Notice of Sole Source Award and Redacted J&A - QuantiFERON TB Gold Plus ELISA Reference Lab Pack & QuantiFERON TB Gold Plus Tubes compatible with the Government –owned QFT

The Regional Health Contracting Office-Central (RHCO-C) is issuing this Sources Sought Notice to find potential sources to provide QuantiFERON TB Gold Plus ELISA Reference Lab Pack and the QuantiFERON TB Gold Plus Tubes compatible with the Government –owned QFT Gold Plus Assay System for the Brooke Army Medical Center (BAMC) Department of Pathology and Area Laboratory Services (DPALS) Immunology Section, JBSA Fort Sam Houston, Texas. The items are manufactured by Qiagen, Inc. A one-year base period of performance (1 October 2020 – 30 September 2021), plus four

(4) one-year option periods, are contemplated.

THIS IS NOT A SOLICITATION ANNOUNCEMENT – This is a Sources Sought Notice and is issued solely for information and planning purposes – it does not constitute a Request for Quote (RFQ) or a promise to issue an RFQ in the future. Solicitations are not available at this time and requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this Sources Sought Notice does not preclude participation in any future Request for Quote (RFQ), should one be issued. It is the responsibility of the potential offerors to monitor this site for additional information pertaining to this requirement.

The Government will use responses to this notice in formulating its acquisition strategy.  If the Government does not receive sufficient information in response to this notice to verify the potential for competition exists, it is possible that a sole-source contract, supported by a Justification and Approval document, will be issued to support the Government's requirement. RHCO-C is seeking the following information (please answer paragraph below with your response):

1. Company name, DUNS number, CAGE code, and point of contact information (including phone number and email address), and socio-economic category(ies) as related to NAICS 325413 (In-Vitro Diagnostic Substance Manufacturing), such as 8(a), HUBZone, Women-Owned, Service-Disabled Veteran-Owned, Small, or Other-than-Small.

2. Capability Statement (limited to ten pages), describing how your company meets the below objectives for Reagents / Consumables, providing additional proof (such as FDA approval) where appropriate:

- All assays shall be Food and Drug Administration (FDA) approved and must have a minimum shelf life of six (6) months upon receipt by the Government, or, if this shelf life requirement cannot be met the Contractor shall identify the guaranteed shelf life after receipt that can be accommodated in their response. Emergency orders will be delivered using overnight shipping, or, if this shipping requirement cannot be met, the Contractor shall identify the guaranteed emergency order shipping method that can be accommodated in their response.

-The manufacturer will provide the required quality control materials and test reagents and ensure that there is minimal change in lot numbers during the contract year.

- All reagents and quality control material shall be provided by the manufacturer of the equipment; be marked with the required storage temperature and expiration dates; be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the U.S. Government acceptance site and be delivered on time at the appropriate storage temperature.

- Preservation and packing - Preservation and packing shall be performed in accordance with the best commercial practices and in such a manner to afford adequate protection against any damage during shipment from source to destination.

- The reagents and quality control material must perform within the manufacturer’s stated/published package inserts. Deliveries of required items will be called in to the Contractor by the designated Contracting Officer’s Representatives. Orders will be delivered within five (5) business days of requested date of delivery.

- Must be able to meet the attached supply table:

Item Needed (BASE YEAR) (OPTION 1) (OPTION 2) (OPTION 3) (OPTION 4)

The response due date for this Sources Sought Notice is 4:00 PM CST, July 29, 2020. All questions and comments regarding this announcement shall be submitted via e-mail to the below POCs:

Awarded contract W81K00-20-P-0376 to unknown vendor for unknown amount on 2020-09-26.