Questions and Answers for 75D30124R72996.docx

Questions and Answers for 75D30124R72996 Technical Questions

1. Given the list of pathogens to evaluate, does CDC have a preference around IVD's regulated via FDA vs LDT's that are developed in house using registered reagents?

ANSWER: No the CDC does not have a preference. However, in an emergency CDC would like to see a test developed, validated and in use as quickly as possible and that may mean LDT vs 510k.

2. Is the award intended to support clinical trials and submissions for FDA 510k or de novo clearances?

ANSWER: The award is not intended to support submissions to FDA for 510K or De novo clearances.

3. Does CDC have any interest in blood based evaluations and antibody based testing for any of the pathogens or is the focus solely direct pathogen detection?

ANSWER: For Task C of the task order (Table 1 on page 52 of the revised solicitation), pathogen detection for active infection for the listed conditions conducted by the contractor is the main priority and minimum requirement for this contract, but all testing related to the conditions will be accepted.

4. Is CDC interested in awardee also supporting connecting positive patients to care as well as reporting back their results.

ANSWER: This topic is important, but out of scope for this contract and will not be included.

5. Is CDC interested in awardee supporting CDC from a data sciences and epidemiology perspective. In particular, many tests have population level characteristics that may vary with pathogen spread and reporoductive number (Rt). Can awards support the development of bioinformatics and data science around public health data that extends beyond reporting to health agencies – for example the development of tools that can support identification of speed of spread based on cross sectional evaluations of laboratory described pathogen loads, or identify current or future hot spots more accurately or seasonality, etc.

ANSWER: This topic is important, but out of scope for this contract and will not be included.

6. The assumption is to have all assays ready to go to drive the capacity needs as indicated. What is the process, timelines and the requirements for testing capacity in case of a new pathogen which is making an public health impact. Is there room for flexibility in case of an unknown entity?

ANSWER:. In case of a new pathogen, CDC will issue a Task Order that specifies the process, timelines, and any other requirements of testing capacity at that time. If CDC issues a Task Order for testing capacity or test development for a new pathogen, CDC will provide a timeline of when the test or testing is needed.

7. Is there flexibility to use an LDT for testing? Especially in case of a public health concern specially in case the algorithm that is used for screening and reflex testing is not established?

ANSWER: Yes, however this will require discussion between the contractor and CDC to ensure the LDT meets the diagnostic needs of the response. This discussion will take place after the proposal for the TO is received.

8. For Unique Patient Identifier

a. Samples are typically submitted to the laboratory as unique accessioning / specimen identifiers and rarely with a comprehensive identifier for the patient over time, especially if samples are received from multiple sources / providers.

i. Would the contract be responsible for “matching” patients utilizing submitted demographic information and, if so, is there a suggested matching criteria that CDC would prefer be utilized (First Name, Last Name, DOB, etc.)

ANSWER: Contractors will not be required to create a patient identifier if one is not available in the database currently. A lack of patient identifier will not disqualify a contractor.

9. Table 1. Covered conditions and pathogens: 1) The current list (when clicking the link) of available pathogens within RCKMS lists “cancer”. Is there a defined scope for “cancer” or is there a broad request for cancer data? 2) Will the CDC be providing a list of test codes (ex. LOINC) post award for the conditions and pathogens in Table 1?

ANSWER 9 (1): Cancer testing will not be included in the first iteration of requested data. CDC will provide additional information when or if it is required.

ANSWER 9(2): Yes, CDC will provide a list of test codes post-award. This list will focus on infectious disease conditions from RCKMS and additional conditions called out in Table 1.

10. Scope of Work Task Area C – Data. Is there a preferred data delivery method?

ANSWER: The preferred data delivery method was included in the original solicitation under HL7 2.51 (HL7 Message Mapping Guides and Standards | CDC). This is the preferred data standard that contractors are encouraged to follow. Please see section 3b in Work Task Area C, pages 23 and 24 for further information.

