Malaysian Hospital Accreditation Standards 4th Edition January 2013

SERVICE STANDARD 3 Facility and Biomedical Equipment Management and Safety

PREAMBLE

The Facility shall provide safe, functional and supportive facilities and equipment for their patients, families,
staff and visitors. To ensure this, the physical facilities, equipment and staff shall be effectively managed to
reduce and control hazards and risks, and prevent accidents and injuries.

These services may be provided from within the Facility by either own staff or contract staff, or contracted to
qualified external contractors.

TOPIC 3.1: ORGANISATION AND MANAGEMENT

STANDARD 3.1.1

The Facility and Biomedical Equipment Management and Safety Services shall be organised and
administered to provide optimum maintenance and safety of the Facility in support of its goals, objectives and
values through an appointed designated Head of service.

CRITERIA FOR COMPLIANCE:

3.1.1.1 There are documented purposes which may be termed Vision and Mission statements, goals,
objectives and values that suit the scope of services. When compiling the purposes,
consideration shall be given to the following:

a) They are what the services want to achieve.

b) The goals of the service are achieved by the objectives as stated.

c) The goals and objectives are consistent with professional standards, guidelines and
relevant legislation;

d) Statements are monitored, reviewed and revised as required accordingly.

3.1.1.2 There is an organisation chart which:

a) provides a clear representation of the structure, function and reporting relationships

between the Head and the staff of the Facility and Biomedical Equipment Management
and Safety Services;

b) is available to all staff;

c) includes off-site services if applicable;

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d) is revised when there is a major change in any one of the following:

 organisation;
 functions;
 reporting relationships;
 goals and objectives;
 staffing patterns.

3.1.1.3 There are written and dated specific job descriptions for all categories of staff that include:

a) qualifications, training, experience and certification required for the position;

b) lines of authority;

c) accountability, functions, and responsibilities;

d) review when required and when there is a major change in any one of the following:

 nature and scope of work;

 duties and responsibilities;
 general and specific accountabilities;
 qualifications required;
 staffing patterns;
 Statutory Regulations.

3.1.1.4 Regular staff meetings are held to discuss issues and matters pertaining to the operations of the
Facility and Biomedical Equipment Management and Safety Services. Minutes are kept and
accessible to relevant staff.

3.1.1.5 Personnel records on training, staff development, leave and others are maintained for every staff.

3.1.1.6 The Head of Facility and Biomedical Engineering Management and Safety Services is involved in
the planning, management, and justification of the budget and resource utilisation of the services.

3.1.1.7 The Head of Facility and Biomedical Equipment Management and Safety Services is involved in
the appointment and/OR assignment of staff.

3.1.1.8 The Head of the Facility and Biomedical Equipment Management and Safety Services shall
ensure that the staff complete incident reports which are discussed by the services with learning
objectives and forwarded to the Person In Charge (PIC) of the Facility.

3.1.1.9 Incidents reported have had Root Cause Analysis done and action taken to prevent recurrence.

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3.1.1.10 Appropriate statistics and records shall be maintained in relation to the provision of Facility and
Biomedical Equipment Management and Safety Services and used for managing the services
and patient care purposes.

3.1.1.11 Where services are provided by an external source, there is a written agreement between the
external service provider and the Facility stating the requirements for service delivery, including
the following:

a) formal lines of communication and responsibilities between the external service provider
and the Facility;

b) provision of adequate numbers of appropriately qualified personnel to perform their duties;

c) participation, as appropriate, of the external service provider in committees of the Facility;

d) arrangement for adequate pickup and delivery;

e) arrangements for after-hours and emergency services;

f) mechanisms for dealing with problems in service delivery;

g) adequate facilities and equipment for providing the services at the Facility and at the site
of the external services;

h) involvement of the external service provider in safety and quality improvement activities of
the Facility, as appropriate;

i) comply with the appropriate MSQH Standards of Accreditation for Facility and Biomedical
Equipment Management and Safety Services.

