MSQH 4th Edition: Standard 3- Facility and Biomedical Equipment Management and Safety Survey Questionnaires

Malaysian Hospital Accreditation Programme - Survey Questionnaires 4th Edition January 2013
Service Std 3: Facility and Biomedical Equipment Management and Safety Page 1
SERVICE STANDARD 3: Facility and Biomedical Equipment Management and Safety
Standard No. Survey Item Hospital
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3.1 ORGANISATION AND MANAGEMENT
3.1.1 The Facility and Biomedical Equipment Management and
Safety Services are 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.
3.1.1.1 Vision and Mission statements, goals, objectives and values that
suit the scope of the Facility and Biomedical Equipment
Management and Safety Services have been documented.
These reflect the roles and aspirations of the service and are as
follows:
a) The documented statements of Vision and Mission, goals,
objectives and values 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) represents the structure, function and reporting
relationships between the Head of the Service and the
staff of the Facility and Biomedical Equipment
Management and Safety Services;
b) is accessible to all staff;
c) includes off-site services if applicable;
d) is revised when there is a major change in any of the
following:
 organisation;
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 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 which 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 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 and minutes are
available and made accessible to relevant staff.
3.1.1.5 There is evidence that personnel records on training, staff
development, leave and others are maintained for every staff by
the Facility and Biomedical Equipment Management and Safety
Services.
3.1.1.6 The Head of Facility and Biomedical Equipment Management
and Safety Services is involved in the planning, management,
and justification of the budget and resource utilisation of the
services.

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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 ensures that the staff
complete incident reports with evidence that these are
discussed by the services with learning objectives. These
reports are forwarded to the Person In Charge (PIC) of the
Facility.
3.1.1.9 There is documented evidence that Root Cause Analysis of
incidents have been done and action taken to prevent
recurrence.
3.1.1.10 There are appropriate statistics and records maintained on the
provision of Facility and Biomedical Equipment Management
and Safety Services and there is evidence that these are 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;

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g) adequate facilities and equipment for providing the
services at the Facility and at the site of the external
service;
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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3.2 HUMAN RESOURCE DEVELOPMENT AND MANAGEMENT
3.2.1 The Facility and Biomedical Equipment Management and
Safety Services are directed by and staffed with adequate
numbers of appropriately qualified and licensed personnel
where required to achieve its aims and objectives.
3.2.1.1 The Head and staff of the Facility and Biomedical Equipment
Management and Safety Services fulfil the educational
qualification, training, experience and certification required to
meet the demands of the various positions and to achieve the
objectives of the services. These requirements are documented.
and Safety Services has a letter of appointment which
delineates the authority, responsibilities and accountabilities of
the position.
3.2.1.3 The number of personnel and support staff with the appropriate
qualifications employed are sufficient to enable the services to
meet the documented purposes.
3.2.1.4 There is evidence that 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 has been implemented.
3.2.1.5 There is documented evidence of implementation 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 as evidenced by:
a) Records on staff education and development needs
being appraised and identified are available.

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b) Records on continuing education activities for staff are
available.
3.2.1.7 There is evidence that 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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3.3 POLICIES AND PROCEDURES
3.3.1 Documented policies and procedures 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.
3.3.1.1 There are documented policies and procedures for the Facility
and Biomedical Equipment Management and Safety Services
and they are consistent with the overall policies of the Facility.
3.3.1.2 There is documented evidence that 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 There is evidence of staff acknowledgement that policies and
procedures including new and revised ones 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 Emergency and Contingency Plans
a) Policies and procedures include the emergency and
contingency plans for the following outages:
i) water;
ii) electricity;
iii) medical gas supply.

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b) These plans have been implemented.

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3.4 FACILITIES AND EQUIPMENT
3.4.1 Adequate physical facilities and equipment appropriate to
the needs of the services are made available to meet the
goals and objectives of the Facility.
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 documentation 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 There is evidence that specialised equipment is operated by
staff with appropriate qualification and privileged by the Facility.

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3.5 SAFETY AND QUALITY IMPROVEMENT ACTIVITIES
3.5.1 The Head responsible for Facility and Biomedical
Equipment Management and Safety Services ensures the
provision of quality performance with staff involvement in
the continuous safety and quality improvement activities of
the Services.
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 documented plans for systematic safety and quality
improvement activities that include:
a) Planned activities
b) Data collection
c) Monitoring and evaluation of the performance
d) Action plan for improvement
e) Implementation of action plan
f) Re-evaluation for improvement
3.5.1.3 There are safety and quality improvement activities in place that
include 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
3.5.1.4 There is evidence that feedback on results of safety and quality
improvement activities are regularly communicated to the staff.

