Stratus® CS 200 Acute Care Analyzer Sample Processing Online Training

Welcome to the Stratus® CS 200 Acute Care Analyzer Sample Processing Online Training course. The content in this course provides you with the foundation to successfully process patient samples to ensure efficient operation of the instrument. Select Next to continue. Distinguish between various tube types and sample types Identify Sample Handling and Reagent Storage Procedures Identify the steps to process a sample Identify when and how to process a dilution sample Review reports and evaluate the results Upon successful completion of this course, you will be able to: Select Next to continue. Congratulations.  You have completed the Stratus® CS 200 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. Identify Sample Handling and Reagent Storage Procedures:  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. 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 Stratus® CS 200 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: Venipuncture tubes Compare the volume against the volume gauge Scan barcode label Verify patient information Invert the stoppered tube gently a few times  Place tube in cannula. Do not pierce the tube stopper Load cannula/tube assembly Close the sample door Load a new rotor on the rotor table Load TestPaks.  Do not push paks into the slot Make sure all instrument's red checklist lights are out and the Start text is green Sample Cups Pipette plasma into a sample cup Place the sample cup on the rotor table Enter patient information Add TestPaks Close sample door Press Start Review reports and evaluate the results: Sample Result Symbol/Message Result is outside the defined reference interval  *** prints next to result Result is above the Cutoff Value Above Cutoff of Result is above the assay range ***AAR 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 Stratus® CS 200 Operator's Guide for errors).  Identify when and how to process a dilution sample: 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: Warning: manual dilution is not recommended for healthcare professionals in the point of care (POC) setting. 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, confirm that the Daily Setup procedures have been performed on the Stratus® CS 200 system. Successful processing depends on good phlebotomy technique. Use only collection tubes qualified for use on the 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. Reference the CSLI guidelines for the Collection of Diagnostic Venous Blood Specimens. Follow the specimen collection and handling section of Instructions for Use (IFU) before processing plasma specimens which have been frozen at -20 degrees Celsius or below.  For additional information regarding the acceptable anticoagulants and individual Test Tube types, refer to the Stratus® CS 200 Operator's Guide and analyte TestPak Instructions for Use. Reagent Storage The reagents are stored in the refrigerator at 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 200 Analyzer can be performed in B-D Sodium Heparin tubes.  Refer to the chart on this page for more information regarding alternate tube selections.  The DDMR TestPak requires either the Sodium Citrate anticoagulant or the Lithium Heparin anticoagulants to be used.   Note: Fill all sample collection tubes completely per manufacturer guidelines. These tests use Lithium or Sodium Heparin Anticoagulants: βHCG CKMB Troponin (CTNI) Myoglobin (MYO) NT proBNP (pBNP) hsCRP This test uses Lithium Heparin or Sodium Citrate Anticoagulants: D-dimer (DDMR) Note: Refer to the Stratus® CS 200 Operator's Guide for a larger version of the Sample Collection Tube Systems. Select Next to continue. Process samples using whole blood or plasma Whole Blood Samples: Collected in the Venipuncture tubes 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 the venipuncture method, it is important to use only the tubes that do not contain separation gel.  The Becton-Dickinson tube contains Sodium Heparin, Lithium Heparin or Sodium Citrate.  Each sample tube contains the appropriate amount of anticoagulant which, combined with proper mixing, prevents the sample from clotting.  It is very important that the tubes are adequately filled.  The Sodium Citrate tube for the DDMR must be completely filled. Compare the collection tube to the sample volume gauge located on the left of the Stratus® CS 200 system.  Use the clear color cannula with the Becton-Dickinson tubes. If you are using the Sarstedt tube, which also contains Sodium Heparin or Lithium Heparin, use the fill line on the tube. Note the sample volume gauge on the instrument 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. 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, a minimum of 500 µl of sample is required in the sample cup. This process requires 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 in venipuncture tubes and plasma in sample cups. Venipuncture tubes: Verify sample volume in venipuncture tube Scan barcode Verify patient information Place tube in cannula Insert cannula/tube assembly into sample manager Close sample door Place new rotor on rotor table Load TestPaks Select Start Sample cups:   Pipette plasma into a sample cup Place sample cup in the cup position on the rotor table Enter Patient ID Load TestPaks Close sample door Select Start Sample Processing Learn how to process Venipuncture samples. Checklist TitleChecklist TypeChecklist ContentStep 1: Verify Sample VolumeHTML 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.  Draw a new sample or centrifuge the sample externally then transfer the plasma to a sample cup for processing. Select each checkbox to learn more about sample processing. Step 2: Scan Barcode LabelHTML Access the Patient Mode screen.  Scan the barcoded label on the sample tube to enter the appropriate patient information.  Scanning the label will help avoid 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 Verify that the patient ID or sample ID has been scanned on the Patient Mode screen.  If an ID does not display, use the keypad to enter the required information.  Select Accept after all data has been entered.  Step 4: Place Tube in CannulaHTML Invert the stoppered tube gently a few times to ensure uniform re-suspension of the red cells.  Gently place the tube, top down, into the cannula.  Make sure it snaps into place.  Do not pierce the tube stopper.   Step 5: Insert Cannula/Tube AssemblyHTML Insert the cannula/tube assembly into the sample door opening.  Step 6: Close the DoorHTML Close the sample door.  Step 7: Load a New RotorHTML Place a new rotor on the rotor table.  