36C24419Q0922-001.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C244-19-AP-3653

1. Contracting Activity: Department of Veterans Affairs, VISN 4, PITTSBURGH Medical Center

646-19-3-233-0282

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

This is a new request for the Getinge Magnus Floor Mounted Hybrid OR Interchangeable Top Surgical Table. This table is a base floor mounted table with interchangeable tops allowing the table to be utilized for Endo Cardiovascular surgery and Open Surgical Procedures.

3. Description of Supplies/Services :

Magnus Hybrid OR Surgical table with Interchangeable table tops is made up of:

Floor Mounted Base that can be rotated 320 Degrees Table column and installation CV Imaging Table Top with Transporter, adjustable side rails, accessory adapter, central torso element, socket for corded devices, head rest mounting point, joystick, IR remote, Foot Control, & 550 pd weight capacity

General Surgical Table Top with transporter, hand control, socket for corded devices, head rest mounting point, joystick, IR remote, Foot Control, & 550 pd weight capacity

Magnus warranty Total cost of Procurement

This table will be delivered to the VA Pittsburgh University Drive Location

4. Statutory Authority Permitting Other than Full and Open Competition:

(x) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

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

The Pittsburgh VA Medical Center needs the Getinge Magnus Hybrid OR Surgical Table with interchangeable tops for the Hybrid OR that is under way for Construction. This vendor can provide both radiographic and surgical compliant table tops, which will enable VA Pittsburgh to expeditiously change to an open cavity procedure from the more minimally invasive approach. This will minimize patient safety compromises that will arise in delay in conversion.

VA Pittsburgh is planning on activating a surgical suite capable of completing trancatheter aortic valve replacement (TAVR), Endovascular Abdominal Aortic Aneurysm repair and Open Heart Surgery procedures. The Maquet Magnus table consists of components that interface with the Seimens Floor Mounted Artis Pheno Robotic System to comprise a surgical system. This will allow for a comprehensive team of surgeons, interventionalists, nurses, anesthesiologists, and technicians to work seamlessly together. To be a responsible steward of government dollars and be more proactive with spending, VA Pittsburgh has based the design for floor construction off the dimensions of this specific table. This is in conjunction with the floor mounted solution mentioned above. The table allows the surgeon to reposition the patient without having to move equipment. This allows for the reduction of procedure time and will allow the facility to better utilize the room. Maquet is the sole manufacturer of a table that is designed to be compatible with the requested Artis Pheno Robotic System.

Currently approximately 40 veterans a year are being Fee-Based out to the community for TAVR procedures costing the VA millions of dollars in care on top of supply fees that could be performed here at the VA. Once the VA has this Hybrid OR with all of the needed Equipment then it is foreseen that the Veteran Population for needing this Procedure will Grow.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Market Research was conducted via internet search, GSA and VIP with negative results for other suppliers / distributors of the table.

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

Cost is inline with industry cost.

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

Market Research Was Not Conducted:

Market research was conducted of all tables that would be compatible with the requested Robotic Hybrid System. Getinge was the only vendor that was in response to the request and works hand in hand with the vendor for the Robotic System

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Getinge has a Affiliate relationship with Siemens for the Compatibilty of Hybrid OR equipment and providers of medical products for operating rooms, cath labs, and intensive care units, and has extensive experience with hybrid that meet and exceed the most demanding requirements. This boosts efficiency, optimizes workflow, and increases throughput.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None

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:

Market research will be conducted to see if other manufacturers / tables on the market will meet the need.

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.

Name Date Title Facility

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

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

_____________________________ June 20, 2019 Andrea Aultman-Smith Date Contracting Officer NCO 4, Commodities 1

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

Leslie Adam Byrson Date Branch Chief

NCO4 Commodities 1