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Departmentof HealthHealth Technical Memorandum04-01: Safe water in healthcarepremisesPart A: Design, installation andcommissioning
Health Technical Memorandum04-01 Safe water in healthcarepremisesPart A: Design, installation andcommissioning
Health Technical Memorandum 04-01: Safe water in healthcare premises: Part A – Design, installation and commissioning Crown copyright 2016You may re-use this information (not including logos) free of charge in any format or medium underthe terms of the Open Government Licence. To view this licence,visit cence/ or write to the Information PolicyTeam, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gsi.gov.uk.This document is available from our website -technical-memorandum-disinfection-and sterilizationii
ContentsContentsExecutive summary .ivAcknowledgements.viiGlossary and abbreviations .ix0 Policy and regulatory overview: water safety and the healthcare estate. 11 Introduction To HTM 04-01. 72 Source of supply .133 Materials of construction.184 Water treatment and control programmes for hot and cold water systems . 235 Metal contamination . 276 Water softening . 287 Filtration. 308 Water storage . 319 Cold water distribution system. 4010 Hot water services . 4611 Building management systems . 5712 Pipework installations . 5813 Noise and vibration . 6214 Water economy and energy conservation . 6315 Installation, testing and commissioning . 6416 Documentation. 71Appendix 1 Impact of water consumption on care pathways . 73Appendix 2 Overview of UK water legislation and regulation .74References. 76iii
Health Technical Memorandum 04-01: Safe water in healthcare premises: Part A – Design, installation and commissioningExecutive summaryPreambleThis current review and update of HTM 04-01is intended to move users of the documenttowards a holistic management of watersystems via Water Safety Groups (WSGs),Water Safety Plans (WSPs) and other initiatives.This version draws together and updatesthe previous guidance and includesrecommendations for the safe managementof water systems, via the integration of theprinciple of WSGs and WSPs (first introducedin the HTM 04-01 Pseudomonas aeruginosaaddendum – published in March 2013), andhow to manage and minimise the risks to healthfrom various aspects, ranging from clinicalrisks, microbial and chemical contamination,changes to the water system, resilience of thewater supply etc. It also introduces a strongeremphasis on staff competencies and theimplementation of water hygiene awarenesstraining.IntroductionThe development, construction, installation,commissioning and maintenance of hot andcold water supply systems are vital for publichealth. Healthcare premises are dependentupon water to maintain hygiene and acomfortable environment for patients and staff,and for treatment and diagnostic purposes.Interruptions in water supply can disrupthealthcare activities. The design of systemsshould ensure that sufficient reservewater storage is available to minimise theconsequence of disruption, while at the sametime ensuring an adequate turnover of waterivto prevent stagnation in storage vessels anddistribution systems.This Health Technical Memorandum (HTM)gives comprehensive advice and guidance tohealthcare management, design engineers,estate managers, operations managers,contractors and the supply chain on the legalrequirements, design applications, maintenanceand operation of hot and cold water supply,storage and distribution systems in all types ofhealthcare premises. It is equally applicable toboth new and existing sites.Aims of this guidanceThe current review and update of HTM 04-01is intended to move users of the documenttowards a holistic management of watersystems via WSGs, WSPs and other initiatives.It has been written to promote good practicefor those responsible for the design, installation,commissioning, operation and maintenance ofwater services in healthcare premises, by: highlighting the need for robustgovernance and management; outlining the remit of the WSG and howthis relates to the provision of safe waterin healthcare premises; outlining key criteria and systemarrangements to help stop the ingressof chemical and microbial contaminantsand microbial colonisation and bacteriaproliferation; illustrating temperature regimes forsanitary outlets to maintain waterhygiene;
Executive summary ensuring the safe delivery of hot water; outlining how the correct selection ofsystem components and correct use byoccupants can help preserve the qualityand hygiene of water supplies;colonisation of other waterborne organismswithin water systems. To prevent growth of P.aeruginosa and other waterborne pathogens,controls are necessary to manage the watersystem before and after the outlet. providing a point of reference tolegislation, standards and other guidancepertaining to water systems;As with all control measures, temperaturesshould be monitored at regular intervals toverify effective control. providing a basic overview of possiblepotential waterborne pathogens; giving an overview of some of thedifferent water systems (includingcomponents) and their safe installation,commissioning and operation andmaintenance; providing typical system layouts andindividual component location; providing information on thermostaticmixing valve configurations, appropriateusage and maintenance requirements; identifying key commissioning, testingand maintenance requirements forreferral by designers, installers, operatorsand management; identifying key commissioning, testingand maintenance requirementsfor referral by designers, installers,commissioners, operators andmanagement.Controlling waterborne pathogensThe guidance gives comprehensive guidanceon measures to control waterborne pathogens.While Legionella control is, in the main,associated with poor engineering configurationand maintenance, with no evidence of patient to-patient or patient-to-outlet transfer, P.aeruginosa may be transferred to and fromoutlets and the water from both patients andstaff. Suspected P. aeruginosa waterborneinfections require additional investigations todetermine the source and interventions frominfection control specialists and microbiologists.Therefore, a temperature control regime is thetraditional strategy for reducing the risk fromLegionella and for reducing the growth andBecause of the complexity of hot and coldwater distribution systems and the difficultyof maintaining a temperature control regimein some healthcare facilities, this guidancesuggests that additional chemical, physicaland other water control methods that havebeen shown to be capable of controllingmicrobial colonisation and growth may also beconsidered.Main changes from the 2006edition of HTM 04-01 This 2016 edition of HTM 04-01 providescomprehensive guidance on measuresto control waterborne pathogenssuch as Pseudomonas aeruginosa,Stenotrophomonas maltophilia,Mycobacteria as well as Legionella. This edition has been updated to alignwith the Health and Safety Executive’s(HSE’s) recently revised ApprovedCode of Practic e for Legionella (L8)and its associated HSG274 guidancedocuments. The Addendum to HTM 04-01 publishedin 2013 (and now Part C of HTM 04-01)introduced the concept of WSGs andWSPs. Part B of the HTM now includesupdated guidance on the remit and aimsof the WSG and WSP. New guidance has been included on thehygienic storing and installation of fittingsand components and on the competencyof installers/plumbers working onhealthcare water systems. The guidancealso outlines that any person working onwater distribution systems or cleaningwater outlets needs to have completed av
Health Technical Memorandum 04-01: Safe water in healthcare premises: Part A – Design, installation and commissioningwater hygiene awareness training course.An example course outline is included. Guidance on sampling techniques for,testing for, and the microbiologicalexamination of Pseudomonas aeruginosasamples – originally in the HTM 04-01Addendum – is now included in PartB to complement similar guidance onLegionella.vi
AcknowledgementsAcknowledgementsThe Department of Health would like to thank the Steering Group for theiradvice and support, and all those who contributed to the consultationphase of the document:Christian Taylor-Hamlin Bathroom Manufacturers AssociationDavid Way BEAMADavy Burns Health Estates, Northern IrelandElise Maynard Water Management SocietyGeorge McCracken Belfast Health & Social Care TrustGraham Thompson Water Management SocietyIan Storrar Health Facilities ScotlandJimmy Walker Public Health EnglandJohn Newbold Health & Safety ExecutiveLorraine Medcalf Health & Safety ExecutiveMark Gapper NHS Wales Shared Services PartnershipMike Arrowsmith Arrowsmith and AssociatesMike Kelsey Whittington Hospital, LondonMike Weinbren Chesterfield Royal Hospital NHS Foundation TrustNick Hill Institute of Healthcare Engineering and Estate Management (IHEEM)Paul Millard Water Regulations Advisory Scheme (WRAS)Paul Taylor NSF/BuildCertPaul Weaving Infection Prevention SocietyPhil Ashcroft Department of HealthReginald Brown BSRIARobert Pitchers WRcSimon Benton Drinking Water InspectorateSusanne Lee Royal Society for Public HealthTom Makin Envirocloud LtdTom Makin senior Makin and Makin Consultancy Ltdvii
Health Technical Memorandum 04-01: Safe water in healthcare premises: Part A – Design, installation and commissioningviii
Glossary and abbreviationsGlossary and abbreviationsIn addition to the definitions listed below, otherdefinitions can be found in the Water Supply(Water Fittings) Regulations 1999; BS 6100;BS 8558; and BS EN 806.Augmented care units/settings – There is nofixed definition of “augmented care”; individualproviders may wish to designate a particularservice as one where water quality must be of ahigher microbiological standard than that providedby the supplier. While this document providesbroad guidance, the water quality required willbe dependent on both the type of patient andits intended use. Most care that is designated asaugmented will be that where medical/nursingprocedures render the patients susceptibleto invasive disease from environmental andopportunistic pathogens such as Pseudomonasaeruginosa and other alert organisms. In broadterms, these patient groups will include:a. those patients who are severelyimmunosuppressed because ofdisease or treatment: this will includetransplant patients and similar heavilyimmunosuppressed patients duringhigh-risk periods in their therapy;b. those cared for in units where organsupport is necessary, for examplecritical care (adult paediatric andneonatal), renal, respiratory (mayinclude cystic fibrosis units) or otherintensive care situations;c.those patients who have extensivebreaches in their dermal integrity andrequire contact with water as part oftheir continuing care, such as in thoseunits caring for burns.Backflow – Flow upstream, that is in adirection contrary to the intended normaldirection of flow, within or from a water fitting.Biofilm – a complex layer of microorganismsthat have attached and grown on asurface. This form of growth provides aniche environment for a wide range ofmicroorganisms to interact and where thesecretion of exopolysaccharides by bacteriawill form an extracellular matrix for bothbacteria and other unicellular organisms suchas amoebae and flagellates to remain in aprotected state.Dead-leg – a length of water system pipeworkleading to a fitting through which water onlypasses infrequently when there is draw off fromthe fitting, providing the potential for stagnation.Healthcare-associated infections (HCAI) –encompasses any infection by any infectiousagent acquired as a consequence of a person’streatment or which is acquired by a healthcareworker in the course of their duties.Healthcare facility/building – all buildings,infrastructure, equipment, plant, embeddedsystems and related items that support thedelivery of healthcare and services of all types,irrespective of their ownership or operation bythird parties.Healthcare organisations: organisations thatprovide or intend to provide healthcare servicesfor the purposes of the NHS.Point-of-use (POU) filter – a filter with amaximal pore size of 0.2 μm applied at the outlet,which removes bacteria from the water flow.ix
Health Technical Memorandum 04-01: Safe water in healthcare premises: Part A – Design, installation and commissioningRedundant pipework (also known as blindend): a length of pipe closed at one endthrough which no water passes.Thermostatic mixing valve: valve with oneoutlet, which mixes hot and cold water andautomatically controls the mixed water to auser-selected or pre-set temperature.Waterborne pathogen: microorganismcapable of causing disease that may betransmitted via water and acquired throughingestion, bathing, or by other means.Wholesomeness: standards of wholesomeness are defined in section 67 of the WaterIndustry Act 1991. Separate legislation for publicand private supplies sets out the prescribedconcentrations and values for water and aredetailed in the following legislation: the WaterSupply (Water Quality) Regulations 2000 forwater from a public supply; or the Private Water Supplies Regulations 2009 for water from aprivate supply.List of abbreviationsWater outlet: (In this document) refers mainlyto taps and showerheads, but other outlets, asindicated by risk assessments, may beconsidered important.COSHH – Control of Substances Hazardous toHealth [Regulations]Water Safety Group (WSG): Amultidisciplinary group formed to undertake thecommissioning and development and