Sources Sought Notice SRTR 6-1 7-2020.pdf

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Sources Sought Notice

Agency/Office: HHS/HRSA/OAMP Contracting Office Location: 5600 Fishers Lane Rockville, MD 20857 Title & Number Scientific Registry of Transplant Recipients

HSB 115 C 2534

NAICS Code: 541611 Incumbent: Hennepin Healthcare Research Institute Response Due Date: 6 /26 /2020

This is a SMALL BUSINESS SOURCES SOUGHT NOTICE (hereafter referred to as “notice”) issued for the purpose of planning and market research. This is NOT a solicitation for proposals, proposal abstracts, or quotations and this does not obligate the Health Resources and Services Administration (HRSA) to award a contract now or in the future.

THIS IS STRICTLY MARKET RESEARCH. No reimbursement will be made for any costs associated with providing information in response to this announcement and any follow-up information requests. Respondents will not be notified of the results of the capability assessment. The Government will not entertain questions regarding the results of this market research, and requests for additional information will not be honored. All information submitted in response to this announcement must arrive on or before the closing date. The Government reserves the right to use any submitted data in a resultant solicitation.

The purpose of this notice is to obtain information regarding the availability and capability of qualified small businesses only (including 8(a), service-disabled-veteran-owned-small business (SDVOSB), Historically Underutilized Business Zone (HUB Zone) small business, small disadvantaged business (SDB), veteran-owned small business (VOSB), and women-owned small business (WOSB) to operate the Scientific Registry of Transplant Recipients (SRTR).

The Contractor will be responsible for providing statistical and other analytic support to the Organ Procurement and Transplantation Network (OPTN) for purposes including the formulation and evaluation of organ allocation and other OPTN policies. Additionally, the Contractor will provide analytic support to HHS in a variety of areas including: policy formulation and evaluation, system performance metrics, economic analysis, and preparation of recurring and special reports to Congress.

This sources sought notice is seeking responses from small businesses.

Background:

The SRTR is mandated under the National Organ Transplant Act (NOTA) of 1984, as amended.

The SRTR is authorized under 42 U.S.C. 274a. The authorization stipulates, "the Secretary shall, by grant or contract, develop and maintain a scientific registry of the recipients of organ transplants...." Although there are been several amendments to NOTA over the years, the authorizing statute for the SRTR has remained the same. The work conducted under the SRTR is also guided by the OPTN final rule, 42 CFR 121, as amended. The OPTN final rule was initially published in 1999.

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Project Requirements

1. Serving as the primary analytic resource to the OPTN and HHS. The SRTR Contractor shall provide analytic expertise to support analyses of a broad range of issues relating to: transplant waitlist and post-transplant outcomes evaluation; the evaluation of existing OPTN policies; the likely impact of proposed OPTN policies; and the operation and performance of the OPTN members and the OPTN as a whole.

2. Storage, maintenance and protection of data supplied by the OPTN. This data includes information on: patient registration on the transplant waitlist; transplant procedure or removal from the transplant waitlist; and follow-up of both transplant recipients and living donors following transplantation. The OPTN also collects information about the organ donor and the disposition of organs retrieved from each donor.

3. Supplementation of OPTN data with available external data sets to develop ongoing analytic datasets for the purpose of conducting analyses in support of the OPTN and HRSA, and for making a subset of these data available for bona fide research.

4. Arrangement for the transfer of and eventual real-time access to all OPTN data collected under the OPTN contract.

5. Establishment and maintenance of a collaborative working relationship with the OPTN, committees and members of the OPTN, and other entities within HHS such as the Centers for Medicare and Medicaid Services (CMS), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), the National Center for Health Statistics (NCHS), the Secretary’s Advisory Committee on Organ Transplantation (ACOT), and other members of the transplant community.

6. Construction and maintenance of Standard Analytical Files and creation of a Living Donor Registry data file.

7. Maintenance and improvement of SRTR websites for dissemination of transplant information to the public and the transplant community.

