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

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

1. 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. Is there a specific method for collecting the wastewater from the aircraft lavatory that is preferred? Is it acceptable for the wastewater to be obtained from the valve at the bottom of the vacuum truck (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7454825/) or will we need to obtain a sample trap (https://www.sciencedirect.com/science/article/pii/S0160412021005638) to collect the sample before entering the truck?

a. CDC Response: Offeror should collect the sample before it enters the truck through a sample trap to reduce cross-contamination of samples.

14. The number, frequency, and location(s) of airport terminal wastewater collections is not listed. Can you clarify this requirement?

a. CDC Response: Wastewater collections should occur at the 5 locations identified for collection. The offeror shall collect and process wastewater samples from aircraft lavatories for 50 flights per week yielding 2600 samples per year and shall conduct RT-PCR of all samples for SARS-CoV-2 and conduct genetic sequencing of all positive samples for variant detection using several possible methodologies including but not limited to targeted sequencing with amplification and shotgun sequencing (see 1.5.b). The five sample collection locations are the following US international airports: New York John F Kennedy, Newark International, San Francisco International, Hartsfield Jackson Atlanta, and Dulles Airport Washington DC.

15. Who will be the points of contact for designating which flights to sample for passengers and/or wastewater?

a. CDC Response: A CDC subject matter expert will be the point of contact. Contact information will be provided at the time of award.

16. What is the anticipated time gap between designation and collection?

a. CDC Response: Offerors should begin collecting samples from designated flights as soon as possible, but no later than 5 days after the CDC subject matter expert designates flights for collection at the existing 5 airports.

17. How will passengers be notified that they are eligible to participate in opt-in testing?

a. CDC Response: The offeror will recruit arriving international travelers (volunteers) in the airport; adults > 18 are eligible to participate.

18. Will an airline contact be provided by the CDC or need to be established by the contractor to offer passengers the opt-in testing for their flight?

a. CDC Response: Airline contacts must be established by the offeror.

19. Will an airport contact be provided by the CDC or need to be established by the contractor to ensure access to the tarmac for wastewater sampling?

a. CDC Response: Airport contacts must be established by the offeror.

20. If the contractor is not the designated wastewater collection provider for a designated flight, will the airport contact have the authority to permit access to the flight wastewater to collect the sample?

a. CDC Response: It is the offeror’s responsibility to work with airports and airlines to collect wastewater from designated flights. CDC will designate flights/locations for collection but will not otherwise coordinate offeror’s collection.

21. Task 1.5g states “Contractor shall enhance passenger sampling on flights where wastewater surveillance yields lineages and variants that need to be linked to traveler sampling”. As the results of wastewater testing will not be known prior to the window of opportunity to collect samples from passengers, can you clarify this requirement? To enhance sampling, will it be permissible incentivize passengers to participate for this task, or more generally, with gift cards or other small, low-cost items?

a. CDC Response: Offeror is responsible for recruiting additional participants for pooled and individual sampling from flights which are targeted for wastewater surveillance. The results of wastewater surveillance may direct which flights are targeted for future wastewater and pooled/ individual traveler sampling. Offeror is responsible for developing a recruitment strategy to enroll participants which can include incentives, gift cards, or other methods.

22. What is the timing for the bioinformatics piece of the RFP?

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. This includes use of bioinformaticians to determine lineages and inform analyses.

23. What is the threshold for a “surge” in cases? Do laboratories have to reserve sample volume availability to account for a surge, or will laboratories be given a ramp-up period to account for case surges?

a. CDC Response: Surge CLINs would be exercised at the discretion of CDC subject matter experts. Due to the dynamic nature of the COVID-19 pandemic, this is subject to change and cannot be predicted. If surge expansion is implemented, one or more optional CLINs would be exercised. Offeror must implement the increased surge no later than 7 days after receipt of contract modification or an Authorization to Proceed issued by the Contracting Officer.

24. Section 1.4.a – Is the contractor responsible for reporting results of all individual tests to participants, or only positive results?

a. CDC Response: The contractor is responsible for reporting all results (positive, negative, and indeterminate) of individual tests to the appropriate state or local health department using existing public health data reporting mechanisms (e.g., the Association of Public Health Laboratories Informatics Messaging Services, APHL AIMS, platform).

25. Section 1.5.g – What “enhanced passenger sampling” measures need to be taken if wastewater surveillance yields lineages/variants of concern?

a. CDC Response: The results of wastewater surveillance may direct which flights are targeted for future wastewater and pooled/ individual traveler sampling.

26. What is the reporting requirement for wastewater RT-PCR?

a. CDC Response: The offeror will report results to CDC.

27. Will the awardee be required to become a vendor to the airport, have a lease/etc. or will USG facilitate access to the arrival/baggage areas?

a. CDC Response: It is the Contractor’s responsibility to lease space from airports if required for access to the terminal. Access requirements can vary depending on the airport, and the contractor is responsible for researching and meeting these access requirements with the local badging and CBP offices at each airport.

28. Is direct reporting to HHS protect required?

a. CDC Response: No.

29. Is there a max of testing in the Firm Fixed Price, and USG would offset additional costs over and above that? (should price monthly program to cover some minimum level of testing + additional)

a. CDC Response: CLIN 0001 is firm fixed price for all services outlined in Task 1. CDC will not off-set additional costs or add additional funding to CLIN 0001.

30. How much notice is given for surge expansion to other airports, and what is the expected timeline for implementation?

a. CDC Response: If surge expansion is implemented, one or more optional CLINs would be exercised. Contractor must implement the increased surge no later than 7 days after receipt of contract modification or an Authorization to Proceed issued by the Contracting Officer.