11. The RFP states: “If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) must work with the agency and supply the deliverables required to complete the ATO prior to any use of the system in a production capacity, i.e., its intended users able to collect, store, process or transmit data to fulfill the system’s function.” Is the correct interpretation of this that a vendor can apply without an accepted ATO and that they can work toward that ATO so that it is in place before the system is activated for use in a real-world testing scenario? Can the activities to get an ATO be budgeted for in the application?

ANSWER: Yes, that is the correct interpretation. The CDC will receive data from a company and house it on CDC systems.

12. For Task Order 001, is there a minimum number of tests from Table 1 or linked tables that a vendor should be able to offer?

ANSWER: No, there is no minimum number of tests.

13. For Task Order 002, can the activities to achieve FDA Part 820 compliance be budgeted for in the proposal? Is there a timeframe by which the laboratory needs to achieve this compliance?

ANSWER: Respondents to this RFP should already have an established quality management system. This has been added on page 90 in section 4.1 under Task 4.

14. For Task Area B – Specimen Collection, could the CDC provide a list of all acceptable sample types and/or sources (clinical, agricultural, environmental, etc.)?

ANSWER: CDC cannot provide a list of all acceptable sample types and/or sources. The acceptable specimen types will be dependent on the outbreak/emergency and in which parts of the body the pathogen can be detected.

15. Is the expectation that samples will come from a variety of customer types? Would the contracting awarded entity be required to negotiate / contract with each customer directly to run samples or will the CDC be routing all samples through this contract vehicle?

ANSWER: Yes. The expectation is that the samples will come from a variety of customer types. CDC will collaborate with awardee to identify sample sources or provide access to material if available at CDC after award for a specific TO is made.

16. Can the CDC confirm if there is a target per-sample test cost, and would this cost be separate from the ongoing capacity upkeep costs?

ANSWER: There is no target per-sample test cost. This is a contractor’s business decision and cannot be set by the CDC.

17. Can you confirm that the Specimen Collection capabilities described under Task Area B (on pg22) falls under Task Order 001?

ANSWER: Yes, this is found under Task Order 0001 as Optional Task 4 on pages 55 and 56. This falls under Task Area B of the basic IDIQ contract. While it is an optional task, this must be priced for evaluation purposes. It may or may not be funded at the time of award.

18. Transmission of data to “other possible contractors…” Please detail and explain the possible contractors (name, business type, etc.) to which awarded supplier is expected to provide this data.

ANSWER: Data will be shared with approved CDC vendors hosting CDC databases for CDC analyses for the purposes of storing and securing data. Any analytics conducted by other possible contractors will be in aggregate across vendors, and in support of CDC or public health activities. The contractor will not be responsible for direct transmission to the other vendors.

Contractual Questions

19. Would the CDC allow a proposal response extension to August 2nd? We are working diligently to complete the response to the RFP, however, due to the detailed scope of the requirements, and because of conflicting schedules of key personnel who are preparing our response, we respectfully request an extension until Friday, August 2nd.

ANSWER: There will be an extension due to the addition of the second task order until July 30. Due to tight timeframes and the need to award this fiscal year, we’re going to have to maintain a July 30, 2024 cutoff date.

20. Does Exhibit 1 & 2 – Contractor Non-Disclosure Agreement need to be executed and submitted with the RFP Proposal?

ANSWER: No, this is required after award prior to work starting.

21. The Proposal Instructions state that Volumes I and II should not contain any pricing information. The instructions also state that Attachment 5 should be included with Volume I Technical Capability under Subfactor 3. Attachment 5 is asking for pricing information. Can you please clarify these instructions.

ANSWER: This has been corrected in amendment 0001. Attachment 5 – Fully Burdened Hourly Labor Rates has been changed to Attachment 6 – Fully Burdened Hourly Labor Rates (page 124) and is now required to be submitted as part of Volume IV – Pricing. Previous Attachment 4 – Labor Categories, Descriptions/Duties, and Qualifications/Education, now Attachment 5 – Labor Categories, Descriptions/Duties, and Qualifications/Education (page 123) shall not contain any pricing and shall be submitted in Volume I. Offeror shall include ALL labor categories that it identifies as necessary to perform the full range of tasks included in the basic contract, and identify the specific task area(s) (e.g. crosswalk) applicable to the labor category.

