SSJ_redacted.oxps

Control No: JA-Edg-17-679 Contractor: Meso Scale Defense Program/Equipment:

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment:

To support the analysis of environmental samples for biological agents, ECBC is procuring assay test kits for its MSD ECL detector.

Authority:

Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Amount:

$1,609,999 Prepared by:

Je’Neane Solomon DSN: 867-0966 Contract Specialist Date: 10 July 2017 Email: Jeneane.o.solomon2.civ@mail.mil Contracting Officer:

Jemel Hogan DSN: 584-4476 Contracting Officer Date: 10 July 2017 Email: jemel.m.hogan.civ@mail.mil Technical:

Crystal Harris DSN: 584-5669 Biologist Date: 5 July 2017 Email: crystal.l.harris1.civ@mail.mil Requirements:

John Barczak DSN: 867-2778 Biologist Date: 5 July 2017 Email: john.m.barczak.civ@mail.mil Reviews:

I have reviewed this justification and find it adequate to support sole source.

Program Manager:

Name: Jerry Pfarr

DSN: 584-9430

Signature: Date:

Legal Counsel:

Name: Dylan Bush

DSN: 584-1266

Signature: Date:

Version – March 2016 FOR OFFICIAL USE ONLY

Program/Equipment:

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval Special Advocate for Competition:

SeefinalpageforSCA approval.

Contracting Activity:

U.S. Army Contracting Command – Aberdeen Proving Ground, Edgewood Contracting Division, ATTN: CCAP-SCE, Aberdeen Proving Ground, MD 21010- 2.Description of Action:

Edgewood Chemical Biological Center’s (ECBC) requests a firm-fixed-price contract with Meso Scale Defense (MSD). The Government projects award for September 2017 and fiscal year 2017, RDT&E funds will be used.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

3.Description of Supplies:

ECBC Environmental BioMonitoring Laboratory (EBML)has a requirement for delivery of 285 MSD custom biological kits for a range of target agents including: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Vaccinia virus, Brucella sp., Coxiella burnetti, Staphylococcal enterotoxin B, Ebola virus, Botulinum A/B toxin, Ricin, Abrin, Venezuelan Equine Encephalitis (VEE), shiga-like toxin 1 and shiga-like toxin 2. The Contractor shall also develop and deliver a new assay for Burkholderia.

The items contained in this purchase request are assays that, when analyzed on specialized equipment, are used for the detection of biological agents. The kits contain assay plates in a 96 well format. Each well contains 9 “spots”: one or more spots contain antibody against a specific agent (capture antibody), one serves as a negative control, and one as a positive control. Liquid reagents included in the kit are:

1.Detector antibody, positive control antibody, positive control antigen, and antibody diluent which are combined to form a “working stock” 2.Read buffer which is used to activate the chemical reaction that occurs as a result of the working stock interaction with the plate and the sample being tested.

Estimated value for this acquisition is $1,609,769.00. No options will be included in this award.

The estimated delivery of supplies will be not later than 365 days after award.

4.Authority Cited:

Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5:

5.Reason for Authority Cited:

(a) The proposed acquisition must be accomplished through a sole source solution because these products are unique and are only available from one source, which is Meso Scale Defense (a division of Meso Scale Diagnostics, LLC). Meso Scale Defense is the manufacturer of the MSD custom biological kits for target agents (bacteria, viruses and toxins) and they do not have any

Program/Equipment:

distributors, resellers or authorized partners. RDECOM’s ECBC EML requires these reagents to detect biological warfare agents using electrochemiluminescent (ECL) technology.

MSD ECL test kits are specifically designed to be used in conjunction with the MSD PR21800 instrument, which ECBC’s laboratory currently owns. The required test kits are customized products which are designed, approved and validated by both the MSD Laboratory and Environmental Bio-Monitoring Lab (EBML). The MSD test kits have been rigorously tested using standards set by ISO17025 and the Joint Program Executive Office Quality Program (JPEOQP) under which the EBML operates. The required test kits utilize MSD’s propriety multiplexed ECL technology and fulfills the sensitivity, specificity, and throughput capacity needed for our clients. There are no other suppliers that provide products that incorporate the technology to allow the processing of samples as rapidly and accurately as the MSD platform.

MSD owns a number of patents covering the manufacturing of instruments and test kits. MSD has exclusive, permanent and irrevocable license to the fundamental patent portfolio for the ECL technology.

(b) Alternatives: There are no alternatives to the MSD ECL test kits due to the fact that they are of a proprietary fit and function specific to the MSD PR2 1800 ECL detector. The procurement of a different platform for ECL testing of biological agents would require that this same level of testing be duplicated, costing approximately $1.5 million dollars and three years to complete.

Generating comparable statistical data would take an additional $2 million dollars and no less than three (3) years of testing and data analysis. These figures are an approximation based on the amount of labor hours and materials that went into research for the development of these assays, the validation and demonstration of capability of the assays, and the incorporation of the technology into the client’s concept of operations. Additionally, the statistical confidence of the assays is based on the number of samples (unknowns and quality assurance samples) which is of paramount importance to the clients. This would also mean a decrease in confidence of EBML and a decrease in client work for the Government.

(c) Additional Facts:

(1) The verified minimum requirement of the Government is 285 EA test kits for MSD PR2 1800. Current supplies will not last through the end of FY17. This procurement will satisfy the Government’s need through FY18.

2) Competition is not feasible, even if more time were available. No other manufacturer or distributor sells biological agent test kits for MSD PR2 1800 ECL detectors.

3) This requirement was generated within ECBC, not directed or mandated by a higher level. The test kits are needed to provide support to ECBC clients.

4) The design of the PR2 1800 ECL detector and the test kits are proprietary.

