Olympus GI Endoscope Lease Statement of Work Updated.doc

Statement of Work for GI Endoscope Lease for San Francisco

1. SCOPE

The San Francisco VA Medical Center is seeking to lease new endoscopes for the Gastroenterology department. Gastrointestinal endoscopes are complicated, flexible instruments that are inserted through the mouth and rectum and into the intestines in order to visualize and diagnose intestinal disorders, to obtain biopsies, and to insert various instruments in order to treat bleeding, remove tumors, and insert stents. The tube that is inserted into the patient (“insertion tube”) has a video chip (CCD chip) that transmits a video image. The tube also has fiber optic light bundles through which xenon can be projected into the intestine in order to view the intestinal lining. The endoscopes are connected to a video processor and light source in order to function. The light source provides illumination for the scope while the video processor manages the input from the video chip of the endoscope. Currently San Francisco maintains a fleet of Olympus endoscopes, light source, and video processors. However, the current lease on the endoscopes is set to expire on 12/31/2021 and we will need a new endoscope lease in place that can interface with our CV190 Video Processors and CLV190 Light Sources from Olympus to ensure continued functionality of the GI clinic without interruption. This will be a 12-month lease with three 12-month options for Olympus endoscopes.

2. DEFINITIONS/ACRONYMS:

CO: Contracting Officer

COR: Contracting Officer's Representative

GI: Gastroenterology

ESR: Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

Authorization Signature: COR signature indicates COR accepts work status as stated in ESR.

Insertion Tube OD: Outer diameter of the scope.

Channel ID: Diameter of the channel within the scope through which instruments are inserted.

Field of View: The largest angle subtended at the lens by two objects that can be seen with the scope.

Depth of Field: The distance along the principle axis of the lens that can be clearly seen with the scope.

Gastroscope: An endoscope that is used to diagnose and treat the upper gastro-intestinal tract including the esophagus and the stomach.

Colonoscope: An endoscope that is used to diagnose and treat the lower gastro-intestinal tract including the colon and ileum.

Duodenoscope: An endoscope that is used to diagnose and treat the middle portion of the gastro-intestinal tract specifically the duodenum.

Enteroscopes: An endoscope that is used to diagnose and treat the upper portion of the small intestine, which is called jejunum.

Bending (Up/Down): The motion of the scope while it is inside the gastrointestinal tract of a patient that is in a supine position towards and away from the ground.

Bending (Left/Right): The motion of the scope while it is inside the gastrointestinal tract of a patient that is in a supine position in the plane parallel to the ground.

3. SPECIFICATIONS

General Characteristics for All Scopes including Gastroscopes, Colonoscopes, Enteroscopes, and Duodenoscopes:

· Must be compatible with Video System Center Olympus CV-190

· Must be compatible with Light Source Olympus CLV-190 General Gastroscopes Characteristics:

· Bending (Up/Down): 210/90 Degrees (Tolerance = ±5 Degrees)

· Bending (Left/Right): 100/100 Degrees (Tolerance = ±5 Degrees)

· Field of View: 140 Degrees (Tolerance = ±5 Degrees) Specific Gastroscopes Characteristics:

GIF-2TH180 (Therapeutic 2-Channel Video Gastroscope)

· Insertion Tube OD: 12.6 mm (Tolerance = ±0.25 mm)

· Channel ID: A:2.8/B: 3.7 mm (Tolerance = ±0.25 mm)

· Working Length: 103 cm (Tolerance = ±5 cm)

· Depth of Field: 2-100 mm (Tolerance = ±2 mm)

· Narrow band imaging mode

· Forward water jet GIF-1TH190 (Therapeutic 1-Channel Video Gastroscope)

· Insertion Tube OD: 10.9 mm (Tolerance = ±0.25 mm)

· Channel ID: 3.7 mm (Tolerance = ±0.25 mm)

· Working Length: 103 cm (Tolerance = ±5 cm)

