Objectives

The primary objective of this tender is to procure and establish a system for the placement of an automated stainer and glass coverslips, including comprehensive service, maintenance, and repairs, for a period of five (5) years at Inkosi Albert Luthuli Central Hospital (IALCH) Anatomical Pathology. The goal is to improve laboratory turnaround times, facilitate faster reporting of patient cases, and enhance operational efficiency in histopathology staining processes.

Scope

The scope encompasses the supply, installation, commissioning, and ongoing service of an automated staining system with integrated glass coverslipping capabilities. It includes:

• Provision of the automated stainer and glass coverslips as per technical specifications.
• Comprehensive maintenance, repairs, and service support over five years.
• Training of laboratory personnel on system operation and maintenance.
• Ensuring system integration with existing laboratory information systems where applicable.

The scope also covers all associated modules, consumables, and accessories necessary for continuous operation, as well as compliance with technical and regulatory standards.

Technical Requirements

The technical specifications include, but are not limited to:

• High-capacity processing: capable of staining up to 300 H&E slides per hour, including coverslipping.
• Continuous sample loading with multi-staining capability and concurrent operation.
• Integrated glass coverslipping system with slide breakage protection, accepting slides of varying thickness and compatible with mountants like DPX.
• Drying oven stations: minimum of three, with reliable operation.
• System interoperability: fully automated and integrated between the stainer and glass coverslipper.
• Liquid level sensing with low reagent warning features.
• Adjustable mountant volumes and flexible programming for changing staining protocols.
• Compliance with ISO13485 standards and approval by IMDRF regulatory authorities.
• Provision of backup power (UPS) with at least 30 minutes operational capacity and surge protection.

Skills and Skills Requirements

The successful bidder must demonstrate:

• Expertise in the supply and installation of automated histopathology staining systems.
• Capability to provide comprehensive training, including initial, retraining, and refresher courses, for laboratory staff.
• Assessment and certification of personnel in system operation and quality assurance.
• Availability of technical support, maintenance, and repair services within 24 hours.
• Provision of all modules, consumables, and spare parts necessary for uninterrupted operation.
• Experience in working with laboratory information systems and ensuring system integration.
• Compliance with regulatory standards and certification requirements.
• Ability to provide detailed technical documentation, manuals, and ongoing support.

The bidder must also possess the capacity to deliver on all technical and service requirements, including adherence to safety, quality, and regulatory standards, ensuring system reliability and sustainability over the five-year period.