A02-SSJ-FINAL_Redacted.pdf

Control Number: JA-24-08-1639 CUI

CUI

(Source Selection information - See FAR 2.101 and 3.104-4)

MEMORANDUM FOR RECORD

LIMITING COMPETITION AT OR BELOW THE SIMPLIFIED ACQUISITION

THRESHOLD (SAT)

1. Contracting Activity: The contracting activity for this action is the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD 21702.

2. Description of Action: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Request Number:

Blanket Purchase Agreement (BPA) Number _______________ Order/BPA# _______ against FSS Contract #_____ _________ Order #___________ against Multiple Award IDIQ Contract

Name or #______________ Order #_______ against a single award IDC Contract

Modification # _______ to existing PO/TO/DO/Call Order

Pricing/Contract Type: Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) Other Funds:

Name of Proposed Contractor(s) and Address:

Life Technologies Corporation 3175 Staley Road, Grand Island, NY 14072 Phone: 1-800-955-6288 Unique Entity ID: JXAKAG32BVN4 Cage Code: 0JLD2

Brand Name Buy: Yes No

3. Description of Services or Supplies: The AFMES-DNAOps is requiring the purchase and delivery of three (3) Each of the version 1.7 GeneMapper ID-X software (full install upgrades), and Twenty (20) Each of the version 1.7 GeneMapper ID-X client upgrades to replace the existing version 1.6 GeneMapper ID-X full installs and the version 1.6 GeneMapper ID-X client installs. The GeneMapper ID-X version 1.6 no longer meets the Department of Defense’s (DoD’s) Local Area Network (LAN) specifications and is also not Windows 11 compatible. The upgrade from GMIDx 1.6 to GMIDx 1.7 is mandated as part the ongoing AFMES LAN Authorization and Assessment as directed by AFMES’s Authority to Operate (ATO). This software is in

(Source Selection information - See FAR 2.101 and 3.104-4) compliance with DoDI 8510.01 Risk Management Framework (RMF) and Vulnerability Management for DoD Information Technology (IT), which includes the DoD wide requirement to have software be Windows 11 compliant. Systems and/or applications within the AFMES LAN are required to be part of the vulnerability management process.

The most recent version of GMIDx, which is currently v1.7 has moved from an ORACLE database to a PostgreSQL database, which removes the need for AFMES to apply the oracle quarterly security patches. Additionally, GeneMapper IDx version 1.7 is Windows 11 compliant. The SQL database and Windows 11 compliance will allow AFMES to remain compliant with DoD vulnerability and risk management framework requirements.

The requested software will be used to support AFMES-DNAOps mission of assisting 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-DNAOPS requires instruments that provide optimal performance for Short Tandem Repeat (STR) and mtDNA sequencing analysis of human remains. To minimize the variation between AB3500XL Genetic Analyzers Life Technologies instruments are made using GLP/GMP process as well as following and being ISO 18385 compliant.

The Life Technologies 3500XL Genetic Analyzer is a multi-color fluorescence-based DNA analysis system with 24 capillaries operating in parallel. It offers high-quality data and efficient sample processing. The instrument is used in mtDNA sequencing and STR fragment analysis. It provides an Automated Polymer Delivery System that enables one button operation from polymer delivery, sample injection to separation, detection, and data generation. In addition, the data collection software is easy to use, configurable to existing laboratory information management system and is streamlined for use with the GeneMapper ID-X software.

The Life Technologies GeneMapper ID-X software have been validated in accordance with the Federal Bureau of Investigations – Quality Assurance Standards (FBI-QAS) and the ISO-17025 Accreditation standards by AFMES-DNAOps to work in conjunction with the Promega Fusion and Life Technology Globalfiler and MiniFiler autosomal Short Tandem Repeat (STR) kits, and the Life Technology Y-Chromosomal STR kit. During proof of concept and development of the automated and manual STR amplification and AB3500XL analysis methods validated within AFMES-DNAOps; the GeneMapper ID-X analysis software was proven by the government to be reproducible; robust; reliable and consistent between version numbers. AFMES-DNAOps initially validated GeneMapper ID-x version 1 in 2005 and has consistently utilized this software due to accreditation and validation requirements. Vendors that produce reproducible and reliable software are essential for processing forensic casework samples and meeting AFMES-DNAOps mission requirements. Development, optimization, and validation of the automated and manual STR and mtDNA amplification and AB3500XL methods coupled with the GeneMapper ID-X software used to identify missing individuals were performed according to the ISO-17025 and FBI-QAS standards. The GeneMapper ID-X software has been used forensically validated methods for the past 19 years and the AFMES- DoD-DNA Ops requires sustained ability to purchase the newest version of the

(Source Selection information - See FAR 2.101 and 3.104-4)

GeneMapper ID-X software for continued operations. Failure to purchase this instrument and software will lead to mission degradation as the current version does not meet DoD mandated Windows 11 compliance.

Delivery Date: 30 September 2024

4. Authority:

FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited: The suggested source for this requirement is Life Technologies, 3175 Staley Road, Grand Island, NY 14072. Life Technologies is the sole manufacturer of the GeneMapper ID-X software version 1.7 listed in this document.

AFMES-DNAOps is a forensic DNA testing laboratory that is accredited by the ANSI National Accreditation Board (ANAB) under the ISO-17025 and FBI-QAS standards for DNA Forensic Laboratories. Based on accreditation adherence (Volume III of the Quality Manual and the FBI's Quality Assurance Surveillance (QAS) document), all equipment and software must be developmentally validated by the manufacturer and internally validated by the laboratory to all reagents used for DNA testing as well as pass a stringent quality control before being released for casework. Forensic accreditation standards state that manufactures who supply DNA forensic instruments and reagents must be International Standard Organization (ISO) 18385 Forensic DNA grade accredited. Life Technologies is the only ISO 18385 Forensic DNA grade compliant for the reagents that generate the STR results analyzed in the GeneMapper ID-X software at AFMES.

