Stereotactic Breast Procedures Facility Accreditation
This program is designed to meet the needs of individual surgeons who either own or are directly responsible for the equipment and the personnel involved in stereotactic breast biopsy procedures in one or more facilities. Individual surgeons performing stereotactic breast biopsy procedures in a stereotactic facility accredited program must either be certified or be in the process of certification by the Society in stereotactic breast procedures. It is not necessary for surgeons who perform stereotactic procedures to apply for this facility accreditation program if the stereotactic procedures are being performed in a facility not owned or under direct control and supervision of the surgeon. As in the Society’s Stereotactic Breast Procedure Certification Program, this program is based, in part, on the principles for the proper performance of stereotactic breast procedures as outlined in the Society's Performance and Practice Guidelines for Stereotactic Breast Procedures. Note: Membership in the Society is not required for facility accreditation.
Equipment used in the performance of stereotactic breast procedures must be FDA approved. Information should be provided regarding the manufacturer, model, date of manufacture, and date placed into service. Maintenance records must be kept on site and are subjected to on-site inspections. Radiation-producing equipment must meet all state and local requirements. Documentation of meeting these requirements should be provided. If a facility and/or equipment are outside FDA jurisdiction, they must comply with all of the standards for the performance of stereotactic procedures.
Surgeons performing stereotactic breast biopsy procedures in an accredited facility must either be certified by the Society or be proctored by a certified surgeon.
- Qualified to perform mammography under MQSA
- Three Category A CEUs in stereotactic breast procedures
- Participated in five stereotactic breast biopsy procedures under supervision of a qualified physician or technologist
Twelve stereotactic breast procedures per year and three CEUs in stereotactic procedures every 3 years. Technologists must be MQSA qualified.
- Qualified to perform mammography surveys under MQSA
- Performed one hands-on stereotactic breast biopsy survey under a qualified medical physicist or at least three independent surveys prior to 6/1/97
- One stereotactic breast biopsy unit physics survey per year
- Three CEUs in stereotactic breast biopsy every 3 years
*Medical physicists must be currently qualified under MQSA.
The medical physicists and the technologists must meet specific survey and quality control measures as outlined in the Accreditation Application. These are in keeping with the good practices of these individuals as spelled out by the American College of Radiology.
Outcome data from the past 12 months, clinical case experience, documentation for specific cases, appropriate case reports, and the submission of clinical images for two cases must accompany the application.
Facilities must recertify every 3 years.
There is a $100 add-on fee for this program.