Make sure that the small opening in the rotor and the embossed text are face up.  Seat the rotor firmly, flat on the table.  Step 8: Load TestPaksHTML Hold each TestPak by the edges and place flat into the Pak Manager well. Make sure the arrow on each TestPak label points toward the instrument.  Do not push the TestPak into the system.  Step 9: Select StartHTML Select Start. 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 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.  A volume of 500 µl is required to run 4 tests.  It also is important to make sure that the sample does not contain any particulates or bubbles which may interfere with the processing of a sample. 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) or refer to the Sample Cup Volume table in the Stratus® CS 200 Operator's Guide to determine the plasma amount required to perform the test.   Select each checkbox to learn how to process sample cups. Step 2: Place Sample Cup in Rotor TableHTML 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 touchscreen to enter the patient ID and/or Sample ID.  Press Enter after each entry. Select Accept when all data has been entered. Continue entering each data entry field according to your facility, making sure to press Enter after each entry.   Step 4: Add the TestPaksHTML The TestPaks are stored in the refrigerator (2-8°C) and they should not be taken out prior to use. The TestPaks contain sufficient reagent to process a single test.  Remove the TestPaks 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 the 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 Start button text is green on the front right of the instrument. If the light is off, pressing the Start button displays troubleshooting information. Press Start to begin processing.  The 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 sample for retrieval press continue. If you want to keep the sample for further use, remove the cup from the instrument and press continue. If you do not want to keep the sample, press continue to place the cup in the waste container. When complete, select the X in the upper-right corner to close the window and continue. 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.  The actual error code can be displayed onscreen or printed from the error log. Analyzing Results Learn how to interpret results. Slide NumberText BlocksCalloutsAudio ScriptImage File1 Use the following symbols/messages to help you understand your sample results:   Sample Result Symbol/Message Result is outside the defined reference interval  *** prints next to result Result is above the Cutoff Value Above Cutoff of Result is above the assay range Above Assay Range ***AAR replaces 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 the Stratus® CS 200 Operator's Guide for the procedure to use cutoff values. If a test result is above the assay range, asterisks and A A R 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 Reprint the sample report: From the Home screen, select Menus Select Reports Select Print Result Enter the number of sample results you want to print.  The most recent sample prints first. Select Enter Select Print Select Next to continue. The instrument automatically prints the sample report slip upon completion of testing. If needed, an additional copy can be printed. The instrument stores results for the last 50 samples processed. The most recent sample will print first. From the Home screen, select Menus, select Reports and then Print Results. Enter the number of samples to reprint, select Enter and then press Print. 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 the Home screen, select Menus Select Reports Select System Status Select Error Log Use the arrows to select the error information to print Select 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 off the alarm. The word Error appears on the instrument screen display and on the report slip. You can view the error codes from the touchscreen or print the error log. 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 200 Operator’s Guide includes an error code list. When you determine the error code, refer to the Troubleshooting section in the Operator's Guide for the procedure to follow.4 Printing the entire Error Log shows the error code, the associated error message, and the time and the date for the error.  The most recent errors will be listed first.  The Stratus® CS 200 Analyzer will store up to 50 errors.    Follow these steps to print the entire Error Log: From the Home screen, select Menus Select Reports Select System Status Select Error Log Select Print Log to print the entire list of errors. To stop printing, select Stop.  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 200 Analyzer stores up to 50 errors. The Entire Error Log can be printed from any mode screen. When the result is above the assay range for the method, the report will show ***AAR  instead of a value.  The message Above Assay Range also prints on the report slip.  If fewer than four tests have been run on the rotor, the screen displays the message: Do you want to run a dilution? A dilution is a common laboratory technique used to obtain the desired concentration. A dilution always reduces the concentration of the sample.  Dilutions are ratios and generally expressed in terms of whole numbers.  The value is then reported out using the entered dilution factor. Processing a Dilution Learn how to process a sample dilution. Tab TitleTextProcessing an Automated 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. After removing it from the packaging, be sure to hold the DilPak by the edges.  Do not shake or mix.  Place the DilPak and the TestPak flat on the Pak Manager 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: Select Yes on the Do you want to run a dilution? prompt Place a new TestPak and a DilPak for the method to be tested in the Pak Manager well. Select Start 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. Warning: Manual dilution is not recommended for healthcare professionals in the point of care (POC) setting. 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 200 Operator's Guide. To process Manual Dilution: From the Home screen, select Change Mode Select Man Dil Mode Enter the dilution factor and select Enter Select Accept Select Home and enter the Patient ID/Sample ID and Operator ID(optional) If collection time entry is required, select Collection Time and enter the time and date. Select Accept Place 500µl of the diluted sample in a Sample Cup. Place the sample cup in position on the Rotor Table. Select Start     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.