Download Navigating the New ACR Breast MR Accreditation Program

Navigating the New ACR
Breast MR Accreditation Program
Marion Boston, RT (R)(M)
Assistant Director
ACR Breast Imaging Accreditation Programs
1
ACR Breast Imaging Accreditation Programs
• Mammography – MAP (1987)
• Stereotactic Breast Biopsy - SBBAP (1996)
• Ultrasound-Guided Breast Biopsy (1998)
• Breast Ultrasound, with USGBB Module – BUAP
(2000)
• Breast MRI - BMRAP (Launched May 10, 2010)
2
ACR Breast Imaging Centers of
Excellence (BICOE)
ACR Breast Imaging Centers of Excellence (BICOE)
• Initiated in October 2006
• A center must be fully accredited in:
– Mammography by ACR (or FDA-approved state
accrediting body)
– Stereotactic Breast Biopsy by the ACR
– Breast Ultrasound by the ACR (including the
Ultrasound-Guided Breast Biopsy module)
– Breast MRI is not applicable at this time
• For more information, go to
www.acr.org/accreditation/bicoe.aspx
4
BICOE
514 centers of excellence (July 2010)
5
BICOE
Possible Future Directions
• Participation in the National Mammography Database
(NMD)
• Accreditation for Breast MRI
• Need several years experience with programs before
making them mandatory
6
ACR Breast MRI Accreditation
(launched May 10, 2010)
Breast MRI Accreditation Program
Committee On Breast MRI Accreditation
– Constance Lehman, MD, PhD, Chair
– Elizabeth Morris, MD, Co-Chair
– Ed Hendrick PhD
– Nola Hylton PhD
–
–
–
–
–
Paul Larson, MD
Carol Lee, MD
Deb Monticciolo, MD
Ronald Price, PhD
Charles Truwit, MD
– Mitchell Schnall, MD, PhD
– Jeff Weinreb, MD
– Rudy Lin, MD
– Bernadette Redd, MD
– Wendy DeMartini, M.D.
Staff:
– Priscilla Butler
– Marion Boston
– Theresa Branham
– Pamela Wilcox
8
Breast MRI Accreditation Program MIPPA
Under the Medicare Improvement for Patients and
Providers Act of 2008 (MIPPA), all facilities providing the
technical component (TC) of advanced diagnostic
imaging services, such as breast MRI, must become
accredited by a CMS-designated accrediting organization
by January 1, 2012 in order to qualify for Medicare
reimbursement. This rule affects providers of MRI, CT,
PET and nuclear medicine imaging services for Medicare
beneficiaries on an outpatient basis
9
Breast MRI Accreditation Program MIPPA
• All providers who bill for the technical component for
MRI, CT, Nuclear Medicine under the Fee Schedule (not
hospitals) must be accredited by January 1, 2012
• This includes breast MRI
• No accreditation NO REIMBURSEMENT
• ACR BMRAP has been approved by CMS under MIPPA
accreditation requirements
10
Breast MRI Accreditation Program MIPPA
CMS New Requirements
• Primary source verification of personnel qualifications
• Inform patients/caregivers how to obtain records
• Consumer complaints
• Post a notice about how a consumer can file a complaint with
the accrediting organization
• Policies for staff and patient safety
11
Breast MRI Accreditation Program MIPPA
Validation Audits
• Comprehensive
• Focus on a particular issue
• Unannounced
• Representative sample of suppliers
12
Breast MRI Accreditation Program MIPPA
Consumer Complaints
• Like MQSA must have process in place
• Complaint must be written, signed
– Not anonymous
• Must post notice of complaint process for patients
• Report to other “appropriate licensing body”
– Any regulatory body
– State radiation control
– Nuclear Regulatory Commission
13
Breast MRI Accreditation Program MIPPA
Primary Source Verification
New for MIPPA
Verification is a direct contact with the sources of
credentials. For example, this may include residency
programs, licensing agencies, and specialty boards to
guarantee that statements about training, experience and
other qualifications are legitimate, unchallenged and
appropriate.
14
Breast MRI Accreditation Program MIPPA
• Requires accreditation for outpatient providers of
advanced imaging (MR,CT,NM,PET) by 1/1/12
• CMS approved accrediting bodies by 1/1/10
• ACR approved as an accrediting body for all modalities
– In breast imaging only applies to breast MR
15
Facility Completes
Entry Application
ACR Reviews Entry Application;
Sends Facility Full Application
Facility Completes Full
Application & Returns to ACR
ACR Reviews Full
Application
Accreditation
Process for
Breast MRI
Clinical Image
Review
ACR Writes Final
Report
Facility/Unit
Deficiency (1st)
Facility
Repeats,
Appeals or
Withdraws
or
Facility/Unit
Passes
ACR Notifies
MIPPA
Facility Renews
Accreditation in 3 Years
Breast MRI Accreditation Program Requirements
• Based on ACR Practice Guideline for the Performance of
Contrast-Enhanced Magnetic Resonance Imaging (MRI)
of the Breast
• Provides facilities with peer review and constructive
feedback on their staff’s qualifications, equipment,
quality control (QC), quality assurance, MR safety
policies and image quality
17
Breast MRI Accreditation Program Requirements
• Facilities performing breast MRI must have the capacity
to perform mammographic correlation, directed breast
ultrasound, and MRI-guided intervention, or create a
referral arrangement with a cooperating facility that could
provide these services
• The cooperating facility must be accredited by the ACR in
breast MRI (or, until May 10, 2011, has had an application
for breast MRI accreditation accepted by the ACR)
18
Breast MRI Accreditation Program Requirements
• Qualifications for physician
• Qualifications for radiologic technologists
• Qualifications for medical physicists/MR scientists
• Equipment specifications
• Biopsy, directed ultrasound & mammo correlation
capabilities
• Clinical images
• Compliance with BIRADS® final assessments
• QA & QC requirements
• Compliance with MRI safety guidance
19
Breast MRI Accreditation Program Requirements
• Submit clinical images and corresponding data for each
magnet performing breast MRI
• No phantom required at this time
• Does not evaluate MR-guided biopsy (yet)
20
Breast MRI Accreditation Program Personnel
Qualifications
• Interpreting Physician
Must have knowledge and expertise in breast disease and breast
imaging diagnosis. In addition, the physician has the
responsibility for all aspects of the study including:
– Reviewing all indications for the examination
– Specifying the pulse sequences to be performed
– Specifying the use and dosage of contrast agents
– Ensuring that a physician is present and immediately available
when contrast is administered to patients
– Interpreting images
– Generating official interpretations (final reports)
– Assuring the quality of both the images and interpretations
21
Breast MRI Accreditation Program Personnel
Qualifications
Initial Qualification - Radiologist
Board Certified
– Certification in Radiology or Diagnostic Radiology by the
• American Board of Radiology, or
• American Osteopathic Board of Radiology, or
• Royal College of Physicians and Surgeons of Canada, or
• Le College des Medecins du Quebec
AND
• Supervision, interpretation and reporting of 150 breast MRI
examinations in the last 36 months, or
• Interpretation and reporting of 100 breast MRI examinations in
the last 36 months in a supervised situation
OR
22
Breast MRI Accreditation Program Personnel
Qualifications
Initial Qualification – Radiologist (continued)
Not Board Certified
– Completion of an Accreditation Council for Graduate Medical
Education (ACGME) or American Osteopathic Association (AOA)
approved diagnostic radiology residency program, and
– Interpretation and reporting of 100 breast MRI examinations in the last
36 months in a supervised situation
AND
– 15 hours of Category 1 Continuing Medical Education (CME) in MRI
(including clinical applications of MRI in breast imaging, MRI artifacts,
safety, and instrumentation) in the last 36 months
23
Breast MRI Accreditation Program Personnel
Qualifications
• Continuing Experience – Radiologist
– 75 breast MRI examinations in the prior 24 months (upon renewal)
• Continuing Education – Radiologist
– 5 hours Category 1 CME in breast MRI in the prior 36 months (upon
renewal)
24
Breast MRI Accreditation Program Personnel
Qualifications
Initial Qualification – Technologist
• Registered in MRI by the
• American Registry of Radiologic Technologists (ARRT), or
• American Registry of MRI Technologists (ARMRIT), or
• Royal College of Physicians and Surgeons of Canada, or
• Canadian Association of Medical Radiation Technologists (CAMRT)
OR
