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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????