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Information
for mammography facility personnel, inspectors, and consumers
about the implementation of the Mammography Quality Standards Act of 1992
(MQSA) |
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What
Actions Can FDA Take to Ensure Quality Mammography? |
by Sharon M. Davis
Consumer Safety Officer, Inspection and Compliance Branch
Division of Mammography Quality and Radiation Programs
Office of Communications, Education, and Radiation Programs
December 13, 2004
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Background
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.
FDA Sanctions
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.
- Suspension
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.
- Revocation
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.
- Injunction
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.
Closing comments
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 at http://www.fda.gov/cdrh/mammography/.
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Updated December 16, 2004
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