Options Following a Failure or Deficiency: Mammography (Revised 12-12-19)
Modified on: Fri, 13 Dec, 2019 at 2:33 PM
If a facility does not pass accreditation:
The ACR’s final report will provide specific recommendations for improvement.
If this is a unit’s first attempt, the facility should take corrective action on its own.
If this is a unit’s second attempt, the ACR must notify the FDA of its failure. In these cases, the facility must submit documentation of corrective action in order to reinstate.
Facilities may appeal any denial of accreditation.
After a failed outcome, the facility has the opportunity to submit an option form to proceed with accreditation through a repeat, reinstatement, appeal, or withdrawal of the unit in question from the accreditation process entirely. These options are described in detail below .
To access your option form, go to “My Final Reports” and click “Select Option” under the option status column.
For film submissions, the option form is available 48 hours after images are returned to your facility. For uploaded submissions, the option form is available 48 hours after the final report is issued.
Option forms are due 15 days after the date they are sent. Please review your final report and options with your lead interpreting physician before completing your option form. Your final report link must be accessed by the lead interpreting physician or facility administrator before the option form is available.
Facility options after unsuccessful attempts at accreditation are outlined here:
Accreditation Not Granted
1st Deficiency: Facility may continue performing mammography with the unit as long as they have a valid certificate
REPEAT ‘not acceptable’ area(s) (only if more than 60 days on MQSA certificate)
REINSTATE by retesting all areas (if 60 days or fewer on MQSA certificate)
APPEAL decision on original images
2nd Deficiency (= 1st failure): The ACR strongly recommends that the facility cease performing mammography with the unit
REINSTATE by retesting all areas (with corrective action)
APPEAL decision on original images
3rd Deficiency (= 2nd failure): The ACR strongly recommends that the facility cease performing mammography with the unit
REINSTATE after participating in scheduled on-site survey
APPEAL decision on original images (may not operate until appeal is complete)
If a facility has adequate time remaining on its MQSA certificate, it will be given the opportunity to repeat the test that was deficient. If there is not enough time to repeat the tests before the MQSA certificate expires, the facility will have to submit a corrective action plan and reinstate by completing and submitting the application, all testing materials and a reinstatement fee.
If a mammography unit is eligible to repeat, it will automatically be placed in a repeat cycle and submitted by the ACR when the deficiency report is issued. This will assist the facility in getting through the accreditation process in a timely matter. If your facility wants to appeal or withdraw from accreditation, you should contact the ACR for instructions. Repeat testing materials and payment are due within 20 days of the final report date. Go to ‘My Testing Packages’ and click 'modify' to access your repeat testing package .
If you are REPEATING a test for a deficiency, only submit images from the deficient test (i.e., all clinical images, both fatty and dense, and/or the phantom). Repeat exams are new exams not previously submitted for ACR review and should be collected after the date on the deficiency report. This allows reviewers to assess the overall improvement in image quality since the previous deficiency and to determine whether the facility took all reviewer comments into consideration.
If the site repeats (or reinstates) and receives a second deficiency, it fails accreditation. The ACR will notify the FDA (or the state certifying body) of this failure. In order to resume the accreditation process, the facility must reinstate.
Reinstatement requires the facility to fully document its history and address all deficiencies noted in previous reports. An appropriate corrective action plan should be designed by the facility, approved by the ACR before implementation, then fully implemented, and documented to show proof of correction. The ACR may also direct the facility to make some specific corrective action. Once all corrective actions are completed and supporting documentation has been forwarded to the ACR, the facility may receive a 6-month provisional reinstatement certificate from the FDA (or state certifying body) and may go through the accreditation process again.
Corrective Action Plans
Submission of a Corrective Action Plan alone is not enough to obtain a provisional FDA certificate. Although the corrective action plan may discuss the problems the facility had in obtaining accreditation and what they plan to do to correct these deficiencies, these plans must be fully carried out and specifically documented to show proof of correction. That is the primary reason for reinstatement. If facilities were to be reinstated based on what they plan to do and without fully implementing the plan, their past problems might remain uncorrected. This could hinder their next testing cycle for accreditation and ultimately prevent them from obtaining accreditation.
