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1. In order to limit the size of the error Beckman Coulter is restricting the room temperature requirements for running the affected assays on the Access Immunoassay systems The restricted room temperature ranges will not completely eliminate the temperature based error but will limit the size of the error Beckman Coulter is currently working on a more permanent solution to eliminate the error completely The restricted temperature ranges and the estimated maximum error that will be seen as the room temperature varies across these ranges are shown in the table below examples of the expected error with temperature variation are shown in the attached Questions and Answers pages 4 and 5 AccuTnI results should not be reported out of the laboratory when the ambient room temperature exceeds the restricted range in the table Cortisol and Triage BnP should be recalibrated if the room temperature changes by more than 4 C 7 2 F from the room temperature at which the assay calibration was established TM Part Product Restricted result error If temperature temp range across restricted range increases assay result 33340 Access AccuTnI 21 28 C 69 8 82 4 F 24 Decreases A78803 Access AccuTnI 21 28 C 69 8 82 4 F 24 Decreases 33600 Access Cortisol 4 C 7 2 F 6 Increases 98200 Triage BnP Test for Beckman Coulter Immun
2. Cortisol the result shifts by approximately 1 5 for every 1 C 1 8 F change in room temperature The errors on the Access Cortisol and Triage BnP assays are caused when the room temperature changes from the room temperature at which the assay was calibrated therefore recalibrating these assays when the room temperature changes can reduce the size of the error on sample results However results for the AccuTnI assay are affected differently by a room temperature shift than the Cortisol and Triage BnP results The AccuTnI result is dependent on the room temperature at the time the sample is tested regardless of the room temperature at the time the assay was calibrated Please be aware that since the magnitude of the error for the Access AccuTnI result is independent of the room temperature during assay calibration re calibrating the assay will not affect the results or reduce the magnitude of the error This means that all AccuTnI results will be affected to some degree by this malfunction Any results generated when the room temperature is below 24 C 75 2 F will be falsely elevated and any results generated when the room temperature is above 24 C 75 2 F will be falsely decreased For all of these assays controls may not detect these errors and cannot be relied upon to ensure that your device is not generating erroneous results due to changes in the ambient room temperature
3. downloaded from www fda gov MedWatch getforms htm by mail to MedWatch 5600 Fishers Lane Rockville MD 20852 9787 or fax 1 800 FDA 0178 COAGUCHEK is a trademark of Roche Bristol myers Squibb Initiates a nationwide Voluntary recall of Coumadin Warfarin Sodium CRYsTALLIne 5 MG TABLeTs LOT nuMBeR 9H49374A 1FOR IMMeDIATe ReLeAse May 2 2011 Bristol Myers squibb initiated a voluntary recall of one lot of 1 000 count bottles of Coumadin warfarin sodium Crystalline 5 mg tablets Bottles of 1 000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities The lot number affected in the u s is 9H49374A with an expiry date of september 30 2012 The recall is a precautionary measure based on the company s testing of tablets from a returned bottle A single tablet was found to be higher in potency than expected Coumadin is prescribed to treat or prevent blood clots A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient there is an increased risk of bleeding Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so should consult their physician for appropriate medical adv
4. shows an error message error message 4 or 8 and no test result is displayed error 4 the test strip is unusable error 8 an error occurred during the internal diagnostic test In rare cases a positive bias of the patient s test result with or without an error message is displayed Cleaning and disinfecting with certain cleaning agents has been identified as the root cause especially if applied near the test strip guide cover Liquid entering the meter s housing can cause damage to the meter CLINICAL sIgNIFICANCE Positive deviations of gt 30 are possible therefore there is a remote risk for incorrect treatment due to falsely elevated results Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients and to determine if any clinical intervention is needed for patients that have been treated based on these results uPDATED METER CLEANINg INsTRuCTIONs In order to avoid the issue outlined in this urgent Medical Device Correction uMDC update Roche Diagnostics recommends separate cleaning instructions for cleaning disinfecting the meter housing and cleaning the meter test strip guide All cleaning and disinfecting solutions detailed in this uMDC update are commonly available at medical supply distributors or drug stores Failure to follow these procedures may cause a cleaning related malfunction of the met
5. 800 981 9883 This publication may be obtained through enrollment in a COLA accreditation program or by subscription for 48 per year ALL RIGHTs ReseRVeD Reproduction in whole or in part without written permission is prohibited www cola org www Labuniversity org www COLAcentral com COLA s insights MAY June 11 24 COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 25 Thank you The University of Wisconsin School of Medicine and Public Health and COLA thank the following companies for their financial support of the Symposium for Clinical Laboratories a celebration of COLA Spring 2011 Symposium EDUCATION Coagulation WORDseARCH D s A M s A L P Y B Q Z e x Y n I T s A L P O B M O R H T A F O R e L R Z Z e n A W G P W H I I x L M e x u C n H n O H e e B T u e T V F L I O I R T F C M R A R T O I n R L D T A I A e A I M T A e L A e e A P s s C n T n R Z L A F B e B n I P s T I O O O x P R L L L O I I M O O u M G F W A O B e M C A P T T R u A e T W O I W M C I s n I R T n I n O D C B O C O u M A D I n Y Y F L I D C P R O T H R O M B I n Z C n n K n I M A T I V B R u I s e R APTT BLee
6. htm accessed May 2011 The IsI value is critical in the calculation of the INR since it is the exponent in the formula which means that even small errors in assigning the IsI value can result in substantial errors in the INR calculation COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 11 COnTInueD FROM PAGe 5 COMPARIsON OF POINT OF CARE COAguLATION sysTEMs COAGuCHeK s sYsTeM since 1994 Roche Diagnostics CoaguChek systems have set the standard for precision in point of care prothrombin time PT InR testing for patients on oral anticoagulation therapy giving clinicians confidence in making critical treatment decisions The CoaguChek s system is an easy to use quantitative PT InR test that utilizes fresh fingerstick capillary or non anticoagulated venous whole blood Just turn on the monitor insert a test strip and apply a sample of whole blood when directed Results are displayed approximately one minute after sample application The results are then stored in the monitor s memory for easy retrieval later Obtaining accurate PT InR results quickly at the point of care helps enable healthcare professionals to make immediate therapy adjustments discuss them with the patient and document treatment decisions all in one appointment Multiple studies have shown that a systematic ap
7. included in this recall Physician sample Blister Packs Lot 9A48931A 9A48931B 9A48931C expiration January 2012 HuD Blister Pack Lot 8F34006B 8K44272A 8K46168A 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012 The recall is a precautionary measure based upon the company s determination that some of the tablets over time may not meet specification for isopropanol Isopropanol is used to maintain the active ingredient Coumadin in the crystalline state and could affect the therapeutic levels of the active ingredient Coumadin is prescribed to treat or prevent blood clots A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient there is an increased risk of bleeding The recall only involves Coumadin 1 mg tablet blister packs distributed in the u s This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product Patients who may have product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted To date the company has not received any reports of adverse events related to this issue Bristol Myers squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately The
8. Contact Roche Diagnostics Point of Care Technical service at 1 800 820 0995 if error 4 appears when turning on the instrument the first time after cleaning disinfecting error 8 appears during the first measurement after cleaning disinfecting error 9 appears or if you have questions regarding the reliability of your results For subsequent error 4 or error 8 messages unrelated to cleaning follow the instructions provided in the user s Manual If the error persists contact Roche Diagnostics Point of Care Technical service at 1 800 820 0995 File this urgent Medical Device Correction uMDC update for future reference Discard urgent Medical Device Correction 09 111 QuEsTIONs Please contact Roche Diagnostics Point of Care Technical service at 1 800 820 0995 if you have questions about the technical information contained in this urgent Medical Device Correction update Please call 1 866 625 5325 for questions regarding the replacement of your meter s This uMDC update is being conducted in cooperation with the u s Food and Drug Administration FDA Any adverse reactions experienced with the use of this product and or quality problems should also be reported to the FDA s MedWatch Adverse event Reporting program online at www fda gov MedWatch report htm by phone 1 800 FDA 1088 or by returning the postage paid FDA form 3500 which may be
