News | Breast Imaging | November 08, 2016

VolparaEnterprise Software to Help Breast Imaging Providers Comply With New FDA Quality Initiative

Volpara’s “EQUIP-ready” support program will help accredited breast imaging centers meet requirements of recently enacted Enhacing Quality Using the Inspection Program (EQUIP) initiative

Volpara Solutions, VolparaEnterprise, breast imaging software, EQUIP-ready support program, FDA, Enhancing Quality Using the Inspection Program

November 8, 2016 — Volpara Solutions announced the launch of a support program to help accredited breast imaging centers across the United States prepare for compliance to the U.S. Food and Drug Administration’s (FDA) Enhancing Quality Using the Inspection Program (EQUIP) initiative. The Volpara "EQUIP-ready" program — which includes draft processes, procedures and forms designed to help users accelerate their compliance efforts — is included with the company's Volpara Enterprise cloud-based quality assurance solution.

The EQUIP initiative, launched on Oct. 27, 2016 to coincide with the 25th anniversary of the passage of the Mammography Quality Standards Act (MQSA), emphasizes "the need for ongoing facility review of clinical image quality." Beginning in 2017, accredited breast screening providers will have to address three new questions to ensure compliance with regulations relating to quality assurance in the FDA's annual facility inspections. Every facility will need to demonstrate that it has:

  1. A corrective action system that can address when clinical images are of poor quality;
  2. A means of establishing that clinical images continue to comply with the standards of its accreditation body, including quality attributes such as positioning, and include regular reviews of sample images from each technologist and each interpreting physician; and
  3. A procedure for oversight of quality assurance/quality control (QA/QC) records and corrective actions.

VolparaEnterprise software — which delivers key performance indicators (KPIs) for hundreds of performance and quality metrics, including positioning, compression and equipment utilization — is designed to help sites prepare for the EQUIP inspection questions:

  • The software monitors every screening mammogram for image quality issues related to positioning and compression;
  • VolparaEnterprise data's easy sorting by technologist helps isolate cases for EQUIP review; and
  • It can help rapidly locate poor quality images for review during Image Review Quality Meetings (as well as good-quality images for review in preparation for machine accreditation).

Designed to support large or small enterprises, VolparaEnterprise software enables breast imaging providers to provide objective evidence to demonstrate compliance and quality of care. Users can perform rapid quality control checks to optimize the productivity and efficiency of imaging resources, to help reduce costs through the reduction of retakes, and to increase staff effectiveness. The Microsoft Azure–based solution provides real-time quality assurance and performance monitoring through dynamic, interactive dashboards. 

For more information: www.volparasolutions.com

Related Content

QView Medical Showcases QVCAD for ABUS Exams at RSNA 2018
News | Ultrasound Women's Health | November 19, 2018
QView Medical will showcase QVCAD, the first U.S. Food and Drug Administration (FDA)-approved artificial intelligence (...
Lunit Unveiling AI-Based Mammography Solution at RSNA 2018
News | Mammography | November 15, 2018
Medical artificial intelligence (AI) software company Lunit will be returning to the 104th Radiological Society of...
Breast Density Advocate Nancy M. Cappello Passes Away

Nancy Cappello. Image courtesy of AreYouDense.org.

News | Breast Density | November 15, 2018 | Jeff Zagoudis, Associate Editor
Imaging Technology News extends its condolences to the family, friends and colleagues of Nancy M. Cappello, Ph.D., who...
Merit Medical Completes Acquisition of Cianna Medical
News | Women's Health | November 14, 2018
Disposable device manufacturer Merit Medical Systems Inc. announced the closing of a definitive merger agreement to...
The MOZART Supra Specimen Tomosynthesis System is the latest generation of 3-D imaging for breast cancer surgery.
News | Breast Imaging | November 08, 2018
KUBTEC announced the launch of a new innovation in the treatment of breast cancer. The Mozart Supra Specimen...
Feature | Breast Imaging | November 07, 2018 | By Jeff Zagoudis
Breast imaging technology has experienced major growth over the last decade or so, and a new report suggests the mark
Philips’ Compressed SENSE technology helps shorten MRI exams by eliminating redundant radiofrequency signals from the acquisition phase. The software reconstructs any missing  information to maintain high image quality. (Images courtesy of Philips/University Hospital Cologne)

Philips’ Compressed SENSE technology helps shorten MRI exams by eliminating redundant radiofrequency signals from the acquisition phase. The software reconstructs any missing information to maintain high image quality. (Images courtesy of Philips/University Hospital Cologne)

Feature | Breast Imaging | November 05, 2018 | By Jeff Zagoudis
The incidence of breast cancer is rising globally, with an estimated 1 in 8 women diagnosed in their lifetime and 40,...
Deaconess Health System Chooses Sectra as Enterprise Imaging Vendor
News | Enterprise Imaging | November 02, 2018
International medical imaging information technology (IT) and cybersecurity company Sectra will install its enterprise...
Volpara Enterprise Cloud Reaches 1 Million Mammograms Stored
News | Mammography | October 31, 2018
Volpara Solutions announced that the data stored in the Volpara Enterprise cloud now exceeds 1 million mammographic...