System 9 6 Comparison Optional with a previous method optional
17. has a number of built in quality control functions that control the entire analytical process Acheck ofthe electronic components and functions every time the meter is turned on A check of the test strip temperature while a test is in progress A check of the expiration date and lot information on the test strip carried out by the code chip A two level on board quality control test located within the same single test chamber where patient test results are determined Refer to the CoaguChek XS System User Manual for more information about quality control functions and the internal monitoring system Because of these advanced features Roche Diagnostics does not recommend nor provide liquid quality control material with this test system QC Procedures Each Day of Testing With each patient test observe the on board internal QC result and record it on the CoaguChek XS Patient Test Log If acceptable patient test results can be reported Troubleshooting Out of Control QC Results To resolve QC error messages carefully follow the instructions in the User Manual Check that the test was performed exactly as directed and that the test was run within 10 minutes of removing the test strip from its container If troubleshooting is unsuccessful and control results are still unacceptable call Roche Diagnostics Technical Service Center at 1 800 428 4674 Document this on the Monthly QA Checklist FORMS Section QC Record Retention
18. in INR Upper range 2 5 4 5 Default Setting INR On Off 1 5 INR 2 5 INR 37 38 Setting Advanced Features You can access these settings by going to Setup mode To go to Setup mode press the SET button The date format flashing will appear Once you are in Setup mode you ll use these buttons s KT to change a setting to accept a setting and move on to the next setting Note When you go to Setup mode the date format date time format and time settings appear first Press the S tton d to moveggast the tinge settings toget to ti ced settin The Meter s Display When you turn the meter on it briefly shows all the display s letters numbers and symbols Regularly check that all segments of each letter number and symbol appear Please compare your meter s display to the meter display shown here on this page You can display all the letters numbers and symbols for a longer time to allow comparison To do this you will turn the meter on and then hold down the ON OFF button 87 The full display should appear as follows 39 40 Error Messages You may see the following error messages while using the CoaguChek XS Meter If you see an error message first try to correct the problem using the solution described below If the problem persists call Roche Diagnostics Technical Service Center at 1 800 428 4674 24 hours a day 7 days a week Error Test Strip Solution A
19. 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 pe oHhance and interpretation s W CoaguChek XS Operator Certification Che Ni r S Section of l8cated this Policies amp Procedures ual ica in the FORMS Section of this icies amp Procedures Manual To order additional les of training materials or to make comments or suggestions about the training materials contact Roche Diagnostics Technical Service Center at 1 800 428 4674 or you may download them at www poc roche com Supplies Have at least one complete set of CoaguChek XS System supplies
20. 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 2 7 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
21. log for daily on board controls e Dosplit samples twice year com o Testing director determines numb iM o Use normal andfabn pati Massachusetts ae Submit tralipi tto CLP Perform 20 patient correlation study before testing patients and submit to CLP SNF granted a Special Project Waiver PT INR tests performed only by RN s Keep log for daily on board controls send to CLP quarterly Do 5 split samples quarterly send to CLP quarterly New Jersey Requirements e Perform correlation study before testing patients e Perform split samples twice year 10 4 APPENDIX B JOINT COMMISSION ANTICOAGULATION THERAPY NATIONAL PATIENT SAFETY GOALS 2008 Goals Requirement 3E Reduce the likelihood of patient harm associated with the use of anticoagulation therapy Rationale for Requirement 3E Anticoagulation is a high risk treatment which commonly leads to adverse drug events due to the complexity of dosing these medications monitoring their effects and ensuring patient compliance with outpatient therapy The use of standardized practices that include patient involvement can reduce the risk of adverse drug events associated with the use of heparin unfractionated low molecular weight heparin LMWH warfarin and other anticoagulants A 1 As of April 1 2008 the organization s leadership has assigned responsibility for oversight and coordination of the development testing and implementation of NPSG Requirement 3E A 2 As of
22. more information about error messages 6 Leave the correct code chip in the meter to protect the electrical contacts in the meter from becoming dirty Procedure for Performing Patient Tests With each new box of CoaguChek XS PT Test strips read the manufacturer s instructions included on the package insert to check for changes in procedures Retain the current package insert for reference Testing Patient Samples Collect and run patient samples according to the directions below first checking the product insert if a new box of test strips is opened to be sure no changes have occurred since the previous box 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 Indicate how Operators will be notified of any changes to the testing procedure 1 In order to create an audit trail to link the patient test with the piale CoaguChek XS meter complete the CoaguChek XS TestingiLo com for each patient tested Vul 2 Prepare the lancet device or ipumc f C g to the manufacturer s instructions 4 3 Place mej r on aiflat sufiace freevef Vibrations or hold it in your hand so the meter is roughly hrizontal Do n ove the meter during testing 4 Take a te ipso the container Close the container tightly Holding the test strip so the lettering CoaguChek XS PT is facing upward sli
23. needed Turns meter off before inserting or removing code chip Removes old code chip if one is installed Inserts new code chip until it snaps into place Performs Test Procedure Washes hands and dons disposable protective gloves Prepares lancet device or plastic syringe according to written pr dilres Removes test strip from container and replaces cap tightl co LJ Inserts test strip properly Obtains blood sample correctly Al Applies blood t trip c rre aid con n Reads and u derstands on results Reads and regords r Operly Properly discards used test strip and blood drawing supplies 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 results System Checks Documents remedial actions associated with QC and error messages States minimum cleaning frequency Demonstrates exterior cleaning procedure as stated in the User Manual Properly cleans test strip guide Demonstrates removal and replacement of batteries Reviewer Name and Title Date 9 5 COAGUCHEK XS METHOD COMPARISON LOG OPTIONAL Referral lab name Instrument used Type of Thromboplastin Reagent Lot
24. of blood then immediately place one drop of blood at least OW on the target area of a test strip which has been inserted into the Lp vito that ample drop is applied within fifteen seconds of the collecti d both the o needle and the er in e in thd s nu Apply sterile gauze Es j keeping the arm extended Keep press e site i Ensure that bleeding has stopped and apply a bandage ov site In A ur the patient to wear the bandage for at least 15 minut Specimen Handling Apply sample to the test strip within 15 seconds of collection Specimen Accessioning Log patient specimens to be tested on the CoaguChek XS Testing Log behind FORMS Section or if another method is in use indicate below what record is kept to record that patient specimens were collected and tested Specimen Rejection Criteria Do not accept glass capillary collection tubes or tubes containing heparin or other anticoagulants for testing on the CoaguChek XS meter Do not accept plasma or serum specimens for testing on the CoaguChek XS meter Do not accept samples less than 10uL Do not accept venous samples collected in a syringe containing anticoagulant Do not test samples that have sat for more than 15 seconds after finger puncture Do not accept samples collected in glass tubes or glass syringes Use only plastic Do not accept samples collected from the arm receiving the infusion line from patients who are on intravenous infusion therapy Do not
25. site making one smooth circular pass with an alcohol pad Allow the skin to dry to prevent the patient from having a burning sensation when the needle is inserted Do not touch the vein site after cleaning it 5 Perform the venipuncture Note Venipuncture should be performed after the meter begins to display the flashing test strip and blood drop symbols and the 120 second dosing countdown Collecting blood and or dosing the meter prior to the appropriate time will result in error messages a b Gently grasp the patient s arm near the venipuncture site using the thumb to draw the skin tight With the needle bevel facing up line up the needle with the vein Penetrate the skin and enter the vein at an angle of approximately 15 30 degrees Holding the barrel of the syringe steady and immobile with one hand begin slowly pulling back on the syringe plunger with the other hand As the blood begins to flow into the syringe release the tourniquet and open the patient s fist Collect approximately 1 to 2 cc s of blood you need 10 ul of blood for testing on the CoaguChek XS meter plus 4 drops of discard sample If a blood sample cannot be obtained change the position of the needle If the needle has penetrated too far into the vein pull it back a bit If it has not penetrated far enough move it further into the vein but do not probe with the needle Gently remove the needle from the venipuncture site Discard the first four drops
26. strips needles syriages Placed used needles lancets and other contaminated sharp objects into a sharps container that is spill proof tamperproof and puncture proof Do NOT recap bend break or remove needles from a syringe before discarding them In Case of Accident Notify the anticoagulation management program director or your immediate supervisor as soon as possible after an accident If an accident involves exposure to potentially infectious materials e g a splash or spray of blood onto non intact skin or mucous membrane or a needle stick follow OSHA s bloodborne pathogens standard requirements Procedure for Reporting Device Related Adverse Events When information reasonably suggests that a laboratory product has or may have caused or contributed to a patient death or serious patient injury the FDA requires you to report the event If the event is death make the report to both the FDA and the device manufacturer If the event is serious patient injury the report may be made to the manufacturer only Submit FDA Form 3500A http www fda gov opacom morechoices fdaforms cdrh html no later than 10 working days from the time personnel become aware of the event 4 2 SECTION 5 PREANALYTIC POLICIES AND PROCEDURES Policies for the Preanalytic Phase of Testing Our anticoagulation management program abides by good laboratory practices that include actions such as using two unique patient identifiers reco
27. test strip was already Remove the test strip Then inserted when the meter was repeat the test with a new turned on If you did not CoaguChek XS PT test strip remove the test strip after the last test you will see this error This error could also occur if the meter timed out after you inserted the test strip The test strip is unusable The test strip is not a CoaguChek XS PT test stri iaa 2 30 05 error Se 11 F3 Error Meter Temperature The meter is too cold or too warm to measure correctly error TM NE 4 Th att level is too low pata error Solution Turn the meter off and allow it to stand for about 30 minutes at room temperature between 65 F and 90 F Solution Replace the batteries See the Batteries section of this manual 41 Error Test Strip Guide Cover Solution Error Test Strip Expired Solution The test strip guide cover is Close the test strip guide The test strip has expired Check the meter s date not properly closed cover setting If it is not correct set the correct date For more Fir ipm i an ni r idu i e300 P information see the Meter Pa y error dl s P d Setup section of this manual De zal 1 If the date is correct turn the P d a meter off and remove the 1M code chip and the test strip Then use the code chip and a st strip from a new box of cO t strips e
28. 7 POSTANALYTIC POLICIES AND PROCEDURES Policies for Interpreting Reporting and Recording Test Results sssesesssssseeesss 7 1 Procedures For Normal Reference Ranges ccececeeececeeeeeeeeeeeeeeeee eee enne e eene nenne nnn nennen 7 1 Reportable Ranges Operating Ranges ccccceee eee ee ee eee eee ee ee eens eens eaeeeeeaeeeeeeeees 7 1 Interpreting Results eterne sakanen headed akncten debe E haceek hae bed gad n ERE NEA babes 7 2 Recognizing Unusual or Clinically Inconsistent Results 7 2 Critical Alert Action Value Procedures sssssssessee essem 7 2 Recording and Reporting Results E 7 3 Correcting Erroneous Test Results and Issuing Corr my 7 3 Ensuring the Security of Patiei V esul 7 4 Procedures for Usi 7 4 Communications mpl 7 4 Incident Managetent 8 ea Wh 08 eeeeesssssssenmI R R RRRe RH eme 7 4 Procedure for a Pagi SMUG oo eee eee IH emere 7 5 Replacing the Batteries dise ee rtv ern eere rndetdua intend aa d dirae merce bd Ru Dg 7 5 SECTION 8 QUALITY ASSESSMENT QA PONG CS oer mii rr aae ia Parra u b ETENE TENERNE FAAEE E IERA KM UK FURIA du ekRdr M NER E ds 8 1 QA Procedutes iiio rette ree dalla ga ea bea Yea RR eere dn b ag Ex eR M EErEE 8 1 Split Sample PrOCGQUre rnit kaataneet tnter emen iEn der Eie e unie fele Fete atus nie 8 1 Sources of Error in Split Sample Studies sssssssssssss
29. 8 334 2235 x245 7 802 652 4145 IL 217 782 7 6 WA 206 418 5418 IN 317 233 7302 N 05 841 4524 WI 608 243 2023 WV WY Source http www cms hhs gov CLIA downloads CLIA SA pdf CLIA regulations divide testing sites into 3 categories depending on the complexity of the tests performed 1 Waived 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 2 Pay CLIA fees of 150 every two years 3 Follow the manufacturer s instructions for performing the test 10 2 If your facility needs to apply for a CLIA certificate follow these 3 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 register a new laboratory for a certificate of waiver Form CMS 116 is also available online at the CLIA website http www cms hhs gov cmsforms downloads cms116 pdf Ask the CMS representative for the address or fax number and the contact person who will receive your completed CLIA application STEP 2 Complete Form CMS 116 and any additional state forms required In Section II of Form CMS 116 check Certificate of Waiver STEP 3 Mail or fax Form CMS 116 and
30. Chek XS Meter Elements Show participants each of the following elements on a CoaguChek XS meter Side JjDescipion O Code chip slot Insert code chip here Front sd Description O Display Shows results information symbols and results recalled from memory OMOFF baton CT T E or ft Test sip oude a X Mri WF Test strip guide affe V Vino HMM Umi e RR Battery cover and tab Covers the battery compartment Press tab to slide cover off Roche Diagnostics Technical Call 1 800 428 4674 for technical service 24 hours a day 7 Service Center days a week Cleaning Supplies CoaguChek XS PT Test Strip Show each of the following components 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 code chip Insert 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 6 5 Explain the proper conditions for operating the meter Attemperatures between 65 F and 90 F 18 C and 32 C in areas without condensation In artificial light or indirect sunlight Avoid bright sunlight Ona flat level surface free of vibrations At altitudes no higher than 14 000 feet
31. CoaguChek XS System User Manugl4W valor QOO Table of Contents About this Manual Symbols and Abbreviations Getlig SUA sesion P A nents User ERU Test Strip Package Inserts The CoaguChek XS M Anticoagulation Medficati8h ee 3 Blood clotting Ti e Meter Setup iicet cte ba 9 Setting the Date amd Tif 9 MORE 12 Inserting a New Code Chip 12 Integrated Quality Controls 14 Testing a Blood Sample s 15 Tips for a Good Fingerstick 15 Important Notes about Blood Testing sss 16 PAWS A E T matu tita titer sep E 16 Mg ce Al acne E A OE E E 16 Infectiori Controleren 17 Preparing Tor a Teslecsnenenocineneiminnenen tope 18 Performing a Testoni EAA 20 Qut of Range VANES encsi 24 Optional Testing Methods 25 Using Capillary TUDES rtr 25 Using Venous Blood 28 MEMON Me E 30 Storing Test Results in Memory 30 Reviewing Stored Test Results Erasing Stored Test Results s Cleaning the Meter 34 Cleaning the EXEEFIOE csi iet detenta eed 34 Cleaning the Test Strip Guide 35 Advanced Features trea 37 Setting Advanced Features ns 38 The Meter s Display ee 39 Error Messages teatro a Error Messages You May See After You Apply Bl
32. CoaguChek XS Patient Test Fill out for each patient tested 9 7 Log Monthly QA Checklist Monthly 1M Split Sample Log Use when a periodic I te 9 9 val lations 9 1 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 amp Procedures Manual Sample Handling Review the requirements for specimen collection sample handling and processing Instrument Components Identify and locate the following instrument components y Display V Test strip guide V On Off button y Battery cover and tab y Test strip guide cover V Code chip slot and code chip s Identify the following icons and symbols y Apply Blood Sample V Error messages V Automatic QC successful Y Room or meter tempgrature outside acceptable NI y Results above or below instrument range range 1 Battery Status i om 4 Controls Review and assist as needed y Importance of qualifPtontrol Interpretation of onboard controls System Operation Overview Review and assis ed y Loading correct code chip X Follow screen prompts to process samples y Handling test strips and preparing to test y Interpret results Daily Procedures Review and assist as needed y Cleaning procedures y Telephone troubleshooting Roche Technical V Log Sheets see FORMS section Service 800 428 4674 General
33. July 1 2008 an implementation work plan is in place that identifies adequate resources assigned accountabilities and a time line for full implementation of NPSG Requirement 3E by January 1 2009 lt M A 3 As of October 1 2008 pilot testing in at least one clinical unit isfjunder way hegyeiation A 4 As of January 1 2009 the process is fully implemedt ed 4 Implementation Expectations for 3 amp that wi i lary 1 2009 are A 1 The organization ingplemefts ed lant management program to individualize the care provide ea r tigoagulant therapy A 2 To reduce c mpoungin products and pre f i ions when these products are available Related 2008 National Patient Safety Goals Ambulatory Care M C 3 When pharmacy services are provided by the organization warfarin is dispensed for each patient in accordance with established monitoring procedures M C 4 The organization uses approved protocols for the initiation and maintenance of anticoagulation therapy appropriate to the medication used to the condition being treated and to the potential for drug interactions M A 5 For patients being started on warfarin a baseline International Normalized Ratio INR is available and for all patients receiving warfarin therapy a current INR is available and is used to monitor and adjust therapy M C 6 When dietary services are provided by the organization the service is notified of all patients receiving warfarin and re
34. NOT add more blood to the first test strip The typical time e A that the results are given to the provider is Procedure Notes Operating the meter outside the temperature range of 18 to 32 C 65 to 90 F will cause an error message to be displayed on the meter Make sure the correct test code chip is in the meter Don t remove or insert a test code chip while performing a test Follow the information on correct handling of test strips in the package insert Keep the vial of test strips securely capped when not in use and don t handle test strips with wet hands or gloves Improper handling or storage of test strips may cause an error message to be displayed on the meter Begin collecting sample when the meter displays the flashing test strip and blood drop symbols Use the test strip within 10 minutes of removing from its container Apply a capillary sample to the test strip within 15 seconds of the fingerstick 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 and Argatroban The blood sample must be at least 10 ul Low sample volume will cause an error message to appear on the meter The CoaguChek XS System uses only fresh capillary or non anticoagulated venous whole blood Plasma or serum cannot be used 6 6 Use only plastic syringes without anticoagulants or additives Do not use glass tu
35. Off Turn the meter off Press the M button XM to change the year Press the SET button Press the M button i to i3 F00 change the month Press the 1e 3 0B SET button ETN 12 3 00 Press the M button i to ab change the day Press the SET button Code Chip 2 Match Codes Make sure that the three number code on the new test Each box of test strips comes with its own code chip The code strip container matches the chip provides the meter with information such as the lot number three number code on the and expiration date of the test strips new code chip Before each test make sure the correct code chip is in the meter Each time you open a new box of test strips replace the old code chip with the new one Protect the code chip from moisture and also from equipment that produces magnetic fields such as a microwave oven ide the new code chip into the code chip slot until it snaps into place Inserting a New Code Chip Have the correct code chip ready ip and Testing a Blood Sample Integrated Quality Controls Tips for a Good Fingerstick The CoaguChek XS System has quality control functions integrated For fingerstick blood testing increasing the blood flow in the finger into the meter and test strips so you never have to run quality will help you get a good drop of blood Before you prick the finger control tests with liquid quality controls The meter automat
36. ality control test fails the meter will s give a m result 9 The most recent patient result appears first when r eom 10 The CoaguChek XS meter stores up 4o Zt date 11 What is used t i XS meter o oo What could cause What does it mean when the display i shows What could cause to appear on the display How long can strips be stored at room temperature 9 3 Operator Certification Test Answer Key Te T 2 T 3s T 4 T 5 T 6 F International Normalized Ratio 7 T 8 F Ifthe built in quality control does not pass a flashing QC will appear on the display 9 T 10 T 11 Use a 10 bleach solution or 70 isopropyl alcohol solution 12 Code chip is damaged missing or not snapped firmly into place 13 Meter was stored above or below the proper operating temperature Turn meter off and let sit at room temperature for 30 minutes 14 The test strip failed the internal quality control check The test strip is unusable Turn the meter off and remove the test strip Repeat test using a new test strip and blood taken from a new fingerstick from the opposite hand 15 Strips are stable for 18 months or the expiration date whichever comes first when stored at room temperature COAGUCHEK XS OPERATOR EVALUATION CHECKLIST OPTIONAL CoaguChek Operator Evaluation Date Observe operator during testing and mark the following items Yes or No Reviews Procedure States when coding is
37. an 0 8 or gt greater than 8 0 If the meter indicates an out of range value refer to the test strip package insert and repeat the test In rare cases Error Message 7 can occur in patients with long coagulation times gt 8 INR If this error message appears again when the test is repeated the result must be checked using another method 24 Optional Testing Methods Using Capillary Tubes You may use capillary tubes to collect the blood from a fingerstick and to dose the test strip Use only CoaguChek Capillary Tubes Bulbs Cat No 11621173001 Do not use glass capillary tubes or capillary tubes that contain anticoagulants The following steps r ebnal to the fingerstick blood sample instructions in the Preparing for a Test and Performing a Test Kections ofgthis CO Firmly insert the end of the capillary tube into the capillary bulb Completely insert the tube into the bulb to break the bulb diaphragm Do not push the capillary tube in so far that it extends beyond the top of the bulb 25 26 2 Fill the Capillary Tube When the flashing test strip 4 Record Result Record the result according to appears on the meter s your facility s guidelines display stick the fingertip Then touch the capillary tube to the blood drop Keep the tube level and allow it to fill by capillary action Fill the tube only halfway Avoid getting air bubbles into the sample Do not touc
38. any additional required forms to your state CMS office Note that Medicare Medicaid will NOT pay for tests performed before the effective date of the CLIA certificate which is the day CMS enters the application in their database not the day you complete the application So do not begin testing Medicare or Medicaid patients until receiving notification from your State agency or CMS with the CLIA number and its effective date Accredited Facilities CAP Joint Commission COLA Accrediting Agencies Some testing facilities especially those associated with hospitals or that are part of integrated delivery networks voluntarily choose to be accredited by an agency su s the Joint Commission JC or the College of American Pathologists CAP ny physician office based testing programs opt for accreditation by COLA To be a cep genei t can inspect testing facilities in lieu of CLIA inspectors accreditati e requirements that are overall as stringent as the fed i Checklists for their ts t uirements and these Checklists are C ng agencies provide updated frequen tains a brief overview of quality requirements for three common a for non waived tests as of January 1 2008 Consult Checklists provid accreditation agency for more specific and updated information Waived Tests CLIA COLA JC CAP Personnel educational None None None requirements Personnel None Follow Documented training Documented training Tra
39. apy is important under anticoagulation increases the risk of stroke while over anticoagulation increases the risk of bleeding episodes The appropriate therapeutic range for individuals undergoing conventional warfarin therapy is typically from 2 0 to 3 0 INR Individuals who receive more intense therapy such as mechanical heart valve replacement patients often have a target range from 2 5 to 3 5 INR The CoaguChek XS monitor offers a convenient quick way to confirm that a patient is within the appropriate target range right at the point of care The monitor uses a lot specific code chip and takes a single drop of capillary or venous whole blood It displays the result in approximately one minute and can be configured to display results in INR seconds or Quick The CoaguChek XS PT test strips are manufactured with a human recombinant tissue factor and haye an International Sensitivity Index ISI of 1 0 z The purpose of this study was to evaluate the performa t 6 LCOS System specifi cally in terms of accuracy and pgecisi CO dard itional laboratory methods METHODS Prothrombin Time test results were obtained from CoaguChek XS monitors from three external sites using both capillary and venous whole blood The PT results are presented in INR International Normalized Ratio units The INR was created to allow for differences in the sensitivity of different thromboplastins The sensitivity of a thromboplastin is defined by its Interna