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TOPIC 3.2: HUMAN RESOURCE DEVELOPMENT AND MANAGEMENT

STANDARD 3.2.1

The Facility and Biomedical Equipment Management and Safety Services shall be directed by and staffed with
adequate numbers of appropriately qualified and licensed personnel where required to achieve its aims and
objectives.

CRITERIA FOR COMPLIANCE:

3.2.1.1 The direction by the Head and staffing of the services are provided by individuals qualified by
education, training, experience and certification to meet the demands of the various positions
and to achieve the objectives of the Facility and Biomedical Equipment Management and Safety
Services.

3.2.1.2 The authority, responsibilities and accountabilities of the Head of Facility and Biomedical
Equipment Management and Safety Services are clearly delineated and documented in a letter
of appointment.

3.2.1.3 Sufficient numbers of personnel and support staff with appropriate qualifications are employed to
enable the services to meet the documented purposes.

3.2.1.4 There is a structured orientation programme where new staff are briefed on their services,
operational policies and relevant aspects of the Facility to prepare them for their roles and
responsibilities.

3.2.1.5 There is evidence of a staff development plan which provides the knowledge and skills required
for staff to maintain competency in their current positions as the demands of the positions evolve.

3.2.1.6 There are continuing education activities for staff to pursue professional interests and to prepare
for current and future changes in practice. There is evidence that staff education and
development needs have been appraised and identified.

3.2.1.7 Staff receive written evaluation of their performance at the completion of the probationary period
and annually thereafter, or as defined by the Facility.

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TOPIC 3.3: POLICIES AND PROCEDURES

STANDARD 3.3.1

Documented policies and procedures shall reflect current knowledge and practice for the services, and they
are consistent with the objectives of the Facility and Biomedical Equipment Management and Safety Services,
relevant regulations and statutory requirements.

CRITERIA FOR COMPLIANCE:

3.3.1.1 There are written policies and procedures for Facility and Biomedical Equipment Management
and Safety Services and they are consistent with the overall policies of the Facility.

3.3.1.2 Policies and procedures are developed in collaboration with staff, medical practitioners,
Management and where required with other external service providers and with reference to
relevant sources involved.

3.3.1.3 Policies and procedures are dated, authorised, signed and reviewed at least once every three
years and revised as required.

3.3.1.4 New and revised policies and procedures are communicated to all staff.

3.3.1.5 There is evidence of compliance with policies and procedures.

3.3.1.6 Copies of policies and procedures, relevant Acts, Regulations, By-Laws and statutory
requirements are accessible to staff.

3.3.1.7 The policies and procedures shall include the emergency and contingency plans for the following
outages:

a) water;

b) electricity;

c) medical gas supply.

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TOPIC 3.4: FACILITIES AND EQUIPMENT

STANDARD 3.4.1

Adequate physical facilities and equipment appropriate to the needs of the services shall be made available to
meet the goals and objectives of the Facility.

CRITERIA FOR COMPLIANCE:

3.4.1.1 There is adequate and proper utilisation of space and equipment to enable staff to carry out their
professional and administrative functions.

3.4.1.2 There is documented evidence that equipment complies with relevant national/international
standards, e.g. those set by SIRIM Berhad (Standards and Industrial Research Institute of
Malaysia) and current statutory requirements.

3.4.1.3 There is evidence that the Facility has a comprehensive maintenance programme such as
predictive maintenance, planned preventive maintenance and calibration activities, to ensure the
facilities and equipment are in good working order. The maintenance programme and budget are
reviewed.

3.4.1.4 Where specialised equipment is used, there is evidence that only staff who are qualified and
privileged operate such equipment.

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TOPIC 3.5: SAFETY AND QUALITY IMPROVEMENT ACTIVITIES

STANDARD 3.5.1

The Heads responsible for Facility and Biomedical Equipment Management and Safety Services shall ensure
the provision of quality performance with staff involvement in the continuous safety and quality improvement
activities of the Services.

CRITERIA FOR COMPLIANCE:

3.5.1.1 There is evidence that the Head of the Service has in a written document assigned
responsibilities to appropriate individuals/committees for safety and quality improvement activities
within the services.

