FAR Part 13 JA Qiagen Master Service Agreement - Redacted.pdf

Control No.: Eisenhower 2025-5

Legal Counsel:

COM:

Date: See digital signature

Director, MICC-Ft. Eisenhower:

DSN:

Date: See digital signature

4. Authority Cited: Simplified Procedures for Certain Commercial Items, Title 41 U.S.C.

1901 (or Title 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

☒ Other: Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. Reason for Authority Cited:

a. The United States Criminal Investigation Laboratory (USACIL) located at the

Gillem Enclave in Georgia, provides forensic laboratory services to the Department of Defense investigative agencies and other Federal law enforcement agencies. The US Army Criminal Investigation Laboratory DNA Branch, Advanced XL DNA extraction instruments, and supplies produced and marketed by QIAGEN Inc. The purchasing of these supplies will ensure continuity of ISO 17025 ANSI-ASQ National Accreditation Board accredited processes at USACIL.

QIAGEN Inc holds the patents and is the only company that manufactures QIAGEN instrumentation, performs installation and provides maintenance and training services for this equipment. The manufacturer provided a proprietary letter.

b. Alternatives. There are no other alternatives. QIAGEN Field Service is the only organization certified by QIAGEN to Repair, Qualify, Calibrate, Upgrade, Maintain and Move QIAGEN instrumentation. Attempts to perform any Repairs, Calibration, Preventive Maintenances or Moves by organizations or individuals other than QIAGEN Field Service or those directed by QIAGEN Field Service, immediately and irrevocably void any QIAGEN Warranties or QIAGEN Support Agreements. This would compromise ongoing DNA research and potentially invalidate forensic examination laboratory results. Other manufacturers of DNA extraction instrumentation have been evaluated at USACIL and compared with the Qiagen EZ1 Advanced XL DNA extraction instruments. The Qiagen EZ1 Advanced XL DNA extraction instruments provided the best quantity and quality of DNA extracts in that comparison. If other DNA extraction equipment were purchased from a different vendor, that equipment would have to be subjected to a lengthy and costly validation process before use and demonstrate the ability to provide the quality of DNA extraction results, we obtain from the Qiagen equipment

c. Impact if justification not approved: Failure to obtain approval of this J&A will result in USACIL not being able to obtain the equipment required to maintain ISO laboratory processes for mission critical criminal and sexual assault investigations.

6. Efforts to Obtain Competition: USACIL scientists are continually researching sources of information and services to enable forensic examiners to conduct effective and reliable examinations. Market research consists of internet research, literature reviews and face to face discussions with vendors, and other professional resources attending forensic science and technology conferences and industry events. If USACIL identifies a similar requirement, every effort will be made to compete it to the maximum extent possible.

7. Actions to Increase Competition: To increase competition, MICC-Fort Eisenhower will continue to synopsize and conduct market research to ensure there are no other vendors that can provide the requirement. The Government will issue a Notice of Intent and address any responses accordingly, however QIAGEN Field Service is the only