40. bes or syringes Never add more blood to test strip after test has begun or perform another test using the same fingerstick When a patient is on intravenous infusion therapy do not collect sample from arm receiving the infusion line No significant effect on test results was seen with Bilirubin up to 30 mg dL Lipemic samples containing up to 500 mg dL of triglycerides Hemolysis up to 1000 mg dL Hematocrit ranges between 25 55 Heparin concentrations up to 0 8 U mL Clopidogrel up to 20 mg dL Fondaparinux up to 5 mg L Low molecular weight heparins LMWH up to 2 IU anti factor Xa activity mL The presence of anti phospholipid antibodies APAs such as Lupus antibodies LA can potentially lead to prolonged clotting times i e elevated INR values A comparison to an APA insensitive laboratory method is recommended if the presence of APAs is known or suspected In rare cases patients with long clotting times gt 8 INR may receive an ERROR 7 message on the meter display If this error message appears again when the test is repeated check the result using another method lt M co u p waive 6 7 SECTION 7 POSTANALYTIC POLICIES AND PROCEDURES Policies for Interpreting Reporting and Recording Test Results The documentation system used in this facility ensures that CoaguChek XS operators examine results before reporting to the ordering physician Results from one patient are not mixed up with another la
41. blished when initially setting up the CoaguChek XS meter Result Units LJ INR LJ sec L a p Date format Time format bac om Options Beeper Tone Eo Therapeutic Rangf LoWer Set Ran Upper Range Procedures for Setting Time and Date 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 Once the date and time are set the meter automatically moves to the main menu where you can start a test or enter more settings The next time you turn the meter on the date and time will remain and you will automatically go to the main menu Storing the Meter and Test Strips The CoaguChek XS System contains built in self checks to ensure that the meter and test strips were stored properly the CoaguChek XS System will not allow patient test results to display when temperature ranges have been exceeded If the storage of the meter exceeded the proper temperature limits the thermometer symbol below will appear on the meter 6 1 In this case turn the meter off and let sit at room temperature for 30 minutes Check room temperature and adjust if necessary Contact Roche Diagnostics technical service 1 800 428 4674 for guidance if needed To minimize wast
42. boratory test reports reach the ordering physician within the time frames specified and all results are retrievable In order to consistently deliver accurate results reflecting patients true status the following procedures for mitigating possible sources of error have been instituted Procedures for Normal Reference Ranges The health provider determines the optimum INR level for each patient depending on the reason for anticoagulation treatment and how the patient responds to treatment as measured by the prothrombin time There are two recommended therapeutic ranges a less intense range of 2 0 3 0 INR anda more intense range of 2 5 3 5 INR for patients with mechanical jd ves Ref Hirsh J MD FCCP Chairman et al Oral Anticoagulants Mechanismibf Acti ini tiveness and n determines the appropriate therapeutic range Ividual patients Notes regarding normal rapgesin thi avon 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 lt 0 8 INR or gt 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 Repeat the test with a new strip and a new fingerstick In rare cases Error Message 7 can occur in patients with long coagulation times gt 8 INR If this error message appears again when the test
43. ce 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 ine CoaguChek XS meters Y co Individuals Involved in the SAMMProgra Indicate those responsille for Man nt n iding education to patients and their families safety ag regulatory G amp mplian Title Role s on SAM Team 1 2 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 Tabs 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 Report generated and conveyed to strip Na Patient test logged yeder checked by testing personnel Patient specimen is analyzed only after meter function checks are OK 1 3 SECTION 2 PERSONNEL TRAINING POLICIES AND PROCEDURES Personnel Policies Persons who perform tests on
44. ceptable 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 and Operator Certification Test Evaluate whether the anticoagulation management program is achieving stated goals CoaguChek XS System Policies amp Procedures Approval Form This Policies amp Procedures Manual for our Systematic Anticoagulation Management Program was read by Date Name Title nwa vedo Prepared Customized By Name Title Approved By SAM program director Date Adopted Date Discontinued Revisions Revision Date Revised By Approved By Read By 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 med
45. ch solution 1 part bleach and 9 parts water 70 isopropyl alcohol solution lint free tissues cotton swabs Caution Do not spray any cleaning solution on the meter Never use a spray of any type the metef turned the metens exte 2 Clean the Test Strip Guide Clean the easily accessible gt areas with a cotton swab Cleaning the Exterior 1 Clean the Exterior Caution Do not insert any objects into the test strip guide Doing so could damage the electrical contacts behind the test strip guide 2 Dry the Exterior With a lint free tissue dry the meter 35 36 3 Allow to Dry bw 4 Close the Cover With the cover off allow the test strip guide to dry for about 10 minutes Close the cover and make sure it snaps into Advanced Features The CoaguChek XS Meter includes advanced features that you can set up as necessary They are Changing the unit of measurement Turning off the beep With the beep turned on the meter beeps when it detects a test strip when it is ready for you to apply a sample when it detects a sample when the result is displayed and when an error occurs 3 short beeps Setting a therapeutic range for INR only TM Mhe followiag talfgi hows re and the default setting D d afi Feature Setting Options Unit Q Sec INR Beep On Off Therapeutic range On for INR only Off Set range Lower range 1 5 3 5
46. cine free of charge Employees who choose not to receive the Hepatitis B vaccination must sign a declination form Hepatitis B vaccination records are kept CoaguChek XS operators must follow the safety procedures below to prevent potentially dangerous accidents Safety Procedures 1M com Safety Precautions for the Testing Area I Do not eat drinks smok ap S rt Contact lenses where specimen collection sting is perfo h Do not st re foo refri tors where test reagents or specimens are kept Clean co e testing is performed daily and whenever visibly soiled Clean spills immediately Effective disinfectants include a 10 bleach solution and EPA approved hospital level disinfectants such as quaternary ammonium compounds Wear rubber utility gloves when cleaning f the exterior of the CoaguChek XS meter is visibly soiled with blood clean with either a 10 household bleach solution or 70 isopropyl alcohol solution Safety Precautions for Working with Potentially Infectious Material Consider all patient specimens to be potentially infectious Wear gloves to prevent skin and mucous membrane contamination when collecting specimens and handling blood samples for testing Blood specimens are potentially capable of transmitting bloodborne pathogens such as the human immunodeficiency virus hepatitis C virus or hepatitis B virus in three ways 1 A splash or spray to non intact skin 2 A splash or spray to a mucous membrane 3
47. d The documentation system for PT INR test results should contain the date s the specimen was collected tested and reported a well as the initials of the testing analyst and the name and address of the laboratory where the specimen was tested Indicate where the following are located CoaguChek XS Testing Log Patient test requisitions Final test results Keep these items for a minimum of 2 years Describe the process for reporting PT INR results to the ordering ph sithhn Include how abnormal results are treated differently than normal results if applig ble Mm e NASAL Ve Correcting Erroneous Test Results and Issuing Corrected Reports Immediately after recognizing an erroneous result has been reported 1 Contact the individual who received the original report and notify him her of the error If the patient is available for testing tell the caregiver whether or not a corrected result will be forthcoming If the patient is not available ask the caregiver if the patient should be re drawn and re tested 2 Document on the original report that the result was in error Have the ordering physician re sign the report indicating awareness of the error 3 When possible retest to obtain the correct result 4 Report the corrected result noting on the report the original result and that this is a corrected result 5 Document the incident on the Monthly QA Checklist Include all the actions associated with the erroneous result inc
48. d the meter begins a countdown You have 120 seconds to apply blood to the test strip 4 Collect the Blood Twist the protective cap off the CoaguChek lancet Massage the finger until you see increased color in the fingertip Keeping the hand down press the tip of the lancet firmly against the side of the fingertip Press the blue trigger button Gently squeeze from the base of the finger to develop a hanging drop of blood 21 5 Identify the Target Area Find the target area on the test strip You can dose the target area by bringing the patient s finger to CP the top of the test strip or by Lu M ow es bringing the meter to the eo t patient s finger so that the side of the test strip touches the blood drop Within 15 seconds of sticking the fingertip apply the blood 6 Apply the Blood Do not add more blood to the test strip Do not touch the test strip W The result appears in about 1 minute 22 7 Record Result Record the result according to your facility s guidelines Place the used test strip and lancet in an approved container Turn the meter off If the meter is dirty wipe it clean with a CoaguWipe Bleach Towel or other recommended cleaner 23 Out of Range Values The CoaguChek XS PT test strips provide test results if the INR value is between 0 8 and 8 0 If the result falls outside of this range the meter displays lt less th
49. de the test strip into the test strip guide in the direction indicated by the arrows Slide the test strip in as far as it will go to turn the meter on A beep tone indicates that the meter has detected the test strip provided the beeper is turned on in the settings 5 Check the battery level If there are no bars left in the battery symbol you cannot perform any more tests Change the battery 6 Check that the date and time are correct Correct any wrong entries as described on page 6 2 7 Confirm that the code number displayed on the meter matches the number on the test strip container If the numbers are different make sure you are using the code chip that came with the test strips you are using If the numbers match press the M button to continue 8 When the blood drop symbol flashes to indicate that the meter is ready to perform the test and is waiting for blood to be applied a 120 second count down begins 9 Collect the fingerstick or venous blood sample as outlined below Fingerstick sample DO NOT wipe away the first drop of blood Apply the first drop of blood to the top or side of the target area of the test strip within 15 seconds of puncture Hold the blood drop to the test strip until you hear a beep provided the beeper is set to ON Using the Capillary Tube Touch the CoaguChek Capillary tube to the blood drop Keep tube level and allow it to fill halfway by capillary action Put finger 6 5 10 over
50. eW a W Begi e ca oya cing yourself and your assistant Ask operators to introd Review rcm ean 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 Mid ap 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 5 CoaguChek XS meter A portable coagulation meter for PT INR testing 4 AAA batteries AAA 4 AAA batteries The meter s power source CoaguChek Lancets with Devices used to obtain fingerstick blood sample for instructions testing 10 bleach solution or 70 isopropyl alcohol solution lint free tissues and or cotton swabs Manual operators Started Guide operators amp Procedures Manual and use of the CoaguChek XS System Coagu
