SRTR RFI.pdf

REQUEST FOR INFORMATION (RFI)

Agency/Office: Department of Health and Human Services (HHS) / Health Resources and Services Administration (HRSA) / Office of Acquisition Management and Policy (OAMP)

Contracting Office Location: 5600 Fishers Lane, Rockville, MD.

Title: Scientific Registry of Transplant Recipients

NAICS Code: 541611 – Administrative Management and General Management Consulting Services

Incumbent: Hennepin Healthcare Research Institute

Estimated Contract value: $32,500,000.00

Response Due Date: August 11, 2025

Introduction

In accordance with Federal Acquisition Regulation (FAR) 52.215-3 Request for Information or Solicitation for Planning Purposes, the Health Resources and Services Administration (HRSA) is issuing this Request for Information (RFI) solely for market research and planning purposes. This notice is not a solicitation. The Government does not intend to award a contract based on responses to this RFI. While terms such as “proposal” and “offeror” may appear herein, your response will be treated as information for market research only. It shall not be used as a proposal.

Background

The National Organ Transplant Act (NOTA; P.L. 98-507) established the Organ Procurement and Transplantation Network (OPTN) to coordinate and improve the effectiveness of the nation’s organ procurement, distribution and transplantation systems and to increase the availability of, and access to, donor organs for patients with end-stage organ failure. NOTA also amended the Public Health Service Act to require the establishment, “by grant or contract,” of a Scientific Registry of Transplant Recipients (SRTR) to support ongoing evaluation of the scientific and clinical status of solid organ transplantation.

Regulatory responsibilities of the SRTR are outlined in NOTA’s implementing regulations (also known as the “Final Rule”). 42 CFR 121.11 et seq. https://www.ecfr.gov/current/title-42/chapter- I/subchapter-K/part-121

Purpose of the RFI

HRSA anticipates releasing a formal Request for Proposal (RFP) in the coming months for the next SRTR contract. This RFI seeks input from Industry and stakeholders to inform the development of the RFP and to assess interest and capabilities within the market.

HRSA’s Key Objectives for the Upcoming SRTR Requirement

HRSA’s primary objectives for improvements in the contract arrangement that results from the forthcoming RFP are to:

https://www.ecfr.gov/current/title-42/chapter-I/subchapter-K/part-121 https://www.ecfr.gov/current/title-42/chapter-I/subchapter-K/part-121

1. Increase operational efficiency in SRTR support of the Organ Procurement and Transplantation Network under statutory requirements;

2. Identify and reduce duplicative functions among HRSA, SRTR, and other OPTN contract entities.

3. Maintain and enhance accessibility and utility of SRTR data files and tools for all system stakeholders; and

4. Leveraging the SRTR database to improve transparency and accountability in the organ procurement, allocation, and transplantation process.

This RFI seeks to:

1. Solicit feedback on ways to enhance components of the SRTR contract, including data synthesis, transparency of analysis, and analytical support to the OPTN, the Health Resources and Services Administration (HRSA), and the United States Department of Health and Human Services (HHS).

2. Gauge interest in the upcoming RFP opportunity via statements of intent from prospective offerors.

3. Gain insight on ways to better utilize new and existing data sources and technology to optimize the SRTR and better meet patient and donor needs.

At this stage of the acquisition process, HRSA will not be responding to questions from vendors or members of the public.

MARKET RESEARCH QUESTIONS

Respondents may provide responses to any of the “Market Research Questions” below. Please cite the question number when responding. Respondents are NOT required to respond to each question.

We are seeking the most impactful best practice insights, technology recommendations, and suggested optimization strategies pertaining to the activities described below.

HRSA is seeking responses to the following questions:

1. What metrics should the government use to measure the success and impact of the SRTR in meeting its users’ needs?

2. Describe how the SRTR will leverage currently available data (including existing data linkages) and identify new data sources to improve identification of issues impacting patients’ access to organs. For example, what data should the SRTR collect to better understand and address allocation out of sequence?

3. How should data tools look different for different users, including smaller-volume transplant centers and patients who live a significant distance from a transplant center?

4. Organ procurement and transplant data can be very complex and nuanced. Provide an example of complex procurement and/or transplant data and how it could be presented in a way that can be easily understood.

5. Describe how the SRTR could better support access to data and collection of data needed to increase accountability for organs lost, damaged, or delayed in transport.1

6. Provide recommendations for strategies the SRTR could apply to ensure transparency of data collection and enhance data needed for effective oversight of OPTN member compliance with regulatory requirements of organ allocation.

7. Describe suggestions for incorporation of contract requirements to increase SRTR’s technical ability to use existing regulatory standards and ensure appropriate alignment with other federal agencies, including the Centers for Medicare & Medicaid Services.

8. Describe challenges or barriers that you see for small transplant programs seeking to leverage SRTR data for quality improvement purposes. How can the information be made easier for smaller programs?

9. If stakeholders aren’t getting information they require from SRTR, please explain, and suggest sources or improved processes to obtain the needed data (if known).

10. Make recommendations for re-structuring SRTR contract requirements to eliminate redundancies with other OPTN contract activities.

11. What specific prior experience should a vendor be able to demonstrate to be considered qualified to meet and excel at SRTR contract requirements?

12. What services are most essential to effective operation of the SRTR?

13. What other services (government or commercial, e.g. the Medicare Care Compare tool) could SRTR integrate that would add value to existing SRTR activities?

1 Note congressional concern for the safety of organ transport. Section 1102 of the Federal Aviation Administration (FAA) Reauthorization Act of 2024 (H.R. 3935) requires:

(a) In General.—Not later than 90 days after the date of enactment of this Act, the Secretary, in consultation with the Administrator, shall convene a working group (in this section referred to as the “working group”) to assist in developing best practices for transportation of an organ in the cabin of an aircraft operating under part 121 of title 14, Code of Federal Regulations, and to identify regulations that hinder such transportation, if applicable.

THIS RFI IS STRICTLY FOR MARKET RESEARCH PURPOSES.

RESPONSES REQUESTED

Interested parties are encouraged to respond to this notice.

The Government is requesting industry input by responding to the questions and by providing any applicable reference materials. This information may be used to revise, if necessary, any procurement documentation in support of a future solicitation, and may be released via SAM.gov.

Please submit your responses by August 11, 2025, to Nancy Lee at nlee@hrsa.gov in the following format:

Microsoft Word (or PDF) document with page size 8.5 by 11 inches, with a minimum of 1” margins.

Times New Roman, font size 12 with single spacing between lines.

Submission shall not exceed 10 pages. The cover page and statement of intent are not included in the total page count.

Respondents shall provide the following information to HRSA:

A. Provide a cover page with the following Business information:

1. Notice number, title, and date of issuance

2. Name

3. Address

4. Point of Contact (if applicable), Phone and Email address

B. Responses to Questions. Please cite the section and the question number when responding.

C. Statement of intent to supply a proposal on any future solicitation related to this requirement.

CONFIDENTIALITY

To the maximum extent possible, please avoid submitting confidential or proprietary information.

Any confidential or proprietary information submitted shall be marked as such and will be protected from disclosure except as required by law. The Government reserves the right to use and release any unmarked information in any future solicitation(s). While the information obtained from responses to this RFI may be used for planning purposes, and/or in the development of an acquisition strategy or solicitation, there is no guarantee that any solicitations will result from this notice. Respondents are responsible for appropriately marking confidential or proprietary information contained in their responses.

DISCLAIMER AND IMPORTANT NOTES

This notice does not commit the Government to issue a solicitation, award a contract, or constitute an obligation of Federal funds. The Government reserves the right to use and release information provided by respondents for any purpose deemed necessary and legally appropriate.

Any organization responding to this notice regarding its capability to respond to the future solicitation should ensure that its response is complete and detailed enough to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Responses to this notice will not be considered adequate responses to a solicitation.

All submissions in response to this RFI, including attachments and other supporting materials, will become part of the public record and may be subject to public disclosure including publication by HRSA. Please do not include in your submission sensitive personal information, such as account numbers or Social Security numbers, or names of other individuals, or other information that you would not ordinarily make public, such as trade secrets or confidential commercial information. Submissions will not be edited to remove any identifying or contact information, or other information that you would not ordinarily make public.

Respondents will not be notified of the results of this market research. Responses will not be returned.