WRAIR - Diagnostics and Countermeasures Branch (DCB) Support Services

Background
The solicitation is for the provision of operational, scientific, medical, technical, and administrative services to support the Walter Reed Army Institute of Research (WRAIR), Diagnostics and Countermeasures Branch (DCB) in executing clinical service delivery for US military personnel, and translational/applied research for generation of Knowledge Products and diagnostic countermeasures that inform response to and management of P and E pathogens of US Military and National Security interests. The performance under this contract involves work within Biosafety level two (BSL 2) laboratories; and may, in the future, involve work in BSL three (BSL 3) laboratories. Individuals may be exposed to bio-hazardous materials, and infectious human and animal specimens including blood, sera, plasma, cells, cerebral spinal fluid, tissue, respiratory secretions containing known and unknown pathogens.

Work Details
The contract includes various tasks/services such as laboratory operations, clinical/applied research, administrative support, surge laboratory operations, surge clinical/applied research, information technology services, short suspense specified protocols for RDT&E and O&M purposes.

The offeror is required to submit a Technical Volume which demonstrates a clear understanding of the PWS requirements including execution of clinical screening, translational research for evaluation of new/novel products for Premarket Approval (PMA), Quality Management Plan approach addressing compliance requirements for high complexity testing and integration of Quality System Essentials (QSEs), experience in high complexity clinical testing of human and animal specimens, corporate experience supporting clinical trials/studies in support of manufacturer Pre-market Approval (PMA), Emergency Use Authorization submissions for approval and licensure of assays and platforms through FDA submission process.

The offeror is also required to submit a Past Performance volume with no more than three references of relevant contracts within the past 3 years for its own performance.

Period of Performance
The period of performance is from 01-SEP-2023 to 31-AUG-2025.

Place of Performance
The contract will be performed at WALTER REED - 503 ROBERT GRANT AVE SILVER SPRING, MD DC 20910.