36C24126Q0436.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

VAMC Bedford

200 Springs Road Bedford MA 01730

POINT OF CONTACT*

Contracting Specialist Julie Lemire julie.lemire1@va.gov

PLACE OF PERFORMANCE

West Roxbury VA Medical Center

- Neurology Department

1400 VFW Parkway

West Roxbury MA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Boston VAMC - Neurology Department is seeking a ROSA ONE Brain.

THIS IS A SOURCES SOUGHT NOTICE ONLY FOR Boston VAMC: This announcement is seeking information from the industry, which will be used for preliminary planning purposes for a single procurement. No proposals are being requested or accepted with this synopsis. THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT SHALL BE AWARDED FROM THIS SYNOPSIS. THIS IS STRICTLY MARKET RESEARCH.

The purpose of this synopsis is to gain knowledge of interest, capabilities, and qualifications of various members of industry, who have the capability and are authorized to as a manufacturer and or distributor for Brand Name Only supplies/services that are either domestic or non-domestic, this is for a firm-fixed-price contract.

The intent of this Sources Sought is to identify vendors in the open market who can fulfill the requirements as stated in the Performance Work Statement (PWS) included below. All items for the resulting contract shall be furnished by the selected vendor in accordance with the PWS. This notice is being published to conduct market research to determine if there are a sufficient number of vendors in the open market who can supply this order in aggregate, while affording competition to the fullest extent possible.

This request is new and for a short duration. The turn time will be short to meet the need.

All interested firms must be registered in SAM (System for Award Management) to be eligible for award of Government contracts. Interested parties responding to this Sources Sought request shall submit the following information at a minimum:

(1) Company name and address point of contact with phone number, and DUNS number.

(2) Documentation relating to capability of performance including the current point of contact and phone number.

(3) Socio-economic status to identify business class as being a large business, SDVOSB, VOSB, small business, Woman Owned, etc.

(4) Any other pertinent company documentation, prior to submission of offers to a solicitation.

Any SD/VOSB firms responding to this Sources Sought Notice must also provide proof of registration in the SBA Vet Cert, prior to submission of offers to a solicitation.

This market research is for informational and planning purposes. This is not a solicitation and does not obligate the Government to issue a solicitation. Please be advised the Government will not pay any costs for responses and information submitted. All submissions are acceptable via julie.lemire1@va.gov.

RESULTS INFORMATION: Respondents will not be notified of the results, and it is at the discretion of the Government to utilize results. Firms responding to this Sources Sought announcement, who fail to meet all requirements as stated above, and who fail to provide ALL of the required information requested, will not be used to help the Government make the acquisition decision, which is the intent of this sources sought announcement.

VHA Boston Healthcare System ROSA Robotic Assisted Neurosurgery Performance Work Statement

Privacy Statement:

Contractor shall adhere to all Veterans Affairs (VA) Privacy & Security, and Privacy Act and Health Insurance Portability and Accountability Act (HIPAA) requirements if exposed to protected health information (PHI) or when obtaining or reviewing information. This includes all log files, error traps, screen capture images and database query results used to aid staff with product troubleshooting or product support activities.

1.0 Introduction

VA Boston is actively developing its epilepsy surgery program, performing 49 procedures over the last 5 years. We have hired a functional neurosurgeon and are transitioning procedures performed in the community back to the VA, as well as receiving surgical referrals from throughout the Northeast region. However, VABHS requires a ROSA cranial system to support stereo-EEG, RNS, and DBS implantation. ROSA is the standard of care for advanced stereotactic functional neurosurgery procedures for epilepsy and movement disorders. The purchase order includes the navigation system, planning station, software, stereotactic frame, and necessary instrumentation. This equipment will significantly facilitate rapid access to epilepsy surgery and optimize efficiency and cost-savings within VABHS and for Veterans throughout the surrounding region, including minimizing wait times from multiple months to several weeks. As such, this is a critical resource for our program.

Advances in robotic-assisted neurosurgery offer the potential to significantly improve clinical outcomes, reduce operative times, and expand treatment capabilities for conditions previously considered inoperable or excessively invasive. The Department of Veterans Affairs has recognized robotic surgical systems as a priority investment to enhance surgical precision and expand minimally invasive treatment options for Veterans The objective of this procurement is to acquire a state-of-the-art robotic-assisted stereotactic neurosurgical system that will:

1. Enable precise, minimally invasive surgical interventions for movement disorders, epilepsy, brain tumors, and intracerebral hemorrhage

2. Reduce operative times compared to traditional frame-based approaches

3. Expand the Neurosurgery Department's capacity to treat complex cases

4. Integrate seamlessly with existing VA infrastructure, including PACS imaging systems, Mayfield head holders, and Leksell frames

5. Provide comprehensive training to VA surgical staff to ensure safe and effective system utilization

6. Establish a reliable service and maintenance framework to maximize system uptime and longevity

2.0 Scope

Provide and install the Zimmer Biomet ROSA Brain robotic platform to support minimally invasive stereotactic neurosurgery workflows (SEEG, DBS, biopsy, endoscopy) at VHA Boston, with pre‑operative planning, multimodal registration, rigid robotic guidance, and compatible instrumentation. The Contractor shall provide all labor, materials, equipment, software, and services necessary to deliver, install, calibrate, and support a complete ROSA ONE Brain robotic surgical system at the West Roxbury VA Medical Center. The scope includes all hardware components, software modules, accessories, instrumentation, training, documentation, and warranty services as detailed herein The addresses for the VA sites of care are as follows:

VA Boston Healthcare System West Roxbury VA Medical Center (Inpatient & Outpatient) 1400 VFW Parkway West Roxbury, MA 02132-4927 While the contractor is on site for installation, training, or any other reason, each contracted individual must have their VA PIV card displayed at all times. Contracted personnel without PIV credentials must be badged and escorted at all times by VA personnel. Upon arrival at the facility, all contracted personnel must check-in with their Biomed/HTM point of contact. The point of contact will be designated after contract award.

