P09 Rezum SOW May 30 2025.pdf

El Paso Veterans Affairs Health Care System (ELPVAHCS) Rezum Water Vapor Therapy

Statement of Work (SOW)

The Department of Veterans Affairs, El Paso VA Health Care System (EPVAHCS), has a requirement for Rezum Water Vapor Therapy for the treatment of prostatic hyperplasia to provide a new urological minimally invasive procedure in ASU. The Contractor must provide all labor, material, tools, management, travel, and equipment necessary to supply, install and provide support services to El Paso VA Medical Center. in accordance with the specifications of the Statement of Work as stated below:

SPECIFICATIONS/SALIENT CHARATERISTICS

Salient Characteristics

The Rezum Water Therapy System consists of several key components, including the power source generator, the delivery device (attachment), and the connecting cable.

Here’s a more detailed explanation of each:

1. Power Source Generator: The power source generator is responsible for converting electrical energy into thermal energy. It uses radiofrequency (RF) energy to heat water, which is then converted into steam. Typically, it operates at a specific voltage and current to ensure safe and effective steam generation. The generator is equipped with safety features to monitor and control the temperature and pressure of the steam. It may also include a user interface for healthcare providers to set treatment parameters and monitor the procedure in real-time.

Overall, the power source generator, delivery device, and connecting cable work together seamlessly to provide a safe and effective treatment for Benign Prostatic Hyperplasia (BPH). The generator produces steam, which is delivered through the cable to the delivery device, allowing for targeted treatment of the prostate tissue. The entire system is designed to meet regulatory standards for medical devices, ensuring safety and efficacy during use. Regular maintenance and checks are typically required to ensure the equipment operates correctly and safely. For specific technical specifications, it is advisable to refer to the manufacturer's documentation or product manuals, as these can provide detailed information on the power source generator's output, the delivery device's dimensions, and the cable's specifications.

a. Common Nomenclature (commercial description):

Rezum rapid heat generator therapeutic device heat delivery system

b. Kind of material (i.e., type, grade, alternatives, etc.):

Biocompatible, durable, and capable of withstanding high temperature medical grade plastic, stainless steel, ceramics, silicone and other elastomers

c. Electrical Data (i.e., 110 v, 60 Hz, 3 Ph, etc.): 100-240 V

d. Dimensions, size, capacity: 1. Dimensions:

Height:

Approximately 30- 40 cm (12-16 inches) Width:

Approximately 25- 35 cm (10-14 inches) Depth:

Approximately 20- 30 cm (8-12 inches)

Weight: Approximately 5-10 kg (11-22 lbs)

e. Principles of operation: The Rezum system operates on the principle of thermal ablation using radiofrequency (RF) energy to convert sterile water into vapor. It contains a water reservoir that holds sterile water for vapor generation. The device generates RF energy, which is converted into thermal energy to heat the water, resulting in vaporization at approximately 103°C (217°F). This vapor is then delivered via a catheter into the prostate tissue. Upon contact with the tissue, the vapor expands, causing localized thermal injury and ablation of excess prostate tissue. The system allows for precise dosing to minimize damage to surrounding healthy tissue. The procedure results in a reduction of prostate size and alleviation of symptoms associated with benign prostatic hyperplasia (BPH). This minimally invasive procedure typically lasts 10-15 minutes and is performed in an outpatient setting.

f. Restrictive environmental conditions: Work on operating systems (like Windows, macOS) or with certain web browsers (like Chrome, Firefox, Safari), keep dust, salt, sulfur, flames free, keep off X-ray rooms

g. Intended use: Powered by convective water vapor energy, the Rezūm System delivers targeted, controlled doses of the stored thermal energy in water vapor directly to the region of the prostate gland with the obstructive tissue causing the lower urinary tract symptoms (LUTS) such as urinary retention secondary to benign prostatic hyperplasia (BPH).

h. Equipment with which the item is used with (N/A if not applicable):

Delivery Device (Attachment): The delivery device is a sterile, single-use instrument that is inserted into the urethra to deliver steam directly to the prostate tissue. The design includes a steam emitter at the end of the delivery device that releases the steam in a controlled manner.

i. End item application: It uses radiofrequency (RF) energy to heat water, which is then converted into steam. Typically, it operates at a specific voltage and current to ensure safe and effective steam generation. The generator is equipped with safety features to monitor and control the temperature and pressure of the steam.

