Attach H - RFP QA (SCTOD - 75R60222R00018).pdf

Attachment H – RFP QA (SCTOD - 75R60222R00018)

Attachment H Questions for HRSA Solicitation Number 75R60222R00018

Stem Cell Therapeutic Outcomes Database

1. In Section C, as presently written, the solicitation does not include a Section C.2 providing for Incorporation of Contractor’s Proposal. Please confirm that the final contract document will incorporate contractor’s proposal into the resultant contract.

a. HRSA does not intend to incorporate the contractor’s proposal.

2. Section F.1. “Observance of Federal Holidays” requires that no onsite services shall be performed on Federal legal holidays, holidays set forth by Presidential Executive Order and any other Government closures, including closures for inclement weather, unless otherwise provided for in the terms of the contract and that the Contractor may not bill for hours worked.

Please confirm that since Contractor’s holiday schedule may not be the same as HRSA and since this is a Firm Fixed Price Contract where invoices reflecting a fixed fee will be submitted monthly, that this Section is for information purposes only.

a. Section F.1. is for informational purposes.

3. Given that the resultant contract will be a Firm Fixed Price Contract, please confirm that items b., d., e., and f. under Section G. “Additional HRSA Invoice Requirements” are not applicable to this Solicitation.

a. Item b. pertains to all invoices regardless of contract type. Items d., e., and f. is not applicable to a FFP type contract.

4. Under Section I.1., please confirm that the following stated clauses should be referenced as follows:

i. 52.203-6 Alternate I (June 2020) should be 52.203-6 (Nov 2021)

ii. 20.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) should be changed to 52.204-26

iii. 52.224-13 Restrictions on Certain Foreign Purchases (Jun 2008) should be changed to 52.225-13 (Feb 2021)

a. Confirming the above have been corrected in the RFP, Section I.2.

5. Section I.2.2 includes a reference to FAR 52.217-9. Subsection (c) which states that the “total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.” Section B.2, however, calls for a Base Period of 1 year, as well as 4 additional one-year Option Periods and an option to extend for an additional 6 months in accordance with FAR 52.217-8. Please clarify HRSA’s intent with regard to that discrepancy.

a. The discrepancy has been revised from 5 years to 5 years and 6 months.

6. In Section K, as presently written, the solicitation does not include FAR Clause 52.227-15 “Representation of Limited Rights Data and Restricted Computer Software (Dec 2007)” which allows potential offerors to identify any technical data or computer software that qualifies as Limited Rights Data and Restricted Computer Software. Will HRSA include this as part of the solicitation?

a. HRSA has included FAR 52.227-15 provision at this time.

7. Section L.1.2 states that Volume I (Technical Proposal) must include a statement indicating whether or not any exceptions are taken to the terms and conditions of the RFP, and that any such exceptions must be noted in the proposal as well. Section L.4.1, and L.7.3.1 however, states that the Offeror’s proposal “must stipulate that it is predicated upon all of the terms and conditions of this RFP.” Our interpretation is that L.4.1. must be read to allow an Offeror to stipulate that its offer is predicated upon all of the terms and conditions of the RFP except as otherwise expressly identified in any exception(s) called out by Offeror pursuant to Section L.1.2 and L.7.3.1. Is this interpretation correct? And if not, please clarify with specificity in what way(s) this interpretation is incorrect.

a. Yes, the interpretation is valid.

8. L.4.2. – Given the requirements of the solicitation, we are including resumes/biosketches in support of the Contract Management Plan and Key Personnel requirements. Some of the individual resumes are several pages in length. May we exclude resumes from the Volume 1 – 150 pages total?

a. Please include resumes of key personnel. Offerors are advised to strictly observe limitations on the length and format specified since the Government evaluation of the proposal will be limited to 150 pages. Any pages after the 150 pages count may not be evaluated.

9. L.4.2. - We would like to include letters of support with our proposal, but these would be supplemental to the Technical Proposal, i.e., outside the 150-page limit. Is this acceptable to

HRSA?

a. Letters of support may be included, however, it will be counted towards the 150 page limit.

