Q301--Transplant Rejection Detection Molecular Genetic Testing

Statement of Work (SOW) / Performance Work Statement (PWS)

To provide molecular genetic testing services for transplant rejection detection to monitor transplant patients and enable timely detection of organ rejection to improve patient outcomes.

• Provide diagnostic laboratory services for molecular expression genetic blood testing.

• Detect organ rejection, guide treatment, and support patient care.

• Perform laboratory testing, analysis, and result interpretation.

• Provide specialized molecular analytical testing with varying support levels.

• Perform testing entirely on contractor premises.

• Provide individual patient-chartable test result reports meeting CLIA requirements.

• Provide all appropriate requisition forms and unique supplies for sample collection at no additional charge.

• Maintain confidentiality of patient records, only releasing with written patient consent.

• Services include molecular testing, specimen preparation and storage, analytical testing, reporting of results, and consultative services.

• Specific tests include Molecular expression transplant assessment testing, Molecular Assessment for Kidney Disease, and Molecular Genetic Prenatal Screening Test.

• Tests to be performed and reported within established vendor turnaround times.

• Maximum turn-around-time (TAT) shall not exceed three weeks from specimen submission.

• Provide encrypted and/or secured electronic transmission of all completed and/or partial test results within published TAT.

• Test reports must include specific patient and test information, including patient name/ID, physician name, specimen receipt/collection/completion dates, test results, reference ranges, and laboratory details.

• Contract term is estimated to begin January 2027 and last for five years.

• Services are to be performed on the contractor's premises.

• Licensing and Accreditation: Laboratories must be fully licensed and accredited (e.g., by CAP, state regulatory agencies) and CLIA certified.

• Compliance: Must comply with all local, state, and federal laws, CLIA, HIPAA, OSHA, and CDC regulations.

• Quality Assurance: Maintain quality assurance programs meeting federal regulations and CAP certification.

• Personnel: Contractor personnel must meet CLIA qualifications and be proficient in English. Maintain current accreditation and notify the Contracting Officer of any lapse.

• Reporting: Provide encrypted/secured electronic transmission of results. Reports must contain specific data elements.

• Specimen Retention: Retain specimens as required by regulatory agencies, or for 7 days for clinical specimens if no regulatory requirement exists.

• Pricing: Contractor's standard price list must reflect GSA pricing, including CPT code, product name/description, price, test description, and reference ranges.

Sources Sought Notice / Request for Information (RFI)

This notice is for market research and planning purposes only, issued by the Department of Veterans Affairs (VA), Network Contracting Office 19 (NCO 19) for the Salt Lake City VA Medical Center. The VA is seeking potential sources for Transplant Rejection Detection Molecular Genetic Testing.

Interested contractors must submit:

• An overview of proposed solutions.

• A description of products offered, in accordance with the draft Statement of Work (SOW) / Salient Characteristics List.

• Responses to a market research table questionnaire.

• Molecular Expression Transplant Assessment Testing

• Molecular Assessment for Kidney Disease

• Molecular Genetic Prenatal Screening Test

• Response Date/Time: June 30, 2026, 15:00 Mountain Time, Denver, USA.

• Submission Method: Email to Lindsey.Zwaagstra@va.gov.

• Page Limit: Maximum of 8 pages, including cover letter.

• Confidentiality: Mark responses as "Proprietary Information" if business sensitive.

• Primary NAICS Code: 621511 – Medical Laboratories.

• Small Business Size Standard: $41.5 Million.

• Bidders are requested to identify and explain any alternative NAICS codes they believe better represent the work.

Respondents must provide:

• Company Name, Address, UEI Number, Contact Information (Name, Phone, Email).

• Business Size Information (Small Business categories, Large Business).

• FSS/GSA Contract details (if applicable).

• Proposed solution availability on FSS/GSA Contract.

• Pricing structure (All on FSS, Open Market, Mix, Cost Per Test, Firm-Fixed Price, Other).

• Responses to Federal Acquisition Regulation (FAR) Market Research Questions (Buy American Act).

• Specific questions for Small Businesses regarding Limitations on Subcontracting and Nonmanufacturer Rule.

• This is NOT a solicitation or request for proposal.

• No award will be made based on responses to this notice.

• The Government will not pay for any information received or costs incurred in developing the response.

• Attachment 1 - SOW (Statement of Work)