Q301--Research Lab Services - Analysis of Analytes for Skeletal Health in Diabetes Pre-Solicitation Notice with Intent to Sole Source 36C24E25Q0069

Pre-Solicitation Notice for notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source contract for a 12-month base period with MaineHealth, a regional nonprofit health care system located at 110 Free St, Portland, ME 04101 to obtain analysis of specialized research laboratory analytes on study samples to support the San Francisco VA Healthcare System (SFVAHCS) research study Bone marrow fat and skeletal health in type 2 diabetes . The study observed Veterans with type 2 diabetes to improve blood sugar control and assessing skeletal outcomes. A specialized research lab is needed to provide advanced analyses of hormones and analytes that are related to skeletal health and bone marrow adiposity. The service required is the analysis of serum & plasma specimens for hormone (IGF-1, Testosterone, Estradiol, Sclerostin, Adiponectin, Leptin, pentosidine, carboxymethyl lysine) and biochemical bone turnover marker levels (CTX, P1NP, TRAcP5b). The specific analyses in this research study require a specialized lab to perform the analysis of subject specimens for the primary outcome of the study. Analyses must be performed at a specialized research laboratory to ensure high standards of accuracy, sensitivity, and reproducibility. These complex assays require advanced instrumentation that are only available in dedicated research settings. A specialized laboratory is needed to ensure analyses are performed by experienced scientists who understand the nuances of biological variability and assay limitations, which is essential for the scientific rigor of the findings. The MaineHealth research institute is led by an internationally recognized physician-scientist in endocrinology and skeletal biology. The laboratory is known for its accurate and reproducible data suitable for publication and grant submission. MaineHealth is the only vendor that can provide the specialized research services required. Since the intent is to procure this on a sole source basis, no solicitation will be posted to Contract Opportunities on SAM.gov. The applicable NAICS code is 621511 with a $41.5 MIL size standard. The PSC is Q301. The authority for this action is FAR 6.302.1-1 Only One Responsible source and no other supplies or services will satisfy agency requirements. Interested persons may contact the Contracting Officer via email at annmarie.stewart@va.gov regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer.