36C24123Q1156.docx

Presolicitation Notice Presolicitation Notice

GENERAL INFORMATION

SET-ASIDE

VAMC West Haven

950 Campbell Avenue

West Haven CT

CONTACT INFORMATION

VA Connecticut

950 Campbell Avenue West Haven CT 06516-2770

POINT OF CONTACT*

Contract Specialist Chadwin Walker chadwin.walker@va.gov

ADDITIONAL INFORMATION

DESCRIPTION

Boston Scientific Spyglass DS Digital Controller System INTENT TO SOLE SOURCE: PROCUREMENT OF ONE (1) Spyglass DS Digital Controller System

INTENT TO SOLE SOURCE FOR PURCHASE REQUISITION: This is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available and telephone requests will not be honored.

The Department of Veterans Affairs Providence Medical Center intends to award a one-time, Firm Fixed Price, Sole Source contract for One (1) Spyglass DS Digital Controller System to VAMC West Haven, Original Equipment Manufacturer Boston Scientific Corporation.

Technology, knowledge, technical expertise, and servicing capabilities for the Spyglass DS Digital Controller System are proprietary to Boston Scientific Corporation.

A Sole Source Letter was provided by the Original Equipment Manufacturer (OEM) describing the proprietary nature of the Spyglass DS Digital Controller System establishing this requirement as being peculiar in manufacturing to Boston Scientific Corporation. The letter states that only SDVOSB Veterans Healthcare Supply Solutions is authorized to distribute the Spyglass DS Digital Controller System.

The authority for applying the Simplified Acquisition Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901. This statute is implemented by for restricting competition on this procurement via FAR 8.405-6(a)(1)(i)(B).

The intent is to procure these products on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 339113: Medical and Surgical Instruments, Equipment, and Supplies. The most current Business Size Rating for this NAICS is 800 employees.

Capable parties may identify their interests and authorization to respond to this requirement by September 18th, 2023, at 12:00 PM (EDT).

A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Contracting Officer.

STATEMENT OF WORK FORMAT

NON-PERSONAL SERVICES

1. INTRODUCTION/BACKGROUND:

At the West Haven VA, we offer advanced endoscopic care to our veterans. This allows us to treat patients with complex pancreaticobiliary disease and to avoid outsourcing their care. Part of this complex care entails adequate evaluation and treatment of biliary and pancreatic duct disease. The Spyglass Direct Visualization system is essentially an updated cholangioscope with improved optics. It allows us to directly visualize the bile duct and the pancreatic duct. This allows us to evaluate for tumors, stones and other lesions. The autolith equipment allows us to break up large stones using lithotripsy. Overall, this equipment is an integral part of an advanced endoscopy program. Our current endoscopist has experience using these devices. Recently, a veteran was outsourced to our academic affiliate for these devices to be used to break up a large bile duct stone. A good review of the literature can be found at Electrohydraulic lithotripsy in the treatment of bile and pancreatic duct stones - UpToDate

2. OBJECTIVE:

The objective is to acquire the Spyglass system which includes the processer/interface that incorporates into our current endoscopy tower to allow us to capture and save images. The actual autolith/EHL probes and the cholangioscopes/Spyglass devices are disposable single-use. Biomed would need to help us integrate the permanent equipment into our current endoscopic set-up. We would then need to buy the disposables. Technicians and assistants would be trained on use of the new equipment.

3. MAJOR REQUIREMENTS:

The Government and the Contractor understand and agree that the services to be delivered under this contract by the Contractor to the Government are non-personal services and the parties recognize and agree that no employer-employee or master-servant relationships exist or will exist under the contract between the Government and the Contractor’s employees.

4. GOVERNMENT FURNISHED INFORMATION OR MATERIAL:

a. If the contract includes Government-furnished property (GFP), identify in the Statement of Work all available information on GFP to be provided, including the make, model, bar code number and serial number, if available, of all accountable assets with an acquisition cost of $500 or more.

b. If the contract includes Contractor-acquired property (CAP), identify the following in the Statement of Work:

(1) All available information on CAP, including the make, model, and serial number, if available, of accountable assets with an acquisition cost of $500 or more. If this information is contained in the Contractor’s proposal, reference the location and the items for which the Government has granted approval to purchase.

(2) If title to CAP shall be vested in the Government upon completion of the project, require a letter report under the deliverables to be submitted which specifies all the required information on CAP following its acquisition. Include a sentence substantially the same as the following: “The Contractor shall provide information on the property acquired for the performance of this contract to include the make, model, serial number, and purchase price. A copy of this letter report shall be submitted upon acquisition of the property to the COR at the address specified in Paragraph __ and the Property Book Officer (PBO) at ___. Upon receipt, the PBO will forward a barcode to the Contractor which shall be attached to the property.”

c. Disposition instructions of all GFP/CAP

(1) If title to GFP or CAP is vested in the Government upon completion of the project, include a sentence substantially the same as the following in the Statement of Work: “A Property Control Receipt (ENG Form 4900-R) will be submitted to the Contractor (with the equipment if GFP, upon receipt of the letter report for CAP). The Contractor shall complete and return this form to the Government within __ days after receipt.”

(2) If the Contractor is to retain the property for use on future projects, include a sentence substantially the same as the following: “The Contractor is prohibited from charging the Government any usage or rental type fees for use of this equipment during the performance of this or any future Government project.”

d. A statement that the COR is the Property Administrator for said property

5. MEETINGS AND REVIEWS:

List required meetings/reviews, purpose, location and time schedule. N/A

6. TRAVEL REQUIREMENTS:

List number of trips, location, number of days per trip, number of people the Government expects to travel. N/A

7. CONTRACTING OFFICER'S REPRESENTATIVE (COR):

a. Identify the Government personnel (and an alternate, if possible) and phone number who will be the technical representative. Dr. Gyanprakash Ketwaroo 203-932-5711

b. Include the following paragraph: "No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification."

8. REPORTS/DELIVERABLES:

a. List specific reports/deliverables required of the Contractor either in satisfaction of the task definition or to enable the Principal Investigator to manage the contract. N/A

b. Include types, frequency or timetable, contents of reports and other data, and quantities. N/A

c. Monthly progress reports must be included as a deliverable to properly monitor the contract or task order. N/A

9. PERIOD OF SERVICE:

Specify a time by which all work to be performed under the order will be completed. This can be stated as a date or in terms of days or months from the date of award of the order. Used on a regular basis permanently until equipment needs to be replaced.

10. CONTRACTOR QUALIFICATIONS:

When appropriate, list the qualifications that are deemed to be required in order to perform the services adequately.

Spyglass system allows a single operator to perform targeted biopsies

a. Required for Purchase Orders with a bidder’s list or when published in the FedBizOpps. N/A

b. Not required for Sole Source under $25k. N/A

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.

Presolicitation Notice