justification_and_approvalNexseq2_Redacted.pdf

Justification and Approval (J&A) for Other Than Full and Open Competition

[ ]Updated: 15 Mar 16

NOTE: If a Justification and Approval was approved for the preceding acquisition, a copy of the approved J&A for the predecessor action must be included in the staff package for approval of the instant J&A. This applies to J&A staff packages that are submitted for review and approval at a level above the contracting officer. The predecessor J&A will be used as a reference document by the approving official.

Choose the funding level for this J&A Document:

Activity: 10 CONS

Purchase Request / Local ID Number:

Program / Project (and PE, if applicable): NextSeq 500

Program Type (PEO or Other Contracting):

Authority (include full title): 41 U.S.C. 1901, as implemented by FAR 13.501(a)(1)(ii)

Estimated Contract Cost (including options): J&A Type: Class Individual

COORDINATION (AFFARS 5306.304(a) )

Date

Signature

Justification and Approval (J&A) for Other Than Full and Open

[ Updated: 15 Mar 16

I. Contracting Activity.

This justification is executed by the Air Force Medical Operations Office (AFMOA) PMO, Fort Detrick, MD, on behalf of the Lackland Air Force Base Texas Hospital. The contracting agency for this request is 10 CONS/LGCB located at the United States Air Force Academy (USAFA).

II. Nature and/or description of the action being processed.

The action being requested is a sole source acquisition for NextSeq 500 Sequencing System, the Government intends to procure this requirement through other than full and open competition IAW FAR 13.500(a). FAR Parts 12 and 13 procedures will be used and a new firm fixed price contract will be awarded.

III. Description of supplies/services required to meet agency needs.

The NextSeq 500 System is a benchtop whole sequencer with the capacity to sequence an entire human genome at 30x coverage within one run. This analyzer is capable of providing genome wide genotyping as well as gene regulation and gene expression analysis in a cost effective and timely manner. The BaseSpace On-site system is the complementary bioinformatics support system needed to analyze and interpret the results into meaningful data for the researcher. System includes embedded touchscreen monitor and on-instrument computer, NexSeq Control Software, installation, training, and a 12 month warranty.

IV. Statutory authority permitting Other than Full and Open Competition.

41 U.S.C. 1901, as implemented by FAR 13.501(a)(1)(ii)

V. Demonstration that the contractor's unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority).

The NextSeq 500 sequencer is the only product identified that can meet the governments required salient characters:

-- Human Genome Sequencing System capable of sequencing data for up to 120 billion basic pairs in a single run

- The sequencing system shall have the ability to perform genome, exome, and transcriptome sequencing

- Use sequencing-by-synthesis as the core technological operating principle

- Have at least two flow cells

- Include an on-site bio informatics support system for data processing and analysis

- Have the ability to perform at least 2run modes, encompassing base pair reads with ranges including (16-39) gigabases ) (Gb) and (25-120 Gb) capability

- Perform at least 400 million reads per run

- Sequence a human genome in no more than 4 days

- Include an interruptible power supply backup

- All supplied software, operating systems, databases, etc. (excluding vendor developed application software) must be on the National Information Assurance Partnership approved products list found at https://niap-ccevs.org/ or https:// www.commoncriterisportal.org. (This includes embedded software.) Vendor/manufacturer must provide proof that supplied software is on this approved list and must be willing to complete an appropriate information assurance (IA) certification on device. Required proof is a print screen from one of the web sites above for each software component, and a letter of intent form manufacturer to work the IA certification process. This system ensures the Operating system being provided is not expired.

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

A sources sought was posted to FedBizOps on 7 June 2016 with a closing date of 13 June 2016. The intent of the sources sought was twofold, first to determine that the conclusion reached from the initial research was correct and indeed I was the only brand that could meet the requirement. Second was to determine if there were other small business

[ Updated: 15 Mar 16 partnersthat could supply the product. What was discovered is that does not have any small business partnership and or permit third party vendors to represent their products. A search of GSA found no Human Genome Sequencing Systems and a basic Google search returned minimal information about this highly specialized piece of equipment.

IAW FAR 13.501(a)(2) Justifications and approvals are required under this subpart only for sole source (including brandname) acquisitions or portions of an acquisition requiring a brand-name. If the justification is to cover only the portion of the acquisition which is brand-name, then it should so state; the approval level requirements will then only apply to that portion.

(i) For a proposed contract exceeding $150,000, but not exceeding $700,000, the contracting officer’s certification that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief will serve as approval, unless a higher approval level is established in accordance with agency procedures. IAW AFFARS 5306.303-2(a) the approval authority for purchases equal to or less than $700,000 is the Chief of the Contracting Office and is delegable to the contracting Officer, consistent with warrant level. IAW the 10 CONS Mandatory Procedures the 10 CONS Director delegates to all duly appointed contracting officers of 10 CONS the authority to approve J&As not exceeding $700,000, consistent with the level of the individual CO's warrant.

VII. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

Purchase will be made as a Sole Source directly to after determining that there are no active exclusions on sam.gov or Federal Awardee Performance and Integrity Information System (FAPIIS). Supplies offered will be accepted on a fixed price basis. The Contracting Officer will determine the enhancement kits to be priced fair and reasonable in accordance with FAR 13.106-1(b)(2). Since only one response is anticipated the Contracting Officer will utilize Comparison of the proposed price with prices found reasonable on previous purchases to evaluate the quote.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

Market Research for the Genome Sequencing System found that the requirement is commercially available, although technical in nature. Three vendors, were contacted in an effort to locate vendors capable of providing the Genome Sequencing System. I was the only vendor capable of providing the system which can provide the required salient characteristics at this time. is no longer offering a Genome Sequencing System, and the unit sold by requires 15 runs, which is in excess of the one run requirement.. A search of GSA found no Human Genome Sequencing Systems and a sources sought was posted to FBO which resulted in no responses.

The Genome Sequencing Systems are not unique to military medical facilities and are not being modified to meet military requirements. Internet searches were conducted and a sources sought was posted to FedBizOps to confirm no other brand would meet requirements and identify other resellers of human genome systems.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

N/A

X. List of sources, if any, that expressed interest in the acquisition.

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required.

This is a one-time buy which involves the need for a product that is only available from one source. There are no plans at this time to compete future contracts for the type of supply covered by this document. Due to limited availability and market restrictions, options for future awards may also be restricted, however, should another potential source emerge, it will be assessed to determine whether competition is feasible.

[ . ]Updated: 15 Mar 16

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.