Maintaining a quality mammography facility: Overview of ACR and MQSA Requirements and Update on BI-RADS 5 TH Edition

Maintaining a quality mammography facility: Overview of ACR and MQSA Requirements and Update on BI-RADS 5 TH Edition Sandra S. Rao, M.D. Northwestern Medicine I have nothing to disclose.

Objectives: Review accreditation requirements Understand how to successfully obtain and renew FDA certification Describe changes in the 5 th Edition BI- RADS for Assessment Categories and recommendations Discuss the update in the BI-RADS classification of breast densitiy

MQSA FDA Certification and ACR Accreditation With a special thank you for providing information to: Judith A. Wolfman, M.D., F.A.C.R.

Breast Imaging: Accreditation & Certification Mammography Film-Screen Digital Ultrasound Stereotactic Unit Must be Accredited by ACR and Certified by FDA Voluntary ACR Accreditation MRI Voluntary ACR Accreditation, May, 2010; Required for CMS reimbursement Jan, 2012

Mammography Accreditation & Certification How did we get here? Professional Concerns about quality of mammography Voluntary Accreditation Programs Illinois Radiological Society, 1986 ACR Accreditation Program, 1987

and Public Concern & Advocacy

History of Mammography Accreditation & Certification 1992 President Bush signed the Mammography Quality Standards Act 1994 FDA s Interim Rules required all mammography facilities in the US to be accredited, certified and inspected QC regs mirrored the ACR requirements 1999 FDA s Final Rules went into effect with new detailed requirements, including direct patient notification

?? MQSA, FDA, ACR??? MQSA = Mammography Quality Standards Act - Legislation passed by US Congress on 10/23/92 - Stipulated that as of October 1, 1994, all mammography facilities were to be accredited by an approved accreditation body & certified by the FDA FDA = Food & Drug Administration Approves the Accreditation Body Certifies the Mammography facility Issues an MQSA Certificate when the accreditation body notifies the FDA that the facility has been accredited. Certification valid for 3 years Performs annual Inspections Penalty for performing mammography without certification are severe (up to $10K per exam performed) ACR = American College of Radiology Mammography Accreditation Program Certified by FDA as accreditation body Must meet MQSA requirements as published by FDA

MQSA Final Regulations Proposed Regulations Published 4/3/96 Final Regulations Published 10/28/97 Implementation 4/28/99 Reauthorization signed into law 10/9/98 Requires lay summary of results to all patients Release of original mammograms temporary and permanent

Facility Requirements Under MQSA DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 900 Quality Mammography Standards AGENCY: Food and Drug Administration, HHS. ACTION: Final rule As 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. A certificate is required before operation - 6-month provisional if just starting out; - 3-year full certificate after accreditation Mammo facilities must be: Accredited, every 3 yrs Certified, every 3 yrs Inspected, every year Complementary, not duplicative

ACR Accreditation is required by the FDA for which of the following Breast Imaging modalities???: 1. Mammography 2. Breast Ultrasound 3. Breast MRI 4. Stereotactic Breast Biopsy 5. All of the above

ACR Accreditation is required by the FDA for which of the following Breast Imaging modalities: 1. Mammography 2. Breast Ultrasound 3. Breast MRI 4. Stereotactic Breast Biopsy 5. All of the above

FDA Certification Requirements The Mammography Facility must meet the following Quality Standards as described in Section 900.12 of the final as published in the Federal Register: 900.12(a) - Personnel 900.12(b) - Mammography equipment 900.12(c) - Medical records & reports 900.12(d) - Quality Assurance general 900.12(e) - Quality Assurance equipment 900.12(f) - Quality Assurance Medical outcomes audit 900.12(g) - Mammographic Procedure for examinees with implants 900.12(h) - Consumer complaint mechanism 900.12(f) Additional Clinical Image Review and Notification 900.12(f) Additional mammography review and patient notification

ACR Mammography Accreditation for FDA Certification Application requires documentation of: -Personnel Qualifications -Equipment and documentation of QC program -Physicist inspection report Phantom and Clinical Image Submission: -ACR Phantom obtained with TLD for documentation of image quality and dose - Clinical Images: Fatty and Dense => 2-view mammogram of each type

Personnel: State license Interpreting Physicians Initial Qualifications Diagnostic radiology certification OR 3 months of formal training 60 hours of category I CME in mammography 240+ mammograms interpreted under the direct supervision In the 6 months immediately prior to independent interpretation OR If board certified at first allowable time, within the last 2 years of residency

