 |
Physician qualifications for stereotactic breast biopsy
A topic of much discussion and controversy over the past several years
has been the issue of who is qualified to perform stereo-tactic breast biopsies.
Almost two years ago, a Joint Task Force of the American College of Surgeons
(ACS) and the American College of Radiology (ACR) began a dialogue on this
topic. David P. Winchester, MD, FACS, Medical Director, ACS Cancer Department,
and Lawrence W. Bassett, MD, Chair of the ACR Task Force on Breast Cancer,
co-chaired this effort. Several very positive outcomes now have been realized.
The first was a status report on ``Stereotactic Core-Needle Biopsy of the
Breast,'' which was published in the May/June 1997 issue of CA--Cancer Journal
for Clinicians. The College of American Pathologists also joined in this
effort. The report is based on a comprehensive review of the literature
and includes indications, contraindications, informed consent, specimen
handling, and management of indeterminate, atypical, or discordant lesions.
Also included are guidelines on communication of results, management, and
follow-up; quality assurance and quality improvement for those involved
in the performance of the procedure; and proper equipment monitoring.
The second outcome was an important agreement on Physician Qualifications
for Stereotactic Breast Biopsy. This document was finalized in early June
of this year and is based in part on the previously mentioned report and
the dialogue of many months on quality patient care. The document was reviewed
and approved by both the Board of Regents of the American College of Surgeons
and the ACR Board of Chancellors.
Stereotactic breast biopsy procedures will come under the provisions of
the Mammography Quality Standards Act of 1992 (MQSA) in the not-too-distant
future, so this document assumes even more importance as discussions commence
with the Food and Drug Administration. The physician qualifications are
printed here in their entirety.
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
seem 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.
I.
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, surgeon (or other
physician). The physicians should be present at the appropriate time during
their procedure.
A.
Requirements for the radiologist in a collaborative setting:
1.
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.
2.
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.
B.
Requirements for the surgeon (or other physician) in a collaborative setting:
1.
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 postbiopsy management of the patient.
2.
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.
II.
In the situation where a radiologist or surgeon (or other physician) practices
stereotactic breast biopsy independently, the physician is required to:
A.
Requirements for a radiologist practicing independently
1.
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 CME in breast imaging including benign
and malignant breast disease.
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.
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, which may include
referral to a surgeon for follow-up on certain lesions.
2.
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 postbiopsy management of the patient.
Obtain at least 15 hours of Category I CME in breast imaging, including
benign and malignant diseases of the breast every three years as required
for interpretation of mammography by MQSA.
B.
In the situation where a surgeon (or other physician) practices stereotactic
breast biopsy independently, the surgeon (or other physician) is required
to:
1.
Initial training and qualifications.
Have evaluated at least 480 mammograms per year in the prior 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 stereotacticbreast
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.
2.
Maintenance of proficiency and CME requirements. The surgeon (or other physician)
is required to:
Continue to evaluate at least 480 mammograms per year 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 an Instructor/Trainer for Stereotactic Needle Biopsy
if he/she meets the following criteria:
1. At least 50 percent of his or her professional time is devoted to breast
practice; consulting/ advising patients with breast disease and to perform
diagnostic and therapeutic procedures; for example, including review of
480 mammograms a year either independently or in consultation with an MQSA
qualified radiologist.
2. Should have taken formal stereotactic training course(s), including instruction
in radiation physics for at least 16 hours and preferably for at least 24
hours in Category 1 CME including four hours of Category I instruction in
radiation physics.
3. Should have two years experience in stereotactic biopsy having performed
an average of 50 procedures per annum.
4. 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.
5. To publish and make related presentations at scientific meetings and
to be recognized by his or her peers as a teacher.
6. 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.
________________
Bulletin of the American College of Surgeons
Vol. 82, No.9, September 1997
Advisory Council for General Surgery
Stereotactic breast biopsy:
An overview
This page and all contents are Copyright © 1996-2000
by the American College of Surgeons, Chicago, IL 60611-3211
|
|
