HT9425-25-R-0072 Amendment 0002_ Advanced 3D Imaging system.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

1. CONTRACT ID CODE PAGE OF PAGES

J 1 11

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 22-Jul-2025

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X HT942525R0072

X 9B. DATED (SEE ITEM 11)

02-Jul-2025

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X X is not extended.The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this amendment is to update item # 27 and 37 of Minimum Essential Characteristics (MECs) and to extend solicitation response date/ time from 04-Aug-2025 12:00 PM to 06-Aug-2025 12:00 PM.

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO.

5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

22 Jul-2025

CODE

ARMY MED RES ACQ ACTIVITY

808 SCHREIDER ST

FORT DETRICK MD 21702

HT9425 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

HT942525R0072

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 04-Aug-2025 12:00 PM to 06-Aug-2025 12:00 PM.

The following have been modified:

MECS

Minimum Essential Characteristics: 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 Picture and Archiving System (PACS) to a Hub and Spoke model throughout the enterprise to provide standardization across the Department of Health Agency (DHA). This task includes but is not limited to:

i. Implementation at government hosted virtual environment not directly associated with any currently deployed PACS. This virtual environment will be used for the complete implementation of the solution to include training and RMF (if no current ATO). Remote-access solutions not hosted within the government hosted environment are not acceptable.

ii. Standardize system configurations throughout the DHA Enterprise

iii. Fully capable to integrate with the PACS desktop

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

A server-based client can be proposed however, the proposed solution must have a web client.

v. System shall be able to perform reconstructions of Computed Tomography (CT) and Magnetic Resonance

Imaging (MRI) exams with a volume of 450K exam yearly with image sets over 1K for studies.

vi. The location of the government hosted environment has not been determined at this time.

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

4. 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.

5. 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 Positron Emission Tomography (PET) and Single- Photon Emission Computerized Tomography (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.

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

7. 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.

8. REMOVED

9. 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

27. REMOVED

28. 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.

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

30. 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.

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

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

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

34. REMOVED.

35. REMOVED.

Additional required Information

36. The contractor shall provide a detailed topography document to include how the enterprise system will be configured and deployed with submission. The document will be updated to reflect any changes during implementation within 7-days after to Go-Live (Deliverable #1).

37. Must offer/implement the most commercially available software version and must have a DHA Enterprise level Authority to Operate (ATO) or obtain an ATO within 1 year from award. The entire solution must be commercially available solution at time of submission that meets or exceeds the standards in this MECS, no future features and functionality of the solution will be considered.

38. The contractor shall include maintenance support for the enterprise software solution over the contract period of 5 years.

39. The contractor must include software updates/upgrades, to include any professional services required. The application version deployed is the current commercially available software version.

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

41. The contractor shall provide applications training for up to 450 users (Radiologists 424, specialty providers and technologists) hosted at the 12 PACS Hubs across the enterprise onsite. The training curriculum will be the same regardless of user role. Training shall be conducted one time 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. Training rosters with names, signature and date will be provided at the conclusion of the training.

Number of concurrent radiologists per Hub are as follows:

i. Tripler Army Medical Center, HI: 20

ii. Brian D. Allgood, Korea: 16

iii. Evans Army Community Hospital, CO: 23

iv. Madigan Army Community Hospital, WA: 31

v. Brooke Army Medical Center, TX: 70

vi. Walter Reed National Military Medical Center, MD: 64

vii. Womack Army Medical Center, NC: 14

viii. Landstuhl Regional Medical Center, Germany: 30

ix. Blanchfield Army Community Hospital, KY: 20

x. Eisenhower Arch Community Medical Center, GA: 28

xi. Portsmouth Naval Medical Center, VA: 63

xii. Naval Medical Center San Deigo, CA: 55

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

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

44. Vendor shall conduct meetings weekly with project updates until project completion and provide weekly reporting regarding the status of each site’s progress.

45. The contractor shall deliver a draft project plan at proposal submission and final project plan within 30 days after award of the contract The contractor shall provide a detailed implementation plan and timeline for all sites at time of submission. (Deliverable #2).

Implementation plan shall include the following:

i. 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.

ii. 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 Comprehensive implementation plan to install all systems, including total number of project managers and implementation team(s) involved. Specify the number of resources required per task, how will the contractor mitigate issues as they arise and provide any known contractor dependances (limited resources, ATO, ability of personal to meet cyber security requirement, etc.)

iii. Detailed steps and task owners for implementation as well as expected completion time for each task.

iv. 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.

