DH HTM 0401 PART B Acc
DH HTM 0401 PART B Acc
DH HTM 0401 PART B Acc
of Health
Part B: Operational
management
Health Technical Memorandum
04-01: Safe water in healthcare
premises
Part B: Operational
management
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
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Executive summary....................................................................................................................iv
Acknowledgements....................................................................................................................vi
Glossary and abbreviations......................................................................................................vii
0 Policy and regulatory overview: water safety and the healthcare estate......................... 1
1 Introduction.......................................................................................................................... 7
2 Governance and management responsibility.................................................................... 9
3 Statutory requirements......................................................................................................12
4 Legionella: overview...........................................................................................................15
5 Pseudomonas aeruginosa and other waterborne pathogens: overview.........................19
6 Operational management.................................................................................................. 22
7 Description of systems, operational considerations and requirements......................... 38
8 Other operational considerations..................................................................................... 49
9 Microbiological monitoring............................................................................................... 53
10 Testing for Legionella........................................................................................................ 54
Appendix A Examples of the use of water within a healthcare facility and water quality
types......................................................................................................................................... 60
Appendix B Action in the event of an outbreak of legionellosis............................................ 64
Appendix C Exemplar temperature test sheets...................................................................... 65
Appendix D Testing for P. aeruginosa..................................................................................... 67
Appendix E Water sampling for P. aeruginosa........................................................................74
Appendix F Microbiological examination of water samples for P. aeruginosa..................... 77
References................................................................................................................................ 82
iii
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Executive summary
v
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Acknowledgements
The Department of Health would like to thank the Steering Group for their
advice and support, and all those who contributed to the consultation
phase of the document.
Christian Taylor-Hamlin Bathroom Manufacturers Association
David Way BEAMA
Davy Burns Health Estates, Northern Ireland
Elise Maynard Water Management Society
George McCracken Belfast Health & Social Care Trust
Graham Thompson Water Management Society
Ian Storrar Health Facilities Scotland
Jimmy Walker Public Health England
John Newbold Health & Safety Executive
Lorraine Medcalf Health & Safety Executive
Mark Gapper NHS Wales Shared Services Partnership
Mike Arrowsmith Arrowsmith and Associates
Mike Kelsey Whittington Hospital, London
Mike Weinbren Chesterfield Royal Hospital NHS Foundation Trust
Nick Hill Institute of Healthcare Engineering and Estate Management (IHEEM)
Paul Millard Water Regulations Advisory Scheme (WRAS)
Paul Taylor NSF/BuildCert
Paul Weaving Infection Prevention Society
Philip Ashcroft Department of Health
Reginald Brown BSRIA
Robert Pitchers WRc
Simon Benton Drinking Water Inspectorate
Susanne Lee Royal Society for Public Health
Tom Makin Envirocloud Ltd
Tom Makin senior Makin and Makin Consultancy Ltd
vi
Glossary and abbreviations
In addition to the definitions listed below, other b. those cared for in units where organ
definitions can be found in the Water Supply support is necessary, for example
(Water Fittings) Regulations 1999; BS 6100; BS critical care (adult paediatric and
8558; and BS EN 806. neonatal), renal, respiratory (may
include cystic fibrosis units) or other
Alert organisms: Alert organisms are intensive care situations;
microorganisms that have the potential to cause
harm and disease in individuals and which can c. those patients who have extensive
cause an outbreak of infection in a hospital breaches in their dermal integrity and
environment. An alert organism is identified by require contact with water as part of
the microbiology laboratory and referred to the their continuing care, such as in those
infection prevention and control (IPC) team for units caring for burns.
assessment of possible healthcare-associated
acquisition and to identify any possible Backflow – Flow upstream, that is in a
environmental/equipment sources. direction contrary to the intended normal
direction of flow, within or from a water fitting.
Augmented care units/settings – There is no
fixed definition of “augmented care”; individual Biofilm: A biofilm is a complex layer of
providers may wish to designate a particular microorganisms that have attached and grown
service as one where water quality must be on a surface. This form of growth provides
of a higher microbiological standard than that a niche environment for a wide range of
provided by the supplier. While this document microorganisms to interact and where the
provides broad guidance, the water quality secretion of exopolysaccharides by bacteria
required will be dependent on both the type will form an extracellular matrix for both
of patient and its intended use. Most care bacteria and other unicellular organisms such
that is designated as augmented will be that as amoebae and flagellates to remain in a
where medical/nursing procedures render the protected state.
patients susceptible to invasive disease from
environmental and opportunistic pathogens Colony forming unit: Unit that gives rise to
such as Pseudomonas aeruginosa and other a bacterial colony when grown on a solid
alert organisms. In broad terms, these patient medium; this may be a single bacterial cell or a
groups will include: clump of cells.
a. those patients who are severely Dead-leg – a length of water system pipework
immunosuppressed because of leading to a fitting through which water only
disease or treatment: this will include passes infrequently when there is draw-off from
transplant patients and similar heavily the fitting, providing the potential for stagnation.
immunosuppressed patients during
high-risk periods in their therapy;
vii
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
List of abbreviations
cfu – colony forming units
EA – Environment Agency
POU – point-of-use
ix
0 Policy and regulatory overview: water safety and the healthcare estate
1
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
0.8 Appropriate standards of cleanliness and ‘Guidance for providers on meeting the
hygiene should be maintained in premises used regulations’ explains how to meet regulations
for the regulated activity. DH (2015) issued 12(2)(h) and 15 outlined above.
‘The Health and Social Care Act 2008 Code
of Practice on the prevention and control of 0.11 Failure to comply with the Health and
infections and related guidance’ (the HCAI Social Care Act 2008 (Regulated Activities)
Code of Practice), which contains statutory Regulations 2014 and the Care Quality
guidance about compliance with regulation Commission (Registration) Regulations
12(2)(h) (see paragraphs 0.15–0.17). (2009) is an offence, and the CQC has a
wide range of enforcement powers that it
0.9 Regulation 15 of the Act states that: can use if a provider is not compliant. These
include the issue of a warning notice that
(1) All premises and equipment used by the requires improvement within a specified
service provider must be – time, prosecution, and the power to cancel a
provider’s registration, removing its ability to
a. clean, provide regulated activities.
b. secure,
Examples of governance and assurance
c. suitable for the purpose for which they mechanisms arising from primary legislation
are being used, (not exhaustive)
NHS Constitution
d. properly used,
0.12 The Health Act 2009 places a duty
e. properly maintained, and on bodies providing and commissioning
NHS services to have regard to the NHS
f. appropriately located for the purpose Constitution. The Health and Social Care
for which they are being used. Act 2012 further applied this duty to the new
bodies created by that Act or by amendments
(2) The registered person must, in relation to to the 2012 Act.
such premises and equipment, maintain
standards of hygiene appropriate for the 0.13 The NHS Constitution “sets out rights to
purposes for which they are being used. which patients, public and staff are entitled”.
It also outlines “the pledges which the NHS
Note is committed to achieve, together with
responsibilities that the public, patients and
The “registered person” means, in respect staff owe to one another to ensure that the
of a regulated activity, the person who is the NHS operates fairly and effectively”.
service provider or a registered manager in
respect of that activity. 0.14 It commits the NHS to ensuring “that
services are provided in a clean and safe
A “service provider” means a person environment that is fit for purpose, based
registered with the CQC under Chapter 2 on national best practice (pledge)”. In order
of Part 1 of the Health and Social Care Act to deliver on this pledge, the NHS should take
2008 as a service provider in respect of that account of:
regulated activity.
• the NHS Premises Assurance Model
(NHS PAM) – the NHS PAM identifies
Regulator requirements
where the NHS Constitution needs to
0.10 The CQC independently regulates all be considered and where assurance is
providers of regulated health and adult social required;
care activities in England. The CQC’s (2015)
2
0 Policy and regulatory overview: water safety and the healthcare estate
3
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
and control the risks in water systems. The cold water services, new or extended, in any
HSE has published complementary technical healthcare premises should also comply with:
guidance in HSG274, which is split into three
specific areas: • the Water Supply (Water Fittings)
Regulations 1999;
• Part 1 – evaporative cooling systems; • Defra’s guidance to the Water Supply
• Part 2 – hot and cold water systems; and (Water Fittings) Regulations;
• Part 3 – other risk systems. • recommendations of the water suppliers
in the Water Regulations Advisory
0.21 In addition, under the Reporting of Scheme’s (WRAS) ‘Water Regulations
Injuries, Diseases and Dangerous Occurrences Guide’; and
Regulations (RIDDOR), there is a duty for
• any other requirements of the local water
employers to report any cases of legionellosis
undertaker.
in an employee who has worked on hot
and cold water systems that are likely to
be contaminated with Legionella. Cases of Water Supply (Water Fittings) Regulations
legionellosis are reportable under RIDDOR if: 1999
0.25 These Regulations set legal requirements
a. a doctor notifies the employer; and for the design, installation, operation and
maintenance of plumbing systems, water
b. the employee’s current job involves
fittings and water-using appliances. They
work on or near cooling systems that
have a specific purpose to prevent misuse,
are located in the workplace and
waste, undue consumption or erroneous
use water; or work on water-service
measurement of water and, most importantly,
systems located in the workplace
to prevent contamination of drinking water.
which are likely to be a source of
contamination. 0.26 These Regulations apply in all types of
premises supplied, or to be supplied, with
0.22 With regard to enforcement
water from a water undertaker. They apply from
responsibilities, the HSE will take the lead with
the point where water enters the property’s
regard to incidents involving Legionella. See
underground pipe, to where the water is used
the Health and Safety Executive/Care Quality
in plumbing systems, water fittings and water-
Commission/Local Government Association’s
using appliances. However they do not apply in
(2015) ‘Memorandum of understanding
premises that have no provision of water from
between the Care Quality Commission,
the public mains supply.
the Health and Safety Executive and local
authorities in England’.
Water Supply (Water Quality) Regulations
2000
Security 0.27 These Regulations cover the quality
0.23 Accessibility to all plant and equipment of water supplied by water undertakers
should be limited to authorised personnel only for public distribution which is intended for
(see NHS Protect’s (2012) ‘Guidance on the domestic purposes; these purposes include
security and management of NHS assets’). drinking, cooking, food preparation, washing
and sanitation. Water supplied meeting
these quality requirements is referred to as
Water regulations wholesome water.
0.24 As well as complying with the
recommendations outlined in this document,
the design and installation of the hot and
4
0 Policy and regulatory overview: water safety and the healthcare estate
5
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
PARLIAMENT
Legislation
LAW LAW LAW
Health and Social Health and Social CQC
Care Act 2012 Care Act 2008 Regulations
(Regulated Activities) 2014
CQC
Policy
drivers
facilities
for England
26 March 2013
July 2015
December 2013
Multimedia and
December 2013
August 2013
Figure 1 How best practice guidance on the safety and quality of healthcare estates and facilities fits in with the legislative and policy
framework. (The statutes and mandatory requirements shown in this figure are not exhaustive. See Note after paragraph 0.6.)
6
1 Introduction
1 Introduction
7
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
directors, or other person who is ultimately applicability will need to be considered in each
accountable, and on whom the duty falls, for case.
the safe operation of healthcare premises.
1.13 This HTM does not cover wet cooling
Shared premises systems such as cooling towers. Guidance
on these systems is given in HSE’s Approved
1.9 In estate management, it is increasingly Code of Practice and guidance ‘Legionnaires’
common for there to be several duty holders in disease: The control of Legionella bacteria in
one building. In such cases, duties may arise water systems (L8)’ and HSG274 technical
where persons or organisations have clear guidance Part 1.
responsibility through an explicit agreement
such as a contract or tenancy agreement. 1.14 While some guidance on other water-
service applications is included, it is not
1.10 The extent of the duty will depend on intended to cover them fully. For:
the nature of that agreement. For example, in
a building occupied by one leaseholder, the • process waters used for laundries, see
agreement may be for the owner or leaseholder HTM 01-04 – ‘Decontamination of linen
to take on the full duty for the whole building in health and social care’;
or to share the duty. In a multi-occupancy • endoscopy units, see HTM 01‑06
building, the agreement may be that the owner – ‘Decontamination of flexible
takes on the full duty for the whole building. endoscopes’;
Alternatively, it might be that the duty is
shared where, for example, the owner takes • primary care dental premises, see HTM
responsibility for the common parts while the 01-05 – ‘Decontamination in dental
leaseholders take responsibility for the parts practices’;
they occupy. In other cases, there may be an • renal units, see HBNs 07-01 and 07-02,
agreement to pass the responsibilities to a the Renal Association’s guidelines, BS
managing agent. Where a managing agent is EN ISO 13959 and BS EN ISO 11663;
used, the management contract should clearly
specify who has responsibility for maintenance • sterile services departments, see HBN 13
and safety checks, including managing the risk – ‘Sterile services department’;
from waterborne hazards. • hydrotherapy pools, see the PWTAG’s
‘Swimming pool water: treatment and
1.11 Where there is no contract or tenancy quality standards for pools and spas’;
agreement in place or it does not specify
• spa pools, see HSE/PHE’s ‘Management
who has responsibility, the duty is placed on
of spa pools: controlling the risks of
whoever has control of the premises or part of
infection’;
the premises.
Note
Areas this HTM does not cover This document is currently being revised
1.12 Although many of this HTM’s and will become HSG274 Part 4 – ‘The
recommendations will be applicable, it does control of Legionella and other infectious
not set out to cover water supply for fire- agents in spa pool systems’.
fighting services nor water supply for technical,
industrial or other specialist purposes, other • birthing pools, see HBN 09-02 –
than to indicate precautions that should be ‘Maternity care facilities’ and PWTAG’s
taken when these are used in association with ‘Swimming pool water: treatment and
domestic water services. The point at which quality standards for pools and spas’.
a domestic activity becomes an industrial
process has not been defined, and the
8
2 Governance and management responsibility
9
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
2.6 The WSP is a holistic approach to 2.10 The risk assessor(s) should be given
manage water for all uses (including diagnostic access to competent assistance from the
and treatment purposes) so that it is safe client. This may be in the form of:
for all users including those most at risk of
waterborne infections as a consequence of • engineering and building expertise;
their illness or treatment (see paragraphs • as-fitted drawings and schematic
6.16–6.22). diagrams;
2.7 All regular tests and checks set out in • clinical expertise;
the WSP should be carried out even if they • knowledge of building occupancy and
cause minor disruption to healthcare services, use including vulnerability of patient
and comprehensive records should be groups;
maintained in accordance with the healthcare
organisation’s management policy. • bespoke equipment plus policies,
procedures and any protocols (for
2.8 A risk assessment forms an integral example cleaning of wash-hand basins
component of the WSP and is a legal and disposal of clinical effluent etc).
requirement to identify potential hazards (which
may be microbial, chemical or physical) in 2.11 In addition access should be made
the system, risks of infection to patients, staff available to all required areas (and associated
and visitors, and other indicators of water systems and equipment) unless deemed
quality (for example, taste, odour, flavour and inaccessible by legislation (for example areas
appearance if intended for drinking). See that contain asbestos).
paragraphs 6.23–6.26 for typical examples of
2.12 For Legionella risk assessments,
issues to consider in the risk assessment.
contractors should be able to demonstrate a
2.9 The risk assessment should be carried full understanding of, and work to, BS 8580.
out by a competent person or persons. If the In addition to guidance provided above, the
provision of risk assessments is contracted to documents below should also be referenced
an external organisation, it is recommended in relation to the specification, procedures and
that those engaged to carry out any risk general requirements for completing robust and
assessments associated with water safety fit-for-purpose water safety risk assessments:
should be able to demonstrate to the WSG
• HSG274 Part 2 (2014) – ‘The control of
their experience and competence in assessing
Legionella bacteria in hot and cold water
specific risks from microbiological, chemical
systems’.
and physical hazards on the specific healthcare
population. They should also be able to give • BS 8580 – ‘Water quality: risk
advice on how to manage the systems/ assessments for Legionella control –
equipment to minimise the risks etc. It is the Code of Practice’.
responsibility of the WSG to determine the • BSRIA’s (1999) FMS 4/99 – ‘Guidance
method of demonstrating this competence. and the standard specification for water
Core requirements including accredited training services risk assessment’.
and personal examples of recent water safety
risk assessments in the healthcare sector • BSRIA’s (2015) BG 57/2015 –
presented orally and/or by interview should be ‘Legionnaires’ disease – risk
considered options. Detailed knowledge and assessment’.
expertise requirements of the risk assessor(s)
2.13 Management procedures should ensure
are provided in the World Health Organization’s
that compliance is continuing and not notional.
(WHO) (2011) ‘Water safety in buildings’.
The prime purpose of the assessment is to be
able to demonstrate that the WSG is aware of
10
2 Governance and management responsibility
Note
11
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
3 Statutory requirements
3.1 It is the responsibility of the duty holder The Management of Health and
to ensure that their premises comply with all
statutes.
