Sysmex® CS-2500 and CS-5100 System Coagulation Curve Errors Online Training

Welcome to the Sysmex® CS-2500 and CS-5100 System Coagulation Curve Errors Online Training course. This online training course includes: Understanding multi-wavelength detection Identifying normal clot progression How the instrument detects reaction errors The different reaction curve errors Corrective actions for the reaction curve errors Sysmex® is a trademark of Sysmex Corp. Navigate the software browser screen to view reaction curves Identify analysis data errors Identify the function of the multi-wavelength detection system Identify key areas of a normal reaction curve Upon successful completion of this course you will be able to: Identify proper corrective actions if a coagulation curve error occurs Congratulations. You have completed the Sysmex CS-2500 and CS-5100 System Coagulation Curve Errors Online Training course. Listed below are the key points that have been presented. Take time to review the material before you proceed to the final quiz. Identify the function of the multi-wavelength detection system 5 wavelengths (340, 405, 575, 660, and 800nm) Automatic wavelength switch Minimizes repeat testing Identify key areas of a normal reaction curve Percentage Detection Method  - Reaction Curve                 X-axis – time in seconds                 Y-axis – light transmission in milli-absorbance units (mA)                 Baseline (bH) – 0% point of the curve                 Endpoint – 100% point of the curve                 dH – difference in light transmission between the baseline and the endpoint                 Clotting time – 50% point of the curve   Navigate software browser screen to view reaction curves Browser Screen  - Sample information area                 Patient Information                 Analysis status                 Validation status                 Error flags                 Sample Info (Vol)  - Reaction Curve display area                 Displays reaction curves and results  - Browser Detail Screen                 Parameter information display area                 Displays sample number, date/time, assay group and a Detail button                 Detail button – detailed information related to the abnormal analysis result is displayed                 Detailed display  - Displays the reaction curve  - Evaluation Info – displays the reaction curve information bH (base height), dH  - Evaluation Data – displays the result data from 0 – 100% of the coagulation  - Measurement Info – displays temperature, detector channel, dilution ratio, level check for Vol Identify analysis data errors Detailed information can be found in the Browser detail screen    - Slight Coagulation Error – extremely weak clot, due to low fibrinogen concentration, issue with sample, incorrectly drawn or reagent  - Analysis Time Over – coagulation curve did not finish with in the detection time due to low coagulation activity, low fibrinogen concentration or an issue with the sample or reagent  - Coagulation Curve Error – abnormal fluctuation change in the coagulation curve, common cause is an air bubble  - Early Reaction Error – abnormal early or slow reaction detected in the aPTT coagulation reaction  - Noise Check Error – coagulation curve may have been contaminated with some kind of noise  - Turbidity Level Over – sample turbidity was too high and the transmitted light was too low  - No Coagulation – coagulation reaction was undetectable due to low fibrinogen concentration, over anticoagulated sample or reagent problem  - Flat Curve Error – coagulation reaction was undetectable due to low fibrinogen concentration, over anticoagulated sample or reagent problem Identify corrective actions All analysis data error corrective actions start with: Check the sample for possible anticoagulant contamination, hemolysis, lipemia, etc. Verify delivery of sample and reagent  Slight coagulation Reanalyze the sample Analysis result may be reported if reanalysis produces a result without an error or the repeat and initial results are equivalent. The mean of the results may be reported as determined by your laboratory policy Analysis Time Over Reanalyze the sample using a longer measurement time Analysis result may be reported if reanalysis produces a result without an error Coagulation Curve Error Reanalyze the sample Analysis result may be reported if reanalysis produces a result without an error or the repeat and initial results are equivalent. The mean of the results may be reported as determined by your laboratory policy Early Reaction Error Reanalyze the sample Verify the error code number of the test result on the Browser screen by pressing the Details key Error 0008.0128.0004 may be reported after a visual assessment of the curve. Verify the result and reaction curve agree If the error persists, follow your laboratory policy Noise Check Error Recalibrate the lamp or replace with a new lamp Reanalyze the sample Analysis result may be reported if reanalysis produces a result without an error. If reanalysis produces Noise error again, contact Support for assistance Turbidity Level Over Reanalyze the sample Analysis result may be reported if reanalysis produces a result without an error. If ‘Turbidity Level Over’ message appears again, follow your laboratory policy No Coagulation Error Reanalyze the sample If analysis result gives ‘No Coagulation’ message again, follow your laboratory policy Flat Curve Error Reanalyze the sample using a longer measurement time If analysis result gives ‘Flat Curve' message again, follow your laboratory policy The Sysmex CS-2500 and CS-5100 multi-wavelength detection system includes: 5 wavelengths (340, 405, 575, 660, and 800 nm) Automatic wavelength switch Minimizing the need for repeat testing. Multi-Wavelength Detection System Learn about the Simultaneous Multi-Wavelength Detection System. Simultaneous Multi-Wavelength Detection System The Sysmex CS-2500 and CS-5100 System provides simultaneous multi-wavelength scanning of clotting reactions at 340, 405, 575, 660, and 800 nm.    