Interpreting Physicians Continuing Requirements Continuing experience Interpret at least 960 examinations/ 24 months Continuing education At least 15 category I CME credits/ 36 months At least 6 of the 15 CME units must be in each mammographic modality used 8 hours of training in each mammographic modality before independent use, i.e. film vs. digital vs. tomosynthesis

Interpreting Physicians Reestablishing Qualifications Continuing experience Interpret or multi-read under direct supervision EITHER 240 examinations OR enough examinations to bring total to 960/24 months Interpretations performed in immediate 6 months prior to resuming independent reading Continuing education Bring total CME credits up to 15 unit/36 months

Radiologic Technologists State license OR Initial Qualifications Certified by FDA-approved body 40 hours of documented mammography training Performing at least 25 examinations under direct supervision 8 hours of training in each mammographic modality to be used

Radiologic Technologists Continuing Requirements Continuing experience Perform at least 200 examinations/ 24 months Continuing education At least 15 CEUs/ 36 months At least 6 of the 15 CEUs must be in each mammographic modality used 8 hours of training in each mammographic modality before independent use, i.e. film vs. digital

Radiologic Technologists Reestablishing Qualifications Continuing experience Complete 25 examinations under direct supervision Continuing education Bring total CEUs up to 15 credits/36 months

Medical Physicists Initial Qualifications Licensed or approved by a State OR Certified by FDA-approved body Master s or higher degree in a physical science 20 semester hours of physics 20 hours of documented mammography survey training One facility and 10 units surveyed 8 hours of training in each modality surveyed before surveying independently

Medical Physicists Continuing Requirements Continuing experience Survey at least 2 facilities & 6 units/ 24 months Continuing education At least 15 CEUs/ 36 months At least 6 of the 15 CEUs must be in each mammographic modality used 8 hours of training in each mammographic modality before independent use

Medical Physicists Reestablishing Qualifications Direct Supervision Continuing experience Bring total number of supervised surveys up to 2 facilities and 6 units / 24 months Continuing education Bring total CEUs up to 15 credits/36 months

To meet the initial qualifications for the interpretation of mammography, the physician must interpret how many mammography exams under the supervision of a qualified radiologist? 1. 160 2. 240 3. 460 4. 960

Equipment Standards Specific Requirements Equipment must be designed for mammography Motion of tube-image receptor assembly Capable of being fixed in any position No unintended motion during power interruption Image receptor sizes for each screen-film unit 18 x 24 cm and 24 x 30 cm cassettes 18 x 24 cm and 24 x 30 cm moving grid

Equipment Standards Specific Requirements (cont.) Light fields Provide average illumination of 160 lux at 100 cm Magnification capacity Systems designed for magnification provide at least one magnification in the range of 1.4 to 2.0

Equipment Standards Specific Requirements (cont.) Breast Compression Devices Compression paddles For each image receptor size Flat and parallel to the breast support table, OR If paddle not designed to be flat and parallel, meet manufacturer s design and maintenance requirements Hands-free initial power driven compression Operable from both sides of patient Fine adjustment controls

Equipment Standards Specific Requirements (cont.) Technique factor selection and display Manual selection of mas available Technique factors indicated before exposure Automatic exposure control AEC operable in all clinically used modes Flexible positioning of detector Selected optical density may be varied from normal (zero) setting

Equipment Standards Specific Requirements (cont.) Display of selected focal spot and/or target material X-ray film designed for mammography Intensifying screens matched to film Film processing solutions meet film requirements High-intensity lighting (hot-lights) available Film masking devices available

Reporting and Recordkeeping Standards Overall Assessment of Findings Report identifies interpreting physician Assessment Categories: Negative Benign Probably Benign Suspicious Highly Suggestive of Malignancy Incomplete: Need additional imaging evaluation

Reporting and Recordkeeping Standards Communication of Results Report sent to referring health care provider (or patient with no health care provider) within 30 days Suspicious or Highly suggestive of malignancy results communicated to health care provider and patient as soon as possible (ideally, within 3-5 days) Summary report written in lay language sent to all patients within 30 days Self-referred patients receive both the lay language letter and the mammography report

Reporting and Recordkeeping Standards: Mammographic Image information Patient name, Patient identifier Facility name & location Date of Exam Technologist ID Mammo Unit ID View & Laterality Technical Factors

Medical Records and Reports Medical reports and films kept by facilities for: 5 years, OR 10 years if no additional mammography performed on patient at that facility, OR Longer if required by state or local law Original films transferred ( temporary or permanent) upon request of patient or patient s representative Fee charged may not exceed documented cost incurred by the facility

Medical Records and Reports (cont.) Inspectors will ask to see: Randomly selected records Sample reports sent to referring health care provider Template of lay summary of mammography report sent to patient System for communicating findings Randomly selected reports Interpreting physicians identified Assessment Categories

General Administrative Requirements Responsible staff: Lead interpreting physician Interpreting physicians Medical physicist Quality control technologist Responsible for meeting quality assurance recordkeeping requirements

Equipment Quality Assurance Specifications for: Tests to be performed Frequency Action limits Facility generally free to choose test procedures that meet its needs For non-screen-film equipment, follow manufacturer s quality assurance instructions

Equipment Quality Assurance Tests Other Than Annual (SFM) Daily tests: Film processor Weekly tests: Phantom image Quarterly tests: Fixer retention Repeat analysis Semiannual tests: Darkroom fog Screen-film contact Compression device performance

ACR Phantom on Screen-Film Same Target-Filter and kvp: Mo-Mo 26 kvp Underexposed Proper Exposure Overexposed 56 mas Lower Contrast 104 mas 200 mas Lower Contrast

In order to pass must see 4 largest fibers 3 largest speck groups 3 largest masses Subtract artifacts if they appear Fiber-like Speck-like Mass-like Phantom Image Quality Evaluation

Equipment Quality Assurance Annual Tests (SFM) Automatic exposure control Kilovoltage peak accuracy Focal spot condition Beam quality and half-value layer Breast entrance air kerma and AEC reproducibility Dosimetry X-ray field/ light field/ image receptor/ compression paddle alignment Uniformity of screen speed System artifacts Radiation output Decompression

Equipment Quality Assurance Mobile Units (SFM) Performance testing of mobile units for image quality accuracy At each location and before imaging patients Examples of acceptable tests Phantom testing Acceptable limits for variation in mas Other tests

Equipment Quality Assurance Test Results (SFM) Use of test results Compare results to action limits For results out of limits Identify source of problem Take corrective action and document

Equipment Quality Assurance Corrective Action Time Frames Before use of failed component for: Processor Phantom Fog Screen-film contact Compression Dose Other modality receptors Mobile unit Within 30 days for all other tests

Quality Assurance: Digital Mammography Medical Physicist & Tech QC Must use manufacturer s QC procedures Most failures result in stopping clinical imaging until failure can be corrected Know when to use raw vs. processed

Screen-Film vs. Digital Mammography Image Receptor Resolution or pixelation Contrast differences between SFM and FFDM SNR replaces Optical Density as metric for judging image quality Image postprocessing

Image Acquisition: Film-Screen Imaging Chain Film Film Film Film Processor Alternator File Room Film Acquisition Processing Display Storage *E.Berns, modified

Digital Image Formation X-ray Tube Computer Digital Detector Signal Readout A/D X-ray Unit Softcopy Display E. Berns

Digital Imaging Chain Signal readout For- Processing image RAW PACS archive Digital detector For- Presentation Image Processed RWS FFDM computer => Dissociated RWS: -Adjust contrast / brightness - Zoom or electronic magnification -additional processing *E.Berns, modified

Basic Digital Mammography Image Receptor Paddle Breast Grid Scintillator converts x-rays to visible light Electronic Detector Counts Photons Photon count per pixel = signal value on monitor Pixel Width Electric current Computer (E. Berns)

Approaches to Digital Mammography Silicon Diode Array (GE) Slot Scanning Phosphor-CCD (Fischer) Selenium with Silicon Diode Array (Lorad, Siemens, Others) Computed Radiography (Fuji) Tiled CCD Arrays (LORAD) - discontinued E. Berns

Processing Steps for Digital Images True Raw Image Raw Image (Bad Pixel and Gain- Corrected) Processed Image (Thicknessequalized)

Digital Image Formation Goal: Algorithm: Thickness Compensation To visualize the entire breast with a single window setting. 1. Add a nearly-equivalent thickness [of water] to raise gray levels. * Note: This is only applied near the skin-line Raw TC-Processed Line-Profile through Breast Compensated Thickness { Breast Thickness {

Thickness Equalization Algorithm Skin Line Uniformly Thick Part of Breast Modified Portion of Image Processed Raw Digital Image

Approaches to Digital Image Display Detector Size (cm) vs. Image size (pixels) 5370 Fischer 29 Lorad & Siemens Fischer 4143 2560 Lorad & Siemens Monitor 23 GE 2304 GE 19 21 24 1920 2048 3429 3889