Safety at Work Regulations 1999
3.5 These regulations provide a broad
3.2 Duty holders have an overriding general framework for controlling health and safety at
duty of care under the Health and Safety at work. They require every employer to make a
Work etc. Act 1974. Therefore, they should suitable and sufficient assessment of all risks
ensure that the water supply, storage and to health and safety of employees and the
distribution services are installed and operated public caused by work activities, and require
within the terms of the following legislation. employers to have access to competent help in
applying the provisions of health and safety law.
In addition to Legionella and other waterborne
Health and Safety at Work etc. Act pathogens, other risks from a hot and cold
1974 water distribution system include deterioration
3.3 Employers have a general duty under the of water quality, scalding at hot water outlets
Health and Safety at Work etc. Act 1974 to and danger due to pipe bursts at excessive
ensure, so far as is reasonably practicable, the pressures.
health, safety and welfare of patients, visitors
and staff and the public who may be affected Control of Substances Hazardous
by workplace activities.
to Health (COSHH) Regulations
3.4 These duties are legally enforceable, 2002
and the HSE has successfully prosecuted
employers including health organisations 3.6 These regulations provide a framework
under this statute. It falls upon owners and of actions designed to control the risk from
occupiers of premises to ensure that there a range of harmful substances including
is a management regime for the proper waterborne pathogens such as Legionella and
design, installation and maintenance of plant, the chemicals that may be used to control the
equipment and systems. Failure to have a growth of microorganisms in water supplies.
proper system of working and adequate control Employers have a duty to assess the risks from
measures can also be an offence even if an exposure to these substances to ensure that
outbreak of, for example, Legionnaires’ disease they are adequately controlled.
or other such incident has not occurred.
12
3 Statutory requirements
Public Health (Infectious Diseases) purposes. These regulations also place duties
for monitoring and control of the quality of
Regulations 1988 public water supplies where these are then
3.7 The Public Health (Infectious Diseases) further distributed to separate premises by the
Regulations 1988 require that a properly bill payer other than the water undertaker or
appointed officer inform the chief medical licensed water supplier (often referred to as
officer for England or for Wales, as the case onward distribution).
may be, of any serious outbreak of any disease
that to his/her knowledge has occurred in the
district. Food Safety Act 1990
3.10 The Food Safety Act 1990 covers water
Note used for food preparation or food manufacture
and also includes water used for drinking. The
Appendix 2.3 of HSE’s Legionella Food Safety and Hygiene (England) Regulations
technical guidance HSG274 Part 2 (2013) 2013 are also relevant.
contains further advice and guidance on
communication and cooperation with
the consultant in communicable disease The Health and Safety Executive’s
control (CCDC), and on arrangements for (4th edition) Approved Code of
support of the CCDC and for this person
to have access to provider units including Practice L8 2013
healthcare organisations. 3.11 The HSE’s (2013) Approved Code of
Practice L8 (4th edition) came into effect
on 7 November 2013 and is supported
Water Supply (Water Quality) by the technical guidance (HSG274 Parts
Regulations 2000 1–3). It replaced the earlier publication
entitled ‘Legionnaires’ disease: The control
3.8 The Water Supply (Water Quality) of Legionella bacteria in water systems –
Regulations 2000 apply to water supplied by Approved Code of Practice and guidance’ (L8
a water undertaker to any premises that are 3rd edition). The onus is on the duty holder to
used for domestic purposes such as drinking, demonstrate that procedures in place are as
cooking, personal hygiene, washing or food good as, or better than, those required by L8.
production.
3.12 The Approved Code of Practice L8 has a
Note special legal status. If a person or organisation
is prosecuted for a breach of health and safety
Two additional sources of advice on drinking law and it is proved that they did not follow the
water quality are: provisions of the Code, they will need to show
that they have complied with the law in some
a. the director of public health; other equally effective way or a court will find
b. WHO’s ‘Guidelines for drinking water them at fault. Health and safety inspectors seek
quality’. to secure compliance with the law and may
refer to this guidance.
14
4 Legionella: overview
4 Legionella: overview
16
4 Legionella: overview
17
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
18
5 Pseudomonas aeruginosa and other waterborne pathogens: overview
19
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
20
5 Pseudomonas aeruginosa and other waterborne pathogens: overview
21
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
6 Operational management
22
6 Operational management
infection from Legionella, P. aeruginosa and departments offering aquatic therapy), and
and other waterborne pathogens (that is, sterile services departments (SSDs). See Figure
the materials and components, the types 2 for an example structure and see also the
of use and modes of exposure, together Note under paragraph 6.3.
with the susceptibility to infection of
those likely to be exposed); 6.7 As and when required, the local security
management specialist (LSMS) should provide
• have knowledge of the particular a security management input. The LSMS
vulnerabilities of the at-risk population should be consulted in any vulnerability and
within the facility; as part of its wider risk assessments being undertaken, to ensure
remit, the WSG should include that the security of the water systems is
representatives from areas where fully considered and proportionate security
water may be used in therapies, measures are implemented.
medical treatments or decontamination
processes where exposure to aerosols 6.8 The WSG should be led and chaired by
may take place. a person who has appropriate management
responsibility, knowledge, competence and
6.6 This would normally involve representation experience. Where required, it may appoint in
from estates (operations and projects), writing an independent professional adviser/
infection control, medical microbiology, Authorising Engineer (Water) with a brief to
nursing, augmented care, housekeeping/ provide services in accordance with this HTM
support services, an Authorising Engineer/ and the HSE’s technical guidance HSG274
independent adviser, medical technical officers, Part 2.
specialist users of water (such as renal units
Management
(e.g. Board, CEO, Duty
holder)
Facilities Estates
Management Management
Water
Contractors
23
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
24
6 Operational management
(see Figure 3). It will identify potential water- water safety. See paragraph 6.21 for a list of
related hazards, consider practical aspects elements that the WSP should incorporate.
and detail appropriate control measures. The
content of a WSP will depend on the size and 6.17 Those organisations with existing robust
complexity of the healthcare organisation’s water management policies for waterborne
water system. The plan will include governance hazards will already have in place much of the
arrangements related to the management of integral requirements for developing a WSP.
Periodic review
Assess and prioritise risks
Controlling risks
Figure 3 Documentation of management procedures (adapted from Figure 4.1 in WHO’s ‘Water safety in
buildings’)
25
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
26
6 Operational management
• amendments when changes are carried • clinical practice where water may come
out including new builds, refurbishments into contact with patients and their
and recently decommissioned clinical invasive devices;
departments or units; • the appropriate cleaning of the
• amendments made when changes are environment and equipment;
made at the annual review. • the disposal of blood, body fluids and
patients’ wash-water;
6.22 The WSP should identify potential alert
organisms and microbiological hazards caused • the maintenance and cleaning of wash-
by Legionella, P. aeruginosa and other relevant hand basins and associated taps,
pathogens, consider practical aspects and specialist baths and other water outlets;
detail appropriate control measures. • suitable siting and installation of wash-
hand basins including the appropriate
Risk assessments positioning of soap and antimicrobial
hand-rub dispensers;
6.23 The risk assessments that inform the
WSP should identify potential hazards caused • change in use (for example, clinical
by Legionella, P. aeruginosa and other relevant area changed to office accommodation
pathogens, chemicals, temperature and events or vice-versa) due to refurbishment or
that may arise during supply, storage, delivery, operational necessity;
maintenance and use of water in healthcare • other devices that increase/decrease
facilities. the temperature of water (for example,
ice-making machines, water chillers)
6.24 Once potential hazards and hazardous which may not be appropriate where
events have been identified, the severity of patients are at particular risk such as in
risk needs to be assessed so that priorities for augmented care settings;
risk management can be established. The risk
assessment needs to consider the likelihood • engineering assessment of water
and severity of hazards and hazardous events systems, including appropriate design,
in the context of exposure (type, extent and installation, commissioning, maintenance
frequency) and the vulnerability of those and verification of the effectiveness of
exposed. Although many hazards may threaten control measures (see also the Water
water quality, not all will represent a high risk. Supply (Water Fittings) Regulations
The aim should be to distinguish between high 1999);
and low risks so that attention can be focused • infrequently used outlets;
on mitigating risks that are more likely to cause • previous risk assessment, current control
harm (see BS 8580 for guidance on Legionella measures and documentation;
risk assessments). Typical examples of issues
to consider may include the following: • policies and procedures;
• the unnecessary use of flexible hoses
• governance and accountability; and any containing inappropriate lining
• the susceptibility of all who may be materials;
exposed to water (including ice) used for • sampling, monitoring and testing
diagnosis and treatment; programmes that needs to be put in
• scalding risk and the appropriate place;
installation of TMVs; • backflow protection;
• failure to maintain necessary hot and cold • safe access to equipment;
system supply temperatures;
27
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
28
6 Operational management
29
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
timescales to minimise these risks. The action 6.37 Before lowering or assisting patients
plan should include: into the bath, the water temperature must be
checked with a thermometer to ensure that it
• appropriate remedial actions, monitoring has fallen to a safe value.
details and schedules for validation that
show the remedial actions are effective
and subject to ongoing verification Utilisation
(completion dates should be defined); 6.38 One of the critical factors affecting the
• any training and competency issues quality of water within hot and cold water
required to ensure compliance with this distribution systems is the extent of utilisation.
guidance.
