P03_NX EQ Safe Label Printers for OR Medications JA_FINAL_Redacted.pdf

Department Of Veterans Affairs Office of Acquisition, Logistics, and Construction

Enterprise Procurement Office 5202 Presidents Ct, Suite 103

Frederick, MD 21703

AS3-26-044

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

(1) Identification of the agency and the contracting activity, and specific identification of the document as a "Justification for Other Than Full and Open Competition."

This Justification and Approval for Other Than Full and Open Competition is executed by the Enterprise Procurement Office (EPO), on behalf of the Department of Veterans Affairs (VA), Veterans Health Administration (VHA) Equipment Life Cycle Management (ELCM) Program.

(2) Nature and/or description of the action being approved.

This activity proposes to negotiate a non-competitive Requirements contract with Firm Fixed Price (FFP) Delivery Orders to Codonics®, Inc. (UEI: DLVVVBZ7KNK9), an other than small business, for the procurement of the Codonics® Safe Label System® (SLS).

(3) A description of the supplies or services required to meet the agency’s needs (including the estimated value).

VHA 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. 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.

In addition to the Codonics® SLS, this action also includes installation, hardware, licenses, clinical training, technical training, technical service, software upgrades/releases, and warranties. The period of performance will be for one 12-month base period and four 12-month option periods. The Government estimated cost for this requirement is (inclusive of all options).

(4) An identification of the statutory authority permitting other than full and open competition.

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.”

(5) A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Over 85+ VHA facilities currently use the Codonics® SLS as their Safe Label Printer for OR medications, and any new Codonics® SLS purchase is simply an upgrade to the existing infrastructure. Replacing Codonics® SLS would require significant capital and time, making it impractical. Switching to a different vendor would burden facilities currently using the Codonics® systems, degrade OR operational flow and could compromise patient safety, as around 1,000 VHA employees, including clinicians and biomedical support specialists, would need to be trained on a new platform. Deploying an alternative system would require substantial time, effort, and investment, which is unacceptable for software that doesn’t meet the critical requirements mentioned below.

This contract will allow all VHA facilities to perpetually upgrade their existing Codonics® SLS to the latest software version.

The Codonics® SLS is also unique to VHA needs for the following technical reasons:

Patient Safety & Risk Mitigation Medication labeling risks in anesthesia practice, including misidentification, syringe swaps, and poor label legibility, represent real and material patient safety concerns in the operating room. Within VHA surgical settings, such errors may result in serious adverse events. As noted below, Codonics® SLS labeling solution is specifically designed to mitigate these risks, supporting VHA’s mission to provide safe, high-quality care to Veterans.

Unique / Differentiating Functions

• Barcode-based drug verification BEFORE labeling o Scans vial/ampoule and confirms drug identity with audible + visual confirmation o Prevents wrong-drug selection before it reaches the syringe; Handwritten stickers/tapes only provide labels, they do not verify the drug

• Standardized, rules-driven label generation (pharmacy-governed) o Uses a controlled drug library (formulary) with predefined concentrations, dilutions, and warnings o Enforces compliance automatically; Other systems rely on manual entry or static templates and handwriting that can be illegible or incomplete

• Automatic inclusion of safety-critical data o Drug name (with Tall Man lettering), concentration, diluent, prep time, expiration time, warnings (dilution/diluent) o Machine-readable barcode for downstream scanning which lead directly to greater accuracy and improved workflow

• Time-based safety (beyond-label awareness) o Tracks and prints beyond-use / expiration times o Supports awareness of expired syringes during workflow; This is not typically enforced by basic labeling tools or handwritten stickers/tapes

• Machine-readable labels enabling closed-loop safety o Labels can be scanned at administration (AIMS/EHR integration) o Enables documentation accuracy and secondary verification; Generic labels/stickers/tapes are not part of a closed-loop system

• Audible/visual confirmation during preparation and administration with Check-B4-

You-Inject option enabled o Real-time feedback reduces cognitive error under OR stress; These are a unique human factors safety layer

OR Environmental Suitability The operating room environment presents unique constraints, including sterility requirements, exposure to fluids, variable lighting, and time-critical workflows. These conditions materially differentiate OR medication labeling from general clinical labeling.

Codonics® SLS solution is engineered for sustained performance under OR conditions, whereas standard or generalized labeling products do not meet these environmental requirements. The Codonics® SLS is the only system that is compliant with VHA Directive 1195, High-Alert Medications.

