AN12--Hereditary Cancer Test Kits - Base 9/23/20 - 9/22/21

PLEASE READ THIS ENTIRE NOTICE CAREFULLY AS IT CONSTITUTES THE ONLY NOTICE THAT WILL BE ISSUED. This is a synopsis for commercial service prepared in accordance with the format in FAR Subpart 12.6 and as supplemented with additional information included in this notice. The North American Industry Classification Systems (NAICS) code is 621511, and size standard is $35.0M. PAPER COPIES OF THIS SOLICITATION WILL NOT BE AVAILABLE AND TELEPHONE REQUESTS FOR COPIES WILL NOT BE HONORED. GENERAL: The solicitation will be issued as a commercial RFQ in accordance with FAR Parts 12 and 13, as a total small business set-aside. The resultant award will be a single fixed price commercial services contract. The period of performance is one year from date of award with one, one-year option period. Offerors wishing to submit an offer are responsible for downloading their own copy of the RFQ and for frequently monitoring the site for any amendments. Potential offeror s must be registered in the in the System for Award Management (SAM) https://www.sam.gov, have an active account and have completed the Representations and Certification sections prior to receiving a contract award (including the applicable NAICS listed above). Initial registration may take a couple weeks. Registration and instructions are available at www.sam.gov - registration is free. To be considered for award, vendors must submit their quotes on the solicitation document posted to Contracting Opportunities website, to include pricing and completion of all certifications and representations contained in the document. Offerors not submitting a fully completed quote will be considered non-responsive and will not be considered for award. DESCRIPTION/SPECIFICATIONS/WORK STATEMENT The VA Puget Sound Healthcare System Research & Development needs to obtain germline screening of veterans with metastatic prostate cancer. The following are draft requirements and will be updated in the solicitation. Background. This project is to establish infrastructure for more efficient germline screening of veterans. The project anticipates about 500 veterans will be eligible and participate in germline testing. Inherited DNA repair deficiency leading to the lethal form of prostate cancer has been recently recognized as a more frequent event than anticipated in metastatic prostate cancer (Pritchard, New England Journal of Medicine). The project proposes to test a new model of remote counseling and screening of veterans through a centralized program in order to increase the number of veterans with access to germline screening and the provide access to important treatment options which are not available without genetic testing. Identification of veterans who carry germline alterations which predispose to developing cancer is important as it also provides veterans families with critical health information for their own care. If the system is been shown to be efficient, this model could be easily implemented across all VA s providing easy test ordering, centralized test distribution and post-test counseling. The system would also enable easier access for veterans who are remote from VAMC for testing which could provide them with better care. Scope. The germline screening effort will be performed through the VA Puget Sound HCS for 500 veterans. VA Puget Sound HCS will receive referrals from participating VA medical centers. It is necessary for a referral to be placed to confirm a patient is appropriate for testing. VA Puget Sound HCS will review the patient s medical record and confirm the patients carry a diagnosis of metastatic prostate cancer and would be appropriate for therapy. Access to germline sequencing is not universally available for men with metastatic prostate cancer in VA and the point of this project is to streamline the process and make available counseling for those men who need it. VA Puget Sound HCS cannot order tests on patients who have not had a conversation with a provider and treating providers must identify relevant patients. The process of interfacility consult to VA Puget Sound HCS gives Seattle access to the patient s medical record to confirm they are appropriate for germline testing and documents the patient has had a discussion about germline testing with their treating provider. The interfacility consult also provides the contact information for the treating provider to receive the testing results directly from the contractor. Specific Tasks. Task: Perform germline sequencing of men with a diagnosis of metastatic prostate cancer through the coordinating center VA Puget Sound HCS. Contractor will provide pre-labeled trackable test kits for acquisition of samples to VA Puget Sound HCS or will mail the kits directly to the veterans home. Kits are then returned directly to the contractor for processing. The contractor will sequence DNA acquired through saliva samples from men with metastatic prostate cancer at their facility. The contractor will return results to the VA Puget Sound team and treating oncology provider at relevant site. Deliverables: Pre-labeled trackable DNA testing kits, DNA sequencing results. DNA collection kits must arrive at the VA Puget Sound HCS in Seattle or the Veteran s home within 5 business days from order date. When kits are sent back to vendor for DNA testing, the DNA sequencing results must be back within two months, which includes duration of shipping. 5. Performance Monitoring The contractor s timely performance of requested sequencing will be monitored by project lead. In the event that results are not delivered in a timely manner (within two months of sample submission) the contract will be reviewed and if not in compliance then possible termination procedures may result. 6. Special Considerations. The contractor must be CAP and CLIA certified lab that provides genetic testing for 30 different cancer related genes (APC, ATM, BAP1, BARD1, BMPR1A, BRCA1,BRCA2, BRIP1, CDH1, CDK4,CDKN2A (p14ARF and p16INK4a), CHEK2, EPCAM, GREM1, MITF, MLH1, MSH2,MSH6, MUTYH,NBN, PALB2, PMS2, POLD1, POLE, PTEN,RAD51C, RAD51D, SMAD4, STK11, and TP53). The kit must contain instructions and vial with preservative for a saliva sample which can be shipped either to the VA Puget Sound HCS in Seattle or to the veteran s home. Kits are returned to the contractor via the provided pre-labeled trackable box. DNA collection kit shall include genetic counseling provided by the vendor at no additional charge. The vendor will be required to enter into a Business Associate Agreement with the Department of Veterans Affairs. RFQ PACKAGE: It is anticipated solicitation package 36C26020Q0790 will be available for download from the Contracting Opportunities beta.sam.gov on or around August 28th, 2020. Offerors are advised that they are responsible for obtaining amendments to the solicitation which will be available at the Contracting Opportunities website. No telephone or fax requests for the solicitation package will be accepted and no solicitation packages will be mailed. A bidders list will not be maintained by this office. Responses must be concise and be specifically directed to the requirement reference above. Failure to respond to the electronically posted RFQ and associated amendments prior to the date and time set for receipt of quotes may render vendor offer non-responsive and result in rejection of the same. LATE SUBMISSIONS WILL NOT BE ACCEPTED. All inquiries must be via email, and all questions and responses will be posted to the Contracting Opportunities website as an amendment to this original announcement. Questions concerning this solicitation MUST be submitted via email to Karen.rhodes@va.gov.