Editor's note: Following review and approval by both the Board of Regents of the American College of Surgeons (ACS) and the Board of Chancellors of the American College of Radiology (ACR), the guidelines document Physician Qualifications for Stereotactic Breast Biopsy was published in the September 1997 issue of the Bulletin of the American College of Surgeons. Several ACS Fellows subsequently contacted the College to suggest revisions to the document that significantly clarify the requirements and delineate the additional clinical skills that should be required for radiologists practicing independently.
The College agreed to incorporate the proposed changes in the guidelines document and to submit the revised statement to the ACS Board of Regents and the ACR Board of Chancellors for their consideration and review. The revised document was approved by both of those bodies in February of this year and is presented here in its entirety. Changes to the text are printed in italics.
The American College of Radiology and the American College of Surgeons have held discussions regarding the qualifications for physicians performing stereotactic breast biopsy. The working group has determined that there seems to be two major models of practice for the performance of stereotactic breast biopsy. The American College of Radiology and the American College of Surgeons believe that each model provides the patient with certain unique benefits.
- In a collaborative practice, the patient derives the benefit of consultation and collaboration from the radiologist and surgeon (or other physician) working together.
- Where a radiologist or surgeon (or other physician) are practicing independently, the expertise in the diagnosis and management of breast disease of an individual physician may provide the patient with an equivalent benefit.
- In a situation where a radiologist and surgeon (or other physician) practice collaboratively, patient selection and quality assurance including medical audit are the joint responsibility of the radiologist and surgeon (or other physician). Either qualified physicians may perform the actual procedure.
- Requirements for the radiologist in a collaborative setting:
- Initial training and qualifications:
- Be qualified under MQSA to be an interpreting physician.
- Have performed at least 12 stereotactic breast biopsies, or at least three hands-on stereotactic breast biopsy procedures under a physician who is qualified to interpret mammography under MQSA and has performed at least 24 stereotactic breast biopsies.
- Have at least three hours of Category I CME in stereotactic breast biopsy.
- Be responsible for mammographic interpretation, and be experienced in recommendations for biopsy and lesion identification at time of biopsy.
- Be responsible for oversight of all quality control and quality assurance activities.
- Be responsible for the supervision of the radiologic technologist and the medical physicist.
- Maintenance of proficiency and CME requirements:
- Perform at least 12 stereotactic breast biopsies per year or requalify as specified in A.1.
- Obtain at least three hours of Category I CME in stereotactic breast biopsy every three years.
- Requirements for the surgeon (or other physician) in a collaborative setting:
- Initial training and qualifications:
- Have at least three hours of Category I CME in stereotactic breast biopsy which should include instruction in imaging triangulation for lesion location.
- Have performed at least 12 stereotactic breast biopsies, or at least three hands-on stereotactic breast biopsy procedures under a physician who is qualified to interpret mammography under MQSA and has performed at least 24 stereotactic breast biopsies.
- Be experienced in post-biopsy management of the patient.
- Maintenance of proficiency and CME requirements:
- Perform at least 12 stereotactic breast biopsies per year or requalify as specified in B.1.
- Obtain at least three hours of Category I CME in stereotactic breast biopsy every three years.
- In the situation where a radiologist or surgeon (or other physician) practices stereotactic breast biopsy independently, the physician is required to:
- Requirements for a radiologist practicing independently:
- Initial training and qualifications:
- Be fully qualified as an interpreting physician under MQSA.
- Initially, have at least three hours of Category I CME in stereotactic breast biopsy.
- Initially, obtain at least 15 hours of documented CME in breast imaging including pathophysiology of benign and malignant breast disease as well as clinical breast examinations.
- Have performed at least 12 stereotactic breast biopsies OR at least three hands-on stereotactic breast biopsy procedures under a physician who is qualified to interpret mammography under MQSA and has performed at least 24 stereotactic breast biopsies Be responsible for mammographic interpretation.
- Be responsible for patient selection including documentation of correlative clinical breast examination.
