UK Experience with HTM-03 and Preventing Bio-contamination in Hospital OTs Richard Knight CEng, MCIBSE, FIHEEM Connolly Memorial Hospital, Blanchardstown, Dublin 1 st December 2016 Content Objectives Basis for HTM 03 and earlier HTM HTM 03 strategy Validation Quarterly inspection and annual verification Ventilation group Governance Training 1
Objective Minimise infection risk amongst others, including: Chemical risk Fire Static shock Clinical errors Poor productivity Objective HTM 03-01 has particular performance requirements for new or refurbished medical facilities, including theatres followed by regular and annual inspections to demonstrate the system is still working correctly and if not what remedial work would be needed to bring the system back into safe operation 2
Evidence base The base is strong utilising what became very structured research carried out by: Lidwell, Lowbury, Whyte, Blowers, Stanley, Lowe, etc. Collectively perhaps 100 or so research papers Beggs Ljungqvist Reinmuller Fletcher Noakes Etc. A little more recently 3
Ventilation strategies Dilution ventilation Air filtration Pressure cascade Cross flow ventilation Uni directional ventilation Open door protection Beneficial effect of effective dilution ventilation Bacterial sampling of UCV 4
Clothing Persons present Other factors effecting bio-contamination From adjacent spaces Enclosing or semi enclosing the wound site Working practices Dust and dirt, in the medical location Materials, already in the medical location Chemical risk Fire risk Static shock Clinical errors Some non medical risks Poor productivity Fire Ventricular fibrillation CIBSE TM 40:2006 Health issues in building services 5
Validation strategy Empty theatres would be easier to test, as there would be no need to mockup say the surgical team or have the lights at just the right angle, and how do you set up the screen(s) or pendants? Therefore at the time of the research empty theatres also had there performance measured. Validation strategy The objective of the HTM is to robustly test the correct operation of the ventilation systems and at least as important for these to be carried out reliably 6
Validation Validation. A process of proving that the system is fit for purpose and achieves the operating performance originally specified. It will normally be a condition of contract that The system will be acceptable to the client if at the time of validation it is considered fit for purpose and will only require routine maintenance in order to remain so for its projected life. from the HTM Periodic inspection Objective to ensure the ventilation system remains safe for patient and staff using the theatre or medical location 7
Monthly PPM To make basic checks and minor repairs: Based on BESA SFG 20 not Health specific but in effect required by HTM as it is additional to other standards Quarterly inspection Objective to carry out more in depth checks and carry out minor adjustments and repairs: AHU checks, Fabric and facility checks, Fire inspections, Repairs and remedial works, Monitoring of remedial works/repairs/all plant/completed to time. 8
Annual inspection or verification Objective to carry out more in depth checks and carry out minor adjustments and repairs, generating a formal report: AHU checks, Theatre and facility checks, Fire inspections, Repairs and remedial works, Monitoring of works/ repairs/all plant/completed to time. Dirty theatres Common, not remotely limited to the UK 9
Dirty Dirty Dirty Dirty More dirty photos This time below 2m the more dust in the medical locations the less well the ventilation will perform as there is so much dust in the rooms 10
Cleaning audits General in nature, Tick box, Little detail 3hrs So in effective monitoring tool Does and did not pick up Cleaner insufficient training on what needs to be cleaned Cleaner had insufficient time to clean Much medical equipment needed to be moved increasing time needed to clean Poor microbiological sampling Repeated fails, on effectively unaltered system, following retest HTM gives clear guidance, failure here is not following the guidance Other examples of fails: and poor practice from using wrong media, The self sampler, plates directly on floor and walking around. 11
Damaged filters Applicable to all filters not just bag filters Standard requires correctly installed filters, failure, ability and effective monitoring system Leaking filters Problem leaks onto patient Picked up by safety system Root cause, not clear Evidence being gathered 12
Challenge testing filters Not, fully testing for leaks around filters Not testing or being able to test the upstream concentration Smoke generator DOP injection Dirty ducts new or existing The HTM has a defence against this requiring the duct work to be clean to BESA TR19:2013 Failure here is not the standard, but competency, this was at least the third time this system was cleaned, Hardly ever recorded in commissioning, validation or verification reports and failure to monitor 13
An inappropriate use of a Theatre From UK campaign video for WHO Surgical Safety Checklist Accessed 08/04/2014 and 29/11/2016 14
Filter bio contamination From non compliant filters HTM requires compliant filters, so failure to install, pick up in validation and verification Non compliant is problem of competence and monitoring So if non compliant filters used, there is no bench mark, so operator of system cannot demonstrate patient is in safe environment Compliant Filter bio contamination From leaks around the filter frame Non compliant From the junction between the frame of the filter housing and the side of the AHU From new! Compliant 15
Filter bio contamination From gaps between filter and seal, when the frame and seal are too large Also not the most complete seal Cooling coil Seems to be operating better as a fly filter In lieu of an effective pre filter Note many more particles will be getting through as there is a gap in the secondary filter. 16