3.5.1.2 There are planned and systematic safety and quality improvement activities that monitor and
evaluate the performance of the services including a plan for action and follow up to ensure that
the action taken is effective in continually improving the quality of care. Innovation is advocated.

3.5.1.3 There are safety and quality improvement activities in place which support the Facility’s safety
and quality improvement activities including tracking and trending of specific performance
indicators not limited to but at least two (2) of the following:

a) percentage of planned preventive maintenance being done on schedule (at least 95%)

b) percentage of work orders completed on schedule

Notes/Explanations

Reports are available on indicators include tracking and trending for specific performance
indicators carried out.

3.5.1.4 Feedback on results of safety and quality improvement activities are regularly communicated to
the staff.

3.5.1.5 Appropriate documentation of safety and quality improvement activities is kept and confidentiality
of staff and patients is preserved.

3.5.1.6 There are safety and quality improvement activities that address staff safety.

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TOPIC 3.6: SPECIAL REQUIREMENTS

STANDARD 3.6.1: FACILITY AND BIOMEDICAL EQUIPMENT MAINTENANCE

The Facility is constructed, equipped, operated and maintained in a manner that supports the patient care
objectives and the physical safety and comfort of patients, staff and visitors.

CRITERIA FOR COMPLIANCE:

3.6.1.1 Life cycle costs and utilisation of buildings, plants, and equipment are reviewed and
recommendations made inclusive of equipment categorised as Beyond Economic Repair (BER).
Building facilities and equipment are upgraded and replaced in accordance with relevant
statutory regulations.

3.6.1.2 Operational manuals for plants and equipment are current and accessible.

3.6.1.3 Energy management programme complies with regulatory requirements and should not
compromise safety and comfort of patients and staff.

3.6.1.4 New plants and equipment are checked for compliance with established standards prior to use.

3.6.1.5 A register of plans for plants and equipment is maintained.

3.6.1.6 There is a comprehensive planned maintenance programme including the following

documentation:

a) assets register;

b) work schedule system;

c) schedules and records of maintenance inspections;

d) record of inspections of pressurised vessels;

e) supervision of service contracts;

f) proper calibration of equipment as evidenced by certification.

3.6.1.7 Relevant licences/certificates of fitness are acquired and kept current as required.

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STANDARD 3.6.2: VENTILATION AND AIR CONDITIONING

Where required, air conditioning and ventilation systems shall be installed for the purpose of safety and
comfort after taking into consideration the control of airborne infection. Operating suites, nurseries, special
care units, isolation rooms and laboratories shall be air-conditioned and ventilated in accordance with the
requirements of the relevant Acts, statutory requirements and local building codes.

CRITERIA FOR COMPLIANCE:

3.6.2.1 Water towers associated with air conditioning systems are inspected regularly to ensure they are
clean and free from algae and Legionella bacteria.

3.6.2.2 Where cooling is required for critical service areas, a backup chiller or standby unit chiller,
supplied with essential electrical power supply is required, instead of relying on a single chiller.

3.6.2.3 Air conditioning that uses refrigerant gas as cooling medium shall have a system to detect and
avoid leakage of gas.

3.6.2.4 Air ducts and filters are inspected, cleaned and maintained regularly (i.e. included in the
preventive maintenance programme).

3.6.2.5 Air handling units, fan coil units, exhaust fans, and piping systems are maintained and checked
regularly.

3.6.2.6 Emergency backup power supply shall be made available for the operation of air conditioning
system in critical service areas such as operating theatres, intensive care units, NICU etc.

3.6.2.7 Ventilation

a) All rooms and areas shall be adequately ventilated with minimum six (6) air change.

b) The ventilation system shall be adequate to provide ten (10) air change without re-
circulation in patient rooms or areas in which excessive heat, moisture, odours or
contaminants originate.

c) Microbiology work rooms or areas shall not have any re-circulation of air and shall be air-
conditioned.

d) All fresh air supply inlets shall be so located to ensure a source of fresh air away from any
source of contaminants or odours.

e) Air discharge exhaust shall be located away from air supply intakes or windows to avoid
cross circulation of air.

f) The design and balancing of the ventilation system shall be such as to avoid airflow from
rooms or areas likely to contain contaminants to other patient care rooms or areas, food

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preparation or serving rooms or areas, and rooms or areas containing clean or sterile
supplies and equipment.

g) Where air conditioning is used, air from rooms or areas likely to contain infectious micro-
organisms or noxious gas shall be exhausted to the outside and not re-circulated through
the normal air conditioning system.

h) Where toxic materials are used in a laboratory, the ventilation system shall be capable of
removing toxic and noxious fumes and providing adequate fresh air to the laboratory.

i) All air supplied to critical service areas such as operating theatres, labour-delivery rooms
and nurseries shall be delivered at or near the ceiling of such room or areas served.

j) The ventilation for the newborn nursery shall:

i) have a minimum ventilation rate of twelve air change per hour which is provided by
mechanical supply and exhaust air systems;
ii) have filters with a minimum efficiency of ninety percent in the retention of particles
with a pre-filter of twenty-five percent efficiency rate;
iii) maintain a positive air pressure relative to the air pressure of adjacent rooms or
areas.

k) Operating theatres and its ancillary facility shall be mechanically ventilated to provide one
hundred percent fresh air without recirculation.

l) The operating theatres shall be provided with a minimum ventilation rate of twenty room
volumes of air change per hour by mechanical supply and exhaust air systems, and
outdoor air intakes shall be located as far as practicable but not less than 7.6 metres from
the exhausts from any ventilating system, combustion equipment, medical-surgical
vacuum system or plumbing vent or areas which may collect noxious fumes.

m) The ventilation for isolation room for patients with airborne infection shall:

i) have a minimum ventilation rate of twelve air change per hour which is provided by
mechanical supply and exhaust air systems;
ii) maintain a negative pressure with relative to air pressure of adjacent areas;
iii) the air should flow from cleaner areas into isolation rooms (less clean areas) to
prevent spread of contaminants to other areas;
iv) air from the room should be exhausted to outside or the use of HEPA-filter if re-
circulated.

n) The ventilation for isolation room for immunodeficiency patient shall:

i) have a minimum ventilation rate of twelve air change per hour which is provided by
mechanical supply and exhaust system;
ii) maintain a positive pressure with relative to air pressure of adjacent areas;

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STANDARD 3.6.3: WATER SUPPLY

Clean and potable water shall be available in sufficient quantity.

CRITERIA FOR COMPLIANCE:

3.6.3.1 There is evidence that water supply is microbiologically tested periodically and treated as
necessary. The Facility can obtain the water quality report for water supplied directly from a
public water service provider.

3.6.3.2 The Facility water supply complies with the World Health Organization (WHO) water quality
standards and guidelines and tested by certified laboratory.

3.6.3.3 The Facility’s water supply system shall not be connected with other piping systems or with a
fixture that could allow contamination of the water supply.

3.6.3.4 Drinking water storage tanks are secured and inspected regularly to ensure they are clean and
free from algae. The water shall be maintained at a microbiologically accepted standard. Water
analysis for drinking water shall be done at least once yearly to acceptable standard (e.g. World
Health Organization, WHO).

STANDARD 3.6.4: MEDICAL GASES

Medical gases and medical suction systems shall be made available at pertinent locations, especially patient
treatment areas and critical care areas. There are documented procedures to ensure that medical gases and
medical suction are supplied and delivered in a clean, safe, and reliable manner.

CRITERIA FOR COMPLIANCE:

3.6.4.1 Medical gas and medical suction systems such as liquid oxygen systems, gas manifolds,
compressed air plants, and vacuum plants are inspected and maintained regularly.

3.6.4.2 Staff are trained to operate medical gas and medical suction systems, including identification of
different types of colour coding used for medical gas cylinders, storage, transportation, and
changing of medical gas cylinders.

3.6.4.3 Shut-off valves shall be provided in each main supply line and area branch line. They shall be
located in controlled areas for security reasons and could be readily shut off in an emergency.

