What Actions Can FDA Take to Ensure Quality Mammography?
The Mammography Quality Standards Act (MQSA) was signed into law on October 27, 1992, to establish national quality standards for mammography. The law requires that facilities comply with minimum standards for quality mammography (21 CFR Part 900.12). If a facility fails to do so, the Food and Drug Administration (FDA) has several mechanisms to encourage the facility to comply.
FDA may become aware that a facility has problems in several ways:
- MQSA annual inspections
- Information supplied by the accreditation body
- A complaint from the public
When FDA becomes aware that a facility may not comply with the standards, it investigates to determine if further action is warranted. If FDA's follow-up finds serious violations, a Warning Letter may be sent to the facility (A Warning Letter notifies a facility of the possible consequences if the problems are not corrected in a timely manner). A facility may also be subject to an Additional Mammography Review (AMR) if there is reason to believe that the mammography quality at a facility has been compromised. Under an AMR, the facility must provide clinical images and other relevant information (which may include mammography reports), for review by the facility's accreditation body or by an FDA-approved interpreting physician not associated with the facility. The AMR will help FDA determine if the facility must notify affected patients, their physicians, or the public that the reliability, clarity, and accuracy of interpretation of mammograms has been compromised.
There are several regulatory actions that the FDA may take to help bring a facility back into compliance with the MQSA regulations and protect the public. The regulatory actions are:
- Directed Plan(s) of Correction (DPC)
Under section 354(h)(1)(A) of the MQSA (42 U.S.C. 263b(h)(1)(A)), FDA may impose a DPC which affords a facility an opportunity to correct violations in a timely manner. Under a DPC, FDA can require the facility to take corrective actions including having facility personnel obtain additional training, having the facility submit its quality control testing to be reviewed on a periodic basis, or having FDA perform more frequent inspections.
- Patient and Physician Notification (PPN)
FDA has the authority to require a PPN when the quality of mammography at a facility may present a significant risk to individual or public health. This authority can be found under 21 CFR Part 900.12(j)(2), and 42 U.S.C. 263b(h)(2). FDA would usually consider a PPN after finding, through an AMR, serious problems with mammographic quality at a facility. The notification to the patients and their referring physicians would explain the problems found at the facility and actions the patients should take to reduce their risk.
- Civil Money Penalties (CMP)
A CMP is a fine levied against a facility and/or individuals by the FDA for serious violations of the MQSA. Its purpose is to remove any monetary incentive for a facility to violate the MQSA. A facility may be subject to a CMP up to $10,000 for failure to obtain a certificate (42 U.S.C. 263b(h)(3)(A)) and up to $10,000 for each mammography examination conducted without a certificate (42 U.S.C. 263b(h)(3)(D)). Other violations may be assessed at $10,000 per violation (42 U.S.C. 263b(h)(3)(B)). However, prior to assessing a CMP, FDA would notify the facility by letter of its intent to assess a penalty and provide instructions for requesting a hearing.
Under section 354(i) of the MQSA (42 U.S.C. 263b(i)), FDA can suspend a facility's certificate temporarily to prevent the facility from performing mammography until it has corrected the serious problems that were found. FDA would normally hold a hearing prior to suspending the certificate. However, if FDA finds a serious risk to human health or that the violations were intentional, FDA could suspend a facility's certificate prior to a hearing.
Under section 354(i) of the MQSA (42 U.S.C. 263b(i)), a revocation of a certificate is an action taken by the FDA that prohibits a facility from operating, with the expectation that it will not be operating in the near future. FDA may decide to revoke a facility's certificate when suspension of a certificate is not enough of a penalty due to the seriousness of the violations. If FDA revokes a facility's certificate, the owner or operator of the facility may not operate that facility or any other facility for two years after the date of revocation. FDA would generally revoke a certificate of a facility that has repeatedly failed to comply with the regulations. The facility must be given an opportunity for a hearing before FDA may revoke its certificate.
Under section 354(j) of the MQSA (42 U.S.C. 263b(j)), an injunction under MQSA is a court order that allows FDA to stop a facility from providing mammography when there is a serious risk to human health or the facility is performing mammography without a certificate. Violation of the order can result in criminal contempt sanctions. FDA would normally use this mechanism when other FDA actions, including other sanctions, have failed to bring a facility into compliance or to stop a facility from performing mammography without a certificate. Under certain circumstances, where continued operation of a facility constitutes a serious hazard to the public health, FDA may choose this as a course of action.
- Criminal Prosecution
In cases where there has been fraud or other criminal activities, FDA's Office of Criminal Investigation (OCI) may investigate. Should the investigation reveal evidence of criminal activity, FDA would work with the Department of Justice for possible prosecution of those involved.
Since the beginning of the MQSA program, there have been 29 regulatory actions imposed against mammography facilities. There have been 16 PPNs, 6 DPCs, 3 CMPs, and 4 Suspensions. We have never imposed a Revocation or Injunction against a facility. Although an AMR is not a regulatory action, its outcome occasionally results in a regulatory action. Since the beginning of the program, we have had 61 AMRs performed.
Listed below are examples of each of the above sanctions and the facility actions that would prompt it:
Directed Plan(s) of Correction - A facility is having continuing problems with its quality assurance program or equipment.
Patient and Physician Notification - An accreditation body or another FDA-approved outside party conducts an AMR at a facility and after reviewing all the information, FDA determines that the quality of mammography at the facility presents a serious risk to individual and public health.
Civil Money Penalties - A facility knowingly performs mammography without a valid MQSA certificate.
Suspension - A facility has been required to notify patients and physicians of a serious risk to human health. The facility refuses to notify affected individuals.
Criminal Prosecutions - Personnel falsified their initial qualifications and/or quality control testing, putting patients at risk.
A facility that meets the minimum qualifications to perform mammography services must be knowledgeable of the regulations and prepared to take the appropriate steps to successfully achieve compliance with the MQSA regulations.
For additional information about the MQSA and its requirements, you may visit the FDA website.