ATTACHMENT B SOW WIRELESS VIDEO URODYNAMICS SYSTEM.docx

STATEMENT OF WORK

1. BACKGROUND: This equipment will be obtained for VA San Diego women’s health. It offers mobile comprehensive urodynamics testing, including urodynamics, urethral pressure profile, anorectal manometer and video UDS. This also allows pelvic floor diagnostics.

2. PURPOSE: The Aquarius XT is a modular, wireless Urodynamics system that enables healthcare professionals to perform urodynamics studies reproducing real-life scenarios when a patient leaks. Designed for all types of UDS procedures

3. SCOPE: VA San Diego, Surgical Service GYN Division 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.

4. SPECIFIC EQUIPMENT REQUIREMENTS: Equipment must have the physical characteristics to enable the government to perform the capabilities:

4.1. Urodynamic Measurement System with Video

· Unit shall consist of Urocap V Weight Cell Flowmeter to measure urinary flow, urethral pressure profilometer to measure urethral pressure, multi-channel cystometer to measure bladder capacity and response, and electromyographic recording to measure sphincter and other muscle activity.

· Shall be wireless and consist of modular components that enable healthcare professionals to perform urodynamic tests that reproduce real-life scenarios

· It should be able to perform the following procedures: Urodynamics (UDS) with Urethral Pressure Profile (UPP), Anorectal Manometry (ARM) and Video UDS

· Touchscreen hub with infusion pump

· Dual Touchscreen monitors

· Two custom carts with LIT

· 110V LIT

· Inkjet printer on cart

· PDF printer

· Fluid filled pressure transducers: Long

· Air charged pressure transducers: Long

· EMG: 2 EMG recording channels with very high definition

· Shall include All-in-One PC, Windows 10 64-bit LTSB, Dual 24″ LCD screens

· Dimensions: 56 x 62 x 123 cm, 20 kg & 63.5 x 66-118 x 153-180 cm, 56 kg

· Includes isolation transformers for all components

· 12 Month Manufacturer warranty

· Quantity: 1

5. FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: Equipment must provide the functional and performance capability as listed above in the section above.

6. SOFTWARE: N/A

7. INSTALLATION AND TRAINING:

· Delivery must be with thirty (30) days of ordering.

· Complete installation and go live must be completed within sixty (60) of delivery.

· The vendor shall ensure all equipment delivered is fully operational to manufacturer’s specification and free from defect.

· The vendor shall provide delivery, set up, and technical support for clinical staff and clinician training for using the system.

· The vendor shall report all recalls, removals, modifications and safety notices from the manufacturer, distributor and FDA, and provide immediate notices (within 48 hours) to the Contracting Officer and the facility point of contact and the VHA Product Recall Office for any notices identified for medical devices.

· The vendor shall coordinate with VA Supply Chain Management or facility appropriate contact agree upon delivery day and arrival to the facility.

· The vendor shall provide digital format operations manuals include the care, handling, set up, and cleaning instruction of the mobile and multi-modality guidance intravascular imaging system.

The Contractor shall provide all management, tools, parts, materials, equipment, travel, and labor necessary to provide and install the instrumentation described above. The 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 will be coordinated with VA POC Jose A Rodriguez

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

9. PERFORMANCE:

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

· Delivery and receipt of the proposed items is expected to be directed to the location identified below. Confirmation of delivery location will be provided by the VA POC post-award. Delivery must be coordinated with VA COR 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.

· 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 POC onsite.

· 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 POC or designee.

· 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”

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

· 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.

· 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.

· 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.

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

10. PLACE OF DELIVERY: VA San Diego, Surgical Service, GYN Division Room #3025– 3350 La Jolla Village Drive, San Diego, CA 92161

11. VA POC

Jose Rodriguez 325-548-6000 Jose.Rodriguez5@va.gov

12. SECURITY

Information Security

· 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’s 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.

· 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 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.