Authorization for Stereotactic Breast Biopsy

Discussion:
The Rules require that all machines used for stereotactic breast biopsy (SBB) and the facility in which the machine is used meet the criteria of the American College of Radiology's (ACR) Stereotactic Breast Biopsy Accreditation Program. A mammography machine that uses a specially designed add-on device for SBB must be specifically authorized to perform both mammography and SBB.

All mammography authorizations are valid for three years or until substantial changes are made to the information in the authorization application (i.e. a change in equipment). 

Upright mammography machines with SBB add-on devices must be authorized for both screening/diagnostic mammography and SBB under the current standards. 

Question 1: What is the process to become authorized for SBB?

Question 2: Are we required to be accredited in SBB by the ACR?

Question 3: What is involved if we decide not to become accredited in SBB by the ACR?

Question 4: Our mammography machine has an add-on device which allows us to perform SBB procedures. Do we need to obtain an authorization to perform SBB with our add-on device?

Question 5: Stereotactic breast biopsy add-on devices are not radiation machines, i.e., they do not have an x-ray tube or produce radiation. How can the Department require them to be authorized for mammography?

Question 1: What is the process to become authorized for SBB?

Request a Mammography Machine Authorization Application by calling 517-284-7820, by fax at 517-763-0131, or by e-mail at rssinfo@michigan.gov. The application form will ask for facility information, personnel information, machine information, imaging system information, designation of the lead interpreting physician, and an application fee if appropriate. The application fee will be waived if the machine is accredited in SBB by the ACR, in the process of becoming accredited in SBB by the ACR, or if evidence of an application for SBB accreditation by the ACR is submitted within 45 days of the authorization application. The authorization application fee is listed in the current fee table. 

Question 2: Are we required to be accredited in SBB by the ACR?

SBB facilities are required to be either be accredited in SBB by the ACR or complete the Department's evaluation of compliance with ACR's SBB accreditation criteria, as described in R 333.5610.

While the rules allow facilities to complete the Department evaluation in lieu of becoming accredited in SBB by the ACR, the Department strongly encourages each facility that performs SBB to seek and achieve accreditation in SBB by the ACR. When authorization is issued to a facility that uses the Department evaluation path, the certificate will indicate that the machine is not accredited.

Question 3: What is involved if we decide not to become accredited in SBB by the ACR?

If the SBB facility decides to go through the Department evaluation of compliance, your authorization application must be accompanied by payment of the evaluation fee. The application will not be considered complete without the fee. After we receive a complete application and decide that the information on the application complies with the rules, a temporary authorization will be issued. We will then request the following information which must be submitted to the Department within 45 days of our request:

• Confirmation that the facility has a Department-approved phantom. The phantom may be a full-size mammography phantom or a mini digital stereotactic phantom.
• Processor or laser film printer quality control data and corrective actions, if any, taken as a result of that data for a 30-day period beginning after the date the application was sent to the Department.
• An image of a Department-approved phantom taken during the same 30-day period for which the processor QC data is required.
• Determination of the half-value layer, radiation exposure at skin entrance, and mean glandular dose that are made with the use of a Department-provided TLD dosimeter. The dosimeter must be exposed on the phantom at the same time the phantom image is made.
• A set of clinical images produced on or after the date the application was sent to the Department. Currently the Department has not contracted with any mammography experts to review clinical images. Once we determine how many facilities will request the department evaluation, we will seek a contractor to perform these evaluations. Once that arrangement is finalized we will then request the submittal of clinical images by those facilities.

Question 4: Our mammography machine has an add-on device which allows us to perform SBB procedures. Do we need to obtain an authorization to perform SBB with our add-on device?

Yes. As stated in R 333.6505(a), a facility must have separate authorizations for both the mammography machine and the add-on SBB device.

Question 5: Stereotactic breast biopsy add-on devices are not radiation machines, i.e., they do not have an x-ray tube or produce radiation. How can the Department require them to be authorized for mammography?

The Department "registers" radiation machines - SBB add-on devices are not registered since they are not radiation machines. However, in Michigan, machines that perform mammography, including interventional mammography, must be "authorized" to perform mammography. An upright mammography machine is authorized to do standard screening mammography and if they also use an add-on device to perform SBB, under the revised rules they also need to be authorized to perform a SBB procedure. If a facility does not perform standard mammography with an upright machine but only uses it with an add-on device to perform SBB, they would only need to be authorized for SBB.

10/3/2016