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

To outline the tasks and responsibilities for providing reagents, consumables, and services to support infectious disease testing on Roche Cobas 5800 systems for VISN 22 sites.

• The contract will have a base period of 1 year with four 1-year options.

• Services will support multiple VA facilities within VISN 22, with the possibility of adding or deleting facilities via supplemental agreement.

• The contractor must provide a continuously stocked inventory of high-quality reagents, standards, controls, supplies, and disposables for the Roche Cobas 5800 systems.

• Items must be FDA cleared and compatible with the VA-owned Roche Cobas 5800 instrument.

• Specific assays required include HIV-1 Viral Load, Hepatitis C Viral Load, Hepatitis B Viral Load, CT/NG, HPV, SARS-CoV-2, SAR-CoV-2/flu A/B/RSV, TV/MG, HIV 1/2 Qualitative, CMV Viral Load, EBV Viral Load, and BKV Viral Load.

• Reagents must be ready-to-use, require minimal calibration, have a minimum 6-month expiration date, and be compatible with RFID tracking.

• Assayed quality control material (minimum three levels for quantitative, two for qualitative) must be supplied.

• The contractor must supply reagents and consumables for third-party assay testing for Candida auris.

• Special handling for emergency orders of defective or undelivered supplies requires delivery within 24 hours.

• Equipment must achieve an effectiveness level of 90% or more for 30 consecutive calendar days during an acceptance period.

• Equipment must maintain a minimum uptime of 90% each month.

• Technical assistance center available 24/7 with a 1-hour callback response time.

• Equipment repair response time no more than 24 hours.

• Preventative maintenance frequency as per manufacturer's manual, within 2 weeks of the scheduled date.

• Malfunction incident reports required after each repair.

• Base period of 1 year with four 1-year options.

• Services to be performed at various VISN 22 facilities.

• Implementation and transition to be completed within 90 days of contract award.

• Cost Per Kit (CPK) pricing model includes reagents, consumables, parts, accessories, training, and maintenance (preventive and emergency repairs billed separately).

• Contractor responsible for delivery, installation, and removal of equipment at no additional charge.

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

• Staff performing maintenance must be Roche trained and certified.

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

• Contractor responsible for all ancillary support equipment and interface requirements.

• Characterization and documentation of hazardous waste produced by equipment and reagents are required, adhering to EPA and state regulations.

• Written instructions and training for VHA laboratory staff on operation and hazardous waste disposal are required.

• Contractor must provide documentation on waste characteristics (toxicity, ignitability, corrosivity, reactivity) and compliance with discharge requirements.

• Data security and media sanitization requirements must be followed, adhering to VA Directives and Handbooks.

Form / Attachment / Pricing Sheet

This document, "Attachment A - Price Schedule.xlsx", provides the detailed pricing structure for the opportunity. Bidders are expected to use this format to submit their pricing proposals.

The price schedule is organized by CLIN (Contract Line Item Number) and includes various viral load tests (HIV-1, Hepatitis C, Hepatitis B, CT/NG, HPV, SARS-CoV-2, etc.) as well as a general 'Service' CLIN. For each item, it outlines:

• Brand Name Nomenclature
• Manufacturer Part Number
• Minimum System Requirements (referencing Attachment B)
• Equivalent Brand, Nomenclature, and Part Number fields (for potential substitutions)
• Equivalent Description Matching Salient Characteristics
• Quantity (Units/Year or Est. Annual Test Volume)
• Unit of Measure (UoM)
• Tests/Kit

• of Kits - 1 Year Total

• Price Per Kit
• Cost-Per-Test Price
• Extended Price

It includes sections for a Base period and four Option periods, detailing estimated annual test volumes and pricing components for each. A 'Total Amount' sheet summarizes the estimated annual prices for each period. A 'Separately Priced Items' sheet lists an 'Evalyn Brush' with an item number.

Bidders must carefully review and complete this price schedule to accurately reflect their proposed costs for all CLINs across the base and option periods. The details provided here are crucial for proposal preparation and will be a key factor in the evaluation of pricing. Note that all price-related fields are currently populated with '0.0', indicating that bidders must input their specific pricing. The reference to 'Attachment B' for minimum system requirements and salient characteristics suggests that further details influencing pricing are available in that document.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation (Request for Quotation - RFQ) for commercial items, prepared in accordance with FAR Part 13 Simplified Acquisition Procedures. The Department of Veterans Affairs (VA), Network Contracting Office 22, intends to award a single Firm-Fixed Price (FFP) Indefinite-Delivery Indefinite-Quantity (IDIQ) contract for a Roche 5800 CPT system. The contract will be for a one-year base period with four one-year option periods.

• Procurement of a Roche 5800 CPT system.

• Offerors must demonstrate meeting the salient physical, functional, or performance characteristics specified in Attachment B – Statement of Work.

• Supplies and services are to be delivered to multiple VA facilities within VISN 22 (listed in the document).

• Standard orders are to be delivered within four (4) working days; emergency deliveries may be required.

• Contract Type: Firm-Fixed Price (FFP) IDIQ.

• Period of Performance: One (1) year base period plus four (4) one-year option periods (totaling up to 66 months).

• Guaranteed Minimum Award: $300.00.

• Maximum Aggregate Value: $7,500,000.00.

• Maximum Order Limit: $2,000,000.00 per single item/order.

• Response Date/Time: February 19, 2026, 10:00 AM Pacific Time, Los Angeles, USA.

• Questions Deadline: February 12, 2026, 8:00 AM Pacific Time.

• Submission Method: Email to Clift.Domen@va.gov, referencing solicitation number 36C26226Q0313.

• Evaluation Criteria: Lowest priced quotation that meets all minimum system requirements, is responsive, and responsible. Equal-to items must clearly demonstrate they meet salient characteristics.

• Full and Open competition.

• NAICS Code: 325413 (In Vitro Diagnostic Substance Manufacturing).

• Size Standard: 1,250 employees.

• Offerors must submit a completed Attachment A – Schedule of Pricing and Attachment B – Statement of Work.

• Offerors must include informational brochures and details on reagent sizes/testing capacity as specified.

• Failure to acknowledge amendments may result in rejection of the offer.