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This Pre-Solicitation opportunity from Department Of Health And Human Services was posted on March 24, 2021. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

THERAKOS CELLEX Photopheresis SYSTEM Procedural Kits for Transfusion Medicine

Closed
21-005432Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

Active Opportunities Like This One

NAICS: 325413
New
Federal
Cost Per Reportable Result Purchase of Immunohistochemistry Reagents for Laboratory Tests.
Solicitation # 36C26027Q0058
The Department of Veterans Affairs, through Network Contracting Office 20, is seeking a comprehensive histology staining workflow system for the Puget Sound Health Care System in Seattle, Washington. The required system must include two immunohistochemistry and two in-situ hybridization immunostainers, two special stainers, and an integrated specimen tracking system to ensure patient safety, maintain a chain of custody, and monitor productivity. The workflow components must be fully automated, communicate with one another, and maintain compatibility with Data Innovations middleware as well as VISTA, Cerner, and any future electronic health record systems acquired by the VA. The contract follows a Cost Per Reportable Result pricing model and spans a base year from February 1, 2027, to January 31, 2028, with four subsequent one-year option periods extending through January 31, 2032. Technical requirements specify that the immunostainers must perform 100% of tests listed in the provided specifications and support simultaneous IHC, ISH, and Direct Immunofluorescence staining. Equipment must support Code 39 and Code 128 barcodes, include a safe hazardous waste removal system, and be provided with an uninterruptible power supply capable of supporting a 15-minute controlled shutdown. The contractor is responsible for the delivery, installation, and removal of equipment at no additional charge and must guarantee a minimum equipment uptime of 98%. Performance and method validation must adhere to CLSI guidelines and College of American Pathologists standards. Additionally, the contractor must comply with strict federal and VA information security directives, including those regarding data confidentiality and media sanitization. Emergency supply orders must be fulfilled within 24 hours of a verbal request, providing enough consumables for one week of normal operation.
260-NETWORK Contract Office 20 (36C260)

POSTED

2 days ago

DEADLINE

in 23 days
NAICS: 325413
New
Federal
6550--HEMOCHRON SIGNATURE ELITE REAGENTS AND SUPPLIES
Solicitation # 36C26227Q0046
The Department of Veterans Affairs, Network Contracting Office 22, is conducting a sources sought notice for the procurement of FDA approved reagents, supplies, consumables, and quality control materials for Werfen Hemochron Signature Elite instruments. This requirement supports the Pathology and Laboratory Medicine Service at the Southern Arizona VA Health Care System in Tucson, Arizona. The contract structure includes a base year from January 1, 2027, to December 31, 2028, followed by four subsequent option years extending through December 31, 2032. The selected contractor must provide 24/7 technical and product support at no additional cost and ensure all items are fully compatible with existing instrumentation without requiring workflow changes or retraining. Key operational requirements include strict adherence to manufacturer specifications for packaging and temperature control during transport. All supplied materials must maintain a minimum shelf life of 90 days, and shipments must clearly list lot numbers and expiration dates. Standard orders are required to be delivered within four working days, while emergency deliveries for defective or temperature-compromised items must be completed within 24 hours of a verbal order. This procurement is conducted as a brand name or equal acquisition under FAR 52.211-6. Interested respondents must provide their business size status, SAM.gov identifiers, and evidence of compliance with the Buy American Act and the Non-Manufacturer Rule.
262-NETWORK Contract Office 22 (36C262)

POSTED

3 days ago

DEADLINE

in 13 days

General Info

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

Bethesda, MD, 20814, USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

PhaseClosed
Posted

Presolicitation

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc
Contacts2 people available
OfficeBETHESDA, MD, 20892, USA

Full Description

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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 (NIH), Clinical Center (CC) intends to award a one year fixed price purchase order to Therakos at Mallinckrodt, Hampton, NJ 08827 on a sole source basis to procure THERAKOS CELLEX Photopheresis SYSTEM Procedural Kits, CLXUSA for extracorporeal photopheresis therapy to patients post stem-cell transplantation on the existing government owned THERAKOS CELLEX Photopheresis System Instrument. This purchase is required for the analysis of patients with confirmed acute graft-versus-host disease per protocol 15-C-0039. Extracorporeal Photopheresis (ECP) is a recognized therapy for graft-versus-host disease (GVHD) post stem cell transplantation, particularly the steroid-refractory patient population. Under protocol 15-C-0039, ECP is delivered at a strategic time-point in patients therapy. Typically this therapy is in conjunction with other acute GVHD modalities. The goal of this treatment is to contribute to the patient's transition from an acute inpatient therapy to outpatient maintenance therapy. Only one known vendor has been identified for the purchase of 5 cases of the THERAKOS CELLEX'Procedural Kits-CLXUSA . Therokos Inc. is the sole registered trademark holder and manufacturer of the required product. If this specific product is not received, patients could be potentially harmed, causing an increased risk for post-stem-cell transplant complications, infection and death. The option to ectend quantity clause 52.217-6 applies to this requiement. The total value of the contract for one year shall not exceed $250,000.00. This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b). 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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