Q301--Tissue Typing and Immunogenetics Lab Services

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

To provide high-quality, reliable, and timely immunogenetics laboratory services to support the James J. Peters VA Medical Center (JJP VAMC) renal transplant center's mission of providing empathetic, lifesaving care to kidney transplant recipients.

• Provide comprehensive tissue typing and immunogenetics laboratory services.

• Perform HLA typing and compatibility services for deceased and living donor solid organ transplants.

• Conduct antibody screening and identification for recipients, including donor-specific antibodies (DSA).

• Perform crossmatching (physical and/or virtual) for donor-recipient pairs.

• Conduct post-transplant monitoring for DSA and specific immunologic tests as requested.

• Handle all patient and donor specimens safely and securely, including receipt, labeling, transport, and storage.

• Deliver test results and communicate critical findings accurately and in a timely manner.

• Prioritize veteran patients, even during high-volume periods.

• Provide 24/7, 365-day coverage, including after-hours and emergency testing.

• HLA Typing: High-resolution typing for HLA loci A, B, C, DRB1, DRB3/4/5, DQA1, and DQB1. Minimum of two separate typing tests for deceased donors. Accuracy of 99.9% on all reported HLA typing results.

• Antibody Screening: Turnaround time for STAT DSA less than 4 hours. All HLA antibody reports reviewed and approved by a qualified supervisor.

• Crossmatching: STAT virtual crossmatches less than 2 hours; STAT crossmatches with antibody screening less than 4 hours. All crossmatch results reported verbally for STAT cases, followed by a written report.

• Post-transplant monitoring: Deliver results within agreed-upon turnaround times.

• Specimen Handling: Zero incidents of specimen mix-up or misidentification.

• Reporting: Deliver results and critical findings within 4 hours. Verbal reporting for STAT tests followed by written report. 100% of STAT results verbally reported within the specified timeframe.

• Period of Performance: Five years from the date of award.

• Place of Performance: All work performed at the Contractor's facility.

• Contractor must be fully compliant with all relevant security and privacy regulations, including HIPAA.

• Contractor must be a laboratory fully accredited by ASHI and CLIA-certified.

• Laboratory director must be a diplomate of the American Board of Histocompatibility and Immunogenetics (ABHI) or equivalent.

• All personnel performing testing must be appropriately qualified and trained.

• Provide proof of Clinical Laboratory Improvement Amendments (CLIA) Certification, ASHI Accreditation, CAP Accreditation, FDA Certification, ABMGG, Continuing Education, and State Laboratory License.

• Maintain an effective Quality Control Plan (QCP).

• Participate in External Proficiency Testing (EPT) programs.

• Provide a comprehensive contingency plan for service interruptions.

• Deliverables include: Monthly status reports, completed test reports, Quality Control Plan, and proof of EPT participation.

• Government will conduct surveillance under a Quality Assurance Surveillance Plan (QASP).

• Government will not furnish any property or equipment.

Form / Attachment / Pricing Sheet

This document provides an estimated quantity per testing service. It details the specific types of HLA and other related testing services along with the corresponding quantity or units required for each.

• Description of Goods or Service: Lists various testing services such as ABO Blood Group Typing, different types of HLA typing (e.g., High Resolution, Low Resolution, STAT), CDC PRA, Luminex Panel PRA, Luminex Single Antigen Bead assays, Crossmatch services, Donor Workup, Flow Cytometry services, Serum Processing, and specialized analyses like Donor HLA Specific Analysis and validation services.
• Quantity / Units: Specifies the estimated number of units for each listed service.

This document is crucial for bidders as it outlines the expected volume of work for each testing service. This information is essential for developing accurate pricing, estimating resource needs, and understanding the scope of potential contract performance. Bidders should use these quantities to inform their proposals and ensure they can meet the projected demand.

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

The James J. Peters VA Medical Center's Renal Transplant Program requires specialty tissue typing and immunogenetic laboratory services. These services are vital for matching organ donors with recipients, decreasing rejection rates, and increasing graft longevity. The testing is also critical for diagnosing and preventing transplant rejection.

This Performance Work Statement (PWS) outlines the requirements for a contractor to provide a full range of tissue typing and immunogenetics laboratory services within a four-hour turnaround time. These services are essential for supporting solid organ and/or hematopoietic stem cell transplantation programs, disease association studies, and transfusion support. The scope includes complex and specialized testing to determine donor-recipient compatibility and to monitor immunologic complications.

• Place of Performance: Department of Veterans Affairs, Bronx VA Medical Center, 130 W Kingsbridge Rd, Bronx NY 10468-3904.

• Services must be provided within four hours.

• The contractor will support transplantation programs, disease association studies, and transfusion support.

• This document references attached documents: P02 Sources Sought Notice, PWS, and Testing.

Sources Sought Notice

This notice is issued by VISN 2 Contracting Office in Albany, NY, for market research purposes to collect information regarding Tissue Typing and Immunogenetics Lab Services at the Bronx VA Medical Center. The government is seeking to establish this new service as of 12/01/2025. This notice is not an offer or solicitation, and responses will not be treated as proposals.

• The requirement is detailed in a Performance Work Statement (PWS).

• NAICS Code: 621511 (Medical Laboratories)

• PSC Code: Q301 (Medical – Reference Laboratory Testing)

• Interested parties must email a capability statement and full information to Mariangie Rivera at Mariangie.Rivera@va.gov.

• Deadline: November 13, 2025, by 10:00 AM Eastern Time.

• Responses are for determining procurement strategy and viability of sources, including potential set-asides for socio-economic categories (SDVOSB, VOSB, WOSB, HUBZone, 8(a), small business).

• Company name, Point of Contact, capability statement, examples of similar work, UEI and DUNS number, address, and social-economic category.

• If claiming SDVOSB, VOSB, or other special category, provide supporting documentation.

• Specific details regarding site location, self-performance plan, subcontracting plans, company and technician experience, past performance examples, Federal Supply Schedules, teaming agreements, and relevant certifications.

• The government is assessing the viability of setting aside the requirement for specific socio-economic categories.

• A VA Notice of Limitations on Subcontracting clause (852.219-77) is included, requiring certification of compliance with subcontracting limitations (50% for services, unless otherwise specified).

• The document includes a "Limitation on Subcontracting – Certificate of Compliance Clause" that must be completed, signed, and returned with any response. Failure to provide this certification may result in the offer being deemed ineligible for award.