Breast Ultrasound Facility Accreditation

The Society’s optional Breast Ultrasound Facility Accreditation Program has been approved by the Board of Directors, and will be available to those facilities that wish to apply. This program is designed to ensure that facilities receiving such accreditation have met the applicable requirements regarding personnel (physicians, ultrasound technologists, physician assistants, nurse practitioners, and nurses), equipment, quality control and quality assurance programs, and accuracy of examinations and procedures being performed. Note: Membership in the Society is not required for facility accreditation.

Personnel Requirements

To become accredited:

• At least 1 surgeon in the facility must be certified in breast ultrasound by the Society and must be responsible for the overall ultrasound program.
• In addition, all physicians and allied health personnel who perform breast ultrasound must be certified or actively working toward certification under the supervision of the surgeon certified by the Society. Certification by the Society is appropriate for surgeons and by the American Registry for Diagnostic Medical Sonographers (ARDMS) for all other allied health personnel.
• All physicians, physician assistants, nurse practitioners, technologists, nurses, or other allied health care professionals who work in the facility must be listed on the application, indicating whether they perform breast ultrasound. Those who do perform breast ultrasound must provide evidence of their certification or a statement reflecting what they are doing to obtain certification. Annual volumes of diagnostic and interventional breast ultrasound must be listed for each person. Each individual who is not yet certified must provide a detailed list of CME activities.

To maintain accreditation:

• All personnel who are working toward certification must become certified within 3 years from the time accreditation is granted to the facility.
• Physicians and allied health personnel who join the practice after accreditation is granted will have 3 years from the time they join the practice to become certified.
• If the responsible surgeon moves to a different practice location, he/she remains certified by the Society for the duration of the certification or recertification, but further application is required in order to maintain accreditation for the former facility or to obtain accreditation for the new practice facility.
• Facilities must be re-accredited every 3 years.

Case Submission Requirements

• If an application for facility accreditation is received within 2 years of the time of individual certification or recertification, no additional case submissions are required.
• For practices at which an individual has been certified or recertified for more than 2 but less than 3 years, two additional case submissions (in the same format as individual recertification) are required.
• If it has been 3 or more years since the individual was certified or recertified, it is necessary to submit 10 cases.

Equipment Requirements

• A list of ultrasound equipment used in any location (hospital, ambulatory surgery center, office, etc.), along with documentation of proper inspection and maintenance by the manufacturer, a qualified engineer, or a medical physicist must be submitted. Note: The Society must be notified in the event of any equipment or maintenance changes that could reasonably be expected to adversely affect the quality of images obtained.
• The facility policy on transducer cleaning and on the prevention of transmission of infectious diseases must be submitted, along with a statement as to whether the facility is in compliance with all regulations of the Occupational Safety & Health Administration or the Accreditation Association for Ambulatory Health Care.

Quality Control and Assurance

Each practice must record and track quality assurance indicators outlined below. The records should be updated at least every 6 months, and must be submitted as a part of the re-accreditation process 5 years after accreditation is granted. The Society reserves the right to randomly audit practices for compliance during the accreditation period at any time prior to application for recertification. Data must be recorded and tracked for all ultrasound-guided biopsies and aspirations except for simple cysts in which the fluid is discarded. Data that must be tracked includes the following:

1. Date of procedure
2. Prebiopsy diagnosis
3. Biopsy histology
4. Concordant or discordant with imaging findings?
5. Date of follow-up operation, if any
6. Surgical pathology, if applicable
7. Concordant or discordant with biopsy pathology?
8. For patients who did not undergo surgical excision, the findings on sonographic, mammographic, (or both) follow-up 6 to 18 months postbiopsy.
9. Complications, including hematoma, infection, pneumothorax
10. Summary data, including:
    • Total number of ultrasound-guided biopsies done
    • Number (and percent) of patients with invasive cancers or DCIS
    • Number (and percent) of patients with LCIS or atypical hyperplasia
    • Number (and percent) of patients in which biopsy was discordant with imaging findings
    • Number (and percent) of patients in which surgical pathology was discordant with biopsy pathology
    • Number (and percent) of patients whose diagnosis was upgraded on surgical pathology
    • Number (and percent) of patients who developed ipsilateral invasive or noninvasive cancer within 12 months of a benign ultrasound-guided biopsy
    • Number (and percent) of patients who had complications

Fee

A $100 review fee is due with submission of a completed application.

To Begin the Process

Your first step to apply accreditation is to complete the Breast Ultrasound Facility Accreditation Program Order Form. Please return your completed form to mgirard@breastsurgeons.org.

Program Goals

The Ultrasound Facility Accreditation Program was developed in order to provide surgeons utilizing breast ultrasound in their practices a method to demonstrate that the ultrasound technology employed, and the facility procedures meet accepted standards of proper performance and safety. This is an optional program, but one the Society believes that surgeons employing breast ultrasound should achieve.

The Society believes it is important that surgeons be given a process that allows them to demonstrate to their patients, regulatory bodies, and payers that the accepted standards for the technology and the facility have been met.