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QC-Track Module:   Mammography

Reminder:

The FDA’s Policy Guidance Help System indicates that electronic QC records are acceptable in MQSA inspections under the following conditions:
  1. The data is easily accessible for review by the inspector
  2. The facility has the ability to print a hardcopy of the records, if requested
  3. The records must be maintained for the time frame required by the regulations

For more details, see the Policy Guidance Help System, specifically numbers 1, 3, and 5.
QC-Track was originally designed to meet the challenges of MQSA device QC. Introduced at RSNA 2008, QC-Track is now proven every year in MQSA inspections across the U.S.
Structured Workflow
QC-Track worksheets, designed to follow the manufacturer’s QC requirements, are available for:
  • FDA-cleared DBT and FFDM systems, including Hologic, GE, and Siemens
  • Imaging accessories, including monitors and digitizers
  • Related imaging units found in many women’s imaging centers, including stereo biopsy units, DXA systems, MRI units, and ultrasound systems to provide all of the tracking needed in ACR "Breast Imaging Center of Excellence" (BICOE) sites
  • Advanced reporting and tracking needs, such as center-wide tracking and reporting

Reports
The full collection of MQSA and vendor-required reports is included with QC-Track.
  • Assemble reports as full MQSA device QC inspection packages.
  • Present reports that have a clean and consistent look.
  • Email reports to inspectors or service engineers - no more faxing out of binders.

Electronic Sign Off, including FDA EQUIP
Sign-offs can be set up for Responsible Parties so they can review and sign off at their convenience from anywhere on the facility’s network. QC-Track now supports the EQUIP process. To see how, view our infographic.

Comprehensive QC Program? See also:
  • Credentials -- to track and report CEU/CME and Exam counts by modality
  • Event Tracking -- to notify, schedule, and track ongoing location and device QC events
  • Document Tracking -- to centrally store, manage and quickly access the entire range of QC documents

Related Brochures
Licensing
Standard QC is licensed by imaging unit and location.
  • Pre-Requisites: none
  • Restrictions: none

Other Resources
ACR
The ACR Continuous Quality Control (CQC) program specifies clinical professional qualifications and service document requirements within their ACR Mammography Accreditation Program Requirements. See ACR Mammography Accreditation Page for more information.

  Atirix products are covered by issued and pending patents, including US 8,478,610 “Medical Imaging Device Quality Control System and Method” and US 8,428,969 “System and Method for Tracking Imaging Quality”
© 2018 Atirix Medical Systems, Inc. All Rights Reserved.  
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