6.39 Where stagnation occurs or utilisation
Advice on exposure of augmented care is low, cold water temperature can increase
patients to P. aeruginosa is covered in HTM significantly and approach the range that
04-01 Part C. is conducive to the growth of a variety of
waterborne pathogens such as Legionella.
Where hot and cold water is mixed, further
Documentation opportunities arise for deterioration in water
6.33 All records pertaining to the risk quality.
assessment and action plan should be held
6.40 TMVs should not be installed in series
and managed by the WSG.
with mixing taps (thermostatic or manual) (see
also paragraphs 6.52–6.58 on maintenance
Safe hot water temperature practice).
6.34 See paragraphs 10.57–10.59 in 6.41 The WSG needs to ensure that there
HTM 04-01 Part A for guidance on safe water is good liaison between the estates officers/
temperatures and delivery devices. See also maintenance providers and clinicians to ensure
HSE’s ‘Managing the risks from hot water and that the water services are sufficiently used.
surfaces’.
6.42 HSG274 Part 2 recommends that
6.35 To reduce the risk of scalding, generally, for infrequently used outlets,
thermostatic mixing devices are required for flushing is carried out once a week but that
specific hot water outlets (see Table 2 in in healthcare facilities the risk assessment, as
HTM 04-01 Part A). A scalding risk assessment agreed by the WSG, may indicate a higher
is necessary to establish the need and type of frequency, and water draw-off should form part
device to be installed. of the daily cleaning process. The procedure for
such practice should be fully documented and
6.36 As with any safety device, routine covered by written instructions.
checks will be essential to ensure continued
satisfactory operation (see Chapter 11 of 6.43 Monitoring of water usage on a building-
HTM 04-01: Supplement – ‘Performance by-building basis can indicate when usage
specification D 08: thermostatic mixing valves falls and the risk increases. Reductions in
(healthcare premises)’). Such devices, however, normal usage patterns should be investigated
should not be a substitute for caution. For and remedial measures introduced following
example, when performing assisted bathing, investigations by the WSG.
it is often necessary to set the delivery
temperature to a higher level than that normally
considered safe to allow for the cooling effect
of large baths that are required.
30
6 Operational management
generally given the highest priority and is the b. How long can a breakdown of
minimum requirement that must be satisfied. particular plant be tolerated?
Chapter 3 lists specific statutes that must be
complied with. Additional advice is provided in c. What cost can be justified to avoid
BS EN 806-5 and BS 8558. breakdown of particular plant such as
standby pumps, dosing pumps etc?
Note d. The availability of suitable spares.
BS EN 806-5 and complementary guidance
6.57 If response to failure is critical for certain
in BS 8558 covers the operation and
items of plant, the maintenance organisation
maintenance of water systems, in which a
will require a planned strategy of calling out
number of aspects are covered:
skilled staff to achieve an agreed response
• operation; time and to minimise the interval between
breakdown and the diagnosis and repair of
• interruptions to operation and
the plant.
disconnection;
• resumption of supply; 6.58 The approach for healthcare premises
should be based on that of planned preventive
• damage and faults (change in water
maintenance (PPM) as any failure in the water
quality, insufficient water supply, noise
services would be seriously detrimental to the
emission);
provision of healthcare. The PPM programme
• alterations, extensions and and any subsequent amendments should
refurbishment; be agreed by the WSG (see also Chapter 5
• accessibility of installation on maintenance in HTM 00 – ‘Policies and
components; principles of healthcare engineering’).
• maintenance.
Maintenance responsibility
6.54 Regulations require notification to the 6.59 A maintenance manager should be given
water undertaker of any proposed changes responsibility for implementation of a risk-
and additions to the water supply system in the based operational maintenance strategy. These
premises. Before making any changes, a risk responsibilities will include:
assessment should be carried out and audited
by an independent assessor. Further details a. the provision of adequately trained
can be found on the WRAS website. and supervised labour (see also
paragraph 6.30 on water hygiene
6.55 Maintenance is required to achieve training);
optimum economic life and maintain maximum
operational efficiency of the plant. b. clear definitions of the equipment and
services to be maintained, together
6.56 There should be a risk assessment to with the procedures to be carried out
decide the appropriate type of maintenance (for on them;
example scheduled, corrective or condition-
based) for the different items of plant. The c. monitoring of the quality of the
following should be considered: work carried out to ensure that it is
consistently acceptable;
Would a breakdown of a particular
a.
service during working, or outside d. the identification of appropriate
normal, hours pose a risk to patient resources and the implementation of
safety and wellbeing? financial control procedures.
32
6 Operational management
33
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
34
6 Operational management
35
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
6.79 Records should be kept for at least five 6.82 In addition to drawings, there should
years unless they are required to be kept longer be comprehensive schedules of outlets, lists
by the organisation’s data management policy. of sentinel taps (outlets), other outlets to be
tested (frequency as per the WSP) and other
components in the system.
36
6 Operational management
Asset register
6.83 The WSG should ensure that an accurate
record of all assets relating to the hot and
cold water distribution systems is set up and
regularly maintained. They should also ensure
that records of all maintenance, inspection
and testing activities are kept up-to-date and
properly stored.
37
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
38
7 Description of systems, operational considerations and requirements
7.7 The WSG should be actively involved 7.14 Meters should ideally provide a pulse
in the decision-making process and should output that can be monitored by a BMS, but if
involve consultation with the water undertaker not should be read on a regular basis (monthly)
to ensure the suitability of biocidal products for and consumption monitored. Data from
their intended application. the meter should be reviewed over time for
anomalies (typically low or high consumption
For further information on biocidal rates). Graphical methods may be beneficial.
treatment, see Chapter 4 of HTM 04-01 Where it is desirable to connect to the water
Part A. For ongoing checks, see HSG274 undertaker’s meter, its authorisation must be
Part 2. gained in advance.
Water storage
Water softening 7.16 For general information on water storage,
7.9 See Chapter 6 in HTM 04-01 Part A. see Chapter 8 in HTM 04-01 Part A.
39
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
40
7 Description of systems, operational considerations and requirements
41
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
42
7 Description of systems, operational considerations and requirements
43
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
7.44 It is important to note the distinction may require additional backflow protection or
between self-purging and self-draining showers. modification of the system. In addition, sufficient
Self-purging showers can be an effective activity space should be maintained to enable
Legionella control procedure, while self-draining the outlet to be used without contaminating the
showers can support the proliferation of filter.
Legionella.
7.48 Where filters are in place, follow
manufacturers’ instructions for cleaning, or they
Note should be wiped clean as part of the basin/sink
cleaning protocol as agreed by the WSG.
Adjustable showerheads are not
recommended in healthcare facilities. See 7.49 Where point-of-use filters are no longer
paragraph 10.61 in HTM 04-01 Part A. required, the outlet connection should be
flushed, cleaned and disinfected to remove any
accumulated biofilm.
Point-of-use filtration
7.45 Point-of-use (POU) filtration should be Removal of redundant pipework
considered and agreed by the WSG only as an and services
interim safeguard where control measures have
been ineffective, prior to and during engineering 7.50 In existing systems or during
remedial works, during periods of plumbing refurbishments, water systems should be
refurbishments and maintenance works, and inspected to identify redundant pipework (often
where additional protection is required for referred to as blind ends) or services. In such
vulnerable patients. Continuous long-term use cases, pipework should be cut back to the
of POU filters is not recommended, except connection point including replacing the
where there is no effective alternative. The WSG branch T with a straight coupling to ensure all
should review their continued use and ensure redundant pipework is removed and to
an action plan is created and enacted to make eliminate any opportunity for stagnation to
certain they are changed at the intervals occur.
specified by the manufacturer.
44
7 Description of systems, operational considerations and requirements
45
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Table 1 Checklist for hot and cold water systems (adapted from HSG274 Part 2)
Frequency (see
Service Action to take paragraph 7.53)
Calorifiers Inspect calorifier internally by removing the inspection hatch Annually, or as indicated
or using a borescope, and clean by draining the vessel. The by the rate of fouling
frequency of inspection and cleaning should be subject to the
findings and be increased or decreased based on conditions
recorded
Where there is no inspection hatch, purge any debris in the Annually, but may be more
base of the calorifier to a suitable drain frequent as indicated
Collect the initial flush from the base of hot water heaters to by the risk assessment
inspect clarity, quantity of debris and temperature or result of inspection
findings
Check calorifier flow temperatures (thermostat settings should Monthly
modulate as close to 60°C as practicable without going below
60°C)
Check calorifier return temperatures (not below 50°C).
Hot water For non-circulating systems: take temperatures at sentinel Monthly
services points (nearest outlet, furthest outlet and long branches to
outlets) to confirm they are at a minimum of 55°C within one
minute
For circulating systems: take temperatures at return legs Monthly
of principal loops (sentinel points) to confirm they are at a
minimum of 55°C. Temperature measurements may be taken
on the surface of metallic pipework
For circulating systems: take temperatures at return legs of Quarterly (ideally on a
subordinate loops; temperature measurements can be taken rolling monthly rota)
on the surface of pipes, but where this is not practicable, the
temperature of water from the last outlet on each loop may be
measured, and this should be greater than 55°C within one
minute of running. If the temperature rise is slow, it should be
confirmed that the outlet is on a long leg and not that the flow
and return has failed in that local area
All HWS systems: take temperatures at a representative Representative selection
selection of other points (intermediate outlets of single pipe of other sentinel outlets
systems and tertiary loops in circulating systems) to confirm considered on a rotational
they are at a minimum of 55°C to create a temperature profile basis to ensure the
of the whole system over a defined time period whole system is reaching
satisfactory temperatures
for Legionella control
POU water Check water temperatures to confirm the heater operates at Monthly–six monthly, or
heaters (no 55°C, or check the installation has a high turnover as indicated by the risk
greater than assessment
15 litres)
Combination Inspect the integral cold water header tanks as part of the cold Annually
water heaters water storage tank inspection regime; clean and disinfect as
necessary. If evidence shows that the unit regularly overflows
hot water into the integral cold water header tank, instigate a
temperature-monitoring regime to determine the frequency, and
take precautionary measures as determined by the findings of
this monitoring regime
Check water temperatures at an outlet to confirm the heater Monthly
operates at 55°C
46
7 Description of systems, operational considerations and requirements
Frequency (see
Service Action to take paragraph 7.53)
Cold water Inspect cold water storage cisterns and carry out remedial Annually
storage cisterns work where necessary
Check the cistern’s water temperature remote from the Annually (summer) or
ball valve and the incoming mains temperature. Record as indicated by the
the maximum temperatures of the stored and supply water temperature profiling
recorded by fixed maximum/minimum thermometers where
fitted
Cold water Check temperatures at sentinel taps (typically those nearest to Monthly
services and furthest from the cold cistern, but may also include other
key locations on long branches to zones or floor levels). These
outlets should be below 20°C within two minutes of running
the cold tap. To identify any local heat gain, which might not be
apparent after one minute, observe the thermometer reading
during flushing
Take temperatures at a representative selection of other Representative selection
points to confirm they are below 20°C to create a temperature of other sentinel outlets
profile of the whole system over a defined time period. Peak considered on a rotational
temperatures or any temperatures that are slow to fall should basis to ensure the
be an indicator of a localised problem whole system is reaching
satisfactory temperatures
for Legionella control
Check thermal insulation to ensure it is intact, and consider Annually
weatherproofing where components are exposed to the
outdoor environment
Showers and Dismantle, clean, descale and disinfect removable parts, Quarterly or as indicated
spray taps heads, inserts and hoses where fitted by the rate of fouling or
other risk factors, e.g.
areas with high-risk
patients
POU filters Record the service start date and lifespan or end date and According to
replace filters as recommended by the manufacturer (bacterial- manufacturer’s guidelines
retention filters should be used primarily as a temporary control
measure while a permanent solution is developed, although
long-term use of such filters may be needed in some healthcare
applications)
Base exchange Visually check the salt levels and top up salt, if required. Weekly, but depends on
softeners Undertake a hardness check to confirm operation of the the size of the vessel
softener and the rate of salt
consumption
Service and disinfect Annually, or according to
manufacturer’s guidelines
Multiple-use Backwash and regenerate as specified by the manufacturer According to
filters manufacturer’s guidelines
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Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Frequency (see
Service Action to take paragraph 7.53)
Infrequently Consideration should be given to removing infrequently used Weekly, or as indicated by
used outlets showers, taps and any associated equipment that uses water. the risk assessment
If removed, any redundant supply pipework should be cut back
as far as possible to a common supply (e.g. to the recirculating
pipework or the pipework supplying a more frequently used
upstream fitting) but preferably by removing the feeding ‘T’
Infrequently used equipment within a water system (i.e. not
used for a period equal to or greater than seven days) should
be included on the flushing regime
Flush the outlets until the temperature at the outlet stabilises
and is comparable to supply water and purge to drain
Regularly use the outlets to minimise the risk from microbial
growth in the peripheral parts of the water system, sustain and
log this procedure once started
TMVs Where integral, inspect, clean, descale and disinfect any Annually or on a
strainers or filters associated with TMVs. frequency defined by
To maintain protection against scald risk, TMVs require regular the risk assessment,
routine maintenance carried out by competent persons in taking account of
accordance with the manufacturer’s instructions. There is any manufacturer’s
further information in paragraphs 2.152–2.168 of HSG274 recommendations
Part 2.
Inline strainers Where fitted, inspect, clean, descale and disinfect any strainers Annually or on a
or filters associated with TMVs or other sensitive equipment. frequency defined by
the risk assessment,
taking account of
any manufacturer’s
recommendations
Pressurisation Where practical, flush through and purge to drain. Monthly–six monthly,
and expansion Where removable, bladders or diaphragms should be changed as indicated by the risk
vessels according to the manufacturer’s guidelines or as indicated by assessment
the risk assessment
Biocidal Check the dosing and control system operation including Weekly
treatment alarms
systems Measure the treatment parameters to establish the required Weekly
values are being achieved at representative outlets including
sentinel outlets
Note: Validation and calibration
Consider 24-hour automatic monitoring for biocidal treatment of the automatic
on large or complex systems monitoring system should
be carried out at the
frequencies recommended
by the manufacturer
48
8 Other operational considerations
49
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Notice NHSE SN(96)06 – ‘Evaporative type Lawn sprinklers and garden (or
cooling fan’.
similar) hoses
8.13 In certain conditions, lawn sprinklers
Non-wholesome water storage may retain stagnant water in the pipework/
8.10 Non-wholesome water is sometimes hose supplying the sprinkler head; they may
stored for emergency use (for example for fire- also produce an aerosol spray. The pipework
fighting purposes). These systems should have may be installed underground or via a flexible
an appropriate backflow prevention device hose over ground. In either case it is very
in accordance with the Water Supply (Water unlikely that they can be completely drained
Fittings) Regulations 1999. They should be down after use or when not required; at certain
considered by the risk assessment and the times in the year the retained water may be
WSG. at temperatures suitable for the colonisation
by, and multiplication of, Legionella and
P. aeruginosa. There is evidence linking cases
Deluge showers of Legionnaires’ disease with permanently
8.11 Deluge showers (sometimes called installed systems that use underground
emergency showers) are intended for use supply plumbing. Irrigation systems and
in an emergency where a staff member or hoses for these purposes should be supplied
a patient has suffered external chemical via backflow prevention devices giving fluid
contamination. Similarly, there may be other category 5 protection – typically an air gap
special outlets used for personal emergencies, of Type AA or AB, which requires a break
for example eyebaths. These should not be tank and booster pump to provide adequate
installed on the end of lines. They should be pressure to the irrigation nozzle or hose outlet.
dismantled, descaled and disinfected regularly A risk assessment should be undertaken prior
in accordance with the risk assessment, and to use to minimise the risk by implementing
should be flushed in accordance with the suitable control measures.
recommendations in HSG274 Part 3. 8.14 Hoses used for filling of remote
equipment or mobile units should be of
Trolley wash procedures materials suitable for use with wholesome
water systems and should be drained, capped
8.12 High-pressure hoses will generate between uses and kept in cool conditions.
aerosols and have been associated with They should be disinfected (by immersing in
causing cases and outbreaks of Legionnaires’ hypochlorite) before use.
