OPTN OPS - Vendor Questions and Responses (Draft RFP).pdf

OPTN Operations IDIQ Vendor Questions and Responses (Draft RFP)

ID Question Response

Can the government clarify whether the 9-artifact maximum per domain or is it 9 artifacts across all 4 domains?

Section L.3.1 is revised to read, "Offerors shall submit one (1) or more Attachment G - Prior Experience Summary, along with no more than nine (9) related case study artifacts, and no more than five (5) pages per Attachment G, for each domain for which they intend to propose. For example, Offeror proposes for Domains 1 and 3...Offeror shall submit one (1) or more Attachment G for Domain 1, with no more than nine (9) artifacts and no more than five (5) pages for Domain 1, and Offeror shall submit one (1) or more Attachment G for Domain 3, with no more than nine (9) artifacts and no more than five (5) pages for Domain 3.

2 Will the OPTN Final Rule be Changed? HRSA appreciates your question and/or feedback.

Is it 1 table per qual in the qual template based on page limit? In other words, can we use multiples tables as long as page limit is within 5 pages?

Section L.3.1 is revised to read, "Offerors shall submit one (1) or more Attachment G - Prior Experience Summary, along with no more than nine (9) related case study artifacts, and no more than five (5) pages per Attachment G, for each domain for which they intend to propose. For example, Offeror proposes for Domains 1 and 3...Offeror shall submit one (1) or more Attachment G for Domain 1, with no more than nine (9) artifacts and no more than five (5) pages for Domain 1, and Offeror shall submit one (1) or more Attachment G for Domain 3, with no more than nine (9) artifacts and no more than five (5) pages for Domain 3.

Will there be any small business domains on the IDIQ? And/or will any seats be set aside for small businesses?

Please see the Final RFP.

Regarding the statement: "The IDIQ contractor/s shall provide all services, qualified personnel, materials, equipment, and facilities needed to perform the tasks as listed in the Performance Work Statement, including the services necessary to enable the OPTN to carry out its statutory and regulatory requirements." Does the government plan to provide GFE or VDI when the Security and Privacy Requirements in Appendix B are applicable?

The Government will provide GFE or VDI access at the Task Order level, as necessary.

If a Prime/Subprime Contractor participates in any of the Transition Operations projects, are they eligible to also participate in the NextGen IT project?

Yes, a Prime or Subcontractor for the Board Support or Transition contracts may participate in the NextGen procurement.

Page 37 of the OPTN Operations Transition IDIQ states the proposal margins need to be 1 inch, however the Phase I: Prior Experience Summary (Volume 1) template’s table has less then 1 inch.

Are we require to adjust that table to the 1 inch margin or can we comply with the table margins as currently designed?

The Attachment G - Prior Experience Summary, does not require 1-inch margins.

The table on page 39, (15) specifies the page limit for volume I as "5". L.3.3 states "Volume I, Prior Experience Summaries shall not exceed 5 pages per domain". Request the Government update the table to reflect "5 pages per domain".

The Section L.1.15 table has been revised to read, "5 pages per domain" in the page limit column, for Phase 1, Vol I, Attachment G, Prior Experience Summary.

As per the Final Rule, members are responsible for payment of fees to the OPTN. How will this be achieved without the OPTN being an independent legal entity? How will the vendors be paid?

OPTN activities will continue to be paid for through fees and appropriations.

Reference to FAR 52.219-14 within Section B.3, subclause 3, sub bullet a, suggests the agency anticipates small businesses subcontracting requirements. Please clarify.

The Government encourages subcontracting with small businesses. Section B.3(a) is applicable when subcontracting is evident.

11 Question not legably identified

Will the Government ensure that successful offerors have access to the existing incumbent system? Successful awardees at the Task Order level will be provided the necessary access to perform.

Section L.1, pg-39: When does HRSA anticipate notifying offerors whether they have passed the Phase 1 down select? i.e., how much advance notice will offerors be given before the June 25th deadline for Phase 2 submissions?

The Government will do its due diligence to distribute Phase 1 Advisory Notifications as soon as possible after completion of Phase 1, to allow maximum time for Offerors to prepare Phase 2 proposals.

L.5 States: "For each domain that the Offeror is proposing, Offerors shall submit three (3) past performance references for the technical proposal where the Offeror was the prime contractor or subcontractor for relevant work completed within the past three (3) years as required by this solicitation. “Relevant” is defined as similar in size, scope and complexity to this contract." Question:

For purpose of submitting Past Performance that are relevant in size for each domain, we request the government provide the anticipated/estimated size of the task order award, by domain.

HRSA appreciates your question and/or feedback.

RFP Section L.1.15 on page 39 states page limits for each volume, and Section L.1.4 states that graphics, flow chart, organization charts, or drawings will not be counted towards the page limit for the “technical of [sic] business volume.”. Are the cover page, cover letter, and table of contents excluded from page count?

Section L.1.4 has been revised to read, "Cover page, table of contents, display graphics, flow charts, organizational charts, or drawings, will not be counted towards the page limit for the technical of business volume".

RFP Section L.1 #15 (Table) on page 39 states that the Domain Technical Proposal Page limit is 35 pages, while Section L.4 #2 paragraph 2 states the page limit for each technical proposal is 25 pages. Can HRSA please clarify the page limits?

L.4(2) paragraph 2 is revised to read, "Each technical proposal shall not exceed 35 pages for each Domain, excluding appendices."

For Section L.4.2.3 - Technical Factors for Domain 3, Organ Allocation and Distribution (Matching) System, Information Technology, and Data Are there any pre-defined SLA's and/or Performance metrics? If so can you please supply them?

No, there are no predefined Service Level Agreements (SLAs).

a.On page 39 of the letter, it states 35 pages for Phase 2 Volume III, but on page 42 it states only

25 pages. Can the Government please confirm the page count.

L.4(2) paragraph 2 is revised to read, "Each technical proposal shall not exceed 35 pages for each Domain, excluding appendices."

Appendix B. States: "The System of Records Notice that is applicable to this contract is: 09-15-0055, Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System, HHS/HRSA/HSB/DoT.

(https://www.federalregister.gov/documents/2009/11/04/E9-26527/privacy-act- of-1974-report-of-an-altered-system-of-records)." Question: Will multiple contractors be responsible for maintaining the SORN on HRSA's behalf, or will one contractor be tasked with maintaining the whole SORN?

No, HRSA has responsibility for maintaining the SORN. Contractors are responsible for operationalizing SORN components and specific details will be provided in Task Orders.

Will request to protect confidential information/data have any negative impact during evaluation phase of our proposal?

No. Information identified as proprietary or confidential will not affect evaluations.

We appreciate the opportunity to ask questions. We presume HRSA will receive many questions with some more difficult to address than others. To help industry review and update their solutions more efficiently, we request that answers to the questions be released in batches as opposed to after they are all answered.

Responses to all questions received in response to the DRAFT RFP are included in the FINAL RFP.

22 Question not legably identified

Please confirm the actual payroll records will only be needed at the task order level and, in order to determine the IDIQ rates, Offerors can use internal salaries and/or market salary surveys as support?

Payroll records may be requested when evaluating the proposed IDIQ labor rates. When requested, internal salaries and market salary surveys may be used as supporting documentation.

G.4 Key Personnel - What are the minimum qualifications for the Project Manager key personnel?

For example, is there a desire to have a minimum numbers of years' experience working in some aspect of organ transplant?

The Final PWS and RFP is revised to reflect the specific resume requirements (experience, education, etc.)

for Key Personnel to be evaluated at the time of award, and for future replacements.

During the Contract Clinic for Operations Transition, the government indicated there will be at least one sample task order included in the final RFP solicitation. If an Offeror determines the scope of a sample task order is outside its risk tolerance, will the Offeror be required to respond? If so, will the government negotiate with offerors prior to award of any sample task orders?

If the Offeror determines the scope of a sample task order is outside its risk tolerance, the Offeror will not be required to respond. However, if this is the case, and the Offeror has received an advisory notification to proceed from Phase 1, please notify the government that it no longer intends to submit proposals for Phase 2.

The summary table on page 39 of the draft RFP says the Phase 2, Vol III Domain Technical Proposal(s) are limited to 35 pages. However, section L.4 (page 42) states, “Each technical proposal shall not exceed 25 pages for each Domain.” Please confirm the maximum number of pages for the Domain Technical Proposal(s).

L.4(2) paragraph 2 is revised to read, "Each technical proposal shall not exceed 35 pages for each Domain, excluding appendices."

Reference: Instructions - 11.a. Question: Does the prior experience need to only be performed by the prime offeror, or can subcontractors also submit prior experience?

Prior Experience may include work as a subcontractor, however, the Offeror's role must be described per the requirements of Section L.3.6.

General comment. The pages do not all have page numbers and there are multiples of certain page numbers.

All page numbers are updated in the Final RFP.

In the OPTN Operations Transition IDIQ RFP page 38 of 59, can you provide a date by which the government will complete the Phase 1 evaluation and send the advisory notifications to Offerors?

The Government will do its due diligence to distribute Phase 1 Advisory Notifications as soon as possible after completion of Phase 1, to allow maximum time for Offerors to prepare Phase 2 proposals.

RFP, p.2 requests unloaded rates. Can the Government clarify how this will work for subcontractors?

For example, will subcontractors have to stay under the rate caps of their prime? To determine that, will the Government ask for rate breakdowns when billing?

Please refer to Attachment H, LCAT Pricing Template for the rate breakdown structure. Unloaded hourly rates should include only direct labor. Pricing for subcontracting will be negotiated at the Task Order level.

31 How many contracts does HRSA anticipate awarding in each individual domain? At this time, HRSA does not have an anticipated amount of awards per domain.

Will offerors be allowed to respond to both Phase I and Phase II? Section L mentions an Advisory Downselect for Phase I. Does this mean some offerors will be precluded after Phase I reviews by the Government?

The Government will provide Offerors with Phase 1 advisory feedback regarding their competiveness if proceeding to Phase 2. However, this advisory notification does not prevent the Offeror from submitting Phase 2 proposals.

RFP Section B.3 Cost Reimbursable Task Order, Section 5 Fixed Fee. The RFP states, “The Offeror shall propose a fixed fee structure for cost reimbursement and firm fixed price type Task Orders.” As firm fixed price is not a cost reimbursable type of contract, will HRSA confirm that Offerors are only required to provide a fixed fee range for cost reimbursement type Task Orders?

