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Stratus® CS Acute Care™ Diagnostic System Sample Processing Online Training

Identify available tests and sample types. Perform Daily Setup. Identify the necessary consumables to process samples. Explain storage requirements for consumables. Process patient samples. Interpret patient sample results. This clinical laboratory training qualifies for continuing education units (CEU).

Welcome to the Stratus® CS Acute Care™ Diagnostic System Sample Processing Online Training course.  The content in this course provides you with a foundational knowledge to process patient samples with accuracy and precision.   Select Next to continue.   Distinguish between various tube types and sample types Explain Sample Handling and Reagent Storage Identify the steps to process a sample Recognize when and how to process a dilution sample Review reports and explain the results Upon successful completion of this course, you will be able to: Select Next to continue. Congratulations.  You have completed the Stratus® CS Acute Care™ Diagnostic System Sample Processing 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. Explain Sample Handling and Reagent Storage:  Proper mixing: Gently invert sample 8-10 times, do not shake Tubes must be adequately filled TestPaks and DilPaks: DilPaks are stored in the refrigerator (2-8°C), and can go directly on the Analyzer without warming up Do not open TestPak(s) until ready for use.  Each TestPak contains sufficient reagent to complete one test.  Each DilPak contains sufficient method-specific diluent to dilute one sample.  TestPaks and DilPaks require no mixing or shaking. Once removed from the packaging, handle by the edges only. Do not open until ready for use Place flat in the Pak Manager, arrow facing inward. Do not push the Pak into the slot. Distinguish between various tube types and sample types: Tube types: Sodium Heparin Lithium Heparin Sodium Citrate Several Manufacturers of tubes available. Use only the ones recommended by the manufacturer in the Stratus® CS Operator's Guide. Whole Blood Samples: Use the Clear Cannula with Becton-Dickinson Tubes Use the  Green Cannula with SARSTEDT Monovette® Tubes Plasma: Sample cups: holds 500µl, 100µl per test and 100µl dead space Previously spun samples or dilution samples Identify the steps to process a sample Gently invert sample 8-10 times. Compare the volume against the volume gauge. Do not pierce the tube stopper. Do not push paks into the slot. Make sure all instrument's red checklist lights are out and the green Start key is lit prior to pressing the Start key. Review reports and explain the results: Sample Result Symbol Result is outside the defined reference interval  *** prints next to result Result is above the cutoff Above Cutoff of will appear Result is above the assay range *** replace the result If an Error occurs during processing, an alarm sounds.  Press any key on the keypad to turn it off.  The word Error will print on the report slip.  You will need the Error Code to troubleshoot the error (see Operator's Guide for error codes).  Recognize when and how to process a dilution sample: A dilution is a common laboratory technique used to obtain the desired concentration. A dilution will always reduce the concentration of the sample.  Dilutions are ratios and are generally expressed in terms of whole numbers. Automatic Dilution: When the result is above the assay range and you have run fewer than four tests on the rotor, you can rerun the sample as a dilution by adding a DilPak and a new TestPak. Manual Dilution: When you rerun the test as a dilution and it is still above the assay range, you can make a manual dilution and rerun the sample using a Sample Cup.  See the appropriate assay IFU’s for details.   The result shown on the screen, the printed report and the result transmitted to the LIS is corrected to the dilution factor that you entered. Always follow proper Laboratory procedures in making a manual dilution. Select Next to continue.   Specimen Collection Before processing a sample, be sure that the daily setup procedures have been performed on your Stratus® CS system.   Successful processing can depend on good phlebotomy technique. Reference the CSLI guidelines for the Collection of Diagnostic Venous Blood Specimens. Use only collection tubes qualified for use on the Stratus® CS analyzer. Important information about specimen collection is included in the Specimen Collection section of the TestPak insert sheets and in the tube manufacturer’s instructions.  Gentle mixing, inverting sample 8-10  times immediately after specimen collection is preferred, taking care not to shake or compromise the sample integrity. For additional information regarding the acceptable anticoagulants and individual Test Tube types, refer to the Stratus® CS Operator's Manual and analyte TestPak Package Inserts. Reagent Storage The reagents are stored in the refrigerator 2-8°C.   They can be taken out of the refrigerator and installed onto the system as needed.  Select Next to continue.   Most of the tests performed on the Stratus® CS Analyzer can be performed in B-D Sodium Heparin tubes.  Please refer to the chart on the right for more information regarding alternate tube selections.  For a larger image refer to the Stratus® CS Operator's Manual.  Note that the DDMR TestPak requires either the Sodium Citrate anticoagulant or the Lithium Heparin anticoagulants to be used.   