Statement of Work-Viasonix Falcon Pro OR EQUAL Physiologic Vascular Testing System-RFI 36C26226Q0374.pdf

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6515--36C26226Q0374 Viasonix Falcon Pro OR EQUAL Physiologic Vascular Testing System 664-26-2-072-0114
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36C26226Q0374
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This is a draft Statement of Work (SOW) for the Department of Veterans Affairs (VA) San Diego facility requesting replacement of obsolete peripheral vascular diagnostic equipment. The VA San Diego Surgical Services Vascular Lab seeks a Falcon Peripheral Vascular Diagnosis System or equivalent to replace current Falcon/Pro and Falcon/Quad equipment that has reached end-of-life status after 10+ years of use. The manufacturer has ceased support for repairs due to the equipment's age and technical obsolescence. The replacement equipment will be used to diagnose peripheral vascular abnormalities in the Vascular clinic.

The required equipment must meet specific salient characteristics including at least 10 independent pressure channels for simultaneous blood pressure measurements across various limb segments, at least 5 independent Photoplethysmography (PPG) sensors for diagnosing conditions like Raynaud's syndrome, a 10MHz (±1MHz) Doppler probe for measuring small peripheral blood vessels, capability to measure Ankle Brachial Index (ABI) and Thoracic Index (TBI), and a user-friendly interface supporting unlimited configurable user-defined protocols and reports. The contractor must provide complete installation, on-site training coordinated with VA POC Jose A Rodriguez (858-210-5381), and standard manufacturer warranty. Delivery location is VA San Diego, Surgical Service, 5N Vascular Clinic RM# 5321, 3350 La Jolla Village Drive, San Diego, CA 92161. The contractor is responsible for offloading, uncrating, setup according to manufacturer specifications, equipment testing, waste removal, and all shipping costs. Work must be performed during normal duty hours (8:00 a.m. to 4:00 p.m., Monday through Friday, excluding federal holidays), with coordination required for any outside-hours work. Additional requirements include information security compliance with VA standards, FISMA requirements, and background investigations for all contractor personnel requiring access to VA computer systems.

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STATEMENT OF WORK (DRAFT)

Statement of Work is tentative and subject to change based on responses received for the RFI.

1. GENERAL: VA San Diego, Surgical Services Vascular Lab is requesting a replacement

Falcon Peripheral Vascular Diagnosis System OR EQUAL to replace current equipment due to not been supported and been phase out by the Manufacture.

2. BACKGROUND: This request is to replace the Falcon/Pro and Falcon /Quad that the

Manufacture will not provide parts for repairs due to equipment ageing 10+yrs. Recently issues with our Falcon machines for the most part were fixed, however, Company stated that since our machines are over 10 years old, if something major happens they will be unable to repair them, past life expectancy. The existing machines are reaching technical obsolescence.

3. PURPOSE: Replacement of a broken Falcon/PRO’s that have reached end of life and no longer been supported by the manufactured. The Equipment is frequently used in the Vascular to diagnose peripheral vascular abnormalities.

4. SCOPE: VA San Diego, Surgical Service Vascular Lab is requesting contractors to provide brand name or equal equipment that meets or exceed the physical, functional, and performance of the listed salient characteristics in this section. The equipment feature is essential to the technical requirements to meet the needs of the department.

5. SALIENT CHARACTERISTICS: Equipment must have physical characteristics to enable the government to perform the capabilities:

Falcon/PRO Physiologic Vascular Testing System:

5.1. Must have at least 10 Independent Pressure Channels to allow simultaneous measurements of blood pressure in various limb segments.

5.2. Must have at least 5 independent Photoplethysmography (PPG) sensors that are useful for diagnosing conditions like Raynaud’s syndrome.

5.3. Doppler probe must be of 10mhz (+/- 1mhz) designed for measuring small peripheral blood vessels effectively.

5.4. Must be able to quickly measure Ankle Brachial Index (ABI) and Thoracic (TBI)

5.5. Must have a user-friendly interface that supports unlimited configurable user-defined protocols and reports.

6. INSTALLATION AND TRAINING: The Contractor shall provide all management, tools, parts, materials, equipment, travel, and labor necessary to provide and install the instrumentation described above. Contractor will be required to provide an on-station in-service on the proper use and setup of the equipment and training to the end user. Training sessions if applicable will be coordinated by VA POC Jose A Rodriguez.

7. WARRANTY OF EQUIPMENT: Government requirement for standard manufacturer industry warranty term. The government does not accept an extended warranty, which requires advance payment.

8. PERFORMANCE:

8.1. All items are to be delivered and or installed after receipt of purchase order.

8.2. Delivery and receipt of the proposed items is anticipated to be directed at the location identified below. Confirmation of delivery location will be provided by the VA POC post-award. Delivery must be coordinated with VA POC Jose A Rodriguez (Cell):

858-210-5381 prior to any attempts at delivery. Any item that has not been coordinated will be turned away and any additional charges will be the responsibility of the sender/transportation company.

8.3. Vendor`s responsibility will include offloading the equipment from the truck, moving the equipment to the correct delivery location in the space, uncrating or unboxing the equipment then removing all trash, and setting up the equipment according to the manufacturer`s specification followed by testing the equipment to verify that it is operational. Equipment installation paperwork & warranty information must be handed to the approved government contact onsite.

8.4. Hours: Normal duty hours are 8:00 a.m. through 4:00 p.m., Monday through Friday, not including federal holidays. Whenever contact with a facility is required outside of normal duty hours, the Contractor shall coordinate these times with the designated COR, POC or designee.

8.5. In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays”

New Year’s Day January 1st Martin Luther King’s Birthday Third Monday in January President’s Day Last Monday in February Memorial Day Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veteran’s Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th

8.6. Noncontract Charges: The contractor shall not perform any service that will result in additional charges without prior approval from the Contracting Officer.

8.7. Payment: Payment will be made upon receipt of a properly prepared invoice which references the period for which payment is due, the contract number and/or assigned purchase order number. The invoice must include the correct payment address.

8.8. Waste Removal: The contractor is responsible for removing and properly disposing of all waste related to the services provided on-site at all VA facilities.

8.9. Failure to carry out the above procedures will be considered as a failure to document the service visit and will constitute a failure to perform.

8.10. All shipping for parts will be included in the cost of the contract.

9. PLACE OF DELIVERY: VA San Diego, Surgical Service, 5N Vascular Clinic RM# 5321.– 3350 La Jolla Village Drive, San Diego, CA 92161

10. SECURITY

Information Security

10.1. The vendor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The vendor’s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA Project Manager and the VBA Headquarters Information Security Officer as soon as possible. The vendor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation.

10.2. The contractor shall follow The Veterans Affair Acquisition Regulation (VAAR) security clause VAAR- 852.273-75 “SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES” sited in section C. Contract Clauses

(a) The contractor and their personnel shall be subject to the same Federal laws, regulations, standards, and VA policies as VA personnel, regarding information and information system security. These include but are not limited to the Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A- 130, and guidance and standards, available from the Department of Commerce's National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST's Web site at:

http://checklists.nist.gov

(b) To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in "VA Information and Information System Security/Privacy Requirements for IT Contracts" located at the following Web site:

http://www.iprm.oit.va.gov

Contract Personnel Security

10.3. All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004, and is available at:

http://www.va.gov/pubs/asp/edsdirec.asp (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award and are to be completed and returned to the VA Security and Investigations Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access.

If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for the resources necessary to remedy the incident.

http://checklists.nist.gov/ http://www.iprm.oit.va.gov/

STATEMENT OF WORK (DRAFT)

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