Amendment-6 Attachment A - SOW Mammography.docx

Attachment A – Scope of Work Mammography

Scope of Work

A. Description of Equipment and Service:

The contractor shall provide delivery, setup, commissioning, supervision, labor, parts, materials, tools, supplies (with the exception of Government furnished supplies listed), and equipment necessary to provide a Mammography Unit with 2D and 3D Imaging, Upright Biopsy Unit, PACS Archive and Artificial Intelligence Software. The contractor shall obtain and maintain all required Federal, State, and Local licenses associated with the operation/transportation of the equipment and performance of the services being requested.

Mammography Unit and Archive:

Contractor to include all equipment, delivery, set-up, installation and commissioning of Mammography Unit and Archive for the Phoenix Indian Medical Center, (PIMC). The System shall be Food and Drug Administration (FDA) approved and be on the Vista Imaging Digital Imaging and Communications in Medicine (DICOM) Modality Interfaces list dated August 1-31, 2022 (Attachment C - Vista Imaging DICOM Modality Interfaces August 1-31, 2022). It must interface with Vista Imaging and Vista Radiology, which are supported by the Veteran’s Administration. These systems shall be utilized by Registered Radiologic Technologists and Radiologists. The contractor shall provide connectivity with Vista Rad and Vista Imaging, contractor provided archive and the digital radiographic system. The contractor shall demonstrative with the Contracting Officer and COR that the system has connectivity and is functioning.

System Minimum Requirements:

1. EQUIPMENT:

Mammography Unit, and Archive Manufacturer: Hologic Model: 3Dimensions with 2D Capability, Clarity HD with Intelligent 2D and 3D Quorum Smart Slice Technology, SmartCurve breast stabilization system.

3DM-SYS-STD – 3D mammography system w/ 2D capabilities PRD-04420 – 3D high res-ready digital image receptor 3DM-KIT-ERGOXRAY – Ergonomic features STLC 00004 Breast Biopsy guidance system.

ASY-09880 – Lateral arm upright biopsy accessory kit ASY-06484 – Tomo biopsy kit BREVADPTR – Biopsy system adaptor BI-FURN-0002 – Chair for biopsies ASY-04662 – Racks for paddle storage DIM-LIC-I2D3DQ – 2D and 3D Quorum licenses DIM-LIC-GDT-IC – AI detection and image checker software/licenses DIM-LIC-QT – Breast density assessment software/ licenses DIM-KIT-NLOC – Needle location kit SVC-SDM-OPT-BTO – Selenia Dimensions BTO enabled SXCH-SYS-6218-3DV – Archive 21.8 TB PACS w/ 3D view software SXCH-LIC-HL7 – HL7 license SXCH-DMS-PACS – Digital mammography data migration service SDM-TRAIN-INIT-05, SDM-TRAIN-INIT-02, DIM-TRAIN-APPSINIT, DIM- TRAIN-PHY-INIT, GDT-TRAIN-INIT-01, 3DQ-TRAIN-INIT-01, DIM- TRAIN-RAD-INIT, , SXCH-TRAIN-INIT-01 – Training for technologists, physicians, and physicist.

Salient Characteristics:

a. 3D (Tomosynthesis) Screening and Diagnostic Mammography System with 2D capability; and Biopsy Capability

b. HD High Resolution-enabled detector

c. X-ray tube: Tungsten, bi-angular, high speed, high heat capacity.

d. X-ray filters: Rhodium, silver, aluminum.

e. Dual function gantry foot switches

f. Acquisitions Workstation Software/Workstation w/ color display and X-ray shielding. High performance CPU with minimum 32 GB RAM and 4 TB disc, Windows 10/64.

g. Image View: 3 MP, medical-grade color, DICOM monitor with double-jointed articulating arm. Recommended large screen instead of two separate monitors.

h. Archive for images 20 TB at a minimum, 30 TB PACS preferred (if available)

i. Digital migration services of old archive to new archive system

j. HL7 license if needed; licenses for all purchased software.

k. CD/DVD read and write for image transfer

l. DICOM: Modality work list, storage, storage commitment, query/retrieve, print.

m. DICOM Modality Performed Procedure Step (MPPS)

n. DICOM Radiation Dose Structured Report (RDSR)

o. Ability to interface smoothly with 3rd party dose aggregation and reporting systems

p. Rack(s) for storage of all purchased paddles.

q. Paddles (3): Small 18 x 24 cm, large 24 x 29 cm, and Mini 18 x 4

r. Screening Paddles (3): Frameless, 24 x 29 cm, 18 x 24 cm, small breast

s. Diagnostic Paddles (5): Spot contact, spot contact 10 cm, spot contact 7.5 cm, 10 cm magnification, 7.5 cm spot magnification.,

t. Spot Contact Paddle (1): 7.5 cm for use during QC testing only.

u. American College of Radiology-approved phantoms- flat field and geometry calibration

v. Breast Biopsy guidance system with lateral approach capability. Training included.

w. Tomo biopsy capability

x. Breast biopsy chair

y. Needle localization capability including all accessories/adaptors

z. Artificial Intelligence Detection and Computer-Aided Detection (CAD) System and Licenses

aa. Breast Density assessment software for 2D and 3D and licenses.

ab. Breast stabilization system

In addition to the mammography unit, the following minimum is required:

a. DICOM – VA Vista Rad and Vista Imaging compatible;

b. Windows 10 or Unix;

c. Hard copy and digital copy, if available, of the original OEM System manuals, software CD/DVDs, schematic drawings, and any additional OEM documents for Mammography unit;

d. Attachment C - Vista Imaging DICOM Modality Interfaces August 1-31, 2022.

