P02. - Streamlined MR Report Terumo Cardiovascular System_Co Signed.pdf

VHA Streamlined Market Research and Acquisition Planning Report

VHAPG Part 810.001 Market Research Page 1 of 5 Revision: 07 Effective Date: 04/01/2026 Acquisition ID: 36C262-27-AP-1432

Requirement Title: Terumo Cardiovascular System PMI 2237: 691-27-1-208-0020

In accordance with FAR 7.102, contracting officers and acquisition planners are required to perform acquisition planning and conduct market research. The following information is a summary of the acquisition planning: In submitting this request for procurement, the customer considered available sources within the agency, any government-furnished information/property, and security considerations IAW VA Handbook 6500.6. The contract type for this procurement is (FFP) and the milestone schedule will be accomplished and documented in the Electronic Contract Management System (eCMS). The information below summarizes the market research results for this requirement.

1. Objective: Per FAR 10.001(a)(2), VAAR 810.001-70, and VAAM M810.002-70 this report is in support of (check as many as apply):

A new requirement

An acquisition with an estimated value in excess of the simplified acquisition threshold (see FAR subpart 2.1 for current threshold) (Utilize Attachment 2: Market Research Report Template if action is over the $9 million)

An acquisition with an estimated value less than the simplified acquisition threshold where adequate information is not available to develop the requirements package and the circumstances justify the cost of performing the market research. If so, explain

An acquisition that could lead to a bundled contract (15 U.S.C.

644(e)(2)(A)) (see FAR subpart 2.1 for bundled contract definition);

Other: IAW RFO: 12.102, Restricting competition.

2. Background:

a. Description of service/supplies being requested: Preventive Maintenance Inspection (PMI) Terumo Cardiovascular Heart Lung Bypass System.

b. Product or Service Code: J065 - Maint/repair/rebuild Of Equipment- Medical, Dental, and Veterinary Equipment and Supplies.

c. NAICS Code: 811210 - Electronic and Precision Equipment Repair and Maintenance.

VHAPG Part 810.001 Market Research Page 2 of 5 Revision: 07 Effective Date: 04/01/2026 Acquisition ID: 36C262-27-AP-1432

d. Size Standard for NAICS: $34 Million.

e. Estimated contract value (to include any option years): $124,740.00.

3. Market Research Methods/Techniques/Sources: In accordance with FAR Part 10, VAAR 810, and VAAM M810 market research has been conducted for this acquisition. The following techniques were used and the timeframes/date of the research (check as many as apply):

Used Veteran Small Business Certification (VetCert) database to identify certified capable SDVOSBs and VOSBs. Utilizing NAICS Code 811210, it was found that there are 39 SDVOSB’s/VOSB’s.

Applying personal knowledge in procuring supplies/services of this type.

Contacting knowledgeable individuals in Government and industry regarding market capabilities to meet requirements. Contact Jan Przybylowicz, Biomed engineering to discuss details of requirement. Also spoke with Max Conroy to discuss proprietary rights and why Terumo has the rights.

Reviewing the results of recent market research undertaken to meet similar or identical requirements. Review current contract 36C26222C0016 market research documents to identify possible alternatives. None were found as Terumo is the OEM of the equipment.

Publishing formal requests for information in appropriate technical or scientific journals or business publications. N/A

Querying the Government-wide database of contracts and other procurement instruments intended for use by multiple agencies available at www.contractdirectory.gov and other Government and commercial databases that provide information relevant to agency acquisitions. FPDS, VetCert, and SAM.gov.

Participating in interactive, on-line communication among industry, acquisition personnel, and customers. N/A

Obtaining source lists of similar items from other contracting activities or agencies, trade associations or other sources. N/A

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Reviewing catalogs and other generally available product literature published by manufacturers, distributors, and dealers or available on-line N/A

Conducting interchange meetings or holding pre-solicitation conferences to involve potential offerors early in the acquisition process. N/A

Conducting market survey: N/A

Other: Terumo Cardiovascular System Corporation is the Original Equipment Manufacturer (OEM) of the Cardiovascular Heart Lung Bypass System and holds the proprietary rights to all equipment, parts, and licensing

4. Nonmanufacturer Rule (NMR) Findings (if the acquisition is for manufactured products or other supplies). Nonmanufacturer means a concern, including a supplier, that provides an end item it did not manufacture, process, or produce.

(See the Nonmanufacturer Rule Decision Tree to assist with this determination):

Does not apply.

5. Limitations on Subcontracting (LOS): The purpose of the LOS rule is to ensure small businesses do not serve as "pass-throughs" for large entities. LOS is applicable for all contracts awarded on a set-aside or sole source basis under the Veterans First Contracting Program (VFCP) and requires that VA ensure subcontracts are awarded to SDVOSBs/VOSBs. The rule places limits on the amount that can be subcontracted (e.g., 50 percent for services; reference FAR 52.219-14), ensuring that the small business has to perform some amount of meaningful work, so they don’t simply serve as pass-throughs. See the list of services/construction projects that are considered VA LOS High-Risk Areas of Concern and state any concerns to consider with this procurement if any: LOS does not apply.

6. Market Research Findings: Terumo Cardiovascular System Corporation is the Original Equipment Manufacturer (OEM) of the Terumo Cardiovascular Heart Lung Bypass System and holds the proprietary rights to all equipment, parts, and licensing. The PMI component parts are supplied and licensed by Terumo Cardiovascular System Corporation. Any maintenance and repairs must be handled by Terumo Cardiovascular System Corporation since a third-party vendor would not be able to perform on this equipment as it is proprietary and restricted, and nor does Terumo Cardiovascular System Corporation provide 3rd party vendor authorization to service, repair, maintenance equipment. Terumo Cardiovascular System Corporation is the only vendor that can maintenance and provide the maintenance and hardware for this equipment. Due to the unique characteristics of this requirement, it is concluded that only Terumo Cardiovascular

VHAPG Part 810.001 Market Research Page 4 of 5 Revision: 07 Effective Date: 04/01/2026 Acquisition ID: 36C262-27-AP-1432

System Corporation can provide these services and recommend this requirement to be sole sourced.

7. Customary Commercial Practices/Standards: N/A

8. Market Price: N/A

9. Acquisition History: 36C26222C0019 PoP: 11/10/2021 – 11/09/2026 Total amount $158,208.00 to Terumo Cardiovascular System Corporation.

10. Buy American Statute: The Buy American law restricts the purchase of supplies, that are not domestic end products, for use within the United States. Provide the following information on requests for supplies/products: Does not apply.

11. Other pertinent information (e.g., certifications/licenses required to perform the work): Must be Terumo Cardiovascular certified and licensed.

The following sources, to include size and socioeconomic status (suggest a minimum of two for open market requirements and three for FSS requirements) appear qualified and interested to fulfill this requirement:

Firm 1: Terumo Cardiovascular

6200 Jackson Road Ann Arbor, MI 48103

PREPARED BY: Contract Specialist

NAME: Marco Ramos

LOCATION: NCO 22, Services Branch 3

DATE: 10/20/2026

12. Contracting Officer Responsibilities:

a. Based on the above information, the basic clauses and provisions prescribed in FAR Part 12:

Are sufficient for use in this acquisition and do not require any tailoring to be consistent with industry's commercial practices.

VHAPG Part 810.001 Market Research Page 5 of 5 Revision: 07 Effective Date: 04/01/2026 Acquisition ID: 36C262-27-AP-1432

Require tailoring to be consistent with industry's commercial practices as noted below. All such tailoring will be included in the solicitation issued for the required supplies/services.

- Identify affected clause/provision paragraph and your recommended change(s); and

The item/service requested is non-commercial.

b. Recommendations: Based on the above information, it is recommended that the Federal Government award this procurement to Terumo Cardiovascular System Corporation as a sole source as they have the proprietary rights and IAW: RFO 12. 102, Restricting competition.

Name: _______________________________ Marco Ramos

Contract Specialist

Name: _______________________________

David Odne Contracting Officer Signature