Notice of Intent.doc

This Notice of Intent to sole source by the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD acting on behalf of the Defense Health Agency (DHA), Armed Forces Medical Examiner System (AFMES), located at Dover Air Force Base in Delaware requests a Firm Fixed Price (FFP) contract with Life Technologies Corporation for the purchase, delivery, installation and maintenance of two independent 24 Capillary Applied Biosystems 3500XL Genetic Analyzer (AB3500XL) systems without competition as prescribed in FAR Subpart 13.106-1(b)(1).

The AFMES-DNAOps is requiring the procurement of two (2) new independent 24 Capillary AB3500XL Genetic Analyzers systems. The Genetic Analyzer procurement will also include associated software and maintenance to replace the two existing AB3500XL Genetic Analyzer systems that are over four (4) years past their defined End of Life cycle replacement. The required instrumentation, computers and software are 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.

Minimum Essential Characteristics Key Features:

· 24-capillary system

· Advanced thermal system to improve temperature control for demanding DNA fragment analysis applications

· Single-line 505 nm, solid state long-life laser that utilizes standard power supply , requires no heat removal and provides signal uniformity from instrument-to-instrument, run-to-run, and capillary-to-capillary

· Integrated data collection and primary analysis software to provide real-time assessment of data quality for sequencing and/or short tandem repeat analysis.

· Data collection software that can analyze 6 dye chemistries; has a dashboard monitoring system that monitors number of runs remaining with current polymer, anode and cathode buffers, and number of runs on the capillary; designed with wizards for ease of use and maintenance; and has software that can perform chemistry checks to verify quality of Data.

· System software must include features to support security, audit trail and electronic signature features required by 21 CFR Part 11 or ISO 17025 requirements.

· Data output files must be in the industry standard ABIF Format, which must be viewable on Windows® computing systems.

· System must be compatible with the previously validated AB3500XL data collection software version 4.0 or higher, GeneMapper ID-X version 1.4 or higher and Sequence Analysis software version 6 or higher.

· System must be able to provide consistency of DNA sequencing base calls and read length, and allele designations in relation to prior data obtained from the validated 3500 Data Collection software v 4.0 or higher in order to mitigate variances between old and new data sets.

· System must be able to sequence lower levels of DNA, in order to mitigate the loss of valuable data, essential to identification efforts.

· System must have ability to provide information that can be upheld in the courts, and have the general acceptance of the forensic community.

· System must meet all ANAB Accreditation Standards Board (ANAB) ISO-17025 standards and the Federal Bureau of Investigation’s (FBI) Quality Assurance Standards to ensure adherence to current accreditation (section IV of the Master Operating Plan and the FBI’s QAS document).

· System must by developmentally validated by the company and internally validated by the laboratory as well as pass a quality control (QC) performance check prior to being released for casework, ensuring reproducible and accurate DNA test results with zero variances.

· System must have the ability to use Radio Frequency Identification (RFID) technology to track key consumables data and record administrative information.

· System must have advanced multiplexing capabilities for DNA fragment analysis with up to six unique dyes, with predefined run modules and compatibility specifically for the following multiplex amplification systems: PowerPlex® Fusion, AmpFlSTR® Identifiler®, AmpFlSTR®, AmpFlSTR® Yfiler® and YFiler Plus, AmpFlSTR® MiniFiler™, and AmpFlSTR® GlobalFiler™ .

· Advanced sequencing capabilities and predefined company validated run modules for stretches sequencing mtDNA with BigDye® v1.1 Terminator Cycle Sequencing chemistry.

· Application flexibility-one array and one polymer are used for most applications

· The system must be designed with pre-packaged single-use consumables to consist of at a minimum Performance Optimized Polymers (POP4, POP6, and POP7) and 1X Cathode and Anode buffers in prefilled containers.

· All genetic analyzers must be validated to complete DNA casework from nuclear, mtDNA, Research, and BioAutomation process.

System Components and Operating Specifications:

· Capillary electrophoresis instrument

· 24-capillary array and polymer

· Must include a computer workstation with flat screen monitor compatible with Windows 10, 64 bit IOT Enterprise operating system.

· DNA Sequencing and/or Fragment Analysis, reagents and consumables for system qualification

· Integrated software for instrument control, data collection, quality control, and auto-analysis of sample files for base calling and fragment sizing.

· Laser – Single-line 505 nm, solid-state long-life laser—utilizes a standard power supply, requires no heat removal

· Electrophoresis voltage – up to 20 kV

· Oven temperature – active temperature control from 18°C to 70°C.

· Operating Environment – operating room temperature between 15°C to 30°C and not fluctuate by more than 2°C during instrument run and humidity between 20% to 80%

Minimum Computer Requirements:

A45279 - Optiplex XE3 500GB Tower Spec with Win10 IOT 2019-64Bit, ROHS

Main power Voltage

· 100 – 240V ± 10%

· 50 – 60 Hz ± 10%

Dimensions:

· 61 cm (closed door) width

· 122 cm (open door) width

· 61 cm depth

· 72 cm height

The North American Industry Classification System (NAICS) for this requirement is 339112 and PSC 6515.

This Special Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government.

All questions and responses concerning this notice shall be emailed to Brian Miller at brian.d.miller1.civ@mail.mil.

Interested concerns must identify their capability in writing to the above email address no later than 1:00 PM ET Local, 1 July 2021.