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 goal is to ensure the hospital has functional, up-to-date flow cytometry equipment to support diagnosis and monitoring of hematological conditions such as leukemia, lymphomas, multiple myeloma, and post-transplant assessments.

Scope

The scope encompasses:

• Provision of two (2) fully compliant flow cytometers with all related hardware, software, reagents, consumables, and controls.
• Installation, commissioning, and calibration of the equipment at Inkosi Albert Luthuli Hospital.
• Comprehensive training for staff on operation, maintenance, and troubleshooting.
• Ongoing service, preventative maintenance, repairs, and software updates over five (5) years.
• Provision of reagents, controls, and consumables necessary for routine diagnostic testing, including immunophenotyping, CD34 enumeration, PNH detection, and other specialized assays.
• Adherence to technical specifications and compliance with regulatory standards.

Technical Requirements

The technical specifications include but are not limited to:

• Flow cytometers capable of handling a minimum of 25,000 events per second, with detectors for at least 10 fluorescence channels.
• Ability to analyze multiple parameters simultaneously, including complex immunophenotyping panels, CD34, PNH, MRD, and others.
• Compatibility with Windows 10 or higher operating systems.
• Features such as automated color compensation, sample autoloaders with barcode reading, and software for multiparametric analysis.
• On-board QC data management with Levy-Jennings plots, CVs, SDs, and means.
• Uninterrupted Power Supply (UPS) for at least 60 minutes, surge protection, and remote analysis capabilities.
• Support for electronic data transfer, archiving, and reporting.
• Onsite support with trained engineers and application specialists available within 12 hours.
• Compliance with ISO 13485 and approval by relevant regulatory authorities.
• Provision of reagents, consumables, and controls at the supplier’s cost.

Skills Requirements

The successful bidder must demonstrate:

• Expertise in the supply, installation, and maintenance of flow cytometry systems.
• Proven experience with diagnostic hematology laboratories, particularly in immunophenotyping, CD34 enumeration, and PNH detection.
• Qualified technical personnel with training in flow cytometry operation, troubleshooting, and software management.
• Ability to provide comprehensive training and ongoing technical support.
• Compliance with all regulatory and quality standards, including ISO 13485 certification.
• Capacity to supply reagents, controls, and consumables for routine and specialized tests.
• Demonstrated capability to deliver and support complex laboratory instrumentation over a five-year period.