_PWS.pdf

Performance Work Statement (PWS)

High-Intensity Focused Ultrasound (HIFU) System for

Southeast Louisiana Veterans Health Care System New Orleans, LA

1. PURPOSE: The overall purpose is to offer High-Intensity Focused Ultrasound (HIFU) that provides non-invasive treatment and service support for prostate cancer treatment. The place of performance shall be delivered to the Southeast Louisiana Veterans Health Care System (SLVHCS), Diagnostics and Treatment Building within Surgery Service, 2400 Canal St, New Orleans, LA 70119.

2. SCOPE:

2.1 The contractor shall provide on an as-needed basis a High-Intensity Focused Ultrasound (HIFU)

HIFU system that enables SLVHCS to offer treatment options for patients under direct medical care within Urology surgical service. HIFU is a non-invasive procedure that allows the surgeon to heat and destroy specifically targeted tissue areas using ultrasonic energy, or sound waves. With HIFU, physicians have the ability to target and treat a small amount of tissue, which minimizes damage to areas around the prostate. The treatment helps prevent normal urinary function and minimizes the risk of erectile dysfunction.

2.2 The contractor shall be available to cover scheduled cases Monday through Friday from 0630 to

1800. Due to the surgical complexity, the contractor shall have experience providing the HIFU equipment listed in this PWS. The contractor will be on-site 1 hour before the surgery for procedures and notification. The vendor shall be available from 0630 to 1800 for routine and scheduled cases.

2.3 The contractor shall provide a list of medical equipment that will be utilized for each live surgical procedure.

2.4 If necessary, The contractor shall participate in the simulations (mock surgical procedures).

2.5 The contractor shall provide in-person training for sterile setup and procedure flow for the operating room staff, including surgical technicians and nurses, and must provide training materials for operating room staff.

2.6 Thee contractor shall provide the HIFU system that includes but is not limited to the following:

Sonasource Console, Sonachill, and Sonablate Probes

2.6.1 The contractor shall pay all shipping and handling fees for equipment.

2.6.2 The contractor shall package the HIFU system in such a manner as to ensure its integrity during transport.

2.7 The contractor shall be responsible for providing a surgical system that can function with the current power (electrical) supply, 110 Volts.

2.8 The contractor shall provide the most recent technology.

2.9 Contract must provide a 24-hour/7 days accessible toll-free number.

2.10 The contractor is responsible for arriving one hour before the scheduled procedure. The contractor shall set up all equipment and advise the surgical team on the proper sterile setup for the procedure.

The contractor is also responsible for cleaning, storing, and transporting all medical equipment listed in section 3.0, salient characteristics.

3.0 SALIENT CHARACTERISTICS:

3.1 Sonablate HIFU systems equipment/ Technician and mobilization fee include but are not limited to

Sonasource Console, Sonachill, and Sonablate Probes.

Part # Description

102-17000-

• Sonasource Console

102-17000-

• Sonablate Chiller

• Must be able to recirculate and cool distilled water.

• Must contain a vacuum pump, air trap, and vacuum gauge.

• Must have the ability to remove air bubbles

• Must have the ability to monitor freezing from liquid to air by heat exchange.

202-17000-

• Sonablate Probe

• Must be at least 3.3 cm in Diameter

• Must be able to deliver high-intensity ultrasonic HIFU pulses

• Must have two custom piezoelectric transducers

• Must have water ports

• Must include an articulating arm probe

4.0 DELIVERY: The contractor shall provide COR with a point of contact to establish and communicate requests from the government for delivery.

4.1 Delivery of HIFU equipment will be coordinated with the COR

a. Contractor must check-in with the COR

b. Contractor must remove and dispose of all packaging trash, including crates, from the facility.

4.2 The HIFU system will be selected from any items in section 9, Deliverables, for the duration of the contract. All equipment must be inspected by the facility’s Biomed department and tagged by the logistics department.

4.4. Contractor shall deliver all equipment regarding the HIFU system to the Southeast

Louisiana Veterans Health Care System (SLVHCS) Diagnostics and Treatment Building within

Surgery Service at 2400 Canal St, New Orleans, LA 70119.

5.0 SITE CONDITIONS: There shall be no smoking, eating, or drinking inside the hospital at any time.

6.0. INSPECTION AND ACCEPTANCE: The COR shall ensure all items are satisfactory prior to acceptance. COR will issue a Contract Deficiency Report (CDR) for products and actions not in accordance with the contract. The Contracting Officer shall resolve disputes.

7. DELIVERY/STORAGE REQUIREMENTS: Delivery and request will be coordinated through the COR.

8. Installation is not required. The medical device will be delivered for all scheduled surgical procedures.

9. DELIVERABLES:

Item # Description Quantity Unit of Measure

001 • Sonablate Rental Fee includes Sonablate

Console (part #: 102-17000-

• 0009), Sonablate Chiller (part #: 102-17000-

0007), and Sonablate Probes (part #: 202-

17000-0012) Visual Ice HIFU System

30 cases a year

Procedure

002 • Technician & Mobilization Fee Technician Fee includes Equipment Mobilization Fee, Technician for Procedure, and any associated travel cost.

30 cases a year

Procedure

IMAGE: HIFU System

10. Invoicing and Payment:

a. Invoices shall be submitted in arrears after completion of delivery.

b. The vendor shall provide an acceptable VA itemized bill for all items shipped for payment with each shipment.

c. All Invoices from the contractor shall be submitted electronically in accordance with

VAAR Clause 852.232-72 Electronic Submission of Payment Requests. VA’s Electronic

Invoice Presentation and Payment System – The FSC uses a third-party contractor, Tungsten, for vendor electronic invoice submission methods. Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below: VA’s Electronic Invoice Presentment and

Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission.

Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site

(http://www.x12.org).

d. An itemized invoice shall be submitted to the COR for all deliveries made during a billing period and for which payment has not been received. Copies of delivery tickets shall support these invoices. "Approved-for-payment" invoices will be submitted to the payment address specified on each individual order issued under this BPA.

11. Federal Observed Holidays:

11.1 Federal Holidays observed by the Government are: New Year’s Day, Martin Luther

King’s Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus

Day, Veteran’s Day, Thanksgiving, and Christmas, along with any other day specifically declared by the President of the United States to be a national holiday. In addition to the days designated as holidays, the Government observes the following days:

• Any other day designated by Federal Statute

• Any other day designated by Executive Order

• Any other day designated by Presidential Proclamation http://www.tungsten-network.com/US/en/veterans-affairs/

12. SECURITY REQUIREMENTS: Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA

Directives and Handbooks as VA and VA personnel regarding information and information system security.