The fixed fee includes the Offeror's profit. Therefore, please provide a fixed fee structure for cost-reimbursement contracts only.

As I read NOTA and the Final Rule, it appears that the vendor (currently UNOS) cannot be directed by HRSA to distribute portions of the registration fees the vendor collects from OPTN members, to other vendors who win contracts for task orders. Does HRSA agree with that reading? If this is correct then all other vendors would need to be paid solely from federal appropriations allocated to

HRSA.

HRSA will provide further details on this subject at the task order level.

1.In Reference to the Main Solicitation Document, Section L.4.2.1 Pages 48-50, there are factors for each domain which are diverse by each domain. Compared to the PWS which has various task areas for each domain, this would lead me to believe that for Volume III, Domain Technical Proposal, the response should be built around the Factors compared to the Task Areas. Would I be correct in assuming that?

Correct, the response should be built around the Technical Factors compared to the Domain's tasks.

In RFP Section L.3.3 (pg. 40), it states that offerors shall use Attachment G, the Prior Experience Summary Template. However, within Attachment G, the template is labeled Attachment H. Please clarify.

Attachment G is updated, accordingly.

37 L.12 Sample Task Orders DRFP p 50: Are the sample tasks included the 35 page limit? See the Final RFP.

Would the government clarify whether vendors that participate in the Transition RFP will be OCI’d from the Modernization RFP?

The OPTN Modernization initiative encompasses the Transition procurements (Board of Directors Support and Operations Transition). Offerors involved in any OPTN related solicitations will be required to comply with the OCI requirements.

Per Section L.1 Paragraph 10, on page 38, the solicitation states: "Note that teaming arrangements, if anticipated, must be submitted in Volume I of the proposal, and once submitted, cannot be modified or altered throughout the procurement process." Does this restriction also apply to consultant agreements entered into post Phase 1 down select, post award, and/or throughout the period of performance? We anticipate there will be a need to fill niche type and level of expertise in accordance with potential changing policies and program needs throughout the contract IDIQ period of performance. Having the flexibility to bring on additional consultants with unique areas of expertise will benefit program needs and goals with the ability to effectively fill these gaps as they arise.

Please see the Final RFP.

Section G.6: To ensure that the Modernization Initiative does not stall, will HRSA commit to conducting an evaluation of contractor performance at six months from initial task order, or when more than $250K of task orders are completed, whichever comes first? Section G.7 In the spirit of transparency, will HRSA commit to making these RFTOPs publicly available and, ideally, publishing them and seeking public feedback?

Section G.6, Evaluation of Contractor's Performance refers to the requirement of FAR 42.15 and the Contractor Performance Assessment Reporting System (CPARS). CPARS is required annually. Multi-year contracts (Base and Option Periods) will have interim evaluations annually and a final evaluation at the end of the contract period of performance.

Attachment G (Phase 1 Priori Experience Summary) has a header labelled "Attachment H". please confirm that this is a typo and it should be labelled Attachment G.

Noted, and updated accordingly.

42 Does HRSA anticipate changes to the user-fee based funding model? OPTN activities will continue to be paid for through fees and appropriations.

Given that NOTA was amended to support the OPTN Modernization initiative, does HRSA anticipate proposing any changes to the OPTN Final Rule prior to finalizing the solicitations and awarding the Board Support and Operations Transition Contracts?

HRSA does not intend to change the final rule prior to contract award.

Regarding the statement: "The IDIQ contractor/s shall provide all services, qualified personnel, materials, equipment, and facilities needed to perform the tasks as listed in the Performance Work Statement, including the services necessary to enable the OPTN to carry out its statutory and regulatory requirements." Does the government plan to provide GFE or VDI when the Security and Privacy Requirements in Appendix B are applicable?

The Government will provide GFE or VDI access at the Task Order level, as necessary.

During the Pre-proposal Conference on 2/15/24, it was highlighted that an RFI will be released to understand the off-the-shelf option. Do you have an ETA for the RFI?

The RFI referenced at the Pre-proposal conference is for the OPTN NextGen and was released on SAM.gov as of 3/18/24.

Can we include ongoing Phase 1 Prior Experience Summaries or do they need to be completed experience?

Current/Ongoing experience is acceptable.

The table on page 39, (15) specifies the page limit for volume I as 5. L.3.3 states "There are no page limits for artifacts". Request the Government update the table to reflect "5 pages per domain and no page limit for artifacts".

The Section L.1.15 table has been revised to read, "5 pages per domain" in the page limit column, for Phase 1, Vol I, Attachment G, Prior Experience Summary.

Reference to FAR 52.219-14 within Section B.3, subclause 3, sub bullet a, suggests the agency anticipates small businesses subcontracting requirements. Please clarify.

The final RFP includes the Small Business Subcontracting requirments.

The OPTN Final Rule stipulates that “An OPTN member shall pay a registration fee to the OPTN for each transplant candidate it places on the waiting list”. Currently 90% of the OPTN budget arises from registration fees. Although the current OPTN contractor is designated by the HHS secretary as the OPTN so that, as a corporate entity doing business as the OPTN, it can receive registration fees and pay the contractor for its work, the PWS is silent on whether one of the operations transition contractors (or the Board Support contractor) will be designated as the OPTN for this purpose.

