Attach 01 Statement of Need.docx

Statement of Need For Cepheid Test Kits and Supply At Duty Stations supporting the Veterans Integrated Service Network 4 (VISN4)

1. Introduction/Background. The Cepheid instruments maintained by the Veterans Integrated System Network 4, VISN4, provide the network the capability to rapidly identify pathogenic organisms from patient specimens in a timely manner. Cepheid is also one of the few known manufacturers of COVID 19 test kits that produce rapid results on the commercial marketplace. These capabilities enable Network healthcare providers the ability to make informed decisions about treatment.

2. Objective. This is a Fixed Price Indefinite Delivery Indefinite Quantity Contract with a two year and/or attaining the maximum dollar value of $4,840,000.00. VISN4 has a requirement for Cepheid Test Kits and Products for duty station within the service area. Shipment of deliverable items, other than reports, shall be to multiple duty station within the VISN4 service area:

2.1 Duty Station 1: Altoona VA Medical Center, 2907 Pleasant Valley Boulevard, Altoona, PA 16602-4377, United States.

2.2 Duty Station 2: VA Butler Healthcare, 325 New Castle Road, Butler, PA 16001-1138, United States.

2.3 Duty Station 3: Coatesville VA Medical Center, 1400 Black Horse Hill Road, Coatesville, PA 19320-2096, United States.

2.4 Duty Station 4: Erie VA Medical Center, 135 East 38th Street, Erie, PA 16504-1559, United States.

2.5 Duty Station 5: Lebanon VA Medical Center, 1700 South Lincoln Avenue, Lebanon, PA 17042-7529, United States.

2.6 Duty Station 6: Philadelphia VA Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104-4551, United States.

2.7.1 Duty Station 7A: VA Pittsburgh Healthcare System, University Drive Campus, University Drive C, Pittsburgh, PA 15240-1003, United States.

2.7.2 Duty Station 7B: VA Pittsburgh Healthcare System, HJ Heinz Campus, 1010 Delafield Road, Pittsburgh, PA 15215-1802, United States.

2.8 Duty Station 8: Wilkes-Barre VA Medical Center, 1111 East End Boulevard, Wilkes-Barre, PA 18711-0026, United States.

2.9 Duty Station 9: Wilmington VA Medical Center, 1601 Kirkwood Highway, Wilmington, DE 19805-4917, United States.

3. Performance Requirements.

3.1 Minimum and Maximum Ordering Amounts. This is an indefinite-delivery, indefinite quantity contract for Cepheid Test Kits and Supplies in accordance with the Statement of Need. Requirements will be issued as firm-fixed-price delivery orders against this contract. In accordance with FAR 52.216-22, the minimum dollar guarantee is $190,000.00. The maximum dollar ceiling that the Government may order over of the life of this contract shall not exceed $4,840,000.00. The quantity delivered will be dependent on the delivery order placed by the Government. For pricing purposes, the Contract Line Item Numbers (CLINs) show one unit; however, more than one unit may be ordered.

3.2 Extent of Obligation. The Government is obligated only to the extent of authorized purchases actually made under the resultant contract. The terms and conditions included in this contract apply to all purchases made pursuant to it.

3.3 Purchase/Ordering Limitation. Orders placed against this agreement are limited to FAR Clause 52.216-19 Order Limitations, as noted in the contract.

3.4 The contractor shall provide manufacturer’s warranty information for each product listed with the Contract Line Items Numbers for all provided equipment so that the manufacturer’s warranty can be put in place. Additionally, the contractor shall warranty the entire system. The contractor will be responsible for providing continuity of all warranties and will ensure transfer of all warranties to VA is completed.

3.5 Individuals Authorized to Purchase Under the Contract. Network Contracting Office 04 Contracting Officers, with direct ordering authority on behalf of VA, will place individual delivery orders established on this contract.

3.6 Shelf Life: Any product with a shelf life or an expiration date shall have no less than six months shelf life/expiration dating remaining upon delivery to the Government, unless the customer authorizes a product with a shorter shelf life. On Xpert Xpress SARS-CoV-2/Flu/RSV and Xpert Xpress SARS-CoV-2 Test Kits with an initial expiration date or shelf life of less than six months, at least 50% shelf life dating shall remain at time of delivery to the ordering facility. The contractor’s product return policy and capability may be required upon award.

3.7 Contractor error and shipping damage: The contractor shall accept return of product for replacement or credit for defective product, product shipped in error, short shelf life or any other condition necessitating the return when such condition was caused by the contractor. The COR shall notify the contractor within two business days of receipt of shipping damage, including concealed shipping damage, Xpert Xpress SARS-CoV-2/Flu/RSV and Xpert Xpress SARS-CoV-2 Test Kits with an initial expiration date or shelf life of less than six months, and at least 50% shelf life dating shall remain at time of delivery to the delivery location.

3.8 Delivery orders for these items will be placed by the cognizant Contracting Officer upon receipt of actionable acquisition package(s) from the Duty Station(s).

3.9 Deliveries will be required within 7 day after receipt of delivery order unless otherwise specified on the delivery order.

3.10 Confirmation of delivery will be made through the Logistics Departments of the 9 duty stations specified in paragraph 2.

3.11 Contract type was selected as the Government cannot adequately predict the exact number of reagents that will need to be delivered in any given period of time. The quantities of reagents specified below are estimates only.