Resolution SFM FFDM Effectively 12-15 lp/mm in contact mode GE Fischer & Siemens Lorad Fuji (CR) 100 mm (5 lp/mm) 54 mm (9.3 lp/mm) 70 mm (7.1 lp/mm) 62 mm (8.1 lp/mm)

Quality Assurance: Digital Technologist Tests FFDM Only Monitor Cleaning Laser printer sensitometry Contrast-to-Noise Ratio (CNR) System Resolution & Scan Speed Flat Field and/or Detector Calibrations Uniformity SNR Checks Clean CR Reader and Work Area Viewing Conditions & Monitor QC MTF Check AOP or AEC Check Phantom Daily erasure of plates Inspection and cleaning of plates Cleaning air vents

ACR Phantom on Digital Technique factors matched to FSM: Mo-Mo 26 kvp Underexposed Proper Exposure Overexposed 50 mas Lower SNR 100 mas 200 mas Higher SNR

Image Quality in Screen-film and Digital Mammography In screen-film mammography, image quality is determined by film optical density (OD) In digital mammography, image quality is determined by signal-to-noise ratios

Quality Control: Digital Medical Physicist Tests FFDM (specified by Manufacturer) Viewing conditions check and setting Monitor calibration - Artifact evaluation Image quality SMPTE pattern AOP Mode and SNR Check Analysis of RWS screen uniformity ACR Phantom & Contrast-to-Noise Ratio (CNR) System resolution/scan speed uniformity Check Flat field test MTF measurement Geometric distortion and resolution uniformity Collimation Assessment System artifacts X-ray field size and Chest wall missed tissue Image display monitor(s) check Tech Review Compression paddle alignment Ghost Image Linearity, reproducibility, and accuracy SNR and CNR Softcopy Workstation QC AEC Thickness Tracking CR reader sensitivity ( S number) Pixel Correction CR reader shading correction Detector Calibration Imaging plate fogging test Verification of AEC with CR cassettes on each unit

RWS Monitor Quality Control SMPTE Pattern Luminance Levels RWS Screen Uniformity Clinical Image Check Viewing Conditions Check

RWS SMPTE Patterns: 5% & 95% contrast boxes 10% contrast boxes High contrast line-pair resolution

High Contrast Line Pair Patterns 1 pixel/line Vert Horiz 2 pixel/line Vert Horiz 4 pixels/line Vert Horiz

Calibrate monitors each day Record min and max luminance Luminance Levels Measure luminance at: 0 60 120 180 255 Compare to baseline must be within action limits Or

RWS Clinical Image Check Does the background match? Is the background dark enough? Does the dense tissue area match? Is the dense tissue light enough? Is the contrast adequate?

RWS Clinical Image Check

Equipment Quality Assurance Medical Physicist Survey All annual QC tests for all mammography modalities Review of facility s equipment test records and corrective actions Survey report Includes summary and recommendations for corrective action Dated and signed by qualified medical physicist who performed or supervised the survey Sent to facility within 30 days (earlier for major problems)

Equipment Quality Assurance Mammography Equipment Evaluations Conducted or supervised by medical physicist On newly installed equipment prior to use on patients After disassembly and reassembly of equipment After major component change or repair Problems detected must be corrected before equipment is put into service Facility must maintain documentation for system

Infection Control Facility must establish procedures for cleaning and disinfecting mammography equipment Procedures must comply with existing federal, state, and local laws Procedures must comply with manufacturer s recommendaiton for cleaning and disinfection

Inspection of QA and QC Programs Inspector will confirm that facility has: Established a QA program Designated qualified personnel The inspector will check records for: Daily processor quality control tests Weekly phantom image tests Quarterly repeat analysis test Semiannual darkroom fog tests Digital QC performed as per manufacturer

Inspection of QA and QC Programs (cont.) The inspector will check records for (cont): Semiannual screen-film contact tests Semiannual compression tests Personnel responsibilities and procedures for QA/QC testing Other QA-related written policies, procedures and records Mammography technique charts

Inspection of QA and QC Programs (cont.) The QC records should show that tests were: Conducted at regulated frequencies Conducted according to the appropriate manual or manuals Followed up by any corrective actions shown to be necessary Corrective actions must be documented

Mammography Medical Outcomes Audit System required to track all positive mammograms Positive = Final Assessment of Suspicious or Highly Suggestive of Malignancy Obtain pathology results for all biopsies performed Facility assigns at least one physician to ensure that: Data is collected for the facility and individual interpreting physician analyzed once every 12 months Follow-up actions are documented, if any are taken Effective tool for maintaining or improving the quality of interpretations

Medical Audit and Outcome Analysis Records Track all positive mammograms (separation of screening vs diagnostic not required) Correlate findings with pathology results for all biopsies performed Include cancers of which the facility becomes aware and correlate with the imaging Inspector will: Examine tracking system Ask how biopsy results obtained Ask to see examples of reports obtained by the facility Confirm that analysis is performed annually

FDA Certification Requirements The Mammography Facility must meet the following Quality Standards as described in Section 900.12 of the final as published in the Federal Register: 900.12(a) - Personnel 900.12(b) - Mammography equipment 900.12(c) - Medical records & reports 900.12(d) - Quality Assurance general 900.12(e) - Quality Assurance equipment 900.12(f) - Quality Assurance Medical outcomes audit 900.12(g)-Mammographic Procedure for examinees with implants 900.12(h) - Consumer complaint mechanism 900.12(f) Additional Clinical Image Review and Notification 900.12(f) Additional mammography review and patient notification

Breast Implant Imaging To ensure adequate examinations of the estimated 2 million women with breast implants Primary requirements Inquire about implants before the exam is performed Maximize visualization of breast tissue Radiologic technologists qualifying after April 28, 1999, must have breast imaging training

Consumer Complaints Facility must develop written system for collecting and resolving complaints Complaints that cannot be resolved at facility are referred to the accreditation body Complaints not resolved by accreditation body are referred to the FDA Serious complaints are reports of events that could adversely affect clinical outcomes Facility must maintain records of serious complaints for at least 3 years

MQSA requires that the Mammography Medical Outcome audit include tracking of the following Assessment Categories: 1. BI-RADS 0 2. BI-RADS 3 3. BI-RADS 4 4. BI-RADS 5

Additional Mammography Review and Patient Notification If FDA believes mammography quality compromised Facility provides clinical images for additional review to accreditation body or an entity designated by the FDA Based on review, FDA determines whether to notify affected patients and referring health care providers.

For Complete MQSA-FDA Information: http://www.fda.gov/cdrh/mammography

Breast Imaging Center of Excellence ACR recognition of breast imaging centers that achieve excellence by accreditation in all of ACR s voluntary breast imaging accreditation programs and modules, including: Mammography (ACR or an FDA-approved state accrediting body) Stereotactic Breast Biopsy by ACR Breast Ultrasound by ACR including biopsy module (MRI currently not included)

ACR Breast Ultrasound Accreditation Breast Ultrasound Ultrasound-Guided Breast Biopsy Module

ACR Breast Ultrasound Accreditation: Physician Qualifications All physicians who supervise, perform &/or interpret breast ultrasound exams must: Be licensed medical practioners Have a thorough understanding of indications for breast US exams Be familiar with the basic physical principles & limitations of US technology Be familiar with alternative & complimentary imaging & diagnostic procedures Be capable of correlating with mammography and other procedures

ACR Breast Ultrasound Accreditation: Physician Qualifications All physicians who supervise, perform &/or interpret breast ultrasound exams must (cont): Have thorough understanding of US technology, power output, equipment calibration and safety Be able to demonstrate familiarity with breast anatomy, physiology and pathology Be familiar with interpretation & documentation in accordance with the ACR Practice Guideline for Communication of Diagnostic Imaging Findings

ACR Breast Ultrasound Accreditation: Additional Physician Qualifications* * www.acr.org

ACR Ultrasound-Guided Breast Biopsy Accreditation: Physician Qualifications* * www.acr.org

ACR Breast Ultrasound Accreditation: Technologist Qualifications* * www.acr.org

ACR Breast Ultrasound Accreditation: Technologist Qualifications* Physician not required to be present during breast US performed by ARDMS or ARRT techs with certification in breast US Physician must be in dept. during breast US exams performed by ARRT techs without advance registry in breast US Ultimately, physician responsible for appropriate images and interpretation * www.acr.org

ACR Breast Ultrasound Accreditation: Equipment* High resolution, real time, linear arrays Operating at a center frequency of at least 10 MHz and preferably higher (highest frequency capable of adequate penetration to the depth of interest should be used) Capable of electronic focal zone(s) adjustment * www.acr.org

ACR Breast Ultrasound Accreditation: Quality Control* The following QC should be performed as recommended in the ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Real Time US Equipment: * www.acr.org

