Mammography Accreditation and MQSA Certification

1
Mammography Accreditation and MQSA
Certification
2
Introduction
3
History

• 1987 ACRs voluntary Mammo Accreditation
  Program
• 1992 President Bush signs the Mammography
  Quality Standards Act
• 1994 FDAs Interim Rules requires all mammo
  facilities in the US to be accredited, certified
  and inspected QC regs mirror the ACR
  requirements
• 1999 FDAs Final Rules went into effect with
  new detailed requirements, including direct
  patient notification

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Why ACR Accreditation?

• Validation of quality
• Peer process
• Judy Destouet, M.D. current chair, Committee on
  Mammography Accreditation
• Educational process
• MQSA requires accreditation for all mammo
  facilities (screening and diagnostic)
• Patient confidence
• Facilities meet the highest standards of their
  profession

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How Can ACR Accreditation Help You and Your
Practice?

• ACR coordinates members review and comment of
  proposed FDA regs and guidance
• Sent to FDA from ACR, a professional society of
  over 30,000
• Practice support materials develop by
  radiologists, medical physicists and
  technologists
• Mammography QC Manual, BI-RADS, Standards
• Many other resources

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Study Guide
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1. We just moved one of our 2 accredited
mammography units to our new free-standing
clinic. After my physicist does her Equipment
Evaluation survey and everything passes, we can
use it to examine patients.
TRUE or FALSE
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Facility Requirements Under MQSA
DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and
Drug Administration21 CFR Part 900Quality
Mammography Standards AGENCY Food and Drug
Administration, HHS. ACTION Final ruleAs
Amended by Federal Register Notice 10/22/98,
4/15/99, 6/17/99 DATES This regulation is
effective April 28, 1999 except Sec.
900.12(b)(8)(i), (e)(4)(iii)(B),(e)(5)(i)(B)
which become effective October 28, 2002.

• Before operation
• Just starting out 6-month provisional MQSA
  certificate
• After accreditation 3-year full certificate
• Mammo facilities must be
• Accredited
• Certified
• Inspected
• Complementary

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2. It is the responsibility of the _____ to
ensure that the facility applies for and
completes accreditation renewal before MQSA
certificate expiration.

• A. Accrediting body
• B. Certifying body
• State inspectors
• D. Facility

10
When Do the MQSA Certificate and Accreditation
Expire?

• ACR expiration dates on certificate and unit
  label
• Against the law to perform mammo without a
  current MQSA certificate
• Medicare will not reimburse under expired
  certificate

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Meet All Application Deadlines

• Renewal notices sent out 8 months prior to
  accreditation expiration
• ACR must receive the complete entry application
  within 6 months prior to expiration
• You have 45 calendar days to return completed
  testing to ACR
• This guarantees completion of the review process
  before accreditation expiration

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3. In order to pass ACR accreditation, a facility
must perform and document that they pass all of
the QC tests outlined in the 1999 ACR Mammography
QC Manual.
TRUE or FALSE
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1999 ACR Quality Control Manual

• Aid for meeting FDA rules
• Consistent with MQSA requirements
• Additional recommendations for further quality
  improvement
• Meeting ACR recommendations not required for
  accreditation

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4. The ACR staff employees 25 full-time clinical
image reviewers and 15 phantom image reviewers
at their Reston, VA office to ensure quick turn
around of your accreditation images.
TRUE or FALSE
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ACR Image Reviewers

• 85 radiologists and 35 medical physicists
  qualified under MQSA
• In clinical (or physics) practice across the US
• Board certified
• 5 years of experience in accreditation modality
• Participate in formal training program
• May not review images from the same state

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5. Your phantom image fails if the medical
physicist reviewer cant see the following

• A. 5 largest fibers (after artifact subtraction)
• B. 4 largest speck groups (after artifact
  subtraction)
• C. 3 largest masses (after artifact subtraction)
• Fewer than 5 dust artifacts
• E. C and D

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Tips for Submitting Phantom Images Dosimeter

• Make test shot without dosimeter
• Dont cover fibers, specks, masses (or pink
  block) with dosimeter or disk

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Phantom Image Quality Evaluation

• In order to pass must see
• 4 largest fibers
• 3 largest speck groups
• 3 largest masses
• Background density measurement

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Phantom Image Quality Evaluation

• Phantom Image Reviewers use same criteria in ACR
  QC Manual
• Subtract artifacts if they appear
• Fiber-like
• Speck-like
• Mass-like

