Inactive
Notice ID:W81K00-20-Q-0132
The Regional Health Contracting Office-Central (RHCO-C), Joint Base San Antonio Health Contracting Branch, is issuing this Sources Sought Notice to find potential sources to provide reagents for the I...
The Regional Health Contracting Office-Central (RHCO-C), Joint Base San Antonio Health Contracting Branch, is issuing this Sources Sought Notice to find potential sources to provide reagents for the Immunology Section, Department of Pathology and Area Laboratory Services, Brooke Army Medical Center (BAMC), Joint Base San Antonio (JBSA) Fort Sam Houston, Texas. Reagents must be compatible with Government-owned equipment, manufactured by GenMark Diagnostics. A base period of performance of 1 October 2020 – 30 September 2021 plus four (4) twelve-month 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 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, providing additional proof (such as FDA approval) where appropriate: a. Provide reagents and any consumables that are compatible with the GenMark Diagnostics eSensor XT-8, for genetic testing of Thrombophilia, Cystic Fibrosis, and Hepatitis C with following specifications: - Thrombophilia: Detect all four (4) Thrombophilia-related genetic markers: ? Factor II (Prothrombin FII) ? Factor V (Leiden, FV) ? MTHFR 677 ? MTHFR 1298 - Cystic Fibrosis Panel must include the 23 recommended mutations established in the guidelines from the American College of Medical Genetics and American College of Obstetricians and Gynecologists - Hepatitis C Type and subtype Hepatitis C virus (HCV) 1a, 1b, 2, 2a/c, 2b, 3, 4, 5, and 6 - Must have the ability to detect genetic anomalies from a single specimen - Must have quality control standards that meets or exceeds all laboratory accreditation requirements. b. All assays shall be Food and Drug Administration (FDA) approved for genetic testing, OR provide any exceptions. Assays 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 to the Solicitation for Bid. c. The manufacturer will provide any quality control materials and test reagents and ensure that there is minimal change in lot numbers during the contract year. d. 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. e. 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. f. 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 Ordering Officers appointed by the Contracting Officer. Orders will be delivered within five (5) business days of requested date of delivery. g. The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall contain at a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident. The response due date for this Sources Sought Notice is 4PM CST, June 17, 2020. All questions and comments regarding this announcement shall be submitted via e-mail to the below POCs:
