Notice Type: Special Notice of Intent to Sole Source This is a SPECIAL NOTICE ANNOUNCEMENT ONLY. The Department of Veterans Affairs, VISN 9, Department of Veterans Affairs, VISN 9, VA Tennessee Valley Healthcare System located at 1310 24th Avenue South, Nashville TN 37212 has a requirement for specialized genetic blood test for veteran patients who have undergone heart transplant surgery and intends to award a sole source contract to CAREDX Inc., 3260 Bayshore Boulevard, Brisbane CA. 94005. This proposed contract action is for the procurement of heart transplant reference lab services for the post-transplant patient to determine if they are in rejection status. CareDx Inc., is the only reference laboratory service testing that provides AlloMap Molecular Expression Tests. This a specialized genetic blood test for veteran patients who have undergone heart transplant surgery. The test determines if a heart transplant patient has a stable transplant and is not rejecting the heart. This FDA approved blood test replaces heart biopsies to determine rejection status. This contract is to be in effect no later than September 1,2022 and will expire August 31, 2023. The base period of performance is for a base year of 09/01/2022 thru 08/31/2023 and four (4) option years with only one source, CareDx Inc., under the authority Federal Acquisition Regulation (FAR) Part 13.106-1(b)(1). CareDx Inc. is the only reference laboratory service testing that provides AlloMap Molecular Expression Test. This a specialized genetic blood test for veteran patients who have undergone heart transplant surgery. The test determines if a heart transplant patient has a stable transplant and is not rejecting the heart. This FDA approved blood test replaces heart biopsies to determine rejection status. CareDx is the only identifiable sole source for this requirement of heart post-transplant veterans. CareDx is the only Reference Lab using this test. Response: Responses to this Special Notice should be able to demonstrate the firm's ability, capability, and responsibility to deliver the service listed above. The purpose of this Special Notice announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HUBZone and other Small Businesses interested and capable of providing the services described above. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. No funds have been authorized, appropriated, or received for this effort. Responses should include the following information: Business name, address, business size and Socioeconomic Category (HUBZone, 8(a), Service-Disabled Veteran, Small Business, Large Business, etc.), and point of contact to include e-mail address and telephone number. All offerors must be registered in the System for Award Management (www.sam.com) and Representations and Certifications must be completed prior to any future award. Supporting evidence must be furnished in detail to demonstrate the ability to provide the full maintenance and repair service on equipment listed. Determination by the Government not to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Important information: The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this Special Notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. No sub-contracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 621511 MEDICAL LABORATORIES. Any offeror capable of providing this service shall notify the Contracting Officer by email within 7 calendar days from the date of the publication of this special notice. *Responses must include written documentation from CareDx Inc. showing your company is an authorized service provider for AlloMap Molecular Expression Tests. All information is to be submitted via email no later than 1:00 PM EST, June 9th, 2022, to:
[email protected].