Given that appropriated funds fall far short of the amount needed to fund the OPTN contracts, how does HRSA envision creating or designating a corporate entity as the OPTN that can receive and distribute registration fees to contractors as needed to meet contractual obligations.

Please reference Domain 2 of the Final RFP.

Can the Government clarify how many awards are anticipated for each domain? At this time, HRSA does not have an anticipated amount of awards per domain.

Section-L.4.2.1 vs L.4.2.2., pg-44-45: Domain 1, Factor 1B asks for approaches to policy development and compliance monitoring. Factor 2D asks for a strategy for overseeing policy adherence and flagging non-compliance; Factor 2F requests approach for supporting policy development. Can HRSA clarify the distinctions in what is being requested in each?

Section-L.1, pg-37: How many days prior to the due date of Volume 1/phase 1 (4/26/2024) will the final solicitation be released?

Section L.4.2.1 requires Offerors to submit a strategy for conducting evaluations and assesmments of OPTN functions like policy development. Section L.4.2.2 requires Offerors to submit strategies for supporting different OPTN functions.

L.5 States: "If the references are with a Government agency that utilizes CPARS, then Offerors shall submit their finalized CPARS ratings that are relevant to this solicitation in Volume IV. In the case of an Offeror without a record of past performance or for whom information on past performance is not available, the Offeror may not be evaluated favorably or unfavorably on past performance."Question: In order to provide clarify regarding the combination of PPQ and/or CPARs for Volume IV, we request the government allow a 1-page introduction to Volume IV in which Offerors provide a list of provided/anticipated Volume IV content.

Not at this time, but HRSA appreciates your question and/or feedback.

For Section L.4.2.3 - Technical Factors for Domain 3, Organ Allocation and Distribution (Matching) System, Information Technology, and Data Are there any pre-defined SLA's and/or Performance metrics? If so can you please supply them?

No, there are no predefined Service Level Agreements (SLAs).

Appendix B I-3. States: "All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract: Critical-Sensitive". Question: Can HRSA clarify if all contractors/subcontractors require a critical sensitive background check, or if it will only be required for certain staff designations?

The requirement applies to certain staff and will be determined at the Task Order level.

We have submitted a large number of questions. We are attempting to submit only one question (in cell "6. Question" on this form. However, an error message is coming up "3 question(s) need to be completed before submitting: Question 10, Question 12, Question 14." Note, what is being referred to as a question "Question 10, Question 12, and Question 14" are Question Categories, and it leaves us wondering if the Government received previously-submitted content that was provided in the cells in between 5 and 15. To be able to submit our one question (6. Question above), we clicked Solicitation Section A-J in the question categories, 8, 10, 12, 14. There are no questions associated with those.

Because of the formatting limitations of MS Forms, each item on the form is assigned a number.

In the operations transition PWS documents, HRSA defines the OPTN as follows: "The OPTN currently includes the Board of Directors, operating committees, policy committees, other standing committees defined in OPTN bylaws, subcommittees, ad hoc committee and groups, OPTN review boards, workgroups, and OPTN regions." This definition does not refer to OPTN members or the public. The PWS refers in many places to “OPTN Members” and the OTPN Final Rule implies that only designated transplant programs in OPTN member hospitals can list patients, pay registration fees and receive organs for transplantation. Therefore, the OPTN must be an entity capable of having members consistent with NOTA, the Final Rule and the OPTN Bylaws. And although the Board Support Contractor or one of the operations contractors (if a non-profit) could be designated as the OPTN for the purpose of receiving OPTN fees and distributing registration fees to contractors as needed to meet contractual obligations, the PWS does not provide explicit details about how the OPTN will house and support the necessary member functions. If HRSA is not intending that the OPTN be a not-for-profit membership organization independent of the Board Support or operations transition contractors, which entity will house OPTN members in order that recipient listing and organ allocation can occur compliant with the Final Rule?

Please see the PWS in the Final RFP. OPTN members have been added to this list of OPTN entities.

Please confirm the actual payroll records will only be needed at the task order level and, in order to determine the IDIQ rates, Offerors can use internal salaries and/or market salary surveys as support?

The Government must have the information required by L.6.1; more specific cost/price information will be required and evaluated at the task order level.

G.4 Key Personnel - Is there a requirement to name the Key Personnel in the proposal? If so, which volume? Is a resume required? Will the resume count towards page count?

Yes, the Project Manager is a designated key personnel for the IDIQ contract. Please include a resume and any applicable information in Volume II, Administrative and Contract Management Approach. Resumes will not be counted in the overall page count.

During the Contract Clinic for Operations Transition, the government indicated there will be at least one sample task order included in the final RFP solicitation. If an Offeror determines the scope of a sample task order is outside its risk tolerance, will the Offeror be required to respond? If so, will the government negotiate with offerors prior to award of any sample task orders?

If the Offeror determines the scope of a sample task order is outside its risk tolerance, the Offeror will not be required to respond. However, if this is the case, and the Offeror has received an advisory notification to proceed from Phase 1, please notify the government that it no longer intends to submit proposals for Phase 2.

