INNOVANCE® PFA-200 System Quality Control Online Training

Welcome to the INNOVANCE® PFA-200 System Quality Control Online Training course. The QC features of the system include: A built in QC program Lot-specific onboard QC storage User definable QC reference ranges Select Next to begin. Demonstrate how to perform a Self Test Demonstrate how to run normal control samples Describe how to establish a normal control donor group Describe how to evaluate QC results Upon successful completion of this course, you will be able to: Select Next to continue. When should you perform a Self Test?  Every 24 hours At the start of each shift that the system is in use After the system initializes and completes power-on diagnostic tests Download and print a copy of the Quality Control and Maintenance form. Performing a Self Test Learn how to perform a self test. Checklist TitleChecklist TypeChecklist ContentInitiate the Self TestHTML NOTE:  On the Maintenance Menu, verify that the system is at the operating temperature (37.9°C±1°C) before beginning. To initiate a self test, proceed as follows: On the Maintenance Menu screen, tap System Check.  Tap Self Test.  Select each checkbox to learn more about performing a self test.    Load Cassettes & CartridgesHTML When prompted by the software: Insert a new vacuum cup into each priming cartridge. Load the priming cartridges in positions A and B of the cassette. Place the cassette onto the carousel. Optional:  Place a new target paper on top of the vacuum cup in position B. On the screen, tap Continue.  The Self Test starts.  The current status is displayed.  Load Foam Pad and IsopropanolHTML When prompted by the software: Load a new cleaning pad in the carousel well. Apply 4 to 5 drops of isopropanol to the center of the cleaning pad. With a gloved index finger, tap gently on the cleaning pad 2 to 3 times to help distribute the isopropanol. On the screen, tap Continue. The self test progress will display and icons will appear in the status bar indicating its status.  Complete the Self TestHTML When prompted by the software: Using tweezers, remove the cleaning pad.  Discard the cleaning pad in a suitable biohazard waste container. Tap Continue on the screen. When the self test is finished, a corresponding message is displayed and the maintenance symbol disappears. If printing the results of self tests is activated, the results are printed. Tap Continue on the screen.  Check Trigger Solution DispensingHTML Verify that the trigger solution is dispensing correctly: Remove the cassette carefully from the carousel. Visually check the trigger solution dispensing in position B. Without the Target Paper: Check if the trigger solution is dispensed on the raised platform of the vacuum cup. The size and exact centering of the drop is not critical. If there is a drop visible on the platform, the trigger solution dispensing is adequate. If there is no drop visible on the platform, contact the Siemens service. With Target Paper (optional): Check if the trigger solution is dispensed in the target circle and touches the black dot in the center of the target. The size and exact centering of the drop is not critical. If the drop does not touch the center of the target, contact the Siemens service. Discard ConsumablesHTML After completing the trigger solution dispense verification, you now have to discard the consumables. Remove the priming cartridges. Remove the vacuum cup and, if applicable, the target paper from both priming cartridges with a gloved index finger. Discard the vacuum cups and, if applicable, the target paper in a suitable biohazard waste container. Rinse both priming cartridges with distilled or deionized water. Save the priming cartridges for further use.  Add Trigger Test to Maintenance HistoryHTML If the trigger solution has dispensed correctly: In the Help Menu screen, tap History. Tap Add Event. Tap M100 Trigger Test Verified. Tap Select. Tap Yes. The trigger test is added to the maintenance history: If the self test is passed without any error, you can now perform tests. If the self test fails, refer to the INNOVANCE® PFA-200 System Instruction Manual for more information. When complete, select the X in the upper-right corner to close the window and continue.    Refer to the following guidelines to establish your control donor group: Select potential donors who are free from any medications known to affect platelet function Test each potential donor by performing two replicates with COL/EPI cartridges only. Use the handy Donor Control Group Form job aid later in this course to record your results Qualify a donor if the mean CT result falls within the mean CT ± 25 seconds of the reference range established by your laboratory, and the CV is less than or equal to 15%. Refer to the Quality Control section of the package insert as a guideline Download and print a copy of the Establishment of Control Donor Group Data Form.   Establishing Reference Ranges Learn More about establishing reference ranges. If your lab collects samples in 3.8% sodium citrate, you can use the reference range listed in the package insert sheet provided with every shipment of INNOVANCE® PFA-200 test cartridges as a general guideline to determine if donors qualify for inclusion in a donor pool. If your lab collects samples in 3.2% sodium citrate, you may subtract up to 12% from the lower and upper limit of the listed reference range to establish a general guideline for samples collected in 3.2% sodium citrate. For example:  Lower limit = 94 - (94 x 0.12) = 83 Upper limit = 193 – (193 x 0.12) = 170   You should eventually establish your own quality control reference range based on the population in your area and your blood collection system.     