PFA-100® Analyzer Quality Control

Welcome to the PFA-100® Analyzer Quality Control Online Training course. Performing quality control on your PFA-100® instrument ensures that the system functions properly as well as reports accurate and precise results.  NOTE: This course does not include audio. Upon successful completion of this course, you will be able to: List the QC tasks Demonstrate how to perform a Self-Test Describe how to establish a normal control donor group Demonstrate how to run normal control samples Describe how to evaluate QC results Congratulations. You have completed the PFA-100® Quality Control Online Training course. Listed below are the key points that have been presented. List PFA-100® QC tasks. PFA-100® QC tasks include: Performing a PFA-100® Self-Test: During the Self-Test, the system performs the O-Ring cleaning procedure, vacuum test, and power-on diagnostic tests. The system then prints the results for your QC records. Perform the Self-Test at least once per shift at the start of each shift that the system is in use. Establish a donor control group: Establish a donor control group so that you have a ready source of donors. Run Control: Run a fresh sample from your control donor group in duplicate following the same procedure that you use to run patient samples. Run controls with each new shipment of cartridges received or whenever your lab needs to verify performance of the system. Demonstrate how to perform a Self-Test. From the Maintenance menu display, select the Self-Test option. Follow the on-screen instructions to prepare the system for the Self-Test by loading a vacuum test cartridge into position A, loading a blue priming cartridge into position B, and loading and then applying isopropanol to the O-Ring cleaning pad. The system prints results as the power-on diagnostic tests, O-Ring cleaning procedure, and vacuum test are completed. Describe how to establish a donor control group. Refer to the following guidelines to establish your control donor group: Select potential donors who are free from medications that affect platelet function. Test each potential donor by performing two replicates using COL/EPI cartridges only. Qualify a donor if the mean CT result falls within the mean CT ± 25 seconds of the reference range established by your laboratory, and if the CV is less than or equal to 15%. Demonstrate how to run normal control samples. To run normal controls, load two COL/EPI test cartridges into positions A and B of the cassette. Pipette 800 µL of sample into each cartridge, and then load the cassette. From the Menu display, select Run Control. Enter the control lot number and ID, and then press the softkey located next to Run. Describe how to evaluate control results. Use the following criteria to evaluate the control results: If the mean CT falls within the established reference range: The system is in control. If the mean CT falls outside the established reference range: Repeat control using a new sample from the control donor group. If a repeat mean CT falls within the 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 control run should be suspected. If a repeat mean CT falls outside the established reference range: Contact the Technical Assistance Center (TAC). Ensure that your PFA-100® instrument reports accurate and precise results by performing the following quality control tasks:   Perform a QC Self-Test Establish a donor control group Run Control During the Self-Test, the system performs the O-Ring cleaning procedure and a vacuum test in addition to the power-on diagnostic tests. The system then prints the results for your QC records. Perform the Self-Test at least once per shift at the start of each shift that the system is in use.  PFA-100® tests require fresh normal samples to evaluate platelet function. This means that you need to obtain fresh samples each time you need to run a control. Establish a donor control group so that you have a ready source of donors whose CT results fall within your laboratory’s established normal reference range. Run a fresh sample from your control donor group using the same procedure that you use to run patient samples. Evaluate the closure time results against your established reference ranges. It is recommended to run controls in duplicate with each new shipment of cartridges received or whenever your lab needs to verify performance of the system. Perform a QC Self-Test to verify proper performance of the PFA-100® instrument. During the Self-Test, the system performs the O-Ring cleaning procedure and a vacuum test, and then prints the results for your QC records. When should you perform a QC Self-Test? 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 QC Self-Test Learn about QC Self-Tests. Checklist TitleChecklist TypeChecklist ContentSample ChecklistHTML From the System Ready display, press the softkey located next to Menus. Select MaintenanceHTML From the Menu display, press 2 on the keypad to select the Maintenance option. Select Self-TestHTML From the Maintenance menu display, press 2 on the keypad to select the Self-Test option. Then press the softkey next to Yes to continue the Self-Test. Insert Vacuum Test CupHTML Insert a vacuum test cup into a blue priming cartridge to create a vacuum test cartridge. Place the vacuum test cartridge into position A of the cassette. Load Priming CartridgeHTML Load a blue priming cartridge with on vacuum test cup in position B of the cartridge. Load O-Ring Cleaning PadHTML The system then rotates the carousel. Apply 4-5 drops of isopropanol to the center of the O-Ring cleaning pad (circular foam sponge). Press gently on the pad with a globed index finger 2-3 times to distribute the isopropanol. Insert the cleaning pad in the well. Select ContinueHTML Press the softkey located next to Continue. Test in ProgressHTML During this phase, various screens appear that describe the progress of the Self-test, which takes approximately seven minutes for the system to complete. The system will perform a Vacuum Leak Test and O-Ring cleaning procedure in addition to performing Power On Diagnostic tests with the exception of the Memory Test. Check ResultsHTML As each test is completed the system prints pass/fail results as well as high/low flag ranges for each test type. If a problem is detected, an error message will be displayed and printed, and the system will prevent the running of a test. Remove ConsumablesHTML Toward the end of the Self-Test, the system prompts you to remove the O-Ring cleaning pad, vacuum test cartridge and blue priming cartridge from the cassette. You can rinse and reuse the blue priming cartridges for future use. Next, press the softkey located next to Continue. Return to System Ready DisplayHTML When the Self-Test is completed, the Maintenance menu display reappears. Press the soft key next to Previous Screen twice to return to the System Ready display. The System Ready display indicates you are now ready to run controls and patient samples. Click the links to view or print a PDF version of the job aids that will help you perform QC tasks. Donor Control Group Form QC & Maintenance Form Use the following criteria to evaluate QC closure time (CT) results:   QC Result Interpretation 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 Assistance Center (TAC) To run a normal control, use a fresh sample from your control donor group. Then, run the test just as you run patient samples. Note the following: Run a normal control in duplicate with each new shipment of test cartridges received, or whenever your lab needs to verify PFA-100® performance of the system. Record your control results. Refer to the QC & Maintenance Form job aid. Here are tips when running control samples: 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.  Run Normal Controls Learn about running normal controls. Checklist TitleChecklist TypeChecklist ContentLoad Test CartridgesHTML To run controls, first load two COL/EPI test cartridges into positions A and B of the cassette. Pipette SampleHTML Resuspend the whole blood control sample by gently inverting the collection tube 3-4 times by hand and then pipette 800 uL of sample into the sample reservoir opening of the test cartridge. Insert CassetteHTML Insert the cassette into the carousel to load the cartridges into the instrument. Select MenuHTML To open the Menu display, press the softkey located next to Menus. Select Run ControlHTML To select Run Control from the Menu display, press 1 on the keypad. Enter Lot NumberHTML To enter the test cartridge lot number, press the number on the keypad. Then press the softkey next to Enter. Enter Control Sample IDHTML To enter the control sample ID, use the keypad. Select RunHTML To start the run, press the softkey located next to Run. The system will assign the same control sample ID to both cartridges. Controls ProcessHTML Various screens appear while controls in positions A and B are being processed. The System Ready display reappears. Print ResultsHTML When test is complete, the instrument prints out and displays the CT results, VC% and mean, if tests were run in duplicate. The printout also will display the test cartridge type, lot number and control ID as well as status messages, if the system detected any events or conditions during the analysis. Print Stored Control Results Learn how to print stored control results. To print control results: Press Menu from the System Ready display and then select the Print Log option #4. From the Print Log display, select the Control Results option #2. Use the numeric keypad to enter the number of control results to be printed, and then press the softkey located next to Enter. The system will print the number of results entered, starting with the most recent control performed. Because of the fragile nature of platelets in whole blood, there is no “off the shelf” QC product available for use on the PFA-100®. This means that each laboratory needs to establish a pool of qualified donors to be used as control samples. This protocol will also ensure that you are using the same population of donor samples that were used to establish your PFA-100® reference range for normal closure times (CTs). 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. For example, if the mean CT of your reference range is 120 seconds, the range for qualifying donors for the control group would be 95 to 145 seconds. Establishing Reference Ranges Learn 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 PFA-100® test cartridges as a general guideline to determine if donors qualify for inclusion in a donor pool. In a limited study on 36 apparently normal subjects, up to 12% shorter closure times were observed for samples collected in 3.2% buffered sodium citrate. 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 But you should eventually establish your own quality control reference range based on the population in your area and your blood collection system. For example, for one U.S. study, a group of 176 normal subjects consisting of 61% females and 39% males between 18 and 57 years of age was tested. The mean CT ± 25 seconds was then calculated to establish a quality control reference range of 110-160 seconds (samples collected in 3.8% buffered sodium citrate).