Justification_for_Other_Than_Full_and_Open_Competition_Redacted.pdf

Naval Medical Logistics Command Justification and Approval

NMLC LOG #16-10142

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity:

The Justification and Approval (J&A) is executed by the Naval Medical Logistics Command (NMLC), 693 Neiman Street, Fort Detrick MD 21702 on behalf of the requesting agency:

Naval Medical Research Center (NMRC), Bone Marrow Research, Rockville, MD.

2. Description of the Action Being approved:

The proposed action is to acquire a Big Dye Terminator (BDT) v1.1 RR-5000 & Sequence Buffer, POP-7 polymers, and 5X Sequence Buffer Bottles. The Government intends to award a Firm Fixed Price contract. The proposed source is Life Technologies Corporation, 3175 Staley Road, Grand Island, NY 14072-2090.

3. Description of the supplies or services required to meet the agency's needs:

NMRC has a critical need for the purchase of BDT v1.1 RR-5000 & Sequence Buffer, POP-7 Polymer Bottles, and 5X Sequence Buffer Bottles. The BDT v1.1 is a chemistry system that results in one of four highly specific fluorescent molecules, one each representing adenine, guanine, cytosine, or thymine, the four bases used by most organisms including humans to code for all genes. These four colored fluorescent molecules are the four colored markers detected by the Deoxyribonucleic acid (DNA) sequencing equipment, the Applied Biosystems (ABI) 3730x1 DNA analyzer used for the Human Leukocyte Antigen (HLA) genetic tests. The test system tests HLA molecular strings (exons) representing the part of the HLA gene that gives HLA its biologic function (called antigen recognition site) and associated unique sequence of DNA bases. Each string of bases is 200 – 350 bases in length and is considered a short reading sequence.

BDT v1.1 RR-5000 has been optimized by the Bone Marrow Research Directorate for DNA sequencing applications that are performed on the ABI 3730x1 DNA analyzer. BDT v1.1 RR-5000 delivers increased robustness, high quality data, and improves the success with difficult DNA sequences. POP-7 Polymer is a separation matrix for the 3730 and 3730xl DNA Analyzers. POP-7 Polymer is customized for DNA sequencing and fragment analysis. This sequencing buffer is optimized for use with BDT v1.1 and V3.1 Cycle Sequencing kits.

The contract is anticipated to have multiple delivery dates over a 12-month period.

4. Statutory Authority Permitting Other than Full and Open Competition:

10 U.S.C. 2304 (c)(1) (as implemented by FAR 6.302-1); Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Rationale Justifying Use of Cited Statutory Authority:

Naval Medical Logistics Command Justification and Approval

NMLC LOG #16-10142

Life Technologies Corporation is the only producer, manufacturer, and distributor of the BDT v1.1 kits that are fully quality controlled under the ABI 3730xl DNA analyzer. POP-7 Polymer is a separation matrix for the 3730 and 3730xl DNA Analyzers. POP-7 Polymer is customized for DNA sequencing and fragment analysis. This sequencing buffer is optimized for use with BDT v1.1 and V3.1 Cycle Sequencing kits.

These reagents (BDT v1.1) have been optimized by the Bone Marrow Research Directorate for DNA sequencing applications that are performed on the ABI 3720xl DNA Analyzer as required for acceptable clinical and research results needed for marrow transplantation. BDT v1.1 delivers increased robustness, high quality data, and improves the success with difficult DNA sequences. The Bone Marrow Research Program currently utilizes two ABI 3730xl DNA analyzers, which require the BDT v1.1 sequencing kits in order to operate the instrument and there are no acceptable alternative reagents. The 3730xl DNA analyzer product literature outlines the compatibility of the Life Technologies proprietary reagents with the DNA analyzer. These reagents are used to perform clinical and bone marrow research projects. The DoD Bone Marrow Program has been able to demonstrate on the HLA genes: sequence base typing (SBT), Killer Cell Immunoglobulin-like Receptor (KIR) genes SBT, and detection of HLA and KIR novel genes using these reagents. HLA and KIR genes typing are very critical for the treatment of leukemia patients and improving bone marrow transplant outcomes. The facility is unable to perform any HLA/KIR genes SBT experiment without the BDT v1.1 kits.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable:

A sources sought notice was synopsized on the Federal Business Opportunities (FBO) website on 12 May 2016 and no other sources expressed an interest in this requirement. It is not practicable for the reasons discussed in paragraph 5 above, for any company other than Life Technologies Corporation to perform the required work. Additionally, a notice of intent to sole source was synopsized on the FBO website on 5 July 2016 and no companies submitted a capability statement for this requirement.

7. Determination of Fair and Reasonable Cost:

The Contracting Officer will perform a price analysis in order to determine whether the quote received by the Government for the requirement outlined in this J&A is within fair market value and is reasonable.

8. Actions to Remove Barriers to Future Competition:

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the type of services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.