3.0 Performance Requirements

The Contractor shall perform to the standards defined below. Performance will be monitored by the Contracting Officer Representative (COR) or designated government personnel.

System Capabilities & Performance Requirements

· Robotic Dexterity & Precision Must support 6 degrees of freedom with rigid arm control, ensuring sub-millimeter placement accuracy (RMS < 0.75 mm) and repeatability ≤0.03 mm to enable precise, minimally invasive neurosurgical procedures.

· High Accuracy for Lead & Instrument Placement The system shall achieve mean radial error rates of ~0.7 mm for DBS lead placement, based on clinical literature (e.g., Lefranc et al., 0.81 mm; Neudorfer et al., 0.76 mm)

· Force-Torque Haptic Feedback Integration of force/torque sensors to establish a surgeon–robot “haptic interface”, supporting nuanced movements while maintaining trajectory integrity

· Multimodal Registration Capable of contactless laser registration via facial scanners, as well as traditional fiducials or frame-based registration; must allow pre-operative planning separate from OR imaging

· Software Planning Module Include intuitive pre-operative planning software, enabling 3D trajectory visualization and plan export. Must support deferred planning to optimize OR scheduling

Clinical Application Requirements ROSA Brain shall support and document successful completion of the following procedures:

· Stereo-Electroencephalography (SEEG)

· Deep Brain Stimulation (DBS) (awake/asleep workflows compatible with microdrives)

· Stereotactic Biopsy, Ventricular/Transnasal Endoscopy, Responsive Neurostimulation, etc.

Clinical staff shall receive training on each procedural module and workflow.

Tray & Consumable Instrumentation From quote (Boston VA ROSA Quote WRVA202602‑01) equipment must include:

· ROSA Cranial System (ROSAS00203)

· Titanium HeadRing Kit

· Additional instrument sets (part numbers: 809101, 803012, 803013, 803405) per scope of PWS

· Support for instrument tray sterilization/maintenance processes

Vendor responsibilities include delivery, installation, and initial training, DAP shipping terms included

· Delivery: All systems and kits delivered by DAP terms; ensure secure packaging, installation at customer OR suite.

· Installation & OP Validation: Vendor to conduct site survey, system calibration, accuracy testing, and registration protocol validation before first case.

· Training & Support: Provide comprehensive hands-on clinician & biomed training, including simulation, best-practice workflows, and troubleshooting. Ensure access to technical support.

· Documentation: Supply operator’s manuals, software guides, service contracts, and IFUs per FDA requirements Performance Acceptance: Verify system meets specification thresholds (accuracy, workflow time savings, patient comfort) through test data Documentation The contractor shall provide detailed documentation for all services performed, including installation, maintenance, and training. Documentation must be submitted to the COR for review and approval.

4.0 Deliverables

The Contractor shall provide the following items and services in accordance with the terms and conditions of this Scope of Work.

4.1 Major System Components

4.2 Surgical Instrumentation and Adaptors

4.3 Head Fixation and Fiducial Systems

4.4 Shipping and Delivery

4.5 Non-Clinical Deliverables (Documentation and Services)

Integration with Buyer’s Operations

· System Compatibility: Must integrate smoothly with existing head fixation systems (e.g., Leksell, CRW frames), microdrives, and intraoperative imaging modalities

· Platform Scalability: System shall support future dual-use for spine and cranial surgeries, allowing for modular growth and cross-specialty use.

· Patient Experience: Include features like non-shaving registration and contactless mapping to enhance patient comfort and reduce prep time Robotic arm with 6 degrees of freedom, designed for neurosurgery; rigid guidance once trajectory is set; force‑torque (haptic) sensing for co‑manipulation; no repositioning needed for bilateral cases.

· Accuracy and repeatability: platform literature indicates < 0.75 mm RMS absolute accuracy and 0.03 mm repeatability (design technical paper for ROSA platform).

· Pre‑operative planning station enabling advanced 3D trajectory mapping; contactless and traditional registration options (bone/skin fiducials; frame‑based).

Clinical Applications Supports SEEG (documented significant time savings vs. frame‑based), DBS (awake/asleep), biopsy, ventricular/transnasal endoscopy, and RNS workflows.

Integration & Compatibility

· Works with Leksell/CRW frames, common microdrives (FHC, Alpha Omega, Inomed), and intra‑op CT verification workflows.

· PACS connectivity and planning station per Zimmer Biomet documentation.

5.0 DELIVERABLE SUBMISSION AND ACCEPTANCE

5.1 Submission Instructions

· All deliverables shall be submitted to the Contracting Officer Representative (COR) electronically in Microsoft Office-compatible or PDF format unless otherwise specified.

· 5.2 Acceptance Criteria

· 5.3 Final Acceptance

· Final acceptance of the ROSA system is contingent upon successful completion of all performance requirements and delivery of all documentation. Payment shall not be processed until final acceptance is documented by the COR.

6.0 Applicable Directives

The contractor must comply with the rules and regulations of the Veterans Affairs Administration. All contractors accessing the equipment during installation and training must be certified (i.e. proper approval shall be obtained from the VA Information System Security Officer).

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employment. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract

All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.

7.0 RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VHA records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VHA contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VHA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material, and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy.

8. The Contractor shall not create or maintain any records containing any non-public VHA information that is not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VHA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

** VHA training for contractors is available in Talent Management System (TMS):

Records Management for Records Officers and Liaisons, Item #3873736

D. Flow down of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

END OF DOCUMENT