9. InR Therefore the InR target range is patient specific For most indications however a target range of 2 0 to 3 0 is usually recommended Higher InR values 2 5 to 3 5 are recommended for patients with prosthetic heart valves since the possibility of clotting and embolus production is higher in these patients The patient s medication dosage should be adjusted to maintain the appropriate target range since too much medication can result in excessive bleeding and too little can result in clot formation OTHeR InR InFLuenCes some medications can affect the PT InR result Certain antibiotics have been shown to increase the result while certain barbiturates oral contraceptives and hormone replacement therapy drugs have decreased PT InR results Alcohol dietary supplements and foods rich in vitamin K beef and pork liver green tea broccoli chickpeas kale turnip greens and soybean products can also alter PT InR results Thus it is important to interview patients to see if they have experienced any dietary or medical changes whenever InR results are being evaluated n ResOuRCes Lab Tests Online A public resource on clinical lab testing from the laboratory professionals who do the testing http www labtestsonline org accessed May 2011 PTInR America s Anticoagulation Resource http www ptinr com accessed May 2011 emergency nursing World http enw org Research InR
10. LQC Liquid Quality Control materials external controls As of July 2010 Roche Diagnostics has re filed revised labeling with the FDA in an effort to obtain waived status COLA s insights MAY June 11 14 UrgEnt medical Device Correction Update CoaguChek XS and CoaguChek XS Plus meters CLeAnInG ReLATeD MALFunCTIOn OF MeTeR POTenTIALLY LeADInG TO FALseLY eLeVATeD PT InR ResuLTs uPDATE urgent Medical Device Correction 09 111 has been updated with the following Modified disinfecting solutions for the meter outer housing Cleaning Verification section added Meter Modifications section added Meter Replacement section added IssuE Internal investigations have confirmed that previously recommended cleaning procedures can lead to falsely elevated PT InR results on CoaguChek xs meters with serial numbers below uP0400000 and CoaguChek xs Plus meters with serial numbers below uQ0040000 In rare circumstances these procedures can cause electrical bridging between heater pins in the CoaguChek xs and CoaguChek xs Plus meters The electrical bridging between the pins may cause the instrument to read the incubation temperature as having reached 37 C 98 6 F when in reality the heater temperature is lower This causes coagulation to start at too low of a temperature leading to falsely elevated PT InR results If a meter is affected by this problem in the vast majority of cases it
11. a minute The results are automatically stored in the meter s memory and can be easily recalled n ResOuRCes 1 Hemochron signature http www itcmed com ProTime http protimesystem com pro_main html 2 CoaguChek systems http www poc roche com gt see page 12 for a Comparison of Point Of Care Coagulation systems Chart COLA s insights MAY June 11 12 COnTInueD FROM PAGe 11 COMPARIsON OF POINT OF CARE COAguLATION sysTEMs COMPANy ITC Instrument Hemochron signature Plus Hemochron signature Elite ProTime sample Fresh or citrated whole blood Fresh or citrated whole blood Fingerstick whole blood sample Volume One large drop One large drop One large drop Analysis Time Varies according to test Varies according to test 3 4 minutes Quality Control Functional self check temperature Functional self check temperature Functional self check verification self check plus optional verification eQC internal cuvettes have integral cartridge check eQC cartridge optional LQC test cuvette QC 2 level QC optional LQC optional LQC test cuvette QC Data entry Keypad Keypad and barcode scanner Display screen prompts Data storage 400 patient amp 400 QC results 600 patient amp 600 QC results Data sharing Instrument ports and or separate Instrument ports and or separate separate software software allow data t
12. click here http www bms com documents news features HuD_Coumadin1mg_recall_letter pdf COLA s insights MAY June 11 18 Urgent Field Safety notice Product Correction ACCess IMMunOAssAY sYsTeMs ATTENTION ACCEss IMMuNOAssAy CusTOMER This letter contains important information that requires your immediate attention regarding updated room temperature operating requirements for your Access Immunoassay systems which can impact assay performance PRODuCT RIsk Access AccuTnI Access Cortisol and Triage BnP Test for Beckman Coulter Immunoassay systems assays can produce inaccurate results when performed within the published Access Immunoassay systems room temperature operating specification of 18 C to 32 C 64 4 F to 89 6 F Beckman Coulter has concluded that an increase in room temperature causes Access AccuTnI and Triage BnP assay results to decrease and a decrease in room temperature causes assay results to increase Internal investigations have concluded that for Access AccuTnI the result shifts by approximately 3 5 for every 1 C 1 8 F change in room temperature For Triage BnP the result shifts by approximately 3 0 for every 1 C 1 8 F change in room temperature Conversely an increase in room temperature causes Access Cortisol assay results to increase and a decrease in room temperature causes assay results to decrease For Access
13. of test results with date and time entry of Patient ID and or Operator ID and printing of results HeMOCHROn Configuration Manager software included with the system allows the user to connect a personal computer to an instrument and perform system configuration functions using the fast and convenient Microsoft Windows user interface ITC data management software programs available separately allow the user to connect a personal computer to an instrument and perform various data management and data reporting functions HeMOCHROn sIGnATuRe eLITe The ITC Hemochron signature elite is a simple easy to use portable microcoagulation system that can enhance compliance and patient safety Hemochron s extensive menu allows for the standardization of point of care coagulation throughout the facility The signature elite integrates data management and connectivity and connects to most major data management systems It is a small battery operated hand held instrument that performs individual point of care coagulation tests on fresh or citrated whole blood These tests include Activated Clotting Time ACT and ACT LR Activated Partial Thromboplastin Time aPTT and aPTT Citrate and Prothrombin Time PT InR and PT InR Citrate The system is intended to be used only with test cuvettes that are available from ITC Data management capabilities of the instrument include storage of up to 60
14. related malfunctions error 9 This new fail safe feature produces an error 9 message prior to blood application in the event of a cleaning related malfunction heater subassembly modifications to prevent cleaning solutions from contacting the heater pins CoaguChek Xs meters equipped with the modifications will begin with serial number uP0400000 CoaguChek Xs Plus meters equipped with the modifications will begin with serial number uQ0040000 Correct Incorrect gt gt CONTINuED ON PAgE 16 COLA s insights MAY June 11 16 Voluntary recall COnTInueD FROM PAGe 15 COAguCHEk Xs AND COAguCHEk Xs PLus METERs METER REPLACEMENT Once available Roche Diagnostics will replace CoaguChek xs meters with serial numbers below uP0400000 and CoaguChek xs Plus meters with serial numbers below uQ0040000 with meter s that have the modifications described above Roche Diagnostics will begin shipping replacement meters in Q1 of 2010 Continue to use your existing CoaguChek Xs or CoaguChek Xs Plus meter s along with the updated cleaning disinfecting procedures outlined in this uMDC update until you receive your replacement meter s ACTIONs REQuIRED Please call 1 866 625 5325 to arrange the replacement of your meter s Continue to use your existing CoaguChek xs or CoaguChek xs Plus meter s along with the updated cleaning disinfecting procedures outlined in this uMDC update
15. temperature are corrected by recalibration We recommend that you recalibrate if the room temperature changes by more than 4 C 7 2 F between the time you calibrated the assay and the time you are ready to analyze samples For Access Cortisol recalibrating when the temperature changes by more than 4 C will limit the maximum result error to 6 For Triage BnP recalibrating when the temperature changes by more than 4 C will limit the maximum result error to 12 gt gt CONTINuED ON PAgE 20 COLA s insights MAY June 11 20 COnTInueD FROM PAGe 19 uRgENT FIELD sAFETy NOTICE PRODuCT CORRECTION 3 Can I rely solely on my quality control results for individual assays to detect changes in assay performance due to temperature Certain quality control results may not be affected by room temperature change to the same degree as patient samples and should not be relied on to rule out patient sample errors caused by room temperature Quality controls should be run within the temperature restrictions listed in the table on page 2 of this letter Quality controls should not be used in place of the narrowed operating temperature specifications and are not a substitute for ambient temperature monitoring While some controls may be affected to different degrees by changes in room temperature the Beckman Coulter AccuTnI Qu
16. were surveyed in the last year nearly a quarter of those 22 5 achieved perfect surveys To promote quality patient care we implemented a program designed specifically for waived labs to help ensure that personnel learn about and implement Good Laboratory Practices We launched COLAcentral to assist our laboratories with their compliance training and documentation management needs COLAcentral also helps us provide better customer service through alert messages and easy access to educational products Our newest endeavor www COLAinsider org highlights COLA achievements and staff members as well as interesting news from laboratory medicine to help us stay connected to you We ve improved our internal operations since January 2010 COLA has implemented a metrics system to measure and monitor internal processes and progress Our main goal is to streamline our processes to provide you with the best service possible We ve made strides in the educational arena also The symposium for Clinical Laboratories has continued to grow in number of attendees in variety of exhibitors and in diversity of educational session topics We strive to update you on as many themes as possible from regulatory changes to laboratory business operations to scientific advances Many of our online courses and down loadable products hav