disease. The contamination of the aerosol can
be reduced if the water supply is taken from a
wholesome water system via a suitable air gap Vehicle-washing plant
giving fluid category 5 protection – typically 8.15 Vehicle washing is carried out either
an air gap of Type AA or AB, which requires using a hand-held pressure spray or by a
a break tank and booster pump to provide frame wash that consists of a bay containing a
adequate pressure to the washing equipment. rectangular pipework frame fitted with several
Procedures should be put in place to flush to high-pressure sprays. In the latter case,
drain before use, and to disinfect them if they this equipment should be flushed regularly.
have been out of use for a prolonged period. Pressure washers and frame washers should
be supplied via backflow prevention devices
giving fluid category 5 protection – typically
an air gap of Type AA or AB, which requires
a break tank and booster pump to provide
adequate pressure to the outlets. See the
50
8 Other operational considerations
Water Management Society’s ‘Managing the Wet fire and automatic sprinkler
risk of legionnaires’ disease in vehicle-washing
systems W046-5’.
systems
8.20 Wet fire protection systems have been
8.16 Permanent hard-standing areas for implicated in outbreaks of legionellosis. All hose
vehicle-washing purposes should have an even reels, sprinkler systems and wet risers should
surface to avoid ponding and have a slope or be isolated from the potable water supply by a
dish to a suitable drain. method permitted by the Water Supply (Water
Fittings) Regulations 1999. Many fire authorities
are not in favour of local fire-fighting, preferring
Decorative internal and external early professional intervention. It may, therefore,
water features be possible to remove hose reels, thus avoiding
8.17 Internal ornamental water features (for their hazards. (Any redundant pipework should
example a water cascade in the main entrance be cut back to the connection point including
hall) are susceptible to airborne contamination replacing the branch ‘T’ with a straight
and are not recommended. coupling.)
51
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Buried pipelines
8.25 Pipelines made of plastics are susceptible
to hydrocarbons such as fuels and oils. These
chemicals can permeate through plastic
pipes if they are nearby and contaminate the
water supply, and it may take days, weeks or
even months before a noticeable taste can
be detected in the water supply. Whenever
spills are reported, an assessment of services
within the area should be undertaken. See also
paragraphs 12.8–12.16 in HTM 04-01 Part A.
52
9 Microbiological monitoring
9 Microbiological monitoring
53
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
10.1 Legionella monitoring should be carried b. In systems where the temperature
out where there is doubt about the efficacy of or biocidal control regimes are not
the control regime or where the recommended consistently achieved, weekly checks
temperatures, disinfectant concentrations or are recommended until the system
other precautions are not consistently achieved is brought under control, after which
throughout the system. The WSG should use the frequency of monitoring can be
risk assessments to determine when and reviewed.
where to test, which may include the following
circumstances: c. When a nosocomial outbreak is
suspected or has been identified.
a. When storage and distribution
temperatures do not achieve those d. Where there are at-risk patients with
recommended and systems are increased susceptibility.
treated with a biocide regime, testing
should be carried out monthly,
although that frequency may be
altered depending on the results
obtained.
54
10 Testing for Legionella
10.2 As a minimum, samples should be taken 10.3 Analysis of water samples for Legionella
as follows: should be performed in UKAS-accredited
laboratories with the current ISO standard
• from the cold water storage and the methods for the detection and enumeration
furthermost outlet from the tank; of Legionella included within the scope of
• from the calorifier flow, or the closest accreditation. These laboratories should
tap to the calorifier, and the furthermost take part in a water microbiology proficiency
tap on the hot water service circulating testing scheme (such as that run by PHE or
system; an equivalent scheme accredited to BS EN
ISO 17043). Alternative quantitative testing
• additional samples should be taken from methods may be used as long as they have
the base of the calorifier where drain been validated using BS EN ISO 17994 and
valves have been fitted; meet the required sensitivity and specificity.
• additional random pre- and post- The laboratory should also apply a minimum
flush samples may also be considered theoretical mathematical detection limit of ≤100
appropriate where systems are known to Legionella bacteria/litre sample.
be susceptible to colonisation in line with
BS 7592 guidance; 10.4 Action following Legionella sampling in
hot and cold water systems is given in the
• methods should be in accordance with following flowcharts (see Figures 4–6).
BS 7592.
Note
55
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
56
10 Testing for Legionella
Figure 4 Action levels following Legionella sampling in hot and cold water systems. Example 1
57
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Legionella result
Any Count <100 cfu/t >100 sample <1000 cfu/L or repeat positive of <100 cfu/L >1000 cfu/L
Place back Take R.A. No. 4 Place back Take R.A. No. 5
into sampling NOTE* into sampling NOTE*
NOTE routine NOTE^^^ routine NOTE^^^
Figure 5 Action levels following Legionella sampling in hot and cold water systems. Example 2
58
10 Testing for Legionella
No
No
Post-flush samples or multiple positive
Outlets from mixed hot and cold samples from the same water system
water incorporating showers or may be an indication that the whole
hoses or TMVs are not good Blended / TMV / water systems is contaminated and that
locations for systemic testing. Shower/ Hoses controls are not effective.
Yes No
Systemic colonisation
Outlet colonisation
suspected
suspected
Protecting highly susceptible patients requires the
Protecting highly susceptible patients requires the detection
detection of any legionella even very low levels to be
of any legionella even very low levels to be investigated.
investigated. and, if necessary, the system resampled to aid
and, if necessary, the system resampled to aid interpretation 100cfu/ltr or less interpretation of the results in line with the monitoring
of the results in line with the monitoring strategy and risk
assessment. Yes Yes strategy and risk assessment.
Identify remedial actions, Investigate: - Whilst low numbers are unlikely to pose a risk to the general
o Usage frequency
No population, (high risk patients may be at risk).
o Outlet for corrosion and scale Review immediately the system control measures (thermal
o local heat gain, and chemical) and risk assessment
o Local Dead ends Identify remedial actions, Investigate: -
o Cross flow between hot and cold and vice versa, Hot water backflow via the calorifier cold feed pipes,
o Localised failure of the HWS return Calorifier discharge via open vents to the cold tank, Failure
It may be appropriate to immediately resample to indicate if of HWS to operate at target temperatures, Over capacity or
initial remedial actions have been effective. The locations under usage.
should then be resampled after 3 to 6 months to confirm Cleaning & Disinfection of the entire system should be
any actions taken have remained effective. considered
Review the need for any TMVs taking into account the >100cfu/ltr It may be appropriate to confirm effective disinfection, any
relative risks of scalding. Remove the TMV if considered <1000cfu/ltr required microbiological samples should be taken between
appropriate. two and seven days after the system is treated. (Samples
Where TMVs remain, clean and disinfect the TMVs, the Yes Yes taken immediately after a disinfection process might give
outlet and the strainers on both cold and hot feeds. false negative results).
Consider removal / replacement of any flexible hoses No The water system should then be resampled regularly to
(particularly after the TMVs) avoiding the use of flexible confirm any actions taken have remained effective.
hoses where practicable.
In addition to the above
Review immediately the local control measures and risk
assessment to identify any required remedial action (dead
ends etc) Action required
Cleaning and Disinfection of the outlet should be In addition to the above
undertaken - (especially showers and spray taps) Cleaning & Disinfection of the entire system is likely to be
If a shower (or spray outlet) cannot be taken out of use, required.
>1000cfu/ltr
consider installing point of use microbiological filters on all To confirm effective disinfection microbiological samples
affected showers. should be taken between two and seven days after the
Yes Yes
It is likely to be appropriate to resample, between two and system is treated. (Samples taken immediately after a
seven days after remedial action, to indicate if the actions No disinfection process might give false negative results).
have been effective.
The locations should then be resampled (e.g. 1 to 3 months
later) to confirm any actions taken have remained effective.
In addition to the above.
Take immediate measures to prevent exposure from this
outlet until remedial measures are taken and shown to be
Action required
effective.
In addition to the above.
If the outlet cannot be taken out of use, install a point of use
Take immediate measures to prevent exposure from all
microbiological filter on all affected outlets.
outlets fed by the system until remedial measures are taken.
Resample, between two and seven days after, to indicate if
Clean & Disinfect the entire system as soon as possible.
initial remedial actions have been effective.
The locations should then be regularly resampled to confirm
any actions taken have remained effective.
