6515--Qiagen Brand Name Molecular Testing Reagents KRAS RGQ PCR, EGFR RGQ PCR, BRAF RGQ PCR, and IDH1/2 RGQ PCR VA Pittsburgh Healthcare System 60 Month BPA Agreement

SOURCES SOUGHT NOTICE: The Department of Veterans Affairs, Network Contracting Office 4 (NCO 04), is conducting a market survey to identify potential sources to provide Qiagen Brand Name Molecular Testing to the VA Pittsburgh Healthcare System University Drive, Pittsburgh, PA 15240.

This notice is issued for informational planning purposes only and is not a request for quote or announcement of a solicitation. Submitting information for this notice is voluntary and VA assumes no responsibility for any costs incurred associated with the preparation of responses submitted as a result of this notice. No solicitation is available at this time. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.

The purpose of this market research is to identify capable sources that are both experienced and qualified to provide Qiagen Brand Name Molecular Testing to the VA Pittsburgh Healthcare System in accordance with the performance work statement. THE VENDOR MUST BE ABLE TO SHIP THE MATERIALS WITHIN 3 BUSINESS DAYS OF ORDERING.

The North American Industry Classification System Code (NAICS) is 339112 Pharmaceutical Preparation Manufacturing, and the small business size standard is 1000 employees for this type of effort.

Vendors must be registered in the System for Award Management (SAM) at https://www.sam.gov and shall complete electronic annual representations and certifications in SAM prior to award of contract. If you are responding as a Service-Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses (SDVOSB s and VOSB s), your company must be registered in VetCert and maintain a current certification (Veteran Small Business Certification (sba.gov).

CAPABILITY STATEMENT AND DOCUMENTATION:

Companies are to provide a summary of your firm s capabilities, experience, and knowledge in providing these services. Sources are asked to provide the following information:

1. Company information:

Company Name

Company Address

Company uei SAM

Company NAICS Code(s)

Point of Contact Name

Point of Contact Phone Number

Point of Contact Email Address

Company Website (if available)

2. The North American Industry Classification System Code (NAICS) is 339112 Analytical Laboratory Instrument Manufacturing, and the small business size standard is 1000 employees.

Based on this information, please indicate whether your company is a:

Service-Disabled Veteran Owned Small Business (SDVOSB)

Veteran Owned Small Business (VOSB)

8(a)

HUB Zone Small Business

Women Owned Small Business

Small Disadvantaged Business (SDB)

Small Business Concern

Large Business

3. Provide a summary of your firm s Ability/ Capability to meet the services described in this notice (see attached SOW).

4. Government contracts for these services in the last 3 years. Include:

Government Agency

Contract Number

Dollar Value

Period of Performance

Government Point of Contact Information (name, email, phone number)

Information regarding your company s capacity and capability to provide such services are to be submitted electronically on or before Monday, 07/28/2025 at 4PM EST addressed to Christa Stine, Contract Specialist christa.stine@va.gov.

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

VA Pittsburgh Health System

INTRODUCTION AND SCOPE

OVERVIEW

The purpose of the VA Pittsburgh Healthcare System requirement is to provide best value professional and healthcare for the molecular anatomic pathology department.

SCOPE

The contractor shall provide all resources necessary to accomplish the deliverables described in this Performance Work Statement (PWS) by supplying reagents, quality control materials, linearity and validation reagents, for testing and detecting mutations in biomarkers associated with specific types of cancer in our molecular anatomic pathology department. These reagents are KRAS RGQ PCR, EGFR RGQ PCR, BRAF RGQ PCR, and IDH1/2 RGQ PCR. The reagents must be Qiagen Brand Name to be compatible with the Rotor-Gene Q MDx analyzers proprietary software that we currently have onsite at VA Pittsburgh Healthcare System.

GENERAL INFORMATION

Type of Contract

The U.S. Department of Veterans Affairs, Pittsburgh VA Medical Center anticipates an agreement for the procurement of reagents for molecular anatomic pathology department for detecting mutations in biomarkers associated with specific types of cancer. The mutations are linked to resistance to therapies and their understanding and presence are crucial for guiding treatment decisions and improving patient outcomes.

Contract Ordering Period

The agreement for procurement of reagents for our molecular anatomic pathology department will consist of a 60 Month BPA Agreement, funded with 12- month Task Orders. The performance period will commence upon the Contracting Officer s signature and will expire within one (1) year unless canceled, terminated, or extended.

Place of Performance

The place of performance will be VA Pittsburgh Healthcare System, University Drive C, Pittsburgh, PA 15240.

SERVICE GROUPS AND LABOR CATEGORIES

General Requirements

Contractor personnel shall have the level of experience necessary to accomplish the requirements of this PWS. In addition, contractor personnel should be acceptable to the Government in terms of personal and professional conduct, and technical knowledge. Furthermore, contractor personnel are expected to be proficient in using office automation equipment and software and have sufficient written and verbal communication skills to support VA program offices, their customers, and any other VA organizations. Should any contractor personnel be determined to be unacceptable in terms of technical competency or unacceptable conduct or behavior while on-site or while working on contract activities, the contractor shall immediately remove and replace the unacceptable on-site

personnel at no additional cost to the Government. Contractor personnel are to serve in a support role; therefore, final decisions regarding inherently governmental functions will always be made by Government personnel. General and technical requirements:

General Specifications:

The vendor must provide the reagents, quality control materials, linearity, and validation materials needed to perform testing in molecular anatomic pathology for KRAS RGQ PCR, EGFR RGQ PCR, BRAF RGQ PCR, and IDH1/2 RGQ PCR.

Shipping, handling, and freight charges will be the responsibility of the contractor.

Materials with the longest outdates will be shipped according to the needs of the Molecular Anatomic Pathology department.

All substitutions for expired or unavailable reagents must be provided by the company at no additional costs.

Materials will be scheduled for shipment according to the needs of the Anatomic Pathology department.

All reagents will be delivered to the dock area of:

VA Pittsburgh Healthcare System

University Drive

Pittsburgh, PA 15240

Materials will be shipped within 3 business days of ordering.

The Molecular Anatomic pathology supervisor/designee will be the individual designated to order against this contract.

Printed MSDS/SDS will be available upon request.

DELIVERABLES

The contractor shall provide all deliverables identified in the Performance Work Statement (PWS).

All deliverables shall be compliant with Section 508, 1998 Amendment to the Rehabilitation Act of 1973 according to the requirements for each such delivery.

Below are estimated quantities per year. Exact amounts cannot be guaranteed.

Task

Qty

Therascreen KRAS RGO PCR

9

Therascreen EGFR RGO PCR

8

BRAF RGQ PCR (24) V2

10

IDH ½ RGQ PCR (20)

2

SECURITY AND PRIVACY REQUIREMENTS

All Contractors and Contractor personnel shall be subject to the same Federal security and privacy laws, regulations, standards, and VA policies as VA personnel, including the Privacy Act, 5 U.S.C. § 552a, regarding information and information system security. Contractors must follow all security and privacy requirements, per Attachment C - VA Information and Information System Security/Privacy Requirements.

In accordance with VA policy, contractors storage, generation, transmission or exchanging of VA sensitive information is not involved with this procurement. The contractor will not have access to the VA server and therefore do not have access to VA sensitive information.