In the event that a facility does not pass accreditation due to positioning:
The ACR typically requires 8 hours of hands-on training to be completed for corrective action. The positioning training documentation must be signed by the MQSA-qualified individual providing the training. If the training is performed at another site, the documentation must include that site's MAP#, address all the deficiencies noted in the previous reports, and include a statement that resultant images were critiqued and acceptable.
The ACR requires that all technologists at the facility receive training – not just the technologist who performed the submitted exam. The ACR specifies that you send your best quality work during accreditation; therefore, if your clinical images do not pass, the ACR must assume that all mammography performed at your facility, by all technologists, is of equal or lower quality. Proper patient positioning is crucial to obtaining consistently high-quality mammograms so that your patients receive the best medical care possible.
If the facility fails again, it will have to participate in a Scheduled On-Site Survey. The Scheduled On-Site Survey is conducted so that an ACR review team (consisting of a radiologist, a medical physicist and an ACR staff mammography technologist) can review the facility’s progress and provide on-site training in areas where help may be needed. This process takes time, and the facility is responsible for payment of a base site-visit fee in addition to all travel expenses incurred by the ACR team.
If you disagree with the ‘not acceptable’ decision in your accreditation final report based on the images that you submitted, you have the option to appeal. This is true of any initial, renewal or reinstatement cycle. Appeals are due within 30 days of the unsuccessful report date. Reasons for appeal typically involve disagreement with image quality.
To appeal, the exact same original images or data (no additions) must be resubmitted with a letter describing the reason for appeal. Both fatty and dense cases must be submitted for clinical appeals in order to allow the reviewer to assess the overall clinical performance of the facility.
Images will be forwarded to an arbitrator (a reviewer who did not participate in the initial review) with a copy of the previous reviews and the appeal letter written by the facility. No other images or data will be sent to the reviewer for consideration in the evaluation. The arbitrator’s determination will be final.
If a unit is denied accreditation after an appeal of a failure (second deficiency), the facility has the right to appeal directly to the FDA. However, such an appeal will stop the ACR application process until the FDA renders a decision. Further, the facility making the appeal may not perform mammography during the FDA appeal process. Facilities are not permitted to appeal to the FDA after a first deficiency appeal is denied by the ACR.
Appeal submissions must be completed the same way as the original (if you submitted on film, you must appeal on film; if you submitted electronically, you must appeal electronically).
Film Appeal Submissions
Appeal submissions include:
A letter signed by the lead interpreting physician (if clinical) or physicist (if phantom) detailing the reason for appeal. If appealing both clinical and phantom results, please include two letters – one clinical and one phantom
The original images resulting in the “not acceptable” decision
Mail your appeal materials to:
The American College of Radiology
ATTN: Mammography Accreditation Program
1891 Preston White Drive
Reston, VA 20191
Electronic Appeal Submissions
Complete the option form and select:
“Other options” (select box)
“Appeal” (select box)
“Lead Interpreting Physician Attestation” (check box)
Appeal Letter (upload electronic file)
Withdrawal of Failed Unit
A failed unit may be withdrawn if the site no longer performs mammography on that unit. To withdraw a unit:
1. Complete option form in ACRedit
Go to “My Final Reports” and click “Select Option”
Select “other options”
Check all modules or patient types you wish to withdraw from the accreditation process
Check the attestation box at the bottom of the screen.
2. Submit the withdraw form signed by the listed supervising (lead interpreting) physician or facility officer/owner and fax to 703-648-9176.
If you are withdrawing your only unit from the accreditation process entirely, the system will prompt you to complete a Facility Closure Memorandum.
Revision History for this Article
Description of Revision(s)
Article created; FAQs incorporated; No criteria changes
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