Questions and Answers_RFP 75D301-22-R-72357.docx

Questions and Answers; RFP 75D301-22-R-72357 SARS-CoV-2 Genomic Surveillance Program

1. There appears to be an inconsistency regarding the due date of proposals between the SAM.GOV RFP landing page and the solicitation document. The solicitation document states "All proposals must be received NLT 9:00 AM EST on July 14th, 2022". The SAM.GOV RFP landing page displays a due date of "June 17th, 2022 09:00AM EDT". Can you please confirm the due date and time of proposals for RFP No. 75D301-22-R-72367.

Due date is July 14, 2022 at 9:00 A.M. EST.

2. There appears to be an inconsistency regarding the business requirements between the SAM.GOV RFP landing page and the solicitation document. The solicitation document states "This procurement has been designated a Full & Open completed under NAICS 541380 - Testing Laboratories". The SAM.GOV RFP landing page states "This acquisition is FULL & OPEN under North American Industry Classification System (NAICS) 541380 - Testing Laboratories with small business size standard 16.5M". Can you please confirm if RFP No. 75D301-22-R-72367 is set-aside for small businesses only.

This is full & open and is NOT a small business set-aside.

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5. How should Item 0001 be priced - price per test, a flat rate for 1 year of services at all 5 airports, etc.? The Scope described in Section 4 Task 1 includes onsite operations, RT-PCR testing, whole genome sequencing and wastewater collection and testing - should all these services be lumped into a single pricing structure? (Reference: Section B - Supplies or Services and Prices/Costs)

a. CDC Response: CLIN 0001 is firm fixed price for all services outlined in Task 1. Task 1 includes “The contractor will collect a minimum of 483,000 samples per year and 35,000 pools per year.” For reference: 483,000 samples = 420,000 samples in pool tests (assuming 12 samples per each of the 35000 pools) in addition to 63,000 double collected samples for individuals in pools (assuming ~15% of pools selected for individual testing, for Task 1).

6. In Section C Section 4, point 1.1.e, it is described that “The contractor will collect a minimum of 483,000 samples per year and 35,000 pools per year.”

Is there a maximum volume for Item 0001, after which Item 0002 for surge testing is triggered? (Reference: Section B - Supplies or Services and Prices/Costs)

a. CDC Response: No; CLIN 0001 requirements are minimums. CDC’s decision to potentially exercise CLIN 0002 is not related to the testing amount in CLIN 0001.

7. Do the volumes for "individual samples" include the follow-up individual sample testing from a positive pool? (Reference: Section B - Supplies or Services and Prices/Costs)

a. CDC Response: Yes, follow-up individual sample testing will count toward the total sample volume of 483,000.

8. Section C Section 2 mentions that testing is voluntary. How will individuals be chosen for or routed to testing? How will certain flights/regions be prioritized for testing? If this is voluntary testing, how will the minimum volumes described in Section C Section 4, point 1.1.e be met? (Reference: SECTION C SECTION 2 – PURPOSE)

a. CDC Response: Offeror is responsible for developing a recruitment strategy to enroll participants and meet minimum testing requirements. Flights will be prioritized based on consultation with CDC Subject Matter Experts.

9. Task 1.1.b. - will CDC assist the contractor in securing space at each airport? Will the contractor need to pay for the space? (Reference: SECTION C SECTION 4 - TASKS TO BE PERFORMED)

a. CDC Response: No; offeror must identify and secure necessary space requirements to perform tasks outlined in the solicitation. Offeror is responsible for any fees associated with use of space at the airport.

10. Task 1.1.e - it is described that “The contractor will collect a minimum of 483,000 samples per year and 35,000 pools per year.”

Is this a volume guarantee or does the contractor need to market and advertise to reach this volume? (Reference: SECTION C SECTION 4 - TASKS TO BE PERFORMED)

a. CDC Response: Offeror must reach the required minimum volume and is responsible for any marketing and advertising necessary to reach this volume.

11. Task 1.3.c - “The contractor shall also notify the relevant health departments about pooled test results when indicated by and in collaboration with CDC, using CDC’s Epidemic Information Exchange (Epi-X) secure, web-based network.”

Does the contractor need to submit positive pool information to the Epi-X secure network, and then also submit the positive sample(s) (once identified) from that pool to the relevant State Health Department? (Reference: SECTION C SECTION 4 - TASKS TO BE PERFORMED)

a. CDC Response: Duplicate notification is not required. Epi-X provides notification to the relevant State Health Department.

12. Task 1.4.c - “Contractor shall ensure a turnaround time for the entire process of approximately 6-10 days. Contractor shall ensure expedited turnaround using faster techniques (e.g. Oxford Nanopore) as determined in conjunction with CDC when necessary” Is this 6-10 day TAT inclusive of both PCR (and follow-up PCR, if pooled) and genetic sequencing? Or is this the TAT for just genetic sequencing, as suggested in Task 1.4.b “Contractor shall report sequencing results within 6-8 days after initial PCR report, but no later than 11 days after PCR result is reported.”?? (Reference: SECTION C SECTION 4 - TASKS TO BE PERFORMED)

a. CDC Response: The turnaround time is inclusive of both PCR results and sequencing; both steps should be completed within 6-8 days and no longer than 11 days.

13. Task 1.4.d - “Contractor shall implement a multi-modal approach to testing with the ability to identify and use an appropriate test at any given time depending upon the expediency necessary and the circulating variant.”

Are you able to elaborate on this? Does this mean multiple testing modalities at the airport, i.e. offering both RT-PCR and antigen tests, or does this refer to alternating between individual and pooled testing, or does this refer to different sample types (nasal, saliva, etc)? (Reference: SECTION C SECTION 4 - TASKS TO BE PERFORMED)

a. CDC Response: Multiple PCR testing modalities are acceptable. The contractor will ensure that samples are processed, stored, and tested appropriately using testing modalities including SARS-CoV-2 RT-PCR and whole genome sequencing of positive samples for lineage determination.

14. Task 1.5.f - “Contractor shall secure contractual agreements with airports and aircraft operators to obtain wastewater sample collection in airport and aircraft facilities” Will CDC put Contractor in contact with the relevant airlines/airports to negotiate these contracts, or will Contractor need to independently secure these agreements? (Reference: SECTION C SECTION 4 - TASKS TO BE PERFORMED)

a. CDC Response: Offeror shall independently obtain all necessary agreements with airport authority or aircraft operators.

15. Task 1.5.g - “Contractor shall enhance passenger sampling on flights where wastewater surveillance yields lineages and variants that need to be linked to traveler sampling.”

How will testing be enhanced if testing is voluntary, as described in Section C Section 2? (Reference: SECTION C SECTION 4 - TASKS TO BE PERFORMED)

a. CDC Response: Offeror is responsible for recruiting additional participants for pooled and individual sampling from flights which are targeted for wastewater surveillance.

16. Optional Task 2: Surge Testing: “Collection and processing of 25% of individual samples from travelers in positive pools as directed by CDC” Do all samples need to be pooled, or only some? What is the criteria to determine if samples should be pooled? How is this different from Task 1 in terms of the method for pooling? (Reference: SECTION C SECTION 4 - TASKS TO BE PERFORMED)

a. CDC Response: During both baseline and surge, all specimens will be pooled however offeror is responsible for collection of two swabs from each individual participant, pooling one and preserving the second. A portion of the second swabs will be individually tested in consultation with CDC subject matter experts. Methods for pooling should be the same for both Task 1 and Task 2, see Task 1 1.2.g.