Radiation-Emitting Products

What criteria will FDA use to determine that facilities meet the MQSA requirements for providing lay summaries and mammography reports to their patients and health care providers?

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One way to meet the requirements for providing lay summaries and mammography reports is for facilities to have written procedures for all of the following:

  •  providing (sending or giving) the written lay summary to patients within 30 days of the examination.
  • providing the mammography report to the health care provider (or the patient, if self referred) within 30 days of the examination.
  • communicating the results of positive (suspicious or highly suggestive of malignancy) examinations to patients and health care providers as soon as possible (FDA recommendswithin 5 and 3 business days of the date of interpretation, respectively). This communication may be verbal or written. If verbal, it must be followed by a written lay summary and mammography report provided within 30 days of the examination.
AND either
 
1.         Demonstrate to the inspector that:
  • the facility is notifying patients and health care providers of positive examinations as soon as possible (FDA recommendswithin 5 and 3 business days of the date of interpretation, respectively). In the case of verbal communication, this may be done by documenting such communication in the mammography report or in logs. In the case of written communication, see next two bulleted items.
  • the facility is providing written mammography reports.   This may be done by having copies of the mammography report available within 30 days of the examination (positive mammography reports should be available within 3 business days of the date of interpretation).
  • the facility is providing written lay summaries. This may be done by having copies of the lay summary available within 30 days of the examination (positive lay summaries should be available within 5 business days of the date of interpretation). If the facility does not keep copies of the patients' lay summaries, it may document such communication in the mammography report, or in logs, or by stating in the facility's Quality Assurance (QA) manual that the lay summary is provided within the appropriate time frames.
OR
2.         For facilities with computerized reporting systems, provide the inspector with a list or print-out documenting that all lay summaries and mammography reports have been sent out within the 30 day timeframe and that all positive results have been communicated, either verbally or by means of the written report, to patients and health care providers as soon as possible (FDA recommends within 5 and 3 business days of the date of interpretation, respectively).
 

 

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Page Last Updated: 08/12/2014
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