Sole Source for Plasma EDTA Specialized Testing for Laboratory Medicine

The National Institutes of Health (NIH) intends to award a fixed priced purchase order on a sole source basis to Mayo Collaborative Services Inc., Rochester, MN , 55905, UEI: JWSMJMBLTN44  for testing services needed to support a clinical research study. Mayo Collaborative Services offers Test Code CERAM.  Mayo test CERAM is useful for evaluating the risk of major adverse cardiovascular events within the next 1 to 5 years, this testing is not performed in the Clinical Center Department of Laboratory Medicine (DLM) laboratory. Mayo is the only known US vendor that performs this specific testing. A base and four option years is contemplated for this requirement.

The NIH has a clinical research trial that was IRB approved in June, 2022. The primary objective of the study is to examine associations between diet and the gut microbiome. A secondary objective is examining the associations between the gut microbiome and circulating metabolites. Mayo, is a CLIA- and NPI-certified laboratory. Mayo is currently used by the NIH CC for clinical testing, due to an existing contract for reference laboratory testing with the lab. Some testing on study patients will be performed through the routine hospital process which routes samples through the Mayo reference desk. Collaborators on the study are using Mayo laboratory for testing and there is a need to compare assay results across the various research studies. Also  current research samples have already been tested using Mayo Collaborative Services and consistency is needed to limit testing variability for accuracy of results.

This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b)(i), Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. The total dollar value of this purchase order shall not exceed the SAT at $250,000.00.

Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Each response should include the following Business Information:

a. DUNS.

 b. Company Name, address, POC, Phone and Email address

c. Current GSA Schedules or NAICS codes appropriate to this Award.

d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System for Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1

e. Capability Statement

Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice