M1_WK_JA_16271_Redacted_Redacted.pdf

CONTROL NO.: JA 16271

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 using Simplified Acquisitions Procedures (SAP)

For the Meso Scale Defense (MSD) PR2 1800

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD, 21702.

2. Requiring Activity: U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), 1425 Porter St. Fort Detrick, MD 21702.

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price: x **Time & Materials:

* Cost:

Funds: RDT&E Operations and Maintenance, Army (OMA) Other Funds:

Fiscal Year of Funds: _FY16

Estimated Total Dollar Value including Options: $

4. Contractor Name:

Name of Proposed Contractor(s): Meso Scale Defense.

Street Address: 1601 Research Boulevard City, State, Zip: Rockville, MD 20850 Phone: (240) 314-2795

DUNS: 113033224

Cage Code: 1ZHK4

5. Description of Supplies/Services: The U.S. Army Medical Research Institute of Infectious Diseases (UAMRIID) has a requirement for the purchase of the Meso Scale Defense (MSD) Sector PR2 Model1800. The Special Pathogens Laboratory (SPL) at

USAMRIID provides rapid advanced biological agent identification in support of the war fighter. This cannot be completed unless USAMRIID has the necessary equipment.

Meso Scale Diagnostics is the only manufacturer of the PR2 Model 1800 instrument.

The PR2 Model 1800 has the following characteristics that are essential to the requirement at USAMRIID: ability to measure multiple agents (toxins, viruses and bacteria) from a single sample, electrochemiluminescence (ECL) signal detection technology, plate based immunoassay system capable of 96-well(9, 16, and 25 spot plates), detection electronics - cooled CCD camera, plate read time - 7 minutes, dynamic assay range of 10^5 over the spectrum of assays, temperature operational range 15-30°C minimum, and a system foot print of less than 18 x 18 inches (LxW).

USAMRIID requires one (1) each of the MSD PR2 1800s and their corresponding one

(1) year warranty.

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

X (c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: The vendor is the sole manufacturer with no other sources available in the marketplace to satisfy USAMRIID’s requirement.

8. Efforts to obtain Competition: Market research completed at the USAMRIID and the USAMRAA have indicated that Meso Scale Defense is the sole manufacturer and only supplier of the system with the required capability. Meso Scale Defense does not work with third-party distributors for its Sector PR2 Model 1800 system, and is therefore the only available source for this upgrade requirement. However, in accordance with FAR subpart 5.2, a notice of intent will be posted to FedBizOpps. This announcement will allow for the submission of capability statements from other manufacturers that propose to have a product that can meet the attached MECs to accomplish this requirement. Any responses received will be reviewed for the purpose of determining whether a competitive procurement is in the best interest of the Government.

a. Effective competition. A review of the field of competitive system did not uncover any vendors that assure compatibility for the required instrument and no competition is available.

rtaylor 2016-08-01 15:40:13 use 13.501 instead of 13.106 as over

$150K. RT

b. Subcontracting competition. Not applicable; as this is a supply-type requirement, the Government does not anticipate subcontracting opportunities or competition.

9. Actions to remove or overcome barriers Competition: USAMRIID maintains continuous contact with other researchers and online research is ongoing to locate other manufacturers.

10. Market Survey: The Government technical representative conducted online research for two immunoassay equipment manufactures. On 13 January 2016, Luminex Corporation was contacted and no comparable item was found to meet the requirements. Also on 13 January 2016, the Government technical representative researched the online product catalog for Tetracore and no equivalent item was found to be acceptable. In addition to equipment manufacturers, the Government technical representative also conducted online research for immunoassay equipment distributors.

On 13 January 2016, online catalogs for Fisher Scientific and Life Technologies were examined for immunoassay equipment equivalent to the MSD PR2 1800 and no items were found. The Government technical representative is currently not aware of any other products/suppliers that could satisfy this requirement. Based on the above listed market research, no other sources of supplies exist.

11. Interested Sources: At this time, the Government has not received any notices from interested sources outside of the current suggested source, Meso Scale Defense/MSD.

12. Procurement History and any other facts:

• Procurement History: Exact equipment purchased on previous Award W81XWH-

14-P-0352 awarded a sole source pricing of each for Sector P2 Model 1800 dated 5 September 2014. Pricing for each piece of equipment has remained unchanged, and the vendor has remained consistent in pricing.

• Acquisition Data Availability: An acquisition suitable for full and open competition is not practical for the reasons described in the justification. Any substitute or equal product from an alternative source would not be acceptable for research.

• Unusual and Compelling Urgency: Not Applicable.

• Subcontracting Competition: No subcontracting opportunities exist for this requirement.

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

Submitted by Signature:

Printed name: William R. Dorman Agency/Position/Title: USAMRIID/Research Microbiologist E-Mail Address: William.r.dorman4.civ@mail.mil Date: 29July2016 mailto:William.r.dorman4.civ@mail.mil

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price/ cost to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

Contracting Officer Signature:

Printed name Agency/Position/Title:

E-Mail Address:

Date:

TAYLOR.RICHARD