Reference: Solicitation General Instructions - 10

Question: Can vendors be a part of multiple teaming arrangements for the same domain? Can vendors be a part of multiple teaming arrangements across domains?

Yes, Offerors can be part of multiple teaming arrangements across domains.

General comment. The pages do not all have page numbers and there are multiples of certain page numbers.

All page numbers are updated in the Final RFP.

In the OPTN Operations Transition IDIQ RFP page 38 of 59, can you provide a date by which the government will complete the Phase 1 evaluation and send the advisory notifications to Offerors?

The Government will do its due diligence to distribute Phase 1 Advisory Notifications as soon as possible after completion of Phase 1, to allow maximum time for Offerors to prepare Phase 2 proposals.

Would Government confirm that the unloaded labor category ceiling rates would not apply to T&M and or Labor Hour contract types so far as the aforementioned contract types are invoiced at and do not exceed the fully loaded rates by LCATs for each Domain.

The unloaded labor category ceiling rates will be used for the Cost-reimbursement contract.

Will HRSA or the OPTN request or approve all analyses or will the Transition Contractor have autonomy in pursuing analytic work?

Approval of analyses will be detailed at the task order level. Analyses may be approved by HRSA in consultation with the OPTN where appropriate.

Is a separate VPAT volume required? VPAT is not required at the IDIQ level, however it will be required at the Task Order level.

RFP Section B. Section B.2 states that individual Task Orders may be awarded under different contract types (cost reimbursement, cost share, labor hour, time and material, firm-fixed price, or any combination), but Section B.3. only requests information relevant to cost reimbursable Task Orders (cost share, labor hour, T&M, CPFF). Will HRSA consider amending the RFP to include a description of firm-fixed price Task Orders and clarify the IDIQ enables the issuance of both cost-reimbursable and firm-fixed price Task Orders during performance?

Individual Task Orders may be awarded as a FFP, Cost-share, Cost-reimbursement, and Time & Materials, or any combination thereof. Section B.3 is applicable to cost reimbursable Task Orders only.

Please describe how to handle sample task response in detail. The Offeror will be required to submit a Business Proposal and a draft Quality Assurance Surveillance Plan with proposed SLAs for each awardable Task Order and the Domain 2 Sample Task Order.

Would the government clarify whether vendors that participate in the Transition RFP will be OCI’d from the Modernization RFP?

There is no conflict of interest at the IDIQ level. There may be potential for conflicts of interest at the Task Order level, those will be identified appropriately.

Section H.1: Minimum Eligibility Requirements

Especially in light of recent revelations of a federal probe into potential kickbacks among OPTN members, how will HRSA verify the independence of any vendors, including of their principals, when selecting contractors? In such an assessment of independence, will HRSA also assess recent conflicts over the past 2-5 years, rather than just current conflicts? Will HRSA clarify what operational independence includes, such as not being controlled by the same majority people/leadership/board as any OPTN Operations IDIQ contractor or subsidiary, etc.?

Section H.2: Organizational Conflict of Interest

To ensure that conflict of interests policies are sufficient to limit and mitigate actual and potential conflicts, will HRSA consider the following suggested edits?:

“Ongoing Contractor Monitoring and Mitigation: The Contractor shall have programs in place to limit, identify, report to HRSA, and mitigate actual and potential conflicts of interest for itself, its employees, and its board members, subcontractors and consultants. This includes providing information about such programs to applicants for positions that will complete work under this contract and to potential Contractor board members and officers, so as to limit conflicts of interest to the extent possible. Any proposed mitigation plans must be approved by HRSA. Once final, HRSA will post such mitigation plans, conflict disclosures, and waivers, if any, on a publicly available website. The existence of such programs and the disclosure of known actual or potential conflicts are material performance requirements of this contract.”

Please refer to the RFP, which details OCI requirements, as well as the PWS, which addresses OCI between the OPTN Board of Directors and OPTN contractors. Additonally, OCI will be addressed at the task order level.

Can the government provide more information on the types of key personnel that will be required at the task order level?

Please see the Final RFP.

Can multiple past performances/quals be included for attachment G or just one? Section L.3.1 is revised to read, "Offerors shall submit one (1) or more Attachment G - Prior Experience Summary, along with no more than nine (9) related case study artifacts, and no more than five (5) pages per Attachment G, for each domain for which they intend to propose. For example, Offeror proposes for Domains 1 and 3...Offeror shall submit one (1) or more Attachment G for Domain 1, with no more than nine (9) artifacts and no more than five (5) pages for Domain 1, and Offeror shall submit one (1) or more Attachment G for Domain 3, with no more than nine (9) artifacts and no more than five (5) pages for Domain 3.

The OPTN Final Rule stipulates that the HHS Secretary will designate a private not-for-profit entity as the OPTN. What organization will the Secretary designate as the OPTN? The Board Support Contractor? A new, independent OPTN not-for-profit entity? One of the other OPTN contractors?

For details on the new independent OPTN entity, please see the OPTN Modernization website.

73 Can the same qual be used for more than one domain? No.

L.3 Phase 1: Advisory Down-Select, Prior Experience Summaries (Volume I), Page 41. Could you please clarify what is meant by the following? "Delivery Methodology: Specify the delivery methodology or approach used for the project."

