SPECIAL NOTICE
Q -- Oncotype DX Prostate Testing
- Notice Date
- 2/21/2024 12:19:44 PM
- Notice Type
- Special Notice
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
- ZIP Code
- 76006
- Solicitation Number
- 36C25724Q0387
- Response Due
- 2/28/2024 8:00:00 AM
- Archive Date
- 03/29/2024
- Point of Contact
- Ognian Ivanov, Contract Specialist, Phone: 210-694-6302
- E-Mail Address
-
ognian.ivanov@va.gov
(ognian.ivanov@va.gov)
- Awardee
- null
- Description
- The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 17, intends to award a firm-fixed priced contract to MDxHealth for Laboratory Fee Basis Testing. MDxHealth SA has acquired Oncotype DX® GPS (Genomic Prostate Score® or GPS) test from Genomic Health, Inc., a subsidiary of Exact Sciences Corporation. The purpose of the resulting contract will be to provide a Blanket Purchase Agreement (BPA) for Laboratory Fee Basis Testing for MDxHealth Genomic Oncology Testing for the Amarillo VA Health Care System (ATVHCS), at 6010 Amarillo Blvd West Amarillo Texas 79119. Contractor is to provide healthcare resources in accordance with Public Law 104.262 and 38 U.S.C. 8153. SCOPE: The Amarillo VA Health Care System (VAHCS) and Pathology and Laboratory Medicine Service (P&LMS) located in Amarillo, Texas, requests a Vendor to perform services in the area of gene expression assay and Oncotype DX testing for cancers of the prostate. This specialized testing is beyond our scope of services to provide in-house. BACKGROUND: The use of the Oncotype DX test is a recommendation by the National Comprehensive Cancer Network (NCCN) that is followed by our former VISN 18 Hematologists and Oncologists counter parts. These tests aid in determining the next step to take in the treatment and prognosis of patients diagnosed with prostate cancer. The Oncotype DX GPS prostate cancer testing applies advanced genomic science to reveal the unique biology of a patient s tumor in order to optimize cancer treatment decisions. By providing answers to key questions about the aggressiveness of and appropriate treatment for early-stage cancer, our practice-changing tests help physicians and patients select the right treatment at the right time in each individual case. In this way, Oncotype DX GPS testing helps patients and their physicians to optimize their cancer care and outcomes, enabling many patients to avoid unnecessary procedures and therapies, and saving the healthcare system billions of dollars in unnecessary costs. TYPE OF CONTRACT: The AVAHCS intends to award a Firm Fixed Price, Indefinite Deliver Indefinite Quantity (IDIQ) contract. PERIOD OF PERFORMANCE The contract period of performance shall be a Base year and four (4) 1-year options. VENDOR RESPONSIBILITIES The vendor shall provide all personnel, equipment, tools, materials, supervision, other items and non-personal services necessary to perform gene expression assay, Oncotype DX testing as defined in the Performance Work Statement. The Vendor shall perform to the standards in this contract. The Vendor shall provide AVAHCS services for: ConfirmMDx testing- Prostate (CPT code 81551) SelectMDx testing - Prostate (PLA code 0339U) Oncotype DX GPS testing -Prostate (PLA code 0047U) The Vendor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The Vendors quality control program is the means by which he assures himself that his work complies with the requirement of this contract. The Vendor shall develop and implement procedures to identify, prevent and ensure non-recurrence of defective services. The Vendor shall agree to participate in an on-going Quality Assurance surveillance plan. The Vendor shall be evaluated by the Government under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primary focused on what the Government must do to ensure that the Vendor had performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s). Vendor shall provide specimen transportation kit boxes and all applicable forms necessary to perform the specific testing. AVHCS shall provide the information as requested on the Oncotype DX Assay Requisition Form. The Vendor shall send the patients results to the lab department listed on the Requisition Form via fax (1-806-354-7865). The Vendor provides reports that summarize the findings of the patient s test. A detailed Oncotype DX GPS assay report is generated for each patient, with assay results provided as a Recurrence Score result (0-100). ACCREDITATION: The Vendor shall provide all licenses, permits, be able to meet accreditation and certificates required by law. The laboratory must be accredited by the College of American Pathologist (CAP) or be able to meet the Joint Commission and Clinical Laboratory Improvement Amendments (CLIA) (Public law 100-578) certifications. The Contractor will provide current copies of these records at the time of contract award and annually on the anniversary date of contract award to the COTR or, upon request. This notice is not to be considered a request for quotations or proposals. A contract will not be awarded based on an offer received in response to this notice; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Proposals or offers received will be used to determine if a comparable source is available and more advantageous to the government. If no affirmative written response is received within 7 days from the publication of this notice, a contract will be issued to MDxHealth. The anticipated statutory authority permitting other than full and open competition for the requirement is 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Notice: the POC for this notice does not have a Federal Business Opportunities registration account. Do NOT respond in the Interested Vendors List . The POC does not have any visibility to the Interested Vendors List tab within the notice. Interested firms must respond directly to the POC email address listed in the notice for consideration.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/348b67aba5d54ae88051d97d7bbb9275/view)
- Record
- SN06971686-F 20240223/240221230044 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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