Notice of Intent-75N98026Q01143.pdf

Notice of Intent to Sole Source

Solicitation Number: 75N98026Q01143 Solicitation Type: Sole Source (Non-Competitive) Title: STEMvision™ Automated CFU Reader NAICS / Size Standard: 334516/ 1,000 employees

Introduction

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

AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN

COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to StemCell Technologies, Inc. to provide STEMvision™ Automated CFU Reader to the Division of Intramural Research in accordance with the following information.

Background Information

The Regenerative Therapies for Inherited Blood Disorders Lab at NHLBI currently performs Colony- Forming Unit (CFU) assays to assess the proliferation and differentiation potential of hematopoietic progenitor cells. Currently, these colonies are identified and counted manually using inverted light microscopy. This process is labor-intensive, requires highly specialized expertise, and is inherently prone to intra- and inter-observer variability, which can impact the reproducibility of critical research/clinical data. The purchase of the STEMvision™ system will standardize CFU assay analysis.

Purpose and Objectives

The purpose of this acquisition is to acquire STEMvision™ Automated CFU Reader for Regenerative Therapies for Inherited Blood Disorders Lab.

Contractor Requirements

The Contractor shall provide one STEMvision™ Automated CFU Reader addressing the following required characteristics:

• Provides "walk-away" imaging and automated counting of CFU assays in a 6-well plate format.

• Capable of imaging and analyzing a complete 6-well plate in approximately 5 to 10 minutes.

• Uses pre-validated algorithms for human or mouse hematopoietic assays to eliminate technician bias.

• Optimized for use with meniscus-free cultureware (e.g., SmartDish™) and specialized methylcellulose media (e.g., MethoCult™) to ensure image clarity.

• Provides a permanent digital record of the entire culture well for retrospective review and audit trails.

Sole Source Justification

STEMCELL Technologies Inc. is the sole manufacturer and proprietary developer of the STEMvision™ Automated CFU Reader, making it the only vendor capable of fulfilling this requirement. Standard colony counters and high-content imagers are engineered for 2D monolayers or bacterial agar and lack the specialized depth-of-field optics, multi-angle illumination, and lineage-specific algorithms required to image and classify 3D hematopoietic progenitor colonies (BFU-E, CFU-GM, and CFU-GEMM) suspended in viscous MethoCult™ semi-solid media. Procuring an alternative vendor's reader would introduce severe scientific and operational risks: non-specialized optics struggle with light refraction and meniscus distortion in methylcellulose, leading to misclassified lineages, dark-edge artifacts, and inaccurate potency counts. Furthermore, substituting an unvalidated reader would invalidate historical dataset continuity, breach protocol compatibility with gold-standard MethoCult™ reagents, and require months of costly manual algorithm re-validation, ultimately compromising data integrity and project timelines.

Regulatory Authority

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart

12.102 (a), restricting competition. 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.

FAR Clauses

The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services, applies to this acquisition.

The provision at FAR clause 52.212-2, Evaluation – Commercial Products and Commercial Services, is applicable. The Government will award a contract resulting from this notice to the offeror listed above. The following factors shall be used to evaluate the offer: The contractor shall demonstrate its ability to provide the services listed that meets the specifications provided above.

FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

FAR clause at 52.204-13 System for Award Management Maintenance, applies to this acquisition.

The provisions at FAR clause 52.203-17, Contractor Employee Whistleblower Rights, applies to this acquisition.

The provision at FAR clause 52.225-25, Prohibition on Contracting With Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications, applies to this acquisition.

FAR clause FAR 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, applies to this acquisition.

HHSAR clause 352.239-78, Information and Communication Technology Accessibility Notice

HHSAR clause 352.239-79, Information and Communication Technology Accessibility

HHSAR clause 352.232-71, Electronic Submission of Payment Requests

Additional Information

The North American Industry Classification System (NAICS) Code is 334516 and the Small Business Size Standard is 1,000 employees. This acquisition is being conducted under RFO FAR Part 12, Acquisition of Commercial Products and Commercial Services, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01 effective March 13, 2026.

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) www.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 September 10, 2026, at 12:00PM ED and must reference synopsis number 75N98026Q01143. Responses shall be submitted electronically to noelle.decenzo@nih.gov.

Responses will only be accepted if dated and signed by an authorized company representative. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

http://www.sam.gov/ mailto:noelle.decenzo@nih.gov