P03 Single Source Justification_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID#: 36C262-25-AP-1038 accurate identification of the sentinel node on the nuclear medicine scan. The location of this node is communicated to the surgeon, who will be able to find it during surgery the following day. Unlike Lymphoseek, other agents (such as filtered sulfur colloid) separate from the receptor. These agents have a mechanism of action based on particle size and phagocytosis (gathering large particles by lymphatics) which is less effective. Lymphoseek has its superior ability of targeting the active receptor and allows the drug to stay in only that receptor and the radioactivity to fade away.

Lymphoseek provides the most superior image quality localizing involved lymph nodes in patients.

Cardinal Health 414, LLC is the only responsible source for the required Lymphoseek that is highly specialized. Any substitute of this radioactive drug will directly affect patient cares at VA Long Beach Healthcare System. Cardinal Health 414, LLC is a patent right to manufacture and distribute Lymphoseek, which makes them the only responsible source. The company has successfully delivered and completed similar requirements at multiple VISN 22 VA Medical Centers in the past.

This requirement can be only fulfilled by Cardinal Health 414, LLC; refer to the proprietary and authorized distributor letter uploaded to eCMS briefcase as P03.

4. Description of market research conducted and results or statement why it was not conducted:

Small Business Administration (SBA)’s VetCert was utilized to identify potential SD/VOSBs, and it returned 133 SD/VOSBs registered under NAICS code 325412. However, identified SD/VOSBs did not have capabilities to manufacture nor distribute Lymphoseek as Lymphoseek is a proprietary radiopharmaceutical injection. Similar past procurements’ market research and its procurement method were reviewed. Past award# was made to Cardinal Health 414, LLC for VA Long Beach’s FY24 requirement on Lymphoseek using other than full and open competition procedure due to Lymphoseek being a proprietary item. Another recent award, IDIQ contract#

, was awarded to Cardinal Health 414, LLC for VA Loma Linda Nuclear Medicine’s requirement on Lymphoseek, which was also used other than full and open competition IAW FAR 6.302-1 since Cardinal Health 414, LLC is the only provider of Lymphoseek. The special notice, an intent to sole source, was posted on SAM.gov for the IDIQ; however, there were no other contractors capable to fulfill the requirement. VA National Acquisition Center Pharmaceutical Catalog was utilized to see if Lymphoseek is available through an existing VA NAC FSS contract, but it was not available under the VA NAC.

Cardinal Health 414, LLC confirmed and provided a letter indicating that they have exclusive rights to manufacture and distribute Lymphoseek in the United States. The Contracting Office has verified and confirmed that Cardinal Health 414, LLC indeed holds exclusive rights to manufacture and commercialize Lymphoseek via online search engines.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

NCO 22