6630--VISN 15 Automated Erythrocyte Sedimentation Rate Analyzers 36C255-26-AP-0538

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

To establish a Cost per Test agreement for Automated Erythrocyte Sedimentation Instrumentation for VISN 15 Pathology & Laboratory Services.

• Acquisition of new equipment for clinical laboratories within VISN 15, with potential for adding or deleting facilities.

• Provision of continuously stocked inventory of reagents, standards, controls, supplies, and disposables.

• The contract will be a single award, firm-fixed price with 5 ordering periods, starting 05/01/2026 through 04/30/2027 for the first year.

• Equipment must meet CLIA and CLSI performance standards for accuracy and precision.

• Contractor is responsible for providing all necessary materials and maintenance for equipment operation.

• Validation of new equipment must be completed 30 days before April 30, 2026.

• Equipment must meet specific operational/technical features including FDA approval, ESR capability, throughput to meet demands, QC data management, on-board reagent inventory management, primary tube sampling, continuous loading of specimens, and ability to test 0.5 ml samples.

• Hardware features include clear displays and a printer for patient reports.

• Bi-directional, bar-coded computer interface compatible with VA laboratory information systems (Oracle Health/Cerner) is required.

• Analyzer must have a bi-directional HL7 interface with Dual TCP/IP capability.

• Method performance/validation includes correlation studies, Analytical Measurement Range (AMR) validation, precision studies, sensitivity, specificity, and reference range determination.

• Equipment must maintain an uptime of 90% each month.

• Repair response time no more than 24 hours; 24/7 technical assistance with a 1-hour callback response.

• First year ordering period: 05/01/2026 through 04/30/2027.

• Facilities located within VISN 15 (specific locations in Exhibit A).

• Implementation/transition timeframe: no later than 90 days after award.

• Cost per Patient Reportable Result (CPRR) pricing model is required, covering equipment use, all reagents/supplies, maintenance, and training.

• Business Associate Agreement (BAA) required for entities handling Protected Health Information (PHI).

• Contractor must provide training for Government personnel.

• Characterization and documentation of hazardous waste produced by equipment and reagents are required.

• Contractor must comply with all applicable environmental regulations (EPA, RCRA).

• Equipment must be in current production and offered as new.

• Contractor is responsible for all hardware and software for interfacing with VA systems.

• Contractor must provide upgrades to hardware, interface, and software at no additional charge.

• Title to equipment remains with the Contractor; Contractor is responsible for removal upon expiration or termination.

Amendment / Modification

• This amendment provides answers to questions from offerors.

• It updates the Statement of Work (SOW) for clarification regarding security and connectivity documentation.

• The SOW is updated for clarification on security and connectivity documentation.

• This amendment does NOT extend quote submission deadlines.

• Quotes are still due on 01/23/2026 by 10:00 AM CST.

• The Point of Contact (POC) for this amendment is Erika Kobulnicky at Erika.Kobulnicky@va.gov.

Questions & Answers / Clarifications

This document provides responses to vendor questions regarding Solicitation 36C25526Q0120 for Cost-Per-Test (CPT) for Automated Erythrocyte Sedimentation Instruments, specifically addressing clarifications related to Amendment 0001.

• SOW Requirement Incompleteness: The government confirms the SOW sentence "Contractor shall provide that are applicable for remote connection to the interface system used to manage the testing system" is incomplete. The intent is for the contractor to provide all applicable documentation and agreements for remote connection, such as current ISA/MOU and BAA with the VA, if applicable. A BAA is not required for these specific instruments as they do not handle Protected Health Information (PHI). An MOU/ISA may be required depending on network connectivity.
• Pricing Structure: The requirement is for a firm-fixed-price BPA based on an all-inclusive Cost-Per-Test (CPT) price. This price should cover equipment use, all supplies, service, and training. Offerors must provide a firm-fixed per-test unit price for each CLIN and ordering period. Invoicing will be based on actual test results, not a fixed monthly amount per lab.

The solicitation will be updated to correct the incomplete SOW sentence. Offerors must adhere to the clarified requirements for documentation and pricing structure in their proposals. The core requirement for a Cost-Per-Test agreement remains unchanged.