Dirty AHU Dirty AHU after pre filter indicating burst filters in past and or air by-passing round pre filters, requiring additional revenue expenditure and down time to carry out additional AHU cleaning Chemicals/disinfectant in ventilation systems Cleaned with a atomised spray and not cleared away Allowing maximum time to advance the corrosion of the duct and provide lots of homes for the bugs! Same duct run, but contractor forgot to clean the duct, see dust visible particularly on the top of the duct 17
Any one for a swim So required by the HTM, but not captured in verification etc. failure competence and monitoring The verification (or validation) report should ask and answer Is there a statement regards Legionella risk? (3.1) -ve Air Flow Direction - Fan -ve If the trap dries out the flood can occur Wet secondary filters A perfect example of these, Note wet filters are not as effective at filtering as many of the solids, dissolve into solution many passing through the filter Delivered express delivery to the patient! So required by the HTM, but not captured in verification etc. failure competence and monitoring 18
Evidence of wet filters This picture shows evidence of water after the recuperator When water evidence is discovered up to and after the recuperator this is normally carry over of rain water from outside. Though it is possible this could be from water dropping out in the summer when cooling and the heater is controlled to off (no drain fitted) Another reason for installing bag filters correctly from original supply and commissioning Why wet secondary filters Secondary heater controlled off or in effective Simplified Air Conditioning AHU component response lines High Moisture content Hot low moisture content Cold low moisture content Frost Recuperator Heater Humidifier Heater Chiller Room Chiller Recuperator Recuperator 43 19
As seen in many operating theatres near you! This is what is inside Some dusty bits in theatre 20
Now for the keyboards Its all on the finger! The office, sorry operating room And somewhere for the small change and raffle tickets! And the moisturiser is needed because of the much drier atmosphere in theatres than the offices, during the winter months, because the humidifiers have been turned off 21
Some times the mugs are left for a very long time! Its a store! The sign says operating theatre How are these cleaned every day How are these medical devices protected from blood splatter etc. and how are they guaranteed to be cleaned before they might be used on what might be the next patient 22
Cooling coil water eliminators Need to be easily removable and given a good clean Cooling coil drip tray Cannot be removed of cleaned as there is no space, needs resolution See if it can be made removable 23
Wet pre filters? Reasons why And how to resolve Wet pre filters Common problem Results in saggy filters Wet filters BS EN 779 filters are not tested in high humidity atmospheres such as fog or when wet Filters lose their effectiveness when wet 24
Desired Output Extended filter life Reduced cleaning of AHU Reduced risk to patients Thereby achieving compliance with the workplace regulations 2013 (and 1992) Reg 5 provision of fresh or purified air. Wet pre filters Solution fog coils These are often confused with frost coils, they are the same, physical component in the AHU. They are just controlled in a different way In some standards these words are interchanged when describing the control and attributes for the operation of frost coils. 25
Fog coil controls Wet filters Common: In high humidity conditions common nearly all over the world Operation: When the outside (on condition) humidity is very high above 90%RH, the coil is operated to raise the temperature by a few degrees, to re-absorb Burj-Khalifa Dubai the water into the supply air stream Fog coil operation Simply heating the air by a few degrees effectively reabsorbs the mist/fog or any liquid water present in the inlet to the AHU Two examples shown to illustrate operation Suggested off coil humidity 70%PS 26
Fog coil operation at very low temperatures The correct operation of the frost coil control at very low temperatures will cause water, fog or freezing fog to be absorbed into the air stream before it reaches the pre filter. Therefore the filter cannot get wet and collapse or become blocked by frost/ice Fog protection Output Extended filter life Reduced cleaning of AHU Reduced risk to patients Conclusion Very very small increase in capital cost Reduced patient risk Reduced revenue expenditure, reduced rust, wet filters etc Increased life of AHU 27
UK Experience with HTM-03 and Preventing Bio-contamination in Hospital OTs Ventilation systems Conclusions Engineering controls, The HTM does on the whole provide these People behaviour, there are serious problems with competence, knowledge, monitoring, basic quality systems Ongoing cleaning and decontamination, these are very similar, need to concentrate on doing it, and monitoring it 28
Engineering controls, Solutions There may be more need to regulate Impose formal legal duties on all Retaining guidance, improving regulation, placing legal duties, which ever route is taken detailed peer reviewed, evidence based, guidance is needed Conclusions Engineering controls, The HTM does on the whole provide these People behaviour, there are serious problems with competence, knowledge, monitoring, basic quality systems Ongoing cleaning and decontamination, these are very similar, concentrating on doing it, and monitoring it Clearly a need for effective training, monitoring, governance 29
And in other countries? Conclusion very similar Engineering controls, most countries have little or none in place People behaviour, very similar, no significant differences Ongoing cleaning and decontamination, very similar, no significant differences Monitoring Design Validation procedure Delivery Validation Maintenance Verification process Performance If any of the above is missing, we are missing it for the patient 30
What is this guy on!! PDF and Slides Richard Knight Richard Knight Mobile 077 949 14 211 Email millham.orchard@tiscali.co.uk Thank you 31