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Evaluating FFDM System QC Records

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Evaluating FFDM System QC Records

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    1. Evaluating FFDM System QC Records W. G. Mourad, Ph.D. DMQRP/OCER/CDRH/FDA 5/21/05

    2. Objective To provide guidance to MQSA inspectors regarding the evaluation of Quality Control (QC) procedures at facilities that use FDA-approved Full Field Digital Mammography (FFDM) systems on patients.

    3. FFDM Systems Approved by FDA for Clinical Use The 2000D was first approved for hc only. It was later (11/20/00) for sc. The DS was approved by a 510K process. ACR’s ph. #: 800-227-6440. SIA ph. #: 515-725-0314. STX ph. #: 512-834-6688. The 2000D was first approved for hc only. It was later (11/20/00) for sc. The DS was approved by a 510K process. ACR’s ph. #: 800-227-6440. SIA ph. #: 515-725-0314. STX ph. #: 512-834-6688.

    4. FFDM Systems Approved by FDA for Clinical Use – cont’d To date, these are the only FFDM systems approved by FDA for marketing. FDA-approved FFDM systems are subject to MQSA inspections under the final regulations. All FDA-approved FFDM systems use the same S-F mammography accreditation phantom for their weekly phantom IQ test. Guidance presented here applies only to these systems.

    5. FDA-Approved FFDMs without an AB May not be used clinically without written approval from FDA’s Division of Mammography Quality and Radiation Programs (DMQRP). DMQRP developed an interim procedure for such units until it approves AB standards for them. Facilities must apply to DMQRP for extending their certification to include the new FFDM units.

    6. FDA-Approved FFDMs with no AB – cont’d DMQRP sends a letter describing: The steps a facility must take. Personnel and quality control requirements for FFDM. If DMQRP approves the application, it sends the facility a letter allowing clinical use. Once approved for clinical use, facilities must follow the QC procedures recommended by the FFDM unit manufacturer.

    7. FFDM System QC Manuals - General Facilities & medical physicists (MP’s) should use the latest applicable QC manual. Inspectors will use the QC manual the facility had in a given time period to evaluate compliance during that period. If the facility/MP uses an earlier QC manual after an updated version became available, the facility could be cited. If the facility had not yet acquired an updated version, it should not be cited. continuing use of an outdated manual after acquiring a new one, could be citable.

    8. Current Evaluation Procedures Select a unit from a list If an FFDM unit: Check the image display method (s) used: Monitor (softcopy) Laser Film (hardcopy) Other Review the 8 hours FFDM training records Review FFDM QC records – other screens blocked Review applicable reports of the annual survey & the MEE but do not answer test-specific questions.

    9. Current FFDM-Related Questions Manufacturer recommended QC procedures followed? (always accessible) Monitor QC done per manufacturer’s recommendation? (“Monitor” checked) Manufacturer recommended procedures used? (“Laser Film”/“Other” checked) Citations based on these questions - implemented 2/15/03 All are “yes/no” questions New modality training* [8 hours] (y/n/NA) * [question appears in all personnel screens. Citations implemented since 2000].

    10. Answering FFDM QC-Related Questions Review the QC records & determine if the facility: 1. Conducted the QC tests (annual and others) as recommended by the FFDM unit manufacturer 2. Took & documented timely corrective action(s) (C/A) for the tests that failed. If items 1 & 2 above have been successfully completed, answer “yes” to all accessible QC questions. If either item 1 or item 2 is incomplete, answer “no” to the first QC question then answer the other two questions accordingly.

