Biospecimen Core Resource (BCR)   3

Background
The Office of Acquisitions of the National Cancer Institute (NCI), National Institutes of Health (NIH), seeks to establish a Biospecimen Core Resource (BCR) to provide excellence in biospecimen and data management services in support of NCI research.
The BCR will facilitate research through the collection and distribution of biospecimens from a diverse participant population recruited at multiple medical institutions throughout the U.S., managing protocols from collection kit assembly to receipt, processing, storage, and distribution, in close collaboration with NCI and project stakeholders.

Work Details
The Contractor shall independently furnish all necessary services, qualified personnel, material, equipment, and facilities to: assemble and ship biospecimen collection kits; receive and track inbound kits; accession biospecimens including CLIA-accredited accessioning; process biospecimens upon receipt (including CLIA biospecimen processing), perform histology and pathology review; process specimens into molecular analytes with quality control; store biospecimens and molecular derivatives; and distribute biospecimens to research laboratories.
Contractor shall develop and implement a Project Management and Communication Plan, a Quality Assurance and Quality Control Plan compliant with CLIA and CAP BAP standards, Standard Operating Procedures and a Laboratory Manual; submit electronic deliverables including Monthly, Quarterly, Annual, Draft Final and Final Task Order Reports and data compliant with Section 508; maintain a Laboratory Information Management System to manage specimen lifecycle data; provide system security and continuity; and execute final transition planning.

Period of Performance
September 1, 2022 through August 31, 2027

Place of Performance
Contractor's Biospecimen Core Resource facility and associated CLIA-certified laboratory, in collaboration with Biospecimen Source Sites at multiple medical institutions throughout the United States, with specimen distribution to laboratories nationwide.

Bidder Requirements
Offerors must propose a CLIA-certified laboratory; hold accreditation under the College of American Pathologists Biorepository Accreditation Program (CAP BAP); maintain Bio-safety Level 2 (BSL-2) certification; employ key personnel including a Principal Investigator with biobanking experience and a board-certified pathologist; demonstrate trained laboratory and IT staff; develop and maintain QA/QC Plan and SOPs compliant with CLIA and CAP standards; and provide a System Security Plan in compliance with FISMA Low requirements.