D03 - JA FY25-0348 Redacted.pdf

CUI

Control Number: FY25-0348

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA CUI Category: Source Selection Limited Dissemination Control: FED ONLY POC: Jeffrey Sprecher

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024

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

1. Identification of the Agency and Contracting Activity: The contracting activity for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), Contracts Group 2.

2. Nature and/or Description of Action being Approved: The requiring activity for this action, the Armed Forces Medical Examiner System (AFMES), Division of Forensic Toxicology (DFT), requires a sole source service contract for two (2) Hamilton Company STARlet instruments currently owned by DFT. The requirement is for a Base 12-month Period plus four 12-month Option Periods. The resultant contract will be a firm fixed price contract.

3. Description of Supplies/Services: This requirement is for a maintenance service contract for preventative and corrective maintenance, telephone support, hardware upgrades, and software services for two (2) Hamilton Company STARlet instruments currently owned by DFT.

Hamilton Company, 4970 Energy Way, Reno, Nevada 89502 is the only source capable of providing this service. The intended Period of Performance for the base Period will be 26 September 2025 through 25 September 2026.

The estimated value, to include all options, is . Funds will be FY 25 Operation and Maintenance.

Period Period of Performance or Required Delivery Date

Estimated Value Type of Funding

Base Period 26 September 2025 through 25 September 2026

OM

Option Period 1 26 September 2026 through 25 September 2027

OM

Option Period 2 26 September 2027 through 25 September 2028

OM

Option Period 3 26 September 2028 through 25 September 2029

OM

Option Period 4 26 September 2029 through 25 September 2030

OM

Total

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 (including brand name) under the authority of the simplified procedures for certain commercial item.

5. Rationale Justifying Use of Authority Cited: A Sole Source requirement is essential for AFMES DFT to maintain operation capabilities. The AFMES DFT mission provides toxicological examination for military autopsies, aircraft incidents, criminal investigations (including drug-facilitated sexual assaults and DUI/DWI), fitness-for-duty inquiries, and selected cases of national interest. Each year the DFT processes more than 15,000 cases, many of which directly affect operational readiness and/or national security. The results obtained from these instruments require exacting accuracy and precision. Original Equipment Manufacturer (OEM) have the direct expertise to insure the high reliability in operation and reporting. The equipment must be maintained within the original equipment manufacturer (OEM) specifications, in like new or better condition. Only Hamilton Company is capable of providing maintenance of their equipment to maintain certifications and tolerances. Inability to maintain the equipment would impact AFMES DFT laboratory accreditation. Due to the nature of our mission and the exactness required in performing various drug screening/testing procedures, it is imperative that and functionality are not compromised during any equipment maintenance services.

Failure to award this requirement to Hamilton Company could invalidate current standardized analytical drug testing procedures and would result in numerous man-hours being used to correct any deficiencies. The method validation process would months to complete and during this time the DFT would not be able to report any case results. This type of stoppage would be detrimental to all military contributors worldwide and delay the release of death certificates, testing results for ground flight crews involved in mishaps, and delay all criminal and fit for duty investigations. Failure to award this contract immediately could lead to suspended laboratory testing which impacts missions throughout the DoD.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by

FAR 5.201.

To date, no other sources have expressed written interest in the required tasks.

A notice of intent to sole source this modification will be posted to SAM.gov.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

AFMES DFT will continue to survey the market to identify companies capable of providing maintenance to Hamilton Company equipment that may become available. At present, Hamilton Company is the only solution to meet AFMES DFT appropriate if the AFMES DFT purchase of new equipment.

Working in collaboration with the Contracting Officer, the AFMES DFT will seek competition to the greatest extent practicable.

3 NOV 2024

8. Market Research: Market research, to include vendor searches in SAM and Online searches, completed in June 2025 indicates that the only available source is Hamilton Company.

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? Yes, the current contract that provides maintenance for the equipment, W81XWH19P0174, was competed as a Brand Name or Equal solicitation for Hamilton Company Brand equipment with Option Periods for on-going maintenance.

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? The current contract was for the initial purchase of the equipment and included maintenance. The maintenance on the current contract ends on 25 September 2025.

Only the OEM can provide the required maintenance, thus this procurement will be a sole source purchase.

b. Additional Information: N/A

10. Interested Sources:

Hamilton Company To date, no other sources have written to express an interest. The notices required by FAR 5.201 shall be published, and that any bids or proposals received shall be considered.

4 NOV 2024

11. 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.

12. 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.

5 NOV 2024

13. 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 price will be determined fair and reasonable in comparison with the Independent Government estimate as well as price analysis.

14. Contracting Officer Certification:

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