J and A FAR Part 13.501_ Ventilator signed_Redacted.pdf

CUI

Control Number: FY25-0425

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024

CUI//PROCURE

Controlled by: Defense Health Agency (DHA) Controlled by: Healthcare Contracting Division-Southeast CUI Category: Source Selection Limited Dissemination Control: FEDCON

POC:

Justification and Approval (J&A) Modified for Federal Acquisition Regulation (FAR) 13.501

1. Identification of the Agency and Contracting Activity: This justification for other than full and open competition is executed by the Defense Health Agency (DHA), Southeastern Healthcare Operation Division, Fort Detrick, MD on behalf of the DHA to meet the needs of Naval Medical Center Camp Lejeune.

2. Nature and/or Description of Action being Approved: The purpose of this action is to award a contract on a sole source basis for Full-service maintenance for Puritan Bennett 980 ventilator (PB980). Services were previously provided under contract N6809320P0022 by Covidien Sales, LLC (Cage Code: 6VKK4).

The government intends to award a single Firm-Fixed, Price (FFP) P-type contract for a base plus four (4) options periods. The proposed contractor is Covidien Sales LLC, 15 Hampshire St Mansfield MA, 02048 (Cage Code: 6VKK4).

3. Description of Supplies/Services: This requirement is for comprehensive maintenance and repair services for Covidien PB980 ventilators, including preventative maintenance, corrective maintenance, battery replacement, calibration services, and emergency repair services. The PB980 ventilators are critical life-support equipment used in intensive care units and emergency departments to provide mechanical ventilation to patients with respiratory failure or insufficiency. These ventilators feature advanced monitoring capabilities, multiple ventilation modes, and integrated safety systems that require specialized knowledge and manufacturer-specific tools for proper maintenance and repair. Ventilators located at Naval Medical Center Camp Lejeune (NMCCL), 100 Brewster Blvd, Building 100, Camp Lejeune, NC, 28546

Manufacture Serial Number Equipment Control Number 35B1402154 116552 35B1500011 116551 35B1500658 116550 35B1500686 116553 35B1701757 120566

CUI

3 NOV 2024

6. Efforts to Obtain Competition: A quote was requested from Covidien Sales, LLC for the requested services. Covidien Sales, LLC also submitted a sole source letter indicating that they are the only company that is authorized to provide the services while maintaining their warranty on the equipment. This requirement will be publicized as required by FAR Subpart 5.2.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: The MTF will continue to monitor the market for additional authorized service providers for PB980 ventilator maintenance. However, due to the proprietary nature of the equipment and manufacturer restrictions on authorized service providers, competition remains limited. The MTF will consider alternative ventilator platforms in future procurements to increase competition opportunities.

8. Market Research: Market research was conducted, and it was determined that no mandatory sources could perform the required PB980 ventilators maintenance services. A Dynamic Small Business Search (DSBS) yielded no viable small business sources our capable of providing the required service as Covidien Sales LLC, a Medtronic company is the only provider of the Original Equipment Manufacturer parts, field service engineers, and the proprietary associated parts, accessories and applicable licensed software applications to maintain the PB980 ventilators per Covidien Sales LLC letter dated 18 February 2025. As a result, this requirement will be procured as other than full and open competition. A Notice of Intent (NOI) to sole source will be posted on SAM.gov for 5 days. If another company submits a written interest in this requirement as a result of the announcement, the company’s information will be evaluated to determine whether to conduct a competitive procurement or to proceed with a sole source contract.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

(2) If 9.a.(1) is No, was the action just prior to this one competed? No

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? Not applicable.

b. Additional Information: Previous contract was N6809320P0022 which was awarded for a base plus four (4) options for the same services from 20 July 2022 through 19 July 2025, total award $160,055.68. This requirement was previously procured by Naval Medical Center Camp Lejeune contracting activity. Therefore, the contract files and previous justifications were not available. SAM.gov was searched for any records of postings of the J&A or award documentation; no records were located.

CUI

6 NOV 2024