5) The requirement is not for an interim contract.

6) The test kits are used to ensure a safe work environment for scientists and technicians across ECBC that have the potential for exposure to biological agents. Without these test kits, a wide range of operations across ECBC would need to halt. Not obtaining this requirement for

Program/Equipment:

MSD test kits will result in the failure to provide a high-level client with validated laboratory capabilities. This client has built a new testing facility that ECBC has outfitted with analytical equipment and reagents. This classified mission provides an important national security function, and a delay in providing these services will have a detrimental effect on national security.

6.Efforts to Obtain Competition:

Notices of Intent to award sole source contracts have been posted to FEDBIZOPPs in 2012, 2013, 2014, 2015, and 2016 without response from interested contractors. Market research is continually being conducted. The Contracting Officer shall publish the notices required by FAR 5.201.

7.Actions to Increase Competition:

When ECBC undergoes new development of ECL assays, new sources will be evaluated other than Meso Scale Defense in an effort to increase competition in the future. This will be accomplished by performing a market survey in advance of designing new protocols and equipment recommendations, by identifying several choices that could be used for process development, and then competing for best value equipment. However, to date, the ECBC subject matter experts have found no other manufacturers who have developed comparable ECL assays and MSD has proprietary technology that cannot be duplicated.

8.Market Research:

Market research is being conducted continuously by EBML biologists and scientists at the Department of Homeland Security (DHS). Monthly research and development telecons take place to discuss new and upcoming technologies. Currently The MAGPIX platform (Luminex Corp.) is the only comparable platform to the PR21800 in use. However commercially available assays for the MAGPIX are not available for our target compounds. Development of assays for the MAGPIX would require customization and optimization. This would require significant time, money, labor, new methods, and validation. It would also require restarting the ECL program from scratch.

9.Interested Sources:

An extensive procurement history is listed below. Pre-solicitation notices have been posted regularly and rarely do any other sources write to express interest in the acquisition. Bruker, a large business, expressed interest in the FY15 solicitation, however technical evaluation revealed they did not meet the necessary requirements. The reason being that Bruker’s additional sample preparation steps involved in the Bruker ELISA method would increase our analysis time and they do not currently have assays for all of our targets. The Bruker can process 6 bio agents within 20 minutes, but the MSD system we already have can process 15 bio agents within 20 minutes. Since we may test for as many as 15 unique bio threats in response to an exposure event, the Bruker would take three times longer to get results, wasting critical response time. Additionally, switching to the Bruker would require the development of new assays specific to their system.

10.Other Facts:

a. Procurement History:

Contract: W91ZLK-16-P-0275 Contractor: Meso Scale Defense Award Date: 09/24/2016 Dollar Value: $432,116.00 Competitive status: Not competed

Program/Equipment:

Authority: 41 U.S.C. 1901 as implemented by FAR Subpart 13.5 Contract: W91ZLK-16-P-0072 Contractor: Meso Scale Defense Award Date: 04/06/2016 Dollar Value: $432,116.00 Competitive status: Not competed.

Authority: 41 U.S.C. 1901 as implemented by FAR Subpart 13.5 Contract: W91ZLK-15-P-0500 Contractor: Meso Scale Defense Award Date: 9/2016 DollarValue:$843,072.00 Competitive Status: Not competed.

Authority: 41 U.S.C. 1901 as implemented by FAR Subpart 13.5 Contract: W91ZLK-14-P-0399 Contractor: Meso Scale Defense Award Date: 7/2014 DollarValue:$786,816.00 Competitive Status: Not competed.

Authority: 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Contract: W91ZLK-14-P-0061 Contractor: Meso Scale Defense Award Date: 1/2014 DollarValue:$142,964.00 Competitive Status: Not competed.

Authority: 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Contract: W91ZLK-13-P-0505 Contractor: Meso Scale Defense Award Date: 8/2013 DollarValue:$442,484.00 Competitive Status: Not competed.

Authority: 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Contract: W91ZLK-13-P-0098 Contractor: Meso Scale Defense Award Date: 3/2013 Competitive Status: Not competed.

DollarValue:$24,000.00 Award Date: 1/2014 Competitive Status: Not competed.

Authority: 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Contract: W91ZLK-13-P-0208 Contractor: Meso Scale Defense Award Date: 03/14/2013 Dollar Value: $799,252.00 Competitive status: Not competed.

Authority: 41 U.S.C. 1901 as implemented by FAR Subpart 13.5

Program/Equipment:

Contract: W91ZLK-12-C-0015 Contractor: Meso Scale Defense Award Date: 05/07/2012 Dollar Value: $419,828.00 Competitive status: Not competed.

Authority: 41 U.S.C. 1901 as implemented by FAR Subpart 13.5

Program/Equipment:

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.

Date: ______________ ____________________________ Crystal Harris Biologist 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.

Date: ______________ ____________________________ John Barczak Biologist Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. This determination will be made using comparison to the Independent Government Cost Estimate (IGCE), market research, and similar procurement history. As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial. The Government will seek a discount from the contractor prior to award’.

AlexM.Schupp, for Jemel Hogan Date:

13Sept2017 Contracting Officer

Signature:

14.Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

AlexM.Schupp, for 13Sept2017 Jemel Hogan Date:

Contracting Officer Signature:

Program/Equipment:

Approval Based on the foregoing justification, I hereby approve the procurement of biological agent kitson a sole source basis pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.If the proposed contract action is not completed within 180 days from the date below or if there is a change to the substance of this J&A that does not meet the AFARS 5106.303-1-90 conditions for an amended J&A, the Contracting Officer shall document these changes in a memorandum for file and obtain revalidation from the approval authority below.

14Sep Dennis Longo Date:

Special Advocate for Competition Signature: