ATTACH 1 - MRS Requirements.pdf

Attachment 1

Mammography Reporting System (MRS) Requirements

1. The mammography reporting system must have an historical database to incorporate patient visits, generate reports for patient follow-ups, and generate reports compliant for annual FDA inspection(s).

2. The MRS shall include a lifetime breast cancer risk calculation/assessment tool in accordance with regulatory requirement, Mammography Quality and Standards Act

(MQSA).

3. The MRS must support regulatory requirements for MQSA and American College of Radiology Breast Image Reporting and Data System (ACR BI-RADS) found at https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mammography-quality-standards-act-mqsa and https://www.acr.org/Clinical-Resources/Reporting-and-Data- Systems/Bi-Rads.

4. The MRS shall provide a web-based application for the patients to access and update historical and pertinent information for the requested study.

5. The MRS shall provide a web-based application for the radiology technologist(s) to assist in updating patient information and managing that information in the database.

6. The MRS shall integrate with AGFA, FUJI, and Change Healthcare Picture Archiving and Communications System (PACS) client viewer that the radiologists use for syncing patient information for the displayed study in PACS for historical and statistical patient information. Historical information needs to be accessible from the previous reporting system and must comply with the current system format.

7. The MRS must provide efficient statistical analysis of mammography metrics to include cancer detection rates, callback rates, etc. required for FDA compliance.

8. The MRS must be able to trace and differentiate radiologists as the primary reader, additional reader (second read), and comparison study numbers for numerous exams to maintain the radiologists’ credentials and FDA/MQSA (requirement of 960 exams in a 2-year period).

9. The MRS must be able to generate reports tracking the number of exams performed per radiology technologist to maintain FDA compliance.

10. The MRS must efficiently separate categories of exams (e.g. Screening only, Diagnostic only) for medical audit.

11. The MRS must efficiently generate radiologist recall rate data.

12. The MRS must efficiently track pathology results and reporting.

13. The MRS shall provide a web-based client that has reporting solutions for comparison study interpretation and be capable of uploading the reports into MHS Genesis for the radiologist(s).

14. The MRS must have an authorized bidirectional connection with the MHS Genesis to obtain a worklist and upload breast imaging reports and their interpretation.

15. The MRS shall be able to validate and normalize databases contained in Volpara, Mammstats, Magview, Penrad, Omnicare for migration and database consolidation.

16. The MRS must be able to attain and maintain the required Authority To Operate (ATO) as established by DoD cyber security. These requirements are worked through in the DHA Risk Management Framework (RMF) process. More information on the RMF

Process can be found at https://securityawareness.usalearning.gov/rmf/index.htm, https://www.health.mil/Military-Health-Topics/Technology/Risk-Management-Framework and/or Attachment 2 of this RFI titled DHA RMF Process Workflow.

17. The MRS must integrate with PowerScribe 360 to prepopulate the enterprise dictation template with patient’s history and risk factor information.

18. The MRS must have a process such as a web-based application or access for print-outs that can be used to provide thorough accurate details on breast tissue density results to educate patients on such results.

19. The MRS must provide ongoing software support through Service Maintenance Agreement (SMA) Monday through Friday 5am to 5pm PST to include upgrades and updates regardless of location.

20. The MRS must be HIPAA Compliant.