7690--ALB_501_citation labels_501D50025

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Attachment 1: Single Source Justification for SAP under the SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1

For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: ___36C262-25-AP-5572

1. Contracting Activity: Department of Veterans Affairs, Regional Procurement Office West (RPOW), Network Contracting Office 22 (NCO-22), 4811 Airport Plaza Drive, Suite 600, Long Beach, CA 90815- as requested by the VA New Mexico healthcare System. Transaction Number: 501-25-4-337-0342 2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center is requesting a replenishment of Citation Labels for two on-going blinded study clinical trials - CSP Trial #2002 Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular Outcomes ; and CSP Trial #2008 Pentoxifylline in Diabetic Kidney Disease . The study requires the use of Veteran controlled groups to determine the effects of drug interactions in relation to the existing disease. As part of the on-going study across 40 VA Hospitals, the Citation Labels will be applied to specified bottles and distributed to study subjects. Each label will contain the necessary patient information, associated study number and barcode, all positioned on the designated panels to ensure proper identification and tracking. These items will also be used in conjunction with the Zebra Industrial printer and a predefined software printing format to continue transmitting essential data to test groups and laboratory personnel at all investigative levels of the studies. The purchase of the items will support the study by continuing to streamline the clinical trial overall and contribute to improved outcomes in Veteran patients. Estimated amount: $55,000.00 3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The CSPCRP Coordinating Center at VA New Mexico is currently using customized Citation labels affixed to test bottles that are shipped to patients. These labels have been specifically tailored to capture required information for two ongoing studies and to communicate individualized instructions to both controlled and uncontrolled test groups participating in the research. The use of uniform test labels across the cooperative study is necessary to maintain standardization, ensure consistent application of procedures, and preserve data accuracy throughout both clinical trials and across all participant groups. The items found in this requisition includes clinical labels previously purchased from Citation Healthcare Labels LLC, the manufacturer and sole distributor for these types of labels. The labels are uniquely designed to support and preserve the randomization required in the study. The vendor maintains a specialized and certified healthcare team that is solely dedicated to supporting clinical trials. This team is responsible for preparing and submitting all necessary documentation, including labeling required for use in VA Clinical trials. The VA must meet clinical regulatory compliance standards, and the use of this specific opaque label previously used supports proper documentation and traceability while meeting the required standard. Citation Healthcare Labels LLC is the only vendor capable of providing the labels needed to

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#:

replenish what has already been used for the above-mentioned clinical trials and no other vendor can supply the items to maintain the consistency of research protocols. Purchasing labels from another vendor can skew scientific validity of the trial results and create bias. Clinical researchers expectations are to continue keeping the trials randomized and any changes to the labels could result in changes to the program resulting in increased costs to the Government. Citation Healthcare LLC holds a longstanding customized proof for past VA requisitions for the items and holds two patents. This vendor can provide the supplies without delay and additional cost.

4.Description of market research conducted and results or statement why it was not conducted: Market research was conducted utilizing DSBS, GSA, VET Cert, FPDS and internet websites. A search of the NAC did not render information for this product. A search of the SAC did not yield a listing for this product. Further market research revealed that Citation Healthcare Labels, the manufacturer, is the sole provider and distributor for the customized labels and there are no distributors for the product. The vendor holds two patents with their labels which include Patent 5775735 and 5178419. This manufacturer is currently listed on SAM.gov and is also not listed on the Exclusion parties list.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.

Prepared by: Approved by:

_Rochelle Malveaux__________ Contract Specialist __Shavon Bogan_______ Contracting Officer