- Additional Mammography Review and Patient Notification
- Evaluations of Inspection Observations that May Lead to an AMR and Patient and Physician Notification Physician Notification
The Food and Drug Administration (FDA) developed this Additional Mammography Review (AMR) guidance to inform facilities of possible actions when FDA believes that mammography quality at a facility has been compromised and may present a serious risk to human health. Information that could cause FDA to suspect that quality may have been compromised could include:
- A MQSA inspection with a level 1 inspection observation for phantom image testing
- A MQSA inspection with a level 1 inspection observation forinterpreting physician qualifications
- Extensive failures to comply with the equipment quality assurance requirements under 21 CFR 900.12(e)
- Evidence or information obtained from a facility’s accreditation body or from physician, patient, or technologist complaints regarding a quality problem at the facility
- Evidence that records demonstrating compliance with the quality standards under 21 CFR 900.12 have been falsified
- Performance of mammography without an MQSA certificate
A level 1 inspection observation 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, as well as the other examples listed above, 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 is performed to assess whether any of the problems noted above affected clinical image quality. A level 1observation 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 interpretations. If FDA determines that the problems rise to the level of a significant risk to human health, FDA may require the facility to notify patients and their referring physicians of the deficiencies, the potential harm resulting, appropriate remedial measures, and such other relevant information as FDA may require.
This authority is stated as follows (21 CFR 900.12(j)):
(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 the regulations and this policy. They are an AMR conducted by the facility’s accreditation body which we refer to as an AMRABand an AMR conducted by another entity which we refer to as an AMROE. Under AMRAB, the facility’s accreditation body is asked to conduct the AMR. Under AMROE, FDA works with the facility to identify a qualified reviewing physician(s) to perform the AMR. The physician(s) is subject to FDA approval.
Facilities subject to an AMR may also be subject to other regulatory and enforcement actions by FDA, for example a Directed Plan of Correction (DPC) to correct violations in a timely manner or a patient and physician notification. See 42 U.S.C. 263b(h) and (i) for other actions, including civil money penalties, or suspension or revocation of certification, that FDA may impose on facilities.
Note: The interpreting physician(s) conducting the image review for AMRAB or AMROE should not have a relationship with the facility
, or otherwise have a conflict of interest. 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 of the estimated cost and other relevant information, such as whether payment must be received prior to the start of the AMRAB.
Because the AB already has procedures and personnel in place for performing AMRs, this type of AMR will generally be the preferred method. However, if FDA considers it appropriate, it may propose an AMROE, or accept a facility’s proposal for an AMROE. In an AMROE, FDA would specify how the AMR would be conducted (including timeframes), how the patient exams would be selected, and the qualifications of the reviewing physician(s) (including the physician’s specialized training in evaluating clinical image quality). FDA would work with the facility to identify an acceptable reviewing physician(s). If an AMROE acceptable to FDA cannot be arranged, the facility must undergo AMRAB.
- All level 1 observations for phantom image testing are confirmed through a second review by a 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 Standards (DMQS) provides the second review.
- After confirmation of the level 1 observation that a physician was not board certified and did not have initial training in mammography and/or never had a valid license to practice medicine or the license to practice medicine was revoked, FDA determines whether an AMR is appropriate based on the seriousness of the violations.
- After confirmation of the level 1 inspection observation(s), FDA may notify the facility in writing that it must undergo AMR.
- The AMR letter advises the facility that it must undergo an AMR, that it may be responsible for the cost of the AMR, and that further details (including how the AMR will be conducted) will follow in a letter from FDA and/or the AB. The type (AMRAB or AMROE) and scope of the AMR are 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 was so inconsistent with the quality standards as to represent a significant risk to human health, FDA may require the facility to undertake a patient and referring physician notification.
- If the results of the AMR do not indicate a significant risk to human health, FDA evaluates the results of the AMR to determine if additional follow-up or monitoring is necessary.
- FDA also assesses whether to take other regulatory and enforcement actions, as needed.
- Approved Alternative Standards/Requirements
Evaluations of Inspection Observations that May Lead to an AMR and Patient and Physician Notification Physician Notification:
This authority is stated as follows (21 CFR 900.12(j)):
All the approved alternative standards can be found on the following webpage: