Update on ACR Digital Mammography QC Manual - FLAAPM

47 Pages·2015·6.31 MB·English

4/28/2015
Update on ACR Digital
Mammography QC Manual
Priscilla F. Butler, M.S.
Medical Physicist and Senior Director,
ACR, Reston, VA
(with thanks to Eric Berns, Ph.D.)
Overview
• Phantom Specifications
• QC Manual
• Explain what we feel is important
• Thank you for being here today
1
4/28/2015
Digital Mammography in the US
(as of 3/1/15)
• 13,493
units at
8720
facilities
• Over 96%
of all
units in
US are
FFDM
*4 accrediting bodies
*Over 30 models and
mfrsapproved by
FDA
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Quality Control: What It and Why Is It
Important?
Primary Purpose
• Reduce exposure to patients and personnel
• Ensure adequate and consistent patient image
quality
• Detect and correct for potential problems, before
they impact patient image quality and care
What it’s not:
• Not a detailed technical evaluation of a unit
• Not a detailed measure of a limits of a unit
• Not the optimization of a unit
QC Mandates
• MQSA
– Mammography Quality Standards Act
• ACR
– American College of
Radiology
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FDA’s Current DM QC Requirements
• Follow latest version of mfr’s QC manual
procedures for unit tested
– Lorad (Hologic) allows facility to follow any of their
manuals
• Meet mfr’s performance standards
• Failures must be fixed before use on patients
– Most mfrs applied for alternative standards to
allow 30 days for some QC tests
ACR’s Current DM QC Requirements
• Same as FDA’s
• Which are the same as the manufacturer’s
• ACR suggests using manufacturer’s data forms
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Screen-Film QC
• Single detector
technology
• Single processing
technology
• First QC manual in
1990
Manufacturer’s DM QC Requirements
• Tests vary for each manufacturer and model
– Some tests same but names different
– Some tests not required by some manufacturers
• Frequencies vary for each manufacturer and
model
• Procedures vary for each manufacturer and
model
• Pass/fail criteria vary for each manufacturer and
model
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Film Printers
• FDA recommends only using printers
cleared by FDA’s Office of Device
Evaluation for FFDM (but may legally use
others)
• Facility must have access to a laser printer
(either on-site or someplace else)
• Printer must exist and be tested by MP
before the facility performs mammography
Monitors and Workstations
• FDA regs require facilities to comply with a QA
program substantially the same as that of FFDM mfr
(i.e., GE, Lorad, etc.)
– Impractical; even impossible since tests are software-
based
• FDA says
– If the monitor/workstation has been cleared by FDA’s ODE
for FFDM, the monitor’s QC manual is “substantially the
same” and OK to follow
– If monitor was not cleared by FDA ODE for FFDM facilities
must follow one by FFDM mfr
• FDA ODE clears monitors/workstations
– Over 500 total; ? have been cleared for FFDM
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ACR DM QC Manual
VS.
All of the above may vary
with QC manual
revisions of same
manufacturer/model
ACR DM QC Manual Project
• Subcommittee on Quality Assurance
– Chair – Eric Berns, PhD – University of Colorado
• Subcommittee – all volunteers (with day
jobs)
– Clinical representatives
– MITA representatives (equipment and phantom
manufacturers)
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4/28/2015
ACR DM QC Manual Project
• Subcommittee Charge:
– Design ACR Accreditation Phantom for FFDM
– Write QC Manual for ACR FFDM Mammography
Accreditation Program
• Subcommittee Goals:
– Standardize all QC tests for all digital manufacturers
– Standardize test frequencies
– Standardize performance criteria
ACR DM QC Manual Project
• QC tests:
– Will apply to all manufacturers
– Tests come from a variety of sources (MQSA, SFM,
ACRIN DMIST, Manufacturer’s QC programs, MITA,
subcommittee clinical experience, etc.)
– Clinically relevant
– User friendly
– Eliminate non-productive testing
• Just because you can test something, doesn’t
mean you should!
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ACR Digital QC Manual - Structure
• Radiologist’s Section
• Radiologic Technologist’s Section
• Medical Physicist’s Section
• Appendices
• **Clinical Image Quality Section (w/Patient
Positioning and Compression and Clinical
Image Quality Evaluation) will be revised at a
later date and posted on ACR website
ACR Digital QC Manual - Tools
• Will be downloadable to computer or tablet
• Future revisions fully described (in new
“Revisions” section)
• Sections and references fully linked
• Optional procedures and forms available
• Management forms available to aid organization
• Procedures liberally illustrated
• Forms in PDF and Excel formats
– Excel formats contain formula and functionality
– Excel forms downloadable from ACR website
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ACR DM QC Manual Project
• Subcommittee Goals:
– Standardize all QC tests for all digital Mfrs
– Standardize test frequencies
– Standardize performance criteria
What Will Be New?
10