JA_OPTN Incorporation 5.2.2024.pdf

5600 Fishers Lane Rockville, MD 20857

Health Resources and Services Administration www.hrsa.gov

Sole Source Justification For

Acquisitions Conducted Under Simplified Acquisition Procedures

FAR 13.5

1. Identification of the agency and the contracting activity.

The Contracting Activity for this action is as follows:

Health Resources and Services Administration (HRSA) Office of Federal Assistance and Acquisitions Management (OFAAM) Office of Acquisitions Management and Policy (OAMP) 5600 Fishers Lane Rockville, Maryland 20857

2. Nature and/or description of the action being approved.

This is a sole-source action due to an urgent and compelling need to obtain all services necessary for the establishment of the Organ Procurement and Transplantation Network (OPTN) as an independent incorporated non-profit legal entity in a way that is consistent with National Organ Transplant Act (NOTA) and the OPTN Final Rule.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The required services include research on incorporation alternatives, drafting incorporation documents, process planning for incorporation, and providing all services necessary for incorporation of the OPTN.

The base period of the OPTN Incorporation Services is estimated at $875,600 and is required to be delivered by 6/20/2024. The optional task is estimated to cost $528,000 and the six-month extension is estimated to cost $960,000. The total estimated contract value is $2,845,924.00.

4. An identification of the statutory authority permitting other than full and open competition.

Health Resources and Services Administration www.hrsa.gov

The statutory authority permitting other than full and open competition is 41 U.S.C. 1901(e)(2)

– a sole source acquisition as implemented by FAR 13.501(a)(1)(ii).

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

As a result of internal changes to the corporate structure of the current servicing OPTN contractor, the OPTN Board of Directors was expected to lose its liability protection and insurance coverage at the end of March 2024. Without liability protection, the members of the Board indicated that they would resign and service and operations of the vital OPTN would quickly degrade, with no board of directors to address emerging and urgent issues or to direct or approve policy to ensure patient safety. As a result, serious injury would result to all members of the OPTN, the public, and transplantation patients. Based on market research, HRSA determined that prompt incorporation of the Board was needed to ensure continuing liability insurance protection to Board members, and thus the continued operation of the OPTN.

Therefore, HRSA determined that the most prudent way to address this issue is to take immediate action to establish an independent incorporated non-profit legal entity to carry out certain functions of the OPTN. Given the complexity of the issues involved with HRSA’s planned reformulation of OPTN operations, HRSA required the OPTN Incorporation Services contractor to have specific expertise and significant experience working with complex tax-exempt organizations and managing similar complex federal projects for government agencies or government-related entities.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

The proposed contract action is made under urgent and compelling needs as the government and the public would be seriously injured unless HRSA is authorized to sole source the contract immediately to continue the services. Therefore, insufficient time was available to publicize the contract action and exception 5.202 (a)(2) applies.

7. A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

Health Resources and Services Administration www.hrsa.gov

The Contracting Officer will use the independent government cost estimate for this effort to determine the anticipated cost to the Government of the services covered by this J&A to be fair and reasonable.

8. A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

Market research was conducted to identify capable small businesses, and based on market research conducted online, the subject vendor was identified as a small business with the capability, capacity, and experience necessary to complete the requirements of the solicitation.

9. Any other facts supporting the use of other than full and open competition, such as:

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

None.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

This is a one-time requirement, and no future similar acquisitions are anticipated. However, if a similar requirement arises, every effort will be made to compete it to the maximum extent practicable.