JA_USARIEM_LSU_redacted_Redacted.pdf

J&A Control No. JA-19-02-0063

For Official Use Only

Justification and Approval for Other Than Full and Open Competition

1. Contracting Activity: The contracting activity for this action is the US Army Medical Research Acquisition Activity (USAMRAA), on behalf of the US Army Research Institute of Environmental Medicine (USARIEM), Natick, MA.

2. Description of Action: This will be a new single award Indefinite Delivery Indefinite Quantity (IDIQ) contract for analytical biochemistry services Funding will be provided at the task order level. The ordering period for the IDIQ will be for five (5) years.

3. Description of Supplies/Services: The Government requires an IDIQ contract with Louisiana State University/Pennington Biomedical Research Center (LSU/PBRC) to provide analytical biochemistry services of human urine, blood (plasma/serum/whole blood/red blood cells (RBC)), fecal, saliva, muscle, and wound fluid samples, and rodent plasma/serum samples. The results will be provided in the form of a spreadsheet, as well as assistance with data interpretation and publication. This will be a Firm Fixed Price IDIQ contract. The total estimated value for five years is . The results of this work will provide data needed to fulfill requirements of approved and planned human and animal research protocols.

4. Authority Cited: 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(iii)(A), services may be deemed to be available only from original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition.

5. Reason for Authority Cited:

USARIEM requires biochemistry analyses methods and data consistency in support of research study protocols. The two most critical aspects of the nutritional biochemistries analyses services are: (1) the tests be conducted in a clinical chemistry laboratory that is accredited by the Centers for Medicare and Medicaid Services (CMS/CLIA) and the College of American Pathologists (CAP) that also participates in standardization programs and follows Good Clinical Practice (GCP) guidelines, (2) the nutritional biochemistries be analyzed using the same methodology that has been utilized in prior USARIEM field studies and laboratory studies in order to be able to reliably compare results across studies. Louisiana State University (LSU)/Pennington Biomedical Research Center (PBRC) is uniquely qualified to perform these services as they meet all of the critical aspects for the nutritional biochemistries analyses. LSU/PBRC has provided 30 years of accurate analytical laboratory results in support of USARIEM research. During this affiliation, LSU/PBRC and USARIEM have operated in a unique collaborative relationship that has resulted in the completion of over 130 projects which have led to significant improvements in operational rations, better understanding of Warfighter nutritional requirements and modifications in garrison feeding. To date, the total value of the grants and contracts awarded in support of that relationship is approximately $75 million.

The proposed IDIQ is related to and will extend the prior USARIEM field studies and laboratory studies supported by LSU/PBRC thereby enabling USARIEM to continue its research mission of determining Warfighter nutritional requirements. In order to further this work, and allow valid comparisons to prior USARIEM studies, the same methodology must be employed in the current/upcoming studies. Similar methodologies may be found in other organizations, but other organizations do not provide the full spectrum of biochemistry analyses required. LSU/PBRC is the only source that provides the full spectrum of required biochemistry analyses. Further, there is variability in the performance of the assays, and hence variability in results between labs. This makes it critical that samples from current/planned experiments utilize the same methodology in the same laboratory in order to allow direct comparisons between studies. Without this continuity, the scientific integrity and validity of comparing results across studies will be compromised, and studies that otherwise would not need to be repeated, could need to be repeated. Given the long affiliation between USARIEM and LSU/PBRC, significant costs would be incurred to repeat those studies which that have provided the foundation for current and planned USARIEM-led research.

6. Efforts to Obtain Competition A Sources Sought was posted to Federal Business Opportunities (FBO) on 11 December 2018 for seven (7) calendars days in order to determine whether there were any viable candidates with the knowledge, experience and/or capability of providing these specific biochemistry analyses services outside of the LSU/PBRC, however, no responses were received.

a. Effective Competition: No effective competition is anticipated for this acquisition.

b. Subcontracting competition: There is no potential for subcontracting opportunities under this acquisition.

7. Actions to Increase Competition: Competition of the requirement is not possible due to the established research and the capability to do direct comparisons of prior findings using the same methodology with current required upcoming studies. Using alternative performers would hamper comparisons of scientific results across studies potentially leading to erroneous conclusions, and would incur unnecessary costs to repeat previously completed experiments.

8. Market Research: USARIEM conducted market research through System for Award Management (i.e. SAM.gov), using multiple search terms and criteria, specific to this effort, and found no businesses (large or small) with the capabilities to conduct the biochemistry analyses. USAMRAA also did market research in doing a sources sought/request for information (RFI) on FBO from 11 December to 17 December 2018.

No responses were received from the posted announcement. Based on market research, the Government has determined that the only viable vendor/resource with the capabilities to conduct this effort is LSU/PBRC.

9. Interested Sources: A notice to sole source was posted on FBO from 20 December 2018 to 20 January 2019, no responses were received from industry.

10. Other Facts: Discuss any other facts supporting the use of Other Than Full and Open Competition, such as the following

a. Procurement History:

(1) Contract numbers and dates of the last several contracts for these same requirements: Grant W81XWH-14-1-0335 (9/1/14 – 8/31/17) and IDIQ contract W81XWH-17-D-0038 (8/25/17 – 8/24/22).

(2) Competitive status of these actions; W81XWH-14-1-0335 through the BAA, W81XWH-17-D-0038 sole source

(3) Authority previously used for less than full and open competition:

6.302-1(a)(2)

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results:

Competition for this requirement is not possible due to established research and the capability to do direct comparisons of prior findings using the same methodology with current required upcoming studies.

The findings from the previous sole source remain the same.

(5) If any prior award was accomplished by full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources: N/A

(6) An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive, urgent buys: N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes: The proposed studies in the previous procurement were related to four USARIEM field studies (2,500 samples), the analysis from that procurement are directly related from that established research line which is evaluating the effects of initial military training on nutrition status. It is critical that samples from current/planned experiments utilize the same methodology in the same laboratory in order to allow direct comparisons between studies. There are no significant changes.

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated: Not Applicable

11. Technical Certification:

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

Signature:

12. Requirements Certification:

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

Signature: _______________________

13. Fair and Reasonable Cost Determination:

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

Basis for determination: In accordance with FAR 15.404-1(b)(2)(v), the Government will use the Independent Government Cost Estimate (IGCE) in combination with FAR 15.404-1(b)(2)(ii) Comparison of proposed prices to historical prices paid, in order to determine whether the proposed cost/price is fair and reasonable. In accordance with FAR 15.403-4 certified cost or pricing data will be required.

Signature:

14. Contracting Officer Certification:

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

Signature: ______________________

15. Legal Sufficiency Review:

Based on the information provided in this document, I hereby determine this justification for other than full and open competition to be legally sufficient.

Signature: ______________________

Approval Special Advocate for Competition

Based on the foregoing justification, I hereby approve the procurement of analytical biochemistry services on an Other Than Full and Open Competition basis pursuant to the authority of 10 U.S.C.2304(c) Federal Acquisition Regulation 6.302-1(a)(2), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: _____________________________