For the Prior Experience Summary, the Offeror may consider "delivery methodology or approach used for the project" as asking how services were rendered and outcomes achieved. HRSA defers to the Offeror on how to address this question.

In regards to Appendix B, Section III Procurements Involving Government Information Processed on GOCO or COCO Systems: Please clarify whether this clause applies to systems owned and operated by a vendor (i.e. a vendor's HR system) or whether this applies to government owned systems within scope of the RFP? If applicable to systems within the scope of this RFP, please update the clause accordingly to state the applicable GOCO or COCO system(s). Otherwise, vendors may not be able to comply given the existence of systems with classified information, business confidential and/or client confidential information with access restrictions.

Appendices A, B, C, and D will be specified at the Task Order level as appropriate and necessary.

If a Prime/Subprime Contractor participates in any of the Transition Operations projects, are they eligible to also participate in the NextGen IT project?

Yes, a Prime or Subcontractor for the Board Support or Transition contracts may participate in the NextGen procurement.

77 When will the Sample Task Orders be posted? Sample Task Orders are available in the Final RFP.

"The Prior Experience Summaries shall not contain references to price/cost; however, resource information such as labor hours and categories, materials, and subcontracts/teaming agreements may be included." Would the Government confirm that Offerors are not required to include labor hours and categories, materials, and/or teaming agreements with their phase 1 proposals?

Yes.

HRSA has stated that they are committed to providing insurance for volunteers. What is the status of this? How will volunteers be protected? Can HRSA provide assurances that routinely used Directors & Officers (D&O) insurance is sufficient to safeguard OPTN Board members? We do not believe this is sufficient for the OPTN, please explain your rationale.

Please reference the Board of Directors (BOD) solicitation.

Section B.3 opens with: "in accordance with the requirements stated in the contract, and in consideration of the satisfactory performance of the work performed in Section J, Attachment A, Performance Work Statement, the Government will reimburse the contractor on a cost-reimbursement basis for task orders of this type." The use of the term "satisfactory performance" is subjective without alignment to clear and measurable performance requirements. Please consider revising or providing objective and measurable performance requirements when issuing Cost Reimbursable Task Orders under the IDIQ.

Pursuant to the CPARS metrics, which is the system used to measure and record Contractor performance annually, to justify a "satisfactory performance" rating, there should have been only minor problems, or major problems the contractor recovered from without impact to the contract/order. There should have been NO significant weaknesses identified. A fundamental principle of assigning ratings is that contractors will not be evaluated with a rating lower than Satisfactory solely for not performing beyond the requirements of the contract/order.

Can the Government clarify how many awards are designated to small business set-aside per domain?

The Final RFP will identify the the Small Business requirements.

Section L.3, pg-40: Please confirm that offerors who are planning a team arrangement with subcontractors, prior experiences of all subcontractors should be included in a single 5-page experience summary and NOT separate summaries be completed for each contractor/subcontractor/consultant in the team arrangement?

Section L.3.1 is revised to read, "Offerors shall submit one (1) or more Attachment G - Prior Experience Summary, along with no more than nine (9) related case study artifacts, and no more than five (5) pages per Attachment G, for each domain for which they intend to propose. For example, Offeror proposes for Domains 1 and 3...Offeror shall submit one (1) or more Attachment G for Domain 1, with no more than nine (9) artifacts and no more than five (5) pages for Domain 1, and Offeror shall submit one (1) or more Attachment G for Domain 3, with no more than nine (9) artifacts and no more than five (5) pages for Domain 3.

Appendix C; Attachment C 508 Compliance. In the PWS, there is an Attachment C (pg. 41 of 51) and another Appendix C (pg. 45 of 51).Question: Both address similar, but not identical information, e.g., the first paragraph of these sections are not identical. We request that the government remove the duplicative and/or appended section that has incorrect information.

Not at this time, but HRSA appreciates your question and/or feedback.

RFP Section K identifies Representations and Certifications, some of which require signatures.

However, it is not clear in Section L which Volume the completed Representations and Certifications should be attached to?

Please see the Final RFP.

PWS Domain 3 Task 3.2 #3 on page 20: Can HRSA please specify its preferred cloud providers? No. HRSA prefers the Office of Management and Budget’s Cloud Smart strategy.

Page 18 says "services required for the OPTN Kidney Paired Donation pilot program (KPDPP)"

Can HRSA please clarify whether Kidney Paired Donation pilot program uses the same system/ technology used for the OPTN program? Or is this a new initiative or system development?

Please visit the following website for this information: https://optn.transplant.hrsa.gov/patients/about-donation/living-donation/kidney-paired-donation-for-patients/.

Prior Experience Summary - Phase 1, Volume I:

Can more than one prior experience be submitted per domain?

More than one prior experience may be submitted per domain.

Section L.5. States: "For each domain that the Offeror is proposing, Offerors shall submit three (3) past performance references for the technical proposal where the Offeror was the prime contractor or subcontractor for relevant work completed within the past three (3) years as required by this solicitation. “Relevant” is defined as similar in size, scope and complexity to this contract."Question:

Can HRSA clarify if prime offerors can include past performances from a proposed subcontractor as part of it's proposal response?

