QandAs.pdf

Pathogen RFQ Q&A’s

1. We would like to know if this is a brand new contract OR if there is (was) an incumbent performing these services.

A1. This is a recurring effort currently serviced by mul�ple award indefinite delivery indefinite quan�ty (IDIQ) contracts.

2. If not brand new, could you please provide the current / previous contract number?

A2. 123A9418D0016 – 3M

123A9418D0017 – Hygenia

123A9419D0001 - Biomerieux

3. Do offerors need to submit a price proposal and past performance by the Nov 27th deadline? Or do we submit a technical capability statement first, and only submit price and past performance if we are accepted into Phase II?

A3. Please submit price and past performance informa�on by the Nov 27th deadline.

4. In the PWS, Line 1 states "Uses an enriched sample and isolated colony as prescribed in MLG Chapters 4, 8, and 41" MLG Chapter 4 (as an example, when considering Salmonella) describes a primary enrichment on Day 1, and a differen�al/selec�ve media used for isola�on on Day 3. So it is not clear what you mean by "uses an enriched sample and isolated colony". Do you want a test kit that will detect the Salmonella a�er the primary enrichment stage, or do you want a kit that will confirm Salmonella a�er the isola�on step on Day 3 ?

A4. FSIS is interested in a solu�on that can both detect pathogens from an enriched sample (day

1) as well as iden�fy pathogen presence/absence in intermediary steps of the confirma�on process using the same technology/solu�on. For example, a poten�al solu�on might be a PCR kit that can be used to iden�fy presence/absence of a pathogen from enrichment on Day 1 as well as on a single, diluted colony Day 3.

5. My understanding of your RFQ is that your goal is a kit that will flag all Salmonella nega�ve samples as quickly as possible (so that food can be cer�fied as Salmonella nega�ve). Is that accurate ? If that is the case, would you be open to a kit that performs all of the MLG Ch 4 reac�ons in parallel, thereby speeding up the "confirmed nega�ve" diagnosis.

A5. FSIS needs a method that can quickly screen both nega�ve and posi�ve samples for Salmonella, Listeria and Campylobacter. Samples that screen nega�ve, do not move further into the confirma�on process. As a public health organiza�on, these data generated from both nega�ve samples and posi�ve isolates are used to accurately iden�fy and respond to outbreaks, conduct efficient traceback, and study the environmental harborage and movement of pathogens in regulated establishments.

6. The PWS line 20 refers to Serotyping of Salmonella. Does this require Serotyping via Whole Genome Sequencing, or would you be open to Serotyping via an�gens ?

A6. The Agency needs a rapid solu�on with the ability iden�fy the presence/absence of serotype(s) prior to having an isolated colony. Capabili�es of iden�fying serotype(s) from an enrichment are preferred.

7. Will there be a requirement to supply the evalua�ng FSIS labs with Salmonella serotyping kits and Listera species kits since they’re include “Background and Purpose” sec�on, but not the delivery schedule for the “Tes�ng Phase”?

A7. Yes, vendors should submit both Salmonella serotyping kits and Listeria species kits. The labs intend to evaluate solu�ons for all criteria listed to make an informed decision in the interest of public health.