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6. ACR radiologist reviewers assume that clinical
images submitted for accreditation are

• A. Examples of your facilitys best work
• B. Examples of your facilitys typical work
• C. Benign cases
• Reviewed by your facilitys mammography QC
  technologist
• E. A and C

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Follow Instructions Submitting Clinical Images

• Examples of facilitys best work
• Supervising radiologist should review approve
  images
• Submit negative images
• BI-RADS assessment category 1 (nothing to
  comment onbreasts are symmetricalno masses,
  architectural disturbances or suspicious
  calcifications)
• ACR will accept BI-RADS assessment category 2
  (benign) with prior approval report
• Do NOT use models or volunteers

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7. The radiologist reviewers will not review
clinical images submitted for accreditation that
are not adequately fatty or dense.
TRUE or FALSE
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Different Breast Densities (BI-RADS) Present
Different Imaging Challenges
Comp Cat 2 25-50 glandular
Comp Cat 1 lt25 glandular
Fatty
Comp Cat 3 51-75 glandular
Comp Cat 4 gt75 glandular
Dense
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8. The major reason for failure of ACR
accreditation is

• A. Excessive patient dose
• B. Poor phantom image quality
• Poor clinical image quality
• Processor QC (more than 3 data points outside of
  control limits without corrective action)

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Clinical Image Quality Evaluated in Eight
Categories

• Positioning
• Compression
• Exposure level
• Contrast
• Sharpness
• Noise
• Artifacts
• Exam ID

• Review evaluation criteria in Clinical Image
  Evaluation section of 1999 QC Manual before
  submitting images
• (Primary reason for accreditation failure)

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1999 ACR Mammo QC Manual Clinical Image
Evaluation

• ACR Criteria for evaluating quality
• Guide for technical assessment of clinical images
  by radiologist
• Under MQSA radiologist must provide feedback to
  technologist
• Examples of poor and good clinical image

Underexposed
Properly Exposed
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9. Your facility does not pass accreditation
after the initial application. (The clinical
images were not acceptable.) You must immediately
cease performing mammography.
TRUE or FALSE
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Accreditation Attempts
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ACR Mammography Accreditation Program Pass Rates
1st Attempt
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Reasons for Failures 1st Attempt
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10. Your accredited facility just installed a new
unit. You must ___ before you examine patients
with that unit

• Have you medical physicist conduct an Equipment
  Evaluation on the unit
• Correct all problems identified during the
  Equipment Evaluation
• C. Send ACR the accreditation application and
  Equipment Evaluation results for the new unit
• D. All of the above

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Equipment Evaluations for New Units

• Must be done by qualified medical physicist
• This acceptance test evaluates different
  features in addition to those tested as part of
  the medical physicists annual QC survey
• Must be done ( all problems fixed) before
  equipment used on patients
• Must be submitted to ACR during initial
  application of new (or used) mammo unit

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Equipment Evaluations and Accreditation (New)

• Physicist can no longer tell facility that
  everything is OK and they may now use the new
  unit on patients
• Facility must also send ACR the medical
  physicists Equipment Evaluation results showing
  that everything passes before the facility may
  use the new unit on patients
• Required by FDA
• Effective February 15, 2003

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New Facilities

• Before beginning mammography (including
  applications training)
• Send in Entry App, fees and Equipment Evaluation
  Pass/Fail results to ACR (new!)
• All FDA-required tests must be done and pass
• Must receive 6-month provisional MQSA certificate
  (or interim notice)

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New Facilities

• ACR reviews and approves complete application and
  Equipment Evaluation and notifies FDA (or state
  certifier)
• FDA (or state certifier) sends 6-mo provisional
  MQSA certificate to facility
• Not more than 4 days from the time facility
  submits required documentation to ACR
• Recommend scheduling Equipment Evaluation 1 week
  before examining patients

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Accredited Facilities Installing New Units

• Application depends on time left on MQSA
  certificate
• gt13 mo complete New Unit Addendum (mid-cycle)
  application for new unit at reduced fee
• After approval, new unit has same expiration as
  other units
• lt13 mo all units must go through Renewal at
  usual fee
• Saves facility time and dollars
• New expiration date is old expiration date 3
  years

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Accredited Facilities Installing New Units

• May not use new unit for mammography until
• All FDA-required Equipment Evaluation tests are
  done and pass
• Facility sends in application, fees and Equipment
  Evaluation Pass/Fail results to ACR (new!)
• Facility does not have to wait for a response
  from ACR to use for mammography
• With a current MQSA certificate

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Equipment Evaluations for New Units (New)

• A rapid ACR review is essential for facilities
• Only summaries are required, BUT medical
  physicists must use ACR summary forms (sent with
  application materials also download from
  www.acr.org)
• MQSA Requirements for Mammography Equipment
  (checklist)
• Medical Physicists QC Test Summary form
• Different formats (even if they contain all the
  necessary information) will delay review

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Download Forms from ACR Website
900.12(b)
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Different Form for Screen-Film and Digital
900.12(e)
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One More Thing

• Equipment Evaluation
• Not required to complete Evaluation of Sites
  Technologist QC Program part of QC Test Summary
  at this time, BUT
• 45 days later when facility submits Full
  Application or Testing Materials
• ACR will request full Annual Survey report
• Evaluation of Sites Technologist QC Program
  must be completed for new unit
• Medical physicist may perform this evaluation by
  mail, fax, etc., but must do it

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Full-Field Digital Mammography (FFDM)
Accreditation
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FDA Approval of FFDM

• GE Senographe 2000D approved January 28, 2000
• Soft copy interpretation for GE approved November
  16, 2000

• Fischer Senoscan approved September 25, 2001
• Lorad Selenia Amorphous Selenium Direct-Capture
  System approved October 2, 2002

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FFDM Under MQSA

• At the time of approval, ACR did not have an
  accreditation program for full-field digital
• Not sufficient clinical experience to develop
  relevant QC or performance standards
• All other ACR accreditation programs developed
  after modality has been around for a while
• MQSA Catch 22
• In order to perform mammography, facilities must
  certified
• Facilities must be accredited before they can be
  certified

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FFDM Accreditation Module

• Subcommittee on Full-field Digital Mammography
  Accreditation, Chaired by Martin Yaffe, Ph.D.
• Developed (and tested) revised accreditation
  testing protocols and forms
• Conducted module pilot test in early 2001
• At the time, GE was only FDA-approved FFDM unit

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FDA Approved ACR to Accredit GE Senographe 2000D

• On December 18, 2002
• Effective February 15, 2003

47
Accreditation Process for GE FFDM

• General process is identical to screen-film
• Facilities will be able to have stand-alone
  digital systems (no screen-film required)

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Facilities with FDA-Approved Units

• Currently over 280 GE FFDM units approved by FDA
  at over 260 facilities
• ACR will phase in accreditation of these systems
• ACR will contact these FFDM facilities and let
  them know what to do
• ACR does not need to review these units
  Equipment Evaluations (already reviewed by FDA)

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ACRs Phase-In Plan
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Facilities Installing New GE FFDM Units

• Contact the ACR ASAP for appropriate
  accreditation materials
• Do not contact FDA

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QC Tests-Other Modalities 900.12(e)(6)

• For systems with image receptor modalities
  other than screen-film, the quality assurance
  program shall be substantially the same as the
  quality assurance program recommended by the
  image receptor manufacturer, except that the
  maximum allowable dose shall not exceed the
  maximum allowable dose for screen-film systems in
  paragraph (e)(5)(vi) of this section.

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FFDM QC

• Follow manufacturers QC manual procedures
• Meet manufacturers performance standards
• Suggest using manufacturers data forms, BUT must
  include ACRs summary forms for accreditation
• Failures must be fixed before use on patients (no
  more 30 days)
• GE applied for (and was granted) alternative
  standard to allow 30 days for some tests (e.g.,
  repeat analysis, collimation assessment, artifact
  evaluation flat field uniformity, etc)

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Technologist QC Tests (GE)
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Medical Physicist QC Tests (GE)
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Clinical Image Quality Evaluation Will Not Differ

• Hard copy images only
• Evaluate the same 8 attributes as screen-film
• Positioning Compression
• Exposure Contrast
• Sharpness Noise
• Artifacts Labeling
• ACR radiologists reviewing FFDM images are
  digital-qualified under MQSA

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Phantom Image Quality Evaluation Will Not Differ

• Hard copy images only
• Scoring is the same as screen-film
• Fibers
• Specks
• Masses
• Subtraction for artifacts
• ACR medical physicists reviewing FFDM images are
  digital-qualified under MQSA

