Accreditation is unit-based; therefore, facilities must notify the ACR if a unit is added, replaced with a new one, or permanently withdrawn from service. In addition, because the image quality, QC, and personnel requirements are different for screen-film and FFDM, as well as FFDM and DBT, facilities using both screen-film and CR on the same mammography unit(s), or DBT units, must accredit (and test) each unit as 2 separate units.
Adding a New or Replacement Unit
For accreditation purposes, a “new” unit is any unit that is new to the facility. This includes previously owned units, previously accredited units moved from one site to another, and new units replacing previously accredited units. To apply for a new unit under your existing accreditation, add the unit to your account by going to “My Modalities.” Click on “Units/Modules,” then on “Add New Unit” under the list of units; this will add the unit to the Modality ID for that location.
The accreditation options available for a new unit depend upon the amount of time the facility has left on its current MQSA certificate.
More than 13 months: The facility may submit a new unit addendum or a new unit reinstate:
New Unit Addendum: This option applies primarily to a facility with other fully accredited units. The facility will submit complete phantom and clinical testing for the new unit(s) and pay a reduced accreditation fee. The added unit(s) will receive the same expiration date as currently approved units for this modality.
New Unit Reinstate: This option applies primarily to a facility with only 1 unit. The facility voluntarily surrenders its current MQSA certificate and submits a reinstatement application at the full fee. The facility will immediately obtain a 6-month provisional MQSA certificate that provides them with adequate time to complete the accreditation process. Once approved, the facility will receive a full 3-year accreditation from the date of approval. (If the facility has multiple accredited units, these units must be withdrawn and apply for accreditation at the same time as the new unit.)
Fewer than 13 months: the ACR will instruct the facility to begin early renewal on all units at the usual renewal fee. Once accreditation is approved, all units at the facility will have an expiration date that is 3 years from the old expiration date.
The forms and documents needed for the application will be in the ACRedit database, depending upon which cycle is started (New unit addendum, new unit reinstatement or renewal). The medical physicist's equipment evaluation forms can be downloaded from the ACR website .
A facility with a current MQSA certificate may legally begin examining patients with a new unit after submitting a complete application (with medical physicist’s passing Equipment Evaluation results) to the ACR. 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 unit. These facilities are not required to wait for a response from the ACR to begin clinical use of the new unit since they are operating with a current MQSA certificate. However, if this is the facility’s first FFDM or DBT unit, the Center for Medicare and Medicaid Services (CMS) will not reimburse for that examination until the FDA has received notification that the facility has applied for accreditation of a FFDM or DBT unit. In order to ensure CMS payment, the facility must:
Submit the online application
Upload the application materials and the Mammography Equipment Evaluation results to the ACR in the application
Do not submit your mammography claims for 14 days (as recommended by CMS) to ensure that your local payer has the most current MQSA file
When scheduling the medical physicist’s Equipment Evaluation for your new unit be sure to allow enough time for the accreditation application process described, as well as any possible corrective action. The ACR typically recommends scheduling an Equipment Evaluation at least 1 week prior to performing mammography on patients. You cannot use the unit to examine patients even during “applications” training until you submit the application and physicist equipment evaluation to the ACR .
In addition, facilities should contact their state radiation control agencies for any state-specific requirements for new units.
Under the FDA’s Final Rules for Mammography, the medical physicist is required to perform a Mammography Equipment Evaluation when a new unit or processor is installed, a unit or processor is disassembled and reassembled in the same or a new location, or major components of a mammography unit or processor equipment are changed or repaired. MQSA inspectors will verify that the appropriate testing was performed during their annual inspection. For more information, please see our article on Mammography QC.
Loaner and Demonstration Units
Accredited facilities may use a “loaner” unit to temporarily replace an accredited unit that is out of service for repairs, etc. Accredited facilities may use a “demo” unit obtained from a manufacturer for use on a temporary basis either to determine whether the unit meets their needs before deciding to make a purchase or to use while awaiting delivery of a new unit.
Mammography facilities choosing to use a loaner or demo unit must submit a letter to the ACR, signed by the lead interpreting physician or president/CEO documenting that they have a loaner/demo unit and providing the unit’s manufacturer, model and serial number. For loaner units, the letter must state the reason for the use of the loaner, and must provide the estimated date that the loaner unit will be replaced by the permanent unit.
A qualified medical physicist must perform an Equipment Evaluation (as required by MQSA) after the loaner/demo unit is installed and before it is put into service. The facility must submit the Medical Physicist’s Mammography QC Test Summary and the Medical Physicist’s Checklist - MQSA Requirements for Mammography Equipment to the ACR. Once received and reviewed, the ACR will send the facility a response letter acknowledging receipt of notification and compliance.
The facility is required to maintain compliance with all routine quality control tests and frequencies as defined under MQSA.
A loaner unit may not be used for more than 30 days without applying for ACR accreditation (this period may be extended for up to 90 days upon written verification from a repair service that there is legitimate cause for repairs to exceed 30 days). A demonstration unit may not be used for more than 90 days without applying for ACR accreditation. If the loaner/demo unit is going to be in place more than 90 days, and the facility has more than 13 months left on its MQSA certificate, the temporary unit must either undergo full testing following the instructions in the New Unit Addendum or give up its current MQSA certificate and accredit the temporary unit (and any other active units) with the New Unit Reinstatement process described above. If the facility has fewer than 13 months left on its MQSA certificate, the facility must renew its accreditation early with the temporary unit in addition to any other mammography units in use at the facility. In all cases, the temporary unit must undergo clinical and phantom image quality testing as part of this accreditation.
When a repaired unit is returned and reinstalled after using a loaner unit, a qualified medical physicist must perform an Equipment Evaluation (as required by MQSA) before the old unit is returned to service.
If the facility purchases a demonstration unit after evaluation, it must proceed with accreditation. The required accreditation process will be determined by the amount of time left on the facility’s MQSA certificate.
Please note that if a facility chooses to use a loaner/demonstration unit for a modality that they do not currently have accredited (FFDM/DBT) without starting the accreditation process, reimbursement may become an issue. The Center for Medicare and Medicaid Services (CMS) will not reimburse for a new modality (FFDM/DBT) until the FDA has received notification that a facility has applied for accreditation on that modality. In these cases, the ACR recommends that facilities start accreditation on the temporary unit so that they may be reimbursed at the higher digital rate.
Contact the ACR for assistance specific to your situation.
Withdrawing a Unit or Module
If a unit is no longer used for imaging, the facility must withdraw the unit from the accreditation system. Go to “My Modalities”, click on the “Units/Modules” link under the action column, and then click the “Withdraw” link under the action column. The facility must complete and submit the Withdraw Unit Application and submit the Withdrawn Unit Memorandum to the ACR. If your account is due for renewal, the unit may be withdrawn in the renewal application.
If a module is no longer in use the facility must withdraw the module from the accreditation system. Please note that a facility is required by FDA to maintain accreditation on the FFDM portion of their mammography unit. The FFDM module cannot be withdrawn without withdrawing the entire unit. If your facility will no longer use the DBT module, go to "My Modalities" click on the "units/Modules" link under the action column, then click the "Withdraw" link under the action column. the facility must complete and submit the Withdraw unit Application and submit the Withdrawn Unit Memorandum to the ACR.
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