Objectives

The primary objective of this tender is to procure and install an Automated Cell Imaging System at the Dr. George Mukhari Academic Laboratory. The system aims to improve workflow efficiency, reduce manual tasks, and enhance turnaround times for cytogenetic analyses, thereby contributing to better patient outcomes and laboratory performance. The contract includes providing the instrumentation, consumables, maintenance, application support, and training over a period of five years.

Scope

The scope encompasses:

• Provision of the automated cell imaging instrumentation.
• Supply of consumables, reagents, and test kits.
• Installation, commissioning, and calibration of the system.
• Ongoing maintenance and application support for five years.
• Provision of end-user training on operation and maintenance.
• Support for workflow improvement in cytogenetic testing, including FISH and conventional karyotyping.

The expected test volumes include approximately 500 blood and bone marrow karyotypes and 600 FISH tests annually, totaling around 1100 tests per year.

Technical Requirements

The technical specifications and mandatory requirements include:

• High-resolution camera with at least 12 megapixels for image capture and processing.
• Automated microscope capable of scanning, capturing, and analyzing slides.
• Four analysis stations for conventional karyotyping and two for FISH, with software and scanning capabilities.
• Automatic oil dispenser with drop counting.
• Slide capacity exceeding 20 slides.
• Image export functionality.
• Uninterruptible Power Supply (UPS) with a minimum of 60 minutes backup and surge protection.
• Support for software upgrades at no additional cost.
• User training covering operation, maintenance, and testing procedures.
• Compliance with ISO 9001 and ISO 13485 standards.
• Product approval by relevant IMDRF regulatory authorities.

Skills and Service Requirements

The successful bidder must demonstrate:

• Provision of technical and maintenance support, including a call center and application specialists.
• Response times within 4 hours telephonically and on-site within 48 hours.
• On-site end-user training with certification, including initial and ongoing training options.
• Availability of spare parts, with advance notice of termination of production if applicable.
• Provision of warranty for at least 12 months post-delivery, with repair or replacement of defective goods.
• Compliance with occupational health and safety standards, including relevant certifications.
• Adherence to the procurement, quality, and safety standards specified in the tender documentation.

The bidder must also provide evidence of their capacity to support the system, including support infrastructure, trained personnel, and compliance with applicable standards and regulations.