Clinical Protocols Administrative Service

PRE-SOLICITATION NOTICENOI-RML-D-1980785NAICS - 561110This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH), Laboratory of Clinical Immunology and Microbiology (LCIM), intends to negotiate on an other than full and open basis with Mary Garofalo (Contractor) to conduct two (2) professional protocols; the first protocol, designed for the screening and baseline assessment of and collection of research sample from patients with abnormalities of immune function as manifested by recurrent or unusual infections, recurrent or chronic inflammation, or previous laboratory evidence of immune dysfunction. Contractor will collect medical records and pathology slides/reports from patients and external medical providers and assemble them in a standardized format to facilitate the NIH physicians in the process of assessment for enrollment of patients to NIH clinical protocols. Contractor

will help schedule the collection of samples from patients that are required for enrollment or conduct of clinical protocols. Contractor will access some of the data through NIH systems like CRIS to monitor acquisition of data on patients enrolled in clinical studies.The mission of the Laboratory of Clinical Immunology and Microbiology (LCIM) includes both clinical trials and basic laboratory research. Clinical trials include studies of the natural history of primary immunodeficiency diseases as well as treatment of patients with these diseases using gene therapy, allogeneic transplantation using matched-sibling donor or matched-unrelated donor (MUD) hematopoietic stem cell grafts, as well as other novel approaches to improve human health.This individual is the only capable source based on specialized knowledge possessed by vendor to access the information and collate it in the format needed to complete the task. This requires intimate familiarity with the patient disease group of the study and materials needed to assemble it, familiarity with the protocol under which LCIM will be obtaining and receiving samples, and knowledge to perform the logistics set up for this and the steps to accomplish the required task.The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-RML-D-1980785) to Dana Monroe at dana.monroe@nih.gov, by 8:00 Am eastern standard time Monday, August 26, 2019. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.