Capability Statements

In response to this notice, HRSA is seeking capability statements from small businesses who can demonstrate experience commensurate with operation of an entity such as the SRTR. Capability statements are NOT proposals and do not address price/cost. Vendors are asked for information which proves that they have expertise and capacity to meet the requirements of this work.

Respondents should provide enough information for HRSA to make an informed determination

3 | P a g e of their capability to perform the work. Please provide a list of contract numbers that your organization has had (if applicable), your role on the contract (prime contractor or subcontractor) and the dollar value/percentage of the work performed. If you were a subcontractor on a particular contract, please clarify the work that you did on that contract. Respondents are requested to state their capabilities and expertise in clear and concise language.

No marketing literature should be submitted in response to this notice.

A mere statement that the vendor has a required capability is not sufficient.

When answering the following questions, vendors must provide specific and detailed examples of work that was performed that demonstrates required capabilities and the attendant level of effort that was involved.

1. Do you have knowledge and experience of the respective roles of HHS, OPTN, SRTR, and organ procurement organizations (OPOs)?

2. Do you have knowledge and experience of the impact of the SRTR analytical work on the OPTN organ allocation and distribution policies and the practices of OPOs and transplant programs?

3. Do you have knowledge and experience creating and maintaining a large database in health care with the capability of conducting analysis using complex algorithms including performing risk- adjusted survival analysis?

4. Do you have knowledge and experience receiving and disseminating data and datasets to and from multiple organizations (including experience in establishing and maintaining the necessary relationships to ensure these data are obtained)?

5. Do you have qualified available personnel with a range of clinical expertise to meet the requirements of directing the project and supporting OPTN committees and well as qualified personnel with doctoral level degree in statistics or related quantitative research fields?

Responses Requested

Please submit your responses by 10:00 AM ET June 26, 2020, to Veronica Dhaness at Vdhaness@hrsa.gov in the format below:

• Microsoft Word or Adobe 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.

mailto:Vdhaness@hrsa.gov

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• Submission shall not exceed 25 pages. Cover page is not include in the total page count.

Note: Language in any resultant solicitation will require all small businesses to recertify their size status at the submission of a quote or proposal. You are not required to respond to this sources sought notice if you cannot recertify your size as small.

Cover Page

Vendors shall include the following Business information on the Cover Page:

a) Sources Sought Notice number, title, and date of issuance

b) Data Universal Numbering System (DUNS)

c) Company Name

d) Company Address

e) Company Point of Contact, Phone and Email address

f) Validation of small business status under NAICS: 541611, Administrative Management and General Management Consulting Services, Size Standard $16.5M.

Additional information on NAICS codes can be found at www.sba.gov.

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The vendor is responsible for marking each page that contains proprietary data, however, vendors are hereby notified that information may be releasable under the Freedom of Information Act (FOIA). The Government reserves the right to use any submitted information in any resultant solicitation(s).

Disclaimer and Important Notes As stated above, this notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate.

Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess alternatives available for the potential requirement and may lead to the development of a solicitation. 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.

Respondents will not be notified of the results of this market research. Capability statements will not be returned, and will not be accepted after the due date for responses.

Teaming Arrangements Vendors seeking to respond to this notice as a team or to rely on subcontractors to perform any portion of the work must include the above-requested information and certifications for each entity on the proposed team or each proposed subcontractor. Responses must clearly indicate the nature of the teaming arrangement.

file://gss-fs1/shares/COO/OAMP/CAD/PP%20Samples%20FY17-FY19/Sample%2014%20-%20Sources%20Sought%20Sample/OGC%20Legal%20Review%20Revisions%202-20-2019/www.sba.gov

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The contractor and any subcontractors must not have any relationships or arrangements through business operations or its employees that could be considered as possibly lessening the company’s objectivity concerning any aspect of the proposed tasks. If such relationships or arrangements exist, contractors or subcontractors shall be required, during the procurement process (if one occurs), to identify potential conflicts of interest and discuss how the conflicts will be addressed and mitigated.

Attachment: Scientific Registry of Transplant Recipients (SRTR) Draft Performance Work Statement (PWS)