1.   Conducting the daily processor QC tests when the sensitometer is not available

This alternative standard was approved on October 18, 1999 and was made retroactive to April 28, 1999. It has no time limit. The alternative to sensitometric-densitometric testing of processor performance can be used for a period of up to two weeks when the facility's sensitometer is unavailable. This alternative is based on evaluating a phantom image through measurements described in 21 CFR 900.12(e)(1) and (2).

The final regulation and its alternative standard are stated below:

21 CFR 900.12(e)(1) and (2) states that:

This alternative test must be conducted "each day clinical films are processed, but before processing of clinical films." All results must be recorded and charted. If processor performance fails to meet any part of the alternative test, the problem must be corrected before processing is resumed.

2.  Continuous display of the override status for machines with decompression devices

This alternative standard was approved on June 22, 1999 and was made retroactive to April 28, 1999. It has no time limit.

The final regulation and its alternative standard are stated below:

21 CFR 900.12(e)(5)(xi) states that:

3.  Conducting the weekly phantom image test at facilities with intermittent mammography operation

This alternative standard was approved on May 24, 1999 and was made retroactive to April 28, 1999. It has no time limit. It applies to facilities that do not conduct mammography every week. Rather, they may conduct mammography during some, but not all, weeks in a given month.

The final regulation and its alternative standard are stated below:

21 CFR 900.12(e)(2) states that:

The alternative standard requires that if the number of weeks per month in which clinical mammography is performed increases or decreases, the frequency of the performance of the phantom image quality test must automatically undergo a corresponding increase or decrease.

4.  Post exposure indication of the machine pre-selected focal spot and or target material

This alternative standard was approved on April 19, 1999 and became effective on April 28, 1999 for Senographe™ DMR GE machines. It has no time limit.

The final regulation and its alternative standard are stated below:

21 CFR 900.12(b)(7) states that:

Under the approved alternative, an indication of the pre-exposure focal spot and target material would no longer be required when the pre-exposure target material and focal spot are set by a system algorithm based on exposure and the user has no control over that selection. In operating modes where the user has control of the pre-selected focal spot and/or target material, indication of the pre-selected values would still be required. In all cases, indication of the focal spot and/or target material actually used during the exposure would be required.

5. Verification Testing After Certain Modifications of the AEC of Senographe™ 700T, 800T, DMR Mammography Systems

This alternative standard was approved and became effective on September 24, 2001. It has no time limit. Under this alternative, the verification after the specified AEC modifications may be performed under the conditions of Medical Physicist Oversight.

The final regulation and its alternative standard are stated below:

21 CFR 900.12(e)(10) states that:

Mammography equipment evaluations. Additional evaluations of mammography units or image processors shall be conducted whenever a unit or processor is installed, a unit or processor is dissembled and reassembled at the same or a new location, or major components of a mammography unit or processor equipment are changed or repaired. These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in paragraphs (b) and (e) of this section. All problems shall be corrected before the new or changed equipment is put into service for examinations or film processing. The mammography equipment evaluation shall be performed by a medical physicist or by an individual under the direct supervision of a medical physicist.
 

The alternative applies to the specific situations described below, in which manufacturer’s software modifications have been made to specific units. In such cases, an onsite mammography equipment evaluation performed by the medical physicist is not required. Instead, all that is required is oversight by the medical physicist.

The approved alternative standard states that for:
 

Verification testing to demonstrate that the affected equipment meets the applicable standards must be carried out after these actions are completed. However, verification testing may be performed under Medical Physicist Oversight. Medical Physicist Oversight means that the medical physicist is consulted as to whether an on-site visit is required or if other personnel can verify that the standards are met, with direction by telephone or printed material from the medical physicist as needed.

6. Conducting the Mammography Equipment Evaluation After a Software Upgrade Under Medical Physicist Oversight

This amended alternative standard was originally approved and became effective on May 31, 2002. It was last amended on October 26, 2007. It has no time limit. It defines the conditions under which the mammography equipment evaluations performed after some computer software upgrades may be performed either by a medical physicist on site or under the conditions of Medical Physicist Oversight. If these conditions are not met, the mammography equipment evaluation after the upgrade must be performed by a medical physicist on site.

The original standard is contained within 21 CFR 900.12(e)(10):
 

The approved alternative and the conditions for its use are:

Software changes or upgrades are considered by FDA to be major repairs, thus the facility must have a mammography equipment evaluation performed after installation of such a change or upgrade. The mammography equipment evaluation must be performed and all failures to meet the applicable standards must be corrected before the affected equipment is used for patient examinations. The tests to be included in the mammography equipment evaluation must be specified by the manufacturer and must meet the following conditions:

1. The specified tests must be adequate for determining whether all of the standards of 21 CFR 900.12(b) and (e) that are applicable to the upgrade are met.
2. All the tests included in the mammography equipment evaluation must be either tests that are performed by the quality control technologist as part of the quality assurance program required by the manufacturer, or tests specific to the upgrade which are of no greater complexity than those performed by the quality control technologist as part of the quality assurance program required by the manufacturer.
3. None of the necessary tests after the software upgrade are required to be performed by the medical physicist.

