36C24125Q0422.docx

SUBJECT*

Transducers : Anesthesiology Intent to Sole Source: SB OEM_Proprietary and Exclusive

GENERAL INFORMATION

SET-ASIDE

VAMC Togus

1 Veterans Center

Augusta, ME 04330-6719

USA

POSTAL CODE

COUNTRY

CONTACT INFORMATION

VA Connecticut 555 Willard Avenue Newington, CT 06111-2631

POINT OF CONTACT*

Contract Specialist Janice Jones Janice.Jones@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Presolicitation Notice Presolicitation Notice Intent to Sole Source_SB OEM Terason uSmart Transducers_Proprietary and Exclusive

Presolicitation Notice

INTENT TO SOLE SOURCE: PROCUREMENT OF TERASON USMART LINEAR AND CURVED ARRAY

ULTRASOUND TRANSDUCERS.

THIS IS NOTICE OF INTENT TO SOLE SOURCE FOR TERASON USMART LINEAR AND CURVED ARRAY

ULTRASOUND TRANSDUCERS: VAMC TOGUS, ME.

INTENT TO SOLE SOURCE FOR PURCHASE REQUISITION: This is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available, and telephone requests will not be honored.

The Department of Veterans Affairs VA Medical Center intends to award a one-time, Firm Fixed Price, Sole Source contract for the Terason uSmart Linear and Curved Array Ultrasound Transducers for VAMC Togus, ME.

This is to be a Name Brand Only Sole Source procurement from Small Business OEM Teratech Corporation. Togus has standardized to the Teratech uSmart ultrasound systems and transducers used in the Anesthesia Department. The OEM systems are unique and proprietary to the OEM and require the OEM brand transducers for compatibility. There are no third-party vendors available for the OEM’s products.

A Sole Source Letter has been provided by the OEM describing the proprietary nature of the uSmart Ultrasound Systems establishing this product as being peculiar to Teratech dba Terason. The letter states that only the OEM is authorized distribute this product domestically. Per Teratech, no other vendors in any class, aside from the OEM are authorized to distribute this product as a distributor or a reseller in the US.

The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901. This statute is implemented by for restricting competition on this procurement via FAR 8.405-6(a)(1)(i)(B).

The intent is to procure these services on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 334510: Electromedical and Electrotherapeutic Apparatus Manufacturing. The most current Business Size Rating for this NAICS is 1,250 employees.

Capable parties may identify their interests and authorization to respond to this requirement by 05/02/25 at 13:00 PM (EDT).

A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Contracting Officer.

Statement of Work (SOW) for Procurement of Transducers Department of Veterans Affairs Togus VA Medical Center, Augusta, Maine

1. Introduction This Statement of Work (SOW) outlines the requirements for the procurement of ultrasound transducers to support the Anesthesia Department at the Togus VA Medical Center. The requested Ultrasound Transducers will be utilized by anesthesia staff in the Operating Room to implement neural blockade (nerve block) techniques, contributing to improved postoperative pain management for veterans.

2. Background The Togus VA Medical Center is committed to providing high-quality healthcare to veterans, including pain management services. The use of ultrasound imaging for nerve blocks is crucial for enhancing procedural safety and accuracy. Currently, the facility operates three Ultrasound Machines, of which only two possess the necessary transducers for effective nerve block procedures. The procurement of the requested transducers will ensure all machines are equipped to provide optimal anesthesia care.

3. Scope of Work The contractor will provide the following ultrasound transducers as specified:

3.1 Deliverables

· Quantity and Description of Transducers:

1. Two (2) Units of 10-3378: 15L4A uSmart Linear Array Transducer

2. One (1) Unit of 10-3389: 16L5 uSmart Linear Array Transducer

3. One (1) Unit of 10-3278_R2: 5C2 uSmart Curved Array Transducer

3.2 Delivery Details

· Delivery Location:

Togus VA Medical Center 1 VA Center Augusta, Maine 04330

3.3 Payment Terms

· Payment as per the contract terms specified by the Department of Veterans Affairs.

4. Objectives The objectives of this procurement include:

· To equip all three Ultrasound Machines with the necessary transducers to support advanced anesthesia techniques.

· To ensure successful nerve block procedures that facilitate improved postoperative pain control.

· To minimize the risks associated with nerve injury, cannulation, and unsuccessful procedures.

