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Evaluating FFDM System QC Records

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

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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

  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 • continuing use of an outdated manual after acquiring a new one, could be citable.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

  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

  43. RT QC Tests - Lorad Selenia

  44. MP QC Tests - Lorad Selenia

  45. MP QC Tests - Lorad Selenia

  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 NovationDRFFDM 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 NovationDRFFDM 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)

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