3.6.4.4 There is medical gas disaster plan to cope with failure of any medical gas system or shortage of
medical gas supplies. These shall include the following:

a) Warning alarm systems which shall include area alarm system and central alarm system.

b) Backup manifold system comprising primary and secondary banks complete with
changeover system to ensure continuous supply.

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c) Reserve supply capacity and design shall commensurate with hospital requirement and set
out in the operational policy.

3.6.4.5 An active system for anaesthetic gas scavenging shall be provided when nitrous oxide is used for
anaesthesia.

3.6.4.6 The medical gas system shall follow the local regulations or international standards such as
Public Works Department (JKR), Ministry of Health (MOH), HTM 2022, HTM 02-01 and National
Health Services (NHS) CS11.

3.6.4.7 The oxygen gas supply system shall have an auto changeover manifold for primary supply,
emergency standby manifold system as secondary supply, and a back up supply.

STANDARD 3.6.5: VACUUM SYSTEM

CRITERIA FOR COMPLIANCE:

3.6.5.1 The vacuum system shall have:

a) Department of Occupational Safety and Health approval and PMT number;

b) yearly inspection of the system carried out;

c) bacterial filter changed by a competent person.

STANDARD 3.6.6: MEDICAL AIR

CRITERIA FOR COMPLIANCE:

3.6.6.1 The medical air for ventilator shall have:

a) Department of Occupational Safety and Health approval and PMT number;

b) yearly inspection of the system carried out;

c) filters changed by a competent person;

d) emergency standby manifold.

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STANDARD 3.6.7: ELEVATORS

CRITERIA FOR COMPLIANCE:

3.6.7.1 a) There is a certificate (PMA) to verify that elevators comply with requirements of the
Department of Occupational Safety and Health.

b) The number and size of the elevators comply with the requirements of the Private
Healthcare Facilities and Services Act 1998 and Regulations 2006:

i) for patient transportation, the size of such elevator is at least be 1.5 metres by 2.1
metres clear size with a capacity of 1,500 kilograms, car and shaft doors of at least 1.2
metres clear opening;

ii) for transfer of patient-bed with attachments, the size of such elevator are appropriate
to such function.

STANDARD 3.6.8: BUILDING STANDARDS

CRITERIA FOR COMPLIANCE:

3.6.8.1 Ceiling Height

The minimum height of ceiling shall be as stated in the relevant statutory regulations.

a) 2.4 metres minimum clear floor to ceiling height for air-conditioned rooms or areas;

b) 3.0 metres minimum clear floor to ceiling height for non-air-conditioned rooms or areas;

c) 2.7 metres minimum clear floor to ceiling height in operating rooms, labour delivery rooms
and similar rooms having special ceiling-mounted light fixtures.

3.6.8.2 Entrances & Exits

a) Entrances and exits in the Facility shall be located in an area where minimum disturbance is
caused to its patients and entrance for patients and visitors of the Facility shall be adjacent to
the lobby.

b) There shall be at least one entrance which is designed without stairs for the movement of
patients in wheelchairs or on stretcher in the Facility or service.

c) There shall be separate emergency patient entrance, service entrance and patient and
visitors entrance.

d) Emergency patient entrance shall be located for ready access to emergency department or
unit and readily accessible to pedestrian, ambulance and other vehicular traffic.

e) Service entrance shall be located close to storage room or area, elevators and kitchen.
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f) There shall be a separate exit where dead bodies can be removed in an unobtrusive manner.

3.6.8.3 Windows

Windows are required in all patient rooms except labour delivery rooms. Windows allow for
unobstructed natural lights.

STANDARD 3.6.9: ELECTRICAL SYSTEM

CRITERIA FOR COMPLIANCE:

3.6.9.1 Nature of electrical sockets

The type, quantity, location and height of electrical sockets shall be appropriate for the services
to be performed and all sockets shall be of the grounding type. There shall be compliance with
electrical standards for cardiac-protected or body-protected electrical areas in the operating
rooms, interventional cardiology laboratory and critical care units.

3.6.9.2 Number of electrical sockets

a) No adaptors, extension cords and junction boxes shall be permitted in any room or area.

b) There shall be adequate number of electrical sockets with adequate numbers connected
to an emergency source of power:

i) located in operating theatres, nursery, labour-delivery rooms, emergency room and all
intensive care units suitable for the services to be performed;
ii) located at the head of each bed in patient rooms, labour-delivery rooms, recovery
rooms and all intensive care units;

iii) in all nursing units;

iv) for critically needed equipment in all patient care areas;
v) for refrigerators for biologicals;
vi) for x-ray illuminators in each operating theatre room and emergency room.

3.6.9.3 Power supply

a) Uninterrupted power supply shall be provided for life support systems, essential lights in
operating theatres and rooms for interventional procedures.

b) Adequate Insulation Monitoring Device (IMD) or Line Isolation and Overload Monitoring
(LIOM) is an integral part of Isolated Power System (IPS) shall be used and maintained
regularly.

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c) Adequate emergency electrical generator with automatic transfer in case of interruption of

normal power supply shall be provided to the following essential systems, equipment,
rooms or areas:

i) nurses’ call system;

ii) alarm system;
iii) equipment necessary for maintaining telephone service;
iv) fire pump;
v) selected sockets in the vicinity of emergency electrical generating equipment;
vi) selected areas in nurseries, critical care units, intensive care units, cardiac care
units, exhaust systems at isolation rooms, operating theatres, labour-delivery rooms,
emergency rooms, recovery rooms, laboratory, blood bank locations, medicine
dispensing areas, radiology and radiographic rooms, mortuary freezers.

d) Emergency power supply shall also be provided for the illumination:

i) of exit signs, exit directional signs and staircases;

ii) of nurses’ stations;
iii) of corridors in patient care rooms or areas and patient toilets;
iv) in the vicinity of electrical generating equipment.

e) Voltage stabilisers shall be provided in areas where high precision equipment is located.

f) The emergency power shall be in operation within the stipulated time after interruption of
normal power supply.

g) Switch socket outlets shall be differentiated between normal, uninterrupted power supply
(UPS) and emergency power supply and coded according to international standards.

Notes/Explanations

International colour codes for switch socket outlets:

i. normal local supply – white;

ii. uninterrupted power supply (UPS) – yellow;
iii. emergency power supply (EPS) – red.

h) The Facility or services shall provide on site fuel storage which shall have the capacity to
sustain emergency electrical generator operation for eight hours.

i) Electrical generator shall be operated for a minimum of thirty minutes weekly or as

stipulated by the manufacturer including a monthly test under “load” condition and proper
record of tests shall be maintained.

j) Circuit wiring in old buildings requires certification by Supervising Engineer as required by

Energy Commission.

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k) An Energy Manager shall been appointed by the Facility if the electrical consumption is
more than 3MkWh for a period of six months as required under the Efficient Management
of Electrical Energy Regulation 2008, under the Electricity Supply Act 1990.

3.6.9.4 Use of telecommunication device

a) The use of telecommunication devices shall not be permitted within critical care units,
operating theatre and any other room or area where the use of telecommunication device
will disrupt the proper functioning of any equipment in the room or area.

b) The signage relating to the prohibition of the use of telecommunication device shall be
prominently displayed and strictly adhered to.

STANDARD 3.6.10: SEWAGE AND SEWERAGE SYSTEM

CRITERIA FOR COMPLIANCE:

3.6.10.1 No exposed sewer line shall be located directly above clinical areas, working, storing or eating
surfaces in kitchens, dining rooms or areas, pantries, food storage rooms or areas or where
medical or surgical supplies are prepared, processed or stored.

3.6.10.2 Affluent test is to be conducted every six months.

3.6.10.3 As required under the Drainage and Sewerage Act, a competent operator is required to manage
the sewage treatment plant.

3.6.10.4 Water run-off from clinical and domestic waste storage area must be connected to the sewage
treatment plant (STP) of the Facility or municipal sewage treatment plant.

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