ACR Ultrasound-Guided Breast Biopsy Accreditation Module: Outcome Data* Total # procedures Total # CA s found Total # benign lesions Total # repeat bx s, reason & type of bx Insufficient sample Discordance Celllular atypia, radial scar other Complications by type of bx (ie CNB, FNAC): Hematoma, infection, pneumothorax * www.acr.org

ACR Ultrasound-Guided Breast Biopsy Accreditation Module: Biopsy Report* ACR strongly recommends the biopsy report include: Pathology results Imaging/pathologic concordance Follow-up recommendations based on pathology results * www.acr.org

ACR Breast Ultrasound Accreditation: Exam Identification and Labeling* * www.acr.org

ACR Breast Ultrasound Accreditation: Accreditation Testing* Facilities should submit best work All images should be submitted on film or high-quality photographic paper FNAC only for cytology of a solid mass, not cyst aspiration * www.acr.org

ACR Breast Ultrasound Accreditation: Clinical Images* If cyst or mass not marked = failure Marking more than one will also result in failure Evaluation of the quality of mammogram is not part of the assessment * www.acr.org

ACR Ultrasound-Guided Breast Biopsy Accreditation Module: Clinical Images* Films submitted should demonstrate that physicians performing the procedure possess the skill necessary for appropriate needle positioning. Position of the needle relative to the solid mass must be easily identified on the prebiopsy and biopsy images. If mass is not marked or more than one mass marked will result in failure * www.acr.org

ACR Ultrasound-Guided Breast Biopsy Accreditation Module: Clinical Images* * www.acr.org

ACR Breast Ultrasound Accreditation: Fees* * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Overview* Evaluate & feedback of facility s: Staff qualifications Equipment QC & QA Accuracy of needle placement Image quality & dose Clinical & phantom images Currently exempt from MQSA regulations, but standards are consistent for possible future regulatory inclusion * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Physician Qualifications* Interpreting Physician Collaborative Setting Setting in which both radiologists and surgeons conduct stereotactic breast biopsy procedure. Both physicians have joint responsibility for: Patient selection Quality assurance including medical audit Radiologist responsible for: Mammographic interpretation Oversight of all QC & QA Supervision of the radiologic technologist & physicist Radiologist must be qualified under MQSA * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Physician Qualifications* Interpreting Physician Collaborative Setting * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Physician Qualifications* Interpreting Physician Independent Setting Setting in which either radiologist or other physician conduct stereotactic breast biopsy procedure. The physician s responsibilities include: Patient selection (including documentation of correlative clinical breast exam) Quality assurance including medical audit Oversight of all QC Supervision of the radiologic technologist & physicist Post-biopsy management of the patient Radiologist also responsible for: Mammographic interpretation Documentation of correlative breast exam Referring patient to surgeon for follow-up of indicated lesions Radiologist must be qualified under MQSA

ACR Stereotactic Breast Biopsy Accreditation: Physician Qualifications* * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Technologist Qualifications* * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Medical Physicist* * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Equipment* -Specifically designed dedicated stereotactic breast biopsy units - Mammographic units using a specially designed add-on device for breast biopsy - Mammographic units exclusively using lateral arm devices, but only if the needle can be seen in relation to the lesion in 2 views. * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Quality Control* - 1999 ACR Stereotactic Breast Biopsy Quality Control Manual * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Quality Control* * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Outcome Data* Total # procedures Total # CA s found Total # benign lesions Total # repeat bx s, reason & type of bx Insufficient sample Discordance Celllular atypia, radial scar other Complications by type of bx (ie CNB, FNAC): Hematoma, infection, other * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Clinical Images* Facility must submit: One calcification case that demonstrates accurate needle placement The case s corresponding mammograms (high quality copies are acceptable) Calcifications must be identified on both the mammograms and all biopsy images Submitted images should demonstrate that physician possesses the skills necessary for appropriate needle biopsy Lead interpreting physician must review and approve clinical images * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Image Identification* * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Phantom Image & Dose* * www.acr.org

ACR Stereotactic Breast Biopsy Accreditation: Fees* * www.acr.org

ACR Breast MRI Accreditation: Overview* Evaluate & feedback of facility s: Staff qualifications Equipment QC & QA MR safety policies Image quality Clinical & phantom images * www.acr.org

ACR Breast MRI Accreditation: Overview* Facilities performing breast MRI must have the capacity to perform mammographic correlation, directed breast US, and MRIguided intervention OR create a referral arrangement with a cooperating facility that could provide these services. Recommend that the cooperating facility be accredited by the ACR in breast MRI. * www.acr.org

