A.02 Sole source JA PANTHER Fusion Maintenance and Repair FY24 signed_Redacted.pdf

CUI//SP-PROCURE

Solicitation Number: W91YTZ24Q0098 Control Log Number: 24-RHCO-A-242

Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold

(Simplified Acquisition Threshold is $250K)

1. Contracting Activity:

Medical Readiness Contracting Office – East (MRCO-E) Fort Liberty Contracting Cell 9275 Doerr Road, Building 1221 Fort Belvoir, VA 22060

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: DHP Total Dollar Value:

Name of Intended Contractor: Hologic Street Address: 10210 Genetic Center Drive City, State, Zip: San Diego, CA 92121

Phone: (856) 410-8751

Period of Performance:

Base Year CLIN 0001, 01 September 2024 -31 August 2025 Option Year 1- CLIN 1001, 01 September 2025-31 August 2026 Option Year 2- CLIN 2001, 01 September 2026-31 August 2027 Option Year 3- CLIN 3001, 01 September 2027-31 August 2028

3. Description of Supplies/Services: Contractor shall perform preventive maintenance; repair and parts replacement services for Government-Owned Hologic Panther Fusion System: ECN# 096635.

The equipment life cycle is expected to end in April 2028. The equipment was purchased in April of 2020 with an 8-year life cycle. Model # 912090000, Serial # 2090002112, and its components. The system and components are located in the Microbiology Lab, Womack Army Medical Center (WAMC), Ft. Liberty, North Carolina. The Contractor shall maintain the system in a fully functional condition in accordance with the Original Equipment Manufacturers (OEM) specification as stated in this Performance Work Statement. The panther fusion assay can be used to test nasopharyngeal (NP) and oropharyngeal (OP) swab specimens, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage specimens. Common cold flu and SARS-CoV-2 are common reagents processed on this equipment.

Controlled by: USAHCA CUI Category: SP-PROCURE Limited Dissemination Control: FED ONLY POC: Kimberly Jackson (803) 846-9956

4. Authority Cited:

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

(d) FAR 8.405-6(a)(1)(i)(B): Only one source can provide the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; OR

(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

5. Reason for Authority Cited: This is a limited source requirement with the (Original Equipment Manufacturer) recommended as the only authorized vendor to service, repair and replace parts for the government owned the Panther Fusion system. The proper operation of this system is dependent upon propriety software, which is only available from the original equipment manufacturer. A proprietary letter dated 15 May 2024 was received from the Vice President of Hologic stating there are no authorized third-party service providers for the panther fusion system (PCF location A.02, Proprietary Letter Service). If the Panther Fusion System is inoperable for an extended period, this will cause patients to be referred to an outside provider at considerable additional cost. Failure to provide services will significantly impact patient safety and overall healthcare to servicemembers and their families.

6. Actions to Increase Competition: The action was synopsized on SAM.gov on 11 May 2024 to increase competition. One response was received from BHPE LLC. When asked to provide a capability statement there was no response received. No further action will be taken to increase competition based on the proprietary nature of the equipment and services.

7. Market Survey: Market research was conducted in accordance with FAR Part 10. The following techniques were used: A review of the Dynamic Small Business search based on NAICS code 811210 and key words for Panther Maintenance. The search showed that there was no small business that met the search criteria. Hologic is the only authorized service provider of parts and equipment required to run the Panther Fusion platform.

8. Procurement History:

Previous Contract or Purchase Order Number: W91YTZ23P0074 Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization.

9. Technical / Requirements Certification: I certify that the supported data under my cognizance which are included in this mini-J&A is accurate and complete to the best of my knowledge and belief.

I certify the required services are not available using mandatory sources and delivery cannot be made by the required delivery date except by obtaining the services pursuant to this sole source acquisition.

Signature:

Submitted By: Linda M. Jones Position Title: Chief, HTMB

Email address: linda.m.jones124.civ@health.mil Date: 12 July 2024

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. I have determined that the anticipated cost to the Government for this contract action will be fair and reasonable. Fair and Reasonable determination will be based on historical prices and the Independent Government Estimate. Certified cost or pricing data is not required per FAR 15.403-1(b)(3), because the items are commercial in nature.

Signature:

Typed Name: Michael McCollum Position Title: Contracting Officer

Email address: Michael.j.mccollum12.civ@health.mil

JONES.LINDA.M

AE.1159493845

Digitally signed by

JONES.LINDA.MAE.1159493845

Date: 2024.08.08 10:47:49 -04'00'

MCCOLLUM.MICH

AEL.JAMES.128759

Digitally signed by

MCCOLLUM.MICHAEL.JAMES.1

287594409 Date: 2024.08.08 10:36:52 -04'00'