Brand Name or Equal to - Stryker - Thermedx P2000 FluidSmart Fluid Management System. Total Small Business Set-aside

Statement of Need/Work 1. Title of Project: Brand Name or Equal to the Stryker - Thermedx P2000 FluidSmart Management System.

2. Background and Scope of Work: The VA Pittsburgh Healthcare System (VAPHS) Surgical Services department is requesting the purchase of two (2) Brand Name or Equal to the Stryker Thermedx P2000 Fluid Management System for the VA Pittsburgh Healthcare System (VAPHS) Operating Rooms. The Thermedx FluidSmart system is a fluid management system for irrigation, distention, fluid warming, and deficit measurements. This multifunctional system can be used for a variety of procedures in gynecology and urology.

The potential advantages of the continuous warmed and automated fluid irrigation system may include lowered chance of perioperative hypothermia complications and improved operating room (OR) efficiency leading to more cost savings. The Operating Room is open to alternatives that can generate real-time pressure and provide warnings prior to irrigation running dry. We feel these qualities are especially important/valuable in the Operating Room program.

In addition to increased procedural effectiveness and safety, this technology can lead to improved clinical outcomes. 3. Brand Name or Equal (a)Â If an item in this solicitation is identified as brand name or equal, the purchase description reflects the characteristics and level of quality that will satisfy the Government s needs.

The salient physical, functional, or performance characteristics that equal products must meet are specified in the solicitation. (b) To be considered for award, offers of equal products, including equal products of the brand name manufacturer, must- (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation.            (2) Clearly identify the item by-                 (i) Brand name, if any; and                 (ii) Make or model number.            (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements.

Mark any descriptive material to clearly show the modifications. (c)Â The Contracting Officer will evaluate equal products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer.

The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d)Â Unless the offeror clearly indicates in its offer that the product being offered is an equal product, the offeror shall provide the brand name product referenced in the solicitation. The Contractor must comply and provide all necessary information to VA. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government.

4. Data/Deliverables: Item Number Item Description Quantity P2000 FluidSmart Fluid Management System 2 LL0006 FluidSmart Urology Tube Set 5 0502100000 PKG, Fluid Safe 3000CC Canister 4 00835 Thermal Printer Paper 2 Delivery Location Delivery should be coordinated with the COR of the contract prior to shipping of any equipment.

UD Delivery Aloysius Simons Business Resources Specialist, FAC-COR I VA Pittsburgh Healthcare System University Drive C, Room 2A118 Pittsburgh PA 15240 412-360-6587 aloysius.simons@va.gov The Contractor must comply and provide all necessary information to VAPHS. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government. Normal business hours for acceptance of deliveries are 8:00am-3:30pm, Monday thru Friday excluding Federal Holidays.

Deliveries must be coordinated in advance with COR once a ship date is established. The COR, Biomedical Engineering and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. The VA-issued purchase order number must be included in the packing slip. All items included in the requirement shall be shipped and delivered to site at same time. If deliveries must be broken into several shipments due to size, this must be coordinated in advance with the COR.

Failure the coordinate shipment with COR, may result in failure to deliver on site and cause re-scheduling of delivery/freight at no charge to the government. The packing slip must include the VA-issued purchase order number.

PERIOD OF SERVICE: Delivery shall occur within 30 days of receipt of contract or must occur within the timeframe designated by the Federal Government.

SECURITY/NATIONAL AGENCY CHECK REQUIREMENTS: No special security requirements are anticipated. Tuberculosis Prevention Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually. COVID 19 Contractor shall provide evidence of vaccination records or a negative COVID testing result within 72 hours of planned onsite visitation. This is to include installation, training, maintenance, and repairs.

Emergency repairs will be evaluated on a case-by-case situation. HIPAA Training Certificates If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract. Smoking All VA Medical Center s property is smoke-free. Contractor personnel will comply with VA Medical Center s smoking policies. Violations will result in a warning and possible citation.