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Sources Sought Notice Sources Sought Notice Page 3 of 4 Sources Sought Notice *= Required Field Sources Sought Notice Page 1 of 4 DESCRIPTION Page 4 of 4 Page 1 of REQUEST FOR INFORMATION / SOURCES SO... Sources Sought Notice Sources Sought Notice Page 3 of 4 Sources Sought Notice *= Required Field Sources Sought Notice Page 1 of 4 DESCRIPTION Page 4 of 4 Page 1 of REQUEST FOR INFORMATION / SOURCES SOUGHT INQUIRY THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL. The Department of Veterans Affairs Network Contracting Office (NCO) 19, Rocky Mountain Acquisition Center (RMAC) is seeking information and sources that can provide Prostate Testing and Reporting for Salt Lake City Regional VA Medical Center, located at 500 Foothill Blvd, Salt Lake City, UT 84148. The NAICS code is 621511 Medical Laboratories and Small Business Size Standard is $41.5 Million. The Contractor shall provide Prostate Testing and Reporting. The prostate test and report will be used to determine how likely the patient s cancer is to metastasize within the next five years. The test is performed on tissue samples obtained during biopsy or surgical removal of the prostate. This is a request for information and sources only, which may or may not lead to a future solicitation! This is not a request for proposal (RFP). No questions will be answered. The VA will not pay for any information received resulting from this, sources sought notice. Information should be forwarded to the Contracting Officer and Contract Specialist. If your organization can provide these services and is interested in this opportunity, please respond to Devin Reichert, Contract Specialist via e-mail at devin.reichert@va.gov and NCO19LAB@va.gov with the above information requested. The response due date for this information is 9 AM Mountain Time, on Friday, November 28th, 2025. In response to this announcement, please provide the information below: Company Name: Address: UEI (Unique Entity ID) Number: Contact Name: Phone No.: Email: Business Size Information - Select all that applies: Small Business Emerging Small Business Small Disadvantaged Business Certified under Section 8(a) of the Small Business Act HUBZone Woman Owned Certified Service-Disabled Veteran Owned Small Veteran Owned Small Business Large Business FSS/GSA Contract Holder: Yes No FSS/GSA Contract Number: Effective Date/ Expiration Date: Proposed solution is listed and available on the above FSS/GSA Contract: Yes No Available pricing structure of proposed solution (select all that are applicable below): Pricing Model Please Indicate Availability Below: (Yes / No / NA) All on FSS Open Market only Mix of FSS & Open Market (CPRR) Cost Per Reportable Result Cost Per Test(CPT) Reagent Rental Agreement Equipment Rental with Reagent Purchase Fixed Monthly Charge Other: (Please explain) Federal Acquisition Regulation (FAR) Market Rearch Questions: Buy American Act (FAR 52.225) What percentage of the proposed product (including leases) is a: Domestic end product? _____________ (%) Foreign end product? _______________ (%) Questions for Small Businesses ONLY: Limitations on Subcontracting (FAR 52.219-14) What percentage of the work would be subcontracted to another company? ________ If > 0, what is company s business size: __________ If subcontracting, what added value do you offer (FAR 52.215-23): _______________________________ DEPARTMENT OF VETERANS AFFAIRS VA MEDICAL CENTER, SALT LAKE CITY, UT STATEMENT OF WORK PROSTATE TESTING AND REPORTING Introduction Department of Veterans Affairs, Veterans Health Administration, Salt Lake City VA Medical Center (VAMCSLC), 500 Foothill Drive, Salt Lake City, Utah 84148 has a requirement for reporting from prostate testing. The contract will be awarded as a firm fixed price contract as a blanket purchase agreement with a 5-year ordering period. Scope of Work The Contractor will provide Prostate Testing and Reporting. The prostate test and report are used to determine how likely the patient s cancer is to metastasize within the next five years. The test is performed on tissue samples obtained during biopsy or surgical removal of the prostate. Description The contractor shall be responsible for performing laboratory testing, analysis, and result interpretation on behalf of the VAMSLC facility in accordance with the terms, conditions, and provisions outlined thereof. The testing report will provide personalized treatment where the tumor analysis will identify patients at high versus low risk of progression of cancer. The services performance shall include genomic testing with varying levels of support services depending on the unique characteristics presented by each individual ordering activity. The contractor shall perform testing entirely upon their premises. Tests will be performed and reported within established vendor turnaround times. The contractor shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations as they pertain to a licensed clinical laboratory. The contractor shall provide individual patient-chartable test result reports meeting Clinical Laboratory Improvement Amendments (CLIA) requirements. The contractor shall provide all appropriate requisition forms and unique supplies needed for specialized collection of samples, at no additional charge. Notwithstanding, anything to the contrary in this Agreement or otherwise,The contractor shall not release patient records that include test results, without the specific written