THIS IS A SOURCE SOUGHT NOTICE / RQUEST FOR INFORMATION (RFI) ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND/OR QUOTE. The Department of Veterans Affairs (VA), Veterans Integrated Systems Network (VISN) 19 and the Network Contracting Office (NCO) 19 are performing market research to determine if there are sufficient numbers of qualified (1) Service Disabled Veteran Owned Small Business; (2) Veteran Owned Small Business; or (3) Small Business to set aside a Firm Fixed Price requirement for Germline Genetic testing services for the Salt Lake City VA Medical Center. The Government will use responses to this notice to help make the appropriate acquisition strategy decision. Contractor shall furnish all labor, materials, equipment, and facilities to provide a complete range of genetic testing for adult conditions to include, but not limited to: cancer, cardiovascular, neurological and neuromuscular conditions, mitochondrial conditions, metabolic conditions, ophthalmology, endocrine disorders, renal disorders, immunologic disorders, rheumatologic disorders, skeletal disorders, and preconception/prenatal screening. Services are to be performed in accordance with the standards of the College of American Pathologists (CAP) and Clinical Laboratory Improvement Acts (CLIA). The contractor shall be responsible for performing analysis and result interpretation for patient specimens, as requested by the VA Salt Lake City Health Care System 500 Foothill Drive, Salt Lake City, Utah 84148. Services shall include the transportation of specimens to the contractor s laboratory(ies), the performance of genetic testing, the reporting of test results, and consultative services, as required to assimilate the full scope of its laboratory operations, to the ordering facility. The contractor shall provide varying levels of support services depending on the unique characteristics presented by each individual ordering activity. All interested firms shall submit a response demonstrating their capabilities regarding the above requirement and addressing each of the items in the following section. As stipulated in FAR 15.201, responses to this notice are not considered offers and cannot be accepted by the Government to form a binding contract. No solicitation exists; therefore, do not request a copy of the solicitation. The decision to solicit for a contract shall be solely with the Government discretion. RESPONSE REQUIREMENTS Please address and/or provide proof of each of the following as requested below: FSS/GSA Schedule: Do you have a current FSS/GSA Schedule for Germline Genetic Testing and if so please provide the contract number? Past Performance/General: Give examples of similar size and scope contracts in last five years Volume: What volume can you provide on monthly basis? Is testing done on-site or at wholly owned subsidiaries? Is interpretation done by lab employees or by employees at wholly owned subsidiaries? Evidence of ability to provide genetic testing for adult conditions to include, but not limited to: cancer, cardiovascular, neurological and neuromuscular conditions, mitochondrial conditions, metabolic conditions, ophthalmology, endocrine disorders, renal disorders, immunologic disorders, rheumatologic disorders, skeletal disorders, and preconception/prenatal screening. Certifications: Please submit evidence of the following: CAP-certified CLIA-accredited Process/Ordering: Do you offer each of the following (Yes/No): Provider created custom gene panels (ability to add and subtract genes from already curated panels) at no additional cost Ability to reflex to a larger panel of genes associated with phenotype at no additional cost. Site-specific mutation testing, utilizing a previous family member s test result Define variant reclassification program including family studies Online ordering portal with ability to: auto populate provider/billing info search by gene/panel name ability to customize panel via portal alert provider to test result Mailing account number to cover costs of shipping in the US Provide specimen collection supplies for specialized testing. System/process for provider inquiry to status of pending tests Accept orders without requiring additional signed consent forms beyond a provider s attestation on the test requisition form. Please provide a Laboratory User s Manual or similar documentation. The manual shall include a list of all tests that the Contractor can provide along with the testing methodology used for each test, turn-around time for each test, days the test is run, and specimen requirements and any special handling required. Consultation Services: Consultation may be required with VA Laboratory and providers regarding test results and interpretation by telephone. What is your process to provide direct access to a genetic counselor and/or medical geneticist who signed out the test? Describe your account servicing plan, to include information on representative, genetic counselors, contact information, means of contact, turnaround time on inquiries. Methodology Is your organization able to provide RNA sequencing? If yes, for what tests/indications? Is RNA testing done internally or through sub-contractor(s)? Data Does your organization have the ability to send raw data files (e.g., BAM, BAI and VCF files)? Does your organization have the ability to interface with the VA laboratory information system to facilitate test ordering and reporting? Price/Billing Provide a list of tests currently available with a price list. Reporting Provide an example of a standard test result report, including field values, for the following tests: BRCA2 pathogenic BRCA2 VUS Breast cancer panel negative TP53 low mutant allele fraction APC p.I1307K RAD50 pathogenic TTN likely pathogenic Key Personnel: Please provide qualifications of Medical Director to include education, certifications, professional experience (dates of service) Firms responding should indicate whether they are, or are not, a service-disabled veteran owned small business, a veteran owned small business, or any other type of small business business. The NAICS code to be used for this acquisition is 621511 (Medical Laboratories) is applicable to this acquisition, and the size standard is $35.0 million. The Government reserves the right to consider all types of small business set-asides based upon responses hereto for any subsequent acquisition. Respondents are further requested to indicate their status as a foreign-owned/foreign-controlled firm and any contemplated use of foreign national employees on this effort. Any information submitted by respondents to this sources-sought synopsis is voluntary. This sources-sought notice is not to be construed as a commitment by the Government, nor will the Government reimburse any costs associated with the submission of information in response to this notice. Respondents will not individually be notified of the results of any Government assessments. The Government s evaluation of the capability statements received will factor into whether any forthcoming solicitation will be conducted as a full and open competition or as a set-aside for small businesses, or any small business designation (e.g. SDVOSB, HUB Zone, 8(a), WOSB, VOSB, etc). All prospective vendors must be registered and current within the System for Award Management (SAM). Visit www.sam.gov for details. In addition, all SDVOSBs and VOSBs must be registered and verified within VetBiz. Visit www.vetbiz.gov for details. All responses must be received by 03-23-2021 at 3:30 pm MT POC for this notice is Ian Boettcher / [email protected]

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