A01-SSJ_-_Redacted.docx

Control No: JA-19-02-0061

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP)

1. Contracting Activity: The Contracting Activity responsible for this action is the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick MD.

2. Requiring Activity: The Requiring Activity for this action is the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF).

3. Nature of Action:

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

Pricing: |X| Firm-Fixed Price* |_| Time & Materials** |_| Cost* Funds: |X| RDT&E |_| Operations and Maintenance, Army (OMA) |_| Other Funds:

Fiscal Year of Funds: FY19

4. Contractor Name:

Benchmark Products 1605 Waukegan Rd Waukegan, IL 60085

5. Description of Supplies/Services: The PBF operates a large set of cleanrooms for the purpose of manufacturing vaccines and therapeutics that are destined to be administered to human subjects during clinical trials. Specialized materials are needed for the entry and cleaning of rooms that are classified as cleanrooms. The gowning material must be essentially non-particle shedding and must be manufactured to minimize the contamination of the cleanrooms by humans themselves and to minimize any bacterial and particulate shedding from the people working in the cleanrooms. The material must also be easily donned without contaminating the outside of the gowning and must be designed for comfort of human effort without overheating the personnel and causing them to shed particulates. The cleaning materials must be essentially non-particle shedding, must be extremely cleanable themselves while not harboring particles, and must be made of materials efficient in removing particles that are present in the cleanrooms that may be shed during the manufacturing process.

The anticipated Period of Performance (PoP) for this requirement will be one 12-month base period with four 12-month option periods.

6. Authority Cited: |X| 41 U.S.C. 1901 OR |_| 41 U.S.C. 1903 |_| FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR |_| 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| FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR |_| 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:

Coverall, Integrated Hood and Mask (IHAM), and Sleeves - Many commercially available gowning materials are made of Tyvek. Tyvek does not breathe as a fabric and acts as an insulator. This causes elevation of body temperature, which promotes sweating and, subsequently, increases the probability of bacterial and particulate shedding into and contamination of the cleanroom. Because it does not breathe, body movement with Tyvek can act like a bellows to blow air out from inside the gown, also increasing potential for contamination. The SMS fabric provided by Benchmark Products is unique to sterile gowning in that it does not act as an insulator or a bellows. This greatly reduces the possibility of contamination in the cleanroom. There are some other vendors who offer “SMS” fabric, but Benchmark Products fabric is uniquely designed to provide additional tensile strength as well as maximum bacterial filtration efficiency and particle filtration efficiency.

Coverall and Sleeves – Colored donning line on inside of units is unique to Benchmark Products and reduces contamination risk by clearly demonstrating inside vs. outside of the garment. These garments also have a unique thumb loop integrated into the end of the sleeves to ensure that the sleeves stay firmly under the gloves.

Coverall – The garment configuration as provided has a unique “inside-out” fold configuration that allows for a much easier gowning process and thus reduces contamination risk.

IHAM – Benchmark Products offers a unique hood and mask that are sonically welded together. This reduces the chance of contamination through a developing gap which could happen with un-welded units.

Cleanroom Lab Coat - This item is uniquely suitable for ISO Class 7 use within the cleanroom areas.

Nitrile Gloves – Have a 12” length that is longer than most gloves and reduces contamination risk Cleanroom wipes, sponges and mop heads – Material is a proprietary ultra-fiber composition that far exceeds standard microfiber qualities for the ability to get into microcrevices. This material is also able to remove >98% of initial surface bacterial endotoxins with < 0.02% carry-over after reuse. This material is solely manufactured by Benchmark.

Extendable handles for sponges and mops – Designed by benchmark to specifically fit their Suite wipes, sponges and mop heads.

8. Efforts to Obtain Competition:

a. Effective competition. Effective competition is not expected, however a Notice of Intent to Sole Source will be posted on FedBizOpps (FBO) website for all vendors to see in accordance with FAR 5.202. All sources expressing interest and capabilities in response to the notice will receive consideration.

b. Subcontracting competition. No subcontracting competition is expected to exist for this requirement.

9. Actions to remove or overcome barriers to competition: WRAIR will continue to explore alternative options for this requirement.

10. Market Research: WRAIR conducted market research through the System for Award Management (SAM) and on multiple search engines using multiple key terms and criteria specific to this effort. We found no other businesses that were able to meet the PBF requirement. Internet searches were also conducted, including a search of GSA Advantage, to determine if any other vendors were capable of meeting the requirement. Based on the results of the market research, Benchmark was the only vendor identified that could meet the all of the mission essential characteristics needed for this requirement.

11. Interested Sources: To date, no other sources have written to express an interest in this requirement.

12. Procurement History and other facts:

a. Previous Contract or Purchase Order Number: Not applicable

b. Previously Competed? Not applicable

c. Previous authority for less than Full & Open Competition: Not applicable