Revision History


Validation Cycles are testing cycles which do not grant accreditation. These cycles are to validate that your facility is consistently operating within MQSA and ACR requirements and guidelines. Some validation cycles are random, and some cycles are performed for a particular concern regarding image quality.


Validation (Random) Image Checks (VIC/RIC)

Under MQSA, the ACR is required to conduct “random” clinical image reviews of a sample of facilities to monitor and assess their compliance with standards established by the body for accreditation. Facilities are required to participate if requested by the ACR. The ACR uses this review as an opportunity to provide facilities with mid-cycle educational feedback on image quality. The review is conducted by means of a validation image check of randomly selected facilities each year.


The ACR recognizes that the clinical images selected for this evaluation may be drawn from a relatively small sample of images in relation to the total number of mammograms performed at the facility. Furthermore, variations in image quality may be attributed to the natural anatomical differences present in the female population. Reviewers will take this into consideration when evaluating validation images. The ACR will provide a report when the review is complete.


If your facility is chosen for a Validation Image Check, the accreditation database will send an email to the account login. Click on "My Testing Packages," find the Validation Image Check, and click "Modify". You should contact the ACR Mammography Accreditation Program Information Line at (800) 227‑6440 for further instructions if your facility cannot comply with the terms of the Validation Image Check.


If a facility receives a deficiency report for a Validation Image Check, they must submit a corrective action plan to the ACR within 14 calendar days of the report. All documentation showing completion of the corrective action plan is due to the ACR within 60 days of the deficiency report. Following this, the facility must participate in a repeat Validation Image Check (or undergo early accreditation renewal if there is less than 13 months left on the facility’s accreditation) to demonstrate that they have adequately corrected the identified problems.  


Random On-Site Surveys (ROSS)

The FDA requires the ACR to conduct on-site surveys of a random sample of accredited facilities. Any facility chosen for an on-site survey will be notified in advance. The survey team will include ACR radiologist and medical physicist reviewers and an ACR staff technologist. During this survey, the ACR team will review the facility’s:

  • Quality assurance program

  • Mammography policies and procedures

  • Personnel qualifications

  • Clinical images and mammography reports


In addition, the site visit team will work with the facility’s staff to acquire and evaluate a phantom image. These site visits offer facility staff an excellent opportunity for personal interaction with experts in the field as well as providing validation of facility accreditation information.


Additional Mammography Reviews (AMR), Targeted Image Checks (TIC) and Targeted On-Site Surveys (TOSS)

If the FDA, Certifying Agency or the ACR believes that mammography quality at your facility “has been compromised and may present a serious risk to human health” (see FDA Policy Guidance Help System: “Additional Mammography Review and Patient Notification”), your facility may be required to submit clinical images and other relevant information for review. This review can vary between 2 and 30 cases. These cycles

  • Can be used as a follow up to previous image quality concerns

  • May include submission of a phantom image

  • May be reviewed as part of an on-site survey at the facility or through submitting images to ACR

  • May be required if facilities receive repeat EQUIP violations [see Enhancing Quality Using the Inspection Program (EQUIP)]


The ACR will notify you of the need for an AMR at your facility and will request images from specified dates.


After thorough review, a final report will be issued to the lead interpreting physician and also forwarded to the FDA or other Certifying body.

 



Revision History for this Article

Date

Section

Description of Revision(s)

12-12-19

All

Article created; FAQs incorporated; No criteria changes



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