AFMES-DNAOps is the only DoD human remains DNA testing laboratory, under title 10 USC, chapter 75, 1471 and 10 USC, Chapter 76, 1501-1513; NDAA 2010, Section 541 (d)(2) and DODI 5154.30 which is charged with providing human remains DNA testing in support of current day operations (AFMES), past accounting operations (Defense POW/MIA Accounting Agency; DPAA), other DoD Agencies missions, and, other Bureaus of the Federal Government, and civilian medical institutions. The GeneMapper ID-X software version 1.6 utilized by AFMES-DNAOps in support of mission requirements no longer meets ongoing AFMES LAN Authorization and Assessment as mandated by AFMES’ Authority to Operate (ATO) or the DoDI 8510.01 Risk Management Framework (RMF) and Vulnerability Management for DoD Information Technology (IT). and is no longer compliant with the DoD mandated Windows 11updates.

Therefore, Life Technologies is the only company that can fulfill this requirement. The GeneMapper ID-X version 1.0 through 1.6 software has been validated in accordance with the Federal Bureau of Investigations – Quality Assurance Standards (FBI-QAS) and the ISO-17025 Accreditation standards by AFMES-DNAOps to work in conjunction with the Promega Fusion and Life Technology Globalfiler and MiniFiler autosomal Short

(Source Selection information - See FAR 2.101 and 3.104-4)

Tandem Repeat (STR) kits, and the Life Technology Y-Chromosomal STR kit.

Development, optimization, and validation of automated and manual STR amplification methods in conjunction with GeneMapper ID-X data analysis software are is needed to support AFMES-DNAOps mission of assisting 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. Without this updated software, the AFMES Mission would not be able to identify human remains from past or present conflicts and bring closure to the families of the fallen.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the $ threshold, apply and will be followed, or do not apply due to an exception at 5.202

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

Action is NOT a brand name restriction and is under $250K, no posting required Action is a brand name restriction, under $25K, no posting required Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K but will not be posted due to exception:

7. Market Research: Prior to the decision to implement a product into the laboratory at

AFMES-DNAOps, extensive studies are performed to determine, which product possesses the desired properties. The AFMES-DNAOps is a forensic DNA testing laboratory that is accredited by the American Society of Laboratory Directors to the

International Organization Standards (ISO)-17025, American Society of Laboratory

Directors/Lab-International supplemental, and the Federal Bureau of Investigations

(FBI) Quality Assurances Standards (QAS). All accredited laboratories are required to follow the FBI-QAS reagent, instrument, software validation requirements, prior to utilizing any reagents, instrumentation, and/or software for testing casework samples. In accordance with these requirements, the GeneMapper ID-X was purchased to replace the discontinued GeneScan/Genotyper software in 2005. As of April 2024, Life

Technologies is the sole manufacturer and distributor of the GeneMapper ID-X software and there are no other suppliers that can provide this software to meet AFMES’s requirements.

8. Other Facts:

(1) Contract Numbers and dates of the last several contracts for the purchase of the

AB 3500XL:

(Source Selection information - See FAR 2.101 and 3.104-4)

a. A sole source Blanket Purchase Agreement contract HT9425-23A-0008 for the delivery of reagents and consumables that are required for use in Human remains DNA testing and require the use of GeneMapper IDx software; was awarded on 09 December 2022.

b. A sole source procurement contract W81XWH-22-P-0121 for the replacement of 1 existing 3500XL Genetic Analyzers due to end of lifecycle was awarded on 08 Aug 2022.

c. A sole source procurement contract W81XWH-21-P-0147 for the replacement of 2 existing 3500XL Genetic Analyzers due to end of lifecycle was awarded on 11 September 2020 for the purchase of 2, 3500XL Genetic Analyzers.

d. A sole source procurement contract W81XWH-21-P-0140 for 3 full GeneMapper IDx v 1.6 licenses and 50 GeneMapper IDx v 1.6 client licenses to meet DoD IMIT compliance requirements was awarded on 26 July 2021 for the purchase of 2, 3500XL Genetic Analyzers.

e. A sole source procurement contract W81XWH-17-P-0275 for the replacement of existing 3130XL Genetic Analyzers due to end of lifecycle was awarded on 11 September 2017 for the purchase of 2, 3500XL Genetic Analyzers.

f. A sole source procurement contract W81XWH-13-P-0531 for the replacement of existing 3130XL Genetic Analyzers due to end of lifecycle was awarded on 13 September 2013 for the purchase of 7, 3500XL Genetic Analyzer and 3 full installs of GeneMapper ID-X version 1.4

(2) Competitive status of these actions.

a. Sole Source Procurement

(3) Authority previously used for less than full and open competition.

a. The statutory authority permitting Other Than Full and Open Competition is 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(B), Only one responsible source and no other supplies or services will satisfy agency requirements.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph #7 of the justification for that procurement and an explanation of the results.

a. The previous justification was the same as this request. The justification was accepted, and the products were purchased from Life Technology.

(Source Selection information - See FAR 2.101 and 3.104-4)

(5) If any prior award was accomplished by full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

a. Not Applicable. All previous requirements were awarded as a sole source.

(6) An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive, urgent buys.

a. Not Applicable.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes.

a. Life Technology is the sole manufacturer and distributor of the requested

GeneMapper ID-X Software. There has been no significant changes to equipment that utilizes this software. This software is still urgently needed for the vital AFMES mission.