Revision History
Radiologists must be currently qualified as interpreting physicians under MQSA. The specific qualifications required for the physician depend on the setting in which he or she practices (i.e., “collaborative” or “independent”).
Should different staff (e.g. a radiology practice and a surgical practice) within the same site wish to accredit differently (i.e. some as a collaborative setting and some as an independent setting), those practices would need to accredit as 2 separate facilities with 2 designated supervising physicians.
Please note that only qualified physicians may independently perform stereotactic breast biopsy procedures at facilities accredited by the ACR. 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.
Collaborative Settings
A collaborative setting is one where both radiologists and surgeons (or other physicians) conduct stereotactic breast biopsy procedures using the accredited unit. The physicians should be present at the appropriate time or immediately available through PACS to review images during the procedure. Both radiologists and surgeons (or other physicians) have joint responsibility for:
Patient selection
Quality assurance including the medical audit (tracking of the number of biopsies done, cancers found, benign lesions, biopsies needing repeat, and complications)
The radiologist is responsible for:
Mammographic interpretation
Oversight of all quality control and quality assurance
Supervision of the radiologic technologist and the medical physicist
All physicians supervising and conducting stereotactic breast biopsies in a collaborative setting must meet the following minimum criteria:
Initial Qualifications | |
Radiologist | Other Physician |
All of these:
| All of these:
|
Continuing Experience | |
Upon renewal, physicians reading stereotactic breast biopsies must meet one of the following:
| |
Continuing Education | |
Upon renewal, must meet one of the following:
Although continuing education specific to stereotactic breast biopsy is required for accreditation, the FDA allows these credits to count towards the continuing education requirements for MQSA. Further information is available from the FDA Policy Guidance Help System. For additional information on continuing education, please see our related article. | |
Independent Settings
An independent setting is one where either radiologists or other physicians (typically surgeons) conduct stereotactic breast biopsies using the accredited unit. In an independent setting, the 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
All physicians supervising and conducting stereotactic breast biopsies in an independent setting must meet the following minimum criteria:
Initial Qualifications | |
Radiologist | Other Physician |
All of these:
| All of these:
|
Continuing Experience | |
Upon renewal, physicians reading stereotactic breast biopsies must meet one of the following:
| Both of these:
|
Physicians who have not maintained continuing experience may requalify by performing 3 hands-on stereotactic breast biopsy procedures under a qualified physician.For additional information on continuing experience, please see our related article. | |
Continuing Education | |
Upon renewal, must meet one of the following:
Although continuing education specific to stereotactic breast biopsy is required for accreditation, the FDA allows these credits to count towards the continuing education requirements for MQSA. Further information is available from the FDA Policy Guidance Help System. For additional information on continuing education, please see our related article. | |
*In the context of initial and continuing experience, evaluation means review of the mammographic films in direct consultation with an MQSA-qualified interpreting physician and/or independent review of mammograms with the authenticated mammographic report.
For training purposes, a qualified physician is one who is qualified to interpret mammography under MQSA and has performed at least 24 stereotactic breast biopsies. A physician who is not qualified to interpret mammograms under MQSA may be qualified as instructor/trainer for stereotactic breast biopsy by meeting the following criteria:
At least 50% of his or her professional time should be devoted to breast practice: consulting/advising patients with breast disease, performing diagnostic and therapeutic procedures (including reviewing 480 mammograms a year either independently or in consultation with an MQSA-qualified radiologist).
Completion of formal stereotactic training course(s) for at least 24 hours in Category 1 CME, including 4 hours of Category 1 instruction in radiation physics.
Minimum 2 years’ experience in stereotactic biopsy, having performed an average of 50 procedures a year.
Maintenance of records of stereotactic breast biopsy procedures, including complications, pathologic results, and follow-up of patients with either mammography or open biopsy to establish false negative and positive predictive values in his or her practice.
Publication and related presentations at scientific meetings; recognized by his or her peers as a teacher.
Continues to meet all other continuing requirements, including:
Being responsible for oversight of all quality control and quality assurance, if practicing independently
Being responsible for supervision of the radiologic technologist and medical physicist staff, if practicing independently.
Being responsible for post-biopsy management of patient.
Meeting the above continuing experience and continuing education requirements.
Training received in digital image receptors used for stereotactic biopsy can count toward the 8 hours of training specific to FFDM if the training is essentially the same as that being given for FFDM. For example, if the interpreting physician received training in the manipulation of stereotactic digital images, and the FFDM manipulation of images is essentially the same as with stereotactic, that training could count toward the 8 hours of training specific to FFDM. Because stereotactic breast biopsy systems with digital image receptors are currently excluded from MQSA regulation, experience with these systems cannot be used to meet the requirement of 8 hours of training specific to FFDM. See the FDA Policy Guidance Help System for more information.
Currently, there are no MQSA requirements for personnel performing interventional mammographic procedures. See the FDA Policy Guidance Help System for more information.
Revision History for this Article | ||
Date | Section | Description of Revision(s) |
12-12-19 | All | Article created; FAQs incorporated; No criteria changes |
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