P01 SOW 26AP0475.docx

STATEMENT OF WORK (SOW)

as of April 30, 2025 AIO 3.0 Base Plate SBRT Immobilization Systems

IFCAP Tracking Number:

Follow-on to Contract and Task Order Number:

1. CONTRACTNG OFFICER’S REPRESENTATIVE (COR)

Name:

Phone Number:

Fax Number:

E-Mail Address:

2. CONTRACT TITLE:

3. BACKGROUND

The VA Northeast Ohio Healthcare System (VANEOHS) Radiation Oncology Department requires the procurement of two (2) AIO 3.0 Base Plate Stereotactic Body Radiation Therapy (SBRT) Immobilization Systems (OR EQUIVALENT), along with their associated accessories, positioning supports, cushions, boards, and related components. These items will replace outdated immobilization platforms that have reached end-of-life (EOL) and are no longer supported by the manufacturer. The new systems and accessories will support high-precision immobilization during SBRT and other external beam radiotherapy treatments and ensure full compatibility with both CT simulation and TrueBeam treatment delivery systems.

The department currently relies on immobilization platforms that are no longer supported or serviceable, with limited availability of compatible accessories. These older systems are critical for procedures involving 4D respiratory simulation and stereotactic body radiation therapy (SBRT) but have become a limiting factor in clinical care due to discontinued parts and incompatibility with modern accessories.

This procurement will allow the department to standardize and upgrade its immobilization workflow using the AIO 3.0 system (OR EQUIVALENT), restoring access to a full suite of manufacturer-approved supports and positioning tools, and enabling reproducible, high-precision treatment delivery.

4. SCOPE

The Radiation Oncology Department is requesting two (2) AIO 3.0 Base Plate SBRT Immobilization Systems (OR EQUIVALENT), along with their associated accessories, positioning supports, cushions, boards, and related components. This request is being entered as a brand name requirement restoring access to a full suite of manufacturer-approved supports and positioning tools, and enabling reproducible, high-precision treatment delivery in alignment with current clinical applications and workflows.

· All components must be fully interoperable with:

· Varian TrueBeam treatment couches (OR EQUIVALENT)

· CT simulator couch tops

· Department’s existing radiotherapy planning and delivery workflows

· Accessories must be designed to function as part of a unified SBRT positioning system (OR EQUIVALENT)

The ability to immobilize patients accurately is fundamental to modern radiation oncology, especially for high-dose-per-fraction regimens such as SBRT. The acquisition of AIO 3.0 systems and accessories (OR EQUIVALENT) will:

· Replace outdated and unsupported immobilization equipment

· Restore full functionality and access to clinically essential accessories

· Improve setup consistency, accuracy, and patient comfort

· Reduce treatment errors and improve safety through standardized patient positioning Maintain compliance with department protocols and national guidelines.

5. SPECIFIC TASKS

The Contractor shall provide two (2) AIO 3.0 Base Plate SBRT Immobilization Systems (OR EQUIVALENT), along with their associated accessories, positioning supports, cushions, boards, and related components. The requested systems and accessories are listed below:

compatible without leg separator with shim (OR EQUIVALENT) 2 piece(s)

Grey cushion set(OR EQUIVALENT) 2 piece(s)

base plate (OR EQUIVALENT) 4 piece(s)

AIO 3.0 Loxon Set for 53cm base plate for Exact couch (MR safe) (set of 2) (OR EQUIVALENT) 4 piece(s)

The AIO 3.0 Base Plate SBRT System is a modern immobilization platform engineered for use in stereotactic body radiation therapy and high-precision external beam radiotherapy. It ensures consistent, reproducible, and secure supine patient positioning, allowing treatment teams to minimize motion and achieve optimal alignment during both simulation and treatment.

A. Compatibility and Integration

· Directly attaches to:

· 4D-capable CT simulator couches

· Varian TrueBeam treatment couches (OR EQUIVALENT)

· Supports motion-managed respiratory workflows (4D CT simulation and gated treatment)

· Designed for seamless patient transfer between imaging and treatment systems B. Clinical Functionality

· Enables secure positioning for:

· Thoracic, abdominal, spinal, and pelvic sites

· Modular configuration allows clinicians to adapt setups for individual patient needs

· Works in tandem with custom-fitted accessories for immobilization D. Interoperability

· All components must be fully interoperable with:

· Varian TrueBeam treatment couches (OR EQUIVALENT)

· CT simulator couch tops

· Department’s existing radiotherapy planning and delivery workflows

· Accessories must be designed to function as part of a unified SBRT positioning system E. Durability and Quality

· All components made from radiolucent, disinfectant-resistant materials

· Carbon fiber or equivalent structure ensures minimal imaging artifact and beam interference

· High-grade construction suitable for continuous clinical throughput

6. Performance Monitoring

The COR will verify that the equipment is delivered in accordance with the contract and listed deliverables. The COR will ensure that all deliverables are acceptable for use and application and proper form, fit, and function.

7. Security Requirements

The C&A requirements do not apply, and the Security Accreditation package is not required for this SOW.

This is a equipment delivery without installation services.

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

There will be no government-Furnished equipment of information.

9. Other Pertinent Information or Special Considerations.

The requested equipment shall be interoperable/usable with current workflows and technology deployed and used within the clinical atmosphere.

a. Identification of Possible Follow-on Work.

NA

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

NA

c. Identification of Non-Disclosure Requirements.

NA

d. Packaging, Packing and Shipping Instructions.

NA

e. Inspection and Acceptance Criteria.

10. Place of Performance.

VANEOHS

10701 East Boulevard Cleveland, Ohio 44106

11. Period of Performance.

NA

12. Delivery Schedule.