AC3 Optimus balloon pump system redacted.pdf

VHAPM Part 819.7007/7008 Page 1 of 4 Original Date: 08/30/2017 Revision 03 Eff Date: 04/03/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-21-AP-1457

1. Contracting Activity: Department of Veterans Affairs, VISN 2, James J. Peter VA Medical

Center 130 West Kingsbridge Road, Bronx, New York 10468. Organizational Activity: New York Harbor Healthcare System Manhattan Campus 423 East 23rd Street, New York, NY 10010 through 2237#630-21-1-3086-0097 seeks to purchase Teleflex (Arrow) AC3 Optimus Intra-Aortic balloon pump system on a non-competitive acquisition.

2. Nature and/or Description of the Action Being Approved:

The proposed action is to purchase as a sole source, firm-fixed price award contract, Teleflex (Arrow) AC3 Optimus Intra-aortic balloon pump (IABP) system for NYHHS Manhattan surgical intensive care department from Marathon Medical Corporation, an SDVOSB vendor. The required Optimus Intra-aortic pump system is needed to replace end-of-life (EOL) equipment currently at use at the facility, which is unable to be repaired. This is a life-saving mechanical device that increases myocardial oxygen perfusion, indirectly increases cardiac output through afterload reduction as well as an emergency back-up to perform heart catherization to rescue patients in the event of cardiogenic shock, dissecting coronary artery, in-retractable chest pain and other heart issues. The following technical specifications for this system are:

Timing Algorithm: WAVE algorithm identifies aortic valve closure on every single heartbeat. With fiber connections allows for a real time signal which provides the best inflation accuracy for AFIB patients.

Best Signal Analysis: Allows the pump to function in autopilot operational mode without staff having to touch the pump.

Precise Volume: Delivery allows clinician to properly access and then occlude the aorta for best augmentation and patient safety.

Helium Tank: Only Teleflex allows staff to continue therapy with no interruptions while changing helium.

R-Wave Timing Algorithm: A removable high-resolution color touchscreen.

Intrabeat Inflation Timing: This accurately inflates the balloon at the speed of light and at a 98% accuracy information for AFIB patients.

Deflation timing management 360-degree viewable illuminating alarm button feature.

Hemodynamics therapy reporting.

VHAPM Part 819.7007/7008 Page 2 of 4

Revision 03 Eff Date: 04/03/2020

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

New York Harbor Surgery department seeks to purchase and upgrade currently in use Teleflex, LLC (Arrow) AC3 Optimus Intra-aortic balloon pump system for patients that require mechanical cardiac support procedures. An Intra-aortic pump is a device used by heart surgeons to treat patients with heart issues. The device consists of a thin, inflatable tube, called a catheter, that is hooked up to a balloon that inflates with a gas container to relieve patients in the event of cardiogenic shock and other ailments associated with the heart. The existing equipment is at “end -of-life and the equipment is beyond repair, so the facility needs to upgrade and replace obsolete equipment in order to care for patients. Here is the Optimus Intra-aortic balloon pump system equipment NYHHS intends to purchase:

Item#ARRW-IAP-0700-AC3 Optimus Intra-aortic Balloon pump system Item#ARRW-IAA-01004-AC3 Optimus accessory bag Item#TLFX-IAA-00175-IV Pole

Total Estimated Value is: $375,475.00 Period of Performance: ARO 8 weeks.

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below:

(x) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business; or () 819.7008 Sole source awards to a verified veteran-owned small business

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

Teleflex, LL (Arrow) is the only company that manufacture AC3 Optimus Intra-aortic balloon pump with FiberOptix capability system. They do not deal or sell directly to VA, but they do have one distributor/reseller (Marathon Medical Corporation), an SDVOSB vendor that sell to VA for them. This system is currently in use at the facility and this is an upgrade to the already existing system. The clinical staff are familiar with the current/older model of the balloon pump system and transferring to the new technology will be used as a seamless integration.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by subpart

5.2 and, if not, which exception under 5.202 applies:

Review of all Government search engines were conducted to find as many potential sources as possible. This included searching Veterans Information Pages (VIP), Small business dynamics (SBS), Non-expendable (NX) Equipment, E-CAT, Strategic Acquisition Center (SAC) mandatory contracts, FPDS, GSA E-library and Contract Opportunities. A

VHAPM Part 819.7007/7008 Page 3 of 4

Revision 03 Eff Date: 04/03/2020

Source sought notice was posted to Contract Opportunities on 03/29/2021. CO received one (1) response from Marathon Medical Corporation an SDVOSB vendor. The results of the searches completed in GSA E-library, ECAT, SAC mandatory contracts and Small business dynamics (SBS) yielded zero (0) potential vendors. Search on Non-expendable contract yielded a similar Intra-aortic balloon pump called Cardiosave Hybrid Intra-aortic balloon pump, this item does not meet the agency’s need because equipment does not perform as above in section V, the AC3 Optimus is the system that is currently being used at the facility and using Cardiosave would mean swapping out the infrastructure in place and retraining the staff.

Based on above criteria, of sections III, V and VI the facility’s investment is greatly reduced by not using a different manufacturer, as all the equipment communicates through a dedicated and proprietary critical care infrastructure that exists within the facility.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Cost was compared to two previous awards found on FPDS using keywords AC3 and Optimus in 2018 and 2019. The two contracts were awarded to Seattle and Dallas VA’s. This information showed CO that price will be fair and reasonable, because it only showed a 2.4% price change within a two to three (2-3) year time period and equipment was ordered through sole distributor for OEM (Marathon Medical Corporation).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

IAW FAR Part 10, market research is detailed in Section VI above. CO also received an email and letter from OEM, that they have only one distributor/reseller that deal with VA for them and that is Marathon Medical Corporation.

Market research also shows that vendor meets criteria outlined in VAAR 819.7003

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:

Marathon Medical Corporation

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:

In order to remove or overcome barriers to competition in future acquisitions for this requirement, the agency would have to continue to review the marketplace to determine if new products/technology is such that it could be cost-effective to replace entire existing physiological Intra-aortic pump system.

VHAPM Part 819.7007/7008 Page 4 of 4

Revision 03 Eff Date: 04/03/2020

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.

Date

Chief Biomedical Engineering VA NYHHS Manhattan

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.

Date

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Date

Branch Chief (Supply Team 1 & Prosthetics) Network Contracting Office 2

Date: 2021.04.21 15:56:29 -04'00'

04/21/2021Date: 2021.04.21 16:05:57 Aleta Jennette Contracting Officer Network Contracting Officer 2