51. ed in the meter s memory You cannot however erase individual test results To erase all stored results 1 Go to Erase mode With the meter turned off press and hold down the M button GW While you are holding down the M button press the ON OFF button D and then hold down both buttons for at least 5 seconds UA V 3b The meter displays mem N zt mem flashing and clr The i number of results in memory is shown in the top right am corner of the display r 2 Confirm Press the M button Qj to confirm that you want to erase the entire memory Note To exit Erase mode without erasing the results press the ON OFF button instead The hourglass symbol flashes aan while the test results are being erased Then the e e counter is set to 0 and 3 dashes appear 33 Cleaning the Meter It is important to keep the meter clean Clean the meter whenever Cleaning the Test Strip Guide it looks dirty or if you prefer a regular schedule clean the meter h ti f test strips Relay dime you Operi new Dax altest stipe 1 Open 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 Use only the following products to clean the meter CoaguWipe Bleach Towels or other pre packaged bleach towelettes 10 blea
52. ed tests operate the CoaguChek XS System at a room temperature between 18 32 C or 65 90 F and 10 85 humidity Store CoaguChek XS PT Test strips at room temperature OR in the refrigerator 2 to 30 C or 36 to 86 F Store test strips in their container with the cap closed Remove one strip at a time from the test strip container and keep the container closed between tests Do not remove a test strip with wet hands or gloves this may damage the test strip 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 Always use the code chip from the current box of test strips Mot mix code chips and strips from different boxes I Code Chip Storage and Sf bili Protect code Ld oistufe a ioment that produces magnetic fields 6 2 Ordering Test Supplies CoaguChek XS PT Test strips are purchased from Company Name Telephone Instrument Maintenance Cleaning the Meter Clean the meter whenever it becomes dirty as directed in the CoaguChek XS User Manual Turn off the meter and wearing gloves wipe with a soft lint free cloth or cotton swab moistened with 10 bleach solution or 70 isopropyl alcohol solution Never spray a cleaning solution on the meter A spray of any type may enter the meter and damage it Cleaning the Test Str
53. eeeeeeeseeeeeeenaneeseetenees ii SECTION 1 SYSTEMATIC ANTICOAGULATION MANAGEMENT SAM PROGRAM OVERVIEW Purpose of the SAM Programs reo Ernte xen pte eck sehen DEA e FERRE RE teddies Eaa 1 1 Policies and Procedures for the SAM Program ssssssssssssseem mee 1 3 SECTION 2 PERSONNEL TRAINING POLICIES AND PROCEDURES Personnel PoliCi S 0 ccc ccc c cece ene eee eee nee ene e me e nmm me nemen nemen se se es rese rn nnn nnne 2 1 Anti Coagulation Program Director Responsibilities csse 2 1 Operator QtuialifiCatiorns lei eroe tues E faciet rer resDadnbeutbuxveirdsdDe nita diede Denarius pidae 2 2 CoaguChek XS Operator ResponsibilitieS cece cece eee ee cece eee eee e eee eeeeeeene ene enea 2 2 Procedures for CoaguChek XS Operator Training and Evaluation cccececeee cesses eeeeees 2 3 Operator Training Certification 02 cc cece cece eee e eee cnet eee e Imm meme Suggested In service CurriculUM ccc ccc ee eee e eee eee e eee e ee eee ease eee eae e meme eene Operator Competency Evaluation Optional sss p M SECTION 3 METHOD COMPARISON OPTIONAL Suggested Procedure for Method Comparison Sources of Error in Method Compariso udi AREA SECTION 4 SAFE Safety Polici6s M aii ierit enin be rh er pe Prize rus 4 1 Safety Procedures II sasecniecytenssaptenssagientecyatnemcbeunbevsuasnetnden EHE ERE R
54. en made have all affected personnel been made aware of them Observe one or two CoaguChek XS operators Do operators follow the manufacturer s instructions for test performance and _ troubleshooting Were patients properly identified using two distinct identifiers Were test strips stored properly and within the Use by date If personnel competency problems were identified or observed was corrective action instituted to assist employees to improve perfor RRE Check CoaguChek XS Testing Log Were all patient tests logged completely and corgeetl Oe on identifier QC acceptability reagent lot numbers efte f lems th Did any complaintsgor c unicati cerning testing or c reportin nt speci If s ere they resdlved by the program director and documented on this Monthly QA hecklis Did any ps occur this month with patient identification If an incorrect patient test result was reported did the operator notify the person who ordered the test of the correction and submit a corrected report Are both original and corrected reports being kept for 2 years Pull five patient charts and check the following Written test requests are available for PT INR tests ordered Manually entered results were transferred accurately located in the correct patient chatt and in the proper area of the patient chart Caregiver saw test report and acted on it when necessary Attach any pertinent reports to this checklist co
55. ents B Joint Commission These goals are mandatory for facilities accredited by 10 5 Anticoagulation Therapy Joint Commission National Patient Safety Goals 10 1 APPENDIX A REGULATIONS GOVERNING TESTING All laboratory tests that are performed on humans for the purpose of diagnosis treatment or monitoring fall under the federal Clinical Laboratory Improvement Amendments of 1988 CLIA 88 or simply CLIA The CLIA program is administered by the Centers for Medicare and Medicaid Services CMS Each state except for those that are exempt from federal standards Washington state and certain testing facilities in New York has at least one office where CMS surveyors are located A listing of state CLIA contacts appears below State CMS Offices AL 334 206 5120 KY 502 564 2800 NY POL 518 485 5352 AK 907 334 2491 LA 225 342 9324 NY Other 518 485 5378 AR 501 661 2201 MA 617 983 6739 OH 614 644 1845 AZ 602 364 0741 MD 410 402 8025 OK 405 271 6576 CA 213 620 6160 ME 207 287 9339 OR 503 229 5853 CO 303 692 3291 MI 517 241 0821 PA 610 280 3464 CT 860 509 7400 MN 651 215 8704 RI 401 222 4526 DC 202 442 4706 MO 573 751 6318 SC 803 545 4291 DE 302 653 2870 MS 601 576 7300 SD 605 773 3694 FL 850 487 3109 MT 406 444 1451 TN O45 741 7023 GA 404 657 5447 NC 919 733 1610 TX d 512 834 6650 HI 808 692 7420 cower IA 319 335 4500 804 367 2107 KS 785 296 3 775 687 4475 304 558 3530 x2103 307 777 6057 ND 701 328 2352 NE 471 436 p ID 20
56. 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 lancet device 1096 bleach solution 1 part bleach to 9 parts water or 7096 isopropyl alcohol solution 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 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 10 Section 1M 9 Q amp A conclusion j revel Approximate total ti ive e es 1 Introduction rvi
57. ge the electrical contacts behind the test strip guide Caution participants never to spray any cleaning solution on d CoaguChek XS meter as this may enter the meter and damage it Advise participants to decontaminate the rive X pi M shipping or disposal Explain i i A Y GU through referencing the User i Al may require the help of Roche Diagn stics T i rvice at 1 800 428 4674 ol 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 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 operators CoaguChek XS Operator Certification Checklist and Operator Certification Test State where these are located Q amp A Session Conclusion about 5 minutes Question atte
58. h the hole at the top of the bulb If blood gets into the bulb during sample collection discard the bulb and After testing discard the capillary tube along with the used test strip and lancet according to infection control guidelines 3 Dose the Test Strip the test strip Put your finger over the hole at the end of the capillary tube Hold the capillary tube directly over the target area of the test strip Squeeze the bulb to dispense one hanging drop of blood Do not touch the test strip move the meter or add more blood during testing 27 28 Using Venous Blood You may use the CoaguChek XS Meter to test venous blood Blood may be collected directly using a butterfly or a needle and syringe Do not clean the syringe tip with alcohol or water prior to dosing the test strip Use only a plastic syringe free of anticoagulant Do not use glass The syringe needle should be 23 gauge or larger A 21 gauge or larger needle is recommended 2 Dose the Test Strip Note Refer to the Preparing for a Test and Performing a Test sections of this manual for fingerstick blood testing instructions When the flashing test strip appears on the meter s display collect the ven blood sampl nipu t st 1 Collect the Venous Sample Record Result 4 Dispose of Blood Collection Items Discard the first 4 drops of blood Then immediately place 1 hanging drop of blood directly ont
59. 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 100 test results along with the time and date When reviewing memory the ostgecent result is displayed first If the memory is full when you perform a test the oldest result is automatically deleted The most rec nt n al ere a Review the following steps to rec t are stored in memory ss thaM T ns on if itis not already on and goes to ng a result in memory If there are no results in memory 3 dashes are displayed and a 0 appears in the top right corner 3 Use the M button to scroll through the meter s memory 4 Turn the meter OFF e 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 lt 0 8 INR or gt 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
60. he problem and how the problem was resolved d A Incident Manag An incident is an vent that could r sult i ious injury for patients or staff These incidents stem from syste non iafice with written policies and procedures When an incident occurs in this testi gram collect and verify the facts and review and discuss them with the anticoagulation management program director promptly Determine if the incident was medically significant by evaluating its impact on clinical diagnosis and treatment of patients The following are some incidents that might lead to the wrong diagnosis wrong treatment delay in treatment serious injury or death but are not limited to Misidentification of the patient Injury to the patient due to phlebotomy Misinterpretation of results due to improperly trained or unqualified personnel Accidents causing injury to operators Results not reported reported incorrectly placed on wrong chart or critical values not reported properly Address the problem immediately identifying who will be responsible for managing the incident Determine whether testing should be stopped Develop a corrective action plan and implement the corrections Verify an effective resolution before resuming patient testing Record these actions on the Monthly QA Checklist If the incident did affect patient test results the anticoagulation management program director will handle each incident on a case by case basis and dete
61. heir 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 05176565002 0808 CLIA warvedcom For more information please contact CLIAwaived Inc at 4332 Corte de la Fonda m San Diego CA 92130 Tel 858 481 5031 m Toll Free 888 882 7739 E mail info cliawaived com Visit us on the web at www cliawaived com Distributed by CLIAwaived Inc Policies amp Procedures Manual for the CoaguChek XS System Table of Contents Getting Started With the CoaguChek XS SyStemM ccccccceeceeeeeeeeeeeeeeeeeeeeeeeeeeseeeeneeeeeeesseneeeeees i Policies and Procedures Approval Forim cccccceceeeeceeeeeceeeeeeeeaeeeceeeeeeeaeeeee
62. hole in the capillary bulb Hold capillary tube directly over sample target area and expel sample within 15 seconds Venous Sample Expel the first four drops of blood from the syringe or syringe needle Then immediately place one drop of blood at least 10 ul directly onto the target area of the test strip being sure not to introduce air bubbles into the sample Apply the blood directly to the semicircular transparent sample application area of the test strip You will hear a beep tone when you have applied enough blood provided the beeper is turned on The blood drop symbol disappears and the test starts Note DO NOT add more sample DO NOT touch the test strip or move the meter until the result is displayed 11 12 The meter automatically performs a two level on board quality control test on the test strip before it displays the test result QC appears in the display Following a successful outcome of the quality control test a check mark appears after QC Wait for results this takes about one minute 13 The result is displayed in the unit of measure you chose when setting up the meter It is automatically saved to memory Read and record results on the CoaguChek XS Testing Log Remove the test strip from the measurement chamber Turn meter OFF Dispose of all biohazardous material in the biohazard or shar s qgntainer Note Use a new fingerstick from the opposite a J t amp eu must retest DO
63. ically try the following techniques until you see that the fingertip has runs its own quality control test as part of every blood test good color When the quality control test runs the letters QC flash on the Warm the hand by having meter s display When the quality control test completes a the patient hold it under his checkmark appears following the letters QC Then the meter or her armpit use a hand continues to run the blood test 1M warmer and or wash the hand with warm water O ave the patient hold his or C her arm down to the side s so that the hand is below the waist If the quality control test fails the meter displays the following error message See the Error Messages section in this manual for an explanation of this and other error messages and what to do when they occur CUA Massage the finger from its base If needed immediately after pricking gently squeeze the finger from the base to encourage blood to flow Important Notes About Blood Testing Always Operate the meter at temperatures between 65 F and 90 F 18 C and 32 C Refer to the test strip package insert for proper use and handling of test strips Keep the test strip guide and meter clean You may occasionally need to clean them See the Cleaning the Meter section in this manual for more information Never Store the meter in damp or humid conditions greater than 85 humidity Remove or
