Health Technical Memorandum 03-01 is the principal guidance for specialised ventilation in healthcare premises in England. It applies to ventilation supporting clinical environments – theatres, isolation rooms, pharmacy aseptic suites and similar – and places clear duties on Trusts and providers.
Roles defined by HTM 03-01
- Duty Holder – the Trust Board or equivalent
- Designated Person (Ventilation) – strategic responsibility
- Authorised Person (Ventilation) – operational management
- Competent Person – performing the work under AP(V) oversight
- Authorising Engineer (Ventilation) – independent advisory role
Core compliance requirements
- Annual verification of critical ventilation systems
- Validation against design parameters – air change rates, pressure regimes
- Documented change control and remedial action
- Inspection of cleanliness in line with TR19 principles
Where HTM 03-01 meets TR19
HTM 03-01 governs design, performance and validation. TR19 governs internal cleanliness. In a clinical estate, both apply – validation by HTM 03-01, cleanliness by TR19. Most Trusts manage these as integrated compliance programmes.