Additional conditions for using this alternative requirement in association with a software upgrade are that

4. The manufacturer must notify FDA of its intention to install the upgrade. The notification must include a brief description of the upgrade, the model(s) of the units that will be upgraded, a list of the post installation tests that the facility needs to perform, and a copy of the information to be provided to each facility describing the upgrade and the facility's post installation responsibilities.
5. The manufacturer must confirm in the notification to FDA that the tests to be performed for the mammography equipment evaluation are either tests that are performed by the quality control technologist as part of the quality assurance program required by the manufacturer or tests specific to the upgrade which are of no greater complexity than those performed by the quality control technologist as part of that quality assurance program.
6. The manufacturer must confirm that none of the required tests must be performed by a medical physicist.
7. The manufacturer must receive an acknowledgement from FDA of receipt of the upgrade notification before beginning the upgrade installation.
8. By the completion of each individual upgrade, the manufacturer must inform the facility in writing of its post installation responsibilities under the alternative requirement, which are that the facility must:
   • conduct a mammography equipment evaluation after installation of the upgrade, either during a medical physicist onsite visit or under Medical Physicist Oversight,
   • include in its mammography equipment evaluation the tests specified by the manufacturer,
   • perform the mammography equipment evaluation and correct all test failures before the affected equipment is used for patient examinations, and
   • keep records of the test results and follow-up actions in accordance with 21 CFR 900.12(d)(2).

If all the above (1-8) conditions are met, then the mammography equipment evaluation may be conducted either during an onsite visit by a medical physicist or under Medical Physicist Oversight. If any of the necessary tests after the software upgrade are required to be performed by the medical physicist, the mammography equipment evaluation must be performed in its entirety by the medical physicist on site.

FDA’s acknowledgement as stated in item 7 above does not constitute approval of the type of testing of the software upgrade in question. FDA will contact the FFDM manufacturer if any issues arise concerning the upgrade in question. As a result, FDA may disallow testing the software upgrade under Medical Physicist Oversight if it determines that one or more of the above conditions were not met.

Before the October 26, 2007 amendment which generalized the conditions for approval, General Electric (GE) applied to the FDA and obtained approval to conduct the mammography equipment evaluation (MEE) under Medical Physicist Oversight for the software upgrades and to the GE units shown in the Table below:

Notification of Software Upgrades Under Amended Alternative Standard #6

The new amendments provide a revised FDA approval process for new software upgrades that eliminates the need for FDA to specifically approve each new software upgrade for which mammography equipment evaluation (MEE) testing may be conducted by the radiologic technologist under medical physicist oversight. Instead, FFDM manufacturers are required to notify FDA of their new software upgrades for which the MEE may be conducted under medical physicist oversight. FDA will then simply acknowledge receiving this notification, and the manufacturer may then proceed with disseminating the upgrade.

1. GE Healthcare - Effective 10/29/07

Several software upgrades identified as:

• SA2_06.1.3_P01
• SA2_07.1, which was also distributed as Field Modification Instruction (FMI) 12092, “PV3 for SenoAdvantage 2.0 and 2.1.”
• SA21_04.1_P01
• SA21_05.1, which was also distributed as FMI 12092.
• SMFitAct 3.3.0 CD

The first four of these upgrades are intended to address image presentation issues on various versions of the SenoAdvantage workstation. The fifth is an upgrade of the software used to calibrate the displays. The issues addressed by these upgrades are described in more detail in the MEE instructions to be provided to the facility.

2. Hologic - Effective 11/21/07

Software upgrade v. 3.3 as described in “Selenia Release Notes 3.3.1.1” - The release notes include the description of the upgrade, the model, and all tests that are required to evaluate the equipment after the software change (upgrade). The Release Notes are provided to mammography facilities to inform them of which tests are to be performed for the MEE after installation, and as information regarding the Selenia software change. They include revisions back to the “Selenia 3.1.2” version and they are not meant to replace the Selenia operator’s manual. Furthermore, this software upgrade allows the configuration of the Selenia FFDM system with a tungsten (W) x-ray tube and rhodium (Rh) and silver (Ag) filtration.

3. GE Healthcare - Effective 3/14/2008

A software upgrade identified as:

• SA_04.2 that will be distributed with Field Modification Instruction (FMI) 12026A: Upgrade to Seno Advantage 1.2 (SA_04.2.1)

This software upgrade applies to the Seno Advantage 1.0, 1.1, and 1.2 Workstations that are intended for final interpretation of clinical mammograms. The issues addressed by this upgrade are described in more detail in the MEE instructions that will be provided to the facility.

4. Fuji Systems - Effective 4/2/2008

A retroactive software upgrade identified as:

• “Software Upgrade for FCRm V.4” is described in a document entitled Description of Overall Version 4 Software Changes.

This software upgrade does not require any testing by the facility prior to implementation and therefore does not require MEE testing under medical physicist oversight as called for under the amended Alternative Standard # 6.

Note: This upgrade was reviewed and approved by FDA's Office of Device Evaluation (ODE) in May 2007 as part of a pre-market approval (PMA) device modification submission.

5. Fuji Systems - Effective 4/25/08

A retroactive software upgrade identified as:

"Fuji IIPm (CR-IR348) Version 5.0(B) Software Changes." This may also be referred to as a software upgrade V5 for FCRm. This upgrade applies to the FCR Image Console (lIP), which is a dual modality workstation used for both FCRm digital mammography and general radiographic (CR) studies. It includes new functions, enhancements, and corrections in both areas. The following items of the upgrade are intended for "performance correction" and are the only ones that apply to mammography in the United States:

1. Software version HF0040 (Base:V5.0(B)) for FCR CR Console
   • Improved performance of mammography image positioning.
2. Software version HF0100 (Base:V5.0(B)) for FCR CR Console
   • The process has been added to retry JPEG process when the system fails to store an image due to JPEG lossless compression error after receiving it from the reader unit. This HotFix allows the study to continue by using a remaining ST image when JPEG compression error occurs.
   • An additional log is output when the recovery process is performed.

The Fuji representative, Customer Solutions Engineer (CSE), has/will perform a reboot of your PC from the start menu and verify that the most current software version number is indicated on the initialization screen.

This upgrade does not require any testing by the facility prior to implementation; therefore, it does not require mammography equipment evaluation (MEE) testing under medical physicist oversight as called for under amended Alternative Standard #6.

6. General Electric Seno Advantage Diagnostic Workstations – Effective 6/20/08

These upgrades will be distributed as Field Modification Instruction (FMI) 12092, “PV3 for Seno Advantage 2.0 and 2.1.” The software upgrades address image presentation issues on various versions of the Seno Advantage workstation. The issues addressed by these upgrades are described in detail in the Mammography Equipment Evaluation (MEE) instructions to be provided to the facility. They are identified by General Electric (GE) Healthcare as SA2_08.1 and SA21_05.1

The software upgrades are intended to improve the operation of image processing algorithms for some exceptional cases and there are no routine quality control (QC) tests intended to directly evaluate the system performance under such cases. A checklist will be provided by the installer informing the operator which upgrade was performed and what MEE tests need to be done. GE Healthcare believes that all of the specified tests can be performed by the QC Technologist. None of the tests are required to be done by a medical physicist. The facility’s post-installation responsibilities are included in the information to be provided to each facility.

The software upgrade identified as SA21_05.1 affects the content of the QC manual for the Seno Advantage workstation. This upgrade facilitates the operation of the workstation with either Siemens monitors or Barco monitors, and the QC manual has been revised to accommodate the differences in the details of the QC software between these two monitor types. No tests have been added or deleted. No action limits have been changed.

A copy of the new revision of the QC manual will be included with upgrade SA21_05.1. While it will be “backward compatible” and could be used by facilities that do not have Barco displays installed, there is no need for facilities with Siemens monitors to obtain a copy of the later revision.

7. General Electric Senographe 2000 D FFDM Systems – Effective 7/14/08

This upgrade is identified as Field Modification Instruction (FMI) 12063A, “Senographe 2000 D AWS v17.5 Upgrade.” This upgrade will:

• fix an Acquisition Workstation (AWS) software issue that affects the printing of images from the AWS. The printing issue relates to MQSA Quality Mammography Standards 21 CFR 900.4(c)(2)(viii)(C) and 900.12(c)(5)(iii), which specify that, on mammography images, the view name and laterality shall be displayed near the axilla. As part of the software upgrade, a new label is being provided to clarify the labeling of images viewed on the AWS.
   
• provide supplementary information regarding monitor cleaning.

It is anticipated that when this upgrade is performed, in over 90% of the systems, no detector calibration information will be lost and that there will be no change in patient dose. However, in some cases it will be necessary to upgrade the Image Detection Controller (IDC). Following this upgrade the Detector Conversion Factor and AOP calibrations, among others, must be done, and these calibrations could affect patient dose. For those cases where this occurs, the facility will be informed by the installer that the Alternative Standard may not be applied and the facility’s physicist must be contacted to perform an in-person Mammography Equipment Evaluation (MEE). By means of a checklist, the facility will be informed of the extent of the upgrades and the effect of the upgrades on the facility’s responsibilities regarding the MEE.