    11. Answering FFDM QC-Related Questions – cont’d FFDM QC Test Records GE Fischer Hologic/Lorad Siemens

    12. GE Quality Control (QC) Manuals * Manual used in current guidance.* Manual used in current guidance.

    13. The GE FFDM Systems/Sub-Systems The GE Senographe 2000D – 1st. FDA-approved system The Seno Advantage (display system) – stand alone upgrade for the Senographe 2000D display system (10/03). The Seno Advantage/Senographe DS combo - marketed as an upgrade on the Senographe 2000D (2/04). The GE QAP Manuals – all versions: Radiologic Technologist (RT) QC Tests - Non annual MP QC Tests – Annual survey & MEE (as applicable) Guidance (RT & MP) The GE FFDM-related QC tests listed here are based on the manuals with an asterisk (*) in the previous slide

    14. GE FFDM Systems/Sub-systems – Approved Amended Alternative Standard (AS) Timing of Corrective Actions (C/A) - GE FFDM Systems Originally: All FFDM C/A’s must be completed before using the failing item clinically June 02: FDA approved an AS for the 2000D Aug. 03: Amended AS – separate acquisition and display How Long? Indefinite Applicability: GE FFDM systems only Different C/A time limits (& scopes) The Image Acquisition System The Image Display System

    15. The GE FFDM Systems/Sub-systems – Amended AS Timing of Corrective Actions in the GE FFDM Acquisition System Group 1: before using the failing item(s) to acquire any clinical images Group 2: before using the failing item(s) to print or process any clinical images Group 3: 30 days

    16. Amended AS – Timing of C/A in the GE FFDM Acquisition System Group 1 - Before acquiring clinical images (1) Monitor cleaning for the acquisition work station (AWS) (2) Flat Field Test (3) CNR Test (4) Phantom Image Quality Test for the AWS (5) MTF Measurement (6) AOP Mode and SNR Check (7) Visual Check List (8) Compression Force Test (9) Average Glandular Dose (10) Post-move, Pre-examination Tests for a mobile FDA-approved GE FFDM

    17. Amended AS – Timing of C/A in the GE FFDM Acquisition System – cont’d Group 2 - Before printing/processing clinical images (1) Phantom Image Quality Test for the Printer (2) Viewbox and Viewing Conditions Test (3) Printer QC

    18. Amended AS – Timing of C/A in the GE FFDM Acquisition System – cont’d Group 3 - 30 days (1) Repeat Analysis (2) Collimation Assessment (3) Evaluation of Focal Spot Performance (4) Exposure and mAs Reproducibility (5) Artifact Evaluation; Flat Field Uniformity (6) kVp Accuracy and Reproducibility (7) Beam Quality Assessment (Half-Value Layer Measurement) (8) Radiation Output (9) Mammographic Unit Assembly Evaluation

    19. The GE FFDM Systems/Sub-systems – Amended AS Timing of Corrective Actions in the GE FFDM Display System Group 1: before using the failing item(s) to print or process any clinical images Group 2: 30 days

    20. Amended AS – Timing of C/A in the GE FFDM Display System Group 1: Before processing or printing clinical images (1) Monitor cleaning for the review workstation (RWS) (2) Viewing Conditions for the RWS (RT’s test) (3) Viewing Conditions Check and Setting (MP’s test - RWS) (4) Phantom Image Quality Test for the RWS (5) Phantom Image Quality Test for the Printer (6) Viewbox and Viewing Conditions Test (7) Monitor Calibration Check (RT’s test - RWS) (8) Image Quality—SMPTE Pattern (MP's test - RWS) (9) Printer QC

    21. Amended AS – Timing of C/A in the GE FFDM Display System Group 2: 30 days (1) Monitor Calibration (MP test for the RWS) (2) Analysis of the RWS Screen Uniformity.

    22. GE – Table Footnotes - applicable to all QC tests (*): When clinical image acquisitions or reviews are planned (**): Performance verification test (mobile) (***): Either 26 kVp & 125 mAs (GE recommendation) or technique factors for the Standard Breast A: C/A required before acquiring clinical images B: C/A required before printing/processing, reviewing or interpreting clinical images C: C/A required within 30 days of the test date

    23. RT QC Tests - GE

    24. RT QC Tests – GE – cont’d

    25. RT QC Tests – GE – cont’d

    26. MP QC Tests - GE

    27. MP QC Tests – GE – cont’d

    28. MP QC Tests – GE – cont’d

    29. MP QC Tests – GE – cont’d

    30. Fischer SenoScan QC Manuals

    31. Fischer SenoScan QC Manuals QC tests in the Tables to follow are based on the FFDM 94001G-3, Issue 1, Rev. 4 manual. Subsequent manuals list the same tests but mostly in different sections and or pages This manual has 6 sections & 3 Appendices QC procedures for both the technologist & medical physicist are in Section 5.