Unique OR Operational Requirements

• Immediate labeling at point of preparation o Medications are drawn into syringes away from original packaging o 1. Scan, 2. Print, 3. Apply cadence of the Codonics® SLS improves safety

• Use with gloved hands o Labels must be easy to peel/apply with gloves

• Visually indistinguishable medications (clear liquids) o OR risk is dominated by syringe swaps—not packaging errors o 1. Scan, 2. Print, 3. Apply cadence of the Codonics® SLS along with audio/visual cues reduces these errors

• Dynamic preparation (dilutions) o Labels must reflect actual prepared concentration, not stock vial;

Codonics® SLS provides easy workflow for dilutions

Codonics® SLS uniquely addresses these OR needs

• Scan, Print, Apply cadence → instant safe workflow (in seconds)

• Minimal interaction design (low cognitive load)

• Preconfigured drug rules (ex: concentrations, warnings)

• Operable within anesthesia cart workflows

• Supports sterile-field proximity use

Functional Characteristics VHA clinical requirements necessitate labeling solutions with proven durability, legibility, and reliability throughout surgical procedures. Labels must remain intact and readable despite handling, moisture, and environmental stressors common in OR settings. These functional characteristics are clinically necessary to support safe anesthesia practice and are inherent to the Codonics® SLS product design. The Codonics® SLS is engineered specifically for OR stress conditions, not office or commercial environments:

Durability

• Labels are film-based (not paper)

• Labels are resistant to:

o Alcohol o Blood o Fluids o Handling and friction

• Label adhesive resists peeling/curling for ≥24 hours

Legibility

• Full-color, high-contrast printing

• Codonics® SLS supports:

o ASTM / ISO color coding standards o Tall Man lettering

• Print technology designed to prevent smearing or fading

Reliability

• Integrated printhead + cartridge system o Ensures consistent output from first to last label o Designed for the cold, dry environment of the OR

• High-volume cartridges reduce interruptions

• Designed for continuous OR use

Safety-enhancing reliability (beyond physical label)

• Eliminates handwriting variability

• Ensures consistent label format every time

• Reduces reliance on human memory and transcription

Workflow Integration Anesthesia medication labeling must integrate seamlessly into perioperative and anesthesia workflows without introducing additional steps, delays, or cognitive burden that could increase clinical risk. The Codonics® SLS solution aligns with established VHA anesthesia workflows, allowing clinicians to maintain focus on Veteran care while reducing the likelihood of medication errors.

Codonics® SLS is designed to replace unsafe manual steps, not add new ones.

How SLS operates in workflow Step-by-step (typical anesthesia use):

1. Clinician scans vial/ampoule

2. System confirms drug (audible/visual)

3. Label prints instantly (no typing)

4. Label applied to syringe

5. (Optional) Scan at administration for documentation + announcement of drug name/concentration and warnings

Why this does NOT add burden

• Replaces manual labeling step (already required by Joint Commission)

• Eliminates:

o Handwriting o Manual calculations o Label searching

• Reduces cognitive load via automation

Deep workflow integrations

• Anesthesia carts

• AIMS/EHR systems

• Hands-free scanning (SLS-WAVE option) for documentation

Pharmacy governance without workflow disruption

• Drug library managed centrally

• Clinicians do not configure or interpret rules

Key differentiator Codonics® SLS embeds safety into the existing moment of medication preparation —not as a separate task.

Clinical subject matter experts confirmed that no other manufacturer offers an anesthesia-specific medication labeling system that is compliant with VHA Directive 1195, High-Alert Medications, and that integrates patient safety, environmental durability, as well as workflow requirements as a single, validated solution.

While several other labeling solutions are used in ORs—including the Becton, Dickinson and Company (BD) Pyxis PharmoCode system, Omnicell Anesthesia Workstations equipped with integrated Epson syringe label printers, the Star Micronics TSP847IIRx secure medical printer, GoDEX DT2x/DT4x thermal label printers, and PDC Healthcare printers or preprinted sterile kits—none of these systems match the comprehensive safety capabilities of the Codonics® SLS. These alternatives lack real‑time drug verification at the point of draw through barcode scanning of vials or syringes, and they do not produce on‑demand, color‑coded, ISO 26825‑compliant syringe labels that include critical information such as drug concentration, diluent, preparation time, and expiration. They also do not provide audible or visual expiration alerts, nor do they support scan‑to‑admin workflows that verify the correct drug at the time of administration. Additionally, they lack integrated drug databases tightly linked to barcode-driven preparation workflows. As a result, although these systems can produce basic medication labels, they omit key safety layers—such as automated drug identity confirmation, dynamic expiration tracking, and end‑to‑end verification—that define the Codonics® SLS’s advanced medication safety design.

(6) A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

Market research, including clinical evaluation and review of available alternatives, indicates that other Safe Label Printers for OR medication solutions do not meet the combined patient safety, environmental, functional, and workflow integration requirements necessary for routine OR anesthesia use within VHA facilities.

There is no competition anticipated for this acquisition. The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed; however, all future requirements will be handled on a case-by-case basis to determine any future acquisition strategy. Section 8 of this document addresses the market research to support efforts made to solicit from others. This action will be published in accordance with RFO Part 5 to SAM.gov, Contracting Opportunities.

(7) A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

No award shall be made until the Contracting Officer determines the cost to the Government to be fair and reasonable. This determination will be based on a comparison of current contract pricing, an Independent Government Cost Estimate, past proposal submissions (if available), and other information as made available.

(8) A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

The first method used to conduct market research was to conduct a search for Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-Owned Small Businesses (SDVOSB) through https://veterans.certify.sba.gov/. A Small Business Administration (SBA) search was conducted using NAICS Code 339112 and the following key words: Printer, Safe Label. All keywords produced ZERO results for companies that offer the required items.

The second method used to conduct market research was to conduct research through current VA inventories and the world wide web to review manufacturers’ products to determine if they meet or exceed the brand name or equal salient characteristics for Safe Label Printers. Six manufacturer products were identified: 1.)

BD Pyxis PharmoCode system, 2.) Omnicell Anesthesia Workstations equipped with integrated Epson syringe label printers, 3.) Star Micronics TSP847IIRx secure medical printer, 4.) GoDEX DT2x/DT4x thermal label printers, and 5.) PDC Healthcare printers or preprinted sterile kits, however, none of these systems match the comprehensive safety capabilities of the 6.) Codonics® SLS.

In collaboration with the EPO, Contract Specialist, the third method used to conduct market research was to publish a Request for Information (RFI), Sources Sought Notice, to SAM.gov under RFI 36C10X26Q0035 on March 18, 2026. The RFI closed on April 6, 2026. The RFI resulted in responses from three vendors: 1.) Begini Howard Private Equity (BHPE), LLC, 2.) AI Advanced Solutions, LLC, and 3.) BD.

Each possible source was contacted by email and/or telephone to request authorized distributor letters from the Original Equipment Manufacturer (OEM). In addition, Codonics®, Inc. was contacted by email to request contact information for qualified sources able to provide the Codonics® SLS. Section 10 of this document addresses the results of review for each response to synopsis announcements.

Based on the market research conducted, there is not a reasonable expectation of adequate competition among small business manufacturers or adequate competition amongst other socio-economic concerns that are authorized distributors to warrant a set aside. Additionally, the market research shows the required supplies are available from only one responsible source and no other type of supplies will satisfy agency requirements.

(9) Any other facts supporting the use of other than full and open competition.

None.

(10) A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

1. BHPE, LLC, 10601 S Western Ave, Suite 113, Oklahoma City, OK 73170-6215.

(SDVOSB)

BHPE, LLC’s response to the Sources Sought Notice consisted of an automated email response and did not provide any product information.

2. AI Advanced Solutions, LLC, 401 Wellman St, Suite 100 Norfolk, VA 23502-4510.

(SDVOSB)

AI Advanced Solution’s response to the Sources Sought Notice included product information for the Codonics® SLS. On May 27, 2026, and June 2, 2026, the Contracting Officer sent an email to AI Advanced Solutions requesting a copy of their authorized distributor letter, however, the vendor did not reply to the requests.

3. BD, 3750 Torrey View Ct, San Diego, California, 92130. (Other than small business)

BD’s response to the Sources Sought Notice included product information and a “limited” authorized distributor letter for the Codonics® SLS. The included authorized distributor letter stated BD can sell the Codonics® SLS and all associated accessories; however, their distribution rights are limited to installations that are only in combination or attached to either an existing or new BD Pyxis Anesthesia System. This requirement is for standalone printers.

4. Codonics®, Inc., 17991 Englewood Drive, Middleburg Heights, OH 44130. (Other than small business)

On June 12, 2026, the Contracting Officer sent an email to a Codonics®, Inc.

representative requesting contact information of qualified sources able to provide Codonics® SLS. According to the representative, Codonics® SLS are not sold through distributors, but are sold directly to the VA from Codonics®, Inc. The representative further explained that Codonics®, Inc. has an OEM Supply Agreement with BD that allows BD to sell the Codonics® SLS with BD Anesthesia and Pharmacy automated dispensing products, and if there is a VA site that would like to purchase the Codonics® SLS, and they are also a BD CareFusion customer, BD CareFusion has the ability to also quote the VA. As previously mentioned, this requirement is for standalone printers.

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed; however, all future requirements will be handled on a case-by-case basis to determine any future acquisition strategy. Section 8 of this document addresses the market research to support efforts made to solicit from others.

(12) Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

David Hochheimer Date Project Manager Equipment Life Cycle Management

(13) Contracting Officer certification that the justification is accurate and complete to the best of the Contracting Officer’s knowledge and belief.

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Courtney Chattman Date Contracting Officer, Acquisition Service 3C Enterprise Procurement Office

Approval

In my role as Contracting Activity Competition Advocate, based on the foregoing justification, I hereby approve this acquisition on an “other than full and open competition” basis pursuant to the statutory authority cited in paragraph four above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition. As this action does not exceed $20M, the certification below required by RFO 6.104-2 serves as approval.

Efrain J. Fernandez Date Director, Contracting Operations Service Procuring Activity Advocate for Competition Enterprise Procurement Office