Malaysian Hospital Accreditation Standards

4th Edition January 2012

SERVICE STANDARD 11
TOPIC 11.1: ORGANISATION AND MANAGEMENT STANDARD 11.1.1

Operating Suite Services

The Operating Suite Services shall be organised to provide safe and efficient perioperative care for patients. The services shall be coordinated with other departments and services of the Facility. CRITERIA FOR COMPLIANCE: 11.1.1.1 There are documented purposes which may be termed Vision and Mission statements, Goals and Objectives that suit the scope of the Operating Suite Services. When compiling the purposes, consideration shall be given to the following: a) b) c) d) 11.1.1.2 They are what the services want to achieve. They support and contribute to the goals of the Facility. They are written and consistent with professional standards, guidelines and relevant legislation. They are monitored, reviewed and revised as required accordingly.

There is an organisation chart which: a) b) c) d) provides a clear representation of the structure, function and reporting relationships of the services; is accessible to all staff; includes off-site services if applicable; is revised when there is a major change in: i) ii) iii) iv) v) organisation; functions; reporting relationships; goals and objectives; staffing patterns.

11.1.1.3

There are written and dated specific job descriptions which are communicated to all classifications of staff that include: a) qualifications, training, experience and certification required for the position;
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Malaysian Hospital Accreditation Standards

4th Edition January 2012

b) c) d)

lines of authority; accountability, functions, and responsibilities; review when required and when there is a major change in: i) ii) iii) iv) v) vi) nature and scope of work; duties and responsibilities; general and specific accountabilities; qualifications required; staffing patterns; Statutory Regulations.

11.1.1.4 11.1.1.5

Regular staff meetings are held to discuss issues and matters pertaining to the operations of the Operating Suite Services. Minutes are kept and accessible to all staff. The Operating Suite Services shall be guided by an Operating Theatre Committee (a subcommittee of MDAC) which consists of the anaesthetists, surgeons (surgeons from any discipline) and nursing sister in charge of the Nursing Services. The Operating Suite Services staff are represented on interdepartmental committees and involved in decision making on issues related to the provision of operating suite services. Personnel records on training, leave etc are maintained for every staff. The Head of the Operating Suite Services is involved in the planning, management, and justification of the budget and resources utilisation of the services. The Head of the Operating Suite Services is involved in the appointment and/OR assignment of staff. The Head of the Operating Suite Services shall ensure that the staff of the Operating Suite Services complete and forward incident reports to the Person In Charge (PIC) of the Facility. Incidents reported monthly have had Root Cause Analysis done and action taken to prevent recurrence. The surgical and anaesthetic practices in the Operating Suite Services are consistent with the privileges conferred by the Hospital Credentialing and Privileging Committee and a copy of such privileges conferred must be displayed and readily available for reference. The records maintained by the Operating Suite Services are adequate for clinical, medicolegal, and evaluation purposes and include the following: a) b) A documented system for tissues/specimens sent for laboratory examination. A register of operations performed within the suite.
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11.1.1.6 11.1.1.7 11.1.1.8 11.1.1.9 11.1.1.10 11.1.1.11 11.1.1.12

11.1.1.13

Malaysian Hospital Accreditation Standards

4th Edition January 2012

c) d)

Standard anaesthetic and drug administration records and regulations relating to the control of drugs. A record of the surgical procedure performed and correspondingly this shall be written into the patients medical records. Each record contains details of the procedure and personnel involved, the dressings applied and drainage systems inserted, prostheses used, and the postoperative orders. Such entries in the records are signed with designation of the surgeon and dated accordingly.

11.1.1.14 11.1.1.15 11.1.1.16

Documented evidence of the counting of accountable (e.g. gauze, instruments etc) items used and a copy of the record is included in the patients medical record. Support services such as radiology, pathology, and blood bank are available. Effective communication and relationships with these services are maintained. Appropriate statistics and records shall be maintained and used for managing the services and patient care purposes.

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Malaysian Hospital Accreditation Standards

4th Edition January 2012

TOPIC 11.2: HUMAN RESOURCE DEVELOPMENT AND MANAGEMENT STANDARD 11.2.1 The Operating Suite Services are directed and staffed to achieve the objectives of the services. The staff of the Operating Suite Services have access to appropriate education programmes which maintain and augment their knowledge and skills. CRITERIA FOR COMPLIANCE: 11.2.1.1 The direction and staffing of the services are provided by individuals qualified by education, training, and experience to meet the demands of the position and to achieve the objectives of the Operating Suite Services. The Operating Suite Services are managed by an appropriately trained registered nurse or equivalent who is experienced in operating suite nursing and who preferably has management skills, qualification, or is working towards one. The authority, responsibilities and accountabilities of the Head of Operating Suite Services are clearly delineated and documented in a letter of appointment. Sufficient numbers of qualified personnel and support staff including ancillary and clerical staff are employed to enable the services to meet the documented purposes. There is a structured orientation programme where new staff including medical practitioners are briefed on their services, operational policies and relevant aspects of the Facility to prepare them for their roles and responsibilities. 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 on the positions evolve. There are continuing education activities for staff, as prescribed by any professional or regulatory body, to pursue professional interests and to prepare for current and future changes in practice. There is evidence that staff education and development needs are appraised and identified. Notes/Explanations Examples of such programmes will include but not limited to the following: a) b) c) d) new surgical, anaesthetic, and operating suite procedures; regular fire and evacuation drills; resuscitation techniques; the use of new equipment in surgical operations and its maintenance and calibration;
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11.2.1.2