64. ications 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 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 usedqyin patient care treatment and services To better manage patients receiving warfarin therapylby i acm values to be sure that patients are taking th dose AINE etapy f t e e correct To have a rapid INR resultdn or Ou ria to determine optimum patient therapy To reduce th elingod of adverse events associated with the use of anticoagulation therapy To establish b Rs 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 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 1 1 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 performan
65. ining evaluation manufacturer s initially evaluation initially evaluation instructions annually thereafter after first 6 months and annually thereafter Quality Control QC Follow Follow Follow manufacturer s manufacturer s manufacturer s instructions instructions instructions QC Documentation None required Required Not required for on board controls due to automatic lockout Inspections audits None Every 2 years Every 2 years Split sampling None None Yes Method comparison No No No 10 3 State Regulations That Differ From the Federal CLIA Regulations As of January 1 2008 all of the states below are known to have regulations that exceed the Federal CLIA regulations for certain kinds of testing facilities If your facility is located in a state listed below contact that state for any forms needed to register your CLIA waived testing program in that state Also please note that states regulations can change and you are responsible for awareness and compliance to these changes if and when they take place States With Additional Testing Regulations e Maryland e Pennsylvania e Massachusetts e New Jersey Maryland Requirements e Perform 20 patient correlation over 5 days before testing patients e Keep logs of on board controls initial training P amp P Manual e Do split samples three times year o Use 5 patient samples study Pennsylvania Requirements e Perform 5 patient correlation before testing patients 1M e Keep
66. insert the code chip whilethe meter performing a test Use a code chip from a boy of test strips other thagsthe one in use Open a vial of test strips o st or gloves with wet hands Touch or remove the test strip during a test Wait more than 15 seconds after sticking the fingertip before applying the blood Add more blood after the test has begun Touch any buttons while a test is in progress Perform a test with a drop of blood from a previous fingerstick Infection Control Follow appropriate infection control guidelines Use gloves Use a separate lancet for each person Dispose of used lancets and test strips in a stable container with a lid according to infection control guidelines Follow all other A and safety procedures applicable ution There Pu infection Medical staff and j eter to perform tests on Ware that any object coming into blood is a potential source of Infection See al E for Clinical Laboratory Standards Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue Approved Guideline NCCLS document M29 A 1997 Dispose of used items according to the disposal policy of your facility 9 Preparing for a Test 3 Insert Code Chip Make sure the meter is turned V off With the code number facing up insert the code chip 1 Gather Items Gather the following items 4 into the c
67. iod is longer 04837991001 0806 CLIA walvedcom For more information please contact CLIAwaived Inc at 4332 Corte de la Fonda m San Diego CA 92130 Tel 858 481 5031 m Toll Free 888 882 7739 E mail info cliawaived com Visit us on the web at www cliawaived com Distributed by CLIAwaived Inc CoaguChek XS System _ Policies amp Proced pes Manual This Policies and Prod amp dures Manual repar d by Roche Diagnostics with the contribution of Sheila Dunn D A MT ASCP It cofifains s cies and procedures to help you provide the highest quality anticoagulation testing We hope this manual becomes a valuable tool for you and your staff Before using the CoaguChek XS System customize this Policies amp 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 Roche Diagnostics All Rights Reserved The author s and t
68. ip Guide When cleaning the exterior of the meter also check the test strip guide for signs of soiling with blood or any other material If present don disposable gloves and perform the following maintenance 1 Turn off meter and open the cover of the test strip guide by pressing upwards from the front e g using your thumbnail 2 Move the cover safely away from the meter With gloved hangs Wse a soft lint free cloth or swab moistened with a 10 bleach solution or 70 isopropyl alcohol solution 3 With gloved hands use a soft lint free cloth o w i n j 1096 bleach r solution or 70 isopropyl alcghol solution accessible white areas of the test strip guide Befsure rin gr cloth so that it is damp not wet to e uide ensure ex flid does n t Excess moisture can damage the electrical ontactS behin the test Stri CAUTION Make S uid enters the meter Do not insert any objects in the test strip guide Doing so may damage the electrical contacts behind the test strip guide 4 Letthe inside of the test strip guide air dry for at least 10 minutes with the cover off After this time re attach the test strip guide cover Make sure that the cover is properly closed You will hear it snap into place 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
69. is repeated check the result using another method e g consult with provider then collect a venous specimen and refer to an outside laboratory if requested Operating Reportable 36 96 08 80 m 7 1 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 Is the result within the established reference range if known for this patient Are results comparable to results from previous office visits Physicians and operators should question any patient test result that appears inconsistent with clinically relevant criteria or previous patient test results For example Certain drugs may affect results by interfering with warfarin pharmacology Consider the potential effect of a drug interaction with warfarin or the effect of underlying diseases e g liver disease congestive heart failure when interpreting a result Changes in the patient s diet can cause unusually low or high results Any unusual result can be followed up with inquiries to the patient and physician to define the cause of the unusual result If the result does not match the clinical symptoms repeat the patient test to rule out procedural error If the meter displays
70. kage Inserts Be sure to read the test strip package insert for important updates and keep the insert from your current test strip package for future reference The CoaguChek XS System The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy The CoaguChek XS System uses fresh capillary or nonanticoagulated venous whole blood Anticoagulation Medication Anticoagulation medications also known as blood thinners are prescribed to avoid un d clots Blood clotting time must be monitored to ensurgithat patients medication dosage is correct om lood clots is measured in units called INR It is the INR is too low the risk of blood clots increases If the INR is too high the risk for internal bleeding increases Everyone s INR is different The patient s doctor determines the best INR range for the patient depending on why the patient is taking anticoagulants and how the patient reacts to them The doctor also determines how often the patient s blood should be tested The doctor needs to know the patient s blood clotting time in order to successfully treat the patient How the System Works The CoaguChek XS Meter The CoaguChek XS System includes a meter and CoaguChek XS PT test strips Each box of test strips has its own code chip that A Display F Battery Compartment Cover you insert into the meter The code chip contains i
71. luding All patient information Dates Times Individuals involved Original and corrected results Why the erroneous result occurred 6 Maintain original and corrected reports for two years Ensuring the Security of Patient Test Results Do not allow visitors and unauthorized personnel access to the testing area where patient information may be easily viewed During the testing process keep patient test requisitions and results in an area where they cannot be viewed by visitors and unauthorized personnel Procedures for Using Alternative Methods 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 List the name of the laboratory s used if not solely dependent on the patient s insurance Follow directions from the referral laboratory for handling and transporting specimens but make arrangements for the test to be performed within 4 hours of specimen collection If this is not possible the patient may need to be sent to that laboratory for testing Communications and Laboratory Complaints lt M Record any complaints about the anticoagulation management program on the Monthly QA Checklist Include the nature of the complaint investigafive o ify t
72. ly 60 tests When testing keep the meter level When you turn the eter the display briefly shows the battery symbol The battery symbol is nts With Tk f eer p ol shows If you store the meter for a period of time remove the batteries Do not use the meter at an altitude higher than 14 000 feet 4 300 meters a Do not use the meter near a strong magnetic field such segment appears replace the a microwave oven as this may interfege with theWneter s batteries When only 1 segment appears you can proper operation still access results stored in the meter s memory Note The CoaguChek XS M Cally shuts off alter If you insert new batteries within 1 minute of removing the old 3 minutes if no buttons have 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 this manual The meter saves battery power by automatically turning off after 3 minutes unless you press a button or insert a test strip Even when the batteries are removed the test results are saved in memory Installing or Replacing Batteries Meter Setup Have ready 4 AAA batteries The CoaguChek XS Meter is preset with the U S date format sn month day year and U S time format 12 hour as opposed to 1 Open Battery Compartment With the meter turned off turn 24 hour it over Press the latch gently Before you use the me
73. lytic Testing Policies ecrit etr eren dere iube n netyeeenad EH R Eben ed pue ba E haiena 6 1 Procedures For Setting Time and Date eter iut reg SE Re eR EROR epe eura dy E P AEAN SEn pipan nines 6 1 Storing the Meter and Test Strips 00 cece cece eee eee eee eee eee eee mese semen hee ene 6 1 Code Chip Storage and Stability 0 cece cec eee e eee ee eee ee eee ee eaten seen a rhini iii ened 6 2 Ordering Test Supplles cete nno nen ur iren e Ret Rr e P RE sane Erden eui MEE EEEa seabed 6 3 Instrument Maintenance ense cta puer ee tn eh vex aa iira tede Rd bk cer ed NEE a di ebria aiuta 6 3 Onboard Quality Controls iere penuria ha Return epe E ro Ei Re DDR in ERR S RESPRDR AR RR FE REEDPEA NaS 6 3 QC Proced reS TRE 6 4 Troubleshooting Out of Range QC Resullts c cece eee ee ence ence teens ee ee eee ee eee eeeee eaters 6 4 OC Record Retention asrep acon rw eda ptc ratu a a p ROE a RD MEA AGER 6 4 Calibration Coding the Meter with the Code Chip ssssesssssmmmImHRI 6 4 Procedure for Performing Patient Tests ccccc cece ec ee ee eee ee eee eee eases eese enne 6 5 Testing Patient Samples iena iarna an a aaa En a saii 6 5 T rmaround TIME Ree PX Tr En 6 6 Procedure Notes sects dain ed ciet ut iP Recer urba enne eru E aAa aE adn uoa eo ROM XE UE Re Pa Rees EG 6 6 Limitations of the Procedure seeker nr anaana a Ra ER ReER PY RE ERR ri SE 6 6 SECTION
74. meter or parts at Roche Diagnostic s option THE ABOVE WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES AND ROCHE DIAGNOSTICS MAKES NO OTHER 1M I WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT cO LIMITATION THE IMPLIED WARRANTY OF MERCHANTABILITY r1 OR FITNESS FOR A PARTICULAR PURPOSE IN NO EVEN W PURCHASE OR USE OFT ETER N OF MERCHANTABILITY OR FI TICULAR PURPOSE IF ANY IS IMPLIED FROM THE SALE OF THE COAGUCHEK XS METER NO WARRANTY EXPRESS OR IMPLIED IF ANY The following U S patents have been granted or are pending for the SHALL EXTEND FOR A LONGER DURATION THAN THE CoaguChek XS System meter and test strips 6 662 439 7073 246 DURATION OF THE EXPRESS WARRANTY STATED ABOVE 2005 0103624 6 881 378 6 207 000 2005 0214171 2005 0123441 6 645 368 2004 0157339 2005 0129574 2005 0135968 The foregoing warranty shall not apply to a meter which is damaged by accident or subject to alteration misuse tampering COAGUCHEK and COAGUWIPE are trademarks of Roche and or abuse including the use of Dispatch products Meters which show damage or misuse will be handled in accordance with DISPATCH is a registered trademark of Caltech Industries Inc Roche Diagnostic s non warranty service policy 2006 Roche Diagnostics All rights reserved The warranty of the repaired replacement meter will expire on the date of the original warranty expiration or ninety 90 days after shipment of a replacement system whichever per