- Be responsible for quality assurance activities including medical audit (tracking of number of biopsies done, cancers found, benign lesions, biopsies needing repeat, and complications).
- Be responsible for oversight of all quality control.
- Be responsible for the supervision of the radiologic technologist and medical physicist.
- Be responsible for post-biopsy management of the patient which may include referral to a surgeon for follow-up on certain lesions.
- Maintenance of proficiency and CME requirements. The radiologist is required to:
- Perform at least 12 stereotactic breast biopsies per year or requalify as specified in A.1.
- Obtain at least three hours of Category I CME in stereotactic breast biopsy every three years which should include post-biopsy management of the patient
- Obtain at least 15 hours of Category I CME in breast imaging including pathophysiology of benign and malignant diseases of the breast every three years as required for interpretation of mammography by MQSA.
- In the situation where a surgeon (or other physician) practices stereotactic breast biopsy independently, the surgeon (or other physician) is required to:
- Initial training and qualifications:
- Have evaluated* at least 480 mammograms every two years in consultation with a physician who is qualified to interpret mammograms under MQSA.
- Initially, have at least 15 hours of Category I CME in stereotactic breast imaging and biopsy OR three years experience having performed at least 36 stereotactic breast biopsies.
- Have four hours of Category 1 CME in medical radiation physics.
- Have performed at least 12 stereotactic breast biopsies OR at least three hands-on stereotactic breast biopsy procedures under a physician who is qualified to interpret mammography under MQSA and has performed at least 24 stereotactic breast biopsies.**
- Be responsible for patient selection.
- Be responsible for quality assurance activities including medical audit (tracking of number of biopsies done, cancers found, benign lesions, biopsies needing repeat, and complications).
- Be responsible for oversight of all quality control.
- Be responsible for the supervision of the radiologic technologist and the medical physicist.
- Be responsible for post-biopsy management of the patient.
- Maintenance of proficiency and CME requirements: The surgeon (or other physician) is required to:
- Continue to evaluate at least 480 mammograms every 2 years in consultation with a physician who is qualified to interpret mammograms under MQSA.
- Perform at least 12 stereotactic breast biopsies per year or requalify as specified in B.1.
- Obtain at least three hours of Category I CME in stereotactic breast biopsy every three years.
A surgeon (physician) who is not qualified to interpret mammograms under MQSA may be qualified as instructor/ trainer for stereotactic needle biopsy if he/she meets the following criteria:
- At least 50 percent of his or her professional time is devoted to breast practice; consulting/advising patients with breast disease and to performing diagnostic and therapeutic procedures, including review of 480 mammograms a year either independently or in consultation with an MQSA-qualified radiologist.
- Should have taken formal stereotactic training course(s) for at least 24 hours in Category 1 CME including four hours of Category I instruction in radiation physics.
- Should have two years experience in stereotactic biopsy, having performed an average of 50 procedures per annum.
- To maintain records of stereotactic needle biopsy procedures including complications, pathologic results, and follow-up of patients with either mammography or open biopsy to establish false negative and positive predictive value in his or her practice.
- To publish and make related presentations at scientific meetings and to be recognized by his or her peers as a teacher.
- Continue to meet all other continuing requirements including:
- Be responsible for oversight of all quality control and quality assurance, if practicing independently.
- Be responsible for supervision of the radiologic technologist and medical physicist staff, if practicing independently.
- Be responsible for post-biopsy management of patient.
- Perform at least 12 stereotactic breast biopsies per year and obtain three hours of Category I CME every three years.
* Evaluation means review of the mammographic films in direct consultation with an MQSA qualified physician and/or independent review of mammograms with the authenticated mammographic report.
** Or under a non-MQSA qualified surgeon (physician) who meets the criteria as an instructor/trainer for stereotactic needle biopsy as outlined on page 33.
Reprinted from Bulletin of the American College of Surgeons
Vol.83, No. 05, May 1998