e. Contractor shall preinstall mammography protocols. Contractor may recommend new and updated protocols to PIMC. Contractor shall provide phone support for protocol issues, updates and troubleshooting.

f. Complete the Indian Health Service Network Interconnection Security Agreement (ISA) for remote access.

g. Contractor shall provide Remote Access.

h. Power Surge Protection and Uninterrupted Power Supply The contractor will provide and install Power Surge Protection and Uninterrupted Power Supply with each unit. The intent of the Power Surge Protection and Uninterrupted Power Supply is to protect the equipment from unintended damage to the equipment. Power surges may include lightning strikes, PIMC generator testing, city power electrical fluctuations, or any other cause of a power surge. Contractor will recommend the unit size needed and install the units.

i. Contractor to migrate images from Hologic Secure Exchange system to new contractor Archive PACS. This is under 15TB of images that will need to be migrated to the new contractor Archive PACS. The contractor will install the new PACS system within 15 days from award and migrate data to the new system. The existing system is displaying error codes from the Hologic Secure Exchange Dell server; however, it is still running and operational. This work is to be onsite by the contractor representative to migrate data and update all IP addresses with the system to the PIMC system (Dimensions unit, SecureView, Vista Imaging PACS, CAD and new contractor archive PACS. The new PACS system will serve as the primary PACS system with the PIMC Vista Imaging PACS as the backup disaster recovery system. Contractor to return to update IP addresses and connectivity when the remainder of the items under this contract is installed.

j. Contractor to include all FDA Cybersecurity compliance software patches for equipment.

k. Government will utilize government owned Mammotome Revolve unit procured in 2018.

*52.211-6 Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must-

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by-

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

2. DELIVERY/INSTALLATION

Contractor shall include installation to be performed by an OEM-certified service and installation engineer(s) to ensure a safe and functional installation.

A. Contractor to install new contractor archive PACS system within 15 days from award. Contractor to migrate all data from government owned Hologic Secure Exchange to the new contractor archive PACS system. This includes installation, updating IP addresses to the government owned Hologic Dimension unit, Secure View, CAD and other Hologic connected hardware and software. Contractor representative will be required to come back to install the remainder of the system when available.

B. Contractor shall provide equipment installation schedules to include all lead times and milestones;

C. Physicist inspection/testing following the installation to ensure that the “Mammography Unit” and all components meet Federal regulatory requirements; (Copy of report is to be provided to the COR and PIMC Biomedical Department.) Contractor to provide a copy of physicist credentials to include Mammography license, diploma, Mammography training CME, and resume to COR.

D. Installation shall include commissioning start up and all functions of the Mammography unit, 2D/3D software, A.I. and PACS Archive are working. Demonstrate to the Contracting Officer Representative and PIMC Information Technology Department that the Mammography unit, 2D/3D software, A.I. and PACS Archive are communicating with Vista Imaging and Vista Radiology.

E. Contractor shall transfer all FDA and ACR existing Quality Assurance and Quality Control data from the current Mammography system to a CD or printed on paper. This data shall be handed to the COR before the system is removed.

F. Contactor to provide all passwords to the Technologist Workstation, Radiologist Workstation, CAD servers, PACS servers, and other equipment/software provided.

3. EQUIPMENT REMOVAL (TRADE-IN)

Contractor shall remove the Hologic Selina Dimensions, CAD, SecureView and SecureXchange (except hard drives) and all required components and dispose of as required by Federal, State, and County regulations. Contractor shall include and credit the estimated salvage value of the system in the quote. Title of equipment/ownership shall become the property of the contractor. Contractor shall include and credit the estimated value of the existing system in the quote. Hard drives are to be removed by the Contractor and delivered to PIMC. Hard drives will not be part of the trade in and remain property of the Government. Hard drives are to remain on PIMC campus at all times.

If any walls, ceilings or floors are patched, they must be patched in a manner approved by OSHA for lead shielding.

Trade-In:

The government will be trading in the following units:

1. Hologic Selina Dimensions

2. Computer Aided Detection

3. SecureView (Radiologist Workstation)

4. SecureXchange (Archive)

Contractor will record all serial numbers for all equipment for 1, 2, 3 and 4. Contractor will provide a list of all serial numbers, make and model of all parts to the COR. Contractor will compete an HHS-22 Request For Property Action transferring property to contractor at time of removal.

4. TRAINING

The purpose of this section is to understand the supplemental vendor Training Program fees throughout and after this procurement. The training audience shall include Radiologic Technologists (Mammography), Radiologists, and supporting imaging staff within the institution. PIMC seeks the costs of onsite training that follows the initial equipment install, in addition to the supplemental training required during major equipment be considered include distance learning, Computer-Based Training, and/or web meetings.

Contractor training programs include the following minimum requirements:

B. Five (5) eight-hour days of onsite training on the Mammography unit and all components following integration to Radiology Information System Package (RPMS) and PACS and/or as needed for advanced follow-up training for) (2) two PACS Administrators, and Radiologists as pertinent:

a. As a minimum, Mammography unit training should include: DICOM (MDWL, Store, Query/Retrieve, and Print) functionality training, application training, any proprietary QA/QC testing in digital environment, and system administrative configuration procedures;

C. Training associated with proprietary Service Repair call systems, if applicable to include 4 PIMC Biomedical staff (onsite/remote/online/web training).

D. Six months (unlimited) Remote/Online/Web training as needed (on demand videos).

52.237-1 SITE VISIT

Licenses/Permits

The contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. He/she shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employees’ fault or negligence, and shall maintain personal liability and property damage insurance, having coverage for a limit as required by the laws of the State of Arizona. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, shall not be the responsibility of the contractor hereunder with regard to any claims, loss, damage, injury, and liability resulting there from.