36C10G25R0024.docx

SUBJECT*

36C10G25R0024 | NX EQ Ultrasound Guided Fusion Biopsy System

GENERAL INFORMATION

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contract Specialist Alex Beck Alex.Beck1@va.gov

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

DESCRIPTION

Solicitation Number:

36C10G25R0024 Notice Type:

Combined Synopsis/Solicitation Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for brand name or equal commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “-Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

Solicitation number 36C10G25R0024 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Proposal (RFP). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-03, dated 17 January 2025.

Requirement Description:

The Veterans Health Administration (VHA) Equipment Life Cycle Management (ELCM) Program has identified Philips® or Equal Ultrasound Guided Fusion Biopsy System as a candidate for the Department of Veterans Affairs VA-wide (otherwise referred to as “national”) Non- Expendable Equipment (NX) contract award to deliver patient care at its VA Medical Centers around the country.

The Ultrasound Guided Fusion Biopsy System is an Image-guided computer-aided stereotactic surgical system designed to aid in the performance of minimally invasive biopsy procedures by combining medical imaging, dedicated computer software, and surgical instrument tracking systems for guidance. The systems provide surgeons with real-time, three-dimensional (3D) positioning and orientation of surgical instruments relative to the patient’s anatomy on a video display during the biopsy without the use of an endoscope. Biopsy-image guided stereotactic systems provide medical images that show the location of the instruments in real time during the biopsy. One or more imaging modalities, such as computed tomography (CT) and/or magnetic resonance imaging (MRI), may be used in the procedure.

A single award Requirements Contract will be awarded IAW FAR 52.211-6 Brand Name or Equal, accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Proposals shall contain the terms for cost/price and technical capabilities of the brand name or equal equipment. The Government reserves the right to award without discussions.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing Product Service Code: 6525 – Imaging Equipment and Supplies: Medical, Dental, Veterinary. This procurement action is issued as a Service-Disabled Veteran Owned Small Business (SDVOSB) set-aside.

This acquisition is for FAR Part 16.5 for Philips® Brand Name or equal Ultrasound Guided Fusion Biopsy System as identified in ATTACHMENT A – PRICE COST SCHEDULE - NX EQ Ultrasound Guided Fusion Biopsy System. All interested Offerors shall provide a proposal for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A – PRICE COST SCHEDULE – NX EQ Ultrasound Guided Fusion Biopsy System.

The ordering period is for one 12-month base year with four 12-month option years. Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

Distributors must be authorized distributors/resellers as certified by the OEM (i.e., in OEM letter with a current date and duly signed by OEM’s authorized representative) to be eligible for award. The OEM letter must be valid for the life of the contract. Those proposals which fail to meet the requirements of the solicitation and all the minimum salient characteristics will be rated “Unacceptable” and will be ineligible for award.

The FAR provision at 52.212-1, Instructions to Offerors – Commercial, applies to this acquisition including attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition.

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer.

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached.

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached.

All interested offerors must be registered in the System for Award Management (SAM) prior to submitting an offer. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 11:59 PM EST on June 23, 2025, to Contract Specialist, Alex Beck at Alex.Beck1@va.gov and Contracting Officer, Kimberly Lemieux at Kimberly.Lemieux@va.gov. No calls will be accepted.

Proposals are due via email by 11:59 PM EST on June 30, 2025, to Contract Specialist, Alex Beck at Alex.Beck1@va.gov and Contracting Officer, Kimberly Lemieux at Kimberly.Lemieux@va.gov.

Combined Synopsis/Solicitation Notice

Page 1 of

1. SCOPE OF WORK

The Veterans Health Administration (VHA) Non-Expendable Equipment (NX) National Program has identified the Ultrasound Guided Fusion Biopsy System product line as a candidate for a VA-wide (otherwise referred to as "national") single Requirements contract award.

The Ultrasound Guided Fusion Biopsy System is an Image-guided computer-aided stereotactic surgical system designed to aid in the performance of minimally invasive biopsy procedures by combining medical imaging, dedicated computer software, and surgical instrument tracking systems for guidance. The systems provide surgeons with real-time, three-dimensional (3D) positioning and orientation of surgical instruments relative to the patient’s anatomy on a video display during the biopsy without the use of an endoscope. Biopsy-image guided stereotactic systems provide medical images that show the location of the instruments in real time during the biopsy. One or more imaging modalities, such as computed tomography (CT) and/or magnetic resonance imaging (MRI), may be used in the procedure.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Ultrasound Guided Fusion Biopsy System to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four 12-month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires the offeror indicate that each product being offered as an “equal” product to the Philips® Ultrasound Guided Fusion Biopsy System. For each product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The offeror must also clearly identify the item by brand name (if any) and make/model number. Finally, the offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

The following line items comprise the Ultrasound Guided Fusion Biopsy System product line:

- parts and factory repair labor cost for defective systems

- transport cost for receiving systems back after repair (one leg of freight cost)

- next day delivery for smart set of field replaceable parts, including related transport cost

- immediate access to remote applications & tech support (standard office hours)

- on-site technical support (time, material and travel cost)

- 1 time period of 2 days per year on-site application training (not valid for SensaVue)

