Malaysian Hospital Accreditation Standards 4th Edition January 2013

SERVICE STANDARD 19 Central Sterilising Supply Services (CSSS)

PREAMBLE

The Central Sterilising Supply Services provide sterilising services for all areas within the Facility. It shall
comprise of all activities relating to disinfection and sterilisation processes in the Facility. The services shall be
located to:

 Avoid contamination of clean and sterile supplies and equipment.

 Prevent heat and noise to patient care areas.

 Eliminate thoroughfare traffic.

 Facilitate delivery and return of supplies and equipment to and from other services and/or external
facility.

Facilities that do not have their own CSSS Services or cannot provide a full range of services, shall arrange
with an external facility to provide the services needed. The services provided by the external facility shall
comply with the relevant MSQH Standards of Accreditation.

TOPIC 19.1: ORGANISATION AND MANAGEMENT

STANDARD 19.1.1

The Central Sterilising Supply Services (CSSS) is organised and administered to provide optimum support
and service to patient care providers according to the goals and objectives of the healthcare Facility. The
Head of CSSS shall be a healthcare professional with training experience in management, asepsis, supply,
processing and infection control procedures.

CRITERIA FOR COMPLIANCE:

19.1.1.1 There are documented purposes which may be termed Vision and Mission statements, goals,
objectives and values that suit the scope of the Central Sterilising Supply 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.

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19.1.1.2 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 CSSS;

b) is available to all staff;

c) includes off-site services if applicable;

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

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

19.1.1.3 Where sterilisation services are provided in areas other than the main CSSS, for example
operating theatre (OT), Dental Services, responsibility for the operation of these services is the
Head of the CSSS and is clearly defined. Appropriate instructions and supervision of staff,
equipment maintenance and quality control are carried out and documented.

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

a) qualifications, training, experiences 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.

19.1.1.5 Regular staff meetings are held to discuss issues and matters pertaining to the operations of the
CSSS. Minutes are accessible to relevant staff.

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

19.1.1.7 The Head of the CSSS is involved in the planning, management, and justification of the budget
and resource utilisation of the services.

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19.1.1.8 The Head of the CSSS is involved in the appointment and/OR assignment of the staff.

19.1.1.9 The Head of the CSSS shall ensure that the staff of CSSS complete incident reports which are
discussed by the services with learning objectives and forwarded to the Person In Charge (PIC)
of the Facility.

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

19.1.1.11 Appropriate statistics and records shall be maintained in relation to the provision of CSSS and
used for managing the services and patient care purposes.

Standard 19.1.2

Facilities that do not have their own CSSS Services or cannot provide a full range of services, shall arrange
with an external facility to provide the services needed. The services provided by the external facility shall
comply with the relevant MSQH Standards of Accreditation.

CRITERIA FOR COMPLIANCE:

19.1.2.1 The services are approved by the Person In Charge (PIC) of the Facility.

19.1.2.2 The external providers of the CSSS Services shall comply with all relevant MSQH Standards of
Accreditation.

19.1.2.3 Where CSSS are provided by an external source, there is a written agreement between the
external service provider and the Facility stating the requirements for the services that include
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 pick up 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 for decontamination, sterilisation, packing, storage and issuance of
supplies;

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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 CSSS which functions
within the Facility.

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TOPIC 19.2: HUMAN RESOURCE DEVELOPMENT AND MANAGEMENT

STANDARD 19.2.1

The CSSS is managed by a healthcare professional with training and experience in management, asepsis,
supply, processing and infection control procedures.

CRITERIA FOR COMPLIANCE:

19.2.1.1 The Head of CSSS shall be a healthcare professional with training experience and shall be
responsible to coordinate all (on-site or off-site) disinfection and sterilisation processes in the
Facility.

19.2.1.2 The staffing of the CSSS is 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 CSSS.

19.2.1.3 The authority, responsibilities and accountabilities of the Head of CSSS are clearly delineated
and documented in a letter of appointment.

19.2.1.4 Sufficient numbers of personnel with training and experience in central sterilising and medical-
surgical supply services shall be assigned to the central sterilising and medical-surgical supply
facility or service.

19.2.1.5 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.

19.2.1.6 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.

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

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

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TOPIC 19.3: POLICIES AND PROCEDURES

STANDARD 19.3.1

There are documented policies and procedures that reflect current knowledge and practice of CSSS to
achieve its goals and objectives. Policies and procedures shall be consistent with the relevant regulations and
statutory requirements.

CRITERIA FOR COMPLIANCE:

19.3.1.1 There are written policies and procedures for the CSSS and they are consistent with the overall
policies of the Facility.

19.3.1.2 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.

