Revision History


Compliance with minimum frequencies and performance of QC tests as defined by the FDA’s Final Rule is a requirement for accreditation. A QC program must be implemented for all mammography systems and should be established with the assistance of a medical physicist. The ACR will give a new facility applying for accreditation a link to the 2018 ACR Digital Mammography Quality Control Manual. If you would like to start setting up your QC program before you receive the manual, all of the QC forms in the manual are available from the ACR Website. Facilities wishing to purchase additional copies may also do so through the ACR. For facilities that choose to use the manual provided by the mammography unit manufacturer, these forms are also available from the ACR Website.


Each facility must submit documentation of compliance for all QC tests as part of the application process. Both screen/film, FFDM and DBT versions of the required forms may be downloaded from the Technologist Quality Control Forms page of the ACR’s Accreditation website.


FFDM/DBT

The FDA requires that facilities with FFDM/DBT systems comply with a QC program that is substantially the same as that recommended by the image receptor manufacturer. Facilities have the option of following the QC outlined in the ACR’s 2018 Digital Mammography QC Manual instead of the manufacturer’s QC. The FDA approved the ACR’s alternative standard request to allow mammography facilities to use the Digital Mammography QC Manual and Digital Mammography QC Phantom in routine QC of digital equipment originally in 2016. The FDA subsequently approved the Digital Breast Tomosynthsis supplement in 2018.


If you choose to use your manufacturer manual, QC technologists and medical physicists should refer to the most recent version of their FFDM/DBT unit’s QC manual for specific tests, frequencies, and performance criteria. Note that the correct manual version may depend not only on the FFDM/DBT unit but also the software version of the unit. For Lorad FFDM/DBT systems, you may use any of the Lorad QC manuals that are applicable to your Lorad model - not necessarily the latest. If there are any questions, check with the manufacturer of your FFDM/DBT unit.


This requirement to follow the FFDM/DBT image receptor/film printer manufacturer’s QC also applies to review workstations (monitors) and film printers. However, the FDA allows some flexibility for workstation/printer QC depending on the device’s clearance from the FDA’s Office of Device Evaluation (ODE) for FFDM/DBT use. Facilities should check with their workstation/printer manufacturer for their device's FDA clearance status.


Workstations/Printers Approved by the FDA's ODE for Mammography

Workstations/Printers Not Approved by the FDA's ODE for Mammography

FDA considers the workstation/printer's QC manual to be "substantially the same" as that of the image receptor manufacturer and the facility may follow it for QC

The facility must follow the QC manual provided by the image receptor manufacturer (the facility should check with the image receptor manufacturer for their required tests)

Note that facilities are required to follow the testing requirements for film printers only on those days or weeks when they are actually printing out images. In the case of a facility that performs final interpretations using softcopy, the facility would only have to test the printer on those days/weeks when producing clinical hardcopy images for patients or healthcare providers or for retention purposes.


Facilities that Interpret Images via Hardcopy Only

For FFDM/DBT facilities interpreting images via hardcopy only, it is not necessary to have access to a review workstation or to submit the results of its Mammography Equipment Evaluation or QC testing for accreditation. Also, please note that any testing required by the manufacturer for the FFDM/DBT unit’s display is still required since the technologist clinically uses this display when performing the examination.


Technologists may contribute to the performance of QC; however, one technologist must be assigned the responsibilities of quality control. Other qualified individuals may perform specific QC tests but they must be reviewed and evaluated by the designated QC technologist. The designated lead QC technologist is responsible for ensuring that tasks are done properly by standardizing test methodology, reviewing all data, overseeing repeat testing before calling the medical physicist or service personnel, etc.


Mammography Equipment Evaluations

Under the FDA’s Final Rules for Mammography, the medical physicist is required to perform a Mammography Equipment Evaluation when a new unit or processor is installed, a unit/processor is disassembled and reassembled in the same or a new location, or major components of a mammography unit/processor equipment are changed or repaired. This applies to screen-film, FFDM and DBT units and includes previously owned units, accredited units moved from one site to another, and new units replacing previously accredited units. The Equipment Evaluation must determine whether the new unit meets the FDA’s equipment requirements (section 900.12(b)) and quality assurance requirements (section 900.12(e)). All problems must be corrected before the new/changed equipment is put into service for examinations or film processing and before the facility may apply for accreditation of a new unit.


It is not necessary to notify the ACR of changes in equipment (e.g. installation of a new processor, replacement of an x-ray tube); however, your medical physicist must conduct a Mammography Equipment Evaluation (and all applicable tests must pass) before you may use the unit to examine patients. See the FDA's Policy Guidance Help System for specific guidance on appropriate tests.


Mammography Equipment Evaluation results must be submitted to the ACR on the MQSA Requirements for Mammography Equipment Checklist and the Medical Physicist Mammography QC Test Summary, which may be downloaded from the ACR website. Handwritten or faxed summaries are acceptable. Be sure that all requirements pass before submitting the application. It is important to note that summaries submitted in different formats will delay the ACR’s review even if they contain all of the required information.

  • MQSA Requirements for Mammography Equipment: The ACR has developed this simple checklist to help medical physicists document section (b) of the FDA regulations. The medical physicist should complete all applicable sections of the checklist, indicating “Not Applicable” where appropriate. If “Not Applicable” is marked, a reason should be provided.

  • Medical Physicist's Mammography QC Test Summary (Unit-Manufacturer-Specific): As noted above, section (e) of the FDA regulations requires the medical physicist to follow a quality assurance program that is “substantially the same as the quality assurance program recommended by the image receptor manufacturer.” This complicates the testing since the tests, frequencies, and pass/fail criteria vary across manufacturers, models, and QC manual versions. To simplify this documentation, the ACR developed this short form. These ACR forms are routinely updated as the manufacturers update their QC manuals and are available on the ACR website on the Mammography Forms Page. The QC form names on the website include the revision date so you may easily determine if you have the latest version. The FDA requires the ACR to collect and review this information as part of accreditation. Please note that for QC requirement changes based on software updates, equipment manufacturers provide the QC data forms in their manuals. Complete the relevant form for screen-film or full-field digital mammography as applicable. Because an Equipment Evaluation is performed before a mammography unit is used clinically, a medical physicist is not required to complete the “Evaluation of Site’s Technologist QC Program” section of the form during the Equipment Evaluation. Your medical physicist will need to evaluate your facility’s QC program and complete this section of the QC Test Summary within the 45 days you are provided to obtain the clinical and phantom images, as part of the new unit’s Annual Survey Report submitted to the ACR with the full application and/or testing materials.


You do not need to submit the entire Equipment Evaluation report at this time, nor does your medical physicist need to leave a copy of his/her Equipment Evaluation results before he/she leaves your facility after the survey (he or she may need to take the raw test data and films back to his/her office for analysis). However, your medical physicist must provide you with the written pass/fail Equipment Evaluation summary as soon as possible so that you can include it with your application to the ACR. The medical physicist may fax or e-mail this summary to you. If this is a new unit at an existing MQSA-certified facility, you may not start using the unit until you have received written Equipment Evaluation results from the medical physicist showing that all items have passed, and you have sent the Equipment Evaluation results to the ACR with all required application materials. You may not start using the equipment to examine patients based on a verbal indication from the medical physicist that all items passed.


The medical physicist should check that all required QC tests are done by the QC technologist initially and then at the FDA-mandated frequencies. The ACR does not require the medical physicist to evaluate a certain number of days of QC. The ACR recognizes that, if this is a unit’s first survey, the medical physicist can only evaluate the number of tests that have been performed since the unit was installed. Note that the medical physicist need not evaluate the technologist’s QC program in person; review of the facility’s QC program may be done remotely by mail or fax.


ACR staff who are experienced mammography technologists with advanced registries in mammography review the medical physicist’s pass/fail Equipment Evaluation summary. They check to verify that the Equipment Evaluation was performed no earlier than 6 months before the date of application, that the medical physicist has evaluated each applicable FDA-required item, and that each item has passed. If the medical physicist fails an item, ACR staff will check that the facility has provided appropriate documentation of corrective action (e.g., the medical physicist’s re-evaluation, a service ticket, etc.). If the required item was not evaluated by the medical physicist or if the item failed and no corrective action was provided, ACR staff will call and/or contact the facility in writing for the missing information. The application will not be processed until all information is complete.


Annual Medical Physicist’s Survey

The medical physicist must perform the manufacturer-specified QC or the QC outlined in the 2018 ACR Digital Mammography QC Manual or the unit manufacturer’s QC Manual when equipment is installed and at least annually thereafter. The medical physicist should provide a written report of the survey’s findings to responsible physician(s) and professional(s) responsible for service of the equipment. Although FDA regulations allow the medical physicist 30 days from the date of the survey to send a report, a 30-day delay in getting the report to the facility allows the facility no time to take corrective actions. The ACR strongly recommends that written reports be submitted in time to give facilities the opportunity to take corrective actions in case of an adverse finding.


The medical physicist must summarize the Annual Medical Physicist’s Survey results on the Medical Physicist Mammography QC Test Summary Form.


The facility must submit the entire, most recent medical physicist’s Annual Survey Report within 45 days of submitting the initial application. In the case of a new unit, this Annual Survey report will generally include the Equipment Evaluation report. As described above, the following 2 forms must be completed by the medical physicist and included with the full report:

  • MQSA Requirements for Mammography Equipment

  • Medical Physicist's Mammography QC Test Summary (for screen-film, FFDM or DBT, as applicable). It is important to note that the medical physicist must now complete the “Evaluation of Site’s Technologist QC Program” section of this form.


A medical physicist may choose to conduct Annual Surveys for different units at the same facility on different dates during the year; however, he or she may review the entire facility’s QC program once a year. In such cases, the medical physicist may complete only the ‘Evaluation of Site’s Technologist QC Program' section of the QC Test Summary on one unit, as long as he/she indicates where and when the results of the technologist QC program evaluation were recorded. For example, if the technologist’s QC for the entire facility was evaluated during the January 15, 2019 Annual Survey of Unit #1, and Unit #2 was tested on April 15, 2019, the medical physicist may indicate “see January 15, 2019 Annual Survey Report for Unit #1” on the “Evaluation of Site's Technologist QC Program” page of Unit #2’s Annual Survey Report. He/she should not indicate “N/A” for these evaluations.


QC Record-Keeping Requirements

FDA rules require that QC records be “maintained until the next annual inspection that would verify compliance or until an individual test has been performed 2 additional times at the required frequency, whichever is longer. Verifying compliance implies that if QC records for a given test were found to be deficient and the facility was cited during an annual inspection, these records must be kept until the facility corrects the problem to the FDA’s satisfaction. This also means that records for semiannual tests may have to be kept longer than the period between 2 successive annual inspections, and records for annual tests must include the most recent 2.” See the FDA's Policy Guidance Help System for more information. Individual state laws may impose more stringent requirements for QC record retention. Facilities should check with their state for any requirements.


FDA Requirements for Mammography QC Test Image Retention

QC Images

Retention

Daily QC

Previous 30 days

Weekly QC

Previous 12 weeks

Monthly QC

Until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements

Quarterly QC

Semi-Annual QC Tests

Until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed 2 additional times at the required frequency, whichever is longer

Annual QC Tests

Not required by FDA; the ACR recommends that images documenting test failures be provided to the facility to assist them in making corrective actions


Mammography Equipment Evaluations






Revision History for this Article

Date

Section

Description of Revision(s)

12-12-19

All

Article created; FAQs incorporated; No criteria changes



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