consent to release such information as provided by the patient, to any person other than the ordering healthcare provider or designee. All patient records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient's records. This provision shall survive termination of this Agreement. The required highly specific molecular testing reference laboratory services include but are not limited to the identified required test menu testing, specimen preparation and storage of clinical laboratory specimens, performance of analytical testing; reporting of analytical test results; and consultative services. SALIENT CHARACTERISTICS (TECHNICAL SPECIFICATIONS) Dynamic Report A report must be generated with the Patient Information, Specimen Information, Ordering Physician, Clinical and Pathology Details, Genomic Score, Genomic Score Interpretation, Risk Graph, Risk Estimates, Risk Graph Interpretation, Clinical Findings, Test Description, Intended Use, Confidence Interval, and References. Genomic Score A Genomic Score must be generated based off of the genomic risk of metastasis, tumor biology alone, independent of clinical & pathological factors (e.g., Gleason, PSA), the 22 genes, 7 biological pathways, and continuous genomic risk score classified as low, intermediate or high. Genomic Score Interpretation Provide a summary based on this patient s genomic risk & relevant clinical findings. Risk Estimates Provide the risk estimates of the patient with standard therapy. Risk Graph Provide a Graph to show the patient their risk compared to patients with similar clinical and pathological features. Risk Comparison Provide a comparison of the patient and their risk compared to patients with similar clinical and pathological features. Risk Graph Interpretation Explains risk comparison graphic. Provides this patient s percentile rank in the tested population. Clinical Findings Provide clinical study results relevant to this patient. Test Description Provide a summary of testing platform technology. Risk estimates. Provide cut points separating low, intermediate & high risk. Intended Use Provide a summary of the intended use in biopsy specimens from patients. Confidence Interval Confidence Intervals Provide a confidence interval for each risk estimate. References Provide references for each of the clinical studies cited in the report. These tests will need to be provided to ensure efficient evaluation and management of prostate cancer. - Prolaris (Myriad Genetics) Purpose: Predicts cancer aggression and ideal treatment path. - Promark (Metamark Genetics) Purpose: Predicts cancer aggression and recurrence. - Benign Prostate Tissue Evaluation: Purpose: Evaluates tissue deemed benign (no malignancy found) to assess the risk of future malignancy. - Oncotype DX (Genomic Health) Purpose: Utilized for breast or colon cancer assessment. Schedule of Services Every test must include Patient Information Specimen Information Ordering Physician, Clinical and Pathology Details Genomic Score Genomic Score Interpretation Risk Graph, Risk Estimates Risk Graph Interpretation Clinical Findings Test Description Intended Use Confidence Interval References. General Requirements The contractor s standard price list of all testing services available along with the price to be billed to the VHA for each testing service shall reflect that which is listed in their GSA price list. The price list, at a minimum, shall include the following data elements: CPT code Product Name/Description Price Test description, including reference ranges and units of measurement Maximum turn-around-time (TAT) shall not exceed three weeks from specimen submission.  Test Result Reporting The Contractor shall provide encrypted and/or secured electronic transmission (i.e., fax and/or on-line web access) of all completed and/or partial test results to the ordering activity within published turnaround time of fifteen days. All payments shall be made in arrears (30 days) upon receipt of a proper invoice. Invoices must contain at a minimum the following information. The contractor shall provide this information on one original invoice: i. Invoice Number ii. Date of Service iii. Test Description and CPT Code iv. Unit cost v. Total cost Mandatory Requirements Licensing and Accreditation: Only fully licensed and accredited laboratories actively engaged in providing the specific services and laboratory testing outlined. The contractor shall have all the licenses, permits, accreditation and certificates required by law. The reference laboratory must be licensed and accredited by the College of American Pathologists (CAP) and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Amendments of 1988. The contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America prior to contract award. In addition, the contractor shall be responsible for providing a written guarantee or evidence that all subcontractors have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award. Any proposed subcontractor changes during the contract performance period must have prior approval by the Local VA Point of Contact (POC). The Contractor policies and procedures shall comply with the Health Insurance Portability and Accountability Act (HIPAA). The contractor will provide and maintain quality assurance programs which meet federal regulations for laboratory operations. The contractor will be certified by the College of American Pathologist under the CLIA. The contractor shall notify the POC in writing of any malpractice