22. Volume IV: Factor 4 Price Proposal “The pricing proposal shall consist of a completed Schedule B for all five years….” Will the CDC please clarify where Schedule B is located? Is Schedule B the Item IV. Pricing tables for Base Work, Option Task 1, and Option Task 2?

ANSWER: On page 191, Volume IV: Factor 4 – Price Proposal, Schedule B was a typo. It has now been corrected to read, “Offerors shall submit a completed Section B (pages 57 - 67) for Task Order 0001. Offerors shall submit a completed Section B (page 93) for Task Order 0002. Offerors shall submit a completed Attachment 6 for the full five years of the IDIQ (page 124). See additional information regarding detailed cost and pricing data below. The total value of the two task orders will be compared between all offerors.”

23. Attachment 1/IDIQ Statement of Work provides descriptions of Task Areas A, B and C and an optional Task 5. Task 4 is referred to on pages 26 and 27, but there is no other narrative description of Task 4 in the 155 page document (as confirmed by automated search of the document). Please confirm that there is no expectation for a response to “Task 4”.

ANSWER: Page 26 has been changed to read Task Area D Optional Task… There is no task 4.

24. The instructions for preparation of proposals is outlined on pages 147-151. Please confirm understanding of the elements to be responded to in Volume I: Technical Capability:

a. Subfactor 1 will be a response to Attachment 1/IDIQ Statement of Work.

b. Subfactor 2 will be a response to Attachment 1/IDIQ Statement of Work.

c. Subfactor 3 will be a response to Attachment 2 – First Task Order Statement of Work.

ANSWER: This was revised on page 187 and see below:

Technical/Management

1. Scientific and Technical Capability

2. Staffing and Management Plan

3. First Task Order

4. Second Task Order

Price (shall include Schedule B and First Task Order Price)

IV

1 Electronic Copy None; provide pricing in the format provided in Attachments 6 and 7 and in Task Orders 0001 & 0002

25. Can proposing vendors include exhibits and/or an appendix? And would the exhibits and/or appendix count towards the 17-page max for the Volume I Technical Capability?

ANSWER: Yes, offerors can include exhibits and/or an appendix. These will count toward the overall 17-page limitation.

26. ATTACHMENT 1, IDIQ STATEMENT OF WORK contains Task Areas A, B and C and then skips to an optional Task 5. ATTACHMENT 2 – FIRST TASK ORDER STATEMENT OF WORK references Base Work Item 0001, which references a section 1.3 of the Task Order SOW (this appears to cover Task Areas A-C). It also has 2 Optional Tasks, with the second stating that it refers to optional Task 5. Can you please clarify these references and the base and optional tasks.

ANSWER: Pages 26 and 54 have been modified to remove Task 5 and add Task Area D – Optional Task. The pricing boxes starting on page 57 have been modified to remove 1.3 and add Section C of the Task Order SOW and reference back to the basic IDIQ SOW. The optional task mentioned on pages 26 and 54 (Annual Data Submission – Drug Tests) is optional in that the offeror doesn’t have to have the ability to do it to win a contract but it is something the CDC would like to have. If an offeror can, then the CDC would require the pricing and then may elect to pay for those services in the first task order. If the offeror cannot provide this, then a statement stating as such is sufficient. The other optional tasks in the first task order are optional in that the CDC may elect to fund them during the period of performance of the task order or may not and they are required to be provided by the offeror in order to win a contract.

27. Attachment 5 – Labor Categories, Descriptions/Duties, and Qualifications/Education.

a. Please clarify what information the CDC is looking for in Attachment 5. The instructions on Attachment 5 refer vendors to list labor categories based on “Section C” however, Section C is the Contract Clause section.

b. Please clarify if the labor categories are specific to the development of Influenza A H5 in Task Order 0002?

ANSWER: Attachment 5 – Labor Categories, Descriptions/Duties, and Qualifications/Education, page 123 – shall not provide any pricing. Offeror shall include ALL labor categories that it identifies as necessary to perform the full range of tasks included in the basic contract, and identify the specific task area(s) (e.g. crosswalk) applicable to the labor category. Section C has been changed to Section D and Performance Work Statement has been changed to Statement of Work.

