CONTROL SET, HUMAN S

The contract pertains to the procurement of a Control Set, Human Serum, specifically designed as I-STAT CK-MB Calibration Verification Controls Levels 1–3 for creatine kinase MB mass measurements, used as an aid in diagnosing and treating myocardial infarction. Each set contains two 1 mL vials of each of the three control levels, totaling six vials per set, and must have a non-extendable 12-month shelf life from the date of manufacture. No more than two months may have elapsed between the manufacturer’s date and the date of delivery to the government. Labeling must strictly adhere to MMS1A standards, including the manufacturer date, expiration or retest date, contract number, and lot number. Packaging must be commercial-grade, compliant with MIL-STD-2073-1E and DLA’s RP001, and marked according to MMS No. 1, which supersedes MIL-STD-129 for medical items. Barcoding must follow MIL-STD-129 requirements with UCC/SCC-14 barcodes. The item is identified by NSN 6550-01-627-2276, with a single set to be delivered to Kadena Air Base, Okinawa, Japan, within 20 days after award under FOB Destination terms. Delivery is scheduled to support medical monitoring needs at the designated location. The contract includes multiple regulatory and compliance requirements under FAR and DFARS, including mandatory adherence to DFARS 252.204-7012 for safeguarding covered defense information and reporting cyber incidents, necessitating full implementation of NIST SP 800-171 controls and submission of a system security plan and assessment score via SPRS. Contractors must also comply with whistleblower protections, restrictions on covered defense telecommunications equipment, and requirements for disclosing entity information, including UEI and CAGE codes. Invoicing must be submitted electronically through WAWF, and all packaging, preservation, and marking must conform to DLA’s medical-specific standards. The procurement is classified as a simplified acquisition under FAR 52.213-4, with contract type to be determined by the contracting officer. The solicitation, issued under SPE2DS-26-T-067R, closed for responses on May 18, 2026, and requires offerors to specify their source and part number. No