Notice of Intent to Sole Source - Document Control and Standards Maintenance HT9406

The Defense Health Agency Contracting Activity (DHACA) Healthcare Contracting Division- Southeast (HCD-SE) intends to negotiate on a sole source basis IAW FAR 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold, only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name, or industrial mobilization). The proposed source is MediaLab Solutions, LLC of 1745 N Brown Rd, Lawrenceville, GA 30043. The Naval Health Clinic Cherry Point (NHCCP), NC Laboratory Department has a requirement for Document Control and Standards Maintenance services. This requirement is for an annual subscription to utilize a web-based Laboratory Document Control and Standards Maintenance service accessible by username and password within one integrated system. Services include modules that contain all current laboratory standard operating procedures and forms, available real-time to lab staff; training and competency assessments to ensure current skills are maintained; accreditation standards for regulatory compliance; nonconforming events reporting for trend analysis and corrective action; and continuing education resources for required certification maintenance. The system shall meet the expected performance characteristics for Document Control, Competency Assessment, and Nonconforming Events Reporting as defined by the 1988 Clinical Laboratory Improvement Act (CLIA), College of American Pathologists (CAP), Joint Commission and Food and Drug Administration (FDA) standards for the Laboratory. The Contractor shall provide an all-encompassing service from a single vendor to includea) Document Control management system b) Competency Assessment management system c) Inspection and Accreditation management system d) Nonconforming Events Reporting tool e) Medical Laboratory Continuing Education There are no set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 611710. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Koffi Alognon at koffi.e.alognon.civ@health.mil . Closing date for challenges is no later than 5:00 PM ET on 26 January 2026. No phone calls will be accepted.

The Defense Health Agency Contracting Activity (DHACA) Healthcare Contracting Division- Southeast (HCD-SE) intends to negotiate on a sole source basis IAW FAR 12.102, For acquisitions valued at or below the simplified acquisition threshold (SAT), document the decision that only one source is available and the basis for the decision. The proposed source is Hologic Sales and Services, LLC of 250 Campus Drive, Marlborough MA 01752-3020. The Naval Medical Center Camp Lejeune (NMCCL), NC Laboratory Department has a requirement for TLiIQ System to include one tabletop analyzer and all necessary reagents, consumables, and other necessary supplies. This requirement is to provide continuation of fetal fibronectin testing within the Laboratory at NMCCL. Fetal fibronectin testing is deemed necessary by physicians to successfully care for pregnant patients as this test is used to determine pre-term labor. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 325413. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, vendors interested in responding to this notice will need to submit sufficient technical data to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. If a vendor challenges the basis of this requirement, please email technical capability statement (formats for submission: PDF or MS Word) to Koffi Alognon at koffi.e.alognon.civ@health.mil . Closing date for challenges is no later than 08:00 AM ET on 17 April 2026. No phone calls will