Minimum Essential Characteristics_Advanced 3D Imaging Software System.docx

Minimum Essential Characteristics (MECS) Advance 3D Imaging Software System

The contractor shall deliver software and configure it as necessary to establish connectivity throughout the infrastructure. The ultimate service goal is to consolidate site local PACS to a Hub and Spoke model throughout the enterprise to provide standardization across the DHA. This task includes but is not limited to:

· Implementation at government hosted virtual environment

· Standardize system configurations

· Fully integrate to the PACS desktop

· Utilize a Web version of the client to allow reconstructions without limitation of location with thick client.

Delivery and configuration of software

1. System must have the capability to display at least two different series of images that has the ability to be locked and correlated for side-by-side comparison and scrolling with appropriate scaling.

2. System must have the ability to calculate and display Standard Uptake Value (SUV) measurements, to include SUV max and SUV lean, converted from recorded counts per voxel / Volume of Interest (VOI) to activity per unit volume with SUV calculations. System must include support to the following- but not limited to PET tracers (F18; Ga68; Rb82; Cu64; 90Y; 89Zr) and non-PET radionuclides (67Ga, 166Ho, 123I, 131I, 111In, 81mKr, 177Lu, 99mTc, 201Tl, and the dual isotopes).

3. System must have the capability to process and display static and dynamic planar nuclear medicine images, should include- but not limited to: whole body images, brain, brain metabolism, cerebrospinal fluid, thyroid, lung, lung quantification, gastrointestinal, genitourinary, gastric emptying, hepatobiliary, spleen, skeletal, lymphatic, oncologic, cardiac, gated studies, and all hybrid display combinations.

4. System must be capable of providing a toolkit for reconstruction / processing of images to include quality control, attenuation and scatter correction, motion correction, reconstruction with collimator response, 3D zooming, post-filtering reorientation, and attenuation map registration.

5. System must have the capability to adjust the lookup table / window settings, with the capability to manually adjust upper and lower thresholds (window) limits.

6. System must be capable of processing Myocardial Perfusion Imaging (MPI), perform quantitative cardiac segment to score myocardial perfusion in measurements of Summed Stress Score (SSS), Summed Rest Score (SRS), and Summed Difference Score (SDS), process and calculate Coronary Flow Reserve (CFR) and Coronary Artery Calcium (CAC) for each coronary artery, and process gated imaging to evaluate wall motion and ejection fraction. Capability should include support to the following radionuclides- but not limited to: F18; Tc99m; Rb82; and N13.

7. System must be capable of performing brain quantification measurements on brain SPECT and brain PET images, along with the capability to compare to a normative database for brain metabolism- Fluorodeoxyglucose (FDG), Positron Emission Tomography (PET) images. Could include overlay of subtraction image with MR scan for subtraction analysis.

8. System must be capable of processing multimodality lung images, Computed Tomography (CT), Single-Photon Emission Computerized Tomography (SPECT, Magnetic Resonance Imaging (MRI) and PET to calculate lobe function and volumetric anatomy, pulmonary segmentation, calculate and display histograms of V/Q (Ventilation/perfusion) frequency distributions and quantitative values to assess for parenchymal lung disease or pulmonary embolism.

9. System must have the capability to display at least two different Nuclear Medicine studies that have the ability to be locked and correlated for side-by-side comparison while displaying SUV measurements.

10. System must have the capability to display and overlay images obtained in Nuclear Medicine along with images obtained from another modality. The fusion of these images must allow for anatomy on the images to be correlated to allow for hybrid viewing. Displayed images must allow for the capability to zoom and reorient images."

11. System must have the capability to calculate quantitative measurements and display radiation energy that is deposited in the tissue(s) / organ(s) / region(s) of focus on Nuclear Medicine images to allow for dose calculation.

System must be capable of calculating dose distribution for the whole body or a single organ and provide a voxel-wise dose distribution calculation.

12. System must be capable of providing a consistent workflow for Selective Internal Radiation Therapy (SIRT) to include the ability to perform dose planning to determine activity required to achieve a therapeutic dose and process dose verification to assess radioactive spheres to confirm location of the administration of the therapeutic dose.

13. System must have the capability to detect and process images with dedicated algorithms in relation to anatomy and type of study; to include the abilities to overlay several modalities, automatic co-registration of different modalities, local co-registration between different modalities, one-click lesion segmentation, simple semi-automatic organ segmentation, automatic volumetric measurements on PET and SPECT and other modalities, volumetric lesion measurements, automatic transfer (copy/paste) of 3D regions between modalities. System must have the capability to identify and track lesions to allow for comparison and evolution of lesions over time.

14. System must have the capability to identify lesion segmentation and volumetric lesion measurements.

15. System must have the capability to redraw any regions of interest or adjust any calculations or measurements performed during the initial image post-processing if the initial regions of interest or calculations are determined to be inaccurate or misleading.

16. System must be capable of supporting advanced data analytics (machine learning / artificial intelligence) of stored data to assist in clinical decision support for patient care and population health.

17. System must have the ability to Auto-tracking of main and branch vessel coronary arteries throughout the cardiac phases to allow for production of curved MPR images.

18. System must have the ability to auto-trace vessels for diameter/stenosis assessment, aorta to peripheral vessels.

19. System must have the ability to perform Volumetric assessment of Left ventricular (LV) and Right ventricular (RV), Right Atrium (RA) and Left Atrium (LA) on CT using auto-tracking.

20. System must have the ability to perform Vessel stenosis analysis.

21. System must have the ability to perform Ability to construct cardiac structure in 3D environment.

22. System must have the ability to perform remove blood pool digitally.

23. System must have the ability to perform alter coloration of chambers, vessels, walls.

24. System must have the ability to perform alter transparency of chamber, vessels walls.

25. System must have the ability to perform alter lighting angle to provide best 3D rendering.

26. System must have the ability to One click reset to standard axial sagittal and coronal views.

27. System must have the ability to perform One click standard cardiac orientation to short axis, two chamber and four chamber configurations.

28. System must have the ability to perform Preset window level tool for myocardial perfusion analysis.

29. System must have the ability to perform accurate assessment of coronary artery calcium score (It should always be a whole number).

30. System must have the ability to perform 3-point delineation of the aortic valve annulus with ability to lock those points after screen manipulation.

31. System must have the ability to perform auto contouring tools.

32. System must have the ability to perform 3D left atrial appendage rendering w/ ability to measure and demonstrate projections.

33. System must have the ability to perform Ability to create bookmarks that can be accessed by all users to reproduce images.

34. System must have the ability to perform Ability to record moving renderings and transfer them into PACS.

35. System must have the ability to Reduce motion artifact.

36. System must have the ability to perform early, accurate detection of subdural hemorrhages.

37. System must have the ability to perform seamless care coordination for incidental cerebral aneurysms.

38. System must have the ability to perform Intracerebral Hemorrhage Detection & an algorithm that detects aneurysms in CTAs.

39. System must have the ability to perform Auto detection of Left ventricular (LV) and Right ventricular (RV)blood tissue boarders that require minimal user correction.

40. System must have the ability to perform T1, T2, T2* analysis tools with auto propagation of contours.

41. System must have the ability to perform Later Gadolinium Enhancement (LGE)mass analysis package allowing standard deviation, manual and full width half mass detection of LGE along with in image contouring for determination of left ventricular mass.

42. System must have the ability to perform MRI LV, RV, LA, RA strain to include longitudinal, radial and circumferential strain, auto calculate average strain and display in bullseye format.

43. System must have the ability to create bookmarks that can be accessed by all users to reproduce images.

44. System must have the ability to record moving renderings and transfer them into PACS.

45. System must have the ability to perform Large Vessel Occlusion (LVO) Detection automatically detects and triages suspected large vessel occlusions.

46. System must have a minimum 2-dimentional radiographic templating software compatibility within the PACS

Additional required Information

1. The contractor shall provide a detailed topography document to include details on how the enterprise system will be configured 30 days prior to Go-Live (Deliverable #1)

2. Go-Live shall implement the most current commercially available software version

3.. The contractor shall provide maintenance support for the enterprise software solution over the contract period

4. The contractor must include software updates and upgrades, to include all updates and upgrades to the clinical application, to ensure deployed version is the current commercially available software version.

5. Software updates and upgrades will not be made without the written approval from the designated Government’s official.

6. The contractor shall provide applications training for 400 individuals at the 12 PACS Hubs across the enterprise. Training shall be conducted one time in person on site (travel cost paid by contractor) and one time virtually per PACS Hub (12 in person trainings/12 virtual trainings). One virtual session shall be recorded and saved for future training purposes.

7. The contractor shall provide virtual trainings at each PACS Hub when an upgrade to the software application is applied.

8. The contractor shall assign a Project Manager (PM) within 30 calendar days after award.

9. The contractor shall deliver an overall project plan at proposal submission and within 30 days after award of the contract; with weekly updates until project completion. The detailed project plan shall highlight the key deliverables, timelines, and expectations of each party responsible for delivery, configuration, and final acceptance of the systems and provide weekly reporting regarding the status of each site’s progress. (Deliverable #2 and Deliverable #3)

The project plan shall include the start of delivery of software within 60 calendar days of award of the contract and installation shall begin within 90 calendar days of award. All sites must Go-live (clinically in use) within 12-months of contract award.

Business-to-Business (B2B) remote connection cannot be guaranteed, contractor should include costs for onsite installation and maintenance in the event B2B connection is not available or is not approved for a connection. The absence or lack of remote connectivity shall not delay implementation of system or configuration.

10. The contractor shall provide an implementation plan and implementation timeline for all sites.

Implementation plan shall include the following:

· Comprehensive implementation plan to install all systems, including total number of project managers and implementation team(s) involved.

· Proposed timeline for production Go-live for all implementations. “Go-live” date is met by full clinical usage of the system with fulfillment of migration requirements related to Go-live with no reliance on the legacy system.

11. The contractor shall attend weekly status meetings with the Government representatives; contractor shall provide meeting agenda 24 hours prior to meeting and provide meeting minutes within 48 hours of the meeting conclusion.

12. The contractor shall provide all the following, included in the setup/configuration of the system to ensure proper installation.

13. The contractor shall validate functionality of software in accordance with RMF accreditation documentation.

14. The contractor shall validate RMF STIG requirements and scan for vulnerabilities with DoD provided Nessus vulnerability scan software.

15. The contractor shall resolve or mitigate any Category 1 or High Category 2 vulnerabilities

16. The contractor shall upon site installation validate configuration is correct and working

17. The contractor shall agree to the DHA Cybersecurity/RMF requirements, receive an ATO and maintain the ATO for up to five (5) years in accordance with the contractual period of performance or as long as mutually agreed to by both parties. (Deliverable #7).

18. The contractor shall maintain an ATO on all product versions owned by the DHA and originally purchased through the awarded contract. If a contractor cannot support the ATO for all DHA owned versions of the product, the contractor can meet this requirement by offering to provide all upgrades to the product that are required to maintain the ATO for up to five (5) years in accordance with the contractual period of performance or as long as mutually agreed to by both parties. (Deliverable #7).

19. The contractor shall provide all costs/prices needed to meet the requirements in this document as part of their offer/quote and any items not included in the contractors offer/quote shall be offered at no cost for up to five (5) years in accordance with the contractual period of performance or as long as mutually agreed to by both parties. Contractors who cannot support all versions of the product and cannot offer upgrades required to maintain the ATO for up to five (5) years shall not be considered. Maintaining the RMF ATO shall be included as part of the contractor’s warranty period.

20. The contractor shall maintain the ATO; for up to five (5) years in accordance with the contractual period of performance or as long as mutually agreed to by both parties. If the patches are separate from updates as required by the contractor’s contract, the contractor shall offer the cybersecurity patches under a maintenance offering on their contract that provides for all required cybersecurity patches/updates needed to maintain the ATO.

21. The contractor shall agree to the DHA Cybersecurity requirements for all software purchased as part of this contract. Contractors may otherwise request an exception to cybersecurity policy. Exceptions to cybersecurity policy are contingent on approval by local and DHA CIO and Approving Official (AO).

22. The contractor shall agree to the DHA Cybersecurity requirements for all upgrades. Although there is an exception to cybersecurity policy process for upgrades similar to maintenance, the DHA does not envision granting exceptions to cybersecurity policy and would instead replace the software in lieu of approving upgrades that do not comply with cybersecurity policy.

23. The contractor shall ensure that personnel accessing information systems have the proper and current IA certification to perform IA functions at contract award in accordance with DoD 8140.03–M, IA Workforce Improvement Program. The contractor shall meet the applicable IA certification requirements as outlined in DFARS 252.239-7001, including.

24. The contractor shall have DoD-approved IA workforce certifications appropriate for each category and level as listed in the current version of DoD 8140.03–M.

25. The contractor shall have appropriate operating system certification for IA technical positions as required by DoD 8140.03–M.

26. Upon request by the Government, the contractor shall provide documentation supporting the IA certification status of personnel performing IA functions. Contractor personnel who do not have proper and current certifications shall be denied access to DoD IS for the purpose of performing IA functions.

28. All contractor employees that require access to DHA IT must comply with the requirements of DHA-Procedural Instruction 8140.01, Acceptable Use of DHA IT, to include those contract employees with privileged access.

29. The contractor shall provide vulnerability scan and SCAP scan results to Government on a monthly basis. Contractor shall provide raw scan results and administrative reports no later than the 10th calendar day of each month (Deliverable #6).