· Depth of Field: 2-100 mm (Tolerance = ±2 mm)

· Narrow band imaging mode

· Forward water jet GIF-HQ190 (Video Gastroscope)

· Insertion Tube OD: 9.9 mm (Tolerance = ±0.25 mm)

· Channel ID: 2.8 mm (Tolerance = ±0.25 mm)

· Depth of Field Near: 2-6 mm (Tolerance = ±0.5 mm)

· Depth of Field Normal: 5-100 mm (Tolerance = ±2 mm)

· Working Length: 103 cm (Tolerance = ±5 cm)

· Dual focus including near and normal

· Narrow band imaging mode

· Forward water jet

GIF-XP190N (Ultra Slim Video Gastroscope)

· Insertion Tube OD: 5.8 mm (Tolerance = ±0.25 mm)

· Channel ID: 2.2 mm (Tolerance = ±0.25 mm)

· Depth of Field: 3-100 mm (Tolerance = ±2 mm)

· Working Length: 110 cm (Tolerance = ±5 cm)

· Narrow band imaging mode

· Dual light guides General Colonoscope Characteristics:

· Bending (Up/Down): 180/180 Degrees (Tolerance = ±5 Degrees)

· Bending (Left/Right): 160/160 Degrees (Tolerance = ±5 Degrees)

· Working Length: 168 cm (Tolerance = ±10 cm)

· High Definition Camera

· Narrow Band Imaging

Specific Colonoscope Characteristics:

PCF-HQ190DL (Slim Colonoscope w/ Dual Focus NBI)

· Insertion Tube OD: 11.8 mm (Tolerance = ±0.25 mm)

· Channel ID: 3.2 mm (Tolerance = ±0.25 mm)

· Field of View: 170 Degrees (Tolerance = ±5 Degrees)

· Depth of Field: 2-100 mm (Tolerance = ±2 mm)

· ScopeGuide technology

CF-HQ190L (Video Colonoscope)

· Insertion Tube OD: 12.8 mm (Tolerance = ±0.25 mm)

· Channel ID: 3.7 mm (Tolerance = ±0.25 mm)

· Field of View Normal: 170 Degrees (Tolerance = ±5 Degrees)

· Field of View Near: 160 Degrees (Tolerance = ±5 Degrees)

· Depth of Field Normal: 5-100 mm (Tolerance = ±2 mm)

· Depth of Field Near: 2-6 mm (Tolerance = ±2 mm)

· Dual focus including near and normal

Specific Enteroscope Characteristics (SIF-Q180):

· Insertion Tube OD: 9.2 mm (Tolerance = ±0.25 mm)

· Channel ID: 2.8 mm (Tolerance = ±0.25 mm)

· Bending (Up/Down): 180/180 Degrees (Tolerance = ±5 Degrees)

· Bending (Left/Right): 160/160 Degrees (Tolerance = ±5 Degrees)

· Working Length: 200 cm (Tolerance = ±10 cm)

· Field of View: 140 Degrees (Tolerance = ±5 Degrees)

· Depth of Field: 3-100 mm (Tolerance = ±2 mm)

· Narrow Band Imaging

Specific Duodenoscope Characteristics (TJF-Q190V):

· Insertion Tube OD: 11.3 mm (Tolerance = ±0.25 mm)

· Channel ID: 4.2 mm (Tolerance = ±0.25 mm)

· Bending (Up/Down): 120/90 Degrees (Tolerance = ±5 Degrees)

· Bending (Left/Right): 90/110 Degrees (Tolerance = ±5 Degrees)

· Working Length: 124 cm (Tolerance = ±5 cm)

· Field of View: 100/5 (Backward side viewing) Degrees (Tolerance = ±2 Degrees)

· Depth of Field: 5-60 mm (Tolerance = ±2 mm)

· Narrow Band Imaging

· Dual locking mechanism for secure guide wire locking Olympus shall provide the most updated technology for the GIF-HQ190, CF-HQ190L, and SIF-Q180 after the base year or when the updated technology is available for lease, whichever comes first.

