SSJ Final_Redacted.pdf

Control No: JA-20-04-0309

Contractor: Edge Biosystems, Inc.

Program/Equipment: Performa DTR Ultra 96-Well Plates

Version –March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS

SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment

Edge Biosystems, Inc. will provide their performa Dye Terminator Removal (DTR) Ultra 96-Well plate kits for use in the purification of BigDye Sanger Sequenced DNA products.

Authority

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

Amount:

Prepared by: DSN

Date: 02/25/2020

Contracting Officer: DSN

Date: 02/25/2020

Technical: DSN

Date: 03/25/2020

Requirements: DSN

Date:

Reviews

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

Program Manager:

AFMES

Legal Counsel:

Acquisition Attorney

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items

Sole Source Justification and Approval

1. Contracting Activity

The Contracting activity for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820

Chandler Street, Fort Detrick, MD 21702-5014 in support of the Armed Forces Medical Examiner System’s – DoD

DNA Operations (AFMES-DNA Ops).

2. Description of Action

The requiring activity for this action is the Defense Health Agency (DHA), Armed Forces Medical Examiner System

(AFMES), which requests a firm fixed price 5-year Blanket Purchase Agreement (BPA) for the purchase of Brand

Name only Edge Biosystems, Inc. performa Dye Terminator Removal (DTR) Ultra 96-Well plate kits from Edge

Biosystems, Inc. and Fisher Scientific is the only authorized reseller. The AFMES-DNA Ops core mission is to assist with recent death investigations of military and civilian personnel lost in training mishaps, conflicts, and war; and the

Defense POW/MIA Accounting Agency (DPAA) with past accounting of military and civilian personnel lost during

World War II, the Korean War, Vietnam and the Cold War.

The Government projects award for July 2020 and fiscal year 2020. The funds will be obligated by issuance of delivery order(s) using Defense Health Program, Operations Maintenance Army funds, and/or Military

Interdepartmental Purchase Request (MIPR).

When applicable and if known, address the estimated share and ceiling arrangements, and fee or profit. Additionally, choose the appropriate statement below:

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).

NOTE: This action is a follow-on to contract . That contract was not competed under authority

10 U.S.C. 2304(c) (1). The FAR citation is 6.302-1 and the FAR citation title is Only One Responsible Source and

No Other Supplies or Services will satisfy the Agency Requirements.

There is only one source (Edge Biosystems Inc.) that provides products that incorporate our current validated sequencing procedures with the Applied Biosystems 3730 and 3500 Genetic Analyzers. The use of any other manufacturer’s reagents requires various validation procedures involving a significant cost to the government, a significant number of man-hours and effort lasting approximately 6 to 12 months, during which time the normal daily operation of mitochondrial DNA testing for the identification of US service members will be suspended.

Mitochondrial DNA testing is required and supports over 93% of all new identifications produced by the Defense

POW/MIA Accounting Agency (DPAA) in meeting and maintaining the NDAA 2010 mandate of supporting over

200 new identifications every year. The approved justification for 5 awarded on 8 Sept 2017 will accompany the current requirement.

3. Description of Supplies/Services

The required Brand Name Only reagents and supplies are used to support the AFMES and the Defense POW/MIA

Accounting Agency (DPAA) with human remains DNA testing for the identification of U.S. Service members as mandated under title 10 USC, chapter 75, 1471 and 10 USC, Chapter 76, 1501-1513; NDAA 2010, Section 541

(d)(2) and DODI 5154.30. AFMES–DNA Operations requires reagents and supplies that provide optimal performance for the purification and filtration of dye terminators in sequencing chemistry (a necessary procedure used in DNA identification). In order to accomplish the proper purification and filtration, it is necessary to utilize a

96-well plate system, consisting of plates with columns in a standardized array, packed with a gel matrix optimized to effectively remove dye terminators, dNTPs, salts and other low molecular weight materials from sequencing reactions. The Brand Name Performa DTR Ultra 96-Well Plates remove DNA primers and fragments up to 15 bases, buffers, nucleotides labeled with biotin, isotopes and other assorted markers. Furthermore, the plates are pre-packed with a fully hydrated matrix to afford optimal handling and performance characteristics. To minimize the potential for interference with sequencing applications, no preservatives, salts or buffers are used in the preparation of these columns. Both ends of the plates are sealed to prevent drying and they require no refrigeration for storage. During proof of concept and development of the methods for amplification and sequencing strategies, the DTR Ultra 96-Well

Plates (manufactured by Edge Biosystems Inc.) were proven by the government to be: reproducible from lot to lot;

robust; reliable; and free from human nuclear and mitochondrial DNA contamination. Vendors that produce

Program/Equipment: Performa DTR Ultra 96-Well Plates

Version –March 2017 FOR OFFICIAL USE ONLY contamination free, reproducible and reliable reagents are essential for processing forensic casework samples and meeting AFMES-DNA Ops mission requirements. Development, optimization and validation of the amplification and mitochondrial sequencing methodologies used to identify missing individuals were performed using the Performa

DTR Ultra 96-Well Plates according to the ISO-17025 and FBI-QAS standards. The Performa DTR Ultra 96-Well

Plates have been validated and in use since 2003 and the AFMES-DNA Ops requires sustained ability to purchase these plates for ongoing mission requirements.

The use of the Edge DTR plates to purify sequence samples has allowed AFMES-DNA Ops to establish a high throughput sequencing process that allows for more than 8,000 sequencing reactions per month to be performed.

These plates have substantially increased AFMES-DNA Ops’s support of the past accounting mission and are needed so AFMES-DNA Ops can continue to support the AFMES and DPAA.

The AFMES-DNA Ops is an ANSI National Accreditation Board (ANAB) ISO-17025 and FBI-QAS accredited forensic laboratory that provides mission essential services for a number of Agencies, including the Federal Bureau of Investigation (FBI), National Institute of Standards and Technology (NIST), the United States Army Criminal

Investigations Laboratory (USACIL) and DoD agencies. AFMES-DNA Ops is a global leader who provides leadership in consultation, education, and research in the fields of human identification, forensic analytical services, bioinformatics, and human reference specimen collection. These reagents are needed to augment current identification methods and will increase the knowledge and success rates of the forensic community as a whole.

The estimated base price is . The total five (5) year estimated price is 0.

Period of Performance: _1 Aug 2020_ to _31 July 2025_

4. Authority Cited

Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency

Procurement) as implemented by FAR Subpart 13.5:

Other: The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)

(1). The FAR citation is 13.501 (A)(1)(i) is Only One Responsible Source (including Brand Name only requirements).

5. Reason for Authority Cited

In 2003 and through continued assessment of competitor’s alternative products, Edge Biosystems Inc. Brand Name

DTR Ultra 96-Well Plates continue to be verified by the government as reproducible, robust and free from human mitochondrial and nuclear DNA contamination. Vendor’s that produce contamination free, reproducible and reliable reagents are essential for to meet AFMES-DNA Ops’s mission requirements of performing DNA testing on highly degraded human remains from World War II, Korea, Vietnam and the Cold War. AFMES-DNA Ops completed the forensic validation of their amplification and sequencing strategies with the Edge Biosystems Inc. DTR Ultra 96-Well

Plates in 2003. The validation experiments were done in accordance with the Federal Bureau of Investigations

Quality Assurance (FBI-QAS) and the International Standards Organization (ISO) 17025 DNA forensic laboratory accreditation standards. Alterations to any reagent or kit that has been validated for use with this amplification and sequencing method will prevent the identification of missing individuals for at least 24-36 months, while new developmental testing and validations are performed to replace the Edge Biosystems Inc. DTR Ultra 96-Well Plates.

The need to first verify that alternative plates do not affect the reproducibility, reliability or increase the chance for contamination and then forensically revalidate the amplification and sequencing method will cost the government a significant amount of money to include two full time CME’s and undetermined amounts of reagents and consumables.

Development, validation and implementation of customized kits for the identification of deceased and/or missing military individuals has been completed; alternative competitors’ kits would significantly delay the use of this procedure and cost the government additional money as the laboratory would be required to pretest, re-optimize, and forensically validate the method with different chemicals. The downtime of an alternative plate in lost man-hours plus the additional expense of training staff and going through re-validations would cost the Government in excess of

$1,500,000.00. It is not in the best interest of the Government to compete and lose the amount of man-hours in training and re-validating of the customized kits that have already been invested.

6. Efforts to Obtain Competition

Program/Equipment: Performa DTR Ultra 96-Well Plates

Version –March 2017 FOR OFFICIAL USE ONLY

The Government will continue monitoring the market and assess and feasible alternatives. Currently however, there is only one Brand Name source capable of providing the solution, given the nature of the mission and the need to ensure consistency and validity of the DNA test results, Edge Biosystems Inc. Brand Name Only DTR Ultra 96-Well

Plates were previously tested against other systems and these plates generated results that were reproducible, robust and free from human mitochondrial and nuclear DNA contamination when compared to competitor’s kits.

The Contracting Officer shall publish the notices required by FAR 5.201.

7. Actions to Increase Competition

None. Because of the nature of the work performed at AFMES-DOD DNA Ops, using any other brand or substitute consumable would compromise the validity of future tests. Edge Biosystems, Inc. and any Edge Biosystems authorized reseller are the only companies that provide this consumable.

8. Market Research

Market Research was completed in March – April 2020 timeframe. In addition, prior to the decision to implement and forensically validate a DNA testing method or product for use in human remains testing, the AFMES-DNA Ops section performs extensive product comparison and optimization studies to identify the most robust and reliable products and methods. Reagents and consumables are compared and tested for sensitivity, ease of use, consistency, cost, and compatibility with the existing instrumentation used in the laboratory. Then the best products for human remains DNA testing are validated according to accredited guidelines. Although similar products are on the market, they do not provide the same benefits from the recommended products that incorporate our current validated sequencing procedures. The Millipore Montage 96-well plate is an ultra-filtration plate which requires vacuum filtration rather than centrifugation. Due to this, the results are uneven and inconsistent, and there is no complete elimination of unincorporated dyes. A second unit is the Princeton Separations Centri-Sep 96-well plate. The plate contains a preservative. It also needs to equilibrate at room temperature for a couple of hours, and therefore prolongs the procedure. Lastly, the Agentcourt CleanSeq is based on magnetic beads, a completely different technology from what AFMES-DNA Ops uses. The CleanSeq is usually optimized on a robotic platform, and requires extensive optimization efforts. Cost is a factor to procure a new machine, training of staff and lost man-hours of re-validating.

This would become very costly to AFMES and not in the best interest of the Government. Although there are many other chemicals that may be used for the removal of unincorporated Dye terminators, they have not been optimized to work with AFMES-DNA Ops forensically validated and accepted methods. The Edge performa DTR plates have been designed, previously optimized, and forensically validated for use in sequencing purification; including for use on equipment-specifically used by AFMES-DNA Ops for use in the identification of human remains via mitochondrial sequencing. The Edge Brand Name performa DTR plates have been tested and are compatible for use with: Life Technologies Genetic analyzers Model 3500xl, Model 3730, and DNA thermocyclers Model 9700 and

Proflex; and the Hamilton Robotics® STAR Line automated liquid handling workstations all of which are validated for use by the AFMES-DNA Ops. The samples are spun through the plates and directly into the AB PRISM®

MicroAmp® Optical 96 Well Reaction Plate used for capillary electrophoresis thereby saving a transfer step and reducing potential contamination and/or sample switching. Additionally, no other product has met the forensic needs of being contamination free, reproducible from lot to lot, and robust in performing their functions through continued assessment since 2003.

9. Interested Sources

A notice of intent to sole source as required by FAR 5.201 will be published on Beta.sam for fifteen (15) days and any proposals received will be considered.

10. Other Facts

a. Procurement History: Previous Contract and purchase order number are listed below.

1. Awarded Sept 2009 for under Previous authority for less than Full &

Open Competition

2. Awarded 12 Sept 2011 for 0 under Previous authority for less than Full

& Open Competition

3. Awarded 8 Sept 2017 for under Previous authority for less than Full &

Open Competition

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.

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.

13. 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 the following:

Price analysis

Cost analysis

IGE

Audit:

Other:

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.

USAMRAA

14. Contracting Officer Certification

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

Approval

Based on the foregoing justification, I hereby approve the procurement of Performa Dye Terminator Removal (DTR)

Ultra 96-Well plate kits on a sole source basis pursuant to the authority of the Simplified Procedures for Certain

Commercial Items, 41 U.S.C. 1901 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.

Special Advocate for Competition