When complete, select the X in the upper-right corner to close the window and continue. Run a Normal control in duplicate: With each new lot or shipment of test cartridges received As needed to verify system performance Per your laboratory protocol Download and print a copy of the Donor Quality Control Form. Tips on Running Samples View some tips when running samples. Here are a few tips to keep in mind when running any type of samples on the INNOVANCE® PFA-200 system: All samples (including donor control samples) must be stored at room temperature and are stable for up to 4 hours prior to testing. Make sure test cartridges have reached room temperature before using (approximately 15 minutes). To minimize the risk of trapping an air bubble in the test cartridge, place the tip of the pipette against an inside corner of the opening while you slowly pipette sample into the reservoir. When complete, select the X in the upper-right corner to close the window and continue.    Loading the QC into the Cartridges Learn how to load the QC into the cartridges. Checklist TitleChecklist TypeChecklist ContentOrdering QC SamplesSimulationInstructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90002877/Sim_PFA200_OrderingQC_640x480/Sim_PFA200_OrderingQC_640x480.swfHTML5 File:/content/generator/Course_90002877/Sim_PFA200_OrderingQC_HTML5_700x529/index.htmlPDF File:Loading QC into CartridgesHTML   Select the play arrow to begin the video.  Running TestsHTML After placing the cassette and cartridges onto the carousel, it is time to start the test(s). To run tests, proceed as follows: In the Run Menu screen,  Tap Start.  Canceling Running TestsHTML To cancel running tests, proceed as follows: Stop test: Tap Stop. Tap Yes. Stop changes to … (3 dots). The results and errors associated with the test are stored and printed. If a LIS is connected, the results and errors are transmitted to the LIS. … (3 dots) change to Clear. Clear test: Tap Clear. Information related to the test is cleared from the display. Clear changes to Start. If QC samples have been measured, the sample type changes from QC to Patient and the button Cartridge Lot changes to Patient.   Note: Do not reuse test cartridges of canceled tests. Removing SamplesHTML After the analysis is complete and a closure time is reported, it is time to remove and discard the cartridges. To remove samples, proceed as follows: Wait until the carousel has moved to load position. Remove the cassette carefully from the carousel. Hold the cassette in one hand and gently pull the bottom of the test cartridge toward you until it unsnaps. Discard the test cartridges in a suitable biohazard waste container. Note: Do not reuse test cartridges.  They are designed for one time use only. WARNING:  Infection by infectious samples.  Death or serious illness may result. Avoid contact with samples. Wear appropriate protective equipment. Handle the samples in accordance with good laboratory practices. When complete, select the X in the upper-right corner to close the window and continue. Congratulations. You have completed the INNOVANCE® PFA-200 Quality Control 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.  Demonstrate how to perform a Self Test A self test should be performed: At the start of each shift that the system is in use After the system initializes and completes power-on diagnostic tests, which occur whenever the instrument is powered OFF and then ON To perform a self test, proceed as follows: When starting the analyzer from cold: Wait until the yellow status message in the status bar disappears. The analyzer has then reached operating temperature. In the Maintenance Menu screen, tap System Check. Tap Self Test. Insert a new vacuum cup into each priming cartridge. Load the priming cartridges in position A and B. Optional: Place a new target paper on top of the vacuum cup in position B. Tap Continue. The self test starts. The current status is displayed. Load a new cleaning pad in the carousel well. Apply 4 to 5 drops of isopropanol to the center of the cleaning pad. With a gloved index finger, tap gently on the cleaning pad 2 to 3 times to help distribute the isopropanol. Tap Continue. Using tweezers, remove the cleaning pad. Discard the cleaning pad in a suitable biohazard waste container. Tap Continue. When the self test is finished, a corresponding message is displayed and the maintenance symbol disappears. If printing the results of self tests is activated, the results are printed. Tap Continue. Describe how to establish a normal control donor group Refer to the following guidelines to establish your control donor group: Select potential donors who are free from any medications known to affect platelet function. Test each potential donor by performing two replicates with COL/EPI or COL/ADP cartridges. Qualify a donor if the mean CT result falls within the mean CT ± 25 seconds of the reference range established by your laboratory, and the CV is less than or equal to 15%. Refer to the Quality Control section of the package insert as a guideline. Demonstrate how to run normal control samples Tips for running samples: All samples (including donor control samples) must be stored at room temperature and are stable for up to 4 hours prior to testing. Make sure test cartridges have reached room temperature before using (approximately 15 minutes). To minimize the risk of trapping an air bubble in the test cartridge, place the tip of the pipette against an inside corner of the opening while you slowly pipette sample into the reservoir.   