36C25918Q9723-001.doc

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

1. Acquisition Plan Action ID: VA259-18-AP-4229

2. Organizational Activity

Department of Veterans Affairs, NC0 19

Oklahoma City Medical Center

6162 South Willow Drive, Suite 300

921 NE 13th Street

Greenwood Village, CO 80111

Oklahoma City, OK 73104

The procurement request number, 2237, is 635-18-2-071-0050.

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

The procurement is for a new firm-fixed price contract for 10 each Medtronic 980 Puritan Bennett Ventilators, including cylinder mounts, humidifier brackets, wall air water traps, batteries, and starter kits with nebulizers for acute ventilator and life-sustaining management for acutely ill patients. This action allows for a special ventilator mode that facilitates an increase in weaning of the patient.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for Medtronic 980 Puritan Bennett Ventilators 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.

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

Ventilators are a vital part of the facility’s ability to manage critically ill patients who exhibit life changing events. Services requested are for local ventilator management of the acutely ill patients within the VA’s Medical, Surgical, and Coronary Care Units. The inability to provide this service would require transport of patients to other facilities for treatment which could lead to the demise of the patients. 980 Puritan Bennett Ventilators, manufactured by Medtronic, are the only ventilators that communicate with the patient’s data monitor which in turn communicates with the PI Client Information System (PICIS).

5. 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;

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

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

This acquisition is being procured on a brand name basis for the following reasons. The 980 Ventilators, manufactured by Medtronic, are the only ventilators that communicate with the patient’s data monitor which in turn communicates with the PI Client Information System (PICIS). Currently, the Oklahoma City VA Medical Center is currently in possession of ten 980 Ventilators. They are already configured to provide the necessary mode to provide life-sustaining ventilation to all critically ill patients. The new ventilators are required to have the same mode of ventilation; therefore, only Medtronic 980 Ventilators can be configured with the same mode of ventilation. No other ventilator will have the same mode of ventilation. Without these ventilators, the VA is unable to provide life-sustaining ventilator management to critically ill patients. Additionally, the VA’s current fleet of ventilators are not repairable and cannot be updated with software allowing monitoring of the patients’ status by the new PICIS charting system.

7. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The solicitation will be posted on www.fbo.gov.

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

The CO has determined that the anticipated cost will be considered fair and reasonable based on adequate price competition as there are at least three (3) SDVOSBs which are authorized to sell the Medtronic brand ventilators to the VA. If adequate price competition is not obtained, final contract prices will be determined fair and reasonable through comparison of the quoted prices with the manufacturer's catalog list prices. In addition, there are trade-in prices to be considered for this procurement.

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

The NAICS for this procurement is 339112, Medical Equipment. Resulting from market research, the Medtronic brand ventilators are the only ones which meet the VA’s needs because of the special vent mode and the ventilator’s ability to communicate with the PICIS. Pursuant to the Veterans First Program, the manufacturer was asked if any SDVOSBs/VOSBs are authorized to sell the required product to the VA. Per the manufacturer, there are three (3) SDVOSBs which are authorized.

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

There are no other facts supporting the use of other than full and open competition.

11. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: One SDVOSB has expressed, in writing, an interest in the acquisition. There are three (3) SDVOSBs authorized by the manufacturer to sell the products to the VA.

12. 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:

The Government will continue to conduct market research to ascertain if there are changes in the market place related to the ventilators which have the special vent mode and the ability to communicate with the PICIS. As innovative technology increases, future orders for ventilators will be reviewed for competition.

OFOC SOP Revision 08

Original Date: 03/22/11

Revision 08 Date: 04/18/2018