SOW- fy 25.pdf

STATEMENT OF WORK (SOW)

Providence VA Medical Center (650)

RENTAL OF SHOCK WAVE

LITHOTRIPSY

1. BACKGROUND:

A. This is a non‐personal services firm fixed price purchase order continuous rentals of lithotripsy treatments and renal laser equipment services. This service contract is to be used in the practice of urology for eligible VA patients at the Providence VA Medical Center, (PVAMC) Providence, Rhode Island.

B. The Contractor shall provide all necessary licensed and credentialed technician(s), supervision, labor, equipment, materials and disposal of necessary for our urology services.

C. The Contractor will further provide component chips/fibers and any other necessary supplies, attachments, or equipment as needed and/or listed in the Quantity and Fees section.

D. Obligated funds for any type of rental, supplies, equipment, etc. requested by the PVAMC but not utilized at the end of each annual contract shall be de‐obligated.

2. OBJECTIVE:

A. With respect to the lithotripsy machine, an overview of this SOW will include need, goals and objectives the PVAMC has for the continuously rental of the mobile lithotripsy machine.

B. The minimum day charge applies when the contractor makes timely delivery of the laser system to the PVAMC site on a scheduled day.

C. If a laser system is delivered to the PVAMC site and is inoperable for 60 minutes or more with the result that the designated surgeon must postpone surgical procedures the contractor will forego all charges for that surgical procedure.

3. SCOPE:

A. The contractor’s general scope of the work will be to supply the government (specifically the

PVAMC) with rentals of mobile lithotripsy equipment, a certified and credentialed technician to operate the lithotripsy treatments on specific scheduled days designated by the PVAMC. The certified technician will bring the requested lithotripsy rental directly to the operating room at PVAMC for use in operative procedures unless otherwise advised upon arrival. It is expected that all requested machines meet the inspection criteria of the PVAMC Biomed Department.

B. The types of mobile equipment required by this VA facility include:

I. The Lithotripsy machine and the Contractor will provide the necessary attachments, supplies, etc. needed to operate the machine.

C. The machine must be mobile and able to accommodate urologic procedures including but not limited to treatment of benign prosthetic hypertrophy (BPH), kidney stones, lithotripsy, excision of lesions, urological resection, irradiation of tumors in the bladder, and treatment of urethral strictures.

4. CONTRACT PERIOD:

A. Award to be effective October 27, 2024 to October 26, 2025 with four (4) options for renewal (each option 12 months)

5. NAME OF CONTRACTOR:

A. GAM Med Surgical Cons LLC dba Biotechnology Integration & Management, 1100 Mineral Spring Avenue, North Providence, RI 02904

B. Contact: Greg Mercurio, Tel# (401) 255‐7800, email: gamercuriojr@gmail.com C. Contact: Vilma Almagno, Tel# (401) 305‐3633, email: valmagno@bammri.com

6. QUANTITY AND FEES:

A. Contractor shall provide daily rental of lithotripsy and laser equipment to be used in the practice of urology to provide renal lithotripsy treatments, green light laser treatments, and renal laser treatments to eligible VA patients at the PVAMC, Providence, Rhode Island, in accordance with requirements of this contract listed below. The contractor will further provide the Moxy fibers at no additional cost for the Green Light laser and component chips (Microns) as required for the lithotripsy laser in the schedule of fees.

BASE YEAR: October 27, 2024 to October 26, 2025

EQUIPMENT/SUPPLIES UNIT QTY UNIT COST

SHOCK WAVE LITHOTRIPSY RENTAL

Each

TOTAL COST FOR BASE YEAR

OPTION 1: October 27, 2025 to October 26, 2026

TOTAL COST FOR OPTION 1

OPTION 2: October 27, 2026 to October 26, 2027

SHOCK WAVE LITHOTRIPSY RENTAL Each 5

TOTAL COST FOR OPTION 2

OPTION 3: October 27, 2027 to October 26, 2028

SHOCK WAVE LITHOTRIPSY RENTAL Each 5

TOTAL COST FOR OPTION 3

OPTION 4: October 27, 2028 to October 26, 2029

TOTAL COST FOR OPTION 4

TOTAL ESTIMATED VALUE (Base plus four options):

NOTE: These are estimated quantities per year.

7. CONTRACTOR RESPONSIBILITIES:

A. 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.

B. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract, and at the request of the VA, submit another employee for consideration.

C. The contractor will notify the Contracting Officer Representative (COR) immediately when their employee(s) no longer require access to VA computer systems. VA system access must be terminated within 1 day when contractors’ technicians no longer require access to our systems.

D. The Contractor should be available for urgent and add on cases, able to respond to emergencies and provide 1‐2 technicians for each case to operate the equipment.

E. The Contractor is responsible for completing mandatory training programs to meet informational needs and allows the Contractor to function safely and effectively in his/her role within the organization PRIOR to getting access to the VA systems.

F. The contractor is responsible for completing the credentialing process within 7 days of the contract award date. The contractor will also be required to complete an electronic portion of the credentialing process by logging into Vet Pro, the VA’s Credentialing Data Bank at http://fcp.vetpro.org when your login ID and password are provided.