To measure QC samples, proceed as follows: In the Run Menu screen, tap Sample Type. The sample type changes from Patient to QC. The Patient buttonchanges to Cartridge Lot. Sample ID for position A: Tap Sample ID. A keyboard is displayed. Tap the keys required. Verify that the correct sample ID has been entered. Tap the enter key. The sample ID is set. Tap Cartridge Lot. The Cartridge Lot dialog box s displayed, listing the cartridge lots which have already been entered for previous measurements. Select cartridge lot for position A: If the cartridge lot has already been entered for a previous measurement, proceed with the next step, otherwise go to step 9. Tap the arrow buttons to select the cartridge lot. Tap Select. The cartridge lot is set. Enter lot number for position A If the cartridge lot has not yet been entered for a previous measurement: Tap Add Entry. A keyboard is displayed. Tap the keys required. Tap the enter key. The lot number is set. Sample ID and cartridge lot for position B If you want to run a second QC sample, proceed with the next step, otherwise go to step 14. Tap B. The sample type changes back from QC to Patient. The Cartridge Lot button changes back to Patient. Repeat step 1 to step 11 for position B. Perform test: Load the samples Run the tests Remove the samples Describe how to evaluate QC results QC results can be viewed on the following menu screens: Run Menu (current tests only) Result menu (current and previous tests only) QC (graphical display and statistical data)   Use the following criteria to evaluate QC closure time (CT) results: Mean CT falls within established reference range = The system is in control. Mean CT falls outside established reference range = Repeat control using a different donor as control sample from the control donor group. Repeat Mean CT falls within established reference range = The system is in control. The platelet function status and medication history of the individual whose sample was used for the initial testing should be suspected. Repeat Mean CT falls outside established reference range = Contact the Technical Solution Center (TSC) at Siemens.   Select Next to continue. Use the following criteria to evaluate QC closure time (CT) results: Mean CT falls within established reference range = The system is in control. Mean CT falls outside established reference range = Repeat control using a different donor as control sample from the control donor group. Repeat Mean CT falls within established reference range = The system is in control. The platelet function status and medication history of the individual whose sample was used for the initial testing should be suspected. Repeat Mean CT falls outside established reference range = Contact the Technical Solution Center (TSC) at Siemens. Select Next to continue.   To load tubes on the VersaCell X3 system, you need to access the drawer, load the rack carrier with tubes, close the drawer, and then select the appropriate scan option. Once tubes are loaded on the system, the tube barcodes are scanned and the LIS is queried.  The robotic arm then transfers the tubes to the connected instrument so the sample can be aspirated.  The tube is then returned to the drawer. Select the link to learn how to load tubes on the system. Select each tab below to learn how the different menu screens are used to review quality control results. The Result dialog is only available through the Run Menu screen for the current tests. To display the Results dialog for the current test, proceed as follows: In the Run Menu screen, tap A or B to select the required position. Tap Result. The Results dialog is displayed. In the Results dialog, you can: Reprint results Create PDF files of results (if enabled by the Siemens service) View the closure time curve graph (if enabled by the Siemens service) Retransmit results to the LIS (if a LIS is connected   The Result dialog is available through the Result Menu screen for current and previous tests. To display the Results dialog for a specific QC test, proceed as follows: In the Results Menu screen, Tap QC to view the QC sample results Select the sample result you want to view Tap Result. The Results dialog is displayed.  In the dialog Results, you can: Reprint results Create PDF files of results (if enabled by the Siemens service) View the closure time curve graph (if enabled by the Siemens service) Retransmit results to the LIS (if a LIS is connected)   The INNOVANCE® PFA-200 system software allows the review of QC data in graph form. In the QC menu, you can review QC results for a specific lot. The QC Menu is also searchable by lot if you need to review previous lots. The graph displays: Low limit and High limit. (These are set by your laboratory when you configure your INNOVANCE® PFA-200 system.) Mean CV% Standard Deviation When complete, select Next to continue.