SPECIAL NOTICE
65 -- GeneMapper ID-X
- Notice Date
- 8/15/2024 12:07:53 PM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- ARMY MED RES ACQ ACTIVITY FORT DETRICK MD 21702 USA
- ZIP Code
- 21702
- Solicitation Number
- HT942524R0147
- Response Due
- 9/1/2024 8:00:00 AM
- Archive Date
- 09/16/2024
- Point of Contact
- Christopher Cook, Phone: 3016192640
- E-Mail Address
-
christopher.l.cook68.civ@health.mil
(christopher.l.cook68.civ@health.mil)
- Description
- This notice announces the intent by the U.S. Army Medical Acquisition Activity (USAMRAA), 820 Chandler St, Fort Detrick, Maryland, 21702, to award a sole source Firm-Fixed-Price (FFP) Contract to Life Technologies Corporation under the statutory authority 13.501(a). This contract is for 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, for the Armed Forces Medical Examiner Systems (AFMES). 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 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 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.� 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 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. The North American Industry Classification System (NAICS) for this requirement is 334516 and the size standard is 1,000.� This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to award a contract no sooner than 15 days after publishing this synopsis. This Special Request for Information 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. If no written responses are received by the expiration date listed in this notice, which reflects at least fifteen (15) days after the publication of this notice, the award will be issued as sole source. All questions and responses concerning this notice shall be emailed to Mr. Christopher L. Cook at christopher.l.cook68.civ@health.mil.�
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/e873744d37144b86bedcebf178998a83/view)
- Place of Performance
- Address: Dover AFB, DE 19902, USA
- Zip Code: 19902
- Country: USA
- Zip Code: 19902
- Record
- SN07171340-F 20240817/240815230114 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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