Personnel Qualifications
Interpreting Physician Personnel Qualifications [1]
Must meet country’s qualification requirements
Only qualified physicians may independently perform stereotactic breast biopsy procedures at facilities. Physician Assistants or Radiologist’s Assistant cannot perform stereotactic breast biopsies without a qualified physician being in the room at the time of the biopsy procedure.
Interpreting physician’s responsibilities include:
Patient selection (including documentation of correlative clinical breast exams)
Quality assurance including the medical audit (tracking of the number of biopsies done, cancers found, benign lesions, biopsies needing repeat, and complications)
Oversight of all quality control
Supervision of the radiologic technologist and the medical physicist
Post-biopsy management of the patient
A radiologist practicing in an independent setting is also responsible for:
Mammographic interpretation
Documentation of correlative breast examinations
Referring patients to a surgeon for follow-up on certain lesions
Radiologists interpreting stereo exams must meet one of the following Continuing Experience requirements:
Currently meets Maintenance of Certification (MOC) requirements for the American Board of Radiology (ABR) or the Osteopathic Continuous Certification (OCC) requirements for the American Osteopathic Board of Radiology (AOBR)
36 image-guided breast biopsies in prior 36 months (at least 9 of these must be stereotactic breast biopsies)
Other physicians interpreting stereo exams must meet both of the following Continuing Experience requirements:
36 image-guided breast biopsies in the prior 36 months (at least 9 of these must be stereotactic breast biopsies)
Evaluate [2] 720 mammograms in the prior 36 months in consultation with qualified physician
Physicians who have not maintained continuing experience may requalify by performing 3 hands-on stereotactic breast biopsy procedures under a qualified physician.
- All physicians interpreting stereo exams must meet one of the following Continuing Education requirements:
- Currently meets MOC requirements for the ABR or the OCC requirements for the AOBR
- Completes 150 hours CME (75 hours must be Cat 1) in the prior 36 months pertinent to the physician’s practice patterns (See ACR Practice Parameter for Continuing Medical Education)
- Completes 15 hours CME (half must be Cat 1) in the prior 36 months specific to the imaging modality or organ system
Medical Physicist Personnel Qualifications
Must meet country’s qualification requirements
Must perform 2 stereotactic breast biopsy unit surveys in the prior 24 months (physicists who have not maintained their continuing experience may requalify by performing 1 hands-on stereotactic breast biopsy physics survey under a qualified medical physicist)
Must obtain 3 CEUs in stereotactic breast biopsy in the prior 36 months
Technologist Personnel Qualifications
Must have 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
Stereotactic Breast Biopsy Equipment Quality Control (QC)
Documentation of quality control (QC) is required. Detailed instructions for each of the tests listed below are contained in the 1999 ACR Stereotactic Breast Biopsy Quality Control Manual.
Acceptance Testing
Initial performance testing should be performed upon installation of new stereotactic breast biopsy equipment. This testing should be more comprehensive than periodic performance and compliance testing and should be consistent with current acceptance testing practices.
Annual Medical Physicist Survey
Quality Control Tests
A QC program must be implemented for all units and should be established with the assistance of a medical physicist. The radiologic technologist must perform the QC tests listed in the table below at the specified minimum frequencies. The medical physicist should identify the person responsible for performing the tests and may choose to increase the frequency of testing based on the facility and usage. If any QC parameter being monitored falls outside of the control limits, corrective action should be taken. A medical physicist should be available to assist in prescribing corrective actions for unresolved problems.
Radiologic Technologist's QC | ||
QC Test | Description | Frequency |
Localization Accuracy Test | Verifies system alignment and performance (procedure varies by manufacturer and system type) | Daily before patient exams |
Darkroom Cleanliness (N/A if digital used) | Minimizes artifacts on film images by maintaining the cleanest possible conditions in the darkroom | Daily |
Processor QC (N/A if digital used) | Ensures consistent performance of the film processor | Daily |
Phantom Images | Ensures that film density, contrast, uniformity, and image quality of the x-ray imaging system are optimal | Weekly |
Screen Cleanliness (N/A if digital used) | Ensures that cassettes and screens are free of dust and dirt particles that may degrade image quality or mimic calcifications | Weekly |
View boxes and Viewing Conditions (if film used) | Ensures that the view boxes and viewing conditions are optimized and maintained at optimal levels | Weekly |
Hardcopy Output Quality (if hardcopy produced from digital data) | Ensures that the quality of hardcopy output is consistent over time and matches the gray scales presented on the CRT monitor | Monthly |
Visual checklist | Ensures that the mammography x-ray system and, if applicable, the digital imaging system are working properly and that the mechanical rigidity and stability of the system are optimal | Monthly |
Analysis of Fixer Retention in Film (N/A if digital used) | Determines the quantity of residual fixer (hypo) in processed film as an indicator of keeping quality | Quarterly |
Compression | Ensures that the x-ray imaging system can provide adequate compression in the manual and automatic powered mode | Semiannually |
Repeat Analysis | Determines the number and causes of repeated patient exposures and identifies ways to improve efficiency, reduce patient breast dose, and cut costs | Semiannually |
Screen-Film Contact (N/A if digital used) | Ensures that optimum contact is maintained between the screen and the film in each cassette | Semiannually |
Darkroom Fog (N/A if digital used) | Ensures that darkroom safelights and other light sources inside and outside of the darkroom do not fog film | Semiannually |
Zero Alignment Test (if required by manufacturer) | Verifies that zero coordinate is accurate | Before each patient |
Additional tests if required by manufacturer | As required by manufacturer | |
Preventive Maintenance
Preventive maintenance should be scheduled, performed, and documented by a qualified service engineer on a regular basis. Service performed to correct system deficiencies should also be documented and service records maintained by the facility.
