SAM #36C10X26Q0131

Sole Source Procurement: Codonics Safe Label Systems for VA Operating Room Medication Safety

This opportunity is a sole-source procurement by the Department of Veterans Affairs (VA) for Codonics Safe Label Systems (SLS) used in operating rooms, anesthesia locations, and pharmacies. - Sole-source contract awarded to Codonics, Inc. for Safe Label Printers and associated equipment - Products are FDA Class II medical devices for safe medication identification and labeling - Includes hardware, installation, licenses, clinical and technical training, software upgrades, technical service, and warranties - Printers must provide Joint Commission compliant labels and real-time safety checks using NEC2 codes - Contract duration is one 12-month base period plus four 12-month option years (total five years) - Estimated contract value is $60 million - Codonics is the only responsible source due to unique safety and operational requirements - No specific part numbers or quantities provided; interested parties may respond with their capability to meet the requirement

Description

This Notice of Intent to Sole Source is not a request for competitive quotations or proposals.

The Department of Veterans Affairs (VA), Enterprise Procurement Office (EPO), intends to negotiate and award a firm‑fixed‑price sole‑source Requirements contract, in accordance with Revolutionary Federal Acquisition Regulation (FAR) Overhual (RFO) 6.103‑1 for the procurement of Codonics® Safe Label Systems® (SLS) and associated equipment with Codonics®, Inc., 17991 Englewood Drive, Middleburg Heights, OH 44130.

The applicable North American Industry Classification System (NAICS) code is 339112, Surgical and Medical Instrument Manufacturing, is the most appropriate for this requirement. The size standard is 1,000 employees. The Product Service Code (PSC) is 6515, Medical and Surgical Instruments, Equipment, and Supplies.

The statutory authority permitting other than full and open competition is 41 U.S.C.3304(a)(1) as implemented by the Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) Subpart 6.103-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements”, as implemented by VAAR Part 806.

Interested parties may identify their interest and capability to meet this requirement. Any response must include sufficient detail to demonstrate the ability to provide all line items described below. No solicitation is available, and telephone requests will not be accepted.

Responses received will be reviewed; however, a determination by the Government not to compete this requirement is based upon responses to this notice is solely within the discretion of the Government. No cost to the government will arise as a result of contractor submissions of responses to this announcement or the government use of such information.

Requirement Description

The VA requires safe label printers for medication products for use in operating rooms (OR), anesthesia locations, and pharmacies. These products must support safe medication identification and administration during anesthesia care and meet clinical requirements unique to the perioperative environment, where medication errors present an immediate and significant risk to Veteran safety. Safe Label Printers for OR medications are the standard of care in hospital settings. Safe Label Printers for OR medications are U.S. Food and Drug Administration (FDA) Class II medical devices that improve the safety and accuracy of medication management and labeling compliance. Safe Label Printers are utilized in ORs with anesthesia drug carts to electronically identify the drugs. These printers use visual and audible confirmation based on the Numerical Electromagnetics Code 2 (NEC2) of the vial/ampoule provides the clinicians with real-time safety checks to eliminate medication errors. Safe Label Printers for OR medication system provide Joint Commission compliant labels. The main purpose of the system is to eliminate common drug errors and meet the Institute for Safe Medication Practices (ISMP) Guidelines for Safe Medication Use.

View original listing