Following this software upgrade, the user will be instructed to check that the label regarding view and laterality labeling has been affixed to the radiation shield of the mammography system, and to print films from the AWS that demonstrate correct labeling of the images. The user is further instructed to acquire a phantom image and score it on all display devices.

8. Fuji IIPm (CR-IR348) Version 6.0(B) Software Changes – Effective 7/29/08

The FCR Image Console (IIP) is a dual modality workstation. It is used for both FCRm digital mammography and general radiographic (CR) studies. This document identifies new functions, feature enhancements and performance corrections related to software version upgrades. Some of these changes are related to mammographic applications and are identified below.

Description of Change:
Version 6.0(B) Mammography Specific Software Updates:

(1) View modifier code information setting. This function is to output View Modifier, (additional information for mammography), to DICOM server. View modifier can supply supplementary functions, such as hanging protocols, on the viewer.
(2) Ability to save an MG image to DVD at the IIP. Previously proprietary image storage format is now DICOM MG with embedded viewer.

Version 6.0(B) Software updates for General Radiography:

(1) Readability of the menu items displayed on a monochrome (gray scale) monitor will be improved by enhancing appearance of user utility.
(2) A function to embed annotation markers automatically into images will be added.
(3) A function allowing the user to confirm on the CR Console screen the current age of patients at the time of irradiation will be added.
(4) The film format for pantomography images will be expanded.
(5) The automatic stitching function will be expanded. (Addition of preview-display upon stitch operations and auto-stitching function on the QA screen).
(6) A function to delete patient information from log data will be added.
(7) A function allowing the user to select an arbitrary exam at the CR Console and create PDI will be added.
(8) A warning will be displayed should the date and time appeared upon application startup are older than those of the previous startup.

Note: There was NO CHANGE to the image processing in software version V6.0(B). The above listed changes were not due to changes in the Intended Use, and did not significantly affect safety and effectiveness of the device.

There are no applicable post-upgrade tests required to be performed by the facility. The Fuji representative, CSE (Customer Solutions Engineer), will reboot the PC from the start menu and verify that the version number indicated on the initialization screen is V6.0(B).

9. Siemens Mammomat NovationDR & Mammomat NovationS: (VA20C/VA20D to VA20E) – Effective 9/26/08

Acquisition work station software update to add new features and bug-fixes (Siemens identification numbers VA20C/VA20D to VA20E).

Acquisition work station software update to enhance image viewing features to meet country specific regulations and enhance user preference (Siemens identification numbers VA20A to VA20C).

Patch to fix “re-enter function.” Resolution of an issue with system hang-up when re-entering an exam (Siemens identification number VA20C Build 153).

10. Siemens Syngo MammoReport: VB20R/VB21 to VB22D) – Effective 9/26/08

Soft-copy review station software update to add new workflow functions and to add security hotfixes for Windows XP (Siemens identification number VB20R/VB21 to VB22D). The QC Manual for this software version is SPB7-420.621.60.01.02.

Soft-copy review station software update to provide improved performance and dedicated error correction for select systems. The update includes enhanced worklist management and support for the new IHE Mammography Image Integration profile as actor display. (Siemens identification number VB20R to VB21E). The current QC Manual for this software version is SPB7-420.621.40.01.02.

11. Software upgrades to the General Electric Seno Advantage workstation: SA2_08.1, SA21_05.1 and SA21_06.1 – Effective 12/8/08

In part, these software upgrades address image presentation issues on various versions of the Seno Advantage workstation. The issues addressed by these upgrades are described in detail in the Mammography Equipment Evaluation (MEE) instructions to be provided to the facility. These upgrades are also intended to improve the operation of image processing algorithms and primarily affect the productivity of image review. There are no routine QC tests intended to directly evaluate the system performance under such cases.

Upgrades SA21_05.1 and SA21_06.1 affect the content of the QC manual for the Seno Advantage workstation. These facilitate the operation of the workstation with either Siemens monitors or Barco monitors, and the QC manual has been revised to accommodate the differences in the details of the QC software between these two monitor types. No tests have been added or deleted. No action limits have been changed.

Upgrades SA2_08.1 and SA21_06.1 will be distributed as Field Modification Instruction (FMI) 12092, “Introduction of PV4 for Seno Advantage 2.1 and PV3+ for SA 2.0.” Upgrade SA21_05.1 will be distributed as a part ordered separately from the FMI.

