Q301 | NOI Heart and Kidney Transplant Rejection testing
ID: 36C26125Q0170Type: Special Notice
Overview

Buyer

VETERANS AFFAIRS, DEPARTMENT OFVETERANS AFFAIRS, DEPARTMENT OF261-NETWORK CONTRACT OFFICE 21 (36C261)MATHER, CA, 95655, USA

NAICS

Medical Laboratories (621511)

PSC

MEDICAL- LABORATORY TESTING (Q301)

Original Source

https://sam.gov/opp/e0a65b5c65a94c25949b0817b0e35f26/view
Timeline
    Description

    The Department of Veterans Affairs (VA) intends to negotiate a Sole Source Award with CareDX, Inc. for heart and kidney transplant rejection testing, as outlined in their Special Notice. The VA Palo Alto Health Care System (VAPAHCS) requires specific post-transplant testing services that only CareDX can provide, including Allosure Kidney and AlloMap Heart blood tests, which are crucial for monitoring transplant rejection and minimizing the need for invasive biopsies. This initiative underscores the VA's commitment to enhancing patient care for veterans while adhering to health regulations and standards. Interested parties may direct inquiries to Gary Christensen at gary.christensen@va.gov, as this notice is not a formal solicitation and no proposals will be accepted unless compelling evidence for competition is presented.

    Point(s) of Contact
    Gary Christensen
    (650) 493-5000 x65825
    Gary.Christensen@va.gov
    Files
    Title
    Posted
    CareDX AlloMap Allosure Heart and kidney SOW DRAFT.pdf
    The VA Palo Alto Health Care System (VAPAHCS) seeks to establish an Indefinite Delivery Indefinite Quantity (IDIQ) contract for specialty laboratory services focusing on post-heart and kidney transplant testing. The contract will provide Allosure Kidney, AlloMap Heart, and AlloSure Heart blood tests to monitor transplant rejection and ensure the stability of organ transplants in veteran patients, thus reducing the need for invasive biopsies, which carry inherent risks. The contractor must supply necessary testing materials and possess required licenses, permits, and certifications. The contract spans five years with specified quantities of tests per year, requiring compliance with health regulations and standards as set out by the CDC and the Clinical Laboratory Improvement Act (CLIA). Additionally, protocols for reporting results, sample preparation, and compliance monitoring are outlined, emphasizing data protection and secure handling of sensitive patient information. This initiative reflects the government's dedication to enhancing transplant patient care while minimizing invasive procedures and ensuring health safety standards are rigorously followed.
    NOI CAREDX INC Heart Kidney Transplant Testing.pdf
    The Department of Veterans Affairs (VA) has issued a Special Notice announcing its intent to negotiate a Sole Source Award with CareDX, Inc. for heart and kidney transplant rejection testing under the Federal Acquisition Regulation (FAR) 6.302-1. The notice indicates that the VA Palo Alto Health Care System (VAPAHCS) requires specific post-transplant testing, which only CareDX can provide. The contracting details specify the service codes, including Product Service Code Q301 for Medical Reference Laboratory Testing and NAICS code 621511 for Medical Laboratories. This Notice of Intent is not a formal solicitation and no proposals will be accepted. Any interested parties must provide substantial justification for competition to be considered, reflecting on whether it would benefit the government. The contract is expected to proceed unless compelling evidence suggests otherwise. The document emphasizes direct communication with the designated Contract Specialist, Gary Christensen, for any inquiries regarding this notice. The outcome of this process will ultimately depend on the government's discretion.
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    Q301 | NOI Heart and Kidney Transplant Rejection testing
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