A02. Sole Source Justification under the SAT_Final (2)_Redacted.pdf

CUI

Control Number: FY25-0373

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA CUI Category(ies): Source Selection Limited Dissemination Control: FED Only POC: Shannon Houser, shannon.m.houser.civ@health.mil

Source Selection Information - See FAR 2.101 and 3.104-4

NOV 2024

Sole Source Justification (SSJ) for Requirements under the Simplified Acquisition Threshold

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), Defense Centers for Public Health – Aberdeen (DCPH-A) and The United States Army Medical Research Acquisition Activity (USAMRAA).

2. Description of Action: This is a Firm Fixed Price equipment maintenance contract for instrumentation produced by Roche using Operation and Maintenance funding.

New Requirement Purchase Order ☐ Blanket Purchase Agreement (BPA) ☐ Order against BPA # Click or tap here to enter text.

☐ Order against Multiple Award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract # Click or tap here to enter text.

☐ Order against Single Award IDIQ Contract # Click or tap here to enter text.

☐ Order against Federal Supply Schedule Contract # Click or tap here to enter text.

Follow-on Requirement to Contract/Order # Click or tap here to enter text.

Modification against existing Contract/Order and Modification # Click or tap here to enter text.

Contract Type Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid Click or tap here to enter text.

3. Description of Services or Supplies and Estimated Value: A Roche equipment maintenance contract will cover annual preventive maintenance, repair support visits, parts, and software support. This service is required to meet manufacturer standards, but more importantly, it is mandatory to meet laboratory quality and accreditation standards.

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☐ FAR 8.405-6(a)(1)(B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

FAR 8.405-6(a)(1)(C) In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

FAR 8.405-6(b)(1) Items peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.

Or

☐ FAR 16.505(a)(4) Items Peculiar to One Manufacturer☐ FAR 16.505(b)(2)(i)(A) The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

☐ FAR 16.505(b)(2)(i)(B) Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

☐ FAR 16.505(b)(2)(i)(C) The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

☐ FAR 16.505(b)(2)(i)(D) It is necessary to place an order to satisfy a minimum guarantee.

5. Reason for 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

NOV 2024

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. 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 authorize any other company to service their equipment. In addition, the Government confirmed with the incumbent (Goldbelt Frontier) that they do not have a service agreement in place with Roche but instead contact Roche on an as-needed basis for individual visits. 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.

7. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

(2) If 7.a.(1) is No, was the action just prior to this one competed? Yes – this was previously issued as a task order (HT942524F0327) off a single-award Indefinite Delivery Indefinite Quantity (IDIQ) contract (W81XWH20D0062) covering general equipment maintenance. The IDIQ contract was competed under full and open competition with only one selected awardee.

283) If 7.a.(2) is Yes, what has changed where this action cannot be competed? The last day to order under IDIQ contract W81XWH20D0062 is 04 September 2025, and USAMRAA does not intend to issue a replacement IDIQ contract. Task Order HT942524F0327 expires on 04 September 2025. As a result, issuing another task order off this same IDIQ contract is not possible. The Contracting Officer is aware that the Defense Health Agency has another time and materials, single-award IDIQ contract (W81K0423D0006) with Agiliti Health Inc. for general equipment maintenance, but 100% of the services would still be subcontracted to Roche. To mitigate risk of delays resulting from working through a third party as well as to better manage expenditures of taxpayer dollars, the Contracting Officer believes a sole source award is the best option to the Government.

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b. Additional Information: Not Applicable

8. Technical Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Shannon Houser Contracting Officer’s Representative Defense Centers for Public Health - Aberdeen

9. Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Shannon Houser Contracting Officer’s Representative Defense Centers for Public Health - Aberdeen

10. Fair and Reasonable Cost Determination:

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for Determination: The Contracting Officer anticipates determining the future quoted price fair and reasonable based on a comparison with prices found reasonable on previous purchases (task orders HT942524F0327 and/or W91ZLK21F0246).

Jesse Nisley Contracting Officer U. S. Army Medical Research Acquisition Activity

HOUSER.SHANNO

N.MARIE.10437047

Digitally signed by

HOUSER.SHANNON.MARIE.104

3704768 Date: 2025.08.27 08:04:51 -04'00'

HOUSER.SHANNO

N.MARIE.10437047

Digitally signed by

HOUSER.SHANNON.MARIE.104

3704768 Date: 2025.08.27 08:05:03 -04'00'

NISLEY.JESSE.D

ALE.1538574682

Digitally signed by

NISLEY.JESSE.DALE.15385746

Date: 2025.09.24 09:37:13 -04'00'

NOV 2024

11. Contracting Officer Determination:

I certify this justification is accurate and complete to the best of my knowledge and belief.

Jesse Nisley Contracting Officer U. S. Army Medical Research Acquisition Activity

NISLEY.JESSE.D

ALE.1538574682

Digitally signed by

NISLEY.JESSE.DALE.15385746

Date: 2025.08.28 15:45:11 -04'00'