J A_Redacted.pdf

J&A Number: 16-10178

JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN

COMPETITION

l. 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.

Award of a firm fixed price contract on a sole source basis for AMPure and CleanSEQ reagents in support of The Department of Defense (DoD) Bone Marrow Program for NMRC. The . u .

proposed source is Beckman Coulter, 2301 E 60 1 Street N, Sioux Falls, SD 57104. .

3. Description of Supplies/Services.

The purpose of this acquisition is to provide reagents for the DoD Bone Marrow Program's DNA analysis requirements. The DoD requires reagents that must have no centrifugation or filtration steps to maintain manual or fully automated performance for high throughput which minimizes typing costs without compromising the high quality sequence data results. The reagents must be able to accommodate various fluorescent dye sets and must be optimized for use with electrokinetic injection on capillary electrophoresis systems of 3 730 DNA Analyzers which are cunently in use by the DoD Bone Manow Program. These reagents must function in existing Beckman liquid handling robotic systems with existing software and must not require re certification by the Bone Marrow Program's laboratory or the American Society for Histocompatibility and Immunogenetics (ASHI) and Department of Health and Human Services (HHS) required certification for laboratory procedures. It is critical to maintain the cunently certified laboratory process for consistent testing results and ASHI and HHS accreditation and maintain the ability to Human Leukocyte Antigen (HLA) type and register DoD volunteer donors within the DoD and National Marrow Donor Program as potential donors of marrow for clinical transplantation.

The Department of Defense Bone Marrow Program undergoes a rigorous accreditation process through ASHI (American Society of Histocompatibility and Immunogenetics) in order to remain in compliance. The ASHI certification provides accreditation required by the Department of Health and Human Services, Centers for Medicare and Medicare Services (CMS) that is the federal certifying body for these complex clinical laboratory procedures (HLA testing). The certification is required to use HLA test data for marrow transplants on behalf of patients or casualties and is required by the National Marrow Donor Program and Department of Health and Human Services for submission of HLA data in the NMDP data file for transplant centers searching the NMDP file for donors for marrow transplant patients. Without the certification, the laboratory efforts of the NMRC laboratory for clinical HLA testing would be closed, the DoD Marrow Donor Program would be unable to perform these necessary functions and patient and casualty access to donors to save their lives would be seriously compromised. Every procedure used for l-ILA testing for clinical purposes must be certified by the performing laboratory and these tests must function properly in laboratory extemal proficiency tests -performed by ASHI cettified test systems ("blind testing" through an external proficiency test program) and by the NMDP quality analysis program.

The certification process for these reagents (AMPure and CleanSEQ) take months to complete and must be constantly maintained. Any change in procedure would need to first be tested by this laboratory for effectiveness and ce1tified that it resulted in extremely high quality data required for clinical competence, by NMDP and by ASHI for the Department of Health and Human Services.

In order to meet high throughput, high accuracy and low cost, the laboratory incorporated automated liquid handling systems manufactured by Beckman. These are highly sophisticated systems able to precisely perform reagent transfers at extremely low liquid volumes. As part of this high precision process, Beckman incorporated the AMPure and CleanSEQ process in their robotic systems as these products both perform very effectively in the genetics (HLA) analysis systems, and because these reagents are able to operate within the mechanical capabilities and requirements of the robotic system.

Beckman devel~ped and provides-custom software for operation of the Beckman robotic instruments used by the laboratory for specific use with the AMPure and CleanSEQ reagents.

