6640--Allergy and Autoimmune Disease CPT Base +4 (TAM and BP)

Statement of Work (SOW)

To provide a cost-per-test (CPT) fully automated autoimmune analyzer testing system, reagents, supplies, and consumables for VISN 08 facilities (Tampa VA Healthcare Network and Bay Pines VA Healthcare System).

• Provide and maintain automated autoimmune analyzer testing systems, reagents, supplies, and consumables.

• Equipment required at two primary locations: James A. Haley Veterans Hospital (JAHVH) in Tampa, FL, and C.W. Bill Young VA Medical Center (CWBY VAMC) in Bay Pines, FL, with flexibility for expansion.

• The contractor is responsible for system installation, maintenance coordination, and supply procurement.

• Provide equipment and test kits meeting specified salient characteristics.

• Offer a comprehensive test menu including various allergy (IgE) and autoimmune disease tests, with estimated annual volumes provided for each facility.

• All-inclusive CPT pricing covers reagents, supplies, LIS interface, and potentially total lab automation connections.

• Reagent quality must meet College of American Pathologists (CAP) and The Joint Commission proficiency testing standards.

• Contractor must provide Standard Operating Procedures (SOPs) for all assays and equipment.

• Equipment must meet stringent performance criteria, including accuracy, linearity, precision, and sensitivity studies as defined by CLSI guidelines.

• Downtime is strictly defined, with penalties for prolonged or frequent equipment malfunctions.

• Acceptable performance is defined as operating within technical specifications without excessive downtime for 30 consecutive calendar days.

• Performance is required at the Tampa VA Healthcare Network (JAHVH) and Bay Pines VA Healthcare System (CWBY VAMC).

• The contract duration is not specified in this document, but requirements include ongoing maintenance, supply, and support.

• Equipment: New, state-of-the-art instrumentation is required, specifically mentioning Thermo Fisher Scientific – Phadia™ 250 Analyzer and AESKU.GROUP – Helios® HTC System for CWBY VAMC.

• Training: On- and off-site training for end-users and key operators is required.

• Service & Support: Full on-site technical support (Mon-Fri, 8am-5pm) and 24/7 telephone support with on-site response within 24 hours for emergency repairs.

• Data Management: System must interface with the Lab Information System (LIS) and comply with VA data security and privacy regulations.

• Security: Strict adherence to VA information security and privacy requirements, including background investigations for personnel accessing VA systems.

• Records Management: Compliance with Federal Records Act and NARA policies.

• No Minimums: No minimum monthly or annual purchase requirements; CPT is based on tiered volume.

• Delivery: Initial analyzer delivery within 14 days from the date of award.

Questions & Answers / Clarifications

This document provides responses to vendor questions regarding solicitation 36C24826Q0278.

• Solicitation Extension: An extension has been granted for solicitation 36C24826Q0278.
• Statement of Work (SOW): The SOW is included within the solicitation document itself.
• Additional Tests: For market research, the VA will obtain prices for additional tests. Vendors should provide pricing for these additional tests on a separate document, not within the provided Price Schedule template.

This Q&A document clarifies the availability of the SOW and provides instructions for submitting pricing for additional tests, potentially impacting proposal preparation.

Amendment / Modification

• The deadline for receipt of offers has been extended.

• The purpose of this amendment is to provide Questions and Answers.

• See attached document: Questions and Answers.

• See attached document: Allergy Immunoassay Disease Testing SOW.

• Solicitation Number: 36C24826Q0278

• Original Offer Due Date: Not specified, but extended.

• New Offer Due Date: February 10, 2026, 9:00 AM EST.

• The hour and date for receipt of offers is extended to February 10, 2026, 9:00 AM EST.

Amendment / Modification

This amendment (Number 0001) to Solicitation 36C24826Q0278, dated January 28, 2026, serves to provide an updated Price Schedule. All other terms and conditions of the original solicitation remain unchanged.

• Price Schedule (updated)

Bidders should ensure they are using the updated Price Schedule when preparing their offers. No changes to proposal deadlines or evaluation factors are indicated by this amendment.

Solicitation / RFP / RFQ

This solicitation, identified by Solicitation Number 36C24826Q0278, is for the provision of a fully automated autoimmune analyzer testing system on a cost-per-test (CPT) basis. The acquisition is being conducted by the Department of Veterans Affairs, Network Contracting Office 8 (NCO 8).

• Provision of a fully automated autoimmune analyzer testing system.

• Cost-per-test (CPT) pricing structure.

• The schedule of supplies/services details numerous specific IgE tests and antibody tests, indicating a broad range of diagnostic capabilities required.

• Contract Type: Firm-Fixed-Price, Indefinite Quantity.

• Period of Performance: Base period from 02-09-2026 to 02-08-2027, with four (4) one-year option periods extending through 02-08-2031.

• NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing.

• Product/Service Code: 6640 - Laboratory Equipment and Supplies.

• Offer Due Date: February 5, 2026, 9:00 AM EST.

• Questions Due: January 30, 2026, 5:00 PM EST.

• Submission Method: Email to paul.jarrett@va.gov.

• Evaluation Approach: Technical Acceptability, Past Performance, and Price. Technical acceptability is a go/no-go factor. Past performance is more important than price.

• Key Submission Components: Signed SF1449, completed Contract Administration Data, completed Price Schedule with unit prices for all line items and option periods, and necessary items for CPT compliance (Packaging Structure, Unit Price, Manufacturer Part Number, Item Part Number, OEM Name).

• The acquisition is listed as "UNRESTRICTED" but includes specific clauses related to small business concerns (e.g., 52.219-8, Utilization of Small Business Concerns).

• FAR clauses 52.212-1, 52.212-4, and 52.212-5 are incorporated by reference or attached.

• The document includes extensive pricing schedules for various tests across multiple contract periods.

Solicitation / RFP / RFQ

This solicitation is for a cost-per-test (CPT) fully automated autoimmune analyzer testing system, including reagents, supplies, and consumables. The system must be capable of performing FDA-approved patient testing for VISN 08 facilities, specifically the Tampa VA Healthcare Network (TVAHCN) and the Bay Pines VA Healthcare System (BPVAHCS), within the Department of Pathology and Laboratory Medicine Service (P&LMS).

• A fully automated autoimmune analyzer testing system.

• Associated reagents, supplies, and consumables.

• Capability to perform FDA-approved patient testing.

• Equipment to be installed in at least two separate locations: James A. Haley Veterans Hospital (Tampa, FL) and C.W. Bill Young VA Medical Center (Bay Pines, FL).

• Flexibility to expand testing and add instrumentation to future locations within the VISN Healthcare Network as needed.

• Product Service Code (PSC): 6640

• NAICS Code: 334516

• Response Date/Time/Zone: February 5, 2026, 09:00 Eastern Time, New York, USA.

• Not specified in the provided text.

• The contracting office is located in Tampa, FL (ZIP Code 33637).

• The Point of Contact is Paul Jarret (paul.jarrett@va.gov).