Stereotactic Breast Biopsy Accreditation Program

Introduction

The ACS Stereotactic Breast Biopsy Accreditation Program offers physicians the opportunity for peer review and evaluation of their facility's staff qualifications, equipment, quality control and quality assurance programs, image quality, and breast dose.

This voluntary program is directed by the Committee on Stereotactic Breast Biopsy Accreditation.

The impetus for the program came as a result of the concerns of radiologists, surgeons, other national medical organizations, the government, and the public that qualified personnel perform stereotactic breast biopsies using appropriate equipment to ensure that women receive optimum tissue sampling with the lowest possible risk. The ACS believes that only equipment that has been evaluated in peer-reviewed literature and demonstrated to be safe and effective for percutaneous breast biopsy should be accredited. Therefore, some equipment which may be commercially available but has not met this criterion may not be accredited by the ACS for use in breast biopsies. The accreditation should provide confirmation that the lesion undergoing biopsy corresponds to the lesion that was worrisome mammographically. It should provide educational feed back to the facility about ways to diminish the number of x-ray exposures required for appropriate positioning and thereby reduce the radiation involved in the procedure, to establish whether histopathologic findings are concordant with imaging findings, and to optimize utilization of equipment.

Application for Accreditation

Each facility must complete an application questionnaire concerning the qualifications of personnel including physicians, radiologic physicists, and radiologic technologists. Information will also be collected on the facility's quality control and quality assurance program.

The supervising physician at any facility that chooses to pursue accreditation must agree to ensure that stereotactic breast biopsy procedures will not be performed by any personnel that do not meet the qualifications as described in this document and the Basic Requirements document. Non-qualifying physicians may participate in the performance of these procedures with the participation of a qualified individual. This requires that the qualified individual be in the procedure room.

Since this is a voluntary program, facilities that choose to allow individuals not qualified under the requirements of this accreditation program to perform stereotactic breast biopsy procedures are not eligible for accreditation.

If the facility fulfills the criteria related to the application form, then image quality and breast dose data are obtained. Image quality, dose, and half value-layer evaluation will be obtained using a breast phantom and thermoluminescent dosimeter (TLD). Images of the phantom as well as sets of clinical images that demonstrate the lesion and accurate needle placement, will be submitted for scoring to a review panel of radiologic physicists and radiologists. If the facility uses a screen-film system, processor quality control for a thirty (30) day period must also be submitted for evaluation.

Stereotactic biopsy accreditation is available for three types of procedures: 1) Mass accreditation is for facilities that do stereotactic breast biopsies of masses. 2) Facilities that biopsy calcifications are required to go through accreditation that includes evaluation of images from this type of lesion. 3) FNAC accreditation is for facilities that only do Fine Needle Aspiration Cytology. Facilities must submit images on hard copy film only. For those facilities that use a screen-film recording system, copies of films will be accepted.

When all stages of the evaluation are completed, a final report that includes specific assessments and recommendations will be issued. Those facilities successfully meeting all of the criteria will be awarded a three-year accreditation, a certificate and machine label for each approved stereotactic unit. The American Cancer Society, the National Alliance of Breast Cancer Organizations, National Cancer Institute, Y-ME and other patient referral organizations will be provided with an updated list of accredited facilities on a regular basis. For those facilities that do not meet the criteria, specific recommendations for improvement will be made. These recommendations should provide guidance so that a facility can meet the criteria on re-application.

On-site surveys

In order to verify that accredited facilities maintain consistent quality during the three-year accreditation period, on-site surveys may also be performed at any time during the accreditation process. The Stereotactic Breast Biopsy Accreditation Program reserves the right to conduct on-site surveys either prior to or after accreditation. These surveys provide an excellent opportunity for a positive educational exchange with experts in the field as well as providing validation of information submitted. Any facility chosen for an on-site survey will be notified in advance. A surgeon, as well as radiologist and physicist reviewers from the Stereotactic Breast Biopsy Accreditation Program will be members of the survey team along with a staff person.

Four-Step Accreditation Process

Step 1: Applicant must qualify, obtain, and send completed forms.

• The surgeon must meet physician qualifications. For information, see the section Statements/Guidelines of the American College of Surgeons.
• The applicant must obtain and complete an entry application. Call 312-202-5442 for information or e-mail cburgin@facs.org.
• The applicant must send the required forms and accreditation fee to the American College of Surgeons, Stereotactic Breast Biopsy Accreditation, 633 N St Clair St, Chicago, IL 60611. The fee is $1400 first unit / $1200 each additional unit.

Step 2: ACS will review, verify, or return the application.

• The application is reviewed for completeness (1 week).
• The surgeon's skills are verified.
• Successful applicants are referred for survey.
• The applicant is notified by letter.

OR

• The incomplete application is returned.
• The applicant receives instruction to:
• Resubmit completed form/fee in 2 weeks.
• Request committee review of qualifications.

Step 3: A survey is conducted and the facility is notified of results.

• The ACR sends a complete packet (2 weeks) with dosimeter(s) and instructions to submit QC documents/test images.
• The applicant can call 877/487-3839 for additional information.
• The survey is conducted by mail.
  • Random team visits include a surgeon, radiologist, and physicist.
• The facility receives a 3-year accreditation with report, certificate, and machine label.

OR

• The facility receives notification and recommendations for improvement (8-12 weeks).

Step 4: The facility may appeal the award or request a re-evaluation.

• The facility can appeal the accreditation decision directly to ACR and an ACR committee review will decide the final outcome.
• The facility can request a repeat evaluation of deficiency. Only components failing to meet accreditation standards need to be re-evaluated.

Revised June 30, 2008

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