Since multiple wavelengths can be evaluated by each detector well, a sample with an analysis error in the main wavelength also is evaluated by another wavelength*. This function makes it possible to obtain a result on the first attempt minimizing repeats.   *Wavelength switch will occur if the clotting assay allows for a sub-wavelength to be used.   Detection Methods Learn more about the Detection Methods on the Sysmex CS-2500 and CS-5100 System. Tab TitleTextClotting Wavelengths: 405, 660, 800nm Assays: US: PT, aPTT, Fibrinogen, Extrinsic Factor Assays (II, V, VII, X), Intrinsic Factor Assays (VIII, IX, XI, XII), Lupus, Protein C, Factor V Leiden Outside the US (OUS): PT, aPTT, Fibrinogen, Thrombin Time, Extrinsic Factor Assays (II, V, VII, X), Intrinsic Factor Assays (VIII, IX, XI, XII), Lupus, Batroxobin Time, Protein S, Protein C, Factor V Leiden Percent Detection method: Detects change in transmitted light Clotting time is measured Clot time read at 50% point of reaction curve      Chromogenic Wavelengths: 340, 405nm Assays: US: AT, Heparin, Protein C OUS: AT III, α2-Antiplasmin, Plasminogen, Protein C, Coagulation Factor XIII, Factor VIII Chromogenic, Heparin, C1-Inhibitor, Dabigatran Rate method: Process of color emission by a chromogenic synthetic substrate Change in light absorbance is calculated      Immunologic Wavelengths: 575, 660, 800nm Assays: US: D-Dimer OUS: D-Dimer, VWF:Ag, Free Protein S Antigen Rate method, VLin method: Process of antibody-sensitive reagent reacting with antibodies Change in light absorbance is calculated      The Sysmex CS-2500 and CS-5100 system Browser software screen displays the reaction curves and analysis results.   The following information is displayed in the Browser screen: Reaction curve Sample analysis status Validation status Flags Error details Browser Software Screen Learn more about the Browser Software Screen. Instructions:Flash File:/content/generator/Course_90020481/1_sim_CS51_CCE_JoblistNav_800x640_4/1_sim_CS51_CCE_JoblistNav_800x640_4.htmHTML5 File:/content/generator/Course_90020481/1_sim_CS51_CCE_JoblistNav_800x640_4/index.htmlPDF File: The Sysmex CS-2500 and CS-5100 System Joblist screen status displays: Status Analysis status Background color  Review  Analysis completed but there is an assay group that requires confirmation  Yellow  Error  Analysis completed but there is an assay group that has an error  Red   Joblist Analysis Flags Learn more about the Joblist analysis flags.   Analysis Result / Flag Meaning  *  Low-reliability analysis result, or duplicated analysis results are significantly different  ***.**  Analysis result could not be obtained due to an error  ---.--  Calculated parameters could not be calculated  xxx.xx  Calibration curve not validated,  preventing calculated parameter  +++.++  Number of displayed digits exceeded  ///.//  Input value error occurred during average calculation process of duplicated analyses     Error Codes and Corrective Actions Learn about common analysis data errors and their corrective action. Select the tabs below to learn about the common analysis data errors and their corrective action.TitleTextSlight Coagulation ErrorTab TitleTextError Code Error Code: 0002.0000.0000 Possible Causes: The detected coagulation reaction was extremely weak due to: Sample with low fibrinogen concentration, factor deficiency or the presence of inhibitors Problem with the sample Problem with the reagent Corrective Action Corrective Action: Verify delivery of sample and reagent Review the analysis data for clot formation. A weak clot formation may be due to an abnormally low fibrinogen level, factor deficiency, or the presence of inhibitors Reanalyze the sample Reportable Result: Reanalysis produces a result without an error, the result may be reported If slight coagulation occurs again, and if the curves are acceptable and the repeat results and initial results are equivalent at the 50% coagulation detection point, the mean of the two results may be reported as determined by your laboratory policy      Analysis Time OverTab TitleTextError Code Error Code: 0004.0000.0000 Possible Causes: The coagulation reaction did not finish within the detection time due to: Sample with low coagulation activity Sample with low fibrinogen concentration Problem with the sample Problem with the reagent      Corrective Action Corrective Action: Check the sample for possible anticoagulant contamination, hemolysis, lipemia, etc. Verify delivery of sample and reagent Repeat the measurement with a longer measurement time. This step is effective to confirm whether the coagulation curve produces a plateau in the longer time Reportable Result: Reanalysis produces a result without an error, the result may be reported