Blood typing reagents for transfusion medicine

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

The National Institute of Health, Clinical Center (CC) intends to award a fixed price purchase order with one (1) twelve month option period to BioArray Solutions Ltd, Norcross, Ga. 30071 on a sole source basis to procure reagents that has been quality controlled for use on the existing government-owned BioArray Imaging System (AIS) used to perform genotyping for RBC (Red Blood Cell) blood groups for the CC.

BioArray Solutions Ltd, is the sole manufacturer and trademark holder for the Bioarray TM, BeadChip TM select proprietary reagents to be used with the BioArray test platform, including the AIS reader and software to perform, analyze and report the genotype and predicted phenotype of red blood cell blood group antigens. The BioArray Beadchip assay platform is the only FDA 510K cleared assay for detecting blood group antigens using molecular methods necessary for personalized precision matching.

The comprehensive system of instruments and consumables is necessary to produce a complete typing result. The acquisition of these kits are vital to perform testing for antibodies and antigens in donor blood which is to be dispensed to patients who are also having their blood tested with these reagents for blood typing and matching. If blood testing is not performed accurately, the safety of the CC could easily be jeopardized. The following supply list is required.

Item# Description Quantity
800-00220-48 RHD Beadchip 6 x 8 slides / tests 3
800-00206-48 RHCE Beadchip kit 6 x 8; 48 tests/kit 3
800-20202-08 HEA 1.2 BeadChip (12x8) slide kits (IVD) 7
800-20236 Reag box, PreType BeadCheck Kit 2
800-20301 AIS Exposure Test Carrier 2

FAR 52.217-6, Option to Increase Quantity applies to this procurement. The purchase order shall not exceed the simplified acquisition threshold.

This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b)(i), 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. Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.
Each response should include the following Business Information:
a. DUNS.
b. Company Name, address, POC, Phone and Email address
c. Current GSA Schedules or NAICS codes appropriate to this Award.
d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1
e. Capability Statement

Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice.

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