It may also include a user interface for healthcare providers to set treatment parameters and monitor the procedure in real-time.

j. Original equipment manufacturer part number:

BSC D2201-5SB

k. Other pertinent information that describes the item, material or service required:

The Rezūm system is a minimally invasive treatment for Benign Prostatic Hyperplasia (BPH), also known as an enlarged prostate, which utilizes the thermal energy of water vapor to shrink the enlarged areas of the prostate,and relieves urinary symptoms such as frequency, urgency, and urinary retention.

1.0 DESCRIPTION OF SERVICES

The Contractor shall provide technical support services to connect to current and future upgrades of PPS workstation and telephone support for all applications.

Equipment Support shall be provided during the warranty period.

1.1 Software Applications

The Contractor will provide and update all software applications, as they become available, through usual commercial channels. The Contractor will make recommendations for application upgrades. “Software” means the application software and license to the Customer by the original software developer.

“Customer” means the site of the firm, group, company, or corporation.

1.2 Software Support Services

The Contractor must provide unlimited telephone and email support to Customer inquiries regarding the use and operation of the software. This does not include training in the use of the software, customer modifications, product development, or modification of existing source codes belonging to the Government.

Software fixes, patches, and free software updates must be made available through the duration of the contract.

1.3 Troubleshooting and Repair

Any problems with the system must be isolated and repaired by the Contractor.

The Contractor will trouble shoot the hardware, software, and communications equipment to determine the best method of repair. If problems are found, the Contractor shall contact the appropriate and authorized maintenance organization or company and track the trouble call until it is resolved.

1.4 Contractor Responsibilities

During the term of this contract, the Contractor will provide support at the Customers request and will use its best efforts to provide prompt software support services to the Customer by telephone. The Contractor will provide telephone support to Customers between the hours of 8:00 am and 5:00 pm Central time, Monday through Friday, excluding holidays recognized by the VA.

The Contractor will use its best efforts to respond promptly to all inquiries by the customer within one (1) hour of notification that service is required.

2.0 GENERAL INFORMATION

2.1 Hours of Operation

Normal hours of operation are Monday through Friday from 8:00 am to 5:00 pm CST, excluding holidays. All services shall be performed during normal hours of coverage unless requested and approved by the COR. Due to the nature of the project, the Contractor understands that a portion of the work will be performed in [patient] occupied areas. Therefore, work shall be performed in strict accordance with the Conformance Standards and OSHA regulations. Contractor shall perform work in a professional manner and shall minimize the disruption of normal operations of the facility including the occupied patient and staff areas.

Federal and National Holidays observed by the VAMC are:

National Holidays Federal Holidays

New Year's Day Labor Day Memorial Day

Thanksgiving Day Christmas Day

M L King's Birthday Columbus Day President's Day Veterans Day Independence Day Juneteenth

Also included would be any other day specifically declared by the President of the United States to be a National Holiday.

When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday.

3.0 FACILITY POINT OF CONTACT

POC: Alicia Hernandez, Nurse Manager ASU, EPVAHCS Phone: (915) 564-6100 Ext. 7937 Email: alicia.hernandez1@va.gov

The Contractor’s employees must wear visible identification and company uniforms, approved by the COR, at all times while on the premises of the VAMC.

It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section or the COR. The VAMC will not invalidate or make reimbursement for any parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, must be subject to a search. Violations of VA regulations may result in citations answerable in the United States (Federal) District court, not a local district, state, or municipal court.

5.0 INFORMATION SYSTEMS OFFICER, INFORMATION PROTECTION:

The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

6.0 Privacy Officer:

The contractor will not have access to Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA.

7.0 NARA Records Management Language for Contracts

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. El Paso Veteran Affairs Health Care System (EPVAHCS) and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of EPVAHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to EPVAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to EPVAHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and EPVAHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with EPVAHCS policy.

8. The Contractor shall not create or maintain any records containing any non-public EPVAHCS information that are not specifically tied to or authorized by the contract.

9. The 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 from public disclosure by an exemption to the Freedom of Information Act.

10. The EPVAHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which EPVAHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

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