Notice of Intent to Sole Source Illumina brand NextSeq

 THIS IS A NOTICE OF INTENT TO AWARD A SOLE-SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE PROPOSALS.The United Stated Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis, IAW FAR 6.302-1(a) (2) (ii), with Illumina, Inc. 5200 Illumina Way, San Diego, CA 92122-4616, as the only responsible source than can provide the required NextSeq 550 Sequencing System and consumables.  This acquisition is being conducted under FAR Part 12 Acquisition of Commercial Items.  Provisions and clauses in effect through Federal Acquisition Circular 2005-99; 15 June 2018 are incorporated. The Armed Forces Medical Examiner System (AFMES), Armed Forces DNA Identification Laboratory (AFDIL) intends to procure firm-fixed-price purchase order for NextSeq 550 Sequencing System and consumables used in the amplification and extraction procedures for human remains DNA Identification. Illumina Items being included in this acquisition:NextSeq 550 Sequencing

SystemNextSeq Silver Support PlanNextSeq 500/550 High Output Kit v2.5 (75 cycle)NextSeq 500/550 High Output Kit v2.5 (150 cycle)NextSeq 500/550 High Output Kit v2.5 (300 cycle)  The Armed Forces DNA Identification Laboratory (AFDIL) 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). The Armed Forces Medical Examiner System's-Armed Forces DNA Identification Laboratory (AFMES-AFDIL) has validated new PCR amplification and sequencing techniques, specifically next generation sequencing (NGS), utilizing the Illumina MiSeq® instruments. Initially, this mtDNA Capture assay was developed for chemically treated samples associated with the Korean War, but recent disinterments associated with World War II losses have been chemically treated prior to burial. This has led to a 200% increase in the number of specimens requiring NGS testing and AFMES-AFDIL has exceeded the through-put of the MiSeq®'s. To support the increased NGS workload in the AFMES-AFDIL's DNA identification and data basing activities, three NextSeq® 550 Sequencing Systems are needed for implementing and further developing novel methods for recovering DNA data from the most difficult specimens and to increase the number of samples analyzed per week.Comparable equipment with even the very slightest differences would compromise the compatibility and consistency of DNA identification and lead to significant costs in reagents and man power hours to validate the a new platform.  Standardization of equipment and reagents is critical to ensure variances are mitigated. The equipment will be used to support their mandated missionIllumina, Inc. is the sole manufacturer and reseller for the validated equipment, customized and consumables required for this acquisition.  Based on AFDIL's accreditation requirements 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, Ilumina's equipment, reagents and supplies have been compared against other commercial equivalents; were deemed optimal for use with samples processed at AFDIL in support of AFMES missions; and were then validated for use following accreditation standards. Further, AFMES' mission requires consistency and standardization of testing to accomplish its overall mission and to maintain credibility, therefore, accuracy is critical to AFMES' mission. 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. Failure to utilize the forensically validated Illumina reagents and supplies will lead to work stoppage or mission delays and cause the government a significant amount of time and money to validate other commercial instruments and kits as well as retrofit or buy new instrumentation compatible with other commercially available kits. The intended procurement will be classified under North American Industry Classification System (NAICS) 334516, Analytical Laboratory Instrument Manufacturing with a Small Business Size Standard of 1,000 employees.  This notice of intent is not a request for competitive proposals and no solicitation document will be posted for this requirement. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification of this synopsis will be considered by the Government.  A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government.  Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.   Based on the above information, the only technically acceptable instrumentation and  consumables are provided by Illumina, Inc. 5200 Illumina Way, San Diego, CA 92122-4616,Submit email capabilities statements (using PDF, MS Word, Excel attachments) to Kimberly Hannan at kimberly.s.hannan.civ@mail.mil.  Statements are due no later than 10:00 A.M. EST on 28 August 2018.  No phone calls accepted.               Contracting Office Address:U.S. Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Fort Detrick, MD 21702-5014 Place of Performance:Armed Forces Medical Examiner System, 115 Purple Heart Drive, Dover Air Force Base, DE 19902  Contact Information: Kimberly S Hannan, Purchasing Agent, Phone 3016193490, Email kimberly.s.hannan.civ@mail.mil Office Address :Attn: MCMR-AAA820 Chandler Street Frederick, MD 21702-5014 MD 21702-5014 Location: U.S. Army Medical Research Acquisition Activity Set Aside: N/A