Argus banks on regulation trend with mammography QA software

QCWatch helps mammography sites comply with MQSA

A California software developer hopes that the growing trend toward accreditation and regulation of medical imaging equipment can work to its benefit. Argus Software of Redwood City, CA, has developed quality-assurance software that allows mammography facilities to track the performance of their equipment, thus ensuring compliance with Mammography Quality Standards Act (MQSA) regulations.

Argus was founded in 1992 by Richard Stark, a clinical medical physicist with experience in conducting quality-assurance checks for radiation oncology equipment in preparation for regulatory submissions. Because there was no dedicated software program available at the time, Stark found himself using multiple off-the-shelf software applications, such as word-processing programs and spreadsheets, for different aspects of the quality-assurance process.

Considering this approach cumbersome and redundant, Stark decided to build a better software mousetrap. The resulting product, QC4, manages the quality-control data generated during the testing of radiation oncology equipment and incorporates those data into a single package. Stark formed Argus to market the software, which has an installed base of close to 200 systems.

Argus several years ago decided to branch out of radiation oncology and into medical imaging, and chose mammography as its next target market, due to the quality-assurance requirements imposed on mammography facilities by MQSA, which was enacted in 1992. MQSA requires mammography sites to keep their equipment maintained to the act's specifications, and also contains provisions covering center operations, such as patient follow-up and tracking.

"MQSA requires specific testing, something on the order of 25 tests, some of them daily, that need to be run to make sure that the mammography unit is providing the best image quality possible and reducing the risk of misdiagnosis or delayed diagnosis," Stark said. "We felt that there was a need in that market to comply with regulatory authorities, as well as be able to guarantee to the highest degree possible the best image quality."

Argus is developing QCWatch to help mammography centers comply with MQSA regulations. The software package consists of two modules: MSpec, which automates the process of maintaining equipment, and MTrac, a mammography information system. MSpec began shipping in May, while MTrac is still under development.

Argus plans to offer the modules individually or as part of an integrated QCWatch package when MTrac becomes available sometime in 1998. The software runs on Windows 3.1, Windows 95, Windows NT, and Macintosh platforms, and can be installed on computers ranging from a laptop to a network. The list price of QCWatch varies depending on the number of systems in a facility; Argus estimates that a QCWatch package for a center with one mammography system would be priced at $4000 plus installation and training, not including computer hardware.

MSpec allows users to track factors such as kVp and mA settings, screen-film cleanliness, patient dose, and phantom image-test quality. Users are able to establish baseline equipment performance parameters and the frequency that their equipment should be checked, and are warned automatically if their equipment fails to meet preset conditions. The software also allows users to track equipment performance over time, alerting users if the performance begins to degrade or if the system goes out of compliance with MQSA regulations.

MTrac will apply to the center operations side, enabling centers to automate functions such as entering findings from mammography studies, patient tracking and follow-up, letter generation to referring physicians and patients, and tracking radiologist film interpretations and how they compared with pathology results. Argus plans to show a beta version of MTrac at this year's Radiological Society of North America meeting. Argus believes that MSpec is one of the only equipment quality-assurance software packages available in the modality, and will give Argus a distinct selling point when the company begins selling bundled QCWatch packages.

Argus is selling QCWatch directly but is also seeking OEM agreements with mammography vendors, and has hired former Nuclear Associates executive Harris Targovnik as director of business development to spearhead this effort. Argus believes that mammography vendors could bundle QCWatch with new mammography systems, thus giving customers an efficient means of keeping their equipment performing at the same level as when it left the factory. The company is also amenable to developing customized versions of QCWatch that could be integrated with information systems developed by other companies.

In the future, Argus plans to examine other imaging modalities for its quality-assurance software. Two modalities, ultrasound and MRI, are in the midst of accreditation efforts led by academic societies, similar to what occurred in mammography before the federal government stepped in. Argus sees the increasing role of regulation in healthcare as a definite business opportunity, according to Targovnik.

"The core functionalities and capabilities of the software can be moved over into other areas, like diagnostic radiology, fluoroscopy, MR, CT, ultrasound. These are all areas that we are investigating now and plan to pursue in time. Some of the things that drive the decision are regulatory issues," he said. "There is definitely a growing (regulatory) trend, and (authorities) are tying it in not just to regulatory issues but to reimbursement issues too."