7. Combined Mammography Medical Outcomes Audit for Multiple Mobile Mammography Units

FDA approved this alternative standard on November 4, 2002 and amended it on December 3, 2002. The amended alternative standard became effective on the latter date. It has no time limit. Some accreditation bodies accredit each mobile unit separately, even if two or more units are under the same ownership. This approach leads to each mobile unit being certified as a separate facility. Therefore, before the alternative requirement became effective, a separate mobile medical outcomes audit had to be performed for each unit. This alternative allows owners of multiple mobile mammography units to perform a combined mammography medical outcomes audit for all of the units if the specified conditions are met.

The original standard is 21 CFR 900.12(f)(1), which states:

21 CFR 900.12(f)(1): General requirements. Each facility shall establish a system to collect and review outcome data for all mammograms performed, including follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility. In addition, any cases of breast cancer among women imaged at the facility that subsequently become known to the facility shall prompt the facility to initiate follow-up on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy.

The approved alternative, as amended, is:

21 CFR 900.12(f)(1): General requirements. Each facility shall establish a system to collect and review outcome data for all mammograms performed, including follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility. In addition, any cases of breast cancer among women imaged at the facility that subsequently become known to the facility shall prompt the facility to initiate follow-up on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy. In situations where multiple mobile mammography facilities are under the same ownership, they may be treated collectively as a single "facility" for the purposes of meeting these requirements, if all of the following conditions are met.

(i) Each facility must consist of a single mobile mammography unit.
(ii) The same entity or group administers the operation of all of the included mobile facilities.
(iii) The same lead interpreting physician has the responsibility for assuring that all of the included mobile facilities meet the requirements of 21 CFR 900.12(d) through (f).
(iv) The same group of radiologists read all of the images from all of the included mobile facilities.
(v) All of the included mobile facilities provide services to the same patient population.

8. Separate Assessment of Findings For Each Breast

FDA approved this alternative standard on July 3, 2003. It became effective on that date. It has no time limit. It allows the interpreting physician to provide a separate assessment of findings for each breast in the medical report, without the need to also provide an overall assessment of findings. Therefore, the interpreting physician can choose between providing separate assessments under this alternative or providing an overall assessment for the examination under the original standard.

The original standard is 21 CFR 900.12(c)(1)(iv), which states:

21 CFR 900.12(c)(1): Medical records and mammography reports
…..

(iv) Overall assessment of findings, classified in one of the following categories:

The approved alternative is:

21 CFR 900.12(c)(1): Medical records and mammography reports
…

(iv) A separate assessment of findings for each breast, classified in one of the following categories:

The conditions of use of this alternative are that:

• a single medical report covering the assessment of both breasts will be sent to the referring physician (or to the patient if there is no referring physician);
• a single lay report will be sent to the patient, containing information based on the overall assessment for both breasts; and
• even though separate assessments are made for each breast, the interpretation will count as only one examination towards meeting the MQSA experience requirements and will be billed as a single examination.

9. Correction Period When Components of the Selenia Full Field Digital Mammography System Fail Quality Control Tests

This alternative requirement was approved on August 21, 2003 and became effective on that date. It was amended on October 10, 2007. It has no time limit. It allows a 30 day period for corrective actions following the failure of specified quality control tests by the Selenia Full Field Digital Mammography System. The specified tests are equivalent to quality control tests for screen-film systems for which a 30 day correction period is already allowed. The alternative standard also divides into two groups the quality control tests whose failure requires corrective action before the failing component is used again during patient examinations. This division makes it clear that when the test failure is related to the acquisition of images only, image acquisition must cease until the problem is corrected but image interpretation can continue. Similarly if the test failure is related to the interpretation of images, image acquisition can continue but image interpretation with the failed component must cease until the problem is corrected.

The original standard is 21 CFR 900.12(e)(8)(ii), which states:

21 CFR 900.12(e)(8): Use of test results

(ii) If the test results fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken:

(A) Before any further examinations are performed or any films are processed using the component of the mammography system that failed any of the tests, described in paragraphs (e)(1), (e)(2), (e)(4)(i), (e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7) of this section;

The approved alternative is:

21 CFR 900.12(e)(8): Use of test results.

(ii) If the test results for the Selenia FFDM System fall outside the action limits, the source of the problem shall be identified and corrective actions shall be taken:

(A) If any of the following quality control tests that evaluate the performance of the image acquisition components of the Selenia FFDM system produces results that fall outside the action limits as specified by the manufacturer, the source of the problem shall be identified and corrective action shall be taken before any further examinations are performed:

(1) Evaluation of System Resolution
(2) Breast Entrance Exposure and Average Glandular Dose
(3) Phantom Image Quality Evaluation (Medical Physicist)
(4) Phantom Image (Radiologic Technologist)
(5) Signal-to-Noise and Contrast-to-Noise Measurements
(6) Detector Flat-Field Calibration
(7) Compression
(8) Post-Move and Pre-Examination Tests for Mobile Selenia™ FFDM systems

(B) If any of the following quality control tests that evaluate the performance of a diagnostic device used for mammographic image interpretation (i.e. laser printer, physician's review station) produces results that fall outside the action limits as specified by the manufacturer, the source of the problem shall be identified and corrective action shall be taken before that device can be used for mammographic image interpretation. Clinical imaging can be continued and alternative approved diagnostic devices shall be used for mammographic image interpretation:

(1) Phantom Image Quality Evaluation (Medical Physicist)
(2) Phantom Image (Radiologic Technologist)
(3) Softcopy Workstation QC
(4) Laser Printer Quality Control
(5) Dark Room Cleanliness
(6) Processor Quality Control
(7) Viewboxes and Viewing Conditions
(8) Darkroom Fog

(C) If any of the following quality control tests that evaluate the performance of components other than the digital image receptor or the diagnostic devices used for mammographic image interpretation produces results that fall outside the action limits as specified by the manufacturer, the source of the problem shall be identified and corrective action shall be taken within thirty days of the test date. Clinical imaging and mammographic image interpretation can be continued during this period:

(1) Mammographic Unit Assembly Evaluation
(2) Collimation Assessment
(3) Artifact Evaluation
(4) kVp Accuracy and Reproducibility
(5) Beam Quality Assessment – HVL Measurement
(6) Automatic Exposure Control (AEC) Function Performance
(7) AEC Reproducibility
(8) Radiation Output Rate
(9) Viewbox Luminance and Room Illuminance
(10) Compression Thickness Indicator
(11) Visual Checklist
(12) Analysis of Fixer Retention in Film
(13) Repeat Analysis

10. Amendment to the Alternative Requirement for the Correction Period When Components of the Senographe™ 2000D Full Field Digital Mammography (FFDM) System Fail Quality Control Tests

The following amended alternative standard was approved on August 31, 2007 and became effective on the date of approval. It has no time limit. It supersedes Amended Alternative Requirement # 10 which was approved August 25, 2003. The current amendment adds the Sub-System MTF Measurement test to the quality control tests already listed in the 2003 amendment. The 2003 amendment replaced the specific reference to the GE Senographe™ 2000D FFDM system with a generic reference to an "FDA-approved GE" FFDM system. Like the original standard, it allows a 30 day period for corrective actions following the failure of specified quality control tests by an FDA-approved GE FFDM system. However, it divides into two groups the tests whose failure requires corrective action before the failing component is used again during patient examinations. This division makes it clear that when the test failure is related to the acquisition of images only, the review of already acquired images can continue and when the test failure is related to the image review components only, images can continue to be acquired. In approving the amendment, FDA stated that if GE introduces new FFDM systems having QC tests other than what is included in the original or amended standard, the amended alternative standard would not be applicable to such systems.

The original standard is 21 CFR 900.12(e)(8)(ii), which states:

21 CFR 900.12(e)(8): Use of test results

(ii) If the test results fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken:

(A) Before any further examinations are performed or any films are processed using the component of the mammography system that failed any of the tests, described in paragraphs (e)(1), (e)(2), (e)(4)(i), (e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7) of this section;

The approved alternative standard is an alternative is:

21 CFR 900.12(e)(8): Use of test results.

For the image acquisition system

(ii) If the test results for the image acquisition system of the FDA-approved GE full-field digital mammography (FFDM) equipment fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken:

(A) Before any further mammographic images are acquired using the image acquisition system that failed any of the following tests:

(1) Monitor cleaning for the acquisition work station (AWS)
(2) Flat Field Test
(3) CNR Test
(4) Phantom Image Quality Test for the AWS
(5) MTF Measurement
(6) AOP Mode and SNR Check
(7) Visual Check List
(8) Compression Force Test
(9) Average Glandular Dose
(10) Post-move, Pre-examination Tests for a mobile FDA-approved GE FFDM
(11) Sub-System MTF Measurement

(B) Before any further films of mammographic images are printed or processed using the component of the FDA-approved GE FFDM equipment that failed any of the following tests:

(1) Phantom Image Quality Test for the Printer
(2) Viewbox and Viewing Conditions Test
(3) Printer QC

(C) Within 30 days of the test date for the following tests:

(1) Repeat Analysis
(2) Collimation Assessment
(3) Evaluation of Focal Spot Performance
(4) Exposure and mAs Reproducibility
(5) Artifact Evaluation; Flat Field Uniformity
(6) kVp Accuracy and Reproducibility
(7) Beam Quality Assessment (Half-Value Layer Measurement)
(8) Radiation Output
(9) Mammographic Unit Assembly Evaluation

For the image display system

(ii) If the test results for the image display system of the FDA-approved GE full-field digital mammography (FFDM) equipment fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken:

