36C24123Q0704.docx

VA Connecticut Healthcare System Aquabeam Robotic System Statement of Work

GENERAL INFORMATION

VAMC Bedford

200 Springs Road Bedford MA 01730

POINT OF CONTACT*

Contracting Specialist Manasés Cabrera manases.cabrera@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract pursuant to 10 U.S.C 2304 (C)(1), as implemented by FAR 6.302-1(a)(2) and 6.301-1(c), only one responsible source and no other supplies or services will satisfy agency requirements, and brand-name descriptions.

The Department of Veterans Affairs Medical Centers located at 950 Campbell Ave, West Haven, CT 06516 have a requirement for a Procept Aquabeam Robotic System.

The Government intends to award a firm-fixed-price sole source contract.

A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. this notice of intent is not a request for competitive proposals. This is a written notice to inform the public of the Governments intent to award on a sole source basis.

Interested parties may identify their interest and capability to respond to the requirement. Any response to this notice must show clear and convincing evidence that competition will be advantageous to the Government.

Please contact Manasés Cabrera, Contracting Specialist with the responses or questions regarding this requirement at manases.cabrera@va.gov. No telephone calls please.

This notice will close on May 26, 2023, at 2:00 PM Eastern Standard Time (EST)

Special Notice Special Notice

Special Notice

Objective This document highlights the technical specifications and services being requested by the Connecticut VAMC for consideration towards the purchase for the Aquabeam Ablation Robotic System. Under this proposal the Vendor shall provide all equipment, accessories, applicable training, and manuals.

Project Management / Equipment Implementation Product delivery will be the responsibility of the Vendors working with the Connecticut VAMC project management POC, the Vendor will be responsible for coordinating and performing the delivery, implementation, and training for the devices.

Background/Justifications Aquablation therapy is delivered by the AQUABEAM Robotic system; the first FDA-Cleared Surgical Robot utilizing automated tissue resection for the treatment of lower urinary tract symptoms (LUTS) due to BPH. The unique design, coupled with robotic execution, allows for a decreased learning curve, shorter resection times and consistent, reproducible results; for patients and Urologists who want a better and safer option for treating lower urinary tract symptoms due to BPH. Aquablation therapy is a unique, next-generation BPH treatment that is removing the tradeoff between long-term symptom relief and irreversible side effects. Patients can get significant symptom relief with less risk of side effects that impact their quality of life, compared to the surgical alternatives like GreenLight, HoLep, and the gold standard TURP. Additional benefits are that it can treat almost all prostates of varying size, particularly those that are exceeding large where standard treatment can involve an open or laparoscopic surgical procedure, and with preservation of antegrade ejaculation in the majority of patients in whom this can be very important. This technology has already been incorporated into the urological practices of other VA hospitals such as the Buffalo VA and Los Angeles VA and is currently being considered for purchase at the Boston VA. In addition, at least one private hospital in the area (Middlesex Hospital) has purchased this system. It is currently accepted by the American Urological Association as a recognized successful surgical treatment for patients with BPH as indicated by its inclusion in the AUA guidelines for the surgical treatment of BPH.

Equipment Specifications System Equipment

a. Set-up monitors or modules [If applicable]

b. Software for Integration and Connectivity to Network (if applicable and desired)

c. Other

i. (2) User Manuals

ii. (2) Service Manuals

iii. (2) Reprocessing Manuals [If applicable]

iv. Information on disposable procurement

2. Services

a. Training

b. Installation [If applicable] Training Provided / Training Materials

1. Vendor will be required to provide two user manuals for the Aquabeam Ablation Robotic System will be required to provide two service manuals

2. Vendor will be required to provide an on-station in-service on the proper use and setup of the Aquabeam Ablation Robotic System.

3. Vendor will be required to provide the cleaning methods/guidelines for Aquabeam Ablation Robotic System and other accessories.

4. All employees who will be utilizing Aquabeam Ablation Robotic System., including Physicians/Surgeon, Technicians, Bio-Clinical Engineering, and Clinic staff members ("Trainees"), must be trained by an authorized representative from Alliant Healthcare Products prior to using the System.

5. No charge on a mutually agreeable date and time.

Records Management Language for Statement of Work (SOW):

The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

11. Contactor policies and procedures shall comply with all VA Privacy & Security, the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA).

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