Responses to LFI Strip RFP.pdf

Solicitation W911SR23R0005 Request for Proposal (RFP) and Product Demonstration Model (PDM) Questions and Responses

1. The Section B Item 0001 states 559,000 each and then defines First Article Production Lots in the verbiage below the qty. Is this the correct quantity of FA Production Lots? As stated in Section 2 Requirements, for a lot size ordered, that there will be 200 strips for conformance testing added to the lot size. Would it be appropriate to set the FAT Lots at 2500 strips for validation the MFR can make compliant strips for each analyte?

Response: The maximum quantity of FAT strips over the contract PoP was established as such to be in alignment with the operational LFI strip CLIN 0002. The Government’s intent is to allow for the maximum flexibility in issuing delivery orders and the total quantity referenced on CLIN 0001 represents the maximum ID/IQ value of that CLIN over the ID/IQ Period of Performance. It is not representative of the total amount or unit pricing.

2. As the government is aware, Industry standards typically require FAT for any change of major components in a configuration. For example, new lot of antibodies, either capture or detector; New strip manufacturer; New colloidal gold supplier; New membrane supplier. The change of antibodies lot numbers is significant. New Strip manufacturer also significant and industry standard would stipulate new FATs. Other components are typically customer designation.

Would USG consider defining FAT Lot size and putting 10 or 12 FAT lots as the number of Lots for this Item? Each contract year would not need that many, but would require a few lots per year.

Response: Offer can establish internal process on defining FAT lot size. See section L.13.1.6 Provide a written abstract that summarizes the following as part of the Offeror’s quality control that will be employed in LFI strip manufacturing as specified in the Government’s SOW: Inspection and Test Plan, Stability, Test Plan, First Article Test (FAT) Plan, Production Article Test Plan, First Article Testing, First Article Test and Inspection Report, Production Article Testing, and Certificate of Conformance.

3. Item 002 states 32,000,000 each strips. Assumption is that this is for entire PoP of the contract.

Will this section B be revised for each year of PoP for pricing or do we propose each year and then roll into this one year of pricing Item for entire contract PoP in Section B?

Response: Section B establishes the CLIN structure for only the base year. Reference L.15.4 Volume V

– COST/PRICE AND CONTRACT DOCUMENTATION for instructions on Cost/Pricing over the PoP of contract. The Government’s intent is to allow for the maximum flexibility in issuing delivery orders and the total quantity referenced on CLIN 0002 represents the maximum ID/IQ value of that CLIN over the ID/IQ period of performance. It is not representative of the total amount or unit pricing.

4. Will there be a section B CLIN for base and then option years to have pricing details populate the section B for each Year? Current Section B, only has one year.

Response: The ID/IQ will have a period of performance of five years after award. No option years are anticipated. Reference Section F of the Solicitation.

5. The pricing template in excel shows each year is to be priced. Will the template be tied to the Section B for submission?

Response: The Pricing Template will be used to establish unit prices for the items required under this

ID/IQ.

Please clarify procedural requirements so we can ensure compliance with the RFP intent.

6. The $1,000,000 minimum and $35,000,000 maximum amount is assumed to be the total contract PoP, not individual years. Please clarify this is the correct interpretation. The spreadsheet has contractor minimums, can the government provide the desired minimums for each year?

Response: That interpretation is correct. The Contractor is to propose a minimum order quantity required to support the proposed annual price for each type of strip required.

7. The quantity of strips and the dollar value of the maximum contract value may be mutually exclusive.

Is 32,000,000 strips the quantity to price? The price for the minimum would be different than price for listed amount, due to economy of scale.

Response: The Government’s intent is to allow for the maximum flexibility in issuing delivery orders and the total quantity referenced on CLIN 0002 represents the maximum ID/IQ value of that CLIN over the ID/IQ period of performance. It is not representative of the total amount of the contract or strip unit pricing.

8. Section 6 states travel will be priced at task order level. Will government provide a plug number for bidding purposes?

Response: Travel will be negotiated per Task Order and upon approval of Government. There is no bidding prior to award.

9. May we get a copy of the security guidance referenced in the RFP, Section 9.0 page 16, item 9.3?

Response: The Department of Defense Chemical, Biological, and Radiological Defense Research, Development and Acquisition Security Classification Guide, dated September 7, 2018, as well as any other applicable Security Classification Guides are available for download at the Defense Technical Information Center website (https://dtic.mil).

10. When will the materials for the PDM be shipped, and is the current RFP timeline still in effect?

Response: The materials are due to be shipped on Wednesday, May 17th and due to be delivered on Thursday, May 18th. The current timeline as stated in the solicitation remains the same.