(A) Before any further mammographic images are reviewed or any films are printed or processed using the component of the image display system that failed any of the following tests:

(1) Monitor cleaning for the review workstation (RWS)
(2) Viewing Conditions for the RWS (Radiologic Technologist's test)
(3) Viewing Conditions Check and Setting (Medical Physicist's test for the RWS)
(4) Phantom Image Quality Test for the RWS
(5) Phantom Image Quality Test for the Printer
(6) Viewbox and Viewing Conditions Test
(7) Monitor Calibration Check (Radiologic Technologist's test for the RWS)
(8) Image Quality—SMPTE Pattern (Medical Physicist's test for the RWS)
(9) Printer QC

(B) Within 30 days of the test date for the following tests:

(1) Monitor Calibration (Medical Physicist's test for the RWS)
(2) Analysis of the RWS Screen Uniformity.

11. Modifications in the Assessment Categories Used in Medical Reports

FDA approved two alternative requirements dealing with the content of the medical report on August 29, 2003. They became effective on that date. They do not have a time limit. One of these adds a new assessment category for use in the reports of the mammography examinations and also adds clarifying language to the existing assessment categories. The second adds a reference to the possible need to obtain prior mammograms in order to make a final assessment.

The original standards are 21 CFR 900.12(c)(1)(iv) and (v), which state:

21 CFR 900.12(c)(1): Medical records and mammography reports

…..
(iv) Overall assessment of findings, classified in one of the following categories:
(A) "Negative:" Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained)";
(B) "Benign:" Also a negative assessment;
(C) "Probably Benign:" Finding(s) has a high probability of being benign;
(D) "Suspicious:" Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;
(E) "Highly suggestive of malignancy:" Finding(s) has a high probability of being malignant:
(v) In cases where no final assessment category can be assigned due to incomplete work-up, "Incomplete: Need additional imaging evaluation" shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and...

The approved alternatives are:

21 CFR 900.12(c)(1): Medical records and mammography reports

…..
(iv) Overall assessment of findings, classified in one of the following categories:
(A) "Negative:" Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained)";
(B) "Benign Finding(s):" Also a negative assessment;
(C) "Probably Benign Finding(s):" Initial short-interval follow-up suggested. Finding(s) has a high probability of being benign;
(D) "Suspicious Abnormality:" Biopsy should be considered. Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;
(E) "Highly suggestive of malignancy:" Appropriate action should be taken. Finding(s) has a high probability of being malignant:
(F) "Known Biopsy Proven Malignancy:" Appropriate action should be taken.
(v) In cases where no final assessment category can be assigned due to incomplete work-up, "Incomplete: Need additional imaging evaluation and/or prior mammograms for comparison" shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and...

As was the case with the original standard, only the words in quotation marks are required to be included in the medical report when giving the assessment category or indicating that no final category can be assigned at the present time. The remaining language is intended to provide explanations of the categories in order to promote their consistent use. It is not required to be included in the medical report, although the interpreting physician may do so if he or she wishes.

12. Assessment category for "Post Procedure Mammograms for Marker Placement"

This alternative standard was approved and became effective on September 17, 2003. It has no time limit. This approved assessment category can only be used for a post procedure mammogram to confirm the deployment and position of a breast tissue marker. The lay summary, which must be provided to the patient, must be specific to the procedure. If the facility makes this post procedure examination part of the interventional study instead of a separately charged examination, then it does not fall under MQSA and the approved alternative standard does not apply.

The original standard is 21 CFR 900.12(c)(1)(iv), which states:

21 CFR 900.12(c)(1): Medical records and mammography reports

(iv) Overall assessment of findings, classified in one of the following categories:
(A) "Negative:" Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained)";
(B) "Benign:" Also a negative assessment;
(C) "Probably Benign:" Finding(s) has a high probability of being benign;
(D) "Suspicious:" Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;
(E) "Highly suggestive of malignancy:" Finding(s) has a high probability of being malignant:
(v) In cases where no final assessment category can be assigned due to incomplete work-up, "Incomplete: Need additional imaging evaluation" shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and...

The granted alternative is:

21 CFR 900.12(c)(1): Medical records and mammography reports

(iv) Overall assessment of findings, classified in one of the following categories:
(A) "Negative:" Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained)";
(B) "Benign:" Also a negative assessment;
(C) "Probably Benign:" Finding(s) has a high probability of being benign;
(D) "Suspicious:" Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;
(E) "Highly suggestive of malignancy:" Finding(s) has a high probability of being malignant:
(F) "Post Procedure Mammograms for Marker Placement"

(v) In cases where no final assessment category can be assigned due to incomplete work-up, "Incomplete: Need additional imaging evaluation" shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and...

13. System Artifact Testing at Remote Mobile Mammography Sites Where Film Processing Takes Place Using Processors Permanently Located at the Site.

This alternative standard was approved and became effective on December 14, 2004. It has no time limit. It covers the system artifact testing at remote sites where mobile mammography facilities utilize processors that are permanently located at those sites. The approved alternative permits a specially trained quality control technologist to make system artifact films and phantom images at remote processor sites used by mobile mammography facilities and submit them to the facility medical physicist for evaluation. This relieves the facility from the need to have the medical physicist visit each remote processing location as a part of the annual survey.

 Although this request was approved for a specific mobile facilities operator, it has been extended to cover any other mobile facility that elects to apply it and meets the conditions described below.

The original standard states:

 21 CFR 900.12(e)(5)(ix): System Artifacts. System artifacts shall be evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and shall be performed for all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. System artifacts shall also be evaluated for all available focal spot sizes and target filter combinations used clinically.

The above is required to be performed annually by a qualified mammography medical physicist under the following:

21 CFR 900.12(e)(9)(i): At least once a year each facility shall undergo a survey by a medical physicist or an individual under the direct supervision of a medical physicist. At a minimum, the survey shall include the performance of tests to ensure that the facility meets the quality assurance requirements of the annual tests described in paragraphs (e)(5) and (e)(6) of this section and the weekly phantom image quality test described in paragraph (e)(2) of this section.

The granted alternative is:

21 CFR 900.12(e)(9)(i): At least once a year each facility shall undergo a survey by a medical physicist or an individual under the direct supervision of a medical physicist. At a minimum, the survey shall include the performance of tests to ensure that the facility meets the quality assurance requirements of the annual tests described in paragraphs (e)(5) and (e)(6) of this section and the weekly phantom image quality test described in paragraph (e)(2) of this section. For mobile facilities using remote site processing, a mammography technologist at the facility will be trained by the medical physicist to produce the processor artifact test images at each remote site and will provide them to the medical physicist for evaluation during the annual survey.

Conditions of this alternative requirement are:

The medical physicist will train the mammography technologist in the procedures as outlined in the American College of Radiology (ACR) Mammography Quality Control Manual, 1999. The training will include the direct supervision of that mammography technologist while she carries out these procedures at a mobile mammography site. The medical physicist will also carry out the identical procedures at that site. These procedures are:

1. Expose and process two mammography films according to the artifact test procedure described in the 1999 ACR Manual in accordance with the medical physicist’s instructions.
2. Expose and process a phantom image.

The medical physicist will evaluate and compare all these test films produced by the mammography technologist and by the medical physicist. If the results are comparable and the medical physicist reaches the same conclusions after reading the films produced by the mammography technologist that would be reached reading the physicist’s films, then the mammography technologist is considered to be capable of producing adequate films for this test without direct supervision.

At least once a year, the physicist will perform all required annual survey items including the phantom image and artifact test at one location serviced by the medical physicist and will use the technologist’s ACR phantom and absorber materials to perform the on-site testing.Prior to this annual visit, the mammography technologist will take two artifact films using four cm of absorber provided by the physicist at each remote processing site. The films will be developed according to the procedures in the 1999 ACR manual. The artifact test procedures will be repeated for each target/filter combination and each processor used clinically at each site. The mammography technologist will also take a phantom image at each site using the facility’s ACR phantom. The images taken by the mammography technologist at the remote sites will be brought to the chosen annual survey site for evaluation by the medical physicist during the annual survey. Applicable records for the physicist’s “Evaluation of Site’s Technologist’s QC Program” as described in the 1999 ACR Mammography Quality Control Manual, will also be provided from each remote site for the physicist’s review.

14. System Artifact Testing of Target Filter Combinations

This alternative standard was approved and became effective on June 16, 2005. It has no time limit. It covers the system artifact testing various target filter combinations. The approved alternative permits the system artifact test to be performed without testing all target filter combinations during the annual physics survey.

The alternative standard covers any facility that elects to apply it and meets the conditions described below.

The original standard states:
21 CFR 900.12(e)(5)(ix): System Artifacts. System artifacts shall be evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and shall be performed for all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. System artifacts shall also be evaluated for all available focal spot sizes and target filter combinations used clinically.

The granted alternative is:
21 CFR 900.12(e)(5)(ix): System Artifacts. System artifacts shall be evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and shall be performed for all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. System artifacts shall also be evaluated for all available focal spot sizes, targets, and filters used clinically.

Conditions of this alternative requirement are:

• The alternative is granted when testing for the annual physics survey only
• When following the alternative, if any filter-related artifact is discovered during the test then all clinically used target filter combinations as specified under the current regulation must be tested
• When conducting a mammography equipment evaluation (MEE), all clinically used target filter combinations must be tested