Questions and Answers - 75D301-21-R-71814.pdf

Questions and Answers

RFQ 75D301-21-R-71814

Tuberculosis Epidemiologic Studies Consortium (TBESC) III Support Services

Question # RFQ Reference (if provided) Question 1 No reference given

Question: Could you provide approximate ranges for the core funding awards (base period and all option periods) and the consortium projects/studies? I did not see this information in the announcement.

Answer: The Period of Performance can be found in Section B.

The Period of Performance is anticipated to be:

Base Period: 9/29/2021 – 3/28/2023 Option Period 1: 3/29/2023 – 3/28/2024 Option Period 2: 3/29/2024 – 3/28/2025 Option Period 3: 3/29/2025 – 3/28/2026

2 No reference given

Question: We would appreciate it if CDC would clarify when the intervention/implementation would occur. Would this be during the base period or at the beginning of option period 1?

Answer: Initial implementation is expected to begin after the first 12 months of the base period – i.e. at the beginning of the 13th month of the 18-month base period. The RFP will be amended to clarify this.

3 No reference given

Question: We would appreciate it if CDC would clarify who has to submit a biosketch/brief CV. Is this requested on key personnel only?

Answer: Yes; bio sketches/CVs are only required for key personnel.

4 No reference given

Question: The RFP states that investigator resumes are limited to two pages each. Is there a standardized format that is required for those resumes?

Answer: No; there is no prescribed format.

5 No reference given

Question: We request that the due date be changed from July 5th which is a Federal Holiday. Given the scope of the solicitation, the application will require coordination with multiple individuals, some of whom are still redeployed to COVID activities. Also, there will be less than 2 weeks from the time we get responses to questions until the application is due based on the current timeline. We respectfully request that the due date be pushed back until at least July 16th to allow adequate time to submit a thorough and complete application.

Answer: The proposal submission due date will be extended to 7/9/2021.

6 No reference given Question: The RFP requires quite a bit of detailed information be provided. However, the turn-around time for submission is only about 1 month. We would appreciate it if CDC would consider extending the submission deadline given the requirements of what materials need to be submitted in both the technical and budget sections. Some of the items requested by CDC will take additional time to collect and therefore it would be appreciated it the deadline for submission would be extended.

Answer: The proposal submission due date will be extended to 7/9/2021. CDC is not able to extend the due date any further out than that.

7 Page 9 Question: What data elements are required and being requested by CDC? In particular, what data will be required to extract from the Electronic Medical Record (EMR)?

Answer: This information is listed on Page 14 of the solicitation in Task 4.1.3(b).

Required data elements include those that are used to help build/populate an LTBI care cascade and track the following measures at minimum.

• Number of patients meeting screening criteria as defined by study protocol

• Number of patients tested by TB diagnostic test type and brand (e.g., QuantiFERON or T-Spot.TB)

• Number of results by test outcome

• Number of patients with chest radiographs performed

• Chest radiograph results

• Number of TB/LTBI diagnoses based on ICD-10 code

• Number of unique patients offered treatment by treatment regimen

• Number of unique patients starting treatment by treatment regimen

• Number of unique patients completing treatment by treatment regimen

8 No reference given Question: What type of EMR modifications is CDC requesting?

The costs of the modifications depend in part on the type of modifications requested. Can the costs of these modifications be included in the budget? Having more details on the modifications required will help with producing accurate budget costs for this component. Also, will the modifications be driven by a common protocol across all sites or rather due to customizations and plans at the local site level?

Answer: CDC is asking the offeror to propose and test interventions that they hypothesize will help improve the LTBI care cascade at the local level in a primary care setting. If an offeror is proposing EMR modifications as part of an intervention, it is acceptable to build related costs into the proposed budget.

9 No reference given

Question: The RFP requests that a letter of commitment be provided by the healthcare institution that will “implement policies and procedures to comply with study protocols;

modify EMR system; collect and provide required data; and conduct screening, testing, and treatment for LTBI”. Can CDC clarify what the healthcare institutions is committing to? In particular is there a study protocol that can be shared with the health care institution? How should the EMR be modified? Has that been pre-determined or will that be customized at the local level? This information is important in order to obtain commitments.

Answer: Offeror’s partners (if applicable) should express commitment to working with offeror and willingness to modify EMR (if applicable) and extract data. The exact interventions and EMR customizations (if applicable) will be decided by the offeror working with the healthcare institution if they are not already part of the same organization.

10 No reference given

Question: Will each site be developing their own implementation science protocol or will there be standardization across sites? If the latter, are there opportunities for sites using the same EMR (e.g., EPIC) to come up with similar types of modifications. Has CDC contacted any of the EMR companies (e.g., EPIC) about developing a LTBI module that might be applicable to this project?

Answer: Offerors will propose their own implementation protocol, but standardization in part or whole may occur, depending on the variety of proposed interventions, number of contracts awarded, and other factors. At this time, CDC is not planning to seek out a partnership with one specific EMR company to develop such a module.

11 No reference given

Question: Information is requested in the RFP on the time that it took our institution’s IRB to review three recent protocols.

However, the RFP requires that the local IRB defer to the CDC IRB as a central IRB. How is this requested information about review of protocols relevant if our institution is required to defer to the CDC and use a central IRB at CDC? Does having plans for a central IRB at CDC indicate there will be a common protocol across all sites? If each site has a different protocol, how can a central IRB be used?

Answer: CDC anticipates receiving proposals that share some degree of common elements, potentially enabling a multi-center study, which would require a common protocol for CDC IRB review. Offerors should clarify whether their institution will still require local IRB review in such a situation. Identifying how long the offeror’s three most recent protocols took to clear the local IRB will help CDC gauge the efficiency and flexibility of local IRBs that could potentially be involved.

12 No reference given

Question: Is a multiple Principal Investigator (MPI) format acceptable or is only a single Principal Investigator at each site allowed?

Answer: Offerors are allowed to propose multiple Principal Investigators, but must identify one lead Principal Investigator, which will be considered key personnel.

13 No reference given

Question: Can the standard NIH biosketch (5 pages) be substituted for the short CV mentioned in the RFP.

Answer: No; the resume/CV is limited to two pages.

14 No reference given

Question: Is there an “estimated cost” that should not be exceeded? On pages 2-3, there is an “estimated cost not to exceed” column but this is left blank. Can CDC provide guidance on the estimated cost that should not be exceeded for this

RFP?

Answer: The estimated cost is determined by the Offeror, based on the resources needed to complete the requirements listed in the statement of work. CDC does not provide an amount not to be exceeded.

15 No reference given

Question: Is it permissible to include a laptop computer in the budget if it is entirely devoted to this project?

Answer: Yes, but it will be considered Government Furnished Property and must be returned to CDC at the end of the task order/contract. Also, the need for purchasing a laptop must be justified in the Offeror’s proposal.

16 No reference given Question: We would appreciate it if CDC could clarify what information is being requested for in Tab 1 (page 62), “Response Assumptions”.

Answer: The Offeror shall note any relevant assumptions they have made/applied during the development of their proposed technical approach.

17 No reference given

Question: If we are collaborating with a health system that has a network of primary care health centers throughout a metropolitan area (n=10), is it acceptable to focus on a limited number of the primary health centers (that meet the requirement of >10,000 eligible patients) in the network that have large non-US born populations and subsequently expand to the entire network after developing a well-functioning system for screening, diagnosing and treatment latent TB infection?

Answer: Yes; as long as the subset of primary health care centers serve at least 10,000 patients in the required target population(s) each year.

18 No reference given

Question: Most electronic medical records (EMRs) do not collect data on patient country of birth. For the CDC TBESC II Part C study, a surrogate marker for non-US birth was used (i.e., primary language not English and/or requires interpreter services). For CDC TBESC III, is it permissible to use these variables as a marker for non-US birth?

Answer: Yes; as long as the Offeror is able to show that such a proxy will work for identifying the target population(s).

19 No reference given

Question: Is there a budget ceiling? Please advise if there are any limitations on funding, and if this will be applied per period (base, option period) or the total award issued.

Answer: No, there is no budget ceiling.

20 No reference given

Question: To confirm, should the letter of commitment come from subcontractor? Or from the specific Healthcare institution where the intervention occurs?

Answer: Letters of commitment should be obtained from the specific healthcare institution where the interventions will occur, regardless of whether that organization is directly managed/operated by the Offeror’s organization.

21 No reference given

Question: Should personnel listed under subcontract also submit their CV?

Answer: Offerors are only required to submit the resume/CV of subcontractors if the subcontractor is considered key personnel.

22 Technical proposal instructions

Question: Should past performance be from the perspective of the Offeror or the subcontractor? or both?

Answer: CDC considers the past performance of both prime contractors and subcontractors.

23 No reference given

Question: due time is listed 2PM. Is this EST?

Answer: Yes; this refers to Eastern Time.

24 No reference given Question: Is the expectation that each funded site will be working on individual projects as described in their application or will the consortium, once formed, develop a single protocol that all sites will then implement?