4. Trade in of exsisting equipment

· All trade-in equipment has been addressed in previous iterations of this lease agreement.

5. Delivery Location:

San Francisco VAMC (4150 Clement Street San Francisco, CA 94121)

• (Qty: 1) Therapeutic 2-Channel Video Gastroscope, Model GIF-2TH180

• (Qty: 8) Video Gastroscope, Model GIF-HQ190

• (Qty: 2) Ultra-Slim Video Gastroscope, Model GIF-XP190N

• (Qty: 1) Ultra-Slim Video Colonoscope, Model PCF-PH190L

• (Qty: 6) Slim Colonoscope w/ Dual Focus NBI, Model PCF HQ190DL

• (Qty: 14) Video Colonoscope, Model CF-HQ190L

• (Qty: 3) Video Duodenoscope, Model TJF-Q190V

• (Qty: 3) Therapeutic 1-Channel Video Gastroscope, Model GIF-1TH190

• (Qty: 1) Therapeutic Enteroscope, Model SIF-Q180

6. DELIVERY AND ACCEPTANCE

Delivery of the equipment shall be F.O.B. destination point. Upon delivery to the equipment location, customer shall inspect the equipment and give written notice of acceptance or rejection within 60 days from the date of delivery of the Equipment.

7. LOSS OR DAMAGE

The contractor shall be responsible for all loss or damage to the equipment during periods of transportation and installation. If any accessory is lost while the equipment is in the possession of the customer, the contractor shall not be held responsible. The cost of the item lost shall be determined by the fair market value, compensating for depreciation, at the time of the loss. Should the equipment need to be relocated, the contractor shall assist with the relocation of the equipment, if required, at no cost to the customer.

8. OWNERSHIP

The Equipment shall remain in the possession of customer until expiration or earlier termination of the lease. Any assignment, sale, bankruptcy, or other transfer of the equipment by the contractor will not relieve the contractor of its obligations to customer and will not change customer’s duties or increase the burdens or risks imposed on the customer under this lease. The customer may elect to purchase any or all of the equipment at the expiration of the completed term upon making a payment to contractor of an amount equal to the equipment’s fair market value. Upon payment, thorough inspection, and needed repair and maintenance, the contractor shall transfer the title of the equipment to the customer.

9. Repair Services/Warranty:

Upon notification from customer of a defective endoscope, contractor will provide repair service, which may consist of calibrations, adjustments, part replacements, complete system refurbishment, and other repair services. All aspects of repair and maintenance will be included: loaners, shipping, and all parts and services.

10. PARTS:

The Contractor shall furnish and replace parts to meet original manufacture’s specifications for operation, safety, and regulatory. The Contractor has ready access to all Original Equipment Manufacture parts, including unique and/or high failure replacement parts. All parts supplied shall be from the Original Equipment Manufacturer. The contract shall include all parts, which shall be of current manufacture and have complete versatility with the leased equipment. All parts shall perform identically to the original equipment specifications.

11. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

A.

The service shall only be performed by personnel who are fully qualified and trained by original equipment manufacturer.

B.

The term "Fully Qualified” is based upon training and experience in the field. In order to be fully qualified, the service personal shall have successfully completed a formalized training program for the particular piece of equipment.

C.

Contractor shall provide written assurance of the competency of their service personnel and a list of credentials of the service personnel for every make and model of the scope. The CO may authenticate the training requirements, request training certificates or credentials from Contractor at any time for any personnel who are servicing any equipment. The CO and/or the Chief Biomedical Engineer or their designee specifically reserves the right to reject any of the Contractor's personnel and refuse them permission to work on the equipment.

D.

All Contractor scopes shall only be serviced by original equipment manufacturer. No scope repairs shall be done by a third party.