10. L.6, Past performance states “If the reference(s) is with a Government agency that utilizes CPARS, then Offerors shall submit their finalized CPARS ratings that are relevant to this solicitation in Volume III.” Does the full CPARS report need to be submitted as evidence of the project rating or is that information accessible to HRSA in the CPARS system?

a. If possible, please submit the report. If not, please provide the contract number and period of performance for HRSA to request access.

11. PWS Section VI, Section F.3, Schedule of Deliverables requires that the Contractor submit all items in the quantities and by the dates indicated to the COR. To ensure the timeliness of ongoing activities required under each Task, may we assume that to the extent the COR does not approve the Deliverable or ask questions about the Deliverable within thirty (30) days of receipt of any Deliverable, the Deliverable will be deemed approved by the COR?

a. HRSA will have up to 45 days until the deliverable is considered approved.

12. PWS Section VI, Section F.3, Deadlines for many deliverables in the SCTOD RFP are associated with dates that correspond with the contract performance start or end dates, which do not correspond to the beginning or end of a month. To facilitate good business principles, planning and tracking these deliverables, will HRSA consider aligning such deliverables to first or last dates of a month, as appropriate?

a. HRSA will work with the contractor after award to clarify due dates.

13. The SCTOD has previously devoted resources to support a related donor repository, and this repository has generated substantial value for the HCT community. The related repository is mentioned in the SPA-CC RFP, but is not included in the SCTOD RFP. Does HRSA intent to support a related donor repository, and if so, in which contract?

a. HRSA has updated the SCTOD PWS to align with the SPA-CC.

14. Task 1.3 Attend Special COR meetings, stipulates “contractor must respond to the COR within one (1) day of the request”. Will HRSA consider changing this language to “contractor must respond to the COR within one (1) business day”? Deliverable 4 for this Task suggests the agenda will be prepared 5 business days prior to the special COR meeting. Will HRSA change the language of this deliverable to state: “the agenda will be prepared 5 business days prior to the special COR meeting by the requester of the meeting”?

a. HRSA agrees to the proposed approach.

15. Task 3.1 states “the contractor shall make available a list of its peer-reviewed articles, as well as its datasets and summaries, on the CWBYCTP website”. “Datasets” and “summaries” represent broad terms. Please specifically define HRSA’s intent regarding “datasets” and “summaries”.

Similarly, will HRSA change this language to include “the contractor shall make available a list of its peer-reviewed articles, as well as its datasets and summaries, on the CWBYCTP website or one click away from the CWBYCTP website”?

a. HRSA requires the contractor to submit peer-reviewed articles, as well as its datasets and summaries, on the CWBYCTP website or one click away from the CWBYCTP website.

16. Under Task 1.4 “Establish Policy and Technical Direction of the SCTOD”, as presently written, provides contradictory requirements regarding review of proposed changes to polices and standards. In one location, “the contractor shall consult with the COR regarding both the proposed changes to and assessments of policies in an effort to ensure that such policies do not conflict with other components of the CWBYCTP…” Separately, “the contractor shall submit proposed changes to policies and standards to the COR, for approval, prior to their adoption and implementation.” The latter creates the potential for unnecessary oversight from HRSA regarding day-to-day operations of the contractor, undue burden and the potential for unnecessary delay having adverse impact on operation of the CWBYCTP with no commensurate benefit. In light of that, will HRSA agree, as it has historically, to remove this requirement and replace it with a requirement that “The Contractor shall consult with the COR regarding proposed changes to Key Policies in an effort to ensure that such Key Policies do not conflict with other policies established for other components of the CWBYCTP and, in the case of National Cord Blood Inventory (NCBI) units, with HRSA requirements for such units.”, where Key Policies include scope of data capture and standardization of CDEs, data validation and verification, reporting requirements, collection and reporting of cord blood data, confidentiality, and data use and dissemination? If HRSA will not do so, please clarify with specificity the reasons therefore and provide guidance as to how the stated scope might be appropriately narrowed to avoid adverse impacts to operations.

a. This is a recompetition RFP. The Contractor will need to submit policies for HRSA to review per the schedule of deliverables.

