Redacted Justification and Approval (JA)_Hamilton.pdf

CUI

Control Number:JA26-0790

Controlled by: Defense Health Agency (DHA) Controlled by: CB10 CUI Category(ies): Source Selection Limited Dissemination Control: FEDONLY POC: Kasey Carroll

Source Selection Information - See FAR 2.101 and 3.104-4

1 OCT 2024

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

Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) Parts 6 and 12 Implemented by Class Deviation 2026-O0017, Revision 1

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), DHA Contracting Activity (DHACA), Research and Development-Contracts Group 2 in support of The Armed Forces Medical Examiner System DNA Operations (AFMES-DNA OPS).

2. Nature and/or Description of Action being Approved: This will be a Firm Fixed Price contract.

3. Description of Supplies/Services and Estimated Value: AFMES- DNA OPS is requiring the purchase, delivery, installation, and extended warranty of one (1) Hamilton Microlab STAR Vantage 2.0 robotic workstation to replace an existing Hamilton STARLET robotic workstation that is End-of-Life (EOL).

The required Hamilton Microlab STAR robotic workstations, computers and software are used to support AFMES- DNA OPS mission of assisting Armed Forces Medical Examiner System (AFMES) and the Defense POW/MIA Accounting Agency (DPAA), with human remains Deoxyribonucleic Acid (DNA) testing for the identification of United States (US) 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 OPS requires the highly specialized Hamilton Microlab STAR liquid handling robots, computers and software for high throughput extraction, short tandem repeat amplification, and next generation sequencing of military DNA references and Family Reference specimens used to identify unknown human remains. AFMES-DNA OPS requires that the Hamilton Microlab STAR Vantage 2.0 provide optimal performance and that the variation between robots in the Hamilton Microlab STAR family of instruments are made using Good Laboratory Practices (GLP) / Good Manufacturing Practices (GMP) and that programs between the STAR Plus and STAR Vantage 2.0 are compatible..

DELIVERY DATE Estimated Value Type of Funding

30 SEPT 2026 $348,606.47

4. Statutory Authority Permitting Other Than Full and Open Competition: RFO 6.103-1(b), Only One Responsible Source

5. Rationale Justifying Use of Authority Cited: Hamilton is the sole manufacturer and reseller of the Hamilton Microlab STAR Vantage 2.0 robotic workstation listed in this document. The Hamilton Microlab STAR Vantage 2.0 is the newest model in the Hamilton Microlab STAR suite of robots and is replacing the older Hamilton STARLET. All previously developed and validated extraction, short tandem repeat amplification and next generation sequencing methods can be exported from the Hamilton

Control Number: JA26-0790

OCT 2024

STARLET or Hamilton Microlab STAR Plus and imported directly to the Hamilton Microlab STAR Vantage 2.0, which prevents the need for re-programing and re-validation of these methods. AFMES- DNA OPS is a forensic DNA testing laboratory that is accredited by the ANSI National Accreditation Board (ANAB) to AR3125, ISO-17025 and Federal Bureau of Investigations (FBI) Quality Assurances Standards (QAS). for DNA Forensic Laboratories. Based on accreditation adherence (Volume III of the Quality Manual and the FBI's 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. Furthermore, forensic accreditation standards say that manufactures who supply DNA forensic instruments and reagents must have established GLP/GMP processes. Hamilton also follows GMP process.

AFMES-DNA OPS is the only Department of Defense (DoD) human remains DNA testing laboratory, which under title 10 USC, chapter 75, 1471 and 10 USC, Chapter 76, 1501-1513; NDAA 2010, Section 541 (d)(2) and DODI 5154.30 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 Hamilton STARLET workstation was purchased in 2009 to replace the existing Corbett CAS-1200 and was validated for the extraction and amplification of population samples to expand the databases used by AFMES-DNA OPS for statistical analyses. The Hamilton STARLET workstations were purchased as a sole source procurement due to outperforming the existing Corbett workstation. This instrument is now 7 years past its end of live expectancy and is having significant maintenance issues.

Additionally, Hamilton Microlab STAR suite of robots (STAR Plus) workstations was chosen in 2011 to replace the existing TECAN robots as they outperformed the TECAN Evolution instruments. The Hamilton STAR Plus systems were validated for mitochondrial DNA (mtDNA) control region sequencing of material family references using Sanger-type sequencing. These workstations were later repurposed for library preparation as part of the validated next generation sequencing method for whole mtDNA analysis. The Hamilton STAR Plus workstations were recently replaced with Hamilton Microlab STAR Vantage 2.0 robotic workstations due to the EOL of the systems. Furthermore, Hamilton Microlab STAR suite of robots (STAR) was chosen in 2018 to replace the existing Beckman Coulter Biorobots as the Hamilton Microlab STAR workstation exceeded the capabilities of the Beckman Coulter Biomek FX Biorobots. To assist with the development of the robotic methods for the Hamilton Microlab STAR robots AFMES-DNAOps paid for custom blood card and oral buccal swab extraction and autosomal and Y-Chromosomal Short Tandem Repeat amplification methods. The current AFMES-DNA OPS Hamilton Microlab STAR workstations blood card and oral buccal swab extraction, and the Hamilton Microlab STAR Vantage 2.0 workstations perform library preparation for next generation sequencing methods.

The methods took over 36 months in total to develop, test, optimize and forensically validate. AFMES- DNA OPS validated the robotic platforms and the analysis methods discussed above in accordance with the ANSI National Accreditation Board (ANAB) to AR3125, ISO-17025 and Federal Bureau of Investigations (FBI) Quality Assurances Standards (QAS) standards for DNA Forensic Laboratories accreditation guidelines and implemented them into casework 2019.

The custom Hamilton Microlab STAR suite of robots (i.e., STAR, STAR Plus, STARLET, Vantage 2.0) have been forensically validated with robotic deck designs that have met and continue to meet the needs of AFMES-DNA Ops. However, the Hamilton Microlab STARLET is past its end of life, having significant maintenance issues, and is no longer complainant with DoD Windows 10 LTSC or Windows 11 (WIN 10 LTSC or WIN 11) operating system requirements and needs to be replaced. Hamilton has identified that the Hamilton Microlab STAR Vantage 2.0 is replacing the STARLET with another workstation from the Hamilton Microlab STAR suite of robots with enhanced capabilities. Additionally, the Hamilton Microlab STAR Vantage 2.0 has already been forensically validated for library preparation for next generation sequencing, which allows for the previously validated methods to be leveraged. The Hamilton Microlab STAR Vantage 2.0 uses either WIN 10 LTSC or WIN 11 operating system to run the Hamilton Microlab STAR Venus 6 software. The purchase of the Hamilton Microlab STAR Vantage 2.0 meets DoD Windows 10LTSC or Windows 11 mandates, provides 30% faster liquid handling, a completely enclosed work deck to reduce contamination events. All previously developed and forensically validated methods (including deck and consumable definitions) from any of the Hamilton Microlab STAR suite of robots can be imported, preventing the need to develop, optimize and forensically validate all new protocols and integrate those into the LIMS system. This is the reason AFMES-DNA OPS is seeking a sole source purchase of the Hamilton Vantage 2.0 Workstation to replace the currently obsolete Hamilton Microlab STARLET workstation.

6. Efforts to Obtain Competition: A Presolicitation Notice was posted to SAM.gov for 15 days, no responses were received.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: The Government will continue to monitor the marketplace.

8. Market Research: Market research was conducted in February- March 2025. The major players currently in large scale forensic robotic processing are Hamilton, TECAN, and Beckman Coulter.

AFMES-DNA OPS previously owned and utilized Beckman Coulter Biomek FX or Beckman Coulter Biomek 2000 Biorobots for nuclear extraction and short tandem repeat amplification and TECAN EVOs robotic workstations for mitochondrial DNA mtDNA amplification and Sanger Sequencing. When the Biomek FX and TECAN EVO robots reached end of life and were no longer meeting mission obligations, AFMES-DNA Operations looked to replace these robots. Through side-by-side comparisons, it was determined that the Hamilton Microlab STAR suite of robot’s workstation exceeded the capabilities of the Beckman Coulter Biomek FX Biorobots and the TECAN EVO biorobots. The Hamilton Microlab STAR Vantage 2.0 workstation allows AFMES-DNA OPS the ability to efficiently perform library preparation for downstream next generation sequencing methods on a single robust platform as it allows for the integrations of heating and cooling elements, plate sealers and thermal cyclers on or attached to the workstation.

