Attachment A - Performance Work Statement.docx
DOCX document 18 KB Posted
- Attached to
- 6515--Confocal Laser Endomicroscopy System
- Solicitation number
- 36C26226Q1289
About this file
This is a Performance Work Statement (PWS) for a Confocal Laser Endomicroscopy System procurement by the Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, for the Pulmonary Endoscopy Lab at VA Greater Los Angeles Healthcare System.
The RFI seeks qualified sources capable of providing a Confocal Laser Endomicroscopy System meeting specified salient characteristics. The procurement falls under NAICS 339112 (Medical, Dental, and Surgical Instrument and Supplies Manufacturing) with a size standard of 1,000 employees. This is a sources sought/RFI issued solely for information and planning purposes and does not constitute a formal solicitation. Responses are encouraged and allowed per FAR 15.201(e); however, responses are not offers and cannot form binding contracts. The Government will use submitted information regarding qualified sources and their size classifications to inform subsequent acquisition decisions. Interested vendors should demonstrate their capability to meet the system requirements outlined in the PWS. Following review of responses, the VA may publish a formal solicitation announcement. Responders bear all costs associated with responding to this RFI.
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| 36C26226Q1289.docx | DOCX document |
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Performance Work Statement
BACKGROUND and PURPOSE
VAGLAHS, West Los Angeles Medical Service-Pulmonary and Critical Care received notification from facility Biomedical Engineering Department about current Cellvizio, confocal laser endomicroscopy system, has reached end of life and therefore we are requesting to replace the system.
SCOPE
The Contractor shall deliver and install 1 unit of Confocal Laser Endomicroscopy System at 11301 Wilshire Blvd., Los Angeles, CA 90073, Bldg. 500, 5 East, Pulmonary Endoscopy Lab, inside of Clinical Procedure Unit with essential/significant physical, functional, or performance characteristics listed below.
a) Salient Characteristics of a confocal laser endomicroscopy system include:
· Endoscope with a working channel of at least 2.8mm is required for the probe-based system
· Confocal probe or a mini probe
· System is optimized for using contrast agent, such as intravenous fluorescein, for enhanced imaging
· System must be FDA cleared through 510(k) process
· Must be able to provide real-time microscopic imaging of the mucosal epithelium during endoscopy
b) Industry Standard for a confocal laser endomicroscopy system: FDA clearance of endoscope based and probe-based systems. The confocal laser endomicroscopy system is designed to provide high-resolution, real time imaging capabilities during Pulmonary Endoscopic procedures.
VA GLA POC: Sabrina Lee at (310) 268-3011 or Sabrina.lee@va.gov
REQUIREMENTS
· The Contractor shall deliver and install 1 unit of Confocal Laser Endomicroscopy System at 11301 Wilshire Blvd., Los Angeles, CA 90073, Bldg. 500, 5 East, Pulmonary Endoscopy Lab, inside of Clinical Procedure Unit.
· The Contractor shall ensure all equipment delivered are fully operational to manufacturer’s specification and free from defect.
· The Contractor shall provide delivery, set up, and technical support for clinical staff and clinician training for use the system.
· The Contractor 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 Contractor shall coordinate with VA Supply Chain Management or facility appropriate contact agree upon delivery day and arrival to the facility.
· The Contractor shall provide digital format operation manual include the care, handling, set up, and cleaning instruction on the confocal laser endomicroscopy system.
File details come from the government source that posted it. Updated .