Compliance Framework
HTM 03-01
Health Technical Memorandum 03-01 sets the design, installation, validation and operational requirements for specialised ventilation in healthcare premises – sitting alongside TR19 for clinical estates.
Purpose
HTM 03-01 governs specialised ventilation supporting clinical, theatre, isolation and pharmacy environments. It places explicit duties around annual verification, AE(V) involvement and Authorised Person oversight.
Core requirements
- Annual verification of critical ventilation systems
- Authorised Person (Ventilation) and Authorising Engineer roles
- Validation against design air change rates and pressure regimes
- Documented control of changes and remedial works
- Inspection of cleanliness in line with TR19 principles
Responsibilities
- Trust Board / CEO as the ultimate Duty Holder
- Designated Person – strategic oversight
- Authorised Person (V) – operational management
- Estates and IPC teams – day-to-day operation and assurance
Compliance implications
- Infection control risk where validation lapses
- CQC and NHSE assurance findings
- Operational impact on theatre and clinical capacity
- Estates audit and ERIC reporting exposure
Recommended inspection frequencies
| Risk / classification | Suggested cadence |
|---|---|
| Critical clinical systems | Annual verification |
| Operating theatres | Annual and on intervention |
| Non-critical extract | TR19 risk-based |
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Bring your ventilation systems into TR19 compliance
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- Audit-ready photographic reporting
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