12. DOCUMENTATION/REPORTS:

Contractor shall provide detailed documentation for all inspections and repair services. The documentation shall include detailed descriptions of the repair/warranty services performed including replaced parts required to maintain the equipment in accordance with original equipment manufacturer's specifications. This includes detailed documentation to satisfy any incidents associated with leased equipment. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail:

A. Name of contractor and contract number B. Name of FSE who performed services C. Contractor service ESR number/log number D. Date, time (starting and ending), equipment downtime E. Description of problem reported

F. Identification of equipment to be serviced:

1. Manufacturer's name

2. Device name

3. Model number

4. Serial number

5. Any other manufacturer's identification numbers G. Itemized Description of following Service Performed will be included:

1. Labor

2. Parts (with part numbers)

3. Materials and Circuit Location of problem/corrective action.

13. PAYMENT:

There shall be no payments made for anything other than the leasing costs. All costs of repair, service, loaners, shipping, etc. will be covered under this contract. The contractor shall bill partially for the first and last month if applicable. The monthly payments shall remain the same for every month unless the lease is modified. This fixed sum shall also continue through the complete lease terms to include any option years.

14. TAXES:

The contractor shall not charge taxes because the customer is a Federal Government entity.

15. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

Although all costs pertaining to the equipment will be covered under this contract, should there be any reason for a contractor to believe, for any reason, that they will not cover any costs associated to damage, repair, or service to the equipment, the contractor shall notify the CO and the Chief Biomedical Engineer within 24 hours. The contractor shall immediately notify the CO and the Chief Biomedical Engineer in writing of the existence of any defects in, or repairs required to, the leased equipment, which the contractor considers he/she is not responsible for under the terms of the contract.

16. CONDITION OF EQUIPMENT:

The Contractor accepts responsibility for the equipment being used for trade-in value. Failure to inspect the trade-in equipment prior to contract award will not relieve the contractor from any value associated with estimates provided in proposals.

All used equipment that is sent from customers to the contractor shall be disinfected, sterilized, and made safe to operate and handle. Every such piece of equipment that leaves the facility shall be clearly identified as disinfected and/or sterilized.

All scopes that are going to be leased will be brand new. If a scope is damaged beyond repair, the contractor shall replace the scope with an equivalent scope that is brand new. There will be no cost associated with this exchange. All costs that will be associated with this type of an exchange shall be coved under this contract.

17. IDENTIFICATION AND PARKING:

Contractor personnel, while on VA premises, shall wear visible identification at all times. The service or sales personnel shall follow all the local policies in terms of identification and entry on VA premises. Entry and egress procedures of the facility should be followed by sales and service professionals at all times.

It is the responsibility of contractor to park in the appropriate parking areas. If parked in areas other than those that are appropriate, contractor will be liable for all fines that occur as a result. Information on parking is available from each VA Police department.

Possession of weapons and firearms on any VA facility is prohibited.

Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

18. RETURN OF EQUIPMENT

If the customer wants to return the equipment at any time such as early termination of lease, end of lease term, repair of equipment, maintenance of equipment, the contractor shall bear all the costs associated with the transportation of the equipment from one location to another along with any insurance if needed. The contactor shall be liable for any damage that occurs during transportation of the equipment. After receiving the equipment, the contractor shall inspect the equipment and if there are any instances where the contractor believes that customer is liable for the damage, he shall notify the CO and the Chief Biomedical Engineer in writing within 24 consecutive hours.

19. TERMINATION

The customer may choose to terminate the lease at any time should it determine that there is no need of the equipment listed herein, or the need for functionally similar equipment, and the contractor shall not charge any lease termination fees of any kind if the customer chooses to exercise this option.

The customer may also terminate the lease for convenience of the Government. Contractor shall not charge cost of supplies, maintenance, usage charges, interest expense, or any other charges whatsoever other than the termination cost.