SAM #36C26226P13891

Award for Custom Clinical Trial Healthcare Labels for VA Research Studies

This award notice details the Department of Veterans Affairs' contract with Citation Healthcare Labels LLC for custom clinical trial labels supporting two ongoing blinded studies. - Contract awarded to Citation Healthcare Labels LLC for custom opaque thermal transfer labels - Labels are uniquely designed for VA clinical trials CSP 2008 and CSP 2002 - Used with Zebra Industrial printers and specific software formats - Capture patient information, study numbers, and barcodes - Citation Healthcare Labels LLC is the sole manufacturer and distributor - Holds two patents for these specialized labels - Maintains a certified healthcare team dedicated to clinical trials - Market research confirmed no other vendors or OEMs can meet VA's regulatory and scientific requirements - Award amount is $50,000 - No competing OEMs or vendors identified - No service line items included; only product line items for custom labels

Description

Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID#

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1(b)(1) For Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold Acquisition Plan Action ID: _36C262-26-AP-6995

1.Contracting Activity: Department of Veterans affairs, Regional Procurement Office West (RPOW), Network contracting Office 22(NCO22), 4811 airport Plaza Drive, suite 600, Long Beach,CA 90815-as requested by the VA New Mexico Healthcare System.

Transaction Number: 501-26-4-137-0277

2.Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The research department is requesting a replenishment of Citation Healthcare Labels fortwo on-going blinded study clinical trials CSP 2008- Pentoxifylline in Diabetic Kidney Disease and CSP 2002- VA Impact . The 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 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 investigative levels of the studies.

3.Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The CSPCRPCC at this VA facility 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 include 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 for the continuance of the study. Purchasing labels from another vendor can skew scientific validity of the trial results and create bias. Clinical researchers require the trials to remain randomized; changes to the labels could disrupt study and increase costs to the Government. The vendor 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 via DSBS, the SAC, the NAC and Adds Up. A search for SAC did not render product information for the items listed in this request. The NAC listed a particular vendor, however additional research rendered that the labels are not the exact same items listed in this Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID# VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

request. ADDs Up revealed yearly purchases for Opaque Thermal Transfer labels were procured and awarded to the OEM, Citation Healthcare Labels. A review of SAM listed Citation Healthcare Labels LLC as a registered vendor and not listed on the Exclusion parties list.

1. Contracting Officer's Certification: Purchase is approved in accordance with FAR 13.106-1(b)(1). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ____________________________ ________________________ Name Contract Specialist ____________________________ ________________________ Name Contracting Officer Additional Links:Department of Veterans Affairs

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