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3.5.1.5 Records on safety and quality improvement activities are kept
and confidentiality of staff and patients is preserved.
3.5.1.6 There is documented evidence of safety and quality
improvement activities that address staff safety.

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3.6 SPECIAL REQUIREMENTS
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.
3.6.1.1 Facility and Biomedical Equipment Maintenance
a) There are records on assessment of facilities, buildings,
plants, and equipment including equipment categorised as
Beyond Economic Repair (BER) which are done according
to asset life cycle and cost of operation and maintenance.
b) There is evidence that records are analysed and used for
improvement.
c) There is evidence that recommendations made with
reference to (a) and (b) are implemented for upgrading
and replacement of building, facilities and equipment in
accordance with statutory requirements.
3.6.1.2 Operational manuals for plants and equipment available 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 There are records that new plants and equipment are checked
for compliance with established standards prior to use.
3.6.1.5 There is evidence that a register of plans for plants and
equipment is maintained.
3.6.1.6 There is evidence that comprehensive planned maintenance
programme including the following documentation is maintained.
a) assets register;

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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 available and
current.
3.6.2 Ventilation and Air conditioning
Where required, air conditioning and ventilation systems
are 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 are air-conditioned and ventilated
in accordance with the requirements of the relevant Acts,
statutory requirements and local building codes.
3.6.2.1 There are documented records that regular inspections and
microbiological tests of cooling water towers associated with air
conditioning systems are carried out to ensure they are clean
and free from algae and Legionella bacteria.
3.6.2.2 There are backup chiller or standby unit chillers, supplied by
essential electrical power supply for air conditioning system for
critical service areas.
3.6.2.3 There is a system to detect and avoid leakage of gas where air
conditioning uses refrigerant gas as cooling medium.
3.6.2.4 The planned preventive maintenance programme include the
documentation that air ducts and filters are inspected, cleaned
and maintained regularly and records of implementation are
available.

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3.6.2.5 There are records that air handling units, fan coil units, exhaust
fans, and piping systems are maintained and checked regularly.
3.6.2.6 There is emergency backup power supply 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 general areas of the healthcare facility have minimum
six (6) air change.
b) Ten (10) air change is required for patient rooms or areas
in which excessive heat, moisture, odours or contaminants
originate.
c) Microbiology work rooms or areas are air-conditioned
without any re-circulation of air.
d) Fresh air intake should be away from any source of
contaminants or odours.
e) Air discharge exhaust should be separated from the air
intake or nearby windows.
f) No contamination of the ventilation system from the air
handling unit (AHU) through the ducts to patient care
rooms or area, food preparation or serving rooms or areas,
and rooms or areas containing clean or sterile supplies
and equipment.
g) Air containing infectious or noxious gas are separately
exhausted to safe location e.g. above roof level to avoid
re-circulation.
h) Where toxic materials are used in the laboratory, the fume
cupboard is certified to ensure the air flow is sufficient to
remove the toxic and noxious fumes and fresh air is
supplied to the laboratory.
i) Air supplied to the critical service areas such as operating
theatres, labour-delivery rooms and nurseries have to be
close to the patient care at or near the ceiling of such
room or areas served.

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j) Ventilation for the Newborn Nursery:
i) has 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 have
mechanical ventilation with 100% fresh air supply without
recirculation.
l) Operating theatres require minimum twenty air change per
hour supplied by mechanical supply and exhaust air
systems. The air intake has to be not less than 7.6 metres
away from any exhaust ventilation system.
m) Ventilation for isolation rooms for patients with airborne
infection:
i) have minimum twelve air change per hour which is
provided by mechanical supply and exhaust air
systems;
ii) maintain negative pressure with relative to air
pressure of adjacent areas;
iii) air flow from cleaner area into isolation rooms;
iv) air from room to be exhausted to outside or
equipped with HEPA filters if re-circulated.
n) Ventilation for isolation rooms for immunodeficiency
patient:
i) have minimum twelve air change per hour provided
by mechanical supply and exhaust air systems;
ii) maintain positive pressure with relative to air
pressure of adjacent areas;

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3.6.3 Water Supply
Clean and potable water is available in sufficient quantity.
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’s 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 is not connected to other
piping system or fitted with fixture that could allow contamination
of the water supply.
3.6.3.4 There is documented evidence that:
a) drinking water storage tanks are secured and inspected
regularly to ensure they are clean and free from algae;
b) the water is analysed and tested periodically at least once a
year and maintained at a microbiologically accepted
standard.