75. mplaints incidents etc Also explain any changes made to laboratory policies and procedures as a result of this Quality Assessment program Describe corrective actions taken and how changes have improved quality of the testing process Also note how pertinent staff members were involved in this quality assessment process discussions or active participation Comments Program Director Approval Date SPLIT SAMPLE LOG OPTIONAL Sample CoaguChek XS Second Accept shia Result Result Bifference Date Accepted 1 2 3 4 5 Comments Sample CoaguChek XS Second xx Accept Bate Operator Result Result DiHerence Date Accepted 1 2 3 XM 4 ll om ives Comments Sample CoaguChek XS Second m Accept Date perator Result Result kiei Date Accepted 1 2 3 4 5 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 EC T comparison lab result AAO A eVa Program Director Approval Date 9 9 SECTION 10 APPENDICES Appendices Index Appendix When to Use Page A Regulations Governing For more information about CLIA regulations state 10 2 Testing laboratory regulations and accrediting agency requirem
76. mportant B M Memory Button G Code Chip Slot information about the test strips such as their expiration date and C ON OFF Button H SET Button lot number The meter and test strips work together to provide a D Test Strip Guide Cover Data Port safe and reliable system for testing blood clotting time E Test Strip Guide The CoaguChek XS System makes measuring blood clotting time easy The display on the meter guides you through the testing process With the code chip inserted in the meter you simply insert a test strip and apply a blood sample The meter displays the result in about a minute The meter automatically stores the result in memory so that you can easily recall results The CoaguChek XS PT test strip contains various Wlgredien When a blood drop is applied t st an blood mixes with the ingredj ip When t eter determines that the blood i suj amp ment and calculates the result Getting Started Operating Conditions Refer to the Getting Started guide to learn how to set up the meter and prepare for and run your first blood clotting time test To ensure that the CoaguChek XS Meter functions correctly follow these guidelines Use the meter at room temperature between 65 F and 90 F Batteries 18 C and 32 C The CoaguChek XS Meter uses 4 AAA batteries The Use the meter at a relative humidity of less than 85 recommended batteries alkaline manganese batteries should without condensation last for approximate
77. n the comparison instrument In evaluating results as long as the bias factor remains consistent the split sample verification of results may be considered successful If statistical data is requested by the anticoagulation management program director you may fax the Method Comparison Log to the attention of Roche Diagnostics Point of Care Technical Support at 1 800 858 8075 The results will be calculated and returned within three business days Expected statistical results for accuracy are lagated on the CoaguChek XS PT Test Strips package insert 4 When the study is complete provide results to the arftico ent program director The director will determipe whether or n i ieant difference exists between the two methods and er gr d r O be informed of the bias between result the m tho u r usly and the new CoaguChek XS System Sources of Ernor in Meth parison Studies Some inherent so ror in method comparison studies include Specimen collection Incorrect volume type or concentration of anticoagulant in the collection tube The anticoagulant used should be 106 to 109 mmol L 3 1396 to 3 296 of the dihydrate form of trisodium citrate buffered or nonbuffered Other anticoagulants are unacceptable OvVverfilling or under filling collection tubes Improper filling may interfere with the correct ratio of blood to the sodium citrate dehydrate anticoagulant Failure to correct the citrate volume for persons with high 55 hematocrit Tra
78. nd set aside Send to a referral lab that is able to test it within 4 hours f using venous blood for testing on the CoaguChek XS meter remove the adapter attach a 3 cc plastic syringe and collect about 1 cc of blood into the syringe Pinch off the tubing or close the luer lock and remove the syringe Expel the first four drops of blood from the syringe Then place one drop of blood at least 10 ul from the syringe directly on the strip sample target area 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 3 If the referral lab cannot test the venous samples within four hours spin the samples according Clinical and Laboratory Standards Institute CLSI guidelines Pipette off the plasma without disturbing the cell layer into an appropriately labeled tube The referral lab may also require the original blue top to accompany the plasma _ When results are returned from the referral lab record on the Method Comparison Log Note that a bias factor is calculated on this log which is the average amount that results will differ when performed on the CoaguChek XS meter and the comparison instrument The CoaguChek XS results may be consistently lower or consistently higher tha
79. ndees to be certain that everyone is clear on every aspect of testing and is confident that they can obtain acceptable results 2 9 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 per one traini
80. ng or ongoing periodic re evaluation com u p waived 2 10 SECTION 3 METHOD COMPARISON OPTIONAL Although not required for CLIA waived tests such as the CoaguChek XS system some anticoagulation management program directors may request an evaluation to ensure that the 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 Some state regulations require method comparison before using any new method for patient testing For more information about state requirements see Appendix A If you are unsure whether method comparison is a requirement in your state for a CLIA waived test such as the CoaguChek XS system contact your state CMS office Note that method comparison is an inexact science and no two methods will provide exactly equivalent results even when testing the same patient sample Differences in reagents instruments and pre analytical variables will affect prothrombin time results so consider these factors when comparing different prothrombin time test methods For best method comparison results locate a referral laboratory that can test the patient sample within a few hours of collection and that uses one of the following laboratory reagents Dade Innovin Ortho Recomboplastin and Dade Thromboplastin C Othe ciical laboratory reagen
81. nicate any revisions to concerned staff by having them read the change in this manual and documenting this on the Policies and Procedures Approval Form page ii QA Procedures Our specific policies and procedures for ensuring quality are written throughout this Policies amp Procedures Manual and are readily available to the testing staff at all times These measures will ensure total quality throughout the preanalytic analytic and postanalytic phases of our testing program 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 Since proficiency testing is not available for the CoaguChek XS System split sampling is another equally acceptable means to externally assess the accuracy of the test system Split Sample Procedure The SAM program director will requests a periodic external evaluation of accuracy depending on How the test is used Reagent stability Manufacturer s recommendations The facility s experience with the test Currently accepted guidelines Also Maryland state regulations require 5 meter to lab comparisons three times per year Pennsylvania state regulations require split samples at least twice per year using specimens from both normal and therapeutic ranges In
82. nsport processing and sample storage Specimen storage at incorrect temperature Keep specimens at 18 C to 24 C Excessive time more than 4 hours between collection and testing Report results from both the CoaguChek XS System and the referral lab method in International Normalized Ratio INR The Mean Normal PT MNPT for the CoaguChek XS System has been predetermined through the calibration process for all strip lots The meter automatically gives results in INR based on that calibration The referral laboratory will need to establish MNPT for their system before method comparison may begin The MNPT should NOT be taken directly from the package insert for the referral lab system 3 2 SECTION 4 SAFETY IN THE TESTING AREA Safety Policies It is our intent to provide a safe testing environment for patients and staff This facility meets the manufacturer s recommendations for maintaining a testing environment to ensure instrument reliability This laboratory also meets all federal state and local requirements for safe operation To minimize problems during specimen handling test performance and reporting test results the area where testing is performed contains the proper space ventilation utilities and supplies necessary for conducting PT INR tests on the CoaguChek XS System The testing area also contains adequate lighting for visual interpretation of test results CoaguChek XS operators are offered the Hepatitis B vac
83. o the target area of the test strip Completely cover the target area Do not touch the test strip Do not introduce air bubbles move the meter or add more blood during testing Record the result according to your facility s guidelines After testing discard the needle syringe or butterfly and used test strip according to infection control guidelines 29 Memory Storing Test Results in Memory The CoaguChek XS Meter automatically stores up to 100 test results and their dates and times in its memory If the memory is full when you perform a test the oldest result is automatically deleted The most recent result is always saved Note All test results including their date and time remain in memory even when the meter is without batteries Reviewing Stored Test Results You can review stored test results even when the meter s battery power is low To review results in memory Access the Memory 30 2 View Most Recent Result The most recent test result appears The letters mem indicate that you are viewing a result in memory The time and date of the test also appear If there are no results in memory a 0 appears in the display s top right corner Earlier Results To view earlier results press the M button again di After you have viewed all the results in the memory 3 dashes appear 31 32 Erasing Stored Test Results You can erase all of the test results that are stor
84. ode chip slot until it CoaguChek XS Meter z snaps into place l Container of test strips 7 Test strip code chip CoaguChek lancet i Each box of test strips comes ao with a matching code chip Every al time you open a new box of test strips you must replace code chip Q Have the patient wash his or her hands in warm soapy water Or clean the fingertip with an alcohol wipe Make sure the fingertip Is ani thoroughly dry 2 Match Codes Make sure the code number on the test strip container and the code chip match Performing a Test 1 Get Ready Take a test strip out of the container Close the container tightly Do not open a vial of test strips or touch a test strip with wet hands or gloves This may damage the test strips You have 10 minutes to use a test strip once you remove it from the container Slide the test strip into the test strip guide in the direction of the arrows until it stops W The meter turns on The code number of the inserted code chip flashes on the display 3 Match the Code Confirm that the number displayed matches the number on the test strip container then press M M If the numbers are different make sure you are using the code chip that came with the test strips you are using amp An hourglass appears as the meter warms up which takes bout thirty seconds i When the meter is warmed up a flashing test strip appears an
85. or patients on oral warfarin therapy Disease Management and Clinical Outcomes 2000 2 Economic analysis of cost impact of systematic anticoagulation management vs ro medical care for 1000 atrial fibrillation patients on warfarin therapy Jacobson A Guilloteau F Campbell P Deaham C Comparigo int Jof i and standard reference laborato i s iy patients receiving i C y Disease Management routine warfarin th y Bh engin retrospective ana lization of anticoagulation management strategies for two point of care clinics and two control clinics that used standard reference laboratories Wurster M Doran T Anticoagulation management A new approach Disease Management 2006 4 201 209 CLIA walvedcom For more information please contact CLlAwaived Inc at 4332 Corte de la Fonda am San Diego CA 92130 Tel 858 481 5031 m Toll Free 888 882 7739 E mail info cliawaived com Visit us on the web at www cliawaived com Distributed by CLlAwaived Inc COAGUCHEK is a trademark of Roche All other trademarks are the property of their respective owners 2006 Roche Diagnostics All rights reserved 573 34186 1106
86. r TEn UNE RF EENE 4 1 Safety Precautions for the Testing Area sssssssssssssssssseeemmm ee 4 1 Safety Precautions for Working with Potentially Infectious Material sssusususs 4 1 Hazardous Waste Disposal iut exe cann E Line Cat estne pix Ra ide DRaa vado 4 2 In C se of Accident serere P eerte oos Pedo letra eg etai bea va Race bd e deduce tr ea ta an 4 2 Procedure for Reporting Device Related Adverse Events cccccceeeeeeeeeeeeeeeeeeeneeneees 4 2 SECTION 5 PREANALYTIC POLICIES AND PROCEDURES Policies for the Preanalytic Phase of Testing cccececeecee eens eee ee ee ee teens eats eeeeeeeeeeeenes 5 1 Procedures get Fest OF dm T E bss 5 1 Handling Incomplete Requisitions sssssssssssssssssses meme 5 1 Kir afe alo MO o 6 REP PR MD EDEN 5 1 Specimen Collection and Handling ccccc cece cece cece eee eee eee eee eee eee meme eere 5 1 Fingerstick Blood Collection Procedure c cceccee ec ee eee ececee eee ecee seen seen eeeeeeeaenees 5 2 Venipuncture ProCedute ccn esecepseanenus cthaceecep eres ne Rr E SR ranan EPEE Eh YEN a 5 3 Specimen Handlings Lc EUM 5 4 Specimen Accessioning ssssssssssssssssssssses esee e esee ee hene mesi nisse iere tese see rennen 5 4 Specimen Rejection Criteria lesse meme eme e eee emen eee ene 5 4 SECTION 6 ANALYTIC POLICIES AND PROCEDURES Ana
87. rding the time and date of testing and having written instead of verbal test orders from the ordering physician Proper specimen collection and handling is also an essential component of our preanalytic policies It is the policy of our anticoagulation testing program to adhere to the following procedures which govern all activities from the time tests are ordered through the time that specimens are received and processed at the testing site Procedures for Test Ordering An order for a PT INR test may be placed on the patient chart the superbill or on a test requisition form 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 ofer is given to a CoaguChek XS operator the patient chart or a written test requisiti UON enatec by the end of the day Check one Ve C ions L This facili s patient wal L This fadffity us s supdibill as t amp amp t Yequisitions isiti testr is attached and is located Handling Incomplete Requisitions When patient is brought to the testing area accompanied by an incomplete requisition the ordering physician or his her nurse is questioned to provide the missing information This information is recorded on the Monthly QA Checklist so we can keep track of problems with this aspect of our testing program If needed procedures will be changed to decrease the occurrence of incomplete requisitions Standing
88. re stringent regulations than the Appendix A 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 Step 3 Optional If required by state regulations or if the SAM program director Section 3 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 amp for testing Strike through those procedures that are not performed in Procedure Manual your facility initial and date this change or add verbiage to ind ate additional procedures that pertain to your SAM program om C Section 1 The SAM program director signs the Policie r Page ii Approval Form to accept tise customi rgcedu Step 5 Ensure that all operators Wave trai orm patient tests File Section 2 the complet oaguChek X r Certification Checklist and Operator Gertification Test Be sure re aware of the key points specified in this Section 1 Policies amp Procedures Manual and have signed the Policies amp Procedures Approval Form Once Testing Has Begun Each Day of Testing Ensure that on board QC results are ac
89. rmine whether to recall retest re 7 4 evaluate or re release patient test results The anticoagulation management program director will also determine how to notify patients staff and referring physicians If the incident is believed to have resulted from an instrument malfunction the incident may need to be reported to the FDA If the event is death make the report both to the FDA and the device manufacturer If the event is serious patient injury the report may be made to the manufacturer only Submit FDA Form 3500A http www fda gov opacom morechoices fdaforms cdrh html no later than 10 working days from the time personnel become aware of the event Procedure for a Power Failure The CoaguChek XS meter can operate only with four AAA batteries The batteries should last for about 60 tests depending on the type of battery used Therefore a power failure will not affect the CoaugChek XS meter To save power the CoaguChek XS meter automatically turns itself off after three minutes unless a button is pressed or test strip is inserted Replacing the Batteries When replacing the batteries replace all batteries at the same time Insert the new batteries within 1 minute of removing the old ones to keep the date and time settings If you 2 longer than this you may need to re enter the date and time 1 ved com a SECTION 8 QUALITY ASSESSMENT QA Policies This Quality Assessment QA Program comprises the steps taken to as
90. rrectly discard and redraw After filling the vacuum tube remove the tube from the adapter gently mix the contents and set aside Send to a referral lab that is able to test it within 4 hours If using venous blood for testing on the CoaguChek XS System remove the adapter attach a 3 cc plastic syringe and collect about 1 cc of blood into the syringe Pinch off the tubing or close the luer lock and remove the syringe Expel the first four drops of blood from the syringe Then place one drop of blood at least 10 ul from the syringe directly on the strip sample target area Record the result from the CoaguChek XS System on the Split Sample Log FORMS Section For the purpose of this study repeat any CoaguChek XS System 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 Split Sample Log 5 If the referral lab cannot test the venous samples within four hours spin the samples according Clinical and Laboratory Standards Institute CLSI guidelines Pipette off the plasma without disturbing the cell layer into an appropriately labeled tube The referral lab may also require the original blue top to accompany the plasma When results are returned from the referral lab record on the Split Sample Log A bias factor calculated on the Split Sample Log is the average amount that results will differ when performed on the CoaguChek XS meter and the
91. s samples for testing on the CoaguChek XS system Use af least gauge needle or larger in size CO Remove a test strip from iis container sh b g the venipuncture ine if sample must be applied to the test strip trip from its container Immediately re captthe within utes Of re 3 Prepare the Patient Wash hands an gloves Reassure the patient that although the venipuncture may be slightly painful it won t last long Position the patient with the elbow extended and the arm supported Have the patient make a fist but avoid vigorous hand exercise pumping Apply the tourniquet about 3 4 inches above the venipuncture site Do not stop the blood flow for more than one minute before the blood is drawn If necessary release and reapply the tourniquet 4 Select and clean the venipuncture site The median antecubital and cephalic veins are most commonly used Avoid the following areas 1 Scarred areas such as healed burns 2 Thrombosed veins These veins feel thick and cord like and tend to roll 3 Bruised areas If you cannot avoid collecting from a bruise site then draw the specimen from the site farthest away from the bruised area 4 The arm on the side of a prior mastectomy Because this surgery results in lymphostasis specimen collection may be difficult 5 n a dialysis patient do not collect from the arm that has the A V shunt 6 Arecent IV site or the same side of the body as the IV site 5 3 Clean the venipuncture
92. sponds according to its established food drug interaction program A T When heparin is administered intravenously and continuously the organization uses programmable infusion pumps M C 8 The organization has a policy that addresses baseline and ongoing laboratories tests that are required for heparin and low molecular weight heparin therapies M C 9 The organization provides education regarding anticoagulation therapy to staff patients and families M C 10 Patient family education includes the importance of follow up monitoring compliance issues dietary restrictions and potential for adverse drug reactions and interactions A 11 The organization evaluates anticoagulation safety practices see MM 8 10 10 5 Evaluation of the Accuracy and Precision of the CoaguChek XS System This paper summarizes a study conducted to evaluate the performance of the CoaguChek XS System compared to traditional laboratory methods for PT INR testing Y IN W A ivedor Jennifer L Fuller MS CCRA and Earl Miller MS Roche Diagnostics Corporation Indianapolis IN INTRODUCTION The CoaguChek XS System is a third generation portable monitor used for prothrombin time PT testing with results typically provided in International Normalized Ratio INR units It is intended for use by healthcare professionals to evaluate the PT INR of individuals using oral anticoagulants e g warfarin Careful monitoring of patients on warfarin ther
93. ssseseeeee 8 3 SECTION 9 FORMS Forms IMGIOX since T M 9 1 CoaguChek XS Operator Certification Checklist esses 9 2 Operator Certification iest oreet eee srt i Rosi hens e pega nar REALEN E E iina ma ced Eart 9 3 CoaguChek XS Operator Evaluation Checklist Optional sssssssseseseeeesse 9 5 CoaguChek XS Method Comparison Log Optional sssssssssesessseeseeeeeeee 9 6 CoaguChek XS Patient Test Log sssssssssssssssssesemme ene emen emere 9 7 Monthly QA Checklist m ELM 9 8 Split Sample Log Optional rentrer I apr aa E EA AERAN TN EER 9 9 SECTION 10 APPENDICES Appendices Index tee etras accel red ces Ari RR nm ERDRPRaMk RP aa a a RAE aitai aini daeina 10 1 Appendix A Regulations Governing Testing sssssssssssssssesee mee 10 2 Appendix B Joint Commission Anticoagulation Therapy National Patient Safety Goals 10 5 Maid 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 Step 2 If your facility does not currently hold a CLIA certificate apply to the CLIA Appendix A program for a certificate of waiver If your facility already has a CLIA certificate no action is necessary Step 3 If your facility is located in a state with mo
94. st Strip Unusable Solution Error Code Chip Solution The code chip is missing not properly inserted or damaged eter The test strip is unusable Turn the meter off remove the test strip and then uo C300 re insert it If the error eode error error message reappears discard a id p the unusable test strip and u If the code chip is damaged use a new one call Roche Diagnostics l S Technical Service Center at 1 800 428 4674 42 43 44 Error Messages You May See After You Apply Blood Error Time Exceeded You did not apply blood to the test strip within 2 minutes after the blood drop symbol appeared Error Blood Application Error applying blood to the test strip error b p id b kr Solution Turn the meter off and remove the test strip Repeat the test using the same test strip and blood taken from a new fingerstick from a different finger n the meter off and remove the test strip Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger Error Test Strip Interference The test strip was touched or removed during the test Th test strip failed the internal quality control check The test strip is unusable error Solution Solution Turn the meter off and remove the test strip Repeat the test using a new test s
95. stick and venipuncture and were analyzed on a CoaguChek XS System using a human recombinant thromboplastin calibrated to an ISI of 1 0 The lab reference sample was obtained using a 3 2 sodium citrate Vacutainer and was run on a Sysmex analyzer using Dade Innovin thromboplastin To cover as much of the reading range as possible the study included 100 patients per site who were being treated with warfarin therapy and 20 patients per site who were not RESULTS DISCUSSION Precision The numerical results for the capillary and venous whole blood precision of patient duplicates are shown in Tables 1 and 2 a visual representation is provided in Graphs 1 and 2 Acceptable results were obtained for both capillary CV x7596 and venous CV lt 4 5 blood Table 1 CoaguChek XS System Capillary Blood Precision Lot 022 INR N Mean SD 9o CV 2 0 103 1 31 0 05 4 05 gt 2 0 3 0 131 2 49 0 11 4 33 gt 3 0 4 5 87 3 50 0 12 3 54 gt 45 23 5 51 0 23 4 18 Entire Range 344 2 59 0 11 KN 4 35 or Table 2 CoaguChek XS System t hf ibn Lot 022 Sam yp an SD 9o CV 0 9 1 30 0 04 2 76 gt 2 0 3 0 132 2 49 0 07 2 62 gt 3 0 4 5 92 3 49 0 07 1 96 gt 45 24 5 54 0 11 1 90 Entire Range 357 2 59 0 06 2 42 Graph 1 CoaguChek XS System Capillary Blood Precision Lot 022 Difference Between Replicates Whole Blood Precision for Capillary Blood Lot 2 s o
96. sure the overall reliability of our anticoagulation management program starting with proper specimen collection and ending with interpreting patient test results and taking the appropriate patient management decisions based on test results Unlike quality control which monitors the test system only QA involves the entire testing process including safety personnel specimen collection and handling performing the test recording results and finally reporting patient test results to providers The Monthly QA Checklist is a means of ongoing assessment which helps to evaluate how well our systematic anticoagulation management program is working The anticoagulation management program director oversees the implementation of the QA plan and helps identify and correct problems as they occur The QA process involves investigation identification and resolution of any problems with subsequent development of policies that will prevent recurrence These new policies will be periodically reviewed to ensure the actions taken corrected the initial problem over time XM com a i ludin chart review portion If an e act Once a month complete the Mont ion on the Monthly QA Checklist measure was not taken h item is marked no take actio d Action to take inv lves d termining Wwhy i When necessary T vis the policies and procedures in this Policies amp Procedures Manual based on problems identified on the Monthly QA Checklist Commu