· To enhance the ability of the anesthesia staff to visualize challenging anatomy based on different patient body habitus and improve overall procedural accuracy.

5. Quality Assurance

· The contractor must ensure compliance of all transducers with FDA regulations and relevant safety standards for medical devices.

· Necessary documentation, including warranties, product specifications, and user manuals, must be provided with the delivered equipment.

6. Performance Period The contractor must deliver all specified items within 45-60 days from the date of the signed purchase order.

7. Acceptance Criteria

· Upon delivery, the transducers will be inspected and tested by the anesthesia staff to confirm they meet the specifications outlined in the quotation.

· Acceptance will occur once all devices are verified for quality, functionality, and usability in clinical settings.

8. Conclusion This SOW formally represents the agreement between the Department of Veterans Affairs and the vendor, for the procurement of ultrasound transducers. It establishes the terms and conditions related to delivery, payment, and quality assurance, ensuring that the Anesthesia Department's needs are met effectively, thus supporting the delivery of high-quality care for veterans.

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C241-25-AP-2080

1. Contracting Activity: Department of Veterans Affairs, VISN 01, VA Maine Healthcare Systems, 1 VA Center, Augusta, Maine 04330.

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

VAMC Togus ME needs new Ultrasound Transducers that are compatible with and that will integrate with the Super Harmonics capabilities of the Terason USmart 3200 Ultrasound System already in place. The Super-Harmonics technology of the Terason USmart Linear Transducers is peculiar in that these transducers are the only transducers compatible with the Terason USmart 3200 Ultrasound. The array of Terason brand Linear Transducers enable Anesthesiologists and Nurse Anesthetists within enhanced imaging capability, allowing guide their usual diagnostic blocks with increased accuracy, due to the enriched detail afforced by the Terason U3200 System and its integrated Transducers.

The Smart 3300T Gen3 Ultrasound System is a portable imaging solution featuring Super-Harmonic imagining that enriched detail, clarity, contrast resolution, and border definition by utilizing the uSmart family of linear array and curved transducers. Some of features realized are Enhanced Needle Visualization (ENV), Dynamic Depth Resolution (DDR), Intima-Media Thickness (IMT), and TeraVision II which supports increase safety and accuracy while performing patient procedures. Increasing patient outcomes improves postoperative pain management and supports the VA Mission of providing high-quality healthcare.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: This acquisition requires four (4) state of the art, Terason brand Ultrasound Transducers for the VAMC Togus Anesthesia Department. VAMC Togus has standardized to the Terason Ultrasound System and currently possesses three (3) USmart 3300 Gen 3 Ultrasound System. To maintain the high standard of healthcare, VAMC Togus requires (4) additional Terason Transducers. These are the only transducers that will integrate with the USmart Ultrasounds and that are compatible with the Terason USmart Ultrasound System. The Terason Transducers are required to meet all fit, form, and function requirements for the Usmart 330 Gen 3 Utrasound System. The Terason USmart 3300 Gen 3 System sets the high standard of care at VAMC Togus and at many hospitals in the private sector.

The Terason uSmart 3300 Gen3 Ultrasound System possesses peculiar technological capabilities that market competitors do not have. The peculiarity of the Terason USmart Ultrasound System offers increased accuracy and precision in diagnostic imaging compared to other ultrasound systems in the market. The key distinguishing factor for the Terason USmart 3300 Gen 3 Ultrasound System is the "Super-Harmonic lmaging" capability of the treason Transducers. Terason Transducers are peculiar in their ability to provide crystal clear imaging. The combination of Terason’s proprietary charge-domain processing (CDP) beamformer technology and unique IIR signal processing produce an image with heightened clarity and definition.

Additionally, Terason’s "Enhanced Needle Visualization (ENV)." ENV is an evolved technology, providing clinicians better needle guidance at steeper angles without image degradation or a drop in frame rates. This increases patient safety and improves patient outcomes by reducing procedure time, by improving imaging and guidance accuracy.

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

Terason Transducers work with the USmart 3300 Gen 3 ultrasound systems to provide high-resolution ultrasound imaging for many precision procedures requiring high-resolution imaging. These Terason Transducers will enable clinicians to precisely place needles or other connected instruments to facilitate ultrasound interventions such as those required for anesthesia and biopsy procedures. The Terason technology affords quicker, more accurate imaging and diagnosis, which improves patient safety.

The high resolution provided by the Terason Ultrasound/Transducer System, enhances the ability of the anesthesiologists to see and to navigate challenging anatomies due to variations in patient body shapes, physiques, and builds. The increase in procedural accuracy enables clinicians to apply advanced anesthesia techniques. Additionally, improved resolution minimizes patient risk associated with nerve injury, cannulation, and unsuccessful procedures.

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

The customer conducted research prior to submitting the request to Contracting. The Terason uSmart Ultrasound System is standardized in many VA clinics across the nation. It is the preferred brand due to it peculiar characteristics not available among other brands. The uSmart systems Super Harmonic imaging capabilities, Enhanced Needle Visualization, and proprietary Charge Domain Processing technology, improves imaging and guidance accuracy resulting in improved safety and procedural outcomes for the Veteran patient population. Teratech, dba Tersason, is the sole manufacturer and the distribution of the product is proprietary and exclusive to the SB Original Equipment Manufacturer (OEM).

Contracting conducted additional Market Research IAW FAR 10.001 and VAAR 810.001. The market Research findings are recapped below:

Market Research Findings:

a. FAR 10.001: Traditional market research was conducted IAW FAR 10.001 and VAAR 810.001.

b. FAR 8.002 Mandatory Sources: Market research was expanded to identify other qualified vendor resources, according to the next level of precedence.

c. None of the mandatory sources listed below can supply the required uSmart Ultrasound Transducers.

i. Excess from VA Inventories: The VA does not maintain overstock for ultrasound transducers.

ii. Excess from Other Agencies: No other Government agencies stock Terason uSmart transducers.

iii. Federal Prison Industries (NA): FPI does not supply ultrasound transducers.

iv. Industries for the Blind (NA): The AbilityOne catalog was researched; the required transducers were not listed.

d. VAAR 810.001-70: Market research was conducted IAW VAAR 819.7005 and 819.7006. An NMR waiver exists for NAICS 334510 and includes medical ultrasound equipment. For this procurement, no NMR Waiver would be required due to the SB size of the OEM, as long as the other (3) prongs of the NMR are satisfied. Currently, there are no OEM authorized SD/VOSB distributors to afford set-aside competition.

e. VAAR 813-003-70(c): Market research was structured to identify and to offer fair opportunity for a VFCP application at “fair and reasonable” pricing. No SD/VOSB vendors are authorized by the SB OEM to distribute the uSmart Ultrasound Transducers. The Rule of 2 cannot be satisfied; there is no competition in the market; an SDVOSB set-aside cannot be applied.

f. FAR 8.004(a)(1) VAAR 808.004-70: There are no NAC, SAC or SEWP contracts carrying the uSmart Ultrasound Transducers.

g. FAR8.405-1 GSA Non-Mandatory Schedules: There are no ultrasound transducers on any GSA FFS or NAC FSS contract. The uSmart ultrasound transducers required are open market.

Nonmanufacturer Rule (NMR) Findings: The NMR Waiver List identifies NAICS 334510: Electromedical and Electrotherapeutic Apparatus Manufacturing as having a NMR Waiver. Per 72 FR (Federal Register) 72433, the NMR Waiver includes medical ultrasound equipment.

NMR (cont’d): The SB OEM has indicated that it has no authorized SDVOSB nor other SB class distributors. There are no OEM-authorized SDVOSB/SB class distributors. An SDVOSB set-aside cannot be applied; the Rule of 2(38 USC 8127(d)) cannot be met. Distribution is exclusive and proprietary, peculiar to the OEM. The OEM is uniquely capable of distributing uSmart Ultrasound Transducers.

Recommendation: The recommended strategy is for a single source award to the SB OEM Terason IAW FAR 13.106-1(b)(1)(i). Per a sole source letter from the SB OEM Terason, distribution of the Terason Transducer is proprietary, exclusive, and peculiar to the SB OEM. There is one manufacturer; one source of distribution on the market. There is an NMR Waiver for NAICS 334510 and the applicable FR. Even with a NMR Waiver, and even though the OEM is similarly situated, an SDVOSB Set-Aside cannot be applied; there are no OEM-authorized SDVOSB distributors. The SB OEM has stated the distribution of the product is proprietary and exclusive, peculiar to the SB OEM.

Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer VAMC White River Junction VT, NC01 RPOE Page 1 of