P09 Statement of Need THOPAZ CHEST DRAINAGE SYSTEM.pdf

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Attached to
6515--Thopaz Drainage System Federal contract opportunity
Solicitation number
36C24825Q0896
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 8

About this file

This Statement of Work (SOW) details the James A. Haley Veterans' Hospital's requirement for the Thopaz Digital Chest Drainage and Monitoring System, manufactured specifically by Medela. The procurement is for a sole-source, name-brand only system (Model #101030215) that provides continuous, objective measurement of air leaks and fluid drainage for post-operative thoracic patients. Key system requirements include being user-friendly, portable, lightweight, providing real-time clinical data, operating independently for at least 4 hours when fully charged, and supporting early patient mobility.

The contract specifies delivery within 30 days After Receipt of Order (ARO) to the hospital located at 13000 Bruce B. Downs Blvd, Tampa, FL 33612, with Free Onboard Destination (FOB) terms. The system must be new, accompanied by standard manufacturer accessories and manuals, and include the manufacturer's standard warranty. The procurement is being conducted as a sole-source contract under FAR 13.106-1(b), with the government determining that only Medela can satisfy the unique requirements for a digital chest drainage monitoring system.

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STATEMENT OF WORK

GENERAL: James A. Haley Veterans’ Hospital, 13000 Bruce B. Downs Blvd, Tampa, FL, has a requirement for Thopaz chest drainage system for continuous and objectively measures air leak and fluid drainage. This facilitates the assessment of patient’s progress as well as the standardization of chest drainage management of post operative thoracic cases across different departments.

BACKGROUND: Thopaz is a light compact device with silent builtin suction pump, so does not need to be attached to a wall suction. The sensor measurements allow for objective quantification of air leak and fluid management. It favors early patient mobilization, reduces chest tube duration, shortens hospital stays and reduces costs.

SCOPE: This procurement is for the Thopaz Digital Chest Drainage and Monitoring System (Name Brand Only), manufactured by Medela. No substitutions or equivalent products will be accepted. The requested system provides uninterrupted, continuous drainage for efficient mediastinal and pleural drainage immediately following thoracic surgery.

PHYSICAL CHARACTERISTICS:

• Equipment must accurately quantify air leaks and fluid drainage.

• Must provide uninterrupted drainage to the patient.

• Must be designed to support early patient mobility.

• Must contribute to reducing chest tube duration, hospital stays, and associated costs.

FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: The Thopaz system must meet or exceed the following requirements, based on industry standards and enduser recommendations:

• Must come with a standard power cord.

• Docking station must display charging status of the pump.

• Docking station must indicate loss of power.

• Device must be userfriendly, portable, and lightweight.

• Device must provide objective, realtime data for clinical decisionmaking.

SPECIFIC NEED/SALIENT CHARACTERISTIC’S:

• Manufacturer: Medela

• Model Number: Item #101030215 (Pump with docking station)

• System must be new, not refurbished or reconditioned.

• System must be accompanied by all standard manufacturer accessories and manuals.

PERFORMANCE MONITORING:

• The docking station shall adequately charge the pump.

• When fully charged, the pump must operate independently for a minimum of 4 hours.Docking station will adequately charge the pump and fully charged pump will last for at least 4 hours

PLACE OF DELIVERY AND PERFORMANCE: James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, FL 33612.

DELIVERY SCHEDULE: All items to be delivered within 30 days ARO with Free Onboard Destination (FOB).

WARRANTY OF EQUIPMENT: Contractor must provide standard manufacturer(s) warranty on devices.

File details come from the government source that posted it. Updated .