Clinical Image Evaluation and Labeling
Facility’s must review 1 typical clinical examination and attest to meeting the ACR clinical image quality and labeling requirements found below.
Exam Requirements
Correlating Mammogram
A 2-view mammogram (CC and MLO/ML/LM)
Performed within 60 days prior to the stereotactic procedure (Do not review post-procedure images)
Includes the entire breast with the calcifications to be biopsied circled on each image
The mammogram can be from an outside facility
2D and 2D synthesized images are acceptable to review, however, individual slices from tomosynthesis are acceptable only in addition to the CC/ML/MLO views
Additional images (i.e., XCCL, spot view or magnification views) may be reviewed in addition to, but not instead of, the 2-view mammogram
Stereo Pair
The images should demonstrate that physicians possess the skills necessary for appropriate needle positioning during these procedures.
Although valuable for some calcifications, “target-on-scout” images are not acceptable for
the recognition because one cannot assess the needle position on 2 views.
Vacuum-Suction biopsy probe (or other FDA-Approved Core Biopsy Device
Pre-Fire stereo pair demonstrating needle positioning for tissue acquisition; the calcifications must be visible on both stereotactic views.
OR
Post-fire stereo pair demonstrating needle positioning for tissue acquisition; the calcifications MUST be visible on both stereotactic views.
Gun-Needle Biopsy:
A Pre-Fire stereo pair demonstrating needle positioning; the calcifications must be visible on both stereotactic views.
Specimen Image
A specimen image demonstrating calcium.
Facilities utilizing the Brevera specimen system should select the single specimen core with the most representative calcifications for review.
Exam Identification and Labeling
Each image should be clearly and permanently labeled (a permanent sticker label is acceptable for film) with the information below:
Patient’s first and last names (required)
Identification number and/or date of birth (required)
Examination date (required)
Facility name
Facility location (city, state and zip)
Designation of left or right breast (required)
Annotation of mammographic view (e.g., CC, MLO/ML/LM)
Technologist’s identification number or initials
Physician Quality Assurance
Facilities must conduct ongoing medical audits of stereotactically-guided breast biopsy procedures to evaluate and improve performance. At a minimum, the physician should be able to review the number of procedures done by type, the number of cancers diagnosed and the number of complications requiring treatment.
Total number of procedures
Total number of cancers found
Total number of benign lesions
Total number of stereotactic biopsies needing repeat biopsy, categorized by reason and type of biopsy (i.e., CNB, FNAC)
Insufficient Sample
Total number of cases
Number with repeat biopsy performed by core
Number with repeat biopsy performed by excision
Final pathology results
Discordance
Total number of cases
Number with repeat biopsy performed by core
Number with repeat biopsy performed by excision
Final pathology results
Cellular Atypia, Radial Scar
Total number of cellular atypia cases
Total number of radial scar cases (CNB only)
Number with repeat biopsy performed by core
Number with repeat biopsy performed by excision
Final pathology results
Other
Total number of cases
Number with repeat biopsy performed by core
Number with repeat biopsy performed by excision
Final pathology results
Complications requiring treatment, categorized by type of biopsy (i.e., CNB, FNAC)
Total number
Number with hematoma (requiring intervention)
Number with infections requiring treatment
Number of other complications
Footnotes
[1] Occasional readers who are providing imaging services to and for the practice readers are not required to meet continuing experience requirements. However, the reads of all occasional readers combined should not exceed 5% of the total volume of reads per practice and per modality. There must be an active written review process in place at the institution for occasional readers based on each institution’s credentialing requirements.
[2] In the context of initial and continuing experience, evaluation means review of the mammographic images in direct consultation with a qualified interpreting physician and/or independent review of mammograms with the authenticated mammographic report.