Attachement 2 25-MRCO-PACIFIC-281 Brand Name JA.pdf

Control Number:25-MRCO-PACIFIC-281

JUNE 2025

FAR Part 13 Justification and Approval Simplified Procedures for Certain Commercial Items

1. Requiring Activity: Madigan Army Medical Center (MAMC), Department of Pathology, Core Laboratory Division, Joint Base Lewis McChord, Tacoma, WA.

2. Contracting Activity: Joint Base Lewis-McChord Health Contracting Branch (JBLM-

HCB), R6100 North 18th Street, Joint Base Lewis McCord, WA.

3. Description of Action: The United States Government requests to award a new indefinite delivery indefinite quantity (IDIQ) firm-fixed price contract for a 5-year ordering period (Estimated 1 October 2025 through 30 September 2030), with an estimated contract ceiling amount This requirement is for the supply of brand name quality control reagents and a Unity Real Time Software License for use with government owned laboratory instrumentation. The contract’s delivery orders will be fully funded using appropriate fiscal year (FY) Defense Health Program funds.

Brand Name Contractor: Bio-Rad Laboratories Inc.

Address: 4000 Alfred Nobel DR, Hercules CA, 94547

4. Description of Supplies/Services: The government requires specific Bio-Rad Laboratories Inc., manufactured quality control reagents to perform quality control analysis on government owned laboratory instrumentation. All quality control reagents must be Food and Drug Administration (FDA) approved and have an FDA 510K approval application. Additionally, the government requires that the quality control reagents be supplied with sequestered lot numbers to ensure no more than one lot change occurs per year. The delivery of quality control reagents necessitates strict temperature-controlled shipping and delivery requirements with specific marking instructions. A table of all quality control materials with estimated contract quantities is shown on the next page. The government also requires supply of the Bio-Rad Laboratories Inc., owned Unity Real Time Software License. The Unity Real Time Software must meet regulations from Clinical Laboratory Improvement Amendments (CLIA) ’88 and College of American Pathologist (CAP) requirements.

Anticipated delivery orders will be placed for deliveries of supplies occurring over a period of 12 months. Subsequent delivery orders will be issued as additional supplies of quality control reagents are required.

Control Number:25-MRCO-PACIFIC-281

JUNE 2025

5. Authority Cited: Title 41 United States Code (U.S.C.) §1901(e)(2) as implemented in Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), including brand name, under the authority of the simplified procedures for certain commercial items.

6. Reason for Authority Cited:

a. Background: The Centers for Disease Control and Prevention and the FDA require accredited laboratories to detect, reduce, and correct deficiencies in laboratory processes as part of their quality control to ensure patients receive accurate results. Using a vendor that is not a direct manufacturer of the analyzers used by MAMC provides the level of quality control that the MAMC’s Department of Pathology accrediting body requires. Some analyzer manufacturers provide both calibrators and quality control reagents for use on their analyzers. These quality control reagents are often manufactured from the same materials as the calibrators. Consequently, the quality control reagents may mimic the calibrator, making it less sensitive to changes in test performance. This may lead to patient test results with analytical error that could be medically important. Therefore, the government requires quality control reagents from a source other than the original equipment manufacturer of the analyzers used by MAMC. Furthermore, quality control data management software is required to maintain strict accreditation compliance standards as outlined by the College of American Pathologists. Quality control data management software provides statistical review, documentation, and analysis across all controls used in the laboratory. In addition, the software for this requirement must be listed on the Defense Health Agency’s (DHA) Approved Product List.

1) This is not a justification for a follow-on contract for the continued development or production of a major system, highly specialized equipment, or major components thereof.

2) Bio-Rad Laboratories Inc. is the only company able to manufacture the required quality control reagents that are FDA approved and are compatible with existing quality control needs of the Department of Pathology’s analyzers located at MAMC. The Unity Real Time software is a quality control data management software that computes and transmits data from quality control samples. Unity Real Time software is designed to analyze all quality control data to assist the laboratory staff in completing their quality control tasks per laboratory policy and regulations. The Unity Real Time software license is critical to the MAMC’s Department of Pathology mission and necessary to perform quality control analysis on all analyzers. The Unity Real Time software is the only compatible software that is also on the DHA Approved Product List. Bio-Rad Laboratories Inc, wholly owns and maintains the Unity Real Time software. Bio-Rad Laboratories Inc. or through there authorized vendors issues licenses for use of the software to government and commercial medical facilities.