36C25626Q0513 RFI.pdf

Sources Sought Notice

*= Required Field Sources Sought Notice

SUBJECT* Cryoablation System for Interventional Radiology

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25626Q0513

RESPONSE DATE/TIME/ZONE 03-23-2026 12:00 CENTRAL TIME, CHICAGO, USA

ARCHIVE 15 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* 6525

NAICS CODE* 339112

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16 5075 Westheimer Road, Suite 750

Houston TX 77056-5643

POINT OF CONTACT* Contract Specialist Eugene Jackson Eugene.Jackson2@va.gov

PLACE OF PERFORMANCE

ADDRESS Michael E. DeBakey VAMC

2002 Holcombe Blvd.

Houston TX

POSTAL CODE 77030

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov/ URL DESCRIPTION VA Home Page AGENCY CONTACT’S EMAIL ADDRESS eugene.jackson2@va.gov EMAIL DESCRIPTION POC Email Address

DESCRIPTION

1. Title: Cryoablation System for Interventional Radiology

2. Purpose: The Network Contracting Office (NCO) 16, located at Galleria Financial Center, 5075 Westheimer Rd, Ste 750, Houston, TX 77030, hereby issues the following Sources Sought to Request Information (RFI) with the intent of determining the contractor interest, capabilities, qualifications of potential businesses, nonmanufacturer rule compliance, Buy American Act compliance, Trade Agreement compliance and estimated industry pricing information for market research and estimated budgetary purpose to provide a Cryoablation System.

Contractors shall provide all necessary labor, materials, supplies, equipment, and transportation to provide and install additional systems. This Sources Sought is published for market research purposes. This Sources Sought will be used to determine if a set-aside for any small business program is appropriate. Government anticipates competitive, firm fixed price task order if on a Federal Supply Schedule (FSS) or firm fixed price purchase order if “open market”. Please review this announcement, respond to questions below and review all attachments in their entirety.

Government requests that interested offerors complete all questions below, provide required documentation, descriptive literature and/or authorization letter as described below. The Government is in no way obligated to do business with or to enter any form of contract with any person, firm or other entity that receives or responds to this announcement.

3. Objective: To find qualified contractors with the capability to provide a cryoablation system for the Michael E. Debakey VA Medical Center located in Houston, TX.

4. Place of Performance:

Michael E DeBakey VA Medical Center 2002 Holcombe Blvd Houston, TX 77030

5. Responses Requested: The NCO 16 requires all the following information and questions answered 5a through 5i (in the order and format provided) in this RFI/SS: Questions and information that are not provided shall be considered nonresponsive to the Request for Information and contractor shall not be considered as part of the market research.

a. Do you (contractor) possess the capability to meet the government requirements listed in section “C- General Requirements” Draft SOW?

b. Do you (contractor) possess the capability to meet the government requirements of place of performance of the Draft SOW?

c. Do you (contractor) possess the capability to meet the government requirements Period of Performance and Schedule in section “D – Period of Performance” of the Draft SOW?

d. Contractors shall provide their point(s) of contact name, address, telephone number, and email address; and the company's business size, and SAM Unique Entity Identification Number.

e. Is your company a small business, SDVOSB, VOSB, SDBs, HUBZone, or 8A concern? Please provide proof of qualifications.

f. Is your company considered small under the NAICS code 339112?

g. Do you (Contractor) have the ability to meet the requirements in SOW itself or will subcontracting be required for you to meet requirements in SOW?

h. Are you an authorized distributor/service provider? Provide evidence from original equipment manufacturer (OEM). *If interested vendor is the OEM, an authorization letter is not required* Please indicate in your response if you are the OEM.

i. For the supplies and/or services required, Is your company available under any;

Government Wide Agency Contract (GWAC) General Services Administration Schedules (GSA) Veterans Affairs (VA) NAC Federal Supply Schedules Indefinite Delivery Indefinite Quantity (IDIQ) Blanket Purchase Agreement (BPA)

If so, please list the contract number for service.

6. Opportunity: The NCO 16, is seeking information from potential contractors on their ability to provide this product/service. THIS IS A SOURCES SOUGHT FOR REQUEST INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this Sources Sought in order to assist the NCO 16 in determining potential levels of competition available in the industry. Contractors shall possess the capability to provide all requirements and objectives.

7. Instructions and Response Guidelines: Sources Sought responses are due by MAR 23, 2026, at 12:00 PM (CST) via email to eugene.jackson2@va.gov.