    32. The Fischer SenoScan System Note: According to all Fischer SenoScan QC manuals (which can be more restrictive than MQSA) issued to date: If any of the SenoScan-related tests listed in the following tables fail, the facility must identify the problem and take corrective action before further exams are performed.

    33. RT QC Tests - Fischer SenoScan

    34. MP QC Tests - Fischer SenoScan

    35. MP QC Tests - Fischer SenoScan – cont’d

    36. Quality Control (QC) Manuals – Hologic/Lorad

    37. The Lorad Selenia QC Manuals QC tests in the Tables to follow are based on the Selenia FFDM System QC Manual # MAN-00042-Rev001/003. Subsequent manuals list the same tests but mostly in different sections and or pages The manual contains: Introduction Required QC Tests (Technologist & MP) Guidance for the QC tests QC test forms - Technologist QC test forms - MP Note: Since the Lorad LDBI was never used clinically, its QC tests will not be discussed

    38. Approved AS- Timing of Corrective Actions in the Lorad Selenia Approved: 8/03 How Long? Indefinite Applicability: Lorad Selenia FFDM systems 30 day C/A for QC tests equivalent to S-F QC tests where 30 day C/A period is allowed QC tests requiring C/A divide into 3 groups: Group A: Before the failing component is used again for image acquisition Group B: Before the failing component is used again for image display, printing/processing, or reading Group C: 30 days

    39. Approved AS - Lorad Selenia Group A (1) Evaluation of System Resolution (2) Breast Entrance Exposure and Average Glandular Dose (3) Phantom Image Quality Evaluation (MP) (4) Phantom Image (RT) (5) Signal-to-Noise and Contrast-to-Noise Measurements (6) Detector Flat-Field Calibration (7) Compression (8) Post-Move and Pre-Examination Tests for Mobile Selenia™ FFDM systems

    40. Approved AS - Lorad Selenia Group B (1) Phantom Image Quality Evaluation (MP) (2) Phantom Image (RT) (3) Softcopy Workstation QC (4) Laser Printer Quality Control (5) Dark Room Cleanliness (6) Processor Quality Control (7) Viewboxes and Viewing Conditions (8) Darkroom Fog

    41. Approved AS - Lorad Selenia Group C (1) Mammographic Unit Assembly Evaluation (2) Collimation Assessment (3) Artifact Evaluation (4) kVp Accuracy and Reproducibility (5) Beam Quality Assessment – HVL Measurement (6) Radiation Output Rate (7) Viewbox Luminance and Room Illuminance (8) Compression Thickness Indicator (9) Visual Checklist (10) Analysis of Fixer Retention in Film (11) Repeat Analysis

    42. RT QC Tests - Lorad Selenia (*) Per facility protocol in Rev 003 For the laser printer: MD: 40% patch DD: density of 40% patch – density of 10% patch LD: 90% patch(*) Per facility protocol in Rev 003 For the laser printer: MD: 40% patch DD: density of 40% patch – density of 10% patch LD: 90% patch

    43. RT QC Tests - Lorad Selenia

    44. MP QC Tests - Lorad Selenia

    45. MP QC Tests - Lorad Selenia Since AEC functionality has not been implemented, manual mode with technique factors of 28 kVp, 65 mAs, & Mo/Mo for Phantom, Dose, SNR & CNR.Since AEC functionality has not been implemented, manual mode with technique factors of 28 kVp, 65 mAs, & Mo/Mo for Phantom, Dose, SNR & CNR.

    46. Quality Control (QC) Manuals – Siemens

    47. Siemens MAMMOMAT NovationDR QC Manuals QC tests in the Tables to follow are based on: The Siemens MAMMOMAT NovationDR FFDM QC manual # P030010/A13/C2V, and The Softcopy Workstation QC Manual MammoReportPlus QC tests for the technologist & the MP are listed in both manuals Some QC tests in the Softcopy Workstation QC Manual may also be performed by the Customer Support Engineer (CSE)

    48. Siemens MAMMOMAT NovationDR QC Manuals Note: According to the Siemens MAMMOMAT NovationDR FFDM QC manuals (which can be more restrictive than MQSA) issued to date: If any of the MAMMOMAT NovationDR-related tests listed in the following tables fail, the facility must identify the problem and take corrective action before further exams are performed.

    49. RT QC Tests – Siemens MAMMOMAT NovationDR System (SC workstation & unit)

    50. MP/CSE QC Tests - Siemens SC Workstation (MammoReportPlus QC Manual) The appropriate TG-18 pattern is used in most testsThe appropriate TG-18 pattern is used in most tests

    51. MP QC Tests – Siemens MAMMOMAT NovationDR

    52. MP QC Tests – Siemens MAMMOMAT NovationDR

    53. MPs’ Dose Data in FFDM Units – 6/00-9/03 Reported in the initial MEE w/application to use clinically # of Facilities: 264 # of Units Approved: 337 # of Units in the Dose Data Analyzed 318 Units Included: GE 2000D Fischer SenoScan Lorad Selenia

    54. MPs’ Dose Data in FFDM Units – 6/00-9/03 Maximum Dose: 298 mrad Minimum Dose: 57 mrad Average Dose: 151.8 mrad Standard Deviation: 36.5 mrad Coefficient of Variation: 0.23

    55. MPs’ Dose Data in FFDM Units – 6/00-9/03

    56. Recent FFDM Inspection Results As of 4/1/05: # of Certified FFDM Facilities/Units: 607/819 Inspection Data: 2/23/01 – 3/22/05 # of Facilities/Units (inspected at least once) 423/556 # not using hardcopy interpretation 117 # not using softcopy interpretation 15 # of All Inspections 635

    57. Recent FFDM Inspection Results # of All Inspections 635 # ‘01 inspections 2 # ‘02 inspections 9 # ‘03 inspections (2/20 – 12/31) 146 # ‘04 inspections (1/1-12/31) 376 # ‘05 inspections (up to 3/22/05) 102 Up to 3/22/05: one facility had 5 inspections a few had 4 inspections some had 3 inspections a sizable number had 2 inspections.

    58. Recent FFDM Inspection Results Facility Citations FFDM QC Q1- Manufacturer recommended. QC followed? 13 Q2- Monitor QC per mf’r. recommendations done? 5 Q3: Mf’r. recommended (laser film/other) QC followed? 2 Citation Time Frame: 2/15/03 – 3/22/05 8 Hours New Modality Training Interpreting Physicians: 17 Radiologic Technologists: 7 Medical Physicist: 1 Citation Time Frame: ~ 1/01 – 3/22/05

    59. Proposed Additions to FFDM-Related Inspection Questions Record the following data – Cite if the facility did not take C/A where needed, or if data is outside the action levels: Dose Measured by M. P. (mR) ---- CNR (GE, Lorad, Siemens) baseline value ---- ADU Level Difference (Fischer) baseline value ---- SNR (GE, Lorad, Siemens) ---- Bkgd Mean & Bkgd RMS (Fischer) ----

    60. Proposed Additions to FFDM-Related Inspection Questions MEE for units or processors/printers Cite if not conducted (where needed) Annual Survey Report - Cite if: The most recent survey is over 14 months old The time span between the current & previous surveys is > 14 months Both the current and previous surveys were not conducted The M.P. conducting/supervising the survey is not identified in the report

    61. Proposed Additions to FFDM-Related Inspection Questions Phantom Image Ask the technologist to take two phantom images using clinical techniques for the standard breast and, optimize the display monitor for scoring Score as in S-F mammography and record results Citation levels will be the same as in S-F systems

    62. For More Information: Internet home page: http://www.fda.gov/cdrh/mammography/ MQSA Facility Hotline Web Address MQSAhotline@SSSI.net Phone 800/838-7715 Fax 410/290-6351

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