If reanalysis gives an "Analysis Time Over" message again, the sample may not be capable of forming a firm clot. Follow your laboratory policy      Coagulation Curve ErrorTab TitleTextError Code Error Code: 0008.00XX.0000 Possible Causes: An abnormal fluctuation was found in the coagulation curve due to: Bubble in the reaction cuvette Artifact in the reaction cuvette      Corrective Action Corrective Action: Check the sample for possible anticoagulant contamination, hemolysis, lipemia, etc. Verify delivery of sample and reagent Review the analysis data Reanalyze the sample Reportable Result: Reanalysis produces a result without an error, the result may be reported If Coagulation Curve Error occurs upon reanalysis, and if the curves are acceptable and the repeat and initial results are equivalent at the 50% coagulation detection point, the mean of the two results may be reported as determined by your laboratory policy      Early Reaction ErrorTab TitleTextError Code Error Code: 0008.0128.00XX Possible Causes: An abnormal early or slow reaction was detected in the aPTT coagulation reaction due to: Possible anticoagulant contamination Poor sample integrity      Corrective Action Corrective Action: Check the sample for possible anticoagulant contamination, hemolysis, lipemia, etc. Verify delivery of sample and reagent Verify the error code number of the test result on the Browser screen by pressing Details key Reanalyze the sample Reportable Result: If repeat is free from error, you may release the result Start Angle 2, Error 0008.0128.0004 can be released after a visual assessment of the curve. Verify that the result and the reaction curve agree Follow your laboratory policy to result the following: Slow Reaction, Error 0008.0128.0001 Start Angle 1, Error 0008.0128.0002 Drift, Error 0008.0128.0008 Early %, Error 0008.0128.0016      Noise Check ErrorTab TitleTextError Code Error Code: 0008.0256.0000 Possible Causes: The coagulation curve reaction may have been contaminated with some kind of noise due to: Change in signal Problem with the lamp      Corrective Action Corrective Action: Check the sample for possible anticoagulant contamination, hemolysis, lipemia, etc. Verify delivery of sample and reagent Recalibrate the lamp or replace it with a new lamp. A new lamp requires a lamp calibration. After performing the lamp calibration, perform QC analysis to check analysis data and perform calibration curve analysis if necessary Reanalyze the sample Reportable Result: Reanalysis produces a result without an error, the result may be reported If sample, reagent and instrument conditions are acceptable, reanalyze the sample and confirm clot formation in the reaction cuvette or follow your laboratory policy If reanalysis produces Noise error again, contact Support for assistance      Turbidity Level OverTab TitleTextError Code Error Code: 0016.0000.0000 Possible Causes: The transmitted light was extraordinarily low level due to: Sample turbidity too high        Corrective Action Corrective Action: Check the sample for possible anticoagulant contamination, hemolysis, lipemia, etc. Verify delivery of sample and reagent Reanalyze the sample Reportable Result: Reanalysis produces a result without an error, the result may be reported If reanalysis gives a "Turbidity Level Over" message again, the sample may not be capable of forming a firm clot. Follow your laboratory policy     No Coagulation ErrorTab TitleTextError Code Error Code: 0032.0000.0000 Possible Causes:    The coagulation reaction was not detectable, due to: Low fibrinogen concentration Over anticoagulated sample Problem with the reagent               Corrective Action Corrective Action: Check the sample for possible anticoagulant contamination, hemolysis, lipemia, etc. Verify delivery of sample and reagent Reanalyze the sample. For fibrinogen, if auto-redilution is not set, change the dilution ratio and reanalyze Reportable Result: Reanalysis produces a result without an error, the result may be reported If reanalysis gives “No Coagulation” message again, the sample is below the detection limits of the detector. Follow your laboratory policy      Flat Curve ErrorTab TitleTextError Code Error Code: 0032.0002.0000 Possible Causes:    The coagulation reaction was not detectable, due to: Low fibrinogen concentration Over anticoagulated sample Problem with the reagent               Corrective Action Corrective Action: Check the sample for possible anticoagulant contamination, hemolysis, lipemia, etc. Verify delivery of sample and reagent Repeat the measurement with a longer measurement time (ex. PTX) Reportable Result: Reanalysis produces a result without an error, the result may be reported If reanalysis at a longer measurement time produces Flat Curve again, follow your laboratory policy      Time (sec) Light Transmission (mA) Baseline (bH) 0% Endpoint 100% dH Clotting Time 50% Please note that the learning material is for training purposes only!   For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator's Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions.   Note: Some functions shown in this material are optional and might not be part of your system.   Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country.  Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Copyright © Siemens Healthcare GmbH Published by Siemens Healthcare GmbH ©  Siemens Healthcare GmbH, 2018