11.2.1.3 11.2.1.4 11.2.1.5

11.2.1.6

11.2.1.7

Malaysian Hospital Accreditation Standards

4th Edition January 2012

e) 11.2.1.8

infection control.

Professional staff are actively assisted to attend relevant programmes conducted by their professional groups, other related associations, and educational institutions. Where the Facility cannot provide the necessary programme, cooperation is sought from external sources. Staff including specialists receive written evaluation of their performance at the completion of the probationary period and annually thereafter, or as defined by the Facility. These services in a teaching hospital, subject to the requirements of patient safety and comfort, provide for the relevant educational needs of medical undergraduates and postgraduates. Where hospitals have responsibilities in teaching and research, the staff cooperate and participate in these programmes as required.

11.2.1.9 11.2.1.10 11.2.1.11

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Malaysian Hospital Accreditation Standards

4th Edition January 2012

TOPIC 11.3: POLICIES AND PROCEDURES STANDARD 11.3.1 There are written and dated policies and procedures for all the activities of the Operating Suite Services. These policies and procedures reflect the current standards of operating suite practice, relevant regulations, statutory requirements, and the purposes of the services. CRITERIA FOR COMPLIANCE: There are written policies and procedures for the Operating Suite Services and they are consistent with the overall policies of the Facility. 11.3.1.1 Policies and procedures are developed in collaboration with all staff, medical practitioners, Management, other internal and external service providers and relevant sources involved and are consistent with current international standards for perioperative care. New and revised policies and procedures are communicated to all staff. There is evidence of compliance with policies and procedures. Policies and procedures are reviewed at least once every three years and revised as required, signed and dated accordingly. Copies of relevant regulations and statutory requirements are available to staff. Written policies and procedures refer to at least the following: a) b) Clear prior booking system for cases that is understood by all. Development of guidelines to ensure patient and staff safety which include: i) ii) iii) iv) v) vi) vii) viii) ix) x) xi) c) patient transport; patient positioning; drug administration and errors; handling and disposal of sharps; prevention of electrical hazards; prevention of fire and explosion; prevention of anaesthetic equipment hazards; maintenance of scavenging equipment for removal of various vapours and anaesthetic gases; notification of biohazards; prevention of radiation hazards. notice on the prohibition of telecommunication devices in critical areas.

11.3.1.2 11.3.1.3 11.3.1.4 11.3.1.5 11.3.1.6

Compliance to safety check list/Time out

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d) e) f) g) h) i)

Patient identification, with the nature and site of the operation marked and verified by the surgeon and the consent documents checked. Infection control procedures, including aseptic technique, routine and terminal cleaning, and procedures for infectious patients. Counting procedures for accountable items including the procedures to be adopted in the event of incorrect counts. Patient management during recovery from anaesthesia and surgery. The role of the Operating Suite Services in the fire and disaster plans of the Facility. Priorities in the use of operating suite time and space.

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Malaysian Hospital Accreditation Standards

4th Edition January 2012

TOPIC 11.4: FACILITIES AND EQUIPMENT STANDARD 11.4.1 There are adequate physical facilities and equipment for the safe and efficient functioning of the Operating Suite Services. CRITERIA FOR COMPLIANCE: 11.4.1.1 The design of the Operating Suite Services provides adequate space for the reception, anaesthesia induction, surgery, post-surgical recovery, and observation of patients. This shall include: a) b) c) d) e) f) g) h) i) 11.4.1.2 suitable areas for reception and for patients awaiting surgery; operating theatres; recovery area; adequate storage space for equipment, surgical supplies, linen, housekeeping equipment, and pharmaceutical supplies, including the storage of narcotics; areas for administrative office, and where required, teaching facilities; areas for the collection and disposal of used equipment and waste; male and female staff change rooms; staff facilities like tea room, locker area, on-call room; if any of the above are deemed inadequate, there is plan for providing improved staff facilities when the Facility undergoes refurbishment or redevelopment.

