Objectives

The primary objective is to procure and supply high-quality, compliant infant oxygenator combo packs to support paediatric cardiac surgical procedures at the designated provincial hospital facility. The procurement also aims to promote economic transformation by allocating preferential procurement points to youth-owned enterprises while ensuring reliable access to specialised medical equipment.

Scope

This is a one-off goods supply contract covering the delivery of fifteen (15) units of Infant Oxygenator Combo Packs to Inkosi Albert Luthuli Central Hospital. Quotations must remain valid for ninety (90) days. All pricing must be firm, inclusive of delivery costs to the specified destination, and compliant with applicable taxes. The procuring entity reserves the right to accept or reject any quotation and is not obligated to award the contract to the lowest bidder.

Technical Requirements

• Product Specifications: Transparent polyvinylchloride (PVC) construction, packaged in boxes, specifically sized for infant patients.
• Functional Performance: Must ensure efficient oxygenation with a small priming volume, an integrated heat exchanger, and a flow range of 0–1500 ml. The system must allow straightforward setup, priming, and de-airing, with optimum transmembrane pressures during bypass and maintained Shore hardness during temperature fluctuations.
• Configuration Flexibility: Tubing packs must align with provided technical drawings. If the oxygenator includes an integrated arterial filter, an external filter may be omitted. Pre-bypass filters are optional.
• Quality & Compliance: Items must be brand new, unused, and possess a minimum shelf life of six months upon delivery. Full compliance with all listed specifications is mandatory; incomplete specification checklists will result in disqualification.
• Regulatory Approval: Suppliers must hold a valid licence from the South African Health Products Regulatory Authority (SAHPRA) permitting the import, export, manufacture, or wholesale distribution of medical devices.

Skills and Qualification Requirements

• Administrative & Financial Compliance: Active registration on the Central Supplier Database (CSD), valid tax clearance status, and submission of updated CIPC registration documents or a sworn B-BBEE affidavit.
• Operational Capacity: Demonstrated ability to deliver medical supplies without prior unexcused defaults. Bidders must prove logistical and operational capacity to fulfil the order within agreed timeframes.
• Preferential Procurement Eligibility: To claim the twenty (20) preference points allocated for youth-owned enterprises, bidders must provide verifiable proof of youth ownership via B-BBEE documentation or CSD reports.
• Sample Provisioning: Shortlisted bidders may be required to submit physical product samples for objective evaluation and specification verification.

Notable Terms and Conditions

Infant Oxygenator Combo Pack: This refers to a specialised extracorporeal circuit combining an oxygenator and associated tubing pack, engineered specifically for cardiopulmonary bypass procedures in infant cardiac surgery. It requires strict adherence to medical device safety, biocompatibility, and performance standards.

Evaluation Framework: Quotations undergo a five-stage assessment covering administrative compliance, delivery capacity, specification adherence, price/preference scoring (80/20 system), and sample verification. Failure at any stage results in immediate disqualification.

Contractual Obligations: Successful bidders must adhere to standard General and Special Conditions of Contract, including a twelve-month warranty from delivery acceptance, potential performance security requirements within thirty days of award, and penalties for delayed delivery calculated at the current prime interest rate.