46. The contractor shall host 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.

Meeting minutes will be provided in PDF format.

47. The contractor can propose a Virtual Environment Host for testing if desired. The environment will be hosted by the government.

48. The contractor shall validate functionality of software in accordance with Risk Management Framework (RMF) accreditation documentation. RMF/ATO must continually be updated to meet the requirement of item number 4.

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

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

51. The contractor shall upon site installation validate configuration is correct and working. Once contractor confirms, official notification must be submitted to the contracting officer. DHA within 45 days perform acceptance testing (AT). If the solution has zero discrepancies during AT, warranty will start on the day the official notification was made to the contracting officer. If discrepancies are noted, warranty will start once the items are addressed by the vendor and confirmed by the government.

52. The contractor shall agree to the DHA Cybersecurity/RMF requirements, receive an ATO and maintain the ATO for 5-years in accordance with the contractual period of performance or as long as mutually agreed to by both parties. (Deliverable #3).

53. 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 5-years in accordance with the contractual period of performance or as long as mutually agreed to by both parties. (Deliverable #4).

54. 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 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 5-years shall not be considered. Maintaining the RMF ATO shall be included as part of the contractor’s warranty period.

55. The awarded contractor shall maintain the ATO; for 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.

56. REMOVED.

57. 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.

58. 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.

59. 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.

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

61. 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.

62. All contractor employees that require access to DHA IT must comply with the requirements of DHA-Procedural Enterprise.

63. 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 #5).

64. The contractor will submit drawing for/from RMF/ATO package to clearly demonstrate any 3rd party vendors being quoted are within the vendors boundary with submission (Deliverable #6).

65. Business-to-Business (B2B) remote connection cannot be guaranteed. At times the B2B may not be available due to a variety of issues. If this happens the contractor is still responsible to implement, and to maintain the up time of the system. If needed, the contractor will send someone to the site to address any issue. 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.

66. DHA will determine the need to perform Acceptance Testing at a single PACS hub or multiple hubs as the implementation progresses. Acceptance testing will be performed by Subject Matter Experts from the DHA PMO.

Testing will include validation of each MECS to ensure functionality and contract specification has been completed.

67. Must be capable of operating with a single DHA enterprise HIS/RIS (MHS Genesis/Cerner).

MILESTONE PERFORMANCE SCHEDULE

Advanced 3D Imaging System Month Tasks/Milestones Completed

Month

Kick Off Meeting with DHA PMO and vendor, project plan presented and agreed to by Govt and vendor.

Month 2 - 3

Kick Off meeting with PACS hubs, Network hosting team and software/licenses delivered

Month 4-9

Implementation and configuration of software PACS desktop integration configuration

Month

Configuration and integration testing with Super Users and DHA PMO

Month

System Administrator and User applications training

Month

System Go-live and DHA acceptance testing and validation (Refer to MECS #66)

Deliverables Schedule Deliverable Frequency Medium/Format Submit To Applicable to Deliverable #1:

Detailed topography

7 days prior to Go-Live Contractor’s discretion

COR and Site POC

MECs Additional required Information #36

Deliverable #2:

Detailed project plan/Site-by-site project plan

At proposal submission and within 30 days after award of the contract; and every 30 days until project completion.

Contractor’s discretion

COR and Site POC

MECs Additional required Information #45

Deliverable #3:

DHA

Cybersecurity/R MF requirements

Confirm in writing agreement with this statement at time of submission.

Contractor’s discretion

COR and Site POC

MECs Additional required Information #52

(End of Summary of Changes)

Deliverables Schedule Deliverable Frequency Medium/Format Submit To Applicable to Deliverable #4:

Maintaining ATO

Within 30 days of completion of each site installation and complete inventory at the completion of project.

Contractor’s discretion

COR and Site POC

MECs Additional required Information #54

Deliverable #5:

vulnerability and SCAP scan

10th day of each month. As required for RMF Certification and Accreditation to achieve ATO

COR and

DHA

Cyber POC

MECs Additional required Information #63

Deliverable #6:

Artifacts and Documentation required for RMF Certification and Accreditation

As required for RMF Certification and Accreditation to achieve

ATO.

As required for RMF Certification and Accreditation to achieve ATO

COR and

DHA

Cyber POC

MECs Additional required Information #64.