Research at forensic meetings and from assessing the vendors web pages identified the following:

1. Hamilton Workstations

a. STAR plus workstation: 71 accessible deck positions that can be utilized for method development, utilizes the Venus software for running the instrument, operating system is Windows 10, which is not DoD compliant.

b. Hamilton Microlab STAR Vantage 2.0: replacing the STAR plus. Has 72 deck positions that can be utilized for method development; utilizes the Venus software for running the instrument, operating system is Windows 10 LTSC or Windows 11, which is DoD compliant; can import currently validated methods from the STAR plus Venus software to the STAR Vantage 2.0 Venus software; and is 79in L x 37in W x 38in H.

2. Beckman Coulter Biomek workstations

a. Biomek FX- is no longer being sold and has been replaced by the i-series workstations.

b. Biomek i7 workstation: 45 deck positions that can be utilized for method development, which is much smaller than the current footprint of the Hamilton Microlab STAR Plus or Vantage 2.0 and Windows 10 operating system, which is not DoD compliant. The Biomek i7 will not meet AFMES-DNAOps needs for the following reasons:

i. It is smaller than the STAR Vantage 2.0 and will not allow for development of fully integrated decks based on the currently validated Hamilton Microlab STAR Plus methods and deck specifications and definitions.

ii. Does not use Venus software so current methods could not be directly imported.

iii. Require extensive time and effort to program new methods and deck definitions, optimize the protocols and validate all new methods and deck configurations.

iv. Operating System is not DoD Compliant

3. TECAN Evolution workstation

a. TECAN Freedom EVO 200 base unit has 69 deck positions that can be utilized for method development; it is 80.7inL x 30.7inW x 34.5in high; and WIN 10LTSC which is DoD Compliant; uses EvoWare software. The TECAN Evolution 200 workstation will not meet AFMES-DNAOps needs for the following reasons:

i. It is smaller than the STAR Vantage 2.0 and will not allow for development of fully integrated decks based on the currently validated Hamilton Microlab STAR Plus methods and deck specifications and definitions.

ii. Does not use Venus software so current methods could not be directly imported.

iii. Require extensive time and effort to program new methods and deck definitions, optimize the protocols and validate all new methods and deck configurations.

iv. Operating System is not DoD Compliant

As mentioned above, purchasing the other instruments will not meet the needs of AFMES-DNA OPS as they are either smaller than the existing Hamilton Microlab STAR suite of robots or their operating software is not compatible with the Venus operating software, which prevents the use of existing methods. Failure to purchase the Hamilton Microlab STAR Vantage 2.0, which is replacing the Hamilton Microlab STAR suite of robots will lead to work stoppage or mission delays and cause the government a significant amount of time and money to pay for custom extraction, amplification, Sanger-type sequencing and next generation sequencing method development. As stated above, it took 36 months to have the custom blood card and oral buccal swab extraction, autosomal and Y-Chromosomal Short Tandem Repeat amplification, Sanger-type sequencing, and next generation sequencing methods developed, implemented and validated. For the purposes of the AFMES-DNA OPS mission, the physical properties (bench-top), technical advantage, and authorized operating system, the Hamilton Microlab STAR Vantage 2.0 system is the only system that is practical for replacing the existing Hamilton Microlab STARLET for use at the laboratory. The purchase of the Hamilton Microlab STAR Vantage 2.0 removes the need to develop and validate new methods as it allows for the direct import and updating of existing methods, thus shortening the time for implementation and all the operating software is DoD compliant.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No, HT942524P0168

(2) If 9.a.(1) is No, was the action just prior to this one competed? No, previous contract was sole source.

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed?

b. Additional Information: The AFMES-DNA OPS is a forensic DNA testing laboratory that is accredited by the ANSI National Accreditation Board (ANAB) to AR3125, ISO-17025 and 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. Since the current methods on the Hamilton Microlab STAR suite of robots can be imported and easily updated in the Hamilton Microlab STAR Vantage 2.0 Venus software, it significantly reduces the accreditation requirements prior to implementation.

10. Interested Sources: To date, no other sources have written to express an interest.

11. Technical Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Michael A. Fasano Chief, DNA Laboratory Services DNA Operations- AFDIL

12. Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Shairose Lalani DNA Program Manager

13. Contracting Officer Determination of Fair and Reasonable Pricing and Certification of Accuracy and Completion.

Fair and Reasonable Cost Determination:

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for Determination: This determination will be made using price analysis, and comparison with the IGE. Certified cost and price data is not required as per FAR 15.403-1(b)((3).

Contracting Officer Certification:

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

Courtney Piar Contracting Officer

DHACA