17. 0 patient results and 600 quality control results designation of quality control levels tagging of test results with date and time entry of Patient ID and or Operator ID or Operator PIn and printing of results HeMOCHROn Configuration Manager software which is included with the system allows the user to connect a personal computer to the instrument and perform system configuration functions using the fast and convenient Microsoft Windows user interface HeMOCHROn ReportMaker software available separately allows the user to connect a personal computer to an instrument and perform various data management and data reporting functions PROTIMe The ITC ProTime Microcoagulation system is a portable AC or battery operated PT InR testing instrument designed to allow healthcare professionals and or patients to safely monitor the clotting activity of patients on oral anticoagulant therapy The test procedure is simple and safe and performance is comparable to laboratory testing The system utilizes a disposable self contained micro volume reaction cell cuvette and a drop of whole blood from a fingerstick or anticoagulant free venous blood sample The ProTime system consists of the ProTime instrument the reagent cuvette with built in quality control QC and the Tenderlett Plus sample collection system The instrument and cuvette QC function together to ensure correc
18. C O L A s M A Y J u n e 1 1 insights IMPORTANT RECALL INFORMATION Starting on Page 14 Into Coagulation AL So In tHIS ISSUE Letter from the Chair 2 Coagulation 3 significance of the International normalized Ratio InR 4 Comparison of Point of Care Coagulation systems 5 Advertisements 7 amp 10 urgent Medical Device Correction update Recall notices 14 COLA Technical Bulletins 24 COLA s insights MAY June 11 2 From tHE CHAIr Bittersweet That is the best way to describe this moment the end of my term as Chair of COLA s Board of Directors Much like a high school or college graduate I have a sadness that this period in my life is ending Also like the graduate I can look back over the last two years with pride in the organization s accomplishments COLA has maintained its status as the largest accrediting agency granted deemed status by CMs Of the 7600 labs that COLA accredits approximately 3600
19. COAGuCHeK xs PLus sYsTeM The CoaguChek xs Plus system quantitatively measures prothrombin time PT InR for patients who are taking oral anticoagulation medications using fingerstick capillary or non anticoagulated venous whole blood since a low InR can increase the risk of blood clots and a high InR can increase the risk for internal bleeding the patient s physician determines the best InR range for that patient The therapeutic range varies and is dependent upon several factors including why the patient is taking anticoagulants and how the patient reacts to them The CoaguChek xs Plus system consists of a meter and PT test strips Optional liquid CoaguChek xs Plus PT Controls are also available The CoaguChek xs Plus system also includes data management functions featuring security elements such as QC lockout for use with the optional liquid quality controls The meter provides a step by step testing guide using symbols and instructions on the display each box of test strips has its own code chip that contains important lot specific information about the test strips including expiration date and calibration data The meter and test strips work together to provide a safe and reliable system for testing clotting time With the code chip inserted in the meter simply insert a test strip and apply a blood sample The meter displays the result in about
20. DInG BRuIse CLOT FORMATIOn COMMOn PATHWAY COuMADIn exTRInsIC FACTOR FIBRInOGen HeMATOMA InR InTRInsIC IsI LIVeR PLAsMA PLATeLeTs POInT OF CARe PORTABLe PROTHROMBIn seRuM THROMBOPLAsTIn VITAMIn K WARFARIn WHOLe BLOOD
21. I am leaving COLA in the very capable hands of Dr James stackhouse who becomes Chair in July 2011 He can certainly relate to the majority of our clients as he is certified in Internal Medicine and maintains a private practice in north Carolina He has also volunteered with numerous medical professional and governmental bodies and has served them in many capacities Additionally he is a Clinical Assistant Professor in the Department of Medicine at the university of north Carolina school of Medicine This final fact ensures COLA s emphasis on education will be maintained since he holds education in such high regard Verlin K Janzen MD FAAFP Chair COLA Board of Directors COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 3 Coagulation THe COMPLex PROCess BY WHICH BLOOD FORMs CLOTs Did you know that every time you bang your hand on a stair rail or twist your ankle your body starts forming blood clots at the injury site Our bodies form blood clots all the time through a process known as hemostasis even when we do not remember the hit or bump so why aren t we one big clot Because of the remarkable biological feedback systems in our bodies In addition to the coagulation promoting factors there are also substances in blood which inhibit coagulation Whether or not blood coagulates depends on the balance that ex
22. a uniCel DxI Immunoassay system All remaining Access assays may run unrestricted on a uniCel DxI Immunoassay system in a temperature range of 18 C to 30 C 64 4 F to 86 0 F unless stated otherwise in the assays instructions for use You should ensure that your laboratory has established a procedure to monitor and review room temperature during system operation As an example the College of American Pathologists Laboratory Accreditation Inspection Checklist requires laboratories to document adequate control of room temperature to ensure optimal performance of electronic instruments Gen 61300 Review your historical room temperature records to determine if your uniCel DxI Immunoassay system was operated outside the revised temperature specifications for the Access assays identified on page 2 Based on this review your laboratory director may determine that a review of historical quality control performance and patient results is warranted If your laboratory is unable to maintain these temperature ranges do not report results out of the laboratory and please contact our Customer support Center for additional suggestions Via website http www beckmancoulter com customersupport support Via phone 1 800 854 3633 Review the attached Question and Answer document share this information with your laboratory staff and retain this notification as part of your laboratory Quali
23. air dry for at least 15 minutes before re attaching the test strip guide cover and start testing again Please contact Roche Diagnostics Point of Care Technical service at 1 800 820 0995 if you have any questions about the cleaning disinfecting solutions detailed in this uMDC update usEFuL TIPs Useful tips on how to minimize the risk of contaminating the meter with blood Apply blood via side dosing directly from the fingertip If pipettes or syringes are used the blood volume should not exceed 10 L CLEANINg VERIFICATION The CoaguChek xs system and the CoaguChek xs Plus system are equipped with a two level on board quality control test To verify the meter after cleaning an additional system check can be performed with a single level of optional external control CoaguChek xs PT Control for the CoaguChek xs system or CoaguChek xs Plus PT Controls for the CoaguChek xs Plus system A limited supply of the CoaguChek xs PT Control will be available in the first quarter Q1 of 2010 Contact your Roche Diagnostics sales representative for information on availability METER MODIFICATIONs Roche Diagnostics is adding safeguards to the meter to prevent the potential for cleaning related malfunctions Meters equipped with the following modifications will be available beginning the first quarter Q1 of 2010 new firmware that provides an additional fail safe for cleaning
24. ality Control ReF 33349 does not detect a shift in results due to temperature changes because it uses the same temperature insensitive recombinant material used in calibration materials note This QC material ReF 33349 has been discontinued by Beckman Coulter Beckman Coulter included the following control products during internal testing The specific lots tested responded to changes in room temperature in a similar manner as patient samples The performance of other lots was not evaluated Product Name Part Number Lot Number Bio Rad Cardiac Markers Plus 180 29740 MAs CardioImmune CAI xL4 CxL13014 MORe Diagnostics Cardiac Markers 150 91100 Bio Rad Liquichek Immunoassay Plus 360 40750 4 How did you determine the narrower operating temperature specifications All assays were tested on multiple platforms at several temperature points in a temperature controlled environment The effect of room temperature on measurement performance was assessed This testing allowed us to identify the magnitude of the error for each 1 C 1 8 F temperature change The temperature restrictions were selected in order to minimize the sample error while still allowing laboratories to run these assays on the Access Immunoassay systems 5 Where should I monitor room temperature in my laboratory How frequently Room temperature should be monitored where
25. are solutions such solutions will compensate for changes in assay performance related to changes in room temperature 8 What if my laboratory cannot maintain the revised temperature ranges If your laboratory is unable to maintain these temperature ranges do not report results out of the laboratory Please contact our Customer support Center for additional suggestions and to report ongoing problems Via website http www beckmancoulter com customersupport support Via phone 1 800 854 3633 Access Immunoassay Systems include Access Access 2 SYNCHRON LXi 725 and UniCel DxC 600i Available exclusively from Alere or its authorized distributors for use in Beckman Coulter Immunoassay Systems Alere and Triage are trademarks of the Alere group of companies Bio Rad and the Bio Rad logo are trademarks of Bio Rad Laboratories Inc MAS and Cardioimmune are trademarks of Medical Analysis Systems Inc Beckman Coulter the Beckman Coulter logo Access UniCel Synchron LX and AccuTnI are trademarks of Beckman Coulter Inc and are registered in the USPTO COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 21 gt gt CONTINuED ON PAgE 22 Urgent Field Safety notice Product Correction unICeL DxI IMMunOAssAY sYsTeMs ATTENTION uNICEL DXI IMMuNOAssAy CusTOMER This letter contains important information that requires your im
26. ated in the assays instructions for use You should ensure that your laboratory has established a procedure to monitor and review room temperature during system operation As an example the College of American Pathologists Laboratory Accreditation Inspection Checklist requires laboratories to document adequate control of room temperature to ensure optimal performance of electronic instruments Gen 61300 Review your historical room temperature records to determine if your Access Immunoassay system was operated outside the revised temperature specifications while testing Access AccuTnI Access Cortisol or Triage BnP Based on this review your laboratory director may determine that a review of historical quality control performance and patient results is warranted If your laboratory is unable to maintain these temperature ranges do not report results out of the laboratory and please contact our Customer support Center for additional suggestions Via website http www beckmancoulter com customersupport support Via phone 1 800 854 3633 Review the attached Question and Answer document share this information with your laboratory staff and retain this notification as part of your laboratory Quality system documentation If you have forwarded any of the affected products listed above to another laboratory please provide a copy of the letter to them Complete and return the enclos
27. ay systems 4 Where should I monitor room temperature in my laboratory How frequently Room temperature should be monitored where your uniCel DxI Immunoassay system is located Monitoring should be performed frequently enough to ensure that the room temperature does not exceed the revised temperature requirements during the time the affected assays are being performed In addition good clinical laboratory practice calls for daily monitoring and review of room temperature while looking for large fluctuations Resources from laboratory accrediting agencies provide good guidance Your building engineering or maintenance staff can help to ensure a proper room temperature monitoring procedure is in place and make recommendations to your laboratory director to determine the monitoring frequency 5 Will the uniCel DxI system alert the operator if the room temperature exceeds 4 C 7 2 F from the original calibration for assays identified on page 2 no the uniCel DxI system currently in your laboratory will not alert the operator if the room temperature exceeds 4 C 7 2 F from the original calibration for assays identified in the table on page 2 until a permanent solution is implemented you may wish to schedule routine calibrations when your laboratory is near its average room temperature This may minimize the need for your laboratory to monitor multiple assays for recal
28. coagulation cascade leading to the formation of a blood clot This cascade is comprised of three pathways extrinsic intrinsic and common Two laboratory tests are commonly used to evaluate coagulation disorders Prothrombin Time PT INR which measures the integrity of the extrinsic system as well as factors common to both systems and Activated Partial Thromboplastin Time aPTT which measures the integrity of the intrinsic system and the common components COVeR sTORY COLA s insights MAY June 11 4 Significance of the International normalized ratio Inr VARIABLes AFFeCTInG BLOOD COAGuLATIOn As stated in the cover article blood coagulation is affected by many different variables These occur within the extrinsic intrinsic and or common pathways of the coagulation cascade or they can be external to the cascade When performing laboratory testing to assess the coagulation process there are even more variables to consider Prothrombin Time PT is a lab test that measures the time it takes for a clot to form therefore the result is reported in seconds PT evaluates the extrinsic and common pathways of the coagulation cascade including the following coagulation factors fibrinogen factor I prothrombin factor II factor V factor VII and factor Ix If any of these factors is deficient and or functioning abnormally the PT will be prolonged This test is also used to monitor and adjust the
29. company has notified the u s Food and Drug Administration FDA and has issued recall communications to all physicians2 and other customers3 involved Any adverse reactions may also be reported to the FDA s MedWatch Program by fax at 1 800 FDA 0178 by mail at MedWatch HF 2 FDA 5600 Fishers Lane Rockville MD 20852 9787 or on the MedWatch website at www fda gov Healthcare professionals and customers may call the following for assistance if they have further questions about the recall Recall Logistics stericycle 1 877 546 0128 General Inquiries Bristol Myers squibb Customer Relations 1 800 332 2056 option 1 then option 4 Medical Inquiries Bristol Myers squibb Medical Information 1 800 321 1335 option 5 Recall Reimbursement Bristol Myers squibb Process Customer service Operations 1 800 631 5244 option 1 then option 5 ResOuRCes 1 Insights is publishing this recall notice since the lot numbers are still within date and product may still be in consumers hands To view the original recall letter please click here http www fda gov safety Recalls ArchiveRecalls 2010 ucm218864 htm 2 For more information and to view the communication addressed to physicians please click here http www bms com documents news features sAMPLe_Coumadin1mg_recall_letter pdf 3 For more information and to view the communication addressed to consumers please
30. consistent evaluation of results from different laboratories which allows the patient to travel and still obtain comparable test results The InR was established in the early 1980s by the International Committee on Thrombosis and Hemostasis ICTH and the World Health Organization WHO It is not a new laboratory test it is a mathematical calculation to account for the variability of the PT reagent INR PT PaTIeNT PT NoRmal ISI The PT patient is the PT result of the patient reported in seconds The PT normal is determined by the laboratory utilizing their particular reagent instrument combination It is the mean reported in seconds of a 20 30 patient normal study This normal study is performed whenever the reagent lot and or the instrument changes The IsI is determined by the thromboplastin manufacturer and varies with each lot of reagent The reagent lot is compared to a calibrated internationally accepted standard reference preparation of thromboplastin which has an IsI value of 1 0 By definition the more sensitive reagent lots have an IsI of less than 1 0 and the less sensitive lots have an IsI value greater than 1 0 gt gt CONTINuED ON PAgE 10 The IsI value is critical in the calculation of the INR since it is the exponent in the formula which means t
31. ctor IV V proaccelerin labile factor Co factor of x with which it forms the prothrombinase complex VI unassigned old name of Factor Va VII stable factor proconvertin Activates Ix x VIII Antihemophilic factor A Co factor of Ix with which it forms the tenase complex Ix Antihemophilic factor B or Christmas factor Activates x forms tenase complex with factor VIII x stuart Prower factor Activates II forms prothrombinase complex with factor V xI plasma thromboplastin antecedent Activates Ix xII Hageman factor Activates factor xI VII and prekallikrein xIII fibrin stabilizing factor Crosslinks fibrin von Willebrand factor Binds to VIII mediates platelet adhesion prekallikrein Fletcher factor Activates xII and prekallikrein cleaves HMWK high molecular weight kininogen HMWK Fitzgerald factor supports reciprocal activation of xII xI and prekallikrein fibronectin Mediates cell adhesion gt gt CONTINuED ON PAgE 7 PROTHROMBIn TIMe TesT PT InR The prothrombin time PT test is used to help diagnose clotting disorders and to monitor patients taking certain medications specifically it evaluates the presence of factors VII V and x prothrombin and fibrinogen A prothrombin time within the 11 15 second range depending on the source of thromboplastin reagent used indicates that the patient has normal amounts of the above clotting fa
32. ctors A prolonged PT indicates a deficiency of any of the above factors VII x V prothrombin or fibrinogen It may also mean that the patient has a vitamin K deficiency Vitamin K is a co factor in the synthesis of factors II prothrombin VII Ix and x or a liver disease The liver is the site of synthesis of most of the plasma protein factors The prothrombin time of patients receiving a vitamin K competing drug such as warfarin used in anticoagulation therapy will also be prolonged usually in the range of 1 to 2 times the normal PT time COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 7 Call Orchard for a demonstration Harvest the power of an Orchard LIS Produce more with less Produce more with less 800 856 1948 www orchardsoft com 2011 Orchard Software Corporation Robust rules based decision making tools in Orchard Harvest LIS reduce errors and make routine decisions and tasks automatic Orchard s diagnosis code screening will greatly improve first pass reimbursements And systems integration helps you meet Meaningful Use criteria and eliminates manual entry errors as demographics orders results and billing data flow auto matically between your host system billing EMR and reference lab Get lab results into your EMR and meet Meaningful Use criteria Increase reimbursement with ICD 9 screen
