Laboratory Accreditation Services

A.2 COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C10G25R0041 Posted Date: July 2, 2025 Question Response Date: July 15, 2025 Current Response Date: July 25, 2025 Product or Service Code: R420 Set Aside: N NAICS Code: 813920

A.3 GENERAL INFORMATION Contracting Office Address: Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave, Suite 400 Fredericksburg, VA 22408

Description: This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a written solicitation document will not be issued. The associated North American Industrial Classification System (NAICS) code for this procurement is 813920, with a small business size standard of $23.5M.

This solicitation is a Request For Proposal (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-04 published in the Federal Register on June 11, 2025.

Type of Contract: The Government will award a single vendor a Firm Fixed Price (FFP), Indefinite-Delivery, Indefinite Quantity (IDIQ) contract that will be most advantageous to the Government, price and other factors considered. Number of Contracts to be Awarded: The Government intends to select one contractor for this acquisition. However, the Government reserves the right not to award a contract at all, depending on the quality of the proposals and prices submitted and the availability of funds. Acquisition Office: The Office of Procurement, Acquisition and Logistics, Strategic Acquisition Center, 10300 Spotsylvania Ave, Suite 400, Fredericksburg, VA 22408.

Please see attached solicitation and documents for complete details on this requirement, as follows.

1. 36C10G25R0041 Solicitation Laboratory Accreditation Services.

Attachment 1 -Technical Exhibit A- VHA Accreditation Facilities List

Attachment 2 - Sample Business Associate Agreement

Attachment 3 - Question Submission Format

Attachment 4 - Sample Price/Cost Schedule

Questions relating to this solicitation shall be emailed to the Contracting Specialist (CS): Nicole Lowther, Nicole.Lowther@va.gov, and the Contracting Officer (CO): Rodney Burgos-Cabassa, Rodney.BurgosCabassa@va.gov. All questions shall be submitted in writing in accordance with the Request for Proposal (RFP). All questions shall be submitted on Attachment 3 RFP Questions via email. Only written questions submitted using Attachment 3- RFP Questions (one document per Contractor) will be accepted. All questions are due on July 15, 2025 at 3:00 PM EST.

Background
The U.S. Department of Veterans Affairs (VA), through the Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC), is issuing this solicitation for Laboratory Accreditation Services. The VA's mission is to provide high-quality healthcare services to veterans. This contract aims to ensure that laboratory facilities meet necessary standards for providing accurate and reliable diagnostic testing and medical services. The contractor will be responsible for conducting audits and continuous monitoring to maintain compliance with federal regulations, specifically under the Clinical Laboratory Improvement Amendments (CLIA).

Work Details
The contractor shall provide laboratory accreditation services for Veterans Health Administration (VHA) clinical laboratories and community-based outpatient clinics (CBOCs) that perform moderate and/or high complexity testing. Key tasks include:

1. Conducting biennial on-site audits and continuous monitoring services for laboratory accreditation.
2. Auditing laboratory services through direct observations and record reviews against federal requirements.
3. Assessing compliance with applicable regulations such as 42 C.F.R. Part 493 and VHA Directive 1106.
4. Evaluating corrective actions for non-conformance identified during audits.
5. Providing information on best practices in laboratory operations.
6. Investigating quality complaints related to audit elements.
7. Making final determinations of accreditation status for each audited location.

Period of Performance
The contract will have a base period of performance of 12 months, with four optional periods of 12 months each, allowing for a total potential duration of up to five years.

Place of Performance
The work will be performed at VHA facilities nationwide requiring audit under this contract, through virtual meetings, and at the contractor’s facility.