57
Exposure Control Mechanism Differs for Each FFDM
Mfr

• Unit-specific instructions
• e.g., GE exposure control is impacted by the
  thickest/densest part of the breast
• Accreditation phantom rim and TLD holder result
  in higher exposure than 4.2 cm breast

X
58
Phantom Exposure and Dosimetry for GE FFDM

• Expose 4.2 cm tissue eq acrylic block under AOP
  to get technique
• 4.0 cm acrylic that covers active area of
  detector (14 x 16 cm)
• May use blocks provided by GE for AOP and SNR
  check
• Then expose accreditation phantom and dosimeter
  with closest manual technique

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Personnel Requirements are Different for FFDM

• Interpreting physician
• Medical physicist
• Radiologic technologist

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Interpreting Physician (FFDM)

• Initial training
• 8 hours (doesnt need to be Cat I)
• Special training courses
• Mfr applications training
• Residency training
• Hands on training (e.g., soft copy
  interpretation)
• Exemptions
• If began interpreting before 4/28/99
• Either document or attest
• Continuing education
• 6 Cat I CMEs every 36 months

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Medical Physicist (FFDM)

• Initial training
• 8 hours
• Special training courses
• Mfr applications training
• Graduate training
• Hands-on training (e.g., soft copy QC testing)
• Exemptions
• If began surveying units before 4/28/99
• Either document or attest
• Continuing education
• No specified
• Include CEUs in FFDM every 36 months

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Radiologic Technologist (FFDM)

• Initial training
• 8 hours
• Special training courses
• Mfr applications training
• RT training
• Include hands on training (e.g., QC testing)
• Exemptions
• If began using FFDM before 4/28/99
• Either document or attest
• Continuing education
• 6 CEUs every 36 months

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Recordkeeping and Transferring Records

• Images must be retained in a retrievable form
• May be digital or
• Hard copy
• Facilities must transfer original mammograms at
  the request of the patient FDA guidance says
• Must be film
• Must be of primary interpretation quality
• May not charge for 1st hardcopy version

64
FFDM Accreditation for Other Units

• ACR is currently developing of modules for other
  FDA-approved units
• Must be approved by the FDA

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The Future

• ACR is working with equipment manufacturers to
  develop a harmonized, evidence-based set of QC
  tests, test frequencies and performance criteria
• Benefit from the ACRIN/DMIST experience

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In SummaryThe Most Important Things to Remember
in Order to Pass Accreditation
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Read and Follow the Instructions

• Weve revised the Application and Testing
  Materials instructions based on your comments and
  questions to make them easier to follow
• Call us if you have questions

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Know When Your Accreditation and MQSA
Certification Expire

• Make every effort to stay within our timeframe
• If you dont submit your accreditation materials
  to us in a timely manner, we may have to fail
  your facility for non-compliance
• Our expiration date is on your ACR certificate
  and unit decal
• FDA and ACR are synchronizing dates

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Radiologists

• Dont assume everything is OK
• Radiologist is responsible for everything that
  impacts the interpretation of the patients films
• Lead interpreting physician has responsibility to
  ensure that the QA program meets all requirements
• ACR recommends that you review your facilitys QC
  at least quarterly
• Review and approve all accreditation materials
  (including clinical images)
• ACR sends all accreditation materials to the lead
  interpreting physician (he/she signs all survey
  agreements)

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Medical Physicists

• The medical physicist has responsibility over QC
• Talk with the technologists and radiologists ask
  them about problems and concerns have them show
  you
• Verbally explain your report to the facility
  staff
• Be aware of the new ACR Equipment Evaluation
  requirements for accreditation

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Mammography Technologists

• Keep your radiologist(s) informed and involved
• The lead interpreting physician has the
  responsibility of ensuring that the quality
  assurance program meets all MQSA requirements
• Be sure he/she reviews all accreditation
  materials (including clinical images) before
  sending them to the ACR

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For Additional Help on MQSA Certification and
Accreditation
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For More Information from FDA

• Facility Hotline at [phone]
• E-mail at MQSAhotline_at_SSSI.net
• Facts on Demand [phone]
• MQSA internet home pagehttp//www.fda.gov/cdrh/m
  ammography
• Policy Guidance Help System

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FDA Policy Guidance Help System Revised January
2003
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Need Help?

• www.acr.org

Marion

• Hotline staffed by ARRT(M) techs
• [phone]

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Watch the Breast Imaging Information Page
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American College of Radiology Quality Is Our
Image