SSJ.pdf

Acquisition Plan Action ID: 36C241-24-AP-5817

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C241-24-AP-5817

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 1, located at Bedford, MA, in support of VISN 01, VA Health Care System at Boston Medical Center 2237 # 523- 25-1-7441-0006

2. Nature and/or Description of the Action Being Processed: This procurement is for a firm fixed price base plus four option years contract following FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The action being reviewed and approved will be awarded as a new contract to provide Original Equipment Manufacturer (OEM) certified technicians for preventive maintenance (PM), repairs, and support for Spectrum Medical, Inc., Quantum Perfusion Technologies (heart/lung bypass) machine No 20- 8208460 for use in the operating room VA West Roxbury Campus.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: BHS owns and has been using the Spectrum heart/lung bypass machine since 10/23/2023. The Quantum Perfusion System is a high-tech medical device that assumes the function of the heart and lungs during medical procedures. This requirement is for the Sentinel Product Support as follows:

Comprehensive 24/7 Support Spectrum Medical's innovative 24-hour live messaging support platform gives users immediate access to an extensive knowledge-based product library, frequently asked questions, and troubleshooting lips. Additionally, the platform supports immediate communication with Spectrum Medical's global support team, which comprises service technicians, clinical consultants, and system application experts, via a dedicated phone number, email address, or Spectrum Medical 24-hour live messaging service.

Quantum eLearning This includes access to Spectrum Medical's web-based electronic Learning Management System (or LMS), which streamlines product training and complements current training practices and recertification.

Annual Servicing Includes all required servicing visits performed by dedicated Spectrum Medical service personnel.

Replacement Parts Includes the cost of any replacement parts/repairs arising from a service.

Emergency Loan Equipment For all products that cannot be repaired within 24 hours of being returned to Spectrum Medical Service Center.

Extended Warranty

Total warranty on your Quantum Perfusion System including associated accessories (sensors, cable assemblies etc.). Quantum products beyond economic repair will be replaces with the latest new build technologies.

Time Expired Sterile Products Partnering with hospitals in the provisioning of care is at the core of the Sentinel relationship.

Quantum sterile products supplied by Spectrum Medical that have exceeded their expiration date can be returned to Spectrum Medical and exchange for new replacement producs free of charge.

Accidental Damage Accidental damage on your Quantum Perfusion System, including accessories (sensors, cables assemblies, third-party device connectivity-related equipment, etc.) Quantum products beyond economical repair will be replaced with the latest new build technologies.

Remote On-Line Support Integrated within the VISION Server System and with VPN access, the Sentinel maintenance application provides a capability to support the remote monitoring and fault diagnosis of all Quantum systems network connected to the local VISION server.

Software Updates During the service visit, Quantum Software will be maintained to the latest standards, including changes to user functionality, updates to enhance maintainability, reliability, and protocol changes to 3rd party device driver software at no cost to the customer. Software deployment is subject to prior customer approval and training via webinar or in-house at Spectrum Medical is included free of charge.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Spectrum Medical is the only responsible source. This is highly specialized equipment that assumes the function of the heart and lungs during medical organ transplants and other medical procedures.

The original equipment manufacturer must perform the services. Soliciting from other sources will cause risk and substantial duplication of cost to the government that is not expected to be recovered through competition.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An Intent to Sole Source notice was issued and posted to SAM.gov. No responses were received from the posting.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: A search on the FPDS Website revealed many contracts that can be used to compare proposed prices.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: The following market research sources were searched: SBA Vet Cert, FPDS, SAM.gov, GSA, and DSBS.

Due to the peculiar nature of this requirement, no capable SD/VOSB was found that could perform the required service. Spectrum confirmed via a sole source letter that it is the sole producer, vendor, supplier, and distributor of its products.

Due to regulatory compliance, Spectrum personnel shall perform services, including maintenance.

As the equipment is proprietary, no other organization is trained or authorized to service it.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Spectrum Medical 481 Munn Road, Suite 180 Fort Mill SC 29715 800-265-2331 www.spectrummedical.com

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required: None.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Dennis Allen Date

VISN1

Boston VA Healthcare System

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Ashley Zannikos Date Contracting Officer

NCO1

DENNIS

ALLEN

Digitally signed by

DENNIS ALLEN

Date: 2024.09.23 08:27:46 -04'00' 9/23/24

ASHLEY

ZANNIKOS

Digitally signed by

ASHLEY ZANNIKOS

Date: 2024.09.23 12:28:54 -04'00'

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Sheryl Anthony Date Branch Chief

NCO1

SHERYL ANTHONY

Digitally signed by

SHERYL ANTHONY

Date: 2024.09.24 13:30:50 -04'00'