8. CONTRACTOR RESPONSIBILITIES – SHOCK WAVE LITHOTRIPSY EQUIPMENT:

A. Provide a daily rental rate for the use of transportable lithotripsy equipment for one day per month, as scheduled. Daily rate shall include licensed technician(s) to set up, operate and calibrate the equipment.

B. Provide a copy of current licenses and a signed competency assessment from the respective supervisor for each technician present that day.

C. Provide a copy of the maintenance schedule for the specific piece of equipment and current maintenance certification for each piece of equipment being furnished that day.

D. The contractor is responsible for the delivery and removal of the equipment for each daily rental is required.

9. VA RESPONSIBILITIES FOR RENTAL OF EQUIPMENT:

A. Provide space for the equipment.

B. Provide supplies, pharmaceuticals, and disposals.

10. DELIVERABLES AND DELIVERY SCHEDULE:

A. The contractor shall deliver the laser to the PVAMC site not less than 30 minutes prior to the first scheduled procedure for usage by the PVAMC up to the conclusion for the day or part day as agreed.

B. The PVAMC shall afford the contractor not less than 24 hours telephone notice of the time of the first procedure.

C. The contractor may remove the laser or fusion system at the conclusion of the last scheduled surgical procedure.

D. Both the PVAMC and the contractor may, in the event of an emergency, cancel a scheduled day by 24 hours advanced telephone notice to the other. As an alternative, the party giving notice may request that the PVAMC and the contractor adopt an alternative time.

E. Because of the contractor’s itinerary and VA’s patient current health status, commitment, the right to cancel and to request change may be exercised sparingly.

11. GOVERNMENT‐FURNISHED EQUIPMENT AND INFORMATION:

A. The PVAMC certifies each surgeon designated by the VA to operate or assist with the laser and lithotripsy machine is trained and competent in the use of that equipment in his or her surgical capacity.

B. The PVAMC maintains a facility adequate and suitable for the operation of the laser and lithotripsy machine.

C. PVAMC shall perform or cause to be performed all medical services, supervision, diagnosis and patient care in accordance with all applicable professional standards.

D. The contractor will have a certified and/or licensed technician(s) on the premises, readily available, on the day when the procedure(s) is/are being performed. Only PVAMC employees, while in the performance of their official duties and not the contractor’s employees are covered by the Federal Tort Claims Act, 28 U.S.C. §1346(b), 2671 through 2680.

E. The contractor acknowledges that the lasers and lithotripsy machine is in good working condition and is regularly maintained.

F. The contractor will be liable and indemnify the PVAMC for damages should patient injury result due to laser or lithotripsy machine/system malfunction.

G. The contracted vendor acknowledges that it maintains sufficient insurance coverage.

12. PLACE OF PERFORMANCE:

A. This work will be performed at the following government site: Providence VA Medical Center, 830 Chalkstone Avenue, Providence, Rhode Island, 02908, specifically in the PVAMC operating or minor procedure rooms and not at the contractor’s site.

B. The contractor will be responsible for any local or long distance travel for their employees.

13. PERIOD OF PERFORMANCE:

A. The performance period will vary by hour, day, week, or month depending upon the frequency with which the laser equipment and lithotripsy machine is required for patient care.

B. Monthly and/or bimonthly laser rentals are anticipated.

C. The contractor agrees all obligated funds for any type of rental, supplies, equipment, etc.

requested by the PVAMC but not utilized at the end of the contracted period shall be de‐ obligated.

14. SECURITY:

A. The PVAMC Surgical Service, the Operating Room Nursing Service or the designated surgeons shall assure that surgical consent forms have been received from all patients prior to surgery.

B. The contractor is required to enter into a Business Associate Agreement (BAA) with the VA.

15. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS:

A. All contractor employees who require access to the Department of Veterans Affairs computer systems or access to sensitive information shall be the subject of a background investigation.

B. A contractor’s employee shall not commence working at VA under contract until the Contracting

Officer (CO) receives notification from the VA Office of Security and Law Enforcement that the contractor employee’s application was received complete. A favorable adjudication from the VA Office of Security and Law Enforcement must be received in order for a contractor employee to continue contract performance and all required VA training has been completed PRIOR to obtaining access to the VA system. This requirement is applicable to all subcontractor personnel.

C. The position sensitivity has been designated as low risk.

D. The level of background investigation commensurate with the required level of access is

National Agency Check with Written Inquiries (NACI).

16. IDENTIFICATION, PARKING, SMOKING, VA REGULATIONS:

A. The Contractor's technician(s) shall wear visible identification at all times while on the premises of the PVAMC.

B. It is the responsibility of the contractor to obtain parking and the PVAMC will not invalidate or make reimbursement for parking violations or charges for the contractor under any conditions.

C. Smoking is prohibited inside or areas surrounding any buildings at the PVAMC. A designated smoking area is not available.

D. Possession of any type of weapon is prohibited.

E. Enclosed containers, including tool kits, shall be subject to search.

F. Violations of VA regulations may result in citation answerable in the United States Federal

District Court, not a local district, state, or municipal court.