17. Task 4.1, Provide Analytic Support to HRSA, is broadly written to include several different subtasks, including “support shall include… analyzing the ideal size and composition of the NCBI, the public inventory of CBUs and the Program’s adult donor registry”. Similarly, HRSA describes “the contractor shall also support…evaluating access to care and conducting analytic activities”.

These two items appear to be potentially discrete activities distinct from others in this section.

Please clarify intended scope and definition of these activities, and frequency, if relevant.

Further, deliverable language at D14 is overly broad as pertains to the various activities contained in this task, specifically response timelines that may not match the activities. Please provide additional clarification regarding deliverables and timelines for respective activities.

a. Task 4.1 involves analytic support for multiple activities related to different program aspects. Analytic support may be performed at different timelines. The due date in the SOD and PWS was revised for consistency.

18. Task 4.1, Provide Analytic Support to HRSA, requires the contractor to “provide analytic support to HRSA, or other Federal agencies, specific to carrying (out) activities necessary for the CWBYCTP”. What other federal agencies might the contractor be required to respond to? Would the analytic support request still be made by HRSA, or potentially come directly from another federal agency?

a. HRSA may request data for use by other Federal agencies, including the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services and the National Institutes for Health.

19. Task 4.1, Provide Analytic Support to HRSA requires “the contractor shall respond to the COR

(for specific analytic needs) within 24 hours for urgent requests and within three (3) days for non-urgent requests…” Presumably this response timeline to the COR applies to “specific analytic needs”. Please clarify the requests for which these turnaround times apply. Will HRSA consider changing the language to specify “within two (2) business days for urgent requests or within five (5) business days for non-urgent requests”?

a. Thank you for your suggestion, but HRSA response time limitations require these timeframes. Every effort will be made to keep urgent requests to a minimum.

Examples of urgent requests include those from Congressional inquiries, and HRSA and HHS administration.

20. Task 5.2 currently states “The contractor shall evaluate the quality of life and late effects of allogeneic transplantation and cellular therapy and conduct related analysis, on patient late effects, that advances the field of stem cell transplantation and cellular therapy.” Is HRSA willing to consider a proposal to collect, analyze and share Patient Reported Outcomes in the response to this RFP?

a. HRSA will consider a proposal to collect, analyze and share Patient Reported Outcomes in the response to this RFP.

21. Task 6.1, Submit Monthly Progress Reports includes a status update for Task 5.1: Report on

Study Priorities in the Field of Stem Cell Transplantation and Cellular Therapy. As outlined at Task 5.1, developing a study plan with current study priorities in the field through collaboration with other professionals is relevant on a periodic basis, such as a year. The study plan and priorities are unlikely to change on a more frequent basis. Reporting on Task 5.1 on a monthly basis is burdensome and unlikely to represent any meaningful change. Will HRSA consider removing reporting on Task 5.1 from the Monthly Progress Report?

a. Yes. HRSA will consider removing reporting on Task 5.1 from the Monthly Progress Report.

22. Task 6.4, HRSA has included a description of 2-year risk adjusted survival rates for each transplant center in the Center Survival Rate Reports. Does HRSA intend to expand center performance ratings under Task 6.4 to include performance based on 2 year adjusted survival in addition to one year adjusted survival as exists in the current report? If so, please explain.

a. HRSA will revise the requirement to include one year survival.

23. Task 6.4, HRSA states “the contractor shall make the results of the analysis (Center Survival Rates Report) available to the public from the CWBYCTP website,”. Elsewhere, including Task 4.1 “the contractor shall also support making transplant center-specific survival data readily available to patients and healthcare providers, developing website content, and supporting maintenance of the CWBYCTP website.” Please clarify whether HRSA intends the SCTOD contractor to directly make the results available on the CWBYCTP website, or work with other contractors to make these results available.

a. HRSA clarifies that the contractor would work with other contractors to make these results available.

24. Throughout the solicitation, there are various references to “supporting” the CWBYCTP website, “supporting maintenance” or “making data available” on the CWBYCTP website. Please clarify the specific expectations and scope/role of the SCTOD contractor regarding the CWBYCTP website.

a. HRSA clarifies that the contractor would work with other contractors to make these results available.

