36C25026Q0622.docx

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

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office (NCO) 10 6150 Oak Tree Blvd., Suite 300

Independence OH 44131

POINT OF CONTACT*

CONTRACT SPECIALIST

Kevin Peeples Kevin.peeples@va.gov 216-487-1978

PLACE OF PERFORMANCE

10701 East Blvd

Cleveland OH

ADDITIONAL INFORMATION

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-01.

This solicitation is not a set-aside.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339113. The FSC/PSC is 6515.

The NCO 10 for Cleveland VA Medical Center is seeking to purchase the Arrow VPS Rhythm Navigation System for the Surgical Department. This solicitation closes on June 17, 2026 @ 4:00 PM. Quotes should be submitted to Kevin Peeples kevin.peeples@va.gov Please reference 36C25026Q0622

1. Contracting Officer’s Representative (COR

NA

2. Contract Title.

Cleveland VAMC -Purchase & Delivery of two (2) Arrow VPS Rhythm Navigation Systems for Antimicrobial Peripherally Inserted Central Catheters (PICCs).

3. Background.

The VA Northeast Ohio Healthcare System (VANEOHS) is requesting the purchase of two (2) replacement Arrow VPS Rhythm Navigation Systems for Antimicrobial Peripherally Inserted Central Catheters (PICCs). The current Arrow VPS devices are no longer economically viable to repair, and a loaner divide from the vendor is currently being used. The Arrow VPS Rhythm Navigation Systems are essential for the accurate placement of PICCs, which are crucial for patient care, especially in scenarios requiring long-term intravenous therapy. The devices currently in use by the Nursing IV Therapy team have exceeded their usable lifespan and have been deemed beyond economical repair. The accurate placement of PICCs is vital to prevent complications such as infection, thrombosis, and catheter malposition, significantly impacting patient outcomes. The units being requested are direct replacement for those being used.

4. Scope.

The purpose of this statement of work (SOW) is to outline the responsibilities and procedures for the purchase, delivery, configuration, testing, and clinical setup for two (2) Arrow VPS Rhythm Navigation Systems for the Nursing Service IV Therapy Team. These systems are essential for the accurate placement of Peripherally Inserted Central Catheters (PICCs) with antimicrobial features, crucial for patient safety and effective intravenous treatment.

5. Specific Tasks.

· 5.1: Product Acquisition

· Purchase of Arrow VPS Rhythm Devices (Quantity 2)

· Purchase of Arrow VPS Rhythm Device Accessories

· Purchase of Arrow VPS Rhythm Device extended Warranty

· 5.2: Delivery

· Vendor is responsible for packaging, shipping, and delivery of all items.

· Delivery shall include all necessary documentation, including operator’s manuals and instructions for use (IFU).

· 5.3: Device Configuration

· Vendor technical representative will unbox, assemble, and mount the two (2) devices onto the supplied mobile carts in the designated clinical areas.

· Vendor will configure device settings according to the Cleveland VAMC’s protocols, including but not limited to interface language and preferences, printer connectivity, catheter-to-vessel tool settings.

· 5.4: Testing & Setup

· Vendor will perform a full functional check of both systems (including integrated ultrasound and ECG tip confirmation features) in collaboration with the Cleveland VAMC’s Biomedical Engineering department.

· Verification of all accessories, inkling Tip Tracer T-Piece and ECG leads, will be performed to ensure they are in working order.

· Calibration check per the manufacturer’s guidelines will be completed.

· 5.5 Training and Support

· Initial In-Service Training – vendor will provide comprehensive in-service training for Nursing IV Therapy team and Biomedical personnel on the proper use, maintenance, and troubleshooting of VPS Rhythm DLX systems and accessories.

· On-going Support – Provision of contract information for Teleflex technical support and access to educational resources.

Deliverables:

· Delivery of physical equipment & accessories.

· Assembly of two (2) functional Teleflex Arrow VPS Rhythm DLX Systems will all specified accessories.

· Completed functional testing, installation, service, and support.

· Documentation & Training

· Training sessions for staff on the operation and maintenance of Arrow VPS Rhythm DLX Systems.

6. Performance Monitoring The assigned COR and Cleveland VA Medical Center facility IV Therapy Team will oversee all performance monitoring for this project. COR, Biomedical Engineering and Nursing IV Therapy staff will oversee the project ensuring timely completion and adherence to scope. Coordinate with the vendor and internal departments for smooth installation and implementation. Arrange training sessions for relevant staff on the use of the Arrow VPS Rhythm DLX systems.

7. Security Requirements The vendor will have no access to patient records, data, or VA computer systems. The vendor will be required to work with the Cleveland VA Biomedical Engineering Department to facilitate the integration of Arrow VPS Rhythm DLX systems with the existing infrastructure and clinical workflows.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

No GFE or GFI will be furnished to the vendor for this contract.

9. Other Pertinent Information or Special Considerations.

Vendor must have specialized experience with Teleflex Medical Arrow VPS products and have technological expertise for the original equipment manufacturers (OEM) robust line of products/accessories, technology and related services.

a. Identification of Possible Follow-on Work.

Possible follow-on work could encompass various aspects aimed at further enhancing the Arrow VPS Rhythm DLX systems utility, optimizing operational efficiency, and maintaining the longevity of the equipment. Possible follow-on could include but is not limited to system expansion/upgrades, software enhancements, advanced training, hardware upgrades, technical support and workflow optimization services.

b. Identification of Potential Conflicts of Interest (COI).

There are no known potential conflicts of interest with this request currently.

c. Identification of Non-Disclosure Requirements.

The contractor/vendor will not be working with any sensitive and/or proprietary information; therefore, the non-disclosure agreement is not required for this request.

d. Packaging, Packing and Shipping Instructions.

All items related to this project will be shipped to the Cleveland VAMC Warehouse located at 10701 East Blvd Cleveland, OH 44106.

e. Inspection and Acceptance Criteria.

The contracts assigned COR along with facility IV Therapy and Biomedical Engineering personnel will be responsible for inspection and acceptance criteria related to this project. Acceptance criteria will include:

· Successful installation and operational status of two (2) Arrow VPS Rhythm DLX systems.

· Integration with existing infrastructure without any technical issues.

· Completion of staff training and system testing with satisfactory results.

· Validation of system functionality for use in patient care settings.

10. Risk Control The requested project is only for the purchase, delivery, installation and implementation of equipment and would be considered low risk regarding patient safety and infection control. Potential risks are associated with this project but are not limited to delays in delivery, technical integration issues, staff training challenges.

11. Place of Performance.

VA Northeast Ohio Healthcare System (VANEOHS) Louis Stokes Cleveland VA Medical Center 10701 East Blvd Cleveland, OH 44106

12. Period of Performance.

The period of performance will be based on date/time of award. Cleveland VAMC staff and vendor personnel will coordinate the delivery schedule and project timeline after the award is fully executed.

CLAUSES

52.212-5

52.222-90

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS ALTERNATE II (JUL 2012)

ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS

JAN 2025

APR 2026

52.232-33

PAYMENT BY ELECTRONIC FUNDS TRANSFER – SYSTEM FOR AWARD MANAGEMENT

OCT 2018

852.219-76

852.203-70 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING-CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (DEVIATION)

COMMERCIAL ADVERTISING

JAN 2023

MAY 2018

PROVISIONS

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID:__ 36C250-26-AP-2889____________________

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Cleveland VA Medical Center is requesting Network Contracting Office to procure two (2) Teleflex Medical Arrow VPS Rhythm Navigation Systems for Peripherally Inserted Central Catheters.541-26-2-250-0222

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

The VA Northeast Ohio Healthcare System (VANEOHS) is requesting the purchase of two (2) replacement Arrow VPS Rhythm Navigation Systems for Antimicrobial Peripherally Inserted Central Catheters (PICCs). The current Arrow VPS devices are no longer economically viable to repair, and a loaner divide from the vendor is currently being used. The Arrow VPS Rhythm Navigation Systems are essential for the accurate placement of PICCs, which are crucial for patient care, especially in scenarios requiring long-term intravenous therapy. The devices currently in use by the Nursing IV Therapy team have exceeded their usable lifespan and have been deemed beyond economical repair. The accurate placement of PICCs is vital to prevent complications such as infection, thrombosis, and catheter malposition, significantly impacting patient outcomes. The units being requested are direct replacement for those being used.

· Product: Arrow VPS Rhythm DLX Navigation System w/accessories

· Estimated Cost: $19,602.00 per device

· Total Estimated Cost: $39,204.00 (2 devices)

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

Compared to competitors with similar devices, the Arrow VPS Rhythm device differentiates itself with an integrated ultrasound for high-quality imaging, a significantly larger visual field, unique electromagnetic navigation system that provides real-time visual of the catheter’s pathway and includes an on-screen troubleshooting feature. The Arrow VPS Rhythm system’s “TipTracker” technology is designed to eliminate the need for confirmatory chest x-rays, as its technology confirms central catheter placement. The device is also designed to be used with a wide variety of catheter types and sizes, requires no calibration before or during procedures, and has a light weight, portable design. The navigation system this product uses is a safety issue that prevents significant patient injury in PICC line insertion.

Based on the statutory authority found in the Federal Acquisition Regulation (FAR), contracting may use other than full and open competition when awarding to a Service-Disabled Veteran Owned Small Business (SDVOSB) when the procurement is under the simplified acquisition threshold. Teleflex Medical has two (2) partners that are able to fulfill this requirement for the Cleveland VA Medical Center (Marathon Medical and Alliant Healthcare).

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted to show two similar products: the BD Sherlock 3CG and the B. Braun Celsite PICC Cel. The BD Sherlock 3CG lacks an integrated ultrasound overlay which allows real-time viewing, an important safety feature that prevents injury and significant delays The B. Braun Celsite PICC‑Cel is not a navigation system and doesn’t support real-time tip confirmation or malposition reduction, which disqualifies that item. The Arrow VPS Rhythm DLX Navigation System w/accessories is preferred by the Cleveland VA Medical Center Nursing IV Therapy team, and it possesses the safety features necessary to prevent injury on PICC line insertions and demonstrates a higher than 98% first-attempt placement..

The medical device market for navigation systems used in placing central venous catheters (CVCs), including PICCs, is a dynamic and growing segment of the broader vascular access market. Driven by the need for enhanced patient safety, procedural efficiency, and the rising prevalence of chronic diseases requiring long-term IV therapy, these navigation systems offer advanced guidance for precise catheter tip placement, minimizing complications. Major medical device companies are actively competing and innovating in this space. Establish players like Teleflex Incorporated, Becton Dickson and Company, and B. Brain offer a wide range of vascular access devices and integrated navigation systems. Key competitors primarily differentiate their products through the integration of advanced technologies such as ECG, ultrasound, AI-enhanced visualization to improve accuracy, safety, and procedural efficiency.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR 13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

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