Question_and_Answer_18-R-0033.pdf

Solicitation #: 18-R-0033

25 April 25, 2018

Question and Answer for Solicitation N62645-18-R-0033

The purpose of this document is to answer questions requested by Hologic Diagnostic Solutions.

1) -Page 1, fourth paragraph states the Naval Hospital Jacksonville has a maintenance requirement for

Government-owned equipment. Is the intent of the Naval Hospital Jacksonville to procure the analyzer system (capital purchase) or will it consider a reagent rental option?

Answer) The intent is to lease the laboratory analyzer.

2) -Page 1 Statement of Work Preamble- Is the intent of the Naval Hospital Jacksonville to attain a singular analyzer capable of performing molecular tests such as HPV and papanicolaou (Pap) smears? To our knowledge there is currently no system in the market that performs both molecular testing and Pap smear processing. There are however systems that perform HPV testing off of Pap test samples.

Answer) No, not a singular analyzer, NH Jacksonville already has a processor for pap

Smear testing. The new analyzer is intended to be used for HPV testing.

3) - Page 1 Statement of Work Section 1 – Equipment a.) Is the intent of the Naval Hospital Jacksonville to attain an automated system capable of analyzing nucleic acids from The Thin Prep Pap test for HPV testing? No HPV vendor accepts any sample types other than liquid based pap tests.

Answer) NH Jacksonville is mandated to utilize the Thin-Prep medium for pap smears, which is liquid based and compatible with the analyzer we are trying to acquire.

4) -Page 1 –Statement of Work Section 1 – Equipment c.) Can you clarify what tests NH Jacksonville is looking to collect from the specimens listed? At this time, HPV can only be run by liquid based cytology specimens. The only FDA-approved medium for HPV testing is liquid based cytology.

Answer) Refer to question 3.

5) -Pages 3 & 4 – Statement of Work Section 6 – Equipment Uptime Rate and Calculation – Can you clarify if the uptime guarantee will be calculated by the Contractor or will it be calculated by NH Jacksonville?

Answer) NH Jacksonville will be expected to conducted the official uptime rate calculation.