33. d from the surfaces of damaged cells outside the circulatory system the intrinsic pathway is so named because all the activators of the pathway are within or intrinsic to blood Therefore outside tissue damage is not needed to initiate the cascade In vivo when the endothelial cells lining the blood vessel are damaged blood comes into contact with collagen fibers underneath the cells and the intrinsic pathway begins normal PTT times require the presence of the following coagulation factors I II V VIII Ix x xI amp xII See Figure 2 2 Figure 2 In vivo when the endothelial cells lining the blood vessel are damaged blood comes into contact with collagen fibers underneath the cells Contact with collagen fibers activates clotting Factor XII which activates Factor X When Factor X is activated it combines with Factor V to make the active form of the enzyme prothrombinase thus completing the intrinsic pathway Prolonged PTT tests may be due to Inherited factor deficiencies Prolonged PTTs due to a factor deficiency usually correct after being mixed with pooled normal plasma The PTT may be prolonged in von Willebrand disease the most common inherited bleeding disorder in which the decreased von Willebrand factor affects platelet function Hemophilia A and Hemophilia B Christmas disease are two other inherited bleeding disorders resulting from a
34. decrease in factors VIII and Ix respectively Acquired factor deficiencies An example of an acquired deficiency is one due to lack of vitamin K Vitamin K found in various leafy green vegetables and produced by certain gastrointestinal bacteria is a key component to proper blood coagulation Vitamin K deficiencies are rare but can occur due to an extremely poor diet malabsorption disorders or prolonged use of certain antibiotics Most coagulation factors including the vitamin K dependent ones are manufactured by the liver thus liver disease may also prolong the PT and PTT However with both liver disease and vitamin K deficiency PT is more likely to be prolonged than PTT A nonspecific inhibitor nonspecific inhibitors such as the lupus anticoagulant LA bind to chemicals called phospholipids which are found on the surface of platelets since phospholipids assist in the clotting process and since the PTT test reagents contain phospholipids such antibodies may prolong the PTT This is suggestive of a bleeding problem when in fact the presence of these inhibitors is usually associated with thrombosis A specific inhibitor Although relatively rare these are antibodies that specifically target certain coagulation factors such as Factor VIII antibodies They may develop in someone with a bleeding disorder who is receiving factor replacements suc
35. e been reviewed and revised to keep you up to date on the latest information in laboratory medicine We ve created educational webinars that address specific issues seen during laboratory surveys Our new Compliance Tips and Technical Bulletins were prepared with you in mind As the title suggests the Compliance Tips provide you with helpful hints to maintain regulatory compliance The Technical Bulletins address changes in criteria testing method alerts and other technical issues that you will find useful and informative even Insights has undergone changes The most noticeable change is the switch to the electronic format Without restrictions imposed by printing and mailing costs we can jam pack every issue with information valuable to your laboratory Perhaps our most notable accomplishment is our recently obtained certification under IsO standard 9001 2008 which makes COLA the only accreditation organization deemed by CMs to achieve this status By obtaining certification through the International Organization for standardization IsO COLA demonstrates our willingness to walk the walk by subjecting ourselves to the same kind of third party review our surveyors perform for you our customers Through this structured process you can assure your patients that COLA as well as our laboratories meet standards rigorously tested by a third party I am heartened by the fact that
36. ed response form within ten days We apologize for the inconvenience that this issue has caused your laboratory Thank you for your continued support of Beckman Coulter products sincerely scott Cundy Vice President Quality and Regulatory Affairs Immunoassay and Molecular Business Center QuEsTIONs AND ANsWERs 1 What is the effect of temperature change on AccuTnI results Beckman Coulter s internal testing showed that AccuTnI results are inversely proportional to temperature AccuTnI results will decrease by approximately 3 5 for every 1 C increase in room temperature and results will increase with a decrease in room temperature The following chart illustrates expected results if a patient sample were tested at five different room temperatures 18 C 64 4 F 0 61 ng mL 21 C 69 8 F 0 56 ng mL 24 5 C 76 1 F 0 50 ng mL 28 C 82 4 F 0 44 ng mL 32 C 89 6 F 0 37 ng mL 2 Can I recalibrate an assay to correct for large temperature changes more than 4 C 7 2 F For Access AccuTnI recalibration does not correct for the temperature induced shift of reported results This is due to the fact that AccuTnI calibrators use a recombinant antigen that is not sensitive to temperature changes in the same manner as patient samples For Access Cortisol and Triage BnP changes in reported results due to a change in the room
37. er Note These updated cleaning procedures replace the current procedures in your CoaguChek Xs or CoaguChek Xs Plus user manuals Warning Do not use sprays of any sort Warning Ensure that the swab or cloth is only damp not wet Meter Housing Outside of Meter 70 isopropyl alcohol 10 bleach Meter Test strip guide Measurement Chamber Remove the test strip guide cover before cleaning 91 or 99 isopropyl alcohol Discontinue 70 isopropyl alcohol or 10 bleach solution gt gt CONTINuED ON PAgE 15 COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 15 COnTInueD FROM PAGe 14 COAguCHEk Xs AND COAguCHEk Xs PLus METERs CLEANINg DIsINFECTINg THE METER HOusINg use only the following items for cleaning disinfecting the CoaguChek xs or CoaguChek xs Plus meter housing for a contact time of gt 1 minute 70 isopropyl alcohol 10 sodium hypochlorite 1 part bleach to 9 parts de ionized water made fresh every 24 hours NOTE Do not use any other disinfectants cleaning solutions on the meter housing Discontinue use of 91 alcohol on the meter housing ensure that the blue meter test strip guide cover remains tightly closed while cleaning the housing Wipe the meter housing thoroughly while avoiding the meter test strip guide measurement chamber Let the disinfecta
38. es 98200 Triage BnP Test for Beckman Coulter Immunoassay systems 4 C 7 2 F 17 Decreases 386371 Access CK MB 4 C 7 2 F 5 Increases A12985 Access TPO Antibody 4 C 7 2 F 11 Increases A13422 Access Free T3 4 C 7 2 F 13 Increases A16972 Access Intraoperative PTH Test ID 215 4 C 7 2 F 17 Increases A31588 Access Toxo IgG 5 C 9 0 F 11 Increases A36097 Access Inhibin A 4 C 7 2 F 8 Decreases A48617 Access sHBG 4 C 7 2 F 16 Increases Toxo IgG IFU is already labeled for this temperature range restriction UniCel DxI Immunoassay Systems include DxI 800 DxI 600 DxC 880i DxC 860i DxC 680i and DxC 660i TM COLA s insights MAY June 11 22 COnTInueD FROM PAGe 21 uRgENT FIELD sAFETy NOTICE PRODuCT CORRECTION IMPACT Inaccurate results may lead to misdiagnosis inappropriate testing inappropriate treatment and or delayed treatment of patients ACTION Beckman Coulter now requires a narrowed room temperature operating range of 18 C to 30 C 64 4 F to 86 0 F for all uniCel DxI Immunoassay systems during system operation In addition Access assays identified in the table above now require recalibration if the room temperature varies more than 4 C 7 2 F from the temperature at which assay calibration was established when used on
39. h as Factor VIII which is used to treat hemophilia A or spontaneously as an autoantibody Heparin Whether a contaminant of the sample or part of anticoagulation therapy heparin will prolong the PTT test For anticoagulant therapy the target PTT is often about 1 5 to 2 5 times longer than a person s pretreatment level Warfarin Coumadin anticoagulation therapy The PTT is not used to monitor warfarin therapy but it may be affected by it Typically the PT is used to monitor warfarin therapy Prolonged PTT levels may also be seen with leukemia excessive bleeding in pregnant women prior to or after giving birth or recurrent miscarriages COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 9 COnTInueD FROM PAGe 8 COAguLATION PT AnD aPTT TOGeTHeR Both the PT and aPTT tests are used to investigate unexplained bleeding or clot formation They may be ordered in tandem to evaluate hemostasis the process that the body uses to form blood clots to help stop bleeding Other tests such as bleeding time and platelet counts may also be helpful The PTT evaluates the coagulation factors xII xI Ix VIII x V II prothrombin and I fibrinogen as well as prekallikrein PK and high molecular weight kininogen HMWK The PT test eva
40. hat even small errors in assigning the IsI value can result in substantial errors in the INR calculation COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 5 Comparison of Point of Care Coagulation Systems THIs ARTICLe COnsIsTs OF InFORMATIOn AVAILABLe On THe ITC1 amp ROCHe DIAGnOsTICs2 WeBsITes several different point of care coagulation testing devices are currently available They range from waived meters available for home use to non waived instruments that perform multiple coagulation tests Attributes of six different systems are featured here HeMOCHROn sIGnATuRe PLus The ITC Hemochron signature Plus Microcoagulation system offers point of care monitoring with numerous features to meet the needs of each individual department as well as the needs of regulatory compliance It is a small battery operated hand held instrument that performs individual point of care coagulation tests on fresh or citrated whole blood These tests include Activated Clotting Time ACT and ACT LR Activated Partial Thromboplastin Time aPTT and aPTT Citrate and Prothrombin Time PT InR and PT InR Citrate The system is intended to be used only with test cuvettes that are available from ITC Data management capabilities of the instrument include storage of up to 400 patient results and 400 quality control results designation of quality control levels tagging
41. he uniCel DxI Immunoassay systems The restricted room temperature ranges will not completely eliminate the temperature based error but will limit the size of the error Beckman Coulter is currently working on a more permanent solution to eliminate the error completely The restricted temperature ranges and the estimated maximum error that will be seen as the room temperature varies across these ranges are shown in the table below These assays should be recalibrated if the room temperature changes by more than 4 C 7 2 F from the room temperature at which the assay calibration was established Part Product Restricted Dose change If temperature temp range over restricted range increases assay result 33000 Access Vitamin B12 4 C 7 2 F 8 Increases 33211 Access AFP 4 C 7 2 F 10 Increases 33410 Access ultrasensitive Insulin 4 C 7 2 F 6 Increases 33540 Access estradiol 4 C 7 2 F 11 Decreases 33560 Access Testosterone 4 C 7 2 F 8 Decreases 33580 Access ultrasensitive hGH 4 C 7 2 F 7 Increases 33600 Access Cortisol 4 C 7 2 F 6 Decreases 33820 Access Fast TsH Test ID 246 4 C 7 2 F 7 Increases 33880 Access Free T4 4 C 7 2 F 8 Increases 34430 Access Rubella IgG 4 C 7 2 F 11 Increas
42. ibration at different temperature points 6 What solutions is Beckman Coulter working on to address this issue Beckman Coulter is currently investigating both hardware and software solutions such solutions will compensate for changes in assay performance related to changes in room temperature 7 What if my laboratory has always operated within the narrowed temperature range The Access assays affected by this recall generate erroneous results as listed in the table on page 2 of this notice The new recommended temperature requirements are intended to minimize the effects caused by changes in room temperature but they do not completely eliminate the error If your laboratory has always operated within the revised temperature requirements then the range of the errors should be limited to those described in the summary table on page 2 8 What if my laboratory cannot maintain the revised temperature ranges If your laboratory is unable to maintain these temperature ranges do not report results out of the laboratory Please contact our Customer support Center for additional suggestions and to report ongoing problems Via website http www beckmancoulter com customersupport support Via phone 1 800 854 3633 UniCel DxI Immunoassay Systems include DxI 800 DxI 600 DxC 880i DxC 860i DxC 680i and DxC 660i Available exclusively from Alere or its authorized distributors for use in Beckman Coulter Immunoassay Sys
43. ice Bristol Myers squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately The company has notified the u s Food and Drug Administration FDA and will issue recall communications to all physicians and other customers involved Any adverse reactions may be reported to the FDA s MedWatch Program by fax at 1 800 FDA 0178 by mail at MedWatch HF 2 FDA 5600 Fishers Lane Rockville MD 20852 9787 or on the MedWatch website at www fda gov Health care professionals and customers may call the following for assistance if they have further questions about the recall For information related to this recall stericycle Inc 1 866 918 8739 1 To view the original press release please click here http www fda gov safety Recalls ucm253523 htm COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 17 Bristol myers Squibb Initiates a nationwide Voluntary recall of Coumadin 1 mg tablet Blister Packs ReCALL InVOLVes 1 MG PHYsICIAn sAMPLe BLIsTeR PACKs AnD 1 MG HOsPITAL BLIsTeR PACKs OnLY 1FOR IMMeDIATe ReLeAse July 12 2010 Bristol Myers squibb initiates a voluntary recall of 3 lots of physician sample blister packs of Coumadin 1 mg tablets and 5 lots of Coumadin 1 mg tablet hospital unit dose HuD blister packs The following lot numbers are
44. iguration Manager software show pass fail for Liquid Quality reagent of IsI 1 0 Control LQC and stores actual Off meter sampling values provides safety against Allows up to 600 OID table entries disease transmission Manually enter up to 9 numeric Barcoded cuvette characters for PIn no coding necessary Automatic tagging of test results Longer open pouch with date and time stability up to 16 hours scan or manually enter up to 20 Available for patient PID alphanumeric characters self testing scan or manually enter up to 16 OID alphanumeric characters Instrument automatically measures amp moves required sample volume to the cuvette test channel and discards excess blood in the cuvette waste channel EQC Electronic Quality Control LQC Liquid Quality Control materials external controls PIN Patient Identification Number OID Operator Identification PID Patient Identification gt gt CONTINuED ON PAgE 13 COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 13 COnTInueD FROM PAGe 12 COMPARIsON OF POINT OF CARE COAguLATION sysTEMs COMPANy ROCHE DIAgNOsTICs Instrument CoaguChek s CoaguChek Xs CoaguChek Xs Plus sample Whole blood capillary or venous Whole blood capillary or venous Whole blood capillary or veno
45. ing Reduce errors and save time with rules based technology Extensive quality control features simplify QC COnTInueD FROM PAGe 6 COAguLATION The result for a prothrombin time performed on a normal individual will vary according to the type of test system employed methods can be optical or mechanical This is due to the variations between different batches lots of manufacturer s tissue factor in the reagent thromboplastin used to perform the test To lessen the impact of these variations the InR International normalized Ratio is used It is a way of standardizing the results of prothrombin time tests no matter the testing method Therefore a PT test is sometimes referred to as an InR test By comparing InR results clinicians can confidently evaluate the patient s status even when results come from different laboratories employing different test methods using the InR system treatment with blood thinning medicine anticoagulant therapy will be consistent The InR was introduced in the early 1980s and became widely accepted worldwide especially after endorsement by the World Health Organization The InR is a mathematical calculation devised to standardize PT results each manufacturer assigns an International sensitivity Index IsI value for any tissue factor they manufacture The IsI value which is usually between 1 0 and 2 0 indicates how a partic
46. ing to two different cascading pathways the intrinsic initiated by contact with an abnormal foreign surface or the extrinsic initiated by exposure to tissue factors Please keep in mind The two pathways converge so the final steps the common pathway are common to both schemes Clotting can be initiated via either pathway the more rapid 15 20 secs extrinsic scheme or the slower 2 6 mins intrinsic scheme The division into two pathways is only an artifact of in vitro testing the two pathways interconnect at several levels In vivo both pathways must be activated for effective hemostasis Both coagulation pathways by a series of feedback mechanisms control their own activity e g traces of thrombin enhance the activity of earlier factors in the scheme Figure 1 Thrombin is the master regulator of the coagulation cascade It converts fibrinogen to fibrin in order to form a loose fibrin clot Thrombin also activates Factor XIII or transglutaminase to form stabilizing covalent bonds within the fibrin strands to activate more platelets and form a stronger clot Finally thrombin activates Factors V and VIII in a positive feedback mechanism so the clotting cascade is self regulating and knows when to turn off gt gt CONTINuED ON PAgE 6 When body tissue is injured and begins to bleed it initiates a sequence of clotting factor activities the
47. ists between the two groups of factors pro coagulants and anti coagulants When a body tissue is injured and begins to bleed it initiates a sequence of clotting factor activities the coagulation cascade leading to the formation of a blood clot This cascade is comprised of three pathways extrinsic intrinsic and common Two laboratory tests are commonly used to evaluate coagulation disorders Prothrombin Time International normalized Ratio PT InR which measures the integrity of the extrinsic system as well as factors common to both systems and Activated Partial Thromboplastin Time aPTT which measures the integrity of the intrinsic system and the common components BLOOD CLOT FORMATIOn Clot formation is a function of plasma It depends upon the orderly interaction of a group of plasma proteins which are sequentially activated following vascular injury with phospholipids from either damaged tissue or platelets and calcium ions Ca The final stages include the formation of thrombin which then converts soluble plasma protein fibrinogen to insoluble fibrin Another factor converts the fibrin into a cross linked polymer which stabilizes the platelet plug and traps red blood cells RBCs in the meshwork to form the actual blood clot See Figure 11 Depending on the type of vascular damage or abnormality clot formation can be initiated and proceed accord
48. itamin K is needed to make prothrombin and other clotting factors Check how well the liver is working Prothrombin times are checked along with other liver tests such as aspartate aminotransferase AsT or sGOT and alanine aminotransferase ALT or sGPT Check to see if the body is using up its clotting factors so quickly that the blood cannot clot leading to excessive bleeding This may mean the person has disseminated intravascular coagulation DIC gt gt CONTINuED ON PAgE 8 COLA s insights MAY June 11 8 gt gt CONTINuED ON PAgE 9 COnTInueD FROM PAGe 7 COAguLATION ACTIVATeD PARTIAL THROMBOPLAsTIn TIMe TesT APTT OR PTT The activated partial thromboplastin time aPTT is a test performed to investigate bleeding disorders and to monitor patients taking an anticoagulant such as heparin which inhibits factor x and thrombin while it activates anti thrombin But wait isn t that sort of the same as the PT InR Well we are still discussing coagulation and the three pathways intrinsic extrinsic and common that make up the coagulation cascade so yes there most definitely are similarities As stated earlier the PT InR evaluates the extrinsic and common pathways Complementary to this the PTT measures the integrity of the intrinsic system and the common components While the extrinsic pathway requires tissue factor TF release
49. luates the coagulation factors VII x V II and I fibrinogen By evaluating the results of the two tests together a clinician can gain clues as to what bleeding or clotting disorder may be present The following chart demonstrates how coagulation disorders or diseases affect various test results Please note that this list is merely representative and is not inclusive of every clotting illness or disease that may exist n Condition Prothrombin Time Partial Thromboplastin Time Bleeding Time Platelet Count Vitamin K deficiency or warfarin treatment prolonged prolonged unaffected unaffected DIC Disseminated Intravascular Coagulation prolonged prolonged prolonged decreased Von Willebrand disease unaffected prolonged prolonged unaffected Hemophilia unaffected prolonged unaffected unaffected Aspirin unaffected unaffected prolonged unaffected Thrombocytopenia unaffected unaffected prolonged decreased early liver failure prolonged unaffected unaffected unaffected end stage liver failure prolonged prolonged prolonged decreased uremia unaffected unaffected prolonged unaffected Congenital afibrinogenemia prolonged prolonged prolonged unaffected Factor V deficiency prolonged prolonged unaffected unaffected Factor x deficiency as seen in amyloid purpura prolonged prolonged unaffected unaffected Glanzmann s thromba
50. mediate attention regarding updated room temperature operating requirements for your uniCel DxI Immunoassay systems which can impact assay performance PRODuCT RIsk Certain Access immunoassays can produce inaccurate results when performed within the published uniCel DxI Immunoassay systems room temperature operating specification of 18 C to 32 C 64 4 F to 89 6 F Beckman Coulter has concluded that an increase in room temperature causes assay results for some assays to decrease while results for other assays increase with an increase in room temperature The magnitude of the temperature induced error varies between assays and can be as high as 4 25 for every 1 C 1 8 F change in room temperature for Intraoperative PTH and Triage BNP Test for Beckman Coulter Immunoassay systems and as low as 1 25 for every 1 C 1 8 F change in Ck MB The errors are caused when the room temperature changes from the room temperature at which the assays were calibrated When the room temperature changes recalibrating these assays limits the magnitude of the error on sample results Quality controls may not detect these errors and cannot be relied upon to ensure that your device is not generating erroneous results due to changes in the ambient room temperature In order to limit the size of the error Beckman Coulter is restricting the room temperature requirements for running the affected assays on t
51. nt cleaning solution sit on the meter for at least one minute Make sure that no liquid enters the meter or accumulates near any opening Wipe away residual moisture and fluids after cleaning the housing Allow wiped areas to dry for at least 15 minutes before performing a test CLEANINg THE METER TEsT sTRIP guIDE MEAsuREMENT CHAMBER Note Discontinue use of 70 isopropyl alcohol or 10 bleach solution including CoaguWipe Bleach Towels for cleaning disinfecting the meter test strip guide use only 91 isopropyl alcohol or 99 isopropyl alcohol to clean the CoaguChek Xs or CoaguChek Xs Plus test strip guide Do not use any other cleaning solutions on the test strip guide use of other cleaning solutions could result in damage to the meter Remove the test strip guide cover Hold the meter upright with the test strip guide facing down see picture below This will help prevent fluid from entering the meter There are different types of isopropyl alcohol Please note that only 91 isopropyl alcohol or 99 isopropyl alcohol can be used on the test strip guide Any other isopropyl alcohol cannot be used on the test strip guide without risk to the meter ensure the swab is only damp not wet Wipe the test strip guide area Let the cleaning solution sit for at least one minute Wipe away residual moisture and fluids Let the inside of the test strip guide
52. oassay systems 4 C 7 2 F 12 Decreases Access Immunoassay Systems include Access Access 2 SYNCHRON LXi 725 and DxC 600i gt gt CONTINuED ON PAgE 19 Safety notice COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 19 COnTInueD FROM PAGe 18 uRgENT FIELD sAFETy NOTICE PRODuCT CORRECTION IMPACT Inaccurate results may lead to misdiagnosis inappropriate testing inappropriate treatment and or delayed treatment of patients ACTION Beckman Coulter now requires a narrower room temperature operating range of 18 C to 30 C 64 4 F to 86 0 F for all Access Immunoassay systems during system operation In addition the following assays require further room temperature restrictions for all Access Immunoassay systems Access AccuTnI ReF 33340 and A78803 assay requires a system operating temperature range of 21 C to 28 C 69 8 F to 82 4 F Access Cortisol ReF 33600 requires recalibration if the room temperature varies more than 4 C 7 2 F from the temperature at assay calibration Triage BnP ReF 98200 requires recalibration if the room temperature varies more than 4 C 7 2 F from the temperature at assay calibration All other Access assays may run unrestricted on Access Immunoassay systems in a temperature range of 18 C to 30 C 64 4 F to 86 0 F unless otherwise st
53. on technology heparin and LMWH in a single test chamber saves time over conventional InR corrected for hematocrit within neutralizes therapeutic lab based testing specified range manage a broad levels of heparin and support for healthcare professionals array of patients with one device LMWH 24 hour toll free technical support easy and convenient to use InR corrected for hematocrit Reimbursement support including strip allows dosing from either top or within specified range toll free reimbursement hotline side for simple blood application streamlined data available to answer questions 18 month strip shelf life management no refrigeration needed Operator and QC Outside meter blood application lockout capabilities minimizes potential for cross Code chip programming contamination Data storage for up to small battery powered handheld 60 code chips meter for portability and efficiency easy and convenient to use efficient and cost effective Top or side strip dosing Auto on with strip insertion and with outside meter blood auto off capabilities application Testing treatment and potential new onboard controls revenue capture in one appointment no external QC necessary EQC Electronic Quality Control
54. proach to anticoagulation management focused at the point of care may increase the time patients are in range and reduce adverse events COAGuCHeK xs sYsTeM The next generation in point of care PT InR testing the CoaguChek xs system uses exclusive smart technology to help ensure accurate results and offers the flexibility and control that healthcare professionals need to confidently manage a wide range of anticoagulated patients This system offers healthcare professionals an easy and efficient way to obtain accurate PT InR results quickly at the point of care so they can make immediate therapy adjustments discuss them with the patient and document treatment decisions all in one appointment The CoaguChek xs system includes a small portable meter and individual patient test strips each box of test strips has its own code chip that contains important information about the strips including expiration date and lot number The meter and test strips work together to provide a safe and reliable system for determining clotting time The display on the meter guides you through the testing process With the code chip inserted in the meter simply insert a test strip and apply a blood sample The meter displays the result in about a minute The results are automatically stored in the meter s memory so they can be easily recalled
55. ransfer to PC software allow data transfer to PC allows data transfer to network and or printer network and or printer eMR LIs or web based InR management system CLIA Category non waived moderate complexity non waived moderate complexity Waived Other 1 Test menu PT InR aPTT ACT 1 Test menu PT InR aPTT ACT 1 PT InR only 2 Automatic calibration operator 2 Automatic calibration 2 self check performed calibration is not necessary operator calibration is prior to each test 3 Hct range of 20 55 not necessary operator calibration is 3 Hct range of 20 55 not necessary 3 Hct range of 20 60 4 Rechargeable battery Features Performs rapid and accurate tests Large easy to read display Accepts and stores patient within minutes Onboard ethernet connectivity port and or operator ID for Two level QC lockout Integrated barcode reader reduced transcription Preprogrammed valid operator scans and stores cuvette lot and errors IDs and notes QC information Auto sends results quickly Offers liquid and electronic LQC and eQC Lockout and easily to printer quality controls Configures via HeMOCHROn computer or LIs Customizable programming options Configuration Manager HCM to Thromboplastin with Conf
56. rature specifications and are not a substitute for ambient temperature monitoring Beckman Coulter included the following control products during internal testing The specific lots tested responded to changes in room temperature in a similar manner as patient samples The performance of other lots was not evaluated Product Name Part Number Lot Number Bio Rad Lyphochek Immunoassay Plus 370x 40240 Bio Rad Liquichek Immunoassay Plus 360 40750 Bio Rad Immunoassay specialty Control 359x 41630 Beckman Coulter Access Inhibin A QC A36100 011238 Beckman Coulter Access sHBG QC A48619 989455 MAs CardioImmune CAI xL4 CxL13014 gt gt CONTINuED ON PAgE 23 COLA Information Resource Center 800 981 9883 www cola org www Labuniversity org www COLAcentral com 23 COnTInueD FROM PAGe 22 uRgENT FIELD sAFETy NOTICE PRODuCT CORRECTION 3 How did you determine the revised operating temperature specifications All assays were tested on multiple platforms at several temperature points in a temperature controlled environment The effect of room temperature on measurement was assessed This testing allowed us to identify the magnitude of the error for each 1 C 1 8 F temperature change The temperature restrictions were selected in order to minimize the sample error while still allowing laboratories to run these assays on the uniCel DxI Immunoass
57. sthenia unaffected unaffected prolonged unaffected ResOuRCes 1 Johns Hopkins Medicine Division of Hematology educational materials Coagulation Cascade Human coagulation animation demonstration http www hopkinsmedicine org hematology Coagulation swf accessed May 2011 2 Ibid COLA s insights MAY June 11 10 COnTInueD FROM PAGe 4 sIgNIFICANCE OF THE INTERNATIONAL NORMALIzED RATIO INR InR TARGeT RAnGe Warfarin therapy is used to treat patients who are at risk of developing blood clots A clot can travel through the blood stream at which time it is called an embolus and lodge itself in smaller blood vessels blocking circulation end results of blockages include strokes TIA trans ischemic attacks or mini strokes and pulmonary emboli Any condition with an increased risk of blood clotting where the benefits of using oral anti coagulants outweigh the risks of treatment will require routine blood monitoring with PT InR These conditions include myocardial infarction MI or heart attack atrial fibrillation deep vein thrombosis DVT and some blood disorders Patients who have had surgery to replace damaged heart valves are also treated with anti coagulation therapy The risks associated with each patient s condition and the risks associated with anti coagulation therapy must be considered when determining the target range for the
58. t sample size collection technique test procedure device functionality and reagent integrity which helps ensure accurate results each time the test is performed Two types of cuvettes are available for use with the ProTime system One type has a three channel set up to run the integrated two level QC along with the patient test The second type has five micro channels to perform patient testing in triplicate in addition to the two levels of quality control gt gt CONTINuED ON PAgE 11 COLA s insights MAY June 11 6 COnTInueD FROM PAGe 3 COAguLATION In total we have 13 numbered protein clotting factors in addition to Prekallikrein and high molecular weight kininogen HMWK which don t have numbers associated with them All are necessary for effective coagulation All factors are made in the liver except for Factor VIII which is synthesized in endothelial cells Vitamin K is needed to make prothrombin and other clotting factors The following table describes each clotting factor along with its number if it has one and its function Coagulation Factors and Related substances Number and or Name Function I fibrinogen Forms clot fibrin II prothrombin Its active form IIa activates I V VII VIII xI xIII protein C platelets Tissue factor Co factor of VIIa formerly known as factor III Calcium Required for coagulation factors to bind to phospholipid formerly known as fa
59. tems Alere and Triage are trademarks of the Alere group of companies Bio Rad and the Bio Rad logo are trademarks of Bio Rad Laboratories Inc MAS and Cardioimmune are trademarks of Medical Analysis Systems Inc Beckman Coulter the Beckman Coulter logo Access UniCel and DxI are trademarks of Beckman Coulter Inc and are registered in the USPTO CoLA InSIgHtS COLA is sponsored by the American Academy of Family Physicians AAFP the American Medical Association AMA the American Osteopathic Association AOA and the American College of Physicians ACP and is endorsed by 29 national and state medical organizations Letters to the editor are welcome ADVeRTIsInG POLICY COLA accepts advertising requests for inclusion in it s publications All advertisements are subject to review and approval by COLA COLA reserves the right to reject or cancel any advertisement that is not in keeping with COLA s standards as a national accreditation organization and it s publication standards COLA and it s publications do not and will not endorse directly or indirectly any advertiser s products or services If you would like to discuss advertising opportunities please contact COLA at 410 381 6581 ext 3736 COLA 2011 COLA InsIGHTs is published periodically by COLA 9881 Broken Land Parkway suite 200 Columbia MD 21046 1195 COLA InFORMATIOn ResOuRCe CenTeR
60. treatment of patients who are receiving oral anticoagulant therapy i e patients who are taking blood thinners warfarin or Coumadin The activated Partial Thromboplastin Time aPTT also measures the time it takes for a clot to form and is also reported in seconds It differs from the PT test in that it evaluates the intrinsic and common coagulation pathways including the following factors xII xI Ix VIII x V II prothrombin and I fibrinogen Deficiencies and or functional abnormalities of all the major clotting factors can be detected when evaluating PT and aPTT results concurrently since many clotting factors are produced by the liver and require vitamin K to mature these tests will also be affected by liver disease damage and vitamin K deficiency esTABLIsHMenT OF THe InR The International normalized Ratio InR was established to minimize the effects of testing variables on PT results including Differences in reagents and instrumentation used by different laboratories Differences in reagents over time within the same laboratory Differences in reagent lots This assures clinicians that changes in PT results are due to changes in patient status rather than testing variables The InR has standardized PT results nationally and internationally by adjusting for changes in thromboplastin the reagent used in the PT test This allows a
61. ty system documentation If you have forwarded any of the affected products listed above to another laboratory please provide a copy of the letter to them Complete and return the enclosed response form within ten days We apologize for the inconvenience that this issue has caused your laboratory Thank you for your continued support of Beckman Coulter products sincerely scott Cundy Vice President Quality and Regulatory Affairs Immunoassay and Molecular Business Center QuEsTIONs AND ANsWERs 1 Can I recalibrate an assay identified on page 2 to correct for temperature changes of more than 4 C 7 2 F between original calibration and assay performance Yes If there is a temperature change of more than 4 C 7 2 F between calibration and assay performance you should recalibrate the assay before analyzing samples 2 Can I rely solely on my quality control results for the individual assays identified on page 2 to detect changes in assay performance due to temperature Certain quality control results may not be affected by room temperature change to the same degree as patient samples and should not be relied on to rule out patient sample errors caused by changes in room temperature Quality controls should be run within the temperature restrictions listed in the table on page 2 of this letter Quality controls should not be used in place of the narrowed operating tempe
62. ular batch of tissue factor compares to an internationally standardized sample The InR is the ratio of a patient s prothrombin time to a normal control sample raised to the power of the IsI value for the analytical system used since the calculation is logarithmic a very small error is magnified exponentially This fact makes the correct input of the manufacturer s ISI value critical for patient safety A high InR level such as InR 5 indicates that there is a high chance of bleeding whereas an InR 0 5 indicates a high chance of clot formation Generally speaking the normal InR range for a healthy person is 0 9 1 3 and 2 0 3 0 for patients on warfarin therapy The target InR may be higher in particular situations such as for those with a mechanical heart valve or bridging warfarin with a low molecular weight heparin Reasons to perform the PT and or the PT InR test include Check to see if blood thinning medicine such as warfarin Coumadin is working If the test is done for this purpose testing may be done every day at first The frequency of testing decreases as the correct medicine dosage is determined Check for a reason for abnormal bleeding or bruising Check for low levels of blood clotting factors The lack of some clotting factors can cause bleeding disorders such as hemophilia Check for a low level of vitamin K V
63. us sample Volume 10 l 8 l 8 l Analysis Time 1 minute 1 minute 1 minute Quality Control eQC cartridge LQC Integral QC and functional checks Integral functional checks no external QC required temperature verification test strips have integral 2 level QC optional LQC Data entry Display screen prompts Display screen prompts Touch screen Data storage 60 most recent results 100 most recent results 1000 patient amp 500 QC results Data sharing serial interface manual transcription Infrared interface manual transcription Data transfer to PC via infrared interface through optional base unit CLIA Category Waived Waived non waived moderate complexity Other 1 PT InR only 1 PT InR only 1 PT InR only 2 Hct range of 32 52 2 Hct range of 25 55 2 Hct range of 25 55 3 Reportable range InR 0 6 8 0 3 Reportable range InR 0 8 8 0 3 Reportable range InR 0 8 8 0 Features Greater patient satisfaction Accurate and flexible technology Accurate and flexible single visit test saves patient time Performs onboard QC and determines technology and money patient results in a single test chamber Performs onboard QC and simple efficient testing neutralizes therapeutic levels of determines patient results easy one butt
64. your Access Immunoassay system is located Monitoring should be performed frequently enough to ensure that the room temperature does not exceed the revised temperature requirements during the time the affected assays are being performed In addition good clinical laboratory practice calls for daily monitoring and review of room temperature while looking for large fluctuations Resources from laboratory accrediting agencies provide good guidance Your building engineering or maintenance staff can help to ensure a proper room temperature monitoring procedure is in place and make recommendations to your laboratory director to determine the monitoring frequency 6 What if my laboratory has always operated within the revised temperature requirements The Access assays affected by this recall generate erroneous results as listed in the table on page 2 of this notice The new recommended temperature requirements are intended to minimize the effects caused by changes in room temperature but they do not completely eliminate the error If your laboratory has always operated within the revised temperature requirements then the range of the errors should be limited to those described in the summary table on page 2 7 What solutions is Beckman Coulter working on to address this issue Beckman Coulter is currently investigating both hardware and softw

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