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Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
A1. All water and water systems in healthcare A2. Examples of different categories of water
facilities should be risk-assessed according to for differing uses are shown in Table A1.
their intended use and patient immune status
taking into account any identified inherent Note
hazards within the facility and the quality of the
water supply to the systems being assessed. The hazards and their occurrence will
The assessment of risk should take account depend on the quality of source water.
of the most vulnerable population likely to be Therefore the associated risks should
exposed to each potential source. be calculated taking into account local
conditions.
60
Appendix A Examples of the use of water within a healthcare facility and water quality types
61
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Particular
hazards
(based on an
Physical, chemical or microbial Water quality parameters assessment for
Healthcare area Application quality indicators given in: each system) See also
Renal units and Water for Total viable counts and • BS ISO 13959: Water • HBN 07-01 Satellite
satellite dialysis haemodialysis endotoxin concentrations for haemodialysis and dialysis units
units related therapies. • HBN 07-02 Main renal
• BS ISO 11663: Quality units
of dialysis fluid for
haemodialysis and
related therapies.
• BS ISO 13958:
Concentrates for
haemodialysis and
related therapies.
Augmented Pseudomonas aeruginosa: HTM 04-01 Part B and
care Colony counts per 100 mL Part C: Pseudomonas
units aeruginosa – advice for
augmented care units
Aquatic therapy pH, free residual halogen, total • See the PWTAG’s
pools and combined halogen and ‘Swimming pool water:
other treatment parameters. treatment and quality
Coliforms, E.coli, Pseudomonas standards for pools and
aeruginosa and TVCs spas’;
Spa pools and pH, free residual halogen and • See HSE/PHE’s
whirlpools other treatment parameters ‘Management of spa
pools: controlling the risks
of infection’;
Note
This document is currently
being revised and will
become HSG274 Part 4 –
‘The control of Legionella
and other infectious agents
in spa pool systems’.
62
Appendix A Examples of the use of water within a healthcare facility and water quality types
Particular
hazards
(based on an
Physical, chemical or microbial Water quality parameters assessment for
Healthcare area Application quality indicators given in: each system) See also
Sterile services Final rinse Appearance: HTM 01-01 Part D Washer
departments • pH disinfectors
• Conductivity at 25ºC
• Total dissolved solids
• Total hardness
• Chloride, Cl
• Heavy metals, determined
as Lead, Pb
• Iron, Fe
• Phosphate, P2 O5
• Silicate, SiO2
• Total viable count at 22ºC
• Total viable count at 37ºC
• Bacterial endotoxins
Other stages • Total hardness
• Chloride, Cl
• Silicate, SiO2
Laundries Final rinse Hardness (total Ca2+/Mg2+) HTM 01-04 Decontamination Clostridium Textile Services Association’s
• pH of linen for health and social difficile (2008) “Target specification for
• Turbidity care: engineering, equipment Bacillus cereus recycled water to meet final
and validation rinse quality”.
• Colour
• Iron
• Manganese
• Copper
• Surfactant
• Bioburden (TVC)
Dental facilities Dental unit water Legionella spp.: colony Chapter 19 in HTM 01-05 Legionella spp.
lines and water counts per litre Pseudomonas Decontamination in primary Pseudomonas
systems aeruginosa colony counts per care dental facilities aeruginosa and
100 mL https://www.gov.uk/ other waterborne
government/uploads/system/ pathogens
uploads/attachment_data/
file/170689/HTM_01-
05_2013.pdf
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Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
B1. In England and Wales, Legionnaires’ B4. The HSE or local environmental health
disease is notifiable under the Health Protection officers (EHOs) may be involved in the
(Notification) Regulations 2010. Under these investigation of outbreaks, their aim being
regulations, registered medical practitioners to pursue compliance with health and safety
must report cases of Legionnaires’ disease legislation. The local authority, Proper Officer or
to the Proper Officer. These regulations also EHO acting on their behalf will make a site visit
require human diagnostic laboratories to to carry out a public health risk assessment,
notify PHE of cases of Legionnaires’ disease often with the relevant officer from the enforcing
identified by laboratory testing. authorities (the HSE or the local authority) for
health and safety reasons. Any infringements of
B2. An outbreak is defined as two or more relevant legislation may be subject to a formal
cases where the onset of illness is closely investigation by the appropriate enforcing
linked in time (weeks rather than months) and authority.
location and where there is epidemiological
evidence of a common source of infection, B5. There are published guidelines on the PHE
with or without microbiological evidence. website for the investigation and management
An outbreak control team should always be of incidents, clusters and outbreaks of
convened to investigate outbreaks. It is the Legionnaires’ disease.
responsibility of the Proper Officer to declare
an outbreak. The Proper Officer, appointed B6. If the hot and cold water system is
by the local authority, is often a consultant in implicated in an outbreak of Legionnaires’
communicable disease control (CCDC) within disease, the WSG may wish to consider
the local PHE centre health protection team. cleaning and disinfection of part of the, or
the entire, system. Advice may be found in
B3. The local PHE centre health protection HSG274 Part 2.
team has established incident plans to
investigate major outbreaks of infectious
diseases including legionellosis.
64
Appendix C Exemplar temperature test sheets
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Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
66
Appendix D Testing for P. aeruginosa
D1. P. aeruginosa may be present within the D7. To maximise the recovery of these free-
water storage, distribution and delivery systems floating planktonic bacteria, water samples
and also in the water supplied to the healthcare should be taken:
facility.
a. during a period of, preferably, no
D2. The sampling protocol (Appendix E) is use (at least two hours or preferably
intended to help healthcare providers establish longer); or
whether the water in augmented care units is
contaminated with P. aeruginosa and, if it is, to b. low use.
help locate its origin and to monitor the efficacy
of remedial measures. D8. If water flows over a biofilm containing
P. aeruginosa located in the last two metres,
D3. P. aeruginosa contamination is generally planktonic bacteria arising from that biofilm
found in the last two metres of the point of will be diluted and a subsequent sample will
water delivery; therefore pre-flush samples give low bacterial counts. If contamination
should be collected to assess the highest risk is upstream in the system, this will not affect
to outlet users and at-risk patients. bacterial counts, which may actually increase.
D4. Biofilm will constantly be released D9. The sample obtained after allowing water
as clumps or free-floating individual cells to flow from an outlet is referred to as a “post-
(planktonic forms).The concentration of flush” sample (see paragraphs E12 and E13
planktonic bacteria will build up over time when in Appendix E). Comparison of counts from
the water is stagnant, but will be diluted as pre-and post-flush samples can help locate
water is used and flows through the pipework the source of the P. aeruginosa. If a pre-flush
or tap containing the biofilm. sample gives a high count, subsequent paired
pre- and post-flush samples should be tested
D5. Water outlets can give very different results to help locate the source of the contamination.
and may be negative if water from the tap has
been used before a sample is collected. D10. In order to be able to carry out the
appropriate microbiological examinations on a
D6. The first water to be delivered from the sample and provide a meaningful interpretation
outlet (pre-flush sample) should be collected to of test results, it is essential that samples
assess the microbial contamination in the last are collected in the correct manner using
two metres of pipework. the correct equipment and that the sampling
protocol in Appendix E is adhered to.
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Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Where to sample water outlets D17. If test results are not satisfactory
(>10 cfu/100 mL), further sampling along with
D12. The water outlets to be sampled should an engineering survey of the water system
be those that supply water which: could be used to identify problem areas and
modifications that may be implemented to
• has direct contact with patients;
improve water quality.
• is used to wash staff hands; or
• is used to fill or clean equipment that will D18. After such interventions, the water should
have contact with patients as determined be resampled (see Figure D1 for suggested
by risk assessment. frequencies).
Note
When and how to sample water
Figure D1 gives an example of sampling
outlets frequencies. Sampling may be undertaken
D13. The outlets identified above should more frequently according to the risk
be sampled to provide an initial assessment assessment. It is important that samples are
of contamination levels. There is no need to taken as described in Appendix E to avoid
sample all taps that are due to be sampled false negative results.
on the same occasion; samples can be taken
in batches on separate occasions. It may
assist the receiving laboratory if the sampling
schedule is agreed beforehand (see Figure D1
and also Appendix F).