All questions shall be submitted by MAR 18, 2026, at 12:00 pm (CST) via email to eugene.jackson2@va.gov.

Telephone requests or inquiries will not be accepted.

Public Information will not be provided and shall be utilized to the full extent possible.

This is a new requirement.

The subject line shall read: 36C25626Q0513 - RFI-Sources Sought Cryoablation – Houston, TX.

NO SOLICITATION EXISTS AT THIS TIME. There is no page limitation on subparagraphs 5(a) - 5(i).

Please provide the information you deem relevant to respond to the specific inquiries of the Sources Sought. Information provided will be used solely by NCO 16 as "market research" and will not be released outside of the NCO 16 Purchasing and Contract Team.

This Sources Sought notice does not constitute a Request for Proposal (RFP), Invitation for Bid (IFB), or Request for Quotation (RFQ), and it is not to be construed as a commitment by the Government to enter into a contract, nor will the Government pay for the information submitted in response to this request. All information contained in this Sources Sought is preliminary as well as subject to modification and is in no way binding on the Government.

In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. If a solicitation is released, it will be synopsized on Contracting Opportunities (https://beta.sam.gov/) website or GSA e-buy. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this Sources Sought, or future RFP/RFQ.

8. Contact Information:

Contract Specialist, Eugene Jackson Email address: eugene.jackson2@va.gov Your responses to this notice are appreciated.

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES/PROPOSALS; however, any firm that believes it can meet the requirements may provide answers, responses and give written notification prior to the response due date and time. Supporting evidence and responses must be furnished in enough detail to demonstrate the ability to perform the requirements.

DRAFT Statement of Work

A. GENERAL GUIDANCE

1. Title: Cryoablation system at Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston, TX.

2. Scope of Work: Cryoablation is utilized in Interventional Radiology to support physicians performing percutaneous cryoablation under image guidance. The System will need to deliver controlled cryogenic temperatures through specialized cryoprobes to create an ablation zone (“ice ball”) within targeted tissue.

3. Delivery Location:

MEDVAMC

2002 Holcombe Blvd.

Houston, TX. 77030

Contractor will deliver the unit. System must be covered by original OEM warranty.

4. Background: The current cryoblation system is more than ten years old, has demonstrated declining reliability, utilized outdated technology, and is no longer covered under a service contract.

5. Type of Contract: FIRM FIXED PRICE

B. DEFINITIONS/ACRONYMS:

1. Biomedical Engineering - Supervisor or designee

2. CO - Contracting Officer.

3. Standard Service Agreement - Standard Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist any standard service package in accordance with the manufacturer’s latest established service procedures to ensure operation of equipment within manufacturer’s or VA’s performance specifications, whichever is the most rigorous. All equipment shall be operated at least one complete operating cycle at the end of each PM.

4. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Medical Center premises.

5. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

6. Acceptance Signature - VAPHI employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

7. Authorization Signature – Biomedical Engineering Staff signature; indicates Biomedical Engineering accepts work status as stated in ESR.

8. NFPA - National Fire Protection Association.

9. CDRH - Center for Devices and Radiological Health.

10. VAPHI - Department of Veterans Affairs Philadelphia Medical Center.

11. OEM - Original Equipment Manufacturer

12. CEU – Continuing Education Credit

C. GENERAL REQUIREMENTS

1. This agreement includes all components of the cryoablation system, consisting of a console, remote control keypad, and software.

a. Cryoablation System minimum requirements:

i. The equipment may be used for the following procedures including, but not limited to:

1. Renal tumor cryoablation

2. Liver tumor ablation

3. Bone metastasis pain palliation

4. Soft tissue lesion ablation

5. Other physician-directed cryoablation procedures consistent with

FDA indications and facility privileges

b. Standard Service agreement – Minimum but not limited to 1 year.

i. Contractor must provide standard service agreement package to include standard service package details in solicitation response.

ii. Hours of Coverage:

1. The contractor will provide all required services within the normal business hours (8:00 AM to 5:00 PM (CST) M-F).

2. Customer service shall respond to service request calls within the normal business hours (8:00 AM to 5:00 PM (CST) M-F).

c. Parts:

i. All parts supplied shall be OEM and fully compatible with existing equipment. No refurbished parts shall be used in the repairs of units covered in this contract. The contract shall include all parts with the exception of consumable or expendable items and specialty components.