Answer: CDC anticipates receiving proposals that share some degree of common elements, potentially enabling a multi-center study. Standardization in part or whole may occur, depending on the variety of proposed interventions, number of contracts awarded, and other factors.

25 Page 3, Option Period 1 Question: On page 3, Option Period 1, should the travel dates be 03/29/2023 - 03/28/2024 rather than 09/29/2021- 03/28/2023?

Answer: Yes; that revision will be incorporated via amendment to the RFP.

26 page 51, K.1 - FAR 52.204-8 Annual Representations and Certifications (Mar 2020)

Question: On page 51, K.1 - FAR 52.204-8 Annual Representations and Certifications (Mar 2020) it says:

a. If the provision at 52.204-7, System for Award Management, is not included in this solicitation, and the Offeror has an active registration in the System for Award Management (SAM), the Offeror may choose to use paragraph

(d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation.

The Offeror shall indicate which option applies by checking one of the following boxes:

i. □ Paragraph (d) applies.

ii. □ Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

We do not see Paragraph (d) labeled in the application. Is this the paragraph on page 54 that is labeled (b)?

Answer: Yes; that revision will be incorporated via amendment to the RFP.

27 Page 62 Question: On Page 62, the solicitation states “The Table of Contents, Key Personnel resumes, past performance information and references, Subcontracting Plan, and Section 508 template do not count against the page limit. We are not aware of what the Section 508 template is and did not see it included in the solicitation or on the weblinks in the solicitation related to Section 508. Is this a required document for the application and if so, can you explain what it is or provide a blank copy of the document?

Answer: A 508 Product Assessment Template is mentioned in the HHSAR Clause, 352.239-74 Electronic and Information Technology Accessibility, on Page 49.

28 No reference given Question: Is there a total or estimated dollar amount available for this RFP?

Answer: The Government will not share the total or estimated dollar amount. Offerors shall propose a budget that details the resources needed to complete the activities in the statement of work.

29 No reference given Question: Is there a target number of sites for the RFP?

Answer: CDC anticipates awarding one or more contracts.

Offerors shall refer to the instructions listed on Page 71, section L.12.

30 No reference given Question: The RFP specifies that the contract format is cost reimbursable, No Fee. Would the government consider an alternative contract structure such as cost plus fixed fee or a Time and Materials contract award?

Answer: No; CDC will not consider a different contract structure.

31 Section 8 – Special Considerations

Question: Section 8 – Special Considerations: RFP indicates that the contractor adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program. Can CDC confirm if a Federal Information Security Management Act (FISMA) compliance documentation” authority to operate (ATO) will be required for this contract. If it is required, how will that impact the timeline of the study?

Answer: A federal information system is not a deliverable under this contract. Non-federal/contractors’ information systems are not governed by FISMA requirements and thus an ATO is not required. Therefore we do not expect this to impact the timeline for the study. For further clarification, this contract is requesting data (not a system) to be submitted in a format that will specified by CDC. CDC will not dictate how the contractor will collect, manage, or transform the data to reach the specified data structure requested.

32 Section 3 Scope of Work. Question: This RFP appears to be a follow-on to the Tuberculosis Epidemiologic Studies Consortium II, under which 10 separate contracts to local academic and public health sector partnerships were issued. However Section 3 states that the contractor is expected to conduct a multisite study, not serve as one site in a multisite study.

Could you please clarify the number of contracts CDC expects to issue under this RFP. In particular whether CDC expects to issue a single contract with multiple sites and a coordinating center or multiple contracts with site partnerships as in preceding consortia?

Answer: The Government expects to award one or more contracts from this RFP.

33 Section 3 Scope of Work. Question: Does CDC expect to issue a separate RFP for a coordinating center for this multi-site study?

Answer: No.

34 Section L.6 (page 62) Question: Section L.6 (page 62) states, the page limit is 30 pages. Excluded from the page limit are table of contents, Key Personnel resumes, past performance information/references, subcontracting plan and section 508 template. The past performance and subcontracting plan are outlined in the business proposal section; can you confirm that these are a part of the business proposal? Additionally, 508 is typically a part of the business proposal; can you confirm that this is a part of the technical? The 508 requirement isn’t otherwise specified within the technical or business proposal instructions.

Answer: The Subcontracting Plan and Section 508 are part of the technical proposal. The Past Performance is part of the Business proposal.

35 Section L.7(d) on page 66 Question: Section L.7(d) on page 66 details the accounting system requirements. However, it appears to apply only to those without a government approved accounting system and/or have never received a government cost-reimbursement contract. Are there requirements for those that don’t fit into those categories?

Answer: This section applies to organizations without a government approved accounting system. If an organization has one, these requirements do not apply.