Q&A_Hydro_18-R-0014.docx

Offeror’s Questions Hydrocodone & Hydromorphone Reagent Kits N62645-18-R-0014 Question 1:

DFARS 252.211-7003 is listed as being applicable on p.1. Is it applicable since the unit cost will be less than $5,000? If so, how is this information included in the price sheet?

Answer: DFARS 252.211-7003 is not applicable and will be annotated accordingly.

Question 2:

Section 4.4 on page 49. This section states “Offerors shall state the total number of tests per kit proposed for CLINs 0001, 1001, 2001, 3001, and 4001 in Attachment 1: Pricing Sheet. The number of tests shall be based on the reagent volume recommended by the equipment manufacturer”.

a. Equipment manufacturers develop and provide procedures only for their own brand of reagents.

b. Reagent manufacturers develop optimized, test-specific instrument parameters on each analyzer model, including the Beckman AU5800 specified in this solicitation. For proper performance, the “reagent” manufacturer’s recommended procedures should be provided and followed.

c. Amendment 2 of Oxycodone Solicitation N6264517Q0028 modified this sentence to specify “reagent volume recommended by the reagent manufacturer”.

Can the Hydrocodone Solicitation be modified to be consistent with statement used with the Oxycodone Solicitation “reagent volume recommended by the reagent manufacturer” in place of “equipment manufacturer” as it is currently stated?

Answer: The solicitation was amended to change section 4.4 from “equipment manufacturer” to “reagent manufacturer” under section 52.212-1 of the solicitation.

Question 3:

The following was added to Evaluation Factor B in Amendment 2 of Oxycodone Solicitation N6264517Q0028, but is not included in this solicitation:

“Note: DDRP intends to use the immunoassay kits in a manner consistent with their FDA approval. The package insert and information for the analyzer settings must contain the information necessary for DDRP to use the immunoassay kits consistent with the device’s FDA approval. This ensures DDRP can use the immunoassay kits properly and derive the full benefit of the FDA-approval.”

Can this statement be included in the Hydrocodone Solicitation?

Answer: The solicitation was amended to include the following language under section 52.212-2 of the solicitation.

“Note: DDRP intends to use the immunoassay kits in a manner consistent with their FDA approval. The package insert and information for the analyzer settings must contain the information necessary for DDRP to use the immunoassay kits consistent with the device’s FDA approval. This ensures DDRP can use the immunoassay kits properly and derive the full benefit of the FDA-approval.”