P03_Single Source Justification MPT to SAT mjc 1_Redacted.pdf

Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID# 36C241-26-AP-4068

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards For

Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C241-26-AP-4249

1. Contracting Activity: Department of Veterans Affairs, VISN 01, Boston VA Medical

Center, 1400 VFW Parkway, Boston, MA 02132

2237: 523-26-4-7077-0081

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Codonics Safe Label System (SLS) is a medication safety device that uses barcode technology to read vial and ampoules at the point of care. It provides visual and audible identification, which is key, of the drug in hand and, on demand, produces a Joint Commission-compliant label that includes a barcode for integration with the electronic health record (EHR). Codonics’ Safe Label System (SLS) is a medication safety device that uses barcode technology to read vial and ampoules at the point of care. SLS is an FDA-approved medical device that improves the safety and accuracy of medication management. It greatly reduces preventable medication errors anywhere medications are prepared such as the OR, ICU, PACU, patient floors, nurse medication prep stations and pharmacy.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Codonics’ Safe Label System is the only FDA Class II medical device designed to mitigate medication errors at preparation and administration. The unique serialized workflow provides multiple safety checks while saving time as compared to handwritten labels. This technology ensures compliance with Joint Commission and ISMP guidelines. Although there are several competitors in the point-of-care medication labeling systems in the marketplace, Codonics Safe Label System is the only one that has the audible alert of the drug name and concentration to verify medication that is required by VHA Directive 1195 for high alert medications.

Procurement and installation of this system will bring the Anesthesia Dept into compliance with that directive. Additionally, these products are the only safe

Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID# 36C241-26-AP-4068 labeling products which have been tested and validated for use and mounting on the current Omnicell Anesthesia WorkStations currently in use.

4. Description of market research conducted and results or statement why it was not conducted: SBA was searched with NAICS 339112 and keyword Codonics and no results were displayed. Sam.gov was then searched with 339112, 6515, and keyword Codonics and yielded zero results. GSA was also searched with item name and number with no results. SCMC and AddsUp were searched. SCMC resulted in no existing IDVs to utilize. AddsUp identified recent VA procurements with the OEM. A market research survey was sent to Codonics’ Direct Medical Account Rep. Sam Jablonski in which Codonics was identified as the sole manufacturer of this device and a sole source letter was provided and is on file.

5. Contracting Officer's Certification: Purchase is approved. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

MANASES CABRERA Digitally signed by MANASES CABRERA Date: 2026.08.06 07:17:04 -04'00'

17991 Englewood Drive Middleburg Heights, OH 44130

Friday July 31, 2026

Kim McCarthy Veterans Health Administration Regional Procurement Office East 940 Belmont Street (90C) Brockton, MA 02301-5596

Dear Kim;

Re: MANUFACTURER’S DECLARATION

Codonics Inc., with headquarters and production facilities (FDA Establishment Registration: 1530958, Owner Operator Number: 9026554) located at 17991 Englewood Drive Middleburg Heights, OH 44130 USA do hereby certify:

The Codonics Safe Label System SLS 550i and SLS 600i products are manufactured by Codonics Incorporated.

The SLS products are the only anesthesia safe labeling products which have been tested and validated for use and mounting on the Omnicell Anesthesia WorkStation.

If there are any questions on this matter, please contact me directly at (215) 947-4555 or email me at mgrabel@codonics.com.

Respectfully, Michael H. Grabel Director, Customer Services cc: Correspondence File