H265--Requirement Title: Provide testing and certification of the Pharmacy Sterile Compounding suite and equipment.

Form / Attachment / Pricing Sheet

This document is a "VA Notice of Limitations on Subcontracting—Certificate of Compliance for Services and Construction." It requires offerors to certify their compliance with subcontracting limitations if awarded a contract. This is a mandatory certification for the offeror to complete and return with their bid, quotation, or proposal.

• Services: If the contract is for services, the contractor must certify that they will not pay more than 50% of the contract amount to firms that are not VIP-listed Service-Disabled Veteran-Owned Small Businesses (SDVOSBs) or Veteran-Owned Small Businesses (VOSBs). Certain costs (other direct costs not the principal purpose of the acquisition) may be excluded.
• General Construction: For general construction contracts, the contractor must certify that they will not pay more than 85% of the contract amount to non-VIP-listed SDVOSBs or VOSBs. Costs of materials are excluded.
• Special Trade Construction: For special trade construction contracts, the contractor must certify that they will not pay more than 75% of the contract amount to non-VIP-listed SDVOSBs or VOSBs. Costs of materials are excluded.
• Certification Statement: Offerors must sign and date the certification, confirming their understanding and agreement to comply with the limitations.
• Penalties: False certifications are subject to criminal, civil, or administrative penalties, including prosecution under Title 18, United States Code, Section 1001.

This document is critical for bidders to understand the subcontracting restrictions applicable to the opportunity. Failure to complete and submit this certification with the offer will result in the offer being deemed ineligible for evaluation and award. Bidders must carefully review the applicable percentage limitations based on the contract type (services, general construction, or special trade construction) and ensure their proposed subcontracting plan adheres to these requirements. The VA may require documentation to verify compliance during contract performance.

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

To ensure the comprehensive testing and certification of all sterile compounding hoods and rooms at the VA Western Colorado Health Care System in Grand Junction, CO, maintaining compliance with applicable standards and ensuring a safe environment for medication preparation.

Engage a CETA-certified contractor to provide all necessary labor, equipment, and software for testing and certification of the Pharmacy Sterile Compounding suite and associated equipment. This includes:

• Non-viable and viable testing and certification of one Compounding Aseptic Containment Isolator (CACI).
• Non-viable and viable testing and certification of one Compounding Aseptic Isolator (CAI).
• Non-viable and viable testing and certification of one Laminar Airflow Workbench (LAFW).
• Pressure differential and air exchange testing of one Containment Segregated Compounding Area (C-SCA). Tests must comply with CETA standards, USP Chapters <797> and <800>, and current NSF standards.

Inspections are to be performed semi-annually. Specific testing requirements include airflow, pressure, HEPA filter integrity, viable and non-viable particle counts, and visualization studies. Documentation of services, including test results, equipment identification, and technician certifications, is required.

• Base Year: 05/15/2026 through 05/14/2027

• Option Years 1-4 extend through 05/14/2031.

• Location: VA Western Colorado Health Care System, Grand Junction, CO.

• Normal hours of operation are Monday-Friday, 0800-1700, with potential for work outside these hours upon approval.

• Contractors must be CETA certified.

• Technicians must be CETA certified.

• Contractor shall furnish all necessary parts and consumables.

• Contractor shall provide all tools, test equipment, manuals, and diagnostic software.

• Invoices must include specific details and require CO approval for additional charges.

• Adherence to VA safety regulations, including identification, no tobacco use on property, and prohibition of firearms.

• Contractor employees will be escorted by agency personnel and may require passes from the VA Police Department.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation (Request for Quote - RFQ) for commercial items to provide testing and certification of the Pharmacy Sterile Compounding suite and equipment for the Grand Junction VA Medical Center. The government anticipates awarding a firm-fixed-price contract.

• Provide testing and certification of the Pharmacy Sterile Compounding suite and equipment.

• Detailed requirements are outlined in Attachment 1 - Performance Work Statement (PWS).

• Services are to be delivered F.O.B. Destination to the Western Colorado Health Care System in Grand Junction, CO.

• Contract Type: Firm-Fixed Price.

• Period of Performance: BASE + 4 YEARS.

• The total duration, including options, shall not exceed 5 years.

• Response Date/Time: May 12, 2026, 08:00 AM EST.

• Questions Deadline: May 11, 2026, 12:00 PM MST.

• Submission Method: Email quotes only to kenneth.finchum@va.gov (4MB email limit). Faxed or hand-carried quotes will not be accepted.

• Evaluation Factors:

  1. Technical capability or quality
  2. Price
  3. Past Performance
  4. VA Notice of Limitations on Subcontracting - Certificate of Compliance

• Award will be made on an "All or Nothing" basis.

• This solicitation is 100% set-aside for Service-Disabled Veteran-Owned Small Businesses (SDVOSB).

• SDVOSB status must be verified in the SBA Small Business Certification (SBS) database at the time of quote submission and award.

• NAICS Code: 541380 (Testing and Certification Laboratories) with a business size standard of $19 MILLION.

• Offerors must submit quotes in four volumes: Technical Capability, Price, Past Performance, and Limitations on Subcontracting Certificate.

• See Attachment 2 for the Price Schedule and Attachment 3 for the VA Notice of Limitations on Subcontracting.