Attachment A - Performance Work Statement.docx
DOCX document 18 KB Posted
- Attached to
- 6515--Confocal Laser Endomicroscopy System Federal contract opportunity
- Solicitation number
- 36C26226Q1363
About this file
This is a Performance Work Statement (PWS) for the procurement of a Confocal Laser Endomicroscopy System for the Department of Veterans Affairs (VA) Greater Los Angeles Healthcare System's Pulmonary Endoscopy Lab.
The PWS outlines the VA's requirements for acquiring a confocal laser endomicroscopy system capable of providing high-resolution, real-time imaging during pulmonary endoscopic procedures. The system must support clinical applications in the pulmonary endoscopy laboratory, enabling enhanced visualization and diagnostic capabilities for lung tissue examination. Key technical requirements include compatibility with standard endoscopy equipment, software functionality for image capture and analysis, system reliability and maintenance support, operator training, and technical documentation. The contractor must provide installation, validation, and commissioning of the equipment at the VA facility, along with comprehensive user training for clinical staff. Post-delivery support requirements include preventive maintenance, repair services, spare parts availability, and technical assistance. The system must comply with applicable federal medical device regulations, safety standards, and VA procurement specifications. Delivery and operational readiness must be achieved within specified timeframes following contract award to ensure the laboratory can commence clinical use of the advanced diagnostic technology.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| 36C26226Q1363_1.docx | DOCX document | |
| Attachment B - Schedule of Pricing.xlsx | XLSX spreadsheet | |
| 36C26226Q1363.docx | DOCX document |
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Text version
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 .