SPECIAL NOTICE
66 -- Notice of Intent to Sole Source Verogen Reagents and Consumables
- Notice Date
- 4/28/2023 9:18:28 AM
- 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
- HT942523JC0428
- Response Due
- 5/13/2023 9:00:00 AM
- Point of Contact
- James Cheng, Phone: 3016191012
- E-Mail Address
-
james.cheng1.civ@health.mil
(james.cheng1.civ@health.mil)
- Description
- This notice announces the intent by the U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the Armed Forces Medical Examiner System (AFMES) to procure Verogen reagents and consumables without competition as prescribed in FAR 13.106-1(b)(1). The required reagents and supplies are used to support the AFMES-DNAOPS mission of identifying fallen service members from past conflicts (World War II, Korea, Vietnam, and Cold War). These reagents and supplies have been designed, previously optimized, and validated specifically for forensic laboratories, including equipment- specific for the various procedures of DNA identification. The suggested source for this requirement is Verogen, a Qiagen Company. Verogen is the sole manufacturer and reseller for the customized reagents and consumables. The AFMES-DNAOPS is a forensic DNA testing laboratory that is accredited by the ANSI National Accreditation Board (ANAB) to the ISO-17025 and the Federal Bureau of Investigations (FBI) Quality Assurances Standards (QAS). All accredited laboratories are required to complete the FBI-QAS reagent, instrument, and software validation requirements, prior to utilizing any reagents, instrumentation, and/or software for testing casework samples. Once a DNA testing reagent, instrument or software has been identified for use with the laboratory�s casework samples the accreditation standards for the validation of new reagents, instruments and software require the Forensic Laboratory to perform: 1.�� �Precision and Accuracy 2.�� �Sensitivity and Stochastic Studies 3.�� �Reproducibility 4.�� �Mixture Studies 5.�� �Contamination assessment 6.�� �Non-probative casework samples 7.�� �Known samples Prior to identifying Verogen reagents and supplies for use at the AFMES- DNAOPS, vendors were assessed against other commercial equivalents. The assessment included performing limited sensitivity, precision, and non-probative casework experiments. The Verogen reagents generated results that were more sensitive, reproducible, and repeatable with samples typically processed at AFMES-DNAOPS in support of AFMES missions; and were then validated for use following accreditation standard guidelines. The Verogen reagents listed in this source requirement have been validated for use with: Illumina Next Seq 550 and the Verogen MiSeq FGX Next Generation Sequencing (NGS) instruments, the Agilent Fragment Analyzer Quantification instrument, DNA thermal cyclers Model 9700, Verti, and Proflex for next generation sequencing library preparation; Promega Maxwell 48 Robotic platform for DNA extraction; and the Hamilton Robotics STAR Line automated liquid handling workstation for DNA extraction and NGS library preparation. Although there are other commercially available kits or supplies, these kits and reagents were shown to be less sensitive, reproducible, and repeatable and the use of these kits or supplies would require extensive optimization and validations prior to implementation. The accreditation standards are very specific in that if a new kit, reagent, or supply is introduced into a currently validated forensic DNA testing method, the laboratory must perform a full validation. Failure to utilize the forensically validated Verogen 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 kits as well as retrofit or buy new instrumentation compatible with other commercially available kits. These reagents and consumables were specifically developed by Verogen for DNA forensic testing and validated according to the FBI-QAS and ANAB ISO-17025 accreditation standards by the AFMES-DNAOPS to work in conjunction with AFMES-DNAOPS�s current NGS analysis instrumentation and accredited standard operating procedures. Instrumentation associated with the Verogen reagents include the Illumina NextSeq 550 and the Verogen MiSeq FGX Next Generation Sequencing (NGS) instruments, the Agilent Fragment Analyzer Quantification instrument, DNA thermal cyclers Model 9700, Verti, and Proflex for next generation sequencing library preparation; Promega Maxwell 48 Robotic platform for DNA extraction; �and the Hamilton Robotics STAR Line automated liquid handling workstation for DNA extraction and NGS library preparation. Switching the reagents and consumables would require significant re-validations, the need to purchase new robotic platforms that are compatible with these alternative products, the need to pay for custom computer programming of AFMES-DNAOPS�s Laboratory Information System Analysis module, an in house developed Laboratory Information Management System (LIMS) system that currently is maintained by Future Technology Inc. Further, AFMES' mission requires consistency and standardization of testing to accomplish its overall mission and to maintain credibility due to the highly degraded DNA samples tested by the laboratory. AFMES demonstrated that the DNA samples provided by the DPAA are as damaged as 40K year old Neanderthal DNA and that these samples will not work with commercial off the shelf (COTS) next generation sequencing kits. Therefore, AFMES had to buy separate NGS reagents kits, NGS library indices and NGS sequencing chips to develop its validated NGS mtDNA capture, NGS family Reference, and NGS nuclear SNP methods. Vital to the DNA identification mission is the need for reproducible and accurate test results with no lot-to-lot variability as determined through extensive internal validation studies. These methods have been in use since 2016 and the reagents have been shown to be consistent from lot to lot and year to year, which has allowed AFMES to maintain a high level of standardization in the laboratory. Utilizing two different NGS sequencing instruments and reagents with different analysis thresholds and analysis parameters removes the consistency and standardization required for human remains testing and introduces an unacceptable level of error. This announcement fulfills the synopsis requirements under FAR 5.102 (a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. 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. If no written responses are received by the date listed below, which reflects at least fifteen (15) days after the publication of this notice, the solicitation will be issued as sole source requirement. All questions and responses concerning this notice shall be emailed to James Cheng at james.cheng1.civ@health.mil. Interested concerns must identify their capability in writing to the above email address listed above no later than 12:00 PM ET, 13 May 2023.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/e355cdb7d24c4233bac6a862c9b681d5/view)
- Place of Performance
- Address: Dover AFB, DE 19902, USA
- Zip Code: 19902
- Country: USA
- Zip Code: 19902
- Record
- SN06665845-F 20230430/230428230109 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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