97. ter for the first time or if there is no battery inward and lift the cover power for more than 1 minute you ll have to set the current date Remove the old batteries and time In addition the meter has certain advanced features that if necessary you can set up if you ME use them See the Advanced Features section in this manu 1 Warn more about the advanced features and how to set th eu Th ydate and time settings are important Each time you run a test the meter compares its date with the test strip s expiration date If the test strips are expired the meter displays an error message and prevents you from running a test Whenever you put batteries in the meter it automatically goes to Setup mode where you set the date and time You can also go to Setup mode at any time by pressing the SET button 2 Insert New Batteries To set the date and time you ll use these buttons I to change a setting 3 Turn Off Turn the meter off to accept a setting 1 Go to Setup Mode If the meter is not already in pan v3 The tine format tisshes in the Setup mode press the SET HAS upper left corner button f 3 Set Current Time p M Press the SET button ress the M button cy to ange the hour Press the qma T button Press the M button cy to change the minutes Press the SET button The date format flashes in the upper right corner ress the SET button 4 Turn
98. 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 accu CoaguChek XS operators are to report any situation thatfcou compromise employee or patient safety to the an al i t program director The anticoagulati t e tor ensures that C gem Test meth dologi e quality results and are adequate to determine accuracy precision h r 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 opera
99. this facility split sampling check one L Is performed Frequency L Is not performed A procedure for split sampling follows 1 Select one or more operators to perform split sampling Attempt to rotate these duties so that all operators can periodically perform this exercise 2 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 Note The Mean Normal PT MNPT for the CoaguChek XS System has been predetermined through the calibration process for all strip lots The meter automatically gives results in INR based on that calibration The referral laboratory will need to establish MNPT for their sys efore method comparison may begin Do not take the MNPT directly from the packageffisert f vero lab system CO 3 Select 5 patients to compate In pati Aly erapy and nonsmoking healthy patients who oton waffari in er ny other medication that affects clotting Do not include patieafs who Gre on rin therapy 4 From each patient venous blood specimen Use a butterfly collection set with a 3 2 citrate blue top vacuum tube installed make sure you have the correct adapter on the end of the butterfly tubing Fill to the appropriate fill line Under filling or overfilling can affect test results so if the tube is not filled co
100. tional Sensitivity Index ISI Thromboplastins with lower ISI values are said to be more sensitive to factor deficiencies Generally a manufacturer of a commercial thromboplas tin reagent assigns an ISI to the reagent The INR is calculated according to the following formula INR patient PT mean normal PT 5 The patient PT is the patient result in seconds the mean normal PT is the normal PT as defined by the manufacturer and the ISI is the International Sensitivity Index assigned to the reagent Precision The precision of a system is its ability to replicate measurements to give similar results Whole blood precision was analyzed separately for normal donors those patients T warfarin and war farinized donors The study measured precision for both ca illa eor blood on the CoaguChek XS system Ve P A For the capillary testiag the investig fo ate fingerstick the first drop was applied to one CoaguCheKyXS mohitor aridi tlie sec drop was applied to a second CoaguChek XS moni tor A rotation sc e wa t6 ensure that the same instrument was not always dosed first For the venous testing was applied from a syringe no rotation scheme was used Accuracy The accuracy of a system is evaluated by performing a method comparison The samples are ana lyzed on the method under evaluation and the results are compared to the results from a standard laboratory reference In this study the portable monitor samples were obtained by finger
101. titutional 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 3 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
102. tors have documented evidence of training CoaguChek XS Operator Certification Checklist and Operator Certification Test before testing patient samples This Policies amp Procedures Manual is available to CoaguChek XS operators CoaguChek XS operators have signed the Policies amp Procedures Approval Form on page ii Any time there is a change in the test procedure or any other part of the anticoagulation management program personnel are notified and signify their understanding by signing the Policies amp 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 2 1 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 and Operator Certification Test CoaguChek XS Operator Responsibilities Testing analysts Perform test methods as specified following this facility s procedures for specimen handling and processing test performance and reporting and maintaining records of patient results
103. trip and blood taken from a new fingerstick from a different finger Do not touch or remove the test strip when a test is in progress Turn the meter off and remove the test strip Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger 45 Error Measurement Error Solution Error Internal Error Solution Measurement error caused Do not touch or remove the test An error occurred during the Turn the meter off and by the blood sample strip when a test is in progress internal diagnostic test remove the batteries Wait Be sure to apply the blood drop at least 1 minute before m to the test strip within 15 seconds m r isi the batteries in ul of sticking the fingertip the battery compartment N y PR l a Re set the date and time as A i Foie cases EOT Mesue 7 m described in the Meter Setup I S can occur in patients with long lt x section at this manual coagulation times gt 8 INR If 1M this error message appears again Caution The date and time when the test is repeated the M be set correctly result must be checked using co epeat the test If you see the another method same error message again The CoaguChek 6 PT te ip Way be used for pati i the ticoagulatits pl irvinjections UadeFno the meter has a defect ould heparinized ry tubes be used for sample application If capillary tubes are used please use only the dedicated CoaguChek capillar
104. ts may not consistently correlate with the CoaguGhek X cor referen Iy Aer WHO International iv rsal INR results the Mean Normal S meter has been established at 12 seconds established at 1 0 Each lot of test strips is calibrated to Reference Preparations For th pu Prothrombin Tim and the ISI for th systermhas If the anticoagulation management program director of the anticoagulation management program wishes to do this comparison a sample Method Comparison Split Sample Analysis procedure follows Suggested Procedure for Method Comparison 1 Select at least 20 patients to compare About of the samples should be from patients on warfarin therapy evenly distributed and selected so that INRs throughout the therapeutic range are represented About of the total method comparison samples should be from nonsmoking healthy patients who are not on warfarin aspirin or any other medication that affects clotting Do not include patients who are on heparin therapy in this study 2 From each patient collect a venous blood specimen Use a butterfly collection set with a 3 2 citrate blue top vacuum tube installed make sure you have the correct adapter on the end of the butterfly tubing Fill to the appropriate fill line Under filling or overfilling can affect test results so if the tube is not filled correctly discard and redraw After filling the vacuum tube remove the tube from the adapter gently mix the contents a
105. use the CoaguChek XS meter for testing patients being treated with any direct thrombin inhibitors including Hirudin Lepirudin Bivalurudin and Argatroban Do not add additional blood sample to the test strip once the testing has begun 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 5 5 SECTION 6 ANALYTIC POLICIES AND PROCEDURES Analytic Testing Policies In order to ensure accurate and reliable test results testing must be performed properly with special attention to quality control and instrument maintenance It is the policy of this facility to follow the manufacturer s written instructions regarding the operation and maintenance of the CoaguChek XS System found in this Policies amp Procedures Manual and also in the CoaguChek XS PT Test Strip package insert and the CoaguChek XS User Manual Always refer to the latest Test Strip package insert since changes may occur over time Moreover this Policies amp Procedures Manual does not reiterate all that is contained within these documents Rather the analytic procedures below condense and organize the materials provided by the manufacturer so that they can be used on a daily basis In this facility only operators who are qualified under CLIA and who have documented evidence of training perform testing on the CoaguChek XS System Meter Settings Indicate the selections esta
106. within ten minutes of removing the test strip from its container Collect the blood sample lt M f possible ask the patient to wash his hands prior to testing Warm the patient s hand by having the patient wash thej d rm water Ask the patient to let his arm hang down for s lancing his finger Wash hands and don gloves Massage thegpatients fihge its e fingertip has increased color Clean thefelectead fingelitojbe la th an alcohol wipe Allow to air dry Prepare lanc lidevic cording to the manufacturer s instructions Insert test Stuipsint the meter When the meter displays the flashing test strip and blood drop symbols with the hand still down stick the side of finger with a lancet Immediately after lancing massage gently along the side of the finger to obtain a good blood drop without pressing or squeezing too hard The minimum sample size is 10 ul of whole blood For PT INR testing on the CoaguChek XS system do NOT wipe away the first drop of blood Proceed to step 5 if you plan to apply the blood directly to the strip OR to step 6 below if using a CoaguChek capillary tube Hold the blood drop directly onto the test strip within 15 seconds of the fingerstick until the meter beeps if beeper is set to ON Do not apply a second drop of blood or disturb the strip while testing Or Touch a CoaguChek Capillary tube to the blood drop Keep capillary tube level and allow it to fill half way b
107. y capillary action Avoid getting air bubbles into the capillary tube Do not touch the bulb during sample collection If blood gets into the capillary bulb during sample collection discard the bulb 5 2 Put finger over hole in the capillary bulb and hold capillary tube directly over sample target area While the test strip and blood drop symbols are flashing on the display place one drop onto the test strip within 15 seconds of the puncture Note Since the CoaguChek XS PT Test is performed immediately after specimen collection labeling the patient s blood sample is not feasible Therefore it is critical to positively identify all patients to be tested with the CoaguChek XS System Venipuncture Procedure 1 Identify the patient Identify patients by having them or a guardian state their full name and another identifier such as date of birth If more than one patient is present with the same first and last name look for possible gender differences social security number patient identification number birth date different middle name and relevance of the test to the patient s history In this facility the second patient identifier is a Move the patient to a location where his arm can rest comfortably while remaining straight a Explain to the patient the purpose and steps of the procedure 2 Select the appropriate collection supplies Use a plastic syringe with no additives or anticoagulants fgr t llection of venou
108. y of the CoaguChek XS Operator Certification Checklist and Operator Certification Test 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 M The CoaguChek XS System Getting Started Guide CO Package inserts for test strips and instructions folllanceis To order additional copies of these ing f t e Diagnostics Technical Service Center at 14 28 4674 O d them from www poc roche com Document persolinel trai n CoaguChek XS Operator Certification Checklist and Operator CertificatiemsTeSt 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 amp Procedures Manual and also in the CoaguChek XS package insert and CoaguChek XS User Manual For ins
109. y tubes 46 Other Information Ordering Information for Health Care Product Specifications Professionals Operating Conditions Please contact Roche Diagnostics Customer Service at 1 800 428 5076 Temperature 65 F to 90 F 18 C to 32 C Relative humidity less than 85 without condensation REF Cat Number Maximum altitude 14 000 feet 4300 m CoaguChek XS System 04837975001 Placement Operate the meter on a level vibration free includes carrying case ee or hold it so it is roughly orizontal CoaguChek XS PT Test 04625315160 EMeasu i n 4 t trip package insert RAMS a st results with date and time Infrared interface LED IRED Class 1 4 AAA batteries set of batteries Approx 60 tests CoaguChek Lancets 04348150001 Box of 200 Battery operation Capillary Tubes Bulbs 1162 173001 Number of tests per 045 CoaguWipe Bleach Towe Safety class Automatic power off After 3 minutes Dimensions 5 43 x 3 07 x 1 10 in 138 x 78 x 28 mm Weight 4 48 oz or 127 g without batteries Product Limitations Please read the information packaged with the test strips regarding up to date product specifications and limitations 48 49 50 Sample Material Sample type Capillary whole blood or non anticoagulated venous whole blood Sample size At least 10 uL Interference Refer to the test strip package insert Non Operating Storage and

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