25. Task 7.1 states what appears to be an overly broad requirement that the Contractor will comply with Plain Language Guidelines “when developing products” and producing “content,” and to work with the COR and program communications liaisons regarding “the content.” Please clarify the scope/definition of “products” and “content” to which this refers and describe with specificity the content for which Contractor is obligated to work with the COR and program communications liaisons for review, scoring, and enhancement.

a. Any publications paid for with HRSA funds to include documents, such as reports, manuals, brochures, fact sheets, newsletters, or any product with text and/or graphics for Web posting, electronic distribution, or printing will need to follow plain language guidelines. The CWBYCTP website must also follow plain language guidelines.

26. Task 7.2, Comply with Other Government Laws and Regulations at subsection 3, states, among other things, what appears to be an overly broad requirement that the Contractor must “ensure that all materials do not contain any non-federal logos”. Please clarify the scope/definition of “materials” to which this requirement refers.

a. HHS Private Sector or Contractor Logos on Government Publications states:

HHS components may not use private sector or contractor logos on Government publications or other Government communication products. Such use is prohibited.

Whether or not the private sector organization is non-profit or commercial is not a factor.

https://www.hhs.gov/web/policies-and-standards/web-policies/logo-contractors/index.html

Private sector logos constitute institutional advertising. Using a private sector logo on a Government communication product (regardless of intent) implies that the Government favors or endorses all that which the logo represents.

Section 13 of the Government Printing and Binding Regulations, published by the Joint Committee on Printing, United States Congress, makes clear:

"No Government publication or other Government printed matter, prepared or produced with either appropriated or non-appropriated funds or identified with an activity of the Government, shall contain any advertisement inserted by or for any private individual, firm, or corporation; or contain material which implies in any manner that the Government endorses or favors any specific commercial product, commodity, or service."

Additionally, “materials” means any and all materials that the contractor develops under the contract for the Federal Government.

27. Task 7.2, Comply with Other Government Laws and Regulations at subsection 4, states, among other things, what appears to be an overly broad requirement that the Contractor must “ensure that all materials do not contain the name of the contractor or subcontractor”. Please clarify the scope/definition of “materials” to which this requirement refers.

a. Please see response to question 26.

28. Task 8.1, Submit Transition Plan includes contingent tasks to produce written transition plans that may be exercised under the contract. It is difficult to provide a firm fixed price at time of proposal submission for this task that might not be exercised until anywhere from 1-5 years later. Will HRSA consider waiving the requirement under Section B.2., Compensation Cost/Price, (item g), to provide a price at this time and, alternatively, insert the following at Task 8.1, “Prior to the execution of any Contingent Task, the Contractor and HRSA must negotiate, in good faith, a bilateral modification to cover the price associated with performing the Contingent Task.”

Similarly, if the awarded contractor does not have a predecessor, will the government negotiate the due date of Deliverable 27 to correspond accordingly?

a. Prices for all optional tasks must be developed as part of the proposal.

29. Task 8.1, Submit Transition Plan, requires the Contractor to transfer to HRSA and/or a successor contractor undefined “materials,” “data” “data files” and “documentation.” As presently written, this could be interpreted to include copies of substantial volumes of data, materials, and documentation (including but not limited to software) developed previously without HRSA funding. Will HRSA agree to eliminate these requirements set forth in Optional Task 8.1? If not, please clarify with specificity why it will not, and propose an amendment to the language of Task

8.1 that appropriately reflects and acknowledges the Contractor’s historic and future rights in data, documents, and materials, including but not limited to those produced or obtained without HRSA funding, including but not limited to the Contractor’s rights to withhold transferring such data, documents, and materials to HRSA and/or any other third party.

a. The contractor (and/or any subcontractors) must return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. The contractor must provide data produced during the life of the contract and only information paid for by the government. The data submitted under this task is subject to FAR 52.227-14 Alternate II and the contractor may identify limited rights data under the FAR 52.227-15 provision (see Section K.8. of the RFP).