AMR General Guidance

Background

The Food and Drug Administration (FDA) developed this Additional Mammography Review (AMR) guidance to inform facilities of possible FDA actions when MQSA inspections show a Level 1 finding for phantom image testing or interpreting physician qualifications. A Level 1 finding represents a deviation from MQSA standards that may seriously compromise the quality of mammography services offered by the facility. FDA has determined that these specific Level 1 findings are indicators that serious quality problems may be present at the facility and require further evaluation. An assessment of the quality of mammograms produced by the facility should indicate whether the equipment problems that resulted in the Level 1 phantom image finding have affected clinical image quality. A Level 1 finding for the phantom image test exists when the score is less than 3 fibers, less than 2 speck groups, and/or less than 2 masses. Regarding interpreting physician qualifications, an assessment of mammograms and mammography reports may indicate whether failure to meet specific personnel standards has affected the quality of mammographic findings.

In addition to these two specific inspection findings, other problems could result in FDA requiring AMR for a facility. For example, evidence or information may be obtained from a facility’s accreditation body or patient or physician complaints that could convince FDA to require an AMR. In the case where serious quality problems are suspected at a facility, FDA may require that the facility undertake an investigation of the impact of these findings on the clinical images produced by the facility or of the interpretations rendered by the interpreting physician. If FDA determines that the problems rise to the level of a significant risk to human health, FDA may require the facility to undertake patient/physician notification.

This authority is stated as follows (21 C.F.R. 900.12(j)):

Additional mammography review and patient notification.

(1)  If FDA believes that mammography quality at a facility has been compromised and may present a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by FDA, for review by the accreditation body or other entity designated by FDA. This additional mammography review will help the agency to determine whether the facility is in compliance with this section and, if not, whether there is a need to notify affected patients, their physicians, or the public that the reliability, clarity, and accuracy of interpretation of mammograms has been compromised.

(2)  If FDA determines that the quality of mammography performed by a facility, whether or not certified under Sec. 900.11, was so inconsistent with the quality standards established in this section as to present a significant risk to individual or public health, FDA may require such facility to notify patients who received mammograms at such facility, and their referring physicians, of the deficiencies presenting such risk, the potential harm resulting, appropriate remedial measures, and such other relevant information as FDA may require. Such notification will occur within a timeframe and in a manner specified by FDA.

There are two specific types of AMR identified in this policy. These are AMR Conducted by the Facility (AMRF) and AMR Conducted by the Accreditation Body (AMRAB). Under AMRF, FDA works with the facility to identify a qualified interpreting physician(s) to perform the AMR. The physician(s) is subject to FDA approval. Under AMRAB, the facility’s accreditation body is asked to conduct the AMR.

This policy does not prevent FDA from taking legal actions against facilities, in addition to AMR, where the use of an MQSA sanction may be necessary to compel a facility to comply with FDA regulatory requirements. As an example, FDA may issue a Directed Plan of Correction (DPC) to a facility to address serious problems at the facility. The DPC may require the facility to take specific corrective actions. 42 U.S.C. 263b(h)(1)(A). FDA may require the facility to notify patients and/or their referring physicians of facility problems, in the event the AMR indicates mammography quality problems are present that would justify such a notification.

Note: The interpreting physician(s) conducting the image review for AMRF or AMRAB should not have a relationship with the facility, conduct the review when it would otherwise be a conflict of interest for them to do so, or when they have a bias in favor of or against the facility. Before the facility's accreditation body (AB) conducts AMRAB, the AB may require reimbursement of its expenses for the AMRAB. In this case, the AB should notify the facility accordingly, including an estimate of the cost to conduct the AMRAB. The AB may also require payment prior to the start of the AMRAB.

If a facility has a Level 1 phantom image finding or a Level 1 interpreting physician finding, FDA may require the facility to undergo an AMR. Because the AB already has procedures and personnel in place for performing AMRs, this generally will be the preferred method. However, if FDA considers it appropriate, it may propose an AMRF. The facility would then provide FDA with specific details as to how the AMR would be conducted, how the patient exams would be selected and the qualifications of the proposed interpreting physician (including the physician’s specialized training in evaluating clinical image quality). If FDA does not approve the facility’s proposal, the facility must undergo AMRAB.

Evaluations of Inspection Findings Leading to an AMR and Patient/Physician Notification:

• All phantom image test results at Level 1 will be confirmed through a second review by the MQSA auditor or an FDA MQSA inspector (or by the State, if the State has a thorough phantom image quality assurance (QA) program in place). For those cases where there are no second reviewers available, the Division of Mammography Quality and Radiation Programs (DMQRP) will provide the second review.
• After confirmation that a physician was not board certified and did not have initial training in mammography and/or never had a valid license or the license to practice medicine was revoked, FDA will evaluate the findings to determine whether an AMR is appropriate.
• After confirmation of the Level 1 finding(s), a Warning or Untitled Letter may be sent to the facility.
• The Warning or Untitled Letter should advise the facility that it is required to undergo an AMR, that it will be responsible for the cost of the AMR, and that further details (including whether an AMRF or AMRAB will be required) will follow in a letter from FDA and/or the AB. The type (AMRAB or AMRF) and scope of the AMR will be determined by FDA (usually after consultation with the facility’s AB).
• If the results of the AMR indicate that the quality of mammographic images or interpretations at the facility represent a significant risk to human health, FDA may require the facility to undertake notification of patients and/or referring physicians.
• If the results of the AMR do not indicate a significant risk to human health, FDA will evaluate the results of the AMR to determine if additional follow-up or monitoring is necessary.