Medicare Improvement for Patients and Providers Act (MIPPA) 2008 All facilities that bill for advanced diagnostic imaging services under technical component of part B Medicare must be accredited by January 1, 2012 to qualify for Medicare reimbursement Affects providers of MRI, CT, PET and nuclear medicine for outpatient Medicare beneficiaries

Medicare Improvement for Patients and Providers Act (MIPPA) 2008 Each facility must: have a process for all patients to obtain copies of their records and images that is HIPAA compliant. Have a procedure for documenting the qualifications of facility s personnel from the primary source when appropriate for licenses & certification. Make publically available a notification for patients, family members or consumers that they may file a written complaint with the ACR

ACR Breast MRI Accreditation: Physician Qualifications* Interpreting Physician: Must have knowledge & expertise in breast disease and breast imaging diagnosis. The physician s responsibilities include: 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 Generating official interpretations (final reports) Assurring the quality of both the images & interpretations All physicians supervising and/or interpreting breast MRI exams must meet minimum criteria

ACR Breast MRI Accreditation: Physician Qualifications* Interpreting Physician: Initial Qualifications:» Board Certified Certification in Radiology or Diagnostic Radiology by the ABR, AOBR or Royal College of Physicians & Surgeons of Canada» AND If board certified before 2008, must also meet 1 of the following: Oversight, interpretation and reporting of 150 breast MRI exams in past 36 mos or Interpretation and reporting of 100 breast MRI exams in a supervised situation» AND 15 hours of Cat. 1 CME in Breast MRI» OR Not Board Certified Completion of an ACGME or AOA approved diagnostic radiology residency Interpretation and reporting of 100 breast MRI exams in the last 36 months in a supervised setting, and 15 hours of Category 1 CME in MRI (including clinical applications of MRI in breast imaging, MRI artifacts, safety, and instrumentation

ACR Breast MRI Accreditation: Physician Qualifications* Interpreting Physician: Continuing Qualifications: Upon renewal, 75 breast MRI exams in the prior 36 months* Must meet one of the following: 1. MOC requirements for the ABR 2. Completes 150 hours (including 75 hours Category 1 CME) in the prior 36 months 3. Completes 15 hours CME (half of which is Cat 1) in the prior 36 months specific to the imaging modality or organ system.

ACR Breast MRI Accreditation : Technologist Qualifications* Initial Qualifications: -Registered in MRI by: -American Registry of Radiologic Technologists (ARRT), or -American Registry of MRI Technologists (ARMRIT), or -Canadian Association of Medical Radiation Technologists (CAMRT) OR -Registered in radiography by 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 (eg. ARDMS or NMTCB), and -6 months supervised clinical MRI scanning experience AND Licensure in the state in which he/she practices AND Supervised experience in breast MRI, and Supervised experience in the intravenous administration of MR contrast (if administered by tech) * www.acr.org

ACR Breast MRI Accreditation: Technologist Qualifications* Continuing Qualifications: - Upon renewal, 50 breast MRI exams in the prior 24 months* - Continuing education: 1. Registered technologists - In compliance with 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 2. 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 technoligst s ACR accredited clinical practice 3. 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 technoligst s ACR accredited clinical practice

ACR Breast MRI Accreditation: Medical Physicist* * www.acr.org

ACR Breast MRI Accreditation: Medical Physicist or MR Scientist* In addition, must: - Be familiar with MRI safety for patients, personnel, and the public; the FDA s guidance for MR diagnostic devices; and other regulations pertaining to the performance of the equipment - Be knowledgeable in the field of MR physics and familiar with MRI technology, including function, clinical uses, and performance specifications, 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 CE programs of sufficient frequency to ensure familiarity with current concepts, equipment and procedures. Is responsible for all surveys of the breast MRI equipment. * www.acr.org

ACR Breast MRI Accreditation: Equipment* No minimum requirement for field strength. Must have: - dedicate, bilateral breast coil - 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 **Must have equipment to perform mammographic correlation, directed breast ultrasound, and MRI-guided intervention OR, referral arrangement with and ACR accredited breast imaging facility * www.acr.org

ACR Breast MRI Accreditation: Quality Control* 2004 ACR Magnetic Resonance Imaging Quality Control Manual * www.acr.org

Breast MRI Technologist s QC

ACR Breast MRI Accreditation Quality Assurance Accuracy of interpretation Complications and adverse events Medical outcomes audit program Reporting MRI BI-RADS Accreditation Testing Clinical Images * www.acr.org