ongoingmanagement of the water safety plan (WSP). Italso advises on the remedial action requiredwhen water systems or outlets are found to becontaminated and the risk to susceptiblepatients is increased.DWI – Drinking Water InspectorateWater safety plan (WSP): A risk-managementapproach to the safety of water that establishesgood practices in local water distribution andsupply. It will identify potential hazards, considerpractical aspects, and detail appropriate controlmeasures.Water supply [to the healthcare facility]:The water supplied can be via:EA – Environment AgencyEPDM – ethylene propylene diene monomerHBN – Health Building NoteHSE – Health & Safety ExecutiveHSG274 Part 2 – The Health & SafetyExecutive’s technical guidance on the control ofLegionnaires’ disease in hot and cold watersystemsHTM – Health Technical MemorandumPOU – point of use the mains water supply from the localwater undertaker;PWTAG – Pool Water Treatment AdvisoryGroup a borehole (operated by the healthcareorganisation as a private water supply);SHTM – Scottish Health TechnicalMemorandum a combination of mains water andborehole supply; emergency water provision (bulk tankeredwater or bottled drinking water).Water undertaker – the role of a waterundertaker is defined in a number of sections ofthe Water Industry Act 1991.xCQC – Care Quality CommissionUKWIR – UK Water Industry ResearchWRAS – Water Regulations Advisory SchemeWSG – Water Safety GroupWSP – Water safety plan
0 Policy and regulatory overview: water safety and the healthcare estate0 Policy and regulatory overview: water safetyand the healthcare estateIntroduction0.1 The National Health Service (NHS) hasa corporate responsibility to account for thestewardship of its publicly funded assets.This includes the provision, managementand operation of an efficient, safe estate thatsupports clinical services and strategy.0.2 This corporate responsibility is carriedby all accountable officers, directors withresponsibility for estates & facilities and theirequivalents, chairs, chief executive officers andnon-executive board members. Together theyhave a responsibility to enact the principlesset out in this document, provide leadershipand work together to implement the necessarychanges to provide a safe, efficient high qualityhealthcare estate.0.3 To achieve this, quality and fitness-for purpose of the healthcare estate is vital. HealthTechnical Memorandum (HTM) 04-01 seeks toset out the quality of, and standards for, watersafety in the healthcare estate.0.4 A healthcare organisation’s Water SafetyGroup (WSG) (see Part B) is pivotal in ensuringthat decisions affecting the safety andintegrity of the water systems and associatedequipment do not go ahead without beingagreed by them. This includes consultationsrelating to decisions on the procurement,design, installation and commissioning of waterservices, equipment and associated treatmentprocesses.0.5 The quality and fitness-for-purpose ofthe estate are assessed against a set of legalrequirements and governance standards.Adhering to the guidance outlined in this HTMwill be taken into account as evidence towardscompliance with these legal requirements andgovernance standards.Compliance of the healthcare estate0.6 Principles related to the safety ofhealthcare estates and facilities are enshrinedin the Health and Social Care Act 2008(Regulated Activities) Regulations 2014,specifically Regulation 12(2)(h) and Regulation15 of the Act.NoteThere are numerous other statutes andlegal requirements that NHS organisations,supporting professionals, contractors andsuppliers must comply with. These arecovered in the respective Health BuildingNotes (HBNs), Health Technical Memoranda(HTMs) and the NHS Premises AssuranceModel (NHS PAM).Health and Social Care Act 2008(Regulated Activities) Regulations20140.7 Regulation 12(2)(h) decrees that registeredproviders must assess: the risk of, and prevent, detect andcontrol the spread of, infections,including those that are health careassociated.1
Health Technical Memorandum 04-01: Safe water in healthcare premises: Part A – Design, installation and commissioning0.8 Appropriate standards of cl
(Water Fittings) Regulations 1999; BS 6100; BS 8558; and BS EN 806. Augmented care units/settings – There is no ixed deinition of “augmented care”; individual providers may wish to designate a particular service as one where water quality must be of a higher microbiological standard than that provided by the supplier.
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