Q301 Histocompatibility Transplant Testing and Interpretation

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

To provide histocompatibility and immunogenetics testing and interpretation services to support the VA Portland Health Care System (VAPORHCS) transplant program. This is required because VAPORHCS does not have the in-house capability or OPTN accreditation to perform these specialized tests.

• Provide patient specimen testing for a specific range of referral tests, including analytical testing, reporting, and interpretation.

• Perform pre-analytical processing, analysis, and reporting of results.

• Provide necessary supplies, including requisition forms, specimen containers, and collection kits. The contractor is responsible for shipping these supplies to patients and other VA facilities and providing return shipping capability.

• Maintain active membership and compliance with Organ Procurement and Transplantation Network (OPTN) requirements, including any updated bylaws.

• Demonstrate affiliation with the federally designated OPO of Oregon and with each Transplant Service supported, including the Portland VA Transplant Program.

• Provide robust on-call services for critical donor testing 24/7.

• Perform various non-testing tasks related to transplant patient management, including OPTN kidney waitlist registration, management of hard-to-transplant candidates, crossmatch protocols, antibody screening, and coordination with OPOs.

• Comply with all applicable federal, state, and local regulations, laws, and ordinances.

• Routine test results reported within specified turnaround times (TAT). STAT testing for deceased donors must begin within one hour of sample arrival or verbal request, with results reported within 6 hours.

• Maintain minimum acceptable service, reporting systems, and quality control.

• Notify VA Facilities of any testing delays within 12 hours.

• Notify VA Facilities of any specimen problems within 24 hours of shipping.

• Maintain a minimum of 95% success rate for proficiency testing.

• Performance Standards include 100% compliance with quality of work and security requirements, and 95% compliance with timely invoicing and testing completion.

• A multi-year award for a Blanket Purchase Agreement (BPA) with a five-year period of performance (one base year and four one-year options) from the date of award.

• Place of Performance to be determined upon award.

• Laboratory must be accredited by OPTN and meet ASHI or CAP standards.

• Must possess an active membership through OPTN and comply with its bylaws.

• Must demonstrate affiliation with the OPO of Oregon and the Portland VA Transplant Program.

• All personnel must meet CLIA '88 qualifications and possess current professional certifications.

• Employees are subject to low-risk background investigations.

• Adherence to strict security requirements, including data protection, encryption, and incident reporting.

• Compliance with VA records management obligations.

• Provide 24/7 customer service and access to medical/technical directors for consultation.

• Electronic transmission of test results in compliance with HIPAA.

• Evaluation criteria: Technical performance (80%), Past performance (10%), Price (10%).

Form / Attachment / Pricing Sheet

This document is a pricing sheet, specifically detailing "Bridge Pricing" for Histocompatibility testing services. It outlines various tests, their associated CPT codes, estimated annual utilization, and pricing across five ordering periods.

• Test Name: Lists specific histocompatibility tests (e.g., HLA-A LOW RES, HLA-DR LOW RES, T-CELL CROSSMATCH).
• CPT Code: Provides the Current Procedural Terminology code for each test.
• Annual Estimated Utilization: Indicates the estimated number of times each test is expected to be performed annually.
• Price Ordering Periods: Details the pricing for each test across five distinct one-year ordering periods, from April 1, 2026, to March 31, 2031.
• Test Performed in House: A column indicating if the test is performed internally.

This pricing sheet is crucial for bidders to understand the cost structure for the required histocompatibility testing services. Vendors should use this information to formulate their pricing proposals, ensuring their bids are competitive and accurately reflect the anticipated costs over the contract's potential duration. The utilization estimates provide a basis for forecasting potential revenue and resource allocation.

Form / Attachment / Pricing Sheet

This document outlines the Technical Evaluation Factors for Histocompatibility and Immunogenetics testing & interpretation Reference Laboratory Services. It details specific requirements related to testing, professional fees, licensures, certifications, accreditations, and operational capabilities.

• Testing and Fees: Vendors must be able to provide comparable tests outlined in Attachment B (SOW E.5). Any reflex testing, panel test components, or professional fee/interpretation components must be itemized and added to the original test list prior to award (SOW E.4).
• Licensures/Certifications (SOW I.1-5): Requires a License for Laboratory Director, CLIA certificate (including specialties/subspecialties), state license (if required), and proof of accreditation through CAP or equivalent agency.
• Personnel: Identification of individuals for General Supervisor, Clinical Consultant, and Technical Supervisor roles (SOW M.4).
• Turn Around Time (TAT) (SOW G.2. & G.3.): Specific TATs for STAT deceased donor HLA typing (1 hour) and STAT deceased donor crossmatch (6 hours).
• Accreditation/Membership: Requirement for accreditation/membership through OPTN (SOW E.6).
• OPO Relationship: An existing relationship with Cascade Life Alliance (Oregon's federally designated OPO) and proof of a written agreement (SOW E.8).
• Transplant Service Affiliation: An affiliation agreement with each supported Transplant Service, specifically the Portland VA Transplant Service, or agreement to enter into one (SOW E.9).
• Non-Testing Tasks: Agreement to perform numerous non-testing tasks for the Portland VA related to transplant patients (SOW E.10.a-r).
• On-Call System: A robust 24/7 on-call system for critical donor testing services (SOW E.9).
• Courier Services: Provision of courier services or a specimen transport method (SOW K.1-6).

This attachment is critical for bidders to understand the specific technical and operational requirements for providing Histocompatibility and Immunogenetics testing and interpretation services. It details essential qualifications, performance standards, and documentation needed to be considered for this opportunity. Bidders must ensure their proposed services and capabilities align with all listed factors, including specific TATs, accreditations, and relationships with healthcare organizations.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial services, specifically Reference Laboratory Testing for the VA Portland Health Care System. The government intends to award a firm-fixed-price Indefinite Delivery Indefinite Quantity (IDIQ) contract.

• Reference Laboratory Testing services as detailed in the Statement of Work (Attachment A).

• Offerors must complete Attachment B (Test List Histocompatibility) and B.2 (Price/Cost Schedule).

• Offerors must address Technical Evaluation Factors outlined in Attachment C.

• Contract Type: Firm-Fixed Price IDIQ

• Period of Performance: Five Ordering Periods, from 04/01/2026 to 03/31/2031.

• Minimum Guarantee: $1,000.00

• Total Capacity: $9,000,000.00 over the entire Period of Performance.

• Response Date/Time: 02-27-2026 17:00 Pacific Time, Los Angeles, USA.

• Technical Evaluation Factors are detailed in Attachment C.

• Price is also a key evaluation factor.

• This acquisition is NOT set aside for small business concerns; it is an unrestricted acquisition.

• Solicitation Number: 36C26026Q0245

• NAICS Code: 621511 (Size Standard: $41.5 Million)

• Product/Service Code: Q301

• Point of Contact for questions: Eric Lingenfelter, eric.lingenfelter@va.gov, 360-852-9891.

• Attachments referenced: Attachment A (Statement of Work), Attachment B (Test List Histocompatibility), Attachment C (Evaluation Factors).