JFOC-QIAGEN-SAM POST.pdf

FEDERAL BUREAU OF INVESTIGATION

FINANCE and FACILITIES DIVISION | PROCUREMENT

SECTION

JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN FULL

AND OPEN COMPETITION GUIDE AND TEMPLATE

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION IN ACCORDANCE WITH 41 U.S.C. 3304 (A) (1)

Requisition Number: SHOP-OY-24-001889

Date: 03/13/2024

Estimated Contract Dollar Value: $XXX

1. Identification of the agency and contracting activity.

The U.S. Department of Justice, Federal Bureau of Investigation (FBI), National Acquisition Programs Unit (NAPU), have prepared this justification for other than full and open competition for a multiple-year contract for QIAGEN reagents and consumables on behalf of the Laboratory Division’s (LD) DNA Casework Unit (DCU).

2. The nature and/or description of the action being approved, i.e., sole source, limited competition, establishment of a new source, etc.

This Justification of Other Than Full and Open Competition is for the proposed acquisition of a firm fixed price, multiple-year contract consisting of a base year and four (4) Option Years (OY) for QIAGEN reagents and consumables in support of the DCU and the Terrorist Explosive Device Analytical Center (TEDAC).

3. A description of the supplies or services required to meet the agency’s needs.

The proposed action is for the reagents and consumables that are necessary for the DNA processing of casework evidence, missing person cases, and DNA Database samples. In addition to requiring these reagents and consumables for casework processing, these items are also needed by the TEDAC for research projects in support of the LD. Reagents are specially designed chemical mixes that are used in highly sensitive robotic instruments to cause a desired reaction for a specific result.

4. The statutory authority permitting other than full and open competition.

The statutory authority permitting other than full and open competition is 41 U.S.C. 3304 (a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

5. Demonstrate the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

This will be a sole source procurement as QIAGEN Science LLC is the only supplier of the semi-automated DNA extraction kits validated for use by the FBI’s DNA Casework Unit (DCU).

The DCU employs two major QIAGEN chemistries for semi-automated DNA extraction from questioned specimens The EZ1 DNA Investigator Kit and QIAsymphony DNA Investigator Kit. In testing and evaluation, these kits, when used in combination with Qiagen robots demonstrated exceptional recovery of DNA from evidence samples - including low level samples, mixtures, and samples that are unpredictable in nature. The kits also greatly improved casework efficiency and case turnaround times. As a result, the kits were validated on Qiagen robots by the FBI laboratory for use in the FBI’s DNA casework. Validation work was extensive and performed in accordance with the Scientific Working Group on DNA Methods Validation Guidelines and the FBI’s Quality Assurance Standards for Forensic DNA Testing Laboratories (refer to section 9). Qiagen is the only supplier of these two FBI validated kits.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

The FBI will publicize this requirement on the Federal Business Opportunities website on SAM.gov. The announcement will give an opportunity for other vendors to demonstrate their ability to meet the FBI's specific needs through a submission of technical capabilities and cost information.

7. The anticipated dollar value of the proposed acquisition, including options if applicable, and a determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The estimated cost for the proposed contract for reagents and consumables is approximately $XXX, as shown in the chart below. The contract will include provisions for Firm Fixed Price (FFP) tasks and delivery orders.

DCU DSU

Grand Total

2024 XXX XXX XXX

https://www.acquisition.gov/far/html/Subpart%205_2.html#wp1107980 https://www.acquisition.gov/far/html/Subpart%205_2.html#wp1107990

2025 XXX XXX XXX

2026 XXX XXX XXX

2027 XXX XXX XXX

2028 XXX XXX XXX

The overall contract amount would be $ XXX.

8. A description of the market research conducted and the results.

The FBI conducted market research for this requirement through internet searches and reviewing technology releases from journals and papers. QIAGEN is the sole manufacturer and distributor of their instruments and consumables. The FBI’s LD has previously validated earlier versions of QIAGEN’s DNA extraction instruments, and these instruments are the only instruments in use operationally by the DNA Casework Unit, (DCU).

The Contracting Officer contacted Qiagen to verify that there are no other authorized resellers of the requested reagent and consumable kits. Per the manufacturer, Qiagen holds exclusive rights and is the only provider of the MiSeq FGx Sequencing System, ForenSeq reagents, and associated forensic validation service.

9. Any other facts supporting the use of other than full and open competition.

It is noted the DCU must comply with the Quality Assurance (QA) Standards for Forensic DNA Testing Laboratories, as established by the FBI Director in September 2011. These QA Standards specify the following with regard to the required internal validation of the DNA extraction kits:

• Only validated methodologies (including DNA extraction kits) may be used for DNA analyses (Standard 8.1.).

• Any change of test kit requires that our validation studies be repeated (Standard 8.3.3).

• The validation studies must define the quality assurance parameters and interpretation guidelines that are to be used (Standard 8.3.2.). The FBI would need to re-evaluate and re-write its procedures based on the results of any new validation studies.

• The validation studies must be reviewed and approved by the Biometrics Analysis Section (BAS) Technical Leader prior to implementation of a new extraction system (Standard 8.3.).

• Before the introduction of an extraction kit into the laboratory, the analyst or examination team must successfully complete a competency test (Standard 8.4.).

Aside from the fact that no other kits work on the FBI’s Qiagen robots, conducting an internal validation for another DNA extraction kit to be utilized by the LD is very labor intensive.

Validation of new extraction chemistry would require extensive testing to ensure that the results produced from new kits were as good or better than the results of the current Qiagen kits. Following these studies, new kits would have to be integrated into a system and LIMS that is already designed to the Qiagen kit specifications. It has been the experience of the DSU that the internal validation of a new extraction chemistry would take approximately 1 year based on the DSU’s current staffing level and, given the substantial personnel, time and resources required, would cost the FBI roughly hundreds of thousands of dollars. Furthermore, if issues or hurdles were encountered at any stage of testing, validation, or integration of a new kit and DCU implementation couldn't be accomplished in a timely manner - or accomplished at all -casework operations would be put at risk, resulting in increased turnaround times and backlogs.

10. A listing of any sources that expressed a written interest in the acquisition.

A search was conducted on SAM.gov and a Notice of Intent (NOI) to purchase Qiagen reagents and consumables was published with negative results. No other vendors expressed an interest in meeting the Bureau’s needs. Please see notice ID DJF-14-0700- P-0010103.

11. A statement of any actions the agency may take to remove or overcome any barriers to competition, if subsequent acquisitions are anticipated.

The FBI will continue to conduct market research available through industry shows and technology releases in the form of papers and journals. This will be used to identify potential sources for subsequent acquisitions. If potential sources are identified, they will be required to submit to compatibility and validation testing, which the FBI continues to conduct subject to resource limitations. The initial compatibility study is to ensure that the FBI Laboratories robotic systems, which are a substantial capital investment for the Federal Government, are compatible with the offeror's solution. The second study is to validate the science, equipment, and materials behind the offeror’s technology. The FBI Laboratory holds itself to the highest standards within the forensic community and ensures that any technology used is proven, tested technology.

COs are not permitted to proceed with solicitation until this document is fully executed by each signatory in accordance with the thresholds identified below:

Reviews and Approvals ($750K to $5M)

Requestor:

I certify that the facts and representations under my cognizance, which are included in this justification, and which form a basis for this justification, are complete and accurate.

Signature Date

Contracting Officer:

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

Signature Date

Reviewed and Approved by:

Team Lead Contracting Unit:

Signature Date

Unit Chief Contracting Unit:

Signature Date

Reviewed and Approved by:

Competition Advocate:

Signature Date