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

19.3.1.4 New and revised policies and procedures are communicated and made accessible to all relevant
staff.

19.3.1.5 There is evidence of compliance with policies and procedures.

19.3.1.6 Policies and procedures of the CSSS should include the following:

a) receiving, disassembling, washing, cleaning and disinfection processes;

b) inspection, functionality check and packing;

c) sterilisation process;

d) validation processes;

e) storage;

f) distribution and traceability;

g) services provided to other healthcare facilities;

h) effective maintenance of sterility (storage condition);

i) shelf life of sterile items appropriate to utilisation (turnover time) and storage condition.

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19.3.1.7 Disinfection and sterilising processes in other services, e.g. Dental Services, TSSU, Endoscopy,
Cardiovascular Laboratory, Fertility Centre etc should be consistent with the requirements of
policies and procedures of the CSSS.

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

19.3.1.9 There shall be no recycling of any disposable medical-surgical instruments, equipment or

supplies.

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TOPIC 19.4: FACILITIES AND EQUIPMENT

STANDARD 19.4.1

There are adequate facilities and equipment to enable the CSSS to meet its goals and objectives in
accordance with regulatory requirements.

CRITERIA FOR COMPLIANCE:

19.4.1.1 The design of the Central Sterilising Supply Services allows for:

a) The CSSS to be equipped and arranged to provide workflow which maintains proper
separation of soiled, clean, unsterile goods for processing, and sterile items with clear
demarcation of the different zones.

b) Areas within CSSS shall be adequate to provide for:

i) Receiving of supplies
 Handling of supplies and equipment in accordance with planned stores and supplies
system and parking of carts.
 Facilities for receiving, disassembling and cleaning of supplies and equipment shall
be located without transporting non-sterile items through sterile areas of CSSS.

ii) Assembling and Packaging

 Facilities for assembling, packaging supplies and equipment shall have at least one
double compartment sink, work counter or its equivalent as required by types and
volume of items.

iii) Sterilising
 Facilities for sterilising shall be located between facilities for assembling and
packaging and facilities for storage of clean and sterile supplies.

iv) Storage
 Facilities for storage of linen and new unsterile supplies.
 Facilities for storage and issue of sterile supplies.

c) Adequate storage space and work benches for equipment, surgical supplies, linen, and
housekeeping materials.

d) Hand washing and staff changing room facilities are readily available to prevent the risk of
cross infection.

e) Suitably planned layout of work benches and equipment so as to prevent the

dissemination of contaminants.

f) Good ventilation system with airflow from clean to soiled areas.

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g) There shall be an exhaust installed over sterilisers to prevent condensation on wall ceiling.

h) Surfaces and overhead areas to be cleaned regularly.

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

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

19.4.1.4 Where autoclave is used, there is evidence that only certified staff operate such equipment.

19.4.1.5 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.

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TOPIC 19.5: SAFETY AND QUALITY IMPROVEMENT ACTIVITIES

STANDARD 19.5.1

The Head of the CSSS shall ensure the provision of quality performance of the service with staff involvement
in the continuous safety and quality improvement activities of the Services.

CRITERIA FOR COMPLIANCE:

19.5.1.1 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.

19.5.1.2 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.

19.5.1.3 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 instrument sets rejected

b) percentage of incidents reported monthly that have had Root Cause Analysis (RCA) done
and action taken to prevent recurrence

Notes/Explanations

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

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

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

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

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TOPIC 19.6: SPECIAL REQUIREMENTS

STANDARD 19.6.1

The CSSS shall be responsible to provide sterilising services and sterile supplies for all areas within the
Facility that use sterile instruments, dressings, linen and other items.

CRITERIA FOR COMPLIANCE:

19.6.1.1 There is evidence of a centralised sterile supply system designed to reduce the risk of infection to
both patients and staff. This system shall be an integral part of the Facility’s infection control
programme that includes:

a) structural layout;

b) building finishes;

c) mechanical and electrical installation;

d) appropriate equipment;

e) clear delineation between sterile and non sterile areas to prevent cross contamination.

19.6.1.2 All sterilising systems (e.g. hot air, steam, gas) are maintained in accordance with statutory
regulations.

19.6.1.3 Linen to be sterilised shall be inspected, folded and assembled into packs in an area set aside for
this purpose, which shall be separate from the main sterilising area. An exhaust system shall be
installed to remove cotton fluff and ensure staff safety.

19.6.1.4 Arrangements are made for supplies required after normal office hours.

19.6.1.5 In the sterile store there is environmental control on ventilation (100% fresh air intake with
positive pressure), temperature (18 - 20ºC ± 2) and humidity (55% ± 5) and the system is
regularly inspected and maintained. Air discharge exhaust shall be located to avoid cross
circulation to air supply intakes or windows.

19.6.1.6 There are special automated equipment appropriate to the CSSS for the cleaning, drying, and
sterilisation of medical equipment and instruments, and they comply with acceptable standards.

19.6.1.7 Mechanical, chemical and biological tests are conducted and results monitored and recorded
accordingly.

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