Every year, all 8,700 mammography clinics in the United States are inspected by the Food and Drug Administration (FDA). And on October 21, 2016, the FDA notified all mammography facilities that three questions are being added to annual Mammography Quality Standards Act (MQSA) inspections under a new program called EQUIP (Enhancing Quality Using the Inspection Program).
Approximately forty million women are screened using mammography in the US every year, with one to two per cent of those images being rejected on analysis due to poor image quality. Although this might not sound like much, it equates to between 400,000 and 800,000 women needing to be recalled for additional imaging. This is not only inconvenient for both the patient and doctor, but can also mean diagnosis and treatment could be delayed. In addition, it hits the mammography clinics bottom line as the additional imaging is not reimbursed.
EQUIP promotes clinical image quality by requiring all clinics:
- Establish and implement a regular image quality review process;
- Ensure corrective actions are in place, including extra training and process review; and
- Continue to comply with the standards of the accreditation body
Previously, compliance issues were largely found with the equipment and chemistry associated with the creation of film-based mammograms. Since mammography has now “gone digital” (film is rarely used in the US any longer), the problems of film-based technologies have also gone; the primary source of problems in mammography is now human error. EQUIP refocuses inspections towards human performance in digital imaging, and to sites’ processes and procedures around discovering human performance problems and mitigating them.
The EQUIP inspection questions will be asked during the annual FDA visits to each mammography clinic in the United States by the end of December 2017. Beginning in January 2018, the FDA will revisit each site and start issuing violation notices to clinical that are not compliant with EQUIP.
What EQUIP means for Volpara
VolparaEnterprise™ is the only solution for automated quality and review that helps with FDA EQUIP inspection compliance, while also improving business efficiency and workflow management.
VolparaEnterprise is unique because, unlike standard practice, it does not rely on random sampling or meticulous hand-kept lists of cases, but instead reviews the image quality on every mammogram. It finds patterns and common mistakes, letting managers focus precious training resources on the actual problems of human performance, ensuring more consistent and appropriate positioning and compression of the breast. The dynamic interactive dashboards within the VolparaEnterprise real-time quality assurance and performance monitoring software are updated with every new image acquired, and provide real-time metrics and KPIs to the clinic staff.
This is helpful in clinics regardless of size: small clinical may not have staff dedicated to compiling metrics, and very big clinics where tracking dozens of technologists and many interpreting physicians is very complete. VolparaEnterprise™ helps improve facility quality control processes, training regimes, improves patient comfort and ultimately results in better patient outcomes.
Outside of the US
Even though EQUIP is a US FDA initiative, other countries typically look to the US as a benchmark for the development of their own standards. In fact, EQUIP was a hot topic of discussion at the 2016 Radiological Society of North America (RSNA) conference in Chicago, which attracts a broad international audience.
However, it’s important to remember that while EQUIP has been a great conversation-starter for Volpara, it isn’t the sole reason that clinics purchase Volpara products.
Volpara originally developed VolparaDensity™, an automated, objective software which assesses breast density, a key risk factor for the development of breast cancer. The technology is so highly regarded that it has been included in the latest Tyrer-Cuzick risk assessment model. Volpara then applied that technology in the development of a product for assessing patient-specific x-ray dose. By working with leading tech giant Microsoft, Volpara was then able to evolve the density and dose products into a very broad and comprehensive enterprise analytics solution, and that led a natural transition from a capital based model to a Software as a Service (SaaS) subscription model.
Everything Volpara does moves the mammography world towards improved clinical decision-making and the earlier detection of breast cancer, improving patient outcomes and reducing the cost of breast cancer worldwide.