ACR Breast MRI Accreditation Clinical Images : -submit 2 bilateral breast MRI cases from different patients: 1. Known, enhancing, biopsy-proven carcinoma 2. BI-RADS category 1 or 2 -All images of a case from same patient to include localizer or scout and the following 4 sequences:

ACR Practice Guidelines and Technical Standards For additional information & references: www.acr.org

BI-RADS 5 TH EDITION Assessment categories and recommendations Most notably, the management recommendations have been removed /disassociated from the BI-RADS assessment category

Assessment categories: 1 and 2 1= Negative 2= Benign finding Both have same management recommendation: routine mammography screening

Use category 1 when no specific findings are described in the report Use category 2 when at least one benign finding is described in the report May have benign findings and use category 1 if findings are not described in the report

Category 3 = probably benign Not used for indeterminate category Use for specific imaging findings known to have greater than essentially 0% but less than 2% likelihood of representing malignancy Only use this category after completion of a full diagnostic breast imaging examination, not on a screening mammogram or screening ultrasound

BI-RADS category 3: Probably benign Initial short interval follow up in 6 months Then short interval follow up in 6 months at time of annual exam Then follow up in 12 months at time of annual BUT still give the report an assessment of category 3 if mammographic or sonographic surveillance is ongoing

Biopsy of a probably benign lesion If there is patient or referring clinician concern about a lesion that is considered probably benign, still make the category BIRADS 3: probably benign but add a line that tissue diagnosis will be performed due to patient or referring clinician concern

BI-RADS category 4 Findings prompting breast interventional procedure, from aspiration to biopsy Optional to divide category into three subdivisions: 1. 4A: low suspicion for malignancy > 2% to </= 10% likelihood of malignancy 2. 4B: moderate suspicion for malignancy >10% to </= 50% likelihood of malignancy 3. 4C: high suspicion for malignancy > 50% to < 95% more malignant than benign Edition 4 stated consider biopsy and the 5 th Edition states in management biopsy should be performed in the absence of clinical contraindication

BI-RADS category 5 Highly suggestive of malignancy In past category was used for non palpable breast lesions that went straight to surgical excision. Today most lesions undergo percutaneous biopsy Current rational to use category 5: to identify lesions for which any nonmalignant percutaneous tissue diagnosis is automatically considered discordant

>/= 95% likelihood of malignancy Management: 4 th edition stated appropriate action should be take and 5 th edition states biopsy should be performed in the absence of clinical contraindication

BI-RADS category 6 Special circumstance when breast imaging is performed after a tissue diagnosis of malignancy but prior to complete surgical excision Examples: second opinions target lesion already biopsied or monitoring response to neo-adjuvant chemotherapy

Special cases regarding category 6: Post lumpectomy with positive resection margins and finding on imaging *** if positive margins and benign findings on mammography, it is BI-RADS 2 with additional sentence pathology report suggests possibility of residual tumor despite absence of mammographic correlate

Edition 4 stated Appropriate action should be taken and Edition 5 states surgical excision when clinically appropriate If there is a suspicious finding on the imaging study in addition to the known malignancy, then use category 4 or 5 Second opinions that require additional imaging work up should be category 0 Do not include category 6 in audit

BI-RADS category 0 Usually used in screening mammography or sonography 1. Additional imaging evaluation needed 2. Need previous exams for comparison if needed to make a final assessment 3. Technical repeat examination

When using category 0 to indicate need for prior exams, the facility needs to have in place tracking procedure to ensure that the patient will be recalled for imaging if films are not available in 30 days

Assessment and management for breast MRI Category 1 = negative Category 2 = benign; findings are described in the report Management: annual screening breast MRI and mammography in line with established guidelines for high risk screening

Category 3 = probably benign Evolving category Follow up of foci: if not considered BPE Follow up of masses: evaluate on morphology and kinetics and if considered benign may follow versus biopsy Follow up of NME: no, needs biopsy Interval follow up at 6, 12, 24 months

Category 4: suspicious and recommend tissue sampling - Not subdivided into 4A, 4B, 4C Category 5: highly suggestive of malignancy - Tissue sampling is recommended Category 6: Known biopsy proven malignancy

BREAST DENSITY (composition) breast composition measurement is about the volume of attenuating tissue in the breast 1. Removed the old area-based percentage thresholds 2. Switched from using numbers for the categories to letters

a. The breasts are almost entirely fatty b. There are scattered areas of fibroglandular density c. The breasts are heterogeneously dense, which may obscure small masses d. The breasts are extremely dense, which lowers the sensitivity of mammography