SAMDaily.us | PRESOL | 65 | CareDx Lab/ 22x AlloSeq Tx17 kits.

SAMDAILY.US - ISSUE OF JUNE 17, 2021 SAM #7138
SOLICITATION NOTICE

65 -- CareDx Lab/ 22x AlloSeq Tx17 kits.

Notice Date: 6/15/2021 6:18:24 AM
Notice Type: Presolicitation
NAICS: 325413 — In-Vitro Diagnostic Substance Manufacturing
Contracting Office: NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
ZIP Code: 20892
Solicitation Number: 21-007406
Response Due: 6/29/2021 6:00:00 AM
Archive Date: 07/14/2021
Point of Contact: Grace Wong-Darko, Phone: 3014961199
E-Mail Address: Grace.Wong-Darko@nih.gov
(Grace.Wong-Darko@nih.gov)
Description: INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to: CareDX Lab Solutions INC. 901 S Bolmar St. STE. R. West Chester, PA, 19382-4550 NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code ��325413 with a Size Standard 1250. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-05, March 10, 2021. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: CareDx Lab/ 22x AlloSeq Tx17 kits. 2. Background Information: �The National Institutes of Health (NIH) is the nation�s foremost federally funded biomedical research institution.� It is comprised of twenty-seven Institutes and Centers.� The NIH Clinical Center (CC) is the onsite hospital for the NIH campus, providing full support for clinical studies in inpatient and outpatient settings.� The NIH CC is an 870,000 square-foot facility with the capacity to serve 240 inpatient beds and 82 day-hospital stations. The function of the Human Leukocyte Antigen Laboratory (HLA) of the Department of Transfusion Medicine, CC is to (1) provide clinical diagnostic laboratory testing for patients in the Clinical Center to facilitate possible transplant or enrollment into an appropriate protocol for the patient�s particular condition; (2) to conduct clinical consultations for Clinical Center physicians in the management of patient care in regards to potential transplant scenarios; (3) to maintain accreditation through various accrediting agencies in order to provide quality results (4) to conduct research in the development of new diagnostic laboratory tests (5) to facilitate the support and development of protocols which involve HLA testing and the implications for patient care. 3. Purpose or Objective: This Contract is to provide Next Generation Sequencing (NGS) reagents to the HLA Lab on an �as needed� basis.� CareDx (vendor) will ship 11 kits on 08/01/2021 and the laboratory will contact the vendor when the remaining 11 reagent kits are required. 4. The Vendor will supply reagents as needed in a timely manner for the period of performance, which is August 1, 2021 � July 31, 2022. �Shelf Life-Minimum � reagents should have a shelf life of 1 year when possible.� If only shorter dates are available, the HLA Lab will be contacted prior to shipment.�� The reagents include but not are not limited to those listed below: Description�� Quantity�� ASTX17.1(24)-RUO� AlloSeq Tx17�� 22�� Dry Ice�� 1�� Gel Packs�� 1�� Shipping�� 2�� The Vendor shall supply technical support for all reagents and their performance characteristics at no additional cost to the Government. Period of Performance The performance period for this contract will be August 1, 2021 to July 31, 2022. Delivery Schedule The HLA Lab shall request reagents by contacting the sales department directly and referencing the Purchase Order (PO) number.�� Kathleen Barracchini, Nuri Cha or Sarah Franks will be the ordering personnel. These reagents will be shipped overnight delivery Monday through Thursday to: �� DTM/HLA Lab Bldg 10, Room 1C744 9000 Rockville Pike Bethesda,� MD� 20892 -Shipping charges will be billed to the PO. -The contractor shall bear the cost of replacement for reagents found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments. Government Responsibilities The HLA Lab shall inspect shipments upon receipt and report any damage, defects or errors in shipment to the contractor.� CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This system is on site and has been validated for use on CC patients. �It would be detrimental to the government to attempt to change systems and quite impossible as these instruments are proprietary and only distributed by CareDX Lab Solutions Inc. �With the continuation of using the same system will also help reduces the risk of a disruption in patient care. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. CLOSING STATEMENT 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 a technical proposal, a cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), 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 June 29th, 2021, 9:00 AM Eastern time and must reference solicitation number 21-007406. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at Grace.Wong-Darko@nih.gov. Fax responses will not be accepted. ""All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.""
Web Link: SAM.gov Permalink
(https://beta.sam.gov/opp/adfec81661274c648630d1ddda05494b/view)
Place of Performance: Address: West Chester, PA 19382, USA; Zip Code: 19382; Country: USA
Record: SN06032558-F 20210617/210615230116 (samdaily.us)
Source: SAM.gov Link to This Notice
(may not be valid after Archive Date)

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65 -- CareDx Lab/ 22x AlloSeq Tx17 kits.