28. Attachment 6 Fully Burdened Hourly Labor Rates. Please clarify Attachment 6 requirements.

a. p. 114 Amended version – Attachment 6 states ALL task orders

b. Price Proposal instructions state Attachment 6 shall be submitted for “Task Order 0002 and included in this volume (IV)” ANSWER: Attachment 6 – Fully Burdened Hourly Labor Rates, page 124, is a required submission in Volume IV. For Task Order 0002, the labor categories shall be filled out along with the first 12 months column. For the IDIQ pricing, the labor category column and pricing in all the remaining columns shall be filled out providing hourly rates for the labor categories for the entirety of the contract ordering period. These categories and prices will be used across the five-year ordering period and will be the only rates and categories that are used for test development activities.

29. What Volume of the response should Attachment 5 be included in?

ANSWER: Attachment 5 - labor categories, descriptions/duties, and qualifications/EDUCATION should be included in Volume I.

30. Attachment 7 – IDIQ Price Schedule

a. Can the CDC please define “Quantity” and “Unit” in the table?

ANSWER: Attachment 7 has been removed. Pricing from Task Order 0001 will be used to establish the five-year fixed price amounts and pricing from Attachment 6 – Fully Burdened Hourly Labor Rates will be used for the time and material labor rates.

31. Volume IV Factor 4 Price Proposal instructions, “a detailed pricing sheet for the first task order.”

a. Is this instruction referring to the pricing tables included in the SOW (“Warm Base” and “Optional Task 1”),

b. Can the proposing vendor submit their own detailed pricing sheet for task 0001?

c. Should the detailed pricing sheet for the first task order be included in the totals for Attachment 7?

ANSWER: Volume IV Factor 4, page 191 has been modified to read, “Offerors shall submit the following:

· Completed Section B (pages 57 – 67) for Task Order 0001.

· Completed Section B (page 93) for Task Order 0002.

· Completed first and second column of Attachment 6 – Fully Burdened Hourly Labor Rates (page 121) for Task Order 0002.

· Fully completed Attachment 6 – Fully Burdened Hourly Labor Rates for the IDIQ.”

Offerors shall provide pricing as outlined in the solicitation and not in their own format.

32. The RFP states “The associated North American Industrial Classification System (NAICS) code for this procurement is 621511 – Laboratory Testing with a Standard Size of $41.5M.” Would an entity with an NAICS Code of 541714 (Research and Development in Biotechnology (except Nanobiotechnology)) be eligible for this contract? Would an entity with an NAICS Code of 62151 (Medical and Diagnostic Laboratories) be eligible for this contract?

ANSWER: Yes, they would be eligible.

33. Does the aggregate maximum value of $118M for “all contracts cumulatively” refer to $118M potentially split among all suppliers, or $118M potentially awarded to each supplier?

ANSWER: Yes, the aggregate maximum value of $118M is a cumulative ceiling across all contracts awarded. There is no per offeror/supplier contract ceiling, and $118M refers to the entire programmatic ceiling.

34. What is section 1.3 of the Task Order SOW? The referenced section (1.3) is not clear. Please note page number, etc.

ANSWER: This has been revised to read Section C in the pricing boxes starting on page 57.

35. Does The CDC have an expected or maximum number of suppliers expected for award?

ANSWER: There is no set maximum at this point. The CDC is expecting to award more than one but will reserve judgment until an evaluation has been completed on all proposals received.

36. Please further define Attachment 7 Price Schedule:

a. What do the asterisks mean?

b. What information is expected in the quantity vs. units in this Attachment?

c. Are the designations regarding two weeks, etc., correct?

d. How do we get reimbursed for any tests performed after two months?

ANSWER: Attachment 7 has been removed. The CDC anticipates that testing can be established within a two-week timeframe to support emergencies, understanding there may be challenges and delays. After two months, the CDC is confident that insurance reimbursement codes will be available. If that is not the case, a new task order can be written to continue testing at the pre-approved contract rates.