Sources Sought Notice - Ortho Vision - Traditional Immunohematology Testing Reagents
The Regional Health Contracting Office-Central (RHCO-C) is issuing this Sources Sought Notice to find immunohematology testing reagents compatible with the ORTHO VISION analyzer used to support the mission of Transfusion Services Section of the Department of Pathology and Area Laboratory Services (DPALS) at the Brooke Army Medical Center, JBSA - Fort Sam Houston, TX 78234. A base period of performance of twelve (12) months plus four (4) twelve (12) 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):
- 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.
- Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate:
- Our customer, DPALS, Transfusion Services Section at the main hospital located at BAMC require the following immunohematology testing reagents:
- The Contractor shall provide, as outlined below reagents that support ORTHO VISION immunohematology analyzers listed in Table 1.
- All components outlined will supplied through a single Contractor (to whom the contract is awarded), including supplies not manufactured or provided by the Contractor.
- Analytical reagents must be approved by the Food & Drug Administration (FDA).
- All costs for immunohematology testing will be calculated based on the annual volume listed in Table 1.
- The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States or the Contractor’s representative Government.
- The MSDS shall contain information on the hazards associated with each specific chemical or material.
- The MSDS shall be printed in the English language and shall contain, as a minimum, identification of:
- The hazardous material
- The specific hazard
- The required practices for the safe use of the product
- First aid procedures
- Description of actions in the event of a spill or other mishap or accidents
- Reagents/Material. All reagents provided shall be identical to those used in the FDA 510K approval application. All reagents/reagent packs shall be provided as follows:
- Meet the reagent requirements specified by the manufacturer of the equipment; ORTHO VISION manufactured by Ortho Clinical Diagnostics.
- Reagents must have a minimum unopened shelf-life of six (6) months, and controls must have a minimum unopened shelf life of at least one (1) month upon receipt by the Government.
- If this shelf-life requirement cannot be met, the Contractor shall (must) identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Proposal/Request for Quote.
- The Contractor shall sequester the required quality control materials and test reagents where possible.
- Be marked with the required storage temperature.
- Inclusive of an English language package inserts.
- If bulk reagents are produced overseas, they will be manufactured in conformance with ISO or CE standards AND must be equal to or better than the U.S. products in quality/manufacturing. Documentation of item equivalency must be provided.
- Shipment and Deliveries. The Contractor will provide, upon shipment, an electronic tracking mechanism whereby the Government is able to identify the shipping status of any reagents or materials.
- Deliveries of required items must be in monthly drop shipments or as called in by the COR or ACOR. Large items should be shipped in a split order to arrive 2 weeks apart.
- Orders must arrive no later than one week from the requested date/designated delivery date.
- Any supplies that are placed on back order shall be communicated electronically to the Government, clearly identified on the shipping documents, and delivered in a timely manner, not to exceed ten (10) working days.
- In the instance a back-order exceeds 10 working days, the Contractor must provide testing services through local sub-contract at their cost.
- Routine or scheduled orders will arrive no earlier than one week before or later than one week after the scheduled date of delivery.
- Emergency orders will be delivered within 24 hours after the order is placed.
- An alternate quality control material must be provided by the contractor if the new lot of controls cannot be delivered one week prior to the expiration date of the lot currently in use.
- Preservation and packing must be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against damage during shipment from source to destination.
- All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box.
- All routine deliveries will be made Monday through Friday, to exclude Federal Holidays.
- Reagents/materials must be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.
- The response due date for this Sources Sought Notice is 4:00 PM CST, December 8, 2022. All questions and comments regarding this announcement shall be submitted via e-mail to the below POCs: