A02. Justification and Approval Modified for FAR Part 13.501_Redacted.pdf

CUI

Control Number: FY25-0373

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

2 NOV 2024

4. Statutory Authority Permitting the Sole Source Acquisition: 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source Roache Diagnostics Corporation under the authority of the simplified procedures for certain commercial items.

5. Rationale Justifying Use of Authority Cited:

a. Roche Diagnostics Corporation is the proprietary service provider for Roche

Instrumentation. While these services have historically always been issued through a third party, the third party would subcontract 100% of the services to the manufacturer.

The manufacturer is registered with the Government in sam.gov and is eligible to receive contract awards. The current task order performing these services (HT942524F0327) is through a third party using a hybrid time and materials (for servicing the equipment) and firm fixed price (to coordinate with the manufacturer) contract types. The time and materials contract type is described in FAR 16.601(c)(1) as not providing any positive profit incentive to the contractor for cost control or labor efficiency. A service agreement was also not established with the manufacturer under that task order, and the Contractor only reaches out to the manufacturer on an as-needed basis for individual visits. Per the Roche organization: “Roche does not authorize or certify third party service providers of our services in the United States; only Roche engineers are trained by Roche for the purposes of selling such maintenance services in the United States.” Other similar contracts have found that manufacturers do not consider maintenance of equipment through third parties to be high priority. DCPH-A has learned that service agreements with the original equipment manufacturer or an entity authorized to work on the equipment directly result in better quality services and prompt turnaround times.

b. If these services are awarded to anyone other than Roche Diagnostics Corporation, the

Government risks the inability to speak with the manufacturer directly, delays in servicing the equipment, and additional expenses tacked on top of what the original equipment manufacturer charges.

6. Efforts to Obtain Competition: A Notice of Intent to Sole Source was posted on 28 July 2025 with any responses due by 18 August 2025. No responses were received from this posting.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: The Government examined all possible strategies to increase competition before moving forward with the justification. The requirement was synopsized on the Governmentwide Point of Entry (GPE) at sam.gov via a Notice of Intent to Sole Source for a period of 15 days (in accordance with FAR subpart 5.2). The notice was posted on 28 July 2025 with responses due on 18 August 2025. No responses were received from this posting.

8. Market Research: Between Nov 2024 and July 2025, the anticipated Contracting Officer’s Representative, Contract Specialist, and Contracting Officer conducted market research for this acquisition. The Government confirmed with Roche Diagnostics Corporation that they do not