• Registered in radiography by the ARRT and/or unlimited state license, and
• 6 months supervised clinical MRI scanning experience
OR
• Associate’s or bachelor’s degree in an allied health field, and
• Certification in another clinical imaging field (e.g., ARDMS or NMTCB),
and
• 6 months supervised clinical MRI scanning experience
AND
25
Breast MRI Accreditation Program Personnel
Qualifications
Initial Qualification – Technologist (continued)
• Licensure in the state in which he/she practices (if required for MRI
technologists)
AND
• Supervised experience in breast MRI, and
• Supervised experience in the intravenous administration of MR contrast (if
contrast administration is performed by the technologist)
26
Breast MRI Accreditation Program Personnel
Qualifications
•
Continuing Experience - Technologist
•
Continuing Education - Technologist
– Upon renewal, 50 breast MRI examinations in the prior 24 months
– Registered technologist
• In compliance with the CE requirements of their certifying organization for the
imaging modality in which they perform services
• CE includes credits pertinent to the technologist’s ACR accredited clinical practice
– State licensed technologists
• 24 hours of CE every 2 years
• CE is relevant to imaging and the radiologic sciences, patient care
• CE includes credits pertinent to the technologist’s ACR accredited clinical practice
– All others
• 24 hours of CE every 2 years
• CE is relevant to imaging and the radiologic sciences, patient care
• CE includes credits pertinent to the technologist’s ACR accredited clinical practice
27
Breast MRI Accreditation Program Personnel
Qualifications
The medical physicist/MR scientist must:
• Be familiar with the principles of MRI safety for patients, personnel, and
the public; the Food and Drug Administration’s guidance for MR diagnostic
devices; and other regulations pertaining to the performance of the
equipment being monitored.
• Be knowledgeable in the field of MR physics and familiar with MRI
technology, including function, clinical uses, and performance
specifications of MRI equipment, as well as calibration processes and
limitations of the performance testing hardware, procedures, and
algorithms.
• Have a working understanding of clinical imaging protocols and methods
of their optimization. This proficiency should be maintained by
participation in continuing education programs of sufficient frequency to
ensure familiarity with current concepts, equipment, and procedures.
28
Breast MRI Accreditation Program Personnel
Qualifications
Initial Qualifications – Medical Physicist or MR Scientist
Board Certified
– Certification in Diagnostic Radiological Physics or Radiological
Physics by the American Board of Radiology; in Diagnostic
Imaging Physics or Magnetic Resonance Imaging Physics by the
American Board of Medical Physics; or in Diagnostic Radiology
Physics or Magnetic Resonance Imaging Physics by the
Canadian College of Physicists in Medicine
OR
29
Breast MRI Accreditation Program Personnel
Qualifications
Not Board Certified in Required Subspecialty
• Graduate degree in medical physics, radiologic physics, physics, or other
relevant physical science or engineering discipline from an accredited
institution, and
• Formal coursework in the biological sciences with at least
– 1 course in biology or radiation biology, and
– 1 course in anatomy, physiology, or similar topics related to the
practice of medical physics
• 3 years of documented experience in a clinical MRI environment
OR
Grandfathered
• Conducted surveys of at least 3 MRI units between January 1, 2007 and
January 1, 2010
30
Breast MRI Accreditation Program Personnel
Qualifications
• Continuing Experience – Medical Physicist/MR Scientist
– 2 MRI unit surveys in prior 24 months (upon renewal)
• Continuing Education – Medical Physicist/MR Scientist
– 15 CEU/CME (1/2 Cat 1) in prior 36 months (must include credits
pertinent to the accredited modality (upon renewal)
31
Breast MRI Accreditation Program Requirements
Not Board Certified in Required Subspecialty
• Graduate degree in medical physics, radiologic physics, physics, or other
relevant physical science or engineering discipline from an accredited
institution, and
• Formal coursework in the biological sciences with at least
– 1 course in biology or radiation biology, and
– 1 course in anatomy, physiology, or similar topics related to the
practice of medical physics
• 3 years of documented experience in a clinical MRI environment
32
Breast MRI Accreditation Program Equipment
Requirements
• No requirement for minimum field strength
• MR Equipment must:
– Have a dedicated, bilateral breast coil
– Be capable of simultaneous, bilateral, imaging
– Meet all state and federal performance requirements, including those
for:
• Maximum static magnetic field strength
• Maximum rate of change of magnetic field strength (dB/dt)
• Maximum radiofrequency power deposition (specific absorption
rate)
• Maximum auditory noise levels
• In addition, facilities performing breast MRI must have the equipment to
perform MRI-guided intervention, or create a referral arrangement with a
cooperating facility that could provide these services
33
Breast MRI Accreditation Program Quality Control
• Documentation of QC is required
– Tests are in the 2004 ACR Magnetic Resonance Imaging (MRI) QC Manual
• All new facilities to the BMRAP will receive a manual as part of the
package
• Facilities must demonstrate compliance with the ACR requirements for QC
by providing:
– The most recent Annual MRI System Performance Evaluation report, including
indication that the performance of the site’s bilateral breast coil(s) has been
checked and was acceptable
– Documentation of corrective action (if the Annual MRI System Performance
Evaluation and/or QC data identify performance problems)
• Use of current MRI Phantom may not be possible for all QC in breast
imaging
– Choice of phantom QC and the resultant action criteria must be made by the qualified
medical physicist/MR scientist in cooperation with the system vendor
34
Breast MRI Accreditation Program
Annual Survey
• Acceptance testing for new equipment
•
Perform the following QC tests annually
– Magnetic Field Homogeneity
– Slice Position Accuracy
– Slice Thickness Accuracy
– Radiofrequency Coil Checks
– Soft-Copy Displays (monitors)
– Evaluation of QC Program
35
Breast MRI Accreditation Program
Technologist QC
• Implemented for all MRI units and established with the assistance of
your medical physicist/MR scientist
• The following QC tests are performed weekly
– Table Positioning
– Setup and Scanning
– Center (central) Frequency
– Transmitter Gain or Attenuation
– Geometric Accuracy
– High-Contrast (Spatial) Resolution
– Low-Contrast Resolution (Detectability)
– Artifact Analysis
– Film (Hardcopy Image) QC
– Visual Checklist
36
Breast MRI Accreditation
Program Requirements
• Quality Assurance
– Must establish and maintain a medical outcomes audit program to follow up
positive assessments and correlate pathology results with interpreting
physician findings
• BI-RAD®
– Category 1 – Negative
– Category 2 – Benign Finding(s)
– Category 3 – Probably Benign Findings; short-interval follow-up suggested
– Category 4 – Suspicious Abnormality; biopsy should be considered
– Category 5 – Highly Suggested of Malignancy; appropriate action should be
taken
– Category 6 – Known Biopsy-Proven Malignancy; appropriate action should be
taken
37
Breast MRI Accreditation Program
Clinical Images
• 2 bilateral breast MRI cases
– 1 known, enhancing, biopsy-proven carcinoma
– 1 benign finding
• Must include 4 sequences:
– T2-Weighted/Bright fluid series
– Multi-Phase T1-Weighted series
• Pre-Contrast T1
• Early Phase Post-Contrast T1
• Delayed Phase Post-Contrast T1
38
Breast MRI Accreditation Program
Clinical Images
• Will be reviewed by 2 ACR radiologist reviewers
• 5 categories to be reviewed
– Pulse sequences and image contrast
– Positioning and anatomic coverage
– Artifacts
– Spatial and temporal resolution
– Exam ID
39
ACR Breast Imaging Guideline
and Policy Updates
Breast Imaging Guidelines
www.acr.org
• Screening and diagnostic mammography (2008)
• Breast MRI (2008)
• Ultrasound guided breast biopsy (2009)
• Stereotactic breast biopsy (2009)
• MRI-guided breast biopsy (expected in 2010)
• New ACR-SBI breast screening statement (JACR 2010)
41
BI-RADS® Atlas
• Revision in progress (last version-2004)
• Carl D’Orsi, MD – Chair
– Mammography subcommittee: Ed Sickles, MD – chair
– Ultrasound subcommittee: Ellen Mendelson, MD – chair
– MRI subcommittee: Elizabeth Morris, MD and Debra Ikeda, MD –
co-chairs
• Expected in 2010
• New FAQs on multimodality
and audit benchmarks
available on ACR website
42
New National Mammography Database
• Launched July 2009
• Compare physician medical audit performance against
peers
• Participating vendors (as of 10/09)
– Insight
– Jambeyang Research
– MagView
– MRS
– PenRad
– Swearingen
43
Appropriateness Criteria - Breast
• Breast microcalcifications
• Nonpalpable breast masses
• Palpable breast masses
• Stage I carcinoma
44
The ACR Website Has Lots of Info…If you Know
Where to Find It
45
www.acr.org/Breast-Imaging
New!
Patients and Referring Physicians Can
Find Accredited Facilities
47
Thank You
Questions????