The Prime shall submit three (3) past performance references for each domain in which they intend to proose via Attachment E - Past Performance Questionnaire. Section L.5, paragraph 2, is revised to add, "A Prime's submission may include prior experience/past performance of their subcontractor, as long as the summary clearly demonstrates the Primes predominance in the participation and performance, and ability to meet the past performance evaluation criteria metrics."

Having hit submit, and not receiving an error message, we were directed back to the company information page. We did not receive acknowledgement that questions were submitted. Therefore, we're filling in this information; however, we have no additional questions at this time.

HRSA appreciates your feedback.

In Domain 4, task 4.1, items 3 and 5 refer to requiring “OPTN and HRSA approval” to “prepare presentations and articles for external public…” and “plan and host consensus conferences…” What does “OPTN” mean in this context? The OPTN Board or other OPTN volunteers or an OPTN employee? Item 7 also refers to “engaging the OPTN Board of Directors and HRSA on responses” to media issues related to the OPTN. In the current state, the OPTN contractor is not required to seek OPTN Board approval for all items. A requirement that all items require prior approval by the OPTN Board and the HRSA COR risks preventing timely communication of issues to OPTN members and the public, including time sensitive safety issues. Requiring OPTN Board approval of all items explicitly listed, including media responses, may be overly burdensome to these volunteers.

Please clarify how these constraints will not impact time-sensitive issues or overly burden OPTN volunteers.

Specific points of contact will be identified at the task order level. This includes both HRSA and OPTN representatives. The specifics of what needs to be approved ahead of time and the timeframe for such approvals, inlcuding the process for managing approvals, would be identified at the task order level.

Please confirm that Offerors can use DCAA approved and established Provisional Billing Rates when establishing their indirect costs.

Yes. As stated in L.6.1 of the RFP, organizations shall provide a copy of their current negotiated indirect rate agreement with the Federal Government. If the organization does not have an established indirect cost rate, supporting information for any proposal rate shall be submitted including a description of cost allocation methodology used and justification with supporting documentation.

G.4 Key Personnel - Will the qualifications of the key personnel be considered an evaluation factor for vendor selection as an awardee of the IDIQ? If so, is that a consideration in Volume II, FACTOR A - Approach to Task Order Fulfillment and Continuous Improvement?

Please see the Final RFP.

Per the proposal submission breakdown example provided on page 39, please confirm that offerors are to submit separate Phase 1 proposals (Prior Experience Summary) per Domain if submitting for multiple Domains.

Yes.

Reference: L.12 - Sample Task Orders

Question: Can the government clarify that each Domain will have its own sample task order? Is responding to the sample task order mandatory?

Awardable Task Orders and the Sample Task Order for Domain 2 are included in the Final RFP.

Page 37 of 59, Section L.1.4. Can the government please clarify the statement: “Display graphics, flow charts, organizational charts, or drawings, which will not be counted towards the page limit for the technical of business volume.”

Section L.1.4 has been revised to read, "Cover page, table of contents, display graphics, flow charts, organizational charts, or drawings, will not be counted towards the page limit for the technical of business volume".

In the OPTN Operations Transition IDIQ RFP page 41 of 59, the Prior Experience Summary for task 1 asks for experience with “customer impact.” In this domain, are you looking for examples of impact of transformation services on decisions made by the funder? Or broader impacts on policy and practice?

Please see the Final RFP.

Section B.3 states, "Each task order awarded under the contract on a cost-reimbursement basis shall include one or more of the labor categories in Section B.2, proposed labor rates for specific contracts shall not exceed the maximum rates set forth in B.2." Is this the Government's intent to cap cost reimbursable rates rather than reimburse the contractor for actual cost incurred?

Yes, for labor categories.

What is the expected start date for the period of performance? While the exact start date is still unknown, HRSA anticipates a start date by the end of the calendar year

2024.

Attachment F - Considering that the solicitation is for an IDIQ and the task order awards are unknown, will the Government specify what contract dollar amount large business Offerors should use for the Subcontracting Plan to demonstrate how small businesses will be used throughout the period of performance?

Attachment F of the 2024 Subcontracting Plan and percentage and financial goals is included in the Final

RFP.

Attachment H. Some vendors intending to team with a Prime contractor, as a Subcontractor, do not perform services on an hourly nor Cost-Reimbursement basis and exclusively perform on a Firm- Fixed Price basis. For this reason, HHS agencies have regularly benefited from expanding pricing requirements to allow for fixed price bids based upon a vendor’s detailed description of the project in their technical response and their respective commercial pricing practices at the Task Order level.

This approach enables more cost-effective options, transfers potential schedule and cost risk to the bidder, incentivizes bidder efficiency, eases agency project management burden, and ensures maximized competition and an inclusive procurement open to all qualified bidders. Given Offeror (and Subcontractor) limitations to perform on a cost reimbursable basis and HRSA’s ability to assess price reasonableness on the basis of adequate price competition, will HRSA amend the solicitation instructions in Section B., and in Attachment H LCAT Pricing Template, to expand the acquisition method to allow Offerors (and Subcontractors) to complete a Cost-Reimbursement and/or Firm Fixed Price rate cards for the IDIQ to establish maximum ceiling rates for each type of future Task Order?