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3.6.4 Medical Gases
Medical gases and medical suction systems are 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.
3.6.4.1 There is evidence of inspection and records of regular
maintenance of medical gas and medical suction systems such
as liquid oxygen systems, gas manifolds, compressed air plants,
and vacuum plants.
3.6.4.2 There is documented evidence that staff are trained to operate
medical gas and medical suction systems and to identify the
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 are provided in each main supply line and area
branch line and located in controlled areas for security reasons.
3.6.4.4 There is a documented medical gas disaster plan to cope with
failure of any medical gas system or shortage of medical gas
supplies. These include the following:
a) Warning alarm systems which 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.
c) Reserve supply capacity and design commensurate with
hospital requirement and set out in the operational policy.
3.6.4.5 There is an active system for anaesthetic gas scavenging when
nitrous oxide is used for anaesthesia.

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3.6.4.6 The medical gas system follows the local regulations or
international standards.
3.6.4.7 There is evidence that the oxygen gas supply system has:
a) an auto changeover manifold for primary supply;
b) emergency standby manifold system as secondary supply;
c) a back up supply.
3.6.5 Vacuum system
3.6.5.1 There is evidence that the vacuum system has:
a) Department of Occupational Safety and Health approval
and PMT number;
b) records of yearly inspection of the system carried out;
c) records of bacterial filter changed by a competent person.
3.6.6 Medical Air
3.6.6.1 There is evidence that medical air for ventilator has:
a) Department of Occupational Safety and Health approval
and PMT number;
b) records of yearly inspection of the system carried out;
c) records of filters changed by a competent person;
d) emergency standby manifold.

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3.6.7 Elevators
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.
3.6.8 Building Standards
3.6.8.1 Ceiling Height
The minimum height of ceiling 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; and;
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 are located in an area
where minimum disturbance is caused to its patients and
entrance for patients and visitors of the Facility are
adjacent to the lobby.

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b) There is 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 is separate emergency patient entrance, service
entrance and patient and visitors entrance.
d) Emergency patient entrance is located for ready access to
emergency department or unit and readily accessible to
pedestrian, ambulance and other vehicular traffic.
e) Service entrance is located close to storage room or area,
elevators and kitchen.
f) There is a separate exit where dead bodies can be
removed in an unobstrusive manner.
3.6.8.3 Windows
Windows are required in all patient rooms except labour delivery
rooms. Windows allow for unobstructed natural lights.
3.6.9 Electrical System
3.6.9.1 Nature of electrical sockets
a) The type, quantity, location and height of electrical sockets
are appropriate for the services to be performed.
b) All sockets are of the grounding type.
c) There is compliance with electrical standards for cardiac-
protected or body-protected electrical areas in the
operating rooms, interventional cardiac laboratory and
critical care units.
3.6.9.2 Number of electrical sockets
a) There are no adaptors, extension cords and junction
boxes in any room or area.

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b) There are adequate numbers 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 operation theatre room
and emergency room.
3.6.9.3 Power supply
a) Uninterrupted power supply is 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) is used and
maintained regularly.
c) Adequate emergency electrical generators with automatic
transfer in case of interruption of normal power supply are
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

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rooms, laboratory, blood bank locations, medicine
dispensing areas, radiology and radiographic
rooms, mortuary freezers.
d) Emergency power supply is 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 are provided in areas where high
precision equipment is located.
f) There is evidence of test records that emergency power is
in operation within the stipulated time after interruption of
normal power supply.
g) Switch socket outlets are differentiated between normal,
uninterrupted power supply (UPS) and emergency power
supply and coded according to international standards.
h) The Facility or services have on site fuel storage which
has the capacity to sustain emergency electrical
generators to operate for eight hours.
i) Records have been maintained that the electrical
generators are operated for a minimum of thirty minutes
weekly or as stipulated by the manufacturer including a
monthly test under “load” condition.
j) Certification by Supervising Engineer as required by
Energy Commission for circuit wiring in old buildings is
available.
k) An Energy Manager has been appointed in 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.

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3.6.9.4 Use of telecommunication device
a) There is a policy and evidence of implementation on the
use of telecommunication devices 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 signs relating to the prohibition of the use of
telecommunication device are prominently displayed and
strictly adhered to.
3.6.10 Sewage and Sewerage System
3.6.10.1 Building plans show that there are no exposed sewer lines
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 There is documented evidence that affluent test is conducted
and monitored every six months.
3.6.10.3 There is an operator who has been trained and is competent as
required under the Drainage and Sewerage Act to manage the
sewage treatment plant.
3.6.10.4 There is evidence that water run-off from clinical and domestic
waste storage area is connected to the sewage treatment plant
(STP) of the Facility or municipal sewage treatment plant.

FACILITY AND BIOMEDICAL EQUIPMENT MANAGEMENT AND SAFETY
HOSPITAL COMMENTS
Std. No: __________

SURVEYOR COMMENTS
Std. No: __________

SURVEYOR RECOMMENDATIONS
Std. No: __________

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MSQH 4th Edition: Standard 3- Facility and Biomedical Equipment Management and Safety Survey Questionnaires