Questions and Answers 1.pdf

Questions and Answers #1

Wastewater Testing

75D30123R72755

1. CLINs X002 and X003 are part of the BASE period (considering your costing sheet); however, these are not part of the BASE in the solicitation document. Could you please clarify?

• Pricing schedule attachment and CLINs have been updated on the solicitation.

2. The SOW states: "the base period is divided into four phases", then it only lists 3 phases, please provide the

4th phase or clarify

• There are only 3 phases. This error has been corrected in the SOW.

3. The volume 3 instructions to offerors does not reference a Past Performance Questionnaire. The evaluation section references Attachment J2 - Past Performance Questionnaire being a component of the past performance evaluation. The SAM.gov page does not include an attachment J2. Can the Government clarify if Past Performance Questionnaires are required, and if so, please provide Attachment J2 to offerors?

• Past performance questionnaires are not required. Solicitation has been updated.

4. Please provide the evaluation weighting associated with each evaluation factor (Technical Approach, Price, Past Performance)

• Page 39 of the solicitation states “technical and past performance are more important than price”

5. Please provide the evaluation weighting associated with each evaluation subfactor within the Technical

Approach

• The relative order of importance is stated on page 40.

6. Please clarify whether a past performance reference must meet all 4 of the bullets listed in paragraph 3 or if any reference meeting any of bullets 1, 2, or 3 and confirming to bullet 4 is considered relevant and acceptable

• All four criteria are required to be considered relevant to the scope of this solicitation.

7. Are other types of targeted sequencing approaches acceptable for other pathogens? For example, hybridization-based enrichment probes?

• Other types of targeted sequencing approaches are acceptable, however more sensitive methods will receive a more favorable evaluation. Hybrid capture has been shown to be generally less sensitive than targeted amplicon-based approaches and are suitable for small subset of samples where the target pathogen concentration is near the high-end point for wastewater samples.

8. We respectfully request that bullet 3, reading "Previous experience providing sampling supplies to wastewater treatment facilities and receiving raw wastewater samples for testing" be changed to "

Previous experience providing sampling supplies for collecting and receiving raw wastewater samples from site which may include wastewater treatment facilities and other environments where raw wastewater samples may be collected."

Rationale for change: Vendors with experience collecting and shipping raw samples from other types of locations than wastewater treatment plants can demonstrate equivalent ability to manage equivalently complex logistics operations. This experience should also be considered relevant for the purpose of past performance evaluation.

• Concur with recommended change. This bullet on page 43 of the solicitation has been updated.

9. For CLINs 0002 Please confirm that all vendors MUST sequence 400 samples per week for the purposes of equal and fair price evaluation.

• Sequencing will only be conducted on samples with sufficient SARS-CoV-2 signal to produce valid sequence data. Thus, it is not possible to pre-determine the number of samples that will be sequenced. The maximum number of samples for sequencing is 100-

400 samples per week (1 per site) depending on the contract year. Vendors should price for the max number of samples per week based on the number of sites in the respective contract years.

10. Please confirm vendors should assume 4 weeks per month for the purposes of pricing evaluation

• Yes, vendors should assume four weeks per month.

11. For CLIN X002, please confirm that all vendors should assume that all sites will require 1 sample per week to be sequenced, for the purposes of fair and equal evaluation

• Yes, vendors should assume all sites will require 1 sample per week.

12. For CLIN X005, please confirm that all vendors should assume that each site will require 1 sample per week to be sequenced, for the purpose and fair and equal evaluation

• Yes, vendors should assume all sites will require 1 sample per week.

13. For CLIN X004, please confirm that all vendors should assume twice weekly sample collection and testing, for the purpose of fair and equal price evaluation

• Yes, vendors should assume all sites will require 2 sample per week.

14. Should CLINs X002 and CLINs X003 also be blanked out for the Base Year, since CLINs 0002 and 0003 include 400 total sites for the envisioned base year work?

• Please see revised pricing schedule in Amendment 00002

15. Are past performance references where raw wastewater samples collected upstream of the wastewater treatment facility considered relevant?

• Yes, collection of samples at sites other than wastewater treatment facilities will be considered relevant past performance for this solicitation.

16. Would NWSS consider extending the due date out one week, from 18 August to 25 August 2023

• The due date has been extended to 25 August 23

17. Does the scope only include reporting on data, or will it also include the analysis of data?

• The scope of this solicitation does not include data analysis.

18. Does the CDC contract include a limit of liability? If not, may one be incorporated to align with the associated project fees?

• Limit of liability is not included.

19. Will there be an incentive for wastewater treatment plant operators? If so, will the supplier be expected to administer it?

• No incentives will be provided for wastewater treatment plant operators.

20. Will the CDC be using this contract to procure additional analytical support for the wider NWSS program?

• Data analysis is outside the scope of this requirement.

21. Can we provide multiple submissions? We are happy to provide any or all requested tasks.

• No, only one submission will be evaluated.

22. Considering development activities are not funded through this mechanism, what types of collaborations will be available to implement the additional pathogen services? Will the CDC help to identify the commercially available tiled amplicon offering for target pathogens?

• Should CDC exercise optional tasks 5 or 6 there will be significant communication with the awarded vendor prior to implementation. This communication will include discussion with CDC subject matter experts about assay selection, development, and validation, as needed.

23. May we provide NGS price points depending on throughput? We want to provide the most economical options, but NGS cost-of-goods drastically vary depending on the sample load.

• No, but please see revised pricing schedule and CLINs in Amendment 00002. Optional quantities have been significantly reduced.

24. What percentage of sites are being sequenced under the current contract?

• All sites are eligible for sequencing, however, only samples with sufficient SARS-CoV-2 signal are sequenced. The percentage of samples meeting this criteria varies as the incidence of COVID changes. The number of sites with samples meeting the sequencing criteria has varied from near 100% to 30% of sites on any given week.

25. Can the NGS be outsourced or ideally, should it be done in-house?

• Sequencing can be outsourced, but the contracted vendor will be responsible for ensuring that the required turn around time is met.

26. What is the minimum number of gene copies to sequence that the CDC requires to consider the result

“representative”?

• A more reliable metric for sequencing representativeness to use is breadth and depth of coverage. Although, there is no minimum coverage required as a wastewater sample may not have SARS-CoV-2 present, it has been suggested that a minimum of 60% genome breadth of coverage at a depth of 10X or greater relative to the reference genome be used when trying to infer the relative abundance of SARS-CoV-2 variants in a wastewater sample.

• Generally, samples with a SARS-CoV-2 Ct of 35 or lower will produce representative sequence, however, this threshold can vary depending on the methods used for processing, testing and sequencing.

27. Is there a preference for influent vs solids? Further, are Ceres Nanotrap particles the preferred concentration method? To our knowledge, previous contractors used this method, but we noted particle-based concentration was not listed under ‘Sample concentration’ at the following website:

https://www.cdc.gov/nwss/testing.html

• Both sample influent and solids are an acceptable sample matrix as long as the collection methods do not limit the participation of wastewater treatment facilities. Ceres Nanotrap particles are an acceptable concentration method and there isn’t a preferred concentration method.

28. Would the expectation be that samples still require a 36 hour TAT even through holiday periods?

• Yes https://www.cdc.gov/nwss/testing.html

29. Will the maximum number of tests per year be 41,600 (400 sites x 2/week x 52 weeks/year) including surge capacity? Or will surge capacity require more than 41,600 tests per year?

• Surge capacity would require additional tests. However, CDC does not anticipate a need for surge capacity. Offerors should respond based on the stated number of sites per year.

30. Will all enrolled sites be tested for the same pathogens, or will a subset of sites be tested for some of the pathogens versus others?

• Yes, all sites will be tested for the same pathogens.

31. Does NWSS intend to continue Mpox testing? The pricing schedule asks for 6 months of PCR Mpox testing for the base year (CLIN 0003, Row 10), but Options Years 1-4 ask for annual pricing for PCR

Mpox testing (CLIN X003, Row 13).

• Currently, CDC intends to continue mpox testing through February 2024 (6 months). If the outbreak is still ongoing at that time, CDC may opt to extend testing. Mpox is included as an annual cost in the option years to determine the maximum cost of the contract. Optional CLIN 0006 has been modified to represent the last six months of mpox testing in the base year in the event mpox testing is required past the first six month period.

32. Can we submit multiple pricing schedules and/or add rows to the pricing schedule?

• No, offerors must only submit one pricing schedule and cannot add additional pricing to the schedule. Please see revised pricing schedule in Amendment 00002.

33. Is there a preference for digital PCR versus quantitative PCR?

• Digital PCR is the preferred quantitative method.

34. Is there a target limit of detection (expressed as copies/liter and/or copies/gram) for the PCR assay?

• There is not a target LoD for the assay. However, more sensitive methods will receive a more favorable evaluation.

35. Is there a preference for influent or solids as the wastewater sample matrix for this contract?

• Both sample influent and solids are an acceptable sample matrix as long as the collection methods do not limit the participation of wastewater treatment facilities.

36. Will more sensitive testing methods (lower LoD) relative to less sensitive testing methods

(higher LoD) be given preference in the evaluation of proposals?

• There is not a target LoD for the assay. However, more sensitive methods will receive a more favorable evaluation.

37. Will all sites/facilities have the capacity to collect and ship samples on their own if given instructions by the contractor?

• Yes

38. How many of the 400 sites are currently sampling with the existing NWSS program?

• There are currently 370 sites enrolled in the NWSS contract. While these sites will be given preference for enrollment in the new contract, it should not be assumed that they will all transfer to the new contract.

39. Will the contractor be responsible for executing MTAs with individual sites or will the MTA be executed between the site and CDC or STLT health departments with the contractor named as a party?

• The contractor will be responsible for executing MTAs.

40. What is the total budget for the program?

• The Government estimate cannot be disclosed.

41. Clarify which CDC shipping guidelines apply to this RFP and if multiple, which apply and to what analytes do they apply.

• Wastewater samples for SARS-CoV-2 testing must be shipped as category B samples per

DOT and IATA guidelines.

42. Is Mpox reported with the same NWSS/DCIPHER file that is reported for Sars-CoV2 or is it SA Grams?

• Mpox is reported to NWSS in the same file as SARS-CoV-2.

43. Does CDC intend, in year 2 and beyond, to require the miniumum number of sites sampled to be 100? If the CDC choses to issue tasks 1 & 2, the additional volume of samples will not exceed 400, please confirm?

• Please see the revised requirement in Amendment 00002.

44. Will CDC count a proposal cover page, cover letter and table of contents in the page count?

• Yes, the proposal cover page, cover letter, and table of contents count toward the page count.