|
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  |
|
 | ||
  |
| Information
for mammography facility personnel, inspectors, and consumers about the implementation of the Mammography Quality Standards Act of 1992 (MQSA) |
 |
The Division of Mammography Quality and Radiation Programs has been made aware that sometimes there are issues with the methods some facilities use to track that mammography results are provided to referring healthcare providers and patients. Some MQSA facilities may not be consistently tracking or monitoring that medical reports and/or lay summaries are being provided on time or at all. As a result, some referring healthcare providers and patients are not receiving their exam results or are not receiving them in a timely manner. In most instances, facilities have established written procedures in place to issue the reports, however, in practice, the tracking of reports is sometimes not adequate to ensure timely issuance of the mammography results.
MQSA allows facilities to develop or use a procedure and tracking system that works best for them. Facilities need to monitor their systems to ensure that their policy and procedures are actually and correctly 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. By routinely checking these summary reports, facilities can ensure that all mammography results have been issued in a timely manner. Facilities are encouraged to check with their computer support vendors to see if their software can generate such summary reports. FDA encourages all facilities to reassess their current systems, whether they are computerized or paper logs to ensure that they communicate mammography results to all patients and their referring healthcare providers.
Another sometimes overlooked problem deals with facilities that fax or email medical reports and/or lay summaries. Policies and procedures to deal with faxes and emails that are reported as “failed” are important to ensure that reports and lay summaries are resent in a timely manner.
Facilities may obtain additional information about medical records and mammography reports from the MQSA Policy Guidance Help System located on this website (Search on keywords: Medical Records, Mammography Reports, Mammographic Assessments, Written Report, Recordkeeping, and Communication of Mammography Results.)
1. Printer and/or Monitors without QC Manuals
Under the Mammography Quality Standards Act (MQSA) final regulation 900.12(e)(6), facilities using a mammographic modality other than screen-film must follow a quality control program that is “substantially the same as the quality assurance program recommended by the image receptor manufacturer…”. While all full field digital mammography (FFDM) manufacturers have quality control (QC) manuals, in some cases, the QC manual instructs the facility to test monitors and printers according to the component’s QC manual. In these cases, it is the responsibility of each facility to ensure that it obtains and follows the component’s QC manual for its monitors and printers.
2. Facilities Using the Same Printer or Monitor with FFDM Units from Different Manufacturers
For facilities that are using FFDM units from different manufacturers, each with its own QC requirements for printers and monitors, there may be uncertainty regarding the QC tests to perform on these components. The following three examples should help facilities decide.
a. Each FFDM manufacturer QC manual requires that the same or equivalent test be done, but at different time frequencies. In this case facilities need to perform the test at the more stringent frequency.
b. Each FFDM manufacturer QC manual requires that different but equivalent tests be done. In this case facilities may perform only one of the tests at the more stringent frequency. The medical physicist should provide a written statement for the facility’s quality control records, indicating that in his or her opinion, the two tests are equivalent.
c. Each FFDM manufacturer QC manual requires that different tests (not equivalent) be done. In this case facilities need to perform each test at the frequency required in the respective FFDM manufacturer QC manual.
We recently learned that some medical physicists are not including appropriate testing of the laser printer in their survey /MEE report to the facility. There seems to be confusion between the required MEE testing of a laser printer: (1) before it is first put into clinical use; (2) following reassembly; or (3) after major repairs vs. the routine Quality Control (QC) testing of the laser printer after it is placed into clinical use. In some cases, the medical physicists did not test the laser printer at all. In other cases, they did inappropriate testing and, in a few cases, they did appropriate testing but did not include documentation of the tests in the facility survey / MEE report. Therefore, we want to clarify the MQSA requirements regarding this issue.
The final regulations require that all test procedures be conducted as specified in the QC manual of the FFDM system manufacturer. Some of these QC manuals specify both periodic QC (daily, weekly, or annual) and MEE testing for the laser printer. Other manuals do not address the subject and refer the user to the laser printer manufacturer’s QC manual. For easy reference, the following table summarizes laser printer test procedures in current QC manuals:
| FFDM System | QC Manual | Weekly/Daily | Annual | MEE | QC Procedures - Comments |
|---|---|---|---|---|---|
| GE- All systems | All | Yes* | No | No | *Per printer mfr. QC manual |
| Fischer | Rev.10-10/07 | Daily check | No | No | Follow printer mfr. QC manual |
| Selenia | Rev. 7–8/07, **Sec. 2.1 | Yes | No | Yes** | Follow the Selenia QC manual |
| Siemens | Rev. 5–4/07 | Before clinical use | No | Yes | Follow printer mfr. QC manual |
| Fuji | 3rd Edit.–4/07 | Yes | Yes | Yes | Follow applicable printer QC manual |
As the above table shows, some of the FFDM QC manuals do not specifically address the laser printer MEE testing requirements when first installed, reassembled, or after having undergone a major repair. Hence, the facility or medical physicist has to obtain this information from the laser printer manufacturer. In some cases, the QC manuals only address the interface between the FFDM unit and the laser printer. They do not address the basic requirement that the laser printer, before it is used clinically for mammography, has to be operating as designed by the laser printer manufacturer. Since the MEE requires that both these areas be checked, the medical physicist may have to consult both the FFDM manufacturer’s QC manual and the laser printer QC or operator’s manual to determine which tests are required to assure that the laser printer is functioning properly.
Some medical physicists incorrectly assume that simply scoring a laser printed phantom image satisfies all the requirements of the laser printer MEE. However, in most cases, this practice would not be acceptable. To avoid unnecessary follow-ups by MQSA inspectors, we urge all medical physicists to review the FFDM manufacturer’s QC manual and, where necessary, the laser printer QC or operator’s manual to determine the appropriate testing. They then need to clearly document the testing of the laser printer in their reports.
On January 1, 2008, FDA will modify the current inspection software (FISS Version 6.03) to allow citations for failures in the following areas:
Thus, effective January 1, 2008, if the inspector answers “no” to the above question, the software program will issue a level 2 observation, which will be applicable to both S-F and FFDM systems.
Updated September 8, 2008
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH