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

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