No, but HRSA appreciates your question and/or feedback.

As I read NOTA and the Final Rule, it appears that the vendor (currently UNOS) cannot be directed by HRSA to distribute portions of the registration fees the vendor collects from OPTN members, to other vendors who win contracts for task orders. Does HRSA agree with that reading? If this is correct then all other vendors would need to be paid solely from federal appropriations allocated to

HRSA.

HRSA will provide further details on this subject at the task order level.

The solicitation mentioned Next gen contracts several times, but can you clarify the OPTN Operations Transition solicitation and how it will transition to the next gen specifically for Domain 3 – IT services where modernization is mentioned as well.

Specific requirements for support for NextGen IT contracts by OPTN Operations IDIQ holders will be provided at the Task Order level. These separate solicitations serve unique purposes and will run concurrently.

In RFP Section L.3.7 (pg. 41), it states that offerors may submit Artifacts from a single Prior Experience Summary or multiple Prior Experience Summaries. Are the multiple Prior Experience Summaries for one domain to be described within one single Attachment G Template and not to exceed 5 pages?

Section L.3.1 is revised to read, "Offerors shall submit one (1) or more Attachment G - Prior Experience Summary, along with no more than nine (9) related case study artifacts, and no more than five (5) pages per Attachment G, for each domain for which they intend to propose. For example, Offeror proposes for Domains 1 and 3...Offeror shall submit one (1) or more Attachment G for Domain 1, with no more than nine (9) artifacts and no more than five (5) pages for Domain 1, and Offeror shall submit one (1) or more Attachment G for Domain 3, with no more than nine (9) artifacts and no more than five (5) pages for Domain 3.

H.2 Organizational Conflict of Interest DRFP p 15:

Will participation in this OPTN Operations Transition IDIQ create a conflict of interest for awarded companies to participate in the Next Gen contract?

There is no conflict of interest at the IDIQ level. There may be potential for conflicts of interest at the Task Order level; those will be identified appropriately.

Would the Government be receptive to solutions that require the procurement commercial software as part of the Transition IDIQ?

Yes, the Government is open to commercial solutions.

L.3.8 – Domain 1 Prior Experience - Transformation Services:

Will HRSA include experience in change management in complex organizations, as well as experience in facilitation, moderation, conflict, and human-centered design and journey/process mapping?

L.3.8 – Domain 2 Prior Experience – OPTN Operations:

Given that all governance and committee work should be in the board support contract, will HRSA remove references to “governance” and “policy development” experience?

L.3.8 – Domain 3 Prior Experience – IT and Data:

Will HRSA include additional requirements for vendors to demonstrate proof of past cybersecurity and privacy practices?

L.3.8 – Domain 4 Prior Experience – Communications: Will HRSA include additional requirements asking for evidence of past work to support public engagement and participation programs/campaigns, as well as experience in inclusive communication that reached diverse audiences?

L.4.1 Volume II, Administrative and Contract Management Approach:

Will HRSA add any factors related to ethics, accountability, and transparency?

L.4.2.3 Technical Factors for Domain 3, Organ Allocation and Distribution (Matching) System, Information Technology, and Data

Will HRSA break privacy into its own factor bullet separate from security, and consider adding a bullet on data sharing, specifically as it relates to support for data sharing among OPTN contractors, the Board, and HRSA?

Please see the Final RFP.

Can the government provide information on the existing system architecture? The incumbent system is contractor-owned, contractor-operated, and HRSA is unable to provide the requested information on it's technological make-up. Further information may be available after specific Task Order awards.

In Phase 2 Vol III, is the page limit 25 pages or 35 pages (it is listed differently in two different places)?

L.4(2) paragraph 2 is revised to read, "Each technical proposal shall not exceed 35 pages for each Domain, excluding appendices."

How will fiscal authority be implemented in the new structure? The OPTN Final Rule stipulates that the Secretary must approve the OPTN registration fee but is otherwise silent on fiscal issues. The PWS documents are silent on authorization of payments. Will the OPTN Board have full fiscal authority, will HRSA, or will authority reside in some combination of the two?

HRSA will continue to pay for OPTN activities through fees and appropriations.

Is the 9-artifact maximum per domain or is it 9 artifacts across all 4 domains? Section L.3.1 is revised to read, "Offerors shall submit one (1) or more Attachment G - Prior Experience Summary, along with no more than nine (9) related case study artifacts, and no more than five (5) pages per Attachment G, for each domain for which they intend to propose. For example, Offeror proposes for Domains 1 and 3...Offeror shall submit one (1) or more Attachment G for Domain 1, with no more than nine (9) artifacts and no more than five (5) pages for Domain 1, and Offeror shall submit one (1) or more Attachment G for Domain 3, with no more than nine (9) artifacts and no more than five (5) pages for Domain 3.

L.3 Phase 1: Advisory Down-Select, Prior Experience Summaries (Volume I), Page 40. Can prior experience summaries include projects completed by our subcontractors?

No, but HRSA appreciates your feedback.

Regarding this statement: "b. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO within 14 days before an employee stops working under this contract." In some cases, an employee may resign…