Notice of Intent-specimen_processing.pdf

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT)

SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT

PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute of Health (NIH), Office of Acquisitions and Logistics Management (OALM), Office of the Director (OD) on behalf of the National Heart, Lung and Blood Institute (NHLBI) intends to negotiate and award a purchase order without providing for full and open competition to University of Maryland Medical Center, 250 West Pratt St, 24TH Floor, Baltimore, MD 21201 USA for Laboratory processing of peripheral blood obtained from patients with acute respiratory distress syndrome (ARDS) or other forms of respiratory failure on venovenous extracorporeal membrane oxygenation (VV-

ECMO).

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 621511 - Medical Laboratories, Small Business Size, $41.5 Million.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01 effective date 03-13-2026.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13— Simplified Acquisition Procedures at an amount not exceeding the SAT.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold.

Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements.

DESCRIPTION OF REQUIREMENT

Background The National Heart, Lung and Blood Institute (NHLBI) has an area of focus on laboratory processing of peripheral blood obtained off-hours (Monday through Friday

5PM -5AM, weekends and holidays) from patients with acute respiratory distress syndrome (ARDS) or other forms of respiratory failure on venovenous extracorporeal membrane oxygenation (VV-ECMO). Specimen processing will include centrifugation of peripheral blood samples for collection of plasma, red blood cell depletion of peripheral blood mononuclear cells (PBMC), cell counting, and cryopreservation of samples prior to courier to NIH for storage. Specimen processing and handling has to occur immediately to preserve sample integrity for downstream gene and protein analysis.

Specimen handling and processing will occur in the UMMC Laboratory of Pathology, under the direction of Dr. Robert Christenson.

Purpose and Objectives The purpose of this acquisition is to procure a contract for laboratory processing of peripheral blood obtained from patients with acute respiratory distress syndrome (ARDS) or other forms of respiratory failure on venovenous extracorporeal membrane oxygenation (VV-ECMO).

Period of Performance Base Period: 9/30/2026 to 4/30/2027

Project Description Scope of Work

Contractor Requirements:

Laboratory processing of peripheral blood obtained off-hours (Monday through Friday 5PM -5AM, weekends and holidays) from patients with acute respiratory distress syndrome (ARDS) or other forms of respiratory failure on venovenous extracorporeal membrane oxygenation (VV-ECMO). Specimen processing will include centrifugation of peripheral blood samples for collection of plasma, red blood cell depletion of peripheral blood mononuclear cells (PBMC), cell counting, and cryopreservation of samples prior to courier to NIH for storage. Specimen processing and handling has to occur immediately to preserve sample integrity for downstream gene and protein analysis.

Evaluation of the Contractor The NHLBI Clinical Director will evaluate the performance of the Contractor. The NHLBI Clinical Director may request reports and performance evaluations from the Contractor to assess its overall qualifications and expertise.

Location of Services University of Maryland Medical Center 250 West Pratt St, 24TH Floor

Baltimore, MD 21201

Other Important Considerations None

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION

(INCLUDING BRAND-NAME) DETERMINATION

Funding for the research that will be completed with the patient samples obtained through this contract is from the 2024 Bench-to-Bedside Award program to our lab (Torabi-Parizi, Laboratory of Basic and Translational Immunology). This award was based on a research proposal that specified the University of Maryland Medical Center (UMMC) as the sole clinical collaborator. Therefore, to maintain the integrity of our research plan, protect patient confidentiality, and adhere to the proposed work that received funding, we must limit competition for this project.

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. 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 Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) https://sam.gov .

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. 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.

All responses must be received by 09/07/2026 at 10:00am EDT. Responses must be submitted via email to James Hawkins james.hawkins3@nih.gov and Lynn Furtaw lynn.furtaw@nih.gov.

All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.

https://sam.gov/