   |
Information
for mammography facility personnel, inspectors, and consumers
about the implementation of the Mammography Quality Standards Act of 1992
(MQSA) |
|
 |
Natural
Disasters - Effects on Mammography Facilities
Please refer to FDA's existing procedures below regarding mammography facilities and natural disasters:
In the event of a natural disaster, there are certain actions mammography facilities
can take to help ensure that they continue to provide high quality mammography
services. Depending on the amount of damage sustained by a facility, its equipment,
critical records, and even patient records and/or mammogram films may have been
damaged or destroyed. In the aftermath of these events, your mammography facility
may find it a challenge to comply with MQSA regulations.
To assist facilities in complying with MQSA regulations, any facility damaged
by a natural disaster should:
- Inform its accreditation body (AB) and State Radiological
Health Department of the situation as soon as possible and notify them of
any change in the facility’s mammography unit(s) or location.
- Inform the Facility Hotline (phone 1-800-838-7715, fax
410-290-6351, or email MQSAhotline@hcmsllc.com)
of the situation as soon as possible and notify them of any change in the
facility’s mammography unit(s) or location.
- Request instructions from its AB immediately if, because
of the disaster, facility personnel determine that scheduled reaccreditation
cannot be completed before a current accreditation expires.
- Record the date range for which facility records (e.g.,
quality control records, patient logs) and patient records and/or mammogram
films have been lost or damaged. The documentation should identify the date(s)
involved and the reason(s) these records were lost or damaged. The facility
should keep this documentation for possible review by the AB, State Radiological
Health Department personnel, the State Certifying Agency, if applicable, and
the MQSA inspector. Additionally, the State Radiological Health Department
may be able to advise the facility regarding specific State requirements dealing
with damaged or lost patient records and/or mammogram films.
- Inform your patients: If patient records and/or mammogram
films were damaged or lost, the facility may want to notify the affected patients.
- Retain a medical physicist to conduct an equipment evaluation
of any equipment that undergoes a major repair, is disassembled and reassembled,
or is replaced. The equipment must successfully pass the evaluation before
the facility can use the equipment to image patients. The facility may
also want to perform other tests, such as routine facility quality control,
to ensure that its equipment is performing properly.
A facility may contact the FDA, the State Radiological Health Department, the
State Certifying Agency, if applicable, or its AB for further information if
a natural disaster has affected its operations. Together, FDA, MQSA inspectors,
State Programs, and Accreditation Bodies will work with facilities struck by
natural disasters to help them resume practicing high quality mammography.
Back to General Information
Page
Updated July 9, 2008
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
