36C24926Q0206.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 204 Murfreesboro TN 37129

POINT OF CONTACT*

Contract Specialist Daymeion Brantley daymeion.brantley@va.gov 615-225-3616

PLACE OF PERFORMANCE

800 Zorn Avenue

Louisville KY

ADDITIONAL INFORMATION

DESCRIPTION

This is not a request for quotes; the Government is seeking information for market research purposes only. VA Network Contracting Office (NCO) 9 is seeking sources interested and capable of providing the items as described in the attached Product Description.

The North American Industry Classification System (NAICS) is 339112 - Surgical and Medical Instrument Manufacturing

The Service Code (PSC) is 6515 - Medical and Surgical Instruments, Equipment, and Supplies

Responses to this notice shall include company/individual name, size status for the above reference NAICS code, a service capability statement, SAM Entity Unique Identifier (EUI), address, point of contact, and examples of similar facilities to which similar items have been provided.

Contractors must provide information on whether they are certified SDVOSB, VOSB, Hub zone, 8(a), women-owned concern. If standard company brochures will be provided as a response to this Source Sought ensure that additional information tailored to this notice is included.

This is not a solicitation for quotes. If a solicitation is issued, it will be announced on the Contract Opportunities website https: respond to that solicitation announcement separately from the response to this announcement.

Contractors must be registered in System for Award Management (SAM), see internet site:

https://www.sam.gov for information about registration.

Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each.

Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner?

If you are in GSA, please provide schedule and contract number.

Responses to this notice must be submitted via email to daymeion.brantley@va.gov. No telephone inquiries will be accepted.

DISCLAIMER This Sources Sought is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Sources Sought that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Sources Sought.

Veterans Affairs, NCO-9, is seeking information for vendors interested and capable of providing the service below:

Salient Characteristics

1. General Description • Medication syringe labeling system for anesthesia/OR use that scans the drug vial/ampoule barcode, audibly and visually confirms drug identity, and prints a color, TJC-compliant syringe label at the point of preparation.

• Integrated point-of-care station includes touch-screen computer, 2D barcode scanner, color inkjet label printer, audio feedback, and network capability.

2. Regulatory / Medical Device Requirements • FDA 510(k)-cleared Class II medical device for medication syringe labeling (Safe Label System).

• CE-marked medical device (MDR 2017/745/EU Class I) and manufactured under ISO 13485-compliant quality system.

• Must support TJC, ASTM, and ISO standards for medication syringe labels, including drug class–specific color and pattern per ASTM D4774 and ISO 26825 (or equivalent).

3. Core Functional Requirements • System must use barcode scanning of FDA NDC or equivalent drug container barcode to identify the medication and populate the label from a pharmacy-managed formulary.

• Provides on-screen text and audio confirmation of drug name and key attributes before printing, to mitigate vial/ampoule swaps and mislabeling errors.

• Prints water-resistant, full-color syringe labels including, at minimum: drug name, concentration, diluent and dilution (if applicable), expiration date and time, preparation date and time, preparer initials, applicable warnings, and a machine-readable barcode (1D and/or 2D).

• Pharmacy-driven formulary management with site-specific drugs, concentrations, diluents, and warnings, distributed to the device via SmartDrive USB and/or network connection.

• Must be capable of an “Administer” mode (or equivalent) in which the syringe label barcode can be scanned prior to administration to confirm contents and support documentation.

4. Printer / Label Requirements • Integrated color inkjet printer using a single CMY cartridge for syringe label media.

• Supports printing of ISO- and ASTM-conforming color fields, drug class color coding, and required text fields per syringe labeling standards and TJC recommendations.

• Produces durable, water-resistant labels suitable for OR/anesthesia use.

• Automatic label cutting with integrated label cutter; front-loading ink access and rear label-media loading.

5. Barcode and Data Requirements • Integrated 2D barcode scanner capable of reading at least the following symbology’s from drug containers and labels: GS1 DataBar (RSS) variants, GS1-128, and standard linear and 2D codes as published in manufacturer specifications.

• Prints 1D and/or 2D barcodes on syringe labels suitable for use with anesthesia information management systems (AIMS) and other hospital barcode systems.

• Must support capture and storage of log files, configuration, and formulary data via SmartDrive USB and/or network transfer.

6. User Interface and Controls • Integrated capacitive touch-screen display as primary user interface for workflow, prompts, and confirmations.

• On-screen status indicators, utilities, user login/initials, and date/time display.

• Audible prompts and tones, with volume control and mute capability, supporting confirmation and error notification.

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