P03 JA FAR 13.5 Quantum Heart Machine 36C241-23-AP-2070 Signed DR-GG.pdf

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C241-23-AP-2070

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 Healthcare System Medical Center 2237 # 405-23-2-7821-0047

2. Nature and/or Description of the Action Being Processed: This procurement is for a Quantum Heart Machine in accordance with 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 CPB system is a critical device that makes it possible for open heart surgery. It is designed to take over the job of a patient’s heart and lungs so that a surgeon can operate on a non-beating heart. Our current Heart & Lung machines are the LivaNova S5 and are 10 years old. To keep pace with current safe techniques and proper patient monitoring, it is vital that our heart and lung machines are up to date. Updating the heart and lung system to the same company makes for easy integration and eliminate multiple vendors for device maintenance.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: There are a few companies that can provide the heart and lung machine but because of concerns for smooth integration of the Quantum EMR system, it is crucial that we have both the software and hardware from the same company. There is no other vendor/source that can provide better interface to the Spectrum Quantum 15 Workstation.

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

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Quantum Heart Lung Machine is fully integrated with the Hospital Information System. This both improves patient safety by centralizing the perfusionists scan to one location during cardiopulmonary bypass meaning they are not looking at multiple monitors while taking over full cardiopulmonary support of the patient. It

Effective Date: 02/01/2022 Page 2 of 3 also reduces capital costs by integrating the Heart Lung Machine and charting system into a single system. We are currently using the Spectrum charting system which is at end of life at the same time that the heart lung machine is at end of life. By purchasing the charting system and heart lung machines in the same year it will reduce overall capital costs. Additionally, other VA systems have converted to the Spectrum charting system making integration between the hospital systems for quality improvement and benchmarking more seamless; Houston VA, Portland VA, Connecticut VA.

Spectrum Medical is fully integrated into all EMR systems across the country including Cerner allowing for the patient records to be sent to the hospital information system minimizing the risk the chance of losing patient information.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought was posted under RFI 36C24123Q0379. No responses were received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Price is expected to be fair and reasonable based on comparison of proposed prices with acquisition history.

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

Market Research Was Not Conducted: A search for NAICS 334510 in the SBA VetCert, returned 274 results. A DSBS search for NAICS 334510 and keyword “Quantum” returned one SDVOSB. However, after further analysis, it was found they could not provide this requirement.

A Sources Sought Notice was posting from 2/16/23 to 2/21/23. In response to the posting, Spectrum Medical Inc provided a sole source letter indicating exclusive distribution rights. No other responses were received.

Based on the market research conducted, no two or more VIP verified and capable SDVOSBs or VOSBs were identified and appeared capable of performing the requirement. However, one small business provided a sole source letter and can provide the requirement. Therefore, it is recommended to negotiate a sole source contract with Spectrum Medical INC. This market research information is not more than 12 months old.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Our current Heart &

Lung machines are the LivaNova S5 and are 10 years old. To keep pace with current safe techniques and proper patient monitoring, it is vital that our heart and lung machines are up to date. We are in the process of acquiring the Spectrum Medical Quantum 15 workstation (for Electronic Health Record) and updating the heart and lung system to the same company makes for easy integration and eliminate multiple vendors for device maintenance.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No other sources have expressed an interest in the acquisition.

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: N/A

Effective Date: 02/01/2022 Page 3 of 3

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.

Cecily Belgrave Date Health System Specialist VA Boston 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.

SIGNATURE

Deborah Reardon Contracting Officer

NCO1

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.

SIGNATURE

Gail Grundy Branch Chief https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx