Inactive

NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH20003928 TITLE: The Evaluation of Women with Perimenopause-Related Mood and Behavioral Disorders CLASSIFICATION CODE: Q -- Medical services NAI... NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH20003928 TITLE: The Evaluation of Women with Perimenopause-Related Mood and Behavioral Disorders CLASSIFICATION CODE: Q -- Medical services NAICS CODE: 621511 – MEDICAL LABORATORIES RESPONSE DATE: June 8, 2020 at 12:00 PM EST PRIMARY POINT OF CONTACT: Thien Nguyen Thien.Nguyen2@nih.gov Phone: 301-827-0914 DESCRIPTION: INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute of Mental Health (NIMH) intends to negotiate on a sole source bases with Lab Corporation of America, 358 S Main St Suite 458, Burlington, NC 27215-5837 NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 621511 – Medical Laboratories with a Business Size Standard of $32.5 million. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, 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 (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization). The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 20019-01 dated December 1, 2018. PURPOSE AND OBJECTIVES: Contractor will perform assays (laboratory tests) on clinical samples or specimens to determine levels of a particular hormone or chemical in these samples. These samples have been collected from study subjects in NIMH Section on Behavioral Endocrinology protocols. This protocol continues to enable us to ensure that the participants participating in related protocols are carefully diagnosed and longitudinally demonstrate the conditions or lack of conditions for which they are selected. DESCRIPTION OF REQUIREMENT LabCorp-Esoterix Laboratory is a core laboratory that will be responsible for performing assays (laboratory tests) on clinical samples or specimens to determine levels of a particular hormone or chemical in these samples. These samples have been collected from study subjects in NIMH Section on Behavioral Endocrinology protocols. The assays relevant to this Statement of Work involve the measurement of plasma levels of Estradiol, Testosterone, Androstenedione, Estrone, Androsterone, 11 Keto testosterones, Progesterone. Specifically, the LabCorp-Esoterix Laboratory will: maintain a continuous quality control program to ensure accuracy in their hormone assays; set-up to run assays for pediatric patients as well as adult patients and therefore can perform assays on very small quantities of plasma, which in our case is critical when there is limited plasma available for testing from some subjects; perform an additional extraction step on all steroid assays that produce more accurate results – this step is not available from most commercial labs; careful hand-batching of our study samples to maintain the assignment of subjects and controls in the same assay run – other commercial labs have repeatedly failed to attend to these batching needs, resulting in unusable data and ultimately in increased assay costs; ensure the limits of detection for hormone levels are more sensitive than those from other commercial labs, a quality critical in the field of gonadal steroid research; and ensure compatability with a previous set of samples from this study which have been measured at this facility and to maintain comparability within this study in the measures obtained. Thus, it is critical that have these present samples run within the same facility CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, LabCorp is the only vendor in the marketplace that can provide the services required by NIMH. The intended source is: Laboratory Corporation of America 358 S Main St Suite 458 Burlington, NC 27215-5837 CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), GSA Federal Supply Schedule (If available), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH20003928. Responses must be submitted electronically to Thien Nguyen, Contract Specialist, at thien.nguyen2@nih.gov. and Valerie Whipple, Contracting Officer, at valerie.whipple@nih.gov. U.S. Mail and fax responses will not be accepted.