Also pay attention to the fill volumes of the individual tubes selected due to the anticoagulant blood ratio volume. The tests listed below use Lithium or Sodium Heparin Anticoagulants: βHCG CKMB Troponin (CTNI) Myoglobin (MYO) NT proBNP (pBNP) hsCRP The test listed below uses Lithium Heparin or Sodium Citrate Anticoagulants: D-dimer (DDMR) Select Next to continue.   Process samples using whole blood or plasma Whole Blood Samples: Collected in the Venipuncture tubes described earlier in the course Plasma Samples:  Previously centrifuged,  which separates the plasma from the cells   Sample Types Learn about the different types of samples. Tab TitleTextSample Collection Tubes There are several different manufacturers of venipuncture tubes.  When processing samples with whole blood using venipuncture method, it is important to use only the tubes that do not contain separation gel.  One manufacturer is the Becton-Dickinson tube,  which contains Sodium Heparin, Lithium Heparin or Sodium Citrate.  Each sample tube contains the appropriate amount of anticoagulant combined with proper mixing to keep your sample from clotting.  It is very important that the tubes are adequately filled.  The Sodium Citrate tube for the DDMR must be completely filled. Comparing your collection tube to the sample gauge on the left of the Stratus® CS system will allow you to verify the collection volumes.  Use the clear color cannula with the Becton-Dickinson tubes. Another manufacturer is Sarstedt.  If you are using the Sarstedt tube, which also contains Sodium Heparin or Lithium Heparin, use the fill line on the tube, not the sample volume gauge to determine if there is sufficient sample. Use the Green colored cannula with these tubes.     The venipuncture tubes hold approximately 4ml and will dispense approximately 3ml of sample into the rotor containing an evenly distributed gel to be centrifuged.  This gel will separate the cells from the plasma and prepare the sample for processing.   If the sample level in the tube is lower than the level shown on the gauge or the fill line, do not use the tube.  Draw  a new sample or centrifuge the sample externally and transfer the plasma to a sample cup for processing. When complete, select the X in the upper-right corner to close the window and continue. Sample Cups The sample cups have a conical shaped bottom (dead space), which requires 100 µl of additional sample. Each test requires 100 µl of sample.  To process up to four tests, you must have a minimum of 500 µl of sample in the sample cup. This sample process will require a previously spun sample.  Pipette carefully to prevent air bubbles in the sample.   When complete, select the X in the upper-right corner to close the window and continue.     Sample Processing using whole blood and venipuncture tubes. Select the links below to view the steps to process samples. Sample Processing Learn how to process Venipuncture samples. Checklist TitleChecklist TypeChecklist ContentStep 1: Verify Sample VolumeHTML Select each checkbox to learn more about sample processing. To determine if you have enough sample to process up to four tests, measure the sample tube against the sample volume gauge found on the front of the instrument.  For Sarstedt tubes use the fill line on the tube, not the sample volume gauge. If the sample level in the tube is lower than the level shown on the gauge or the fill line on the tube.  Do not use the tube.  You can draw a new sample or centrifuge the sample externally then transfer the plasma to a sample cup for processing. Step 2: Scan Barcode LabelHTML Ensure you are on the Patient Mode screen and Scan the barcoded label on the sample tube to enter the appropriate patient information.  This will help eliminate any patient misinformation that may occur with manual entry.   To scan, move the label across the front of the reader. Step 3: Verify Patient InformationHTML   After scanning the barcoded label, verify on the patient mode screen that the patient ID or sample ID have been scanned.  If there is no ID present, you can enter it using the keypad.  Step 4: Process the SampleHTML Invert the sample tube 8-10 times to ensure uniform resuspension of the red cells for proper sample handling.  Gently place the tube, top down, into the cannula.  Make sure it snaps into place.  DO NOT PIERCE THE TUBE STOPPER.  Select the play arrow to begin the video.  When complete, select the X in the upper-right corner to close the window and continue. Sample Cup Processing Learn how to process Sample Cups. Checklist TitleChecklist TypeChecklist ContentStep1: Pipette plasma into sample cupHTML Select each checkbox to learn  how to process sample cups. To process plasma using a sample cup it is important to pipette enough sample to run all the necessary tests.  Each sample takes 100 µl and the sample cup having a conical design will have a dead space of 100 µl.  To run 4 tests you will need 500 µl.  It is important to also make sure that the sample does not contain any particulates or bubbles because these will interfere with the processing of your samples. Pipette the plasma into the cup carefully to prevent bubbles.  Make sure there are no particulates in the sample and that there are no air bubbles on the surface.  Fill the sample cup to the bottom edge of the rim (500 µl).  Step 2: Place Sample Cup in rotor plateHTML Carefully place the sample cup in the cup position on the rotor table.  Make sure it is seated firmly in position.  Step 3: Enter Patient informationHTML   Use the keypad to enter the patient ID and/or Sample ID.  Press the enter key after each entry. Continue entering each data entry field according to your facility, making sure to press the enter key after each entry.   Step 4: Add the TestPaksHTML The TestPaks are stored in the refrigerator (2-8°C).  They should not be taken out prior to use. The TestPaks contain sufficient reagent to process a single test.  Remove the Paks from the packaging, making sure to hold them by the edges. Do not shake or mix the TestPaks.  Place the TestPaks flat in the Pak Manager well, making sure the arrow on the pak label points toward the instrument.   DO NOT PUSH PAKS INTO THE INSTRUMENT. Step 5: Close the doorHTML   Close the sample door.  Step 6: Press StartHTML   Make sure all red checklist lights are out and the instrument green Start light on the front right of the instrument is on. (If the light is off, pressing the start key displays troubleshooting information.) Press the Start key to begin processing.  The Stratus® CS Analyzer will begin displaying results within 15 minutes.  All results are displayed within 30 minutes. If the sample retrieve option is OFF, the cup goes to the waste container automatically. If the sample retrieve option is ON, the screen will display the following message: Sample being moved out, please wait.  Holding the sample for retrieval press F4 to continue. If you want to keep the sample for further use, remove the cup from the instrument and press F4. If you do not want to keep the sample, press F4 to place the cup in the waste container. When complete, select the X in the upper-right corner to close the window and continue.  This example is a patient that is 55 years old and presented with malignant melanoma for staging. The clinical findings show two hypermetabolic lesions located at the left lower leg suggestive of tumor manifestation.  In addition one liver metastasis can be visualized. Diffuse elevated uptake in the left inguinal area caused by recent lymph node excision.   When all tests are processed, the system automatically prints a report slip with all results for the sample.  Use the data on this report to analyze the results.  If there is an error with one or more results, a message prints on the report.  To view the actual error code you must display or print the error log.   Analyzing Results Learn how to interpret results. Slide NumberText BlocksCalloutsAudio ScriptImage File1 Use following symbols to help you understand your sample results:   Sample Result Symbol Result is outside the defined reference interval  *** prints next to result Result is above the cutoff Above Cutoff of will appear Result is above the assay range *** replace the result   When this appears you have the option of rerunning the test as a dilution.   Select Next to continue.   Note: If audio does not automatically start, select the play arrow in the top left to begin.If a test result is outside the defined reference interval, asterisks are printed next to the result on the report slip. If a test result is above the cutoff value, the message ABOVE CUTOFF value appears. Refer to your Stratus® CS Operator's Guide for the procedure to use cutoff values. If a test result is above the assay range, asterisks replace the result, and the message Above Assay Range is printed on the report slip. In this case you have the option of rerunning the test as a dilution. 2 If another copy of the report is needed you can follow these steps to reprint the sample report. From any mode screen, press F4 [Menus] Press F3 [Reports] Press F1 [Print Results] Enter the number of sample results you want to print.  The most recent sample prints first. Press the enter key. Select Next to continue.  The instrument automatically prints the sample report slip upon completion of testing. In the event that you need an additional copy of the sample report slip, as an example for different Doctor or charting you can follow the steps below to reprint your sample report. The instrument stores results for the last 20 samples processed. The most recent sample will print first. From any mode screen you will press F4 Menus. Then you will press F3 Reports. Press F1 to access Print Results. Enter the number of samples to reprint and Press the enter key. 3 If an error occurs during processing you may need to view or print the error code for Troubleshooting purposes.   You can print one error code or you can print the entire error log.   Follow these steps to print One Error Code: From any mode screen: Press F4 [Menus] Press F3 [Reports] Press F4 [System Status] Press F3 [Error Log] Move the cursor to the error you want to print. Press F4 [More Info] to print the error Select Next to continue.  If an error occurs during processing, the alarm may sound. Press any key on the keypad to turn of this alarm. The word Error appears on the instrument screen display and on the report slip. You must display or print the error log to find the error code. In the event that there are multiple errors, troubleshoot the errors starting with the one that occurred first, closest to Run Time on the report slip. The Stratus® CS Operator’s Guide includes an error code list. When you determine the error code you can refer to the Troubleshooting section in your Stratus® CS Operator's Guide for the procedure to follow.4 Printing the entire error log shows the error code, the associated error message, the time and the date for the error.  The most recent errors will be listed first.  The Stratus® CS Analyzer will store up to 50 errors.  To print the Entire Error Log follow these steps.  From any mode screen: Press F4 [Menus] Press F3 [Reports] Press F4 [System Status] Press F3 [Error Log] Press F3 [Print Log] to print the entire list of errors. To stop print, press the red Stop Test key.  When printing is complete press the paper advance key and the exit key at the same time to return to the mode screen. When complete, select the X in the upper-right corner to close the window and continue.Printing the entire error log shows the error code, the associated error message, the time and the date for the error. The most recent errors will be listed first. The Stratus® CS Analyzer will store up to 50 errors. To print the Entire Error Log follow the steps listed which can be performed from any mode screen. Hello and welcome to this combined eLearning session where we will explore Mammography Techniques and DICOM Workflow. This eLearning is a collaborative effort by Karen Devoid who is a Clinical Education Specialist and Dave Randolph who is a Senior Technical Instructor. As technologist’s we are often consumed with the tools that are needed to perform our everyday responsibilities but it is also important to know what happens to image transfer behind the scenes. Take this opportunity to have a better understanding of what happens behind the scenes. When the result is above the assay range for the method, the report will show ***  instead of a value to indicate the result is above the assay range.  The message Above Assay Range will also print on the report slip.  If you have run fewer than four tests on the rotor, the screen will also display the message: Do you want to run a dilution? A dilution is a common laboratory technique used to obtain the desired concentration. A dilution will always reduce the concentration of the sample.  Dilutions are ratios and are generally expressed in terms of whole numbers.  The value is then reported out using the dilution factor that you entered.   You will need a new TestPak and a method specific DilPak for the required assay.  Place the TestPak and the DilPak in the pak manager well, ensuring that the arrows point toward the system and the paks are seated flat and secure.  Press F4, then press the Start key.   Processing a Dilution Learn how to process a sample dilution. Tab TitleTextProcessing an Automated Dilution When the result is higher than the assay range and the result has been replaced with *** , the message Above Assay Range prints on the report slip.  You have the option to rerun the sample as a dilution. If you have run fewer than four tests on the rotor, you will be prompted to run a dilution. The screen will display the message:  Do you want to run a dilution?  If you choose to run a dilution, you will need a new TestPak and a DilPak.  The DilPaks are stored in the refrigerator (2-8°C) and should not be taken out until ready for use.  The DilPak contains sufficient method-specific diluent to dilute one sample. Once you remove the DilPak from the packaging be sure to hold it by the edges.  Do not shake or mix.  Place the DilPak and the TestPak flat on the Pak Manger with the arrow facing toward the instrument.  The results will display the message Corrected for DilPak on the report slip. Follow the steps below to run a dilution: Place a new TestPak and a DilPak for the method to be tested in the Pak Manager well. Press F4 [yes]. Press the Start key. The results report for a diluted sample displays the message: Corrected for DilPak that indicates the sample processed successfully.      Processing a Manual Dilution If you have processed a dilution using a DilPak and the result is still above the assay range, you can rerun the sample as a Manual Dilution.  Refer to the appropriate Assay Instructions For Use (IFU) for details. The Manual Dilution feature must first be enabled to process a manual dilution.  Instructions to enable the feature can be found in the Stratus® CS Operator's Guide. To process Manual Dilution: Place 500µl of the diluted sample in a Sample Cup. Place the sample cup in position on the Rotor Table. From the Mode screen, Press F1 [Manual Dilution Mode]. Enter the dilution factor and press the Enter key. Press F4 [Accept]. The result will be corrected for this factor, and the Patient Mode screen will be displayed with the manual dilution factor entered.       Next: Enter the Patient ID. Enter the Sample ID. Enter the Operator ID (optional). If collection time entry is required, press F1 [Collection Time]. Enter the time and date, pressing enter after each entry. Press F4 [Accept] to store the information.  The screen will return to the Patient Mode display. Press the Start key. Once the test has completed, the result shown on the screen, printed on the report, and transmitted to the Laboratory Information System (LIS) is corrected for the dilution factor that you entered. The Results report for a manually diluted sample displays the message: Corrected for a Manual Dilution indicating that the test processed successfully. When complete, select the X in the upper-right corner to close the window and continue.

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