Cepheid GeneXpert Supplies/CPT

NOTICE OF INTENT TO SOLE SOURCE REQUIREMENT

                                                            36C25025Q0597

The Department of Veterans Affairs, VA Healthcare System, VISN 10, Contracting activity intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR Part 6.302-1, Only One Responsible Source for the deliverables outlined below. The associated NAICS code for this is 325413. The business size is 1,250 employees. The vendor will be CEPHEID GENEXPERT. The Contractor shall provide all the below supplies to the Pathology and Laboratory Medicine Service at the Cincinnati VA Medical Center, 3200 Vine Street, Cincinnati, Ohio 45220. Reference Part II Section G Participating Facility. Description of the requirement:

VA Cincinnati Ohio Health Care Center

Cepheid GeneXpert Supplies/CPT – Statement of Work

FY 2025

Part I:  General Information

1.  Introduction:  The Microbiology section of Pathology & Laboratory Medicine Service at the Cincinnati Veterans Affair Medical Center requires a contract/certified invoice with Cepheid for MRSA NXG, C. diff, CT/NG, MTB, MVP, CARBA-R, DISPOSABLE SWAB, XPERT SWAB and COLLECTION KIT A URINE PCR cartridges and collection kits compatible with the Cepheid GeneXpert system. Cepheid GeneXpert is the only vendor to provide PCR testing cartridges for the Cincinnati VAMC GeneXpert equipment. Contracted vendor shall provide products of a quality meeting or exceeding current recognized national standards as established by The Joint Commission and College of American Pathologists. All software license costs and accessories required for operation, but not included with the system, need to be specified by the vendor. This must include all testing currently performed on this analyzer with the potential to add select testing as available and needed via amendment.  

1. Background:  The VA Cincinnati Medical Center is responsible for providing MRSA NXG, C. diff, CT/NG, MTB, MVP, CARBA-R, DISPOSABLE SWAB, XPERT SWAB and COLLECTION KIT A URINE PCR cartridges and collection kits testing services to our veteran patients and providers. The contract is to provide the supplies, reagents, maintenance and technical support required to continue running this equipment. This testing is performed on a Cepheid GeneXpert module system at the VA Cincinnati Medical Center.

1. Scope:  The vendor will provide supplies, reagents, and service as necessary to support operation of the Cepheid GeneXpert equipment at the Cincinnati VA Medical Center. This combined follow-on requirement for expired 36C25024P0721, and 36C25024P1041 will be for a one-year award. Due to time constraints a base and four-year option is not possible currently. Additional tests/reagents may be added to the order as new technology becomes available on the market by supplemental agreement of the Government and the Contractor. Supply and reagent volumes listed in section B.1.i may be increased or decreased by supplemental agreement of the Government and the Contractor.

1. Contractor must submit the following with the quote or the RFQ will be considered non-responsive:

1. Warranty information

2. Delivery terms

Part II:  Work Requirements

1. Technical Requirements: 
   1. The contractor shall have the capability of providing reagents, supplies, technical support, routine and non-routine maintenance services for the Cepheid GeneXpert instrument. The testing currently performed and reagents that must be available include:

1. 1. 1. C. difficile
      2. MRSA NXG
      3. CT/NG
      4. MTB
      5. MVP
      6. CARBA-R
      7. DISPOSABLE SWAB
      8. XPERT SWAB
      9. COLLECTION KIT A URINE PCR cartridges
      10. Collection kits compatible with the Cepheid GeneXpert

1. 1. The contractor shall provide reagents on a cost per test (CPT) basis.
   2. The contractor shall include routine and non-routine service as part of the CPT pricing.
   3. The contractor shall include all supplies required to perform the testing listed and obtain a reportable result in addition to reagents as part of the CPT pricing.
   4. The contractor shall have technical assistance available 24/7 by phone to assist with troubleshooting.
   5. The contractor shall provide routine and non-routine service during normal business hours.
   6. The testing must be performed using Polymerase Chain Reaction (PCR).
   7. The contractor will have to replace the Cepheid equipment and install their equipment.

1. Deliverables:
   1. Reagents and supplies will be delivered on the following schedule.
      1. Delivery Schedule: Cincinnati VA Medical Center

        SCHEDULE

DESCRIPTION

QTY

UNIT

PCR Cartridges for: MRSA SA Comp (10 test kit)

1100

CS

PCR Cartridges for: C. difficile (10 test kit) 

48

CS

PCR Cartridges for: CT/NG (10 test kit)

105

CS

PCR Cartridges for: MTB (10 test kit)

100

CS

PCR Cartridges for: MVP (10 test kit)

105

CS

PCR Cartridges for: CARBA-R (10 test kit)

10

CS

Collection kit for: Single-use disposable swabs (120)

20

CS

Collection kit for: XPERT swab (50)

50

CS

Collection kit for: Collection kitA urine (50)

25

CS

1. 1. Unanticipated delays in shipment will be communicated directly to the VA Cincinnati VAMC laboratory before the expected deliver time is exceeded.
   2. Telephone technical support will be available 24/7/365.
   3. On-site service will be scheduled within 24 hours when determined to be necessary.
   4. This agreement shall govern the terms and conditions and prices under which the contractor shall furnish, and the Federal Government shall order the testing supplies for Pathology and Laboratory Medicine Service at the Cincinnati VA Medical Center, 3200 Vine Street, Cincinnati, Ohio 45220.

1. PAYMENT

The Department of Veterans Affairs Financial Services Center (VAFSC) is the Designated Agency Office for all payments of invoice as defined in the Prompt Payment Act (PPA). Invoices need to be submitted to Austin, Texas via the OB10 system. Payment will be submitted through the IPPS system.

1. Pricing

The pricing for supplies is based on quotes provided from vendor.

1. Invoices

1. Extent of Obligation

The Federal Government is obligated only to the extent of authorized calls placed against this agreement. Only specific laboratory services shall be provided and those services only when ordered. The Federal Government will not order and shall not be obligated for medicines, supplies or equipment under this agreement. NOTE: The Federal Government will place calls to all contract agency when laboratory supplies are needed, the first contract agency to fill the need will be the one used.

1. Participating Facility:

Cincinnati Ohio VA HealthCare Center

3200 Vine Street

Cincinnati, Ohio 45220

1. Period of Performance: Follow-On award referencing 36C25024P0721, and 36C25024P1041 for April 15, 2025 – April 14, 2026.

A firm fixed price contract for one year is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source.

This notice of intent is not a request for competitive quotes or proposals. It is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government.Responses shall include: (1) Business Name and Address, (2) GSA, FSS etc. Contract Number, (3) Point of Contact Name, Phone Number and E-Mail Address (4) UEI (SAM) and NAICS code (5) Business Size (6) Type of Business.

Responses shall be submitted to Dwight Petsche, Contracting Officer, at dwight.petsche@va.gov no later-than Tuesday, May 27, 2025, at 12:00pm EST.