FBO_JA-_Fluid_Mass.pdf

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

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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:

< $700K > $700K and < $13.5M > $13.5M and < $93M > $93M

Contracting Activity: 10 CONS

Purchase Request / Local ID Number: F1ATB27074AW02

Program / Project (and PE, if applicable): Fluid Mass Spectrometer

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

11 Sep 2017

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I. Contracting Activity.

This justification is executed by the Air Force Medical Operations Office (AFMOA) PMO, Fort Detrick, MD, on behalf of Wright Patterson AFB. The contracting agency for this request is 10 CONS/PKB located at the United States Air Force Academy

(USAFA).

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

The proposed action is to acquire one Shimadzu Nexera Supercritical fluid extraction (SFE)/supercritical fluid chromatography (SFC) with Liquid Chromatography Mass Spectrometer (LCMS)-8050 Unified Chromatography and Accessories as a Brand Name Only requirement. Spectrometers are a common tool used by scientists to determine information about an object, or substances through the analysis of its light properties.

The use of so-called ‘supercritical’ carbon dioxide for extraction and chromatographic separation is not a new approach, yet interest in this alternative technique is growing with the advance of state-of-the-art equipment and a steadily increasing amount of research and publications on the subject. Highly complex samples originating in the clinical field, natural product research, food or environmental control facilities and academic institutes, challenge analytical researchers who are always striving to improve separation techniques and simplify sample pretreatment. The use of ‘supercritical’ CO2 for both extraction and chromatographic separation can offer exactly that, more efficient extraction processes combined with shorter analytical run times, while simultaneously reducing solvent consumption. Furthermore, extraction selectivity can be carefully controlled by tuning the solvating power of the CO2 through changes in pressure and temperature, making it faster, more efficient and more versatile than liquid extractions .

The Shimadzu Nexera SFE/SFC with LCMS-8050 Unified Chromatography improves laboratory work-flow by uniting sample extraction, separation and detection into a single analytical platform. Target compounds are automatically extracted by SFE and transferred to SFC-tandem mass spectrometer for Tandem Mass Spectrometry (MS/MS) so that no human intervention is required. This reduces the time to process samples from hours to minutes. The extraction and separation steps are processed with supercritical carbon dioxide which nearly eliminates the need for harmful and expensive solvents. The use of CO2 also protects labile compounds that may be oxidized or degraded by extraction solvents. The equipment will be used at Wright Patterson AFB for the 711th Human Performance Wing.

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

Equipment required is as follows:

Nexera UC-SFC- No Detector

220-91619-05 Nexera UC SFC System-No Detector 228-61493-41 Piping kit, MS, SFC 228-45137-42 LC-20ADXR HPLC Pump 228-45162-42 Nexera LC-30AD HPLC Pump 228-62767-41 Piping kit, LC/SFC Switching 228-45205-58 Nexera LC-30AD low volume LPGE Unit with 40uL Mixer 228-61492-41 Piping kit, basic, SFC 228-45164-42 Nexera Rack Changer II (ROHS-compliant) 228-45219-42 Supercritical fluid extraction unit, SFE-30A 228-61097-44 Rack changer-compatible extraction vessel L (5.0mL) Start kit, RC II, SFC/SFE 228-61315-41 Funnel Set, SFE-30A 228-61137-00 Dehydrator hydro-P, SFE-30A 228-45218-42 Supercritical Fluid back pressure control unit SFC-30A

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228-58081-81 Extraction vessel L (5.0mL), SFE, rack 228-58648-42 Sample rack for rack changer 5 mL, rack changer II, SFC/SFE 220-99999-C4 Valco Diverter Kit: C2-1006EH

LCMS-8050

220-91597-01 LCMS-8050 package 220-91600-52 LCMS-8045/8050/8060 Installation kit 225-19605-58 DUIS dual probe set for LCMS-8045/8050/8060 225-97823-11 UPS 4.0kVa, for GCMS and LCMS-SQ/TQ only, ABCDEF4000-22 220-99999-C4 N34M Laboratory nitrogen generator 220-91237-01 Rough pump stand, LCMS, for Edwards 28/30 220-97321 Dell 24" wide-screen flat panel I&F 3 Day 3 Day installation and customer familiarization 1YW 1 year warranty

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

41 U.S.C. 1903, 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).

There are other manufacturers who produce supercritical fluid extraction (SFE) and supercritical fluid chromatography (SFC).

However, Shimadzu is the only manufacturer of a combined SFE/SFC system that can be interfaced into MS/MS data collection.

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

Market Research revealed that the Shimadzu Nexera SFE/SFC with LCMS-8050 Unified Chromatography, are a commercially available product. They are sold in substantial quantities in the commercial market place.

A basic Google search of Shimadzu Nexera SFE/SFC with LCMS-8050 Unified Chromatography found several listings for the product but little information about specific vendors offering the product.

A sources sought was posted to FedBizOps as a name brand or equal requirement on 14 April 2017, with a closing date of 21 April 2017 and one vendor responded offering the Name Brand item.

The one response received was from SCG Business Services, LLC, a self-certified small business. They indicated they are capable of providing the name brand requirement and are an authorized reseller of the Shimadzu Nexera SFE/SFC with LCMS-8050 Unified Chromatography. They also provided a brief capability statement which addressed the companies background, capabilities and past performance.

Mr. Phil Martin, the Point of Contact for Shimadzu (the manufacturer) was contacted and he indicted they are able to directly sell the Nexera SFE/SFC with LCMS-8050 Unified Chromatography. They also indicated that they have one preferred (Vision Financial) reseller, and are willing to work with additional retailers.

A known small business medical equipment provider, Strategic Initial Outfitting Transition Solutions LLC (SIOTS), was reached via email and asked if they were capable and interested in quoting on this requirement. A response was received from Ms. Emily Toussaint indicating that they were capable and interested.

Additionally, no vendor responded with a like item, which reinforced the conclusion that this requirement is a Name Brand Only requirement.

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

The offer will be evaluated IAW FAR 52.212-2 Evaluation- Commercial Items (Oct 2014). BASIS FOR CONTRACT AWARD: This will be a competitive acquisition in accordance with FAR Parts 12 and 13. Price fair and reasonable will be determined as follows:

Price Evaluation. IAW FAR 13.106-3(a)(1)- price reasonableness will be based on competitive quotations, or offers.

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

Market research indicated the Shimadzu products were the only pieces of equipment capable of meeting the salient characteristics provided by the end user. In an effort to ensure this information was accurate, a Sources Sought was posted and one vendor replied offering the Brand Name product. The sources sought was followed up with a phone call to the manufacturer who indicated that they had the capability to retail the equipment themselves and had one preferred business retail partner. They also indicated that they were willing to work with additional retailers that may be interested in distributing their product.

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.

Shimadzu (the manufacturer), Strategic Initial Outfitting Transition Solutions (SIOTS) and SCG Business Services, LLC.

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 manufacturer. 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.

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.

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