- System tune-up service up to 2 times / year, on customer request

- free updates for DMS Software, which comprises enhancement of existing feature packages

- 25% discount on upgrades for DMS Software with new feature packages

- parts and factory repair labor cost for defective systems

- transport cost for receiving systems back after repair (one leg of freight cost)

- next day delivery for smart set of field replaceable parts, including related transport cost

- immediate access to remote applications & tech support (standard office hours)

- 1 time period of 1 day per year on-site application training (not valid for SensaVue)

- free updates for DMS Software, which includes enhancement of existing feature packages

- parts and factory repair labor cost for defective systems

- transport cost for receiving systems back after repair (one leg of freight cost)

- next day delivery for smart set of field replaceable parts, including related transport cost

- immediate access to remote applications & tech support (standard office hours)

- 1 time period of 1 day per year on-site application training (not valid for SensaVue)

- free updates for DMS Software, which includes enhancement of existing feature packages

Contract Type: Low (1-4 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades available for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

Contract Type: Medium (5-10 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades available for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

Contract Type: High (11-25 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades available for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

Contract Type: Low (1-4 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades available for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

Contract Type: Medium (5-10 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades available for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

Contract Type: High (11-25 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades available for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

Contract Type: Low (1-4 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades available for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

Contract Type: Medium (5-10 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades available for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

Contract Type: High (11-25 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades available for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

The Department of Veterans Affairs (VA) is seeking vendors who can provide Phillips ® or equal Ultrasound Guided Fusion Biopsy System identified above which meet all the Salient Characteristics (SC's) listed below. The Government intends for offerors to include all ancillary items, to ensure the equipment can function as designed by the OEM and as clinically required. Products offered in the technical volume must be captured on the Vendor’s pricing volume (Attachment A - Price Cost Schedule) of the solicitation.

Additionally, responses can include any additional product and other product-related services necessary to obtain the supplies as required that may be beneficial and essential to the functionality of the proposed solution. These items must be clearly identified by brand name and part number.

When offerors include their additional proposed product items/services, these items may be considered for evaluation, and must be captured in the vendor’s pricing volume with an estimated quantity of zero.

CLIN’s 0001-0003, 0038-0041 apply to the following SC’s

Literature Review

Literature Review

MAINTENANCE, REPAIRS AND REPLACEMENT

Preventative Maintenance will be performed as prescribed by the manufacturer’s specifications. Maintenance, repairs, and replacement will be performed by authorized technicians and will be coordinated through the designated facility POC and Biomedical Engineer.

PRODUCT REFRESH

Product refresh is when a current CLIN is no longer being manufactured due to obsolescence and the product item is being replaced with a newer, and more often, a superior version of the same item. The current CLIN product will be revised to reflect the refreshed product information, manufacturer’s part number, IDC price (inclusive of Service Level Agreement (SLA) fee), etc.

The Government reserves the right to not accept the products offered under product refresh. The contractor will be notified in writing if a product refresh is not accepted. All products offered shall be provided with the warranty that is agreed upon for this contract.

The contractor agrees to ensure that all upgraded improved/replaced products meet American with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA) Federal requirements.

The contractor shall provide the COR and CO the following information for product refresh:

(1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule (to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA fee));

(2) Product literature for the item(s) refreshed.

(3) A detailed description of the differences or benefits of refreshed as compared to the item(s) being discontinued or added.

(4) Proper identification of any product requirements and/or procedures related to those product(s) proposed to be refreshed or upgraded.

(5) FDA approval, if applicable

(6) Provide historical sales to VA by item(s), if applicable

(7) Copy of Commercial Warranty.

The request shall be submitted to the COR, copy to the Contract Specialist and Contract Officer, for review and recommendation of approval to be submitted to the CO. The CO shall prepare a bilateral modification for execution.

PRODUCT REMOVAL OR RECALL

For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer shall resolve any defects or potential dangers by repairing or replacing the product at no cost to the government. The manufacturer agrees to take following steps immediately:

Notify the Contracting Officer (CO) at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

Provide copies of the notification to CO, Contracting Specialist, Contracting Officer Representative, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from customers and the contract number assigned as a result of an issuance on the solicitation;

(2) Reasons for modifications, removal or recall; and

(3) Necessary instructions for return for credit, replacement or corrective action.

A copy of the notification will be provided to: Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this combined synopsis/solicitation.

See attached document: ATTACHMENT A - Price Cost Schedule -NX EQ Ultrasound Guided Fusion Biopsy System See attached document: ATTACHMENT B - Contract Administration - NX EQ Ultrasound Guided Fusion Biopsy System See attached document: ATTACHMENT C - Contract Clauses - NX EQ Ultrasound Guided Fusion Biopsy System See attached document: ATTACHMENT D - Solicitation Provisions - NX EQ Ultrasound Guided Fusion Biopsy System See attached document: ATTACHMENT E - Reporting Tool - NX EQ Ultrasound Guided Fusion Biopsy System See attached document: ATTACHMENT F - Past Performance Questionnaire - NX EQ Ultrasound Guided Fusion Biopsy System See attached document: ATTACHMENT G - Past Performance Reference - NX EQ Ultrasound Guided Fusion Biopsy System