investigation or licensure or certification suspension which concerns the contractor or any employees, within 24 hours of notification of an investigation or suspension. Contractor Personnel: The contractor shall maintain current accreditation and notify the POC of any lapse in state license, CLIA certification, or clinical pathology certification. The contractor shall provide a copy of renewed licenses/certificates to the POC before expiration. Contractors Responsibilities Procedure Guidance: The testing methodology and reference ranges for a test must be defined and available electronically. The contractor shall provide change notice prior to implementation of any new medical procedures and services. The contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy. Upon request by the Laboratory Point of Contact (POC), the contractor will make available quality assurance information on specific testing procedures for review. In the event of tests being referred to another laboratory, there shall be no additional transfer charge or confirmation charge to the government. Reporting of Results: A testing report is defined as a printed final copy of laboratory testing results. The report(s) shall be available on an encrypted and/or secured electronically with on-line web access and /or secured facsimile (Fax). Each test report shall at minimum indicate the following information: i. Patients name and/or identification code (social security number) PII Safety Protocols must be Enacted. ii. Physician s name (if supplied) iii. Date/time specimen received in reference lab iv. Test ordered v. Date/time of specimen collection (when available) vi. Date test completed vii. Test result viii. Flag abnormal ix. Reference range x. Toxic and/or therapeutic range where applicable xi. Testing laboratory specimen number xii. Name of testing laboratory and address (contractor and/or subcontractor) xiii. Type of specimen xiv. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing Retention of Specimens: Upon completion of the testing procedures, the contractor shall retain all specimens as required by regulatory agencies. Upon request by the ordering activity POC or designee, the contractor shall provide a copy of the regulatory requirements for each participating regulatory agency. In the absence of regulatory agency requirements, the contractor shall retain specimens, after all testing has been completed for clinical specimens (7) days. Special Contract Requirements Services: The services specified herein may be changed by written modification to the BPA. The VA POC will prepare the modification and, prior to becoming effective, must be signed by both parties. Only the POC is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this agreement. In the event the contractor affects any such change at the direction of any person other than the POC, the change shall be considered unauthorized, and no adjustment will be made to the contract price to cover any increase in costs incurred as a result thereof. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor s employee(s). Contractor personnel are not subject to the supervision and control of a government officer or employee. Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare provider who furnishes services under this contract is subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered. Contractor is required to maintain medical liability insurance for the duration of this contract. Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance. Contractor shall, in writing, keep the POC informed of any unusual circumstances in conjunction with the contract. Contractor shall not, under any circumstances, furnish reports directly to patients. Term of the Contract The contract will be awarded as a firm fixed price contract as a blanket purchase agreement with a 5-year ordering period. Federal Holidays The contractor is not required to provide these laboratory services on federal holidays. The 10 holidays observed by the Federal Government are: New Year s Day (January 1st) Martin Luther King s Birthday (3rd Monday in January) Presidents Day (3rd Monday in February) Memorial Day (last Monday in May) Independence Day (July 4th) Labor Day (1st Monday in September) Columbus Day (2nd Monday in October) Veterans Day (November 11) Thanksgiving Day (4th Thursday in November) Christmas Day (December 25th) Any other day specifically declared by the President of the United States to be a national holiday. When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies. Qualifications/Requirements of Laboratory & Contractor Personnel Laboratory: The contractor to including subcontractor(s), must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the CLIA of 1988, or must demonstrate accreditation by a regulatory agency(s) with deemed status from the College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory must maintain valid certifications during the entire performance period of this contract. Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this procurement action. In addition, as these documents are re-issued or re-awarded, the awarded contractor must supply a copy to the POC assigned to the servicing Government facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary contractor. The contractor must notify immediately the POC in writing, upon its loss of any required certification, accreditation, or licensure. The contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention. End of Statement of Work