Attach H - RFP QA (SPA-CC - RFP75R60222R00019).pdf

Attachment H – RFP QA (SPA-CC – RFP75R60222R00019

Attachment H Questions for HRSA Solicitation Number 75R60222R00019

Single Point of Access – Coordinating Center (SPA-CC)

1. Under the firm fixed price contract resulting from this RFP, it is our expectation that any resultant

Contractor will continue to be authorized by HRSA to utilize Government sources (GSA Federal Supply Schedules) to perform the contract. Utilization of Government sources results in significant cost savings passed on to patients (including but not limited to, reduced costs for marrow courier travel, specimen typing, sample courier shipments, etc.). Please confirm whether this expectation is correct.

a. Use of the GSA FSS must meet the requirements defined in FAR Part 51.1 – Contractor Use of Government Supply Sources.

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 (FFP) 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:

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

• 20.204-26 Covered Telecommunications Equipment or Services-Representation

(Oct 20) should be changed to 52.204-26

• 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) 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. 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, 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. 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.

7. L.4.2. – Given the requirements of the solicitation, we are including resumes 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.

8. 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.

9. Section V., Schedule of Deliverables, requires that the Contractor submit all items in the quantities and by the dates indicated to the COR. In order 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 untill the deliverable is considered approved.

10. D01, D03, and D05 under Section V. Schedule of Deliverables require meeting minutes be submitted to the COR within seven (7) business days after the meeting. Due to the voluminous nature of the meeting minutes, will HRSA change the due date to twenty-one (21) days after each meeting for each of the stated Deliverables?

a. HRSA proposes a 14 business day approach.

11. 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 party requesting the meeting”?

a. HRSA agrees to the proposed approach.

12. Deliverable 25, Analytic Support Plan for a HRSA Request, (Task 7.1) currently has varying timeframes stated within the Deliverable and PWS Task 7.1 language. For consistency purposes and due to the potential complexity of these requests and ability to plan for staff availability to respond, will HRSA revise the delivery timeframes as follows: 1) Within 14 days of request or otherwise specified; 2) Within 6 business days of request for urgent requests, revisions, or questions; and 3) within 6 business days of request if data cannot be released, is not collected, or is unavailable? Additionally, please provide clarity around the framework HRSA uses to determine whether an analytic request is urgent and thus triggers a different response timeline from the Contractor?

a. 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.

13. Delivierable 28, Quarterly Progress Report, requires quarterly submission, beginning 12/01/2022 and every four months annually after contract award. Will HRSA consider changing this delivery timeframe requirement to a Semi-annual progress report to be delivered every January 31 and July 31 during the term of the resultant contract?

a. Based on the breadth and frequency of the activities outlined in the statement of work, quarterly reporting is necessary to capture those activities and exercise adequate oversight.

14. 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.

15. 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.

16. Under Task Task 1.4 “Establish Policy and Technical Direction of the SPA-CC”, as presently written, the Contractor is obligated to submit to the COR for prior approval changes to new policies or proposed policy changes that have an impact beyond day-to-day operations of the SPA-CC. This creates the potential for substantial 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 submit to the COR for prior approval changes to NMDP Standards; polices and standard operating procedure regarding unrelated donor/patient confidential information; policy regarding Network participation; policy regarding non-compliance of Network participants; and Participation Criteria for Network participants (hereafter, the “Key Policies”)? 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 so as 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. The QASP Surveillance Matrix for Task 2.1, b) 6. states the following requirement for inclusion in the template for participation agreements: “require a notification of termination of agreements by name, network type, and location”. Because this goes to Contractor’s obligation to provide regular communication to HRSA regarding network member terminations, and does not appropriately fit within a network participation agreement, please clarify that HRSA does not require inclusion of this particular clause within the actual participation agreement template.

a. HRSA does not require inclusion of this particular clause within the actual participation agreement template. We have revised the requirement.

18. Task 2.1, Coordinate Network to Facilitate Access to Donors and CBUs, includes a Performance

Standard that requires documented assurance pertaining to non-participant transplant centers.

We are concerned that this may severely limit nonmember center access and make it more prohibitive for non-participant centers to gain access to unrelated donor or cord blood unit transplants facilitated by the SPA-CC. The current established process balances quality and clinical need assessment with the intent to ensure compassionate access through an expedited review and approval process. Please clarify HRSA’s intent and consider removal of the stated Performance Standard.

a. HRSA also would like non-participants to have compassionate access through an expedited review and approval process. However, non-network centers must submit outcomes data to the SCTOD Contractor.

19. Task 2.1 also includes a Performance Standard that establishes an expectation that corrective action plan for non-compliant network participants must be submitted to the COR for review thirty

(30) days prior to implementation. Such circumstances may require immediate resolution to protect donor and patient safety, restore compliance with applicable laws and regulations and/or safeguard the reputation of the program. The requirement as written would permit an extended period of non-compliance which we do not believe is advisable. Will HRSA consider an alternate requirement which permits immediate corrective action implementation when deemed necessary by the Contractor and with concurrent notification to HRSA?

a. HRSA agrees that in some circumstances immediate corrective action is critical to ensure patients’ safety. In those instances, the contractor may direct immediate implementation.

20. Regarding Task 3.4, Audit the Search Process and Search Process Results, because there no longer appears to be interest in this audit from the donor center and cord blood bank network, the benefit of a compulsory audit and publication of an audit report is unlikely to exceed the attendant burdens. Would HRSA consider revising Task 3.4 to require that the audit and report be completed and published upon donor center or cord blood bank request?

a. Yes. HRSA would consider revising the deliverable to include audits as requested.

21. Task 5.1, Submit Annual Recruitment and Retention Plan, makes reference to the term “supported reruits.” Please clarify the definition of the term “supported” in this context.

a. Supported recruits are generally HRSA subsidized.

22. Task 7.3, Verify the Funding Eligibility of NCBI Cord Blood Units, includes the phrase “The process shall account for the funded targets established by HRSA as well as the specific requirements set forth in the NCBI contracts.” This will require the Contractor to have access to the details included in individual contracts between HRSA and each cord blood bank. Would HRSA consider sharing those details? Until that list of details is available, it is not possible to commit to including them in our monthly process.

a. HRSA will provide the Contractor with relevant details as needed to perform this task.

23. Optional Tasks 1 through 8 include a listing of Optional Tasks that may be exercised under a resultant contract. Because it is difficult to provide a firm fixed price at time of proposal submission for tasks 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, (items f through i), to provide a price at this time and, alternatively, insert the following at Optional Tasks section, “Prior to the execution of any Optional Task, the Contractor and HRSA must negotiate, in good faith, a bilateral modification to cover the price associated with performing any Optional Task.”?

a. Prices for Optional Tasks 1 – 8 must be developed as part of the proposal.

24. Optional Task 5, Engagement with the Cord Blood Community, appears to substantially, and perhaps entirely, overlap with the requirements of Task 4.1, in which the Contractor is obligated to engage with the cord blood community in identifying and prioritizing special projects. Would HRSA consider deletion of Optional Task 5 or otherwise combining it with Task 4.1 to the extent HRSA identifies a distinction between Optional Task 5 and Task 4.1? And to the extent HRSA identifies a distinction between the two, please describe that distinction to better allow the Contractor to fulfill its obligations.

a. HRSA’s intent for the optional task is to provide opportunities for the cord blood community to meet and collaborate on cord blood transplant best practices.

25. Optional Task 8, Assess Feasibility of a Flat Fee for Searching and Procuring Hematopoietic Blood

Stem Cells: Based on the findings of a comprehensive report previously provided to HRSA by the incumbent Contractor, it appears that flat search and procurement fee pricing is not a feasible or desired alternative to the current methods of billing and recovering search costs. Would HRSA consider deletion of this Optional Task? Alternatively, please clarify market factors that warrant further analysis of this reimbursement strategy.

a. Models may change for blood stem cell transplant reimbursement. Therefore, HRSA will retain this optional task.

26. Optional Task 1, Submit Transition Plan, requires the Contractor to provide to transfer to HRSA and/or a successor contractor undefined “materials,” “data” 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 1? If not, please clarify with specificity why it will not, and propose an amendment to the language of Task 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).

27. Appendix A states what appears to be an overly broad requirement that the Contractor 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.

28. Appendix A, 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 “[e]nsure 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.

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 nonappropriated 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.

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