PEPconnect

Quality Control Procedures for the MAMMOMAT Revelation

This web based course provides an overview of the Quality Control or QC Procedures for the MAMMOMAT Revelation Mammography system. These processes are necessary to ensure the safe and proper operation of this system.
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  • This CE activity may be available in multiple formats or from different CE sponsors. ARRT regulations state that an individual may not repeat a CE activity for credit if it was reported in the same CE biennium.

By the end of this course you will be able to: • Define what quality control is and why it is important     • Properly perform the start up and shut down procedures • Define the frequency for each of the quality control tests • Correctly perform and analyze quality control procedures on the MAMMOMAT Revelation with Tomo • Explain the importance of each quality control test • Define corrective action for each of the quality control tests Quality Control Procedures for the MAMMOMAT Revelation   Quality Control is... "a series of distinct technical procedures that ensure the production of a satisfactory product."   (1999 ACR Mammography Quality Control Manual)  Detect Identify Correct ...equipment related problems before they have a damaging effect on clinical images. Test Frequency Phantom Imaging Quality (ACR) Weekly Artifact Detection Weekly SNR and CNR Measurements Weekly Repeat/Reject Analysis Quarterly Detector Calibration  Quarterly  Compression Force  Semi-Annually Printer Check Continuous use - daily test Sporadic use - prior to use on the same day Test Frequency Phantom Imaging Quality (ACR) Weekly Artifact Detection Weekly SNR and CNR Measurements Weekly Repeat/Reject Analysis Quarterly Detector Calibration  Quarterly  Compression Force  Semi-Annually Printer Check Continuous use - daily test Sporadic use - prior to use on the same day Test Frequency Phantom Imaging Quality (ACR) Weekly Artifact Detection Weekly SNR and CNR Measurements Weekly Repeat/Reject Analysis Quarterly Detector Calibration  Quarterly  Compression Force  Semi-Annually Printer Check Continuous use - daily test Sporadic use - prior to use on the same day Test Frequency Phantom Imaging Quality (ACR) Weekly Artifact Detection Weekly SNR and CNR Measurements Weekly Repeat/Reject Analysis Quarterly Detector Calibration  Quarterly  Compression Force  Semi-Annually Printer Check Continuous use - daily test Sporadic use - prior to use on the same day Temperature recommendations for the MAMMOMAT Revelation mammography room: +20° - 30° C or 68° - 86° F • Monitor room and detector temperature  • Monitor the room with a small digital thermometer • Heat or cool the room at night and on weekends • If room temperature changes +/- 7º Celsius (12º F) = Warning icon Let the MAMMOMAT Revelation warm up for at least 15 minutes to ensure optimum results when performing an image quality test. Exception: SNR and CNR tests (Test 3 and Test 7):  minimum 1 hour after start up ...or select the End Examination button Test Frequency Artifact Detection Weekly SNR and CNR Measurements Weekly Phantom Imaging Quality (ACR)  Weekly Repeat/Reject Analysis Quarterly Compression Force Semi-Annually Detector Calibration Quarterly Test Frequency Artifact Detection  Weekly SNR and CNR Measurements Weekly Phantom Imaging Quality (ACR) Weekly Repeat/Reject Analysis Quarterly Compression Force Semi-Annually Detector Calibration Quarterly • AEC • 28 kVp • Tungsten Target Filter Acceptable Unacceptable Performance Criteria and Corrective Action No clinically relevant artifacts shall be seen on the image.  If the test results fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken within thirty days of the test date. If the source of the problem is a major component, the medical physicist must evaluate the equipment. The requirements pertaining to the evaluation are described in FDA regulations and in subsequently issued guidance. The issue should be addressed and documented by a Siemens Customer Support.   • AEC • 28 kVp • Tungsten Target Filter SNR Analysis CNR Analysis Deviations for SNR & CNR Performance Criteria and Corrective Action The SNR must be ≥40.  The CNR must be ≥2. The SNR and CNR must not differ by more than ±15% of the baseline values that the medical physicist determined during the Mammography Equipment Evaluation (MEE) which is required during installation. If the test results fall outside of the allowed tolerance, the source of the problem shall be identified and corrective actions shall be taken within thirty days of the test date. If the source of the problem is a major component, the medical physicist must evaluate the equipment. The requirements pertaining to the evaluation are described in FDA regulations and in subsequently issued guidance. The issue should be addressed and documented by Siemens Customer Support.   • AEC • 28 kVp • Tungsten Target Filter ACR (RMI 156) Phantom (1) Fibers (2) Speck groups (3) Masses Number of objects that need to be visible: • Fibers > 5 • Speck groups > 4 • Massess > 4 Performance Criteria and Corrective Action If the test results fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken before any further mammographic images are acquired using the image acquisition system. If the source of the problem is a major component, the medical physicist must evaluate the equipment. The requirements pertaining to the evaluation are described in FDA regulations and in subsequently issued guidance. The issue should be addressed and documented by Siemens Customer Support.   ACR Phantom (RMI 156) (1) Fibers (2) Speck groups (3) Masses Number of objects that need to be visible: • Fibers > 4 • Speck groups > 3 • Massess > 3 Inform Siemens Customer Service for corrective Action if the below requirements are not visible: QC Images Retention Daily QC Previous 30 days Weekly QC Previous 12 weeks Monthly QC Until the next annual inspection has been completed and the FDA has determined that the facility is in compliance with the quality assurance requirements. Quarterly QC Until the next annual inspection has been completed and the FDA has determined that the facility is in compliance with the quality assurance requirements. Semi-annual QC Tests Until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed 2 additional times at the required frequency, whichever is longer. Annual QC Tests Not required by FDA; the ACR recommends that images documenting test failures be provided to the facility to assist them in making corrective actions. Mammography Equipment Evaluations Not required by FDA; the ACR recommends that images documenting test failures be provided to the facility to assist them in making corrective actions. Test Frequency Phantom Imaging Quality (ACR) Weekly Artifact Detection Weekly SNR and CNR Measurements Weekly Detector Calibration Quarterly Repeat/Reject Analysis  Quarterly Compression Force Semi-Annually Test Frequency Phantom Imaging Quality (ACR) Weekly Artifact Detection Weekly SNR and CNR Measurements Weekly Detector Calibration Quarterly Repeat/Reject Analysis Quarterly Compression Force Semi-Annually Once calibration begins, the subtask card will update to reflect the type selected, such as Contact, Magnification, or Tomo. Appropriate for Calibration Inappropriate for Calibration Performance Criteria and Corrective Action If the percentage of rejected/repeated images changes by more than 2% when compared to the previous test, the reason(s) for the change shall be investigated. Corrective action is completed once an explanation for the change has been determined and, if indicated, an action plan has been implemented.   QC Images Retention Daily QC Previous 30 days Weekly QC Previous 12 weeks Monthly QC Until the next annual inspection has been completed and the FDA has determined that the facility is in compliance with the quality assurance requirements. Quarterly QC Until the next annual inspection has been completed and the FDA has determined that the facility is in compliance with the quality assurance requirements. Semi-annual QC Tests Until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed 2 additional times at the required frequency, whichever is longer. Annual QC Tests Not required by FDA; the ACR recommends that images documenting test failures be provided to the facility to assist them in making corrective actions. Mammography Equipment Evaluations Not required by FDA; the ACR recommends that images documenting test failures be provided to the facility to assist them in making corrective actions. Test Frequency Phantom Imaging Quality (ACR) Weekly Artifact Detection Weekly SNR and CNR Measurements Weekly Repeat/Reject Analysis Quarterly Detector Calibration Quarterly Compression Force Semi-Annually Test Frequency Phantom Imaging Quality (ACR) Weekly Artifact Detection Weekly SNR and CNR Measurements Weekly Repeat/Reject Analysis Quarterly Detector Calibration Quarterly Compression Force Semi-Annually Performance Criteria and Corrective Action Check that the applied force is between 120 N and 200 N (25 - 45 pounds) on the stand. Check that the force is maintained for one minute within ±20 N. If the test results fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken before any further mammographic images are acquired using the image acquisition system. If the source of the problem is a major component, the medical physicist must evaluate the equipment. The requirements pertaining to the evaluation are described in FDA regulations and in subsequently issued guidance. The issue should be addressed and documented by Siemens Customer Support.   You have now completed the course Quality Control Procedures for the MAMMOMAT Revelation.  You should now be able to: • Define what quality control is and why it is important     • Properly perform the start up and shut down procedures • Define the frequency for each of the quality control tests • Correctly perform and analyze quality control procedures on the MAMMOMAT Revelation with Tomo • Explain the importance of each quality control test • Define corrective action for each of the quality control tests

  • MAMMOMAT
  • Revelation
  • quality control
  • tests
  • mammography
  • ARC
  • QC