Sole Source Justification_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification >SAT-<$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 2 of 4

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

( ) International Agreement

(X) Authorized or Required by Statute ( ) National Security

( ) Public Interest

5. Demonstration that the C Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

In the mid-1980s, Congress made a commitment to patients with blood cancers, like leukemia and lymphoma, and other life-threatening diseases, when it established (authorized) a national bone marrow registry that patients and their doctors could search to find a bone marrow transplant. Since that time, Congress has consistently reauthorized what is now known as the C.W. Bill Young Cell Transplantation Program on a bipartisan basis every five years.

The Program supports patients who are in need of a bone marrow transplant through the creation of the national bone marrow and umbilical cord blood registry (known as the Be The Match Registry®), and the development of a grant program for public cord blood banks called the National Cord blood Inventory (NCBI). The NCBI helps fund the collection and maintenance of cord blood units used in bone marrow transplants. Also, a Research Advisory Council on Blood Stem Cell Transplant and the Stem Cell Therapeutic Outcomes Database was created, which supports research on improving the science of bone marrow and cord blood transplantation. Today, Be The Match operates the C.W. Bill Young Transplantation Program and is the global leader in providing cures to patients with life-threatening blood cancers such as leukemia and lymphoma, as well as other diseases. Through their registry of potential marrow donors and cord blood units. They also connect patients to their donor match for a lifesaving marrow or cord blood transplant, educate health care professionals, and conduct research so more lives can be saved.

In 2021, the 177th Congress passed Public Law 117-17, reauthorizing H.R.941/S.288, the TRANSPLANT Act, into law to renew the National Marrow Donor Registry Program through 2026.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

NMDP operates the federally-authorized program. As such, this requirement is authorized by statute and there are no other available sources.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

NMDP has an established Transplant Center Fee Schedule that is utilized for all Transplant Centers across the country. It is anticipated that the established rates will be fair and reasonable.

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification >SAT-<$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 3 of 4

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

The Market Research conducted was limited as this is a congressionally-authorized program with no viable competition.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

National Marrow Donor Program 500 North 5th Street Minneapolis, MN 55401

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

Due to the nature of the scope involving stem cells and blood, it is not anticipated this will be a viable competed action in the future. The current TRANSPLANT Act statute is valid until 2026, upon which renewal is likely.

12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer Network Contracting Office 9

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Branch Chief, Health Care Resources Network Contracting Office 9