Objectives

The primary objective is to procure ten (10) units of sterile-packed, cryopreserved human amniotic membranes for use in ophthalmology surgical procedures at Grey’s Hospital. The procurement seeks to secure biologically viable tissue that meets strict clinical standards while complying with national public procurement legislation and preferential scoring frameworks.

Scope

• Item: 2.2cm Cryopreserved Human Amniotic Membrane, sterile packed.
• Quantity: 10 units.
• Delivery Destination: Grey’s Hospital, KwaZulu-Natal Department of Health.
• Contract Nature: Single-supply order with no extended service period.
• Evaluation Structure: Four-stage process: administrative compliance, specification adherence, objective sample verification, and final scoring using an 80/20 price-to-preference ratio.

Technical Requirements

• Product Specifications: Exactly 2.2cm in dimension, cryopreserved human amniotic membrane, supplied in sterile packaging. Items must be new, unused, and retain a minimum shelf life of six months upon delivery.
• Regulatory Documentation: Valid SAHPRA licence permitting manufacture, import, export, or wholesale distribution of medical devices/biologicals. Updated Central Suppliers Database (CSD) registration and verified tax compliance status are mandatory.
• Submission Requirements: Official quotation forms completed in full, SBD 4 (Bidder’s Disclosure), SBD 6.1 (Preference Points Claim Form), and physical samples submitted alongside the initial quotation.
• Pricing & Validity: All-inclusive delivered pricing (VAT inclusive where applicable). Prices must be firm and remain valid for 90 days.
• Quality & Warranty: Must meet sterile quality standards. Supplier warrants goods against defects for twelve (12) months post-delivery or eighteen (18) months from shipment, whichever occurs first.

Skills and Experience Requirements

No specialised clinical or engineering skills are required. Bidders must instead demonstrate:

• Operational capacity to handle and transport temperature-sensitive biological products under controlled cold-chain conditions.
• Proven track record supplying regulated medical or ophthalmic consumables to healthcare institutions.
• Administrative competence to complete mandatory returnable documents accurately and submit within stipulated deadlines.
• Compliance with transformation targets, specifically maintaining ≥51% Black ownership to qualify for preference points.

Explanation of Unusual or Complicated Terms

• Cryopreserved Human Amniotic Membrane: A biological graft harvested from human placental tissue and preserved at ultra-low temperatures to maintain cellular integrity. In ophthalmology, it is applied to promote corneal epithelialisation, reduce post-surgical inflammation, and minimise scarring. Requires uninterrupted cold-chain logistics and aseptic handling.
• SAHPRA Licence: Statutory authorisation from the South African Health Products Regulatory Authority. It certifies that the supplier legally handles regulated medical/biological products and guarantees adherence to national safety, efficacy, and quality benchmarks.
• 80/20 Preference Point System: A government procurement evaluation model allocating 80 points to competitive pricing and 20 points to designated socio-economic goals (here, ≥51% Black ownership). Final awards consider both cost and transformation compliance.
• Sample Verification Stage: An objective technical assessment where top-scoring bidders must physically submit product samples for clinical scrutiny. Non-compliant samples result in immediate disqualification, regardless of prior scoring.