Tender Summary

Objectives

The primary objective is to procure a qualified service provider to conduct five (5) particle count assessments in the operating theatre at the designated hospital. The engagement aims to verify that the theatre environment meets stringent sterility and air quality standards required for safe surgical procedures. Additionally, the procurement aligns with national preferential procurement policies, prioritizing South African-owned enterprises through a structured scoring system.

Scope

This is a once-off contract covering the execution of particle count testing within the theatre facility. The scope includes on-site testing, data collection, analysis, and submission of compliant reports aligned with the attached technical specification. The successful bidder may be required to submit physical samples if ranked among the top scorers during evaluation. All activities must be performed at the procuring institution’s premises and governed by the stipulated General and Special Conditions of Contract. Pricing must be firm, inclusive of all delivery and incidental costs, and valid for ninety days.

Technical Requirements

• Strict compliance with the attached specification document outlining acceptable parameters, methodologies, and reporting formats for theatre particle counts.
• Valid licence issued by the South African Health Products Regulatory Authority (SAHPRA) is mandatory if the service involves the use, distribution, or manufacture of regulated medical devices or associated equipment.
• Submission of at least one verified delivery note or invoice demonstrating prior experience supplying similar environmental monitoring services to public or private health facilities.
• Compliance with baseline contractor grading (noted as CIDB 2EB and above, reflecting a standardised capability threshold).
• Full completion and submission of all mandatory administrative and compliance documentation, including Central Supplier Database (CSD) registration, updated CIPC company documents, B-BBEE status verification, and SARS tax clearance certificates.
• All products and services must conform to relevant South African National Standards (SANS/SABS) where applicable. Expired goods, second-hand items, and non-firm pricing structures are strictly prohibited.

Skills Requirements

• Demonstrated expertise in environmental monitoring and airborne particulate measurement specifically within surgical or controlled healthcare environments.
• Proficiency in operating calibrated laser particle counters and interpreting results against established healthcare sterility benchmarks.
• Ability to generate accurate, audit-ready reports and maintain proper chain-of-custody protocols for test data.
• Proven track record of delivering comparable services within public or private health facility supply chains, substantiated by historical delivery records.
• Working knowledge of regulatory compliance frameworks governing medical device usage, healthcare environmental standards, and municipal health safety protocols.

Notes on Technical Terms

Particle Counts in Theatre: Refers to the measurement of airborne particulate matter (typically ≥0.5µm and ≥5.0µm) in operating rooms to ensure they meet international sterility classifications (e.g., ISO Class 5 or equivalent healthcare guidelines). This testing verifies HVAC filtration efficiency and maintains a contamination-controlled environment essential for surgical safety.

SAHPRA Licence: Issued by the South African Health Products Regulatory Authority, this licence authorises entities to legally manufacture, wholesale, or distribute medical devices and related health products in South Africa. Its inclusion ensures that any equipment or consumables used during testing comply with national health product regulations.

80/20 Preference Point System: A standard public procurement scoring model where eighty percent of evaluation points are allocated to price competitiveness and twenty percent to specific socio-economic goals, such as promoting South African-owned enterprises.