|                                                                                                                                                                                                                                                                                                                                                            |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Volume 7, Issue 2                                                                                                                                                                                                                                                                                                                                          |   | Spring 2000 |
| In This Issue...Adding the FFDM System to Your MQSA CertificateMammography Today Update!From the DirectorNew Mammography Program WebsiteEnsuring High-Quality Mammography:  Spotlight on InspectorsInspection Fee Payment ReminderRecognizing Inspectors' ServiceFDA Addresses Consumer IssuesQ&AAccreditation, Certification, and Commercial Products | Q&A

The following questions and answers come from FDA's Policy Guidance Help System, part of the Mammography Program website to help facilities comply with MQSA regulations. People with questions about MQSA guidance should refer to the Help System for approved FDA answers. FDA welcomes any questions about MQSA or its Mammography Program.

Q. What are appropriate charges for the transfer of mammography records and can the facility charge the cost of making copies of the films to the patient?

A. Appropriate charges for transfer of mammography records could include: - administrative costs incurred in logging in the request, 
- retrieving the appropriate films and reports, 
- having the patient sign a release (if not already done), 
- packaging and mailing charges for the materials, and 
- photocopying costs incurred in making copies of the report.

Facilities may, but are not required to, make copies of the mammography films.  If these copies are requested by the patient or are mandated by State regulations, then the cost of making the copies can be charged to the patient.  If the facility wishes to keep copies for its own benefit, the cost cannot be charged to the patient.

If requested by the patient, facilities must be able to produce documentation (an itemized bill, for example) that the charges do not exceed the costs associated with this service.

Q. If there is more than one lesion identified on the mammographic examination, do I need to have a final assessment category for each lesion or just one assessment for the entire mammographic examination?

A. One overall assessment category for the entire mammography examination is required, and it should be based on the most suspicious lesion or finding.  However, individual assessments for other lesions, along with recommendations for their management, may also be included in the report.

Q. If a facility issues an "addendum" or "comparison" report after the initial mammography report has already gone out, are these reports required to have an overall final assessment category?  Must the "addendum" or "comparison" report also be provided to the referring health care provider and the patient, even if there is no change in the final assessment category or recommended course of action?

A. Yes to both questions.  The report issued after additional testing that is covered under MQSA (e.g., coned, repeat, magnification views) or following comparison with old films should reflect the final assessment category for the case following these additional tests or comparison studies.  A report of this nature must be communicated to the referring health care provider or the self-referred patient, just as any other report would be.  In addition, a lay summary of the "addendum" or "comparison" report sent to the health care provider (or self-referred patient) must be provided to all patients, even if there is no change in the final assessment category or recommended course of action.  For the specific case where there is no significant change in the report, a simple statement that the comparison has been performed and that there is no overall change would satisfy the requirement.  If the "addendum" merely stated that the referring health care provider had been notified of the results of the patient's examination, the addendum lay summary could be a simple statement informing the patient of that fact.
***Facility Hotline***Call the facility telephone hotline (1-800-838-7715) or fax (410-290-6351) for more information about FDA certification or inspections.*Mammography Matters*is a quarterly publication of the Division of Mammography Quality and Radiation Programs (DMQRP), Center for Devices and Radiological Health (CDRH), Food and Drug Administration. Its purpose is to help mammography facilities comply with the requirements of the Mammography Quality Standards Act of 1992. Comments should be addressed to: *Mammography Matters* | FDA/CDRH (HFZ-240) | 1350 Piccard Drive | Rockville, MD 20850Fax 301-594-3306 |