68
Appendix D Testing for P. aeruginosa
Risk-assess removing
outlet from service and
retest (pre-/post-flush)
+ve Remediation
Retest (pre-/post-flush)
(see paragraph D22)
Satisfactory:
+ve
–ve Retest at 3 days
no further action
required
–ve
–ve
–ve
Interpretation of pre- and post-flush • If both pre- and post-flush samples from
a particular outlet are >100 cfu/100 mL
counts and other nearby outlets have no or low
D19. High counts in pre-flush samples but counts, this shows that the single outlet
with low counts or none detected at post-flush is heavily contaminated, despite the high
could indicate that areas/fittings at or near the post-flush count. This could be explored
outlets are the source of contamination (see by testing dilutions of pre- and post-
Table D1). flush water samples from this outlet or
by using an extended flush such as for
• A few positive outlets, where the majority five minutes prior to post-flush sampling
of outlets are negative, would also or by taking a post-flush sample after
indicate that the source of contamination disinfection of the outlet as occurs with
is at or close to the outlet. Legionella post-flush sampling.
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Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Table D1 Interpretation of pre- and post-flush counts D20. If the sampling indicates that the water
High P. aeruginosa pre-flush Suggestive of a local water services are the problem, then most outlets
count (>10 cfu/100 mL) and outlet problem
low post-flush count would possibly be positive and other points
(<10 cfu/100 mL) in the water system could then be sampled
High P. aeruginosa pre-flush Suggestive of a problem not to assess the extent of the problem (see
count (>10 cfu/100 mL) and related to a local water outlet
high post-flush count but to a wider problem within
Table D1).
(>10 cfu/100 mL) the water supply system
D21. Figure D2 provides a summary of the
sampling procedure and interpretation of
Note results for P. aeruginosa.
Overlaying sample results onto schematic
drawings of the system may help to identify
the source of contamination and locations
for additional sampling.
70
Appendix D Testing for P. aeruginosa
b. If a water outlet has been taken out of g. Check connections to mixing taps
service because of contamination with to ensure that the supply to the hot
P. aeruginosa, continue daily flushing connection is not supplied from
while the outlet is out of normal use an upstream TMV. In a hot water
to prevent water stagnation and service, a dead-leg will exist between
exacerbation of the contamination. the circulating pipework and hot
connection of a fitting such as a mixing
c. Where practical, consider removal tap. In the case of cold water services,
of flow straighteners. However, the sometimes there will be no draw-off
removal of flow straighteners may from any part of the system and the
result in splashing and therefore entire service is in effect a dead-leg. To
additional remedial action may need minimise the stagnation of water in a
to be taken. If they are seen to be cold water system, it can be beneficial
needed, periodically remove them and to arrange the pipework run so that
either clean/disinfect or replace them. it ends at a frequently used outlet. A
Replacement frequency should be dead-leg may also exist when a TMV
verified by sampling/swabbing. is installed upstream of a mixing tap
(see Figure D3). Depending on the
d. Splashing can promote dissemination activities of the room in which the tap
of organisms, resulting in basin outlets is located, cold water may never be
becoming heavily contaminated. If drawn through the pipe between the
splashing is found to be a problem, cold water connections of the mixing
investigate the causes. Example valve and mixing tap.
causes include:
h. Risk-assess the water system for
i. the tap’s designed flow profile is redundant pipework and dead-legs
incompatible with the basin; (for example, where water is supplied
to both the cold water outlet and a
ii. the tap discharges directly into the
TMV supplying an adjacent blended
waste aperture;
water outlet, as such cold water
iii. incorrect height between tap outlet outlets in augmented care units may
and surface of the basin; be infrequently used). When removing
outlets, the branch hot and cold water
iv. excess water pressure; pipes should also be cut back to the
main distribution pipework in order to
v. a blocked or malfunctioning flow eliminate redundant pipework.
straightener.
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Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Hot water Hot water Cold water Hot water Hot water
return flow supply return flow
Cold water
supply to tap
Manual mixing
tap
(a) (b)
In the case of (a), as the tap lever is moved progressively from
left to right, only cold water will be drawn through initially. When
fully to the right, cold water will cease to flow and water will flow
from the upstream TMV.
In the case of (b), if the lever remains in the fully hot position, as it
is raised to draw-off water, there may never be flow from the
direct cold-water pipe supplying the tap.
Figure D3 Dead-leg formed by the cold pipework when a TMV is installed upstream of a mixing tap
72
Appendix D Testing for P. aeruginosa
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Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
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Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
76
Appendix F Microbiological examination of water samples for P. aeruginosa
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Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
78
Appendix F Microbiological examination of water samples for P. aeruginosa
F16. To confirm other colonies, subculture F19. It will then be the responsibility of the
from the membrane onto a milk cetrimide agar testing laboratory to ensure that these isolates
(MCA) plate and incubate at 37°C for 22 hours are supplied to the typing laboratory (for
± 4 hours. Examine the plates for growth, example, PHE at Colindale) when requested,
pigment, fluorescence and casein hydrolysis and this should be written into the contract for
(clearing medium’s opacity around the testing.
colonies). If pigment production is poor, expose
the MCA to daylight at room temperature
for two-to-four hours to enhance pigment Calculation of results
production and re-examine. F20. Express the results as colonies of
P. aeruginosa per 100 mL of the undiluted
F17. P. aeruginosa is oxidase-positive, sample, for example:
hydrolyses casein and produces pyocyanin
and/or fluorescence. Occasionally atypical non- • for 100 mL sample – the count on the
pigmented variants of P. aeruginosa occur. A membrane;
pyocyanin-negative, casein-hydrolysis-positive,
fluorescence-positive culture should be • for 10 mL of sample – the count on the
regarded as P. aeruginosa. Additional tests may membrane multiplied by 10;
be necessary to differentiate non-pigmented • for 1 mL of sample – the count on the
P. aeruginosa from P. fluorescens (such as membrane multiplied by 100.
growth at 42°C or resistance to C-390,
9-chloro-9-(4-diethylaminophenyl)-10-
phenylacridan or phenanthroline or more Reporting
extensive biochemical tests). See Table F1. F21. If P. aeruginosa is not detected, report as
“Not detected in 100 mL”.
Retention of P. aeruginosa isolates F22. If the test organism is present, report
F18. Where a clinical investigation is underway, as the number of P. aeruginosa per 100 mL.
inform the testing laboratory that the Reports should be specific to P. aeruginosa,
P. aeruginosa isolates and associated sampling and not generic Pseudomonas species.
location information should be retained for
a minimum of three months as they may be F23. The sample reference originally submitted
required for typing at a later date. should be reported with each result.
Table F1
Colony on CN agar Oxidase test Fluorescing on Caseinolytic on Confirmed
MCA MCA P. aeruginosa
NT = No testing necessary
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Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
80
Appendix F Microbiological examination of water samples for P. aeruginosa
Maintain the cold chain during transport of the sample to the laboratory
Process within 2 hours. If not possible, refrigerate within 2 hours, keep at 2–8°C and process
within 24 hours
Filter
Aseptically place the membrane onto the pseudomonas selective and differential agar and incubate at
37°C; examine after 22 hours ± 4 hours and 44 hours ± 4 hours
Count all colonies that produce a green/blue or reddish-brown pigment and those that fluoresce under
UV light (optional)
Subculture non-pyocyanin-producing (green/blue) colonies to MCA and incubate at 37°C for 22 ± 4 hours
Examine the plates for growth, pigment, fluorescence and casein hydrolysis. If pigment production is poor,
expose the MCA to daylight at room temperature for 2–4 hours to enhance pigment production and
re-examine
81
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Health and Social Care Act 2008 (Regulated Activities) 2014. SI 2014 No. 000. HMSO, 2014.
http://www.legislation.gov.uk/ukdsi/2014/9780111117613/contents
Management of Health and Safety at Work Regulations 1999. SI 1999 No. 3242.
82
Appendix F Microbiological examination of water samples for P. aeruginosa
Note
See also Appendix 2 in HTM 04-01 Part A, which gives an overview of UK water legislation.
Health Building Note 00-08 – (Estatecode) Part B: Supplementary information for Part A.
https://www.gov.uk/government/publications/the-efficient-management-of-healthcare-estates-and-
facilities-health-building-note-00-08
83
Health Technical Memorandum 04-01: Safe water in healthcare premises – Part B: Operational management
Health Technical Memorandum 01-04 – Decontamination of linen for health and social care.
Engineering, equipment and validation. 2016.
https://www.gov.uk/government/collections/health-technical-memorandum-disinfection-and-
sterilization
Health Technical Memorandum 04-01 – Safe water in healthcare premises. Part A: Design,
installation and commissioning. 2016.
https://www.gov.uk/government/collections/health-technical-memorandum-disinfection-and-
sterilization
Health Technical Memorandum 07-04 – Water management and water efficiency. 2013.
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/147948/HTM_07-
04_Final.pdf
84
Appendix F Microbiological examination of water samples for P. aeruginosa
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87
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