AMPure is a certified reagent by tht Department' of Defertse Bone M~now Program as per ASHI accreditation standards and is' used to putifY PCR product to remove excess primers and dNTPs before sequencing reaction. CleapSEQ ·has been certified by the Bone MaiTow Program over the years as per ASHI accreditation and is applied to purify sequencing product following the sequencing reaction. The Bone Marrow Program has certified per ASHI accreditation standards that the AMPure and CleanSEQ reagents meet quality standards required by the program for consistent high quality HLA test results and this certification has been accepted by ASHI and subsequently the Department of Health and Human Services CMS for clinical laboratory testing certification. As required by this laboratory, National Marrow Donor Program and clinical transplant programs for certification, these reagents perform extremely well and consistently in the laboratory and in the robotic liquid handling system and produces consistent high quality data. This high quality test sample preparatory procedures including CleanSEQ and AMPure are required for use in the completion of the HLA test procedures (Applied Biosystems 3730 DNA Analyzer) and DNA sequence data analysis to interpret DNA sequencing data and the subsequent interpretation of this laboratory sequence data to the highly complex l-ILA types required for matching DoD volunteer donors with potential patients or casualties for clinical transplantation.

In the robotic systems and automated DNA analysis, AMPure and CleanSEQ provide the necessary high recovery of DNA test material (amplicons) and provide a level of efficiency of removal of unincorporated dNTPs, primers, primer dimers, salts and other contaminants providing proven high quality data results. Beckman Coulter is the only manufacturer and distributor of AMPure and CleanSEQ reagents; the reagents have been certified by Department of Defense Bone Marrow Program as per ASHI accreditation to work with existing 3730 DNA Analyzers which is necessary to keep consistent testing results for the Bone Marrow Program.

Change to any other reagent purification system would require evaluation of any other system for quality of data and efficiency in an application using extremely small volumes of materials (microliters) required for cost effective operation; other systems would not be compatible with the existing laboratory procedures including the precision robotic liquid handling systems and software; and would require closing the clinical testing by this laboratory during these extensive revisions as this process would result in loss of laboratory certification. Entirely new certification would need to be completed following thorough evaluation both by the laboratory and by the certifying agencies. This would lead to loss of new donor registration by the DoD Marrow Donor Program, potential loss of lives of patients who depend on the availability of these donors, extensive evaluations of any new replacement product, laboratory changes to accommodate a new reagent product and recertification. Costs of laboratory evaluation of new reagent products, laboratory modifications and laboratory recertification would by far exceed the cost of the entire purchase price of these reagents.

4. Statutory Authority Permitting Other Than Full and Open Competition.

10 USC 2304(c)(l) (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.

Beckman Coulter has been identified as the only responsible source that can provide the required reagents, in accordance with FAR 6.302-1. The patented AMPure and CleanSEQ purification systems have been applied to the DoD Bone, Marrow Program's HLA typing systems through the 3 730 DNA Analyzers for more than 10 years in line with ASHI accreditation standards. Market research including internet searches and information provided by subject matter experts concluded that there are no other reagents that can be used with these DNA analyzer systems.

According to subject matter experts at the DoD Bone Marrow Program for NMRC, AMPure and CleanSEQ are the only certified reagents by the Marrow Program as per ASHI and HHS accreditation standards. Therefore, because Beckman Coulter is the only manufacturer and distributor of AMPure and CleanSEQ reagents, they represent the only responsible source available to purchase from.

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 8 July 2016 and no other sources expressed an interest in this requirement. Additionally, a notice of intent to sole source will be synopsized on the FBO website. It is not practicable for the reasons discussed in paragraph 5 above, for any company other than Beckman Coulter to provide the required items. In the unlikely event that another company submits a written interest in this requirement as a result of the notice of intent to sole source, the company's information will be evaluated before a contract is awarded to Beckman Coulter.

7. Determination of Fair and Reasonable Price.

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.

NMLC has attempted to reach out to other vendors with regard to this requirement. Before awarding the previous contract (N62645-14-P-2089) a synopsis was posted to the FBO website and no companies responded. A sources sought notice was also synopsized on the FBO website on 8 July 2016 and no other sources expressed an interest in the requirement. For those reasons set forth in Paragraph 5, NMLC has no plans at this time to compe~e future contracts for the types of services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.

9. Contracting Point Of Contact~