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 Rating

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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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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 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.

3.2.1.2

The Head of Facility and Biomedical Equipment Management

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

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