After a severe weather incident or natural disaster, a mammography facility may have sustained damage to its facility structure, equipment, critical records, and even patient records. Mammography films may have been damaged or destroyed. In the unfortunate event that a mammography facility experiences the effects of severe weather or a natural disaster, there are actions a facility can take to help ensure that they continue to provide high quality mammography services. Below you will find advice to assist your facility in the event of severe weather or a natural disaster.
- Your facility's Accreditation Body (AB) and your State Radiological Health Department of the situation as soon as possible. Notify these agencies of any change to your facility's mammography equipment, location, and/or your facility's ability to provide mammography services.
- The MQSA Facility Hotline of the situation as soon as possible as to your facility's mammography equipment status, its location, and your facility's ability to provide mammography services. Contact information for FDA MQSA:
- Phone: 800-838-7715
- Fax: 410-290-6351
- Email: MQSAhotline@hcmsllc.com
- Your patients if their patient records and/or mammogram images were lost, damaged, or compromised.
Follow the Three R's:
- Request: Instructions from your AB if your facility is in the process of reaccreditation and cannot complete the process before the current accreditation expires due to severe weather or a natural disaster.
- Record: The date range from which your facility records (i.e., quality control reports, patient logs, patient records, and/or mammogram films) may have been lost or damaged. Include the date(s) and a reason(s) these records were lost or damaged and retain this documentation. Check with your State Radiological Health Department regarding specific State requirements related to damaged or lost patient records and/or mammogram images.
- Refer: To MQSA requirements about evaluation of any equipment that undergoes a major repair, is disassembled and reassembled, or is replaced. The facility may also want to conduct other tests, such as routine facility quality control assessment, to ensure that equipment is performing properly.
A facility may contact the FDA, the State Radiological Health Department, the State Certifying Agency, or if applicable, it's AB for further information if severe weather or a natural disaster has affected its operations. Together, the FDA, MQSA inspectors, State Programs, and Accreditation Bodies will work with and support facilities affected by natural disasters to assist them in resuming the practice of providing high quality mammography.