In response to the recent natural disaster that has affected MQSA-certified facilities in the Gulf Coast Region, the Food and Drug Administration (FDA) developed a plan to assist facility personnel affected by Hurricane Katrina.
FDA will assist personnel affected by the hurricane in documenting compliance with the MQSA personnel qualifications. Upon request, FDA will provide a letter to affected personnel that can be used to document compliance with all MQSA initial qualifications. In addition, FDA will not require these personnel to document continuing education and experience requirements during inspections conducted before September 1, 2007. Personnel are encouraged to use this grace period to obtain documentation of continuing education and experience as well as any expiring initial requirements (e.g., State license) and be prepared to document these requirements during inspections conducted on or after September 1, 2007.
The letter will be based on personnel qualifications as documented at the time of the person’s most recent MQSA inspection and will list the person’s starting date and whether he/she qualified under the interim or final regulations. If the person documented 8 hours of initial training in Full Field Digital Mammography at a previous inspection, that will also be stated. The letter may be used at mammography facilities for employment purposes as proof of meeting the initial MQSA qualifications and continuing requirements, as outlined above. MQSA inspectors are to accept the letter as adequate documentation of initial qualifications. MQSA inspectors will not enforce compliance with continuing education and experience requirements for the affected personnel during inspections conducted before September 1, 2007.
While the letter serves to document MQSA qualifications, the information described above is not designed to limit a State from exercising its authority with a facility that it has found to be in violation of State law or to prohibit State inspectors from exercising any authority delegated to them by State laws, regulations, or policies. For example, while the letter deals with MQSA requirements, the State may require personnel to be licensed or certified in that specific State. Failure to have such documentation may result in violation of a State regulation.
The letter may be used as a permanent record of meeting the initial qualifications except for those documents which expire (e.g. State license). Those individuals that have never been through inspection at a facility will be dealt with on a case-by-case basis. They should call the Facility Hotline for assistance.
The affected individual must make the request for this letter in writing. The written request may be faxed to 1-410-290-6351 or sent by email to MQSAhotline@SSSI.net, Attention: Hurricane Katrina. Affected personnel may also call the Facility Hotline at 1-800-838-7715 for more information. Upon receipt of requests, FDA will respond within two (2) business days. Information needed on the request includes:
- Individual’s name
- Personnel Category (RT, IP or MP)
- Individual’s Phone #s
- Individual’s Address
- Individual’s Fax # (if applicable)
- Email Address
- Name and address of affected facility
- MQSA Facility ID# (if known)
- Facility Phone #
- How and where individual would like to receive documentation (email, fax or U.S. mail)