Ortho-Clinical Diagnostics Open Market items on FSS

The Defense Health Agency intends to award a delivery order against Federal Supply Schedule (FSS) contract, V797D-60637, pursuant to the authority of the Multiple Award Schedule Program. The Defense Health Agency intends to negotiate on a sole source basis in accordance with (IAW) FAR 8.4 with Ortho-Clinical Diagnostics Inc., 1001 US Hwy 202, Raritan, NJ, 08869-1424.
The proposed acquisition is a firm fixed price cost per test delivery order.

Hematology Vision Analyzer Cost Per Test used to rapidly analyze whole blood specimens for the complete blood count.
Items being purchased in this acquisition: An automated blood bank analyzer is needed which performs the full range of immunohematology testing, including crossmatches, cell panels, antigen testing and serial dilutions for titration studies. The analyzer must automate blood bank test processes including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading and interpretation.
System must use column agglutination technology.
Instrument must be capable of fully automated serial dilutions.
Testing system must not utilize proprietary system liquids.
Instrument must offer up to 24 hours walkaway time.
When operational, the instrument must always be in a ready mode and at no time go into a hibernation or sleep state.
Testing system must have capability for a minimum of three pre-diluted antibody identification panels that are FDA cleared for use in conjunction with the instrument.
Instrument must be able to run selected antibody identification panels.
Supplier's pre-diluted reagent red blood cells must utilize United States based donors. Reagent red blood cells and column agglutination technology cards must use United States based manufacturing.
Vendor must supply an analyzer capable of bench top installation.
Instrument system must have a pipette conditioning (e.g. dead) volume <20 l.
Vendor must have a demonstrated ability to supply automated and non-automated FDA licensed reagents for blood bank or transfusion service testing under their own brand.
Vendor must have FDA approval for an automated confirmatory testing to include rare anti sera including E,e, C,c, JKa,JKb, FYa,FYb, S,s, N, P1, Lea, Leb, K, and weak D.
Fully loaded waste containers shall each not weigh more than 11 lbs. and be accessible at waste height.
Optical resolution of the on-board camera must be at least 5 megapixel resolution down to 32 x 32 microns, and store a digital image of both the front and back of each gel card to record test results.
System must have capability to interface to the laboratory information system (LIS).

Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/systems such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The system shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA, with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

This acquisition is being conducted under FAR 8-4 Federal Supply Schedules. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System 334516 with a Small Business Size Standard of 1000 employees. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, companies who believe they can provide the requirement described above may submit technical data, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification of this notification will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Any information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

This contract is estimated at $189,129.92 with open market items valued at $36,165.48 (base and two options)

The Open Market items being purchased in this acquisition are as following and are the only components being advertised under this notice:

0.8% AFFIRMAGEN (2 x 10mL)
Part Number: 719201
QTY: 78
Manufacture: Ortho-Clinical Diagnostics

0.8% SURGISCREEN (3 X 10mL)
Part Number: 6902316
QTY: 78
Manufacture: Ortho-Clinical Diagnostics

ALBA Q CHECK SIM WHOLE BLOOD CONTROLS
Part Number: Z498
QTY: 52
Manufacture: Ortho-Clinical Diagnostics

Capability statements shall be submitted by email only as a MS word or Adobe PDF attachment to jan.t.harding.civ@health.mil. Statements are due no later than 1:00 PM Eastern time on 22 February 2024. NO PHONE CALLS ACCEPTED.