Objectives

The primary objective of this tender is to procure and install two (2) flow cytometers at Inkosi Albert Luthuli Hospital, including comprehensive service and maintenance for a period of five (5) years. The aim is to enhance diagnostic capabilities for hematological conditions such as leukemia, lymphomas, multiple myeloma, and bone marrow transplants, ensuring reliable operation of essential laboratory equipment.

Scope

The scope encompasses:

• Supply, installation, and commissioning of two (2) flow cytometers compatible with existing laboratory IT infrastructure.
• Provision of all related hardware, software, reagents, consumables, and controls necessary for routine diagnostic testing.
• Training of laboratory personnel on operation, maintenance, and troubleshooting of the equipment.
• Comprehensive service, maintenance, and software updates over five (5) years.
• Adherence to technical specifications outlined in Annexure A, including immunophenotyping panels, antibody reagents, and data management capabilities.

Technical Requirements

The technical specifications include, but are not limited to:

• Flow cytometer with at least 10-color fluorescence detection capability.
• Throughput capacity of a minimum of 20 tubes per hour and ability to count at least 1 million events for MRD analysis.
• Compatibility with Windows 10 or higher operating systems.
• On-board quality control data management with CVs, SDs, and Levy-Jennings plots.
• Automated colour compensation software with spectral overlap correction.
• Fluidics system with adjustable flow rate.
• Uninterrupted Power Supply (UPS) supporting at least 60 minutes operation.
• Provision for remote analysis, data archiving, and interface with NHLS Laboratory Information System (LIS).
• On-site support within 4 hours, including training and documentation.
• Compliance with ISO 13485 and approval by relevant regulatory authorities.

Skills and Skills Requirements

The bidder must demonstrate:

• Proven experience in supplying and maintaining flow cytometry systems, especially in clinical diagnostic laboratories.
• Technical expertise in immunophenotyping, antibody panel validation, and data analysis software.
• Qualified personnel trained in operation, calibration, troubleshooting, and maintenance of flow cytometers.
• Capability to provide ongoing technical support, software updates, and training during the contract period.
• Compliance with quality standards, including ISO 13485 certification and approval by relevant health authorities.
• Ability to integrate with existing laboratory information systems and support multiparametric analysis.
• Demonstrated capacity for timely service response and availability of spare parts.