Used parts, those removed from another system, shall not be installed without approval by Biomedical Engineering. The contractor is required to install VA supplied parts when said parts are determined to be fully compatible. The determination of compatibility is at the discretion of Biomedical Engineering Staff. All defective parts replaced become the property of the Contractor, unless otherwise specified by the CO or Biomedical Engineering.

d. Warranty:

i. System must be covered by original OEM warranty.

e. Customer Notification:

i. Contractor shall notify Biomedical Engineering and the Police service when they arrive on site. Contractor will schedule all preventative maintenance with Biomedical Engineering. All vendor mobile media devices (USB drives, CDs, DVDs, etc.) must be scanned by Biomed before use.

ii. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s) per Section E.

iii. The FSE shall be required to check out with the Biomedical Engineering Department and submit the ESR(s) to the designated personnel. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to Biomedical Engineering for an "authorization signature." A signed accepted copy of the ESR will be sent to Biomedical Engineering within five business days of work completion.

iv. FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH

EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE

DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT

AND MAY BE JUSTIFICATION FOR TERMINATION OF THE

CONTRACT.

D. PERIOD OF PERFORMANCE

The period of performance is delivery within thirty (30) days from contract award. The standard service agreement shall last for the duration of the OEM standard service package.

E. CONFORMANCE STANDARDS:

Contractor shall provide materials and standard services to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

F. DOCUMENTATION/REPORTS:

The documentation will include equipment downtime and detailed descriptions of the scheduled and unscheduled service procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards.

G. SCHEDULE FOR DELIVERABLES

Draft copies of deliverables shall be provided to Biomedical Engineering staff at MEDVAMC before the contractor leaves the facility at each visit. If a final copy can be provided at that time then a draft copy is not necessary, final copies must be provided within 5 business days of the time of each deliverable.

H. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

I. SERVICE MANUALS/TOOLS/EQUIPMENT

1. MEDVAMC shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation, (such as: operational and service manuals, schematics, and parts list), which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO and VA POC upon request.

2. Prior to commencement of work on this contract, the contractor shall make available if requested a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by MEDVAMC. Test equipment calibration shall be traceable to a national standard.

J. CONDITION OF EQUIPMENT:

The contractor accepts responsibility for the equipment described in this scope of work, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor of performance of the requirements of this contract.

K. CONTRACTOR EXPERIENCE REQUIREMENTS

1. Each respondent must have an established business, with an office and full-time staff.

The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

2. Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment system identified in this SOW.

3. The FSE(s) shall be authorized by the contractor and OEM to perform the standard services as required. All work shall be performed by "Fully Qualified" competent FSEs.

The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any MEDVAMC equipment.

The CO and/or Biomedical Engineering specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the MEDVAMC equipment.

4. If coming on-site, contractor personnel must provide a copy of: 1) Tuberculosis (Tb) vaccination documentation, 2) flu vaccination documentation and 3) copy of HIPAA compliance training certificate.

L. CONFIDENTIALITY AND NONDISCLOSURE:

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this supply order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the contract.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this contract. No information shall be released by the contractor. Any request for information relating to this contract, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

M. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA

REGULATIONS:

1. The contractor's FSE shall wear visible identification at all times while on the premises of MEDVAMC. Identification shall include, as a minimum, the employee’s name, position, and the contractor’s trade name.

2. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service.

MEDVAMC will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

3. Smoking is prohibited inside any buildings and on premise at MEDVAMC. This covers all smoking and tobacco products, including but not limited to:

a. Cigarettes

b. Cigars

c. Pipes

d. Any other combustion of tobacco

e. Electronic nicotine delivery systems (ENDS), including but not limited to electronic or e-cigarettes, vape pens, or e-cigars.

f. Chewing tobacco

4. Cellular phones and two-way radios are not to be used within six feet of any medical equipment.

5. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

N. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS:

1. Contractor may not have access to the VA network or any VA sensitive information under this contract.

2. Contractor owned computer equipment including laptops are not permitted to be connected to the VA network. Any removable storage device used in medical equipment must be scanned by Biomed or OIT.

3. The following language from VA Handbook 6500.6 is required in this contract:

a. Appendix B: All

b. Appendix C: Paragraphs 1, 2, 3, 5, 6, 7, 9

4. All Contractors must receive Privacy training annually using one of the following methods:

5. Complete “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information” training by using VA’s TMS system (https://www.tms.va.gov/). Contractors may use the TMS Managed Self

6. Enrollment method to complete the training in TMS. Biomedical Engineering Staff must ensure that all contractors are validated in the PIH domain.

7. Complete the hard copy version of “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information”. Signed training documents must be submitted to Biomedical Engineering.

(End of Draft Statement of Work)