36C24126Q0257_2.docx

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

SET-ASIDE

VAMC Bedford

200 Springs Road Bedford MA 01730

POINT OF CONTACT*

Contracting Officer Manases Cabrera manases.cabrera@va.gov

PLACE OF PERFORMANCE

1400 VFW Parkway

West Roxbury MA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.201-1, “Simplified procedures,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01 of 3/13/2026.

The associated North American Industrial Classification System (NAICS) code for this procurement is 532490, with a small business size standard of $40 Million. The FSC/PSC is W065.

This is an unrestricted solicitation.

The VA Boston Healthcare System is seeking to lease the Stryker Q Guidance System Brand Name or Equal.

Salient Characteristics:

Image‑Guided Surgical Navigation System (Cranial & Spine) General The offered Image‑Guided Surgical Navigation System shall be new, commercially available, and FDA‑cleared for use in both cranial and spine surgical navigation. The system must meet or exceed the following minimum salient characteristics. Any product that fails to meet all salient characteristics will be considered non‑responsive and ineligible for award.

Clinical Application Requirements

1. The system shall support image‑based surgical planning and intraoperative navigation for both cranial and spine neurosurgical procedures.

2. The system shall provide real‑time 3D instrument tracking with accuracy suitable for complex neurosurgical workflows.

3. The system shall support standard clinical imaging inputs including, at minimum, CT and MRI, and be capable of performing registration and intraoperative guidance using those images.

Software Capabilities

4. The system shall include cranial navigation capability enabling:

• Anatomical landmark registration

• Image fusion

• Trajectory planning

• Real‑time cranial navigation

5. The system shall include spine navigation capability enabling:

• Vertebral level identification

• Registration appropriate for spinal anatomy

• Instrumentation guidance (e.g., pedicle screw trajectory guidance)

• Real‑time spinal navigation

6. The navigation software shall display 3D and multiplanar reconstructed (MPR) views, adjustable overlays, and surgical visualization tools required for neurosurgical procedures.

Hardware Platform Requirements

7. The system shall be mounted on a mobile, OR‑compatible cart or tower designed for sterile surgical environments.

8. The system shall include at least one surgical‑grade display with sufficient brightness and resolution for intraoperative visibility under OR lighting.

9. The system shall employ optical, electromagnetic, or equivalent tracking technology capable of achieving neurosurgical‑grade accuracy for cranial and spine procedures.

10. The system shall include all required components for full functionality, including but not limited to:

• Tracking cameras/sensors

• Reference frames

• Instrument trackers

• Sterile adapters

• Necessary mounts, cables, and accessories System Completeness and Integration

11. The system shall be delivered turnkey, fully installed, configured, and validated for clinical use.

12. The system shall integrate effectively into existing operating room workflows without requiring major OR reconfiguration.

Training and Documentation

13. The contractor shall provide on‑site clinical training for surgeons and perioperative staff to ensure operational proficiency.

14. The contractor shall provide complete user manuals, IFUs, training guides, and system configuration documents.

Regulatory and Safety Requirements

15. The system shall have current FDA clearance for both cranial and spine navigation applications at the time of offer.

16. All electrical, mechanical, and software components shall comply with applicable VA, Joint Commission, NFPA, and OSHA safety standards and requirements.

Warranty and Technical Support

17. The system shall include a manufacturer‑supported warranty, covering hardware, software, service, and technical support.

18. The contractor shall provide a preventive maintenance (PM) schedule and meet all manufacturer‑recommended service intervals.

Security, Privacy, and Records Compliance

19. Contractor personnel entering VA spaces shall comply with all badging, escorting, and mandatory training requirements.

20. If the system involves access to VA networks, systems, or sensitive information, the contractor shall comply with VA Handbook 6500, VA Handbook 6500.6, and all Privacy Officer (PO), Information System Security Officer (ISSO), and Records Officer (RO) requirements.

21. The contractor shall provide any required cybersecurity documentation, including but not limited to CSCA or other artifacts required for Government Risk and Compliance (GRC) processes.

All interested companies shall provide quotations for the following:

Supplies/Services

Stryker Q Guidance Equipment Lease Contract Period: Base POP Begin: 05-01-2026 POP End: 04-30-2027 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary

MANUFACTURER PART NUMBER (MPN): EQUIPMENT LEASE

Stryker Q Guidance Equipment Lease Contract Period: Option 1 POP Begin: 05-01-2027 POP End: 04-30-2028 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

Stryker Q Guidance Equipment Lease Contract Period: Option 2 POP Begin: 05-01-2028 POP End: 04-30-2029 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

Stryker Q Guidance Equipment Lease Contract Period: Option 3 POP Begin: 05-01-2029 POP End: 04-30-2030 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

Stryker Q Guidance Equipment Lease Contract Period: Option 4 POP Begin: 05-01-2030 POP End: 04-30-2031 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

Delivery shall be provided no later than 5/1/2026.

Place of Performance/Place of Delivery

WEST ROXBURY VAMC

1400 VFW PARKWAY

WEST ROXBURY, MA 02132

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

52.212-1 Instructions to Offerors—Commercial Products and Commercial Services.

System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations and certifications based on provisions that are not included in this solicitation. Examples include 52.240-90 Security Prohibitions and Exclusions Representations and Certifications, 52.242-91 Security Prohibitions and Exclusions, 52.240-92 Security Requirements, and 52.240-93 Basic Safeguarding of Covered Contractor Information Systems. Contracting officers will rely on representations from offers based on provisions in the solicitation. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023) Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR.

The following provision is incorporated into 52.212-1 as an addendum to this solicitation:

52.212-1 Instructions to Offerors—Commercial Products and Commercial Services

(a) Submission of Quotes. Submit signed and dated quotes to the office specified in this Request for Quote (RFQ) at or before the exact time specified in this solicitation. Quotes may be submitted on letterhead stationery, or as otherwise specified in the solicitation. As a minimum, quotes must show—

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of quotations;

(3) The name, address, and telephone number of the quoter;

(4) A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) Acknowledgment of Quotation Amendments;

(9) Quotes should include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotes that fail to furnish required representations, or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(b) Period for acceptance of Quotes. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of quotes, unless another time period is specified in an addendum to the solicitation.

(c) Late submissions, modifications, revisions, and withdrawals of quotes.

(1) Quoters are responsible for submitting quotes, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that quotes or revisions are due.

(2) Any quote received at the Government office designated in the solicitation after the exact time specified for receipt of quotes is "late" and may not be considered unless it is received before purchase order issuance and the Contracting Officer determines that accepting the late quote would not unduly delay the acquisition.

(3) If an emergency or unanticipated event interrupts normal Government processes so that quotes cannot be received at the Government office designated for receipt of quotes by the exact time specified in the Request for Quote, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of quotes will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(e) Debriefings. If a postaward debriefing is given to requesting Offerors, the Government will disclose the following information, if applicable:

(1) The agency’s evaluation of the significant weak or deficient factors in the debriefed Offeror’s offer.

(2) The overall evaluated cost or price and technical rating of the successful Offeror and the debriefed Offeror and past performance information on the debriefed Offeror.

(3) The overall ranking of all Offerors when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award.

(5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful Offeror.

(6) Reasonable responses to relevant questions posed by the debriefed Offeror as to whether the agency followed source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities at www.sam.gov for unique entity identifier establishment directly to obtain one. The Quoter should indicate that it is an planning to submit a quote for a Government Request.

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/ (End of Provision)

(End of Addendum to 52.212-1) (End of provision)

52.212-2 Evaluation—Commercial Products and Commercial Services.

ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

(a) Basis for Award. The Government will award a purchase order to the responsible quoter whose quotation conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

(b) The following factors shall be used to evaluate quotations:

(1) Technical or Quality

(2) Past Performance

(3) Veterans Involvement

(4) Price

(c) Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process, where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation, but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. The evaluation will consider the following:

(1) Technical or Quality: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government’s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation.

(2) Past Performance: The past performance evaluation will assess the relative risks associated with a quoter’s likelihood of success in fulfilling the solicitation’s requirements as indicated by the quoter’s record of past performance. The past performance evaluation may be based on the contracting officer’s knowledge of and previous experience with the supply or service being acquired; Customer surveys, and past performance questionnaire replies; Contractor Performance Assessment Reporting System (CPARS) at http://www.cpars.gov/; or any other reasonable basis.

(3) Veterans Involvement: In accordance with Veterans Affairs Acquisition Regulation (VAAR) 852.215-70 (DEVIATION), Service-Disabled Veteran-Owned and Veteran-Owned Small Business (VOSB) Evaluation Factors, the Government will assign evaluation credit for a Quoter (i.e., prime contractor) that is a Service-Disabled Veteran-Owned Small Business (SDVOSB) or a VOSB. To receive credit, an offeror must be registered and verified with the SBA at the time of both quotation submission and the time of award and must meet federal small business size standards for the North American Industry Classification System (NAICS) code assigned to this solicitation. Non-SDVOSB/VOSB quotations that use SDVOSBs or VOSBs as subcontractors will receive some consideration under this evaluation Factor. Quoters must state in their quotations the names of the SDVOSBs and VOSBs with whom they intend to subcontract and provide a brief description of the proposed subcontracts and the approximate dollar values of the proposed subcontracts. In addition, the proposed subcontractors must be registered and verified in the SBA Small Business Search and meet federal small business size standards for the NAICS code assigned to this solicitation at the time of both quotation submission and award.

(4) Price: The Government will evaluate the price by adding the total of all line item prices, including all options. The Total Evaluated Price will be that sum.

(d) Options. The Government will evaluate quotations for award purposes by adding the total price for all options to the total price for the basic requirement.

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Products and Commercial Services” [NOV 2025]

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.2 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

(End of Clause)

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

(End of Addendum to 52.212-4)

All responses shall be sent to the Contracting POC Manasés Cabrera at manases.cabrera@va.gov.

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Submission of your response shall be received not later than 4/3/2026 at 4:30 PM via email.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

Point of Contact Contracting POC Manasés Cabrera at manases.cabrera@va.gov

Combined Synopsis/Solicitation Notice