Radiation-Emitting Products

Are there any additional issues we should be aware of when providing mammography results to referring healthcare providers or patients?

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FDA has occasionally identified problems with the methods that some facilities use to provide mammography results to referring healthcare providers and patients. While the vast majority of facilities have adequate written standard operating procedures (SOPs) regarding the provision of mammography reports and lay summaries to referring healthcare providers and patients, some facilities do not track or monitor the issuance of the reports and/or lay summaries. Consequently, some referring healthcare providers and patients are not receiving their examination results or are not receiving them in a timely manner.
MQSA allows facilities to develop or use a procedure and tracking system that works best for them. Facilities should monitor their systems to ensure that their policies and procedures are being followed. FDA supports the use of computer tracking and paper or patient log systems to assist in tracking timely issuance of medical reports and lay summaries. Some radiology computer reporting systems can track individual reports and generate summary reports indicating when a mammography report or lay summary has been issued or is overdue. By routinely checking these summary reports, facilities can ensure that all mammography results have been issued in a timely manner. FDA encourages facilities (1) to check with their computer support vendors to determine whether their software can generate these types of reports, and (2) to routinely assess their system(s) to ensure that these systems consistently document issuing mammography lay summaries and reports to all patients and their referring healthcare providers within the required timeframe.
Facilities that fax or email medical reports and/or lay summaries should have policies and procedures in place to ensure that, if any faxes or emails are reported as “delivery failure,” the reports and lay summaries are re-sent in a timely manner.


Page Last Updated: 06/20/2014
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