redactedJA.pdf

CONTROL NUMBER: 080-15

For Official Use Only (See FAR 2.101 and 3.104-4)

(June 2015)

Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: Southern Regional Contracting Office, Carl R. Darnall Army Medical Center (CRDAMC), Fort Hood, TX 76544

2. Description of Action: A Firm Fixed-Priced (FFP) award is anticipated for a follow-on contract. Funds used will be OMA.

3. Description of Supplies/Services: The Carl R. Darnall Army Medical Center (CRDAMC) has a requirement for supplies of thirty (30) APTIMA COMBO2 1000T kits for use with the TIGRIS DTS test system from Gen-Probe. This is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital infections. The delivery schedule is two

(2) kits per month for the first ten (10) months and five (5) kits per month for the last two (2) months for the base year, 1 October 2015 to 30 September 2016, and option year one, 1 October 2016 to 30 September 2017. The APTIMA COMBO2 is for use on the Government leased TIGRIS DTS test system. The total estimated value of this proposed action is approximately $630,000 ($315,000.00 per year each for base and one option year). Both the base year and the option year are subject to the availability of funds.

4. Authority Cited: 10 United States Code § 2304(c)(1) as implemented in Federal Acquisition Regulation (FAR) § 6.302-1 (a)(2)(iii) -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. Reason for Authority Cited: The APTIMA COMBO2 test kits are for use with the TIGRIS DTS test system which is leased by the Government. The test kits are unique and proprietary for use with this system. Procurement will be executed under the authority of 6.302-1 (a)(2)(iii), “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements”, on or before 30 September 2015. Gen-Probe owns the Patents on the APTIMA COMBO2 test kits. The system is patented under one or more of the following patents: 5,514,551, 5,556,771, 5,656,207, 5,658,737, 5,693,468, 5,696,251, 5,723,597, 5,756,709, 5,827,656, 5,840,873, 5,948,899, 6,090,591, 6,893,612, 6,910,720 and 7,172,863. Gen-Probe does not have any authorized distributors of its proprietary blood test kits.

The TIGRIS System is currently in place in the hospital and is compatible and bi-directional with CHCS. It is compliant with the LIS used by the DoD. The College of American Pathologists is the accrediting agency. Accreditation requires validation from two analyzers called side by side validation. Using another system would cause collection of twice as many samples to be tested in two different analyzers or cause the samples to be sent to a local reference laboratory for second testing which would be an additional expense to the Government. Additionally, the space

APTIMA COMBO2 Test Kits from Gen-Probe for the analyzers is limited and installation of a different system would cause an interruption in testing.

6. Efforts to Obtain Competition: A Sources Sought was posted on the Army Single Face to Industry (ASFI) Acquisition Business Web Site from 1 June 2015 through 9 June 2015 in order to maximize efforts to obtain competition. No responses to and no interested vendors responded to that notification.

7. Actions to increase competition: Any future requirements shall be advertised through the Government Point of Entry. When the current Tigris system equipment becomes obsolete or when equivalent equipment becomes available every effort shall be made to increase competition. CRDAMC will continue to evaluate the capabilities of other vendor's products and re-procure Tigris system equipment that provides the best value to the Government. The government will continue to seek new resources that will satisfy these requirements through continued market research, requests for Statements of Capability, and telephonic inquiries.

8. Market Research: The contract specialist conducted market research upon receipt of the requirement in May 2015. Web inquiries revealed Gen-Probe is the proprietary manufacturer and only vendor of the APTIMA COMBO2 test kits for use with the Government leased TIGRIS DTS system. Gen-Probe has no authorized distributors.

9. Interested Sources: To date, no other interested parties responded to the Sources Sought Notification or expressed an interest in this requirement. The notices required by FAR § 5.201 shall be published and that any bids or proposals received shall be considered.

10. Other Facts:

a. Procurement history.

(1) Previous procurements include W81K00-14-P-0930, 1 Oct 2014 – 30 September 2015 for $504,000.00.

(2) A Sources Sought was posted from 29 July 2014 through 4 August 2014. The results of the posting were no interested parties responding and the acquisition was procured as a sole source.

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.

fffffffffffffffffffffffffffffffffff Signature: _________________________ Date: ______________________ Name: Gloria Iosefo Title: Supervisor, Microbiology

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.

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Name: Gloria Iosefo Title: Supervisor, Microbiology

13. Fair and Reasonable Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. Certified cost and pricing data is not required IAW 15.403-1(b)(3).

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Name: JACQUELYN A. JOHNSON Title: CONTRACTING OFFICER

14. Contracting Officer Approval: Based on the foregoing, I approve the procurement of the APTIMA COMBO2 test kits for use in the Government leased TIGRIS DTS system on an other than full and open competition basis pursuant to the authority of 10 United States Code § 2304(c)(1) as implemented by FAR § 6.302-1 (a)(2)(iii) -- "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements" subject to availability of funds, and provided that the items for purchase herein described have otherwise been authorized for acquisition.

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

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Name: JACQUELYN A. JOHNSON Title: CONTRACTING OFFICER fffffffffffffffffffffffffffffffffff