The design of the Operating Suite Services supports efficient systems for the management of perioperative services which include: a) b) c) d) OT rooms are treated as clean rooms with yearly performance test undertaken to ensure clean room status are maintained. fire detection, alarm, and suppression systems; fire fighting equipment and appropriate sign posting; Ventilation system should provide positive pressure from the cleanest areas to less clean area. definition of traffic flow patterns and demarcation of sterile and non-sterile zones which enable enforcement of sterility discipline;
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Malaysian Hospital Accreditation Standards

4th Edition January 2012

e) f) g) h) i) j) k) l) 11.4.1.3

ready access for routing emergency patients; adequate means of egress from the operating suite in the event of fire; free movement of patient trolleys throughout the suite with a minimum of cross traffic; reception of the patient in close proximity to the junction of sterile and non-sterile zones. UPS systems in OT areas must be provided with an alarm system at the nurses station which will be triggered when the system is not charged. The medical gas system in the OTs must be monitored to be functioning. The quantity of medical gas terminal units be sufficient as required under JKR and MPH guidelines which adopt HTM 2011, HTM 02-01, NHS C11 Colour coding for electrical outlets must be standardised or at least appropriately labelled.

There are other systems whose requirements include: a) b) c) d) e) adequate numbers of general power outlets distributed according to needs of each area; adequate provision for emergency power for lighting and suction of an appropriate nature complying with current Malaysian Standards; suitable lighting; adequate medical gas and suction supplies complying with current Malaysian Standards. a means of environmental control of temperature and humidity within safe limits for anaesthetised patients undergoing surgery/procedures; environmental control shall ensure that air quality complies with relevant standards for various treatment or functional areas in respect of temperature, relative humidity and particle count.

11.4.1.4

Safety features are available, including: a) compliance with electrical standards for cardiac-protected or body-protected electrical areas, where required; scavenging of anaesthetic gases and vapours; Notes/Explanations Body Protection means basically that every power point needs to be protected by 10milli amp R.C.D.s or a safety switch which is the same as in most houses but more sensitive to earth leakage currents. This includes dental chairs and X-ray machines.

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Malaysian Hospital Accreditation Standards

4th Edition January 2012

b) c) d) 11.4.1.5

regular maintenance and monitoring of facilities and equipment, and a system to respond quickly to breakdown, repair, and replacement; electrical equipment which comply with Malaysian Standards; appropriate shielding and protective clothing are provided in the presence of biohazards or radiographic equipment.

The equipment in the Operating Suite Services includes: a) b) A range of basic and general surgical equipment in quantities sufficient to support the surgical programme. Where specialised equipment appropriate to the surgical procedure is provided by the surgeon such equipment must be checked to comply with the relevant safety requirements and be appropriately sterilised before use. Minimum equipment for anaesthesia as defined by the Malaysian Society of Anaesthesiologists or the College of Anaesthesiology of the Academy of Medicine Malaysia, document, TI (1984); Association of Anaesthetist and other relevant bodies. Emergency and resuscitation equipment and supplies; with clearly defined instructions on how to operate the equipment and there is evidence that staff are trained to use the equipment.

c)

d)

11.4.1.6 11.4.1.7 11.4.1.8 11.4.1.9 11.4.1.10

There is documented evidence that equipment complies with relevant standards, e.g. those set by SIRIM Berhad. There is regular maintenance of electrical services, medical gases, air conditioning, major equipment, emergency and resuscitation equipment. Emergency biomedical equipment is thoroughly tested as a routine, e.g. defibrillators are discharged and output checked every day or after each use, and the results recorded. There is evidence that the facilities and equipment are maintained in good working order and subject to ongoing planned preventive maintenance and calibration. Where specialised equipment is used, there is evidence that only qualified and privileged staff, operate such equipment.

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Malaysian Hospital Accreditation Standards

4th Edition January 2012

TOPIC 11.5: SAFETY AND QUALITY IMPROVEMENT ACTIVITIES STANDARD 11.5.1 The Head of the Operating Suite Services shall ensure the provision of high quality performance with staff involvement in the ongoing safety and quality improvement activities of the Facility. CRITERIA FOR COMPLIANCE: 11.5.1.1 11.5.1.2 There are clearly assigned responsibilities for safety and quality improvement activities within the services. 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. There are safety and quality improvement activities in place which support the Facilitys safety and quality improvement activities including tracking and trending of specific performance indicators which include but not limited to the following indicators: a) timeliness of emergency cases b) OT cancellation rate c) surgical site infection rate d) percentage of unplanned return to operating theatre e) time in waiting area before surgery f) percentage of postoperative complications g) recovery time after surgery h) percentage of late arrivals for surgery i) 11.5.1.4 11.5.1.5 waiting time for surgeons to arrive

11.5.1.3

Appropriate documentation of safety and quality improvement activities is kept and confidentiality of staff and patients is preserved. There are safety and quality improvement activities that address staff safety. BACK TO STANDARDS REFERENCE

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