75N98026Q00454_CSS_0002.docx

COMPETITIVE COMBINED SYNOPSIS/SOLICITATION

INTRODUCTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

The solicitation number is 75N98026Q00454. This solicitation is issued as a competitive combined synopsis/solicitation for commercial products or commercial services. The Government intends to award a contract or purchase order resulting from this solicitation using full and open competition.

This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 334516 with a Size Standard of 1000.

REGULATORY AUTHORITY

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

· This requirement is unrestricted.

DESCRIPTION OF REQUIREMENT

The National Institute of Mental Health (NIMH), Molecular Imaging Banch (MIB), requires two (2) Hematology for the facilitation of standardized hematology testing that directly supports MIB protocols and PET radioligand programmatical objectives by enabling rapid safety minitorung and improving stidy execution, data quality, and operational quality.

The Hematology Analyzer must be able to provide reliable, rapid, on site hematolgy testing to support the following objectives:

i. Enable on-demand complete blood count (CBC) testing (and associated differentials/indices as configured) to monitor hematologic status in research subjects involved in PET radioligand studies.

ii. Support safety monitoring and eligibility assessments for PET radioligand development workflows where blood cell parameters are critical (e.g., baseline screening, longitudinal monitoring, and post-procedure follow-up).

iii. Reduce turnaround time and logistical risk associated with off-site testing (sample degradation, scheduling constraints, and delays that can compromise time-sensitive PET study timelines).

iv. Improve data quality and continuity by standardizing hematology measurements under controlled, on-site procedures aligned with study documentation and quality requirements.

SALIENT CHARACTERISTICS

The analyzers must meet or be comparable to the following requirements:

· 5-part differential CBC capability (minimum reportable menu)

· Ability to perform automated hematology testing that includes CBC parameters and a 5-part WBC differential with reportable results including the following:

· WBC, RBC, HGB, HCT, RBC indices (MCV, MCH, MCHC, RDW-SD, RDW-CV), platelet parameters (PLT, MPV), and differential counts/percentages (LY, MO, NE, EO, BA with # and %)

· Throughput suitable for low- to mid-volume, time-sensitive workflows

· Ability to process, at minimum, 60 samples per hour to support PET radioligand study schedules and rapid same day decision making

· Low sample volume requirement to support micro-collection workflows

· Abillity to accept micro-collected whole blood between ~10 to ~15 µL sample volume (and provide a pre-dilute option requiring ~20 µL) to minimize blood draw burden and enable flexibility across research populations.

· Provide features that maximize uptime and reduce operator burden, including built-in reliability and automatic start-up functions to support continuous readiness for PET study days.

· Include Reagent management supporting continuity and cost control

· Use a simplified reagent approach (three reagents) with features that support efficient replacement and tracking (e.g., barcoding and software tracking) to maintain consistent performance over the instrument lifecycle.

· Data handling, specimen identification, and connectivity

· The system shall include a touchscreen user interface and barcode capability to reduce transcription errors and support sample traceability; it shall provide a bi-directional LIS interface to enable electronic results transmission and auditable workflows (as applicable to the laboratory environment).

· Custom integration with current in use Beckman Coulter hematology systems and workflows.

· Small footprint / integrated computing suitable for constrained bench space

· The analyzer shall have a compact design suitable for limited laboratory bench space and include an integrated computer/workstation design (or equivalent) to minimize ancillary hardware needs.

· Reagents shall be cyanide-, azide-, and formaldehyde-free (or equivalent) to reduce disposal burden and improve safety posture in the laboratory.

· Software license valid during the operational life of the instrument, warranty of at least one year.

The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition. Add any agency-specific instructions as required.

The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation represents the best value to the Government, price and other factors considered.

Evaluation Factors:

(Include relative importance of factors if required.)

A written notice of award or acceptance of an offer, issued within the time specified in the offer, shall result in a binding contract without further action by either party. The Government reserves the right to accept any offer before the expiration date.

Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, with their offer.

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

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items, applies to this acquisition.

Additional contract requirements or terms and conditions, as determined necessary by the Contracting Officer and consistent with customary commercial practices:

(Insert if applicable; otherwise state “None.”)

The Defense Priorities and Allocations System (DPAS) is (applicable / not applicable).

SUBMISSION REQUIREMENTS

Responses to this synopsis must include sufficient information to demonstrate the offeror’s bona-fide capabilities for fulfilling the required product or service. Responses must include, at a minimum:

· Unit and total price

· Shipping and handling costs

· Delivery period after award

· Delivery terms

· F.O.B. point (destination or origin)

· Product or catalog numbers (if applicable)

· Product/service description

Additional evaluation considerations may include past performance, warranty, lifecycle cost, maintenance availability, and environmental or energy efficiency.

Responses must include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received by June 16, 2026 at 5:30 pm EDT, ) and must reference solicitation number 75N98026Q00454. Responses must be submitted via the SAM.gov webportal. Potential Offerors do not need to register to view a notice; however, in order to submit questions and/or response to this Notice, an account will need to be established.

(The NIH is not responsible for any electronic transmission, or mail failures, resulting in failed or late quotes).

POINT OF CONTACT:

Brittany May Contract Specialist Brittany.may@nih.gov

07/18