Adding a New Module
If your unit is upgraded to include a new Mammographic Modality as defined by FDA, you will apply for accreditation on the new module prior to the performance of mammography. A facility with a current MQSA certificate may legally begin examining patients with a new module after submitting a complete application (with medical physicist’s passing Equipment Evaluation results) to the ACR. The equipment evaluation must have been performed within 6-months of applying for the new module application. Once the application is approved and accepted as complete, the ACR will notify the FDA that an accreditation application has been accepted for the new module.
Units adding DBT to their existing accredited FFDM unit would apply mid-cycle, adding the DBT module onto the existing unit instead of adding a new unit. You’ll be required to submit
Two Clinical images, a fatty case, and a dense case, 2D acquired or 2D synthesized images, as currently allowed.
Phantom image: Best slice tomosynthesis image, either in DICOM or non-DICOM format
All routine QC and the medical physicist report
At least one interpreting physician, one technologist and one medical physicist must be qualified in the new modality.
Adding a New Unit
To apply for accreditation on a new unit, mammography users will need to add a new unit. If your unit also performs Digital Breast Tomosynthesis (DBT); you must add both modules. If the new unit is at a different physical location, you will need to add a new mammography facility.
Mammography facilities must complete a relocation application within 10 calendar days after the relocation. When all accredited units are moved to a new address, you may be required to submit additional testing and fees.
In order to maintain accreditation in the event of a move, you must notify the ACR prior to moving your facility to a new address. Use ACRedit Plus to update the facility information. Click on “my modalities,” then “modality details.” Click the “change” button next to the facility location address. Answer the questions to begin your relocation application.
If your unit is disassembled and reassembled as part of this move, the FDA requires your medical physicist to conduct an Equipment Evaluation to ensure that the unit works properly. These completed materials will let the ACR know whether your units still meet all MQSA requirements after the move and will allow both the ACR and the FDA to ensure that essential, time-dependent accreditation and certification notices reach your new location.
If the move consists of rolling the unit into a different room (with no disassembly and reassembly), an Equipment Evaluation may not be necessary. You should consult with your medical physicist. In either case, the FDA requires you to perform a phantom image quality test before use on patients per their guidance, Mobile Units Equipment Quality Control.
A unit’s accreditation does not transfer to a new facility, whether that new facility is an existing, certified site affiliated with your facility or an additional site you are opening at a different address. In either case, the unit is considered “new” to its new site and must undergo an Equipment Evaluation by your medical physicist, ensuring compliance with all MQSA requirements. Add a new unit to an existing certified site through ACRedit Plus by going to “my modalities” and clicking on “units/modules,” then on “add new unit.”
In the event that you are opening a new facility, you must apply for mammography accreditation of the new facility. You must access ACRedit Plus, and start an application at least 2 weeks before you expect to start performing mammography. If your facility has an existing online accreditation account, you may log in and create your new mammography facility. If you have never logged into ACRedit Plus for other modalities, click “Create an account” to create a new account. This will give you time to download the additional application materials that must be completed prior to submission. Upon acceptance of your complete application, the ACR will notify your certifying body (the FDA or the state) that you have begun the process of accreditation. You may not perform mammography until you receive a 6-month provisional MQSA certificate or an interim notice from your certifying body. An MQSA certificate cannot be used to cover 2 separate physical locations, even temporarily.
Facilities with separate physical locations and addresses must each have their own MAP ID numbers. Mammography equipment physically located at different addresses must be accredited and certified as though they belong to separate facilities even though ownership and/or staffing may be the same.
If you need assistance, please submit an Accreditation Support request. Instructions can be found in Questions About Accreditation.
Changing the Facility Name
The facility name is the legal business name of a facility. To change the facility name, go to “my modalities,” click “modality details,” and click the “change” button next to “facility name”. If you have a new supervising physician or facility owner, you may update these names in this application. The system will ask whether you would like a new ACR certificate in the name change application. There is a fee for new certificates.
If you are closing a facility, you must close the online accreditation account. Each modality closing at a facility must complete the closure application and submit a signed closure form. Your facility will no longer be listed as accredited on the ACR accredited facility search and you must take down all signage for the closed facility. To close: go to “my modalities”, click “modality details”, and click “close modality”.
If a facility ceases mammography and closes its doors, both the ACR certificate and the MQSA certificate must be removed from display. Despite closure, the FDA continues to hold the facility responsible for assuring that there is a mechanism to release the records, including patient images, to the appropriate entity when requested. Before a facility permanently stops performing mammography, it should do all of the following:
Inform the ACR that it will no longer be performing mammography.
Notify its state radiation control program.
Arrange transfer of each patient’s medical record (original mammography images and reports) to the mammography facility where the patient will be receiving future care, the patient’s referring physician or health care provider, or the patient.
The facility should make reasonable attempts to inform former patients as to how they can obtain their mammography records (facilities should check with state or local agencies to determine whether their requirements are more stringent). Radiology practices and other medical facilities that still see patients but have permanently stopped performing mammography may choose to keep patients’ medical records rather than transfer them to another facility (unless the patient requests such a transfer).
If transfer of records to the facility where a patient will be receiving future care is not viable, facilities must assure that there is a mechanism to release records to the appropriate entity when requested and that former patients are made aware of that mechanism. For example, a facility could store the medical records in a hospital, if appropriate, or make arrangements to warehouse the records. If no one else is willing to accept the records, the facility remains responsible for them.
If a facility is changing ownership, this must be completed as soon as possible following the effective date of the transaction.
To complete an ownership change application, click on “my modalities”, then “modality details” and then click the “change” button next to the current ownership name. This will open a change in ownership application to be completed and submitted to the ACR along with the New Owner Agreement form.
The only time a mammography facility is able or required to change their personnel (other than the owner, supervising or lead interpreting physician, or the contact person) is when the facility is completing an application (renewal, new unit reinstatement, or reinstatement). However, you should be aware that the FDA or state MQSA inspector will verify the qualifications of any new personnel during your next inspection.
To complete a change in lead interpreting physician, click on “my modalities”, then “modality details.” Then click the “change” button next to the lead interpreting physician’s name. Complete and submit the application and send or fax the required documentation listed within the application.
To update personnel during a renewal, new unit reinstatement or reinstatement application, go to “my applications”, click “modify”, and update the personnel sections. The personnel list is divided by role: physician, physicist, technologist, and other personnel (other personnel includes administrative staff, assistants, consultants, or billing coordinators who may call the ACR to discuss your account; ACR accreditation information is privileged and confidential; individuals MUST be on the personnel list to discuss a specific accreditation account when calling the ACR.)
In our accreditation information to the facility, we state that all facility accreditation information is “privileged and confidential under the Code of Virginia 8.01-581.17” regulations. The ACR is legally bound to respect this and must not discuss facility accreditation issues with outside individuals. However, in unique cases, a facility may wish an outside entity (such as an attorney or consultant) to communicate with the ACR on behalf of the facility. In these cases, the ACR will ask the facility’s lead interpreting physician to send a letter formally requesting this. However, it is critical in all cases that the facility’s staff receives direct communication from the ACR on all accreditation issues since they have the ultimate responsibility for meeting ACR requirements.
Revision History for this Article
Description of Revision(s)
Article created; FAQs incorporated; No criteria changes
|11-09-2022||Add New Module||updated for ACRedit Plus|