News | Mammography | September 01, 2017

FDA Releases Six-Month Inspection Data From EQUIP Mammography Quality Initiative

Nationwide survey reveals nearly half of all inspections had one or more deficiencies related to mammography quality assessment processes

FDA Releases Six-Month Inspection Data From EQUIP Mammography Quality Initiative

September 1, 2017 — The Division of Mammography Quality Standards (DMQS) of the U.S. Food and Drug Administration (FDA) released new data from an analysis of inspections performed under the Enhancing Quality Using the Inspection Program (EQUIP) initiative. All data was collected from Jan. 1, 2017, through June 30, 2017.

Announced by the FDA in October 2016, the EQUIP program was created to ensure mammography facilities are adhering to the highest standards when assessing the quality of their mammograms. The program added three questions to the regular inspection process and eliminated two.

During this first year of inspections that include the EQUIP questions, facilities will not receive citations related to the new EQUIP questions. However, inspectors are responsible for recording facility responses to the EQUIP questions and any deficiencies are noted on the post-inspection report. These are then discussed during the inspection close-out session so that facilities are aware of what would have been cited if citations were in effect. This provides facilities with the opportunity to address these deficiencies prior to inspection citations being issued, beginning with inspections performed on or after Jan. 1, 2018.

As of June 30, 2017, there have been 4,166 annual MQSA inspections performed under the EQUIP initiative. Overall, 44 percent of those inspections had one or more EQUIP deficiencies. The chart below shows a breakdown of how many deficient inspections were recorded for each EQUIP sub-question. The highest number of deficient inspections was related to sub-questions 2(a) and 2(b), which cover the periodic image quality review.

EQUIP Question
No. of Deficient Inspections
Percent of Total Inspections

Question 1(a) - There is no system in place that includes a mechanism for providing ongoing IP feedback on image quality
542
13%

Question 1(b) - There is no system in place that includes a mechanism for documenting any needed corrective action and the effectiveness of any corrective action taken
1,045
25%

Question 2(a) - There is no mechanism in place for regular reviews of image quality attributes of a sample of mammograms performed by each active RT and a sample of mammograms accepted for interpretation by each active IP
1,421
34%

Question 2(b) - There is no documentation of review since the last inspection
1,263
30%

Question 3(a) - There is no system in place for LIP oversight, including review of the frequency of performance of all required tests
803
19%

Question 3(b) - There is no system in place for LIP review to determine whether appropriate corrective actions were performed when needed
937
22%

The DMQS said it had anticipated that Question 2 might be the most difficult for facilities to meet, mainly due to the fact that while many facilities engage in daily feedback, not all of them take the opportunity to do an assessment of image quality for the facility as a whole, including all technologists and interpreting physicians in that assessment. This type of assessment allows the facility an overall look at the quality of the breast images it produces, as well as a look at the less-often-assessed quality of images that its interpreting physicians are accepting for interpretation. Image quality is a responsibility that should be shared by both technologists and interpreting physicians. Supplementing the daily feedback process with this type of assessment can potentially lead to systemic remedies that improve a facility’s image quality, according to the DMQS. Although the division encourages facilities to do this assessment more frequently, it must be done and documented at least once a year.

The agency note that the EQUIP questions are designed to check that processes are in place for this image quality review, not specific review details. Facilities are free to design processes that best fit their individual situations and practices. This flexibility allows for many different ways to successfully meet Question 2, as well as the other EQUIP questions, and thereby satisfy the EQUIP inspection questions.

DMQS encourages providers to please take time to engage with their inspector during this educational year to learn how EQUIP can help the facility maintain image quality. Beginning with inspections performed on or after Jan. 1, 2018, Level 2 citations will be issued to facilities who have not successfully implemented the processes covered by the EQUIP inspection questions.

For more information: www.fda.gov

Related Content

Theraclion to Launch Metastatic Breast Cancer Trial Combining Echotherapy and Immunotherapy
News | Focused Ultrasound Therapy | September 18, 2017
September 18, 2017 — Theraclion and co-lead investigator David Brenin, M.D., from the University of Virginia School o
DenseBreast-info.org Debuts  Spanish Language Video  About Dense Breasts
News | Breast Density | September 12, 2017
Breast cancer risks associated with breast density are the subject of a new Spanish language video launched recently by...
Asian Study Underlines Potential Value of Pressure-Guided Mammography
News | Mammography | September 11, 2017
Sigmascreening recently announced that a study of in total 15,898 in digital mammograms from 3,772 Asian women...
Delphinus Enrolls First Patient in Discover Breast Ultrasound Clinical Project
News | Ultrasound Womens Healthcare | September 08, 2017
September 8, 2017 — Delphinus Medical Technologies Inc.
Breast imaging X-ray mammogram showing a breast tumor. Photo courtesy of Monthian Ritchan-Ad

Photo courtesy of Monthian Ritchan-Ad

Feature | Breast Density | September 08, 2017 | By Roy Prager, M.D.
While mammograms play a vital role in efforts to identify breast cancer, they can present some challenges in women with...
FDA Clears Senographe Pristina Mammography System With Patient-Assisted Compression
Technology | Mammography | September 05, 2017
The U.S. Food and Drug Administration (FDA) cleared GE Healthcare’s Senographe Pristina with Self-Compression, the...
Hologic Announces Availability of Brevera Breast Biopsy System With CorLumina Imaging Technology
Technology | Breast Biopsy Systems | August 31, 2017
Hologic Inc. announced U.S. commercial availability of the Brevera breast biopsy system with CorLumina imaging...
China FDA Approves Xoft Axxent Balloon Applicators for Early-Stage Breast Cancer
News | Brachytherapy Systems, Women's Healthcare | August 30, 2017
iCAD Inc. announced that the company’s Xoft Axxent balloon applicators have received approval from the China Food...
Top list of stories, article, videos for breast imaging.
Feature | Breast Imaging | August 30, 2017 | Dave Fornell
August 30, 2017 — This is a list of the top breast imaging content so far for 2017.
Kubtec Introduces Automatic Specimen Alert to Mozart 3-D Tomosynthesis System
Technology | Breast Imaging | August 23, 2017
Kubtec announced that it has developed a unique solution to a potential problem faced by operating room (OR) staff when...
Overlay Init