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.
Random Image Checks RIC
The FDA requires the ACR to conduct “random” clinical image reviews of a sample of facilities under MQSA. This is 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 an 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 Random Image Check, the accreditation database will send an email to the account login, Lead Interpreting Physician (LIP) and Technologist Contact. Click on "My Testing Packages," find the Random 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 Random Image Check.
If a facility receives a deficiency report for a Random Image Check, they must participate in a Repeat Random Image Check with Corrective Action Plan. While there is no fee for the Random Image Check, there is a fee associated with the Repeat Random Image Check with Corrective Action Plan. The facility must submit a corrective action plan to the ACR within 14 calendar days of the report. ACR staff will review the submitted plan. After the plan is approved and the fee is received by ACR staff, the facility may proceed with implementing the plan. All documentation showing completion of the corrective action plan is due to the ACR within 60 days of the deficiency Random Image Check report. Following this, the facility must participate in a repeat Random 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 and quality control programs
Mammography policies and procedures
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 a 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. A fee will be charged to the facility for 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 the facility of the need for an AMR 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
Description of Revision(s)
Article created; FAQs incorporated; No criteria changes
|Clarification of name of Random Image Check, clarification for fees.
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